2) United States Patent Becher et al. (Sa) STENT (75) Inveators: Baerbel Becher, Rostock (DE); Carsten, “Momma, Rostock (DE) BIOTRONIK SE & Co. KG, Berlin wry (73) Assignee (*) Notice: Subject to any disclaimer, the term of this pateat is extended of adjusted under 35 USC. 154(b) by 870 days, Appl.No: 10/882,893 PCT Filed: Apr. 5, 2004 PCTNo: PCT/EP2004/003630 $371 (4), (2),(4)Date: Now. 10, 2006 (87) PCT Pub, Nos WO2004/089247 PCT Pu, Date: Oct. 21, 2004 6s) Prior Publication Data US 200710168015 Al Jul. 19, 2007 G0) Forcign Application Priority Data Apr. 10,2003 (DE) 103.17 241 (201301) 623/119; 6231.2; 629/1.34 evid ) Field of Classification Seareh spc’ 428/195.1; 628/1.1-1.46 application file for complete search history. $008728611B2, (10) Patent No. 4s) Date of Patent: US 8,728,611 B2 May 20, 2014 66) References Cited US. PATENT DOCUMENTS S80051 A * 911908 Mayer ovis SOIL6 A 71999 nmin S078 A 62000 Casio ctal 898782 BL 22001 ‘Hebron | 241601 BL 62001. emer eta 6312486 BL 112001. Keane. S398806 BL 62002 You Sa7i721 BL 102002 Dang 2001001317 AL "$2001. Daetig ta. FOREIGN PATENT DOCUMENTS De 0729279 AL i999 DE 0064596 AL 62002 Wo woodaries Lig WO Woonesea Be WO WODLASSTS a2 6 2001 Wo WonvaeMo AL 2001 WO WOOD 22K AL 4 2002 wo Woo $2002 * cited by examiner Primary Examiner —G rar Higgins (4) Attornes, Agent, or Firm — Greet, Burns & Crain, id on ABSTRACT A stent comprises a metallic, relatively radiolucent carrier structure and at least one marker element which inelndes ‘comparatively radiopaque material. The radiopaque material is completely enclosed by a cover layer of msterial other ‘than the radiopaque material, the eover layer inching metal ‘ora metal compound. The stent may be used to tea a patient. 13 Claims, 4 Drawing SheetsU.S. Patent May 20, 2014 Sheet 2 of 4 US 8,728,611 B2U.S. Patent May 20, 2014 Sheet 3 of 4 US 8,728,611 B2 30 sf a TWO Fig, AS 32 SNU.S, Patent May 20,2014 Sheet 4 of 4US 8,728,611 B2 1 STENT BACKGROUND OF THE INVENTION “The invention concerns a stent having a metalic relatively radiolucent cari stricture and a least one marr element ‘comprising comparatively radiopaque material Stents are endovascular prostheses which serve inter aia forthe treatment of stenoses, that i to say, vessel constric- tions. Stents usually have a tubular cartier structure which is ‘open at both Fongitudinal ends ofthe tube and which formed, by legs and openings enclosed by the legs. Stents ofthat kind ‘can usually assume two conditions, more specifically a com- pressed condition of small diameter and an expanded con- dition of s comparntively lager diameter. Inthe compressed ‘condition, such a stent ean be introduced by means of a ‘catheter into for example blood vessel and ean bepositioned ‘ata location tobe treated. The stent is expanded ois allowed, {© expand ofits own aevord, atthe treatment location. Stent which are not sell-expanding are usually expanded! by means ‘ofan iilatahle balloon a a distal end oF a eatheer for inser tion thestent, Stents ofthat kind are therefore referred tos bulloon-expanded. Other stents have the property of expand- ing oftheir own accord, for example by virtue of inherent spring forces. Stents of that kind are referred to as sell- ‘expanding. ‘The sell-expanding stents include in particular those which have a carrer structure comprising a shape ‘memory metal sue a nitinol, a known titanium nickel come pound. Shape memory metals ofthat kind have the property ‘of retaining a first shope or being plastically deformable below a given change temperature, and assuming a second shape when the change temperature is excecde. In regard to stents, shape memory metals are used in such a way thatthe first shape correspon tothe compressed condition ofa stent snd the second shape eotresponds fo the expanded condition ofa stent Inthe expanded condition ofa stat, itserves, for example, forthe weatment of vessel consrictions (stenoses), acting as ‘a essel support which keeps a blood vessel to be treated open, ‘ata constricted locaton. The expanded stent ats in opposi- tion to the vessel constriction and supports the vessel wall ia the region ofthe vessel constriction. For that pugpose, the sent must enjoy adequate radial strength or carrying force. “The cartier sinicture ofthe stomt must also afford adoquate surface coverage in order adequately to support the vessel ‘constrietion. On the other hand, the requirement for being ‘able to expand the stent means that openings are necessarily present between the legs ofthe carrier structure ofa stent. Ia the compressed condition of the stent, those openings ean be substantially closed. Inthe expands! condition ofthe stent the opening is enlarged in any cave Besides an adequate carrying force, stents must also Jnvolve adequate flexibility with respect to their longitudinal xis in order to beable to follow movements ofthe vessel. In ‘addition there isa wish for longitudinal changes in a stent "upon expansion to be kept as small as possible. Finally the lateral ofthe stetorat leat the sufacethereo! shou beas body-compatible ss possible. “Those requirements have ested in vatious, very sophiss ticatod and diversified stent configurations. The stents which ‘are of interest here have a cai stactue produced from 8 ‘etal sube asthe starting material. Cting the metal tae for ‘example by means of a laser or spark erosion produces the legs, as remaining material. Cut legs of that kind have the reat advantage over sents ofthe first generation, which were 0 o 2 shaped from wire, thatthe geometry of the earier structure ‘canbe optimized in regard the various different demands involved That large number of demands made on stents further includes the requirement that the stent is ta be capable of being positioned with the utmost accureey. In genera, the ‘operation of positioning a stent is effected by means of imag- ing processes which, for example, operate with X-rays Inthis connection, there i zenerlly the disadvantage that materials ‘which are suitable forthe carrer structure of a stent fe- «quently can only be detected with difficulty by means ofthe Imaging processes used as the material forming the carrer Structure is relatively radiolucent, ICs therefore known t0 provide stents with what are referred to as Xeniy markers containing a relatively radiopaque material which is easy 10 Jocate by means ofthe above-specified imaging processes. A known radiopaque material is lor example, gold ‘Usually, the need to provide X-ray markers in stents of the above-deseribed kind forces compromises in terms of the Stent design, which are posibly detrimental to atbers ofthe abovesmentioned desired! properties, "An aspect of the present invention is to provide a stent whieh is X-ray visible and which monover combines together as many as possible of the desirable properties. BRIEF SUMMARY OF THE INVENTION In accordance with the invention, that object is attained by stent ofthe kind set forth inthe opening part of this spec fication, wherein after the cutting-out operation, the marker clement (22) s welded to the rest of the earicrstctire (12 16) aad the radionague material is completely enclosed by a cover layer of a material other than the radiopaque material, the cover layer including metal ora metal compound, ‘he invention is based on the basic idea of integrating radiopaque material as an Xcray murker for a sfent into the carrer siicture of the stent in sch a way thatthe outwardly acting surface ofthe stent inthe region ofthe X-ray marker is ‘ot chanicterized by the radiopaque material but by another ‘metal ora metal compound. The metal ofthe cover layer of the marker clement advantageously makes it possible forthe ‘marker element to be welded tothe rest ofthe career stuctnre after it has boon cutout. The outwardly acting surface of the X-ray’ marker i that ease can be for example of a body ‘compatible nature by virtue ofa silicon carbide coating. In a particularly avantageons variant, the metal forming the cover layer isidentical tothe metal ofthe carier structure and can therefore be easily connected tothe rest ofthe carrier structure by welding without eontact corrosion or the Tike ‘curring. The last-mentioned property is particularly advantageous jn connection with a stent having a sell-expanding carrier structure, for example, comprising a shape memory metal stich as nitinol In that aso, itis possble fr the X-ray marker to be provided inthe form of a hollow nitinol wire which is filled in the interior with goldand which isto be easily welded to the rest ofthe carrer stracture ofthe stent. In that Way the “X-ray marker can even be integrated into the carrer structure Tn prefered variants, a ste ofthat kind, in particular 3 solf-expansing nitinol stent of that kind, i deug-coated. Sui able drugs contsin active substances with inflammation in- hibiting and proiferation- inhibiting effect. Such active sub- ances are for example Sartane or eyclospurin A which are joined to the carrier siracture of the stent by means of a polymer carrier matrix. After implantation ofthe stent, the Active substance or substances ean elute into the body tissue ‘and deploy their desire inflanmation-inhibiting or proliferUS 8,728,611 B2 3 tion-inhibiting effect. The active substances can thus eontib- ute avoiding unwanted fe-stenosis or uawanted inflamma BRIEP DESCRIPTION OP THE SEVERAL VIEWS OF THE DRAWINGS. ‘The invention will now be described by means of embod ‘ments by way ofexample with reference othe accompanying Figures in whic TIG. 1 isa diagrammatic view ofa stent FIG. 2 shows an example of a development ofthe carrie structure of a stent, whieh forms a stent peripheral wall; TIG, 3 shows a view in crostsoction through leg portion Jorming an X-ray marker for sents shown in FIGS. 1 and and FIG. 4 shows an alternative configuration © FIG. 1 DETAILED DESCRIPTION OF THE INVENTION “The tent 10 shown in FIG. Lis inthe form ofhollow body which is open at its ends and the peripheral wall of which is Tormed by acarricr structure with patinly folded legs 12. The legs 12 form support portions 14 Which are each Formed by @ respective leg whichis closed in an annular configuration in the peripheral direction and which is folded in a zigzage shape! or meander-shaped com ‘The stent 10 is formed by a plurality of such support por. tions 14 which occur in succession in the longitudinal diree- tion, The support portions of Teg rings 14 are connected together by way of connecting legs 16. Fach two connecting Jegs which are mutually adjacent inthe peripheral direction and the parts, which are in mutually oppeste relationship between those connecting leps 16, of the ley rings or support portions 14 define « mesh 18 of the stent 10, Such a mest 18 represents an opening in the carrier structure or peripheral ‘wall of the stent 10. A corresponding mesh 18 is shown ‘emphasized in FIG. 1. “The number of leg rings or support portions 14 and the Jength 1 thereon elation tothe otal length Lo te stent 10 dependson the purpose of sco the stent Coronary stents are usually ofa shorter overall length Land have a smaller ume ber of support portions 1 “The support portions 14 arranged at the eo longitudinal ‘ends ofthe stent 10 form end portions 20 ofthe sent. The ‘annulaey elosed, zigzag-foldot legs which form the end clo= ‘ure portions 20 are provided in portion-vise manner with marker elements 22. While the legs 12 and 16 ofthe stent 10 ‘re preferably made froma nitinol ube as starting material by ‘cutting it out by means of a laser of by spark erosion, the ‘marker clements 22 are subsequently welded to the legs 12 or tat purpose in the case of the example shown in FIG. 1. in production ofthe earier structure by euling out the legs 12 and 16 from a nitinol tube, corresponding apertures are provided, into which the marker elements 22 are later welded. ‘As an alternative there, itis also possible forthe end portions 20 o be produced independently of the rest of the ‘carter structure ofthe stent 10 and to be prefabricated, for ‘example completely fom nitinol wire, forexample one with a gold cow. In that case, the entire end portions 20 respec- tively forma continuous X-ray marker which, after the opera- tion of eutting out the rest of the eater structure from nitinol tube, i cannected to the omtermost connecting legs 24 by welding, That variant isnot specially shown in FIG. Las the only difference in relation to the illustration in FIG. 1 is thatthe entire end portion 20 forms a continuous marker ‘element 22, 0 o 4 4 further variant, one or more individual marker ele- smeals are welded to the earrier structure of a stent 10,25 is show ia FIG. 1. This variants shown in FIG. 4. Accordingly, the entire carrer stricture of the stent including the end portions 20 is cutout ofa nitinol tube and only the marker clements 22! are subsequently welded otha carrer sre "As can be seen ftom the cross-section through an X-ray smarker22.nd22' respectively in FIG-3, its famed by awire ‘30 whieh, in its interior inclades a core 32 of X-ray-opaque ‘material such as for example gold, platinum or palladium. ‘That core 32 is completely enclosed by easier materia 34, In that respect, the carrer material 34 corresponds to the mal- Ji material from which te rest of the stent 10 i proveed. A preferred carrier material is nitinol, a titanium nickel alloy ‘whieh is also refered to as a shape memory metal. The advantage of such an X-ray marker is that it ean be readily joined to theest ofthe carrier structareof stent, for example bby welding. without the per se known problems such as ran sition or contact corrosion occurring. That is of great signifi ‘ance, in particular i the ease of sel-expanding stents com prising a shape memory metal such nitinol Shape memory metals such a nitinol are preferably used {for slf-expanding stents. The particularity of such a shape remory mica stati can assume two shape conditions and it makes a transition from the first shape condition into the second stable shape condition when a change temperature is ‘exceeded. In regard to stents, the fist shape condition orre- sponkl othe compressed condition ofthe stent in which tis ‘ntrociced for example into a blood vessel or is ited onto a stent delivery catheter, When the change temperatuee is raced, the stent has a tendency to assume its expanded cconciton and develops corresponding expansion. forces hich have the desired, vessels supporting elec. In that way the stent possibly does not need 10 be expanded and plast- cally deformed by means of a balloon. The advantages and preferred design variants of sel-expanding stents, in partien- lar of shape memory metals such as nitinol, are basically Known to the person skilled in the art, The advantage of a ‘marker clement of the kind described herein is that this ‘marker element ean basically be combined! with all known forms of self-expanding stents, in particular also those of nitinol, without corrosion problems occurring in stats, We claim: 1, stent having a metalic, atleast partially radiolucent carrer structure comprising @ cut out meal ube ineluding Jes defining a mesh, and having atleast one marker element welded tot Teast one leg wherein prior to being welded, the ‘marker element is formed as inchiding a unitary core of @ comparatively radiopaque material filling the interior and completely enclosed by’ a unitary cover layer of a metal or ‘ictal compound including material other than the compare tively radiopaque material, and together the comparatively radiopaque material and the unitary cover layer form a core filled wire, wherein the metal oF metal compound in the unitary cover layer includes a titanium nickel alloy, and ‘wherein the metal forming the carrier structure isthe same ‘itanium niekel alloy included inthe unitary cover layer. 2. The steat as set forth in claim 1, wherein the carrier structure i a se-expanding cartier stricture '3. The steat a6 set forth in claim 2, wherein the carrier structure inchdes a shape memory metal which changes its shape at a change temperature, wherein the stent is of soch @ ‘design configuration that the stent retains 2 compressed con- tition below the change temperature and assumes an ‘expanded condition above the change temperate, “4 The stent as sct forth in claim 1, wherein the unitary cover layer further comprises silicon carbide (SiC) coating,US 8,728,611 B2 5 5. The sen as st forth in elim 1, wherein the marker clement is attached to thecaerstocture athe unitary cover Inver. "6: The sent asset forth in claim 1, wherein the marker clement isaac o the carir siti in region of Jongitdinal end ofthe sent “The set as forth claim 1, wherein the compare sve radiopage meri contin od, platinum and pals ium, 2 The stent asset forth in eu 1, wherein the caer structure includes at least one aperture’ preuced by cutting ‘tat ess ono thc legs and wherein te at east one marker ‘leet welded in the teat one aperture. 9 Thestent asset forth inclaim , wheeinaplraity of the dogs fora east one leg in. 10, Thestent as et forth inelim 9, wherein the at east one deg to which the atleast one marker element i welded is a memberofthe plurality ofthe legs foming heat east one leg ring. 1H. The tents set frthinelsim9, wherein theat least one amar element fos a end portion, 12. A method of testing a patient, the method comprising implaningaselF-expanding tent intothe paint, wherein dhe 6 stent comprises a metalic, a least patally ado translucen carrer structure comprising «cut out metal tube at least partially of tianium-nickel alloy ineluding legs defining a ‘mesh and at least one marker element welded to a least one Jeg, and wherein the atleast one marker element includes unitary core of a comparatively radiopaque material filling the interior and completely enclosed by a unitary cover layer ‘of a meta or metal compound materia other than the radio~ aque material, wherein the unitary cover includes the itr jum-nickelalloy and togetherthe comparatively radiopaque ‘material and the unitary cover layer form a core filled wir, and prior to implanting the stent into the patient, forming the stent by cutting the carrer structure out of a ube, form- ing the at least one marker element with the unitary core ‘and the unitary eover layer, andl then welding the a least ‘one marker element tothe atleast one leg of the carrier stevetre 13, The stent of ela carbide (SIC) coating 12, further comprising a silicon