Patent Application
20160101253
This application was prepared with financial support from the Saudia Arabian Cultural Mission, and in consideration therefore the present inventor(s) has granted The Kingdom of Saudi Arabia a non-exclusive right to practice the present invention.
The “background” description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description which may not otherwise qualify as prior art at the time of filing, are neither expressly or impliedly admitted as prior art against the present invention.
When treating a patient, a tracheal tube, for example, endotracheal, endobronchial, nasotracheal, or transtracheal device may be used to control the flow of gases into the trachea of a patient. Often, a seal or cuff between the outside of the tube and the interior wall of the tracheal lumen is required, allowing for the generation of positive intrathoracic pressure distal to the seal and prevention of ingress of solid or liquid matter into the lungs from proximal to the seal.
Endotracheal tubes (ETT) are used in medical procedures, such as endotracheal intubation. Endotracheal intubation is the placement of a flexible tube into the trachea (windpipe) to maintain an open airway. The ETT is inserted from the mouth (orotracheal) or from the nose (nasotracheal). The ETT may be used in both humans and animals where patients have either stopped breathing on their own or are in need of anesthetic gases in their lungs.
Generally, endotracheal tubes are made from soft biomaterials, which are hard to manipulate. A professional caretaker must insert the ETT with great care. An endotracheal tube would normally have a cuff that is used to seal the airway and minimize aspiration.
Conventionally, a single cuff is inflated with air following insertion of the device into the human mid-trachea to achieve an airtight seal of the space between the tube and surrounding tracheal wall. As such the cuffed endotracheal tube has been routinely employed for many decades to prevent upper airway obstruction or to facilitate artificial ventilation of the unconscious or anesthetized patient. However, recent investigations have disclosed several defects in conventional cuffed endotracheal tubes. These defects are, firstly, the failure to prevent secretions from accumulating in the upper trachea. Secondly, all tracheal tubes traverse the delicate structures of the larynx and abrade the vocal cords as a result of to and fro motion of the tube associated with respiration. Thirdly, the effects of intra-cuff sealing pressure upon the ciliated membranes lining the tracheal wall reversibly or permanently injure the cilia and surface membranes of the mid-trachea. The degree of injury is proportional to the magnitude of lateral-wall-cuff pressure in excess of 15 centimeters (cm) of water and to the duration such pressure is applied. Conventionally, the inflatable cuff is placed to rest in the mid-trachea several centimeters below the larynx, where compression of the ciliated endothelium of the trachea causes injury. Conventional endotracheal tube (ETT) cuffs have a single cavity and produce a non-leak seal at pressures which occlude the blood perfusion of the tracheal mucosa and after a period of time produce tissue necrosis.
One problem arising from prevailing practices of tracheal intubation or the insertion of the ETT is the failure of the conventional cuff to prevent secretions from passing through an unprotected space between the vocal cords and the endotracheal tube. The result is an accumulation of a ring of contaminated material in the upper trachea above the inflated cuff which enters the lung when the cuff is deflated at extubation or the removal of the ETT. During intubation this residue or ring of infected secretions may trickle into the larynx and become entrapped above the inflated cuff until subsequent extubation allows the ring of secretions to enter the mid-trachea where injured cilia fail to protect the lung. The normal protective mechanisms by which the cilia carry the secretions upward in the respiratory tree until reflex coughing results in their removal fail to operate.
Embodiments include an endotracheal tube (ETT) having a tracheal tube having a proximal end and a distal end. The ETT also includes a plurality of spaced-apart cuffs disposed around the tracheal tube, the plurality of spaced-apart cuffs being configured to seal a tracheal airway of a patient and to capture tracheal secretions or debris. The ETT further includes at least two pilot balloons connected to the plurality of spaced-apart cuffs, the at least two pilot balloons being configured to inflate and deflate the plurality of spaced-apart cuffs. The ETT also includes at least two injection lumens connected to at least two injection distal ports and being configured to administer fluids to the bronchi of the patient. The ETT further includes at least one evacuation lumen connected to a plurality of evacuation ports, the at least one evacuation lumen being connected to a vacuum source. The plurality of evacuation ports is disposed proximal the plurality of spaced-apart cuffs to remove the captured fluids or debris.
Embodiments also include an endotracheal tube (ETT) having means for intubating a patient via their trachea. The ETT also includes means for sealing a tracheal airway of the patient and for capturing tracheal secretions or debris within the patient. The ETT further includes for inflating and deflating the means for sealing and capturing. The ETT also includes means for administering fluids to the bronchi of the patient. The ETT further includes means for evacuating the captured tracheal secretions or debris. The means for evacuating is disposed proximal the means for capturing tracheal secretions or debris.
The foregoing paragraphs have been provided by way of general introduction, and are not intended to limit the scope of the following claims. The described embodiments, together with further advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.
A more complete appreciation of the disclosure and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:
Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views.
Tracheal tube 105 may be configured to taper from a proximal end 195 (near a patient's mouth/nose) down to the beveled opening 170 (see
As shown in
The first pilot balloon 135 and the second pilot balloon 140 are configured to connect via a channel within the tube wall of the tracheal tube 105 to the first cuff 110 and the second cuff 115, respectively, in order to inflate or deflate each cuff during extubation or intubation. The pilot balloons 135, 140 may also be used to assess the amount of air pressure present in each cuff to prevent damage to the walls or cilia of the trachea during use. In other words, the first cuff 110 and the second cuff 115 may be configured to be inflated (pressurized) symmetrically (equally) via pilot balloons 135, 140, respectively. Such a pressurized configuration may facilitate sealing the airway with the least amount of pressure, thereby further protecting the tracheal wall from tracheal hypoperfusion due to asymmetrical cuff-inflation that could lead to tracheal necrosis. Hypoperfusion may occur if the intra-cuff pressure exceeds the perfusion pressure in a patient.
By having two pilot balloons 130, 135 connected to two cuffs 110, 115, an increase in safety for the ETT 100 may be achieved. For instance, the availability of two cuffs 110, 115 and two intact pilot balloons 130, 135 may eliminate the need to replace the ETT 100 in the case one of the pilot balloons rupturing, or a lumen is accidentally cut which connects the cuffs 110, 115 to the pilot balloons 135, 140. The remaining pilot balloon and cuff may be sufficient protection from aspiration for the patient by still providing the patient with a closed system with the mechanical ventilator and therefore his/her airway would be protected from aspiration. In other words, by having two cuffs 110, 115, the ETT 100 is more securely sealed and held in place within the patient than by a conventional single cuff endotracheal tube configuration, and the two cuffs 110, 115 increase the capture of excess fluids/leakage into the trachea.
The first injection lumen 125 and the second injection lumen 130 may be configured to independently supply a patient with any needed medications or anesthetics while using the ETT 100. The first and second injection lumens 125, 130 are configured to connect via channels within the tube wall of the tracheal tube 105 to the first injection distal port 160 and the second injection distal port 165, respectively. The first and second injection distal ports 160, 165 are disposed proximal to the beveled opening 170. The beveled opening 170 is disposed at the tapered end of the tracheal tube 180. The injection distal ports 160, 165 are disposed at or near the beveled opening 170 of the tracheal tube 105. Each port 160, 165 may be directed towards a bronchus to enable administering chemical fluids, such as a sedation agent or paralytic agent, directly into the right and/or the left bronchus simultaneously or in an independent manner.
The two injection lumens 125, 130 are configured to provide the capability of administering fluids directly to a single bronchus and/or both bronchi of the patient. The evacuating lumen 120 may be disposed at the side of the ETT, connecting the evacuation ports 150, 155 to a vacuum source (not shown) and may be used to remove all fluids collected by the evacuation ports 150, 155.
The evacuation ports 150, 155 may be configured to have a circumferential or 360° opening or port in order to more effectively and efficiently suction or capture any and all tracheal fluids or debris, thereby preventing aspiration of the patient. Such a configuration to suction fluids or debris in a patient's trachea from entering the lungs may prevent medical problems going forward, such as, ventilator-associated pneumonia (VAP) by more than 75%. The evacuation ports 150, 155 may be configured to be of various sizes to provide varying degrees of suction and fluid/debris removal.
The evacuation lumen 120 may be configured to suction fluids or debris while using the ETT 100. The evacuation lumen 120 is configured to connect at one end via an evacuation channel 177 (see
In select embodiments, the cuffs 110, 115 may be configured to form three-dimensional oblong-shapes, such as, strawberry, pear, or heart shaped, for example, having the inward funnel-shaped portions 175, 176. Cuffs 110, 115 may also be configured where the inward portion of the cuff is formed to work as a funnel to facilitate the capture of fluid drainage. First cuff 110 is disposed adjacent to the second cuff 115 in series to act as an additional line of defense from tracheal fluids or debris from entering a patient's lungs. First cuff 110 may be smaller than second cuff 115 to be less intrusive to the patient's larynx 183 (see
The first cuff 110 may further be configured via their funneled shape (175, 176) to facilitate the drainage of any fluids that pass by or through the second cuff 115. First and second cuffs 110, 115 are configured to seal the trachea (airway), thereby minimizing fluid aspiration and securing the ETT 100 in place once inflated by first and second pilot balloons 135, 140. Further, such a configuration may help prevent or reduce incidences of self-extubation, when the ETT 100 is removed on its own due to not being properly secured within the patient.
In some embodiments, the second cuff 115 may be disposed approximately 2 to 3 centimeters (cm) apart from the first cuff 110 to allow for a gap at or near the larynx 183 (see
Endotracheal tubes are typically made from different biomaterials, such as soft, flexible biomaterials. The most common biomaterial used to manufacture endotracheal tubes is polyvinyl chloride with an added plasticizer. Other synthetic materials are also currently used or being developed. In different embodiments different materials may be used to manufacture the ETT 100.
The funnel-shaped portions 175, 176 may be sized to accommodate various amounts of fluid/debris capture. In other words, funnel-shaped portion 175 of first cuff 110 may be smaller than the funnel-shaped portion 176 of the second cuff 115 since the ETT 100 is configured to have cuff 115 to initially capture fluids/debris from the patient's trachea with cuff 110 providing additional protection advantages as discussed above.
In preparation, a medical professional may perform a safety and functionality check of the ETT 100 by first assembling ETT 100 and connecting each lumen (120, 125, 130) to its respective chemical injection input or suction output. Next, the first and second cuffs 110, 115 are inflated and deflated via the first and second pilot balloons 135,140 to test their functionality. Next, the patency of the tracheal tube 105 is confirmed prior to use. Performing this safety and functionality check prior to use may avoid problems during a medical procedure which could cause harm to a patient.
In operation, the ETT 100 may be used by a medical professional by inserting a stylet into the ETT 100 to assist in controlling and moving the ETT 100 during the insertion process within a patient's trachea. Next, the medical professional may apply a lubrication gel onto the lower portion of the ETT 100. Once the ETT 100 preparation is completed, the medical professional prepares the patient 180 for insertion of the ETT 100. The patient 180 must be in a position where the patient 180 lies on their back and their neck is slightly extended with the nose pointing outwards. Next, the medical professional moves the patient's tongue using suitable pieces of equipment to visualize the patient's larynx 183. Now the medical professional inserts the ETT 100 into the larynx 183, such that safety markings (not shown) align next to the vocal cords of the patient 180. Then, the medical professional inflates the first and second cuffs 110, 115, respectively using the pilot balloons 135,140 associated with each cuff. Next, the medical professional ventilates the patient 180 and inspects at the patient's chest to verify the proper placement of the ETT 100 within the trachea. If the placement is improper, adjustments are made by the medical professional. Then, the medical professional secures the ETT 100 in place via securing means 185 and proceeds to connect the evacuating lumen 120, to a vacuum source (not shown). Next, the medical professional may perform a chest x-ray (CXR) as would be understood by those skilled in the art to verify the depth and position of the ETT 100 inside the patient's chest. Then, if the depth is not sufficient, the medical professional adjusts the ETT 100 to adjust its depth in the patient's chest, otherwise, the ETT 100 is placed into operation for patient 180.
As discussed above, in some embodiments, the ETT 100 provides the advantage of a dual line of defense, namely, the first and second cuffs 110, 115, in that, if part of either cuff 110, 115 was to rupture or fail during use, the remaining cuff may continue to perform its protective functions without the need of stopping the medical procedure and replacing the ETT 100.
In some embodiments of this disclosure, the ETT 100 may be configured for use with any suitable patient. A suitable patient may include either humans or animals of different sizes. The ETT 100 may be configured for single or multiple use, depending on the requirements of any particular patient.
In certain embodiments, color-coding is used to minimize or prevent confusion. For example, the pilot balloons 135, 140 may be a specified color, such as light blue and labelled “U” for the upper or second cuff 115 and labelled “L” for the lower or first cuff 110. In another example, the injection lumens 125, 130 may be a specific color, such as green and labelled “R” for the right or first injection lumen 125 and labelled “L” for the left or second injection lumen 130. Further, the evacuation lumen 120 may be a specified color such as yellow for distinction.
The present disclosure includes the advantage of utilizing two cuffs disposed in series which provide an improved configuration which anchors the ETT 100 at positions immediately above and below the larynx 183, thereby preventing bronchial intubation and inadvertent extubation. The present disclosure also includes the advantage of eliminating aspiration by virtue of placing the second cuff 115 immediately above the larynx 183 to keep the upper airway secretions from entering the laryngeal area. After insertion and initial inflation of the cuffs 110, 115, the second cuff 115 rests above the larynx 183 thereby preventing exposure of the larynx 183 and trachea to contamination. By having the inflated cuffs 110, 115 described herein, oral secretions may be captured and removed by a suction catheter connected to the evacuation lumen 120 resulting in protecting both the larynx 183 and trachea during the use of ETT 100 and its subsequent removal from the patient 180. In other words, any secretions or fluids or debris is successfully removed via suction, thereby minimizing or eliminating such secretions or fluids or debris from entering the patient's lungs causing VAP or the like.
Thus, the disclosed dual cuff (110, 115) configuration is superior to conventional single cuffs by (1) providing a positive means of anchoring the cuff between the vocal cords, thereby preventing tube motion, accidental extubation, or further penetration of the ETT 100 into a bronchus, (2) lowering sealing pressure within the trachea and above the larynx 183, thereby reducing the risk of damaging the trachea or larynx 183, and (3) excluding secretions from the larynx 183 or upper trachea.
Thus, the foregoing discussion discloses and describes merely exemplary embodiments of the present invention. As will be understood by those skilled in the art, the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Accordingly, the disclosure of the present invention is intended to be illustrative, but not limiting of the scope of the invention, as well as other claims. The disclosure, including any readily discernible variants of the teachings herein, define, in part, the scope of the foregoing claim terminology such that no inventive subject matter is dedicated to the public.
