Stent apparatus with support and methods for reducing unsupported arc length
The stent apparatus with integrated support structures addresses the issue of unsupported arc lengths in catheters and guidewires by providing mechanical support, enhancing deliverability and precision in navigating complex vascular anatomies.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- KELLY PATRICK W
- Filing Date
- 2026-01-21
- Publication Date
- 2026-07-30
AI Technical Summary
Conventional catheter and guidewire systems face challenges with unsupported arc lengths during endovascular procedures, leading to uncontrolled expansion, reduced pushability, and increased risk of vessel trauma due to acute vessel curvature and complex branch anatomy.
A stent apparatus with integrated support structures, such as cross-members, arch-shapes, and septums with bearing point openings, that act as mechanical supports for guidewires and catheters, reducing unsupported arc lengths and enhancing controlled deflection.
The support structures improve deliverability, stability, and precision of endovascular devices by minimizing arc lengths, reducing the risk of entrapment, and ensuring accurate navigation through complex vascular geometries.
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Abstract
Description
GrowIP No. KELL-23-001-WOSTENT APPARATUS WITH SUPPORT AND METHODS FOR REDUCING UNSUPPORTED ARC LENGTHCross-Reference to Related Applications
[0001] This international PCT application claims priority to U. S. Provisional Patent Application No. 63 / 747,740, filed on January 21, 2025, and to U. S. Provisional Application No. 63 / 792,895, filed on April 22, 2025, and the entireties of both applications are hereby incorporated by reference herein.Field
[0002] The present disclosure pertains to medical devices, specifically stent and / or stent graft apparatuses and systems designed to enable regulated delivery and advancement of guidewires, catheters, sheath systems, and / or other devices by reducing unsupported arc lengths during endovascular procedures.Background
[0003] Minimally invasive endovasculartechniques have become a mainstay for the treatment of aneurysmal and occlusive vascular disease, offering reduced morbidity and rapid recovery compared to open surgery. These approaches are advantageously performed percutaneously, typically through arterial access points, and rely on the introduction of medical devices that provide a sealed conduit to exclude aneurysmal sacs or reinforce diseased vessel segments while preserving patency of important branch vessels. However, endovascular navigation and deployment frequently involve acute vessel curvature and complex branch anatomy, which can challenge device deliverability and precise positioning, thereby increasing procedural difficulty and the potential for suboptimal outcomes.
[0004] Accordingly, certain catheter and guidewire systems have been developed to facilitate access to branch vessels via femoral or brachial approaches. These delivery systems incorporate deflectable tips that enable directional control, permitting the operator to traverse tortuous anatomy and engage branch conduits. However, as these delivery elements are advanced through a prosthesis (i.e., vascular graft material) or across branch openings, they tend to straighten or bow out, forming an unsupported arc with a radius that may exceed the mechanical limit of the device. As a result, uncontrolled expansion can compromise accuracy, reduce pushability, and increase the risk of vessel trauma or device instability.GrowIP No. KELL-23-001-WO
[0005] Improved apparatuses and methods are needed that avoid or reduce some of the problems associated with unsupported arc lengths in delivery elements associated with catheter and guidewire systems.Summary
[0006] In one aspect, a stent apparatus is provided that includes a stent having a main body with a first end, a second end, and at least one conduit extending between the first end and the second end. A support is arranged within the main body, the support having a first end and a second end, where the support is arranged as a cross-member such that the first end and the second end of the support are coupled to opposing sides of the main body. A bearing point opening is arranged between the support and the second end of the stent, the bearing point opening configured to permit ingress and egress of a transversing element, with the support acting as a bearing point during deployment.
[0007] In another aspect, a stent apparatus is provided that includes a stent having a main body, a first end, a second end, and at least one conduit extending between the first end and the second end. A support is coupled to the first end of the stent such that the support extends from the first end of the stent in a direction away from the second end of the stent, and the support has an arch-shape. A bearing point opening is arranged between the support and the first end of the stent, the bearing point opening configured to permit ingress and egress of a traversing element, with the support acting as a bearing point during deployment.
[0008] In another aspect, a stent apparatus is provided that includes a stent graft having a main body that has a primary conduit and a first bifurcation forming two secondary branches defining a first conduit and a second conduit. A support is arranged within the main body, the support having a first end and a second end, where the support is arranged as a cross-member such that the first end and the second end of the support are coupled to opposing sides of the main body above the first bifurcation, or where the support has an arch-shape such that the first end and the second end of the support are coupled to opposing ends of the first bifurcation. A bearing point opening is arranged between the support and the bifurcation, the bearing point opening configured to permit ingress and egress of a traversing element, with the support acting as a bearing point during deployment.
[0009] In another aspect, a stent apparatus is provided that includes a main body having a primary conduit, a support arranged within the main body, the support having a first end and a second end each coupled to the main body, and a bearing point opening arranged within the support and configured to permit ingress and egress of a traversing element, with the support acting as a bearing point during deployment.GrowIP No. KELL-23-001-WO
[0010] In another aspect, a stent apparatus is provided that includes a main body defining a primary conduit at a first end of the main body, a septum having a first end and a second end, the septum arranged within the main body to form two secondary branches defining a first conduit and a second conduit, where a first portion of the septum is uninterrupted and a second portion includes a bearing point opening, with the uninterrupted portion configured to act as a bearing wall for a traversing element during deployment, and a bifurcation within the first conduit forming two tertiary branches defining a third conduit and a fourth conduit in the main body, where the bifurcation is arranged opposite the septum from the primary conduit.
[0011] In another aspect, a stent apparatus is provided that includes a main body that defines a primary conduit, a septum arranged within and coupled to opposing sides of the main body to form two secondary branches defining a first conduit and a second conduit, and a bearing point opening arranged in the septum configured to permit ingress and egress of a traversing element, with a portion of the septum surrounding the bearing point opening acting as a bearing wall for the traversing element during deployment.
[0012] In another aspect, a stent apparatus is provided that includes stent having a main body defining a primary conduit having a length and a width, and a support member extending transversally across at least a portion of the width of the primary conduit, the support member including a surface substantially orthogonal to the length of the primary conduit to define a bearing point for a traversing element introduced in a first direction into the length of the primary conduit to reduce an unsupported arc length of the traversing element as the traversing element deflects in a second direction that ranges from 90 degrees to 180 degrees relative to the first direction.
[0013] In another aspect, a method for deployment of a stent apparatus is provided. The method includes advancing a guidewire via arterial access to a target location in a first artery, loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire, advancing the first sheath catheter along the guidewire to the target location, and deploying the stent apparatus into the first artery and / or a first conduit of a previously placed stent or stent graft at the target location. The method may further includes advancing the guidewire through the bearing point opening of the stent apparatus to cross from one conduit and back into the first artery or into a second conduit of the previously placed stent graft until the guidewire exits the main body of the stent and enters a second artery, loading a second sheath catheter containing a bridging stent or a therapeutic device onto the guidewire, advancing the second sheath catheter into a second artery, and deploying the therapeutic device or a distal end of the first bridging stent into the second artery and deploying a proximal end into the first artery or the second conduit of the previously placed stent. In some embodiments, the sheathGrowIP No. KELL-23-001-WOcatheter interacts with the support at a bearing point, thereby reducing the unsupported arc length of the sheath catheter by at least half.
[0014] In another aspect, a method for deployment of a stent apparatus is provided. The method includes advancing a guidewire, via arterial access, to a target location in an aorta, loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire, advancing the first sheath catheter along the guidewire to the target location, and deploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location. The method may further include advancing the guidewire through the bearing point opening between the support and the first bifurcation to cross from one conduit into another, loading a second sheath catheter containing a bridging stent onto the guidewire, advancing the second sheath catheter into a branch vessel, and deploying the bridging stent to connect the main body to the branch vessel. In some embodiments, the method includes redirecting the sheath catheter at the bearing point of the support and sealing the opening by deploying an additional stent apparatus or bridging stent.
[0015] In another aspect, a method for deployment of a stent apparatus is provided. The method includes advancing a guidewire, via arterial access, to a target location in an aorta, loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire, advancing the first sheath catheter along the guidewire to the target location, and deploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location. The method may further include advancing the guidewire to engage the support, redirecting the guidewire toward the second end of the main body until the guidewire exits the main body and enters a second artery, loading a second sheath catheter containing a bridging stent onto the guidewire, advancing the second sheath catheter into the second artery, and deploying the bridging stent to connect the main body or the aorta to the second artery.
[0016] In another aspect, a method for deployment of a stent apparatus is provided. The method includes advancing a guidewire, via arterial access, to a target location in an aorta, loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire, advancing the first sheath catheter along the guidewire to the target location, and deploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location. The method may further include advancing the guidewire through the bearing point opening in a septum to cross from a second conduit into a first conduit and then distally into a third conduit until the guidewire exits the main body and enters a branch artery, loading a second sheath catheter containing a bridging stent onto the guidewire, advancing the second sheath catheter into the branch artery, and deploying the bridging stent to connectGrowIP No. KELL-23-001-WOthe main body to the branch artery. In some embodiments, the sheath catheter interacts with the septum at the bearing wall and is redirected in a distal direction along the guidewire.
[0017] These, as well as other embodiments, aspects, advantages, and alternatives, will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings. Further, this summary and other descriptions and figures provided herein are intended to illustrate embodiments by way of example only and, as such, numerous variations are possible. For instance, structural elements and process steps can be rearranged, combined, distributed, eliminated, or otherwise changed, while remaining within the scope of the embodiments as claimed.Brief Description of the Drawings
[0018] The accompanying drawings are included to provide a further understanding of the systems, apparatus, devices, and / or methods of the disclosure, and are incorporated in and constitute a part of this specification. The drawings are not necessarily to scale, and sizes of various elements may be distorted for clarity and / or illustrated as simplistic representations to promote comprehension. The drawings illustrate one or more embodiments of the disclosure, and together with the description, serve to explain the principles and operation of the disclosure.
[0019] Figure 1 is a schematic diagram illustrating one embodiment of a patient-deployed stent apparatus with an integrated support structure acting as a bearing point for a sheath catheter and guidewire.
[0020] Figure 2A is a schematic diagram illustrating one embodiment of a stent apparatus with an integrated support structure configured to reduce unsupported arc lengths during deployment.
[0021] Figure 2B is a schematic diagram illustrating another embodiment of a stent apparatus with an integrated support structure configured to reduce unsupported arc lengths during deployment.
[0022] Figure 2C is a schematic diagram illustrating one embodiment of a stent apparatus with a support structure functioning as a bearing point for a sheath catheter and guidewire.
[0023] Figure 3A is a conceptual diagram illustrating a conventional sheath catheter having a relatively long unsupported arc length.GrowIP No. KELL-23-001-WO
[0024] Figure 3B is a conceptual diagram illustrating a sheath catheter benefitting from a reduced unsupported arc length in accordance with embodiments set forth herein.
[0025] Figure 4 is a schematic diagram illustrating several modular stent arrangements involving bridging stents and / or stent apparatus embodiments utilizing an integrated support structure configured to reduce unsupported arc lengths during deployment.
[0026] Figure 5A is a schematic diagram illustrating one embodiment of a stent apparatus with a primary conduit, secondary branches, tertiary branches, and an integrated support structure in the form of a septum with a bearing point opening acting as a cross member.
[0027] Figure 5B is a schematic diagram illustrating top and side views of a first embodiment of a stent apparatus with example dimensions.
[0028] Figure 5C is a schematic diagram illustrating a cross-sectional view of the embodiment of Figure 5B with example dimensions.
[0029] Figure 5D is a schematic diagram illustrating additional projection views of the embodiment of Figure 5B, including side, front, top, and bottom perspectives.
[0030] Figure 5E is a schematic diagram illustrating top and side views of a second embodiment of a stent apparatus with example dimensions.
[0031] Figure 5F is a schematic diagram illustrating a cross-sectional view of the embodiment of Figure 5E with example dimensions.
[0032] Figure 6A is a schematic diagram illustrating another embodiment of a stent apparatus, depicting the primary conduit, secondary branches, tertiary branches, quaternary branches, and an integrated support structure in the form of a septum with a bearing point opening acting as a cross member.
[0033] Figure 6B is a schematic diagram illustrating the embodiment of Figure 6A with example dimensions.
[0034] Figure 7A is a schematic diagram illustrating bridging stents in combination with one embodiment of a stent apparatus with a support member in the form of a septum with a bearing point opening acting as a cross member.
[0035] Figure 7B is a schematic diagram illustrating side, front, and top / bottom views of an embodiment of a conversion stent apparatus with a fenestration acting as a support structure for reducing unsupported arc lengths during deployment.GrowIP No. KELL-23-001-WO
[0036] Figure 7C is a schematic diagram illustrating the conversion stent apparatus of Figure 7B configured for integration with a native blood vessel or a previously placed stent or stent graft to facilitate vascular repair.
[0037] Figure 7D is a schematic diagram illustrating the conversion stent apparatus of Figure 7B deployed in a native blood vessel or a previously placed stent or stent graft and acting to reduce an unsupported arc length of a delivery catheter sheath.
[0038] Figure 7E is a schematic diagram illustrating projection views of another embodiment of a conversion stent apparatus having an integrated support structure in the form of a full-length septum with a centrally-located bearing point opening acting as a cross member.
[0039] Figure 7F is a schematic diagram illustrating projection views of yet another embodiment of a conversion stent apparatus having an integrated support structure in the form of a partial-length septum with a lower-located bearing point opening acting as a cross member.
[0040] Figure 7G is a schematic diagram illustrating projection views of two other embodiments of conversion stent apparatuses having integrated support structures in the form of partial-length septums with respective upper-located and centrally-located bearing point openings acting as cross members.
[0041] Figure 8A is a schematic diagram illustrating one embodiment of a stent apparatus with an internal arch-shaped support structure configured to reduce an unsupported arc length during deployment.
[0042] Figure 8B is a schematic diagram illustrating another embodiment of a stent apparatus with an internal arch-shaped support structure configured to reduce an unsupported arc length during deployment.
[0043] Figure 8C is a schematic diagram illustrating a guidewire and sheath catheter interfacing with the support structure utilizing the embodiment of Figure 8A to reduce an unsupported arc length.
[0044] Figure 8D is a schematic diagram illustrating a guidewire and sheath catheter interfacing with the support structure utilizing the embodiment of Figure 8B to reduce an unsupported arc length.
[0045] Figure 8E is a schematic diagram illustrating an internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure.GrowIP No. KELL-23-001-WO
[0046] Figure 8F is a schematic diagram illustrating another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure.
[0047] Figure 8G is a schematic diagram illustrating yet another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure.
[0048] Figure 8H is a schematic diagram illustrating another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure.
[0049] Figure 8I is a schematic diagram illustrating yet another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure.
[0050] Figure 8J is a schematic diagram illustrating another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure.
[0051] Figure 8K is a schematic diagram illustrating an external view of an embodiment of a stent apparatus with an internal arch-shaped support structure, depicting an arrangement of branches and conduits.
[0052] Figure 8L is a schematic diagram illustrating another external view of an embodiment of a stent apparatus with an internal arch-shaped support structure.
[0053] Figure 8M is a schematic diagram illustrating yet another external view of an embodiment of a stent apparatus with an internal arch-shaped support structure.
[0054] Figure 9A is a schematic diagram illustrating a previously placed stent graft prior to deployment of a stent apparatus with integrated support for reducing unsupported arc length during deployment.
[0055] Figure 9B is a schematic diagram illustrating a previously placed stent graft a stent apparatus intended for placement therein, the stent apparatus having an integrated external arch-shaped support structure for reducing unsupported arc length.
[0056] Figure 9C is a schematic diagram illustrating a previously placed stent graft with a deployed stent apparatus having an integrated external arch-shaped support structure for reducing unsupported arc length.
[0057] Figure 9D is a schematic diagram illustrating a guidewire and / or a sheath catheter interfacing with the external arch-shaped support structure of the deployed stent apparatus of Figure 9C to reduce an unsupported arc length.GrowIP No. KELL-23-001-WO
[0058] Figure 9E is a schematic diagram illustrating front, side, and top views of one embodiment of a conversion stent apparatus having an integrated external arch-shaped support structure.
[0059] Figure 9F is a schematic diagram illustrating the conversion stent apparatus of Figure 9E deployed in a native blood vessel and providing a reduced unsupported arc length to a catheter or sheath catheter interfacing with the external arch-shaped support structure.
[0060] Figure 10A is a schematic diagram illustrating an isometric view of one embodiment of a conversion stent apparatus with ante-grade and retrograde anchors.
[0061] Figure 10B is a schematic diagram illustrating a front view of one embodiment of a conversion stent apparatus with antegrade and retrograde anchors.
[0062] Figure 10C is a schematic diagram illustrating a side view of one embodiment of a conversion stent apparatus with antegrade and retrograde anchors.
[0063] Figure 10D is a schematic diagram illustrating a top / bottom view of one embodiment of a conversion stent apparatus with antegrade and retrograde anchors.
[0064] Figure 11A is a schematic diagram illustrating placement of a bridging stent via a stent apparatus in proximity to the celiac artery and superior mesenteric artery during an endovascular procedure, according to an example embodiment.
[0065] Figure 11B is a schematic diagram illustrating a system of vascular stent apparatuses deployed in vivo within a branching arterial system utilizing the stent apparatus, according to an example embodiment.
[0066] Figure 11C is a schematic diagram illustrating placement of bridging stents via stent apparatuses in relation to the celiac artery, superior mesenteric artery, and renal artery, according to an example embodiment.Detailed Description
[0067] The present detailed description provides illustrative embodiments of systems, apparatuses, and methods related to stent apparatuses and associated techniques for reducing unsupported arc lengths during endovascular procedures. The subject matter generally pertains to the field of medical devices, particularly stents, stent grafts, guidewires, catheters, sheaths, or other therapeutic devices used in minimally invasive vascular interventions. These devices and methods are designed to enhance deliverability, positioningGrowIP No. KELL-23-001-WOaccuracy, and procedural outcomes in complex anatomical environments, such as tortuous vessels or branch conduits.
[0068] Example systems, apparatus, devices, and / or methods are described herein. It should be understood that the word “example” is used to mean “serving as an example, instance, or illustration.” Any embodiment or feature described herein as being an “example” is not necessarily to be construed as preferred or advantageous over other embodiments or features unless stated as such. Thus, other embodiments can be utilized, and other changes can be made, without departing from the scope of the subject matter presented herein. The aspects described herein are not limited to specific embodiments, apparatus, or configurations, and as such can, of course, vary. It should be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only, and unless specifically defined herein, is not intended to be limiting.
[0069] Certain details, such as conventional materials, manufacturing techniques, or deployment methods, may be omitted where they are well-known to those skilled in the art. Furthermore, the subject matter includes various modifications, substitutions, and rearrangements of components or steps, provided they fall within the scope of the claims. The specific configurations and examples disclosed herein are illustrative and may be adapted or combined in numerous ways to suit particular applications or requirements.
[0070] Throughout this specification, unless the context requires otherwise, the words “comprise” and “include” and variations (e.g., “comprises,” “comprising,” “includes,” “including,” “has,” and “having”) will be understood to imply the inclusion of a stated component, feature, element, or step or group of components, features, elements, or steps, but not the exclusion of any other component, feature, element, or step or group of components, features, elements, or steps.
[0071] Further, unless context suggests otherwise, the features illustrated in each of the figures may be used in combination with one another. Thus, the figures should be generally viewed as component aspects of one or more overall embodiments, with the understanding that not all illustrated features are necessary for each embodiment.
[0072] As used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.GrowIP No. KELL-23-001-WO
[0073] Ranges can be expressed herein as from “about” one particular value and / or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint and independently of the other endpoint. As used herein, with respect to measurements, “about” means + / - 5 %.
[0074] As used herein, “proximal end” refers to the end of the main body stent graft that will be positioned closer to a patient’s heart than the “distal end” upon deployment. As used herein, “first end” and “second end” correspond to a proximal end and a distal end, respectively.
[0075] As used herein, “passive fixation” refers to friction, interaction between graft material of the stent grafts, radial strength of the metal frame of the stent structure, and blood pressure that holds stent grafts together at the site of overlap.
[0076] As used herein, “active fixation” refers to features coupled to a stent, graft, or stent graft that may actively engage native vessels or another stent graft, including hooks, bidirectional hooks, stent structure elements, anchors, staples, bio-activated adhesive, or a combination thereof, among other possibilities.
[0077] As used herein, a “stent graft” is a tubular, radially-expandable device that includes a fluid-tight (i.e., blood-tight) fabric supported by a stent and may be used to bridge diseased arteries. Any enumeration of elements, blocks, or steps in this specification or the claims is for purposes of clarity. Thus, such enumeration should not be interpreted to require or imply that these elements, blocks, or steps adhere to a particular arrangement or are carried out in a particular order.
[0078] Like numbers denote like features throughout unless otherwise specified.I. Overview
[0079] Minimally invasive endovascular procedures have become a cornerstone in the treatment of vascular diseases, such as aneurysms and occlusive conditions, due to their ability to reduce patient morbidity and recovery time compared to open surgical techniques. These procedures often involve navigating complex vascular anatomies, including acute vessel curvatures and intricate branch structures, using guidewires, catheters, sheaths, stents, stent grafts, and other therapeutic devices. However, conventional systems face significant challenges in maintaining precise device positioning and controlled delivery, particularly when traversing tortuous pathways or engaging branch vessels. A common issueGrowIP No. KELL-23-001-WOarises from the formation of unsupported arcs in directional sheath catheters or guidewires, for example, which can lead to uncontrolled expansion, reduced pushability or advancement, compromised accuracy, and increased risk of vessel trauma or device instability.
[0080] Existing stent graft designs utilizing anchoring “Z” stents extending from main body stent grafts. These Z peaks are intended to reinforce openings and provide structural support and are not contemplated to aid in guidewire and catheter advancement. This is because these anchor stents are designed to anchor in a native vessel or previously placed stent graft, and more notably the narrow apex or “Z” peaks exacerbate the problems noted above by introducing structural elements prone to device entrapment and adverse interactions with adjacent anatomy.
[0081] Specifically, Z peaks would present several disadvantages when used as bearing points for directional catheters. The acute angles (typically 30-60 degrees) create high-stress concentration points that can snag or catch catheter tips, impeding smooth passage. The abrupt transitions can cause device entrapment, where a catheter becomes wedged between the Z peak and the vessel wall, requiring forceful manipulation for release. Furthermore, the sharp geometry of Z peaks concentrates forces into small contact areas, increasing the risk of perforation or erosion of the graft material or catheter wall. In contrast, the support structures of the present disclosure are configured with gradual, low-profile geometries. Arch-shaped supports employ radii of curvature typically greater than 5 mm, and cross-member supports present smooth bearing surfaces substantially orthogonal to the catheter approach vector. These gradual configurations allow catheters to smoothly engage and deflect at the bearing point without catching or snagging. The larger contact area distributes forces over a wider region, reducing stress concentrations and minimizing material wear. Additionally, the support structures are positioned specifically to serve as bearing points for controlled catheter deflection, whereas Z peaks serve primarily as structural reinforcement with any attendant bearing functionality being incidental and often problematic. The smooth, gradual geometry of the present support structures reduces the risk of catheter or guidewire entrapment and facilitates predictable, controlled redirection during complex endovascular procedures.
[0082] The present disclosure addresses the problems above by introducing a stent apparatus with an integrated support structure designed to reduce unsupported arc lengths of guidewires, catheters, sheaths, or other therapeutic devices during deployment. The support, which may take the form of a cross-member, arch-shaped element, or septum with a bearing point opening, acts as a bearing point for directional sheath catheters and guidewires. This configuration enables controlled deflection of the traversing element, allowing the traversing element to navigate complex vessel geometries while maintaining stability and precision. ByGrowIP No. KELL-23-001-WOshortening the unsupported arc length, the support mitigates the risk of uncontrolled expansion and enhances the mechanical performance of the delivery system. Additionally, the support structure is designed with low-profile, gradual configurations to prevent device entrapment and adverse interactions, ensuring compatibility with native anatomy and adjacent devices. Radiopaque markers may be incorporated to facilitate precise positioning and orientation during imaging-guided procedures, further improving procedural accuracy.
[0083] This concept not only improves the deliverability and stability of stent graft systems but also enables advanced techniques, such as up-and-over maneuvers, for treating branch vessels via femoral or brachial access. The solution is adaptable to various stent and stent graft architectures, including single-conduit and multi-conduit designs, and can be deployed as a standalone stent or stent graft or as a component within a previously placed stent graft. By addressing the limitations of conventional systems, the described approach provides a robust and versatile platform for enhancing the safety, efficacy, and precision of endovascular interventions.II. Support Structure Configurations
[0084] The various support structure configurations (i.e., cross-member, internal arch, external arch, fenestrated septum) provide different advantages for specific anatomical and procedural requirements. Cross-member supports positioned as a septum with bearing point openings or a membrane with a fenestration (Figures 5A-7G) provide the advantage of spanning the full width of the main body, offering a large bearing surface and the ability to divide flow paths toward different branch territories. These are particularly advantageous for visceral applications where flow segregation between visceral and infrarenal territories is desired. Internal arch-shaped supports (Figures 8A-8M) provide a low-profile bearing point without dividing the flow path, making them suitable for single-target-vessel applications or when preservation of laminar flow is prioritized. The arch configuration self-positions centrally within the conduit and can be sized to various arch heights (typically 5-25 mm from the main body wall) to optimize the bearing point location. External arch-shaped supports (Figures 9A-9F) provide bearing point functionality while extending outside the primary flow path, minimizing any flow disturbance and providing the largest possible internal conduit diameter. These external configurations are particularly useful for conversion stent applications where the support must be added without significantly reducing the effective conduit. The selection among these configurations depends on factors including the target vessel anatomy, the required deflection angle (90° vs. 120° vs. 180°), the size of sheath catheters to be used, and whether the stent apparatus is deployed as a primary device or as a conversion device within existing stents.GrowIP No. KELL-23-001-WO
[0085] The disclosed methods leverage these structural advancements to enable regulated deployment of stent apparatuses, including stent grafts, and bridging stents via arterial access. For example, the methods include advancing a guidewire to a target location, loading a sheath catheter containing the stent apparatus onto the guidewire, and deploying the stent apparatus into a vessel or conduit. The support structure interacts with the sheath catheter or guidewire at a defined bearing point, reducing the unsupported arc length and allowing for controlled redirection of the device within the stent apparatus. Additional method steps may include advancing the guidewire through a bearing point opening to cross from one conduit to another, deploying bridging stents to connect the main body to branch vessels, and sealing openings by deploying additional stent apparatuses or bridging stents. These methods facilitate up-and-over maneuvers and complex branch access, improving procedural efficiency and safety. By integrating the support structure into both the apparatus and the deployment methods, the described approach provides a comprehensive solution for overcoming the limitations of conventional endovascular systems and techniques.
[0086] In general terms applicable across all embodiments disclosed herein, the stent apparatus includes a stent with a main body defining a primary conduit having a length and a width, with a support member extending transversally across at least a portion of the width of the primary conduit. The term "transversally" indicates that the support member extends in a direction that crosses the primary longitudinal axis of the primary conduit, which may include orientations that are perpendicular (90 degrees), oblique (at angles other than 90 degrees), or arcuate (following a curved path) relative to the length of the primary conduit. The support member includes a surface substantially orthogonal to the length of the primary conduit, meaning the surface is oriented generally perpendicular (within approximately 60-120 degrees of perpendicular) to the direction of flow or to the longitudinal axis of the conduit. This surface of the support member defines a bearing point for an element introduced in a first direction into the length of the primary conduit, wherein the bearing point reduces an unsupported arc length of the element as the element deflects in a second direction that ranges from 90 degrees to 180 degrees relative to the first direction. The “element” may be any elongate medical device including a guidewire, catheter, sheaths, stent, stent graft, or other therapeutic device that must navigate through the conduit and change direction to access branch vessels or downstream anatomy. In operation, the bearing point provides mechanical support during this directional change, effectively dividing what would be a single long unsupported arc into two or more shorter supported segments, each with improved mechanical stability.
[0087] The support member may take various structural forms while maintaining the fundamental bearing point functionality. In one broad category of embodiments, the supportGrowIP No. KELL-23-001-WOmember includes an elongate member in the form of a wire, a string, a cord, a rod, a filament, a fiber, and a strip. The elongate member extends across at least a portion of the width of the primary conduit, with the first end and second end of the elongate member coupled to the main body at opposing sides, at a bifurcation, or at other structural features of the stent apparatus. A portion of the elongate member, particularly the portion that spans across the conduit to interface with one or more elements (e.g., guidewires, catheters, sheaths, stents, stent grafts, and other therapeutic devices), serves as the surface that defines the bearing point. In some embodiments, the elongate member has a rounded cross section to prevent unintended interference with the element during advancement. The rounded cross section, which may be circular, elliptical, or oval, presents a smooth bearing surface without sharp edges that could snag or damage the element during advancement and retraction. Typical diameters or cross-sectional dimensions for the elongate member range from about 0.014 inches to about 0.050 inches (approximately 0.35 mm to 1.27 mm), selected to provide adequate mechanical strength while maintaining a low profile. The elongate member may extend at least partially outside the primary conduit and / or the main body when the stent apparatus is in a deployed condition, creating an external arch configuration as illustrated in Figures 9A-9F, or the elongate member may be entirely within the primary conduit and the main body when the stent apparatus is in a deployed condition, creating an internal arch or cross-member configuration as illustrated in Figures 8A-8M and Figures 2A-2C. In embodiments utilizing shape-memory materials such as nitinol, the elongate member is shape-memory biased to maintain a patency of the bearing point opening when the stent apparatus is in a deployed condition and to permit compression of the elongate member when the stent apparatus is in a delivery condition. This shape-memory bias allows the support member to be constrained within a delivery catheter during loading and advancement, and to self-expand to the predetermined configuration upon deployment, ensuring the bearing point is positioned as intended.
[0088] In another broad category of embodiments, the support member includes a membrane having a fenestration serving as a bearing point opening through which traversing elements pass. The membrane is arranged substantially coplanar with the length of the primary conduit, meaning the membrane extends along or parallel to the longitudinal axis of the conduit, effectively dividing the conduit into separate flow paths or chambers, as illustrated in the septum-based embodiments of Figures 5A-7G. A peripheral portion of the fenestration, which is the edge or border region surrounding the fenestration opening, serves as the surface that defines the bearing point. As a traversing element (e.g., a guidewire, a catheter, a sheath, or other therapeutic device) advances through the fenestration, the traversing element contacts this peripheral portion, particularly the upstream or proximal edge of the fenestration relativeGrowIP No. KELL-23-001-WOto the traversing element’s direction of travel, and this contact provides the bearing point interaction that reduces an unsupported arc length. The fenestration is sized large enough to accommodate the traversing element as the traversing element gradually deflects from the first direction toward the second direction, with fenestration dimensions typically ranging from about 3 mm to about 20 mm in width or diameter, and in some embodiments up to 30 mm or more for larger catheters or when multiple elements may pass through simultaneously. The sizing represents a balance between providing adequate passage space and maintaining sufficient membrane area surrounding the fenestration to serve as an effective bearing surface and to preserve structural integrity of the membrane. The septum or membrane will typically be formed from graft material and woven as part of a unitary structure, although other materials are contemplated.
[0089] In some embodiments of the membrane configuration, the membrane includes a flap gate over the fenestration, where the flap gate is hinged to close responsive to blood flow when the stent apparatus is deployed and expanded and when no traversing element is passing through the fenestration. The flap gate may include a thin membrane of graft material (e.g., ePTFE, polyurethane, or similar biocompatible material) attached along one edge of the fenestration with a living hinge or sutured hinge, configured to open when a traversing element is advanced through the fenestration (e.g., the advancing traversing element physically pushes the flap open) and to close when the traversing element is withdrawn or absent, with blood flow pressure causing the flap to seal against the fenestration opening. The flap gate thickness typically ranges from about 0.05 mm to about 0.3 mm, selected to provide sufficient flexibility for easy opening while maintaining adequate structural integrity for reliable closure. The hinge edge may be reinforced with sutures or adhesive to prevent tearing during repeated opening and closing cycles. This flap gate configuration enables temporary access through the fenestration during deployment procedures while providing a self-sealing mechanism that prevents blood flow through the fenestration during normal operation after the deployment is complete, eliminating potential Type III endoleak through this pathway without requiring additional sealing steps.
[0090] The membrane may include one or more peripheral reinforcements around at least a portion of the fenestration to enhance structural integrity, prevent tear propagation from the fenestration edge, and provide additional stiffness that improves bearing point functionality. The peripheral reinforcements may comprise various structures including suture oversewing (running or interrupted sutures placed around the fenestration circumference, typically 1-3 mm from the edge), adhesive or heat-sealed reinforcement bands (applying strips of adhesive or thermoplastic material around the fenestration to create a reinforced zone), or structuralGrowIP No. KELL-23-001-WOelements such as metal rings, polymer rings, or composite reinforcements that encircle the fenestration. In embodiments where the one or more peripheral reinforcements include at least one radiopaque marker, the marker serves the dual purpose of structural reinforcement and visualization enhancement. Radiopaque marker bands, typically formed from gold, platinum, or tantalum and having thickness of about 0.010 to 0.030 inches, may be affixed to the membrane around the fenestration periphery using sutures, adhesive, or mechanical crimping. These marker bands add structural rigidity that resists deformation of the fenestration under forces imparted by a traversing element, while simultaneously providing fluoroscopic visibility that permits identification of the fenestration location and orientation during deployment procedures. The operator can visualize the radiopaque markers under fluoroscopy to confirm the position of the fenestration relative to anatomical landmarks and target vessels, and can assess the orientation (rotational position) of the fenestration to ensure optimal alignment for the intended maneuvers by a traversing element.
[0091] The surface of the support member that defines the bearing point may have various geometric configurations optimized for smooth interaction with advancing traversing elements while providing effective mechanical support. In some embodiments, the surface has a flat portion to prevent unintended interference with the traversing element, presenting a planar bearing surface substantially perpendicular to the approach direction of the traversing element. The flat portion may extend across the full width of the conduit or may be limited to a central region where traversing element contact is expected, with the flat dimension (measured across the direction of traversing element travel) ranging from about 2 mm to about 15 mm. A flat bearing surface provides consistent contact area regardless of the exact path the traversing element takes through the bearing point opening and distributes forces uniformly across the contact region. In alternative embodiments, the surface has a gradually curved arched portion to prevent unintended interference with the traversing element, where “gradually curved” indicates that the radius of curvature is sufficiently large to avoid sharp transitions that could cause hang-up or snagging. The gradually curved portion has a radius of curvature larger than a radius of the traversing element (i.e., the outer radius of the catheter or guidewire), and preferably at least twice the radius of the traversing element, to ensure the traversing element can smoothly engage and slide along the curved surface without catching or abrupt deflection. For example, for a 10 French sheath catheter with outer diameter of approximately 3.3 mm (radius 1.65 mm), the bearing point surface would have a radius of curvature of at least 3.3 mm, and preferably at least 6-7 mm or more. The gradually curved configuration is particularly advantageous in arch-shaped support embodiments where the curve follows the natural deflection path of the traversing element, providing continuous support throughout the deflection arc rather than at a single point of contact. The smooth,GrowIP No. KELL-23-001-WOgradual geometry, whether flat or curved, allows the traversing element to engage the bearing point, deflect around or along the bearing surface, and continue into the second direction without hang-up, snagging, or abrupt transitions that could cause device entrapment or damage to the catheter, guidewire, or graft material.
[0092] The support member is configured to reduce the unsupported arc length of the traversing element by at least half compared to advancement without the support member, representing a key functional characteristic that unifies all embodiments of the invention. The unsupported arc length, as illustrated in the conceptual diagrams of Figures 3A-3B, is the distance over which an advancing traversing element must maintain its trajectory without external support, forming a curved path under its own stiffness and the forces applied during advancement. Without a bearing point (Figure 3A), this arc length may extend 40-60 mm or more, creating a large-radius curve that is mechanically unstable and prone to buckling, prolapse, or uncontrolled deflection when advancement forces are applied. The large radius results in low resistance to deformation, and the long unsupported span allows accumulation of elastic energy that can release suddenly, causing unpredictable catheter or guidewire behavior, for example. With the bearing point provided by the support member (Figure 3B), the arc is divided into segments, with at least one segment having a supported end at the bearing point. The reduction by at least half means that the maximum unsupported arc length is reduced from approximately 40-60 mm to approximately 15-30 mm, and in some embodiments even further to 10-20 mm depending on the specific geometry. This reduction provides the mechanical advantages of improved pushability (reduced force required to advance the element), enhanced directional control (reduced tendency for lateral deflection), reduced risk of device malposition (the element follows the intended path more reliably), and improved tactile feedback to the operator. The unsupported arc length reduction is achieved across all support member configurations disclosed herein, whether the support comprises an elongate member (e.g., a wire, a rod, a fiber, a strip), a membrane with fenestration (i.e., a septum with a bearing point opening), an arch-shaped structure, a cross-member, an internal configuration, an external configuration, or other geometries, as the bearing point interaction is the unifying functional characteristic.
[0093] The traversing element for which the unsupported arc length is reduced may be a guidewire, a catheter, a sheath, or other therapeutic devices that must navigate through the stent apparatus and deflect to reach target anatomy. Guidewires typically range from 0.014 inches to 0.038 inches in diameter (most commonly 0.035 inches for aortic and visceral applications), with lengths of 180-300 cm to accommodate the distance from the arterial access site through the stent apparatus to the target vessel. Catheters include diagnosticGrowIP No. KELL-23-001-WOcatheters (4-6 French), guide catheters (6-10 French), and balloon catheters (various sizes), each having different stiffness and deflection characteristics. Sheath systems, which are used to deliver stents and other devices, typically range from 8 French to 24 French for the applications described herein, with larger sizes used for aortic components and smaller sizes for branch vessel access. Each of these traversing element types experiences improved performance when navigating through the stent apparatus due to the reduced unsupported arc length provided by the bearing point of the support. The traversing element is typically introduced in a first direction generally aligned with the longitudinal axis of the primary conduit, meaning the traversing element enters the stent apparatus and initially travels in the direction of the conduit’s primary flow path. The traversing element must then deflect to a second direction ranging from 90 degrees (for perpendicular branching to side vessels) to 180 degrees (for reversal of direction in up-and-over maneuvers or retrograde access) relative to the first direction to reach the target vessel or anatomy. The support member bearing point facilitates this deflection by providing a mechanical support that the traversing element contacts during its directional change, converting a potentially unstable long-arc deflection into a controlled pivoting maneuver around a defined fulcrum point.
[0094] The disclosed stent apparatus and associated methods address the challenges of navigating complex vascular anatomies during endovascular procedures, particularly the formation of unsupported arcs in traversing elements (e.g., directional guidewires, catheters, sheaths or other therapeutic devices). These unsupported arcs can lead to uncontrolled expansion, reduced pushability, compromised accuracy, and increased risk of vessel trauma or device instability. The disclosed technology provides a solution by incorporating a support structure within or adjacent to the stent apparatus, which acts as a bearing point to reduce unsupported arc lengths and enable controlled deflection of traversing elements, such as guidewires, catheters, sheaths, or other delivery systems.
[0095] The stent apparatus is employed in minimally invasive vascular interventions, such as the treatment of aneurysms or occlusive vascular diseases, where precise positioning and stability are important. During deployment, the support structure interacts with the traversing element, redirecting the traversing element and reducing the radius of curvature by at least half. This configuration enhances deliverability and positioning accuracy, particularly in tortuous vessels or branch conduits. Representative performance results demonstrate improved procedural outcomes, including reduced vessel trauma and enhanced device stability. The stent apparatus is adaptable to various stent architectures, including singleconduit and multi-conduit designs, and can be deployed as a standalone stent or as a component within a previously placed stent graft. Embodiment configurations, such asGrowIP No. KELL-23-001-WOexternal or internal support arrangements, and alternative materials or geometries, also fall within the scope of the stent apparatus, ensuring compatibility with diverse anatomical and procedural requirements.III. Materials and Construction
[0096] The support structure may comprise various materials selected for biocompatibility, mechanical properties, and radiopacity. In arch-shaped embodiments, the support preferably comprises a nickel-titanium alloy (nitinol) wire having a diameter ranging from about 0.014 inches to about 0.035 inches, heat-treated to maintain the arch configuration with an austenite finish temperature below body temperature. In cross-member embodiments, the support may comprise a flat or curved strip of stainless steel, cobalt-chromium alloy, or nitinol, having a width ranging from about 2 mm to about 8 mm and a thickness ranging from about 0.1 mm to about 0.5 mm. In septum-based embodiments, the septum may include the same graft material as the main body described below (e.g., ePTFE, polyester fabric) or may include a thin-film polymer such as polyurethane with thickness ranging from about 0.05 mm to about 0.3 mm. The support structure may be coated with biocompatible coatings including heparin, phosphorylcholine, or other thromboresistant agents. The material selection ensures the support structure can withstand the forces imparted by catheter advancement (typically 1-5 Newtons) without significant deflection or deformation.
[0097] The stent apparatus may be manufactured using various techniques depending on the configuration. For embodiments with wire-based support structures, the wire is formed into the desired geometry using mandrels or dies, heat-treated to set the shape memory, and then mechanically coupled to the stent frame using welding (laser, resistance, or ultrasonic), adhesive bonding with biomedical adhesives such as cyanoacrylates or polyurethanes, or mechanical crimping. In one optional implementation, graft material may then applied over the assembled stent structure or integrated with an expandable metal frame, including a plurality of Z-stents, during a weaving process, with openings in the graft corresponding to the bearing point opening in the support structure. For septum-based embodiments, the septum may be created by: (1) sewing a running or interrupted suture line along the length of a tubular graft to divide the internal space; (2) heat-bonding or ultrasonically welding two layers of graft material together along a line; (3) applying adhesive to create a sealed barrier; (4) manufacturing a multi-conduit extrusion with integrated septum; (5) weaving a unitary multiconduit graft with an integrated septum. The bearing point opening in the septum is created by laser cutting, die cutting, or by incorporating a pre-formed opening during the seam creation process or the woven unitary process. Edges of the bearing point opening or fenestration may be finished with oversewing, heat-sealing, or application of radiopaque marker bands that alsoGrowIP No. KELL-23-001-WOserve to reinforce the opening and prevent propagation of tears during passage of the transversing elements.
[0098] A stent is typically a cylindrical frame and means any device or structure that adds rigidity, expansion force, or support to a prosthesis or native vasculature. A stent graft refers to an apparatus that includes a stent and a graft material associated therewith that forms a fluid-tight conduit through at least a portion of its length. “Fluid-tight” in reference to a stent graft refers to the ability of the apparatus to prevent blood (or other bodily fluids) from leaking through the walls of the graft, to permit blood to flow through the conduit of the stent graft rather than into an aneurysm sac, for example. This is achieved using an impermeable fabric covering, such as ePTFE or polyester (Dacron), over a metal stent structure. In various embodiments, the stent structure may be coiled, mesh, zig-zag or woven wires or a laser cut tube. A “graft” is a substantially cylindrical liner or a non-linear graft in a tapered configuration that may be disposed on the stent’s interior, exterior or both. In some embodiments, grafts may be woven as unitary structures with multiple lumens, as noted above. Further, when used in combination with a graft, the stent structure may include a series of spaced-apart Z-stent rings disposed along the length of the graft. A wide variety of attachment mechanisms are available to join the stent and graft together, including but not limited to, sutures, adhesive bonding, heat welding, and ultrasonic welding.
[0099] The stent can be made of any suitable material, including but not limited to biocompatible metals, implantable quality stainless steel wires, nickel and titanium alloys, and biocompatible plastics attached to a graft. Any suitable fluid tight or impermeable graft material can be used. In a one optional embodiment, the graft material is a biocompatible fabric, including but not limited to woven or knitted polyester, such as polyethylene terephthalate), polylactide, polyglycolide and copolymers thereof; fluorinated polymers, such as PTFE, expanded or electrospun PTFE and poly(vinylidene fluoride); polysiloxanes, including polydimethyl siloxane; and polyurethanes, including polyetherurethanes, polyurethane ureas, polyetherurethane ureas, polyurethanes containing carbonate linkages, woven nickel-titanium and polyurethanes containing siloxane segments. Materials that are not inherently biocompatible may be subjected to surface modifications in order to render the materials biocompatible. Examples of surface modifications include graft polymerization of biocompatible polymers from the material surface, coating of the surface with a crosslinked biocompatible polymer, chemical modification with biocompatible functional groups, and immobilization of a compatibilizing agent such as heparin or other substances. In embodiments where the support structure is a septum with a bearing point opening, the septum may be formed from the same graft material as the main body or from a distinctGrowIP No. KELL-23-001-WOmaterial selected for enhanced bearing surface properties. The graft material may be treated with surface modifications including covalent attachment of heparin or other anticoagulant agents to reduce thrombogenicity.
[0100] The support structure may be joined to the main body of the stent apparatus using various attachment mechanisms. For cross-member supports arranged between opposing sides of the main body, the first end and second end of the support may include extension arms configured to be coupled to a bifurcation or to opposing walls of the main body via sutures, adhesive bonding, heat welding, ultrasonic welding, or as part of a graft weaving process. In embodiments where the support includes a common graft covering technique, an uninterrupted continuous stent graft material extends from the main conduit over the extension arms of the support, providing a fluid-tight seal while maintaining the structural integrity of the bearing point. The attachment method is selected to ensure the support structure remains securely positioned during the dynamic forces encountered during deployment and operation, including pulsatile blood flow, advancement and retraction forces from the transversing element, and vessel movement. The attachment points where the support structure is coupled to the main body (such as extension arms illustrated in some embodiments) are reinforced areas where forces are transferred to the main body stent frame, typically using one or more of doubled graft material, adhesive, or direct metallic connection to the stent struts.
[0101] In all contemplated embodiments of the present disclosure, a stent graft may be used in place of a bare metal stent structure or frame. The terms septum and bearing point opening are used interchangeably with the terms membrane and fenestration, respectively, herein.IV. Stent Apparatus with Support and Methods for Reducing Unsupported Arc Length A. Reducing Unsupported Arc Lengths
[0102] Figure 1 is a schematic diagram illustrating one embodiment of a patient-deployed stent apparatus 100 with an integrated support structure 102 acting as a bearing point for a sheath catheter 106 and guidewire 104.
[0103] The stent apparatus 100 is configured for intravascular deployment within a vascular system 114 of a patient 116. The integrated support structure 102 is arranged within the stent apparatus 100 to provide a bearing and deflection point for delivery elements. The support structure 102 is positioned such that, during a procedure, a conventional guidewire 104 and sheath catheter 106 can be advanced through the stent apparatus 100 and interface with the support structure 102.GrowIP No. KELL-23-001-WO
[0104] The sheath catheter 106 and guidewire 104, which are standard tools in endovascular procedures, are shown traversing the stent apparatus 100. As the sheath catheter 106 is advanced in a first direction 108, the sheath catheter 106 engages the support structure 102, which acts as a bearing point to redirect the sheath catheter 106 into a second direction 110 toward a target location 112. This interaction reduces the unsupported arc length, described in further detail below, of the sheath catheter 106 and guidewire 104, thereby improving stability, control, and accuracy during navigation and deployment.
[0105] The arrangement of the support structure 102 within the stent apparatus 100 enables the sheath catheter 106 and guidewire 104 to perform up-and-over maneuvers and traverse complex branch anatomies with reduced risk of vessel trauma or device instability. This configuration provides a technical effect by facilitating precise and controlled delivery of conventional endovascular tools using the integrated support structure 102 of the stent apparatus 100.
[0106] In a general method applicable to various support structure configurations (including cross-member, arch-shaped, and septum-based embodiments), the stent apparatus is deployed to a target location within a first artery via arterial access, with subsequent bridging stent deployment facilitated by the integrated support structure. The method begins with advancing a guidewire via arterial access (such as femoral, brachial, or axillary artery access) to a target location in a first artery of a patient. The target location is selected based on the anatomical pathology being treated, such as an aneurysm requiring exclusion, and is typically positioned in a non-diseased segment of the artery proximal and / or distal to the pathology. The guidewire, typically 0.035 to 0.038 inches in diameter and 180-300 cm in length, is advanced under fluoroscopic guidance using standard catheter techniques. Once the guidewire is positioned at the target location, a first sheath catheter containing the stent apparatus is loaded onto a distal end of the guidewire. The stent apparatus is constrained within the first sheath catheter in a compressed, low-profile delivery configuration, with the support structure compressed to minimize the delivery profile. The first sheath catheter is advanced along the guidewire via the arterial access to the target location, with fluoroscopic confirmation of position using radiopaque markers on the stent apparatus and anatomical landmarks. The stent apparatus is then deployed into the first artery and / or a conduit of a previously placed stent or stent graft at the target location by retracting the sheath catheter while holding the stent apparatus in position, allowing the stent apparatus to self-expand and engage the arterial wall or the inner wall of the previously placed stent conduit.
[0107] Following deployment of the stent apparatus, the method continues with advancing the guidewire through the bearing point opening in the support structure, crossing from the at leastGrowIP No. KELL-23-001-WOone conduit of the stent apparatus and back into the first artery or into a second conduit of a previously-placed stent, until the guidewire exits the main body and enters a second artery or branch vessel. The guidewire path through the bearing point opening may involve an up-and-over maneuver where the guidewire initially advances in one direction through a conduit, engages the support structure, and is redirected through the bearing point opening to exit in a different direction aligned with the target second artery. The flexibility and torque response of the guidewire allow the operator to navigate the bearing point opening under fluoroscopic guidance. A second sheath catheter containing a first bridging stent is loaded onto the distal end of the guidewire while the guidewire spans from the arterial access point, through the stent apparatus and support structure bearing point opening, and into the second artery. The second sheath catheter is advanced along the guidewire, introduced into the second artery, and positioned to span the gap between the stent apparatus and the second artery. The first bridging stent is deployed by retracting the second sheath catheter, with the distal end of the first bridging stent expanding within the second artery and the proximal end expanding within the first artery or the conduit of the stent apparatus, thereby establishing a sealed connection that maintains blood flow to the second artery.
[0108] When the second sheath catheter is advanced through the bearing point opening in the support structure, the second sheath catheter interacts with the support structure at the bearing point, thereby reducing the unsupported arc length of the second sheath catheter by at least half compared to advancement without the bearing point. This interaction involves the outer surface of the second sheath catheter contacting the surface of the support structure that defines the bearing point, which may be an upper edge of a bearing point opening in a septum, an apex of an arch-shaped support, or a surface of a cross-member support. The contact occurs over a contact length of approximately 2-10 mm as the sheath catheter passes through the bearing point opening, and the support structure resists deflection under the catheter force (typically 1-5 Newtons), maintaining its position and providing a stable fulcrum for redirection. The reduction in unsupported arc length from approximately 40-50 mm to approximately 15-25 mm results in a dramatic improvement in catheter control, allowing the operator to maintain consistent forward progress without the sheath catheter bowing or deflecting unpredictably. The bearing point interaction is felt tactilely by the operator as increased resistance followed by sudden freedom of movement as the catheter tip passes beyond the bearing point, providing feedback that the critical deflection has been achieved. This method is applicable across all support structure configurations disclosed herein, with the specific geometry of the bearing point adapted to the particular support structure type while maintaining the fundamental unsupported arc length reduction benefit.GrowIP No. KELL-23-001-WO
[0109] Figure 2A is a schematic diagram illustrating one embodiment of a stent apparatus 200 with an integrated support structure 202 configured to reduce unsupported arc lengths during deployment. The stent apparatus 200 comprises a main body defining an internal conduit. The integrated support structure 202 is disposed within the main body in the illustrated embodiment and is configured to present a bearing point 206 for a sheath catheter 208 or other such device.
[0110] The support structure 202 is positioned along the longitudinal axis of the stent apparatus 200 to provide mechanical assistance during traversal of the sheath catheter 208. The bearing point 206 formed by a surface of the support structure 202 interacts with the sheath catheter 208 to redirect the trajectory of the sheath catheter 208, enabling navigation of complex vessel geometries while maintaining a reduced unsupported arc length. This configuration prevents excessive bowing or uncontrolled expansion of the sheath catheter 208, thereby avoiding procedural inaccuracies or vessel trauma.
[0111] The stent apparatus 200 further addresses the straightening force 204 that naturally arises as the sheath catheter 208 is advanced through the stent apparatus 200. The support structure 202 counteracts this force 204 by providing a stable bearing point 206, ensuring that the sheath catheter 208 follows the intended path and enhancing the precision and safety of the deployment process. This arrangement is particularly advantageous in endovascular procedures involving acute vessel curvatures or branch conduits, where precise positioning and controlled delivery are necessary.
[0112] The integration of the support structure 202 within the stent apparatus 200 provides a low-profile, gradual configuration that minimizes the risk of device entrapment or adverse interactions with adjacent anatomy. This design not only improves the mechanical performance of the stent apparatus 200 but also facilitates advanced techniques, such as up-and-over maneuvers, for accessing branch vessels via femoral or brachial approaches.
[0113] Figure 2B shows a schematic diagram illustrating another embodiment of a stent apparatus 220 with an integrated support structure 222 configured to reduce unsupported arc lengths during deployment. The support structure 222 is disposed within the main body and provides a bearing point 226 that interacts with a sheath catheter 228. As the sheath catheter 228 is advanced, the bearing point 226 redirects the sheath catheter 228, allowing the sheath catheter 228 to deflect in a second direction 224. This arrangement enables the sheath catheter 228 to traverse a reduced unsupported arc length, improving control and stability during navigation through the stent apparatus 220.GrowIP No. KELL-23-001-WO
[0114] Relative to the embodiment of Figure 2A, the configuration in Figure 2B illustrates a different arrangement of the support structure 222 and bearing point 226, which may be adapted for specific anatomical or procedural requirements. The support structure 222 is positioned to facilitate redirection of the sheath catheter 228 without introducing abrupt transitions or features that could interfere with device passage.
[0115] Figure 2C is a schematic diagram illustrating one embodiment of a stent apparatus 240 with a support structure 242 functioning as a bearing point for a sheath catheter 248 and guidewire 250. Figure 2C demonstrates a configuration where the support structure 242 is incorporated within the stent apparatus 240 to establish a defined bearing point 246. This arrangement is tailored to interact with a sheath catheter 248 and guidewire 250 during deployment, thereby reducing the unsupported arc length 244 and enhancing directional control.
[0116] The support structure 242 is positioned within the conduit of the stent apparatus 240 such that, during advancement, the sheath catheter 248 and guidewire 250 are redirected at the bearing point 246. This redirection enables controlled deflection and alignment, facilitating navigation through complex vessel geometries while minimizing the risk of uncontrolled expansion or device instability. The reduction in unsupported arc length 244, as shown in Figure 2C, is achieved by the mechanical resistance and guidance provided by the support structure 242, which distinguishes this embodiment from those shown in Figures 2A and 2B.
[0117] In some embodiments, the support structure 242 may include radiopaque markers to assist with imaging-guided placement and orientation. The low-profile, gradual configuration of the support structure 242 further ensures compatibility with native anatomy and adjacent devices. Figure 2C thus highlights the technical effect of integrating a support structure 242 within the stent apparatus 240 to enhance deliverability, procedural accuracy, and stability during endovascular interventions.
[0118] The stent apparatus embodiments illustrated in Figures 2A-2C represent a category of configurations where the support is arranged as a cross-member within the main body, with the support having a first end and a second end coupled to opposing sides of the main body. In this cross-member configuration, the support extends transversally across the internal space of the main body, spanning from one side of the circumferential wall to the opposite side. The opposing sides to which the first end and second end are coupled may be diametrically opposed (180 degrees apart around the circumference) or may be positioned at other opposing locations depending on the desired bearing point position and the anatomical orientation requirements. A bearing point opening is arranged between the support and theGrowIP No. KELL-23-001-WOsecond end of the stent, meaning the bearing point opening is positioned in the space bounded by the support structure on one side and the second end (distal end) of the stent apparatus on the other side. This bearing point opening is configured to permit ingress and egress of a traversing element, providing a passage through which these devices can enter and exit the stent apparatus during deployment procedures.
[0119] The stent in these embodiments includes an expandable metal structure or frame covered by a graft material, representing conventional stent graft construction adapted to incorporate the cross-member support. The expandable metal structure may be a selfexpanding framework of nitinol or stainless steel, laser-cut from tubing or formed from wire, that provides radial force to maintain patency and engage the vessel wall. The graft material, which may comprise ePTFE, polyester, or other biocompatible fabrics, covers the metal framework to create a fluid-tight barrier. The cross-member support may be integrated with the stent frame (formed as part of the same metal structure) or may be a separate component attached after stent fabrication. The support itself may be rounded, horseshoe-shaped, or squared-off in its cross-sectional profile. A rounded support, with circular or elliptical crosssection, provides smooth engagement with advancing catheters from any approach angle. A horseshoe-shaped support, with a U-shaped or C-shaped profile, may provide enhanced stiffness while maintaining a relatively low profile. A squared-off support, with rectangular or trapezoidal cross-section, may provide a flat bearing surface particularly suited for engagement with flat-sided delivery catheters or sheaths. The support may include a wire as the structural element, with a wire diameter typically ranging from 0.014 to 0.050 inches, selected to provide adequate mechanical resistance to deflection under catheter forces (1-5 Newtons) while minimizing the obstruction to flow.
[0120] In embodiments utilizing shape-memory materials, the support is shape-memory biased to maintain a patency of the opening in the support in a deployed condition and to permit compression of the support in a delivery condition. During delivery, the stent apparatus including the cross-member support is constrained within a delivery catheter, with the support compressed such that its span across the width of the main body is reduced. Upon deployment, as the constraining sheath is retracted, the support self-expands due to its shapememory properties, restoring the bearing point opening to its intended dimensions and positioning the bearing point for subsequent catheter interactions. The bearing point opening is configured to permit ingress and egress of a traversing element therethrough, where the support is configured to act as a bearing point acted upon by the traversing element during deployment of the traversing element. “Deployment” of the traversing element refers to advancement and / or retraction of a guidewire, catheter, sheath, or other therapeutic device.GrowIP No. KELL-23-001-WOThe support allows the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element when in contact with the support, enabling up-and-over maneuvers, acute angle branch access, and other complex navigational requirements. The support is configured to reduce an unsupported arc length of the traversing element by at least half, as described previously, providing enhanced mechanical performance during navigation.
[0121] To facilitate imaging-guided deployment and to assist operators in locating the support and opening, some embodiments further comprise at least one radiopaque marker coupled to the main body of the stent and arranged to permit identification of a location and / or an orientation of the support. The radiopaque marker may be positioned adjacent to the support structure, at the boundaries of the opening, or at other locations that indicate the support position. The marker material, such as gold, platinum, tantalum, or tungsten, appears clearly on fluoroscopic imaging, allowing the operator to visualize the support location relative to anatomical landmarks and to assess whether the opening is properly oriented for the intended catheter maneuvers. In some embodiments, the first end of the support and the second end of the support have respective extensions configured to be coupled to the main body of the stent or stent graft. These extensions, which may include flattened or flanged regions at the support ends, provide increased surface area for attachment via welding, suturing, or adhesive bonding, ensuring secure coupling that resists the forces encountered during advancement of the traversing element during deployment. The extensions distribute attachment forces over a larger area, reducing stress concentrations and improving long-term durability of the support-to-main-body connection.
[0122] Figures 3A and 3B are conceptual diagrams to illustrate the concept of reducing an unsupported arc length in an elongated member or traversing element, such as a sheath catheter.
[0123] FIG. 3A illustrates a sheath catheter 308 subjected to a straightening force 304 along an unsupported arc length 312. When there is no bearing point 306 or internal support, the sheath catheter 308 forms a long unsupported arc as the sheath catheter 308 moves through a conduit. This arrangement permits the sheath catheter 308 to bow or straighten to an excessive degree, potentially leading to diminished pushability, reduced accuracy, and a higher likelihood of device instability or vessel trauma.
[0124] The unsupported arc length 312 is not constrained by any internal support, such as a cross-member or arch-shaped element, and the sheath catheter 308 is unable to maintain a controlled curvature within the conduit. This is in direct contrast to FIG. 3B, where the presenceGrowIP No. KELL-23-001-WOof a support structure at the bearing point enables the sheath catheter to deflect in a controlled manner, thereby reducing the unsupported arc length and improving procedural outcomes. FIG. 3A thus highlights the limitations of systems lacking integrated support structures for traversing elements.
[0125] Figure 3B is a conceptual diagram illustrating a sheath catheter 328 benefiting from a reduced unsupported arc length 332 in accordance with embodiments set forth herein. Unlike Figure 3A, which depicts a sheath catheter with a relatively long unsupported arc length, Figure 3B demonstrates the technical effect of introducing a bearing point 326 along the curved pathway of the sheath catheter 328. The bearing point 326 provides mechanical support to the sheath catheter 328, thereby shortening the unsupported arc length 332 and enabling more controlled deflection as the catheter traverses a conduit, as described further below.
[0126] In example embodiments, the reduced unsupported arc length 332 achieved by the bearing point 326 results in improved stability, enhanced pushability, and decreased risk of vessel trauma during deployment. The reduced unsupported arc length configuration shown in Figure 3B, realized via the stent apparatus embodiments set forth herein, is particularly advantageous for navigating complex vessel geometries, such as acute curvatures or branch conduits, where precise positioning and controlled delivery are necessary. By comparison, the absence of a bearing point in Figure 3A leads to a free-standing curve that may compromise mechanical integrity and procedural accuracy.
[0127] In example embodiments set forth herein, the bearing point 326 may be implemented as part of a stent apparatus or support structure arranged within or adjacent to a conduit defined in the stent or a native blood vessel, providing a defined contact point for the sheath catheter 328 or other element and facilitating up-and-over maneuvers during endovascular procedures. The technical effect of this arrangement is a significant reduction in the unsupported arc length 332, which enhances the deliverability and safety of the sheath catheter system.
[0128] The bearing point provided by the support structure functions as a mechanical fulcrum that divides the unsupported arc of the traversing element into two shorter segments, each with a smaller radius of curvature and improved stability. In the absence of a bearing point, a catheter advanced through a conduit and required to deflect 90° to 180° to reach a branch vessel must form a single continuous arc with radius determined by the catheter stiffness and the available space. For typical catheters with bending stiffness in the range of 0.01 N·m² to 0.05 N·m² and available space of 30-50 mm, this unsupported arc may have a radius of 25-GrowIP No. KELL-23-001-WO40 mm, resulting in poor control and tendency to straighten under advancement forces. When the support structure provides a bearing point, the arc is divided into a proximal segment from the catheter entry point to the bearing point and a distal segment from the bearing point to the exit into the target vessel. Each segment has a radius approximately one-half that of the unsupported configuration, providing approximately four-fold increase in resistance to straightening (by the principle that deflection resistance varies inversely with radius squared). The bearing point may contact the catheter over an arc length of about 2 mm to about 10 mm, distributing the contact force to prevent damage to the catheter or graft material. The surface of the bearing point may be smooth and rounded to minimize friction and prevent hang-up or catching of the catheter during advancement.
[0129] The bearing point surface where the support structure interacts with the traversing element is configured to provide smooth deflection with minimal friction. The surface may be formed from or coated with low-friction materials including expanded PTFE, silicone, or hydrophilic polymer coatings such as polyvinylpyrrolidone (PVP) or poly(2-hydroxyethyl methacrylate) (PHEMA). The coefficient of friction at the bearing point preferably ranges from about 0.05 to about 0.2 to allow smooth catheter sliding while providing adequate tactile feedback to the operator. The bearing surface radius of curvature is preferably at least twice the outer diameter of the sheath catheter to be used, ensuring gradual deflection. For example, for a 10 French (3.3 mm outer diameter) sheath catheter, the bearing point radius of curvature is preferably at least 6-7 mm. The bearing point material must withstand repeated catheter passages during multi-branch procedures without significant wear or damage, typically requiring tensile strength of at least 20 MPa and tear resistance of at least 50 N / mm for the graft material in this region.
[0130] Figure 4 is a schematic diagram illustrating several modular stent arrangements 400 involving bridging stents 402, 404, 406, and 408 and / or stent apparatus embodiments 410, 412, and 414 utilizing an integrated support structure configured to reduce unsupported arc lengths during deployment, according to an example embodiment.
[0131] Each illustrated example stent apparatus includes an internal opening or fenestration 426, 428, or 430, having an upper surface / edge that serves as a bearing point for a traversing element, thereby reducing unsupported arc length during complex vascular interventions. As an alternative to the internal opening or fenestration 426, 428, or 430, one or more of the stent apparatuses could instead include a different type of support structure, such as an archshaped support attached to and above a bifurcation, for example, as described in further detail below. The illustrated example arrangement further includes an optional external fenestrationGrowIP No. KELL-23-001-WO424 and active fixation 432, which may be exposed or concealed, to provide secure anchoring within the vessel.
[0132] The connection pathways 416, 418, and 420 illustrate how the modular stent arrangements 400 can be tailored to specific anatomical requirements, enabling up-and-over maneuvers and branch vessel access. The bridging stents 402, 404, 406, and 408 facilitate the connection between stent apparatuses and native vessels or previously placed stent grafts, forming a continuous conduit for blood flow and to exclude an aneurysm or diseased tissue. Radiopaque markers may be included on the bridging stents or stent apparatuses to aid in precise positioning and orientation during imaging-guided procedures.
[0133] Figure 4 highlights the flexibility and scalability of the disclosed system, allowing for the creation of customized vascular repair constructs that address complex anatomical challenges and improve procedural outcomes.
[0134] Figure 5A shows a stent apparatus 500 including a stent graft 502 with a main body 504 that defines a primary conduit 506. Within the main body 504, a support cross member is provided in the form of a septum 508. The septum 508 is a thin membrane having a first end 510 and a second end 512 that divides the primary conduit 506 into two secondary branches: a first conduit 514 and a second conduit 516. The first conduit 514 further branches into a third conduit 518 and a fourth conduit 520. The septum 508 may be configured as a bifurcation or extension off of a bifurcation, for example. The septum 508 serves as an integrated support structure, with an uninterrupted portion (i.e., a peripheral edge or surface) of the septum acting as a bearing wall for a guidewire and / or sheath catheter passing through an interrupted portion (i.e., a fenestration, window, or opening) during deployment of the guidewire and / or sheath catheter. This configuration enables the redirection of the traversing element, reducing the unsupported arc length as the traversing element advances from one conduit to another.
[0135] The arrangement of the septum 508 and the branching conduits facilitates the ingress and egress of interventional devices or elements, supporting complex vascular procedures such as the placement of bridging stents, other stent apparatuses, and / or therapeutic devices. The structure of the stent apparatus 500 is designed to enhance device deliverability and stability within the vascular system, while maintaining patency and access to multiple branch vessels.
[0136] Figure 5B is a schematic diagram illustrating top and side views of a first embodiment of a stent apparatus 500 with example dimensions. The stent apparatus 500 includes a stent graft having a main body 504 defining a primary conduit 506, a septum 508 arranged withinGrowIP No. KELL-23-001-WOthe main body 504 and spanning the width of the main body 504 to divide the primary conduit 506 into secondary branches including a first conduit 514 and a second conduit 516, and an opening 534 in the septum 508 configured to permit ingress and egress of a traversing element. The septum 508 has a first end 510 and a second end 512 respectively coupled to opposing sides of the main body 504.
[0137] The stent apparatus 500 further includes a bifurcation of the first conduit 514 into a third conduit 518 and a fourth conduit 520. The diameters of the primary conduit 506, second conduit 516, third conduit 518, and fourth conduit 520 may be selected to accommodate various branch vessels and facilitate placement of bridging stents.
[0138] The top view 530 provides a schematic representation of the internal arrangement of the conduits 516, 518, 520 and the septum 508, while the side view 532 illustrates the spatial configuration and relative dimensions of the components. The bearing point opening 534 in the septum 508 acts as a bearing point during deployment, with an upper edge or surface of the bearing point opening 534 interfacing with and enabling controlled deflection of a traversing element and reducing unsupported arc length. This configuration enhances support for traversing elements, improving deliverability and positioning accuracy in complex vascular anatomies.
[0139] Figure 5C shows a cross-sectional view, taken along section A-A, of the embodiment of Figure 5B. The same reference numerals refer to the same components. The stent apparatus 500 includes the main body 504 defining the primary conduit 506, which serves as a central passage for blood flow or device traversal. According to the illustrated example of Figure 5C, the primary conduit 506 has an internal diameter ranging from about 10 mm to about 60 mm. Other dimensions could be used in alternative embodiments.
[0140] The septum 508 is arranged within and coupled at its first end 510 to the main body 504, forming a structural division and defining an opening 534 within the septum 508 (e.g., via opposing sides of the main body). Below the septum 508, the fourth conduit 520 is shown. The opening 534 has a diameter ranging from about 3 mm to about 20 mm, for example, and may be circular or polygonal, as shown in the example of Figure 5C. The bearing point opening 534 is a fenestration that is configured to permit ingress and egress of traversing elements, or other medical devices, and acts as a support member to enable controlled redirection of devices and to reduce the unsupported arc length of traversing elements. The arrangement of the septum 508 and the bearing point opening 534 provides a stable bearing point for traversing elements, supporting precision and minimizing the risk of vessel trauma during deployment.GrowIP No. KELL-23-001-WO
[0141] The cross-sectional view 536 demonstrates the internal configuration of the stent apparatus 500, showing the alignment of the primary conduit 506, the septum 508 with the bearing point opening 534 (with an alternative square opening shown in dashed line), and the fourth conduit 520 (and third conduit 518, which is not shown in Figure 5C). This integrated fenestration design within the main body 504 promotes versatile endovascular access while supporting structural integrity and procedural safety.
[0142] Figure 5D is a schematic diagram illustrating additional projection views of one embodiment of the stent apparatus 500, including side, front, top, and bottom perspectives. In one aspect, the stent apparatus 500 includes a main body 504 having a longitudinal axis and defining proximal and distal ends. A fenestration 534 is positioned internally within the main body 504, the fenestration 534 defining an bearing point opening that facilitates ingress and egress of traversing elements (e.g., guidewires, catheters, sheaths, and other therapeutic devices). The fenestration 534 is aligned with one or more conduits 506, 514, 516, 518, 520 formed within the main body 504, thereby ensuring smooth navigation and controlled deflection of traversing elements and minimizing unsupported arc lengths during endovascular procedures.
[0143] The side view 550 depicts the longitudinal arrangement of the fenestration 510 relative to the main body 504, where the fenestration 534 extends along the longitudinal axis to facilitate passage of traversing elements. The fenestration 534 (i.e., via an upper surface / edge thereof) serves as a bearing point for traversing elements and is positioned to enable precise alignment with branch conduits 506, 514, 516, 518, 520 for enhanced structural stability. The top view 554 reveals the spatial relationship between the fenestration 534 and the primary 506 and secondary conduits 514, 516, thereby facilitating unobstructed passage of medical devices and reducing the risk of device entrapment.
[0144] Figure 5E is a schematic diagram illustrating top and side views of a second embodiment of a stent apparatus 570 with example dimensions. Other dimensions may alternatively be used, in some embodiments. The stent apparatus 570 includes a stent 572 having a main body 574 that defines a primary conduit 576. A septum 578 or other supporting cross member is arranged within the main body 574, the septum 578 having a first end 580 and a second end 582 coupled to opposing sides of the main body 574. The septum 578 divides the primary conduit 576 into a first conduit 584 and a second conduit 586, the first conduit 584 and second conduit 586 being arranged orthogonally to facilitate directional control and access to branch vessels during deployment.GrowIP No. KELL-23-001-WO
[0145] The stent apparatus 570 further includes a third conduit 588 and a fourth conduit 590 branching from the first conduit 584. The third conduit 588 and fourth conduit 590 provide additional pathways for traversing elements, for example, to access smaller branch vessels in operation. In one embodiment, the primary conduit 576 has a diameter in the range from about 10 mm to about 60 mm; the first conduit 584 and second conduit 586 each have a diameter in the range from about 5 mm to about 40 mm; and the third conduit 588 and fourth conduit 590 each have a diameter in the range from about 3 mm to about 10 mm. Other dimensions may alternatively be used, in some embodiments. As used herein, diameter ranges of the conduits provided in the disclosure refer to an unconstrained and expanded state of the stent apparatus ex vivo prior to deployment. When the stent apparatus is in a constrained state for deployment in vivo the diameter ranges will be on the order of about 10-20% smaller in diameter.
[0146] The septum 578 or other support cross member serves as a bearing point for traversing elements, reducing the unsupported arc length of these devices and enabling controlled deflection and navigation through complex vascular pathways. The orthogonal arrangement of the first conduit 584 and second conduit 586 enhances access to branch vessels at varying angles, improving deliverability and stability of the stent apparatus 570 during endovascular procedures.
[0147] In certain embodiments, the stent apparatus 570 is configured for minimally invasive endovascular interventions, where precise positioning and stability are important for achieving favorable outcomes. The combination of the supporting cross member in the form of the septum 578 with a bearing point opening (not shown) and the orthogonal conduit architecture provides a solution for addressing the challenges associated with navigating complex vascular anatomies.
[0148] Figure 5F is a schematic diagram illustrating a cross-sectional view, taken along section B-B of Figure 5E, of one embodiment of the stent apparatus 570, with example dimensions. The stent apparatus 570 includes the main body 574 defining the primary conduit 576, the septum 578 arranged within the main body 574, and the opening 594 positioned centrally within the septum 578. The opening 594, which may be polygonal in shape, has a diameter in the range from about 3 mm to about 20 mm and is configured to permit ingress and egress of traversing elements. The uninterrupted portion of the septum 578 surrounding the opening 594 acts as a bearing wall during deployment, reducing unsupported arc length of directional sheath catheters or guidewires and enabling controlled deflection and navigation through complex vascular geometries.GrowIP No. KELL-23-001-WO
[0149] Below the septum 578, the stent apparatus 570 includes a bifurcation forming a third conduit 588 and a fourth conduit 590 representing a tertiary branch or additional pathway for device deployment. The third conduit 588 and the fourth conduit 590 may each have a diameter in the range from about 5 mm to about 20 mm, for example.
[0150] The arrangement of the support (i.e., septum 578) and the conduits (576, 584, 586, 588, 590) provides stability and compatibility with adjacent anatomical structures, minimizing the risk of device entrapment or adverse interactions. This cross-sectional configuration demonstrates the integration of the septum 578 and the bearing point opening 594 within the stent apparatus 570, facilitating advanced endovascular procedures such as up-and-over maneuvers and branch vessel access.
[0151] Figure 6A is a schematic diagram illustrating another embodiment of a stent apparatus 600, depicting the primary conduit 606, secondary branches 614, 616, tertiary branches 618, 620, quaternary branches 622, 624, and an integrated support structure in the form of a septum 608 with bearing point opening acting as a support cross member.
[0152] The stent apparatus 600 includes a stent 602 forming a main body 604 that defines the primary conduit 606. The septum 608 is arranged within the main body 604, dividing the primary conduit 606 into a first conduit 614 and a second conduit 616. The septum 608 has a first end 610 and a second end 612, each coupled to opposing sides of the main body 604, thereby providing a bearing point (i.e., at an upper surface / edge of the opening) for a guidewire or sheath catheter during deployment and reducing unsupported arc length.
[0153] The first conduit 614 bifurcates into a third conduit 618 and a fourth conduit 620, while the second conduit 616 bifurcates into a fifth conduit 622 and a sixth conduit 624. This arrangement of tertiary and quaternary branches enables the stent apparatus 600 to maintain patency and provide access to multiple branch vessels or anatomical regions by traversing elements such as a guidewire, catheter, sheath and / or therapeutic device, for example.
[0154] The septum 608 includes a fenestration (bearing point opening) that acts as a support cross member, allowing ingress and egress of a traversing member. The uninterrupted portion of the septum 608 surrounding the fenestration serves as a bearing wall, facilitating controlled deflection and precise positioning of medical devices. This configuration reduces the risk of device instability and vessel trauma during complex endovascular procedures.
[0155] In some embodiments, the stent apparatus 600 may include radiopaque markers to assist in identifying the location and orientation of the septum 608 and fenestration during imaging-guided placement. The structure is suitable for use in vascular interventions requiringGrowIP No. KELL-23-001-WOaccess to multiple branch vessels and can be combined with bridging stents or additional stent grafts to extend the therapeutic capabilities of the apparatus.
[0156] Figure 6B is a schematic diagram illustrating the embodiment of a stent apparatus 600 with example dimensions, according to an example embodiment. The stent apparatus 600 includes the main body 604 defining the primary conduit 606, with the septum 608 (or other supporting cross member) arranged within the main body to form two secondary branches: the first conduit 614 and the second conduit 616. The septum 608 extends from the first end 610 to the second end 612.
[0157] In one embodiment, the second conduit 616 bifurcates into two tertiary conduits, a third conduit 618 and a fourth conduit 620, while the first conduit 614 bifurcates into a fifth conduit 622 and a sixth conduit 624. These tertiary conduits are configured to accommodate traversing elements (e.g., guidewires, sheath catheters, or othertherapeutic devices), supporting precise navigation and deployment in complex vascular anatomies.
[0158] The dimensions of the stent apparatus 600 are specified to ensure compatibility with various anatomical structures and / or elements or devices. The diameter of the primary conduit 606 ranges from about 10 mm to about 60 mm, the diameters of the secondary conduits including the first conduit 614 and the second conduit 616 range from about 5 mm to about 40 mm, and the diameters of the tertiary conduits including the third conduit 618, fourth conduit 620, fifth conduit 622, and sixth conduit 624 range from about 3 mm to about 10 mm, for example. In one embodiment, the length of the second conduit 616 is in the range from about 0 cm to about 20 cm, and the lengths of the tertiary conduits, such as the fifth conduit 622 and the sixth conduit 624, are in the range from about 1 cm to about 5 cm. Other dimensions may be used in alternative embodiments.
[0159] The septum 608 acts as a bearing point for traversing elements such as directional sheath catheters and guidewires during deployment, reducing the unsupported arc length of these devices and enabling controlled deflection and navigation through tortuous vessel geometries. This arrangement is intended to improve procedural accuracy and safety in endovascular interventions.
[0160] Figure 7A is a schematic diagram illustrating bridging stents 702 in combination with one embodiment of a stent apparatus 700 with a support member in the form of a septum 708 with a fenestration 710 acting as a cross member.
[0161] The stent apparatus 700 comprises a main body 704 defining a primary conduit 706, which bifurcates into a first conduit 712 and a second conduit 714. The septum 708 spans theGrowIP No. KELL-23-001-WOwidth of the primary conduit 706 in the illustrated example, dividing the primary conduit 706 into the first conduit 712 and the second conduit 714. The fenestration 710 is positioned within the septum 708 and is configured to act as a bearing point for directional sheath catheters and guidewires.
[0162] The fenestration 710 is arranged to permit ingress and egress of traversing elements, enabling controlled deflection and reducing unsupported arc lengths during endovascular procedures. The fenestration 710 provides a stable bearing point, facilitating the redirection of the traversing elements as these components advance or retract through the stent apparatus 700, thereby minimizing the risk of uncontrolled expansion or vessel trauma.
[0163] The bridging stents 702 are shown configured to extend from the first conduit 712 and the second conduit 714 to branch vessels. The fenestration 710 serves as a guiding structure for the deployment of one or more of the bridging stents 702, ensuring accurate positioning and alignment within the vascular system.
[0164] Multiple views are provided in Figure 7A to illustrate the spatial arrangement and structural features of the stent apparatus 700. The front view 716 highlights the bifurcation of the primary conduit 706 by the septum 708. The side view 718 shows placement of the fenestration 710 within the septum 708 and the alignment of the fenestration 710 with the conduits 712 and 714, and the top / bottom view 722 demonstrates the cross-sectional arrangement of the primary conduit 706 and the secondary conduits 712 and 714.
[0165] In some embodiments, radiopaque markers may be incorporated into the septum 708 or fenestration 710 to facilitate identification and orientation during imaging-guided deployment. The markers may also serve to provide structural support around the fenestration 710.
[0166] Figure 7B is a schematic diagram illustrating side, front, and top / bottom views of an embodiment of a conversion stent apparatus 730 with a fenestration 742 acting as a support structure for reducing unsupported arc lengths during deployment. The conversion stent apparatus 730 may be deployed in and / or utilized in conjunction with a native blood vessel and / or a previously placed stent or stent graft, for example.
[0167] In one aspect, the conversion stent apparatus 730 includes a main body 738 defining a conduit 740 configured to facilitate passage of medical devices (i.e., traversing elements such as guidewires, sheath catheters, or other therapeutic devices). The fenestration 742 is integrated into the main body 738 and positioned within the conduit 740 to enable ingress andGrowIP No. KELL-23-001-WOegress of traversing elements during deployment, thereby reducing unsupported arc lengths and allowing for controlled deflection and navigation.
[0168] The side view 732 illustrates the profile of the main body 738 and the placement of the fenestration 742. The front view 734 provides a direct perspective of the fenestration 742, which is centrally aligned within the conduit 740. In one embodiment, the fenestration 742 serves as a bearing point for traversing elements, enabling controlled redirection of devices and minimizing the risk of uncontrolled expansion or device instability. The fenestration 742 may be reinforced with radiopaque markers to facilitate precise positioning and orientation during imaging-guided procedures. This configuration enhances the mechanical performance of the conversion stent apparatus 730 in complex anatomical environments, such as tortuous vessels or branch conduits, and supports advanced techniques for treating branch vessels and navigating challenging vascular geometries.
[0169] Figure 7C is a schematic diagram illustrating the conversion stent apparatus 730 configured for integration with a native blood vessel or previously placed stent or stent graft 750 to facilitate vascular repair, according to an example embodiment.
[0170] The fenestration 742 in the main body 738 of the conversion stent apparatus 730 (See Figure 7B) is arranged to serve as a bearing point for traversing elements, enabling controlled deflection and reducing unsupported arc lengths during endovascular procedures. The conversion stent apparatus 730 is configured to engage an inner surface of the native blood vessel or the previously placed stent or stent graft 750, allowing for secure placement and compatibility with adjacent anatomical structures. Radiopaque markers (not shown) may be included to facilitate identification of the location and orientation of the fenestration 742 (or other support member) during imaging-guided procedures.
[0171] In some embodiments, the conversion stent apparatus 730 supports up-and-over maneuvers for access to branch vessels via femoral approaches, for example, and may be implemented in single-conduit or multi-conduit stent architectures. The apparatus 730 may be deployed as a standalone device or as a component for use with or within a modular stent graft system, providing versatility for various vascular repair scenarios.
[0172] Figure 7D is a schematic diagram illustrating the conversion stent apparatus 730 installed in a previously placed stent or stent graft 750 and acting to reduce an unsupported arc length of an advancing delivery catheter 752, according to an example embodiment.
[0173] In one embodiment, the conversion stent apparatus 730 is positioned within the native blood vessel or previously placed stent or stent graft 750 to provide an internal supportGrowIP No. KELL-23-001-WOstructure for the delivery catheter 752 during endovascular procedures. The conversion stent apparatus 730 is configured to interact with the delivery sheath catheter 752 at a defined bearing point, corresponding to an upper surface / edge of the fenestration (See Figure 7B), thereby reducing the unsupported arc length of the catheter as the catheter traverses the vessel. This arrangement enables the delivery sheath catheter 752 to maintain a controlled curvature and facilitates precise navigation through complex vascular anatomy.
[0174] In a further embodiment, the conversion stent apparatus 730 may include a crossmember, an arch-shaped support, or a septum with an opening, each configured to act as a bearing point for the delivery catheter 752. The support structure of the conversion stent apparatus 730 allows the catheter to deflect in a controlled manner, minimizing the risk of uncontrolled expansion or bowing, and reducing the likelihood of vessel trauma or device instability.
[0175] In another embodiment, the conversion stent apparatus 730 may be equipped with one or more radiopaque markers to facilitate identification of the location and orientation of the support structure during imaging-guided procedures. The integration of the conversion stent apparatus 730 with the delivery sheath catheter 752 provides enhanced deliverability, stability, and positioning accuracy for medical devices introduced through the conduit of the vessel or stent.
[0176] Figure 7E is a schematic diagram illustrating projection views of another embodiment of a conversion stent apparatus 754 having an integrated support structure in the form of a full-length septum 764 with a centrally located fenestration 766 acting as a cross member. In one embodiment, the conversion stent apparatus 754 comprises a substantially cylindrical main body 754, with the septum 764 extending longitudinally within the main body 754 to divide the internal conduit into first and second regions. The centrally located fenestration 766 is formed in the septum 764 and is configured to permit ingress and egress of a traversing element. The fenestration 766 (i.e., via an upper surface / edge) serves as a bearing point for the traversing element, reducing the unsupported arc length of the traversing element and enabling precise redirection during endovascular procedures. The projection views include an isometric view 756, a side view 758, a front view 760, and a top / bottom view 762. The isometric view 756 highlights the overall cylindrical shape of the main body 754 and the internal arrangement of the septum 764. The side view 758 illustrates the longitudinal alignment of the septum 764 within the main body 754. The front view 760 shows the centrally located fenestration 766 on the septum 764. The top / bottom view 762 provides a cross-sectional perspective of the spatial arrangement of the septum 764 within the main body 754. The integration of the septum 764 and fenestration 766 into the conversion stent apparatus 754GrowIP No. KELL-23-001-WOprovides a low-profile, functional support structure that enhances deliverability and stability. This configuration minimizes the risk of device entrapment and adverse interactions with adjacent anatomical structures, promotes compatibility with native vessels and previously placed stent grafts, and facilitates advanced endovascular techniques by providing a dependable bearing point for directional sheath catheters and guidewires.
[0177] Figure 7F is a schematic diagram illustrating projection views of yet another embodiment of a conversion stent apparatus 768 having an integrated support structure in the form of a partial-length septum 776 with a lower-located fenestration 780 acting as a cross member.
[0178] The side view 770 depicts the partial-length septum 776 extending longitudinally within the conversion stent apparatus 768, with the first end 778 of the septum 776 positioned proximally. The septum 776 is configured to divide the primary conduit of the conversion stent apparatus 768 into two secondary branches, while the lower-located fenestration 780 is arranged to permit ingress and egress of a traversing element.
[0179] The front view 772 shows the spatial relationship between the septum 776 and the fenestration 780, with the uninterrupted portion of the septum 776 surrounding the fenestration 780 configured to act as a bearing wall for a traversing element during deployment. This arrangement enables controlled deflection of the traversing element and reduces the unsupported arc length within the conversion stent apparatus 768.
[0180] The top / bottom view 774 provides a cross-sectional perspective, further illustrating the central positioning of the fenestration 780 within the septum 776 and the overall configuration of the conversion stent apparatus 768. The septum 776 and fenestration 780 are arranged to maintain patency and facilitate the passage of medical devices, while the low-profile design of the septum 776 enhances compatibility with native anatomy and adjacent devices.
[0181] In various embodiments, the conversion stent apparatus 768 may include one or more radiopaque markers to facilitate identification of the location and orientation of the fenestration 780 during imaging-guided procedures. The integrated support structure formed by the septum 776 and fenestration 780 provides a bearing point for directional sheath catheters and guidewires, improving deliverability, positioning accuracy, and procedural outcomes in minimally invasive vascular interventions.
[0182] Figure 7G is a schematic diagram illustrating projection views of two other embodiments of conversion stent apparatuses 782, 794 having integrated support structuresGrowIP No. KELL-23-001-WOin the form of partial-length septums 788, 798 with respective upper-located and centrally located fenestrations 792, 799 acting as cross members.
[0183] In a first embodiment, the conversion stent apparatus 782 includes a main body defining a conduit, with a septum 788 extending partially along the longitudinal axis and terminating at a second end 790. The septum 788 incorporates a fenestration 792 positioned in an upper region, the fenestration 792 being configured to permit ingress and egress of a traversing element. The septum 788 surrounding the upper portion of the fenestration 792 acts as a bearing point, enabling controlled deflection of the traversing element and reducing unsupported arc length during deployment.
[0184] In a second embodiment, the conversion stent apparatus 794 comprises a main body defining a conduit, with a septum 798 arranged partially within the conduit and terminating at opposed ends. The septum 798 features a centrally located fenestration 799, which is dimensioned to allow passage of a guidewire or sheath catheter. The septum 798 surrounding the upper portion of the fenestration 799 provides a structural bearing point for the traversing element, facilitating precise navigation and stability during antegrade or retrograde deployment.
[0185] Both embodiments utilize the combination of septum 788, 798 and fenestration 792, 799 to provide a support structure that mitigates the risk of uncontrolled expansion and enhances the mechanical performance of the traversing elements. The fenestrations 792 and 799 are strategically positioned to allow interaction with the traversing elements, enabling advanced endovascular techniques in complex anatomical environments. The septum design in each embodiment maintains a low-profile configuration to prevent device entrapment or adverse interactions with adjacent anatomy, thereby improving procedural safety and accuracy.B. Method for Accessing Branch Vessels Through Septum-Based Support Structures
[0186] In embodiments where the stent apparatus comprises a septum-based support structure with an opening configured as a fenestration (such as illustrated in Figures 5A-7G), a method for sequential deployment of bridging stents enables access to multiple branch vessels while maintaining controlled navigation through the support structure. The method leverages the bearing wall functionality of the septum surrounding the opening to reduce unsupported arc lengths and facilitate directional control during each sequential access maneuver. The method is particularly advantageous for applications requiring access to vessels positioned on opposite sides of the stent apparatus or in different anatomical territories, such as when accessing visceral vessels from one conduit and intrarenal vesselsGrowIP No. KELL-23-001-WOfrom another conduit of the same stent apparatus. The sequential approach maintains blood flow through the stent apparatus throughout the procedure by keeping at least one conduit unobstructed at all times, avoiding the need for temporary occlusion or bypass.
[0187] Following deployment of the stent apparatus into the aorta or into a conduit of a previously placed stent or stent graft at the target location, a guidewire is advanced through the opening in the septum to cross from the second conduit into the first conduit of the main body. The guidewire, typically having a diameter of about 0.035 inches, is advanced from the arterial access point (e.g., femoral, brachial, or axillary approach) and introduced into the second conduit of the deployed stent apparatus. As the distal tip of the guidewire contacts the septum adjacent to the bearing point opening, the operator gently advances the guidewire while applying slight rotational or directional manipulation, causing the flexible tip to locate and enter the bearing point opening. The uninterrupted portion of the septum surrounding the bearing point opening serves as a guide surface, funneling the guidewire toward the bearing point opening and preventing the guidewire from advancing further within the second conduit. Once the guidewire passes through the bearing point opening and enters the first conduit, the guidewire is advanced distally through the first conduit, optionally through tertiary conduits if present, until the guidewire exits the main body at the second end of the stent apparatus. The guidewire then enters the aorta distal to the stent apparatus or enters a further target vessel such as a branch artery (e.g., celiac artery, superior mesenteric artery, or renal artery). Fluoroscopic guidance and radiopaque markers on the stent apparatus and guidewire enable the operator to visualize the guidewire path and confirm successful crossing through the septum’s bearing point opening.
[0188] After the guidewire has been advanced into the target vessel, a second sheath catheter containing a first bridging stent is loaded onto the distal end of the guidewire. The second sheath catheter, typically ranging from 6 French to 14 French in outer diameter depending on the bridging stent size, is advanced along the guidewire from the arterial access point, through the deployed stent apparatus, and toward the target vessel. As the second sheath catheter is advanced through the bearing point opening in the septum, the second sheath catheter interacts with the septum at the first end of the opening (the upper edge or surface when viewing the septum in its deployed orientation). This interaction creates a bearing wall effect where the edge of the septum acts as a fulcrum or deflection point. The sheath catheter, which initially approaches the septum in a generally proximal-to-distal direction through the second conduit, contacts the bearing wall and is redirected in a distal direction along the guidewire, effectively changing course by 90 to 180 degrees depending on the anatomical configuration. This redirection occurs with the septum bearing wall supporting the sheath catheter, therebyGrowIP No. KELL-23-001-WOreducing the unsupported arc length from what would be approximately 30-50 mm without the bearing wall to approximately 15-25 mm with the bearing wall support. The reduced unsupported arc length provides enhanced pushability and control, allowing the operator to advance the second sheath catheter into the target vessel with reduced risk of kinking, buckling, or loss of position. Once the distal end of the second sheath catheter is positioned in the target vessel with the proximal end remaining in the first conduit of the main body, the first bridging stent is deployed by retracting the sheath to allow the bridging stent to self-expand. The distal end of the first bridging stent expands within the target vessel (aorta or branch vessel), and the proximal end expands within the first conduit of the main body, creating a sealed conduit from the stent apparatus to the target vessel and preserving blood flow to that territory.
[0189] After deployment of the first bridging stent, the method may further include additional steps to access other vessels and to seal the opening in the septum. The guidewire is retracted from the target vessel where the first bridging stent was deployed, back through the first bridging stent, and into the first conduit of the main body of the stent apparatus. The guidewire is then further retracted through the opening in the septum, crossing back into the second conduit of the main body. This retraction is performed carefully to avoid dislodging the deployed first bridging stent, typically by maintaining the guidewire position within the bridging stent until a new guidewire path is established or by using a through-and-through technique with a second guidewire if needed. With the guidewire now positioned in the second conduit, the operator has access to the remaining flow path through the stent apparatus. This second conduit may lead to the infrarenal aorta, to a second branch vessel territory, or to another conduit system depending on the configuration of the stent apparatus. The ability to retract the guidewire and reposition it in the second conduit without removing it entirely from the stent apparatus provides procedural efficiency and maintains stable access to the device.
[0190] A third sheath catheter containing a second bridging stent or a second stent apparatus is loaded onto the distal end of the guidewire while the guidewire remains in the second conduit. The third sheath catheter is advanced along the guidewire, introduced into the second conduit of the main body, and positioned appropriately for deployment. The second bridging stent or second stent apparatus is then deployed such that the proximal end deploys into the second conduit of the main body and the distal end extends into the aorta or another target vessel. Importantly, this deployment serves a dual purpose: first, it establishes or maintains blood flow through the second conduit to the distal vasculature (such as the infrarenal aorta and iliac arteries); and second, it seals the opening in the septum of the first stent apparatus. The sealing occurs because the proximal end of the second bridging stent or second stentGrowIP No. KELL-23-001-WOapparatus, when expanded within the second conduit, covers the opening in the septum from the second conduit side, preventing any blood flow through the opening and eliminating potential Type III endoleak through this pathway. The overlap between the main body’s second conduit and the proximal end of the second bridging stent is typically at least 30 mm to ensure adequate passive fixation and seal. In some embodiments, the proximal end of the second bridging stent may include a flared or oversized segment specifically configured to engage and seal against the septum around the periphery of the opening. After this sealing deployment, the bearing point opening in the septum is effectively occluded, with the first bridging stent traversing the sealed space to maintain its connection between the first conduit and the target vessel, while the second bridging stent or stent apparatus provides the primary conduit for continued distal perfusion.
[0191] The sequential deployment method described above provides several technical advantages over alternative approaches. By accessing vessels sequentially through the same support structure opening rather than using multiple separate fenestrations, the method simplifies stent apparatus design and reduces the precision required for initial stent apparatus positioning, as exact alignment with specific branch vessel ostia is not required. The bearing wall interaction at the septum edge during each sheath catheter advancement provides consistent, predictable redirection with reduced unsupported arc length, improving success rates for catheter advancement into target vessels. The final sealing step eliminates the opening as a potential leak pathway while preserving the bridging connections previously established, resulting in a fully sealed repair with no endoleak through the device. This is in contrast to methods using permanent fenestrations that may require complex sealing procedures or that leave potential leak pathways. The method enables up-and-over maneuvers from femoral access or top-down approaches from brachial access, providing multiple options for achieving the desired vessel access. The ability to deploy multiple bridging stents through a single support structure bearing point opening reduces the total number of fenestrations or openings required in the stent apparatus, decreasing manufacturing complexity and improving overall structural integrity of the device.C. Extended Sequential Method for Multi-Vessel Visceral and Renal Debranching
[0192] In a comprehensive embodiment of the sequential deployment method applicable to complex thoracoabdominal aortic aneurysms requiring preservation of four or more branch vessels (such as celiac, superior mesenteric, and bilateral renal arteries), the method extends the principles described above to access multiple levels of branching vessels. This extended method is particularly applicable to stent apparatus configurations having a main body with a septum creating first and second conduits, with the first conduit further bifurcating into thirdGrowIP No. KELL-23-001-WOand fourth conduits for selective branch vessel access. The method begins with the foundational steps of advancing a guidewire via arterial access to a target location in the aorta, loading a first sheath catheter containing the stent apparatus onto the guidewire, advancing to the target location, and deploying the stent apparatus into the aorta or into a conduit of a previously-placed stent or stent graft. For visceral debranching applications, the target location is arranged super celiac, meaning the stent apparatus is positioned such that its distal end is superior to (upstream of) the celiac artery ostium, typically by 30-60 mm, allowing the third and fourth conduits to align with the celiac and superior mesenteric arteries.
[0193] The guidewire is then advanced through the bearing point opening in the septum, crossing from the second conduit into the first conduit of the main body, and then distally into the third conduit of the main body until the guidewire exits the main body and enters a super celiac artery, specifically the celiac artery in this example. The guidewire advancement through the bearing point opening involves the guidewire contacting the uninterrupted portion of the septum and being guided toward the bearing point opening by the septum surface. As described previously, the septum acts as a bearing wall during this navigation. The guidewire passes through the first conduit, which may have a length of 20-40 mm from the septum to the first bifurcation, and then selectively enters the third conduit based on rotational or directional manipulation by the operator. The third conduit, having a diameter typically ranging from 6-10 mm and a length of 20-40 mm, directs the guidewire toward the celiac artery ostium. A second sheath catheter containing a first bridging stent is loaded onto the distal end of the guidewire, advanced along the guidewire, and introduced into the super celiac artery. As the second sheath catheter is advanced through the bearing point opening in the septum, the second sheath catheter interacts with the uninterrupted portion of the septum (the bearing wall) and is redirected in a distal direction along the guidewire back toward the second end of the main body. This interaction reduces the unsupported arc length as previously described. The first bridging stent, typically 6-8 mm in diameter and 40-80 mm in length, is deployed with its distal end in the celiac artery and its proximal end in the third conduit, establishing celiac perfusion.
[0194] The method continues with sequential access to the superior mesenteric artery through the fourth conduit. The guidewire is retracted from the celiac artery back into the first conduit of the main body, carefully withdrawing through the deployed first bridging stent without disturbing its position. Once in the first conduit, the guidewire is redirected into the fourth conduit, which branches from the first conduit at the first bifurcation, typically oriented at an angle of 90-180 degrees from the third conduit. The guidewire is advanced through the fourth conduit until it exits the main body and enters the superior mesenteric artery. A thirdGrowIP No. KELL-23-001-WOsheath catheter containing a second bridging stent is loaded onto the distal end of the guidewire, advanced along the guidewire, introduced into the superior mesenteric artery, and the second bridging stent is deployed with distal end in the SMA and proximal end in the fourth conduit of the main body. At this point, both primary visceral vessels (i.e., celiac and SMA) have been revascularized through bridging stents deployed via the first conduit and its tertiary branches (third and fourth conduits), all accessed through the single opening in the septum with bearing wall support reducing unsupported arc lengths during each catheter advancement.
[0195] To seal the bearing point opening in the septum and to establish a platform for accessing renal arteries, the guidewire is retracted from the superior mesenteric artery back into the first conduit of the main body, then passed through the bearing point opening in the septum crossing back into the second conduit of the main body. A fourth sheath catheter containing a second stent apparatus is loaded onto the distal end of the guidewire, advanced along the guidewire, and introduced into the second conduit of the main body. The second stent apparatus is deployed such that a proximal end of the second stent apparatus is deployed into the second conduit of the main body, with sufficient overlap (typically 30-50 mm) to achieve passive fixation and seal. As the proximal end of the second stent apparatus expands within the second conduit, it covers the bearing point opening in the septum of the first stent apparatus, effectively sealing this bearing point opening from the second conduit side. The distal end of the second stent apparatus is deployed extending into the aorta distal to the first stent apparatus, providing a conduit for continued perfusion to the intrarenal aorta and enabling access to renal and iliac vessels. Importantly, the deployed first and second bridging stents to the celiac and SMA, which traverse the now-sealed space where the bearing point opening was located, remain in position and maintain their connections, as they pass through the region between the first conduit (now isolated on one side of the sealed septum) and their respective target vessels.
[0196] If the second stent apparatus is configured with its own support structure and bearing point opening (such as a second septum with fenestration or a second arch-shaped support with bearing point opening), the method may be further extended to access renal arteries through this second-level support structure. The guidewire is advanced through the bearing point opening in the septum of the main body of the second stent apparatus, crossing from the second conduit of the second stent apparatus into the first conduit of the second stent apparatus, then distally into the third conduit of the second stent apparatus until the guidewire exits the main body of the second stent apparatus and enters a branch artery such as the right renal artery. The guidewire path through the second stent apparatus mirrors the path throughGrowIP No. KELL-23-001-WOthe first stent apparatus, utilizing the bearing wall or bearing point of the second stent's support structure to facilitate navigation. A fifth sheath catheter containing a third bridging stent is loaded onto the distal end of the guidewire, advanced along the guidewire, introduced into the right renal artery, and the third bridging stent is deployed with distal end in the right renal artery and proximal end in the third conduit of the main body of the second stent apparatus. The typical bridging stent for renal arteries measures 5-7 mm in diameter and 40-60 mm in length. The guidewire is then retracted from the right renal artery back into the first conduit of the main body of the second stent apparatus, redirected into the fourth conduit of the second stent apparatus, advanced until exiting into the left renal artery, and a sixth sheath catheter containing a fourth bridging stent is loaded and advanced, deploying the fourth bridging stent with distal end in the left renal artery and proximal end in the fourth conduit of the main body of the second stent apparatus, completing bilateral renal revascularization.
[0197] Finally, to seal the bearing point opening in the second stent apparatus and to extend the repair to the iliac bifurcation, the guidewire is retracted from the left renal artery back into the first conduit of the main body of the second stent apparatus, passed through the bearing point opening in the septum and into the second conduit of the main body of the second stent apparatus. A seventh sheath catheter containing a fifth bridging stent is loaded onto the distal end of the guidewire, advanced along the guidewire, introduced into the second conduit of the main body of the second stent apparatus, and deployed such that a proximal end of the fifth bridging stent is deployed into the second conduit of the main body, covering and sealing the bearing point opening in the septum of the second stent apparatus. The distal end of the fifth bridging stent is deployed extending into the aorta to receive additional bridging stents for extension into right and left iliac arteries, thereby excluding the aneurysm and completing a comprehensive endovascular repair extending from the super celiac aorta to the iliac bifurcation with preservation of celiac, superior mesenteric, and bilateral renal artery perfusion. This extended sequential method demonstrates the capability of the stent apparatus with integrated support structure to serve as a building block in complex multi-component repairs, with each support structure enabling controlled access to the next level of branch vessels through bearing point interaction that consistently reduces unsupported arc lengths and improves procedural success.
[0198] Figure 8A is a schematic diagram illustrating one embodiment of a stent apparatus 800 with an internal arch-shaped support structure 804 configured to reduce an unsupported arc length during deployment, according to an example embodiment.
[0199] The stent apparatus 800 includes a main body 802 defining a primary conduit 808 that extends between a first proximal end (upper portion, as illustrated) and a second distal endGrowIP No. KELL-23-001-WO(lower portion, as illustrated). An internal support structure 804 is arranged within the main body 802 and spans transversally across at least a portion of the primary conduit 808. The support structure 804 is arch-shaped and provides a low-profile bearing point for traversing elements. A bearing point opening 806 is defined between the support structure 804 and the second distal end of the main body 802, allowing ingress and egress of medical devices such as traversing elements. The support structure 804 interacts with said devices during deployment to enable controlled deflection and to reduce the unsupported arc length by at least one-half, thereby mitigating the risk of uncontrolled expansion and enhancing device stability and precision during navigation through complex vascular geometries.
[0200] In one embodiment, the main body 802 transitions below the support structure 804 into a first bifurcation 810, dividing the primary conduit 808 into a first conduit 812 and a second conduit 814. In a further embodiment, a second bifurcation 816 further forms a third conduit 818 and a fourth conduit 820 from the first conduit 812, thereby providing additional pathways for accessing smaller branch vessels and enabling complex endovascular procedures such as the placement of bridging stents. The branching architecture facilitates the redirection of medical devices into branch vessels with high accuracy.
[0201] In another embodiment, radiopaque markers may be incorporated into the support structure 804 and / or the main body 802 to facilitate precise positioning and orientation during imaging-guided procedures. The bearing point opening 806 may be configured to permit passage of guidewires and sheath catheters having diameters in the range from about 0.035" to about 0.050", for example, and the arch-shaped support structure 804 may be dimensioned to engage such devices. This design accommodates a wide array of anatomical configurations and procedural requirements while maintaining a low delivery profile.
[0202] Figure 8B is a schematic diagram illustrating another embodiment of a stent apparatus 830 with an internal arch-shaped support structure 834 configured to reduce an unsupported arc length during deployment. The stent apparatus 830 includes a main body 832 defining a primary conduit 838, with the internal support structure 834 arranged within the main body 832 and spanning at least a portion of the width of the primary conduit 838. The support structure 834 includes a bearing point opening 836 configured to permit ingress and egress of a traversing element, with the support structure 834 acting as a bearing point for such devices to enable controlled deflection and reduce unsupported arc lengths during deployment.
[0203] The main body 832 further comprises a first bifurcation 840 that divides the primary conduit 838 into a first conduit 842 and a second conduit 844, each configured to provide access to branch vessels or other anatomical structures. A second bifurcation 846 isGrowIP No. KELL-23-001-WOpositioned distal to and / or adjacent to the first bifurcation 840, further dividing the first conduit 842 into a third conduit 848 and a fourth conduit 850. This multi-conduit configuration accommodates complex vascular anatomies and facilitates treatment of branch vessels.
[0204] In one embodiment, the bearing point opening 836 of the support structure 834 is sized and shaped to permit passage of traversing elements while maintaining sufficient metal coverage of the primary conduit 838 for structural stability. The arrangement of the support structure 834 and the multi-conduit design enhances device navigation, particularly in tortuous or branched vessel geometries.
[0205] In another embodiment, the second bifurcation 846 and the tertiary conduits 848, 850 provide additional pathways for accessing downstream branch vessels, supporting advanced endovascular techniques and facilitating deployment of bridging stents to connect the main body 832 to branch vessels. The combination of the support structure 834 with the multiconduit configuration mitigates the risk of device entrapment or adverse interactions and ensures compatibility with native anatomy and adjacent devices.
[0206] The stent apparatus 830 is adaptable to various clinical applications, including the treatment of aneurysms and occlusive vascular conditions. By incorporating the support structure 834 and the multi-conduit configuration, the stent apparatus 830 provides a solution for improving the safety, efficacy, and precision of endovascular interventions.
[0207] Figure 8C is a schematic diagram illustrating a deployed guidewire 860 and sheath catheter 862 utilizing a stent apparatus 800 with an internal arch-shaped support structure 804 configured to reduce an unsupported arc length during deployment, according to an example embodiment.
[0208] The stent apparatus 800 includes a primary conduit 808 extending between a proximal end and a distal end, a first bifurcation 810 forming a fourth conduit 820, and an internal support structure 804 arranged within the primary conduit 808 proximal to the first bifurcation 810. An opening 806 is defined between the support structure 804 and the first bifurcation 810, permitting ingress and egress of the guidewire 860 and sheath catheter 862.
[0209] The support structure 804 acts as a bearing point for the guidewire 860 and sheath catheter 862, facilitating controlled deflection from the primary conduit 808 through the opening 806 into the fourth conduit 820. The guidewire 860 and sheath catheter 862 could be similarly advanced through the third conduit. This arrangement reduces the unsupported arc length of the sheath catheter 862, enhancing stability and pushability during advancement and minimizing the risk of uncontrolled expansion or vessel trauma.GrowIP No. KELL-23-001-WO
[0210] In certain embodiments, the opening 806 is sized to accommodate the guidewire 860 and sheath catheter 862 while maintaining the structural integrity of the stent apparatus 800. The configuration of the support structure 804 and opening 806 enables precise navigation through complex vascular anatomies, supporting advanced endovascular techniques and improving procedural accuracy.
[0211] Figure 8D is a schematic diagram illustrating a deployed guidewire 860 and sheath catheter 862 utilizing a stent apparatus 830 with an internal arch-shaped support structure 834 configured to reduce an unsupported arc length during deployment, according to an example embodiment.
[0212] The stent apparatus 830 includes a primary conduit 838, a second conduit 844, a third conduit (shown, but not labeled in Figure 8D), and a fourth conduit 850, each configured to facilitate vascular access and device deployment. The support structure 834 is arranged within the primary conduit 838 and includes an bearing point opening 836 positioned to permit ingress and egress of the guidewire 860 and sheath catheter 862. The support structure 834 acts as a bearing point, enabling controlled deflection of the guidewire 860 and sheath catheter 862 as they traverse from the primary conduit 838 into the fourth conduit 850.
[0213] In this embodiment, the guidewire 860 is shown as advanced through the primary conduit 838 and redirected by the bearing point opening 836 of the support structure 834 into the fourth conduit 850. The sheath catheter 862 follows the guidewire 860, engaging the support structure 834 to maintain stability and precision during deployment. The interaction between the sheath catheter 862 and the support structure 834 reduces the unsupported arc length, thereby enhancing pushability and positioning accuracy within the stent apparatus 830. The guidewire 860 and sheath catheter 862 could be similarly advanced through the third conduit.
[0214] The second conduit 844 provides an additional branch pathway for vascular access or device placement. The arrangement of the primary conduit 838, second conduit 844, fourth conduit 850, and support structure 834 enables advanced vascular techniques, such as up-and-over maneuvers, to access complex branch vessels. This configuration demonstrates the technical effect of the integrated support structure 834 in minimizing unsupported arc lengths and improving procedural outcomes in endovascular interventions.
[0215] In embodiments where the support structure is configured to be directly engaged by a guidewire for deflection purposes (such as arch-shaped supports illustrated in Figures 8A-8D), a method for bridging stent deployment utilizes the support structure as an active deflectionGrowIP No. KELL-23-001-WOelement. The method begins with advancing a guidewire via arterial access to a target location in an aorta of a patient, loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire, advancing the first sheath catheter along the guidewire via arterial access to the target location, and deploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location. This initial deployment positions the support structure within the flow path, with the arch or cross-member configured to be engaged by subsequently advanced guidewires.
[0216] The method continues with advancing the guidewire distally within the deployed stent apparatus until the guidewire engages the support structure. Rather than passing through an bearing point opening immediately, the guidewire may slide along the surface of the support structure, particularly in arch-shaped embodiments where the arch presents a curved bearing surface. The operator advances the guidewire until it reaches the apex or highest point of the arch support, where the support structure creates maximum deflection. From this engagement point, the guidewire is redirected by continued advancement, with the flexibility of the guidewire causing it to bend around or deflect off the support structure. The guidewire continues to be advanced, now redirecting toward the second end of the main body along a different trajectory than its initial approach. The guidewire follows this redirected path through the conduit system of the stent apparatus until the guidewire exits the main body and enters a second artery, which may be a branch vessel or a continuation of the aorta depending on the anatomical application. A second sheath catheter containing a bridging stent is loaded onto the distal end of the guidewire and advanced along the guidewire. As the second sheath catheter follows the guidewire path and engages the support structure, the support provides a bearing point that supports the sheath catheter during its deflection, reducing the unsupported arc length and enabling controlled advancement. The bridging stent is deployed by advancing the second sheath catheter into the second artery and deploying the bridging stent to connect the main body or the aorta to the second artery, with the distal end in the second artery and the proximal end in the conduit of the stent apparatus or in the aorta adjacent to the stent apparatus. This method is particularly useful for accessing vessels that branch at acute angles from the main body, where the support structure engagement provides the necessary deflection to achieve the required trajectory.
[0217] In embodiments where the stent apparatus includes a support structure positioned between the proximal end of the main body and a first bifurcation (such as illustrated in Figures 8A-8D), with an opening arranged between the support and the first bifurcation, a method for sequential branch vessel access enables treatment of complex multi-vessel pathology such as thoracoabdominal aortic aneurysms. The method commences with advancing a guidewireGrowIP No. KELL-23-001-WOvia arterial access to a target location in an aorta of a patient, typically positioning the target location super celiac (superior to the celiac artery, in the lower thoracic or upper abdominal aorta). The guidewire is advanced from femoral access in most embodiments, though brachial or axillary access may be used for alternative approaches. A first sheath catheter containing the stent apparatus is loaded onto a distal end of the guidewire, with the stent apparatus constrained in a compressed delivery configuration within the first sheath catheter. The first sheath catheter is advanced along the guidewire via arterial access to the target location, using fluoroscopic guidance and anatomical landmarks (such as the celiac artery origin visible on contrast angiography) to confirm positioning. The stent apparatus is deployed into the aorta and / or a conduit of a previously placed stent or stent graft at the target location, with the support structure positioned to facilitate subsequent access to branch vessels downstream of the support. In one embodiment, the first bifurcation of the stent apparatus is positioned at or slightly above the level of the celiac artery, with the support structure positioned approximately 30-50 mm proximal to the bifurcation, placing the bearing point opening between the support and bifurcation in an optimal position for redirecting catheters toward visceral vessels.
[0218] After deployment of the stent apparatus, the guidewire is advanced through the bearing point opening between the support and the first bifurcation, crossing from the second conduit into the first conduit of the main body, and then distally into the third conduit of the main body until the guidewire exits the main body and enters a super celiac artery such as the celiac artery itself. The guidewire advancement through the bearing point opening involves directing the distal tip of the guidewire from the second conduit toward the support structure, where the guidewire encounters the bearing point of the support. Depending on the support configuration (arch-shaped or cross-member), the guidewire may slide along the support surface until finding the bearing point opening, or may be directed through the bearing point opening by rotational or steering movements. As the guidewire passes through the bearing point opening into the first conduit, the guidewire follows a redirected path toward the third conduit, which branches from the first conduit at the first bifurcation. The guidewire continues through the third conduit, which is oriented toward the celiac artery in this example, and exits the distal end of the third conduit to enter the celiac artery ostium. The guidewire is advanced approximately 50-100 mm into the celiac artery to provide stable support for subsequent catheter advancement. A second sheath catheter containing a first bridging stent is loaded onto the distal end of the guidewire, with the bridging stent sized appropriately for the celiac artery (typically 6-8 mm diameter, 40-60 mm length). The second sheath catheter is advanced along the guidewire and introduced into the super celiac artery, following the path established by the guidewire through the opening, the first conduit, and the third conduit. A distal end of the first bridging stent is deployed into the super celiac artery, and a proximal end of the firstGrowIP No. KELL-23-001-WObridging stent is deployed into the third conduit of the main body, creating a sealed connection between the stent apparatus and the celiac artery that preserves blood flow.
[0219] When the second sheath catheter is advanced through the opening between the support and the first bifurcation during this deployment, the second sheath catheter interacts with the support at the bearing point and is redirected in a distal direction along the guidewire back toward the second end of the main body. This bearing point interaction is a critical feature that distinguishes the method from conventional approaches. As the second sheath catheter approaches the support structure from within the second conduit, the catheter follows the guidewire path toward the opening. The outer surface of the second sheath catheter contacts the support structure at the bearing point, which is configured to present a surface substantially orthogonal or gently angled relative to the catheter's approach direction. This contact causes the sheath catheter to deflect at the bearing point, pivoting around this fulcrum to redirect toward the opening and subsequently toward the distal direction into the first conduit. The unsupported arc that would form without the bearing point (spanning directly from the second conduit to the third conduit in a wide arc) is effectively replaced by two shorter supported segments: a first segment from the catheter entry point to the bearing point, and a second segment from the bearing point through the opening to the third conduit. Each segment has approximately half the radius of curvature of the unsupported configuration, providing approximately four-fold improvement in resistance to buckling or deflection under advancement forces. The operator experiences this as markedly improved pushability, with the catheter tracking smoothly along the guidewire without the hesitation, buckling, or tendency to prolapse that characterizes advancement through unsupported large-radius curves.
[0220] The method continues with retracting the guidewire from the super celiac artery and back into the first conduit of the main body, then advancing the guidewire into the fourth conduit until the guidewire exits the main body and enters a superior mesenteric artery (SMA). The guidewire retraction is performed by withdrawing the guidewire proximally while maintaining its position through the deployed first bridging stent to the celiac artery, ensuring the bridging stent is not displaced. Once the guidewire tip is withdrawn into the first conduit (approximately 20-40 mm proximal to the first bifurcation), the guidewire is redirected into the fourth conduit, which branches from the first conduit at the first bifurcation and is oriented toward the SMA. The guidewire is advanced through the fourth conduit, exits the distal end of the fourth conduit, and enters the SMA ostium. A third sheath catheter containing a second bridging stent is loaded onto the distal end of the guidewire and advanced along the guidewire, introduced into the superior mesenteric artery following the established guidewire path. AGrowIP No. KELL-23-001-WOdistal end of the second bridging stent is deployed into the superior mesenteric artery and a proximal end is deployed into the fourth conduit of the main body, establishing perfusion to the SMA territory. This sequential access to the celiac and SMA through the third and fourth conduits, both accessed via the bearing point opening between the support and the first bifurcation, demonstrates the versatility of the support structure in facilitating multi-vessel access from a single bearing point.
[0221] Following deployment of bridging stents to the visceral vessels, the method may further comprise retracting the guidewire from the superior mesenteric artery and back into the first conduit of the main body, then passing through the bearing point opening in the support structure (or bearing point opening between the support and the bifurcation) and into the second conduit of the main body. A fourth sheath catheter containing a second stent apparatus is loaded onto the distal end of the guidewire and advanced along the guidewire, introduced into the second conduit of the main body. The second stent apparatus is deployed with a proximal end deployed into the second conduit of the main body such that the bearing point opening between the support and the first bifurcation of the first stent apparatus is sealed, and a distal end of the second stent apparatus is deployed into the aorta, extending the repair distally. The sealing of the bearing point opening prevents any potential blood flow through this pathway (Type III endoleak) while the second stent apparatus maintains the flow path through the second conduit to the distal aorta. The proximal end of the second stent apparatus overlaps the second conduit by at least 30 mm for passive fixation and circumferential seal. In some embodiments, the second stent apparatus may itself include a support structure with bearing point opening, enabling further sequential access to additional branch vessels (such as renal arteries) using the same bearing point principle. This modular, sequential approach allows complex multi-level repairs to be constructed in a step-wise manner with each component providing bearing point support for deployment of the next component.
[0222] Figure 8E is a schematic diagram illustrating an internal view of an embodiment of a stent apparatus 800 with an internal arch-shaped support structure. The stent apparatus 800 includes a main body 802 defining a primary conduit 808, with a support structure 804 arranged internally and forming an opening 806. The support structure 804 is anchored within the main body 802 and is positioned adjacent to a first bifurcation 810, which divides the primary conduit 808 into a first conduit 812 and a second conduit 814. A second bifurcation 816 is present within the first conduit 812, forming a third conduit 818 and a fourth conduit 820. The arrangement of the support structure 804 and opening 806 enables controlled ingress and egress of delivery elements, such as guidewires and sheath catheters, while reducing unsupported arc length and providing a bearing point for redirection.GrowIP No. KELL-23-001-WO
[0223] Figure 8F is a schematic diagram illustrating another internal view of an embodiment of a stent apparatus 800 with an internal arch-shaped support structure. The stent apparatus 800 further comprises extensions 870 and 872, which are coupled to the main body 802 and serve to anchor the support structure 804. The opening 806 is maintained in a patent state by the support structure 804, and the configuration is designed to facilitate secure positioning and stability during deployment. The arrangement of the support structure 804 and extensions 870, 872 ensures that the bearing point is robust and that the opening 806 remains accessible for device passage.
[0224] Figure 8G is a schematic diagram illustrating yet another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure. The stent apparatus 800 is shown with the main body 802 and the support structure 804, which is integrated to provide a low-profile, gradual bearing point for delivery elements. The internal arrangement of the support structure 804 minimizes the risk of device entrapment and allows for smooth deflection of guidewires and sheath catheters as they traverse the opening 806.
[0225] Figure 8H is a schematic diagram illustrating another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure. The stent apparatus 800 includes the main body 802, the support structure 804, and the arrangement of branch conduits, including the second conduit 814, third conduit 818, and fourth conduit 820. The support structure 804 is positioned to interact with these conduits, providing a bearing point that enables controlled redirection of delivery elements and maintains patency of the branch conduits.
[0226] Figure 8I is a schematic diagram illustrating yet another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure. The stent apparatus 800 incorporates extensions 870 and 872, which anchor the support structure 804 to the main body 802, and includes an active fixation element 874. This configuration enhances the stability of the support structure 804 and ensures secure placement of the stent apparatus 800 within the target vessel.
[0227] Figure 8J is a schematic diagram illustrating another internal view of an embodiment of a stent apparatus with an internal arch-shaped support structure. The stent apparatus 800 features an active fixation element 874 coupled to the main body 802 and the support structure 804. The active fixation element 874 is designed to engage the native vessel wall or adjacent stent grafts, providing additional resistance to migration and ensuring the stent apparatus 800 remains securely positioned during and after deployment.GrowIP No. KELL-23-001-WO
[0228] Figure 8K is a schematic diagram illustrating an external view of an embodiment of a stent apparatus with an internal arch-shaped support structure, depicting an arrangement of branches and conduits. The stent apparatus 800 is configured with a multi-conduit arrangement, including the main body 802, primary conduit 808, second conduit 814, third conduit 818, fourth conduit 820, fifth conduit 876, and sixth conduit 878. This external view highlights the spatial relationship and arrangement of the branch conduits for complex vascular repair.
[0229] Figure 8L is a schematic diagram illustrating another external view of an embodiment of a stent apparatus with an internal arch-shaped support structure. The stent apparatus 800 is shown with the main body 802, primary conduit 808, second conduit 814, third conduit 818, fourth conduit 820, fifth conduit 876, and sixth conduit 878, demonstrating the multi-branch configuration and the integration of the internal support structure for compatibility with branching vascular systems.
[0230] Figure 8M is a schematic diagram illustrating yet another external view of an embodiment of a stent apparatus with an internal arch-shaped support structure. The stent apparatus 800 combines the multi-conduit arrangement with an active fixation element 874, and includes the main body 802, primary conduit 808, second conduit 814, third conduit 818, fourth conduit 820, fifth conduit 876, and sixth conduit 878. The integration of the support structure and active fixation element 874 ensures secure placement and stability within the vascular system.D. Arch-Shaped Support Extending from First End
[0231] The stent apparatus embodiments where the support is coupled to the first end of the stent such that the support extends from the first end in a direction away from the second end represent a distinct configuration particularly suited for external arch applications and conversion stent scenarios as illustrated in Figures 9A-9F. In this configuration, the support has an arch-shape, meaning the support follows a curved path that arches outward from the main body, with the arch extending in a direction away from the second end (distal end) of the stent apparatus. The arch-shape may be rounded (following a smooth circular or elliptical arc), horseshoe-shaped (forming a U-shaped or C-shaped curve), or squared-off (following a path with relatively straight segments connected by curved transitions), with the specific arch geometry selected based on the desired bearing point position and the anatomical space available external to the stent apparatus. A bearing point opening is arranged between the support and the first end of the stent, meaning the opening is positioned in the space between the arch of the support and the first end (proximal end) of the main body. This bearing pointGrowIP No. KELL-23-001-WOopening provides a passage through which traversing elements such as guidewires, catheters, sheaths and other therapeutic devices can enter and exit.
[0232] The stent includes an expandable metal structure covered by a graft material, with the arch-shaped support extending beyond the graft-covered surface of the main body in external arch embodiments. The expandable metal structure provides the foundational framework that maintains the primary conduit patency and engages the vessel wall or inner surface of a previously-placed stent. The arch-shaped support may be formed from the same material as the stent frame (such as nitinol wire) or from a distinct material selected for specific mechanical properties. The support includes wire in many embodiments, with a wire diameter typically ranging from 0.018 to 0.035 inches, formed into the arch geometry through mandrel shaping and heat treatment. The arch-shape of the support may be rounded, providing a smooth, continuous curve with constant radius; horseshoe-shaped, providing a U-configuration with tighter curves at the ends and a more gradual central span; or squared-off, providing a configuration with relatively straight segments connected by curved corners, which may facilitate manufacturing and provide specific bearing point geometries.
[0233] In embodiments utilizing shape-memory materials such as nitinol, the support is shapememory biased to maintain a patency of the bearing point opening in the support in a deployed condition and to permit compression of the support in a delivery condition. During delivery, the arch-shaped support is compressed toward the main body, reducing the overall profile of the stent apparatus to fit within the delivery catheter. The shape-memory properties, arising from the thermally-induced phase transformation between martensite and austenite crystal structures, cause the support to self-expand upon release from the delivery catheter, restoring the arch to its predetermined configuration. The transformation temperature (austenite finish temperature, Af) is selected to be below body temperature, ensuring complete expansion in vivo. The arch height, measured from the main body surface to the apex of the arch, typically ranges from about 5 mm to about 30 mm depending on the main body diameter and the intended bearing point position. The opening configured to permit ingress and egress of a directional sheath catheter and / or guidewire is defined by the space between the arch support and the first end of the main body, with opening dimensions typically ranging from 8 mm to 25 mm in width to accommodate sheath catheters ranging from 8 French to 16 French.
[0234] The support is configured to be a bearing support acted upon by a traversing element (e.g., a directional sheath catheter and / or a guidewire) received through the bearing point opening to allow the directional sheath catheter and / or the guidewire to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin. The arch geometry positions the bearing point at a location where advancing devices naturally encounter the support duringGrowIP No. KELL-23-001-WOdeflection maneuvers. For example, when a guidewire is advanced through the primary conduit from the second end toward the first end, the guidewire encounters the arch support and is deflected by the arch surface, redirecting the guidewire through the bearing point opening and toward a target vessel. The arch-shaped support is configured to reduce an unsupported arc length of the traversing element by at least half compared to configurations without the support, providing the mechanical advantages described throughout this specification. The support may further include at least one radiopaque marker coupled to the main body of the stent and arranged to permit identification of a location and / or an orientation of the support, with the marker positioned on or near the arch to indicate the bearing point location during fluoroscopy. In some embodiments, the first end of the support and the second end of the support have respective extensions configured to be coupled to the main body of the stent, to the first end of the stent, or to one or more anchoring elements arranged at the first end of the stent. These extensions may include flattened tabs, loops, or other mechanical features that facilitate attachment. The extensions may anchor directly to the main body graft material via sutures or adhesive, or may anchor to the stent frame via welding or mechanical coupling. In conversion stent embodiments, the extensions may anchor to a previously-placed stent that receives the conversion stent apparatus, ensuring the arch support is securely positioned within the host device.E. Arch-Shaped Support Dimensional Specifications and Deployment Considerations
[0235] The arch-shaped support configurations extending from the first end of the stent apparatus provide specific geometric relationships optimized for bearing point effectiveness. The arch height, measured from the first end of the main body to the apex or highest point of the arch, typically ranges from about 10 mm to about 35 mm, selected based on the diameter of the primary conduit and the desired bearing point position. For smaller conduits (10-20 mm diameter), arch heights of 10-15 mm position the bearing point near the central axis of the conduit. For larger conduits (30-60 mm diameter), arch heights of 20-35 mm may be used. The arch span, measured as the distance between the first end and second end of the support where they couple to the first end of the main body, typically ranges from about 10 mm to about 60 mm, generally corresponding to the diameter of the main body at the first end. The arch may follow a smooth curved path with constant radius, or may follow a compound curve with varying radius, or may include straight segments connected by curved transitions, with each geometry providing distinct bearing characteristics.
[0236] The bearing point opening arranged between the support and the first end of the stent is three-dimensional, bounded by the arch support on one side (the side away from the main body), by the first end of the main body on the other side (the side toward the body of the stentGrowIP No. KELL-23-001-WOapparatus), and by the lateral extents of the arch (the positions where the first and second ends of the support couple to the main body). The effective width of this bearing point opening, measured perpendicular to the direction of catheter approach, ranges from about 8 mm to about 25 mm for most embodiments, providing adequate clearance for sheath catheters ranging from 8 French to 14 French with additional space for angulation. The effective height of the bearing point opening, measured along the direction of catheter approach, corresponds to the arch height and provides the distance over which the bearing point can engage advancing devices. Devices entering through this bearing point opening contact the arch support at the bearing point, typically near the apex of the arch, and are deflected by the arch geometry toward the target direction, which may be perpendicular to the main body axis (90-degree deflection) for side branch access or may be reversed relative to the entry direction (up to 180-degree deflection) for up-and-over maneuvers.
[0237] Figure 9A is a schematic diagram illustrating a stent graft 902 prior to installation of a stent apparatus with integrated support for reducing unsupported arc length during deployment. The stent graft 902 includes a main body defining a primary conduit 902a that extends from a proximal end 902 (upper portion, as illustrated) to a distal end (lower portion, as illustrated). At the distal end, the stent graft 902 features a bifurcation that divides into a first secondary branch conduit and a second secondary branch conduit, each configured to facilitate blood flow to separate vascular pathways.
[0238] In the illustrated embodiment, the stent graft 902 is covered by a graft material over an expandable metal scaffold, providing a fluid-tight seal to exclude aneurysmal sacs or reinforce diseased vessel walls. The bifurcation is configured to accommodate traversing elements (e.g., directional sheath catheters or guidewires), facilitating access to branch vessels and enabling up-and-over maneuvers. The design of the bifurcation minimizes unsupported arc lengths at the junction, enhancing deliverability and stability during deployment.
[0239] In a further embodiment, the stent graft 902 is compatible with the placement of bridging stents to connect the secondary branch conduits to additional vascular conduits. This modular configuration allows for tailored treatment strategies to address specific anatomical and pathological conditions while maintaining the integrity of the primary conduit.
[0240] Figure 9B is a schematic diagram conceptually illustrating installation into the stent graft 902 of a stent apparatus 900 having an integrated external arch-shaped support structure 904 for reducing unsupported arc length.GrowIP No. KELL-23-001-WO
[0241] The stent apparatus 900 is configured for placement within the stent graft 902 and includes the external support structure 904 arranged in an arch-shaped configuration. The external support structure 904 is positioned to extend outwardly from the stent apparatus 900, providing a bearing point for a directional sheath catheter or guidewire during endovascular procedures. This arrangement enables the traversing element to deflect in a controlled manner, thereby reducing the unsupported arc length and improving procedural accuracy.
[0242] In certain embodiments, the external support structure 904 is formed from a biocompatible, shape-memory material that maintains an arch-shaped profile during deployment and adapts to dynamic vascular forces. The stent apparatus 900 may further include additional fixation features to enhance seal integrity and limit endoleak. The external support structure 904 may be configured in various geometries, such as rounded, horseshoeshaped, or squared-off, to optimize directional support for guidewires or sheath catheters introduced through the conduit of the stent graft 902.
[0243] The stent apparatus 900 and the stent graft 902 are designed to be compatible with a range of vascular anatomies and procedural requirements, facilitating precise and stable delivery of bridging stents or other endovascular devices.
[0244] Figure 9C is a schematic diagram illustrating the stent graft 902 with the installed conversion stent apparatus 900 having an integrated external arch-shaped support structure 904 for reducing unsupported arc length during deployment.
[0245] The conversion stent apparatus 900 includes the external arch-shaped support structure 904 coupled to the conversion stent apparatus 900 and arranged to provide a bearing point for a guidewire, sheath catheter, or other delivery system during endovascular procedures involving the stent graft 902 and its vascular branches. The external support structure 904 is positioned to interact with a traversing element, such as a guidewire or sheath catheter, as the traversing element is advanced through the stent graft 902. This interaction enables controlled deflection and redirection of the traversing element, thereby reducing the unsupported arc length and enhancing procedural stability and accuracy. The support structure 904 may be formed from a biocompatible material, such as a shape-memory alloy, to maintain the configuration of the support structure during both delivery and deployment.
[0246] The conversion stent apparatus 900 may further include features to facilitate integration with native vasculature or previously placed stent grafts and may be configured to receive bridging stents for connection to branch vessels. In some embodiments, radiopaqueGrowIP No. KELL-23-001-WOmarkers may be provided to assist with imaging-guided placement and orientation of the conversion stent apparatus 900.
[0247] The arrangement of the external support structure 904 and the conversion stent apparatus 900 in Figure 9C provides a technical effect of reducing the unsupported arc length of delivery elements, thereby improving pushability, minimizing the risk of vessel trauma, and supporting precise navigation through complex vascular anatomy.
[0248] Figure 9D is a schematic diagram illustrating a deployed guidewire and sheath catheter 906 utilizing the stent graft 902 with installed conversion stent apparatus 900 having an integrated external arch-shaped support structure 904 for reducing unsupported arc length. The external support 904 is positioned adjacent to the stent graft 902 and is configured to act as a bearing point for the sheath catheter 906. The sheath catheter 906 is arranged to deflect from a first direction 908 to a second direction 910 at the bearing point, thereby reducing the unsupported arc length of the sheath catheter 906 during deployment.
[0249] In one embodiment, the external support 904 provides mechanical stability and controlled redirection of the sheath catheter 906, enabling precise navigation through complex vascular geometries. By shortening the unsupported arc length, the external support 904 enhances pushability and minimizes the potential for vessel trauma or device instability.
[0250] In another embodiment, the sheath catheter 906 interacts with the external support 904 at a defined bearing point to facilitate a smooth transition between a first direction 908 and a second direction 910. This interaction supports accurate positioning of the stent apparatus 902 within the target vessel and preserves the structural integrity of the sheath catheter 906.
[0251] In a further embodiment, the conversion stent apparatus 900 demonstrates the integration of an external support structure 904 with a stent apparatus 902 to address challenges associated with unsupported arc lengths, thereby improving the deliverability and stability of the stent apparatus system and facilitating advanced techniques for branch vessel access.
[0252] Figure 9E is a schematic diagram illustrating front, side, and top views of one embodiment of a conversion stent apparatus 920 having an integrated external arch-shaped support structure 924, according to an example embodiment.
[0253] As shown in the front view, the conversion stent apparatus 920 includes a main stent body with an external arch-shaped support 924 positioned near the upper region of the stentGrowIP No. KELL-23-001-WObody. The support 924 is configured to act as a bearing point 926 for a directional sheath catheter and / or guidewire during deployment, thereby reducing the unsupported arc length of the traversing element. The arch-shaped configuration of the support 924 provides a low-profile bearing point 926 that facilitates controlled deflection of the traversing element, enabling precise navigation through complex vascular conduits.
[0254] In the side view, the external support 924 is shown extending outwardly from the main stent body. The bearing point 926 is arranged to interact with a directional sheath catheter or guidewire, allowing the traversing element to deflect smoothly and maintain stability as the traversing element passes through the stent apparatus 920. This arrangement reduces the risk of device instability and vessel trauma by limiting the unsupported arc length.
[0255] In the top view, the conversion stent apparatus 920 is depicted with a circular configuration, demonstrating the alignment of the external support 924 with the geometry of the stent body. The support 924 is positioned to provide structural assistance to traversing elements, ensuring compatibility with the overall design and functionality of the apparatus. The integration of the external support 924 into the conversion stent apparatus 920 offers advantages such as improved deliverability, enhanced positioning accuracy, and reduced procedural complexity during endovascular interventions.
[0256] Figure 9F is a schematic diagram illustrating the conversion stent apparatus 920 deployed in a native blood vessel 934 and providing a reduced unsupported arc length to an advancing sheath catheter 906, according to an example embodiment.
[0257] The conversion stent apparatus 920 comprises a tubular stent body positioned within the native blood vessel 934, the stent body defining an internal conduit for passage of the sheath catheter 906. An external support 924 is coupled to the stent body and extends outwardly to form a bearing structure that engages the sheath catheter 906. The external support 924 is configured to reduce the unsupported arc length of the sheath catheter 906 during deployment, thereby enhancing stability and precision of catheter navigation.
[0258] In one embodiment, the external support 924 is dimensioned and positioned such that the arc length of the sheath catheter 906 unsupported by the stent body is reduced by at least 50 percent, facilitating controlled advancement through the vessel. The tubular stent body of the conversion stent apparatus 920 may be fabricated from a biocompatible, self-expanding material exhibiting sufficient radial force to maintain vessel patency while accommodating the geometry of the native blood vessel 934.GrowIP No. KELL-23-001-WO
[0259] In another embodiment, the conversion stent apparatus 920, in combination with the external support 924, enables the sheath catheter 906 to perform up-and-over maneuvers or access branch vessels with improved mechanical performance and reduced procedural difficulty. This configuration ensures enhanced deliverability, precise positioning, and reduced risk of complications during minimally invasive vascular interventions.
[0260] Figure 10A is a schematic diagram illustrating an isometric view of one embodiment of a conversion stent apparatus with antegrade and retrograde anchors. The conversion stent apparatus 1000 includes an external support 1004, which is configured to provide structural reinforcement and facilitate the reduction of unsupported arc lengths during deployment. The external support 1004 is positioned to interact with traversing elements, e.g., directional sheath catheters and guidewires, acting as a bearing point to enable controlled deflection. Anchors 1006 are integrated into the design to provide antegrade and retrograde fixation, ensuring stability and secure placement of the stent apparatus 1000 within the target vessel. The anchors 1006 are strategically arranged to resist movement and maintain alignment during endovascular procedures.
[0261] Figure 10B is a schematic diagram illustrating a front view of one embodiment of a conversion stent apparatus 1000 with antegrade and retrograde anchors. The external support 1004 spans the upper portion of the conversion stent apparatus 1000, providing a low-profile structure designed to prevent device entrapment and adverse interactions with adjacent anatomy. The anchors 1006 are distributed along the length of the conversion stent apparatus 1000, ensuring uniform fixation and stability. This view emphasizes the integration of the external support 1004 and anchors 1006 within the conversion stent apparatus 1000, showcasing the roles of these components in enhancing deliverability and positioning accuracy.
[0262] Figure 10C is a schematic diagram illustrating a side view of one embodiment of a conversion stent apparatus 1000 with antegrade and retrograde anchors. The external support 1004 is shown extending along the upper section of the apparatus, providing a gradual and smooth configuration to facilitate controlled deflection of traversing elements. The anchors 1006 are positioned along the sides of the apparatus, ensuring secure engagement with the vessel walls. This view highlights the streamlined design of the stent apparatus 1000, minimizing interference with native anatomy while maintaining structural integrity during deployment.
[0263] Figure 10D is a schematic diagram illustrating a top / bottom view of one embodiment of a conversion stent apparatus 1000 with antegrade and retrograde anchors. The top andGrowIP No. KELL-23-001-WObottom views provide a cross-sectional perspective of the orientation of the conversion stent apparatus 1000. These views complement the previously described components by illustrating the spatial arrangement and structural features of the conversion stent apparatus 1000. The top view emphasizes the alignment of the external support 1004 and anchors 1006, while the bottom view provides insight into the overall configuration of the stent apparatus 1000. Together, these views enhance understanding of the design and functionality of the conversion stent apparatus 1000 in reducing unsupported arc lengths and improving procedural outcomes.
[0264] Figure 11A is a schematic diagram illustrating placement of a bridging stent 1134 via a stent apparatus 1100 in proximity to the celiac artery 1130 and superior mesenteric artery 1132 during an endovascular procedure, according to an example embodiment.
[0265] The stent apparatus 1100 is deployed within an aorta 1128 and includes a main body 1102 defining a primary conduit 1108. A cross-member support 1104 is positioned within the main body 1102 and forms a bearing point opening 1106 configured to permit traversal of a sheath catheter 1126 and a guidewire 1124. The support 1104 acts as a bearing point for the sheath catheter 1126 and guidewire 1124, reducing unsupported arc length and enabling controlled deflection as these elements are advanced through the stent apparatus 1100.
[0266] The main body 1102 includes a first bifurcation 1110 that divides the primary conduit 1108 into a first conduit 1112 and a second conduit 1114. A second bifurcation 1116 further divides the flow path into a third conduit 1118 and a fourth conduit 1120, facilitating access to branch vessels. The bridging stent 1134 is shown extending from the stent apparatus 1100 into the celiac artery 1130, having been deployed over the guidewire 1124 redirected through the bearing point opening 1106 and into the target branch vessel. The stent apparatus 1100 may further include active fixation 1122 to secure anchoring within the aorta 1128 and maintain alignment with the branch vessels.
[0267] This arrangement allows for precise placement of bridging stents into the celiac artery 1130 and superior mesenteric artery 1132, with the support 1104 reducing the unsupported arc length of the sheath catheter 1126 and guidewire 1124, thereby enhancing deliverability and stability during complex endovascular procedures.
[0268] In one embodiment, the method for deployment of the stent apparatus involves the use of a guidewire with varying stiffness levels to accommodate different anatomical challenges. For example, a highly flexible guidewire may be used for navigating tortuous arterial pathways, while a stiffer guidewire may be employed for more direct access to the target location. TheGrowIP No. KELL-23-001-WOsheath catheter containing the stent apparatus can be configured with a radiopaque marker to enhance visibility during fluoroscopic imaging, ensuring precise placement at the target location. In another embodiment, the sheath catheter may include a directional tip that allows for controlled deflection, enabling the operator to navigate complex vascular structures and align the stent apparatus with a previously placed stent or conduit. The stent apparatus itself may feature a shape-memory support structure that maintains patency during deployment and adapts to the vessel's curvature, reducing the risk of migration or misalignment. Additionally, the deployment process may incorporate active fixation elements, such as hooks or anchors, to secure the stent apparatus within the artery or conduit, ensuring stability post-deployment. In yet another embodiment, the method may utilize a sheath catheter with a multi-lumen design, allowing simultaneous deployment of additional therapeutic devices, such as bridging stents, to address adjacent vascular issues. The guidewire and sheath catheter may also be coated with biocompatible materials to minimize friction and reduce the risk of endothelial damage during advancement.
[0269] Figure 11B is a schematic diagram illustrating an installed system of vascular stent apparatuses 1100, 1140 deployed within a branching arterial system, according to an example embodiment. The system includes a first stent apparatus 1100 positioned proximally within a main arterial conduit and a second stent apparatus 1140 arranged distally and extending into one or more branch vessels. A bridging stent 1134 is interposed between the first stent apparatus 1100 and the second stent apparatus 1140 to provide a continuous, sealed pathway for blood flow and device delivery.
[0270] The first stent apparatus 1100 includes a main body configured to support the deployment of additional stent apparatuses and bridging stents, and is structured to reduce unsupported arc lengths during advancement of guidewires and sheath catheters. The second stent apparatus 1140 is dimensioned to match the target branch vessel and is configured for integration with the first stent apparatus 1100 via the bridging stent 1134. The bridging stent 1134 is configured to seal the interface between the first and second stent apparatuses 1100, 1140, and may include radiopaque markers to facilitate imaging-guided alignment and deployment.
[0271] This installed system enables regulated delivery and deployment of traversing elements, e.g., guidewires, catheters, and sheath systems, across complex arterial bifurcations, while maintaining patency of the main conduit and branch conduits. The arrangement of the stent apparatuses and bridging stent 1134 provides mechanical support to reduce the unsupported arc length of delivery elements, thereby improving procedural accuracy and reducing the risk of vessel trauma or device instability.GrowIP No. KELL-23-001-WO
[0272] Figure 11C is a schematic diagram illustrating placement of bridging stents 1134 via stent apparatuses 1100 and 1140 in relation to the celiac artery 1130, superior mesenteric artery 1132, and renal artery 1150, according to an example embodiment.
[0273] The stent apparatus 1100 is positioned within a vascular conduit and includes an internal support 1144 that defines a bearing point 1148. The bearing point 1148 is configured to reduce an unsupported arc length of a guidewire 1124 and a sheath catheter 1126 as they are advanced through the stent apparatus 1100. The support 1144 further defines an bearing point opening 1146, which is arranged to permit ingress and egress of traversing elements, i.e., the guidewire 1124 and the sheath catheter 1126, thereby facilitating controlled deflection and redirection of these elements for precise navigation into branch vessels.
[0274] The bridging stents 1134 are deployed through the opening 1146 and are positioned to extend from the stent apparatus 1100 into the celiac artery 1130, superior mesenteric artery 1132, and renal artery 1150. The system further includes a second stent apparatus 1140, which is arranged downstream of the primary stent apparatus 1100 and includes a similar support structure for assisting in the deployment of additional bridging stents 1134 into branch vessels.
[0275] This arrangement enables sequential or simultaneous access to multiple branch vessels while maintaining patency and stability of the conduits. The configuration of the support 1144 and the opening 1146 within the stent apparatus 1100 provides a bearing point for the guidewire 1124 and the sheath catheter 1126, thereby reducing the risk of uncontrolled expansion and improving procedural accuracy during endovascular interventions.V. Deployment Systems and Techniques
[0276] The stent apparatus is deployed using a delivery system comprising a guidewire, delivery catheter with retractable sheath, and optional accessory devices. The guidewire is typically a 0.035 inch or 0.038 inch diameter guidewire with length ranging from 180 cm to 300 cm depending on the access route, with the distal 10-20 cm having a flexible hydrophilic tip to facilitate navigation through tortuous anatomy. The delivery catheter includes an inner shaft with an outer sheath that constrains the stent apparatus in a compressed configuration, with the sheath having an inner diameter typically 18-24 French for aortic components or 12-16 French for iliac components. During deployment, the stent apparatus is loaded into the delivery catheter with the second end loaded first in some embodiments to enable antegrade deployment, or with the first end loaded first for retrograde deployment. The constrained stent apparatus is advanced over the guidewire to the target location under fluoroscopic guidance, using radiopaque markers to confirm positioning. The outer sheath is then retracted proximallyGrowIP No. KELL-23-001-WOwhile the inner shaft is held stationary, allowing the stent apparatus to self-expand sequentially from the second end to the first end or vice versa depending on loading orientation. The controlled unsheathing rate typically ranges from about 5 mm per second to about 20 mm per second, allowing gradual expansion while monitoring position. During the unsheathing of the support structure region, particular attention is paid to ensure the bearing point opening in the support structure is oriented toward the target branch vessel(s), which may require rotation of the entire delivery system before full release. After deployment of the stent apparatus, subsequent guidewires and sheath catheters for bridging stent deployment may be advanced through the opening in the support structure, utilizing the bearing point to achieve controlled redirection toward the target vessels.
[0277] The stent apparatus may be deployed in either antegrade (moving with blood flow) or retrograde (against blood flow) orientation depending on the anatomical location and access route. Antegrade deployment is preferred for descending thoracic and intrarenal applications accessed from femoral approach, as the natural taper of the delivery catheter and the direction of blood flow assist with tracking and positioning. The second end of the stent apparatus is loaded first into the delivery catheter for antegrade deployment, and after positioning, the stent expands from the second end to the first end, with the first end engaging the vessel wall last to establish seal and fixation. Retrograde deployment is utilized for aortic arch and ascending aorta applications accessed from femoral approach, where the stent apparatus must be advanced up and over the arch. In retrograde deployment, the first end (largest diameter) is loaded first and the stent is deployed from the first end to the second end, allowing the larger first end to engage the ascending aorta while the distal components extend into the arch or descending aorta. Fortransapical approaches (accessing ascending aorta directly through left ventricular apex), antegrade deployment is used but with the device loaded in reverse orientation. The support structure orientation is considered in these deployment strategies to ensure the opening is positioned to facilitate the intended directional catheter maneuvers, typically orienting the opening toward the branch vessels to be accessed in subsequent steps. Radiopaque directional markers on the main body assist the operator in confirming proper rotational alignment before final deployment.VI. ExamplesA. Example 1: Endovascular Debranching of Thoracoabdominal Aortic Aneurysm Using Stent Apparatus with Integrated Support
[0278] In one representative clinical example of treating a thoracoabdominal aortic aneurysm using the stent apparatus with integrated support structure: A patient presents with a Crawford Type II thoracoabdominal aortic aneurysm extending from the mid-thoracic aorta to below theGrowIP No. KELL-23-001-WOrenal arteries. Under general anesthesia, bilateral femoral access and right axillary artery access are obtained. An anchoring visceral double-barreled main body stent graft (proximal diameter 36 mm, length 110 mm) is deployed in the thoracic aorta with the distal end positioned approximately 110 mm above the celiac artery. A stent apparatus according to the present invention, having a main body with primary conduit diameter of 20 mm, a septum with 10 mm fenestration, and bifurcating into four tertiary conduits of 7 mm diameter, is deployed within one conduit of the double-barreled graft with approximately 45 mm of overlap for passive fixation. Through the axillary access using an 8 French sheath, a 0.035 inch guidewire is advanced down the thoracic aorta and into the second conduit of the stent apparatus. The guidewire engages the septum adjacent to the fenestration, and with gentle advancement, deflects through the fenestration into the first conduit and extends distally into the tertiary conduit corresponding to the celiac artery. The guidewire exits the stent apparatus and enters the celiac artery ostium. A 10 French sheath catheter is advanced over the guidewire, and as the sheath passes through the fenestration, it contacts the upper edge of the fenestration (bearing point), causing controlled redirection. The unsupported arc length is reduced from approximately 40 mm to approximately 18 mm due to the bearing point interaction. A 7 mm x 40 mm covered bridging stent is deployed through the sheath with the distal end in the celiac artery and the proximal end in the tertiary conduit of the stent apparatus, establishing perfusion. This process is repeated for the superior mesenteric artery and both renal arteries, completing the visceral debranching while maintaining perfusion throughout the procedure without requiring aortic cross-clamping or cardiopulmonary bypass.VII. Clauses
[0279] The following are example clauses describing certain aspects set forth herein.
[0280] Clause 1. A stent apparatus, comprising:
[0281] a stent comprising a main body, a first end, a second end, and at least one conduit extending between the first end and the second end;
[0282] a support arranged within the main body, the support having a first end and a second end, wherein the support is arranged as a cross-member such that the first end and the second end of the support are coupled to opposing sides of the main body; and
[0283] a bearing point opening arranged between the support and the second end of the stent.
[0284] Clause 2. The stent apparatus of clause 1, wherein the stent has an expandable metal structure covered by a graft material.GrowIP No. KELL-23-001-WO
[0285] Clause 3. The stent apparatus according to any one of clauses 1-2, wherein the support is rounded, horseshoe-shaped, or squared-off.
[0286] Clause 4. The stent apparatus according to any one of clauses 1-3, wherein the support comprises wire.
[0287] Clause 5. The stent apparatus according to any one of clauses 1-4, wherein the support is shape-memory biased to maintain a patency of the bearing point opening in the support in a deployed condition and to permit compression of the support in a delivery condition
[0288] Clause 6. The stent apparatus according to any one of clauses 1-5, wherein the bearing point opening is configured to permit ingress and egress of a traversing element therethrough, wherein the support is configured to act as a bearing point acted upon by the traversing element during deployment of the traversing element to allow the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element.
[0289] Clause 7. The stent apparatus according to clause 6, wherein the support is configured to reduce an unsupported arc length of the traversing element by at least half.
[0290] Clause 8. The stent apparatus according to any one of clauses 1 -7, further comprising at least one radiopaque marker coupled to the main body of the stent and arranged to permit identification of a location and / or an orientation of the support.
[0291] Clause 9. The stent apparatus according to any one of clauses 1-8, wherein the first end of the support and the second end of the support have respective extensions configured to be coupled to the main body of the stent.
[0292] Clause 10. A stent apparatus, comprising:
[0293] a stent comprising a main body, a first end, a second end, and at least one conduit extending between the first end and the second end;
[0294] a support coupled to the first end of the stent such that the support extends from the first end of the stent in a direction away from the second end of the stent, wherein the support has an arch-shape; and
[0295] a bearing point opening arranged between the support and the first end of the stent.GrowIP No. KELL-23-001-WO
[0296] Clause 11. The stent apparatus of clause 10, wherein the stent has an expandable metal structure covered by a graft material.
[0297] Clause 12. The stent apparatus according to any one of clauses 10-11, wherein the arch-shape of the support is rounded, horseshoe-shaped, or squared-off.
[0298] Clause 13. The stent apparatus according to any one of clauses 10-12, wherein the support comprises wire.
[0299] Clause 14. The stent apparatus according to any one of clauses 10-13, wherein the support is shape-memory biased to maintain a patency of the bearing point opening in the support in a deployed condition and to permit compression of the support in a delivery condition.
[0300] Clause 15. The stent apparatus according to any one of clauses 10-14, wherein the support is configured to be a bearing support acted upon by a traversing element received through the bearing point opening to allow the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element.
[0301] Clause 16. The stent apparatus according to clause 15, wherein the support is configured to reduce an unsupported arc length of the traversing element by at least half.
[0302] Clause 17. The stent apparatus according to any one of clauses 10-16, further comprising at least, one radiopaque marker coupled to the body of the stent and arranged to permit identification of a location and / or an orientation of the support.
[0303] Clause 18. The stent apparatus according to any one of clauses 10-17, wherein the first end of the support and the second end of the support have respective extensions configured to be coupled to the main body of the stent, the first end of the stent, or one or more anchoring elements arranged at the first end of the stent.
[0304] Clause 19. A method for deployment of the stent apparatus according to any one of clauses 1-18, the method comprising:
[0305] advancing a guidewire, via arterial access, to a target location in a first artery of a person;
[0306] loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;GrowIP No. KELL-23-001-WO
[0307] advancing the first sheath catheter along the guidewire, via arterial access, to the target location; and
[0308] deploying the stent apparatus into the first artery and / or a first conduit of a previously placed stent or stent graft at the target location.
[0309] Clause 20. The method according to clause 19, further comprising:
[0310] advancing the guidewire through the bearing point opening of the stent apparatus thereby crossing from the at least one conduit and back, into the first artery or into a second conduit of the previously placed stent or stent graft until the guidewire exits the main body of the stent and enters a second artery;
[0311] loading a second sheath catheter containing a first bridging stent or a therapeutic device onto a distal end of the guidewire;
[0312] advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the second artery; and
[0313] deploying the therapeutic device or a distal end of the first bridging stent into the second artery and deploying a proximal end into the first artery or the second conduit of the previously placed stent.
[0314] Clause 21. The method according to any one of clauses 19-20, wherein, when the second sheath catheter is advanced through the bearing point opening, the second sheath catheter interacts with an apex or bearing point of the support thereby reducing an unsupported arc length of the second sheath catheter by at least half.
[0315] Clause 22. A stent apparatus, comprising:
[0316] a stent graft comprising a main body, the main body having a primary conduit and a first bifurcation forming two secondary branches defining a first conduit and a second conduit;
[0317] a support arranged within the main body, the support having a first end and a second end, wherein the support is arranged as a cross-member such that the first end and the second end of the support are coupled to opposing sides of the main body above the first bifurcation, or wherein the support has an arch-shape such that the first end and the second end of the support are coupled to opposing ends of the first bifurcation; and
[0318] a bearing point opening arranged between the support and the bifurcation, wherein the bearing point opening is configured to permit ingress and egress of a traversing elementGrowIP No. KELL-23-001-WOtherethrough, and wherein the support is configured to act as a bearing point acted upon by the traversing element during deployment of the traversing element.
[0319] Clause 23. The stent apparatus of clause 22, wherein the stent graft comprises an expandable metal frame covered by a graft material.
[0320] Clause 24. The stent apparatus according to any one of clauses 22-23, wherein the support comprises wire.
[0321] Clause 25. The stent apparatus according to any one of clauses 22-24, wherein the support is arch-shaped and the arch-shape of the support is rounded, horseshoe-shaped, or squared-off.
[0322] Clause 26. The stent apparatus according to any one of clauses 22-25, wherein the wire of the support is shape- memory biased to maintain a patency of the bearing point opening in a deployed condition and to permit compression of the support in a delivery condition.
[0323] Clause 27. The stent apparatus according to any one of clauses 22-26, wherein the support is configured to allow the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element when in contact with the support.
[0324] Clause 28. The stent apparatus according to any one of clauses 22-27, wherein the support is configured to reduce an unsupported arc length of the traversing element by at least half.
[0325] Clause 29. The stent apparatus according to any one of clauses 22-28, further comprising at least one radiopaque marker coupled to the main body of the stent graft and arranged to permit identification of a location and / or an orientation of the support.
[0326] Clause 30. The stent apparatus according to any one of clauses 22-29, wherein the first end of the support and the second end of the support have respective extensions configured to be coupled to the first bifurcation or to the opposing walls of the main body.
[0327] Clause 31. The stent apparatus according to any one of clauses 22-30, further comprising a second bifurcation within the first conduit forming two tertiary branches defining a third conduit and a fourth conduit in the main body.
[0328] Clause 32. The stent apparatus according to any one of clauses 22-31, wherein the diameter of the primary conduit ranges from about 10 mm to about 60 mm.GrowIP No. KELL-23-001-WO
[0329] Clause 33. The stent apparatus according to any one of clauses 22-32, wherein a diameter of the third conduit ranges from about 3 mm to about 10 mm, and wherein a diameter of the fourth conduit ranges from about 3 mm to about 10 mm.
[0330] Clause 34. The stent apparatus according to any one of clauses 22-33, wherein a diameter of the second conduit ranges from about 5 mm to about 40 mm.
[0331] Clause 35. The stent apparatus according to any one of clauses 22-34, wherein a length of the third conduit ranges from about 1 cm to about 5 cm, and wherein a length of the fourth conduit ranges from about 1 cm to about 5 cm.
[0332] Clause 36. The stent apparatus according to any one of clauses 22-35, wherein a distance from the first end of the main body to the bearing point of the support ranges from 0 cm to about 10 cm.
[0333] Clause 37. The stent apparatus according to any one of clauses 22-36, wherein a diameter, length, or width of the bearing point opening ranges from about 3 mm to about 20 mm.
[0334] Clause 38. The stent apparatus according to any one of clauses 22-37, further comprising a third bifurcation within the second conduit forming two quaternary branches defining a fifth conduit and a sixth conduit.
[0335] Clause 39. The stent apparatus according to clause 38, wherein a distance from the first bifurcation to the third bifurcation within the second conduit ranges from 0 cm to about 20 cm.
[0336] Clause 40. The stent apparatus according to clause 39, wherein a length of the fifth conduit ranges from 0 cm to about 5 cm, and wherein a length of the sixth conduit ranges from 0 cm to about 5 cm.
[0337] Clause 41. The stent apparatus according to clause 40, wherein a diameter of the fifth conduit ranges from about 5 mm to about 40 mm, and wherein a diameter of the sixth conduit ranges from about 5 mm to about 40 mm.
[0338] Clause 42. The stent apparatus according to any one of clauses 22-32, wherein the diameter of the first conduit ranges from about 5 mm to about 30 mm.
[0339] Clause 43. The stent apparatus according to any one of clauses 22-32 and 42, wherein the diameter of the second conduit ranges from 5 mm to 55 mm.GrowIP No. KELL-23-001-WO
[0340] Clause 44. The stent apparatus according to any one of clauses 22-32 and 42-43, wherein the diameter of the third conduit ranges from about 4 mm to about 20 mm, and wherein the diameter of the fourth conduit ranges from about 4 mm to about 20 mm.
[0341] Clause 45. The stent apparatus according to any one of clauses 22-32 and 42-44, wherein the length of the third conduit ranges from 0 m to about 80 mm and wherein the length of the fourth conduit ranges from 0 mm to about 80 mm.
[0342] Clause 46. The stent apparatus according to any one of clauses 22-32 and 41-45, wherein the fourth conduit is longer than the third conduit.
[0343] Clause 47. The stent apparatus according to any one of clauses 22-32 and 41-46, wherein a distance from the first end of the main body to a first end of the septum ranges from 0 mm to 200 mm.
[0344] Clause 48. The stent apparatus according to any one of clauses 22-32 and 41-47, wherein a length between a first end of the septum to the first end of the bearing point opening ranges from 0.1 mm to 200 mm.
[0345] Clause 49. The stent apparatus according to any one of clauses 22-32 and 41-48, wherein the bearing point opening in the septum ranges from about 0.1 mm to 30 mm across.
[0346] Clause 50. The stent apparatus according to any one of clauses 22-49, further comprising active fixation coupled to an exterior of the main body, the active fixation being exposed or concealed and configured to resist movement in a proximal direction opposite to blood flow upon deployment of the stent apparatus in a target vessel.
[0347] Clause 51. The stent apparatus according to any one of clauses 31-50, wherein the second bifurcation in the first conduit, forming the two tertiary branches is arranged either parallel to or orthogonal to the support.
[0348] Clause 52. A method for deployment of the stent apparatus according to any one of clauses 22-51, the method comprising:
[0349] advancing a guidewire, via arterial access, to a target location in an aorta of a patient;
[0350] loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;
[0351] advancing the first sheath catheter along the guidewire, via arterial access, to the target location; andGrowIP No. KELL-23-001-WO
[0352] deploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location.
[0353] Clause 53. The method according to clause 52, wherein the target location is arranged super celiac within the aorta.
[0354] Clause 54. The method according to any one of clauses 52-53, further comprising:
[0355] advancing the guidewire through the bearing point opening between the support and the first bifurcation crossing from the second conduit and into the first conduit of the main body and then distally into the third conduit of the main body until the guidewire exits the main body and enters a super celiac artery;
[0356] loading a second sheath catheter containing a first bridging stent onto a distal end of the guidewire;
[0357] advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the super celiac artery; and
[0358] deploying a distal end of the first bridging stent into the super celiac artery and deploying a proximal end of the first bridging stent into the third conduit of the main body.
[0359] Clause 55. The method according to clause 54, wherein, when the second sheath catheter is advanced through the bearing point opening between the support and the first bifurcation, the second sheath catheter interacts with the support at the bearing point and is redirected in a distal direction along the guidewire back toward the second end of the main body.
[0360] Clause 56. The method according to clause 55, further comprising:
[0361] retracting the guidewire from the super celiac artery and back into the first conduit of the main body;
[0362] advancing the guidewire into the fourth conduit until the guidewire exits the main body and enters a superior mesentery artery;
[0363] loading a third sheath catheter containing a second bridging stent onto a distal end of the guidewire;
[0364] advancing the third sheath catheter along the guidewire and introducing the third sheath catheter into the superior mesentery artery; andGrowIP No. KELL-23-001-WO
[0365] deploying a distal end of the second bridging stent into the superior mesentery artery and deploying a proximal end into the fourth conduit of the main body.
[0366] Clause 57. The method according to clause 56, further comprising:
[0367] retracting the guidewire from the superior mesentery artery and back into the first conduit of the main body through the bearing point opening between the support and the first bifurcation and into the second conduit of the main body;
[0368] loading a fourth sheath catheter containing a second stent apparatus according to any one of clauses 22-40 onto a distal end of the guidewire;
[0369] advancing the fourth sheath catheter along the guidewire and introducing the fourth sheath catheter into the second conduit of the main body; and
[0370] deploying a proximal end of the second stent apparatus into the second conduit of the main body such that the bearing point opening between the support and the first bifurcation of the first stent apparatus is sealed and deploying a distal end of the second stent apparatus into the aorta.
[0371] Clause 58. The method according to clause 57, further comprising:
[0372] advancing the guidewire through the bearing point opening between the support and the first bifurcation of the main body of the second stent apparatus thereby crossing from the second conduit and into the first conduit of the main body and then distally into the third conduit of the main body until the guidewire exits the main body and enters a right renal artery;
[0373] loading a fifth sheath catheter containing a third bridging stent onto a distal end of the guidewire;
[0374] advancing the fifth sheath catheter along the guidewire and introducing the fifth sheath catheter into the right renal artery;
[0375] deploying a distal end of the third bridging stent into the right renal artery and deploying a proximal end of the third bridging stent into the third conduit of the main body of the second stent apparatus.
[0376] Clause 59. The method according to clause 58, further comprising:
[0377] retracting the guidewire from the right renal artery and back into the first conduit of the main body of the second stent apparatus;GrowIP No. KELL-23-001-WO
[0378] advancing the guidewire into the fourth conduit until the guidewire exits the main body of the second stent apparatus and enters a left renal artery;
[0379] loading a sixth sheath catheter containing a fourth bridging stent onto a distal end of the guidewire;
[0380] advancing the sixth sheath catheter along the guidewire and introducing the sixth sheath catheter into the left renal artery; and
[0381] deploying a distal end of the fourth bridging stent into the left renal artery and deploying a proximal end of the fourth bridging stent into the fourth conduit of the main body of the second stent apparatus.
[0382] Clause 60. The method according to clause 59, further comprising:
[0383] retracting the guidewire from the left renal artery and back into the first conduit of the main body of the second stent apparatus through the bearing point opening between the support and the first bifurcation and into the second conduit of the main body;
[0384] loading a seventh sheath catheter containing a fifth bridging stent onto a distal end of the guidewire;
[0385] advancing the seventh sheath catheter along the guidewire and introducing the seventh sheath catheter into the second conduit of the main body of the second stent apparatus;
[0386] deploying a proximal end of the seventh bridging stent into the second conduit of the main body such that the bearing point opening between the support and the first bifurcation of the second stent apparatus is sealed and deploying a distal end of the seventh bridging stent into the aorta to receive additional bridging stents for extension into right and left iliac arteries to thereby exclude an aneurysm.
[0387] Clause 61. A stent apparatus, comprising:
[0388] a main body having a primary conduit;
[0389] a support arranged within the main body, the support having a first end and a second end each coupled to the main body; and
[0390] a bearing point opening arranged within the support and configured to permit ingress and egress of a traversing element therethrough, and wherein the support is configured to actGrowIP No. KELL-23-001-WOas a bearing point acted upon by the traversing element during deployment of the traversing element.
[0391] Clause 62. The stent apparatus of clause 61, wherein the main body has an expandable metal frame covered by a graft material.
[0392] Clause 63. The stent apparatus according to any of clauses 61-62, wherein the main body has a first bifurcation forming two secondary branches defining a first conduit and a second conduit, and (a) wherein the support is arranged as a cross-member such that the first end and the second end of the support are coupled to opposing sides of the main body above the first bifurcation, or (b) wherein the support has an arch-shape such that the first end of the support and the second end of the support are coupled to opposing ends of the first bifurcation.
[0393] Clause 64. The stent according to any one of clauses 61-63, wherein the support comprises wire.
[0394] Clause 65. The stent apparatus according to any one of clauses 61-64, wherein the support is arch-shaped and the arch-shape of the support is rounded, horseshoe-shaped, or squared-off.
[0395] Clause 66. The stent apparatus according to any one of clauses 61-65, wherein the support is shape-memory biased to maintain a patency of the bearing point opening in a deployed condition and to permit compression of the support in a delivery condition.
[0396] Clause 67. The stent apparatus according to any one of clauses 61-66, wherein the support is configured to allow the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element when in contact with the support.
[0397] Clause 68. The stent apparatus according to any one of clauses 61-67, wherein the support is configured to reduce an unsupported arc length of the traversing element by at least half.
[0398] Clause 69. The stent apparatus according to any one of clauses 61-68, further comprising at least one radiopaque marker coupled to the main body of the stent and arranged to permit identification of a location and / or an orientation of the support.
[0399] Clause 70. The stent apparatus according to any one of clauses 61-69, wherein the first end of the support and the second end of the support have respective extensions configured to be coupled to the first bifurcation or to the opposing walls of the main body.GrowIP No. KELL-23-001-WO
[0400] Clause 71. A method for deployment of the stent apparatus according to any one of clauses 61-70, the method comprising:
[0401] advancing a guidewire, via arterial access, to a target location in an aorta of a person;
[0402] loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;
[0403] advancing the first sheath catheter along the guidewire, via arterial access, to the target location; and
[0404] deploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location.
[0405] Clause 72. The method according to clause 71, further comprising:
[0406] advancing the guidewire to engage the support thereby being redirected toward the second end of the main body until the guidewire exits the main body and enters a second artery;
[0407] loading a second sheath catheter containing a first bridging stent onto a distal end of the guidewire;
[0408] advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the second artery;
[0409] deploying a distal end of the first bridging stent into the second artery and deploying a proximal end of the first bridging stent into the main body or the aorta.
[0410] Clause 73. A stent apparatus, comprising:
[0411] a main body defining a primary conduit at a first end of the main body;
[0412] a septum having a first end and a second end, the septum arranged within the main body thereby forming two secondary branches defining a first conduit and a second conduit, wherein a first portion of the septum is uninterrupted and a second portion of the septum comprises a bearing point opening, wherein the uninterrupted portion of the septum is configured to act as a bearing wall for a traversing element during deployment of the traversing element; andGrowIP No. KELL-23-001-WO
[0413] a bifurcation within the first conduit forming two tertiary branches defining a third conduit and a fourth conduit in the main body, wherein the bifurcation is arranged opposite the septum from the primary conduit.
[0414] Clause 74. The stent apparatus according to clause 73, wherein the main body has an expandable metal structure covered by a graft material.
[0415] Clause 75. The stent apparatus according to any one of clauses 73-74, wherein the diameter of the primary conduit ranges from about 10 mm to about 60 mm.
[0416] Clause 76. The stent apparatus according to any one of clauses 73-75, wherein a diameter of the third conduit ranges from about 3 mm to about 10 mm, and wherein a diameter of the fourth conduit ranges from about 3 mm to about 10 mm.
[0417] Clause 77. The stent apparatus according to any one of clauses 73-76, wherein the diameter of the second conduit ranges from about 5 mm to about 40 mm.
[0418] Clause 78. The stent apparatus according to any one of clauses 73-77, wherein a length of the third conduit ranges from about 1 cm to about 5 cm, and wherein a length of the fourth conduit ranges from about 1 cm to about 5 cm.
[0419] Clause 79. The stent apparatus according to any one of clauses 73-78, wherein a distance from the first end of the main body to the first end of the septum ranges from 0 cm to about 10 cm.
[0420] Clause 80. The stent apparatus according to any one of clauses 73-79, wherein a distance across the bearing point opening ranges from about 3 mm to about 20 mm.
[0421] Clause 81. The stent apparatus according to any one of clauses 73-80, wherein a distance from the second end of the septum to a second end of the second conduit ranges from 0 cm to about 10 cm.
[0422] Clause 82. The stent apparatus according to any one of clauses 73-81, further comprising a bifurcation within the second conduit forming two quaternary branches defining a fifth conduit and a sixth conduit.
[0423] Clause 83. The stent apparatus according to clause 82, wherein a distance from the second end of the septum to the bifurcation within the second conduit ranges from 0 cm to about 20 cm.GrowIP No. KELL-23-001-WO
[0424] Clause 84. The stent apparatus according to any one of clauses 82-83, wherein a length of the fifth conduit ranges from 0 cm to about 5 cm, and wherein a length of the sixth conduit ranges from 0 cm to about 5 cm.
[0425] Clause 85. The stent apparatus according to any one of clauses 82-84, wherein a diameter of the fifth conduit ranges from about 5 mm to about 40 mm, and wherein a diameter of the sixth conduit ranges from about 5 mm to about 40 mm
[0426] Clause 86. The stent apparatus according to any one of clauses 73-74, wherein the diameter of the first conduit ranges from about 5 mm to about 30 mm.
[0427] Clause 87. The stent apparatus according to any one of clauses 73-74 and 86, wherein the diameter of the second conduit ranges from 5 mm to 55 mm.
[0428] Clause 88. The stent apparatus according to any one of clauses 73-74 and 86-87, wherein the diameter of the third conduit ranges from about 4 mm to about 20 mm, and wherein the diameter of the fourth conduit ranges from about 4 mm to about 20 mm.
[0429] Clause 89. The stent apparatus according to any one of clauses 73-74 and 86-88, wherein the length of the third conduit ranges from 0 mm to about 80 mm and wherein the length of the fourth conduit, ranges from 0 mm to about 80 mm.
[0430] Clause 90. The stent apparatus according to any one of clauses 73-74 and 86-89, wherein the fourth conduit is longer than the third conduit.
[0431] Clause 91. The stent apparatus according to any one of clauses 73-74 and 86-90, wherein a distance from the first end of the main body to the first end of the septum ranges from 0 mm to 200 mm.
[0432] Clause 92. The stent apparatus according to any one of clauses 73-74 and 86-91, wherein a length between the first end of the septum to the first end of the bearing point opening ranges from 0.1 mm to 200 mm.
[0433] Clause 93. The stent apparatus according to any one of clauses 73-74 and 86-92, wherein a length between a first end and a second end of the bearing point opening in the septum ranges from about 0.1 mm to 30 mm.
[0434] Clause 94. The stent apparatus according to any one of clauses 73-93, wherein the bearing point opening in the septum is round or polygonal.GrowIP No. KELL-23-001-WO
[0435] Clause 95. The stent apparatus according to any one of clauses 73-94, wherein a width of the bearing point opening in the septum ranges from about 3 mm to about 20 mm.
[0436] Clause 96. The stent apparatus according to any one of clauses 73-94, wherein a width of the bearing point opening in the septum spans a width of the main body.
[0437] Clause 97. The stent apparatus according to any one of clauses 73-96, further comprising at least one radiopaque marker coupled to the septum or to the main body and arranged to permit identification of a location and / or an orientation of the opening in the septum and / or the main body during placement of the stent apparatus.
[0438] Clause 98. The stent apparatus according to any one of clauses 73-97, wherein the at least one radiopaque marker is coupled to the septum and is arranged to reinforce the bearing point opening in the septum.
[0439] Clause 99. The stent apparatus according to any one of clauses 73-98, further comprising a one-way flap gate coupled to the first end of the bearing point opening in the septum and configured to rotate into the first conduit in response to a force imposed by a guidewire or a sheath catheter.
[0440] Clause 100. The stent apparatus according to any one of clauses 73-99, further comprising active fixation coupled to an exterior of the main body that is exposed or concealed and is configured to resist movement in a proximal direction opposite to blood flow upon deployment in a target vessel.
[0441] Clause 101. The stent apparatus according to any one of clauses 73-100, wherein the bifurcation in the first conduit forming the two tertiary branches is arranged either parallel to or orthogonal to the septum.
[0442] Clause 102. A method for deployment of the stent apparatus according to any one of clauses 73-101, the method comprising:
[0443] advancing a guidewire, via arterial access, to a target location in an aorta of a person;
[0444] loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;
[0445] advancing the first sheath catheter along the guidewire, via arterial access, to the target location; andGrowIP No. KELL-23-001-WO
[0446] deploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location.
[0447] Clause 103. The method according to clause 102, wherein the target location is arranged super celiac within the aorta.
[0448] Clause 104. The method according to clause 103, further comprising:
[0449] advancing the guidewire through the bearing point opening in the septum crossing from the second conduit, and into the first conduit of the main body and then distally into the third conduit of the main body until the guidewire exits the main body and enters a super celiac artery;
[0450] loading a second sheath catheter containing a first bridging stent onto a distal end of the guidewire;
[0451] advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the super celiac artery;
[0452] deploying a distal end of the first bridging stent into the super celiac artery and deploying a proximal end of the first bridging stent into the third conduit of the main body.
[0453] Clause 105. The method according to clause 104, wherein, when the second sheath catheter is advanced through the bearing point opening in the septum, the second sheath catheter interacts with the uninterrupted portion of the septum acting as the bearing wall and is redirected in a distal direction along the guidewire back toward the second end of the main body.
[0454] Clause 106. The method according to clause 105, further comprising:
[0455] retracting the guidewire from the super celiac artery and back into the first conduit of the main body;
[0456] advancing the guidewire into the fourth conduit until the guidewire exits the main body and enters a superior mesentery artery;
[0457] loading a third sheath catheter containing a second bridging stent onto a distal end of the guidewire;
[0458] advancing the third sheath catheter along the guidewire and introducing the third sheath catheter into the superior mesentery artery; andGrowIP No. KELL-23-001-WO
[0459] deploying a distal end of the second bridging stent into the superior mesentery artery and deploying a proximal end of the second bridging stent into the fourth conduit of the main body.
[0460] Clause 107. The method according to clause 106, further comprising:
[0461] retracting the guidewire from the superior mesentery artery and back into the first conduit of the main body through the bearing point opening in the septum and into the second conduit of the main body;
[0462] loading a fourth sheath catheter containing a second stent apparatus according to any one of clauses 73-101 onto a distal end of the guidewire;
[0463] advancing the fourth sheath catheter along the guidewire and introducing the fourth sheath catheter into the second conduit of the main body;
[0464] deploying a proximal end of the second stent apparatus into the second conduit of the main body such that the bearing point opening in the septum of the first stent apparatus is sealed and deploying a distal end of the second stent apparatus into the aorta.
[0465] Clause 108. The method according to clause 107, further comprising:
[0466] advancing the guidewire through the bearing point opening in the septum of the main body of the second stent apparatus thereby crossing from the second conduit and into the first conduit of the main body and then distally into the third conduit of the main body until the guidewire exits the main body and enters a right renal artery;
[0467] loading a fifth sheath catheter containing a third bridging stent onto a distal end of the guidewire;
[0468] advancing the fifth sheath catheter along the guidewire and introducing the fifth sheath catheter into the right renal artery;
[0469] deploying a distal end of the third bridging stent into the right renal artery and deploying a proximal end of the third bridging stent into the third conduit of the main body of the second stent apparatus.
[0470] Clause 109. The method according to clause 108, further comprising:
[0471] retracting the guidewire from the right renal artery and back into the first conduit of the main body of the second stent apparatus;GrowIP No. KELL-23-001-WO
[0472] advancing the guidewire into the fourth conduit until the guidewire exits the main body of the second stent apparatus and enters a left renal artery;
[0473] loading a sixth sheath catheter containing a fourth bridging stent onto a distal end of the guidewire;
[0474] advancing the sixth sheath catheter along the guidewire and introducing the sixth sheath catheter into the left renal artery; and
[0475] deploying a distal end of the fourth bridging stent into the left renal artery and deploying a proximal end of the fourth bridging stent into the fourth conduit of the main body of the second stent apparatus.
[0476] Clause 110. The method according to clause 109, further comprising:
[0477] retracting the guidewire from the left renal artery and back into the first conduit of the main body of the second stent apparatus through the bearing point opening in the septum and into the second conduit of the main body;
[0478] loading a seventh sheath catheter containing a fifth bridging stent onto a distal end of the guidewire;
[0479] advancing the seventh sheath catheter along the guidewire and introducing the seventh sheath catheter into the second conduit of the main body of the second stent apparatus;
[0480] deploying a proximal end of the seventh bridging stent into the second conduit of the main body such that the opening in the septum of the second stent apparatus is sealed and deploying a distal end of the seventh bridging stent into the aorta to receive additional bridging stents for extension into right and left iliac arteries to thereby exclude an aneurysm.
[0481] Clause 111. A stent apparatus, comprising:
[0482] a main body that defines a primary conduit;
[0483] a septum arranged within and coupled to opposing sides of the main body thereby forming two secondary branches defining a first conduit and a second conduit; and
[0484] a bearing point opening arranged in the septum configured to permit ingress and egress of a traversing element therethrough, wherein a portion of the septum surrounding theGrowIP No. KELL-23-001-WObearing point opening is configured to act as a bearing wall for the traversing element during deployment of the traversing element.
[0485] Clause 112. The stent apparatus according to clause 111, wherein the main body has an expandable metal structure covered by a graft material.
[0486] Clause 113. The stent apparatus according to any one of clauses 111-112, further comprising at least one radiopaque marker coupled to the septum or to the main body and arranged to permit identification of a location and / or an orientation of the bearing point opening in the septum and / or the main body during placement of the stent apparatus.
[0487] Clause 114. The stent apparatus according to clause 113, wherein the at least one radiopaque marker is coupled to the septum and is arranged to reinforce the bearing point opening in the septum.
[0488] Clause 115. The stent apparatus according to any one of clauses 111-114, further comprising a one-way flap gate coupled to a first end of the bearing point opening in the septum and configured to rotate into the first conduit in response to a force imposed by the traversing element.
[0489] Clause 116. The stent apparatus according to any one of clauses 111-115, wherein the septum extends from a first end of the main body to a second end of the main body.
[0490] Clause 117. The stent apparatus according to any one of clauses 111-115, wherein a first end of the septum is spaced apart from the first end of the main body such that the primary conduit comprises a single conduit at the first end of the main body, and wherein a second end of the septum is arranged at the second end of the main body.
[0491] Clause 118. The stent apparatus according to any one of clauses 111-115, wherein a first end of the septum is arranged at the first end of the main body, and wherein a second end of the septum is spaced apart from the second end of the main body such that the primary conduit comprises a single conduit at the second end of the main body.
[0492] Clause 119. The stent apparatus according to any one of clauses 111-115, wherein a first end of the septum is spaced apart from the first end of the main body such that the primary conduit comprises a single conduit at the first end of the main body, and wherein a second end of the septum is spaced apart from the second end of the main body such that the primary conduit comprises a single conduit at the second end of the main body.GrowIP No. KELL-23-001-WO
[0493] Clause 120. A method for deployment of the stent apparatus according to any one of clauses 111-119, the method comprising:
[0494] advancing a guidewire, via arterial access, to a target location in an aorta of a patient;
[0495] loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;
[0496] advancing the first sheath catheter along the guidewire, via arterial access, to the target location; and
[0497] deploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location.
[0498] Clause 121. The method according to clause 120, further comprising:
[0499] advancing the guidewire through the bearing point opening in the septum crossing from the second conduit and into the first conduit of the main body and then distally until the guidewire exits the main body and enters the aorta and / or a further target vessel;
[0500] loading a second sheath catheter containing a first bridging stent onto a distal end of the guidewire;
[0501] advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the aorta and / or the further target vessel; and
[0502] deploying a distal end of the first bridging stent into the aorta or the further target vessel and deploying a proximal end of the first bridging stent into the first conduit of the main body.
[0503] Clause 122. The method according to clause 121 wherein, when the second sheath catheter is advanced through the bearing point opening in the septum, the second sheath catheter interacts with the septum at the first end of the bearing point opening and is redirected in a distal direction along the guidewire back toward the second end of the main body
[0504] Clause 123. The method according to clause 122, further comprising:
[0505] retracting the guidewire from the aorta or further target vessel and back into the first conduit of the main body through the bearing point opening in the septum and into the second conduit of the main body;GrowIP No. KELL-23-001-WO
[0506] loading a third sheath catheter containing a second bridging stent apparatus onto a distal end of the guidewire;
[0507] advancing the third sheath catheter along the guidewire and introducing the third sheath catheter into the second conduit of the main body;
[0508] deploying a proximal end of the second bridging stent into the second conduit of the main body such that the bearing point opening in the septum of the first stent apparatus is sealed and deploying a distal end of the second bridging stent into the aorta.
[0509] Clause 124. A stent apparatus, comprising:a stent comprising a main body defining a primary conduit having a length and a width; a support member extending transversally across at least a portion of the width of the primary conduit, the support member including a surface substantially orthogonal to the length of the primary conduit to define a bearing point for a traversing element introduced in a first direction into the length of the primary conduit to reduce an unsupported arc length of the traversing element as the traversing element deflects in a second direction that ranges from 90 degrees and 180 relative to the first direction.
[0510] Clause 125. The stent apparatus of clause 124, wherein the support member is an elongate member comprising a wire, a string, a cord, a rod, a filament, a fiber, and a strip, and wherein a portion of the elongate member serves as the surface that defines the bearing point.
[0511] Clause 126. The stent apparatus of clause 125, wherein the elongate member has a rounded cross section to prevent unintended interference with the element.
[0512] Clause 127. The stent apparatus according to any one of clauses 125-126, wherein the elongate member extends at least partially outside the primary conduit and / or the main body when the stent apparatus is in a deployed condition.
[0513] Clause 128. The stent apparatus according to any one of clauses 125-126, wherein the elongate member is entirely within the primary conduit and the main body when the stent apparatus is in a deployed condition.
[0514] Clause 129. The stent apparatus according to any one of clauses 125-128, wherein the elongate member is shape-memory biased to maintain a patency of the bearing point whenGrowIP No. KELL-23-001-WOthe stent apparatus is in a deployed condition and to permit compression of the elongate member when the stent apparatus is in a delivery condition.
[0515] Clause 130. The stent apparatus of clause 124, wherein the support member is a membrane having a fenestration serving as a bearing point opening, the membrane arranged substantially coplanar with the length of the primary conduit such that a peripheral portion of the fenestration serves as the surface that defines the bearing point.
[0516] Clause 131. The stent apparatus of clause 130, wherein the fenestration is sized large enough to accommodate the traversing element as the traversing element gradually deflects from the first direction toward the second direction.
[0517] Clause 132. The stent apparatus according to any one of clauses 130-131, wherein the membrane includes a flap gate over the fenestration, the flap gate being hinged to close responsive to blood flow, if any, when the stent apparatus is deployed.
[0518] Clause 133. The stent apparatus according to any one of clauses 130-132, wherein the membrane includes one or more peripheral reinforcements around at least a portion of the fenestration.
[0519] Clause 134. The stent apparatus of clause 133, wherein the one or more peripheral reinforcements includes at least one radiopaque marker to permit identification and / or orientation of the support member.
[0520] Clause 135. The stent apparatus according to any one of clauses 124-134, wherein the surface has a flat portion to prevent unintended interference with the traversing element.
[0521] Clause 136. The stent apparatus according to any one of clauses 124-134, wherein the surface has a gradually curved arched portion to prevent unintended interference with the traversing element.
[0522] Clause 137. The stent apparatus of clause 136, wherein the gradually curved portion has a radius of curvature larger than a radius of the traversing element.
[0523] Clause 138. The stent apparatus according to any one of clauses 124-137, wherein the support member is configured to reduce the unsupported arc length of the traversing element by at least half compared to without the support member.
[0524] Clause 139. The stent apparatus according to any one of clauses 124-138, wherein the traversing element is a guidewire, a catheter, a sheath system, or other therapeutic device.GrowIP No. KELL-23-001-WO
[0525] Clause 140. The stent apparatus according to any one of clauses 124-139, wherein the stent has an expandable metal frame covered by a graft material.
[0526] Clause 141. The stent apparatus according to any one of clauses 124-140, wherein the support member is coupled to opposing sides of the main body.
[0527] Clause 142. The stent apparatus according to any one of clauses 124-141, wherein the main body includes a first bifurcation separating the primary conduit into two secondary branches defining a first conduit and a second conduit, and wherein the traversing element is configured to be introduced into the second conduit and is deflected into the first conduit.
[0528] Clause 143. The stent apparatus of clause 142, wherein the support member is coupled to the first bifurcation.
[0529] Clause 144. The stent apparatus according to any one of clauses 124-143, further comprising a second bifurcation separating the first conduit into two tertiary branches defining a third conduit and a fourth conduit.VIII. Conclusion
[0530] The above detailed description sets forth various features and operations of the disclosed systems, apparatus, devices, and / or methods with reference to the accompanying figures. The example embodiments described herein and in the figures are not meant to be limiting, with the true scope being indicated by the following claims. Many modifications and variations can be made without departing from its scope, as will be apparent to those skilled in the art. Functionally equivalent systems, apparatus, devices, and / or methods within the scope of the disclosure, in addition to those described herein, will be apparent to those skilled in the art from the foregoing descriptions. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations. Such modifications and variations are intended to fall within the scope of the appended claims. Finally, all publications, patents, and patent applications cited herein are hereby incorporated herein by reference for all purposes.
Claims
GrowIP No. KELL-23-001-WOClaims1. A stent apparatus, comprising:a stent comprising a main body, a first end, a second end, and at least one conduit extending between the first end and the second end;a support arranged within the main body, the support having a first end and a second end, wherein the support is arranged as a cross-member such that the first end and the second end of the support are coupled to opposing sides of the main body; anda bearing point opening arranged between the support and the second end of the stent.
2. The stent apparatus of claim 1, wherein the stent has an expandable metal structure covered by a graft material.
3. The stent apparatus according to any one of claims 1-2, wherein the support is rounded, horseshoe-shaped, or squared-off.
4. The stent apparatus according to any one of claims 1-3, wherein the support comprises wire.
5. The stent apparatus according to any one of claims 1 -4, wherein the support is shape-memory biased to maintain a patency of the bearing point opening in the support in a deployed condition and to permit compression of the support in a delivery condition.
6. The stent apparatus according to any one of claims 1-5, wherein the bearing point opening is configured to permit ingress and egress of a traversing element therethrough, wherein the support is configured to act as a bearing point acted upon by the traversing element during deployment of the traversing element to allow the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element.
7. The stent apparatus according to claim 6, wherein the support is configured to reduce an unsupported arc length of the traversing element by at least half.
8. The stent apparatus according to any one of claims 1 -7, further comprising at least one radiopaque marker coupled to the main body of the stent and arranged to permit identification of a location and / or an orientation of the support.GrowIP No. KELL-23-001-WO9. The stent apparatus according to any one of claims 1-8, wherein the first end of the support and the second end of the support have respective extensions configured to be coupled to the main body of the stent.
10. A stent apparatus, comprising:a stent comprising a main body, a first end, a second end, and at least one conduit extending between the first end and the second end;a support coupled to the first end of the stent such that the support, extends from the first end of the stent in a direction away from the second end of the stent, wherein the support has an arch-shape; anda bearing point opening arranged between the support and the first end of the stent.
11. The stent apparatus of claim 10, wherein the stent has an expandable metal structure covered by a graft material.
12. The stent apparatus according to any one of claims 10-11, wherein the arch-shape of the support is rounded, horseshoe-shaped, or squared-off.
13. The stent apparatus according to any one of claims 10-12, wherein the support comprises wire.
14. The stent apparatus according to any one of claims 10-13, wherein the support is shape-memory biased to maintain a patency of the bearing point opening in the support in a deployed condition and to permit compression of the support in a delivery condition.
15. The stent apparatus according to any one of claims 10-14, wherein the support is configured to be a bearing support acted upon by a traversing element received through the bearing point opening to allow the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element.
16. The stent apparatus according to claim 15, wherein the support is configured to reduce an unsupported arc length of the traversing element by at least half.
17. The stent apparatus according to any one of claims 10-16, further comprising at least one radiopaque marker coupled to the body of the stent and arranged to permit identification of a location and / or an orientation of the support.GrowIP No. KELL-23-001-WO18. The stent apparatus according to any one of claims 10-17, wherein the first end of the support and the second end of the support have respective extensions configured to be coupled to the main body of the stent, the first end of the stent, or one or more anchoring elements arranged at the first end of the stent.
19. A method for deployment of the stent apparatus according to any one of claims 1-18, the method comprising:advancing a guidewire, via arterial access, to a target location in a first, artery of a person;loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire:advancing the first sheath catheter along the guidewire, via arterial access, to the target location; anddeploying the stent apparatus into the first artery and / or a first conduit of a previously placed stent or stent graft at the target location.
20. The method according to claim 19, further comprising:advancing the guidewire through the bearing point opening of the stent apparatus thereby crossing from the at least one conduit and back into the first artery or into a second conduit of the previously placed stent or stent graft until the guidewire exits the main body of the stent and enters a second artery;loading a second sheath catheter containing a first bridging stent or a therapeutic device onto a distal end of the guidewire;advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the second artery; anddeploying the therapeutic device or a distal end of the first bridging stent into the second artery and deploying a proximal end into the first artery or the second conduit of the previously placed stent.
21. The method according to any one of claims 19-20, wherein, when the second sheath catheter is advanced through the bearing point opening, the second sheath catheter interactsGrowIP No. KELL-23-001-WOwith an apex or bearing point of the support thereby reducing an unsupported arc length of the second sheath catheter by at least half.
22. A stent apparatus, comprising:a stent graft comprising a main body, the main body having a primary conduit and a first bifurcation forming two secondary branches defining a first conduit and a second conduit;a support arranged within the main body, the support having a first end and a second end, wherein the support is arranged as a cross-member such that, the first end and the second end of the support are coupled to opposing sides of the main body above the first bifurcation, or wherein the support has an arch-shape such that the first end and the second end of the support are coupled to opposing ends of the first bifurcation; anda bearing point, opening arranged between the support and the bifurcation, wherein the bearing point opening is configured to permit ingress and egress of a traversing element therethrough, and wherein the support is configured to act as a bearing point acted upon by the traversing element during deployment of the traversing element.
23. The stent apparatus of claim 22, wherein the stent graft comprises an expandable metal frame covered by a graft material.
24. The stent apparatus according to any one of claims 22-23, wherein the support comprises wire.
25. The stent apparatus according to any one of claims 22-24, wherein the support is arch-shaped and the arch-shape of the support is rounded, horseshoe-shaped, or squared-off.
26. The stent apparatus according to any one of claims 22-25, wherein the wire of the support is shape-memory biased to maintain a patency of the bearing point opening in a deployed condition and to permit compression of the support in a delivery condition.
27. The stent apparatus according to any one of claims 22-26, wherein the support is configured to allow the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element when in contact with the support 28. The stent apparatus according to any one of claims 22-27, wherein the support is configured to reduce an unsupported arc length of the traversing element by at least half.GrowIP No. KELL-23-001-WO29. The stent apparatus according to any one of claims 22-28, further comprising at least one radiopaque marker coupled to the main body of the stent graft and arranged to permit identification of a location and / or an orientation of the support.
30. The stent apparatus according to any one of claims 22-29, wherein the first end of the support and the second end of the support have respective extensions configured to be coupled to the first bifurcation or to the opposing walls of the main body.31 The stent apparatus according to any one of claims 22-30, further comprising a second bifurcation within the first conduit forming two tertiary branches defining a third conduit and a fourth conduit in the main body.
32. The stent apparatus according to any one of claims 22-31, wherein the diameter of the primary conduit, ranges from about 10 mm to about 60 mm.
33. The stent apparatus according to any one of claims 22-32, wherein a diameter of the third conduit ranges from about 3 mm to about 10 mm, and wherein a diameter of the fourth conduit ranges from about 3 mm to about 10 mm.
34. The stent apparatus according to any one of claims 22-33, wherein a diameter of the second conduit ranges from about 5 mm to about 40 mm.35 The stent apparatus according to any one of claims 22-34, wherein a length of the third conduit ranges from about 1 cm to about 5 cm, and wherein a length of the fourth conduit ranges from about 1 cm to about 5 cm.
36. The stent apparatus according to any one of claims 22-35, wherein a distance from the first end of the main body to the bearing point of the support ranges from 0 cm to about 10 cm.
37. The stent apparatus according to any one of claims 22-36, wherein a diameter, length, or width of the bearing point opening ranges from about 3 mm to about 20 mm.
38. The stent apparatus according to any one of claims 22-37, further comprising a third bifurcation within the second conduit forming two quaternary branches defining a fifth conduit and a sixth conduit.GrowIP No. KELL-23-001-WO39. The stent apparatus according to claim 38, wherein a distance from the first bifurcation to the third bifurcation within the second conduit ranges from 0 cm to about. 20 cm.
40. The stent apparatus according to claim 39, wherein a length of the fifth conduit ranges from 0 cm to about 5 cm, and wherein a length of the sixth conduit ranges from 0 cm to about 5 cm.
41. The stent apparatus according to claim 40, wherein a diameter of the fifth conduit ranges from about 5 mm to about 40 mm, and wherein a diameter of the sixth conduit ranges from about 5 mm to about 40 mm.
42. The stent apparatus according to any one of claims 22-32, wherein the diameter of the first conduit ranges from about 5 mm to about 30 mm.
43. The stent apparatus according to any one of claims 22-32 and 42, wherein the diameter of the second conduit ranges from 5 mm to 55 mm.
44. The stent apparatus according to any one of claims 22-32 and 42-43, wherein the diameter of the third conduit ranges from about 4 mm to about 20 mm, and wherein the diameter of the fourth conduit ranges from about 4 mm to about 20 mm.
45. The stent, apparatus according to any one of claims 22-32 and 42-44, wherein the length of the third conduit ranges from 0 mm to about 80 mm and wherein the length of the fourth conduit ranges from 0 mm to about 80 mm.
46. The stent apparatus according to any one of claims 22-32 and 41-45, wherein the fourth conduit is longer than the third conduit.
47. The stent apparatus according to any one of claims 22-32 and 41-46, wherein a distance from the first end of the main body to a first end of the septum ranges from 0 mm to 200 mm.
48. The stent apparatus according to any one of claims 22-32 and 41-47, wherein a length between a first end of the septum to the first end of the bearing point opening ranges from 0.1 mm to 200 mm.
49. The stent apparatus according to any one of claims 22-32 and 41-48, wherein the bearing point opening in the septum ranges from about 0.1 mm to 30 mm across.GrowIP No. KELL-23-001-WO50. The stent apparatus according to any one of claims 22-49, further comprising active fixation coupled to an exterior of the main body, the active fixation being exposed or concealed and configured to resist movement in a proximal direction opposite to blood flow upon deployment of the stent apparatus in a target vessel.
51. The stent apparatus according to any one of claims 31-50, wherein the second bifurcation in the first conduit forming the two tertiary branches is arranged either parallel to or orthogonal to the support.
52. A method for deployment of the stent apparatus according to any one of claims 22-51, the method comprising:advancing a guidewire, via arterial access, to a target location in an aorta of a patient; loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;advancing the first sheath catheter along the guidewire, via arterial access, to the target location; anddeploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location.
53. The method according to claim 52, wherein the target location is arranged super celiac within the aorta.
54. The method according to any one of claims 52-53, further comprising:advancing the guidewire through the bearing point opening between the support and the first bifurcation crossing from the second conduit and into the first conduit of the main body and then distally into the third conduit of the main body until the guidewire exits the main body and enters a super celiac artery;loading a second sheath catheter containing a first bridging stent onto a distal end of the guidewire;advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the super celiac artery; andGrowIP No. KELL-23-001-WOdeploying a distal end of the first bridging stent into the super celiac artery and deploying a proximal end of the first bridging stent into the third conduit of the main body.
55. The method according to claim 54, wherein, when the second sheath catheter is advanced through the bearing point opening between the support and the first bifurcation, the second sheath catheter interacts with the support at the bearing point and is redirected in a distal direction along the guidewire back toward the second end of the main body.
56. The method according to claim 55, further comprising:retracting the guidewire from the super celiac artery and back into the first conduit of the main body;advancing the guidewire into the fourth conduit until the guidewire exits the main body and enters a superior mesentery artery;loading a third sheath catheter containing a second bridging stent onto a distal end of the guidewire;advancing the third sheath catheter along the guidewire and introducing the third sheath catheter into the superior mesentery artery; anddeploying a distal end of the second bridging stent into the superior mesentery artery and deploying a proximal end into the fourth conduit of the main body57. The method according to claim 56, further comprising:retracting the guidewire from the superior mesentery artery and back into the first conduit of the main body through the bearing point opening between the support and the first bifurcation and into the second conduit of the main body;loading a fourth sheath catheter containing a second stent apparatus according to any one of claims 22-40 onto a distal end of the guidewire;advancing the fourth sheath catheter along the guidewire and introducing the fourth sheath catheter into the second conduit of the main body; anddeploying a proximal end of the second stent apparatus into the second conduit of the main body such that the bearing point opening between the support and the first bifurcation ofGrowIP No. KELL-23-001-WOthe first stent apparatus is sealed and deploying a distal end of the second stent apparatus into the aorta.
58. The method according to claim 57, further comprising:advancing the guidewire through the bearing point opening between the support and the first bifurcation of the main body of the second stent apparatus thereby crossing from the second conduit and into the first conduit of the main body and then distally into the third conduit of the main body until the guidewire exits the main body and enters a right renal artery; loading a fifth sheath catheter containing a third bridging stent onto a distal end of the guidewire;advancing the fifth sheath catheter along the guidewire and introducing the fifth sheath catheter into the right renal artery;deploying a distal end of the third bridging stent into the right renal artery and deploying a proximal end of the third bridging stent into the third conduit of the main body of the second stent apparatus.
59. The method according to claim 58, further comprising:retracting the guidewire from the right renal artery and back into the first conduit of the main body of the second stent apparatus;advancing the guidewire into the fourth conduit until the guidewire exits the main body of the second stent apparatus and enters a left renal artery;loading a sixth sheath catheter containing a fourth bridging stent onto a distal end of the guidewire;advancing the sixth sheath catheter along the guidewire and introducing the sixth sheath catheter into the left renal artery; anddeploying a distal end of the fourth bridging stent into the left renal artery and deploying a proximal end of the fourth bridging stent into the fourth conduit of the main body of the second stent apparatus.
60. The method according to claim 59, further comprising:GrowIP No. KELL-23-001-WOretracting the guidewire from the left renal artery and back into the first conduit of the main body of the second stent apparatus through the bearing point opening between the support and the first bifurcation and into the second conduit of the main body;loading a seventh sheath catheter containing a fifth bridging stent onto a distal end of the guidewire;advancing the seventh sheath catheter along the guidewire and introducing the seventh sheath catheter into the second conduit of the main body of the second stent apparatus;deploying a proximal end of the seventh bridging stent into the second conduit of the main body such that the bearing point opening between the support and the first bifurcation of the second stent apparatus is sealed and deploying a distal end of the seventh bridging stent into the aorta to receive additional bridging stents for extension into right and left iliac arteries to thereby exclude an aneurysm.
61. A stent apparatus, comprising:a main body having a primary conduit;a support arranged within the main body, the support having a first end and a second end each coupled to the main body; anda bearing point opening arranged within the support and configured to permit ingress and egress of a traversing element therethrough, and wherein the support is configured to act as a bearing point acted upon by the traversing element during deployment of the traversing element.
62. The stent apparatus of claim 61, wherein the main body has an expandable metal frame covered by a graft material.
63. The stent apparatus according to any of claims 61-62, wherein the main body has a first bifurcation forming two secondary branches defining a first conduit and a second conduit, and (a) wherein the support is arranged as a cross-member such that the first end and the second end of the support are coupled to opposing sides of the main body above the firstGrowIP No. KELL-23-001-WObifurcation, or (b) wherein the support has an arch-shape such that the first end of the support and the second end of the support are coupled to opposing ends of the first bifurcation.
64. The stent according to any one of claims 61-63, wherein the support comprises wire.
65. The stent apparatus according to any one of claims 61-64, wherein the support is arch-shaped and the arch-shape of the support is rounded, horseshoe-shaped, or squared-off.
66. The stent apparatus according to any one of claims 61-65, wherein the support is shape-memory biased to maintain a patency of the bearing point opening in a deployed condition and to permit compression of the support in a delivery condition.
67. The stent apparatus according to any one of claims 61-66, wherein the support is configured to allow the traversing element to deflect in a direction ranging from 90 degrees to 180 degrees from a point of origin of the traversing element when in contact with the support 68. The stent apparatus according to any one of claims 61-67, wherein the support is configured to reduce an unsupported arc length of the traversing element by at least half.
69. The stent apparatus according to any one of claims 61-68, further comprising at least one radiopaque marker coupled to the main body of the stent and arranged to permit identification of a location and / or an orientation of the support.
70. The stent apparatus according to any one of claims 61-69, wherein the first end of the support and the second end of the support have respective extensions configured to be coupled to the first bifurcation or to the opposing walls of the main body.
71. A method for deployment of the stent apparatus according to any one of claims 61-70, the method comprising:advancing a guidewire, via arterial access, to a target location in an aorta of a person; loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;advancing the first sheath catheter along the guidewire, via arterial access, to the target, location; anddeploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location.GrowIP No. KELL-23-001-WO72. The method according to claim 71, further comprising:advancing the guidewire to engage the support thereby being redirected toward the second end of the main body until the guidewire exits the main body and enters a second artery;loading a second sheath catheter containing a first bridging stent onto a distal end of the guidewire;advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the second artery;deploying a distal end of the first bridging stent into the second artery and deploying a proximal end of the first bridging stent into the main body or the aorta.
73. A stent apparatus, comprising:a main body defining a primary conduit at. a first end of the main body;a septum having a first end and a second end, the septum arranged within the main body thereby forming two secondary branches defining a first conduit and a second conduit, wherein a first portion of the septum is uninterrupted and a second portion of the septum comprises a bearing point opening, wherein the uninterrupted portion of the septum is configured to act as a bearing wall for a traversing element during deployment of the traversing element; anda bifurcation within the first conduit forming two tertiary branches defining a third conduit and a fourth conduit in the main body, wherein the bifurcation is arranged opposite the septum from the primary conduit.
74. The stent apparatus according to claim 73, wherein the main body has an expandable metal structure covered by a graft material.
75. The stent apparatus according to any one of claims 73-74, wherein the diameter of the primary conduit ranges from about 10 mm to about 60 mm.
76. The stent apparatus according to any one of claims 73-75, wherein a diameter of the third conduit ranges from about 3 mm to about 10 mm, and wherein a diameter of the fourth conduit ranges from about 3 mm to about 10 mm.GrowIP No. KELL-23-001-WO77. The stent apparatus according to any one of claims 73-76, wherein the diameter of the second conduit ranges from about 5 mm to about 40 mm.
78. The stent apparatus according to any one of claims 73-77, wherein a length of the third conduit ranges from about 1 cm to about 5 cm, and wherein a length of the fourth conduit ranges from about 1 cm to about 5 cm.
79. The stent apparatus according to any one of claims 73-78, wherein a distance from the first end of the main body to the first end of the septum ranges from 0 cm to about 10 cm.
80. The stent apparatus according to any one of claims 73-79, wherein a distance across the bearing point opening ranges from about 3 mm to about 20 mm.
81. The stent apparatus according to any one of claims 73-80, wherein a distance from the second end of the septum to a second end of the second conduit ranges from 0 cm to about 10 cm.
82. The stent apparatus according to any one of claims 73-81, further comprising a bifurcation within the second conduit forming two quaternary branches defining a fifth conduit and a sixth conduit.
83. The stent apparatus according to claim 82, wherein a distance from the second end of the septum to the bifurcation within the second conduit ranges from 0 cm to about 20 cm.
84. The stent apparatus according to any one of claims 82-83, wherein a length of the fifth conduit ranges from 0 cm to about 5 cm, and wherein a length of the sixth conduit ranges from 0 cm to about 5 cm.
85. The stent apparatus according to any one of claims 82-84, wherein a diameter of the fifth conduit ranges from about 5 mm to about 40 mm, and wherein a diameter of the sixth conduit ranges from about 5 mm to about 40 mm.
86. The stent apparatus according to any one of claims 73-74, wherein the diameter of the first conduit ranges from about 5 mm to about 30 mm.
87. The stent apparatus according to any one of claims 73-74 and 86, wherein the diameter of the second conduit ranges from 5 mm to 55 mm.GrowIP No. KELL-23-001-WO88. The stent apparatus according to any one of claims 73-74 and 86-87, wherein the diameter of the third conduit ranges from about 4 mm to about 20 mm, and wherein the diameter of the fourth conduit ranges from about 4 mm to about 20 mm.
89. The stent apparatus according to any one of claims 73-74 and 86-88, wherein the length of the third conduit ranges from 0 mm to about 80 mm and wherein the length of the fourth conduit ranges from 0 mm to about 80 mm.
90. The stent apparatus according to any one of claims 73-74 and 86-89, wherein the fourth conduit is longer than the third conduit.
91. The stent apparatus according to any one of claims 73-74 and 86-90, wherein a distance from the first end of the main body to the first end of the septum ranges from 0 mm to 200 mm92 The stent apparatus according to any one of claims 73-74 and 86-91, wherein a length between the first end of the septum to the first end of the bearing point opening ranges from 0.1 mm to 200 mm.
93. The stent apparatus according to any one of claims 73-74 and 86-92, wherein a length between a first end and a second end of the bearing point, opening in the septum ranges from about 0.1 mm to 30 mm.
94. The stent apparatus according to any one of claims 73-93, wherein the bearing point opening in the septum is round or polygonal.
95. The stent apparatus according to any one of claims 73-94, wherein a width of the bearing point opening in the septum ranges from about 3 mm to about.20 mm.
96. The stent apparatus according to any one of claims 73-94, wherein a width of the bearing point opening in the septum spans a width of the main body.
97. The stent apparatus according to any one of claims 73-96, further comprising at least one radiopaque marker coupled to the septum or to the main body and arranged to permit identification of a location and / or an orientation of the opening in the septum and / or the main body during placement of the stent apparatus.GrowIP No. KELL-23-001-WO98. The stent apparatus according to any one of claims 73-97, wherein the at least one radiopaque marker is coupled to the septum and is arranged to reinforce the bearing point opening in the septum.
99. The stent apparatus according to any one of claims 73-98, further comprising a one¬ way flap gate coupled to the first end of the bearing point opening in the septum and configured to rotate into the first conduit in response to a force imposed by a guidewire or a sheath catheter.
100. The stent apparatus according to any one of claims 73-99, further comprising active fixation coupled to an exterior of the main body that is exposed or concealed and is configured to resist movement in a proximal direction opposite to blood flow upon deployment in a target vessel,101. The stent apparatus according to any one of claims 73-100, wherein the bifurcation in the first conduit forming the two tertiary branches is arranged either parallel to or orthogonal to the septum.
102. A method for deployment of the stent apparatus according to any one of claims 73-101, the method comprising:advancing a guidewire, via arterial access, to a target location in an aorta of a person; loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;advancing the first sheath catheter along the guidewire, via arterial access, to the target, location; anddeploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location.
103. The method according to claim 102, wherein the target location is arranged super celiac within the aorta.
104. The method according to claim 103, further comprising:advancing the guidewire through the bearing point opening in the septum crossing from the second conduit and into the first conduit of the main body and then distally into theGrowIP No. KELL-23-001-WOthird conduit of the main body until the guidewire exits the main body and enters a super celiac artery;loading a second sheath catheter containing a first bridging stent onto a distal end of the guidewire;advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the super celiac artery;deploying a distal end of the first, bridging stent into the super celiac artery and deploying a proximal end of the first bridging stent into the third conduit of the main body.
105. The method according to claim 104, wherein, when the second sheath catheter is advanced through the bearing point opening in the septum, the second sheath catheter interacts with the uninterrupted portion of the septum acting as the bearing wall and is redirected in a distal direction along the guidewire back toward the second end of the main body.
106. The method according to claim 105, further comprising:retracting the guidewire from the super celiac artery and back into the first conduit of the main body;advancing the guidewire into the fourth conduit until the guidewire exits the main body and enters a superior mesentery artery;loading a third sheath catheter containing a second bridging stent onto a distal end of the guidewire;advancing the third sheath catheter along the guidewire and introducing the third sheath catheter into the superior mesentery artery; anddeploying a distal end of the second bridging stent into the superior mesentery artery and deploying a proximal end of the second bridging stent into the fourth conduit of the main body.
107. The method according to claim 106, further comprising:GrowIP No. KELL-23-001-WOretracting the guidewire from the superior mesentery artery and back into the first conduit of the main body through the bearing point opening in the septum and into the second conduit of the main body;loading a fourth sheath catheter containing a second stent apparatus according to any one of claims 73-101 onto a distal end of the guidewire;advancing the fourth sheath catheter along the guidewire and introducing the fourth sheath catheter into the second conduit of the main body;deploying a proximal end of the second stent apparatus into the second conduit of the main body such that the bearing point opening in the septum of the first stent apparatus is sealed and deploying a distal end of the second stent apparatus into the aorta.
108. The method according to claim 107, further comprising:advancing the guidewire through the bearing point opening in the septum of the main body of the second stent apparatus thereby crossing from the second conduit and into the first conduit of the main body and then distally into the third conduit of the main body until the guidewire exits the main body and enters a right renal artery;loading a fifth sheath catheter containing a third bridging stent onto a distal end of the guidewire;advancing the fifth sheath catheter along the guidewire and introducing the fifth sheath catheter into the right renal artery;deploying a distal end of the third bridging stent into the right renal artery and deploying a proximal end of the third bridging stent into the third conduit of the main body of the second stent apparatus.
109. The method according to claim 108, further comprising:retracting the guidewire from the right renal artery and back into the first conduit of the main body of the second stent apparatus;advancing the guidewire into the fourth conduit until the guidewire exits the main body of the second stent apparatus and enters a left renal artery;GrowIP No. KELL-23-001-WOloading a sixth sheath catheter containing a fourth bridging stent onto a distal end of the guidewire;advancing the sixth sheath catheter along the guidewire and introducing the sixth sheath catheter into the left renal artery; anddeploying a distal end of the fourth bridging stent into the left renal artery and deploying a proximal end of the fourth bridging stent into the fourth conduit of the main body of the second stent apparatus110. The method according to claim 109, further comprisingretracting the guidewire from the left renal artery and back into the first conduit of the main body of the second stent apparatus through the bearing point opening in the septum and into the second conduit of the main body;loading a seventh sheath catheter containing a fifth bridging stent onto a distal end of the guidewire;advancing the seventh sheath catheter along the guidewire and introducing the seventh sheath catheter into the second conduit of the main body of the second stent apparatus;deploying a proximal end of the seventh bridging stent into the second conduit of the main body such that the opening in the septum of the second stent apparatus is sealed and deploying a distal end of the seventh bridging stent into the aorta to receive additional bridging stents for extension into right and left iliac arteries to thereby exclude an aneurysm.
111. A stent apparatus, comprising:a main body that defines a primary conduit;a septum arranged within and coupled to opposing sides of the main body thereby forming two secondary branches defining a first conduit and a second conduit; anda bearing point opening arranged in the septum configured to permit ingress and egress of a traversing element therethrough, wherein a portion of the septum surrounding the bearing point opening is configured to act as a bearing wall for the traversing element during deployment of the traversing element.GrowIP No. KELL-23-001-WO112. The stent apparatus according to claim 111, wherein the main body has an expandable metal structure covered by a graft, material113. The stent apparatus according to any one of claims 111-112, further comprising at least one radiopaque marker coupled to the septum or to the main body and arranged to permit identification of a location and / or an orientation of the bearing point opening in the septum and / or the main body during placement of the stent apparatus.
114. The stent apparatus according to claim 113, wherein the at least one radiopaque marker is coupled to the septum and is arranged to reinforce the bearing point opening in the septum.
115. The stent apparatus according to any one of claims 111 - 114, further comprising a one¬ way flap gate coupled to a first end of the bearing point opening in the septum and configured to rotate into the first conduit in response to a force imposed by the traversing element.
116. The stent apparatus according to any one of claims 111-115, wherein the septum extends from a first end of the main body to a second end of the main body.
117. The stent apparatus according to any one of claims 111-115, wherein a first end of the septum is spaced apart from the first end of the main body such that the primary conduit comprises a single conduit at. the first end of the main body, and wherein a second end of the septum is arranged at the second end of the main body.
118. The stent apparatus according to any one of claims 111-115, wherein a first end of the septum is arranged at the first end of the main body, and wherein a second end of the septum is spaced apart from the second end of the main body such that, the primary conduit comprises a single conduit at the second end of the main body.
119. The stent apparatus according to any one of claims 111-115, wherein a first end of the septum is spaced apart from the first end of the main body such that the primary conduit comprises a single conduit at the first end of the main body, and wherein a second end of the septum is spaced apart from the second end of the main body such that the primary conduit comprises a single conduit at the second end of the main body.GrowIP No. KELL-23-001-WO120. A method for deployment of the stent apparatus according to any one of claims 111- 119, the method comprising:advancing a guidewire, via arterial access, to a target location in an aorta of a patient; loading a first sheath catheter containing the stent apparatus onto a distal end of the guidewire;advancing the first sheath catheter along the guidewire, via arterial access, to the target location; anddeploying the stent apparatus into the aorta and / or a conduit of a previously placed stent or stent graft at the target location.
121. The method according to claim 120, further comprising:advancing the guidewire through the bearing point opening in the septum crossing from the second conduit and into the first conduit of the main body and then distally until the guidewire exits the main body and enters the aorta and / or a further target vessel;loading a second sheath catheter containing a first bridging stent onto a distal end of the guidewire;advancing the second sheath catheter along the guidewire and introducing the second sheath catheter into the aorta and / or the further target vessel; anddeploying a distal end of the first bridging stent into the aorta or the further target vessel and deploying a proximal end of the first bridging stent into the first conduit of the main body.
122. The method according to claim 121, wherein, when the second sheath catheter is advanced through the bearing point opening in the septum, the second sheath catheter interacts with the septum at the first end of the bearing point opening and is redirected in a distal direction along the guidewire back toward the second end of the main body.
123. The method according to claim 122, further comprising:retracting the guidewire from the aorta or further target vessel and back into the first conduit of the main body through the bearing point opening in the septum and into the second conduit of the main body;GrowIP No. KELL-23-001-WOloading a third sheath catheter containing a second bridging stent apparatus onto a distal end of the guidewire;advancing the third sheath catheter along the guidewire and introducing the third sheath catheter into the second conduit of the main body;deploying a proximal end of the second bridging stent into the second conduit of the main body such that the bearing point opening in the septum of the first stent apparatus is sealed and deploying a distal end of the second bridging stent into the aorta.
124. A stent apparatus, comprisinga stent comprising a main body defining a primary conduit having a length and a width; a support member extending transversally across at least a portion of the width of the primary conduit, the support member including a surface substantially orthogonal to the length of the primary conduit to define a bearing point for a traversing element introduced in a first direction into the length of the primary conduit to reduce an unsupported arc length of the traversing element as the traversing element deflects in a second direction that ranges from 90 degrees and 180 relative to the first direction.
125. The stent apparatus of claim 124, wherein the support member is an elongate member comprising a wire, a string, a cord, a rod, a filament, a fiber, and a strip, and wherein a portion of the elongate member serves as the surface that defines the bearing point.
126. The stent apparatus of claim 125, wherein the elongate member has a rounded cross section to prevent unintended interference with the element.
127. The stent apparatus according to any one of ciaims 125-126, wherein the elongate member extends at least partially outside the primary conduit and / or the main body when the stent apparatus is in a deployed condition.
128. The stent apparatus according to any one of claims 125-126, wherein the elongate member is entirely within the primary conduit and the main body when the stent apparatus is in a deployed condition.
129. The stent apparatus according to any one of claims 125-128, wherein the elongate member is shape-memory biased to maintain a patency of the bearing point when the stentGrowIP No. KELL-23-001-WOapparatus is in a deployed condition and to permit compression of the elongate member when the stent apparatus is in a delivery condition.
130. The stent apparatus of claim 124, wherein the support member is a membrane having a fenestration serving as a bearing point opening, the membrane arranged substantially coplanarwith the length of the primary conduit such that a peripheral portion of the fenestration serves as the surface that defines the bearing point.
131. The stent apparatus of claim 130, wherein the fenestration is sized large enough to accommodate the traversing element as the traversing element gradually deflects from the first direction toward the second direction.
132. The stent apparatus according to any one of claims 130-131, wherein the membrane includes a flap gate over the fenestration, the flap gate being hinged to close responsive to blood flow, if any, when the stent apparatus is deployed.
133. The stent apparatus according to any one of claims 130-132, wherein the membrane includes one or more peripheral reinforcements around at least a portion of the fenestration.
134. The stent apparatus of claim 133, wherein the one or more peripheral reinforcements includes at least, one radiopaque marker to permit identification and / or orientation of the support member135. The stent apparatus according to any one of claims 124-134, wherein the surface has a flat portion to prevent unintended interference with the traversing element.
136. The stent apparatus according to any one of claims 124-134, wherein the surface has a gradually curved arched portion to prevent unintended interference with the traversing element.
137. The stent apparatus of claim 136, wherein the gradually curved portion has a radius of curvature larger than a radius of the traversing element.
138. The stent apparatus according to any one of claims 124-137, wherein the support member is configured to reduce the unsupported arc length of the traversing element by at least half compared to without the support member.GrowIP No. KELL-23-001-WO139. The stent apparatus according to any one of claims 124-138, wherein the traversing element is a guidewire, a catheter, a sheath system, or other therapeutic device.
140. The stent apparatus according to any one of claims 124-139, wherein the stent has an expandable metal frame covered by a graft material.
141. The stent apparatus according to any one of claims 124-140, wherein the support member is coupled to opposing sides of the main body.
142. The stent apparatus according to any one of claims 124-141, wherein the main body includes a first bifurcation separating the primary conduit into two secondary branches defining a first conduit and a second conduit, and wherein the traversing element is configured to be introduced into the second conduit and is deflected into the first conduit.
143. The stent apparatus of claim 142, wherein the support member is coupled to the first bifurcation.
144. The stent apparatus according to any one of claims 124-143, further comprising a second bifurcation separating the first conduit into two tertiary branches defining a third conduit and a fourth conduit.