ES2542312T3 - Método para aumentar la resistencia a la fractura de un dispositivo médico liberador de fármacos - Google Patents

Método para aumentar la resistencia a la fractura de un dispositivo médico liberador de fármacos Download PDF

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ES2542312T3
ES2542312T3 ES10727625.5T ES10727625T ES2542312T3 ES 2542312 T3 ES2542312 T3 ES 2542312T3 ES 10727625 T ES10727625 T ES 10727625T ES 2542312 T3 ES2542312 T3 ES 2542312T3
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diameter
polymer
scaffolding
stent
drug
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Yunbing Wang
Daniel A. Castro
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Abbott Cardiovascular Systems Inc
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Abbott Cardiovascular Systems Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91566—Adjacent bands being connected to each other connected trough to trough
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00—Processes for applying liquids or other fluent materials
    • B05D1/34—Applying different liquids or other fluent materials simultaneously
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49908—Joining by deforming
    • Y10T29/49909—Securing cup or tube between axially extending concentric annuli
    • Y10T29/49913—Securing cup or tube between axially extending concentric annuli by constricting outer annulus

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Método para aumentar la resistencia a la fractura de un stent de polímeros liberador de fármacos que presenta un diámetro desplegado y un diámetro plegado, caracterizado por los pasos de: expansión radial de un tubo de polímeros extrudido hasta un diámetro inicial que es mayor que el diámetro desplegado del stent; formación de un andamiaje (700) de stent a partir del tubo; reducción del diámetro del andamiaje hasta alrededor de un 50-80 % del diámetro inicial; pulverización de una solución que comprende un fármaco-polímero disuelto en un disolvente sobre la superficie del andamiaje, en el que la solución pulverizada se encuentra entre un 90-98 % en peso de disolvente; cocción del andamiaje que presenta en este el fármaco-polímero durante un primer periodo de relajación; y engaste del stent hasta su diámetro plegado que incluye una pluralidad de pasos intermedios de engaste, en el que al menos un paso intermedio de engaste es seguido de un segundo periodo de relajación.

Description

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E10727625
13-07-2015
diámetro desplegado puede ser de hasta 4,0, o el diámetro desplegado es entre un 250-400 % mayor que el diámetro engastado para un andamiaje de polímeros de balón expandido.
[0042] Según un aspecto de la invención, un método para aumentar la resistencia a la fractura se aplica a un andamiaje que presenta un par de struts que forman una parte de una celda cerrada espaciada en un ángulo
5 mayor de 100 grados o entre 124 y 132 grados desde un strut opuesto. Un ejemplo de dicho patrón de andamiaje está representado en la FIG. 3. El patrón de celdas cerradas presenta elementos en forma de W formados por unos struts interconectados 730. En referencia a las FIGS. 3-4, un punto de articulación constituye los elementos de anillo 732 de un anillo 712. Se forma el ángulo F cuando se comprime el andamiaje, y un ángulo D (mayor que F) cuando se despliega.
10 [0043] Después de formarse el andamiaje, se lleva a cabo un paso de reducción del diámetro en dos etapas. Según una forma de realización preferida, un andamiaje de PLLA se somete a una temperatura de 48 grados centígrados durante 35 segundos, después un aparato de engaste reduce su diámetro alrededor de un 60 %, por ejemplo, de un diámetro de 3,45 a un diámetro de 2,03. La temperatura se mantiene 48 grados centígrados
15 durante el engaste. Tras el engaste, se espera algo de retroceso elástico. Se espera que, en general, la reducción inicial del diámetro pueda determinarse, dentro de una aproximación razonable, a partir del tipo de patrón de andamiaje existente. Para el patrón de andamiaje representado en la FIG. 3, se observó que una reducción de un 60 % funcionaba bien.
20 [0044] Se cree que una reducción inicial del diámetro de entre alrededor de 55 a 65 % a partir de un diámetro inicial puede producir diferencias perceptibles en la cantidad de agrietamiento/desconchado del revestimiento de un andamiaje de polímeros que presenta un patrón de celdas cerradas, como por ejemplo el de la FIG. 3. No obstante, como se ha explicado anteriormente, este paso de reducción del diámetro, por sí solo, puede no producir resultados aceptables. Los resultados pueden variar en función de la naturaleza del patrón de andamiaje,
25 la composición del revestimiento, el método de aplicación del revestimiento y el método de engaste, como se ha tratado anteriormente.
[0045] Como se podrá apreciar en vista de la presente exposición, con el objetivo de prevenir o corregir un problema de agrietamiento/desconchado con mayor consistencia, el alcance de la investigación no puede 30 restringirse a un paso de reducción del diámetro antes del revestimiento. Lamentablemente, los inventores observaron que las complejidades asociadas a un problema de fractura de un revestimiento de polímero-fármaco sobre un andamiaje de polímeros no se prestan a una solución tan sencilla. Según este aspecto de la invención, un método para aumentar la resistencia a la fractura, por tanto, incluye no solo un paso de reducción del diámetro de alrededor de un 50-80 %, sino también una reducción del diámetro de un andamiaje de polímeros, 35 por ejemplo, uno que presente un patrón de celdas cerradas y un desplazamiento de struts entre los diámetros engastado y desplegado, tal y como se ha explicado anteriormente en relación con las FIGS. 2-4; un proceso de revestimiento que incluye el depósito de un fármaco-polímero mezclado con un disolvente en una cantidad de entre alrededor de 90-98 % en peso de disolvente; un paso de recocido de alrededor de 15-60 min a una temperatura de relajación de alrededor de 5-20 grados por debajo de una temperatura de transición vítrea de un
40 polímero amorfo y semicristalino, y un proceso de engaste que incluye una reducción del diámetro en tres partes a una temperatura de relajación de entre 5-20 grados por debajo de una temperatura de transición vítrea de un polímero amorfo (revestimiento) y un polímero semicristalino (andamiaje).
[0046] Se pretende que «temperatura de relajación» exprese una temperatura, relativamente próxima a la
45 temperatura de transición vítrea del polímero, por ejemplo, a entre 10 y 20 grados de la temperatura de transición vítrea, que atenúe las tensiones internas/tirantez inducidas por una deformación o manipulación del material cuando el material se somete a esta temperatura elevada durante un periodo suficiente de tiempo. Cuanto más próxima esté a la temperatura de transición vítrea y por encima de esta, con mayor rapidez tiene lugar este proceso de relajación. Si el polímero está sometido a la temperatura de relajación durante mucho tiempo,
50 entonces la orientación de la estructura empieza a romperse, lo que debilita el material. Se pretende que «periodo de relajación» exprese el periodo de tiempo durante el cual el polímero está sometido a una temperatura de relajación y que tiene el efecto de atenuar las tensiones internas del material.
[0047] Ahora que el cuerpo de stent se encuentra a alrededor de un 60 % de su diámetro máximo, se aplica el
55 peso de revestimiento deseado mediante un proceso de revestimiento por pulverización. Se describen ejemplos de un proceso de revestimiento por pulverización en las publicaciones de los Estados Unidos n. os 2009/0087541 y 2007/0281073.
[0048] Después de que el ciclo de pulverización-secado esté completo, el stent se coloca preferentemente en un
60 horno para retirar cualquier disolvente restante. Según un aspecto de la invención, este paso de cocción, que originalmente se concibió con el objetivo de evaporar el disolvente tras los pasos de pulverización-secado, puede que también aumente la resistencia a la fractura del stent de polímeros liberador de fármacos. La exposición prolongada a la temperatura de relajación durante la cocción y tras el proceso de pulverización-secado atenúa las tensiones internas en la capa de polímero-fármaco, el andamiaje y la capa de transición, intermedia o de
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Claims (1)

  1. imagen1
ES10727625.5T 2009-06-23 2010-06-18 Método para aumentar la resistencia a la fractura de un dispositivo médico liberador de fármacos Active ES2542312T3 (es)

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US490248 2009-06-23
US12/490,248 US8597716B2 (en) 2009-06-23 2009-06-23 Methods to increase fracture resistance of a drug-eluting medical device
PCT/US2010/039226 WO2010151497A1 (en) 2009-06-23 2010-06-18 Methods to increase fracture resistance of a drug-eluting medical device

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ES2542312T3 true ES2542312T3 (es) 2015-08-04

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