Abstract:
An intubation tube oral appliance system for providing a semi-customized support for an intubation tube that protects the intubation tube and facilitates the delivery of oral hygiene materials to reduce the incidences of ventilator associated pneumonia (VAP). The intubation tube oral appliance system generally includes a tube support, a first tray extending from the tube support and a second tray extending from the tube support. The tube support is formed to receive an intubation tube and a strap secures the intubation tube to the tube support. The first tray and the second tray include a thermoplastic layer that is formed to the ventilation patient&#39;s teeth. An antibacterial solution and/or fluoride solution is placed within the first tray and second tray prior to insertion into the ventilation patient&#39;s mouth to reduce dental plaque and VAP.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not applicable to this application. 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable to this application. 
       BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    The present invention relates generally to an intubation tube support devices and more specifically it relates to an intubation tube oral appliance system for providing a semi-customized support for an intubation tube that protects the intubation tube and facilitates the delivery of oral hygiene materials to reduce the incidences of ventilator associated pneumonia (VAP). 
         [0005]    2. Description of the Related Art 
         [0006]    Any discussion of the related art throughout the specification should in no way be considered as an admission that such related art is widely known or forms part of common general knowledge in the field. 
         [0007]    Ventilator associated pneumonia (VAP) is an infection of the airways commonly associated with ventilator use. Unfortunately, VAP is a significant cause of death involving hospital acquired infections. Dental plaque develops in ventilated patients because of the lack of mechanical chewing and the absence of saliva. The dental plaque is colonized by respiratory pathogens in ventilated patients resulting in VAP. Daily oral care for a ventilated patient is important to prevent VAP by reducing the dental plaque that builds up. The current protocol in hospitals is to have a plurality of toothbrushes color coded for the time of day when the brushing should occur (typically once every two hours). Unfortunately, it is difficult and labor intensive to brush the teeth of a ventilation patient. Another problem with conventional oral care for ventilation patients is the increased possibility of tube disruption because of the periodic cleanings. 
         [0008]    Because of the inherent problems with the related art, there is a need for a new and improved intubation tube oral appliance system for providing a semi-customized support for an intubation tube that protects the intubation tube and facilitates the delivery of oral hygiene materials to reduce the incidences of ventilator associated pneumonia (VAP). 
       BRIEF SUMMARY OF THE INVENTION 
       [0009]    The invention generally relates to an intubation tube support devices which includes a tube support, a first tray extending from the tube support and a second tray extending from the tube support. The tube support is formed to receive an intubation tube and a strap secures the intubation tube to the tube support. The first tray and the second tray include a thermoplastic layer that is formed to the ventilation patient&#39;s teeth. An antibacterial solution and/or fluoride solution is placed within the first tray and second tray prior to insertion into the ventilation patient&#39;s mouth to reduce dental plaque and VAP. 
         [0010]    There has thus been outlined, rather broadly, some of the features of the invention in order that the detailed description thereof may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional features of the invention that will be described hereinafter and that will form the subject matter of the claims appended hereto. In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction or to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of the description and should not be regarded as limiting. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    Various other objects, features and attendant advantages of the present invention will become fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views, and wherein: 
           [0012]      FIG. 1  is an upper perspective view of the present invention. 
           [0013]      FIG. 2  is an upper perspective view of the present invention with an intubation tube attached within the present invention. 
           [0014]      FIG. 3  is a front end view of the present invention. 
           [0015]      FIG. 4  is a rear end view of the present invention. 
           [0016]      FIG. 5  is a top view of the present invention. 
           [0017]      FIG. 6  is a bottom view of the present invention. 
           [0018]      FIG. 7  is a left side view of the present invention. 
           [0019]      FIG. 8  is a cross sectional view taken along line  8 - 8  of  FIG. 2 . 
           [0020]      FIG. 9  is an upper perspective view of the present invention positioned within the mouth of a patient. 
           [0021]      FIG. 10  is an upper perspective view of an alternative embodiment of the present invention utilizing a head strap. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A. Overview 
       [0022]    Turning now descriptively to the drawings, in which similar reference characters denote similar elements throughout the several views,  FIGS. 1 through 10  illustrate an intubation tube oral appliance system  10 , which comprises a tube support  20 , a first tray  40  extending from the tube support  20  and a second tray  50  extending from the tube support  20 . The tube support  20  is formed to receive an intubation tube  12  and a strap  14  secures the intubation tube  12  to the tube support  20 . The first tray  40  and the second tray  50  include a thermoplastic layer that is formed to the ventilation patient&#39;s teeth. An antibacterial solution and/or fluoride solution is placed within the first tray  40  and second tray  50  prior to insertion into the ventilation patient&#39;s mouth to reduce dental plaque and VAP. The tube support  20 , first tray  40  and the second tray  50  are preferably comprised of a unitary, hard material such as but not limited to acrylic. 
       B. Tube Support 
       [0023]      FIGS. 1 and 5  best illustrate the tube support  20  that forms a center channel  24  to receive a portion of an intubation tube  12  inserted into a ventilation patient. The tube support  20  is comprised of an elongated structure and is preferably straight as best illustrated in  FIGS. 5 and 7  of the drawings. 
         [0024]    The tube support  20  includes an outer end  22  that extends outwardly from the ventilation patient&#39;s mouth. The tube support  20  further is preferably comprised of a first tube wall  26  and a second tube wall  28  that are substantially mirrors of one another as illustrated in  FIGS. 1 and 3  of the drawings. The center channel  24  faces upwardly thereby allowing the intubation tube  12  to be positioned within and supported by the tube support  20 . 
         [0025]    The tube support  20  further preferably has a U-shaped cross sectional shape forming the center channel  24  that receives a lower portion of the intubation tube  12  as illustrated in  FIGS. 2 and 8  of the drawings. The center channel  24  has a width sufficient to receive the intubation tube  12  and preferably has a width approximately equal to the outer diameter of the intubation tube  12  to ensure a relatively secure fit of the intubation tube  12  within the center channel  24  as illustrated in  FIG. 8  of the drawings. 
       C. Trays 
       [0026]    The first tray  40  extends from the tube support  20  at a first angle and the second tray  50  extends from the tube support  20  opposite of the first tray  40  at a second angle as illustrated in  FIGS. 1 through 6  of the drawings. As best illustrated in  FIG. 5  of the drawings, the first tray  40  and the second tray  50  preferably extend away from one another and are angled so that the first tray  40  is adapted to receive the right upper teeth of a ventilation patient and the second tray  50  is adapted to receive the left upper teeth of the ventilation patient. The first tray  40  and the second tray  50  are preferably approximately 45 mm apart from one another between their respect first end  42  and second end  52 . The first tray  40  and the second tray  50  preferably substantially mirror one another as best illustrated in  FIG. 5  of the drawings. 
         [0027]    The first tray  40  includes a first channel  44  and the second tray  50  includes a second channel  54 , wherein the first channel  44  and the second channel  54  are preferably connected to the center channel  24  of the tube support  20  to form a substantially Y-shaped channel structure as illustrated in  FIG. 5  of the drawings. The first channel  44  and the second channel  54  further preferably form a substantially U-shaped channel that receives the upper teeth of the ventilation patient. 
         [0028]    The first tray  40  includes a first channel  44  defined by an inner first wall  46 , an outer first wall  48 , and a first end  42  that is substantially open wherein the first end  42  is opposite of the tube support  20  as illustrated in  FIG. 5  of the drawings. The outer first wall  48  is preferably substantially perpendicular with respect to a floor of the first channel  44  as best illustrated in  FIG. 4  of the drawings. The inner first wall  46  is preferably angled at approximately 20 degrees from the floor of the first channel  44 . The floor of the first channel  44  is preferably approximately 15 mm in width between the outer first wall  48  and the inner first wall  46 . As discussed previously, the first tray  40  is adapted to receive a plurality of right upper teeth of a patient within the first channel  44 . 
         [0029]    The first tray  40  preferably includes a first thermoplastic layer  60  within the first channel  44 . The first thermoplastic layer  60  becomes malleable when heated (e.g. by hot water) thereby allowing forming to the teeth of the ventilation patient prior to usage. After the first thermoplastic layer  60  cools to a certain temperature, the first thermoplastic layer  60  is no longer substantially malleable and is capable of receiving the teeth of the ventilation patient in a substantially snug manner. The imprints of the teeth formed into the first thermoplastic layer  60  also are adapted to receive an antibacterial solution and/or fluoride solution to assist in the dental care of the ventilation patient without having to periodically brush the teeth of the ventilation patient every two hours. 
         [0030]    The first tray  40  further preferably includes a first flange  49  extending upwardly from a forward portion of the first tray  40 . The first flange  49  is preferably slightly curved and is partially angled forwardly to comfortably remain outside of the mouth of the ventilation patient during usage as illustrated in  FIG. 9  of the drawings. The first flange  49  preferably is approximately 20 mm in height and approximately 6 mm in width to adequately protect the upper lip during usage. 
         [0031]    The first tray  40  further preferably includes a first spacer  41  extending downwardly from a lower surface of the first tray  40  as illustrated in  FIGS. 1 through 4 ,  6  and  8  of the drawings. The first spacer  41  is preferably comprised of a rounded structure as best illustrated in  FIGS. 4 and 6  of the drawings. The first spacer  41  provides spacing between the present invention and a conventional lower thermoplastic stock tray positioned upon the lower teeth of the ventilation patient. The first spacer  41  acts as a bite splint for the ventilation patient to bite upon and not damage the intubation tube  12 . 
         [0032]    The second tray  50  includes a second channel  54  defined by an inner second wall  56 , an outer second wall  58 , and a second end  52  that is substantially open wherein the second end  52  is opposite of the tube support  20  as illustrated in  FIG. 5  of the drawings. The outer second wall  58  is preferably substantially perpendicular with respect to a floor of the second channel  54  as best illustrated in  FIG. 4  of the drawings. The inner second wall  56  is preferably angled at approximately 20 degrees from the floor of the second channel  54 . The floor of the second channel  54  is preferably approximately 15 mm in width between the outer second wall  58  and the inner second wall  56 . As discussed previously, the second tray  50  is adapted to receive a plurality of right upper teeth of a patient within the second channel  54 . 
         [0033]    The second tray  50  preferably includes a second thermoplastic layer  62  within the second channel  54 . The second thermoplastic layer  62  becomes malleable when heated (e.g. by hot water) thereby allowing forming to the teeth of the ventilation patient prior to usage. After the second thermoplastic layer  62  cools to a certain temperature, the second thermoplastic layer  62  is no longer substantially malleable and is capable of receiving the teeth of the ventilation patient in a substantially snug manner. The imprints of the teeth formed into the second thermoplastic layer  62  also are adapted to receive an antibacterial solution and/or fluoride solution to assist in the dental care of the ventilation patient without having to periodically brush the teeth of the ventilation patient every two hours. 
         [0034]    The second tray  50  further preferably includes a second flange  59  extending upwardly from a forward portion of the second tray  50 . The second flange  59  is preferably slightly curved and is partially angled forwardly to comfortably remain outside of the mouth of the ventilation patient during usage as illustrated in  FIG. 9  of the drawings. The second flange  59  preferably is approximately 20 mm in height and approximately 6 mm in width to adequately protect the upper lip during usage. 
         [0035]    The second tray  50  further preferably includes a second spacer  51  extending downwardly from a lower surface of the second tray  50  as illustrated in  FIGS. 1 through 4 ,  6  and  8  of the drawings. The second spacer  51  is preferably comprised of a rounded structure as best illustrated in  FIGS. 4 and 6  of the drawings. The second spacer  51  provides spacing between the present invention and a conventional lower thermoplastic stock tray positioned upon the lower teeth of the ventilation patient. The second spacer  51  acts as a bite splint for the ventilation patient to bite upon and not damage the intubation tube  12 . 
       D. Antibacterial Solution 
       [0036]    The antibacterial solution may be comprised of a liquid or a gel. The antibacterial solution may further be comprised of any substance capable of killing bacteria such as but not limited to carbamide peroxide. The antibacterial solution may be stored and delivered via a syringe or related structure. 
       E. Fluoride Solution 
       [0037]    The fluoride solution may also be comprised of a liquid or gel. The fluoride solution may be comprised of any substance capable of strengthening teeth and limiting sensitivity of the teeth. The fluoride solution may also be stored and delivered via a syringe or related structure. 
       F. Catch Member and Strap 
       [0038]      FIGS. 1 ,  2 ,  3 ,  4  and  6  best illustrate a catch member  30  extending from the tube support  20 . The catch member  30  is preferably comprised of an elongated structure that extends horizontally from either the first tube wall  26  or the second tube wall  28 . The catch member  30  further preferably includes an end portion  32  that is broader than a width of the catch member  30  to catchably retain the strap  14  upon the catch member  30  when secured as illustrated in  FIGS. 1 through 3 . The end portion  32  preferably is comprised of a bulbous structure as illustrated in  FIGS. 1 through 3 . 
         [0039]    The strap  14  is preferably comprised of an elastic material such as but not limited to rubber. The strap  14  includes a first aperture  13  and a second aperture  15  near an opposite end of the first aperture  13  as illustrated in  FIG. 1  of the drawings. The first aperture  13  is positionable upon the catch member  30  initially and then the strap  14  is wrapped around the tube support  20  and the intubation tube  12  to retain the intubation tube  12  within the center channel  24 . The second aperture  15  of the strap  14  is positioned over the catch member  30  to retain the strap  14  about the intubation tube  12  as illustrated in  FIG. 2  of the drawings. 
       G. Alternative Embodiment 
       [0040]      FIG. 10  illustrates an alternative embodiment of the present invention comprised of a second catch member  34  extending from the tube support  20  opposite of the first catch member  30 . The second catch member  34  includes a second end portion  36  similar to the first end portion  32  as shown in  FIG. 10 . The strap  14  is attached to the first catch member  30  and the second catch member  34  to retain the intubation tube  12  as illustrated in  FIG. 10  of the drawings. In addition, a head strap  70  having distal apertures at opposing ends is attached to the first catch member  30  and the second catch member  34  to secure the present invention to the head of a patient. 
       H. Operation of Preferred Embodiment 
       [0041]    In use, the first thermoplastic layer  60  and the second thermoplastic layer  62  are heated to a state where they become malleable (e.g. by placing in hot water). Once the first thermoplastic layer  60  and the second thermoplastic layer  62  are malleable, the trays  40 ,  50  are positioned upon the ventilation patient&#39;s upper teeth to be fitted to the patient&#39;s upper teeth by forming an imprint of the upper teeth in the first thermoplastic layer  60  and the second thermoplastic layer  62 . The trays  40 ,  50  are removed from the upper teeth and the first thermoplastic layer  60  and the second thermoplastic layer  62  are allowed to cool into a hardened state. The antibacterial solution is then placed on the first thermoplastic layer  60  and the second thermoplastic layer  62  prior to insertion into the mouth of the ventilation patient. The fluoride solution may be utilized after 12 hours of the antibacterial solution to rotate the solutions used. After the antibacterial solution is placed upon the first thermoplastic layer  60  and the second thermoplastic layer  62 , the trays  40 ,  50  are reinserted into the ventilation patient&#39;s mouth with the first flange  49  and the second flange  59  remaining outside of the upper lip to protect the upper lip as illustrated in  FIG. 9  of the drawings. The intubation tube  12  is then positioned within the center channel  24  of the tube support  20  and the strap  14  is then secured to retain the intubation tube  12  in a desired position. After a period of time (e.g. 12 hours), the present invention may be removed, cleaned and a replacement solution (e.g. antibacterial or fluoride) applied to the first thermoplastic layer  60  and the second thermoplastic layer  62 . It can be appreciated that a conventional basic thermoplastic stock tray may be attached to the lower teeth of the patient opposite of the present invention. 
         [0042]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar to or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described above. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety to the extent allowed by applicable law and regulations. In case of conflict, the present specification, including definitions, will control. The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof, and it is therefore desired that the present embodiment be considered in all respects as illustrative and not restrictive. Any headings utilized within the description are for convenience only and have no legal or limiting effect.