Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-03-03
2001-10-09
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06299593
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a new and improved drainage device for the chest cavity following lung surgery, and which will remove air, fluid, blood and blood clots from the chest cavity. Drainage tubes for open heart surgery typically use a single lumen drainage tube with large perforations connected to a vacuum source. These drainage tubes are used in patients after lung surgery, as well.
However, different post operative conditions prevail following heart and lung surgery. For example in the case of heart surgery, an accurate measure of bleeding and effective drainage of blood and blood clots to prevent compression on the heart (tamponade) is one of the most important features of a chest drainage tube. Also, in the case of heart surgery, venting or leaking air from the lung dues not represent a critical factor in the design of a chest tube.
By contrast in the case of lung surgery, an air leak from the chest cavity is always a major problem, particularly for lung volume reduction surgery of emphysematous lungs. Also, the measurement of blood loss following lung resection is generally not as critical compared to open heart surgery, since the amount of blood loss is small.
Another problem following lung surgery is that drainage tubes commonly used in both lung and heart surgery employ a few large round or elliptically-shaped holes (5-10 mm diameter), and these large hole sizes are required to remove blood and/or clots. These holes may become blocked when a suction pressure such as 15 torr is applied to the drainage tube causing the lung or other soft tissue inside the chest cavity to be sucked against the device.
Despite these major differences, the same chest drainage tube is used for both open heart and lung resection surgeries because the number of open heart surgeries far exceeds those of lung surgeries; hence, no chest drainage tube is presently available which is specifically geared for use following lung surgery.
Another problem associated with the use of chest drainage tubes is that following heart and lung surgery, air in the chest cavity tends to rise and blood/fluids tend to descend, and hence two chest tubes are routinely placed at high and low points in the chest cavity. However, if an air leak from the lung persists for more than a few days, the lung becomes adhered to the chest wall, creating isolated spaces around the lung. The development of these loculated air spaces which do not communicate with installed chest tubes is not uncommon. To circumvent this problem, some surgeons place three chest tubes through the chest wall using three separate small incisions. But, since each chest tube insertion site represents a potential source of wound infection, three skin incisions pose a three fold greater risk of a wound infection. Hence, it would be desirable to reduce the number of skin incisions and a corresponding reduction in the risk of infection.
A three-in-one, (or other multiple) drainage device embodiment of this invention would represent a considerable improvement over conventional multiple chest tube insertions. A three-in-one drainage device, for example, would reduce the possibility of infection at multiple insertion sites since only a single incision at the insertion site would be involved. There would also be reduced the amount of dressing gauze and adhesive tape which can cause skin irritation.
Various types of suction catheters, drainage catheters and filters are disclosed in U.S. Pat. Nos. 2,112,666; 3,308,825; 3,520,300; 3,623,483; 3,785,380; 3,810,471; 3,903,895; 4,068,664; 4,256,102; 4,398,910; 4,493,707; 4,601,697; 4,619,643; 4,692,153; 4,767,404; 5,045,075; 5,348,788; 5,370,610; and, 5,578,006. However, these patents do not disclose an effective means for removing air, blood and/or blood clots from a chest cavity surgical site with reduced problems due to aspiration or ingestion of lung or other tissue against or into the drainage device itself.
THE INVENTION
According to the invention, a drainage device for a chest cavity comprises a double lumen catheter constructed with an inner tube defining relatively few large perforations (e.g., elliptically shaped) and an outer tube with numerous, smaller perforations for primarily venting air and liquid such as bloody pleural effusion at a relatively high suction pressure. The inner and outer tubes are separated by septa, which prevent collapse of the outer tube. When suction is applied to the inner tube, a high negative pressure (e.g., 15-25 torr) at each perforation is transmitted to the space between the outer and inner tubes where the negative pressure is reduced, equalized and evenly distributed. Since the total surface area of the small perforations of the outer tube can be sized to be considerably greater than that of the few large perforations of the inner tube, the pressure at each small perforation of the outer tube can be considerably reduced.
Hence, the combination of significantly lower suction pressure per square centimeter and substantially greater number of perforations of the outer tube will reduce the possibility that lung or other soft tissue inside the chest cavity will be sucked against the chest tube. Consequently, there will be a reduced possibility that the small, venting perforations of the outer tube will become blocked.
In a further embodiment of the invention, two or more individual drainage devices may be combined into a single device, each individual drainage device being separated by a tear strip. Following insertion of the combined drainage device into a single insertion site, the individual drainage devices are separated and then moved to different locations in the chest cavity, thereby reducing problems associated with a plurality of insertion sites.
REFERENCES:
patent: 4182343 (1980-01-01), Inaba
patent: 4555242 (1985-11-01), Saudagar
Krawitz Willie
Mendez Manuel
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