1. Field of the Invention
This invention relates generally to packages for catheters and more specifically to elongate packages which maintain the catheter in a straight, non-spiral configuration.
2. Discussion of the Prior Art
A catheter is a device which is typically inserted through the skin of a patient and introduced into a body cavity, such as the heart, or a body passage such as a blood vessel. In these locations the catheter can be used to introduce or withdraw fluids, measure pressures, provide for visualization, and perform other mechanical and electrical functions. A catheter typically consists of an elongate cannula and a hub which facilitates attachment of the cannula to various external apparatus such as monitors.
Catheters are usually packaged in sterile containers which differ primarily in the configuration of the catheter within the package. Some packages maintain the catheter in a spiral configuration while other packages maintain the catheter in a straight, elongate configuration.
The elongate catheter packages consist generally of a long tube which receives the cannula of the catheter and an access device which receives the hub of the catheter. The access device typically includes a housing and a cap which is removable to provide access to the catheter in the tube. It is the interrelationship of the cap and the housing of the access device which is of particular interest to this invention.
In the past, caps have been slidably mounted on the housings and held in place by heat-shrink tubing which extends over the intersection of the cap and the housing. This tubing has been provided with an axial tear-strip which is removable to permit the cap to be withdrawn axially from the housing. In the absence of any seal between the cap and housing, a tight fit between the cap and the housing has been relied upon to help maintain the sterility of the packaged catheter. This requirement for a tight fit has made it very difficult to remove the cap so that it has often been necessary to grasp each of the cap and the housing with the entire hand in order to accommodate the required forces for removal.
Sterility has been a problem for several reasons. With the packages of the past, once the tear-strip was removed, if the catheter was not used, it nevertheless had to be discarded because it could not be resterilized. Furthermore, the indelicate grasping of the housing and cap often meant that non-sterile hands compromised sterile regions of the package and, more importantly, the sterile catheter.
Catheter packages are typically opened by a nurse who is not part of the sterile environment. While it is the job of that nurse to open the catheter package, only someone in the sterile environment should touch the catheter. This has presented a problem with respect to catheter packages of the past wherein the catheter hub has been deeply seated in the housing. In order for the catheter to be removed from the housing sufficiently that someone in the sterile environment can grasp and remove the catheter from the package, the nurse opening the package has typically attempted to shake the catheter package downwardly until the hub of the catheter clears the housing. Since the hub accounts for a large percentage of the weight of the catheter, the shaking of the package must be done carefully to prevent the entire catheter from falling on the floor.
Certainly the opening of a catheter package is not the most important procedure occurring in an operating room. Structures which have required rough and indelicate procedures to provide access to a sterile catheter simply cannot be tolerated in this stressful environment.
USPTO Backgrounds
USPTO Backgrounds