W. L. Gore & Associates, Inc.

Gore Enterprise Holdings, Inc.

Zahid Amin

Edward H Cully

Edward Emil Shaw

Steven J Masters

Coby C Larsen

Warren Cutright

Warren Cutwright

Coby Larsen

This disclosure is directed to an aperture occlusion device and a method for occluding an aperture, including a perimembranous ventricular septal defect. The aperture occlusion device includes a wire frame element. The wire frame forms geometric shapes that include an occluder region and a securing region. The occluder region and the securing region are separated by an attachment region including a waist. The occluder region and securing region can include membranous coverings. The device can be attached to a delivery hub. The wires forming the occluder region and securing region can have a shape-memory capability such that they can be collapsed and distorted in a sheath during delivery, but resume and maintain their intended shape after delivery.

Heart occlusion devices

Devices for occluding an aperture in tissue or a vessel include a first flexible wire and a second flexible wire. Each of the first and second wires is formed of a shape memory material. Each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane. The first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire. Methods for occluding an aperture in tissue or a vessel using such devices are also provided.

The disclosure is directed to a heart occlusion device and a method for occluding an aperture defect in a heart. The heart occlusion device includes two separate wires. Each wire forms geometric shapes that together form a distal plate and a proximal plate. The first plate is disposed in a first plane. The second plate is disposed in a second plane that is parallel to and remote from the first plane. The distal plate and the proximal plate are separated by a self-centering waist. The proximal plate is attached to a hub. A similar hub is optional on the distal plate. The plates further include coverings which form a sealant to occlude an aperture in a tissue. The wires forming the plates have a shape-memory capability such that they can be collapsed and distorted in a catheter during delivery but resume and maintain their intended shape after delivery.

The present invention is specifically directed to a heart occlusion device with a self-centering mechanism. The heart occlusion device includes two separate uniquely shaped wires, each forming shapes that mirror the respective wire's shapes. Each wire forms half-discs or quarter-discs that together form a distal disc and a proximal disc. In other versions, the device includes four separate wires, each mirroring its neighboring wire and forming a proximal and a distal quarter-disc. In the versions with four wires, the quarter-discs of each wire together form proximal and distal discs. The distal disc and proximal disc are separated by a self-centering waist. The proximal disc is attached to a hub comprising a screw mechanism. A similar hub is optional on the distal disc. The discs further include coverings which form a sealant to occlude an aperture in a tissue. The wires forming the discs have a shape-memory capability such that they can be collapsed and distorted in a catheter during delivery but resume and maintain their intended shape after delivery.

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Omaha, NE, United States of America

Zahid Amin