CARDIAC VALVULAR BIOPROSTHESIS AND THE PROCEEDING OF ACHIEVEMENT

Abstract: A cardiac valvular bioprosthesis is made of a biologic material (aortic valva of wild boar, bear or other animal) of a special structure which is applied on metallic support (2) or plastic material by means of connection stratum (3) of knitted textile material and the fixation on the heart is accomplished by means a ring (4) of textile material, plastic or silicone rubber. The support (2) for the bioprosthesis is made of a basis (A) and a superstructure (B). The basis (A) has a circular form with a diameter according to the diameter of the prosthesis which must be replaced and, on the circumference, presents a tube (b) of 1-2 mm, interrupted by some resistance pills (c), of which some in the middle of the flankeys (d) and the others in the middle of the curve between the two flankeys. Further is described a proceeding of achievement of cardiac valvular bioprosthetics.

Description: Cardiac valvular bioprosthesis and the proceeding of achievement 1. TICHftlCA FIELD S e present invention relates to a cardiac valvular biopros tics,used in cardiac valvular replacements and to the proceedi achievement. 2» BACKGROUND OF PRIOR ABS Llettallic valvular prosthetic of different constructions ar known. The drawback of these prosthesis that the beares are obliga submi ed to a chronical anticoagulant treatment. The bioprosthetics made from a pericardium of calf,human du mater and broad fascia are more known. The drawback of these prosthesis is;their cuspa does not.pr an adequate anatomical form and their resistence is reduced. The valvular bioprosthetics from an aorta of domestic pig a also known. he drawback of these bioprosthetics is that,due to short fibres with great fibrilar spaces for the fat storehouse, they present a more reduced resistence in time. 3. BRI2F SUUK.ARY OF ETV-aKTIOJx The cardiac valvular bioprosthetics,in accordance with the invention, emove the above drawback,in a view to obtain a great resistence by using as biological material, n aortic valva from wild boar, ear or other animal, ith a special structure of the tissues,applied on a metallic support or plastic material by ag of a relation stratum from knited textile material and the hear fixation making by agency of a burclat ring. The biologic material contains: n aortic valva of wild boar, or other animal, ak ' ed with the aortic wall and inte ven±ricular se tum,immedia ely after the animal sacrifice. The aortic valva of wild boar is a valva with three depth cuspae which achieve some nests which much prc-Ia-e under the ho zontal plan which passes through the valvular ring. o transligh the cuspae appear semitransparent,the maximum tranparence being the center cuspae.Also,the presence of dense fascicolae of fibr is observed in length of cuspa,between ccmisures,.approximately parallel with the cuspa edge which is free,the length of these fibres and the parallel sitting(small spaces between the fibres giving to the tissue an incresed resistence and elasticity,tis submited to a very intensive mechanic requirement * The support for the valva is made from a basis and a superst ture.The basis has a circular form with the diameter depending the valva diameter which must be replaced(between. l-2_-ιr..),inter- rupted by resistence pillars from which so εoneε,disposed in th middle of flankeies basis and.the others,in the middle of curve between two flankeies. The superstructure is formed from three flankeies like an is triangle,disposed at 120 ,between the superior tips. The passing from a tip to the other,is formed on- a curve whi fiddly follows the natural form of biologic valva which must b mounted on the support. Each triangle flankeies is disposed with the small side on support basis,the opposite tip to basis is rounded and,in inter has a window of the same form and a prominence for fixing the s The burelat ring can be made from knited textile material,pl material or siliconal material. * The proceeding of achievement of cardiac valvular bioprosth consists in taking the biologic material from the wild boar,imm tely after sacrifice.They t a ke the aortic valva with the aortic and a side of the in rventricular septum,it is washed in phys logic serum in a v±sw to eliminate the blood,the muscular fibr are eliminated from the septal cuspa and,from the aorta,the su of tissue.Swabs are introduced in cuspae for maintaining the f and they are introduced in keeping solutions and sterilization, they are stored in containers at 6-12° and after 4-3h,the biolo material is pulled and prepared for mounting on tho metallic s The preparing consists in eliminating all muscular fibres f the cuspae surface and cutting the aortic wall in concordance the form of superior edge of metallic support, ressed with a textile stratum. The metallic support is separately prepared by dressing wit knited textile material with a tubular form,introduced from dow wards to upwards through the metallic support and after,the sup edge- of the tube( extile material) is bended over the flankeies tips and is pulled under the in erior edge of support with S-10 shorter than the other edge of inferior textile tub--. -Further on,the surplus of textile material is remove,compris between flankeies and the edge must be cut with thread from the exterior to the interior of edges for being plugged. The exterior cylinder is fixed in few points(six) of .the bas of metallic support,the surplus is cut and bended over its edge the burelat ring is applied and fixed in few points on the supp basic(through the textile stratum and the tube of support basis The edge of the interior cylinder must be bended over the burel ring and cut around with a permanent thread. -Further on, he biologic ma erial,previously prepared on the dressed support is mounted by cutting with two threads and its introduction being made through the support interior.! seam is between the aortic valvular ring and the inferior edge of the dressed metallic support,the second seam is made between the pr aortic wall and the superior edge of the support.After ail thes a band from the same knited textile material is applied on the superior edge of dressed support and the biologic material thus sewed so that it covers the seam between the biologic material support for protecting the seam. Until its using,all make procedeeing is kept in keeping sol ' and sterilization , ccomplishing a sterile medium. 4.ΪSΔITS OF IEr-USTBlA CHIEV lirT The cardiac valvular bioprosthetics,in accordance with the vention,can be achieved on an industrial or se iindustrial way providin ,first at all, he source of biologic material as well the means necessary for its make.For obtaining the prosthesis placements in man,it is necessary to make their tests by some apparatus which determine their resistence and their hidrodyna p.erformances♦. 5-SHORT PRESEN AI0I7 OF EΕ * FIGURSS e illustrate an achievement also regarding the figures 1-4 representing-t -fig.1-sight with section through bioprosthetics -fig, -sight with section through the flankey tip A-A -figβ3-sight " with section B-3 / -fig.4-sight from face of metallic support 6.DETAILΞ) DESCRIPTION OF ITYISI IQN The cardiac valvular bioprosthetics,in accordance with the invention,is made from a biologic material 1(aortic valva of wi boar,bear or- other animal) with a special structure which is ap plied on metallic support 2 or plastic material by agency of a stratum . for * contact from knited textile material and the fixa on the- heart accomplishing by agency of a burelat ring _4 from textile mat rial, lastic material or siliccnic rubber. The aortic valva of wild boar is a prosthesis with three dee cuspae a,formed from dense fascicolae of fibres on the cuspa le between co isures approximately parallel with the free edge cf The support _2.-for the prosthesis 3. is made from a basis k_ an suoerstructure B. The basis A has a circular form with a diameter depending o prosthesis diameter which must be replaced(betv/een 15-33iam).and on the circum erence,it presents a tube b_,l-2mm,interrupted b some resictence pills c_ from which someones in the middle of t flankeies _d and the others in the middle of the curve between two flankeies. The superstructure 3 is formed by three flankeies d with an isoscel triangle form,disposed at 120° between the superior ti The passing from a tip to the other is made on a curve f which fidelly follows the natural form of the biologic prosthesis wh must be mounted on the support. Each flankey _d is set with the small side _ on the basis A, the tip opposite to the basis,is rounded and,in interior,prese a window h of the same form and a prominence l or fixing the seam material. The proceeding of achievement of cardiac valvular bioprosth consists in taking the aortic prosthesis 1 with the aortic wal anδ a side from int rventricular septum k of the wild boar, he wash 'it in physiologic serum for blood removing,the muscular fibres of septal cuspae are eliminated and,also,the tissue sup of the aorta. he swabs are introduced in cuspae for the form m taining and they are introduced in keeping solutions and steril tion with . glutaraldehida 0,β25,tamponed with phosphat at h 7,2 7,4.ϊhey are deposited in containers at 5-12° G,after 48h,the biologic material is taken and prepared for its mounting on the support 2 . The preparing consists in eliminating the muscular fibres of the cuspae surface _a and in cutting the aortic wall in accord with the superior edge of the dressed support 2 with the stratu from textile material. he metallic support 2 is separately prep by dressing with knited textile material 3_ of tubular form,intr duced from downwards to upwards through the support _2. The material 3 , is bended over the tips _e and the tube 1 pull under the inferior edge of a support 2 with β-lOmm shorter than the end m of a material 3..Further on,the material surplus comp between the flankeies d and the edgesare cut with thred from th exterior to the interior of the edges for being plugged. The cylinder _1 is fixed in few points(six) on the basis A.,t surplus is cut and it is bended over the ' edge,the burelat ring is applied and fixed in few points on the basis i The cylinder m is bended over the ring _4 and they cut around with a permane thread. Further on,the biologic material 1 is mounted .and previously prepared on th support 2 by sewing with two threads,its intro tion being made through the interior of the support 2- A seam is made between the aortic valvular ring and thevinfe edge of the support 2 -and the second seam, etween the prepared wall j and the superior edge of the support 2.After all these, band 3 . from the same knited textile material is applied on the or edge of the dressed support _2 and the biologic material ^ so cut that it covers the seam from the biologic material ___[ and th support 2 for its protection. All proceeding of achievemnt is made in sterile medium. Until its utilisation,tho prosthesis must be kept in keeping solution and st rilisation. 7. DVAN GES The cardiac valvular prosthesis and the proceeding of its achievement present the following advantages; -a greater resistsnee in time -no requires a permanent anticoagulant treatment -the employment of this prosthesis is indicated specially fo certain categories of patients as: young women,ulcer, ith diso ders of sanguine chrasa,special social circumstances (braάips c difficult access to medical assistence) , ypertensive patients(t whom the prosthesis of pig are unadvisable). C PI

Claims: - •-•T A T?*"? 1.Cardiac v-alvul-ar bioprosthetics,characterised by the emplo as biologic material of an aortic valva(l) of wild boar, ear or other animal(for obtaining a greater resistence in time) with d faccicola-i of fibres on the cuspa length(a) 'between comis res,a ximately parallel with the free edge of this,the length of thes fibres and the parallel dispersion giving to the tissue,an incr resistence and elasticity which can resist to mechanic demands great intensity,the prosthesis being applied on a metallic s p or plastic material by agency of a conection stratum(3) from kn textile, material and the fixation on the heart being made by ag of a burelat ring(4) from textile material,plastic or siliconic 2.Bioprosthetic,in accordance with the claim l,is characteri by; metallic support(2) formed from a basis (A) and a suprestr (B) from which the basis(A) has a circular form with a diameter according to the prosthesis diameter which must be replaced and, the circumference,it presents a tube(b) of l-2mm,int rrupted by resistence pills(e),the superstructure(B) .of a suppor (2) being from three flankeies(d) in an isoscel triangle form,disposed at between the superior tips(e),the coupling between the tips bein on a curve(f) similar to natural biologic valva,each triangle fl being set with the small side(g) on the support basis, he tip(e) opposite to basis,is rounded and,in interior presenting a window with a same form and prominence(i) for fixing the material of se 3.The achievement proceeding of cardiac valvular bioprostheti according with claims 1,2 is characterized by:for its make,the a valva(l) is taken,also an aortic wall(j) and a side of in ervent septum,immediately after the animal sacrifice,it is washed with logic serum for blood removing,the muscular fibres being elimina from the septal cuspa and the tissue surplus from the aorta,swab are introduced in cuspae,after,theyare introduced in a keeping s OMP -3- tion and sterilization,they are deposed in containers at 6-1 and after 48 h,the biologic material must be pulled and the aortic wall(j) peeled,the metallic support(2) is separately dressed with a tubular knited textile material(3) which bend over the flankeies tips(d) ,they cut and sew,the exterior cyl der must fixed,the burelat ring(4) is applied,over which the interior C3-Iinder(m) bends and it is sewed on the support th achieved,they applied with two seams the prepared biologic material(I) after which,on the superior edge of support,dres with a fixed biologic material (j),a band(5) from knited tex material,is applied for the seam protection.

Inventors: DOBRE MIRCEA, GHERGHICEANU DAN, POP D POPA IOAN
Applicants: DOBRE MIRCEA, GHERGHICEANU DAN, POP D POPA IOAN, SPITALUL CLINIC FUNDENI
Application year: 1981
Main classification: A61F1
IPC codes: A61F2