Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-06-04
2001-08-21
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06277108
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a splittable introducer for insertion of a catheter, guide wire and other medical devices into a patient. More particularly, it pertains to a splittable introducer employed for indicating a position of a device located within a body.
BACKGROUND OF THE INVENTION
Introducer devices are employed for inserting catheters, guide wires, or other medical devices into patients. A typical procedure provides for insertion of a needle into the vasculature of a patient. After insertion of the needle, a guide wire is inserted through the needle, and the needle is removed. The dilator and the sheath are inserted over the guidewire, and the dilator may be removed leaving the sheath protruding from the patient's vein. A diagnostic or therapeutic catheter (e.g. a central venous access catheter) or guide wire or other medical device, is then inserted through the sheath into the patient.
The catheter or medical device which is inserted through the introducer, depending on the application, must be positioned precisely within the vasculature or tissue of the patient. However, once inserted, it is difficult to monitor the location of the introducer and/or the medical device inserted into the patient.
In addition, the catheter is coupled with other medical devices before the introducer is removed. It is therefore necessary to carefully remove the introducer without disturbing the catheter. To remove the introducer, the encasing sheath is then typically longitudinally sheared and removed from the catheter or guide wire and the patient such as by applying opposing force to opposed wings or tabs of the introducer device.
Accordingly, what is needed is an introducer, the location of which can be identified while inserted into a vasculature of a patient. What is further needed is an introducer which can be easily removed once inserted into a patient.
SUMMARY OF THE INVENTION
An introducer for use with a medical device is described where the introducer includes a severable elongate sheath adapted to be inserted into a circulatory system to a desired location in a vessel. The elongate sheath is severable such that it can be removed from medical devices inserted therethrough without disturbing or removing the medical device from the patient. The sheath extends from a proximal end to a distal end and includes an elongate passage. In addition, a radiopaque marker band is coupled with the severable sheath and, in one embodiment, is disposed proximate to the distal end of the elongate sheath, where the marker band is severable. In one embodiment, the distal end of the severable sheath is thermoformed around the severable marker band.
The severable marker band is formed, in one embodiment, from a thin structure of material in order to facilitate its severability. In one embodiment, the severable marker band has a thickness of 0.0015 inches. In another embodiment, the severable marker band has a thickness of 0.0025 inches. Alternatively, the severable marker band has a thickness between about 0.0005-0.005 inches.
In another embodiment, the severable marker band includes at least one aperture therein, or alternatively, the severable marker band includes a plurality of apertures therein. Alternatively, the severable marker band includes a perforated line to permit severability of the marker band. The severable marker band can extend between side edges of the marker band, or can be disposed between a top edge and a bottom edge of the marker band. In yet another embodiment, the severable marker band is formed of a braided material. Alternatively, the marker band is formed of a porous material, such as a mesh screen. The marker band is alternatively severable by forming a slot in the marker band.
In another embodiment, a system for use in fluoroscopy is provided. An introducer for use with a medical device includes a severable elongate sheath adapted to be inserted into a circulatory system to a desired location in a vessel. The elongate sheath is severable such that it can be removed from medical devices inserted therethrough without disturbing or removing the medical device from the patient. The sheath extends from a proximal end to a distal end and includes an elongate passage. In addition, a radiopaque marker band is coupled with the severable sheath and, in one embodiment, is disposed proximate to the distal end of the elongate sheath, where the marker band is severable. In addition, a means for severing the introducer is provided, which can include a slitter, a rip-cord, a weakened portion, or other means.
Advantageously, the introducer with marker band allows for improved visibility of the introducer under fluoroscopy, and permits a practitioner to identify the location of the introducer relative to the location of the intended implant device. The various configurations of the marker band allow for the introducer and the marker band to be splittable. In addition, the marker band remains securely attached to the introducer to prevent dislodgement therefrom during slitting of the introducer.
These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.
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Liebl David A.
McBroom Jeffrey A.
Kennedy Sharon
Medamicus, Inc.
Schwegman Lundberg Woessner & Kluth P.A.
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