AU2004200062A1 - Woven intravascular devices and methods for making the same and apparatus for delivery of the same - Google Patents

Description

09/01 '04 FRI 14:16 FAX 61 2 9810 8200 F B RICE CO.

Q005

AUSTRALIA

Patents Act 1990 BOARD OF REGENTS, THE UNIVERSITY

SYSTEM

OF TEXAS COMPLETE

SPECIFICATION

STANDARD

PATENT

Invention Title: Woven intravascular devices and methods for making the same and apparatus for delivery of the same The following statement Is a full description of this invention including the best method of performing it known to us:-

I

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:16 FAX 61 2 9810 8200 F B RICE CO.

11006 BACKGROUND OF THE INVENTION 2 The present application claims priority to U.S. Provisional Patent Applicatiou 3 Serial No. 60/118,211 filed February 1, 1999 and U.S. Provisional Patent Application Serial No, 60/125,191 filed March 18. 1999. The endre texts of the above-referenced s disclosures are specifically incorporated by reference herein without disclaimer, 1. Field of the Invention 7 The present. invention relates -generally to intravascular devices. More 8 particularly, it concerns self-expandable woven intravascular devices for use as stents, 9 occluders or filters, the methods of making the same, and the apparatus and methods for to delivery of the same into a living creature.

11 2. Description of Related Art 12 Intravascular devices that serve as stents or filters constructed using a plain 12 weave, such as the stent disclosed in U.S. Patent No. 4,655,771 to Wallsten (hereinafter, 14 the WAILSTENT), have a propensity to show a high-degree of elongation axially with is diameter reduction. This is especially significant, when the angle of the crossing wires is 16 close to the largest possible. The closer that the angle between the wires is to 180, the n1 more the corresponding elongation of the stem is at a given percentage of decrease in Is diameter. Any discrepancy between the diameters of the stent and theovessel can result in 19 a considerable elongation of the stent. Simultaneously, the woven type stent has the largest expansile force and hence the biggest resistance to outer compression when the 21 angle between the crossing wires is close to 180'. In some applications, such as outer 22 compression by a space occupying lesion, the ,incrased radial force may be 23 advantageous. The disadvantage of a propensity for elongation is that great care must be a taken when delivering such a stent in a vessel or non-vascular tubular structure in order to properly position it.

26 A further disadvantage of intravascular devices formed using a plain weave, is 27 that they are often incapable of maintaining their shape when bent. For example, when -2- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:16 FAX 61 2 9810 8200 F B RICE CO.

1007 such a stent is being delivered through a tortuous passageway with many turns, upon.

2 being bent, the weave of. the stent tightens the angle of the crossing wires 3 approaches I80*). As a result of this tightening, the diameter of the stent increases and 4 the length of the stent decreases, Consequently,.the diameter of the stern may exceed the s diameter of the vessel or structure through which it is traveling, impeding the delivery of 6 the stent or causing the stent to lodge in the vessel. This problem may be due in part to 7 the use of weave. materials such as stainless steel, which exhibit poor shape memory.

a This problem.may also be due to the free, unclosed wires used to form the stent. The free 9 sharp ends can create potential complications by penetrating, or perforating the wall of the tubular structure where such a stemnt is placed. Further, steps that have been taken to 11 eliminate the free, sharp ends, such as connection with U-shaped members using welding, 12 glue or the like (Wallsten, 1987) are tnf-consuming and expensive. The delivery 13 systems for such devices have also suffered from problems relating to the 4 repositionability of the devices as they are delivered into position in the living creatue.

is In stenting long arterial segments, the contiguously decreasing diameter of the is arterial system from the center to the periphery may pose problems. Woven stents with a 27 uniform diameter will exert a substantial expansile force to the vessel wall along the Is tapered portion. Additionally, the stent may remain more elongated in the tapered 19 portion. In a study where WALLSTENTs with a uniform diameter were used to bridge central venous obstruction in hbmodialysis patients, it.was. found that the stents which 21 were selected according to the size of the larger diameter central vein exerted a considerably higher force to the.wal of the smaller caliber subclavian vein (Vesely, 23 997). Simultaneously, the lnth of the sents in the smaler caliber vein was longer thai 24 expected.

2s In the prior art, most of the filter designs except for the Bird's Nest filter (Cook a Inc., Bloomington. IN) have a conical shape and are anchored with multiple legs in the 27 wall of the cava The concal design is used because the main stream of the blood carries 2 the thrombi from the lower part of the body through the center of the inferior vena cava.

29 Therefore, all these devices are designed to have good filtration capacity at the center of -3- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:17 FAX 61 2 9810 8200 F B RICE CO.

008 I the cava. The situation is quite different after ome thrombi have been successflly- 2 captured. The center of the cava will no longer be patent and as a result, the blood will be 3 diverted from the center to the periphery of the -cava. The aforementioned designs, 4 however, are not capable of catching thrombi effectively at.the periphery of the lumen so the patients will practically be unprotected against subsequent peripheral embolization 6 (Xian, 1995; Jaeger, 1998). Further, most of filters tend to be tilted in the cava which can 7 deter their thrombus-capturing efficacy. Additionally, except for the Simon hitinol filter S(C.R. Bard,.New Jersey, NJ). the aforementioned designs. require a fairly larg fanvasive 9 delivery system of 10-F or larger.

s0 The uniform caliber of cylindrical stenms in the prior art used in the ureter, as well I I as the peristalsis arrested at the proximal end of the stent, has resulted in severe 12 hyperasia of the urothelium and eventually occlusion of the ureter.

13 Turning to occluders, petcutaneous occlusion techniques have become 14 indispensable tools in minimally invasive management of a wide range of pathological is conditions. Use of permanent mechanical occlusion devices has been shown to be ie equivalent to that of surgical ligation. The Gianturco-Wallace stainless steel coil (Cook 17 Inc.. Bloomington, IN) has been the most widely used permanent, expandable as intravascular occlusion device for transcatheter delivery (Giantuco e L, 975).

19 Percutaneous coil emmbolization has been -shown to be, dvantageous over traditional surgical procedures in treatment of lif M t i reateni i g hemoirhage due to batuna a or obstetric emergencies.(Shwat et z 1993; Teitclbaitn et ai. 1993; Selby Jr., 1992; 22 Lve c y t aL., 1991 Ben-Menache edat, 1991; Vedanthm e at,. 1997). Frthennor, as coils have been used alone or in combination with microvascular embolic agents for the S treatment of vascular fistulas and malfomations, tumors, and varices (Wallace erat, 2s 1979; Hendrickx et at, 1995; Furuse eat. 1997; Whiter aL. 1996; Sagar of at, 1998; 26 Punekart aL, 1996). During the last few years, the transcathetr closure of the patent n ductus anerieos (PDA) with coils has become a frequently used techlique ijaf I and 28 Geggel, 1994; HIjazi and Gegl, 1997).

-4- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:17 FAX 61 2 9810 8200 F B RICE CO.

aoo0 I Although coil type occlusion devices have shown at least a degree of utility, they 2 have a number of drawbacks that could be significant in some applications. Intravascular s stability of the coils has been shown to be highly dependent on proper matching of coil 4 diameter with the diameter of the target vessel (Nancarrow et aL, 1987), and with the s exception of small vessels, a single coil rarely results in a stable occlusive thrombus 6 (Hijazi and Geggel, 1994). Moreover, a long vascular segment is often obliterated 7 because of the frequent need for multiple coils and the coils often remain elongated a within the vessel because their unconstrained diameter is larger than the vascular lumen.

9 Furthermore, delayed recanalization rates of 37%-57% have been reported in humans within 1-3 months after initially successful coil embolization (Sagara et at, 1998; 11 O'Halpin et al, 1984; Schild et al., 1994).

12 These and -other drawbacks have- inspired modifications in the design and 13 technique of coil embolization. Recently, detachable microcoils and macrocoils with 14 controlled delivery have-been designed to achieve a more compact conglomerate of the is coil and to prevent migration by allowing optimal positioning of the coil before release 16 (Zubillaga at at, 1994; Guglielmi etal., 1995; Marks et aL, 1994; Reidy and Qureshi, 17 1996; Uzun et at, 1996; Tometzki et a4, 1996; Dutton at a, 1995). However, since S optimal arrangement of the coil alone may not prevent migration in some cases, such as 19 high flow conditions or Venous placement, a coil anchoring system has been devised a (K6nya eat 1998). Although an anchoring system may stabilize a coil conglomerate 21 within the vasculature, significantly reducing or eliminating the possibility of coil 22 migration, such a system may render the coil non-repositionable.

23 Several different non-col devices have been designed to achieve a more stable, 4 limited size plug -with higher hemostatic efficiency particularly for transcatheter closure of larger vessels (Schmitz-Rode et 1993; Kato et a, 1997; K6nya et al, 1999) and 26 PDAs (Pozza-er aL. 1995; Magal wr aL, 1989; Grifkca etat, 1996); Recently, initial v clinical experiences with a new self-expanding nitinol-mesh PDA occluder have been 2a reported (Sharafuddin etaL, 1996; Masura etak, 1998). A similar self-expanding, 29 repositionable quadmple-disc device constructed.of a braided nitinol mesh and polyester COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:18 FAX 61 2 9810 8200 F B RICE CO. 0010 fibers has been reported to be supe riorto.st4ndard Gianturcot oils in experilental- 2 o.cluson of mid-size arteries(Sharaffuddin e .1996). 3 Although such non-coil devices may be TPositionable, they too exhibit 4 drawbacks.. For instance, the quadruple-disec device is several Centimeters long in an elongated fashion, making difficult to keep the superselective position of the catheter tip 6 during deployment. The multiple rigid connections between the layers and the relav 7 long and rigid Connection between the occiuder and the delivery cable further increase a this drawback. Atougl the nitinol mesh-PDA occluder has demonstrated utility, 9 proper placement requires a proper match both in size and shape between the occluder o0 and the lesion to be occluded. The type and qua ty of the connection between the h 't Of co ncto the II occluder and the delivery cable is the same as in the quadrupe-disc design. A common 12 disadvantage of both designs, is that they lack guidewire compatibility.. As a result, a 3 delivery catheter must often be navigated to the site of occlusion first before an occluder 14 may be loaded. into the catheter and delivered through it. Anoth relative disadvantage of both devices is their cost of manufacturing.

16 Percu taeou catheter technique for pera closure of isolated psistnty 17 patent ductus arteriosui (PDA) is now a treatmern of choice among doctors, obviatng to open surgery. The configuration of the PDA varies cnsiderably. A majority of PDAs 19 tend to have a funnel or conical shape due to ductal smooth muscle constriction at the 2o pulmonary artery insertion, although n wpin the middle or sonic ends b 21 observed (ric ko, 1989). That s the ason why not only the size but aso the 22 configuration, of the lesion playsa significant role in selecting an appropria occluding 2 'a int thei calibetr occluding %.devce. Except from the.small caliber. ions.(with. inMximum dianetr of 2.5 mm or 24 3.3 mm, respectiyely).:where some. authors have achieved successful closure of the PDA with Gi ulrco coils (Ca ,bier, 199; Lloyd, 1993; Somme, 1994), Rahkind's, "double 2 umbrella" occluder. is the -most Often used device .for this pus (Rashkind, 1987; 27 Hosking, 1991; LatsQn,: 1991.; Wesel, 1988; Report of the European Registry. 1992). It 2 Is avadiable two size (with.a diameter of 12.nm.aid 17 am) which require a -F and v re system r e ctively.

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:18 FAX 61 2 9810 8200 F B RICE CO.

Oil In the majority of cases,, the deployment of the traditiona PDA device is- 2 performed from a femoral vein access.(Report of the European Registry, 1992) Becailse 3 of the size of the delivery sheath, such a device is not suitable for the t-featment of patients 4 with a body weight of less than 8 kg. Using even a larger umbrella, this procedui is not s reconmended forthe treatment of the lesions with a diameter of 8 mm or above (Latst 6 1991). About.80% of unsclected patients with isolated PDA ae candidates for the 7 Rashkind device using the aforemenioned criteria (Latson, 1991). With the Rashind a- device, the proportion of patients with rsidua, flow through the lesion fell from 76% S mmediately after iinplantation to 47% by the day after implantation and to 17% by a year no after implantation (Rep6rt of the european Registry, 1992). According to some authors 11 the residual flow carries a potential risk of infective endocarditis and should be avoided if 12 possible. Its.abolishmant can be achieved by implantation of another device or surgery.

13 One of the main drawbacks of the Rashldkind umbrella is that it is not suitable for 14 occlusion of all types of PDA. Prefeably, it is used to occlude short PDAs with Is relatively wide end-openings. .Its two discs cover both the. pulmonary and the aortic 1 opening of the PDA. Longer.DA may hinder the dis to bepositioned in the proper 7 way, that is, paralel to:.ah other,.thereby de ter&orating its self-anchoring. Another is disadvantage of the umbrella is that the occluding capacity of the design depends i9 exclusively on the thrombogenicity of the porous Dacron material, frequently resulting in 2o partial d lengthy oluin.

Sor majoritygof, patients..with inary.ldage andor fistulas (mainly-due to tuw propagation to, ther,,urctrs), the diversion of urine is currently Peformed by a .percutaneous fnha. appr ofcah together with ur or clusio0. Formczly, detachable A and non detachable .balloons .were used .for this purpose, but they did not cause as satisfactory urteral occlusion. Migration as well as deflation of the balloons occurred z relatively frequently (Gunter, 1984; Papanicolau,. 1985) leading to recurrence of the urine 27 leakage. A Silione tretzral occiuder was develped and used with Wy limited success S b of de gration chez, 1988. s ulted i. eg and a9 consequent hoplete uteiferal oc.lusion. Iti ppe ha the eat 0rult have been -7- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:18 FAX 61 2 9810 8200 F B RICE CO.

1012 accomplished with Gianturco coils and Gelfoam embolization (Gaylord, 1989; Bing, 1992 a; Farrel 1996). Even with multiple coil placements, together with Gelfoam plugs, the ureteral occlusion may sometimes be achieved for only weeks or months, and was attributed mostly to the induced urothellal hyperplasia (Bing, 1992 Coil migration was frequently encountered in these studies. The lack of appropriate selfanchoring results in coil migration which eventually deteriorates the occlusive effect.

Problems pointed out in the foregoing are not intended to be exhaustive but rather are among many that tend to impair the effectiveness ofpreviously.knowh stent, occluders and filters. Other noteworthy problems may also exist; however, those presented above should be sufficient to demonstrate that previous techniques appearing in the art have not been altogether satisfactory, particularly in providing flexible, selfexpanding, repositionable stents, occluders and filters.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

SUMMARY OF THE INVENTION In a first aspect, the present invention is a device for delivering an axially and radially expandable woven body having two ends into an anatomical structure, comprising: a first tube configured to accept a guide wire; and a second tube configured to fit over the first tube; wherein when the tubes are used for delivering the axially and radially expandable woven body, one end of the axially and radially expandable woven body is secured to the outside of the first tube and the other end of the axially and radially expandable woven body is secured to the outside of the second tube.

In a second aspect, the present invention is a device for delivering anii axially and radially expandable woven body having two ends into an anatomical structure, comprising: a first tube configured to accept a guide wire, the first tube having a least one pair of first tube holes positioned proximate one end of the first tube; a second tube configured to fit over the first tube, the second tube having a least one pair of second tube holes positioned proximate one end of the second, tube; m:\sped I 1 0 0 0 1 14 115 115l3soatl.do COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:19 FAX 61 2 9810 8200 F B RICE CO.

Z013 a first securing wire configured to be threaded through the at least one pair of first tube holes; and a second securing wire configured to be threaded through the at least one pair of second tube holes; wherein when the tubes are used for delivering the axially and radially expandable woven body, one end of the axially and radially expandable woven body is secured to the outside of the first tube with the first securing wire and the other end of the axially and radially expandable woven body is secured to the outside of the second tube with the second securing wire.

compressing the body.

The present invention overcomes the problems inherent in the prior art by providing a self-expandable repositionable device for use as a stent, an occluder, or a filter which may be formed using a plain weave, and may have closed structures at both its ends, In one respect, the invention is a device that includes, but is riot limited to, a plurality of shape memory wires Woven together to form a body suitable for.

implantation into an anatomical structure. The body has first and second ends. The shape memory wires cross each other to form a plurality of angles, at least one of the angles being obtuse. Both ends of at least one shape memory wire are located proximate one end of the body. The value of the obtuse angle is increased when the body is axially compressed.

The shape memory wires may be made of nitinoL The shape memory wires may be made of FePt, FePd or FeNiCoTi. The shape memory wires may be made of FeNiC, FeMnSi or FeMnSiCrNi. The shape memory wires may each have a diameter ranging in size from about 0.006 inches to 0.012 inches. The plurality of shape memory wires 8A m:Aspeci\1100001 14-1511 15663boatjl.doe COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:19 FAX 61 2 9810 8200 F B RICE CO.

16014 S may include at least 6 shape:memory wites. The body may have-a tubular shape with A 2 substantially uniform diameter. The body may have a tapered shapewith a diameter that 3 decreases from one end of the body to theother end of the body. The body may have a n hour s shape. As used heinhrglass" sap is a sha that resembles a body having two ed that arm larger in tezms of crosssectional area than a 6 mid-portion located therebetween. Such shapes include those resembling traditional 7 hourglasses or dumbbells, for example. The body may be woven by hand, The body may a be woven by a machine,.,uch as a braiding machine. SThe device may also include, but is not limited to, a graft material ttached to the body. T, graft al may be made from woven polyes gat t h ed toa thie 3, made from Dacron. Thegraft material may be made from polyuretane. The graft 12 xiateial May be made from m graft material way partally cover the body. As IS used h6rin, a graft maerial that "partialy covers" a bxdy is attached to the body such 14 that a portion of the wire or wires forming the body are left bare or exposed. As a result S of only partially covering a body, blood or other bodily fluids may flow through the bare 16 portion of the body rclalvejy unimpede by the graft material i7 The device may also incld but is not limited to, a first tube that i' configured to 118 ao g'uide wine and a sec;nd Tube that:j u~ i b cofd that gured to fit over the first tube. Prior to 19 delliefAng "e iit S delvenng the body iint an anatomical. structure, the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is 21 scured toth seond. tube, 2 In ater respet, the invii0on is a devicea iIlud, but is not imited to, a 23 bod swt4be for imp.antation huo en aoncal stwctumr the body basa fit end, a seo d uT is defi by at least a sh m ,ory ,Wi4 where n is greater one. Then shape memory wires are arranged such that the includs a6 n S The, -t portion includes fist wyen Ioipni and. t met, The shape memory 2 Wi th firt oven p io. other to fq, plurahit of angles,at least.one 2* ofth angles being btue. Both. p of on elmy wie arelocated COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:20 FAX 81 2 9810 8200 F B RICE CO.

[a015

I.

proximate one end of the body. The value of the obtuse angle is increased when the body is axially compressed.

The shape memory wires may be made from Nickel Titanium alloy (Nitinol).

The shape memory wires may be made from FePt, FePd or FeNiCoTi. The shape memory wires may be made of FeNiC, FeMnSi or PeMnSiCrNi. The first portion may include a first woven portion separated from a second woven portion by multiple first struts.

The body may also include, but is not limited to, a second portion located adjacent to the first portion. The second portion includes a second woven portion. The 10 second portion has n x shape memory wires, and x is at least one, The first portion may have a generally domed shape. The first woven portion may have a generally domed shape and the multiple first struts may be bent slightly so as to increase the selfanchoring capability of the body in an anatomical structure. The first portion may also S include a third woven potion separated from the second woven portion by multiple second struts. The first and third woven portions may have generally domed shapes.

The device may also include, but is not limited to, a graft material atached to S the body. The graft material comprises maybe made from woven polyester. The graft material may be made from Dacron. The graft material may be made from polyurethane. The graft material may be made from Polytetraftloroethylenc

(PTFE).

The graft material may partially cover the body. The device may also include, but is not limited to, a first tube that is configured to accept a .guide wire and a second tube that is configured to fit over the first tube.

Prior to delivering the body into an anatomical structure, the second tube is placed over the first tube, one end of the body is secured to the first tube and the other uend of the body is secured to the second tube.

In another respect, the invention is a device that includes, but is not limited to, a plurality of biodegradable filaments woven together to form a self-expanding body S suitable for implantation into an anatomical structure. The self-expanding body has a .rst end and a second end. The biodegradable filaments cross each other to form a m:speMt10000\114-11o11563sldoc m:XspecM 1 0001114-11 5~1l563soajLdoc COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 PHI 14:20 FAX 61 2 0810 8200FB IE o F B RICE CO.

11016 I pluralitY -Of a=9Ngles alast'one,-whijc. 'I-is obtuise. The' value of -the o:btuse angle Jif- 2 iflCreased:ben the -body is axially comitesaed., 3 The biodeSM#da)P. f']ainent, may be n~adp from polyg)ycoip; acid, The 4 biodegradable filaments myb maefrom poly-M Actic. acid.Thbidgabl adefro~~na olortbbiodenbAoe filaments may be mad frm y ocater. The fia ntmybead r6T fro a polyanhyd.ie The.. bloc! m ay be m f o m a W I adbl 7 polyIrniinocarboj~tg,_The biodegradable filpimn~myb~~c.rmw nra calcium phosp~mc The biodegradable fiaments may include about.0OhS to 9 by weight of calcium oxide, calcium hydroxide, calcium carbonate, calcium phoapliat, magnesiumn oxide, Magnesium hydroxide, inanciurn carbonate, magnesijum phosphate.

a, sodium: phosphate or potassium &ulfa& The bOl. degadable filamencts 'may *be nmade from £2 a-dye~ain buq5 to abut. 310 -n le. patent,'glyblidc. At last "one of the, 13 -biodegradable tilainenta may be mde from paulitaxel, d6cez-xeI o6r hepsri. Both ends of 14 atleas one.biodegradable 'filament may hoNatd prite tjhe first'jma -of the selfis expanding body. c n ftesl-xpnigbd a nld at -least one dose 56 'Struicture.CII 17 The device may also include, but is not ti t, At. leat prw sape eoyw to secured to the self-expanding body. Both ends of theq Oneo 19 located proximate one end of the self-oxpanding body..

In another respect, the invention is a method of ecating a body sui Al for 21 ImiPlantation into an anatomicalj strature. The body baa ",,oend. ends, The1c method 22 includes, but is not limited to, bending the shape inrmory wiq i luay of shap 23 memory WU o rat. oitions in thefg shae 'enyws. -The e~prin i 24 arrangled.to define one end of the body. Each shaem"z i~l~slw ns i method also Includes, but is' not limited to w eao-#) ne e moryIA 26 to create tebody such that t4# shapemeoywrscss 9lrtfppur)y 27 pf angles, at ,least One 'of the :Anl belniobt jUf 'hvalueq'te lheugpi as icasd when the body isaxzy A 'i COMS IDNo: SMBI-00564368 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:21 FAX 61 2 9810 8200 F B RICE CO.

[a017 The bet portions may bp bends or kopt The shap memory.wires may be made- 2 from nitinol. The shipe rnemory wires way:biade of PFP, PFPd o-r-FeNiGoT The 3 shape memory wires may be made of FeNIC, FeMnSI or PeMnSiCrNi. The shape 4 memory-wrds may enc have a ameter rangig in si fibmabo t o0o6 inches to about 0OO12inches. The plurlity of shape memory Wmirs may include ii 1easi 6 Shape memory a "wires. The bdy may have ablar shpe witha substantialy uniform diameter. The 'body may have a tapd shape with a diAdmeter that decreases trm one end of the body S oite othr end'of tiheody. Thbdy may haivW pn"erialy hourglass shaW The body tMy bWoven by hdT body be women' i mahine, sch as a braiding fj IJ In anotherrespect, the invention is a method of ceadjitg a body auitablefor 12 .implantation into an anatPmical stn cture..!he body has two ends. The method includes, 1s but ,is not limited tP,,providing a. weaving system that includes a template having first JA template pvjections. The method also includes, but is not limited to. bending shape 1s nzmory wires around the first template prqjections to create.bent portions-in-the bape 16 memory wires. The bent portions are arranged to define one end of the body. Bach shape 17 memory wire has two ends. The method also includes, but is not limited to, weaving the is ends of the shape nmory wires ariund the template to crte ie by such that the 19 shape nemory wires czks each o ther to form a pluraity of angles, at lest one of the angles being obtuse. The value of the obtuse angfe is increased when the body is ayxialy 21 compressed.

2 The fir~t teiplat' projections may be tabs. he frst template proj ons my be pins. TIhe plinis May be attAched toting engaged vi th tejae 23 w theuvaThe weavigsstem 24 roiy als in t is not limid to,al cnf dt rotate in a fsist direction during the Weaving& h nig yte a s Inud ut is ot dto I first bobbint arflged on the first weaving plate ind one and ofah a o 27 is Attached toechi first bobin pinor to the weavig Th eaving system m ay a]s0 28 Inclde, but is not liSmitd a second weaving pla conflgun4 to rotate in a A~cond directon duing the weaving, and the second weavng plate Is spacd apart from the fist -1-Il COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 00/01 '04 FRI 14:21 FAX 81 2 gala 8200 FBRC O F B RICE CO.

Z01l8 wavihg P1W... The. weaving, Ssawu myas include, but -it: iOt: limited to, Seconcr" 2 bobbins nnnedonth'asownd-weaving plate, ando-ne 'end ofeech shape memory win is 3 :attached to C5hs%;ondbobbin prior-io-the W sring. 'The method may alsb include, but 4 .%ignotimtdtoisecurlng zhe'ahapenewrniy-wirn toizhe temhplate. Theinetbod my also include,- but is ot limited. to;, fonrlng. closed structuewihteensotesap 6 memnoxy "wires. The closed, structures may be araged to -defic the 'other, end of the 7 body The -method .may also incdlude,- but "is not- lhnlced to, heatirig h oy n h a template. 9In another repct 1 the invention is a device for deli vpring fl Axially and radill w0 expadable w~ven body havn twp ends ,into. an aatnilsrcture. The jlevIj 11 includes, but is not U~mlt~,afrttncnied to cetagiewradascn 12 tube configured to fit over -the first tube. Whntetueax ueic dlvrL I f" tetb 4_Oeueb1 0 yr te 13 axially, and radifaly exLpndable woven 'bdoeand of the ailyadrda~ 14 ekpAndable woven body is secured to the outside of the first tube and the other end Of the 1n axially and radially-expandawle Woven body.iuaecuredto the outside of the second tube.

mad The first tube maay be made from NYLON or ThP.F N .h c uemybe 17 maefrom NYLON or ThPLON. Th. device may also includebtino igetoa is Oude wire confre vore~cod, wihnte Jube. The .D diameter of thefrt to tube myrange iszefrom 3 FRench to? EpreckL The oute diameter of the second tube MY range in, size from 5 rnch to 9 FReach. The device may also include, but, is pot .21 limited to, a push-button relenas/ock mechanism confipuzd to secure the first tube to th e 22 second Th. device. may also include,--batris ao1t.Ilixnted to,-An- end fitting "having a 23 a!ide sMut The end fitting .is owngied,.obe securedto the .fit Mue h is uesa 24 bDpole wt tlaTwtPqW 0pf firsttube holcrnlrou~h which. s-fwwseuring-wire r.My be threakle& Thepai of first tubs es my be positioned rximate n ndoh as frst uba.Th econ tub' may bepoviddwith: at leakt' one: paid ofsecnd ,tube hole $wthugh- Which. second, secinug wiremay be thee; Te pair of' second, tube holes 2U "MYb'~indPbi~q:n n ScnlW' COMS ID No:S51-00564365 Received by II' Australia: Time 16:21 Date 2004-01-09 09/01 '04 FRI 14:22 FAX 81 2 9810 8200 FBRC o F B RICE CO.

10I019 Jn amotherrespwctthe invention is aL.cfviccfodevuinsxasadrdaly 2 czxpandabl Woven body ,.bnfig- twoisnsitnSaoicFancue h vc 3 Include0, *bpt i9 not lirpted xt% firs uecniue oucp ud ie h is -tnb ha .at, least on pama is uehlstataepezog rxmt one -end of'the flat tube deice.also includes butn isDofirie to.asecond -tabeConfigund to..fit 6 .Over the first tube, Thie -stc ondb ha at -east One pair-of second'tube-.hDles thAt ar 7 positioned proximate one end. of, the -second -tube. The device aItso..iucludegLbu. ,is niot a limited to, a first securing wire configured to be threaded through the pair of first tube 9 holes. The devic'e also includes, but is not limited to, a second securing wire configured to to be threade .d tonkithe pair of second til.hls hithe tubes-iiz used for at deliverinig the aicillj A'n:adradially 6xpa ndable 'woven: body, onie end of the axialij and 22 ildillyexpadabe io~rn' bdy s s~nrd to teotuiid, of the frst tube with the first 13 sectiftg Wirie and~fi be'ohrend of thetaxially and'iidiallyexpandable wdvcn body is 14 seur to the outid o the second tube with the' secon sung wir.

is In anotherrespect, .the invention is an-occluding aystemn that -includes, %but is not 16 limited to, a plurality'of shape memnory wires woven together to form a body usefu for 17 o~ccluiding anAlitomlcaj structure. The bod hs first andlecond ends, Both ends of at 1i iatone shp m 'oywir am locatedproximate'onei endfthe body. The shap n9iemory, wires cross each othfer to foima plurality oangles, at least one bfthe angles 1eibts. h value* of the oibtuse aingiA Ish aadw the body -is' mal 23 alowioudoj, bin is300t-JAihcd to,. .anz occluding ag -ntulsecl within -thlbody, lbhe 4ccluding apqtji;Ly Include ogntor m hds :of-polyeaten -The occludigagent may alo ncud. utIsnliuxib~ pbor more thed fAC 0MN. The cudit 26 -systqa) my -Aso, lfclut a-Jacket couoled IT i bd. rho jiackemA b-made front 27 uilicor, Thc, Jcket .m h madeir4m -polelh m z i nThe.occudjgaystm ma aW lso 2a include. but is not limited to, a flttube conligured to. acvqept a iewira and. atccrd 29 tube configured to fit over the first tube. Prior to delivering the body into an anatomica COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:22 FAX 61 2 9810 8200FBRIE&C.102 F B RICE CO.

[a 020 2 of tebod is ecured tf.. the oiscr tth-utside of the -firond tube.n heod d M. :j .sIn anoth er respect, the invention is a. ckviqe that includes, but is not limited to, a 4 body suitable for implantation into an anatomical structure. The boyhas an axis, afirst s end and a second end. The body is made from a shape memory Wire that has a first segmpfl, and 4 secondi segment..The segments rcseparated -by a bend-Ain she shape 7 Memory wie tt'is. located proximate one endof the-body. :Thefirst segment extends s helically in a -first .direction, around teaxis ,toward $bae. Qzherad- of the body. -The second 9 :scgxncnt nteads helically in a second direction. arowlid. the Wxs -toward. -the- other end..'of i0 tebody. Th- firs-t and. second~segments cross each othier in .a plurality Of locations.

it The first segment may be positioned farther from the axis than the. second segmet h2 at at least one location. The first segmn maky be positioned farthe from the axis than 3 dwe second segmnt at eah ocatio The shape memor wire aIy be made .from nitinol, 14 The device may also include a first tube configured to accept a guide wire, and a secondi to fit ova the, irat-tube. Prior soucvdng the body into an atomica 36 swwre, one end .of the bodyis 50gure t'heoutsidayo the firartube-and -the othertend 17 Of dietody lspcure~st be.outsideof the eobs us is In another respect, the invention is a device that includes, but is not limited to, a 19 body suitable for nplasnadon zno an anatomaical structre Tbo body hasa frst end and z0 asecond en.T'he bdyis fonied from a shape .Mmor'y wire that has a ftis s'egment and 21 A secod segmt. The segments at scpsrutd by a bedin ':the wire that is. locate prwinate one end of the body. The firs segmednt and second semnsa arnwt 23 form loops and Musied segmts such that at least two contiguous loops ;qe soopated 24 'from another loop by a Mwited segment. The definidon of -contiguous"' is set font 26 At least three conuiguous loops may be separated fromn anothe loop by a tMated 21a sePLen t. Mleast tonrco6nigiuouuloops Par!'. a loop by atwiste .sp LAt lcat-two contiguous loops mpoesprtd, firnttwo othe consiuous COMS ID No: SMBI-0564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:23 FAX 61 2 9810 8200 F B RICE CO. 1Z021 toopa by.a twistal segrment. :Theisaap.mn yowire.may.be ade-from nltholL -The- 2 device may also include, but is ,n6t.Timited i, aO first:tube -oifigured to acept a guide 3 wire, and a second tube configured to fit over the first tube. Prior to delivering the body 4 into an anatomical stnicture, one end of the body is secured to the outside of the first tube and the other cnd of the body is secured to thc outside of the second tube.

6 In another respect, the .invention is, a device that includes a body suitable for 7 implantation into *an aitomical structure. The body has, blut is not llIited-to;.two.ends a andis fan edfroiashape m am y wetthat b-ha first segment and ieseondsegment.

9 Thesegr ntst a.separated by abend in the wire that is locatcd.proximate one ed ofthe 1o body. The segments are positioned adjacent to each other in loop-defing locations. The 11 segments also extend between the loop-defining locations in spaced relation to each other 12 so as form at least two loops. At least one of the at e two loops has a copressed 13 shape. The deinition of a 'compressd" shape is set forth below with reference to the 14 figures herein fto the sake of clarity. is The shape mewor wi may be made fromnitinbl. The segments may be sedted 16 -:together using .weldss athe loopNdf nig locations. The segiknts may be secAted 17 together with collars at the loop-decfting locations. The body may also include; but is not is limited to, at least one coil placed over at least a portion of one of the segments, and, as a 19 result, the body may be used as an occluder. The body may also include at least one fiber attached to the coil. The device may also include, m a frt tub may Inclu",. but is not limited to, a first tube 21 configued to accept a guide wire, anda second tube configured to fit over the first tube.

2 Prior to dlivering the body into an anatomical structure oe end of the body is seced to the outside of tie i '""tube and the other''ndofilhebody is seced to the on de of 24 the second tube. The present invention -also provides kdelivery-system that may secut both the 2 proximal and distal ends of the stent, occluder or filter. Advantageously, this delivery 27 system alows the stent; occiuder or filter to be easily repotiond as it is being delivered 3 into place. As a result, the stent, occluder or fliter maybe more precisely positfoned s within the living create.

-16- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:23 FAX B1 2 9810 8200 FBRC o F B RICE CO.

[a 022 O.Qqavaptage_ of the. prmsen invention: is the. unique, fxalo; mtho -of 7 tapered mient. The tapered shape of the stein allows the s~btnto 'be fixed In a. tapered a vessel or tubular structure with less radial or expansile; force than a straighit stemt might 4 exiiibi, thus'6 poitntially resuhigint aloe h"perpasti 'CIntimral reaction." s T1,e. straight scnt of t;preentinvenign e,*4uiia. hig-h expansie force 'and thus g a* wecapablt ofwt1nig u eomnpxaioao .Thbis. "may, beeseial adatgeousi tpru tnss rfbos titra(nldn radiation4nduced e stenoses)whereatets. withiuadequatq ex panlQ forc Cabe~easiiy compressed and/or ar-nm~l f.Biiigt) irhjna sh.apeandA 4in Wr nsome caes,:_even the atenosos of antedoiertc oign a !De G o .uifdegd...11w or renal artery stondies) Ii I chat extra, radial force is equired, from the stein to hold the patency of the vessel, 12 flhitrth e wotiiCa~su eis of the preeiiinvefidon are also able to J. 0"-1 34 A~~~vrnnMy ag"ouiytet, ocld anflesofhepresent inention dono Is posses free,,. sharp, wire ens. hs aypotntial1 .oiphciktions.arc eliminated 16 1Pal, 1Mr). AtOqualy. the t tight miesh,- of: t. u'Qata the pitsent Invention 17 coupled with the use of nitib)l wires, for example, makes them, easy to zmnitor. under 19 Tepeetivc~p loiwue a, group of ,Wrwtpeding, 9eLf-centering Cava z0 filter woven fom materials as described above.,4=hchat 4'cohero element. is 'foined 21 that without the use of a joint or attachmnt between the portions of the filter. The cava 22 fitrf te'p&Aftsen lvention proid inras U ilrtng efciency not only attecenter 23 but aso at the pcrijtr- oft uj,'Adtoay h orgiass fiter'of tepresent 24 I&IS. i, rs"' f th e nt inventon a A*hti haftodt"ir~ and -icir potentially 26 Ile ban.)%~'7 r th anfitSs ep t invet.ontmayu aMrarelatively-smfalL, 7French rit 281 COMB ID No: SMBI-00564365 Received by IP Australia: Time (I-tm) 15:21 Date 2004-01-09 09/01 '04 FRI 14:24 FAX 81 2 9810 8200 FBRC O F B RICE CO.

Z~ 023 I possible-nt deliver.,r hemyvia sny'of the.rssible nts'i6 f thehiinn boy (femoral;- 2 .jugplar, muiecibital v a3 The Present invention also inqludes a h-l c fter( I f t) th ti s ow 4 Profile, self-expanding, flexible, temporary filter which .may be woven from a number of Bupeattc tsaenewylo. Tbt B1lilt&r -is a type Of tdrmpcsaryfhzer that can be 6 'deployed from either, emipral vei1n 1 And it-can filt te ;the -blod.k M S iliac veln&/iAfedior 7 ca 0vajunetian.- The.-BI ,filter: of f &irptt invidn iixtypioily4 work at a-Sw of 9 comingro m both iliacvenpcisiglotio*fitonEuhrteeofheD .,filter is particularly bnfba n~rbezv nd~aamt as 11The inver.shqape of the 131ctr _togethler ihtz,~ sl f4re~ the 12 tubular wesyc ensures fi poji ln teiiaccva jution. ,APiThe advasgo 13 the present invention is that the BI filter May utilizea relatively small, 7French delivery 14 catheter or sbeath.,. Further, dzto SW' flexIbiits ef the ~mesh'bf th&Iflltr,' the delivery is systeni themeof maLy btrAdnncedfcklfM ipsk to a~r Inrila A vei& "'As wih -te a 17 The BI filter is suitable for temnporary filtration. The BI filter sflows fpr~m iepal to of the entrapped thrombi safely and successfully before removal of the filtier. Using an it adegmrtelysized, sheath lkit sai thatnbus f gi nt Wenapjdwthn h ms could .nsabe r ovedtopther wih .thcfltr 21 The ;tcts. of the present ineto 4a eavatgo.ypvrdwith materi#1a 22 Suc a k r._lyurcthane, and/or an ow thto 23 reduce thpossibility of retnsalfter Idslivpy ad whihqlsoQlQow.the stnt to be 24 toed in stenting maignant seqss for exa le TheM filters of th pment inventionwy 2S also be covered with anticoagulant coating agents.

26 Ureter stricu pesiiocu be -o d,1l0% ithm use ncovered 27 and/or covered stents; in iluw h s f~o tecdf wY14 aataseousl 1 0 Y COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:24 FAX 61 2 9810 8200 F B RICE CO.

S024 match the special conditions posed by the different caliber and distensibility of the different segments of the ureter as well as the constant peristalsis.

The stents of the present invention can also be used in some non-vascular applications including biliary tree and tracheo-bronchial system if the lesion does not require a bifurcated steat.

The stents, ocoluders and filters of the present invention may be used in many different applications. They provide the advantages of superb flexibility, repositionability/removability, and precise positionability.

Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

BREIF DESCRIPTION OF THE DRAWINGS The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the description of illustrative embodiments presented herein.

FIG. IA is a perspective view of a stent according to one embodiment of the present invention.

FIG. 1B is a front view of a stent end defined by bends according to one.

embodiment of the present invention.

FIG. IC is a perspective view of one wire of a stent according to one embodiment of the present invention.

FIG. 2 is a side view of the arrangement of wires in a plain weave according to one embodiment of the present invention.

FIG. 3 is a perspective view of a delivery system according to one embodiment of the present invention.

FIG. 4 is a side view of a delivery system according to one embodiment of the present invention.

19 m;speci\110000\114-1 Il15663soatJI.doo COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:24 FAX 61 2 9810 8200 F B RICE CO.

[a 025 42-G& SAsRequentialyl .41trn&ve steps t in a dclvery mthdd according joone- 2 embodiment of the presentinventioni FIG.6 is a front view of a conical filte rhavig bends oi loops in the proximal 4 (rMrend thereof actording td-imetnlbodinet of the refent invbntioi FIG 7-safotve FIG.? is a front view of a conical filter having bends or loops in the distal (front) 6 rend thereof according oan embodimentof thepmsent in to& 7 IG. 8 is a. front view of adome tr Px 4 4i thereof according to one embodiment of the present invention.

9 FG. 9 is a front view of an hourglass filter according to one embodiment of the 1o preselntinvention, 11 FIG. 10is a front view ofan bouacsscfilter.a=ording to one enbodisppnt $the 12 present invention placed in the Infeiox Von Cam. 13 FIG. 11,is a front view of a bi-iliac fke c in tonce nbodimcnt of the 14 present invention placed in the iliac veins.

FIG. 12 is a front view of A bi-illac fter baying a retrieval lop according to one 6 embodiment of the present invention placed in the'fliac viiaps.

SfG. 13 isafront view P b c ler a b Millo and stbilizing is wire according to one embodiment of the present invention placed4 $acr ens.

-0 F7G. 14 fr. a isa.perspective vlew of A tpmp

~LU

=pectvfd-at acrn.. tofleqapbodinjgnt z Of the present invention.

21 MFG.15 is a pen wo 4 ire. o n w r t, a.s4ft7,4cborqiig to one n embodiment of the present invention.

23 FIGS.. 1624 show stAM in a etbp pcgocdt to one 4 embodizn of thie present invention..

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:25 FAX 61 2 9810 8200 FBRC O P B RICE CO.

I1I 026 F IG, 25i.o4 front view at the proximal poniok of a dbIivery jystem according to.

2 One embodiment of the present invention.

a no 5 26 is a -front -view of a de livery system for a -temporwy fil .ter'according to A one embodirnent of th6 present inventicin, FIGS. 27A and B 'illusta-ate. stages in the t'emovtl: o6f a filter from a vessel 6 according to one embodiment. of the present invernion, 7 FIG. 2$ is~a frent view of a conical filter in -a fully ttretched posit-ion, ac .cording to a one embodiment. of- the present inventican 9 FIG. ;9 is-a projecctetvws section of. an hourgla fziltera. -tke across the middle 1a portIon of the flterm~ bccrdugowaunmbodlment'of thapbsent invention.

11 FIG. 30)A is a front view of two wires coupled together for use in a hand weavin g 12 mrethod according to onerembodiment of. the present invention. 13 FIG. 30 is a perspective view of the placement of two wires each coupled to a 14 -pin for use 4aband.- wcaying, method according to-, onew enodimec thpren Is invention. 16 l~3 sa Jmpedt lw of a ,biodegwa-dablc st "With rarenforting wire 17 aOfttDloop eIidszof, tkorssnnbn-&-> isFIG.32 is a perspetive view of abic'edaptexns with eifrcn wr 19 according to a seqond embodiment of thb present invention.' FIGS. 33A-G'are froint' views Of various con flguraitiona o 23 to the present invention.

22 FIG. 34 is a front view oqf:an peldr ai .Ct n 23 rboleno the present invention.A.'- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:25 FAX 61 2 9810 8200 F B RICE CO. 1]027 .1 fl,'TG. is a fjvew-d gi;:p-enlud.-bavi&cups. centngt ombodimnt, 2 of the present invention. FIG 3 is frnt .View of an .aufut n being- treated by. tanscatheter 4 embolization according to one embodiment of the present inventit.

s FIG. 37 is perspective view of a template with longitudinal tibs ar6und which 6 wires are bent according to one embodiment of the pesent inveition.

7 L. .E 38Aj s.anp elarged perspective view.of the longitudinal tali aid bent wire I depicted in FIG. 37 according to one embodiment of the present invention: 9 FIG.3 ,is anenlargedperspecive view.ofa longitudinal tab depicted in MIG 37 around which a wire, is bent-to fonnm:a loopaccording t o' one mbodinlent of the 11 present invention.

12 FIG. 39 is a perspective view of a wdre bent around a longitudinal tab and 13 wrapped around a pair of bobbins according to one embodiment of the present invention.

14 PIMG, 40 is a top view of inner and outer weaving plates provided with bobbins is according to one embodiment of the present invention.

is FIG.41 is,a.pespective-view depicting ianupper.weaving plae prided with i7 bobbins and wires, a partial cross-saptional view'of.a lower weavingplate-provided with is bobbins and wires, and a partial cross-sectional view of a template around which both t9 plated are an According to one embodiment of the present invention.

FIG. 42A is a top view of upper and lower weaving plates provided with bobbins 21 and wirs ad aranged around a template, and Illustrates the first crossing of the wires 22 according to one embodiment of the present invention.

aI42 iadtow b y bin'a sma caliber oop m by nding a wi 24 according to one embodiment of the present invention. -22- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:25 FAX 61 2 9810 8200 F B RICE CO. Q028 43A is a top view of upper and lower weaving pltes proided with bobbins 2 and wires and arranged around a template, and illustrates the flistcssing of the Wires 3 according to another embodiment of the present invention, 4 FIG. 43B is a front view of a bend formed by beiding a wire according to one s embodiment of the present invention..

6 FIG. 44 is a perspective view of upper and 16wer waviing:plates provided With 7 bobbins and arranged around a template such that the surfaces of the weaving plates from which the bobbin rods extend face each other according to one embodiment of the present 9 invention, 0o 1G. 45 is a perspective view of upper and lower weaving plates provided with i bobbins and wires and arranged around a template such that the surfaces of the weaving 12 plates from which the bobbin rods extind face. each other according to one embodiment 13 of the present invention. 4 fG. 46A is -a perspective, partial cross-sectional view of.a tool for twisting the is wire ends of a woven body according to one embodinentof the present invention.: i6 F GQ..463 is a cross-sectional view of the jaws and outer housing of the tool 17 illustrated in FIG. 46A. tis FIG.47A.isa perspective view of a body. woven .around a. template having 19 longitudial and tan ere tabs ac ording to one embodiment ofthpresent inv a tio ri FIG. 47B is an enlarged perspective view of one of the transverse tabs and twisted 21 wire njlsdepiqte4min. IG 47Aacording to oneebodiment.of the present inention.

22 FIG. 48 is a perspective view-of a template around which a ring having finish pins 23 has been threadably engaged according to one embodiment of the present invention.

2 FIG. 49 is a perspective view of a template having finish holes though which 23 finish pins may be placed according to one embodiment of the present invention.

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 t04 FRI 14:25 FAX 81 2 9810 8200 FPB RICE CO. Q029z FiG. is a tnt View of' aIstein twinid from ipgl Wire a.ccorning to one- 2 emlbodimen it oif the prcsm.t Invention. 7 a FIG, SOB is a front v iew of a stent fanned from a single wire acording to a 4 -second embodiment of thepresent iDyefltOU.' ~FIG. 50C is a front view of a sten farmed from a single wire according to6 a third 6 embodiment of the present invenli~n. g 7 FlG. 5OD is a-perspective vi'ew ofthe stet; depicted in FIG. SOB positioned on a 9 template according to one embodiment of the present invention.

0 FIG. 51 Is a perspective view of a barbicas stout filter according to one t0 emibodiment ofie p res-ent invention.

.11 AFIG. 52 is a perspective 'view of a- bivblasi sten fllin'havintg bent li~uia 1z segments according to one embodiment of the present invention., 13 FIG S-s&npCv-Vb fkab6ssetfilteriitvlft two 6fllttn levels 14 according to one. embodimn it fthe preasint invention,"- 135 flG.54 is -a front view of-two sterna placed-IA, sid-by;-idc reliinrship with each 1 other in the arta according to one embodiment of the present inventiion..

37 FIG.- i's a-perpccdve.rstf two partially-covmred Stems placedi gr ide-b'y- Is side. miationship with each othetin drt' acdrt accidrding to obs e abodini~t bf the tewt 19 invention...t FIG56it pespetie iewofa saibhving tffplcdi sldeaby-side 21 relationship with another swenr In the aorta according to one embodimept of the present 22 invention. 23 FIGS. S7A is a front view of an owluder formed from a singl wi rq around a 24 template according to one emibodiment of the preset hwvention.

.7I.

S. COMS ID No: SMSI-00584355 Received by IP Australia: Time (I-tm) 15:21 Date 2004-01-09 09/01 '04 FRI 14:28 FAX 81 2 9810 8200 F B RICE CO. Q~030 11 FIGS. 5713 is aj perspectiverview of an q~ccluder formed from a single wirle thEt 2 in~lo~ca collars placed around the, wire segmhents, at loop-defining locations according to 3 ono eodmn of -epresent invention.

4 PIGS. 57C6s a top view of an occludei- fonned from a single..wire that has- coil s pieces Placed over portions of the wire srpnents located be~tween. collars according to one 6 embodiment of the present Invention.

7 IGS. 57D is a top view of an occiuder formed from a single, wire that has coil s pieces placed 6ver portions of the wire segments, ]octe4 Ntween, collars and also has 9 thrmbogenic filaments attached to the coil pieces according to one empbodiment of the to p1remet invention.

11 -FIGS. -SA.Dsh'ow -staps in the' delv&ryo-cf onea steitof a aiofstes in- the 12 aorto-rmnal junction according to one embodiment of the pentinvention.

13MI., 59 i a from fviewao a batb (of 'a filteri) that* is, penetraing a- vessel wal 14 accordling to oic -embodiiet of the present itvcntion.; is FIG. 0 isaperpective viqw of a single wire embodiment filter accordingt 16 another embodiment of the present iveto 17 -FIG, 61is a1 fr~loq6w of ujjerand low& alg ltssupre by a2eain is plate.kupoe accoingtfl t4u. ofth'fesn inviton 19 DESCWiPTION OF ILsUSTTVE I4QDJMErqT 2. .g SV a 23~1, Wizl~ efgene to he ilIs~Wiv Ombo$$~3 41; zfO 4 teei hw 24 tnt J~fif l~~vynOq &19llqit~~l h t~tnldsatirlt 24 10V* hc a e ey o st.deiea lqiai 23 efccabk pdyd. ~'M 1 j~qW5, OjU~C~ll 'deonnale _0e9a thatio COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:27 FAX 81 2 9810 8200 F B RICE CO. Q031 I deformation of such a body is:.nonpermancnt md original or .iiiat shape may be-' 2 substantially ,ov.e ed, or regainedIupon.' the release -of force -(which ,may .be 3 mechanical, electromagnetic, or any other type bf force). Aused herein, "substantially 4 recovered" means that recovery need not be such that the exact, original shape be regained. Rather, it means that sorne degree of plastic defoknmation may occur. In other 6 words, rcovery n~ed not be total, Such elastic deformability may be achieved by 7 utilizing the superelastic properties of suitable shape memory wires, which are discussed S below., 9 U.S. Patent No. 4,655,771 to' Wallsten (1087), which is hereby expressly incorpfoied y' efaience, displays th tianner in which wires cross each other using 1t plain weave as shown in FIG. la therein. FIG. 2 also illustrates the manner in which the a2 .wires 5.of the, present intravascular devices ma y.be-arranged udtilzing plaiwelive.

13 Body lbis both radially and axially expandable. Body 10 includes front or distal 4 end 12 snd rea or proximal end 2.,.4As shown- inFIG, 1A,.end 12:has aplurality of closed i structures. These closed structures may be small closed loops 6 or bends. 8 (FIG, IB).

16 Both bends 8 and small closed loops 6 may be formed by bending a wire 5 at a selected 17 point located 1tweek the ends of w sh aw s cle loops For ta most applications, the selected point of the bnd or'm l cl loop ay n close to the 19 midpoint of wire 5, as ow in G.1 with, peato Sall closedloop 6, FIG. 1C also shows both cnoso wine5 pgjocat4.proinat end 2 21 remainder of body 10 is not shown). Body 10 is formed by plain weaving wires 5, as will 22 be discussed beldwin 1tail: 2 Loops 6 and bends 8 provide significant advantages, some of WhIch ie 24 unexpected, over woven devices such .the W. that have free wire ends. For 2s instance, the Wallsten patent recognizes that the fre wire ends of the WAU.STIET 26 ,shouldb protected, i4liclytly'a0M6Wlddgingf the pdtetleltiiudid ig daners such f27 Ode arp Wile eids ped. Thd'-Walste pattit suiggstfw;-od by which bne canh 2s attempt to lcasess these dange such a. onnectin jthe-frn wire' ends to each other.by 2 attaching U-shapedmmbert- to them- through Wt eldin gluing or thd lIl 'These -26- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 oe/01 '04 FRI 14:27 FAX 81 2 9810 8200 F B RICE CO. Li3 I suggested methods-can -be -tiine-odumlng- and,- 0 a -result, 'expensive. Nb'such steps 2 need to be takenin creating either loops 6or bends 8B of the -preset woven~ dvices &S Wihl 3 be disdussed beowirr geerdeal, 4 Further, the connections resulting-from the methods. disclosed n the. Wallten s patent aelikely mre proneto mechanical failure than are loops 6, or bends 9f the 6 present woven devices. Far example, welding cap introduce anomalies- imch as gcwks (wch may result from the non-uniform solidifiation, w-ynbonaieec.; ,dor other iuegularities resulting frpM porsty inclusions (wbiPt include sl4g oxides, pgtc.): etc.. into t welded metal that crate stress concenratipa~pdramtcal ira h propensity for the welded connection to fail at those locations.4_ otaste 1i curves and bends resulting in loo'ps 6 and bends 8 am virtually free of any such induced 12 stresses and, ass ~result are ichIeds likey to fal.- 1$ The Wellsre patent alsp suggets luing theS free wvir ends,. a method that 14 Providos e~venl less structural. integit than, can wj i@tprsligbn i1 btwe the jPined wire ends isa only as-" as~esrw si t. een ea 16 the metal usedL Conseuety, th ont created is maze. t alr l84wle 17 joint suffering from the anomalies Just disued isSindlady, the Wallaten patent deisde. first utillzint Wilcitic re sistaknce hbiting to 1 'Wead. together te odits of-crossing 6! -the fwireeisn ntaon the stent and 'then foldithfits wireeii txtazidlnig beond th weded rng ln*ardly ithlight 2) plastic Uefdviati throughconlroled'eatng. This mhd invle n oly, th lkely 22 tductdion: attA4~st lcsc bv hatda resuilt fromW weldfi4it, also ivolves &nadlona itress "Oh the' .joint cratedas "the *to ireedsae i u inardl Whie benj hate. Ths, tis poferM jint i aihilrto thveedjoint- inthat 7 26 Insm egen cuvsadbnehtmyeued tq cet op p bends 27 8 oftepresent woven devicesaprovide dcewith safer ends:, no freewireendsex~t 2* that. may unintentionally penetra~te and d=4ag the wall of the sltnich into which they COMS ID No: SMSI-00564355 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:28 FAX 81 2 9810 8200 ___FBRC o 3 F B RICE CO. 1@ 033 1 tOdivere~d; the bios or loop Gw uhlg Oiey omcnialfi tnarth z fre wre ndsthat Am. connected- togeter- usigwelding or glue;. and' thlkey time- 3 consuming task of creating multiple welded or glued joinrtas~es. no-exdst... ,Further,;whilc, 4 the closed stnzeture 4 (discussed below, in greater detail) may be reinforced using s iitossm lari hde iigge~td-, thb-Walsti pat1i (ie, suc'h as by welding), the a present w~v7i~eic iita'at inost only ba s many poi~nia1 loations for using suich 7 niMod (hii i1i& liklyles te halonsddngfewe wires arm geeal nee or 8 mifiakha ilepresent iteiu than are needed for mi~ng comparably-sized WALLSTB-NTS,.

p oven' e4uatifi.ne,'i of deprestut Wires to two w irev ntbose" are -used in'the to W L tET.A ru lt.thioten ilfrrechnimcal failhure of tho prsentt woven In addition to the foregoing benefits,. loops 6, and bends B also provide advantags over the modified free wire ends disclosed in the Wallsten patent discussed above that are unepeceLFor example, thiventors have foundta th6 msh of'one of the present ~woven sterns may bef-orned'ftom fewer wiresli th .an m thwms ofi a comrejiarably-'sized WAUSETcen eqatn oef the pxnsnt wires totwo wires 'asthol~seareuse din the WALL$TENfI). Accordingly, thie expansile force of one of ie'present wovien sts of'a given size may be maint ed with fewewhtsm-'nw'ould be needto, m''jntaith same expansile force of a WA STN o$saM size, by. *nply increasing the mesh tightis (L incraigageaFG IA-lsusec -below. In greater detail).

SiIry.the inventor have fpundta te;pwrsl rny-t achieved.b Inraig the dimtro thq .presen"t 'vswth o0 r witu .adjustin themeh figln As a reslt th aoun omtal -necd 9 the prou woven strsmayibe less AnW.,hat is !0duction.k innecessary mne4 transltes. to! A. cos s *4pa, a@s deuqibed .aboVe5, alSo means that patients. are less l~ikelyt 2 xciee honbSs noretoo. As, a fanher result, the vadety of sizes tha m~ay be mrated for the present sterns and the vaxiety in- tihe ightessottc wedave of tich is vrAl19" ndiitd lirb f~lfig virually 0;8- COMS ID No: SMBI1-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:28 FAX 81 2 9810 8200 F B RICE CO. 0~034 wuthr thi-nvntos: also.,dzscevend -that virtually no- hortining cus hl 2. bendlpg tho, present -woven steats. .nor do t1he- diameters. of the -present wovei Stewts ncrnim~se 4uriplg h ig.Tlws, it -is easier -to accrately and predictably position the 4 .presen sten4 in a tortuoqs atempy than it. is -topositon -other woven swants that shorte, n s ur or suffer, a-ggr, increaMes in, diameter when bent, such. as ithe 'WALLSTENT. For 6~ P @xmpe.a ihty- pvnprcseintgnt-..=cJlng 10mmein diamner fanned fromn 7 0.006-inch wires may be rptaxinaly 0en by -mpyholding the two ends therof between a tw flitersand ringg thse ed oter, and no shortning or diameter ijncre 9 occurs during mai lbnig, In qlpntrast, for a WA2LLSTENT formed from 24 0.005inch wires, to .behave simailarly, the inven tors found -tha it. should be- 6 cm long and .9 mn 11 In diameter; altogh yyhppmavipu4lated in. a similar manner, .he'WALLSThNT 12 experienced a, 10% incqae in diamete and. sam;g shortening.. Thuis, the. length-toi3 diameter ratios, of the fo~regoing steifs wi 24 and 6.6,repectvely..

14 As ~few as fve wires, aind an uinlimtd'maxiMum number of irsmybuedt is form body 10 for, any. given aplication.. As used heredn, "wirceC will mean a strand 16 formed of any material.sucdh-as metal, plastic, fibr ht II n xq plr ebdmeto at the present- invention, '0 to 12 votes. are typically usd= ofon body 10 in poat.

is applications.

19 Th nwber of w t hinmy -be -used depends on the atpplication, and specifMal on the deSirp expansile foc fst tu.lsep~npi fost of th iets h rda 21 force necemar t redc iledaj:p fti t Foestaffectng the expale forgo' of tie sztout btcud the tightness -of thVeave-(whkisdtrjedbthnu ero 23 wlrsi used end die anzge formzed by tho crossd'Wijra-b umr wres or t closr the 24 anld is to 18OF, tetighter the weae) the6 n~inbor of wirewued to foan the woven stn, ndth dimeero~te~irs wd.Whn boylis used lusecornaryase for 26example, it MAY be desirable to use the smallest possible aMount of wire material to 27 prevent thrombosis and reduce Me possbilty or zestenosi;ll in the voso wIth a relatively 23 slow circulation.

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date (Y-M-cl) 2004-01-09 09/01 '04 FRI 14:29 FAX 51 2 9810 8200 F B RICE CO. [it 03S 2 from about 90 up-to,but'-not including l80 h xpniefcco od 0 itoe a asi angle a1 Approaches I.10. Itisto be umnsto thaC rt nlis. li th.'n Ma1iy: be 4 utilized for angle a. In an exnlary-cinbodiinn angleai is prferaibly'obtuse, more s than 900?,ald mostypeferably abu"50 ncrai pleicnhowever, a lare 6 expansile force may be desirable, and, thus, angle' a may be 'cilee tio f1 such" as'in the 7 case of a utmorous attictuft or tht -like. In tils regad in ani- in -~mm aa study, a 8 stern. according *to the -Prsent nvnonehbtdahigher jxptasile f6rk6 and this' a la9e cpbltofwtsadn-durco reion 1?tWa bbt a' Zaient and' a -WALL.STE -of t. sAam dieer A reveald' in Table. bielw InTale the 11 desigdistinA in the leftmost coluni represents th e cdrcun'rcnti dispcie'j mm) 12 -of the moenth question. Pte&xa9xnpl, aAbof 2 tmi indicates that 'theicrcumferenceo othe 13 stein in question was tiluced by 2mm, -andl thi ocencsarioefetta d4cisplacement was then. recorded. The des] n'V ifr qte A1,T~r a' '.AU 'Sm daM Woven Stemit A ZZ Z W W W Woyen 3miw) Cente Betikeen S i by Ccnt& OvRlp gidc St Side by Side 2 16 13 19 15. 84 4 3 31 $5 9 .22 91 6 _51 4 7 r 42 3 35 16 81 19 62 60 126 .4 167 12- :100 Is216 WZ 4'1 j 115 -84% -170- :63 4 16 127 133 101 100 2 3 1072 165 1-nu 42 12 24 Is 'Wt ie~ 6 jlf nt" o m s used ais a measur of forc.

multiplied by the gravitational constant, t inventors believe that the averge reder will COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:29 FAX 61 2 9810 8200 F B RICE CO. 10036 I chave a better idea abouttthe size -bf.forcc.when the associated mass unit (grams) is- 2 specified... 3 When one uses, cj*, a WAUST3NT or other commercially available stent for 4 stenting, the manufacturer usually repommends to use a stent one mm larger than the s diameter of the vessel, after precise determination of the size of the vessel, to eliminate 6 the magnification factor caused by the fluoroscopy/radlography. This minimal 7 "overtentn' is used to achieve good contact between the stent and the vessel wall. The I manufacturer also typically provides exact data regarding the relationshi between the 9 sten's diameter and length to facilitate precise positioning thereof. The woven nitinol w0 design of the present. invention has significantly greater expansile force than that of the n WALLSTENT if a 90mparable number of wires.are used to form the same caliber stnt 12 (understsnding thatponp wire as used herein andshowa in FIG. IC would require the use 13 of two wires in the WALLSTENT, given the free, unclosed wires thereot). Compared to 14 the WALLSTENT, the closcd,.strucuwes of the stents of the present invention and the Is better shape memory of the.wires that mayb ued may result in a considerable reduction 16 in &6 size of the wires used, in the number of wires u,4 as well as in th angles btween 17 the wits. For intan, i' small vessel applicatiois coronaty artery) it is Is advantageous to use the minimum amount vito (metal) to ndu c the possibility of 39 thr6bosis aiid/dr riestenogis. Furthennore, in preerred embodimenta, angle a may be 2o reduced below 90 degree without losing the necesary expansile force for self anchorig.

21 For the same vascular application, 'the same or eve vreater expaRnsile force can be 22 -achieved ivthi looslely-wovei nitindl design of the present invention compared to de 23 WMISTENT Sid oter available stents. A it of the preent invention may also be s chosen so as to have a diameter 6 ately ten ater tha a of the tubular tnUun to bestepted.

27 Thigle wits enbodiiemii ill rted Gin GV wiehWire ends 7 haiot 29 ben twistS or cuple toinf a d sce 4, a d r b in greatt detal oute version of the sihgli emtinin eis zflunr.i wInIG soA As COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:30 FAX 61 2 9810 8200 F B RICE CO. Z037 illustrated.in FIG..$0A, body 10.of the. stent has an axis 810, distal end 12 and proximal- 2 end 2. First segment 812 of wire 5 is separated from second segment 814 by either bend s 8 (not shown) or closed loop 6. As shown in FIG. O50A, first segment 812 extends 4 helically in a flirst direction around axis 810 toward end 2, and asecond segment 814 S extends helically in a second direction around axis 810 toward end 2. First segment 812 6 crosses second segment 14 in a number of locations 816. As shown in FIG. OA, 7 locations 816 define loo a which touch each other such that the loops are a contiguous. Loops 818 are "contiguous" because, with the exception of the first and last 9 loops, each loop shares a point--location 816-with two other loops.

0to Segments 812 and 814 maybbe ananged in two different ways with reApet US taoh a other..: As shown in FIG. SOA, segment 812 is poitione: farthr from axis 810.than 12 segment 814 a each location 816, while- in MQ-G SOB, segrients 8i12 and 14 .alternate 3 being.futhcr from'axis 810 atmach location 816: IL.wilib nduistoodto those of tsidllin 14 the art, with- the benefit of this disciosu, that segment 812 may be positioned farther 1s from axis'810 than sgnient 814 at one orm6i locptioni816.

16 In the single wire embodimen% of the stents ,n FIGS. BOA and-SOB, loops 818 I n17 reside in a series of planes that includes two groups of planes (not shown), one of which is includes the lp!anes passing through the first. third, fif et. loops 81, and the other of 19 which includes the planes passing tbrough the second, fourth, ixth, etc. loops, 818. The 2o planes in eWt map r ougl y parallel to ecbo..q.

4 e,..Whp body .10 is in its S21 ed state the pla0 in one of tm. groups into.ra tk planes in the other group n at te aO falling within te r ,ge f slightly gmater than 0. to about 450, Axis 810 23 pss" generally thmrugh the cM.r of each of loops 18. 24 As shown in FIG. SOC, certain of loops 818 of th sigle wi' embodiment of body 10 of the stert may be.separed by lonu1 t .dinal s%ge n ,which segments 812 26 and 814 amre twisted. gethe As shown, pairs of, ,nd 9 q loops..818 withh 27 exception the loop located after cose loop 6- are sepaped by twisted segmets a Althpugh nq s.hown, it wiltbe qn4rtood to.th* of a1 n tpart, with th.benet.of 432- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:30 FAX 61 2 9810 8200 F B RICE CO. 16038 I this distlosure, that as many contikiuut loopi as are desired may be sepamted by d 2 twisted segment 820 from another loop, or any other number of contiguous loops to suit a 3 particular application.. For example, three contiguous lops may be separated ftom 4 another loop or two or more other contiguous loops by a twisted segment in the same manner that the pairs of contiguousloops are separated by twisted segments as illustrated 6 in FIG, 50C. Similarly, four contiguous loops may be separated from another loop or 7 two or more other contiguous loops by a twisted segment. As yet another example, a 9 single wire embodiment stent may have only one twisted segment separating two groups 9 of five contiguous loops.

In contrast tothe "hoop stontt.disclosed in U.S. Patent-No. 5.830.229 to Konya at 1 al...("tbc hoop stentf) which is incorporated hered by reference, the single wit; 12 embodiment of the stpnt that has twistedCCsomnt 820, depicted in FIG. 5OC for is 0enmpl.-possesses multiple cpntig0Uus loops a818 As a result; the single wire 14 eznbodimeft stwnts with suchwistpd segmnts arein resistant to forces compressing is loops 818h Ja Isteral manner. Thedirections of such lateral forces are indicated by the 1. larg aw* In FIG, 5OC., As if the single.wit- einbodiment of the stont having 17 multiple contiguous loops, such as the stent depictediiFlG.$OC, is placed in a vessel or is other siructure that is sometimes bent or flexed, that vessel or structure will more likely 19 remain patent when bent flexed than itwo t supported by the hoo steuL to Body 10.of a stunt according to the present invention may be fanmed by various a methods of plain weave including hand weaving and machine weaving. The following 22 process is an exceplary embodiment:of plain weaving according to the present invention.

2 As shown in I'IG14, a templafe$0Ohavipg adiameter corresponding to the chosen 24 diameter of bodyU) Is prvided.- The top -of the template is equipped with holes 302 23 Around its clrcumfrflce. -ins304.ae'placed through th holes such that they extend 26 beyond the outer surace of t emplatc, on oppongsid As shown in FIG. 16; wires V7 5 are bent at about their midpoint around the pins. This bending may result in the 2 fOrWSUOOOi DC a in bboii, or s .os lop fr m 6 -a lop6(not khw) none emobodimo~t of body 1 "ago b of small closed Ioop 6 or COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09

I

09/ni 'o4 FRI 14:39 FAX 81 2 9810 8200 F B RICE CO.

a bed B(P1.1k ma esstha' 90* n me z!ypjcal 'embodimcnVt' 2 ane may beultorgetw thin9Q0 and- mayappwapchA; neut 'intlude 1 ,180-P" In 3 an even More typical cmhodtment,.angl b -may be gkout 1404600; 'Ai ditcassed above, 4 bendx S and lo~ps .41 ar ecreatod in a manner that, makes -them likely;inore 'mechanically s soid tha the oints disclosed'i the. Wallton patent vrcat'y. connecting -two wr 6 .ends togetherthrousb welding atghiing, 7In on ,e embodime~nt ofithe presen plain weaigpo s the ensO wj Wrea S a may beculdtogether and placed around pin 304, instead of bending a sigle wire S as above described. This coupling may be achieved by using any suitable means capable of 1B preven~ing the wire fo restuining zo their straight; .nbent, cofiguratidn.' As shown in 11 FIG. S0t, such means include bending and crimping a mectal clip arond the Wire. -In 12 another embodiment of 'the prtscnt plain, weaving proadas, as. Shown in FJG. NB,'two .13 Wires Smay each 'be,wrapped aro~nd pin;304 separsely mhd-secured using, any iuitable 14 Teang, stych. aw those just descibexd, m fbrther- onitrast to 'bendingt onie wirt 'around pin is304.. Afterannealfing Mating and 'wooling)-zwires'5 shnwni in MIG 3GB as described 16 below, .the two wires -may:ibe couipled to, ech -other'using any bguiable Mahna such; as 1* twistng, crimping or tying as1father below .described.

Is Although onrlytwo pin shown in FG. 6It 1to be drstood th tis.is 19 done for illustrative purposes only, and not to indicate the appropriate number of wires to use. mn any given application. In -an exemplary ciuhdbrient, temnplaeM -i is typvically 21 fqmed of brass or copperi, but may -be formed of .aniy suitable. material capableof 22 withsrnoding the cure teperature below, discussed, Rstainless" lttel Similaty, in 23 an exemplaqy mboment; pins-304 aret tyicaljlneyo tilsssel ai a 24 fonnedzoxy sliMlaly suitable, material. It -is to-te -Understood tha -thb pinsiMy :be supported,. by tbe templa by: dny !autablt mcmant' epablc of-wittanding-the, cure z6 tempexatuu,-including.prefenninkg, atadcpaent-byweldingtadingor the lke.

27 As shown in FIG. 17, after the wires have been bent around the, pins, the wires axe 211 secure~d to the template to prevent them from retuning to their original, strighubent -34a~ 039 COMS ID No: SMBI-00564365 Received by IP Australia: Time (H:rn) 15:21 Date 2004-01-09 09/01 '04 FRI 14:31 FAX 61 2 9810 8200 F B RICE CO.

I position.-This' may be neceswary given the suptrelastic nature of wires.such as nitinol and 2 the like Xdiscussed below). As.shown in FIG. 17, wires 5 are secured by securing wire 3 306 around the outside' of wires 5.so as to secure wires 5 against the outside of the 4 template. In. an exemplary embodiment, copper is typically used for securting wire 306, s but it is to be understood that any sidtable. wire capable of withstanding the annealing 6 temperature of about 500 0 C. discussed below may be used. After the wires are secured, v small weights 360 (shown in FIG. 20) arz attached to thefree ends of the wires Using any 3 -suitable means such: as-tying, or the like. In an. exemplary embodiment, weights with P masses of approximately 50-100 grams may typically be used with wirs having to diameters of between about 0.005 inches and about 0.011 inches. However, it is to be 11 understood that weights of different masses may be chosen so long as the wires are kept 12 under tension straight) during plain weaving (as described below), and prpery 13 balance the central weight (described below).

14 As shown in FI. 18, a stand 330 witha a.circlar plate1320 is provided with an is opening.325. The diameterof the opening may depend -on th diameter of the template.

t In m aoxemplary cmbodiment,. a opening with a diametet .of' about..4.5 cm may be 17 ,typictay utilized in cojunctiowivith a templatcraofa out1.0 cm.it is t be:understood, Is however,.that an opening with a diameter more closely corresponding to the diameter of 19 .the template may be uti0iz. M As shown in FIG.19, before or after the weights iart aached to the ends of wires a 5, the template is inverted. In an exemplary embodiment, the weights may be typically n attaeed to.the fre. ends of the. wires prior to inversion of the templae such that the wires 2a3 kep undertnmi0A and. may ho. prcvented from returning to their unbent nominal 24 sate. A. cntral.weight 348 may:then be 1 attche4 to th endof the template. In an exemplay embo4int the -etral weight may be typieallyp hung 'fom ithe pis.

26 However, it is to be understood that the ceintral weight may be attached to the template's 2 end in any suitaibl manner, such as haging ftm holes in the tdilat. fiself, et -3 5 a 040 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:31 FAX 681 2 9810 8200 F B RICE CO.

[1041 1 ,Before or after central: weight 340.is attached to the cnd of the template,. the- 2 inverted template is placed through openinig-325,as shown in FIG In an exemplary 3 e ebodiment, the central weight may typically be:attached to, th inverted templaterafter 4 the inverted template is placed through opening 325.- As shown in FIG. 20, the wires .may be aranged. fairly evenly around the circumference of the circular plate. As shown 6 in FIG,1,in an.exemplary embodiment of the present invention, 6 wirs:having 12 ends "7 numbind 1-12 (each;wire having 2 ends) are:shown as being arranged in a substantially a .symmetrical fashion around circular plate -320. The weights340 .and 360:typically serve 9 to keep the wirps under tensioniand in balance. Next, the plain weaving may take place, In the manner shown in FIG. 22, the weave may be started by crossing one wire 11 end over the adjacent wire end. This crossing may be made in either a clockwise or 12 counterclockwise fashion. This crossing may be carried out as directed by the arrows .13 shown in FIG. 22. After a complete set of crosses (or one "trnm") has been carried out, 14 the location, of the.crossed wire ends is as shown in FIG. 23. In an exemplary is .embodiment, the resulting location of the wire ends may:be achieved by crossing one wire 16 end over another in. one direction while slightly shifting the wire end not .crossed in the 17 opposite direction. .In an exemplary embodiment, this shifting may be about 15. Thus, is wire end 1 may be crossed in a clockwise direction over wire end 2; while shifting wire ts end 2 about 15° counterclockwise. Once one turn has taken plWstcrossing may begin in the same fashion, but in the opposite direction, as shown in FIG. 24. This process may 21 be repeated until the plain weave is complete.

22 -oTh ti f theltlaiew tlsiaglb at1etween t&ewis FIG. 1A) as may be adjusted by changing the central eight An ihcreas& in the cmtraweightiesults 24 in a looser weave '(decreased 'nl -a between -the wis) aDd vice'versa Upon 2s completonf th plain .weave, th adjacent wie endsiay be dklod a below described.

26 In an exemplary embodiment amording the present inventip.. a conventional 2 braiding machine may be utilized to arrange wiles 5 in a plain weave to farm body 10 of a 28 stent or any other device described herein. Such a braiding machine may be obtained, for 436- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:32 FAX 61 2 9810 8200 F B RICE CO.

I example, from Wardwell Braiding Machine Company in Central Falls, RI. The manner- 2 in, which a plain, weave may be achieved using a conventional braiding machine is 3 displayed in fIG.7 of U.S. Patent No. 5,419,231 to Earle, Il et al (1995), which is 4 hereby expressly incorporated by reference, as well as in FIG. 1 of U.S. Patent No.

5,485,774 to Osborne (1996), which is hereby expressly incorporated by reference.

After the plain weave process is complete, as shown in FIG. 1A, at the rear or 7 proximal end 2 (the end closest to the surgeon/operator) of body 10, wire ends 7 may be a twisted together using .multiple twists:so as to form closed strctures 4, In an exemplary 9 embodiment; as few.at-2 twists may be used, and as many as about 6. In an exemplary embodiment, it is preferable to keep the twisted wire ends as short as possible. The 11 shorter the twisted wire ends are kept, the more resistant to bending the twisted wire ends 12 are. As a result, the twisted wire ends are less likely to be inadvertently displaced during 13is placement, repositioning, or retrieval, thus reducing the potential for causing tissue 14 damage. Although not shown, it wilt be understood to those of ordinary skill in the at is with othe benefit of the present disclosure that the wire ends may be coupled together, 16 instead of by twistiig, using any suitable means capable of withstanding the heating 17 deserbed below, such as bending and crimping a metal clip around the wires, tying them is together with suitable material such as stainless steel wire, welding, etc.

19 Other configurations, of template 300 may also be utilized consistently with the o0 prsmt.disclpsiU. Fqr example, template 300may.be provided not only withpins 304 or 21 tabs 600 (described below), around which wires 5 are-beri wrapped, tied, twisted; erc., 22 prior to weaving the body of the stcnt (or the bodies of any of the woven smtuctures 2$ discloi herein), tbift may also be provided with pns around which the wJr ends may be a4 twistedin fashioniiclosc 4.Finish pns800 may be suppied on a ing such 2 as rng 802 dpicted n 4in any ble shion, including, for example through 26 reihovablc or permanent attachmenL Ring 802 miy be configured to threadably engage 27 template 300 as depicted in FIG, 48. In other embodiments, ring 802 may be configured a to ngag emplate by ~itw f jcionalforces.(not sh wn).or my be equAgmemd to S- secure totolato 3p0 swould a clamp (pt hon ),Finish pin SOQay also e ai-37- Q 042 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:32 FAX 61 2 9810 8200 F B RICE CO.

i .engaged with template 300 in the- same manner as:pins 304. As-shownin FIC. 49, in- 2 such an.embodiment, twmplate 300 may be provided With finish holes 804 similar to holes 3 302, and finish pins 800 may be plgacd through finish holes' 804. Ring 802 may also be 4 utilized in place of holes 302 and pins 304. s In an embodiment in which finish pins 800 are engaged with template 300 through 6 the utiliZation of ring 802, the number of finish pins utilized may be equal to the number 7 of wires 5 that are used.. Template 300 may be threaded along any portion of its length so a as to. best.accommqdate a varioty of woven body sizes. For example, only a portion of 9 template 300 may be threaded as depicted in FIG 49. Threads need not be utilized with aring that engages templat300 by virtue of frictional foaces. 11 Advantageously, the use of ring 802 allows for the easy and precise alignment of 12 pins 304 or tabs 600 with finish pins 800. Another advantage afforded by the use of ring 13 802 is the ease with which the precise length of the woven body may be achieved. The 14 length of the woven body may be achieved by adjqsting and fixing the distance along the length of template 300 between pins 304 or.tabs 600 and finish pins 800..1 an 16 embodiment in which finish pins 800 are placed through .finish holes 804, the number of n7 finish pins utilized may be equal to one-half of the number of wires 5 that are used, pince is both ends of the finish pins will be utilized. Template 300 may be provided with finish 19 holes 804 along any portion of its length so as to best accmmodate a Variety of woven body sizes. For example, only: a portion.of template 300 may be provided with'finiih 21 holes 804, as depicted n flG 49.

22 As with n 802, the se of finish holes 804 advanaously allow for the easy as and precise alignment of pins 304 or tabs 600 with finish pins 800. Aditionallythe 24 precise length of the woven body may advantageously be achieved by viztue o the as distance along the length of template 300 between pins 304 or tabs 600 and finish holes 2 804 (and, therefore, finish pins 800,) 27 With fifish pins 800i place, ond the, we f w, s 5 ve n 2s around template 300, the ire ads may be cued iround fiish pin. 800 in any shitable -38- 1043 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:33 FAX 61 2 9810 8200 F B RICE CO. I044 I manner to form closed structures 4, ifncluding by twisting, bending, wrapping and the like." 2 In .one embodiment, the.wime ends-may be crossed, then bent around. finish pins 800 and 3 then secured together using a short.piece of a thin-walled 'tntal tubing. Such a joint may 4 then be reinforced by soldering, welding, or the -likei, A suitable nuniber. of additional twists may be utilized after securing .the wih ends around finish pins 800 in forming 6 closed structures 4. Securing wire 306 (not. shown) may be utilized to secure closed 7 structures 4 to template 390 during annealing. 8 As a result of securing the wire ends around finish pins 800, the angle created 9 between the crossed wire ends may be similar, if not identical to, angle b described 1o .above. Advantageously, by-using finish pinas.00; this angle between the crossed wire it ends may be maintained preventing the weave of thewoven body from loosening. Were 12 loosening to occu, the expansile. or radial force of the portion of the body with the 13 loosened weave could decrease, causing that portion of the woven body to remain 14 elongated within the structure in which it is placed. Therefore, through the use of finish is pins 800 and as a result of the correlating maintenance of the angle between the. crossed 16 wire ends that are wrapped or twisted around the finish pins, the tightness of the weave 11 along the length of the woven body from end to end may be consistent and resistant to is loosening, and the expansile foice of the end of the woven body having closed structures 19 4 May be comparable to the expansile force of the other portions of the woven body.

Another method of creating body 10 of a stent according to the present invention 21 is illustrated in FIGS. 37T474. As shown. in. G. 37, the base of template 300 may be 2 equipped .with longitudinal tabs 600 formed by two. longitudinal. cuts connected by a 3 transverse cut. pT length of the qut, may:-be de'ermined based upon. the size. of the 24 tezmplat.. choen. For example, a..toplatc that is,about 10 am in diameter may have lOngitdl .u-i tas: with onitudinalct au t 4 .ato. 5 ong, and the connecting a t Iwverpe cuts nay be about 2. mp long. As illustrt$d in FIGS. 37, tabs 600. may be 27 slightly elevatd from the surfaceoftemplaW 300Q nd may.blpositipond equally around a -3P-.

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:33 FAX 61 2 9810 8200 F B RICE CO.

I FIGS. 37 and 38A and B also illustrate that wires 5 may be bent aroundtabs 600"' z at selected points: located between the ends of the wires to form bent portiofis along wires 3 .The bent portions may take the form of bends 8, as shown in FIG. 38A, or may be a further wrapped around tabs 600 to form loops 6, as shown in FIG. 38B. Angle b of bends 8 or loops 6 may be less than 90°. In a more typical embodiment of body 10, angle 6 b may be equal to or greater than 90, and may approach but not include, 180. mThe bent 7 portions may be arranged to define end 12.of body 10. Wire ends 7 of wires 5 may then a be weaved to create body 10 using, for example, the following machine weave method.

9 .As, shown in FIG. 39, ends 7 of each wire 5 mdy be:arafiged around a pair of bobbins 602. The length of: the wire wound around eachbobbin may be determined by 11 considering..the total length of the wire needed to form: body 10 Si tell as the wire length 12 needed to arrange the bobbins aroind weaving plates (shown in FIG. 40), which are 13 discussed below in greater detail. 14 As shown in FIG. 40, in one embodiment in which bobbins 602 are utilized, two is coaxially arranged weaving plates may be utilized. As shown in FI.G..41, upper weaving is plate 604 and lower weaving plate 606 may be positioned in different horizontal planes.

17 FIG. 41 illustrates that the weaving plates may be equipped with multiple bobbin rods S 608, the axes of which are substantially perpendicular to the weaving plates, on wich 19 bobbins 602 may be slidably secured. (FIG. 41 depicts only 4 bobbins for the sake of simplicity.) The weaving plates may be provided with' holes therein through which 21 template 300 and/or wires 5 may pas, .as shown in FId;"4. Template 300 may be 22 secured to the base of the weaving machine chosii using any suitable means such as 23 template.rod 610, around which template 300 may pass. a. shwn in FIG. 41. Template u 300 may be.secured to the' base bf the waviing machine chosen ising any sitable- mean 2s such as template rod 610, around which template 300 iay be slidably placed (PIG 3.

26 Template rod 610 may be configured to firmly engage template 300 through frictional n forces by tapering template rod 6i0). Instead of tmnplte' rod El6, any appropriate a lock mechanism may be used to secure the base of the weaving machine to teimplate 300.

L1045 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:34 FAX 61 2 9810 8200 F B RICE CO.

Z 046 As shown in FIGS. 42A and 43A, the.pairs of bobbins.602 may be prepared-for- 2 weaving by arranging one bobbin on upper weaving plate 604 and the other bobbin from 3 the pair on lower weaving plate 606. Wires S may then be beni around tabs 600, and the 4 ends of the wires. may be attached to bobbins 602 using any suitable means capable of s holding wires 5 undertension throughout the weaving.process. An example of such a 6 mechanism is a.cne-way brake that allows bobbin 602 to rotate in a single direction only, 7 .such that the wi.re.:may wind off -bobbin 602; Simultaneously, such a brake may be a configured so as to continuously maintain: tension in. wire 5 by virtue of the brake's 9 resistanceto the winding off of wire As shown in FIG. 42A, with the wire ends in place, th weaving may begin, by 11 crossing the wire ends of the same wire, which results in the formation of a small caliber 12 loop 6 (FIG. 42B) at the site of the bent portion. In another manner of weaving 13 illustrated in FIG. 43,. the wire ends. of differentwires may be tcrssed first, resulting in 14 bend 8 at the site.of th bent portion (FIG. 43B).

is As shown in FIGS. 44-45, the two weaving plates may be arranged such that the t16 .surfaces thereof from which'the bobbin rods.extend face'each other. In this alternative 17 embodiment, the diameters of the plates may be the same or different. Wires 5 may be is arranged on bobbins 602 in the same manner as described above, as shown in FIG. 19 Despite which of the aforementioned weaving plate arrangements is utilized, the weaving plates rotate in opposite directions during the weaving process. The weaving 21 plates may be operated at any suitable speed. In this regard, a speed as low as 1 to 22 cycles per minute is acceptable. The weaving plates may also be driven by hand.

23 The weaving plates may supponed and rotated'using any suitable means. FIG. 61 24 illustrates.bne means of supporting and rotating weavitig plites 604 and 606; (FIG. 61 2s depicts on 4 bobbins for the sake of ibplioity.) As shown, weaving plate supportr 650 26 mnaybe equippedwith.lowerarm652 ad pe arm654 forsuppoting lower adupper 27 weaving plates 606 and 604. respectively. Weaving plate drivern "0 may be'secured to.

.2s the upper and lower arms of the weaving plate supporter and engaged with the weaving -41- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:34 FAX 61 2 9810 8200 F B RICE CO.

1047

:Y-

I -plates in order to pperateithcm. The-uiveis may beco figuredto operate in any suitable-- 2 fashion. For example, the drives may be configured with a power- surce and provided 3 with gears of any suitable configuration for causing the weaving plates to rotate. The 4 d.ivers may also be configured, to utilize magnetism or electromagnetism -to rotate the s weaving plates; The drivers may be also be configured such that the weaving plates may 6 be rotated by hand. Further; although, not shown, it will: be understobd to those of skill in the art, with the benefit.of this disclosure, that eitlher or both ofthe upper and lower arms s may be provided .with: brandhes to which drivers may .be attached. The drivets or the 9 branches could then be secured to or engaged with the top surfaces of the weaving plates it in the same fashion that drivers 660 are engaged with the bottom surfaces of the weaving w 6 ,s 11 plates as shown if FIG. 61. Thus, in such an embodiment, both the top and bottom 12 surfaces of each weaving plate would be engaged with drivers.

1s A braiding machine suitable: for.carrying the weaving process just described (ie., 14 utilizing the weaving plates) may be obtained, for example, from Wardwell Braiding i Machine Company in Central Falls, RL.

s1 After the weaving .process is complete, wire.ends 7 may be. twistd:together or n coupled as described above to form closed structums 4. To make the process of wire is twisting faster and easier, the.wires may be twisted with a special hand toot designed for 19 this purpose. Tool 612 illustrated in FIG. 46A follows the principle of an automatic 2o pencil. Jaws 614 of tool 611 are configured so that wire ends 7 may be firmly held 21 between jaws 614. Jews 614 may be activated by push button 616 moving against spring 22 618. After placing wie ends I into prfored gap 62 located between jaws 614 (FIG.

23 46B), spring 618 expands (or r 'turns to its unconstrained state) and retracts jaws 614, 24 securing wire ends 7 flmly between jaws 614 de.to the pressuref of uter housing 622 acting to close jaws 614. :Quer housing 62 may thpnbe rotated to create multiple twists 2 of wire ends As illustrated in IG$.47A and 47t, the twisted ends of body 10 may be 27 secured to template 300 using tranve tabs,624,which may be formed the same way as 42.

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09

I

09/01 '04 FRI 14:35 FAX 61 2 9810 8200 F B RICE CO.

Turning to. the single wire embodiment, body 10 may be formed using either the" 2 hand weaving process or the machine weaving process, 'both of which are described 3 above; In preparation for the weaving process, template 300,which nuay be configured to 4 have any suitable shape, may be provided with pin 304 or longitudinal tab 600 near the s end thereof at which. the weaving is to begin. Neat its other end, template 300 may be 6 .provided with finish pin 800 or transverse tab 624, which may be-appropriately aligned 7 with pin 304 or longitudinal tab 600. In one embodiment, finish pin 800nmay be provided 8 on ring 802; 9 The weave of body 10 may then be started by bending wirp 5 around pin 304 or longitudinal tab 600 to form either bend 8 or closed loop 6. In .an excmplary 11 embodiment, securing wire 306 may be utilized to secure bent wire 5 to template 300 as 12 described above.: The two segments of wire S on either side of bend 8 or closed loop 6 13 may then be woven'to create body 10 by helically wrapping the segmentt around template 14 300 in opposite directions toward finish pin 800 or transverse tab 624, The segments may U be crossed over each other during the process in alternating fashion to result in the single ui wire embodiment depicted in FIG. 50B. This weaving may take place either byhand or n using the weaving templates described-bove. is Afr the weaving is complete, in one- mbodiment, .closed structure. 4 may be 19 created by wrapping the wire ends around fiirh pin j00.in the manner described above.

In another embodiment, the wire ends may be .twisted, or coupled togetheras descbed 21 above to form closed structure 4, which may.tten.be secured t transver tab 624. It will 22 be understood that additional pins 304 or longitudinal tabs 600 may beutilize to create 23 the single wire emnbodiment. Such additional pin(s) or tab(s).may be vertically lgged 24 with the other pin or longitudinal tab such that multiple closed loops 6 may be formed at the tad of body 10 ivheretibe Weave begihfs as depicted in fIG.SOB. Similarly, 26 additional jii pinsor transverse tabs tay be utilied i the same fashion. The ise of 27 pin(sy>304 or longituditial. tab(s) 60. t' finish pi 800 or transverse tab 624 will 2* advantageously ensure that wire 5 renains ii position during aneiicalin The- annealing 29 processes dscribed blow may be-utied fr annang tthiengle wire embodient -43- 1048 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:35 FAX 61 2 9810 8200 F B RICE CO.

I After the plain weave of wir is .ompleted on th:template, if the.wires arer 2 made of a material that:,can:be..progra.mmed .with :either thermal shapc- memory or 3 superelasticity such. as nitinol or other shape memory anateriali described below, body S 10ltemplate unit -may tbe heated so as to program body 10 with either thermal shape a memory or superelasticity. If body.. 10 is .programmed with superelasticity, its initial 6 shape can be deformed by applying a brme thereto. After reoval of the force, body 7 may. stAbstantially recover its initial shape. If body 10:is pmgrammed with thermal shape s memory, its initial shape can be deformed upon application of a force at a first 9 temperature. The force may be removed, and body 10 may remain deformed until heated to to a second teinperatue. At the, seconid temperature, body10 may substantially recover I I its initial. shpe.

12 In programming bdy 10 with puperelasticity.,-the .body 10tenplate unit may be is heated to abqut 500S T for about.5 to.15-minutes, typically sbout 12 to 15 minutes, and 14 Ceven more typically for about 15 minutes, in an ovep. Afterallowing the, unit to cool to is room temperature, wires possess superelastic properties. In an exemplary embodiment, 16 natural cooling is typically, used. It is to.be understood, hoWever, that accelerated:cooling 17 using a fluid bath, for example, may be utilized reaulting in slightly different superclastic as charactexristics than are achieved with natural cooling, In programming body 10 with S thenal spe memor, the body 10 late i may e h t to about bC for m about 60 to120 mixiuts, typicua'aboui 120 nhint' i an v. After allowing the iinit 21 to cool to room temberatre, wires S possess thermal shape Memory. in an exemplary 22 embodin't, nttral cooling is typiclly ised. It is to be inder stoo, however, that 23 accelerated codling sing a fluid bat, fo exmnple, my utiliize resulting in slighdy 24 different thertiial shape memory Cfiii i' than 'i achieved w ithtuM cooling 2s In an exemplary embodiment of body 1-0, it-is.preferable to further reinforce the 26 coupled. wire ends of. plosed stmucture 4 after body 1.0 has .been !ppery al~ 2 (especially if .twisting was utili Thius rfinfo m :.way be -aComplished :hy. any 2 suital means such as point, welding, sodering, p ress .welding,.,or th like& The ir n ends of closed structures 4 may be sol lred by removing any: oxide layer .that may.have -44l1 049 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:36 FAX 61 2 9810 8200 F B RICE CO.

Sfonred over the relevant portions of the wires used, and applying solder to those potions.

2 Soldering may be :enhaiced by first wrappizi'g the "coupled wire ends of the closed 3 structures 4 with thin stainless steel wires. In an ex'emplary embodiment, point welding is 4 preferred to soldering; because point welding is easier to perform than soldering, anid may 3 be more suitable with igard-to long-term implantatioti of the stent.

6 The wires of body 10 may be constructed.of any material compatible with the 7 tissue in which the steit will b placed. Furtth, the mat.,rialmay be suitably rigid and Selastic and capable of being p sranWed with .either superclasticity or thermal shape 9 memory. The materials nay, for example, be NiTi alloys like nitinol. Such alloys can be i0 heated and allowed to cool to room temperattm, resulting in the alloys. having either 11 superelastic or thermal shape memory properties, depending on the heating time as above 12 described. Other alloys that may biuised include FePt. VPd. and FeNICoTi. These 1 alloys may be heat. treated to exhibit thermoclastic matensitic transformation, and, 14 therefore, good thermal shape memory. Other alloys such as FeNiC, FeMnSi, and is FeMnSiCrNl do not possess long-range order and undergo nonthermoolastic i6 .transformation, and, hus, may also be used. Additional. some j-Ti alloys and iron- 17 based alloys may also be used., Is In an exemplaty embodiment, nitinol possessing about 55 to 56 Nickel, and 19 to 44 Ttanium, may be used for wirhes 5 of body 10. Such bitinol wires are comme~ally available from Shape Memry Applications in Santa Clar CA.

21 8Wbea using intino wiw, th6itdiophcity ofbody 10 advantageoisly increases 22 over the radiopadity of stenti forIed using a l such a itainless steel. The radopcity depends m•ilj .n th diinetsr of the itinol wir k and the ttness of t.

4 lai wtvri criated by th wire The rdopacity of bdy 10 c beincreased further by 2 using silver solder to reinforce the coupled wire ends forming closed strucres 4.

bwire sizes tht iay be used for t sents of the pisen inv ation vary S depeddng'on the aplio ai of t"he Ina enxeminary embo t, sll stets rar ng from tboC;' o about 4 uija in diamete nd" ibout to .bogtZ5 cut in l ,gtb.

a 050 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:36 FAX 61 2 9810 8200 F B RICE CO.

I typically for coronary appicaion,may utilize wires frm, about 0.0403. to, about 0.006-- 2 inches in diameter. In-an exemplary embodiment, medium stents ranging from about 3 to about 10 mm in.diameter and about 2 to about 10 cm in length, such as are used in the 4 iliac artery, femoro-popliteal artezy,.carotld artery, and the renal artery, may utilize wires s from about 0.006 to about 0.009.inches in diameter. In an exemplary embodjpment, large 6 stents above about 10 mm in diameter may utilize wires from aboat 0.006 to about 0.012 7 inches in Wfanter. Applications for th6 laigo stens includ the aorta (typically a vessel I diameter in about the 20. to 40 inM' rige), the infetior vena cava which is 9 usually leis thin -bout 28 ruin diamer, the 4 superior von "cafl ('SVY the esophageal (20-25 mm i diameter), -and the .6lot, which my be about 15 to abotit is 12 apered Stat is With referece to the illustrative embodiment shown in FIG. 14, there is shown a 14 tapered st for iinsertion and deii !ey into an ainatomicasl :tsructur. Tapered body 100 may be formed using plain weaVe by the etods aboe bed. ential 1' embodiments f tapered'body 100 include the sgle wie em types of 17 applications for which a tapered stent may be used inclu'de the ill n-femoral, feioirois popliteal arteries, as well as in the qgarctid arteries for stepting long .Slesions.

19 The taored configuration may be achieved difrnt ways. In a :f t method using the hand weave Iiethod or any of the inaehine methods d bed above, a template may a be chosen possessing an.appropate taper. In an exemplary embodiment, a template with as a smooth, contiguously decreasingdiamter without steps is typelly used. The shape of a the template may conpespond roughly to the inner shape of the taperedstt. The shape of ,2 th .MP ma P pe of th....edte U the tapered stent may be chosen based on the shape of the yessel or structure into which it will be placd.

26 In an exemplary embodiment, it may be preferable to choose a shape for the tapered stent (and,.thus, for the erplate) such that a "wedge-effect" will be achieved 28 between the tapered sltent and the-yess l or structure into which it is. placed. The wedg- -46a051 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:36 FAX 61 2 9810 8200 F B RICE CO.

x effect may be used to fix the stent inrposition and prevent it from distal migration. It is to- 2 be understood, however, that any suitable means for improving the fixation of the stent in 3 the, vessel or structure, such as flaring the proxinal end of the stent, may be used in 4 addition to or instead of the wedge-effect.

Using such a template and either hand or machine weave, the weave may be 6 substantially:uniforn along the axial length of the stent As a resuit of the substantially 7 .uniform weave, the expansile force 6f the stent may be substantially uniform along the a axial length of the stent. Although the expansile force may be substantially uniform as 9 stated, the match between:the diameters of the tapered stent and the vessel into which the to stent is. placed may rsult in the vessel being exposed to a force lesser than would be n .exhibited by a straight stent..

12 In another embodiment according to the present invention, a template possessing a 13s uniform diameter as described above may be chosen for use with either the hand weave 14 method or a machine method. The diameter of this template may correspond to the is diameter of the largest portion of the stent. Tapered body 100 may be woven around this 16 template and heated and cooled as above described. The wire ends of closed structures 17 104 may then.be reinforced as needed for the application. Tapered body 100 may then be Is mounted on a tapered templre in a fashion. similar to the on edesoribed above using 19 a copper wire), and irheated in a manner similpr to the original heating. Forming the 31 stem in this manner results in a contiguously loosening mesh toward the tapered end of 21 the stent. That is, angle a is contiguously decreased toward the distal end 102 of tapered 3 body 100 resulting in a decreasing expansile force ofte tapered stent towards the tapered 23 distal end 102.

24 It is to be understood that if a stent (or any other device disclosed herein) is rmodeled a number of times and it is not intended that the sent be programmed with Sthe shampe ne ry, are should 6. taken not to exceed a total heating time (which 27 includes the first hating time and the secon heating time, etc.) of about 60 minutes, 2 beca atabb0 minnutostt i ma be programmed h"th enal shape' memory.

1052 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:37 FAX 61 2 9810 8200 F B RICE CO.

i As with body 10, one or more of the coupled wiro ends of .tapered body 100 may- 2 be .left slightly longer than the others and.bent ioward so as to allow for retrieval of the 3 stent using a foreign body retrieval device. .Further, closed structures 104 of body 100 4 may be flared to improve stent fixation.

3 I1 an in vitro study, the expansile force of the tapered stent of the present 6 invention was found to be proportional to the weave tightness. .The.results of this study 7 are set forth below in Table 2. The tightness of the weave is strongly associated with the a angle between the.crossing wires.gs well as with,the number .of wires used for. creating the 9 weave. The.stents used in the study were built from 0.011:.inch nitinol wires. If the angles between the crossing wires are wide (closer to 1S0)}, the stent is better able to 11 withstand any outer compression. An increase in the diameter of the nitinot wire would 12 increase the expansile force of the stent.

13 Table 2 Taper-Shaped Self-Expanding Repositionable 14 Stent Comparative Study. Using 0.011" Diameter Wires SA 10 8 Wires 6Wires, 6 Wires, (nnmm) Wires,. Moderate Loose Tight Tight Weave Weave Weave Weave S .2 :115 9.1. 26 92, 4 176 123 55 103 6 208 141 74 119 8 :238 158 92 126 273 t70 103. 136, 12 293 186 120 145 14 331 202 129 1'53 16 371 223 146 171 I With respect to Table 2, thbe inventors used the unit for "grams" as the n measure of force for the reasons discussed above. Similatly, the designation A.in the t leftmost column of Table 2 represents the circumferential displacement (in mm) of the 19 $tent in question. For example, a A of 2 mm indicates that the circumference of the snt -48- S053 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:37 FAX 61 2 9810 8200 F B RICE CO.

F

1 in question was reduced by 2 mm,,and the force necessary to effect-that displacement was- 2 then recorded.

3 Advantages of the tapered stent of the present invention include superb flexibility, 4 repositionability and removability, precise positionability, and, better matching than a cylindrical stent with a uniform diameter between the tapered vessel and the stent which 6 may result in less intirx reaction and longer vessel. patency.

7 Covered Stents a Various material may be" suitably used as grafts (including materials used as 9 covers and those used as liners) that may be attached to the present woven stents so as'to create stent grafts. One type of covering material that may be utilized for this purpose is 11 made from material that is stretchable enough to substantially fbllow the movement of the 12 stent's mesh. This type .of graft material includes woven-polyester, Dacron, polyurethane 1a and the like. Depending on.-the application, the graft material may, for example, be 14 somewhat porous (to.facilitate endothelial inigrowth), highly porous (to leave bridged side 1s branches patent) or non-porous tO exclude an anourysih or fistula from circulation, 16 or in another application to prventtumo ingrovth into the stent graft lumen).

17 The graft material may be attached to either the outer or the inner surface of the it stent, so as to serve as a cover or a liner, respectively. The graft material may be attached 19 to the stent using monofilament sutures polypropylene such a 5-0, 6-0, 7-0 Prolee, which is commercially available from .hin glue heat. or any other appropriate 21 means.

22 Graft materials that are not stretchable or elastic may also be utilized to form stent 23 grafts. One such material is FIPE. Such graft material may be attached to only one of n2 the stent nds, thereby allowing free movement of. the wire mesh. The attahwment 2 between the stent and'the graft material may be created at the proinmal end of the 26 resulting stent graft (that is, the end of thistent-that will be closest to the operator).

I1 054 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:46 FAX 81 2 9810 8200 F B RICE CO. IM074 1 Such a stent graft:may beprcloadedintb an appropriately-sized heath. 'Thegraft- 2 material may be folded or arranged so that it occupies as little space within the theath'as 3 possible.

4 Delivering a stent graft having a graft material made from a relatively; nons stretchable material such asPTFE may be perfonnedin a mafnner that is different than.the .6 manner in which a stent graft having a.stretchable ,graft materialmmay be delivered. For 7 example, with a stent graft having a cover made from relatively non-stCrtchable graft a material, after the stent graft is positioned as described below in greater detail. the sheath 9 may be retracted and the graft material may therebybe exposed. Then the stent may be allowed to assume its unconstrained diameter by using the coaxial delivery system. The 11 fact. .that the coaxial delivery system enables to achieve a more compressed mesh 12 tightness than that achievable by allowing. the stent to recover, may .be .advantageous to .1 create an adequate contact between both the.stent and the. gaft as well as between.the 14 stent graft and the vessel .wall,. The different -deliverymechanism. requires .a different s approach to stent graft retrievl. First, the stent Is completely. restretched over the 16 delivery tubes and the stent's completely elongated position is secured by. the proximal 17 lock mechanism. Second, the sheath is advanced. preferably using some rotating Is movement to recapture the graft material. The creation of the attachment site between the to steat and the graft at the proximal d of the 'tern is advantageous for possible *o repositioning. The stent's proximal end is secured io the outer delivery tubs, and the S graft to the proximal end of the stent, therefore, the proximal portion of the graft is 22 formied into a finnel shape facilitating its retrieval into the sheath.

3 SWideBy-Se Stent Placement in Aeorta and Bateram Renal Artery 24 The present stent.may be delivred in a variety of anatomical structures. Further.

S -they may,b used in conjunction with each other in a variety of manners to beat treatthe 26 diseased structure. For.example, asshown in FIG. 54, the bilateral aorto-renal junction 2 830. consisting of aorta 832, .left tnal-artery 834 and right renal artery $36, along with a the orto-iliac junction 840, consisting of left iliac artery 842 and right liac artery 844, 9 may be treated using uses two stems positioned in side-by-side relationship with each COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:47 FAX 61 2 9810 8200 F B RICE CO. 1075 I other. Alternatively, stent grafts shorter in. length than 'those shown in FIG, 54 may be- I2 delivered within the aorta or. the aorto-iliac junctions with some overlap therebetween.

The stents that may be utilized may be woven and annealed as described above on 4 a variety of templates. In one embodiment, straight templates may be used. The stents s may also be woven and annealed as described above so as to be relatively tapered, such as 6 those in FIG. 54. In such a configuration, the portions of the stents that will occupy the 7 aorta may be larger in caliber than those portions of the stents that will olCupy the renal a arteries. The stents may also be woven on templates that are configured with a bend that 9 may approximate or match the angle. between the appropriate renal artery and the aorta.

Stents that may be partially or completely provided covered or lined) with 1i any of the graft materials described above using any of the methods of connection 12 described above may be used in this application. In the embodiment of the pair of stents 13 illustrated in FIG. 55, the portions of the stents that occupy aorta 832 and portions of the 14 stents proximate the caudad Surfaces 838 of renal arteries 834 and 836 .are covered. By is only partially covering the portions of the stemas that will occupy renal arteries 834 and 11 836, the possibility of endoleak-from. the renal arteries may be greatly reduced or 17 eliminated.

n In another possible embodiment suitable for this application illustrated in FIG.

19 56,.the aortoenal stent, may include, stuts 850 that may be fomnned by twisting neighboring segments of wires 5. during the. weaving process. Atrus S40'may also be 21 formed in any suitable manner such as by encasing neighboing segments of wires S in 22 flexible tubes, such as those made of nitinol, or by soldering or welding neighboring .23 segments of wires 5 together, etc. As used herein, "strts" means segments of wires that 24 are joined together in any suitable manner such as twisting, encasing within a sufficiently flexible piece of tubing, solderng, welding, etc., such that the portion of the stent formed 26 from the strt is less disruptive of the blood flow threthroogh than would be the same 27 portion formed from a weave. The stent graft having struts 850 may, like the stent grafts z2 depicted in FIG. 55, be covered partially with any suitable graftmaterial, such as those S relatively stretchable materials disclosed above. Acordingly, the portions sunounding -51- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:47 FAX 61 2 9810 8200 F B RICE CO.

I .:struts 850. r y be coveCred while leaving struts850 uneovremtd:andtherefearanged so-- 2 that when delive.wd r.as shown in FIG..56, struts S0are advntagsously positoned'v in 3 the vasculature with regard to hemodynamics. The use of struts 850 in this fashion may 4 be advantageous In copriso to leaving a similar roftion of the stent utilized simply s bare, as in FIG. 55, in that struts 80 would be less likely to create turbulence in the blood flow.

7 In one embodiment of the stont graft illustrated in FIG. SG haiving struts 850, differ.ent portions of the sentmay be provided with diffcrent numbers of wir. Tunilg 9 to such a stent, the weave may begin at the end of the-staent that will be placid in the renal 0so artery and made be made from n wires. The portion of the stet occupied by stts 850 1i may also be made from n wires. The larger portion of the "stat that will occupy the aorta 12 may use n+x wires, whe x denotes the number of additional wires utilized, and may be 1s between 1 and 2n. Pleferably, x is selected from an integer between 2 and n, and more ,4 preferably x equals ni. the teniplate on which this type of steit is formed may have pins 304 positioned, for example, at locations proximate the end and beginning of struts 850.

6 Bdqwdable Devices 17 Both the straight and the tapered atents of the present invention (as well as the is filtprs and opeluders dissed below), except for the. single- wire, umbodiments of these t19 devices, may be formed with filaments made of biodegradable mateial so as to form self o expanding, bioabsorbanble. biodegradable stcnts that may, in addition to:funtioning as 21 tents, function axdrug or nutriept delivery system as-armlt of thematerial used.cL 22 Many factors may be considered in choosing materials from which to form the S biodegradable stenA ofthe present invention. In one embodiment, the biodegradable 24 sterns of the present invention may be formed from materials of minimal. thickness so as 7s to inimize flood flow blockage and facilitate bioabsortion. In another embodiment, 2 te material may be chosen so as to exhibit suffcient radial stegth to allow the body 27 formed to fimction as a stet. The material from which the biodegradable stents my be 2 formed may also degrade within the bloodstream over a period of weeks or months, so as -52- 0076 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:48 FAX 61 2 9810 8200 F B RICE CO. 1077 S .nop to form emboji. .The material -ay-be. chosensuch: that the stent does not degradebefor .an endothelial, layer forms in the stentpd vessel or structure in cases in which 3 stenosed aortoliac arteries: with lengthy affected segments :ate treated. The. material 4 .chosen may be chose. to be compatible with surrounding tissue in the vessel as well as s with blod. 6 The body of a biodegradable stent may be formed by plain weave using the 7 methods above described. The size of the filaments used may vary .according to the 8 application. In some embodiments, the filaments may be reduced in size in comparison 9. to the size of wires used in comparable applications involving non-biodegradable devices.

In other embodiments, the number of.filaments used may be increased in comparison to ,I the. number.of wires used in comparable applications involving non-biodegradable 12 devices, 13 The minimum number of filaments that may be used to create the body of a 14 biodegradable device (including stents, occluders and filters) may be about 5. In one embodiment, 12 filaments may be used. With regard to stents, in creating the body using a6 plain weave, the angle of the crossed filaments (described above as angle a) may vary as 17 described above, but is typically iS-1lo6. In one embodiment, the angle of the crossed Is filaments may be as large as possible to achieve the largest radial fore possible and 19 further ensure that the stent may have enough expansile force to remain in place after o being delivered. The filament ends, after plain weaving is complete. may be coupled 21 together to form closed structures using any suitable means such as by heat treatment or 22 sealing, gluing, tying, twisting, crimping, taping, or the like. In another embodiment, a 23 long body may be woven, and the body may be cut. into tubular segntts. Closed sp.ct.res.may be formed at bth ends of the segmented bodies by coupling the.filament nds together ,as above desribed. 2 In one embodiment, the filaments used may be made of polyg olic acid 27 V(GA", poly-L-lactic acid polyorthoesters, polyanhydrides, 2 polyiminocaronates, or inorganic phosphates These polymers are commercially 29 available from United States Surgical Corporation, Norwalk, CT; Birmingham Polymers, -53- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:48 FAX 61 2 9810 8200 F B RICE CO. El078 i .IInc., Birmingham, and .Ethicon. -Sonnerville. NJ, for example. One factbr to-.

2 consider in choosing a material from which to make the filament will be the god of the 3 stent placement. For example, in an embodim6nt in which the stent serves mainly as.

4 dSug delivery system, PLA may be used because of its rapid degradation time; In another s embodiment in which the stent serves mainly to maintain the patency of the vessel (Le., 6 keeping the vessel open) and as a scaffold or frame for the development of a noew 7 endothelial layer, PGA may be used considering its high strength and Stiffness. In other a embodiments, glycolide may be copolymerized with other monomers to reduce the 9 siffiess of the resulting fibers that may be used.

.In another embodiment, any of these filaments may be provided with about 0.05 u to 0.25 percent by weight of a basic metal compound, such as cilcium oxide, calcium 12 hydroxide, calcium carbonate, calcium phosphate, magnesium oxide, nmagnesium .13 hydroxide, magnesium carbonate, magnesium phosphate, sodium phosphate, potassium 4 sulfate or the like, to increase the M vivo strength retention of the biodegradable stent by 1i about ten to twenty percent or more, as described in U.S. Patent No. 5.478355 to Muth 16 et at which is hereby expressly incorporated by reference. As used herein, "in 17 vivo strength retention" refers to the ability of a biodegradable body to retain its strength is the breakiig load of the body) after being implanted or delivered into a living 19 creature. In yet another embodiment a filament obtained from a polymer containing about 15 to about 30 mole percent glycolide in a meit spinning operation, as described in 21 U.S. Patent No. 5.425,984 to Kennedy sta (1995), which is hereby expressly 22 incorporated by reference, maybe used tb foma blodegralabe body.

2 The filaments of the biodegradable devices may incorporate one or mo6r drugs U4 that positively affect' .healing at: the location where the stent is delivered. In one embodiment, these drugs may include anticancer drugs such as paclitaxel (which is S commercially available as TAXOL, from Bristol-Myers Squibb in Princeton, NJ) or 27 docetaxel'(which is commercially available as TAXOTERE, from Phone-Poulenc Rorer 28 in Collegevile, PA), fibroblast/smooth muscle cell proliferation-prvnn g agents, and -54- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:49 FAX 61 2 9810 8200 F B RICE CO. 079 I antithrombogenic drugs: such as hepain .which is commercially available from Wyeth- 2 Ayers in Philadelphia, PA.

3 One or more drugs may be incorporated into a polymer using any suitable means.

4 For example, in one embodiment, the drugs as a solute may be dissolved in the s biodegradable polymor as a solvent to form a solution. The solution may then be 6 hardened into a fiber from which the stent may be woven. In another embodiment, 7 simple mixing or solubilizing with polymer solutions may be utilized. The drugs may a also be dispersed into the biodegradable polymer during an extrusion or melt spinning 9 process. In yet ,another embodiment, -the biodegradable fibers that have already been to formed-may be coated with drugs.

u The biodegradable filaments may be rendered radiopaque to facilitate their 12 monitoring under fluoroscopy and/or their follow-up using. radiographs, fluoroscopy, or 13 computerized tomography. The methods described above for incorporating the drugs into 14 the polymer may be used to mix radiopaque salts, such as tantalum, with the polymer.

is -As used herein, "degradation time" refers to the time during which the 16 biodegradablo .device maintains its mechanical integrity, One factor that should be 17 considered in choosing a polymer in light of its degradation time is that the polymer will i loose. its mechanical integrity before it is. completely absorbed into the body.-- For 19 example, pure polyglycolide (PGA) sutures los& about 5b% of their strength after 2 o weeks, and 100% at 4 weeks, and are completely absorbed in 4-6 months. Por vascular 21 applications applications in which the stent is placed within a vessel in a body), 22 polymers having degradation times of: about one to twenty-four months may be used, a depending on the application. In a. typical embodiment; a polymer having a degradation u time of about one to thie.months may be used. In choosing a polymer for non-va:cular a, applications such as th.esophagus, colon,. biliary tree, tmreer, etc., one should consider 2 the pplyer ~ahbility:to withstand the chemical.stimuli in the given environment 27 Durin the degradation time of a biodegradable stent, a new endothelial layer may a form on the surface of the snt. The rate of the release of the drugs which may be COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:49 FAX 61 2 9810 8200 F B RICE CO. [080 I incorporated into the polyrners may be controlled by thw rate of degradatio of the- 2 biodegradable material used. Thus, the rate of release of a. dtug may act as a control 3 quantity for the rate of degradation. At the same time, other agents such as fibronectin 4 from human plasma'(commerifially available from Sigma, St. Louis, MO) may be added s to the polymer used (using any suitable means described above for incorporating drugs 6 into the chosen polymer) and may affect the rate of biodegradation. For example.

7 fibrodicctin may accelerate the growth of cells around the surrounding astem, which, in a turn may accelerate the resorption actions aroand the stet.

9 In one embodiment of a. biodegradable body .acording to the present invention, to one or more shape memory wires may be added to the body for reinforcement"aft6r it is 11 formed using plain weave. Such wires may comprise nitinol or any other comparable 12 material above described. In one embodiment, the wires may be formed from nitiool 13 having about 55 to 56% Nickel and 45 to 44% Titanium (Shape Memory Applications).

14 The wire or wires may be incorporated into the woven biodegradable body by threading is the wire in and out W, openings in the body several times. In one embodiment, the i manner in which the wire is threaded in and out of openings in the body is shown in n FIG. 31. In FIG. 31. designation 520 shows renforcement wire 510 passing outside is biodegradable body. 500, and.designation 530 .shows reinforcement wire 510 passing 19 inside biodegradable body 500, thus showing how wire 510 may.b threaded in and out of 2o openings in body 500. As shown.in FIG. 31, the reinforcement wire(s) 510 may be led 21 between parallel to) twobiodegradable filaments 540 and may follow their helical 22 course. As shown in FIG. 31,.rinforcement wire.510 may be secured to body 500 with 23 loops 550, or any other suitable means such as tying, twisting, or the like. Loops 550 may 24 be placed, around. a filament or. around the intersection of one. or more filaments. As a.

2s result, the wire can move in harmony with the weave and will not interfere with the 26 movement of the filaments in the weave By ativating the -superelasticity or thermal 27 shape memory.of reinforcement wire 510, ends 560 and.570 of body 500 may be pulled 2s together, resulting in a tighter weave. As a result, the expansile force of the stent and its a resistance to outer compression may significantly increase. In one embodiment, loops 3o SS0 may also be used in securing body00 to adeivery system.

-56- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:49 FAX 61 2 9810 8200 F B RICE CO. lM081 S In another.:embodiment shown in FIG.; 32; in which a reinforeiment wire is- 2 threaded. in And. out of openings:in a biodegradable body according to the present 3 invention, tinforcement wire 510 may be bent at a selected point located between its A ends, typically at about the.mid-point.of the wire, and a small loop 512 may be created (similar to the sinall closed loops described above); As shown in FIG. 32, small loop 512 s may be entwined around a filament or the intersection' of ohe or more filaments, and 7 reinforcement wire 510 may be threaded in and out of the openings in body S00 as 8 described above, and may be secured to body 500 with loops 550, or any other suitable 9 mean, as above described. Both portions 514 of reinforcement wire 510 may be to synimmetrically led along both sides of body 500 following the sinuous/helical course of 11 the biodegradable filaments. As described earlier, by activating the superelasticity or 12 thermnnal shape memory of reinforcement wire 510, ends 560 an4 570 of body 500 may be 13 pulled together, resulting in a tighter weave. As a result, the expansile force of the stent 14 and its resistance to outer compression may significantly.increase. In one embodiment, as loops 550 may also be used in securing body 500 to a delivery system.

1 6 In one embodiment, the size of reinforcement wire 510 may range from about 17 0.005 inches to about 0.012 inches.- It is to be understood that increasing the size of is reinforcement wire 510. may increase the force with which ends 560 and 570 are pulled 19 together when the shape memory of the wire Is activated."It is to be understood that using 2o more than one wire may have the same effect as increasing the size of the wie.

as In one embodiment, reinforcement wire(s) 510 may be formed around a template 22 as above described. The rcinforcement wire(s) may then be programmed with 23 superlasticity or shape memory as described herein.

24 Bench-work With regard to the biodegradable version of the stents according to the present 2 invention, the inventors have used an open-ended plain woven nylon body (that is, the 27 filament ends were not coupled together to fdrm closed strutues after weaving) for za initial bench work. The tubulat body was woven using 0.007 Inch nylon filamenits. The COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:50 FAX 61 2 9810 8200 F B RICE CO.

01082 I number of filaments used was 16, andiheubconstraineddiameter of the tbe was 11 mm.- 2 In an unconstrained state, the size bf the weave holes was- approximately 1 mm. The 3 expansile force of the.tube wasreladtively good, and after maximum elongationtthe tube 4 readily reverted to its unconstrained diameter; Compressing:the tube from its two ends s longitudinally, thp expansile force could be increased considerably.. At the maximal 6 longitudinal compression, the diameter of thetubular mesh was :13mm. Holding both 7 ends of the tube, the stept.became virtually incompressible.

a A 0.06" 'nitinol wire was threaded through the holes of the unconstrained mesh in 9 the manner described earlier. The wire was a straight nitinol wire and was not formed on to a template and programmed with either shape memory or superelasticity. The straight 11 wire caused the mesh to elongate and the unconstrained diameter of the tube decreased to 12 9.5 mm (13% lumen-loss) though the other charateristics of the mesh did not change.

13 The woven tubular structure could be elongated completely as well as compressed 14 naximally." is 1.5 Oeduders is With refence to the illustrative embodiments showh in FTGS. 33A-G, 34, and 17 35, there:are shown ocluders for insertion and delivery into an anatomical structure. An is occluder according to the present invention may be* used.to substantially or completely 1 prevent the flow of blood though a vessel. Body 00 of the oceluder may be formed 2o using plain weave by the methods above described. The types of stuctres into which an 21 ocluder according to the present in tion may be placed include arteries, veins, patent 2 ductus arteiosus and the ureter. a In one embodiment of the present invention, an occluder may be formed by 24 weaving a body for use as a stent as above descried. The body may then be heated and allowed to cool as above described. The body may then. be remodeled mounted on S another template in a manner similar to the manner in which the body was.couplcd to the; 27 first template (e.guusipg a copper suppo wire)), ad .reheaed and, cooled in a manner 2a similar tothe.19iginal heating and .cooling.. The template that may: be used in the COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:50 FAX 61 2 9810 8200 F B RICE CO. [083 1 wmodeling may have the.desired hrape, of the occluder in:one embodiment, In -another- 2 embodiient, a tubular template, preferably with a smaller caliber than that of the original 3 template, may be used:. In this embodiment, after securing one end of the body to the 4 template using support wire or any. other suitable means,; the distance between the two endp of the body may.be appropriately decreased. As a result, the mid-portion of the body 6 will balloon outward (FIG. 33B). Depending on the distance betweenthe two ends of the 7 body, a series of different shapes may be created. The shapes may include a round shape S (IG.33A), an elongated fusiform shape (FIG.33B), a compressed fusiform shape 9 (FIG, 33C), a compressed fusiform shape with an inverted distal end (FIG. 33D), a flat disc configuration (1FG.33E), a shape in which the proximal and of the occluder is 11 inverted into the body of the occluder (FIG, 33F), a torpedo shape (FIG. 33G), etc. After 12 achieving the desired shape of the body, the other end of the body may also be secured to 13 the template. The bodymplate unit may then be eated and cooled again. The heaing temperatis and times disclosed above may be utilized.

is To increase the thrombogenicity of the occluder, (Le, the ability of the occluder to 16 prevent the flow of fluid) thrombogenic materials in the form of an occluding agent may 17 be enclosed within the body. Any suitable material may be used for the occluding agent.

is The size and shape of the occluding agent may be varied according to need. In one s9 embodiment, one or more threads of polyester may by used as an occluding agent. The threads maybe coupled to the body atone or bth ofthe en of the body using any 21 suitable means suh as sutures The threads may also be placed loosely within the body.

22 In another embodiment, DACRON threads may be used as an occluding agent. The 23 DACRON may be.coupled to the body at one or bpth, cns of the body using any suitable a means such as ,ounofilament sutures,aglue, or, the lc. The DACRON .may, also be placed loosely within the body. 2 I one embodiment of the present invention, a stretchable jacket may be 27 confiured to cover at easta on of the body of an ocuder (FG, 34). Any suitable S material may be sed fo th'e jackt. "In one e imen a jacket may be made of 29 polyurethane, In another embodiment, the jacket' ma aeoflicone. e jacket -59- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:51 FAX 61 2 9810 8200 F B RICE CO. Z084 1 ,.lay have athicknes; of abowt.02 tnmm but it ill -b nat n7 id that thy suitable-- 2 thitess may be suisUttited theetfr. the jalat miy.be i6upled to eithe iner Or 3 oi~ter .surface: f the body using ghue. heat, t "any othet suitable means. i:b ne 4 embodiment, by coupling the jacket to the outtr surface of the bbdy, the body may be s easily manipulated. within a hollow covering such Sa a sheath during the insertion arid 6 delivery of the occluder.

7 The closed structures of the cans of the body used as the occluder may be held a together using any suitable means. In one embodiment, a monofilament suture 9 (polypropylene, Prolene 5-0, 6-0, 7-0, from Eihicon) may be.used tohold the closed structures of the body together by threading the suture through the closed structures or 11 other nearby openings. In another embodiment, metal clips 710 may be used to hold the 12 closed structurs of t he body together (FIG. 35). In holding the closed structures is together, in one embodiment, the closed structures may be held together such that the 14 tubes of the delivery system (described in detail below) may easily pass through the is lumen of the occluder. In another embodiment, the cloped structutes of the ends of the 16 body may not beheld together.

17 During deployment of such as occluder, the intervendonalist is always able to is correct any misplacement by simply restretching the Wire mesh and repositioning the 19 body using the delivery system. Even after the distal end of the occluder has been released, the proximal end still remains attached to the delivery system offe .g another 21 safety feature for removal of the occluder.

22 The single wire mbodiment imky also be utled as a structure o cauing vessel 23 occlusion:. Such an occluhder should have at least two loops. IGS. 57A- Ilustrate a various single wire embodiment occluders. FIG. 57A illustrat body 700c template 300 after having been formed thereon using, for example, either the hand weave or 24 machine weave method described above. As ihown, body 700 of the.aocclder has 3 27 loops. At this stage of the development of the occluder illustrated in FIG. 57A body 700 2 is simply a single wire embodiment stem.

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:51 FAX 61 2 9810 8200 F B RICE CO. 0085 1 After thebody/tenplate unit has been annealed using, for example, the annealing- 2 method described above for.impaiting body 710 with.superelastic properties, body 700 3 .may be-removed from template 300. Body 700 may then be stretched by pulling the two 4 ends thereof longitudinally apart, and collars .702 may .be. slipped over either end and placed at the locations where first segment 704 and second segment 706 cross each other.

6 Collars 702 may be small pieces of metal, such as small pieces of a nitinol tube 7 (commercially available from Shape Memory Applications, Santa Clara, CA). In doing 9 this, segments 704 and 706 extend between the lop-defining locations hidden by collars 9 702 so as to form loops 710, A collar702 may also be placed around the nds of the wire forming body 700. At the loop-defiOng -locations, which aie 'hidden by .ollars 702, n segments .704 and 706 may be positioned adjacent to each other. As used herein, 12 segments that are "adjacent" .to each other may or may.not touch each other, but such u sagments are positioned in close proximity to each other such that the distance separating 14 thorem is generally no more than about I mm- The length of the wire segments covered by Is collars 702 should. be sufficiently short so as not-to inmpede the flexibility of the single as wire embodiment occluder, n Although not shown, it wi be. undertood to those of skill in the art, with the as benefit of this disclosure, that any suitable means may be used to secure segments 704 19 and 706 adjacent to each other in the loop-defining locations. Such means include 2o wrapping the segments together with any suitable wire, crimping a piece of metal around 21 the segments, welding the segments together, and the like.

as With collars 702 in place, the shapes of loops 710 are altered such that loops 710 23 possess generally compressed shapes. As shown in FIG. 57B, the two largest of the three 24 loops 710 have faizly pronounced compressed shapes relative to the smallest loop 710.

S The compressed shape may exaggerated nmade more compressed) by decreasing the 26 distance between collars. Laterally pulling the portions of segments forming a given loop 27 apart may be done to alter the distance between collars. The collars should maintain the 2 shapes of the loops and thereby stabilize the occluder within the anatomical structure into 29 which it is delivered. However, the collars may be crimped to further improve their -61- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:52 FAX 61 2 9810 8200 F B RICE CO. Z086 1 aibility to maintain the shapes of the loops. In this same regard, body 700 may be secured-- 2 to a template having a suitable shape and re-annealed so that the compressed shapes of 3 loops 710 are maintained. Further, re-iamealing. body 700 may improve the expansile 4 force and resulting self-anchoring capability of the single wire. embodiment occluder.

s The number of loops utilized to form a single wire embodiment occluder may be 6 reasonably increased. For example, an ocluder formed using the single wire 7 embodiment may have 3,4,5,6 or more loops.

s .The shape of the loops of the single wire embodiment ccluders may be varied as S desired- to best cover the -cross-section of the anaobinical structuire to be occluded-in a so manner that will. likely cause occlusion n the most rapid manner plssible; Accordingly, a 1 ingle wire embodiment-occluder-may have loops that possess diffring sizes, such as an 12 occluder having one or more loops near one end that ar smaller than one or more loops 13 near the other end of the occluder. As used herein, the total length of'the segments that 14 define a loop that .is' "smaller" than another loop of a single wire embodiment is less than as the total length of the segments that define the larger loop. In another embodiment, the ni occluder may appear tapered, where the loops decrease in size from one end to the other.

IT In another alternative embodiment, one or two small loops may be arranged at or near the is mid-portion of a single wire embodiment occluder, while the loops at the proximal and 1, distal ends may be larger by comparison and possibly equal to each other in tenns of size.

21 In order to increase the thrombogenicity of the single .wire embodiment occluders, 21 various occluding agents may be attached to the ocluder. Any suitable material may be 22 used for the occluding agent. For example, pieces of a metal coil, such as one made from as stainless steel, may be pulled over the wire segments prior to slipping collars over them.

24 In this regard, the single wire embodiment occluder may be re-annealed as described above, the collars may be removed, the coil pieces may be placed over the segments, and a26 the collars may be replaced at the loop-defining locktions. As illustrated in FIG. 57C, 27 coil pieces 714 are placed over the segments between collars 702. The coil pieces may a also be wires, such as stainless steel or nitinol wires, that are manually wrapped around -62.

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:52 FAX 61 2 9810 8200 F B RICE CO. 1087 1 the segments and attached to the-segments in any suitable fashion. The coil pieces may- 2 be pre-formed hollow pieces of coil made from any suitable metal or alloy.

3 Thrombogenic filaments (such as polyester fibers) may also be attached to coil 4 pieces 714 .to further increase the thrombogenicity of the single wire embodiment S ocoluders, As illustrated in FIG. 57D, polyester fibers 716 are attached to coil pieces 714 6 at various locations along the coil pieces. The length of the thrombogenic filaments may 7 vary, as may the distance between the filaments, in order to ensure that the resulting a thrombogenidty of the single wire embodiment occluder is best-suited to the application.

9 The thrombogenic filaments may be individual fibers or bundles of fibers.

0o In another cmbodiment.,segments of the single wire embodiment occluder may be 11 covered by bundles of thrombogenic filaments, esuch as filaments made of polyester, such 12 that the bundles resemble the coil pieces, and additional thrombogenic filaments, such as 13 polyester fibers, may be attached to or braided with the bundles of filaments such that 14 they extend away from the covered segments in the same fashion as fibers 716 illstrated is in FIG. 57D, 1i Dli: very Systems for Steant, Stat Graft and Occuders 17 With reference to FIG. 3, the delivery system 20 for body 10, tapered body 100 Is and body 700 (including biodegradable versions thereof), may consist of two flexible 19 tubes arranged coially. These tubes may be formed of material such as TEFLON or NYLON, which are commecially .available from Cook. Inc. (Bloomington, IN), or other a similarly suitable materials. It is to be understood that material that is less flexible or 22 firmer than TEFLON may also be used. Further, it is to be understood that material with 23 a thinner wall thickness tanthat of TEFLON tubing, such as the material from which the u2 WAILSTENT delivery system is formed, may be utilized. In one embodiment, one or S both tubes may be made of metal, such as nitinol, which is commercially available from 26 Shape Memory Applications. Nitinol tubes may be particularly well-suited for use in ,27 delivery systems that are relatively large or rigid, such as for tracheal or bronchial as stenting. -63- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:52 FAX 61 2 9810 8200 F B RICE CO. 2I088 I The size of the outerdiamAter of the distal,'small caliber tube 22 may range from- 2 2.5 to 7.5 French ("F'):depending on the application :ofthe stenftthe'size of the stemn, and 3 the number of scouring wires (to be discussed below) that may be used to secure the stent 4 to tube 22 (to be discussed below). For coronary applications, for example, the size of tube 22 may be about 3-F. For delivery of a medium stent into the renal or carotid 6 arteries, for example, the size of tube 22 may be about 5-F. The length of tube 22 may 7 .range from SO cm to about 120 cm depending on the application of the stent and the size I of the stent. In an exemplary embodiment, for example, for delivery of an iliad artery 9 stent from a contralateral approach, the length of the tubing may be about 90 cm- In another exemplary embodiment, for carotid artery stenting, the length of the tobing may n be about 110 cm. The size of the stent may also have affect theJength of tube 22. Thus, 12 in an exemplary embodiment, the larger the stent diameter,: the longer the stent is in its 13 completely elongated state.

14 Tube 22 as well as tube 40 (discussed below) may be provided with a flange or is hub near its proximal end so as to allow for control of the position of tube 22 during 16 delivery of the stent. In an exemplary embodiment as shown in FIG. 25, a push button 17 lock/release mechanism 200 .(such as a FloSwitch®HP devico firomi Meditech/Boston is Scientific Corp., Watertown, MA or a CRICKETT device from Microvena in White Bear 9 Lake, MN) may be titlized for securing tube 40 to tube 2 when necessary. As further illustrated in FIG. 25, an end fitting 204 with a side anm lmay be utilized with aluer-lock 21 mechanism and/or tightening screws for further facilitating delivery of the stent.

22 Athough not shown, it willbe understood by those of skill in the art, with the benefit of 23 this disclosure, that the hub or flange that may be provided on the ond of tube 22 may be 24 used to facilitate the connection between end fitting 24 and tube 22. Sililarly, although 23 hot slown, it will lie understoid by those of sill n the art, with the benefit of this 2s disclosure, that the end of tube 40 may be provided with a hub or flange that may be used 27 to facilitate the connection between push button lock/release mechanism 200 and tube 28 End fitting 204 may be equipped with separated lumens in a double channel system. One 2 or more steerable guidewes 203 may be utilized in the lume of tube 22 and in the so lumen of end fitting 204 for facilitating delivery of the devices described herein.

-64- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:53 FAX 61 2 9810 8200 FBRC o 8 F B RICE CO. [a 089 Itis to' be widetsteod'that radiopaque markers may be placd on tube 228at- 2 ippropdate-locAtions in a mmnne k'lnowin the art'Ini bide&'r to bto nablo viewing, of 3 ub 22 using fluoroscopy durlbhg ddliery of, the stent.- 4 As shown in R.F1;3, th distal,.smalr caliber tube 22 is equipped with ]pmxhMWa 3 tole 24 and distal hole 26.. DIstal hole 26 Mzay, N ~typically located betw=e about 0.5. and 6 About 3.0,cm frmmistalend 28 of tqbW 2,most typicajy about .1 cm. The location of 7th@ radopaue marker on tube .22 may affect .thits distance. The distace between holes a 24 and 26 w=y *e V Icully about 3 to,8 mm but mnost typically'abquz 3 toS mm. This 9 distance ma#y Oe affected by th -size of the securng wire 30. For -examnple,. the dist#Ace 16betwecm the bol~a zpay-decreae as the disrupter of wire 30 decreases. it Securig wire 30 may be placed within the lumen of tube 22 (the dotted line 12 indicates that securing wire 30 is located. within tube 22), and -may pass through holes 24 13 and 26 so as to fom salprfle iht acring loo1p fl between the two holms Distal 14 end 34 of securing whro,30 terziinates ,at or neg 4iszaI end 28 of tube.22..* Proximal, end of 16 Securing loop 32holds he mliloops (6 and106) rbends (8anid 108) of distal Is -being described. in. mr o.detail, below.-) Mvzagouuly, securing loop 32.also, prpvnts 19 'prematpre delivery of the stout. Thus, prior, to 4eflvezy of Abe stout distal. end 34- of securing wire, 30 passes out trough proximal hole 24. passes throgh the siall loops or 21 bead of die -sternt, and passes bock into, the lumen of -tube 22 through distal hole 26, 22 tenuinating prior to-dista end 28, thus. securing the diqWa end of ft-esout to tube U: it is 23 tu.be understoodthat securi9ngire 00-inay pasthrough, one :of the openings In te plain 24 weave of. body-l Dr. tapered body. 100 other tha ffhc small loop ad:106) or- bend (8 26 i inogt applic ations, securing wire 30 ranges in size *from about 0.006 inches to 27 about 0.011 incheibs in daer.However, the. size of seuring wire 30 In -any given 28 applicadon deopendsl upon several factors. For example, a large (in term of diamete) COMSID No: SMBI-0056365 Received by IP Australia: Time (t-Lm) 15:21 Date 2004-01-09 09/01 '04 FRI 14:53 FAX 61 2 0810 8200 F B RICE CO. ao9o Seuring wire provid resispane to 'the propensity of a stretched. stent to contract.

S tban= doesA, smaller wnire Additionally, when more.thaie secing wire is utilized the 2 size of thewires can be less than if only one securing wiret wre use' The scuringwires 4 of the present invention may be made of any of the shape memory materials described s ibove. Itin one embodiment, the securi s th psent tvet io are made of 6 nitinol. In Mothr embodimet, the scu n W rsf the preaMt ivention may be 7 f6rmed of nitinol hiavig about '55 to 56 Nickel nd about 45 to 44 Titanium a :(commercially available frol i Shape NMiemory Applicaiions). In an embodiment in which 9 the securing wires of the: pre-ent invent6ion are nitinl) (imtluding wires 30 and 46, io discussed beloW), the nitiol sedhuring wires may be heat treated as described herein or I I purchased from a manufacturdrstichw that the supethlastic properties of the nitinol may be 12 utilized.

13 The, proximal; la ger. c Jbet 4tube 40 iT also e pd with proximnl amd distal 14 -holes 42 and 44 typically located in' approximately the same location froM distal end 41 is of tube 40 as are holes 24 ind 26 fromi distal end 28 of tube 22 Thedistanc between .1s holes 42 and 44 is also comparable to the distance between the.holes in tube 22.

n17 The size of the outer diameter of the ptoxhumal tube 40 may range fromn about Is F to about 10-P depending on the application of the stnt, the size of t stt nt, and Me it number of securing wires that may beo used to senure the proximal end af the sttit to tube as 40 (to be discussed below). For coronary applications, for example, the size of tube 21 may be about 5-F. .In ant exemplary embodimnent, fot carotid ary etting, th size of 22 tube 40 may be about 7 to about 8-F. The length of tube 40 may1r'nge from about 70 cm 23 to about 110 cm depnding on the ipplicationi of -the stet ad the .ize of the stnt. In an 24 exemplary embodiment, the length of tube 40 may typically be about 10 cin to about 2S cm Ahorter than the length of tube 22. It is to be understood-that tbe;proximal ead of 26 tube 22 may extend beyond the proximal end of tube 40, just as distal end 28 of tube22 S extenda beyd distal end 41 of tube 40 as shown in FIG. 3. In an txemplary S embodiment, the factor that may primarily influence the o ofth delivery syMm 29 tubes 22 and 40) is the distance of the stented region frotm the access site (ty y -66- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:54 FAX 61 2 9810 8200 F B RICE CO. 091 I the.femoral artery). As with-tube 22 ,tuba 40;;may be,provided with. a flange or hub near,.- 2 its proximal. end so as to allow for control.of the position of tbbe 40 during delivery of the SIt is to be utnderstood that radiopaque markers may be placed on tube 40 at s appropriate locations in a manner known in the art in order to better enable viewing of tube 40 ising fluor scopy during delivery of the stent. 7 Securing wire 46 is positioned with the lumen of tube 40, and forms smaU-profile, tight securing loop 48 in the manner above described. Securing loop 48 holds closed 9 structures (4 and 104) of proximal end (2 and 112) of body 10 and tapored body 100 .in to position during delivery, and advantageously prevents premature delivery of the stcnt. It 11 is to be understood that securing -wire 46 may pass through one of. the openings of the n plain weave of body 10 or.tapered body 100 other than the closed structures, The closed u structures are secured using the manner described above for theloops or bends.

14 Securing wire 46 and securing wire 30 may be formed from the same materials as s the wires maldking up the stent Additionally, securing wire 46 may be approximately the 6 same ize as securing wire 30, and the same types of factors discussed above should be 17 considered in pizing securing wire 46, s In FIG..3, although only one6 securing loop is shown on either tube, it is to be 19 understood that more than one securing loop may be utilized on each tube to secure the proximal and distal ends of the stent. MWr securing loops may be achieved with the 21 same securing wire, or by using more securing wis As discussed above, the number of 2 securing wires that may eti used may depend on several factors, such as the amount of 2 force needd to elongate or Constrain the stent prior to delivery. For example, the more 24 resistant the stent is to elongation, the more scuring wires may be used in older to facilitate the stretching or elongation of the stent on the delivery system. By this means, 26 the ends of the stent can be suspended evenly around the tubes and the friction between a tubes and the profile of the elongated' stent can be reasonably decreased. An additional 2s factor affecting the number of securing wires may be th use of a guidewire (described -67- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:54 FAX 61 2 9810 8200 F B RICE CO. Q092 1 :.below). In an exeniplay embodimnt.iof.,-thedelivery systeM according to the pdsent- 2 invention, a guidewiM mate utilited during delivery (dcbcibed beloW). Aas rult, the 3 use of a guidewire will affect the amount of space within tube 22 available for the use of 4 the securing wire or wires. It is also to be understood that securing wires having tapered distal ends may be used no matter how many securing wires are used.

6 Body 700 may be secured to the delivery systems of the present invention the 7 delivery system depicted in FIG. 3, in the same manner in which body 10 and tapered a body 100 may be secured to these delivery systems as above described. In one 9 embodiinent in which the ends of body 700 are seced to tubes 22and 40, one smallprofile, tight securing loop may be used to secure each end.

tn With reference to another illustrative embodiment of the delivery system 12 according to the present invention shown inW FIG. 4 delivery system. 50'has tube 22 13 equipped with proximal and distal holes 24 and 26 in the -manner above described. As 14 shown, delivery system 50 may consist of thin-walled sheath 52 arranged coaxially with is tube 2. Sheath 52 may be formed of materials comparable to those from-.which tubes 22 if and 40 are formed. Sheath 52 may be about 1 cm to about 2.5'cm in legth, but typically 17 about 1.5 The distal end 54 of sheath 52 is connected or attached to tube 22 by is gluing, melting, heating or any other suitable means at a location typically between about 19 8 cm to about 20 cmqfom distal end 28 of tube 22, but most typically about 15 cm.

0 As shown in FIG.4, div system 50 may c of inverse tabs 60 whlch are 11 connected to or engaged with the distal end of tube 40. Inverse tabs 60 are connec ted to 22 or engaged with tube 40 by any suitable means, including the use of a inetal ring friction 23 fitted around tube 40, to which tabs 66 may be soldered, welded, or integrally formed 24 Inverse tabs 60 are connected or engaged with tube. 40 at a location that may be determined based on the completely stretched length of the stemn, Inverse tabs 60 may be 26 made of any suitable material, including those from which the wires of the stent may be 27 made, and further including stainless steel and other similar matrials.

-8- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:55 FAX 61 2 9810 8200 F B RICE CO, Q 093 i The following description applies to both body 10 and tapered body 100.- 2 However, reference is made only to body 10 by way:of exa(mple: 'Averse tabs 60 secure 3 proximal end 2 of body 10 in the following general manner. Inverse'tabs 60 are placed 4 within th lumen of body 10. Proximal ends 42 of inverse tabs 60 are then "threaded" s through closed structures 4 or other holes located near the proximal end 2 of body 6 Tube 40 is then moved in a proximal direction until closed structures 4 (or other holes) 7 are secured by the inverse tabs. The space created between sheath 52 and tube 22 may be 8 used to house inverse tabs 60 as below described.

S.Delivery of the Sents, Sent Grafts and Occluders t0 Body 10 and tapered body 100 (including biodegradable versions threof), and I1 body 700 may be delivered in a similar manner. Thus, the following description of 12 methods of delivery for the sMts .and occluders references only body 10 by way of is example.

4 Prior to delivery, a stent in the form of body 10 may be manually secured to tubes Is 22 and 40. This may be accomplished by using either securing loops in the manr 1i described above with reference to FIG. 3 (hereinafter "version or by securing loop 32 17 and inverse tabs 60 in the manner described above with reference to FIG. 4 (hereinafter is "verion 1 9 In either version, a stent is first stretched so as to reduce its diameter by an amount w appropriate to allow delivery to occur. Thus, the stent may be stretched maximally or just 21 to an extent such that it may be inserted into a vessel or non-vascular structure, and may 22 pass though the lumen of the vessel or non-vascular structure as the stent is being 23 positioned prior to being delivered into the vessel or non-vascular tubular structure a When delivering the single wire embodiment discussed above, it should be noted that thq ratio of the constrained length of the body to the unconstrained length of the body may be significantly greater in this embodiment than in the embodiments that utilize multiple 27 wires. Therefore, the single wire .ebodiient may require a greater length within the COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:55 FAX 61 2 9810 8200 F B RICE CO. 094 I vessel or non-vascular structure in .which to be manipulated and prepared for delivery- 2 than may other embodiments that u e mtipiz m e wires; 3 The stent to bedelivered may be stretched by increasing the distance between the 4 distal ends of tubes 22 and 40. This may be accomplished by moving or sliding tube s in a proximal direction Over tube 22 while holding tube 22 stationary, or by moving or 6 sliding tube 22 in a distal direction while holding tube 40 stationary, or by moving or 7 sliding the tubes in the aforementioned directions simultaneously. Once the stent has 8 been appropriately stretched, tubes 22 and 40 may be locked together in a manner well 9 known in the art, such as-with the use of tightening screws dr push button mechanisms o Which are easily lockable and unlockabic. If version 2 is used, an outer sheath 70 as 11 shown in FIG. 5A may be used to cover inverse tabs 12 In an illustrative embodiment, it is preferable to Use h a gaidewire placed through 13 the lumen of tube 22 for use in guiding the stent to its proper location in a maer well 14 known in the art. The guidewire may be formed of any material from which the wires is forming the stent may be made. The guidowire may be between about 0.014 inches and 16 about 0.035 inches in diameter. In one embodiment, the guidewire may be made of 17 nitinol (commercially available fro Microvena). In another illustrative embodiment, a in hollow covering such as a sheath may be placed over a stent secured to tubes 22 and 40 so 19 as to prevent contact between the stent and the vessel or non-vascular structure during delivery of the stent.

21 'The first step of inserting either delivery system into the body is to establish an 22 access (arterial or venous). After puncturing the vessel using an adequate needle, a n3 guidewire is inserted into the body. The needle is removed, and over the guidewire an a2 introducer sheath with a check-flow adapter and preferably with a side-port is advanced.

2s The guidewire is then removed. This introducer sheath, the size of which is determined X by the size of the delivery system to be used, serves as an access for the intervention.

1- In version 1. when the stent, still stretched on delivery syste 20, is positioned in as the desired location of the vessel or non-vascular tubular structure to be stented, the COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:55 FAX 61 2 9810 8200 F B RICE CO. ll095 I .sheath covering, the stent may be withdrawn, and. the.tubes maybe -unlocked, The stent-- 2 may be, positioned and then, shortened so as to achieve its unconstrained diameter in a 3 variety of, manners. In an exemplary embodiment, the distal end of the stent may be 4 -positioned in its final location prior to shortening the stent. Then, while maintaining the s position of the distal end of the stent, tube 40, to which the proximal end of the stent is 6 secured, may be moved distally over tube 22.. As a result, the distance between the two 7 ends of the stent.will.be shortened and the diameter of the stent will approach, and may S reach, its unconstrained, prefonped diameter. In another -embodiment, the proximal end 9 of the stont.may be positioned in its final location.prior.to shortening thestemnt. As such, so tube 40 may be held steady and tube22 may :be moved proximally within tube 40 in order i1 to shorten the. stent, .In another embodiment, the middle. of the stent may be positioned in 12 its final location prior to shortening, and tubes 22 and 40 may be moved toward each 13 other by,equivalent distances. The many manners in which the stent may be'positioned 14 and subsequeitly shortnued during delivery thereof benefit the operator by providing him as or her with the yversatility .necessary to deliver stents :within a variety of anatomical 16 Structures, 17 The.ability to compress the woven devices disclosed herein with the. present 1s delivery systems prior to releasing them is advantageous for several reasons. Not .only 11 does it assist the operator in achieving adequate contact between the woven device and 2o the wall of the aatoinicalstructure such that the.woven device is anchored as securely as 21 possible, it .also allows .the compressed device to' occupy the least-amount of .space along 22 the length of the anatomical structure as possible. When using the present occluders, for 23 example, care should be taken to limit the space along the length of the. structure where 34 ocluision is taking place so as to avoid potential complications like the undesired occusion of side braniche, and the prevention of the formation of collateral vessels 26 supplying the structures not affected by the treated lesion. Further, when using the 27 present filters, for example, the space along the vessel available for filter placement may 2 be limited by the presence of the thrombotic disease and/or other anatomical s considerations, such as the proximity of renal veint in ithe VC, the short, free segment of theSVC -71- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:58 FAX 81 2 9810 8200 F B RICE CO. Q096 1 Aother dValitage afforded isthe practm delivoty 4stch laj tof the ability- 2 :of an operator-to manipulate either or.both end- of the woven body beiig dliveid prior S to releasing those ends is the ability afforded the oprator to position the present woven 4 devices accurately in irregulady diseas6d 'anatomick scts. Anatomici stwrutires s are frequently irregularly stenosed; the distensibility or enlargeability of the diseased S segment may .be- irregular due to the. presen ce of tough sca ,tissue or a tumrior, for 7 example; and lengthy vessels "are natrally tapei ed. Bbeauseboth eiids of one ofthe S preaent woven devices. maybe ainultaneoidly manipulated while using the middle of the 9 woven. device as a point of referencer:ior to feleisb, the oprid tormay be able t6 position to the mid-portion of the device (such as a stent) proxiate the mid-poitio o6f the diseased it segment of the vessel and maintait that relationshi, while simnultaneously withdrawing 12 tube 22 and advancing tube 40 so as to accurately position the sterit along the diseased t13 segmet. Further, by increasing the ability of bthe opbrator to accurately position the 14 woven- device and, correspondingly, reducing the possibility that the woven device will s needt to be resheathed and reinserted, the present delivery systems allow the operator's job 16 of delivery lkss potentially disruptive to the diseased segment of the patient 17 Additionally, another advantage flowing from the fact that the present delivery is systems allow for compression of woven devic&s -lies In the resulting ibility of the 19 operator delivering a stemnt graft having a .relatively non-tretchible graft aterial like PTFFE to achieve amesh tightness that; in turn, may serve to creat better contact between 21 both the. woven stent and the graft material as well-as between the-stent gr-aft and the wall 22 of the anatomical struc. 23 One of thebenefits of using the present stents ,with the present delivery systems is 24 that the anatomical structun being treated can always be overstntad. The diameter of an 2s anatomical structure that is "overstented" is slightly smaller than the unconstrained 26 diamneter of the stent delivered therein. In contrast,.overstenting is not necessarily 27 achievable using delivery system that do not possess the present delivery systems' 2s capability to manipulate the distance between the ends of the device being delivered prior 29 to stent release. Stents that are released using such delivery systems may remain -72- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:56 FAX 61 2 9810 8200 F B RICE CO.

Z097 elongated within the anatomical snuwture into which they are delivered and, as a result,-- 2 may not have .aradial .fo sufficient to resist outer cofipressina,: which in turn could a .compromise the patency of the strutum. Further, insufficient rtdial force could lead to 4 stent migration. With the present: delivery system,- however, the present stents, for s example, may be chosen such that their diameter is significantly greater than one hundred 6 and ten percent of the anatomical structure being stented (110% being the norm for 7 balloon-expandable stents, for example), such as one hundred and twenty percent, for s example. Consequently, the present stents may be delivered so as to be slightly elongated 9 within the anatomical structure in which they may be delivered the mesh tightness of to the stent may be less than the tightest achievable), yet may retain enough expansile force 11 tkee t the sructume patent, withstand outer compressive forces and be unlikely to 12 migrate.

13 The overdistention. or. overstenting of an anatomical structure using one of the w1 present stents that is substantially orcompletely compressed may be.beneficial for several reasons. For example, the overstenting helps ensure that the stnut will remain fixed in its 1t original location and will not likely migrate. The inventors have discovered that when the 17 present'woven bodies are compressed prior to being released, they contact the anatomical i structuri more securely than if they are released without first being compressod. Further, 19 as the overstenting may be achieved using a substantially or maximally compressed stent, the near-maxinum or maximum radial force of the stent may also increase the stent's 21 ability to withstand greater outer compressive forces without elongating and thereby 22 compromising he patency of. the structur being stented, .Although overstening is 3a described above, those of skill in the art will understand with the benefit of the present 24 disclosure that the same principle applies with. equal, force to the. woven. filters and as occluders disclosed herein, and the single wir embodim'r of each, rd may .be 26 achieved in the same manner.

27 The Wihisten patentdiscloses a delivery for the WAILSTENT that allows m the distance between the ends thereof to be manipulated prior to the release of the WALLSTENT. However, this delivery system (depicted in FIGS. 5 and 6 of the Wallsten -73- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:57 FAX 81 2 9810 8200 F B RICE CO. (098 parent) suffers from a .umber of shortcomiUgs that:are 6vetcome by the present delivery 2 systems. For example the Wallsten ;delivery system involves a number of intriate parts 3 (such as annular members, latches, rings, cables for displacing the rings, and a casing) 4 that.version.1 does. riot .utilize and that would likely be time-cofisuming end expensive to manufacture.and assemble. In contrast, the simpl6kiesign of version 1 two tubes 6 and.multiple securing wires has few parts, and those parts are easily obtainable.

7 Another advantage afforded by the present delivery systems is that the device s being delivered is clearly visible during delivery. No parts, once any delivery sheath bas 9 been removed from around the present delivery systems, obstruct the view of.the location so of the ends of the device being manipulated. Additionally, the profile of the present i delivery systems is no greater than that of the device being delivered over tube 40 (the 11 larger of the delivery tubes). This is advantageous because the smaller the profile of the a delivery system, the less likely the diseased segment of the structure will be unnecessarily 14 disrupted or traumatied during the positioning and delivety of the woven device.

is It is possible to overstent anatomical structures utilizing the present delivery 16 systems and present stents through the longitudinal movvment of tubes 40 and 22 in both at version 1 and version 2, the latter of which is described below. As described above, these Is tubes may be moved relative to each other such that the,..stent being delivered is ,o compressed maximally or nearly naximally prior to being eleased.

so If the stet is not in th desired-location after ireaching itsprformed diameter, It 21 can advantagnously be swetched and repositioned by moving tube 40, proximally and 22 locking tube 40 to tube 22 if so desired: After' loiki his occurred, the siteit may be 2s repositioned and the proiesi abovei escribed may be rpeated as needed This process.

24 nay be complete when the 'tent is positioned in the desid location, and the stnt fits in 2s the vessel or non-vascular tubular strucure in a way that the sitet is nearly maximally 26 expanded and/or the tissue of the vessel or non-vascular tubular stuctur is stretched 27 slightly.

-74- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:57 FAX 61 2 9810 8200 F B RICE CO. (099 I ."After perfonming this process;,-tA distal end of the sterit-may then be released- 2 fomn its secured position,. The -distal enM of the stnt may be so released by pulling 3 securing wire 30 (or wires) back into the lumen of tube 22, If the steout is still in the 4 proper position, the proximal end of the stent may be released iti the same manner so as to deliver the stent into the vessel or non-vascular structure, and the delivery system may be 6 withdrawn back into a sheath and Out of the body. If the stent is no longer positioned in S the esired location after relasing the distal end of the stent, the stent may be pulled 9 prximally back into a sheath by proximally moving tube 40 to which the proximal end of stent is still secured and/or distally movi ng the sheath. After doing so, the seut and delivery system may be removed from the body.

n It is to. be understood that the proximal end of the stent may be released from its 12 secured.position prior to releasing the distal end of the stent. Upon doing so, however, 13 the ability.to withdraw,the stent back into a sheath (if a sheath is-used) as described above 14 is no logger present,. Therefore, typically, the proximal end may be released ist when is the desired location of the stent will likely be maintained after such release.

In version 2, the stretched stent may be positioned in the desired location of the 17 vessel or non-vascular tubular structure to be stented. Then, prior to unlocking the tubes, t a sheath used to cover the stent, if used, may be proximally withdrawn so as to expose the 19 stretched stent. Also prior to unlocking the tubes, outer sheath 70 covering inverse tabs as 6 0 may be moved proximally so that inverse tabs 60 are exposed (see FIG. 5A). In an 21 exemplary embodiment, the outer sheath 70 may be withdrawn but not removed. The 22 tubes may then be unlqcked. It is to be understood that .the tubes may be unlocked prior 23 to withdrawing either.a.sheath usedto-cover thestretchedstent, or outer sheath 70. Once 24 this has occured, either the distal endor proximal end of the stent may be released ftm its secured position as follows.. In an exemplary embodiment, it may be preferable to 6s release.the distal end of the, stent first; because the secured proximal end may offer the 27 'Wpossibility of removing a misplaced stout as. above described. t t is to be. understood, 28 however, that because of the completely controlle4 nature of the delivery system of the COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:58 FAX 61 2 9810 8200 F B RICE CO. Z100 1 pmsent invention, the nee4 to remove ;-ami.placed stent may be very lowand, therefore;.

2 the proximal end of the stent may be rleased first.w out great risk; a When the distal end is to be released frst, tube 40 may be moved distally over 4 tubes 22 (see FIGS. SB and C) until the distal end of tube 40 reaches a pre-determined point located on tube 22, which in an exemplary embodiment, may be denoted through a the use of a radiopaque marker. The point is located along tube 22 such that the proximal 7 end of the stent will not be unhooked from inverse tabs 60 when the distal end of tube S reaches it When the point is reached by the distal end of tube 40, the tubes am locked 9 together. Additionally, another marker may also be used on the proximal shaft of tube 22 to denote the same point. If the stent is no longer in its ideal position at this point, outer 11 sheath 70 may be moved distally and/or tube 40 may be moved proximally to cover 12 inverse tabs 60, and the delivery system and the stent may be withdrawn into a sheath and 13 removed from the body. If the proper position has been achieved, the distal end of the 14 stent may then be released in the manner above described. Next, the proximal end of the is stent may be released by unlocking the tubes, and moving tube 40 distally over tube 22 16 until inverse tabs 60 release the openings or closed structures through which they were 17 threaded. tube 40 may then be further advanced distaUy until inverse tabs 60 are hidden is or houised within sheath 52 as shown n FIG. SD. At this point, the tube may be locked 19 together to maintain the position of the inverse tabs within sheath 52. After both ends of me stent have been released (see FIG. SE), delivery system SO may be withdrawn into a 21 sheath and removed from the body.

22 In version 2, if the proximal end of the stent is to be released firt, the sequence of 23 events just described may occar (including the ability of the. stent to be istretched and 24 repsitioned), except that the'distal end of tUbe 40 may extend distally beyond the predetermind point such that inverse tabs 60 unhook the proximal end of the stent and 2 .then go on to being hidden or housed within sheaith 52 atshown in d. of FIG; 5. After 27 the pmximal end has been released, the distal end of the stent may be released in the 22 manner above described. At this point; the tubes may be locked together to maintain the -76- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:58 FAX 61 2 9810 8200 F B RICE CO. [101 S position of the-inverse tabs within sheath 52. Delivery system 50-may-then be withdrawna from the body as above described.

3 The delivery of the present stent grafts that utilize graft material that is stretchable 4 as described above may be achieved with the same delivery systems and in the same s manner as the delivery of the present. "naked" stents. When a graft .material,.that is 6 formed from relatively non-stretchable material, such as, PTFE, is utilized,. howeyver, 7 although the same delivery systems may be utilized, the manner in which the stoet graft a may be delivered is slightly different from the manner in which the naked stents may be 9 delivered in terms of the manner in which the stept graft may be repositione4, if necessary. 11 :For example; if after reasing the distal end of the snt graft, whether the graft 12 material is attached to the stent at the proximal r distal end thereof, the stent may be 13 estretched over the delivery tubes and the stent's completely elongated position may be 14 secured using the proximal- lock mechanism. Then, th& introducer sheath may be is advanced over the proximal end of the stent graft, possibly as it is rotated in order to to recapture the graft material and the stent itself. Attaching the graft material to the stent at 17 -the proximal end thereof may make it easier to re-sheath the graft material using the In process just described, and thus may facilitate repositioning, if necessary, because the 19 graft material may take on a ftrnel shape prior to the rlOease of the proximal end of the stent graft.

21 Devery f Stens in Side-BySideh RflAiwnship 23 24 26 27 28 The delivery of these stents may be accomplished relatively simultaneously, such that neither steut occupics more space within the aorta than doeas the other., Initially, the stents may be secured toeither version of the delivery systems described above using the methods described above. As illustrated in FIG. 58A-D, in addition to securing the ends of the stent to tubes 22 and 40, the stent mtay also be scured to either tube (tbbe 22 as shown, for example) near the portibn of the stent that will be positioned near the bilateral aoto-rinal junction 830, which consists of aorta 832, left renal atey 834 and right renal -77- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:59 FAX 61 2 9810 8200 F B RICE CO. IM102 artery 836, FIGS.- 5.A-D. illustrate, only one .stent being delivered, but it will be, 2 understood to those of skill in the art,. with the benefit of this disclosure,.that, as stated i above, two stents may be released and delivered relatively simultaneously in the fashion a described below. As shown, guidwire 203 may be utilized to enhance the s m uanuverability of the delivery system. (The fittings that may be used to secure tubes 22 a and 40 to'eich, hich aim illustrated in FIGS. 25 and 26, aie not illustrated in FIGS.

7 SA-D for the sake of simplicity.) This third secured portion may be achieved using the a low-profile, tight securing loops described above. After stretching the stent on the S 'delivery system and positioning the distal end of the stent in right renal artery 836 in the manner described above (FIG. the rlease and delivery of the stent may take place 11 by first releasing the proximal end of the stent (FIG. 58B), then the distal end (FIG.

z2 S8C), and finally the portion of the stent near junction'830 (FIG. 58D). Tubes 22 and 13 and guidewire 203 may then be..withdrawn from the patienL .It will be -understood to 14 .those of skill in the art, with-the benefit .of this disclosure, that the release of the various is secured portions of the stents may take place.in any.order suited to the anatomical a structure in quetion, 17 Combined Tratment ofAnemysms Consisting ofStent Placement Is aid T nseaseter Emboltart on it In one embodiment of the present invention, the straight stent may be used for 2 aneurysm treatment without being equipped with a graft material. In this embodiment, 21 the "naked" stent may serve as a scaffold for developing an endothelial layer on the newly as formed vessel linen, while the ancurmymal sac may be excluded from circulation by 22 transcathter embolization.

2 Generally, the stent may be delivered into place, and an enbolic agent 96 may be 2S inserted into the surroundngi aniysmal site as shown in FIG. 36 26as As shown in FIG. 36 once the stent is in .the appropriate position, an 27 angiographic catheter 95 (5-French to 7-French) that is che.ically compatible with the n embolic agent (and not made from polyurethane when the embolic agent contains DMSO) -78- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:59 FAX 61 2 9810 8200 F B RICE CO. [a103 1 may be inserted and. advanced-intothe lumen of the stent. Lnadvancing the angiographic- 2 .catheter into the lumen of the stent, one may use the .same guidewire which may have a been used in delivering the steft However, one may advance the ahgiographic catheter 4 without the use of a guidewire. An adequately sized microcatheter 97 (2-French to 4s French) that is also chemically compatible with the embolic agent nmy then be advanced a through the angiographic catheter, on an appropriate size guidewire (0.014-inches to 7 0.025-inches). The tip of the microcatheter may then be led through the weave of the Sstent Into the aneuiysmal sac. If the openinigs in the weav'e of the stent are approximately 9 2.0 to 2.5 m, angiographic catheter 95 may also be advanced into the aneurysmanl sac.

t0 An embolic agent 96 inay then be inserted into the aneurysmal sac through the i microcathetet. Embolic agent 96 may be chosen. so as to be: non-toxic, non.

12 inrtantl/eactive to the tissuc; casily handled; suitable for continuous injection; 13 adequiately radiopaquei capable of filling the space contiguously without leaving 14 unoccupied spaces; and non-fragmented, thereby not getting back through the stent's as weave into the newly fboned lumen which could result in peripheral embolization.

t Although, several fluid emboliQ. materials (alcohol, .poly-vinyl alcohol, 27 cyanoacrylates 3thibloF etc.,) ae available for trnscatheter vessel occlusion, none of Is them is considered Ideal or even suitabl; for this .prpse. Recently, a noiadhesive, 19 liquid embolic agent, ethylene vinyl alcohol copolymer (EVAL), has been used clinically for treatment of cerebral AVMvs in Japan (Takld, AZNR 1990; Terada. J Neurosug 1991).

21 The co-polymer was used with metrizamide to make the mixture radiopaue and may 22 serve as the emboDlic agent fr the present invention.

Vcry icently, a new embolic agent (similar to EVAL), EMOLYX E (ethylene 24 vinyl alcohol copolmr) (MicroTherapeutics Inc., San Clemente, California) was as developed which waSdesigned for aneurysm treatment (Murayama, Neurosurgery 1998), 26 and may be utilized as n cinbolic agent in one embodiment of the present invention. The 7 omnbolic agent is 0composed of a random mixture of two subuits, ethylene (hydrophobic) S and ;vinyl acohol (hydrphilic). Mi"dronv ed tantawn powder is added to it to obtain an 29appropriate radiopacity, and DM S0 d-xhyl sulfoxide) is uied as an organic solvent.

-79.- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 14:59 FAX 61 2 9810 8200 F B RICE CO.

SWhen the polymercontacts aqueous .media, such as blood, he solvent should rapidly' 2 diffuse away from the mixture causing in situ precipitation knd solidification of the 3 polymer, with formation of a spongy embolus and'withtit adhesion to the vascular wall.

4 Any kind of material with characteristics similar to those of EMBOLYX E may be used as. pn embolic agent for the present invention.' 6 The method just described may be utilized when the stent is covered as well. in 7 such an embodiment, angiographic catheter 95, which may be 5-F. in size, and a microcatheter 97, which may be 3-F in size, may advanced into the lumen of the covered 9 stent as described above. A trocar, such as one having a 0.018-inch pencil-point or diamond-shaped tip and made of any suitable material such as stainless steel or nitinol, a may then be inserted into the lumen of microcathcter 97. The sharp tip of the trocar may 12 extend beyond the tip of microcatheter 97 by about 2 to 4 mm. The proximal ends of is microcatheter 97 and the trocar may be locked together using a Luer lock mechanism. By 14 doing so, a sheath-needle unit (well known in the art) may be.created, which may then be is used to puncture the graft material and the stent mesh. Thereafter, using fluoroscopy 16 and/or CT in guiding the sheath-needle unit, the sheath-needle unit may be safely 17 advanced into the anurysmal sac. The trocar may then be removed, and microcatheter to 97 may be used for injecting the embolic agent as described earlier.

19 Both abdominal and thoracic abdominal aneuryams may be .treated as above described. In some other locations external iliac artery), pesudoanewysm and/or 21 tumor-induced corrosive hemonhage may also be treated as above described.

22 The size of the delivery system that may be used to delivr a stent without a graft a cover may be sufficiently small, such that insertion.of the stet ito the vessel may take 24 place following a percutaneous insertion. The delivery system .would also be well-suited 2s to negotiating. through tortuous vascular anatomy. The treatment described above may be 26 performed using interventional radiology techniques, thereby eliminating the need for 27 surgery. The embolization may oclude the lumber arteries from which the excluded n anemurysmal sac is freoquently refilled. As a result of using the treatment described above, 2 the endoleak from the patent lumbar arteries may be eliminated.

01104 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:00 FAX 81 2 9810 8200 F B RICE CO. W105 Filters 2 Low-Proftle Woven Cava Filters 3 The wires of the cava filters of the present invention may be made of the same 4 materials. asthe wires:of the tents The same number of wires may be used in forming 3 the cava filters as are used to form the stents. However, in an exemplary embodiment, 6 less wires are preferablyiused for the cava filters than for the stents. As with the stents, in 7 .an exemplary embodiment, as few as 5 wires may be used to form the cava filters for any s given application except the.single wire embodiment, which utilizes only one wire.

9 The cava filters may be created with a relatively loose weave allowing the blood to flow freely. In an exemplary embodiment, it .is preferable that. the distal end of the 11 cava filters is not completely closed. See FIGS, 68. Instead, the bent ends of the wires 12 (FIG. 7 and FIG. 8 show small closed loops, but bends may also be used) or the coupled 13 ends of the wires (FIG.6) are arranged to form a relatively round opening with a u diameter of about 2 to 5 mm. The size of the wires that may be used for forming the cava is filters other than the barbless stent filter (discussed below) ranges from between about 16s .009 inches and. about 0.013 inches, but is most typically-about 0.011 inches. The size 17 of the wires that may be. used for -forming the barbless stent filter ranges from between is about 0.008 inches and about 0,015 inches, but is most typically about 0.011 inches.

19 As with the stents of the present invention, the angle between the crossing wires of the cava filters is preferably obtuse. Similarly, at the proximal end FlG. 6) of the .21 filter, cither a loop or bend may be formed by bending the wires as above described.

2 When such closed structures are made at the distal end of the filters, the angle formed 23 may be acute as shown in FIGS. 7,8 and 9A. At the distal FIG. 6) or proximal end 24 FIG7 and FIG.8) of the cava filters, the wire ends may be coupled together to 21 form closed structures as above described.

26 Advantageously, the portions of the wires forwing the closed structures may be 2 bent outwardly into multiple barbs to anchor the filter, when located at the proximal ends -81- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:00 FAX 61 2 9810 8200 F B RICE CO.

106 1 jof the cava filters FIG. 7 and FIG. As used herein, "barbs" are portions of the- 2 ends of the wires that may be used to form the cava filter. By carefully selecting the size, 3 orientation and shape of the barbs, they may penetrate the vessel wall in order to better 4 .anchor the filter during use, but they.may also be disengaged from the vessel Wall as the s filter is.being retrieved but prior .to the filter being withdrawn such that .the possibility of 6 causing any damage to the vessel wall is minimal. As illustrated in FIG. 59, barb 74 of 7 closed structure 4 is penetrating vessel wall 73 at an angle 75 that is acute.. Although s angle 73 may be obtuse, the .inventors have found that barb 74 generally anchors the 9 filters more securely when angle 75 is acute rather than when it is obtuse. Beginning at side 77 of vessel wall 73 and extending to the end of barb 74, barb 74 may be about 1 to 2 i mm long. As shown, wire end 7 may be oriented at an angle that is roughly perpendicular 12 to the angle of barb 74 such that barb 74 is prevented from more deeply penetrating vessel 13 wall 73. Another example of suitably shaped barbs may also be found on the 14 RECOVERY filter, which is commercially available from C.R. Bard, Inc.

Is (w.wf ardcoi Murray Hil, NJ. 800 367-2271).

s The cava filtets of the present invention may be formid by plain weave using the 17 methods described above -for forming the stents. Of course, an appropriately shaped is template may be chosen. Shapes for the cava filters include a cone (FIG. and FIG. 7), as a dome (FIG. an houtglas. shape (FIG. and 'the shape of the barbless stent filter (FIG. The cava filters may also be heated as the stents ar, and may be allowed to 21 cool as the stents are. Additionally, in an xemplay embodiment, as with the tapered 22 sten, the filters may be woven on a cylindrical template, heated and allowed to cool, then 23 the body fanrmed may be remodeled ad then reheated on another template. In an 4 exemplary embodiment of the hourglass filter, for example, the body formed by weaving 2a may be heated and cooled, and then maybe remodeled into the shape of an hourglass by 26 narrowing the central portion using a material suitable for reheating such as copper/brass 27 wire; then the hourglass shaped body may be reheated.

as In an exemplary embodiment of the cava filters of the present invention, it may be 29 preferable to flare and compress the woven structure near the proximal end of a conical or -82- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:01 FAX 61 2 9810 8200 F B RICE CO. [a107 1 dome shape filter or near both the proximal and distal ends of an hourglass filter, forming- 2 a cylindrical portion with a relatively tight weave (see portions 140 in FIG. 6, FIG. 7 and S IiG. 9) prior to heating. The diameter over this portion may be virtually constant. In an 4 exemplary embodiment, this portion may be fonnrmed using the above-described method of S heating and cooling a filter that may not possess the desired portion, reconstraining or remodeling the filter to achieve the desired shape of the portion, securing the given 7 portion of the filter in the desired shape and heating and cooling the constrained filter a again..

9 Inan axemplary embodiment, this constant-diameter portion and/or th tflared ends Pof t cay filters may be. advantageously used for anchoring. By achieving strong II contact, between .the filter-and the vessel wall, the filter's, intraluminal position can be 12 further secured. The expansile force of the cavafilter (which depends partly on the 13 number and size of the wires which are used for making the structure) may be chosen so 14 as to ensure such strong contact. The use of the flared portions as well as the suitable is barbs may virtually eliminate the.possibility of migration.

s16 The cava filters of the present invention will be further described in more detail 17 below by the way of specific examples.

s Conical Filter FIGS. 6 and 7 19 With reference to.the illustrative embodiments shown in FIGS. 6 and 7, there are shown conical filters for insertion and delivery into vascular anatomical structures. The 21 conical filters include a plurality of wires which may be arranged in a plain weave a 2 dAescribed above so as to define an elastically deformable body 150. As shown in FIGS. 6 23 and 7, body 150h a wide and/or flared proximal end 142 and a distal end 144. The diameter of body 150 is larger at proximal end 142 than at distal end 144. The diamete of body 150 decreams from proximal cnd 142 to distal end 144. Distal end 144 may be 26 formed in such a way that almost no opening is left through which fluid might flow. As 27 discussed above, how ver, in an exemplary embodiment, it is preferable to leave a 28 relatively round opening with a diameter of about 2 to 5 mm.

-83- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:01 FAX 61 2 9810 8200 F B RICE CO. Z108 Sb. .Dome Fter -IG. 8- 2 With reference to the illustrative embodiment shown in FIG. 8, there is shown a dome filter for insertion and delivery into avascular anatomical structure. The dome 4 filter includes a plurality of wires which may be arranged in a plain weave as described s above so as to define an elastically deformable body 152. As shown in FIG. 8, body 152 6 like body 150, may have a wide and/or flared proximal end 142 and a distal end 144. The 7 diameter of body 150 is larger at proximal end 142 than at distal end 144. The diameter a of body 150 decreases from proximal end 142 to distal end 144. The degree of the 9 decrease in the diameter from the proximal to the distal end is not as steep as in the conical: version, however. As a tesult, body 152 nmoxe resembles d hemisphere than a n cone, Because of its hemispherical shape, the dome filter may occupy less longitudinal 12 space within the cava than other filters.

13 Hourglass nilter -FIG 9 34 With reference to the illustrative embodinefit shownin FIG.9. there Is show an is hourglass filter for insertion and delivery into a vascular anatomical structure. The t hourglass filter includes a plurality of wires which may be arranged in a plain weave as 17 described above so as to define an elastically deformable body 154. As shown in FIG. 9, In body 184 has two conical or dome portions 146 brdged by a harrow poron 148. The 1t diameter of distal and proximal ends 144 and 142 is larger than the diameter pf portion so 148. In an exemplary embodiment, distal end 144 is preferably not equipped with barbs.

21 The closed structures of proximal end 142 may be bent outwardly to foun barbs. The 22 lumen size of nanow prtion 148 may be selected so as not to cloe the lumen of the filter 2n completely. The hourglass filter shown in FIG. 9 has multiple filtrating levels; in an 24 exemplary embodiment there may be almost no difference in the fil iating capacity between the filtrating capacity of the center of the filter and the filtrating capacity of the S periplery of the filter because the blood may be filtered by the peripheral weave of both 27 the proximal and distal portions 146. FIG. 10 shows an hourglas filter placed in the 22 IVC.

-84- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:01 FAX 61 2 9810 8200 F B RICE CO. M109 Sd. Barbless Staet Filter- FIG. 51 2 With reference to the illustrative embodiment shown in FIG. 51, there is shown a 3 barbless stent filter for insertion and delivery into a vascular anatomical structure. The 4 barbless stent filter includes a plurality of wires which may be arranged in a plain weave s as described above so as to define body 400, which, like, all the other bodies in this 6 disclosure, is suitable for implantation into an anatomical structure. A. shown in 7 .FIG 5.1, body 400 may consist of base 402, mid-portion 404, and dome 406, a Base 402 may be made as a straight stent (as described above) with a given 9 diameter. As a result, base 402 may serve to anchor the filter within a vessel and may not to participate in blood filtration. In another embodiment of this filter, bas, 402 may also be 11 made with a changing diameter. For example, its lumen may be slightly .tapered from 12 base 402 to mid-portion 404. The mesh tightness of base 402 may approach the 13 maximm-achievable tightness 180"). Accordingly, the radial force of the anchoring 14 portion (base 402) will increase as the mesh tightness increases.

Additionally, by carefully selecting the diameter of base 402, body 400 may be 1s configured to retain its position within a vessel without thq use of barbs. As a riult, the 1t task of carefully selecting the size, orientation, and shape of the barbs that could is otherwise be used such that those barbs may b elevated from the caval wall so as to 19 greatly reduce the-possibility of damaging the vessel wall duing resheathing (as a result of repositioning or removing the filter) may be liinated. In an exemplary embodiment a2 of the barbless stent filter, the diameter of base 402 may be 26-30 mm, which represents 32 operable diameters in ninety-five percent of the populaton, which has an inferior vena 23 cava of loss than 28 mm in diameter. In an exemplary embodiment of the barbless stent 2A filter, the length of base 402 may not exceed 10-15 mm.

a2 As hown in FIG. 51, mid-portion 404 of the barbless stent filter includes strts 26 408, which are formed of twisted wires 5. Struts 408 are arranged so as to be oriented in 27 substantially parallel relationship with the axis of the portion or segment of the vessel in n which they are delivered or released. Struts 408 may serve to further stabilize the COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:02 FAX 61 2 9810 8200 F B RICE CO.

1 barbless stent filter within the vessel or non-vascuar structure into which the filter is- 2 delivered. For example, in the embodiment of the barbless stet filter shown in FIG. 52, a struts 408 may be slightly bent or boWed outward so as to increase the frictional forces 4 between the delivered filter a the vessel wl. As a result the self-anchoring capability s of the filter may be increased. In an emplary embodiment of the barbless stent filter, 6 the length of mid-portion 404 inay be about 5-10 mm 7 Turning.to the third portion of the barbless steot filter, as shown in FIG 51, the a mesh tightness of dome 406 may be loose, In one embodiment of this filter, the top 9 portion of the dome may be equipped with hook 410 to faciltate the rmoval of the filter.

to In such an embodiment, hook 410 may be small and mjde of metal or any other suitable It material, and may be firmly and permanently attached to wires 5. Similarly, although not 12 illutrated, with te benefit of the prient disclosure one of ordinary skill in the art will 13 inderstand that hook 410 may alsobe provided on the proximal ends of the other cava 14 filters disclosed herein. Additionally, the hooks on these filters may be used during the as possible repositioning or retrieval of such filters in the same way as may be used on the i6 barbless stent filter, described below in greawt detail.

17 I another embodiment, the barbess filter may be provided with two filtration as levels. As shown in FIG. 53, such a filter is composed oftwo domes 406 (arranged 19 iiversely), a mid-portion 404 having a tight stent mesh similar to the mesh of base 402 in the embodiments in FIGS. $1 and 52, and two, ntermediate segments 412 having short, a struts 408 between domes 406 and mid-portion 404. In one version of this embodiment, 22 both the top and bottom portions of the domes may be equipped with hook 410 to 23 facilitate thed rmoval of the 'filtr. 'Atensatively, either the top or bottom may be 24 equipped with hook 410.

2s The end of the barbless stent filters located proximate hook 410 depicted in FIGS.

51 53 may be positioned so as to achieve a variety of configurations. For example, the 27 ed nd ay be tretched sch thait the shape of domes 406 is closer to a triangle than the S shape depicted in FGS. 513, or the end may be comprssed -86i 1110 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:02 FAX 61 2 9810 8200 F B RICE CO. Ql111 1 The shape of the barbless stent filters may be formed using the methods described- 2 above for forming the stmts and other cava filters. For example, the barbless stt filter 3 may be woven onan appropriately shiped template. Then the filter and template may be 4 heated and cooled as above described. Alternatively, the barbless stent filter may be s woven on a cylindrical template and heated and, allowed to cool. Alternatively, prior to 6 heating and cooling, certain portions such as the mid-portion and. dome may be 7 reconsuained or remodeled, and the remodeled portion of the filter may then be secured a and heated and cooled again.

9 Biodegradable filters.

As indicated abQve, all of the filters of the present .invention (including the BI 1 filter discussed below) may be formed with filaments made of biodegradable material so 12 as to form self-expanding, self-anchoring, bioabsorbable, biodegradable filters that may, 13 in addition to functioning as filters, function as drag or nutrient delivery systems as a 14 result of the material used. In one embodiment, the biodegradable filters of the present is inventiori may be provided with reinforcement wires as above described.

4 The factors that may be considered in choosing the materials from which to form 17 the biodegradable stents, the materials themselves, th methods of forming the is biodegradable stents and reinforcing the stents with wies, apply to the filters as well. Ih 19 addition, one may alio consider the following: the flow conditions of the vessel into the biodegradable filters are placed high flow conditions within the vena cava), to better 21 ensure that the material and weave of the filter are chosen such that the filter may anchor 2a properly within the vessel; the rate of- degrdation of the chosen material as well as the a time at which the degradation will begin so that if the filter is used as temporary filter 24 (a described below), the entrapped thrombi may be attended to before the filtei degrades as to an extent that the ontrapped thrombi could be aeleised backinto the bloodstream.

26 Any of the cava filter embodiments disclosed herein may. be made from both 27 wires 5, (wires 5 may be made from any of the materials described above, such as nitinol) n and appropriate biodegradable filaments 540. Although the barbless stent filter is -87- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:03 FAX 61 2 9810 8200 F B RICE CO.

1112 I described below in this regpad, it is by way of xample only, apd with the benefit of the.

2 present disclosure. one having skill in the a.:t will understand that wires and 3 biodegradable filaments 540 may be connected tg:ach other a hereinafter described.for 4 the other embodiments of the cavafilters disclosed heroin.,.

s Base 40 may i ed fro wires 5, while dome 406 may be formed from 6 filaments 504, Which may be formed from an appropriate biodegradable material, such as one deseribed above in greater detail. In this embodiment, the transition between the two a materials may be created in mid-portion 404. The connection between each nitinol wire 9 and the corresponding filament may be made by using any suitable means such as glue, to heat, by wrapping the filament around the wire, or any combination of thereof. After 11 biodegradation of dome 406 has takai place, base 402 may. like a self-expanding stent, 12 be left behind in the body.

S. f. Single-wire embodiment filter 14 As with the occlurs, the single wire embodiment may also be utilized as a is structure for filtering thrombi within a vessel. The single wire embodiment filters may be 6 fannmed in the same manner as the: single wire .embodiment occluders ar formed.

17 Moreover, the single wire embodiment filters ar .simply .the single wire embodiment is ocoluders without any .thrombogenic agents attached to the body of the single wire 19 embodiment, filters. In this regard, FIG. 60 illustrates body 700 of a single wire o0 embodiment filter. The body has first segment 704 and setond segment 706 separated by 21 a bend in the wire that is :n the fam of. closed loop 6. The tody is provided with 22 multiple collars 702, which hide multiple loop-defining locations where the segments are :0 positioned adjacent to each other. (Adjacent has the same meaning with respect to the 24 single wire embodiment :filte. as it has .with:respect to ithe single wire embodiment 2$ occluders.) The.segments 704 and;706 extend between the loop-defining locations so as 2 to form multiple loops 710, which are designated in FIG. 60 by the segments that outline 27 them. Another embodiment of the present single wire filters is illustrated in FIG. 15. As 2* illustrated in both FIGS. 60 and 15, loops 710 of bodies 700 possess compressed shapes.

COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:03 FAX 61 2 9810 8200 F B RICE CO.

SDelivery System of the Cava Ftern 2 Version 1 shown in FIG. 3 may be used as the delivery system for the cava filters 3 (including each of the vesions described above) according to he preseit invention.

4 eliv ofthe Cow Fters s Prior to insertion aid delivery, a cava filter in the fort of a body 150, 152, 154, 4 400 (or biodegradable versions thereof), or body 700 may be manually secureed to tubes 7 22 and.40 of verion I as Obove described. The cava filter may then be stretched as a described above so as to reduce the diameter of its largst portion- by an amount 9 appropriate such that the filter may be inserted into a vessel (preferably with the use of an access sheath), and may pass through the lumen of the vessel as the filter is being Il positioned prior to being delivered into the vessel. FIG. 28 shows a filter secured to a 1n delivery system in a ompletely sretched state.

i3 In one embodiment of the method for delivering the cava filters of the present 14 invention, a hollow coveing siuch as a guiding sheath may be placed over the filter 1s secured to the delivery system to prevent contact between the filter and the vessel wall as 16 the filter is inserted and positioned for delivery. In 'another embodiment, a short, 17 introducer: sheath with a check-flo adapter may be used at the access site to prevent Is contact between the filter and the vessel into which' the filter may be inserted during 19 insertion. of the filter in such embodiment the intrducer-sheath may of may not be so used to cover the filter beyond the access site of the vessel.

21 The cava filters of the present inventiorr may e stretched completely on the 22 delivery system, reducing their diameters as much as posiible, as shown in' FIG. 28, for 23 example. In one embodimeitbt after being secured to.the delivery system and stretched to 24 some extent, a filter may be delivered into the inferior vena cava In such an 2s embodient, the filter daybe inserted into either the right or the left femoral vein, 26 allowing for a femoral approach.- In such a enbodimeft, the filter may be inserted into 27 the internal jugular vein, allowing for a jugular approach. In such an embodiment, a filter -89- 1113 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:03 FAX 61 2 9810 8200 F B RICE CO. 114 and delivery systen with a lavey small profile, such as 7-F, -for example, may be" 2 inserted into a peripheral vein (pl.,antecubital vein), allowing, for a peripheral approach, if the system is sufficiently flexible, As discussed above with regard to.the delivery of the 4 stents, the construction of the delivery system enables one to use a guidewire in the lumen s of tube 22 for delivery of the filter, in an excmplary emrbodiment of the present invention.

6 It is to be understmood however, that a guidewite may not be utilized at times.

7 ach of the dava filters ma be delivered iito place iii dite manner described above a Vith regard to thde delivery of te stents using version.1 bulivery of the Sents). All S the :ad ntage describd :above "with r'prd to repositionability, etc., including the advantage of being able to bompress the filter bdng delivered and aciieve as tight a mesh u hi. the cylindrical; portions ithfief (such as base 402 of the barblWes stent filter) as 12 possible, apply equally to thie delivery6f th6 cava filte. Further, i instances' in which one of the present cava filters is delivered iri the TVC, for exanmple, the elasticity of the 14 PIC wall allows the operator to, achieve an ven tighter mesh than the mesh originally is created after th# annealing process.. That is. a filter pnfigure with an angle a of 1550 t may ,be. compressed during deliry.until, angle a is 1701. and, if the filter is propely 17 oversizd, the clasticityofthe IVC wall:may.mi*nt p angle a,at viy.close. or equal to is 170; Thep .ability of the pe#rnt deHvery system to achieve this scenario is especially 19 advantageous when jhe filter is createdwithout barbs so as to maintain: its position within 2o the vessel into which it may le delivered by virtue.of the radial force between the filter .21 andthe vessel wall. as .The weave of the presen:t filters,(including those discussed below) is. especially an suitable .to advantageously allow mechanical thrommbus-s ction to. remove the entrapped 24 clots without the risk of dislodg~g the .thrombi and allowing ,them to travel to the as systemic and pubnonary ciroulation.. In.so. doming,. an adequately sized catheter with a 26 large lumen may be inserted.into the filter's lumen and. used to sa k .the thrombi out This method may be.used in combination with thrombolysis.: COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:04 FAX 61 2 9810 8200 F B RICE CO. 115 a Non-perusamnt cvafilter applkatong a A f the wove cava filters, paticularly the conical, 4ome, and barbless stent 3 filters, may be used in temporary applications. ,A basic need exists to remove entrapped 4 thrombi saely and successfully befor removal of a temporary filtei. The emboli s entrapped by any kind of tempora filter can be dealt with in a variety of ways, such as 6 thrombolysis, placement of a permanent filter, or allowing small thrombi to embolize to 7 the. lings. The woven structure of the cava flters of the present invention seems a favoiible to preventeescape of the entiapped clots during thrombolysi. As a result, there is probably nojicd to place another filter above the woven tempttrary filter. This would to otherwise be impossible if the temporary filtr is delivered from a jugular approach. The It tempoary. applications of the cava filters include both tcmporary. and retrievable filter 1z designs, 13 Tempoary filters may be attached to a catheter or sheath, a tube or a guidewir 14 that may project froin the insertion site using a hub with a cap which is sutured to is 'the skixi for fixation), so as to allow for easy removal Of the filter. Retrievable filtersare t16 permanitfi flters that have a potential to be removed 17 Both the temporary and. the retrievable Alters may be delivered via. a jugular is approach. It.is to be pnderstood, however, that thasew.filters may also be delivered via a 1 fxmoral or anteubital approach., one embodiment, a temporary filter may be created by manually securing a cava i filter to two tubes in the Manner described above~ 'e outer t be to which the proximal 22 nd of the filter may be scured may comprise a catheter or sheath, or it may comprise a W tube such as tube 40 described above. Being a low profile design, the temporary filter 24 typ cally does not require an outer tu larger th 7 E a :After..properly positioning th temporat .ilter, the distal end of the tepormy 26 .filter may bel released using the -above dscrib d eth od. If the temporary filter is no 27 longer in the proper postipn. the filternay be withdrawn as shown.in FIGS. 274 and B.

-91- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:04 FAX 61 2 9810 8200 B RICE CO. 2I116 I 'FIGS. 27A and B illustrate tubl 71 -(which may, for exampleb be any suitably-sized-- 2 catheter or sheath) being advanced over a filter such that barbs 74 of the filter that 3 penetrate vessel wall 73 are disengaged from vessel wall 73 as tube 71 is advanced and 4 the filter is held stationary. A monofilament (not shown) may be threaded through one or s mot of the bends or closed loops defining the proximal end of the filter. Both ends of 6 the monofilament may be positioned in an easily accessible location (such as exterior of 7 the patient). The operator can then advance tube 71 over the ends of the monpofilament B (as described below with respect to monofilament loop 172 depicted in FIG. 12) while 9 holding the monofilament steady to disengage barbs 74 from vessel wall 73 prior to the to withdrawal of the filter.

11 After releasing the distal end of the filter, the holes in the supeilastie tubing 12 through which the securing wire or wires wens threaded may be used for injection of 13 some uroldnase or tissue plasminogen activator (TPA) to lyse entrapped tl.mbi within 14 the mesh. FIG. 26 depicts the situatioc In n which the distal end.pf the filter has been is released. As shown in FIG. 26, openings 27 may be provided in tube 22, in addition to 16 proximal and distal holes 24 and 26, through which urokinase or TPA may as.just 17 described. FIG. 26 also depicts introducer sheath or catheter 99, which may be utilized is in conjunction with the present delivery system to facilitate the insertion of the delivery 19 system, including tubes 22 and 40, inio the patient. (Note that push button lockirelase 0o mechanism 200 shown in FIG. 25 as connecting tube 40 and 22 is not depicted in FIG.

2 26.) noducer catheter 99 may be attached to end fitting 204, as shown in FIG. 26, with *22 a LUer connection. FIG. 26 also illustrates that multiple securing wires 46 may be 23 utilized for securing the proximal pand of the filter to tube 40. In this regard, although not 2a shown, it will be understood tothose of skill In the art, with the benefit of this diclosure, as that securing wires 46 may be controlled by creating openings in tube. 40 near the as proximal end of tube 40 and threading the proximal ends of securing wires 46 through 27 those holes. In this way, ihe proximal aidof the filter or other device may, be released by a pulling the proximal ends of securing wires 46. Tighlenng screw 205 may be provided 29 on the end of the side airm f end fitting 204: as shown in FIG. 26, for fixing the relative positions of securing wires 30 (not shown). Additionally, although not shown, it will be COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:05 FAX 61 2 9810 8200 F B RICE CO.

Sunderstood to those 9f skill in the, ar. with the benefit of this disclosure, that a tightening- 2 .sCqw maybe provided.onthe end of.cnd fitting 204 for fixing or securing the relative s position of any guidewires that are utilized as well..

4 In this embodiment of the invention, there may be no need to apply barbs/tabs at s the distal end of the temporary filter. For example, the barbless stent filter, by nature, will 6 not be equipped with barbs. However, such barbs or tabs may be supplied as shown in 7 FIG. 27A to the other filters. The proximal end of the outer tube may be secured to.the 8 skin using surgical sutures. When the filter is to be removed, the temporary filter may be 9 withdrawn into a catheter/sheath (such as tube 71) and the device may be withdrawn from o0 the body.

'a An additional manner in utilizing the barbless stent filter as a temporary filter 12 exists that does not involve leaving an outer tube in the body. In one embodiment, hook 13 410 may be used as a tool for removing a temporary filter. At the appropriate time, a 14 foreign body snare, such as the Amplatz Goose Neck snare (Microvena Corp., White Bear Is Lake, MN) may be used to grasp hook 410 and retract the filter into an appropriately S sized thin-walled sheath for removal from the body. The snared end of the filter may be 1v held stationary and an appropriately-sized sheath (approximately 2-French sizes larger is than the delivery system) may be advanced over the shaft of the foreign body snare to 19 capture the filter.

For the retrievable filter, the distal end may be equipped with barbs/tabs. At the 2 proximal end of the retievable filter, a mo.ofilameot loop is threaded through the small nt closed loops (or bends) created from the bent wires such that the small closed loops 23 become interconnected by the monofilament loop (see, e.g. FIG, 12); thus, pulling on the 2A monofilament loop will result in drawing the small closed loops together thus reducing 2s the diameter of the stet at the proximal end. The retrievable filter may be secured to the 2 same delivery system used for delivery of the temporary filter in the same way.

27 Delivery may also be carried outin the same way. In an exemplary embodiment, 2B the filter may be delivered from a right jugular approach. It is to be understood that if the -93- I 117 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:05 FAX 61 2 9810 8200 F B RICE CO.

1 d6dleriy system ia nal Menough, iasecubita, approah ma btac6 able, especially- 2 .fa shrt Ut6e filtratif- it is tt beunderatded that'delivery rm a filhor-al approach s may require the filter to be positioned inversely- After deliv6ry of the retrievable filter 4 from a jugular approach, for example, the delivery system may be removed and only the s monofilament loop Mtay be left within the vasculature. The very proximal end of the loop 6 may be attached to the skin as above described. In this form, the retrievable filter may be 7 used as a temporary filter. Both the flared base with the tighter mesh and the barbs/tabs a may serve to anchor the etrievable filter within the cava. In the case of the barbless stent 9 filter, base 402 may serve the function of the flared base of the other filters, which may or in may not be provided with barbs or tabs. If it is necessary to convert the temporary filter I1 into a permanent one, the monofilament loop may be severed and removed from the small 12 closed loops. of the filter as well as from the body..

13 If a decision is made to remove a retrievable filter, a short metal straightener may 14 be advanced over the proximal end of the monofilament loop. A short introducer sheath 1a may then be inserted in the access vein over the straightenei. Through the introducer, an 16 adequate size sheath may be advanced to the distal end of the filter. Stretching the 17 monofilament loop, the sheath may be advanced over the filter. As a result, the is barbs/tabs, if utilized, will be retracted from the caval wall, and the filter's removal can 19 be achieved without causing injury to the vessel wall.

The time period for leaving a temporary filter in a patient will vary from case to 21 case, but, generally, temporary filters may be left in place for no more than about two to 22 three weeks. Leaving them in place for a longer period of time may result in the 23 formation of a neointimal layer on the temporary filter, which would impede its removal.

24 To increase the period of time during which these filters may be left in the body without being embedded into the neointimal layer, the filters may be coated with some 26 biologically active materials cytostatics, fibroblast growth factor [FWP-1] with 27 heparin, Taxol, etc.) or the metal of the filter may be rendered -particle -mittimg 2 producing a low-rate radiation at the site of the filter placement (Fischell, 1996)., -94- [a118 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:06 FAX 81 2 9810 8200 F B RICE CO. 119 .The main advantage of the retrievable filter is that if the conversion from- 2 temporary to pennan nt filtration is necessary, there is no need to remove the tempbrary Sfilter and deploy a permanent one. Both versions are suitable for intraluminal 4 thromb6lysis both from a jugular or a femoral approach or possibly an anteoubital approach.

6 The retrievable filter provides additional advantages in that they are easily 7 retrievable, they possess equal filtering capacity in the center and at the periphery of the 9 cava, they provide safe thrombolysis, they .are self-centering and self.anchoring, and 9 ,unless hook 410 is utilized in conjunction with the barbless stent filter, it is unnecessary to use a foreign-body retrieval device which. might involve lengthy manipulations.

I1 However,, it is to be understood that, in some embodiments, small tabs may be coupled to 12 the ends of the filters of the present invention for facilitating the removal of the filter with n1 a foreign bodyietrieval device.

14 The cava filters of the present invention provide the advantage of .improved is filtration. The extended coverage of the filtering level comes with an improved thrombus 16 capturing capacity of the cava filters. The presence of a thrombus in a traditional conical 7 .filter decreapes the capture rate for a second embolus (Jaeger, 1998). The succeeding is thrombus will not .be able to-get into the apex of the cone and has a higher chance of 19 passing through. the filter (Kraimps, 1992).. The flow velocity, and theefore, the 2o hydrodynamic forae.arincreased at the stenotic site of the filter. Because conical filters 21 predominantly capturt thrombi in the apex of the cone, the site of increased velocity is 2 located at the periphery of the fier. As long as the diameter of the thrombi is smaller as than or equal to that of the stenotic opening, the locally increased velocity and 24 hydrodynanilc force will push the thrombi through the filter periphery.

2s .:Ing the cava filters of the. present invention, the. thrombi will be primarily 26 captured by the distal end of the conical and dome filters and.by the dome of the barbless 27 stent filter; ii the case of the hourglass filter, the first filtration level is the narrow portion a of the praoxmal end of the filter. Any subsequent emboli will be divefted to the periphry COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:06 FAX 61 2 9810 8200 F B RICE CO.

of the cava where the filter has approkinfately the same filtratio;capacity as ini the center,- 2 -of the filter.

3 The filtion capacity of a filter can be estimated by looking at It from the top or S below. The wires/mesh arangement in the projected cross-section of the filtered segment 3 of the IVC gives a good estimate about the "coverage of the IVC by the filter. For example, FIG. 29 depicts a.projected cross section of one of the present hourglass filters 7. taken across the middleportion of the.filter. In the case of the hourglass filter, the.blood I is primarily filtered by the proximal half of the filter, similar to the case using the dome 9 or conical filter. The blood which is .going proximally alongside the caval wall will be o filtered the peripheral mesh of both the proximal and the distal "dome". As a result, as in n the case.of the barbless stent filter, there.is virtually no difference in filtation capacity:of 12 the filter in th center and at the periphery. of the vessel. -Additionally, with respect to is each of the filters, the immediate opening and symmetric arrangement of the bases of the 14 filters serves to self-center them and prevent them from being tilted. Some filter designs is (especially the Greenfield- ilter) are sensitive to intraluminal tilting, which negatively 1s affects their filiration capability.

17 The flexibility of the. mesh of .the cava.filters, as is the case with all the -Woven is, intravascular devices of the present invention, makes it possibleto advance the delivery 19 system through tortuous vessels.. This feature together with the small size of the delivery system enables ,9e to deliver these filters via every possible access site of the body.

21 Further, as with all the intravascular devices of the present invention; the, plain weave of 22 the cava filters allows for the production of one coherent element, which does not po4sess any kind ofjoints.: s2 The cava filters according to the present invention may possess (depending on the 2s material used to form the wires thereof) a non-ferromagnetic character making them, as 26 well as stents formed therefnim MRI:eompatible.' 27 The cavp filters of the present invention are also suitable for intravascular 28 thrombolysis. After placement of any kind of filtering device, the development of caval -96- I1120 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:06 FAX 61 2 9810 8200 F B RICE CO.

0. n S thrombosis/occlusion. frequently .occus (Crochet, 1993), In acute cases, a possible- 2 therapeutic option is to recanalize the IVC by pharnnaco-mechanical thrombolysis. Doing 3 so in the presence of the currently available filters poses a high risk of developing 4 pulmonary emboli, because large fragments of the IVC thrombus can break off and be S carried away In ap uncontrolled w after urokinaseTPA treatment, One of the 6 acceptable options in that situation is to place another filter above the thrombosed filter to I avoid pulmonary embolism due to thrombolysis. Unlike other designs, the cava filters a according to the present invention may offer the possibility of a safe and successful 9 thrombolysis without the need for the placement of two filters.

to .i-a Tube Filt n The wires of the BI filter according to the present invention may be made of the 12 same materials as the wires of the stents. The same number of wires may be used in 13 forming -the BI filter as are used to form the stents. However, in an exemplary 14 embodiment,.less wire, ae preferably used for the BI filter than for the stents. It is to be undestood that .although only 4 wires appear in FIGS. 11-13, 2 more wires ame not 16 shown. The BI filter may be created with a relatively loose mesh allowing the blood to i flow freely. The size of the wires that may be used for forming ltE BI filter ranges from is between about 0.008 inches. and about 0.011 inches, but is most typically about 0.009 19 inches.

The BI filter according to the present invention may be formed using the above 21 described methods for forming the stents. Of course, an appropriately shaped template 22 may be chosen. In weaving body 160 of the BI filter, as shown.in FIGS. 11-13, the angle 23 a between the crossing wires.is preferably obtuse. It is.o be understood that angle a may 4 also. be less. than or equal to 90 End 164 may have a plurality.of closed structures which 2S may.be small closed loops 166 (FIGS. 1U and 13) or bends .168 (FIG. 11), like theabove 26 stents andfilters. The angles of thoseclosed structures may be similar, to the angles for 27 the closed structures of the stens as above described., The wire ends at 162 of body 160 way be coupled together in the mannme above described.

-97- 1h 121 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:07 FAX 61 2 9810 8200 F B RICE CO.

S .Body1 60 of the BI filter may also be heated as thestents are, and may be allowed- 2 to:cool as the stents are.

3 In one embodiment, the mid-portion of the BI filter may be constructed with a 4 larger diameter than that of the ends which are used for fixation. This may be achieved in s a variety of Ways using the remodeling methods above described. For example, one may 6 weave a straight stent with a caliber useful for filtration (larger lumen). Then, smaller 7 caliber ends may be formed by remodeling the filter on a smaller caliber template. In a such a case, the weave of the filtering level will be looser than those of the legs. In 9 another embodiment, the weave of the filtering level may be tighter than those of the legs by weaving the BI filter is on a template sized for the legs, and then remodeling the filter i1 by ballooning the mid-portion of the filter outward. Many variations in shape are thus 12 possible.

is The BI filterof the present invention may be stretched completely on the delivery 14 system, reducing its diameter as much as possible:, It may be delivered in that stretched is :state into the inferior vena iava It is tobe understood that it may also be t1 delivered into the IVC in a state.that is not completely stretched. The filter may be 17 inserted from either femoral. vein -and placed into both. ili veins forming an inverse Is U-shape bridging over the confluence of these veins. Unlike traditional IVC filters, the 1t filtration according to the present invention will substantially take place through the cephalad surface 163 of the weave at about the mid-portion of body 160 located at the at junction of the iliac veins, as shown in FIG. 11.

22 The BI filter is suitable for temporary filtration. In this embodiment of the present 23 invention sabown in FIG. 12. the coupled wire ends form the distal end of the filter, While 24 the multiple small closed loops 166 located proximally are connected by a monofilament 2s loop 172 as.described above and shown in FIGS. 12 and 13: FIGS. 12 and 13 illustrate 26 Bi-filter 160 delivered within .left Iliac vein 157 and tight iliac. vein 158, beneath the n inferior vena cAva 159. Using a contralateral approach, the filter may be inserted famn S either femoral vein and its front end may 'be positioned int6 the contralateral iliac vein.

29 After delivery of the filter, the monofilament loop may be led outside the body and -98- 1122 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:07 FAX 61 2 9810 8200 F B RICE CO.

secured to the skin. When there is no further need for the filter, itmiay be withdrawn by, 2 pulling it back by the monofilament loop through an advanced sheath.

3 In another possible embodiment of this invention shown in FIG. 13, a flexible, S4 superelastic wire or microtubing 174 made from nitinol (or similar superelastic/shape .memory material described above) is led through the lumen of the BI filter. The distal 6 end of the nitinol wire/icrotubing is attached or coupled to one twisted wire-end 170 of 7 the filter by any suitable means, including soldering, point welding, wrapping of fibers, a and the like. The proximal end of the wire/microtubing may be attached to the skin 9 (along with the monofilament loop). When the BI filter is being withdrawn, the wire/microtubing may be held steadily, while the monofilament loop is pulled. As a it result, the .I filter will be paially tretched facilitatingSthe filter's removal. The BI filter 12 may also be removed in the fashion described above for removing the temporary filter.

Is As discussed above, given the design of the BI-filter, one may catheterize the 14 lumen of the filter and, using an adequate size catheter, thrombus-suction may be easily performed before filter removal.

16 Deliery System ofthe BD Fiter; 17 Version 1 shown in FIG. 3 may be used as the.delivery system for the BI filter is (including a biodegradable version) according to the present invention.

SDelivery of the BI Fier A preferably preformed guiding catheter or a guiding sheath (Balkin sheath-type) z (FIG. 3) may be used for insertion of the delivery system for the embodiments discussed as above. The BI filter may be secured to and stretched out on the surface of the delivery 23 system in a manner described above, and may be delivered from the ipsilateral 24 femoral/iliac vein through the caval junction into the contralateral iliac vein. As s discussed above with regard to the delivery of the stents, the construction of the delivery 26 system enables one to use a guidewire in the lumen of tube 22 for delivery of the filter, 27 which is preferable in an exemplary embodiment of the present invention. It is to be -99, Q 123 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:07 FAX 61 2 9810 8200 F B RICE CO.

1 understood however, that a gaidewirT may. not be utilized .if: a'prefomned sheith is iwpla e. 2 place.

3 The.,B) filter may be .dliverd into place in-the manner described above with 4 egard t tthe delivery of the stents. uing version 1. All the advantages des cribed above s with regard tp repositionability, Wi.. apply equally to the delivery of the BI. filter. In an 6 exemplary embodiment of the dcjivery method for the. BI filter, the distal end of the BI 7 filter may be released.first.

a Advantageously, the BY filter according to the present invention may offer the 9 possibility of a safe and successful thrombolysis, like the cava filters above discussed.

;All of the methods and-apparatus disclosed and claimed herein can be made arid i) executed without undue experimentation in light of the present disclosure. While the 12 methods and apparatus of the present invention have been described in terms of 13 illustrative embodiments, it will be apparent to those of skill in the art that variations may 14 be applied to apparatus and in the steps or in the sequence of steps of the methods Is described hereit without departing from the concept, spirit and scope of the invention, it More specifically, it will be. apparentthat certain agents which are both chemically and 17 physiologically related may be substituted for the agents described herein while the same is or similar results would be achieved. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

-100- [21124 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:08 FAX 151 2 9810 8200 F B RICE CO.

1WKEW.E 2 The following references, to the extent that they prov~ide eztpmplaiy.-prcFedural or 3 other details supplementary to those set forth herein, are specificaily 4nq9uratcd herein 4 by referen ce.

s Een-Menachen2, Coidwell, :Y oung, -Burgess. "Hemnoirhage, associated with' pelvic 6 fractures: causes, diagnosis, and emetgtnt mnanagonrfit" AiR, 157:.1005-1014, 7 -199.1.

fling, Hicks, FI~enahau, Wick M, Picus, D, Darcy MD, Clayman RV., "Percutaneous zureteiU occl1usion with use of Glanturco coils and gelatine sponge, PartLI Swine to model" JVIR; 3:313-317; 199Z (a) 11 Bin;, WMoks, Pious, Darcy. "'Percutaneous, urezeral occlusion with use of Gianturo coils 12 and gelatine sponge, -Part II. Clinical Experience," IVIR'; 3:319-2i, 1992 (b) 13 Cambier, Kirby, Wortham, Moore, "Percutaneous closure of the small mm) patent 14ductus arteriosudusing-toil ezhbolzation," Am. J. Cb~diotv 69M815-816. 1992.

Crochet, Stora, Perry aL 1 f'Vcna Tech-LOM tlltw. long-term results of 4 *spective 16i study," Radiology, -188:9574860, 1993.

17 Dorfman, "Pcurceousiinfedor Vena cava filters," Radooy, -174:987-92, 1990.

1s Dutton, Jackson, Hughes, et at, 'Pulinouay rterio'venous inafminatios re-1sults Of 19 tatmeut with. coil emtbolizatlon in 53 patins, AR, 165:1119-1125, 1995.

Misoholl, Carter, Laird,' "Thej)-jarticlc-crmuing radiosotope sitent (hostnt): -animal 21* studies-and planned clinical ti As'r Am J. CardfioL' 78(Supl 3A):45-50, 1996.

22 Puruse, .Iwamaki, .Yoehinio. Xonish. arno, l14riahita, Ry% Stake,- 'Morlyamak 23 llspatocellula crctinotma with portal vein tumor thronibus; emblztion of 24 arterioportal $hunts," Radioloay, 2)4:787-790, 1997.

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n Grssiw ."Jnfeulor vena caa!ltersM Analysis of five currently a"'iable devices," A.12, 29 156:813-8217 1991.

[aj 125 COMS IDNo: SMBI-00564365 Received by IP Australia: Time (I-tm) 15:21 Date 2004-01-09 09/01 '04 FRI 15:08 FAX 61 2 9810 8200 FBRC o 2 F B RICE CO. IM 126 I Gnifka, Vmncsnt, Nihill, Ing, MUflS/17thtOT patent ductus utcziosus-closure In an- 2 infant using the Gianturco GtflA vascular occlusion, device,' Am Cardol., 3 718:72i123, 1996.

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is Hokin&, Benson, Musowe, Dyck, Freedom, Trnateroluiif o the peaitenty 16 patentductus artediosus," Crlatiion,84:2313-2317, 1991.

17Jaeger, Kolb, Mair, Cellar, Chriatmain, Kinnej Matas; "in vitro, nmodel for enaluat on of is inferior vona caya filtegs: .effect. of exporimental :parameters on thrombus- 19 capturing efficacy of the Yen Tech-LOGM Siter," MVR, 9,295-304, 1998.

Semnba. Dakei t"Use of a. self-expagdlng vascular.. occiwier for embolizatlon during 21 endovosclar mactic anezyam repair," .WR. 0:27-33. 1997-.

n2 Katsamouuis, Waltman, Delichatajos, Athanasouls, "Inor vents ca flter In vitro 22 -comparison of clot trappng an4 flow #rd cRdogy.6±3-6,198 24 K6nys, Wright, W4Ulspe,,!tAnchodnS coil embolization:,in a high-flow aztia) model:' J WR, 9:249-254, 1998.

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28 Koran Reed, Taylor, Pantecost, Teitelbaum, "Copmparison of filters. in an oversized. vanli 2, caval phantomr intracaval Placement of a Bird's Nest, filter vertus blillac -102.

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1placement' of (3renfield, W-nat-Tech-LOM and .Simonm htinol flltexV' I/JF' 2 3;559-564, 199.

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io Upton stat, 'Tercutanepus Rtetrieval -of two Wallstont'endoprostheses from the heart 11 through-a single Jugular sheath," JVLR 6:469'472Z 1995.

12 Lloyd,. Feddedy. Mcndelsoha, Sandhu, Beckman, transcatheter occlusion of patent 13 ducts arterlosus with Gianturco coils." Circulation; 88: 1412-1420, 1993.

14 Maal. Wrlgjn, Duprat. Wallace. Giwnturco, "A new devic for'transcathete closure -of is patet ductus arterlosas: a feasibility study in dogs;' Invest. Radiol. 24.6272-276, 16 1989.

17 Marks, Chgs, Lidldel. Steinbcrg& Panshian, Lane, "A mchanically detachable coil for the is treatment of anowryams and occlusion of blood 4essels," AJtIR, 15:821-827, 1994.

Walsh. Thanopoulous, Chan, Basn, Gonsous, GavOra, Hijazi, "Catheter closure of modeat. to large sized. patent 'ductu Arteriosus. using .the new Amplatz duct 21 occluclen immediat and short. tprm remlults," 3. Am.- Coll. Cardiol., 31-878-882, 23 Milward, "Temporary and. Retrievable Inferior veas cava filtew- Current- status," JWm, Murayamna, Vinuela, Ulboa, Aidha, Duckwfler, Ciobin, Vinters, Goe, "Nonadheulve' 26 4quid enibollo agot. for ceebral.-AIIeriGvCnOUs zuafoatlWm Pftliminary 27 histopathological istudies, in swine rete nrlrabile," Neurosurgwrj, 43:1164.1175, 28 19,98.

M9Nii~O elw 1 Lok S~lty of coil eofli: anin viro stUdy," ,Cardiovasc.

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O~b~in~Leggy ,MacFrlean, .Thernpeutic- ateial enxbolizatlonrm-repott -of five yeers'r* 2 experience," Clin. Radfiot., 354:85-93,1984.

3 Pouza, C0omet, Qimi, Anibroz~ltl& LiflMAjiplhtt, 'lntekthtt&i Oc lon-of patent ductus. artcziosus: using .a newly -developed. self-expanding- device: evaluation in a s canine model," hInvest. Radial., 30:104,109, 1995: Prahiow et al., 'Cardiac perforation due to Walistent embolization:. a fatal complication 7 ,of the transjugular intrahepatic pottosystemic shunt pirocedure," Ro4Iloy, a 205:170-1,72, 1997.

9Prjince, Salzman, -Schoen., Palestrant,. Simon, 'toAmW; inttavascular effflas of the nidinol blood clot fiter," Invest Radir4423:294-300, 1988.: 11 Punekar, Prem, Ridhorkar. Deshmukh, IKt1kar,, "Post-surgical, recurrent varicocele: 12 efficapy of intenal sperinatic, venography 'and steel-coil cmbolfitdcn," Br.'J.

13 Url., 77:12428,1996.

14 Rashkind, Mullins,.Helleubrand, Tait, "Nonsurgical, closure of patent ductus urlteriosus: is clinical application of the Rushkind PDA occiuder system, -cukuon, 75-.583- 16 52 97 17 Reidy arnd Qurashi, "Interlocking detachable -plaltinumi coils, "a'conhuollod emrbolfizati on is device: early 'clinical experience,-" Cardiovas. lnten'em. Radiot,. 19:95-90, 1996, it Sagara, MlAfyazono, -:Inoute, Ueno, ?4Wishids, 'fAajo, 'Rccanalizaton a-ercoil embolothnpy of pulmonaiy -arteiiovtou malfbrmations,7 study of long term 21 outcome and, mechanism for atcanalizatiour' AIR, 170:727-75%,1998..

22 Schmitz Rode, Thinmezmons, Uchida, Kichikawn, Hishida, Gunther, Rosch, t Self- 23 expandable spindle for tranucatheter vascular' occiusiou! :in. vivo 'enperiments"- 24 Radiology. 188:95-100, 1993.

Schurmanri not, '?Neoininal byerplasia in 'low-profile nitinol lants, Paimmi ftell, 26-~arnd' Walistents: -a comparative -eipedinknitsl studyr 'Cardiovas. Intenvent 27 RadioL.19:248-254,1996.

23 Schild, Mildenberge, Kealjes, "Effectiveness of platinum. wire nicrocoils for venous n9 occlusion: a study on patients treated for *nogenic Impotence,." Cardiovzsc.

Iniervenr. Radial., 17:170-172, 1994.

Z128z COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:09 FAX 01 2 9810..8200 F B RICE CO.

I Schwart, TeitelbatuM Kwrn,-Pahtecost, "EffeetiVehess "of tratiscalthete entiolzatlon. ir 2 thie control of frneptirVc vascniainjuriet,"-JVJR, 4:.3-59-365, 1993.

3 -Selby Jr., "Interventionbl, radiology of frauma'" Radio Clii.. N. Am "30:427-439. 1992.

4 Sharaffuddifi, Gu, 'Carvers Ceballos; Urea.Aplatz, ""RepositionAblc vascular 5 orcluder experimental comparison with stanadGianturco coils," NI?, 7:695 46 703,1996.

7 Sharafuddn, Cu. Titus, Sakini;, Potts, ColomaziCervera-Cebailos, Aidey'an, Amplatz, a ."Expenimqtal. evaluation oft a, new felf exjgandlng patent duwtus- artariosus g occlude: in a caiine iiiod4"? Nil, 7:817-87, 1996.' to Simonj Rabkln;Kkafhinsi, Ximj Ranai, "Cbrniparativc evaluation 'of clinically availabl; 11~~ inferior vena cava filtcis-with'an in vkrro physiologic siiriulation of the vena Cava., 12 RadioloFgyL,189-.7694774,'1993.' 13 Sormer. Guticrftoz, Lai, Fatness, "UJse of preformed. nitinol snare to improve 34 Iranscathet~r Coil delivery in *occhuuion -of patent ,ductus arteriosus," Am. J.

is Cardiol.,74:S3&839j 1994.

16 Taki, Yonelcawa. Iwta UnYtahtAel AnW liquid material for 17 emblization of arteriovenous malformationts,' AJNR, 11: 163-168, 1990.

is Teltelbatm, Reed, Laren, Lee, Pentecost, Fineck, Katz, "Microcatheter embolization of 19 non-neurologic traumatic vascular lesions," JVIR, 4:.149-154, 1993.

Terada, Nakamnura, Nakui et at., "Embolization of arteiovenous malformations with 2t peripheral aneurysms using ethylene vinyl alcohol copolymer," J. Neurosur, 22 75:655-660, 1991.

23 -Tomstzld, Arnold, Peart a: at, 'Transcathete occlusion of the patent ductus artediosus 24 with Cook detachable coils," Meant, 76:53 1-535, 1996.

Uzun, Hancock, Parsons, Dickinoon, Gibbs, wTranacatheter occlusion of the arterial duct 26 with Cook detachable coils: early experience;' Heart, 76:269-273,19"6..

27 Vedanthurn, Goodwin. McLucas, Mohr, "Uterine arty embolizatlon: an undenised 28 method of conrolling pelvic hemorrhage," Am. 1. Obsta. Gynecol-, 176:938-948, 29 1997.

Z129 COMS ID No: SMBI-00564385 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:10 FAX 61 2 9810 8200 F B RICE CO. Z~130 Vg~lye~a.,"Up'i Vesel~er t, "per ex;trmity!-qentral ve-Ynous.,qbstnactjon in hemodialysis ptetr 2treatment with Walistnt" Raily.2t43r348,199-7.

Wollace, qtaninay*,v qesantos, -Murray, Romnsdahl, .Brae1~en, -Jonsson. "Arterial 4 occhislon Of pelvic bone rumors" Cancer, 43: 32-2-328,,1979.- Wallazen,. Patent No., .4655,71l. 1987.

6 Wessel, IKcane, Parness, Lock, Outpatient closure of the patent ducus .arteiogss"# 7Cruan,716107.1?1.

a hiePolak Wijth, "Phoayarwdrvwwus .,malfonnationa: diagnosis and 9 transcatberor ombolotberapy," JYI, 7:787-804,41996. Xi an. Roy, Hons, Jrvpmebo, Laernz "Multiple emboll and filter function: An ivr 11 comparisn f three vena cpva filters," JViR, 6:887- .893, 1995., 12 Yune, "Infefior vena cava filter: Search for. an -ideal devie, Rtddiojp) 172:15-16, zubillaga, Gugl4!Im, .Viuelat.-Duckwilcc Endovaaclar occlusion, of intacranial is aneurysms with electrically detachable. coils: coneladion of anurs neck size to and treaunenh resuts,"- AJNR,15:815-820,- *994.

17, is -106- COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09

Claims (10)

1. A device comprising: a plurality of shape memory wires woven together to form a body suitable for implantation into an anatomical structure, the body having first and second ends, the shape memory wires crossing each other to form a plurality of cells and a plurality of angles, at least one of the angles being obtuse, at least one of the cells being defined by only four sides, and both ends of at least one shape memory wire being located proximate one end of the body; wherein the value of the at least one obtuse angle may be increased by axially compressing the body.

2. The device of claim 1, wherein the shape memory wires comprise nitinol.

3. The device of claim 1, wherein the shape memory wires comprise FePt, FePd or FeNiCoTi.

4. The device of claim 1, wherein the shape memory wires comprise FeNiC, FeMnSi or FeMnSiCrNi.

The device of claim 1, wherein the shape memory wires each have a diameter ranging in size from about 0.006 inches to about 0.012 inches,

6. The device of claim 1, wherein the plurality of shape memory wires includes at least 6 shape memory wires.

25372806.1 107 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:10 FAX 61 2 9810 8200 F B RICE CO. IM 132

7. The device of claim 1, wherein the body has a tubular shape with a substantially uniform diameter.

8. The device of claim 1, wherein the body has a tapered shape with a diameter that decreases from one end of the body to the other end of the body.

9. The device of claim 1, wherein the body has a generally hourglass shape. The device of claim 1, wherein the body is hand woven,. 11. The device of claim 1, wherein the body is machine woven. 12. The device of claim 1, firther comprising a graft material atached to the body. 13. The device of claim 12, wherein the graft material comprises woven polyester. 14. The device of claim 12, wherein the graft material comprises Dacron. The device of claim 12, wherein the graft material comprises polyurethane. 16. The device of claim 12, wherein the graft material comprises PTF. 25372806.1 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:10 FAX 81 2 9810 8200 FBRC o 3 F B RICE CO. 0133 17. The device of claim 12, wherein the graft material partially covers the body. 18. The device of claim 1, further comprising'. a first tube configured to accept a guide wire; and a second tube configured to fit over the first tube. 19. The device of claim 18, wherein the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is secured to the second tube. A device comprising a body suitable for implantation into an anatomical structure, the body having a first end, a second end and being defined by at least ni shape memory wires, wherein n is greater than one, the ni shape memory wires being arranged such that the body comprises a first portion, the first portion comprising a first woven portion and at least one strut, the shape memory wires of the first woven portion crossing each other to form a plurality of cells and a plurality of angles, at least one of the angles being obtuse, at least one of the cells beinlg defined by only four sides, and both ends of at least one shape memory wire being locate proximate one end of the body; wherein the value of the at least one obtuse angle may be increased by axially compressing the body. 21. The device of claim 20, wherein the shape memory wires comprise nitinol. 2S186.1 109 COMS ID No: SMBI-00564385 Received by IP Australia: Time (I-Em) 15:21 Date 2004-01-09 09/01 '04 FRI 15:11 FAX 61 2 9810 8200 F B RICE CO. Q134 22. Tihe device of claim 20, wherein the shape memory wires comprise FePt, FePd or FeNiCoTi. 23. The device of claim 20, wherein the shape memory wires comprise FeNiC, FeMnSi or FeMnSiCrNi. 24. The device of claim 20, wherein the body further comprises a second portion adjacent the first portion, the second portion comprising a second woven portion, and the second portion having n x shape memory wires, wherein x is at least one. The device of claim 20, wherein the first portion comprises a first woven portion separated from a second woven portion by multiple first struts. 26. The device of claim 25, wherein the first portion has a generally domed shape. 27. The device of claim 25, wherein the first woven portion has a generally domed shape and the multiple first struts are bent slightly so as to increase the self-anchoring capability of the body in an anatomical structure. 28. The device of claim 25, wherein the first portion further comprises a third woven portion separated from the second woven portion by multiple second struts, and wherein the first and third woven portions have generally domed shapes. 25372SOi.l 110 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:11 FAX 81 2 9810 8200 F B RICE CO. lb135 29. The device of claim 20, further comprising a graft material attached to the body. The device of claim 29, wherein the graft material comprises woven polyester. 31. The device of claim 29, wherein the graft material comprises Dacron- 32. The device of claim 29, wherein the graft material comprises polyurethane. 33. The device of claim 29, wherein the graft material comprises PTFE. 34. The device of claim 29, wherein the graft material partially covers the body. The device of claim 20, further comprising; a first tube configured to accept a guide wire; and a second tube configured to fit over the first tube. 36. The device of claim 35, wherein the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is secured to the second tube. 37. An occluding system comprising: a plurality of shape memory wires woven together to form a body useful for occluding an anatomical structure, the body having first and second ends, both ends of at least 2072886.1 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:11 FAX 61 2 9810 8200 FBRC O F B RICE CO.

10 136 one shape memory wire being located proimate one end of the body, the shape memory wires crossing echb other to forn a plurality of cells and a plurality of angles, at least one of thie angles being obtuse, and at least one of the cells being defned by only four sides; wherein the value of the at least one obtuse angle may be increased by axially compressing the body. 38, A device comprising: a body suitable for implantation into an anatomical structure, the body having an axis, a first end and a second end, wherein the body comprises a shape memory wire having a first segment and a second segment, the segments being separated by a bend in the shape memory wire located proimnate one end of the body, the first segment extending helically in a first direction around the axs toward the other end of the body, the second segment extending helically in a second direction around the axis toward the other end of the body, the first and second segments crossing each other in a plurality of locations, and the first and second segments alternating being farther from the axis at each location. 39. A device comprising: a body suitable for implantation into an anatomical structure, the body having a first end and a second end, wherein the body comprises a shape memory wi-re having a first segment and a second segment, the segments being separated by a bend in the wire located proximate one end of the body, the first segment and second 29572"061 112 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:11 FAI 61 2 9810 8200 F B RICE CO. [2137 segments being arranged to form loops and twisted segments such that at least two contiguous loops are separated from another loop by a twisted segment. A device comprising: a body suitable for implantation into an anatomical structure, the body having two ends and comprising a shape memory wire having a first segment and a second segment, the segmenlts being separated by a bend in the wire located proximate one end of the body, the segments being secured to each other in loop-defining locations, the segments also extending between the loop-defining locations in spaced relation to each other so as form at least two loops, at least one of the at least two loops having a compressed shape. 41. A device comprising: a plurality of shape memory wires woven together to form a body suitable for implantation into an anatomical structure, the body having a first end, a second end, and an intersection of two shape memory wires crossed in non-interlocking fashion; where both ends of at least one shape memory wire arc located proximate one end of the body, and the two crossed wires form an obtuse angle that may be increased by axially compressing the body. 42. The device of claim 41, where the shape memory wires comprise nitinol. 2537206.1 113 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:12 FAX 61 2 9810 8200 F B RICE CO. [a 8 43. The device of claim 41, where the shape memory wires comprise FePt FePd or FeNiCoTi. 44. The device of claim 41, where the shape memory wires comprise FeNiC, FcMnSi or FcMnSiCrNi. The device of claim 41, where the shape memory wires each have a diameter ranging in size from about 0.006 inches to about 0.012 inches. 46. The device of claim 41, where the plurality of shape memory wires includes at least 6 shape memory wires. 47. The device of claim 41, where the body has a tubular shape with a substantially uniform diameter. 48. The device of claim 41, where the body has a tapered shape with a diameter that decreases from one end of the body to the other end of the body. 49. The device of claim 41, where the body has a generally hourglass shape. The device of claim 41, where the body is hand woven. 51. The device of claimn 41, where the body is machine woven. 2q37=86.1 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:12 FAX 61 2 9810 8200 F B RICE CO. 1039 52. The device of claim 41, fluther comprising a graft material attached to the body. 53. The device of claim 52, where the graft material comprises woven polyester. 54. The device of claim 52, where the graft material comprises DacOr The device of claim 52, where the graft material comprises polyurethane. 56. The device of claim 52, where the graft material comprises PTFE. 57. The device of claim 52, where the graft material partially covers the body. 58. The device of claim 41, further comprising: a first tube configured to accept a guide wire; and a second tube configured to fit over the first tube. 59. The device of claim 58, where the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is secured to the second tube. A device comprising: a plurality of shape memory wires woven together to form a body suitable for implantation into an anatomical structure, the body having a first end, a second 253729MIl COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:12 FAX 61 2 9810 8200 F B RICE CO. end, a middle, and an intersection of two shape memory wires crossed in non- interlocking fashion; where both ends of at least one shape memory wire are located nearer one end of the body than the middle, and the two crossed wires form an obtuse angle that may be increased by axially compressing the body. 61. The device of claim 60, where the shape memory wires comprise nitinol. 62. The device of claim 60, where the shape memory wires comprise FePt, FcPd or FeNiCoTi. 63. The device of claim 60, where the shape memory wires comprise FeNiC, FeMnSi or FeMnSiCrNi. 64. The device of claim 60, where the shape memory wires each have a diameter ranging in size from about 0.006 inches to about 0.012 inches. The device of claim 60, where the plurality of shape memory wires includes at least 6 shape memory wires. 66. The device of claim 60, where the body has a tubular shape with a substantially uniform diameter. 253711061 116 IM 140 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:12 FAX 61 2 9810 8200 F B RICE CO. [141 67. The device of claim 60, where the body has a tapered shape with a diameter that decreases from one end of the body to the other end of the body. 68. The device of claim 60, where the body has a generally hourglass shape. 69. The device of claim 60, where the body is hand woven. The device of claim 60, where the body is machine woven. 71. The device of claim 60, further comprising a graft material attached to the body. 72. The device of claim 71, where the graft material comprises woven polyester. 73. The device of claim 71, where the graft material comprises Dacron. 74. The device of claim 71, where the graft material comprises polyurethane. The device of claim 71, where the graft material comprises PTFE. 76. The device of claim 71, where the graft material partially covers the body. 77. The device of claim 60, flirther comprising: a first tube configured to accept a guide wire; and 2537MM.I COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 09/01 '04 FRI 15:13 FAX 61 2 9810 8200 F B RICE CO. 1142 a second tube configured to fit over the first tube. 78. The device of claim 77, where the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is secured to the second tube. 79. A method of creating a body suitable for implantation into an anatomical structure, the body having two ends, the method comprising: providing a weaving system comprising: a template having first template projections; bending shape memory wires around the first template projections to create bent portions in the shape memory wires, the bent portions being arranged to define one end of the body, each shape memory wire having two ends; and weaving the ends of the shape memory wires around the template to create the body such that the shape memory wires cross each other in non-interlocking fashion to form a plurality of angles, at least one of the angles being obtuse; where the value of the at least one obtuse angle may be increased by axially compressing the body. The method of claim 79, where the first template projections comprise tabs. 81. The method of claim 79, where the first template projections comprise pius. 82. The method of claim 81, where the pins are attached to a ring engaged with the template. 253M206.1 s18 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09 ~i143 09/01 '04 FRI 15:13 FAX 61 2 9810 8200 F B RICE CO. 83. The method of claim 79, where the weaving system further comprises a first weaving plate configured to rotate in a first direction during the weaving. 84. The method of claim 83, where the weaving system further comprises first bobbins arranged on the first weaving plate, one end of each shape memory wire being attached to each first bobbin prior to the weaving. The method of claim 83, where the weaving system further comprises a second weaving plate configured to rotate in a second direction during the weaving, the second weaving plate being spaced apart from the first weaving plate. 86. The method of claim 85, where the weaving system further comprises second bobbins arranged on the second weaving plate, one end of each shape memory wire being attached to each second bobbin prior to the weaving. 87. The method of claim 79. further comprising securing the shape nmemnory wires to the template. 88. The method of claim 79, further comprising forming closed structures with the ends of the shape memory wires, the closed structures being aranged to define the other end of the body. 89. The method of claim 79, further comprising heating the body and the template. 25372386.1 '119 ia143 COMS ID No: SMBI-00564365 Received by IP Australia: Time 15:21 Date 2004-01-09