2) United States Patent oy oy 3) en @ 6s) @ on} Moser et al. PROSTHETIC ANKLE JOINT MECHANISM Applicant: Blatchford Products Hampshire (GB) ited, Inventors: David Moser, Hampshire (G3); Fadt Abimosleh, Springboro, OH! (US); Mir Saeed Zahedi, London (GB); Graham Harris, Hampshire (GB): Stephen Terry Lang, Hampshire (GB); Andrew John Sykes, Surey (GB) Assignee: Blatchford Products Limited Hampshire (GB) Notice: Subject to any disclaimer, the team ofthis, patent is extended or adjusted under 35 USC. 1540) by 0 days. Appl. No. 16/010,829 Filed: mn 18, 2018 ‘ior Publication Data US 201910021882 Al Jan, 24, 2019 Related U.S. Application Data Continuation of application No, 15/227,5145 filed on Aug. 3, 2016, now Pat, No. 9,999,526, which is 3 (Continved) Im. C1, AGIF 2166 (2006.01) GIF 2468 (2006.01) (Continue ABLE 25607 (2013.01); ABIE 2/74 (2021.08), 461F 2/748 (2021.08); (Continued) US 11,679,008 B2 Jun, 20, 2023 0 'USO11679008B2 (10) Patent No.: (4s) Date of Patent: Field of Classification Search cP AGILE 216607 See application file for complete search history. 68) 66) References Cited US. PATENT DOCUMENTS. mest 2amas A 21863. Paametoe S108 Foss (Continved) FOREIGN PATENT DOCUMENTS ew orsisa73 972000 (Continved) OTHER PUBLICATIONS Olice Acton for US. Arp. No. 157227,514 dated Nov. 9, 2017 (Continved) Primary Esaminer —Iooqueine Wornick’ (74) Attorney, Agent, or Firm — Alston & Bird LLP on ABSTRACT A self-ligning prosthetic foot and ankle assembly bas an Ankle unit pivotally mounting foot component. The ankle unit contains a hydraulic piston and eylinder assembly having piston which s linearly movable within a eylinder The axis of the cylinder is coineident witha shin axis defined bby a shin connection interface on the ankle unit. Bypass passages containing damping resistance control valves pro- Vide continuous hydraulic damping of dorsi and plantar ankle Nexon, the unit being such that, over the major part of ‘of damped movement, there is no resilient biasing in either the dorsi or the plantar direction. This confers a umber of advantage. including stabilisation of standing. balanee contr, and improves! stairwalking and ramp: 19 Ch + § Drawing SheetsUS 11,679,008 B2 age 2 Related US. Application Data no4eAt95 AL* 42008 tae A61F 26 4 wae continuation of application No. 14051775, filed on a0o4urs6a35 a1 112001 Chen ‘Oct 1, 203, now Pat No, 943.513, wich isa SODSISIST AL "YAM Dio xminiton of applicton No. 11386391 fled on amwoum AF Siuoy Wine sb De. 14 2007, ns Dat No. 8574.13. ousois2cr? AL 92005 Rags Zoom At "3200" Saat (60), Pasion application No, 686.959, fon Dee. osonta» Al_ 13008 hb I er Sovcocyeest At 103000 here otk 261 a338 oosorenis at 11206 GH) mcr woes 8 AGIE 374 «2006.01) Boyar At 2007 Noga ot ‘e1P 230 Govso1) Zeosnnenis al Nester air v0 {2000}, ooeuneeas At Mow ta. ‘air 70 Gonso1) dunssise & ‘os to (2) USL oeraeer al cr 4AGIF 200230339 201301) 461 nsatisso AL Soo2'so0s Q013.01) 161F 20005006 rpois Al cenrsiny are Son2sn3s Corson, dere Btemvets AL 200245083 20181), 461F 2oonee21 — MNAOOETOR AL Mos 2013.01), 461 200216682 Corson, a6ir ETSI A aes (2013.01), 66) USS. PATENT DOCUMENTS. x a S 3sonan & ‘Sonig29 AosLsss A S2i2087 & Sinsoa9 A Sas3e0 A siieast A Saason9 A 5458656 4 SpInoOr A Spstost A a a 6033440 6080197 arses? 6as02 BL Fssaa TNK Tossa6s 246.595 Siisors 2002068%863 son2008712 aon20120849| 20020138153 2ongo44s7 aoouoos4as 2002/6657 (2013.01); A61F 2002/6854 S61F 200/705 (201301), ABLE 202/707 (2013.01); A6IF 22200033 References Cited io divs 1953 ss 988 i938 Sin Bits 31977 ois? 1980 Tiss S091 S992 i005 10.1995 1099 S999 32000 62000 52000 22001 2002 S002 2003 200s ios 33000 112009 2201 F201 012 9201s S002 62002 $2002 9002 ‘004 $2008 Getinan ta stn aller Comal March alent Glaieroesk Kame nit ta Xileion Mortensen Shove. has Schall hen Pamiky Molin et Helberg al Kenia Zao Davos al Christensen ‘Townsend et al Bourne ea: a Moser Monte Moser et ler ‘Townsend ot al Philips Keo Geass Martin 201301) ALF 26607 ‘oyar ASIF 275 “ones ASIF 268 1982823 ASIF 26607 ova ASIF 26607 ayas FOREIGN PATENT DOCUMENTS DE a1ormr al gis O's49 885 BL S)1996 iP oak 47 Ar 101999 iP Tose 44 AL ‘12001 ran HT 91980 Gb. 2mav7T A 21981 ce. diosa’ Giioor ce Ueto A 210 ” c ros @ » 2001-51425 A @ 004:s06460 9 @ oos-sseo18 A ® oons1s608 A Wo woos060s Al WO WO 9625408 Al WO WO D900075 AL WO WO 0076429 Al WO WO0218H6 AL WO WO OSORE2AS AZ WO WO 2006112774 AL WO Wo 2007027808 AZ WO Wo 2007084736 AP WO Wo 2008071995 AL wo YO SostaIwTE AP WO — WoRWNINBIT AL $2008 WO WORIDIOIE AL £2012 (OTHER PUBLICATIONS "Extend European Search Report for European Applicaton No. 18 17401 data Nov. 29.2018 6 pages, Notice of Allowance for U.S. App. No. 15 2018 Notice of Allowance US. App. No, 19227.5H4 dated Feb. 21 201s “Anatomic and Biomechanical Characteristics ofthe Ankle Joint and Tol Ankle Arthroplasty Total Ankle Arthroplasty Dee. 5, 2005, Springer Vienna, ISBN 978-3-211-21252 (pat) 978-3211. 27254-1 (online), pp. 25-42. EndaliteGlobel”Eehlon VT Foot Prssriptio online Itreved May 7. 2012] Resoved from the Inteet- URL: hp: ww, ‘uli oases fet echelon_wecelon xt fot m= Tope Furman. Bes, rogressin Prostheses, U.S: Deparmet of Heath, Education, and Weltre; 1064 Haves, W-C ta Leg Motion Anlsix Daring Gat by Mull Acceleronetr Theoretical Foundations and Preliminary Fai tion, Jounal of Biomechanical Engineering, vl. 108 (1983) 283. 28 14 dated. 6US 11,679,008 B2 Page 3 66) References Cited (OTHER PUBLICATIONS, Hydrulik Ankle Unit Manual; Mauch Laboratories, In. Mar Oss “Michal J etal ;“Iip Disaticulation and Teanspeltic Amputation: Prosthtic Managements Als of Limb Prosthetic: Sura, Pros ‘het, and Rehabilitation Principles, 2d edn, Ch. 208, 1992, “Moms, W. "Acclerometty A Technique forthe Measurement of Haman Body Movements", Joural of Biomechanics (1973) 26.736 Murpiy, Eugene Fs “The Swing of Watking with Above-Knece Prostheses” alin of Prosthetics Research, Veterans Administra: ion Sping 1964, Roylanes Davi “Engineering Vscelasicity" Department of Mae nals Science and Engineering, Masschusts Institute of Technol gy Ost 24.2001, Seal. e¢ als “Kinematic Comparisons of Transfemoral Amputee (Gai Using C-Leg and Mauch SNS Prosbtic Kaces:" The Toure ‘of Rehabilitation Reseach and Development, vl 3, No.7: pp 857-870; dated Nov. Dee. 2006; Figure. Sowell 7. "A peeliniaay clinical evaluation of the Mauch hydraulic Tootankle system’ Prosthetics and. Orthos Interna tional ok $, pp 8729, 1987. Starker Flix ct al; “Remaking the Mach Hydolic Ankle” Capaities, vol 18 No.1, Winer 2010; Nonhwestem University International Serch Report and Writen Opinion for International Applicaton No. PCT'GB2007 004785, dated Apr. 29,2008 Interationl Search Report and Written Opinion for atrnational ‘pplication No, PCTUS20081S474 date Tul. 2, 2008, ‘Otice Action for US. Appl. No. 12038717: dated Aug 5, 2009, ‘ice Action for US. Appl No. 11986:39: dated Sep. 18,2008, ‘Ofice Action for US. Appl No. 120035717 dated Ape 21,2010, ‘Ofce Action for US. Appl No. 11956.391; dated Jun. 18,2010, (Olle Action for US. App No. 1986391, dated May 10,2011 Seateh Report for Grea Briain Application No. HOIS®3.4 dated May 11,2011 ‘Combine Search and Examination Report for Great Britain Appli- ‘aon No, GBI2OUS750 dated Ap, 12,2012, Intemational Search Report ad Written Opinion for latrntinal Application No, PCT'GH2012000119, dated Ape 24, 2012 ‘Oflce Action for US. Appl No. 1195639K; ded ol 5,201 ‘Oice Acton for Japanese Application No, 2000-5S1033 dated Oice Action for US. Appl No. 13150694, dated Dee. 4, 2012 Otic Acton for US. App. No. 15'364,786, dated May 2, 2013, Otic Action for tS. Appl No. 13/150,693, dite Ju. 19,2013, Oce Action for US. App No. 11986,39K dates. ul. 30, 2013 Otc Acton for US. Appl No. 1986191; dated Sep. 16, 2013 Ole Acton for US. Appl No. 13150604, dated Dee 30,2013. Oc Acton fr US. App. No. [4073.34 dtd Jan 2, 2014 Otic Action fr European Application No, 7 8485273 dated Feb, 25, 2014, 6 pages. Otice Action for Earopesn Application No. 08 730 S314 dated ‘Mar. 21, 20,4 page. Otice Action for U'S. Appl No. 13150604, dated Nay 9, 2014 Otic Acton fr US. App. No. 14081778 dated Now 25,2014 Otc Acton for US. Appl No, 13150694, dated Dee. 17,2014 Oe Action for US. AgpL No. 14,051,775 date Jan. 12. 2015, Devision,IPR2O15.00640, US, Pat, No. 8740:991 B2, dated Jl 31, 2015, 29 pases. Desision,IPR201S.00641, U.S. Pat No. 8578;312 Bi date Ju 31,2015, 29 pages Decision IPROOIS.00612, US. Pat, No. 574.312 B2, dated Jl 31,2015, 25 pages. Otic Action for European Application No, 08730 $314 dated Jun, 17, 2016, 3 pages Otice Action for Furopean Applicaton No, 08 7305314 dated Feb, 27,2017 Otce Action for US. Appl No 18/227,814 dtl Ape: 26,2017, 28 pages ‘Winter, David A: Kinematics 13.2 and Kinatis 1.33; Biomochan- Jes and Motor Contol of Human Movement, Fourth Fito; 2009; 3 pases Oc Acton for US. Appl. No. 1482.64, dated May 30,2017 30 pages. Oc Acton fr US. Appl. No. 142,645 date Fay. 2018 tended European Sesh Ropor for EP No. 201575077 dated Sep 4, 2020 (6 pags Interatinal Primary Report on Paletbliy resciv for PCT Fen Apyaion No BCT US2008 Dra dats Aus 2,200, Trees ‘Wigner, Edmond M; “Contos ofthe Lows Extremity Pos thes Pou’, 1 Arca Limbs 8; Nana Asay of Se coces Nation Reseach Counc May 1934 * cited by examinerU.S. Patent Jun, 20, 2023 Sheet 1 of 5 US 11,679,008 B2 a 8 2 8 2 © oe ae ola (8 R888 [8 g 8 s 4 8 24K 14 FIG. 1 128U.S. Patent Jun, 20, 2023 Sheet 2 of 5 US 11,679,008 B2 FIG. 2U.S. Patent Jun, 20, 2023 Sheet 3 of 5 US 11,679,008 B2 “WS Or~L sea 388+U.S. Patent Jun, 20, 2023 Sheet 4 of 5 US 11,679,008 B2 26A 268 FIG. 4U.S. Patent Jun, 20, 2023 Sheet 5 of 5 US 11,679,008 B2 (@) (b) ©) @ ) FIG. 6US 11,679,008 B2 1 PROSTHETIC ANKLE JOINT MECHANISM. CROSS-REFERENCE TO RELATED APPLICATION ‘he present application is @ continuation of US. patent ‘application Ser. No, 15/227,514, fled Aug. 3, 2016, which, Js. continuation of U:S. patent application Se. No. 14/051, 715, fled Oct. 11, 2013, which is a continuation of US: patent application Ser. No. 11/956,391, filed Dee. 14, 2007, Which elaims the heneft of US. Provisional Patent Applic «ation No. 60/869, 959, filed Dec. 14, 2005, each of which is hereby incorporated by reference in its entirety BACKGROUND OF THE INVENTION This invention relates to a prosibetie ankle joint mecha nism, toa lower limb prosthesis comprising a shin compo- nent, # foot component, and a joint mechanism intecon- necting the shin and foot components, and to a prosthetic oot and ankle assembly. The joint mechanism is atranged 0 allow limited damped pivoting movemeat ofthe shin com- Pnent relative to the foot component Current prosthetic foot and ankle systems are generally aligned for operation as fixed mechanical structures com prising elastic and deformable elements designed wo provide Stability during standing and walking and to retun encray Jor propulsion into the swing phase of the walking eyele. However, such device is often uncomfortable forthe user ‘whilst standing and whilst walking on ramps and staies and ‘walking at different specs. Users have also experienced knee instability and difficulty in maintaining forward mation during roll-over ofthe foot while standing and walking on amps and stair, with consequent impaintient of elicieney, ‘These dificulties ae particularly important for transfemoral amputees whose stance phase action is normally compro= mised by significantly reduced knee flexion and extension ‘which would otherwise assist shock absorption and forwards propulsion during the stance phase ‘An ankle joint mechanism allowing dynamic hydaulic ‘control of the angular postion of a prosthetic foot with respect toa shin component is disclosed in Mauch Labora- tories, Inc, Hydraulit Ankle Unit Manual, March 1988. The shin component is alached to a vane piston housed in ‘lui fle chamber with « concave part-cieulr lower wal. A\ gravity-contrlled ball rolls forwards and backwards on the wall aecoring to the orientation ofthe foot to open or ‘lose a bypass passage in the piston. AS a result, dors Alexion of the mechanism is prevented when the shin com- ponent is vertical, langely iespective of whether the oot is horiontal or inclined downwardly or upwanily. Sueb a prosthesis also. sullers partly from the disadvantages {eseribed above, "Amongst other known prosthetic ankle systems is that of US. Pat. No. 3871,032 (Karas). This system eontains ‘damping device having a dual piston and eylinder assembly with tappet retum springs acting continuously to retum the ankle to a neutral position. EP-A-0948047 (O'Byrne) dis- ‘loses prosthetic ankle having a ball-and-socket joint with a chamber filled with a silicon-based hydraulic substance, the joint having a viseo-elastie response. In one embod ment, the chamber contains solid silicone rubber particles suspended ina silicone uid. matrix, US2008I0236435 (Chen) diselososa hydraulic ankle arangement with ajst- able hydraulic damping and resilient bissing members ‘mounted anteriorly and posteriorly of an ankle joint rotation ais. In WO00/76429 (Gramiee), a lez prosthesis is 0 o 2 described having an ankle joint allowing heel eight adjust meat by way of a hydraulic piston and linkage arrangement Elastic components absorb shock during walking. US206/ (0285544 (Iversen tal) discloses a hydraulic ankle mecha- nism witha rotary vane BRIEP_ SUMMARY OF THE INVENTION According toa fst aspect ofthis invention, a prostheti ankle joint mectanism provides a continuously hydraul cally damped range of ankle flexion, the mechanism being constructed and arranged suc that, over at least part of sad range, te damping resistance is dhe predominant resistance to flexion. The mechanism preferably comprises « hydraulic Jineae piston and eylinder assembly. The piston may have distal connection means For pivotal connection 10 2 foot ‘component, the eylinder having proximal connection means or connection a shin component. Typically the piston and cylinder assembly has a central axis Which i oriented sueh that when the mechanism is eoupled to a prosthetic shin component, the central axis is substantially aligned with or parallel to a shin axis defined by the shin component ‘To allow individaal setting of dorsi and plantar-flexion| damping, resistances, the mechanism may have a valve ‘arrangement controlling the flow of hydraulic Mid between ‘hanibers ofthe piston and eylinder on opposite sides ofthe piston, the valve arrangement preferably comprising first fad second adjustable valves for dorsiflexion and plantar Alexion damping control respectively, “According to another aspect of the invention, a prosthetic ankle joint mechanism provides a continuously hydraul cally damped range of ankle flexion, the mechanism being ‘onsiucted and atraged such that, over at least part of the rnge, movement in the dorsi and plantar directions is substantially unbiased resiliently. ‘The invention also inchides a prostheti foot and ankle assembly comprising the combination ofa foot component and, mounted to the foot component, an ankle joint mecha- ‘ism having the features deseribel above, Its preferred that the ankle joint mechanism inckides flexion limiting means Timing dorsi lexion of the joint mechanism to a dori lexion limit, the shin connection interface being arranged to allow connection of shin component at different anterior posterior tilt angles, These angles include angles resulting in the shin component having an anterior tit of at least 3° with respect to the vertical when the joint mechanism is exed 10 the dorsi-flexion limit. The dorsiflexion limit advanta- eously corresponds (0 a predetermined orientation of the shin component interface relative tothe foot component and ray be defined by a mechanical end stop operative by the abutment of one part of the prosthetic foot and ankle assembly associated with the shin component interface ‘against another part of the assembly associated with the foot component. Conveniently, the end stop is defined by the Piston of the piston and eylinder assembly abuting an end ‘wall of the eylinder ‘In the preferred embodiment of the invention described Dereinaltes, the range of damped ankle Hexion is. xe Nevenless the above-mentioned dorsiflexion limit may be adjustable over atleast a range of anterior posterior tilt Angles from 3° to 6°, In another embodiment, the range of damped flexion may’ alter when the dorsiflexion limit is adjusted, bt once the adjustment bas been made, the range fof damped flexion is, kewise, fixed fom step 0 step. ‘The assembly may be arranged such that the relative position of the foot component and the shin connectionUS 11,679,008 B2 3 interface at the dorsiflexion limit is defined ‘of the orientation of the assembly in space, Adjustment of the shin axis orientation in the anterior. posterior direction with respect tothe foot component may be performed using atleast one conventional pyramid align- ‘ment interface, preferably the shin component interface The above-described prosthesis, in which the ankle allows, dorsi-plantar lexion over a limited range of movement with Jargely damped, as opposed to resilient, resistance to mation results in an ankle which is able easily to flex under load acconting (0 changing activity requirements without gen- ‘ration of high reaction moments which Would otherwise ‘cause discomfort and compromise the funetion of the pros- thesis. Providing damped and substantially unbiased move- ment means that the ankle thereby fnetions in away seh that it remains in its last Ioaded orieatation, having. no recalignment capability once the foot is unlosded. This eure is advantageous to assist foot clearance during the swing phase. ‘By arranging forthe posi foot component interface relative to the shin connection Jnerface at the dorsiflexion limit to be defined indepen- dently of the orientation of the assembly in space, and by using pravity-independent detemnination ofthe dosi-tlexion ndependently Jimit, the nood fora pravity-dependent valve systom with an > ‘end-stop corresponding 10 vertical orientation of the shi axis is avoided. The prosthesis described above allows set-up flexibility o alter the dynamies of roll-over tough selection of different te spring sifnesses. The range of ‘yielding. motion ean he altered by altering the relative Alignment of the foot and shin components. Allowing the shin axis to move to the anterior of the vertical position is particularly advantageous during stir and ramp walking ‘aetvities, ‘The conventional approach of maximising energy storage and return has produced designs in whiet the ankle has 2 high elastic stifness at all times. Reducing stiffness in the ‘manner proposed in accordance with the present invention _reatly improves comfort for the user as well as helping to preserve forwards momentum of the upper body ard thus focomotion efiiency. Reaction moments about the ankle ate largely dissipated withthe result that voluotary control tnd proprioception ofthe knee and hip in BK (helow-knce) amputees, in particular is improved. ‘According to a further aspect of the invention, there is provided a prosthetic foot and ankle assembly comprising the combination of an ankle joint mechanism as described above, together with a prosthetic energy-storing foot whieh js resiliently deformable to allow dorsiflexion of atleast an anterior portion of the foot relative to an ankle-mounting portion of the foot. ‘The invention also includes a lower limb prosthesis ‘comprising a shin component desing a shin axis, foot ‘component, and att ankle joint mechanism as described ‘above, the ankle joint mechanism coupling the shin com= ponent tothe foot component, wherein atleast one of the oot eomponent and the shin component includes resilient section allowing resilient dorsiflexion of atleast an anterior portion of the foot component relative t the shin axis. The oot component may comprise an energy-storing spring ‘rtanged 10 be deflected when a dorsiflexion load is applied to the foot anterior portion. Alternatively, the prosthesis may ‘include resilient section associated with the coupling ofthe oot component andthe ankle joint mechanism, allowing @ “degree of resilient dorsi-lexion. As another altemative, there ‘may bea resilient section associated with the coupling ofthe shin component o the aakle joint mechanism, 1 ofthe foot component or the o 4 Another aspect of the invention resides in prosthetic fot and ankle assembly comprising the combination of an ankle jpint mechanism and a prosthetic foot having an anterior Portion, a posterior portion and an ankle-mounting portion, ‘wherein the assembly constitutes a Maxwellamodel damper! spring combination of which the damper clement is said ankle joint mechanism and the spring element is a spring ‘component srraniged in series with the ankle joint, ‘Deseribed below isa ower limb prosthesis comprising 3 shin component defining a shin axis, afoot componeat, and joint mechanism intereonnecting the shin and foot com- poneals and arranged to allow limited damped pivoting of the shin component relative fo the foot component about a smedil-lateral joint Mlexion axis during use, wherein the ‘mechanism comprises: a piston and eylinder assembly the piston of which is movable so as define a variable-vol Auideflld chamber ofthe assembly, fui being admitted t0 ‘or expelled from the chamber through atleast one damping orifice as the relative orientation of the shin and foot ‘compotents varies with flexion ofthe joimt mecanisa: and Flexion limiting means limiting dorsi-lexion of the joint srechanism to 2 dorsiflexion limit comesponding to otien- tation of the shin component with the shin axis tilted anteriorly with respect to the vertical by at east 3 degrees. The joint mechanism is preferably arranged. such that damped relative pivoting of the shin component and te foot ‘component is allowed over an angular range between dorsi- ‘and plaatar-lexion limits, the dorsiflexion Timit. being adjustable to different anterior tilt settings of the shin axis ‘with respect tothe foot component. In paticular, the angular fringe encompasses 2 foot-at, shin-axis-vertial state with the permitted degree of shin axis tit being adjustable t0 ferent values to the anterior of the vertical the preferred embodiment of the invention, the joi seca has a fst part associted with the shin compo- ‘ent and a second pat associated with the foot component, these two pars being pivotally interconnected with the ‘connection defining a joint flexion axis. One of the ro parts Jncludes the chamber of the piston and eylinder assembly and the other is pivotally connected to the piston, the ‘mechanism being arranged sch thatthe dorsiflexion limit js defined by » mechanical stop limiting relative rotation of the first aad second pats. This mechanical stop may be the abutment ofthe piston with an end surface of the chamber ‘cushioning spring or pad maybe upplied to the top surface ofthe piston orto the opposing chamber surface in order to fncreate the resistance t0 dorsiflexion asthe dorsiflexion limit is approached As for the ability o preset the dors-flexion limit, this may be ficilitated in 3 number of ways, For instane, the limit ‘nay be set by an adjustable anterior-posterior tlt alignment interiace, typically bewoen the joint mechanism and a shin ‘component such asa shin tube, The interface may be ofthe wwellsknown inverted. pyramid constriction as described fahove, Altematively, the interface may he provided betwen the joint mechanism and a foot component. Again this may be of inverted-pyramid construction. Another possibility isa Jockable pivot joint for connecting the foot component to the joint mechanism, baving an adjustment axis running in the ‘medial-ateral direction. As a further alternative, an adjust able ead stop may be provided in the piston and cylinder assembly, or the connection between the piston and ane of ‘the components ofthe mechanism mounting the foot com- ponent or the shin component may he adjustable to alter the range of displacement ofthe piston in the chamber of the assembly with respect tothe angular range of movement of the foot component relative to the shin componentUS 11,679,008 B2 5 The preferred joint mechanism includes to passages i ‘communication with the above-mentioned chamber of the piston and cylinder assembly, exch containing a respective hon-return Valve, one oriented to prevent the flow of fluid from the chamber through its respective passage and the ‘ther oriented t© prevent the admission of tuid © the ‘chamber through the other passage, so that one permits uid flow wien the joint mechanism is flexing i the direction of don tev wie Be aber pas pei iw ok fluid when the joint is flexing in the direction of plantar- flexion. Preferably. both passges have respective ajuste able-area damping orifices o allow the degree of damping to be tuned to the user's requirements Its preferred thatthe piston and cylinder assembly is 3 hydraulic piston and cylinder assembly, although i is pos- sible to use a pneumatic assembly ‘A locking device may’ also be provided for locking the joint mechanism against pivoting at any of a. mamber of Positions ofthe feot component relative tothe shin compo- rent, Typically this is performed using ® manually or elec- teomechanieally operated valve which interrupts the flow of fluid to or fom the above-mentioned chamber of the piston ‘and cylinder assembly through the bypass passages. The locking device comprises a control member having two Positions, one in which the joint mechanism operates in & ‘yielding mode and one in Which it operates in a locked ‘mode, Retaining means are provided for retaining the con- trol member in either of the two positions, eg. a spring biasing the conteo! member into one position and a detent, latch or lock for keeping the contr member in the other position. ‘The invention also includes a prosthetic ankle unit com= prising a foot connection interface, a shin connoction inter= face pivotally connected tothe foot connection interface 10 allow flexion of the unit, a piston and eylinder assembly having a piston that is movable in a fid-illed chamber of the assembly, the piston being associsted with one of the interfaces and the chamber withthe ether so that when the shin connection interface pivots relative to the foot eonnec- tion interface, the piston moves i the chamber, Hid being admitted to or expelled from the chamber through at least ‘one damping orifice according tothe direction of flexion of the unit, wherein the unit further comprises Rexion limiting ‘means limiting dors-lexion of the unit to a dorsiflexion limit comesponding to a selected angular position of the interfaces relative to each other, and wherein af leas one oF the connection interfaces is configured to allow anterior- posterior tlt adjustment ‘The invention will be described below by way of example with reference to the drawings BRIBE DESCRIPTION OF THE DRAWINGS In the drawings FIG. 1 is a cross-section of a footankle prosthesis in accordance with the invention, including a first ankle unit, sectioned on a central anterior posterior (AP) plane: FIG. 2 js a cross-section of an alternative ankle unit for use in a prosthesis in accordance with the invention, sec- tioned on au AP in front of the central AP plane; FIG. 3s an anterior elevation of the ankle unit of FIG. 2; FIG. 4 is a detailed cross-section, taken on a medial= lateral plane, of the ankle unit of FIG. 2, showing a locking valve IG. § is a diggram illustrating the ankle yielding range alforded by a prosthesis in accordance with the invention ‘and 0 o 6 PIG, 6 64 diagram illustrating operation of a prosthesis in accordance with the iavention during walking, DETAILED DESCRIPTION OF THE DRAWING Refering to FIG. 1, an footankle prosthesis in accor- dance withthe invention has foot component 10 with foot Keel 12 comprising a rigid cari 124, and a toe spring 128 and heel spring 12C which re independently coupled to the carier 12A. The keel 12is a one-pieve component made froma carbon fibee composite material and is surrounded by a foam cosmetic covering 14 ‘Mounted othe foot kee 12 san ankle unit 16 comprising joint mechanism 18 and a shin eonnection interface 20 The shin connection interface 20 defines a shin connection axis 22, The mounting ofthe ankle unit 16 w the foot keel 12 is by way of an ankle flexion pivot 24 defining 2 flexion axis 24 running ina medialtteral direction tothe anterior Of the shin connection axis 22. “The body of the ankle unit 16 forms the eylinder of a piston and eylinder assembly having piston 28 with upper fn lower piston rds 284, 283, the lower piston rod being pivotally connected to the foot keel 12 at # second pivotal connection 30, this second pivotal connection defining @ second mevial-lateral axis which is spaced, in this case posteriony from the flexion ais 244. It wll be seen tat as the body 16 of the ankle unit pivots about the flexion axis 244, the piston 28 moves substantially linearly’ in the cylinder 26 ‘The evlinder 26 ofthe piston and eylinder assembly is, dived ito upper and lower chambers 268, 261. These chambers are linked by two bypass passages inthe ankle unit body 16, one of which is visible in FIG. 1 where itis shown by dotted lines since it is behind the sectioning plane ofthe drawing. The other passage does not sppear in FIG. 1 since itis located in font of the sectioning plane. However, is configuration is almost identical, as wil be desribed below. ‘These two bypass passages communicate with the upper chamber 26A of the cylinder via a locking valve. 32, deseribed in more detail below, and a common linking pasnige 34 which opens into the upper chamber 264. The two bypass passages, one of Which, 36 is shown in FIG. 1, each contain a damping resistance conteol valve constititing @ manually adjustable area orifice 38 and a on-etum valve 40. This adjusublearea eifice and the non-retum valve 40 are aranged in series in the bypass passage 36 between the locking valve 32 and the lower chamber 268, ‘The bypass passage 36 appearing in FIG. 1 has its ‘non-retum valve 49 oriented to allow the flaw of hydraulic {uid from the lower chamber 263 to the upper chamber 26A. The other bypass passage (not shown} has its non- ‘return valve oriented inthe opposite direeton, Accordinly. fone of the passages 36 is operative during dorsiflexion and the other during plantaflexion, When the locking valve 32 is open, continous yielding movement of the foot eompo- sent 10 relative to the ankle unit 16 about the flexion exis 244 is possible between dorsiflexion and plantrflexion limits defined by the abutmeat of the piston with, espee- tively, the lower wall and the upper wall of the eylinder 26 ‘The level of damping for dorsiflexion and planarflexon is independently and manually presetable by the respective agjustable-area orifices “The shin connection interface 20 is conventions, being of pyramid constriction. Typically a rubulr shin component is ‘mounted to the shin coancetion interfce 20, the shin com- Poneat having, at its distal end, an annular female pyramidUS 11,679,008 B2 1 receptacle having slignmeat serews, as well knowa to those skilled in the ar, for adjusting the orientation of the shin ‘component relative tothe ankle unit 16. Ata nentral align= ‘ent position, the axis of the shin component (the shin axis) js coincident with the shin connection axis 22 (shown ia FIG. 1), When the shin component is afixed tothe ankle unit 16 in this neutral position, the limit of dorsi-lexion of the snkle-foot prosthesis, defined by the sbutment of the piston 28 with the lower wall of the cylinder 26 corresponds to an ‘anterior Git ofthe shin axis relative to the vertical when the user stands ona horizontal sueaee, The plata flexion limit, ‘defined by abutment of the piston 28 with the upper wall of the cylinder 26 comesponds toa posterior tilt of te shin axis In this embodiment, the anterior and posterior lt angles ‘of the shin connection axis 22 at the dorsiflexion and plantarflexion limits are 4 degrees (anterior) and 8 degrees (posterior) respectively with respect tothe vertical In this embodiment, the mechanical end-stops represented by the abutment of the piston 28 with the lover and upper ‘contol of a hyde damping range. There is no nocd for ‘2 pendulum as in some prior art arrangements, nor for ‘electronic contol at every step. The damping range is se ‘mechanically, the linear piston arrangement being preferred for simplicity and reliability. Independent dorsi plantarflexion valve adjustment is provided, allowing Improved setup and customisation of foot performance 19 sui the roguieaents of individual amputees. The prefered oot and ankle combination represents a visco-elastc siie- ture according tothe Maxwell model, ie the damper of the ankle joint mechanism acts in series with the resilient part of the foot. The hydranlie damping is active on step-by-step basis, 5 opposed to being’ substantially locked on some steps. ‘What is claimed is: 1.4 prosthetic Toot and ankle assembly comprising @ ‘combination of: foot component, and fa ankle joint mounted to the foot component and having fixed range of dorsi-plantar flexion during walking, ‘wherein a lower end of the ankle joint is pivotally ‘mounted tothe foot component ata pivotal connection about which the fixed ringe of dorsplantar Hexion ‘occurs, the ankle joint comprising a joint mechanism comprising a linear liydmaulic. damper providing hydraulic damping resistance during. ankle flexion ‘whenever the ankle joint is flexed, the Tinear hydraulic damper having a pie of variable-volume chambers and a valve amangement controlling the flow of hydraulic uid between the chambers, the valve arrangement comprising a first, locking valve, a second valve and thied valve, the locking valve having a fit orifice and aanged 10 ‘operate in locked mode and in a yielding mode, wherein inthe locked mode the first orifice is closed and the locking valve prevents both dorsi snd plantar flex- ‘on ofthe ankle joint and inthe yielding mode the fist orifice is open and allows both dors and plantar Hexion of the ankle joint, the second valve comprising « second orifice that is ‘adjustable in area by a second flow control valve ‘clement to pre-set dots-lexion damping resistance, the sevond orifice and the second flew contol valve cle- ‘ment being disposed in a second passage extending from one of the pair of chambers to a bore, wherein 3 ccommon passage further connects the bore vith the ‘other ofthe pair of chambers, lexion and 2 12 the thin! valve comprising. thind orifice that i adjustable in area by a third flow contol valve element to pre-set plantar-iexion damping resistance, ‘wher the locking valve is disposed within the bore and ‘configured to prevent fd flow into oF out of the ‘common passage in the locked mode and permit id flow into and out ofthe common passage in the Yielding mode, ‘wherein the second flow control valve element is operable independent of the third How control valve element t0 independently pre-set the dorsiflexion damping lance and the planiar-flexion damping resistance such that during walking the second orifice is pre-set 0 provide hydraulie damping ata fist setting whenever ‘the ooking valve is inthe yielding mode and the ankle joint is Heed in a dorsiclexion direction, resistance to ankle dorsiflexion being. predominantly provided by Inydraclic damping resistance, and the thd orifice is pre-set to provide hydraulic damping at a second set- ling whenever the locking valve is in the yielding mode ‘and the ankle joint is flexed in a plantar-flexion diree- tion, resistance to ankle plantar-flexion being predomi nantly provided by hydric damping resistance, and wherein the ankle joint is configured and arranged such ‘that during walking when the locking valve is in the ‘yielding mode the dors-lexion limit reached during the stance phase ofthe git cycle when walking on level ‘round 2.,A prosthetic foot and ankle assembly as claimed in claim 1, wherein the locking valve comprises a retaining ‘mechanism for maintaining the locking valve in one or bath of the locked and yielding modes. 3. A prosthetic foot and ankle assembly as claimed ia claim 1, wherein the locking valve is manually operable. “4. A prosthetic foot and ankle assembly as claimed in claim 1, wherein the Iocking valve is eleciromechanieally ‘operable '5. A prosthotc foot and ankle assembly as claimed in claim 1 wherein the joint mechanism incades fis ps sage and a second passage, each passage being in comm ication with each of the variable-volume chambers, the frst passige containing the second valve anda first non-return valve and the second passage containing the third valve and ‘second non-retum valve, the fist non-retum valve being ‘oriented to preveat the Now of fuid between the chambers ‘through the first passage in first direction and the second son-retim valve being oriented to prevent the hss of Mid between the chambers through the second passage ina second diretion 6. A prosthotc foot and ankle assembly as claimed in claim 1, wherein the joint mechanism includes a first lexion Jimiter that limits dorsiflexion ofthe joint mechanism to a dorsiflexion limit and a second flexion limiter tht Himits plantar flexion of the joint mechanism to ®plantar-flexion Timit, thereby defining the fixed ringe of dorsi-plantar Nex: "7. A prosthetic foot and ankle assembly as claimed in claim 1, wherein the joint mochanism is non-electonically ‘controlled and the hydraulic damping provided by the linear hydraulic damper is non-electonieally controlled. '8. A prosthetic Toot and ankle assembly as claimed in claim 1, further comprising st least one pyramid alignment interface allowing adjustment ofa shin axis orientation in an Anterior-posterioe direction with respect ta the foot compo ent 9. A prosthetic foot and ankle assembly as claimed in claim 1, the assembly further comprising «cushioningUS 11,679,008 B2 13 device for increasing resistance to dors-en the ankle joint approaches the dorsi-lexion limit. 10, \ prosthetic foot and ankle assembly as elsimed in claim 1, farther comprising a shin connection interface, ‘wherein the assembly Is arranged such that the dorsiflexion limit corresponds to a predetemnined relative orientation of the shin connection interface relative to the foot component. 1. A prosthetic foot and ankle assembly as claimed in ‘lain 1 Wherein the third orifice and the third flow contol valve element are disposed ina third passage extending from the one of the pair of variable-volume chambers to & bore separately from the second passage. 12, A prosthetic foot and ankle assembly as claimed in ‘laim 11, further comprising a piston separating the pair of ‘ariable-volume chambers, wherein he second passage and the third passage are defined in the ankle jot separate Irom the piston. 13.-A prosthetic foot and ankle assembly as claimed ia ‘laim 12, wherein the locking valve comprises a spool valve configured 10 translate axially along the bore between the Jocks mode and the yielding mode. 14, A prosthetic foot and ankle assembly as claimed in valve element is defined inthe ankle joint separate from the piston, and wherein the third valve inchoding the thind orifice ‘and the third flow contol valve element is dfiaed in the ankle joint separate from the piston. 15, A prosthetic foot and ankle assembly as claimed in ‘lain 1, wherein the socond flow control valve element and the third Mow control valve element each comprise serews ‘configured to he manslly rotated to respectively indepen- dently adjust the areas of the second orifice and the third orifice, 16, A prosleie ankle unt comprising a foot connection inerface and a shin connection interface being pivotally ‘connected by an ankle joint mechanism having a fixed range ‘of dors-plantar flexion during walking, the joint mechanism ‘comprising a lineae hydealic damper providing hydaulic ‘damping resistance during ankle lexion whenever the ankle Joint’ mechanism is flexed, the linear hydraulic damper having a pair of variable-volume chambers and valve ‘erangement controlling the flow of hydeaulie Hud benveen, the chambers, dhe valve arrangement comprising a first locking valve, a second valve and third valve, the locking valve having a first ofitice and arranged (0 ‘operate in locked mode and in a yielding mode, wherein inthe locked mode the first orifice is lowed and the locking valve prevents both dorsi and plantar flex- 14 ion of the joint mechanism and in the yielding mode the first orifice is open and allows both dorsi and plantar flexion ofthe joint mechanism, the second valve comprising a second orifice that is ‘adjustable in area by a second flow control valve ‘clement o pre-set dors-lexion damping resistance, the second orifice and the second flow conto] valve ele- ment being disposed in a socond passage extending fiom one of the pair of chambers to a bore, wherein 3 ‘common passage further connects the bore with the ‘ther of the pair of chambers the thin valve comprising a thind orifice that i adjustable in area by a third flow contol valve element to pre-set plantar-exion damping resistance, ‘wherein the locking valve is disposed within the bore and configured to prevent fd flow into or out of the ‘common passage in the locked mode and permit Nid flow into and ut ofthe common passage in the yielding mode, ‘wherein the second flow control valve element i operable independent of the third ow contol valve element t0 independently pre-set the dorsi-flexion damping resis tance and the plantar-flexion damping resistance such that during walking the second orifice is pre-set t0 provide hydraulic damping ata fist setting whenever the locking valve is in the yielding mode and the ankle Joints flexed in a dorsitleion direction, resistance 10 ‘ankle dorsiflexion being. predominantly provided by hydraulic damping resistance, and the thin orifice is pre-set fo provide hydraulic damping at a second set- ting whenever the locking valve isin the yielding mode and the ankle joint is flexed in a plantarflexion dire tion, resistance to ankle plantar-lexion being predomi nantly provided by hydraulic damping resistance, and ‘wherein the ankle joint is configured and arranged such ‘that ducing walking when the locking valve is in the yielding mode the dorsi-lexion limit i reached during ihe stance phase ofthe gait eyele when walking on level ‘round, 17. Aprostetic ankle units claimed in elaim 16, wherein the Tocking valve comprises a retaining mechanism Tor ‘maintaining the locking valve in one or both ofthe locked and yielding modes. 18. Aprostetic ankle units claimed in elaim 16, wherein the locking valve is manually operable, 19. Aprostetic ankle nitas elaimed in elaim 16, wherein the locking valve is electromechanically operable.