WO2022175989A2

WO2022175989A2 - Oropharyngeal airway with cuffed esophageal tube

Info

Publication number: WO2022175989A2
Application number: PCT/IR2022/050011
Authority: WO
Inventors: Mehdi REZAEE; Banafsheh MASHAK; Seyed Saeed TAMEHRI ZADEH
Original assignee: Rezaee Mehdi
Priority date: 2021-02-16
Filing date: 2022-02-27
Publication date: 2022-08-25

Abstract

An oropharyngeal airway with cuffed esophageal tube (10) consists of an oral airway (1) and an elongate esophageal tube (3) attached proximally to the oral airway (1) with a distal end (8) for insertion inside mid-esophagus (12). The esophageal lumen (3) is configured for drainage of aspiration contents with a sump port at the distal end (8) of esophageal tube (3) and sump lumen formed the length of the corresponding tube (3). An inflatable esophageal cuff (7) is carried by the esophageal tube body mid-esophagus and an inflation lumen (5) is formed within the esophageal tube (3) and connects the inflatable esophageal cuff (7) to inflatable balloon (6) through which the esophageal cuff is inflated and deflated. Upon inflation of the esophageal cuff, emesis and/or reflux is blocked from passing out of the stomach (13) past the esophageal cuff to protect a patient's airway (11).

Description

Title of Invention Oropharyngeal Airway with Cuffed

Esophageal Tube

FIELD OF THE INVENTION

[001] The field of this invention relates to medical airway and ventilation devices having a cuffed esophageal tube to prevent aspiration due to inevitable regurgitation of gastric contents during mask ventilation in apneic patients.

BACKGROUND OF THE DISCLOSURE

[002] Establishment of airway and ventilation with anesthesia breathing masks is one of the clinical procedures in the field of medicine to deliver oxygen to the lungs in patients with respiratory failure and respiratory arrest; so that it is one of the first care measures in critically ill patients. If this is done quickly, at high quality, and safely, it can prevent the occurrence of various heart and brain complications in critically ill patients and improve the course of treatment. To do this, airway equipment such as anesthesia breathing masks, airways, and endotracheal tubes are used. However, sometimes due to the patient's full stomach and the anatomical condition of the airway, performing this procedure is associated with some problems and complications such as inability to establish the airway, lack of effective lung ventilation, and the entry of air into the stomach and the return of its contents into the lungs. Oxygen mask is designed to carry respiratory oxygen gas from a storage tank to the lungs to deliver enough oxygen to the body tissues. Oxygen mask covers the nose and mouth. One of the dangers and complications when using this is the entry of part of the inhaled air and oxygen into the stomach durinve ventilation with a mask, which may lead to increased intra-abdominal pressure and return of gastric contents to the lungs of patients, so causing many complications including damage to lung tissue. Also, the entry of air into the stomach reduces the entry of air and oxygen delivered to the lungs and leads to a reduction in effective pulmonary ventilation of the patient. Retraction of the tongue can also reduce effective ventilation by blocking the airway. In designing this tool, the oropharyngeal airways platform is used. The basis for the mechanism of this invention is the use of a cuffed blocker that is placed inside the patient's esophagus during ventilation with an airway. Using a cuffed tube channel embedded in the airway, when the airway is placed in the patient's mouth and is directed to the esophagus, this channel is sent into the patient's mouth towards the esophagus. By filling the air cuff of the tube channel inside the esophagus, the gastric contents are prevented from entering the mouth and lungs. Instead, the contents and air inside the stomach are removed during ventilation by connecting the drainage tube to the outlet of the channel. This invention reduces the risk of air entering the stomach and provides more effective and safer ventilation for the patient. This airway is disposable and can be designed in different sizes for different ages. Therefore, the goals presented in the design of this tool are to reduce the risk of aspiration following regurgitation of gastric contents , reduce the risk of air entering the stomach, prevent the tongue from falling back, and increase the safe and more effective ventilation of the patient's lungs.

[003] Today, for the initial establishment of airway and ventilation, equipment such as anesthesia breathing masks and airways of different sizes are used. At higher levels, more advanced devices such as endotracheal tubes and LMA masks are used. The need for skilled individuals; being expensive; reduction of effective ventilation; lack of access everywhere; and lack of safe protection from pulmonary aspiration, especially with respiratory masks, are some of the problems of the current situation in the airway management. In reviewing databases and domestic and foreign patents, examples of similar cases are provided.

[004] Artificial airway devices providing a combination of an airway and an esophageal- obturator are well known in the art. Among the patents teaching such devices are Fortuna, U.S. Patent Application Publication No. U.S. 2004/0020491 A1; O'Neil, U.S. Pat. No. 5,865,176; Bertram, U.S. Pat. No. 5,819,733; Brain, U.S. Pat. No. 5,632,271; Frass, U.S. Pat. No. 5,499,625; Sato, U.S. Pat. No. 5,392,774; Frass, U.S. Pat. No. 4,688,568; and Young, U.S. Pat. No. 4,230,108; Alfery, U.S. Pat. No. 7,013,899.

[005] Each of these patents are generally directed to the concept of isolating the oral airway from a patient's esophagus while providing an esophageal-obturator for allowing communication with the esophagus through a lumen distinct from that providing communication with the larynx. However, each of these devices suffers from one or more shortcomings including: difficulty of placement within a patient; complexity in manufacture and expensive components rendering the devices unnecessarily expensive; lack of reliability in properly seating the devices within a patient; limited access to the patient's pharynx; and difficulty in using the airway for inserting an endotracheal tube. Accordingly, the present invention is directed to overcoming one or more of these problems.

SUMMARY OF THE INVENTION

[006] The oropharyngeal airway, more commonly referred to as the airway, is a device used to keep a patient's mouth open. When the patient is unconscious, the jaw muscles relax and this causes the tongue to loosen and recede, resulting in airway obstruction. This device prevents the tongue from coming back and eliminates the obstruction of the patient's airway. The device is available in a variety of sizes, from infant to adult, and is used for advanced airway management or when manual methods such as Chin lift and Head tilt/Chin lift do not suffice. Ventilation is performed by anesthesia breathing masks to deliver oxygen to the lungs in patients with respiratory failure and respiratory arrest. One of the dangers and complications when doing this is the entry of some air and oxygen into the stomach during ventilation with a mask, which may reduce the patient's effective ventilation, increase intra-abdominal pressure, and return the gastric contents to the patient's lungs, known as aspiration. The respiratory masks used currently have this problem. The solution presented in the design is as follows: Using a cuffed tube channel connected to the oral airway. When the airway is placed in the patient's mouth, the channel is passed towards the patient's esophagus. By filling the cuff of the channel when placed inside the esophageal lumen, the gastric contents are prevented from entering the mouth and lungs, and by connecting the plastic tube to the entrance of the channel, the contents and air inside the stomach can be suctioned and removed during ventilation. This invention reduces the risk of aspiration during mask ventilation specifically in high risk patients and provides a more effective and safer ventilation.

BRIEF DESCRIPTION OF THE DRAWINGS

[007] FIG. 1 is a diagrammatic perspective view of an oropharyngeal airway device with a cuffed esophageal tube;

[008] FIG. 2 is a cross-sectional view of the oropharyngeal airway body;

[009] FIG. 3 is a cross-sectional view of the esophageal tube where esophageal tube cuff is sited; and

[010] FIG. 4 is a side elevational view of the invention shown in operating position against a facial outline.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[011] Referring now to FIG. 1 , an apparatus (10) for providing breathing assist is depicted wherein a combination oropharyngeal airway device (1 ) and esophageal drain tube (3) includes a bi-luminal oropharyngeal airway (1 ) that has a lumen for gas exchange (2) and the other lumen (9) to accommodate the proximal portion of the esophageal drainage tube (3) . The device (10) also includes an inflatable esophageal cuff (7) near a distal end (8) of an esophageal drain tube (3). The esophageal obturator comprises an elongate hollow tube (3) formed of flexible plastics material, an inflatable balloon (6) at proximal end (4), an inflation line (5) and said inflatable esophageal cuff (7). The esophageal tube (3) is open at both ends (4) and (8) respectively. A conduit (2) is formed in said airway body (1 ) for passage of inspiratory gas and venting of a patient's expiratory gas. The oropharyngeal airway (1 ) and esophageal tube (3) are preferably radially robust to not kink during insertion or manipulation.

[012] An inflatable tubular cuff (7) of extensible material is mounted on the external surface of the tube (3) at the end (8) thereof. The external surface of the cuff (7) seals with esophagus below the level of carina following expansion of the esophageal cuff (7).

[013] The esophageal tube (3) attaches to the line of collection bag at its proximal end (4) to allow for drainage of potential aspiration contents.

[014] The pilot balloon (6), which is located on the air injection line (5) of the esophageal tube cuff (7), regulates the pressure and air entering the esophageal tube cuff (7).

[015] In operation, tube (1 ), in which tube (3) is fixed, is inserted through the mouth (14) , laryngeal pharynx (15) and tube (3) is inserted into the mid-esophagus (12) as shown in FIG. 4. Esophageal cuff (7) is inflated through its duct (5) to seal off the tracheal entrance (11 ) from any leakage from stomach (13). Should the recipient become nauseated, vomit freely exits through tube (3), where it is sealed from trachea (11 ), and out end (4) clear of the mouth.

Advantageous Effects of the Invention

THE ADVANTAGES OF THE INVENTION OVER THE PREVIOUS MODELS [016] 1- Simplicity;

[017] 2- More effective and safer pulmonary ventilation in terms of preventing air from entering the stomach (increasing the pressure inside the stomach) and sending the entire ventilated air and oxygen into the patient's lungs;

[018] 3- Preventing the contents of the stomach from returning to the mouth and lungs and the aspiration of the lungs;

[019] 4- Possibility of expelling the gastric contents (reducing pressure inside the gastrointestinal tract) by suctioning or sending the NG tube through the embedded channel; [020] 5- Reducing the existing design costs by increasing efficiency over existing knowledge; [021] 6- Applicability;

[022] 7- Easy to use by medical and non-medical personnel;

[023] 8- Accessibility to pharynx for suctioning of secretions.

Industrial Applicability of the Invention

[024] This invention is used in clinical settings and all inpatient and emergency departments of hospitals, clinics, and operating rooms for therapeutic purposes in different patients, for more effective and safer ventilation with respiratory air.

Claims

[Claim 1 ] An oropharyngeal airway (10) with provision for preventing pulmonary aspiration during mask ventilation comprising: a. An oropharyngeal airway device (1) to establish primary airway in patients with respiratoryfailure and respiratory arrest and prevent airway obstruction due to the retraction of tongue; b. An elongated esophageal tube (3) accommodated proximally inside the said airway body adjacent to air conduit (2) extending past the said airway (1 ) to end in mid-esophagus (12) with inflatable cuff (7) for installation in an esophagus to divert passage of gastric contents away from oral cavity (14) due to possible regurgitation during mask ventilation.

[Claim 2] The oropharyngeal airway (1 ) of the claim 1 , consists of two separate conduits adjacent each other wherein accommodating proximal portion of said esophageal tube lumen (9) and air passage lumen (2).

[Claim 3] An esophageal tube (3) as defined in claim 1 further comprising: a. A main lumen with a proximal (4) and distal end with the proximal portion sited in the said oropharyngeal airway conduit (9) and a distal end (8) for insertion into esophagus (12); b. An inflation balloon (6) connecting the inflation line (5) at the proximal end of the esophageal tube body and configured to permit manual inflation of the esophageal cuff (7); c. an inflation line (5) serially connected to inflation balloon (6) formed within the esophageal tube body (3) and then to the esophageal cuff (7) such that the inflating air supply passing through the inflation line (5) from inflation balloon (6) to the esophageal cuff (7); d. an inflatable esophageal cuff (7) carried by the esophageal tube (3) to mid esophagus (12) and an inflation lumen (5) formed within the esophageal tube body (3) and connecting the inflatable esophageal cuff (7) through which the esophageal cuff is inflated and deflated, wherein upon inflation of said esophageal cuff, emesis and/or reflux is blocked from passing out of the stomach (13) and past the esophageal cuff that is positioned mid-esophagus (12) to protect a patient's airway.