PT1259193E - Sistema de ancoragem para próteses de válvulas cardíacas implantáveis - Google Patents

Sistema de ancoragem para próteses de válvulas cardíacas implantáveis Download PDF

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Publication number
PT1259193E
PT1259193E PT01916903T PT01916903T PT1259193E PT 1259193 E PT1259193 E PT 1259193E PT 01916903 T PT01916903 T PT 01916903T PT 01916903 T PT01916903 T PT 01916903T PT 1259193 E PT1259193 E PT 1259193E
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Prior art keywords
heart valve
hook
valve prosthesis
shaped elements
elements
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PT01916903T
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English (en)
Inventor
Markus Ferrari
Hans-Reiner Figulla
Matthias Mohaupt
Carsten Weber
Christoph Damm
Klaus Lang
Stefan Risse
Volker Guyenot
Gerd Harnisch
Peggy Doerrer
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Jenavalve Technology Inc
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Publication of PT1259193E publication Critical patent/PT1259193E/pt

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    • 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
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

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  • 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)

Description

ΕΡ1259193Β1
DESCRIÇÃO
SISTEMA DE ANCORAGEM PARA PRÓTESES DE VÁLVULAS CARDÍACAS
IMPLANTÁVEIS A invenção refere-se a um sistema de ancoragem para próteses de válvulas cardíacas que são implantáveis através da aorta sem uma operação de dimensão considerável, enquanto uma operação convencional requer a abertura completa do tórax.
No passado, foram realizadas as mais variadas tentativas, e foram oferecidas soluções através das quais as próteses de válvula cardíaca foram passadas através da aorta até ao coração, onde foram implantadas de forma permanente após um processo de desdobramento ou espalhamento. É descrito um denominado "stent", inter alia, no documento US 5 855 601, ao qual pode ser fixada uma prótese de válvula cardíaca. O "stent" é substancialmente formado por um metal com memória de forma de tipo fio que possui uma configuração de malha e uma forma cilíndrica. O metal com memória de forma pode ser moldado a temperaturas abaixo dos 37°C e, no estado dobrado, é guiado por um cateter através da aorta do coração, onde, após desligar um mecanismo de arrefecimento quando é alcançada a temperatura de aproximadamente 37°C, adopta a forma memorizada e situa-se contra a parede interna da aorta no estado correspondentemente implantado. 1 ΕΡ1259193Β1
Contudo, devido aos limites do metal com memória de forma, um tal "stent" é simplesmente dificil de miniaturizar e dobrar de modo a que seja passado através da aorta sem problemas e, além disso, para possuir uma dimensão no estado implantado que permita que o "stent" se situe contra ele e seja retido com segurança na parede interior da aorta.
Além disso, o fabrico de um suporte de ancoragem concebido e construído deste modo e produzido de metal com memória de forma convencional (e.g., nitinol) adequado para o intervalo de temperatura necessário provoca problemas e envolve um custo de produção elevado correspondente porque um tal corpo é normalmente derivado de um material a granel por meio de core com raio laser. Na técnica anterior nos termos do Art. 54(3) EPC são revelados elementos em forma de gancho de ELGILOY.
Por isso, é um objecto da invenção propor uma possibilidade através da qual as próteses de válvulas cardíacas podem ser guiadas através da aorta para o coração, onde podem ser fixadas.
De acordo com a invenção, este objecto é alcançado com as características da reivindicação 1. Formas de realização vantajosas e outros desenvolvimentos da invenção são obtidos com as características definidas nas reivindicações dependentes.
De acordo com a invenção, elementos em forma de gancho são directamente fixados às comissuras de uma prótese de válvula cardíaca biológica, que pode ser retirada, por 2 ΕΡ1259193Β1 exemplo, a partir de um coração de porco, ou de uma prótese de válvula cardíaca artificial, cujos ganchos são guiados através do material da prótese de válvula cardíaca numa direcção para o exterior e, no estado implantado, penetrar na, ou através da, parede da aorta, respectivamente, de modo a que a prótese da válvula cardíaca possa ser colocada com segurança na parede da aorta.
Além disso, também podem ser atribuídos elementos em forma de gancho adicionais ao anel exterior da prótese da válvula cardíaca.
Ao mesmo tempo, os elementos em forma de gancho podem ser cosidos à prótese da válvula cardíaca.
Todavia, é mais fácil e menos complicado introduzir os elementos em forma de gancho na prótese da válvula cardíaca a partir de dentro e empurrar pelo menos os ganchos através da prótese da válvula cardíaca material, na qual é útil proporcionar os elementos em forma de gancho numa rede ou com um elemento base, que assegura que apenas os ganchos dos elementos em forma de gancho se projectam a partir da prótese de válvula cardíaca, enquanto que o resto é retido dentro da prótese da válvula cardíaca por um tamanho respectivo.
Uma rede pode possuir, por exemplo, a forma de uma barra lisa ou uma placa alongada, na qual são formados pelo menos dois elementos em forma de gancho.
Um elemento base pode ser, por exemplo, em forma de placa e circular, no qual a área transversal do círculo pode 3 ΕΡ1259193Β1 prevenir uma perfuração do material da prótese da válvula cardíaca.
Os elementos em forma de gancho, que são dispostos em redes ou elementos base, respectivamente, podem ser substancialmente em forma de pino, nos quais uma ou mais farpa é/são formadas na parte em forma de pino para serem ancorados na parede da aorta, que fica presa dentro ou atrás da parede da aorta após ter sido pressionada contra esta. A forma de farpa pode ser impressa num metal de memória de forma, de modo a que as farpas apenas ficam espetadas numa direcção para fora acima das temperaturas de transição, o que facilita a penetração para, e através, da parede da aorta.
Se forem utilizadas as redes onde são formados ou fixados os elementos em forma de gancho, eles podem ser atribuídos às comissuras de uma prótese da válvula cardíaca de modo a que estejam orientados na direcção longitudinal da aorta no estado implantado.
Todavia, pode ser também particularmente vantajoso conceber as redes de um modo helicoidal para que, devido à forma helicoidal, sejam adaptadas ao contorno interno da aorta e se situar directamente contra a aorta após a ancoragem por meio dos ganchos. Em consequência da forma helicoidal uma área circunferencial maior da parede interna da aorta é coberta, para que possa ser alcançado um grau de selagem mais elevado. 4 ΕΡ1259193Β1
Se forem utilizados elementos individuais em forma de gancho separados um do outro por elementos base, devem ser dispostos igualmente de um modo distribuído sobre as comissuras, em que também é possível um arranjo em hélice ou um arranjo de duas espirais em direcções opostas.
Se são utilizadas redes com elementos em forma de gancho, estas redes devem possuir um comprimento que é pelo menos tão grande como o comprimento das comissuras da prótese da válvula cardíaca.
As redes atribuídas a comissuras diferentes não estão ligadas uma à outra.
Além disso, para introduzir a prótese da válvula cardíaca com o sistema de ancoragem atribuído a ela, é favorável se pelo menos os elementos em forma de gancho forem produzidos de um metal com memória de forma, que assegura que os elementos em forma de gancho permaneçam planos durante a fase de introdução e que são obtidos apenas uma pequena resistência de introdução e um pequeno volume, e que a forma desejada seja adoptada e os próprios ganchos fiquem ancorados na parede da aorta apenas no local da implantação após o arrefecimento ter sido desligado. A altura eficaz dos elementos em forma de gancho deve ser então pelo menos 2 mm, para que se projectem nesta altura da prótese da válvula cardíaca e penetrem para dentro ou através da parede da aorta, respectivamente. 5 ΕΡ1259193Β1
Além disso, é vantajoso dobrar os ganchos dos elementos diferentes em forma de gancho em várias direcções de modo a obter uma fixação segura do sistema de ancoragem inventivo, tendo em conta também as condições na aorta, a pressão e as condições de fluxo que prevalecem na proximidade do coração.
Vantajosamente, os elementos adjacentes em forma de gancho podem ser dobrados com uma orientação um em direcção ao outro, ou que uma tal posição possa ser impressa quando é utilizado um metal com memória de forma. Após atingir ou exceder a temperatura de transição isto implica que os elementos adjacentes em forma de gancho estão interligados na parede da aorta.
Além disso, pode ser atribuído um elemento anelar adicional dentro da prótese da válvula cardíaca na área do seu anel exterior, o que pode igualmente ser pressionado juntamente durante a fase de introdução através da aorta e precisa de um volume mais pequeno. Para esta finalidade, pode ser utilizado um material elástico, e. g., um material plástico ou borracha adequados, se forem fornecidos apropriadamente com uma mola helicoidal, ou também uma mola helicoidal isoladamente ou um metal com memória de forma. A prótese da válvula cardíaca fornecida com o sistema de ancoragem de acordo com a invenção pode ser introduzida na aorta por meio de um cateter no qual é fornecido um mecanismo correspondente, em que o mecanismo deve assegurar o desenvolvimento da prótese da válvula cardíaca e a libertação da prótese da válvula cardíaca quando colocada na posição desejada. 6 ΕΡ1259193Β1
Contudo, também pode ser utilizado um cateter de balão, no qual a prótese da válvula cardíaca fornecida com o sistema de ancoragem de acordo com a invenção pode ser puxada sobre o cateter e é introduzida nesta posição na aorta. Quando o local da implantação é alcançado, o balão é pressurizado e a prótese da válvula cardíaca é pressionada com os elementos em forma de gancho contra a parede da aorta, e os ganchos podem ser então ancorados na parede da aorta. Se for utilizado um metal com memória de forma, o cateter de balão também pode ser utilizado para o arrefecimento necessário. A superfície do balão desse cateter pode ter os contornos correspondentes, de modo a que o resultado da elasticidade do balão e o contorno correspondentemente formado das redes ou elementos base, respectivamente, são retidos com segurança na fase de introdução através da aorta, enquanto que este estado retido é libertado quando o balão é alargado.
Contudo, também pode ser utilizado um cateter possuindo um mecanismo de implantação automático que, novamente, é produzido de um metal com memória de forma, de modo a assegurar a atribuição da prótese da válvula cardíaca por meio do sistema de ancoragem de acordo com a invenção.
Em qualquer caso, no entanto, é útil envolver a prótese da válvula cardíaca na fase da introdução para evitar lesões indesejáveis da parede da aorta antes de alcançar o local da implantação e para, além disso, garantir uma insuflação térmica correspondente se for necessário arrefecimento. Após atingir o local da implantação este envolvimento pode ser 7 ΕΡ1259193Β1 destruído, ou pode ser activado um mecanismo de libertação, e removido da aorta com o cateter.
Se for utilizado um mecanismo de implantação de um metal com memória de forma, pode ser concebido, como foi mencionado anteriormente, como um elemento anelar que é atribuído à prótese da válvula cardíaca na área do seu anel exterior. Um tal elemento anelar pode então assegurar a estabilidade da prótese da válvula cardíaca implantada e uma função de selagem aumentada. A invenção será explicada mais pormenorizadamente abaixo através de uma forma de realização.
No desenho:
Figura 1 - mostra um exemplo de um sistema de ancoragem de acordo com a invenção numa prótese da válvula cardíaca.
No sistema de ancoragem inventivo exemplificativo para uma prótese da válvula cardíaca 1, tal como apresentado na
Figura 1, elementos em forma de gancho 2 são formados nas redes 3, e cada uma dessas redes 3 está disposta em e fixada numa comissura da prótese da válvula cardíaca 1.
Neste exemplo, ambas as redes 3 e os elementos em forma de gancho 2 são produzidos de um metal com memória de forma, que está disponível, por exemplo, sob a designação de nitinol. Para a finalidade de as fixar, as redes 3 são introduzidas na prótese da válvula cardíaca 1 a partir do 8 ΕΡ1259193Β1 interior e são simplesmente pressionadas através das comissuras da prótese da válvula cardiaca 1 de modo a que esta última seja perfurada. A forma apresentada na Figura 1 pode ser impressa no metal com memória de forma utilizado, cuja forma é adoptada após a temperatura de transição de 37°C ser excedida. Na fase de introdução da prótese da válvula cardiaca 1 os elementos em forma de gancho 2 devem ser, todavia, preferencialmente inclinados aproximadamente 90° na direcção do eixo longitudinal das redes 3. Assim, requerem um volume relativamente pequeno e projectam-se apenas numa pequena extensão, que facilita a introdução e evita lesões da parede da aorta.
No exemplo apresentado, são formados cinco elementos em forma de gancho na rede 3. Todavia, deve ser utilizado um total de pelo menos quinze elementos em forma de gancho.
No entanto, o número dos elementos em forma de gancho 2 pode variar prontamente. Também, é possível atribuir várias dessas redes 3 com elementos em forma de gancho 2 a uma comissura da prótese da válvula cardíaca 1.
Contrariamente ao desenho, as redes 3 podem então possuir uma orientação que é inclinada num determinado ângulo, em que duas dessas redes 3 podem também ser inclinadas opostamente uma em relação à outra. 9 ΕΡ1259193Β1
De acordo com uma forma de realização não ilustrada pode ser atribuído um elemento anelar adicional à prótese da válvula cardíaca 1 na área do seu anel exterior 4.
Além disso, podem ser formadas farpas nos elementos em forma de gancho 2 ou nos seus ganchos, respectivamente, de modo a melhorar a ancoragem.
Lisboa, 6 de Janeiro de 2011 10

Claims (13)

  1. ΕΡ1259193Β1 REIVINDICAÇÕES 1. Prótese de válvula cardíaca implantável compreendendo um sistema de ancoragem, em que o sistema de ancoragem inclui vários elementos em forma de gancho (2) ou elementos em forma de gancho (2) com farpas e pelo menos um elemento base ou rede (3) por meio do qual os elementos em forma de gancho (2) ou os elementos em forma de gancho (2) com farpas são mantidos, em que os elementos em forma de gancho (2) ou os elementos em forma de gancho (2) com farpas são fixados pelo menos a uma comissura da prótese da válvula cardíaca (1), em que os elementos em forma de gancho (2) são guiados numa direcção para fora através do material da válvula cardíaca, e em que os elementos em forma de gancho (2) ou os elementos em forma de gancho (2) com farpas são produzidos de um metal com memória de forma e são adaptados para permanecerem planos durante a fase de introdução quando a prótese da válvula cardíaca (1) é implantada e ficam direitos assim que a temperatura de transição característica para o metal com memória de forma é atingido ou excedido.
  2. 2. Prótese de válvula cardíaca de acordo com a reivindicação 1, em que os elementos em forma de gancho (2) são cosidos à prótese da válvula cardíaca (1).
  3. 3. Prótese de válvula cardíaca de acordo com a reivindicação 1 ou 2, em que pelo menos dois elementos em forma de gancho (2) são dispostos num elemento base ou rede (3) .
  4. 4. Prótese de válvula cardíaca de acordo com a reivindicação 1 ou 2, em que vários elementos base ou redes 1 ΕΡ1259193Β1 (3) estão orientados na direcção longitudinal da prótese da válvula cardíaca.
  5. 5. Prótese de válvula cardíaca de acordo com a reivindicação 1, em que os elementos em forma de gancho (2) possuem uma altura eficaz de pelo menos 2 mm numa condição implantada, na qual se projectam da prótese de válvula cardíaca para serem ancoradas na parede da aorta.
  6. 6. Prótese de válvula cardíaca de acordo com a reivindicação 1, em que os elementos em forma de gancho (2) têm a forma de pinos e são dotados de farpas.
  7. 7. Prótese de válvula cardíaca de acordo com a reivindicação 1, em que as farpas dos elementos em forma de gancho (2) são dobradas em várias direcções.
  8. 8. Prótese de válvula cardíaca de acordo com a reivindicação 1, em que os elementos em forma de gancho (2) dentro da prótese da válvula cardíaca (1) são mantidos pelo menos num elemento base.
  9. 9. Prótese de válvula cardíaca de acordo com a reivindicação 3, em que vários elementos base são orientados na direcção longitudinal da prótese de válvula cardíaca.
  10. 10. Prótese de válvula cardíaca de acordo com a reivindicação 3, em que vários elementos base são concebidos de um modo helicoidal. 2 ΕΡ1259193Β1
  11. 11. Prótese de válvula cardíaca de acordo com a reivindicação 3, em que vários elementos base são pelo menos tão compridos como as comissuras.
  12. 12. Prótese de válvula cardíaca de acordo com uma das reivindicações anteriores, em que um elemento anelar é fornecido dentro da prótese da válvula cardíaca (1) na área do anel exterior.
  13. 13. Prótese de válvula cardíaca de acordo com a reivindicação 12, em que o elemento anelar é produzido de um material elástico ou metal com memória de forma. Lisboa, 6 de Janeiro de 2011 3
PT01916903T 2000-02-28 2001-02-28 Sistema de ancoragem para próteses de válvulas cardíacas implantáveis PT1259193E (pt)

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DE10010073A DE10010073B4 (de) 2000-02-28 2000-02-28 Verankerung für implantierbare Herzklappenprothesen

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EP (1) EP1259193B1 (pt)
JP (1) JP4246433B2 (pt)
AT (1) ATE488199T1 (pt)
CY (1) CY1111106T1 (pt)
DE (2) DE10010073B4 (pt)
DK (1) DK1259193T3 (pt)
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US11357624B2 (en) 2007-04-13 2022-06-14 Jenavalve Technology, Inc. Medical device for treating a heart valve insufficiency
US11589981B2 (en) 2010-05-25 2023-02-28 Jenavalve Technology, Inc. Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
US12171658B2 (en) 2022-11-09 2024-12-24 Jenavalve Technology, Inc. Catheter system for sequential deployment of an expandable implant
US12232957B2 (en) 2008-02-26 2025-02-25 Jenavalve Technology, Inc. Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US12433745B2 (en) 2017-01-27 2025-10-07 Jenavalve Technology, Inc. Heart valve mimicry
US12569336B2 (en) 2005-01-20 2026-03-10 Jenavalve Technology, Inc. Catheter system for implantation of prosthetic heart valves

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DE10010073B4 (de) 2005-12-22
US20070005129A1 (en) 2007-01-04
EP1259193B1 (de) 2010-11-17
JP2003524504A (ja) 2003-08-19
WO2001064137A1 (de) 2001-09-07
DE50115708D1 (de) 2010-12-30
DE10010073A1 (de) 2001-09-27
DK1259193T3 (da) 2011-01-31
EP1259193A1 (de) 2002-11-27
CY1111106T1 (el) 2015-06-11
ES2353733T3 (es) 2011-03-04
US7896913B2 (en) 2011-03-01
US20030149476A1 (en) 2003-08-07
ATE488199T1 (de) 2010-12-15
JP4246433B2 (ja) 2009-04-02

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