Abstract:
A high performance coil over-core guide wire. The guide wire incorporates a nickel-titanium core with a stainless steel coil to provide a wire with improved kink resistance and good pushability.

Description:
This is a continuation of application Ser. No. 09/078,946, filed May 14, 1998 now U.S. Pat. No. 6,306,105. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to guide wires and their methods of manufacture. Specifically, the present invention relates to guides wires made with a solid core and surrounded by a coil. Those skilled in the art will recognize the benefits of applying the present invention to similar fields not discussed herein. 
     BACKGROUND OF THE INVENTION 
     Guide wires are used in a variety of medical applications including intravascular, gastrointestinal, and urological. A common vascular application is Percutaneous Transluminal Coronary Angioplasty (PTCA). This procedure can involve inserting a guide wire through an incision in the femoral artery near the groin, advancing the guide wire over the aortic arch, into a coronary artery, and across a lesion to be treated in the heart. Similarly, angioplasty performed in other parts of the anatomy is called Percutaneous Transluminal Angioplasty (PTA) and may also involve the use of a guide wire. Typical vascular guide wires are 50 cm or 300 cm in length, and are 0.010-0.038 inches in diameter depending upon the application. 
     Common gastrointestinal uses of guide wires include endoscopic procedures in which an endoscope may be inserted into the mouth and advanced through the esophagus to the bile duct, the cystic duct, or the pancreatic duct. A guide wire is then threaded through a lumen in the endoscope and into the bile duct, cystic duct, or pancreatic duct. Once the distal tip of the guide wire is located in a position desired to be treated, a catheter having a medical instrument on it distal end is advanced over the guide wire and to the treatment area. The guide wire and the catheter may then be observed through the endoscope as treatment occurs. 
     Urological uses of guide wires include the placement of ureteral stents. Ureteral stenting is required when the normal flow of urine from the kidney into the bladder is compromised perhaps by tumor growth, stricture, or stones. Generally, the procedure involves the insertion of a ureteroscope through the urethra and into the bladder. A guide wire is then advanced through the ureteroscope and into a ureter. The wire is then forced through the compromised portion of the ureter. Once the guide wire is in place, a ureteral stent is advanced over the guide wire and into position in the ureter. The guide wire may then be removed and the stent will maintain the patency of the fluid path between the kidney and the bladder. The procedures described above are but a few of the known uses for guide wires. 
     Pushability, kink resistance, torqueability and bendability are closely related and important features of a guide wire. It is important that force applied at the proximal end of a guide wire is completely transferred to the distal end of the guide wire. Very stiff wires often provide good pushability (axial rigidity) but poor kink resistance. Kink resistance is measured by the ability of the guide wire to be forced into a relatively tight bend radius without permanently deforming the wire. A guidewire must exhibit good bendability. This characteristic is a balance between adequate flexibility to navigate a tortuous lumen and suitable rigidity to support tracking of another device such as a catheter. Torqueability is closely related to the torsional rigidity of the wire and is ultimately demonstrated by how well rotation imparted to the proximal end of the guide wire is translated to the distal end of the guide wire. 
     Conventional guide wires are made of carbon steel or stainless steel. More recently, guide wires made of super-elastic alloys have been used. A super-elastic or pseudoelastic metal guide wire was taught in U.S. Pat. No. 4,925,445 to Sakamoto. In U.S. Pat. Nos. 5,238,004 to Sahatjian and 5,230,348 to Ishibe the use of an elastic metal alloy was taught. Sahatjian &#39;004 further teaches that elastic metals may be heat treated to form bends in the wire core and that centerless grinding may be used to create certain wire profiles. 
     Several different types of guide wires are well known in the art. One type of wire is characterized by a solid metal core surrounded by a metal coil. Typical metals for the core may include spring steels and stainless steels. The distal tip of the core may also be ground to a taper to provide added flexibility near the tip. Coils may be made of the same variety of metals used as core materials. The coil may be made of round wire or flat wire and may surround the entire length of the core or only a portion of the core. The coil usually is formed by helically wrapping the wire around a mandrel, removing the mandrel, and inserting the core into the coil. The pitch of the wire may be varied along the length of the coil to vary the stiffness of the coil. 
     High performance guide wires usually possess high kink resistance and excellent wire movement. The basic construction of a high performance wire is a Nitinol core surrounded by a lubricious coating. Unfortunately, Nitinol guide wires suffer from diminished pushability because the highly elastic Nitinol absorbs some of the force imparted to the proximal end of the wire. An improved high performance wire would provide better pushability to conventional super-elastic wires. 
     Traditional coil over core wires provide good axial stiffness and hence improved pushability. Traditional coil over core wires also provide dramatically improved kink resistance over stainless steel wires. However, because the coils tend to wind up on torque, coil over core wires tend to provide reduced torque transmission. Therefore, it would be advantageous to provide a coil over core wire with the torque transmission of a high performance wire. 
     SUMMARY OF THE INVENTION 
     The present invention overcomes the deficiencies of the prior art by providing a coil over core guide wire which has the kink resistance and wire movement of a super-elastic wire and the pushability and torque transmission of a coil over core wire. The guide wire has a nickel-titanium alloy core with a tapered distal tip. The core may be super-elastic or linear elastic. 
     A coil surrounds most of the core and may be bonded to the core. The coil may be stainless steel or nickel-titanium. The coil may be made of flat wire or round wire and may be made of a single strand or multifilar strands and may be a single coil or cross-wound coil. 
     The guide wire may further have a polymer tip which may be loaded with a radio-opaque material. The wire may also be coated with lubricious coatings. The polymer tip may also form a floppy tip without a safety ribbon. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross-section of a first embodiment of the guide wire. 
         FIG. 2  is a cross-section of a second embodiment of the guide wire. 
         FIG. 3  illustrates an example of a multifilar cross-wound coil. 
         FIG. 4  illustrates a cross-sectional view of a rectangular coil. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following detailed description should be read with reference to the drawings in which like elements in different drawing are numbered identically. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. 
     Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements. All other elements employ that which is known to those skilled in the field of the invention. Those skilled in the art will recognize that many of the examples provided have suitable alternatives that may also be used. 
       FIG. 1  shows a first embodiment of the guide wire  10 . Core  20  may be 50-450 cm in length and 0.008-0.038 inches in diameter depending on the medical application. The distal portion  25  of core  20  may be tapered to provide flexibility to guide wire  10 . Preferably the tapered distal portion  25  is formed by grinding 5-20 cm of core  20 . The tapered distal portion  25  may be ground into a conical shape with a circular cross-section or stamped such that it has a rectangular cross-section. 
     Core  20  may be formed of a super-elastic material such as the alloys of nickel and titanium, commonly known as Nitinol. While Nitinol is the most common super-elastic material, any of a variety of other super-elastic materials may be used for core  20 . Other alloys by chemical name include; CuAlNi, CuSn, CuZn, InTi, NiAl, FePt, MnCu, and FeMnSi. A detailed discussion of super-elastic alloys and their processing is presented in U.S. Pat. No. 4,925,445 to Sakamoto and is herein incorporated by reference. 
     In addition to super-elastic materials, linear-elastic materials may be used. Linear-elastic materials are describe in U.S. Pat. No. 5,238,004 to Sahatjian which is also incorporated by reference. In general, linear-elastic materials are composed of the same alloys above. However, different material processing strategies are used to provide a wire which has many of the important characteristics of a super-elastic material without some of the difficulties related to machining, specifically grinding. As such, core  20  may preferably be formed of a linear-elastic alloy of nickel-titanium. 
     Surrounding core  20  is coil  30 . Coil over core wires are well known in the art and are described in detail in U.S. Pat. No. 5,147,317 to Shank which is incorporated by reference. Coil  30  may be made of a variety of metallic materials including super-elastic or linear-elastic materials such as Nitinol, radio-opaque materials such as gold or tungsten, precipitation hardenable alloys such as the non-ferrous cobalt-based alloys MP35N or Elgiloy™ and the ferrous alloys such as K91 from Sanvic Corp. and PH455 from Carpenter, or more conventional stainless steel alloys such as 304. Preferably coil  30  may be 0.001-0.015 inches in diameter, and made of 304 stainless steel. 
     Coil  30  is wrapped around substantially the entire length of core  20 . Preferably, coil  30  is not wrapped around the tapered distal portion  25  of core  20 . Coil  30  may be formed of flat ribbon ranging in dimensions 0.001-0.003 inches in thickness by 0.005 to 0.015 inches in width.  FIG. 4  illustrates coil  30 ′ having a rectangular cross-section. Coil  30  is wrapped in a helical fashion about core  20  by conventional winding techniques. The pitch of adjacent turns of coil  30  may be tightly wrapped so that each turn touches the succeeding turn or the pitch may be set such that coil  30  is wrapped about core  20  in an open fashion shown at  35 . Preferably, the pitch coil  30  is such that the coils are tightly wrapped over most of the proximal portion of core  20  with the pitch of each turn changing such that coil  30  has an open wrap shown at  35  near the distal end of core  20 . Varying the pitch of coil  30  allows guide wire  10  to have a more flexible distal segment. 
     Alternatively, coil  30  may be formed of cross-wound multifilar or multifilar single coil wire. Multifilar cross-wound coils are described in U.S. Pat. No. 4,932,419 to de Toledo which is herein incorporated by reference. As represented in  FIG. 3 , a cross-wound multifilar coil consists essentially of a first inner coil  44  of multiple coil wires wound in a first helical direction and a second outer coil  42  of multiple coil wires disposed about the first coil and wound in a second opposite helical direction. Coil over core wires tend to wind up and store energy when torqued rather than transmitting the torque. Multifilar coils provider less wind up and therefore lessen the potential for the distal tip of the wire to whip while the proximal end is being turned. 
     Bonding core  20  to coil  30  also improves the torque transmission of guide wire  10 . Coil  30  may be bonded to core  20  along the length of core  20  or in discrete sections. Bonding may be achieved in a variety of ways including using adhesives, brazing, welding, crimping, and swaging. Welding may be done through any of the techniques known in the art including spot welding using laser or resistance welding or ball welding using laser or plasma welding. Soldering may be done through any of the techniques known in the art and must include the step of preparing the surface of the Nitinol core  20  by plating or etching. Preferably the coil  30  will be bonded to the core  20  by laser spot welding thereby removing the need for preparing the surface of the core  20 . Laser spot welding is also advantageous because it may be done through coatings. 
     An alternative method of bonding the coil  30  to the core  20  is to provide a stainless steel hypotube (not shown) with an inner diameter dimensioned to closely fit about core  20 . The stainless steel hypotube may then be crimped onto core  20  and the coil  30  wound about the hypotube. The hypotube then provides a surface which is much easier to bound to a stainless steel coil  30  using conventional methods. Metal a foils or other materials may also be used as an intermediate which facilitates bonding between the coil  30  and the core  20 . 
     Yet another bonding method utilizes the polymer jacket  40  of the distal tip. The polymer may be applied in a manner that allows the polymer to flow between the coil and core. The polymer will provide a high integrity bond which will help to prevent the polymer jacket from separating from the coil  30  and bond the coil to core  20 . In addition to the these improvements, the polymer coating will make a better transition from the core  20  to the distal portion  25 . A tip bonded in this manor provides a further improvement by producing coloration differences between the coil wire and polymer. These differences act as stripes for the detection of guidewire advance in endoscopy application. 
     The distal portion  25  of core wire  20  may further include a polymer tip  40 . Polymer tip  40  serves several functions. Polymer tip  40  improves the flexibility of the distal portion  25  of core wire  20 . Choice of polymers for polymer tip  40  will vary the flexibility of the distal portion  25  of core wire  20 . For example, polymers with a low durometer or hardness will make a very flexible or floppy tip. Conversely, polymers with a high durometer will make a wire tip which is stiffer. 
     Polymer tip  40  also provides a more atraumatic tip for guide wire  10 . An atraumatic tip is better suited for passing through fragile body passages. Finally, polymer tip  40  may act as a binder for radio-opaque materials. Loading polymers with radio-opaque materials is well known in the art for producing a bright image under fluoroscopy and thereby allowing the user of guide wire  10  a better understanding of where the distal portion  25  of guide wire  10  is located within a patient&#39;s body. Suitable medical grade radio-opaque materials include tungsten, platinum, and iridium. 
     Suitable polymeric materials for polymer tip  40  include urethanes, elastomeric nylons such as Pebax, silicones, and co-polymers. Polymer tip  40  may be a single polymer, multiple layers, or a blend of polymers. 
     Coating (not shown) may also be done to the wire proximal to polymer tip  40 . Hydrophobic coatings such as fluoropolymers provide a dry lubricity which improves guide wire handling and device exchanges. A second lubricious polymer (not shown) may coat distal portion  25  of guide wire  10  or the entire wire  10 . Lubricious coatings improve steerability and improve lesion crossing capability. Suitable lubricious polymers are well known in the art and may include hydrophilic polymers. 
     Guide wire  10  may further include a colored coating. Colored guide wires are described in detail in U.S. Pat. No. 5,739,779 to Rowland which is herein incorporated by reference. In general, colored coatings may improve the visibility of the guide wire when it is being used in an endoscopic procedure. Striping may also be done. Striping allows the physician to gauge wire movement and position. Striping may be achieved by spray coating different colors on the wire  10 . Another way to stripe the wire  10  is to coat the wires of coil  30  prior to winding. 
       FIG. 2  depicts a second embodiment of the high performance coil wire where like elements are similarly numbered. All design advantages, materials of construction, and methods of manufacture are similar to those described above unless explicitly modified below. Guide wire  10  is comprised of a solid core  20  surrounded by a coil  30 . The distal portion  25  of core  20  may be tapered as described above or preferably is not tapered. Similar to the embodiment of  FIG. 1 , the distal portion  35  of coil  30  changes pitch to provide a softer less traumatic tip. 
     Guide wire  10  further includes a rounded tip  37 . Tip  37  may be polymeric or a metal tip welded to the distal portion  35  of coil  30 . Unlike common spring tipped guide wires, guide wire  10  does not have a safety ribbon connecting core  20  to tip  37 . Instead guide wire  10  may include a polymer  40  which may be flowed into the space between coils  35  and the space between the distal portion  25  and tip  37 . Suitable polymers are described above where choice of polymer may control the flexibility of the tip. Polymer  40  may also be loaded with radio-opaque materials. Finally, guide wire  10  may be coated as described above and may also include various colors or stripes. The distal portion of guide wire  10  is thereby provided with a very floppy tip which uses polymer  40  as a safety ribbon instead of a metallic safety ribbon. Guide wire  10  is provided with the advantage that core  20  does not need to be ground. 
     While the specification describes the preferred designs, materials, methods of manufacture and methods of use, those skilled in the art will appreciate the scope and spirit of the invention with reference to the following claims.