Implantable frame with variable compliance
First Claim
Patent Images
1. A medical device for implantation in a body vessel, the medical device comprising:
- a tubular, implantable frame defining a lumen about a longitudinal axis and having a first frame member including a plurality of struts and bends interconnecting the struts, the first frame member comprising a non-bioabsorbable material, and a second frame member including a plurality of struts and bends interconnecting the struts, the second frame member configured to increase in compliance after implantation of said medical device, the second frame member attached to the first frame member at least at two attachment points and disposed radially outward such that the second frame is to contact said body vessel, the implantable frame being radially movable between an expanded configuration and a compressed configuration, the implantable frame having a first compliance in a first radial direction at implantation and a second compliance in the first radial direction after passage of a predetermined period of time after implantation; and
a valve leaflet comprising a remodelable material, the valve leaflet being attached to the frame between the two attachment points, wherein at the two attachment points a portion of the valve leaflet is interposed between the first and second frame members to protect the valve leaflet from contacting the body vessel, wherein the implantable frame having the first compliance maintains a mechanical load on the valve leaflet to promote remodeling for the predetermined period of time.
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Abstract
Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. Embodiments of the invention relate to medical devices comprising a frame having a compliance that can change upon implantation of the medical device within the lumen of a body vessel. Controlled fracture or bioabsorption of frame material can, in some embodiments, increase the compliance of a frame after implantation. Medical devices comprising a frame and one or more valve members adapted to regulate fluid flow in a body vessel, such as a vein, are also provided.
132 Citations
20 Claims
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1. A medical device for implantation in a body vessel, the medical device comprising:
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a tubular, implantable frame defining a lumen about a longitudinal axis and having a first frame member including a plurality of struts and bends interconnecting the struts, the first frame member comprising a non-bioabsorbable material, and a second frame member including a plurality of struts and bends interconnecting the struts, the second frame member configured to increase in compliance after implantation of said medical device, the second frame member attached to the first frame member at least at two attachment points and disposed radially outward such that the second frame is to contact said body vessel, the implantable frame being radially movable between an expanded configuration and a compressed configuration, the implantable frame having a first compliance in a first radial direction at implantation and a second compliance in the first radial direction after passage of a predetermined period of time after implantation; and a valve leaflet comprising a remodelable material, the valve leaflet being attached to the frame between the two attachment points, wherein at the two attachment points a portion of the valve leaflet is interposed between the first and second frame members to protect the valve leaflet from contacting the body vessel, wherein the implantable frame having the first compliance maintains a mechanical load on the valve leaflet to promote remodeling for the predetermined period of time. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A medical device for implantation in a body vessel, the medical device comprising:
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a tubular, implantable frame defining a lumen about a longitudinal axis and having a first frame member including a plurality of struts and bends interconnecting the struts, the first frame member comprising a non-bioabsorbable material, and a second frame member including a plurality of struts and bends interconnecting the struts, the second frame member comprising a bioabsorbable material configured to degrade during passage of a predetermined period of time after implantation, the second frame member attached to the first frame member at least at two attachment points and disposed radially outward such that the second frame is to contact said body vessel, the implantable frame being radially movable between an expanded configuration and a compressed configuration, the implantable frame having a first compliance in a first radial direction at implantation and a second compliance less than the first compliance in the first radial direction after passage of the predetermined period of time; and a valve leaflet comprising a remodelable material, the valve leaflet being attached along the struts of the first frame member between the two attachment points and disposed across the frame lumen, wherein at the two attachment points a portion of the valve leaflet is interposed between the first and second frame members to protect the valve leaflet from contacting the body vessel, wherein the implantable frame having the first compliance maintains a mechanical load on the valve leaflet to promote remodeling during the predetermined period of time.
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20. A medical device for implantation in a body vessel, the medical device comprising:
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a tubular, implantable frame defining a lumen about a longitudinal axis and having a first frame member including a plurality of struts and bends interconnecting the struts, the first frame member comprising a non-bioabsorbable material, and a second frame member including a plurality of struts and bends interconnecting the struts, the second frame member comprising a bioabsorbable material configured to degrade during passage of a predetermined time after implantation, the second frame member attached to the first frame member at least at two attachment points and disposed radially outward such that the second frame is to contact said body vessel, the implantable frame being radially movable between an expanded configuration and a compressed configuration, the implantable frame having a first compliance in a first radial direction at implantation and a second compliance less than the first compliance in the first radial direction after passage of the predetermined period; and a first valve leaflet and a second valve leaflet each comprising a remodelable material, the first and second valve leaflets being attached along the struts of the first frame member between two attachment points and disposed across the frame lumen, the first and second valve leaflets being disposed opposite each other to form a coaptation region where the leaflets cooperate to regulate fluid flow through the frame lumen, wherein at the two attachment points a portion of the first and second valve leaflets is interposed between the first and second frame members to protect the valve leaflets from contacting the body vessel, wherein the implantable frame having the first compliance maintains a mechanical load on the valve leaflets to promote remodeling during the predetermined period of time.
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Specification