Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-07-22
2001-09-18
Yasko, Jr., John D. (Department: 3734)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S096010, C024S543000
Reexamination Certificate
active
06290691
ABSTRACT:
BACKGROUND OF THE INVENTION
I. Field of the Invention
The present invention relates generally to vascular catheter systems and particularly to catheter systems that employ inflatable balloon devices to accomplish mechanical dilitation of vascular stenoses, more particularly those occurring in coronary arteries. The invention itself involves a clip device for convenient temporary retention of a catheter shaft in coiled form during interim periods when one of possibly several catheters being used in a procedure is temporarily removed from a guidewire between uses during the procedure. The clip device is preferably a single piece and includes a hub.
II. Related Art
Percutaneous dilitation of coronary stenoses by balloon dilitation catheter devices has evolved into an acceptance or a standard approach to alleviating many types of arterial blockages, especially partial coronary blockages, as it has, over the years, been demonstrated to be an effective, relatively low-risk procedure. During such procedures, often several different types of dilitation catheters are employed sequentially utilizing the same guidewire and, in some cases, the catheters may be alternately used several times, being inserted through the vascular system over an already indwelling guidewire. The catheter shafts are typically quite long, i.e., from about 70 cm. to about 150 cm. Once removed from the guidewire, the entire catheter may be set aside and kept within the sterile field for reuse. The length of the catheter shaft makes this quite inconvenient and awkward. No convenient device has been available to retain the catheter shaft in the coiled configuration until the next use. Thus, there remains a need for a system, particularly one integral with the catheter device itself for the temporary storage of the catheter shaft between uses which is easily operable and does not in any way interfere with the designed use of the catheter system.
Accordingly, it is a primary object of the present invention to provide an retention system for retaining a vascular catheter shaft in a relatively compact coiled configuration between the uses thereof.
Another object of the present invention is to provide a retention system for a coiled catheter shaft which is an integral part of and does not otherwise interfere with the normal operation of the catheter.
Yet another object of the present invention is to provide an integral hub/clip retention system for a coiled catheter shaft that is inexpensive and easy to operate.
Other objects and advantages of the invention will become apparent to those skilled in the art upon familiarization with the specifications, drawings and claims contained in this application.
SUMMARY OF THE INVENTION
According to the present invention, there is provided a convenient, easy to operate combination hub and clip device for releasibly securing an associated catheter shaft in a coiled configuration between deployments thereof. According to the invention, a hollow clip device is mounted at the proximal end of the catheter shaft and is designed to connect the catheter shaft to any associated external devices such as combined guidewire and inflation fluid input manifolds, or the like. The clip is designed with a hollow interior which allows the manifold or other connected device to access the various catheter lumens as desired. The clip device may incorporate a hub which, in turn, may be provided with an integral leuer proximal fitting to engage the manifold or other such connectable device. Of course, any other desired fitting may be molded to the body of the clip, without limitation.
The clip device particularly includes a system for releasibly securing the catheter shaft in a coiled configuration of one or more loops. This includes the provision of an external recess for accommodating a plurality of loops of the catheter shaft in the coiled configuration and a hinged clasp lid for providing a reclosable snap-fit latch over the coiled shaft to retain the coiled catheter shaft in the recess. The hinge attaching the clasp lid to the body of the clip is a flexible but preferably integral part of the clip device.
The clip including the hinged clasp lid is preferably molded as a single-piece system with the hinge being a “living” hinge capable of easy flexure and capable of being flexed a plurality of times during which the clasp lid is repeatedly opened and closed. The clip and clasp lid may be molded from a single polymer material in a one-shot injection molding operation. It is further contemplated, however, that a plurality of materials could be used, including a material for the hinge and clip that is somewhat softer and more pliable than that utilized for the main body of an associated hub. It should be recognized further that any appropriate moldable plastic material can be used for the device that is capable of being formed with internal passages and retaining its shape during use. These include many acrylic and polycarbonate materials, styrenes, ABS and other materials. The hinge and clip may be made of the same or rather softer polyester materials such as polyesters including Hytrel (Dupont), nylons, and other polymer materials such as polyethylenes, polypropylenes and other compatible materials. If two different materials are used, the device can be made by a two-shot process whereby both materials are injected at different gates into the mold cavity. Other processes are also feasible, such as insert molding.
An aspect of the integral hub and clip system of the invention is the harmonious manner in which the device can be incorporated in the catheter system without affecting the catheter itself or the devices to be attached to the proximal end of the catheter. In addition, it utilizes an easily operable snap lid latch and the overall configuration is one which does not interfere with the normal use and operation of the catheter system or get in the way during its use in a procedure.
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Sci-Med Life Systems, Inc.
Westman, Champling & Kelly, P.A.
Yasko, Jr. John D.
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