Multi-lumen implantable device
View Patent ↗A multi-lumen implantable device configured to deliver a therapeutic agent to a selected portion of a blood vessel is disclosed. As one example, an implantable device includes a first lumen configured to flow blood from an upstream end to a downstream end of the device when implanted in a blood vessel; a second lumen fluidly separated from the first lumen and configured for introducing a therapeutic agent to a selected, first portion of a wall of the blood vessel, between the upstream end and the downstream end of the device; and at least one sealing member configured to block the therapeutic agent from entering a second portion of the wall of the blood vessel, between the upstream end and the downstream end of the device.
1 . A multi-lumen implantable device configured to be implanted in a blood vessel, comprising:
a radially expandable frame covered with a non-porous liner, the radially expandable frame including a flared, first end portion, a flared, second end portion, and a central portion arranged between the first end portion and the second end portion, in an axial direction relative to a central longitudinal axis of the device, the central portion having a first indented portion that indents radially inward, toward the central longitudinal axis, from the first end portion and the second end portion, forming a cavity on an exterior of the covered frame, between the first end portion and the second end portion, wherein the cavity extends partially around a circumference of the device, along the central portion of the device;
a first lumen configured to flow blood from the first end portion, through the central portion, and to the second end portion, the first lumen formed by an inner surface of the non-porous liner; and
a second lumen formed within the cavity, between an outer surface of the non-porous liner and a first portion of an inner wall of the blood vessel when the device is implanted in the blood vessel, wherein the second lumen is fluidly separated from the first lumen by the non-porous liner and is configured to deliver a therapeutic agent to the first portion of the inner wall of the blood vessel, and wherein the non-porous liner is configured to block the therapeutic agent from flowing to a second portion of the inner wall of the blood vessel, between the first end portion and the second end portion of the device; and
a perfusion conduit defining a perfusion lumen fluidly coupled to the second lumen and configured to extend outside a body of a patient, wherein the perfusion conduit extends through the second end portion of the frame, through the non-porous liner covering the second end portion and into the second lumen, such that an end of the perfusion conduit is arranged within the second lumen,
wherein the frame comprises a docking site comprising a cylindrical extension portion extending outward from the second end portion of the frame into the second lumen, and wherein the perfusion conduit is a separate component from the frame and is configured to be inserted into the cylindrical extension portion via a guidewire.
2 . The device of claim 1 , wherein the cavity is a first cavity and further comprising a third lumen formed within a second cavity formed by a second indented portion of the central portion which indents radially inward from the first end portion and the second portion, at a location that is radially offset from the first cavity, wherein the third lumen is formed within the second cavity, between outer walls of the non-porous liner and the inner wall of the blood vessel when the device is implanted in the blood vessel.
3 . The device of claim 1 , further comprising an additional radially expandable frame arranged within the first cavity and connected to the non-porous liner.
4 . The device of claim 1 , wherein a portion of the non-porous liner covers a non-indented portion of the central portion of the frame, which is not indented relative to the first end portion and the second end portion and is configured to seal against the second portion of the inner wall of the blood vessel to block the therapeutic agent from flowing to the second portion of the inner wall of the blood vessel.
5 . The multi-lumen implantable device of claim 1 , wherein the second lumen is arranged radially offset from the first lumen and adjacent to a central portion of the first lumen.
6 . The multi-lumen implantable device of claim 1 , wherein the first end portion and second end portion of the frame have a first diameter and are adapted to seal against the wall of the blood vessel, and wherein the first end portion and second end portion are spaced apart from one another, in an axial direction, by the central portion.
7 . The multi-lumen implantable device of claim 6 , wherein a central portion of the first lumen arranged in the central portion of the frame has a second diameter that is smaller than the first diameter, and wherein the central portion of the first lumen is radially offset from the central longitudinal axis of the device.
8 . The multi-lumen implantable device of claim 1 , wherein the non-porous liner is configured to block one or more branch vessel openings in the second portion of the wall of the blood vessel when the device is implanted in the blood vessel.
9 . The multi-lumen implantable device of claim 1 , wherein the first indented portion comprises a planar portion arranged between opposing angled portions which angle inward to the planar portion from the first end portion and the second end portion, respectively.
10 . The multi-lumen implantable device of claim 1 , wherein the at least one non-porous liner comprises a non-fluid permeable material.
11 . The multi-lumen implantable device of claim 1 , wherein the frame comprises a plurality of longitudinally oriented struts that converge into a single delivery wire or shaft at a proximal end of the device, which allows the implantable device to be recaptured and removed from the body.
12 . The multi-lumen implantable device of claim 1 , wherein the frame comprises Nitinol.
13 . The multi-lumen implantable device of claim 1 , wherein the central portion of the frame has a non-circular cross-sectional profile in a plane perpendicular to the central longitudinal axis.
14 . A method for delivering a therapeutic agent to a portion of a blood vessel via a multi-lumen implantable device, comprising:
delivering the device, in a radially compressed state, to a target location in the blood vessel, wherein the device comprises a radially expandable frame covered with a non-porous liner, the radially expandable frame including a flared, first end portion, a flared, second end portion, and a central portion arranged between the first end portion and the second end portion, in an axial direction relative to a central longitudinal axis of the device, the central portion having an indented portion that indents radially inward, toward the central longitudinal axis, from the first end portion and the second end portion, forming a cavity on an exterior of the covered frame, between the first end portion and the second end portion, wherein the cavity extends partially around a circumference of the device, along the central portion of the device, and wherein the device comprises a first lumen defined by an inner surface of the non-porous liner and extending through the first end portion, the central portion, and the second end portion;
radially expanding the device to seal the first end portion of the device against an upstream portion of the blood vessel seal the second end portion of the device against a downstream portion of the blood vessel;
flowing blood through the first lumen of the device;
forming an outer, bloodless void in the blood vessel, wherein the bloodless void is an enclosed cavity bounded by the first end portion of the device, the second end portion of the device, a first portion of a wall of the blood vessel facing the central portion of the device, and an outer surface of the non-porous liner covering the indented portion of the central portion of the frame of the device; and
delivering a therapeutic agent to the bloodless void while flowing blood through the first lumen.
15 . The method of claim 14 , wherein the central portion of the frame comprises a non-indented portion covered by the non-porous liner, and wherein when the device is radially expanded, the non-indented portion seals against a second portion of the wall of the blood vessel.
16 . The method of claim 15 , further comprising blocking the therapeutic agent from reaching the second portion of the wall of the blood vessel via the non-indented portion.
17 . The method of claim 15 , wherein the non-porous liner covering the non-indented portion of the frame covers a branch vessel extending from the blood vessel and prevents the therapeutic agent from flowing into the branch vessel.
18 . The method of claim 14 , wherein the therapeutic agent is an aneurysm stabilizing therapeutic agent.
19 . The method of claim 14 , wherein the therapeutic agent is a therapeutic agent for treating a condition of the blood vessel.