Intubating ventilatory face mask

Details Intubating ventilatory face mask Intubating ventilatory face mask

2001-10-25

2004-09-21

Bennett, Henry (Department: 3743)

Surgery

Respiratory method or device

Means placed in body opening to facilitate insertion of...

C128S205250

Reexamination Certificate

active

06792943

ABSTRACT:

FIELD OF THE INVENTION
The present invention is related generally to medical devices. More specifically, the present invention relates to face masks which can find one use in delivery of anesthesia and respiratory gases. The present invention includes a standard breathing circuit port and a variable inside diameter port which can be used to form an airtight seal about fiberoptic laryngoscopes and endotracheal tubes.
BACKGROUND OF THE INVENTION
The use of endotracheal tubes or breathing tubes is the preferred and standard method for administering general anesthesia for major surgical procedures. The endotracheal tube typically has a distal end carrying an inflatable balloon disposed about the circumference. The balloon can be inflated to form an air tight seal within the trachea once the endotracheal tube distal end is in place. The proximal end of the endotracheal tube typically has a standard connector, having nominally ⅜
th
inch inside diameter and ⅝
th
inch outside diameter. The endotracheal tube may be put into position by an anesthesiologist, the distal balloon inflated, and the oxygen and anesthesia gases delivered to the patient. The endotracheal tube is typically put into position after the patient has been put under, to avoid patient gagging on the inserted endotracheal tube.
Some patients present “difficult airway situations.” These situations make it difficult to place the endotracheal tube. Examples of difficult airway situations include patients having short muscular necks, receding lower jaws with obtuse mandibular angle, limited cervical spine mobility, and poor mobility of the mandible. Extremely obese patients may also present a difficult airway situation. In a difficult airway situation, an anesthesiologist may be forced to use a flexible fiberoptic scope to identify or locate the proper position for the endotracheal tube, followed by coaxially sliding the endotracheal tube over the pre-positioned fiber optic tube.
One exemplary scenario illustrates one set of problems addressed by the present invention. A patient is wheeled into an emergency room, in critical condition, having been involved in an automobile accident. The patient has significant internal injuries with internal bleeding, requiring immediate surgery. The patient's neck has been fractured in the accident, and significant movement of the neck may render the patient quadriplegic for the remainder of their life.
If the anesthesiologist tilts the head backward to insert the breathing tube to begin general anesthesia, the patient may be rendered paraplegic. If the anesthesiologist does not insert the breathing tube, general anesthesia, and therefore surgery, cannot be begun. One solution is to perform a tracheotomy. This can include cutting the patient's neck and inserting an endotracheal tube through the front of the neck. While the patient's skin may be numb, the cutting will generally be performed prior to the administration of general anesthesia, while the patient is awake. This is a less than optimal situation for the still awake, and injured patient.
One method to address the above situation includes inserting a fiberoptic laryngoscope to identify the trachea, followed by the insertion of the endotracheal tube over the laryngoscope. If the fiberoptic laryngoscope were inserted with no sedation or general anesthesia, the patient's gag reflex and general panic may result in the patient gagging, biting through the fiberoptic laryngoscope, and even vomiting, with the possible aspiration or inhalation of vomit and resultant suffocation. All this is occurring prior to proper placement of the endotracheal tube, before the required major medical procedure has even begun.
In order to deal with the above mentioned problems, the anesthesiologist may be required to sedate the patient simply to insert the fiberoptic tube and/or endotracheal tube. When the patient is sedated, the reaction of the patient may be highly variable and unpredictable. A dose of a sedative, for example, sodium pentathol, may leave one patient awake and thrashing, while causing the complete cessation of breathing in another patient. If too low a dose is initially given, the time elapsed before placement of the breathing tube and the initiation of surgery is increased. If too high a dose of sedative is given to the patient, breathing will stop, with death eminent unless positive pressure ventilation can be begun. Positive pressure ventilation through the endotracheal tube could be initiated if the endotracheal tube were in place. Unfortunately for the patient, that is not the case.
The anesthesiologist facing this difficult situation may thus be faced with a patient thrashing about while the fiberoptic probe is inserted into his trachea, or faced with the situation where the patient has ceased breathing and has no endotracheal tube yet in place.
General anesthesia gases may be delivered through a standard, soft sealing face mask. However, this standard face mask must be removed in order to insert the fiberoptic laryngoscope, thereby ceasing delivery of the anesthesia gas. If the patient has ceased breathing due to the sedative previously administered, a standard face mask may be used to provide positive pressure ventilation, forcing enriched oxygen gases into the patient's lungs. However, when the standard face mask is removed, the patient no longer breathes, and the blood oxygen level drops or desaturates, along with any delivered general anesthesia gas. Once the standard face mask is removed, the anesthesiologist is under intense time pressure to properly position the fiberoptic laryngoscope and the endotracheal tube. The time required to properly place the fiberoptic laryngoscope and the endotracheal tube is time in which the patient is not receiving any general anesthesia gas and is not receiving any oxygen. If the procedure is too difficult and requires too much time, the patient may awaken due to lack of anesthesia gases and/or approach death due to lack of oxygen.
What would be desirable is a sealing face mask which permits simultaneous positive pressure ventilation, delivery of anesthesia gases, and also allows simultaneous placement of medical shafts such as fiberoptic probes and endotracheal tubes, together with maintenance of positive pressure and delivery of oxygen to the patient. What would be advantageous is a face mask which permitted simultaneous introduction of numerous diagnostic and therapeutic devices into the mouth and nose of a patient concurrent with the delivery of positive pressure ventilation.
SUMMARY OF THE INVENTION
The present invention provides intubating ventilatory face mask apparatus and methods. One face mask includes a central region surrounded by a peripheral soft seal region. A breathing circuit port can be disposed on the mask as well as an instrument port. The instrument port can have a controllably variable or adjustable inside diameter. The instrument port inside diameter can be controlled through the increase and decrease of the inside diameter of the sealing wall of an instrument cuff or envelope disposed within the instrument port. In one mask, an inflatable envelope or balloon material is disposed within a short, tubular, instrument port lip or wall. The cuff can be inflated and deflated through an attached valve or port. One mask is adapted to receive a standard syringe to inflate and deflate the instrument port cuff. A snap fit lid can be provided for sealing the instrument port when its use is not required. The inside diameter of the instrument port is preferably adjustable between a size small enough to form an air tight seal about a fiber optic laryngoscope, and a size large enough to allow passage of the proximal connector of an endotracheal tube. In one embodiment, the inside diameter of the instrument port is controlled through an iris mechanism, analogous to that found in camera lenses.
One mask has an internal volume of between about 100 and 150 cubic centimeters. The instrument port is preferably centrally located with respect to the apex

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