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WO1992013502A1 - Valvule cardiaque artificielle - Google Patents

Valvule cardiaque artificielle Download PDF

Info

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
Application number
PCT/ES1992/000014
Other languages
English (en)
Spanish (es)
Inventor
José Benito GARCIA GONZALEZ-MORO
Original Assignee
Garcia Gonzalez Moro Jose Beni
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 Garcia Gonzalez Moro Jose Beni filed Critical Garcia Gonzalez Moro Jose Beni
Priority to BR929204120A priority Critical patent/BR9204120A/pt
Publication of WO1992013502A1 publication Critical patent/WO1992013502A1/fr

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

La valvule cardiaque artificielle comprend une structure flexible constituée par un anneau (1) de valvule et des éléments (2) qui font saillie depuis l'anneau et définissent entre eux des évidements, l'anneau ayant la forme d'une coquille; des voiles (4) d'ouverture et de fermeture de la valvule sont fixés à ladite structure et vont au-delà du sommet des éléments saillants (2); un revêtement de péricarde de veau appliqué à ladite structure avec une épaisseur de 16 à 22 mm; et un anneau pour fixer la valvule au tissu cardiaque du patient. La valvule de l'invention est utile comme composant de substitution de valvule humaine malade ou présentant un dysfonctionnement.
PCT/ES1992/000014 1991-02-07 1992-02-06 Valvule cardiaque artificielle WO1992013502A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
BR929204120A BR9204120A (pt) 1991-02-07 1992-02-06 Valvula cardiaca artificial

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES9100324A ES2028611A6 (es) 1991-02-07 1991-02-07 Valvula cardiaca artificial.
ESP9100324 1991-02-07

Publications (1)

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

Family

ID=8271120

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES1992/000014 WO1992013502A1 (fr) 1991-02-07 1992-02-06 Valvule cardiaque artificielle

Country Status (6)

Country Link
EP (1) EP0532719A1 (fr)
AU (1) AU1261292A (fr)
BR (1) BR9204120A (fr)
CA (1) CA2080138A1 (fr)
ES (1) ES2028611A6 (fr)
WO (1) WO1992013502A1 (fr)

Cited By (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5449385A (en) * 1991-05-08 1995-09-12 Nika Health Products Limited Support for a heart valve prosthesis
US5716399A (en) * 1995-10-06 1998-02-10 Cardiomend Llc Methods of heart valve repair
US6102944A (en) * 1997-03-27 2000-08-15 Edwards Lifesciences Corporation Methods of tissue heart valve assembly
US6425902B1 (en) 2001-05-04 2002-07-30 Cardiomend Llc Surgical instrument for heart valve reconstruction
US6598307B2 (en) 1999-11-17 2003-07-29 Jack W. Love Device and method for assessing the geometry of a heart valve
US6869444B2 (en) * 2000-05-22 2005-03-22 Shlomo Gabbay Low invasive implantable cardiac prosthesis and method for helping improve operation of a heart valve
US8308798B2 (en) 2008-12-19 2012-11-13 Edwards Lifesciences Corporation Quick-connect prosthetic heart valve and methods
US8460373B2 (en) 2002-12-20 2013-06-11 Medtronic, Inc. Method for implanting a heart valve within an annulus of a patient
US8641757B2 (en) 2010-09-10 2014-02-04 Edwards Lifesciences Corporation Systems for rapidly deploying surgical heart valves
US8696742B2 (en) 2009-06-26 2014-04-15 Edwards Lifesciences Corporation Unitary quick-connect prosthetic heart valve deployment methods
US8747463B2 (en) 2003-08-22 2014-06-10 Medtronic, Inc. Methods of using a prosthesis fixturing device
US8845720B2 (en) 2010-09-27 2014-09-30 Edwards Lifesciences Corporation Prosthetic heart valve frame with flexible commissures
US8986374B2 (en) 2010-05-10 2015-03-24 Edwards Lifesciences Corporation Prosthetic heart valve
US9005279B2 (en) 2010-11-12 2015-04-14 Shlomo Gabbay Beating heart buttress and implantation method to prevent prolapse of a heart valve
US9078747B2 (en) 2011-12-21 2015-07-14 Edwards Lifesciences Corporation Anchoring device for replacing or repairing a heart valve
US9125741B2 (en) 2010-09-10 2015-09-08 Edwards Lifesciences Corporation Systems and methods for ensuring safe and rapid deployment of prosthetic heart valves
US9155617B2 (en) 2004-01-23 2015-10-13 Edwards Lifesciences Corporation Prosthetic mitral valve
US9248016B2 (en) 2009-03-31 2016-02-02 Edwards Lifesciences Corporation Prosthetic heart valve system
US9314334B2 (en) 2008-11-25 2016-04-19 Edwards Lifesciences Corporation Conformal expansion of prosthetic devices to anatomical shapes
US9370418B2 (en) 2010-09-10 2016-06-21 Edwards Lifesciences Corporation Rapidly deployable surgical heart valves
US9439762B2 (en) 2000-06-01 2016-09-13 Edwards Lifesciences Corporation Methods of implant of a heart valve with a convertible sewing ring
US9468527B2 (en) 2013-06-12 2016-10-18 Edwards Lifesciences Corporation Cardiac implant with integrated suture fasteners
US9504566B2 (en) 2014-06-20 2016-11-29 Edwards Lifesciences Corporation Surgical heart valves identifiable post-implant
US9549816B2 (en) 2014-04-03 2017-01-24 Edwards Lifesciences Corporation Method for manufacturing high durability heart valve
US9554901B2 (en) 2010-05-12 2017-01-31 Edwards Lifesciences Corporation Low gradient prosthetic heart valve
US9554903B2 (en) 2005-05-24 2017-01-31 Edwards Lifesciences Corporation Rapid deployment prosthetic heart valve
US9603553B2 (en) 2009-10-27 2017-03-28 Edwards Lifesciences Corporation Methods of measuring heart valve annuluses for valve replacement
US9629717B2 (en) 2001-10-11 2017-04-25 Edwards Lifesciences Pvt, Inc. Prosthetic heart valve and method
US9919137B2 (en) 2013-08-28 2018-03-20 Edwards Lifesciences Corporation Integrated balloon catheter inflation system
US10022220B2 (en) 2000-04-06 2018-07-17 Edwards Lifesciences Corporation Methods of implanting minimally-invasive prosthetic heart valves
US10058425B2 (en) 2013-03-15 2018-08-28 Edwards Lifesciences Corporation Methods of assembling a valved aortic conduit
US10080653B2 (en) 2015-09-10 2018-09-25 Edwards Lifesciences Corporation Limited expansion heart valve
USD846122S1 (en) 2016-12-16 2019-04-16 Edwards Lifesciences Corporation Heart valve sizer
US10307249B2 (en) 2014-04-30 2019-06-04 Edwards Lifesciences Corporation Holder and deployment system for surgical heart valves
US10441415B2 (en) 2013-09-20 2019-10-15 Edwards Lifesciences Corporation Heart valves with increased effective orifice area
US10456246B2 (en) 2015-07-02 2019-10-29 Edwards Lifesciences Corporation Integrated hybrid heart valves
US10456245B2 (en) 2016-05-16 2019-10-29 Edwards Lifesciences Corporation System and method for applying material to a stent
US10463485B2 (en) 2017-04-06 2019-11-05 Edwards Lifesciences Corporation Prosthetic valve holders with automatic deploying mechanisms
USD867594S1 (en) 2015-06-19 2019-11-19 Edwards Lifesciences Corporation Prosthetic heart valve
US10543080B2 (en) 2011-05-20 2020-01-28 Edwards Lifesciences Corporation Methods of making encapsulated heart valves
US10667904B2 (en) 2016-03-08 2020-06-02 Edwards Lifesciences Corporation Valve implant with integrated sensor and transmitter
US10695170B2 (en) 2015-07-02 2020-06-30 Edwards Lifesciences Corporation Hybrid heart valves adapted for post-implant expansion
US10722316B2 (en) 2013-11-06 2020-07-28 Edwards Lifesciences Corporation Bioprosthetic heart valves having adaptive seals to minimize paravalvular leakage
US10799353B2 (en) 2017-04-28 2020-10-13 Edwards Lifesciences Corporation Prosthetic heart valve with collapsible holder
USD908874S1 (en) 2018-07-11 2021-01-26 Edwards Lifesciences Corporation Collapsible heart valve sizer
US11007058B2 (en) 2013-03-15 2021-05-18 Edwards Lifesciences Corporation Valved aortic conduits
US11135057B2 (en) 2017-06-21 2021-10-05 Edwards Lifesciences Corporation Dual-wireform limited expansion heart valves
US11337805B2 (en) 2018-01-23 2022-05-24 Edwards Lifesciences Corporation Prosthetic valve holders, systems, and methods
US11554012B2 (en) 2019-12-16 2023-01-17 Edwards Lifesciences Corporation Valve holder assembly with suture looping protection
US11690709B2 (en) 2015-09-02 2023-07-04 Edwards Lifesciences Corporation Methods for securing a transcatheter valve to a bioprosthetic cardiac structure
US12201734B2 (en) 2017-10-13 2025-01-21 Edwards Lifesciences Corporation Method for sterilizing heart valves
US12311095B2 (en) 2023-11-29 2025-05-27 Edwards Lifesciences Corporation Multi-lumen cannulae

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0073624A1 (fr) * 1981-08-24 1983-03-09 McNeilab, Inc. Procédé pour préparer un tissu pour valvules du coeur
EP0084395B1 (fr) * 1982-01-20 1986-08-13 Martin Morris Black Valvules cardiaques artificielles
EP0125393B1 (fr) * 1980-11-03 1987-12-09 Shiley Incorporated Prothèse de valvule cardiaque
EP0179562B1 (fr) * 1984-09-28 1989-07-12 The University of Glasgow, University Court Prothèse de valvule cardiaque
EP0155245B1 (fr) * 1984-03-16 1990-05-02 SORIN BIOMEDICA S.p.A. Prothèse de valvule cardiaque avec des lamelles de tissus biologiques

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0125393B1 (fr) * 1980-11-03 1987-12-09 Shiley Incorporated Prothèse de valvule cardiaque
EP0073624A1 (fr) * 1981-08-24 1983-03-09 McNeilab, Inc. Procédé pour préparer un tissu pour valvules du coeur
EP0084395B1 (fr) * 1982-01-20 1986-08-13 Martin Morris Black Valvules cardiaques artificielles
EP0155245B1 (fr) * 1984-03-16 1990-05-02 SORIN BIOMEDICA S.p.A. Prothèse de valvule cardiaque avec des lamelles de tissus biologiques
EP0179562B1 (fr) * 1984-09-28 1989-07-12 The University of Glasgow, University Court Prothèse de valvule cardiaque

Cited By (127)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5449385A (en) * 1991-05-08 1995-09-12 Nika Health Products Limited Support for a heart valve prosthesis
US5716399A (en) * 1995-10-06 1998-02-10 Cardiomend Llc Methods of heart valve repair
US6129758A (en) * 1995-10-06 2000-10-10 Cardiomend Llc Products and methods for circulatory system valve repair
US6945997B2 (en) 1997-03-27 2005-09-20 Edwards Lifesciences Corporation Heart valves and suture rings therefor
US6102944A (en) * 1997-03-27 2000-08-15 Edwards Lifesciences Corporation Methods of tissue heart valve assembly
US6585766B1 (en) 1997-03-27 2003-07-01 Edwards Lifesciences Corporation Cloth-covered stents for tissue heart valves
US8518108B2 (en) 1997-03-27 2013-08-27 Edwards Lifesciences Corporation Contoured heart valve suture rings
US6598307B2 (en) 1999-11-17 2003-07-29 Jack W. Love Device and method for assessing the geometry of a heart valve
US10022220B2 (en) 2000-04-06 2018-07-17 Edwards Lifesciences Corporation Methods of implanting minimally-invasive prosthetic heart valves
US6869444B2 (en) * 2000-05-22 2005-03-22 Shlomo Gabbay Low invasive implantable cardiac prosthesis and method for helping improve operation of a heart valve
US9439762B2 (en) 2000-06-01 2016-09-13 Edwards Lifesciences Corporation Methods of implant of a heart valve with a convertible sewing ring
US10238486B2 (en) 2000-06-01 2019-03-26 Edwards Lifesciences Corporation Heart valve with integrated stent and sewing ring
US6425902B1 (en) 2001-05-04 2002-07-30 Cardiomend Llc Surgical instrument for heart valve reconstruction
US11123182B2 (en) 2001-10-11 2021-09-21 Edwards Lifesciences Pvt, Inc. Prosthetic heart valve and method
US9629717B2 (en) 2001-10-11 2017-04-25 Edwards Lifesciences Pvt, Inc. Prosthetic heart valve and method
US9937039B2 (en) 2001-10-11 2018-04-10 Edwards Lifesciences Pvt, Inc. Prosthetic heart valve and method
US11166810B2 (en) 2001-10-11 2021-11-09 Edwards Lifesciences Pvt, Inc. Implantable prosthetic valve
US10052203B2 (en) 2001-10-11 2018-08-21 Edwards Lifesciences Pvt, Inc. Prosthetic heart valve and method
US10595991B2 (en) 2002-12-20 2020-03-24 Medtronic, Inc. Heart valve assemblies
US8460373B2 (en) 2002-12-20 2013-06-11 Medtronic, Inc. Method for implanting a heart valve within an annulus of a patient
US9333078B2 (en) 2002-12-20 2016-05-10 Medtronic, Inc. Heart valve assemblies
US8747463B2 (en) 2003-08-22 2014-06-10 Medtronic, Inc. Methods of using a prosthesis fixturing device
US9155617B2 (en) 2004-01-23 2015-10-13 Edwards Lifesciences Corporation Prosthetic mitral valve
US10085836B2 (en) 2004-01-23 2018-10-02 Edwards Lifesciences Corporation Prosthetic mitral valve
US9730794B2 (en) 2004-01-23 2017-08-15 Edwards Lifesciences Corporation Prosthetic mitral valve
US10342661B2 (en) 2004-01-23 2019-07-09 Edwards Lifesciences Corporation Prosthetic mitral valve
US10130468B2 (en) 2005-05-24 2018-11-20 Edwards Lifesciences Corporation Replacement prosthetic heart valves
US10456251B2 (en) 2005-05-24 2019-10-29 Edwards Lifesciences Corporation Surgical methods of replacing prosthetic heart valves
US11284998B2 (en) 2005-05-24 2022-03-29 Edwards Lifesciences Corporation Surgical methods of replacing prosthetic heart valves
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US10667906B2 (en) 2008-11-25 2020-06-02 Edwards Lifesciences Corporation Methods of conformal expansion of prosthetic heart valves
US9314334B2 (en) 2008-11-25 2016-04-19 Edwards Lifesciences Corporation Conformal expansion of prosthetic devices to anatomical shapes
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ES2028611A6 (es) 1992-07-01
BR9204120A (pt) 1993-06-08
EP0532719A1 (fr) 1993-03-24
CA2080138A1 (fr) 1992-08-08
AU1261292A (en) 1992-09-07

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