WO2008039684A2

WO2008039684A2 - Embolic filter device and related systems and methods

Info

Publication number: WO2008039684A2
Application number: PCT/US2007/079011
Authority: WO
Inventors: James C. Peacock
Original assignee: Peacock James C
Priority date: 2006-09-20
Filing date: 2007-09-20
Publication date: 2008-04-03
Also published as: WO2008039684A3

Abstract

An adjustable lock is provided for primary use in over the wire medical systems and tracks over a guidewire to a location in a patient's body where it is locked onto the guidewire to form an integrated combination assembly with the guidewire in situ The lock includes a wire filament formed in a pattern as a quasi-tubular wall structure that circumscribes a guidewire passageway or bore The undulating pattern includes alternating adjacent opposite facing circumferentially oriented peaks that may be spread apart for a radially expanded and open condition of increased diameter that is retained by a retainer positioned within the lock or between the spread apart opposite facing peaks Removal of the retainer allows recovery of the lock inward to lock onto the guidewire Vanous retention assemblies and delivery systems are provided for use with the lock and associated device such as filter assembly.

Description

EMBOLIC FILTER DEVICE AND RELATED SYSTEMS AND METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US. Provisional Patent Application Serial No. 60/846,199, filed on September 20, 2006, incorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

OR DEVELOPMENT [0002] Not Applicable

INCORPORATION-BY-REFERENCE OF MATERIAL

SUBMITTED ON A COMPACT DISC [0003] Not Applicable

NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION [0004] A portion of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C. F. R. § 1.14.

BACKGROUND OF THE INVENTION 1. Field of the Invention

[0005] The present invention is a system and method for coupling one medical device with a second medical device at a location in the body. More specifically, it is an embolic filter system and method adapted for adjustable use over an indwelling guidewire for filtering emboli from blood flowing through a blood vessel in a patient. 2. Description of Related Art

[0006] Several embolic filter technologies have been disclosed for filtering emboli released during interventional procedures. One particular circumstance where embolic filtering has been investigated is for distal protection against emboli flowing toward the brain during carotid artery interventions, such as endarterectomy, angioplasty, stenting, or atherectomy or rotational ablation. Another circumstance under investigation is filtering distal run off of emboli during recanalization of grafts, such as coronary bypass grafts.

[0007] In general, distal embolic protection systems and methods provide a filter pre-disposed on a distal end portion of a guidewire chassis. The guidewire and filter are typically positioned translumenally through and across the intervention site in an antegrade fashion so that the filter is positioned downstream from the occlusion to be recanalized. Then the filter is deployed, generally as an expanded cage or porous material that allows blood to pass but for emboli of a predetermined size (according to the passage ports, e.g., through pores or other openings in the filter). The intervention upstream from the filter releases emboli that flow downstream into the deployed filter where they are caught. After the intervention is complete, a mechanism is provided that allows the filter to be adjusted for withdrawal, including capturing the emboli caught.

[0008] Notwithstanding great advances that have been made in recent years for providing distal embolic protection during vascular interventions, existing systems and methods still present many shortcomings, and many significant needs still remain for improved embolic filtering systems and methods.

[0009] For example, certain prior disclosures provide for a filter to be delivered over a guidewire with a stop on its distal end and then deploy the filter to "float" over the guidewire proximally to the stop. While this allows for some limited guidewire movement relative to the filter, proximal withdrawal of the guidewire engages the filter with the stop and allows for removal of the filter into a retrieval sheath. In other prior disclosures, a locking filter assembly is provided that is intended to be delivered over a guidewire via a guidewire tracking member associated with the filter, and then locked onto the guidewire. Once locked onto the guidewire, the combination assembly may also be retrieved into a delivery sheath by manipulating the guidewire. According to this approach, the locking mechanism and how it is actuated may affect the overall ease of manufacture and use, the ability to achieve robust delivery over the guidewire, actuation of the lock, and locking onto the guidewire with sufficient force to prevent undesirable uncoupling of the devices during manipulation of the system in situ.

[0010] In this latter regard, various medical systems and procedures, including and in addition to embolic protection and filtering systems and procedures, may benefit from an ability to lock one device onto a second device, such as in particular onto guidewires, for integral use at various locations in the body.

[0011] Various needs still exist in clinical medicine for improved embolic filtering systems, including without limitation the following needs. [0012] A need still exists for an improved locking mechanism that may combined with an interventional medical device assembly in a manner that can be remotely actuated from a location outside the body to lock the interventional medical device assembly onto another medical device, such as a delivery device or guide member, at a desired location within the body. This need still exists in particular for locking over-the-wire or "rapid exchange" type devices onto guide members such as guidewires at desired locations in the body, in particular but without limitation in percutaneous translumenal procedures.

[0013] A need also still exists for an improved embolic filter system that provides the ability to filter emboli during a guidewire-based medical procedure, but without requiring the guidewire itself to carry an integrated filter upon it during delivery of the guidewire to a filtering location in the body. [0014] A need also still exists for a filter assembly that can be advanced over a separate guidewire, and efficiently and reliably lock onto the guidewire to thereby form in situ a filter wire with the locked combination of filter and wire.

[0015] A need also still exists for an adjustable lockable filter assembly that can track over a guidewire and lock onto the guidewire in situ, but that can be manufactured relatively efficiently and at relatively low cost.

[0016] A need also still exists for an adjustable lockable filter assembly that can track over a guidewire and lock onto the guidewire in situ, and that is manufactured with relatively few parts or joints between parts. [0017] A need also still exists for an adjustable lockable filter assembly that includes an adjustable lock assembly with a substantially tubular structure that provides an improved ability to be radially expanded in an open condition, loaded onto a retainer that holds it in the expanded and open condition for tracking over a guidewire, and to be efficiently released from the retainer by actuation from user at a remote location externally of the patient to recover to a collapsed memory condition that locks onto the guidewire. This need exists in particular but without limitation with respect to a locking assembly to be loaded and retained over an adjustable inner sheath that holds the tubular structure to a radially expanded and open condition for tracking over a guidewire, and to be released by retraction of the inner sheath for elastic or superelastic recovery toward a memory shape and radially closed diameter, whereby the force of material recovery thereby locks the tubular structure onto the guidewire with substantial force.

[0018] A need also still exists for an improved ability to filter emboli released or caused during procedures involving specialty guidewires that are coupled to actuators and intended for performing specialized guidewire procedures other than filtering. A particular need exists for an adjustable lockable filter assembly that is provided or used in combination with an actuated chronic total occlusion crossing system for filtering emboli associated with chronic total occlusion interventions. BRIEF SUMMARY OF THE INVENTION [0019] Various aspects of the present disclosure are provided as solutions that meet the various needs just described.

[0020] One aspect of the present disclosure is an adjustable lock that may be delivered in one configuration to a location over a rail or guide member, and that is adjustable at the location to lock onto the rail or guide member for integral and coordinated use between them thereafter.

[0021] Another aspect of the present disclosure is an embolic filter system that diverts captured debris in a body lumen at least partially away from relatively higher flow portions of the lumen.

[0022] Another aspect of the present disclosure is a system for filtering emboli from fluid at a location within a lumen in a patient's body that includes an embolic filter module with an adjustable guidewire lock assembly and an adjustable filter assembly. The adjustable guidewire lock assembly comprises a substantially tubular wall comprising an undulating pattern of shape memory strut material with an alternating series of opposite facing partial loop-shaped peaks along a length along a longitudinal axis and which peaks respectively face in alternating opposite directions transverse to the longitudinal axis. The substantially tubular wall defines an inner diameter around a guidewire passageway.

[0023] According to one mode of this aspect, upon applied forces in opposite directions, the adjacent peaks may be spread apart relative to each other so as to expand the inner diameter at the location of the adjacent opposite peaks.

[0024] According to another mode, the filter module comprises an integral piece of material in a patterned shape along the lock assembly and filter assembly. [0025] According to another mode, the substantially tubular wall comprises a nickel-titanium alloy tube material cut in the pattern.

[0026] In one embodiment of this mode, the patterned shape is cut from a nickel-titanium alloy tube. [0027] According to another embodiment, the patterned shape comprises the pattern of strut material along the lock assembly and a loop-shape filter support member along the filter assembly.

[0028] In another embodiment, the patterned shape comprises a lever arm extending between the lock assembly and the loop-shaped filter support member.

[0029] In still another embodiment, the patterned shape comprises the pattern of strut material along the lock assembly and a lantern-shape filter support member with a series of circumferentially spaced longitudinal splines along the filter assembly.

[0030] Another aspect of the present disclosure is a system for filtering emboli from fluid at a location within a lumen in a patient's body with a filter assembly with an adjustable filter wall that is adjustable between a radially collapsed configuration and a radially extended configuration as follows. In the radially collapsed configuration, the filter wall has a first outer diameter and is adapted to be delivered to the location. In the radially extended configuration the filter wall has a second outer diameter that is greater than the first outer diameter and sufficient to substantially span across a cross-sectional area of the lumen at the location and engage a wall of the lumen, and has a shape that forms a pouch adjacent an outer periphery of the area and to substantially divert emboli encountered by the wall to the outer peripheral pouch.

[0031] According to one mode of this aspect, the pouch is substantially annular around an outer circumferential region of the area and substantially surrounds an inner region of the wall that forms an inverted cone shape with a reducing taper diameter in the retrograde direction of fluid flow.

[0032] According to one embodiment of this mode, the filter support scaffold comprises a loop shaped member coupled to the wall along the outer periphery, and the inverted cone shaped region is substantially fixed relative to the loop shaped member in the radially extended condition at the location. [0033] In another mode, the filter assembly is deliverable over a guidewire by a delivery assembly to a position along the guidewire at the location. [0034] According to one embodiment of this mode, the filter assembly is detachable from the delivery assembly at the position. In one further embodiment, the filter assembly comprises an adjustable guideiwire lock assembly and is lockable at the position onto the guidewire at the location. In a still further embodiment, a guidewire is provided with a radial enlargement on a distal end portion thereof, wherein the filter position is proximally of the enlargement, and the filter assembly is configured to float freely of the guidewire at the position, provided that upon proximal withdrawal of the guidewire relative to the filter assembly the enlargement mechanically confronts the filter assembly such that they may be thereafter withdrawn together upon further withdrawal force placed upon the guidewire. [0035] Another aspect of the present disclosure provides a system for filtering emboli from fluid at a location within a lumen in a patient's body with an embolic filter module with an adjustable guidewire lock assembly and an adjustable filter assembly. The adjustable guidewire lock assembly includes a substantially tubular or quasi-tubular wall around a bore that extends along a longitudinal axis between two opposite open ends, and with a continual lateral passageway through the wall and extending between the two ends and that is bordered by first and second sides of the wall. The wall comprises an elastic or superelastic material with a memory state in the radially collapsed and closed condition with a first inner diameter across the bore, and is deformable under an applied force to a radially expanded and open condition with a second inner diameter across the bore that is larger than the first inner diameter. The bore comprises a guidewire passageway. [0036] In one mode of this aspect, the first and second sides each comprises a port or aperture through the wall, or a wire filament structure.

[0037] In another mode, the lateral passageway in the radially collapsed and closed condition comprises a patterned shape along the wall and that does not include a straight linear pathway between the first and second ends. [0038] In one embodiment, the patterned shape comprises an undulating pattern with a series of alternating opposite facing peaks that face each other transverse to the longitudinal axis.

[0039] In another embodiment, the lateral passageway in the radially expanded and open condition comprises a straight linear pathway extending between the first and second ends and with a minimum diameter D between the first and second sides.

[0040] According to another mode, the system further includes an adjustable retainer that is adjustable between first and second positions relative to the lock and corresponding with the radially expanded and open condition and the radially collapsed and closed condition for the lock, respectively. The first position is located within either the bore or the lateral passageway and is configured to retain the lock in the radially expanded and open condition. The second position is located outside of each of the bore and the lateral passageway. The retainer is adjustable from the first position to the second position by moving the retainer relative to the lock via a remotely manipulated actuator. By adjusting the retainer from the first position to the second position the lock is released from retention in the radially expanded and open condition and allowed to recover under elastic or superelastic material recovery force toward a memory condition and to the radially collapsed and closed condition. [0041] In one embodiment of this mode, the retainer is adjustable from the first position to the second position by proximal withdrawal of the retainer along the longitudinal axis relative to a mechanical interference against a proximal withdrawal of the lock.

[0042] In another embodiment, the retainer comprises an inner retainer tube with an elongated tubular wall with an outer surface and inner passageway that is located at least in part along the bore in the first position. The lock is retained in the radially expanded and open condition outside and at least partially around the outer surface in the first position for the retainer. In a further embodiment, the lock is seated on the outer surface of the tubular wall in the first position with an inward force of material recovery toward a memory condition from the elastically or superelastically deformed material in the radially expanded and open condition. In a still further embodiment, the retainer comprises a stand-off from the outer surface that is located within the lateral passageway and with first and second edges in confronting engagement with the first and second sides of the lock's wall in the first position.

[0043] According to another embodiment, the retainer is located within the lateral passageway and comprises first and second edges in confronting engagement with the first and second sides of the lock's wall in the first position, such that the retainer provides a mechanical interference against the first and second sides recovering toward each other in the elastically or superelastically deformed radially expanded and open condition. [0044] In one further embodiment, the retainer comprises an interior stand-off from an outer tubular member that in the first position is located externally around the lock in the open condition but for the retainer located in the lateral passageway. In another further embodiment, the retainer comprises at least one recessed groove within one of the retainer's edges that is configured to receive a teast a portion of a corresponding side of the lock's wall for enhanced retention of the lock in the open condition.

[0045] According to still a further mode of the various aspects just described above, a dynamic coupler is located between the filter assembly and the lock and providing for a limited range of motion between the filter assembly when deployed within a lumen for filtering and the lock when locked onto a guidewire in the lumen.

[0046] In one embodiment of this mode, the dynamic coupler comprises a tether, thread, or filament. In another embodiment, the dynamic coupler comprises a spring. In another embodiment, the dynamic coupler is formed integrally with the lock and a filter support member of the filter assembly from one piece of material. In one further embodiment, the piece of material comprises a wire filament wound into a pattern. In another further embodiment, the piece of material comprises an elastic or superelastic tube. [0047] In another embodiment, at least one of the lock, filter assembly, and dynamic coupler comprises a separate part secured to another of the lock, filter, and dynamic coupler.

[0048] According to another mode of the various adjustable filter module aspects of the disclosure, the lock and the filter assembly are formed integrally with each other from one piece of material. In another mode, the lock and the filter assembly are separate parts coupled together. In another mode, a delivery system is configured to deliver the lock and filter assembly to a location over a guidewire in a body of a patient. [0049] In another mode of the various aspects, a guidewire is provided that is configured to provide a rail for delivering the filter assembly to a location in a body of a patient. In another mode, an interventional device system is provided that is configured to perform an intervention adjacent to the filter assembly in a body of a patient. [0050] Another aspect is a system for releasably adjusting a radially adjustable tubular or quasi-tubular lock between a radially collapsed and closed memory condition with a first inner diameter and a superelastically or elastically deformed radially expanded and open condition with a larger second inner diameter. This system includes an adjustable lock with a tubular or quasi- tubular wall around a bore that extends along a longitudinal axis between two opposite open ends, and with a continual lateral passageway through the wall and extending between the two ends and that is bordered by first and second sides of the wall. The wall comprises an elastic or superelastic material with a memory state in the radially collapsed and closed condition with the first inner diameter across the bore, and is deformable under an applied force to a radially expanded and open condition with a larger second diameter across the bore. An expansion assembly is also provided with at least first and second adjustable pull members. The first pull member is configured to releasably engage the first side. The second pull member is configured to releasably engage the second side. The first and second pull members are configured to transmit a pull force under tension to the respectively engaged first and second sides sufficiently to spread the first and second sides apart to thereby expand a distance therebetween to broaden the lateral passageway and deform the wall into the radially expanded and open condition with the larger second diameter across the bore. The first and second pull members are configured to release the first and second sides, respectively, in the radially expanded and open condition to allow the lock to recover under elastic or superelastic memory recovery force to the radially collapsed and closed condition.

[0051] According to one further mode of this aspect, a retainer assembly is also provided with a retainer that is adjustable between first and second positions relative to the lock at a location. The first position is located within at least one of the bore and the lateral passageway and retains the lock substantially in the open condition; and the second position is located outside of the bore and lateral passageway of the lock's wall. The retainer is adjustable to the first position while the lock's wall is adjusted to the radially expanded and open condition by the expansion assembly. The retainer in the first position is configured to retain the lock in the radially expanded and open condition after it is released by the expansion assembly. The retainer is adjustable from the first position to the second position relative to the lock by providing moving the retainer relative to the lock via an actuator.

[0052] In another mode, a third pull member is provided, in addition to at least two locations on the first side of the lock's wall bordering the lateral passageway and configured to be engaged by each of the first and third pull members. The first and third pull members are configured to engage the two locations for pulling the first side apart under applied tension from the second side engaged and pulled by the second pull member.

[0053] In one embodiment of this mode, the first and third pull members are coupled to a fixture providing coordinated positioning and movement between them. In one further embodiment, he first and third pull members comprise extensions from a common piece of material. [0054] In another embodiment, at least a fourth pull member is also provided, in addition to at least two locations on the second side of the lock bordering the lateral passageway and configured to be engaged by each of the second and fourth pull members. The first and third pull members are configured to engage the two locations on the first side for pulling the first side away from the lateral passageway. The second and fourth pull members are configured to engage the two locations on the second side for pulling the second side away from the lateral passageway. In one further embodiment, the first and third pull members are coupled to a fixture providing coordinated positioning and movement between them, and the second and fourth pull members are coupled to a fixture providing coordinated positioning and movement between them. In another further embodiment, the first and third pull members comprise extensions from a first common piece of material; and the second and fourth pull members comprise extensions from a second common piece of material.

[0055] In another mode of the present aspect, the first and second pull members are coupled to a fixture to provide coordinated movement between them for pulling with tension on the respectively engaged lock wall. [0056] In still another mode, each respective pull member comprises a tether, wire, thread, or filament configured to loop around an aperture, wire filament, or other feature provided along the respective side of the lock's wall. [0057] In yet another mode, each respective pull member comprises a tension member with a hook configured to engage a mating location along the respective side of the lock's wall. In one embodiment of this mode, the hook comprises a feature to at least partially enclose a portion of the wall engaged by the hook.

[0058] Further to the modes providing at least three pull members, one further embodiment provides that at least the first side of the lock comprises two locations of predetermined relative positions for engagement with the first and third pull members. The first and third pull members are provided in a fixture at two locations of predetermined relative positions between them and corresponding with the positions of the two locations for coordinated engagement with the first and third pull members. In one further embodiment, he fixture is configured to pull the first and third pull members laterally. In another, the fixture is configured to pull the first and third pull members along an arcuate path.

[0059] Another aspect of the present disclosure is a method for releasably adjusting a radially adjustable tubular or quasi-tubular lock between a radially collapsed and closed memory condition with a first inner diameter and a superelastically or elastically deformed radially expanded and open condition with a larger second inner diameter. This method includes providing an adjustable lock with a tubular or quasi-tubular wall around a bore that extends along a longitudinal axis between two opposite open ends, and with a continual lateral passageway through the wall and extending between the two ends and that is bordered by first and second sides of the wall. Further to this method, the wall comprises an elastic or superelastic material with a memory state in the radially collapsed and closed condition with the first inner diameter across the bore, and is deformable under an applied force to a radially expanded and open condition with a larger second diameter across the bore. The method thus further includes providing an expansion assembly with at least first and second adjustable pull members; releasably engaging a first side of the lock's wall with the first pull member; releasably engaging the second side of the lock's wall with second pull member; and applying tension to the first and second pull members in a manner that transmits a pull force to the respectively engaged first and second sides sufficiently to spread the first and second sides apart to thereby expand a distance therebetween to broaden the lateral passageway and deform the wall into the radially expanded and open condition with the larger second diameter across the bore.

[0060] In one further mode, the method also includes releasing the first and second pull members from the first and second sides, respectively, in the radially expanded and open condition to allow the lock to recover under elastic or superelastic recovery force to the radially collapsed and closed condition. [0061] One embodiment includes: providing a retainer assembly with a retainer that is adjustable between first and second positions relative to the lock; wherein the first position is located within at least one of the bore and the lateral passageway and retains the lock substantially in the open condition; wherein the second position is located outside of the bore and lateral passageway of the lock's wall; positioning the retainer in the first position while the lock's wall is adjusted to the radially expanded and open condition by the expansion assembly; releasing the first and second pull members from the first and second sides of the lock's wall while the retainer is located in the first position; retaining the lock in the radially expanded and open condition with the retainer in the first position after the lock is released by the expansion assembly; and adjusting the retainer from the first position to the second position relative to the lock by moving the retainer relative to the lock via an actuator, thereby releasing the lock from retention in the radially expanded and open condition and allowing it to recover with elastic or superelastic memory recovery force to the radially collapsed and closed condition.

[0062] A further embodiment includes: providing at least a third pull member; engaging at least two locations along the first side of the lock's wall bordering the lateral passageway by each of the first and third pull members; and applying tension to the first and third pull members to pull the first side apart from the second side engaged and pulled by the second pull member. A still further embodiment includes coordinating relative positioning and movement between the first and third pull members via a fixture. Yet another further embodiment includes providing the first and third pull members as extensions from a common piece of material. Still further, the method may also include: providing at least a fourth pull member; engaging at least two locations along the second side of the lock's wall bordering the lateral passageway by each of the second and fourth pull members; applying tension to the first and third pull members engaged with the two locations on the first side to pull the first side away from the lateral passageway; and applying tension to the second and fourth pull members engaged with the two locations on the second side to pull the second side away from the lateral passageway. In a further variation the method also includes coordinating relative positioning and movement between the first and third pull members with a fixture; and coordinating relative positioning and movement between the second and fourth pull members with a fixture. This may further include providing and manipulating the first and third pull members as extensions from a first common piece of material; and providing and manipulating the second and fourth pull members as extensions from a second common piece of material.

[0063] In another mode of the broad method aspects herein disclosed, such methods may further include coupling the first and second pull members to a fixture; and providing coordinated movement between the first and second pull members to pull with tension on the respectively engaged lock wall.

[0064] Another mode comprising looping the pull member that comprises a tether, thread, or wire filament through an aperture, wire filament, or other feature along the respective lock wall.

[0065] Another method mode comprises hooking an aperture, wire filament, or other feature along the respective lock wall with a pull member that comprises a hook on an end of a tension member. [0066] An embodiment of various modes presented also includes securing a first end of the pull member looped or hooked through the aperture, wire filament, or other feature along the respective wall relative to a second end extending from the feature prior to pulling on the wall. Other embodiments include providing the first side of the lock wall with at least two locations of predetermined relative positions for engagement with the first and third pull members; and providing the first and third pull members in a fixture at two locations of predetermined relative positions between them and corresponding with the positions of the two locations for coordinated engagement with the first and third pull members. A further embodiment to this includes pulling the first and third pull members laterally relative to the lock with the fixture; another includes pulling the first and third pull members along an arcuate path relative to the lock with the fixture. [0067] Another aspect of this disclosure provides a method for providing an adjustable lock in a delivery system for delivering the lock over a guide member to a location in a patient's body and locking the lock onto the guide member at the location. This includes providing the lock with an elastic or superelastic tubular or quasi tubular wall structure around a bore that extends along a longitudinal axis between two open ends and with a continuous lateral passageway through the wall between the first and second ends and with first and second sides of the wall bordering the lateral passageway, wherein the wall is adjustable between a radially collapsed and closed condition and an elastically or superelastically deformed radially expanded and open condition.

The lock is adjusted to the radially expanded and open condition by spreading the first and second sides of the wall apart relative to the passageway. An adjustable retainer is positioned in a first position within at least one of the bore or the lateral passageway while the lock is in the radially expanded and open condition. The lock is retained in the radially expanded and open condition by the retainer, and is configured to slideably engage a guide member through the bore and track over the guide member to the location with the retainer in the first position. The retainer is adjustable at the location from the first position to a second position that is outside of the bore and lateral passageway to thereby release the lock for recovery toward the radially expanded and closed condition for locking engagement over the guide member at the location.

[0068] Another aspect is a method for delivering an adjustable lock in a delivery system over a guide member to a location in a patient's body and for locking the lock onto the guide member at the location. This method provides a lock with an elastic or superelastic tubular or quasi tubular wall structure around a bore that extends along a longitudinal axis between two open ends and with a continuous lateral passageway through the wall between the first and second ends, and with an adjustable retainer located in a first position within at least one of the bore or the lateral passageway to thereby retain the lock in a radially expanded and open condition with a first inner diameter across the bore. A guide member is slideably engaged through the bore and allowing for tracking the lock and retainer assembly over the guide member to the location with the retainer in the first position. The retainer is adjusted at the location from the first position to a second position that is outside of the bore and lateral passageway, thereby releasing the lock from retention and allowing the lock to recover under elastic or superelastic material memory recovery force toward the radially collapsed and closed condition and that locks the lock over the guide member at the location.

[0069] According to the various system aspects herein described, it is to be appreciated that in further modes at least one of the following additional components or devices are further provided as additional modes hereunder: a guidewire; an atherectomy device, a balloon catheter; a stent; a delivery catheter; an introducer sheath.

[0070] The various aspects, modes, embodiments, variations, and features just described are to be considered independently beneficial without requiring limitation by the others. However, further combinations and sub-combinations between them as may be apparent to one of ordinary skill are also contemplated as further aspects hereunder. Other beneficial aspects, modes, and embodiments are to be appreciated by one of ordinary skill based upon further review of the disclosure below, appended claims, and accompanying

Figures.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS

OF THE DRAWING(S) [0071] The invention will be more fully understood by reference to the following drawings which, though variously demonstrating certain highly beneficial embodiments of the present invention considered of independent value, are also provided for illustrative purposes with respect to the broad aspects of the invention and are not intended to necessarily limit those broad aspects except where indicated as such. [0072] FIG. 1 shows a top view of one embodiment for an adjustable guidewire lock according to the present disclosure. [0073] FIG. 2 shows a top view of one embodiment for making an adjustable guidewire lock similar to that shown in FIG. 1 .

[0074] FIG. 3 shows a top view of another alternative embodiment for making an adjustable guidewire lock similar to that shown in FIG. 1 . [0075] FIG. 4 shows an exploded cross-section of a portion of another alternative embodiment for making an adjustable guidewire lock similar to that shown in FIG. 1 .

[0076] FIGS. 5A-B show top views of two respective conditions, radially collapsed (or closed) and radially expanded (or open), for an adjustable guidewire lock similar to that shown in FIG. 1 .

[0077] FIGS. 6A-B show a top view of an adjustable guidewire lock, similar to that shown in FIG. 1 , held in a radially expanded and open condition similar to that shown in FIG. 5B according to one retainer embodiment of the present disclosure that includes an adjustable inner retainer tube, and with a guidewire shown slideably engaged within an inner guidewire passageway or lumen of the inner retainer tube in FIG. 6B.

[0078] FIG. 7 shows a top view of an adjustable guidewire lock, similar to that shown in FIG. 1 , held in a radially expanded and open condition similar to that shown in FIG. 5B according to another retainer embodiment of the present disclosure.

[0079] FIG. 8 shows a cross-sectioned view of another retainer embodiment for use in retaining an adjustable guidewire lock in a radially expanded and open condition according to the embodiment shown in FIG. 7, with a portion of the adjustable guidewire lock shown held open by the retainer in the radially expanded and open condition.

[0080] FIG. 9 shows a cross-sectioned view of another retainer embodiment for use in retaining an adjustable guidewire lock in a radially expanded and open condition according to the embodiment shown in FIG. 7, with a portion of the adjustable guidewire lock shown held open by the retainer in the radially expanded and open condition. [0081] FIG. 10 shows a cross-sectioned view of another retainer embodiment for use in retaining an adjustable guidewire lock in a radially expanded and open condition according to the embodiment shown in FIG. 7.

[0082] FIG. 1 1 shows a cross-sectioned view of another retainer embodiment for use in retaining an adjustable guidewire lock in a radially expanded and open condition according to the embodiment shown in FIG. 7.

[0083] FIG. 12 shows a top view of the assembly of the adjustable guidewire lock and retainer portion shown in FIG. 7 during another mode of use after the guidewire lock is released by proximal withdrawal of the retainer, relative to the guidewire lock, such that the adjustable guidewire lock is allowed to adjust to a radially collapsed and closed condition by memory recovery of the elastic or superelastic material forming the filamental structure of the lock.

[0084] FIG. 13 shows a cross-sectioned view of the retainer shown in FIG. 8 in combination with one actuator embodiment of the present disclosure that is fit around the retainer in a configuration that provides a mechanical stop against the lock held open by the retainer, such that upon proximal withdrawal of the retainer relative to the actuator the lock is prevented from proximal withdrawal with the retainer and is thereby released from the retainer.

[0085] FIG. 14 shows a cross-sectioned view of the retainer shown in FIG. 9 in combination with another actuator embodiment of the present disclosure that is fit around the retainer in a configuration that provides a mechanical stop against the lock held open by the retainer, such that upon proximal withdrawal of the retainer relative to the actuator the lock is prevented from proximal withdrawal with the retainer and is thereby released from the retainer. [0086] FIG. 15 shows a top view of an assembly of a lock and retainer, and slideably engaged guidewire, similar to the embodiment shown in FIG. 6B, but including in further combination with another actuator embodiment of the present disclosure.

[0087] FIG. 16 shows a top view of an assembly of a lock and retainer, and slidably engaged guidewire, also similar to the embodiment shown in FIG. 6B, but including in further combination with still another actuator embodiment of the present disclosure shown in longitudinal cross-section. [0088] FIG. 17A shows an angular perspective view of another adjustable lock embodiment of the present disclosure.

[0089] FIG. 17B shows a top view of an adjustable lock similar to the embodiment shown in FIG. 17A.

[0090] FIG. 17C shows a transverse cross-sectioned view taken along lines

17C-17C in FIG. 17B. [0091] FIG. 18 shows a top view of another adjustable lock embodiment of the present disclosure. [0092] FIGS. 19A-B show one expansion fixture embodiment in two modes of use for expanding a lock similar to that shown in FIG. 1 from a radially collapsed and closed memory condition with a first diameter, shown in FIG.

19A, to a radially expanded and open deformed condition with a larger second diameter, shown in FIG. 19B. [0093] FIGS. 19C-D show another expansion fixture embodiment in two modes of use for expanding a lock similar to that shown in FIG. 1 from a radially collapsed and closed memory condition with a first diameter, shown in

FIG. 19C, to a radially expanded and open deformed condition with a larger second diameter, shown in FIG. 19D. [0094] FIGS. 19E-F show top and cross-sectioned side views, respectively, of another expansion fixture embodiment for expanding a lock similar to that shown in FIG. 1 from a radially collapsed and closed memory condition with a first diameter to a radially expanded and open deformed condition with a larger second diameter. [0095] FIG. 2OA shows a side view of a tube in a first condition corresponding with a first mode of manufacturing an integral scaffold for use in supporting and delivering an adjustable filter module over a guidewire, and locking the scaffold of the module onto the guidewire, in situ.

[0096] FIG. 2OB shows a side view of the tube shown in FIG. 2OA in a second condition corresponding with a second mode of manufacturing the integral scaffold wherein the tube is cut into a patterned filamental scaffold assembly in a substantially tubular shape with an open filamental wall surrounding a bore.

[0097] FIG. 2OC shows a side view of an embolic filter assembly that includes the patterned scaffold assembly shown in FIGS. 20A-B in a third condition corresponding with a third mode of manufacturing the integral lockable scaffold, and that also includes a filter membrane coupled to the integral scaffold.

[0098] FIG. 21 shows a longitudinally cross-sectioned side view of another adjustable filter module within a particularly beneficial delivery assembly incorporating a retainer and actuator assembly similar to that shown in FIG. 16 over a guidewire.

[0099] FIG. 22 shows a two-dimensional CAD drawing of a pattern for laser cutting a tube according to another integral scaffold embodiment of the present disclosure providing an adjustable lock and filter scaffold from one integral piece of material. [00100] FIG. 23 shows a picture of an adjustable filter module constructed by securing a membrane representing a filter membrane to a filter support scaffold of an integral scaffold cut from a tube according to a similar pattern to that shown in FIG. 22, and shows the integral lock in the closed and locked condition locked onto a commercially available 0.014" guidewire. [00101] FIGS. 24A-C show side views of another embolic filter module in first, second, and third configurations, respectively, that correspond with first, second, and third modes of use, also respectively, when locked onto a guidewire in situ, and also incorporating a dynamic coupler between the lock and the filter assembly of an integral scaffold according to a further embodiment of the disclosure.

[00102] FIG. 25 shows a top view of an integral scaffold for use in an adjustable filter module similar to that shown in FIGS. 24A-C, and includes a lock, a filter support scaffold, and a dynamic coupler therebetween. [00103] FIGS. 26A-G show various schematic side views of an adjustable embolic filter module during sequential modes of use in an overall system and method for treating a chronic total occlusion while providing distal embolic protection according to a further embodiment of the present disclosure. [00104] FIG. 27 shows another filter module embodiment providing an adjustable filter module similar to that shown in FIGS. 22-23, except according to a further filter membrane embodiment of the disclosure. DETAILED DESCRIPTION OF THE INVENTION

[00105] Referring more specifically to the drawings, the Figures 1 to 27 variously provide certain details of various beneficial embodiments illustrative of one or more aspects and modes herein contemplated. While each is considered independently beneficial, additional combinations and sub- combinations between the Figures are also contemplated.

[00106] FIG. 1 shows an adjustable guidewire lock 20 that is particularly well suited and intended for use in combination with other elements of a medical device in order to allow the device to be delivered over a guide member, such as a guidewire, and be locked onto that guide member in situ. More specifically, it is constructed to be held by a retainer in a radially expanded and open condition for delivery over a guidewire to a location in the body, then to be released from the retainer at the location such that the lock recovers by elastic or superelastic material memory toward a radially collapsed or closed condition that locks onto the guidewire under that elastic or superelastic recovery force. This is considered of particular benefit for combination systems and uses with embolic filter assemblies such as in particular in distal embolic protection systems and methods. While the present disclosure provides detailed descriptions of various embodiments for such an adjustable lock, such embodiments are generally considered useful principally when incorporated in such broader systems and methods, which may be employed in improved ways with various distinct benefits to overall patient care according to these present embodiments.

[00107] More specifically addressing certain features provided by lock 20 as shown in FIG. 1 , lock 20 includes a filamental structure 22 in an undulating pattern with opposite facing, circumferentially oriented, and longitudinally spaced peaks, such as shown for example at peaks 24,26, relative to a longitudinal axis. A substantially tubular (though partially open) wall is formed by the filamental structure 22 in this pattern that has a diameter D which surrounds a bore 23 extending between two opposite open ends 21 ,23. In addition, according to the filamental pattern shown, a continuous lateral passageway 28 is provided along the wall between the two open ends and between the undulating windings and opposite facing peaks of the filamental structure. The bore 23 communicates through the wall through this lateral passageway 28. As will be described in further detail below, this structure has been observed to provide particular benefits for loading the adjustable lock 20 onto a retainer in a radially expanded and open condition for delivery over a guidewire to a location within the body, and for releasing the lock from the retainer and locking with significant force onto the guidewire.

[00108] Various aspects of the specific embodiment shown in FIG. 1 are considered to provide particular benefit in certain contemplated uses as presently intended. However, other modes, embodiments, features, and variations of such an adjustable lock are contemplated within the broad aspects of the present disclosure, without requiring limitation to only those specific details of the embodiments shown and described as examples of such broad aspects. [00109] In one particular regard, an adjustable lock as just shown and described by reference to FIG. 1 may be made according to various approaches as would be apparent to one of ordinary skill. Certain particular embodiments for manufacturing the lock, however, are considered particularly beneficial and presented immediately below as examples. [00110] FIG. 2 shows one such embodiment for making an adjustable guidewire lock similar to that lock 20 shown in FIG. 1 as follows. A tube 30, such as for example a superelastic alloy hypotube, such as nickel-titanium, is used as a workpiece from which to form lock 20. More specifically, a pattern is cut into the tube 30, such as using a laser, to provide a continuous patterned filament 32 with a longitudinally spaced series of opposite facing circumferentially oriented peaks 34,36, relative to longitudinal axis L of the tube 30. In cutting the pattern in the tube in this manner, certain excess material 37 is removed.

The result provides the filamental pattern in a quasi-tubular structure that surrounds the bore 35, and extending between two open ends 31 ,33, of the original tube 30. This provides a similar structure as the finished lock shown in FIG. 1 , however subject to certain post-processing to follow the patterned laser cutting such as electropolishing, microblasting, and heat training the material into a desired memory shape if different from the "as cut" shape and dimensions from the original cut tube. ] FIG. 3 shows another approach for manufacturing a lock similar to lock 20 in FIG. 1. In this embodiment, a wire filament 40 is used to form the ultimate filamental tubular structure of the lock by winding it onto a fixture designed to provide the desired shape to be either the final memory condition for the filamental structure, or an interim condition in which the filamental material may set and then be retrained into the final memory condition desired. More specifically, the fixture includes a bar or mandrel 41 that includes a series of raised pegs 43,45. The wire filament 40 is wound around the mandrel 41 and looped around the alternating serial pegs 43,45 in opposite facing circumferentially oriented peaks 44,46, respectively, as shown. In this wound condition, the assembly is subjected to heat training using known techniques to heat set the memory of the wire filament 40 into the wound pattern on the fixture. Accordingly, the fixture is constructed from a material adapted to withstand such heat treatments without compromising its integrity or that of the wire filament 40 with which it is contacting. It is to be appreciated that the fixture shown is provided in general features and somewhat schematically, and various more specific features may be employed, or specific arrangement of component parts varied, without departing from the broad intended scope represented by way of example by the illustrative embodiment. For example, the alternating series of adjacent pegs 43,45 may be staggered with circumferential positions that are off-set relative to each other, to result in a customized degree of circumferential

"overlap" between the respective opposite facing peaks 44,46 of the wire filament 40 wound around them at the diameter provided by the fixture. Such customization of adjacent peak orientation or overlap may affect the overall ability to efficiently load and hold the filament on a retainer in a radially expanded and open condition at a diameter that is superelastically deformed from the trained pattern on the fixture, and to provide efficient locking on a guidewire at another particular diameter.

[00112] This is in addition to other features which may be varied to also produce different results in intended uses such as just described, including for example but without limitation: thickness (in radial axis) and/or width (in circumferential axis) of the wire filament, spacing between the adjacent peaks, angled pitch of the wire filament converging at the peaks, radius of the peak(s), and angled pitch of the peaks relative to the longitudinal bore, and specific properties of the material used for the wire filament.

[00113] FIG. 4 shows still another embodiment for making an adjustable guidewire lock similar to that shown in FIG. 1. Similar to the embodiment of

FIG. 3, a wire filament 52 is used to form the lock, and is formed and trained in a desired pattern, either as the final desired pattern or an intermediate pattern, using a fixture. However, rather than winding the wire filament 52 around pegs as in the FIG. 3 embodiment, the present embodiment submerges the wire filament 52 into a grooved pattern formed in a work piece, which may also be a mandrel or other material bar or tube chosen for properties able to hold the wire in the pattern and withstand the heat treatment to be given to the assembly. This grooved pattern may follow for example a similar pattern as shown in shadow for laser cutting the filament 32 in FIG. 2. However, in the present embodiment the pattern is a recessed groove as shown at recess 54 in cross-section through wall 56 in FIG. 4. A lip 58 may be provided that allows the wire 52 to be positioned within the groove 54 as shown, but to retain it there during the manipulation of loading the whole pattern and subsequent heat training. After heat training the wire 52 into a superelastic memory condition in the grooved pattern, the wire 52 is removed by simply pulling it out from the groove 54 such as by manipulating from an exposed piece of the wire 52 (that may be subsequently cut from the lock).

[00114] While the lock patterns shown and described are designed to provide beneficial functional features herein disclosed, it is also contemplated that certain mechanical challenges may be encountered during intended use at the ends of such structures. For example, a lock oriented to extend longitudinally in a proximal direction from an integrated or coupled filter assembly may terminate in a proximal end that is relatively exposed to mechanical interface as it rests on the guidewire. If engaged by another device, such as an angioplasty balloon or stent delivery system, or stent, it could be pulled up from the wire with potential adverse consequences. Or, it may have a relatively sharp feel to adjacent structures such as tissue as the exposed end of the locked assembly. Accordingly, various further embodiments hereunder contemplated providing custom features at such an end intended to enhance its performance and prevent such potential adverse results. For example, the terminal end of an undulating wound or cut filament pattern may be welded, soldered, adhesively bonded, or otherwise secured to the adjacent strut of the filament adjacent to the end. Or, it may terminate in an annular ring. In still another feature, it may be made stronger, such as give a wider dimension, may be given a rounded atraumatic terminal tip, jacketed in a polymer or other form of atraumatic cover or coating, or may be thinned in the radial plane to reduce the likelihood of confronting engagement or other adverse consequences of providing "stand-off at the end of a locked filter wire on a guidewire's outer surface.

[00115] As elsewhere herein described, the lock assemblies of the present embodiments are generally adjustable from a superelastic memory condition that is radially collapsed and a closed condition to a radially expanded and open condition wherein the filamental patterned tubular structure is superelastically deformed open to span a larger diameter bore. This is illustrated by way of further example by reference to FIGS. 5A-B and further reference to FIG. 1 as follows. [00116] To the extent FIG. 1 illustrates a lock 20 in its resting memory condition that spans a diameter D1 across a longitudinal axis L for the respective bore

25, FIGS. 5A shows the same lock 20 superelastically deformed to a radially expanded or open condition that spans a larger diameter D2 to thus circumscribe a larger bore 25. The lock 20 is adjusted from the collapsed and closed condition to the expanded and open condition by pulling the opposite facing crown peaks 24,26 circumferentially apart, as shown in bolded opposite oriented arrows in FIG. 5A.

[00117] In addition to increasing the diameter from D1 to D2 of the bore, spreading the crown peaks apart in this manner also reduces the overlap of their respective positions along the circumference of the structure. In fact, as shown in FIG. 5A, the extent of expansion is configured to remove the overlap in favor instead of a circumferential spacing or gap between these opposite facing peaks by a distance D3 as shown. This allows for lateral passageway 28 to include a substantially straight longitudinal space across that gap D3, as shown along the shadowed reference line for passageway 28 in FIG. 5A. This provides a particular benefit in assembling the lock onto a retainer to hold and retain the lock in the expanded and open condition. In one specific regard, an elongated inner retainer tube of appropriate dimension may be loaded into the bore 25 through the lateral passageway 28, such that thereafter the retainer prevents recovery of the material further inward to the resting memory condition of further reduced diameter.

[00118] For clarity, FIG. 5B shows the result of releasing the lock 20 in free space from the expanded and open condition shown in FIG. 5A to the radially collapsed and closed memory state condition with similar shape and size for the filamental tubular pattern of the lock 20 shown in initial memory condition prior to expansion in FIG. 1. This force of material memory recovery back to this resting memory condition, in particular reference to the opposite facing circumferentially oriented peaks 24,26 returning to their circumferentially overlapped relative positions, is reflected in bolded arrows in FIG. 5B. [00119] It is to be appreciated that this arrangement and various modes of use reflected by the respective conditions shown and described in FIGS. 1 and 5A-

B allows for an intermediate mode of use to lock the lock 20 onto a guidewire.

This is accomplished by positioning the guidewire within the bore 25 with the lock 20 in the radially expanded and open condition similar to FIG. 5B, or which may be slightly recovered from that specific condition onto a retainer

(yet still of expanded superelastically deformed diameter), and then allowing the lock 20 to recover onto the guidewire when released form the retainer and on the way toward the fully recovered condition shown in FIG. 5B. As is further developed elsewhere hereunder, to the extent the guidewire outer diameter is greater than the fully recovered diameter D1 , the lock 20 rests on the guidewire with a squeezing recovery force from the material that remains deformed rom the memory condition and diameter while on the larger wire.

[00120] FIGS. 6A-B show a top view of an adjustable guidewire lock 20, similar to that shown in FIG. 1 , held in a radially expanded and open condition similar to that shown in FIG. 5B, according to one retainer embodiment of the present disclosure. More specifically, the present embodiment includes an adjustable inner retainer tube 60 with an outer surface 62 and an inner annular surface 66 that defines bore 25 extending along the longitudinal axis L between two opposite open ends 61 ,63 of the retainer tube 60. Lock 20 includes similar features provided for lock 20 in FIG. 1 , as further referenced in FIGS. 6A-B, and is shown in the present embodiment held in the radially expanded and open condition resting on outer suface 64 of retainer tube 60. This arrangement is achieved, for example, as elsewhere herein described for loading lock 20 onto retainers, including above by reference to FIG. 5A.

[00121] This arrangement provides for an ability to deliver the lock 20 over a guidewire slideably engaged within bore 25 defined by inner annular surface 66 of inner retainer tube 60, and extending coaxially within lock 20, that provides a guidewire tracking passageway for the assembly. This is shown for example via guidewire 70 shown extending through bore 25 in FIG. 6B. [00122] An elongated pull member 68 is coupled to and extends proximally from end 63 of inner retainer tube 60. Pull member 68 allows for the retainer tube 60 to be proximally withdrawn relative to guidewire 70. Lock 20 seated on outer surface 64 provides a "stand-off from that surface that is equivalent to the thickness (in radial axis) of the wire filament 22 of the lock 20. As is further herein developed, a mechanical interface against this stand-off may be created by an actuator that provides a stop to prevent proximal withdrawal of lock 20 during proximal withdrawal of inner retainer tube 60. This allows the inner retainer tube 60 to be removed from within lock 20, to thereby release lock 20 from retention to recover down onto the guidewire for locking engagement.

[00123] FIG. 7 shows adjustable guidewire lock 20, including and referencing similar features as shown in FIG. 1 , held in a radially expanded and open condition similar to that shown in FIG. 5A, yet according to another retainer embodiment of the present disclosure that differs from the embodiment provided in FIGS. 6A-B as follows.

[00124] In the present embodiment, an elongated retainer member 80 has a diameter between opposite edges 82,84 transverse to the longitudinal axis L and that approximates diameter D3 between opposite facing crown peaks 24,26 of lock 20. Retainer member 80 is positioned within the circumferential gap of opposite facing crown peaks 24,26 in the radially expanded and open condition and thus within and extending along lateral passageway 28 otherwise provided in this open condition, as described by reference to FIG. 5A, but for the presence of the retainer member 80. In this arrangement, opposite facing circumferentially oriented crown peaks 24,26 are held apart in confronting engagement with opposite facing edges 82,84, respectively. This provides a mechanical interference to prevent elastic or superelastic recovery of the peaks 24,26 back toward each other, and thus retains the lock 20 in the radially expanded and open condition shown. [00125] Various assemblies are contemplated that provide elongated retainer member 80 in the position shown in FIG. 7 for efficient delivery of the assembly over a guidewire, and subsequent removal of the retainer member

80 from the lateral passageway 28 to release lock 20 from retention and allow it to recover inward for locking onto the guidewire. Certain specific examples are herein shown for purpose of further illustration and to provide a complete understanding of the broad aspects herein presented. These examples are considered to provide certain particular benefits. However, other approaches may be taken by one of ordinary skill, though not herein specifically shown or described, without departing from the broad aspects herein contemplated.

[00126] FIG. 8 shows a cross-sectioned view of one such further embodiment and example for implementing the retainer embodiment just shown and described by reference to FIG. 7 as follows. Retainer assembly 90 is an elongated tubular member, though shown in cross-section in FIG. 8, with an outer surface 98 and an inner annular surface 96 that defines bore 25 extending along and through the retainer assembly 90. A retainer 91 is provided along a radially enlarged region along the outer circumference of retainer assembly 90 with a circumferential width extending between two opposite edges 92,94 that stand-off from outer surface 98. An adjustable guidewire lock 20, which may be similar for example as that shown in FIG. 1 , is retained in a radially expanded and open condition within the semi- circumferential recess around the bore 25 between the opposite edges 92,94 of the stand-off. The filamental wire 22 of the lock 20 is deformed in the radially expanded and open condition with the opposite facing circumferentially oriented crown peaks 24,26 held apart by the distance D3 as a result of confronting engagement between those peaks and the opposite edges 92,94 of the stand-off retainer 91.

[00127] In the specific embodiment shown in FIG. 8, the wire filament 22 of lock 20 is held open with some clearance over outer surface 98 of the recessed portion around the retainer assembly 90. This allows for the recovery force to be isolated to the relatively small surface area of the confronting engagement between peaks 24,26 and the retainer edges 92,94. This specific arrangement may provide less friction between the assembled parts of the lock 20 and retainer assembly 90 for enhanced release from lock retention upon slideably removing the retainer 91 from its location between the lock peaks 24,26. It also provides for enhanced luminal surface 96 for guidewire tracking in further combination with more controlled positioning of the retainer 91 during various modes of use due to its fixed relationship with the tubular wall portion of the retainer assembly 90. It is to be appreciated, however, that the retainer 91 may be provided as a separate part located over a tubular member forming the effectively recessed circumferencial surface 98 and tubular inner surface 96. If provided as a separate part, it may be still secured to the tubular component of the assembly for unitary control and manipulation. Or, conversely the retainer 91 may be positioned in the location shown, relative ot the other component parts, for separate manipulation - though ultimately the inner tubular member on which the retainer 91 forms a stand-off is desirably to be removed from within the lock 20 to allow the material recovery to a radially collapsed and closed position for locking onto a guidewire.

[00128] Alternatives to the retainer embodiment just described are also further contemplated, such according to the further exemplary embodiment shown in FIG. 9 as follows. [00129] More specifically, FIG. 9 shows a cross-sectioned view of a retainer assembly 100 as another retainer embodiment for use in retaining an adjustable guidewire lock 20 in a radially expanded and open condition according to the embodiment shown in FIG. 7. Retainer assembly 100 is an elongated body, though shown in transverse cross-section, that includes a substantially tubular wall with a region of its inner surface providing an interior stand-off as retainer 106 with a width between two opposite edges 102,104 and that extends into and partially circumscribes a portion of bore 25 that extends between two open ends of the tubular assembly (not shown). A semi- circumferential recess 108 relative to stand-off 106 circumscribes the remaining portion of the bore 25 between opposite edges 102,104 of retainer 106. The adjustable guidewire lock 20 is positioned within the recess 108 with opposite facing circumferentially oriented peaks 24,26 deformed circumferentially apart and positioned in confronting engagement with opposite edges 102,104, respectively, of retainer 106.

[00130] In this arrangement just described, retainer 106 provides a mechanical interference to prevent superelastic recovery of the lock 20 to the radially collapsed and closed condition, thus retaining it in the radially expanded and open condition. As noted for the embodiment shown in FIG. 8, the retainer 106 is retracted and the lock is released from retention by proximal withdrawal of the retainer assembly 100. Also as noted for the FIG. 8 embodiment, the integral relationship of retainer 100 and other aspects of retainer assembly 100 may be modified to incorporate separate component parts. However, in the present embodiment, it is contemplated that upon separate withdrawal of the retainer 106 stand-off from the other tubular wall component of retainer assembly 100, the lock 20 is not prevented from full material recovery and adjustment to the closed and locked position when released. This is because the remaining wall components of the retainer assembly 100 form an outer tube around the outside of lock 20, versus located interiorly of the lock 20 as provided in the FIG. 8 embodiment.

[00131] However, it is also contemplated that the embodiment of FIG. 9 does not take similar advantage of a lateral passageway formed by spreading the lock peaks 24,26 apart to load the retainer assembly into the lock, as does the embodiment of FIG. 8. In the present embodiment of FIG. 9, the lock 20 is loaded in a different manner into the inner confines of retainer assembly 100 in order to employ the intended purpose of retainer 106 within that assembly 100. While multiple approaches may be taken to accomplish this without departing from the broad scope intended for this embodiment, one example is provided as follows. The retainer assembly 100 may be provided with a lateral opening or passageway between the ends of the tube and bore 25, such as by providing longitudinal groove or cut in a formed tube, such as for example at location 109 shown in FIG. 9. By spreading the wall of retainer assembly 100 open at this location 109, bore 25 can be opened for loading the lock into the bore for engagement with the retainer, followed by subsequent recovery of the wall to closed or semi closed condition prior to spreading it at the groove. Also, by providing retainer 106 as a separate component part as stand-off from the other wall component, it can be loaded between the opposite facing peaks 24,26 followed by insertion of that assembly into a separate tube such that retainer 106 stands-off into the interior of the tube, and the lock 20 is retained within the tube, to complete the retainer. This may be done by slidably loading the retainer-lock sub-assembly into the tube, which may also include for example heat shrinking the tube over the sub-assembly (which may include another work piece within the sub-assembly to preserve desired geometric interfacing of the tube with these other component). Such heat shrinking may also provide a fused or melted joint between the retainer and the outer tube, to provide a unitary result for manipulation between them. [00132] Still further variations are contemplated as further retainer embodiments of the present disclosure. [00133] FIG. 10 shows for example a cross-sectioned view of another retainer embodiment for use in retaining an adjustable guidewire lock in a radially expanded and open condition according to the embodiment shown in FIG. 7. More specifically, a retainer assembly 110 includes similar features as that shown in FIG. 8, except in the present embodiment longitudinal grooves or recesses 113,115 are provided within the opposite edges 112,114, respectively, of the retainer 116 provided as a exterior stand-off from an otherwise tubular wall 118. These grooves 113,115 provide for enhanced retention of the crown peaks of a lock seated against the retainer 116, and may be either flush with the outer surface of tubular wall 118, or may be located themselves along the respective edges spaced above that surface to provide further stand-off of the wire filament of the lock.

[00134] For further illustration, FIG. 11 shows a cross-sectioned view of another retainer assembly 120 that provides yet a further retainer embodiment that combines certain features of the embodiment shown in FIG. 9 with the grooved enhancement to the retainer assembly embodiment shown in FIG. 10.

More specifically, laterally placed longitudinally extending grooves 123,125 are located along edges 122,124, respectively, of retainer 121 shown. [00135] While various retainer assemblies have just been shown and described by reference to certain illustrative embodiments above with respect to retaining locks in radially expanded and open conditions, these retained locks are to be adjusted such that the respectively retained lock is released from retention for locking onto a guidewire. Certain further aspects of this mode of operation with respect to the various retained lock embodiments are further developed as follows. [00136] FIG. 12 shows a combination assembly of lock 20 and retainer 80 previously illustrated and described by reference to FIG. 7, but in a subsequent mode of use to adjust the lock to the closed and locked condition.

More specifically, as shown in bolded arrow in the Figure, retainer 80 is retracted from the lateral passageway 28 between opposite facing crown peaks 24,26 of lock 20, such that opposite edges 82,84 no longer provide mechanical interference against opposite facing crown peaks 24,26 from recovering inward toward their memory shape and condition. In other words, adjustable guidewire lock 20 is allowed to adjust to a radially collapsed and closed condition by memory recovery of the elastic or superelastic material forming the filamental structure of the lock. [00137] The relative repositioning of the retainer relative to the respectively retained lock, as just described immediately above, may be accomplished according to a variety of suitable approaches. In general, such approaches provide some sort of mechanical interference against the lock, which is compressed with force in some way against the respective retainer, from moving with an applied force and motion on the retainer. Or, the retainer may be prevented from moving upon some applied force and motion placed on the lock. For further clarity, certain particular examples of providing such an intended result for releasing the lock from the retainer are provided by further illustrative embodiments as follows. [00138] FIG. 13 shows a cross-sectioned view of the retainer assembly 90 shown in FIG. 8, but in combination with an actuator 136 according to one embodiment. Actuator 136 is shaped to fit around the retainer assembly 90 in a configuration that provides a mechanical stop against the lock held open by the retainer (as shown in FIG. 8). Upon proximal withdrawal of the retainer assembly 90 relative to the actuator 136, the lock is prevented from proximal withdrawal with the retainer assembly 90 and is thereby released from the retainer assembly 90. This may be accomplished for example by providing a push-pull combination of forces between the retainer assembly 90 and actuator 136. Again, as elsewhere herein noted, either the retainer assembly 90 may be moved out from the respectively retained lock, or the lock may be moved out from the respective retainer assembly, or both may experience motion, whereas the application of "push-pull" may provide such variations in results or methods for releasing the respective sub-assembly.

[00139] For further illustration, FIG. 14 shows a cross-sectioned view of the retainer assembly 100 shown in FIG. 9 in combination with another actuator 130 according to another embodiment. Actuator 130 is fit and positioned relative to the retainer assembly 100 in a configuration that provides a mechanical stop against the lock held open by the retainer assembly 100. Upon proximal withdrawal of the retainer assembly 100 relative to the actuator 130, the lock is prevented from proximal withdrawal with the retainer assembly 100 and is thereby released from the retainer assembly 100. Other variations and methods of use similar to those just described above by reference to FIG. 13 may also be incorporated with this present embodiment.

[00140] FIG. 15 shows a top view of another assembly 100 of a lock 20 simolar to that shown in FIG. 1 , and retainer 60 similar to that shown in FIGS. 6A-B, and with a slideably engaged guidewire 70 in a similar arrangement to the embodiment shown in FIG. 6B. However, the present embodiment provides this sub-assembly of parts in further combination with another actuator 142 according to another actuator embodiment. More specifically, guidewire 70 has a diameter OD1 that is slideably received within tubular retainer 60 that has a diameter OD2 that is slideably received within tubular actuator 142 having a diameter OD3. While tubular actuator 142 has sufficient clearance over tubular retainer 60 to provide slideable engagement to achieve relative motion between them during intended use, lock 20 is seated upon tubular retainer 60 with wire filament 22 providing a stand-off over that retainer's diameter OD2. This stand-off and diameter D3 are chosen to provide for confronting mechanical interference between the wire filament 22 and distal edge 144 of tubular actuator 142 during proximal withdrawal of retainer 60 relative to tubular actuator 142. Accordingly, again in a push-pull mode of use, the retainer 60 may be withdrawn proximally relative to tubular actuator 142, which prevents lock 20 from withdrawing, such that lock 20 is released form the retainer 60 and allowed to recover with locking engagement down onto guidewire 70. As elsewhere described by reference to other embodiments, the push-pull and relative motion between lock 20 and retainer 60 may be achieved in a number of different ways according to the construction of the parts and uses employed in their operation. ] For further illustration, FIG. 16 shows a sub-assembly arrangement between a lock 20, retainer 60, and slidably engaged guidewire 70 similar to that shown in FIG. 15, but including in further combination with still another actuator embodiment provided by actuator assembly 150. More specifically, actuator assembly 150 includes an outer tubular wall 152 that extends at least to a stop 154 which provides an interior stand-off from an inner surface 153 of tubular wall 152. Stop 154 may be for example an annular ring, and may be in further embodiments radiopaque such as for example tungsten, platinum, gold, blends or alloys, or may be of other construction such as stainless steel or of polymeric construction, for example. Regardless of the particular construction chosen, the stop 154 is configured to intrude into the annular space between the outer diameter of outer surface 62 of retainer 60 and the inner surface 153 of outer tube 152, sufficiently to provide a mechanical interference against wire filament 22 of lock upon proximal withdrawal of retainer 60 relative to stop 154. Again, as indicated by one combination of bolded arrows in FIG. 16, various combinations of pushing and pulling on the respective retainer and actuator may be employed in combination with appropriate specific implementations of the respective embodiment to achieve the release intended.

[00142] In the particular embodiment shown in FIG. 16, stop 154 is provided at a discrete location to confront the proximal edge of lock 20. According to this embodiment, the stop may be customized as to shape and position to provide the result intended in operation relative to the feature of lock 20 against which it interfaces. For example, if lock 20 is not completely circumferential where it confronts stop 154, then stop 154 may be also only partially circumferential in construction. Also, [00143] It is contemplated that by providing a discrete actuator to confront a lock at only its proximal edge to remove it from a retainer, the lock thereby must transmit applied force along it to slideably release it from the respective retainer. This is considered, and has been observed to be, suitable in many circumstances. However, in further embodiments not specifically herein shown, a series of stops may be provided to confront multiple features of a respective lock along its length and/or circumference, in order to enhance actuation for release from the respective retainer. For example, while FIG. 16 shows stop 154 to provide mechanical interface only against lock 20 adjacent to peak 24, one or more additional stops may be provided, such as for example located between peak 24 and adjacent peak 26 in order to confront both of them for more efficient force transmission to achieve efficient release. It is further appreciated that providing such stops along the lock's length may present unique real estate considerations within a sheath such as shown at 150, as proximal stop 154 is radially clear of lock 20 but another distal lock may need to be configured of appropriate shape and positioned in a void of lock 20 in order for the parts to fit and function as intended in the overall assembly.

[00144] While the various illustrative embodiments above have been described principally with respect to use with a lock similar to that shown in FIG. 1 , it is to be appreciated that these embodiments may be efficiently employed using other specific locks, including those that may share certain features of the lock of FIG. 1 but otherwise vary with respect to other features. Certain broad aspects represented by lock 20 in the prior embodiments, and in particular FIG. 1 , are thus illustrated by the following additional examples and embodiments shown in FIGS. 17A-18 as follows. [00145] FIGS. 17A-C show different views for purpose of complete understanding of another adjustable lock 200 according to one such further exemplary embodiment, and which includes a semi-tubular wall 202 with an outer surface 206 and an inner surface 204 that substantially circumscribes a bore 205 extending along longitudinal axis L between two open ends 201 ,103, respectively. A laterally positioned, longitudinally extending passageway 208 is provided as a groove or cut in wall 202 with confronting opposite edges

207,209, respectively, and that extends between ends 201 ,203.

[00146] This substantially tubular member 200 may be employed in much the same way described for lock 20 in the prior embodiments above, providing it with material memory in a recovered condition that is radially collapsed and closed with a small diameter relative to a deformed radially expanded and open condition retained in a retainer for delivery over a guidewire through bore 205, and subsequent release for guidewire locking under force of material memory recovery. In addition, groove passageway 208 through wall 202 may serve similar purposes in various sub-assemblies and intended uses as provided for lateral passageway 28 of prior embodiments.

[00147] Furthermore, the cut or otherwise patterned groove passageway 208 may also take on different patterns, such as for example shown in FIG. 18. Here, lock 220 which provides an undulating shape with a respective peak of one edge 207 of the otherwise similar passageway 208 seated within a mating valley 205 of the opposite edge 205. This provides opposite facing, circumferentially oriented, alternating peaks along the length of the tube wall 202, with potential similar implications in certain circumstances as alternating peaks 24,26 of prior embodiments (and thus may be included in such embodiments as further variations thereof). [00148] As also shown for illustration in FIGS. 17A and 18, other features may be provided in the respective lock embodiments in these respective Figures, including for example holes or apertures 210,212 shown. These may provide additional feature for engaging a retainer on either side of lateral passageway 208, or for grasping and/or manipulating the wall 202 apart at lateral passageway 208 in a manner allowing for loading into a respective sub- assembly in a radially expanded and open condition, such as according to still further embodiments described immediately below or elsewhere hereunder this disclosure. [00149] While various illustrative embodiments have been shown and described in the embodiments above for retaining various locks in radially expanded and open conditions, and releasing them from retention for recovery to radially collapsed and closed conditions, multiple approaches may also be taken for initiating this process by expanding such locks to the open conditions from their initial resting memory state in a closed condition. Certain particular illustrative examples of fixtures, tooling, and other approaches for such process are herein provided, and are considered to present certain particular benefits. Nonetheless, various aspects of the present disclosure are contemplated broadly and without necessarily requiring limitation by such specific embodiments.

[00150] FIGS. 19A-B show one such exemplary expansion fixture embodiment in two modes of use for expanding a lock 20 similar to that shown in FIG. 1 from a radially collapsed and closed memory condition with a first diameter, shown in FIG. 19A, to a radially expanded and open deformed condition with a larger second diameter, shown in FIG. 19B and similar to that shown in FIG.

5A. According to this present embodiment, a thread, ribbon, or other form of low profile tension member is used to loop around the wire filament 22 of lock 20, such as shown at filaments 250,256 engaged with opposite facing crowns 24,26 of lock 20. By pulling with tension on these filaments, the crowns 24,26 are pulled apart, as shown by way of bolded arrows in FIG. 19B. [00151] FIGS. 19C-D show another expansion fixture embodiment in two modes of use for expanding a lock 20 similar to that shown in FIG. 1 from a radially collapsed and closed memory condition with a first diameter, shown in FIG. 19C, to a radially expanded and open deformed condition with a larger second diameter, shown in FIG. 19D and similar to that shown in FIG. 5A.

However, according to this present embodiment pull rods or spatula's 270,280 are employed to engage and pull apart crown peaks 24,26 of lock 20. These include hooks or bends 272,282, respectively, that engage the crown peaks 24,26 for pulling. Once pulled apart, as per various other embodiments, the peaks 24,26 are released from the hooks 272,282 in a retained open position on the respective retainer.

[00152] The loading fixtures and approaches just described may be done manually, or may be adapted into more automated approaches, or a mixure of the two may be implemented. For example, engaging and looping or hooking the respective lock peaks may be done manually, after which the respective pull members are secured in a fixture that automates or controls extent or force of pulling for controlled expansion.

[00153] FIGS. 19E-F show two views of another expansion fixture embodiment for expanding a lock similar to that lock 20 shown in FIG. 1 from a radially collapsed and closed memory condition with a first diameter to a radially expanded and open deformed condition with a larger second diameter, such as for loading onto a retainer. This embodiment provides a particularly controlled engagement with the respective lock and expansion by providing two coordinated fixtured parts that each engages one of the two opposite sides of the lock corresponding with opposite facing crown peaks 24,26 around a lateral passageway 28 as per other present embodiments. More specifically, expansion fixture 300 includes first and second pull fixtures 310,330 that include edges with multiple extended members 314,334, respectively, arranged in series along the respective edges and separated by spaces or valleys 318,338, also respectively between these extended members. These are arranged so as to position the extended members of one pull fixture within the valleys of the other pull fixture, such as in a keyed relationship. The extended members 314,334 are bent to provide hooks 316,336, respectively, in which the crown peaks of the lock to be expanded may be hooked and seated. In the arrangement shown, a particular pattern of opposite facing, circumferentially oriented crown peaks which correspond with the respective opposite facing hooks 316,336 of the two opposite pull fixtures may be hooked in coordinated fashion, with the alternating series of each set of oriented crown peaks engaged within each of the alternating series of hooks of one of the pull fixtures. Once so positioned relative to a lock, the lock is efficiently pulled apart merely by pulling apart the pull fixtures, as shown in bolded arrows in FIGS. 19E-F.

[00154] It is also contemplated that pulling apart crown peaks of a lock in a planar fashion may not provide the optimal results for a given lock design. This may for example concentrate material strain during the fixtured expansion that exceeds superelastic range with a resulting plastic deformation or unwanted hysteresis or even yield failure/fracture. Accordingly, the applied force of expansion may be applied in other vectored arrangements, such as with some rotation for example, as shown variously in shadowed arrows in FIG. 19F. [00155] Further to the FIGS. 19E-F, other features may be provided in expansion fixture 300 for additional intended benefits. For example, as shown in shadow in these Figures, holes or apertures 320,322 may be formed in the hooks 316,336, respectively, in order to secure the hooks during pulling expansion of a lock, such as shown by engaging aperture 320 over a peg 326 in FIG. 19F extending from extended member 314. This encloses the lock wire filament within the respective hook and prevents the hook from straightening and releasing the engaged crown peak during applied tension force of pulling. As would be apparent to one of ordinary skill, this feature may be employed in other embodiments herein presented as well. [00156] FIGS. 20A-C show various views of various sequential steps of manufacturing another highly beneficial embolic filter module 400 with both an adjustable lock assembly and a filter support assembly formed from a single piece of material as an integral support scaffold body construction as follows. [00157] FIG. 2OA shows an elongate tubular body or tube 410, such as in particular for example a nickel-titanium tube, as a starting material. Tube 410 includes a tubular wall 412 with an outer diameter d1 , and a through lumen

414 that is adapted to ultimately form a guidewire lumen 414 extending between two guidewire through ports at ends 416,418, respectively. [00158] FIG. 2OB shows the tube 410 after patterned laser cutting as follows. A first region of tube 410 is cut in a first pattern that is adapted to function as an adjustable lock assembly 420. In the particular version shown, adjustable lock

420 comprises a wire filament 422 providing a patterned structure with an alternating series of opposite facing, circumferentially oriented crown peaks that are separated by a longitudinally continuous gap or lateral passageway 424 left by the laser cutting. These peaks are adapted to deflect from a memory condition (and recover from deflection back to the memory condition) such that, according to the pattern cut, the tubing in this region has an adjustable diameter transverse to the guidewire lumen 414. A second region 430 is cut in a second pattern that is adapted to provide a filter support scaffold 430. This includes a plurality of longitudinal struts or splines 432 that are spaced about the circumference by longitudinal cuts or voids 434.

Additional structural considerations, as well as relative functions and purposes, of these first and second regions 420,430 and corresponding patterned network of nickel titanium filaments or struts 422,432 are elsewhere herein described in further detail. [00159] It is to be appreciated that tube 410 in the initially cut configuration shown in FIG. 2OB has a diameter d1 along its length L1 and at both regions 420,430. It is to be appreciated therefore by one of ordinary skill reviewing this disclosure that the term "tubular" or "substantially tubular" as herein used and contemplated may be either an "enclosed" tubular shape, such as for example that shown in FIG. 2OA, or may be slotted or otherwise with gaps in the wall through which interior and exterior spaces relative to the wall may communicate, such as for example as shown in FIG. 2OB. In either case, the structure is considered substantially tubular to the extent that an interior passageway is definable along a length and whether or not that passageway is completely "enclosed" along that length. [00160] After the cutting operation and the respective patterned regions are formed as schematically shown in FIG. 2OB, the respective patterned regions are then subjected to nickel-titanium material processing techniques that alter the material properties to thus retrain the material to a new memory condition in a new shape (versus the tubular starting material memory). This retraining and resulting geometry is hereafter referred to as the "trained configuration".

The trained configuration according to the present embodiment is that shown in FIG. 2OC, and which is described in further detail as follows.

[00161] FIG. 2OC shows adjustable lock assembly 420 in its retrained memory condition with a memory in a recovery diameter d2 that is smaller than the initial tubing diameter d1 , and is also smaller than the outer diameter of the guidewire onto which lock assembly 420 is intended to lock (shown schematically in this Figure as guidewire 440). According to the superelastic alloy mode for the nickel-titanium alloy material used here, this recovered tubing at dimension d2 may be expanded to a larger diameter and held open by a radially supporting inner member (not shown), as schematically shown at diameter d3 in shadow in FIG. 2OC. This constitutes the open or delivery configuration for the adjustable lock assembly 420.

[00162] Accordingly, it is to be appreciated that the adjustable locking assembly 420 is initially provided at original diameter d1 , is retrained to a reduced diameter d2, and is artificially deflected open under an applied force to the enlarged diameter d3. This radial outward deflection is accomplished by an inner retainer member that is adapted to track the open lock assembly 420 slideably over a guidewire to the location where filtering is to be performed. Upon positioning at this location, the inner retainer member is withdrawn out from under the adjustable lock assembly, which is thus released to recover downward back to its memory condition at diameter d2. However, it encounters the guidewire with greater outer dimension than d2, and thus continues thereafter to squeeze with material recovery strength onto that wire.

This is considered the locked configuration for adjustable lock assembly 420.

[00163] FIG. 2OC also shows filter support scaffold 430 in its retrained, recovered memory condition. Here, longitudinal splines 432 are deflected radially outward as the initial length of the region 11 (FIG. 20B) is reduced to I2

(FIG. 20C). This forms a lantern-shaped pattern of curved, circumferentially spaced splines. This pattern forms a scaffold to which a filter member 436 is coupled to form an adjustable filter assembly. Filter member 436 is shown in FIG. 2OC as a porous membrane that may be chosen from several acceptable materials as apparent to one of ordinary skill based upon review of this disclosure. In the recovery condition and radially extended configuration shown for filter scaffold 430 in FIG. 2OC, the splines 432 support filter member 436 to substantially span across a diameter d4. Recovery diameter d4 is greater than original diameter d1 of the tubing region where the filter support assembly was formed (prior to retraining the material), and is adapted to approximate (or be slightly greater than) a diameter of a blood vessel where filtering is to be performed. Accordingly, the supported filter member 436 is adapted to substantially span the cross section of blood flow through the respective filtering region.

[00164] According to the foregoing, the overall adjustable filter module according to the present embodiments is adjustable between a first configuration and a second configuration. In the first configuration, the adjustable lock assembly 420 is retained radially expanded in its respective open configuration, and the adjustable filter assembly 430 is retained in a radially collapsed condition. This combination of configurations for the respective component parts of the overall assembly allows it to be slideably engaged with and track over a guidewire 440 to the desired filtering location. Thereafter, the adjustable lock assembly 420 is adjusted to a locked configuration with a reduced diameter that squeezes onto guidewire 440, and the adjustable filter assembly 430 is adjusted to a radially extended configuration that spans filter member 436 substantially across the blood vessel for efficient filtering.

[00165] The particular tubing used to form this integrated support scaffold shown in FIGS. 20A-C, and related retraining process, is based upon an initial tubing inner diameter dimension intended to be well toleranced to track over a corresponding guidewire upon final assembly, and while maintaining a low profile. Among other possible considerations, certain annular cuff regions continue to exist (e.g., between the filter support scaffold and the lock assembly, and distal to the filter support scaffold) that remain at the original dimension. For example, a tubing of between about .016" to about .018" inner diameter would be appropriate for constructing an integrated support scaffold body as shown for use over a .014" guidewire (and is similar to the type chosen for the physical embodiments shown elsewhere in the Figures). However, it is also contemplated that a tubing may be chosen at other dimensions, with corresponding changes in the design and retraining methods.

For example, a tubing of the intended lower recovered diameter d2 may be used as starting material so long as all portions may be either retrained or expanded to larger dimensions to accommodate the intended guidewire trackability during use. [00166] It is also contemplated that, though various of the present embodiments describe a superelastic form of nickel-titanium used in the assemblies, shape memory states of the material may also be employed to achieve the overall broad objectives of the embodiments. Furthermore, other materials than nickel-titanium, such as other superelastic alloys, or other elastomeric or elastic materials, may be used as substitutes in certain circumstances to the nickel-titanium embodiments herein described in detail. Still further, though the particular designs and arrangements shown and described are highly beneficial, other modifications may be made, such as with combination with other embodiments or otherwise, without departing from the intended broad scope of the various aspects. [00167] It is to be appreciated that various delivery assemblies may be employed to accomplish the foregoing. However, one particular beneficial delivery assembly 500 is described for illustration by reference to FIG. 21.

FIG. 21 shows an embolic filtering system according to the present embodiments that includes a delivery assembly 500, adjustable filter module

550, and guidewire 580. Further detail regarding these components and their respective inter-relationships with respect to overall structure and use of the resulting filtering system are described as follows.

[00168] Delivery assembly 500 includes an inner member 510 with a tubular wall 512 that defines an inner lumen 511 and with a distal end portion 514.

Inner lumen 511 is fairly tightly toleranced over an outer diameter of guidewire 580 that resides therein, but allowing for acceptable slideable engagement and trackability. Delivery assembly 500 also includes an outer member 520 that is a tubular wall comprising a proximal end portion 522 and distal end portion 524 and that defines an inner passageway that comprises lumen 521 and inner lumen 523, respectively, along proximal and distal end portions 522,524. This inner passageway of the outer member 520 is coaxially engaged over inner member 510 along inner lumen 521 and a portion of inner lumen 523. Proximal end portion 522 and distal end portion 524 are coupled together at a joint 528 that also includes a circumferential band 526 located at the distal end of proximal end portion 522 and the proximal end of distal end portion 524. Distal end portion 524 has a greater diameter than proximal end portion 522, and extends distally beyond the distal end portion 514 of inner member 510. [00169] Also shown in FIG. 21 , adjustable filter module 550 has a similar construction as that previously described by reference to FIG. 2OC. Filter module 550 includes an adjustable lock assembly 560 with a nickel-titanium wire filamental structure 562 in an undulating pattern that has an adjustable diameter, in addition to other features, such as elsewhere herein described by reference to lock 20 of other embodiments of this disclosure. Filter module

550 also includes an adjustable filter assembly 570 with a support scaffold having a plurality of splines 572 also similar to those described in FIG. 2OC.

Also included is a porous filter member 574 supported by splines 572.

[00170] The inter-cooperation of inner member 510 and outer member 520 of delivery assembly 500, the adjustable lock assembly 560 and adjustable filter assembly 570 of adjustable filter module 550, and guidewire 580 is described in further detail as follows.

[00171] Distal end portion 514 of inner member 510 extends distally beyond joint 528 of outer member 520 and provides a radial inner support that holds the superelastic nickel-titanium wire filament 562 of adjustable lock assembly 560 radially open in a deflected condition corresponding with the open configuration for the lock assembly 560. This is accomplished according to embodiments elsewhere herein described. Or, this arrangement (or other lock-retainer sub-assembly loading arrangements) may be accomplished for example by sliding the lock assembly 562 over a tapered hypotube of appropriate larger dimension to release the lock assembly 562 over onto the outer surface of inner member 510. Then, once the lock and retainer (inner member) are so assembled, the retained lock assembly and inner member are withdrawn in a "back-loaded" manner into outer member 520 until proximal end portion 568 of lock assembly 560 confronts joint 528 in a manner designed according to their respective dimensions to provide a mechanical tolerance interference relative to longitudinal axis L. As would be apparent to one of ordinary skill, this arrangement is thus a further more detailed embodiment of that shown and described by reference to FIG. 16.

[00172] At this point, lock assembly 560 retained on distal end portion 514 of inner member 510, and filter assembly 570 are all housed within the respectively larger distal inner lumen 523 within distal end portion 524 of outer member 520. Only inner member 510 extends proximally therefrom through joint 528 and along the respectively smaller proximal inner lumen 521 within proximal end portion 522 of outer member 520. The distal end portion 524 of outer member 520 provides a radial confinement sheath and housing to conceal adjustable filter assembly 570 in a radially confined configuration with significantly reduced diameter deflected from the superelastic radially extended memory condition of the respective nickel-titanium support scaffold of struts 572. The proximal end portion 522 provides a low profile assembly proximal of joint 528. [00173] This arrangement just described thus provides an efficient use of radial dimensioning to minimize profile where possible while maintaining the overall functionality and objectives of the system. The assembly just described and as shown in FIG. 21 thus represents the first configuration for the filter assembly and system. This configuration is suitably adapted to slideably engage and track over a guidewire 580 extending through inner lumen 511 of inner member 510 and guidewire lumen 554 through the integrally formed scaffold body of filter assembly 550, while conserving profile through the vasculature to the site where filtering is to be performed.

[00174] Once at that filtering location, the filter assembly is deployed onto the guidewire and into the vessel as follows. As shown schematically in opposite facing bold arrows in FIG. 21 , inner member 510 is withdrawn proximally relative to longitudinal resistance placed on outer member 520 in a "push-pull" coordinated arrangement. In doing so, proximal end 568 of lock assembly 560 confronts joint 528 that functions as a stop against further proximal withdrawal of lock assembly 560. As a result, distal end 514 of inner member 510 slides proximally out from underneath lock assembly 560, and is withdrawn from inner lumen 523 of distal end portion 524 and into inner lumen 521 of proximal end portion 522 of outer member 520. This releases lock assembly 560 from radial retention from the inner member in the open configuration, and allows memory recovery of the superelastic material radially inward onto guidewire

580 to the locked configuration.

[00175] Once the lock assembly 560 is locked onto guidewire 580 in this manner, then all of outer member 550 is withdrawn proximally against longitudinal resistance applied to guidewire 580, again in a "push-pull" coordinated arrangement. By retaining the positioning of guidewire 580 within the artery, filter assembly 550 is also retained at the filtering location where it was locked onto the guidewire. Thus, during the proximal withdrawal of outer member 520, distal end portion 524 of outer member 520 withdraws proximally from filter assembly 550, freeing support scaffold struts 572 from the confinement that previously held them in the radially collapsed configuration within inner lumen 523. This releases the filter support scaffold 570 to allow memory recovery of the superelastic struts 572 radially outward to the radially extended configuration, such as that shown in the embodiment of FIG. 2OC. This deploys the porous filter membrane 574 across the vessel at the filtering location for efficient filtering of blood emboli. ] It is to be appreciated that, once deployed onto the guidewire 580 and across the respective vessel at the filtering location, the filter assembly 550 will be later thereafter removed from the patient. In this mode of operation, a subsequent capture sheath (not shown) will be advanced distally over guidewire 580 to recapture the filter assembly 570 back toward a radially collapsed condition for withdrawal. This may be the same outer member 520 used in the delivery assembly 500 just described. In general, some differences exist with respect to the desired structural features for the initial capture sheath and the retrieval capture sheath. For example, the initial capture sheath is generally adapted to provide robust radial integrity and low profile for crossing proximal lesions, as well as structural integrity under tension during withdrawal from the contained filter assembly. However, the retrieval sheath may enjoy fewer profile constraints, such as for example following a recanalization of a proximal occlusion. And, the entire system including introducers may be withdrawn together after the procedure is completed. Also conversely, the retrieval sheath also is generally adapted to provide certain mechanical properties during compression under distal advancement against the splines 572 to groom expanded filter assembly 570 back to a reduced profile. Thus, it is contemplated that the capture sheath employed may be different in certain circumstances than the outer sheath assembly used for initial delivery. [00177] Various different particular materials may be chosen as appropriate for the particular component parts of the delivery system 500 just described, as would be apparent to one of ordinary skill based upon review of this disclosure. However, for clarity of illustration, certain particular beneficial materials are described as follows. Low profile construction is desirable; for example a filter system with delivery assembly as described for use over a .014" guidewire and having a profile of less than about 3.5 French, and in further embodiments less than about 3.0 French, and still more particularly in certain circumstances less than about 2.8 and even about 2.5 French, would be in particular highly desirable for many cases. In the setting of these dimensional objectives, strong, thin-walled tubings are highly desirable to the extent other desired characteristics may be achieved. And, in many cases, composite tubing constructions may be of particular benefit.

[00178] For purpose of providing further illustration of the interplay between the various component parts such as in a system similar to that described by reference to FIG. 21 , Table 1 is also herein provided appended to the end of this disclosure in order to provide certain exemplary outer and inner dimensions for an adjustable locking filter module provided in a delivery system. [00179] In general, due to the desire to track over a guidewire, and sometimes to difficult, tortuous anatomy, a transverse flexibility is generally desired for most components. However, other structural considerations often are to be taken into account as well. For example, radial strength is often desired, such as for example strength to resist crushing against inward forces at the distal end 514 of inner member 510 of the FIG. 21 embodiment. In certain such circumstances, a coil reinforced polymer composite may be a suitable construction for this part. However, if the lock assembly design provides fairly uniform radial compression, annular tubular support may be sufficient in some material constructions (e.g. polyimide) to provide the desired qualities. In another example, the distal end portion 524 of outer member 520 may be a high radial strength, thin walled material as it is not required to provide substantial pushability as much as radial retention against outward expansion of its contents, and tensile strength for withdrawal. Here polyimide may suffice as well, though more flexible materials such as high radial pressure integrity, thin wall material like PET, HDPE, nylon, etc. may be particularly desirable. [00180] Whereas grooming of an expanded filter assembly into the outer sheath is required in both the delivery system and the recapture system, ovalization of the sheath wall under force of the splines 572 may also be undesirable as such would serve to reduce available cross-sectional area and available real estate for the captured contents. Thus, with other desired characteristics in mind, a wire or ribbon wound composite structure here may be beneficial, oriented in the composite support structure to prevent such ovalization with robust roundness maintained under applied focal point forces from within, and while maintaining desired lateral flexibility.

[00181] It is also contemplated that particular surface characteristics may be desired at certain locations within the assembly, such as for example on the outer surface of the retaining portion of inner member 510, or the inner surface on the distal retaining portion 524 of outer member 520, or at the "push-pull" sliding interface between the inner and outer members 510,522. Coatings such as silicone or hydrophilic coating may be useful, though within the radial lock mechanism lubricity is not typically as desirable when tight gripping onto a guidewire is the ultimate goal. Thus surfaces such as PTFE, FEP or other coated materials with some structural integrity (vs. chemicals that may migrate and transfer) may be desired.

[00182] According to various aspects of the present embodiments just shown and described, certain exemplary physical specimens of adjustable filter modules have been built and observed during various modes simulating intended use. Where similar structures are shown as other examples of other embodiments herein shown or described, similar reference numerals are used for simplicity and continuity of understanding between the Figures. [00183] The embodiments just described by reference to FIGS. 20A-21 provide a more detailed illustration of the lock embodiments of the present disclosure as incorporated into certain overall filter and delivery assemblies. However, other types and forms of filter assemblies are contemplated than reflected in those specific embodiments. In one particular example, these prior embodiments referenced a "lantern" style of filter support scaffold utilizing a circumferentially spaced array of longitudinally extending struts to support open a filter membrane. However, other support scaffolds such as loops that hold open filter membranes at their "mouths" with the filter membrane extending downstream therefrom as pouches are also contemplated.

[00184] FIG. 22 shows a two-dimensional CAD drawing of a pattern for laser cutting a tube according to another integral scaffold embodiment of the present disclosure providing an adjustable lock and filter scaffold from one integral piece of material, except providing a loop-style filter support scaffold. In the particular pattern shown. More specifically, integral filter scaffold 582 includes at one end a lock 583 that is a filamental wire structure 584 in an undulating pattern of alternating opposite facing circumferentially oriented crown peaks 585,586 as elbow bends in the wire 584 provided in spaced series along longitudinal axis L between proximal end 587 and a distal end where an annular transition ring 588 is provided. An arm 589 extends between transition ring 588 and a loop 590 that comprises an annular filament or strut 592 around a bore 593 over a length 594 in the "as cut" pattern shown.

In this arrangement, arm 589 and loop 590 are to be retrained in a manner that provides a filter membrane support assembly when retrained in a desired memory shape in a radially expanded and open condition with a filter sock or pouch secured to the loop 590 (such as shown in FIG. 23). [00185] In one overall configuration according to the particular laser cutting pattern shown for a more detailed illustration, various suitable dimensions for certain component parts just described may be for example as follows (in inches): lock 583 has a distance D1 between opposite peaks 585,586 equal to about 0.0817 (which is circumference of the cut structure shown planar in the Figure, for an overall result of about 0.026 outer diameter as cut tube); wire 584 has a general width W1 equal to about 0.0049; peaks 585,586 have radii of curvature equal to about 0.0119; inter-peak period distance P between adjacent similarly oriented peaks over a full undulation cycle is equal to about 0.0650; width W2 of transition ring 588 is equal to about 0.0233; width of arm

589 is equal to about 0.0098; and length 594 over which loop 590 is cut is equal to about 0.3000. These dimensions are exemplary, and may be modified to maintain similar ratios to achieve similar results at different overall dimensions, or may be modified relative to each other to yield certain potentially different results in a given overall structure. [00186] The integral filter support scaffold embodiment just described provides an integral skeleton that may be reformed with the superelastic material retrained in a similar manner as elsewhere herein described, and to be assembled together with a filter membrane and retainer in a delivery system, such as for example in regards to various aspects presented for other embodiments disclosed hereunder, such as the embodiments shown in FIGS. 20A-C and 21. One particular exemplary overall filter assembly deployed and locked onto a guidewire is shown in FIG. 23.

[00187] More specifically, FIG. 23 shows a picture of an adjustable filter module 595 constructed by securing a filter membrane 596 to a filter support scaffold

590 of an integral scaffold 582 cut from a tube according to a similar pattern and per similar features as that just shown and described by reference to FIG.

22. The respective integral lock 583 is shown in the closed and locked condition locked onto a commercially available 0.014" guidewire 598, more specifically a 0.014" High Torque Floppy-ll guidewire previously made commercially available by Guidant Corporation (now Abbott Vascular). While the membrane 596 used in the particular physical embodiment shown does not include actual holes or pores, these may be made according to one of ordinary skill in the art, and according to methods and patterns and/or dimensions similar to previous disclosures and available to those of skill in the art. Nonetheless, for purpose of providing a full understanding, exemplary pores 597 are illustrated in partial form in overlay over the picture of the assembly made and shown in FIG. 23. [00188] In addition, in providing a full adjustable locking filter module such as module 595 in a delivery system, such as similar to that shown in FIG. 21 for example, a separately packaged guidewire is to be engaged within the guidewiare passageways of the various component parts in the delivery system. This is often to be accomplished by backloading a guidewire's proximal end into the delivery system's tip after already placing the guidewire's distal end in a desired region in the body for filtering. Accordingly, according to one further embodiment shown, guidewire member 591 is included that extends between transition ring 588 and distal tip 599 where it is secured beneath a terminal end of the pouch forming filter membrane 596. This inner guidewire member 591 allows for a guidewire to be backloaded through tip 599 and traverse through that member into the inner bore and guidewire passageway provided within lock 583 as retained by a retainer, and further through the delivery catheter assembly ultimately to exit the body, during loading and over the wire delivery of the filter module for deployment and locking over the guidewire in situ. In addition or in the alternative, as a further embodiment a disposable guidewire introducer may be loaded against, into, or through the tip of the assembly to provide a luminal passageway for guidewire loading, either retrograde or antegrade through the module delivery system, as described.

[00189] FIGS. 24A-C show side views of another embolic filter module in first, second, and third configurations, respectively, that correspond with first, second, and third modes of use, also respectively, when locked onto a guidewire in situ, and also incorporating a dynamic coupler between the lock and the filter assembly of an integral scaffold according to a further embodiment of the disclosure. These FIGS. 24A-C show still further aspects, modes, and embodiments of present invention that are also herein contemplated in context of a reference vessel or lumen.

[00190] More specifically, these views illustrate various modes of using an adjustable filter assembly 600 similar in many regards to many of the embodiments elsewhere herein described using adjustable locks onto guidewires. However, according to the present embodiment, the adjustable lock assembly 610 and adjustable filter member 650 are coupled together and engaged in a manner that provides for a range of motion between them when the filter member 650 is deployed within an artery and when the lock assembly 610 is locked onto a guidewire 660. This accomplished by a dynamic coupler

630 that allows for such relative motion, though within a range, the structure and use of which is described in further detail below.

[00191] It is highly undesired in the present setting of embolic filtration to release the filter assembly without an ability to retrieve it, and in particular to release it beyond a distal end of the guidewire. These are generally to be removed in some engaged fashion together. Accordingly, as the lock 610 is secured in place to the guidewire 660, the dynamic coupler 630 allows motion of the guidewire 660 to take place within a range without significant forces being felt at the filter assembly 650. This beneficially limits dragging motions of the filter assembly 650 against a vessel wall A, which may otherwise denude and possibly more seriously damage a vessel.

[00192] Accordingly, the dynamic coupler 630 shown in FIG. 24A is adapted to allow a range of relative longitudinal motion between the filter member 650 and the guidewire 660 about a resting point for the filter member 650. In the embodiment shown, this is done via a dynamic coupler 630 in the form of a spring, which extends longitudinally between distal end portion 614 of lock assembly 610 and proximal end portion 652 of filter member 650 relative to the guidewire 660. The resting condition is designated by reference to position "a" for distal end portion 614 of lock assembly 610. Position a is defined by a resting distance D1 across the resting spring to proximal end portion 652 of filter assembly 650 that is desirably to be relatively fixed with relatively little or no movement over the range of guidewire movement.

[00193] As the guidewire 660 moves proximally along the vessel during a procedure (FIG. 24B), the lock assembly 610 moves with it and without applying significant force on filter assembly 550 to move it from location A along the vessel wall. This takes place up to the point the lock assembly 610 and guidewire 660 move to point that distal end portion 614 of lock 610 is adjusted to position b (FIG. 24B) from resting position a (shown in shadow in FIG. 24B for reference). This results in an increased distance D2 from distal end portion 614 of lock 610 to proximal end portion 652 of filter member 650. This represents a range of motion of D2 minus D1. This distance represents a limit of "absorbed" motion by the spring as the spring has reached a longitudinal deflection force that transmits sufficient force to filter member 650 to invoke motion there. The dynamic coupler 630 thus does not allow for significant further relative motion and separation between the respectively coupled filter and lock components of the assembly beyond this point without moving the filter member 650 with that motion.

[00194] For further illustration, an opposite relative motion scenario with distally advancing guidewire 660 is illustrated in FIG. 24C, which shows guidewire 660 moving a distance limit of D1 -D3, wherein D3 represents the compression distance limit across the spring coupler 630 between the lock 610 and filter

650 components.

[00195] In one further highly beneficial embodiment, it is contemplated that the dynamic coupler is formed integrally from the same piece of material as the locking mechanism and the filter assembly. This is similar to that described elsewhere hereunder by reference to FIGS. 20A-C, wherein the dynamic coupler is given the form of a patterned spring structure cut into the nickel- titanium hypotube.

[00196] Various modes of patterning, processing, and training, may directly or indirectly impact the performance of such dynamic integral spring component in the assembly, as apparent to one of ordinary skill. In any event, one particular pattern for example is shown at assembly 690 in FIG. 25, which is shown in 2 dimensions as if the tubular member after patterning is cut longitudinally and laid flat on the page (eg. similar representation as FIG. 22), provided that certain structural features are shown schematically and thus without "widths" provided to such structures. Exemplary structures for lock assembly 610, dynamic coupler 630, and filter member assembly 650 are shown for further illustration and understanding. In the alternative to this particular spring design shown, other types of coiled springs, leaf springs, tethers, stretchable materials, etc. may be employed without departing from the broad intended scope of this particular aspect, which of particular benefit provides the ability to lock a filter assembly directly to a guidewire for unitary removal, but providing relative dynamic range of motion for the purpose of protecting vessel walls during active interventions and other procedures mechanically stressing the guidewire extending under or within the filter.

[00197] The provision of the present embodiments of FIGS. 24A-25 that forms all three components - lock assembly, dynamic coupler, and filter support scaffold - of unitary, integral construction from one piece of material is also of tremendous benefit, with reduced complexity and enhanced robust structure for improved safety. However, alternatives may also be employed including forming one or more of these components separately and then assembling them together, such as through welding, soldering, adhesive bonding, or other adjoining techniques apparent to one of ordinary skill.

[00198] FIGS. 26A-G show various schematic side views of an adjustable embolic filter module during sequential modes of use in an overall system and method for treating a chronic total occlusion while providing distal embolic protection according to a further embodiment of the present disclosure.

[00199] Additional aspects of invention also considered to provide significant benefit to improved medical care are illustrated in FIGS. 26A-G. These aspects provide significant benefit by leveraging the flexibility of the adjustable lockable filter assembly embodiments herein described to areas of interventional medicine where integrated filter wires are not desirable or even functional alternatives to a procedure. More specifically, this addresses procedures requiring specialty guidewires designed for other specified added benefit other than filtering, and thus mutually excluding filtering according to conventional options. [00200] This is in particular the case where specialty guidewires and/or related crossing systems are often required in order to cross chronic total occlusions. These often employ electrical, mechanical, or electro-mechanical actuators to apply some form of energy remotely to a guidewire distal tip when attempting to cross a tight occlusion remotely within the body. These actuators are typically located externally of the patient and transmit energy remotely to the tip, such as for example along the wire itself in the case of mechanically actuated wires propagating rotational, longitudinal, or other mechanical form of energy to the wire to enhance crossing. Other actuators may include for example electrical sources to generate a condition at the guidewire tip conducive to crossing. Either with or without actuators, sensors are also often employed that are coupled to a crossing wire or system to evaluate surrounding tissues and other environmental information within the body during a procedure for example.

[00201] Accordingly, FIG. 26A shows one particular embodiment of a chronic total occlusion (CTO) crossing system 700 that includes a mechanically actuated guidewire 710 with an elongated wire portion 712 with an enlarged distal tip portion 716. This guidewire 710 is provided in combination with an outer pilot lumen tissue ablation and/or atherectomy sheath 740, such that guidewire 710 is moveably engaged within a lumen 742 through sheath 740 to extend an adjustable distance distally from distal tip 746 of sheath 740. FIG. 18A shows this assembly during one mode of use at the proximal end or cap

704 of a chronic total occlusion CTO 702 prior to initiating crossing. An actuating system 750 includes two actuators 752,756 that are shown schematically, one being coupled to and actuating the guidewire 710, and the other coupled to and actuating the sheath 740. [00202] FIG. 26B shows this system 700 after successful crossing through the CTO 702 and into the distal lumen 706. FIG. 26C shows this system 700 during another sequential mode after withdrawal of the pilot lumen sheath 740 and leaving the specialty crossing wire 710 of the system 700 in place across the pilot lumen 708 formed through the lesion by outer ablative and/or atherectomizing sheath 740. [00203] As shown in FIG. 26D, an adjustable filter module 760 with an adjustable lock assembly 762 and adjustable filter assembly 766, such as for example according to one or more of the other present embodiments herein described, is advanced over this guidewire to a distal filtering location. Here it is locked to the actuated specialty wire 710 and deployed across the vessel in distal lumen 706 for filtering debris downstream of occlusion 702. The locked and deployed configuration is shown schematically in FIG. 26D.

[00204] Subsequent sequential steps of recanalization intervention by deploying a stent 770 to open the blockage 702 are shown in FIGS. 26E-F. While the particular embodiment shown provides a balloon 780 to expand stent 770, this is for illustration purposes and other deployable stents may be used such as for example of the self-expanding type (which may or may not be used in further conjunction with pressurized balloon inflations). In particular, as illustrated in FIG. 26F, debris is often released in this particular type of intervention, and in particular but without limitation for example in long CTO's of the peripheral vasculature, such as the legs (e.g. superficial femoral artery, etc.). According to the present illustrated embodiment, this debris is captured by the filter 760 locked on the CTO crossing wire 710. Retrieval and removal of the successfully used, in situ formed "filter wire," which includes the locked combination of filter 760 onto specialty guidewire 710, is illustrated in one mode in FIG. 26G.

[00205] It is to be appreciated therefore that the present aspect provides, in one regard, a therapeutic CTO system with distal embolic filtering capability. This system includes a crossing system, a recanalization system, and a filtering system, which all work in conjunction to provide a significant benefit to treating these very challenging and harmful conditions. It is to be appreciated, however, that by reference to such "system" (and other systems herein referenced), various sub-combinations of the various component parts are also contemplated, which may be independently beneficial either alone or by their ability to be later combined with other components. For example, the

CTO crossing system and embolic filter system may be considered beneficial in their own combination together. This allows for a number of different recanalization therapies to be chosen, while providing the access and distal protection desired. Moreover, the crossing wire of the CTO crossing system, or the pilot lumen sheath, may be provided in combination with the filter, which combination is beneficial by enabling later combination and use with the other omitted component. These combinations alone, though highly beneficial, are also illustrative of certain still broader aspects as combinations, including without limitation the following: (1 ) a deployable filter onto a guidewire that is provided in further combination with an actuator or sensor coupled to the guidewire; (2) the combination of (1 ) further including the additional feature of an enlarged tip on the guidewire; (3) an adjustable guidewire-lockable filter in combination with a guidewire with an enlarged distal tip.

[00206] For further example, as for aspect (1 ) noted immediately above, the deployable filter may be of the locking type, or of a "floating" type which does not lock onto the guidewire but is released to ride coaxially over the wire. In this regard, by further combination with aspect (2) above, this assembly has limited range of relative motion to allow removal together due to interference fit between the filter and an enlarged tip on the guidewire. This highly beneficial combination just described is considered to present special new benefit and utility, such as for example in the setting herein featured for filtering chronic total occlusion crossing and interventions.

[00207] It is to be appreciated that the various components of assembled combinations herein shown or described (and other components used in combination assemblies elsewhere herein described), may be packaged and/or sold either together, or they may be made available separately.

[00208] FIG. 27 shows another filter module embodiment providing an adjustable filter module similar to that illustrated in various regards by reference to FIGS. 22-23, including a similar nickel-titanium integral scaffold 582 and respective parts (as similarly referenced), except according to a further filter membrane embodiment of the disclosure. [00209] More specifically, the improved and beneficial filter module assembly 800 shown in FIG. 27 includes an inverted nose 812 of the filter member 810, which faces retrograde to a peak 814 arranged to be positioned substantially centrally within a body lumen where filtering is to be performed. As a result, debris encountered by the filter is diverted by the inverted nose-cone outward toward an annular pouch that is formed by and surrounding the inverted nose- cone. This shown for purpose of example by embolus 830 which flows along a tragectory shown by serial arrows 832 into filter 810, encounters nose 812, and is deflected radially outward to the annular pouch formed by the nose 812. [00210] It is generally well characterized and understood that fluid flow through luminal vessels proceeds with a variable velocity across the vessel. Velocity exactly at a wall is theoretically zero or very close to zero and stagnant, whereas highest flow is in the center of the vessel. A schematically representative distribution of flow vectors is illustrated by a series of coordinated arrows 840 for flow into filter 810, and arrows 846 for flow distally through filter 810, as shown in FIG. 27 for further illustration. Varied sizes of the individual arrows of these groups schematically represent a representative respective flow velocity at that arrow's location. While the magnitudes and/or relative difference in sizes of the arrows is not intended to represent any specific actual extent of or relative difference in flow distribution exactly, the illustration is provided for purpose of explaining the broad underlying basis of the intended environment of use and features of present embodiment. The particular variable velocity between these points is dependent upon various factors, such as fluid viscosity, size of the vessel, material properties of the vessel wall, etc. These aspects assume a given pressure drop longitudinally across a flow region, which if varied will also affect flow.

[00211] In the present embodiment, whereas the peak of the inverted nose cone is centered in the lumen at the "high flow" area, the debris is diverted to this annular pouch in a lower flow region at the wall. Accordingly, for a given amount of debris captured, the present embodiment should provide for superior flow properties through the filter as the high flow region remains largely unobstructed. This contrasts against other prior filters, which accumulate debris in the more central region of the vessel such as through a simple pouch design (such as previously hereunder described for the other embodiments). [00212] It is to be appreciated that the components shown in the picture of FIG. 27 include a guidewire lock assembly similar to the embodiment for lock 20 variously featured among the other present embodiments. This includes an with undulating strut pattern of nickel-titanium with opposite facing circumferentially oriented peaks along a length. This is formed integrally with a filter support scaffold loop which, in the physical embodiment shown in the picture, is formed from a nitinol tube that was laser cut. The inverted filter cone provides the inverted cone peak secured to the lock assembly and relatively fixed relative to the outer filter support scaffold which is a self- expanding loop where the annular pouch is secured. This manner of securing the outer pouch to the loop and the inner nose cone to (either directly or indirectly) an integral locking assembly is a highly beneficial particular embodiment that is robust, with few joints, efficient to manufacture, and high degree of repeatability as to the geometry and positioning of the respective parts during use. It is to be appreciated also that the specific embodiment shown in FIG. 27 provides the inverted nose 812 in relative fixed position relative to the other features of the assembly. This provides the benefit a robust repeatable mechanism for flow and debris diversion and capture not afforded to the same degree by a system providing for the inverted nose 812 in an adjustable mechanism, for example that inverts it in situ from a more traditional distally oriented pouch arrangement. However, in further embodiments, such adjustability may be considered beneficial for other considerations to consider in certain applications.

[00213] Certain broad aspects of the present disclosure are to be appreciated as particularly beneficial without necessary limitation by finer details of the embodiments herein shown and described. As such, the particular further benefits of such finer details are to be considered also broadly beneficial within such broad aspects, without requiring further combinations unless specifically so stated. Still further, however, each combination and sub-combination of the various aspects, modes, embodiments, features, and variations of the present disclosure apparent to one of ordinary is still further considered of additional individual value for beneficial use.

[00214] It is to be appreciated according to various of the present embodiments that an embolic filter system is provided that includes an over-the-wire filter assembly coupled to a delivery assembly. The filter assembly has a guidewire tracking assembly that is adapted to slideably engage a guidewire initially placed across a vascular occlusion and is advanced by the delivery assembly in the radially collapsed condition to slide or "shuttle" over the distally seated guidewire and follow the guidewire to the distal filtering location past the vascular occlusion. The filter assembly includes an adjustable lock assembly that is adjustable between an open position, which allows the filter assembly to shuttle over the guidewire, to a locked position, which locks the filter assembly onto the guidewire in situ at the distal location past a vascular occlusion. Once locked onto the guidewire, the filter is adjustable to the radially expanded condition and is detachable from the delivery assembly and thus becomes a part of the guidewire in-situ at the distal location. Thereafter the filter assembly is adapted to be withdrawn in unison with the guidewire and to be groomed into a captured configuration within a capture sheath. [00215] According to other aspects illustrated by various certain embodiments, a loop-shaped support member is housed within a circumferential passageway formed within a filter member wall. The support member is self-adjustable from a radially collapsed condition to a radially expanded condition that generally corresponds with radially collapsed and expanded configurations for the filter member wall. The support member is a memory alloy metal and self- adjusts to the radially expanded condition according to material recovery from a deformed condition of the material corresponding with the radially collapsed condition to a memory condition. The support member is adjusted to the radially collapsed condition within a radial constraint, such as within a delivery lumen of a delivery or guide sheath.

[00216] It is to be appreciated that certain present embodiments provide a beneficial ability to customize the position of a filter assembly along a guidewire, such as at a location along its length relative to other structures such as the distal guidewire tip. This allows the ability to customize the filtering location in reference to a desired placement of the guidewire tip in the body. Moreover, the filter may be used with a variety of different guidewires, such as stiffer, more flexible, varied tip shapes, varied diameter sizes, materials, etc. The physician is not required to use a particular guidewire provided with the filter. Thus, particular anatomical or procedural concerns specific to a patient intervention may be met with the ability to customize the filtering device. Still further, this arrangement nevertheless allows the guidewire and filter assembly to be integrated ex-vivo prior to the intervention, providing certain other benefits including for example the potential to achieve lower profiles than certain other "over-the-wire" filtering assemblies and techniques that track over a guidewire in-vivo.

[00217] Filter membranes herein referenced and described will typically include a wall that is substantially porous such that normal physiologic blood components flowing into a pocket formed by the membrane will pass through the wall, but whereas debris above a pre-determined dimension, such as from upstream (e.g. proximal relative to the filter module) interventions, will not pass and be captured within the pocket.

[00218] Filter support members described, such as loops or cages or "lantern" style arrays of splines, may be coupled to membranes in a variety of ways, including for example a loop support being coupled to an annular end of a material sheet forming the filter member in a variety of modes apparent to one of ordinary skill. The annular end in this approach may include a circumferential pouch formed by inverting or everting the end of the material sheet forming filter member on itself and then bonding the inverted or everted edge to the wall, such as by heat bonding, material welding, solvent bonding, adhesive bonding, stitching, etc. the loop-shaped support member may be positioned so as to be captured within the pouch as it is formed, or may be thereafter inserted therein, such as by leaving or forming un-bonded portions, e.g. apertures or ports into the pouch.

[00219] This all may be accomplished for example by forming the member initially as a flat sheet and providing a support member as a partial looped region between two opposite free wire ends. Such arrangement leaves two opposite openings to the inverted or everted pouch along an axis at the edge of the sheet transverse to a long axis of the sheet. One of the top opposite free wire ends is inserted into the pouch and strung therethrough until the partial loop-shaped region is positioned within the pouch. By bringing the free opposite ends together, they may be bonded either together or to the support spine or tubing. In this arrangement, such free ends may be in a bent orientation transverse to the plane of the radius of curvature for the intermediate loop located within the pouch. In any case, the opposite longitudinal edges of the sheet are also brought together to form the partial tubular member, and may be either bonded together or bonded to a spine to form the filter module. In this arrangement, the sheet may be either post- processed, or cut along a pre-arranged correlate pattern, that allows for the shaped taper toward the distal end which is rendered in a closed condition and secured to guidewire tracking and support spine (if provided).

[00220] Such memory condition and related memory shape herein described for certain structures of the embodiments, such as lock or filter support scaffolds, may correspond with the shape shown for the radially expanded or collapsed condition associated with intended uses described, or the memory shape may be something different and the structure is still under some constraint or deformation therefrom even in the condition illustrated. For example, the vessel wall itself may provide such restraint, and in fact such may allow for a range of lumens to be appropriately treated, as the filter support member under external wall constraint may have varied radially expanded conditions with shapes on planes with different angles transverse to the longitudinal axis of the lumen in order to span the cross section of different diameters of lumens.

[00221] The particular shape and arrangement of filter member embodiments are considered to be illustrative, though of particular contemplated benefit, and various other embodiments or variations are also contemplated. [00222] It is to be appreciated that further embodiments, such as dual filter support member embodiments along a filter membrane (not shown) vs. one loop for example, are illustrative of many different configurations that may be provided, such particular embodiment also provides certain particular beneficial results. In one regard, doubling the radially expanding support rings doubles the opportunity for the filter assembly to properly engage the respective lumen's wall, and thus to catch all desired large debris flowing therethrough. Where only one such structure is provided to engage the wall, its sizing may not be optimal. However, as vessels taper, having two spaced filters may provide benefit in certain circumstances. Moreover, they may be of equal size and/or shape, or they may be of different sizes and/or shapes, such as for example providing a distal support with a smaller circumference than a proximal support for a given filter, thus accommodating distally tapered lumens as described.

[00223] Various adjustable lock systems and methods are contemplated for providing the ability to lock an adjustable filter assembly at a selected location along a guidewire, and in particular for in-situ coupling, other than those specifically herein shown and described by reference to the Figures above.

[00224] An adjustable lock assembly, including without limitation of shapes and sizes herein shown and described, may be adapted for different types of actuation between conditions. Shape memory under changing temperatures may be used. Electrical, light, or other energy sources could be used to heat such shape memory structures. These are examples of the broad aspects herein contemplated.

[00225] Still other adjustable lock mechanisms are contemplated, including without limitation further examples that may be noted for further illustration of the broad intended scope of the present disclosure. [00226] Locks may vary as to their particular size, length, diameter, filament or strut pattern, or other relative dimensional or geometric shape characteristics. A given lock may vary within its own structure in such exemplary features. The relative location of such locks relative to other coordinating structures in overall combination assemblies may also vary. For example, a lock such as shown in FIG. 23, which extends proximally from a filter support scaffold in that embodiment, may be instead extended distally such as along the respective rotating arm that supports the open loop support, and possibly even internally within the membrane pouch. Providing a lock in this orientation provides a benefit to enable longer physical embodiments of the lock without compromising "landing zone", or the distance from the filter pouch mouth where a proximal interventional device advanced over the same guidewire is not allowed to further advance as it confronts the filter module. It is to be appreciated that the various discrete lock embodiments described, though considered highly beneficial, are illustrative an other configurations, shapes, sizes locations, numbers, or respective arrangements of locks are contemplated. As are the number of locking "elements" within a lock, such as crown peaks for example of a serpentine or other form of undulating filament provided in certain specific present embodiments. For example, a single discrete lock may suffice in certain arrangements. Such would simplify and reduce the cost of the overall arrangement, for example requiring only one actuator and/or retainer to operate the lock.

[00227] The provision of a selective lock assembly that provides for selective locking between a guidewire tracking filter assembly and the respectively tracked guidewire is thus to be considered broadly. Many different selective locks may be used, though particular herein contemplated are considered of particular benefit for various intended uses, as herein described and otherwise. However, notwithstanding certain particular embodiments, such locks may not be required for example to be integrated with the filter assembly itself. The lock may instead be a third assembly that cooperates with the guidewire and/or the filter assembly, or may be provided by the guidewire in a specialized design. However, by providing the lock other than by the guidewire, a wide variety of different guidewires may be used, providing substantial benefit to overall customization of procedures or to a treating physician's choices and techniques. [00228] It is further contemplated that the present embodiments may be readily adapted in delivery systems that are of a "rapid exchange" or monorail type, or may be full length over the wire type guidewire tracking systems. Notwithstanding certain specific portions of exemplary delivery systems herein shown and described in the particular embodiments, one or more typically a plurality of lumens are provided within such delivery systems within which are various coupling members having various functions and arrangements and functions, including as follows. One or more lumens arranged in series may provide a guidewire passageway in "rapid exchange" or "monorail" type of engagement, or full length over the wire. Other lumens may provide passageways for other devices such as actuators, pull members, fluid infusion or aspiration, etc. Such separate lumens may independently house such distinct component parts or functions over their entire effective length, or partially, and conversely in other arrangements certain lumens can house multiple parts and provide various different functions. [00229] Filter support scaffolds, though herein shown or described for the detailed embodiments in particular exemplary types, may take on various different configurations that would be apparent to one of ordinary skill, as would recapture systems and methods. For example, releasable tethers may be used to hold a filter assembly collapsed during delivery, and then release the assembly for self-expanding adjustment to an open filtering condition.

[00230] One or more markers may be provided for indicia of the relative location of an adjustable locking filter module along a guidewire during delivery. Such may also be provided on the filter delivery member for the purpose of providing indicia regarding the relative position of the delivery member with respect to the underlying filter member during deployment. The particular configurations herein shown for filter members are illustrative for clarity in the present embodiments, and other forms of filter members may be employed, such as for example various of the other embodiments herein described as would be appropriately applied here to one of ordinary skill in the art. Or, other filter assemblies otherwise known, anticipated or suggested, or otherwise obvious to one of ordinary skill may be suitably modified or applied to the present embodiments, such as adapting them to a lock as herein described and providing them in appropriate delivery systems for "anywire" guidewire guided delivery and adjustable guidewire locking for in situ integrated guidewire filtering use and removal. [00231] The "filter" assemblies herein referred to and by reference to the figures may incorporate various features and modes of operation and use of other previously disclosed filter assemblies, though modified according to various of the novel aspects herein described by illustration through the present embodiments. Examples of such acceptable filter materials and designs, in addition to various modes of use and in combination with other devices in overall medical treatment systems, are provided in the various documents herein incorporated by reference thereto.

[00232] Generally, various mechanical, electro-mechanical, or opto-mechanical modes may be used to adjust an embolic filtering module to alternatively slide or lock onto a guidewire. Several examples of additional embodiments not specifically shown in the Figures but contemplated include use of external energy source, such as a current source, coupled via a conductor to a portion of the filter device that acts as an electrode. The electrode, in monopolar embodiments, is coupled via the patient's tissues to a patch electrode to complete a circuit. Alternating RF frequency of sufficient amplitude will heat the electrode at the filter device to cause rise in temperature for shrinking down of a shape memory member to lock it onto the guidewire. The shape memory member may be the same member that serves as the electrode, such as a cuff, coil, or braid coupled to a support tube on which the filter assembly is secured. Various means for detaching such a conductor from the lock may be deployed as apparent to those of ordinary skill. However, for further illustration, such a conductor may be detachable from the lock or other heat generator associated with the assembly using a sacrificial electrolytic link between the wire and the adjustable member, in a similar arrangement for example as previously disclosed with respect to commercially available detachable embolic coils, such as to occlude AVM's, fistula's, or aneurysms.

[00233] Such further embodiments as just described, though not shown, are to be considered applicable as further embodiments of those shown. Moreover, other embodiments are contemplated. Bi-polar arrangements or "closed loop" electrical circuitry (e.g. resistance heating) can be used to electrically heat the material to cause the adjustment that locks the filter device onto the guidewire.

Other heating modes include ultrasound, light, thermal conduction, or other energy sources either integrated into the filter device itself, or coupled thereto.

For example, an ultrasound crystal coupled to the inner diameter of an outer radially confining sheath may be used to sufficiently heat the adjustable member for locking (not shown). Or, where electrical lead coupling is shown, a light fiber may be replaced to couple light energy such as laser or UV to the adjustable member to shrink it down or otherwise reshape it to cause the desired locking.

[00234] It is also to be appreciated that adjustable lock mechanisms utilizing heat shrink materials and modes may vary as to certain particular features.

For example, an adjustability along the entire length of a support tubular member may be adapted for locking onto the guidewire, whereas alternatively localized regions of radial adjustability for guidewire locking may be employed. Moreover, other modes than those shown among the embodiments may be used for locking, including for example radial or longitudinal mechanical forces to adjust shapes of various members, such as for example twisting or longitudinally tensioning a coil or braid to adjust the inner or outer diameter. In further modes not shown, locking may be achieved with local delivery of a small amount of adhesive, such as two-part component mixed in situ or within appropriate time of delivery before such "sets" for bonding. Or, a portion of plastic may be melted onto the guidewire to provide coupling with the respective filter member (or visa versa).

[00235] In another regard, an outer adjusting sheath may be provided separate from an energy coupling system that provides for the locking mechanism.

However, they may be considered separate parts of a cooperative control system that provides multiple functions to operate the filter device to provide medical care in combination with a guidewire and other inter-cooperating components. Such control system may include a more integrated assembly of component parts.

[00236] Embolic filter devices according to the present disclosure, and by reference to the various illustrative embodiments, may be constructed from various materials and to various dimensions as would be apparent to one of ordinary skill based at least in part upon review of this disclosure. However, for illustration, it is contemplated in particular embodiments that the filter devices may be adapted to operate over guidewires having outer diameters of 0.010", 0.014", 0.018", and 0.035". Moreover, kits of such devices may be provided, each being particularly adapted for use over a different sized guidewire, or each having the filter assembly being particularly adapted for use to filter blood flowing within arteries of varied dimensions.

[00237] Various references are herein made to "interventions" or interventional devices for use with the filter system(s) herein shown and described. While many more detailed examples are applicable and to be contemplated by one of ordinary skill, examples include angioplasty, stenting, and atherectomy devices and methods for recanalization of occlusions.

[00238] For purpose of further illustration, one mode of using certain of the present embolic filtering system embodiments is described as follows for a more complete understanding by reference to a recanalization procedure in a carotid artery occlusion.

[00239] Initially, a guidewire is placed using conventional techniques across the carotid artery occlusion, typically using a femoral or radial artery access technique with antegrade delivery to the occlusion site (often including use of a guiding catheter, and often an introducer sheath). A Seldinger technique may be used for example to provide such luminal access. Next, an embolic filter system is engaged over the guidewire by "back-loading" the guidewire through a guidewire lumen provided through a tubular support member of the embolic filter device. This is done with a radially confining sheath positioned over the embolic filter assembly to keep it in a radially collapsed and folded condition. The system is slideably advanced over the guidewire and across the occlusion site until the embolic filter device is located at a desired distal position for filtering. Then it is activated to lock it onto the wire in-situ at the distal position. Next, the assembly with radially confining sheath is withdrawn proximally to release the filter assembly from confinement, allowing shape memory of the assembly to expand it to an expanded configuration sufficient to span across a majority of the artery at the distal position for filtering. Where a coupling is provided directly to the embolic filter device for locking, e.g. via an electrical coupling lead, the coupler or lead is detached prior to proximal withdrawal. The various components of the control system may be withdrawn completely off from the guidewire, after which interventional device is replaced thereon and advanced to the occlusion for recanalization.

[00240] During the intervention, the filter is located and expanded to filter emboli released into downstream flow - this may also be left in place for sufficient time after intervention to catch further emboli.

[00241] In any event, when appropriate according to a treating physician, the filter assembly is adjusted back to a radially collapsed condition to capture the emboli filtered from the downstream blood flow. This may be done by again advancing a radially confining sheath over the wire and over the filter, such as by using the first control system a second time, or with a second outer sheath.

Or, a pull wire or multiplicity thereof may be used to pull down support member(s) supporting the filter assembly in the expanded configuration.

Depending upon the amount of emboli captured, all of the collapsed filter assembly may not be small enough to fit into an outer sheath, which case the entire system may need to be withdrawn over the guidewire and from the body. Otherwise, the collapsed filter may be withdrawn through the outer sheath, or filter and outer sheath together withdrawn within a guiding catheter guide lumen.

[00242] The various embodiments described hereunder are generally intended for use in overall embolic filtering systems intended to be used in cooperation with other devices to filter primarily emboli from blood flowing through vessels downstream from an intervention site. Certain reference is made to specific beneficial applications for the purpose of illustration, but such specified applications are not intended to be limiting. For example, reference to the embolic filters of the invention is often specified for use in distal filtering downstream from interventions as the most frequent type of filtering used in conventional interventions. However, other filters for all uses may be made according to the various embodiments herein described, including for example proximal filters. In addition, it is also contemplated that other regions of the body may be effectively filtered than those specifically described herein, such as other body lumens including for example veins, gastro-intestinal lumens, urinary tract lumens, lymph ducts, hepatic ducts, pancreatic ducts, etc. In addition, whereas many different filters may be used, the coupling of filters to guidewire tracking or locking chassis per the embodiments may be done by any conventional acceptable substitute modes. In addition, various locking mechanisms have been described for purpose of providing a detailed illustration of acceptable modes of making and using the embodiments herein featured in this disclosure. However, other locking modes may be employed without departing from the scope herein contemplated.

[00243] Where "proximal" or "distal" relative arrangements of components, or modes of use, are illustrated, other arrangements are contemplated though they may not be shown. For example, where various of the embodiments are adapted for antegrade use, they may be modified for retrograde delivery and use. In addition, proximal filtering may be accomplished according to the invention, such as by positioning a filter device proximal to an occlusion and using applied retrograde flow to wash emboli proximally into the filter. [00244] Various modifications may be made to the present embodiments without departing from the scope of the various aspects that are intended to be read as broad as possible with regard to the intended objectives described herein and to the extent providing unique benefit or aspects over what is already known in the art. Many examples of such modifications have been provided as illustrative and are not intended to be limiting, though significant value may be had in relation to certain such specific modifications or embodiments. Where particular structures, devices, systems, and methods are described as highly beneficial for the primary objective herein to provide adjustable embolic filters, other applications are contemplated both in medicine and otherwise in and out of the body. For example, various of the adjustable locking assemblies described may be found highly beneficial for use in locking other devices and assemblies over guidewires or other internal structures. In another example, an embodiment showing a guidewire with expandable member used to lock a filter thereon may be used to internally lock onto other outer coaxial structures.

[00245] Other applications may include adjustable annular collars used to lock down over centrally located devices extending within their bore, both within and outside of the medical field and arts. Another additional use for further illustration includes use of such adjustable locking members and related assemblies to graft two adjacent work pieces together, such as in a medical application to attach two pieces of bone together as a bone grafting tool.

[00246] It is to be appreciated that certain pictures provided within the Figures are provided for a more complete understanding of the various components elsewhere herein described by reference to illustrative drawings, in addition to other features that may be first introduced in the pictures themselves. Though a completed filter membrane is not included in certain assemblies featured in these pictures, it is apparent to one of ordinary skill that such step may be taken to complete a functional filtering assembly, such as for subsequent cleaning, sterilization, and use in filtering emboli from appropriate lumen(s) in which the deployed system is placed. Such steps are further contemplated aspects of the present disclosure.

[00247] Among other embodiments herein described, for purpose of further developing the breadth of certain aspects, a further embodiment for locking a filter module onto a guidewire contemplated for additional or alternative use versus other locks described provides a glue or adhesive that locks a filter assembly to a guidewire (not shown). Such a "glue" may be any injectable material that results in a locking between the filter assembly module and the guidewire, and may be glue in the classic sense with chemical adhesive bonding, or may create a mechanical interference such as filling the area between spaced coils of the guidewire and curing into a solid matrix that can not be moved relative to the wire. Biocompatible materials are desireable, such as for example fibrin glue, methacrylate, or alginate, or other form of "bioglues" or curable adhesives approved for use in the body. However, if delivery is contained well within a lumen with little to know harmful exposure to body tissue or fluids, strict biocompatibility may not be required for robust and safe results. Moreover, energy may be delivered to the area to enhance curing, such as UV light via a light fiber advanced through the needle or other delivery lumen coupled to the guidewire-support tube interface. Moreover, rather than injection of a curable material, such energy delivery may be employed to heat a material that flows (eg. by melting) or otherwise responds to fill the interface sufficient to lock the guidewire to the inner lumen of the filter support housing.

[00248] It is also to be appreciated that the glue may be a two-part adhesive system, such as for example fibrin glue or certain alginates noted above, that polymerizes or otherwise cures upon mixing the two (or more) parts involved in the setting of the adhesive. In this setting, a needle may be included such as with dual lumens that allow for separation of the components until they mix in situ, which may be expelled to mix either in gap area or lumen of an assembly or wire, or may include a mixing reservoir at the tip area of the needle. Various modes of multi-part polymer injection systems that have been previously described may be appropriately modified for use in this additional embodiment as apparent from the teachings of this disclosure. [00249] The present embodiments are in particular considered highly beneficial as herein described, whereas further combinations hereof with certain aspects of other disclosures are also considered of additional benefit and contemplated hereunder.

[00250] The various disclosures of the following PCT International Patent Publications are herein incorporated in their entirety by reference thereto: WO 2004/039287 to Peacock et al.; WO 2005/042081 to Peacock; WO 2006/084256 to Peacock; and WO 2007/035885 to Peacock. [00251] The following additional issued US Patents are herein incorporated in their entirety by reference thereto: 5,911 ,734 to Tsugita et al.; 6,027,520 to Tsugita et al.; 6,042,598 to Tsugita et al.; 6,168,579 to Tsugita; 6,179,859 to Bates et al.; 6,270,513 to Tsugita et al.; US 6,277,139 to Levinson et al.; and US 6,319,242 to Patterson et al.; 6,371 ,971 to Tsugita et al.; 6,537,295 to Petersen; 6,544,280 to Daniel et al.; 6,616,680 to Thielen; 6,616,681 to

Hanson et al.; 6,620,148 to Tsugita; 6,652,505 to Tsugita; 6,673,090 to Root et al.; 6,676,682 to Tsugita et al.; 6,902,572 to Beulke et al.; 6,939,361 to

Kleshinski.

[00252] The following additional International PCT Patent Application Publications are also herein incorporated in their entirety by reference thereto:

WO 00/67664 to Salviac Limited; WO 01/49215 to Advanced Cardiovascular

Systems, Inc.; WO 01/80777 to Salviac Limited; and WO 02/43595 to

Advanced Cardiovascular Systems, Inc.

[00253] Various combinations or sub-combinations of the features herein shown and described, and in addition as may be variously herein incorporated herewith by reference thereto or otherwise as may be apparent to one of ordinary skill, are to be made as apparent in reading this description in its entirety and with all the Figures combined.

[00254] As illustrated among the various present embodiments, a shaped structure is provided that is highly beneficial for a lock assembly for locking a filter assembly onto a guidewire. In particular, an undulating serpentine strut pattern propagates around an inner guidewire passageway with a series of opposite facing peaks in the pattern. This arrangement allows for the pattern to be readily "opened" as to the inner diameter of the guidewire passageway by spreading the adjacent opposite facing peaks apart from each other, as illustrated by way of example among the present embodiments. Various retention schemes are shown and described, whereas this particular pattern of design also allows for an interference member to prevent recovery down to the memory shape when placed within the bore of the structure when expanded, or in a circumferential gap between opposite facing peaks of the undulating structure formed by spreading the peaks apart. This general configuration and detailed exemplary embodiments stemming therefrom provides benefit in loading and unloading off of delivery assemblies, with highly trackable result with good transverse flexibility, but of significant radial integrity to lock down onto a guidewire in a robust manner with high strength to ensure securement. [00255] The various detailed descriptions of the specific embodiments may be further combined in many differing iterations, and other improvements or modifications may be made that are either equivalent to the structures and methods described or are obvious to one of ordinary skill in the art, without departing from the scope of the invention. The illustrative examples therefore are not intended to be limiting to the scope of the claims below, or with respect to the Summary of the Invention, unless such limitation is specifically indicated.

[00256] Although the description above contains many details, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention.

Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more." All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U. S. C. 112, sixth paragraph, unless the element is expressly recited using the phrase "means for."

Table 1

Exemplary Adjustable Locking Filter Module System Dimensions

Claims

CLAIMS What is claimed is:

1. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: an embolic filter module with an adjustable guidewire lock assembly and an adjustable filter assembly; wherein the adjustable guidewire lock assembly comprises a substantially tubular wall comprising an undulating pattern of shape memory strut material with an alternating series of opposite facing partial loop-shaped peaks along a length along a longitudinal axis and which peaks respectively face in alternating opposite directions transverse to the longitudinal axis; and wherein the substantially tubular wall defines an inner diameter around a guidewire passageway.

2. The system of claim 1 , wherein upon applied forces in opposite directions adjacent peaks may be spread apart relative to each other so as to expand the inner diameter at the location of the adjacent opposite peaks.

3. The system of claim 1 , wherein the filter module comprises an integral piece of material in a patterned shape along the lock assembly and filter assembly.

4. The system of claim 1 , wherein the substantially tubular wall comprises a nickel-titanium alloy tube material cut in the pattern.

5. The system of claim 3, wherein the patterned shape is cut from a nickel-titanium alloy tube.

6. The system of claim 4 or 5, wherein the patterned shape comprises the pattern of strut material along the lock assembly and a loop-shape filter support member along the filter assembly.

7. The system of claim 6, wherein the patterned shape comprises a lever arm extending between the lock assembly and the loop-shaped filter support member.

8. The system of claim 5, wherein the patterned shape comprises the pattern of strut material along the lock assembly and a lantern-shape filter support member with a series of circumferentially spaced longitudinal splines along the filter assembly.

9. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: a filter assembly comprising an adjustable filter wall that is adjustable between a radially collapsed configuration and a radially extended configuration; wherein in the radially collapsed configuration the filter wall has a first outer diameter and is adapted to be delivered to the location; wherein in the radially extended configuration the filter wall has a second outer diameter that is greater than the first outer diameter and sufficient to substantially span across a cross-sectional area of the lumen at the location and engage a wall of the lumen, and has a shape that forms a pouch adjacent an outer periphery of the area and to substantially divert emboli encountered by the wall to the outer peripheral pouch.

10. The system of claim 9, wherein the pouch is substantially annular around an outer circumferential region of the area and substantially surrounds an inner region of the wall that forms an inverted cone shape with a reducing taper diameter in the retrograde direction of fluid flow.

11. The system of claim 10, wherein the filter support scaffold comprises a loop shaped member coupled to the wall along the outer periphery, and the inverted cone shaped region is substantially fixed relative to the loop shaped member in the radially extended condition at the location.

12. The system of claim 9, wherein the filter assembly is deliverable over a guidewire by a delivery assembly to a position along the guidewire at the location.

13. The system of claim 12, wherein the filter assembly is detachable from the delivery assembly at the position.

14. The system of claim 13, wherein the filter assembly comprises an adjustable guideiwire lock assembly and is lockable at the position onto the guidewire at the location.

15. The system of claim 13, further comprising a guidewire with a radial enlargement on a distal end portion thereof, wherein the position is proximally of the enlargement, and the filter assembly is configured to float freely of the guidewire at the position, provided that upon proximal withdrawal of the guidewire relative to the filter assembly the enlargement mechanically confronts the filter assembly such that they may be thereafter withdrawn together upon further withdrawal force placed upon the guidewire.

16. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: an embolic filter module with an adjustable guidewire lock assembly and an adjustable filter assembly; wherein the adjustable guidewire lock assembly comprises a substantially tubular or quasi-tubular wall around a bore that extends along a longitudinal axis between two opposite open ends, and with a continual lateral passageway through the wall and extending between the two ends and that is bordered by first and second sides of the wall; wherein the wall comprises an elastic or superelastic material with a memory state in the radially collapsed and closed condition with a first inner diameter across the bore, and is deformable under an applied force to a radially expanded and open condition with a second inner diameter across the bore that is larger than the first inner diameter; and wherein the bore comprises a guidewire passageway.

17. The system of claim 16, wherein the first and second sides each comprises a port or aperture through the wall.

18. The system of claim 16, wherein the lateral passageway in the radially collapsed and closed condition comprises a patterned shape along the wall and that does not include a straight linear pathway between the first and second ends.

19. The system of claim 18, wherein the patterned shape comprises an undulating pattern with a series of alternating opposite facing peaks that face each other transverse to the longitudinal axis.

20. The system of claim 18, wherein the lateral passageway in the radially expanded and open condition comprises a straight linear pathway extending between the first and second ends and with a minimum diameter D between the first and second sides.

21 . The system of claim 16, further comprising: an adjustable retainer that is adjustable between first and second positions relative to the lock and corresponding with the radially expanded and open condition and the radially collapsed and closed condition for the lock, respectively; wherein the first position is located within either the bore or the lateral passageway and is configured to retain the lock in the radially expanded and open condition; wherein the second position is located outside of each of the bore and the lateral passageway; wherein the retainer is adjustable from the first position to the second position by moving the retainer relative to the lock via a remotely manipulated actuator; and whereby adjusting the retainer from the first position to the second position the lock is released from retention in the radially expanded and open condition and allowed to recover under elastic or superelastic material recovery force toward a memory condition and to the radially collapsed and closed condition.

22. The system of claim 21 , wherein the retainer is adjustable from the first position to the second position by proximal withdrawal of the retainer along the longitudinal axis relative to a mechanical interference against a proximal withdrawal of the lock.

23. The system of claim 21 , wherein: the retainer comprises an inner retainer tube with an elongated tubular wall with an outer surface and inner passageway that is located at least in part along the bore in the first position; the lock is retained in the radially expanded and open condition outside and at least partially around the outer surface in the first position for the retainer.

24. The system of claim 23, wherein the lock is seated on the outer surface of the tubular wall in the first position with an inward force of material recovery toward a memory condition from the elastically or superelastically deformed material in the radially expanded and open condition.

25. The system of claim 23, wherein the retainer comprises a stand-off from the outer surface that is located within the lateral passageway and with first and second edges in confronting engagement with the first and second sides of the lock's wall in the first position.

26. The system of claim 21 , wherein the retainer is located within the lateral passageway and comprises first and second edges in confronting engagement with the first and second sides of the lock's wall in the first position, such that the retainer provides a mechanical interference against the first and second sides recovering toward each other in the elastically or superelastically deformed radially expanded and open condition.

27. The system of claim 26, wherein the retainer comprises an interior stand-off from an outer tubular member that in the first position is located externally around the lock in the open condition but for the retainer located in the lateral passageway.

28. The system of claim 26, wherein the retainer comprises at least one recessed groove within one of the retainer's edges that is configured to receive at least a portion of a corresponding side of the lock's wall for enhanced retention of the lock in the open condition.

29. The system of claim 1 or 16, further comprising: a dynamic coupler located between the filter assembly and the lock and providing for a limited range of motion between the filter assembly when deployed within a lumen for filtering and the lock when locked onto a guidewire in the lumen.

30. The system of claim 29, wherein the dynamic coupler comprises a tether, thread, or filament.

31. The system of claim 29, wherein the dynamic coupler comprises a spring.

32. The system of claim 29, wherein the dynamic coupler is formed integrally with the lock and a filter support member of the filter assembly from one piece of material.

33. The system of claim 32, wherein the piece of material comprises a wire filament wound into a pattern.

34. The system of claim 32, wherein the piece of material comprises an elastic or superelastic tube.

35. The system of claim 29, wherein at least one of the lock, filter assembly, and dynamic coupler comprises a separate part secured to another of the lock, filter, and dynamic coupler.

36. The system of claim 16, wherein the lock and the filter assembly are formed integrally with each other from one piece of material.

37. The system of claim 16, wherein the lock and the filter assembly are separate parts coupled together.

38. The system of claim 1 or 16, further comprising: a delivery system configured to deliver the lock and filter assembly to a location over a guidewire in a body of a patient.

39. The system of claim 1 , 9, or 16, further comprising: a guidewire configured to provide a rail for delivering the filter assembly to a location in a body of a patient.

40. The system of claim 1 , 9, or 16, further comprising: an interventional device system configured to perform an intervention adjacent to the filter assembly in a body of a patient.

41. A system for releasably adjusting a radially adjustable tubular or quasi- tubular lock between a radially collapsed and closed memory condition with a first inner diameter and a superelastically or elastically deformed radially expanded and open condition with a larger second inner diameter, comprising: an adjustable lock with a tubular or quasi-tubular wall around a bore that extends along a longitudinal axis between two opposite open ends, and with a continual lateral passageway through the wall and extending between the two ends and that is bordered by first and second sides of the wall; wherein the wall comprises an elastic or superelastic material with a memory state in the radially collapsed and closed condition with the first inner diameter across the bore, and is deformable under an applied force to a radially expanded and open condition with a larger second diameter across the bore; an expansion assembly with at least first and second adjustable pull members; wherein the first pull member is configured to releasably engage the first side; wherein the second pull member is configured to releasably engage the second side; wherein the first and second pull members are configured to transmit a pull force under tension to the respectively engaged first and second sides sufficiently to spread the first and second sides apart to thereby expand a distance therebetween to broaden the lateral passageway and deform the wall into the radially expanded and open condition with the larger second diameter across the bore; and wherein the first and second pull members are configured to release the first and second sides, respectively, in the radially expanded and open condition to allow the lock to recover under elastic or superelastic memory recovery force to the radially collapsed and closed condition.

42. The system of claim 41 , further comprising: a retainer assembly with a retainer that is adjustable between first and second positions relative to the lock at a location; wherein the first position is located within at least one of the bore and the lateral passageway and retains the lock substantially in the open condition; wherein the second position is located outside of the bore and lateral passageway of the lock's wall; wherein the retainer is adjustable to the first position while the lock's wall is adjusted to the radially expanded and open condition by the expansion assembly; wherein the retainer in the first position is configured to retain the lock in the radially expanded and open condition after it is released by the expansion assembly; and wherein the retainer is adjustable from the first position to the second position relative to the lock by providing moving the retainer relative to the lock via an actuator.

43. The system of claim 41 , further comprising: at least a third pull member; at least two locations on the first side of the lock's wall bordering the lateral passageway and configured to be engaged by each of the first and third pull members; and wherein the first and third pull members are configured to engage the two locations for pulling the first side apart under applied tension from the second side engaged and pulled by the second pull member.

44. The system of claim 43, wherein the first and third pull members are coupled to a fixture providing coordinated positioning and movement between them.

45. The system of claim 44, wherein the first and third pull members comprise extensions from a common piece of material.

46. The system of claim 43, further comprising: at least a fourth pull member; at least two locations on the second side of the lock bordering the lateral passageway and configured to be engaged by each of the second and fourth pull members; and wherein the first and third pull members are configured to engage the two locations on the first side for pulling the first side away from the lateral passageway; and wherein the second and fourth pull members are configured to engage the two locations on the second side for pulling the second side away from the lateral passageway.

47. The system of claim 46, wherein: the first and third pull members are coupled to a fixture providing coordinated positioning and movement between them; and the second and fourth pull members are coupled to a fixture providing coordinated positioning and movement between them.

48. The system of claim 47, wherein: the first and third pull members comprise extensions from a first common piece of material; and the second and fourth pull members comprise extensions from a second common piece of material.

49. The system of claim 41 , wherein the first and second pull members are coupled to a fixture to provide coordinated movement between them for pulling with tension on the respectively engaged lock wall.

50. The system of claim 41 , 43, or 46, wherein each respective pull member comprises a tether, wire, thread, or filament configured to loop around an aperture, wire filament, or other feature provided along the respective side of the lock's wall.

51. The system of claim 41 , 43, or 46, wherein each respective pull member comprises a tension member with a hook configured to engage a mating location along the respective side of the lock's wall.

52. The system of claim 51 , wherein the hook comprises a feature to at least partially enclose a portion of the wall engaged by the hook.

53. The system of claim 43 or 46, wherein: at least the first side of the lock comprises two locations of predetermined relative positions for engagement with the first and third pull members; and the first and third pull members are provided in a fixture at two locations of predetermined relative positions between them and corresponding with the positions of the two locations for coordinated engagement with the first and third pull members.

54. The system of claim 53, wherein the fixture is configured to pull the first and third pull members laterally.

55. The system of claim 53, wherein the fixture is configured to pull the first and third pull members along an arcuate path.

56. A method for releasably adjusting a radially adjustable tubular or quasi- tubular lock between a radially collapsed and closed memory condition with a first inner diameter and a superelastically or elastically deformed radially expanded and open condition with a larger second inner diameter, comprising: providing an adjustable lock with a tubular or quasi-tubular wall around a bore that extends along a longitudinal axis between two opposite open ends, and with a continual lateral passageway through the wall and extending between the two ends and that is bordered by first and second sides of the wall; wherein the wall comprises an elastic or superelastic material with a memory state in the radially collapsed and closed condition with the first inner diameter across the bore, and is deformable under an applied force to a radially expanded and open condition with a larger second diameter across the bore; providing an expansion assembly with at least first and second adjustable pull members; releasably engaging a first side of the lock's wall with the first pull member; releasably engaging the second side of the lock's wall with second pull member; and applying tension to the first and second pull members in a manner that transmits a pull force to the respectively engaged first and second sides sufficiently to spread the first and second sides apart to thereby expand a distance therebetween to broaden the lateral passageway and deform the wall into the radially expanded and open condition with the larger second diameter across the bore.

57. The method of claim 56, further comprising: releasing the first and second pull members from the first and second sides, respectively, in the radially expanded and open condition to allow the lock to recover under elastic or superelastic recovery force to the radially collapsed and closed condition.

58. The method of claim 57, further comprising: providing a retainer assembly with a retainer that is adjustable between first and second positions relative to the lock; wherein the first position is located within at least one of the bore and the lateral passageway and retains the lock substantially in the open condition; wherein the second position is located outside of the bore and lateral passageway of the lock's wall; positioning the retainer in the first position while the lock's wall is adjusted to the radially expanded and open condition by the expansion assembly; releasing the first and second pull members from the first and second sides of the lock's wall while the retainer is located in the first position; retaining the lock in the radially expanded and open condition with the retainer in the first position after the lock is released by the expansion assembly; and adjusting the retainer from the first position to the second position relative to the lock by moving the retainer relative to the lock via an actuator, thereby releasing the lock from retention in the radially expanded and open condition and allowing it to recover with elastic or superelastic memory recovery force to the radially collapsed and closed condition.

59. The method of claim 58, further comprising: providing at least a third pull member; engaging at least two locations along the first side of the lock's wall bordering the lateral passageway by each of the first and third pull members; and applying tension to the first and third pull members to pull the first side apart from the second side engaged and pulled by the second pull member.

60. The system of claim 59, further comprising: coordinating relative positioning and movement between the first and third pull members via a fixture.

61. The system of claim 59, further comprising providing the first and third pull members as extensions from a common piece of material.

62. The system of claim 59, further comprising: providing at least a fourth pull member; engaging at least two locations along the second side of the lock's wall bordering the lateral passageway by each of the second and fourth pull members; applying tension to the first and third pull members engaged with the two locations on the first side to pull the first side away from the lateral passageway; and applying tension to the second and fourth pull members engaged with the two locations on the second side to pull the second side away from the lateral passageway.

63. The method of claim 62, further comprising: coordinating relative positioning and movement between the first and third pull members with a fixture; and coordinating relative positioning and movement between the second and fourth pull members with a fixture.

64. The method of claim 63, further comprising: providing and manipulating the first and third pull members as extensions from a first common piece of material; and providing and manipulating the second and fourth pull members as extensions from a second common piece of material.

65. The method of claim 56, further comprising: coupling the first and second pull members to a fixture; and providing coordinated movement between the first and second pull members to pull with tension on the respectively engaged lock wall.

66. The method of claim 56, further comprising looping the pull member that comprises a tether, thread, or wire filament through an aperture, wire filament, or other feature along the respective lock wall.

67. The method of claim 56, further comprising hooking an aperture, wire filament, or other feature along the respective lock wall with a pull member that comprises a hook on an end of a tension member.

68. The method of claim 66 or 67, further comprising securing a first end of the pull member looped or hooked through the aperture, wire filament, or other feature along the respective wall relative to a second end extending from the feature prior to pulling on the wall.

69. The method of claim 59 or 62, further comprising: providing the first side of the lock wall with at least two locations of predetermined relative positions for engagement with the first and third pull members; and providing the first and third pull members in a fixture at two locations of predetermined relative positions between them and corresponding with the positions of the two locations for coordinated engagement with the first and third pull members.

70. The method of claim 69, further comprising pulling the first and third pull members laterally relative to the lock with the fixture.

71. The method of claim 69, further comprising pulling the first and third pull members along an arcuate path relative to the lock with the fixture.

72. A method for providing an adjustable lock in a delivery system for delivering the lock over a guide member to a location in a patient's body and locking the lock onto the guide member at the location, comprising: providing the lock with an elastic or superelastic tubular or quasi tubular wall structure around a bore that extends along a longitudinal axis between two open ends and with a continuous lateral passageway through the wall between the first and second ends and with first and second sides of the wall bordering the lateral passageway, wherein the wall is adjustable between a radially collapsed and closed condition and an elastically or superelastically deformed radially expanded and open condition; adjusting the lock to the radially expanded and open condition by spreading the first and second sides of the wall apart relative to the passageway; positioning an adjustable retainer in a first position within at least one of the bore or the lateral passageway while the lock is in the radially expanded and open condition; and retaining the lock in the radially expanded and open condition by the retainer; wherein the lock is configured to slideably engage a guide member through the bore and track over the guide member to the location with the retainer in the first position; and wherein the retainer is adjustable at the location from the first position to a second position that is outside of the bore and lateral passageway to thereby release the lock for recovery toward the radially expanded and closed condition for locking engagement over the guide member at the location.

73. A method for delivering an adjustable lock in a delivery system over a guide member to a location in a patient's body and for locking the lock onto the guide member at the location, comprising: providing a lock with an elastic or superelastic tubular or quasi tubular wall structure around a bore that extends along a longitudinal axis between two open ends and with a continuous lateral passageway through the wall between the first and second ends, and with an adjustable retainer located in a first position within at least one of the bore or the lateral passageway to thereby retain the lock in a radially expanded and open condition with a first inner diameter across the bore; and slideably engaging a guide member through the bore and tracking the lock and retainer assembly over the guide member to the location with the retainer in the first position; and adjusting the retainer at the location from the first position to a second position that is outside of the bore and lateral passageway, thereby releasing the lock from retention and allowing the lock to recover under elastic or superelastic material memory recovery force toward the radially collapsed and closed condition and that locks the lock over the guide member at the location.