Surgery – Means or method for facilitating removal of non therapeutic... – Urinary catheter
Reexamination Certificate
2000-02-23
2004-09-21
Calvert, John J. (Department: 3761)
Surgery
Means or method for facilitating removal of non therapeutic...
Urinary catheter
C604S328000
Reexamination Certificate
active
06793651
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to catheters and, in particular, to urinary catheters. More particularly, the present invention relates to a urinary catheter system with a urinary catheter connector.
2. Description of Related Art
The manipulation and movement of fluids is very important in various hospital and medical settings. The movement of fluids frequently requires various connectors and adapters for facilitating the movement of fluids between different points. For example, urinary drainage system is are known to provide a pathway for urine to flow from the body of a patient into a urine receptacle. These drainage systems frequently use indwelling urinary catheters or drainage tubes which are connected to a drainage device hub which, in turn, is connected to the urine receptacle. This system therefore provides a flow path for the urine from the patient to the urine receptacle.
Known urinary drainage systems typically connect one end of the indwelling urinary catheter to the drainage hub by a clamp or other known type of connector. The drainage hub is connected to the urine receptacle by a male type connector such as a male Luer Lock. As known, the urine receptacle may include a “bedside” collection bag, a leg collection bag or stoma bag.
In all instances of conventional urinary drainage systems, detachment of the urine receptacle from the drainage system requires the disconnection of the receptacle from the drainage hub, thus creating an opening in the system. This open drainage system provides a pathway through which bacteria and other infectious matter can travel through the drainage system and into the urinary system of the patient, which may result in severe urinary tract problems such as urinary tract infections. Thus, each time the urine receptacle is removed from a conventional urinary system, for example for replacement or cleaning, this increases the risk of infection for the patient.
Additionally, known urinary drainage systems frequently require irrigation of the indwelling urinary catheter to provide medication to the bladder or other parts of the patient's urinary system. Irrigation of the indwelling urinary catheter may also be required to remove debris such as blood clots from the catheter. The irrigation of the indwelling catheter, whether to provide medication or remove debris, also requires disconnection of the urine receptacle and opening of the system to allow a syringe or other medical instrument to be attached to the drainage hub. The syringe or medical instrument is then used to irrigate or provide medication to the patient, and then it is disconnected from the drainage hub and a urine receptacle is reattached. This repeated opening of the drainage system greatly increases the risk that bacteria and other infectious materials will travel into the urinary system of the patient and cause a urinary tract infection.
Additionally, known urinary drainage systems require that the urine receptacle be removed so that urine samples can be obtained and other testing or treatment may be performed. Thus, each time testing or treatment of the patient is required, which so may be frequent, the system must be opened and this further exposes the patient to the risk of infection and other maladies.
Further, it is known that the urine receptacle is often a source for bacteria and other infectious materials because it may act as an incubator in which various organisms grow. Accordingly, in order to decrease the possibility of an infection, patients using known urinary drainage systems and health care providers are cautioned never to have the collection bag at a height greater than the bladder of the patient because that may allow urine from the collection bag to flow into the urinary catheter or urinary system of the patient. Additionally, all patients and health care providers are informed never to move or shift the collection bag so that urine flows into the urinary catheter or urinary system of the patient. Finally, patients and health care providers must use extreme caution during the connection, disconnection and opening of the drainage system because of the risk that material from the urine receptacle will enter the urinary catheter or urinary system of the patient.
Moreover, current urinary drainage systems having an open hub permit the leakage of urine during disconnection of the urine receptacle. Contact with this body fluid by the health care provider may result in associated pathogen-caused diseases as is well known in the art. Thus, it is desirable to prevent contact of the body fluid and health care workers or patients. The present invention, as described below, advantageously eliminates the potential contact of a patient's bodily fluids and the health care provider and patient's skin.
SUMMARY OF THE INVENTION
A need therefore exists for a urinary catheter system which eliminates the above-described disadvantages and problems.
One aspect of the present invention is a urinary catheter system which includes a urinary catheter and a connector including a proximal end and a distal end. In particular, the system desirably includes an indwelling urinary catheter which is attached to the proximal end of the connector and the connector includes a bi-directional, resealable valve that allows fluid to flow in either direction when open. The system preferably includes a medical implement which is removably attached to the connector. The medical implement may include a collection appliance with a reservoir that may be filled with fluid. The collection appliance preferably includes a one-way valve so that once fluid enters the appliance, it cannot flow back through the system. This decreases the risk of infection to the patient and health care provider because the fluid is trapped in the appliance. Additionally, because the valve inside the connector is resealable, the collection appliance or other medical implement may be removed and fluid will not flow through the valve. Accordingly, the collection appliance or medical implement can be readily replaced, cleaned or removed to allow sampling, testing or treatment of the patient to occur without leaking or spilling of the fluid contained in the system.
Another aspect of the present invention is a urinary catheter system which facilitates fluid flow between the patient and the collection appliance while maintaining a sterile environment. Advantageously, because the connector can be easily swabbed with a suitable substance such as alcohol or disinfectant, the connector can be sterilized and reused. Thus, various medical implements can be connected and disconnected to the system and a sterile environment remains. Additionally, because the resealable valve closes the fluid pathway through the connector if a suitable medical implement is not attached to the connector, bacteria and other foreign matter cannot enter the urinary catheter or urinary system of the patient. Consequently, this closed system greatly reduces the risk of infection to the patient.
Yet another aspect of the invention is that the connector includes a proximal end which is adapted to be in fluid connection with a urinary catheter. In particular, the proximal end of the connector includes an elongated body with one or more outwardly extending annular flanges. The elongated body is sized and configured to be inserted into an end of the urinary catheter and the flanges are sized and configured for secure, fluid-tight connection of the catheter and connector. The annular flanges preferably have an angled first surface and an angled second surface to create a secure friction or interference fit between the catheter and the proximal end of the catheter.
Yet another aspect of the invention is that the connector includes a distal end which has an adaptor that enables the connector to be removably attached to medical implements such as a syringe or collection appliance. Preferably, the adaptor is a Luer Lock-type connector that provides a secure, fluid-tight connection that can be easily
Bennett Rita Latterman
Fangrow, Jr. Thomas F.
Foss Evelyn L.
Calvert John J.
ICU Medical Inc.
Kidwell Michele
Knobbe Martens Olson & Bear LLP
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