US20050119590A1 - Intravascular guide wire and method for manufacture thereof - Google Patents

Abstract

A guide wire, and a method for the manufacture thereof, having a core and a plastic jacket enclosing the core. The plastic jacket comprises a proximal portion formed of a first plastic material and a distal jacket portion formed of a second plastic material. The distal end of the proximal jacket portion and the proximal end of the distal jacket portion substantially abut each other and are of substantially equal outer diameters so as to form a smooth transition between the proximal and the distal jacket portions. According to another aspect, there is provided a guide wire with a selectively formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion with a hydrophilic coating and a proximal portion without a hydrophilic coating. According to another aspect, there is provided a guide wire having a formable metallic core and a plastic jacket encasing the formable core. The plastic jacket has a distal portion that is more radiopaque than a proximal portion.

Description

PRIORITY
• This is a continuation of U.S. patent application Ser. No. 09/991,573, filed Nov. 20, 2001; which is a continuation of U.S. patent application Ser. No. 08/881,586, filed Jun. 24, 1997, now U.S. Pat. No. 6,409,682; which is a continuation of U.S. patent application Ser. No. 08/534,113, filed Sep. 26, 1995, now abandoned; which is a continuation of U.S. patent application Ser. No. 08/319,772, filed Oct. 7, 1994, now U.S. Pat. No. 5,452,726; which is a continuation of 08/034,174, filed Mar. 12, 1993, now abandoned; which is a continuation of U.S. patent application Ser. No. 07/716,678, filed Jun. 18, 1991, now abandoned.
BACKGROUND OF THE INVENTION
• The present invention relates to intravascular guide wires, and methods of manufacture thereof. In particular, the present invention relates to an intravascular guide wire, and methods for the manufacture thereof, with improved properties to enhance the use thereof.
• Guide wires are used in various procedures in both the coronary regions and the peripheral regions of the body. Various sizes and lengths of guide wires are made to be suitable for various uses and locations in the body. For example, guide wires of a very small diameter, on the order of 0.010 to 0.018 inches may be suitable for use in narrow coronary vessels. Such guide wires may have an extremely floppy tip distal tip which may be bent or preformed by the physician to facilitate placement of the guide wire at the desired location. Other guide wires have larger diameter, for example 0.035 inches. These larger diameter guide wires may be especially useful in peripheral regions of the body. Larger diameter guide wires may be provided with very flexible tips or with relatively rigid tips depending upon the particular needs of the patient and the preferences of the physician. Guide wires come in a range of sizes in addition to those discussed above.
• Some of the characteristics preferred in guide wires by some physicians include strength, the ability to provide a track for a balloon or other device to advance over, and good torsional transmittance. A discussion of these and other preferred characteristics of guide wires is in Endovascular Surgery, by Moore, W. S. and Ahn, S. S; p. 157, W.B. Saunders Co. (1989). One of the characteristics considered desirable by some physicians in a guide wire is that it should be easy to grip and use manually at the proximal portion.
• Accordingly, it is an object of the present invention to provide a guide wire with favorable characteristics.
SUMMARY OF THE INVENTION
• According to a first aspect of the invention, there is provided a guide wire, and a method for the manufacture thereof, having a core and a plastic jacket enclosing the core. The plastic jacket comprises a proximal portion formed of a first plastic material and a distal jacket portion formed of a second plastic material. The distal end of the proximal jacket portion and the proximal end of the distal Jacket portion are of substantially equal outer diameters so as to form a smooth transition between the proximal and the distal jacket portions.
• According to another aspect of the invention, there is provided a guide wire, and a method for the manufacture thereof, with a core that is selectively formable in at least a distal portion thereof, and a plastic jacket encasing the selectively formable core. The plastic jacket has a distal portion with a hydrophilic coating and a proximal portion without a hydrophilic coating.
• According to another aspect of the invention, there is provided a guide wire, and a method for the manufacture thereof, having a core that is selectively formable, at least in a distal portion thereof, and a plastic jacket encasing the core. The plastic jacket has a distal portion that is more radiopaque than a proximal portion.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a sectional view of a first embodiment of the present invention.
• FIG. 2ashows a cross section of the embodiment ofFIG. 1 along line2a-2a′.
• FIG. 2bshows a cross section of the embodiment ofFIG. 1 along line2b-2b′.
• FIG. 2cshows a cross section of the embodiment ofFIG. 1 alongline2c-2c′.
• FIG. 3 is a sectional view of another embodiment of the present invention.
• FIG. 4 is a sectional view of yet another embodiment of the present invention.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
• Referring toFIG. 1 there is depicted a first preferred embodiment of the present invention. This embodiment is anintravascular guide wire10. Thisguide wire10 has adistal end12 and a proximal end14. Theguide wire10 may be approximately 180 centimeters in length and have an outside diameter of approximately 0.035 inches. Other lengths and diameters may be provided so that a range of sizes of guide wires may be available suitable for the different needs of various individual patients and the preferences of physicians. Such other sizes are contemplated within the scope of the present invention and of this embodiment in particular.
• Theguide wire10 includes acore18. The core may be made of a strong, yet flexible material, such as a metal, like stainless steel or nitinol, or other materials, or combinations thereof. In a preferred embodiment, thecore18 is made at least in part of a selectively formable metallic material, as explained in more detail below. Thecore18 extends from thedistal end12 to the proximal end14 of theguide wire10.
• In a preferred embodiment, thecore18 includes adistal portion20 and aproximal portion22. The proximal and distal portions are preferably formed of a single metallic wire. Thedistal portion20 has a smaller cross section than theproximal portion22 to impart greater flexibility to the distal end of the guide wire. In a preferred embodiment, thedistal portion20 of the guide wire comprises a series of stages or regions of tapered portions and portions of uniform cross section, as explained in more detail below. The series of stages of tapered portions and portions of uniform cross section are intended to impart increasing levels of flexibility to the guide wire toward the distal end.
• In this embodiment, theproximal portion22 of thecore18 has a diameter of approximately 0.018 inches.FIG. 2ashows a cross section of the guide wire in theproximal portion22. Theproximal portion22 of thecore18 extends from a proximal end of theguide wire10 to a proximal end of thedistal portion20 of thecore18. In this embodiment, thedistal portion20 of thecore18 is approximately 10.50 inches in length.
• Thedistal portion20 of the core includes afirst region24 immediately adjacent to and distal of theproximal portion22. Thisfirst region24 of thedistal portion20 of the core is approximately 2.0 inches in length. In thefirst region24, thecore18 tapers from the diameter of the proximal portion20 (e.g. 0.018 inches) to a diameter of approximately 0.009 inches. In thisfirst region24, the core has a circular cross section.
• Thedistal portion20 of the core next includes asecond region28 immediately adjacent to and distal of thefirst region24. Thissecond region28 of thedistal portion20 of the core is approximately 4.0 inches in length.FIG. 2bshows a cross section of the guide wire in this region. Thesecond region28 is a region of approximately uniform cross section. In thissecond region28, the core also preferably has a circular cross section.
• Thedistal portion20 of the core next includes athird region30 immediately adjacent to and distal of thesecond region28. Thisthird region30 of thedistal portion20 of the core is approximately 2.0 inches in length. In thethird region30, the core18 tapers from the diameter of the second region28 (e.g. 0.0090 inches) to a diameter of approximately 0.00525 inches. In thisthird region30, the core also has a circular cross section.
• Thedistal portion20 of the core next includes afourth region32 immediately adjacent to and distal of thethird region30. Thisfourth region32 of thedistal portion20 of the core is approximately 1.75 inches in length. In thefourth region32, thecore18 is flattened toward adistal end34 thereof to form a ribbon shape having dimensions of approximately 0.010 by 0.00225 inches.FIG. 2cshows a cross section of the guide wire in this region. The ribbon shape of this region causes the guide wire to tend to flex in one plane thereby facilitating the use thereof. In thefourth region32, the length of the distal flattened portion is approximately 0.5 inches, the length of the portion of circular cross section is approximately 0.7 inches, and a transition zone between these portions has a length of approximately 0.7 inches.
• Thedistal portion20 of the core wire, including the various regions of tapered and uniform cross section, may be formed by methods known in the art, such as chemical washes, polishes, grinding, or compressing.
• Theguide wire10 also includes aplastic jacket38 extending from the proximal end14 to thedistal end12. In a first preferred embodiment, theplastic jacket38 is formed of aproximal jacket portion40 and adistal jacket portion42. The outside diameter of theplastic jacket38 in this embodiment is approximately 0.035 inches although other diameters may be provided for guide wires of other dimensions.
• Thedistal jacket portion42 is approximately18 inches in length and extends proximally from the distal end of theguide wire10. The distal end of thedistal jacket portion42 extends over and covers the distal end of thecore wire18. Theproximal jacket portion40 extends from the proximal end of theguide wire10 distally. In this embodiment, the proximal end of thedistal jacket portion42 substantially abuts the distal end of theproximal jacket portion40. At the location at which the proximal and distal jacket portions abut, the outside diameters of the jacket portions are substantially the same and form a smooth transition at that location so that the guide wire can be readily inserted into and moved within a catheter or vessel or that a catheter or other device can be readily advanced over the guide wire.
• These two jacket portions are provided to yield features related to functions specifically associated with their respective locations. In this embodiment, theproximal jacket portion40 is made of a Teflon i.e. polyedrafluoroethylene material and thedistal jacket portion42 is made of polyurethane. Alternatively, theproximal jacket portion40 may be made of another material or combination of materials, such as flouroresins, such as Kynar (CH.sub.2 CF.sub.2), high density polyethylene, Delrin (polyacetal), Hytrel or polypropylene. Thedistal jacket portion42 may be made of other polymers or copolymers, or elastomers, or fluoroelastomers or silicone, Hytrel or nylon.
• In a preferred embodiment, the distal jacket portion has a hydrophilic coating applied to it to make the surface highly lubricious when it comes in contact with a fluid such as blood. The hydrophilic coating is believed to improve the biocompatability of the guide wire. This is based in part on observations that hydrophilic surfaces are generally less thrombogenic, and more specifically, tend to exhibit reduced platelet activation and aggregation compared to hydrophobic surfaces. In a preferred embodiment, the composition of the coating is a mixture of a hydrogel and a polyurethane in an organic/water solvent mixture. The solution mixture is applied to thedistal jacket portion42 and dried. In a preferred embodiment, polyvinyl pyrrolidone (PVP) is used as the hydrogel and commercial polyurethanes such as Dow (Pellethane 2363 Series) or Thermedics (the Tecophane or Tecoflex families) may be used. A polymer blend having an affinity to the polyurethane substrate of the distal jacket portion (via the urethane and the solution) is used while the other component is a slippery otherwise water-soluble material. The hydrogel will not tend to dissolve away because it is ensnared with the water insoluble polyurethane.
• As an alternative to using a hydrophilic coating, a different coating may be applied to the guide wire jacket to enhance its lubriciousness. Such a coating may be a silicone coating or other lubricious material.
• In a preferred embodiment, the hydrophilic coating is applied only to a distal portion of the guide wire, and in particular, only to thedistal jacket portion42. This is facilitated because the preferred hydrophilic coating is formulated to adhere to the urethane material of the distal jacket portion but not adhere to many different materials including the preferred material of the proximal jacket.
• As mentioned above, the proximal jacket portion is made of Teflon I.e, polytetrafluoroethylene which also provides a low friction surface though not as low friction as that of the distal jacket portion with the hydrophilic coating applied. It is advantageous for the proximal portion of the guide wire have a low friction surface in order to traverse a catheter lumen or a vessel. However, because the proximal portion of the guide wire will likely be in a portion of the vasculature not as tortuous as the distal portion, it would not require a surface of as high lubricity as the distal portion and therefore Teflon i.e., polytetrafluoroethylene is a good choice of materials.
• Moreover, this combination of low friction surfaces has the additional advantage that a very low friction surface, such as one having a hydrophilic coating, is used only on the distal portion of the guide wire. A very low friction surface, such as one having a hydrophilic coating, would be so slippery that it would be difficult for a physician to handle if it were on the proximal end as well. Accordingly, at the proximal end of the guide wire, this embodiment includes a surface that is easy for the physician who would be manipulating the guide wire from the proximal end to handle and yet is of sufficiently low friction so that it can readily traverse portions of the patient's vessels and provide good guide wire movement in a catheter.
• It is also preferred that the distal portion of the guide wire be provided with enhanced radiopaque properties. In the preferred embodiment, this is done by loading the material from which thedistal jacket42 is made with radiopaque materials such as barium, bismuth or tungsten. The loading of the distal jacket of polyurethane with a radiopaque material enhances the ability of a physician to observe the position of the distal end of the guide wire in the body of the patient by means of fluoroscopy.
• In a preferred embodiment, theproximal jacket portion40 of Teflon i.e., polytetrafluoroethylene is heat shrunk onto the core wire. Thedistal jacket portion42 is installed over the core wire by heating a sleeve of polyurethane to a temperature until it is reformed around the core wire. The proximal and distal jackets may be finished by a centerless grinding method so that the transition between the jacket portions is smooth.
• In a further embodiment, the guide wire has a core that is selectively formable at least in a distal portion thereof By a selectively formable core, it is meant that the wire from which the core is made may be bent to a particular shape and that the shape will be maintained by the wire. This allows the physician to impart a particular shape to the guide wire, by bending or kinking it for example, to facilitate its placement into a patient's vasculature. To provide this selective formability, in a preferred embodiment, the entire core wire may be made of stainless steel. Other materials may be used to provide this feature. The use of a formable material, such as stainless steel, provides advantages in the guide wire over materials that cannot be formed, such as superelastic materials like nitinol. Superelastic materials, like nitinol, are so resilient that they tend to spring back to their original shape even if bent, thus are not formable. Although superelastic material may be provided with a “preformed” memory shape, such a preformed shape is typically determined in the manufacture of the guide wire and cannot readily be altered or modified by the physician by simply bending the guide wire prior to use. Although use of superelastic materials such as nitinol in guide wire applications may provide some advantages in certain uses, a formable core, such as of stainless steel, which can be formed by the physician to a shape suitable for a particular patient or preferred by that physician, provides an advantage that cannot be obtained with a superelastic core guide wire.
• In a further preferred embodiment, the guide wire may include a core wire of a material having formable properties at a distal portion thereof and non-formable (e.g. superelastic properties) proximally. Such a construction would provide advantages in certain guide wire usages. A guide wire having these properties could be formed by using a superelastic material such as nitinol for the core wire and reducing its superelasticity in a distal portion thereof. This may be effected by heating the distal end of the superelastic core wire. Another means to reduce the superelastic properties of a distal end of the core wire would be to shape it mechanically, e.g. flattening it. Other methods of reducing the superelastic properties of the core wire may also be used. With a core wire having this dual combination of a formable distal portion and a superelastic proximal portion, desired shapes could be imparted by a physician to the distal end of the guide wire to facilitate making turns, etc., in tortuous vessel passages, while in the same guide wire the more proximal portion would possess superelastic properties to allow it to follow the distal portion through the tortuous passages without permanently deforming. This combination of formable and non-formable properties in the core wire may also be provided by using more than one material for the core wire or more than one wire.
• FIG. 3 shows another preferred embodiment of the present invention. This embodiment of the guide wire is similar in some respects to the embodiment of the guide wire, described above. Although this embodiment of the guide wire may be provided in large sizes (e.g. 0.035 inches), this embodiment is especially suitable for a guide wire of a smaller diameter, e.g. having an outer diameter of approximately 0.018 inches. If provided in a guide wire of smaller diameter, the diameter of the core wire and plastic jacket would be correspondingly smaller. Like the embodiment described above, this guide wire includes a core52 surrounded by aplastic jacket54. Thecore52 is preferably of a selectively formable material, as described above. In addition, in this embodiment, amarker56 is provided at a distal end58 of theguide wire50. Thismarker56 is located around the distal portion of thecore wire52 underneath theplastic jacket54. In this embodiment, themarker56 is a coil spring. Alternatively, the marker may be a ribbon, another wire, or any other similar component. Atip60 may be provided at the distal end of thecore wire52 to facilitate placement and connection of themarker56.
• Themarker56 may be made of platinum or stainless steel or other material. Themarker56 may be provided with radiopaque properties by selecting a material such as platinum. This may be in addition or as an alternative to providing radiopaque properties in the jacket portion through the use of loading with radiopaque materials. The use of a radiopaque marker may be preferred in smaller diameter guide wires where the plastic jacket, even if loaded with a radiopaque material, is of such a small size that it could be difficult to discern under fluoroscopy.
• FIG. 4 shows another preferred embodiment of the present invention. In the embodiment inFIG. 4, acore wire20 extends from a distal to a proximal end of the guide wire. As in the embodiment described above, thecore wire20 is surrounded by acore wire jacket38. In this embodiment, thecore wire jacket38 is comprised of a first jacket70. The first jacket70 of this embodiment is comprised of afirst portion72 and asecond portion74. Thecore wire jacket38 also includes asecond jacket76. Thesecond jacket76 covers the first jacket70 over thesecond portion74 thereof. Thesecond jacket76 may correspond to the proximal jacket of the previous embodiments. Thesecond jacket76 may be a thin tubing that is heat shrunk onto the first jacket70 over a proximal portion thereof. Alternatively, thesecond jacket76 may be applied by other methods, such as by spraying, dipping, etc.
• In a preferred embodiment, the outer diameter of thesecond jacket76 when it is in position surrounding the first jacket70 is approximately the same as the outer diameter of the first jacket70 in thefirst portion72 thereof at least in anarea80 of the guide wire where thesecond jacket76 ends so that the overall diameter of the guide wire through thisarea80 is substantially uniform. This uniformity may be further enhanced by polishing, grinding, or other means. To further provide for this uniformity in diameter, thesecond portion74 of the first jacket70 may be provided with a diameter that is less than that of thefirst portion72 of the first jacket70. This reduction in diameter may be formed by grinding, stretching, chemical erosion, or other means.
• In a preferred embodiment, thesecond jacket76 covers the proximal portion of the guide wire and an exposedfirst portion72 of the first jacket70 extends to a distal end of the guide wire. The first jacket70 andsecond jacket76 may be provided with properties specifically directed to their respective functions, as explained above in regard to the embodiment of the guide wire in which the jackets are in an abutting relationship. For example, the first jacket70 may be made of polyurethane and thesecond jacket76 may be made of a Teflon-like, i.e., polytetrafluoroethylene material. A hydrophilic coating may be applied to the first jacket70 in thefirst portion72 thereof to enhance lubricity, as explained above. If this embodiment of the guide wire is intended for use in peripheral regions of the body, it may have an outside diameter of approximately 0.035 inches. Other dimensions may be suitable as well for other size guide wires. As in the previously described embodiments, thecore20 may be a material such as stainless steel or nitinol and may have formable properties in at least a portion thereof.
• It is intended that the foregoing detailed description be regarded as illustrated rather than limiting and that it is understood that the following claims including all equivalents are intended to define the scope of the invention.

Claims (20)

1. A guidewire comprising:

an elongate core having a proximal region and a distal region, the distal region of the core having a proximal portion and a distal portion, the distal portion including a distal end, the distal portion comprising a flat ribbon;

an atraumatic tip positioned at the distal end of the elongate core;

a coil disposed over the distal portion of the core, the coil having a distal end positioned proximate the atraumatic tip, the coil extending proximally over the distal region of the elongate core.

2. The guidewire ofclaim 1, wherein the flat ribbon has a relatively flat cross-sectional shape.

3. The guidewire ofclaim 1, wherein the proximal portion of the core has a relatively round cross-sectional shape.

4. The guidewire ofclaim 1, wherein the distal region of the elongate core has a distally tapering diameter.

5. The guidewire ofclaim 1, wherein the proximal region of the elongate core includes a portion having a fluoroelastomer coating or jacket.

6. The guidewire ofclaim 1, wherein the proximal region of the elongate core includes a portion having a polytetrafluoroethylene coating or jacket.

7. The guidewire ofclaim 1, wherein the proximal region of the elongate core comprises stainless steel.

8. The guidewire ofclaim 1, wherein the elongate core comprises stainless steel.

9. The guidewire ofclaim 1, further comprising an outer sheath disposed over a portion of the distal region of the elongate core.

10. The guidewire ofclaim 1, wherein the coil comprises stainless steel.

11. The guidewire ofclaim 1, wherein the coil comprises platinum.

12. A method of manufacturing a guidewire, comprising steps of:

providing an elongate core having a proximal region and a distal region, the distal region of the core having a proximal portion and a distal portion, the distal portion including a distal end, the distal portion comprising a flat ribbon;

positioning an atraumatic tip at the distal end of the elongate core; and

disposing a coil over the distal portion of the core, the coil having a distal end positioned proximate the atraumatic tip, the coil extending proximally over the distal region of the elongate core.

13. The method ofclaim 12, further comprising providing a portion of the proximal region of the elongate core with a fluoroelastomer coating or jacket.

14. The method ofclaim 13, wherein the fluoroelastomer jacket or coating comprises a polytetrafluoroethylene coating or jacket.

15. The method ofclaim 13, wherein providing a fluoroelastomer coating or jacket comprises heat-shrinking a fluoroelastomer sheath over the elongate core.

16. The method ofclaim 13, wherein providing a fluoroelastomer coating or jacket comprises spraying or dipping the elongate core to form a fluoroelastomer coating.

17. The method ofclaim 12, wherein providing an elongate core comprises providing an elongate core with the proximal region of the elongate core comprising stainless steel.

18. The method ofclaim 12, wherein providing an elongate core comprises providing an elongate core comprising stainless steel.

19. The method ofclaim 12, wherein the coil comprises stainless steel.

20. The method ofclaim 12, wherein the coil comprises platinum.

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