Aneurysm Occlusion Device with Sequence of Shape-Changing Embolic Members
US-2016206321-A1 · Jul 21, 2016 · US
US11679458B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-11679458-B2 |
| Application number | US-202016949570-A |
| Country | US |
| Kind code | B2 |
| Filing date | Nov 3, 2020 |
| Priority date | Nov 4, 2019 |
| Publication date | Jun 20, 2023 |
| Grant date | Jun 20, 2023 |
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Occlusive devices and associated methods of manufacturing are disclosed herein. Manufacturing an occlusive device can include conforming a mesh to a forming assembly and setting a shape of the mesh based on the forming assembly. In some embodiments, the forming assembly comprises multiple forming members, a mandrel, and/or one or more coupling elements. The method may include everting the mesh over the forming assembly such that the mesh encloses an open volume with a shape based, at least in part, on the shape of the forming assembly. According to some embodiments, setting a shape of the mesh comprises heat-treating the mesh and forming assembly.
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We claim: 1. A method for making an occlusive device, the method comprising: obtaining a tubular mesh having a lumen therethrough; obtaining a forming member having an outer surface and an inner surface; everting the mesh over the forming member such that a first portion of the mesh conforms to the outer surface of the forming member and a second portion of the mesh conforms to the inner surface of the forming member; setting a shape of the mesh while positioned over the forming member. 2. The method of claim 1 , wherein the forming member is a first forming member, the inner surface is a first mating surface, and the method further comprises positioning the second portion of the mesh between the first mating surface of the first forming member and a second mating surface of a second forming member such that the second portion of the mesh conforms to the first and second mating surfaces of the first and second forming members, respectively. 3. The method of claim 2 , further comprising compressing the second portion of the mesh between the first and second mating surfaces. 4. The method of claim 1 , further comprising positioning an elongate member within the lumen of the mesh and conforming a third portion of the mesh to the elongate member. 5. The method of claim 1 , wherein setting the shape of the mesh comprises heat-treating the mesh while positioned on the forming member. 6. The method of claim 1 , wherein, when positioned over the forming member, the first portion of the mesh is spaced apart from the second portion of the mesh by a thickness of the forming member between the inner and outer surfaces. 7. The method of claim 1 , wherein, after setting the shape of the mesh, the first and second portions of the mesh form a dual-layer sidewall that encloses an open volume. 8. The method of claim 1 , wherein the forming member includes a lumen extending therethrough. 9. The method of claim 1 , wherein the inner surface of the forming member is arcuate and defines a cavity in the forming member. 10. A method for making an occlusive device, the method comprising: obtaining a tubular mesh having a lumen extending therethrough and a porosity configured to substantially prevent blood flow through the mesh, the mesh comprising first and second end portions and an intermediate portion therebetween; obtaining a forming assembly comprising: a first member having a generally globular shape and a lumen extending therethrough, wherein the first member has a first mating surface comprising at least a portion of an outer surface of the first member; and a second member having a generally hemispherical shape and a cavity with an arcuate surface, the second member having a lumen extending therethrough; positioning at least a first portion of the intermediate portion of the mesh over an outer surface of the second member; positioning at least a portion of the first end portion of the mesh within the lumen of the first member; positioning at least a second portion of the intermediate portion of the mesh between the first mating surface of the first member and the arcuate surface of the second member such that the second portion substantially conforms to the first mating surface and the arcuate surface; setting a shape of the mesh while the mesh is positioned on the forming assembly. 11. The method of claim 10 , wherein positioning the second portion of the intermediate portion of the mesh between the first mating surface of the first member and the arcuate surface of the second member comprises positioning the first member at least partially within the cavity of the second member. 12. The method of claim 10 , wherein, after setting the shape of the mesh, the mesh comprises a contoured configuration in which the first and second end portions of the mesh have a substantially tubular shape and the intermediate portion of the mesh is substantially bowl-shaped. 13. The method of claim 10 , further comprising positioning an elongate member within the lumen of the tubular mesh, the lumen of the second member, and the lumen of the second member and conforming the first and second end portions of the mesh to an outer surface of the elongate member. 14. The method of claim 10 , further comprising coupling a first coupling element to the second end portion of the mesh at a location adjacent an outer surface of the second member and coupling a second coupling element to the first end portion of the mesh at a location adjacent the arcuate surface of the second member. 15. A method for making an occlusive device, the method comprising: obtaining a tubular mesh having a lumen extending therethrough and a porosity configured to substantially prevent blood flow through the mesh, the mesh comprising first and second end portions and an intermediate portion therebetween; obtaining a forming member having a first surface, a second surface opposite the first surface along a thickness of the forming member, a sidewall therebetween, and a lumen extending through the first and second surfaces of the forming member; positioning at least a first portion of the intermediate portion of the mesh within the lumen of the forming member such that the first end portion of the mesh extends away from the first surface of the forming member in a first direction and the second end portion of the mesh extends away from the second surface of the forming member in a second direction opposite the first direction; everting the mesh over the forming member such that the first and second end portions of the mesh extend away from the second surface of the forming member in the second direction, wherein everting the mesh causes the first end portion of the mesh to substantially conform to the first and second surfaces and the sidewall of the forming member; and setting a shape of the mesh while positioned on the forming member. 16. The method of claim 15 , further comprising positioning an elongate member within the lumen of the tubular mesh and the lumen of the forming member and further comprising conforming the first and second end portions of the mesh to an outer surface of the elongate member. 17. The method of claim 15 , wherein the sidewall is annular such that the forming member comprises a generally cylindrical shape. 18. The method of claim 15 , wherein, after setting a shape of the mesh, the mesh comprises a contoured configuration comprising a substantially tubular open end portion, a substantially tubular intermediate portion, and a substantially disc shaped closed end portion disposed at an angle to the open end and intermediate portions. 19. The method of claim 15 , wherein the forming member is a first forming member and, after setting the shape of the mesh, the mesh is a contoured mesh, the method further comprising: separating the contoured mesh from the first forming member; obtaining a forming assembly comprising a second forming member and a third forming member, wherein: the second forming member comprises a body portion having a first surface, a second surface opposite the first surface along a thickness of the second forming member, a sidewall therebetween, a protrusion extending from the first surface in a first direction, and a lumen extending through the body portion and the protrusion; and the third forming member comprises a body portion having a first surface, a second surface opposite the first surface along a thickness of the third forming member, a sidewall therebetween, and a lumen extending through the body portion; positioning the intermediate
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