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WO1992013502A1 - Artificial heart valve - Google Patents

Artificial heart valve Download PDF

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Publication number
WO1992013502A1
WO1992013502A1 PCT/ES1992/000014 ES9200014W WO9213502A1 WO 1992013502 A1 WO1992013502 A1 WO 1992013502A1 ES 9200014 W ES9200014 W ES 9200014W WO 9213502 A1 WO9213502 A1 WO 9213502A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
ring
masts
pericardium
veils
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.)
Ceased
Application number
PCT/ES1992/000014
Other languages
Spanish (es)
French (fr)
Inventor
José Benito GARCIA GONZALEZ-MORO
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.)
Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to BR929204120A priority Critical patent/BR9204120A/en
Publication of WO1992013502A1 publication Critical patent/WO1992013502A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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

Definitions

  • the invention relates to a new artificial cardiac valve for replacing the human valves that are sick or dysfunctional and which is part of the group of biological valve substitutes or "bioprostheses" also called valvular Xenografts, that is, valves made of biological tissues. and in this case with caliper peri ⁇ cardio treated with glutaraldehyde and fixed on a flexible reinforcement composed of a polymer called Celcon.
  • Ionescu-Shiley pericardium biopró ⁇ esis which was the name under which they were commercialized, were of very low thrombogenicide, probably due to their excellent hydrodynamics, and it was not necessary to administer anticoagulants for life as was the case with other biological valves. implanted in nitral position or with mechanical valve substitutes.
  • Esxudios made by the inventor (Biologic * Bioprosthetic Valves, Yorke Medical Books, ⁇ 986) have clinically proven this beneficial aspect.
  • an artificial heart valve comprising a flexible reinforcement composed of a valve ring and masts that rise from the ring and define breasts between them, with shell or scallop being the part of the ring corresponding to each breast; opening and closing veils of the valve that are fixed to said armature and which are sized in such a way that said masts are projected beyond the cusp; a coating or forage of pericardium applied to said reinforcement; and some means of fixing the valve to the patient's heart tissue.
  • the reinforcement is made of a copolymer of high fatigue resistance acetate, specifically the polymer called Celcon, and has between five and six holes in each breast and in the masts to fix each pre-selected veil of tissue in them.
  • the means for fixing the valve consist of a silicone rubber ring, specifically Silastic, covered with tubular polyester fabric, specifically Dacron, to pass the sutures of the patient's ring and implant So the valve.
  • the pericardium coating is based on calf pericardial tissue treated with purified glutaraldehyde in a solution buffered with phosphate salt at pH 7.4, without pressure, and has a thickness of ⁇ 6 to 22 mm.
  • the valve of the invention has been subjected to various operating tests.
  • Figure 1 illustrates the valve armature of the invention
  • Figure 2 shows the lining of the armature with treated calf pericardium
  • Figure 3 is a sagittal section of the valve of the invention
  • Figure 4 shows the valve already assembled with the pericardial veils
  • Figure 5 illustrates the internal projection of the valve with the semicircular shape of the three breasts covered with pericardium.
  • the valve of the invention includes a reinforcement of a high-strength acetate copolymer, known as Celcon, which is integrated by a valve ring. 1 and some 2 masts that rise from the ring and define breasts between them, being practiced in each breast and in the masts between five and six holes 3 to fix in them each pre-selected veil 4 of pericardial tissue and according to the valve sizes .
  • Figure 1 shows the scallop or shell shape of the ring for each breast of the valve.
  • FIG. 2 shows a veil 4 separated from the valve, while the veils applied to the valve are shown in dashed lines.
  • A the fixation of the pericardium to the masts 2 of the armor, as well as the inner lining or forage, and with B each veil 4 of pre-selected pericardium is shown to be fixed to the masts 2.
  • B each veil 4 of pre-selected pericardium is shown to be fixed to the masts 2.
  • Fig. 3 the veal peritonum of veil 4 has been designated with A, with B the fixation of the peri ⁇ cardio to the armor, with C the fabric-coated valve ring, with D the sili rubber suture ring - Cona (Silastic) lined with tubular polyester fabric (Dacron) to pass the sutures of the patient's ring and thus implant the valve, and with E the pericardium already fixed to the reinforcement.
  • Figure 4 shows in A and B the veils 4 already fixed at the base and along the scallop and the masts 2 of the armor. All the pericardial tissue of the veils is treated with purified glutaraldehyde in phosphate salt buffered solution at pH 7.4 and without Zion.
  • Figure 5 illustrates the semi-circular shape of the three sinuses of the valve with an inner pericardium lining that has been designated with 5 and which, as stated, has been applied by sewing to the hard shell.
  • each pericardial veil ranges between 0.3 70.45 ⁇ im for valves with outside diameters of 19 to 23 mm, between 0 , 42 and 0.52 mm for valves with outside diameters from 25 to 29 mm and between 0.50 and 0.62 mm for valves with outside diameters from 3 to 33 mm. Therefore, the sizes of the valves to be implanted range from 19 mm in external diameter, including the Dacron coating, and 33 mm.
  • the projection from the base of the valve to the top of the masts of the armor with the veils already mounted is, in millimeters, 7 for size 19 »8 for sizes 21 and 23, 9 for size 25, 10 for sizes 27 and 29 and 11 for sizes 3 and 33- Coated inside diameters, in millimeters, are 15 for size 19, 17 for size 21, 19 for size 23, 21 for size 25, 23 for size 27, 25 for size 29, 27 for size 3 and 9 for size 33.

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)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The artificial heart valve is comprised of a flexible frame consisting of a valve ring (1) and posts (2) extending from the ring and defining some recesses, said ring having the shape of a shell; voiles (4) for opening and closing the valve are fixed to said frame and project beyond the apex of said posts (2); a calf heart sac coating applied to said frame with a thickness from 16 to 22 mm; and a ring for fixing the valve to the heart tissues of the patient. The valve of the invention is useful as substituent for failing or dysfunctional human valves.

Description

VALVULA CARDIACA ARTIFICIAL ARTIFICIAL CARDIAC VALVE

CAMPO DEL INVENTOFIELD OF THE INVENTION

El invento se refiere a una nueva válvula car¬ diaca artificial para sustituir a las válvulas humanas en¬ fermas o disfuncionantes y que forma parte del grupo de sustitutivos valvulares biológicos o "bioprótesis" también llamadas Xenoinjertos valvulares, es decir válvulas confe_c cionadas con tejidos biológicos y en este caso con peri¬ cardio de ternera tratado con glutaraldehído y fijado so¬ bre una armadura flexible compuesta por un polímero llama¬ do Celcon.The invention relates to a new artificial cardiac valve for replacing the human valves that are sick or dysfunctional and which is part of the group of biological valve substitutes or "bioprostheses" also called valvular Xenografts, that is, valves made of biological tissues. and in this case with caliper peri¬ cardio treated with glutaraldehyde and fixed on a flexible reinforcement composed of a polymer called Celcon.

ANTECEDENTES DEL INVENTOBACKGROUND OF THE INVENTION

A principios de la década de los 70, el Dr. Marión Ionescu de Leeds, Inglaterra, ideó la válvula de pe ricardio de ternera de 3 velos, tratada con glutaraldehído y montada por el exterior de un anillo rígido de titanio. Posteriormente, la válvula fue modificada, disminuyéndose el perfil de la misma e igualmente cambiándose el anillo rígido por uno flexible de plástico (Delrin) . Estas modi¬ ficaciones de la válvula de pericardio significaron una mejora hidráulica que fue demostrada en estudios in vitro por Reul y posteriormente in vivo por diversos investiga¬ dores (Cardiac Prostheses Symposium, Montreux, Suiza, 1985), incluido el inventor.In the early 1970s, Dr. Marión Ionescu of Leeds, England, devised the 3-veal calf petrol valve, treated with glutaraldehyde and mounted on the outside of a rigid titanium ring. Subsequently, the valve was modified, reducing its profile and also changing the rigid ring to a flexible plastic ring (Delrin). These modifications of the pericardium valve meant a hydraulic improvement that was demonstrated in in vitro studies by Reul and later in vivo by various investigators (Cardiac Prostheses Symposium, Montreux, Switzerland, 1 985), including the inventor.

Igualmente se constató que las biopróτesis de pericardio Ionescu-Shiley, que fue el nombre con que se co ercializaron, eran de muy baja trombogenicida , probable¬ mente por su excelente hidrodinámica, no siendo necesario administrar anticoagulantes de por vida como sucedía con otras válvulas biológicas implantadas en posición nitral o con los sustitutivos valvulares mecánicos.Likewise, it was found that the Ionescu-Shiley pericardium biopróτesis, which was the name under which they were commercialized, were of very low thrombogenicide, probably due to their excellent hydrodynamics, and it was not necessary to administer anticoagulants for life as was the case with other biological valves. implanted in nitral position or with mechanical valve substitutes.

Esxudios realizados por el inventor (Biologic* Bioprosthetic Valves, Yorke Medical Books, ^986) han com¬ probado clínicamente este aspecto tan beneficioso.Esxudios made by the inventor (Biologic * Bioprosthetic Valves, Yorke Medical Books, ^ 986) have clinically proven this beneficial aspect.

Diseños similares a la válvula de Ionescu- -Shϊley, es decir con los velos pericárdicos montados por el exterior de la armadura de la misma, con algunas modi¬ ficaciones, .fueron apareciendo en el mercado para uso clí¬ nico a principios de la década de los 80.Designs similar to the Ionescu- -Shϊley valve, that is to say with pericardial veils mounted on the outside of the armor of the same, with some modifications, were appearing on the market for clinical use at the beginning of the decade of the 80s.

Sin embargo, la excelente hidráulica de este tipo de bioprótesis de pericardio no se vio acompañada en la misma proporción por su durabilidad, dado que comenza¬ ron a aparecer progresivamente roturas de los velos, su¬ puestamente por roce-abrasión contra el forro de los so¬ portes valvulares, y también desgarros de los velos en los puntos de fijación a los soportes, tal como fue publicado por el propio Ionescu y otros (Cardiae Prostheses Symposium, Montreux, Suiza, 1985).However, the excellent hydraulics of this type of pericardium bioprosthesis were not accompanied in the same proportion by their durability, given that they gradually began to break the veils, supposedly by rubbing-abrasion against the lining of the Valve supports, and also tearing of the veils at the fixation points to the supports, as published by Ionescu and others (Cardiae Prostheses Symposium, Montreux, Switzerland, 1985).

Estas disfunciones han sido demostradas in vitro mediante aceleradores de fatiga, encontrándose que la abrasión o roce del velo pericárdico contra la parte interna del forraje de la armadura de la válvula acaba rompiendo el tejido tras unos cien millones de ciclos. Igualmente el inventor, tras 1 años de experiencia con este tipo de válvulas, ha evidenciado la incompetencia de las mismas por pérdida de la sutura que fija los velos a la armadura o por desgarro de los mismos merced a la sutu¬ ra que rodea el velo para fijarlo a la armadura.These dysfunctions have been demonstrated in vitro by means of fatigue accelerators, being found that the abrasion or rubbing of the pericardial veil against the internal part of the forage of the valve armature ends up breaking the tissue after about one hundred million cycles. Likewise, the inventor, after 1 years of experience with this type of valves, has evidenced their incompetence due to the loss of the suture that fixes the veils to the armor or due to their tearing thanks to the suture surrounding the veil. to fix it to the armor.

Por consiguiente, había necesidad de una vál¬ vula biológica que, en los movimientos de los velos de apertura y cierre, evitara la abrasión haciendo que se produzca un roce de pericardio con pericardio y no contra el forraje interior de material protésico de la válvula, conservando ésta al propio tiempo un buen comportamiento hidráulico. Esta necesidad ha quedado resuelta por el pre¬ sente invento, que ha creado una válvula cardiaca de grar. durabilidad y de excelentes características de circulaciór. de la sangre. SUMARIO DEL INVENTOTherefore, there was a need for a biological valve that, in the movements of the opening and closing veils, prevented abrasion by causing a pericardium friction with pericardium and not against the inner forage of prosthetic valve material, keeping this at the same time a good hydraulic behavior. This need has been resolved by the present invention, which has created a heart valve. durability and excellent circulation characteristics. of the blood. SUMMARY OF THE INVENTION

Según el presente invento, se proporciona una válvula cardiaca artificial que comprende una armadura flexible integrada por un anillo valvular y unos mástiles que se alzan desde el anillo y que definen senos entre ellos, teniendo forma de concha o escalope la parte del anillo correspondiente a cada seno; unos velos de apertura y cierre de la válvula que van fijados a dicha armadura y que están dimensionados de tal manera que se proyectan más allá de la cúspide dichos mástiles; un revestimiento o forraje de pericardio aplicado a dicha armadura; y unos me dios de fijación de la válvula al tejido cardiaco del pa¬ ciente . Preferiblemente, la armadura es de un copolí- mero de acetato de alta resistencia a la fatiga, concreta¬ mente el polímero llamado Celcon, y lleva entre cinco y seis orificios en cada seno y en los mástiles para fijar en ellos cada velo preseleccionado de tejido pericárdico. Por su parte, los medios de fijación de la val vula consisten en un anillo de caucho de silicona, concre¬ tamente Silastic, revestido con tejido tubular de poli- éster, concretamente Dacron, para pasar los puntos de sutura del anillo del paciente e implantar así la válvula. Por último, el revestimiento de pericardio con siste en tejido pericárdico de ternera tratado con glu¬ taraldehído purificado en solución tamponada con sal fos¬ fato a pH 7,4, sin presión, y tiene un grosor de Λ6 a 22 mm. La válvula del invento ha sido sometida a di¬ versos ensayos de funcionamiento. Así, estudios in vitro (Prof. H. Reul, Helmholtz-Institute for Biomedical Engg., Aachen, Alemania) han demostrado que con el forraje inte¬ rior de pericardio tratado de la válvula la durabilidad de la misma se incrementa hasta alcanzar los cuatrocientos millones de ciclos, lo cual significa incrementar la dura- bilidad mecánica tres veces más. Igualmente, y para elimi¬ nar el fallo por rotura o pérdida de fijación de los velos a los mástiles de la armadura, se ha incrementado el per¬ fil del velo con respecto al perfil de los mástiles y se ha cubierto el conjunto de pericardio, habiéndose desarro¬ llado también un nuevo concepto de fijación de los velos pericárdieos a los mástiles de la armadura de manera que no existen puntos de sutura alrededor del mástil para fi¬ jar los velos y mantenerlos competentes. Por otro lado, y dadas las características hidráulicas de las válvulas de pericardio montadas por fuera de la armadura, siempre su¬ periores a otras válvulas biológicas, se ha reducido el grosor del pericardio del forraje, realizándose el mismo de forma que la válvula preserve al máximo su orificio in- terior eficaz. Es decir que se ha incrementado su durabi¬ lidad mecánica mediante el forraje interior del pericardio y la fijación a los mástiles de la armadura, y se preserva la óptima hidráulica de estos diseños.According to the present invention, an artificial heart valve is provided comprising a flexible reinforcement composed of a valve ring and masts that rise from the ring and define breasts between them, with shell or scallop being the part of the ring corresponding to each breast; opening and closing veils of the valve that are fixed to said armature and which are sized in such a way that said masts are projected beyond the cusp; a coating or forage of pericardium applied to said reinforcement; and some means of fixing the valve to the patient's heart tissue. Preferably, the reinforcement is made of a copolymer of high fatigue resistance acetate, specifically the polymer called Celcon, and has between five and six holes in each breast and in the masts to fix each pre-selected veil of tissue in them. pericardial On the other hand, the means for fixing the valve consist of a silicone rubber ring, specifically Silastic, covered with tubular polyester fabric, specifically Dacron, to pass the sutures of the patient's ring and implant So the valve. Finally, the pericardium coating is based on calf pericardial tissue treated with purified glutaraldehyde in a solution buffered with phosphate salt at pH 7.4, without pressure, and has a thickness of Λ 6 to 22 mm. The valve of the invention has been subjected to various operating tests. Thus, in vitro studies (Prof. H. Reul, Helmholtz-Institute for Biomedical Engg., Aachen, Germany) have shown that with the internal forage of treated pericardium of the valve the durability of the valve is increased to four hundred million cycles, which means increasing the duration mechanical bility three times more. Likewise, and to eliminate the failure due to breakage or loss of fixation of the veils to the masts of the armor, the profile of the veil with respect to the profile of the masts has been increased and the pericardium assembly has been covered, having also developed a new concept of fixing the pericardial veils to the masts of the armor so that there are no stitches around the mast to fix the veils and keep them competent. On the other hand, and given the hydraulic characteristics of pericardium valves mounted outside the frame, always exceeding other biological valves, the thickness of the forage pericardium has been reduced, the same being done so that the valve preserves maximum effective inner hole. That is to say, its mechanical durability has been increased by the internal forage of the pericardium and the fixation to the masts of the armor, and the optimum hydraulics of these designs are preserved.

BREVE DESCRIPCIÓN DE LOS DIBUJOSBRIEF DESCRIPTION OF THE DRAWINGS

Con el fin de ofrecer una exposición más deta¬ llada del invento, se describirá seguidamente una realiza¬ ción preferida del mismo haciendo referencia a los dibujos esquemáticos adjuntos, en los que:In order to provide a more detailed exposition of the invention, a preferred embodiment thereof will be described below with reference to the accompanying schematic drawings, in which:

La figura 1 ilustra la armadura de la válvula del invento, la figura 2 muestra el revestimiento de la armadura con pericardio de ternera tratado, la figura 3 es un corte sagital de la válvula del invento, la figura 4 muestra la válvula ya montada con los velos pericárdicos, y la figura 5 ilustra la proyección interior de la válvula con la forma semicircular de los tres senos re¬ vestidos de pericardio. DESCRIPCION DETALLADA DE LOS DIBUJOSFigure 1 illustrates the valve armature of the invention, Figure 2 shows the lining of the armature with treated calf pericardium, Figure 3 is a sagittal section of the valve of the invention, Figure 4 shows the valve already assembled with the pericardial veils, and Figure 5 illustrates the internal projection of the valve with the semicircular shape of the three breasts covered with pericardium. DETAILED DESCRIPTION OF THE DRAWINGS

Como podrá apreciarse en las figuras 1 a 5 de los dibujos, la válvula del invento incluye una armadura de un copolímero de acetato de alta resistencia a la fati¬ ga, conocido con el nombre de Celcon, la cual está integra da por un anillo valvular 1 y unos mástiles 2 que se alzan desde el anillo y definen senos entre ellos, estando prac¬ ticados en cada seno y en los mástiles entre cinco y seis agujeros 3 para fijar en ellos cada velo 4 preseleccionado de tejido pericárdico y según los tamaños valvulares. Se observa en la figura 1 la forma en escalope o concha del anillo para cada seno de la válvula.As can be seen in Figures 1 to 5 of the drawings, the valve of the invention includes a reinforcement of a high-strength acetate copolymer, known as Celcon, which is integrated by a valve ring. 1 and some 2 masts that rise from the ring and define breasts between them, being practiced in each breast and in the masts between five and six holes 3 to fix in them each pre-selected veil 4 of pericardial tissue and according to the valve sizes . Figure 1 shows the scallop or shell shape of the ring for each breast of the valve.

La figura 2 muestra un velo 4 separado de la válvula, en tanto que los velos aplicados a la válvula se muestran en línea de trazos. En esta figura se ha designa¬ do con A la fijación del pericardio a los mástiles 2 de la armadura, así como el revestimiento o forraje interior, y con B se muestra cada velo 4 de pericardio preseleccionado para ser fijado a los mástiles 2. Una vez montados los ve¬ los 4, se observa el posicionamiento exterior de cada velo y su proyección con respecto a los mástiles, así como el perfil de los mismos.Figure 2 shows a veil 4 separated from the valve, while the veils applied to the valve are shown in dashed lines. In this figure it has been designated with A the fixation of the pericardium to the masts 2 of the armor, as well as the inner lining or forage, and with B each veil 4 of pre-selected pericardium is shown to be fixed to the masts 2. A Once the 4 are mounted, the external positioning of each veil and its projection with respect to the masts are observed, as well as the profile thereof.

En la figura 3 se ha designado con A el peri- cardio de ternera del velo 4, con B la fijación del peri¬ cardio a la armadura, con C el anillo valvular revestido de tejido, con D el anillo para suturar de caucho de sili- cona (Silastic) revestido con tejido tubular de poliéster (Dacron) para pasar los puntos de sutura del anillo del paciente y así implantar la válvula, y con E el pericardio ya fijado a la armadura.In Fig. 3 the veal peritonum of veil 4 has been designated with A, with B the fixation of the peri¬ cardio to the armor, with C the fabric-coated valve ring, with D the sili rubber suture ring - Cona (Silastic) lined with tubular polyester fabric (Dacron) to pass the sutures of the patient's ring and thus implant the valve, and with E the pericardium already fixed to the reinforcement.

En la figura 4 se muestran en A y B los velos 4 ya fijados en la base y a todo lo largo del escalope y de los mástiles 2 de la armadura. Todo el tejido pericár- dico de los velos va tratado con glutaraldehído purificado en solución tamponada con sal fosfato a pH 7,4 y sin pre- sion.Figure 4 shows in A and B the veils 4 already fixed at the base and along the scallop and the masts 2 of the armor. All the pericardial tissue of the veils is treated with purified glutaraldehyde in phosphate salt buffered solution at pH 7.4 and without Zion.

Por último, la figura 5 ilustra la forma semi¬ circular de los tres senos de la válvula con un revesti¬ miento interior de pericardio que se ha designado con 5 y que, como se ha dicho, se ha aplicado cosiendo a la arma¬ dura un tejido de pericardio tratado de un grosor com¬ prendido entre 16 y 22 mm.Finally, Figure 5 illustrates the semi-circular shape of the three sinuses of the valve with an inner pericardium lining that has been designated with 5 and which, as stated, has been applied by sewing to the hard shell. a treated pericardium tissue of a thickness comprised between 16 and 22 mm.

Como ejemplos de realización específicos de la válvula cardiaca del invento, cabe señalar que ésta está estructurada de tal manera que el grosor de cada velo pericárdico oscila entre 0,3 70,45 πim para válvulas con diámetros exteriores de 19 a 23 mm, entre 0,42 y 0,52 mm para válvulas con diámetros exteriores de 25 a 29 mm y en¬ tre 0,50 y 0,62 mm para válvulas con diámetros exteriores de 3 a 33 mm. Por tanto, los tamaños de las válvulas que han de ser implantadas oscilan entre 19 mm de diámetro ex¬ terior, incluyendo el recubrimiento de Dacron, y 33 mm.As specific embodiments of the heart valve of the invention, it should be noted that it is structured such that the thickness of each pericardial veil ranges between 0.3 70.45 πim for valves with outside diameters of 19 to 23 mm, between 0 , 42 and 0.52 mm for valves with outside diameters from 25 to 29 mm and between 0.50 and 0.62 mm for valves with outside diameters from 3 to 33 mm. Therefore, the sizes of the valves to be implanted range from 19 mm in external diameter, including the Dacron coating, and 33 mm.

Por otra parte, la proyección desde la base de la válvula hasta la cima de los mástiles de la armadura con los velos ya montados es, en milímetros, de 7 para el tamaño 19» de 8 para los tamaños 21 y 23, de 9 para el ta¬ maño 25, de 10 para los tamaños 27 y 29 y de 11 para los tamaños 3 y 33- Los diámetros interiores recubiertos, en milímetros, son de 15 para el tamaño 19, 17 para el tamaño 21, 19 para el tamaño 23, 21 para el tamaño 25, 23 para el tamaño 27, 25 para el tamaño 29, 27 para el tamaño 3 y 9 para el tamaño 33.On the other hand, the projection from the base of the valve to the top of the masts of the armor with the veils already mounted is, in millimeters, 7 for size 19 »8 for sizes 21 and 23, 9 for size 25, 10 for sizes 27 and 29 and 11 for sizes 3 and 33- Coated inside diameters, in millimeters, are 15 for size 19, 17 for size 21, 19 for size 23, 21 for size 25, 23 for size 27, 25 for size 29, 27 for size 3 and 9 for size 33.

La descripción anterior concierne a lo que se considera como la realización preferida de la válvula cardiaca del invento. No obstante, los expertos comprende¬ rán que será posible efectuar diversas modificaciones de detalle en la estructura de la válvula descrita e ilustra¬ da sin apartarse del espíritu y ámbito del invento. Por tanto, se pretende que el alcance del invento quede limi- tado únicamente por el contenido de las reivindicaciones adjuntas. The above description concerns what is considered as the preferred embodiment of the heart valve of the invention. However, experts will understand that it will be possible to make various modifications to the structure of the valve described and illustrated without departing from the spirit and scope of the invention. Therefore, it is intended that the scope of the invention be limited only by the content of the appended claims.

Claims

REIVINDICACIONES 1.- Válvula cardiaca artificial para sustituir a las válvulas humanas enfermas o disfuncionantes, carac¬ terizada porque comprende una armadura flexible integrada por un anillo valvular (1) y unos mástiles (2) que se alzan desde el anillo y definen senos entre ellos, tenien- do forma de concha o escalope la parte del anillo corres¬ pondiente a cada seno, unos velos (4) de apertura y cierre de la válvula fijados a dicha armadura, estando dimensio- nados dichos velos de tal manera que su perfil rebasa el perfil de dichos mástiles; un revestimiento o forraje de pericardio (5) aplicado a dicha armadura; y unos medios (D) de fijación de la válvula al tejido cardiaco del pa¬ ciente .1.- Artificial heart valve to replace diseased or dysfunctional human valves, characterized in that it comprises a flexible reinforcement composed of a valve ring (1) and masts (2) that rise from the ring and define breasts between them, the part of the ring corresponding to each breast being shaped like a shell or scallop, veils (4) for opening and closing the valve fixed to said reinforcement, said veils being dimensioned in such a way that their profile exceeds the profile of said masts; a lining or fodder of pericardium (5) applied to said reinforcement; and means (D) for fixing the valve to the patient's cardiac tissue. 2.- Válvula cardiaca según la reivindicación 1 , caracterizada porque la armadura es de un copolímero de acetato de alta resistencia a la fatiga y lleva entre cinco y seis orificios, en cada seno y en los mástiles (2) para fijar en ellos cada velo (4) preseleccionado de teji¬ do pericárdico.2. Heart valve according to claim 1, characterized in that the armor is made of an acetate copolymer of high fatigue resistance and has between five and six holes, in each breast and in the masts (2) to fix each veil in them (4) preselected pericardial tissue. 3.- Válvula cardiaca según una cualquiera de las reivindicaciones precedentes, caracterizada porque los medios (D) de fijación de la válvula consisten en un ani¬ llo de caucho de silicona revestido con tejido tubular de poliéster para pasar los puntos de sutura del anillo del paciente e implantar así la válvula. 4.- Válvula cardiaca según una cualquiera de las reivindicaciones precedentes, caracterizada porque el revestimiento de pericardio (5) consiste en tejido peri¬ cárdico de ternera tratado con glutaraldehído purificado en solución tamponada con sal fosfato a pH 7,4, sin pre- sión, y tiene un grosor de 16 a 22 mm. REIVINDICACIONES MODIFICADAS3. Cardiac valve according to any one of the preceding claims, characterized in that the means (D) for fixing the valve consist of a silicone rubber ring coated with tubular polyester fabric to pass the sutures of the ring of the patient and thus implant the valve. 4. Heart valve according to any one of the preceding claims, characterized in that the pericardium lining (5) consists of pericardial veal tissue treated with purified glutaraldehyde in phosphate buffered solution at pH 7.4, without pressure. , and has a thickness of 16 to 22 mm. MODIFIED CLAIMS [recibidas por la Oficina Internacional el 2 de Julio de 1992 (02.07.92); reivindicaciones 1 y 4 modificadas; las otras reivindicaciones quedan sin modificar[received by the International Bureau on July 2, 1992 (02.07.92); modified claims 1 and 4; the other claims remain unchanged (1 página)](1 page)] 1.- Válvula cardiaca artificial para sustituir a las válvulas humanas enfermas o disfuncionantes, caracterizada porque comprende una armadura flexible integrada por un ani¬ llo valvular (1) y unos mástiles (2) que se alzan desde el anillo y definen senos entre ellos, teniendo forma de concha o escalope la parte del anillo correspondiente a cada seno; unos velos (4) de apertura y cierre de la válvula fijados a dicha armadura, estando dimensionados dichos velos de tal manera que su perfil rebasa el perfil de dichos mástiles, sin que exista material protésico alguno en la parte exterior de los mismos; un revestimiento o forraje de pericardio selecti¬ vo (5) aplicado a dicha armadura; y unos medios (D) de fija¬ ción de la válvula al tejido cardiaco del paciente.1.- Artificial heart valve to replace diseased or dysfunctional human valves, characterized in that it comprises a flexible armor made up of a valve ring (1) and masts (2) that rise from the ring and define breasts between them, the part of the ring corresponding to each breast having a shell or scallop shape; veils (4) for opening and closing the valve fixed to said armature, said veils being sized such that their profile exceeds the profile of said masts, without any prosthetic material on the outside thereof; a coating or forage of selective pericardium (5) applied to said reinforcement; and means (D) for fixing the valve to the patient's heart tissue. 2.- Válvula cardiaca según la reivindicación 1, ca- racterizada porque la armadura es de un copolimero de aceta¬ to de alta resistencia a la fatiga y lleva entre cinco y seis orificios, en cada seno y en los mástiles (2) para fi¬ jar en ellos cada velo (4) preseleccionado de tejido pericár¬ dico. 3.- Válvula cardiaca según una cualquiera de las reivindicaciones precedentes, caracterizada porque los medios (D) de fijación de la válvula consisten en un anillo de cau¬ cho de silicona revestido con tejido tubular de pol éster para pasar los puntos de sutura del anillo del paciente e implantar asi la válvula.2. Cardiac valve according to claim 1, characterized in that the armor is made of a high-resistance aceta¬ co copolymer with fatigue and has between five and six holes, in each breast and in the masts (2) for fi ¬ jar in each veil (4) preselected pericardial tissue. 3.- Heart valve according to any one of the preceding claims, characterized in that the means (D) for fixing the valve consist of a silicone rubber ring coated with tubular polyester fabric to pass the suture points of the ring of the patient and thus implant the valve. 4.- Válvula cardiaca según una cualquiera de las reivindicaciones precedentes, caracterizada porque el reves¬ timiento interior selectivo de pericardio (5) consiste en tejido pericárdico de ternera tratado con glutaraldehido purificado en solución tamponada con sal fosfato a pH 7,4, sin presión, y tiene un grosor de 16 a 22 mm. 4. Cardiac valve according to any one of the preceding claims, characterized in that the selective inner lining of pericardium (5) consists of calf pericardial tissue treated with purified glutaraldehyde in phosphate buffered solution at pH 7.4, without pressure , and has a thickness of 16 to 22 mm.
PCT/ES1992/000014 1991-02-07 1992-02-06 Artificial heart valve Ceased WO1992013502A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
BR929204120A BR9204120A (en) 1991-02-07 1992-02-06 ARTIFICIAL HEART VALVE

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES9100324A ES2028611A6 (en) 1991-02-07 1991-02-07 Artificial heart valve.
ESP9100324 1991-02-07

Publications (1)

Publication Number Publication Date
WO1992013502A1 true WO1992013502A1 (en) 1992-08-20

Family

ID=8271120

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES1992/000014 Ceased WO1992013502A1 (en) 1991-02-07 1992-02-06 Artificial heart valve

Country Status (6)

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EP (1) EP0532719A1 (en)
AU (1) AU1261292A (en)
BR (1) BR9204120A (en)
CA (1) CA2080138A1 (en)
ES (1) ES2028611A6 (en)
WO (1) WO1992013502A1 (en)

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BR9204120A (en) 1993-06-08
EP0532719A1 (en) 1993-03-24
ES2028611A6 (en) 1992-07-01
AU1261292A (en) 1992-09-07
CA2080138A1 (en) 1992-08-08

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