Surgery – Diagnostic testing – Flexible catheter guide
Reexamination Certificate
2000-10-26
2003-05-27
Walberg, Teresa (Department: 3742)
Surgery
Diagnostic testing
Flexible catheter guide
C206S600000
Reexamination Certificate
active
06569106
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to containers for holding and dispensing medical guide wires. More particularly, the present invention relates to a modular containment device including a wire containment well and wiring dispensing/insertion port.
2. Description of the Prior Art
Guide wires are used for a wide array of medical procedures, or “interventional” cases. Such wire-guided procedures include, but are not limited to, angiography, cardiac procedures, non-vascular interventional procedures (ERCP), cystoscopic procedures, etc. The guide wires are traditionally supplied in sterile packages in thin plastic spiral housings. Once a package is opened, the housing is flushed with a sterilizing solution to wet the wire. The wire is used to position a medical device, such as a catheter, in a patient. After the wire is used in a particular procedure, it is removed from the catheter or device (and, thus, the patient) and wiped off manually. Next, it is either coiled up and placed into a saline-filled bowl, placed under a towel, or simply left in the medical procedure field, i.e., on the patient, on a surgical tray, etc.
It can readily be seen that for most medical procedures, particularly those common ones where multiple guide wires are required, it is not unusual for guide wires to become lost, contaminated, dropped, or difficult to sort, find, or obtain. In fact, it is common during a busy case that upwards of 5-6 wires may be used. Conventional wire retention bowls, with or without internal rims, are often loaded with all the coiled wires of a procedure. They often become tangled or impossible to differentiate among for specific uses during the procedure. That is, there may be several different types of wires in play, and those wires may differ by tip shape or stiffness, or by thickness differences that may not be apparent to the naked eye. It can be difficult to rapidly untangle or find them when needed. This can lead to delay, danger to the patient, or loss of access. Lost or contaminated wires add to increased costs. For example, one commercially available guide wire, sold under the name GlideWire™ can cost $40 or more for a single wire. Given the thousands of procedures requiring many wires, the cost associated with lost or unusable wires can be significant. Further, they add to procedure clutter, often being laid on top of a medical table and thereby limiting access to other items on the table (catheters, other guide wires, surgical blades, syringes, etc.) As a result, the risk of injury resulting from unintended contact with needles or blades underneath the jumbled wires is greatly increased.
Therefore, what is needed is a device or system for maintaining medical guide wires in an organized manner. Further, what is needed is such an organizing device or system that reduces the time required to clean the wires for re-use during a procedure. Given the number of procedures involving the use of one or more guide wires, the device or system should preferably be relatively inexpensive and easy to use.
SUMMARY OF THE INVENTION
In view of the foregoing, it is an object of the present invention to provide a device or system for maintaining medical guide wires in an organized manner. Further, it is an object of the present invention to provide such an organizing device or system that reduces the time required to clean the wires for re-use during a procedure. It is also an object of the present invention to provide such a device or system that is relatively inexpensive and that is easy to use. These and other objects are achieved with the present invention, which is a guide wire container that provides rapid and secure access to one or more guide wires.
The container may be formed as a single housing or a plurality of housing that may be detachably coupled together. Each housing is capable of holding one or more guide wires. Each housing may have a single wire holding compartment or a plurality of isolated chambers, with each isolation chamber designed to retain one wire or more as desired. Each housing may include engagement means including, but not limited to, hook-and-loop connectors, tongue-in-groove interfaces, clasps, so that multiple housings may be removably linked to one another. The number of housings and the number of isolation chambers, if any, forming the container is dependent upon the total number of individual guide wires desired for a particular procedure. That is, the unit or container may alternatively be designed to fit together in a modular fashion like cassette or CD racks. In that way, if the procedure unexpectedly requires additional wires, modular units may readily be added to the original set.
The container includes one or more top surface sealing elements, such as Luer Lok™ (shown) or catheter tips, for example. For the embodiment of the container where isolation chambers are employed, each such chamber preferably has its own sealing element. The sealing element is a removable closure device designed to seal container fill ports. When opened, a container fill port may be used to fill or prime the container with an appropriate fluid such as heparinized saline.
Individual wires, when removed from their original packaging, are inserted into the container through a wire access port on a front surface of the container. The wire access port includes a port hole sized to enable movement of the wire into and out of the port, a sealing membrane to minimize entry into the container of any fluids, contaminants, etc., that may be located on the wire, and a funnel port to facilitate directing the wire back into the container. The alternative isolation chambers may be guide devices that ensure the wire spirals into a narrowed area to avoid entanglement with adjacent wires.
In order to insert a wire into the container of the present invention, it is pushed back-end first against the membrane. The membrane may be fabricated of latex, silicon, or other suitable material. A wiping sponge positioned behind the membrane in the entryway of the container, is preferably saturated with water or suitable cleaning solution. This automatically wipes blood off the wire, eliminating the requirement to employ a healthcare provider to perform that function. In the process, the wire is pushed all the way in until a small amount, such as about 1-2 cm, remains external to the membrane. This makes the shape of the particular guide wire visible at a glance.
Using the container system of the present invention, individual medical guide wires may be held in place in a suitably coiled arrangement for easy removal and re-use, isolated from other wires, and bathed in heparinized saline. When a particular wire is needed, it is simply pulled out through the sponge, again wiping off any clot/debris and providing the user with a clean, ready-to-use wire without having to struggle to find it, to remove it from the housing, or to remove it from a bowl. The individual wire access ports may be sized as required to secure wires of the array of dimensions used in medical procedures, including those in the 0.014-0.038 cm diameter range. Sterile stickers with wire gauge, tip shape, and hydrophilicity information indicated may be applied to the container adjacent to the individual wire ports. These identification stickers could be used to speed identification of the wires during the procedure. The container, or one or more of a set of individual containers coupled together, may include a weighted base or other suitable means to ensure that it will remain fixed in a desired position and only moved intentionally.
The present guide wire containment device may be employed on every medical procedure tray. It may be fabricated of inexpensive materials, has no moving parts, and is simple to use. It is modular and disposable. It automatically cleans the wire each time it is used. It fits in far less space than a sterile bowl or random pile of coiled wires, towels, or housings. It can be made in a variety of sizes to accommodate different space restrictions and/or spec
Atwood Pierce
Fastovsky Leonid M.
Walberg Teresa
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