Patent Publication Number: US-11660412-B2

Title: Endotracheal tube guard with optional holding system and optional sensor

Description:
FIELD OF THE INVENTION 
     The present invention generally relates to the field of medical protective systems and protective restraints. In particular, the present invention is directed to endotracheal tube guards and related holding systems and sensors. 
     BACKGROUND 
     Despite ETT (endotracheal tube) holders which are designed to secure the ETT to the head of an intubated patient, self-extubations (removal of the ETT) are still possible, not uncommon and can have dire consequences. Patients intubated with an ETT are typically restrained by the wrists and sedated in order to prevent self-extubation, and are thus rendered unable to engage in key elements of reducing morbidity and mortality such as early mobilization in the form of autonomous in-bed activity, and sedation minimization to reduce hallucinations and cognitive decline, both of which have been shown to improve quality of life after intubation, and prevent PICS (post-intensive care syndrome), a form of PTSD (post-traumatic stress disorder). Often in a state of confusion either from illness, medication, or sleep, patients reach to remove the ETT from their mouths. Prevention of self-extubation with restraint and sedation is necessary as inopportune removal of the ETT can lead to respiratory failure and death and nurses are not always with patients to prevent this event. 
     As shown, for example, in  FIG.  1    typical features of an ETT system include external tube  10 , and internal tube  12  with a cuff  14  positioned proximally for seating in the patient&#39;s airway. ETT holder  15  may include a mouthpiece or lip protector  16  and tube clamp  18  such as locking clamp  20  to secure the ETT through and in ETT holder  15 . Other components of an ETT system may include attachment/inflation port  24  communicating with balloon cuff  14  via cuff tubing  44 , multi-port connector  26  attachable through adjustable fitment  22 , vent tube port  28  and expandable vent tube  30 , bronchoscopy port  32  and lock  34 , suction port  36  and suction catheter  38 . The ETT holder may be secured in the patient&#39;s mouth using a head strap  40 . Cheek protectors  42  prevent excessive rubbing on the patient&#39;s cheek. 
     Various types of ETT holders are employed in an attempt to secure the ETT to the patient&#39;s mouth and head. However, existing systems do not provide reliable or sufficient protection from self-extubation. Difficulties with existing systems can burden the ICU staff, who may be required to spend more time watching one patient to the detriment of another and to their documentation and medication dispersal duties. 
     SUMMARY OF THE DISCLOSURE 
     Disclosed embodiments help to hinder self-extubation of the ETT of an awake patient who may reflexively attempt removal, but also allow early mobilization and exercise necessary for preservation of as much muscle strength as possible, promotion of diaphragmatic motion necessary for liberation from the ventilator and reduction of patient stress from not being tied to the bed, allowing for sedation minimization and improved cognition. Embodiments may include an ETT holder be utilized without the ETT holder, or attached to any ETT holder currently on the market. Embodiments may also include a sensor that alarms when the ETT guard tube is pulled. 
     Disclosed embodiments may be made from conventional and readily available, medically-approved materials such as sensors, cottons, and plastics, which are transparent, latex free, MRI and other diagnostic modality-friendly, potentially disposable, lightweight, quickly and easily attachable and detachable, sturdy, and cleanable. The ETT guard tube encases the ETT, but does not touch it. The proximal end of the ETT guard tube is at the distal end of the lip protector of the ETT holder and the distal end is at the proximal portion of the multiport locking mechanism of the ventilator connector system. The ETT guard tube may have a telescoping mechanism or other longitudinal expansion mechanism within the body of the tube for length adjustability. The proximal straps are rigid and attach within the head straps of the ETT holder system. The distal straps are flexible and also attach to the head straps of the ETT holder system. The portion of the ETT guard tube distal to the rigid straps and proximal to the flexible straps is resiliently expandable or stretchable in a longitudinal direction when pulled distally and returning to its collapsed form when released. A sensor may be placed on the ETT guard tube to indicate an alarm when the tube is squeezed, extended or otherwise moved. At the proximal and distal ends of the ETT guard tube on the side that the side port of the ventilator connector system extends outward, are securement points which open and close/lock the ETT guard tube. On that side is a longitudinal opening from one securement point to the other with width measurements greater than the width of the ventilator connector system. The ETT guard tube has a greater diameter than that of the ventilator connector system and may have different diameters from proximal to distal ends. The ETT guard tube may be reconfigured to accommodate various commercially available multi-port connector systems. 
     Embodiments of the systems disclosed may include an ETT holder system to include a tube clamp with locking mechanism, mouth piece, lip protector, cheek protectors and padded head straps with hook and loop fasteners, in continuity. The ETT holder system may also include an annular connector on the mouth piece portion for direct and secure connection to the ETT guard tube, which may eliminate the need for the rigid and flexible straps between the ETT holder and ETT guard tube. 
     In one example of the disclosed embodiments, a medical staff person places the ETT guard tube around the ETT system after intubation at the lengthwise opening assuring that the ventilator port of the distal ETT system protrudes from that opening. The length of the ETT guard tube is adjusted using the telescoping mechanism. The ETT guard tube is locked in place using the securement mechanisms. 
     As may be apparent to persons of ordinary skill, the embodiment of the disclosed system allows distal pulling on the ETT guard tube without dislodgement of the ETT system which prevents the awake and so-inclined subject from dislodging the ETT system. Other advantages of the disclosed system include providing a safe level of freedom and exercise while preventing self-extubation by a confused or inattentive patient. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For the purpose of illustrating the invention, the drawings show aspects of one or more embodiments of the invention. However, it should be understood that the present invention is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein: 
         FIG.  1    is an elevation view of an ETT system including ETT, ETT holder system (proximal) and ventilator connector system (distal). 
         FIG.  2    is an elevation view of an ETT guard tube according to an embodiment of the present disclosure, placed over an ETT system as shown in  FIG.  1   . 
         FIGS.  3 A,  3 B and  3 C  are an elevation view and two end views of alternative ETT guard tubes according to embodiments disclosed herein. 
         FIG.  4   . is a side and end view of a further alternative ETT guard tube with a connection ring for connecting to a ETT holder. 
         FIGS.  5 A and  5 B  are side views illustrating connection and separation, respectively, of an ETT guard tube and ETT holder in one alternative embodiment. 
         FIG.  6    is a side view showing an alternative ETT guard tube and ETT holder in a disconnected state. 
         FIG.  7    is a photograph of the ETT guard over an ETT/ETT holder system/ventilator connector system in a side view. 
         FIGS.  8  and  9    are perspective views of a further alternative embodiment of a guard tube, wherein  FIG.  8    shows the guard in a closed position and  FIG.  9    shows the guard in an open position. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments enclosed herein offer an ETT guard with or without an ETT holder as part of a complete system, thereby allowing touching and pulling on the ETT guard without moving the ETT encased within it and may include a sensor that alarms when the device is pulled upon. Persons of ordinary skill will note that while the description of embodiments herein is made primarily with reference to ETTs, embodiments and teachings herein are equally applicable with other orally or nasally placed patient access tubes. 
     As shown in  FIG.  2   , an embodiment of an ETT guard as disclosed herein may include guard tube  50  formed as an elongate tube structure configured and dimensioned to fit over the ETT without contacting it. At the proximal end of tube  50 , a flexible portion  52  is provided. The proximal end of tube  50  above flexible portion  52  is configured for attachment to an ETT holder system, such as tube holder mouthpiece  16 . The attachment configuration of the proximal end may comprise a specially configured connector or collar, or the tube may simply terminate with a smooth edge adapted to contact mouthpiece  16 . Movement sensor  58  may be positioned also in the region of flexible portion  52  in order to detect motion of tube  50  resulting from patient touches or attempts at removal as described further below. Flexible portion  52  allows tube  50  to be moved slightly side-to-side, or pulled distally, without imparting any motion to the ETT itself. This can be critical for avoiding dislodgment of the ETT, which can happen from even very small movements depending on the patient and clinical situation. Movements of inch and potentially less can be sufficient to dislodge the ETT, leading to potentially life threatening complications. Allowing the patient to cause a small amount of motion on the tube guard also may tend to decrease the likelihood of a patient pulling or otherwise handling the tube to the point of causing problematic movement of the ETT by providing a sensation of movement of the device without actually allowing the ETT itself to move. 
     Another aspect to preventing unintended dislodgement of the ETT is the attachment to the holder and the holder system itself. In some embodiments, the proximal end of tube  50  may include attachment means for securing it to a conventional ETT tube holder mouthpiece  16 . Such attachment means may comprise appropriate attachment openings or connection points (such as rigid connection point  62   a  and flexible connection point  62   b ) in tube  50  such that rigid strap  60   a  and flexible strap  60   b  may be used to secure the tube to the holder. In such an arrangement, rigid strap  60   a  may be secured at the proximal end of tube  50  and flexible strap  60   b  secured somewhat more distally, below flexible portion  52 . In another alternative, openings along the proximal end of tube  50  may be used to secure the tube to the holder via zip ties or other commonly used attachment devices. In such a manner guard tube  50  may be utilized with a wide variety of different holder systems without the need for a specifically adapted system such as explained in more detail below. 
     Elongated openings  54  on sides of tube  50  allow for ports and attachments such as port  28  or bronchoscopy port  32  (depending on location) to extend through tube guard  50 . The elongated shape of openings  54  allows for motion of tube  50  when flexible portion  52  is extended due to patient contact with the tube. 
     In order to allow tube  50  to be installed and removed without removing the ETT, at least one parting line  70  is provided, extending along the longitudinal extent of the guard tube as shown, for example, in  FIG.  3 A . In one alternative, a single parting line  70  is provided on one side of tube  50  and longitudinal hinge  74  provided opposite, as shown in  FIG.  3 B . In this embodiment, a single connector  72  runs along parting line  70  and tube  50  opens along hinge  74 . Detent connector  72  may comprise interfering/interlocking longitudinal ridges that lock together under sufficient finger pressure and then may be removed by appropriate finger pressure adjacent the joined edges to snap the edges apart, something easily accomplished by healthcare personnel, but not by a typical, intubate patient. In some embodiments, two parting lines  70  may be provided, one on each side of the tube. When two parting lines  70  are provided, they may both be fitted with connectors such as interlocking ridges  72 , which then allow the two parted halves of tube  50  to be pushed and locked together and then parted by separating the connectors with appropriate finger pressure. Rather than being continuous along the length, both connection  72  and hinge  74  may alternately be provided as one or more shorter connectors and hinges, respectively. 
     Also shown in  FIG.  3 A  is optional nasogastric tube opening  56 . Opening  56  permits a second, smaller patient access tube such as a nasogastric tube to be placed within guard tube  50 . By locating opening  56  along parting line  70 , the guard tube may be placed or removed without removing or detaching the nasogastric tube. Also, the nasogastric tube may be later added to guard tube  50  without disturbing the ETT therein. 
     Alternative means for attaching tube  50  with the holder mouthpiece are shown, for example, in  FIGS.  4 ,  5 A,  5 B and  6   . In embodiment, attachment collar  76  is provided at the proximal end of tube  50 , proximally with respect to flexible portion  52 . Attachment collar  76  may have a notch and groove to form keyway  78 . In one alternative holder mouth piece  80 , shown in  FIGS.  5 A and  5 B , a protrusion sized to be received within the opening of attachment collar  76  is provided with extending key  82 . To connect the two parts, tube  50  and attachment collar  76  are placed over the mouthpiece and rotated to lock it in place via key  82  and keyway  78 . In another alternative embodiment, attachment collar  76   a  ( FIG.  6   ) is provided with an annular groove on the inside surface. This annular groove is sized to receive annular protrusion  84  on alternative mouthpiece  80   a  when tube  50  is opened and closed along parting line(s)  70 . 
     Sensor  58 , as shown, for example in  FIG.  2   , may take a variety of forms. It may be a motion sensor that simply detects motion of tube  50  when exceeding predetermined threshold levels or it may be a strain gauge-type sensor that detects changes in length of flexible portion  52 , also with set threshold, if desired. Sensor  58  may be connected with the patient&#39;s monitoring system and send an alarm to attending personnel when thresholds of movement or elongation are exceeded. This provides an immediate alert of any movement, which may thus prevent unintended dislodgement of the ETT. 
     A further alternative embodiment of a tube guard is shown in  FIGS.  8  and  9   . In this embodiment, tube  50  forms an elongate tube structure made in two telescoping parts  50   a  and  50   b . Both tube parts include hinges  74  and closure elements  72 . Proximal tube part  50   b  is adapted to connect with a distal collar  76   a  using an annular ring connector such as annular protrusion  84  in  FIG.  6   . Flexible portion  52  is proximally connected to distal collar  76   a  and proximal collar  76   b  connects flexible portion  52  to tube holder mouthpiece  16 . In this embodiment, flexible straps  60   a  are connected to distal collar  76   a  and rigid straps  60   b  are connected to proximal collar  76   b.    
     Distal part  50   a  of telescoping tube  50  has a large distal end to accommodate connector ports and a smaller proximal end with ridges compatible with ridges on inner, proximal tube part  50   b  in order to provide an adjustable length to accommodate different length ETTs and other intubation devices. Inner, proximal tube part  50   b  has corresponding ridges to interface with the ridges on tube part  50   a . Elongate side ports  54  are provide through both tube parts. 
     Disclosed tube guards may be used alone or in conjunction with the Protective and Exercise Hand Restraint System as described in Applicant&#39;s concurrently filed PCT Application No. PCT/US 18/64618, which is incorporated herein in its entirety, or with other currently marketed mitt restraints as a method of preventing or adding hindrance to self-extubation. In another alternative embodiment, a protective guard system for orally or nasally placed patient access tubes comprises an elongate tubular structure configured and dimensioned to surround an orally or nasally placed patient access tube with a distal end configured to engage a mouthpiece of a tube holder securing the placed tube in the patient&#39;s mouth. The elongate tubular structure has a flexible portion and a substantially rigid portion. The substantially rigid portion defines at least one longitudinally extending opening configured and dimensioned to receive a port or connector. The elongate tubular structure is further configured to be opened for lateral placement around or removal from the placed access tube without dislodging the placed access tube from its position in the patient or disconnecting the placed tube from connected devices. 
     The disclosed system provides unique features that prevent self-extubation while not strapped to a bed or chair for an awake and at-risk patient who might otherwise intentionally or unintentionally self-extubate, and encourage early mobilization and exercise promoting the strength required for advancement from the ventilator. The increased freedom provided by the disclosed system allows for reduced patient agitation and therefore sedation medication may be decreased and minimized which in turn promotes increased patient cognition and thereby would be more likely to reduce the incidence of delirium and PICS. Once the ETT guard is in place, direct nurse or sitter monitoring may not be necessary whereas the absence of restraints to tether a patient to a bed or chair without constant 1:1 supervision invites self-extubation. 
     Exemplary embodiments have been disclosed above and illustrated in the accompanying drawings. It will be understood by those skilled in the art that various changes, omissions and additions may be made to that which is specifically disclosed herein without departing from the spirit and scope of the present disclosure