Trans-septal closure and port device
A septal closure and port device for implantation in the atrial septum of a patient's heart includes an expandable frame with a central portion defining a lumen, and first and second opposing end portions. The frame can expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can also have a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member permits a medical instrument to be inserted through the lumen and into the left atrium, for performing a subsequent medical procedure in the left side of the heart.
1. A septal closure and port device for implantation in an atrial septum of a patient's heart, comprising:
an expandable frame comprising a central portion defining a lumen, and first and second opposing end portions extending from opposite ends of the central portion, the frame configured to expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion and can compress the atrial septum therebetween; and
a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame, the valve member configured to permit a medical instrument inserted in the right atrium to pass through the lumen and the valve member and into the left atrium,
wherein the frame comprises a plurality of metal frame members, and each of the first and second end portions of the frame comprises a plurality of circumferentially spaced fingers formed by the metal frame members.
2. The device of claim 1 , wherein the frame members are encapsulated in a polymeric material.
3. The device of claim 1 , wherein the first and second end portions of the frame comprise annular flanges that extend substantially perpendicular to the central portion of the frame.
4. The device of claim 3 , further comprising fabric strips covering outer peripheral edge portions of the flanges to induce tissue in-growth with the covered portions of the flanges.
5. The device of claim 4 , wherein each flange comprises an inner surface area bounded by a respective fabric strip, the inner surface area formed from a polymeric material that induces relatively less tissue in-growth than the fabric strip.
6. The device of claim 1 , wherein the valve member comprise a plurality of flaps, each comprising an angular segment having an outer circumferential edge portion and two radially extending edge portions, the circumferential edge portion secured to the first end portion of the frame and each radially extending edge portion placed in an overlapping relationship with an adjacent radially extending edge portion of an adjacent flap, wherein the medical instrument can be inserted through the flaps to access the left atrium.
7. The device of claim 1 , wherein the valve member comprises a plurality of circular valve elements layered against each other, each valve element having an aperture or one or more slits to permit passage of the medical instrument through the valve elements.
8. The device of claim 7 , wherein the valve member is configured to block the flow of blood between the left atrium and right atrium in both directions when a medical instrument is not inserted through the valve member.