CA2197069A1 - Apparatus for reducing circumference of vascular structure - Google Patents

Apparatus for reducing circumference of vascular structure

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Publication number
CA2197069A1
CA2197069A1 CA002197069A CA2197069A CA2197069A1 CA 2197069 A1 CA2197069 A1 CA 2197069A1 CA 002197069 A CA002197069 A CA 002197069A CA 2197069 A CA2197069 A CA 2197069A CA 2197069 A1 CA2197069 A1 CA 2197069A1
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CA
Canada
Prior art keywords
suture
vascular structure
support segment
circumference
suture support
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002197069A
Other languages
French (fr)
Inventor
William F. Northrup, Iii
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MedicalCV Inc
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2197069A1 publication Critical patent/CA2197069A1/en
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406—Pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus

Abstract

An apparatus for reducing the circumference of a vascular structure (50) comprising a plurality of sutures (60) and a plurality of discrete suture support segments (10) of a biocompatible, inert material, each suture support segment having at least two suture holes (24 and 26), spaced a predetermined distance (D) apart. A biocompatible, inert stabilizing material (70) may optionally be affixed over the suture support segments and the vascular structure prior to tying off the suture to stabilize the interval between the suture support segments and eliminate direct exposure of the segmented apparatus to blood.

Description

Wo 96104852 2 1 9 7 0 6 9 Apparatus for Reducin~ Circumference of Vascular Structure nlcl~ "(l nf Illc Tnvcnlioll Thc prcscnl invClllioll rcl;ncs SCl)Cr;llly 10 r,n :Ipp tr~us ~nd mcLhod ror rcducins tllc circunircrcncc or ;I vcsscl, ;uld morc p;~rLicul;lrly to ~n ;Ipp~r~us :md mcLhod ror rcduchls Ihc circumrcrcncc or v:lscul;lr slluclurcs, includins c;lrdi~c Y;IIYCS.
All ;Irlirlci;ll or proslllclic llc:lrl v;llYcs, ~vllclllcr nlCCII~II;C;II or l~iuylu~ llhou~ rc:llly improvill~ Ihc condjljoll ot ~hc p:llic~ YC SOInC
scrious dr;l~vl~cl;s; mmcly Ihrolllbo~cllicily (Icndcllcy low;lrds Ihrollll~us form:llion ;md subscqucnl dct;lchlllclll ~viLII rml)oli~ inl-), ;uld limilcd dur;ll~ilily sccond;lry lo tissuc s~luclurc tidlurc.
Olhcl Colllplic;lliolls sllch :15 noisc, hllcrrcrcllcc willl l,c,.lo-lyll~-"li~,cspcci:llly hl sm:lllcr sizcs, llcmolysis (~Ics~ruc~ion Or l)lood clcmcllls), ris}; or o l~l~clic~~l in :dl p~ iCIlls ~vho rcccivc IllCCh:llliC:II Y;IIVCS, cndoc:lrdilis (v~lYc infcctioll) ~nd dchisccncc or Illc v;llvc ;llso occur. I~cc;lusc or ~hc risl; of cmbolism, ~hc m;ljority of p;lticnls wllo ICCCiVC ;IrlirlCi;ll hc;lrl v;llvcs nccd to l;llic ~ntico~sul;llivc mcdic;llion ror lirc ~vi~h Ihc rnr~romil~ risl; crl~ ..,I,I,I"~.C, ;md ~0 ncccss~ry chansc in l;rc slylc.
Difrcrcnt ;uld morc rcccnl dcvcloplllcms in Illc rlcld o~ c;lrdi~c surscry - includcd :ll~cmp~s ~o sursic:llly rcp~ir disc:lscd v:lscul:lr lissuc, in p;lrlicul;lr, hc:lrt v:llYcs. A v:lricly cr sur! ic:ll m:lllcuvcls or proccdurcs h~vc bccn uscd ror ~liis purposc. This Iypc Or rcconsn~lc~iYc sur~cry h;ls bCCII sho~vll 10 l~c supcrior to v~lvc ~5 i-l,l,.c.",-,-l in m:uly rcspccls.
Rccollslruclivc surscly, ho~;~cvcr, is ~cncr:llly morc dirrlcull to pcrform Ih:,ll l.pl;lcc,l,."L ;Ind is nol ;ll~v:lys possiblc in cvcry p:~licnt. Amon~ thc varicty Or rcconslruclivc m:lllcuvcrs, v:llvc :ulllulopl:lsly is Ihc mosl rrcqucnlly pcrrormcd in Ihc tricuspicl :uld milr:ll v:llvcs. V:llvc :mnulopl:lsly is ;In opcr~lion 3û ~vhicll sclcclivcly rcduccs lllc sizc Or Illc v:dvc :Innulus. I~or Illis purposc, ;I numhcr OrPrOSIIICI;C 1;11r~5 II;~VC bCCII dCVCIOPCd rOr IIIC :nr;OVCIIIr;CUI;Ir V:IIVCS. OIIC SUCh wcll l;nown comlllcrci;llly ;Iv;lil;lblc rhls is Illc C:upclllicr (dislributcd by Amcric~n Edw;lrds Lal)or;ltorics) rillS

SUBSTITUTE SHEET (RULE 26) - -W096/04852 21 9 7 0 69 r~ 9 .

Thc C;lrpcnlicr mclllod or v;llvulopl;~sly cmpioyhl~ Illc C;lrpcnticr rin~
is discloscd in tllc producL p;ullplllc~ Pros~hcLic Rill~s ~nd Acccssorics for Tricuspid arld Mitr;ll V~lvulopl~sty produccd by Amcric;lll Edw;lrds T ~llrr~lnl ir in Dcccmbcr, 1935.
C;lrpcnticr ct ;11. U.S. P~lcnl Nc.5,061,277 rcl;llcs Lo ~ iicxiblc cardi;lc Y~lvul~r support prosthcsis whicll is scncr;llly rin~ sh~pcd ~nd h;ls ;~ rlrst Icnsth whicll is ncxiblc ;Ind ;I sccond Icn5111 wllicll is Icss iicxiblc Ih~n thc first lenstil so thc support m:ly sh;lpc ~hc ~nllulus ~vhilc thc rlrst Icnsth of thc support in pl;lcc in ~ hc~rt v;llvc ilnnulus ;Illows conlr;lcliotl Ihcrcof.
C;lrpcnlicr ct ;lh U.S. I';llclll No.4,917,69S rcl;llcs lo ;I mulLi-sc51llcll~cd ;umulopl~sly rins proslllcsis ror usc in illc sursic;ll corrcction or a dcformcd hc~rl v;~ c wllicll providcs ;l subsl;ulli;llly circul;lr body comprisills hl p;lrt scsmcnls joincd to~clllcr by llcxiblc joinls ~hc body bchl~ sh;lpcd in proportion to ~llc ~lmulus or ;I llc;lr~ v;llvc.
Dur~n U.S. I ;ltcn~ 5,7513,021 rcl;llcs to ~ Sismoid V~IYC
Annulopl~sty Rins in ;I sc~llopcd sh~pc h;lvill~ Ihrcc shlusoid;~l struts to ad;lpt to tbc ~n;~tomic~l sh;lpc of thc ;mnulus or Illc hulll;lll sigmoid v~lYcs. Thc rhls is madc of ;~ hi~-rr,~np~ 8 m~lcri;ll covcrcd willl ;I bircr~ lr~iblr cloth.
L;ull ct ;11" U.S. P;l~cnt No.5,10d"407 rcl;l~cs to ;I sclcc~ivcly ficxibic :lnmllrpl~ly ring for sulurins lo Ihc ~nnulus or ;I hcort v;ll~c Ihc ~nnul;lr rins comprishl~ ;I p;lrli;llly ncxiblc Icn5111 ;uld ~ p;lr~i;llly ri~id ICII5III. Thc rinS is coYcrcd hl ~ sulur;lblc m;l~cri~l.
~rishl cl ;11., U.S. P;l~cn~ No.5, 01,~30 rcl;l~cs to Mitr;ll ;md Tricuspid Almulopl;lsly Rings h;l~ ins ;1 unil;lry construc~ioll willl hllcrn;ll dl.lw~
;md ;I scmi-ficxiblc s~irrcncr in Ihc ~ntcrioi scsmcnl.
Cossrovc ct ;11. U.S. Palcllt 5 041 130 rcl;lLcs lo :m ;Isscmbly for holdills ~ subs~:ln~i;dly ficxiblc Icn~icul~r sh;lpcd ;mnulopl~s~y rins in ;I posi~ion for su~urins ~bout ;I Y;llYC ;mnulus. Tllc unil;lry ;mllulopl;lsly rins ~ pl ~1 thcrcin is subst;mti~lly iicxiblc ;Ind is p:lrti;dly circumlcrcnli;~ only thc postcrior mitr;ll ~Imulus.
Rccd U.S. P;llclll 4,4S9,446 rcl;llcs lo ;m ndjust;lblc hc;lrl v;~ c proslhcsis ~Yilll unitar,Y COllslluctioll includins ;I dyn;mlic stiffcncr clcmcnt.

SUBSTITUTE SHEET ~RULE 26) -Wo 96~04852 2 1 9 7 0 6 9 r~ 9 Gilbcrtsol~ ct al U.S P;~lcl~ No. 5 064 431 rciatcs to im :lnnlllnr~ y r in~ Or Lubular consLIucLiol~ cludill~ d...~..tl;l b. sclcctivcly rdjustablc to ildjust ~llc almulus to a dcsircd sl~apc.
Mycrs ct al. U S. PaLCAL No. 5 011 4S1 rclatcs to a l~oldcr for ~n 5 :Inmllf)pl~ty rin~ for usc iA i"-p ~
Comlllcrciillly ;Ivailablc allAulopl;lsly rillSs bilvc scvcral drilwb;lci;s First tl~cy arc CXpCASiVC. SCCOA(I ul~lcss tllcy arc ci~llcr risid or suturcd to tllc tissuc almulus wllilc still attacllcd to ;I ri~id lloldcr tllcy mi~y not providc a prccisc prcdictablc rcproduciblc :~nl~ c~ y bccausc Or lllc unprcdicLlblc dcsrcc of 0 Inn~ihl~ sllortcAiA~ ons IIIC circumrcrcl~cc Or LIIC suLurcs wiLl~in tl~c coArlAcs of cacll n ;l~lrcss su~urc uscd to sccurc ~llc rin~ ~o ~llc ~issuc aAI ulus E;lcl~ suturc is ncccssalily ~icd wi~ll Vari;lblC iln(i unplc(iicL;Iblc dc~rccs Or ~cnsion by ~l~c opcriltil g sur~gcon.
Tilird IIIOSt Illi(r~ s jllC colllplclcly circuAIrcrcAti~l COAullittiAs 15 Lhc opcratill~ surScon to placill~ suturcs in tllc antcrior imu~ulus wl~crc dilatil~ioA
r trcl)~ occurs and whcrc a tissuc tcar from illcxact suturc placcmcnt c~n producc si~nificimt mitml rc~ur~iLa~ion Four~ll a risid mitral rin~ bccausc it is prcsl~ped to an oval ~ if l,l n ust bc prcciscly placcd or nn l-n~ f:~rtn~y ilMUlOplilsty may rcsul~ Fiftil a ri,id tricuspid ril~ cal~ dcl~iscc if not m ~de to conform to dlc 20 sli~ tly spiral nonplimar shapc of thc ~issuc ;mnulus Six~h any riSid rin~ prcvcnts dlc normal ncxibility of thc ~issuc ;Im~ulus Or ~l~c aL~;u~ i ulilr valvc durinsvcn~ricub~r coA~ri~ction A nccd cxists ror i~n appar;lLus an(i mctho(i which providcs a cus~omizcd aMuloplils~y tailorcd to tl~c nccds of Spccirlc pathu~ iolo~
25 situ;~tions includin~ but not limitcd lo a li;nilcd lnll~lnp~ y or ~u-~ln~ ulu~ ty of any valvc aMulus a subtol;ll almulopl;lsiy of ;UIy villvc or a complcLc a.,.,.dul~ ty of ally v~lvc almulus. ~ ncc(i ;dso cxisLs lor an app;lril~us and mc~llo(i wl~ich allows Lhc rcpaircd vilscular structurc to rctail~ iLs llcxibility in all pla~cs whilc prcvcntin~
furthcr dil;ltltion or circumrcrcl~tiill lfl~ fll~ of Lhc Lissuc ~mnulus or VilSCUIar 30 StlUCtUrc It l~as bccn roun(i tlulL lo acllicYc sucll objccLs a comA~crciillly avi~ilablc aMulûplas~y ril-~ is not ncccssilry. Such objccts may bc cfrcctcd throu~ll ~ ~' SUBSTITUTE SHEET (RULE 26) . ~ . . . . . ~

21 9706q wo 96/04852 P~~ J;
usc and Impll~n~ ~inn of all almulopl;lsly dcvicc complisills ~ scrics Or discrc~c suturc support scgmcnts Summ~rY o~ thc Im~cntion .. , , ~ . . ................ . .
Tllc b;lsic ~nd sulcr;ll objcc~ of thc prcscnt invcn~ioll is to providc ~t 5 mcthod and ~pp~r;ltus Ih;lt m~int;lills ll~c norm;ll sh;lpc of a vcsscl or induccs tllc vcsscl to rcsaill ils norm;ll sh;lpc Morc spccirlcally, wllcll pcrforlllills a valvc annuloplasty"llc objcct of tllc prcscnt invcntion is lo impl;lllt a dcvicc wllicll rcduccs thc circumrcrcncc Or a discascd cardi;lc v;llvc annulus or vascul;ll StlUClUlC lo Ihc dcsirc~J si;Lc. Spccifically, 10 rnrrJ~i~irninlT of displaccd all(l blrnl1lr~ valvul;lr cusps and commissurcs or rcduclion alld rcmodclill~ of annul;ll or vascul;lr dil;ll;llioll by prcciscly dcrmcd plic;lliol~s (luc};s or rOI(ls) ;IL spcci~icLI poillLs is crrCclc~
Thc invcnlivc mCIIIOd Or rCdUCing lhC circumfcrcncc of a vascular stlucturc havins an uppcr portion and a lowcl portion, said uppcr and lowcr portions 15 cr tl c vascular sLIucLurc dclmin~ an uppcr circumrcrcncc and ;~ lowcr circlllllrr~rnrrc of said v;lscular structurc, colnpriscs Lhc sLcps of 3) providins a plur;lliLy of discrcLc suLurc support scsmcnts of a bir,~ iblr incrt n atcri;ll, ClCh SULUrC SUppOrt scsmcnt furtl~cr comprishls an uppcr surfacc, a lowcr surfacc, oppositc sidcs, a proxim~l cnd, a distal cnd and at 20 Icast t~vo suturc holcs cxtcndins from thc uppcr surfacc to thc lowcr surf~cc thcrcof and bcins spaccd a prc~lr~rnlillrrl disl;lllcc ~'D) ;Ip;lrt;
b) proviclh~ a suLurc;
c) individu;llly suLurhls c;lch suLurc supporL scsmcnt to thc vasculnr structurc whosc circumfcrcncc is to bc rcduccd by mcans of a horizontal25 m;ltLrcss (U-sh;lpcd) suLurc aiol-~ Lhc v;lscul;lr sLrucLurc Lhrou~h a Icn~th of Lissuc of thc vascular sLrucLurc such III;IL thc ICII~III (D-) of tissuc suturcd is ~rcatcr than distancc (D); and d) tishtcllinL~ ;md Iyill~ off ~hc su~urc, whcrcby cach su~urcd scsn~cnt crcaLcs an imbrication in thc vascular sLructurc, 30 thcrcby rcducins thc circun fcrcncc Lhcrcof by an amount cqu~l to (D') - (D) Altcrn;ltivcly, Lhc mctllod m;ly comprisc ~llc fur~hcr s~cp of afrlxins L
ll;or " '~I' "il~lr~, incrt stabili~ills ma~crial ovcr Lhc suturc support scsmcllts and thc vascul~r structurc by mcans of horizolltll ma~rcss suturcs throuoh c~cll suturc SUESTITUTE SHEET (RULE 26J

~ wog~ 2 1 97D69 T~ J

- support scSment and Illrou~ bc lissuc or Lllc vascular s~ cLurc, said st;lbilizins m~tcri;ll bcin~6 of prr~lr~r nllinrd dilllcllsiolls surricicnt ~o covcr Lllc su~urc support sc~mcnts affixcd Lo Ll)c vascular sLrucLurc, Lllcrcby sLabilizin~ tllc inLcrYal bc~wccll tllc suturc support scsmcnLs in ordcr lo prcvcllL rurtllcr lcnf~llu~nin~ of Lllc Yascular S structurc, and t~limin~in~ dirccL cxposurc of Illc sulurc support scsmcnts to blood.

Bricrl)escrinLion of thc Fi~urcc risurc 1 is a pcrspcc~ivc vicw Or a su~urc suppor~ scsmcnt of tbc prcscnt invcn~ioll;
Fisurc 2 sllows a ~op vic-v of a v;lscul;lr sLIuc~urc (i.c., mitral valvc) upon ~vllicll suLurc supporL scsmcll~s ror rcducinL Lllc circumrcrcllcc of a vascular structurc accordins lo Illc prcscnL i!lYCIl~iOII arc bcin~ suLurcd;
risurc 3 sho~Ys a lop vicw as in Fi~ulc 1 wllcrcin Lllc Lissuc of tbc Yascular structurc llas bccn imbric;l~cd accordin;, to ~bc prcscnt inYcntion;
Fi~urc 4 is a top YiC~Y as in l:i~urc 1 sllowinS tllc suLurc support scgmcnts in placc on a vascular s~ruc~urc (i.c., milr;ll valYc) wllosc circumfcrcncc is tllcrcby rcduccd accordins lo Lllc prcscnL invcnLioll;
Fisurc S is a top vicw as in Fi~urc 1 showin~ opLional fix~tion of tbc st;lbilizin~ ml~crial oYcr ~llc su~urc suppor~ scL~mcms;
Fi~urc 6 is a top vicw as in FiSurc 1 sllowins Lllc suLurc support scsmcnts and stabilizins m;lLcri.ll in placc;
Fi~urc 7 is a ~op vicw or a complc~c miLral valvc annlllrlrl~cty accordin~ Lo Lllc prcscnL illYCllLioll;
Fi~urc 3 is a top vic-v of an aorLic valvc col~ul~ ulu~ Ly (localizcd ~nmllorl~cry) accordi~ o Lllc prcscllL illYCll~iOII;
Fi~urc S is a top ViC~Y Or ;l Lricuspi(l valYc a~ululu~ y according to ~hc prcscn~ inYcntion;
Fisurcs 10 is a Lop YiCW of ;l t OmmiCc~r.ll IrnlllOpl~c~y of a scmilunar valvc;
Fisurc 11 is a sidc YiC~Y of a cnlllmicc~ annuloplasty of a scmilunar valvc;
Fi6urcs 12 and 13 arc vicws or a sLabilizins ~nnnlorl~cty of tllC aortic YalYC ;IMUIUS in an ilortic v;llYc-sparins root l-.lJI.IL~ IIL WiLIl a dacron conduit, SUBSTI, UTE SHEET (RIJLE 26) , . . . ~, 2~ 97rJ69 wo s6/048s2 ' I _." - 5 Fi~urc 12 bcin~ i~ sidc vicw of 5t~ ;".. l'rol11 Lhc ou~sidc of ~hc lu.,o.~LIu.~cd aorLic root rlnd ~ urc 13 bch~ ~ YiCW Ornll opcncd ;~ort~ showil1s ~l1c c~hjli~ jn from thc insidc or ~hc rccons~ruc~cd aor~ic root;
Fi~urc 14 is a top scclion;ll cul-away vicw of a lcfl vcntricular outrlow trrct showin~ thc lcvcl of IhC s8.lbilizil1~ ~nnnl(lp~ y immcdi;llcly bclow LhC aorLic valvc (as showl1 in Fi~urcs 12 and 13).

~Ctailctl T)CCCr;ntit)n OF tl1C Tn~Cnl;nl1 Whilc tl1is h1vcnLion n1;ly bc cmbodicd h1 m;my dirfcrcnt rorn1s, lhcrc arc dcscribcd h1 dctail hcrcill spccil'ic prcl'crrcd cllllo~linl~nl~ cr Ll1c h1vcllliom This dcscripLiol1 is an cxcn1plirlc:lLiol1 Or ~hc pril1cil)lcs Or tl1c invcnLiol1 and is not intcndcd Lo limi~ ~hc illVCll~iOII ~O Lhc par~icul;lr cmbodilllcllLs illusLr~Lcd.
Thc prcscnt invcnLiol1 providcs ;U1 app;lrilLus al1d mcthod ror rcducin~
thc circumrcrcl1cc of ;I vascul;lr struclurc. Tl-c prcscnL invcl1~ion also providcs an ~ppara~us ~nd mc~hod ror pcrm;ll1cl1~ly rcconstruClil1~ ;I vascul;lr strucLurc to a normal confi~uration, to rcslorc i~s ori~inal forl11 and runcLion, Thc apparatuscompriscs ~ plur~lity of suturc support scgmcn~s lil;c th;lt sho~Yn ~cncr;llly at 10 in . Fi~urc 1, suturcd to a vascular struc~urc, A plur;lli~y of suturc support sc~mcnts is shown in pl:lcc ~cncrally ~t 100 h1 I:i~urc 4. As shown in Fi~urc l, cach individual suturc support sc~mcnt 10 compriscs al1 uppcr surracc 12, a lowcr surfacc 14, opposiLc sidcs 16, 1~, ;I PrO~;illl;ll Clld 20, al1d ;I disL;Il cnd 22. EaCII suLurc support sc~mcnt 10 has aL lc;lsL LWO su~urc holcs. Tllc n~ 1o-limr~l~ shown at Fi~urc 1 hils a first suturc l1olc 24 ~nd ~ sccond su~urc l10lC 26 cxLcndil1s rrom uppcr surFacc 12 to lowcr surf;lcc 14, sp.lccd ;I prr~lr~rrlllillrtl disL;Illcc (D) ~plrt, Suturc holcs 24, 26 should bc l;lr~c cnousl1 ~o ~nColll'llnrl ~ '2-0 suturc ~nd swcd~cd-on nccdlc, In addition, suturc holcs 24,26 SIIOUId bc smooLl1 in ordcr to prcvcnt suturc frayin~ or CutLin~ whcl1 suLurc 60 ;S Licd, Thc dis8ll1cc (D) bcLwccl1 suLurc hOICS 24, 26 InaY
bc varicd, alLhou~h an intcrval of 5111111 ( -I-3 111111) rrom ccntcr to ccnLcr of holcs 24, 26 is suitablc, AlLhoush al1y suiLablc suLurc m;ly bc uscd. Lhc most prcrcrrcd as shown in LhC rlsurcs has ;I SWCd~C(I-OII surL~ic.ll nccdlc aL C;lCh cnd Lhcrcof,AIL~ ILiY~I~) a sin~lc nccdlc suLurc may bc uscd, SU~STj, ~ I E SHEET (RULE 26) ~VO 9C/04852 2 I 9 7 0 6 q r~

Su~urc SUppOrt SC~IllCnl 10 Ill;ly bc madc of any suitablc m;ltcrial wllicll is b iorrmr~ihlr wi~h blood a~ tissuc, incr~, noll-corrosivc ~nd non-o~ ,r As ;l pMCIiC;ll IlllttCr, LIIC ma~cri;ll of wllich suturc support sc~mcnt 10 is m~dc should bc a subs~allcc allc;ldy appro~cd ror in~ra-Yascul;lr usc by Lhc 5 FDA such as tiLanium. Sulurc supporL sc~mclll 10 mus~ bc riJ id or scmi-ri~id in thc lrlnPihlriin~l dhllcnsioll, and must nol bc ~ rrlr~ cl so Ill~t it docs not bucklc whcn suturc 60 is ticd.
Altllou~ll suLurc supporL sc~mcllL 10 may bc oF ally suiLablc shapc, thc spatuiatcd shapc ShOWIl ill I:i~urc I is quilc crrcclivc. ïllc minimum dimcnsion 10 rrom outsidc cd~c oF suturc holc lo Illc cnd or sulurc support sc~mcnt 10 in ordcr to IllillillliZC IIIC Ch;lllCC oF abu~lllcn~ or ovcrl;lp or ;Idjaccll~ sulurc support sc~mcllis is about 1mm. Thc milli!1lulll wid~ o IllillillliZ.C Ill;lS5 bu~ no~ Lo allow cul~in~ illlO
tissuc is bct-vccn aboul 2mn1 - 4111111. Thc IllillilllUIII IhiCI;llCss IO rcducc mass but avoid bucl;lin~ or sulurc suppor~ SC~lllCIl~ 10 is about Inim.
Thc mclllod or rcduchls Illc circumrcrcncc of vascular shucturc is shown at fsurcs 2 - 6. As shown al Fi~urc 2, vascular slructurc 50 Ims an uppcr portion 52 and a lowcr porlioll 54, said uppcr and lowcr porlions 52, 54 dcFminf7 an uppcr circumfcrcncc and a lo-vcr circumrcrcncc oF v~scular structurc 50.
Apparalus 100 comprisin~ a plur;llily oi sulurc support scsmcnts 10.
20 Suturc support scsmcnts 10 arc individually affixcd to vascul;lr structurc 50 wllosc ulllrulLIl~.l, is to bc rcduccd, by mcans of a llorizontal mattrcss (U-shapcd) suturc 60 alollP vascul;lr slruclurc 50 Illrou~ll a Icng~h or ~issuc or Y;ISCUI;II' s~ructurc 50.
Rcrcrrin5 to l~isurc 2, tllc sulurc 60 ~raYCrsCs a lon~cr distancc alonP v;lscular structurc 50 tllall tllc distancc (D) bctwccn sulurc holcs 24, 26 of sulurc support 25 scgmcnt 10. Spccific;llly, Ihc Icnslll or dis~allcc (D') bclwccn Ihc cnlry ;md cxit of suturc 60 is ~rcalcr tball distancc (D) bchvccll sulurc holcs 24, 26 or sulurc support sc~mcnt 10. As showll in Fi~urcs 2 ;md 3, bolll cnds of su~urc 60 arc brou~ht upthrousll suturc llolcs 24, 26 of sulurc supporl sc~mcnL 10. l'hc Icn~Lh (D') or tissuc oE v~scular structurc 50 sulurcd is ~rca~cr ~h;lll dis~ancc (D), whcrcby cacll suturcd 30 sc~ment 10 crcatcs all hllbric;llioll, or lucii 62, in vascul;lr stluclurc 50, thcrcby rcducins thc circumfcrcncc Ihcrcof.
Suturcs 60, whcn ticd, will rcducc Lhc circumrcrcncc cr a Yascular structurc by ;m ~mount cqual to (D') - (D), thc dirlcrcncc bctwccn Lllc Icnstll (D') SUBSTITUTE SHEET (RllLE 26) W0 96/04s~2 ;~ 19 7 0 6 9 r~l,u~ ~ 9 c;lch individu;ll m;lttrcss su~urc 60 ~r~vcls in lllc ~issuc Or v~scular s~ruc~urc 50 ~nd tllc disl;mcc (D) bct~Yccll tllc 2 sulurc llolcs 2~ 2G in Lhc individu;ll sulurc support sc~mcnt 10. In otllcr words v~scul;~r stlucturc 50 is imbric;~tcd undcrnc tth su~urc support sc~mcnt 10 willlill tllC indiYidu;~l m~ttrcss suturc by ~ prccisc iUI10UI1t 5 dcpcndin~ on ~hc linc;lr dis~iu1cc (D ) ;doll~ ~IIC ~issuc of Y~scul;lr stlucturc 50 whicl thc individu;ll sulurc 60 tr;lvcls.
A plur;llity of sulurc support SC~IIICII~S 10 ill pl;lCC is ShOWII ~It l~isurc . .
Rcfcrril1g to l:i~urc 5 .l binrnn.p~ incrt sl~bilizins m;llcri;ll 70 I0 n1;ly option~lly bc providc(l. 1~S ShOWIl, st;d~ilizills m;llcriill 70 is ;llso ;Iffxcd oYcr Il1c scsmcll~cd ;Ipp;lr;l~us ;u1d tl~c v;~scul;lr slruclurc by mc~ns Or llorizon~;ll milt~rcss su~urcs 60 throu~l1 C;ICI1 sc~mcl1l ;u1d ~hrou~ h IIIC Lissuc Or v;lscul;lr struclulc 50.
St;lbilizins m~tcri~l 70 mily bc ;Irr~xcd lo v;lscul;lr s~ruc~urc 50 by mcans of thc s;lmc su~urcs 60 uscd ~o ;IrFx scsincl1ts 10 tllcrclo. Bo~h cnds Or suturc 60 ;Irc brou~l1t up 15 tl1rousl1 st;lbilizins m;ncri.ll 70 prior lo ~yin~ ol su~urc 60.
Altcrn;ltivcly ~hc st~bilizins n1;ltcri;~1 ;md suturc support scsmcnt m~y bc suturcd to v~scul~r structurc 50 Willl onc conlilluous suturc usins ~ sinslc nccdlc.
Tbc m;lttrcss suturc would bc crfcctcd by pnssill~ thc nccdlc ~nd suturc Frst throusl tllC st~bilizins m~tcri~l from ;m cnlry point in Illc uppcr surfrcc thcrcof throusl1 thc 20 lowcr surf;lcc thcrcof thcl1 Illrousll ~ sulurc holc in thc suturc support scsmcnt suturins thc Icnsth of tissuc Or thc ~;lscul;lr slructurc p~ssins Illc suLurc tllroush n sccond suturc holc in thc suturc support scsmcl1L p;lssins tl1c sulurc tl1roush thc sL;~bilizins m~tcri;ll rrom Ihc lowcr Sulr~cc thc-cor ~nd out ;m cxit pohlt in IIIC uppcr surf:lcc thcrcof. Thc suturc would Ihcn bc li~l1tcl1cd ~nd ticd orf such th;lt thc suturc 25 ~;not formcd would si~ on ~l1c uppcr surr;lcC of tl1c st~bilizin~ m;ltcri;ll.Al~cn1~tivcly ;1 lululins m;ltlrcss sulurc would bc possiblc by tying ;I sinslc suturc to itsclf or ~o 311 addiliOII;II suturc or by rcpc;llill5 lhc coursc cr thc runnins m;lttrcss suturc in rcvcrsc.
St;lbilizinS m;ltcri~l 70 is ol prf 8r~1 ~rmin ~ l dimcnsions sufrlcicllt to 30 coYcr spp~r;ltus 100 ~rfixcd to v;lscul;lr slruclurc 50 ;u1d m;ly ;u~urllly bc anoùhcr l~ycr of ~issuc such ;Is ;lu~olosous llnn~nln~f)~ or llctcrolosous pcric~rdium or ~Itcrn~tivcly m;ly bc m;ldc of ~ny suit~blc r;lbric such ;Is d;lcron.

SUBSTITUTE SHEET (RULE 26) Wo 96/04852 ~ 21 97~k9 ~ , s Stabilizin~ matcri;ll 70, shown in pl:lcc hl Figurc 6, stabili~cs tllC
intcrY;Il bctwccn suturcs 60, prcvcnlill~ rurll~cr dilal;~lion or Lil.ulllr~:l.llLi;d 1. ,l~,ll" .~ill~ of thc tissuc annulus or v;lscul;lr slruc~urc bctwccn suLurcs. Thc stabilizin~ m~tcrial 70 ;llso climill;llcs dircct cxposurc Or LhC sc~mcntcd ~pparatus 100 to blood.
Tl c practicc of lllc prcscnl invclllion :Ichicvcs scvcral objcc~ivcs and adv;mt~cs. Thc objcctivcs ;Ind ;Idv~n~;lgcs arc as rOIiOWs.
Thc sc~mcnlcd ;Ipp;lr;lLus of Illc prcscnt invcnLion is much Icss cxpcnsivc to producc tllan commcrci;ll allllulopl;lsly rblus, as it compriscs discrclc sulurc supporl sc~mcnls wilicll :Irc cconolllic;ll ~o producc.
Tllc ~pp~ralus ;snd mclllod ;Illows prccisc imbric;llioll willlin c~cll m~ltrcss suturc supportcd by sulurc supporL scsmcllis~ Tllis is no~ possiblc Wi~il any aMulopl;lsty dcvicc which is dcForm;lblc in a lnn~ l dircclioll unlcss lhc dcvicc is ~u~chcd to ~ ri~id holdcr v~ ilc ~hc su~urcs ~rc ~icd. Tllc prcscnt app~r;llus and mclllod ~llows ror ;m ~bsolulcly l~rccisc, prcdicl;lblc and rcproduciblc annulopl~sty.
Thc invcntivc ;lpp~r;ltus ;uld niclilod providc construclion of a customizcd ~nnuloplilsty, nol possiblc willl comlllcrcial aMulopl;lsty rin~s. A
limi~cd ~Mulopl~sly or cwlll~liaaulul/l;lsty cr ally valvc iMulus, ;Is shown in Fi~tlrcs S, 10 and 11 c~l bc pcriormcd, ;Is call I pos~crior mitr;ll v;~lvc aMulopl~sty as showll in ~i ,urcs 4 :md 6, ;Is wcll as a sub~ol;ll mn~ rl~c~y of ally valvc such as dlc tricuspid v~lvc, ;Is sbown in l~ urc 9, or a complclc ;mnuloplasty of ally v~lvc:mnulus as sllo~vn in Fi~urc 7. F~urcs 10 and 11 show a cllmmiccl~ MUIOpl;lsty o~ ~ scmilun;lr valvc. I~isurcs 12, 13 ;Ind 14 sllow ~ slabilizin~ ~nnulopl~sty of thc aortic v;dvc aMulus.
Thc discrctc suLurc SUppOlt sc~mcn~s aiiow ficxibili~y of thc annulus or v~scular slruclurc in ;dl pl;u~cs, ;m;llo~ous hl principlc to ;I ch;~in-linl; fcncc, altilou~ll thc lini;s ;Irc scp;lratc. 1'11c rcsullin~ almulopl;~s~y is morc pllysiolo~ic lila Witil a risid rin~ sincc il is ficxiblc in all plallcs. In lhc casc ûf ~hc mi~r~l and tricuspid v;llvc ;ulllulus, systolic contr;lclioll is slill possiblc.
Thc prcscn~ blvcn~ion providcs nol only ;m ;mnulopl;lsty dcvicc v,dlicl is not only Icss cxpcnsivc 1ll;lll comlllcrci;llly av;lil;lblc ;mnulopl;lsly rin~s, but ;llso ;
morc prccisc, prcdictablc rcproduciblc ~mluloplasty lh;m is providcd by any ficxiblc rinS not att~chcd to a risid holdcr whilc Ihc sulurcs arc ~icd. Thc discrclc suturc . SUBSTITUTE SHEET (RULE 26) .;
. ~ } , .

21 9706~
Vl~O96/04852 ~ /rJ~ 9 support sc~,uncnts m31;c it possiblc to rcducc Lllc circumlcrcncc Or tbc v31vc 3mlulus by 3 Spccir~c lCn~LII A customizcd ~n~ nl~l ~Iy, inclu~lill~ but not limitcd to a lirnitcd ~r~ orl~ty or u o~ ulupl.l~Ly of any v;~lvc a~mulus, a subtot31 tlmlllop~ y of ;my v31vc or 3 complcLc ~n~llllopl~cly of any v31vc ~nnulus m3y 5 tllercby bc providcd.
Rcp3ir of 3 v3scul3r slruclurc willl Illc prcscnt app3r3Lus 3nd mclllod allows tl~c rcp3ircd v3scul~r slruclurc IO rc~3in ils flcxibility in 311 plancs, 3nd iurtllcr minilllizcs tllc possibilily of dcbisccncc Or Lhc v;lscul3r sLrucLurc, 3nd thc possibilily of furlllcr dil3t3lion, or circumrcrc~ r-llrrlllrnilll. cr illc v3scul3r 10 stlucturc. I~urlllcr, tllc possibilily of r3ilurc of Illc prcscnt 3pp3r;11us wbcll in placc 3t Illc Lissuc ;mnulus is lcsscncd by provi~ liscrclc suturc suppolt sc~mcllts Convcrscly, ;1 ri ,id, unil;lry 3nllulupl;lsly rin~ wllcll impl;llllcd will by dclulilioll rcsist any pllysiolo~ic;ll motion cr LIIC lissuc 3Imulus ciLllcr dowmv3rd (3w3y from tbc lowcr surf;lcc of tllc ring) or imv3rd (low;lrd lbc orirlcc Or Lllc rin~), 3nd m~y 15 ~hcrc orc comc out of ils bllpl;illlul silc.
In 3ddilion, tllc nccd rOr tcmpor;lry :Inlirn~ inn 1l ~n~ d witl commcrci31 ~nnlll,nrl~ty rin~s is probably um~ y wiLII Lhc prcscnt invcntion, cspcci311y ir Lllc sc~mcntcd rpp3r3tus is covcrcd witll 3 shbilizin5 m3Lcri3l sucll 3s pcriu~ll.liu..., 3s no Lllrombo~cnic surr3ccs 3rc cxposcd Lo tllc blood cxccpt for suturc 20 I;nots SuLurc l;nots 3rc lcss lilicly to comc unLicd wllcn uscd in l,onju.,~liù
willl 3 st3bilizin~ m31cri;11 wllicll is sit~nirlc:llllly dr roml;~blc in ;~ lon~iludill;ll dircction, sucll 3s pcric3rdium, sincc indivi(lu;ll sulurcs c3n bc ticd firmly wilh uniform m3xim31 tcnsion 3S3inst tllc non-dcforlll3blc suturc support sc~mcnt witllout 25 3ny possibility cr 3ddition;l1 lroll .ill r~ I s~ortcnill~ of tllc tissuc 3mlulus duc lo cxccssivc tcnsion durin~, I;noL-Iyill~~
Whcn Illc 3pp;lr;l~us 3nd mclllod Or Illc prcscnt invcnlioll is uscd in inf3nts and f~rowinf~ cllildrcn wiLllout thc sL3bilizin~ ma~crial, Lllc po~cnti~l for ~rowLII Or 3 v3scul3r struclurc or c;lrdi3c v;llvc ;umulus bctwccn tllc suLurc support 30 scsmcnts is rctaincd Whcll uscd to pcrform 3 . u~ s~,~u ~ n~llor~ y of a scmilunar valvc, as sllown in ~i~urcs lû and 11, and tllc suLurc support sc~mcnts arc vcrtically oricnLcd witllin ll~c sinus on ciLllcr sidc of Lllc UUllUlli~UIC just sl~ort of tl~c lcaflct -lû-SU BSTITUTE SHEET (RULE 26~ /

WO 9C/04852 2 1 9 7 0 ~ 9 r~ 9 llin~c no rcduction in Icallct l~ci~hL occurs wllcll ~llc suturc is ~icd. Sucll Icallct bcif~ht rcducLion at tllc uu~ u -~ could occur il Lllc buttrcssillf- m;ltcrial wcrc dcformablc (c.~ cnon rcl~ plc~l~c~).
A ~stabilizhl~ ;umulol71;lsty Or Lllc aorLic v;llYc amlulus could bc S ~rrmnrlicllr~l in opcrations wllcrcill ;I dilatc(.l aortic root is rcplilccd with ;I dacron conduit and Lllc ;lortic valYc is sparcd ~c.~. Y acoub ;md D;lvid) p;lr~icularly if tllc conduit is uscd to crcatc pscudo-sinuscs and docs not cn~f7c tllc ;Ictual ;lortic Yalvc annulus witll suturcs (ri -urcs 1~ 13). In such cascs tllc suturc support sq~mcnts could bc pl~ccd 011 ~llc cn~foc;lrdi;ll Sul~r;lCC or ~llc Icr~ vcn~ricular ou~ffow 10 tr~c~ in a sill~lc horlzoll~;ll pl;ulc imlllcdi;l~cly bclow ~llc lowcs~ poin~s or ~llc sc;lllopcd ;lor~ic v;llvc shluscs ;Ivoi(Jilll COn~;lCL Willl ~hc Icallct hillf C. Thc sL;lbilizin~
mi~tcriill could Lllcn bc placcd on tllc cpic;ll-~fi;ll surl.lcc (fïcurc 14).
AlLhou~ hc prcscnL invclltioll is p;lrticul;lrly suiLcd rOr rcducin~ tllc c;rcumrcrcncc of vascular s~rucwrcs sucll as c;lrdiac v;~lvcs ;Is indicatcd 1-~ .il..b tllc ;IpparaLus ;md mctllod m;ly bc ;Ipplicd io rcducc tllc circumfcrcncc of ;my valvc vcsscl or lumcn in thc body includin~ Lllosc in tllc di~cstivc ~cnito-urill~ry circulatory or rcspiratory Sys~cllls. By ~llc mc~llod dcscribcd hcrcinabovc a plurillity oF suturc suQport sc~mcnts :Irc suLurcd ;Iround ;l ~ portion of thc circumfcrcncc oF tllc structurc for cxamplc an intcstill;ll lumcn Tllc abovc Exalllplcs iuld disclosurc ;Irc intcndcd to bc illustrativc and not cxhaustivc. Tllcsc cx~mplcs and dcscription will su~scst m;my variaLions andal~crnativcs to onc of ordin;lly sl;ill in Lllis art. ~ llcsc ~Itcrn~tivcs imd vari~tions ;Irc inLclldcd to bc includcd wiLllill Lllc scopc or Lllc atL;Icllcd cl~hlls. Thosc fimliliar ~vith thc art m;ly rcco~nizc othcr cquivalcnts to Lllc spcciFlc ~ I ho 18~ dcscribcd hcrcin ~YhiCIl cquivalcn~s arc also in~cll(lul ~o bc 1 ~ f by thc claims ;n~.lcllcd hcrcto.

Sll~STITUTE SHEET (RULE 26)

Claims (33)

What is claimed is as follows:
1. An apparatus for reducing the circumference of an anatomical structure, theapparatus comprising in combination a plurality or discrete suture support segments and a plurality of sutures, each suture support segment being made of a biocompatible, inert material and comprising an upper surface, a lower surface, opposite sides, a proximal end, a distal end and at least two suture holes extending from the upper surface to the lower surface thereof, said suture holes being spaced a predetermined distance (D) apart, and wherein each suture support segment is individually sutured with one of the plurality or sutures to a length (D') of tissue of the anatomical structure whose circumference is to be reduced, by effecting a horizontal mattress (U-shaped) suture such that the length (D') of tissue sutured is greater than the distance (D), each sutured suture support segment creating an imbrication in the anatomical structure when each suture is tightened and tied off, reducing the circumference of the anatomical structure by an amount corresponding to (D') - (D), whereby the anatomical structure is permanently reconstructed to a normal configuration.
2. A method of reducing the circumference of a vascular structure having an upper portion and a lower portion, said upper and lower portions of the vascularstructure defining an upper circumference and a lower circumference of said vascular structure, said method comprising the steps of:
a) providing a plurality or discrete suture support segments of a biocompatible inert material, each suture support segment further comprising an upper surface, a lower surface, opposite sides, a proximal end, a distal end and at least two suture holes extending from the upper surface to the lower surface thereof and being spaced a predetermined distance (D) apart;
b) providing a plurality of sutures with a first end and a second end and at least one surgical needle attached to an end thereof;
c) individually suturing each said suture support segment to the vascular structure whose circumference is to be reduced by using one of the plurality of sutures to effect a horizontal mattress (U-shaped) suture along a length of tissue of the vascular structure defined by an entry point and an exit point of said suture in the vascular structure such that the length (D') or tissue sutured is greater than distance (D);
d) tightening the mattress suture; and c) tying off the suture such that a suture knot is formed which sits on the upper surface of the suture support segment between two suture holes, whereby each sutured suture support segment creates an imbrication in the vascular structure thereby reducing the circumference thereof by an amount corresponding to (D') - (D).
3. The method of claim 2 comprising the further steps of:
c) providing a biocompatible, inert stabilizing material of predetermined dimensions sufficient to cover the suture support segments sutured to the vascular structure, said stabilizing material having an upper surface and a lower surface;
f) securing the stabilizing material over the plurality of suture support segments and the vascular structure, whereby the interval between the sutured suture support segments is stabilized and direct exposure of the sutured suture support segments to blood is eliminated.
4. The method of claim 3 wherein the stabilizing material is secured over the plurality of suture support segments and the vascular structure by suturing the stabilizing material over the suture support segments and the vascular structure after tightening the suture but prior to tying the suture off.
5. The method of claim 3 wherein the mattress suture is performed comprising the following steps:
a) passing the suture through the stabilizing material from an entry point in the upper surface thereof through the lower surface thereof;
b) passing the suture through a suture hole in the suture support segment;
c) suturing the length of tissue or the vascular structure between the entry and exit points;

d) passing the suture through a second suture hole in the suture support segment;
c) passing the suture through the stabilizing material from the lower surface thereof and out an exit point in the upper surface thereof;
f) tightening the mattress suture; and g) tying off the suture such that a suture knot is formed which sits on the upper surface of the stabilizing material.
6. The method of claim 2 wherein at least one suture support segment is sutured to the lower portion or the vascular structure, whereby the lower circumference of the vascular structure is reduced.
7. The method of claim 2 wherein a plurality of suture support segments are sutured around the upper circumference and lower circumference or the vascular structure, whereby the entire circumference of the vascular structure is reduced.
8. The method of claim 2 wherein each suture support segment has two suture holes spaced a predetermined distance apart, one near the proximal and and one near the distal end thereof.
9. The method of claim 2 wherein the suture holes of each suture support segment arc smooth and of a diameter which accommodates a 2-0 suture and a swedged-on suture needle.
10. The method of claim 3 wherein the stabilizing material is fabric.
11. The method of claim 10 wherein the fabric is dacron.
12. The method of claim 3 wherein the stabilizing material is a layer of tissue.
13. The method of claim 12 wherein the tissue is autologous, homologous or heterologous pericardium, whether untreated or treated with a tanning agent such as glutaraldehyde or cryopreserved or altered substantially in any similar fashion.
14. The method of claim 2 wherein each suture support segment is about 5mm in length and has a width of about 2 - 4 mm.
15. The method of claim 14 wherein each suture support segment has a thickness of at least about 1mm.
16. The method of claim 2 wherein each suture support segment has a spatulated shape.
17. The method of claim 2 wherein the vascular structure is cardiac valve annulus.
18. The method of claim 2 wherein the vascular structure is a mitral valve.
19. The method of claim 2 wherein the vascular structure is a tricuspid valve.
20. The method of claim 2 wherein the vascular structure is an aortic valve.
21. The method of claim 2 wherein the vascular structure is a pulmonic valve.
22. A method of reducing the circumference or an anatomical structure, said method comprising the steps of:
a) providing plurality of discrete suture support segments of a biocompatible inert material, each suture support segment further comprising an upper surface, a lower surface, opposite sides, a proximal end, a distal end and at least two suture holes extending from the upper surface to the lower surface thereof and being spaced a predetermined distance (D) apart;
b) providing a plurality of sutures;
c) individually suturing each said suture support segment to the anatomical structure whose circumference is to be reduced by using one of the plurality of sutures to effect a horizontal mattress (U-shaped) suture along a length of tissue of the anatomical structure defined by an entry and an exit of said suture such that the length (D') of tissue sutured is greater than distance (D); and d) tightening and tying off the suture such that the suture knot is formed which sits on the upper surface of the suture support segment between twosuture holes, whereby each sutured suture support segment creates an imbrication in the anatomical structure thereby reducing the circumference thereof by an amount corresponding to (D') - (D).
23. An apparatus for reducing the circumference of a vascular structure, the apparatus comprising in combination a plurality or discrete suture support segments and a plurality or sutures, each suture support segment being made of a biocompatible, inert material and comprising an upper surface, a lower surface, opposite sides a proximal end, a distal end and at least two suture holes extending from the upper surface to the lower surface thereof, said suture holes being spaced a predetermined distance (D) apart, and wherein each suture support segment is individually sutured with one of the plurality or sutures to a length (D') of tissue of the vascular structure whose circumference is to be reduced, by effecting a horizontal mattress (U-shaped) suture such that the length (D') of tissue sutured is greater than the distance (D), each sutured suture support segment creating an imbrication in the vascular structure when each suture is tightened and tied off, reducing the circumference of the vascular structure by an amount corresponding to (D') - (D), whereby the vascular structure is permanently reconstructed to a normal configuration.
24. The apparatus of claim 23 wherein each suture support segment has two suture holes spaced a predetermined distance apart, one near the proximal end and one near the distal end.
25. The apparatus of claim 23 wherein the suture holes of each suture support segments are smooth and of a diameter which accommodates a 2-0 suture and a swedged-on suture needle.
26. The apparatus of claim 23 wherein each suture support segment is about 5mm in length and has a width of about 2 - 4 mm.
27. The apparatus of claim 26 wherein each suture support segment has a thickness of at least about 1mm.
28. The apparatus of claim 23 wherein each suture support segment has a spatulated shape.
29. The apparatus of claim 23 wherein the vascular structure is a cardiac valveannulus.
30. The apparatus of claim 23 wherein the vascular structure is a mitral valve.
31. The apparatus of claim 23 wherein the vascular structure is a tricuspid valve.
32. The apparatus of claim 23 wherein the vascular structure is an aortic valve.
33. The apparatus of claim 23 wherein the vascular structure is a pulmonic valve.
CA002197069A 1994-08-10 1995-08-10 Apparatus for reducing circumference of vascular structure Abandoned CA2197069A1 (en)

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US08/288,124 US5593424A (en) 1994-08-10 1994-08-10 Apparatus and method for reducing and stabilizing the circumference of a vascular structure

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AU (1) AU700530B2 (en)
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EP0779793A1 (en) 1997-06-25
TW340799B (en) 1998-09-21
US5709695A (en) 1998-01-20
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US5593424A (en) 1997-01-14
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AU700530B2 (en) 1999-01-07
EP0779793B1 (en) 2003-06-18
ZA956672B (en) 1996-07-04

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