WO2007035885A2

WO2007035885A2 - Embolic filter device and related systems and methods

Info

Publication number: WO2007035885A2
Application number: PCT/US2006/036857
Authority: WO
Inventors: James C. Peacock, Iii
Original assignee: Emerge Medsystems, Llc
Priority date: 2005-09-20
Filing date: 2006-09-20
Publication date: 2007-03-29
Also published as: EP1937348A2; WO2007035885A3; JP2009508657A

Abstract

An adjustable embolic filter module includes an adjustable lock assembly and an adjustable filter assembly with a filter support scaffold and filter member. The lock assembly and filter support scaffold are formed integrally from one piece of nickel-titanium tubing that is cut and retrained into a shape memory pattern. The lock assembly locks onto a guidewire, and the adjustable filter assembly self-expands when released from radial compression to filter blood at the location. A delivery system provides low profile delivery and release of the assembly for guidewire locking and filter deployment. A dynamic coupling is positioned between the lock and the filter, allowing limited range of motion between them upon movement of the locked guidewire. A system includes an actuated or sensed guidewire in combination with an adjustable filter module. A guidewire-lockable filter includes a needle coupled into the guidewire lumen for energy or material delivery to lock the filter to the guidewire.

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. 60/719,303 filed on September 20, 2005, 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 filtering emboli from fluid flowing through a body lumen in a patient. 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] Various needs still exist in clinical medicine for improved embolic filtering systems, including without limitation the following needs. [0010] A need still exists for an 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. [0011] A need 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. [0012] 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. [0013] 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. [0014] 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 and loaded onto an adjustable inner sheath to hold the tubular structure to a radially open diameter and expanded condition and shape 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.

[0015] 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

[0016] One aspect of the present disclosure is an embolic filter system that includes an embolic filter device that is adapted to be used over a guidewire such that the guidewire is provided independent of the filter system, though the filter device cooperates with the guidewire.

[0017] Another aspect of the present disclosure is an adjustable filter assembly that can track over a separate guidewire to a location within a patient's body, and to reliably and efficiently lock onto the guidewire at the location to thereby form in situ a filter wire that includes the locked combination of the filter assembly and the guidewire. [0018] Another aspect is an adjustable lockable filter assembly that is efficiently manufacturable.

[0019] Another aspect is an adjustable lockable filter assembly that is adapted to be manufactured at low cost.

[0020] Another aspect is an adjustable lockable filter assembly that is adapted to be manufactured with few parts or joints formed between parts. [0021] Another aspect is an adjustable lockable filter assembly that includes a filter membrane support scaffold and a guidewire lock assembly that are formed integrally from one piece of material.

[0022] Another aspect is an adjustable lockable filter assembly that is designed for easy and efficient clinical use. [0023] Another aspect is an adjustable lockable filter assembly that is provided for relatively low profile delivery over a guidewire to a filter location where a filter wire may be formed in situ by locking the filter assembly onto the guidewire. [0024] Another aspect is an improved delivery assembly for an adjustable lockable filter assembly that enhances one or more of the following: delivery over a guidewire to a filter location, locking onto the guidewire, release of an expandable filter member from radial confinement for filtering within the lumen, and removal of the filter assembly from the delivery system once locked onto the guidewire. [0025] According to another aspect, an embolic filter device is adjustable between a first configuration and a second configuration, and also between unlocked and locked conditions with respect to the guidewire. In the first configuration and unlocked condition, the embolic filter device is adapted to be slideably positioned over a guidewire at a position where filtering is desired. The filter device is adapted to be adjusted to the locked condition onto the guidewire at the position. The filter device is further adapted to be adjusted in-vivo to the second configuration that is adapted to filter emboli from fluids flowing therethrough at a filtering location corresponding to the filter device's locked position along the guidewire. [0026] In one mode of this aspect, the filter device is adapted to filter emboli from blood. [0027] In one embodiment of this mode, the device is adapted to be positioned with the guidewire at a location downstream from an intervention site. In one further embodiment, the location is in a carotid artery in a patient and to filter emboli released during the intervention at the intervention site. In another further embodiment, the filter system is adapted to be positioned downstream from an anastomosed arterial or venous graft, and is adapted to filter emboli from blood flowing downstream from the graft, such as during an intervention such as recanalization of the graft. [0028] In another mode of the present aspect, the filter device has a filter assembly secured onto a substantially tubular support member. The tubular support member has a guidewire passageway therethrough and is adjustable between a first configuration and a second configuration. In the first configuration the guidewire passageway has a first inner diameter that is adapted to allow the tubular support member to be moveably engaged over the guidewire for adjustable placement of the filter device along the length of the guidewire. In the second configuration, the guidewire passageway has a second inner diameter that is adapted to engage the guidewire sufficient to lock the filter device onto the guidewire such that the filter device remains on the guidewire during in-vivo use. [0029] In another mode of the present aspect, the filter device adjusts to the second configuration in response to an applied energy. In one embodiment, the filter device is adapted to adjust to the second configuration in response to an applied electrical current to a conductor associated with the filter device. In another embodiment, the filter device is adapted to adjust to the second configuration in response to applied ultrasound energy. In another embodiment, the adjustment is in response to an applied light energy. In another embodiment, the applied energy comprises thermal energy. [0030] In another mode of the present aspect, the filter system includes a control system coupled to the filter device and that is adapted to control the positioning, locking, and radial adjusting of the filter device with respect to a guidewire.

[0031] According to one embodiment of this mode, the control system includes a delivery member that is adapted to hold the filter device and advance the filter device over a guidewire to the position where it is desired to be locked. In another embodiment a lock member is controlled by the control system and is adapted to lock the filter device at the position along the guidewire. [0032] In another embodiment, the control system includes a radial adjusting system that is adapted to couple to the filter device and adjust it between the first and second configurations. In one variation of this embodiment, the radial adjusting system includes an outer sheath that is longitudinally moveable over the guidewire between first and second positions, respectively, with respect to the filter device. In the first position, the filter device is radially contained within a passageway of the outer sheath in a radially collapsed condition. In the second position, the filter device is located exteriorly of the passageway and is adapted to expand to a memory state that is a radially expanded condition corresponding to the second configuration. In another variation, a pull wire is coupled to a radial support member. [0033] In another aspect of the present disclosure, an embolic filter system is provided with a filter device that includes a filter assembly with a radial support member coupled to a filter wall. In a radially expanded condition, the radial support member supports at least in part the filter wall in a shape that is adapted to filter blood flowing into the assembly of the radially support member and wall.

[0034] In one mode of this aspect, the filter wall is a sheet of material. In one embodiment, the sheet of material comprises a porous membrane with pores having sufficient size to allow normal physiological blood components to pass therethrough, but to filter larger components such as emboli from passing. In another embodiment, the sheet of material has a plurality of apertures formed therethrough. [0035] In another mode, the filter wall includes a meshed network of strand material having spaces between strands of sufficient size to allow normal physiological blood components to pass therethrough, but to filter larger components such as emboli from passing.

[0036] Another aspect of the present disclosure provides an embolic filter system having an embolic filter device coupled to a control system that includes at least one detachable member that is detachable from the embolic filter device when the embolic filter device is positioned at a remote in-vivo location. [0037] In one mode of this aspect, the detachable member is a conductor lead that is adapted to couple energy from an ex-vivo energy source to the embolic filter device at the remote in-vivo location. In one embodiment of this mode, the conductor lead is electrolytically detachable from the filter device upon application of sufficient electrical energy to a sacrificial link between the conductor lead and the filter device. [0038] Another aspect of the present disclosure provides an embolic filter system with an embolic filter device that includes a filter assembly coupled to a locking member. The locking member is adjustable between an unlocked condition and a locked condition. In the unlocked condition, the filter device is adapted to be advanced over a guidewire to a desired position. In the locked condition, the filter device is substantially locked onto the guidewire at the position. [0039] Another aspect of the present disclosure provides an embolic filter system with an embolic filter device that includes a filter assembly cooperating with an adjustable member. The adjustable member is adjustable between a first shape and a second shape. In the first shape the adjustable member is configured to allow for passage of a guidewire therethrough. In the second shape, the filter device is adapted to be locked onto the guidewire. [0040] In one mode, the adjustable member has a first inner diameter in the first shape, and a second inner diameter that is smaller than the first inner diameter in the second shape.

[0041] In another mode, the adjustable member is formed at least in part from a shape-memory material. In one embodiment, the shape memory material is nickel-titanium alloy. In one variation, the nickel-titanium alloy forms an annular member such as a ring. In a further feature, the ring may have a memory state in the second shape. In a further feature, the ring is adjustable between the first and second shapes at a particular temperature. In a further feature, the temperature is above normal resting body temperature. In another mode, the adjustable member comprises a superelastic material that superelastically recovers to a memory shape upon release from an applied force that superelastically deforms the material from the memory shape to an adjusted shape. [0042] In another mode, the adjustable member is adapted to be positioned along the guidewire and has a first outer diameter in the first shape and a second outer diameter in the second shape. The first outer diameter is sufficiently small to allow slideable clearance between the guidewire at the position of the adjustable member and a guidewire passageway of the filter device. The second outer diameter is larger than the first outer diameter and is sufficient to radially engage the guidewire passageway to thereby lock the filter device onto the guidewire at the position of the adjustable member.

[0043] Another aspect of the present disclosure provides an embolic filter system with an embolic filter device having a filter assembly cooperating with an annular member that is adjustable between first and second inner diameters. The first inner diameter is greater than an outer diameter of the guidewire. The second inner diameter is less than the outer diameter of the guidewire.

[0044] In one mode, the annular member is formed at least in part from a shape-memory material. In one embodiment, the shape memory material is nickel-titanium alloy.

[0045] In another mode, the annular member is a ring.

[0046] In another mode, the annular member is a coil.

[0047] In another mode, the annular member is a tubular member. [0048] In another mode, the annular member comprises a pattern of interconnected struts separated by void areas.

[0049] In another mode, the annular member is formed at least in part from a solid tubular member that has a pattern of voids cut therein. [0050] In another mode, the annular member has a memory condition in the second shape. In one embodiment, the annular member is adjustable between the first and second shapes at a transition temperature. In one variation, the transition temperature is above normal resting body temperature. In another variation, the transition temperature is equal to about normal resting body temperature. [0051] In another mode, the annular member comprises a superelastic material that superelastically recovers to a memory shape upon release from an applied force that superelastically deforms the material from the memory shape to an adjusted shape.

[0052] Another aspect of the present disclosure is a method for providing an embolic filter system, comprising providing an embolic filter device; placing a distal end portion of a guidewire at a remote in-vivo location within a body of a patient; advancing the filter device over the guidewire in a first configuration and unlocked condition to a position along the distal end portion of the guidewire where filtering is desired; locking the filter device onto the guidewire by adjusting the filter device from the unlocked condition to the locked condition at the position; and adjusting the locked filter device at the position from the first configuration to the second configuration that is adapted to filter emboli from fluid flowing into the filter.

[0053] According to one mode of this aspect, the method further includes heating the filter device at the position by coupling the filter device to an energy source located externally from the body; and wherein the heat adjusts the filter device from the unlocked condition to the locked condition. In a further embodiment, the heating includes applying an electrical current to a conductor associated with the filter device, and in one variation the method includes applying an RF current to the conductor. In another embodiment, the heating includes optically coupling light to a conductor associated with the filter that is adapted to heat upon absorbing the light. In another embodiment, the heating includes coupling ultrasound energy to a conductor associated with the filter device that is adapted to heat upon ultrasound absorbance. The ultrasound energy may be produced within the system itself within the body, such as by coupling an ultrasound crystal associated with the filter device with an electrical source externally of the body that is adapted to energize the ultrasound crystal to produce the ultrasound energy. [0054] According to another mode, a superelastic material is adjusted between a memory condition and a superelastically deformed condition. According to one embodiment, the material is a nickel-titanium alloy material. [0055] Another mode of this aspect includes adjusting an adjustable member of the filter device from a first shape to a second shape that correspond with the unlocked and locked conditions, respectively, for the device. In the first shape, there is clearance for the filter device to slideably engage and move over the guidewire. In the second shape, the adjustable member engages the guidewire. In one embodiment the adjusting includes reducing the inner diameter of an annular ring. In another embodiment, the adjusting includes reducing the inner diameter of a longitudinally extending coil or braid.

[0056] Another aspect of the present disclosure provides an embolic filter as a module that is adapted to be removably engaged onto a guidewire. [0057] Another aspect of the present disclosure provides an embolic filter that is adapted to be delivered over an indwelling guidewire, positioned at a location along a distal end portion of the guidewire distal to a site of intervention, and locked onto the guidewire at the location.

[0058] Another aspect of the present disclosure provides an embolic filter that is adjustable between radially collapsed and radially expanded conditions on a guidewire positioned at a location distal to an intended invention site. [0059] Various additional aspects of the present disclosure include adaptations of the aspects, modes, embodiments, variations, and features elsewhere herein described as a proximal embolic filtering system and method. [0060] Another aspect of the present disclosure is an embolic filter system with a filter assembly and an adjustable lock assembly as follows. The filter assembly has a filter member that is adjustable between a radially collapsed configuration and a radially expanded configuration. The filter assembly is adapted to be locked with the adjustable lock assembly at a selected position along a distal end portion of a guidewire at a location within a lumen in a patient's body, and is adapted to be delivered at least in part with the guidewire to the location in the locked configuration. The filter member is adjustable at the location from the radially collapsed configuration to a radially expanded configuration that spans across a substantial cross-section of the lumen. The filter member in the radially expanded configuration at the location is also adapted to filter components of fluid flowing through the lumen at the location above a predetermined size. [0061] Another aspect of the present disclosure is an embolic filter system with a delivery member that cooperates with a filter assembly as follows. The delivery member has an elongate body with a proximal end portion and a distal end portion. The filter assembly has a filter member that is adjustable between a radially collapsed configuration and a radially expanded configuration. The distal end portion of the delivery member is coupled to the filter assembly and is adapted to at least in part advance the filter assembly in the radially collapsed configuration to a location within a lumen in a body of a patient by manipulating the proximal end portion externally of the patient's body. The filter member is adjustable at the location from the radially collapsed configuration to a radially expanded configuration that spans across a substantial cross-section of the lumen. The filter member in the radially expanded configuration at the location is adapted to filter components of fluid flowing through the lumen at the location above a predetermined size. The distal end portion of the delivery member is detachable from the filter assembly at the location.

[0062] Another aspect of the present disclosure is an embolic filter system with a delivery member, a filter assembly, and an adjustable lock assembly as follows. The delivery member has an elongate body having a proximal end portion and a distal end portion. The filter assembly includes a guidewire tracking member, and a filter member coupled to the guidewire tracking member and that is adjustable between a radially collapsed configuration and a radially expanded configuration. The distal end portion of the delivery member is detachably coupled to the guidewire tracking member and is adapted to advance the filter assembly with the filter member in the radially collapsed configuration over the guidewire to the location by manipulating the proximal end portion of the delivery member externally of the patient's body. The filter member is adjustable at the location from the radially collapsed configuration to a radially expanded configuration that spans across a substantial cross-section of the lumen. The filter member in the radially expanded configuration at the location is adapted to filter components of fluid flowing through the lumen at the location above a predetermined size. The adjustable lock assembly is adapted to lock the filter assembly onto the distal end portion of the guidewire at the location, and the delivery member is detachable from the guidewire tracking member at the location. Another aspect of the present disclosure is an embolic filter system with a delivery assembly that cooperates with a filter assembly as follows. The filter assembly has a filter member having a wall with a substantially annular passageway around a circumference, and with a superelastic loop- shaped member coupled to the filter member within the annular passageway and along the circumference. The superelastic loop-shaped support member is adjustable between a radially collapsed condition corresponding with an elastically deformed condition for the loop-shaped member and a radially expanded condition according to material recovery from the elastically deformed condition to a memory condition. Adjusting the support member from the radially collapsed condition to the radially expanded condition adjusts the filter member between a radially collapsed configuration and a radially expanded configuration, respectively. The filter assembly is adapted to be delivered at least in part with the delivery assembly to a location within a lumen in a body of a patient with the support member radially confined in the radially collapsed condition and the filter member in the radially collapsed configuration. The support member and filter member are adjustable from the radially collapsed condition and radially collapsed configuration, respectively, to the radially expanded configuration and radially expanded configuration, also respectively, at the location. The filter member in the radially expanded configuration at the location spans across a substantial cross-section of the lumen. The filter member in the radially expanded configuration at the location is adapted to filter components of fluid flowing through the lumen at the location above a predetermined size. [0064] Another aspect of the present disclosure is an embolic filter system as follows. The system includes a delivery member with an elongate body having a proximal end portion and a distal end portion with a longitudinal axis, and a lumen extending between proximal and distal ports each being located along the distal end portion. The system also includes a filter assembly with a filter member coupled to a support member and that is adjustable from a radially collapsed configuration corresponding with an elastically deformed condition for the filter member and to a radially expanded configuration according to memory recovery from the elastically deformed condition toward a memory condition. The filter assembly in the radially collapsed configuration is radially confined within the lumen and is adapted to be delivered to a location within a lumen in a body of a patient. The filter assembly is adjustable from the radially collapsed configuration at the location to the radially expanded configuration at the location by removal of the filter assembly from the radially confining lumen. The filter member in the radially expanded configuration at the location spans across a substantial cross- section of the lumen, and is adapted to filter components of fluid flowing through the lumen at the location above a predetermined size. [0065] Another aspect of the present disclosure is a method for filtering emboli from fluid flowing across a location within a body lumen in a patient that includes the following steps. A filter assembly is delivered in a radially collapsed configuration over a guidewire to the location. The filter assembly is locked onto the guidewire at the location, and is then adjusted from the radially collapsed configuration to a radially expanded configuration at the location. The filter assembly in the radially expanded configuration at the location spans across a substantial cross-section of the body lumen and is adapted to filter the emboli from the fluid flowing across the location. [0066] Another aspect of the present disclosure is a method for filtering emboli from fluid flowing across a location within a body lumen in a patient as follows. A filter assembly is delivered with a delivery member in a radially collapsed configuration over a guidewire to the location. The filter assembly is detached from the delivery member at the location. The filter assembly is adjusted from the radially collapsed configuration to a radially expanded configuration at the location, which spans across a substantial cross-section of the body lumen and is adapted to filter the emboli from the fluid flowing across the location. The filter assembly is thereafter collapsed with filtered emboli captured therewith. Then, the collapsed filter assembly is removed from the body lumen. Another aspect of the present disclosure is another method for filtering emboli from fluid flowing across a location within a body lumen in a patient as follows. A filter assembly is positioned in a radially collapsed configuration within a capture lumen of a radially confining cuff having an adjustable position relative to the filter assembly. The filter assembly is provided in the radially collapsed configuration within the adjustable radially confining cuff along a distal end portion of a delivery member. The distal end portion of the delivery member and filter assembly are delivered in the radially collapsed condition within the cuff to the location, and the filter assembly is adjusted from the radially collapsed configuration to a radially expanded configuration at the location by adjusting the relative position of the cuff relative to the filter assembly such that the filter assembly is released from radial confinement and self-expands according to material memory to the radially expanded condition. The filter assembly in the radially expanded configuration at the location spans across a substantial cross-section of the body lumen and is adapted to filter the emboli from the fluid flowing across the location. The filter assembly is thereafter collapsed with filtered emboli captured therewith by positioning the filter assembly at least in part back within the radially confining cuff, and is removed at least partially confined within the cuff from the body lumen. Further to this method, the capture lumen extends along a length between proximal and distal ports and is located entirely within the body lumen, such as for example when the filter assembly is located within the cuff to the location.

[0068] Another aspect of the present disclosure is a method for assembling an embolic filter system as follows. A guidewire is provided that has a proximal end portion and a distal end portion with a first length that is adapted to be positioned at a location within a lumen in a patient while the proximal end portion extends externally from the patient. A filter assembly is also provided with a filter member coupled to a guidewire tracking member having a guidewire lumen extending with a second length between a proximal port and a distal port. The guidewire lumen is slideably engaged over the guidewire. The second length is less than the first length, such that the filter assembly is a shuttle that tracks over the guidewire. The shuttling filter assembly according to a further mode is locked onto the distal end portion of the guidewire. [0069] Another particular beneficial aspect of the present invention is a system for filtering emboli from fluid at a location within a lumen in a patient's body.

This system includes an adjustable, integral scaffold body and a filter member. The scaffold body includes an adjustable guidewire lock assembly integral with an adjustable filter support scaffold. The filter member is coupled to the adjustable filter support scaffold. The adjustable integral scaffold body in a first configuration is adapted to slideably engage and track over a guidewire to the location with the guidewire lock assembly in an open configuration, and with the adjustable filter support scaffold in a radially collapsed configuration such that the filter member spans a first diameter. At the filtering location, the adjustable integral scaffold body is adjustable to a second configuration with the guidewire lock assembly adjusted to a locked configuration that is adapted to substantially lock onto the guidewire, and with the adjustable filter support scaffold adjusted to a radially extended configuration such that the filter member spans a second diameter that is greater than the first diameter and that is adapted to engage a wall of the lumen at the location.

[0070] Another aspect is a system for filtering emboli from fluid at a location within a lumen in a patient's body, and that includes a filter member provided with the following particular modes. A means for delivering the filter member over a guidewire to the location is provided. A means is also provided for adjusting the filter member at the location between a radially collapsed configuration that spans a first diameter and a radially extended configuration that spans a second diameter. Also provided is a means for substantially securing the filter member relative to the guidewire in situ at the location. In addition, a means for supporting the filter member in the radially extended configuration at the location is also provided. The means for substantially securing the filter member to the guidewire and the means for supporting the filter member in the radially extended configuration at the location are integral.

[0071] According to one mode of this aspect, the means for substantially securing the filter member to the guidewire comprises an adjustable guidewire lock assembly that is adjustable between an open configuration that tracks over a guidewire and a locked configuration that locks onto a guidewire. In addition, the means for supporting the filter member comprises an adjustable filter support scaffold that is adjustable between a radially collapsed configuration that spans a first inner diameter and a radially extended configuration that spans a second diameter that is greater than the first diameter. The adjustable guidewire lock assembly and adjustable filter support scaffold together comprise one integral scaffold body. The scaffold body is adjustable between a first configuration, which corresponds with the open configuration for the lock assembly and the radially collapsed configuration for the filter support scaffold, and a second configuration, which corresponds with the locked configuration for the lock assembly and the radially extended configuration for the filter support scaffold.

[0072] According to the preceding aspects just described, further modes include the following. [0073] According to one mode, the integral scaffold body comprises an integral piece of material of unitary construction in a patterned shape across the adjustable guidewire lock assembly and adjustable filter support scaffold.

[0074] In one embodiment of this mode, the integral piece of material comprises one continuous wire filament in the patterned shape. In another embodiment, the integral piece of material comprises a shape memory material. According to one further feature, the scaffold body may be adjustable at the location from the first configuration to the second configuration by superelastic recovery force of the shape memory material from a superelastically deformed shape that characterizes the first configuration toward a memory shape. According to another feature, the scaffold body is adjustable at the location from the first configuration to the second configuration by heating the shape memory material above a transition temperature. [0075] In another mode, the integral piece of material comprises a substantially tubular wall along the lock assembly. The substantially tubular wall has a memory shape with a first inner diameter. In the open configuration the substantially tubular wall is retained open in a radially expanded condition with a second inner diameter under an applied force from the memory shape, wherein the second inner diameter is larger than the first inner diameter. The substantially tubular wall when released from the applied force self-collapses under a material recovery force toward the memory shape. [0076] According to one embodiment of the present mode, the substantially tubular wall in the locked configuration has a third inner diameter in confronting engagement with an outer surface of the guidewire and that is greater than the first inner diameter and less than the second inner diameter. In another embodiment, the substantially tubular wall comprises a voided pattern of nickel-titanium material around an interior passageway. In another embodiment, a delivery assembly comprises an adjustable lock retainer. The lock retainer is adjustable between a first condition wherein the adjustable guidewire lock assembly is retained in the open configuration under an applied force from the lock retainer and a second condition wherein the adjustable guidewire lock assembly is released from the adjustable lock retainer and self-collapses to the locked configuration under force of material recovery to the memory shape. In another embodiment, the integral piece of material comprises a patterned shape cut from a nickel-titanium tube. [0077] According to another mode, a delivery system is provided that comprises a filter support scaffold retainer. The filter support scaffold retainer is adjustable between first and second conditions relative to the adjustable filter support scaffold such that in the first condition the adjustable filter support scaffold is retained in the radially collapsed configuration, and in the second condition the filter support scaffold is released to self-expand to the radially extended configuration. [0078] According to another mode, a delivery assembly is provided that comprises a guidewire lock retainer and a filter support scaffold retainer. The guidewire lock retainer cooperates with the adjustable guidewire lock assembly and is adjustable between a first condition corresponding with the first configuration and wherein the adjustable guidewire lock assembly is retained in the open configuration under an applied force from the guidewire lock retainer, and a second condition corresponding with the second configuration and wherein the adjustable guidewire lock assembly is released from the adjustable guidewire lock retainer and self-collapses to the locked configuration under a force of material recovery to a first memory shape. The filter support scaffold retainer is adjustable between a first condition corresponding with the first configuration and wherein the adjustable filter support scaffold is retained in the radially collapsed configuration, and a second condition corresponding with the second configuration and wherein the filter support scaffold is released to self-expand to the radially extended configuration under a force of material recovery to a second memory shape. [0079] According to one embodiment of this mode, the guidewire lock assembly retainer comprises an inner tubular member, and the filter support scaffold retainer comprises an outer tubular member with a retention lumen extending along a length relative to a longitudinal axis. In the first configuration the inner tubular member is positioned at a first longitudinal position within the outer tubular member. In the second configuration the inner tubular member is withdrawn from the first longitudinal position to a second longitudinal position that is proximal from the first longitudinal position relative to the outer tubular member. [0080] Another aspect of the present invention is a method for manufacturing an embolic filter assembly for filtering emboli from fluid at a location within a lumen in a patient's body. This method includes forming a scaffold body that comprises an adjustable guidewire lock assembly and an adjustable filter support scaffold, wherein the scaffold body is formed from one integral piece of material in a patterned shape across the adjustable guidewire lock assembly and adjustable filter support scaffold. [0081] According to one mode, the method includes cutting the scaffold body into the patterned shape from a precursor material. [0082] In another mode, the scaffold body is cut from a tube of shape memory material into a first patterned memory shape. In one embodiment, this shape memory material comprises nickel-titanium. In another embodiment, the cut scaffold body is retrained from the first patterned memory shape to a second patterned memory shape that is different than the first patterned memory shape. [0083] According to one further feature of this embodiment, the method also includes providing the guidewire lock assembly with a substantially tubular member having a first inner diameter in the first patterned memory shape, and retraining the substantially tubular member of the guidewire lock assembly to the second patterned memory shape having a second inner diameter that is less than the first inner diameter.

[0084] Another feature includes providing the integral piece of material along the guidewire lock assembly with a substantially tubular structure having an inner guidewire passageway, and positioning an adjustable lock retainer at a first position within the inner guidewire passageway so as to radially expand and deform the substantially tubular structure to a superelastically deformed shape with a radially expanded inner diameter from a memory shape with a radially collapsed inner diameter that is less than the radially expanded inner diameter. The expanded inner diameter corresponds with an open configuration for the adjustable guidewire lock assembly that is configured to slideably engage and track over a guidewire. The lock retainer is adjustable from the first position to a second position that is removed from the inner . guidewire passageway so as to allow the substantially tubular member to self- collapse under a material recovery force radially inward from the deformed shape with the radially expanded inner diameter toward the memory shape with the smaller radially collapsed inner diameter.

[0085] In still a further feature to the foregoing, the method also includes positioning a guidewire within the inner guidewire passageway when the lock retainer is in the first position and the guidewire lock assembly is in the open configuration, and retaining the guidewire within the inner guidewire passageway while adjusting the lock retainer to the second position. The guidewire has an outer diameter that is greater than the radially collapsed inner diameter corresponding with the memory shape for the substantially tubular member of the guidewire lock assembly. The substantially tubular member of the guidewire lock assembly is allowed to confront and compress onto the guidewire under the material recovery force of recovery radially inward from the deformed shape and toward the memory shape. The guidewire lock assembly compressed onto the guidewire corresponds with a locked condition wherein the guidewire lock assembly is substantially locked onto the guidewire. In still further developments according to this feature, the lock retainer comprises a tubular member with a guidewire lumen. The guidewire is positioned within the guidewire lumen. [0086] Another mode of the present aspect includes positioning an outer retention sheath of an adjustable filter support scaffold retainer at a first position around the adjustable support scaffold so as to radially confine the adjustable filter support scaffold to a superelastically deformed shape in a radially collapsed configuration with a radially collapsed outer diameter from a memory shape with a radially extended outer diameter that is greater than the radially collapsed outer diameter. The radially collapsed configuration for the support scaffold corresponds with a first configuration for the scaffold body and with the guidewire lock assembly in an open configuration such that the scaffold body is configured to be delivered to a location within a lumen of a patient's body slideably over a guidewire. The method according to this mode also includes adjusting the filter support scaffold retainer from the first position to a second position that is removed from the adjustable filter support scaffold to thereby allow the adjustable filter support scaffold to self-expand to a radially extended configuration under a material recovery force radially outward from the deformed shape with the radially collapsed outer diameter toward the memory shape with the larger radially extended outer diameter. [0087] According to another mode associated with the feature preceding the previous mode, the method includes positioning an outer retention sheath of an adjustable filter support scaffold retainer at a first position around the adjustable support scaffold so as to radially confine the adjustable filter support scaffold to a superelastically deformed shape in a radially collapsed configuration with a radially collapsed outer diameter from a memory shape with a radially extended outer diameter that is greater than the radially collapsed outer diameter. The radially collapsed configuration for the support scaffold corresponds with a first configuration for the scaffold body and with the guidewire lock assembly in an open configuration such that the scaffold body is configured to be delivered to a location within a lumen of a patient's body slideably over a guidewire. The filter support scaffold retainer is adjusted from the first position to a second position that is removed from the adjustable filter support scaffold to thereby allow the adjustable filter support scaffold to self-expand to a radially extended configuration under a material recovery force radially outward from the deformed shape with the radially collapsed outer diameter toward the memory shape with the larger radially extended outer diameter. In addition, the tubular member of the lock retainer is positioned within the outer retention sheath. [0088] According to one further embodiment associated with this mode, the method also includes positioning each of the guidewire lock assembly retained by the guidewire lock retainer in the open condition, and the filter support scaffold retained by the outer retention sheath in the radially collapsed configuration, within the outer retention sheath. In still a further feature, the method includes positioning a guidewire within the guidewire lumen and extending distally from the outer retention sheath while the guidewire lock assembly is retained in the open condition by the lock retainer and the filter support scaffold is retained in the radially collapsed configuration within the outer retention sheath. In another further embodiment, the method includes providing a stop within the outer retention sheath such that upon proximal withdrawal of the tubular member of the lock retainer relative to the outer retention sheath the guidewire lock assembly confronts the stop and is prevented from withdrawing with the tubular member, such that the tubular member may be withdrawn from the inner guidewire passageway of the lock assembly.

[0089] According to another mode of the present aspect, the method includes coupling a radiopaque material to the integral piece of material along at least one of the lock assembly and the filter support scaffold.

[0090] In another mode, the method includes coupling the filter support scaffold to a filter member that is configured to filter emboli from fluid flowing through the filter member when the filter member is supported by the filter support scaffold at a location across a lumen in a patient's body. [0091] Another aspect of the present invention is a system for filtering emboli from fluid at a location within a lumen in a patient's body, and includes an adjustable embolic filter module comprising a guidewire lock assembly and an embolic filter assembly. The adjustable embolic filter module in a first configuration is adapted to slideably engage and track over a guidewire to the location with the guidewire lock assembly in an open configuration and with the embolic filter assembly in a radially collapsed configuration with a first diameter. The adjustable embolic filter module is adjustable at the location to a second configuration with the guidewire lock assembly in a locked configuration that is adapted to substantially lock onto the guidewire, and with the embolic filter assembly in a radially extended configuration that spans a second diameter that is greater than the first diameter and that is adapted to engage a wall of the lumen at the location. In the second configuration at the location, the adjustable embolic filter module is further adapted to allow limited relative motion between the guidewire lock assembly in the locked configuration and the embolic filter assembly in the radially extended configuration in response to an applied force to at least one of the guidewire lock assembly and the embolic filter assembly. [0092] Another aspect of the present invention is a system for filtering emboli from fluid at a location within a lumen in a patient's body, and also includes an adjustable embolic filter module comprising a guidewire lock assembly and an embolic filter assembly. The adjustable embolic filter module in a first configuration is adapted to slideably engage and track over a guidewire to the location with the guidewire lock assembly in an open configuration and with the embolic filter assembly in a radially collapsed configuration with a first diameter. The adjustable embolic filter module is adjustable at the location to a second configuration with the guidewire lock assembly in a locked configuration that is adapted to substantially lock onto the guidewire, and with the embolic filter assembly in a radially extended configuration that spans a second diameter that is greater than the first diameter and that is adapted to engage a wall of the lumen at the location. Also provided is means for allowing limited relative motion between the guidewire lock assembly in the locked configuration and the embolic filter assembly in the radially extended configuration in response to an applied force to at least one of the guidewire lock assembly and the embolic filter assembly in the second configuration at the location. [0093] One mode of the preceding aspects includes a dynamic motion coupler extending between the guidewire lock assembly and the embolic filter assembly. [0094] In one embodiment of this mode, the dynamic motion coupler comprises a spring extending between the guidewire lock assembly and the embolic filter assembly. In another embodiment, the dynamic motion coupler comprises a tether extending between the guidewire lock assembly and the embolic filter assembly. [0095] According to another mode, the filter assembly comprises a filter support scaffold. The guidewire lock assembly, the filter support scaffold, and the dynamic motion coupler are integral and comprise a single unitary piece of material in a patterned shape. In one further embodiment of this mode, a filter member is coupled to the filter support scaffold. In another embodiment, the piece of material comprises a cut tube of shape memory material. [0096] Another aspect of the present invention is a method for filtering emboli from fluid at a location within a lumen in a patient's body. This method includes providing an adjustable embolic filter module comprising a guidewire lock assembly and an embolic filter assembly; advancing a guidewire to the location; slideably engaging the adjustable embolic filter module in a first configuration over a guidewire; tracking the adjustable embolic filter module in the first configuration over the guidewire to the location; adjusting the embolic filter module from the first configuration to a second configuration by locking the guidewire lock assembly onto the guidewire so as to substantially secure the adjustable embolic filter module to the guidewire at the location, and by radially extending the embolic filter assembly to engage a blood vessel wall at the location; and, with the embolic filter module in the second configuration at the location, applying a force to at least one of the guidewire lock assembly and the embolic filter assembly. In addition, limited relative motion is allowed between the guidewire lock assembly locked onto the guidewire and the radially extended embolic filter assembly engaged to the lumen wall in response to the applied force. [0097] According to one mode of this aspect, the limited relative motion is provided by a dynamic motion coupler extending between the guidewire lock assembly and the filter assembly. According to one embodiment, the dynamic motion coupler comprises a tether between the guidewire lock assembly and the filter assembly. According to another embodiment, the dynamic motion coupler comprises a spring. [0098] According to another mode, the applied force is transmitted by the motion of the guidewire.

[0099] In one embodiment of this mode, this involves moving the guidewire longitudinally in the lumen at the location. The applied force comprises a longitudinal applied force, and the limited relative motion comprises longitudinal relative motion. In one further feature, the longitudinal relative motion comprises collapsing a relative distance relative to the lock assembly and filter assembly. In another further feature, the longitudinal relative motion comprises extending a distance relative to the lock assembly and the filter assembly.

[00100] According to another embodiment, moving the guidewire comprises rotating the guidewire, the applied force comprises a rotational force, and the limited relative motion comprises rotational relative motion. [00101] Another aspect of the present invention is a system for treating a tight occlusion in a patient's blood vessel and filtering emboli from blood distal to the occlusion in a patient's body. This system includes a vascular occlusion crossing system with a guidewire having a proximal end portion, a distal end portion, and an intermediate portion between the proximal and distal end portions, and also with at least one of an actuator or a sensor cooperating with the guidewire's distal end portion. An adjustable embolic filter assembly is also included, as is a delivery assembly coupled to the adjustable embolic filter assembly. The vascular occlusion crossing system is adapted to advance the distal end portion of the guidewire across a blockage and to the filter location within the blood vessel at least in part by aid of the actuator or sensor. The delivery assembly is adapted to deliver the embolic filter assembly to a position along the distal end portion of the guidewire at the location. The adjustable embolic filter assembly at the location is adapted to lock onto the guidewire and to be released from the delivery assembly in a configuration adapted to filter the emboli from the blood at the location. The adjustable embolic filter assembly and guidewire are adapted to be removed from the blood vessel together through a capture sheath. [00102] Another aspect of the present invention is a method for treating a patient suffering from a tight occlusion within a blood vessel in the patient's body while providing distal protection against blood emboli. This method includes providing a vascular occlusion crossing system with a guidewire and at least one of an actuator or a sensor cooperating with the guidewire; providing an adjustable embolic filter module; advancing the vascular occlusion crossing system across a tight occlusion in the blood vessel and to the location at least in part by aid of the actuator or sensor; slideably engaging the adjustable embolic filter module over the guidewire advanced to the location; tracking the adjustable embolic filter module over the guidewire to the location; locking the adjustable embolic filter module onto the guidewire at the location; filtering the emboli from the blood with the adjustable embolic filter module locked onto the guidewire; and removing the guidewire and adjustable embolic filter module locked onto the guidewire from the blood vessel through a capture sheath.

[00103] Another aspect of the present invention is a system for filtering emboli from fluid at a location within a lumen in a patient's body as follows. A guidewire is provided with a proximal end portion and a distal end portion, and at least one of an actuator and a sensor is coupled to the guidewire. An adjustable embolic filter assembly is also provide in the system. A delivery assembly is coupled to the adjustable embolic filter assembly. The distal end portion of the guidewire is configured to be positioned across the location with the proximal end portion extending externally from the patient; The delivery assembly is configured to deliver the embolic filter assembly over the guidewire and to a position along the distal end portion of the guidewire at the location. The embolic filter assembly is releasable from the delivery assembly at the position at the location such that the delivery assembly is removable from the patient independent of the embolic filter assembly. The embolic filter assembly when released from the delivery assembly at the position cooperates with the guidewire in a manner such that the embolic filter assembly is removable from the location by proximal withdrawal of the guidewire from the location into a capture sheath.

[00104] Another aspect of the present invention is a method for filtering emboli from fluid at a location in a lumen within a patient. This method aspect includes: providing a guidewire; coupling at least one of an actuator or a sensor with the guidewire; providing an adjustable embolic filter module; advancing the vascular occlusion crossing system across a tight occlusion in the blood vessel and to the location at least in part by aid of the actuator or sensor; slideably engaging the adjustable embolic filter module over the guidewire advanced to the location; tracking the adjustable embolic filter module over the guidewire to the location; locking the adjustable embolic filter module onto the guidewire at the location; filtering the emboli from the blood with the adjustable embolic filter module locked onto the guidewire; and removing the guidewire and adjustable embolic filter module locked onto the guidewire from the blood vessel through a capture sheath. [00105] Another aspect of the present invention is a system for filtering emboli from fluid at a location within a lumen in a patient's body. This system includes a guidewire with a proximal end portion and a distal end portion with an enlarged distal tip, and an embolic filter module with a guidewire lock assembly and a filter assembly that is adapted to be delivered over the guidewire to a position proximal of the tip and to be locked onto the guidewire at the position via the guidewire lock assembly.

[00106] Another aspect of the present invention is a system for filtering emboli from fluid at a location within a lumen in a patient's body, and that includes a guidewire with a proximal end portion and a distal end portion with a distal tip, a delivery assembly, and an embolic filter module that is deliverable with the delivery assembly over the guidewire to a position along the guidewire proximal of the enlarged distal tip and to be released from the delivery assembly at the position in coupled relationship with the guidewire. At least one of an actuator or a sensor is coupled to the guidewire. The at least one of an actuator or sensor is configured to actuate or sense at least one property associated with the guidewire and other than in relation to the coupling relationship between the guidewire and the filter module.

[00107] Various additional modes are contemplated in relation to the preceding aspects providing certain types of guidewires in combination with filter assemblies as follows. [00108] In one mode, an actuator is mechanically coupled to the guidewire for actuated motion of the guidewire. [00109] In one embodiment, the actuator comprises a mechanical rotation assembly that mechanically spins the guidewire.

[00110] In another embodiment, the actuator comprises a mechanical translational assembly that moves the guidewire along a longitudinal axis.

[00111] In another embodiment, the actuator comprises a vibrational source that vibrates the guidewire. [00112] According to another mode, an actuator is electrically coupled to the guidewire. [00113] According to another mode, an actuator is configured to adjust the shape of the guidewiire in-situ. [00114] According to another mode, a sensor is coupled to the guidewire in a manner configured to visualize or sense a property of at least one tissue structure within a region adjacent to the guidewire when the guidewire is positioned within the lumen.

[00115] Another aspect of the present invention is an adjustable embolic filter system. This system includes a tubular body with a tubular wall that defines an inner guidewire lumen, and a filter assembly coupled to the tubular wall and adjustable between a radially collapsed configuration and a radially extended configuration. An imbedded lumen is located within the tubular wall and with a port through which the imbedded lumen communicates internally into the inner guidewire lumen.

[00116] According to one mode of this aspect, an injectable material delivery system is coupled to the imbedded lumen and configured to inject an injectable material into the inner guidewire lumen through the port. [00117] In one embodiment, an injectable material is configured to be injected by the delivery system into the imbedded lumen and through the port into the guidewire lumen. The injected adhesive material is configured relative to the guidewire lumen and a guidewire dwelling therein so as to secure the tubular body to the guidewire.

[00118] In another embodiment, an injection needle is provided with a proximal end portion configured to be coupled to a source of injectable material and a distal end portion having a threaded portion. The imbedded lumen comprises a second threaded portion. The injection needle is configured to be releasably coupled to the imbedded lumen via threaded engagement between the first and second threaded portions. According to one further feature, the needle comprises at least two lumens extending from a proximal coupler along the proximal end portion and into the distal end portion. In another further feature, the needle comprises a mixing chamber along the distal end portion in which the at least two lumens communicate. In still another further feature, an injectable multi-part adhesive material is provided comprising first and second component precursor materials that polymerize or cure upon mixing. [00119] According to another mode, a delivery assembly is provided that comprises a delivery member that comprises an elongated tubular body with a delivery lumen. The delivery member is configured to couple the injection needle to the imbedded lumen via the delivery lumen. In one embodiment, the delivery assembly further comprises an outer cuff member with a tubular wall that defines an interior capture lumen, and the filter assembly is configured to be positioned within the interior capture lumen in the radially collapsed configuration and is releasable from the interior capture lumen to self-expand to the radially extended configuration via a material recovery force toward a memory shape. [00120] 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. [00121] 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) [00122] 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.

[00123] FIGS. 1A-D show plan schematic views of 4 sequential modes, respectively, of a system and method for attaching an embolic filter onto a guidewire before placing the attached assembly into the body of a patient. [00124] FIGS. 2A-B show side views of the distal end portion of one particular assembly wherein a distal embolic filter module is engaged over a guidewire in radially expanded and collapsed conditions, respectively. [00125] FIGS. 3A-B show side views of the distal end portion of another particular assembly wherein a distal embolic filter module is engaged over a guidewire in radially expanded and collapsed conditions, respectively. [00126] FIGS. 4A-B longitudinally cross-sectioned side views of another embolic filter assembly with a tubular support member coaxially engaged over a guidewire in a radially expanded unlocked condition and radially collapsed locked condition, respectively, with respect to the guidewire. [00127] FIGS. 5A-B show longitudinally cross-sectioned side views of another embolic filter embodiment in radially expanded unlocked and radially collapsed locked conditions, respectively, with respect to a coaxially engaged guidewire shown schematically extending therethrough.

[00128] FIGS. 6A-B longitudinally cross-sectioned side views of another embolic filter embodiment in radially expanded unlocked and radially collapsed locked conditions, respectively, with respect to a coaxially engaged guidewire shown schematically extending therethrough. [00129] FIG. 7 shows a longitudinally cross-sectioned side view of an embolic filtering assembly with an embolic filter device coaxially engaged over a guidewire with an expandable member on the guidewire adjustable between radially collapsed and expanded (shown in shadow) conditions corresponding to locked and unlocked configurations, respectively, between the filter and guidewire.

[00130] FIG. 8 shows a longitudinally cross-sectioned side view of a portion of a guidewire chassis that is adapted for use with an assembly such as that shown in FIG. 7.

[00131] FIG. 9A-C show longitudinally cross-sectioned side views of another embolic filter embodiment in various respective modes of use during a locking procedure over a guidewire. [00132] FIG. 10A shows a partial perspective view of a distal end portion of another embolic filter system in one mode of use for delivery to a filtering location in a body of a patient. [00133] FIG. 10B shows an exploded perspective view of a distal end portion of a similar filter to that shown in FIG. 10A, and shows in shadow the adjustability of the filter between radially collapsed and expanded conditions, respectively.

[00134] FIG. 10C shows an exploded perspective view of a distal end portion of a filter system similar to that shown in FIGS. 10A-B, and shows the outer sheath adjusted to a proximal position such that the filter is adjusted to the radially expanded condition that is adapted to filter emboli from blood in-vivo.

[00135] FIG. 10D shows an exploded perspective view of the same distal end portion of the filter system shown in FIG. 10C, except during another mode of use with the filter adjusted back to a radially collapsed condition that captures emboli for removal from the patient's body. [00136] FIGS. 11A-C show partially longitudinally cross-sectioned side view of another embolic filter system that is adapted to provide in-vivo placement and locking engagement of a filter over an "indwelling" guidewire during various respective modes of use including slideable placement over the guidewire shown in FIG. 11 A, locking engagement and detachment shown in FIG. 11 B, and radial adjustment to a radially expanded condition for filtering blood shown in FIG. 11 C. [00137] FIG. 12 shows a longitudinally cross-sectioned side view of another modified embodiment of the filter system shown in FIGS. 1 1A-C. [00138] FIG. 13A shows a side view of a tube in a first condition corresponding with a first mode of manufacturing an integral lockable scaffold for use in supporting and delivering a filter assembly onto a guidewire in situ. [00139] FIG. 13B shows a side view of the tube shown in FIG. 13A in a second condition corresponding with a second mode of manufacturing the integral lockable scaffold wherein the tube is cut into a patterned scaffold assembly. [00140] FIG. 13C shows a side view of an embolic filter assembly that includes the patterned scaffold assembly shown in FIG. 13B 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 lockable scaffold. [00141] FIG. 14 shows a longitudinally cross-sectioned side view of another adjustable filter module within a particularly beneficial delivery assembly over a guidewire.

[00142] FIGS. 15A-C show respective pictures taken of another adjustable filter module that was manufactured, and shows the module during various respective modes of use over a guidewire.

[00143] FIGS. 16A-C show respective pictures taken of the adjustable filter module shown in FIGS. 15A-C during still further modes of use with a guidewire.

[00144] FIGS. 17A-C show side views of another embolic filter assembly 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 with a dynamic coupler between the lock assembly and the filter assembly.

[00145] FIGS. 18A-G show various schematic side views of another adjustable embolic filter assembly during sequential modes of use in an overall system and method for treating chronic total occlusion with distal protection. [00146] FIGS. 19A-B show respective partially longitudinally cross-sectioned side views of respective component aspects of another adjustable embolic filter assembly.

DETAILED DESCRIPTION OF THE INVENTION

[00147] Referring more specifically to the drawings, the Figures 1-19B 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.

[00148] 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. [00149] According to other aspects illustrated by various of the embodiments below, 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 correspond 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. [00150] Accordingly, further more detailed embodiments are provided as follows and provide further illustration of the various aspects provided above, as well as other beneficial aspects as is made apparent to one of ordinary skill with this disclosure. [00151] FIGS 1A-D show various modes of operation according to one embodiment that provides an embolic filter assembly 10 as follows. [00152] FIG. 1A shows a filter module 12 that is coupled to an actuator assembly 30 and is provided separate from a guidewire 40. Filter module 12 includes a tubular support spine 14 with an inner lumen 16, onto which is coupled an adjustable filter member 20. Actuator assembly 30 includes an actuator 32 and a coupling member 36 that couples actuator 32 to filter module 12. [00153] FIG. 1 B shows filter module 12 slideably engaged over distal end portion 42 of guidewire 40 via inner lumen 16 in a "backloading" technique initiated at guidewire tip 44, typically provided as a pre-shaped or shapeable, steering tip. At the desired position along guidewire distal end portion 42, the filter module 12 is actuated via actuator 32 and coupling member 36 to lock onto the guidewire. Once filter module 12 is locked onto guidewire 40, coupling member 36 is detached from filter module 12 and thus filter module

12 and guidewire 40 become an integrated assembly, as shown in FIG. 1C. As further shown in FIG. 1C, this is performed while guidewire 40 is slideably engaged within delivery lumen 56 of delivery sheath 50, and while guidewire distal end portion 42 extends distally from distal tip 54 of the distal end portion 52 of that delivery sheath. However, the assembly of filter module 12 and guidewire 40 may be performed in other manners of operation, such as prior to engaging the guidewire 40 within delivery lumen 56.

[00154] As shown in FIG. 1D, once the filter module 12 and guidewire 40 are locked together and coupled, the filter module 12 is adjusted relative to the longitudinal axis L of delivery sheath 50 so as to be positioned within delivery lumen 56, thus collapsing adjustable filter member 20 from a radially expanded condition shown in FIG. 1A-1C to a radially confined condition shown in FIG. 1 D. FIG. 1 D shows certain further detail of one embodiment for filter member 20 for further illustration, and shows a collapsed configuration for a proximal support member 24 and folded filter wall 22. Proximal support member is for example a ring-shaped support member that is constructed of a superelastic alloy material, such as a nickel-titanium material, having a memory shape corresponding the a radially expanded configuration that further corresponds to the expanded condition of the filter member 20 shown in FIGS. 1A-C. Filter wall 22 is for example a porous sheet of materia_,!, or other filter membrane or structure. Further aspects of these respective components will be explained in further detail by reference to other exemplary embodiments below.

[00155] It is to be appreciated therefore that the embodiment illustrated by FIGS. 1A-D 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 44. This allows the ability to customize the filtering location in reference to a desired placement of the guidewire tip 44 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. [00156] FIGS. 2A-B show further detail of a filter module 60 according to one more particular embodiment as follows, and is shown after being locked and detached onto guidewire 40, and before (FIG. 2A) and after (FIG. 2B) being radially confined within a delivery lumen 56 of a delivery sheath 50.

[00157] More specifically, FIG. 2A shows filter member 61 in a radially expanded condition externally of sheath 50. A distally tapering circumferential wall 63 extends between an open proximal end 62, where it is supported by a ring or "loop"-shaped support member 64, and a distal end 66, where it is secured onto tubular support spine 70 that is locked onto wire 40 within inner lumen 72. In the radially expanded configuration shown in FIG. 2A distally extended from delivery sheath 50, the filter member 61 thus provides a pocket 65 that is open along proximal end 62, and closed at distal end 66. Wall 63 is substantially porous to such that normal physiologic blood components flowing into the pocket 65 will pass through wall 63, but whereas debris above a predetermined dimension, such as from upstream (e.g. proximal relative to the module 60) interventions, will not pass and be captured within pocket 65.

[00158] FIG. 2B shows engagement of the module 60 within delivery lumen 56 of delivery sheath 50 subsequent to forming a filtering operation and with certain debris captured within filter member 61. As shown in one particular illustrative mode, such debris may provide increased profile to the collapsed condition of filter module 60, and thus it may be only partially engageable within the radially confining lumen 56 of sheath 50. However, in such circumstance, such may be removed as a system from the body, with the debris successfully filtered, captured, and removed. [00159] FIG. 2B further shows more detail of the relationship between proximal support member 64 and its radially collapsed condition in the radially collapsed configuration for module 60 within delivery lumen 56 of sheath 50. Sheath 50 essentially grooms ring or "loop"-shaped support member 64 into a relatively linear orientation along longitudinal axis L, and radially collapses the otherwise open ring to a radially collapsed condition. This orientation allows for sufficient real estate within delivery lumen 56 to house support member 64 in the collapsed condition. Support member 64 may be provided in a slightly canted orientation in the radially expanded condition outside of sheath 50 in order to accommodate smooth relative advancement of sheath 50 over the ring-shape during the grooming process of radial engagement within lumen 56.

[00160] Support member 64 may be coupled to the annular end of the material sheet forming filter member 61 in a variety of modes apparent to one of ordinary skill, though the particular beneficial mode shown herein is described as follows for illustration (not shown). The annular end 62 includes a circumferential pouch formed by inverting or everting the end of the material sheet forming filter member 61 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 64 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. [00161] This all may be accomplished for example by forming the member initially as a flat sheet and providing support member 64 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 70. 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 spine 70 to form the filter module 60. In this arrangement, of course 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 66 which is rendered in a closed condition and secured to guidewire tracking and support spine 70. [00162] The radially collapsed condition for support member 64 corresponds to a radially collapsed configuration for the overall filter assembly or module 60, which further includes a folded orientation for filter member 61. The radially expanded condition for support member 64 corresponds to a radially expanded configuration for filter assembly module 60, which includes an orientation for filter member 61 that spans across a substantial cross-section of the respective lumen within which it is deployed. In the particular beneficial embodiments shown, support member 64 is a material having substantial shape member, such as a metal alloy such as nickel-titanium alloy that demonstrates either shape member under thermal changes, or superelastic shape memory, during the change of conditions for the component. For example, the radially collapsed condition corresponds with a deformed condition of the material from a memory condition. The support member 64 is kept in the deformed condition within radially confining lumen 56 of sheath 50. Upon distal advancement therefrom, the force of radial confinement is removed, and thus support member 64 self-adjusts to the radially expanded or extended condition according to material recovery to the memory condition. Such memory condition and related memory shape may correspond with the shape shown for the radially expanded condition, or the memory shape may be something different and the support member 64 is still under some constraint or deformation therefrom even in the radially expanded condition.

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 support member 64 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.

[00163] The particular shape and arrangement of filter member 61 in FIGS. 2A- B is illustrative and various other embodiments or variations are contemplated. [00164] For example, FIGS. 3A-B show a particular arrangement that is modified from the embodiment of FIGS. 2A-B as follows. Filter module 80 is shown after being already locked and detached onto a guidewire 40, and includes a filter member 81 secured to a tubular support spine 90 that is locked onto guidewire 40 via inner lumen 92. Filter member 81 includes a circumferential filter wall 81 that extends between a proximal end 82 where it is coupled to a ring-shaped proximal support member 84, and a distal end 86 where it is coupled to a second ring-shaped distal support member 88. A further filter wall 87 is provided that spans across the circumferential confines of distal support member 88 at distal end 86. According to this arrangement, in the radially extended or expanded conditions for proximal and distal support members 84,88 correspond with the radially expanded configuration for filter member 81. In this condition, filter wall 83 is adapted to extend along a blood vessel wall, whereas filter wall 87 spans substantially across the vessel. Accordingly, pocket 85 is formed that ends distally at filter wall 87 as a "catch" or backstop against which debris of sufficient size is caught and prevented from passing.

[00165] These various support rings may be provided in a similar manner previously described above by reference to FIGS. 1-2B. Moreover, the relation and modes of operation between respective radially collapsed and expanded conditions may also be achieved and demonstrated in a similar manner, as shown by relative comparison between FIGS. 3A-B. [00166] It is to be appreciated that, while the dual-support member embodiment just described is 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, as they are shown of equal size in FIG. 3A, they may nevertheless be of different sizes or shapes, such as for example providing the distal support 88 with a smaller circumference than proximal support 84, thus accommodating distally tapered lumens as described.

[00167] 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. [00168] One particular example is illustrated in FIG. 4A as follows. System 100 is shown to include a filter assembly or module 110 with a filter member 111 engaged to a guidewire tracking member as a support spine 120 for filter member 111. Support spine 120 tracks over a guidewire via guidewire lumen 125 extending between opposite guidewire ports at proximal and distal ends 122, 126. Support spine 120 is constructed as a composite tubular member, with a coiled or braided filament support 123 imbedded or laminated within or onto a polymer or other material matrix 121. Filter member 111 is shown in a radially expanded configuration with a distaily reducing tapered funnel-shaped wall 113 extending between a larger diameter open end 112 and a closed distal end 116 that is secured onto support spine 120 at distal end 126. [00169] An adjustable lock assembly 130 includes an electrical source 132 coupled to the filament support wire 123 at a coupling joint 138 at proximal end 122. In the present embodiment, wire 123 is constructed of a shape memory metal alloy that is exposed within lumen 125, and/or at one or both of ends 122,126, and is an electrical conductor. Electrical source 132 is also coupled to a second electrical lead 133 that is adapted to be coupled to the body. In this arrangement, a bipolar electrode system is created such that by actuating current source 132, current flows through a conductive path placed between wire filament 123 and electrode 133. Such may occur, for example, in an electrolytic bath, or in particular beneficial examples, using the patient as the conductor with the lead electrode 133 being for example a patch electrode positioned along the patient's back or other surface, and the wire filament 123 positioned with the module 1 10 along the guidewire 40 within the body at a desired filtering location. By allowing such current to flow, wire filament 123 is heated, and thus exhibits shape memory characteristics, which in this configuration is to recover to a memory shape having a smaller inner diameter id (FIG. 4B) than the inner diameter ID shown in the radially expanded condition in FIG. 4A. [00170] The resulting locked condition for the adjustable lock assembly is shown in FIG. 4B, which shows member 120 with a reduced inner diameter id corresponding with the radially collapsed condition and that is shrunk with radial force onto the guidewire 40 to lock the components together. It is to be appreciated that, in order to achieve this reconfiguration in heat shrink mode, the remaining features of the composite forming tubular member 120, more specifically matrix 121 in which wire filament 123 is imbedded, must recover with the material recovery of the filament 123. Accordingly such matrix may be for example an elastomer which, for example, is itself in a deformed condition in the radially expanded configuration for member 120 shown in FIG. 4A. As such, the material recovery of filament 123 to the collapsed condition shown in FlG. 2B also corresponds to a material recovery for the matrix 121. In this particular arrangement, filament 123 in the radially expanded condition shown in FIG. 4A will generally have such radial strength in that condition so as to hold the mating matrix 121 in the elastically deformed state until the composite is adjusted to the radially collapsed configuration shown in FIG. 4B.

[00171] As also shown in FIG. 4B, the electrical conductor that coupled wire filament 123 and electrical source 132 is thereafter detached from member 120, as it is no longer required or desired in order to allow wire 40 and module 110 to now operate as a unitary assembly. Such detachment may be achieved for example using electrolytic detachment, such as by providing an electrolytic joint at joint 138. Electrolytic joints and related electrolytic detachment mechanisms may be deployed in modes similar to those previously described, such as for example for use in Guglielmi Detachable Coils ("GDC") for delivering and detaching embolic coils for treating neuro- aneurysms. These prior disclosures may be suitably applied to this novel application, or may be suitably modified by one of ordinary skill based upon review of this disclosure and to the extent consistent with the desired objectives and results as herein described or otherwise readily apparent from the present description and embodiments shown. [00172] Moreover, it is also to be appreciated that multiple conductor leads 136 may be used, which are actuated together to heat filament 123, but which are individually coupled to filament 123 with individual sacrificial electrolytic joints. Following the combined actuation of the leads and related heat shrink operation to lock member 120 onto wire 40, each individual lead may be thereafter energized with higher current that crosses the threshold at which the sacrificial joint electrolytically dissolves, thus detaching the array from the filament 123. This allows lower individual currents along each conductor lead to combine for an overall current sufficient to heat shrink the wound or braided filament conductor 123, which may be below the electrolytic threshold for any one sacrificial joint, and then higher current at each joint above that threshold for dissolving the respective joint. [00173] Other adjustable lock mechanisms are contemplated. [00174] For example, FIGS. 5A-B show two respective modes of operation of a filter assembly 150 with a guidewire tracking support spine 160 with an adjustable lock mechanism shown adjusted between a radially expanded configuration with an inner diameter ID that is greater than the outer diameter OD of guidewire 40 as shown in FIG. 5A₁ and radially collapsed configuration with a reduced inner diameter id that is sufficient to engage outer diameter OD of guidewire 40, as shown in FIG. 5B. [00175] More specifically, discrete adjustable diameter cuffs 164,168 are located on opposite ends 162,166 of the guidewire tracking support spine 160. Distal cuff 168 is located distally to the distal attachment point of filter member 151 onto support spine 160. In this arrangement, tubular wall 161 of support spine 160 is contracted by the distal cuff 168, but is not required to contract where filter member 151 is secured to the tubular wall 161. Accordingly, tubular wall 161 is only required to provide the flexibility necessary for variable diameter sizing between the radially collapsed and expanded configurations at isolated regions. Where filter member 151 may be of such material construction not well adapted to be "shrunk" to a smaller diameter size, e.g. a preformed diameter that is non-elastomeric. Thus, it is further contemplated that tubular member 161 may have one construction along a mid-portion, and another more elastomerically adjustable construction at the locations where cuffs 164,168 are located, e.g. at the ends. In any event, these areas of tubular member 161 corresponding with cuffs 164,168 may be for example held elastomerically expanded by the coupling with expanded cuffs 164,168, for example via adhesive bonding or other mode of fixed engagement. Thus such regions may recover elastomerically to the radially collapsed configuration under the radial recovery force of cuffs 164,168 to the radially collapsed condition with an inner diameter id that matches outer diameter OD of guidewire 40. [00176] Cuffs 164,168 may be constructed of shape memory material, such as nickel-titanium or other shape memory alloy, and may be adjustable upon change of temperature such as by applied external energy, or locally delivered energy such as via electrical current flow through the devices for resistance heating, or electrical coupling to the cuffs as electrically conductive monopolar electrodes for a completed circuit that includes the patient as described above, or light energy such as via optical fiber coupling or local light emitters cooperating with the assembly, or ultrasound crystals or other transducers located to heat the cuffs. Or, they may have transition temperatures below body temperature but above their storage temperature, e.g. room temperature (or they may be kept cold). Is such circumstance, by raising temperature above a critical transition temperature, they recover or "shrink" to the memory shape that is radially collapsed condition shown in FIG. 5B. Moreover, the cuffs may be elastomeric, e.g. superelastic, and held superelastically stretched in the open configuration by a mechanism such as an internally adjustable sheath that, upon removal from the inner diameter ID allows material recovery to the memory condition that shrinks the cuffs onto the guidewire. The cuffs may be solid, or have other shapes such as similar to various different types of stent designs previously disclosed for adjustable diameter use, e.g. with an interconnected pattern of struts and intervening voids, such as cut from a tube using a laser or etching, etc. ] Other cuff-type embodiments are contemplated, as illustrated by way of example in FIGS. 6A-B. Here, a filter assembly module 180 is shown with a filter member 181 in partial cross-section view coupled to a tubular support spine 190 that has a tubular wall 191 providing a guidewire tracking member with a guidewire lumen 195 adapted in the radially expanded configuration shown to track over a guidewire 40. Proximal and distal cuffs 194,198 are located on each of two ends 192,196, respectively, of support spine 190 and within lumen 195 of tubular wall 191 , versus on an exterior thereof as in the previous embodiment of FIGS. 5A-B. This configuration may be highly beneficial in the circumstance where tubular wall 191 at the ends coupled to cuffs 194,198 is to be held elastomerically radially expanded in the radially expanded condition for cuffs 194,198 as shown in FIG. 6A. By adjusting the cuffs to their respective radially collapsed condition shown in FIG. 6B, the outer tubular member 191 surrounding the cuffs is allowed to elastically recover with those cuffs. [00178] It is to be appreciated that the various discrete cuff-type embodiments just described, though considered highly beneficial, are illustrative an other configurations, shapes, sizes locations, numbers, or respective arrangements of cuffs are contemplated. For example, as the cuffs are for selectively locking the overall filter assembly associated therewith onto the guidewire, a single cuff may suffice in certain arrangements. Such would simplify and reduce the cost of the overall arrangement, for example requiring only one actuator or coupler to deliver energy percutaneously to the cuff. [00179] The provision of a selective lock assembly that provides for selective locking between a guidewire tracking filter assembly and the respectively tracked guidewire is to be considered broadly. Many different selective locks may be used. In fact, such may not be required to be integrated with the filter assembly itself, but 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. [00180] Nevertheless, the following embodiment provides further detail of a system 200 that provides an adjustable lock mechanism on a specialized guidewire 240 constructed according to the description below and as shown variously in FIGS. 7 and 8.

[00181] FIG. 7 shows system 200 to include a filter module 210 with a filter member 214 secured to a tubular support spine 212 that slideably engages guidewire 240 as a guidewire tracking member. Guidewire 240 has a shaped distal tip 244 extending from a body 242 constructed from an internal tubular member 246 within an external coil 248 and with a port or aperture 247 therethrough into an internal space confined by a pressure expandable outer cuff 250 that is secured to the outer coil 248 on either end of aperture 247. By coupling an external source of pressurizeable fluid 256 to the passageway within tubular member 246, outer cuff 250 expands under pressure via aperture 247 to radially expand, as shown at expanded cuff 251 in shadow, to sufficient dimension to radially engage the internal surface of tubular support spine 212 and thereby lock the guidewire 240 with filter assembly 210 in a friction fit under the normal force of the expanded cuff 250. [00182] Various modes of construction may provide such a lock on a suitable guidewire to achieve the objective of locking into the interior of the guidewire tracking member of the filter assembly. Further detail of one construction of the core member suitable for use according to the embodiment shown in FIG. 7 is shown in FIG. 8. Tubular member 246 provides the proximal underlying guidewire chassis, and is constructed for example as a metal hypotube, e.g. stainless steel, nickel-titanium, etc., or from other suitable material to provide sufficient rigidity for torqueability and pushability requirements as generally understood for guidewires (e.g. may be high density polyethylene, or polyimide, or composite for example). Tubular member 246 is secured to a distal core member 243 by tapering the proximal end 245 of core member 243 to fit within the distal end hole or port 241 of the tubular member 246. They are thereafter secured in coaxial engagement, such as via welding, soldering, or use of adhesives. The tubular member 246 and core member 243 may be of like materials, or may dissimilar, such as by providing one of stainless steel, and the other of nickel titanium, in which case of course the chosen fixation means may require customization for these dissimilar metals, such as for example certain adhesives or solders (generally don't weld well together, but such is a further contemplated mode and may be suitable in certain circumstances). Tip 244 typically includes a shapeable member internally therein, e.g. a flat ribbon or flat portion of the distal core 243, and the outer coil 248 in that region is typically radiopaque for x-ray visualization, e.g. platinum or tungsten or gold coil, with an atraumatic distal tip such as a smooth ball-shaped solder or weld cap.

[00183] Another embodiment shown in FIGS. 9A-C provides a filter assembly 200 with a filter member 201 secured to a tubular spine member 210 that includes a tubular wall 211 that includes along its internal diameter an adjustable lock in another form of expandable membrane that is adjusted from a first position that is radially expanded relative to a guidewire 40 (FlG. 9A), to a second position that is radially collapsed diameter relative to guidewire 40 (FIGS. 9B-C) as follows. Internal liner 213 is laminated or otherwise secured to tubular wall 211 in a manner providing a baffle or unlaminated pouch or reservoir 218 that is coupled to a duck-bill valve 220 along end 216 of the tubular member 210. An actuator assembly 230 includes a removably engaged inflation member 236 shown in FIG. 9B that is inserted within duckbill valve 220 and is coupled to a source of pressurizeable fluid 232 externally of the patient. In this arrangement, pressurization of reservoir 218 expands the wall of the reservoir toward the interior of tubular wall 211 , thus reducing the effective inner diameter to lock onto guidewire 40. Thereafter, inflation member 236 is removed at which time the duckbill valve 220 shuts from the eternal pressure experienced within reservoir 218, locking the assembly onto guidewire 40 permanently for unitary manipulation. [00184] The particular arrangement shown is illustrative, and it is to be appreciated by one of ordinary skill that modifications may be made to suit a particular purpose without departing from the intended scope hereof. For example, duckbill valve 220 may be moved to the opposite side of tubular spine 210, to provide a different relative orientation for coupling to the actuator assembly 230 relative to the orientation of filter member 201. This may be modified in this manner for example for antegrade delivery such that the proximal end 212 is located downstream of the flow path into filter member 201 , as would be apparent to one of ordinary skill. [00185] A further aspect of this disclosure is shown in FIGS. 10A-D and provides a filter system 250 that is a "rapid exchange" type of system that incorporates a moveable cuff 280 that is used to adjust the filter member 280 between radially collapsed and radially expanded configurations, respectively, and is further described by these and other features as follows. [00186] Filter assembly 250 includes a filter member 288 that is secured to a support spine 260. Filter member 288 includes a sheet or membrane of similar shape to prior tapered embodiments with one open end and one closed end, but includes a plurality of circumferentially spaced splines 288 that have shape memory in a radially expanded condition that corresponds with a radially expanded configuration for the filter member 280, as shown in shadow in FIG. 1OB. However, filter member 280 is held with splines 288 elastically deformed in a radially collapsed condition corresponding with a radially collapsed configuration for the filter member 280 when engaged within an interior of moveable cuff 270, as shown in FIG. 10A and 10B.

[00187] As further shown in FIG. 10A, support member 260 includes a plurality of lumens within which are various coupling members having various functions and arrangements as follows. Lumen 268 carries a longitudinal spline 272 that is coupled at its distal end to adjustable cuff 270 and its proximal end (not shown) extends externally from the body for remote manipulation, either manually or by an actuator as would be apparent to one of ordinary skill. Another guidewire lumen extends between proximal and distal ports 262,264 that are both located on the distal end of the support member 260 on proximal and distal sides, respectively, of filter member 280. This provides for "rapid exchange" or "monorail" type of engagement over guidewire 254, such that the proximal end of guidewire 254 may be "backloaded" through distal port 264 and out proximal guidewire port 262 while the distal end of the guidewire 254 is located within the body, such as at or beyond the desired filter location. [00188] A proximal portion of member 260 carries other lumens and extends proximally from proximal port 262 outside the body for remote manipulation to advance filter member 280 over guidewire 254 to the desired filter location. An array of distal ports 266 are circumferentially spaced around support member 260, and extend proximally therefrom to a proximal end portion of member 260 outside the body. Through distal ports 266 extend a plurality of tethers 276 that are coupled circumferentially around filter member 280, as shown in FIG. 10A and in shadow in FIG. 10B. Tethers 276 extend proximally from distal ports 266 along member 260, through multiple lumens, to a proximal location for remote manipulation externally of the body in order to control re-collapse of filter member 280 as explained in further detail below. [00189] As illustrated in FIG. 10B, the filter member 280 is adjustable from a collapsed configuration with a collapsed outer diameter od to an expanded outer diameter OD. This is accomplished by proximal withdrawal of longitudinal spline 272 that withdraws' cuff 270 proximally from filter member 280, releasing filter member 280 from radial confinement and allowing for memory recovery of support splines 288 to the expanded condition. This is shown in detail in FIG. 10C. In this expanded configuration, filter member 280 is adapted to span across a substantial cross-section of the body lumen where it is delivered, and is constructed with such porosity so as to filter components from blood flow above a pre-determined size, such as debris from upstream interventions. As such, filter member 280 may reconfigure its shape under the mass of such debris, as shown in shadow in FIG. 10C. [00190] As further shown in FIG. 10C, tethers 276 are strung between the expanded proximal open end of filter member 280 in the expanded configuration and ports 266. Subsequent to the filtering operation in-vivo, the assembly 280 is to be withdrawn while capturing its contents therein. According to the present embodiment, this is accomplished by withdrawing tethers 276 through circumferential ports 266, which draws down the proximal open end of filter member 280 onto support member 260. As further shown in FIG. 10D, contents may leave a bulging drawn down condition for filter member 280, which may or may not fit into a respective delivery or introducer sheath; if it does fit, the system 250 is withdrawn from the body therethrough. If it does not so fit, then system 250 is removed together with the respective sheath.

[00191] It is to be appreciated that several advantages are achieved with the foregoing embodiments of FIGS. 10A-D in comparison with certain other embodiments. In one regard, the relatively short cuff 270 replaces the need for the adjustable delivery sheath 50 of prior embodiments that otherwise generally extends over all the deliver member components for the respective filter assembly and proximally through the vascular introduction site. This provides for a lower profile overall system. In another regard, the rapid exchange feature allows for substantial benefit for advancing the filter assembly distal to an intervention site, while freeing the guidewire to provide a rail proximal thereto for advancement of other catheters to the site of intervention, such as a balloon angioplasty, stenting, or atherectomy or thrombectomy device. In still a further regard, the retractable tethers provide a desirable mode for providing tight capture of the debris laden filter member onto the respective support member, aiding in low profiles for efficient withdrawal. [00192] Accordingly, such features provided are considered independently beneficial broad aspects illustrated by the present embodiment, which are to be considered of independent value, in addition to their various combinations and sub-combinations. [00193] "Rapid exchange" features may also be incorporated in lockable filter assemblies similar to the present embodiments, whether shown or not, as a complete review of the present disclosure would be applied by one of ordinary skill. One highly beneficial illustrative example is provided as follows by reference to FIGS. 11A-C. [00194] FIG. 11A shows a filter system 300 that includes a filter assembly 320 cooperating with a delivery member 350 and guidewire 340. Delivery member

350 includes a proximal shaft portion 351 and a distal shaft portion 355. Proximal shaft portion 351 provides a tubular wall around a lumen 353 that further extends along distal shaft portion 355. However, distal shaft portion 355 further includes a second wall 352 that forms a second lumen 356 extending between proximal and distal ports 358,359, respectively that are both along the distal end portion of the member 350. Lumen 356 is thus a guidewire lumen that slideably engages a guidewire 340 in a "rapid exchange" or "monorail" fashion. [00195] Filter assembly 320 is shown in FIGS. 11A-B in a radially collapsed configuration housed within lumen 356 and is engaged in a friction fit therein, and also held in place via coupler 364 located within lumen 353 and coupled to filter assembly 320 through port 354 between lumens 353,356. Filter assembly 320 may take many different forms, though in the particular embodiment shown is similar for illustration purposes to the embodiments shown and described by reference to FIGS. 1A-2B. Though not shown here in detail for clarity purposes, but by reference to applicable combination with the features revealed among the other FIGS, herein shown and described, filter assembly 320 includes a guidewire lumen through a support spine coupled to a filter member, and such guidewire lumen is also coaxially engaged over guidewire 340 as shown in FIGS. 11A-C.

[00196] Accordingly, by advancing proximal end portion of the delivery member 350 externally of the body, lumen 356 and the coaxially engaged guidewire lumen of the filter assembly 320 track over the guidewire to a desired location within the body. Thereafter, filter assembly 320 is adjusted to lock onto the guidewire 340, which may be for example via actuation of a lock mechanism with an applied energy via coupler 364. Thereafter, coupler 364 is detached from filter assembly 320 that has become unitary with guidewire 340 for manipulation purposes. This may be done for example by electrolytically detaching the coupling joint 366 (FIG. 11A) according in further examples to one or more of the various mechanisms herein described. Thereafter, distal end 365 of coupler 364 is retracted through port 354, as shown in FIG. 11B. [00197] As shown in FIG. 11 C, delivery member 350 may then be proximally retracted relative to guidewire 340 and locked filter member 320, thus removing filter member 320 from radial confinement and allowing filter member 320 to radially expand to the radially expanded configuration shown in FIG. 11C that is adapted to span across a lumen for filtering predetermined sized components of flow therethrough. Following completion of the filtering operation, the cuff portion forming lumen 356 may be again advanced distally to groom back down the filter assembly 320 to capture the contents therein for removal (not shown). Or, another mechanism may be employed to adjust the filter assembly 320 back to radially collapsed position and/or remove the filtered contents.

[00198] It is to be appreciated that the foregoing embodiments of FIGS. 11A-C are highly beneficial, though illustrative of broader contemplated aspects that may be achieve by many other modes without departing from the presently intended broad scope of the various aspects made apparent to one of ordinary skill by this disclosure. For example, as shown in FIG. 12, lumen 353 may be terminated more closely distally adjacent to port 366. This results in a lower distal profile for the region of the overall assembly housing filter member 320, and thus one difference between FIGS. 11 and 12 is that the profile of the radially confining outer sheath area around the housed filter assembly is reduced as the lumen that carries the conductor lead to the filter device locking cuff is terminated immediately distally from the coupling. This provides a substantial benefit for example for distal embolic filters that used in a manner and environment requiring that they must first cross occlusions prior to being deployed for filtering.

[00199] As also shown for further illustration in FIG. 12, one or more markers 370 may be provided on delivery member 350 for the purpose of providing indicia regarding the relative position of the delivery member 350 with respect to the underlying filter member 320. It is also to be appreciated that the particular configuration shown for filter member 320 is illustrative for clarity in the present embodiments, and other forms of filter member 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. [00200] 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.

[00201] 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 of the FIGS, provided herein schematically show an 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 the monopolar embodiments shown, 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 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.

[00202] The conductor of the various embodiments, e.g. as for example coupling member 36 shown in FIGS. 1A-C, may be detachable, as such component becomes unnecessary after locking the respective filter module onto the wire. This may be done 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. [00203] Monopolar embodiments are variously provided for illustration of the electrically energized embodiments. However, where not shown they 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.

[00204] 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, FIGS. 4A-B show an adjustability along the entire length of a support tubular member for locking onto the guidewire, whereas FIGS. 5A-6B show alternative embodiments with more localized regions of radial adjustability for guidewire locking. 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). [00205] In another regard, various of the embodiments, such as for example among FIGS. 1 A-6B, show an outer adjusting sheath as separate from the 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, such as shown in FIGS. 10A-12.

[00206] Embolic filter devices according to the invention, 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.

[00207] 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. [00208] 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. [00209] 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.

[00210] 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. [00211] 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. [00212] The various embodiments described above 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 lumen, 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.

[00213] 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.

[00214] 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.

[00215] Other applications may include adjustable annular collars used to lock down over centrally located devices extending within their bore. 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.

[00216] It is to be appreciated that, despite various particular benefits of the specific embodiments described elsewhere hereunder, further aspects and highly beneficial adjustable embolic filter assemblies are also contemplated.

Several such additional aspects are described as follows. [00217] FIGS. 13A-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. [00218] FIG. 13A 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. [00219] FIG. 13B 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 schematically, adjustable lock assembly 420 comprises a network of interconnected struts 422 that are separated by gaps 424 left by the laser cutting. These struts 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 struts 422,432 are elsewhere herein described in further detail. [00220] It is to be appreciated that tube 410 in the initially cut configuration shown in FIG. 13B 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. 13A, 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. 13B. 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 "enclosed" along that length. [00221] After the cutting operation and the respective patterned regions are formed as schematically shown in FIG. 13B, 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. 13C₁ and which is described in further detail as follows.

[00222] FIG. 13C 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. 13C. This constitutes the open or delivery configuration for the adjustable lock assembly 420.

[00223] Accordingly, it is to be appreciated that the adjustable locking assembly 420 is initially provided at 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. [00224] FIG. 13C 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. 13B) is reduced to I2 (FIG. 13C). 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. 13C 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. 13C, 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.

[00225] 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 open 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. [00226] The particular tubing used to form this integrated support scaffold shown in FIGS. 13A-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 .016" or .017" 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 in pictures in FIGS. 15A-16C). 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. [00227] 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 elastomer 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. [00228] 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. 14. FIG. 14 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. [00229] 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.

[00230] Also shown in FIG. 14, adjustable filter module 550 has a similar construction as that previously described by reference to FIG. 13C. Filter module 550 includes an adjustable lock assembly 560 with a plurality of cooperating nickel-titanium struts in a network that has an adjustable diameter as previously described above. 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. 13C. Also included is a porous filter member 574 supported by splines 572. [00231] 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. [00232] 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 struts 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 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, 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. [00233] 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.

[00234] 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. 14A 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. [00235] 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. 14, 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.

[00236] 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. 13C. This deploys the porous filter membrane 574 across the vessel at the filtering location for efficient filtering of blood emboli. [00237J 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 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 562 to groom expanded filter assembly 560 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. [00238] 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 French, and in further embodiments less than about 2.7 French, and still more particularly in certain circumstances less than about 2.5 and even about 2.3 French, would be in particular highly desirable for many cases. In this setting, high strength, thin-walled tubings are highly desirable. And, in many cases, composite tubing constructions may be of particular benefit. [00239] 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. 14 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. 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. [00240] 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. [00241] In particular, FIG. 15A shows an integrally formed filter scaffold body

550 with an adjustable lock assembly 560 in the form of a self-collapsing stent coupled integrally with a self-expanding filter support scaffold 570 shown in the expanded configuration. The NiTi collapsing stent lock assembly 560 is held in an open configuration over a polyimide inner member 510 with approximately .017" ID and approximately .022" OD. This partial assembly is shown slideably engaged over a .014" guidewire 580 for reference. [00242] FIG. 15B shows a picture of the assembly shown in FIG. 15A after withdrawal of the filter module 550 retained over the inner member 510 into the inner lumen 523 of distal end portion 524 of an outer member 520 in a completed delivery assembly for the system. Though only outer member 520 is visible in the picture, a braided polyimide proximal end portion 522 and unbraided and more flexible and trackable simple polymeric tubular distal end portion 524 are indicated as joined at joint 528 where a radiopaque visible band is located. [00243] FIG. 15C shows the filter assembly 550 deployed distally from the distal end portion 524 of outer member 520 of the delivery assembly. This picture shows the assembly following release of the internal lock assembly 560 from the inner member retainer 510 (not shown, as positioned left of the pictorial view) and onto the guidewire 580. [00244] According to a further mode, one system and method for retrieving the adjustable locking filtering system just described by reference to FIGS. 15A-C is described for further illustration as follows by reference to FIGS. 16A-C.

[00245] FIG. 16A shows the locked and released filter module 550 on the guidewire 580 as a second capture sheath 590 is being advanced over the guidewire 580 toward the locked filter assembly 550 to slide over lock assembly 560 and radially extended filter member 570. [00246] FIG. 16B shows the capture sheath 590 further advanced over lock assembly 560 and partially engaged for grooming the filter support scaffold

570 into the inner capture lumen 591. [00247] FIG. 16C shows the capture sheath 590 still further advanced with full capture of the filter support scaffold 550 within the capture lumen 591. As shown in more particular detail, this particular embodiment for capture sheath

590 includes a relatively lower outer diameter proximal end portion 592 joined to a larger distal diameter distal end portion 594 via a joint 598 in the region of a radiopaque marker band 596. This system allows for optimally low profile along the smaller diameter proximal end portion as is generally desirable for translumenal procedures, whereas the distal end portion 594 is given a larger diameter to accommodate capture and housing of the filter assembly 550.

These may also be different materials, including in one arrangement a higher modulus material for the proximal end portion and lower modulus for the larger distal end portion to accommodate desirable pushability and trackability at the different regions along the length.

[00248] It is to be appreciated that the foregoing pictures are provided for a more complete understanding of the various components elsewhere herein described by reference to illustrative drawings. Though a filter membrane is not included in the 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.

[00249] FIGS. 17A-C show still further aspects, modes, and embodiments of present invention that are also herein contemplated in context of a reference vessel or lumen. 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. [00250] 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. [00251] Accordingly, the dynamic coupler 630 shown in FIG. 17A 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. As the guidewire 660 moves proximally along the vessel during a procedure (FIG. 17B), 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. 17B) from resting position a (shown in shadow in FIG. 17B 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.

[00252] For further illustration, an opposite relative motion scenario with distally advancing guidewire 660 is illustrated in FIG. 17C, 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.

[00253] 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. 13A-C, wherein the dynamic coupler is given the form of a patterned spring structure cut into the nickel- titanium hypotube. [00254] 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. 17D, which is shown in 2 dimensions as if the tubular member after patterning is cut longitudinally and laid flat on the page. 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. [00255] The provision of the present embodiment 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.

[00256] Additional aspects of invention also considered to provide significant benefit to improved medical care are illustrated in FIGS. 18A-G and described as follows. 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. [00257] 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. [00258] Accordingly, FIG. 18A 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 and 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.

[00259] FIG. 18B shows this system 700 after successful crossing through the CTO 702 and into the distal lumen 706. FIG. 18C 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. [00260] As shown in FIG. 18D, 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. 18D. [00261] Subsequent sequential steps of recanalization intervention by deploying a stent 770 to open the blockage 702 are shown in FIGS. 18E-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. 18F, 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. 18G.

[00262] 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.

[00263] 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. [00264] It is to be appreciated that these 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. [00265] Another aspect of invention also herein contemplated is shown in the system 800 illustrated in FIGS. 19A-B. System 800 provides an adjustable guidewire-locking filter assembly 810 that employs a glue to lock a filter assembly 802 to a guidewire (not shown) as follows. [00266] More specifically, a filter support body 812 is shown in FIG. 19A with an injection lumen 814 having a threaded portion 816 and that is formed for example within a gap area 818 which is a space left un-bonded between two otherwise laminated tubings 820,822. An inner port 819 communicates between the gap area 818 and the inner guidewire lumen 824 of the tubular support body 812 where a guidewire (not shown) is to be slideably engaged. A threaded delivery needle 830 comprises a needle shank 832 which includes a threaded portion 836 along its distal end portion 834, as is also shown in FIG. 19A. For clarity of description for the other components associated with locking and delivery the filter assembly 800, filter member 802 is shown in only partial view to reveal only the coupling between two end portions 804,806 of a filter membrane support loop or scaffold to filter body 812. This may be done in a number of ways, though in the beneficial embodiment shown the two ends 804,806 are secured between laminated walls 820,822 of body 812. More specifically, the ends 804,806 are bent in a memory shape at this coupling to allow for radial extension of the support scaffold (and supported filter membrane, not shown) during release from confinement as described below. The coupling to the laminated walls may be accomplished for example by forming holes through the outer tubing 820 through which the ends 820,822 are placed while inner tubing 822 is placed within the interior of that outer tubing 820. In this matter, ends 804,806 are placed between the tubings prior to lamination, and are secured in place upon heat, solvent, or adhesive bonding between tubings 820,822. Further shapes or pores may be provided to ends 804,806 where held within the laminate, in order to provide robust integrity with enhanced retention such as to strengthen resistance to "pull-out" upon an applied tension force. Threaded portion 836 is adapted to mate in a releasable threaded engagement with the threaded portion 816 of lumen 814 through a delivery member, such as described below by reference to FIG. 19B. Thus, FIGS. 19A and 19B are to be reviewed in context together. [00267] A delivery assembly 840 adapted for cooperative use together with the system 800 shown in FIG. 19A is shown in FIG. 19B. Delivery assembly 840 includes a delivery member 841 coupled to an outer member or housing 850. Delivery member 840 comprises a tubular body 842 with a delivery lumen 844 and is coupled to outer member 850. Outer member 850 comprises a tubular wall 852 with an inner housing lumen 854. Housing lumen 854 is coupled to delivery member 844 with delivery lumen 844 communicating with housing lumen 854.

[00268] Housing lumen 854 is also adapted to house the self-expanding filter assembly 800 in a radially collapsed configuration during delivery and in a particular orientation. According to this orientation, injection lumen 814 is aligned and registered with delivery lumen 844 such that needle 830 advanced distally from delivery lumen 844 is adapted to engage lumen 814 by threaded engagement between threaded portion 816 and threaded portion 836. In addition, assembly 800 when housed within housing lumen 854 is oriented with guidewire lumen 824 aligned with proximal and distal ports 856,858 of housing lumen 854. This allows for the combined system of (a) delivery assembly 840, plus (b) filter assembly 800 housed in housing lumen

854 and threaded with needle 830 via delivery member 841 , to be together slideably engaged with and track over a guidewire that extends through guidewire lumen 824 and ports 856,858. [00269] In addition, it is to be appreciated that needle 830 further includes a proximal end portion that is adapted to be coupled to a glue source, shown schematically in FIGS. 19A-B as source 860, during or after guidewire tracking of the combined system to the filtering location of interest.

[00270] Once delivered to the filtering location in the orientation just described, the needle 830 injects a glue from source 860 that exits distal port 838, and flows through internal port 819 and into the inner lumen 824 surrounding the guidewire. The inner lumen 824 thereby bonds the guidewire via the glue that adheres the two together. This takes place with filter assembly 800 still housed within housing 850. Either before curing or after, the threaded needle 830 is then unthreaded from the threaded lumen 814, and the delivery assembly 840 is then withdrawn proximally against longitudinal resistance applied to the guidewire. As the tubular body 812 is locked to the guidewire, this releases the filter assembly 800 from within the outer member housing 850 for self-expansion and filtering of blood emboli.

[00271] The "glue" herein described may be any injectable material that results in a locking between the tubular member 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 to 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 the lumen, 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 or otherwise responds to fill the interface sufficient to lock the guidewire to the inner lumen of the filter support housing. [00272] 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, needle 841 may be include dual lumens that allow for separation of the components until they mix in situ, which may be expelled to mix either in gap area 818 or lumen 824, or may include a mixing reservoir at the tip area 834 of needle 830. 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.

[00273] 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.

[00274] 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; and WO 2006/084256 to Peacock.

[00275] 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. [00276] 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.

[00277] 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. [00278] 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."

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 adjustable, integral scaffold body that comprises an adjustable guidewire lock assembly integral with an adjustable filter support scaffold; and a filter member coupled to the adjustable filter support scaffold; wherein the adjustable integral scaffold body in a first configuration is adapted to slideably engage and track over a guidewire to the location with the guidewire lock assembly in an open configuration, and with the adjustable filter support scaffold in a radially collapsed configuration such that the filter member spans a first diameter; and wherein at the filtering location the adjustable integral scaffold body is adjustable to a second configuration with the guidewire lock assembly adjusted to a locked configuration that is adapted to substantially lock onto the guidewire, and with the adjustable filter support scaffold adjusted to a radially extended configuration such that the filter member spans a second diameter that is greater than the first diameter and that is adapted to engage a wall of the lumen at the location.

2. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: a filter member; means for delivering the filter member over a guidewire to the location; means for adjusting the filter member at the location between a radially collapsed configuration that spans a first diameter and a radially extended configuration that spans a second diameter; means for substantially securing the filter member relative to the guidewire in situ at the location; and means for supporting the filter member in the radially extended configuration at the location; wherein the means for substantially securing the filter member to the

Claims

guidewire and the means for supporting the filter member in the radially extended configuration at the location are integral.

3. The system of claim 2, wherein: the means for substantially securing the filter member to the guidewire comprises an adjustable guidewire lock assembly that is adjustable between an open configuration that tracks over a guidewire and a locked configuration that locks onto a guidewire; the means for supporting the filter member comprises an adjustable filter support scaffold that is adjustable between a radially collapsed configuration that spans a first inner diameter and a radially extended configuration that spans a second diameter that is greater than the first diameter; the adjustable guidewire lock assembly and adjustable filter support scaffold together comprise one integral scaffold body; and the scaffold body is adjustable between a first configuration, which corresponds with the open configuration for the lock assembly and the radially collapsed configuration for the filter support scaffold, and a second configuration, which corresponds with the locked configuration for the lock assembly and the radially extended configuration for the filter support scaffold.

4. The system of claim 1 or 3, wherein the integral scaffold body comprises an integral piece of material of unitary construction in a patterned shape across the adjustable guidewire lock assembly and adjustable filter support scaffold.

5. The system of claim 4, wherein the integral piece of material comprises one continuous wire filament in the patterned shape.

6. The system of claim 4, wherein the integral piece of material comprises a shape memory material.

7. The system of claim 6, wherein the scaffold body is adjustable at the location from the first configuration to the second configuration by superelastic recovery force of the shape memory material from a superelastically deformed shape that characterizes the first configuration toward a memory shape.

8. The system of claim 6, wherein the scaffold body is adjustable at the location from the first configuration to the second configuration by heating the shape memory material above a transition temperature.

9. The system of claim 4, wherein: the integral piece of material comprises a substantially tubular wall along the lock assembly; the substantially tubular wall has a memory shape with a first inner diameter; in the open configuration the substantially tubular wall is retained open in a radially expanded condition with a second inner diameter under an applied force from the memory shape, wherein the second inner diameter is larger than the first inner diameter; and the substantially tubular wall when released from the applied force self- collapses under a material recovery force toward the memory shape.

10. The system of claim 9, wherein the substantially tubular wall in the locked configuration has a third inner diameter in confronting engagement with an outer surface of the guidewire and that is greater than the first inner diameter and less than the second inner diameter.

11. The system of claim 9, wherein the substantially tubular wall comprises a voided pattern of nickel-titanium material around an interior passageway.

12. The system of claim 9, further comprising: a delivery assembly that comprises an adjustable lock retainer; wherein the lock retainer is adjustable between a first condition wherein the adjustable guidewire lock assembly is retained in the open configuration under an applied force from the lock retainer and a second condition wherein the adjustable guidewire lock assembly is released from the adjustable lock retainer and self- collapses to the locked configuration under force of material recovery to the memory shape.

13. The system of claim 9, wherein the integral piece of material comprises a patterned shape cut from a nickel-titanium tube.

14. The system of claim 4, further comprising: a delivery system that comprises a filter support scaffold retainer; and wherein the filter support scaffold retainer is adjustable between first and second conditions relative to the adjustable filter support scaffold such that in the first condition the adjustable filter support scaffold is retained in the radially collapsed configuration, and in the second condition the filter support scaffold is released to self-expand to the radially extended configuration.

15. The system of claim 6, further comprising: a delivery assembly that comprises a guidewire lock retainer and a filter support scaffold retainer; wherein the guidewire lock retainer cooperates with the adjustable guidewire lock assembly and is adjustable between a first condition corresponding with the first configuration and wherein the adjustable guidewire lock assembly is retained in the open configuration under an applied force from the guidewire lock retainer, and a second condition corresponding with the second configuration and wherein the adjustable guidewire lock assembly is released from the adjustable guidewire lock retainer and self-collapses to the locked configuration under a force of material recovery to a first memory shape; and wherein the filter support scaffold retainer is adjustable between a first condition corresponding with the first configuration and wherein the adjustable filter support scaffold is retained in the radially collapsed configuration, and a second condition corresponding with the second configuration and wherein the filter support scaffold is released to self-expand to the radially extended configuration under a force of material recovery to a second memory shape.

16. The system of claim 15, wherein: the guidewire lock assembly retainer comprises an inner tubular member; the filter support scaffold retainer comprises an outer tubular member with a retention lumen extending along a length relative to a longitudinal axis; in the first configuration the inner tubular member is positioned at a first longitudinal position within the outer tubular member; and in the second configuration the inner tubular member is withdrawn from the first longitudinal position to a second longitudinal position that is proximal from the first longitudinal position relative to the outer tubular member.

17. A method for manufacturing an embolic filter assembly for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: forming a scaffold body that comprises an adjustable guidewire lock assembly and an adjustable filter support scaffold; wherein the scaffold body is formed from one integral piece of material in a patterned shape across the adjustable guidewire lock assembly and adjustable filter support scaffold.

18. The method of claim 17, further comprising cutting the scaffold body into the patterned shape from a precursor material.

19. The method of claim 17, further comprising cutting the scaffold body from a tube of shape memory material into a first patterned memory shape.

20. The method of claim 19, wherein the shape memory material comprises nickel-titanium.

21. The method of claim 19, further comprising retraining the cut scaffold body from the first patterned memory shape to a second patterned memory shape that is different than the first patterned memory shape.

22. The method of claim 21 , further comprising: providing the guidewire lock assembly with a substantially tubular member having a first inner diameter in the first patterned memory shape; and retraining the substantially tubular member of the guidewire lock assembly to the second patterned memory shape having a second inner diameter that is less than the first inner diameter.

23. The method of claim 21 , further comprising: providing the integral piece of material along the guidewire lock assembly with a substantially tubular structure having an inner guidewire passageway; positioning an adjustable lock retainer at a first position within the inner guidewire passageway so as to radially expand and deform the substantially tubular structure to a superelastically deformed shape with a radially expanded inner diameter from a memory shape with a radially collapsed inner diameter that is less than the radially expanded inner diameter; wherein the expanded inner diameter corresponds with an open configuration for the adjustable guidewire lock assembly that is configured to slideably engage and track over a guidewire; and wherein the lock retainer is adjustable from the first position to a second position that is removed from the inner guidewire passageway so as to allow the substantially tubular member to self-collapse under a material recovery force radially inward from the deformed shape with the radially expanded inner diameter toward the memory shape with the smaller radially collapsed inner diameter.

24. The method of claim 23, further comprising: positioning a guidewire within the inner guidewire passageway when the lock retainer is in the first position and the guidewire lock assembly is in the open configuration; retaining the guidewire within the inner guidewire passageway while adjusting the lock retainer to the second position; wherein the guidewire has an outer diameter that is greater than the radially collapsed inner diameter corresponding with the memory shape for the substantially tubular member of the guidewire lock assembly; allowing the substantially tubular member of the guidewire lock assembly to confront and compress onto the guidewire under the material recovery force of recovery radially inward from the deformed shape and toward the memory shape; and wherein the guidewire lock assembly compressed onto the guidewire corresponds with a locked condition wherein the guidewire lock assembly is substantially locked onto the guidewire.

25. The method of claim 24, wherein: the lock retainer comprises a tubular member with a guidewire lumen; and the guidewire is positioned within the guidewire lumen.

26. The method of claim 17, further comprising: positioning an outer retention sheath of an adjustable filter support scaffold retainer at a first position around the adjustable support scaffold so as to radially confine the adjustable filter support scaffold to a superelastically deformed shape in a radially collapsed configuration with a radially collapsed outer diameter from a memory shape with a radially extended outer diameter that is greater than the radially collapsed outer diameter; wherein the radially collapsed configuration for the support scaffold corresponds with a first configuration for the scaffold body and with the guidewire lock assembly in an open configuration such that the scaffold body is configured to be delivered to a location within a lumen of a patient's body slideably over a guidewire; adjusting the filter support scaffold retainer from the first position to a second position that is removed from the adjustable filter support scaffold to thereby allow the adjustable filter support scaffold to self-expand to a radially extended configuration under a material recovery force radially outward from the deformed shape with the radially collapsed outer diameter toward the memory shape with the larger radially extended outer diameter.

27. The method of claim 25, further comprising: positioning an outer retention sheath of an adjustable filter support scaffold retainer at a first position around the adjustable support scaffold so as to radially confine the adjustable filter support scaffold to a superelastically deformed shape in a radially collapsed configuration with a radially collapsed outer diameter from a memory shape with a radially extended outer diameter that is greater than the radially collapsed outer diameter; wherein the radially collapsed configuration for the support scaffold corresponds with a first configuration for the scaffold body and with the guidewire lock assembly in an open configuration such that the scaffold body is configured to be delivered to a location within a lumen of a patient's body slideably over a guidewire; adjusting the filter support scaffold retainer from the first position to a second position that is removed from the adjustable filter support scaffold to thereby allow the adjustable filter support scaffold to self-expand to a radially extended configuration under a material recovery force radially outward from the deformed shape with the radially collapsed outer diameter toward the memory shape with the larger radially extended outer diameter; and positioning the tubular member of the lock retainer within the outer retention sheath.

28. The method of claim 27, further comprising: positioning each of the guidewire lock assembly retained by the guidewire lock retainer in the open condition, and the filter support scaffold retained by the outer retention sheath in the radially collapsed configuration, within the outer retention sheath.

29. The method of claim 28, further comprising: positioning a guidewire within the guidewire lumen and extending distally from the outer retention sheath while the guidewire lock assembly is retained in the open condition by the lock retainer and the filter support scaffold is retained in the radially collapsed configuration within the outer retention sheath.

30. The method of claim 28, further comprising: providing a stop within the outer retention sheath such that upon proximal withdrawal of the tubular member of the lock retainer relative to the outer retention sheath the guidewire lock assembly confronts the stop and is prevented from withdrawing with the tubular member, such that the tubular member may be withdrawn from the inner guidewire passageway of the lock assembly.

31. The method of claim 17, further comprising: coupling a radiopaque material to the integral piece of material along at least one of the lock assembly and the filter support scaffold.

32. The method of claim 17, further comprising: coupling the filter support scaffold to a filter member that is configured to filter emboli from fluid flowing through the filter member when the filter member is supported by the filter support scaffold at a location across a lumen in a patient's body.

33. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: an adjustable embolic filter module comprising a guidewire lock assembly and an embolic filter assembly; wherein the adjustable embolic filter module in a first configuration is adapted to slideably engage and track over a guidewire to the location with the guidewire lock assembly in an open configuration and with the embolic filter assembly in a radially collapsed configuration with a first diameter; wherein the adjustable embolic filter module is adjustable at the location to a second configuration with the guidewire lock assembly in a locked configuration that is adapted to substantially lock onto the guidewire, and with the embolic filter assembly in a radially extended configuration that spans a second diameter that is greater than the first diameter and that is adapted to engage a wall of the lumen at the location; and wherein in the second configuration at the location the adjustable embolic filter module is further adapted to allow limited relative motion between the guidewire lock assembly in the locked configuration and the embolic filter assembly in the radially extended configuration in response to an applied force to at least one of the guidewire lock assembly and the embolic filter assembly.

34. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: an adjustable embolic filter module comprising a guidewire lock assembly and an embolic filter assembly; wherein the adjustable embolic filter module in a first configuration is adapted to slideably engage and track over a guidewire to the location with the guidewire lock assembly in an open configuration and with the embolic filter assembly in a radially collapsed configuration with a first diameter; wherein the adjustable embolic filter module is adjustable at the location to a second configuration with the guidewire lock assembly in a locked configuration that is adapted to substantially lock onto the guidewire, and with the embolic filter assembly in a radially extended configuration that spans a second diameter that is greater than the first diameter and that is adapted to engage a wall of the lumen at the location; and means for allowing limited relative motion between the guidewire lock assembly in the locked configuration and the embolic filter assembly in the radially extended configuration in response to an applied force to at least one of the guidewire lock assembly and the embolic filter assembly in the second configuration at the location.

35. The system of claim 33 or 34, further comprising: a dynamic motion coupler extending between the guidewire lock assembly and the embolic filter assembly.

36. The system of claim 35, wherein the dynamic motion coupler comprises a spring extending between the guidewire lock assembly and the embolic filter assembly.

37. The system of claim 35, wherein the dynamic motion coupler comprises a tether extending between the guidewire lock assembly and the embolic filter assembly.

38. The system of claim 35, wherein: the filter assembly comprises a filter support scaffold; and the guidewire lock assembly, the filter support scaffold, and the dynamic motion coupler are integral and comprise a single unitary piece of material in a patterned shape.

39. The system of claim 38, further comprising a filter member coupled to the filter support scaffold.

40. The system of claim 38, wherein the piece of material comprises a cut tube of shape memory material.

41. A method for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: providing an adjustable embolic filter module comprising a guidewire lock assembly and an embolic filter assembly; advancing a guidewire to the location; slideably engaging the adjustable embolic filter module in a first configuration over a guidewire; tracking the adjustable embolic filter module in the first configuration over the guidewire to the location; adjusting the embolic filter module from the first configuration to a second configuration by locking the guidewire lock assembly onto the guidewire so as to substantially secure the adjustable embolic filter module to the guidewire at the location, and by radially extending the embolic filter assembly to engage a blood vessel wall at the location; with the embolic filter module in the second configuration at the location, applying a force to at least one of the guidewire lock assembly and the embolic filter assembly; and allowing limited relative motion between the guidewire lock assembly locked onto the guidewire and the radially extended embolic filter assembly engaged to the lumen wall in response to the applied force.

42. The method of claim 41 , wherein the limited relative motion is provided by a dynamic motion coupler extending between the guidewire lock assembly and the filter assembly.

43. The method of claim 42, wherein the dynamic motion coupler comprises a tether between the guidewire lock assembly and the filter assembly.

44. The method of claim 42, wherein the dynamic motion coupler comprises a spring.

45. The method of claim 41 , further comprising: moving the guidewire; and wherein the applied force is transmitted by the motion of the guidewire.

46. The method of claim 45, wherein moving the guidewire comprises moving the guidewire longitudinally in the lumen at the location, the applied force comprises a longitudinal applied force, and the limited relative motion comprises longitudinal relative motion.

47. The method of claim 46, wherein the longitudinal relative motion comprises collapsing a relative distance relative to the lock assembly and filter assembly.

48. The method of claim 46, wherein the longitudinal relative motion comprises extending a distance relative to the lock assembly and the filter assembly.

49. The method of claim 45, wherein moving the guidewire comprises rotating the guidewire, the applied force comprises a rotational force, and the limited relative motion comprises rotational relative motion.

50. A system for treating a tight occlusion in a patient's blood vessel and filtering emboli from blood distal to the occlusion in a patient's body, comprising: a vascular occlusion crossing system with a guidewire having a proximal end portion, a distal end portion, and an intermediate portion between the proximal and distal end portions, and also with at least one of an actuator or a sensor cooperating with the guidewire's distal end portion; an adjustable embolic filter assembly; and a delivery assembly coupled to the adjustable embolic filter assembly; wherein the vascular occlusion crossing system is adapted to advance the distal end portion of the guidewire across a blockage and to the filter location within the blood vessel at least in part by aid of the actuator or sensor; and wherein the delivery assembly is adapted to deliver the embolic filter assembly to a position along the distal end portion of the guidewire at the location; wherein the adjustable embolic filter assembly at the location is adapted to lock onto the guidewire and to be released from the delivery assembly in a configuration adapted to filter the emboli from the blood at the location; and wherein the adjustable embolic filter assembly and guidewire are adapted to be removed from the blood vessel together through a capture sheath.

51. A method for treating a patient suffering from a tight occlusion within a blood vessel in the patient's body while providing distal protection against blood emboli, comprising: providing a vascular occlusion crossing system with a guidewire and at least one of an actuator or a sensor cooperating with the guidewire; providing an adjustable embolic filter module; advancing the vascular occlusion crossing system across a tight occlusion in the blood vessel and to the location at least in part by aid of the actuator or sensor; slideably engaging the adjustable embolic filter module over the guidewire advanced to the location; tracking the adjustable embolic filter module over the guidewire to the location; locking the adjustable embolic filter module onto the guidewire at the location; filtering the emboli from the blood with the adjustable embolic filter module locked onto the guidewire; and removing the guidewire and adjustable embolic filter module locked onto the guidewire from the blood vessel through a capture sheath.

52. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: a guidewire having a proximal end portion and a distal end portion; at least one of an actuator and a sensor coupled to the guidewire; an adjustable embolic filter assembly; a delivery assembly coupled to the adjustable embolic filter assembly; wherein the distal end portion of the guidewire is configured to be positioned across the location with the proximal end portion extending externally from the patient; wherein the delivery assembly is configured to deliver the embolic filter assembly over the guidewire and to a position along the distal end portion of the guidewire at the location; wherein the embolic filter assembly is releasable from the delivery assembly at the position at the location such that the delivery assembly is removable from the patient independent of the embolic filter assembly; and wherein the embolic filter assembly when released from the delivery assembly at the position cooperates with the guidewire in a manner such that the embolic filter assembly is removable from the location by proximal withdrawal of the guidewire from the location into a capture sheath.

53. A method for filtering emboli from fluid at a location in a lumen within a patient, comprising: providing a guidewire; coupling at least one of an actuator or a sensor with the guidewire; providing an adjustable embolic filter module; advancing the vascular occlusion crossing system across a tight occlusion in the blood vessel and to the location at least in part by aid of the actuator or sensor; slideably engaging the adjustable embolic filter module over the guidewire advanced to the location; tracking the adjustable embolic filter module over the guidewire to the location; locking the adjustable embolic filter module onto the guidewire at the location; filtering the emboli from the blood with the adjustable embolic filter module locked onto the guidewire; and removing the guidewire and adjustable embolic filter module locked onto the guidewire from the blood vessel through a capture sheath.

54. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: a guidewire with a proximal end portion and a distal end portion with an enlarged distal tip; an embolic filter module with a guidewire lock assembly and a filter assembly that is adapted to be delivered over the guidewire to a position proximal of the tip and to be locked onto the guidewire at the position via the guidewire lock assembly.

55. A system for filtering emboli from fluid at a location within a lumen in a patient's body, comprising: a guidewire with a proximal end portion and a distal end portion with a distal tip; a delivery assembly; an embolic filter module that is deliverable with the delivery assembly over the guidewire to a position along the guidewire proximal of the enlarged distal tip and to be released from the delivery assembly at the position in coupled relationship with the guidewire; at least one of an actuator or a sensor coupled to the guidewire; and wherein the at least one of an actuator or sensor is configured to actuate or sense at least one property associated with the guidewire and other than in relation to the coupling relationship between the guidewire and the filter module.

56. The system of claim 50, 52, 54, or 55, comprising an actuator mechanically coupled to the guidewire for actuated motion of the guidewire.

57. The system of claim 56, wherein the actuator comprises a mechanical rotation assembly that mechanically spins the guidewire.

58. The system of claim 56, wherein the actuator comprises a mechanical translational assembly that moves the guidewire along a longitudinal axis.

59. The system of claim 56, wherein the actuator comprises a vibrational source that vibrates the guidewire.

60. The system of claim 50, 52, 54, or 55, comprising an actuator electrically coupled to the guidewire.

61. The system of claim 50, 52, 54, or 55, comprising an actuator configured to adjust the shape of the guidewiire in-situ.

62. The system of claim 50, 52, 54, or 55, comprising a sensor coupled to the guidewire in a manner configured to visualize or sense a property of at least one tissue structure within a region adjacent to the guidewire when the guidewire is positioned within the lumen.

63. An adjustable embolic filter system, comprising: a tubular body with a tubular wall that defines an inner guidewire lumen; a filter assembly coupled to the tubular wall and adjustable between a radially collapsed configuration and a radially extended configuration; and an imbedded lumen within the tubular wall and with a port through which the imbedded lumen communicates internally into the inner guidewire lumen.

64. The system of claim 63, further comprising: an injectable material delivery system coupled to the imbedded lumen and configured to inject an injectable material into the inner guidewire lumen through the port.

65. The system of claim 64, further comprising: an injectable material configured to be injected by the delivery system into the imbedded lumen and through the port into the guidewire lumen; and whereby the injected adhesive material is configured relative to the guidewire lumen and a guidewire dwelling therein so as to secure the tubular body to the guidewire.

66. The system of claim 64, further comprising: an injection needle with a proximal end portion configured to be coupled to a source of injectable material and a distal end portion having a threaded portion; wherein the imbedded lumen comprises a second threaded portion; and wherein the injection needle is configured to be releasably coupled to the imbedded lumen via threaded engagement between the first and second threaded portions.

67. The system of claim 66, wherein the needle comprises at least two lumens extending from a proximal coupler along the proximal end portion and into the distal end portion.

68. The system of claim 67, wherein the needle comprises a mixing chamber along the distal end portion in which the at least two lumens communicate.

69. The system of claim 67, further comprising a multi-part adhesive material comprising first and second component precursor materials that polymerize or cure upon mixing.

70. The system of claim 66, further comprising: a delivery assembly comprising a delivery member that comprises an elongated tubular body with a delivery lumen; and wherein the delivery member is configured to couple the injection needle to the imbedded lumen via the delivery lumen.

71. The system of claim 70, wherein the delivery assembly further comprises an outer cuff member with a tubular wall that defines an interior capture lumen, and the filter assembly is configured to be positioned within the interior capture lumen in the radially collapsed configuration and is releasable from the interior capture lumen to self-expand to the radially extended configuration via a material recovery force toward a memory shape.

72. The system of claim 1 , 2, 33, 34, or 63, further comprising a guidewire.

73. The system of claim 1 , 2, 33, 34, 50, 52, 54, 55, or 63, further comprising an atherectomy device.

74. The system of claim 1 , 2, 33, 34, 50, 52, 54, 55, or 63, further comprising a balloon catheter.

75. The system of claim 1 , 2, 33, 34, 50, 52, 54, or 63, further comprising a stent.

76. The system of claim 1 , 2, 33, 34, 50, 52, 54, or 63, further comprising a delivery catheter.

77. The system of claim 1 , 2, 33, 34, 50, 52, 54, or 63, further comprising an introducer sheath.