Occlusion devices and methods of their manufacture and use
AssigneeW. L. Gore & Associates, Inc.
InventorJeffrey B. Duncan
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Abstract
Disclosed are implantable medical devices for the occlusion of a bodily lumen, cavity, vessel, or organ, as well as methods for manufacturing such occlusion devices, and methods for treating a subject using the occlusion devices. The devices generally include a wire having shape memory properties and a flexible membranous material disposed about the wire. Some embodiments include a lateral fringe on the membranous material. Some embodiments include a fluid capture cup affixed to the wire.
Claims26
A method of making an implantable occlusion device, comprising:
- providing at least one shape memory wire;
- forming the shape memory wire into a coil, the coil having an overall outside diameter and a coil length;
- providing a flexible polymeric tube, the flexible polymeric tube having an inside diameter that is smaller than the overall outside diameter of the coil;
- elongating the coil, wherein the elongated coil has an elongated coil length that is greater than the coil length, and wherein the elongated coil has an elongated coil diameter that is less than the overall outside diameter of the coil;
- fitting the flexible polymeric tube over the elongated coil;
- and
- allowing the elongated coil to recoil to a contracted length, wherein the contracted length is less than the elongated coil length, thereby causing the flexible polymeric tube to form an irregular shape useful for occlusion.
A method of making an implantable occlusion device, comprising:
- providing at least one shape memory wire;
- forming the shape memory wire into a coil, the coil having an overall outside diameter;
- elongating the coil, thereby increasing a length of the coil to an elongated length and reducing the overall outside diameter of the coil;
- wrapping a flexible polymeric material onto the elongated coil, wherein the elongated coil is substantially covered by the flexible polymeric material, and wherein portions of the flexible polymeric material are not in direct contact with the elongated coil;
- and
- allowing the elongated coil to recoil to a contracted length, wherein the contracted length is less than the elongated length, thereby causing the flexible polymeric material to form an irregular shape useful for occlusion.
A device for limiting fluid flow through a lumen in a bodily tissue, comprising:
- at least one wire with proximal and distal ends;
- and
- a flexible polymeric cup, wherein the flexible polymeric cup includes an open end affixed to the proximal end of the wire, wherein the flexible polymeric cup is adapted to be reconfigured during deployment into the lumen from a pre-deployed state to an everted state, and wherein the flexible polymeric cup in the everted state is adapted to limit fluid flow through the lumen.
A method for occluding a lumen in a bodily tissue, comprising:
- providing an occlusion device, wherein the occlusion device comprises:
- at least one wire with proximal and distal ends;
- and
- a flexible polymeric cup, wherein the flexible polymeric cup includes an open end affixed to the proximal end of the wire, wherein the flexible polymeric cup is adapted to be reconfigured during deployment into the lumen from a pre-deployed state to an everted state, and wherein the flexible polymeric cup in the everted state is adapted to occlude the lumen;
- providing a delivery sheath, wherein the delivery sheath comprises a delivery lumen;
- configuring, within the delivery lumen, the occlusion device in the pre-deployed state;
- delivering the delivery lumen including the occlusion device in the pre-deployed state to a target site within the lumen;
- and
- deploying the occlusion device at the target site within the lumen, wherein the deploying comprises:
- ejecting the occlusion device from the delivery lumen;
- and
- reconfiguring the flexible polymeric cup from the pre-deployed state to the everted state.
A method of making an implantable occlusion device, comprising:
- providing at least one shape memory wire;
- forming the shape memory wire into a cup frame, the cup frame having an overall outside diameter and open proximal and distal ends;
- and
- affixing a flexible polymeric cup to the proximal end of the cup frame, wherein the flexible polymeric cup includes an open end and a closed end, wherein the open end is affixed to the cup frame, wherein the flexible polymeric cup is adapted to be reconfigured during implantation in a bodily lumen from a pre-deployed state to an everted state, and wherein the flexible polymeric cup in the everted state is adapted to occlude the lumen.
Dependencies are inferred from the claim text.