WO2024107226A1

WO2024107226A1 - Guidewire with integrated embolic protection

Info

Publication number: WO2024107226A1
Application number: PCT/US2022/080107
Authority: WO
Inventors: Matt Casiraro; Andrzej J. Chanduszko
Original assignee: Bard Peripheral Vascular, Inc.
Priority date: 2022-11-18
Filing date: 2022-11-18
Publication date: 2024-05-23

Abstract

An embolic protective guidewire apparatus has an introducer sheath with a sheath lumen. A guidewire is configured to extend through the introducer sheath lumen and into a patient's vascular system having a vessel with a vessel lumen and an inner wall. The guidewire is sized and shaped to track through the patient's vascular system distally of the sheath and to a selected treatment site location. The guidewire has a guidewire lumen. A filter wire occupies the guidewire lumen in a first or storage position wherein the filter wire is generally straight or elongated as defined by the guidewire lumen. A second or deployed position of the filter wire extends a filter distal portion beyond the distal end of the guidewire. In the second or deployed position, the filter distal portion has a memory that forms a filter having multiple filtering portions, folded portions or loops or an irregular wire shape.

Description

TITLE OF THE INVENTION

GUIDEWIRE WITH INTEGRATED EMBOLIC PROTECTION

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an improved guidewire apparatus that can function as a guidewire or convert to an embolic protection device if needed. More particularly, the present invention relates to a guidewire apparatus having an outer tube with an inner lumen or bore that houses an inner wire (e.g., nitinol wire) that has been heat set into a selected filter shape (e.g., coil, spiral, conical coil, multiple loops or random pattern) once deployed or pushed out of the outer tube lumen.

2. General Background of the Invention

Embolic protection devices have traditionally been used during endovascular procedures with a goal to reduce the complications due to debris being released into the bloodstream and causing blockages in smaller vessels. Some embolic protection devices existing today include the RX Accunet® Embolic Protection System and SpiderFX™ Embolic Protection Device. These devices require a separate sheath where the device is collapsed during tracking and delivery. Once at the intended location, the device is advanced out of its sheath.

The following U.S. Patent documents, which are incorporated herein by reference, are nnccihl KAI Avant

BRIEF SUMMARY OF THE INVENTION

The present invention is a guidewire apparatus that can convert to an embolic protection device if needed. The tip of the outer tube or guidewire could be in an atraumatic shape such as a hemisphere (or domed). The outer tube or guidewire has a lumen or bore that houses a filter/embolic protection wire having a coil shape with multiple loops (e.g., conically shaped or tapered) or multiple folded portions or an irregular wire shape. The filter loops or folded portions could be compressible. The filter can have a closed end and a cavity that collects emboli. The filter dimensions could be selected to match a human vessel wall, although one filter size could cover a wide vessel diameter range due to compressibility of the filter. The distance between coil wires can range from zero to 1mm or more depending on the application. If a filter is comprised of multiple folded portions, there could be openings or open spaces between folded portions of the filter that would be sized and shaped to (configured to) disallow passage of emboli.

The embolic protection device or filter would be preferably manufactured from a wire that could form a selected shape after extension beyond the guidewire (e.g., see Figures 3-14). The wire could be a Nitinol wire that would be heat set to a spiral or coil shape or irregular wire or other shape. The distal end of the wire can be radiopaque by attaching a radiopaque marker such as a gold or platinum alloy. The guidewire could be a guidewire of standard size and shape. The guidewire could be produced using a hypotube, which can be made of nitinol or other suitable material.

During clinical use as an embolic protection device / guidewire, the proposed device could be used in conjunction with a standard procedural sheath. The guidewire would be introduced into vasculature and tracked past the treatment site location. During such insertion into vasculature, the filter wire would be housed within the guidewire lumen and assume the shape of the guidewire lumen (e.g, straight or elongated). A filter wire distal portion would then be advanced out of the guidewire distal tip. As the filter wire is advanced out of the guidewire lumen, a cone or tapered filter is formed because of memory of a filter section of the filter wire. Alternatively, the filter could be formed of multiple folded portions or as an irregular wire shape (see Figures 14-15). Debris captured during an endovascular procedure, such as an atherectomy, would be captured in the filter. Captured debris would be pulled into the procedural sheath completing the procedure. Optionally, an additional aspiration sheath may be advanced through the same procedural introducer sheath that was used for the guidewire. The aspiration sheath could be advanced to the fdter and into a fdter cavity. A physician could then aspirate embolic material from the fdter before the fdter is withdrawn into the procedural sheath, by using a syringe, for example.

The present invention eliminates the fdter sheath and/or separate wire which reduces cost and extra procedural steps (reduces complexity) during use of procedures seeking embolic protection. Since a guidewire is needed anyways to track, the present invention can eliminate the need for a separate embolic protection device or separate guidewire, thus reducing procedural costs and simplifying inventory.

The present invention potentially reduces the profde of the introducer sheath utilized since a separate embolic protection wire/sheath does not need to be present and take up space. Further reduction in the profde of the introducer sheath depends on the application as foreign object removal requires some space for object to be removed in the procedural sheath. Ultimately, the introducer sheath will be based upon the atherectomy or balloon devices required but this only helps with real estate and space. If additional procedural tasks are needed, the guidewire (e.g., 0.035 inch diameter) could be used. Thus, the present invention eliminates the need to pull an additional guidewire. If nothing (embolic, debris) is captured, the fdter portion (e.g., nitinol coil) could be pulled back into the guidewire providing structural support.

The fdtering element can be comprised of superelastic nitinol and is preferably heat shaped into a selected fdter shape such as a spiral configuration (or a folded or irregular wire configuration of Figures 14, 15) during manufacturing. The inner wire/fdter can be loaded into the outer guidewire by pulling the fdter portion into this outer guidewire. By pulling the fdter portion or fdter wire into the guidewire lumen, the fdter portion or fdter wire is effectively turned into a straight or elongated wire while maintaining its heat set properties.

During clinical use, the fdtering portion or element (e.g., spiral, conical, folded, or irregular wire) is advanced out of the guidewire lumen. Since the fdter wire material is heat set (e.g., nitinol) the fdter wire reconfigures into its original heat set shape once so deployed (see Figures 3-15). The fdter then collects emboli generated during the procedure.

There are three methods to retrieve the fdter and filtered emboli. The fdter (e.g., spiral, conical, folded, or irregular wire) can be pulled back into the introducer sheath squeezing the clot into the sheath. Suction can be activated through the sheath during filter retrieval so the emboli or debris is aspirated while the filter is being retracted. A separate suction catheter can be used to aspirate the emboli and then the filter wire can be pulled back into either the outer guidewire or introducer sheath.

Deploying an oversized filter (oversized relative to vessel wall to anchor) will provide stability to the larger part of the coil (large radius coils would be stabilized by vessel wall) while the smaller diameter part of the coil is stiff/strong due to its geometry/tight radius.

The present invention provides an embolic protective guidewire apparatus. In one or more embodiments, the apparatus comprises: an introducer sheath having a sheath lumen; a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall, the guidewire having a distal end and a proximal end; the guidewire sized and shaped (configured) to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; the guidewire having a guidewire lumen; a filter wire that occupies the guidewire lumen in a storage position wherein the filter wire is, in the storage position, elongated and generally straight as defined by the guidewire lumen; a deployed position of the filter wire that extends a filter wire distal portion beyond the distal end of the guidewire; and wherein in the deployed position, the filter wire distal portion has a memory that forms a filter with filter openings that enable blood flow through the filter openings while trapping emboli or debris that are too large to pass through the filter openings.

In various embodiments, the embolic protection guidewire apparatus filter can be a spiral having a diameter that extends to the vessel inner wall at said treatment site location.

In various embodiments, the embolic protection guidewire apparatus filter can be compressible when the filter is moved relative to the vessel inner wall.

In various embodiments, the filter can include a spiral which has a compressibility that enables the spiral to fit a range of vessel lumen diameters.

In various embodiments, the spiral can have a tapered shape.

In various embodiments, the filter can enable removal of filtered emboli by pulling of the filter into the introducer sheath.

In various embodiments, the apparatus can further comprise a source of suction and the filter can enable removal of filtered emboli by application of a suction catheter or tube through the introducer sheath.

In various embodiments, the apparatus can further comprise a suction catheter that enables aspiration of any emboli that are contained in the fdter.

In various embodiments, the guidewire can have a diameter of between 0.014 and 0.038 inches.

In various embodiments, the guidewire can have a diameter of about 0.035 inches.

In various embodiments, the guidewire can have an inner lumen diameter of between 0.010 and 0.025 inches.

In various embodiments, the fdter wire can have a diameter of between 0.010 and 0.025 inches.

In one or more embodiments, the present invention provides an embolic protective guidewire apparatus comprising: an introducer sheath having a sheath lumen; a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system, the guidewire having a distal end and a proximal end; wherein said guidewire is sized and shaped (configured) to track beyond the introducer sheath and into a patient’s vascular system and to a selected treatment site that is spaced away from the introducer sheath; said guidewire having a guidewire lumen; a filter that occupies the guidewire lumen in a first position wherein the filter has a shape that is defined by the shape of the guidewire lumen; a second position of the filter that extends a filter distal portion beyond the distal end of the guidewire; and wherein the second position, the filter distal portion has a memory that forms a filter with filter openings that prevent travel of emboli or debris downstream of the filter.

In various embodiments, the guidewire enables access to a selected treatment site wherein the filter remains contained within the guidewire lumen in a storage position.

In various embodiments, the guidewire can have an atraumatic distal tip and wherein the guidewire lumen extends to said distal tip.

In various embodiments, the filter can include multiple loops. The distance between the loops can be between 0.01 and 1.0 mm. At least some of the loops can be of differing diameters.

In various embodiments, the filter can be tapered distally.

In various embodiments, the filter distal portion can have an irregular wire shape that includes multiple folded portions.

In various embodiments, the filter can have an outer diameter that matches the diameter of a vessel wall.

In one more embodiments, the present invention provides an embolic protective guidewire apparatus comprising: an introducer sheath having a sheath lumen; a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a treatment site; said guidewire sized and shaped (configured) to track through the patient’s vascular system and to the treatment site; said guidewire having a guide wire lumen and distal and proximal ends; a filter that occupies the guidewire lumen in a first position wherein the filter is elongated and generally straight as defined by the guidewire lumen; a second position of the filter that extends a filter distal portion beyond the distal end of the guidewire; and wherein the second position, the filter includes a portion that expands to form a filter structure with a diameter that approximates the vessel diameter.

In one or more embodiments, the present invention provides an embolic protective guidewire apparatus comprising: an introducer sheath having a sheath lumen; a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall; said guidewire sized and shaped (configured) to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; said guidewire having a guidewire lumen; an inner wire that occupies the guidewire lumen in a first position wherein the inner wire is generally straight as defined by the guidewire lumen; a second position of the inner wire that extends an inner wire distal portion beyond the distal end of the guidewire; and wherein in the second position, the inner wire distal portion has a memory that forms a filter having multiple folded portions and filter openings in between the folded portions.

In one or more embodiments, the guidewire can have an outer diameter between 0.014 and 0.038 inches.

In one or more embodiments, the guidewire lumen can have a diameter between 0.010 and 0.025 inches.

In one or more embodiments, the inner wire can have a diameter between 0.008 and 0.023 inches.

In one or more embodiments, the filter can have a diameter that matches the diameter of the vessel inner wall at said treatment site location.

In one or more embodiments, the present invention provides an embolic protective guidewire apparatus comprising: an introducer sheath having a sheath lumen; a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall, the guidewire having a distal end and a proximal end; said guidewire sized and shaped (configured) to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; said guidewire having a guidewire lumen; an inner wire that occupies the guidewire lumen in a first position wherein the inner wire is generally straight as defined by the guidewire lumen; a second position of the inner wire that extends an inner wire distal portion beyond the distal end of the guidewire; and wherein in the second position, the inner wire distal portion has a memory that forms an embolic filter of multiple looped portions.

In one or more embodiments, the present invention provides a guidewire apparatus comprising: an outer wire having an inner lumen, said outer wire sized and shaped (configured) to be guided through a selected portion of a patient’s vascular system; an inner wire movably mounted in said outer wire lumen between a stored position wherein said inner wire has a shape that assumes the shape of the outer wire lumen; the inner wire having a deployed position that positions a part of the inner wire distally of the outer wire inner lumen; wherein the inner wire has a memory that forms a generally conically shaped filter in said deployed position; and wherein the filter includes a randomly shaped portion having multiple irregular folds or loops. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:

Figure l is a partial side view of a preferred embodiment of the apparatus of the present invention;

Figure 2 is a partial side view of a preferred embodiment of the apparatus of the present invention;

Figure 3 is a perspective view of a preferred embodiment of the apparatus of the present invention; Figure 4 is a perspective view of a preferred embodiment of the apparatus of the present invention shown with optional aspiration sheath;

Figure 5 is a partial side view of a preferred embodiment of the apparatus of the present invention;

Figure 6 is a fragmentary side view of a preferred embodiment of the apparatus of the present invention;

Figure 7 is an end view of a preferred embodiment of the apparatus of the present invention taken along lines 7-7 of Figures 5 and 6;

Figure 8 is a fragmentary side view of a preferred embodiment of the apparatus of the present invention wherein the fdter has a shape with cylindrical and conical portions;

Figure 9 is an end view taken along lines 9-9 of Figure 8;

Figure 10 is a fragmentary side view of a preferred embodiment of the apparatus of the present invention wherein the fdter has a shape with cylindrical portions;

Figure 11 is an end view taken along lines 5-5 of Figure 10;

Figure 12 is an end view taken along lines 6-6 of Figure 10;

Figure 13 is an end view taken along lines 6-6 of Figure 10 wherein the inner wire is marked with shading;

Figure 14 is a fragmentary side view of a preferred embodiment of the apparatus of the present invention wherein the fdter has a shape with folded portions; and

Figure 15 is an end view taken along lines 8-8 of Figure 14.

DETAILED DESCRIPTION OF THE INVENTION

Figures 1-15 show various preferred embodiments of the apparatus of the present invention, a first embodiment which is designated generally by the numeral 10 as seen in Figure 3. A second embodiment is designated by the numeral 110 (see Figures 8-9). A third embodiment is designated by numeral 210 (see Figures 10-13). A fourth embodiment is designated by the numeral 310 (see Figures 14-15). Guidewire and embolic protection apparatus 10, 110, 210, and 310 can be inserted into a patient’s vascular system with a sheath or insertion sheath 11 (commercially available) having sheath lumen 12. An outer tube member or guidewire 16 extends into sheath lumen 12 and then into a patient’s vascular system such as a selected blood vessel 13. Vessel 13 has vessel lumen 14 and vessel wall 15. Guidewire 16 has central longitudinal axis 30. Guidewire 16 has guidewire lumen 17, guidewire wall 18 surrounding lumen 17 and outer surface 19. Guidewire 16 has distal end portion 21 and proximal end portion 22. A guidewire tip 20 is at distal end portion 21 as seen in Figures 1-4. Tip 20 can be an atraumatic tip such as hemispherical or domed tip 20. Occupying lumen 17 of guidewire 16 is inner wire or filter wire 23.

When inner wire or filter wire 23 occupies guidewire 16 lumen 17, it assumes the shape of lumen 17, typically straightened or elongated as seen in Figures 1-2. Inner wire 23 has central longitudinal axis 30 when stored within lumen 17 of guidewire 16. When a physician or technician advances inner wire 23 beyond (i.e., distally ol) tip 20, a filter section forms as seen in Figures 3-14 (see filter section 26 of Figures 3-7, filter section 35 of Figures 8-9, filter section 39 of Figures 10-13, and filter section 41 of Figures 14-15). The inner wire 23 forms the filter shape or filter section 26 of Figures 3-7 which includes a largest or larger diameter coil 28, a smallest or smaller diameter coil 29 at distal end portion 25 and having other coils or spirals in between largest coil 28 and smallest coil 29 as seen in Figures 3-7. The coils of spiral shaped filter section 26 can be about one (1) millimeter apart or can range between 0.01 millimeters and one (1) millimeter apart or more so that debris or emboli are trapped in cavity 32 while blood flow passes through spaces 31 (see Figure 6, for example).

Larger or largest coil 28 could be a diameter that is equal to or that approximates the vessel 13 lumen 14 diameter (see Figure 6). The spiral section or filter section 26 could be cone shaped between larger diameter coil 28 and smaller diameter coil 29 as seen in Figures 3- 6. Other shapes for filter section 26 could be cylindrical (see Figure 10), folded, an irregular wire shape (see Figures 14-16) or a combination of conical and cylindrical (see Figure 8) as examples.

Filter section 26 could be heat set to the spiral or coil shape of Figures 3-7 or the shapes of Figures 8-15. During clinical use as an embolic protection guidewire, the proposed apparatus 10, 110, 210, 310 would be used in conjunction with a standard procedural sheath 11. The guidewire 16 would be introduced via sheath 11 into vasculature (e.g., vessel 13) and tracked past a selected treatment site location. The fdter wire 23 would be advanced out of the guidewire tip 20. As the wire 23 is advanced out of guidewire bore / lumen 17, a selected fdter section 26, 35, 39, 41 is formed (Figures 3-15). Debris captured during an endovascular procedure, such as atherectomy, would be captured in fdter section 26, 35, 39, 41 cavity 32 and pulled into the procedural sheath 11 completing the procedure. In Figures 14-15 emboli, clot(s) or debris would be trapped by the various sections or irregular wire 44 as the emboli or debris would be larger than openings 42, 43. Optionally, an additional aspiration sheath 33 (see Figure 4) may be advanced through the same procedural introducer sheath 11 as the guidewire 16. The aspiration sheath 33 would be advanced into the filter cavity 32 as seen in Figure 4. A physician could then use a syringe connected to a proximal end of sheath 33 to aspirate embolic material from the filter 23 cavity 32 before the filter section 26, 35, 39, 41 of filter wire 23 is withdrawn into the procedural sheath 11. Filter section 26, 35, 39, 41 would connect to a proximal section 34 (see Figures 5, 6, 8, 10, 14) of inner wire/fdter wire 23 via radially extending section 27. The proximal section 34 would remain in guidewire 16 lumen 17 (see Figure 3) so that a physician could manipulate the filter wire 23 and thus the filter section 26 by grasping proximal end portion 24 which extends proximally of guidewire 16 proximal end 22 (see Figure 3).

Figures 8-9 illustrate that the filter section 26 of Figures 3-7 can have a different configuration or shape. In Figures 8-9, a filter section 35 is provided that connects to wire or filter 23 proximal section 34 with radially extending portion 27. The filter section 35 includes cylindrically shaped section 36 and conically shaped section 37 having distal tip 38. Filter section 35 can be one continuous spiral that extends from radially extending section 27 to tip 38 and including multiple coils with spaces in between the coils as with Figures 1-7.

In Figures 10-13, a filter section 39 extends distally from radially extending portion 27. As with the filter section 26 of Figures 3-7, filter section 39 can be comprised of two main sections, a fixed diameter spiral/helix section comprised of multiple loops or coils 47 between section or portion 27 and tip 40 with a space 31 between each pair of loops or coils as with Figures 8 and 9 and an end section 48 with a spiral with a variable diameter, wherein the diameter decreases as the coil 23 moves inwardly towards tip 40, from an outer diameter approximately equal to the diameter of the vessel lumen 14, terminating at tip 40.

In Figures 14-15, the filter section 41 extends distally of wire/filter 23 proximal section 34. In Figures 14-15, filter section 41 has an irregular wire shape that includes irregular loop or sections 44 with openings, apertures, voids or void spaces 43 or voids 43 and in between section voids or spaces 42 as seen in Figure 14. As seen in Figures 14 and 15, filter section 41 can extend in both proximal and distal directions, as well as radially towards the vessel 13 wall 15 and back towards a central point, in a seemingly random manner. Openings, apertures, voids or void spaces 43 can be placed in between filter section 41 and vessel 13 wall 15 as seen in Figures 14-15. Filter section 41 has end or tip 45. By varying the number of irregular loop or folded sections 44 in between filter section 41 end portions 45 and 46, a desired size of each emboli or item of debris can be captured or filtered while allowing other blood to flow through the filter section 41.

Without limitation, the apparatus may further be characterized by one or more of the following statements:

Statement 1 : An embolic protective guidewire apparatus for a patient’s vascular system having a vessel with a vessel lumen and an inner wall, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein the guidewire has a distal end and a proximal end, wherein said guidewire is configured to track through the patient’s vascular system distally of said sheath and to a selected treatment site location, and wherein the guidewire has a guidewire lumen; c) a filter wire that occupies the guidewire lumen, wherein in a storage position, the filter wire is elongated and generally straight as defined by the guidewire lumen, and wherein in a deployed position the filter wire is shaped such that the filter wire has a filter wire distal portion that extends beyond the distal end of the guidewire; and the filter wire distal portion has a memory that forms a filter with filter openings configured to enable blood flow through the filter openings while trapping emboli or debris larger than the filter openings.

Statement 2: The embolic protection guidewire apparatus of statement 1, wherein the filter is spiral-shaped and has a diameter for extending to the vessel inner wall at said treatment site location.

Statement 3: The embolic protection guidewire apparatus of statement 1 or 2, wherein the filter is compressible when the filter is moved relative to the vessel inner wall.

Statement 4: The embolic protection guidewire apparatus of statement 2, wherein the filter has a compressibility for a range of vessel lumen diameters.

Statement 5: The embolic protection guidewire apparatus of statement 2 or 4, wherein the filter has a tapered shape.

Statement 6: The embolic protection guidewire apparatus of one or more of the preceding statements, wherein the filter is configured to remove filtered emboli when the filter is pulled into the introducer sheath.

Statement 7: The embolic protection guidewire apparatus of one or more of the preceding statements, further comprising a source of suction and wherein the source of suction is configured to remove filtered emboli through the introducer sheath.

Statement 8: The embolic protection guidewire apparatus of one or more of the preceding statements, further comprising a suction catheter and wherein the suction catheter is configured to aspirate any emboli that are contained in the filter.

Statement 9: The embolic protection guidewire apparatus of one or more of the preceding statements, wherein the guidewire has a diameter of between 0.014 and 0.035 inches.

Statement 10: The embolic protection guidewire apparatus of one or more of the preceding statements, wherein the guidewire has a diameter of about 0.035 inches.

Statement 11: The embolic protection guidewire apparatus of one or more of the preceding statements, wherein the guidewire has an inner lumen diameter of between 0.010 and 0.025 inches.

Statement 12: The embolic protection guidewire apparatus of one or more of the preceding statements, wherein the filter wire has a diameter of between 0.010 and 0.025 inches.

Statement 13: An embolic protective guidewire apparatus for a patient’s vascular system, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein the guidewire has a distal end and a proximal end, wherein said guidewire is configured to track beyond the introducer sheath and into the patient’s vascular system and to a selected treatment site that is spaced away from the introducer sheath, and wherein said guidewire has a guidewire lumen; c) a filter that occupies the guidewire lumen, wherein in a first position the filter is shaped such that the filter is held in the guidewire lumen, and wherein in a second position, the filter is shaped such that the filter has a filter distal portion that extends beyond the distal end of the guidewire; and wherein in the second position, the filter distal portion has a memory that forms filter openings configured to prevent travel of emboli or debris downstream of the filter.

Statement 14: The embolic protection guidewire apparatus of statement 13, wherein the guidewire enables access to a selected treatment site wherein the filter remains contained within the guidewire lumen in a storage position.

Statement 15: The embolic protection guidewire apparatus of one or more of statements 13 or 14, wherein the guidewire has an atraumatic distal tip and wherein the guidewire lumen extends to said distal tip.

Statement 16: The embolic protection guidewire apparatus of one or more of statements 13-15, wherein the filter includes multiple loops.

Statement 17: The embolic protection guidewire apparatus of statement 16, wherein a distance between two neighbouring loops of the multiple loops is between 0.01 and 1.0 mm.

Statement 18: The embolic protection guidewire apparatus of one or more of statements 16-17, wherein at least some of the multiple loops have a diameter different from other loops of the multiple loops.

Statement 19: The embolic protection guidewire apparatus of one or more of statements 13-18, wherein the filter is tapered distally.

Statement 20: The embolic protection guidewire apparatus of one or more of statements 13-19, wherein the filter distal portion has a wire shape that includes multiple irregularly folded portions.

Statement 21: The embolic protection guidewire apparatus of one or more statements 13-20, wherein the filter has an outer diameter configured to extend to a vessel inner wall of the patient’s vascular system.

Statement 22: An embolic protective guidewire apparatus for a patient’s vascular system having a vessel with a treatment site, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein said guidewire is configured to track through the patient’s vascular system and to the treatment site, and wherein said guidewire has a guidewire lumen and distal and proximal ends; c) a filter that occupies the guidewire lumen, wherein in a first position the filter is elongated and generally straight as defined by the guidewire lumen, and wherein in a second position the filter is shaped such that the filter has a filter distal portion that extends beyond the distal end of the guidewire; and wherein in the second position, the filter includes a filter structure portion having a diameter for extending to an inner wall of the vessel.

Statement 23: An embolic protective guidewire apparatus for a patient’s vascular system having a vessel with a vessel lumen and an inner wall, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein said guidewire is configured to track through the patient’s vascular system distally of said sheath and to a selected treatment site location, and wherein said guidewire has a guidewire lumen; c) an inner wire that occupies the guidewire lumen, wherein in a first position, the inner wire is generally straight as defined by the guidewire lumen, and in a second position, the inner wire is shaped such that the inner wire has an inner wire distal portion that extends beyond the distal end of the guidewire, and wherein in the second position, the inner wire distal portion has a memory that forms a filter having multiple folded portions and filter openings in between the multiple folded portions.

Statement 24: The embolic protective guidewire apparatus of statement 22 or 23, wherein the guidewire has an outer diameter between 0.014 and 0.035 inches.

Statement 25: The embolic protective guidewire apparatus of statement 22 or 23, wherein the guidewire lumen has a diameter between 0.010 and 0.025 inches.

Statement 26: The embolic protective guidewire apparatus of statement 22 or 23, wherein the inner wire has a diameter between 0.008 and 0.023 inches.

Statement 27: The embolic protective guidewire apparatus of statement 22 or 23, wherein the filter has a diameter configured to extend to the vessel inner wall at said treatment site location.

Statement 28: An embolic protective guidewire apparatus for a patient’s vascular system having a vessel with a vessel lumen and an inner wall, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein the guidewire has a distal end and a proximal end, wherein said guidewire is configured to track through the patient’s vascular system distally of said sheath and to a selected treatment site location, and wherein said guidewire has a guidewire lumen; c) an inner wire that occupies the guidewire lumen, wherein in a first position, wherein the inner wire is generally straight as defined by the guidewire lumen, and wherein in a second position, the inner wire is shaped such that the inner wire has an inner wire distal portion that extends beyond the distal end of the guidewire, and wherein in the second position, the inner wire distal portion has a memory that forms an embolic filter of multiple looped portions.

29. A guidewire apparatus, comprising: a) an outer wire having an inner lumen, said outer wire configured to be guided through a selected portion of a patient’s vascular system; b) an inner wire movably mounted in said inner lumen, wherein in a stored position, said inner wire has a shape defined by the inner lumen, and wherein in a deployed position, the inner wire is shaped such that the inner wire has a portion that positions distally of the inner lumen, wherein the inner wire has a memory that forms a generally conically shaped filter in said deployed position; and wherein the filter includes a randomly shaped portion having multiple irregular folds or loops.

Statement 30: An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall, the guidewire having a distal end and a proximal end; c) said guidewire sized and shaped to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; d) said guidewire having a guidewire lumen; e) a filter wire that occupies the guidewire lumen in a storage position wherein the filter wire is, in the storage position, elongated and generally straight as defined by the guidewire lumen;

1) a deployed position of the filter wire that extends a filter wire distal portion beyond the distal end of the guidewire; and g) wherein in the deployed position, the filter wire distal portion has a memory that forms a filter with filter openings that enable blood flow through the filter openings while trapping emboli or debris that are too large to pass through the filter openings. Statement 31: The embolic protection guidewire apparatus of statement 30 wherein the filter is a spiral having a diameter that extends to the vessel inner wall at said treatment site location.

Statement 32: The embolic protection guidewire apparatus of statement 30 or 31 wherein the filter is compressible when the filter is moved relative to the vessel inner wall.

Statement 33: The embolic protection guidewire apparatus of statement 31 wherein the spiral has a compressibility that enables the spiral to fit a range of vessel lumen diameters.

Statement 34: The embolic protection guidewire apparatus of statement 31 or 33 wherein the spiral has a tapered shape.

Statement 35: The embolic protection guidewire apparatus of one or more of the preceding statements wherein the filter enables removal of filtered emboli by pulling of the filter into the introducer sheath.

Statement 36: The embolic protection guidewire apparatus of one or more of the preceding statements further comprising a source of suction and wherein the filter enables removal of filtered emboli by application of a suction catheter or tube through the introducer sheath.

Statement 37: The embolic protection guidewire apparatus of one or more of the preceding statements further comprising a suction catheter that enables aspiration of any emboli that are contained in the filter.

Statement 38: The embolic protection guidewire apparatus of one or more of the preceding statements wherein the guidewire has a diameter of between 0.014 and 0.035 inches.

Statement 39: The embolic protection guidewire apparatus of one or more of the preceding statements wherein the guidewire has a diameter of about 0.035 inches.

Statement 40: The embolic protection guidewire apparatus of one or more of the preceding statements wherein the guidewire has an inner lumen diameter of between 0.010 and 0.025 inches.

Statement 41: The embolic protection guidewire apparatus of one or more of the preceding statements wherein the filter wire has a diameter of between 0.010 and 0.025 inches.

Statement 42: An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system, the guidewire having a distal end and a proximal end; c) wherein said guidewire is sized and shaped to track beyond the introducer sheath and into a patient’s vascular system and to a selected treatment site that is spaced away from the introducer sheath; d) said guidewire having a guidewire lumen; e) a filter that occupies the guidewire lumen in a first position wherein the filter has a shape that is defined by the shape of the guidewire lumen;

1) a second position of the filter that extends a filter distal portion beyond the distal end of the guidewire; and g) wherein the second position, the filter distal portion has a memory that forms a filter with filter openings that prevent travel of emboli or debris downstream of the filter.

Statement 43: The embolic protection guidewire apparatus of statement 13 wherein the guidewire enables access to a selected treatment site wherein the filter remains contained within the guidewire lumen in a storage position.

Statement 44: The embolic protection guidewire apparatus of one or more of statements 42 or 43 wherein the guidewire has an atraumatic distal tip and wherein the guidewire lumen extends to said distal tip.

Statement 45: The embolic protection guidewire apparatus of one or more of statements 13-15 wherein the filter includes multiple loops.

Statement 46: The embolic protection guidewire apparatus of statement 16 wherein there is a distance between the loops between 0.01 and 1.0 mm.

Statement 47: The embolic protection guidewire apparatus of one or more of statements 45-46 wherein at least some of the loops are of differing diameters.

Statement 48: The embolic protection guidewire apparatus of one or more of statements 42-47 wherein the filter is tapered distally.

Statement 49: The embolic protection guidewire apparatus of one or more of statements 42-48 wherein the filter distal portion has an irregular wire shape that includes multiple folded portions.

Statement 50: The embolic protection guidewire apparatus of one or more statements 42-49 wherein the filter has an outer diameter that matches the diameter of a vessel wall.

Statement 51: An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a treatment site; c) said guidewire sized and shaped to track through the patient’s vascular system and to the treatment site; d) said guidewire having a guide wire lumen and distal and proximal ends; e) a filter that occupies the guidewire lumen in a first position wherein the filter is elongated and generally straight as defined by the guidewire lumen; f) a second position of the filter that extends a filter distal portion beyond the distal end of the guidewire; and g) wherein the second position, the filter includes a portion that expands to form a filter structure with a diameter that approximates the vessel diameter.

Statement 52: An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall; c) said guidewire sized and shaped to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; d) said guidewire having a guidewire lumen; e) an inner wire that occupies the guidewire lumen in a first position wherein the inner wire is generally straight as defined by the guidewire lumen; f) a second position of the inner wire that extends an inner wire distal portion beyond the distal end of the guidewire; and g) wherein in the second position, the inner wire distal portion has a memory that forms a filter having multiple folded portions and filter openings in between the folded portions.

Statement 53: The embolic protective guidewire apparatus of statement 51 or 52 wherein the guidewire has an outer diameter between 0.014 and 0.035 inches.

Statement 54: The embolic protective guidewire apparatus of statement 51 or 52 wherein the guidewire lumen has a diameter between 0.010 and 0.025 inches.

Statement 55: The embolic protective guidewire apparatus of statement 51 or 52 wherein the inner wire has a diameter between 0.008 and 0.023 inches.

Statement 56: The embolic protective guidewire apparatus of statement 51 or 52 wherein the fdter has a diameter that matches the diameter of the vessel inner wall at said treatment site location.

Statement 57: An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall, the guidewire having a distal end and a proximal end; c) said guidewire sized and shaped to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; d) said guidewire having a guidewire lumen; e) an inner wire that occupies the guidewire lumen in a first position wherein the inner wire is generally straight as defined by the guidewire lumen; f) a second position of the inner wire that extends an inner wire distal portion beyond the distal end of the guidewire; and g) wherein in the second position, the inner wire distal portion has a memory that forms an embolic filter of multiple looped portions.

58. A guidewire apparatus, comprising: a) an outer wire having an inner lumen, said outer wire sized and shaped to be guided through a selected portion of a patient’s vascular system; b) an inner wire movably mounted in said outer wire lumen between a stored position wherein said inner wire has a shape that assumes the shape of the outer wire lumen; c) the inner wire having a deployed position that positions a part of the inner wire distally of the outer wire inner lumen; d) wherein the inner wire has a memory that forms a generally conically shaped filter in said deployed position; and e) wherein the filter includes a randomly shaped portion having multiple irregular folds or loops.

The following is a list of parts and materials suitable for use in the present invention: PARTS LIST

PART NUMBER DESCRIPTION

5 line

6 line

7 line

8 line

9 line

10 guidewire and embolic protection apparatus

11 sheath/procedural sheath/insertion sheath

12 sheath/lumen

13 blood vessel /vasculature

14 vessel lumen

15 vessel wall

16 guidewire/outer member/ outer tube member

17 guidewire lumen/bore

18 guidewire wall

19 guidewire outer surface

20 guidewire tip/dome/hemispherical tip

21 distal end portion

22 proximal end portion

23 filter/filter wire/inner wire

24 proximal end portion

25 distal end portion

26 distal protection device/filter section/spiral section

27 radially extending portion or section

28 larger diameter coil / largest diameter coil

29 smaller diameter coil / smallest diameter coil

30 central longitudinal axis

31 space between coils

32 filter cavity 33 aspiration sheath

34 proximal section

35 filter section / protection device

36 cylindrically shaped section

37 conically shaped section

38 tip/distal tip

39 filter section / protection device

40 tip

41 filter section

42 spaces/void/openings

43 spaces/void/openings

44 folded section/irregular wire

45 end / tip

46 end portion

47 loop / coil

48 loop / coil

49 end portion

The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.

Claims

1. An embolic protective guidewire apparatus for a patient’s vascular system having a vessel with a vessel lumen and an inner wall, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein the guidewire has a distal end and a proximal end, wherein said guidewire is configured to track through the patient’s vascular system distally of said sheath and to a selected treatment site location, and wherein the guidewire has a guidewire lumen; c) a filter wire that occupies the guidewire lumen, wherein in a storage position, the filter wire is elongated and generally straight as defined by the guidewire lumen, and wherein in a deployed position, the filter wire is shaped such that the filter wire has a filter wire distal portion that extends beyond the distal end of the guidewire; and the filter wire distal portion has a memory that forms a filter with filter openings configured to enable blood flow through the filter openings while trapping emboli or debris larger than the filter openings.

2. The embolic protection guidewire apparatus of claim 1, wherein the filter is spiral-shaped and has a diameter for extending to the vessel inner wall at said treatment site location.

3. The embolic protection guidewire apparatus of claim 1, wherein the filter is compressible when the filter is moved relative to the vessel inner wall.

4. The embolic protection guidewire apparatus of claim 2, wherein the filter has a compressibility for a range of vessel lumen diameters.

5. The embolic protection guidewire apparatus of claim 2, wherein the filter has a tapered shape.

6. The embolic protection guidewire apparatus of claim 1, wherein the filter is configured to remove filtered emboli when the filter is pulled into the introducer sheath.

7. The embolic protection guidewire apparatus of claim 1, further comprising a source of suction and wherein the source of suction is configured to remove filtered emboli through the introducer sheath.

8. The embolic protection guidewire apparatus of claim 1, further comprising a suction catheter and wherein the suction catheter is configured to aspirate any emboli that are contained in the filter.

9. The embolic protection guidewire apparatus of claim 1, wherein the guidewire has a diameter of between 0.014 and 0.035 inches.

10. The embolic protection guidewire apparatus of claim 1, wherein the guidewire has a diameter of about 0.035 inches.

11. The embolic protection guidewire apparatus of claim 1, wherein the guidewire has an inner lumen diameter of between 0.010 and 0.025 inches.

12. The embolic protection guidewire apparatus of claim 1, wherein the filter wire has a diameter of between 0.010 and 0.025 inches.

13. An embolic protective guidewire apparatus for a patient’s vascular system, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein the guidewire has a distal end and a proximal end, wherein said guidewire is configured to track beyond the introducer sheath and into the patient’s vascular system and to a selected treatment site that is spaced away from the introducer sheath, and wherein said guidewire has a guidewire lumen; c) a filter that occupies the guidewire lumen, wherein in a first position, the filter is shaped such that the filter is held in the guidewire lumen, and wherein in a second position, the filter is shaped such that the filter has a filter distal portion that extends beyond the distal end of the guidewire; and wherein in the second position, the filter distal portion has a memory that forms filter openings configured to prevent travel of emboli or debris downstream of the filter.

14. The embolic protection guidewire apparatus of claim 13, wherein the guidewire enables access to a selected treatment site wherein the filter remains contained within the guidewire lumen in a storage position.

15. The embolic protection guidewire apparatus of claim 13, wherein the guidewire has an atraumatic distal tip and wherein the guidewire lumen extends to said distal tip.

16. The embolic protection guidewire apparatus of claim 13, wherein the filter includes multiple loops.

17. The embolic protection guidewire apparatus of claim 16, wherein a distance between two neighbouring loops of the multiple loops is between 0.01 and 1.0 mm.

18. The embolic protection guidewire apparatus of claim 16, wherein at least some of the multiple loops have a diameter different from other loops of the multiple loops.

19. The embolic protection guidewire apparatus of claim 13, wherein the filter is tapered distally.

20. The embolic protection guidewire apparatus of claim 13, wherein the filter distal portion has a wire shape that includes multiple irregularly folded portions.

21. The embolic protection guidewire apparatus of claim 13, wherein the filter has an outer diameter configured to extend to a vessel inner wall of the patient’s vascular system.

22. An embolic protective guidewire apparatus for a patient’s vascular system having a vessel with a treatment site, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein said guidewire is configured to track through the patient’s vascular system and to the treatment site, and wherein said guidewire has a guidewire lumen and distal and proximal ends; c) a filter that occupies the guidewire lumen, wherein in a first position, the filter is elongated and generally straight as defined by the guidewire lumen, and wherein in a second position, the filter is shaped such that the filter has a filter distal portion that extends beyond the distal end of the guidewire; and wherein in the second position, the filter includes a filter structure portion having a diameter for extending to an inner wall of the vessel.

23. An embolic protective guidewire apparatus for a patient’s vascular system having a vessel with a vessel lumen and an inner wall, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein said guidewire is configured to track through the patient’s vascular system distally of said sheath and to a selected treatment site location, and wherein said guidewire has a guidewire lumen; c) an inner wire that occupies the guidewire lumen, wherein in a first position, the inner wire is generally straight as defined by the guidewire lumen, and in a second position, the inner wire is shaped such that the inner wire has an inner wire distal portion that extends beyond the distal end of the guidewire, and wherein in the second position, the inner wire distal portion has a memory that forms a filter having multiple folded portions and filter openings in between the multiple folded portions.

24. The embolic protective guidewire apparatus of claim 23, wherein the guidewire has an outer diameter between 0.014 and 0.035 inches.

25. The embolic protective guidewire apparatus of claim 23, wherein the guidewire lumen has a diameter between 0.010 and 0.025 inches.

26. The embolic protective guidewire apparatus of claim 23, wherein the inner wire has a diameter between 0.008 and 0.023 inches.

27. The embolic protective guidewire apparatus of claim 23, wherein the fdter has a diameter configured to extend to the vessel inner wall at said treatment site location.

28. An embolic protective guidewire apparatus for a patient’s vascular system having a vessel with a vessel lumen and an inner wall, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen, wherein the guidewire has a distal end and a proximal end, wherein said guidewire is configured to track through the patient’s vascular system distally of said sheath and to a selected treatment site location, and wherein said guidewire has a guidewire lumen; c) an inner wire that occupies the guidewire lumen, wherein in a first position, the inner wire is generally straight as defined by the guidewire lumen, and wherein in a second position, the inner wire is shaped such that the inner wire has an inner wire distal portion that extends beyond the distal end of the guidewire, and wherein in the second position, the inner wire distal portion has a memory that forms an embolic filter of multiple looped portions.

30. An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall, the guidewire having a distal end and a proximal end; c) said guidewire sized and shaped to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; d) said guidewire having a guidewire lumen; e) a filter wire that occupies the guidewire lumen in a storage position wherein the filter wire is, in the storage position, elongated and generally straight as defined by the guidewire lumen;

1) a deployed position of the filter wire that extends a filter wire distal portion beyond the distal end of the guidewire; and g) wherein in the deployed position, the filter wire distal portion has a memory that forms a filter with filter openings that enable blood flow through the filter openings while trapping emboli or debris that are too large to pass through the filter openings.

31. The embolic protection guidewire apparatus of claim 30, wherein the filter is a spiral having a diameter that extends to the vessel inner wall at said treatment site location.

32. The embolic protection guidewire apparatus of claim 30, wherein the filter is compressible when the filter is moved relative to the vessel inner wall.

33. The embolic protection guidewire apparatus of claim 31, wherein the spiral has a compressibility that enables the spiral to fit a range of vessel lumen diameters.

34. The embolic protection guidewire apparatus of claim 31, wherein the spiral has a tapered shape.

35. The embolic protection guidewire apparatus of claim 30, wherein the filter enables removal of filtered emboli by pulling of the filter into the introducer sheath.

36. The embolic protection guidewire apparatus of claim 30, further comprising a source of suction and wherein the filter enables removal of filtered emboli by application of a suction catheter or tube through the introducer sheath.

37. The embolic protection guidewire apparatus of claim 30, further comprising a suction catheter that enables aspiration of any emboli that are contained in the filter.

38. The embolic protection guidewire apparatus of claim 30, wherein the guidewire has a diameter of between 0.014 and 0.035 inches.

39. The embolic protection guidewire apparatus of claim 30, wherein the guidewire has a diameter of about 0.035 inches.

40. The embolic protection guidewire apparatus of claim 30, wherein the guidewire has an inner lumen diameter of between 0.010 and 0.025 inches.

41. The embolic protection guidewire apparatus of claim 30, wherein the fdter wire has a diameter of between 0.010 and 0.025 inches.

42. An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system, the guidewire having a distal end and a proximal end; c) wherein said guidewire is sized and shaped to track beyond the introducer sheath and into a patient’s vascular system and to a selected treatment site that is spaced away from the introducer sheath; d) said guidewire having a guidewire lumen; e) a filter that occupies the guidewire lumen in a first position wherein the filter has a shape that is defined by the shape of the guidewire lumen;

43. The embolic protection guidewire apparatus of claim 42, wherein the guidewire enables access to a selected treatment site wherein the filter remains contained within the guidewire lumen in a storage position.

44. The embolic protection guidewire apparatus of claim 42, wherein the guidewire has an atraumatic distal tip and wherein the guidewire lumen extends to said distal tip.

45. The embolic protection guidewire apparatus of claim 42, wherein the filter includes multiple loops.

46. The embolic protection guidewire apparatus of claim 45, wherein there is a distance between the loops between 0.01 and 1.0 mm.

47. The embolic protection guidewire apparatus of claim 45, wherein at least some of the loops are of differing diameters.

48. The embolic protection guidewire apparatus of claim 42, wherein the fdter is tapered distally.

49. The embolic protection guidewire apparatus of claim 42, wherein the fdter distal portion has an irregular wire shape that includes multiple folded portions.

50. The embolic protection guidewire apparatus of claim 42 wherein the fdter has an outer diameter that matches the diameter of a vessel wall.

51. An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a treatment site; c) said guidewire sized and shaped to track through the patient’s vascular system and to the treatment site; d) said guidewire having a guide wire lumen and distal and proximal ends; e) a fdter that occupies the guidewire lumen in a first position wherein the fdter is elongated and generally straight as defined by the guidewire lumen;

1) a second position of the fdter that extends a fdter distal portion beyond the distal end of the guidewire; and g) wherein the second position, the fdter includes a portion that expands to form a fdter structure with a diameter that approximates the vessel diameter.

52. An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall; c) said guidewire sized and shaped to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; d) said guidewire having a guidewire lumen; e) an inner wire that occupies the guidewire lumen in a first position wherein the inner wire is generally straight as defined by the guidewire lumen;

1) a second position of the inner wire that extends an inner wire distal portion beyond the distal end of the guidewire; and g) wherein in the second position, the inner wire distal portion has a memory that forms a filter having multiple folded portions and filter openings in between the folded portions.

53. The embolic protective guidewire apparatus of claim 52, wherein the guidewire has an outer diameter between 0.014 and 0.035 inches.

54. The embolic protective guidewire apparatus of claim 52, wherein the guidewire lumen has a diameter between 0.010 and 0.025 inches.

55. The embolic protective guidewire apparatus of claim 52, wherein the inner wire has a diameter between 0.008 and 0.023 inches.

56. The embolic protective guidewire apparatus of claim 52, wherein the filter has a diameter that matches the diameter of the vessel inner wall at said treatment site location.

57. An embolic protective guidewire apparatus, comprising: a) an introducer sheath having a sheath lumen; b) a guidewire configured to extend through said introducer sheath lumen and into a patient’s vascular system having a vessel with a vessel lumen and an inner wall, the guidewire having a distal end and a proximal end; c) said guidewire sized and shaped to track through the patient’s vascular system distally of said sheath and to a selected treatment site location; d) said guidewire having a guidewire lumen; e) an inner wire that occupies the guidewire lumen in a first position wherein the inner wire is generally straight as defined by the guidewire lumen;

1) a second position of the inner wire that extends an inner wire distal portion beyond the distal end of the guidewire; and g) wherein in the second position, the inner wire distal portion has a memory that forms an embolic filter of multiple looped portions.

58. A guidewire apparatus, comprising: a) an outer wire having an inner lumen, said outer wire sized and shaped to be guided through a selected portion of a patient’s vascular system; b) an inner wire movably mounted in said outer wire lumen between a stored position wherein said inner wire has a shape that assumes the shape of the outer wire lumen; c) the inner wire having a deployed position that positions a part of the inner wire distally of the outer wire inner lumen; d) wherein the inner wire has a memory that forms a generally conically shaped fdter in said deployed position; and e) wherein the fdter includes a randomly shaped portion having multiple irregular folds or loops.