BRMU8903120Y1 - Implantable prostatic valve - Google Patents

Implantable prostatic valve Download PDF

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Publication number
BRMU8903120Y1
BRMU8903120Y1 BRMU8903120-2U BRMU8903120U BRMU8903120Y1 BR MU8903120 Y1 BRMU8903120 Y1 BR MU8903120Y1 BR MU8903120 U BRMU8903120 U BR MU8903120U BR MU8903120 Y1 BRMU8903120 Y1 BR MU8903120Y1
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Brazil
Prior art keywords
frame
valve
struts
prosthetic valve
leaflets
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BRMU8903120-2U
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English (en)
Inventor
Hariton Ilia
Benichou Netanel
Nitza Yaacov
Felsen Bella
Nguyen - Thien - Nh Diana
Khanna Rajesh
Nguyen Son
Levi Tamir
Pelled Itai
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Edwards Lifesciences Corporation
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Application filed by Edwards Lifesciences Corporation filed Critical Edwards Lifesciences Corporation
Publication of BRMU8903120U2 publication Critical patent/BRMU8903120U2/pt
Publication of BRMU8903120Y1 publication Critical patent/BRMU8903120Y1/pt
Publication of BRMU8903120Y8 publication Critical patent/BRMU8903120Y8/pt

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/243Deployment by mechanical expansion
    • A61F2/2433Deployment by mechanical expansion using balloon catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2475Venous valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B1/00Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means
    • B05B1/14Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means with multiple outlet openings; with strainers in or outside the outlet opening
    • B05B1/18Roses; Shower heads
    • B05B1/185Roses; Shower heads characterised by their outlet element; Mounting arrangements therefor
    • EFIXED CONSTRUCTIONS
    • E03WATER SUPPLY; SEWERAGE
    • E03CDOMESTIC PLUMBING INSTALLATIONS FOR FRESH WATER OR WASTE WATER; SINKS
    • E03C1/00Domestic plumbing installations for fresh water or waste water; Sinks
    • E03C1/02Plumbing installations for fresh water
    • E03C1/025Water supply lines as such, e.g. shower hoses
    • EFIXED CONSTRUCTIONS
    • E03WATER SUPPLY; SEWERAGE
    • E03CDOMESTIC PLUMBING INSTALLATIONS FOR FRESH WATER OR WASTE WATER; SINKS
    • E03C1/00Domestic plumbing installations for fresh water or waste water; Sinks
    • E03C1/02Plumbing installations for fresh water
    • E03C1/06Devices for suspending or supporting the supply pipe or supply hose of a shower-bath
    • E03C1/066Devices for suspending or supporting the supply pipe or supply hose of a shower-bath allowing height adjustment of shower head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522Means for mounting a stent or stent-graft onto or into a placement instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining
    • Y10T29/49863Assembling or joining with prestressing of part

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Hydrology & Water Resources (AREA)
  • Water Supply & Treatment (AREA)
  • Prostheses (AREA)
  • External Artificial Organs (AREA)

Abstract

patente de modelo de utilidade: válvula cardíaca transcateter de baixo perfil.o presente modelo de utilidade refere-se a válvula prostética impíantável, de acordo com uma concretização, que compreende uma arma- ção, uma estrutura de foliolos e um membro de saia. a armação pode ter uma pluralidade de escoras axiais interconectadas por uma pluralidade de escoras circunferenciais. a estrutura de foliolos compreende uma pluralidade de foliolos (por exemplo, trés foliolos dispostos para formar uma válvula tricúspide). a estrutura de foliolos apresenta uma porção de borda inferior recortada presa na armação. o membro de saia pode ser disposto entre a estrutura de foliolos e a armação.

Description

Relatório Descritivo da Patente de Modelo de Utilidade para "VÁLVULA PROSTÉTICA IMPLANTÁVEL".
CAMPO O presente modelo de utilidade refere-se a dispositivos implan-táveis e, mais particularmente, a próteses de válvula para implante em dutos do corpo, tais como anéis de válvula cardíaca nativa.
DESCRIÇÃO DA TÉCNICA RELACIONADA O coração humano pode sofrer de várias doenças valvulares. Estas doenças valvulares podem resultar em um mau funcionamento significativo do coração e, em última análise, exigem a substituição da válvula nativa por uma válvula artificial. Há inúmeras válvulas artificiais conhecidas e inúmeros métodos conhecidos de implantar estas válvulas artificiais em seres humanos. Várias técnicas cirúrgicas podem ser usadas para reparar uma válvula doente ou lesionada. Em uma operação de substituição de válvula, os folíolos lesionados são extirpados e o anel esculpido para receber uma válvula substituta. Devido à estenose aórtica e a outras doenças de válvula cardíaca, milhares de pacientes são submetidos a cirurgias a cada ano, em que a válvula cardíaca nativa defeituosa é substituída por uma válvula pros-tética, seja bioprostética ou mecânica. Outro método menos drástico para tratar válvulas defeituosas é através da reparação ou da reconstrução, que é tipicamente usada em válvulas minimamente calcificadas. O problema com a terapia cirúrgica é o trauma significativo que ela impõe sobre estes pacientes cronicamente doentes com altas taxas de morbidade e mortalidade associadas com a reparação cirúrgica.
Quando da substituição da válvula, o implante cirúrgico da válvula prostética tipicamente exige uma cirurgia de peito aberto durante a qual o coração é parado e o paciente é mantido em uma circulação extracorpórea ("máquina de coração-pulmão" assim chamada). Em um procedimento cirúrgico comum, os folíolos doentes da válvula nativa doente são extirpados e uma válvula prostética é suturada no tecido circundante no anel da válvula. Devido ao trauma associado com o procedimento e a consequente duração da circulação de sangue extracorpórea, alguns pacientes não sobrevivem ao procedimento cirúrgico ou morrem logo em seguida. É bem conhecido que o risco para o paciente aumenta com a quantidade de tempo exigida na circulação extracorpórea. Devido a estes riscos, um número substancial de pacientes com válvulas defeituosas é considerado inoperável porque sua condição é delicada demais para suportar o procedimento. Por meio de algumas estimativas, mais de 50% das pessoas com mais de 80 anos que sofrem de estenose aórtica não podem ser operadas para a substituição da válvula aór-tica.
Por causa das desvantagens associadas com a cirurgia de coração aberto convencional, abordagens cirúrgicas percutâneas e minimamente invasivas estão ganhando muita atenção. Em uma técnica, uma válvula prostética é configurada para ser implantada em um procedimento muito menos invasivo por meio de cateterização. Por exemplo, as Patentes U.S. Nos. 5.411.522 e 6.730.118, que são aqui incorporadas para referência, descrevem válvulas cardíacas transcateteres retráteis que podem ser percu-taneamente introduzidas em um estado comprimido em um cateter e expandidas na posição desejada por insuflação de balão ou pela utilização de uma armação ou stent autoexpansível.
Um parâmetro de desenho importante de uma válvula cardíaca transcateter é o diâmetro do perfil dobrado ou enrugado. O diâmetro do perfil enrugado é importante porque ele influencia diretamente a habilidade do médico em avançar a válvula através da artéria ou veia femoral. Mais particularmente, um perfil menor permite o tratamento de uma população mais ampla de pacientes, com uma maior segurança.
SUMÁRIO A presente descrição é dirigida a aparelhos e a métodos novos e não óbvios relacionados a válvulas prostéticas, tais como válvulas cardíacas.
Em uma concretização representativa, uma válvula prostética implantável compreende uma armação radialmente retrátil e expansível, ou stent, e uma estrutura de folíolos compreendendo uma pluralidade de folío-los. A estrutura de folíolos apresenta uma porção de borda inferior recortada que é posicionada dentro da armação e presa na mesma. A válvula pode adicionalmente incluir um membro de saia anular, que pode ser disposto entre a armação e a estrutura de folíolos de tal modo que a porção de borda inferior recortada possa ser conectada à superfície interna do membro de saia. Cada folíolo pode ter uma borda superior, uma borda inferior curvada e duas abas laterais se estendendo entre respectivas extremidades da borda superior e da borda inferior, onde cada aba lateral é presa em uma aba lateral adjacente de outro folíolo para formar comissuras da estrutura de folíolos. Cada comissura pode ser conectada a um dos postes de conexão de comis-sura, e uma barra de reforço pode ser posicionada contra cada aba lateral para reforçar as conexões entre as comissuras e os postes de conexão de comissura. A armação pode compreender uma pluralidade de escoras axiais angularmente espaçadas que é interconectada por uma pluralidade de fileiras de escoras circunferenciais. Cada fileira de escoras circunferenciais inclui desejavelmente escoras dispostas em um padrão em ziguezague ou na forma de dente de serra que se estende em torno da circunferência da armação.
Em certas concretizações, pelo menos uma fileira, e preferivelmente todas as fileiras, de escoras circunferenciais incluem pares de escoras circunferenciais que se estendem entre duas escoras axiais. Cada escora do par apresenta uma extremidade conectada a uma respectiva escora axial e outra extremidade interconectada a uma extremidade adjacente da outra escora do mesmo par por uma porção de coroa, de tal modo que haja uma abertura entre as extremidades adjacentes das escoras. O ângulo entre as escoras de cada par desejavelmente está entre cerca de 90 e 110 graus, com cerca de 100 graus sendo um exemplo específico. A armação é desejavelmente formada de uma liga à base de níquel-cobalto, tal como uma liga de molibdênio de níquel-cobalto-cromo (por exemplo, MP35N™).
Em outra concretização representativa, uma válvula prostética implantável compreende uma armação anular radialmente retrátil e expansí-vel e uma estrutura de folíolos sustentada pela armação. A armação pode compreender uma pluralidade de escoras interconectadas definindo uma pluralidade de células abertas na armação. A válvula adicionalmente inclui um membro de cobertura anular disposto sobre as células de pelo menos uma porção da armação e cobrindo as mesmas. O membro de cobertura desejavelmente compreende um elastômero, tal como silicone, que poderá se expandir e estirar, quando a válvula for expandida de um estado enrugado para um estado expandido. O membro de cobertura pode ser uma luva fina de silicone que circunda pelo menos uma porção da armação. Alternativamente, o membro de cobertura pode ser formado com a imersão de pelo menos uma porção da armação em silicone ou outro elastômero adequado na forma liquefeita.
Em outra concretização representativa, é descrito um método para enrugar uma válvula prostética implantável apresentando uma armação e folíolos sustentados pela armação. O método compreende a colocação da válvula na abertura de enrugamento de um dispositivo de enrugar, de tal modo que um material compressível seja disposto entre as garras de enrugar do dispositivo de enrgamento e a armação da válvula. É aplicada pressão contra o material compressível e a válvula com as garras de enrugar para radialmente enrugar a válvula em um perfil menor e comprimir o material compressível contra a válvula de tal modo que o material compressível se estenda para as células abertas da armação e empurre os folíolos de dentro da armação.
As características e vantagens do modelo de utilidade apresentadas anteriormente, bem como outras, se tomarão evidentes a partir da seguinte descrição detalhada, que procede com referência às figuras anexas.
BREVE DESCRIÇÃO DOS DESENHOS A figura 1 é uma vista em perspectiva de uma concretização representativa de uma válvula cardíaca prostética. A figura 2 é outra vista em perspectiva da válvula prostética da figura 1. A figura 3 é outra vista em perspectiva da válvula prostética da figura 1. A figura 4 é uma vista ampliada de uma seção da válvula mostrada na figura 3. A figura 5 é uma vista em perspectiva inferior da válvula prostéti-ca da figura 1 mostrando o lado de dentro da válvula. A figura 6 é uma vista plana de topo da válvula prostética da figura 1. A figura 6A é uma vista superior parcial ampliada da válvula da figura 1 ilustrando o posicionamento das barras de reforço com relação aos postes de conexão de comissura da armação. A figura 7 é uma vista em perspectiva da armação da válvula prostética da figura 1. A figura 8 é uma vista em perspectiva de uma concretização alternativa de uma armação que pode ser usada na válvula prostética da figura 1. A figura 9 é uma vista achatada do segmento de 120 graus da armação mostrada na figura 7. A figura 10 é uma vista achatada do segmento de 120 graus da armação mostrada na figura 8. A figura 11 é uma vista frontal de uma barra de reforço que pode ser usada para reforçar a conexão dos folíolos de válvula a uma armação em uma válvula prostética, tal como mostrada na figura 1. A figura 12 é uma vista em perspectiva da barra de reforço da figura 11 e da luva PET que pode ser usada para cobrir a barra. A figura 13 é uma vista achatada de um folíolo da válvula mostrada na figura 1. A figura 14 é uma vista achatada do lado oposto do folíolo que mostra uma tira de reforço presa adjacente à borda inferior do folíolo. A figura 15 é uma vista plana de topo da estrutura de folíolos da válvula da figura 1 antes da conexão à armação. A figura 16 é uma vista achatada da saia suada na válvula mostrada na figura 1. A figura 18 é uma vista em perspectiva inferior da estrutura de folíolos conectada à saia de modo a formar a montagem de folíolo. A figura 19 é uma vista lateral de um cateter de balão e de uma válvula prostética enrugada no balão do cateter de balão. A figura 20 é uma vista frontal de um dispositivo de enrugar que mostra uma válvula prostética posicionada na abertura de enrugamento do dispositivo de enrugar com uma luva protetora disposta entre a válvula e as garras de enrugar. A figura 21 é uma vista frontal do dispositivo de enrugar mostrado depois de as garras de enrugar serem forçadas para dentro para comprimir a válvula e a luva protetora. A figura 22 é uma vista lateral da válvula e da luva protetora a-pós a remoção do dispositivo de enrugamento. A figura 23 é uma vista lateral de uma válvula prostética que foi enrugada em um balão de um cateter de balão sem uma luva protetora. A figura 24 é uma vista lateral de uma válvula prostética que foi enrugada em um balão de um cateter usando uma luva protetora na maneira mostrada nas figuras 20-21. A figura 25 é uma vista lateral de uma armação para uma válvula prostética apresentando uma saia de silicone, ou luva, disposta no lado de fora da armação. A figura 26 é uma vista lateral de uma armação para uma válvula prostética apresentando uma camada de encapsulação de silicone que cobre o lado de dentro e o lado de fora da armação. A figura 27 é uma vista em perspectiva de uma válvula prostética que compreende uma armação apresentando uma camada de encapsulação de silicone. A figura 28 é uma vista em perspectiva da válvula da figura 27 após ter sido enrugada em um diâmetro menor. A figura 29 é uma vista lateral da válvula da figura 27 após ter sido expandida por um cateter de balão.
As figuras 30A-30C são gráficos que ilustram os resultados dos respectivos testes uniaxiais executados nas respectivas trias de teste de sili- cone.
As figuras 31A-31F são gráficos que ilustram os resultados dos respectivos testes uniaxiais executados nas respectivas tiras de teste de silicone apresentando rasgos deliberadamente introduzidos.
DESCRIÇÃO DETALHADA
As figuras 1 e 2 ilustram uma válvula prostética implantável 10, de acordo com uma concretização. A válvula 10 na concretização ilustrada compreende em geral uma armação, ou stent, 12, uma estrutura de folíolos 14 sustentada pela armação, e uma saia 16 presa à superfície externa da estrutura de folíolos. A válvula 10 é tipicamente implantada no anel da válvula aórtica nativa, mas pode também ser adaptada para ser implantada em outras válvulas nativas do coração ou em vários outros dutos ou orifícios do corpo. A válvula 10 apresenta uma extremidade "inferior" 80 e uma extremidade "superior" 82. No contexto do presente pedido, os termos "inferior" e "superior" são usados intercambiavelmente com os termos "influxo" e "escoamento", respectivamente. Desse modo, por exemplo, a extremidade inferior 80 da válvula está em sua extremidade de influxo e a extremidade superior 82 da válvula está em sua extremidade de escoamento. A válvula 10 e a armação 12 são configuradas para serem radialmente retráteis para um estado dobrado ou enrugado para introdução no corpo em um cateter de dispensa e radialmente expansível para um estado expandido para implantar a válvula em uma localização desejada no corpo (por exemplo, a válvula aórtica nativa). A armação 12 pode ser formada de um material plasticamente expansível que permite o enrugamento da válvula em um perfil menor para a dispensa e a expansão da válvula usando um dispositivo de expansão, tal como o balão de um cateter de balão. Materiais exemplificativos plasticamente expansíveis que podem ser usados para formar a armação são descritos abaixo. Alternativamente, a válvula 10 pode ser uma válvula autoexpansível assim chamada onde a armação é formada de um material autoexpansível, tal como Nitinol. Uma válvula autoexpansível pode ser enrugada em um perfil menor e mantida no estado enrugado com dispositivo de limitação, tal como um revestimento que cobre válvula. Quan- do a válvula estiver posicionada no local alvo ou próximo ao mesmo, o dispositivo de limitação será removido para permitir que a válvula seja autoex-pandida para seu tamanho funcional expandido.
Com referência também à figura 7 (que mostra a armação sozinha para fins de ilustração), a armação 12 é uma estrutura anular semelhante a um stent apresentando uma pluralidade de postes de conexão de co-missura angularmente espaçados e verticalmente estendidos, ou escoras, 18. Os postes 18 podem ser interconectados com uma fileira inferior 36a de escoras se estendendo circunferencialmente 20 e com uma primeira e uma segunda fileiras superioras 36b, 36c, respectivamente, de escoras que se estendem circunferencialmente 22 e 24, respectivamente. As escoras em cada fileira são desejavelmente dispostas em um padrão em ziguezague ou geralmente na forma de serra se estendendo na direção da circunferência da armação, conforme mostrado. Escoras adjacentes na mesma fileira podem ser interconectadas entre si, conforme mostrado nas figuras 1 e 5 para formar um ângulo A que está desejavelmente entre cerca de 90 e 110, com cerca de 100 graus sendo um exemplo específico. A seleção do ângulo A entre aproximadamente 90 e 110 graus irá otimizar a resistência radial da armação 12, quando expandida, ainda permitindo que a armação 12 seja uniformemente enrugada e então expandida na maneira descrita abaixo.
Na concretização ilustrada, pares de escoras circunferencialmente adjacentes na mesma fileira são conectados entre si por uma respectiva estrutura de coroa geralmente na forma de U, ou porção de coroa, 26. As estruturas de coroa 26 incluem cada qual uma porção horizontal se estendendo entre as extremidades adjacentes das escoras e conectando as mesmas, de tal modo que uma abertura 28 seja definida entre as extremidades adjacentes da estrutura de coroa conecta as extremidades adjacentes em uma localização deslocada a partir do ponto de interseção natural da escora. As estruturas de coroa 26 significativamente reduzem os esforços residuais na armação 12 na localização das escoras 20, 22, 24 durante o enrugamento e a expansão da armação 20 na maneira descrita abaixo. Cada par de escoras 22 conectado em uma estrutura de coroa comum 26 for- ma uma célula com um par adjacente de escoras 24 na fileira acima. Cada célula pode ser conectada a uma célula adjacente em um nó 32. Cada nó 32 pode ser interconectado com a fileira inferior de escoras por uma respectiva escora vertical (axial) 30 que será conectada e se estenderá entre um respectivo nó 32 e uma localização na fileira inferior de escoras 20, quando duas escoras forem conectadas em suas extremidades opostas às estruturas de coroa 26.
Em certas concretizações, as escoras inferiores 20 apresentam uma maior espessura ou diâmetro do que as escoras superiores 22, 24. Em uma implementação, por exemplo, escoras inferiores 20 apresentam uma espessura T (figura 9) de cerca de 0,42 mm e escoras superiores 22, 24 a-presentam uma espessura T de cerca de 0,38 mm. Pelo fato de haver apenas uma única fileira de escoras inferiores 20 e duas fileiras de escoras superiores 22, 24 na configuração ilustrada, o alargamento das escoras inferiores 20 com relação às escoras superiores 22, 24 intensifica a resistência radial da armação na área inferior da armação e permite uma expansão mais uniforme de armação. A figura 9 mostra uma vista achatada de um segmento de 120 graus da armação 12 mostrada na figura 7, o segmento compreendendo uma porção da armação se estendendo entre seus postes 18. Conforme mostrado, o segmento da armação apresenta três colunas 34 e três fileiras 36a, 36b, 36c de escoras por segmento. Cada coluna 34 é definida pelos pares contíguos de escoras 20, 22, 24 que se estendem entre duas escoras que se estendem axialmente 18, 30. A armação 12 é desejavelmente compreendida de três segmentos de 120 graus, com cada segmento sendo ligado por dois postes 18. Consequentemente, a armação 12 na concretização ilustrada inclui um total de 9 colunas por armação. O número de colunas e fileiras é desejavelmente minimizado para reduzir todo o perfil de enrugamento da válvula, conforme adicionalmente discutido abaixo. A disposição das figuras 7 e 9 é tipicamente usada para válvulas que têm menos de cerca de 29 mm de diâmetro, e são mais adequadas para válvulas que têm cerca de 20-26 mm de diâmetro. Em exem- pios de trabalho de válvulas compreendendo a armação 12, uma válvula de 20 mm pode ser enrugada em um diâmetro de cerca de 17 Fr, uma válvula de 23 mm pode ser enrugada em um diâmetro de cerca de 18 Fr e uma válvula de 26 mm pode ser enrugada em um diâmetro de cerca de 19 Fr. Para válvulas que têm cerca de 29 mm de diâmetro e maiores, pode ser desejável acrescentar outra fileira e coluna de escoras.
Por exemplo, as figuras 8 e 10 mostram uma armação alternativa 40 que é similar à armação 12, exceto pelo fato de a armação 40 apresentar quatro fileiras de escoras (uma primeira fileira mais inferior 52a de escoras 42, uma segunda fileira 52b de escoras 44, uma terceira fileira 52c de escoras 46, e uma fileira mais superior 52d de escoras 48) em vez de três fileiras de escoras, bem como quatro colunas 50 de escoras para cada segmento de armação de 120 graus em vez de três colunas de escoras. A figura 10 mostra uma vista achatada de um segmento de 120 graus da armação 40 mostrada na figura 8. A armação 40 na concretização ilustrada inclui três segmentos de 120 graus, provendo no total 12 colunas 50 de escoras par a armação.
As escoras 46 da terceira fileira são desejavelmente viradas na direção oposta das escoras 48 da quarta fileira (isto é, os ápices ou as porções de coroa estão viradas na direção oposta), para ajudar a impedir a deformação dos postes verticais da armação durante o enrugamento e a expansão da válvula. As escoras 44 da segunda fileira podem ser dispostas de modo a ficarem viradas na mesma direção que as escoras 42 da primeira fileira, conforme mostrado (isto é, os ápices ou as porções de coroa estão viradas na mesma direção). Alternativamente, as escoras 44 da segunda fileira podem ficar viradas na direção oposta a partir das escoras 42 da primeira fileira de modo a formarem células quadradas, como as células formadas pelas escoras 46, 38 da terceira e da quarta fileiras, respectivamente. A armação 40 pode também incluir escoras que se estendem axialmente 54 conectadas e se estendendo entre as extremidades de cada escora 42, 44, 46, 48 alinhadas em uma coluna 50 que não são conectadas a um poste 18. Conforme notado acima, a armação 40 é mais adequada para as válvulas de 29 mm e maiores de diâmetro (quando expandidas para seu tamanho funcional). E um exemplo de trabalho de uma válvula que incorpora a armação 40, uma válvula de 29 mm pode ser enrugada em um diâmetro de cerca de 21 Fr.
Materiais plasticamente expansíveis adequados que podem ser usados para formar a armação incluem, sem limitação, o aço inoxidável, uma liga à base de níquel (por exemplo, uma liga de níquel-cobalto-cromo), polímeros, ou combinações dos mesmos. Em concretizações específicas, tal como MP35N™ (nome comercial de SPS Technologies), que é equivalente a UNS R30035 (coberto por ASTM F562-02). MP35N™/UNS R30035 compreende 35% de níquel, 35% de cobalto, 20% de cromo, e 10% de molibdênio em peso. Foi descoberto que o uso de MP35N para formar a armação 20 fornece resultados estruturais superiores sobre o aço inoxidável. Em particular, quando MP35N for usado como o material de armação, menos material será necessário para conseguir o mesmo desempenho ou um desempenho melhor na resistência de força radial ou à compressão, resistências à fadiga, e resistência à corrosão. Além disso, uma vez que menos material é exigido, o perfil enrugado da armação pode ser reduzido, provendo assim uma montagem de válvula de baixo perfil para dispensa percutânea na localização de tratamento no corpo.
Com referência novamente à figura 1, a saia 16 pode ser formada, por exemplo, de fita de tereftalato de polietileno (PET). A espessura da saia pode variar, mas é desejavelmente menor do que 6 mil, e desejavel-mente menor do que 4 mil, e ainda mais desejavelmente de cerca de 2 mil. A saia 16 pode ser presa no lado de dentro da armação 12 através de suturas Lenzing 56, conforme mostrado na figura 1. A estrutura de folíolos 14 pode ser conectada à saia através de uma tira de reforço PET fina 68 (ou luva), discutida abaixo, que permite uma sutura fixa e protege o tecido pericardial da estrutura de folíolos contra rasgos. A estrutura de folíolos 14 pode ser sanduichada entre a saia 16 e a tira PET fina 68, conforme mostrado. A sutura 58, que prende a tira PET e a estrutura de folíolos 14 na saia 16, pode ser qualquer sutura adequada, tal como uma sutura Ethibond. A sutura 58 desejavelmente trilha a curvatura da borda inferior da estrutura de folíolos 14, conforme descrito em maiores detalhes abaixo. A estrutura de folíolos 14 pode ser formada de tecido pericardial bovino, materiais sintéticos biocom-patíveis, ou vários outros materiais naturais ou sintéticos, conforme conhecido na técnica e descritos na Patente Norte-americana No. 6.730. 118, que é aqui incorporada para referência. A estrutura de folíolos 14 pode compreender três folíolos 60, que podem ser dispostos para se romperem em uma disposição tricúspide, conforme melhor mostrado nas figuras 2 e 6. A borda inferior da estrutura de folíolos 14 desejavelmente apresenta uma forma recortada curvada ondulada (linha de sutura 58 mostrada na figura 1 trilha a forma recortada da estrutura de folíolos). Com a formação dos folíolos com esta geometria recortada, tensões sobre os folíolos são reduzidas, o que, por sua vez, aperfeiçoa a durabilidade da válvula. Além disso, em virtude da forma recortada, dobras e ondulações na saliência de cada folíolo (a região central de cada foliolo), que podem causar a calcificação prematura nessas áreas, podem ser eliminadas ou pelo menos minimizadas. A geometria recortada também reduz a quantidade de material de tecido usada para formar a estrutura de folíolos, permitindo assim um perfil menor ainda mais enrugado na extremidade de influxo da válvula.
Os folíolos 60 podem ser presos entre si em seus lados adjacentes para formar comissuras 84 da estrutura de folíolos (as bordas onde os folíolos se juntam). A estrutura de folíolos 14 pode ser presa à armação 12 usando técnicas e mecanismos adequados. Por exemplo, conforme melhor mostrado na figura 6, as comissuras 84 da estrutura de folíolos são desejavelmente alinhadas com os postos de suporte 18 e presas nos mesmos u-sando suturas. O ponto de conexão dos folíolos aos postes 18 pode ser reforçado com barras 62 (figura 11), que são desejavelmente formadas de um material relativamente rígido (em comparação aos folíolos), tal como aço inoxidável. A figura 13 mostra um único folíolo 60, que apresenta uma borda inferior curvada 64 e duas abas 66 se estendendo entre a borda superior e a borda inferior curvada do folíolo. A borda inferior curvada 64 forma um único recorte. Quando presas a dois outros folíolos para formar a estrutura de fo-líolos 14, as bordas inferiores curvadas dos folíolos coletivamente formam a porção de borda inferior formada recortada da estrutura de folíolos (conforme melhor mostrado na figura 18). Conforme adicionalmente mostrado na figura 13, duas barras de reforço 62 podem ser presas ao folíolo adjacente às abas 66 (por exemplo, usando suturas). As abas podem ser então dobradas sobre as barras 62 e presas na posição dobradas usando suturas. Caso desejado, conforme mostrado na figura 12, cada barra 62 pode ser colocada em uma luva protetora 68 (por exemplo, uma luva PET) antes de ser presa a um folíolo.
Conforme mostrado na figura 14, a borda curvada inferior 64 do folíolo pode ser reforçada para fixação posterior à saia 16, tal como com a fixação de uma tira de reforço 68 ao longo da borda inferior curvada entre as abas 66 na lateral das barras opostas de folíolo 62. Estes tais folíolos 60 podem ser preparados da mesma maneira e então conectados entre si em suas abas 66 em uma disposição tricúspide para formar a estrutura de folíolos 14, conforme mostrado na figura 15. As tiras de reforço 68 nos folíolos definem coletivamente uma fita ou luva que se estende ao longo da porção de borda inferior da superfície interna da estrutura de folíolos.
Conforme notado acima, a estrutura de folíolos 14 pode ser presa na armação 12 com a saia 16. A saia 16 desejavelmente compreende um material rijo resistente ao rasgo, tal como PET, embora vários outro materiais sintéticos ou naturais possam ser usados. A saia 16 pode ser muito mais fina do que as saias tradicionais. Em uma concretização, por exemplo, a saia 16 é uma saia PET apresentando uma espessura de cerca de 0,07 mm em suas bordas e de cerca de 0,06 mm em seu centro. A saia mais fina pode prover melhores desempenhos de enrugamento enquanto ainda provê uma boa vedação perivalvular. A figura 16 mostra uma vista achatada da saia antes de as extremidades opostas serem presas entre si para formarem a forma anular mostrada na figura 17. Conforme mostrado, a borda superior da saia 16 de- sejavelmente apresenta uma forma ondulada que segue geralmente a forma da segunda fileira de escoras 22 da armação. Desta maneira, a borda inferior da saia 16 pode ser estanquemente presa nas escoras 22 com suturas 56 (conforme melhor mostrado na figura 1). A saia 16 pode ser também formada com fendas 70 para facilitar a conexão da saia à armação. As fendas 70 ficarão alinhadas com as estruturas de coroa 26 das escoras 22, quando a saia for presa na armação. As fendas 70 são dimensionadas de modo a permitirem que uma porção de borda superior da saia seja parcialmente envolta em torno das escoras 22 e a reduzirem as tensões na saia durante o procedimento de conexão. Por exemplo, na concretização ilustrada, a saia 16 é colocada no lado de dentro da armação 12 e uma porção de borda superior da saia é envolta em torno das superfícies superiores das escoras 22 e prensada no lugar com suturas 56. O envolvimento da porção de borda superior da saia em torno das escoras 22 provê assim uma conexão mais resistente e mais durável da saia à armação. Embora não mostrado, a borda inferior da saia pode ser formada para se conformar geralmente ao contorno da fileira mais baixa de escoras 22 para aperfeiçoar o fluido de sangue além da extremidade de influxo da válvula.
Conforme adicionalmente mostrado na figura 17, várias linhas de sutura podem ser acrescentadas à saia para facilitar a conexão da saída à estrutura de folíolos e à armação. Por exemplo, uma linha de sutura formada recortada 72 pode ser usada como uma guia para suturar a borda inferior da estrutura de folíolos na localização adequada contra a superfície interna da saída suando a sutura 59 (conforme melhor mostrado na figura 5). Outra linha de sutura formada recortada 74 (figura 17) pode ser usada como uma guia para suturar a estrutura de folíolos à saia usando suturas 58 (figura 1). Tiras de reforço 68 presas na borda inferior dos folíolos reforçam os folíolos ao longo da linha de sutura 58 e protegem contra o rasgo dos folíolos. Afigura 18 mostra uma montagem de folíolo compreendida da saída 16 e da estrutura de folíolos 14 presa na saia. A montagem de folíolo pode ser então presa na armação 12 na maneira descrita abaixo. Nas concretizações alternativas, a saia, sem a estrutura de folíolos, pode ser conectada à primeira armação, e depois a estrutura de folíolos pode ser conectada à saia. A figura 6 mostra uma vista de topo da montagem de válvula conectada à armação 12. Os folíolos 60 são mostrados em uma posição geralmente fechada. Conforme mostrado, as comissuras dos folíolos são alinhadas com os postes 18 da armação. Os folíolos podem ser presos na armação usando suturas que se estendem através de abas 66 dos folíolos, aberturas 76 nas barras 62, e aberturas 78 nos postes 18, efetivamente prendendo as abas 66 aos postes 18. Conforme notado acima, as barras 62 reforçam as abas na área de conexão com postes e protegem contra o rasco dos folíolos.
Conforme mostrado na figura 6A, as barras 62 desejavelmente são alinhadas perpendiculares e tão retas quanto possível com relação aos postes 18 da armação, de tal modo que as barras 62 e o posto 18 em cada comissura formem uma forma "T". A largura das barras 62 e a conexão das comissuras através das barras apresentam um vão livre entre as porções deflectíveis dos folíolos 60 (as porções não presas por suturas à armação) e a armação, enquanto que o raio de borda (espessura) das barras 62 serve como uma articulação flexível para os folíolos durante a abertura e o fechamento da válvula, aumentando assim o espaço entre os folíolos e a armação. Com o aumento do espaço entre as porções móveis dos folíolos e a armação e em apresentando os folíolos flexíveis contra um raio de borda das barras 62, o contato entre as porções móveis dos folíolos (especialmente as bordas de escoamento dos folíolos) e a armação pode ser evitado durante os ciclos de trabalho, o que, por sua vez, aperfeiçoa a durabilidade da montagem de válvula. Esta configuração aumenta também a perfusão através de cavidades coronárias. A figura 19 representa uma vista lateral de uma válvula 10 enrugada em um cateter de dispensa de balão 100. A válvula é enrugada no balão 110 do cateter de balão 110. É desejável proteger a estrutura de folíolos 14 da válvula contra danos durante o enrugamento para assegurar a durabilidade da estrutura de folíolos, sendo, ao mesmo tempo, desejável reduzir tanto quanto possível o tamanho do perfil enrugado da válvula. Durante o procedimento de enrugamento, o tecido da estrutura de folíolos (por exemplo, tecido pericardial bovino ou outro tecido adequado) é pressionado conta a superfície interna da armação de metal e porções do tecido podem se projetar para as células abertas da armação entre as escoras e podem ser pin-çadas devido ao movimento semelhante à tesoura das escoras da armação. Se a válvula for severamente enrugada para alcançar um tamanho de enrugamento pequeno, este movimento semelhante a tesoura pode resultar em cortes e na ruptura dos folíolos de tecido. A saia 16, descrita acima, pode, até certo ponto, ser uma proteção contra danos à estrutura de folíolos durante o enrugamento. Entretanto, a finalidade principal da saia é estrutural e não cobre, em certas concretizações, toda a armação. Por isso, em tais concretizações, a saia pode não proteger completamente a estrutura de folíolos durante o enrugamento, podendo ainda assim a armação causar danos à estrutura de folíolos.
As figuras 20 e 21 mostram uma concretização de um aparelho de enrugar para o enrugamento atraumático de uma válvula em um balão em uma maneira que adicionalmente proteja contra danos aos folíolos. O aparelho de enrugar (também referido como um enrugador), indicado geralmente em 200, apresenta uma abertura 202 dimensionada para receber uma válvula em um estado expandido. A figura 20 mostra a abertura 202 em um estado totalmente aberto ou dilatado com uma válvula 10 posicionada dentro da abertura 202. O aparelho de enrugar 200 apresenta uma pluralidade de garras agarradoras 206 (12 na concretização ilustrada) que são configuradas para se moverem radialmente para dentro para comprimir radialmente (enrugar) a válvula para um perfil menor em torno do balão de um cateter de balão.
Um material deformável é posicionado entre o lado de fora da armação e as garras de agarramento 206. Na concretização ilustrada, o material deformável compreende uma luva protetora, ou cobertura, 204 que é colocada em torno da válvula de modo que ela cubra a superfície externa da armação da válvula e impeça que a superfície dura das garras de enrugar entre em contato direto com a armação da válvula. A luva 204 é desejável- mente dimensionada para cobrir por completo a superfície externa da armação. A luva 204 é desejavelmente formada de um material macio, flexível e compressível. A luva pode ser formada de materiais geralmente disponíveis, incluindo, mas não limitados à esponja natural ou sintética (por exemplo, esponja de poliuretano), uma material espumoso feito de um polímero adequado, tal como poliuretano ou polietileno, ou qualquer dos vários materiais elastoméricos adequados, tal como poliuretano, silicone, poliolefinas ou uma variedade de hidrogéis, só para citar alguns. A luva é desejavelmente armazenada em um ambiente úmido (por exemplo, imersa em salina) antes do uso. Depois de colocar a luva 204 em torno da válvula, a válvula e a luva são colocadas em aberturas de enru-gamento 200, conforme mostrado na figura 20. O balão 110 de um cateter de balão pode ser então posicionado dentro dos folíolos 60 da válvula (figura 21). A figura 21 mostra garras agarradoras 206 que circundam a luva 204, que, por sua vez, circunda a armação 12 e a estrutura de folíolos 14 da válvula 10. O balão 110 tipicamente é colocado no conector da válvula de modo que a válvula possa ser uniformemente expandida durante o implante da válvula dentro do corpo.
Conforme visto na figura 21, durante o enrugamento, o material semelhante à esponja da luva protetora 204 se projeta para as células abertas da armação 12 e ocupa este espaço, impedindo assim que a estrutura de folíolos 14 entre neste espaço e seja pinçada ou de outro modo lesionada. Depois de completo o enrugamento, a válvula com a luva protetora é removida do aparelho de enrugar. A luva 204 pode então ser suavemente desprendida da armação. Devido ao fato de a luva protetora pressionar a estrutura de folíolos para dentro e para longe da armação durante o enrugamento, a válvula pode ser enrugada em um perfil pequeno sem danificar a estrutura de folíolos.
As figuras 23 e 24 ilustram uma vantagem que pode ser obtida com o uso da luva protetora 204. A figura 23 mostra uma válvula prostética que foi enrugada sem usar a luva protetora. A linha pontilhada 300 identifica uma área da válvula onde a estrutura de folíolos 302 foi pressionada entre as escoras de uma armação 304, que pode danificar a estrutura de folíolos, conforme discutido acima.
Em contraste, a figura 24 mostra uma válvula prostética que foi enrugada usando a luva protetora 204. Neste exemplo, a estrutura de folíolos 302 foi pressionada para dentro e para longe do lado de dentro da armação 304, e, por isso, a estrutura de folíolos não foi pinçada ou comprimida entre as escoras da armação.
Consequentemente, uma vez que a estrutura de folíolos é pressionada para longe da armação, quando do uso da luva protetora, haverá menos probabilidade de a estrutura de folíolos ser pinçada ou cortada durante o processo de enrugamento. Também, quando do uso de uma luva protetora, uma estrutura muito ordenada de balão-folíolos-armação (de dentro para fora) poderá ser conseguida. Quando da não utilização de tal luva protetora, muito provavelmente uma certa porção do balão, dos folíolos, e da armação ficará sobreposta depois do procedimento de enrugamento, sendo menos previsível e uniforme a estrutura resultante.
Além da luva protetora de espuma ou do tipo esponja descrita acima, outros tipos de luvas ou camadas protetoras de material deformável poderão ser usados para proteger os folíolos conta danos durante o enrugamento de uma válvula. Em uma implementação, por exemplo, uma camada (por exemplo, fatias retangulares) de material deformável (por exemplo, esponja, borracha, silicone, poliuretano, etc.) pode ser disposta em cada garra de enrugar 206 de modo a formar uma luva em torno da válvula com o enrugamento. Alternativamente, pacotes deformáveis cheios de um material deformável fluido, tal como gel ou gás, podem ser dispostos em cada garra de enrugar para o contato da válvula com o enrugamento, Além disso, o material deformável (por exemplo, a luva 204) pode ser coberto com um pano PET fino, entre muitos outros materiais de tecido ou outros materiais adequados, para impedir que partículas dos materiais deformáveis migrem para a válvula durante o enrugamento. A saia de uma válvula prostética cumpre diversas funções. Em concretizações específicas, por exemplo, saia funciona para vedar e impedir (ou diminuir) o vazamento perivalvular, para fixar a estrutura de folíolos na armação, e para proteger os folíolos contra danos causados pelo contato com a armação durante o enrugamento e durante os ciclos de trabalho da válvula. A saia usada com a válvula prostética discutida acima foi descrita como sendo um tecido, tal como um pano PET. PET ou outros tecidos são substancialmente não-elásticos (isto é, substancialmente não estiráveis e não compressíveis). Desse modo, a saia, em certas implementações, limita o menor diâmetro de enrugamento alcançável da válvula e pode encolher depois da expansão a partir do diâmetro enrugado.
Em concretizações alternativas, conforme discutido abaixo, uma válvula prostética pode ser provida com uma saia que é formada de material estirável e/ou compressível, tal como silicone. Devido à compressibilidade de tal saia, a válvula pode ser enrugada em um diâmetro relativamente menor, como em comparação a uma válvula que apresenta uma saia não compressível. Adicionalmente, tal saia pode recuperar suas superfícies lisas originais com pouco ou nenhuma prega depois da expansão a partir do estado enrugado. A figura 25 mostra uma concretização de uma armação 12 que apresenta uma saia de "overtube" ou luva 340 que se estende completamente em torno e cobre pelo menos uma porção do lado de fora da armação. Em concretizações específicas, a saia 340 é formada de silicone, que pode sofrer grandes deformações enquanto mantém sua elasticidade. Tal saia de silicone pode ser uma luva fina que cobre uma porção da armação 12 a partir do lado de fora. Na concretização ilustrada, a altura da saia é menor do que toda a altura da armação 12; contudo, a saia pode variar na altura e não precisa ser da altura mostrada na figura 25. Por exemplo, a altura da saia pode ser igual ou maior do que aquela da armação, de modo a cobrir por completo o lado de fora da armação. Em uma concretização alternativa, a saia 340 pode ser montada no lado de dentro da armação usando, por e-xemplo, suturas ou um adesivo. Quando montada dentro da armação, a saia poderá proteger os folíolos da abrasão contra o lado de dentro da armação. Outros materiais que podem ser usados para formar a saia ou a luva inclu- em, mas não são limitados a PTFE, ePTFE, poliuretano, poliolefinas, hidro-géis, materiais biológicos (por exemplo, pericárdio ou polímeros biológicos, tais como colágeno, gelatina ou derivativos de ácido hialurônico) ou combinações dos mesmo.
Em outra concretização, toda a armação ou uma porção da mesma pode ser imersa no material liquefeito (por exemplo, silicone líquido ou qualquer dos materiais descritos acima para formar a luva 340 que podem ser liquefeitos para revestimento por imersão da armação) a fim de en-capsular toda a armação (ou pelo menos essa porção que é imersa) em silicone. A figura 26 é uma vista lateral de uma armação 12 que foi imersa em silicone para formar uma cobertura de silicone cilíndrica contínua 342 que encapsula as escoras da armação e que preenche os espaços entre as escoras. A figura 26 mostra a cobertura 342 antes de ser desbastada para remover o excesso de material que se estende além das extremidades da armação. Embora menos desejável, a armação pode ser imersa de tal modo que o silicone encapsule as escoras da armação, mas não preencha os espaços abertos entre as escoras da armação. A figura 27 mostra uma concretização de uma válvula prostética 400 compreendendo uma armação 402 e uma estrutura de folíolos 404 montada no lado de dentro da armação (por exemplo, usando suturas, conforme mostrado). A armação 402 apresenta uma saia na forma de cobertura de silicone 406 que é formada, por exemplo, por imersão da armação em silicone líquido. A figura 27 mostra a válvula 400 em seu estado expandido. Na figura 28, a válvula 400 foi enrugada em um perfil menor. Durante o enruga-mento, o revestimento 406, que se estende através e enche as células abertas entre as escoras da armação, é eficaz para pressionar a estrutura de folíolos 404 para dentro e para longe da armação, impedindo assim que a estrutura de folíolos seja pinçada ou rasgada. A figura 29 mostra a válvula 400 depois de ser expandida por um balão de um cateter de balão. A fim de testar a durabilidade e a resistência de estiramento do silicone usado, foram conduzidos vários testes uniaxiais. Em particular, tiras de silicone de cerca de 5x50 mm (com uma espessura de cerca de 0,85 mm) foram testadas em um aparelho de teste uniaxial. As figuras 30A-30C mostram gráficos dos resultados dos testes uniaxiais de tiras de silicone. Além disso, rasgos foram deliberadamente introduzidos nas tiras de silicone no meio das tiras e na borda das tiras enquanto as tiras eram estiradas em um aparelho de teste uniaxial. Os rasgos foram introduzidos em se fazendo furos nas tiras de silicone com uma agulha. As figuras 31A-31F mostram gráficos dos resultados dos testes uniaxiais de tiras de silicone com rasgos deliberadamente introduzidos.
Foi descoberto que o estiramento elástico final para uma camada fina de silicone foi além de 500%, e as amostras que tinham rasgos que foram deliberadamente introduzidos continuaram a mostrar uma resistência notável. Consequentemente, a elasticidade do silicone permite que armações imersas em silicone sejam enrugadas em perfis muito baixos e expandidas novamente em perfis maiores sem danos significativos à camada de silicone. Além disso, o material de silicone pode aumentar o atrito entre a armação e o anel nativo onde a válvula prostética é implantada, resultando em uma melhor fixação e impedindo/reduzindo os vazamentos perivalvula-res.
Uma saia de silicone pode ser montada em uma armação por vários meios, incluindo o uso de um mandril. Também, pode ser desejável usar uma saia de silicone em combinação com uma saia de pano ou tecido. Por exemplo, pode ser desejável colocar uma saia de silicone no lado de fora de uma saia de pano ou tecido que esteja circundando pelo menos uma porção de uma armação.
Alternativa ou adicionalmente, uma saia de silicone podería também ser colocada no lado de dentro da armação e conectada à armação, de modo a oferecer aos folíolos uma proteção aperfeiçoada durante os ciclos de trabalho, Alternativamente, em vez de silicone, a saia pode ser formada de um material auxético e/ou dilatável, tais como hidrogéis sintéticos ou naturais. Um material auxético é aquele que se expande lateralmente enquanto estirado longitudinalmente, o que significa que este material apresenta uma relação Poisson negativa. Se a armação for coberta com um material auxéti- co, ela poderá se expandir radialmente enquanto é estirada circunferencial-mente, quando a válvula for expandida de seu estado enrugado. Tal expansão pode aperfeiçoar o ajuste da válvula no anel de válvula nativa, impedindo ou reduzindo assim o vazamento perivalvular.
Em vista das muitas concretizações possíveis à qual podem ser aplicados os princípios do modelo de utilidade descrito, deve ser reconhecido que as concretizações ilustradas são apenas exemplos preferidos do modelo de utilidade e não devem ser tomadas como limitando o escopo do modelo de utilidade. Mais propriamente, o escopo do modelo de utilidade é i-dentificado pelas seguintes reivindicações. Por isso, o modelo de utilidade é reivindicado por tudo que está dentro do escopo e do espírito destas reivindicações.
REIVINDICAÇÕES

Claims (10)

1. Válvula prostética implantável (10) que compreende: uma armação anular radialmente retrátil e expansível (12), a armação apresentando três postes de conexão de comissura (18) e três fileiras de escoras circunferenciais se estendendo entre os postes de conexão de comissura (18), uma primeira fileira de escoras circunferenciais (20) definindo uma extremidade de influxo da armação e a segunda e a terceira fileiras de escoras circunferenciais (22, 24) espaçadas entre si a partir da primeira fileira adjacente a uma extremidade de escoamento da armação, a primeira fileira (20) conectada à segunda (22) e à terceira (24) fileiras por uma pluralidade de escoras axiais (30), cada fileira de escoras circunferenciais compreendendo escoras anguladas dispostas em um padrão em ziguezague e interconectadas; uma estrutura de folíolos (14) compreendendo três folíolos (60) formados de tecido pericárdico, cada folíolo (60) apresentando uma borda superior, uma borda inferior curvada (64) e duas abas laterais (66), onde cada aba lateral é presa em uma aba lateral adjacente de outro folíolo para formar comissuras (84) da estrutura de folíolos (14), cada comissura (84) sendo conectada a um dos postes de conexão de comissura (18); um membro de saia anular (16) posicionado entre a armação anular (12) e a estrutura de folíolos (14), a borda inferior curvada (64) de cada folíolo suturada em uma superfície interna do membro de saia ao longo de uma linha recortada (58); e um par de barras de reforço (62) posicionado adjacente a cada poste de conexão de comissura (18), em que a válvula prostética implantável (10) é caracterizada pelo fato de que: cada barra de reforço (62) compreendendo uma pluralidade de furos, onde cada aba lateral se estende em torno de uma barra de reforço e cada barra de reforço é suturada em um poste de conexão de comissura (18) para reforçar as conexões entre a estrutura de folíolo (14) e os postes de conexão de comissura (18), em que as escoras anguladas são interconectadas por uma estrutura de coroa geralmente na forma de U (26) para uma retratilidade aperfeiçoada .
2. Válvula prostética implantável (10), de acordo com a reivindicação 1, caracterizada pelo fato de que as comissuras (84) da estrutura de folíolos (14) são conectadas aos postes de conexões de comissura (18) com suturas que se estendem através das abas laterais (66), das barras de reforço (62) e dos postes de conexão de comissura (18).
3. Válvula prostética implantável (10), de acordo com a reivindicação 1, caracterizada pelo fato de que as escoras anguladas serão conectadas em ângulos (A) entre cerca de 90 e 110 graus, quando a armação anular estiver em um estado expandido.
4. Válvula prostética implantável (10), de acordo com a reivindicação 1, caracterizada pelo fato de que a armação compreende uma liga de níquel-cobalto-cromo.
5. Válvula prostética implantável (10), de acordo com a reivindicação 4, caracterizada pelo fato de que a liga de níquel-cobalto-cromo compreende MP35N.
6. Válvula prostética implantável (10), de acordo com a reivindicação 1, caracterizada pelo fato de que as escoras da primeira fileira (20) são mais espessas do que as escoras da segunda (22) e da terceira (24) fileiras.
7. Válvula prostética implantável (10), de acordo com a reivindicação 1, caracterizada pelo fato de que a armação anular é plasticamente expansível.
8. Válvula prostética implantável (10), de acordo com a reivindicação 1, caracterizada pelo fato de que cada uma das barras de reforço (62) apresenta quatro furos que correspondem a quatro furos formados em cada um dos postes de conexão de comissura (18).
9. Válvula prostética implantável (10), de acordo com a reivindicação 1, caracterizada pelo fato de que a primeira (20) e a segunda (22) fileiras de escoras circunferenciais apresentam padrões em ziguezague paralelos.
10. Válvula prostética implantável (10), de acordo com a reivindi- cação 9, caracterizada pelo fato de que o padrão em ziguezague da terceira fileira (24) de escoras circunferenciais é oposto ao da primeira (20) e da segunda (22) fileiras.
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