Patent Application
20210322700
Endotracheal tubes are commonly used for airway management in the settings of general anesthesia, critical care, mechanical ventilation, and emergency medicine. An endotracheal tube is a catheter that is inserted into the trachea for the primary purpose of establishing and maintaining a patent airway and to ensure the adequate exchange of oxygen and carbon dioxide. Under certain conditions, an endotracheal tube may need to be replaced or exchanged for continued ventilation of a patient.
For a more complete understanding of the embodiments and the advantages thereof, reference is now made to the following description, in conjunction with the accompanying figures briefly described as follows:
The drawings illustrate only example embodiments and are therefore not to be considered limiting of the scope of the embodiments described herein, as other embodiments are within the scope of this disclosure. The elements and features shown in the drawings are not necessarily drawn to scale, emphasis instead being placed upon clearly illustrating the principles of the embodiments. Additionally, certain dimensions or positionings may be exaggerated to help visually convey certain principles. In the drawings, similar reference numerals between figures designate like or corresponding, but not necessarily the same, elements.
An endotracheal tube (ETT) is a particular type of catheter that is used for airway management in the settings of general anesthesia, critical care, mechanical ventilation, and emergency medicine to establish and maintain a patent airway and to ensure the adequate exchange of oxygen and carbon dioxide. A medical procedure commonly known as intubation involves inserting the ETT (also referred to herein as a tube, catheter, and/or intubation catheter) via a patient's oral or nasal passage to provide a passageway to a lung or lungs for ventilation. Once a patient has been intubated, it may be necessary to replace or exchange the catheter due to improper placement, cuff malfunction, or to change the size or type of ETT. For example, an endobronchial tube used during surgery may need to be exchanged for an endotracheal tube when there is expected to be prolonged ventilation of the patient after surgery.
Most endotracheal tubes have a bevel tip and an opening in a side wall near the tip. Complications can occur during placement of an endotracheal tube such as lacerations, damage to the vocal cords, bleeding, injury to the throat or trachea, or other trauma to the upper airway. This can further complicate the care and recovery of the patient. Replacement of an existing ETT can be particularly difficult due to edema or swelling. Once an ETT is removed, there is a possibility that the airway may close. In such a case, there is a need to keep the airway passage open to replace the tube without causing trauma to the pharynx, larynx, or vocal cords.
When the visualization of the vocal cords is difficult, a stylet or bougie can be inserted into the airway and used as a guide to advance an ETT though the passage to proper placement. A stylet or bougie, such as an Eschmann stylet, is a coated, malleable, elongated cylinder and relatively smaller in diameter as compared to an ETT, which can facilitate passage through the airway. Conventional stylets can be rigid and/or be configured with an angled tip or bend in the stylet. While a stylet or bougie can be used for an initial placement of an ETT, it can also be used as a guide for the replacement of an ETT. For replacement of a tube, the stylet or bougie can be inserted through an existing ETT positioned in the patient's airway, after which the ETT is withdrawn with the stylet or bougie left in place. The replacement ETT is guided over the stylet past the arytenoids and vocal cords and positioned. The stylet or bougie is then removed for the patient to be ventilated through the replaced ETT.
In the context outlined above, the embodiments described herein are directed to a tube changer device configured to aid in the placement or replacement of an endotracheal tube in a patient. The tube changer device is hollow and flexible with a tapered distal end configured to minimize trauma during placement of the ETT. When inserted in an endotracheal tube, the tapered distal dilator portion of the tube changer device is configured to cover the distal wall opening of the endotracheal tube and the blunt tip of the dilator portion extends to or past the bevel tip of the endotracheal tube to provide a blunted end as the endotracheal tube is placed. The tube changer device provides an alternative to conventional stylets used for tube exchanges, including an Eschmann stylet and the like. In some embodiments, the tube changer device can be used to place or replace an ETT. In some embodiments, the tube changer device can be used in conjunction with a stylet to place or replace an ETT. When being used as guide as an alternative or in conjunction with a stylet, the tapered distal dilator portion of the tube changer device can also push away or through a constricted passage at a critical location and a limited airway during the procedure.
In some embodiments, the dilator portion 106 comprises a solid tapered portion configured to provide a blunt tip 107. In some embodiments, the dilator portion 106 can have a substantially prolate spheroid or ovoid shape. The dilator portion 106 can be formed from material firm enough to push away or through a constricted passage, yet soft enough to protect the tissues of the airway. For example, the dilator portion 106 can be formed from polyurethane, polyvinyl chloride, or similar biocompatible materials. In some embodiments, the dilator portion 106 can be made of a sponge-like compressible material that enlarges circumferentially into the available space to a predetermined size limit. In some embodiments, the dilator portion 106 comprises an inflatable portion that can be inflated by a syringe via an inflation lumen.
The device can be sized and configured with measurements to correspond with a range of sizes of endotracheal tubes to be placed. When inserted in the intubation catheter 200 to the distal portion, the dilator portion of the device is configured to cover the distal wall opening of the intubation catheter and the blunt tip of the dilator portion extends to or past the bevel tip of the intubation catheter.
For example, the device can be configured to fit within an intubation catheter or ETT having an internal diameter ranging from about 2.0 mm to about 10.5 mm. As such, the dilator portion 106 of the tube changer device 100 can be sized to slidably fit within the inner diameter of a specified ETT, with a maximum outer diameter ranging from about 2.0 mm to about 10.5 mm. The length of the tube changer device 100 can be substantially longer than a standard ETT to allow the extraction of the tube changer device 100 after placement of the ETT. The length of the tube changer device 110 can range from about 50 cm to about 70 cm, depending on the configuration.
In an example, the tube changer device 100 can be used with both an intubation catheter 200 and a stylet 300. The stylet 300 can be a conventional stylet or bougie, such as an Eschmann stylet. In some embodiments, the stylet 300 can be configured to slide within the lumen 109 of the tube changer 100. As shown in
The tube changer 100 can be used with or without a stylet 300. The tube changer device 100 can be used in place of a stylet or bougie for ETT placement or replacement. The tube changer device 100 can be used in conjunction with a stylet or bougie to aid in opening constricted passages. The tube changer device 100 can be inserted in an ETT to blunt the edges of the distal wall opening 206 and open bevel tip 203 of an ETT to minimize trauma as the tube changer device 100 and ETT 200, together, are advanced over a stylet 300.
For example, the tube changer 100 can be used with only an intubation catheter 200. The tube changer device 100 can be configured to be used in place of a stylet or bougie. The tube changer device 100 can be configured to have a dilator portion 106 with a diameter corresponding to the inner diameter of the replacement tube. The dilator portion 106 of the tube changer device 100 can be guided through an existing ETT to provide a guided passage for a replacement ETT. In this case, the dilator portion 106 can be placed to hold open an airway for a patient at risk of life-threatening loss of airway. While the patient may still be at risk of trauma from the bevel tip of the ETT being guided through a swollen or compromised passage, the larger diameter dilator portion 106 can resist constriction at a critical location and the main lumen 103 can maintain a limited airway during the procedure. When the replacement ETT is advanced to the position of the dilator portion 106, the bevel tip of the ETT is gently guided over the tapered end of the tube changer device 100 and into position. The tube changer device 100 can then be removed from the replacement tube.
This method can be modified to be use the tube changer device 100 in conjunction with a conventional stylet. For example, before inserting the tube changer at step 304, a stylet 300 can be advanced into the existing ETT using a traditional method. The stylet 300 can be used as a guide. Step 304 of inserting a distal end of the tube changer device into the proximal end of the lumen of the first intubation catheter can include threading the tube changer device 100 over the stylet 300. Step 318 of removing the tube changer device from the second intubation catheter can include removing the stylet 300 together with the tube changer device 100.
In another example, after determining that a first intubation catheter placed in an airway of a patient requires replacement, a stylet 300 can be inserted into the first intubation catheter and advanced to a position. While holding the stylet 300 in position, the first intubation catheter can be removed by sliding the first intubation catheter over the stylet 300. Next, by inserting a distal end 102 of the tube changer device 100 into a lumen 209 of a second intubation catheter until a blunt portion 107 of the dilator portion 106 of the tube changer device 100 is positioned substantially aligned with the distal end 202 of the second intubation catheter. Together, the tube changer device 100 within the second intubation catheter can be positioned around a proximal end of the stylet 300, and advanced together. The tube changer device 100 and the second intubation catheter can be guided by the stylet 300 until the blunt portion 107 of the tube changer device 100 reaches a position. While holding the second intubation catheter 200b in position, the tube changer device 100 and stylet 300 can be removed, together, by sliding the tube changer device 100 through the lumen of the second catheter.
Although embodiments have been described herein in detail, the descriptions are by way of example. The features of the embodiments described herein are representative and, in alternative embodiments, certain features and elements may be added or omitted. Additionally, modifications to aspects of the embodiments described herein may be made by those skilled in the art without departing from the spirit and scope of the present invention defined in the following claims, the scope of which are to be accorded the broadest interpretation so as to encompass modifications and equivalent structures.
This application claims the benefit of U.S. Provisional Patent Application No. 63/010,835, filed Apr. 16, 2020, the entire contents of which is hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63010835 | Apr 2020 | US |
