(12) Patent Application Publication (10) Pub. No.: US 2010/ A1

Transcription

1 (19) United State US 2010O A1 (12) Patent Application Publication (10) Pub. No.: US 2010/ A1 Quadri et al. (43) Pub. Date: Nov. 25, 2010 (54) VASCULAR IMPLANT AND DELIVERY SYSTEM (76) Inventor: Arhad Quadri, Wet Hartford, CT (US); J. Brent Ratz, Ladera Ranch, CA (US) Correpondence Addre: KNOBBE MARTENS OLSON & BEAR LLP 2040 MAINSTREET, FOURTEENTH FLOOR IRVINE, CA (US) (21) Appl. No.: 12/761,349 (22) Filed: Apr. 15, 2010 Related U.S. Application Data (60) Proviional application No. 61/169,367, filed on Apr. 15, Publication Claification (51) Int. Cl. A6IF 2/24 ( ) (52) U.S. Cl A2.11 (57) ABSTRACT A vacular implant for replacing a native heart valve com prie a elf expanding tent Supporting a valve body having leaflet. The tent preferably comprie an anchoring truc ture configured to prevent the implant from paing through the valve annulu. For delivery, the implant i compacted within a delivery device and ecured at one end. During delivery the implant i partially releaed from the delivery device, and poitioning of the implant i verified prior to full releae. The implant can be at leat partially reheathed and repoitioned if deired. ///7

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28 US 2010/ A1 Nov. 25, 2010 VASCULAR MPLANT AND DELIVERY SYSTEM CROSS-REFERENCE TO RELATED APPLICATIONS Thi application claim priority to U.S. Proviional Application Ser. No. 61/169,367, which wa filed on Apr. 15, The entirety of the Priority Application i hereby incor porated by reference. More particularly, paragraph and ) and FIGS are incorporated by reference in connection with Stent frame tructure, and paragraph and and FIGS are incorporated by reference in connection with deliv ery ytem. BACKGROUND Field of the Invention The preent invention relate to replacement heart valve and ytem for delivering replacement heart valve Decription of the Related Art 0005 Human heart valve, which include the aortic, pull monary, mitral and tricupid valve, function eentially a one-way valve operating in Synchronization with the pump ing heart. The valve allow blood to flow in a downtream direction, but blockblood from flowing in an uptream direc tion. Dieaed heart valve exhibit impairment uch a nar rowing of the valve or regurgitation. Such impairment reduce the heart' blood-pumping efficiency and can be a debilitating and life threatening condition. For example, valve inufficiency can lead to condition uch a heart hyper trophy and dilation of the ventricle. Thu, extenive effort have been made to develop method and apparatu to repair or replace impaired heart Valve Prothee exit to correct problem aociated with impaired heart valve. For example, mechanical and tiue baed heart valve prothee can be ued to replace impaired native heart valve. More recently, ubtantial effort ha been dedicated to developing replacement heart Valve, particu larly tiue-baed replacement heart valve, that can be deliv ered with le trauma to the patient than through open heart Surgery. Replacement valve are being deigned to be deliv ered through minimally invaive procedure and even percu taneou procedure. Such replacement valve often include a tiue-baed valve body that i connected to an expandable tent that i then delivered to the native valve' annulu Development of replacement heart valve and ao ciated delivery ytem in which the heart valve i compacted for delivery and then controllably expanded for controlled placement ha proven to be particularly challenging. Delivery ytem that facilitate accurate poitioning and reliable place ment have alo proven to be challenging to develop, particu larly ytem that enable repoitioning of the valve after par tial deployment if it i determined that the valve i not poitioned correctly. SUMMARY 0008 Accordingly, there i in the need of the art for an improved replacement heart valve and an improved ytem for delivering uch heart valve in a reliable and controlled a In accordance with one embodiment, the preent invention provide a method of loading a device for delivering a elf-expanding vacular implant. The method may include drawing a relaxed, expanded vacular implant through an elongate form having a decreaing diameter to a load tube portion having a compacted diameter, engaging a locking end of the implant with a locking mechanim dipoed on a Sup port tube, advancing an outer heath over the engagedlocking end and Support tube o a to capture the locking end between the heath and Support tube, and advancing the outer heath over the compacted implant o a to tranfer the implant from within the load tube to within the outer heath In one uch embodiment, tranferring the implant from within the load tube to within the outer heath comprie further compacting the implant In accordance with another embodiment, the preent invention provide a vacular implant delivery device. The device comprie an elongate Support tubehaving a dital end, a locking mechanim being dipoed at or adjacent the dital end. An elongate heath i adapted to lide over the Support tube. A elf-expanding vacular implantha a locking member. The Support tube locking mechanim i configured to engage the implant locking member o a to block axial movement of the implant when the locking mechanim and locking member are engaged. The heath ha an inner lumen ized to block the implant locking member from moving radially relative to the Support tube locking mechanim Suf ficient to releae from the Support tube locking mechanim In one uch embodiment, the elf-expanding vacu lar implant remain connected to the Support tube o long a the heath extend ditally pat the Support tube locking mechanim, and the device i configured o that when the heath i moved proximally pat the Support tube locking mechanim, the implant locking member move radially out of engagement with the Support tube In accordance with yet another embodiment, the preent invention provide a method of delivering a elf expanding vacular implant. The method may include advancing the implant within a patient' vaculature to a deired delivery location, the implant being advanced while maintained in a compacted configuration within a heath, a firt end of the implant being captured between the heath and a Support tube locking mechanim. The method further include withdrawing the heath proximally ufficient to enable a econd end of the elf-expanding implant to expand radially to a fully expanded ize while the firt end of the implant remain captured. The econd end of the implant i poitioned in a deired poition and orientation while the firt end of the implant remain captured. The method further include withdrawing the heath proximally ufficient to releae the firt end of the implant In once uch embodiment, if it i determined that the econd end of the implant i not poitioned a deired, the method additionally comprie moving the heat ditally o a to at leat partially recapture the implant within the heath, repoitioning the delivery device, and again withdrawing the heath proximally ufficient to enable the econd end of the implant to expand radially Other inventive embodiment and feature are di cloed below. BRIEF DESCRIPTION OF THE DRAWINGS 0016 FIG. 1 i a perpective view of a heart valve implant having feature in accordance with one embodiment FIG. 2A i a plan view of a tent frame of the implant of FIG. 1 in a radially compacted configuration.

29 US 2010/ A1 Nov. 25, FIG. 2B how the tent frame of FIG. 2A in a radially expanded configuration FIG. 3 chematically how an implant a in FIGS. 1-2 deployed in a native mitral annulu of a human heart FIG. 4 i a plan view of a tent frame configured in accordance with another embodiment FIG. 5 how a flat cutting pattern for a tent frame a in FIG FIG. 6 how a plan view of a tent frame in accor dance with yet another embodiment FIG. 7 i a plan view of a tent frame configured in accordance with till another embodiment FIG. 8 i a plan view of a tent frame configured in accordance with yet a further embodiment FIGS. 9A-E how exemplary embodiment of anchor portion for ue with tent frame embodiment a dicued herein FIGS. 10A-D how exemplary embodiment of anchor tip portion for ue with Stent frame embodiment a dicued herein FIG. 11A how an embodiment of a delivery device for delivering a valve implant in accordance with one embodi ment FIG. 11B how a dital portion of the delivery device of FIG. 11A FIGS. 12A-I how a ditalendofa delivery device at everal tage during a delivery operation in accordance with a preferred embodiment FIGS. 13 A-C how the delivery device of FIGS. 12A-I at elected Stage of the deployment operation in con nection with a human heart FIGS. 14A-L how an embodiment of a delivery device and an embodiment of a tructure for loading an implant onto the delivery device, hown at everal tage during a loading operation FIGS. 15A-H how another embodiment of a load ing device and aociated method hown at everal tage during the operation of loading an implant onto a delivery device FIGS. 16A and 16B how an embodiment of a multi-piece loading device in an aembled and a dia embled configuration FIGS. 17A-F how another embodiment of a deliv ery device and an embodiment of a tructure for loading an implant onto Such a delivery device, hown at elected Stage during a loading operation. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The preent pecification and drawing dicloe apect and feature of the invention in the context of embodi ment of replacement heart valve and delivery ytem for delivering replacement heart valve. For illutrative purpoe the embodiment dicloed herein are dicued in connec tion with replacing the patient mitral valve. However, it i to be undertood that the context of a particular valve or particu lar feature of a valve hould not be taken a limiting, and feature of any embodiment dicued herein can be employed in connection with prothee and delivery ytem for replacing other vacular valve, and feature of any embodiment can be combined with feature of other embodi ment a deired and when appropriate With initial reference to FIGS. 1 and 2, an embodi ment of a replacement heart valve 28 comprie a valve body 30 attached to a tent frame 40. In thi embodiment, the heart valve body 30 i contructed of a tiue-baed media uch a bovine, equine and/or porcine pericardium. Vacular tiue, a well a other natural and manmade material that are thin, flexible and durable, may alo be employed for the heart valve body With particular reference to FIGS. 2A and 2B, the illutrated tent frame 40 embodiment upport the valve body 30 and can be expanded from a compacted tate a hown in FIG. 2A to an expanded tate a hown in FIG. 2B. The illutrated tent 40 preferably i a elf-expanding tent contructed of a flexible material, preferably a hape memory material Such a initinol. A it i elf-expanding, the tent 40 i in a fully opened tate, a depicted in FIG. 2B, when relaxed. The illutrated tent 40 preferably i elongate from a firt end 42 to a econd end 44 and i tubular with a longitudinal axi 46 and a generally circular cro ection. It i to be undertood that in other embodiment tent can have a non-circular cro ection, uch a a D-hape, an oval or an otherwie ovoid cro-ectional hape The illutrated tent frame 40 ha a non-forehort ening portion 50 and a forehortening portion 60. The por tion are joined at a tranition 62 between the firt and econd end 42, 44. Forehortening refer to a behavior in which the length of the tent 40 in the forehortening portion 60 decreae a the radiu of the tent increae from the com pacted State to the expanded, deployed State. A uch, in FIG. 2A, which how the tent frame 40 in a compacted tate, the forehortening portion 60 of the tent frame 40 i longer than when the tent i in the expanded tate illutrated in FIG.2B With continued reference to FIG. 2B, the non-fore hortening portion 50 of the illutrated tent 40 comprie a plurality of row or ring 64a-c of circumferentially expan ible element, or trut 65, arranged in a ZigZag pattern. The Strut 65 are configured to expand and contract with a change in radiu of the tent 40. In the illutrated embodiment, the tent ha three Such ring 64a-c. It i to be undertood that more or fewer ring can be employed a deired to accomplih the purpoe of thi tent frame In the illutrated embodiment, the repective end of each circumferential undulating trut 65 join an adjacent Strut 65 at an apex 66, 68 which i, in at leat ome embodiment, an area of preferential bending. In the illutrated embodi ment, the ZigZag pattern of the ring 64a-c are generally in phae with one another. It i to be undertood that, in other embodiment, all or mot of the ring can be in phae with one another or out of phae a deired With continued reference to FIG. 2B, longitudinal trut 70 extend tranverely acro the ring 64a-c of the nonforehortening portion 50 from the firt end 42 of the frame 40 to the tranition 62. More particularly, each ring 64 hare a common longitudinal trut 70. The longitudinal trut 70 extend through apice 66 of adjacent ring 64, and preferably extend the entire length of the nonforehortening portion 50. Preferably, the longitudinal trut 70 comprie a nonexpandable rod or bar. The apice 66 that are connected to the longitudinal trut 70 are referred to a connected' api ce 66. Apice 68 not connected to longitudinal trut 70 are referred to a free apice A noted above, the longitudinal trut 70 are not Subtantially expandable in a longitudinal direction. A uch, even though the undulating trut 65 provide flexibility in radial expanion or compaction, a the tent 40 change radial ize between the compacted and expanded State, the longi

30 US 2010/ A1 Nov. 25, 2010 tudinal length of the tent in the nonforehortening portion 50 remain Subtantially unchanged. In other embodiment, the longitudinal trut may include expanible element that may allow the trut to expand omewhat longitudinally. However, Such longitudinal expanion would not be directly tied to any change in Strut radiu In the illutrated embodiment, a firt ring 64a i dipoed adjacent the firt end 42 of the tent and a econd ring 64b i dipoed adjacent the firt ring 64a. A et of firt eyelet 72 i formed at the connected apice 66 of the econd ring 64b. A et of econd eyelet 74 i alo formed at the econd end of each longitudinal trut 70, which in the illu trated embodiment i alo at the tranition 62. In a third ring 64c, the free apice 68 each comprie a protuberance 80 extending therefrom, which protuberance can alo be referred to a an apical anchor 80. Preferably the apical anchor 80 terminate at a tip 82. Preferably the trut 65 in the third ring 64c are pre-haped o a to flare radially outwardly when the tent frame 40 i in an expanded tate a hown in FIGS. 1 and With continued reference to FIGS. 2A and 2B, the forehortening portion 60 of the illutrated tent frame 40 comprie a ring 84 of generally diamond-haped cell 86 connected to one another at connector 88. A firt end of each cell 86 i connected to the nonforehortening portion 50 at the econd eyelet 74. The hape of the forehortening cell 86 i uch that a the tent frame 40 i radially compacted, the forehortening portion 60 of the tent become longitudinally longer and, correpondingly, when the tent frame 40 i expanded radially, the forehortening portion 60 horten A econd end of each cell 86 in the forehortening portion 60 define the econd end 44 of the tent 40 and alo define a bae of an end anchor 90 that extend generally radially outwardly and toward the firt end 42 of the tent. An anchor eyelet 92 i formed in each end anchor 90, preferably between the bae and a tip 94 of each anchor A firt ditance i defined between the tip 82, 94 of oppoing apical and endanchor 80,90 when the tent 40 i in the compacted State, and a econd ditance i defined between the tip 82, 94 of oppoing anchor 80, 90 when the tent 40 i in the expanded tate. A hown, the econd ditance i Subtantially le than the firt ditance. A uch, due to lon gitudinal hortening of the forehortening portion 60, the anchor cooperate to grap onto tiue o a to hold the tent in place In preferred embodiment, the tent 40 may be deployed into a heart Valve annulu, and poitioned when compacted o that the tip 82, 94 of the oppoing anchor 80, 90 are dipoed on oppoite ide of the native annulu. A the tent i expanded, the oppoing anchor are drawn cloer together o a to grap oppoite ide of the native annulu and ecurely hold the tent in poition. A uch, the tent can be held ecurely in poition without requiring a ubtantial radial force againt the native annulu Applicant' copending U.S. patent application Ser. No. 12/084,586, which wa publihed on Aug. 27, 2009 a U.S. Publication No. 2009/ , dicue embodiment of forehortening tent with anchor, and can be referred to for further dicuion of certain apect of the illutrated tent embodiment. The dicuion in thi copending application concerning tructure and operation of embodiment of a fore hortening tent, particularly a forehortening tent having anchor, i exprely incorporated by reference herein Applicant' copending U.S. patent application Ser. No. 12/569,856, which wa publihed on Apr. 1, 2010 a U.S. Publication No. 2010/ , dicue everal additional embodiment of tent and aociated valve bodie, and can be referred to for further explanation and dicuion of addi tional feature and embodiment thereof. The entirety of thi copending application i alo exprely incorporated by ref erence herein With particular reference again to FIG. 1, in thi embodiment the valve body 30 i dipoed inide the tent 40. More pecifically, a kirt portion 96 of the valve body 30 i ewn to the firt eyelet 72 of the tent. A hemmed uptream end of the valve body 30 engage the firt eyelet 72 in the nonforehortening portion 50 of the tent 40. Valve leaflet are attached to the kirt portion and are configured to open and cloe during valve operation An elongate tubular portion 102 of flexible, longi tudinally expandable fabric i attached to a downtream end 104 of the kirt portion 96 in the illutrated embodiment. More particularly, a firt end of the fabric 102 i ewn to the downtream end 104 of the kirt portion about the circumfer ence of the kirt portion by a downtream eam, which alo connect to the econd eyelet 74 of the tent frame 40. Preferably, the fabric 102 i alo ewn to the forehortening cell 86 at everal point by connector titche In the illutrated embodiment, the fabric 102 curve around the econd end of the tent frame 40, generally fol lowing the curvature of the end anchor 90. A econd end of the fabric portion 102 i ewn to the anchor eyelet 92. Pref erably, the flexible fabric 102 i ufficiently expandable to move with the forehortening portion 60 a the tent 40 move between the compacted tate and the deployed, relaxed expanded State. A uch, in the illutrated embodiment, the tiue valve body 30 i confined to the nonforehortening portion 50 of the tent and the flexible fabric 102 pan the forehortening portion 60 of the tent. Thu, the tiue valve body 30 i not ubject to longitudinal expanion and contrac tion with the tent With reference next to FIG.3, a chematic repreen tation of the heart valve 28 a dicued above in connection with FIGS. 1 and 2 i depicted intalled in a human heart 110. The heart i hown in cro-ection, and repreent typical anatomy, including a left atrium 112 and left ventricle 114. The left ventricle 114 i defined by a mucular wall 116. The left atrium 112 and left ventricle 114 communicate with one another through a mitral annulu 120. Alo hown Schemati cally in FIG. 3 i a native anterior mitral leaflet 122 having chordae tendinae 124 that connect a downtream end of the anterior mitral leaflet 122 to the mucle wall 116 of the left ventricle 114. A left ventricle outflow tract 126 extend toward the top of the left ventricle A hown in FIG.3, the valve 28 of FIGS. 1 and 2 i dipoed o that the mitral annulu 120 i graped between the end anchor 90 and apical anchor 80 in accordance with a method of aligning and deployment of the tent 40 dicued previouly. A uch, all or mot of the tent 40 extend into the left atrium. The portion of the tent 40 dipoed uptream of the annulu 120 can be referred to a being poitioned upra annularly. The portion generally within the annulu 120 i referred to a poitioned intra-annularly. The portion down tream of the annulu i referred to a being poitioned Sub annularly. In the illutrated embodiment, only a part of the forehortening portion i poitioned intra-annularly or Sub annularly, and the ret of the tent 40 i Supra-annular.

31 US 2010/ A1 Nov. 25, In the illutrated embodiment, the anterior mitral leaflet 122 ha not been removed prior to deploying the replacement valve 28. Preferably, the poterior mitral leaflet (not hown) alo ha not been removed prior to deploying the replacement valve. However, in other embodiment, one or both of thee natural valve leaflet may be removed before deploying the replacement valve With reference next to FIG.4, another embodiment of a tent frame 140 i illutrated. The tent frame 140 i elongate and ha oppoing firt and econd end 142,144. A firt circumferential ring 164a compriing undulating trut i arranged adjacent the firt end 142. A econd circumferential ring 164b of undulating trut i dipoed adjacent the firt circumferential ring 164a. A circumferential forehortening ring 184 compried of interconnected generally diamond haped forehortening cell 186 i dipoed generally adja cent the econd end 144. A plurality of longitudinal trut 170 extend from the firt end 142 toward the econd end and terminate at a connection to correponding forehortening cell 186. Preferably, the longitudinal trut 170 pa through the undulating ring 164 and connect to apice of the ring 164. Preferably a locking member i formed on each longi tudinal trut 170 at the firt end 142. In the illutrated embodi ment the locking member comprie eyelet Anchor 190 extend from the forehortening cell 186 at the econd end 144 of the tent. In the illutrated embodiment, the anchor are bent o a to be directed gener ally toward the firt end 142 and generally radially outwardly The elongate portion of the tent 140 through which the longitudinal trut extend i a nonforehortening portion 150. The elongate portion of the tent made up of the fore hortening cell comprie a forehortening portion of the tent. An elongate portion of the tent between the undulating ring 164 and the forehortening ring 184 i referred to a a tranition portion In a manner a dicued above in connection with other embodiment, when the tent 140 i radially compacted, the length of the longitudinal ection will remain Subtan tially contant, but the length of the forehortening portion will increae. Correpondingly, when radially expanded from a compacted State to the expanded State a hown in FIG. 4. the length of the forehortening portion will decreae, while the length of the nonforehortening portion remain the ame The tent frame 140 i configured to upport a flex ible valve body having valve leaflet o a to provide a pro thetic heart valve implant. Preferably the valve body i di poed on the inide of the tent frame. Thi pecification preent multiple tent frame embodiment, which can Sup port Valve bodie of multiple hape and configuration o a to provide valve implant. For eae of illutration, thi peci fication and aociated drawing will refer to a tent or implant without necearily dicuing or howing the valve body. However, it i to be undertood that valve implant are to include a valve body having leaflet In the illutrated embodiment, each of the longitu dinal trut bend radially inwardly in the tranition portion 194between the econd ring 164b and the forehortening ring 184 o a to define a houlder 192 along which the outer diameter of the tent leen. A uch, and a hown in FIG. 4. the diameter of the tent at the firt end 142 i greater than the diameter of the tent 140 at the econd end 144 when the tent i in the relaxed poition. In the illutrated embodiment, the anchor 190 extend radially outwardly ufficient o that tip of the anchor are dipoed diametrically about the ame a or outwardly from the houlder In a preferred embodiment, the tent frame i ini tially provided a a circular cro-ection nitinol tube. The tube i laer cut according to a pattern correponding to the trut, cell and the like. The cut tube preferably i electro chemically polihed to a to remove rough edge. The cut and polihed nitinol tube may be haped in accordance with a deired manner, Such a haping the anchor to extend radi ally outwardly, and the nitinol tent frame may be heated treated to both etablih the hape memory and to obtain deired elaticity attribute With pecific reference to FIG. 5, a flat pattern for laer cutting a nitinol tube to form the tent 140 of FIG. 4 i hown. A indicated, the ring 164 are formed near a firt end of the flat pattern and the anchor 190 formed are at an oppoite econd end of the flat pattern. The ring 164 include the cut for the undulating trut, and the forehortening ring 184 include the cell 186 in a flat configuration. The trani tion area 194 i hown between the undulating ring 164 and the forehortening ring 184. Although the tent i initially cut to the pattern hown in FIG. 5, further haping and manipu lation i performed to form it into the hape hown in FIG. 4. For example, the tent a a whole i tretched radially, the anchor 190 are bent backwardly, and the longitudinal trut 170 in the tranition portion are deformed to form the houl der 192. The tent i then heat treated, a appropriate, o a to take on the illutrated deired hape a it relaxed hape In the embodiment illutrated in FIG. 4, there i no outwardly-extending anchor barb uptream from the anchor 190. Preferably, in practice, the tent 140 i placed o that the valve annulu i captured between the anchor 190 and the houlder 192. A uch, the houlder 192 and anchor 190 cooperate to hold the tent 140 in place, preventing the tent from being forced either way through the native annulu With reference next to FIG. 6, another embodiment of a tent 14.0a i hown, having tructure imilar to the tent 140. However, in the tranition portion 194 of tent 140a, the longitudinal trut 170 bend along their length to extend radially outwardly, and then bend again to extend radially inwardly o a to define an outward flare 196. In the illutrated embodiment, at leat portion of the undulating trut 65 of the econd undulating ring 164b take on the curvature of the at leat part of the flare In a manner imilar to the embodiment of FIG.4, the flare portion 196 of the tranition portion 194 effectually create a houlder 192. However, in the tent 14.0a embodi ment illutrated in FIG. 6, the diameter at the firt end 142 of the tent 14.0a i ubtantially the ame a the diameter of the tent at the econd end 144. Preferably, and in a manner having imilaritie to the dicuion above, during valve deployment, the native valve annulu will be captured in the area between the anchor 190 and the houlder 192. In a preferred embodiment, the flat cut pattern a illutrated in FIG. 5 can be formed into the hape of tent 140a. Thu, multiple tent hape can be formed from the ame cut pat tern With reference next to FIG. 7, yet another embodi ment of a tent 140b ha a tructure much like that of tent 140. However, a hown, an uptream anchor 190b extend from each of the free apice 118 of the econd ring 164. Preferably the uptream anchor 190b extend ditally pat the initial bend of the houlder 192. In thi embodiment, during

32 US 2010/ A1 Nov. 25, 2010 valve deployment, a native annulu preferably i captured between and engaged by the anchor 190, houlder 192 and uptream anchor 190b With reference next to FIG. 8, till another embodi ment of a tent 140c having baic tructure very imilar to tent 140 of FIG. 4 i illutrated. In the illutrated embodi ment, the longitudinal trut 170 bend in a tranition portion 194 o a to define a houlder 192. However, a hown in the illutrated embodiment, at or near the beginning of the inward radial bend, the longitudinal trut each plit into three arm 198a, 198b, 190c. Firt and econd arm 198a, b cooperate to define a cell which preferably extend the length of the houl der 192 from the point of bending to a forehortening cell 186 of the forehortening ring 184. A third arm 190c between the firt and econd arm 198a, b extend from the bend portion toward the econd end 144 of the tent 140c and radially outwardly o a to define a trut anchor 190c generally oppo ing the correponding downtream anchor 190. In a manner imilar to other embodiment dicued above, during valve placement, preferably a native valve annulu i captured in the pace between the downtream anchor 190 and the trut anchor 190c. The tent 140c i held ecurely in place by the oppoing anchor 190, 190c, and houlder In the embodiment dicued above, tent frame have been decribed in which uptream end of the tent ha a diameter greater than a downtream end of the tent, and embodiment have been decribed in which the uptream and downtream end have ubtantially the ame diameter. It i alo to be undertood that othertent embodiment may have a downtream end having a greater diameter than an aoci ated uptream end In the tent frame embodiment dicued above, the tent are cut from a tube having imilaritie to the embodiment hown in FIG. 5, and the anchor are formed during proceing by bending the anchor portion back wardly and radially outwardly. It hould be undertood that a plurality of anchor hape may be employed a deired. For example, with reference next to FIG.9A, one embodiment of an anchor 90a comprie a relatively large bae radiu having a generally U -haped bend. FIG.9B how an anchor 90b alo having a relatively large bae radiu but then continuing bending about the radiu beyond 180 o a to define a bulged feature before bending again o a to extend toward the firt end of the tent. FIG. 9C preent an anchor 90c having a relatively tight bae radiu leading to an outward bend and then another bend back inwardly o that the anchor tip i directed generally parallel to or lightly outwardly from a longitudinal axi of the tent. FIG. 9D illutrate an anchor 90d with a relatively large bae radiu leading to an outward bend before bending back inwardly o that the anchor tip i directed generally parallel to or lightly outwardly from a longitudinal axi of the tent. FIG.9E how an anchor 90e having a tight bae radiu that complete only about a turn, and then continue to curve lightly along it length having a very long bending radiu So a to approach, but not necearily complete, a 180 turn at it tip In the illutrated embodiment, the tip of the anchor have been hown a generally pointed or flat. It i to be undertood that numerou tip configuration can be employed a deired to optimize the engagement and attachment of the replacement heart valve to the native valve annulu. For example, FIG. 10a how an anchor tip 92a having a mooth radiu configured to limit trauma to the tiue. FIG. 10b illutrate an embodiment of an anchor tip 92b having an expanded ball radiu. Such a ball radiu can be created a a two-dimenional circular hape during the laer cutting pro ce, or can be a three-dimenional phere attached to the anchor tip during, for example, a ball welding procedure. FIG. 10c how a pointed anchor tip 92c configured to pro vide ome degree of penetration into the tiue of the valve annulu. FIG. 10d illutrate a flared anchor tip 90d config ured to ditribute anchor force over a urface area of tiue, but alo compriing a errated edge to penetratingly engage Such tiue. In additional embodiment a flared tip may have a mooth edge. Additionally, further tip configuration can be employed a deired to optimize engagement and fixation for different valve and different dieae morphologie. In fur ther embodiment, different tip configuration can be com bined within a ingle tent frame The embodiment a dicloed above in connection with replacement heart valve can be delivered to a patient heart valve annulu in variou way, uch a by open Surgery, minimally-invaive Surgery, and percutaneou, or trancath eter, delivery through the patient' vaculature. With refer ence next to FIGS. 11A and 11B, an embodiment of a delivery device 200 i hown in connection with a replacement heart valve. The illutrated embodiment comprie an elongate, teerable delivery catheter configured to be advanced through a patient' vaculature in a percutaneou delivery approach. The illutrated device 200 comprie an elongate inner tube 202 that i attached at it dital end to a noe cone 204. The inner tube 202 ha a lumen ized and configured to lidably accommodate a guidewire 206 o that the device 200 can be advanced over the guidewire 206 through the vaculature. A upport tube 208 concentrically encircle the inner tube 202 and i ized to be lidable over the inner tube. An outer heath 210 i dipoed o a to be lidable over the upport tube 208. In the illutrated embodiment, and preferably, in a manner a dicued in embodiment preented below, the upport tube 208 and outer heath 210 cooperate to grap onto an end of the replacement heart valve, which, for eae of illutration, i here repreented by howing only a tent frame. For delivery, the valve i compacted and held within the outer heath 210. (0073. With reference next to FIGS. 12 and 13, delivery device 220 configured in accordance of one embodiment i hown at variou tep along a equence or method of valve implant deployment. More pecifically, FIGS. 12A-12I dem ontrate chematic view of variou tep of a deployment proce, and FIGS. 13 A-13C how the tate of the delivery device 220 relative to a native heart valve annulu 120 at certain tage of deployment. In the embodiment illutrated in FIG. 13, the deployment device 220 deploy the heart valve implant 222 into a patient' native mitral annulu 120. It i to be undertood, however, that feature and apect a di cued herein may be employed when employing valve ele where in a patient' heart or other vaculature. (0074. With pecific reference to FIG. 13A, in ue prefer ably the delivery device 220 i advanced into the patient' heart 110 So that a dital end including a noe cone 224 pae through the dieaed native valve and through the native annulu 120. A uch, the delivery device 220 preferably i poitioned o that the anchor portion 226 of the valve implant 222, though till compacted within an outer heath 230, are dipoed generally on a ide of the native annulu oppoite an approach direction. Once the delivery device 220 i in place, and a next depicted in FIG. 12A, the outer heath 230 begin to be retracted thereby expoing the dital, or anchor end 232, of the valve implant 222. In the illutrated

33 US 2010/ A1 Nov. 25, 2010 embodiment, barb-haped anchor 226 are dipoed at the anchor end 232. It i to be undertood that other embodiment may employ other anchor tructure. A the outer heath 230 continue to be retracted a hown in FIG. 12B, more of the tent 222 i expoed and the anchor end of the tent begin to expand radially a progreively hown in FIGS. 12B, C and D. However, and a more particularly hown in FIG. 12D, a proximal end 234 of the tent frame 222 i till held ecurely within the outer heath 230, preferably by the outer heath cooperating with a Support tube o a to retrain the proximal end 234 of the tent 222 from being releaed from the delivery device 220. Neverthele, ince the dital portion 232 of the tent ha been Subtantially releaed it i free to expand and, in the embodiment hown in FIG. 12D, the dital end 232 of the tent can expand to it fully expanded tate while the proximal end of the tent remain retrained within the outer heath With additional reference now to FIG. 13B, when the dital end 232 i fully expanded a light back preure preferably i applied to the entire delivery device 220 o a to pull the tent 222 proximally and eat the implant 222 and particularly the anchor feature 226, againt the native annu lu. In the illutrated embodiment, the anchor feature 226 are eated againt the ubvalvular ide of the initial annulu 120. Proper eating of the implant can be confirmed via tactile feedback, external imaging, and/or other Suitable method With continued reference to FIGS. 12 and 13, if, for example, data indicate that the placement of the tent frame 222 hould be modified, uch a due to improper eating, alignment, engagement or the like. The implant 222 can be at leat partially reheathed and repoitioned. For example, with particular reference to FIGS. 12E and 12F, ince the implant ha not been fully deployed from the outer heath 230, the outer heath 230 can be moved ditally, thu engaging and compacting the tent frame o a to force it back into the outer heath. Such compaction will remove the implant 222 from it faulty poitioning. The implant can then be repoitioned and redeployed in a new poition by again moving the outer heath 230 proximally a depicted in FIG. 12G Once it i determined that the implant 222 i cor rectly eated, with the anchor 226 dipoed a deired in the Subvalvular ide of a native annulu, the implant can be com pletely releaed from the delivery device 220. Preferably, and with reference next to FIG.12H, uch complete releae come when the outer heath 230 continue to be retracted proxi mally, expoing the proximal end 230 of the tent frame 222 and diengaging the locking mechanim between the tent frame, Support tube and outer heath. A uch, the entire tent become free of any contraint by the delivery device and expand freely a depicted in FIGS. 12I and 13C o that the implant i fully deployed at the native annulu A hown in FIG. 13C, preferably a forehortening portion of the tent 222 i generally aligned with the native annulu 120 o that the annulu i captured between the anchor feature 226 and an oppoing anchor feature Such a a houlder portion of the tent. Of coure, in other embodi ment, other configuration of anchoring portion may or may not include a houlder, may include uptream and down tream anchor, and/or may include other tructure for engag ing one or both ide of an annulu. Once the implant i fully deployed, preferably the heath i again moved ditally to re-engage the noe cone, and the delivery device i removed from the patient In the embodiment dicued and illutrated in con nection with FIGS. 12 and 13, only a dital portion of the delivery device 220 i hown. It i to be undertood that uch a dital portion may be employed in multiple delivery device configuration. For example, a percutaneou, trancatheter approach delivery device uch a hown in FIGS. 11A and 11B can employ a dital portion imilar to that in the embodi ment hown in FIGS. 12 and 13. Alo, delivery device for u in minimally-invaive or even open Surgical procedure may have imilar tructure and imilar operation principle although Such device may advantageouly have ome differ ent mechanical propertie uch a increaed tiffne, than do embodiment ued in tran-catheter approache With reference next to FIGS. 14A-14L, an embodi ment of a delivery device 238 and a method and apparatu for loading a heart valve implant 128 onto the delivery device i hown. With reference firt to FIG. 14A, the loading appara tu comprie a compacting device 240 which, in the illu trated embodiment, i generally funnel-haped. The funnel 240 i elongate and comprie a firt and econd end 242,244. The firt end 242 ha a comparatively large diameter and the econd end 244 ha a comparatively mall diameter. A tran ition 246 progreively decreae the diameter between the firt and econd end. Preferably, an elongate compaction portion 250 i dipoed at and adjacent econd end 244. Preferably, the diameter within the compacted portion 250 i generally contant along it length and approache or matche the diameter of the econd end 244. I0081. A cap 252 i provided and i haped to fit through the firt or large end 242 of the funnel 240. Preferably an outer Surface of the cap 252 i configured to fit generally comple mentarily againt the inner urface of the funnel 240. A firt end 254 of the cap 252 i configured to fit generally onto and hook onto the firt end 242 of the funnel. A econd end 256 of the cap 252 i configured to fit within the funnel and prefer ably proximal of the compacting portion 250 of the funnel 240. The econd end of the cap preferably comprie a block ing tructure. I0082. With continued reference to FIG. 14A, an example heart valve 128 i hown. In the illutrated embodiment, the heart valve comprie the tent frame 140 decribed above in connection with FIG. 4. To aid in implicity of illutration, only the tent frame, and not the valve body, i hown. It i to be undertood, however, that in practice preferably a com pletely aembled heart valve implant i employed. Addition ally, it i to be undertood that implant and tent having configuration other than the pecifically hown implant can make ue of a compacting apparatu and delivery device having feature in accordance with the feature and principle dicued in connection with thi embodiment. However, thi tructure and method are particularly preferred in connection with implant having elf-expanding tent. I0083. A hown in FIG. 14A, preferably, the firt end 242 of the funnel 240 ha a diameter large enough to accommo date the fully expanded, at ret tent frame 140. Further, preferably, the tent frame i poitioned o that it firt end 142, at which the locking member 72 are dipoed, i facing toward the funnel. In the illutrated embodiment, the locking member comprie eyelet. Other tructure may be employed in other embodiment. I0084. A pull member 260 or "octopu' preferably com prie a pull ring 262 that i connected to a plurality of elongate arm 264. Each of the arm preferably terminate in a hook 266 or other ecuring member that i configured to

34 US 2010/ A1 Nov. 25, 2010 engage one of the locking member/eyelet 72. Preferably, there are the ame number of arm 264 a there are eyelet 72. Additionally, preferably the arm are ubtantially flexible o a to appropriately ditribute force and to obtain ecure purchae on the tent frame. In one embodiment, the arm 264 comprie a Suture material, although variou type of tring and even emi-rigid platic, wire or the like may be employed. I0085. With additional reference to FIG. 14B, an O-ring 270 i preferably dipoed about the compacting portion 250 of the funnel 240 and generally adjacent the econd end 244 of the funnel. In the illutrated embodiment, the O-ring 270 i an inwardly biaed broken ring hape having a pair of tab 272 adjacent the break in the ring. The tab ait in placing the ring over the compacting portion 250 of the funnel and other ide manipulating the O-ring. Preferably, the O-ring 270 i configured o that it at-ret poition i at a diameter Subtan tially le than the diameter of the compaction portion. I0086. With reference next to FIG. 14C, in operation pref erably the octopu arm 264 are threaded through the open econd end 244 of the funnel, out the firt end 242 of the funnel, and engaged with the implant 128 o that each octopu hook 266 connect to one of the eyelet 72, on the tent frame 140. The pull ring 262 i then pulled o a to pull the implant into and through the firt end of the funnel. A the pull ring continue to be pulled ditally, the tent engage the inner urface of the funnel at the tranition 246 and i forced to be radially compacted a the tent 140 i pulled through the funnel 240 until it i ubtantially compacted within the com paction portion 250 of the funnel and with the locking mem ber 72 of the tent frame extending out of the econd end of the funnel a hown in FIG. 14D With continued reference to FIG. 14D, once the implant ha been pulled into the compaction portion 250 of the funnel o that the locking member portion of the frame are expoed and extend out of the econd end of the funnel, the cap 252 preferably i inerted through the firt end of the funnel o that it econd end 256 i generally adjacent the econd end 144 of the tent frame. The blocking tructure at the econd end of the cap 252 preferably i configured to prevent the tent frame from moving backward out of the funnel. For example, the cap may have a thickne that Sub tantially block uchbackward movement. Other tructure uch a partial or full blocking of the funnel may alo be employed. With the cap in place, the octopu arm are dien gaged from the locking member a hown in FIG. 14E With reference next to FIG. 14F, additional tructure of the delivery device i illutrated in connection with the funnel 240 and implant 128 in the configuration of FIG. 15E. A hown, the delivery device 238 comprie an elongate inner tube 274 that i connected to a noe cone 276. Prefer ably, the inner tube 274 ha a lumen ized and adapted to accommodate a tandard guidewire 278 extending there through. The noe cone 276 preferably ha a generally atrau matic tip portion 280 at it dital end and ha a cavity 282 formed in it proximal end. A circumferential kirt 284 extend from the proximal end of the noe cone 276 and an inner urface 286 of the circumferential kirt 284 define the cavity An elongate upport tube 290 ha a lumen ized and configured to lidably accept and lide over the inner tube 274. A locking mechanim 292 compriing a plurality of locking feature 294 i dipoed adjacent a dital end of the upport tube 290. In the illutrated embodiment, the locking feature comprie boe 294 extending radially outwardly from an outer urface of the upport tube. The illutrated boe 294 are ized and haped to generally matingly fit the eyelet of the tent frame 140. (0090. An outer heath 300 i configured to fit lidably over the upport tube 290. The outer heath 300 ha a thickne defined between an outer urface 302 and an inner urface 304. A diameter of a lumen of the outer heath i defined by the inner urface 304 and preferably the lumen diameter 75 uch that the inner urface jut clear the locking boe 294 of the upport tube, a will be dicued and hown in more detail below. A raied portion 306 of the outer heath 300 i dipoed near but paced from a dital end of the outer heath, and a eat 308 i defined on the dital end of the raied portion 306. A will be dicued in more detail below, the raied portion and eat 308 are configured to engage a proximal end of the noe cone circumferential kirt Although the delivery device ha jut been intro duced in connection with FIG.14F, it i to be undertood that, in ome embodiment, the funnel i threaded over the delivery device o that the funnel concentrically urround the inner tube and i dipoed between the noe cone and the Support tube before the heart valve implant i loaded into the funnel. Thu, in ome embodiment, preferably the heart valve i loaded into and compacted within the funnel while the funnel i already dipoed over the inner tube of the delivery device With reference next to FIG. 14G, with the implant loaded into the compaction portion of the funnel, the Support tube 290 preferably i advanced ditally o that the eyelet 72 of the implant 140 are generally aligned with the boe 294 of the upport tube. However, in the illutrated embodiment, the diameter of the compaction portion 250 of the funnel i greater than the diameter of the upport tube 290, and thu the eyelet 72 are dipoed radially outwardly from the boe 294. With reference next to FIG. 14H, preferably the inwardly biaed O-ring 270 i lipped off of the end of the funnel and onto the expoed connecting portion of the tent frame o a to urge the eyelet inwardly and into engagement with the aligned boe. The implant i thu connected to the Support tube 220. (0093. With reference next to FIG. 14I, with the eyelet 72 and boe 294 engaged, the outer heath i then advanced ditally over the upport tube 290 o that the dital end of the outer heath extend over and ditally pat the boe. A dicued above, the lumen diameter of the outer heath i choen o that the inner urface 304 jut clear the boe 294 of the upport tube. Thu, when the outer heath i moved ditally pat the boe when the boe are engaged with the eyelet 72, the eyelet are captured between the outer heath 300 and upport tube 290, and the firt end of the tent i ecurely held by the upport tube. With the eyeletnow fully captured, the O-ring i removed With reference next to FIG. 14J, the outer heath 300 continue to be moved ditally relative to the upport tube 290 and attached implant 140. In the illutrated embodiment, the outer heath inner diameter i le than the diameter of the funnel compaction portion. Thu, a the outer heath i moved ditally, it progreively radially compact the heart Valve implant. A the implant i progreively compacted within the outer heath, the funnel 240 preferably i alo moved ditally o that the implant i progreively tranferred from being contained within the funnel to being contained within the outer heath 300. Eventually, the funnel i completely

35 US 2010/ A1 Nov. 25, 2010 removed from the implant and the outer heath contain the implant from it firt to it econd end, a hown in FIG. 14.K In the embodiment illutrated in FIG. 14K, the tent frame 140 of the implant ha anchor 190 extending radially outward at the econd end 144. Thoe anchor are not cap tured within the outer heath in thi embodiment, although the outer heath preferably capture ubtantially the ret of the tent frame therewithin With the implant captured in the outer heath, the funnel preferably can be removed from the delivery device. In the illutrated embodiment, the mallet diameter portion of the funnel i greater than the outer diameter of the noe cone. Thu, the funnel can be removed by moving it ditally over the noe cone. In other embodiment, the funnel may have a leer diameter than the noe cone, and can be moved by other mean uch a by cutting the funnel. In till other embodi ment, the funnel can have a multiple piece and/or hinged contruction and may be held cloed by a releaable clamp, clip, or the like. A uch, once it ha erved it purpoe and the implant i tranferred to the outer heath, the funnel can be diaembled and/or opened and removed without necear ily drawing the funnel over the noe cone With reference next to FIGS. 14K and 14L, with the funnel removed and the implant ubtantially captured within the outer heath 300, the noe cone 276 i pulled proximally until a hown in FIG. 14L, the kirt portion 284 of the noe cone engage and compact the anchor 190, and eventually the proximal end of the noe cone kirt engage the eat 308 defined on the raied portion of the outer heath. The anchor 190 are thu ecured between the noe cone kirt inner urface 286 and the outer heath outer urface 302. The implant i thu fully contained within the delivery device 238 which preferably maintain a Subtantially contiguou outer Surface. The implant may be delivered to a native heart valve annulu in a manner having imilaritie to the embodiment dicued above in connection with the FIGS. 12 and In the embodiment dicued above in connection with FIGS. 14, the noe cone 276 i depicted a rigidly attached to the inner tube 274. In another embodiment, the noe cone may be electively detachable from the inner tube o that the valve implant can be independently drawn into a funnel compaction apparatu, without the funnel being mounted over the delivery device. Thu, a loaded funnel a depicted in FIG. 14E can be advanced over an inner tube, and then the noe cone may be attached to the inner tube. In uch an embodiment, the funnel may have a maller diameter than a hown and dicued above, a the funnel i not necearily of large enough diameter to be drawn over the noe cone, and intead the noe cone may be removed in order to remove the funnel. In fact, in Such an embodiment and in Some option of Such an embodiment, the noe cone i not attached to the inner tube until after the funnel i removed and the implant i ubtantially captured within the outer heath With reference next to FIGS. 15A-H further embodiment of a device for loading a heart valve implant 128 onto a delivery device 238 are hown. For eae of illu tration, the ame implant 128/tent frame 140 ued in con nection with the embodiment decribed in FIG. 14 i employed, a well a other imilar tructure, uch a the pull member 260, and delivery device 238 tructure uch a the inner tube 274, noe cone 278, upport tube 290 and outer heath With particular reference to FIG. 15A, the illu trated embodiment comprie a two-piece compaction device 310 compriing a funnel portion 315 and a loading tube portion 320. Preferably, the funnel portion 315 and the load ing tube portion are detachably connected to one another. Further, preferably the loading tube portion 320 i elongate and ha a Subtantially contant diameter. A with other embodiment, preferably the octopu arm 264 of the pull member 260 extend through the compaction device 310 to hook onto and engage portion of the implant 128, 140. In the illutrated embodiment, the hook 266 engage the tent 140 at the econd end 144 of the tent In practice, the pull ring 262 i pulled o a to pull the tent into the compaction device and through the funnel portion 315 to radially compact the tent 140. Preferably, however, a loading inner tube 328 i arranged concentrically within the tent 140 a it i being compacted. A hown in FIG. 15B, the implant 128, 140 eventually i radially com pacted within the loading tube 320 and concentrically ur rounding the loading inner tube 328. A hown in FIG. 15B, preferably the loading tube 320 ha a length that i omewhat le than the total length of the tent 140 when the tent i in it compacted arrangement. A uch, at leat the eyelet 72 of the firt end 142 extend beyond an end of the loading tube 32O With reference next to FIG. 15C, once the implant 128 i compacted within the loading tube 320, the pull mem ber 260 may be detached from the implant and the loading tube may be detached from the funnel portion 315 o that the loading tube end aociated compacted Stent 140 and inner loading tube 328 can be independently moved and manipu lated. (0103 FIG. 15C how an embodiment in which the deliv ery device 238 i configured o that the noe cone 276 can be releaably detached from the inner tube 274. Preferably, the inner loading tube 328 define an inner lumen having a diam eter greater than the outer diameter of the inner tube 274 o that the inner loading tube can be threaded over the inner tube o a to place the compacted implant 128, 140 on the delivery device 238 between the noe cone 276 and the upport tube 290. In another embodiment, the noe cone i not detachable from the inner tube. Thu, in order to get the compacted implant dipoed on the delivery device 238, the implant i threaded onto the inner tube 274 before the upport tube 290 and outer heath 300 are threaded over the inner tube In either cae, however, once the upport tube 320 with it accompanying compacted implant are threaded over the inner tube 274 a deired, the inner loading tube prefer ably i removed from within the compacted implant and removed from the delivery device. For example, in the embodiment illutrated in FIG. 15C, the loading inner tube 328 can be removed ditally off the end of the inner tube 274 when the noe cone 276 i detached. In other embodiment, the loading inner tube 328 can be lid off of the inner tube 274 before the upport tube 290 and outer heath 300 are advanced over the inner tube 274. A uch, and a hown in FIG. 15B, the loading tube 320 with it attendant compacted implant 128, 140 i dipoed on the inner tube 274 between the noe cone 276 and the upport tube With reference next to FIGS. 15E-15H, preferably the delivery device 238 i then manipulated and operated in a manner imilar to that a dicued above in connection with FIGS. 14G-K o a to capture the firt end 142, and more pecifically the eyelet 72, of the tent frame 140 within the outer heath 300 uing a method of apparatu including the

36 US 2010/ A1 Nov. 25, 2010 upport tube 290 and boe 294, although other configura tion of locking mechanim 292 may be employed a deired With pecific reference next to FIG. 15G, in one embodiment, after the implant ha been captured within the outer heath 300, the loading tube portion 320 preferably i removed from around the delivery device 238. In the embodi ment illutrated in FIG. 15G, the loading tube 320 can be moved proximally over the outer heath 300 a the outer heath engage the noe cone 276. In the embodiment illu trated in FIG. 15H, the loading tube 320 i advanced ditally o a to be removed over the noe cone 276 a the outer heath alo i ditally to engage the noe cone In the illutrated embodiment, the loading tube 320 ha a lumen diameter Sufficiently large o that it can be removed over the noe cone 276, or at leat clear the raied portion 306 of the outer heath 300. In other embodiment, however, the loading tube may have a lumen diameter more cloely approaching the inner diameter of the outer heath lumen. Removal of the loading tube 320 after the implant i heathed within the outer heath 300 may involve breaking or cutting the loading tube 320 or, in other embodiment, the loading tube comprie multiple piece that can be dia embled or opened o a to remove the tube from the delivery device In one of the embodiment dicued above, the noe cone i detachable from the inner tube. It hould be undertood that, in one uch embodiment, the noe cone i not reattached to the inner tube until after the compacted tent i at leat partially pulled into the outer heath, and the loading tube i removed from the delivery device 238. A uch, in thi embodiment, the loading tube can have alumen diameter le than an outer diameter of other tructure of the delivery device In the embodiment dicued above, an inwardly biaed O-ring 270 i employed to urge locking member 72 of the tent into engagement with locking boe 294 of the upport tube 290. It i to be undertood, however, that other method and tructure can be employed to engage the lock ing member of the tent with the upport tube. For example, a uer can manually urge the locking member into engage ment with the boe. Additionally, other tructure, uch a a belt, pecially-configured clamping plier, or the like can be employed to urge the locking member into engagement with one another. It i contemplated that yet further tructure can be employed for thi purpoe With reference next to FIGS. 16A and 16B, another embodiment of a multi-piece compaction device 410 com prie a funnel portion 415 and an elongate load tube 420 that are detachably connected to one another. The funnel portion and load tube preferably hare at leat ome feature with other embodiment dicued in thi pecification. In the illutrated embodiment, the maller end of the funnel portion comprie an L-lock track 417 formed therein. The load tube 420 comprie an overlap portion 422 having a lock member 424. A diameter of the overlap portion 422 i reduced o that the overlap portion will fit within the end of the funnel portion 415 at the L-lock track 417. The lock member 424 i lidable within the track 417 o a to detachably ecure the funnel portion 415 and load tube 420 together. It i to be undertood that other tructure can be employed to detachably connect the funnel and load tube With reference next to FIGS. 17A-G, in another embodiment, an implant 400 i provided in which longitudi nal trut 406 terminate in locking member 404 at a non anchoring end of the tent 400. The illutrated locking mem ber 404 have a generally arrowhead-type hape that i enlarged relative to the adjacent trut 406. Preferably a pull member 260a engage the tent 400 and pull it through the compaction device 410 o that the implant 400 i compacted within the load tube 420. The load tube and implant can then be removed from the pull member 260a and funnel portion 415 and loaded onto an inner tube 274a of a delivery device With particular reference to FIG. 17B, the delivery device preferably include the inner tube 274a, which i attached to a noe cone 276a. A upport tube 430 i lidably dipoed over the inner tube, and an outer heath 300a i lidably dipoed over the inner tube. Preferably an inner lumen diameter of the outer heath 300a i greater than, but very cloe to, an outer diameter of the upport tube 430. A locking mechanim 432 i provided at the dital end of the upport tube 430. The locking mechanim 432 preferably comprie a tapered urface 434 that lead to a circumferen tial capture lot 440. A plurality of guide lot 444 are pro vided and configured to generally align with trut 406 of the implant 400. Preferably, the load tube 420 i ized uch that the radially compacted implant 400 ha an outer diameter le than an outer diameter of a proximal ridge of the tapered urface 434 immediately adjacent the capture lot To load the compacted implant 400, the upport tube 430 i advanced o that the tapered Surface 434 engage and deflect the locking member 404 and aociated trut 406 of the implant 400, a hown in FIG. 17C. The upport tube 430 continue to be advanced until the deflectedlocking member 404 clear the proximal edge of the tapered urface 434, at which point the locking member 404 are no longer deflected, and will pring into the capture lot 440, preferably with an audible click. When properly aligned, the trut 406 corre pondingly pring into the guide lot 444 a depicted in FIG. 17D, and the tent 400 and upport tube 430 are now engaged With reference next to FIG. 17E, the outer heath 300a i next advanced ditally o a to cover the capture lot 440 and thu ecurely capture the locking member 404 within the heath 300a. A the heath 300a continue to be advance ditally, the compacted implant i tranferred from the load tube 420 to the heath3.00a. Preferably a ditalend of the heath engage an end of the load tube 420 during Such advancement, and thu anchor member that may in ome embodiment be biaed radially outwardly can be effectively tranferred from within the load tube 420 to within the heath With additional reference to FIG. 17F preferably the noe cone 276a i ized o that the load tube 420 can be lid thereover and removed from the delivery device. In the illutrated embodiment the dital end of the heath 300a at leat partially overlap the noe cone, and the heath i haped to provide a mooth tranition from the dital end of the heath to the noe cone. Of coure, other embodiment may employ other tructural interaction between the outer heath and the noe cone, which may in ome embodiment be removable In practice, the illutrated delivery device ha opera tional feature that may be imilar to other embodiment dicued herein. For example, the implant can be partially deployed, but reheathed for repoitioning. If neceary, the implant can alo be reheathed for removal from the patient. In ome Such embodiment, in the event of complete reheathing, radially-outwardly-biaed anchor member may

37 US 2010/ A1 Nov. 25, 2010 not be able to be completely recaptured within the outer heath 300a in the ame poition a originally provided. How ever, continued advancement of the heath 300a after engage ment of the anchor can have the effect of bending the anchor backwardly (ditally) o that it i effectively captured between the heath and noe cone. The delivery device can then be further manipulated, and even removed from the patient, with the entire implant, including anchor portion, fully reheathed Although thi invention ha been dicloed in the context of certain preferred embodiment and example, it will be undertood by thoe killed in the art that the preent invention extend beyond the pecifically dicloed embodi ment to other alternative embodiment and/or ue of the invention and obviou modification and equivalent thereof. In addition, while a number of variation of the invention have been hown and decribed in detail, other modification, which are within the cope of thi invention, will be readily apparent to thoe of kill in the art baed upon thi dicloure. In fact, the embodiment pecifically dicloed herein have been ued a a vehicle to decribe certain inventive feature that can be employed alone or in variou combination in multiple additional embodiment. Thu, it i contemplated that variou combination or Subcombination of the pecific feature and apect of the embodiment may be made and till fall within the cope of the invention. For example, Sup port tube embodiment uch a in FIG. 14 can be modified to capture locking member within a capture lot a dicloed in FIG. 17, and vice vera. Further, even though the tent decribed herein have been configured to forehorten, certain feature uch a the method and apparatu for controlled delivery a dicued in connection with FIGS. 12 and 13, can be employed with elf-expanding tent that don t necearily forehorten, and don t necearily have anchoring feature comparable to the embodiment dicloed herein. Further, the delivery device depicted in FIGS. 12 and 13 can be replaced with delivery device employing principle a dicued in FIGS. 14, 15, 17 or the like. Accordingly, it hould be under tood that variou feature and apect of the dicloed embodiment can be combined with or ubtituted for one another in order to form varying mode of the dicloed invention. Thu, it i intended that the cope of the preent invention herein dicloed hould not be limited by the par ticular dicloed embodiment decribed above, but hould be determined only by a fair reading of the claim that follow. What i claimed i: 1. A method of loading a device for delivering a elf expanding vacular implant, compriing: drawing a relaxed, expanded vacular implant through an elongate form having a decreaing diameter to a load tube portion having a compacted diameter, engaging a locking end of the implant with a locking mechanim dipoed on a Support tube: advancing an outer heath over the engaged locking end and Support tube o a to capture the locking end between the heath and upport tube; and advancing the outer heath over the compacted implant So a to tranfer the implant from within the load tube to within the outer heath. 2. A method a in claim 1, whereintranferring the implant from within the load tube to within the outer heath comprie further compacting the implant. 3. A vacular implant delivery device, compriing: an elongate Support tube having a dital end, a locking mechanim being dipoed at or adjacent the dital end; an elongate heath adapted to lide over the Support tube; and a elf-expanding vacular implant having a locking mem ber; wherein the Support tube locking mechanim i configured to engage the implant locking member o a to block axial movement of the implant when the locking mecha nim and locking member are engaged; and wherein the heath ha an inner lumen ized to block the implant locking member from moving radially relative to the Support tube locking mechanim Sufficient to releae from the Support tube locking mechanim. 4. A vacular implant delivery device a in claim3, wherein the elf-expanding vacular implant remain connected to the Support tube o long a the heath extend ditally pat the Support tube locking mechanim, and wherein the device i configured o that when the heath i moved proximally pat the Support tube locking mechanim, the implant locking member move radially out of engagement with the Support tube. 5. A method of delivering a elf-expanding vacular implant, compriing: advancing the implant within a patient' vaculature to a deired delivery location, the implant being advanced while maintained in a compacted configuration within a heath, a firt end of the implant being captured between the heath and a Support tube locking mechanim; withdrawing the heath proximally ufficient to enable a econd end of the elf-expanding implant to expand radially to a fully expanded ize while the firt end of the implant remain captured; poitioning the econd end of the implant in a deired poition and orientation while the firt end of the implant remain captured; and withdrawing the heath proximally ufficient to releae the firt end of the implant. 6. A method a in claim 5, wherein if it i determined that the econd end of the implant i not poitioned a deired, the method additionally comprie moving the heat ditally o a to at leat partially recapture the implant within the heath, repoitioning the delivery device, and again withdrawing the heath proximally ufficient to enable the econd end of the implant to expand radially. c c c c c