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1. WO1997024082 - HEART VALVE REPLACEMENT USING FLEXIBLE TUBES

Publication Number WO/1997/024082
Publication Date 10.07.1997
International Application No. PCT/US1995/016872
International Filing Date 28.12.1995
Chapter 2 Demand Filed 18.07.1997
IPC
A61F 2/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
FFILTERS 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
2Filters 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
A61F 2/24 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
FFILTERS 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
2Filters 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
02Prostheses implantable into the body
24Heart valves
A61L 27/36 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27Materials for prostheses or for coating prostheses
36containing ingredients of undetermined constitution or reaction products thereof
CPC
A61F 2/0095
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
FFILTERS 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
2Filters 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
0095Packages or dispensers for prostheses or other implants
A61F 2/2412
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
FFILTERS 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
2Filters 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
02Prostheses implantable into the body
24Heart 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
2412with soft flexible valve members, e.g. tissue valves shaped like natural valves
A61L 2430/20
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
2430Materials or treatment for tissue regeneration
20for reconstruction of the heart, e.g. heart valves
A61L 27/3604
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27Materials for ; grafts or; prostheses or for coating ; grafts or; prostheses
36containing ingredients of undetermined constitution or reaction products thereof ; , e.g. transplant tissue, natural bone, extracellular matrix
3604characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
A61L 27/3629
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27Materials for ; grafts or; prostheses or for coating ; grafts or; prostheses
36containing ingredients of undetermined constitution or reaction products thereof ; , e.g. transplant tissue, natural bone, extracellular matrix
3604characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
3629Intestinal tissue, e.g. small intestinal submucosa
A61L 27/3645
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
27Materials for ; grafts or; prostheses or for coating ; grafts or; prostheses
36containing ingredients of undetermined constitution or reaction products thereof ; , e.g. transplant tissue, natural bone, extracellular matrix
3641characterised by the site of application in the body
3645Connective tissue
Applicants
  • COX, James, L. [US]/[US]
Inventors
  • COX, James, L.
Agents
  • KELLY, Patrick, D.
  • COX, Boyd, D.
Priority Data
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) HEART VALVE REPLACEMENT USING FLEXIBLE TUBES
(FR) REMPLACEMENT DE VALVULE CARDIAQUE FAISANT APPEL A DES TUBES FLEXIBLES
Abstract
(EN)
This invention comprises a method of using tubular material (200) to replace a heart valve (118, 120, 162) during cardiac surgery. To create a replacement atrioventricular (mitral or tricuspid) valve (120, 160), the tube inlet is sutured to a valve annulus (121, 162) from which the native leaflets have been removed, and the tube outlet is sutured to papillary muscles (126, 128, 170) in the ventricle (112, 152). To create a semilunar (aortic or pulmonary) valve (118), the tube inlet is sutured to an annulus from which the native cusps have been removed, and the tube is either 'tacked' at three points distally inside the artery, or sutured longitudinally along three lines; this allows the flaps of tissue between the three fixation points at the valve outlet to function as movable cusps. These approaches generate flow patterns that closely duplicate the flow patterns of native valves. A preferred tubular material (200) comprises submucosal tissue from the small intestine; this can be taken from the same patient who is undergoing the cardiac operation, to reduce antigenicity. Animal or cadaver intestinal tissue can also be used if properly treated, or a biocompatible synthetic tubular material can be used. This invention also discloses a properly treated intestinal tissue segment or synthetic tubular segment (500) suitable for implantation as a replacement heart valve, enclosed in a sealed sterile package (510).
(FR)
Cette invention concerne un procédé faisant appel à un matériau tubulaire (200) afin de remplacer une valvule cardiaque (118, 120, 162) lors d'une opération de chirurgie cardiaque. Afin de créer une valvule atrio-ventriculaire (120, 160) mitrale ou tricuspide de remplacement, l'entrée du tube est suturée à un anneau (212, 162) de valvule dont on a enlevé les valves originelles, tandis que la sortie du tube est suturée aux muscles papillaires (126, 128, 170) dans le ventricule (112, 152). Afin de créer une valvule aortique ou pulmonaire (118) en forme de demi-lune, l'entrée du tube est suturée à un anneau dont on a enlevé les valves originelles et le tube est soit fixé en trois points distalement à l'intérieur de l'artère, soit suturé longitudinalement le long de trois lignes, ce système permettant aux volets de tissu situés entre les trois points de fixation au niveau de la sortie de la valvule de fonctionner comme des valves mobiles. Ces procédés permettent de générer des modes de débit qui imitent avec précision ceux de valvules originelles. Le matériau tubulaire (200) préféré consiste en un tissu prélevé sous la muqueuse de l'intestin grêle, lequel tissu peut être prélevé chez le patient qui subit l'opération du coeur de manière à limiter les risques d'antigénicité. Des tissus intestinaux d'animaux ou de cadavres peuvent également être utilisés du moment qu'ils ont été traités de manière adéquate, de même qu'un matériau tubulaire synthétique et biocompatible. Cette invention concerne également un segment de tissu intestinal traité de manière adéquate, ou encore un segment tubulaire synthétique (500), lesquels peuvent être utilisés en transplantation afin de remplacer une valvule cardiaque, et sont scellés dans une emballage stérile (510).
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