Intubation device

Details Intubation device Intubation device

1999-02-23

2001-07-10

Lewis, Aaron J. (Department: 3761)

Surgery

Respiratory method or device

Respiratory gas supply means enters mouth or tracheotomy...

C128S207150, C128S206290, C128S200260

Reexamination Certificate

active

06257236

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device, for the placement of an endotracheal tube into the trachea of the anesthetized patient, comprising a stylette/introducer which is placed into the trachea of said patient through a port in an anesthesia face mask, and then passing an endotracheal tube over the stylette, thereby securing the airway. The major advantage of this system is that the patient is ventilated during the most time consuming phase of the process, that is, the identification of the trachea and the passage of the stylette into it.
2. Prior Art
The necessity and advantage of endotracheal intubation in the application or anesthesia, and for pulmonary therapy is well documented and widely accepted. Intubation of the trachea was first accomplished in 1878 and since that time, the use of tracheal intubation in the patient with a difficult airway has been the anesthetist's most problematic situation.
Intubation of the trachea is necessary to protect a patient's airway during general anesthesia and to provide a way to ventilate the patient using positive pressure when the patient cannot adequately ventilate himself or herself. Intubation allows the use of positive pressure ventilation, continuous positive airway pressure, and positive end expiratory pressure.
Endotracheal intubation is now the standard of care in most operations, and its use now allows the introduction of carbon dioxide gas into the peritoneal cavity which facilitates the use of laporoscopic instrumentation to accomplish “band aid surgery” from within the peritoneal cavity rather than invasively, via large incisions, from the outside of the body.
The common practice during intubation is to cease ventilating the patient, insert the laryngoscope, visualize the opening of the trachea, and then, under direct vision, insert the endotracheal tube. After this is done, ventilation is re-instituted. In the instance of the difficult airway, where the tracheal opening cannot be visualized due to anomalies occurring in the structure of the airway, the practitioner may choose to utilize the fiberoptic laryngoscope to visualize the tracheal opening and to help insert the endotracheal tube. In order to accomplish this, the medical practitioner must cease ventilating the patient in order to use a fiberoptic laryngoscope to visualize the opening of the trachea. During this time the patient is not ventilated. The safety of the visualization of the tracheal opening in this manner, then, depends on the rapidity with which the practitioner can visualize the opening, and insert the endotracheal tube.
Various patents have been issued for devices which have attempted to deal with the problematic period of non-ventilation during the process of intubation. U.S. Pat. No. 5,197,463, SINGLE STAGE SEAL ADAPTOR FOR ENDOTRACHEAL INTUBATION AND REMOVAL ANESTHESIA MASK typifies these attempts to solve this problem. This consists of a “T” piece located on a specially designed mask which allows the take down of the top of the inlet to allow the passage of an endotracheal tube. U.S. Pat. No. 5,694,929 utilizes a guide which is an integral part of the anesthesia mask. The guide fits in the mask and enters the patient's mouth and, being a hollow tube, serves as a guide for the fiberoptic laryngoscope and endotracheal tube. While this device may allow the practitioner to intubate with the minimal disruption of ventilation, it appears that the connecting port of the ventilating endotracheal tube would have to be removed to fascilitate removal of the mask and airway from the tube which is placed through them. Care would have to be taken not to pull on the pilot tube of the endotracheal tube when this was being done. With the present invention, the only device in the patient's airway when the endotracheal tube is inserted, is the stylette/introducer, which pulls out of the airway from inside the endotracheal tube, once the airway is secure. This manipulation is simpler and more direct than other means necessary under the current art.
U.S. Pat. No. 5,623,921, known as the Laryngeal Mask Airway, is a device which, when placed within the patient's oropharynx, forms a seal around the opening of the trachea at the location of the superior larynx. The LMA, as it is widely known, does not completely seal the airway from aspirate. Another limitation is that only low pressures, less than 20 centimeters of water, can be used to ventilate the patient. This limitation prevents the usage in obese patients, or those surgical cases where greater pressures may be anticipated to be necessary.
Apparatus such as the Blachly BITE BLOCK ASSEMBLY, U.S. Pat. No. 4,112,936 and the Blachly OROPHARYNGEAL AIRWAY AND BITE BLOCK ASSEMBLY AND METHOD FOR CLOSED PULMONARY VENTILATION, U.S. Pat. No. 4,270,531 provide gas seal and the depth adjustability of the Northway-Meyer apparatus, but neither of the Blachly devices allows the placement of an endotracheal tube through the apparatus.
The ELAM MASK BREATHING SYSTEM U.S. Pat. No. 4,449,526 device does accommodate a fiberoptic laryngoscope and it does not accommodate an endotracheal tube. It's use is restricted to ventilation via the natural airway, such as in resuscitation.
BRIEF SUMMARY OF THE INVENTION
The present invention is a simple, practical device which utilizes four components; 1) a flexible fiberoptic laryngoscope/bronchoscope (FFLB); 2) an anesthesia mask with a special port located in the body of the mask; 3) one of two different sized introducer/stylettes; and 4) a thread retrieving device.
The fiberoptic laryngoscope may be any one of the number of currently available fiberoptic laryngoscopes or bronchoscopes, used in the medical field today.
The mask is in the configuration of a standard anesthesia mask commonly used currently in the practice, with the addition of the side port, located on either side of the circuit connecting port, over the position of the mouth. This pluggable port, with a distensible membrane, serves as an opening through which the FFLB may be introduced into the patient's airway, and into the trachea. The membrane of the port is a flexible dipharam-like cover, e.g. of a soft plastic material, such as silastic, having a skirt protion adapted to stretch over a lip of the main body of the port, and a cover portion with a central opening for receiving and allowing passage of the FLB/introducer assembly. The means of obturating the opening in the cover may comprise a slug of hard rubber or the like.
The introducer/stylettes are two. Both are tubes though which the FFLB is initially place before it is inserted into the port. Preferably the introducer/stylette, also referred to as the introducer, is a semi rigid plastic tube. The inside diameter of the introducer allows a slight clearance in the introducer around the FFLB. Preferably, the inside diameter of the introducer is about 1 to 1.5 mm larger than the diameter of the FFLB, approximately five to six millimeters. The reason there are two lenghts of stylettes is that there are various lengths of fiberoptic laryngoscopes. For the shorter fiberoptic laryngoscopes, the length of the introducer is sufficient to allow the introducer to be slid up to the proximal end of the FFLB so that its presence does not interfere with the practitioner as the FFLB is directed to, and placed within the trachea. Preferably the length of the introducer is about 35 cm. The distal end of the introducers are rounded and diagnonally cut, having no sharp edges. The proximal end of the shorter introducer has two apertures through which a length of silk thread, preferable a silk thread about forty inches long, can be threaded. The proximal end of the longer introducer is plain, without apertures.
The hook is constructed of stiff wire, of suitable medical material. It has a small hook on the distal end enabling it to be advanced through the inside diameter of an endotracheal tube, and a larger loop on the proximal end, allowing the practitioner's finger to go through the loop to aid

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