Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-05-14
2001-06-12
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S246000, C251S149100
Reexamination Certificate
active
06245048
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a medical valve, and in particular to a valve which, when connected between a first medical implement, such as a fluid source, and a second medical implement, such as a catheter, facilitates fluid flow therebetween, and when the first medical implement is disconnected therefrom, induces a positive flow of fluid through the valve in the direction of the second medical implement.
BACKGROUND OF THE INVENTION
The manipulation of fluids for parenteral administration in hospitals and medical settings routinely involves the use of connectors and valves for selectively facilitating the movement of fluids between two points. These valves are typically placed along a fluid flow line leading to a patient or other destination. For example, the tube may lead to a catheter having its tip positioned within a patient.
The valve is arranged so that a fluid source or other line may be connected thereto for providing a fluid flow from the source to the patient. When the fluid source or line is removed, the valve closes, sealing the line leading to the patient.
The element which is connected to the valve may comprise a tube or other medical implement such as a conduit, syringe, IV set (both peripheral and central lines), piggyback line, or similar component which is adapted for connection to the medical valve. Unfortunately, prior art valves suffer from a problem arising from the disconnection of these medical implements from the valve.
These valves define a space within them through which a fluid or other material may flow from the implement to the line on which the valve is mounted. When the medical implement is connected to the valve, it typically occupies a portion of this internal valve space, displacing the fluid (whether it be a liquid or air) within the valve.
A problem arises when the medical implement is disconnected from the valve. When the implement is disconnected, it no longer occupies a portion of the space in the valve. The increase in space within the valve results in the fluid in the valve and line to which the valve is connected moving to fill the space. In effect, the removal of the implement creates a suction force which draws fluid into the valve.
In the medical setting, this movement of fluid is very undesirable. When the valve is connected to a fluid line leading to a patient, the movement of fluid through the line towards the space in the valve has the effect of drawing blood from the patient in the direction of the valve. A serious problem may result in that this blood may clot and clog the catheter near its tip, rendering it inoperable, and may even result in a clot of blood in the patient, which may prove fatal.
One attempt at overcoming this clogging problem has been to coat the inner surface of the catheter near its tip in order to prevent blood from sticking to its interior surfaces. This method has generally been unsuccessful in preventing clogging of the catheter.
The risk of blood clogging of the catheter is significantly heightened where the inner diameter of the catheter is small (e.g., 27 gauge). These small catheters have the advantage, however, that they reduce the trauma and discomfort caused by insertion into a patient. Because these catheters have a very small passage therethrough, even a small suction force may draw sufficient amount of fluid back through a catheter toward the valve to introduce blood into the catheter tip, which blood may clog the catheter's passage.
Overcoming the above-stated problem is made more difficult when considering other criteria which the valve must satisfy. For example, the valve should be arranged to so that it does not have any fluid stagnation points. If the fluid is allowed to stagnate in one or more areas of the valve, bacteria growth and other problems may occur.
In addition, the valve should have an internal flow path which is smooth. Sharp edges and corners may damage blood cells and cause hemolysis.
A valve which overcomes the above-stated problems is desired.
SUMMARY OF THE INVENTION
In accordance with the present invention there is provided a valve which is advantageously utilized between two medical implements. The valve of this invention has several features, no single one of which is solely responsible for its desirable attributes.
Most importantly, the valve is arranged to provide a positive flow (i.e. the movement of fluid in the direction out of the valve as opposed to into the valve) when one of the medical implements is disconnected therefrom. At the same time, the valve is safe, reliable and capable of being used repeatedly, is simple to manufacture and use, and is suitable for high pressure applications.
The valve of the present invention is particularly suited to use in an application where one of the medical implements comprises a catheter having its tip positioned in a patient. In a preferred embodiment the second medical implement comprises a fluid source having a connector for connection to the valve.
The valve of the present invention has a fluid space which expands upon connection of the second medical implement and contracts upon disconnection of the medical implement. When the valve is connected to a catheter, disconnection of the second medical implement creates a positive flow from the valve to the catheter tip upon disconnection of the medical implement to avoid the potential problems of blood-clogging. The valve is particularly suited for applications with a catheter where it is desirable to avoid negative flow, but may be used for other applications as well.
Preferably, the valve includes a housing adapted for connection to a first medical implement and a second medical implement. The valve defines a fluid space therein, and includes means for increasing the fluid space when the second medical implement is connected, and for decreasing the fluid space when the second medical implement is disconnected. Means are also preferably provided for defining a fluid path through the valve when both medical implements are connected thereto, and for closing the fluid path when the second medical implement is disconnected.
Further objections, features and advantages of the present invention over the prior art will become apparent from the detailed description of the drawings which follows, when considered with the attached figures.
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Bui Dennis M.
Fangrow, Jr. Thomas F.
Schmidt Jonathan T.
Wait Daniel J.
ICU Medical Inc.
Knobbe Martens Olson & Bear LLP
Rodriguez Cris
Seidel Richard K.
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