Surgery – Diagnostic testing – Flexible catheter guide
Reexamination Certificate
2001-04-25
2004-06-29
Robert, Eduardo C. (Department: 3732)
Surgery
Diagnostic testing
Flexible catheter guide
C600S435000
Reexamination Certificate
active
06755794
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to the field of intravascular leads and catheters. More specifically, the present invention relates to an adjustable stylet for use in positioning such leads and catheters.
BACKGROUND OF THE INVENTION
Stylets and guidewires are used to control the manner in which intravascular leads and catheters are introduced into the veins or arteries of the body. Although both kinds of devices are often thought of as simply very small wires, the purpose and operation of stylets is significantly different as compared to guidewires.
Conventional intravascular procedures typically involve an initial step of introducing and routing a guidewire through a patient's vascular system to provide a rail or track along which additional intravascular devices may be introduced. Once a guidewire is in place, a sheath is routed over at least a portion of the guidewire to provide a larger opening into the vein or artery and sometimes to protect the inside walls of the vessels along the route of the guidewire. With the sheath in place, the guidewire may be removed or may remain in place as additional intravascular devices such as intravascular leads and catheters are introduced into the patient's vascular system.
To better accomplish the purpose of a guidewire of providing a track along the patient's vascular system for other intravascular devices, it is desirable that the guidewire have a region at the tip of the guidewire, referred to as the distal end, that is extremely flexible. Preferably, the guidewire has the ability to vary the flexibility of the distal tip and/or deflect the distal tip so as to aid in routing the guidewire through the patient's vascular system. U.S. Pat. Nos. 4,215,703, 4,456,017, 4,719,924, 4,886,067 and 5,060,660 describe designs for guidewires that use an internal tensioning member or pull wire to alter the characteristics of the non-expandable distal tip and/or to deflect the distal tip. U.S. Pat. Nos. 4,271,845 4,822,345, 5,605,162, 5,762,615, 5,851,203, 5,957,903 and 6,183,420 describe various designs for guidewires with adjustable stiffness by moving a core member axially within the distal region of the guidewire. U.S. Pat. Nos. 5,938,623 and 6,039,743 describe a guidewire with adjustable stiffness that is controlled by running electricity through a memory metal wire tip. U.S. Pat. No. 5,341,817 describes a guidewire extension arrangement in which a smaller inner extension can be pushed out of a larger core segment to extend the distal end of the guidewire. U.S. Pat. Nos. 4,846,174 and 5,338,301 describe guidewires with a core member that can be extended to axially stretch an angioplasty balloon at the distal tip. In a similar manner, U.S. Pat. Nos. 3,841,308 and 4,759,748 describe catheters that utilize a core member to axially stretch a coiled section at the distal end of the catheter for purposes of controlling delivery of a fluid.
In contrast to the guidewire which serves as a track over which other intravascular devices are routed, a stylet is used within an internal lumen of an intravascular device both to push that device through the vascular system and to steer the device as it is being pushed. Although some intravascular devices are designed to steer themselves using internal pull wires, almost all leads, most catheters and some guidewires have an inner channel or lumen into which a stylet is inserted. In addition to pushing the intravascular device through the vascular system by engaging the distal end of the device, the stylet also serves to deflect the distal end of the intravascular device so as to steer the distal end through the vascular system. Unlike the lead, catheter or guidewire, which has a distal region that is flexible and floppy, the stylet must be stiffer and more rigid so as to enable the stylet to push the lead or catheter through the patient's vascular system. Conventionally, stylets having different bends on the distal end are used at different points of advancing the lead or catheter to a desired location. For straight segments of a vessel a straight stylet is used, whereas a stylet with a curved distal tip is used to navigate the lead or catheter through a curved portion of a vessel. U.S. Pat. No. 2,118,631 shows an early stylet formed of coils of flat wire welded to plugs at both ends that could be bent by the physician into either a straight or curved configuration at its distal end prior to insertion into the lumen of a catheter or the like. In a more recent type of stylet, an operator controls the direction of deflection of the tip of the stylet while it is in place in the lumen, which in turn controls the direction of the cardiac lead or catheter as it is moved along the veins or arteries. An example of a stylet with such a deflecting tip is shown in U.S. Pat. No. 5,824,031. Other examples of steerable stylets can be found in U.S. Pat. No. 5,873,842 and PCT Publ. No. WO 00/22981.
The more control and flexibility an operator has over an intravascular device, the easier it is to operate that device. In the case of stylets, the physical demands of engaging the distal end of a lumen of an intravascular device so as to push that device through the vascular system impose constraints on the beam strength of the device that are much different than the constraints encountered for a guidewire, catheter or lead. Most guidewires are constructed from a tapered core wire with a coiled round wire wrapped around this tapered core wire in order to achieve the necessary flexibility in the distal region of the guidewire. Stylets, on the other hand, are generally constructed of a solid wire of uniform diameter without any coils around this wire in order to achieve the necessary strength and rigidity required over the entire length of the device so as to function as a stylet. Because of these differences, the techniques for improving control and flexibility that have been utilized for guidewires, catheters and leads are not generally applicable for the design of stylets. It would be desirable to provide for a stylet with improved flexibility and control without the need for changing stylets during a procedure to obtain different orientations of the distal tip of the stylet.
SUMMARY OF THE INVENTION
The present invention is an adjustable stylet. The stylet includes a core wire having a portion surrounded by a compression member preferably comprised of a flat wire spring. Depending upon the configuration, compression or relaxation of the compression member in response to forces at the tip or handle of the stylet results in adjustments to the characteristics of the stylet. In a first embodiment, the stiffness of the stylet is adjustable. In a second embodiment, the length of the stylet is adjustable. In a third embodiment, both the stiffness and the length of the stylet are adjustable.
Unlike most guidewires that are so flexible the guidewire will fall over when grasped only by the ends, the stylet in accordance with the present invention requires a much greater rigidity such that the stylet forms an arc that generally stands up and does not fall over when the stylet is grasped only by the ends. The present invention utilizes a core wire that has a relatively uniform beam strength over its axial length so as to provide the necessary rigidity and strength required for a stylet. The compression member augments the characteristics of the core wire in a manner that is adjustable so as to also be able to more closely emulate the desired characteristics of an adjustable guidewire.
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pat
Fredrikson & Byron , P.A.
Ramana Anuradha
Robert Eduardo C.
Synovis Life Technologies, Inc.
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