WO2020169166A1 - A non-traumatic nasal endotracheal tube. - Google Patents

A non-traumatic nasal endotracheal tube. Download PDF

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Publication number
WO2020169166A1
WO2020169166A1 PCT/EG2019/000005 EG2019000005W WO2020169166A1 WO 2020169166 A1 WO2020169166 A1 WO 2020169166A1 EG 2019000005 W EG2019000005 W EG 2019000005W WO 2020169166 A1 WO2020169166 A1 WO 2020169166A1
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WO
WIPO (PCT)
Prior art keywords
tube
nasal
intubation
cuff
junction
Prior art date
Application number
PCT/EG2019/000005
Other languages
French (fr)
Inventor
Hazem ELSERSY
Original Assignee
Elsersy Hazem
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Elsersy Hazem filed Critical Elsersy Hazem
Priority to PCT/EG2019/000005 priority Critical patent/WO2020169166A1/en
Publication of WO2020169166A1 publication Critical patent/WO2020169166A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0461Nasoendotracheal tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0436Special fillings therefor
    • A61M16/0438Liquid-filled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0454Redundant cuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/044External cuff pressure control or supply, e.g. synchronisation with respiration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking

Definitions

  • the present invention relates generally to equipment for medical use and more specifically it relates to a new design of the nasal endotracheal tube that reduces trauma and complications of nasal intubation.
  • Nasotracheal intubation is commonly used to secure airway in oral surgical procedures for the surgeons to have free access to the surgical field. Inserting an endotracheal tube through the nose is also used to bypass huge intraoral masses or structural abnormalities or for limited mouth opening such as trismus and sutured oral cavity.
  • nasotracheal intubation may be used in the intensive care unit to ventilate critically ill patients.
  • Current conventional tubes that are used for nasal intubation lack adequate compressibility to negotiate the nasal passages therefore, its use have resulted in many complications such as, turbinectomy or retropharyngeal dissection bleeding and epistaxis.
  • Epistaxis occurs up to 66% of all nasal intubation and can be life threatening particularly in patients who are predisposed to it.
  • a trauma caused by nasal tube leads to avulsion of the middle turbinate can result insevere epistaxis, cerebrospinal fluid rhinorrhea, injury to olfactory nerve secondary to damage to the cribriform plate, submucosal laceration may result from sharp bent of the advanced tube which predisposes to postoperative pain and infection, retropharyngeal perforation that may result from false tube pathway.
  • postoperative sore throat and tracheal mucosal injury resulting in postoperative cough and pain can occur.
  • one object of the present invention is to provide a nasotracheal tube that will provide a smooth naso-tracheal intubation with substantial reduction of the aforementioned complications and provides more patient and surgeon satisfaction. This is achieved by a soft more compressible lower part of the tube that is prevented from kinking at the ala nasi by a junction mechanism.
  • Another object of the present invention is to facilitate nasal intubation by curving the lower part of the tube to form an angle of 70 degree between its ends to better fit with nasopharyngeal and laryngeal axis.
  • Another object of the present tube is to reduce tracheal mucosal injury and irritation by providing the double ended common lumen cuff where the cuff reservoir can be filled with water soluble jell.
  • Endotracheal tubes have been used for securing the airway providing anesthesia and ventilation for many years. Basically, intubation is provided by one of two main routes, either oral or nasal route. During nasal intubation, the endotracheal tube has to pass through the delicate
  • nasopharyngeal structures in order to reach the naso-pharynx, then should be advanced to the glottis by the help of the Magill forceps. Because all the up to date nasotracheal-tubes are relatively rigid, it always causes trauma to the nasal structures resulting in bleeding, injury to adenoids, turbinate and introduction of debris into the respiratory passages causing
  • the present invention substantially departs from the conventional design of the prior art and provides a novel two portions nasotracheal tube with its soft non-traumatic intubating lower part to prevent trauma of the nasal passages and improve nasal intubation conditions.
  • the prior art while still using the rigid traumatic tube is getting around the problem by adding additional equipment to help in reducing the trauma such as atraumatic introducer for nasal endotracheal tube by Davis in his US patent NO.
  • the striking advantage of the invented tube over the conventionally used ones is that it offers a soft intubating part that can be easily compressed negotiating the narrow nasal passages thus avoiding trauma.
  • this part reaches the nasopharynx, it re-expands by its recoil properties leaving the tube patent.
  • This part is prevented from kinking at the outer nasal opening by a junction mechanism, where a junction between a hard and a soft part is implemented to prevent kinking.
  • the present invention provides a new nasal endotracheal tube construction wherein it can be utilized to provide a nontraumatic and an easier nasotracheal intubation.
  • the general purpose of the present invention is to provide a novel naso-tracheal tube that has many of the advantages of the nasotracheal tubes and many novel features that result in a new endotracheal tube that is not anticipated, rendered obvious, or even implied by any prior art medical equipment either alone or any combination thereof.
  • the present invention generally comprises a two portion naso-tracheal tube that are secured by a junction.
  • the junction mechanism prevents tube kinking at the ala nasi, allows redirection of the tube to facilitate intubation and prevent suction of the lower part by two outer lips and allows the tube to act as a tube and airway by disconnection of the upper part at the end of the procedure.
  • the junction is secured by elastic recoil of the lower portion, a plastic clip and tap.
  • Figure 1 (A, B) is a perspective view of a nasal-endotracheal tube constructed according to the invention.
  • Figure 2 (A, B) illustrates the constituents of the junction of invented the tube.
  • FIG. 3-A Shows the lower soft part of the tube
  • Figure 5 (A, B) reveals the lower portion of the invented tube.
  • the invented tube is comprised of two parts and a junction in between.
  • Part one represents the outer portion of the tube (Fig. 1-2, Fig.4) and it is made more rigid to resist kinking.
  • This part is made from a harder silicon rubber tube that is hard to bend this part will be embedded and travels for two centimeters within the lower part (Fig. 2B-2), In other variety of the tube this part is made from rigid polyvinyl chloride.
  • the upper part of the tube is less by half millimeter in the diameter to strictly fit into the lower part. The upper part is curved and deformed allowing its exit from the nose without exerting pressure on the nasal tissue (Fig.4).
  • the proximal end of the upper part will be embedded for two centimeters in the lower part to form the junction (fig.4-2C, Fig 2B-2).
  • the body of the upper part is deformed to mimic the shape of the nose to avoid exerting pressure on the nasal structures figure (4-2B).
  • the distal end of this part will be connected to the patient circuit.
  • Part two (a lower part) (Fig. 3A): - This lower part of the tube is designed to pass through the nasal passages down to the trachea and its length should extend from the outer nasal nares to the trachea.
  • This portion of the tube is made from softened rubber silicon that has a high compressibility and some degree of recoil, in other variety of the tube this part is made from softened polyvinyl chloride.
  • the purpose of this part is to provide a smooth intubation without causing nasal mucosal disruption or any kind of trauma, (figure 3A).
  • This portion is furtherly modified to suit the intubation process than the conventional tubes does.
  • This portion is furtherly deformed to form a C shaped lower end with a more acute angle between its ends (Fig. 3B).
  • the angle between both ends of this part is equal to 70 degrees (Fig.3B-Al,A2) instead of the obtuse angle of 125-140 degrees between the ends of the conventional nasal tubes (Fig 3B- B1-B2).
  • This modification will help in a better approach to the lower end to the glottic opening facilitating intubation.
  • the junction between the upper and lower part is uniquely designed to avoid disconnection of the two parts or loss of the lower part through the nasal passages by three mechanisms;
  • the lower two centimeters of the upper part is only half millimeter less in diameter and is fitted within the cavity of the lower tube which holds onto it by the elastic recoil of the lower softer part of the tube (Fig.2B [2]).
  • This elastic recoil of the soft part has been tested and it provides a very firm adhesion between the two parts. Additional taping can be applied circumferentially to fix the two parts externally when intubation is successfully fulfilled and no more need to manipulate the tube.
  • the tube kit will be provided by a plastic clip that is applied to the groove of the junction portion to tightly fit the two parts in a way that their separation will be impossible that can be used in case that prolonged intubation is planned such as cases in the intensive care unit ( Figure 2A-[P], fig. 2B-[P]). Benefits of the junction
  • the two circumferential circular thin layers of the junction part are made soft to avoid exerting pressure on the ala nasi and prevent pressure injury and reduce postoperative discomfort (fig. 2-[3-1, 3-2].
  • the upper part can be rotated inside the lower part in all directions (before applying the tape and the plastic clip) and if rotated in a 180 degree it allows direction of the tube tip to facilitate intubation.
  • the outer tube can be removed leaving the inner part which can be withdrawn out of the larynx but may be left in the nasopharynx to work as a nasal airway maintaining easy breathing till complete recovery.
  • This issue will be of economic relevance since we can use the invented tube as a tube and airway saving the expenses of further airway usage.
  • the cuff pressure is the main issue that causes tracheal mucosal injury especially with long term intubation.
  • the pressure exerted by the endotracheal cuff on the wall of the trachea may lead to disruption of the mucosal lining of the tracheal wall and resulting in postoperative sore throat and coughing which can be unpleasant to the patient for several days. So, it is predicted that the reduction of the cuff pressure would improve postoperative related complications.
  • substitution of the inflation vehicle (air) which exerts a high pressure by a less pressing vehicle while maintaining the same volume to prevent aspiration.
  • injection of the medical water soluble jell to fill the cuff instead of air.
  • the merits of the jell is that it is water soluble and can fill the cuff while exerting a soothing minimal pressure on the
  • the first lumen (9A in Fig. 5) is specified for injection of the jell; this lumen distal opening contains no valve but a tight cover that could be used to close the distal end after the jell injection (Fig 5A -9, Fig5B-9).
  • the second lumen (7 in Fig.5 A, 5B) contains a one-way valve that can be used to gauge the cuff pressure with the help of the cuff pressure monitor (7C in Fig 5A, 5B). In addition, it can be used to fill the cuff with air in case this would be preferred by the anesthetist. If air is selected to be used the lumen 9A conveying tube may be occluded by a mosquito forceps to ensure air tight circuit.
  • the tube has two variable forms depending on the material it is made from.
  • PVC polyvinylchloride
  • the length of the nasal tubes is generally determined by Chula formula as follows: -
  • Length of the nasal tube 9+ (Hight in cm/10). This is the length until the nasal nares so, it is the length of the lower part.
  • Cm centimeter
  • L long
  • S short
  • VS very short.
  • Tube internal diameter in millimeter, tubes 4,4.5, 5, 5.5 will be used for children while tubes 6.5, 7, 7.5 will be used in adults.
  • the long tube will be used for males
  • the short tube will be used for females and the very short tubes will be used for patients with short stature or short neck.
  • This tube is supplied in a two separate parts; an upper (hard part) and a lower (soft part).
  • the upper part which will be connected to the patient circuit while the lower part is that part that passes through the nasal passages down to the trachea.
  • the cuff of the tube in the cuffed types is emerging from the lower part.
  • Intubation can be performed in one of the three techniques either using the conventional laryngoscopy or fiber optic bronchoscopy or the blind nasal technique for difficult intubation as follows: -
  • the tube kit should be opened, and the two parts are anchored together by the
  • anesthesiologist by simply inserting the upper part through the lower part and pushing the outer tubal part until the 2 cm prominent mark on the upper portion. Note that these 2 centimeters have a 0.5-millimeter reduction in the internal diameter to firmly fit with the lower portion (fig. 2B-2).
  • the upper portion is then rotated for 180 degrees in order to manipulate the tube during the intubation process.
  • the lower part of the tube is lubricated by jell or medical valine and is made straight by pulling the lower end (note that this part is soft and can be made straight by pulling, then it will retain its C shape by the recoil of the deformed tube).
  • the lower part should be introduced gently into the nose while using a rolling movement to facilitate negotiating the nasal passages.
  • Deforming of the tube by straightening before intubation would facilitate the passage of the tube on the floor of the nose below the inferior turbinate and decrease the likelihood of friction with the middle turbinate.
  • the tube After the tube successfully pass the nasopharynx, it will recoil to its preformed C shape approaching the larynx. If the tube position is at one side or below the larynx then the outer part will be manipulated to adjust the tip of the tube position to pass through the larynx. The tube then will be advanced to the trachea.
  • the outer part of the tube After confirming the proper position of the tube by auscultation and capnography, the outer part of the tube is rotated back to its original position 180 degrees to and attached to the patient circuit. Then both the upper and lower portions of the tube will be held tight by applying the plastic clip to the groove of the junction (fig.2A-P, 2B-P), the cuff is inflated, and the tube is further secured with adhesive tape.
  • One of the advantages of the invented tube is that the fiberoptic bronchoscopy can be used easily and effectively. While fibro-optic cannot be used with the other conventional nasal deformed tubes because of its preformed sharp bents as it is only one piece so the
  • the anesthetist should start intubation using only the lower soft portion of the tube.
  • the fiberoptic is passed through the lumen of the lower part which can be held straight as it is soft and easily manipulated.
  • the fiberoptic is then advanced as usual to pass through the nasal passages and intubate the trachea followed by sliding the lower part of the tube down to the larynx.
  • the lower tube is not completely advanced to touch the ala nasi externally instead, a 2 centimeter between the ala nasi and the external end should be left.
  • the outer tube will be attached to the lower tube travelling for two centimeters into it, then the plastic clip is applied, and the tube junction is pushed further to touch the ala nasi then secured with tap.
  • Fiberoptic nasal intubation may not be limited to situations of unavailability (lack of equipment, expertise, or experience) but also if there is bleeding or secretions in the airway. While blind nasal intubation may be appropriate, it requires special skill and technique.
  • blind nasal intubation One of the valuable methods that was used to manage difficult intubation is the blind nasal intubation.
  • the use of this technique has been declined substantially due to fear of possible complications particularly injury and bleeding with subsequent aspiration.
  • blind nasal intubation can be more safely performed.
  • Blind nasal intubation is a lifesaving intubation technique which basically depends on following the patient breath to intubate the trachea while the patient is awake.

Abstract

A nasal endo-tracheal tube is described that can be used to secure airway, perform oral surgery, deliver ventilation in intensive care unit, reduce complications to nasotracheal intubation and facilitates nasal, blind nasal and difficult intubation. The tube is comprised of two portions; an outer rigid portion to resist kinking and a lower soft portion to prevent trauma. Both portions are connected via a junction that is kept secured by elastic recoil of the lower soft portion, an externally applied plastic clip and taping. The junction contains two lips and a groove; a lower lip that should rest on ala nasi preventing pressure injury to the nose, a groove to accommodate the plastic clip and an upper lip. At the end of operation, the plastic clip is removed, the upper part of the tube is disconnected, and the lower part of the tube is withdrawn to naso-pharynx to act as a nasal airway for recovery. The tube provides a smoother, easier and quicker non- traumatic naso-tracheal intubation.

Description

A non-Traumatic Nasal Endotracheal Tube.
Field of the invention
The present invention relates generally to equipment for medical use and more specifically it relates to a new design of the nasal endotracheal tube that reduces trauma and complications of nasal intubation.
Background of the invention
Nasotracheal intubation is commonly used to secure airway in oral surgical procedures for the surgeons to have free access to the surgical field. Inserting an endotracheal tube through the nose is also used to bypass huge intraoral masses or structural abnormalities or for limited mouth opening such as trismus and sutured oral cavity.In addition, nasotracheal intubation may be used in the intensive care unit to ventilate critically ill patients. Current conventional tubes that are used for nasal intubation lack adequate compressibility to negotiate the nasal passages therefore, its use have resulted in many complications such as, turbinectomy or retropharyngeal dissection bleeding and epistaxis.
Epistaxis occurs up to 66% of all nasal intubation and can be life threatening particularly in patients who are predisposed to it. A trauma caused by nasal tube leads to avulsion of the middle turbinate can result insevere epistaxis, cerebrospinal fluid rhinorrhea, injury to olfactory nerve secondary to damage to the cribriform plate, submucosal laceration may result from sharp bent of the advanced tube which predisposes to postoperative pain and infection, retropharyngeal perforation that may result from false tube pathway. In addition, postoperative sore throat and tracheal mucosal injury resulting in postoperative cough and pain can occur.
Due to these catastrophic complications of nasotracheal intubation a demand for non-traumatic nasotracheal tube is crucial. It is therefore one object of the present invention is to provide a nasotracheal tube that will provide a smooth naso-tracheal intubation with substantial reduction of the aforementioned complications and provides more patient and surgeon satisfaction. This is achieved by a soft more compressible lower part of the tube that is prevented from kinking at the ala nasi by a junction mechanism.
Another object of the present invention is to facilitate nasal intubation by curving the lower part of the tube to form an angle of 70 degree between its ends to better fit with nasopharyngeal and laryngeal axis. Another object of the present tube is to reduce tracheal mucosal injury and irritation by providing the double ended common lumen cuff where the cuff reservoir can be filled with water soluble jell.
Description of the related art
Any discussion of the prior art throughout the specification should in no way be considered an admission that such prior art is widely known or forms a part of common general knowledge in the field.
Endotracheal tubes have been used for securing the airway providing anesthesia and ventilation for many years. Basically, intubation is provided by one of two main routes, either oral or nasal route. During nasal intubation, the endotracheal tube has to pass through the delicate
nasopharyngeal structures in order to reach the naso-pharynx, then should be advanced to the glottis by the help of the Magill forceps. Because all the up to date nasotracheal-tubes are relatively rigid, it always causes trauma to the nasal structures resulting in bleeding, injury to adenoids, turbinate and introduction of debris into the respiratory passages causing
contamination and infection. The bleeding may be so severe that it can obscure the field of vision for intubation resulting in hypoxemia. There have been several trials for reducing nasal trauma none of them yielded a satisfactory result simply because they still use the rigid tube that results in injury and trauma. In these respects, the present invention substantially departs from the conventional design of the prior art and provides a novel two portions nasotracheal tube with its soft non-traumatic intubating lower part to prevent trauma of the nasal passages and improve nasal intubation conditions. The prior art while still using the rigid traumatic tube is getting around the problem by adding additional equipment to help in reducing the trauma such as atraumatic introducer for nasal endotracheal tube by Davis in his US patent NO. 8,561,605 who provided a dilator to guide passing of the nasal tube while this method can help direct the tube pathway, it is still resulting in substantial trauma due to the use of the same rigid nasal tube for intubation. Moreover, the use of this introducer will delay intubation due to necessity of removing it from the mouth, in addition to the additional cost of buying a separate equipment for the intubation purpose. A nasal intubation apparatus was invented by Bullard in his US patent NO. 5,842,973, the aim of this apparatus is to assist in the nasal intubation. Again, in addition to the cost of the device, there are no modifications done in the tube consistency and a substantial trauma is not avoided. Similarly, many trials to reduce nasal trauma has been addressed in the literature using a red rubber catheter guide, urethral catheter guide, dilatation by nasal trumpets and bougie guides. None of which has yielded a satisfactory result because it did not address the main issue which is the rigidity of the intubating tube relative to nasal passages. The use of the known parker flex-tip tube for nasal intubation with the assumption that the tip of the tube is the cause of trauma however, the results of such modification are not satisfactory for the same reason of using a relatively rigid tube. Passing a rigid tube through the nasal passages offers a great deal of resistance to compression and this issue leads to unavoidable trauma to the nasal structures as the tube dissects its way. The striking advantage of the invented tube over the conventionally used ones is that it offers a soft intubating part that can be easily compressed negotiating the narrow nasal passages thus avoiding trauma. When this part reaches the nasopharynx, it re-expands by its recoil properties leaving the tube patent. This part is prevented from kinking at the outer nasal opening by a junction mechanism, where a junction between a hard and a soft part is implemented to prevent kinking.
Brief summary of the invention
In the view of the foregoing disadvantages inherent in the known types of the endo-tracheal tubes now present in the prior art, the present invention provides a new nasal endotracheal tube construction wherein it can be utilized to provide a nontraumatic and an easier nasotracheal intubation.
The general purpose of the present invention, which will be described subsequently in more detail, is to provide a novel naso-tracheal tube that has many of the advantages of the nasotracheal tubes and many novel features that result in a new endotracheal tube that is not anticipated, rendered obvious, or even implied by any prior art medical equipment either alone or any combination thereof.
To attain this, the present invention generally comprises a two portion naso-tracheal tube that are secured by a junction. An outer rigid part to resist kinking and a lower soft part to provide soft non-traumatic intubation. The junction mechanism prevents tube kinking at the ala nasi, allows redirection of the tube to facilitate intubation and prevent suction of the lower part by two outer lips and allows the tube to act as a tube and airway by disconnection of the upper part at the end of the procedure. The junction is secured by elastic recoil of the lower portion, a plastic clip and tap.
There has been thus outlined rather broadly, the more important 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 hereto.
In this respect, it is to be understood that the invention is not limited ip its application to the details of construction and 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 other ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
Brief description of the figures
The figures are represented in pictures and drawings, the pictures were taken from an assembled model of the tube for clarification purpose only.
Figure 1 (A, B) is a perspective view of a nasal-endotracheal tube constructed according to the invention.
Figure 2 (A, B) illustrates the constituents of the junction of invented the tube.
Figure 3-A Shows the lower soft part of the tube
3-B- reveals the difference in curvature between the invented tube and the conventional tubes. Figure 4 Shows the first portion of the invented tube.
Figure 5 (A, B) reveals the lower portion of the invented tube.
Detailed description of the invention
A well-known problem of the use of too soft tubes is that this tube will be kinked at the outer opening of the nose which would offer a great deal of airway resistance so that it renders ventilation difficult with resultant hypercarbia, high airway pressure and tube obstruction with critical cessation of gas-flow. So, what basically we do need is a soft tube that should not be kinked.
To overcome these problems, I have designed a new tube model that would fit these requirements; a two separate parts tube where each part represent unique physical characteristics to suit the purpose that it is designed for. Getting around the problem revealed three main problems in the related art that require solution: -
1- All the available nasal endotracheal tubes are relatively rigid and less compressible while passing through the narrow nasal airway so, trying to insert these tubes can result in substantial injuries specially with abnormal nasal anatomy.
2- The curve of the existing nasal tubes is more obtuse, and the tube always pass
significantly below the glottic opening which mandates the use of Magill forceps to redirect the tube to upper plane to intubate the trachea. This issue may result in further injury from the Magill forceps during forcing of the tube into the glottic opening.
3- Despite the cuff of endotracheal tubes are high volume low pressure but still this
pressure is significantly affecting the tracheal mucosa and may result in postoperative sore throat.
Description of the invented tube
The invented tube is comprised of two parts and a junction in between.
Part one (an upper part): - This part represents the outer portion of the tube (Fig. 1-2, Fig.4) and it is made more rigid to resist kinking. This part is made from a harder silicon rubber tube that is hard to bend this part will be embedded and travels for two centimeters within the lower part (Fig. 2B-2), In other variety of the tube this part is made from rigid polyvinyl chloride. The upper part of the tube is less by half millimeter in the diameter to strictly fit into the lower part. The upper part is curved and deformed allowing its exit from the nose without exerting pressure on the nasal tissue (Fig.4). The proximal end of the upper part will be embedded for two centimeters in the lower part to form the junction (fig.4-2C, Fig 2B-2). The body of the upper part is deformed to mimic the shape of the nose to avoid exerting pressure on the nasal structures figure (4-2B). The distal end of this part will be connected to the patient circuit. (Fig. 1-1, Fig.4A). Part two (a lower part) (Fig. 3A): - This lower part of the tube is designed to pass through the nasal passages down to the trachea and its length should extend from the outer nasal nares to the trachea. This portion of the tube is made from softened rubber silicon that has a high compressibility and some degree of recoil, in other variety of the tube this part is made from softened polyvinyl chloride. The purpose of this part is to provide a smooth intubation without causing nasal mucosal disruption or any kind of trauma, (figure 3A). This portion is furtherly modified to suit the intubation process than the conventional tubes does. This portion is furtherly deformed to form a C shaped lower end with a more acute angle between its ends (Fig. 3B). The angle between both ends of this part is equal to 70 degrees (Fig.3B-Al,A2) instead of the obtuse angle of 125-140 degrees between the ends of the conventional nasal tubes (Fig 3B- B1-B2). This modification will help in a better approach to the lower end to the glottic opening facilitating intubation.
A Junction: - (Fig.2A, Fig.2B)
The junction between the upper and lower part is uniquely designed to avoid disconnection of the two parts or loss of the lower part through the nasal passages by three mechanisms;
1- The lower two centimeters of the upper part is only half millimeter less in diameter and is fitted within the cavity of the lower tube which holds onto it by the elastic recoil of the lower softer part of the tube (Fig.2B [2]). This elastic recoil of the soft part has been tested and it provides a very firm adhesion between the two parts. Additional taping can be applied circumferentially to fix the two parts externally when intubation is successfully fulfilled and no more need to manipulate the tube.
2- The upper end of the lower part of the tube has a circumferential outer shelf that would rest on the nares preventing the downward suction of that part (Figure 2 A [ 3-1, 3-2], Fig. 2B [3-1, 3-2]).
3- The tube kit will be provided by a plastic clip that is applied to the groove of the junction portion to tightly fit the two parts in a way that their separation will be impossible that can be used in case that prolonged intubation is planned such as cases in the intensive care unit (Figure 2A-[P], fig. 2B-[P]). Benefits of the junction
It allows using two parts of the tube with different consistencies that would fit its function; the lower part with its soft consistency and a good degree of recoil that negotiates the nasal passages and avoid its injury and the upper part of the tube with a rigid consistency to resist kinking of the tube at the nasal outlet.
The two circumferential circular thin layers of the junction part are made soft to avoid exerting pressure on the ala nasi and prevent pressure injury and reduce postoperative discomfort (fig. 2-[3-1, 3-2].
Furthermore, the upper part can be rotated inside the lower part in all directions (before applying the tape and the plastic clip) and if rotated in a 180 degree it allows direction of the tube tip to facilitate intubation.
At the conclusion of the surgical procedure the outer tube can be removed leaving the inner part which can be withdrawn out of the larynx but may be left in the nasopharynx to work as a nasal airway maintaining easy breathing till complete recovery. This issue will be of economic relevance since we can use the invented tube as a tube and airway saving the expenses of further airway usage.
Modification of the cuff (fig. 5 A, 5B)
The cuff pressure is the main issue that causes tracheal mucosal injury especially with long term intubation. The pressure exerted by the endotracheal cuff on the wall of the trachea may lead to disruption of the mucosal lining of the tracheal wall and resulting in postoperative sore throat and coughing which can be unpleasant to the patient for several days. So, it is predicted that the reduction of the cuff pressure would improve postoperative related complications. To achieve this goal, substitution of the inflation vehicle (air) which exerts a high pressure by a less pressing vehicle while maintaining the same volume to prevent aspiration. Thus, injection of the medical water soluble jell to fill the cuff instead of air. The merits of the jell is that it is water soluble and can fill the cuff while exerting a soothing minimal pressure on the
surrounding tracheal mucosal wall. To fulfill this, I have designed a double end common lumen cuff (Figure 5A,5B). Both lumens merge to meet each other and pour into the common lumen (Fig. 5-8). The first lumen (9A in Fig. 5) is specified for injection of the jell; this lumen distal opening contains no valve but a tight cover that could be used to close the distal end after the jell injection (Fig 5A -9, Fig5B-9). The second lumen (7 in Fig.5 A, 5B) contains a one-way valve that can be used to gauge the cuff pressure with the help of the cuff pressure monitor (7C in Fig 5A, 5B). In addition, it can be used to fill the cuff with air in case this would be preferred by the anesthetist. If air is selected to be used the lumen 9A conveying tube may be occluded by a mosquito forceps to ensure air tight circuit.
The forms of invented tube
1-Nasal uncuffed
2-Nasal cuffed with ordinary cuff
3-Nasal cuffed with double end- common lumen cuff.
The tube has two variable forms depending on the material it is made from.
1-A rubber silicon made tubes where the lower part is softened to meet the criteria of nontraumatic intubation and the upper part which is made hard to resist kinking-
2- A polyvinylchloride (PVC) made tubes where the lower part is softened to meet the criteria of nontraumatic intubation, and the upper part is made hard to resist kinking. The purpose of PVC tubes is to reduce the expenses and coast to the consumer. This form can be used for shorter operations. The length of the tube
The length of the nasal tubes is generally determined by Chula formula as follows: -
Length of the nasal tube = 9+ (Hight in cm/10). This is the length until the nasal nares so, it is the length of the lower part.
While the Chula formula considers only the body Hight in determining the suitable length of nasotracheal tube and because there are other factors that play an important role in determination of the suitable length of the tube such as, the length of the neck and the position of the patient during operation. So, for each tube I have considered three lengths of the nasal tubes namely long, short and very short. The issue of providing different lengths to the nasal- tracheal tube enables the anesthesiologist to select the suitable size and length among the given tubes based on the patient height, gender, neck length and the supposed position of the patient (tablel).
The details of the length of the tube is clarified in the following table.
Tablel: - The designed lengths of the nasal endotracheal tubes
Figure imgf000013_0001
This table displays the different lengths of the invented nasal tubes. Length to nares= length of the tube in centimeters from the intubating end (that will be in the med-trachea and the nares (junction of the tube), Length from nares= the length of the tube in centimeters from the junction till the patient circuit. Cm= centimeter, L= long, S= short, VS= very short. Tube internal diameter in millimeter, tubes 4,4.5, 5, 5.5 will be used for children while tubes 6.5, 7, 7.5 will be used in adults. The long tube will be used for males, the short tube will be used for females and the very short tubes will be used for patients with short stature or short neck. The intubation Methods Using invented tube.
This tube is supplied in a two separate parts; an upper (hard part) and a lower (soft part). The upper part which will be connected to the patient circuit while the lower part is that part that passes through the nasal passages down to the trachea. The cuff of the tube in the cuffed types is emerging from the lower part. Intubation can be performed in one of the three techniques either using the conventional laryngoscopy or fiber optic bronchoscopy or the blind nasal technique for difficult intubation as Follows: -
1-Using the Indirect Laryngoscope
The tube kit should be opened, and the two parts are anchored together by the
anesthesiologist by simply inserting the upper part through the lower part and pushing the outer tubal part until the 2 cm prominent mark on the upper portion. Note that these 2 centimeters have a 0.5-millimeter reduction in the internal diameter to firmly fit with the lower portion (fig. 2B-2). The upper portion is then rotated for 180 degrees in order to manipulate the tube during the intubation process. After anesthesia induction and putting the vasoconstrictor drops on the nostrils the lower part of the tube is lubricated by jell or medical valine and is made straight by pulling the lower end (note that this part is soft and can be made straight by pulling, then it will retain its C shape by the recoil of the deformed tube). Then the lower part should be introduced gently into the nose while using a rolling movement to facilitate negotiating the nasal passages. Deforming of the tube by straightening before intubation would facilitate the passage of the tube on the floor of the nose below the inferior turbinate and decrease the likelihood of friction with the middle turbinate. After the tube successfully pass the nasopharynx, it will recoil to its preformed C shape approaching the larynx. If the tube position is at one side or below the larynx then the outer part will be manipulated to adjust the tip of the tube position to pass through the larynx. The tube then will be advanced to the trachea. After confirming the proper position of the tube by auscultation and capnography, the outer part of the tube is rotated back to its original position 180 degrees to and attached to the patient circuit. Then both the upper and lower portions of the tube will be held tight by applying the plastic clip to the groove of the junction (fig.2A-P, 2B-P), the cuff is inflated, and the tube is further secured with adhesive tape.
2-Using the fiber-optic bronchoscope.
One of the advantages of the invented tube is that the fiberoptic bronchoscopy can be used easily and effectively. While fibro-optic cannot be used with the other conventional nasal deformed tubes because of its preformed sharp bents as it is only one piece so the
bronchoscope needs to be sharply bent several times and this will obscure the vision. To use the fiberoptic with the invented tube the anesthetist should start intubation using only the lower soft portion of the tube. The fiberoptic is passed through the lumen of the lower part which can be held straight as it is soft and easily manipulated. The fiberoptic is then advanced as usual to pass through the nasal passages and intubate the trachea followed by sliding the lower part of the tube down to the larynx. The lower tube is not completely advanced to touch the ala nasi externally instead, a 2 centimeter between the ala nasi and the external end should be left. After removal of the fiberoptic the outer tube will be attached to the lower tube travelling for two centimeters into it, then the plastic clip is applied, and the tube junction is pushed further to touch the ala nasi then secured with tap.
3-Blind nasal intubation
Inability to use fiberoptic nasal intubation may not be limited to situations of unavailability (lack of equipment, expertise, or experience) but also if there is bleeding or secretions in the airway. While blind nasal intubation may be appropriate, it requires special skill and technique.
One of the valuable methods that was used to manage difficult intubation is the blind nasal intubation. The use of this technique has been declined substantially due to fear of possible complications particularly injury and bleeding with subsequent aspiration. Now and after introduction of the present invention blind nasal intubation can be more safely performed.
Blind nasal intubation is a lifesaving intubation technique which basically depends on following the patient breath to intubate the trachea while the patient is awake.

Claims

Claims
The present invention has its unique novel points that need to be protected under patent law. Obviously, the invention is not to be limited by the embodiment shown in the drawing and described in the description which is given by the way of example and not limitation but only in the scope of the appended claims.
What is claimed is:
1-A nasal endotracheal tube for airway management, providing anesthesia, ventilation and non-traumatic nasal intubation, comprised of, an upper portion, a junction and a lower portion. The tube is made in different forms to suit different situations; a double end common lumen cuffed tube, a single end cuffed tube and an uncuffed tube.
2- the upper portion said in claim 1 is deformed to avoid nasal compression and is made hard to resist kinking.
3- The internal diameter of the said upper portion of the tube in claim 1 is 0.5 millimeters less than that of the said lower portion.
4- The said lower portion in claim 1 is soft in consistency to reduce nasal passages trauma and is deformed to make a C shaped structure with an angle of 70 degree between its ends to better align the tube with glottis for easy intubation.
5- The said junction in claim 1 is formed by travelling of the said upper hard part through the said lower soft part for two centimeters. The lower end of the said upper part is oval in shape with an opening facing backwards. At the upper end of the said lower part in claim 1 a groove between two lips to accommodate a plastic clip for securing the junction.
6- The said junction in claim 1 is secured by certain features comprising the soft recoil of the said lower soft portion, the externally applied plastic clip said in claim 5 and tape.
7- The said two lips in claim5 comprise a lower lip that extends beyond the nasal opening to prevent suction or loss of the lower part in the nasal airway; a groove for application of the said plastic clip and an upper lip at the end of the said lower portion.
8- The said double ended common lumen cuffed tube in claim 1 is equipped with two cuff-ends that pour into a common path. A filling cuff that is sealed with a removable cover and contains no valve and a gauging cuff equipped with a one-way valve.
9- the said filling cuff in claim 8 is used to inject water soluble jell to fill the cuff while, the said gauging cuff is used to monitor the cuff pressure or can be used to inject air.
10- The said single end cuffed tube in claim 1 contains only the gauging cuff for air injection and gauging.
11- The said uncuffed tube in claim 1 contains no cuff.
12- The said junction in claim 1 provides a mechanism by which the tube can be manipulated to perform different functions; by rotating the said upper part in claim 1 to 180 degrees (before securing the junction with the said plastic clip in claim 5) the tip of the tube can be manipulated to assess intubation; by removing the said upper part in claim 1 at the end of operation and withdrawing the said lower part to nasopharynx the lower part can act as a nasal airway; It allows the use of two parts of the tube with variable consistencies to match the purpose implemented for; the said lower soft portion can be used to assess fiberoptic intubation before connecting the hard upper part.
13- A method of recovering the patient using the said lower portion of the said nasotracheal tube in claim 1.
The method comprising. At the end of surgical procedure and on attaining spontaneous breathing and reversal of muscle relaxant, removing the plastic clips and tape then
disconnecting the said upper portion in claim 1 then withdrawing the said lower portion in claim 1 to naso-pharynx so, the said lower part of the said tube in claim 1 functions as a nasal airway. Thus, avoiding extra-equipment cost and trauma.
14- A method of intubation for difficult airway. The use of the said nasal endotracheal tube in claim 1 using the blind nasal technique for difficult intubation, the more acute curve of the said lower part in claim 1 provides better approach to the larynx particularly high anterior larynx found in difficult intubation sitting, providing better navigation than that of the conventional tubes. 15- A method for blind nasal intubation. Blind nasal has declined because of the bleeding associated trauma of the conventional nasal tubes. Using the present invented tube provides bloodless field due to passing a soft tube enabling clearer field and reducing aspiration risk.
16- A method for decreasing postoperative sore throat. By using the said double ended common lumen cuffed tube in claim 1 and injection of water soluble jell which will exert less pressure on the tracheal mucosal lining therefore, reducing irritation and sore throat.
17- A use of the said double ended cuff for oral endotracheal tube and filling the filling cuff with water soluble jell to reduce post-operative sore throat in operation requiring oral intubation.
18- The said nasotracheal tube in claim 1 is supplied in three lengths; usual, short and ultrashort depending on patient length, gender and neck length.
19- The said nasotracheal tube in claim 1 has two variants in terms of what it is made from; variant R and variant P.
20- The said variant R in claim 19 is made from rubber silicon where the said lower portion in claim 1 is made soft and the said upper portion in claim 1 is made hard.
21- The said variant P in claim 18 is made of polyvinylchloride where the said lower portion in claim 1 is made soft and the said upper portion in claim 1 is made rigid.
22- the said double end cuffed endotracheal tube in claim 1 can be used in the intensive care unit either as an oral or as a nasal tube for prolonged ventilation to decrease complications due to lowering of the cuff pressure by using the water soluble jell.
23- The said double ended common lumen cuff in claim 1, in addition to its use in the nasal endotracheal tube, can be included in all forms of endotracheal tubes including but not limited to oral endotracheal tubes, double lumen tubes, preformed and reinforced tubes of all variants and for all available sizes and lengths to inject water soluble medical jell to fill the cuff in order to reduce the cuff pressure and its complications.
24- The said nasotracheal tube in claim 1 is available in all sizes suitable for all ages of the man kind ranging from 2 to 8-millimeter internal diameter.
PCT/EG2019/000005 2019-02-18 2019-02-18 A non-traumatic nasal endotracheal tube. WO2020169166A1 (en)

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