Patent Application
20180099110
The present disclosure generally relates to endotracheal tubes and more particularly relates to endotracheal tubes for oral and nasal intubation.
Endotracheal intubation is a common medical procedure. Endotracheal tubes are used in many different types of procedures. For example, they are used as conduits for airway life support where patients have stopped breathing on their own due to cardiac arrest, respiratory distress, seizures, etc. They are also used during certain surgeries to provide respiratory support to patients while certain surgeries are conducted.
Endotracheal tubes generally comprise a long, somewhat flexible tube with an open distal end that is inserted into a patient's lungs, and a proximal end having an attachment allowing it to couple with a ventilating machine, which provides periodic measured drafts of air to the patient. To ensure that air flow is provided to the patient, an inflatable cuff is disposed on the exterior of the tube, and, after the tube is inserted, the cuff is inflated to provide an air tight seal within the patient's throat. The cuff is generally fed by a separate air pipe, which is referred to as a pilot, that is run along the inside or outside of the endotracheal tube directly to the cuff. An example of a standard prior art endotracheal tube is depicted in
The general procedure for inserting an endotracheal tube is well understood, and illustrated in Prior Art
One type of popular endotracheal tube is typically made of soft biomaterials. The most common biomaterial is polyvinyl chloride with a plasticizer added, but other materials are also used or are in development. Endotracheal tubes made of, for example, a soft polyvinyl chloride, can be difficult to manipulate and insert into a patient's trachea (windpipe). Accordingly, a malleable stylette is often placed into a central lumen of an endotracheal tube to provide more rigidity to the tube and allow the caregiver to have greater control in manipulating the tube into place during insertion. The stylette can be, for example, a malleable rod of plastic, or a plastic coated metal. Normally, the stylette is inserted along the length of the endotracheal tube's central lumen to a point just before the endotracheal tube ends. After the endotracheal tube is inserted into the trachea, the stylette is manually removed.
Another type of endotracheal tube is typically made of a more rigid PVC (polyvinyl chloride). This type of tube has the advantage of not requiring a malleable stylette, and the extra procedures and cost associated therewith. However, the added rigidity can make insertion of the tube more difficult.
To accommodate patients having differently sized trachea, endotracheal tubes are generally provided in different diameters to permit selection of the proper size tube for the patient. To provide the most unobstructed passageway to the lungs of a particular patient, generally, the largest possible diameter tracheal tube acceptable to the patient is utilized. In certain circumstances, where oral intubation is not possible, nasal insertion of the tracheal tube can be required. In both oral and nasal intubation, the edge of the distal end of the endotracheal tube can irritate a patient's mucosal tissue. The hardness of the material of the endotracheal tube factors into the amount of irritation that a patient might experience. Hardness can be measured, for example, using an indentation hardness measurement, such as, for example, Shore durometer.
Proper insertion of an endotracheal tube is vital, as harm to the patient can result if the tube is not inserted far enough, or too far. If the endotracheal tube extends beyond the carina; i.e., the point at which the trachea branches into the lungs, and into the patient's right mainstem bronchus, the bronchial intubation can result in injury, which is generally referred to as Right Mainstem Bronchial Intubation (RMSBI). Alternatively, if the tube is inserted so that the cuff is not entirely past the patient's vocal cords, when the cuff is inflated, the patient's vocal cords can be damaged. Both issues are complicated by endotracheal tubes coming in a number of fixed sizes (both in terms of total length, and the positioning of the cuff relative to the distal end), and patients not falling into a small number of sizes with regards to these dimensions.
Accordingly, there is a need for an endotracheal tube that allows for insertion without irritating a patient's mucosal tissue in the nose, mouth, or the trachea. There is also a need for an endotracheal tube that allows for insertion without damaging the patient's vocal cords, and diminishes the risk of RMSBI.
Accordingly, it is an object of this disclosure to provide an improved endotracheal tube.
Another object of the disclosure is to provide an improved endotracheal tube that minimizes irritation to a patient's mucosal tissue in the nose, mouth and throat.
Another object of the disclosure is to provide an improved endotracheal tube that can be used for both nasal and oral intubation.
Another objection of the disclosure is to provide an improved endotracheal tube that allows for precise positioning of the cuff relative to the patient's vocal cords.
Another object of the disclosure is provide an improved endotracheal tube that reduces the risk of RMSBI.
Another object of the disclosure is to provide an improved endotracheal tube that reduces the risk of irritating a patient's vocal cords.
Another object of the disclosure is to provide an endotracheal tube that incorporates a second inflatable cuff on the distal end of the tube.
Another object of the disclosure is to provide an endotracheal tube with an inflatable cuff that tapers from the end of the cuff disposed towards the distal end of the tube toward the end of the cuff disposed towards the proximal end of the tube.
Other advantages of this disclosure will be clear to a person of ordinary skill in the art. It should be understood, however, that a system or method could practice the disclosure while not achieving all of the enumerated advantages, and that the protected disclosure is defined by the claims.
An improved endotracheal tube is disclosed. The disclosed endotracheal tube comprises a tubular member, which as disclosed herein, can be of any suitable material and dimensions. The tubular member includes a proximal end and a distal end. The proximal end is adapted to couple with a ventilating machine, and may include an adapter as disclosed herein. The distal end includes an opening that is adapted to be disposed past a patient's vocal cords. An inflatable cuff is disposed laterally along the tubular member of the endotracheal tube near the distal end, with the inflatable cuff being adapted to occlude the patient's trachea when inflated so as to prevent air from escaping up the patient's trachea when inflated. The inflatable cuff has a far side, disposed toward the distal end of the tubular member, and a near side, disposed toward the proximal end of the tubular member. The circumference of the exterior surface of the far side is greater than the circumference of the near side. Preferably, the circumference of the near side of the inflatable cuff when inflated is substantially the same as the circumference of the tubular member, while the circumference of the far side must be such as to occlude the trachea of the patient, and prevent air from escaping up the patient's trachea. In addition, a second inflatable cuff is disposed on the distal end of the tubular member. In particular, the second inflatable cuff can be rounded, engulfing the distal tube edge in such manner as to prevent direct contact of the distal end of the endotracheal tube with the patient's tissue, or can be made of a material having a lower Shore hardness score than the material comprising the tubular member.
A method of inserting an endotracheal tube into a patient is also disclosed. In particular, the method comprises the steps of obtaining an endotracheal tube comprising a tubular member having a proximal end and a distal end. The obtained endotracheal tube has a cuff disposed laterally thereon near the distal end of the endotracheal tube. The endotracheal tube has a far end, disposed towards the distal end of the endotracheal tube, and a near end, disposed toward the proximal end of the endotracheal tube. When inflated, the exterior circumference of the far end of the cuff is greater than the exterior circumference of the near end of the cuff. The distal end of the endotracheal tube also has a second inflatable cuff disposed thereon, with the second inflatable cuff being adapted to dull the distal end of the endotracheal tube when inflated. After obtaining the endotracheal tube, a medical practitioner inserts the distal end of the endotracheal tube into a patient, and then positions the tube so that the cuff is properly positioned within the patient. Preferably, the cuff is positioned so that it is placed clear of the patient's vocal cords, although the design of the disclosed inflatable cuff is adapted to minimize any discomfort or harm suffered by the patient if the cuff is placed proximate to the patient's vocal cords. Finally, the medical practitioner secures the endotracheal tube within the patient by, for example, taping the tube in position.
Although the characteristic features of this disclosure will be particularly pointed out in the claims, the invention itself, and the manner in which it may be made and used, may be better understood by referring to the following description taken in connection with the accompanying drawings forming a part hereof, wherein like reference numerals refer to like parts throughout the several views and in which:
Turning to
The endotracheal tube 200 also includes an adapter 216 at the proximal end 214 of the tubular member 210. The adapter 216 can be coupled to a gas source, such as an assisted ventilation device (not pictured), to provide treatment via the endotracheal tube 230. The treatment can be, for example, a mixture of oxygen and air with or without anesthetic, or other substances. The adapter 216 can be internally or externally coupled to the proximal end 214 of the tubular member 210 so that the adapter 216 can be coupled to a ventilating device.
The endotracheal tube 230 and its constituent components can comprise any suitable dimensions. Generally, the dimensions will be sized as appropriate to the patient; i.e., the dimensions of the endotracheal tube 230 will be smaller if the tube is adapted for use on a neonate that if it is adapted for use with an adult male of normal size.
Similarly, the tubular member 210 can be constructed of any suitable material, such as, for example, a flexible medical grade plastic material. Suitable materials include polyvinyl chloride, silicone elastomer, polyurethanes, etc. Similarly, the cuff 220 can also be constructed of any suitable material, such as, for example, a polyurethane.
The disclosed endotracheal tube 200 also incorporates a second cuff 224 disposed at the distal end 212 of the tubular member 210. The second cuff is inflated using a second pilot 235 having an opening 236. The second cuff 224 is adapted to blunt the end of the endotracheal tube 200. When inflated, the second cuff 224 will generally comprise a rounded lip about the distal end 212 of the endotracheal tube 230. The additional softened material comprising the second cuff 224 blunts the distal end 212 of the tubular member 210, so that, for example, when it is inserted into the patient's nose, it will not irritate, or cut the mucosal tissue therein, or at least, it will reduce the irritation of the patient's nasal mucosal tissue. Similarly, rounding the second cuff 224 blunts the distal end 212 of the tubular member 210 so that, if inserted orally, it will minimize the irritation of the mucosal tissue in the patient's trachea. The second cuff 224 may be made of a material that is less hard than the material comprising the tubular member 210. For example, the second cuff 224 can be made of a soft elastomer or polyurethane while the tubular member 210 is made of a semi-rigid polyvinyl chloride.
The second cuff 224 will generally be inflated by an air syringe using the second pilot 236 through an opening on the end of the second pilot 236.
Turning to
The modified cuff 220 of this embodiment offers the substantial embodiment causing less irritation to a patient's vocal cords if the cuff 220 is inflated when disposed at a location that is not clear of the patient's vocal cords. The taper in the cuff's exterior dimensions allows the cuff 220 to be inflated even if the cuff 220 is not entirely clear of the patient's vocal cords because the dimension of the near end 224 of the cuff is narrower than the gap of the client's vocal cords (not shown), or at worst, it will minimally spread the client's vocal cords, rather than the significant spreading and contact that patients suffered through with prior art cuffs.
The foregoing description of the disclosure has been presented for purposes of illustration and description, and is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. The description was selected to best explain the principles of the present teachings and practical application of these principles to enable others skilled in the art to best utilize the disclosure in various embodiments and various modifications as are suited to the particular use contemplated. It is intended that the scope of the disclosure not be limited by the specification, but be defined by the claims set forth below. In addition, although narrow claims may be presented below, it should be recognized that the scope of this invention is much broader than presented by the claim(s). It is intended that broader claims will be submitted in one or more applications that claim the benefit of priority from this application. Insofar as the description above and the accompanying drawings disclose additional subject matter that is not within the scope of the claim or claims below, the additional inventions are not dedicated to the public and the right to file one or more applications to claim such additional inventions is reserved.
