"COMPLETE SPECIFICATION"
STERILE DISPOSABLE OROPHARYNGEAL AND TRACHEAL TUBE
FIXATOR
The present invention relates to providing improvement in care for the patient under Anesthesia in Operation Theater and I.C.U.(Intensive Care Unit) on support systems - Ventilator, with intubation of Oropharyngeal or Tracheal Tube.
The tube Fixator comprises of three parts cut from a Foam sheet laminated on both surfaces with soft Flannelled Nylex Fabric - a band, a Grip and a Clip. The band is sewn with loop fastener and length adjuster of peelable double sided self-adhesive tape pasted at point. The Grip is a wider band pasted end to end with peelable double side self-adhesive tape. The Clip has extensions of Velcro hooks sewn and peelable double side self-adhesive tape pasted appropriately. The tube Fixator so constructed is affixed to the intubated Oropharyngeal or Tracheal tube thereby holding it in position comfortably gripping the neck in such a manner so as to prevent displacement during nursing or otherwise reducing discomfort to the patient.
The Fixator is packed in tamperproof material with one side see through, heat sealed pouch sterilized by Gamma Irradiation and is thus infection free to the point of use.
Presently the Oropharyngeal or a Tracheal tube after intubation is held in position by passing gauze through the holes on either side of the tube plate if included, or looping it around the tube and fixed by tying it around the neck. The gauze gets soaked in normal secretions and gets infected and rumbles up like a thick rope causing graze around the neck which hurts causing discomfort.
There have been many other alternate options, for example adhesive tape pasted on the tube / tube plate if included, on both side and then being pasted on the neck skin. The adhesive tape has a tendency to irritate the skin. A similar irritation caused by pulling of the self adhesive tape off the traumatized skin has also been observed. This adds to discomfort due to straining of neck.
Normally the adhesive Zinc Oxide on the tape may pull the epidermis and cause more difficulty in treating a patient.
These methods suffer from a disadvantage of accidental displacement of the Oropharyngeal or Tracheal tube by movement (during nursing or otherwise) causing trauma and bleeding which may lead to blocking of the tube resulting in asphyxia.
The problems can be overcome by the present invention which provides a three part Fixator comprising of a Band, a Grip and a Clip made from a sheet of foam laminated on both sides with soft flannelled Nylex Fabric, sewn with Velcro loop fasteners and Velcro hook extensions and peelable double side self adhesive tape pasted at appropriate points thereof being adapted to paste the clip to Oropharyngeal or Tracheal tube and fasten the band and grip in a firm cushioned grip by surrounding around the neck respectively holding in position the intubated tube without any one part being included in the tube.
In one form of the invention the corners of the parts could be rounded , length of the Band and Clip altered with shifting position of Velcro hook and loop fasteners and the Grip given a protruding shape at the back neck with peelable double sided self-adhesive tape accordingly to suit.
In another form of the invention the materials
1. Nylex soft flannelled fabric may be replaced by another
2. Velcro hook and loop fastener in polyester may be replaced by Nylon material or another
3. Foam density and thickness may be altered to suit.
4. the lamination process of flame lamination of fabric be replaced by adhesive lamination with a combination of all above.
5. Peelable double sided self-adhesive tape could be replaced by another.
In yet another form of the invention the Clip may be discarded and on the Band the Velcro loop fasteners be replaced by Velcro hook extensions to be passed through the holes of the tube plate if included OR a comprehensive combination of all the above with no sterilization, could also be produced.
To assist understanding of the invention, reference will now be made to the accompanying drawings, which show one example of the invention.
Brief description of the Drawing:
Figure. 1 shows one example of Sterile Disposable Oropharyngeal and Tracheal Tube Fixator and in operation according to this invention.
Figure 2 to 8 show the 3 parts - A Band, a Grip and a Clip ,a cross section view according to this invention.
Detailed description of the preferred embodiments:
Referring to the drawing FIG 1 attached it can be seen that the Sterile Disposable Oropharyngeal and Tracheal Tube Fixator according to this invention comprises of three parts FIG 2 to 4 as under:
1. FIG 2 - is a Band 50 cm in length and 3 cm in width with Velcro Loop fasteners 5 and 6 facing upwards of size 50 mm length and 25 mm width sewn about 3 mm inside of end edges at point in a box fashion with reverse lock at end (FIG 8) on the two ends on surface marked 4 and on the other surface marked 8 FIG 7 point 7 - a peelable double side self-adhesive tape 5 cm in length and 3 cm in width is pasted at centre of length.
2. FIG 3 - is a Grip 50 cm in length and 5 cm in width with a peelable double side self-adhesive tape cut and pasted end to end on a surface marked 13 with the other surface as is with laminated soft Flannelled Nylex Fabric as shown.
3. FIG 4 - is a Clip 10 m in length and 3 cm in width with extensions 9 and 10 made of Velcro hook facing upwards in size 10 cm length and 1cm width and sewn 1cm in length and 1cm in width at points marked 9A and 10A in a box fashion with reverse lock ( FIG 8) at end and a peelable double side self-adhesive tape 5 cm in length and 3 cm in width pasted at centre of length point 11 on same surface as shown with the opposite surface left as is.
4. FIG 5 - cross section view - A Foam sheet marked (3) in 16 D quality ,in 2 to 3 mm thickness in the centre, Soft flannel facing outwards marked (1) of Nylex fabric marked (2) on both the surfaces of the foam laminated by flame lamination process for a firm adhesive characteristic property cut as into parts as described above.
5. FIG 6 - cross section view of Grip with a layer of peelable double side self-adhesive tape 14 pasted end to end on one surface of the foam sheet as in FIG 5 above with the opposite flannelled surface of Nylex fabric left as is.
6. FIG 8 - is sewing design in Box fashion with reverse lock at end of
stitch.
After intubation of the Oropharyngeal or Tracheal Tube, during medical procedure,
7. The Clip FIG 4 with peeled off self-adhesive tape 11 is pasted on the tube at an appropriate place (FIG1) in a firm hold and the Velcro hook extensions 9 and 10 are passed through the holes on the tube plate if included, in a loop fashion.
8. Then the band FIG 2 with Velcro loop fasteners 5 and 6 facing outwards is surrounded around the neck and extensions 9 and 10 are pressed onto these loop fasteners respectively with the soft flannelled Nylex fabric surface 8 FIG 7 touching the skin. For a firmer grip around the neck peel off the double side self-adhesive 7(FIG 7), cut at centre of length and place right side on top of the left to suite neck size thereby completing the fixation of position of the tube.
This action further grips the neck firmly and the Fixator secures the Oropharyngeal or Tracheal Tube position avoiding accidental displacement reducing discomfort of the patient.
9. To reduce discomfort further, refer to the Grip - FIG 3 surface 13 with
Peelable self adhesive tape , peel off from end to end and place it
beneath the band FIG 2 surface 8 FIG 7 and paste it surrounding the
neck (FIG 1) in such a manner that now soft flannelled Nylex fabric
surface of the Grip FIG 3 is touching the neck skin instead and foam
thickness is used as a cushion effect.
For a firm grip cut the Grip before hand at centre of length and place right side on top of the left to suite neck size thereby completing fixation of position of the tube reducing discomfort of the patient.
10. A) If for some exceptional reason the Clip (FIG 4) is replaced by
Gauze to fasten and fix position of the intubated Oropharyngeal or
Tracheal tube and tied around the neck, then band FIG 2 is to be
replaced by the Grip FIG 3 in the following manner:-
B) Peel off self adhesive surface 13 FIG 3 end to end and place it beneath the gauze with the adhesive surface folding in half at centre of width in such a manner that opposite surfaces are pasted on to itself firmly enveloping the gauze cord fixing the intubated tube position while the soft flannelled Nylex fabric surface touching the skin for soft and comfortable feel to the patient.
C) For a further firm grip cut at centre of length and place right side on top of the left to suite neck size thereby completing fixation of the tube position reducing discomfort of the patient.
11. Similarly if for some reason the intubated Oropharyngeal or Tracheal tube is held by Clip in FIG 4 as per procedure 7 above and band FIG 2 being used as in procedure 8 above is replaced by the Grip FIG 3.
Then the extensions 9 and 10 (FIG 4) need to be pasted to the peeled off self adhesive surface 13 (FIG 3) and folding in half at centre of width in such a manner that opposite surfaces are pasted on to itself firmly enveloping the extensions.
For a firm grip cut before hand at centre of length and place right side on top of the left to suite neck size thereby completing fixation of position of the tube reducing discomfort of the patient.
With Sterile Disposable Oropharyngeal and Tracheal Tube Fixator
firmly in place it would to lead to avoiding accidental displacement of the intubated tube so that no trauma is caused and the tube does not get blocked to cause respiratory distress.
The soft flannelled Nylex fabric remains in touch of the skin causing no noticeable irritation and the foam does not get rumbled up to form a cord reducing discomfort to the distressed patient and help in nursing providing better care to the patient.

I/We claim
1. A Oropharyngeal and Tracheal Tube Fixator comprising of Foam sheet laminated with soft flannelled Nylex fabric on both surfaces cut to size in three parts - a Band, a Grip and a Clip. The band has both ends sewn with Velcro loop fasteners facing upwards and a peel able double side self adhesive pasted at point, the Grip has a peel able double side self adhesive pasted on one surface end to end and the Clip with extensions of Velcro hook facing upwards sewn at both ends and a peel able double sided self adhesive pasted at centre of length. The Fixator is Gamma radiated, packed in a tamperproof heat sealed one side see through pouch thus being sterile to the point of use.
2. The Fixator as claimed in claim 1 wherein a Foam sheet is laminated on both the surfaces by soft flannelled Nylex fabric by flame lamination process for firm pasting and long life in such a manner to provide soft surface touching the skin of the patient.
3. The Oropharyngeal and Tracheal Tube Fixator claim of claim 1 above wherein Velcro Hook extensions and loop fasteners are made of Polyester sewn in Box fashion with reverse lock stitch.
4. The Oropharyngeal and Tracheal Tube Fixator claim of claim 1 above wherein the adhesive tape is a peel able double side self-adhesive tape to assist in holding the tube firmly as well as enveloping gauze or Velcro Hook extensions
5. The Oropharyngeal and Tracheal Tube Fixator of any one claim of 1 to 5 the foam is of density 16D and of 2 to 3 mm thickness.
6. The Oropharyngeal and Tracheal Tube Fixator of any one claim of 1 to 5 packed in a tamperproof permeable membrane material being see through on one side sterilized by Gamma Irradiation process with a long shelf life and sterile to the point of use.
7. The Oropharyngeal and Tracheal Tube Fixator of any one claim of 1 to 7 is a device to hold firmly in place the intubated Tube in position to avoid accidental displacement during nursing or otherwise.
8. A Oropharyngeal and Tracheal Tube Fixator substantially as herein described and illustrated in the figures of the accompanying drawings.