FLOPPY GUIDE WIRE WITH OPAQUE TIP

Abstract: A floppy guide wire for use in introducing catheters into vascular systems and having very flexible characteristics comprises an elongate flexible element (12) formed of a me­ tallic material. The element (12) has a cylindrical proximal portion (12a), a tapered intermediate portion (12b) and a flattened distal portion (12c). A coil (16) formed of a substan­ tially radiopaque material is secured to said element (12) and is generally concentric therewith. The coil (16) extends beyond the distal extremity of the flattened portion (12c) of the flexible element (12) and a rounded metallic protrusion (18) is carried by the distal extremity of the coil (16) and is spaced from the distal extremity of the flexible element (12). A safety wire (17) is disposed within the coil (16) and is se­ cured to the protrusion (18) and to the flexible elongate ele­ ment (12).

Description: FLOPPY GUIDE WIRE WITH OPAQUE TIP This invention relates to floppy guide devices or "wires" for use in introducing catheters into vascular systems and more particularly into cardiovascular systems in humans and which is provided with an opaque tip. Guide wires have heretofore been provided to facilitate the insertion of catheters into cardiovascular systems. In connection with such guide wires it has been found that it is difficult to introduce them into very small vessels and particularly into partially occluded segments of such vessels. There is therefore a need for an improved guide wire which can be successfully introduced into the small vessels in vascular systems and more particularly to provide one which is very flexible or floppy to facilitate travel in the vessel and in particular a vessel which is highly tortuous. Thus, it would be desireable to provide a floppy guide wire for catheters which can be introduced into small vessels in vascular systems and particularly in cardiovascular systems in humans and which has torque capabilities. It is also desirable to provide a floppy guide wire of the above character which has a very flexible distal end, preferably the very flexible distal end having a greater freedom of movement or direction in one plane than in other directions. According to the present invention there is provided a guide device comprising an elongate flexible element formed of a metallic material, said element having a cylindrical proximal portion, a tapered intermediate portion and a flattened distal portion, a coil formed of a substantially radiopaque material secured to said element and being generally concentric with the element, said coil extending beyond the distal extremity of the flattened portion, a rounded metallic protrusion carried by the distal extremity of the coil and being spaced from the distal extremity of the flexible elongate element and a safety wire disposed within the coil and secured to the protrusion and to the flexible elongate element. The invention will now be further described by way of example only with reference to the accompanying drawings, in which: Figure 1 is a side elevational view partially in cross section of a floppy guide device incorporating the present invention; Figure 2 is a cross sectional view taken along the line 2-2 of Figure 1; and Figure 3 is an enlarged view of the distal portion of the floppy guide device shown in Figure 1. The floppy guide wire of the present invention for use in inserting catheters consists of an elongate element formed of a metallic material having torsional capabilities. The element is provided with a cylindrical proximal portion, a tapered intermediate portion and a flattened distal end portion. A coil formed of a substantially radiopaque material is secured to the element so that it is concentric with the element and extends beyond the distal extremity of the element. A rounded protrusion is carried by the distal extremity of the coil. A safety wire is disposed within the coil and is secured to the protrusion and to the flexible elongate element. More particularly as shown in Figures 1, 2 and 3, the floppy guide device or "wire" 11 consists of a flexible elongate element 12 formed of a suitable metallic material having a high torsional strength such as stainless steel. Other materials can be utilized such as certain carbon steels as well as titanium or beryllium copper. The flexible elongate element 12 can be in the form of a wire-like hollow cylindrical element or in the form of a wire-like cylindrical core. One particular material utilized for the flexible elongate element 12 has been No. 304 stainless steel which includes approximately 20% chromium and 10% nickel and has a minimum of 240 ksi tensile strength. The material is preferably work-hardened by drawing .15 inch (3.8 mm) stainless steel wire down to wire having a diameter of .01 inches (0.25 tin). The wire after being work-hardened is straightened and cut to the desired length. Thereafter, it is then centerless ground and the tip flattened to provide the conformation shown in Figure 1. The guide wire 11 has a suitable length which depends upon the application for which it is used. As a typical guide wire it can have a length of approximately 175 centimeters plus or minus 5 centimeters. The flexible elongate element 12 has a total length of slightly less than the 175 centimeters as, for example, a length of approximately 173.5 centimeters for a purpose hereinafter described. The flexible elongate element 12 is provided with an elongate generally cylindrical proximal portion 12a which extends almost the entire length of the floppy guide wire 11. It is adjoined by an intermediate tapered portion 12b which in turn is adjoined by a distal flattened portion 12c. If desired, a cylindrical portion having a diameter of .002 inches (0.05 mm) could be substituted for the flattened portion. Thus it can be seen that the portions 12b and 12c form the distal portion of the flexible elongate element 12. The cylindrical portion 12a has suitable dimensions such as a diameter ranging from .005 to .012 inches (0.013 to 0.O.3mm) and preferably a diameter of apprcxImatelv .01 inches (0.25 mm). The tapered portion 12b tapers down frozen a larger diameter to a smaller diameter as, for example, down to .003 and .004 of an inch (0.076 and 0.102 mn).The tapered portion can have a suitable length as, for example, four centimeters plus or minus 2 centimeters. The flattened portion 12c can have a suitable length such as 5.5 centimeters plus or minus 2 centimeters. The flattened portion typically can be formed by centerless grinding portion to a uniform dimension of .003 to .004 inches (0.076 to 0.102mm) in diameter, after which this portion is stamped or rolled flat. When so flattened, the portion 12c can have a length of approximately 1.5 centimeters plus or minus 1 centimeter. It also can be characterized as having a thickness of appraimately .002 inches (0.05 mm) and a width fran .002 to .008 inches (0.05 to 0.2 mm) depending upon the diameter of the starting wire. Va n Ehe distal.extremity of the flexible elongate element has been flattened in this manner, it can be seen that this distal portion will have much greater flexibility of movement in a direction in a plane which is perpendicular to the width of the flattened portion than in other directions and in particular, parallel to the plane of the flattened portion. An elongate coil 13 formed of a suitable material such as stainless steel is coaxially disposed on the flexible elongate element 12 and extends substantially the entire length thereof from the proximal end to near the commencement of the tapered portion 12b. The coil 13 can be formed of wire having a diameter from .001 to .005 inches (0.025 to 0.127 mn) and preferably a diameter cf.003 inches (0.076 man). With such dimensions the coil wxld have an outer diameter ranging fran .007 inches (0.178nr) to .025 inches (0.64nun). The coil 13 is ttthtly wamd so that the turns are bottomed out or butt each other. In order to provide a smooth relatively slippery or unctuous surface, a coating 14 of a suitable material such as Teflon is provided on the coil 13 to generally provide for lubricity when exposed to blood and contrast agents which are notably sticky. Another elongate coil 16 is provided which adjoins the coil 13. The coil 16 is formed of material which is substantially opaque to x-rays. For that reason it should be formed of a material wich has a density of at least 13 grams/cm3. Suitable materials meeting this requirement include gold, tantalum, tungsten, platinum, iridium, rhenium and alloys of these materials. One coil 16 formed of this material was formed from a platinum alloy wire having dimensions substantially the same as the dimensions of the wire utilized for forming the coil 13. The proximal portion of the coil 16 was formed with turns which are bottomed out on each other. However, near the distal end of the coil 13, the turns are stretched or spaced apart a suitable distance as, for example, .003 inches (0.076 mm} plus or minus .0003 inches (0.0076 mm). This spacing in the platimun coil provides additional flexibility in the distal extremity of the platinum coil. The distal extremity of the coil 13 and the proximal extremity of the coil 16 can be threaded together as shown particularly in Figures 2 and 3 so that a connection is formed therebetween. Alternatively, if desired, the two coils 13 and 16 can have these same ends butted together. A safety ribbon 17 formed of a suitable material such as tungsten is provided and is disposed internally of the coil 13. It can have suitable dimensions such as a thickness of .001 inches (0.025 mm) and a width of .003 inches (0.076). A metallic rounded?#rotrusion 18 in the form of a gold alloy slug 18 is disposed in the distal extremity of the coil 16. Typically, this is formed by brazing a small slug 18 into the distal extremity of the coil. As can be seen, the safety ribbon 17 is brazed into the slug 18 and extends rearwardly from the protrusion or slug 18 into a region where it overlies the flexible elongate element 12 as, for example, the tapered portion 12b of the element 12. The distal extremity of the coil 13, the proximal extremity of the coil 16 and the proximal extremity of the safety ribbon 17 and the tapered portion of the element 12 are bonded into a unitary assembly by a brazing compound 19. A rounded protrusion 22 formed of a suitable material -Eca#tas--a-#old coil-like preform 22 is secured to the proximal extremity of the coil 13 by suitable means fiuch as brazing. From the construction herein described, it can be seen that the guide wire 11 has a substantially continuous ¯d#i.axneter -througho#t its entire length. The transitionpoint between the stainless steel coil 13 and the platinum coil 16 can only be denoted by the brazing 19. The brazing 19 is applied in such a manner that a smooth surface is provided by the outer surface of the brazing so that a substantially smooth, relatively slippery exterior surface is provided by the guide wire 11. The guide wire 11 hereinbefore described can be utilized as a guide wire for inserting catheters in vascular systems and particularly into cardiovascular systems. The entire guide wire is relatively floppy and can be readily introduced in a manner well known to those skilled in the art. The distal extremity of the guide wire is very flexible. The flexibility is enhanced because the distal extremity of the coil 16 is spaced from the portion 12c of the flexible element 12. The tungsten safety ribbon 17 in addition to providing a safety ribbon which prevents extension of the coil 13 when it is being retracted and from becoming separated from the flexible elongate element 12, also provides means which can be shaped by hand so as to provide a predetermined conformation to the distal extremity of the coil 16. Thus in addition to being very flexible, the distal extremity of the guide wire 11 can be preformed. The flattened portion 12c of the element 12 provides extreme flexibility in one direction, namely, in a direction perpendicular to the plane of the flattened portion 12c while at the same time providing some rigidity in other directions to facilitate ziegotiation of difficult regions in the vascular system. Since the distal extremity of the guide wire 11 is relatively light, it floats in a moving blood stream as, for example, one encountered in the human cardiovascular system which facilitates movement of the guide wire through the vessels of the vascular system. The construction of the guide wire is relatively simple and is one which can be repeatably manufactured with consistency. In summary, the guide wire is floatable in the blood stream. The tips can be preformed by the doctors or radiologists so as to be able to enter different areas of the cardiovascular system. The guide wire is still stiff enough so it can be used as a guide and still floppy enough so that it will not penetrate the wall of the vessel. The guide wire is sufficiently small that it can penetrate lesions and still permit blood flow through an occluded vessel. The tip of the guide wire is substantially radiopaque so that its travel can be observed under conventional fluoroscopy. By way of example, in the event that the guide wire reaches a dead end, a shepherd's hook will be formed in the end of the guide wire which can be observed on the fluoroscope. Because of the ability of the distal extremity of the guide wire to float, it can find and pass through eccentric openings in the vessels.

Claims: CLAIMS: 1. A guide device comprising an elongate flexible element formed of a metallic material, said element having a cylindrical proximal portion, a tapered intermediate portion and a flattened distal portion, a coil formed of a substantially radiopaque material secured to said element and being generally concentric with the element, said coil extending beyond the distal extremity of the flattened portion, a rounded metallic protrusion carried by the distal extremity of the coil and being spaced from the distal extremity of the flexible elongate element and a safety wire disposed within the coil and secured to the protrusion and to the flexible elongate element. 2. A guide device as claimed in claim 1 together with an additional coil formed of a metallic material, said additional coil being disposed on the proximal extremity of the flexible elongate element and adjoining the first named coil. 3. A guide device as claimed in claim 1 or claim 2 wherein said first named coil is formed of a platinum alloy. 4. A guide device as claimed in claim 2 or claim 3 wherein the first named coil and said additional coil are threaded together and a brazing compound bonds the proximal extremity of the first named coil and the distal extremity of the additional coil into a unitary assembly. 5. A guide device as claimed in any one of claims 1 to 4 wherein the turns of the distal extremity of the first named coil are spaced apart to provide additional flexibility therein. 6. A guide device as claimed in any one of claims 1 to 5 wherein said safety wire is formed of a pliable metallic material, said safety wire being capable of being shaped to preform the tip of the device.

Inventors: MORRISON, DAVID W., SAMSON, WILFRED J.
Applicants: ADVANCED CARDIOVASCULAR SYSTEMS, INC.
Application year: 1984
Main classification: A61M25
IPC codes: A61M25, A61B17