Covering for an endoprosthetic device and methods of using for aneurysm treatment
Inventors
Assignees
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Publication Number
US-9060851-B2
Publication Date
2015-06-23
Expiration Date
Abstract
The present invention relates to covered endoprosthetic devices. Covered endoprosthetic devices comprise an endoprosthesis and a sheath. The sheath comprises a central portion and outer portions, wherein the central portion preferentially restricts or causes a restriction of blood flow. Blood flow can be reduced by the central portion of the sheath by varying the permeability of the sheath or by having projections on the sheath that slow blood flow. Permeability may be provided by perforations or holes in the material of the sheath or by varying the polymer structure that makes up the sheath itself. The outer portions of the sheath do not substantially reduce blood flow. Methods of using sheath-covered endoprosthetic devices of the invention to treat aneurysms, especially aneurysms in proximity to small perforator vessels or arteries, are also encompassed.
Core Innovation
The described invention relates to treating an aneurysm in a lumen of a vessel using a sheath-covered endoprosthetic device. The sheath has a porosity in the range of 10-100 micrometers and is substantially uniformly permeable over the entirety of its length. The porosity is provided by a plurality of perforations of variable size and shape, allowing blood flow into areas that have an outflow while restricting blood flow into areas that do not have an out-flow.
In the covered endoprosthetic device, a positioning relationship is established so that any portion of the sheath faces the aneurysm, including positioning such that a portion or a center of the sheath is located on the aneurysm. The arrangement preferentially restricts blood flow to the aneurysm while substantially preserving flow to surrounding regions, including small perforator vessels near the aneurysm neck, as those surrounding regions are characterized as regions that have outflow.
The invention further includes device and sheath structural concepts in which the sheath is coupled with an endoprosthesis, preferably an endoprosthetic stent, with the sheath located on an external surface of the endoprosthetic device. Perforations extend through the sheath from an endoprosthetic device-facing surface to an outer surface, and the sheath can be formed from a plurality of strands of polymer material. Additional embodiments include optional concepts such as a localized biodegradable coating on the central portion of the sheath with one or more agents that promote inflammation or thrombogenicity.
Claims Coverage
The provided partial content identifies two independent claims, one method claim and one device claim, each centered on using a sheath with 10-100 micrometer porosity configured to be substantially uniformly permeable via perforations of variable size and shape to selectively restrict versus allow blood flow based on outflow presence. The inventive features are further refined in dependent claims by specifying placement relative to the aneurysm and adjacent perforator vessels, and by specifying sheath construction details such as polymer strand formation and through-sheath perforations, with optional localized biologically active coating on a central portion.
Sheath porosity enabling selective blood-flow based on outflow regions
A sheath with a porosity in the range of 10-100 micrometers that is substantially uniformly permeable over the entirety of its length, wherein said porosity is provided by a plurality of perforations of variable size and shape, and wherein the resulting sheath permeability allows blood flow into areas that have an outflow but restricts blood flow into areas that do not have an out-flow.
Positioning sheath-covered endoprosthetic device to face the aneurysm
Positioning said sheath-covered endoprosthetic device in said lumen such that any portion of said sheath is facing said aneurysm.
Sheath perforations provided by variable size and shape across a substantially uniformly permeable sheath
Providing said porosity by a plurality of perforations of variable size and shape, wherein said sheath is substantially uniformly permeable over the entirety of said length.
Sheath located on an external surface of the endoprosthetic device
A device for treating an aneurysm comprising an endoprosthetic device and a sheath, wherein said sheath is located on an external surface of said endoprosthetic device.
Sheath permeability restricting blood flow while preserving outflow regions
The resulting sheath permeability allows blood flow into areas that have an outflow but restricts blood flow into areas that do not have an out-flow.
Across the independent claims, the core claim coverage is directed to an aneurysm treatment in which an endoprosthetic device is associated with a substantially uniformly permeable sheath having 10-100 micrometer porosity formed by perforations of variable size and shape. The sheath permeability is configured to permit blood flow into regions characterized as having outflow while restricting blood flow into regions characterized as not having out-flow, with further claim refinements relating to sheath positioning relative to the aneurysm and detailed sheath/perforation construction, and optional localized biologically active coating on the central portion.
Stated Advantages
Allows blood flow into areas that have an outflow while restricting blood flow into areas that do not have an out-flow.
Preferentially restricts blood flow to the aneurysm while substantially preserving flow to surrounding regions, including small perforator vessels near the aneurysm neck.
Documented Applications
Treating an aneurysm in a lumen of a vessel by placing a sheath-covered endoprosthetic device in the area of the aneurysm and positioning the sheath to face the aneurysm.
Providing a device for treating an aneurysm comprising an endoprosthetic device and a sheath arranged to selectively restrict blood flow based on outflow regions.
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