Tracheal Introducer Sheath

Abstract

According to the CDC, the same month (March, 2020) they declared COVD-19 a pandemic, nearly 25% of confirmed COVID-19 hospitalized patients required intubation, or ventilator use. More recently, in the US, during the summer of 2021, child intubations more than quadrupled, when the Delta variant predominated.

As Omicron and additional COVID-19 variants continue to arise globally, there will be an increasing number of sudden spikes in critical illness and respiratory failure. Preparedness with efficacious airway tools that optimize success rate of intubations is critical.

Without the proper tools, intubation procedures take excessive time, and can fail entirely, causing diminished central nervous system oxygenation and potentially permanent neurologic sequelae. Airway adjuncts such as the Tracheal Introducer Sheath (TIS) and Simplified Tracheal Introducer Sheath (STIS) hold immense potential to improve chances of successful intubations.

The TIS is a STIS with an added articulating mechanism, but otherwise is a similar device. For the purposes of further explanation, the TIS refers to both TIS and STIS unless otherwise specified.

TIS is an adjunct medical device for control and guidance of any form of tracheal introducer device through the glottic opening of a patient's airway. This facilitates endotracheal intubation by passage of the endotracheal tube.

An airway introducer is placed within and controlled by the TIS, a mechanically specialized sheath, open at both ends, and covering the distal end of the introducer (where control is most relevant). The TIS acts as a relatively stiff channel, or tunnel, for the introducer to be directed through for smooth travel along courses of varied angles. The proceduralist is able to apply curvature in real-time to the TIS-introducer assemblage based on patient anatomy and other clinical factors. Without the TIS as a channel, an introducer alone can be bent at its tip, but it is limited in its ability to move along that axis as it is being proximally controlled, outside of the patient.

The mechanistic basis for the sheath's guidance capability is based on composition, including, but not limited to, a hollowed shaft of polytetrafluoroethylene (PTFE), with a specific ID/OD (internal diameter/outer diameter) ratio, such that there is sufficient stiffness for the sheath to act as a guide within which the introducer can travel, whilst maintaining appropriate elasticity for malleable control.

The TIS confers additional introducer controllability by minimizing introducer wobble, as introducers can consist of relatively long shaft-like devices, often nearly 60 cm.

Introducer guidance by a TIS, but not the simplified version (STIS) includes a distal articulating tip mechanism, angled as needed while in the tracheal space of a patient, and controlled outside of the patient by moving the proximal sheath through a pull sheath mechanism. To recap, the Simplified Tracheal Introducer Sheath (STIS) lacks this articulating mechanism, but otherwise is a similar device.

Rotatory control in the case of both the TIS and STIS is achieved by rotating the introducer which sits outside the proximal end of the sheath.

A major additional benefit of utilizing a sheath with an introducer is selection of an introducer for placement into a sheath on a case-by-case basis. For example, a smaller, softer tipped introducer could be utilized with a TIS in cases where airway friability or injury is of particular concern; ie a mass with high vascularity and bleeding potential. In another example an introducer with a central canal for oxygenation can be utilized with a TIS when the decision is made to oxygenate through the introducer prior to placement of the endotracheal tube.

Finally, the TIS, with its integration of an articulating mechanism utilizing a pull sheath is without costly electrical components and thus serves as a cost-effective alternative to fiberoptic intubation with a bronchoscope (often utilized among top academic hospitals), which is often cost prohibitive for many rural and community hospitals to stock. As such, the TIS may improve access of lower socioeconomic classes to important technologies in the management of respiratory failure.

Claims

1. Both a tracheal introducer sheath (TIS) device and simplified tracheal introducer sheath device (STIS) are for guiding insertion of a tracheal introducer through the glottic opening of a person's airway, said sheath devices comprising: a hollowed tube of flexible material with (in the case of the TIS but not the STIS) internal wall fiber bundles extended from proximal to distal ends for proximal-to-distal control of an articulating mechanism, through which (with either a TIS or STIS) a tracheal introducer can be easily passed and manually controlled.

2. The said tube of claim 1 in which the hollowed tube is made of polytetrafluoroethylene.

3. The said tube of claim 1 in which the hollowed tube is of sufficient length to provide coverage of distal end of the said tracheal introducer whilst operator handling is over the said hollowed tube but not so long as to limit removal of the said hollowed tube after introducer placement into the trachea.

4. The said tube of claim 1 in which the hollowed tube is a hollowed tube with internal to external diameter ratio creating sufficiently rigid channel for introducer to be guided along the path of the long axis of the said hollowed tube in varied curved forms yet sufficiently flexible to allow operator malleability and shape memory of said hollowed tube.

5. The said tube of claim 1 is with internal diameter that is sufficiently small to allow some contact with said tracheal introducer for vibratory feedback during distal contact with tracheal rings but sufficiently large diameter to allow smooth passage through the said hollowed tube and sufficient stiffness through the body of said hollowed tube.

6. The said internal wall fiber bundles of claim 1 are uniformly diametrically dimensioned and internal to the internal walls of said hollowed tube and throughout the said hollowed tube within which fiber bundles are extended, allowing simultaneous proximal-to-distal control of an articulating mechanism facilitating guidance of said tracheal introducer.

7. A method of guiding insertion of a tracheal introducer through a tracheal introducer sheath beyond the level of the vocal cords for subsequent placement of an endotracheal tube into the airway of a person, the method comprising: providing a tracheal introducer sheath device comprising a hollowed tube; arranging the hollowed tube to comprise polytetrafluoroethylene and to have internal to external diameter ratio creating sufficiently rigid channel for said tracheal introducer to be guided along the path of the long axis of the said hollowed tube in varied curved forms yet sufficiently flexible to allow operator malleability and shape memory of said hollowed tube, inserting the sheath-over-tracheal introducer assemblage into the airway; guiding the said trachea introducer into the trachea through said tracheal introducer sheath and confirmed by vibratory feedback of tracheal rings through said trachea introducer and said tracheal introducer sheath into the operator's hands; positioning the endotracheal tube over the said tracheal introducer and subsequently removing the said tracheal introducer.

8. The method according to claim 7 including arranging said hollowed tube of length allowing grasping but not so long as to limit temporary holding of said tracheal introducer during removal of the said hollowed tube after said introducer placement into the trachea.

9. The method according to claim 7 including arranging said hollowed tube with internal diameter that is sufficiently small to allow some contact along the hollowed tube length with said tracheal introducer for vibratory feedback during distal contact with tracheal rings, but sufficiently large diameter to allow smooth passage through the said hollowed tube and sufficient stiffness through the body of said hollowed tube.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0028] FIG. 1 is a schematic illustration of a human airway with a tracheal introducer sheath device with introducer placed within (also referred to as ‘sheath-over-introducer assemblage’).

[0029] FIG. 2 shows the tracheal introducer sheath device.

[0030] FIG. 3 illustrates an introducer device placed within the sheath of the tracheal introducer sheath.

[0031] FIG. 4 illustrates an axial view of a TIS (but not a BTIS) from proximal and distal ends (above and below, respectively), showing vertebrated succession rigid annuli.

[0032] FIG. 5 is a schematic illustration of a human airway with laryngoscope assisted insertion of a sheath-over-introducer assemblage into the trachea.

[0033] FIG. 6 is a schematic illustration of a human airway with laryngoscope assisted advancement of an introducer through the tracheal introducer sheath device until making contact with tracheal rings.

[0034] FIG. 7 is an illustration of a human airway with correct placement of an introducer in the trachea after a tracheal introducer sheath device has been removed.

[0035] FIG. 8 is a schematic illustration of a human airway with correct placement of an endotracheal tube over an introducer and into the trachea.

[0036] FIG. 9 illustrates the resulting position of the endotracheal tube after removal of an introducer.

DETAILED DESCRIPTION OF THE INVENTION

[0037] FIG. 2 of the drawings illustrates a preferred embodiment of the invention which has been referred to hereinabove as a tracheal introducer sheath (TIS), since the instrument 6 is applicable to assisting passage of a tracheal introducer 10 into the airway, through the oropharynx 9 and past the glottis, for endotracheal intubation. It is to be understood, however, that instrument 6 is not limited to the aforementioned uses. It may, for example, be used for sheathing an introducer 10 of many types such as but not limited to one with a central lumen, for emergent airway oxygenation.

[0038] Instrument 6 comprises a main portion of the body 5, connecting an open-ended sheath (proximal opening 1 and distal opening 4) by a hollowed tube of PTFE, twelve to fifty centimeters long, with varied ID/OD ratios depending on the chosen length.

[0039] As a point of clarification, the length of each individual instrument 6 will generally not be modifiable. A notable functional exception would be if an introducer 10 manufacturer produced an introducer 10 with modifiable length. In this case, if the introducer 10 is placed through the instrument 6, length would be modifiable of the sheath-over-introducer assemblage.

[0040] For an adult instrument 6 of length between twelve and fifty centimeters long, the instrument 6 is to have an internal diameter (ID) ranging between 4 mm and 7 mm with outer diameter (OD) ranging between 6 mm and 11.5 mm. Tube thickness for an adult instrument 6 is to range from 0.5 to 3 mm. One embodiment for an adult size instrument 6 is 20.5 centimeters long with an ID of 6 mm and an OD of 8.4 mm, with a wall thickness of 1.2 mm.

[0041] For the same instrument 6 sized for children, the instrument 6 length is to range from between seven to fifteen centimeters long with IDs ranging between 2.5 mm and 5 mm. Outer diameters will range between 4.5 mm and 7 mm. Tube thickness for a pediatric version of instrument 6 is to range from 0.2 to 2 mm.

[0042] For the TIS but not the STIS, operator controlled articulation of the articulating component 3 occurs by applying a pull force to the proximal portion 2 of the instrument 6, which transmits along an internally installed vertebrate succession of rigid annuli 12 from the proximal portion 2 of the instrument 6 through the body 5 and into the articulating component 3 of the tip and distal opening 4, allowing for proximal operating wires (illustrated in FIG. 4) to effect a smoothly operating graduated bending over a substantial length of the instrument's 6 distal portion, without effect upon intermediate portion of the body 5 and proximal portions 2 of the sheath 6. The vertebrate succession of annuli 12 seen in FIG. 4 is installed internally to the smooth internal surface of the sheath, maintaining smooth passage of an introducer. For those interested in greater detail in the construction of a pull-sheath that maintains a uniformly diametrically dimensioned internal hollow cavity throughout a tube within which fiber bundles are extended, allowing simultaneous proximal-to-distal control of an articulating mechanism, see U.S. Pat. No. 3,913,568.

[0043] The articulating component 3 allows angulation 7 between five and ninety-five degrees.

[0044] The size of the internal diameter of the instrument is constant throughout each individual instrument 6 but can vary between different instruments 6, allowing for passage of different sized introducers 10 when desired by the proceduralist.

[0045] FIG. 3 Illustrates a sheath-over-introducer assemblage, emphasizing both the adjunct nature of the instrument 6, to be utilized with an introducer 10, as well as the 360-degree free rotational movement of an introducer within an instrument 6.

[0046] The first steps of operating a tracheal sheath introducer 6 are illustrated in FIG. 5, during which a proceduralist uses either direct laryngoscopy or video-assisted laryngoscopy to insert a tracheal introducer sheath device 6 with introducer into the airway.

[0047] Once in appropriate proximity to the glottic opening, the tracheal introducer sheath device 6 is held in place, acting as a supporting vehicle through which the introducer is passed and directed towards the tracheal rings 8 (FIG. 6) until a vibratory sensation is felt that reflects tracheal ring 8 resistant forces have been met. Given the need to hold the laryngoscope and the sheath instrument 6, a third person trained in this procedure will advance the introducer 10 at the instruction of the main operator or proceduralist (holding the laryngoscope). Conversely, the proceduralist may ask an appropriately trained assistant to hold the sheath instrument 6 whilst the proceduralist advance the introducer 10.

[0048] At this point, the introducer 10 is held in place while the instrument 6 can be removed (FIG. 7) and an endotracheal tube 11 subsequently slid over the introducer 10 as in FIG. 8. The introducer is removed and endotracheal left in place (FIG. 9) for subsequent securing and mechanical ventilation.