Abstract:
An emergency ventilation apparatus, system, and method for providing ventilation to patients in emergency situations, the system comprising an angled laryngoscope handle and a ventilation-aid securement device. The handle is configured to hold a laryngoscope blade between approximately twenty and forty degrees relative to a lower portion of the handle for more effective intubation of patients. The securement device fits atop a portion of a ventilating mask and is adjustably secured to the patient fitted with the mask by an adjustable strap or similar device. The securement device fits flexibly over the mask providing a seal between the mask and the patient&#39;s face. A version of the securement device includes a thumbscrew for engaging with the mask to secure it. Another version of the securement device is further capable of securing an endotracheal tube to a patient using a thumbscrew to advance a retaining arm for engaging the tube.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority to provisional application 61/023,942, filed Jan. 28, 2008, entitled Emergency Ventilation and Training Device, System, and Associated Methods. 
    
    
     BACKGROUND 
     The present invention relates to emergency devices and methods for ventilating patients, particularly to laryngoscope handles and devices for securing a mask or endotracheal tube to a patient to provide ventilation. 
     Note that herein all references made to “oxygen” are to be understood to include “air” as well. 
     Conventional masks used to supply oxygen to a patient are fitted over the nose and mouth of the patient and typically use one or more elastic bands placed behind the patient&#39;s ears or around the head to secure the mask to the patient&#39;s face. Oxygen is fed into the mask through a tube. 
     One commonly-used type of ventilation device utilizing a mask is a bag-valve-mask, also called a BVM. The bag-valve-mask is a hand-held device used to provide ventilation to a patient who is not breathing or who is breathing inadequately. The bag-valve-mask is a normal part of a resuscitation kit for trained professionals, such as ambulance crews. The bag-valve-mask is also frequently used in hospitals and is an essential part of a crash cart. 
     The bag-valve-mask consists of a flexible air chamber attached to a mask via a shutter valve. When the air chamber or “bag” is squeezed, the device forces air through the mask and into the patient&#39;s lungs. When the bag is released it self-inflates, drawing in either ambient air or a low pressure oxygen flow supplied from a regulated cylinder. In response, the patient&#39;s lungs deflate through the one way valve. 
     A bag-valve-mask without the mask is called a bag-and-valve combination. The bag-and-valve combination, absent the mask, can be attached to an alternate airway adjunct, such as an endotracheal tube. In this way, an endotracheal tube can be used in place of a mask, as discussed below. 
     When ventilating a patient using a mask, the mask is positioned and secured over the patient&#39;s nose and mouth to obtain a good seal so as to ensure oxygen does not escape from around the mask. One common method for obtaining a seal is called a “CE” clamp formation. The CE clamp formation involves using the index finger and thumb on the mask, forming a “C,” and remaining on the jaw line, forming an “E,” to secure the mask to the patient. A proper CE clamp can be even more difficult to maintain if the caregiver with smaller hands is required to provide adequate oxygen flow or tidal volume through the use of a bag-valve-mask or similar device. Other factors can also interfere with providing an effective seal around a mask, such as the position of accident victims, as when in an upright seated position. 
     During surgery, and in emergency situations, it may become necessary to intubate a patient. This is particularly true in emergency situations where a patient&#39;s mouth, throat, or tracheal passage becomes blocked by blood, mucus, or other obstruction. Intubation is the process of inserting an endotracheal tube into the trachea of the patient to provide a clear airway to the patient&#39;s lungs. Oxygen is then supplied through the tube. Intubation usually requires general anesthesia and muscle relaxation, but can be achieved in a conscious patient with anesthesia. In an emergency situation, intubation can be performed without anesthesia, although this is uncomfortable for the patient. Intubation is usually performed by first visualizing the larynx using a handheld laryngoscope. 
     The laryngoscope is typically comprised of two parts, a handle and a removable blade. The handle is typically made of metal and in the approximate shape of an elongated cylinder with a hollow chamber for holding batteries to power a light commonly found on the blade. The removable blade is elongated and generally made of metal. The two main types of blades used in a laryngoscope are curved blades and straight blades. A base of the blade attaches to a top of the handle, with the base of the blade aligned basically perpendicular to the handle. 
     To begin intubation, a blade is selected and connected to the laryngoscope handle. The handle and blade are then used to visualize the larynx so that the patient can be intubated. The caregiver first opens the patient&#39;s mouth and inserts a tip of the blade into the mouth and slides the blade to the base of the tongue. Given the angle of the blade to the handle, the handle will be transverse to the mouth as the blade is inserted. This partially obscures the caregiver&#39;s view of the mouth, which sometimes results in the caregiver striking and damaging the patient&#39;s teeth or lip with the blade. To bring the larynx into view, the patient&#39;s chin is lifted upwards and forward at the same time. The blade is then properly located in the patient&#39;s mouth with the precise location dependent upon the type of blade used. With the blade properly positioned, the caregiver can now apply a degree of force to the handle to lift the patient&#39;s upper jaw. The handle is raised upwardly and away from the patient to an angle of approximately forty-five degrees relative to the patient&#39;s mandible. At this point, the larynx should come into view. 
     A common technique used by caregivers in raising upwardly on the handle is to grip the handle near the blade so as to have more control over the blade and then twisting the wrist to pull the handle upwardly. Again, the shape of the handle can obscure the caregiver&#39;s view of the trachea as the handle is transverse to the mouth. Sometimes this twisting of the wrist can lead to a tendency to use the teeth as a fulcrum for the laryngoscope, which can cause damage to the teeth. 
     Once the larynx is in view, the endotracheal tube is placed through the mouth and down into the trachea between the vocal folds. An end of the endotracheal tube is equipped with an inflatable cuff. When a top end of the cuff clears the vocal folds, insertion of the endotracheal tube is halted and the cuff is inflated. The cuff provides a seal to prevent aspiration and leakage of oxygen. The laryngoscope is removed, and the opposite end of the endotracheal tube is attached to an oxygen source, such as a bag-and-valve combination. 
     It is now important that the endotracheal tube be secured in a stable position, likely for an extended period of time. Unintended movement of the endotracheal tube can harm delicate tissues in the patient&#39;s trachea. It is also important, especially in emergency situations, that the caregiver&#39;s hands remain free to perform other treatment. 
     Typically, tape is wrapped around the endotracheal tube and also attached to the facial area around the mouth to secure the endotracheal tube in place. Unfortunately, if the taping is done incorrectly the tube can move about in the patient&#39;s mouth and irritate the trachea. In addition, the very flexibility of the adhesive tape itself can permit some lateral movement of the endotracheal tube. Another concern is that saliva can collect on the tape and cause the tape to lose adhesion, requiring it to be reapplied. Such periodic reapplication can irritate the patient&#39;s skin. Making adjustments to the endotracheal tube also generally requires removal and reapplication of the tape. Removing the tape, however, cannot ordinarily be done rapidly, as might be necessary in an emergency situation. The tape also hinders access to the mouth area for such care as suctioning out the mouth. 
     As an alternative to tape, a tube-holding device can be used to secure the endotracheal tube in position. Many such devices exist in the prior art. Typically, after the endotracheal tube has been inserted through a patient&#39;s mouth and down into the trachea, a tube-holding device having a generally central opening is lowered over the tube. The device is secured over the mouth using adhesive tape, one or more bands wrapped about the patient&#39;s head, or some other way of fastening. The tube is then secured in position within the device by such means as adhesive tape or a clamp surrounding the central opening of the device. Other means for securing the endotracheal tube are also possible. For example, one prior art device uses a thumbscrew to contact the tube and thereby secure it. Some tube-holding devices also incorporate a bite block secured to a face plate. The face plate generally covers a substantial portion of the face around the patient&#39;s mouth while the bite block is inserted into the mouth. A disadvantage of the bite block is that it can sometimes cause trauma to the interior of the mouth. 
     There is a need, therefore, for a device that secures a mask to a patient&#39;s face in a manner that ensures a good seal around the mask in emergency situations and that frees up the hands of a caregiver to attend to other treatment needs. There is also a need for a device to secure an endotracheal tube to a patient in a manner that prevents substantial movement of the tube once installed, that allows for easy repositioning of the installed tube, and that offers a minimum of skin irritation and mouth trauma. There is a further need for a laryngoscope handle that allows for better viewing of the inside of the mouth so as to effect an easier installation of an endotracheal tube without causing undue injury, as well as a handle that provides better leverage for lifting the jaw, thereby relieving a tendency to use the teeth as a fulcrum and thus causing damage. 
     SUMMARY OF THE INVENTION 
     In accordance with the present invention, a system for providing emergency ventilation to patients includes a ventilation-aid securement device and an angled laryngoscope handle. A ventilation-aid securement device is provided that ensures a good seal around a ventilating mask in emergency situations while at the same time securing the mask to a patient&#39;s face, thereby allowing a caregiver to attend to other treatment needs. The ventilation-aid securement device is also capable of securing an endotracheal tube to a patient in a manner that prevents substantial movement of the installed tube, that allows for easy repositioning of the installed tube, and that offers a minimum of skin irritation and mouth and throat trauma. 
     An angled laryngoscope handle is also provided that allows for better viewing of the inside of a patient&#39;s mouth and the trachea so as to effect easier installation of an endotracheal tube, helping avoid undue injury to the teeth and lip. The angled handle also provides better leverage for lifting the patient&#39;s jaw, thereby relieving a tendency of caregivers to use the teeth as a fulcrum and again causing damage. 
     The system for providing emergency ventilation to patients provides a ventilation-aid securement device and an angled laryngoscope handle to give healthcare professionals greater opportunity to provide effective care for patients while reducing the potential for causing undue injury as a result of intubation. 
     The ventilation-aid securement device fits atop a ventilating mask fitted to a patient&#39;s face. An adjustable securing device, such as an adjustable strap, is attached to the securement device at one end while the unattached end is fitted around the patient&#39;s head and then also attached to the securement device. The strap can be adjusted to apply more or less pressure on the securement device to hold the mask securely to the patient&#39;s face. 
     A flexible face plate of the securement device contacts a surface of the mask and bends downwardly as pressure is applied to the device by the adjustable strap. This flexibility allows the securement device to better conform to the surface of the mask, thereby better distributing the downward force to help hold the mask in place on the face. The configuration of the ventilation-aid securement device allows the device to adapt easily to different styles and shapes of masks. 
     A version of the ventilation-aid securement device is also capable of securing an endotracheal tube to a patient. Following intubation, the securement device is lowered over an end of the installed tube and placed against the patient&#39;s mouth and facial area adjacent to the mouth. A thumbscrew works with a retaining arm to secure the endotracheal tube in position. Again, an adjustable securing device, such as an adjustable strap, is attached to the securement device at one end while the unattached end is fitted around the patient&#39;s head and also attached to the securement device. The strap can then be adjusted as needed. 
     The angled laryngoscope handle is used to prepare a patient for intubation. The base of a laryngoscope blade is secured in an upper portion of the handle at an angle between approximately twenty and forty degrees relative to a lower portion of the handle. This is in contrast to typical prior art handles that are angled virtually perpendicular to the base of their installed blades. The angled handle allows for a better view of the mouth and the trachea than prior art laryngoscope handles. In addition, the handle provides greater leverage in lifting the jaw of a patient than prior art handles, due to the angle of the handle. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       The novel features which are believed to be characteristic of this invention are set forth with particularity in the appended claims. The invention itself, however, both as to its organization and method of operation, together with further objects and advantages thereof, may best be understood by reference to the following description taken in connection with the accompanying drawings, in which: 
         FIG. 1  is a top plan view of a ventilation-aid securement device absent a retaining arm, in accord with the present invention; 
         FIG. 2  is a left side perspective view of a patient fitted with a mask secured in place by the ventilation-aid securement device shown in  FIG. 1 ; 
         FIG. 3  is a right side elevational view of a patient being prepared for intubation using a laryngoscope handle, in accord with the present invention, fitted with a laryngoscope blade; 
         FIG. 4  is top plan view of the ventilation-aid securement device shown in  FIG. 1  equipped with the retaining arm; 
         FIG. 5  is a bottom perspective view of the head of the patient shown in  FIG. 3  now intubated with an endotracheal tube secured in place by the ventilation-aid securement device shown in  FIG. 4 ; 
         FIG. 6  is a left side perspective view of  FIG. 5 ; 
         FIG. 7  is a perspective view of a second embodiment of a ventilation-aid securement device, in accord with the present invention; 
         FIG. 8  is a side elevational view of the ventilation-aid securement device shown in  FIG. 7 ; and 
         FIG. 9  is a left side perspective view of a patient fitted with a mask secured in place by the ventilation-aid securement device shown in  FIG. 7 . 
     
    
    
     DESCRIPTION 
     Note that herein all references made to “oxygen” are to be understood to include “air” as well. 
     Embodying the principles of the present invention is a system for providing emergency ventilation to patients comprising a ventilation-aid securement device and a laryngoscope handle. A preferred embodiment of the system is depicted in  FIGS. 1-6  and designated generally by reference numeral  10 . 
     Referring now to  FIG. 1 , the emergency ventilation system  10  includes a ventilation-aid securement device  36  for securing a ventilating device  14 ,  22  (see  FIGS. 2 ,  5 , and  6 ) to a patient  60  (see  FIGS. 2 ,  3 ,  5 , and  6 ), such as an endotracheal tube  14  (see  FIGS. 5 and 6 ) or a ventilating mask  22  (see  FIG. 2 ). In the present embodiment, the securement device  36  is envisioned to be made of flexible plastic. In alternate embodiments, however, other flexible materials might be used to construct a ventilation-aid securement device  36 . 
     Continuing with  FIG. 1 , the securement device  36  includes an elongated face plate  40  that is generally rectangular and approximately one-half inch thick. The face plate  40  is dimensioned to cover the mouth  61  (see  FIG. 2 ) and immediate surrounding facial area of a patient  60 . The face plate  40  is flexible so as to conform to a curved surface, such as a surface of a ventilating mask  22  or the mouth  61  and surrounding facial area of the patient  60 . The face plate  40  has opposing side portions  43 , each containing a strap opening  42  for receiving an end portion  38 ,  39  (see  FIGS. 2 ,  5 , and  6 ) of a strap  37 . 
     Referring now to  FIG. 2 , the securement device  36  also includes the adjustable strap  37 . The strap  37  is placed around the head of the patient  60  and adjustably attached to the securement device  36 . A first end portion  38  of the strap  37  is attached to a first strap opening  42  of the face plate  40 . A second opposing unattached end portion  39  (see  FIG. 5 ) of the strap  37  is equipped with Velcro® permitting the second end portion  39  to be passed through a second strap opening  42  and adjustably secured there. Note that in alternate embodiments, other fastening modes might be used for adjustably securing a strap  37  to a ventilation-aid securement device  36 , such as buckles or hook-and-latch systems. 
     Referring now to  FIG. 1 , the ventilation-aid securement device  36  also includes a securement housing  41  that is generally oval-shaped and approximately centered atop the face plate  40 . The securement housing  41  is formed integral with an upper surface of the face plate  40  and is used for receiving and securing a ventilating device  14 ,  22  (see  FIGS. 2 ,  5 , and  6 ). Although the securement housing  41  can receive and secure both the endotracheal tube  14  (see  FIGS. 5 and 6 ) and the mask  22  (see  FIG. 2 ), the securement housing  41  is used to secure only one ventilating device  14 ,  22  at a time. 
     Continuing with  FIG. 1 , the securement housing  41  includes a continuous wall  47  that defines two apertures: an oxygen-supply inlet aperture  44  and a tube aperture  46 . The oxygen-supply inlet aperture  44  is in the general shape of a cylinder and sized for closely receiving an oxygen-supply inlet  23  (see  FIG. 2 ) of the mask  22  (see  FIG. 2 ). The tube aperture  46  is in the general shape of an ovate cylinder and of smaller diameter than the oxygen-supply inlet aperture  44 . The tube aperture  46  is sized for closely receiving the endotracheal tube  14  (see  FIGS. 5 and 6 ). In addition, the ovate shape of the tube aperture  46  allows for the tube to be wedged within the tube aperture  46  to further secure it in place. The oxygen-supply inlet aperture  44  is adjacent the tube aperture  46 , with a narrow opening  45  connecting the two apertures  44 ,  46 . 
     Still referring to  FIG. 1 , the securement housing  41  further includes a thumbscrew housing  48  located adjacent the oxygen-supply inlet aperture  44  in opposition to the tube aperture  46 . The thumbscrew housing  48  has a threaded opening  49  for receiving a thumbscrew  53  therein. A threaded portion  54  of the thumbscrew  53  is of sufficient length to protrude through the thumbscrew housing  48  and into the adjacent oxygen-supply inlet aperture  44 . After the oxygen-supply inlet aperture  44  has received the oxygen-supply inlet  23  of the mask  22 , the thumbscrew  53  is advanced to make contact with the oxygen-supply inlet  23  to secure the mask  22  in place. 
     Referring now to  FIG. 3 , the emergency ventilation system  10  includes an angled laryngoscope handle  32 . A base of a laryngoscope blade  28  is secured in an upper portion  33  of the handle  32 , the handle  32  and blade  28  comprising a laryngoscope  26 . The laryngoscope  26  is used to peer into the larynx of the patient  60  to aid in intubating. In the present embodiment, the laryngoscope handle  32  is envisioned to be made of metal. In alternate embodiments, however, other durable materials might be used to construct a laryngoscope handle  32 . 
     Continuing with  FIG. 3 , a lower portion  34  of the laryngoscope handle  32  is elongated and substantially cylindrical with a cavity (not shown) for carrying batteries (not shown) to power a light  29  on the blade  28 . A coupling (not shown) used to detachably fix the blade  28  to the upper portion  33  of the handle  32  also provides for transmitting power from the batteries to the light  29 . Note that in alternate embodiments other methods might be used to power the light on the laryngoscope blade  28 . 
     Still referring to  FIG. 3 , the blade  28  is secured to the upper portion  33  of the handle  32  such that a longitudinal axis extending along the base of the blade  28  intersects a longitudinal axis of the lower portion  34  of the handle  32  at an angle between approximately twenty and forty degrees. At this angle, the handle  32  permits the caregiver a better view of the mouth  61  and trachea of the patient  60  than laryngoscope handles that secure their blades at a substantially perpendicular angle. In addition, this angle provides the caregiver a good angle of leverage for lifting the jaw of the patient  60 . Note that in alternate embodiments a laryngoscope handle  32  might be configured differently to achieve an angle of approximately twenty to forty degrees between blade  28  and handle  32 . 
     Referring now to  FIGS. 5 and 6 , after the laryngoscope handle  32  (see  FIG. 3 ) and attached blade  28  (see  FIG. 3 ) have been used to help the caregiver intubate the patient  60  with the endotracheal tube  14 , the ventilation-aid securement device  36  is lowered over an end of the tube  14 . The tube aperture  46  of the securement housing  41  receives the end of the endotracheal tube  14 . The tube  14  is now in position to be secured in place using a retaining arm  51 . 
     Referring now to  FIGS. 4-6 , the retaining arm  51  is used to contact and secure in place the endotracheal tube  14  (see  FIGS. 5 and 6 ). The retaining arm  51  includes an elongated extension portion  57  and a flange  52  (see  FIGS. 5 and 6 ). A first end  58  of the extension portion  57  is formed integral with an end of the flange  52 , and the flange  52  extends generally perpendicular to the extension portion  57 . The flange  52  includes a hole  59  (see  FIG. 5 ) for receiving the thumbscrew  53 . To attach the retaining arm  51  to the ventilation-aid securement device  36 , the thumbscrew  53  is inserted through the hole  59  in the flange  52  such that the extension portion  57  extends over the threaded portion  54  of the thumbscrew  53  in a direction opposite a head  55  of the thumbscrew  53 . The thumbscrew  53  is then screwed into the threaded opening  49  (see  FIG. 5 ) of the thumbscrew housing  48  such that the extension portion  57  extends over the oxygen-supply inlet aperture  44  of the securement housing  41 . Tightening the thumbscrew  53  advances a second opposing end  58  of the extension portion  57  through the narrow opening  45  (see  FIG. 4 ) connecting the oxygen-supply inlet  44  and the tube aperture  46  to contact the endotracheal tube  14 . As the second end  58  pushes against the tube  14 , the tube  14  is driven against an inside surface of the wall  47  of the securement housing  41 . Due to the ovate shape of the tube aperture  46 , the tube  14  becomes wedged, thereby further securing the tube  14  in place. An upper surface of the thumbscrew housing  48  contains a recess  50  (see  FIG. 1 ) aligned with the retaining arm  51  to ensure passage of the retaining arm  51  through this portion of the thumbscrew housing  48 . 
       FIGS. 7-9  depict a second preferred embodiment of a ventilation-aid securement device  136 , in accordance with the present invention. In the present embodiment, the ventilation-aid securement device  136  is configured to secure a mask  22  (see  FIG. 9 ) to a patient  60  (see  FIG. 9 ) using a different configuration than in the first embodiment  36 . 
     Referring now to  FIGS. 7-9 , the ventilation-aid securement device  136  includes an elongated face plate  140  that is generally rectangular and approximately one-half inch thick. The face plate  140  is flexible so as to conform to a curved surface, such as a surface of a ventilating mask  22  (see  FIG. 9 ). The face plate  140  has opposing side portions  143 , each containing a strap opening  142  for receiving an end portion  138  (see  FIG. 9 ) of a strap  137 . 
     Continuing with  FIGS. 7-9 , the securement device  136  also includes the adjustable strap  137 . The strap  137  is placed around the head of the patient  60  and adjustably attached to the securement device  136 . A first end portion  138  of the strap  137  is attached to a first strap opening  142  of the face plate  140 . A second opposing unattached end portion (not shown) of the strap  137  is equipped with Velcro® permitting the second end portion to be passed through a second strap opening  142  and adjustably secured there. Note that in alternate embodiments, other fastening modes might be used for adjustably securing a strap  137  to a ventilation-aid securement device  136 , such as buckles or hook-and-latch systems. 
     While the invention has been described with respect to certain specific embodiments, it will be appreciated that many modifications and changes may be made by those skilled in the art without departing from the spirit of the invention. It is intended, therefore, that the appended claims cover all such modifications and changes as fall within the true spirit and scope of the invention.