Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...
Reexamination Certificate
2000-10-20
2004-10-19
Bennett, Henry (Department: 3761)
Surgery
Respiratory method or device
Respiratory gas supply means enters mouth or tracheotomy...
C128S207140, C128S910000, C128S912000
Reexamination Certificate
active
06805125
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a respiratory suction catheter system with an improved mechanism for cleaning the tip of the catheter without drawing an excessive amount of air from the respiration circuit to which the endotracheal catheter is attached. More specifically, the present invention relates principally to a closed suction endotracheal catheter system which provides improved cleaning of the catheter while minimizing or eliminating air drawn from the patient's ventilation circuit.
STATE OF THE ART
There are a variety of different circumstances under which a person may be required to have an artificial airway, such as an endotracheal tube, placed in his or her respiratory system. In some circumstances, such as surgery, the artificial airway's function is primarily to keep the patient's airway open so that adequate lung ventilation can be maintained during the procedure. In many other situations, however, the endotracheal tube will be left in the patient for a prolonged period of time. For example, with many patients, the endotracheal tube will remain in place to sustain mechanical ventilation for the life of the patient.
If an endotracheal tube is to be left in place for any substantial amount of time, it is critical that respiratory secretions be periodically removed. This is most often accomplished with the use of a respiratory suction catheter which is advanced into the endotracheal tube. As the suction catheter is withdrawn, a negative pressure is applied to the interior of the catheter to draw mucus and other secretions from the patient's respiratory system. While a substantial amount of the mucus and other secretions will be withdrawn through the catheter lumen, a portion of the mucus and other secretions remain on the outside of the catheter.
Because patient secretions can contain infectious agents, such as streptococcus, pseudomonus, staphylococcus and even HIV, it is important to shield clinicians from contact with the catheter. Likewise, it is important to shield patients' from communicable pathogens in the environment and those which may be carried by the clinician. This is particularly important because patients on mechanical ventilation often have compromised immune systems.
In addition to concerns of cross-contamination, suctioning a patients' artificial airway potentially interferes with proper respiration. The most common group of patients who have indwelling endotracheal tubes for prolonged periods are those who must be mechanically ventilated. Mechanically ventilated patients will typically have a fitting or manifold attached to the proximal end of the endotracheal tube (i.e., the end extending outside the patient) at an endotracheal tube hub. A pair of ventilator tubes extend from a mechanical ventilator and are typically attached to the manifold by an adapter. One tube provides inspiratory air to the patient for inhalation. The other tube allows for exhaled or expiratory air to exit the system.
Until the 1980s, it was common to disconnect the patient from the manifold and ventilator tubes each time the patient needed to be suctioned. Interference with the air supply to the patient, even if only for a few seconds, was often unnecessarily distressing to the patient. These problems were initially overcome in the invention disclosed in U.S. Pat. No. 3,991,762 to Radford. Radford developed what is commonly referred to as a closed suction catheter system. In a closed suction catheter system, a catheter is maintained within a protective sleeve which is attached to the manifold. When suctioning is desired, the catheter is advanced through the manifold and into the artificial airway. Negative pressure is then applied to the catheter and secretions within the patient's respiratory system are evacuated. Improvements were made to the system by the invention disclosed in U.S. Pat. No. 4,569,344 to Palmer. Palmer improved the system by reducing the risk of cross-contamination between the patient and the medical personnel using the device. Since that time, there has been a significant shift toward the use of closed suction catheter systems.
The advantage of closed suction catheters is that the ventilating circuit is not detached from the patient during suction procedures, as it is during open suction procedures. Because the catheter is reused a number of times over a twenty-four hour period, it is important that mucus and other secretions be cleaned from the catheter prior to periods of non-use. If the secretions are not removed, the risk of auto-contamination increases. It is also important to clean the lumen of the catheter to maintain suction efficiency.
There are several mechanisms by which the catheter may be cleaned. First, in U.S. Pat. No. 4,569,344, there is shown a lavage port which enables the user to inject liquid into the area surrounding the distal end of the catheter after it has been withdrawn from the patient. When liquid is injected into the closed suction catheter apparatus and suction is applied, the liquid helps to loosen and remove the secretions from the exterior of the catheter.
One significant problem with simply injecting liquid and applying suction to remove it, is that the suction also causes a volume of respiratory air to be removed through the catheter. In a “closed system”, the air that is evacuated potentially disrupts the carefully controlled ventilatory cycles. Thus, the amount of respiratory air available to the patient is potentially decreased as a result of catheter cleaning. If the clinician has a hard time cleaning secretions from the catheter, suction may be applied through the catheter several times—thereby repeatedly drawing air from the ventilatory circuit.
Other closed suction catheters have been developed to have a cleaning or lavage chamber which is physically isolated from the ventilation circuit. For example, in U.S. Pat. No. 5,487,381 to Jinotti, there is shown a closed suction catheter which has a lavage chamber configured to receive the distal tip of the catheter as it is withdrawn from the manifold. A wall is then slid from an open position to a closed position to isolate the distal end of the catheter from the manifold and the ventilation circuit. A port is commonly provided to inject lavage solution into the cleaning chamber.
One problem which is present in such a configuration is that there is a lack of air flow to allow the suction catheter to clean properly. The application of negative pressure in the catheter can create a vacuum within the chamber in the absence of sufficient air flow into the chamber. Thus, isolating the chamber inhibits free evacuation of the cleaning solution. Additionally, movement of the wall requires an extra step on the part of the clinician.
Further, in one presently available product, the cleaning liquid commonly remains in the catheter due to the lack of airflow. Thus, contaminated liquids remaining in the catheter lumen can be reintroduced to the patient when the cleaning chamber is opened.
In addition to the above concerns, the closed suction catheters presently available suffer from the inability to clean the catheter tip to the most desirable extent. If pathogens or other contaminants remain on the catheter for too long, they can auto-contaminate the patient. Additionally if mucus and other secretions dry on the catheter, they can interfere with the suction efficiency, present an unsightly appearance and necessitate premature replacement of the closed suction catheter apparatus. Thus, there is a need for a catheter apparatus which has a mechanism for more effectively cleaning the distal end of the catheter without creating a substantial draw on respiratory air in the ventilation circuit.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an improved respiratory suction catheter apparatus which minimizes the amount of air drawn from the ventilation circuit during cleaning of the distal end of the catheter.
It is another object of the present invention to provide such a respiratory suction cathe
Crump Chet M.
Madsen Edward B.
Smith V. Roland
Ballard Medical Products
Bennett Henry
Dority & Manning P.A.
Weiss Joseph F.
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