Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...
Reexamination Certificate
2001-08-24
2004-04-27
Lewis, Aaron J. (Department: 3761)
Surgery
Respiratory method or device
Respiratory gas supply means enters mouth or tracheotomy...
C128S207150
Reexamination Certificate
active
06725862
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
This Tracheostomy tube system provides a Tracheostomy tube, Tracheostomy collar, and swivel adapter for measured suctioning of the patient in a non-invasive manner and at a controlled negative suction pressure.
2. Description of the Related Art
A Tracheostomy is an opening through the neck into the trachea through which an indwelling tube may be inserted. An incision is made into the trachea through the neck below the larynx. The opening may be made as an emergency measure or performed as scheduled in an operating room. The incision is made through the skin through the second, third, or fourth tracheal ring. A small hole is made in the fibrous tissue of the trachea, and the opening is then dilated to allow the intake of air.
Airway problems that may require the performance of a Tracheostomy could include tumors, such as cystic hygroma; laryngectomy; infection, such as epiglottitis or croup; subglottic stenosis; subglottic web; tracheomalacia; vocal cord paralysis (VCP); laryngeal injury or spasms; congenital abnormalities of the airway; large tongue or small jaw that blocks airway; Treacher Collins and Pierre Robin Syndromes; severe neck or mouth injuries; airway burns from inhalation of corrosive material, smoke, or steam; obstructive sleep apnea, and foreign body obstruction. In addition, lung conditions that could require a Tracheostomy include a need for prolonged respiratory support, such as Broncho pulmonary Dysplasia (BSD); chronic pulmonary disease to reduce anatomic dead space; chest wall injury; or diaphragm dysfunction. Other conditions include neuromuscular diseases that cause paralysis or weakening of the chest muscles and diaphragm, fracture of the cervical vertebrae with spinal cord injury, long-term unconsciousness or coma, disorders of respiratory control such as congenital central hypoventilation or central apnea, and facial surgery of facial burns.
After undergoing a Tracheostomy procedure because of respiratory disorders, individuals require the use of a Tracheostomy tube assembly connected to a mechanical ventilator to assist their breathing. Today there are three basic indications for a Tracheostomy in a pediatric patient: upper airway obstruction, assisted ventilation, and pulmonary toilet.
There are several different types of Tracheostomy tubes available. The ideal tube should be soft, pliable, easy to clean and maintain, and available in a variety of sizes and lengths. The choice of type and size of tube should be based on the indication for the procedure.
U.S. Pat. No. 4,510,933 by Wendt et al teaches a suction adapter and medical draining set and method of using a tracheal draining device wherein the suction adapter is attached directly to the Tracheostomy tube and facilitates suctioning with a suction catheter which allows a opening to advance the catheter through this device to be introduced into the patent's lower airway and is now considered against the American Thoracic Society (ATS) recommendations. The above mentioned U.S. Pat. No. 4,510,933 does not eliminate the possibility of infection caused by deep suctioning or the trauma that is associated with it.
As set forth in U.S. Pat. No. 4,240,517 by Holever, a tracheal tube adapter is connected to the end of the Tracheostomy tube and is designed to facilitate deep suctioning which is against the ATS recommendation. The device does not eliminate any of the problems typically associated with deep suctioning.
The device taught in U.S. Pat. No. 5,664,564 by Palmer teaches an aspirating and ventilating device to allow deep suctioning through the use of a catheter that is stored inside of a sterile baggy and can be reused for up to twenty-four hours. Again, its intended purpose is for deep suctioning which is against the ATS recommendation. Although this patent has decreased the cost of deep suctioning by reducing the number of catheters that have to be used to maintain a patent's airway, it has not eliminated all the contra indications associated with deep suctioning. By maintaining a catheter inside the sterile bag, it has reduced the risk of infection associated with poor techniques by the care giver which allows infection to be introduced into the patients lungs. However, it does not eliminate the complications associated with tracheal damage caused by the pointed suction catheters that are utilized with these types of systems, or the damage that can be done from using excessive pressures.
This particular patient is U.S. Pat. No. 4,723,543 by Beran teaches an endotracheal tube connecting to the outside of the Tracheostomy tube and inside the patient Y adapter. Its only function is to measure pressure or gas sampling as a pneumatic that will measure the patient's respiratory flow rate.
U.S. Pat. No. 5,282,463 by Hammersley and U.S. Pat. No. 6,047,699 by Ryatt et al teach anti-disconnect device designed to secure the trach to the circuit.
U.S. Pat. No. 5,287,852 by Arkinstall teaches an apparatus and method for maintaining a tracheal stoma. This particular system is not designed to provide ventilation or secretion management.
This U.S. Pat. No. 5,964,217 by Christopher teaches a tube for insertion into the patient's nose or mouth in emergency situations; not for long term management of a patient's airway, like a Tracheostomy tube. These type of tubes are used for short periods of times of approximately two weeks or less, to provide a patent airway in emergency situations.
The Tracheostomy tube, (“trach”), must be suctioned several times per day. The purpose of Tracheostomy suctioning is to remove mucus from the trach or windpipe. The procedure is performed with sterile equipment. Before and after the procedure, the patient may receive oxygen to reduce the risk of hypoxemia. The suction is applied for no more than 10 to 15 seconds at a time and should be discontinued if the patient experiences respiratory distress. The catheter used for suctioning should be no larger than one-half the diameter of the Tracheostomy tube.
SUMMARY
The present invention provides for a new tracheostomy tube to be used with various types of trach apparatus for completing the suctioning procedure. The embodiments use the new tracheostomy tube that allows suctioning to be done using a non-invasive method. One embodiment is used in conjunction with a modified tracheostomy collar that incorporates the suctioning mechanism therein or modified swivel adapter that incorporates a suctioning mechanism. Whether or not the patient requires mechanical ventilation will determine when to use the tracheostomy collar verses the swivel adapter. The other alternative is to use the new tracheostomy tube in conjunction with the standard trach collars and swivel adapters that are on the market today.
Conventional Tracheostomy tube designs require that the Tracheostomy tube be inserted into the patient's throat by an invasive techinque using a pointed tip such as is currently available with a pointed tip suction cather. These conventional suction catheters feature a sharp, pointed tip at the far end. During insertion and removal, the sharp tip can cause discomfort. In addition, the respiratory mucosa can be injured, torn, or otherwise damaged due to the sharp tip and the procedure wherein the catheter is introduced or remove from the Tracheostomy tube. Reducing the trauma associated with the use of pointed tips and/or deep suctioning reduces the likelihood or the propensity for further medical complications. Moreover, conventional suctioning methods cause increased tracheal damage and infection, which often require tracheal surgery, particularly in the pediatric population.
The instant invention offers a non-invasive alternative to the standard products and procedures. The present invention features a swivel adapter with a built-in suction tubing connection for use on the ventilated patient. The modified component utilizes a standard fitting.
The instant product design complies with the American Thoracic Society's recommendation for suctioning using the “Measured
Carroll John B.
Klinberg Naum
Carrithers David W.
Carrithers Law Office PLLC
Lewis Aaron J.
Mitchell Teena
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