AU2006203686B2 - Endoluminal devices, embolic filters, methods of manufacture and use - Google Patents

Description

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AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Applicant: GORE ENTERPRISE HOLDINGS, INC.

Invention Title: ENDOLUMINAL DEVICES, EMBOLIC FILTERS, METHODS OF MANUFACTURE AND USE The following statement is a full description of this invention, including the best method of performing it known to me/us: SENDOLUMINAL DEVICES. EMBOLIC FILTERS. METHODS OF W MANUFACTURE AND USE FIELD OF THE INVENTION: The present invention relates to seamless endoluminal devices including frame patterns for filters, their manufacture and use in the filtration and/or removal of embolic

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00 matter from fluids flowing in tubular body lumens including, but not limited to: blood flow in

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Sarteries and veins; airflow within the respiratory tract; and the flow of urine in the urinary Stract. The seamless filter of the present invention may be self-expanding, Is deployable via a N guidewire-based system and has a low profile.

BACKGROUND OF THE INVENTION: Embolic protection is a concept of growing clinical Importance directed at reducing the risk of embolic complications associated with interventional transcatheter) and surgical procedures. In therapeutic vascular procedures, liberation of embolic debris thrombus, clot, atheromatous plaque, etc.) can obstruct perfusion of the downstream vasculature, resulting in cellular ischemia and/or death. The therapeutic vascular procedures most commonly associated with adverse embolic complications Include: carotid angioplasty with or without adjunctive stent placement and revascularization of degenerated saphenous vein grafts. Additionally, percutaneous transluminal coronary angioplasty (PTCA) with or without adjunctive stent placement, surgical coronary artery by-pass grafting, percutaneous renal artery revascularization, and endovascular aortic aneurysm repair have also been associated with complications attributable to atheromatous embolization. Intraoperative capture and removal of embolic debris, consequently, may improve patient outcomes by reducing the incidence of embolic complications.

The treatment of stenoses of the carotid bifurcation provides a good example of the emerging role of adjuvant embolic protection. Cerebrovascular stroke is a principle source of disability among adults, and is typically associated with stenoses of the carotid bifurcation.

The current incidence of cerebrovascular stroke in Europe and the United States is about 200 per 100,000 population per annum (Bamford, Oxfordshire community stroke project.

Incidence of stroke in Oxfordshire. First year's experience of a community stroke register.

BMJ 287: 713-717, 1983; Robins, The national survey of stroke: the National Institute of Neurological and Communicative Disorders and Stroke. Office of Biometry and Field Studies Report. Chapter 4. Incidence. Stroke 12 (Suppl. 1-57, 1981). Approximately half of the patients suffering ischemic stroke have carotid artery stenoses (Hankey, Investigation and imaging strategies in acute stroke and TIAs. Hospital Update 107- 124, C\Z 1992). Controlled studies have shown that the surgical procedure carotid endarterectomy tb (CEA) can reduce the incidence of stroke in patients compared to medical therapy with minimal perioperative complications for symptomatic patients with stenoses [NASCET, Beneficial effect of carotid endarterectomy in symptomatic patients with high grade stenoses. NEJM 325: 445 453, 1991] and for asymptomatic patients with stenoses [ACAS, Endarterectomy for asymptomatic carotid artery stenosis. JAMA 273: 00 1321-1461, 1995]). These results provide convincing evidence of the benefit of treating t' carotid stenoses. Surgery, however, does have several limitations, including: increased

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Smortality in patients with significant coronary disease restriction to the cervical portion Sof the extra-cranial vasculature, a predeliction for cranial palsies and restenosis Yadav, Elective stenting of the extracranial carotid arteries. Circulation 95: 376- 381, 1997).

Carotid angioplasty and stenting have been advocated as potential alternatives to CEA. Percutaneous techniques have the potential to be less traumatic, less expensive, viable in the non-cervical extracranial vasculature, and amenable to patients whom might otherwise be inoperable (Yadav, Elective stenting of the extracranial carotid arteries.

Circulation 95: 376-381, 1997). Despite the potential benefits of this approach, emboli liberated during trans-catheter carotid intervention can place the patient at risk of stroke.

Emboli can be generated during initial accessing of the lesion, balloon pre-dilatation of the stenosis, and/or during stent deployment. Additionally, prolapse of atheromatous material through the interstices of the stent can embolize after the completion of the procedure.

The fear of dislodging an embolus from an atherosclerotic plaque has tempered the application of angioplasty and endovascular stenting to the supraaortic arteries and, particularly, to the carotid bifurcation (Theron, New triple coaxial catheter system for carotid angioplasty with cerebral protection. AJNR 11: 869-874, 1990). This concern is warranted due to the significant morbidity and/or mortality that such an event might produce. While the incidence of stroke may be at an acceptable level for the highly skilled practitioner, it is likely to Increase as the procedure is performed by less experienced clinicians.

Embolic protection devices typically act as an intervening barrier between the source of the clot or plaque and the downstream vasculature. In order to address the issue of distal embolization, numerous apparatus have been developed and numerous methods of embolic protection have been used adjunctively with percutaneous interventional procedures. These techniques, although varied, have a number of desirable features including: intraluminal delivery, flexibility, trackabllty, small delivery profile to allow crossing of stenotic lesions, dimensional compatibility with conventional interventional implements, ability to minimize flow perturbations, thromboresistance, conformability of the barrier to the entire luminal N cross-section (even if irregular), and a means of safely removing the embolic filter and t trapped particulates.

;For example, occlusion balloon techniques have been taught by the prior art and involve devices in which blood flow to the vasculature distal to the lesion is blocked by the inflation of an occlusive balloon positioned downstream to the site of intervention. Following therapy, the intraluminal compartment between the lesion site and the occlusion balloon is oO aspirated to evacuate any thrombus or atheromatous debris that may have been liberated INDduring the interventional procedure. These techniques are described in Theron, New triple 0 coaxial catheter system for carotid angloplasty with cerebral protection. AJNR 11: 869-874, ID1990, and Theron, Carotid artery stenosis: Treatment with protected balloon angioplasty and stent placement. Radiology 201: 627-636, 1996, and are commercially embodied in the PercuSurge Guardwire PlusT Temporary Occlusion and Aspiration System (Medtronic AVE). The principle drawback of occlusion balloon techniques stem from the fact that during actuation distal blood flow is completely inhibited, which can result in ischemic pain, distal stasis/thrombosis, and difficulties with fluoroscopic visualization due to contrast wash-out through the treated vascular segment.

Another prior system combines a therapeutic catheter angloplasty balloon) and integral distal embolic filter. By incorporating a porous filter or embolus barrier at the distal end of a catheter, such as an angioplasty balloon catheter, particulates dislodged during an interventional procedure can be trapped and removed by the same therapeutic device responsible for the embolization. One known device includes a collapsible filter device positioned distal to a dilating balloon on the end of the balloon catheter. The filter comprises a plurality of resilient ribs secured to the circumference of the catheter that extend axially toward the dilating balloon. Filter material is secured to and between the ribs. The filter deploys as a filter balloon is inflated to form a cup-shaped trap. The filter, however, does not necessarily seal around the interior vessel wall. Thus, particles can pass between the filter and the vessel wall. The device also presents a large profile during positioning and is difficult to construct.

The prior art has also provided systems that combine a guidewire and an embolic filter. The filters are incorporated directly into the distal end of a guldewire system for intravascular blood filtration. Given the current trends in both surgical and interventional practice, these devices are potentially the most versatile in their potential applications.

These systems are typified by a filter frame that is attached to a guidewire that mechanically supports a porous filter element. The filter frame may include radially oriented struts, one or more circular hoops, or a pre-shaped basket configuration that deploys in the vessel. The filter element typically includes a polymeric mesh net, which is attached in whole or In part to the filter frame and/or guidewire. In operation, blood flowing through the vessel is forced tb3 through the mesh filter element thereby capturing embolic material in the filter.

Early devices of this type include a removable intravascular filter mounted on a hollow guidewire for entrapping and retaining emboli. The filter is deployable by manipulation of an actuating wire that extends from the filter into and through the hollow tube and out the proximal end. During positioning within a vessel, the filter material is not fully 00 constrained so that, as the device is positioned through and past a clot, the filter material can

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potentidlly snag clot material creating freely floating emboli, prior to deployment.

SIn another prior art system an emboli capture device is mounted on the distal end of IC a guidewire. The filter material is coupled to a distal portion of the guidewire and is Sexpanded across the lumen of a vessel by a fluid activated expandable member in communication with a lumen running the length of the guidewire. During positioning, as the device Is passed through and beyond the clot, filter material may interact with the clot to produce emboli. This device may also be difficult to manufacture.

Another prior art device is adapted for deployment in a body vessel for collecting floating debris and emboli in a filter that includes a collapsible proximally tapered frame for operably supporting the filter between a collapsed insertion profile and an expanded deployment profile. The tapered collapsible frame includes a mouth that is sized to extend to the walls of the body vessel in the expanded deployed profile to seal the filter relative to the body vessel for collecting debris floating in the body vessel.

A further example of an embolic filter system involves a filter material fixed to cables or spines of a central guidewire. A movable core or fibers inside the guidewire can be utilized to transition the cables or spines from approximately parallel to the guidewire to approximately perpendicular to the guidewire. The filter, however, may not seal around the interior vessel wall. Thus, particles can pass between the filter and the entire vessel wall.

This umbrella-type device is shallow when deployed so that, as it is being closed for removal, particles have the potential to escape.

Other disadvantages associated with the predicate devices are that the steerability of the guidewire may be altered as compared to the conventional guidewires due to the presence and size of the filter. The guidewire, for example, may bend, kink, and/or loop around in the vessel, making insertion of the filter through a complex vascular lesion difficult.

Also, delivery of such devices in a low-profile pre-deployment configuration can be difficult.

Further, some devices Include complex and cumbersome actuation mechanisms. Also, retrieving such capture devices after they have captured emboli may be difficult. Further, when deployed in curved segments, the Interaction of the guldewire and/or tether elements can deform the filter frame in such a way as to limit apposition to the host vessel wall, thereby allowing potential chanhels for passage of embolic debris. Also, the filter media of F-A the prior art maintains a pore diameter of approximately 80 to 120 microns. It is tbdesirable to minimize the pore size without adversely perturbing blood flow or being prone to clogging.

Current filter designs suffer from numerous disadvantages due to their construction. A typical wire filter is formed by manipulating multiple wires together through welding or some other form of attachment. After the wire frame is constructed, 00 it is formed into the desired shape and a filter element is affixed onto the wire cage. A IND typical wire frame constructed in this manner is subject to a limited range of manipulation after the wires are adhered, since the welds or attachment areas are at an O 10 increased risk of failure due to the physical constraints of the welds themselves. A wire Spair is more inclined to fracture at the weakest point, typically, a wire frame, composed of numerous wire pairs, will separate at the weld before separating in the length of the wire. Additionally, the welding of metal involves the application of increased heat to join a wire pair and a risk exists of the mesh, formed by the pairs, dripping or otherwise malforming due to the proclivity of metal to run before cooling.

A further disadvantage to a typical wire filter is that the filter element is difficult to apply to the frame since the filter is normally applied as a sock, tube, or other such shape. The typical wire frame is formed by welding and bending into the desired shape.

The filter is then affixed onto the shaped wire frame by pulling the formed filter over the shaped wire frame. An additional problem evident in this construction is that the filter element could be abraded by a protrusion formed by a weld in a wire pair. Such an abrasion could form a weakness or a tear in the filter and undermine its desired functionality.

Simple and safe blood filtering and guidewire systems that can be temporarily placed in the vasculature to prevent distal embolization during endovascular procedures, and that can be used to introduce and/or exchange various instruments to a region of interest without compromising the position of the filter or guidewire, are required. Existing guidewire-based embolic filtering devices are inadequate for these and other purposes. The present apparatus, in contrast, provides a novel means of providing these and other functions, and has the further benefit of being easier to manufacture than the devices of the prior art.

SUMMARY OF THE INVENTION: The present invention relates to a method of constructing a uni-body, selfexpanding filter frame comprising: extracting a substantially two-dimensional filter frame pattern from common H:\melindaf\keep\Speci'8\P61864.doc 21/08/06 (planar sheet of precursor material by cutting; Sconfiguring said two-dimensional pattern into a three-dimensional Z configuration; and thermally annealing said three-dimensional configuration.

One aspect of the present invention is to provide a method of attaching a biocompatible, permeable filter media to a three-dimensional filter frame comprising:

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00 providing a three-dimensional filter frame; INO deforming the three-dimensional frame into a substantially planar, two O dimensional configuration; and O 10 adhering at least one layer of filter media on the frame.

SAnother aspect of the present invention is to provide a method of assembling a filter comprising: providing a conical filter element; providing a three-dimensional seamless filter frame; and laminating said filter element and frame together.

A further aspect of the present invention is to provide a method of constructing a uni-body, frame comprising: extracting a substantially two-dimensional plastically deformable frame pattern from a common planar sheet of plastically deformable material by cutting; configuring said two-dimensional pattern into a three-dimensional configuration; and thermally treating said three-dimensional configuration.

A still further aspect of the present invention is to provide a method of constructing a uni-body, self-expanding frame comprising: extracting a substantially two-dimensional frame pattern from a common planar sheet of a shape-memory alloy, self-expanding material by cutting; configuring said two-dimensional pattern into a three-dimensional configuration; and thermally annealing said three-dimensional configuration.

BRIEF DESCRIPTION OF THE DRAWINGS: Figures 1 A, 1B and 1C illustrate the steps of constructing a first twodimensional frame, whereas Figures 1D and 1 E illustrate a resulting three-dimensional shape with a filter media attached thereto.

Figures 2A, 2B and 2C respectively illustrates an alternate configuration of a two-dimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

H:\melindaf\keep\speci'S\P61864.doc 21/08/06 -7- Figures 3A, 3B and 3C respectively illustrate an alternate configuration of a Stwo-dimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

Figures 4A, 4B and 4C respectively illustrate an alternate configuration of a two-dimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

oO Figures 5A, 5B and 5C respectively illustrate an alternate configuration of a IN, two-dimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

,O 10 Figures 6A, 6B and 6C respectively illustrate an alternate configuration of a two-dimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

Figure 7A, 7B and 7C respectively illustrate an alternate configuration of a twodimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

Figure 7D illustrates an annealed frame pattern having articulation segments in the attachment struts and Figure 7E illustrates a frame pattern having longitudinally spaced support members interconnected by articulation segments.

H:\melindaf\keep\Speci s\P61864.doc 21/08/06 NFigures 8A, 8B and 8C respectively illustrate an alternate configuration of a twot dimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

Figures 9A, 9B and 9C respectively illustrate an alternate configuration of a twodimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

oO Figures 10A, 10B and 1OC respectively illustrate an alternate configuration of a two- IND dimensional frame, a resulting three-dimensional shape after annealing and a depiction of 0 the frame with an integral filter media.

DFigures 11A, 11B and 11C respectively illustrate an altemrnate configuration of a two- Sdimensional frame, a resulting three-dimensional shape after annealing and a depiction of the frame with a filter media attached.

Figures 12A, 12B, 12C, 12D and 12E respectively Illustrate alternate apex and strut configurations adapted to accept and house radio-opaque markers.

Figure 13 illustrates a three-dimensional frame with an attached filter media positioned between a guidewire and an atraumatic tip.

Figures 14A and 14B depict the filtering apparatus as deployed within a vessel having tortuous anatomy.

Figure 15 illustrates an alternate system for assembling an alternate embolic filter configuration.

Figure 16 illustrates a system for assembling a filter-in-filter device.

Figure 17 illustrates the filter-in-filter assembled using the system of Figure 16.

Figures 18A, 18B and 18C respectively illustrate a tooling device, a two-dimensional frame being formed into a three-dimensional configuration, and the tooling device supporting the three-dimensional frame for annealing.

Figures 19A, 19 B and 19C respectively illustrate the steps for converting a conical filter into "sombrero" shaped filter configuration.

Figure 19D Illustrates a three-dimensional frame supporting a "sombrero" shaped filter media.

Figures 19 E and 19F depict an alternative filter sack configuration in which the sack resembles an asymmetric cone.

Figures 20A, 20B and 20C respectively illustrate a filter-in-filter configuration with a pharmacological agent loaded in the space between the filter media, an alternate filter configuration with the filter media pre-loaded with the pharmacological agent, and the elution of the pharmacological agent in a lumen/vessel of a host.

Figures 21A and 21B respectively illustrate deployment of an occluder device in a lumen/vessel of a host and the detachment of the ocdcluder.

Figures 22A and 22B respectively illustrate the deployment of an obstruction tremover and collection of removed lesion debris in a lumen/vessel of a host.

Z Figures 23A, 23B and 23C illustrate the use of an anchoring device for treatment of a lesion in tortuous vessels associated with renal anatomy.

Figures 24A, 24B 24C, 24D and 24E respectively illustrate a two dimensional frame, a three-dimensional resulting shape, an endovascular device formed from the three- IO dimensional frame and an open-ended windsock, the occlusion of a sacular aneurysm in a IND host lumen/vessel with the endovascular device and optional use of a stent lining the device.

SFigure 25A illustrates a delivery catheter having a guidewire lumen and guidewire IDsupported filter.

Figures 25B, 25C, 25D and 25E respectively illustrate views of alternate distal catheter delivery tips.

Figures 25F, 25G and 25H respectively illustrate three-dimensional top views of catheter tube having a channel indented in its surface adjacent Its distal end, a sleeve covering the indented channel and a guidewire located in the sleeve covered-indented channel.

Figures 26A, 26B, 26C 26D and 26E respectively illustrate steps followed in treating a lesion In a host lumen/vessel.

Figures 27A, 27B and 27C respectively illustrate a view of the distal tip a delivery catheter with an alternate auxiliary lumen configuration, a three-dimensional top view of the auxiliary lumen configuration and an auxiliary lumen mounted guidewlre.

Figure 28 illustrates a configuration of the present invention deployed as an implantable vena cava filter.

Figures 29A and 29B respectively illustrate an alternate two-dimensional planar configuration of the present invention, and a three-quarter isometric view of this configuration formed into a three-dimensional shape designed for use as an implantable stent.

Figure 30 is a flat pattern view of a filter frame and integral tether elements as would be cut from a tube.

Figure 31 is a flat pattern view of a filter frame and integral tether elements after being formed and annealed at a functional size.

Figures 32A, 32B, 32C, 32D and 32E respectively show variations in the tether geometry, designed to allow the tethers to articulate with respect to one another and to the filter frame itself.

SDETAILED DESCRIPTION OF THE INVENTION: SAs used herein the following terms are defined as followed: The term "proximal" is defined as the location closest to the catheter hub and "distal" is the location most distant from the catheter hub. With respect to the inventive threedimensional uni-body frame, the term "proximal" is the frame end attached to the guidewire or the frame side through which debris enters to be collected by an associated filter.

00oO The term "uni-body" refers to a frame pattern formed from a single piece of material

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and therefore considered "seamless." Terms such as unitary, integral, one-piece' are synonymous with "uni-body" and also Irefer to a frame pattern that is formed from a single or common piece of material.

SFilament, wire or ribbon are alternate terms used to describe the portions/sections of pattern material that remain after etching a planar precursor frame material and form the attachment struts, the support struts, the filter/filter support struts that extend in the longitudinal, circumferential, or any other direction necessary to define a frame pattern.

Figures 1A -1D schematically show the four method steps that are followed to manufacture a uni-body, self-expanding filter device in accordance with the present invention. Figure 1A shows a fiat sheet material 110, preferably a shape memory alloy material, a NiTi alloy, Nitinol, or any other suitable bioacceptable material, such as a metal, stainless steel, or bioacceptable polymer. The flat sheet material 110 is used to form the "uni-body" frame pattern 115 of Figure IC, or other frame patterns described hereinafter.

A desired pattern is formed on sheet material 110, as in the case of Figure 1B, which shows a radially symmetric filter frame pattern having six "pie" shaped wedges 120. The wedges 120 are removed by etching In a chemical photo-etching process, or any other suitable technique, to form a frame defined by filament sized material. The frame pattern can also be obtained by using a laser or any other cutting procedure or process capable of precisely etching, stamping, or otherwise cutting the flat sheet 110 into the preferred shape.

Radial sides 125, 130 and arcuate side 135 circumscribe the wedges 120. Slits 145 are formed and center section 150 is removed by any suitable cutting technique. After the slits 145 are formed, and wedges 120 and center section 150 removed, flashing 140 is removed (such as by trimming with fine scissors or diagonal cutters), leaving the desired skeletal two-dimensional filter frame/pattern 115, shown in Figure 1C.

Skeletal frame 115 includes attachment struts 155 with proximal ends 165 that are to be fixed or attached to proximal connecting member 170 of Figure 1 D, adapted to cooperate with a guidewire (not shown). Attachment struts 155 extend seamlessly from support struts 156 because they are formed from the same precursor material. Support struts 156 are seamlessly connected to or seamlessly interconnected with one another.

i Seamlessly interconnected support struts 156 define a boundary, perimeter or cell having tb the configuration of a six-pointed "star." When frame 115 is converted into a threedimensional configuration, the seamlessly associated/interconnected struts 156 typically form a "closed" support member 156A that circumscribes the longitudinal axis of the threedimensional frame, thereby providing a radial or transverse dimension to the threedimensional frame. The boundary, perimeter, cell or support member 156A can be any 00 00 geometric configuration so long as it provides a radial dimension (transverse to the t' longitudinal axis) for the frame. The support member circumscribes the longitudinal axis of Cr the frame and may also be described as being ring-shaped. In addition to providing the Iframe with a radial dimension, as shown in Figure I D, the support member 156A is typically Sthe location for attaching the proximal open end 161 of the filter 160. Thus the support member also functions to maintain the proximal end of filter media 160 in the open operative configuration. Filter media 160 may be formed from any suitable material, and also includes a closed distal end 162.

The planar, two-dimensional frame pattern of Figure lC is then annealed, normally by thermal annealing, Into a three-dimensional configuration. The three-dimensional annealed frame configuration 175, may be further processed, as described hereinafter, to include a filter media resulting in filter 100 which Includes the frame 175 and filter media 160, as in Figures ID and 1E. For ease of consistency and brevity throughout the remainder of the application and without relinquishing equivalents thereof, Nitinol is used as the filter frame material in each and every embodiment shown and described hereinafter. However, as discussed above, other suitable materials, such as, titanium nickel alloys, shape memory materials, blocompatible metals, stainless steel, or plastic may be used for the uni-body filter frame.

Figures 2A 2C through 11A- 110 C depict altemrnate filter frame patterns that can be formed following the procedures described with reference to Figures IA-1E. As a result, the various struts are seamlessly interconnected since they are formed from the same precursor material.

Figure 2A illustrates a plan view of an alternate frame pattern 215 having hoop shaped struts 256 connected to attachment struts 255. Figure 2B illustrates the three dimensional filter frame 275 after annealing with proximal ends of the attachment struts 255 fixed to the proximal connecting member 270 and struts 256 seamlessly connected to one another and forming a closed support member 256A. As with Figure 1C, struts 255 seamlessly extend from support member 256A. Figure 2C illustrates a filter 200 attached to a guldewire 280. The filter 200 includes the three-dimensional frame 275 with a filter media 260 having a "butterfly" configuration. .The configuration of filter media 260 can also be described as substantially parabolic..

N Figure 3A Illustrates an alternate two-dimensional (plan view) frame pattern 315 tbL having attachment struts 355, attachment strut proximal ends 365, filter struts 385 which ;Z may also support optional filter media 360 of Figure 3D. Filter pattern 315 also includes support struts 356. Support struts 356 and filter struts 385, which are seamlessly associated with one another, cooperate to define cell 357, which is configured In the shape of a IND diamond. Struts 355, 356 and 385 are seamlessly associated with one another since they 00 are formed from the same precursor material. Struts 356 define a boundary around six cells 357 and form a closed support member 356A for maintaining the three-dimensional filter of Figure 3C in an open, operative configuration. Figure 3B illustrates three-dimensional IND frame 375 that is obtained after the two dimensional filter frame pattern is annealed, with the proximal ends 365 of the attachment struts 355 fixed to proximal connecting member 370.

In the embodiment of Figure 313, the filter struts 385 allow the device to be used as a filter, without the filter media shown in Figure 3C. While the filter pattern of Figure 3B shows six filter struts 385, any number of filter struts or support struts can be used, including, but not limited to 4, 5, 7, 8, 9, 10, 11, 12, etc. In addition, although Figure 3A depicts the filter frame 315 with diamond shaped cells/openings 357, cells 357 can be of any geometrical shape or size, so long as the openings are of sufficient size to permit blood flow and/or filtering.

Figure 3C illustrates the annealed filter frame pattern of Figure 3B with filter media 360 attached to a guidewire 380.

Figure 4A Illustrates a two-dimensional alternate seamless frame pattern 415 having attachment struts 455, support struts 456, and filter/filter media support struts 485. The pattern is seamless because it Is formed from the same precursor material. Figures 4B and 4C illustrate three-dimensional views of filter frame pattern 475 after annealing, with the proximal ends of the attachment struts 455 fixed to the proximal connecting member 470, support struts 456 forming support member 456A, and filter media support struts 485 extending in a distal direction. Figure 40 illustrates the annealed filter frame pattern 475 of Figure 4B with filter media 460 attached to a guldewire 480.

Figure 5A illustrates the two-dimensional alternate seamless filter pattern 515 having attachment struts 555, support struts 556, filter media support members 590, and filter support struts 585. The pattern is seamless because It is formed from the same precursor material. Figures SB and SC illustrate three-dimensional views of the filter frame pattern 515 of Figure 5A after annealing, frame 575, with proximal ends of the attachment struts 555 fixed to the connecting member 570, support struts 556 of Figure 5A form closed support member 556A, and filter media support struts 585 extend distally away from the proximal connector 570. Figure 5C Illustrates the annealed filter frame pattern 575 of Figure 5B with filter media 560 attached to a guidewire 580.

Figure 6A illustrates the two-dimensional alternate seamless filter pattern 615 having attachment struts 655, support struts 656 and filter support struts 685. The pattern Is seamless because it is formed from the same precursor material. Figures 6B and 6C illustrate three-dimensional views of filter frame pattern 615 of Figure 6A after annealing, with the proximal ends of the attachment struts 655 fixed to the connecting member 670, Isupport struts 656 of Figure 6A forming support member 656A and filter media support 00 struts 685. Figure 6C illustrates the annealed filter frame pattern 675 of Figure 6B with filter Smedia 660 attached to a guidewire 680.

SFigure 7A illustrates a two-dimensional view of a seamless alternate filter pattern I715 having attachment struts 755 and support member struts 756. The pattern is seamless Sbecause it is formed from the same precursor material, for supporting the open end of filter media 760 of Figure 7C. Figures 7B and 7C illustrate side views of the three-dimensional filter frame 775, after annealing, with the proximal ends of the attachment struts 755 fixed to the connecting member 770 and support struts 756 of Figure7A forming support member 756A. Figure 7C illustrates the annealed filter frame pattemrn of Figure 7B with filter media 760 attached to a guidewire 780. Figure 7D illustrates the annealed frame pattern having articulation segments 790 in the attachment struts 755. Figure 7E illustrates an alternate design, wherein there are two longitudinally spaced support members 756A seamlessly interconnected to one another by articulation segments 790, described in greater detail hereinafter.

Figure 8A illustrates a two-dimensional view of an alternate spirally configured filter pattern 815. Figures 8B and 8C illustrate three-dimensional views of the filter frame pattern 815 of Figure 8A after annealing, frame 875, with a proximal end of the frame 875 fixed to the connecting member 870. Figure 8C illustrates the annealed filter frame pattern of Figure 8B with filter media 860 attached to a guidewire 880. In the filter frame illustrated in Figure 8B, one of the turns of the spirally shaped frame, which is not "closed," forms the support member that provides radial dimension to the frame.

Figure 9A illustrates a two-dimensional view of an alternate seamless filter pattern 915 having attachment struts 955 and filter media support struts 985. The pattern is seamless because it is formed from the same precursor material. Figures 9B and 9C illustrate three-dimensional views of the filter frame pattemrn after annealing, frame 975, with the proximal ends of the attachment struts 955 fixed to the proximal connecting member 970. In this embodiment the filter media support struts 985 closest to the proximal connector also function as the closed support member described herein to provide the transverse dimension of the frame and support the proximal end of the filter 960. Figure 9C illustrates the annealed filter frame pattemrn 975 of Figure 9B and filter media 960 attached to a guidewlre 980.

NFigure 10A illustrates a two-dimensional view of an alternate seamless filter pattern 1015 having attachment struts 1055 and a central portion of the planar Nitinol precursor material 1010 rendered porous 1090. Figures 10B and 10C illustrate three-dimensional views of the filter frame pattern 1015 of Figure 10A after annealing, frame 1075, with the proximal ends of the attachment struts 1055 fixed to the connecting member 1070, and the porous precursor material 1090 having pleats 1095. Figure 10C illustrates the annealed 00oO filter frame pattern 1075 of Figure 10B attached to a guldewire 1080. A separate filter

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media is not necessary in the embodiment illustrated in Figures IOA- 10 because the Sporous precursor portion 1090 serves as the filter media.

IFigure 11A illustrates a two-dimensional view of an alternate seamless filter pattern S1115 having attachment and filter strut 1156 which will also function as the closed support member 1156A shown in Figure 11B. Figures 11B and 11C illustrate three-dimensional views of the filter frame pattern 1115 of Figure 11A after annealing, frame 1175, with the proximal end of the closed support member 1156A fixed to the connecting member 1170.

Figure 1 C illustrates the annealed filter frame pattern 1175 of Figure 11 B with filter media 1160 attached to a guidewire 1180.

Although the above embodiments show a single support member 156A, 256A, 356A, 456A, 556A, 656A, 756A, 956A, etc., it is clearly within the scope of the invention to have a plurality of longitudinally spaced support members, members that circumscribe the longitudinal axis of the frame, that are seamlessly interconnected with one another via struts or articulation segments, as in Figure 7E. Similarly other embodiments described hereinafter may also include a plurality of seamlessly interconnected support members where the mechanism for interconnection includes struts, and/or the articulation segments which are defined hereinafter. In addition, when there are more than two support members connected to one another, some or all may be interconnected with struts and some or all may be interconnected via articulation segments. Thus, there could be a series of two, three, four or more members, and in the case with at least three support members that circumscribe the pattern's longitudinal axis, both struts and articulation segments can be used in an alternating pattern.

Figures 12A, 12B, 12C, 12D and 12E illustrate alternate configurations of stent strut, and apex designs which allow for, accept and house ancillary components. Figure 12A depicts a housing 1210, which could be machined, stamped, lasered or etched into the stent frame. Housing 1210 Is then filled with a material 1250 such as gold or platinum-iridium (to provide enhanced radio-opacity) or with a therapeutic agent such as a drug (to provide a prescribed biological response). Figure 12B depicts housing 1210 located along the side of a strut. Figure 12C depicts multiple housings 1210 along a strut. Figure 12D depicts multiple housings 1210 located within the strut periphery. Figure 12E depicts an alternate Sshape (arrowhead) housing 1210 (to be used as a radlopaque marker housing) located within the strut periphery. It should be noted that multiple shapes and sizes of housings could be configured. The radiopaque markers could be located In any strut or support member of the frame of the filter or the stent. Advantages of the application of radio-opaque markers in the fashions shown are: 1) stent cross section thickness is not increased (lending to reduction in introductory device profiles), 2) allows for precise and uniform spacing of 00 markers, and 3) allows for a multitude of shapes (dots, arrows and other characters such as Mc, letters or words) to be easily incorporated Into the frame. The housings may also provide a 0 N cavity In which to Insert and/or attach onboard electronics or sensors.

IFigure 13 illustrates an embolic filter assembly system 1300 that includes three Sfunctionally distinct regions. Section 1300A includes a support wire that terminates at its dlstal end In connecting member 1370. -The support wire may be the guidewire 1380 used to deliver a therapeutic device, a deployment catheter or angioplasty balloon. Section 1300B is any one of the embolic filter devices described in Figures 1A-1 E through 1 1A-1 C described herein, or another other device described hereinafter. Section 1300C may Include an atraumatic tip 1396 or other suitable tip known to those skilled in the art having a proximal end fixed/attached/cooperating with distal connecting member.

Figure 14A depicts the filter apparatus 1400 as deployed in a vessel 1420 with tortuous anatomy. As shown, such a condition results in a non-linear apparatus deployment configuration. In order for filter frame 1410 to maintain sufficient vessel wall apposition (which eliminates peri-device channel formations), the tether elements 1430 must be capable of deforming and/or articulating.

Figure 14B depicts the filter apparatus 1400 as deployed at a different site within the same vessel 1420 anatomy of Figure 14A, once again demonstrating the flexibility required of the deflecting and articulating tether elements 1430. It Is clear In this depiction that the guidewire 1440 does not necessarily follow the host vessel centerline. This phenomenon, coupled with anatomical variances and the requirement of complete vessel wall apposition of the filter frame 1410 makes the inclusion of articulating tether elements 1430 a benefit and necessity for safe and confident embollc protection of downstream vasculature.

Figure 15 illustrates an arrangement to attach a filter media to any of the annealed filter frames described herein. The frame 1515, is sandwiched between filter media portions 1560A and 1560B, which are respectively sandwiched between cushion elements 1500C and 1500D, which layered assembly is located between heated top plate 1500A and heated base plate 1500B. Thus, resulting three-dimensional lamination of Figure 15 has a crosssectional view that is substantially conical. Application of heat and pressure, via heated platens 1500A and 1500B, result in the integral bonding of the filter media 1560A and 1560B, and the interposed frame 1515. The filter frame configuration via the lamination Sprocedure depicted in Figure 15 results in a filter assembly configuration resembling a S "butterfly net." Figure 16 schematically shows an altemrnate procedure for attaching filter media to an annealed filter frame. In Figure 16, an annealed filter frame 1615 is sandwiched between adjacent laminae of inner filter media 1660A and outer filter media 1660B. Heat and Ipressure are applied via upper and lower punch and die platens 1600A and 1600B. The 00 application of heat and pressure results in an integral bonding of the filter media 1660A and 1660B and interposed frame 1615. During the heating and pressure lamination process, a Svacuum may be applied in the lower platen 1600B thereby bonding the filter media and skeletal filter frame together. The filter media shown in Figure 16 is normally interposed only within the immediate vicinity of the filter frame 1615. Additionally, the application of the vacuum can be used to optimize the filter frame geometry. The method shown in Figure 16 can produce a filter frame configuration that resembles a butterfly net, such as the one shown in the device of Figures 7A-7C. This method can also be used to produce a framesupported "filter-in-filter," which is shown in further detail in Figure 17, described below.

Figure 17 shows an alternate embodiment of the present invention incorporating a two stage "filter-in-filter" design. The filter-in-filter design will provide improved filtration efficiencies, such as allowing each filter lamina to have a different porosity by using an inner filter media 1760A and an outer filter media 1760B. Alternatively, either filter media 1760A or 1760B can Incorporate an Integral Nitinol frame as one of the filter members.

Alternatively still, both the inner and outer filter media 1760A and 1760B could be an integral Nitinol filter frame. Use of an uni-body Nitinol frame, such as those described herein, would provide additional strudctural benefits in the completed filter frame apparatus.

Figures 18A, 18B, and 18C schematically illustrate an annealing method in which a planar, two-dimensional filter frame is converted into a three-dimensional configuration with the use of an appropriate flxturing/tooling device, a mandrel. Mandrel 1800A, shown in Figure 18A, is used to form the filter frame 1815 of Figure 18B into the desired shape.

After cutting a fiat metal sheet into the desired two dimensional configuration, such as that described above, the proximal ends 1865 of attachments struts 1855, the endpoints of the two-dimensional filter frame 1815, are collected at a point along the axis of radial symmetry as shown in Figure 18B. As depicted in Figure 18C, the filter frame 1815 is placed onto the fixturing device, which, in this case, is the mandrel 1800A of Figure 18A to impart a defined, three-dimensional configuration, and the frame 1815 of Figure 18B is annealed to preserve the desired configuration. After annealing, the three-dimensional filter frame 1875 can be elastically deformed into its original two-dimensional shape where a filter media can be applied according to any of the methods described and illustrated herein.

Following the attachment of the filter media, the three-dimensional filter configuration is readily obtained.

Figures 19A, 19B, 19C and 19D illustrate an alternate filter configuration using a "sombrero" shaped filter media 1960B with a supporting frame. To form the sombrero frame and filter shown in Figure 19D, a conical filter 1960, as shown in Figure 19A, has its closed distal end 1962 inverted toward the open proximal end 1961 of the conical filter 1960, to 00 form a convex, hat-like base as shown In Figure 19B. This inversion shortens the filter t' length, but retains the original area of the filter element 1960. Next, the convexity is Sincreased until the apex 1963 extends beyond the open end 1961, as shown in Figure 19C.

IThe filter 1960 thus has been shortened further, but the effective filter area still remains identical to the original conical filter area. The sombrero filter 1960B is attached to frame 1975, Figure 19D. The frame includes attachment struts that are fixed to a connecting member 1970, which in turn Is cooperatively associated with a guidewire 1955. Compared to conventional conical filter frame designs, the sombrero filter frame allows more surface area per unit length, or, altemrnatively, reduces filter length without compromising filter surface area and deflection of the trapped debris away from the vessel centerline. The desired sombrero filter frame configuration will also increase the reliable removal of entrapped debris.

Figures 19E and 19F depict an alternate filter sack configuration, also designed to collect and hold embolic debris away from the vessel centerline. In this case, an asymmetric cone shaped filter media sack 1990 is produced and attached to the filter frame 1960.

Collected emboli will tend to collect at the tip of the sack 1990 and are held offset in the vessel, thus allowing relatively unperturbed flow at the vessel centerline.

As shown in Figures 20A, 20B and 20C, a filter in accordance with the present invention can be used to deliver a pharmaceutical substance, anti-thrombotic agent, drug, etc., into the blood flow in a host lumen/vessel by deploying the filter in a lumen/vessel of interest. In Figure 20A, a filter device such as that described in Figure 17 above, can be loaded with a pharmacological agent in one or more different areas before delivery into the host. Thus, the drug can be loaded between layers of the filter media. The drug 2098 may be retained within the zone/space/area between the inner filter media 2060A and outer filter media 2060B ready to be delivered to the host.

Instead of using the filter-in-filter design of Figure 17, any of the other filter configurations described herein can be used by imbibing the drug into the filter media itself.

As shown in Figure 20B, the drug 2098 can be imbibed into the media 2060 itself.

Figure 20C illustrates drug administration in the host by deploying the drug delivering system of Figures 20A or 20B in a host lumen/vessel so that the blood flows through the filter media to elute the pharmacological agent, drugs. This method of localized drug 17 (Z delivery is effective for eluting a pharmacological agent contained either between adjacent Slayers of filter media or imbibed directly into the filter media. Fluid flow through the filter device of Figures 20A or 20B, or any other filter configuration described herein containing pharmacological agents provides a mechanism of mass transfer to downstream perfusion beds. The pharmacological agent could be pre-loaded into the filter or injected post deployment perhaps through an extension of the support/guidewire.

00 As shown in Figures 21A and 21B, occluding device 2175 can be formed as a

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detachable endoluminal filter frame that can be implanted in the host. The ocduding device 2175 thus implanted can either be permanently implanted or retrieved at a later point in time, Isuch as is required in vena cava filtering applications. As shown in Figure 21A, blood flow Sthrough the host can be obstructed by the implantation of the filter frame apparatus 2100.

The filter frame apparatus 2100, used as an indwelling or implantable occlusion device is shown in Figure 21A As shown in Figure 21B, a guidewire or support wire 2180 includes a distal end 2181 that may be detached from proximal connector 2170 that is connected to the occluding device 2175 or filter frame apparatus 2100. The support wire 2180 is used to position or remove occluding device 2175 or filter frame apparatus 2100 from a lumen in a host. The guidewire tip 2181 may be of any design for detachment from or reattachment to proximal connector 2170. Thus, the guidewire 2180 can have any capture capability, including screw threads, magnetic, ball-and-socket, male-female attachment, bayonet, or any type of coupling that will allow the guidewire 2180 to detach or reattach to the proximal connector 2170 for placement or movement therein.

Figures 22A and 22B illustrate the use of a filter (similar to the filtersl00 or 700, respectively shown in Figures 1D or 7C) to remove flow obstructions or to function as a thrombectomy device to remove intraluminal thrombus, for example. Figure 22A shows an obstruction at the lumen wall in a blood vessel of the host. Though commonly the lesion will have formed in a restrictive manner, the lesion is shown in a cross-sectional area with an upper and a lower component, that has narrowed the effective diameter of the lumen. Filter 2200 includes sharpened support members 2285 to enable the filter to be used as a type of scraper. The frame 2275 shown herein includes a filter media 2260 as a "catch bag." In Figure 22B, the filter 2200 is pulled with sharpened members 2285, effectively shearing the obstruction/lesion from the vessel wall of the host. As the lesion is sheared from the wall, sheared lesion parts are collected in the catch bag or filter media 2260. In this manner, the present filter frame can be used to remove lesions and collect the debris dislodged into the blood stream, to lessen the possibility of dotting downstream of the host vessel. This approach can likewise be used to capture and remove foreign objects from bodily passageways.

Figures 23A, 23B and 23C respectively illustrate the use of the inventive filter as an anchoring guidewire to facilitate the retention of a guidewire position in tortuous vessels of the renal circulatory system, and in particular for branch lumens offset at angles of approximately 900 Using the inventive filter frame as an anchor avoids or minimizes damage to the host vessel, and specifically avoids or minimizes damage to the endothelium of the host lumen/vessel. Figure 23A shows a lesion 2300A in a branch lumen/vessel 00 2300B assodciated with the renal anatomy of a host. In the non-limiting embodiment of

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M Figures 23A 23C, the branch lumen 23006 includes an approximate 900 turn toward the N existing anatomy shown. As illustrated In Figure 238 a filter frame 2375 is positioned and Ianchored in a renal circulatory vessel 2300B to fix the position of the support wire 2380. A Sslight pressure is imposed on the support wire 2380 and the approximate 900 turn is extended to more than 90* without dislodging or altering the position of the guidewire in relation to the host anatomy as shown in Figure 23B.

As shown in Figure 23C, a therapeutic catheter 2300C can be inserted over the support wire 2380 of the filter frame to perform the intervention. As a result, therapy devices can more easily negotiate a greater than 900 bend as shown in Figures 23B and 23C. Such therapy devices include, but are not limited to balloons, stents, etc. A further useful aspect of this embodiment is that, during Its use, a long "exchange length" guidewre is unnecessary. Since this device is capable of maintaining it's positioning after deployment, the necessity of "rapid exchange" or "monorail" catheters are obviated.

Figures 24A, 24B, 24C, 24D and 24E show a further embodiment of the present filter frame assembly, which is intended to function as an Implantable endoprosthesis 2476.

As shown in Figures 24A and 246, the initial seamless filter frame 2475 is formed from a loop-type frame 2415 from the same precursor material. In Figure 24C, the proximal end of an open-ended "windsock" shaped graft component 2477 is attached to the loop of the filter frame 2475 to form an endoprosthesis 2476. In Figure 24D, the loop-type frame 2475 with the attached open-ended windsock is deployed proximal to an aneurysmal defect, and the windsock shaped graft component 2477 extends downstream of the frame, effectively excluding the aneurysm 2400A Thus, frame and the opened ended sock function as an Implantable prosthetic vascular conduit where the filter frame 2475 functions as an anchoring stent, and the open-ended sock functions as a biocompatible liner. This device, shown in Figure 24E, may then be optionally lined with a stent 2480. This embodiment finds use as a stent and graft combination where the stent element would be deployed proximal to the intended therapy site and the graft element would be configured to be deployed by blood pressure.

Figures 25A-25H illustrate an exemplary delivery system for deploying the present filter frame 2575 or filter 2500 of the present invention. Figure 25A illustrates a frame 2575 19

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S or frame-filter 2500, such as frame 175 or frame-filter 100 of Figures 1D or 1E, frame 375 or frame-filter 300 of Figures 3B and 3C, or any of the other frame or frame filter assembly herein described, attached to a support or guidewire 2580 and positioned within a tubular delivery sheath 2500A of a delivery catheter. Figures 25B-25D illustrates front views taken from sectional plane A-A of Figure 25A, but without the frame 2575 or frame-filter 2500.

The section A-A1 (Figure 25B) illustrates a dual lumen extrusion catheter sheath. Section 00 A-A2 (Figure 25C) illustrates a single lumen extrusion having an additional covering formed Sfrom a shrink tube. Section A-A3 (Figure 25D) illustrates a second lumen adhered to the inner diameter of the tubular delivery sheath 2500A of Figure SFigure 25E 25H Illustrate the perspective detail of extemal guidewire 2580 loading Sof a catheter lumen. Figure 25E is a front view of the Figure 25G. Figure 25F illustrates the catheter having a longitudinally extending indented channel, which, as seen in Figure is circumscribed by a tubular section 2500C. The guidewire 2580 is inserted into the longitudinally extending channel 2500B between the external wall of the catheter and the tubular section 2500C. In use, a filter frame or filter-frame construct is pre-loaded into the distal end of the sheath adjacent to an exterior wire guide channel. The exterior wire guide is adapted to receive a guidewire in a rapid exchange configuration, however, unlike the prior art, the filter frame and guidewire 2580 are completely segregated and no aperture exists.

Figures 26A, 26B, 26C, 26D and 26E illustrate a method of using a filter frame assembly 2600 in accordance with the present invention. In Figure 26A, a lumen/vessel 2600A of the host has a lesion 2600B. A guidewire 2680 is deployed into the lumen/vessel 2600A past the target lesion 2600B. Thereafter, guidewire 2680 is back-loaded into the delivery system 2600C, such as the one described in Figures 25B-25D, 25F-25G, or Figure 27B. Then the delivery sheath 2600C is advanced across the target lesion 2600B. The delivery sheath 2600C is withdrawn, thereby allowing a self-expanding filter 2600 to deploy.

The self-expanding filter 2600 is normally designed to deploy spontaneously after the delivery sheath 2600C has been withdrawn in this manner. Thus, as shown in Figure 26C, the filter 2600 is deployed downstream of the lesion 2600B. A therapeutic catheter 2600D, such as an angioplasty balloon, is routed over the support wire 2680 in Figure 26D to treat target lesion 2600B. As also shown in Figure 26D, when the therapy is performed, the filter 2600 functions to capture any emboli dislodged or removed by the therapeutic catheter 2600D. Thereafter, as illustrated in Figure 26E, the filter 2600 is removed via insertion of a tubular capturing catheter 2600E over the support wire and retraction of the filter 2600 into the capture catheter 2600E Is performed. This retraction can be performed by pulling the filter 2600 partially back into the capture catheter lumen 2600E, effectively trapping the N emboli 2600F. In this manner, the lesion is dissipated through a therapeutic catheter without tb the result of any of the dislodged emboli or debris dislodging into the host.

Figures 27A, 27B and 27C illustrate a lumen 2710 having an auxiliary, internally positioned channel 2720 for receiving a guidewire 2730. Figure 27A illustrates the tip of the sheath having an internally located, peripherally positioned auxiliary channel 2720 formed by ID"pinching" the end of the tube wall as shown in Figure 27B. Figure 27C shows the 00 guldewire 2730 inserted through into the slit opening In the side of the catheter and exiting Mc, the tip.

N Figure 28 illustrates the use of the inventive filter 2800, as a vena cava filter. Since the inventive filters described herein may be readily detachable, the filter 2800 can be readily Sdetached from a deployment guidewire.

Figure 29A illustrates a planar two-dimensional seamless pattern, formed from metallic material, or any other suitable biocompatible material. Figure 29B illustrates a three-dimensional stent member formed from the planar two-dimensional pattemrn of Figure 29A, for use as an intraluminal stent. When extremely thin wall sections are required, such as in coronary stents, it is appropriate to fabricate the device from a planar sheet of material.

Planar material can be manufactured thinner than tubing due to the extra requirements of concentricity placed upon tubing stock. It should be noted that although only one design has been depicted, a wide variety of pattems and cell geometries may be produced from planar material. The various cell geometries are defined by the interconnected struts of the stent. In Figures 29A and 29B four interconnected struts 2910 define the four sided cell 2920. This planar material may be metallic or polymeric or a combination thereof, and in any case, may also be porous. Once the flat pattern is fabricated, it is formed into a 3-D shape (in the depicted instance, an open mesh tube). The formed stent may be either plastically deformable (and thus made from a malleable starting material) or may be self-expanding, in which case a super-elastic, pseudo-elastic or shape memory material may be used.

Subsequent processing such as thermal treatment, diametric reduction, de-burring and polishing may be incurred, depending upon the specific stent design. It should be understood that multiple 3-D stent "units" could be manufactured in such a way and attached together to form a much longer device.

Figure 30 depicts a view of a flat pattem of filter frame 3010 OA and integral tether element 3010B geometry as it would be cut from a tube. This tube may be made of a shape memory alloy such as Nitinol. Cutting could be accomplished by a variety of methods including machining, laser cutting, stamping or etching.

Figure 31 depicts the flat pattern geometry of Figure 30 subsequent to forming and annealing at a larger, functional size. Upon annealing, the filter frame 3010A resiliently Nmaintains this larger diametrical profile and the at least one tether element 3010B extends tb seamlessly from it.

;Figures 32A-32E depict alternate articulation segments formed as an integral part of the tether element thereby forming different tether element geometries, which allow articulation of the tether elements 3010B in relation to the filter frame 3010A Figure 32A depicts the tether element 3010B with an area of reduced strut width e.g. reduced crossoO sectional area, to allow increased flexibility. Figure 32B depicts tether element 3010B with IND several individual areas of reduced strut width to allow increased flexibility. Figure 32C O depicts tether element 3010B with a reduced width and formed "hinging" area to increase IDflexibility. Figure 32D depicts tether element 3010B with a reduced width and several Sformed "hinging" areas to increase flexibility. Figure 32E depicts tether element 3010B divided in two for a portion of its length. This division effectively increases the tether element flexibility so as to allow articulation. The articulation segment of the tether element, therefore, is configured to enhance the flexibility of the filter apparatus (and thus, conformance to the host vessel wall) as well as to minimize inadvertent trauma translated to the host vessel wall by movement or manipulation of the guidewire.

An articulation segment of the tether elements or struts is a desirable feature in that it allows adequate vessel wall apposition of the filter frame when the filter device is deployed in a curved segment of anatomy. In a curved segment, the tether element articulates and deflects to adjust for a non-linear deployment situation (See Figure 14). Thus, the filter frame itself can maintain an uncompromised and fully deployed condition. Likewise, because of its ability to attenuate longitudinal translation, the articulation segment provides a means of mitigating trauma of the host vessel wall due to guidewire manipulation. It should also be noted that the required deflection and articulation of the tether elements could be bought about by metallurgical means rather than, or in combination with, geometrical means.

For Instance, the tether 3010B and frame 3010A elements of Figures 32A-E, although seamless and integral, may be exposed to differeit thermal processing parameters (for example: through the use of fixturing to provide differential heat sink qualities), thus rendering the tether 301 OB ductile and pliable while the frame 3010 A maintains the stiffness required for adequate vessel wall apposition.

The articulation segments, though described with respect to the various frame patterns can be incorporated into any of the endovascular devices described herein. An articulation segment is a localized region that provides enhanced longitudinal flexibility. A localized region may have a cross-sectional area that Is the same as the remaining part a strut, but differs in geometry. Alternatively, the localized region could have the same geometry but a different cross-sectional area, or both the cross-sectional area and geometry Sof the localized region differ from the remaining part of the strut. An endovascular stent can have articulation segments In any of the interconnected struts of Figures 29A and 29B.

EXAMPLES OF THE PRESENT INVENTION: EXAMPLE 1: Nitinol Sheet Filter Frame and integral Tethers 00 A radially-symmetric geometrical pattern comprising interconnected struts forming

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closed polygonal shaped cells was chemically etched from a sheet of Nitinol (NiTI) to C produce a skeletal filter frame. The etching, preferably photoetching of Nitinol (Kemac ITechnologies, Irwindale, CA) is continued to achieve a desirable material thickness, to Soptimize the moment of inertia of the struts and to polish the surface finish.

This filter frame is then subjected to a thermal treatment to set the phase transition temperature of the NiTi to approximately 37 0 C by heating the filter frame to a temperature of about 450 0 C for about 10 minutes in an air convection oven (Carbolite Corporation, Sheffield, England followed by a rapid quench in ambient temperature water.

The NiTi filter frame was then laminated between two layers of an adhesivecoated porous polymer. The layers were positioned with the adhesive sides facing toward each other, and facing toward the NiTi. The adhesive was used to adhere the layers of film together as well as to the NiTi wire framework. A sacrificial porous polymer cushion material was used on each side of the device during this lamination procedure to provide compliance of the surface during compression. This compliance allows the earlier mentioned porous polymer membrane to conform to the wire shape. The composite sub-assembly which included cushion, porous polymer/adhesive laminate, NiTi, adhesive/porous polymer laminate, and cushion layers was then compressed in a SST fixture and heat treated at 320 0 C for 45 minutes in an air convection oven (Grieve Oven, The Grieve Corporation, Round Lake, IL).

Once the 'sandwiched' device was removed from the heat source and allowed to cool, the sacrificial cushion material was peeled away from each side of the device and the NiTI wires were disengaged from the fixture. A circular shape of approximately 0.625" in diameter was trimmed into the porous polymer using a 20-watt carbon dioxide laser. The remainder of porous polymer was trimmed from the wire frame by hand and discarded-.

Following the laser trimming operation (which can also be used to create the necessary pores in the filter media), the radially-oriented arms (struts) of the device were folded up and back on themselves to achieve a hollow, three dimensional, semi-conical shape. To maintain the device in this configuration, the Nm struts were inserted into a SST tube. This tube measured approximately 0.05" in length X 0.035" outer diameter X 0.025" inner diameter. This tube and indwelling NITi wires were then crimped to a 0.014" diameter 23 C\Z guidewire to provide a guidewire based endoluminal embolic protection device. The device W resembled a three dimensional "whisk" shape with a pleated porous polymer filter element attached to it.

The resulting pleats are designed to increase filter media surface area over the generally conical shapes found in the prior art. This increase in surface area also allows for a shorter filter length which enhances deliverability of the device by a) decreasing friction in 00 the delivery catheter and b) improving device overall flexibility.

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SEXAMPLE 2: Nitinol Tube Filter Frame.and Integral Tethers.

SA 1.3 mm Nitinol tube with a wall thickness of approx 0.1 mm (obtained from Nitinol SDevices and Components, Fremenot, CA) was laser cut (Laserage Technologies Inc, Waukegan, IL) to a single, undulating 6 apex ring geometry with integral tethers. This frame was then lightly grit blasted at 40 psi with 20 micron silicon carbide media in a grit blasting machine made by Comco Inc, Burbank, CA. The ring with integral tethers was then gently pushed up a tapered mandrel until it achieved a functional size of approx. 6mm. The ring, tethers and mandrel were then subjected to a thermal treatment to set the phase transition temperature of the NiTi to approximately 37 0 C in an air convection oven (Carbolite Corporation, Sheffield, England One skilled in the art will realize that variances in the geometry, metallurgy, thickness and heat treating of the filter frame can all be varied to create alternate embodiments with varying desirable properties. The ring and tethers (now at functional size) were then lightly coated with an fluorinated ethylene propylene (FEP) powder (FEP 5101 ,available from Dupont Corp, Wilmington, DE) by first stirring the powder in a kitchen blender (Hamilton Beach Blendmaster, Wal-Mart) after the power was mixed into a "cloud", the frame was hung into the blender for enough time for FEP to build up onto the surface of the ring. The frame, now coated with FEP powder was hung in an air convection oven (Grieve Oven, The Grieve Corporation, Round Lake, IL) set at 320 0 C for approx. one minute followed by air cooling to room temp.

The NiTi frame was then set atop a filter sack and attached though the application of localized heat (the heat causing the FEP coating on the ring to re-melt and flow onto the surface of the filter sack, thus providing a biocompatible thermoplastic adhesive). The tether lines were then routed through a gold tube (Johnson Matthey, San Diego, CA) radiopaque marker. The tethers were pulled until they began to apply tension to the frame. A guidewire was then Inserted into the gold band (from the opposite direction of the tether lines). The marker band was then crimped to secure the tethers and guidewire together. A small amount of instant adhesive (Loctite 401, Loctite Corp, Rocky Hill, CT) was applied to create a smooth transition from the guidewire to the OD of the gold band. One skilled in the art will 00

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realize that attachment of the filter to the guidewire could be accomplished by adhesion, Swelding, soldering, brazing, a combination of these, or a number of other methods.

O Upon drying, this embodiment of the endoluminal embolic filter is ready for testing.

Various illustrative examples of the invention have been described in detail. In addition, however, many modifications and changes can be made to these examples 0o without departing from the nature and spirit of the invention.

c In the claims which follow and in the preceding description of the invention, Sexcept where the context requires otherwise due to express language or necessary S o10 implication, the word "comprise" or variations such as "comprises" or "comprising" is Sused in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country.

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Claims (12)

1. 3. The method according to claim 1, wherein said pattern includes attachment struts, support struts and filter support struts.
2. 4. The method of claim 2, wherein the precursor material is a shape memory alloy. The method according to claim 1, wherein the two-dimensional filter frame has at least one closed cell, the at least one cell including an area that has a circumference defined by a seamlessly continuous ribbon or strut of the same precursor material.
3. 6. The method according to claim 1, further comprising attaching a filter media to the filter frame before or after annealing.
4. 7. The method according to claim 6, wherein the filter media includes a pharmacological agent.
5. 8. The method of claim 1, wherein a portion of said anneal frame is positioned between two layers or portions thereof of filter media and the layers assembly laminated together.
6. 9. A method of attaching a biocompatible, permeable filter media to a three- dimensional filter frame comprising: constructing a three-dimensional filter frame in accordance with the method of claim 1; deforming the three-dimensional frame into a substantially planar, two dimensional configuration; and N:\Melboume\Cases\Patent54000-54999P54436.AU.1\Speds\P54436.AU 1 Specfication 2008-10-13 doc 22/10/08 00 -27- O O adhering at least one layer of filter media on the frame. ¢,1 O 10. A method of assembling a filter comprising: C providing a conical filter element; constructing a three-dimensional filter frame in accordance with the method of claim 1; and oO laminating said filter element and frame together. IO
7. 11. A method of constructing a uni-body, frame comprising: O N 10 extracting a substantially two-dimensional plastically deformable frame pattern Sfrom a common planar sheet of plastically deformable material by cutting; configuring said two-dimensional pattern into a three-dimensional configuration; and thermally treating said three-dimensional configuration.
8. 12. A method of constructing a uni-body, self-expanding frame comprising: extracting a substantially two-dimensional frame pattern from a common planar sheet of a shape-memory alloy, self-expanding material by cutting; configuring said two-dimensional pattern into a three-dimensional configuration; and thermally annealing said three-dimensional configuration.
9. 13. The method according to claim 2, wherein said attachment struts have at least one articulation region.
10. 14. The method according to claim 3, wherein said filter struts are adapted to incorporate a radio-opaque marker without adding thickness. The method according to claim 11, wherein said pattern includes attachment struts and/or support struts.
11. 16. The method according to claim 11, wherein said pattern includes attachment struts, and/or support struts and/or filter support struts.
12. 17. The method according to claim 12, wherein said pattern includes attachment struts and/or support struts. N:\Melboume\CasesPatent\54000-54999P54436.AU.1\SpecisP54436.AU.1 Specification 2008-10-13.doc 2210108 00 -28- O o 18. The method according to claim 12, wherein said pattern includes attachment struts and/or support struts and/or filter support struts. O Mn 19. The method according to claim 16, wherein any of said struts are adapted to incorporate a radio-opaque marker without adding thickness. 00 20. The method according to claim 18, wherein any of said struts are adapted to ID incorporate a radio-opaque marker without adding thickness. O Os, N:\Melboume\Cases\Patent\54000-54999\P54436 AU.1\Speos\P54436.AU.1 Specification 2008-10-13 doc 22/10/08