Patent Publication Number: US-2005133038-A1

Title: Adjustable collar and retainer for endotracheal tube

Description:
BACKGROUND OF THE INVENTION  
      This invention relates to an adjustable collar for a nasal or oral endotracheal tube, and a retainer comprising the collar useful for securing the nasal or oral endotracheal tube in a patient. More particularly, the endotracheal tube retainer comprises the adjustable collar and lateral extensions from the collar useful for securing the collar to the head of the patient. The retainer optionally further comprises at least one strap attached to the lateral extensions for securing the collar to the head of the patient.  
      During intubation, an endotracheal tube is inserted into the patient&#39;s trachea through the nasal or oral cavity. Patients in intensive care units frequently require prolonged intubation. Prolonged intubation, whether nasally or orally, may have associated endotracheal tube related consequences. The most important of these is inadvertent extubation or alteration of tube position. Additional problems may be seen with pressure ulceration of the nostril or skin reactions where the endotracheal tube is secured to the patient&#39;s skin. Traditionally, endotracheal tubes have been held in position with tape or cloth ties. These are prone to the collection of secretions (with associated infection), are difficult to change, and tend to loose their ability to secure the tube with time. They are also problematic for adult males with facial hair.  
      U.S. Pat. No. 5,934,276, Fabro, et al., discloses an endotracheal oral tube holder containing a face anchor and a tube cradle. The face anchor has buckles that hold a head harness. U.S. Pat. No. 5,076,269, Austin, discloses an endotracheal tube retaining apparatus that includes a soft, flexible plate for engaging against the patient&#39;s upper lip, with a ring fastener for connecting the soft plate to the endotracheal tube. U.S. Pat. No. 6,408,850, Sudge, discloses a medical tube holder that fastens around a medical tube through interlocking ends, and means for attaching a harness assembly.  
      Despite these and other devices known in the art, there is a continuing need for a device that can securely retain an endotracheal tube in position for a period of time, is hygienic and protective of surrounding tissues, and can easily be adjusted or removed.  
     BRIEF DESCRIPTION OF THE INVENTION  
      The present invention relates to an adjustable collar for a nasal or oral endotracheal tube, said collar comprising: 
          a) a smooth first surface for contacting the skin of a patient using the endotracheal tube,     b) a support section attached to the first surface, and     c) a band attached to the support section comprising flexible domes that compress against the tube and grip it when the collar is secured around the tube.        

      The invention also relates to a retainer for securing a nasal or oral endotracheal tube in a patient, said retainer comprising: 
          a) an adjustable collar comprising: 
            (i) a smooth first surface for contacting the skin of the patient,     (ii) a support section attached to the first surface, and     (iii) a band attached to the support section comprising flexible domes that compress against the tube and grip it when the collar is secured around the tube, and    
            b) lateral extensions from the collar for securing the collar to the head of the patient.        

      In another aspect, the invention relates to a retainer as described above further comprising at least one strap attached to the lateral extensions for securing the collar to the head of the patient. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a frontal view of an endotracheal tube retainer of the invention securing a nasal endotracheal tube in a patient.  
       FIG. 2  is a side view of the retainer of  FIG. 1  secured to the head of the patient, with the nasal endotracheal tube held in place.  
       FIG. 3  is an enlarged partial side view of the adjustable collar component of the retainer of  FIG. 1 , with the collar being closed around the nasal endotracheal tube and securing it in position.  
       FIG. 4  is a plan view of a retainer of the invention, with the adjustable collar being in the open or non-engaged position.  
       FIG. 5  is an enlarged view of the adjustable collar of  FIG. 4 , with the collar being in a partially closed position around the endotracheal tube.  
       FIG. 6  is an enlarged view of the adjustable collar of  FIG. 4 , with the collar being in a closed position around the endotracheal tube.  
       FIG. 7  is a frontal view of an endotracheal tube retainer of the invention securing an oral endotracheal tube in a patient.  
       FIG. 8  is an enlarged view of the adjustable collar component of the retainer of  FIG. 7 , with the collar being in the open or non-engaged position.  
       FIG. 9  is an enlarged view of the adjustable collar component of  FIG. 8 , with the collar being in a partially closed position around the endotracheal tube. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      The present invention relates to an adjustable collar for a nasal or oral endotracheal tube. The adjustable collar comprises a) a smooth first surface for contacting the skin of a patient using the endotracheal tube, b) a support section attached to the first surface, and c) a band attached to the support section comprising flexible domes that compress against the tube and grip it when the collar is secured around the tube. The invention also relates to a retainer for securing a nasal or oral endotracheal tube in a patient, the retainer comprising the above adjustable collar and lateral extensions from the collar for securing the collar to the head of the patient. The retainer typically further comprises at least one strap attached to the lateral extensions for securing the collar to the head of the patient.  
      In the embodiment shown in  FIG. 1 , patient  5  is intubated with an endotracheal tube  10  secured in the nasal cavity by endotracheal tube retainer  12 . Retainer  12  comprises an adjustable collar  14  that surrounds and grips tube  10  and holds it in place in the patient&#39;s nasal cavity.  
      Adjustable collar  14  is made of a flexible, non-irritating plastic material that is ergonomically configured to comfortably fit the patient&#39;s face during use. Collar  14  is designed to have sufficient strength and stability to hold endotracheal tube  10  in place during use, including when equipment such as a ventilator or monitor is attached to the distal end of the tube. When used with a nasal endotracheal tube, collar  14  conforms to the shape and size of the patient&#39;s face in the area beneath the nose and above the upper lip of the patient. The collar is also designed to flex with movement in the contact area of the patient&#39;s skin. The collar retains its shape during use, but has sufficient “give” to relieve pressure on the patient&#39;s face. The width of the collar is selected to dissipate the pressure that occurs when it is secured to the patient&#39;s face, thus preventing pressure sores. Collar  14  is typically made of silicone, polypropylene, polyethylene, polyvinylchloride, or similar material. In one embodiment, the collar is made of silicone, available as Dow Coming Silastic, medical grade.  
      Endotracheal tube retainer  12  also comprises lateral extensions  16  from adjustable collar  14  for securing the collar to the head of the patient. Lateral extensions  16  typically lie against the skin of the face, and thus have a smooth surface with no sharp edges that contact the skin. These lateral extensions are made of a flexible, non-irritating plastic material, often the same material used to form the adjustable collar  14 . The lateral extension  16  and collar  14  are typically formed as one unit, although the collar can be a separate component that is attached to the lateral extensions, for example by snapping, clipping or hooking it in place.  
      Lateral extensions  16  may extend around the back of the patient&#39;s head and/or neck and secure adjustable collar  14  to the head of the patient. Typically however, retainer  12  further comprises at least one strap  18  attached to the lateral extensions that is used to secure the collar to the patient&#39;s head. In the embodiment shown in  FIGS. 1 and 2 , lateral extensions  16  have a bi-lobed or Y-shaped appearance to allow for attachment of two straps through eyelets  20 . Various means may be used to attach the one or more straps to the lateral extensions, including hook and loop mechanical fasteners, snaps, buckles, buttons, ties, and the like.  
      In the embodiment shown in  FIGS. 1 and 2 , a lower strap  18  loops around the neck below the ears and an upper strap  18  loops around the head above the ears. In one embodiment, the straps comprise a hook and loop refastentable material, such as the VELCRO brand material, to allow for easy length alteration (as seen with tracheotomy ties). Such straps should lie laterally against the scalp skin so as not to damage the skin. As shown in  FIG. 2 , the straps can be connected to each other by at least one additional strap, e.g., two straps that attach vertically behind each ear. This minimizes the risk of the straps coming loose (e.g., to prevent the superior strap flipping up over the head).  
      In another embodiment, the lateral extensions are attached to a head harness comprising straps made of cloth, elastic plastic or rubber material adapted to fit the head of the patient and hold the retainer in place with little pressure on the face. The straps may go through self-locking buckles so that the device has multiple adjustable points. The straps typically have an upward pull so as to keep the device from slipping on the face.  
      In the embodiment shown in  FIG. 3 , adjustable collar  14  comprises a smooth first surface  22  that contacts the patient&#39;s skin, in this case, in the region between the nose and the mouth. First surface  22  may be an element of a separate collar, such as shown in  FIG. 3 , or an element of a one-piece retainer comprising the collar and lateral extensions, such as shown in  FIGS. 1-2 . Alternatively, the collar may have a first surface that attaches to lateral extensions that directly contact the patient&#39;s skin. In either case, the first surface  22  should be smooth with no sharp angles where it contacts the skin, directly or indirectly. The first surface is made of a flexible plastic material that is non-irritating to the patient&#39;s skin, such as silicone, polypropylene or other conformable plastic that generally contours to the shape of the patient&#39;s face and has the ability to yield slightly to relieve any pressure on the face.  
      As shown in  FIG. 3 , adjustable collar  14  typically tapers in the region where it contacts tube  10  to allow for increased lateral movement of the edges of the collar and tube during use. This minimizes the risk of the tube kinking where it exits collar  14 , and minimizes the risk of damage to the patient&#39;s skin through rubbing along first surface  22 . When used with a nasal endotracheal tube, the adjustable collar typically holds the tube at an angle of from about 40° to about 70°, more typically from about 50° to about 60°, relative to the skin between the patient&#39;s nose and upper lip, whereby the tube is closer to the skin proximally than distally. This is shown as the angle alpha in  FIG. 3 . Such a configuration helps to protect the nostril skin while minimizing the bend on the tube as it exits the nostril. The angle alpha will vary dependent on the age of the patient and the diameter of the endotracheal tube.  
      Adjustable collar  14  further comprises a support section  25  that is connected to first surface  22 . Support section  25  supports endotracheal tube  10  and helps hold it in place at the desired distance and angle relative to the patient&#39;s face. Support section  25  is located between first surface  22  and that portion of the adjustable collar that grips the endotrachael tube when the collar is secured around the tube. Support section  25  typically is connected to, e.g., it sits on top of or adjacent to, a second surface  24  of adjustable collar  14 . Second surface  24  is generally parallel to first surface  22 , and typically is the surface opposite first surface  22 .  
      In the embodiment shown in  FIG. 4 , adjustable collar  14  of retainer  12  is shown in an open or non-engaged position. When attaching the collar to endotracheal tube  10 , the collar initially lies flat and the tube is placed on it. Adjustable collar  14  comprises a smooth first surface  22  for contacting the skin of the patient, and a second surface  24 , generally parallel to first surface  22 . Support section  25  is attached to first surface  22  and second surface  24 , e.g., it sits on top of second surface  24  and first surface  22  when adjustable collar  14  is viewed as shown in  FIGS. 4-6 .  
      Adjustable collar  14  further comprises a band  27  attached to support section  25  that comprises flexible domes  26  e.g., silicone domes, that compress against and grip endotracheal tube  10  when the collar is secured around the tube. The flexible domes have a high friction coefficient where they contact the tube to hold the tube in place in the patient. The domes may be in the form of dimples that have a circular base, or laterally extending ridges that have a domed surface which contacts the tube, as shown in  FIG. 4 . The domes typically have a height above the surface of from about 0.3 to about 3 mm, more typically from about 0.5 to about 2 mm. The domes may also have a flat or flattened top prior to contacting the tube. The domes are typically distributed substantially uniformly along the length of band  27  where they contact tube  10  when adjustable collar  14  is secured around the tube, but any distribution that allows the adjustable collar to grip the tube may be used.  
      As shown in  FIG. 4 , band  27  typically also comprises a high strength strip of plastic, such as retainer strip  28 , which typically underlies the domes. One end of the retainer strip  28  has a lock, such as ratcheted lock  30 , while the other end has a belt, such as tapered belt  32 . As shown in  FIG. 5 , belt  32  can be passed around endotracheal tube  10  and through lock  30 . Retainer strip  28  is then partially tightened around tube  10  so that at least some of domes  26  contact the tube. The tube is held in place, but there is still sufficient space for some adjustment of the tube position. Once the desired tube position is achieved, belt  32  is pulled tight to secure collar  14  around tube  10 , as shown in  FIG. 6 . In this position, domes  26  will be pulled tight against tube  10 , without significantly compressing it and restricting air flow. The protruding end of belt  32  is typically cut off. A small gap between lock  30  and tube  10  allows one to easily cut retainer strip  28  and open adjustable collar  14  when tube  10  is no longer needed or the collar needs to be replaced. Other means may be used to secure the collar around the tube, such as the harness tie disclosed in U.S. Pat. No. 5,076,269 or the clamp and wrap around strap disclosed in U.S. Pat. No. 4,516,293. Alternatively, the ends of the collar may comprise snaps, buckles, or ties that can be used to secure the collar around the tube.  
      While the above embodiments have been described in the context of a retainer for a nasal endotracheal tube, the present invention also relates to a retainer for an oral endotracheal tube, and an adjustable collar for use therein.  
      In the embodiment shown in  FIG. 7 , patient  35  is intubated with an endotracheal tube  40  secured in the oral cavity by endotracheal tube retainer  42 . Retainer  42  comprises an adjustable collar  44  that surrounds and grips tube  40  and holds it in place in the patient&#39;s oral cavity.  
      Adjustable collar  44  is made of a flexible, non-irritating plastic material that is ergonomically configured to comfortably fit the patient&#39;s face during use. Collar  44  is designed to have sufficient strength and stability to hold endotracheal tube  40  in place during use, including when equipment such as a ventilator or monitor is attached to the distal end of the tube. Collar  44  is also designed to flex with movement in the contact area of the patient&#39;s skin, including the lips. The collar retains its shape during use, but has sufficient “give” to relieve pressure on the patient&#39;s face. The width of the collar is selected to dissipate the pressure that occurs when it is secured to the patient&#39;s mouth, thus preventing pressure sores. Collar  44  is typically made of silicone, polypropylene, polyethylene, polyvinylchloride, or similar material. In one embodiment, the collar is made of silicone, available as Dow Coming Silastic, medical grade.  
      Endotracheal tube retainer  42  also comprises lateral extensions  46  from adjustable collar  44  for securing the collar to the head of the patient. Lateral extensions  46  typically lie against the skin of the face, and thus have a smooth surface with no sharp edges that contact the skin. These lateral extensions are made of a flexible, non-irritating plastic material, often the same material used to form the adjustable collar  44 . The lateral extension  46  and collar  44  are typically formed as one unit, although the collar can be a separate component that is attached to the lateral extensions, for example by snapping, clipping or hooking it in place.  
      Lateral extensions  46  may extend around the back of the patient&#39;s head and/or neck and secure adjustable collar  44  to the head of the patient. Typically however, retainer  42  further comprises at least one strap  48  attached to the lateral extensions that is used to secure the collar to the patient&#39;s head. In the embodiment shown in  FIG. 7 , lateral extensions  46  have a bi-lobed or Y-shaped appearance to allow for attachment of two straps through eyelets  50 . Various means may be used to attach the one or more straps to the lateral extensions, including hook and loop mechanical fasteners, snaps, buckles, buttons, ties, and the like.  
      In the embodiment shown in  FIG. 7 , a lower strap  48  loops around the neck below the ears and an upper strap  48  loops around the head above the ears. In one embodiment, the straps comprise a hook and loop refastentable material, such as the VELCRO brand material, to allow for easy length alteration (as seen with tracheotomy ties). Such straps should lie laterally against the scalp skin so as not to damage the skin. The straps can be connected to each other by at least one additional strap, e.g., two straps that attach vertically behind each ear. This minimizes the risk of the straps coming loose (e.g., to prevent the superior strap flipping up over the head).  
      In another embodiment, the lateral extensions are attached to a head harness comprising straps made of cloth, elastic plastic or rubber material adapted to fit the head of the patient and hold the retainer in place with little pressure on the face. The straps may go through self-locking buckles so that the device has multiple adjustable points. The straps typically have an upward pull so as to keep the device from slipping on the face.  
      In the embodiment shown in  FIG. 8 , adjustable collar  44  comprises a smooth first surface  52  that contacts the patient&#39;s lips or surrounding skin. First surface  52  may be an element of a separate collar, or an element of a one-piece retainer comprising the collar and lateral extensions, such as shown in  FIG. 7 . Alternatively, the collar may have a first surface that attaches to lateral extensions that directly contact the patient&#39;s skin. In either case, the first surface should be smooth with no sharp angles where it contacts the skin, directly or indirectly. The first surface is made of a flexible plastic material that is non-irritating to the patient&#39;s skin, such as silicone, polypropylene or other conformable plastic that generally contours to the shape of the patient&#39;s face and has the ability to yield slightly to relieve any pressure on the face.  
      Adjustable collar  44  further comprises a support section  55  that is connected to first surface  52 . Support section  55  supports endotracheal tube  40  and helps hold it in place at the desired distance and angle relative to the patient&#39;s face. Support section  55  is located between first surface  52  and that portion of the adjustable collar that grips the endotrachael tube when the collar is secured around the tube. Support section  55  typically is connected to, e.g., it sits on top of or adjacent to, a second surface  54  of adjustable collar  44 . Second surface  54  is generally parallel to first surface  52 , and typically is the surface opposite first surface  52 .  
      In the embodiment shown in  FIG. 8 , adjustable collar  44  is shown in an open or non-engaged position. When attaching the collar to the endotracheal tube, the collar initially lies flat and the tube is placed on it though an open section, such as cradle  53 , in the top portion of the collar. Adjustable collar  44  comprises a smooth first surface  52  for contacting the skin of the patient, and a second surface  54 , generally parallel to first surface  52 . Support section  55  is attached to first surface  52  and second surface  54 , e.g., it sits adjacent to second surface  54  and first surface  52  when adjustable collar  44  is viewed as shown in  FIGS. 8-9 .  
      Adjustable collar  44  also comprises band  57  attached to support section  55  comprising flexible domes  56 , e.g., silicone domes, that compress against endotrachael tube  40  and grip it once the collar is secured around the tube. The flexible domes have a high friction coefficient where they contact the tube to hold the tube in place in the patient. The domes may be in the form of dimples that have a circular base, or laterally extending ridges having a domed surface which contacts the tube, as shown in  FIG. 8 . The domes typically have a height above the surface of from about 0.3 to about 3 mm, more typically from about 0.5 to about 2 mm. The domes may also have a flat or flattened top prior to contacting the tube. The domes are typically distributed substantially uniformly along the length of band  57  where they contact tube  40  when adjustable collar  44  is secured around the tube, but any distribution that allows the adjustable collar to grip the tube may be used.  
      As shown in  FIGS. 8 and 9 , band  57  typically also comprises a high strength strip of plastic, such as retainer strip  58 , which typically underlies the domes. One end of the retainer strip  58  has a lock, such as ratcheted lock  60 , while the other end has a belt, such as tapered belt  62 . Belt  62  can be passed around endotracheal tube  40  and through lock  60 . Retainer strip  58  is then partially tightened around tube  40  so that at least some of domes  56  contact the tube. The tube is held in place, but there is still sufficient space for some adjustment of the tube position. Once the desired tube position is achieved, belt  62  is pulled tight to secure collar  44  around tube  40 . In this position, domes  56  will be pulled tight against tube  40 , without significantly compressing it and restricting air flow. The protruding end of belt  62  is typically cut off. A small gap between lock  60  and tube  40  allows one to easily cut retainer strip  58  and open adjustable collar  44  when tube  40  is no longer needed or the collar needs to be replaced. Other means may be used to secure the collar around the tube, such as the harness tie disclosed in U.S. Pat. No. 5,076,269 or the clamp and wrap around strap disclosed in U.S. Pat. No. 4,516,293. Alternatively, the ends of the collar may comprise snaps, buckles, or ties that can be used to secure the collar around the tube.  
      The endotracheal tube retainer herein may vary in style and size, depending on the needs of the patient. For example, the retainer may be sized for various endotracheal tubes, which typically have an outside diameter ranging from 2.0 mm through 10.0 mm, in 0.5 mm increments.  
      Although various embodiments of the invention have been described and exemplified, it will be understood that the scope of the invention is not limited to that description. Changes and modifications will occur to those of ordinary skill in the art and they can be made without departing from the spirit and scope of the invention. The invention is considered to include the methods of accomplishing the results described herein as well as structures designed to accomplish them.  
      As used herein, the term “comprising” means various components, capabilities and/or steps can be conjointly employed in the present invention. Accordingly, the term “comprising” encompasses the more restrictive terms “consisting essentially of” and “consisting of”.