Collapsible medical device for atrial sealing and trans-septal access
The present disclosure provides collapsible medical devices that may be introduced via a delivery device into a pre-existing patent foramen ovale or trans-septal puncture hole and left in place to provide both a sealing function on the atrial wall and a septal-access function for additional procedures. The disclosed medical devices include a penetrable and re-sealable gasket material disposed in an open lumen in the medical device. This penetrable and re-sealable material allows catheters or other medical devices to pass therethough for providing additional therapy to an individual. By allowing the access point or portal to be opened by a guidewire or another medical tool, the medical devices as disclosed herein may be particularly suitable for a variety of cardiac procedures including, for example, atrial fibrillation, mitral valve replacement or repair, left atrial appendage closures, and the like.
1. A collapsible medical device for occluding a trans-septal hole comprising:
a tubular member formed of a braided fabric having a preset, expanded configuration and a collapsed configuration and comprising a proximal end and a distal end, wherein, in the expanded configuration, the tubular member comprises a proximal disc-shaped portion adjacent to the proximal end, a distal disc-shaped portion adjacent to the distal end, and a cylindrical segment between the proximal disc-shaped portion and the distal disc-shaped portion, wherein proximal free wire ends of the braided fabric extend longitudinally proximally from the proximal disc-shaped portion to the proximal end of the tubular member and distal free wire ends of the braided fabric extend longitudinally distally from the distal disc-shaped portion to the distal end of the tubular member, the proximal and distal free wire ends and cylindrical segment collectively defining an open lumen through the tubular member; and
a gasket disposed at least partially within the cylindrical segment, wherein the gasket extends into and occupies at least a portion of the open lumen defined by the proximal or distal free wire ends, the gasket sized and configured to be penetrable and re-scalable.
2. The collapsible medical device of claim 1 , wherein the tubular member is formed from a single layer of braided fabric.
3. The collapsible medical device of claim 1 , wherein the open lumen is concentric with the proximal and distal disc-shaped portions.
4. The collapsible medical device of claim 1 , further comprising:
a securement mechanism on at least one of the proximal or the distal end of the tubular member for immobilizing the respective at least one of the proximal or distal free wire ends.
5. The collapsible medical device of claim 4 , wherein the securement mechanism comprises a coating.
6. The collapsible medical device of claim 1 , wherein the gasket is secured to the cylindrical segment using one or more sutures.
7. The collapsible medical device of claim 1 , wherein the gasket is comprised of a substantially self-sealing material.
8. The collapsible medical device of claim 1 , wherein the gasket includes one or more pre-cut slits therein to facilitate penetration therethrough by another medical device.
9. The collapsible medical device of claim 1 , wherein the gasket includes an antithrombogenic coating thereon.
10. The collapsible medical device of claim 1 , wherein the gasket has a uniform density.
11. The collapsible medical device of claim 1 , wherein the gasket has a non-uniform density.
12. The collapsible medical device of claim 1 , wherein the proximal disc-shaped portion and the distal disc-shaped portion are substantially the same size, or wherein the proximal disc-shaped portion and the distal disc-shaped portion are different sizes.
13. The collapsible medical device of claim 1 , wherein the cylindrical segment extends from the proximal disc-shaped portion to the distal disc-shaped portion, and wherein the gasket occupies an entire length of the cylindrical segment.
14. The collapsible medical device of claim 1 , further comprising an additional component coupled to the proximal free wire ends within the open lumen, wherein the additional component is sized and configured to interface with a delivery device to deliver the collapsible medical device to the trans-septal hole.
15. A collapsible medical device for occluding a trans-septal hole comprising:
a tubular member formed of a braided fabric having a preset, expanded configuration and a collapsed configuration and comprising a proximal end and a distal end, wherein, in the expanded configuration the tubular member comprises at least one first plane of occlusion adjacent to the proximal end, at least one second plane of occlusion adjacent to the distal end, and a segment therebetween, wherein proximal free wire ends of the braided fabric extend longitudinally proximally from the at least one first plane of occlusion to the proximal end of the tubular member and distal free wire ends of the braided fabric extend longitudinally distally from the at least one second plane of occlusion to the distal end of the tubular member, the proximal and distal free wire ends and the segment collectively defining an open lumen through the tubular member; and
a gasket disposed at least partially within the segment, wherein the gasket extends into and occupies at least a portion of the open lumen defined by the proximal or distal free wire ends, the gasket sized and configured to be penetrable and re-sealable.
16. The collapsible medical device of claim 15 , wherein the gasket is secured to the segment using one or more sutures.
17. The collapsible medical device of claim 15 , wherein the gasket is comprised of a substantially self-sealing material.
18. The collapsible medical device of claim 15 , wherein the gasket includes an antithrombogenic coating thereon.
19. A method of forming a collapsible medical device for occluding a trans-septal hole, the method comprising:
introducing a braided fabric onto one or more mandrels;
heat-setting the braided fabric on the one or more mandrels to form a tubular structure with a proximal disc-shaped portion adjacent to a proximal end of the structure and a distal disc-shaped portion adjacent to a distal end of the structure and a cylindrical segment therebetween, wherein proximal free wire ends of the braided fabric extend longitudinally proximally from the proximal disc-shaped portion to the proximal end of the tubular structure and distal free wire ends extend longitudinally distally from the distal disc-shaped portion to the distal end of the tubular structure, the proximal and distal free wire ends and the cylindrical segment collectively defining an open lumen through the tubular structure;
immobilizing the proximal and distal free wire ends of the tubular structure;
inserting a gasket through the open lumen into the tubular structure, wherein, once inserted, the gasket extends into and occupies at least a portion of the open lumen defined by the proximal or distal free wire ends; and
securing the gasket to the tubular structure.
20. The method of claim 19 , further comprising:
attaching an additional component sized and configured to interface with a delivery device to the proximal free wire ends within the open lumen.