WO2017031413A1

WO2017031413A1 - Endotracheal tube with traction string to facilitate intubation

Info

Publication number: WO2017031413A1
Application number: PCT/US2016/047744
Authority: WO
Inventors: Juan WALTERSPIEL
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-08-20
Filing date: 2016-08-19
Publication date: 2017-02-23
Anticipated expiration: 2018-02-20

Abstract

An embodiment of this invention includes an endotracheal tube having am airflow lumen, a tension string conduit comprising a traction string, which can facilitate and accelerates non-traumatic intubation. An embodiment includes a traction string attached at the distal end of tip of a traction string conduit, and exits at the proximal end of the endotracheal tube where it can be attached to a pull ring sized to fit on a finger of an operator's hand. Applying tension to the traction string exerts a controlled bending the tip of the endotracheal tube. An embodiment further comprises inserting an endotracheal tube and severing the traction string after intubation is accomplished.

Description

INTERNATIONAL PCT PATENT APPLICATION FOR

ENDOTRACHEAL TUBE WITH TRACTION STRING TO FACILITATE INTUBATION

Claim of Priority

This International PCT application claims priority to United States provisional patent application No. 62/207,554 filed 20 August 2015 entitled: "Endotracheal Tube With Traction String To Facilitate Intubation. This provisional application is herein incorporated fully by reference.

Field of the Disclosure

This disclosure relates to devices and methods to accelerate and facilitate endotracheal intubation. This disclosure relates particularly to a endotracheal tube having a traction string suitable for bending the tip of the endotracheal tube to permit a user to direct the endotracheal tube more accurately and with decreased likelihood of causing trauma to an animal's tissues. More particularly, this disclosure relates more particularly to devices and methods for intubation of a small animal or a patient, and with a decreased risk of causing trauma.

BACKGROUND

Endotracheal intubation, particularly of neonates, requires both dexterity and ongoing practice. The tip of an endotracheal tube has to slide over the epiglottis and curve into the trachea in order not to slip into the esophagus, which can asphyxiate the patient. Several conventional techniques are used to accomplish this. These include cooling or "icing" a tube in advance to render it more rigid, grasping the tip of the tube with a McGill forceps through the mouth to direct it into the trachea, and most commonly, the in advance placement of a rigid wire into a tube, to stiffen it and to keep the tip bent upwards. SUMMARY

All of these techniques and methods can cause delays in intubation, and a stiffened or forcefully directed tube can traumatize the epiglottis and pharynx. Therefore, there is need in the art to provide improved intubation devices and methods. This disclosure has solved this problem and is directed to improving the ability of a practitioner to quickly and accurately intubate a patient, including neonatal patients. The operator holds an endotracheal tube of this disclosure having a flexible distal tip with the hand that performs the intubation, while the other hand remains free to handle a laryngoscope. An endotracheal tube has a bore of sufficient diameter to permit the intubated patient to breath either on his/her own or with assisted ventilation.

An endotracheal tube of this disclosure incorporates a second bore ("traction string conduit") that has a traction string attached to a distal, flexible tip of the endotracheal tube and tension can be applied to the proximal end of a traction string extending outside the endotracheal tube. Using a traction string, an operator can bend the flexible tip of the endotracheal tube by pulling on a traction string running in a tension string conduit in a lateral wall of the endotracheal tube along its concave side. A traction string can be connected to a pull ring that can fit on an operator's finger. The traction string and pull ring can be cut off after the intubation is accomplished. Embodiments of this disclosure do not occlude the endotracheal tube and keeps it soft and pliable in order to avoid any trauma during intubation. Ease and speed of intubation, and the avoidance of asphyxia and trauma are the advantages that embodiments of this disclosure offers. These advantages render this invention especially important for the intubation of neonates.

BRIEF DESCRIPTION OF THE FIGURES

This invention is described with respect to specific embodiments thereof. Other features of this invention can be appreciated with reference to the figures, in which:

FIG. 1A depicts a schematic side view drawing 100 of an operator's gloved hand holding endotracheal tube 105 of this disclosure having a concave side 115 with traction string within longitudinal traction string conduit (not shown; see FIG. IB) within the wall along the concave side 115 of tube 105, a stabilization ring 120 the exit of the traction string 125, and a pull ring 130, that fits on the middle, ring, or small finger, here shown on a middle finger.

FIG. IB depicts a longitudinal section of embodiment as depicted in FIG. 1A. A portion of endotracheal tube 105 has air flow lumen 117 and conduit 116 within tube 105. Conduit 116 is shown within the concave side of tube 105. Traction string 110 is shown within conduit 116.

FIG. 1C depicts a longitudinal view 100 of endotracheal tube 105 of this disclosure having an exit 125 through which traction string 110 passes from traction string conduit 116 through the side wall of tube 105. Proximal end of traction string 110 is shown attached to a pull ring, and distal end of traction string is affixed to the distal tip of the traction string conduit. When tension is applied to traction string 110, the distal tip of endotracheal tube 105 is forced laterally (see FIG. 1A).

FIG. 2 depicts a schematic cross-section view 200 of endotracheal tube 105 of this disclosure. Air flow lumen 117 and traction string conduit 116 are shown within endotracheal tube 105. Traction string 110 is shown within traction string conduit 116.

FIG. 3 depicts a side view 300 of an embodiment of this disclosure having endotracheal tube 105 in a relaxed position 105a (dashed lines), and when traction string 110 is pulled, the tip of the endotracheal tube is shown forced into a lateral position 105b.

FIG. 4 depicts a side view 400 of an embodiment of this disclosure, having endotracheal tube 105 in relaxed position 105a (dashed lines) and in flexed (lateral) position 105b. Convex side of endotracheal tube 105b is shown having thin wall 107 at the distal end of tube 105.

FIG. 5 depicts a side view 500 of an embodiment of this disclosure, depicting endotracheal tube 105 in relaxed position 105a (dashed lines) and in flexed (lateral) position 105b, and corrugated wall 108 at the distal end of the tube 105.

DETAILED DESCRIPTION

Existing intubation assisting devices comprise armored laryngeal tubes that have a wire embedded to attain a special shape, bendable trocars (wires), various introducers over which an endotracheal tube can slide, elastic bougies (thin, flexible surgical instruments for exploring or dilating a passage of the body), light "wands", and flexible fiber-optic devices that are used to ease and assist in intubation. (Anesthesiology, David. E. Longenecker et al. Ed. McGraw-Hill, NY, 2012 ISBN 13 - 9780071744690). Additionally, devices having two bent or otherwise connected fishing lines, or re-usable banjo-string wires introduced into a curved endotracheal tube, where traction on either one of them is followed by a bending of the tube and particularly of its tip. A further device, with the trade name Parker Flex-it, includes a compression member attached to a string at its distal end with the string secured proximally to an insert is introduced into a tube. The curvature of the tube is augmented and the tip lifted by pushing said compression member into the tube. Prior art devices pose a danger of perforation of sensitive tissues should they break or be inserted too far. Most or all existing devices can impose a risk of occluding the endotracheal tube while the patient is in the process of being intubated, thereby preventing the patient from being ventilated. More elaborated ones may be available to anesthesiologists only, whereas the simple, inexpensive, non-occluding devices integrated into an endotracheal tube are not available, regardless of where and under what circumstances and skill sets the intubation has to take place.

To provide improved endotracheal tubes, this disclosure provides relatively simple, inexpensive devices being easy to use, and not invoking the risks associated with prior art devices.

In an embodiment, an improved endotracheal tube comprises a first lumen ("air flow lumen") for passage of air and a second lumen ("traction string conduit") in the wall on what will be a concave side. A traction string is attached to the distal tip of the traction string conduit within the endotracheal tube. In an embodiment, the traction string exits the endotracheal tube at the proximal end of the tube and is attached to a pull ring that fits loosely on the operator's finger. Bending of the finger can exert a controlled pull on the traction string, which in turn bends or flexes the tip of the tube, while leaving the remainder of the tube in its original soft state to avoid trauma. In an embodiment, the traction string and pull ring can be cut off once intubation is accomplished. Keeping the tube and the tip soft and pliable can be desirable for the intubation of neonates and can eliminate the use of a wire within the air flow lumen of the tube, cooling or "icing" to stiffen it, or a Mc Gill forceps to direct it, all of which are prone to cause trauma.

An additional embodiment, by itself or combined with the above described embodiment, includes the tip of the tube to point upwards from the concave curvature of the tube in order for the tip to find a desired direction over the epiglottis. This is in contrast to the traditional sideways pointing position of the tip. A traction string originates from the upwards pointing tip in a possible combination embodiment.

An additional embodiment, by itself or combined with the above described embodiments, includes a thinned and/or corrugated area of a second lumen that is situated within the circular wall of the air flow lumen, under the endotracheal tube's tip, in order to allow the endotracheal tube tip to bend in ta desired direction. The distal end of a traction string can then originate from an upwards pointing tip described in an embodiment above, or from the upper middle rim of a conventional sideways pointed tip in a combination embodiment. Optionally, a distal tip of an endotracheal tube may have an inflatable cuff that when inflated, can provide a seal between the endotracheal tube and the animal's airway.

It can be appreciated that persons of ordinary skill in the art can modify the disclosures and teachings herein to produce additional embodiments without undue experimentation and with a likelihood of success. Each of those embodiments is considered part of this invention.

Manufacture of Endotracheal Tube

To manufacture an endotracheal tube of this disclosure, a tube is produced having an airflow lumen and a more laterally located tension string conduit. Resilient, flexible materials for endotracheal tubes can include pliable plastics, such as polyvinyl chloride (PVC) The material for the tube can be polyvinyl chloride (PVC), silicone, metal wrapped rubber or equally wrapped silicone. Material for the tension string conduit can be the same as the one of the endotracheal tube. The tension string conduit can be encased by or ringed with a harder form of PVC or silicone for the traction string not to cut into the concave "roof of the traction string conduit when tensed. The traction string can fashioned of any braided or non-braided material of appropriate thickness that would not stretch excessively and be able resist the tensile forces generated during the curving of the endotracheal tube.

An endotracheal tube of this disclosure can be made of a radio-opaque material, or mixed with a radio-opaque material to serve as an x-ray-opaque marker for visualizing the endotracheal tube. In an embodiment, a material may be non-metallic or other material that does not interfere with imaging by magnetic resonance.

A pull ring can have a smooth surface and can be made from wood, metal, polyvinyl chloride (PVC) polyethylene (PE), polyethylene terephthalate (PET), polypropylene (PP), polydemethylsiloxane, fluoroplastics, polystyrene, and other types of hardened plastics and combinations. It can be color coded for the size of the tube.

Materials may be transparent and/or colored that fulfill the sterility, sterilizability, visibility, and flexibility requirements for repeated use.

Once a tube is prepared, a tension string is disposed within a tension string conduit, and the distal end of the tension string is affixed to the inner aspect of the distal end of a tension string conduit. In an embodiment, the distal end of the tension string remains within the tension string conduit and does not protrude from the distal end of the conduit. Retention of the distal end of the tension string within the conduit can protect the patient from trauma caused by the string itself. The proximal end of a tension string is then disposed through an exit hole in the side of the endotracheal tube and affixed to a pull ring.

After manufacture, an endotracheal tube is then sterilized using a conventional method. It can be appreciated that there can be a variety of sizes of endotracheal tubes of this disclosure. For use in neonates, and endotracheal tube can have an outside diameter of less than the inside diameter of the patient's airway, for example, between 3 and 10 mm, alternatively, between about 2 and 5 mm, or for even smaller patients, from about 2 to 3 mm. For larger patients, including children, teenagers, and adults, endotracheal tubes can have an outside diameter between about 5 and 15 mm, alternatively between about 5 and 10 mm, and alternatively, between about 5 and 7 mm. Inside diameters of endotracheal tubes can range from the standard, smallest 2.5 mm inner diameter tubes for premature neonates, to 3, 3.5, or 4 mm inner diameter and up pediatric tubes to various forms of endotracheal tubes for adults, each at their standard recommended lengths.

EXAMPLES

The following examples are intended to illustrate specific embodiments of this invention, and are not intended to limit the scope of the invention. Example 1: Endotracheal Tubes of This Disclosure

An operator can grip the proximal end of an endotracheal tube and a finger can be inserted through a pull ring. The distal end of an endotracheal tube can then be inserted into the patient's airway, and under visual observation (using a laryngoscope) the operator can flex the distal tip of the endotracheal tube by applying tension via the pull ring. In situations in which the direction of flexion is aligned with the structure of the patient's airway, the distal tip can easily pass by a structure (e.g., epiglottis, larynx, etc.). In situations in which the direction of flexion is not aligned with the structure of the patient's airway, an operator can rotate the endotracheal tube using the proximal end of the tube.

Example 2: Structure of Endotracheal Tube of this Disclosure

A thin wall of flexible material can permit an endotracheal tube to flex without requiring high tension being applied to a tension string.

A corrugated wall can permit an endotracheal tube to flex without requiring as high tension being applied to a tension string. Example 3: Intubation Using Endotracheal Tubes of this Disclosure

For intubation of a human patient, the patient is lying face up on a table, bed, or gurney. An intubator stands behind the patient's head the patient's nose heading up to him. The intubator then introduces the laryngoscope (a straight one or a curved Mackintosh) with its light, through the patient's mouth and ends up depressing/pulling up the patients tongue with the instrument, visualizing the epiglottis, from which the trachea (windpipe) starts right behind, and towards the back wall where the esophagus commences leading into the stomach.

The intubator then introduces the tip of the endtotracheal tube over the epiglottis (from through the nose or over the tongue and/or laryngoscope blade) and curves the tip of the tube from this position to slide over the epiglottis into the windpipe, and avoids the tip hitting the wall. Hitting the wall may have the undesirable effect of permitting the endotracheal tube to slide into the esophagus. The tip of the endotracheal tubes may be positioned sideways to the left opening and is kept overall in the center, to "curve" "up" and over the epiglottis into the windpipe. The tip of the tube therefore in spite of the lateral opening to the left, curves upwards, toward the ceiling of the room.. This curving up along the plane of the concave bend of the tube is one aspect of this disclosure. Any "sideways" or lateral bend would be detrimental although the tip of the tube, in practical terms, is sometimes held a millimeter sideways to the left of the intubator, to aim at the center of the space behind the epiglottis, where the trachea starts. Advantages

Embodiments of this invention represent an improvement in the art by providing an operator to adjust the angle of a distal tip of an endotracheal tube, thereby permitting the operator to insert the endotracheal tube into an animal while decreasing the likelihood of causing trauma to the animal's mouth, pharynx, epiglottis, larynx, or trachea. Prior art devices are made rigid, or have complicated internal mechanisms, and therefore can cause trauma to sensitive tissues. Additionally, embodiments of this invention can enable bending of a flexible tip without requiring a traction string or other feature to be within the air flow lumen during intubation. This can also avoid blockage of the air flow lumen with the animal's secretions and thereby permit a more patent passage of air. Incorporation by Reference

All publications disclosed are herein incorporated fully by reference as if separately so incorporated.

INDUSTRIAL APPLICABILITY

The devices and methods of this disclosure will find industrial applicability in medicine, pediatrics, pulmonary disease, emergency medicine, anesthesia, and veterinary medicine.

Claims

1. An endotracheal tube, comprising:

a flexible tube having a flexible tip;

a sidewall surrounding an airflow lumen within said tube; and

a tension string conduit parallel to and lateral from said airflow lumen within said sidewall and having a traction string disposed within said tension string conduit, said traction string attached to a distal portion of said flexible tip; and

a proximal end of said traction string extending through a proximal end of said tension string conduit.

2. The endotracheal tube of Claim 1, said proximal end of said tension string conduit comprising a reinforced portion of sufficient strength to decrease the likelihood of said traction string cutting into said proximal end of said endotracheal tube.

3. The endotracheal tube of any of Claims 1 or 2, said proximal end of the traction string being attached to a pull ring sized to fit loosely on a finger of an operator's hand.

4. The endotracheal tube of any of Claims 1 to 3, said airflow lumen comprising a corrugated material.

5. The endotracheal tube of any of claims 1 to 4, further comprising an inflatable cuff at said endotracheal tube's distal portion.

6. A method for intubating an animal, comprising:

providing an endotracheal tube of any of Claims 1 to 4;

inserting said endotracheal tube into said animal's mouth or nasal passage;

providing tension on said traction ring to bend the distal tip of said endotracheal tube, permitting said distal tip to pass the epiglottis; and

advancing said endotracheal tube past said animal's epiglottis.

7. The method of Claim 6, further comprising:

providing tension on said traction string to permit said distal tip to bend and to pass through the animal's larynx; and

advancing said endotracheal tube past the animal's larynx and into the animal's trachea.

8. The method of any of Claims 6 and 7, further comprising:

severing said traction string at a location proximal to said proximal end of said endotracheal tube.

9. The method of any of Claims 6 to 8, said animal being a human being.

10. The method of any of Claims 6 to 9, where said animal is a neonatal animal.