Deconstricting airway devices

This continuation in part application claims priority to the co-pending non-provisional application having a Ser. No. of 11/602,918 and a filing date of Dec. 22, 2006, the co-pending non-provisional application having a Ser. No. of 11/602,919 and a filing date of Dec. 22, 2006, the co-pending non-provisional application having a Ser. No. of 11/602,920 and a filing date of Dec. 22, 2006, the co-pending non-provisional application having a Ser. No. of 11/602,921 and a filing date of Dec. 22, 2006, and the co-pending design patent application having a Ser. No. of 29/269,141 and a filing date of Dec. 12, 2006, and all of the aforesaid applications are commonly owned by the same inventor.

The deconstructing airway devices generally relate to respiratory equipment and more specifically to a device that spreads the jaws of a patient to open the patient\'s airway for a medical procedure.

A core skill required in the practice of Anesthesia, Critical Care and Emergency Medicine and increasingly in other specialties such as cardiology that involve invasive procedures in which varying levels of sedation are given to patients is the maintenance of an open airway for spontaneously breathing patients and a patent passage for gases (e.g. oxygen) to allow ventilation in the obtunded and apneic patient. There are a myriad of airway devices to support these skills, all by creating a physical passageway to the hypopharynx and tracheal opening or through the trachea. None of these devices are tolerated by an awake or moderately sedated patient because they touch areas of the oro-naso and hypopharynx that elicit a powerful gagging and coughing reaction.

The patent human airway in which there is adequate and life supporting flow of gas to the lungs depends on the anatomy of the soft tissues of the tongue, palate and pharynx, the bones and joints of the face, and importantly the tone of the muscles embedded and animating these structures. As a person becomes somnolent, sedated or obtunded, tone decreases, the soft tissues collapse, and the mandible drops backward resulting in airway obstruction causing inadequate or no air movement even if the patient is still adequately breathing, with possible hypoxia leading, untreated, to death. This occurs even in sleep and can be pathologic with health consequences in Obstructive Sleep Apnea associated very strongly with obesity. Difficulty maintaining the airway even with very mild levels of sedation is also associated with obesity. Patients who are being anesthetized or deeply sedated will pass through a stage of light sedation both when being sedated and when awakening. This state is dangerous and difficult for the patient won\'t tolerate any standard airways but can obstruct anyway, and this difficulty is dramatically exacerbated by obesity, a condition increasingly common and associated with health needs, resulting in the likelihood of needing medical procedures or surgery.

Skilled airway managers such as anesthesiologists and anesthetists learn maneuvers to allow an air/gas passage to be maintained in the obtunded patient. Beside head and neck positioning, these chin lift and jaw thrust maneuvers take advantage of the unique anatomy of the human temporo-mandibular joint, a true double joint, a rotating ball joint until fully open, then becoming a cam joint as the mandibular condyle slides forward onto a bony shelf in the anterior portion of the joint, dropping the posterior part of the mandible, stretching the soft tissues and creating an air passage. In the airway maneuvers the mouth is not opened but by pulling the chin (in the patient not breathing) or pushing the angle of the jaw (in the breathing patient) the cam joint action is engaged, the hypopharynx is opened and a patent gas passage from the nose though the pharynx is created.

In American Medicine the number of invasive and uncomfortable procedures has been dramatically increasing, often to replace more invasive or surgical procedures that required general anesthesia. These procedures require some level of sedation so they can be tolerated by the patient, and in most institutions anything requiring more than a mild sedative that should not result in airway obstruction is attended by an anesthesia provider because of the consequences of even the slightest slip up in managing the airway. With aging and greater obesity even mild sedation can be dangerous. A device tolerated by an awake patient that would help maintain an open air passage as they are sedated or anesthetized and conversely could be left in the mouth as they awakened, would enhance the safety of sedation, and make many procedures more acceptable with less risk. Such a device may be used by a monitoring clinician other than an anesthesia provider not unlike the bite block used in endoscopy procedures which this device could replace, making not only a passage for the endoscope but helping maintain the airway. Such procedures may be less costly and more convenient to schedule if an anesthesia provider\'s attendance is not mandatory. And such a device might be useful in the management of Obstructive Sleep Apnea.

Generally, the present invention is an easily placed oral device with a soft lining to grip the dental, or alveolar, aches firmly to hold a fixed relationship of a slight angulation between the jaw and the roof of the mouth with a solid connection at the molar end of the arches to gently advance the mandible forward from the maxilla. The invention thus maintains an open air passage to the hypopharynx without touching any part of the mouth but the dental arches and the anterior tongue. The present invention has two arcuate trays upon gently bent connector pillars or buttresses forming a recognizable shape. The buttresses maintain the distance between the two trays.

The present invention has an anterior opening/aperture so it can be placed over objects already in the mouth or objects can be placed though it, such as a suction device to clear secretions. Instruments, such as bronchoscopes, endoscopes, or esophagogastroscopes, may be used within the airway. It can function as a bite block to protect such airways as an endotracheal tube or a larygneal airway. The invention can be placed over an already present endotracheal tube and then left in place until a patient is fully awake such as during emergence and recovery from a general anesthetic. The arches and connecting pillars should be made of a strong material that promotes comfort and is inert in the mouth. It can be used with any oxygen delivery device placed on the face and will be a useful adjunct to mask ventilating the patient during the induction of anesthesia or should the need arise in other circumstances. The airway should be available to in two versions to accommodate teeth or dentures and the edentulous state and still function as well.

The invention\'s design and appropriate sizes allows for use easily, even in emergent circumstances. Because the invention only grips the dental arches, of the mandible and the maxilla, it will not bother or irritate the mouth, oral structures, or pharyngeal structures, or stimulate strong reflexes such as gagging. An alternate embodiment incorporates a firm arch across the two legs of the mandibular component, but the anterior two thirds of the tongue, while quite sensitive to even light touch does not elicit strong reflexes. The firm grip on the dental arches makes the invention an anchor for other oral devices by firmly affixing them to it with a tie.

The present invention is an oral device designed to fit on the dental arches or alveolar ridges of both the maxilla and the mandible of a patient with connecting buttresses, or pillars. The pillars maintain an angular opening between the two arches thus establishing an open oropharynx. The present invention is suitable for use in the conscious, or awake, patient. The present invention incorporates a jaw thrust feature where the mandible of a patient is moved a few millimeters, approximately one to approximately three, frontally or anteriorly. The present invention utilizes the human temporomandibular joint\'s unique transition from a roller hinge joint to a cam joint which further opens the oropharynx but not increasing the angle of the patient\'s mouth further. The present invention has embodiments suitable for those patients with teeth or dentures and those patients without teeth, such as infants and the elderly, often called edentulous.

For most of its range of motion, the human temporo-mandibular joint opens upon a single point similar to a hinge. Approaching full opening, the mandibular condyle slides forward over the cartilaginous meniscus of the joint thus riding up a bony prominence like a cam. This cam opening of the joint further opens the posterior portion of the oropharynx, and in a sense slightly dislocating the jaw. Anesthesiologists and other health care providers take advantage of this anatomy. The providers push the mandible frontally, without opening the mouth, by placing their thumbs or fingers behind the angle of the mandible and gently thrusting forward, a maneuver called the jaw thrust.

The present invention emulates this maneuver by gently and firmly holding the dental ridges and teeth and slightly pushing the mandibular component forward in relation to the maxillary component. This maneuver has not been seen in existing airways found by the Applicant. Combined with partially opening the mouth and its non-gagging design, the present invention may be used in the fully awake patient who then may sleep or be sedated with the invention in place. Further, the present invention could be in place with the patient\'s level of consciousness altered and left in place as the patient awakens and returns to a fully awake state. The present invention can be used in the sedated, anesthetized, or obtunded patient. Unlike existing airway devices, such as the oropharyngeal or nasopharyngeal airways, the present invention can be placed at the beginning of a procedure when the patient is awake. The invention can then be left in the patient until the end of the procedure when the patient awakens and becomes fully aroused. However, the jaw thrust feature need not have the mouth opened to be effective because in the clinical, or manual, maneuver it usually results in a competent airway passage via the nasopharynx.

The present invention can also be used in the obtunded patient. An alternate embodiment of the invention includes an anchoring device, such as a zip or Nye tie, that secures another airway device, such as an endotracheal tube or a laryngeal mask airway, to the invention. The present invention stabilizes the movable components of the human airway and jaws, such as the mandible. By securing another airway device to the invention as during usage with a ventilated patient, the present invention provides a more secure attachment of the other airway device to itself than taping the other airway device to the patient\'s face. The ability of the present invention to secure another airway device has particular utility with the edentulous patients, in whom an endotracheal tube taped to the lip has a great deal of movement which may adversely affect patient ventilation.

The present invention also excludes the ability to stimulate, that is to induce the gagging reflex, of an awake patient. This exclusion maintains a patent upper airway even as a patient becomes somnolent, sedated, or anesthetized. The present invention falls below the tolerance of a fully awake user with intact cranial nerve reflexes. The angle between the upper and lower trays of the invention is generally below 20° but still as wide as possible for maximum benefit, least airway obstruction, to the patient.

The present invention further has a preferred embodiment for patients having teeth or dentures and at least one alternate embodiment for an edentulous, or toothless, patient. The alternate embodiment has a slightly taller and wider foam lining within the trays of the invention. The taller and wider lining holds the invention upon the gums and maintains the same height between the maxillary and mandibular components as the embodiment for the toothed patient.

The present invention, an oral device, has two arches, or trays, that gently hold both the maxillary and mandibular dental arches of a patient in a fixed position angled slightly open but not stimulating any part of the oropharynx thus allowing an awake patient to tolerate the invention. The invention has trays made of a resilient material, such as a soft plastic, and a foam insert to hold the teeth or edentulous arches. The trays conform to the shape of the teeth or edentulous arches along with the maxillary and mandibular anatomy. The trays are spaced apart by buttresses, also called pillars or columns. The present invention can be placed in the mouth by an awake patient. By gently maintaining the mouth slightly open, the invention enhances the patency of the airway. The jaw thrust feature of the invention capitalizes on the unique anatomy of the human temporo-mandibular joint wherein anterior (frontal) movement of only a few millimeters change the joint from a hinge to a cam. The hinge motion and cam motion of that joint remain separate and thus thrusting the mandibular component a few millimeters elevates the mandibular condyle which opens the oropharnyx without gagging the patient, all the while enhancing airway patency. The invention can be used as a clinical airway in awake to sedated to anesthetized patients and in obtunded patients. The invention can be tolerated by more patients until a patient attains a fully awake state. Further, the patient may emplace the invention either for a medical procedure or as an airway support for mitigating OSA.

There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood and that the present contribution to the art may be better appreciated. The present invention also includes sockets for the bale spears and for the back stops. Additional features of the invention will be described hereinafter and which will form the subject matter of the claims attached.

Numerous objects, features and advantages of the present invention will be readily apparent to those of ordinary skill in the art upon a reading of the following detailed description of the presently preferred, but nonetheless illustrative, embodiment of the present invention when taken in conjunction with the accompanying drawings. Before explaining the current embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.