‘US 201802 us) United States 2) Patent Application Publication co) Pub. No.: US 2018/0271651 Al oy oy ~ 0), ey (3) () CHRI JANSON et al. FRAME FEATURES FOR PROSTHETIC MITRAL VALVE: Applicant: 4 St, Paul, MN « Inventors: Mark CHRISTIANSON, Plymouth MN (US); Michael EVANS, ‘Minneapolis, MN (US): Robert M. VIDLUND, Forest Lake, MN (US) Assignee: Tendyne Holdings, Inc. St. Paul, MN ws) Appl. No 18991,586 Filed: May 29, 2018 Related U.S. Application Data Continuation of application No, PCT/US2016) (964610, filed on Dee. 2, 2016, Provisional application No, 62/262,511, filed on Dec 3.2015 1OSIAL (43) Pub. Date: Sep. 27, 2018 Publication Classification (1) Inte AGIF 324 (2006.01) (2) USC cic AGLF 22418 (2013.01); ABIE 2/246 (@O13.01}; 46IF 2230/008 (2013.01); 461 225110069 (2013.01); A6IF 2/2409 2013.01) AG1F 22300078 (201301); A6IF 22500037 (01301) on ABSTRACT Prosthetic hear valves are deseribe herein that can provide clearance to the left ventricle outlow tract (VOT), reduce the possibility of undesirable outflow gredients, andor limit for prevent LVOT obstructions when implanted in the hear. Tn some embodiments, « prosthetic heart valve ean include fn outer frame having a cull portion that is disposed at an angle (cg. 80 degrees) relative tothe vertical axis ofa body portion oF the otter frame, so thatthe prosthetic valve ea Seat securely in the annulis while not obstracting the Ventricular outflow tract oF the hear. In some emboslmmets 8 prosthetic heart valve can alternatively, oF additionally, include subvalvular components having a short profile, such thatthe prosthetic valve can seat securely in the annulus while not obstructing the ventricular outflow tract of the hear.Patent Application Publication Sep. 27, 2018 Sheet 1 of 34 US 2018/0271651 Al 100 FIG. 1A 110 180 185 140 FIG. 1BPatent Application Publication Sep. 27, 2018 Sheet 2 of 34 US 2018/0271651 Al 140 154 152 150 160 170 154 154 152 152 152 4 154 isa 152 152 FIG. 2B FIG. 2CPatent Application Publication Sep. 27,2018 Sheet 3 of 34 US 2018/0271651 ALPatent Application Publication Sep. 27, 2018 Sheet 5 of 34 US 2018/0271651 ALPatent Application Publication Sep. 27, 2018 Sheet 6 of 34 US 2018/0271651 AL 532 FIG. 7 “\Patent Application Publication Sep. 27,2018 Sheet 7 of 34 US 2018/0271651 AL 590 FIG. 8 500Patent Application Publication Sep. 27, 2018 Sheet 8 of 34 US 2018/0271651 AL FIG. 9‘US 2018/0271651 AL Sep. 27, 2018 Sheet 9 of 34 Patent Application Publication 000000000> == ———— 00000000 Oe — eee _— ©00O0000 \Q ICS OT “Old a versPatent Application Publication Sep. 27, 2018 Sheet 10 of 34 US 2018/0271651 Al \ XC> \ \eseeiens g 8 CH5SS TEES =0FIG. 14 FIG. 15Patent Application Publication Sep. 27, 2018 Sheet 13 of 34 US 2018/0271651 Al FIG. 16Patent Application Publication Sep. 27, 2018 Sheet 14 of 34 US 2018/0271651 Al FIG. 17Patent Application Publication Sep. 27, 2018 Sheet 16 of 34 US 2018/0271651 Al 536b ———_ 32x42 FIG. 19 — \ 536aPatent Application Publication Sep. 27, 2018 Sheet 17 of 34 US 2018/0271651 Al 575 FIG. 20 560 :Patent Application Publication Sep. 27, 2018 Sheet 18 of 34 US 2018/0271651 Al 600 ad ee eens —— 616 — ou 655) +— 612 FIG. 21 600 610 655) 640 FIG. 22Patent Application Publication Sep. 27, 2018 Sheet 19 of 34 US 2018/0271651 AL FIG. 23‘US 2018/0271651 AL Sep. 27, 2018 Sheet 20 of 34 Patent Application Publication s@ ‘Old ve ‘OldPatent Application Publication Sep. 27, 2018 Sheet 21 of 34 US 2018/0271651 Al FIG. 26Patent Application Publication Sep. 27, 2018 Sheet 22 of 34 US 2018/0271651 Al <— 816 826 +— 814 | 0 Nn 9 a a FE a 4 ie g & g g nN NC 9 au 3 alPatent Application Publication Sep. 27, 2018 Sheet 23 of 34 US 2018/0271651 Al FIG. 29B FIG. 29APatent Application Publication Sep. 27, 2018 Sheet 24 of 34 US 2018/0271651 Al 90° So 4 \ IN \ 180°, Loe : $2 : \ / ~— FIG. 29€ 270° 90° a > 7 agop_ Lo _—* _ FIG. 29DPatent Application Publication Sep. 27, 2018 Sheet 25 of 34 US 2018/0271651 Al 972 FIG. 30BUS 2018/0271651 AI Patent Application Publication Sep. 27,2018 Sheet 26 of 34 90€ “Old 026 006Patent Application Publication Sep. 27, 2018 Sheet 27 of 34 US 2018/0271651 Al FIG. 31A 1074 1900 1020Patent Application Publication Sep. 27, 2018 Sheet 28 of 34 US 2018/0271651 Al 1020 La FIG. 31B 1000 1056 1055 u2 FIG. 31Catent Application Publication Sep. 27, 2018 Sheet 29 of 34 US 2018/0271651 Al FIG. 32A a / { 2Sep. 27, 2018 Sheet 30 of 34 US 2018/0271651 Al Publication Patent Application 9 IZE “Old ~ aZ€ “OldPatent Application Publication Sep. 27, 2018 Sheet 31 of 34 US 2018/0271651 Al | a 1254-1 FIG. 33APatent Application Publication Sep. 27, 2018 Sheet 32 of 34 US 2018/0271651 Al FIG. 33B + a aPatent Application Publication Sep. 27, 2018 Sheet 33 of 34 US 2018/0271651 Al FIG. 34BPatent Application Publication Sep. 27, 2018 Sheet 34 of 34 US 2018/0271651 AL ase ‘Old VSE Old LIN, LOAT F my \ (| AyUS 2018/0271651 Al FRAME FEATURES FOR PROSTHETIC ‘MITRAL VALVES CROSS-REFERENCE TO RELATED 'APPLICATIONS| 10001) This application is a continuation of Intemational PCT Application No, PCT/US2016064610, entiled “Frame Peatures for Prosthetic Mitral Valves", fled Dec. 2, 2016, ‘which claims priority to and the benefit of US, Provisional Patent Application No. 62/262,S11, filed Dee. 3, 2015, ‘entitled “Frame Features for Prosthetic Mitral Valves,” each ‘of the disclosures of which is incorporated herein by seler- BACKGROUND 10002] Prosthetic heset valves, including those for inser tion inte atrioventeicular valves (eicuspid and mitral valves) ‘are susceptible to various problems, including problems ‘with ventricular outflow tract abstraction, Some known prosthetic mitral valves, for example, apply undesirable orees to the anterior segment of the native valve thereby contributing 19 undesirable interuption of blood flow into the aorta, which anatomically sits immediately behind the erioe sepment of the miteal mavlus, As aother example, some known prosthetic mitral valves include subvalvular ‘components that obstret the left ventriculae outlow tact (LVOT) andlor dieect blood flow from the atrium to the ventriefe ina manner that ereates undesirable flow gradients and LVOT interuption, Accordingly, there is till a necd for ‘a prosthetic heart valve that can adress some or all ofthese problems, SUMMARY, 10003] Prosthetic heart valves are describod herein that ‘can provide clearance tothe LVOT, reduce the possibility of undesirable outflow gradients, andor limit or prevent LVOT ‘obstructions whea implanted inthe heat. ln some embod mens, @ prosthetic heart valve ean inelude an outer frame assembly including an outer frame having a eu portion ‘configured to be disposed atleast ptally within an atrium, ‘ofa heart and a body portion configured to be disposed ia a ventricle of the hear, The body portion has a posterior side tnd an opposite anterior side and the anterior side can have ‘maximum eight lager than a maximum height of the posterior side such that when the prosthetic heart valve is ‘disposed within a native annus ofthe heart, an anteriorend ‘ofthe outer frame is disposed al an acute ange relative t a centerline of the outer frame, An inner valve assembly is ‘disposed within and coupled to the outer frame assembly and includes an inner frame having an atrium end and 3 ventricle end and having centerline substantially parallel t© the centerline ofthe outer frame. The inner valve assembly includes valve leallet assembly supported! on the inner fame. BRIEF DESCRIPTION OF THE DRAWINGS 10004} FIGS, 14 and 1B are schematic perspective and side cross sectional views ofa prosthetic heart valve aceord- ing to an embodiment. [0005] FIGS. 24-C are schematic views ofan inner valve assembly ofthe prosthetic heart valve of FIGS. 14 and 1B, [0006] FIG. 3'is top view of a prosthetic heart valve ‘acconting (0 another embodiment. Sep. 27, 2018 [0007] FIG. 4 is a top view of a prosthetic heart valve cording to anther embodiment [0008] FIG. 8 is «perspective side view ofa portion of a Proshitic hau vuve seordng to anther enbodimeal [0009] FIG. 6 is an exploded view of a prosthetic heart Valve stem aconding another bodies [0010] FIGS. 7-9 are front, bottom, and top views of a Prsthetie het valve according to another embodiment [0011] FIG. 10/is an opened and flattened view of the inner Irameof the valve of FS. 79. nan amexpande coat {W012} FIGS. 11 and 12 arse and botom views, respec: tively, of the inner fame of FIG. 10 in an expands coufipration, [0013] FIG. 13s an opened and flattened view of the outer Frame ofthe valve of FIGS. 7-9, in an anexpandedconfig- [0014] FIGS. 14 and 15 are side and top views, respec- tively, of the ovter frame of FIG. 13 nan expanded coafipration [W013] FIGS. 16-18 ar sida, rom, and top views of an assombly ofthe ner frame of FIGS. 10-12 snd the outer frame of HGS. 1848. [0016] FIG. 19 is a plan view of a fabric pattern for the Inner and onter coverings af the utr fame sembly ofthe Yalve of TGS. 79. [W017] FIG. 20 is plan view ofa fabric patter for the feats and wre covering the nmr valve ase of ths talve of FIGS. 739. [0018] FIGS. 21 and 22 are schematic perspective and side Gross etional views ofa prosthetic hear valve according Sher embodiment [W019] FIGS. 23-28 are op and perspective views of « prosthetic heart vive according to anther embodiment [0020] FIG. 26 is an exploded view of a prosthetic heart Yalve system according to another enbodinent [Wai] FIGS. 27 and 28orschematic perspective and side Cross sectional views ofa prosheicheat valveqsooring 1 ther embodiment [0022] FIGS. 294-D are schematic illustrations of stiff- tess profiles of a prosthetic heat valve according to another embodiment [W029] FIG, 308 isa side view of an onter fame of a prosthetic hee valve having a ante eu arrangement, $ deployed or biased eonfgeration,scconing oan embod- ine [0024] FIG. 308 is a schematic cross-sectional side view othe prosthte art valve sown in FIG. 30, inloing tn ier valve asebly. [0025] FIG. 30C is a side view of the prosthetic heart Valve shown in FIG. 30A, having an angled cu arange- ‘neat and in deployed or based contin, and side view of a posthe heart valve without an angled olf Jmangement in deployed or Bisse configration. [0026] FIG. 31A is a side view of an outer frame of a prosthetic heart valve having a shor. ody portion, in xployat or based configation, according tan emiboi- seat. [0027] FIGS. 31B and 31C illustrate schematic cross- Seetonal perspective and side views, respectively, of the prosthetic hear valveshown in FIG. 1A, ashing an inner Salve assem: [0028] T1GS.324.32C are top viows ofa prosthetic heart Yalve having an inner valve assenbly radily oft (FIGSUS 2018/0271651 Al 32A and 32C) and radially centered (FIG. 328), in a “deployed or biased configuration, according to an embodi- ment, [0029] FIG. 334 is a top view a prosthetic heart valve having an inner valve assembly rotated relative 10 an. A2 segment of an outer fame, in a deployed or biased contigu- ration, according to an embodiment. [0030] FIG. 338 is bottom view of the inner frame ofthe prosthetic valve of FIG. 33, [0031] FIGS. 34 and 340 illustrate inside view an inner Jame of a prosthetic hear valve in a compressed and an uncompressed amingement, respectfully. ia a deployed oF biased configuration, according to an embodiment. [0032] FIGS. 384’ and 38B illustrate in pari eross- sectional side view and top view, respectfully, an exemplary prosthetic heart mitral valve in a deployed or biased con: ‘iguration and seated in a native mitral valve annulus of & hear. DETAILED DESCRIPTION 10033] Prosthetic heart valves are described herein that ‘can provide clearance ta the LVOT, reduce the possibilty of undesirable outflow gradients, andor limit or prevent LVOT ‘obsiructions whea implanted inthe heart. In some embodi- ments, @ prosthetic heart valve can inelude an otter frame having a cull portion that is disposed at an angle (e280 degrees) relative tothe vertical axis of a body portion ofthe ‘ute ae, so thatthe prosthetic valve ean seat securely i the annulas while not obstucting the ventricular ottllow tract ofthe heart. prosthetic heart valve can alternatively, cr additionally, include subvalvular components having 3 short profile, so that the prosthetic valve can seat securely in the annulas while not obstnicting the ventricular outflow teact of the heat, 10034) A schematic representation of a prosthetic heart valve 100 is showa in FIGS. LA aad 1B. Prosthetic heart valve 100 js designed to replace a damaged or diseased native heart valve such as a mitral valve. Valve 100 includes ‘an outer frame assembly 110 and an inner valve assembly 140 coupled to the outer frame assembly. 0035) "Although not separately shown in the schematic ‘ustation of outer frame assembly 110 in FIGS. 1A and 1B, ‘outer Fame assembly 110 may be formed of an outer frame 120, covered on all ora portion ofits outer face with an outer ‘covering 130, and covered on al ora portion of ts inner face by an inner covering 132, 10036] Outer frame 120 can provide several functions for prosthetic heart valve 100, including serving asthe primary Structure, aS anchoring. mechanism andor an attachment Point for a separate anchoring mechanism to anchor the valve to the native heart valve apparatus, a suppor to carry jnmer valve assembly 140, and/or «seal to inhibit paraval- vilar leakage between prosthetic hea. valve 100 and the native heart valve apparatus 10037] Outer frame 120 is preferably formed so that it ean be deformed (compressed and/or expanded) and, whe: released, retum to its original (undeformed) shape. To achieve this, outer ame 120 is preferably formed of mate~ rials, such as motals or plastics, that have shape memory properties. With regards to metals, Nitinol® has been found to be especially useful since it can be processed t0 be ‘austenitic, martensitic or super elastic. Other shape memory alloys, such as Cu—Zn—Al--Ni alloys, and Ca—Al-Ni alloys, may be used Sep. 27, 2018 [0038] Outer frame 120 is preferably formes from a laser cut, thinwalled tube of Nitinol. The laser cuts form regular cutouts in the thin Nitinol® tube. The tube ean be expanded radially, placed on @ mold oF mandrel of the ‘desired shape, heated to the martensitic temperature, and ‘quenched. The teatment of the frame in this manner will orm an open latce frame structure, and may have a area tend or eat the atrium end portion 126 of otter frame 120. (Ovter frame 120 thus has shape memory properties and will readily revert to the memory shape at the calibrated tem- perature. Altematively, outer frame 120 may’ be constructed {om bruided wire or other suitable material [0039] Inner valve assembly 140 is shown schematically fn more detail in PIGS. 2A-2C. Inner valve assembly 140 can include an inner frame 150, aa outer covering 160, and Jeaflets 170. In the simplified form shown schematically in FIG. 2A, inner fame 180 includes six axial posts or frame ‘members that suppor outer covering 160 and leaets 170. Leaflets 170 are attached along three ofthe poss, shown as commissiate posts 152 in FIG. 2, and outer covering 160 is attached to the other three posts, 154 in FIG. 2A, and ‘optionally to commissure posts 152. ln the simplified form illustrated schematically in FIG. 2, each of outer covering 160 ad leaflets 170 are formed of approximately rectangi- Jar sheets of material, which are joined together at their upper, or lsium end. The lower. ventricle end of outer covering 160 may be joined to inner covering 132 of outer frame assembly 110 (901 shown in FIG. 2A), and the lower, ventricle end of leaflets 170 may form fee edges, though teaupled to the lower ends of commissure posts 152. [040] As shown in FIGS, 28 and 2C, lelless 170 are ‘movable between an open configuration (FIG. 2B) and @ closed configuration (FIG, 20) in which the leaflets eoapt, or ‘meet in scaling abutment. [041] At the lower, or ventricle end, leaflets 170 may have a smaller perimeter than outer covering 160. Thus, the Ire lower edges of the leaflets, between commissure posts 182 (each portion of leaflets 170 between adjacent com sre posts heing refered to a8 a “bell” of leaflets 170) are spaced radially from the lower edge of outer covering 160. This radial spacing facilitates movement of the leaflets ro the open position in FIG. 2B to the closed pesition in FIG. 2C, asthe counter flow of blood from the ventricle to the atrium during systole can eatch the free edges of the bellies ‘and push the leaflets close. [0042] Outer covering 130 and inner covering 132 of outer fame 120, outer covering 160 and leaflets 170 may be ‘ormed of any suitable material, or combination of materials In some embodiments, the tissue is optionally a biological tissue, such as a chemically stabilized tissue from 1 heart valve ofan animal, sch asa pig, or pericardial tissue of an animal, such as cow (bovine pericardium), sheep (ovine pericardivim), pig (porcine pericardium), or horse (equine pericardium). Prelerably, the tissue is bovine pericarlial tissue. Examples of suitable tissue include that used in the products Duraguard’, Per-Guard®, and Vascu-Guard® all products currently used in surgical procedures, and which fare marketed as being harvested generally from cattle less than 30 months old. Alternatively, valve leaflets 170 may ‘optionally be made from pericardial tissue or smal intestine submucosal (SIS) tissue [0043] Synthetic materials, such as polyurethane or poly- fetrafluoroethylene, may also be used for valve leaflets 170 ‘Where a thin, durable symtetie material is contemplated,US 2018/0271651 Al ‘eg. for outer covering 130 or inner cover 132, synthetic polymer materials such expanded polytetrtiuoroethylene oF polyester may optionally be used. Other suitable materials may optionilly include thermoplastic polycarbonate une- thane, polyether urethane, segmented polyether urethane, silicone polyether urethane, silicone-polsearbonte ure thane, and ultra-high molecular weight polyethylene. Addi tional biocompatible polymers may optionally include poly- olefins, elastomers, polyetiylene-glyeois, polyethersulpbones, polysulphones, polyvinylpyrrolidones, polyvinyichlrides, other fluoropolymers, silicone polyes- ters, siloxane polymers and/or oligomers, andlor polylae tones, and block co-polymers using the same, 0044} In another embodiment, valve leaflets 170. may ‘optionally have a surface that has been treated with (oF reacted with) an anti-coagulant, such a, without limitation, ‘immobilized heparin, Such currently available hepatinized polymers are known and available toa person of ordinary Sill i the at [0045] As shown in FIGS. 1A, 1B, and 2A, inner valve assembly 140 may be substantially eylindrical, and outer fame assembly 10 may be tapered, extending from smaller diameter (lightly larger than the outer diameter of ier valve assembly 140) ata lower, ventricle portion 112 (here its coupled to inner valve assembly 140) to a larger diameter, atrium portion 116, with an intemnediate diameter ‘annulus portion 114 between the atrium and ventricle por: 10045] A tapered annular space or pocket 186 is thus formed berwcen the outer surface of inner valve assembly 140 and the inner surface of outer frame assembly 110, open to the atrium end of valve assembly 100, When valve assembly 100 is disposed in the annulus of a native hear, valve, blood from the atrium can move in and out of pocket 185. The blood can clo, forming thrombus, and the throm- bus can be washed out by the Row of blood during the eyelic pumping ofthe heat, which is undesirable, To inhibit such ‘washout of thrombus, and to enhance elotting, ingrowth of tissue into the surfaces of valve 100, and produce other benefits, the pocket can be covered, or enclosed, by a pocket closure 180, [0047] Pocket closure 180 can be formed at leat in part of any suitable material that is suticiently. porous to allow blood, including particularly red blood cells, to enter pocket 4188, but is not so porous a to allow undesirably lange thrombi to leave the pocket 188, or 1 allow washout of thrombus fommed in the pocket 188. For example, pocket ‘closure 180 may be formed at least in part from a woven oF knit polyester fabric with apertures less than 160q, and preferably between 90j andl 120) Tis aot necessary forthe ‘entirety of pocket closure 180 to be formed of the same material, withthe same porosity. For example, some por tions of packet closure 18 may be formed of less porous, ‘or blood impermeable, material and other portions formed of material of the porosity range noted above. It is also con- templated that # portion ofthe outer frame assembly 110 oF the inner valve assembly 140 maybe formed with an ‘aperture that communicates with pocket 180, covered by 2 ‘closure formed of material having the desired porosity, thus providing another path by which blood may enter, but thrombi are prevented from leaving, aval pocket 185. [0048] The outer surface of inner valve assembly 11, and/or the inner surface of outer fame assembly 140, noed Sep. 27, 2018 FIGS. 1A and 1B, but may be of non-constant radius at a aiven location along the central axis of valve 100, Ths pocket 188 nay not be of constant cross-section, and may ‘ot be continuous, but rather may be formed in 0 or more ‘uidieally isolated, partially annular volumes. Similarly, pocket closure 180 need not he shaped as a ring wilh feonstat wich a shown schematically in FIGS, 1A and 1B, bt rather can he a continios ring of varying width, a more complicated eontinvous shape, oF may be formed in mul- tiple, discrete sections. [0049] Pocket closure 180 serves to trap andor slow the flow of blood within pocket 185, reducing hemodynamic ‘washout and inereasing formation of thrombus in pocket 185. It also promotes active in-growth of native tssbe into the several coverings of prosthetic heat valve 100, farther stabilizing valve 100 in the native heart valve, The material Torming the outer covering of ina valve assembly 140 can also be hardenod or sitfened, providing better support for Teaflets 170, Also, a mass of thrombus filling pocket 185 can serve as potting for inner valve assembly 140, further Stabilizing the valve assembly. Greater stability for inner valve assembly 140 can provide more reliable coaption of valve leaflets 170, and thus mote effective peeformatice. The ‘mats of thrombus can also stabilize the outer frame assem- bly 110 afer it has been installed in, and Mexily conformed to, the native valve apparatus. This can provide a more effective seal between prosthetic heart valve 100 and the ‘ative valve apparatus, and redice perivalvilar leakage. [0050] One possible implementation of the prosthetic heart valve shown schematically in FIGS. LA-2C is pros thetic heart valve 200, shown in top view in FIG. 3 Prosthetic heart valve 200 incindes an outer frame assembly 210 and an inner valve assembly 240 coupled to the outer frame assembly. [O51] The cuter frame assembly 210 includes an outer ame 220, covered on all a a portion ofits outer face with ‘an outer covering 230 (aot visible), and covered on all or @ portion of its inner face by an inner eovering 232 [0052]. The inner valve assembly 240 includes an inner Tame 280, an outer covering 260 (not visible), and leaflets 270. Toner frame 250 incindes six axial posts or frame ‘members that support outer covering 260 and leaflets 270. The inner valve assembly 240 may be substantially cylin- Grical, and outer frame assembly 210 may be tapered extending ftom a smaller diameter (lightly larger than the ‘outer diameter of inner valve assembly 240) at « lower, ‘ventrile portion (where it is coupled to inner valve assem- bly 240) to a larger diameter, atrium portion, with an intermediate diameter, annulus portion between the atrium and ventricle portions [0053] tapered annular space or pocket 288 (eg. atrial thrombogenic sealing pocket) is thus formed between the ‘outer surface of inner valve assembly 240 and the inner surface of outer frame assembly 210, open to the atrium end of valve assembly 200. The pocket closure 280 can, for ‘exaniple, be formed from a circular piece of wire, or halo, ‘with a permeable mesh fabric or tissue, that is sewn and thereby’ connected to the inner frame 280 and/or to the Jeaflets 170, The inner frame 280 has an inner wireframe structure (eg, made of Nitinol wire) that supports the Teaflts 270 sewn tothe inner frame 250 and functions as @ valve, The inner frame 260 in FIG, 3 includes three Leshapesd wire components joined at their opened ends to orm junctions, Leaflets 270 are sewn to these componentsUS 2018/0271651 Al ‘o form articulating leaflets 270 creating and fonet prosthetic valve (eg. prosthetic tricuspid valve: p rial valve; prosthetic sortie valve, et) 0054) Moreover, the inner frame 280 has (Jeter) attach- ‘ment apertures 211 (aot show), for ataching tether ass bly 290 (not shown). Tether assembly 290 is connected 10 ‘epicardial securing pad 254 (not shown), 10055] In operation, the inner valve assembly 240 is disposed within and secured within the outer frame assem= bly’ 210, Outer frame assembly 210 may also have in various ‘embodiments an outer stent tissue material, Outer frame assembly 210 inclodes an articulating collar 246 which has ‘collar cover 248, Ariculating collar 246 is specifically ‘shaped to solve leakage issues arising from native structures. In particular, collar 246 is composed of an A2 segment 247, ‘8 P2 segment 249, and two commissural segments, the ALDI segment 251, and the A3-P3 segment 288, The collar 246 may also have in preferred embodiments a shortened of fattened or D-shaped section 262 ofthe A2 segment in order 'w accommodate and solve left ventricular outflow tract (LVOP) obsicuetion issues, 10056] _In operation, the prosthetic heart valve 200 may be deployed (eg. sa prosthetic mitral valve) using catheter delivery techniques, The prosibetic heart valve 200 is com= pressed within a narrow catheter and delivered to the annul region of the native valve (e.g. the fet atrium) with & pre-attached ther assembly 290, There, the valve 200 is Pushed out of the catheter where it springs open into its pre-formed Functional shape without the aged for manual ‘expansion (eg, manual expansion using an inner balloon, catheter). When the valve 200 is pulled into place, the outer frame assembly 210 is seated jn the native mitral annulus, Jeaving the articulating collar 246 to engage the atial floor and prevent pull-tru (where the valve 200 is pulled ito the ventricle). In such embodiments, it is not necessary 10 ‘cut-away the native leaflets, as has been taught in prior prosthetic efforts, Instead the native leaflets ean be used 10 Provide a tensioning andlor sealing fition around the ‘outer frame assembly 210. Its advantageous forthe valve 200 to be asymmetrically deployed in order to address LVOT problems where on-accommodating prosthetic valves push against the A2 anterior segment of the valve (eg, mitral valve) and close blood fHow through the aorta, ‘hich anatomically sts immediately behind the A2 segment ‘of the mitral anaulus, Thus, D-shaped section 262 is ‘deployed substantially immediately adjacenVcontacting the |A2 segment since the flattened D-shaped section 262 is ‘troctimlly smaller and has 8 more vertical profile (loser to paralleling the longitudinal sais of the outer Irame assembly 212) and thereby provides less pressure on the A? segment ‘Once the valve 200 is properly seated, tether assembly 290 may’ be extended out through the apical region of the left ventricle and secured using an epicardial pad 254 or similar suture-locking attachment mechanism (not shown) 10057] In an altemate embodiment, the tether assembly 200 is on the outer frame assembly 210, which would thea have (tether) attachment apertures 213 far attaching tether assembly 290 to epicantial securing pad 264 [0088] FIG. 4 is atop, or atrial, view of another emboxt- ment of a prosthetic hear valve 300, ilstrated without pocket closine 380. FIG. 4 shows the top ofthe junetion tip 502 ofthe three Ucshuped wire components of faner frame ir opened ends to form junctions 302. n to these components to form aricu- Sep. 27, 2018 Jating leaflets 370 creating and functioning as a prostet valve (eg, prosthetic tieuspid valve, prosthetic mit valve, prosthetic aortic valve, «t.). Thrombogenic pocket 235 is shown below the plane of the collar. FIG. 4 shows vertical A2 segment 347, the P2 segment 349, and the commissural A1-PI segment 381 and A3-P3 segment 383. FIG. 4 shows how upon deployment blood! would fill the void or gap 385 between the inner valve assembly 340 and the outer frame assembly 319 ofthe valve 300, This blood creates a temporary fluid seal that pools in that space and provide a pressure buffer agains the leakage inducing forces that accompany systolic and diastolic elated intra-atral and jntra-ventricular pressure. Moreover, FIG. 4 provides an illustation of collar 346 that may. in some embodiments ‘include a shortened or Rsttened or D-shaped section 362 of the A2 segment in order to accommodate and solve left ventricular outlow tract (LVOT) obstruction issues. [0059] FIG. Sis perspective side view ofthe P2 area 447 fand AB-P3 area 483 of a selFexpanding pre-configured compressible transcatheter prosthetic cardiovascular valve +400 contemplated herein, that contains as sub-componert fa sel-expanding inner valve assembly 440. The valve 400 further includes asa sub-component, an outer frame assem bly 410, The outer frame assembly 410 and the inner valve assembly 440 collectively define thrombogenic pockets 485. FIG. 8 shows one of the three U-shaped wire components of ‘nner frame 450 joinod at their opened ends to form june- tions 402, Leaflets 470 are sewn to these componeats to orm articulating leaflets 470 ercating and functioning as a prosthetic valve. Thrombogenie pocket 488. is shown Slightly below the plane of the majority of ollar 446 except {orthe venical A2 segment 447, the P2 segment 449, andthe commissural AI-PI segment 451 (not shown) and A3-P3 segment 483. FIG. § shows how upon deployment blood ‘would ill the void or gap (i.e pocket 485) between the inner valve assembly 440 and the outer frame assembly 410 at the .A3-P3 seament 453 area ofthe valve 400, This blood creates ‘temporary Muid seal that would pool in that space and provide pressure butfer against the Teakage inducing forces that accompany systole and diastolic elated intr-atral and inra-ventricular pressure. [0060] FIG. 6 is an exploded view of an embodiment of the pre-configured compressible transcatheter prosthetic car ovascula valve 400, which contains at a sub-componert, a selfexpanding ioner frame 450. The valve 400 further Includes as a sub-component, an utr frame assembly 410. The outer frame assembly 410 and the inner valve axsernbly 440 collectively define thrombogenic pockets 488 (not shown). The pocket 485 is formed botwoon inner valve assembly 440, a8 the inside of the Vshaped or Usbaped pocket, and the outer frame assembly 410 with outer cov- fering 430, a¢ the outside of the V-shaped of U-shaped pocket In this valve 400, the inner valve assembly 440 has ‘an atrial thrombogenic sealing. pocket closure 480 (not shown) (eg. formed! from a eicular pie of wire, or hal), ‘with a permeable mesh fabric or tissue, that is sewn and thereby’ connected to the inner frame 450 and/or to the leaflets 470, The inner frame 480 inclndes an innee wire frame structure made of Nitinol wire that supports Iaflets 4470 sewn to the inner frame 450 and funetions a8 a valve ‘The inner frame 450 includes three main U-shaped wire ‘components 407 joined at their opened ends to form june-US 2018/0271651 Al tions 402, Optionally in some embodiments the ier frame 450 can include additional wire cross-members or struts (eg, more than three), 10061] In this valve 400, the inner ame 450 is sewn with tissue and acts cover to prevent valvular eakage. The inner valve assembly 440 includes the leaflets 470. The leaflets 4410 inchude articulating leaflets that define a valve function, “The leaflets 470 are sewa tothe inne frame 480, The inner fame 480 also hs (tether) atuchment apertures 411. for attaching tether assembly 490, Tether assembly 490 is, shown in this example as connected to epicardial securing pad 454. In operation, the covered inner valve assembly 440 (vith leaflets 470, i disposed within and secured within the ‘outer frame assembly 410. Outer frame assembly 410 may also have in various embodiments an outer covering 460 ‘Outer frame assembly 410 has an articulating collar 446 Which hae a collar cover 448. Amiculating colar 446 may also have in preferred embodiments «fattened or D-shaped scction 462 at the A2 area to accommodate and solve left ventricular outfow tract (LVOT) obstniction issues. Colla 446 may also have specially formed commissural segments to prevent commissural leakage at AI-PI segment 451 and at APS segment 453 10062] In operation, the valve 400 may be deployed as @ prosthetic valve using catheter delivery wehnigues, The valve 400 is compressed within a naow catheter and delivered o the annular region of the native valve (eg. the Jeft atrium) witha pre-ttached tether assembly 490. There, the valve 400 is pushed out of the catheter where it springs ‘open into is pre-onmed functional shape without the need {or manual expansion (es. mansall expansion using an inaer balloon catheter. When the valve 400 js pullod int place, the outer frame assembly 410 is seated in the native annulus (eg, native mitral annulus), leaving the aniculating collar “446 to engage the atrial floor and prevent pullthns (where the valve is pulled into the venriele). In such embodiments, itis nt necessary to cut-away the native leaflets as as been ‘aught in prior prosthetic effos. Instead, the native Teaflet ‘can be Use 1 provide a tensioning andor sealing funeto around the valve 400 (e-., around the outer frame assembly 410). 1s advantageous forthe valve 400 to be asymmere cally deployed in order to address LVOT problems where ron-accommodating prosthetic valves push against the A2 anterior segment of the valve (eg. the mitral valve) and ‘lose blood flow through the aorta, which anatomically sits immediately behind the A2 segment of the anaslas (eg miteal annulus. 10063] ‘Thus, D-shaped section 462 is deployed substan- ‘ally immediately adjacea/contacting the A2 segment since the flattened D-shaped section 462 is structurally smaller ‘and has. more vertical profile (closer to paruleling the Jongitudinal axis of the Outer frame assembly 410) and thereby provides less pressure on the A2 segment. Once the valve 400 is propery seated, tether assembly 490 may’ be ‘extended out through the apital region of the let ventricle and secured using an epicardial pad 484 or similar suture- Jocking attachment mecbanism, 10068] FIGS, 7.9 are ft, bottom, and top views, respec- Lively, of a prosthetic heart valve 300 according aa ‘embovtiment. [0065] Prosthetic heart valve 00 is designed to replace @ damaged or diseased native heart valve steh as mite Sep. 27, 2018 valve, Valve $00 cludes an outer frame assembly 510 and an inner valve assembly $40 coupled 10 the outer frame assembly $10, [0066] As shown, outer frame assembly S10 includes an ‘outer Irame $20, covered on all oa portion of ts outer Face ‘with an outer covering 530, and covered on all ora portion ofits inner face by an inner eovering $32. [0067] Outer fame $20 ean provide several functions for prosthetic heart valve 800, including serving asthe primary Structure, as anchoring: mechanism and/or an attachment point for a separte anchoring mechanism to anchor the valve to the native heart valve apparatus, a suppor 0 carry inner valve assembly $40, and/or a seal to inhibit paraval- volar feakoge between prosthetic heart valve $00 and the ative heart valve apparatus [0068] Outer frame 520 is configured to be manipulated andlor deformed (e., compressed andlor expanded) an. ‘when released, return ois original (undeformed) shape. To achieve this, outer frame 820 can be formed of materials, sch as metals or plastics, that have shape memory proper. ties. With regards to metals, Nitnol® has been found t9 be especialy useful since it can be processed to be austenitic, ‘martensitic oF super elastic. Other shape memory alloys sueh as Co—Zn—AI—-Ni alloys, andl Co—AI-Ni alloys, may be used [0069] As best shown in FIG. 7, outer frame assembly $10 fas an upper end (e.g. atthe atrium portion 16), 2 loser end (eg. atthe venticle portion $12), and a medial portion (ex atthe annslus portion $14) therebetween, The media portion of the outer frame assembly $10 has a perimeter that Js configured (e., sized, shaped) to it into an annulus of 2 tative atrioventricular valve, The upper ead of the outer frame assembly $10 has a perimeter that is larger than the perimeter of the medial portion. In some embodiments, the perimeter ofthe upper end ofthe outer frame assembly S10 ‘has a perimeter thats substantially larger than the perimeter ‘ofthe medial portion, As shown best in FIG. 9, the upper end and the medial portion of the outer frame assembly 510 has 4 Deshaped cross-section, In this manner, the outer frame assembly $10 promotes a suitable fit into the annulus of the tative alrioventicula valve. [0070] Inner valve assembly $40 includes an inne fran '0, an outer covering $60, and lealets $70. As shown, inner valve assembly $40 includes an upper portion having a periphery formed with mukipe arches. The inner frame ‘550 includes six axial posts or frame members that support ‘outer covering S60 and Jeaflets $70. Leaflets S70 are attached along three of the posts, shown as commissure posts $52 (bes illustrated in PIG. 8), and auter covering 560 Js atlached to the other three posts, $S4 (best illustrated FIG. 8), and optionally to commissure posts $82. Each of ‘outer covering 560 and leaflets 870 ate formed of appeoxi- rately rectangular sheets of material, whiel are joined together at their upper, or atrium end, The lower, ventecle cen of outer covering S60 may be joined to inner covering 532 of outer frame assembly $10, and the lower, ventricle end of leaflets $70 may form fee edges 875, though coupled to the lower ends of commissure posts 52. [0071] Although inner valve assembly S40 is showen as having three leaflets, in other embodiments, an inner valve assembly can include any suitable number of leaflets. The leaflets $70 are movable hetween an open configuration and 4 closed configuration in which the lealets 570 coapt, oF peet in a sealing abutmentUS 2018/0271651 Al 10072] Ac the lower, oF ventricle end, leaflets $70 may have a smaller perimeter than outer covering 60. Thus, the Ire lower edges of the leaflets, between commissure posts 582 (cach portion of leaflets 70 between adjacent comimis- ‘ute posts boing referred 10 asa “holy” of Teles $70) aro spaced radially irom the lower edge of outer eovering $60 of the inner valve assembly $40, This radial spacing facilitates ‘movement ofthe leaflets 870 fom the open postion to the ‘closed postion a8 the countefiow of blood from the ven= tricle to the atrium during systole can catch the fre edges of the bellies and push the leaflets §70 closed (e-. coapt). 10073] -Outee covering $30 of the outer frame assembly S10 and inner covering S32 of ovter frame assembly SU, ‘outer covering $60 of the inner valve assembly $40 and leaflets 70 of the inner valve assembly S40 may be formed ‘of any suitable material, or combination of materials, suchas those discussed above. In this embodiment, the inner cov- ‘ering $32 of the outer frame assembly S10, the outer ‘covering $60 of the inner valve assembly S40, and the Jeaflts 570 ofthe innee valve assembly $40 are formes, at least in part, of porvine pericanium. Moreover, in this ‘emboviiment, the outer covering 830 of the outer frame ‘assembly S10 is formed, at least in par, of polyester, 10074) "In another embodiment, valve leslets $70. may ‘optionally have a sueface that has been eated with (oF reacted With) an ant-coagulant, such as, without Hinitation, ‘immobilized heparin, Such currently available heparinized polymers are known and available to person oF ordinary Still in the at [0075] _Ioner valve assembly 540 js substantially eylindi- cal, and outer frame assembly 810 js tapered, extending fom a smaller diameter (slightly larger than the outer «diameter of inner valve assembly $40) ata lower, ventricle portion $12 (where itis coupled to inner valve assembly 540) to a larger diameter, sium portion 516, with an Inlermediate diameter, annulus portion S14 between the ‘atrium and ventricle portions. [0076] As show, a tapered annular spece or pocket S85 is thus formed hetween the outer surface oF nner valve assen- bly S40 andthe inner surface of outer frame assembly S10, ‘open to the atrium end of valve assembly 800, As shot pocket closure $80 is coupled along the periphery of the Uupper end of the inner valve assembly $40, In some embod mens, the pockst closure 580, ora portion thereof, can be ‘coupled along any suitable portion ofthe inner valve assem- by $40, 10077] As discussed above, pocket closure $80 can be formed at least in part of any suitable material that is sulicently porous to allow blood, including particulary red blood cells, to enter pocket 885, but isnot so poros as to allow undesirably large thrombi to leave the pocket 85, or to allow washout of thrombus formed inthe pocket 585. In this embodiment, pocket closure 580 is formed entirely of knit polyester (ie., PET warp knit fabrie) having apertures ‘of about 90-120 microns, In some embodiments, & pocket ‘closure ean include apertures less than abot 160 microns. 10078} Inner frame $80 is shown in more deal in FIGS. 10-12. Specifically, FIGS. 10-12 show inner frame $50 in 20 undeformed, initial state (FIG. 10), side view of the inner fame 880 in a deployed configuration (FIG. M1), and & bottom view of the inner frame S80 in a deployed configu- ration (FIG. 12), respectively, according to an embodiment. 10079] In this embodiment, inner frame $50 is formed fiom a lasercut tube of Nitinol, Taner frame 850 is Sep. 27, 2018 illustrated in FIG. 10 in an undeformed, laser-cul, but cut and unrolled into a lat shoot for eave of illustration. Inner frame $80 can be divided iato four po tions, comesponding to functionally diferent portions ofthe inner frame 50 in final form: atrial portion S41, body portion $42, strut portion $43, and tether elamp portion $44 Strut portion $43 includes six struts, such as stout 543A, ‘which connect body portion S42 ta tether elamp portion S44 [0080] Connecting portion $44 includes. longitudinal extensions ofthe siuts, connected circumferential by pairs ‘of opposed, slightly Vshaped connecting members. (or “miero-Vs"), Comecting portion 54 is configured to be radially collapsed by application of compressive force which causes the miero-Vs to hacome more deeply ‘shapes, with the vertices moving closer together longi nally and the open ends of the V shapes moving, closer together circumferentially. Thus, connecting portion $44 can be configured to compressively clamp or grip one end of a tether, either connecting direely onto a tether line (e-, braided filament line) or onto an intermediate structure, sue ‘asa polyner of metal piece that isin tim fmm fsed to the tether line, [0081] In contrast to connecting portion 54, atrial portion S41 and body portion $42 are configured to be expanded radially, Strut portion $43 forms 2 longitudinal connection, ‘and radial transition, besween the expanded body portion and the compressed connecting portion S44, [0082] Body portion 542 incites six Tongitutinal posts, such as post 842A. The posts ca be used to aac Jeallets '570 o inner frame 540, andior can be used to attach inner assembly $40 to outer assembly 810, such as by connecting jnner frame $80 10 outer fame $20. In the illustrated embodiment, the posts include openings through whieh ‘connecting members (such as suture filaments andr wiees) can be passed t0 couple the poss to other structures. [083] "Inner frame $50 is shown in a fully deformed, i. ‘o the final, deployed configuration in side view and bottom view in FIGS. IT and 12, respectively. [0084] Outer frame $20 of valve 500 is shown in more Stalin FIGS. 13-15, In this embodiment, outer frame 520 is alto formed froma lasercut tube of Nitinol®, Outer frame $520 js illustrated in FIG. 13 in an undeformed, initial state, ile as laser-cu, but cut and uarelled inte a fat sheet fr ease of illustration, Outer frame $20 can be divided into a coupling portion $71, a body portion $72, and a eulT portion 573, as shosin in FIG. 13. [0085] Coupling portion $74 includes multiple openings Drapertures, such as 8714, by which outer frame $20 can be feoupled to inner frame 860, as discussed in more detail below [086] Outer frame 520 is shown in filly deformed, i. to the final, deployed contiguration, in side view and top view in FIGS, 1 and 18, respectively. A best scen in FIG. 15, the lower end of coupling portion 871 forms a roughly circulue opening (identifi by "0" in FIG. 18), The diam- ter ofthis opening preferably corresponds approximately t0 the diameter of body portion $42 of inner frame $50, 10 ‘cilitate coupling of the two components of valve 500, [0087] Outer frame $20 and inner frame S80 ane shoxen ‘coupled together in FIGS, 16-18, in front, side, and top views, respectively. The two frames colletvely form a siruetiral support fora prosthetic valve such as valve $00. ‘The frames support the valve leaflet structure (eg. Ieaflets 570) in the desied relationship tothe native valve annulus,US 2018/0271651 Al support the coverings (e., outer covering $20, inner cov- ‘ring 532, outer covering 860) forthe two frames to provide a barrier fo blood leakage between the atrium and ventricle, ‘and couple to the tether (eg. tether assembly £90) (by the ‘nner frame $50) to aid in Holding the prosthetic valve in place inthe native valve annulus by the tether connection to the ventricle wall, The outer frame 520 an the inner frame 350 are connected at six coupling points (representative points are identified as "C"). In this embodiment, the Pling points are implemented with a mechanical fstener, Such a a short length of wire, passed through an aperture (Guch as aperture S71) in coupling portion S71 of outer fame 820 and corresponding openings in longitainal posts (uch as post $42) in body portion $42 of in frame S80. Inner frame S80 i ths disposed within the oute fame 520 and securely coupled to [0088] A. template 834 (or design pattem) for cutting, shaping, and sizing omter covering 530 of outer frame assembly S10 andlor inner covering $32 of onter frame assembly is illustrated in FIG. 19, according to an embod ‘ent, Design pattern 834 includes attachment location indic ‘ations $360, $366, To arrange outer covering 540 into an sssembled configuration (.e, either coupled to oF ready to be coupled to outer lrame $20), the evo ends of the outer ‘covering $80 ae coupled together (e.g, sewn) in aecondance ‘withthe attachment location indications 5362, 5365 of the template 534. Similarly, inner covering $32 is arranged into an assembled configuration by coupling (eg, sewing) its ‘ends together in accordance with the attachment location indications 5360, 536 10089] FIG. 20 illustrates a design pattem of one leaflet $570 and associated portion of outer covering 560 of the inner valve assembly in its inital, pre-assembled state (Le, not sitached to inter frame 580), according to an embodiment. AAs discussed above, the portion of leaflet $70 between adjacent commissure posts is refered 10 a5 a “belly” of the leaflet $70. The belly has a curved edge indicated with reference ‘Bin FIG. 20, During assembly of inner valve ‘assembly S40, the leaflet $70 is coupled to the inner frame 580 of the inner valve assembly $40. Specifically, the belly ‘edge B of the leaflet $70, ora portion thereof, is coupled t0 the inner frame $0 atthe arch portion ofthe inner frame 560. In addition, outer covering $60 is folded over portion ‘of the inner frame 850 (e.g, the arch portion) along the axis, Indicated with “F*, and coupled to a portion of the inner fame 850 (e.., the commissure post $82) along attachment Tine A. As shown, a coupling area C (ea stching ara) js disposed outside and adjacent t© attachment line A. ‘Coupling ates C can Facilitate the assembly process, Subs sequently, excess leaflet material andor excess outer cov= ‘ering material can be cut away and disposed of or reused. For example, material disposed between the belly edge B ‘and the F-axis, or material in the eoupling area C, may, in some embodiments, be unnecessary material and thus can be ‘cut assay from te leaflet $70 and/or outer covering 360. The fssembly process can he repeated fr each leaflet $70, cach ‘outer covering 560, and each commissure post 552. 10090] The leaflets $70 and the outer covering $60 can have any suitable size, shape, material, andor configuration. For example, in this embodiment, leallets $70 andior outer ‘covering $60 is formed of fixed poreine pericardium, with 3 thickness of about O01 inches, [0091] A schematic representation of another embodiment ‘of prosthetic heart valve is shown in FIGS, 21 and 22, Sep. 27, 2018 Prosthetic heart valve 600 is designed to replace a damaged or dscased native heart valve such as a mitral valve. Valve {600 includes an outer ame assembly 610 and an inner valve assembly 640 coupled to the outer frame assembly 610. 0092} "Although not separately shown in the schematic illustration of outer frame assembly 610 in FIGS. 24 and 22, ‘ter frame assembly 610 may he formed of an ter frame £620, covered onal ora portion ofits outer fae with an outer covering 630, and covered on all ora portion ofits inner face by an inner covering 632. The materials and eoustruction of the components of prosthetic heart valve 600 can be sislar to those of the other embodiments described above, The following discussion focuses on the aspects of this embodi- ‘ment that difler from the previous embodiments, [093] Inner valve assembly 680 includes {650 (not show), an outer covering 660 (at (670 (not shown), and atrial structure 6§8 (e.., halo). As shown, the halo 685 is disposed atthe atrium portion 616 of inner valve assembly 640. In such a configuration, when valve 600 is implanted into a eat of» patient, halo 5 wil be disposed above the atrial oor andr native valve ann Jos of the patient's heart, In this manner, the halo 685 provides extended functionality (eg., above the native ‘mitral valve anaulus) of the inner frame 680. In some instances, for example, if prosthetic leaflets are seated 100 low relative 0 the native valve annulus, the leaflets may ‘improperly eoapt (eg, ineomplete coaptation) andor hemo- dynamic Teakage can oocur, Thus, disposing balo 68S above the native valve annulus can provide for andlor promote ‘complete eoapation. [094] Halo 635 can be formed from aay’ suitable method ‘and material. For example, in some embodiments, halo 688 fan be formes! from a substantially cireular picoe of Wire. la such embodiments, halo 658 can be coupled 1 (eg, Sewn) to inner frame 650. [0095] Outer covering 630 and inner covering 632 of outer frame 620, outer covering 660 and leaflets 670 may be ‘formed of any suitable material, or combination of materials such as those discussed above in connection with other embodiments 0096] As shown in FIGS. 21 and 22, inner valve assen bly 640 may be substantaiy eylindresl, and outer frame assembly 610 may be tapered, extending fom 2 smaller ameter (slightly larger than the outer diameter of inner valve assembly 640) ata lowe, ventricle portion 612 (where it is coupled to inner valve assembly’ 640) to larger ameter, atrium portion 616, with an intermediate diameter, fnnulvs portion 614 between the atrium and ventrile por ‘ions. [0097] In some embodiments, the outer surface of inner valve assembly 610, andor the inner surface of outer frame assembly 640, ned not be circular in cross-section as shown schematically in FIGS. 21 and 22, but may be of non- constant radius ata given location along the centeal axis of valve 600. [0098] The alist halo 6§5 functions by extending the inner frame of an inner valve assembly above the plane of arial floor in an improved prosthetic heart valve that Jncludes an inner frame that holds the leaflets and which is disposed within an outer frame for reducing or preventing leaking when the prosthetic heart valve is dispossd within a heart valve (et, mitral valve, tricuspid valve). [0099] benefit to having leaflets within a raised leaflet silo or eylinder (eg, halo 680) is improved blood flow andUS 2018/0271651 Al leaflet closure, It as been observed that where the leaflet cylinder isa the trial lor, lett coaptation is incomplete ‘and ean result in hemodynamic leakage [0100] Accordingly. by providing an atrial halo or ring structure that is raised above the plane of the native annulus ‘or atrial floor, complete leaflet coaptation is encouraged. During ventricular contraction or systole, the blood. is ‘jected towards the aortic valve o exit the hean but is also ‘jected towards the prosthetic mitral valve, which needs 10 remain closed during systole. Retrograde blood hiting the prosthetic valve leaflets cause the leaflets to clos, prevent {ng regurgitation into the left atrium, During disstole oF ventricular filing, the blood needs to flow from the atrium ino the ventricle without obstmicton. However, whea prose thetic leaflets are not propery placed or properly aligned, the leaflets can obstruct ecient filing of the ventricle or cause Uuneven ventricular output [0101] FIG. 23 is a top-view of a prosthetic heart valve 700 acconling to an embodiment that is one possible imple- mentation of the prosthetic heat valve shown schematically Jn FIGS, 24 and 22. Prosthetic heart valve 700 includes aa ‘outer frame assembly 710, an inner valve assembly 740, and ‘2 telher assembly 790. The inner valve assembly 740) ‘inchides an inner frame 750, and outer covering 760 (not shown), leaflets 770, and atrial structure 788 (e.., halo) Halo 75 can be formed from a eircolar piece of wire that ‘can be connected to the inner Frame 750 and sewn to the leaflets 770. The inner frame 750 can be made of Nitinolle Wire that suppons lealets 70 sewn to the inner frame 750 in funetions asa valve. The inner frame 780 shown in FIG. 23 includes three U-shaped wire components joined at teie ‘opened ends o form junctions 702. Leaflets 70 are sewn to these components to form aniculating leilets, creating and functioning as a prosthetic valve (e., prosthetic mitral valve, prosthetie ticuspid valve). 10102] In some embodiments, the inner frame 750 has Tether attachment apertures 71H (aot showa) for attaching tether assembly 790, Tether assembly 790 is connected to ‘epicardial securing pad 784 (not shown, 10103] In operation, the inner frame 780 (with leaflets ‘710, is disposed within and secured within the outer frame 720 of the outer frame assembly 710, Outer frame 720 includes an outer covering, 730 (not shown) (e-., tissue material) and an inner covering 732 (eg. tissue material). ‘Outer frame 720 has an articulating collar 746 which has 3 collar cover 748, Articulating collar 746 = configured (e. shaped and sized) to solve leakage issues arising from native siructurs. In panicular, collar 746 is composed of an A2 segment 747, a P2 segment 749, and two commissural Segments, the AL-PL segment 751, and the A3-P3 segment 753. The collar 746 may also have, in some embodiments 2 shortened or flattened or D-shaped section 762 of the A2 Segment in order to accommodate and solve left ventrculae cutlow tract (LVOT) obstruction issues. 10104] In operation, the valve 700 may be deployed as @ prosthetie mitral valve using catheter delivery technigues. The entire valve 700 is compressed within a narrow eatheter and delivered (0 the annular region of the native valve, proferably the fet atrium, with a pre-attachod tether appa ratus. Upon dlivery, the valve 700 is pushed out of the catheter where it springs open into its pre-formed fanetional shape without the need! for manual expansion (eg, mana ‘expansion sing an inner halloon catheter). When the valve 7700 is pushed andlor pulled into place, the outer frame Sep. 27, 2018 assembly 710 is seated in the native valve annulus (e., ‘ative mitral angulus), leaving the articulating collar 746 ‘engage the tral lor and prevent pull-through (where the valve is pulled into the ventricle). In such embodiments, i isnot necessary to cutaway the native leaflets, as has been ‘aught in prior proseti ells, Instead, the native leaflets ‘ean be used to provide a tensioning andior sealing function around th outer frame assembly 710, It is advantageous for the valve 700 to be asymmetrically deployed in onder to address LVOT problems where son-iccommodating pros: thetic valves push against the A2 anterior segment of the valve (e, mitral valve) and close blood flow through the ‘aorta, which anatomically sits immediately behind the A2 segment ofthe mitral annulus. Thus, D-shaped section 762 is deployed substantially immediately adjacenvcontacting the A2 segment since the lattened D-shaped section 762 is structurally smaller and has more vertical profile (loser to paralleling the longitudinal axis of the outer stent) and thereby provides less pressure on the A2 segment. Once the valve 700 is propery seated, tether assembly 790 may’ be extended out through the apical region ofthe left ventricle fad secured using an epicardial pad 754 or similar suture locking attachment mechanism (not shosn), [0105] In an altemate embodiment, the tether assembly 790 son the outer frame 720, which would then have ether attachment apertures 713 for attaching tether assembly 790 to epicardial securing pad 754, [0106] FIG. 24 is a perspective view of the AL-PI side of the prosthetic heart valve 700 according to an embodiment. FIG. 24 shows one ofthe three U-shaped wire components of inner frame 780 joined at their opened ends to form junetions 702, Although three U-shaped wire components fare showin, in other embodiments, any suitable number of ‘Usshaped vite components can be joined at theie opened ends to form junctions. Similar in some embodiments, the ‘wire components of inner frame 750 can be any suitable shape or size, Leaflets 770 are sewn to these components to form articulating leaflets 770 creating and funetioning 3s a prosthetic heart valve (eg, mitral valve, tricuspid valve) Atrial halo 758 is shown with the plane ofthe circular wire hove the plane of the majorly of collar except for the vertical A2 segment 747, the P2 segment 749, and the commissural A1-PL segment 781 an A3-P3 segment 783. FIG. 26 shows how upon deployment blood would fill the void or gap 707 betwcen the inner frame 750 and the outer frame 720 a1 the AI-PI segment 751 of the valve 700. This blood ereates a temporary fvid seal that would pool in that space and provide a pressure buffer agsinst the leakage indueing forces tht accompany systolic and diastolic related inr-atrial and intra-venriular pressure [0107] FIG. 25s a perspective view ofthe A3-PS side 783 ‘of prosthetic heart valve 700 according to an embodiment. FIG. 28 shows one of the three U-shaped wine components of inner frame 780 joined at their opened ends to form junctions 702. Leafleis 770 are sewn to these components Torm articulating leaflets 770 creating and Tunetioning a8 a prosthetic tricuspid valve. Atrial halo 758 is shown with the plane ofthe circle wiee above the plane ofthe majority of collar except for the vertical A2 segment 747, the P2 ‘segment 749, and the commissural AI-P] segment 751 and AS-P3 segment 783. FIG. 28 showes how upon deployment blood would fil the oid or gap 708 between the inner frame 70 and ostr frmme 720 atthe AX-P3 segment 753 area of the valve 700. This blod eretes a temyparaey Tid seal thatUS 2018/0271651 Al would pool in that space and provide pressure bute ‘gst he leakage indcing lores hat accompany systolic fd diastolic related intra-sealand inte-venticdae pees {0108}, FIG. 26 isan explode view of prosthetic heat ‘alve 700 acon oan embodisent ats valve 700 the Jer frame 780 i sewn with tse 76 and gets a cover to prevent valvular leakage, The inner frame 750 contains the Tealets 770 comprised of articulating leaflets that define & ‘alse fonetin. The leaflets 790 are sews to the inner frame 750. The inner frame 750 also has tether attachment sper {ures 7H for attaching tether assembly 790. Tether assem iy 790 is shown inthis example as connected epicarial securing pad 754, In eperatin, the covered ier frame 750 (Cg. covered with outer covering 760) (with leafless 770), $s dijposed within and secured within the outer fame 720 of tho otter frame eesembly 710. Outer frame 720 may also have in various embodinints a covering (eg. outer cover ing 730) Outer fame 720 his an arvculatiog collar 746 Which has collar cover 748. Artctlating collar 746 may baka have in some embodiments a D-shaped section 762 to ‘aecommodite and. solve left ventricular outow tract (VO obstuction issues [0109] In operation, the valve 700 may be deployed as a prosthetic vahe (emia valve) using cahetr delivery tecinigues. The eatve valve 700s compressed within & taro cater and delivered tothe annular region ofthe native valve, such as, for example, with pre-atached tether sembly 790. There, the valve 700 is pushed out ofthe ‘atete whore it springs open ino its pre-formed funetional shape without the ned for manval expansion (eg. mal ‘expansion using an inner balloon catheter). When the valve 00 is pushed andor pulled into place, the outer frame assembly 710is seated inthe native mial annulus, leaving the aniculaing collar 746 to engage the ata floor and prevent pull-through (where the valve is pulled ito the Neate). In such embodimens, itis not necessary 10 ceuaway’ the native Teafts, a8 as een taht in prior prosthetic efforts Insted, the ative leaflets can be used 10 Provide a teasioning andor scaling fanction around the ‘ler frame assembly 710, Its advantageous for te valve 700 to be asymmetrically deployed in order to adlress LVOT problems where aonaccomniodating peosbotic valves push against the A2 anterior segment of the valve (Gg, tte mira valve) and close blood How though the aorta, which anatomically sits immitly bein the A2 scament ofthe mitral annuus. Ths, D-shiped section 762 Jr deployed immediately adjacenicontcting the A2 sexe ment singe the Matened D-shaped section 762s stevcturlly tonaller and his amore vertical profile (closer to paralleling the longitudinal axis ofthe outer stent) and thereby provides Jess pressure on the A2 segment Once the ‘alve 700 is properly sate, tether assembly 790 may be extended out through the apical region of the left ventricle and secured using an epicarial pd 754 or sila sutreTockng atach- sent mcchanis, [0110] Any of the proshotic hart valve embodiments ‘eseribed above can ineorporte odiionl suovtra fax tures to eahance thir performance. ‘The stetra features ‘ze discussed belaw with reference o prosthetic heart valve 800, ilsirated schematically in perspective an side views in FIGS. 27 and 28, respectively. {O1IN| As shown, the outer fame 820 has an atrom potion 826, Ventre portion 822, and an annulus porto Sep. 27, 2018 824 disposed between the atrium portion 826 and the ventricle portion $22. The inner frame 980 ofthe inner valve assembly $40 bas a fist end and a second end. The inner valve assembly 840 can be coupled to the outer frame 820 bya connection between te fist endl ofthe inner frame 850 andthe ventricle portion 812 of the outer frame assembly 810. The inner frame assembly 840 can extend from the connection towards the atrium portion 816 of the outer ‘tame assembly 810. The inner frame assembly 840 and the cuter frame assembly 810 can diverge Irom the connection towards the atrium portion 816 ofthe outer frame assembly 810. The anaulus portion 814 of the outer frame assembly S810 can be spaced radialy from the inner valve assembly 840 und radially inwardly deflectable towards the inner valve assembly 840 to accommodate a natural ear valve ‘annulus in the annulus portion 814, [0112] The outer frame assembly 810 caa be shaped and sized in any stitable manner to facilitate « proper fit into @ native heat valve. For example, as shown, the outer frame 820 can he shaped and sized to resemble, atleast in part an hourglass shape. Specifically, the annulus portion 814 of ‘ter frame assembly 810 varies from an intermediste ameter (or perimeter) near ventiele portion 812 to a smaller diameter (or perimeter) near the middlle of annulus portion 814, to lager diameter (oF perimeter) near sina portion 816, Thus, annulus portion 814 has an hourglass shape: Ventrcle potion 812 has a maximum diameter lazer than a maximum diameter of annulus portion 816, The ventricle portion has minimum diameter smaller than a ‘nininnum diameter of the annulus portion B14. [0113] |The diameters and/or perimeters for each portion of the outer frame 820 can be selected based onthe size andlor shape of a native heart valve into which prosthetic heart valve 800 is to he implanted. For example, the minisaim ameter of the annolus portion 824 ofthe outer fame 820 fan he smaller than that ofthe native valve annulus. Thus, insueh a configuration, te diameters of the ventricle portion 822, annulus portion 824, and atrium portion 826 can collectively promote a suitable fit (e.g. a snug, secure fi) of the prosthetic heart valve 800 in a native heart valve. I his ‘manner, the outer fame 820 can be configured to aptimize securement and sealing between the prosthetic heart valve £800 (particularly outer frame assembly B10) and a native valve annulis of a native heat valve, Thus, such a configu ‘ation minimizes the likelihood of paravalvular leaks. [0114] Although the outer frame 820 is shown to have circular cross-section, in. some embodiments, the outer fame 820 can by any suitable shape or size. For example, in some embodiments, the outer frame 820 can have Deshape crostscction. ln this manner, the outer frame 820 can lave a shape configured to comespond 10 (eg., mate \with) a native heart valve annulus. 0115] _In ition, or instead of, outer frame 820 andlor ‘outer fame assembly 810 with the hourglass shape eseribed shove, valve 800, oF in some instances, outer Tame 820 and/or outer frame assembly 810, in parculee, can be formed to provide stifiness, such as resistance to hoop compression, that is varied spatially, ie, axially andlor circumferential [0116] In this manner, a suitable stifness profile can be fnranged stich that the valve 800 promotes a desirable shape ‘nd sealing region when disposed in a native heat valve. thus minimizing the likelihood of paravalvolar leaks and ‘undesired movement of the valve, Similarly stated, valveUS 2018/0271651 Al 800 can be configured to havea siness profile suitable t0 ‘cause desirable deformation of the native heat valve anu Jus i. the sealing repion), and thus, proper implantation of valve 800. [0117] A desired stitfaess profile of prosthetic valve 800 ‘can be achieved by varying properties, characteristics, and ‘or the arrangement of the outer frame assembly 810 and the nner valve assembly 840. For example, the outer frame 820 ‘and/or the inner frame 880 ean coatsin portions of varying material states. For example, a first portion of oer frame £820 can be in anclaste state, while a second portion of outer frame 820 is in a superclastic state. Similarly, for example, portions of the outer frame 820 andor the inner frame 850 ‘can he in an austenitic state andior a martensitic sate (©. a sress induced martensite state). In ‘of valve 800 can be configured to suitably ‘native valve annuus, thus improving sealing and limiting paraval- var leas. [0118] In addition, the outer fame assembly 810 andlor inner valve assembly 840 can have varying widths, thick- nesses, shapes (e, longitudinal shape), angles (ez. angle ‘of attachment between inner valve assembly 840 and outer Jame assembly 810). and the like. In some embodiments the outer covering 830, inner covering 832, outer covering 860, andor pocket closure 880 can be configured to deter mine, at least in par, the stiffsess profile andlor shape of valve 800 (e.g, based on sewing patter). [0119] FIGS. 298, and 29C and 29D illustrate axial and unferential stillness profiles, respectively, of prosthetic hear valve 800 (shown in FIG. 29A) according to an ‘embodiment. The stfiness of heart valve 800 can sary axially and/or circumferentially in any suitable manner. For ‘example, FIG, 298 represents an axial stillness profile of valve 800. Specially, as shown, the Z-axis represents an axial location on valve 800 (eg. a location of the stifiness valus). The S-axis represents. range of sifiness (or range of stlfoess values), increasing from lft (starting a origin O)t0 Fight 10120) Further co this example, as ilustated in FIG. 298, in some embodiments, locations near the ventricle portion £822 (eg, indicated as B in FIG, 294) of the outer feame 822, ‘can have a larger sifiaess vale, locations near the annulus portion 824 of the outer frame 820 can have a smaller silflacrs value relative tothe ventricle portion #22 (e,.10 facilitate cooperation with the native valve annulus), and locations near the atrium portion 826 (eg. indicated as A in FIG. 29) of the outer frame 820 can have a smaller, the same, or larger silliness value (llustated by’ the dotted line) than the stiffness value near the annulus portion 824. Tn this ‘manner, the outer frame assembly 810 canbe relatively more ‘compliant in hoop compression in central, annulus portion 814, than at the ventricle portion 812. Thus, in use, the prosthetic valve 800 can seat securely in the annulus of the native heart valve while imposing minimal loads on the inner valve assembly 840 that could degrade the perfor mance of the valve Jeallets 870. Although, for ease of ithastation, the stfiness profile shown in FIG. 298 includes finear portions, in some embodiments, the silhest profile ‘can include non-linear portions instead of or in addition to the linear portions as show 10121} Similarly, the stiffness of heart valve 800, or por tions of heart valve 800, can have varying degrees of stilfess circumferentally. as illistrated by the stillness profiles show 29C and 29 D. By way of example, Sep. 27, 2018 5, 29C illustrates a circumferential stilfiaess profile at axial location A (as shown by reference "A’ in FIG. 294). Similarly, FIG. 29D illustrates a circumferential stiffuess profle a axial location B (as shown by reference “Bin FIG. 29), As the profile extends radially fom the origin (indi- cated as “O°, the stillness val increases. 0122} ‘Thus, s shown in FIG. 29C, the sifiness at SI (20 degrees) is greater than the silflnss at S2 (270 degrees). Funker o this example, in some embodiments the circum- erential portion from zero to 180 degrees ean represent 9 relatively Nat portion of an outer frame 820 of the outer fame assembly 810 having a D-shape configuration, and 180 fo 360 degrees can representa relatively curved portion of the outer fr 820 having the Dshape configuration, lar fashion, FIG, 29D illustrates a circum ss profile at awial location B (as shown by reerence ‘Bin FIG. 294). As shown, axial location B has a different stilfness profile than axial locaton A. Such variability in design, as discussed above, can provide for advantageous customization of heart valve 800, and coop: tration of heart valve 800 witha native heart valve. Similar tO FIG. 29C, FIG, 29D ilusteates the stiffaess atone side of valve 800 being greater than a stiffness at another side ofthe valve 800. In this manner, in some instances, a portion of valve 800 that will experience greater forces from the native hart valve annulus can have a smaller stiffness value (eg sore compliant) than @ portion of the valve 800 that wil experience smaller or fewer forces, ths. optimizing. the ‘cooperation ofthe prosthetic heart valve 800 with the native heart (panicularlythe native heaet valve annular region), [0124] As discussed above, in some instances,» patient having an implanted prosthetic heart valve may experience postoneraive LVOT obsirietions resulting from, Tor ample, subvaivular positioning or configuration of the prosthetic heart valve. Described below and iluststed in FIGS, 30-351 are various embodiments of prostelic heat valves, ia expanded or deployed configurations, that are configured to avoid, reduce of otherwise limit undesirable IVOT obstrction. To assist in the understanding of the relationship between the various prosthetic valve embod iments and the anatomy of a heart, FIGS. 38 and 38B illustrate in a patil cross-sectional side view and top view. respectfully an exemplary prosthetic heart mitral valve 1400 (also referred to herein as “walve") implanted in a native ial annulus ofa heart. The prosthetic heart mital valve 1400 can be constructed and function similar to any of the prosthetic heart valves described herein, For exanple the Valve 1400 can include an outer frame 1420 and aa inner ‘ame 1480, Thus, some details regarding the valve 1400 are sot described below. Tt should be understood that for fea- tures and functions not specifically discussed, those features and functions can be the samme as oF similar to any of the valves described herein [0125] As shown in FIGS. 388 and 38D, the prosthetic heart mitral valve 1400 (also refered to herein as “valve”) in its expanded or deployed configuration is seated in the ‘ative mitral valve annulus NA between the let ventricle LV ‘and the left aium LA of the heart H. la operation, the left ventricle LV’ contracts and blood flows outwardly from the Jeft ventricle LV through the aortie valve AV via the Tet ventricular outflow tract (LVOT). The path of such blood flow is shown in FIG. 38A by arrow LVOT. When the prosthetic heart valve 1400 is deployed! and seated in the ‘ative mitral valve annulus NA, a shown, the A2 sewiesUS 2018/0271651 Al 1447 of the outer frame 1420 of he valve 1400 (ie. the anterior side ofthe valve 1400) is aligned with or seated at the A2 anterior seument (labeled A2 in FIGS, 38, and 38B) ‘of the native mitgal valve annulus. Furher, as shown, whea, the valve 1400 is deployed and seated in the native mital valve annulus NA, the P2 segment 1449 of the outer frame 1420 of the valve 1400 (i.e, the postecor sido of the valve 1400) i aligned with or seated at the P2 posterior segment (labeled P2 in FIGS. 354 and 38B) ofthe native mitral valve annals 10126] As shown in FIG. 3A, during operation of the heart, the native leaflet NLI on the aaterior side (native Jeaflet NL2 is on the posterior side) can intrude into the LVOT, identified by the change in position of the native anterior leaflet NLI from a fist position shown in sotid-tine to a second position shown ia dashed-ine in which the Jeaflet NL intrades into of obstructs the LVOT. 10127] In one embodiment, an outer frame ofa prosthetic heart valve can be configured similar to the outer frames described above (e.g, the outer frame 520) except thatthe ‘culf portion is disposed at an angle (eg, less than, 90 ‘degrees relative tothe vertical axis ofa body portion ofthe fuer frame (also referred to herein as the “angled cull arrangement” discussed in more detail below with reference to FIGS. 304-300). In this manner, in use, a prosthetic heart valve ean be delivered and deployed to & native heart (ie sete inthe native annul of the bear) such that at Teast @ portion of the prosthetic heart valve disposed in the ventricle ‘of the heat is oriented or positioned away Irom the LVOT of the heart. As such, the angled cuff arrangement ean, prevent, reduce or otherwise limit [VOT obstruction (or ‘ntesion by the native leaflet). Similarly stated, the angled ‘cuff arrangement can provide additional LVOT clearan As discussed above, an implanted prosthetic valve, or 3 portion thereof, can contribute to the postoperative compli- feation of [VOT obstruction. An angled cuff arrangement, however, can limit or prevent LVOT obsirution by limiting the placement of the prosthetic valve in the [VOT of the hear. [0128] FIG. 304 ilostrates an outer frame 920 ofa pros- thetic heart valve 900 having an angled cuff arrangement, and FIG. 30B illustrates @ schematic side erose-sectional View ofthe prosthetic heart valve 900 shown in FIG. 30A, including a inner valve assembly 940, The prosthetic hear valve 900 (also refered to herein as “valve") can be structed and function similar to any of the prosthetic heart valves described herein, ex, the prosthede heart valve $00. ‘Thus, some details regarding the valve 900 are no described below, 1t should be understood that for features and fune- tions not specifically discussed, those features and funetions ‘canbe the same as or similar to any of the valves described herein [0129] As shown in FIG. 30A, the outer frame 920 includes a coupling portion 974, a body portion 972, and a ‘culf portion 973. Whea the valve 900 is disposed within 2 native mitral annulus of a hear, the cuff portion 973 is ‘configured to be seated within the native mitral anoulus and ‘extend within the atrium of the heat and the body portion ‘972 is configured to be disposed within a ventricle of the hear. The coupling portion 971 is configured to be coupled to the inner valve assembly. In this embodiment, the cull portion 973 is disposed at an angle c relative to the vertical xis A. Said another way. as shown in FIG. 304, the cull portion 973 slopes downward from the anterior side of the Sep. 27, 2018 valve 900 to the posterior side of the valve 900. Io this ‘manner, when the prosttic heart valve 900 is implanted into a heart (e.g, when the cull porion 973 is seated in the ‘ative annulus ofthe heart), de angle ofthe eull portion 973 ‘will eauso the body portion 972 of the valve 900 to be briented or positioned away fom the [VOT of the hear, thereby preventing, nxhucing or otherwise limiting undesir able [VOT obstriction. [0130] An angle «defined by the eulf portion 973 andthe vertical axis.Aof the prosthetic valve 900 can be any stable value configured to create, increase or otherwise promote LVOT clearance and limit or prevent LVOT obstnicton (or undesirable outflow gradients). The angle « can be, for ccxample, an acute angle. As shown in FIG. 30, the angle is about 80 degrees. In other embodiments, however, the angle cecan be for example, from about 70 degrees to about less than 90 degrees, As the LVOT varies across patients, eg, depending on a patient's parcular anatomy, the angle can be adjusted accordingly: [0131] As shown in FIG. 308, the body portion 972 of the ‘outer Frame 920 has varying lengths dve to the angled cuit arrangement. More panicularly, an anterior portion of the body portion 972 hat ua anterior length Lal, anda posterior portin has a relatively smaller posterior length pt. The anterior length Lat an the posterior length Lp can be any stale value configured to create, increase of otherwise promote LVOT clearance snd limit LVOT obstruction oF ‘undesirable outflow gradients. In some instances, [or ‘example, the anterior length Lat ean be about 18 mm and the posterior length Lp! ean be about 14 mm. As the LVOT varies across patients, eg.. depending on a patients par ticular anatomy, the anterior length Lat and the posterior [pf can be adjusted accondingly [0132] Further. as shown in FIG. 30B, an atrial end portion 985 ofthe inner valve assembly 940 extends a legth of Lil from the location at which the inner valve assembly 940 is ccupled to the outer frame 920 whea the inner valve fssemtbly 940 is seated in the outer frame 920, Also shown in PIG. 30B, in some embodiments, the inner valve assem- bly 940 (eg, the inner fame 980 shown in FIG. 30C) ean hhave a centerline substantially parallel to the ceaterine of the outer frame 920. FIG. 30€ shows aside view ofthe prosthetic heart valve 900 (with the angled cuff arrangement), in a deployed or biased configuration, and for comparison, a sie view of ‘prosthetic heart valve 900' without the angled cull arange- ‘meat, Both the valve 900 and the valve 900” ate shown similar to how each Valve would be arranged when seated ‘within a native annulus of a heart (not shown). The valve 900, for example, can be constricted and function similar t0 ‘or the same as the prosthetic heart valve $00, [0134] As discussed with respect to FIGS. 38 and 388, ‘noperation, the left ventricle of the heart (not shown in FIG. 30C) contracts and blood laws outwardly from the left ventricle through the aortic valve via the LVOT. The path of seh blood flow is shown in FIG, 30C by aerow LVOT. As shown, the outer frame 920 of the valve 900 provides ‘addtional LVOT clearance when compared 10 the outer frame 920’ ofthe valve 9007 Por example, as shown in FIG. 30C, the strut 954 of the inner feame 950 of the valve 900 js disposed a greater distance from and provides greater clearance to the LVOT. As shown by comparison to the valve 9007, the strut 984 of the inner fame 980 of valve 900 is displaced from the sirut 984 of the ier frame 980" of