Systems for aortic repair and aortic valve replacement, and associated devices and methods

Abstract

Aortic valve and aortic treatment systems and associated devices and methods are disclosed herein. An aortic valve and aortic treatment system configured in accordance with embodiments of the present technology can include one or more devices configured to be implanted at least partially within the proximal aorta to treat aneurysms and / or dissections in the aorta and to interface with an aortic valve replacement, such as a transcatheter aortic valve replacement (TAVR) device, to provide a total treatment of the ascending aorta from the aortic valve. In some embodiments, an aortic valve and aortic treatment system includes an aortic repair device configured to be implanted in the ascending aorta to route blood past a diseased portion thereof, and a coupler device configured to be implanted proximal of the aortic repair device and to couple a TAVR device to the aortic repair device.

Description

Attomey Docket No.: 144690.8OO6.WOOO185652453 1SYSTEMS FOR AORTIC REPAIR AND AORTIC VALVE REPLACEMENT, AND ASSOCIATED DEVICES AND METHODSREFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.63 / 755,430, filed February 7, 2025, and titled “SYSTEMS FOR AORTIC REPAIR AND AORTIC VALVE REPLACEMENT, AND ASSOCIATED DEVICES AND METHODS,” and the benefit of U.S. Provisional Patent Application No. 63 / 755,440, filed February 7, 2025, and titled “SYSTEMS FOR AORTIC REPAIR AND AORTIC VALVE REPLACEMENT, AND ASSOCIATED DEVICES AND METHODS,” both of which are incorporated herein by reference in their entirety.

[0002] Additionally, some aspects of the present technology can include features generally similar or identical to, and / or can operate in a generally similar or identical manner to, any of the aortic repair devices, delivery systems, methods, and / or the like described in detail in the following U.S. patent applications, each of which is incorporated by reference in its entirety:• U.S. Patent Application No. 18 / 179,254, titled “DEVICES FOR AORTIC REPAIR, AND ASSOCIATED SYSTEMS AND METHODS,” and filed March 6, 2023:• U.S. Patent Application No. 18 / 202,853, titled “FENESTRATION DEVICES, SYSTEMS, AND METHODS FOR AORTIC ARCH REPAIR,” and filed May 26, 2023;• U.S. Patent Application No. 18 / 784,740, titled “DELIVERY SYSTEMS FOR AORTIC ARCH REPAIR DEVICES, AND ASSOCIATED DEVICES AND METHODS,” filed July 25, 2024; and / or• U.S. Patent Application No. 18 / 793,715, titled “DEVICES FOR AORTIC REPAIR, AND ASSOCIATED SYSTEMS AND METHODS,” and filed August 2, 2024.TECHNICAL FIELD

[0003] The present technology is directed to devices, systems, and methods for repairing a diseased aorta and / or aortic valve, and more particularly to systems including one or more devices configured to be implanted at least partially within the proximal aorta to treat aneurysms, dissections, and / or other diseases states of the aorta and to interface with an aortic valveAttorney Docket No.: 144690.8006.WO00185652453 1replacement, such as a transcatheter aortic valve replacement (TAVR) device, to provide a total treatment of the ascending aorta from the aortic valve.BACKGROUND

[0004] Aneurysms, dissections, penetrating ulcers, intramural hematomas, and / or transections may occur in blood vessels, and most typically occur in the aorta and peripheral arteries. A diseased region of the aorta may extend into areas having vessel bifurcations or segments of the aorta from which smaller “branch” arteries extend.

[0005] The diseased region of the aorta and other vessels can be bypassed with a stent graft placed inside the vessel to span the diseased region. The stent graft can effectively seal off the diseased region from further exposure to blood flow, inhibiting or preventing the aneurysm, dissection, or other type of diseased region from worsening. However, the use of stent grafts to internally bypass a diseased region of a vessel is not without challenges. In particular, care must be taken so that the stent graft does not cover or occlude critical branch vessels or other structures, yet the stent graft must adequately seal against the healthy regions of the vessel wall and remain open to provide a flow conduit for blood to flow past the diseased region.

[0006] Aortic valve stenosis is a condition in which the aortic valve, located between the left ventricle of the heart and the aorta, becomes narrowed and restricts blood flow from the heart to the rest of the body. Aortic valve regurgitation, also known as aortic insufficiency, is a condition in which the aortic valve does not close properly, allowing blood to flow backward from the aorta into the left ventricle of the heart. Both aortic valve stenosis and regurgitation can lead to various symptoms and complications if left untreated.

[0007] Aortic valve stenosis and regurgitation can sometimes be treated via transcatheter aortic valve replacement (TAVR), which is a minimally invasive surgical procedure used to replace a narrowed aortic valve with a prosthetic valve (TAVR device). This procedure is an alternative to open-heart surgery and is particularly beneficial for patients who are considered high-risk for traditional surgery. During TAVR, a catheter is inserted through the femoral artery (transfemoral approach), the subclavian artery, directly through the aorta (transaortic approach), or other anatomies, with a TAVR device compressed therein. When properly positioned at the diseased aortic valve, the TAVR device is expanded and released to push the native valve leaflets aside and take over the function of regulating blood flow between the left ventricle and the aorta._ _Attomey Docket No.: 144690.8OO6.WOOO185652453 1

[0008] TAVR devices can be self-expandable, balloon-expandable, and / or mechanically -expandable. There exists many commercially available TAVR devices. Figure 1 A, for example, includes perspective side views of several existing TAVR devices categorized by their expandable property, current availability, and manufacturer. Figure IB includes several additional perspective side views of existing TAVR devices and lists select features and attributes of such TAVR devices.

[0009] Frequently, patients with a diseased aortic valve also have a diseased region of the aorta and vice versa. For example, aortic valve stenosis and aortic valve regurgitation are often accompanied by dilation of the ascending aorta. Likewise, dissections or aneurysms in the ascending aorta can reach down to, at, or near the aortic valve — comprising the valve’s function. The disease states of the aorta and the aortic valve can be different in extent, dimension, and / or physiologic function. Accordingly, it would be advantageous to treat the aortic valve and the aorta together in the same procedure to provide a total treatment from the aortic valve through, at least, the ascending aorta.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0011] Figure 1A includes perspective side views of several existing TAVR devices categorized by their expandable property and current availability.

[0012] Figure IB includes several additional perspective side views of existing TAVR devices and lists select features and attributes of such TAVR devices.

[0013] Figures 2A and 2B are side views of a diseased aorta and surrounding anatomy in which a medical device, such as an aortic repair device, can be implanted in accordance with embodiments of the present technology.

[0014] Figures 3A and 3B are side cross-sectional views of a diseased aorta in which a medical device, such as an aortic repair device, can be implanted in accordance with embodiments of the present technology.

[0015] Figure 4 is a side cross-sectional view of a diseased aorta and / or diseased aortic valve in accordance with embodiments of the present technology.Attomey Docket No.: 144690.8OO6.WOOO185652453 1

[0016] Figures 5A-5C are perspective views of an aortic repair device, a coupler device, and a transcatheter aortic valve replacement (TAVR) device, respectively, in accordance with embodiments of the present technology.

[0017] Figures 6A-6C are side views of a first stage, a second stage, and a third stage, respectively, of a procedure to implant the components of Figures 5A-5C in a patient in accordance with embodiments of the present technology.

[0018] Figure 7 is a side view of an aortic valve and aortic treatment system implanted within a patient in accordance with embodiments of the present technology.

[0019] Figure 8A is a side view of a stent graft device in accordance with embodiments of the present technology.

[0020] Figure 8B is a side view of the stent graft device of Figure 8A in accordance with embodiments of the present technology in which a fabric -only region has a bulbous shape.

[0021] Figure 8C is a side view of the stent graft device of Figure 8A in accordance with embodiments of the present technology in which the fabric-only region and a flared leading end portion are omitted.

[0022] Figures 9A-9C are top views of an internal valve of a stent graft device in accordance with embodiments of the present technology.

[0023] Figures 10 A- 10C are top views of an internal valve of a stent graft device during different deployment stages in accordance with embodiments of the present technology.

[0024] Figures 11A-11C are top views of a leaflet of an internal valve of a stent graft device in accordance with embodiments of the present technology.

[0025] Figure 12 is a side view of a stent graft device in accordance with embodiments of the present technology.

[0026] Figure 13 is a side view of a stent graft device in accordance with embodiments of the present technology.

[0027] Figure 14A is a side view of a stent graft device in accordance with embodiments of the present technology.

[0028] Figures 14B and 14C are enlarged views of a coupling between a release wire and a stabilizing runner of the stent graft device of Figure 14A in accordance with embodiments of the present technology.Attomey Docket No.: 144690.8OO6.WOOO185652453 1

[0029] Figure 15 is a side view of a stent graft device positioned within an aorta in accordance with embodiments of the present technology.

[0030] Figure 16 is a side view of an expandable mesh anchor coupled to a guidewire in accordance with embodiments.

[0031] Figure 17 is a side view of a stent graft device positioned within an aorta in accordance with embodiments of the present technology.

[0032] Figures 18A and 18B are a side view and a top view, respectively, of a stent graft device positioned within an aorta in accordance with embodiments of the present technology.

[0033] Figure 19 is a side view of a temporary valve device in accordance with embodiments of the present technology.

[0034] Figure 20 is a side view of an aortic valve and aortic treatment system positioned within an aorta in accordance with embodiments of the present technology.

[0035] Figure 21 is a side view of an aortic valve and aortic treatment system positioned within an aorta in accordance with embodiments of the present technology.

[0036] Figure 22 is a side view of an aortic valve and aortic treatment system positioned within an aorta in accordance with embodiments of the present technology.

[0037] Figure 23A is a perspective side view of a coupler device positioned within an aorta and an aortic valve in accordance with embodiments of the present technology.

[0038] Figure 23B is a perspective side view of coupler device positioned within an aorta and an aortic valve in accordance with embodiments of the present technology.

[0039] Figures 24A and 24B are side views of an aortic valve and aortic treatment system in a deployment position and a deployed position, respectively, within an aorta in accordance with embodiments of the present technology.

[0040] Figures 25A and 25B are side views of an aortic valve and aortic treatment system in a deployment position and a deployed position, respectively, within an aorta in accordance with embodiments of the present technology.

[0041] Figure 26A is a perspective view of an aortic valve and aortic treatment system in accordance with embodiments of the present technology.Attorney Docket No.: 144690.8OO6.WOOO185652453 1

[0042] Figures 26B-26D are perspective views of an aortic repair device, a coupler device, and a transcatheter aortic valve replacement (TAVR) device, respectively, of the aortic valve and aortic treatment system of Figure 26A in accordance with embodiments of the present technology.

[0043] Figure 27A is a perspective view of an aortic valve and aortic treatment system in accordance with embodiments of the present technology.

[0044] Figure 27B is a perspective side view of a TAVR device of the aortic valve and aortic treatment system of Figure 27 A.

[0045] Figures 28A-28C are side views of a first stage, a second stage, and a third stage, respectively, of a procedure to implant the aortic valve and aortic treatment system of Figure 26A or the aortic valve and aortic treatment system of Figure 27A in a patient in accordance with embodiments of the present technology.

[0046] Figure 29 is a side view of an aortic valve and aortic treatment system implanted within a patient in accordance with embodiments of the present technology.

[0047] Figures 3OA-3OE are perspective side views of different stages of a delivery system used to deploy an aortic repair device and / or a coupler device within an aorta in accordance with embodiments of the present technology.

[0048] Figure 31 A is a perspective side view of the delivery stage shown in Figure 30D and further including a TAVR delivery system inserted along an open path through the aortic repair device and / or the coupler device in accordance with embodiments of the present technology.

[0049] Figure 3 IB is a perspective side view of the delivery stage shown in Figure 30E) and further including the TAVR delivery system inserted along the open path through the aortic repair device and / or the coupler device in accordance with embodiments of the present technology.DETAILED DESCRIPTION

[0050] The present technology is directed to devices, systems, and methods for repairing a diseased aorta and / or aortic valve. In some embodiments, an aortic valve and aortic treatment system includes one or more devices configured to be implanted at least partially within the proximal aorta to (i) treat aneurysms and / or dissections in the aorta and (ii) interface with anAttomey Docket No.: 144690.8OO6.WOOO185652453 1aortic valve replacement, such as a transcatheter aortic valve replacement (TAVR) device, to provide a total treatment of the ascending aorta from the aortic valve. In some embodiments, an aortic valve and aortic treatment system includes an aortic repair device configured to be implanted in the ascending aorta to route blood past a diseased portion thereof, and a coupler device configured to be implanted proximal of the aortic repair device and to couple a TAVR device to the aortic repair device.

[0051] Specific details of several embodiments of the present technology are described herein with reference to Figures 1A-31B. The present technology, however, can be practiced without some of these specific details. In some instances, well-known structures and techniques often associated with catheter-based delivery systems, implantable repair devices, and the like, have not been shown in detail so as not to obscure the present technology. Although many of the embodiments are described below with respect to medical devices, systems, and methods treating an aorta and an aortic valve, other applications and other embodiments in addition to those described herein are within the scope of the technology. For example, the present technology may be used for the treatment of different other vessels alone or in combination with other valves. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein, and that features of the embodiments shown can be combined with one another. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described below with reference to the Figures.

[0052] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the disclosure. Certain terms can even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.

[0053] The accompanying Figures depict embodiments of the present technology and are not intended to be limiting of its scope. The sizes of various depicted elements are not necessarily drawn to scale, and these various elements can be arbitrarily enlarged to improve legibility. Component details can be abstracted in the Figures to exclude details such as position of components and certain precise connections between such components when such details are unnecessary for a complete understanding of how to make and use the present technology. ManyAttomey Docket No.: 144690.8OO6.WOOO185652453 1of the details, dimensions, angles, and other features shown in the Figures are merely illustrative of particular embodiments of the disclosure. Accordingly, other embodiments can have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.

[0054] When used with reference to an aortic repair device, coupler device, and / or stent graft device, the term “distal” can reference a portion of the device positioned and / or configured to be positioned farther from the heart and downstream in the path of blood flow, while the term “proximal” can reference a portion of the device positioned and / or configured to be positioned closer to the heart and upstream in the path of blood flow. Similarly, when used with reference to a TAVR device, the term “distal” can reference a portion of the TAVR device positioned and / or configured to be positioned nearer to the aorta (farther from the left ventricle), and downstream in the path of blood flow, while the term “proximal” can reference a portion of the TAVR device positioned and / or configured to be positioned farther from the aorta (in and / or nearer to the left ventricle) and upstream in the path of blood flow. Tn contrast, when used with reference to a catheter subsystem or delivery procedure, the term “distal” can reference a portion of the catheter system farther from an operator and / or handle while the term “proximal” can reference a portion of the catheter system closer to the operator and / or handle. Accordingly, as set forth below, often a proximal portion of an aortic repair device, coupler device, stent graft device, and / or TAVR device is farther from the operator and / or handle of a catheter system used to deliver the device than a distal portion of the device. Likewise, often a distal portion of the device is closer to the operator and / or handle of the catheter system than the proximal portion.

[0055] Also, as used herein, the designations “rearward,” “forward,” “upward,” “downward,” etc., are not meant to limit the referenced component to use in a specific orientation. It will be appreciated that such designations refer to the orientation of the referenced component as illustrated in the Figures; the systems of the present technology can be used in any orientation suitable to the user.

[0056] The headings provided herein are for convenience only and should not be construed as limiting the subject matter disclosed.I. Overview

[0057] Figures 2A and 2B are side views of a diseased aorta and surrounding anatomy in which a medical device, such as an aortic repair device, can be implanted in accordance with embodiments of the present technology. Referring to Figures 2A and 2B together, the aorta isAttomey Docket No.: 144690.8OO6.WOOO185652453 1the largest vessel in the human body and carries oxygenated blood away from the left ventricle and the aortic valve of the heart for circulation to all parts of the body. The aorta is divided into different segments including the ascending aorta (which extends from the left ventricle), the aortic arch, and the descending thoracic aorta. The ascending aorta and the aortic arch can together be referred to as the “proximal aorta.’’ The aorta includes branches into several supra-aortic arteries including the brachiocephalic artery, the left common carotid artery, and the left subclavian artery — each of which extends from the aortic arch. The brachiocephalic artery is the first branch of aortic arch and feeds blood flow to the right common carotid artery and the right subclavian artery for supply to the right arm, head, and neck. It is also known as the innominate artery or the brachiocephalic trunk. The left common carotid artery is the second branch of the aortic arch and feeds blood flow to the left head and neck. The left subclavian artery is the third branch of the aortic arch and feeds blood flow to the left arm.

[0058] The diseased aorta includes an aneurysm in the ascending aorta in Figure 2A and an aneurysm in the aortic arch in Figure 2B. Aortic aneurysms are enlargements (e.g., dilations) of the aorta that weaken the aorta and increase the likelihood of rupture. Most people with aortic aneurysms do not have symptoms until the aorta ruptures, and the mortality rate after an aortic aneurysm rupture can exceed 90%. Often, aortic aneurysms are detected during routine medical testing such as chest X-rays, computed tomography (CT) imaging, ultrasound imaging of the heart, magnetic resonance imaging (MRI), and the like.

[0059] Figures 3A and 3B are side cross-sectional views of a diseased aorta in which a medical device, such as an aortic repair device, can be implanted in accordance with embodiments of the present technology. The diseased aorta includes DeBakey Type II, a smaller Type A aortic dissection contained within the ascending aorta, in Figure 3A, and a DeBakey Type I, a larger Type A aortic dissection that extends beyond the ascending aorta, in Figure 3B. Aortic dissections are tears of the intimal layer of the aorta that cause blood to dissect the intimal layer and block flow. Type A aortic dissections originate in the ascending aorta and can progressively extend from the ascending aorta, toward the aortic valve, along the aortic arch, and / or down along the descending aorta as shown in Figure 3B. Aortic dissections can be acute or chronic, with acute aortic dissections frequently causing a sudden onset of severe pain in the chest, back, and / or abdomen. Most acute aortic dissections require emergency surgery, and present about a 1% risk of death every hour for the first two days after dissection — meaning that urgent diagnosis and surgery are critical for patient treatment.Attomey Docket No.: 144690.8OO6.WOOO185652453 1

[0060] Figure 4 is a side cross-sectional view of a diseased aorta and / or diseased aortic valve in accordance with embodiments of the present technology. The diseased aortic valve can be stenosed, regurgitant, and / or in another disease state. The diseased aorta can include an aneurysm, a dissection, a dilation, and / or another disease state as discussed above. Notably, as shown in Figure 4, a patient may present with both a diseased aortic valve and also a diseased region of the aorta (ascending aorta). For example, aortic valve stenosis and aortic valve regurgitation are often accompanied by dilation of the ascending aorta. Likewise, dissections or aneurysms in the ascending aorta can reach down to, at, or near the aortic valve — comprising the function of the valve. The disease states of the aorta and the aortic valve can be different in extent, dimension, and / or physiologic function.

[0061] Some aspects of the present technology are directed to treatment systems that can be implanted within the aorta and / or the aortic valve to cooperatively treat both a disease state of the aorta (e.g., an aortic aneurysm, an aortic dilation, a Type A aortic dissection, and / or other types of disease states) and a disease state of the aortic valve (e.g., stenosis, regurgitation, and / or other types of disease states). For example, as shown schematically in Figure 4, an aortic repair device 410 can span across the origin of an aneurysm or dissection within the ascending aorta and provide one or more flow conduits for diverting blood flow away from and / or past the diseased portion. Additionally, a TAVR device 420 can be delivered to and implanted within the aortic valve to replace and treat the diseased aortic valve. The aortic repair device 410 can, together with the TAVR device 420, define an aortic treatment system 400 (which can also be referred to as a total aortic treatment system, a total aortic repair system, an aortic valve and vessel repair system, and / or the like). A distal portion of the TAVR device 420 can be coupled to a proximal portion of the aortic repair device 410 to provide a continuous flow conduit from the TAVR device past the diseased portion of the ascending aorta. Alternatively, a coupler device (e.g., as described below) can extend between the TAVR device and the aortic repair device to fluidly couple these components.II. Selected Embodiments of Systems and Methods for Aortic Repair and Aortic Valve Replacement

[0062] Figures 5A-5C are perspective views of an aortic repair device 510 (which can also be referred to as an ascending aortic repair device, an aortic prosthesis, an aortic treatment device, an aortic implant, a repair device, a medical device, and / or the like), a coupler device 530 (which can also be referred to as an ascending aortic repair device, an aortic prosthesis, anAttorney Docket No.: 144690.8006.WO00185652453 1aortic treatment device, an aortic implant, a repair device, a medical device, and / or the like), and a transcatheter aortic valve replacement (TAVR) device 520 (which can also be referred to as a valve replacement, a prosthetic valve, an aortic valve replacement, a prosthetic aortic valve, an aortic valve implant, an aortic valve repair device, a medical device, and / or the like), respectively, in accordance with embodiments of the present technology. The aortic repair device 510, the TAVR device 520, and the coupler device 530 can together form an aortic valve and aortic treatment system for treating a diseased aorta and a diseased aortic valve of a patient as described in further detail below with reference to Figures 6A-6C.

[0063] Referring to Figure 5A, the aortic repair device 510 can be a stent graft having features generally similar or identical to any of the aortic repair devices described in (i) U.S. Patent Application No. 18 / 179,254, titled “DEVICES FOR AORTIC REPAIR, AND ASSOCIATED SYSTEMS AND METHODS,” and filed March 6, 2023, (ii) U.S. Patent Application No. 18 / 202,853, titled “FENESTRATION DEVICES, SYSTEMS, AND METHODS FOR AORTIC ARCH REPAIR,” and filed May 26, 2023, and / or (iii) U.S. Patent Application No. 18 / 793,715, titled “DEVICES FOR AORTIC REPAIR, AND ASSOCIATED SYSTEMS AND METHODS,” and filed August 2, 2024, each of which is incorporated herein by reference in its entirety. For example, the aortic repair device 510 can be a stent graft comprising one or more stents 515 coupled to an inner and / or outer surface of a graft material 525 via stitching (e.g., sutures) and / or other suitable attachment techniques, and can include an internal septum dividing the aortic repair device into a first flow channel for routing a first portion of blood (e.g., distally into the vessel) and a second flow channel for routing a second portion of blood (e.g., distally into a vessel branching from the aorta). The aortic repair device 510 can include a leading (e.g., first, proximal) end portion 595 that is opposite a trailing (e.g., second, distal) end portion 575. Likewise, the aortic repair device 510 can be delivered to and deployed within a diseased aorta using any of the delivery systems described in U.S. Patent Application No. 18 / 784,740, titled “DELIVERY SYSTEMS FOR AORTIC ARCH REPAIR DEVICES, AND ASSOCIATED DEVICES AND METHODS,” filed July 25, 2024, which is incorporated by reference herein in its entirety.

[0064] Referring to Figure 5B, the coupler device 530 can have some features generally similar or identical to the features of the aortic repair device 510. For example, the coupler device 530 can comprise a stent graft 570 including one or more stents 515 coupled to an inner and / or outer surface of a graft material 525 via stitching (e.g., sutures) and / or other suitable attachment techniques. The stent graft can form a body for the coupler device 530. The couplerAttomey Docket No.: 144690.8OO6.WOOO185652453 1device 530 can define / enclose a channel for routing blood therethrough. In some embodiments, the graft material 525 includes one or more fenestrations 540 configured (e.g., shaped, sized) to permit at least a portion of blood flowing through the coupler device 530 to perfuse the coronary arteries. In some embodiments, one or more additional stent grafts can be fluidly coupled to the fenestrations 540 to provide additional flow conduits from the coupler device 530 to the coronary arteries. For example, one or more wires can be inserted through the fenestrations 540 into the coronary arteries to allow tracking of separate stent grafts (e.g., osteal stents) to the coronary arteries and deployment therein. In other embodiments, the fenestrations 540 can be omitted. In the illustrated embodiment, the coupler device 530 is tubular while, in other embodiments, the coupler device 530 can have other shapes, such as flared, tapered, hourglass, etc.

[0065] In the illustrated embodiment, the coupler device 530 includes a plurality of fingers or arms 550 extending from a leading (e.g., first, proximal) end portion 580 of the coupler device 530 that is opposite a trailing (e.g., second, distal) end portion 590 of the coupler device 530. As described in greater detail below with reference to Figure 6A, the arms 550 are configured to span across the aortic valve to anchor the coupler device 530 in the aorta and inhibit or even prevent distal migration of the coupler device 530. In the illustrated embodiment, the arms 550 each terminate at a ventricle pad 560 configured to engage an anterior surface within the left ventricle. The ventricle pads 560 can have a diamond-like pattern and / or another pattern conducive to loading within a catheter. The arms 550 can be bowed to reduce a risk of damaging the aortic valve leaflets and / or to provide redundant length for varying aortic sinus height. In some embodiments, fabric or the like spans the surface of the ventricle pads 560 and / or connects the pads 560 to promote tissue ingrowth for biological migration resistance.

[0066] Referring to Figure 5C, the TAVR device 520 can be a self-expandable, balloonexpandable, or mechanically-expandable device, such as any of the existing TAVR devices shown in Figure 1A. The TAVR device 520 is configured to displace a native aortic valve and replace the function thereof.

[0067] Referring to Figures 5A-5C, the leading end portion 580 of the coupler device 530 can be coupled to the TAVR device 520 and the trailing end portion 590 of the coupler device 530 can be coupled to the aortic repair device 510. For example, the coupler device 530, the aortic repair device 510, and the TAVR device 520 can be selectively deployed such that the coupler device 530 partially overlaps (either radially inside or radially outside) the aortic repair device 510 and partially overlaps (either radially inside or radially outside) the TAVR deviceAttorney Docket No.: 144690.8OO6.WOOO185652453 1520 to provide a continuous flow path through the TAVR device 520, through the coupler device 530, and through the aortic repair device 510 for routing blood from a left ventricle, through a diseased aortic valve, and past a diseased portion of an aorta of a patient. More specifically, (i) the leading end portion 580 of the coupler device 530 can partially overlap (either radially inside or radially outside) a trailing end portion 585 of the TAVR device 520 to couple the coupler device 530 to the TAVR device 520 and (ii) the trailing end portion 590 of the coupler device 530 can partially overlap (either radially inside or radially outside) the leading end portion 595 of the aortic repair device 510 to couple the coupler device 530 to the aortic repair device 510.

[0068] Figures 6A-6C are side views of a first stage, a second stage, and a third stage, respectively, of a procedure to implant the components of an aortic treatment system 600 (“system 600”) in a patient in accordance with embodiments of the present technology. Referring to Figure 6A, in the first stage the coupler device 530 can be implanted within the ascending aorta distal to the aortic valve. The aorta and the aortic valve can be diseased. For example, in the illustrated embodiment the ascending aorta contains a dilation or aneurysm. In some embodiments, the leading end portion 580 of the coupler device 530 is positioned within the aortic sinus (also called the sinuses of Valsalva). The coupler device 530 can be rotationally aligned within the aorta such that one or more of the fenestrations 540 are aligned within one or more of the coronary arteries. The arms 550 can extend through / past the aortic valve and into the left ventricle where they can engage a superior surface of the left ventricle to inhibit or even prevent migration of the coupler device 530 in the distal direction. The arms 550 can align and “settle in” commissure posts of the native aortic valve. In some embodiments, the ventricle arms 550 are asymmetrically positioned such as to avoid pressing against and / or contacting tissue adjacent the bundle (e.g., the ventricular septum) and / or other conductive features of the heart to inhibit or even prevent interference with the electrical conduction system of the heart.

[0069] The coupler device 530 can be delivered to and deployed within the aorta using any of the methods and / or system described in detail in U.S. Patent Application No. 18 / 784,740, titled “DELIVERY SYSTEMS FOR AORTIC ARCH REPAIR DEVICES, AND ASSOCIATED DEVICES AND METHODS,” and filed July 25, 2024. For example, the coupler device 530 can be intravascularly advanced through the vasculature of a patient in a delivery position within a catheter-based delivery system to, at, within, and / or proximate the diseased aorta via any suitable intravascular path — such as an aortic approach, a transfemoral approach, a transcarotid approach, a transsubclavian approach, a transapical approach, and so on. In particular, the coupler device 530 can be delivered via a transcarotid approach through theAttomey Docket No.: 144690.8OO6.WOOO185652453 1right common carotid artery. Moreover, delivery of the coupler device 530 can include (i) capturing one or more stent tips of the coupler device 530 for safe, fine positioning, (ii) releasing the coupler device 530 in two or more stages to provide for controlled partial opening, good apposition and conformance to the wall of the aorta, and accurate final release (iii) driving forward one or more sides of the coupler device 530 to provide accurate tilt correction and squareness within the aorta, (i v) providing the open trailing end portion 590 of the coupler device 530 to provide an open aortic path and stable position, and / or (v) other features described in detail in the above-incorporated U.S. Patent Application No. 18 / 784,740.

[0070] Referring to Figure 6B, in the second stage the aortic repair device 510 can be implanted within the ascending aorta and coupled to the coupler device 530. For example, in the illustrated embodiment the aortic repair device 510 can be deployed partially within the coupler device 530 such that the leading end portion 595 of the aortic repair device 510 overlaps (e.g., radially inside) the trailing end portion 590 of the coupler device 530 to provide a continuous fluid path through the coupler device 530 and the aortic repair device 510.

[0071] The aortic repair device 510 can be delivered to and deployed within the aorta using any of the methods and / or system described in detail in the above-incorporated U.S. Patent Application No. 18 / 784,740. For example, the aortic repair device 510 can be intravascularly advanced through the vasculature of a patient in a delivery position within a catheter-based delivery system to, at, within, and / or proximate the diseased aorta via any suitable intravascular path — such as an aortic approach, a transfemoral approach, a transcarotid approach, a transsubclavian approach, a transapical approach, and so on. In particular, the aortic repair device 510 can be delivered via a transcarotid approach through the right common carotid artery. Moreover, delivery of the aortic repair device 510 can include (i) capturing one or more stent tips of the aortic repair device 510 for safe, fine positioning, (ii) releasing the aortic repair device 510 in two or more stages to provide for controlled partial opening, good apposition and conformance to the wall of the aorta, and accurate final release (iii) driving forward one or more sides of the aortic repair device 510 to provide accurate tilt correction and squareness within the aorta, (iv) providing the open trailing end portion 585 of the aortic repair device 510 to provide an open aortic path and stable position, and / or (v) other features described in the aboveincorporated U.S. Patent Application No. 18 / 784,740.

[0072] Referring to Figure 6C, in the third stage the TAVR device 520 can be implanted within the aortic valve and coupled to the coupler device 530. For example, in the illustratedAttomey Docket No.: 144690.8OO6.WOOO185652453 1embodiment the TAVR device 520 can be deployed partially within the coupler device 530 such that the trailing end portion 585 of the TAVR device 520 overlaps (e.g., radially inside) the leading end portion 580 of the coupler device 530 to provide a continuous fluid path through the TAVR device 520 and the coupler device 530. The TAVR device 520 displaces the native leaflets of the aortic valve and regulates blood flow in their place. Moreover, the TAVR device 520 exerts a radially outward force against the arms 550 of the coupler device 530 that extend through the aortic valve and / or against the leading end portion 580 of the coupler device 530 that acts to inhibit or even prevent distal migration of the coupler device 530 (and the aortic repair device 510 coupled thereto). Put differently, the expanded force of the TAVR device 520 against the coupler device 530 adds longitudinal stability to the system 600. Accordingly, once deployed, the system 600 provides a complete treatment from the aortic valve and into the ascending aorta past the diseased portion thereof.

[0073] The TAVR device 520 can be delivered to and deployed within the aortic valve via a transcarotid approach, a transsubclavian approach, a transapical approach, and so on. In particular, the TAVR device 520 can be delivered via a transfemoral approach. Referring to Figures 6A-6C, in some embodiments, the coupler device 530 and the aortic repair device 510 are delivered via a transcarotid approach while the TAVR device 520 is delivered via a transfemoral approach. In some aspects of the present technology, the different approaches allow for some or all of the components of the delivery systems used to deliver these components to be intravascularly positioned concurrently.

[0074] In some embodiments, the aortic repair device 510, the TAVR device 520, and the coupler device 530 can be delivered and deployed in different sequences. For example, the TAVR device 520 can be delivered before the coupler device 530, and the leading end portion 580 of the coupler device 530 can be deployed partially within the trailing end portion 585 of the TAVR device 520. In such embodiments, the arms of the coupler device 530 can align and “settle in” posts of the TAVR device 520 rather than in the commissure posts of the native aortic valve. Likewise, the aortic repair device 510 can be delivered before the coupler device 530, and the trailing end portion 590 of the coupler device 530 can be deployed partially within the leading end portion 595 of the aortic repair device 510.

[0075] In yet other embodiments, the aortic repair device 510 and the coupler device 530 can be integrated into a single stent graft. Figure 7, for example, is a side view of an aortic valve and aortic treatment system 700 (“system 700”) implanted within a patient in accordance withAttomey Docket No.: 144690.8OO6.WOOO185652453 1embodiments of the present technology. In the illustrated embodiment, the system 700 includes the TAVR device 520 and an aortic repair device 710 coupled to the TAVR device 520. The aortic repair device 710 integrates the aortic repair device 510 and the coupler device 530 into a single stent graft and, accordingly, is longer than the aortic repair device 510 of Figure 5A and includes a leading end portion configured to be positioned within the aortic sinus and to couple to the TAVR device 520. The ventricle arms 550 can extend from the leading end portion into the left ventricle for anchoring the aortic repair device 710. The aortic repair device 710 can include the one or more fenestrations 540 configured (e.g., shaped, sized) to permit at least a portion of blood flowing through the aortic repair device 710 to perfuse the coronary arteries.

[0076] The aortic repair device 710 can be delivered to and deployed within the aorta using any of the methods and / or system described in detail in the above-incorporated U.S. Patent Application No. 18 / 784,740. For example, the aortic repair device 710 can be intravascularly advanced through the vasculature of a patient in a delivery position within a catheter-based delivery system to, at, within, and / or proximate the diseased aorta via any suitable intravascular path — such as an aortic approach, a transfemoral approach, a transcarotid approach, a transsubclavian approach, a transapical approach, and so on. In particular, the aortic repair device 710 can be delivered via a transcarotid approach through the right common carotid artery. Moreover, delivery of the aortic repair device 710 can include (i) capturing one or more stent tips of the aortic repair device 710 for safe, fine positioning, (ii) releasing the coupler device in two or more stages to provide for controlled partial opening, good apposition and conformance to the wall of the aorta, and accurate final release (iii) driving forward one or more sides of the aortic repair device 710 to provide accurate tilt correction and squareness within the aorta, (iv) providing an open trailing end of the aortic repair device 710 to provide an open aortic path and stable position, and / or (v) other features described in detail in the above-incorporated U.S. Patent Application No. 18 / 784,740.

[0077] Figure 8A is a side view of a stent graft device 800 in accordance with embodiments of the present technology. The stent graft device 800 has a plurality of stents 815 and can function as a coupler device (e.g., the coupler device 530 of Figures 5B and 6A-6C) and / or as an aortic repair device (e.g., the aortic repair device 510 of Figures 5A, 6B, and 6C). In the illustrated embodiment, the stent graft device includes a flared leading end portion 830 (e.g., terminal zone), a radially unsupported (e.g., flaccid) fabric-only region 820A, one or more fenestrations 840 extending through the fabric-only region 820A for perfusing the coronary arteries, and an internal valve 810 that can be formed of fabric. When implanted within a patient,Attomey Docket No.: 144690.8OO6.WOOO185652453 1the leading end portion 830 can be positioned within the left ventricle and engage a wall (e.g., a superior wall) of the left ventricle to inhibit or even prevent distal migration of the stent graft device 800. The flared leading end portion 830 can have an inverted funnel shape, can be supported by a stent-like structure, and can be covered in graft material (e.g., fabric) or bare of graft material. When implanted within a patient, the fabric-only region 820A can permit radial wall motion similar to the native aortic sinus.

[0078] The fabric-only region can be tubular as shown in Figure 8A or can have other shapes. For example, Figure 8B is a side view of the stent graft device 800 of Figure 8A in accordance with additional embodiments of the present technology in which the fabric-only region 820B has a bulbous shape that, for example, substantially mirrors a shape of the aortic sinus. Likewise, the fabric-only region 820B and / or the flared leading end portion 830 can be omitted. Figure 8C, for example, is a side view of the stent graft device 800 of Figure 8A in accordance with additional embodiments of the present technology in which the fabric-only region 820A and the flared leading end portion 830 are omitted such that the stent graft device 800 as a consistent tubular shape and stent structure. In other embodiments, the stent graft device 800 can be hour-glassed shaped to, for example, promote perfusion of the coronary arteries.

[0079] The internal valve 810 can provide temporary (e.g., periprocedural) aortic valve function during delivery of an aortic valve and aortic treatment system. For example, the internal valve 810 can provide aortic valve function (e.g., closing during diastole and opening during systole) after delivery of the stent graft device 800 across the aortic valve and before implantation of a TAVR device (e.g., the TAVR device 520 of Figures 5C and 6C) at the aortic valve within the stent graft device 800. The stent graft device 800 can be implanted such that the internal valve 810 is at the same level as the aortic valve, or such that the internal valve 810 is inferior to the native aortic valve. The internal valve 810 can comprise a plurality of leaflets, and the leaflets can have one of a variety of configurations.

[0080] Figures 9A-9C, for example, are top views of the internal valve 810 in accordance with embodiments of the present technology. Referring to Figure 9A, the internal valve 810 can include two valve leaflets 910A (e.g., bicuspid) separated by a straight slit 920A. Referring to Figure 9B, the internal valve can include three triangular shaped leaflets 910B (e.g., tricuspid). Referring to Figure 9C, the internal valve can include two valve leaflets 910C (e.g., bicuspid) separated by a curved (e.g., sinusoidal) slit 920C to provide for redundant contact between theAttomey Docket No.: 144690.8OO6.WOOO185652453 1leaflets and extra contact length that can ensure apposition between the leaflets 910C during operation.

[0081] Figures 10A-10C are top views of the internal valve 810 of Figure 9C during different deployment stages in accordance with embodiments of the present technology. Referring to Figures 10A and 10B, the internal valve 810 can have the same configuration as shown in Figure 9C, and can further include a fiber and release wire mechanism comprising a fiber 1010 and a release wire 1020. In the stages shown in Figure 10A and 10B, the fiber 1010 and release wire 1020 maintain proximity between the valve leaflets 910C such that the internal valve 810 can close during diastole (Figure 10A) and partially open during systole (Figure 10B). Referring to Figure 10B, when the internal valve 810 is partially open, a crossing-catheter, guidewire, and / or TAVR delivery system can be advanced through the internal valve 810. Referring to Figure 10C, the internal valve 810 can be fully opened at operator discretion by removing (e.g., retracting) the release wire 1020 to fully open the valve and cease its operation as a temporary valve. For example, the internal valve 810 can be fully opened during initial unsheathing of a TAVR device, mid-unsheathing of the TAVR device, and / or the like.

[0082] Figures 11A-11C are top views of the leaflet 910B of the internal valve 810 of Figure 9B in accordance with embodiments of the present technology. Referring to Figures 11A-11C, the leaflet 910B can be a triangular leaflet for use in a three-leaflet (e.g., tricuspid) internal valve 810 as shown in, for example, Figure 9B. The leaflet 910B does not need to mimic that native anatomy of the aortic valve and can instead include features to facilitate crossing of the valve, possible removal of the valve, compressibility, and / or the like. The leaflet 910B can be a three-dimensional fabric flap and can have one or more reinforcement structures 1110, such as nitinol reinforcement structures. For example, the leaflet 910B can include a nitinol reinforcement structure 1110 (e.g., wire) sewn along a centerline of the leaflet 910B (Figure 11 A) or along an edge of the leaflet 910B (Figure 11B). Referring to Figure 11C, the nitinol reinforcement structure 1110 can comprise a small diameter wire that acts as a suture along the edge of the leaflet 910B. Referring to Figures 11A-11C, the force of the leaflets 910B can be relatively weak to permit insertion of a crossing-catheter, guidewire, and / or TAVR delivery system through the internal valve. The leaflets 910B can have fabric redundancy to provide a sealing function and cushion.

[0083] Figure 12 is a side view of a stent graft device 1200 in accordance with embodiments of the present technology. The stent graft device 1200 can function as a couplerAttomey Docket No.: 144690.8OO6.WOOO185652453 1device (e.g., the coupler device 530 of Figures 5B and 6A-6C) and / or as an aortic repair device (e.g., the aortic repair device 510 of Figures 5A, 6B, and 6C). In the illustrated embodiment, the stent graft device 1200 includes a plurality of nitinol petals 1210 (e.g., fingers) configured to extend into the left ventricle and to conform / appose to the left ventricle to maintain the position of the stent graft device 1200 within an aorta by inhibiting or even preventing distal migration of the stent graft device 1200. The stent graft device 1200 can include one or more fenestrations (not shown) for perfusing the coronary arteries.

[0084] Figure 13 is a side view of a stent graft device 1300 in accordance with embodiments of the present technology. The stent graft device 1300 can function as a coupler device (e.g., the coupler device 530 of Figures 5B and 6A-6C) and / or as an aortic repair device (e.g., the aortic repair device 510 of Figures 5A, 6B, and 6C). In the illustrated embodiment, the stent graft device 1300 includes a wire form 1310 (e.g., a wound wire, a braid, and / or the like) attached near a leading end portion of the stent graft device 1320. The wire form 1310 can engage a wall of an aorta (e.g., within the aortic sinus) to maintain the position of the stent graft device 1300 within the aorta by inhibiting or even preventing distal migration of the stent graft device 1300. The stent graft device 1300 can include one or more fenestrations (not shown) for perfusing the coronary arteries.

[0085] Figure 14A is a side view of a stent graft device 1400 in accordance with embodiments of the present technology. The stent graft device 1400 can function as a coupler device (e.g., the coupler device 530 of Figures 5B and 6A-6C) and / or as an aortic repair device (e.g., the aortic repair device 510 of Figures 5A, 6B, and 6C). In the illustrated embodiment, the stent graft device 1400 includes a stabilizing runner 1410 coupled to a release wire 1420. The stabilizing runner 1410 can provide temporary longitudinal stiffness to stabilize the stent graft device 1400 during other maneuvers, such as entry / exit of a TAVR delivery system through the stent graft device 1400, withdrawal of a delivery system of the stent graft device 1400, and / or the like. The runner 1410 can extend luminal or abluminal to the stent graft device 1400 and can be attached to multiple stents thereof for bidirectional stabilization. In some embodiments, the runner 1410 can be flat to enable coupling to the release wire 1420.

[0086] Figures 14B and 14C are enlarged views of the coupling between the release wire 1420 and the stabilizing runner 1410 in accordance with embodiments of the present technology. Referring to Figure 14B, the release wire 1420 can extend through an aperture 1430 in the runner 1410 and include a coiled end 1420B to releasably lock to the runner 1410. Referring to FigureAttomey Docket No.: 144690.8OO6.WOOO185652453 114C, the runner 1410 can terminate in a pocket 1440 in the graft material 525 of the stent graft device 1400, and the release wire 1420 can pass through the pocket 1440 and an aperture 1430 in the runner 1410 to releasably lock the runner 1410 to the release wire 1420. Withdrawal of the release wire 1420 permits withdrawal of the runner 1410 from the pocket 1440.

[0087] Figure 15 is a side view of a stent graft device 1500 positioned within an aorta in accordance with embodiments of the present technology. The stent graft device 1500 can function as a coupler device (e.g., the coupler device 530 of Figures 5B and 6A-6C) and / or as an aortic repair device (e.g., the aortic repair device 510 of Figures 5A, 6B, and 6C). In the illustrated embodiment, the stent graft device 1500 includes a “fish-scale” stent 1510 on an inner diameter of the stent graft device 1500 proximate a leading end portion 580 of the coupler device 530 thereof. The fish-scale stent 1510 can be bare or covered with graft material (e.g., graft material 525 of Fig. 5C) and can anchor to, for example, a trailing end portion of a TAVR device (e.g., trailing end portion 585 of TAVR device 520 of Fig. 5C).

[0088] Figure 16 is a side view of an expandable mesh anchor 1620 coupled to a guidewire 1610 in accordance with embodiments of the present technology. The guidewire 1610 can be inserted through the aorta such that the expandable mesh anchor 1620 is positioned within a coronary artery, and the expandable mesh anchor 1620 can be expanded to anchor the guidewire 1610. In some embodiments, the guidewire 1610 can extend through a fenestration (e.g., one of the fenestrations 540 of Figure 5B) in a stent graft device (not shown; e.g., a coupler device (e.g., the coupler device 530 of Figures 5B and 6A-6C) and / or an aortic repair device (e.g., the aortic repair device 510 of Figures 5A, 6B, and 6C)) such that the anchor 1620 and coupled guidewire 1610 anchors the stent graft device and inhibits or even prevents distal migration thereof during deployment. For example, the guidewire 1610 can anchor the stent graft device as a TAVR device is deployed through the stent graft device.

[0089] Figure 17 is a side view of a stent graft device 1700 positioned within an aorta in accordance with embodiments of the present technology. In the illustrated embodiment, the stent graft device 1700 includes a ring or coil 1710 embedded in or temporarily coupled to a leading end portion of the stent graft device 1720. The ring or coil 1710 can expand (temporarily or permanently) to anchor the stent graft device 1700 within the aorta and inhibit or even prevent distal migration thereof. The ring or coil 1710 can be an inflatable donut, wire ring, short apex height stent, and / or the like, and can be configured to reside below the sinotubular junction ridge at the top of the aortic sinus. The stent graft device 1700 can further comprise extension armsAttomey Docket No.: 144690.8OO6.WOOO185652453 11730 (e.g., curved wires) extending from the leading end portion of the stent graft device 1720 that pass through the aortic valve and lie between commissures thereof. The arms 1730 can be nitinol wires extending into the left ventricle to gain support along the superior surface thereof. Procedurally, guidewires 1740 can extend into the coronary arteries for position location, stabilization (e.g., in setting up for interventional treatment), and / or bailout if needed.

[0090] Figures 18A and 18B are a side view and a top view, respectively, of a stent graft device 1800 positioned within an aorta in accordance with embodiments of the present technology. Referring to Figures 18A and 18B, the stent graft device 1800 can function as a coupler device (e.g., the coupler device 530 of Figures 5B and 6A-6C) and / or as an aortic repair device (e.g., the aortic repair device 510 of Figures 5A, 6B, and 6C). Referring to Figure 18A, the stent graft device 1800 can include a crown-like structure 1810 at a trailing portion of the stent graft device 1820 that is tapered, flared, and / or curled outward to provide “bite" for migration resistance. Referring to Figure 18B, in the illustrated embodiment the stent graft device 1800 also includes a plurality of fingers 1830 (e.g., petals) configured to extend into the left ventricle through the commissures of the aortic valve and to conform / appose to the left ventricle to maintain the position of the stent graft device within an aorta by inhibiting or even preventing distal migration of the stent graft device 1800. The fingers 1830 can have a relatively large footprint (e.g., petal-shaped, ellipse-shaped) inferior to the native aortic leaflets to occupy sufficient shape to inhibit migration.

[0091] Figure 19 is a side view of a temporary valve device 1900 in accordance with embodiments of the present technology. The temporary valve device 1900 is integrated into a delivery system component used to deliver a stent graft device (e.g., the coupler device 530 of Figure 5B, aortic repair device) and is removable peri-procedurally because it is integrated into the delivery system. In some embodiments, the temporary valve device 1900 is positioned on a shaft 1910 (e.g., a separate accessory catheter) of the delivery system that extends inside the stent graft device (not included) while tracking / positioning a separate TAVR device (not included).

[0092] Figure 20 is a side view of an aortic valve and aortic treatment system 2000 (“system) positioned within an aorta in accordance with embodiments of the present technology. In the illustrated embodiment, the system 2000 includes a balloon-expandable TAVR device 2020 (“BEV device”), a coupler device 2030, and an aortic repair device 2010. The coupler device 2030 can be deployed before the BEV device 2020 and the aortic repair device 2010 andAttorney Docket No.: 144690.8OO6.WOOO185652453 1can include ventricle arms (e.g., arms 550 from Figure 5) that extend below the aortic valve. In some embodiments, a trailing portion 2090 (e.g., a trailing half) of the coupler device 2030 can be covered in graft material 2025 while a leading portion 2080 (e.g., a leading half) of the coupler device 2030 is bare 2040 (e.g., not covered in graft material). The bare portion 2040 can permit perfusion of the coronary arteries.

[0093] During delivery, the BEV device 2020 can be deployed within the coupler device 2030 (e.g., the bare portion 2040 thereof) and balloon expanded within the aortic valve. The expansion of the BEV device 2020 can push / force the coupler device 2030 against the wall of the aorta, the aortic valve, and / or the wall of the left ventricle to help maintain the position of the coupler device 2030. The aortic repair device 2010 can be deployed within the coupler device 2030 (e.g., the covered portion having graft material 525). In some embodiments, the aortic repair device 2010 is oversized relative to the aorta such that it expands within the coupler device 2030 and frictionally engages an inner surface of the coupler device 2030.

[0094] Figure 21 is a side view of an aortic valve and aortic treatment system 2100 (“system) positioned within an aorta in accordance with embodiments of the present technology. In the illustrated embodiment, the system 2100 includes a coupler device 2130 that can be coupled to a BEV device (not shown), and an aortic repair device 2110 coupled to the coupler device 2130. The aortic repair device 2110 can include engagement (e.g., frictional) elements 2140, such as hooks, barbs, etc., on a leading portion 2195 of the aortic repair device 2110 of an external surface thereof that can engage an interior surface of the coupler device 21 0 to retain a position of the aortic repair device 2110 relative to the coupler device 2130. In some embodiments, the leading portion 2195 of the aortic repair device 2110 need not be oversized or as oversized as, for example, the aortic repair device 2010 shown in Figure 20, because the engagement elements 2140 act to secure the aortic repair device 2110 to the coupler device 2130. In some embodiments, the coupler device 2130 is spaced apart from the wall of the aorta.

[0095] Figure 22 is a side view of an aortic valve and aortic treatment system 2200 (“system”) positioned within an aorta in accordance with embodiments of the present technology. In the illustrated embodiment, the system includes a stent graft device 2210 coupled to a TAVR device 2220. The stent graft device 2210 can function as a coupler device (e.g., the coupler device 530 of Figures 5B and 6A-6C) and / or as an aortic repair device (e.g., the aortic repair device 510 of Figures 5A, 6B, and 6C). In the illustrated embodiment, the stent graft device 2210 includes a plurality of engagement (e.g., frictional) elements 2240, such as hooks,Attomey Docket No.: 144690.8OO6.WOOO185652453 1barbs, etc., on a leading end portion 2280 thereof. The engagement elements 2240 can engage a trailing portion 2285 of the TAVR device 2220 (e.g., a portion positioned superior to the aorta and spaced apart from the prosthetic leaflets of the TAVR device 520) to retain a position of the stent graft device 2210 relative to the TAVR device 2220.

[0096] Figure 23 A is a perspective side view of a coupler device 2300A positioned within an aorta and an aortic valve in accordance with embodiments of the present technology. In the illustrated embodiment, the coupler device 2300A includes a ring portion 2310 (e.g., a harness) configured to be positioned below the aortic valve in the left ventricle, a trailing portion 2390 of the coupler device 2300A comprising a stent graft 2320 configured to be positioned above the aortic valve, and a plurality of arms 2350 extending through the aortic valve and connecting the stent graft 2320 to the ring portion 2310. Accordingly, the coupler device 2300A defines a plurality of openings between the arms. The openings can be positioned such that the native aortic valve leaflets can at least partially move through the openings. In some embodiments, the coupler device 2300 A is for use with a TAVR device (not shown) intended to treat aortic insufficiency (e.g., aortic regurgitation). The TAVR device can be deployed within the coupler device 2300A and can capture the free edges of the native aortic leaflets through the openings in the coupler device 2300A. An aortic repair device (not shown) can be positioned within the trailing portion 2390 of the coupler device 2300A, and the coupler device 2300A can have one or more engagement (e.g., frictional) features 2340 to engage and secure the aortic repair device relative to the coupler device 2300A.

[0097] Figure 23B is a perspective side view of coupler device 2300B positioned within an aorta and an aortic valve in accordance with embodiments of the present technology. In the illustrated embodiment, the coupler device 2300B includes a ring portion 2310 (e.g., a harness) configured to be positioned below the aortic valve in the left ventricle, a trailing portion 2390 of the coupler device 2300B comprising a stent graft 2320 configured to be positioned above the aortic valve, and a narrowed central portion 2360 extending through the aortic valve and connecting the stent graft 2320 to the ring portion 2310. In some embodiments, the coupler device 2300B is for use with a TAVR device (not shown) intended to treat aortic stenosis. The TAVR device can be deployed within the narrowed central portion 2360 of the coupler device 2300B and expanded to engage and lock to the narrowed central portion 2360. An aortic repair device (not shown) can be positioned within the trailing portion 2390 of the coupler device 2300B and the coupler device 2300B can have one or more engagement (e.g., frictional) features 2340 to engage and secure the aortic repair device relative to the coupler device 2300B.Attomey Docket No.: 144690.8OO6.WOOO185652453 1

[0098] Figures 24A and 24B are side views of an aortic valve and aortic treatment system (“system) 2400 in a deployment position and a deployed position, respectively, within an aorta in accordance with embodiments of the present technology. Referring to Figures 24A and 24B, in the illustrated embodiment the system includes a coupler device 2430 and a TAVR device 2420. The coupler device 2430 can include an open wire harness 2410 at a leading end portion 2490 thereof with features that are configured to engage open diamonds in a mesh or stent structure 2450 of the TAVR device 2420, as shown in Figure 24B. The features of the open wire harness 2410 (e.g., hooks, projections, apices, etc.) can project / angle radially inward toward a longitudinal axis at the center of the coupler device 2430 to engage an exterior of the TAVR device 2420.

[0099] Referring to Figure 24A, in the deployment position the coupler device 2430 can be delivered from a delivery system 2460 including a plurality of pushers 2440 that drive the coupler device 2430 and harness 2410 forward and radially outward to overlap outside of the TAVR device 2420. The coupler device 2430 is shown partially opened in Figure 24A. Referring to Figures 24A and 24B, the pushers can be removed when the harness 2410 is positioned at a desired position relative to the TAVR device 2420. Referring to Figure 24B, when the pushers 2440 are removed and the coupler device 2430 is in the deployed position, the harness 2410 engages the trailing end portion 2485 of the TAVR device 2420 to stabilize and retain the coupler device 2430 relative to the TAVR device 2420. An aortic repair device (not shown) can be positioned within the trailing portion 2490 of the coupler device 2430 and the coupler device 2430 can have one or more engagement (e.g., frictional) features to engage and secure the aortic repair device relative to the coupler device 2430. In some aspects of the present technology, the coupler device 2430 of Figures 24A and 24B can engage a balloon-expandable TAVR device having a relatively short frame that does not extend very far superior to the aortic valve without interfering with the operation of the prosthetic leaflets of the TAVR device.

[0100] In some embodiments, an existing balloon-expandable TAVR device can be modified to have a longer frame to facilitate coupling to a coupler device and / or an aortic repair device. For example, a TAVR device in accordance with embodiments of the present technology can be similar to the type manufactured by Edwards Lifesciences under the trademark “SAPIEN 3” as shown in Figure 1A, but can have a longer stent frame. Accordingly, when the TAVR device is implanted at an aortic valve, the stent frame can extend farther superior relative to the aortic valve and relative to the prosthetic leaflets of the TAVR device to facilitate coupling (either radially inside or radially outside) of the TAVR device to a coupler device and / or anAttorney Docket No.: 144690.8OO6.WOOO185652453 1aortic repair device without inhibiting the function of the prosthetic leaflets. Likewise, in some embodiments an existing self-expandable TAVR device can be modified to have a longer frame to facilitate coupling to a coupler device and / or and aortic repair device. For example, a TAVR device in accordance with embodiments of the present technology can be similar to the type manufactured by JenaValve under the trademark “Triolgy” and / or the type manufactured by JC Medical under the trademark “J-Valve” as shown in Figure 1 A, but can have a longer stent frame.

[0101] Figures 25A and 25B are side views of an aortic valve and aortic treatment system (“system) in a deployment position and a deployed position, respectively, within an aorta in accordance with embodiments of the present technology. Referring to Figures 25A and 25B, in the illustrated embodiment the system includes a coupler device 2530 and a TAVR device 2520. The coupler device 2530 can include an open wire harness 2510 at a leading end portion 2580 thereof with features that are configured to engage open diamonds in a mesh or stent structure 2550 of the TAVR device 2520, as shown in Figure 25B. The features of the open wire harness 2510 (e.g., hooks, projections, apices, etc.) can project / angle radially outward away from a longitudinal axis of the coupler device 2530 to engage an interior of the TAVR device 2520.

[0102] Referring to Figure 25A, in the deployment position the coupler device 2530 can be delivered from a delivery system such that the harness 2510 is within an interior of the TAVR device 2520. Referring to Figure 25B, when the coupler device 2530 is in the deployed position, the harness 2510 engages a trailing end portion 2585 of the TAVR device 2520 to stabilize and retain the coupler device 2530 relative to the TAVR device 2520. An aortic repair device (not shown) can be positioned within the trailing portion 2590 of the coupler device 2530 and the coupler device 2530 can have one or more engagement (e.g., frictional) features 2540 to engage and secure the aortic repair device relative to the coupler device 2530. In some aspects of the present technology, the coupler device 2530 of Figures 25A and 25B can engage a selfexpandable TAVR device having a relatively long frame that extends superior to the aortic valve without interfering with the operation of the prosthetic leaflets of the TAVR device.

[0103] Although many of the embodiments described in detail above are described in the context of implanting aortic valve and aortic treatment systems within a native aorta and aortic valve of a patient, the present technology can also be deployed within previously-implanted medical devices (e.g., devices that are failing and / or limited due to the progression of a disease state). For example, a TAVR device in accordance with the present technology can be implanted within a native valve, a surgically-created or surgically-modified valve, a previously-placedAttorney Docket No.: 144690.8OO6.WOOO185652453 1TAVR device, and / or the like. Likewise, a coupler device and / or aortic repair device in accordance with the present technology can be implanted within a native aorta, a previously-placed surgical graft, an endovascular graft (e.g., stent graft), and / or the like.

[0104] Figure 26A is a perspective view of an aortic valve and aortic treatment system 2600 (“system 2600”) in accordance with embodiments of the present technology. Tn the illustrated embodiment, the system 2600 includes an aortic repair device 2610, a TAVR device 2620, and a coupler device 2630. Figures 26B-26D are perspective side views of the aortic repair device 2610, the coupler device 2630, and the TAVR device 2620, respectively, in accordance with embodiments of the present technology.

[0105] Referring to Figures 26A and 26B, the aortic repair device 2610 can be a stent graft having features generally similar or identical to the aortic repair device 510 of system 600. For example, the aortic repair device 2610 can be a stent graft comprising a plurality of stents coupled to a graft material and can include an internal septum dividing the aortic repair device into a first flow channel and a second flow channel.

[0106] Referring to Figures 26A and 26D, the TAVR device 2620 can be a selfexpandable, balloon-expandable, or mechanically-expandable device, such as any of the existing TAVR devices shown in Figure 1A. For example, in the illustrated embodiment the TAVR device 2620 is of the type manufactured by Edwards Lifesciences under the trademark “SAPIEN 3.” The TAVR device 2620 is configured to displace a native aortic valve and replace the function thereof.

[0107] Referring to Figures 26A and 26C, the coupler device 2630 can define a channel for routing blood therethrough. In the illustrated embodiment, the coupler device 2630 is at least partially tapered in a direction from a trailing (e.g., second, distal) end portion 2690 toward a leading (e.g., first, proximal) end portion 2680.

[0108] Figure 27 A is a perspective view of an aortic valve and aortic treatment system 2700 (“system 2700”) in accordance with embodiments of the present technology. In the illustrated embodiment, the system 2700 includes the aortic repair device 2610, the coupler device 2630, and a different TAVR device 2720 that can be, for example, of the type manufactured by Abbot Laboratories under the trademark “Navitor.” Figure 27B is a perspective side view of the TAVR device 2720.Attomey Docket No.: 144690.8OO6.WOOO185652453 1

[0109] Figures 28A-28C are side views of a first stage, a second stage, and a third stage, respectively, of a procedure to implant the system 2700 of Figure 27A in a patient in accordance with embodiments of the present technology. Referring to Figure 28A, in the first stage the coupler device 2630 can be implanted within the ascending aorta distal to the aortic valve. The aorta and the aortic valve can be diseased.

[0110] Referring to Figure 28B, in the second stage the aortic repair device 2610 can be implanted within the ascending aorta and coupled to the coupler device 2630. Referring to Figure 28C, in the third stage the TAVR device 2620 (or the TAVR device 2720, or a different TAVR device) can be implanted within the aortic valve and coupled to the coupler device 2630. The TAVR device 2620 can be delivered to and deployed within the aortic valve via a transcarotid approach, a transsubclavian approach, a transapical approach, and so on. In particular, the TAVR device 2620 can be delivered via a transfemoral approach.

[0111] Referring to Figures 28A-28C, in some embodiments, the coupler device 2630 and the aortic repair device are delivered via a transcarotid approach while the TAVR device 2620 is delivered via a transfemoral approach. In some aspects of the present technology, the different approaches allow for some or all of the components of the delivery systems used to deliver these components to be intravascularly positioned concurrently.

[0112] In yet other embodiments, the aortic repair device 2610 and the coupler device 2630 can be integrated into a single stent graft. Figure 29, for example, is a side view of an aortic valve and an aortic treatment system 2900 (“system 2900’’) implanted within a patient in accordance with embodiments of the present technology. Figure 29 shows an example of a stent graft 2910 that combines a coupler device (e.g., coupler device 2630 of Figure 26) and an aortic repair device (e.g., aortic repair device 2610 of Figure 26) into a single device.

[0113] Figures 3OA-3OE are perspective side views of different stages of a delivery system 3010 used to deploy an aortic repair device and / or a coupler device (collectively a “stent graft device 3020’’) within an aorta in accordance with embodiments of the present technology. The features and functions illustrated in Figures 30A-30E are described in further detail in U.S. Patent Application No. 18 / 784,740, titled “DELIVERY SYSTEMS FOR AORTIC ARCH REPAIR DEVICES, AND ASSOCIATED DEVICES AND METHODS,” filed July 25, 2024, which is incorporated by reference herein in its entirety and provide for precise orientation and placement control of the stent graft device to, for example, facilitate the delivery and coupling of the systems 600 and 2600 described in detail above.Attomey Docket No.: 144690.8OO6.WOOO185652453 1

[0114] Referring to Figure 30A, the delivery system 3010 can include one or more tip capture mechanisms for retaining leading and / or trailing end portions of the stent graft device 3020. The tip capture mechanisms can retain the stent graft device 3020 after unsheathing from a delivery catheter of the delivery system 3010 to provide for controlled, safe, and fine positioning of the stent graft device 3020 within the aorta. In some aspects of the present technology, this can enable the stent graft device 3020 to be precisely positioned relative to, for example, a previously-implanted TAVR device, coupler device, aortic repair device, etc., to facilitate overlap and coupling after deployment of the stent graft device 3020.

[0115] Referring to Figure 30B, the tip capture mechanisms can allow for staged release of, for example, the leading end portion of the stent graft device 3020. For example, a first side portion of the leading end portion (e.g., adjacent the interior wall of the aorta having a lesser curvature (e.g., a smaller radius of curvature, shorter length)) can be released before a second side portion of the leading end portion (e.g., adjacent an interior wall of the aorta having a greater curvature (e.g., greater radius of curvature, longer length)). Such controlled partial opening of the stent graft device 3020 can facilitate good alignment of the stent graft device 3020 with the wall of the aorta and / or with the interior of a previously -implanted TAVR device, coupler device, and / or aortic repair device.

[0116] Referring to Figure 30C, the delivery system 3010 can be driven forward after partial release of stent graft device 3020 from the leading tip capture mechanism to provide accurate tilt correction. For example, the second side portion of the leading end portion can be driven forward via its retention to the leading tip capture mechanism after the first side portion of the leading end portion is released (Figure 30B). In some aspects of the present technology, this can help facilitate squareness of the stent graft device 3020 after final release (Figure 30E). Specifically, driving the stent graft device 3020 forward can maximize overlap between the stent graft device 3020 and a previously-implanted TAVR device, coupler device, and / or aortic repair device.

[0117] Referring to Figure 30D, a trailing tip capture mechanism of the delivery system 3010 can be actuated to release a trailing end portion of the stent graft device 3020 in one or more stages to provide an open trailing end of the stent graft device 3020. In some aspects of the present technology, this enables an open path through the stent graft device 3020 (e.g., through the open trailing end and past the partially-opened leading end adjacent the released firstAttomey Docket No.: 144690.8OO6.WOOO185652453 1side portion of the leading end portion) while the delivery system 3010 still maintains the stent graft device 3020 in a stable position.

[0118] In some embodiments, a TAVR device (e.g., TAVR device 2620 of Figure 26) or coupler device device (e.g., coupler device 2630 of Figure 26) is delivered through the open path. For example, with the delivery system 3010 of the stent graft device 3020 inserted along a transcarotid approach, the delivery system 3010 for the TAVR device can be delivered through the open path along a transfemoral approach. Figure 31 A, for example, is a perspective side view of the delivery stage shown in Figure 30D and further including a TAVR delivery system 3110 inserted along the open path through the stent graft device 3020 in accordance with embodiments of the present technology.

[0119] Referring to Figure 30E, the leading tip capture mechanism can be further actuated to fully release the leading end portion (e.g., the second end portion of the leading end portion). In some aspects of the present technology, the staged release allows for accurate final positioning of the stent graft device 3020 with improved squareness within the aorta directly or within the interior of a previously-implanted TAVR device (e.g., TAVR device 2620 of Figure 26), coupler device (e.g., coupler device 2630 of Figure 26), and / or aortic repair device (e.g., aortic repair device 2610 of Figure 26).

[0120] In some embodiments, with a TAVR delivery system 3130 or coupler delivery system inserted along the open path through the stent graft device 3020, the delivery system 3110 can fully release the stent graft device 3020 before, during, or after the TAVR device 3020 or coupler device 2630. Figure 3 IB, for example, is a perspective side view of the delivery stage shown in Figure 30E (full release) and further including the TAVR delivery system 3110 inserted along the open path through the stent graft device 3020 in accordance with embodiments of the present technology. In the illustrated embodiment, the TAVR device 3120 is released after the stent graft device 3020 is fully released.III. Selected Embodiments of Functional Goals of Systems and Methods for Aortic Repair and Aortic Valve Replacement

[0121] Systems, devices, and methods described above and in accordance with the present technology can have different features, configurations, and / or the like depending on the functional treatment goal and disease state of a patient. For example, some systems can be configured to simply hold open the aorta lumen intermittently, others can be configured to prop it open continuously (with no space or gap between the TAVR device and the ascending aorticAttomey Docket No.: 144690.8OO6.WOOO185652453 1repair device), and yet others can be configured to provide a completely sealed lumen from the aortic annulus to near the brachiocephalic artery, with sealed lumens from that conduit feeding the coronary arteries.

[0122] For example, for TAVR patients with dilated ascending aortas, the goal of a system configured in accordance with the present technology can be to reduce or eliminate further dilation of the ascending aorta. In these cases, it may be sufficient to simply deploy an aortic repair device within the ascending aorta independent of the TAVR device. For example, the coupler device 530 can be omitted from the system 600 shown in Figure 6C and the TAVR device 520 and the aortic repair device 510 can be implanted with the aortic repair device 510 spaced apart from the TAVR device 520. In some such embodiments, the aortic repair device can be deployed more distal in the ascending aorta to avoid the TAVR device, rather than deploying the aortic repair device very proximal at the sinotubular junction.

[0123] For example, for patients with Type A dissections close to the sinotubular junction, the primary goal of a system configured in accordance with the present technology can be to maintain a widely patent true lumen in the ascending aorta. In these cases, it may be sufficient to simply deploy an aortic repair device close to the TAVR device. Overlapping the aortic repair device with the TAVR device may or may not be needed. For example, the coupler device 530 can be omitted from the system 600 shown in Figure 6C and the TAVR device 520 and the aortic repair device 510 can be implanted with the aortic repair device 510 (i) having its leading end positioned at or near the sinotubular junction and / or the aortic sinus but (ii) still spaced apart from the TAVR device 520. Ostial stents in the coronary arteries may or may not be needed.

[0124] For example, in patients with proximal Type A dissections, a goal of a system configured in accordance with the present technology can be to further seal off the dissection by providing a continuously sealed lumen. In these cases, the system can include a coupler device which extends down the outside of the TAVR device as, for example, described in detail with reference to Figures 6C, 25A, and 25B. It may be more difficult to place the coupler device inside the distal end of the TAVR device to seal the lumen at the distal aspect of the TAVR leaflets. The coupler device could extend to the aortic annulus, and can have a temporary trileaflet or bileaflet internal valve as, for example, described in detail with reference to Figures 8A-11C. In some embodiments, the coupler device can be deployed over and external to the TAVR device analogous to a “Cobra-mouth” deployment where the coupler device opens veryAttorney Docket No.: 144690.8OO6.WOOO185652453 1widely and then compresses down over the outside of the TAVR device (e.g., as shown in Figures 24A and 24B).

[0125] Further, a system in accordance with the present technology can provide for stable device implantation. For example, an aortic repair device of the system can be configured to deploy further into the sinus, such as with a row of diamonds or other features which splay out into the sinus (to the extent that the sinus is actually larger than the aorta) as, for example, described in detail with reference to Figure 17. Such splaying elements can be either open (e.g., bare) or covered with a graft material. Overlapping multiple devices (e.g., an aortic repair device, coupler device, and / or TAVR device) can provide more stability to some or all of the devices. In some embodiments, a dilated ascending aorta may not provide enough support for the distal elements of a long self-expanding TAVR device as illustrated in Figure IB and Figure 5C, and an aortic repair device in accordance with the present technology can help to provide that landing zone. Alternatively, having a coupler device which overlaps both the aortic repair device and the TAVR device can provide stability to the aortic repair device, or to both devices.

[0126] In some embodiments, a system in accordance with the present technology can include osteal stents for the coronary arteries. These could be standard coronary stents, deployed to extend right to the ostium of the coronary arteries, or even several millimeters into the sinus. They could also be osteal stents with significant flares at the ostia. Alternatively, they could be covered stents which extend from fenestrations 540 in a coupler device or aortic repair device into the coronary arteries with, for example, flared proximal ends to engage stably with the coupler device.IV. Selected Examples

[0127] The following examples are illustrative of several embodiments of the present technology:1. A coupler device configured to couple to a transcatheter aortic valve replacement (TAVR) device, the device comprising:a body having a first end portion and a second end portion, the body comprising:a graft material; anda plurality of stents coupled to the graft material, wherein —the graft material defines a channel extending through the body; andAttomey Docket No.: 144690.8OO6.WOOO185652453 1the first end portion is configured to be coupled to the TAVR device and the second end portion is configured to be coupled to an aortic repair device such that the channel defines a flow path for blood from the TAVR device, through the body, and to the aortic repair device.2. The coupler device of example 1, further comprising:a plurality of arms extending from the first end portion of the body, and wherein individual ones of the arms include:a first end coupled to the body; anda second end coupled to a ventricle pad.3. The coupler device of example 2 wherein the arms are bowed and asymmetrically positioned relative to the body.4. The coupler device of example 2 or example 3 wherein the ventricle pads have (a) a diamond-like pattern, (b) a material spanning at least part of their surface and configured to promote tissue ingrowth for biological migration resistance, and (c) wherein the ventricle pads are configured to engage an anterior surface within a ventricle.5. The coupler device of any one of examples 1-4, further comprising a valve positioned within the channel, wherein the valve includes a plurality of leaflets, and wherein individual ones of the leaflets include a flap of fabric and a reinforcement structure coupled to the flap of fabric, and wherein the plurality of leaflets are separated by at least one slit.6. The coupler device of example 5, further comprising:a release wire; andan elongate stabilization member configured to extend at least partially along the body and to stabilize the body, wherein the elongate stabilization member is configured to be releasably coupled to the release wire to secure a position of the elongate stabilization member relative to the body.Attorney Docket No.: 144690.8OO6.WOOO185652453 17. The coupler device of any one examples 1-6 wherein the body further comprises: a ring portion at the first end portion of the body and configured to be positioned below an aortic valve; anda narrowed central portion connecting the ring portion to the second end portion of the body.8. The coupler device of any one of examples 1-7 wherein the body further comprises an open wire harness at the first end portion of the body, and wherein the open wire harness includes one or more features configured to angle radially inward toward a center of the body of the coupler device to engage an exterior structure of a TAVR device.9. The coupler device of any one of examples 1-8 wherein the body further comprises a crown-like structure at the second end portion of the coupler device that is tapered, flared, or curled outward.10. The coupler device of any one of examples 1-9, further comprising a ring coupled to the first end portion of the coupler device, wherein the ring is configured to expand and reside below a sinotubular junction ridge at a top of an aortic sinus.11. The coupler device of any one of examples 1-10 wherein at least one of the plurality of stents is a fish-scale stent proximate to the first end portion of the body.12. A method of treating a diseased aorta and an aortic valve of a patient, the method comprising:intravascularly delivering a coupler device to a position within an ascending portion of the aorta;intravascularly delivering an aortic repair device to a position within the ascending portion of the aorta;coupling a leading end portion of the aortic repair device to a trailing end portion of the coupler device;intravascularly delivering a transaortic valve repair (TAVR) device to a position within the aortic valve; andAttorney Docket No.: 144690.8006.WO00185652453 1coupling a trailing end portion of the TAVR device to a leading end portion of the coupler such that the TAVR device, the coupler device, and the aortic repair device collectively provide a flow path for blood therethrough past the aortic valve and distally into the aorta.13. The method of example 12 wherein the coupler device comprises a stent graft.14. The method of example 13 wherein the aortic repair device comprises a stent graft.15. The method of any one of examples 12-14 wherein the method further compri ses positioning the leading end portion of the coupler device within an aortic sinus of the aorta.16. The method of any one of examples 12-15 wherein the method further comprises aligning a temporary valve of the coupler device with the aortic valve.17. The method of any one of examples 12-16 wherein the method further comprises aligning one or more fenestrations of the coupler device with one or more coronary arteries branching from the aorta.18. The method of any one of examples 12-17 wherein coupling the leading end portion of the aortic repair device to the trailing end portion of the coupler device comprises overlapping the leading end portion of the aortic repair device with the trailing end portion of the coupler device.19. The method of any one of examples 12-18 wherein coupling the trailing end portion of the TAVR device to the leading end portion of the coupler comprises overlapping the trailing end portion of the TAVR device with the leading end portion of the coupler device.20. A coupler device configured to couple to a transcatheter aortic valve replacement (TAVR) device, comprising:a body having a first end portion and a second end portion, the body comprising:a graft material defining a channel through the body; andAttorney Docket No.: 144690.8006.WO00185652453 1a plurality of stents coupled to the graft material;a plurality of arms extending from the first end portion of the body, wherein individual ones of the arms comprise:a first end coupled to the body; anda second end coupled to a ventricle pad; anda valve positioned within the channel, wherein the valve includes a plurality of leaflets, and wherein individual ones of the leaflets include a flap of fabric and a reinforcement structure coupled to the flap of fabric.IV. Conclusion

[0128] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments can perform steps in a different order. The various embodiments described herein can also be combined to provide further embodiments.

[0129] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms can also include the plural or singular term, respectively.

[0130] Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications can be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of theAttomey Docket No.: 144690.8OO6.WOOO185652453 1technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

Attorney Docket No.: 144690.8OO6.WOOO185652453 1CLAIMSI / W e claim:

1. A coupler device configured to couple to a transcatheter aortic valve replacement (TAVR) device, the device comprising:a body having a first end portion and a second end portion, the body comprising:a graft material: anda plurality of stents coupled to the graft material, wherein —the graft material defines a channel extending through the body; and the first end portion is configured to be coupled to the TAVR device and the second end portion is configured to be coupled to an aortic repair device such that the channel defines a flow path for blood from the TAVR device, through the body, and to the aortic repair device.

2. The coupler device of claim 1, further comprising:a plurality of arms extending from the first end portion of the body, and wherein individual ones of the arms include:a first end coupled to the body; anda second end coupled to a ventricle pad.

3. The coupler device of claim 2 wherein the arms are bowed and asymmetrically positioned relative to the body.

4. The coupler device of claim 2 wherein the ventricle pads have (a) a diamond-like pattern, (b) a material spanning at least part of their surface and configured to promote tissue ingrowth for biological migration resistance, and (c) wherein the ventricle pads are configured to engage an anterior surface within a ventricle.

5. The coupler device of claim 1, further comprising a valve positioned within the channel, wherein the valve includes a plurality of leaflets, and wherein individual ones of the leaflets include a flap of fabric and a reinforcement structure coupled to the flap of fabric, and wherein the plurality of leaflets are separated by at least one slit.Attomey Docket No.: 144690.8OO6.WOOO185652453 16. The coupler device of claim 5, further comprising:a release wire; andan elongate stabilization member configured to extend at least partially along the body and to stabilize the body, wherein the elongate stabilization member is configured to be releasably coupled to the release wire to secure a position of the elongate stabilization member relative to the body.

7. The coupler device of claim 1 wherein the body further comprises:a ring portion at the first end portion of the body and configured to be positioned below an aortic valve; anda narrowed central portion connecting the ring portion to the second end portion of the body.

8. The coupler device of claim 1 wherein the body further comprises an open wire harness at the first end portion of the body, and wherein the open wire harness includes one or more features configured to angle radially inward toward a center of the body of the coupler device to engage an exterior structure of a TAVR device.

9. The coupler device of claim 1 wherein the body further comprises a crown-like structure at the second end portion of the coupler device that is tapered, flared, or curled outward.

10. The coupler device of claim 1, further comprising a ring coupled to the first end portion of the coupler device, wherein the ring is configured to expand and reside below a sinotubular junction ridge at a top of an aortic sinus.

11. The coupler device of claim 1 wherein at least one of the plurality of stents is a fish-scale stent proximate to the first end portion of the body.

12. A method of treating a diseased aorta and an aortic valve of a patient, the method comprising:intravascularly delivering a coupler device to a position within an ascending portion of the aorta;Attorney Docket No.: 144690.8OO6.WOOO185652453 1intravascularly delivering an aortic repair device to a position within the ascending portion of the aorta;coupling a leading end portion of the aortic repair device to a trailing end portion of the coupler device;intravascularly delivering a transaortic valve repair (TAVR) device to a position within the aortic valve; andcoupling a trailing end portion of the TAVR device to a leading end portion of the coupler such that the TAVR device, the coupler device, and the aortic repair device collectively provide a flow path for blood therethrough past the aortic valve and distally into the aorta.

13. The method of claim 12 wherein the coupler device comprises a stent graft.

14. The method of claim 13 wherein the aortic repair device comprises a stent graft.

15. The method of claim 12 wherein the method further comprises positioning the leading end portion of the coupler device within an aortic sinus of the aorta.

16. The method of claim 12 wherein the method further comprises aligning a temporary valve of the coupler device with the aortic valve.

17. The method of claim 12 wherein the method further comprises aligning one or more fenestrations of the coupler device with one or more coronary arteries branching from the aorta.

18. The method of claim 12 wherein coupling the leading end portion of the aortic repair device to the trailing end portion of the coupler device comprises overlapping the leading end portion of the aortic repair device with the trailing end portion of the coupler device.

19. The method of claim 12 wherein coupling the trailing end portion of the TAVR device to the leading end portion of the coupler comprises overlapping the trailing end portion of the TAVR device with the leading end portion of the coupler device.Attorney Docket No.: 144690.8OO6.WOOO185652453 120. A coupler device configured to couple to a transcatheter aortic valve replacement (TAVR) device, comprising:a body having a first end portion and a second end portion, the body comprising:a graft material defining a channel through the body; anda plurality of stents coupled to the graft material;a plurality of arms extending from the first end portion of the body, wherein individual ones of the arms comprise:a first end coupled to the body; anda second end coupled to a ventricle pad; anda valve positioned within the channel, wherein the valve includes a plurality of leaflets, and wherein individual ones of the leaflets include a flap of fabric and a reinforcement structure coupled to the flap of fabric.

Images