Improved hybrid catheter guide wire apparatus and method

Abstract: A hybrid catheter guide wire includes an elongate solid body having a tapered distal end over which is disposed a tubular section--about which a catheter may be threaded for guidance to a target location in a vasculature passageway of a body. Cuts are formed either by saw-cutting, laser cutting or etching at spaced-apart locations along at least a portion of the tubular section to increase its lateral flexibility, while maintaining its rotational torquability, and to control the direction and degree of flexure.

Description: BACKGROUND OF THE INVENTION 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 Once the catheter is in place, the guide wire may be withdrawn, depending upon the therapy to be performed.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. Patent 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. Patent No. 5,411,483. Two other earlier publications that are relevant to the present invention are U.S. Patent No. 5,095,915 and European Patent No. 778039. Both of these patent documents disclose hybrid catheters, but they do no comprise all the same elements of the present invention. EP 778040 discloses a hollow guide wire apparatus wherein the tubular guide wire is made of nickel-titanium alloy. The present invention addresses the problem of improving the flexibility of the guide wire whilst providing sufficient torsional stiffness whereby improved advancement of the guide wire through the subjects body is permitted. SUMMARY OF THE INVENTION According to the present invention there is provided a guide wire for navigating through anatomy to guide a catheter to a predetermined location as claimed in claim 1. According to a further aspect of the present invention there is provided a method of making a guide wire as claimed in claim 19. The reduced cross-sectional dimension of guide wire according to the invention provides improved flexibility whilst maintaining the required torsional stiffness. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects, features and advantages of the invention will be become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which: FIG. 1 shows a side, fragmented, partially cross-sectional view of one embodiment of a catheter guidewire apparatus made in accordance with the principles of the present invention; and FIGS. 2A and 2B show respectively a side, fragmented, partially cross-sectional view, and an end cross-sectional view taken along lines B-B, of another embodiment of the present invention. DETAILED DESCRIPTION FIG. 1 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 (but could be reduced more abruptly) to a thin, narrow section 212. Mounted over the thin, narrow section 212 is a tubular section 216 whose proximal end 218 abuts 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. 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. Patent 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 could be from about 203 to 965 µm (0.008 to 0.038 inches), as could be the outside diameter of the tubular section 216. A preferred diameter is 356 µm (0.014 inches), with the interior diameter of the hollow of the tubular section 216 being about 216 µm (0.0085 inches). Of course, the outside diameter of the tubular section 216 could be greater or less than that of the larger part of the catheter guide wire 200. 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. Finally, a radiopaque or MRI sensitive coil or flexible plastic tube could be disposed about the narrow section 212 of the guide wire, within the tubular section 216, to provide a much larger, more readily viewable marker. 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 could also be made of a lubricious, hydrophilic polymer, 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 FIG. 1, 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. FIGS. 2A and 2B show respectively a side, fragmented, partially cross-sectional view and an end cross-sectional view of another embodiment of the hybrid catheter guide wire apparatus of the present invention. There shown is a guide wire 300 which tapers (but may be abruptly reduced) at its distal end to a thin, narrow section 304. A tubular section 308 is mounted about the thin, narrow section 304, as with the FIG. 1 embodiment, so that its proximal end 312 abuts the sloping portion 316 (or other portion) of the distal end of the guide wire 300, and its distal end 320 is generally contiguous with the termination of the thin, narrow section 304. Disposed about the termination of the thin, narrow section 304 and within the distal end 320 of the tubular section 308 is a platinum, radiopaque coil 324. The coil 324 is held in place to the termination of the thin, narrow section 304 and the distal end 320 of the tubular section 308 by a suitable adhesive. Another coil 328 is disposed about the sloping portion 316 of the guide wire 300 near the proximal end 312 of the tubular section 308, to serve as a spacer or bushing between the tubular section 308 and the guide wire 300. Advantageously, the coil 328 is made of platinum. The coil 328 is held in place by a suitable adhesive. Thus, the tubular section 308 is held in place about the thin, narrow section 304 by adhesive both at the proximal end 312 and the distal end 320. The coil 324 could be extended rearwardly, or the coil 328 could be extended forwardly, to loosely fill the space between the narrow section 304 and tubular section 308 and thus provide greater viewability of the radiopaque marker. Alternatively, an MRI sensitive or radiopaque flexible tube could be disposed in the space. As with the FIG. 1 embodiment, the guide wire 300 advantageously is constructed of stainless steel while the tubular section 308 is constructed of nickel-titanium alloy. Cuts, slots, gaps or openings 332 may be formed along at least a portion of the exterior surface of the tubular section 308 to achieve additional desired lateral flexibility. The dimensions of the embodiment of FIGS. 2A and 2B may be similar to those of the FIG. 1 embodiment. A typical length of the tubular section 308 is from 8 to 20 centimeters. Additionally, the distal end of the tubular section 308 may be preshaped with a curve to allow for directing the guide wire around curves and bends, and may be formed to include MRI sensitive markers or bands (in addition to the radiopaque coils 324 and 328), as with the FIG. 1 embodiment. 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 scope of the present invention and the appended claims are intended to cover such modifications and arrangements.

Claims: A guidewire for navigating through anatomy to guide a catheter to a predetermined location, the guidewire comprising an elongate body (200; 300) having a proximal end (204) and a distal end (208), a tubular member (216; 308) made of nickel-titanium alloy and having a proximal end (218; 312) and a distal end (226; 320), the body (200; 300) extending proximal from the tubular member (216; 308), and a plurality of slots (230; 332) formed into the tubular member (216; 308) along at least a portion of the tubular member (216; 308); and characterized in that the body (200; 300) has a section of reduced cross-sectional dimension (212; 304), and at least part of the section of reduced cross-sectional dimension (212; 304) is located inside the tubular member (216; 308). The guidewire of claim 1, characterized in that the slots (230; 332) are configured to reduce the bending stiffness of the tubular member (216; 308). The guidewire of claim 1 or 2, characterized in that the guidewire has a rounded distal tip (226). The guidewire of claim 1, 2, or 3, characterized in that the body (200; 300) substantially comprises stainless steel. The guidewire of any of the preceding claims, characterized in that the tubular member (216; 308) has an outside diameter that is substantially constant along the tubular member (216; 308) and the tubular member (216; 308) has an inside diameter that is substantially constant along the tubular member (216; 308). The guidewire of any of the preceding claims, characterized in that the body (200; 300) is solid. The guidewire of any of the preceding claims, characterized in that the body (200; 300) is at least partially tapered. The guidewire of any of the preceding claims, characterized in that the guidewire further comprises space between the body (200; 300) and the tubular member (216; 308), along at least part of the length of the tubular member (216; 308) and along at least part of the length of the body (200; 300). The guidewire of any of the preceding claims, characterized in that the section of reduced cross-sectional dimension (212; 304) is an extension of the larger part of the body (200; 300) and thus made of the same material. The guidewire of any of the preceding claims, characterized in that the guidewire further comprises a coil (324; 328) located inside the tubular member (216; 308), and that the coil (324; 328) is disposed between the body (200; 300) and the tubular member (216; 308). The guidewire of claim 10, characterized in that the coil (324; 328) is radiopaque. The guidewire of claims 10 or 11, characterized in that at least part of the body (200; 300) is inside the coil (324; 328) and the body (200; 300) extends proximal from the coil (324). The guidewire of any of the preceding claims, characterized in that , the tubular member (216; 308) is attached to the body (200; 300) at the proximal end (218; 312) of the tubular member (216; 308). The guidewire of any of the preceding claims, characterized in that the tubular member (216; 308) is attached to the body (200; 300) at the distal end (226; 320) of the tubular member (216; 308). The guidewire of any of the preceding claims, characterized in that the body (200; 300) has an outside diameter near the proximal end (204) of the body (200; 300) that is at least as large as the outside diameter of the tubular member (216; 308). The guidewire of any of the preceding claims, characterized in that the body (200; 300) has an outside diameter near the proximal end (204) of the body (200; 300), that is greater than 203 µm (0.008 inches) but less than 965 µm (0.038 inches). The guidewire of any of the preceding claims, characterized in that at least some portion of the tubular member (216; 308) has greater lateral flexibility than the proximal end (204) of the body (200; 300). The guidewire of any of the preceding claims, characterized in that the distal end (208) of the guidewire is configured at a location where the guidewire includes the tubular member (216; 308) to enable transfer of a moment force from an adjacent proximal location along the guidewire (200; 300) toward a more distal location along the guidewire, and at the same time to minimize resistance to a lateral force tending to bend the guidewire distal portion (208). A method of making a guidewire for navigating through anatomy to guide a catheter to a predetermined location, the method comprising in any order at least the steps of: obtaining an elongate body (200; 300) having a proximal end (204) and a distal end (208); obtaining a nickel-titanium alloy tubular member (216; 308) having a first end (218; 312) and a second end (226; 320); attaching the first end (218; 312) to the body (200; 300), with at least part of the body (200; 300) inside the tubular member (216; 308); and attaching the second end (226; 320) to the body (200; 300) at the distal end (208). The method of claim 19, the step of attaching the second end (320) further comprising disposing a coil (324) between the body (300) and the tubular member (308). The method of claim 20, characterized in that the coil (324) is radiopaque. The method according to any of claim 19 to 21, further comprising the step of shaping the body (200; 300) to have at least a first portion (204) having a first outside diameter, and a second portion (212; 304) having a second outside diameter, the second outside diameter being less than the first outside diameter, whereby the attachment step is such that the first portion (204) of the body (200; 300) extends proximally from the tubular member (216; 308), and the second portion (212; 304) is located at least partially inside the tubular member (216; 308). The method of claim 22, characterized in that the body (200; 300) is tapered, at least from the first outside diameter to the second outside diameter. The method according to claim 22 or 23, characterized in that the tubular member (216; 308) has a third outside diameter that is substantially constant along the tubular member (216; 308), the tubular member (216; 308) has an inside diameter that is substantially constant along the tubular member (216; 308), the second outside diameter is less than the inside diameter; and the third outside diameter is less than or equal to the first outside diameter. The method according to any of claims 19 to 24 further comprising the step of forming a plurality of slots (230; 332) in the tubular member (216; 308) along at least a portion of the tubular member (216; 308). The method of claim 25, characterized in that the slots (230; 332) are configured to reduce the bending stiffness of the tubular member (216; 308). The method of claim 25 or 26 characterized in that the slots (230; 332) are spaced varying distances apart along the tubular member (216; 308). The method of claim 25, 26, or 27, characterized in that the slots (230; 332) are formed by saw-cutting. The method of claim 28, characterized in that the saw-cutting is performed with a diamond-grit embedded semiconductor

Inventors: DAVIS CLARK, JACOBSEN STEPHEN C, LIPPERT JOHN, DAVIS, CLARK, JACOBSEN, STEPHEN C., LIPPERT, JOHN
Applicants: PRECISION VASCULAR SYSTEMS INC, PRECISION VASCULAR SYSTEMS, INC.
Application year: 1998
Main classification: A61M25
IPC codes: A61M25