US-12623015-B2 - Multi-lumen implantable device

Abstract

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.

Inventors

• Bryan W. Tillman
• Youngjae Chun

Assignees

• University of Pittsburgh—of the Commonwealth System of Higher Education

Dates

Publication Date

20260512

Application Date

20210122

Claims (19)

1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 10 . The multi-lumen implantable device of claim 1 , wherein the at least one non-porous liner comprises a non-fluid permeable material.
11. 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. 12 . The multi-lumen implantable device of claim 1 , wherein the frame comprises Nitinol.
13. 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. 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. 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. 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. 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. 18 . The method of claim 14 , wherein the therapeutic agent is an aneurysm stabilizing therapeutic agent.
19. 19 . The method of claim 14 , wherein the therapeutic agent is a therapeutic agent for treating a condition of the blood vessel.

Description

CROSS REFERENCE TO RELATED APPLICATION This application is the U.S. National Stage of International Application No. PCT/US2021/014661, filed Jan. 22, 2021, which was published in English under PCT Article 21 (2), which in turn claims the benefit of U.S. Provisional Application No. 62/970,023 filed Feb. 4, 2020, which is incorporated by reference herein in its entirety. ACKNOWLEDGEMENT OF GOVERNMENT SUPPORT This invention was made with government support under Grant No. EB022591 awarded by the National Institutes of Health. The government has certain rights in the invention. FIELD The present application concerns embodiments of a multi-lumen implantable device for delivering a therapeutic agent to a blood vessel of a patient. BACKGROUND In the U.S., over 120,000 patients are in need of an organ transplant. It has been reported that only about 28,000 people received organ transplants organs in 2012 in the U.S. As a result, an average of 18 patients will die each day awaiting an organ transplant. Furthermore, the economic burden of kidney dialysis while awaiting transplant is significant, costing nearly S40 billion dollars a year in the U.S. alone. Organs recovered from living donors and those donated after brain death (DBD) (also referred to as “heartbeating donation” (HBD)) represent controlled situations where organs can be carefully exposed and cooled immediately at the time of recovery. This rapid cooling allows the highest preservation of function. Donation after cardiac death (DCD) (also referred to as “non-heartbeating donation” (NHBD)) represents a growing source of organs but presents unique challenges with regard to adequately preserving organ function just prior to transplant. Organs (e.g., kidneys) from all donor types are susceptible to warm ischemia, which is caused by reduced blood flow or the cessation of blood flow to organs and can result in significant loss of organ function. DCD donors are particularly susceptible to rather long warm ischemia times compared to DBD donors because DCD donors can experience relatively long periods of low blood pressure that is inadequate for organ perfusion prior to actual cardiac death, such as after the DCD donor is removed from life support. Needless to say, maneuvers that expedite cardiac death are prohibited. Moreover, in order to ensure that brain damage after cardiac arrest is irreversible, transplant teams must wait a predetermined time period prior to commencing the procedure for removing an organ from the DCD donor. This time period typically is referred to as a “no-touch” time period and on average is at least five minutes from the time of pronounced cardiac death. Consequently, warm ischemia times of about 10-40 minutes have been documented for DCD donors. As a result of these delays, warm ischemia can result in significant loss of organ function. Additionally, cardiovascular disease represents one of the most substantial causes of both death and disability worldwide. The delivery of potential therapies to blood vessels to treat cardiovascular disease can have several challenges. First, usually only a segment of vessel is in need of treatment, yet intravenous drugs are distributed throughout the entire body. The high volume of drug required for such treatments can result in increased costs and toxicity to the body (due to the drug being in the entire circulation). Another approach for drug delivery to a vessel for treatment includes utilizing a drug eluting stent or balloon, placed in the vessel. However, only a fraction of the drug may be delivered to the target vessel while the rest is lost to the circulation. In the case of drug eluting balloons, the exposure time to the drug is dependent on balloon inflation time, which, in turn, can lead to interval ischemia. Accordingly, a need exists for delivering candidate therapeutic agents (e.g., drugs) to target vessels for the treatment of vascular disease (e.g., for aortic aneurysms, calcified vessels, or restenotic vessels), without the therapeutic agents being distributed to the entire circulation and without increased risk of distal ischemia during drug delivery. SUMMARY The present disclosure concerns embodiments of a multi-lumen (e.g., chamber) implantable device that can be used to deliver a therapeutic agent to a desired blood vessel in a patient without the therapeutic agent being distributed to undesired locations in the patient's circulation. In particular embodiments, the multi-lumen device comprises a radially expandable frame (e.g., stent) and is configured to deliver a therapeutic agent to a portion of a blood vessel in a patient while allowing blood to continue to flow through the blood vessel and blocking the therapeutic agent from being delivered to another portion of the blood vessel. In one representative embodiment, an implantable device can include: 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 se