VARIABLE STIFFNESS GUIDEWIRE

Abstract

The core element for a guidewire comprises a proximal stainless steel portion and a distal nitinol portion. The distal nitinol portion comprises a proximal segment of an at least partially linear elastic nitinol and a distal segment of a super elastic nitinol. The proximal end of a first spring coil contacts the super elastic nitinol with the first spring coil distal end being proximal the distal end of the distal segment of the super elastic nitinol. A second spring coil has a proximal portion that contacts the first spring coil distal end at a spring coil connection. Further, the second spring coil extends distally to an atraumatic tip. Extending radially from a longitudinal axis of the core wire, the first and second spring coils are spaced from and circumferentially unsupported by the distal nitinol core portion at the spring coil connection.

Claims

1. A variable stiffness guidewire, comprising: a) a core element extending along a longitudinal axis, the core element comprising a first sidewall of a first diameter extending distally to a tapered section meeting a second sidewall of a second diameter, the second diameter being less than the first diameter; and b) a distal atraumatic tip; c) a first spring coil extending from a first spring coil proximal portion to a first spring coil distal end, wherein the first spring coil proximal portion contacts at least the first sidewall of the first diameter of the core element, and wherein the first spring coil distal end is proximal the distal end of the core element; and d) a second spring coil extending from a second spring coil proximal portion to a second spring coil distal end, wherein the second spring coil proximal portion contacts the first spring coil distal end at a spring coil connection, and wherein the second spring coil extends distally beyond the distal end of the core element with the second spring coil distal end connected to the distal atraumatic tip, e) wherein extending radially from the longitudinal axis of the core wire to the spring coil connection, the first and second spring coils are spaced from and circumferentially unsupported by the distal core portion at the spring coil connection.

2. The guidewire of claim 1 wherein a proximal core portion of the core element comprises stainless steel and a distal portion of the core element comprises nitinol.

3. The guidewire of claim 1 wherein the second spring coil proximal portion either overlaps or is interwoven with the first spring coil.

4. The guidewire of claim 1 wherein a non-super elastic shaping ribbon is attached to the core element, and wherein the shaping ribbon is disposed inside at least the second spring coil and extends distally beyond the distal end of the core element to connect to the distal atraumatic tip.

5. The guidewire of claim 1 wherein the first spring coil is of a non-radiopaque material and the second spring coil is of a radiopaque material.

6. A variable stiffness guidewire, comprising: a) a core element extending along a longitudinal axis, the core element comprising a first sidewall of a first diameter extending distally to a tapered section meeting a second sidewall of a second diameter, the second diameter being less than the first diameter; and b) a distal atraumatic tip; c) a first spring coil extending from a first spring coil proximal portion to a first spring coil distal end, wherein the first spring coil proximal portion contacts at least the first sidewall of the first diameter of the core element, and wherein the first spring coil distal end is proximal the distal end of the core element; and d) a second spring coil extending from a second spring coil proximal portion to a second spring coil distal end, wherein the second spring coil proximal portion contacts the first spring coil distal end at a spring coil connection, and wherein the second spring coil distal end and the distal end of the core element both connect to the distal atraumatic tip, e) wherein, extending radially from the longitudinal axis of the core wire to the spring coil connection, the first and second spring coils are spaced from and circumferentially unsupported by the distal core portion at the spring coil connection.

7. The guidewire of claim 6 wherein a non-super elastic shaping ribbon is attached to the core element, and wherein the shaping ribbon is disposed inside at least the second spring coil and is connected to the distal atraumatic tip.

8. A variable stiffness guidewire, comprising: a) a core element comprising a proximal core portion and a distal nitinol core portion, wherein the distal nitinol core portion comprises: i) a proximal segment of an at least partially linear elastic nitinol; and ii) a distal segment of a super elastic nitinol extending to a distal end thereof, iii) wherein the distal segment of the super elastic nitinol has at least a first sidewall of a first diameter extending distally to a tapered section meeting a second sidewall of a second diameter, the second diameter being less than the first diameter; and b) a distal atraumatic tip; c) a first spring coil extending from a first spring coil proximal portion to a first spring coil distal end, wherein the first spring coil proximal portion contacts at least the first sidewall of the first diameter of the distal segment of the super elastic nitinol, and wherein the first spring coil distal end is proximal the distal end of the distal segment of the super elastic nitinol; and d) a second spring coil extending from a second spring coil proximal portion to a second spring coil distal end, wherein the second spring coil proximal portion contacts the first spring coil distal end, and wherein the second spring coil extends distally beyond the distal end of the distal segment of the super elastic nitinol of the core element with the second spring coil distal end connected to the distal atraumatic tip, e) wherein, extending radially from the longitudinal axis of the core wire to the spring coil connection, the first and second spring coils are spaced from and circumferentially unsupported by the distal nitinol core portion at the spring coil connection.

9. The guidewire according to claim 6 wherein the proximal core portion of the core element comprises stainless steel.

10. The guidewire according to claim 6 wherein the second spring coil proximal portion either overlaps or is interwoven with the first spring coil.

11. The guidewire according to claim 8 wherein a non-super elastic shaping ribbon is attached to the distal segment of the super elastic nitinol of the core element, and wherein the shaping ribbon is disposed inside at least the second spring coil and extends distally beyond the distal end of the distal segment of the super elastic nitinol to connect to the distal atraumatic tip.

12. The guidewire according to claim 8 wherein the first spring coil is of a non-radiopaque material and the second spring coil is of a radiopaque material.

13. The guidewire according to claim 8 wherein the second spring coil comprises platinum.

14. The guidewire according to claim 8 wherein the distal nitinol core portion of the core element has a composition in the range of from about 54 atomic % nickel: about 46 atomic % titanium to about 57 atomic % nickel: about 43 atomic % titanium.

15. A variable stiffness guidewire, comprising: a) a core element comprising a proximal stainless steel core portion and a distal nitinol core portion, wherein the distal nitinol core portion comprises: i) a proximal segment of an at least partially linear elastic nitinol; and ii) a distal segment of a super elastic nitinol extending to a distal end thereof, iii) wherein the distal segment of the super elastic nitinol has at least a first sidewall of a first diameter extending distally for a first length to a tapered section meeting a second sidewall of a second diameter extending for a second length, the second diameter being less than the first diameter and the second length being less than the first length; b) a distal atraumatic tip; c) a first spring coil extending from a first spring coil proximal portion to a first spring coil distal end, wherein the first spring coil proximal portion contacts at least a portion of the first length of the first sidewall of the first diameter of the distal segment of the super elastic nitinol, and wherein the first spring coil distal end is proximal the distal end of the distal segment of the super elastic nitinol; and d) a second spring coil extending from a second spring coil proximal portion to a second spring coil distal end, wherein the second spring coil proximal portion contacts the first spring coil distal end, and wherein the second spring coil extends distally beyond the second length of the second sidewall of the distal segment of the super elastic nitinol of the core element with the second spring coil distal end connected to the distal atraumatic tip, e) wherein, extending radially from the longitudinal axis of the core wire to the spring coil connection, the first and second spring coils are spaced from and circumferentially unsupported by the distal nitinol core portion at the spring coil connection.

16. The guidewire according to claim 15 wherein the core element terminates proximally with respect to the atraumatic tip.

17. The guidewire according to claim 15 further comprising a non-super elastic shaping ribbon attached to the distal segment of the super elastic nitinol of the core element, wherein the shaping ribbon is disposed inside at least the second spring coil and extends distally beyond the distal end of the distal segment of the super elastic nitinol of the core element to connect to the distal atraumatic tip.

18. The guidewire according to claim 17 wherein the shaping ribbon comprises stainless steel.

19. The guidewire according to claim 15 wherein the first spring coil is of a non-radiopaque material and the second spring coil is of a radiopaque material, and wherein the respective first and second non-radiopaque and radiopaque spring coils either overlap or are interwound with each other.

20. The guidewire according to claim 15 wherein the second spring coil comprises a distal marker coil.

21. The guidewire according to claim 15 wherein the distal nitinol core portion of the core element has a composition in the range of from about 54 atomic % nickel: about 46 atomic % titanium to about 57 atomic % nickel: about 43 atomic % titanium.

22. A variable stiffness guidewire, comprising: a) a core element comprising a proximal core portion and a distal nitinol core portion, wherein the distal nitinol core portion comprises: i) a proximal segment of an at least partially linear elastic nitinol; and ii) a distal segment of a super elastic nitinol extending to a distal end thereof, iii) wherein the distal segment of the super elastic nitinol has at least a first sidewall of a first diameter extending distally for a first length to a tapered section meeting a second sidewall of a second diameter extending for a second length, the second diameter being less than the first diameter and the second length being less than the first length; b) a coupler connecting the proximal core portion to the proximal segment of the linear elastic nitinol; and c) a distal atraumatic tip; d) a first spring coil extending from a first spring coil proximal portion to a first spring coil distal end, wherein the first spring coil proximal portion contacts at least a portion of the first length of the first sidewall of the first diameter of the distal segment of the super elastic nitinol, and wherein the first spring coil distal end is proximal the distal end of the distal segment of the super elastic nitinol; and e) a second spring coil extending from a second spring coil proximal portion to a second spring coil distal end, wherein the second spring coil proximal portion contacts the first spring coil distal end, and wherein the second spring coil extends distally beyond the distal end of the distal segment of the super elastic nitinol of the core element with the second spring coil distal end connected to the distal atraumatic tip, f) wherein, extending radially from the longitudinal axis of the core wire to the spring coil connection, the first and second spring coils are spaced from and circumferentially unsupported by the distal nitinol core portion at the spring coil connection.

23. The guidewire according to claim 22 wherein the proximal core portion of the core element comprises a non-super elastic alloy.

24. The guidewire according to claim 22 wherein the first spring coil is of a non-radiopaque material and the second spring coil is of a radiopaque material, and wherein the respective first and second non-radiopaque and radiopaque spring coils either overlap or are interwound with each other.

25. The guidewire according to claim 22 wherein the distal nitinol core portion of the core element has a composition in the range of from about 54 atomic % nickel: about 46 atomic % titanium to about 57 atomic % nickel: about 43 atomic % titanium.

26. A variable stiffness guidewire, comprising: a) a core element comprising a proximal core portion and a distal nitinol core portion, wherein the distal nitinol core portion comprises: i) a proximal segment of an at least partially linear elastic nitinol; and ii) a distal segment of a super elastic nitinol extending to a distal end thereof, iii) wherein the distal segment of the super elastic nitinol has at least a first sidewall of a first diameter extending distally to a tapered section meeting a second sidewall of a second diameter, the second diameter being less than the first diameter; and b) a distal atraumatic tip; c) a first spring coil extending from a first spring coil proximal portion to a first spring coil distal end, wherein the first spring coil proximal portion contacts at least the first sidewall of the first diameter of the distal segment of the super elastic nitinol, and wherein the first spring coil distal end is proximal the distal end of the distal segment of the super elastic nitinol; and d) a second spring coil extending from a second spring coil proximal portion to a second spring coil distal end, wherein the second spring coil proximal portion contacts the first spring coil distal end, and wherein the second spring coil distal end and the distal end of the distal segment of the super elastic nitinol of the core element both connect to the distal atraumatic tip, e) wherein, extending radially from the longitudinal axis of the core wire to the spring coil connection, the first and second spring coils are spaced from and circumferentially unsupported by the distal nitinol core portion at the spring coil connection.

27. The guidewire according to claim 26 wherein a non-super elastic shaping ribbon is attached to the distal segment of the super elastic nitinol of the core element, and wherein the shaping ribbon is disposed inside at least the second spring coil and is connected to the distal atraumatic tip.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 where shown, in section, a finger-formable version of the present invention in which the superelastic distal segment of the core wire or core element extends distally from before the first taper (shown by shading) all the way to the end of the core wire, which terminates short of the extreme distal tip.

[0014] FIG. 1A is an enlarged view of the indicated area in FIG. 1 showing that extending radially from the longitudinal axis of the core wire to a connection between first and second spring coils, the spring coils are spaced from and circumferentially unsupported by the distal core portion at the spring coil connection.

[0015] FIG. 2 is an embodiment of the present invention in which the superelastic distal portion begins adjacent to the first core wire taper (shown by shading) and extends to the end of the core wire, which also terminates short of the guidewire distal tip.

[0016] FIG. 2A is an enlarged view of the indicated area in FIG. 2 showing that extending radially from the longitudinal axis of the core wire to a connection between first and second spring coils, the spring coils are spaced from and circumferentially unsupported by the distal core portion at the spring coil connection.

[0017] FIG. 3 is an embodiment to the present invention in which the superelastic core wire segment begins distal to the first core wire taper (shown by shading) and extends to the end of the core wire which also terminates short of the guidewire extreme distal tip.

[0018] FIG. 3A is an enlarged view of the indicated area in FIG. 3 showing that extending radially from the longitudinal axis of the core wire to a connection between first and second spring coils, the spring coils are spaced from and circumferentially unsupported by the distal core portion at the spring coil connection.

[0019] FIGS. 4 to 6 are non-tip formable embodiments of the present invention in which the zones of superelastic core wire begin at the same points as shown in FIGS. 1 to 3, respectively, and the core wire or core element extends all the way to the guidewire tip.

[0020] FIGS. 4A to 6A are enlarged views of the indicated areas in FIGS. 4 to 6 showing that extending radially from the longitudinal axis of the core wire to a connection between first and second spring coils, the spring coils are spaced from and circumferentially unsupported by the distal core portion at the spring coil connection.

[0021] FIG. 7 shows in section an embodiment to the present invention in which the superelastic distal segment extends all the way to the extreme distal tip of the guidewire and in which the guidewire is also tip formable.

[0022] FIG. 7A is an enlarged view of the indicated area in FIG. 7 showing that extending radially from the longitudinal axis of the core wire to a connection between first and second spring coils, the spring coils are spaced from and circumferentially unsupported by the distal core portion at the spring coil connection.

[0023] FIG. 8 is a stress/strain curve (to break) of the materials indicated thereon.

[0024] FIG. 9 is displacement vs. load.

DETAILED DESCRIPTION OF THE INVENTION

[0025] This invention is, in one embodiment, a Dual Phase Nitinol PTCA Guidewire (see attached FIGS. 1-7) with a stainless steel proximal shaft 1 and a nitinol medial to distal section 2 (generally, the length indicated by C) attached by a nitinol hypo tube 3. This nitinol middle section is then attached to a SS distal tip 11. Distal tip 11 is attached to the nitinol section 2 by means of a spring coil 5, 7 and a ribbon wire or safety ribbon 4. Spring coil 5, 7 comprises a radiopaque segment 7 and a non-radiopaque segment 5 which overlap or are interwound and soldered together at a spring coil connection 12. Extending radially from the longitudinal axis X-X of the core wire to the connection 12, the spring coils 5, 7 are spaced from and circumferentially unsupported by the distal core portion. This spaced relationship is indicated at 100 in FIGS. 1 to 7 and generally has a length indicated by D, which extends from where the first spring coil 5 contacts the distal section 2 to the distal tip 11. In other word, the circumferential area indicated at 100 extending from the where the first spring coil 5 contacts the distal section 2 to the distal tip 11 is an open space extending radially from the longitudinal axis X-X of the core wire to the spring coil connection 12 of the first and second spring coils 5,7. The embodiment shown has two tapered or ground section 20, 21. Other combinations of tapered, ground, or flattened guidewire sections are within the contemplation of this invention.

[0026] The invention encompasses a range of constructions from floppy to extra support grind configurations. The invention preferably is built in 190 cm length and 300 cm length configurations with a preferred maximum diameter of 0.014 inches. The proximal core segment 1 is preferably PTFE coated and the distal segment 2 preferably is coated with a separate lubricious coating e.g., silicone, or other hydrophilic coating. The hydrophilic coating commercially available from Surmodics Corp. is preferred. The invention contemplates an optional extension system to be used with the 190 cm wire version having a proximal connector structure 6. A platinum distal marker coil 7 is threaded into a coil spring 5 and optional proximal depth marks on the optional PTFE-coated proximal section 8 are placed using e.g., an emulsion ink.

[0027] The nitinol middle section C will consist of a proximal linear elastic segment 9, which will graduate into a superelastic (heat-treated) segment 10 indicated by shading in all the FIGURES. The superelastic segment 10 is created by placing the desired length of core wire segment in an oven at about 1000 F. for 20 minutes. There will be a slight transition created between the linear elastic and superelastic segments that will aid in a gradual transition of lowered stiffness contributing to the variable stiffness feature of this invention. One skilled in this art will appreciate that either or both of the time of treatment or temperature of treatment of the core wire may be adjusted to obtain the requisite superelasticity. This transition length can be easily optimized to improve the overall properties of the guidewire. Other linear elastic sections may be heat-treated at lower temperatures to create more elasticity/less stiffness and a more gradual transition. (See attached test data for stiffness variations)

[0028] It has also been determined that the nitinol wire section 2 included in this invention has the ability to be straightened mechanically or by providing tension during the heat-treatment. These operations also create variable elasticity and could be used in the gradual reduction of stiffness along the guidewire.

[0029] A process has been developed that involves the heat treatment of linear elastic NiTi. The linear elastic core is placed in an oven at about 950 F. for 25 minutes with no longitudinal tension which causes the extreme distal portion of the guidewire to become superelastic. The oven is constructed in a way so that there is a void or hole in the wall of the oven where a wire can be placed. The NiTi core is inserted in to the void so that the desired length of super elastic NiTi is fully inside the oven. The heat dissipation leaving the void of the oven produces a smooth stiffness and elasticity transition from the linear to superelastic region. Stress vs. strain results have been measured and a gradual drop in stiffness from the linear elastic region to the superelastic region is clearly apparent using the above-described process. In this manner, the overall stiffness of the guidewire may be controlled by controlling the length of the core wire superelastic segment.

[0030] Thus, there is shown at FIGS. 1-7, in section, several embodiments of the present invention. It is to be understood that in each of these embodiments a distal portion of a guidewire core wire 2 comprises a more distal superelastic segment 10 and a more proximal linear elastic segment 9. In a preferred embodiment, the distal core wire or element comprises a nickel titanium alloy having a composition in the range of from about 54 atomic % nickel to 46 atomic % titanium to about 57 atomic % nickel to about 43 atomic % titanium.

[0031] In FIG. 1 there is shown an embodiment of the invention in which there is a hydrophobically-coated, e.g., PTFE, stainless steel proximal guidewire/core wire segment and a distal linear elastic 9super elastic 10, (shown by shading) core wire segment 2, the core wire terminating short of the extreme distal tip of the guidewire. The hydrophobic coating on the proximal segment of the guidewire preferably comprises PTFE. Various other hydrophobic coatings will readily come to mind to one skilled in this art in view of this disclosure. As is shown, the extreme proximal portion of the proximal guidewire segment may be coated (shorter lengths) or lack coating so as to permit the guidewire to be more easily handled.

[0032] The proximal portion (approximately the G dimension minus the B dimension) and distal segment 2 are shown to be coupled by a hypotube connector 3, each such segments having reduced diameter portions 22, 23 which are inserted into opposite ends of the hypotube connector 3 and are bonded thereto e.g., by the use of solder or glue. The hypotube connector 3 may comprise stainless steel, linear elastic or superelastic alloys depending upon design preference. Other equivalent means of creating a coupler between a stainless steel proximal segment and a linear elastic/super elastic distal segment will occur to one skilled in this art in view of the present disclosure c.f., U.S. Pat. No. 5,341,818 Abrams et al., the teachings of which are incorporated by reference herein.

[0033] There are other guidewire optional features shown in FIG. 1. For example, a spring coil is shown to be attached to the first core wire taper on its proximal end and to the guidewire tip 11 on the distal end. The spring coil extends distally to a spring coil connection 12 where the stainless steel coil 5 (SS coil) is inter-wound with a platinum core wire 7 and soldered or glued thereto 12. As is shown the platinum coil wire is inter-wound with the stainless steel coil a length sufficient to provide an aggressive yet flexible (so as not to create a flat spot) connection. Extending radially from the longitudinal axis X-X of the core wire to the connection 12, the spring coils 5, 7 are spaced from and circumferentially unsupported by the distal core portion 2 at the spring coil connection. This spaced relationship is indicated at 100 in FIGS. 1 to 7 and generally has a length indicated by D. Also optionally included in this embodiment of the invention is a generally flat stainless steel ribbon wire 4 soldered (or otherwise attached) to the core wire which extends distally to the atraumatic, extreme guidewire tip. The ribbon wire imparts finger formability to the distal segment of the guidewire.

[0034] FIGS. 2 and 3 depict variations of the invention shown in FIG. 1, the primary difference being that the shaded superelastic segment 10 begins at a zone or region that is distally-disposed relative to the comparable superelastic segment shown in FIG. 1. In FIG. 2 the superelastic segment 10 begins adjacent the first taper 20 of the guidewire distal segment. In FIG. 3, the superelastic segment 10 (shaded) is distally located from the comparable structures shown on FIGS. 1 and 2. The shorter superelastic zones or portions of the guidewires shown in FIGS. 2 and 3 mean that the distal portion of the guidewire is increasingly less floppy or conversely, stiffer. In each of the guidewires depicted in FIGS. 1, 2 and 3 a finger-formable ribbon wire 4 is used to impart finger formability to the distal segment of the guidewire. In this manner the medical professional using the guidewire may impart a desired bend or deviation from linearity, which will be retained by the guidewire.

[0035] FIG. 4 depicts the guidewire of the present invention in which the distal portion of the guidewire does not have the optional flat stainless steel ribbon wire or safety wire extending between the guidewire core and the atraumatic guidewire extreme distal tip. Also, the superelastic core wire or core element extends all the way to the atraumatic tip of the guidewire and is surrounded by the stainless steel/platinum spring coils 5, 7. The absence of the ribbon wire/safety wire means that the distal portion of the guidewire shown in FIG. 4 will not be easily finger formable. Put otherwise, the superelastic characteristics of the distal portion of the core wire will prevent it from easily retaining a bend or lateral displacement imparted thereto.

[0036] FIGS. 5 and 6 depict the guidewire shown in FIG. 4 with distally-disposed, shorter superelastic core wire segments 10. All other features of the guidewires of FIGS. 5 and 6 are the same as that of FIG. 4.

[0037] FIG. 7 shows a further embodiment to the present invention in which the superelastic core wire extends all the way to the atraumatic distal tip and a ribbon wire or safety wire 4 also is employed. The guidewire shown in FIG. 7 is otherwise the same as the guidewires shown in FIGS. 1-6.

[0038] It is to be understood that the controllable or variable stiffness of a guidewire of the present invention may also be varied or adjusted by employing one or more distal tapers. The guidewires in FIGS. 1-7 are all shown employing two such tapers 20, 21. Clearly, the number of tapers employed, their location and their length is a matter of design preference depending upon the extent of stiffness (or flexibility) to be imparted to the guidewire.

[0039] It is also to be understood that the dimensions shown for the guidewires in FIGS. 1-7 are not to be employed to limit the scope of the present invention. Without being limited thereto, dimensions shown by the use of letters in FIGS. 1-7 generally fall in the following range(s):

Drawing Letter

[0040] FIGS. 8 and 9 show the relationship between, non-super elastic, super elastic and linear elastic core wire or core element materials as a function of stress vs. strain (to break) FIG. 8, and load vs. displacement (cross head inches). Those FIGURES show the definite performance differences between the alloys and alloy states used in the present invention.

[0041] The above invention has been described with particular reference to the use of a nickel/titanium alloy to create the guidewire of variable stiffness herein described. The present invention should not be understood to be limited only to the use of nickel/titanium alloys. In fact, any alloy exhibiting the superelastic/linear elastic characteristics of nickel/titanium alloys employed herein is clearly contemplated. Thus, the present invention is not, and should not, be construed to be limited to the preferred nickel/titanium alloys extensively discussed herein.