Systems and methods for endoscopic airway devices

Abstract

The airway device includes an outer tube and a lens channel partially surrounded by the outer tube. An intraluminal space in the outer tube that is not occupied by the endoscope channel provides a pathway for airflow to the patient. And the esophageal cuff is arranged on the far side of the endoscope body channel. When inflated, the esophageal cuff secures the airway device in the patient's proximal esophagus and assists in preventing gastric regurgitation by mechanically blocking gastric contents from entering the throat. An inflatable balloon is attached at an anterior surface of the scope channel between the esophageal cuff and the distal opening of the outer tube. When inflated, the balloon forms a tubular loop that urges the epiglottis and / or other soft tissue towards the wall of the lower pharynx to create an unobstructed air passage into the patient's trachea.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This PCT application claims priority to U.S. patent application No. 17 / 991,827, entitled “System and Method for an Endoscopic Airway Device,” filed in the U.S. Patent Office on November 21, 2022, the entire contents of which are incorporated herein by reference as if fully set forth below and for all applicable purposes. Technical Field

[0003] The present application relates to systems and methods for airway devices, and more particularly to airway devices configured for upper gastrointestinal endoscopy or upper gastrointestinal endoscopic surgery. Background Art

[0004] An estimated 31 million upper gastrointestinal (UGI) endoscopies and UGI endoscopic procedures (hereafter referred to as "gastroscopy") are performed annually in the United States. UGI endoscopy is performed to examine the esophagus, stomach, and first portion of the small intestine (called the duodenum). UGI endoscopic procedures include endoscopic retrograde cholangiopancreatography (ERCP), endoscopic banding, percutaneous endoscopic gastrectomy (PEG), and transesophageal echocardiography (TEE). These procedures present unique airway challenges with profound clinical consequences for several reasons.

[0005] First, a gastroscope, which is 8 to 13 mm in diameter, takes up a significant portion of the patient's airway space when inserted. The result is a decrease in the total space available for the patient to breathe. This encroachment of the endoscope on the airway puts the patient at high risk for airway compromise. In fact, one of the most common complications associated with gastroscopy is hypoxemia, and the reduction in available airway space caused by endoscopes with large cross-sectional areas is a major contributing factor. According to the American Association of Nurse Anesthetists (AANA) Foundation's closed claims database, respiratory events are the largest cause of adverse outcomes. The American Society of Anesthesiologists (ASA) Closed Claims Database reports that the most common inadequate sedation claim is for inadequate oxygenation / ventilation, and over 80% of claims of this nature result in brain injury or death.

[0006] Secondly, the presence of the endoscope in the throat limits the anesthesiologist's ability to access the airway when and if necessary. During an endoscopy, if a patient experiences clinically significant oxygen desaturation and respiratory insufficiency, the anesthesiologist has only a few minutes to correct the respiratory status before the patient suffers permanent damage to the brain and other organs of the body. Having to handle the endoscope makes it more difficult for the anesthesiologist to quickly restore much-needed respiratory stability.

[0007] Third, most gastroscopy procedures are performed under deep sedation to minimize patient discomfort and suppress vomiting, coughing, and laryngeal spasm reflexes. Due to these benefits, the popularity of deep sedation is increasing. However, this form of anesthesia carries very real risks. One consequence of deep sedation is the loss of pharyngeal and laryngeal muscle tone and the suppression of respiratory drive, which lead to upper airway obstruction and apnea, respectively. Both of these effects of deep sedation can lead to hypoxia or damage to the brain and other organs. The general trend of increasing comorbidities in the US population (such as aging, sleep apnea, and obesity) can further exacerbate airway obstruction.

[0008] Fourth, the reduction of protective airway reflexes and the tone of the upper and lower esophageal sphincters, the patient's supine position during gastroscopy, the insufflation of air or fluids, and irritation of the larynx during gastroscopy may contribute to the reflux and aspiration of gastric contents. Aspiration can cause minor symptoms, such as coughing, which can lead to premature termination of the procedure. However, aspiration often causes more troublesome problems, such as laryngospasm, bronchospasm, and pneumonia, all of which can be potentially fatal.

[0009] Fifth, during a gastroscopy, the airway is completely unprotected. There is no barrier to gastric reflux, rinsing fluids, or patient secretions leaking into the airway. This is exacerbated by the patient's reduced ability to clear fluids and secretions once they enter the airway.

[0010] Currently available oral and nasal airway devices are insufficient to effectively address the aforementioned difficulties associated with gastroscopy. Therefore, there is an urgent need for an airway device that can efficiently and effectively relieve obstruction from redundant tissue in the pharynx and maintain airway patency. There is also an urgent need for an airway device that can be connected to an oxygen delivery device and a ventilator. In addition, there is a need for an airway device that allows the digestive tract to be separated from the airway to prevent gastric contents from entering the airway. And, most importantly, there is an urgent need for an airway device that is easy to introduce into the patient's larynx, as the ease and speed of establishing upper airway patency are major determinants of patient outcomes. Such a device will contribute to better patient outcomes and patient satisfaction. In addition, it will help reduce litigation risk for providers and hospital systems, as inadequate ventilation and oxygenation are a significant source of medical malpractice lawsuits. Summary of the Invention

[0011] In one aspect, a medical device includes a scope channel configured for insertion into a patient's larynx and an inflatable balloon attached to a front surface of a distal portion of the scope channel, wherein, in an inflated state, the balloon forms a ring extending outward from the front surface of the scope channel.

[0012] In another aspect, a method for inserting an airway device includes inserting a gastroscope through a scope channel, introducing the gastroscope into a patient and advancing the gastroscope into the patient's proximal esophagus, and inserting the airway device into the patient's larynx and proximal esophagus until the tip of the scope channel is visible to the gastroscope. The method also includes using an inflatable balloon on the scope channel to push soft tissue in the patient's hypopharynx and / or epiglottis toward the peripheral wall of the hypopharynx.

[0013] In another aspect, a medical device includes a scope channel configured for insertion into a patient's larynx and an outer tube that surrounds a portion of the scope channel and defines an intraluminal space between an inner wall of the outer tube and an outer wall of the scope channel. The medical device also includes an inflatable balloon attached to a front surface of a distal portion of the scope channel, wherein, in an inflated state, the balloon forms a ring extending outward from the front surface of the scope channel, and an inflatable cuff attached to the scope channel distally relative to the balloon, wherein the scope channel is positioned within an inner aperture formed by the inflatable cuff, and wherein, when inflated, the inflatable cuff radially expands from the scope channel.

[0014] In one or more of the above aspects, the inflatable airbag includes a rear portion and a front portion, the rear portion being attached to the front surface of the distal portion of the scope channel, wherein when the inflatable airbag is in an inflated state, the front portion extends outward from the front surface of the scope channel at an approach angle.

[0015] In one or more of the above aspects, the anterior portion of the inflatable balloon is configured to retract soft tissue and / or the epiglottis from the center to the periphery of the hypopharynx of the patient's larynx when the inflatable balloon is in the inflated state.

[0016] In one or more of the above aspects, the scope channel further comprises an airbag base. The airbag base comprises a rear surface coupled to a front surface of a distal portion of the scope channel and a front surface coupled to a rear portion of the inflatable airbag.

[0017] In one or more of the above aspects, the air bag mount further includes a recess across a front surface of the air bag mount, the recess configured to retain a front portion of the inflated air bag along a transverse axis of the air bag mount. The air bag mount further includes a cover attached to a distal portion of the air bag mount by a spring hinge, wherein the cover extends through the inner bore of the inflated air bag and covers a top portion of the recess in a closed position.

[0018] In one or more of the above aspects, the recess of the air bag mount is configured to retain the front and rear portions of the air bag in a deflated state, and wherein the hinged cover is configured to cover the recess including the air bag in the deflated state.

[0019] In one or more of the above aspects, the inflatable cuff is attached to the scope channel distally relative to the airbag, wherein the scope channel is positioned within an inner hole formed by the inflatable cuff, and wherein when inflated, the inflatable cuff expands radially from the scope channel.

[0020] In one or more of the above aspects, the inflatable cuff is configured to create a seal with a wall of the proximal esophagus when inflated.

[0021] In one or more of the above aspects, the first inflation lumen is coupled to the inflatable balloon, and the second inflation lumen is coupled to the inflatable cuff.

[0022] In one or more of the above aspects, the pressure regulator is configured to regulate a first pressure in the inflatable balloon using the first inflation lumen and to regulate a second pressure in the inflatable cuff using the second inflation lumen.

[0023] In one or more of the above aspects, the outer tube forms an internal space that accommodates at least a portion of the scope channel that is proximal to the inflatable airbag and distal to the proximal opening of the scope channel, wherein the inner wall of the outer tube and the outer wall of the scope channel form an intraluminal space.

[0024] In one or more of the above aspects, the adapter includes a first proximal port that forms a seal around the proximal opening of the scope channel and a distal port that forms a seal around the outer tube. The adapter also includes a second proximal port and a sealed air flow path extending from the second proximal port to the intraluminal space.

[0025] In one or more of the above aspects, a method includes creating a seal between a scope channel and a wall of the proximal esophagus using an airway device.

[0026] In one or more of the above aspects, a method includes inserting a gastroscope through a scope channel, introducing the gastroscope into a patient and advancing the gastroscope into the patient's proximal esophagus; and inserting an airway device into the patient's throat until the tip of the scope channel is visible to the gastroscope.

[0027] In one or more of the above aspects, a method includes inflating a cuff attached to a distal portion of a scope channel, wherein when inflated, the inflatable cuff radially expands from the scope channel and forms a seal between the scope channel and a wall of the proximal esophagus.

[0028] In one or more of the above aspects, the method includes inflating a balloon attached to the front surface of the distal portion of the scope channel, wherein, in the inflated state, the balloon forms a ring extending outward from the front surface of the scope channel and pushes soft tissue and / or epiglottis in the patient's hypopharynx toward the peripheral wall of the hypopharynx.

[0029] In one or more of the above aspects, a method includes adjusting a first pressure in a balloon using a first inflation lumen and adjusting a second pressure in a cuff using a second inflation lumen.

[0030] In one or more of the above aspects, a method includes introducing oxygenated air into a sealed air flow path extending into an intraluminal space between an inner wall of an outer tube and an outer wall of a scope channel.

[0031] In one or more of the above aspects, the airbag base includes a rear surface coupled to the front surface of the distal portion of the scope channel; a front surface coupled to the rear portion of the inflatable airbag; and a recess on the front surface of the airbag base, wherein the inflatable airbag in a deflated state is folded into the recess. The airbag housing may further include a cover attached to the distal portion of the front surface of the airbag base via a spring hinge, wherein the cover extends along a top of the recess and covers the inflatable airbag in a deflated state that is folded into the recess.

[0032] In one or more of the above aspects, the inflatable airbag exerts a force on a proximal portion of the cover of the airbag base during inflation to open the cover, and wherein when the inflatable airbag is inflated, the cover returns to a closed position through the inner hole of the inflatable airbag and covers the top of the recess by the recoil action of the spring hinge. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 A perspective view illustrating an embodiment of an airway device is shown.

[0034] Figure 2 An embodiment of an airway device positioned in vivo within the larynx of a patient is illustrated.

[0035] Figure 3 An embodiment illustrating a longitudinal cross-sectional view of an airway device

[0036] Figure 4 An embodiment of a circumferential cross-sectional view of an airway device is illustrated.

[0037] Figure 5 Another embodiment of a circumferential cross-section of an airway device is illustrated.

[0038] Figure 6A and Figure 6BAn embodiment of the distal portion of the scope channel 102 is illustrated in greater detail.

[0039] Figure 7A 、 Figure 7B and Figure 7C An embodiment of an air bag mount is illustrated with the air bag in a deflated state.

[0040] Figure 8A 、 Figure 8B and Figure 8C An embodiment of the air bag base is illustrated with the air bag in a semi-inflated state.

[0041] Figure 9 A schematic block diagram illustrating an exemplary embodiment of a pressure regulator and control system is shown.

[0042] Figure 10A 、 Figure 10B 、 Figure 10C and Figure 10D Embodiments of methods of airway devices during gastroscopic procedures are illustrated.

[0043] Figure 11 Embodiments of a method of an airway device for delivering oxygenated air to a patient during a gastroscopy procedure are illustrated. DETAILED DESCRIPTION

[0044] The words "exemplary" or "embodiment" are used herein to mean "serving as an example, instance, or illustration." Any embodiment or aspect described herein as "exemplary" or "embodiment" is not necessarily to be construed as preferred or advantageous over other aspects of the invention. Likewise, the term "aspect" does not require that all aspects of the disclosure include the discussed feature, advantage, or mode of operation.

[0045] Embodiments will now be described in detail with reference to the accompanying drawings. In the following description, numerous specific details are set forth to provide a thorough understanding of the aspects described herein. However, it will be apparent to those skilled in the art that these and other aspects may be practiced without some or all of these specific details. In addition, well-known steps in the methods of the process may be omitted from the flowcharts presented herein to avoid obscuring aspects of the present disclosure. Similarly, well-known components in the devices may be omitted from the drawings and descriptions presented herein to avoid obscuring aspects of the present disclosure.

[0046] Disclosed herein are systems, methods, and devices for maintaining a reliable, safe airway during medical procedures involving an esophageal catheter, such as gastroscopic procedures, performed under sedation. An endoscopic airway device includes an outer tube having a proximal end and a distal end. A scope channel is disposed within the outer tube and secured to the inner wall of the outer tube. The scope channel is a flexible tubular structure configured to allow passage of a gastroscope. Additional space in the outer tube, i.e., intraluminal space not occupied by the scope channel, provides a path for air flow to the patient.

[0047] The distal end of the scope channel extends outward from the distal opening of the outer tube. An inflatable esophageal cuff is located at the distal end of the scope channel. When inflated, the esophageal cuff ensures the airway device remains in the patient's hypopharynx / proximal esophagus and helps prevent gastric reflux by mechanically blocking the backflow of gastric contents into the pharynx and larynx. The inflatable balloon is attached to the anterior surface of the scope channel between the esophageal cuff and the distal opening of the outer tube. When inflated, the balloon forms a circular or elliptical ring with an inner hole in the center. The inflated balloon pushes against the soft tissues and epiglottis in the hypopharynx from the center toward the peripheral wall of the hypopharynx, the area between the oropharynx at the level of the hyoid bone and the esophagus at the lower end of the cricoid cartilage. The space created in the center of the inflated balloon provides an unobstructed airway into the patient's trachea. Thus, the balloon effectively clears the hypopharynx adjacent to the laryngeal opening, providing a clear airway.

[0048] Figure 1 A perspective view of an embodiment of an airway device 100 is illustrated. The airway device 100 is a medical device configured for insertion into a patient's larynx. In one embodiment, the airway device includes a body channel 102 and an outer tube 130. The outer tube 130 is an oval, hollow tube configured to fit within the patient's larynx and hypopharynx. The outer tube 130 forms an interior space that accommodates at least a portion of the body channel 102. The outer tube 130 can be designed to be semi-rigid / semi-flexible and can be made of a material that meets certain rigidity / flexibility requirements, such as, but not limited to, the ability to bend to effectively fit within the patient's larynx. In certain embodiments, the outer tube 130 can include a polymer tube, such as, but not limited to, polyvinyl chloride (PVC), silicone, and / or other thermoplastic materials. In embodiments, portions of the semi-rigid portion of the outer tube 130 can include a corrugated configuration to allow for additional flexibility. The outer tube 130 is sized and shaped to fit within the patient's larynx. The interior space in outer tube 130 (ie, the intraluminal space not occupied by scope channel 102) provides a pathway for air flow to the patient.

[0049] The scope channel 102 is a flexible tubular structure forming a circular or oval hollow channel. Similar to the outer tube 130, the scope channel 102 can be designed to be semi-rigid / semi-flexible and can be made of a material that includes the desired rigidity / flexibility requirements (such as, but not limited to, bending to effectively fit within the patient's throat). In certain embodiments, the scope channel 102 can include a polymer tubing such as, but not limited to, polyvinyl chloride (PVC), silicone, and / or other thermoplastic materials. In embodiments, portions of the semi-rigid portion of the scope channel 102 can include a corrugated configuration to provide additional flexibility.

[0050] The interior space of the scope channel 102 is configured to accommodate at least a gastroscope during a medical procedure. At the proximal end of the scope channel 102, the outer rear surface of the scope channel 102 is fixed to the inner wall of the outer tube 130. At the distal end, the scope channel 102 protrudes from the distal opening 132 of the outer tube 130 and extends outward. At least this distal portion of the scope channel 102 is shaped and sized to fit within the patient's hypopharynx and esophagus.

[0051] In an embodiment, the outer portion 114 of the scope channel 102, which protrudes from the outer tube 130, includes an inflatable cuff 110. The inflatable cuff 110 is a donut-shaped ring that forms an inner bore, wherein the scope channel 102 is mounted within the inner bore. The cuff 110 can include a low-volume high-pressure (LVHP) cuff or a high-volume low-pressure (HVLP) cuff. The first type, the LVHP cuff, is made of a harder, relatively inelastic material. Due to its inherent stiffness, a higher level of pressure (50 cmH2O to 100 cmH2O) is required to inflate the LVHP cuff. The second type of cuff, the HVLP cuff, is composed of a more elastic, compliant material that inflates at a lower pressure. To compensate for the lower pressure characteristics and create a seal against the tracheal wall, the diameter of the HVLP cuff when fully inflated is typically 1.5 to 2 times the diameter of the trachea. The inflatable cuff may also include a combination of an LVHP-type cuff and an HVLP-type cuff, as described in U.S. patent application Ser. No. 17 / 848,273, filed on June 23, 2022, entitled “SYSTEM AND METHOD FOR AN ENDOTRACHEAL TUBE CUFFASSEMBLY,” which is incorporated herein by reference.

[0052] The cuff 110 is deflated when the airway device 100 is introduced into the patient and is inflated after the cuff 110 is positioned in the patient's esophagus. When inflated, the cuff 110 creates a seal against the esophageal wall and serves two important functions: 1. securely holds the airway device 100 in the patient's hypopharynx / proximal esophagus; and 2. prevents gastric reflux by mechanically preventing gastric contents from flowing back into the larynx.

[0053] In an embodiment, the outer portion 114 of the scope channel 102, which protrudes from the outer tube 130, further includes an inflatable balloon 120. The inflatable balloon 120 is positioned proximally relative to the inflatable cuff 110 and distally relative to the outer tube 130. In an inflated state, the balloon 120 expands into a circular or oval shape having an inner aperture. The anterior portion of the inflated balloon 120 extends outward from the scope channel 102. The posterior portion of the ring is coupled to the anterior surface of the outer portion 114 of the scope channel 102 along its transverse axis (e.g., along a circumferential line of the scope channel 102).

[0054] In an embodiment, the balloon 120 is attached to the scope channel 102 via a balloon mount 104. The balloon mount 104 can be secured to the front surface of the outer portion 114 of the scope channel 102 between the cuff 110 and the distal opening 132 of the outer tube 130. The rear surface of the balloon mount 104 is configured to at least partially surround the outer surface of the scope channel 102. The front surface of the balloon mount 104 is oval and forms a recess that is attached to the lower surface of the balloon 120. The balloon 120 spans the recess of the balloon mount 104 laterally.

[0055] The balloon cover 106 spans longitudinally across the top of the recess, with its distal end secured by attachment to the balloon base 104 and its proximal end remaining unattached. The cover 106 covers the deflated balloon 120, providing a smoother surface for the airway device 100. This smoother surface facilitates the insertion of the airway device 100 by allowing it to slide more easily into the patient's larynx. Without this smooth surface, an inflated balloon, even when deflated, would create an irregular surface that could catch on the upper edge of the epiglottis, causing it to fold downward and block the entrance to the larynx, potentially with disastrous consequences. In contrast, the deflated balloon 120 is tucked into the recess of the balloon base 104 and covered by the cover 106, creating a smooth surface. This smooth surface of the balloon base 104 facilitates insertion of the airway device 100.

[0056] The cover 106 can be comprised of a material with high elasticity, i.e., a material that bends easily and has a strong tendency to return to its original state. Thus, when the airbag 120 is inflated, the cover 106 bends upward due to its low bending stiffness, allowing the inflated airbag 120 to deploy from beneath the airbag cover 106. When the airbag 120 is inflated, the airbag cover 106 returns to its original position to cover the recessed space and the rear portion of the airbag 120, thereby allowing for an unobstructed air passage without interference from the airbag cover 106. In another embodiment, a spring hinge can be attached to the airbag cover 106 and the airbag base 104 to maintain the airbag cover 106 in the closed position.

[0057] At the proximal section of the airway device 100, a flange 140 extends from the side of the outer tube 130. The flange 140 is configured for external placement on a patient's mouth to stabilize the airway device 100. The flange 140 includes slits or holes 142a to 142d on opposite ends for attaching a cloth strap or webbing that is wrapped around the patient's neck.

[0058] On the proximal side of the airway device 100, the scope channel 102 extends outwardly from the outer tube 130. In embodiments, an airway adapter 150 is attached to this proximal side of the airway device 100. The airway adapter 150 includes a first proximal port 156 that forms a seal around the proximal opening of the scope channel 102 extending from the outer tube 130. The distal port of the airway adapter 150 is configured to sealingly fit over the outer tube 130 including the scope channel 102. An endoscope or other instrument can then be placed down the scope channel 102 and into the esophagus.

[0059] Airway adapter 150 also includes a second proximal port 154 that forms a seal with the intraluminal space between scope channel 102 and outer tube 130. Proximal port 154 is configured and sized for connection to a ventilator or oxygen delivery tube. The ventilator or oxygen delivery tube can then provide air flow into the intraluminal space between scope channel 102 and outer tube 130. Airway adapter 150 is optional. When the patient's respiratory status is satisfactory on room air and assisted breathing is not required, airway adapter 150 can be used without airway device 100.

[0060] A first inflation lumen 112 and a second inflation lumen 122 extend outwardly from the proximal opening of the scope channel 102. The first inflation lumen 112 is fluidly coupled to the balloon 120 for inflation and deflation, and the second inflation lumen 122 is fluidly coupled to the cuff 110 for inflation and deflation. Indicator balloons 124 and 126 provide pressure and inflation indications for the balloon 120 and cuff 110, respectively.

[0061] In use, the airway device 100 provides a method for clearing soft tissue from a patient's larynx and hypopharynx. The airway device 100 is inserted into the patient and then positioned so that the balloon 120 is adjacent to the patient's larynx and hypopharynx. When so positioned, the balloon 120 inflates and expands in a radial direction to ultimately form a circular or elliptical ring with an inner hole formed in the center. This radial expansion of the inflatable balloon 120 pushes the soft tissue typically present in the hypopharyngeal cavity adjacent to the laryngeal opening toward the periphery of the hypopharynx, providing an unobstructed air passage into the patient's trachea.

[0062] Figure 2An embodiment of the airway device 100 is illustrated positioned in vivo within the larynx of a patient 200. Although a human patient 200 is shown herein, the airway device 100 may be used with other animals as well.

[0063] The airway device 100 is configured to extend from the patient's oral cavity into the hypopharynx 210 and into the proximal portion of the esophagus 202 of the patient 200. The cuff 110 is shown in an inflated state and is configured, for example, in size, shape, and pressure, to provide a seal against the esophageal wall 216. The presence of the cuff 110 at the distal end of the scope channel 102 prevents stomach contents or irrigation fluid from spilling into the trachea 204. Furthermore, the cuff 110 eliminates the possibility of inadvertently spilling irrigation fluid and foreign matter falling into the airway during insertion or removal of the endoscope.

[0064] The airway device 100 is also positioned so that the balloon 120 is adjacent to the patient's larynx and hypopharynx 210. When so positioned, the balloon 120 is inflated and assumes a rigid, circular or elliptical ring shape. The inflatable balloon 120 expands in a radial direction to ultimately form a circular or elliptical ring with an inner hole in the middle. This radial expansion of the inflatable balloon 120 pushes the soft tissue (including the epiglottis 208) that is typically present in the hypopharyngeal cavity adjacent to the laryngeal opening toward the periphery of the hypopharynx to provide an unobstructed air passage into the trachea 204 of the patient 200. The inner hole created in the middle of the inflated balloon 120 provides an unobstructed air passage into the patient's trachea.

[0065] Figures 3 to 5 Various cross-sectional views of an embodiment of an airway device 100 are illustrated. Although the figures show various dimensions and measurements, these dimensions and measurements are exemplary and may vary, for example, depending on the patient, application, or other factors. Figure 3 , illustrates a longitudinal cross-sectional view of an airway device 100, which includes a scope channel 102, an outer tube 130, and an airway adapter 150. At the scope channel 102, a first inflation lumen 112 and a second inflation lumen 122 extend from a proximal opening of the scope channel 102 through a hollow space formed in the front wall 302 of the scope channel 103 to the airbag 120 and the cuff 110, respectively. Since the cuff 110 extends radially around the scope channel 102, the first lumen 122, which is fluidically coupled to the cuff 110, can alternatively be positioned within the rear wall or side wall of the scope channel.

[0066] The outer tube 130 surrounds only the portion of the scope channel 102 that is proximal to the inflatable balloon 120 and distal to the proximal opening 152 of the scope channel 102. As seen in this cross-sectional view, proximally from the flange 140, a proximal portion 330 of the scope channel 102 extends outward from the proximal opening of the outer tube 130. The airway adapter 150 includes a proximal top surface 312 that forms a proximal opening or orifice configured to sealingly fit around the proximal orifice 152 of the scope channel 102. A distal wall 314 of the airway adapter 150 forms a seal around the outer tube 130. Between the proximal and distal walls 312, 314, the airway adapter 150 forms a sealed airflow passageway or channel 310 that extends from the proximal orifice 154 to the intraluminal space 320 between the inner wall of the outer tube 130 and the outer wall of the scope channel 102. The tubular mouth 154 formed by the airway adapter 150 is constructed and sized for connection to a ventilator or oxygen delivery tube. Thus, the ventilator or oxygen delivery tube can insert oxygenated air into the intraluminal space 320. The oxygenated air will flow through the intraluminal space 320 and into the clean airway in the patient's hypopharynx.

[0067] When inflated, the balloon 120 is positioned laterally and extends outward from the base 104 and is angled proximally from the scope channel 102 and / or the top surface of the base 104. Specifically, the balloon 120 is angled at an approach angle from perpendicular to the front surface of the scope channel 102. For example, the approach angle may be in the range of 0 to 30 degrees, or in the range of 5 to 25 degrees, or in the range of 10 to 20 degrees. This approach angle is exemplary and may vary depending on factors such as the placement of the balloon 120 on the scope channel 102, the extension of the balloon 120 from the scope channel 102, the size of the patient's larynx, and the like. Those skilled in the art will appreciate from this disclosure that the size of the balloon 120 and the angular positioning of the balloon 120 are configured to push the soft tissue within the hypopharyngeal cavity (including the epiglottis 208) adjacent to the laryngeal opening against the circumferential wall of the hypopharynx to provide an unobstructed air passage into the patient's trachea.

[0068] In one example, the outer tube 130 has a length L of 150 mm to 250 mm. OT and a thickness of 1 mm to 3 mm. The airbag base 104 has an exemplary length of 30 mm to 60 mm. The recess or compartment within the airbag base 104 has an exemplary height of 2 mm to 4 mm and an exemplary length of 2 cm to 3 cm.

[0069] Figure 4 Illustrated along Figure 3 1 is a circumferential cross-sectional view of the airway device 100 taken along line H-H shown in FIG. Figure 4As shown, the circumference of the scope channel 102 is smaller than the circumference of the outer tube 130, so that the scope channel 102 can fit internally to the outer tube 130 while also leaving an intraluminal space 320 between the scope channel 102 and the outer tube 130. The outer rear wall of the scope channel 102 is attached to or integrally formed with the inner rear wall of the outer tube 130 at line 400. Thus, the intraluminal space 320 is larger on the front side of the airway device 100.

[0070] Within the front wall 302 of the scope channel 102, the first and second inflation lumens 112, 122 extend through a hollow tube 402 formed in the front wall 302 of the scope channel 102. In alternative embodiments, the tube 402 may be attached to the front inner wall or the front outer wall of the scope channel 102.

[0071] In one example, the outer tube 130 may have a vertical diameter VD greater than OT Horizontal diameter HD OT For example, the outer wall of the outer tube 130 may have a horizontal diameter HD in the range of 25 to 23 mm or approximately 24 mm. OT－EW , and the outer wall of the outer tube 130 may have a vertical diameter VD in the range of 22 to 23 mm or approximately 21 mm OT－EW The inner wall of the outer tube 130 may have a horizontal diameter HD in the range of 21 to 19 mm or approximately 20 mm. OT-IW , and the inner wall of the outer tube 130 may have a vertical diameter VD in the range of 18 to 16 mm or about 17 mm OT-IW Thus, the outer tube 130 is more oval, with its horizontal diameter being greater than its vertical diameter. The wall thickness of the outer tube 130 is in the range of 3 to 5 mm, or approximately 4 mm.

[0072] In this example, the mirror body channel 102 is circular with an outer wall diameter D SC-OW In order to accommodate the hollow tube 402 in the front wall 302 of the mirror body channel 102, the thickness of the front wall 302 can be greater than the thickness of the rear wall 404 of the mirror body channel 102. For example, the inner wall diameter D SC-IW1 The front wall can be 12 mm, and the inner wall diameter D SC-IW2 At other parts it may be 13 mm.

[0073] The balloon 120 is a circular ring in this example, but can be an elliptical ring. The tubular ring of the balloon 120 creates an inner hole 410. The rear portion 414 of the balloon 120 is attached to the balloon base 104, and the front portion 412 of the balloon 120 extends outward from the mirror channel 102. An exemplary diameter of the outer circumference of the balloon 120 is approximately 10 mm to 20 mm. An exemplary diameter of the inner circumference of the balloon 120 is approximately 5 mm to 10 mm. These dimensions and configurations of the balloon 120 are designed to enable the balloon 120 to reach the soft tissue and / or epiglottis and push the soft tissue and / or epiglottis to the periphery of the hypopharynx. Those skilled in the art will understand that these dimensions and configurations described herein are exemplary and can be varied to achieve the same purpose.

[0074] Figure 5 Illustrated along Figure 3 FIG2 shows a circumferential cross-sectional view of the airway device 100 taken along line L-L shown in FIG2 . The airbag 120 is shown in an inflated state, along with the airbag base 104. A recess or compartment 500 is provided on the front side of the airbag base 104, spanning the entire width along the transverse axis of the airbag base. The rear portion 414 of the inflated airbag 120 is attached to and retained within the compartment 500, while the front portion 412 of the inflated airbag 120 extends outward from the airbag base 104. The cover 106 of the airbag base 104 lies flat in the closed position, extending through the inner aperture 410 of the airbag 120. The cover 106 covers the top of the compartment 500, forming two openings on opposite sides for the front portion 412 of the airbag 120.

[0075] In one example, the compartment 500 has a height in the range of 2 mm to 4 mm and a length in the range of 2 cm to 3 cm. The width W of the cover 106 F In this example, the width W of the airbag base 104 is in the range of 4 to 6 mm, or approximately 5 mm, and the height HF of the cover 106 is in the range of 2 to 5 mm, or approximately 1 mm. BASE The height of the mirror channel 102 with the airbag base 104 is in the range of 22 mm to 18 mm, or about 20 mm.

[0076] Figure 6A and Figure 6B An embodiment of the distal outer portion 114 of the scope channel 102 is illustrated in greater detail, and in particular, the first and second inflation lumens 112, 122 are illustrated in greater detail. Figure 6AThe second inflation lumen 122 is fluidically coupled to the cuff 110 for inflation and deflation. An outer wall 604 of the scope channel 102 forms an opening 602 for the second inflation lumen 122. The second inflation lumen 122 extends from the conduit 402 through the opening 602 to fluidically couple with the cuff 110.

[0077] Next, about Figure 6B , the first inflation lumen 112 is fluidly coupled to the balloon 120 for inflation and deflation. The outer wall 604 of the scope channel 102 forms another opening 610 for the first inflation lumen 112. The first inflation lumen 112 extends from the conduit 402 through the opening 610 to the balloon base 104. The balloon base 104 forms another conduit 612 extending from a proximal portion of the balloon base 104 to the balloon 120. The first inflation lumen 122 is then fluidly coupled to the balloon 120.

[0078] 7A to 7C The embodiment of the air bag mount 104 is illustrated when the air bag 120 is in a deflated state. Figure 7A The air bag base is illustrated with the cover 106 in a closed position. Figure 7B Illustrated along Figure 7A 1 is a cross-sectional view of the airbag base 104 taken along line NN shown in FIG. Figure 7C The hinge 700 of the cover 106 is illustrated in a closed position. In an embodiment, the air bag base 104 defines two openings 710a and 710b on opposing sides. The deflated air bag 120 extends through the compartment 500, with a first portion of the deflated air bag 120 extending from the first opening 710a and a second portion of the deflated air bag 120 extending from the second opening 710b. In the closed position, the cover 106 extends through and covers the front opening leading to the compartment 500.

[0079] In an embodiment, a hinge 700 is located in the cover 106 and holds the cover 106 in the closed position. The hinge 700 includes one or more of a torsion spring, a spring hinge, a self-closing hinge, or another type of spring-loaded hinge. The hinge 700 automatically closes the cover 106 from the open position and holds the cover 106 in the closed position.

[0080] Figures 8A to 8C The embodiment of the air bag base 104 is illustrated when the air bag 120 is in a semi-inflated state. Figure 8A An air bag mount is illustrated wherein the cover 106 is forced partially open by the inflating air bag 120 . Figure 8B Illustrated along the Figure 8A 1 is a cross-sectional view of the airbag base 104 taken along line PP shown in FIG. Figure 8CThe hinge 700 of the cover 106 is illustrated in a half-open state of the cover 106. The hinge 700 (e.g., the torsion of the spring in the hinge 700) is adjusted so that the force of the inflating air bag 120 can open the cover 106. When the front side of the inflating air bag 120 expands beyond the cover 106, the hinge 700 automatically closes the cover 106.

[0081] Figure 9 A schematic block diagram illustrates an exemplary embodiment of a pressure regulator and control system ("regulator system") 900 for an airway device 100. For example, when the airway device 100 is implanted in a patient, the regulator system 900 is in fluid communication with the cuff 110 and / or the bladder 120 and inflates and regulates the pressure within the cuff 110 and / or the bladder 120. The regulator system 900 can monitor and control the pressure of the cuff 110 and the bladder 120 individually and separately.

[0082] Regulator system 900 includes a pressure controller 906 and a pneumatic system 920. Pressure controller 906 includes a processor device 908 and a memory device 910. Memory device 910 stores instructions that, when executed by processor device 908 or other components of regulator system 900, cause regulator system 900 to perform one or more functions described herein. Processor device 908 includes at least one processing circuit, such as a microprocessor, microcontroller, digital signal processor, microcomputer, central processing unit, field programmable gate array, programmable logic device, state machine, logic circuit, analog circuit, digital circuit, and / or any device that manipulates signals (analog and / or digital) based on hard-coded and / or operational instructions of the circuit. Memory device 910 includes a non-transitory memory device and can be internal memory or external memory, and can be a single memory device or multiple memory devices. Memory device 910 can be read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, and / or any non-transitory memory device that stores digital information.

[0083] The pressure controller 906 can be co-located in the same physical device as the pneumatic system 920, or can be located separately in a different device, such as a user device or other processing device. The pressure controller 906 also includes a user interface 912. The user interface 912 generates user input and output (I / O) and includes one or more of a display, keyboard, touch screen, mouse, touchpad, meter, switch, or other I / O device.

[0084] In operation, the desired predetermined pressure settings for the cuff 110 and the bladder 120 are determined by the pressure controller 906 in response to user input received by the user interface 912. Alternatively, one or more default pressure settings may be implemented, for example, in the absence of user input. Different pressure settings may be set for the cuff 110 and the bladder 120. The pressure settings may be predetermined pressures or within a pressure range, such as typically within plus or minus 5 cmH2O. For example, when the cuff 110 is a low volume high pressure (LVHP) cuff, the pressure setting for the cuff 110 is typically within a range of 50 cmH2O to 150 cmH2O. When the cuff 110 is a high volume low pressure (HVLP) cuff, the pressure setting for the cuff 110 is typically within a range of 10 cmH2O to 20 cmH2O.

[0085] In contrast, the pressure setting of bladder 120 can be a pressure within the range of 10 cmH2O to 50 cmH2O (plus or minus 5 cmH2O). Cuff 110 and bladder 120 can thus operate within different pressure ranges. Pressure controller 906 also determines the frequency of measuring and adjusting the pressure of cuff 110 and bladder 120, for example, through user input or default settings.

[0086] The pneumatic system 920 includes a first pneumatic path for the balloon 120, which includes, for example, a first air pump 922a and a release valve 924a, which is fluidically coupled to the balloon 120 via, for example, an output port 926a, an indicator balloon 124, and the lumen 112. The pneumatic system 920 also includes a second, different pneumatic path for the cuff 110, which includes a second air pump 922b and a release valve 924b, which is fluidically coupled to the cuff 110 via, for example, an output port 926b, an indicator balloon 126, and the lumen 122. Although two air pumps 922a, 922b are described herein, a single air pump including a valve or switch between the two fluid paths can be implemented. Thus, the pneumatic system 920 includes separate pneumatic paths to independently and individually fluidly increase or decrease the pressure in the cuff 110 and the balloon 120.

[0087] In operation, the pressure controller 906 receives pressure measurements from one or more pressure sensor devices 902, 904 to measure the internal pressure of the cuff 110 and the air bag 120. One of the cuff pressure sensor devices 902 can be positioned on the outer surface of the cuff 110 to measure tracheal wall pressure. Additional pressure sensor devices can also be implemented. The pressure sensor devices 902, 904 generate pressure measurements and transmit the pressure measurements to the pressure controller 906 via wired leads and / or wireless transmitters.

[0088] The regulator system 900 includes a pressure feedback loop in which a pressure controller 906 controls a pneumatic system 920 to adjust the pressure of the cuff 110 and the bladder 120, respectively, in response to pressure measurements. The pressure controller 906 sends a signal to the pneumatic system 920 to add air to or release air from the bladder 120 and / or the cuff 110. For example, to adjust the pressure in the bladder 120, the pressure controller 906 may send a signal to the air pump 922a to add air to the bladder 120, or to the release valve 924a to release air from the bladder 120. In another example, to adjust the pressure in the cuff 110, the pressure controller 906 may send a signal to the air pump 922b to add air to the cuff 110, or to the release valve 924b to release air from the cuff 110.

[0089] The regulator system 900 monitors the pressure measurements and automatically adjusts the pressure of the cuff 110 and bladder 120 to achieve a predetermined pressure setting. The pressure controller 906 can continuously monitor and adjust the pressure of the cuff 110 and bladder 120, or can monitor and adjust the pressure at predetermined intervals. The regulator system 900 can also include a visible and / or audible alarm in the event of an unsafe pressure measurement.

[0090] 10A to 10D An embodiment of a method of using an airway device 100 for clearing soft tissue to create an open airway and maintain an open airway during gastroscopic surgery is illustrated. Figure 10A , a method 1000 for inserting an airway device is described. First, at step 1002, the airway device 100 is inserted into the larynx of a patient. A gastroscope may be pre-inserted through the scope channel 102. After the airway device 100 is inserted at 1002, the airway device 100 is then positioned at 1004 to place the balloon 120 near the patient's larynx and hypopharynx and the cuff 110 in the upper esophagus. Positioning of the airway device 100 may be facilitated by utilizing a pre-inserted gastroscope as a guide, as described with respect to Figure 11 Described in more detail.

[0091] When so positioned, at step 1006, the balloon 120 is inflated and expanded radially outward to ultimately form a circular or elliptical ring with an inner aperture. The radially expanded balloon 120 pushes the soft tissue within the epiglottis and hypopharyngeal cavity (and adjacent laryngeal opening) toward the periphery to provide a more unobstructed air passage into the trachea. The inner aperture of the inflated balloon 120 provides an unobstructed air passage into the patient's trachea.

[0092] Although a balloon 120 is described herein, other mechanisms may be used to push the epiglottis and other soft tissues against the anterior wall of the hypopharynx. Although an inflatable balloon 120 is described herein, other mechanisms may be used to push the epiglottis and other soft tissues against the anterior wall of the hypopharynx during gastric surgery. For example, a circular or oval plastic or rubber ring may be attached to the exterior of the scope channel 102 via a hinge. During insertion, the ring may be placed relatively flat against the scope channel 102. The hinge may then be activated after insertion of the airway device 100 to deploy the ring, which then pushes the epiglottis and other soft tissues against the anterior wall of the hypopharynx. Other mechanisms may include a thin rectangular rubber or plastic member attached to the scope channel 102 via a hinge. When deployed via the hinge, the rectangular member extends across the hypopharynx to push the epiglottis and other soft tissues. Those skilled in the art will appreciate that these and other mechanisms may be implemented to push the epiglottis and other soft tissues against the anterior wall of the hypopharynx during gastric surgery.

[0093] At 1008, cuff 110 is inflated in the proximal esophagus to create a seal between cuff 110 and the esophageal wall. In some embodiments, the seal is a watertight seal. The inflated cuff 110 helps maintain the separation of the digestive tract and the airway. For example, the presence of cuff 110 helps prevent stomach contents from spilling into the airway. Additionally, cuff 110 helps eliminate the possibility of inadvertent spillage of irrigation fluid (used to clean a gastroscope) into the airway, such as during insertion or removal of airway device 100.

[0094] Figure 10B An embodiment of a method 1010 for maintaining airway device 100 during surgery is illustrated. Following insertion and expansion, an endoscopic procedure is typically performed. During this procedure, the pressures within cuff 110 and balloon 120 are maintained within first and second predetermined ranges, respectively. For example, cuff 110 is maintained within a first predetermined pressure range that maintains a good seal with the esophageal wall without excessively damaging the esophageal wall. Furthermore, balloon 120 is maintained within a second predetermined pressure range that effectively holds the epiglottis and soft tissues within the periphery of the hypopharyngeal cavity without damaging the soft tissue or epiglottis.

[0095] At step 1012, one or more pressure measurements associated with cuff 110 and balloon 120 are obtained from one or more pressure sensor devices. The one or more pressure sensor devices may measure esophageal wall pressure, for example, pressure exerted by cuff 110 on the esophageal wall. In another example, the one or more pressure sensor devices may measure pressure exerted by balloon 120 on soft tissue in the hypopharynx or epiglottis. The one or more pressure sensor devices may measure pressure within balloon 120 and / or cuff 110. These pressure measurements may be determined periodically or continuously.

[0096] Using these pressure measurements, a determination is made at 1010 (e.g., by pressure controller 906) as to whether the pressure measurement associated with bladder 120 is within a first predetermined range and / or at 1014 as to whether the pressure measurement associated with cuff 110 is within a second predetermined range. If the pressure measurements are within the predetermined ranges, method 1000 continues to periodically or continuously monitor pressure relative to cuff 110 and / or bladder 120.

[0097] When the esophageal wall or cuff pressure is greater than or less than a first predetermined pressure range, the pressure in cuff 110 is adjusted at step 1016. Additionally, when the pressure applied by balloon 120 or the pressure inside the balloon is greater than or less than a second predetermined pressure range, the pressure in balloon 120 is adjusted at step 1016. These steps may be performed at preset intervals or continuously. Thus, the pressures of cuff 110 and balloon 120 are independently controlled using separate pneumatic pathways.

[0098] Figure 10C Illustrated is a method for removing the airway device 100. At the conclusion of the gastroscopy procedure, the gastroscope is withdrawn from the scope channel 102 at 1022, and the cuff 110 and balloon 120 are deflated at step 1024. The airway device 100 is then removed from the patient's throat at 1026.

[0099] Figure 10D An embodiment of a method 1030 for positioning an airway device 100 within a patient is illustrated in greater detail. Given the delicate nature of the upper aerodigestive tract and the limited available space in the pharynx and larynx, insertion of the airway device 100 is crucial. At step 1032, the airway device 100 is preloaded with a gastroscope by inserting it through the scope channel 102. The airway device 100 is slid away from the distal tip of the scope, exposing a sufficient length of the insertion portion of the scope. The scope is then introduced into the patient and advanced into the proximal esophagus at step 1034. With the scope securely held in place, the airway device 100 is advanced until the scope channel 102 is inserted into the hypopharynx / proximal esophagus and the tip of the scope channel 102 is visible at the tip of the scope at 1036. This ensures that the cuff 110 on the scope channel 102 is properly positioned within the proximal esophagus. As the airway device 100 is thus inserted, the cuff 110 is stabilized by inflating it.

[0100] In an embodiment, the scope channel 102 comprises a transparent or translucent material so that the balloon 120 can be visible to the gastroscope. The gastroscope can be pulled into the scope channel to ensure proper placement of the balloon 120. This step can be performed before and / or after the balloon 120 is inflated.

[0101] The airway device 100 has several advantages that simplify the insertion process. Among the first advantages, the volume of the airway device 100 is minimized through a compact design. For example, the outer tube 130 (the conduit for air flow) is configured to accommodate the scope channel 102 within its lumen. This configuration minimizes the cross-sectional area of the tubular portion of the airway device 100 compared to having two separate tubes.

[0102] Secondly, during the device's introduction into the patient, the inflatable balloon 120 is in a deflated state. In this deflated state, prior to introduction, the balloon 120 is deflated and folded beneath the cover 106. This minimized balloon size significantly facilitates insertion of the airway device 100. The design of the cover 106 allows the balloon 120 to be contained, providing a smooth device surface for smooth insertion of the airway device 100. Without this design, even after the balloon 120 is deflated, it would create an irregular surface that could catch on the upper edge of the epiglottis, causing it to fold downward and block the laryngeal entrance. This blockage of the laryngeal entrance could have catastrophic consequences, even leading to death. To avoid these unfortunate events, the airway device 100 is equipped with a balloon cover 106 that not only covers the balloon 120 but also creates a smooth surface.

[0103] Third, the introduction and advancement of the airway device 100 is facilitated by utilizing a pre-inserted gastroscope as its guide. First, successful insertion of any device into the upper aerodigestive tract requires a clear path. This step is challenging because when a patient is deeply sedated, laryngeal structures become relaxed and collapsed, leading to complete or partial airway obstruction. Utilizing the novel devices and methods disclosed herein, successful introduction of the airway device 100 into the upper aerodigestive tract is ensured.

[0104] Figure 11 An embodiment of a method for delivering oxygenated air and maintaining patient ventilation during a gastroscopic procedure using an airway device 100 is illustrated. In this embodiment, the airway device 100 includes at least an outer tube 130 and an airway adapter 150, as described herein. The airway device 100 may also include a balloon 120 and / or a cuff 110. The airway adapter 150 includes a tubular port 154 configured and dimensioned for connection to a ventilator or other oxygen delivery source. The airway adapter 150 is attached to the outer tube 130, thereby creating a fluid connection with the intraluminal space 320 between the scope channel 102 and the outer tube 130 via a sealed airflow path 310. The flow of oxygenated air into the patient's lungs is enhanced by inflating the soft tissue-clearing balloon 120, resulting in a patent airway. If needed, ventilator-assisted ventilation can be achieved by connecting the tubular port 154 of the airway adapter 150 to a ventilator. Oxygenated air flows through the sealed airflow path 310 into the intraluminal space 320.

[0105] Method 1100 includes inserting and positioning the airway device 100 in the patient's larynx at 1102. If present, the cuff 110 is positioned in the upper esophagus and inflated at 1104. Additionally, the balloon 120, if present, is positioned near the patient's larynx and hypopharynx and also expanded at 1104. At 1106, the tubular opening 154 of the airway adapter is fluidly coupled to an oxygen source. The oxygen source may include a ventilator or other pressurized oxygen source. During the procedure, at 1108, air flow is maintained through the intraluminal space 320 and into the patient's trachea. At the conclusion of the procedure, at 1110, the oxygen source is detached from the airway adapter 150 and the airway device 100 is removed from the patient.

[0106] Airway device 100 can have various embodiments depending on the patient's needs. For example, when a patient does not require respiratory assistance, the added airway adapter 150 may not be necessary. In another embodiment, scope channel 102 may include cuff 110 to prevent gastric contents or irrigation fluid from leaking into the trachea, but not include balloon 120. In another embodiment, scope channel 102 may include balloon 120 to maintain an open airway during a medical procedure, but not include cuff 110.

[0107] The esophageal cuff 110 prevents gastric reflux by mechanically blocking the backflow of gastric contents into the pharynx and larynx. The inflated balloon 120 forms a circular or elliptical ring configured to retract soft tissue and / or the epiglottis from the center of the hypopharynx near the laryngeal opening to the periphery, thereby clearing the patient's airway. Furthermore, an inner hole 410 formed in the center of the inflated balloon 120 provides an unobstructed air passage into the patient's trachea. The airway adapter 150 and outer tube 130 provide an alternative airway to the trachea by creating a sealed airflow passage 310 between the scope channel 102 and the outer tube 130 that leads to the intraluminal space 320. The passage 310 can be enhanced by connecting the airway adapter 150 to an oxygen source. The airway device 100 offers numerous advantages in various configurations.

[0108] As can be used herein, the term "operable with" or "configurable to" indicates that an element includes one or more of a circuit, instruction, module, data, input, output, etc., to perform one or more of the described or necessary corresponding functions, and can also include inferred coupling to one or more other items to perform the described or necessary corresponding functions. As can also be used herein, the term "coupled," "coupled to," "connected to," and / or "connected" or "interconnected" includes a direct connection or link between nodes / devices and / or an indirect connection between nodes / devices via an intermediate item. As can further be used herein, the inferred connection (that is, one of the elements is connected to another element by inference) includes direct and indirect connections between two items in the same manner as "connected to." As can be used herein, the terms "substantially" and "approximately" provide industry-accepted tolerances for the relativity between their corresponding terms and / or items.

[0109] Note that various aspects of the present disclosure may be described herein as processes depicted as schematic diagrams, flow charts, flow diagrams, structure diagrams, or block diagrams. Although a flow chart may describe operations as a sequential process, many operations may be performed in parallel or simultaneously. Additionally, the order of the operations may be rearranged. A process terminates when its operations are completed. A process may correspond to a method, function, procedure, subroutine, subprogram, etc. When a process corresponds to a function, its termination corresponds to the function returning to the calling function or main function.

[0110] Without departing from the present disclosure, the various features of the present disclosure described herein can be implemented in different systems and devices. It should be noted that the foregoing aspects of the present disclosure are merely examples and should not be construed as limiting the present disclosure. The description of various aspects of the present disclosure is intended to be illustrative, not to limit the scope of the claims. As such, the present invention can be readily applied to other types of devices, and many substitutions, modifications, and variations will be apparent to those skilled in the art.

[0111] In the foregoing description, certain representative aspects have been described with reference to specific examples. However, various modifications and changes may be made without departing from the scope of the invention as set forth in the claims. The description and drawings are illustrative rather than restrictive, and modifications are intended to be included within the scope of the invention. Therefore, the scope of the invention should be determined by the claims and their legal equivalents, rather than solely by the examples described. For example, the components and / or elements recited in any device claim may be assembled or otherwise operably configured in various arrangements and are therefore not limited to the specific configuration recited in the claims.

[0112] Furthermore, certain benefits, other advantages, and solutions to problems have been described above with respect to particular embodiments; however, any benefit, advantage, solution to problems, or any element that may cause any particular benefit, advantage, or solution to occur or become more apparent should not be construed as a critical, required, or essential feature or component of any or all the claims.

[0113] As used herein, the terms "comprises," "comprising," "containing," "having," "including," or any variations thereof, are intended to refer to a non-exclusive inclusion such that a process, method, article, composition, or apparatus that comprises a list of elements includes not only those elements that are recited but may also include other elements not expressly listed or inherent to such process, method, article, composition, or apparatus. Other combinations and / or modifications of the above-described structures, arrangements, applications, proportions, elements, materials, or components used in the practice of the invention, except those not specifically recited, may be varied or otherwise specially adapted to a particular environment, manufacturing specifications, design parameters, or other operating requirements without departing from the general principles of the invention.

[0114] In addition, unless otherwise specified, references to singular elements are not intended to mean "one and only one", but rather "one or more". Unless otherwise specified, the term "some" refers to one or more. All structural and functional equivalents currently or hereafter known to those of ordinary skill in the art for the elements of the various aspects described throughout this disclosure are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is intended to be interpreted as a "means-plus-function" type element under 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for..." or, in the case of a method claim, the element is recited using the phrase "step for..."

Claims

1. A medical device, comprising: a scope channel configured for insertion into the proximal esophagus of a patient; as well as An inflatable balloon is attached to a distal portion of the scope channel, wherein, in an inflated state, the inflatable balloon forms a ring having an outer circumference and an inner circumference positioned substantially forward of the scope channel, and wherein the inner circumference of the inflatable balloon forms an inner hole.

2. The medical device according to claim 1, wherein The front portion of the outer circumference and the inner hole of the inflatable balloon extend outwardly from the front surface of the distal portion of the scope channel to form an air passageway outside and in front of the scope channel that enters the patient's trachea.

3. The medical device according to claim 1, wherein A rear portion of the outer circumference of the inflatable balloon is attached to a front surface of the distal portion of the scope channel.

4. The medical device according to claim 3, wherein When the inflatable bladder is in an inflated state, the front portion of the outer circumference and the inner hole of the inflatable bladder extend outwardly from the front surface of the distal portion of the scope channel at an approach angle.

5. The medical device according to claim 4, wherein When the inflatable bladder is in the deflated state, the inflatable bladder collapses and folds to facilitate insertion.

6. The medical device according to claim 1, wherein an anterior portion of the outer circumference of the ring configured to retract soft tissue and / or the epiglottis from a center of a hypopharynx in the patient's larynx to a periphery when the inflatable balloon is in an inflated state; and Wherein, when the inflatable balloon is in an inflated state, the inner hole is positioned between the retracted soft tissue and / or epiglottis and the front surface of the distal portion of the scope channel to provide an air passage into the patient's trachea.

7. The medical device according to claim 6, wherein The scope channel further includes a balloon mount configured to attach a rear portion of the outer circumference of the ring to the front surface of the distal portion of the scope channel, wherein the balloon mount comprises: a rear surface of the airbag mount, the rear surface coupled to the front surface of the distal portion of the scope channel; and The air bag mount has a front surface coupled to the rear portion of the outer circumference of the ring.

8. The medical device according to claim 7, wherein The airbag base also includes: A recess is formed in the air bag mount, the recess spanning the front surface of the air bag mount, wherein the recess is configured to retain the inflatable air bag in a deflated state along a transverse axis of the air bag mount.

9. The medical device according to claim 8, wherein The airbag base also includes: A cover is attached to the distal portion of the air bag mount by a spring hinge, wherein the cover extends along the top of the recess to cover the inflatable air bag within the air bag mount when the inflatable air bag is in a deflated state.

10. The medical device according to claim 9, wherein the proximal end of the cover being configured to open in response to an upward force exerted by the inflatable airbag during inflation to permit deployment of the inflatable airbag; and Wherein, after the inflatable airbag is deployed, the cover extends through the lower portion of the inner hole of the ring of the inflatable airbag in the inflated state and above the notch due to the recoil effect of the spring hinge.

11. The medical device according to claim 10, wherein: The recess of the airbag mount is configured to retain the front and rear portions of the outer circumference of the inflatable airbag in a deflated state, and wherein the cover is configured to cover the recess including the inflatable airbag in a deflated state.

12. The medical device according to claim 1, further comprising: an inflatable cuff attached to the scope channel distally relative to the inflatable balloon, the inflatable cuff being configured to create a seal with a wall of the proximal esophagus when inflated, wherein the scope channel is located within a cuff inner aperture formed by the inflatable cuff, and wherein, when inflated, the inflatable cuff radially expands from the scope channel.

13. The medical device according to claim 12, further comprising: a first inflation lumen coupled to the inflatable balloon; a second inflation lumen coupled to the inflatable cuff; as well as A pressure regulator, the pressure regulator being configured to: regulating a first pressure in the inflatable balloon using the first inflation lumen; and A second pressure in the inflatable cuff is adjusted using the second inflation lumen.

14. The medical device according to claim 1, further comprising: an outer tube defining an interior space that accommodates at least a portion of the scope channel proximal to the inflatable balloon and distal to a proximal opening of the scope channel, wherein an inner wall of the outer tube and an outer wall of the scope channel define an intraluminal space, wherein the intraluminal space provides a pathway for air flow into the patient's hypopharynx and into the inner bore of the ring of the inflatable balloon located in the patient's trachea.

15. The medical device of claim 14, further comprising an adapter, wherein the adapter comprises: a first proximal port that forms a seal around the proximal opening of the scope channel; a distal mouth that forms a seal around the outer tube; a second proximal port configured for connection to a ventilator or oxygen delivery tube; as well as A sealed air flow passage extends from the second proximal port to the intraluminal space to provide air flow from the second proximal port to the intraluminal space.

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