Patent Publication Number: US-2022211959-A1

Title: Emergency incision and dilation apparatus and method

Description:
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/856,126, filed Jun. 2, 2019 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     This invention was made under a contract with the United States government Department of Defense under DOD Contract No. W81XWH-14-C-0012. The government has certain rights in the invention. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to medical emergency devices, and particularly, to devices that make incisions into and dilate tissue. 
     DESCRIPTION OF THE RELATED ART 
     In some cases, medical emergencies arise in which an incision and dilation of tissue must be performed quickly, such as in a cricothyrotomy. A cricothyrotomy is a medical procedure that involves creating an incision in the cricothyroid membrane. The cricothyroid membrane is a membrane in the neck proximate to what is commonly referred to as the Adam&#39;s Apple. One purpose of a cricothyrotomy is to create an emergency pathway to the lungs of a patient for respiration, when the normal pathway through the nose and/or mouth is compromised. After the incision in the cricothyroid membrane is completed, a tube is place through the incision site and into the patient&#39;s airway. The lungs of the patient may then exchange gas (inhale and exhale) through the tube. 
     Cricothyrotomies are of particular use when time is critical and access to immediate hospital care is not available. Such situations can include, but are not limited to, combat and disaster site situations. Cricothyrotomy kits contain devices that assist in the cricothyrotomy procedure, and are often provided to first responders and field medical personnel. 
     One popular prior art cricothyrotomy kit contains only the basic tools needed to perform an emergency cricothyrotomy. Such kits contain a scalpel, a hook device, and a tube. The scalpel is used to cut the cricothyroid membrane, and the hook device is used to spread the spread the incision site to allow insertion of the tube. While this is technically sufficient, the included tools provide scant protection against many of the common errors that are encountered while performing this procedure on the battlefield, such as misidentification of anatomical landmarks, posterior tracheal perforation, and mediolateral misalignment. In addition, the components are loosely packaged in the kit, relying on the user to recall proper procedural order and equipment usage. This can easily become confusing for the user during a high-stress scenario. 
     Another kit, called the NuTrake is a kit that uses a split-needle design that expands the opening after puncture. This allows for one of three tracheal tubes to be inserted into the surgical airway. While the split needle design eliminates some of the confusion and stress associated with use of the hook device for spreading the opening, it still shares several shortcomings of the basic kit. For example, this device also relies on the manual location of the cricothyroid membrane by the medic or physician. 
     Other devices have attempted to address some of the issues of the basic cricothyrotomy kits, but have their own shortcomings. For example, one device punctures both the skin and the membrane using a sharp metal trocar/obturator that is nested in a plastic cannula. Upon successful puncture, a safety stopper is removed, and the trocar/obturator is removed, leaving behind the plastic cannula. In theory this approach seems to be very beneficial, as it can reduce procedure time compared to traditional approaches. However, in mid-procedure, the only safety stop (which limits the possibility of posterior tracheal perforation), is removed. At this time, the device is not yet fully inserted. The next step requires that the user carefully advance the plastic cannula forward while simultaneously retracting the sharp metal trocar/obturator. This technique may be sufficient for an emergency room or other hospital situation where the patient is secured. However, this method is risky in a battlefield scenario when the possibility of patient movement relative to the device during insertion is highly probable. In addition to this flaw in the device safety, the device also requires that the user angle the device during insertion to help prevent posterior tracheal wall perforation. Should the user omit this step or perform it incorrectly, the patient is at risk for additional injury. 
     Another device is that disclosed is United States Patent Publication No.  2018 / 0008792 , which includes a blade and a dilation tool that can be positioned and guided by a special frame that aligns to the sternal notch. While such a device represents an improvement over the prior art, the blade portion is exposed and can inadvertently move in different ways, which can lead to the requirement of additional training and safety procedures. 
     SUMMARY OF THE INVENTION 
     At least some embodiments address one or more drawbacks of the prior art by providing an incision and dilation arrangement that may be used, for example, in a cricothyrotomy kit, and which features additional safety structures. 
     A first embodiment is an incision and dilation apparatus for performing an incision in and dilating select tissue of a mammal. The apparatus includes a blade member, a dilator, and a frame. The blade member includes a blade having a cutting edge. The dilator is configured to dilate the select tissue. The frame includes a blade guide, and is adapted to position the blade guide over the select tissue. The blade guide retains the blade member in first and second perpendicular directions and allows substantially linear movement of the blade member in a third direction. The frame also supports the dilator and allows movement of the dilator in the third direction. The dilator includes a second blade guide that retains the blade member in first and second perpendicular directions and allow substantially linear movement of the blade member relative to the dilator in a third direction. 
     The second blade guide on the dilator provides a second retention mechanism that helps ensure predictable movement of the blade with respect to the dilator, which is typically part of an incision and dilation procedure. 
     A second embodiment is also an incision and dilation apparatus for performing an incision in and dilating select tissue of a mammal. The apparatus of the second embodiment includes a blame member, a dilator, a frame and a removable clip. The blade member includes a blade having a cutting edge. The dilator is configured to dilate the select tissue. The frame includes a blade guide, and is adapted to position the blade guide over the select tissue. The blade guide retains the blade member in first and second perpendicular directions and allows substantially linear movement of the blade member in a third direction. The frame also supports the dilator and allows movement of the dilator in the third direction. The removable clip extends over and engages a portion the dilator and the blade member to restrict movement of at least the blade member. 
     The above-described features and advantages, as well as others, will become more readily apparent to those of ordinary skill in the art by reference to the following detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a diagram of a neck of a human patient illustrating the location of the cricothyroid membrane; 
         FIG. 2  shows a perspective view of a cricothyrotomy apparatus according to an exemplary embodiment of the invention; 
         FIG. 3  shows a side plan view of the cricothyrotomy apparatus of  FIG. 2 ; 
         FIG. 4  shows a top plan view of the cricothyrotomy apparatus of  FIG. 2 ; 
         FIG. 5  shows a perspective view of exemplary frame of the cricothyrotomy apparatus of  FIG. 2 ; 
         FIG. 6  shows a top plan view of the exemplary frame of  FIG. 5 ; 
         FIG. 7  shows a perspective view of an exemplary embodiment of the dilator of the cricothyrotomy apparatus of  FIG. 2 ; 
         FIG. 8  shows a perspective view of an exemplary embodiment of the blade member of the cricothyrotomy apparatus of  FIG. 2 ; and 
         FIG. 9  shows a perspective view of an exemplary embodiment of the clip member of the cricothyrotomy apparatus of  FIG. 2 . 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 2  shows a perspective view of an incision and dilation apparatus  100  according to an exemplary embodiment of the invention.  FIG. 3  shows a side plan view of the apparatus  100 , and  FIG. 4  shows a top plan view of the apparatus  100 . The incision and dilation apparatus  100  in the exemplary embodiment described herein is intended for use in a cricothyrotomy, and thus has features specific to performing incision and dilation of the cricothyroid membrane. However, it will be appreciated that the incision and dilation apparatus described herein may readily be adapted to perform incision and dilation of other tissue of a human or mammal. 
     With contemporaneous reference to  FIGS. 2-4 , the apparatus  100  includes a frame  102 , a blade member  108 , a dilator  110 , a clip member  111 , a sternal notch alignment piece  112 , and first and second wings  126 ,  128 . The frame  102  further includes a blade guide  104  and a dilator guide  106 . 
     The sternal notch alignment piece  112  is a protuberance, for example, a knob or boss, extending in a downward direction  113  from the frame. In relation to use of the device, the downward direction  113  generally means toward the tissue to be dilated. In this embodiment, the downward direction  113  is the anterior-posterior direction. The protuberance  112  is located at a distance from the blade guide  104  that corresponds to the distance between a sternal notch of an adult human and a cricothyroid membrane of the adult human. The protuberance  112  is sized and configured to be at least partly received and seated by a sternal notch of an adult human, over the skin. It will be appreciated that one or more alternative embodiments can be used with children, having a reduced distance from the protuberance  112  to the blade guide  104 . 
     Referring to  FIG. 1 , the suprasternal notch  4  of a human is located at the superior end of the sternum, and can be easily identified by touch at the base on the anterior portion of the neck. The cricothyroid membrane  2  is located, in adult humans, at a substantially uniform distance from the suprasternal notch  4 , approximately 70 mm, and is between the thyroid cartilage  1  and the cricoid cartilage  3 . Referring to  FIGS. 1 to 4 , the protuberance  112  and the blade guide  104  are configured such that when the protuberance  112  is seated within at least a portion of the sternal notch  4 , the blade guide  104  is aligned over the cricothyroid membrane  2 . 
     As used herein all references to relative positions and directions, namely, anterior, posterior, superior, inferior, medial and lateral, shall be with respect to the proper placement of the apparatus  100  on a human neck, such that the protuberance  112  is seated at least partially within the sternal notch  4 , the blade guide  104  is disposed over the cricothyroid membrane  2 , and the frame  102  extends long the neck portions in between the sternal notch  4  and the cricothyroid membrane  2 . 
     In this embodiment, the blade member  108  is slidably disposed within the blade guide  104 .  FIG. 8  shows a plan view of an exemplary blade member  108 . The blade member  108  includes a blade  160  having a cutting edge  162 , and a blade frame  164 . The blade frame  164  has a first end  164   a,  a second end  164   b,  a sliding bar  165 , a button  166 , and a shoulder  168 . The blade  160  is supported by the blade frame  164  and extends from the first end  164   a  of the blade frame such that a blade edge  162  is external to the blade frame  164 . 
     As shown in  FIG. 8 , the sliding bar  165  extends in the downward (i.e. up-down) direction, and may suitably be formed of molded plastic material. The sliding bar  165  has a generally uniform width, and furthermore has a generally flat front surface  165   a  and generally flat back surface  165   b,  not shown in  FIG. 8  but see  FIG. 3 . Most of the shaft of the blade  160 , not shown is disposed within and rigidly supported by the sliding bar  165 . Although the front surface  165   a  is generally flat, the front surface  165   a  includes an indentation  165   c  configured to receive a clip  250  of the clip member  111  (see also  FIG. 9 ), as will be discussed below. In this embodiment, the indentation  165   c  is a linear channel defined in the medial-lateral direction. However, in other embodiments, the indentation  165   a  may be a round depression or other type of indentation that can seat with portions of a corresponding embodiment of the clip  250 . 
     The button  166  forms a handle/manipulation mechanism and is disposed at the second end  164   b  of the blade frame  164 . The button  166  extends horizontally, such that the button  166  and the sliding bar  165  are substantially perpendicular to each other. As shown in  FIGS. 2 and 3 , the button  166  extends horizontally and over a top surface  172   c  of the dilator  110 , such that a bottom surface  166   a  of the button  166  can engage the top surface of the dilator  110  (see also  FIG. 3 ). The button  166  in this embodiment is a hollow bar having a width sufficient to facilitate structural integrity and digital manipulation. The bottom surface  166   a  of the button  166  is curved. 
     The blade  160  may suitably be a commercially available scalpel blade. In this embodiment, the cutting edge  162  is linear. 
     Referring again to  FIGS. 2-4 , in addition to  FIG. 8 , the blade guide  104  retains the blade  160  generally in the medial-lateral and superior-inferior directions, but allows for sliding movement of the blade  160  within the guide  104  in substantially the anterior-posterior direction  113 . Further detail regarding the blade guide  104  is provided below in connection with  FIGS. 5 and 6 . 
     The shoulder  168  of the blade frame  164  is configured to cooperate with the blade guide  104  to arrest a downward travel of the blade member  108  at a predetermined depth. The predetermined depth of travel distance of the blade member  108  corresponds to an incision by the blade  160  into the cricothyroid membrane when the frame  102  is disposed on a human with the protuberance  112  seated at least partly within the sternal notch  4  (see  FIG. 1 ). The shoulder  168  is configured to interfere with the blade guide  104  such that the blade  160  punctures the cricothyroid membrane  2  but not the posterior tracheal cartilage. 
     Referring to  FIGS. 2, 3 and 7 , the dilator  110  is a non-sharp, curved element that is preloaded into the dilator guide  106  of the frame  102  as shown in  FIGS. 2 and 3 . In general, the dilator  110  includes an elongate curved shaft  170  having a length comparable to that of the blade member  108 , and a head portion  172  at one end. The dilator  110  may suitably be integrally formed of a rigid polymer. The dilator  110  is configured to be depressed (via the head portion  172 ) into the incision in the neck made by the blade member  108 , either nearly at the same time as the incision, or after the blade edge  162  has passed into the neck. The dilator  110  is held inside the access hole in the tissue to maintain the hole before the breathing tube, not shown, is passed into the airway. The elongate curved member  170  of the dilator  110  acts as a backstop to direct the breathing tube into the airway. 
     In this embodiment, the head portion  172  of the dilator  110  includes a second blade guide  171  and first and second handle wings  172   a,    172   b.  As will be discussed below, the second blade guide  171  is configured to retain the blade member  108  in the medial-lateral and superior-inferior directions, while allowing substantially linear movement of the blade member  108  relative to the dilator  110  in the anterior-posterior direction  113 . As will also be discussed below, the first and second handle wings  172   a ,  172   b  form a handle and/or a push bar. 
     The second blade guide  171  in this embodiment includes first and second arms  173  extending out from a main body of the head portion  172 , the arms  173  configured to retain the blade member in the medial-lateral and superior-inferior directions. Each arm  173  includes a bar  173   c  having a first end  173   a  affixed to the head portion  172 , and extends to a second end  173   b  in the superior-inferior direction. Each arm  173  also includes a nub  173   d  extending from a second end  173   b  of the bar  173  along the anterior-posterior direction. It will be appreciated, however, that arms having other geometries may be used to constrain medial-lateral and superior-inferior movement of the blade member  108 . Moreover, it will be appreciated that the second blade guide  171  in the alternative may comprise a closed loop, for example, where the arms  173  are connected by a bar extending from nub to nub. 
     The shaft  170  also includes a depression  170   a  on a rear side thereof, for receiving and engaging the clip  250  (see  FIG. 3 ). In this embodiment, the depression  170   a  is formed as a linear channel similar to the depression  165   c  of the blade member  108 . The depression  170   a  is aligned vertically with the depression  165   c.    
     Referring again to the embodiment, of  FIGS. 2, 3 and 7 , the first and second handle wings  172   a,    172   b  extend outward from a vertical axis of the elongate durved shaft  170 . In general, the handle wings  172   a,    172   b  provide exposed portions of the top surface  172   c  that may be manipulated to allow the blade member  108  to be separated from the dilator  110 . The top surface  172   c  also defines a channel  172   e  receiving the correspondingly shaped portion of the button surface  166   a  of the blade member  108 . Each of the first and second handle wings  172   a,    172   b  have a lower surface  172   d  facing the anterior-posterior direction  113  that can be used as a finger pull. 
     The clip member  111  of this embodiment is shown is described in reference to  FIGS. 2, 3 and 9 . The clip member  111  includes a clip  250 , a shield  252 , and a looped finger pull  254 , integrally formed from molded plastic. 
     The clip  250  is a U-shaped member having opposing first and second clip arms  258  and  260  extending from a back plate  262 . Each of the clip arms  258  and  260  includes a plate  258   a,    260   a  and a jaw  258   b,    260   b.  Each jaw  258   b,    260   b  extends along the length of the plate  258   a,    260   a,  and inward from each corresponding plate  258   a,    260   a  toward the opposite plate  260   a,    258   a.  Each jaw  258   b,    260   b  has a shape corresponding to the depressions  165   c  and  170   a.  Each jaw  258   b,    260   b  has a beveled inner surface at the end to facilitate placement over the depressions  265   c  and  170   a.    
     The shield  252  includes a plate  270  that extends in the downward direction  113  from the removable clip  250 , and specifically, the plate  258   a  of the clip arm  258 . When the clip member  111  is installed (i.e. the jaws  258   a,    258   b  are seated in the depressions  165   c  and  170   a ), the plate  270  extends adjacent to and covers at least the cutting edge  162  of the blade  160  to inhibit inadvertent access thereto, as is shown in  FIG. 2 , for example. The shield  252  further includes at least one nub  272  extending from the plate  270 , such that when the clip member  111  is installed, the nub(s)  272  are adjacent to an underside of the blade guide  104  of the frame. The nubs  272  engage the frame to inhibit movement of the clip member  111 , the blade member  108 , and the dilator  110  vertically upward while the clip  111  is installed. 
     The finger loop  254  is configured to receive a human finger, and extends from the back plate  262  in a direction away from the clip arms  258 ,  260 , or in other words, away from the open end of the clip  250 . The finger loop  254  is used to provide leverage to remove the clip  250  from the installed position to allow the apparatus  100  to be used for the cricothyrotomy procedure. 
       FIG. 5  shows a perspective view of the frame  102  apart from the blade member  108 , the dilator  110 , and wings  126 ,  128  to provide additional clarity.  FIG. 6  shows a plan view of the frame  102 . With simultaneous reference to  FIGS. 2, 5, and 6 , the frame  102  includes a tail member  202 , a jig  204 , a first arm  206 , a second arm  208 . The tail member  202  is disposed at a first (inferior) end  210  of the frame  102 , and the jig  204  is disposed at an opposing second (superior) end  212  of the frame  102 . The protuberance  112  extends posteriorly from the tail member  202 . The blade guide  104  and the dilator guide  106  are formed in the jig  204 . 
     In particular, the jig  204  includes structural supports  226 ,  228  that extend medially, respectively, from the first arm  206  and second arm  208  to a central portion  230 . The central portion  230  of the jig  204  includes the blade guide  104  and the dilator guide  106 . 
     The dilator guide  106  is a sheath-like structure formed in the central portion of jig  204  having a curved channel  214  located medially on the jig  204 . The channel  214  slightly concave toward the inferior direction, and forms a retaining channel for the elongate curved element  170  of the dilator  110 , which is configured to slide in the anterior-posterior direction within the channel  214 . (See  FIG. 2 ). The channel  214  is largely formed by two spaced walls, an inferior wall  216  and a superior wall  218 . 
     The central portion  230  of the jig  204  also includes two opposing notched extensions  220 ,  222  extending from the inferior wall  216 . Each of the notched extensions  220 ,  222  define a corresponding notch  224   a,    224   b  having open ends that face each other. The notches  224   a  and  224   b  collectively form the blade channel of the blade guide  104 . The notched extensions  220 ,  222  cooperate with the blade shoulder  168  to limit the posterior travel of the blade  160 . (See also  FIGS. 3 and 8 ). The blade  160  otherwise slidably moves within the blade channel notches  224   a,    224   b  when manipulated by the handle  166 . The blade  160  is configured to seat within the channel notches  224   a,    224   b  without sliding in the absence of applied pressure, using tension and/or stiction. To this end, the blade  160  may have a width that slightly exceeds that of the channel defined by the notches  224   a,    224   b.    
     The rear wall, or superior wall of the central portion  230  includes a medial notch  232  that allows for digital manipulation of the handle element  172  of the dilator  110  and blade handle  166 . The bottom wall of the central portion  230  includes opposing inclined portions  230   a,    230   b  and rounded concave intersection  230   c  therebetween. The portions  230   a,    230   b,  and  230   c  collectively define a posterior facing curve in the bottom that can be used to help seat the frame  102  medial-laterally on the thyroid/neck. Thus, this curve  230   a,    230   b,  and  230   c,  in combination with the protuberance  112 , assist in proper placement of the apparatus  100  on the human neck. 
     The first arm  206  extends from the first end  210  of the frame  102  to the second end  212  of the frame  102 . More specifically, the first arm  206  extends from the support element  226  of the jig  204  to the tail member  202 . In this embodiment, the first arm  206  forms the structural member that connects, and thus defines the spacing between, the protuberance  112  on the tail member  202  and the blade guide  104  of the jig  204 . The first arm  206  includes a straight beam  234  extending substantially in the inferior direction from the end of the support member  226 . The straight beam  234  includes a central throughhole  236  which allows for the secure, overmolded, connection of the first wing  126 . The underside of the straight beam  234  has a series of three concave depressions  234   a,    234   b,    234   c.  The first arm  206  also include a connector beam  238  that extends at an angle from the end of the straight beam  234  to the tail member  202 . It will be appreciated that the throughhole  236  could be replaced by an indent that serves the same purpose. 
     In this embodiment, the second arm  208  forms the structural member that provides support, but does not connect the tail member  202  and the jig  204 . The second arm  208  includes a straight beam  240  extending substantially in the inferior direction from the end of the support member  228 . The straight beam  240  is substantially identical to the straight beam  234 , and thus also includes a central throughhole  242  (or indent) which allows for the secure, overmolded, connection to the second wing  128 . The underside of the straight beam  240  has its own series of three concave depressions  240   a ,  240   b,    240   c.  The second arm  208  also includes a nub  244  of a connector beam that extends at an angle from the end of the straight beam  240 , but stops short of the tail member  202 . 
     The first arm  206  and second arm  208  thereby form a partial lateral enclosure around an open interior  246  of the frame  102 . The discontinuity or void  248  formed between the nub  244  and the tail member  202  defines a passage through which a breathing tube, not shown, may pass out of the open interior  246  when the breathing tube is in place in the patient. This allows the apparatus  100  to be easily removed by lateral movement after the tube is inserted into the opening in the neck formed by the blade member  108  and dilator  110 . Thus, the void  248  has a width that exceeds that of a breathing tube used for cricothyrotomies, the width of which would be known to those of ordinary skill in the art. 
     Referring again primarily to  FIGS. 2 to 4 , the wings  126 ,  128  are semi-rigid, slightly tacky wings or flaps configured to inhibit slippage of the apparatus  100  device during the procedure. The flexible wings  126 ,  128  are preferably formed by overmolding onto the more rigid frame  102 . In this embodiment, the first wing  126  includes a two to four inch flap having rows and columns of protuberances or bumps  174  to aid in gripping strength. The second wing  128  has a substantially analogous structure. 
     In operation, the apparatus  100  is packaged for use such that the blade member  108  is preloaded in a blade guide  104  and the dilator  110  is preloaded in the dilator channel  106  as shown in  FIGS. 2-4 . To perform the procedure, the user first positions the preloaded apparatus  100  on the patient. To this end, the user aligns the frame  102  on the patient (see  FIG. 1 ) using the protuberance  112 , which seats in the sternal notch  4  of a patient. The user also seats the curve on the bottom wall of the central portion  230  on the trachea. The user then presses down on the wings  126 ,  128  to hold the frame  102  stable in position during the incision and tube insertion procedure. In position, the frame  102  seats along the midline of the neck across the trachea of a patient, such that all or part of the concave depressions  234   a,    234   b,    234   c  of the first arm  234  and the corresponding depressions  240   a,    240   b  and  240   c  on the second arm  240  contact the skin. It will be appreciated that the open interior  246  allows for the neck to be visible and palpated while the apparatus  100  is held to the anatomy. 
     With the apparatus  100  in position (with the protuberance  112  seated at least in part in the sternal notch  12 ), the user first removes the clip member  111  by pulling on the finger loop  254 . With the clip  250  removed from the depressions  170   a,    165   c,  the nubs  272  and clip  250  no longer inhibit vertical movement of the blade member  108  and dilator  110 . 
     The user then depresses the blade member  108  (via button  166 ) such that it travels posteriorly along the channel  224   a,    224   b  of the blade guide  104 , keeping the apparatus  100  aligned as the blade  160  is pressed into the tissue. The bottom surface  166   a  of the button  166  also causes the dilator  110  to travel downward or posteriorly. The travel of the blade member  108  stops at a predetermined depth when the shoulder  168  strikes the notched extensions  220 ,  222 . It will be appreciated that interfering features of the blade member  108  and the blade guide  104  that stop the travel of the blade member  108  may take other suitable forms. In any event, the blade  160 , shoulder  168  and blade guide  104  are configured such that the blade edge  162  does not perforate the posterior trachea. The blade  160  is designed to operate to a certain depth to allow cutting through overlying tissue anterior to the cricothyroid membrane and into the hollow cavity in the trachea. 
     The user then applies pressure to the exposed portions of the upper surface  172   c  of the handle wings  172   a,    172   b  of the dilator  110 . The user then lifts the button  166  to remove the blade  160  following the perforating procedure while pressing down on the upper surface  172   c.  Accordingly, the dilator  110  remains in place with the blade  160  removed to keep the airway open for placement of the breathing tube, or tracheal tube. Once the blade  160  is removed, the tracheal tube is placed into the patient&#39;s airway with the dilator  110  to guide the tube into the appropriate position in the patient&#39;s trachea. The user may then use the handle wings  172   a,    172   b  to remove the dilator  110  from the patient&#39;s anatomy once the tube has been inserted into the trachea. Thereafter, the frame  102  may be moved away from the patient by laterally moving the frame  102  such that the in-place tube passes through the void  248 . 
     The tube or breathing tube referred to herein may suitably be a  220  mm long polymer tube suitable for use for oral and nasal intubation and which has an inner diameter of 5.5 mm to 7.0 mm, and preferably 6.0 mm or 6.5 mm. The tube may also include an inflatable outer bag (and corresponding inflator) near the distal end which may be inflated to block the open airway interior that is exterior to the tube&#39;s outer diameter to ensure a direct pathway between the lungs and the exterior through the operative ends of the tube. Such tubes for use in cricothyrotomies are known to those of ordinary skill in the art. The tube in one embodiment also includes a throughhole in the side, between the distal end and the inflatable outer bag. 
     The cricothyrotomy apparatus and procedure discussed above may be used during emergency when other forms of establishing an airway are not possible or contraindicated. Such conditions may arise at a battlefield, in an ambulance, or at the site of the injury. One advantage of some embodiments is that the system provides a compact, low-cost, intuitive device that allows the user to make an accurate incision and quickly insert the tube into the patient&#39;s airway. 
     The frame  102  is preferably formed by injection molding of a hard polymer such as a polycarbonate ABS alloy. The wings  126 ,  128  are overmolded onto the frame  102  and are formed of a soft, tacky polymer such as a thermoplastic urethane. The blade member  108 , the dilator  110 , and the clip member  111  are separately formed using conventional techniques, such as molding. The blade member  108  and the dilator  110  are at least partially inserted into the frame  102  before use, with the clip member  111  in place, as shown in  FIG. 2 . As such, the apparatus  100  has a single piece construction that is ready to use. 
     It will be appreciated that the above-described embodiments are merely illustrative, and that those of ordinary skill in the art may readily define their own implementations and modifications that incorporate the principles of the present invention and fall within the spirit and scope thereof.