Surgery – Respiratory method or device – Means placed in body opening to facilitate insertion of...
Reexamination Certificate
1998-06-25
2002-02-26
Lewis, Aaron J. (Department: 3761)
Surgery
Respiratory method or device
Means placed in body opening to facilitate insertion of...
C128S207140, C128S205230
Reexamination Certificate
active
06349720
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to endotracheal intubation devices, and more particularly, an endotracheal tube having an apparatus coupled therewith for acoustically indicating the placement of the distal end of the tube within a person's body to the unaided ear of a health care provider.
BACKGROUND OF THE INVENTION
Methods and apparatus for intubating the trachea of a patient are well-known in the art. In this regard, an endotracheal tube (hereinafter “ETT”) is typically inserted through the mouth and into the trachea of a patient, and is ideally positioned such that the distal end thereof is placed just above the carina (i.e., the central ridge formed by the bifurcation of the trachea into the left and right bronchus). Introduction of the ETT into the body may alternatively be accomplished through nasotracheal intubation. In rare acute emergency situations, the ETT may be introduced directly into the trachea via tracheostomy or tracheotomy.
Ideally, endotracheal intubation via any of the aforementioned techniques should not be performed without the requisite tools, the minimum tool being a stethoscope, and experience to use the same. In this regard, endotracheal intubation may be complicated by inadvertent insertion of the ETT into the esophagus, or past the carina into one of the right primary bronchus or the left primary bronchus. Also, post placement movement of the distal ETT tip past either the carina or above the vocal cords due to patient or ventilator tube movement, or mucus blockage of the ETT lumen can occur over time. In all such scenarios, the patient is ineffectively ventilated which may result in severe medical complications, including death.
In an effort to avoid the aforementioned complications, techniques have been developed to aid clinicians in the determination of the location of ETT. Currently, clinical techniques utilized to evaluate ETT location include stethoscopic evaluation of the airway, breath, and epigastric sounds, respiratory system compliance measurements, detection of asymmetrical chest excursion, chest compression techniques, palpitation of the ETT cup over the extrathoratic trachea, electromagnetic detection devices, ultrasonic techniques, optical techniques, carbon-dioxide measurements, suctioning devices, and chest x-rays.
In addition to the aforementioned clinical techniques, there has been developed a variety of methods and apparatus for guiding and positioning ETTs within the body of a patient. Exemplary of such prior art devices include those disclosed in U.S. Pat. No. 5,445,144 to Wodicka, et al., which discloses an apparatus for acoustically guiding a distal end of a tube within a body which utilizes a waveguide coupled to the distal end of a tube with a speaker coupled therewith for generating an incident sound pulse in the waveguide which propagates into the body of the patient. A microphone coupled to the waveguide between the speaker and the tube is provided to detect sound pulses moving past the microphone and the waveguide from the incident sound pulse and from reflected sound pulses from within the body. Such system further includes means for processing the sound pulses detected by the microphone to guide insertion of the proximal end of the tube within the body. Other similar devices are disclosed in U.S. Pat. No. 5,560,351 to Gravenstein, et al.; U.S. Pat. No. 5,257,636 to White; U.S. Pat. No. 4,344,436 to Kubota; and U.S. Pat. No. 4,431,005 to McCormick.
In emergency situations occurring in remote locations, and particularly a battlefield, it is impractical for such aforementioned techniques to be performed. In this regard, the medical devices necessary to perform such techniques cannot be practically deployed in the context of a battlefield situation. Additionally, such clinical techniques necessarily must be performed by trained clinical personnel, which will likely be unavailable during such situations.
Ironically though, it is precisely those types of battlefield situations where endotracheal intubation must be performed to establish an emergency airway. Indeed, battlefield casualties can and frequently do experience occlusion of the airways or cessation of breathing, thus giving rise to a medical emergency. In this regard, after 4 to 5 minutes of anoxia, severe or irreversible brain damage is likely. Therefore, prompt establishment of a patent airway via an ETT is essential.
Accordingly, there is a need in the art for an ETT that may be easily and readily utilized to intubate the trachea of a casualty or other medical patient that can further provide an accurate indication of the placement of the distal end of the ETT within the body of the patient. There is additionally a need in the art for such an ETT that can provide an indication of the proper placement thereof by utilizing simple mechanical means which consequently does not rely upon any sophisticated equipment. There is still further a need in the art for an ETT that may be readily implemented by individuals having minimal training and/or experience in endotracheal intubation and ventilator operation.
SUMMARY OF THE INVENTION
The present invention specifically addresses and alleviates the aforementioned deficiencies in the art. Specifically, the present invention is directed to an audio aid for determining the optimum position of an ETT within a patient. According to a first preferred embodiment, the invention comprises a conventional cuffed ETT having distal and proximal ends; the proximal end is the part that remains outside the body. Formed upon the distal end is a mechanical noise maker, which may take the form of a reed, whistle or other like device. The ETT, and more particularly the distal end thereof, is advanced into the trachea or esophagus during endotracheal intubation. Once the distal end of the ETT has been sufficiently advanced such that an airway has been established, air will thus be drawn into and expelled from the ETT as the patient inhales and exhales. Such proper positioning will thus cause the mechanical noise-making device formed upon the distal end of the ETT to make audible sound to thus indicate to a caregiver that the ETT has been properly positioned within the trachea. Proper placement will be indicated by the sound being heard from both sides of the chest cavity equally and not from the stomach. This sound is heard with the unaided ear of the doctor, medic or nurse.
In a second preferred embodiment, the invention comprises the combination of a conventional cuffed ETT having distal and proximal ends and an insertion rod, the latter also having distal and proximal ends. The insertion rod further includes an electronic noise maker formed on the distal end thereof that produces an audible signal to assist the placement of the ETT within the trachea of a patient.
It is therefore an object of the present invention to provide an audio aid for the unaided ear to rapidly and properly position an ETT within a patient's trachea to provide a more intuitive aid in the proper positioning of the ETT than prior art systems.
Another object of the present invention is to provide an audio aid for properly positioning an ETT within a patient's trachea which can be used with conventional, inexpensive, readily available ETTs.
Another object of the present invention is to provide an audio aid for indicating the proper positioning of an ETT that provides an indication of the proper positioning of the ETT that further allows the patient to be simultaneously ventilated.
Another object of the present invention is to provide an audible aid for indicating the proper positioning of an ETT within a patient's trachea that provides a continuous audible indication as to the proper positioning of the ETT within the patient's trachea.
A still further object of the present invention is to provide an audible aid for indicating the proper positioning of an ETT within a patient's trachea that may be readily and easily used by a medic, or doctor with no special training in the operation of the device.
REFERENC
Integrated Medical Systems, Inc.
Lewis Aaron J.
Stetina Brunda Garred & Brucker
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