Surgery – Respiratory method or device – Inhaled gas heated or humidified by exhaled gas
Reexamination Certificate
2000-03-07
2003-02-11
Dawson, Glenn K. (Department: 3761)
Surgery
Respiratory method or device
Inhaled gas heated or humidified by exhaled gas
C128S207140, C128S203160
Reexamination Certificate
active
06516798
ABSTRACT:
TECHNICAL FIELD
The present invention pertains generally to tracheal surgery or tracheotomy, and in particular to an improved tracheal humidification system. The system of the present invention employs different breathing and secretion paths, and further elevates the breathing filter so that it cannot be contaminated by secretions.
BACKGROUND ART
After having a tracheotomy, a patient is fitted with a ventilator system to facilitate healing and recovery. One of the functions of the ventilator system is to trap bronchial secretions. Another feature of the ventilator system is to humidify the air that the patient breaths to reduce drying of the mucus. For years the ventilator systems injected aerosolized water which was directed at the trachea. While this time-tested method of providing humidification worked, it has inherent drawbacks that could not be overcome. Some of drawbacks are:
Current aerosols require high-flow oxygen and greatly increase the cost of caring for the patient.
Tubing must be constantly drained to provide free airflow. This is labor-intensive.
The environment is kept wet at the bedside by the constant bombardment of moisture.
The open nature of the tracheal aerosol leaves the patient susceptible to infection by airborne and contact sources.
The high particulate water content of the air being delivered to the patient is suspected as being partially responsible for the hyper-production of secretions in the patient with the tracheotomy.
For those facilities that do not have piped-in air, those patients who require humidification must be either placed on oxygen or noisy, hot compressors placed in their rooms.
Current aerosols are noisy, and high noise levels do not provide for a good environment of care.
The open nature of the aerosol delivery system also exposes the caregiver, physician and family to possible exposure as patients cough and secretions are expelled into the surrounding environment.
Contamination of the surrounding environment opens the possibility for nosocomial infections, especially for those patients in close proximity.
Secretions are expelled and tend to collect around the trachea, soiling linen, tracheal dressings etc., and increasing nursing time at the bedside and the overall cost of care.
About 10 years ago heat moisture exchangers (HMEs) and hydroscopic condensing humidifiers (HCHs) were developed as an alternative to conventional means of humidification. These systems have been used on mechanically ventilated patients with great success by using the patients' own humidity and moisture but have been used only rarely on naturally ventilated patients due to their tendency to clog with secretions (refer to FIG.
1
). The system
500
includes a ARC Thermoflo™ Medical HCH filter
502
and a flexible hose
504
which connects the filter
502
to the trachea of the patient. Flexible hose
504
comprises both the breathing path (airway)
506
and the secretion path
508
for bronchial secretions. The system
500
can also include a input port
510
for low flow oxygen. These systems
500
have reduced costs, decrease infection rates and provided many other savings for the medical facility. However, these systems
500
are troublesome in that the high volume of secretions associated with a tracheotomy clog the filter
502
thereby making breathing difficult. If the filter is not continuously monitored and regularly replaced, near-complete occlusion of the airway
506
could result.
DISCLOSURE OF INVENTION
The present invention is directed to an improved tracheal humidification system which overcomes the disadvantages of the prior art. A preferred name for the present invention is the “Safe and Silent” Waterless System. In the present invention the HCH or HME filter is removed from the path of secretions. That is, the breathing and secretion paths or passages are different. By removing the filter from the path of secretions, the filters now perform as designed, capturing humidity and warmth while staying free of secretions that increase resistance and make breathing difficult. The patient breathes through a closed system, exhaling through the HCH or HME filter, which captures the patient's own heat and humidity. The patient then inhales and the entrained air recaptures the moisture and heat. The present invention also provides minimal deadspace and maximal drain for expelled secretions.
The present invention also includes baffles which minimize the mixing of air between the breathing path or airway and the bilateral secretion drain tubes. This minimizes mixing of CO
2
trapped in the drain tubes. The secretion tubes have a unique suction end cap which provides for the clearance of expelled secretions, while maintaining the integrity of a closed system. The present invention also has a closed suction catheter which provides suctioning while completing the emphasis on a closed system.
The present invention has the following advantages over current methods of humidification:
1. The closed system means that the patient is breathing air that has been filtered and thus their exposure is reduced. The closed system consists of a plurality of tubular members connected by rotatable joints. In a preferred embodiment, the tubular members are fabricated from transparent plastic to that the inside of the system may be visually inspected.
2. Expelled secretions are captured in a drain tube and therefore the surrounding environment is not contaminated, reducing exposure to the staff, visitors, etc.
3. No accumulation of secretions on the patient means less time for care at the bedside, reduced linen usage, and better care of the environment.
4. The system of the present invention is passive and therefore completely silent. Current alternatives are noisy and cause the facility noise level to be exceptionally high.
5. The system employs low-flow O
2
. Oxygen costs can be greatly reduced.
6. By employing use of a closed suctioning system as well, costs for suctioning supplies can be greatly reduced.
7. The system is portable.
8. The system reduces waste disposal.
9. Finally, the closed system of the present invention provides for fewer infections. Patient receiving continuous, mechanically assisted ventilation have 6-21 times the risk of acquiring nosocomial pneumonia compared to patients not receiving ventilatory support.
In accordance with a preferred embodiment of the invention, a tracheal humidification system for placement upon the chest of a patient who is reclining on his/her back, includes (1) a filter for humidifying air being breathed by the patient, the filter is disposed in an uppermost portion of a breathing path, and (2) at least one secretion path for collecting secretions from the patient. The filter is disposed above the secretion path, so that the secretions are prevented from contacting and contaminating the filter.
In accordance with an important aspect of the invention, the breathing path is oriented in a substantially vertical position.
In accordance with an important feature of the invention, the breathing path has a flexible tracheal connecting portion for connecting to a patient.
In accordance with another important aspect of the invention, the upper portion and filter are rotatable about a substantially vertical plane with respect to the tracheal connecting portion.
In accordance with another important feature of the invention, the secretion path includes a drain tube for collecting the secretions of the patient.
In accordance with another important aspect of the invention, the secretion path has a baffle to restrict the flow and mixing of air between the breathing path and the drain tube.
In accordance with another important feature of the invention, the drain tube has an end portion having a selectively closable and openable secretion clearance cap.
In accordance with another important feature of the invention the tracheal humidification system is closed.
Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which
Dawson Glenn K.
Freilich Hornbaker & Rosen
Masters Ted
Tyson Timothy Thut
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