Systems and methods for endoscopic airway devices

Abstract

The airway device includes an outer tube and a scope channel partially surrounded by the outer tube. The intraluminal space within the outer tube not occupied by the scope channel provides a passageway for airflow to the patient. An esophageal cuff is positioned distal to the scope channel. When inflated, the esophageal cuff secures the airway device in the patient's proximal esophagus and helps prevent reflux by mechanically blocking gastric contents from entering the larynx. An inflatable bladder 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 bladder forms a tubular ring that compresses the epiglottis and / or other soft tissues against the hypopharyngeal wall, creating an unobstructed airway into the patient's trachea.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 17 / 991,827, entitled "System and Method for an Endoscopic Airway Device," filed with the United States Patent Office on November 21, 2022, the entire contents of which are incorporated herein by reference for all applicable purposes as if fully set forth below in their entirety.

[0002] The present application relates to systems and methods for airway devices, and more particularly to airway devices configured for gastrointestinal endoscopy or upper gastrointestinal endoscopy procedures. [Background technology]

[0003] An estimated 31 million upper gastrointestinal (UGI) endoscopies and procedures are performed annually in the United States. UGI endoscopies are performed to examine the esophagus, stomach, and first portion of the small intestine (called the duodenum). UGI procedures include endoscopic retrograde cholangiopancreatography (ERCP), endoscopic band ligation, percutaneous endoscopic gastrostomy (PEG), and transesophageal echocardiography (TEE). These procedures present unique airway challenges with significant clinical impact for several reasons.

[0004] First, when inserted, a gastroscope, with a diameter of 8–13 mm, occupies a large portion of the patient's airway space. As a result, the total space available for breathing is reduced. This airway invasion by the endoscope places 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 due to the endoscope's large cross-sectional area is a major contributing factor. According to the American Association of Nurse Anesthetists (AANA) Foundation's non-public claims database, respiratory events are the leading cause of adverse outcomes. The American Society of Anesthesiologists (ASA) non-public claims database reported that the most common sedation malpractice claim is inadequate oxygenation / ventilation, with over 80% of claims of this nature resulting in brain injury or death.

[0005] Second, the presence of a gastroscope in the throat limits the anesthesiologist's access to the airway, if necessary. If a patient experiences clinically significant oxygen deprivation and respiratory failure during a gastroscopy procedure, the anesthesiologist has only a few minutes to correct the patient's respiratory status before permanent damage to the brain and other organs of the body occurs. The need to manipulate the endoscope makes it more difficult for the anesthesiologist to quickly restore much-needed respiratory stability.

[0006] Third, most gastroscopy procedures are performed under deep sedation to minimize patient discomfort and suppress the gag, cough, and laryngospasm reflexes. These benefits have led to the growing popularity of deep sedation. Nevertheless, this anesthetic technique carries very real risks. One consequence of deep sedation is loss of pharyngeal and laryngeal muscle tone and suppression of respiratory drive, leading to upper airway obstruction and apnea, respectively. Both of these effects of deep sedation can lead to hypoxia or brain and other organ damage. The general trend in the United States is an aging population, with increasing comorbidities such as sleep apnea and obesity, which can further exacerbate airway obstruction.

[0007] Fourth, attenuation of protective airway reflexes and decreased tone of the upper and lower esophageal sphincters, the patient's supine position during gastroscopy, air or fluid insufflation, and pharyngeal irritation during gastroscopy can lead to regurgitation and aspiration of gastric contents. Aspiration can cause mild symptoms such as coughing, which can lead to premature termination of the procedure. However, aspiration often leads to more serious problems such as laryngospasm, bronchospasm, and pneumonia, all of which can be potentially fatal.

[0008] Fifth, the airway is not fully protected during gastroscopy. There is no barrier to prevent gastric reflux, irrigation fluid, or patient secretions from leaking into the airway. Once such fluids and secretions enter the airway, the situation is exacerbated by the patient's reduced ability to clear them.

[0009] Currently, existing oral and nasal airway devices are inadequate to effectively address the aforementioned challenges associated with gastroscopy. Therefore, there is an urgent need for airway devices that can efficiently and effectively relieve obstruction of redundant pharyngeal tissue and maintain a patent airway. There is also an urgent need for airway devices that can interface with oxygen delivery devices and ventilators. Furthermore, there is a need for airway devices that allow separation of the gastrointestinal tract from the respiratory tract to prevent gastric contents from entering the respiratory tract. And, above all, there is an urgent need for airway devices that are easy to introduce into the patient's throat, because establishing a patent upper airway easily and quickly significantly affects patient outcomes. Such devices would contribute to improved patient outcomes and satisfaction. Furthermore, because inadequate ventilation and oxygen delivery are significant causes of medical malpractice lawsuits, they would help reduce the risk of litigation for healthcare providers and hospital systems. Summary of the Invention

[0010] In one aspect, the medical device includes a scope channel configured for insertion into a patient's throat and an inflatable bladder attached to a front surface of a distal portion of the scope channel, wherein in an inflated state the bladder forms a ring extending outward from the front surface of the scope channel.

[0011] In another aspect, a method of airway device includes inserting a gastroscope through a scope channel, introducing the gastroscope into the patient and advancing the gastroscope into the patient's proximal esophagus, and inserting an airway device into the patient's throat and proximal esophagus until the tip of the scope channel is visible on the gastroscope. The method also includes using an inflatable bladder on the scope channel to push the patient's hypopharyngeal soft tissue and / or epiglottis against the peripheral hypopharyngeal wall.

[0012] In another aspect, a medical device includes a scope channel configured for insertion into a patient's throat, and an outer tube surrounding a portion of the scope channel and forming an intraluminal space between an inner wall of the outer tube and an outer wall of the scope channel. The medical device further includes an inflatable bladder attached to a front surface of a distal portion of the scope channel, wherein in an inflated state the bladder forms a ring extending outward from the front surface of the scope channel, and an inflatable cuff attached distally from the bladder on the scope channel, the scope channel disposed within an internal lumen formed by the inflatable cuff, the inflatable cuff expanding radially from the scope channel when inflated.

[0013] In one or more of the above aspects, the inflatable bladder includes a rear portion attached to a front surface of the distal portion of the scope channel and a front portion, the front portion extending outwardly at a proximal angle from the front surface of the scope channel when the inflatable bladder is in an inflated state.

[0014] In one or more of the above aspects, when the inflatable bladder is in an inflated state, the front portion of the inflatable bladder is configured to constrict soft tissue and / or the epiglottis from the center to the periphery of the patient's throat.

[0015] In one or more of the above aspects, the scope channel further comprises a bladder base including a rear face coupled to a front face of the distal portion of the scope channel and a front face coupled to a rear portion of the inflatable bladder.

[0016] In one or more of the above embodiments, the bladder base further includes a recess extending to a front surface of the bladder base configured to retain a front portion of the inflated bladder along a transverse axis of the bladder base. The bladder base also includes a cover attached to a distal portion of the bladder base by a spring hinge, the cover extending through the lumen of the inflated bladder and covering a top of the recess in the closed position.

[0017] In one or more of the above aspects, the cavity in the bladder base is configured to hold the front and rear portions of the bladder in a contracted state, and the hinged cover is configured to cover the cavity containing the bladder in the contracted state.

[0018] In one or more of the above aspects, the inflatable cuff is attached distally from the bladder on the scope channel, the scope channel is disposed within an inner lumen formed by the inflatable cuff, and the inflatable cuff expands radially from the scope channel upon inflation.

[0019] In one or more of the above aspects, the inflatable cuff is configured to create a seal with the wall of the proximal esophagus when inflated.

[0020] In one or more of the above aspects, the first inflation lumen is coupled to the inflatable bladder and the second inflation lumen is coupled to the inflatable cuff.

[0021] In one or more of the above aspects, the pressure regulator is configured to regulate a first pressure in the inflatable bladder using the first inflation lumen and to regulate a second pressure in the inflatable cuff using the second inflation lumen.

[0022] In one or more of the above aspects, the outer tube forms an interior space proximal to the inflatable bladder and accommodating at least a portion of the scope channel distal to the proximal opening of the scope channel, and the inner wall of the outer tube and the outer wall of the scope channel form an intraluminal space.

[0023] 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, and the adapter further includes a second proximal port and a sealed airflow passage extending from the second proximal port to the intraluminal space.

[0024] In one or more of the above embodiments, the method includes using an airway device to create a seal between the scope channel and the wall of the proximal esophagus.

[0025] In one or more of the above aspects, the method includes inserting a gastroscope through a scope channel, introducing the gastroscope into the 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 on the gastroscope.

[0026] In one or more of the above aspects, the method includes inflating a cuff attached to a distal portion of the scope channel, the inflatable cuff expanding radially from the scope channel upon inflation to form a seal between the scope channel and a wall of the proximal esophagus.

[0027] In one or more of the above aspects, the method includes inflating a bladder attached to the anterior surface of the distal portion of the scope channel, wherein in the inflated state, the bladder forms a ring extending outward from the anterior surface of the scope channel and presses the patient's hypopharyngeal soft tissue and / or epiglottis against the peripheral wall of the hypopharynx.

[0028] In one or more of the above aspects, the method includes adjusting a first pressure in the bladder using a first inflation lumen and adjusting a second pressure in the cuff using a second inflation lumen.

[0029] In one or more of the above aspects, the method includes inserting oxygenated air into a sealed airflow passageway extending to the intraluminal space between the inner wall of the outer tube and the outer wall of the scope channel.

[0030] In one or more of the above aspects, the bladder base includes a rear face coupled to a front face of the distal portion of the scope channel, a front face coupled to a rear portion of the inflatable bladder, and a recess in the front face of the bladder base, wherein the inflatable bladder is folded into the recess in a deflated state. The bladder base can also include a cover attached by a spring hinge to a distal portion of the front face of the bladder base, the cover extending along a top of the recess and covering the inflatable bladder in a deflated state folded into the recess.

[0031] In one or more of the above embodiments, during inflation, the inflatable bladder applies a force to a proximal portion of the cover of the bladder base to open the cover, and as the inflatable bladder expands, the rebound action of the spring hinge causes the cover to return to a closed position through the inner lumen of the inflatable bladder, covering the top of the recess. [Brief explanation of the drawings]

[0032] [Figure 1] FIG. 1 shows a perspective view of one embodiment of an airway device. [Figure 2] FIG. 2 shows one embodiment of an airway device placed in vivo in the throat of a patient. [Figure 3] FIG. 3 shows one embodiment of a longitudinal cross-sectional view of an airway device. [Figure 4] FIG. 4 shows one embodiment of a circumferential cross-section of an airway device. [Figure 5] FIG. 5 shows one embodiment of another circumferential cross-section of the airway device. [Figure 6]6A-6B show one embodiment of the distal portion of the scope channel 102 in further detail. [Figure 7] 7A-7C show an embodiment of the bladder base with the bladder in a deflated state. [Figure 8] 8A-8C show an embodiment of the bladder base with the bladder in a semi-inflated state. [Figure 9] FIG. 9 shows a schematic block diagram of an exemplary embodiment of a pressure regulator and control system. [Figure 10] 10A-10D illustrate an embodiment of a method of an airway device during a gastroscopy procedure. [Figure 11] FIG. 11 illustrates one embodiment of an airway device method for providing oxygenated air to a patient during a gastroscopy procedure. DETAILED DESCRIPTION OF THE INVENTION

[0033] The words "exemplary" or "embodiment" are used herein to mean "serving as an example, instance, or illustration." Any implementation or aspect described herein as "exemplary" or "one embodiment" is not necessarily to be construed as preferred or advantageous over other aspects of the disclosure. Likewise, the term "aspect" does not require that all aspects of the disclosure include the discussed configuration, advantage, or mode of operation.

[0034] 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 one skilled in the art that these and other aspects may be practiced without some or all of these specific details. Additionally, well-known steps within process methods may be omitted from flow diagrams shown herein so as not to obscure aspects of the present disclosure. Similarly, well-known components within devices may be omitted from figures and descriptions thereof shown herein so as not to obscure aspects of the present disclosure.

[0035] Disclosed herein are systems, methods, and devices utilized to maintain a reliable and safe airway during medical procedures involving an esophageal tube, such as gastroscopy procedures under sedation. The endoscopic airway device includes an outer tube having a proximal end and a distal end. Disposed within the outer tube and secured to its interior wall is a scope channel. The scope channel is a flexible tubular structure configured to allow passage of a gastroscope. The extra space within the outer tube, i.e., the intraluminal space not occupied by the scope channel, provides a passageway for airflow to the patient.

[0036] The distal end of the scope channel extends outward from the distal opening of the outer tube. Located at the distal end of the scope channel is an inflatable esophageal cuff. When inflated, the esophageal cuff secures retention of the airway device in the patient's hypopharynx / proximal esophagus and helps prevent gastric reflux by mechanically blocking the reflux of gastric contents into the pharynx and larynx. An inflatable bladder 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 bladder forms a circular or oval ring with a central lumen. The inflated bladder presses the soft tissues of the hypopharynx and epiglottis from the center toward the peripheral wall of the hypopharynx, the region between the oropharynx at the level of the hyoid bone and the esophagus at the inferior end of the cricoid cartilage. The space created in the center of the inflated bladder provides an unobstructed passage of air into the patient's trachea. Thus, the bladder effectively clears the hypopharynx adjacent to the laryngeal opening, providing a clear airway.

[0037] FIG. 1 shows a perspective view of one embodiment of an airway device 100. The airway device 100 is a medical device configured for insertion into a patient's throat. In one embodiment, the airway device includes a scope channel 102 and an outer tube 130. The outer tube 130 is an oval-shaped hollow tube configured to fit within the patient's throat and hypopharynx. The outer tube 130 forms an interior space that accommodates at least a portion of the scope channel 102. The outer tube 130 can be designed to be semi-rigid / semi-flexible and can be made from a material that meets certain rigidity / flexibility requirements (e.g., but is not limited to, being able to bend to fit efficiently within the patient's throat). 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, a portion of the semi-rigid portion of the outer tube 130 can include a corrugated configuration that allows for additional flexibility. The outer tube 130 is sized and molded to fit within the patient's throat. The interior space of the outer tube 130, i.e., the intraluminal space not occupied by the scope channel 102, provides a passageway for airflow to the patient.

[0038] The scope channel 102 is a flexible tubular structure that forms a circular or oval hollow channel. Like the outer tube 130, the scope channel 102 can be designed to be semi-rigid / semi-flexible and can be made from materials that meet the necessary rigidity / flexibility requirements (e.g., but are not limited to, the ability to bend to fit efficiently within the patient's throat). In certain embodiments, the scope channel 102 may comprise a polymer tubing such as, but not limited to, polyvinyl chloride (PVC), silicone, and / or other thermoplastic materials. In embodiments, a portion of the semi-rigid portion of the scope channel 102 may include a corrugated configuration to provide additional flexibility.

[0039] 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 secured to the inner wall of the outer tube 130. At the distal end, the scope channel 102 protrudes and extends outwardly from a distal opening 132 of the outer tube 130. At least this distal portion of the scope channel 102 is configured with a shape and size to fit within the patient's hypopharynx and esophagus.

[0040] In one embodiment, the outer portion 114 of the scope channel 102, protruding from the outer tube 130, includes an inflatable cuff 110. The inflatable cuff 110 is a torus-shaped ring that forms a lumen within which the scope channel 102 fits. The cuff 110 may include a low-volume, high-pressure (LVHP) type cuff or a high-volume, low-pressure (HVLP) type cuff. The first type, the LVHP cuff, is made of a stiff, relatively inelastic material. Due to its inherent stiffness, a greater level of pressure (50 cmH2O to 100 cmH2O) is required to inflate the LVHP type cuff. The second type, the HVLP cuff, is constructed of a more resilient, more flexible material that inflates at a lower pressure. To compensate for its low-pressure characteristics and create a seal against the tracheal wall, the diameter of the HVLP cuff is generally 1.5 to 2 times the diameter of the trachea when fully inflated. The inflatable cuff may also include a combination of both an LVHP type cuff and an HVLP type cuff, as described in U.S. Patent Application No. 17 / 848,273, entitled "SYSTEM AND METHOD FOR AN ENDOTRACHEAL TUBE CUFF ASSEMBLY," filed June 23, 2022, and incorporated herein by reference.

[0041] The cuff 110 is inflated and deflated after the airway device 100 is introduced into the patient and positions the cuff 110 in the patient's esophagus. When inflated, the cuff 110 creates a seal against the esophageal wall and serves two important functions: 1. Secure retention of the airway device 100 in the patient's hypopharynx / proximal esophagus, and 2. Prevents gastric reflux by mechanically blocking stomach contents from refluxing into the pharynx and larynx.

[0042] In one embodiment, the external portion 114 of the scope channel 102, which protrudes from the outer tube 130, also includes an inflatable bladder 120. The inflatable bladder 120 is disposed proximal to the inflatable cuff 110 and distal to the outer tube 130. In an inflated state, the bladder 120 expands into a circular or oval ring shape having an internal lumen. The front of the inflated bladder 120 extends outward from the scope channel 102. The rear of the ring is coupled to the front of the external portion 114 of the scope channel 102 along its transverse axis (e.g., along the circumference of the scope channel 102).

[0043] In one embodiment, the bladder 120 is attached to the scope channel 102 by a bladder base 104. The bladder base 104 may be secured to the front of the exterior portion of the scope channel 102 between the cuff 110 and the distal opening 132 of the outer tube 130. The rear surface of the bladder base 104 is configured to at least partially surround the exterior surface of the scope channel 102. The front surface of the bladder base 104 is oval-shaped and forms a recess that attaches to the underside of the bladder 120. The bladder 120 lies across this recess in the bladder base 104.

[0044] Longitudinally across the top of the recess is a bladder cover 106, which has a distal end attached and secured to the bladder base 104 and a proximal end that is unattached. The cover 106 covers the deflated bladder 120 and provides a smoother surface for the airway device 100. This smoother surface facilitates the insertion process of the airway device 100 by allowing the airway device 100 to slide more easily into the patient's pharynx. Without such a smooth surface, the inflated bladder, even when deflated, could create an irregular surface that could potentially catch on the upper edge of the epiglottis, potentially causing the epiglottis to fold downward and block the laryngeal inlet. Instead, the deflated bladder 120 is seated within the recess in the bladder base 104 and is covered by the cover 106, creating a smooth surface. This smooth surface of the bladder base 104 facilitates insertion of the airway device 100.

[0045] The cover 106 may comprise a highly resilient material, i.e., a material that can be easily bent and has a strong tendency to return to its original state. In this manner, when the bladder 120 is inflated, the cover 106 has a low bending stiffness and therefore flexes to allow the inflated bladder 120 to unfold from under the bladder cover 106. Once the bladder 120 is inflated, the bladder cover 106 returns to its original position, covering the recessed space and the rear of the bladder 120 and allowing a clear air passage without interference from the bladder cover 106. In another embodiment, a spring hinge may be attached to the bladder cover 106 and bladder base 104 to hold the bladder cover 106 in a closed position.

[0046] At the proximal segment of airway device 100, a flange 140 extends from the side of outer tube lateral surface 130. Flange 140 is configured to be placed externally over a patient's mouth to stabilize airway device 100. Flange 140 includes slits or holes 142a-d at the opposite end for attachment of a cloth tie or strap that wraps around the patient's neck.

[0047] Proximal to the airway device 100, a scope channel 102 extends outward from the outer tube 130. In one embodiment, 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 into the outer tube 130, which includes the scope channel 102. An endoscope or other instrument can then be inserted through the scope channel 102 and into the esophagus.

[0048] The airway adapter 150 further includes a second proximal port 154 that forms a seal in the intraluminal space between the scope channel 102 and the outer tube 130. The proximal port 154 is configured and sized to connect to a ventilator or oxygen delivery tube, which can then provide airflow into the intraluminal space between the scope channel 102 and the outer tube 130. The airway adapter 150 is optional. If the patient's respiratory status is sufficient on room air and they do not require assistance with breathing, the airway adapter 150 can be omitted from the airway device 100.

[0049] First and second inflation lumens 112, 122 extend outwardly from the proximal opening of scope channel 102. First inflation lumen 112 is fluidly coupled to bladder 120 for inflation and deflation, and second inflation lumen 122 is fluidly coupled to cuff 110 for inflation and deflation. Pilot balloons 124 and 126 provide indications of pressure and inflation of bladder 120 and cuff 110, respectively.

[0050] In use, airway device 100 provides a method for removing soft tissue from a patient's larynx and hypopharynx. Airway device 100 is inserted into a patient, after which bladder 120 is positioned adjacent the patient's larynx and hypopharynx. Once so positioned, bladder 120 is radially inflated and expanded, ultimately forming a circular or elliptical ring with a central lumen. This radial expansion of inflatable bladder 120 pushes soft tissue normally present in the hypopharyngeal lumen adjacent the laryngeal opening toward the periphery of the hypopharynx, providing an unobstructed airway to the patient's trachea.

[0051] 2 shows one embodiment of airway device 100 placed in vivo in the throat of a patient 200. Although a human patient 200 is shown herein, airway device 100 can also be used in other animals.

[0052] Airway device 100 is configured to extend from the patient's mouth into the hypopharynx 210 and into the proximal portion of the esophagus 202 of the patient 200. 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 cuff 110 at the distal end of scope channel 102 prevents stomach contents or irrigation fluid from spilling into the trachea 204. Cuff 110 further eliminates the possibility of inadvertent spillage of irrigation fluid or dropping foreign objects into the airway during scope insertion or removal.

[0053] The airway device 100 is also positioned so that the bladder 120 is adjacent to the patient's larynx and hypopharynx 210. Once so positioned, the bladder 120 inflates to a rigid circular or oval ring shape. The inflatable bladder 120 expands radially until it eventually forms a circular or oval ring with a central lumen. This radial expansion of the inflatable bladder 120 pushes the soft tissue normally present in the hypopharyngeal lumen adjacent the laryngeal opening, including the epiglottis 208, toward the periphery of the hypopharynx, providing an unobstructed airway to the patient's trachea 204. The lumen created in the center of the inflated bladder 120 provides an unobstructed airway to the patient's trachea.

[0054] 3-5 illustrate various cross-sectional views of one embodiment of airway device 100. While various dimensions and measurements are shown in the figures, these dimensions and measurements are exemplary and may vary depending on, for example, the patient, application, or other factors. With reference to FIG. 3, a longitudinal cross-sectional view of airway device 100 is shown, including scope channel 102, outer tube 130, and airway adapter 150. In scope channel 102, first inflation lumen 112 and second inflation lumen 122 extend from a proximal opening of scope channel 102 through a hollow space formed in the front wall 302 of scope channel 103 to bladder 120 and cuff 110, respectively. Because cuff 110 extends radially around scope channel 102, first lumen 122, which is fluidly coupled to cuff 110, may alternatively be located within the rear or side wall of the scope channel.

[0055] The outer tube 130 surrounds only a portion of the scope channel 102 proximal to the inflatable bladder 120 and distal to the proximal opening 152 of the scope channel 102. As seen in this cross-sectional view, a proximal portion 330 of the scope channel 102 extends outwardly from the proximal opening of the outer tube 130, proximal to the flange 140. The airway adapter 150 includes a proximal upper surface 312 that forms a proximal opening or mouth configured to sealingly fit around the proximal mouth 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 mouth 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 opening 154 formed by the airway adapter 150 is configured and sized to connect to a ventilator or oxygen delivery tube, which can then insert oxygenated air into the intraluminal space 320. The oxygenated air flows through the intraluminal space 320 and into the patient's cleared airway in the hypopharynx.

[0056] When inflated, the bladder 120 is positioned laterally from the base 104, expanding outward and tilting proximally away from the upper surface of the scope channel 102 and / or base 104. Specifically, the bladder 120 is tilted at a proximal angle from vertical toward the front of the scope channel 102. For example, the proximal angle may range from 0 to 30 degrees, or 5 to 25 degrees, or 10 to 20 degrees. This proximal angle is exemplary and may vary depending on factors such as the placement of the bladder 120 on the scope channel 102, the extension of the bladder 120 from the scope channel 102, and the size of the patient's throat. Those skilled in the art will understand from this description that the dimensions of the bladder 120 and the angular positioning of the bladder 120 are configured to hold the soft tissues in the hypopharyngeal lumen adjacent the laryngeal opening, including the epiglottis 208, against the peripheral walls of the hypopharynx, thereby providing an unobstructed airway to the patient's trachea.

[0057] In one example, the length L of the outer tube 130 OT An exemplary length of the bladder base 104 is 30 mm to 60 mm. An exemplary height of the recess or compartment in the bladder base 104 is 2 mm to 4 mm, and an exemplary length is 2 cm to 3 cm.

[0058] Figure 4 shows a circumferential cross-section of airway device 100 taken along line HH shown in Figure 3. As shown in Figure 4, the outer circumference of scope channel 102 is smaller than the outer circumference of outer tube 130, allowing scope channel 102 to fit within outer tube 130 while leaving an intraluminal space 320 between scope channel 102 and outer tube 130. The outer rear wall of scope channel 102 is attached to or integrally formed with the inner rear wall of outer tube 130 at line 400. As such, intraluminal space 320 is larger at the front of airway device 100.

[0059] Within the front wall 302 of the scope channel 102, the first inflation lumen 112 and the second inflation lumen 122 extend through a hollow duct 402 formed in the front wall 302 of the scope channel 102. In another embodiment, the duct 402 can be attached to the front inner wall or the front outer wall of the scope channel 102.

[0060] In one example, the outer tube 130 has a vertical diameter VD OT Horizontal diameter HD greater than OT For example, the outer wall of the outer tube 130 may have a horizontal diameter HD in the range of 25-23 mm or about 24 mm. OT-EW The outer wall of the outer tube 130 may have a vertical diameter VD in the range of 22-23 mm or about 21 mm. OT-EW The inner wall of the outer tube 130 may have a horizontal diameter HD in the range of 21-19 mm or about 20 mm. OT-IW and the inner wall of the outer tube 130 may have a vertical VD in the range of 18-16 mm or about 17 mm. OT-IW The outer tube 130 may have a larger oval shape with a horizontal diameter greater than the vertical diameter. The wall thickness of the outer tube 130 may be in the range of 3-5 mm or about 4 mm.

[0061] In this example, the scope channel 102 has an outer wall diameter D of 14-16 mm or about 15 mm. SC-OW To accommodate the hollow duct 402 in the front wall 302 of the scope channel 102, the thickness of the front wall 302 can be greater than the thickness of the rear wall 404 of the scope 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 may be 13 mm elsewhere.

[0062] Bladder 120 is a circular ring in this example, but may also be an oval ring. The tubular ring of bladder 120 creates an internal lumen 410. A rear portion 414 of bladder 120 is attached to bladder base 104, while a front portion 412 of bladder 120 extends outward from scope channel 102. An exemplary diameter of the outer periphery of bladder 120 is approximately 10 mm to 20 mm. An exemplary diameter of the inner periphery of bladder 120 is approximately 5 mm to 10 mm. These dimensions and configuration of bladder 120 are designed to enable bladder 120 to reach soft tissue and / or the epiglottis and push it around the hypopharynx. Those skilled in the art will appreciate that these dimensions and configurations described herein are exemplary and may be varied to achieve the same purpose.

[0063] FIG. 5 shows a circumferential cross-section of the airway device 100 taken along line LL shown in FIG. 3. The bladder 120 is shown in an inflated state along with the bladder base 104. Disposed on the front of the bladder base 104 is a recess or compartment 500 that spans the entire width of the bladder base along its transverse axis. The rear portion 414 of the inflated bladder 120 attaches to and remains within compartment 500, while the front portion 412 of the inflated bladder 120 extends outward from the bladder base 104. The cover 106 of the bladder base 104 lies flat in a closed position extending through the inner lumen 410 of the bladder 120. The cover 106 covers the top of compartment 500 and forms two openings on opposite sides for the front portion 412 of the bladder 120.

[0064] In one example, the height of the section 500 is in the range of 2 mm to 4 mm, and the length is in the range of 2 cm to 3 cm. F The width W of the bladder base 104 is in the range of 4 to 6 mm or about 5 mm, and the height HF of the cover 106 is in the range of 2 to 0.5 mm or about 1 mm. BASE The height of the scope channel 102 with the bladder base 104 is in the range of 22 to 18 mm or approximately 20 mm.

[0065] 6A and 6B show one embodiment of the distal exterior portion 114 of the scope channel 102 in greater detail, and in particular the first inflation lumen 112 and the second inflation lumen 122 in greater detail. Referring first to FIGS. 6A and 6B, the second inflation lumen 122 is fluidly coupled to the cuff 110 for inflation and deflation. The 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 duct 402 through the opening 602 and is fluidly coupled to the cuff 110.

[0066] 6B, the first inflation lumen 112 is fluidly coupled to the bladder 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 duct 402 through the opening 610 to the bladder base 104. The bladder base 104 forms another duct 612 that extends from a proximal portion of the bladder base 104 to the bladder 120. The first inflation lumen 122 is then fluidly coupled to the bladder 120.

[0067] 7A-7C show an embodiment of the bladder base 104 when the bladder 120 is in a deflated state. FIG. 7A shows the bladder base with the cover 106 in a closed position. FIG. 7B shows a cross-sectional view of the bladder base 104 along line NN shown in FIG. 7A. FIG. 7C shows the hinge 700 of the cover 106 in the closed position. In one embodiment, the bladder base 104 forms two openings 710a-b on opposite sides. The deflated bladder 120 extends through the compartment 500, with a first portion of the deflated bladder 120 extending from the first opening 710a and a second portion of the deflated bladder 120 extending from the second opening 710b. The cover 106 in the closed position extends across and covers the front opening of the compartment 500.

[0068] In one embodiment, a hinge 700 is disposed within the cover 106 and holds the cover 106 in a closed position. The hinge 700 includes one or more of a torsion spring, a spring hinge, a self-closing hinge, or other type of spring-loaded hinge. The hinge 700 automatically closes the cover 106 from an open position and holds the cover 106 in a closed position.

[0069] 8A-8C illustrate an embodiment of the bladder base 104 when the bladder 120 is in a semi-inflated state. FIG. 8A illustrates the bladder base with the cover 106 partially forced open by the inflated bladder 120. FIG. 8B illustrates a cross-sectional view of the bladder base 104 along line PP shown in FIG. 8A. FIG. 8C illustrates the hinge 700 of the cover 106 with the cover 106 in a partially open state. The hinge 700, e.g., the torsion of a spring within the hinge 700, is adjusted to allow the force of the inflated bladder 120 to open the cover 106. When the front of the inflated bladder 120 expands beyond the cover 106, the hinge 700 automatically closes the cover 106.

[0070] 9 shows a schematic block diagram of an exemplary embodiment of a pressure regulator and control system ("regulator system") 900 for airway device 100. Regulator system 900 is in fluid communication with and inflates and regulates the pressure in cuff 110 and / or bladder 120, for example, when airway device 100 is implanted in a patient. Regulator system 900 can monitor and control the pressure in cuff 110 and bladder 120 separately and independently.

[0071] 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-coding of circuit and / or operational instructions. Memory device 910 includes a non-transitory memory device, can be internal memory or external memory, and can be a single memory device or multiple memory devices. The 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.

[0072] The pressure controller 906 may be co-located with the pneumatic system 920 in the same physical device or may be separately located in a different device, such as a user device or other processing device. The pressure controller 906 further 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, touch pad, gauges, switches, or other I / O devices.

[0073] During operation, the pressure controller 906 determines desired predetermined pressure settings for the cuff 110 and bladder 120 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. Alternate pressure settings may be set for the cuff 110 and bladder 120. The pressure setting may be a predetermined pressure or within a pressure range, typically within ±5 cmH2O. For example, if the cuff 110 is a low volume, high pressure (LVHP) type cuff, the pressure setting for the cuff 110 is typically within a range of 50 cmH2O to 150 cmH2O. If the cuff 110 is a high volume, low pressure (HVLP) type cuff, the pressure setting for the cuff 110 is typically within a range of 10 cmH2O to 20 cmH2O.

[0074] In contrast, the pressure setting for the bladder 120 can be within a range of 10 cmH2O to 50 cmH2O (±5 cmH2O). Thus, the cuff 110 and bladder 120 can operate at different pressure ranges. The pressure controller 906 also determines, such as through user input or default settings, how often to measure and adjust the pressure in the cuff 110 and bladder 120.

[0075] The pneumatic system 920 includes a first pneumatic path for the bladder 120, e.g., including a first air pump 922a and a release valve 924a, fluidly coupled to the bladder 120 via an output port 926a, a pilot balloon 124, and a lumen 112. The pneumatic system 920 further includes a second pneumatic path for the cuff 110, e.g., including a second air pump 922b and a release valve 924b, fluidly coupled to the cuff 110 via an output port 926b, a pilot balloon 126, and a lumen 122. While two air pumps 922a, 922b are described herein, a single air pump including a valve or switch between the two fluid paths may also be implemented. Thus, the pneumatic system 920 includes separate pneumatic paths for fluidly increasing or decreasing the pressure in the cuff 110 and the bladder 120 independently and separately.

[0076] During 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 bladder 120. One of the cuff pressure sensor devices 902 can be positioned on the exterior surface of the cuff 110 to measure the pressure at the tracheal wall. Additional pressure sensor devices may also be implemented. The pressure sensor devices 902, 904 generate and communicate pressure measurements to the pressure controller 906 via wired leads and / or wireless transmitters.

[0077] Regulator system 900 includes a pressure feedback loop in which pressure controller 906 controls air pressure system 920 to separately adjust the pressure in cuff 110 and bladder 120 in response to pressure measurements. Pressure controller 906 signals air pressure system 920 to add or release air to bladder 120 and / or cuff 110. For example, to adjust the pressure in bladder 120, pressure controller 906 can signal air pump 922a to add air to bladder 120 or release valve 924a to release air from bladder 120. In another example, to adjust the pressure in cuff 110, pressure controller 906 can signal air pump 922b to add air to cuff 110 or release valve 924b to release air from cuff 110.

[0078] Regulator system 900 monitors pressure measurements and automatically adjusts the pressure in cuff 110 and bladder 120 to achieve the predetermined pressure setting. Pressure controller 906 may continuously monitor and adjust the pressure in cuff 110 and bladder 120, or may monitor and adjust the pressure at predetermined intervals. Regulator system 900 may further include a visual and / or audible alarm if an unsafe pressure measurement occurs.

[0079] 10A-10D illustrate an embodiment of an airway device 100 method for removing soft tissue to establish a patent airway and maintaining a patent airway during a gastroscopy procedure. Referring first to FIG. 10A, a method 1000 of airway device insertion is described. First, at step 1002, airway device 100 is inserted into the patient's throat. A gastroscope can be pre-inserted through scope channel 102. Insertion of airway device 100 at 1002 is followed by positioning airway device 100 at 1004 to position bladder 120 adjacent the patient's larynx and hypopharynx and cuff 110 in the upper esophagus. Positioning of airway device 100 can be facilitated by utilizing a pre-inserted gastroscope as a guide, as will be described in more detail with respect to FIG. 11.

[0080] Once so positioned, in step 1006, bladder 120 is inflated, expanding radially outward until it eventually forms a circular or elliptical ring with an internal lumen. This radially expanding bladder 120 pushes the epiglottis and soft tissue within the hypopharyngeal lumen (and adjacent to the laryngeal opening) toward the periphery, providing a less obstructed airway to the trachea. The internal lumen of the inflated bladder 120 provides an unobstructed airway to the patient's trachea.

[0081] Although a bladder 120 is described herein, other mechanisms can be employed to push the epiglottis and other soft tissues toward the anterior wall of the hypopharynx. Although an inflatable bladder 120 is described herein, other mechanisms can be employed to push the epiglottis and other soft tissues toward the anterior wall of the hypopharynx during a gastric procedure. For example, a circular or oval plastic or rubber ring may be attached to the outside of the scope channel 102 by a hinge. The ring may lie relatively flat against the scope channel 102 during insertion. The hinge can then be actuated after insertion of the airway device 100 to deploy the ring, which then pushes the epiglottis and other soft tissues toward the anterior wall of the hypopharynx. Another mechanism may include a thin, rectangular rubber or plastic member attached by a hinge to the scope channel 102. When deployed by 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 toward the anterior wall of the hypopharynx during gastric procedures.

[0082] At 1008, the cuff 110 is inflated at the proximal esophagus to create a seal between the cuff 110 and the esophageal wall. The seal, in some embodiments, is watertight. The inflated cuff 110 helps maintain separation between the digestive tract and the airway. For example, the presence of the cuff 110 helps prevent stomach contents from spilling into the airway. Additionally, the cuff 110 helps eliminate the possibility of inadvertently spilling irrigation fluid (used to cleanse the gastroscope) into the airway, such as during insertion or removal of the airway device 100.

[0083] 10B illustrates one embodiment of a method 1010 for maintaining airway device 100 during a procedure. After insertion and inflation, the endoscopic procedure is performed as usual. During the procedure, the pressures within cuff 110 and bladder 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 traumatizing the esophageal wall. Additionally, bladder 120 is maintained within a second predetermined pressure range, so that bladder 120 effectively holds the epiglottis and soft tissue toward the periphery of the hypopharyngeal lumen without traumatizing the soft tissue or the epiglottis.

[0084] At step 1012, one or more pressure measurements associated with the cuff 110 and the bladder 120 are obtained from one or more pressure sensor devices. The one or more pressure sensor devices may measure esophageal wall pressure (e.g., pressure exerted by the cuff 110 on the wall of the esophagus). In another example, the one or more pressure sensor devices may measure pressure exerted by the bladder 120 on soft tissue in the hypopharynx or the epiglottis. The one or more pressure sensor devices may measure pressure within the bladder 120 and / or the cuff 110. These pressure measurements may be determined periodically or continuously.

[0085] Using these pressure measurements, it is determined (e.g., by pressure controller 906) whether the pressure measurement associated with bladder 120 is within a first predetermined range at 1010 and / or whether the pressure measurement associated with cuff 110 is within a second predetermined range at 1014. If the pressure measurements are within the predetermined ranges, method 1000 continues to periodically or continuously monitor pressure for cuff 110 and / or bladder 120.

[0086] If the pressure at the esophageal wall or the cuff is greater than or less than a first predetermined pressure range, the pressure in the cuff 110 is adjusted in step 1016. Also, if the pressure exerted by the bladder 120 or the intra-bladder pressure is greater than or less than a second predetermined pressure range, the pressure in the bladder 120 is adjusted in step 1016. These steps can be performed at preset intervals or continuously. Thus, the pressures in the cuff 110 and the bladder 120 are controlled separately using separate air pressure paths.

[0087] 10C illustrates a method for removing airway device 100. At the conclusion of the gastroscopy procedure, the gastroscope is withdrawn from scope channel 102 at 1022, and cuff 110 and bladder 120 are deflated at step 1024. Airway device 100 is then removed from the patient's throat at 1026.

[0088] FIG. 10D illustrates one embodiment of a method 1030 for positioning the airway device 100 in a patient in more detail. Insertion of the airway device 100 is paramount given the delicate nature of the upper aerodigestive tract and the limited space available in the pharynx and larynx. The airway device 100 is preloaded with a gastroscope at step 1032 by inserting the gastroscope through the scope channel 102. The airway device 100 is slid over the distal tip of the gastroscope so that the gastroscope insertion section is long enough to be exposed. The gastroscope is then introduced into the patient and advanced into the proximal esophagus at step 1034. At 1036, the gastroscope is inserted into the hypopharynx / proximal esophagus, and the airway device 100 is advanced while holding the gastroscope firmly in place until the tip of the scope channel 102 is visible through the tip of the gastroscope. This ensures that the cuff 110 of the scope channel 102 is properly positioned within the proximal esophagus. Once so inserted, the airway device 100 is stabilized by inflating the cuff 110 .

[0089] In one embodiment, scope channel 102 comprises a transparent or translucent material that allows bladder 120 to be visualized with a gastroscope. The gastroscope may be retracted into the scope channel to ensure proper placement of bladder 120. This step may be performed before and / or after inflation of bladder 120.

[0090] Airway device 100 offers several advantages that facilitate the insertion process. First, the bulk of airway device 100 is minimized through its compact design. For example, outer tube 130, which is the conduit for airflow, is configured to house 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.

[0091] Second, the inflated bladder 120 is in a deflated state during introduction of the device into the patient. In the deflated state, the bladder 120 collapses and folds under the cover 106 before introduction. With bladder volume greatly minimized, insertion of the airway device 100 is greatly facilitated. The smooth device surface made possible by providing the bladder cover 106 to house the bladder 120 allows for easy sliding of the airway device 100. Without such provision, the bladder 120, even when deflated, would create an uneven surface that could potentially catch on the upper edge of the epiglottis, causing the epiglottis to fold downward and block the laryngeal inlet. Blockage of the laryngeal inlet can have catastrophic consequences, even death. To avoid these unforeseen events, the airway device 100 includes a bladder cover 106 that simultaneously covers the bladder 120 and creates a smooth surface.

[0092] Third, the introduction and advancement of the airway device 100 is facilitated by utilizing a pre-inserted gastroscope as a guide. Successful insertion of an instrument into the upper GI tract requires, above all else, a clear pathway. This step is difficult to accomplish when the patient is under deep sedation, as the laryngopharyngeal structures relax and collapse, resulting in complete or partial obstruction of the airway. The novel apparatus and methods disclosed herein ensure successful introduction of the airway device 100 into the upper aerodigestive tract.

[0093] FIG. 11 illustrates one embodiment of an airway device method for delivering oxygenated air and maintaining patient ventilation during a gastroscopy procedure. In this embodiment, the airway device 100 includes at least the outer tube 130 and airway adapter 150 described herein. The airway device 100 may also include a bladder 120 and / or a cuff 110. The airway adapter 150 includes a tubular port 154 configured and sized for connection to a ventilator or other oxygen delivery source. The airway adapter 150 is attached to the outer tube 130, creating a fluid connection via a sealed airflow passageway 310 with an intraluminal space 320 between the scope channel 102 and the outer tube 130. The flow of oxygenated air to the patient's lungs is enhanced by inflating the bladder 120, which removes soft tissue, resulting in a patent airway passageway. If necessary, ventilator-assisted ventilation can be achieved by connecting the tubular port 154 of the airway adapter 150 to a ventilator. The oxygenated air flows through a sealed air flow passageway 310 into the intraluminal space 320 .

[0094] Method 1100 includes inserting and positioning airway device 100 in the patient's throat at 1102. Cuff 110, if present, is positioned in the upper esophagus and inflated at 1104. Bladder 120, if present, is also positioned adjacent the patient's larynx and hypopharynx and inflated at 1104. At 1106, 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, airflow is maintained at 1108 through intraluminal space 320 and into the patient's trachea. At the conclusion of the procedure, the oxygen source is disconnected from airway adapter 150 and airway device 100 is removed from the patient at 1110.

[0095] The airway device 100 can have various embodiments depending on the patient's needs. For example, if the patient does not require respiratory assistance, the additional airway adapter 150 may not be necessary. In another embodiment, the scope channel 102 may include a cuff 110 to prevent gastric contents or irrigation fluid from leaking into the trachea, but may not include a bladder 120. In another embodiment, the scope channel 102 may include a bladder 120 to secure an airway during a medical procedure, but may not include a cuff 110.

[0096] The esophageal cuff 110 prevents gastric reflux by mechanically blocking the reflux of gastric contents into the pharynx and larynx. The inflated bladder 120 retracts soft tissue and / or the epiglottis from the center to the periphery of the hypopharynx adjacent to the laryngeal opening, forming a circular or oval ring configured to clear the patient's airway. Additionally, a central lumen 410 in the inflated bladder 120 provides an unobstructed airway to 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 to the intraluminal space 320 between the scope channel 102 and the outer tube 130. The passage 310 can be strengthened by connecting the airway adapter 150 to an oxygen source. The airway device 100 offers many advantages in various configurations.

[0097] As used herein, the terms “operable to” or “configurable to” indicate that an element includes one or more of circuits, instructions, modules, data, input(s), output(s), etc., for performing the described or required corresponding functions, and may further include inferred couplings to one or more other items for performing the described or required corresponding functions. Also, as used herein, the terms “coupled,” “coupled to,” “connected to,” and / or “connecting” or “interconnecting” include direct connections or links between nodes / devices, and indirect connections between nodes / devices through intervening items. Furthermore, as used herein, an inferred connection (i.e., when one element is connected to another element by inference) includes direct and indirect connections between the two items, as well as “connected to.” As may be used herein, the terms "substantially" and "approximately" provide an industry-accepted tolerance for corresponding terms and / or relativity between items.

[0098] It is noted that aspects of the present disclosure may be described herein as a process, which is depicted as a schematic, a flowchart, a flow diagram, a structure diagram, or a block diagram. While a flowchart may describe operations as a sequential process, many of the operations may be performed in parallel or concurrently. Also, the order of operations may be rearranged. A process terminates when an operation is completed. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination corresponds to a return of the function to the calling function or the main function.

[0099] Various configurations of the disclosure described herein can be implemented in a variety of systems and devices without departing from the present disclosure. It should be noted that the foregoing aspects of the disclosure are merely examples and should not be construed as limiting the present disclosure. The description of the aspects of the disclosure is intended to be illustrative and not limiting of the scope of the claims. As such, the present teachings can be readily applied to other types of devices, and many alternatives, modifications, and variations will be apparent to those skilled in the art.

[0100] In the foregoing specification, certain representative embodiments have been described with reference to specific examples. However, various modifications and changes can be made without departing from the scope of the present invention, as set forth in the appended claims. The specification and figures are illustrative, not limiting, and modifications are intended to be included within the scope of the present invention. Accordingly, the scope of the present invention should be determined by the appended claims and their legal equivalents, rather than merely by the examples described. For example, the components and / or elements recited in any apparatus claim may be assembled or otherwise operatively configured in various permutations, and accordingly are not limited to the specific configurations recited in the claims.

[0101] Furthermore, although certain benefits, other advantages, and solutions to problems have been described above with respect to particular embodiments, any benefit, advantage, solution to a problem, or any element that may cause or make more pronounced any particular benefit, advantage, or solution, should not be construed as a critical, necessary, or essential component or ingredient of any or all of the claims.

[0102] As used herein, the terms "comprise," "comprises," "comprising," "having," "including," "includes," or variations thereof, are intended to refer to a non-exclusive inclusion, and a process, method, article, composition, or apparatus consisting of a list of elements may include not only those elements listed, but may also include other elements not expressly listed in or inherent to such process, method, article, composition, or apparatus. Other combinations and / or modifications of the above-described structure, arrangement, application, proportions, elements, materials, or components used in the practice of the invention, in addition to those not specifically described, may be changed or otherwise specifically adapted to particular environments, manufacturing specifications, design parameters, or other operating requirements without departing from its general principles.

[0103] Furthermore, reference to an element in the singular is not intended to mean "one and only one" unless otherwise specified, but rather "one or more." The term "some" refers to one or more unless otherwise specified. All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. Claim elements are not intended to be construed as "means-plus-function" type elements 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, using the phrase "step for."

Claims

1. A scope channel configured for insertion into the proximal part of the patient's esophagus, An inflatable cuff positioned in the distal portion of the scope channel, which is inserted into the proximal portion of the patient's esophagus, and the scope channel is positioned within the internal opening formed by the inflatable cuff; The scope channel comprises an inflatable bladder positioned proximal to the inflatable cuff, the inflatable bladder configured to be positioned substantially proximal to the patient's esophagus such that the inflatable cuff and the inflatable bladder do not overlap, In its inflated state, the inflatable bladder forms a ring having an outer circumference and an inner circumference, and the ring is positioned substantially in front of the scope channel. A medical device wherein the rear portion of the outer circumference of the ring is attached to the front surface of the distal portion of the scope channel, the inner circumference of the ring forms an internal bore, the front portion of the outer circumference of the ring extends outward at a close angle from the front surface of the scope channel, the front portion of the outer circumference of the ring is configured to contact the epiglottis of the patient and retract from the center to the periphery of the patient's hypopharynx, the internal bore of the ring is configured to form an air passage allowing air to pass into the patient's trachea, and the ring is located outside and in front of the scope channel.

2. The medical device according to claim 1, wherein when the inflatable bladder is in a deflated state, the ring and the inner hole of the ring are crushed and folded to facilitate insertion.

3. The medical device according to claim 1, wherein when the inflatable bladder is in an inflated state, the inner bore of the ring is positioned between the retracted epiglottis and the front surface of the distal portion of the scope channel, providing an air passage to the trachea.

4. The scope channel further comprises a bladder base configured to attach the rear portion of the outer circumference of the ring to the front surface of the distal portion of the scope channel, and the bladder base is The rear surface of the bladder base coupled to the front surface of the distal portion of the scope channel, The front surface of the bladder base is connected to the rear portion of the outer circumference of the ring. A medical device according to claim 3, including the medical device described in claim 3.

5. The bladder base comprises a recess formed within the bladder base, extending to the front surface of the bladder base, configured to hold the inflatable bladder in a contracted state along the transverse axis of the bladder base, The present invention further comprises a cover attached to the distal portion of the bladder base by a spring hinge, the cover extending along the upper part of the recess and covering the inflatable bladder within the bladder base when the inflatable bladder is in a deflated state, The proximal end of the cover is configured to open in response to the upward force exerted by the inflatable bladder during inflation, allowing the inflatable bladder to deploy. After the inflatable bladder is deployed, the cover extends over the recess through the lower part of the inner hole of the ring of the inflatable bladder in its inflated state, by the recoil of the spring hinge, the medical device according to claim 4.

6. The medical device according to claim 5, wherein the recess in the bladder base is configured to hold the front and rear portions of the outer circumference of the ring of the inflatable bladder in a contracted state, and the cover is configured to cover the recess containing the inflatable bladder in a contracted state.

7. The medical device according to claim 1, wherein the inflatable cuff expands radially from the scope channel when inflated.

8. The medical device according to claim 7, wherein the inflatable cuff is configured to form a seal with the wall of the proximal part of the esophagus when inflated.

9. A first expansion lumen coupled to the aforementioned expansion bladder, The second lumen coupled to the inflatable cuff, The medical device according to claim 7, further comprising:

10. Further comprising a pressure regulator, the pressure regulator is The first expansion lumen is used to adjust the first pressure within the inflatable bladder. The medical device according to claim 9, configured to use the second expansion lumen to adjust a second pressure within the inflatable cuff.

11. The inflatable bladder further comprises an outer tube located proximal to the scope channel, distal to the proximal opening of the scope channel, which forms an internal space that accommodates at least a portion of the scope channel. The inner wall of the outer tube and the outer wall of the scope channel form a lumen space. The medical device according to claim 1, wherein the luminal space provides a passage for airflow into the hypopharynx of the patient and for airflow into the inner bore of the ring of the inflatable bladder in the trachea of ​​the patient.

12. A first proximal opening portion that forms a seal around the proximal opening of the scope channel, A distal opening that forms a seal around the outer tube, A second proximal port configured to connect to a ventilator or oxygen delivery tube, A sealed air passage extends from the second proximal opening to the lumen space and provides airflow from the second proximal opening to the lumen space, and The medical device according to claim 11, further comprising an adapter including an adapter.

13. A medical device, An airway adapter configured to be positioned outside the patient, and configured to be connected to a ventilator or oxygen delivery tube, A scope channel coupled to the airway adapter, configured for insertion into the hypopharynx and esophagus of a patient, An outer tube coupled to the airway adapter, surrounding the scope channel, and extending from the distal end of the airway adapter to at least the middle portion of the scope channel in the hypopharynx of the patient, having a larger diameter than the scope channel, forming a luminal space between the inner front wall of the outer tube and the outer front wall of the scope channel, the luminal space forming an air passage, and the luminal space being configured to allow air to flow from the ventilator or oxygen delivery tube connected to the airway adapter to the hypopharynx of the patient, An inflatable bladder, attached to the front surface of the distal portion of the scope channel and configured to be positioned substantially proximal to the esophagus and distal to the luminal space, wherein, in the inflated state, the inflatable bladder forms a ring extending outward from the front surface of the scope channel at a substantially close angle, the ring forms an internal bore extending substantially outward from the front surface of the scope channel, the ring of the inflatable bladder is configured to contact and exert force on the epiglottis in the hypopharynx of the patient, the internal bore of the ring forms an air passage outside and above the front surface of the scope channel, and the internal bore is configured to allow air to flow from the luminal space into the trachea of ​​the patient, An inflatable cuff is mounted distal to the inflatable bladder on the scope channel and configured to be positioned within the patient's esophagus such that the inflatable cuff and the inflatable bladder do not overlap, wherein the scope channel is positioned within the internal cavity formed by the inflatable cuff, and when inflated, the inflatable cuff expands radially from the scope channel to provide a seal against the patient's esophageal wall. A medical device equipped with the following features.

14. Further comprising a bladder base, the bladder base is The rear surface coupled to the front surface of the distal portion of the scope channel, The front surface is connected to the rear portion of the outer periphery of the aforementioned inflatable bladder, A recess on the front surface of the bladder base, wherein the inflatable bladder folds into the recess in a contracted state, A cover attached by a spring hinge to the distal portion of the front of the bladder base, the cover extending along the upper part of the recess and covering the retracted inflatable bladder folded within the recess, and A medical device according to claim 13, including the medical device described in claim 13.

15. The inflatable bladder applies force to the proximal portion of the cover during inflation to open the cover, The medical device according to claim 14, wherein when the inflatable bladder is inflated, the cover returns to a closed position through the inner bore of the inflatable bladder by the recoil of the spring hinge, covering the upper part of the recess.

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