Patent Application
20070213689
1. Field of the Invention
The present invention relates to a steerable infusion guidewire having improved torque characteristics, and more particularly to a bi-directional steerable infusion guidewire having a tip which may be very precisely “steered,” or deflected. The infusion guidewire is particularly suitable for use in conjunction with the insertion of a catheter into a vessel of the body, or alternatively, the infusion guidewire may be used by itself to open obstructions within a vessel or for infusing a therapeutic fluid 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.
Still further, when a guidewire is passed through or around an obstruction it may then be desirable to infuse a therapeutic fluid into the vessel at a location beyond the obstruction. Examples of fluids which have in the past been infused into blood vessels are Sirolimus (for treating unstable aneurysm) contrast media (to illuminate the lumen of a vessel with X-rays), chemotherapeutic liquids (treatment of cells).
While each of these guidewires have some degree of steerability, there is a need to have an infusion guidewire with very precise steering and a very small diameter which is suitable for the purposes described above. More particularly, there is an important need for a very small diameter infusion guidewire having improved torque characteristics which includes a distal tip which may be deflected very precisely in either of two directions to enhance steerability.
In accordance with one aspect of the present invention, there is provided a very small diameter steerable infusion 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. An infusion tube extends through the control passage of the device and extends from the proximal end of the device to a position which corresponds to the distal end of the elongated flexible tubing to create a passage for a therapeutic fluid to be infused through the device and then through spaces between the turns of the helical coil. Alternatively, the infusion tube may extend to the distal end of the device and pass through the distal rounded bead in order to infuse fluid through the distal tip of the device. With the enhanced rotational rigidity of the coil portion or the infusion guidewire, the entire infusion 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.
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 infusion guidewire in either an upward or downward direction.
A fluid infusion tube 20a extends from the proximal end of the infusion guidewire through the hypotube 16 to a position corresponding to the location where the helical coil 18 joins the elongated hypotube 16.
As may be appreciated, with this unitary construction of the deflection member 20 and the retaining ribbon 24, 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
Also, the deflection member 20 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 distal sections of the deflection member 20 and the retaining ribbon 24 are pre-shaped such that the distal tip of the infusion guidewire curves away from the longitudinal axis of the infusion guidewire in a direction toward that side of the infusion 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, the elongated member is preferably 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 infusion 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. Such laser cutting provides a coil with precise mating surfaces to assure proper interlocking between adjacent turns of the helical coil.
In the embodiment illustrated in
In operation, as previously described, the distal tip of the steerable infusion guidewire 12 is normally biased into a downwardly curved position as illustrated in
Since the deflection member 20 and the retaining ribbon 24 are pre-shaped prior to any activation of the steerable infusion guidewire, the amount of force required to deflect the infusion guidewire in this direction is very small thereby preventing buckling of the deflection member 20 as it is pushed distally. As the deflection member 20 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 infusion guidewire.
When the slidable control knob 26 is moved in a proximal direction as shown in
In the embodiment of the device illustrated in
As previously discussed, when the proximal end of the infusion guidewire 12 is rotated by a physician to “steer” the distal end of the infusion 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 infusion guidewire.
In a preferred embodiment of the present invention, the elongated deflection member 20 and the retaining ribbon 24 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 infusion 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 distal section of the deflection member 20 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 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 on its distal end to act as a sealant preventing the entry of blood and contrast media into the infusion guidewire and a fluorinated polymer 39, such as Teflon, on its proximal end for lubrication purposes.
It may be seen that the infusion 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 infusion guidewire through the vessels of the body. As may be apparent, the disclosed infusion 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 infusion 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.
This patent application is a continuation-in-part of U.S. patent application Ser. No. 10/691,823 (Attorney Docket No. CRD1061USACIP1), filed on Oct. 23, 2003, entitled, “Guidewire With Deflectable Tip Having Improved Torque Characteristics,” which is a continuation-in-part of U.S. patent application Ser. No. 10/224,168 (Attorney Docket No. CRD1061USNP), filed on Aug. 20, 2002, entitled, “Guidewire With Deflectable Tip,” now issued as U.S. Pat. No. 7,128,718, which is a nonprovisional patent application of U.S. patent application Ser. No. 60/366,739 (Attorney Docket No. CRD1035USPSP), filed on Mar. 22, 2002, entitled, “Deflection Wire Concept.”
| Number | Date | Country | |
|---|---|---|---|
| 60366739 | Mar 2002 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10691823 | Oct 2003 | US |
| Child | 11590536 | Oct 2006 | US |
| Parent | 10224168 | Aug 2002 | US |
| Child | 10691823 | Oct 2003 | US |
