Surgery – Means and methods for collecting body fluids or waste material – Aspiration collection container or trap
Reexamination Certificate
1998-11-19
2001-02-06
Weiss, John G. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Aspiration collection container or trap
Reexamination Certificate
active
06183453
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to an apparatus and method for covering a connector, and particularly to an apparatus and method for disconnecting and encapsulating a connector in a fluid collection system. More specifically, the present invention relates to a blood evacuation container having a nest that houses a cover for safely encapsulating a blood spike using only a one handed procedure.
2. Prior Art
Blood evacuation apparatuses are commonly used in autotransfusion systems for the purpose of collecting and reinfusing autologous blood to a patient. Autotransfusion refers to the reinfusion of a patient's own blood, known as autologous blood. Autotransfusion is the preferred method of transfusion since the blood being reinfused is the patient's own, therefore eliminating problems over blood type incompatibility and blood carrying diseases such as hepatitis and AIDS, etc. Moreover, autologous blood is more fresh than stored blood supplied by a donor and also contains the patient's own antibodies.
One type of autotransfusion, referred to as “post-operative” autotransfusion, is the transfusion of the patient's own shed blood following surgery where drained blood is collected and reinfused into the patient. Post-operative autotransfusion is limited in use since there are strict guidelines for the kind of blood which can be reinfused. Currently, the only post-operative blood believed suitable for autotransfusion is mediastinal blood, i.e. the blood which comes from the anatomical space or cavity in the chest.
Presently, chest drainage units are commonly used in the post-operative care of patients having surgery involving the chest cavity. Chest drainage units remove fluids and air from the inside of the chest cavity using tubing connected to the patient's chest cavity which drains the fluid and air into a collection chamber of the chest drainage unit. The chest drainage unit is attached to a source of vacuum which applies suction to the tubing and draws the trapped fluid and air from the chest cavity into the collection chamber. Once collected, the blood may be evacuated from the collection chamber using an autotransfusion pump or blood evacuation bag.
The use of blood evacuation systems, and particularly blood evacuation bags, in autotransfusion is well known. For example, U.S. Pat. No. 5,201,703 to Gentelia et al. discloses an apparatus for collecting blood from a chest drainage unit and reinftision of the blood back to the patient and is incorporated herein by reference in its entirety. The '703 apparatus uses a rigid outer container that is permanently attached to a flexible inner bag in fluid flow communication with the collection chamber of a chest drainage unit. Such types of apparatuses normally employ a needle or blood spike attached to the distal end of tubing connected to the blood evacuation bag. To establish fluid flow communication between the chest drainage unit and the blood evacuation bag, a user inserts the blood spike into a spike port or self-sealing diaphragm attached to the chest drainage unit. A source of vacuum is then applied to the outer container which generates a negative pressure in the interstitial space between the container and the bag. The negative pressure inside the container draws the blood from the collection chamber and into the bag through the infusion tubing linked therebetween. Once the bag is filled with blood the entire apparatus, including the outer container and inner bag, are disconnected from the chest drainage unit and suspended from a suitable suspension means in the vicinity of a patient to reinfuse collected blood.
However, one disadvantage of the above noted blood evacuation system is that the contaminated blood spike used to establish fluid flow must be safely encapsulated after use. To prevent the transmission of disease, the Occupational Safety and Health Administration (OSHA) has issued a regulation under 29 CFR § 1920.1030 that requires blood-tainted sharp items, such as blood spikes and the like, to be encapsulated by a one-handed capping procedure by the user. The needle used in the '703 apparatus and other similar apparatuses in the art employs a twohanded procedure when encapsulating the needle after detachment from the chest drainage unit. Specifically, the user must encapsulate the needle of the '703 apparatus by holding a needle cover with one hand and the blood-tainted needle in the other hand while inserting the cover over the needle.
Accordingly, there exists a need in the art for a blood evacuation system and related method that employs a one-handed procedure for safely encapsulating a connector, such as a blood spike or needle.
OBJECTS AND SUMMARY OF THE INVENTION
A principle object of the present invention is to provide an efficient and safe means of encapsulating a connector.
Another object of the present invention to provide a one-handed procedure for encapsulating a connector.
A further object of the present invention is to provide an apparatus that includes a nesting area for storing a needle cover used to encapsulate a connector.
Another object of the present invention is to provide a secure snap fit between the connector and the cover.
These and other objects of the present invention are realized in a presently preferred embodiment thereof, described by way of example and not by way of limitation, which provides for an apparatus and method for a one-handed procedure that encapsulates the connector of a blood evacuation system prior to reinfusion. The blood evacuation system comprises a separable, flexible inner bag inside an outer rigid container for reinfusing shed blood drawn from the collection chamber of a chest drainage unit. The outer rigid container includes a suction port connected to a source of vacuum for applying a negative pressure within the interstitial space between the rigid container and the inner flexible bag which causes blood to be drawn into the bag. Once the bag is filled to a desired level, the bag is removed from the container and suspended using a suitable suspension means within the vicinity of a patient for reinfusion. The container further includes a lid with a nest formed on the outside surface of the lid for employing a one-handed procedure for encapsulating a blood spike. The nest stores a blood spike cover used to encapsulate the blood spike after use. The one-handed procedure comprises the steps of disengaging the blood spike from a spike port of an autotransfusion system and inserting the blood spike into a cover disposed inside the nest of the container lid. Once inserted inside the nest, the cover encapsulates the blood spike and snaps closed, and the user may safely remove the covered blood spike from the nest without fear of contamination.
REFERENCES:
patent: 4522623 (1985-06-01), Laüterjüng
patent: 4957492 (1990-09-01), McVay
patent: 5356406 (1994-10-01), Schraga
patent: 5372593 (1994-12-01), Boehringer et al.
patent: 5549585 (1996-08-01), Maher et al.
patent: 5876387 (1999-03-01), Killian et al.
patent: 5944703 (1999-08-01), Dixon et al.
Brown, Rudnick, Freed & Gesmer, P.C.
Cho David J.
Leonardo Mark S.
Sherwood Services AG
Weiss John G.
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