WO2022123099A1 - Fenestrated stent for artery repair, provided with a fenestration positioning guide - Google Patents

Fenestrated stent for artery repair, provided with a fenestration positioning guide Download PDF

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Publication number
WO2022123099A1
WO2022123099A1 PCT/ES2021/070876 ES2021070876W WO2022123099A1 WO 2022123099 A1 WO2022123099 A1 WO 2022123099A1 ES 2021070876 W ES2021070876 W ES 2021070876W WO 2022123099 A1 WO2022123099 A1 WO 2022123099A1
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Prior art keywords
fenestration
positioning guide
endograft
guide
repair
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PCT/ES2021/070876
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Spanish (es)
French (fr)
Inventor
Ciro BAEZA BERMEJILLO
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Fundación Instituto de Investigación Sanitaria Fundación Jiménez Díaz (FIIS-FJD)
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Publication of WO2022123099A1 publication Critical patent/WO2022123099A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts

Definitions

  • the present invention falls within the technical field of medical devices, and more specifically is related to fenestrated endoprostheses for the treatment of aneurysmal pathology of the aorta (EVAR).
  • EVAR aorta
  • An object of the invention is to provide an endoprosthesis or endograft that allows a perfect alignment of the fenestrations (holes) of an endoprosthesis with the respective arteries or bifurcations of arteries to be treated.
  • An additional object of the invention is to provide an endoprosthesis that simplifies the process for deploying endoprostheses within the aortic lumen, in order to reduce surgical intervention time, reduce radiation and iodinated contrast doses required, and reduce thus the risk of complications in the intervention.
  • the device object of the invention is especially applicable in urgent EVAR surgical interventions.
  • Endovascular repair is an effective way to treat aortic aneurysmal disease (EVAR).
  • EVAR aortic aneurysmal disease
  • the treatment of aneurysms that affect the outlet of arterial branches requires the use of alternative techniques such as the placement of chimney-shaped stents (ChEVAR) or, with more promising results, the use of fenestrated endoprostheses (FEVAR) that allow preservation of flow to the involved arteries.
  • ChoEVAR chimney-shaped stents
  • FEVAR fenestrated endoprostheses
  • the most critical and complex aspect of this procedure lies in achieving a correct alignment of the fenestrations with their respective target arteries. It is essential that the deployment of endoprostheses within the aortic lumen be as precise as possible, and this requires a high degree of manipulation of the devices within the arterial lumen, which can condition the development of a series of complications. In addition, they are techniques that require at least two vascular accesses to be carried out. On the other hand, the difficulty involved in performing these procedures means that surgical times, as well as the dose of radiation and iodinated contrast necessary, are high.
  • PMEGs include the need for the clinician to spend time modifying the endograft, the lack of industrial quality control after device modification, and the lack of a substantial body of evidence to support their use. Modification of commercially available devices by Physicians may void any assurances of safety by the manufacturer, and systematic evaluation of such devices is best done within an institutionally and/or regulatory approved protocol.
  • the present invention solves the aforementioned problem, by means of a guide for fenestrated endoprostheses, where the guide is shaped like a preferably metallic wire and has a closed hole at one of its ends, so that the guide can be used to precisely position a fenestration of a stent.
  • the positioning guide is factory pre-inserted into the fenestration of an endograft.
  • one aspect of the invention relates to a fenestrated stent for artery repair, comprising an endograft in the form of a tubular body suitable for placement within an artery.
  • the stent further comprises a positioning guide for each fenestration.
  • This guidewire is insertable through a fenestration of the tubular endograft, and is in the form of a wire or thread with a length greater than that of the endograft.
  • the positioning guide has a closed hole at one of its ends, which is intended for the passage of a second guide, also in the form of a wire, preferably the closed hole is dimensioned for passage through it and in the form adjusted, from a second guide with a diameter of 0.0889 millimeters (0.035”).
  • the closed hole can be made in any way.
  • the closed hole is obtained by bending part of the end of the positioning guide itself in the form of a loop.
  • the guide may be folded back on itself to form a slipknot.
  • the closed hole is made with part of the outer jacket folded in the form of a loop.
  • the positioning guide is made of a metallic material, preferably a shape-memory metallic material, such as radiopaque nitinol.
  • the locating guide has a diameter of 0.0889 millimeters (0.035").
  • Part of the positioning guide is housed within the endograft, and passes through a fenestration in the endograft to the outside of the endograft, such that the end with the closed hole is on the outside of the endograft.
  • the stent further comprises an introducer sheath with a tubular shape, such that the endograft is housed within the introducer sheath.
  • the sheath has a perimeter wall, an open rear end and a preferably conical-shaped closed front end, where the sheath has a first fenestration in the perimeter wall in proximity to the open end.
  • the positioning guide is arranged so that it runs inside the positioning sheath and inside the endograft, passing through the first fenestration of the sheath to the outside of the sheath, passes through the fenestration of the endograft to run between it and the positioning sleeve, and passes through the tapered end to the outside.
  • the device object of the invention simplifies these surgical interventions, and therefore makes them accessible to surgeons with less experience.
  • the inventive stent graft enables complex repairs in symptomatic or ruptured patients for whom custom-made stent grafts may not be readily available.
  • the invention allows the use of endoprostheses in emergency situations, since the fenestrations can be carried out by the surgeon himself, tailored to each patient.
  • Figure 1.- shows a schematic and perspective representation of the endograft of the invention.
  • Figure 2.- shows a pair of perspective views A, B of an enlarged detail of two ways of obtaining the closed hole at one end of the positioning guide.
  • Figure 3.- shows three schematic representations AC in perspective, of the endoprosthesis deployment process in an arterial vessel.
  • the fenestrated endoprosthesis (1) for the repair of arteries comprises an endograft (2) in the shape of a tubular body suitable for being placed inside an artery, and a positioning guide (3).
  • fenestration which is wire-shaped, preferably radiopaque nitinol, and longer than the endograft (2).
  • the endograft (2) has a fenestration (5) in its pehmetral wall, and the positioning guide (3) is placed inside the endograft (2) protrudes through the posterior mouth (17) of the same, passes through the fenestration (5) to run outside the endograft so that the free end of the guide (3) outside the endograft (2) has a closed hole (4), as shown in Figure 1.
  • the endoprosthesis (1) also has an introducer sheath (6) with a tubular shape, and which has a pehmetral wall, an open rear end and a closed front end (7) (preferably conical), and a fenestration (9 ) on the pehmetral wall in proximity to the open posterior end.
  • endograft (2) Inside the introducer sheath (6) the endograft (2) is housed, and a stop (10) of the release system housed in the back of the sheath (6), which allows the sheath (6) to go back without the graft. endograft (2) to move.
  • the positioning guide (3) is arranged so that it runs inside the sheath (6) and inside the endograft (2), runs through a slit (8) in the stop (10) and passes through the fenestration ( 9) of the sheath (6) towards the outside of the same.
  • the guide (3) passes through the fenestration (5) of the endograft (2) towards the outside to run between the endograft
  • a rigid guide (15) is passed through the interior of the endograft (2), as is usually done in conventional endoprostheses.
  • the closed hole (4) is obtained by bending part of the end of the positioning guide itself into a loop
  • the closed hole (4) is dimensioned for the passage through it and in a tight way, of a second guide (11) with a diameter of 0.0889 millimeters.
  • the closed hole (4) can be obtained by knotting the outer plastic jacket (12) that covers the guide (3) over itself, to form the closed hole, as shown in Figure 2B.
  • FIGS 3 A-C partially illustrate the cannulation technique of an arterial bifurcation (13) through a fenestrated endoprosthesis (1) in situ by the surgeon himself, for a single fenestration.
  • the procedure is carried out coaxially through a single access point, and in summary it consists of the following phases.
  • the guide (3) is advanced over an auxiliary guide (16) previously channeled into the target artery, by means of a balloon catheter (14) in the direction of the arrow (F1) until it reaches and remain lodged in the target artery ( Figure 3B).
  • the fenestrated endoprosthesis (1) is then introduced supported or guided on a rigid guide (15) as shown in Figure 3C, up to a height that coincides with the target artery, and correctly positioning the fenestration (5) of the endograft (2) .
  • a traction force is exerted on the positioning guide (3) to allow the progression of the endoprosthesis (1) that will be transmitted to the tip of the guide (3), which would cause its expulsion from the target artery (as indicated by the arrow F2).
  • the swollen balloon-catheter (14) abuts the ring that forms the closed hole (4) and exerts the same force in the opposite direction (as indicated by arrow F3), thus preventing the guidewire (3) from being expelled. of the target artery.
  • the device object of the invention has been described in a simplified way for a single fenestration, but it could be extended to its realization in as many arterial branches as appropriate.
  • the device object of the invention can not only be used in visceral arteries but could also be applied to TSA and in any arterial bifurcation.

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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)

Abstract

The present invention relates to a fenestrated stent for endovascular aneurysm repair (EVAR). The fenestrated stent comprises an endograft in the form of a tubular body suitable for placement inside an artery, and a fenestration positioning guide, wherein: the guide can be inserted through a fenestration of the tubular endograft; the guide is in the form of a wire that is longer than the endograft; and the guide comprises a closed hole at one end. The invention provides a stent or endograft that allows the stent fenestrations to be perfectly aligned with the respective arteries or arterial bifurcations to be repaired.

Description

ENDOPROTESIS FENESTRADA PARA REPARACION DE ARTERIAS, DOTADA DE GUIA DE POSICIONAMIENTO DE FENESTRACION FENESTRATED ENDOPROSTHESIS FOR ARTERY REPAIR, EQUIPPED WITH FENESTRATION POSITIONING GUIDE
D E S C R I P C I O N DESCRIPTION
Campo técnico y objeto de la invención Technical field and object of the invention
La presente invención se engloba dentro del campo técnico de los dispositivos médicos, y más concretamente es relativa a las endoprótesis fenestradas para el tratamiento de la patología aneurismática de la aorta (EVAR). The present invention falls within the technical field of medical devices, and more specifically is related to fenestrated endoprostheses for the treatment of aneurysmal pathology of the aorta (EVAR).
Un objeto de la invención, es el de proporcionar una endoprótesis o endoinjerto, que permita una perfecta alineación de las fenestraciones (orificios) de una endoprótesis con las respectivas arterias o bifurcaciones de arterias a tratar. An object of the invention is to provide an endoprosthesis or endograft that allows a perfect alignment of the fenestrations (holes) of an endoprosthesis with the respective arteries or bifurcations of arteries to be treated.
Un objeto adicional de la invención, es el de proporcionar una endoprótesis que simplifique el proceso para desplegar las endoprótesis dentro de la luz aórtica, con objeto de reducir el tiempo de intervención quirúrgica, reducir las dosis de radiación y de contraste yodado necesarias, y reducir de ese modo el riesgo de complicaciones en la intervención. An additional object of the invention is to provide an endoprosthesis that simplifies the process for deploying endoprostheses within the aortic lumen, in order to reduce surgical intervention time, reduce radiation and iodinated contrast doses required, and reduce thus the risk of complications in the intervention.
El dispositivo objeto de la invención, es especialmente aplicable en intervenciones quirúrgicas EVAR urgentes. The device object of the invention is especially applicable in urgent EVAR surgical interventions.
Estado de la técnica State of the art
La reparación endovascular es una forma eficaz de tratar la patología aneurismática de la aorta (EVAR). El tratamiento de los aneurismas que afectan a la salida de ramas arteriales, requiere el uso de técnicas alternativas como la colocación de stents en forma de chimeneas (ChEVAR) o, con resultados más prometedores, el uso de endoprótesis fenestradas (FEVAR) que permitan la preservación del flujo hacia las arterias implicadas. Éstas, son prótesis diseñadas a la medida del paciente, por lo que existe un periodo de demora en su producción, y no resultan accesibles en las intervenciones urgentes. Endovascular repair is an effective way to treat aortic aneurysmal disease (EVAR). The treatment of aneurysms that affect the outlet of arterial branches requires the use of alternative techniques such as the placement of chimney-shaped stents (ChEVAR) or, with more promising results, the use of fenestrated endoprostheses (FEVAR) that allow preservation of flow to the involved arteries. These are prostheses designed to suit the patient, so there is a period of delay in their production, and they are not accessible in urgent interventions.
El uso de estas endoprótesis es cada vez más común en el tratamiento endovascular de la aorta abdominal visceral, por lo que actualmente se considera el FEVAR como la estrategia de primera línea en estos casos, asociándose con un alto éxito técnico, una baja tasa de mortalidad operatoria, una alta tasa de permeabilidad de los vasos objetivo y una tasa aceptable de reintervención. The use of these endoprostheses is increasingly common in the endovascular treatment of the visceral abdominal aorta, which is why FEVAR is currently considered the first-line strategy in these cases, associated with high technical success, a low mortality rate surgery, a high target vessel patency rate, and an acceptable reoperation rate.
Sin embargo, el coste económico de un procedimiento endovascular puede variar entre 12.000€ y 40.000€. Además, los procedimientos FEVAR resultan más costosos que los procedimientos EVAR convencionales debido al coste adicional de los propios endoinjertos fenestrados y al aumento de la tasa de complicaciones relacionadas con el FEVAR. However, the economic cost of an endovascular procedure can vary between €12,000 and €40,000. In addition, FEVAR procedures are more expensive than conventional EVAR procedures due to the additional cost of the fenestrated endografts themselves and the increased rate of FEVAR-related complications.
Según los grupos con mayor experiencia en estas técnicas quirúrgicas, el aspecto más crítico y complejo de este procedimiento reside en lograr una correcta alineación de las fenestraciones con sus respectivas arterias objetivo. Es imprescindible que el despliegue de las endoprótesis dentro de la luz aórtica sea lo más preciso posible y esto requiere un alto grado de manipulación de los dispositivos dentro de la luz arterial, lo que puede condicionar el desarrollo de una serie de complicaciones. Además, son técnicas que requieren al menos dos accesos vasculares para poder llevarse a cabo. Por otra parte, la dificultad que supone realizar estos procedimientos, hace que los tiempos quirúrgicos, así como la dosis de radiación y de contraste yodado necesario, sean elevados. According to the groups with the greatest experience in these surgical techniques, the most critical and complex aspect of this procedure lies in achieving a correct alignment of the fenestrations with their respective target arteries. It is essential that the deployment of endoprostheses within the aortic lumen be as precise as possible, and this requires a high degree of manipulation of the devices within the arterial lumen, which can condition the development of a series of complications. In addition, they are techniques that require at least two vascular accesses to be carried out. On the other hand, the difficulty involved in performing these procedures means that surgical times, as well as the dose of radiation and iodinated contrast necessary, are high.
Por otra parte, hoy en día, se está popularizando el uso de endoinjertos modificados por el propio cirujano (PMEG) de forma artesanal sobre la misma mesa de quirófano. De este modo se puede abordar el tratamiento de este tipo de patologías cuando requieran una intervención urgente, lo que además supone una reducción del coste económico de la intervención quirúrgica. On the other hand, nowadays, the use of endografts modified by the surgeon himself (PMEG) in an artisanal way on the same operating room table is becoming popular. In this way, the treatment of this type of pathology can be addressed when they require an urgent intervention, which also means a reduction in the economic cost of the surgical intervention.
Las desventajas de los PMEG son la necesidad de que el médico dedique tiempo a modificar el endoinjerto, la falta de control de calidad industrial después de la modificación del dispositivo y la falta de un conjunto considerable de pruebas que apoyen su uso. La modificación de los dispositivos disponibles comercialmente por parte de los médicos puede anular cualquier garantía de seguridad por parte del fabricante, y la evaluación sistemática de dichos dispositivos se realiza mejor dentro de un protocolo aprobado a nivel institucional y / o regulatorio. Disadvantages of PMEGs include the need for the clinician to spend time modifying the endograft, the lack of industrial quality control after device modification, and the lack of a substantial body of evidence to support their use. Modification of commercially available devices by Physicians may void any assurances of safety by the manufacturer, and systematic evaluation of such devices is best done within an institutionally and/or regulatory approved protocol.
Los fundamentos técnicos en los que se apoyan las técnicas PMEG son, esencialmente, los mismos que los de los procedimientos FEVAR, por lo que resultan igual de complejos. A pesar del beneficio que pueden aportar el uso de modelos aórticos fabricados en impresoras 3D para ajustar la localización de las fenestraciones, la liberación de la endoprótesis siempre se puede ver afectada por errores en el alineamiento hacia los ostium de las arterias objetivo. Por lo tanto, la seguridad total para liberar estas prótesis sin que haya errores de alineamiento, solo se consigue si se mantiene una guía canulada hacia la arteria objetivo antes de haberse liberado la prótesis. The technical fundamentals on which the PMEG techniques are based are essentially the same as those of the FEVAR procedures, so they are just as complex. Despite the benefit of using 3D-printed aortic models to adjust the location of fenestrations, stent release can always be affected by misalignment with the ostia of the target arteries. Therefore, total safety in releasing these stents without misalignment is only achieved if a cannulated guidewire is maintained towards the target artery before the stent is released.
Detectamos pues, que en este campo técnico existe la necesidad de una técnica que disminuya la dificultad de estos procedimientos, que facilite la orientación correcta de las fenestraciones minimizando los riesgos y complicaciones del procedimiento, y haciendo además que la intervención quirúrgica resulte más segura, rápida, económica y eficaz. We therefore detect that in this technical field there is a need for a technique that reduces the difficulty of these procedures, that facilitates the correct orientation of the fenestrations, minimizing the risks and complications of the procedure, and also making the surgical intervention safer, faster , economical and effective.
Descripción de la invención Description of the invention
La presente invención soluciona la problemática anteriormente expuesta, mediante una guía para endoprótesis fenestrada, donde la guía tiene forma de alambre preferentemente metálico y dispone de un orificio cerrado en uno de sus extremos, de modo que la guía se puede utilizar para posicionar con precisión una fenestración de una endoprótesis. Preferentemente la guía de posicionamiento está pre-insertada de fábrica en la fenestración de un endoinjerto. The present invention solves the aforementioned problem, by means of a guide for fenestrated endoprostheses, where the guide is shaped like a preferably metallic wire and has a closed hole at one of its ends, so that the guide can be used to precisely position a fenestration of a stent. Preferably the positioning guide is factory pre-inserted into the fenestration of an endograft.
De manera más concreta, un aspecto de la invención se refiere a una endoprótesis fenestrada para la reparación de arterias, que comprende un endoinjerto con forma de cuerpo tubular adecuado para ser colocado dentro de una arteria. La endoprótesis además comprende una guía de posicionamiento para cada fenestración. Esta guía es insertable a través de una fenestración del endoinjerto tubular, y tiene forma de alambre o hilo con una longitud mayor que la del endoinjerto. Según la invención, la guía de posicionamiento dispone de un orificio cerrado en uno de sus extremos, el cual está destinado al paso de una segunda guía también en forma de alambre, preferentemente el orificio cerrado está dimensionado para el paso a su través y de forma ajustada, de una segunda guía con un diámetro de 0.0889 milímetros (0.035”). More specifically, one aspect of the invention relates to a fenestrated stent for artery repair, comprising an endograft in the form of a tubular body suitable for placement within an artery. The stent further comprises a positioning guide for each fenestration. This guidewire is insertable through a fenestration of the tubular endograft, and is in the form of a wire or thread with a length greater than that of the endograft. According to the invention, the positioning guide has a closed hole at one of its ends, which is intended for the passage of a second guide, also in the form of a wire, preferably the closed hole is dimensioned for passage through it and in the form adjusted, from a second guide with a diameter of 0.0889 millimeters (0.035”).
El orificio cerrado puede estar realizado de cualquier forma. En una realización preferente, el orificio cerrado está obtenido doblando en forma de lazo parte del extremo de la propia guía de posicionamiento. Por ejemplo, la guía puede estar doblada sobre sí misma formado un nudo corredizo. The closed hole can be made in any way. In a preferred embodiment, the closed hole is obtained by bending part of the end of the positioning guide itself in the form of a loop. For example, the guide may be folded back on itself to form a slipknot.
En otra realización preferente, el orificio cerrado está realizado con parte de la camisa exterior plegada en forma de lazo. In another preferred embodiment, the closed hole is made with part of the outer jacket folded in the form of a loop.
La guía de posicionamiento está realizada con un material metálico, preferentemente con un material metálico con memoria de forma, como por ejemplo nitinol radiopaco. The positioning guide is made of a metallic material, preferably a shape-memory metallic material, such as radiopaque nitinol.
Preferentemente, la guía de posicionamiento tiene un diámetro de 0.0889 milímetros (0.035”). Preferably, the locating guide has a diameter of 0.0889 millimeters (0.035").
Parte de la guía de posicionamiento está alojada dentro del endoinjerto, y pasa a través de una fenestración del endoinjerto hacia el exterior del mismo, de forma que el extremo con el orificio cerrado está en el exterior del endoinjerto. Part of the positioning guide is housed within the endograft, and passes through a fenestration in the endograft to the outside of the endograft, such that the end with the closed hole is on the outside of the endograft.
La endoprótesis además comprende una vaina introductora con forma tubular, de modo que el endoinjerto está alojado dentro de la vaina introductora. La vaina dispone de una pared perimetral, un extremo posterior abierto y un extremo frontal cerrado preferentemente con forma cónica, donde la vaina dispone de una primera fenestración en la pared perimetral en proximidad al extremo abierto. The stent further comprises an introducer sheath with a tubular shape, such that the endograft is housed within the introducer sheath. The sheath has a perimeter wall, an open rear end and a preferably conical-shaped closed front end, where the sheath has a first fenestration in the perimeter wall in proximity to the open end.
La guía de posicionamiento está dispuesta de forma que discurre por el interior de la vaina de posicionamiento y por el interior del endoinjerto, pasa por la primera fenestración de la vaina hacia el exterior de la misma, pasa por la fenestración del endoinjerto para discurrir entre el mismo y la vaina de posicionamiento, y pasa a través del extremo cónico hacia el exterior. The positioning guide is arranged so that it runs inside the positioning sheath and inside the endograft, passing through the first fenestration of the sheath to the outside of the sheath, passes through the fenestration of the endograft to run between it and the positioning sleeve, and passes through the tapered end to the outside.
El dispositivo objeto de la invención simplifica estas intervenciones quirúrgicas, y por lo tanto las hace accesibles a cirujanos con menos experiencia. The device object of the invention simplifies these surgical interventions, and therefore makes them accessible to surgeons with less experience.
Además, dadas las limitaciones de tiempo para la fabricación de injertos fenestrados personalizados, la endoprótesis objeto de la invención posibilita las reparaciones complejas en pacientes sintomáticos o con rotura, para quienes los endoinjertos hechos a medida pueden no estar disponibles de inmediato. La invención permite el uso de endoprótesis en situaciones de emergencia, ya que las fenestraciones las puede realizar el propio cirujano a la medida de cada paciente. In addition, given the time constraints for fabricating custom fenestrated grafts, the inventive stent graft enables complex repairs in symptomatic or ruptured patients for whom custom-made stent grafts may not be readily available. The invention allows the use of endoprostheses in emergency situations, since the fenestrations can be carried out by the surgeon himself, tailored to each patient.
Breve descripción de las figuras Brief description of the figures
Figura 1.- muestra una representación esquemática y en perspectiva del endoinjerto de la invención. Figure 1.- shows a schematic and perspective representation of the endograft of the invention.
Figura 2.- muestra un par de vistas A, B en perspectiva de un detalle ampliado de dos formas de obtener el orificio cerrado en un extremo de la guía de posicionamiento. Figure 2.- shows a pair of perspective views A, B of an enlarged detail of two ways of obtaining the closed hole at one end of the positioning guide.
Figura 3.- muestra tres representaciones esquemáticas A - C en perspectiva, del proceso de despliegue de la endoprótesis en un vaso arterial. Figure 3.- shows three schematic representations AC in perspective, of the endoprosthesis deployment process in an arterial vessel.
Realización preferente de la invención Preferred embodiment of the invention
A la vista de la Figura 1, puede apreciarse como la endoprótesis fenestrada (1 ) para la reparación de arterias, comprende un endoinjerto (2) con forma de cuerpo tubular adecuado para ser colocado dentro de una arteria, y una guía de posicionamiento (3) de fenestración, la cual tiene forma de alambre, preferentemente de nitinol radiopaco, y con una longitud mayor que el endoinjerto (2). El endoinjerto (2) dispone de una fenestración (5) en su pared pehmetral, y la guía de posicionamiento (3) está colocada en el interior del endoinjerto (2) sobresale por la boca posterior (17) del mismo, pasa por la fenestración (5) para discurrir por el exterior del endoinjerto de modo que el extremo libre de la guía (3) en el exterior del endoinjerto (2) tiene un orificio cerrado (4), tal y como se muestra en la Figura 1. In view of Figure 1, it can be seen how the fenestrated endoprosthesis (1) for the repair of arteries comprises an endograft (2) in the shape of a tubular body suitable for being placed inside an artery, and a positioning guide (3). ) of fenestration, which is wire-shaped, preferably radiopaque nitinol, and longer than the endograft (2). The endograft (2) has a fenestration (5) in its pehmetral wall, and the positioning guide (3) is placed inside the endograft (2) protrudes through the posterior mouth (17) of the same, passes through the fenestration (5) to run outside the endograft so that the free end of the guide (3) outside the endograft (2) has a closed hole (4), as shown in Figure 1.
La endoprótesis (1 ) dispone además de una vaina introductora (6) con forma tubular, y la cual tiene una pared pehmetral, un extremo posterior abierto y un extremo frontal (7) cerrado (preferentemente con forma cónica), y una fenestración (9) en la pared pehmetral en proximidad al extremo posterior abierto. The endoprosthesis (1) also has an introducer sheath (6) with a tubular shape, and which has a pehmetral wall, an open rear end and a closed front end (7) (preferably conical), and a fenestration (9 ) on the pehmetral wall in proximity to the open posterior end.
Dentro de la vaina introductora (6) está alojado el endoinjerto (2), y un tope (10) del sistema liberador alojado en la parte posterior de la vaina (6), el cual permite retroceder a la vaina (6) sin que el endoinjerto (2) se mueva. Inside the introducer sheath (6) the endograft (2) is housed, and a stop (10) of the release system housed in the back of the sheath (6), which allows the sheath (6) to go back without the graft. endograft (2) to move.
La guía de posicionamiento (3) está dispuesta de forma que discurre por el interior de la vaina (6) y por el interior del endoinjerto (2), discurre por una hendidura (8) del tope (10) y pasa por la fenestración (9) de la vaina (6) hacia el exterior de la misma. The positioning guide (3) is arranged so that it runs inside the sheath (6) and inside the endograft (2), runs through a slit (8) in the stop (10) and passes through the fenestration ( 9) of the sheath (6) towards the outside of the same.
En proximidad al extremo frontal (7) de la vaina (6), la guía (3) pasa por la fenestración (5) del endoinjerto (2) hacia el exterior para discurrir entre el endoinjertoClose to the front end (7) of the sheath (6), the guide (3) passes through the fenestration (5) of the endograft (2) towards the outside to run between the endograft
(2) y la vaina de posicionamiento, y pasa por una hendidura (18) en el extremo frontal (7) de la vaina (6) hacia el exterior. El extremo de la guía (3) con el orificio cerrado (4), queda posicionado en proximidad al extremo frontal (7) de la vaina (6). (2) and the positioning sleeve, and passes through a slit (18) in the front end (7) of the sleeve (6) to the outside. The end of the guide (3) with the closed hole (4) is positioned close to the front end (7) of the sheath (6).
Una guía rígida (15) se hace discurrir por el interior del endoinjerto (2), tal y como se realiza de forma habitual en las endopróteiss convencionales. A rigid guide (15) is passed through the interior of the endograft (2), as is usually done in conventional endoprostheses.
Tal y como se representa en la Figura 2A, el orificio cerrado (4) está obtenido doblando en forma de lazo parte del extremo de la propia guía de posicionamientoAs shown in Figure 2A, the closed hole (4) is obtained by bending part of the end of the positioning guide itself into a loop
(3). El orificio cerrado (4) está dimensionado para el paso a su través y de forma ajustada, de una segunda guía (11 ) con un diámetro de 0.0889 milímetros. Alternativamente, el orificio cerrado (4) se puede obtener anudando sobre sí misma la camisa exterior (12) de material plástico que recubre la guía (3), para formar el orificio cerrado, tal y como se ha representado en la Figura 2B. (3). The closed hole (4) is dimensioned for the passage through it and in a tight way, of a second guide (11) with a diameter of 0.0889 millimeters. Alternatively, the closed hole (4) can be obtained by knotting the outer plastic jacket (12) that covers the guide (3) over itself, to form the closed hole, as shown in Figure 2B.
Las Figuras 3 A - C ¡lustran parcialmente la técnica de canulación de una bifurcación arterial (13) a través de una endoprótesis fenestrada (1 ) in situ por el propio cirujano, para una sola fenestración. El procedimiento se realiza de manera coaxial por un único punto de acceso, y de forma resumida consta de las siguientes fases. Figures 3 A-C partially illustrate the cannulation technique of an arterial bifurcation (13) through a fenestrated endoprosthesis (1) in situ by the surgeon himself, for a single fenestration. The procedure is carried out coaxially through a single access point, and in summary it consists of the following phases.
Según se aprecia en la Figura 3 A, se progresa la guía (3) sobre una guía auxiliar (16) previamente canalizada en la arteria objetivo, mediante un catéter-balón (14) en la dirección de la flecha (F1 ) hasta alcanzar y quedar alojado en la arteria objetivo (Figura 3B). Entonces se introduce la endoprótesis fenestrada (1 ) apoyada o guiada sobre una guía rígida (15) tal y como muestra la Figura 3C, hasta una altura que coincida con la arteria objetivo, y posicionando correctamente la fenestración (5) del endoinjerto (2). As shown in Figure 3A, the guide (3) is advanced over an auxiliary guide (16) previously channeled into the target artery, by means of a balloon catheter (14) in the direction of the arrow (F1) until it reaches and remain lodged in the target artery (Figure 3B). The fenestrated endoprosthesis (1) is then introduced supported or guided on a rigid guide (15) as shown in Figure 3C, up to a height that coincides with the target artery, and correctly positioning the fenestration (5) of the endograft (2) .
Sobre la guía de posicionamiento (3) se ejerce una fuerza de tracción para permitir la progresión de la endoprótesis (1) que se trasmitirá hasta la punta de la guía (3), lo que provocaría la su expulsión de la arteria objetivo (según indica la flecha F2). El catéter-balón hinchado (14) hace tope con el anillo que forma el orificio cerrado (4) y ejerce esa misma fuerza en dirección contraria (según indica la flecha F3), con lo que se impide que se expulse la guía (3) de la arteria objetivo. A traction force is exerted on the positioning guide (3) to allow the progression of the endoprosthesis (1) that will be transmitted to the tip of the guide (3), which would cause its expulsion from the target artery (as indicated by the arrow F2). The swollen balloon-catheter (14) abuts the ring that forms the closed hole (4) and exerts the same force in the opposite direction (as indicated by arrow F3), thus preventing the guidewire (3) from being expelled. of the target artery.
Finalmente, se procedería a la liberación de la endoprótesis, y posterior retirada de las guías y colocación del stent de forma convencional. Finally, the endoprosthesis would be released, followed by removal of the guides and placement of the stent in a conventional manner.
El uso del dispositivo objeto de la invención, ha sido descrito de forma simplificada para una única fenestración, pero se podría extender a su realización en tantas ramas arteriales como fuera oportuno. Además, el dispositivo objeto de la invención, no solo se puede usar en arterias viscerales sino que podría aplicarse también a los TSA y en cualquier bifurcación arterial. The use of the device object of the invention has been described in a simplified way for a single fenestration, but it could be extended to its realization in as many arterial branches as appropriate. In addition, the device object of the invention can not only be used in visceral arteries but could also be applied to TSA and in any arterial bifurcation.

Claims

8 8
1.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, que comprende un endoinjerto con forma de cuerpo tubular adecuado para ser colocado dentro de una arteria, caracterizado porque además comprende una guía de posicionamiento de fenestración, donde la guía es insertadle a través de una fenestración del endoinjerto tubular, y donde la guía tiene forma de alambre con una longitud mayor que la del endoinjerto, y donde la guía dispone de un orificio cerrado en uno de sus extremos. 1.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, comprising a tubular body-shaped endograft suitable for being placed inside an artery, characterized in that it also comprises a fenestration positioning guide, where the guide is inserted through a fenestration of the tubular endograft, and where the guide is in the form of a wire with a length greater than that of the endograft, and where the guide has a closed hole at one of its ends.
2.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según la reivindicación 1 , caracterizada porque una parte de la guía de posicionamiento está alojada dentro del endoinjerto, y pasa a través de una fenestración del endoinjerto hacia el exterior del mismo, de forma que el extremo con el orificio cerrado está en el exterior del endoinjerto. 2. Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to claim 1, characterized in that a part of the positioning guide is housed within the endograft, and passes through a fenestration of the endograft towards the outside of it, so that the end with the hole closed is on the outside of the endograft.
3.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según las reivindicaciones 1 o 2, caracterizada porque el orificio cerrado está obtenido doblando en forma de lazo parte del extremo de la propia guía de posicionamiento. 3.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to claims 1 or 2, characterized in that the closed hole is obtained by bending part of the end of the positioning guide itself in the form of a loop.
4.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según las reivindicaciones 1 o 2, caracterizada porque la guía de posicionamiento dispone de una camisa exterior realizada de material plástico, y porque el orificio cerrado está realizado con parte de la camisa exterior plegada en forma de lazo. 4.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to claims 1 or 2, characterized in that the positioning guide has an outer jacket made of plastic material, and because the closed hole is made with part of the outer shirt folded in the form of a loop.
5.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según cualquiera de las reivindicaciones anteriores, caracterizada porque además comprende una vaina introductora con forma tubular, y porque el endoinjerto está alojado dentro de la vaina introductora, y donde la vaina dispone de una pared perimetral, un extremo posterior abierto y un extremo frontal 9 cerrado, donde la vaina dispone de un primera fenestración en la pared pehmetral en proximidad al extremo abierto, y donde la guía de posicionamiento está dispuesta de forma que discurre por el interior de la vaina de posicionamiento y por el interior del endoinjerto, pasa por la primera fenestración de la vaina hacia el exterior de la misma, pasa por la fenestración del endoinjerto para discurrir entre el mismo y la vaina de posicionamiento. 5.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to any of the preceding claims, characterized in that it also comprises an introducer sheath with a tubular shape, and in that the endograft is housed inside the introducer sheath, and where the sheath has a perimeter wall, an open rear end and a front end 9 closed, where the sheath has a first fenestration in the pehmetral wall in proximity to the open end, and where the positioning guide is arranged so that it runs inside the positioning sheath and inside the endograft, passing through the first fenestration of the sheath towards the outside of the same, passes through the fenestration of the endograft to run between it and the positioning sheath.
6.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según cualquiera de las reivindicaciones anteriores, caracterizada porque la guía de posicionamiento está realizada con un material metálico. 6.- Fenestrated endoprosthesis for the repair of arteries, provided with a fenestration positioning guide, according to any of the preceding claims, characterized in that the positioning guide is made of a metallic material.
7.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según la reivindicación 6, caracterizada porque el material metálico es un material con memoria de forma. 7.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to claim 6, characterized in that the metallic material is a material with shape memory.
8.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según la reivindicación 7, caracterizada porque está realizada con nitinol radiopaco. 8.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to claim 7, characterized in that it is made with radiopaque nitinol.
9.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según cualquiera de las reivindicaciones anteriores, caracterizada porque la guía de posicionamiento tiene un diámetro de 0.0889 milímetros. 9.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to any of the preceding claims, characterized in that the positioning guide has a diameter of 0.0889 millimeters.
10.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según cualquiera de las reivindicaciones anteriores, caracterizada porque el orificio cerrado está dimensionado para el paso a su través y de forma ajustada, de una segunda guía con un diámetro de 0.0889 milímetros. 10.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to any of the preceding claims, characterized in that the closed hole is dimensioned for the passage through it and in a tight way, of a second guide with a diameter of 0.0889 millimeters.
11.- Endoprótesis fenestrada para la reparación de arterias, dotada de guía de posicionamiento de fenestración, según la reivindicación 5 caracterizada porque el extremo frontal cerrado de la vaina introductora tiene forma cónica. 11.- Fenestrated endoprosthesis for the repair of arteries, equipped with a fenestration positioning guide, according to claim 5, characterized in that the closed front end of the introducer sheath has a conical shape.
PCT/ES2021/070876 2020-12-10 2021-12-09 Fenestrated stent for artery repair, provided with a fenestration positioning guide WO2022123099A1 (en)

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ES202032664U ES1261204Y (en) 2020-12-10 2020-12-10 FENESTRATED ENDOPROTHESIS FOR ARTERY REPAIR, EQUIPPED WITH A FENESTRATION POSITIONING GUIDE
ESU202032664 2020-12-10

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999029262A1 (en) * 1997-12-10 1999-06-17 William A. Cook Australia Pty. Ltd. Endoluminal aortic stents
US20040243221A1 (en) * 2003-05-27 2004-12-02 Fawzi Natalie V. Endovascular graft including substructure for positioning and sealing within vasculature
US20140277347A1 (en) * 2013-03-15 2014-09-18 W. L. Gore & Associates, Inc. Endoprosthetic device comprising a support channel capapble of receiving a branch endoprosthetic device
EP3078349A1 (en) * 2015-04-10 2016-10-12 Cook Medical Technologies LLC Prosthesis with fenestration

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999029262A1 (en) * 1997-12-10 1999-06-17 William A. Cook Australia Pty. Ltd. Endoluminal aortic stents
US20040243221A1 (en) * 2003-05-27 2004-12-02 Fawzi Natalie V. Endovascular graft including substructure for positioning and sealing within vasculature
US20140277347A1 (en) * 2013-03-15 2014-09-18 W. L. Gore & Associates, Inc. Endoprosthetic device comprising a support channel capapble of receiving a branch endoprosthetic device
EP3078349A1 (en) * 2015-04-10 2016-10-12 Cook Medical Technologies LLC Prosthesis with fenestration

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