Abstract:
A bi-directional steerable guidewire having a deflectable distal tip which comprises a longitudinal hypotube and an interlocking spring coil attached to the distal end of the hypotube and also includes a longitudinally movable deflection member which is attached to the distal end of the spring coil and a tip retaining member which extends from the distal end of the hypotube to the distal end of the spring coil for providing very precise deflection of the distal tip.

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This patent application is a continuation-in-part of U.S. patent application Ser. No. 10/224,168, filed on Aug. 20, 2002, now U.S. Pat. No. 7,128,718 entitled, “Guidewire With Deflectable Tip,” which is a nonprovisional patent application of U.S. patent application Ser. No. 60/366,739, filed on Mar. 22, 2002, entitled, “Deflection Wire Concept.” 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a steerable guidewire having improved torque characteristics, and more particularly to a bi-directional steerable guidewire having a tip which may be very precisely “steered,” and deflected. The guidewire is particularly suitable for use in conjunction with the insertion of a catheter into a vessel of the body, or alternatively, the guidewire may be used by itself to open obstructions within a vessel or to carry a therapeutic device for removing obstructions within a vessel. 
     2. Description of the Prior Art 
     For many years guidewires have included a core wire with the distal end being tapered and with a coil spring mounted on the tapered distal end. These guidewires have been used to facilitate the insertion of a catheter into a vessel of the body. Generally, the guidewire is inserted into a vessel, a catheter is inserted over the guidewire and the catheter is then moved through the vessel until the distal end of the catheter is positioned at a desired location. The guidewire is then retracted from the catheter and the catheter is left in the vessel. Alternatively, the guidewire may be first inserted into the catheter with the distal portion of the guidewire extending beyond the distal end of the catheter. This assembly is then inserted into a vessel with the distal tip of the guidewire being used to facilitate movement of the guidewire and catheter through the vessel. Again, when the distal tip of the catheter has been placed in a desired location, the guidewire may be retracted thereby leaving the catheter in place within the vessel. 
     Another common application for guidewires is that of using the distal tip of the guidewire for removing an obstruction within a vessel. Often times this procedure is accomplished by inserting the guidewire within a vessel, moving the distal tip of the guidewire into contact with the obstruction and then very gently tapping the distal tip of the guidewire against the obstruction until the guidewire passes through the obstruction. Alternatively, various types of devices may be placed on the distal end of a guidewire for actively opening an obstruction within the vessel. Examples of such devices which may be placed on the end of the guidewires in order to open an obstruction are disclosed in the following Robert C. Stevens U.S. Pat. Nos. 5,116,350; 5,078,722; 4,936,845; 4,923,462; and, 4,854,325. 
     While most guidewires used today do not include a mechanism for deflecting or steering the tip of the guidewire, it is very desirable to provide tip steering in order to facilitate movement of the guidewire through the tortuous vessels of the body. There are many patents directed toward different mechanisms for deflecting the distal tip of a guidewire in order to steer the guidewire. Examples of such guidewires are disclosed in the following patents: U.S. Pat. No. 4,815,478 to Maurice Buchbinder, et al., U.S. Pat. No. 4,813,434 to Maurice Buchbinder, et al., U.S. Pat. No. 5,037,391 to Julius G. Hammerslag, et al., U.S. Pat. No. 5,203,772 to Gary R. Hammerslag, et al., U.S. Pat. No. 6,146,338 to Kenneth C. Gardeski, et al., U.S. Pat. No. 6,126,649 to Robert A. VanTassel, et al., U.S. Pat. No. 6,059,739 to James C. Baumann and U.S. Pat. No. 5,372,587 to Julius G. Hammerslag, et al. U.S. Pat. No. 4,940,062 to Hilary J. Hampton, et al., discloses a balloon catheter having a steerable tip section. All of the above-identified patents are incorporated herein by reference. 
     While each of the latter group of patents disclose guidewires having some degree of steerability, there is a need to have a guidewire with very precise steering in a guidewire of a very small diameter which is suitable for the purposes described above. More particularly, there is an important need for a very small diameter guidewire having improved torque characteristics which includes a distal tip which may be deflected very precisely in either of two directions to enhance steerability. 
     SUMMARY OF THE INVENTION 
     In accordance with one aspect of the present invention, there is provided a very small diameter steerable guidewire having a deflectable tip which includes an elongated flexible tubing, a flexible helical coil attached to the distal portion of the flexible tubing, an elongated deflection member which is slidably disposed within the tubing and within the helical coil. The flexible helical coil is formed from an elongated member having a rectangular, or square cross section, and having continuous undulations wherein the undulations of adjacent turns interlock with each other, i.e., peak undulation of one turn interlocking with valley undulation of adjacent turn, to thereby enhance the rotational rigidity, referred to as torque characteristic, of the coil. The proximal portion of the deflection member is of a cylindrical configuration and the distal portion is tapered to form a deflection ribbon. Alternatively, the deflection member may take the form of a proximal cylindrical wire which is attached at its distal end to a deflection ribbon. In addition, a retaining ribbon is attached to the distal end of the flexible tubing and is oriented to extend in a plane which is generally parallel to the plane of the ribbon portion of the deflection member. An attachment member which may take the form of a rounded bead, preferably formed from epoxy, is bonded to the distal end of the helical coil, the distal end of the deflection ribbon and the distal end of the retaining ribbon so that longitudinal movement of the deflection member causes the distal end of the helical coil to be deflected. With the enhanced rotational rigidity of the coil portion or the guidewire, the entire guidewire has enhanced rotational rigidity. 
     In accordance with another aspect of the present invention, the continuous undulations take the form of a sinusoidal wave, or alternatively a square sinusoidal wave, having positive and negative peaks and in which the positive peaks of adjacent turns of coils engage negative peaks, or valleys, of adjacent turns. 
     In accordance with another aspect of the present invention, the retaining ribbon and the deflection ribbon are preferably pre-shaped into a curved configuration to thereby cause the flexible helical coil to be biased into a normally curved shape. 
     In accordance with a further aspect of the present invention, the distal portion of the deflection ribbon engages the attachment member, or rounded bead, at a location offset from the center of the attachment member, and the distal portion of the retaining ribbon engages the attachment member at a location offset from the center of the attachment member. Preferably, the retaining ribbon engages the attachment member at a location offset from the center portion of the attachment member in the opposite direction from the offset location of the deflection ribbon. 
     In accordance with still another aspect of the present invention, the deflection ribbon and the retaining ribbon are connected to each other within the attachment member. Preferably these two elements are formed as a single unitary element. In a preferred embodiment of the invention the cylindrical deflection member is flattened to form the deflection ribbon and is further flattened at its distal end to form the retaining ribbon. The retaining ribbon is bent 180 degrees with respect to the deflection ribbon to form a generally U-shaped bend to thereby establish a predetermined spacing between the ribbons and to also cause these ribbons to remain parallel to each other. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an enlarged elevational view of a balloon on a guidewire having a deflectable tip and control handle in accordance with the one aspect of the present invention; 
         FIGS. 2 and 2A  are enlarged elevational sectional views showing the distal end of the balloon on a guidewire in its normal pre-shaped position; 
         FIG. 3  is an enlarged sectional view showing the distal end of the steerable guidewire of  FIG. 2  rotated 180 degrees; and, 
         FIGS. 4 and 5  are sectional views showing the steerable guidewire deflected from its normal position to opposite extremes of deflection. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       FIG. 1  generally illustrates a steerable guidewire system  10  which embodies the present invention and comprises a steerable guidewire  12  coupled to a control handle  14 . More particularly, the steerable guidewire comprises an elongated hypotube  16 , a helical coil  18  attached to and extending from the distal end of the hypotube  16 . The helical coil  18  is of a rectangular or square cross-sectional configuration and is preferably formed from platinum tungsten with the proximal turns being wound such that adjacent turns of the proximal portion are in contact, or loosely interlocked with each other. 
     While the preferred embodiment of the present invention includes the helical coil  18 , this element may take the form of any flexible rectangular or square cross-sectional member, such as for example a thin square metallic tube with or without portions of the tube removed, for example laser cutting, so as to form a very flexible cylindrical or square member. An elongated deflection member  20  extends from the proximal end of the control handle through the hypotube  16  and through the helical coil  18 , and is connected into an attachment member, or rounded bead  22 , which is disposed at the distal tip of the helical coil  18 . In addition, a retaining ribbon  24  is connected to the distal end of the hypotube  16  and is also connected to the rounded bead  22 . 
     The control handle  14  generally comprises a slidable control knob  26  which may be moved longitudinally with respect to the control handle. The control handle  14  is coupled to the deflection member  20 . As will be discussed in more detail, the longitudinal movement of the slidable control knob  26  causes deflection of the distal tip of the guidewire in either an upward or downward direction. 
       FIGS. 2 ,  2 A and  3  illustrate in more detail the distal portion of the steerable guidewire  12 . As may be appreciated,  FIG. 3  is a view of the guidewire  12  shown in  FIG. 2  with the guidewire being rotated 90 degrees about its longitudinal axis. More particularly, the proximal end of the helical coil  18  is bonded, preferably by use of an epoxy, to the outer surface near the distal end of the hypotube  16 . The elongated deflection member  20  takes the form of a small diameter cylindrical deflection member  20  having an intermediate portion which is flattened to form a thin deflection ribbon  34  having a thickness of approximately 0.002 inches. The distal end of the cylindrical deflection member  20  is further flattened to a thickness of approximately 0.0015 inches and is bent back 180 degrees to form a U-shaped bend  26   a  between the deflection ribbon  34  and the retaining ribbon  24 . The proximal end of the retaining ribbon  24  is bonded, preferably by use of epoxy, to the outer surface of the distal end of the hypotube  16 . The retaining ribbon  24  is aligned in a plane parallel to the plane of the deflection ribbon  34  and the U-shaped portion between the ribbons is encapsulated by the attachment member which preferably takes the form of a rounded epoxy bead  22  bonded to the distal tip of the helical coil  18 . 
     As may be appreciated, with this unitary construction of the ribbon members, these members remain aligned so that both lie in planes parallel to each other. In addition, the U-shaped bend portion when encapsulated into the rounded bead  22  causes the retaining ribbon and deflection ribbon to be properly spaced with respect to each other. 
     As illustrated in  FIG. 2 , the retaining ribbon  24  is preferably attached to the rounded bead  22  at a position offset from the center of the bead in the same direction that the retaining ribbon  24  is offset from the longitudinal axis of the steerable guidewire  12 . In addition, the deflection ribbon  34  is attached to the bead at a position offset from the center of the bead in an opposite direction from the offset of the retaining ribbon  24 . 
     Also, as may be seen in  FIG. 2 , the deflection ribbon  34  and the retaining ribbon  24  are pre-shaped into an arcuate, or curved, configuration to thereby maintain the helical coil  18  in a normally curved configuration. The ribbons  24 ,  34  are pre-shaped such that the distal tip of the guidewire curves away from the longitudinal axis of the guidewire in a direction toward that side of the guidewire containing the retaining ribbon  24 . 
     The helical coil  18  is formed as an elongated member having a rectangular, or square, cross-sectional configuration and wound in a helical configuration. In addition as illustrated in  FIG. 2A , the elongated member is formed with re-occurring steps, or step undulations, which when wound into a helical configuration so that adjacent turns to loosely interlock thereby preventing movement between adjacent turns. Such interlocking turns enhance the rotational rigidity or “torqueability” of the coil such that when the proximal end of the coil is rotated 180 degrees, the distal end of the coil will rotate approximately 180 degrees. Accordingly, the distal end of the coil more nearly tracks, rotationally, the proximal end of the coil thereby significantly improving the “tortional” characteristics of the coil. By improving the “tortional” characteristics of the coil, the overall “tortional” characteristics of the guidewire are significantly improved. 
     As opposed to winding an elongated member to form the helical coil  18 , a preferred method of forming the helical coil is by laser cutting the coil from a single thin-walled tube of an alloy in the undulations locking, stepped configuration as illustrated in  FIG. 2A . Such laser cutting provides a coil with precise mating surfaces to assure proper interlocking between adjacent turns of the helical coil. 
     In operation, as previously described, the distal tip of the steerable guidewire  12  is normally biased into a downwardly curved position as illustrated in  FIG. 2  because of the curve of the pre-shaped deflection ribbon  34  and the retaining ribbon  24 . When the slidable control knob  26  is moved distally as shown in  FIG. 5 , the deflection member  20  will be moved distally thereby causing the deflection ribbon  34  to move in a distal direction. As the deflection ribbon is moved distally, a pushing force is applied to the top portion of the rounded bead  22 . The retaining ribbon  24  is attached to the lower portion of the bead  22  to thereby maintain the bead at a fixed distance from the distal end of the hypotube  16 . As the deflection ribbon  34  is moved to the right, the tip of the guidewire is caused to deflect downwardly to a maximum deflected position. 
     Since the deflection ribbon  34  and the retaining ribbon  24  are pre-shaped prior to any activation of the steerable guidewire, the amount of force required to deflect the guidewire in this direction is very small thereby preventing buckling of the deflection ribbon  34  as the deflection ribbon is pushed distally. As the deflection ribbon  34  is moved distally, the upper turns of the helical coil become slightly stretched and the lower turns of the coil become slightly compressed. The deflection member  20  has a diameter of about 0.0065 inches and the deflection ribbon has a thickness of about 0.002 inches to thereby provide sufficient stiffness to prevent the buckling of these elements when the deflection member  20  is pushed distally. This construction also provides sufficient stiffness to transmit the necessary force from the proximal end to the distal end of the guidewire. 
     When the slidable control knob  26  is moved in a proximal direction as shown in  FIG. 4 , the deflection member  20  will be pulled to the left to thereby cause the deflection ribbon  34  to pull on the top portion of the bead  22 . Since again the retaining ribbon  24  causes the lower portion of the bead to remain at a fixed distance from the distal end of the hypotube  16 , the tip of the guidewire  12  is caused to bend in an upward direction to a maximum deflection as shown in  FIG. 4 . Since the deflection ribbon  34  is in tension when the deflection member  20  is pulled, there is no concern for buckling of the deflection ribbon  34 . As the deflection ribbon  34  is moved proximally, the upper coil turns become slightly compressed and the lower coil turns become somewhat stretched. 
     As previously discussed, when the proximal end of the guidewire  12  is rotated by a physician to “steer” the distal end of the guidewire, with the interlocking turns of adjacent coils of the helical coil  18 , the distal tip will rotate on a one-to-one basis with respect to the proximal end of the hypotube  16 . In other words, there is no “play” or “lag” between rotation of the proximal end and the distal end of the guidewire. 
     In a preferred embodiment of the present invention, the elongated deflection member  20 , retaining ribbon  24  and deflection ribbon  34  are constructed of nitinol, but these elements may be formed from other flexible materials including polymers. The helical coil  18  preferably formed by laser cutting as previously discussed, is constructed from an alloy comprised of about 92 percent platinum and 8 percent tungsten, but this element may also be constructed from numerous other materials. It is desirable that the coil exhibit the characteristic of being radiopaque to X-rays to assist in the positioning of the distal tip of the steerable guidewire  12 . The deflection member  20  is formed from a single cylindrical nitinol wire of about 0.0065 inches in diameter having an intermediate portion which is flattened to form the deflection ribbon  34  with a thickness of about 0.002 inches, and a distal portion which is flattened to form the retaining ribbon  24  with a thickness of about 0.0015 inches. The retaining ribbon  24  is bent back 180 degrees to form a generally U-shaped bend, which is subsequently encapsulated within the rounded bead  22 . The rounded bead  22  is preferably formed with epoxy, but may be formed with soldering or by welding. 
     It has been found that the addition of graphite between the deflection member  20  and deflection ribbon  34 , and the inner lumen of the hypotube  16  provides lubrication. Other lubricants, such as Teflon or MDX may be used for this purpose. The helical coil  18  is preferably coated with an elastomeric polymer  41  on its distal end to act as a sealant preventing the entry of blood and contrast media into the guidewire and a fluorinated polymer  39 , such as Teflon, on its proximal end for lubrication purposes. 
     It may be seen that the guidewire as disclosed may be very easily and very precisely rotated and then deflected in either of two directions for very precise steering of the guidewire through the vessels of the body. As may be apparent, the disclosed guidewire may be used for placement of a catheter within the vasculature of the human body, it may be used by itself to cross an obstruction within the vessels or it may be used to carry a therapeutic device mounted on the distal end of the guidewire for purposes of removing obstructions which may exist within a vessel of the body. 
     The preceding specific embodiment is illustrated of the practice of this invention. It is to be understood, however, that other variations may also be employed without departing from the spirit and scope of the invention as hereinafter claimed.