AORTIC ARCH BARORECEPTOR IMPLANTS FOR TREATMENT OF HYPERTENSION
Implant devices for hypertension and methods of treatment are provided. Implant devices are configured for placement in a target region of an aortic arch of the patient, thereby engaging arterial walls in the target region sufficiently to stretch and/or tension arterial walls, thereby inducing the baroreflex response. Such implants can include one or more expandable structures configured to engage an elongated target region in the aortic arch. The target region can extend along a majority of the aortic arch including a cylindrical segment of aortic arch between the left common carotid artery and the left subclavian artery. An elongated target zone can further extend at least between the brachiocephalic artery takeoff and the left subclavian artery takeoff. Such embodiments can utilize one or more expandable structures with a non-circular cross-section that stretch and reshape the arterial walls to induce tension in the arterial walls, thereby generating a robust baroreflex response.
1 . An implant for treating hypertension in a patient, the implant comprising:
an implant having a collapsed configuration for advancement through a vasculature of the patient and an expanded configuration for engagement of an arterial wall within an aortic arch of the patient,
wherein the entire implant dimensioned such that, when deployed in the aortic arch, has a length of 70 mm or greater and the implant engages the arterial walls of the aorta and extends along a target zone that extends at least between the left common carotid artery takeoff and the left subclavian artery takeoff;
wherein the implant has a non-circular cross-section when expanded so as to induce wall tension along entire target zone of the aortic arch so as to induce a baroreflex response of baroreceptors in the target zone;
wherein the implant has sufficient flexibility to accommodate a curvature of the aortic arch along the elongated zone; and
wherein any side openings in the implant are sufficiently large to allow lateral blood flow therethrough to any side branches and exposes the arterial walls to pulsatile blood flow.
2 . The implant device of claim 1 wherein the implant comprises one or more expandable structures.
3 . The implant device of claim 2 wherein the implant is dimensioned so that the arterial tissues engaged by the pair of struts stretches the arterial wall in between the struts by at least 20%.
4 . The implant device of claim 1 wherein the implant is dimensioned so that a greatest lateral dimension is greater than 25 mm.
5 . The implant device of claim 1 wherein the implant is dimensioned so that a greatest lateral dimension is between 30 mm and 40 mm.
6 . The implant device of claim 1 wherein the implant is self-expandable.
7 . The implant device of claim 6 wherein the implant is formed, at least partly, of Nitinol.
8 . The implant device of claim 1 wherein the implant is balloon expandable.
9 . The implant device of claim 1 wherein the implant comprises a one or more wires defining a design having a length greater than a lateral dimension thereof.
10 . The implant device of claim 9 wherein the implant is formed of one or more wires braided in a meandering, sinusoidal or zig-zag design to form a circumferential band.
11 . An implant for treating hypertension in a patient, the implant comprising:
an implant having a collapsed configuration for advancement through a vasculature of the patient and an expanded configuration for engagement of an arterial wall within an aortic arch of the patient,
wherein the implant is dimensioned such that, when deployed in the aortic arch, has a length of at least 60 mm and the implant engages the arterial walls of the aorta and extends along a target zone that includes a region extending at least between the brachiocephalic artery takeoff and the left subclavian artery takeoff;
wherein the implant has a non-circular cross-section when expanded along its entire length so as to induce wall tension along entire target zone of the aortic arch so as to induce a baroreflex response of baroreceptors in the target zone;
wherein the implant has sufficient flexibility to accommodate a curvature of the aortic arch along the elongated zone; and
wherein any side openings in the implant are sufficiently large to allow lateral blood flow therethrough to any side branches and exposes the arterial walls to pulsatile blood flow.
12 . The implant device of claim 11 wherein the non-circular cross-section is elliptical.
13 . The implant device of claim 11 wherein the non-circular cross-section is a regular polygonal shape.
14 . The implant device of claim 11 wherein the non-circular cross-section is constant along the entire length of the implant.
15 . The implant device of claim 11 wherein the implant comprises at least one expandable structure is dimensioned so that a greatest lateral dimension is between 30-80 mm.
16 . The implant device of claim 15 wherein a total length of the implant is between 60-90 mm.
17 . The implant device of claim 11 wherein the implant is self-expandable.
18 . The implant device of claim 11 , wherein the implant is woven or braided from one or more wires.
19 . The implant device of any claim 18 , wherein the one or more wires are Nitinol.
20 . The implant device of any claim 18 , wherein, in the expanded configuration, the implant design has a plurality of interstitial openings each having an area of 9 mm 2 or greater to allow blood flow therethrough and expose arterial walls to pulsatile blood flow.
21 . A method for treating hypertension in a patient, said method comprising:
deploying an implant within an aortic arch of the patient, the implant having a collapsed configuration for advancement through a vasculature of the patient and an expanded configuration for engagement of an arterial wall within an aortic arch of the patient, the implant having a length of at least 60 mm;
engaging the arterial wall with the implant in the expanded configuration along a target zone that includes a region that extends at least between the brachiocephalic artery takeoff and the left subclavian artery takeoff, wherein the implant has a non-circular cross-section when expanded thereby inducing wall tension along the target zone in the aortic arch; and
exposing a majority of the arterial wall along the target zone to pulsatile blood flow side openings of the expandable structures so as to sustain the baroreflex response induced by the implant long-term.
22 . The method of claim 21 wherein the non-circular cross-section is elliptical.
23 . The method of claim 21 wherein the non-circular cross-section is a regular polygonal shape.
24 . The method of claim 21 wherein the non-circular cross-section is constant along the entire length of the implant.
25 . The method of claim 21 wherein the length is between 60-100 mm.
26 . The method of claim 25 wherein the implant is dimensioned so that a greatest lateral dimension is greater than 25 mm.
27 . The method of claim 21 wherein the implant is self-expandable.
28 . The method of claim 21 wherein the implant is a woven or braided from one or more wires.
29 . The method of claim 28 wherein the one or more wires are Nitinol.
30 . The method of claim 28 , wherein, in the expanded configuration, the implant design includes a plurality of interstitial openings each having an area of 9 mm 2 or greater to allow blood flow therethrough to any lateral arteries in the aortic arch and to expose arterial walls to pulsatile blood flow.