CA2102710A1 - Process and apparatus for the production of a heart valve prosthesis - Google Patents
Process and apparatus for the production of a heart valve prosthesisInfo
- Publication number
- CA2102710A1 CA2102710A1 CA002102710A CA2102710A CA2102710A1 CA 2102710 A1 CA2102710 A1 CA 2102710A1 CA 002102710 A CA002102710 A CA 002102710A CA 2102710 A CA2102710 A CA 2102710A CA 2102710 A1 CA2102710 A1 CA 2102710A1
- Authority
- CA
- Canada
- Prior art keywords
- covering
- seam
- collar
- clamping
- rings
- 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
Links
Classifications
-
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
-
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/901—Method of manufacturing prosthetic device
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Golf Clubs (AREA)
- Control Of Motors That Do Not Use Commutators (AREA)
- Electrical Discharge Machining, Electrochemical Machining, And Combined Machining (AREA)
- Ultra Sonic Daignosis Equipment (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
ABSTRACT OF THE DISCLOSURE
A heart valve prosthesis having an annular support which has, at one of its axial ends, axially projecting support arms which are distributed over the circumference and are rounded at the free end is covered with a textile covering, starting from a collar form thereof. The textile covering is elastic and at least in one direction. It is inserted into the annular support and is turned, at its projecting axial ends, over the outer surfaces of the support. The two ends are then joined to one another all around by a seam. This seam may be concealed by a collar. The invention also comprises an advantageous apparatus for covering a support with a textile covering.
A heart valve prosthesis having an annular support which has, at one of its axial ends, axially projecting support arms which are distributed over the circumference and are rounded at the free end is covered with a textile covering, starting from a collar form thereof. The textile covering is elastic and at least in one direction. It is inserted into the annular support and is turned, at its projecting axial ends, over the outer surfaces of the support. The two ends are then joined to one another all around by a seam. This seam may be concealed by a collar. The invention also comprises an advantageous apparatus for covering a support with a textile covering.
Description
WO92/19185 ~ PCT~EP92/01018 _ ~OC~SS AND AP.~RATUS ~OR TXE ~ODUC~ION OF .i ~E~
VALVE PROSln~S~S
The lnvention relates to a process ac_ording to the precharac~e~ising clause oî Claim 1 and to an apparatus for carrying it out.
The known prostheses used in cardiac surse contain a c~own-shaped annular element of plastic, but generally of metal or or both ma~er~als. They consis~
in general of lonc" or~en wire~ e elements wnic;~ a_e 0 predominantly not very elas:~c and are often jo-ned bv solder ng or weld-ng. This results `n poor acaptabil-~, espec ally since t.ie joints t.~en become ~r_._le, ~ut n some c_s2s a'so ~ela~-ve~y ~oo-~o~erance, no~ leas. because ~Ae t2x2Lle c~ve- nc :_ sene-_'lv appl-ed ;o ..~e 2nnulæ eiemen.~ er. -eG~ ~es seve-al sezms n or~e~ .o hoic sec-rely on -he ~i~e sk21eton of t.ie znnula- e~emen~ .he -es~ _ that s~=eng~.~ probiems mav also oc- - anc manu~2c-~re s m2de more d --ic-~l;. mV~iC2l he~-= valve DroS..~eSeS o_ 20t.~-s .~?e are des~- bed n U.a. ?at n~ 3,5,0,01' o-U.S. ?a~2nt 3" ~_,8~3.
_~ s ;.ie obJec~ of ~he nve~t-on .~ des cn 2 iea - vzlve ?ros.;~es_s o. .ie ~~ce s.ated a~ e ou.sa_ ' n 5UC;~ a W2V ;n2~ e 2d2Dt~Di -ty and :~le_ancs a-e m?r~ved, s.-enc-~. ?_oolems ~e-ns 2voide~. m~.~ S ' S
zc;~ieved ac^or-inc .~ e nven. on _v .:~e ~-a-2c_e_ sinc -ea.~=es o- C'~m 3v mear.s o- the ?rocess- ac-or_inc .o ; e _rlvent-on, ~he ~ex._le cove~ ns is maun.~ on .ne 30annul2_ elemen ~ a minimum o- seams. ~hus, on tne one hand, ;~e tole_2nce imoroves since a 21ur~1-ty o_ ~3iCX seams is avoided bu~ e s~-eng-~ s alsc mDroved as a -esul_, since seams alw2ys en-2 _ 2 mechanical ris'-. 1; would of c~urse also be DOSS ~ bLe 3c~O applY t~e ~rocess ac~~rdin5 ;o t;~e invent on ;~
~onvent-onal annu 2- element,, but i_ s ~rec sely n SUBSTITUTE SHEET
.WO92~19185 21~ 2 ~ ~ ~ PCT/EP92/01018 ~, combination with suc.~ a supoor which results in an optimum which hzs a form according to a simultaneously submitted paten~ application and is shown he~e.
Although the process ac_ording to the invention could also be realised without an apparatus of a particular type, the apparatus according to the invention according to Claim 6 not only considerably helps and facilitates the implementation of the process and the produc_ion of a prosthesis according to the !0 invention but also suarantees uniform qual~ty through the clamping apparatus provided acc~rding to the invention.
rurther details of he invention are evident f-om the folLowing desc- ?~_on of emDodiments shown !5 schematically in the drawins.
F~g. 1 sh~ws a hear- valve ~ros-hesls ac-or~lna ~o t~e ~nvention before a~-achment o, the biologic~
hear~ vzLve ma~2r~a1;
~is. 2 to o show the suc_essive steos in car-ying out the process ac~or~ing to ;he ~nvention, sta_~Lng f_om a rec_zngul2r 2iece o~ mater~al according to F~s. ~; and -~g. ~ shows ar. ap~a_2tus ac^ord~nc .o ~ne ~nvent on for C2; ~ving our t.~s process.
F~g. 1 shows an oblique view of a hear~ valve prosthesis l ac_~rd ns to t:~e nvent on wi.h ?ar~lv removed textile cove_ ng 3, wAich covers an annular supoor. la t~gerhe- wi~;~ a c~ila- 2 at~ached the~e~o.
As can be seen, the annula~ eiemen_ la consis.â of ~la.
mzte_Lal, in par~iculæ- o~~ a the~mopl2stic, so that can be produced easi v and economic lly, for example by injec:ion moulding.
The support la possesses, in a manne- known pe-se, three axially projec~ing suppor~ a=~s ~, tAe f-ee ends of which are ,ounded. P-ojections ~ and indentations 6 are ar-anged alte~nately on the axizl end, the base B/ OI this support la, whic;~ end is SUBSTITUTE SHEET
WO52/19185 21~ 2 ~ ~ ~ PCT/EP92/0t~18 _ 3 cpposite the Support arms 4, it being possible for any excPss bioLo~ic21 heart ~alve material which is to be flat~ened in a conventional manner over the support arms and is to be fastened to the collar 2 to be accommadated in said indentations.
The textile covering 3 is elastic and consists expediently of a netwcrX fabric, because such a fa~ric has sufficient intrinsic elasticity - even when conventional, biologically tolerated textile mate-ial is used. In practice, a USCI product, AdaYison, from C.R. Bard, Catal~gue No. 007831, has proved expedient.
This is all the mare surprising since nonelastic c~ve_ ngs have been chosen to date; however, it will subseauently bec~me clear that the choice ot elast c mate-ial results ~n a simolification in the manufac~ure oî ~he heart ~alve prosthesis, improved safet~ wi~h -eSDeC= tO .ear~ng or seams and a smaller numbe- o~
suc~. seams, wnich also improves the tolerance ot the _rost.hesis. This is because in many cases a c~ncealed (an~ therefore ~nvisible) c -c-lmrerent-al seam ln t~e regi~n or the c~lla- 2 wil! be surficient, if necessa~
Wi ~h 2 vertical seam 7.
In order to facll ta~e the process ac^orAing to the invention - with optimal anatomical fit - t is ~5 expe~ient if the supoor~ a~ns 1 are rounded at ;hei-'-ee ends with t,~e -adius ~ wnic~ cor~esponds to no~
more thzn one elshth of the diamete_ of the suppor-. lz ln ~~e ,esion of its c~llar 2. On the othe_ hand, lt ~s advantageous 1-- the lndentat ons 5 are relat~velv iO flat, the radius o~ cur~ature 2R preIe-abiy cor-esponding to not more than twice the radius o, c-1rvature R of the supoort arms 4. The collar 2 sAown in Fig. 1 and consisting of ;extile or plastic material is expediently mounted between two circumrerenti 2 lines, or whic~ the upper circumrerential line is prefe_ably lacated a distance al' of about 1 mm below the base 4a of the suppor_ arms 4 but the lowe-:
SUBSTIT~JTE SHEET
. WO92/19185 21~ 2 ~ ~ ~ PCT/EP92/01018 ci_cumrerential line is ad~antageously slightly fur-~he-away from the edges of the indentations 6, so that a distance a2' ~f, for ex,~mple, 2 mm results.
In this context, it is thererore possible firs~
to prefabricate annular elemen~s la of different dia~eters, preferably .rom 17 mm to 33 mm at the base B. In order therearter to form a hear-~ valve prosthesis shown in Fig. 1 theref-om, it is neoessary ~o pro~ide - in the manner desc_ibed, a textile covering 3, which state had to be produced f~om several indi~idual parts, tediously and with several seams. It is therefore intended, with reference to Fig. 2 ;o 6, to desc_ be the process ac-ording to the invent'on, in which, s.ar~ing ~~om a piece or materi2! closed ~ 2 collar-like manner, a single seam is sufficient.
Acc~rding to Fig. 2, ;~oweve-, d pre?arec.
~extile collar is na. avail2Dle and muso C_-s b be ?roduced --om a _ec~angula_ ?iece or mat~_-al i~ ~he manne_ shown. This ~iece or ma~e_ial consisrs or a net-~or~ ab~ c, fcr example a knitted fabr c, naving a sequence of relatively dense st- ?s 12 formed '-om war~
t~reads and sparser meshes 13 in between, whic~ in par: cula- give the tex:_le cove-ing 3 eLas~ c t~ 1~
.he direc_ion of the ~--ow ~ wAereas t has s1ishrly ~5 less elasr city in _he d _ec__on at -~gAt angles .he-eto. A s mila- ma~e__al has been ou~ on the mark20 by USCI, Adavison, f-om C.~. Barc, US~, under C~talogue No. 007831.
Whereas to date nonelast c cove- ~gs we-e used in spite of the large numbe- o. seams _equired, ~he elasticl~_y of the text le cover ~ 3 used ac-~rdina ~o the in~ention allows the lat~er ~o be oulled over the suppor~ arms 4 and thei~ base region aa, di.~erences in length being elastically compensated. Of course, the covering 3 consists of medically or biologically tolerated textile material known pe_ se. -'rhus, in orde~ to obtai~ the requi_ed cslla-:
SUBSTITUTE SHEET :~ -. wo 92/19185 ~ ~ ~ 2 ~ ~ ~ PCT/EP92/01018 ~- for~ according to Fig. 3, the rectangular piece or material according to Fig. 2 is bent with its ends towards one another, and the ends are then connec ed to one another by a vertical sea~ 7 (cf. Fig. 1). As can be seen, it is preferable if the edges 14 of the material ~re provided with a bead in order to inc_ease the strength of the seam 7. To avoid outward-projecting material residues in the covered support la, the collar with its bead on the inside according to ~is. 3 is expediently turned outwards before beLng pulled into the suppor. la.
The collar-like fabric sleeve thus for~ed is pulled througA the annular element la .-om the lnside 2c~rding to Fig. 4, so that the c0112_ 3 is coaxial lS with said annular elemen~ and the axial ends or the ;ex=ile cover~ns projec~ abo~e and below the znnular elemen~. From this explanation, ; is or cou_se o'e2_ .hat 7-is. 3 merely shows a sec~ion of the c~ll2r, whic;~
- n orde to be able .o projec_ above the SUDpOr- 12 ~0 anc ~elow the lat.er - musr have a diame~er wAich s substantially smaller ;han the lengr~ or the colla- 3.
In any case, the upDer projec_ ng end !5 oI .~e c~ve- ng 3 c~n t~us be ;urned outwards and downwa~~s .~
;:~e manner shown in r is. 4, wAereas ~he lowe-~rojec-ing end 16 s ~lr~ed out~ards 'rom the bo~:om.
Is 2 coll ar 2 (Fig. ') is to be mounted, ~ s e~edient i_ the lowe- end 16 is c~osen t~ be sl ght7y longer ~han the upper en~ 15, since it is n~ended to oe used for c~ver ng the csllar 2. _t s o- c~urse also clea- that Fig. 4 shows ~e cove-lng 3 in par.ially cut awzy view with the cent-al s;-ip omi~te~, since the colla_ 3 ac~ordlng to ~is. 3 does i~ Izc_ form a closed hollow cylinder. This sec_ on view ac~ordins to ~ig. 4 is merelv intended to ii'us~-~te the path of the two ends 15 and 16. -As soon as the two ends 15, 16 ha~e been turne~
i-.to the posit on shown in ~ig. ~, all tn2t s s.
SUBSTITUTE SHEET
' ~.:' .' . . - ' ' ': : . '' : `, .
WO92/19185 ~ ~ 2 71~ PCTtE ~ ~01018 required is a circ~mre_ent~al se2m 17 to sew together the joining points 18 of the ~wo ends l~, 16, whic~
joining points ha~e been pulled together. If the starting material used was aLready a collar-shaped fabric, for example a hollow networ~ article, the s~am 17 is the only seam required for the covering and, when a collar 2 is mounted, e~en this seam is covered by said collar. Instead of a hollow networX article, it is also possible to use hollo~ knit~ed fabric, networ.
maserial being preferred because it has int- nsic elasticity wnich is due to the method of produc~ion and is not associated with the use of an elastic material, although such a mate-ial could also be used within the scope of the inven~ on, provided it is biologically tolerated. As is evident and is confirmed in prac~ice, ;his intrinsic elas~ic-ty above all compensa~2s any di';~e-ence in length whic~, in the cas2 of the suppor~
arms A, with their bas2 area ~a in be~ween, is par.ic~larly la_ge. Ne~er~neless, there is no danger of overst~e~ching of t~e -abric 3, an~ the dLrec~ion or extension along ar-ow A' of F~g. 2 has proved in practice to be more advantageous than the :everse direction .
Once this point or tAe process has beon reached, it is st !1 necessarv to ?lace a plas. c piece or the liXe which forms a colla- 2, and has a c-oss-section which ls angular, ror example rectanguLar, but according to ~ig. 5 in this case t~iangula_, on ~he projec-ing and the shor~ enc 15. It mav be -~
advantageous to faslen the c0112_ 2 with the aid of 2 few cross stitches l9 or zig-zag stitches 20 the annular element la in orde_ to prevent sl~pping o~ --.
twisting and for this purpose small t.~rough-noles (not shown) may be made in the suppor_ la, in p2rt' cu12- in ~5 the region of the upper circ-lmre-ential line ( cf . the upper limit of the collar 2), but in any case along the lower circ~mferential line (that is to say at the lowe~
limit of the C0112_ 2 or between thes2 lLnes) n orde-SUBSTITUTE S~EET ~ ~
.,,~ , , , ~ . .
' ' ' ' '" ' ~`.
' . ' '' ','. ', ' , , ` .' . ., . ',,:, .,.','~' ' `: ' ' W092/19185 210 2 7 ~ ~ PCTtEpgztolol8 .~ ~ac litate this Connec-ion~
The lower, longer end 16 is now folded,over the uppe- surrace or the collar 2 (Fig. 6) and around the inner lateral surface of said collar in such a way that the latter is covered by a sec:ion 21 and the former bv a sec_ion 22. This is of course only necessary when the collar 2 is not itself formed from textile material or covering by the textiie covering 3 is desired for ot~e- reasons, said covering also being used for anchoring in the biological tissue. The turning ove-of :~e end section 21 ma~es it possible to conceal this end and to fasten it to the covering or, if necessary, aLso to the annula- eLement la with t~e aid ~r 2 concealed s2am 23, for wnic.h pur2ose the above-ment_oned, very smaLl through-holes ar-anged in the -ec~ion or t~e c -cumre-entia l ~es de~e~ined Dy ..he eo!~ar 2 may be used.
By apply~ng the concealec seam 23 in the _egion of ;..e previously apolied seam l/ (~ig. 4), both seams 20 2r2 c~ve-ed ~y ;he collzr ~ 'n such a way thal, on the one :nand, they are ~ir~ually comple_ely invisible r_om ;he outside or merge to for~ a single seam. ~owever, ~ s seam 23 can of course aLso heLp .o Cas~en the two end sec~ons 15, 16 (F~g. 4~, so _hat ths seam 17 m2y ~e '?. t~e form or a relatively loose ~uilting seam. I-.
_he 'inal analysis, the appear_nce or the hear~ valve ~ros.~esis 1 shown in .~is. l is then achieved.
To be aDie ;o car~v ou~ _he process desc~~be~
aDove in a simci __ec manne~, _ s pref~r~ble _o ?rovide an appara~s accor~ing .o -~g. 7. ~is has essent~ally .wo rings 33, 3~, .he nte-n2l dlamete- o-whic;~ is sur.iciently large _o hold a complet-prosthesis l, that is to say a pros.~esis l formed f=om sup~or_ la and tex~ le cover~na '. A ce--~a n additional play between .he outer diameter of the annular element la reinforced with the cove-ing 3 and .he ~nter~al diamete_ of the -ings 33, 3~ makes SUBSTITUTE SHEET
,.'.'.;'',.'.' ' ' '' ~ ~ ' ~, W092/t9185 ~ 1 ~ 2 ~ ~ 9 PCT/EP92/0l0l8 ?ossible to apply an all--ound seam at a point 24 within the inte~nal diamete_ or the ,ings 33, 34, 25 will be explained below.
First, however, the annular element la, wit;.
c~llar 3 inserted through from the nside, is ?laczd Ln the inner opening 25 of the -ings 33, ~4. Thereafter, the lower end 16 is then expediently .urned out-~ards over the outer surface or the annular element la and is -as;ened carefully to the lowe- -ing 33 so that i' _est with its end sec~ion 21', in each case wit~ ~he same length over the entire circumference, on a su~por_ sur-ace 26 of the ring 33. In this position, the lower end 16 ls detachabLy -xed, for example wit~ ~he aid ~.
a clamping r~ns 28. This clampins - ng can be ~ ne c -orm of a s?ring ring or in the form or a c _~~mrerentLal ~~ng which can ~e clamDed, for examole, .he ai~ or a toggle lever apparatus (no~ shown), _:~e f rs; embocLment belng pre~e_-ed. In order .
e~large the clamDing a_ea, i. s advantage~us i- ~;~e ng 33 has a circlm_eren~ al seam 27 inc!ucing ;.~e ~ing 26 together with the ?iece or 'æbric clamped by t.
A'~er ~:~e lower en~ i6 nas ~een ~as~ened to ;:~e owe- ring 33 Ln this manne- he upper end can be _~ ~ulLed over t~.e suppor~ a~s ' and .~e -2cions 'z ?resent in between. The uoDe_ enc 15 is then .as.e".~
t3 .he clampins app2ra~uses 29, ~n c:~ for .~is pur?ose are e~uLDped w~lh gr ppinc eiements ' , _cr 2~amDle w~th hooks (as snown), bu_ _ ~ecessa~y zls~
.orceps-like gr ppers. These g, ?ping elements 'l are connected to tension elements, suc;l as spr ncs 30, anc are subjec~ed '~ a load bv these, i. beins advant~geous if the spring rorce is ad~us.able with the zid o- ar.
adjusting sc_ew ~O in order .o be abie to adapt _ - 35 dif~rent prosthesis sizes. On the- othe- hanc, adaDtation mav also be necessa y when ciL e~en~
ccverings are used, since t ~i ' generallv ~e SUBSTITUTE SHEET ::
., , ~
WOg2/19185 ~ 1 ~ 2 7 10 PCT/EP92/01018 nec~ssary also to change the r~ngs 33, 34 wnen the size of the prostheses l is changsd, unless the diameter is adjus~ed by inser.ing a suitaDle sleeve into each or the rings 33, 34, which is also passible within the S scope of the invention Furthermore, the section through the r ngs 33, 34 shows that the inner surfaces thereof are preferably inclined towards the clamping point at which the ends 15, 16 meet one another, in order to improve the accessibility during sewing To return to the clamDing apparatuses 2~, it may be mentioned that it is advantageous if the par-.icular clamping force set can be _ead on a scale 42 connec~ed to the adjust ng sc=ew ~0 In order ~o dis.-ibute the clamping force 2S
uni'ormly as possible over the cir~umrerence of the ~ing 34, a plurality or clamDing apparatuses 2q, which are nd cated me_ely bv their axes 29', is expedien~ly dis._ibuted over the c rc~mference of this - ng In orde_ to suppor~ these clamoing apparatuses 2c on the ou~side of the r ng 34, .he lat.er consis.s ol an inner r ng section 35 and an outer ring section 36 on wnich the clamping apparatuses 29 are fastened This rPsults in 2 cavity 31 between the two ring sections ~5, 36, in which ca~ity, as shown, the gripping elements 41 are '5 housed of course, ~ 5 ' merely illus~-a~es a preIer-ed embodiment and t would be quite poss,ble to modi_y the ~ing 34 so that t~e gripping means 4l are also readily ac^2ssible wnen ~lngs 33, 34 are piaced together, in which case it would also be po~sible to apoly the seam 17 (c. Fig 4) not inside the opening 25 but instead just on the outside oI the inner ~ ng section 35, in other words where the cavitv 31 is located in Fig 7 However, this reouires that, a~e-the rings 33, 34 have been slac~ened, the texti7e c~vering is placed around the annular element la under less tension than when the seam is applied, ln othe-SUBSTITUTE SHEET
WO 9A~19185 ~ PCTtEP92/01018 w~rds the faoric would have to be more greatly st-etched during sewing, which on the one hand would maXe measurement of the clamDing force with the aid of the clamping apparatuses more dif~icult (where these can be provided at all) and on the other hand would give rise to the danger of o~erextension of the textile coYering 3 An apparatus as shown in Fig. 7 could also be used for applying a different type of seam connec~ion if, for example, one of the two rings 33, ~4 or both rings 33, 34 are equipped with a heataole ring region, th~s permltting heat bondlng or welding of the two fabric ends 15, 16. Howe~er, a weld seam or bonded seam, the produc~ion or which is generally simple-, is l. generally thic~er and especially less elastic than a sewn seam, which is therefore preferable for hear=
prosthes2s of this type.
In order to hold the -ings 33, 3~ securely du-ing the operations desc-~oed above, it is axDedien~
to provide a stand 51 which - for holding the suppor~
la at the desired wor~ing height - is advantageously pro~ided with a retaining bush 32 which is adjusza~le in he~ght and can be sc~ewed to various depths into the stand 51.
~he rings 33, 34, which are held ln .he indicated clamping position by cor~esponding clampins means, such as clamping sc_ews ~4 or clamDs, dur~ng ap~lication of ~he se~m 17 (F~g. ~), are expediently guided on the stand 51 wlth ;he aid-of guide columns i7 but can be secured on the latter in the position lowered towards the retaining bush 32 with the aid or-adjusting rings 43 which can be moved along ~ne columns 37 and clamped to said columns or with the aid of other blocking elements. After appLication of the seam l, inside the opening 2S, the colla- 2 can be mounted according to Fig. 5, afte- which the projecting end 15 is cut off.
... ,. . , . .................... , - .. . . .
, ., , ~ , . . . . .
. ~ WO 92/19~85 ~ 7 ~ ~ PCT/EP~01~18 ,.
In prac~ice, either a human (if desired also animal) puLmonaxy or aortic ~alve is stared i~ a nut_ient solution (together with antibiotics and other subs~ances) and is sewn to the prosthesis desc~ibed shortly before use, or the already assembled co~ponents of the prosthesis are stored or frozen ~ogether in a nut-ient solution until they are required. This.also enables a high cell survival rate to be achieved, and the prostheses produced in this manner can be used in fou_ different positions.
It should be mentioned that the positioning _ings 43 constitute an additional element for holding the - ngs in the Lower position in the~- mutual cLamping position and thus, if necessary, facilitat'ng subseauent pulli~g or the co~ering 3. Only when the ,aDric has been pulled uniformly o~er the annula-element la and the meshes ~m s~_aight along the generat__ces of ~he sllght1y conical ring la is it ex?edient to ef-ec- t.~e inal clamoing by means of the sc-~s ~4.
~ large nu~oer of modi_ications are possible wi~.in the scope of the in~ention; thus, the func_ on of _he r ngs 33, 34 could be interchang~d with one ano~ne- by, for example, pro~iding the fastening 27, 28 on ~he upper ring 34 and ;~e clamping apparatus 29 on t~e lower ring.
~ . . . . ................... . ....... . . .
`-, ~ . ,: ` . ' : ' . :: ' : '
VALVE PROSln~S~S
The lnvention relates to a process ac_ording to the precharac~e~ising clause oî Claim 1 and to an apparatus for carrying it out.
The known prostheses used in cardiac surse contain a c~own-shaped annular element of plastic, but generally of metal or or both ma~er~als. They consis~
in general of lonc" or~en wire~ e elements wnic;~ a_e 0 predominantly not very elas:~c and are often jo-ned bv solder ng or weld-ng. This results `n poor acaptabil-~, espec ally since t.ie joints t.~en become ~r_._le, ~ut n some c_s2s a'so ~ela~-ve~y ~oo-~o~erance, no~ leas. because ~Ae t2x2Lle c~ve- nc :_ sene-_'lv appl-ed ;o ..~e 2nnulæ eiemen.~ er. -eG~ ~es seve-al sezms n or~e~ .o hoic sec-rely on -he ~i~e sk21eton of t.ie znnula- e~emen~ .he -es~ _ that s~=eng~.~ probiems mav also oc- - anc manu~2c-~re s m2de more d --ic-~l;. mV~iC2l he~-= valve DroS..~eSeS o_ 20t.~-s .~?e are des~- bed n U.a. ?at n~ 3,5,0,01' o-U.S. ?a~2nt 3" ~_,8~3.
_~ s ;.ie obJec~ of ~he nve~t-on .~ des cn 2 iea - vzlve ?ros.;~es_s o. .ie ~~ce s.ated a~ e ou.sa_ ' n 5UC;~ a W2V ;n2~ e 2d2Dt~Di -ty and :~le_ancs a-e m?r~ved, s.-enc-~. ?_oolems ~e-ns 2voide~. m~.~ S ' S
zc;~ieved ac^or-inc .~ e nven. on _v .:~e ~-a-2c_e_ sinc -ea.~=es o- C'~m 3v mear.s o- the ?rocess- ac-or_inc .o ; e _rlvent-on, ~he ~ex._le cove~ ns is maun.~ on .ne 30annul2_ elemen ~ a minimum o- seams. ~hus, on tne one hand, ;~e tole_2nce imoroves since a 21ur~1-ty o_ ~3iCX seams is avoided bu~ e s~-eng-~ s alsc mDroved as a -esul_, since seams alw2ys en-2 _ 2 mechanical ris'-. 1; would of c~urse also be DOSS ~ bLe 3c~O applY t~e ~rocess ac~~rdin5 ;o t;~e invent on ;~
~onvent-onal annu 2- element,, but i_ s ~rec sely n SUBSTITUTE SHEET
.WO92~19185 21~ 2 ~ ~ ~ PCT/EP92/01018 ~, combination with suc.~ a supoor which results in an optimum which hzs a form according to a simultaneously submitted paten~ application and is shown he~e.
Although the process ac_ording to the invention could also be realised without an apparatus of a particular type, the apparatus according to the invention according to Claim 6 not only considerably helps and facilitates the implementation of the process and the produc_ion of a prosthesis according to the !0 invention but also suarantees uniform qual~ty through the clamping apparatus provided acc~rding to the invention.
rurther details of he invention are evident f-om the folLowing desc- ?~_on of emDodiments shown !5 schematically in the drawins.
F~g. 1 sh~ws a hear- valve ~ros-hesls ac-or~lna ~o t~e ~nvention before a~-achment o, the biologic~
hear~ vzLve ma~2r~a1;
~is. 2 to o show the suc_essive steos in car-ying out the process ac~or~ing to ;he ~nvention, sta_~Lng f_om a rec_zngul2r 2iece o~ mater~al according to F~s. ~; and -~g. ~ shows ar. ap~a_2tus ac^ord~nc .o ~ne ~nvent on for C2; ~ving our t.~s process.
F~g. 1 shows an oblique view of a hear~ valve prosthesis l ac_~rd ns to t:~e nvent on wi.h ?ar~lv removed textile cove_ ng 3, wAich covers an annular supoor. la t~gerhe- wi~;~ a c~ila- 2 at~ached the~e~o.
As can be seen, the annula~ eiemen_ la consis.â of ~la.
mzte_Lal, in par~iculæ- o~~ a the~mopl2stic, so that can be produced easi v and economic lly, for example by injec:ion moulding.
The support la possesses, in a manne- known pe-se, three axially projec~ing suppor~ a=~s ~, tAe f-ee ends of which are ,ounded. P-ojections ~ and indentations 6 are ar-anged alte~nately on the axizl end, the base B/ OI this support la, whic;~ end is SUBSTITUTE SHEET
WO52/19185 21~ 2 ~ ~ ~ PCT/EP92/0t~18 _ 3 cpposite the Support arms 4, it being possible for any excPss bioLo~ic21 heart ~alve material which is to be flat~ened in a conventional manner over the support arms and is to be fastened to the collar 2 to be accommadated in said indentations.
The textile covering 3 is elastic and consists expediently of a netwcrX fabric, because such a fa~ric has sufficient intrinsic elasticity - even when conventional, biologically tolerated textile mate-ial is used. In practice, a USCI product, AdaYison, from C.R. Bard, Catal~gue No. 007831, has proved expedient.
This is all the mare surprising since nonelastic c~ve_ ngs have been chosen to date; however, it will subseauently bec~me clear that the choice ot elast c mate-ial results ~n a simolification in the manufac~ure oî ~he heart ~alve prosthesis, improved safet~ wi~h -eSDeC= tO .ear~ng or seams and a smaller numbe- o~
suc~. seams, wnich also improves the tolerance ot the _rost.hesis. This is because in many cases a c~ncealed (an~ therefore ~nvisible) c -c-lmrerent-al seam ln t~e regi~n or the c~lla- 2 wil! be surficient, if necessa~
Wi ~h 2 vertical seam 7.
In order to facll ta~e the process ac^orAing to the invention - with optimal anatomical fit - t is ~5 expe~ient if the supoor~ a~ns 1 are rounded at ;hei-'-ee ends with t,~e -adius ~ wnic~ cor~esponds to no~
more thzn one elshth of the diamete_ of the suppor-. lz ln ~~e ,esion of its c~llar 2. On the othe_ hand, lt ~s advantageous 1-- the lndentat ons 5 are relat~velv iO flat, the radius o~ cur~ature 2R preIe-abiy cor-esponding to not more than twice the radius o, c-1rvature R of the supoort arms 4. The collar 2 sAown in Fig. 1 and consisting of ;extile or plastic material is expediently mounted between two circumrerenti 2 lines, or whic~ the upper circumrerential line is prefe_ably lacated a distance al' of about 1 mm below the base 4a of the suppor_ arms 4 but the lowe-:
SUBSTIT~JTE SHEET
. WO92/19185 21~ 2 ~ ~ ~ PCT/EP92/01018 ci_cumrerential line is ad~antageously slightly fur-~he-away from the edges of the indentations 6, so that a distance a2' ~f, for ex,~mple, 2 mm results.
In this context, it is thererore possible firs~
to prefabricate annular elemen~s la of different dia~eters, preferably .rom 17 mm to 33 mm at the base B. In order therearter to form a hear-~ valve prosthesis shown in Fig. 1 theref-om, it is neoessary ~o pro~ide - in the manner desc_ibed, a textile covering 3, which state had to be produced f~om several indi~idual parts, tediously and with several seams. It is therefore intended, with reference to Fig. 2 ;o 6, to desc_ be the process ac-ording to the invent'on, in which, s.ar~ing ~~om a piece or materi2! closed ~ 2 collar-like manner, a single seam is sufficient.
Acc~rding to Fig. 2, ;~oweve-, d pre?arec.
~extile collar is na. avail2Dle and muso C_-s b be ?roduced --om a _ec~angula_ ?iece or mat~_-al i~ ~he manne_ shown. This ~iece or ma~e_ial consisrs or a net-~or~ ab~ c, fcr example a knitted fabr c, naving a sequence of relatively dense st- ?s 12 formed '-om war~
t~reads and sparser meshes 13 in between, whic~ in par: cula- give the tex:_le cove-ing 3 eLas~ c t~ 1~
.he direc_ion of the ~--ow ~ wAereas t has s1ishrly ~5 less elasr city in _he d _ec__on at -~gAt angles .he-eto. A s mila- ma~e__al has been ou~ on the mark20 by USCI, Adavison, f-om C.~. Barc, US~, under C~talogue No. 007831.
Whereas to date nonelast c cove- ~gs we-e used in spite of the large numbe- o. seams _equired, ~he elasticl~_y of the text le cover ~ 3 used ac-~rdina ~o the in~ention allows the lat~er ~o be oulled over the suppor~ arms 4 and thei~ base region aa, di.~erences in length being elastically compensated. Of course, the covering 3 consists of medically or biologically tolerated textile material known pe_ se. -'rhus, in orde~ to obtai~ the requi_ed cslla-:
SUBSTITUTE SHEET :~ -. wo 92/19185 ~ ~ ~ 2 ~ ~ ~ PCT/EP92/01018 ~- for~ according to Fig. 3, the rectangular piece or material according to Fig. 2 is bent with its ends towards one another, and the ends are then connec ed to one another by a vertical sea~ 7 (cf. Fig. 1). As can be seen, it is preferable if the edges 14 of the material ~re provided with a bead in order to inc_ease the strength of the seam 7. To avoid outward-projecting material residues in the covered support la, the collar with its bead on the inside according to ~is. 3 is expediently turned outwards before beLng pulled into the suppor. la.
The collar-like fabric sleeve thus for~ed is pulled througA the annular element la .-om the lnside 2c~rding to Fig. 4, so that the c0112_ 3 is coaxial lS with said annular elemen~ and the axial ends or the ;ex=ile cover~ns projec~ abo~e and below the znnular elemen~. From this explanation, ; is or cou_se o'e2_ .hat 7-is. 3 merely shows a sec~ion of the c~ll2r, whic;~
- n orde to be able .o projec_ above the SUDpOr- 12 ~0 anc ~elow the lat.er - musr have a diame~er wAich s substantially smaller ;han the lengr~ or the colla- 3.
In any case, the upDer projec_ ng end !5 oI .~e c~ve- ng 3 c~n t~us be ;urned outwards and downwa~~s .~
;:~e manner shown in r is. 4, wAereas ~he lowe-~rojec-ing end 16 s ~lr~ed out~ards 'rom the bo~:om.
Is 2 coll ar 2 (Fig. ') is to be mounted, ~ s e~edient i_ the lowe- end 16 is c~osen t~ be sl ght7y longer ~han the upper en~ 15, since it is n~ended to oe used for c~ver ng the csllar 2. _t s o- c~urse also clea- that Fig. 4 shows ~e cove-lng 3 in par.ially cut awzy view with the cent-al s;-ip omi~te~, since the colla_ 3 ac~ordlng to ~is. 3 does i~ Izc_ form a closed hollow cylinder. This sec_ on view ac~ordins to ~ig. 4 is merelv intended to ii'us~-~te the path of the two ends 15 and 16. -As soon as the two ends 15, 16 ha~e been turne~
i-.to the posit on shown in ~ig. ~, all tn2t s s.
SUBSTITUTE SHEET
' ~.:' .' . . - ' ' ': : . '' : `, .
WO92/19185 ~ ~ 2 71~ PCTtE ~ ~01018 required is a circ~mre_ent~al se2m 17 to sew together the joining points 18 of the ~wo ends l~, 16, whic~
joining points ha~e been pulled together. If the starting material used was aLready a collar-shaped fabric, for example a hollow networ~ article, the s~am 17 is the only seam required for the covering and, when a collar 2 is mounted, e~en this seam is covered by said collar. Instead of a hollow networX article, it is also possible to use hollo~ knit~ed fabric, networ.
maserial being preferred because it has int- nsic elasticity wnich is due to the method of produc~ion and is not associated with the use of an elastic material, although such a mate-ial could also be used within the scope of the inven~ on, provided it is biologically tolerated. As is evident and is confirmed in prac~ice, ;his intrinsic elas~ic-ty above all compensa~2s any di';~e-ence in length whic~, in the cas2 of the suppor~
arms A, with their bas2 area ~a in be~ween, is par.ic~larly la_ge. Ne~er~neless, there is no danger of overst~e~ching of t~e -abric 3, an~ the dLrec~ion or extension along ar-ow A' of F~g. 2 has proved in practice to be more advantageous than the :everse direction .
Once this point or tAe process has beon reached, it is st !1 necessarv to ?lace a plas. c piece or the liXe which forms a colla- 2, and has a c-oss-section which ls angular, ror example rectanguLar, but according to ~ig. 5 in this case t~iangula_, on ~he projec-ing and the shor~ enc 15. It mav be -~
advantageous to faslen the c0112_ 2 with the aid of 2 few cross stitches l9 or zig-zag stitches 20 the annular element la in orde_ to prevent sl~pping o~ --.
twisting and for this purpose small t.~rough-noles (not shown) may be made in the suppor_ la, in p2rt' cu12- in ~5 the region of the upper circ-lmre-ential line ( cf . the upper limit of the collar 2), but in any case along the lower circ~mferential line (that is to say at the lowe~
limit of the C0112_ 2 or between thes2 lLnes) n orde-SUBSTITUTE S~EET ~ ~
.,,~ , , , ~ . .
' ' ' ' '" ' ~`.
' . ' '' ','. ', ' , , ` .' . ., . ',,:, .,.','~' ' `: ' ' W092/19185 210 2 7 ~ ~ PCTtEpgztolol8 .~ ~ac litate this Connec-ion~
The lower, longer end 16 is now folded,over the uppe- surrace or the collar 2 (Fig. 6) and around the inner lateral surface of said collar in such a way that the latter is covered by a sec:ion 21 and the former bv a sec_ion 22. This is of course only necessary when the collar 2 is not itself formed from textile material or covering by the textiie covering 3 is desired for ot~e- reasons, said covering also being used for anchoring in the biological tissue. The turning ove-of :~e end section 21 ma~es it possible to conceal this end and to fasten it to the covering or, if necessary, aLso to the annula- eLement la with t~e aid ~r 2 concealed s2am 23, for wnic.h pur2ose the above-ment_oned, very smaLl through-holes ar-anged in the -ec~ion or t~e c -cumre-entia l ~es de~e~ined Dy ..he eo!~ar 2 may be used.
By apply~ng the concealec seam 23 in the _egion of ;..e previously apolied seam l/ (~ig. 4), both seams 20 2r2 c~ve-ed ~y ;he collzr ~ 'n such a way thal, on the one :nand, they are ~ir~ually comple_ely invisible r_om ;he outside or merge to for~ a single seam. ~owever, ~ s seam 23 can of course aLso heLp .o Cas~en the two end sec~ons 15, 16 (F~g. 4~, so _hat ths seam 17 m2y ~e '?. t~e form or a relatively loose ~uilting seam. I-.
_he 'inal analysis, the appear_nce or the hear~ valve ~ros.~esis 1 shown in .~is. l is then achieved.
To be aDie ;o car~v ou~ _he process desc~~be~
aDove in a simci __ec manne~, _ s pref~r~ble _o ?rovide an appara~s accor~ing .o -~g. 7. ~is has essent~ally .wo rings 33, 3~, .he nte-n2l dlamete- o-whic;~ is sur.iciently large _o hold a complet-prosthesis l, that is to say a pros.~esis l formed f=om sup~or_ la and tex~ le cover~na '. A ce--~a n additional play between .he outer diameter of the annular element la reinforced with the cove-ing 3 and .he ~nter~al diamete_ of the -ings 33, 3~ makes SUBSTITUTE SHEET
,.'.'.;'',.'.' ' ' '' ~ ~ ' ~, W092/t9185 ~ 1 ~ 2 ~ ~ 9 PCT/EP92/0l0l8 ?ossible to apply an all--ound seam at a point 24 within the inte~nal diamete_ or the ,ings 33, 34, 25 will be explained below.
First, however, the annular element la, wit;.
c~llar 3 inserted through from the nside, is ?laczd Ln the inner opening 25 of the -ings 33, ~4. Thereafter, the lower end 16 is then expediently .urned out-~ards over the outer surface or the annular element la and is -as;ened carefully to the lowe- -ing 33 so that i' _est with its end sec~ion 21', in each case wit~ ~he same length over the entire circumference, on a su~por_ sur-ace 26 of the ring 33. In this position, the lower end 16 ls detachabLy -xed, for example wit~ ~he aid ~.
a clamping r~ns 28. This clampins - ng can be ~ ne c -orm of a s?ring ring or in the form or a c _~~mrerentLal ~~ng which can ~e clamDed, for examole, .he ai~ or a toggle lever apparatus (no~ shown), _:~e f rs; embocLment belng pre~e_-ed. In order .
e~large the clamDing a_ea, i. s advantage~us i- ~;~e ng 33 has a circlm_eren~ al seam 27 inc!ucing ;.~e ~ing 26 together with the ?iece or 'æbric clamped by t.
A'~er ~:~e lower en~ i6 nas ~een ~as~ened to ;:~e owe- ring 33 Ln this manne- he upper end can be _~ ~ulLed over t~.e suppor~ a~s ' and .~e -2cions 'z ?resent in between. The uoDe_ enc 15 is then .as.e".~
t3 .he clampins app2ra~uses 29, ~n c:~ for .~is pur?ose are e~uLDped w~lh gr ppinc eiements ' , _cr 2~amDle w~th hooks (as snown), bu_ _ ~ecessa~y zls~
.orceps-like gr ppers. These g, ?ping elements 'l are connected to tension elements, suc;l as spr ncs 30, anc are subjec~ed '~ a load bv these, i. beins advant~geous if the spring rorce is ad~us.able with the zid o- ar.
adjusting sc_ew ~O in order .o be abie to adapt _ - 35 dif~rent prosthesis sizes. On the- othe- hanc, adaDtation mav also be necessa y when ciL e~en~
ccverings are used, since t ~i ' generallv ~e SUBSTITUTE SHEET ::
., , ~
WOg2/19185 ~ 1 ~ 2 7 10 PCT/EP92/01018 nec~ssary also to change the r~ngs 33, 34 wnen the size of the prostheses l is changsd, unless the diameter is adjus~ed by inser.ing a suitaDle sleeve into each or the rings 33, 34, which is also passible within the S scope of the invention Furthermore, the section through the r ngs 33, 34 shows that the inner surfaces thereof are preferably inclined towards the clamping point at which the ends 15, 16 meet one another, in order to improve the accessibility during sewing To return to the clamDing apparatuses 2~, it may be mentioned that it is advantageous if the par-.icular clamping force set can be _ead on a scale 42 connec~ed to the adjust ng sc=ew ~0 In order ~o dis.-ibute the clamping force 2S
uni'ormly as possible over the cir~umrerence of the ~ing 34, a plurality or clamDing apparatuses 2q, which are nd cated me_ely bv their axes 29', is expedien~ly dis._ibuted over the c rc~mference of this - ng In orde_ to suppor~ these clamoing apparatuses 2c on the ou~side of the r ng 34, .he lat.er consis.s ol an inner r ng section 35 and an outer ring section 36 on wnich the clamping apparatuses 29 are fastened This rPsults in 2 cavity 31 between the two ring sections ~5, 36, in which ca~ity, as shown, the gripping elements 41 are '5 housed of course, ~ 5 ' merely illus~-a~es a preIer-ed embodiment and t would be quite poss,ble to modi_y the ~ing 34 so that t~e gripping means 4l are also readily ac^2ssible wnen ~lngs 33, 34 are piaced together, in which case it would also be po~sible to apoly the seam 17 (c. Fig 4) not inside the opening 25 but instead just on the outside oI the inner ~ ng section 35, in other words where the cavitv 31 is located in Fig 7 However, this reouires that, a~e-the rings 33, 34 have been slac~ened, the texti7e c~vering is placed around the annular element la under less tension than when the seam is applied, ln othe-SUBSTITUTE SHEET
WO 9A~19185 ~ PCTtEP92/01018 w~rds the faoric would have to be more greatly st-etched during sewing, which on the one hand would maXe measurement of the clamDing force with the aid of the clamping apparatuses more dif~icult (where these can be provided at all) and on the other hand would give rise to the danger of o~erextension of the textile coYering 3 An apparatus as shown in Fig. 7 could also be used for applying a different type of seam connec~ion if, for example, one of the two rings 33, ~4 or both rings 33, 34 are equipped with a heataole ring region, th~s permltting heat bondlng or welding of the two fabric ends 15, 16. Howe~er, a weld seam or bonded seam, the produc~ion or which is generally simple-, is l. generally thic~er and especially less elastic than a sewn seam, which is therefore preferable for hear=
prosthes2s of this type.
In order to hold the -ings 33, 3~ securely du-ing the operations desc-~oed above, it is axDedien~
to provide a stand 51 which - for holding the suppor~
la at the desired wor~ing height - is advantageously pro~ided with a retaining bush 32 which is adjusza~le in he~ght and can be sc~ewed to various depths into the stand 51.
~he rings 33, 34, which are held ln .he indicated clamping position by cor~esponding clampins means, such as clamping sc_ews ~4 or clamDs, dur~ng ap~lication of ~he se~m 17 (F~g. ~), are expediently guided on the stand 51 wlth ;he aid-of guide columns i7 but can be secured on the latter in the position lowered towards the retaining bush 32 with the aid or-adjusting rings 43 which can be moved along ~ne columns 37 and clamped to said columns or with the aid of other blocking elements. After appLication of the seam l, inside the opening 2S, the colla- 2 can be mounted according to Fig. 5, afte- which the projecting end 15 is cut off.
... ,. . , . .................... , - .. . . .
, ., , ~ , . . . . .
. ~ WO 92/19~85 ~ 7 ~ ~ PCT/EP~01~18 ,.
In prac~ice, either a human (if desired also animal) puLmonaxy or aortic ~alve is stared i~ a nut_ient solution (together with antibiotics and other subs~ances) and is sewn to the prosthesis desc~ibed shortly before use, or the already assembled co~ponents of the prosthesis are stored or frozen ~ogether in a nut-ient solution until they are required. This.also enables a high cell survival rate to be achieved, and the prostheses produced in this manner can be used in fou_ different positions.
It should be mentioned that the positioning _ings 43 constitute an additional element for holding the - ngs in the Lower position in the~- mutual cLamping position and thus, if necessary, facilitat'ng subseauent pulli~g or the co~ering 3. Only when the ,aDric has been pulled uniformly o~er the annula-element la and the meshes ~m s~_aight along the generat__ces of ~he sllght1y conical ring la is it ex?edient to ef-ec- t.~e inal clamoing by means of the sc-~s ~4.
~ large nu~oer of modi_ications are possible wi~.in the scope of the in~ention; thus, the func_ on of _he r ngs 33, 34 could be interchang~d with one ano~ne- by, for example, pro~iding the fastening 27, 28 on ~he upper ring 34 and ;~e clamping apparatus 29 on t~e lower ring.
~ . . . . ................... . ....... . . .
`-, ~ . ,: ` . ' : ' . :: ' : '
Claims (11)
1. Process for covering an annular support (1a) for a heart valve prosthesis (1) which has, at one axial end, axially projecting support arms (4) which are distributed over the circumference and are rounded at the free end, having a textile covering (3), characterised in that the textile covering (3), starting from a collar shape, is elastic at least in one direction (A'), is pushed into the annular element (1a) and, at its two projecting axial ends (15, 16) is turned over the outer surface of said annular element, after which the two ends (15, 16) are joined to one another all round by a seam (17).
2. Process according to Claim 1, characterised in that the collar shape of the textile covering (3) is produced starting from an approximately rectangular piece of material, first by sewing together two opposite side of the piece of material, in particular with edges (14) having outer beads.
3. Process according to Claim 1 or 2, characterised in that the all-round seam (17) is applied at a distance (a1) of about 1 mm from the start of the support arms (4), and preferably a distance (a2) from the base (B), preferably a2 is > a1, in particular a2 is about equal to 2a1.
4. Process according to any of the preceding Claims, characterised in that the textile covering (3) used is a network material, preferably one having alternately denser strips (12) running in the axial direction of the collar and looser meshes (13), the elasticity in the direction of the strips (12) being smaller than at right angles thereto.
5. Process according to any of the preceding Claims, for a support having a collar, characterised in that the two ends (15, 16) are joined to one another in such a way that at least one of the ends (15 or 16) projects above the seam (17), whereupon a collar (2), in particular of textile or plastic material, preferably having an angular, for example triangular, cross-sectional form is mounted in the region of the seam (17) and is enveloped with the projecting end (16), the envelope expediently being sewn, preferably with a concealed seam (23).
6. Apparatus for carrying out the process according to any of Claims 1 to 4, characterised in that it has two coaxial rings (33, 34) with a central opening (25) holding the annular element (1a) together with the covering (3) of which one ring (33) is provided with a fastening means (27, 28) for one end (16) of a covering (3) and the other ring (34) is provided with a clamping apparatus (29) for the other end (15) of the covering (3).
7. Apparatus according to Claim 6, characterised in that the opening (25) of the rings (33, 34) has adequate dimensions within the opening (25) for applying the seam (17) around the inserted annular element (1a).
8. Apparatus according to Claim 6 or 7, characterised in that the clamping apparatus (29) comprises a plurality of clamping elements (29) distributed over the circumference of the ring (34), each of which is preferably provided with a gripping element (41) for the textile covering (3), for example in the form of a hook.
9. Apparatus according to any of Claims 6 to 8, characterised in that it has an adjusting and/or indicating means (40, 42) for the applied clamping force, preferably an adjustable spring (30).
10. Apparatus according to any of Claims 6 to 9, characterised in that at least one clamping means (43 or 44) is provided for holding the rings (33, 34) in a position clamping the covering (3).
11. Apparatus according to any of Claims 6 to 10, characterised in that a stand (51) is coordinated with the rings (33, 34), by means of which stand they can be held in a predetermined position, and that this stand (51) preferably has at least one of the following features:
a) it has a supporting base (32) which is adjustable in height for holding the annular element (1a) at the desired height;
b) it has a straight-line guide (37), in particular having guide columns (37), for moving the rings (33, 34) while retaining their relative positions.
a) it has a supporting base (32) which is adjustable in height for holding the annular element (1a) at the desired height;
b) it has a straight-line guide (37), in particular having guide columns (37), for moving the rings (33, 34) while retaining their relative positions.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP91107445.8 | 1991-05-08 | ||
| EP91107445 | 1991-05-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2102710A1 true CA2102710A1 (en) | 1992-11-09 |
Family
ID=8206706
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002102710A Abandoned CA2102710A1 (en) | 1991-05-08 | 1992-05-08 | Process and apparatus for the production of a heart valve prosthesis |
Country Status (25)
| Country | Link |
|---|---|
| US (2) | US5488789A (en) |
| EP (1) | EP0583316B1 (en) |
| JP (1) | JPH06507088A (en) |
| AT (1) | ATE146066T1 (en) |
| AU (1) | AU666304B2 (en) |
| BG (1) | BG61024B1 (en) |
| BR (1) | BR9205978A (en) |
| CA (1) | CA2102710A1 (en) |
| CZ (1) | CZ282122B6 (en) |
| DE (2) | DE583316T1 (en) |
| DK (1) | DK0583316T3 (en) |
| ES (1) | ES2051664T3 (en) |
| FI (1) | FI934916A (en) |
| GR (2) | GR940300033T1 (en) |
| HK (1) | HK1002696A1 (en) |
| HU (1) | HU216529B (en) |
| LV (1) | LV12036B (en) |
| NO (1) | NO300757B1 (en) |
| OA (1) | OA09822A (en) |
| PL (1) | PL167854B1 (en) |
| RO (1) | RO110595B1 (en) |
| RU (1) | RU2124874C1 (en) |
| SG (1) | SG48212A1 (en) |
| SK (1) | SK279501B6 (en) |
| WO (1) | WO1992019185A1 (en) |
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-
1992
- 1992-05-08 SG SG1996007937A patent/SG48212A1/en unknown
- 1992-05-08 ES ES92909696T patent/ES2051664T3/en not_active Expired - Lifetime
- 1992-05-08 PL PL92301321A patent/PL167854B1/en unknown
- 1992-05-08 CA CA002102710A patent/CA2102710A1/en not_active Abandoned
- 1992-05-08 JP JP4509168A patent/JPH06507088A/en active Pending
- 1992-05-08 RO RO93-01487A patent/RO110595B1/en unknown
- 1992-05-08 AT AT92909696T patent/ATE146066T1/en not_active IP Right Cessation
- 1992-05-08 US US08/146,033 patent/US5488789A/en not_active Expired - Fee Related
- 1992-05-08 EP EP92909696A patent/EP0583316B1/en not_active Expired - Lifetime
- 1992-05-08 DE DE0583316T patent/DE583316T1/en active Pending
- 1992-05-08 RU RU93058444A patent/RU2124874C1/en active
- 1992-05-08 DK DK92909696.4T patent/DK0583316T3/en active
- 1992-05-08 WO PCT/EP1992/001018 patent/WO1992019185A1/en active IP Right Grant
- 1992-05-08 CZ CS932369A patent/CZ282122B6/en not_active IP Right Cessation
- 1992-05-08 DE DE69215869T patent/DE69215869T2/en not_active Expired - Fee Related
- 1992-05-08 HU HU9303128A patent/HU216529B/en not_active IP Right Cessation
- 1992-05-08 BR BR9205978A patent/BR9205978A/en not_active Application Discontinuation
- 1992-05-08 AU AU16988/92A patent/AU666304B2/en not_active Ceased
- 1992-05-08 SK SK1229-93A patent/SK279501B6/en unknown
-
1993
- 1993-11-02 NO NO933948A patent/NO300757B1/en not_active IP Right Cessation
- 1993-11-05 BG BG98202A patent/BG61024B1/en unknown
- 1993-11-05 FI FI934916A patent/FI934916A/en unknown
- 1993-11-08 OA OA60431A patent/OA09822A/en unknown
-
1994
- 1994-05-31 GR GR940300033T patent/GR940300033T1/en unknown
-
1995
- 1995-06-02 US US08/458,257 patent/US5606928A/en not_active Expired - Fee Related
-
1997
- 1997-03-07 GR GR970400456T patent/GR3022772T3/en unknown
- 1997-12-11 LV LVP-97-254A patent/LV12036B/en unknown
-
1998
- 1998-02-27 HK HK98101566A patent/HK1002696A1/en not_active IP Right Cessation
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |