Hybrid Catheter Guide Wire Apparatus

This invention relates to a hybrid catheter guide wire apparatus with improved torque and flexure characteristics.

Catheter guide wires have been used for many years to "lead" or "guide" catheters to desired target locations in the human body's vasculature. The typical guide wire is from about 135 centimeters to 195 centimeters in length, and is made from two primary pieces--a stainless steel core wire, and a platinum alloy coil spring. The core wire is tapered on the distal end to increase its flexibility. The coil spring is typically soldered to the core wire at a point where the inside diameter of the coil spring matches the outside diameter of the core wire. Platinum is selected for the coil spring because it provides radiopacity for X-ray viewing during navigation of the guide wire in the body, and it is biocompatible. The coil spring also provides softness for the tip of the guide wire to reduce the likelihood of puncture of the anatomy.

Navigation through the anatomy is achieved by viewing the guide wire in the body using X-ray fluoroscopy. The guide wire is inserted into a catheter so the guide wire protrudes out the end, and then the wire and catheter are inserted into a vessel or duct and moved therethrough until the guide wire tip reaches a desired vessel or duct branch. The proximal end of the guide wire is then rotated or torqued to point the curved tip into the desired branch and then advanced further. The catheter is advanced over the guide wire to follow or track the wire to the desired location, and provide additional support for the wire. Once the catheter is in place, the guide wire may be withdrawn, depending upon the therapy to be performed. Oftentimes, such as in the case of balloon angioplasty, the guide wire is left in place during the procedure and will be used to exchange catheters.

As the guide wire is advanced into the anatomy, internal resistance from the typically numerous turns, and surface contact, decreases the ability to advance the guide wire further. This, in turn, may lead to a more difficult and prolonged procedure, or, more seriously, failure to access the desired anatomy and thus a failed procedure. A guide wire with both flexibility and good torque characteristics (torsional stiffness) would, of course, help overcome problems created by the internal resistance.

Among the approaches suggested in the prior art for increasing the flexibility of the tip of a guide wire is that of cutting axially spaced grooves in and near the tip, with the depths of the grooves increasing toward the tip. See U.S. Pat. No. 5,437,288. The use of cuts to increase flexibility on one side only of a tubular guide wire is disclosed in U.S. Pat. No. 5,411,483.

It is an object of the invention to provide an improved catheter guide wire apparatus.

It is also an object of the invention to provide such apparatus which exhibits both torsional stiffness, bending flexibility, and longitudinal strength.

It is a further object of the invention to provide such apparatus which is simple in design and construction.

It is another object of the invention, in accordance with one aspect thereof, to provide a catheter guide wire apparatus with improved flow directability characteristics.

The above and other objects of the invention are realized in a specific illustrative embodiment of a hybrid catheter guide wire apparatus formed of a thin elongate solid body of material which tapers to a distal termination, and a thin elongate tubular body of material attached co-linearly to the distal end of the solid body. The tubular body is constructed to have greater lateral flexibility than the solid body, while retaining torsional stiffness. Cuts may be formed in the tubular body, transversely thereof to give the guide wire flexibility without significantly reducing torsional stiffness or strength.

The above and other objects, features and advantages of the invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawing which shows a side, fragmented, partially cross-sectional view of one embodiment of a catheter guide wire apparatus made in accordance with the principles of the present invention.

The drawing shows a side, fragmented, partially cross-sectional, view of one embodiment of a hybrid guide wire 200 made in accordance with the present invention. A pin vise type torquing chuck 206 is shown attached to a proximal end 204 in the usual manner. The guide wire 200 also includes a distal end 208 which tapers to a thin, narrow section 212. Mounted over the thin, narrow section 212 is a tubular section 216 whose proximal end 218 abuts but is not attached to the sloping portion 222 of the distal end 208 of the proximal guide wire segment, and whose distal end 226 is rounded to reduce the chance of damage and trauma to the vasculature when the guide wire is being threaded therein. As is shown in FIG. 1, the tubular section 216 is attached to the narrow section 212 only, and preferably is attached at the distal end of the narrow section.

Advantageously, the guide wire 200 is constructed of stainless steel and the tubular section 216 is constructed of nickel-titanium alloy to provide for greater lateral flexibility. Additional lateral flexibility can be achieved by providing cuts, slots, gaps or openings 230 along at least a portion of the exterior surface of the tubular section 216. These cuts may be formed by saw cutting (e.g., diamond grit embedded semiconductor dicing blade), etching (for example using the etching process described in U.S. Pat. No. 5,106,455), laser cutting, or electron discharge machining. Provision of the cuts in the tubular section increases lateral flexibility in the guide wire, while maintaining torsional stiffness.

The thin, narrow section 212 of the guide wire 200 is shown in the drawing as being an extension of the larger part of the body and thus made of the same material, the section 212 could also be made of a carbon fiber or polymer strand, attached to the larger part of the body 200 (for example, by a suitable adhesive), and this would provide excellent longitudinal strength with very little lateral stiffness. Advantageously, the diameter of the larger proximal part of the catheter guide wire 200 would be 0.014 inches, as would be the outside diameter of the tubular section 216, with the interior diameter of the hollow of the tubular section 216 being about 0.0085 inches.

The distal end of the tubular section 216 may be preshaped with a curve to allow for directing the guide wire around curves and bends. Also formed on the distal end 226 of the tubular section 216 is a radiopaque or MRI sensitive marker or band 234. The band 234 may be gold or platinum alloy (for X-ray fluoroscopy) or gadolinium or dysprosium, or compounds thereof (for MRI) and may be formed on the distal end 226 by deposition, wrapping or use of shape memory alloy (NiTi) effect to "lock" the band around the end. Alternatively, a radiopaque or MRI sensitive plug 238 could be disposed in the distal end 226 of the tubular section 216 and attached to the distal end of the thin, narrow section 212 of the solid body portion of the guide wire 200 (or to the carbon fiber or polymer strand) to both serve as a marker and to assist in holding the tubular section 216 in place over the thin, narrow section 212. Glue or other adhesives could also be used to hold the tubular section 216 in place, including radiopaque glue.

To improve slidability of the guide wire 200 in a vasculature passageway, the exterior surface of the guide wire, including tubular section 216, could be sandblasted, beadblasted, sodium bicarbonate-blasted, electropolished and/or coated with a lubricious coating such as a silicon based oil and/or polymer or a hydrophilic polymer. Alternatively, a sleeve could be disposed over the entire length of the guide wire where the sleeve were also made of a hydrophilic or other polymer, and then coated.

Cuts 230 of various shapes may be selectively spaced along and about the tubular section 216 to provide for selective bending of the tubular section, while maintaining good torsional stiffness. For example, the cuts could be formed at circumferentially-spaced locations about the tubular section 216 and could be formed with various shapes, the depth and thickness of which could be chosen to again allow for preferential bending of the section.

In the embodiment of the drawing, the guide wire 200 can be made "flow directable" by providing a highly flexible distal end. "Flow directability" means that the distal end of the guide wire tends to "flow" with the blood around curves and bends in a vasculature passageway.

It is to be understood that the above-described arrangements are only illustrative of the application of the principles of the present invention. Numerous modifications and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of the present invention and the appended claims are intended to cover such modifications and arrangements.