Catheter assemblies with flexible radiopaque marker

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Reexamination Certificate

active

06520934

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to medical devices in general and catheter assemblies having flexible radiopaque markers in particular.
BACKGROUND
Catheters have found widespread clinical use, for both diagnostic and interventional procedures. In performing, for example, intravascular catheter procedures, a physician typically uses a fluoroscope (e.g., an X-ray machine) to visualize a patient's vascular structure. To assist the physician in guiding and positioning the catheter within the patient's vascular system, catheters typically have one or more marker bands affixed to the shaft that are highly visible under the fluoroscope.
FIGS. 1A and 1B
illustrate an example of a balloon catheter assembly and a marker band, respectively, from the prior art. The catheter assembly
10
comprises a shaft
15
and a balloon member
14
disposed around a distal section of the shaft
15
. The balloon member
14
has a proximal portion
11
and a distal portion
13
and an inflatable portion
12
therebetween. The proximal portion
11
and the distal portion
13
of the balloon member are affixed to the shaft
15
. The catheter assembly
10
depicted in
FIG. 1A
has a single marker band
19
positioned to indicate a midpoint of the inflatable portion
12
of the balloon member
14
.
The marker band
19
is shown in an expanded view in FIG.
1
B. The marker band
19
is a solid band of a radiopaque metal, such as gold, platinum, tungsten, iridium, etc. and alloys thereof. Typically, the marker band
19
is slipped around and onto the shaft
15
and then affixed to the shaft with an adhesive or by heating the shaft.
Vascular structures can be very tortuous, and marker bands of the prior art present an impediment to navigating the catheter through such tortuous anatomy, especially around a tight bend, because such marker bands are rigid and have no flexibility. The marker band's rigidity additionally present problems to passing the catheter through a lesion.
SUMMARY
The present invention provides catheter assemblies having at least one flexible radiopaque marker affixed with the shaft. In one embodiment of the present invention, the flexible radiopaque marker is a segmented band of a radiopaque material. The segmented band further has a longitudinal slit running from one end of the segmented band to the opposite end of the segmented band. In another embodiment, the flexible radiopaque marker comprises a coil of a radiopaque material. The radiopaque material may comprise a radiopaque metal. Alternatively, the radiopaque material may comprise a polymeric material loaded with a radiopaque agent.


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