Surgery – Diagnostic testing – Flexible catheter guide
Reexamination Certificate
1998-10-27
2002-04-30
Shaver, Kevin (Department: 3736)
Surgery
Diagnostic testing
Flexible catheter guide
Reexamination Certificate
active
06379319
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to devices and methods for manipulating and directing guidewires and other “rails,” e.g. catheters, within the human vasculature, over or through which other devices are then introduced into the vasculature to perform a medical procedure.
BACKGROUND
In the field of vascular intervention, and more specifically in the field of interventional cardiology, devices known as guidewires are often used to facilitate access to a patient's vascular system, placement of various devices and/or performance of certain procedures. A guidewire is maneuvered into place to act as a guide for positioning the placement of subsequent devices “over the wire.” The guidewire, typically ranging from 0.010″ to 0.038″ inch diameter, as compared to an interventional catheter which may range from 0.040″ to 0.25″ inch diameter, is extremely flexible and tracks easily into a patient's vessels, allowing the physician to obtain an initial position, and many times to find the optimal position, in the vasculature prior to tracking a larger interventional catheter over the wire to perform an intervention. In addition, a guidewire may maintain access to a certain site in the vasculature should it be necessary for the physician to use multiple devices to perform an intervention at the site, or to perform multiple interventions at different sites in the vasculature.
Due to their flexibility, guidewire access minimizes trauma to the vessel being treated and assists in directing or guiding other devices through the curvature and tortuosity of the vascular system. Unwanted trauma may include “skiving” of the vessel, wherein a less flexible device may scrape the vessel wall at an undesired angle, and unintended perforation, wherein a device may be pushed through the vessel wall in an uncontrolled manner, leading to excessive bleeding (tamponade) and/or other severe patient complications.
Guidewires act as a rail over which other less flexible and larger diameter devices may be delivered safely, thereby reducing the risk of unwanted vessel trauma In current medical practice, guidewire access and performance of procedures “over the wire” are the preferred mode of vascular device delivery. As such, it is critical to the clinical acceptance of new devices and therapies for them to be compatible with this technique, and to be delivered over the wire.
In light of the development of certain clinical procedures, there is a need for devices and methods that more specifically direct, place and maintain a guidewire or other rail at one or more selected locations in the vasculature.
SUMMARY OF THE INVENTION
The present invention is directed to various devices and methods for achieving directed placement of guidewires or other flexible rails over which other catheters or other devices may be introduced to a targeted location. For example, the devices and methods of the present invention may be incorporated into novel clinical procedures, such as those disclosed in U.S. patent application Ser. Nos. 08/730,327, filed Oct. 11, 1996, 08/730,496, filed Oct. 11, 1996, and 08/970,694, filed Nov. 14, 1997, the disclosures of which are expressly incorporated herein by reference.
Several of these procedures are performed in an “extravascular” location (e.g., from vessel to vessel, from vessel to another structure, or from vessel to another location or space within the body), necessitating the positioning of guidewires outside the normal “intraluminal” location within the vessel itself. It may also be necessary to “orient” the entrance and exit of guidewires between vessels to better control the angle of placement of subsequently placed devices.
Further, in the case where multiple devices are tracked over the wire subsequent to initial placement, it may be necessary to stabilize the wire within the vessel or other location to minimize potential vessel trauma due to multiple manipulations of subsequently placed devices. Also it may be necessary to minimize potential loss of placement of the guidewire should it become displaced in response to forces exerted on it by catheters as they are advanced or removed from the vessel.
In one aspect of the present invention, devices are provided for directing a guidewire, catheter or other rail substantially laterally with respect to a body passage within which the device is introduced. In a first preferred embodiment, the device includes an elongate member having proximal and distal ends, having a distal portion adapted for insertion within a body passage, and defining a longitudinal axis and an outer peripheral surface. A lumen extends between the proximal end and a peripheral opening in the distal portion, and a deflecting member is provided therein adjacent to the peripheral opening for directing a guidewire device substantially laterally with respect to the longitudinal axis.
Preferably, the deflecting member has a predetermined acute deflection angle for directing the guidewire device substantially distally and laterally. Alternatively, the deflecting member may have a predetermined oblique deflection angle for directing the guidewire device substantially proximally and laterally. In a preferred form, the guidewire device is a needle assembly having a guidewire lumen extending therethrough, although alternatively, the guidewire device may simply be a guidewire alone, which may be deflected substantially laterally when it contacts the deflection member and is advanced through the peripheral opening. In addition, the device may include an imaging and/or orientation element on the distal portion, such as a radiopaque marker, having a predetermined relationship with the peripheral opening.
In a second preferred embodiment, a catheter is provided for directing a guidewire substantially laterally with respect to a body passage within which the catheter is introduced. The catheter is an elongate member having proximal and distal ends, having a distal portion adapted for insertion within a body passage, and defining a longitudinal axis and an outer peripheral surface. A first lumen extends between the proximal end and a first axial opening in the distal end, and a second lumen extends between the proximal end and a second lateral opening in the distal portion proximate the distal end.
Preferably, the second lateral opening is located on the peripheral surface of the elongate member, and the second lumen includes a deflection ramp therein adjacent to the second lateral opening. In addition, the distal portion may include an angled step tapering to a distal tip, the second lateral opening being located on the angled step.
In another aspect of the present invention, devices are provided for releasably snaring a guidewire or other rail, e.g., to facilitate placement or manipulation of the guidewire. In a preferred embodiment, the snaring device includes an elongate member having proximal and distal portions, and having first and second lumens extending between the proximal and distal portions. The first lumen has a first distal opening proximate to a second distal opening of the second lumen on the distal portion.
A snaring member including a loop on its distal end is slidably received in the first lumen, the loop extending distally from the first distal opening and surrounding the distal portion of the elongate member such that the snaring member may be directed proximally and distally, the loop thereby substantially engaging and disengaging, respectively, an outer surface of the distal portion of the elongate member.
The loop may be biased to assume an enlarged substantially circular configuration, the substantially circular configuration preferably defining a predetermined diameter corresponding to a diameter of a lumen of a blood vessel. The corresponding distal portion of the elongate member has a diameter substantially smaller than the predetermined diameter. Preferably, the distal portion includes an angled step tapering to a distal tip, the first distal opening being located on the angled step, and the second distal op
Chang John
Flaherty J. Christopher
Garibotto John
Hayase Motoya
Kim Steven W.
Lyon & Lyon LLP
Shaver Kevin
Szmal Brian
Transvascular, Inc.
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