Internal closure systems and devices
Among other things, there are shown embodiments of internal members for closure of vascular wall or other bodily openings, particularly useful in closing larger holes (e.g. larger than 10 French). Embodiments create a better seal or meeting with a vascular or other tissue wall by distributing force outward from the center, and/or by including rib, groove or hinge features that allow the internal member, as it is pulled toward tissue, to close the hole and engage tissue more closely or firmly.
1. A vascular closure system, comprising:
an internal member for anchoring or sealing against an inside wall of a blood vessel, the internal member being at least partially ellipsoidal with a major axis and a minor axis, and having an exterior surface for facing away from the inside wall and an interior surface for facing the inside wall, the internal member including an elongated member for use in placement of the internal member,
the internal member having a central region and a skirt region laterally outward of the central region and monolithically joined to the central region at a hinge, the elongated member being fixed with respect to the central region and not extending through the interior surface or the exterior surface of the central region, the central region being at least partially ellipsoidal and including a portion of the exterior surface and the interior surface, the skirt region including a portion of the exterior surface and the interior surface each of which are substantially elliptically conical in form, the skirt region having a rim at a substantially constant distance from the hinge, the exterior surfaces of the central and skirt regions joining at the hinge and forming the exterior surface of the internal member, the interior surfaces of the central and skirt regions joining at the hinge to form an angle in the interior surface of the internal member, wherein in an initial unstressed configuration the exterior surface is convex in the central region, inward-bending at the hinge, and linear in cross-section along the skirt region, and the interior surface is concave in the central region, convex at the hinge, and linear in cross-section along the skirt region,
wherein the internal member is adapted to initially bend substantially at or outside the hinge without substantially changing the shape of the central region, and wherein the internal member has an area inside of the hinge which is configured to be greater than an area of a hole in the inside wall over which the internal member will be placed.
2. The system of claim 1 , wherein the elongated member is attached centrally to the interior surface of the internal member.
3. The system of claim 1 , further comprising a plurality of the elongated members fixed to the interior surface of the internal member.
4. The system of claim 3 , wherein
the plurality of elongated members are arranged symmetrically across the major axis, wherein the plurality of elongated members are non-orthogonal to the interior surface at respective points at which the plurality of elongated members engage the internal member.
5. The system of claim 4 , wherein the plurality of elongated members each form an acute angle facing the major axis at the respective points at which the plurality of elongated members engage the internal member.
6. The system of claim 4 , wherein at least one of the plurality of elongated members includes a base in the form of an oblique cone that engages the internal member.
7. The system of claim 4 , wherein the internal member includes at least one guide defining an opening generally directed toward the major axis, and wherein at least one of the plurality of elongated members is fixed to the internal member within the opening of the guide.
8. The system of claim 4 , wherein the plurality of elongated members includes at least first, second, third and fourth elongated members, and wherein the first and second elongated members are symmetric with each other across the major axis, the third and fourth elongated members are symmetric with each other across the major axis, the first and third elongated members are symmetric with each other across the minor axis, and the second and fourth elongated members are symmetric with each other across the minor axis.
9. The system of claim 1 , wherein the hinge is a living hinge.
10. The system of claim 1 , wherein the central region has a central point on the exterior surface having a tangent plane, and wherein in the initial unstressed configuration, the rim is in a plane parallel to the tangent plane, and the interior surface at the hinge is between the plane of the rim and the tangent plane.
11. The system of claim 1 , wherein the internal member has a first tensioned configuration after application of an amount of force in which the skirt region is flexed so that the skirt region is configured to press against the inside wall but the exterior surface and interior surface of the central region remain respectively convex and concave, and a second tensioned configuration to be achieved after the first tensioned configuration in which the central region is at least partially inverted so that the interior surface in the central region is configured to engage the inside wall and the exterior surface in the central region is concave.
12. The system of claim 1 , wherein the internal member is adapted to remain in place with respect to the blood vessel after a medical procedure is completed.
13. The system of claim 12 , wherein the internal member is of biocompatible material that can be broken down in vivo over time to allow natural healing and closure to get underway.
14. The system of claim 1 , wherein the elongated member does not have a longitudinal lumen.
15. The system of claim 14 , wherein the elongated member is one of a thin rod, wire or filament.