Fluid handling – Systems – Multiple inlet with single outlet
Reexamination Certificate
2001-03-02
2002-11-19
Hepperle, Stephen M. (Department: 3753)
Fluid handling
Systems
Multiple inlet with single outlet
C251S007000
Reexamination Certificate
active
06481462
ABSTRACT:
BACKGROUND OF THE INVENTION
1. The Field of the Invention
The present invention relates generally to devices used to implement various medical procedures. More particularly, embodiments of the present invention relate to an improved valve for use in flushing medical devices and for facilitating the performance of various diagnostic, analytic, therapeutic, and other procedures.
2. The Relevant Technology
In the medical field, tubes and catheters are used in a wide variety of applications including drainage procedures or applications. In these type of applications, the tubes or catheters are of the type which carry various bodily fluids, including but not limited to, abscess fluids, urinary fluids, and biliary fluids. One purpose of such tubes or catheters is to decompress, relieve, or drain a specific collection of fluid from a patient. The expressed fluid is amassed into a collection bag for evaluation or evacuation.
It is important that the interior passageway, or lumen, in drainage tubes and catheters remain unobstructed and that materials such as particulates and/or residues not be allowed to collect or build up on the surface of the lumen in the catheter or tube. The buildup of particulates and/or residues on the interior surface of the lumen in the tube or catheter may lead to uneven, reduced, or obstructed flow. Obstructed, limited, or even uneven fluid flow may extend the recovery time of a patient, resulting in the potential for further complications or infections. For example, an obstructed catheter could cause an infection in the patient that may result, in some cases, in the sickness or even death of the patient. These problems are exacerbated in situations where catheters or tubes which are kept in place for longer periods of time.
In order to avoid such problems, the tubes or catheters must be periodically flushed to ensure that there is not a build-up of particulates or residue in the lumen that could block or otherwise impede the flow of fluid out of the patient. In general, the flushing procedure typically involves attaching a source of flushing, or cleansing, fluid, such as a saline solution, and directing the cleansing fluid under low pressure through the tube or catheter to remove any buildup occurring in the lumen. The fluid is then allowed to flow out the tube or catheter into a drainage bag.
When it is desired to flush the tube or catheter, the drainage bag must be disconnected and the source of cleansing fluid, usually a syringe, is attached to the tube or catheter that is fluidly connected to the patient. Once the cleansing fluid has been directed into the tube or catheter, the syringe or other source of cleansing fluid, must be disconnected and the drainage bag reattached. This procedure is particularly unsatisfactory because of the time required to unscrew the drainage bag, attach the syringe, and then to unscrew the syringe and reattach the drainage bag. In addition, after the cleansing fluid has been directed into the tube or catheter that is attached to the patient, there is an enhanced risk of fluid leakage during the detachment and reattachment process. Such leakage can cause an unsanitary condition and may potentially expose medical personnel and the patient to contamination. Further, if any fluid is accidentally discharged during this process, the medical personnel must take the time to sanitize the patient, the bedding, and themselves.
Another device, commonly referred to as a stopcock, can be used to make the flushing procedure somewhat easier for medical personnel and to reduce the risk of contamination and spillage. The stopcock is attached to the tube or catheter that is in fluid communication with the patient, and thereby connects the tube or catheter to the drainage bag. Typically, the stopcock includes a valve that must be manually operated so that the flow of fluid is directed either into a drainage bag or to an outside port for periodic catheter maintenance or flushing. This allows the fluid source, such as a syringe, to be attached to the outside port when it is time to flush the tube or catheter. Once the syringe is attached, the stopcock is manually adjusted so as to stop the flow of fluid to the drainage bag. This operation allows the cleansing fluid to be directed into the tube or catheter. Once all the cleaning fluid is in the tube or catheter, the stopcock is manually adjusted back to its original position, wherein fluid is allowed to flow into the drainage bag.
While the stopcock represents somewhat of an improvement over the manual flushing procedure, there have been various problems with the stopcock. For example, stopcocks have failed from usage or have had certain limitations to their use. One of the problems with using a stopcock is that the nurse or attendant must manually adjust the stopcock to cease the flow of fluid in the drainage catheter, and then open the access port to enable the flushing fluid to be directed into the lumen of the tube or catheter. Once the cleansing fluid has been directed into the tube or the catheter, the stopcock must again be manually adjusted to redirect the fluid flow into the drainage bag. These extra steps are time consuming and cumbersome.
There is also a possibility that the manual adjustments that are required may confuse the medical personnel so that the fluid flow out of the patient is misdirected. In addition, if for some reason, the medical personnel fail to return the stopcock to the original position, so as to allow the fluid to flow to the drainage bag, fluid will flow out the access port and contaminate the patient as well as the surrounding area. In addition to creating a biohazard, such a situation could result in loss of fluids that are needed to monitor the health of the patient.
A further problem with existing stopcocks is that the diameter of the passageway formed through the stopcock is typically smaller the diameter of the lumen in the tube or catheter to which the stopcock is attached. As a result, the passageway of the stopcock impedes the fluid flow by creating a bottlenecking effect as the fluid tries to flow through the stopcock.
BRIEF SUMMARY OF EMBODIMENTS OF THE INVENTION
The present invention has been developed in response to the current state of the art, and in particular, in response to these, and other, problems and needs that have not been fully or adequately resolved by currently available valve apparatuses. Briefly summarized, embodiments of the present invention provide an improved valve apparatus which permits flushing of a drainage tube or catheter without necessitating the disconnection of the drainage tube or catheter from the patient or from the drainage bag, and which is suitable for use in conjunction with various medical instruments such as are typically employed to perform diagnostic, analytic, therapeutic, and other procedures.
Embodiments of the present invention are well suited for use in the context of the flushing of catheters, drainage tubes, and the like. However, it will be appreciated that embodiments of the present invention are suitable for use in any application or environment where it is desired to drain materials from a fluid source, aspirate material from a desired location, and/or introduce various materials to a desired location, in a simple and effective manner.
In one embodiment of the present invention, a valve apparatus is provided that includes a housing having proximal end, which includes a barb configured to mate with various standard catheters and drainage tubes, and a distal end. The housing further defines a passageway therethrough, and includes an access port defining a bore arranged for fluid communication with the passageway. A plunger, preferably comprising nylon or the like and having a bulb on the bottom and defining a flushing passage aligned with the bore, is slidingly disposed in the bore for reciprocal motion between an open and closed position, and at least partially resides within a sealing ring, having a plurality of wiper rings in contact with the plunger, also disposed in the bore. Both the plunger and
Fillmore David J.
Longson Matthew S.
Hepperle Stephen M.
NeoSci Medical, Inc.
Stringham John C.
Workman & Nydegger & Seeley
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