Endovascular interface for adaptive optic nerve stimulation and associated systems and methods

Abstract

Implantable stimulation systems for providing stimulation to an optic nerve of a patient, and associated systems and methods, are disclosed herein. In some embodiments, the implantable stimulation system includes a stimulation generator and an electrode stent that can be positioned at a target site within an ophthalmic vein of the patient adjacent to the optic nerve. The electrode stent can include a main stent body extending from a proximal end region to a distal end region, a plurality of electrodes carried by the main stent body and distributed between the proximal end region and the distal end region, and a connector electrically coupled to each of the plurality of electrodes. The main stent body can be actionable between a collapsed configuration and an expanded configuration. The connector can include an individual connection lead for each electrode in the plurality of electrodes, thereby allowing the electrodes to be independently addressable.

Description

P333363.WO.01 (AE8O33)ENDOVASCULAR INTERFACE FOR ADAPTIVE OPTIC NERVE STIMULATION AND ASSOCIATED SYSTEMS AND METHODSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Patent Application No.63 / 791,077, filed April 18, 2025, the disclosure of which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology' is generally directed to an implantable electrode assembly for stimulating a patient's brain, and more specifically to an endovascularly delivered electrode assembly for stimulating an optic nerve in the patient’s brain to treat vision disorders.BACKGROUND

[0003] Optic neuropathies cause progressive vision loss in millions. For example, glaucoma can damage the optic nerve. Because retinal neurons are generally unable to regenerate, the damage can reduce the eye’s ability to communicate with the brain. While stem cells can in principle be used to produce new neurons, it is difficult to get the new neurons to form connections with the brain. Optic nerve stimulation is currently being researched as an approach to help restore vision in patients with blindness due to retinal degeneration, optic neuropathies, or other causes. For example, stimulation can be delivered from a non-invasive device or a set of electrodes surgically implanted onto the optic nerve during an open brain surgery. The stimulation, in turn, can help generate new' neurons to restore and / or maintain a patient’s sight; build, restore, and / or maintain neural pathways; and / or help reduce noise in existing neural pathways. However, non-invasive approaches are associated with suboptimal efficiencies due to the distance between the source of stimulation and the optic nerve, while invasive electrodes are associated w ith substantial procedural risks. Accordingly, further solutions are needed to help treat vision disorders.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Many aspects of the present disclosure can be better understood w ith reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure. The drawings-1- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) should not be taken to limit the disclosure to the specific embodiments depicted but are for explanation and understanding only.

[0005] Fig. 1 is a block diagram of a system for treating vision disorders configured in accordance with some embodiments of the present technology.

[0006] Fig. 2A is a sagittal view of a human head illustrating the anatomy of the superior ophthalmic vein and the optic nerve.

[0007] Fig. 2B illustrates additional features of the anatomy of the superior ophthalmic vein and a human skull.

[0008] Figs. 3A-3C are partially schematic diagrams of a helical structure for an electrode stent configured in accordance with embodiments of the present technology.

[0009] Fig. 4 is a partially schematic diagram of an electrode stent configured in accordance with further embodiments of the present technology7.

[0010] Figs. 5A-5C are partially schematic diagrams of an electrode stent configured in accordance with embodiments of the present technology'.

[0011] Figs. 6A and 6B are isometric views illustrating additional details of a body of an electrode stent in accordance with embodiments of the present technology7.

[0012] Fig. 7 is a partially schematic diagram of an electrode stent implanted in a vein of a patient in accordance with embodiments of the present technology.

[0013] Fig. 8 is a partially schematic diagram of an electrode stent implanted in a vein of a patient in accordance with further embodiments of the present technology.

[0014] Figs. 9A-9D are partially schematic diagrams illustrating an endovascular implantation of an electrode stent in accordance with embodiments of the present technology7.

[0015] Fig. 10 is a flow diagram of a process for implanting an electrode stent in accordance with embodiments of the present technology.

[0016] Figs. 11 A and 1 IB are partially schematic diagrams illustrating additional details on an endovascular procedure in accordance with embodiments of the present technology.

[0017] Fig. 12 is a flow diagram of a process for evolving stimulation parameters for an electrode stent in accordance with embodiments of the present technology.526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33)

[0018] Fig. 13 is a partially schematic diagram of a system for treating vision disorders configured in accordance with further embodiments of the present technology.

[0019] Fig. 14 is a partially schematic diagram of a system for treating vision disorders configured in accordance with further embodiments of the present technology.DETAILED DESCRIPTIONOverview

[0020] Implantable electrode systems and associated systems and methods are disclosed herein. For example, as discussed in more detail below, the electrode systems disclosed herein can include an endovascularly implantable stent assembly and a pulse generator. The stent assemblies can include an expandable main body (e.g., a single, continuous wire wound in a spiral configuration; a dual-layer braided structure; a shape-memory material, and / or the like) and a plurality of electrodes carried by the main body. The plurality of electrodes can include stimulating electrodes and recording electrodes. The stimulating electrodes deliver electrical stimulation to the optic nerve. The recording electrodes detect electrical activity from the optic nerve (e.g., in response to the stimulation and / or monitoring activity over time).

[0021] The pulse generator (e.g., an implantable pulse generator (IPG)) provides the stent assembly with electrode stimulation patterns. The IPG can be positioned beneath the patient’s skin on the anterior chest wall. In such embodiments, the IPG is tunneled to the patient’s chest wall and connected to the stent assembly through a venous access path. The IPG can have an onboard microprocessor and rechargeable battery. The microprocessor can enable artificial intelligence and / or deep learning adaptable stimulation programs (via onboard processing and / or communication with remote computing devices) based on recorded neural impulses and responses. As a result, the stimulation delivered by the stimulating electrodes can evolve over time (e.g., based on an assessment of the recorded electrical activity, changes in a patient’s condition, and / or the like).

[0022] As further discussed in more detail below, the stent assemblies disclosed herein can be implanted into a patient’s superior ophthalmic vein via the patient’s common jugular vein in an endovascular procedure. The ophthalmic veins, especially the superior ophthalmic vein, run in close proximity to the optic nerve. As a result, they provide an endovascularly accessible point for the stent assemblies to receive electrical signals and deliver electrical stimulation to the optic nerve. The position within the ophthalmic veins allows the stent assemblies to be significantly-3- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) more effective than non-invasive stimulation devices while the endovascular delivery allows the delivery process to significantly reduce the risks associated with delivering the electrode stents. In various embodiments, as discussed in more detail below, the stent assemblies disclosed herein can be positioned within the superior ophthalmic vein, the inferior ophthalmic vein, and / or the anterior portion of the cavernous sinus. The selection of the target site can be based on the patient's specific anatomy, the location of the optic nerve damage or degeneration, and / or the accessibility’ of the vascular structure during the endovascular procedure.

[0023] Additional details on various aspects of the technology are set out below. In the following description, specific details are set forth to provide a thorough understanding of aspects of the present technology. One skilled in the relevant art will recognize, however, that the systems, devices, and techniques described herein can be practiced without one or more of the specific details set forth herein or with other methods, components, materials, etc. For example, one of skill in the art will understand that the technology disclosed herein is not limited to the specific arrangements and parameters of electrode stents that are illustrated and discussed herein. In a specific, non-limiting example, subject to the express considerations set out below, a stent assembly of the type disclosed herein can include various other types of expandable bodies and / or various other arrangements of electrodes on the expandable bodies. As another example, although the stent assemblies are frequently discussed with respect to specific vision disorders, one of skill in the art will understand that the technology7disclosed herein can be used to help treat a wide variety of other vision disorders and / or other optic pathologies. As yet another example, although the stent assemblies are disclosed herein as being endovascularly delivered through the common jugular vein, one of skill in the art will understand that the stent assemblies can be delivered through various other suitable veins to provide effective access to the ophthalmic veins.

[0024] Reference throughout this specification to an “example” or an “embodiment” means that a particular feature, structure, or characteristic described in connection with the example or embodiment is included in at least one example or embodiment of the present technology. Thus, the use of the phrases “for example,” “as an example,” “in one embodiment.” or “an embodiment” herein are not necessarily all referring to the same example or embodiment and are not necessarily limited to the specific example or embodiment discussed. Furthermore, features, structures, or characteristics of the present technology7described herein may be combined in any suitable manner to provide further examples or embodiments of the present technology.-4- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33)

[0025] Spatially relative terms (e g., “beneath,” “below,” “over,” “under,” “above,” “upper.” “top,” “bottom,” “left,” “right,” “center,” “middle.” and the like) may be used herein for ease of description to describe one element’s or feature’s relationship relative to one or more other elements or features, as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of a device or system in use or operation, in addition to the orientation depicted in the figures. For example, if a device or system illustrated in the figures is rotated, turned, or flipped about a horizontal axis, elements or features described as “below” or “beneath” or “under” one or more other elements or features may then be oriented “above” the one or more other elements or features. Thus, the terms “below” and “under” are nonlimiting and can encompass both an orientation of above and below. The device or system may additionally, or alternatively, be otherwise oriented (e.g.. rotated ninety degrees about a vertical axis, or at other orientations) than illustrated in the figures, and the spatially relative descriptors used herein are interpreted accordingly. In addition, it will also be understood that when an element is referred to as being “between” two other elements, it can be the only element between the two other elements, or one or more intervening elements may also be present.

[0026] It should also be noted that the terms “proximal” and “distal” as used herein, are intended to refer to a direction toward (proximal) and away from (distal) a surgeon or other user. Furthermore, the term electrical signal, as used herein, may include, for example, electrical impulses and signals with time-varying degrees of voltage, current, frequency, pulse duration, and / or wavelength.Introduction

[0027] Blinding optic neuropathies such as non-arteritic anterior ischemic optic neuropathy (NAION), glaucoma, ischemic optic neuropathy, traumatic optic neuropathy, optic neuritis, and / or dominant optic atrophy affect millions of people worldwide. These conditions can cause vision loss due to optic nene damage or degeneration, but currently have limited or no effective treatments — there is a lack of adequate interventions to help prevent and / or reverse disease progression available for patients. Recently, optic nerve stimulation has shown promise for treatment and / or vision restoration. For example, results from non-invasive techniques like repetitive transorbital alternating current stimulation (rtACS) have show n efficacy in restoring or preserving vision, particularly for pre-chiasmatic lesions, such as optic neuropathies. However, the results from the non-invasive techniques have shown to have a limit in their efficacy. For example, non-invasive approaches are limited by poor spatial resolution, high activation-5- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) thresholds, and inconsistent phosphene generation due to the distance between the electrodes and the optic nerve. Meanwhile, invasive approaches such as direct optic nerve or cortical implants carry substantial procedural risks, including nerve damage, cerebrospinal fluid leak, and intracranial complications. Fig. 14 is a partially schematic diagram of an example of a non-invasive system for treating vision disorders. In this example, the Argus II epiretinal prosthesis uses a 60-electrode array placed on the retina to stimulate retinal ganglion cells (RGCs). While it has enabled light perception and basic object localization in some patients, the Argus II suffers from several limitations: high stimulation thresholds, spatial distortion due to unintended axonal activation, a narrow field of view, fixed open-loop programming, and relatively low long-term visual acuity (-20 / 1600 at best). Additionally, ocular complications such as conjunctival erosion, hypotony, and endophthalmitis have been reported in a significant subset of patients. These shortcomings have led to developments in fully invasive electrode implantation on the optic nerve. While direct implantation can increase the stimulation delivered to the optic nerve and increase the efficacy of the stimulation, the invasive surgery required to implant an electrode is associated with significant risks to the patient.

[0028] Instead, the systems and methods disclosed herein provide an endovascular approach to delivering an electrode stent in close proximity to the optic nerve. This new class of endovascular neural interfaces — such as electrode stents delivered through the superior ophthalmic vein — offers a minimally invasive alternative that avoids direct manipulation of the optic nene or retina. More specifically, the systems and methods disclosed herein deliver an electrode stent (sometimes also referred to herein as a "‘stent assembly ’ a “stent,” an “endovascular electrode device,” and / or the like) to a patient’s ophthalmic veins via the patient’s jugular vein, and couple the electrode stent to a stimulation generator and / or one or more remote computing devices. The electrode stents can be positioned within venous structures adjacent to the optic nerve, enabling lower threshold stimulation of RGC axons across a broader visual field. Unlike traditional prostheses, these systems can integrate both stimulating and recording electrodes, enabling closed-loop, adaptive control of stimulation parameters using machine learning algorithms responsive to real-time neural activity. This approach not only reduces procedural risks but also holds the potential to deliver more precise, stable, and personalized visual percepts. Accordingly, there is a need for safer and more effective solutions — such as endovascular, feedback-driven optic nen e stimulation systems — to address the limitations of current vision restoration technologies.-6- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33)

[0029] For example, Fig. 1 is a block diagram of a system 100 for treating vision disorders of a patient 10 configured in accordance with some embodiments of the present technology. As illustrated in FIG. 1, the system 100 can include a stimulation system 110 that includes a stent stimulation component 112 (e.g., an electrode stent) and a stimulation generation component 114 (e.g., an IPG) operably coupled to the stent stimulation component 112. As discussed in more detail below, the stent stimulation component 112 can include a main body and one or more electrodes carried by the main body. The stent stimulation component 112 can be endovascularly implanted into a vein in the patient’s brain adjacent to the optic nerve (e.g., any of the ophthalmic veins, such as the superior ophthalmic vein), allowing the stent stimulation component 112 to deliver electrical stimulation to the optic nerve. The stimulation generation component 114 (sometimes also referred to herein as a "therapy subsystem,” a “learning subsystem,” a “rehabilitation subsystem,” a “training subsystem,” and / or the like) can administer various trials to the patient 10 that are related to treating various injuries, disorders, and / or diseases. The stimulation generation component 114 can also receive measurements from the stent stimulation component 112 related to the response from the optic nerve in patient 10 to the stimulation. The stimulation generation component 114 (or another suitable device, such as a patient user device 120 (e.g., a smartphone, tablet, personal computer, and / or the like), a medical user device 130, and / or a cloud computing device coupled to the stimulation generation component 114) can then evaluate the measured responses to determine the efficacy of the stimulation treatment, identify one or more tweaks to the treatment to help improve efficacy, monitor activity in the optic nerve to track disease progression and / or rehabilitation progress, and / or the like.

[0030] As discussed above, the electrode stent can be delivered to the ophthalmic veins of a patient. Fig. 2A is a sagittal view of a human head illustrating the anatomy of the superior ophthalmic vein and the optic nene. This sagittal view of the human head in Fig. 2A includes an orbit containing an eye, an optic nerve extending from the back of the eye towards a brain, a cavernous sinus, and a superior ophthalmic vein extending from the orbit to the cavernous sinus. In the illustrated example, the superior ophthalmic vein crosses over the optic nerve, which is believed to occur in about 87% of humans in the right orbit and about 71% of humans in the left orbit. As a result, despite differences in vein anatomy between patients, the superior ophthalmic vein will often provide a valuable target vein to endovascularly deliver an electrode stent to and to provide electrical stimulation from. Fig. 2A also illustrates a mean diameter and cross-section of the optic nerve, a mean distance to the optic nerve and a superior ophthalmic vein wall thickness, and a mean outer diameter of the superior ophthalmic vein at the crossing point. The-7- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) mean outer diameter at the crossing point has been found to be about 1.7 millimeters (mm) (with a range between about 0.4mm to about 4.6 mm) in the right orbit and 1.7 mm (with a range between about 0.4mm to about 4.6 mm) in the left orbit, which provides a relatively strong baseline for a target size for the electrode stent.

[0031] Fig. 2A also depicts a variety of cell types and characteristics between the optic nerve and the superior ophthalmic vein. These tissues would affect the electrical properties and current flow between the optic nerve and the superior ophthalmic vein. For example, Fig. 2A illustrates: (a) dura mater (the outermost layer of the meninges covering the optic nerve), (b) arachnoid mater (the middle layer of the meninges, (c) pia mater (the innermost layer of the meninges, directly covering the optic nerve, (d) cerebrospinal fluid (found in the subarachnoid space), (e) connective tissue (including collagen, elastin fibers, and adipose tissue or fat), and (f) blood vessels (small arterioles and venules supplying the nerve and surrounding tissues). Fig. 2A also indicates various potential placement sites for the electrode stent in the superior ophthalmic vein and / or the anterior portion of the cavernous sinus, demonstrating their proximity to the optic nerve.

[0032] Fig. 2B illustrates additional features of the anatomy of the superior ophthalmic vein and a human skull. More specifically, Fig. 2B illustrates the left orbit (a-c) and dried skull (d) demonstrating the intraconal portion of the superior ophthalmic vein coursing below the superior rectus muscle on the medial to lateral aspect and crossing over the optic sheath (arrows in a and b), the extraconal segment at the orbital apex coursing between the superior rectus muscle and lateral rectus muscle toward the superior orbital fissure (arrow in c), and the intracranial extraorbital portion emerging from the superolateral part of the superior orbital fissure connecting to the superolateral portion of the cavernous sinus.

[0033] As illustrated in Figs. 2A and 2B, the ophthalmic veins, especially the superior ophthalmic vein, typically run in close proximity to the optic nerve. As a result, when the electrode stent is positioned within the superior ophthalmic vein, the electrode stent can better deliver stimulation compared to a non-invasive technique. Further, while the endovascular delivery' of the electrode stent requires careful mapping and navigation of vein anatomy, the endovascular delivery is associated with fewer risks to the patient than delivering an electrode stent to the optic nerve directly (e.g., via an operation on the patient’s brain). That is, the systems and methods disclosed herein can provide the benefits of invasive electrode placement while helping mitigate the risks of a procedure to provide invasive treatment. Still further, as discussed in more detail-8- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) below, the electrode stents can include features to help securely fix the electrode stent in place. Additionally, or alternatively, the electrode stents can include patterns of electrodes that allow the electrode stent to deliver stimulation to the optic nerve irrespective of orientation after endovascular placement (e.g., alleviating difficulties with precise placement). Additionally, or alternatively, the patterns of electrodes can allow the electrode stent to deliver varying patterns of stimulation (e.g., to help improve an efficacy of the stimulation). For example, by integrating brain-computer interface technology, the systems described herein enable real-time, adaptive control of stimulation parameters, providing more precise and personalized treatment.

[0034] In some embodiments, the electrode stents include a self-expanding stent body that includes a single, continuous wire extending from a proximal end region to a distal end region of the electrode stent. The wire can be made from a biocompatible, superelastic material (e.g., nitinol) that is wound in a spiral configuration with a series of loops and turns. As a result, the wire defines an open-cell structure. The stent body can have an expanded diameter between about 1.5 mm and about 2.0 mm, making the expanded stent body suitable for implantation in the superior ophthalmic vein and / or an anterior portion of a cavernous sinus. In this embodiment, the electrode stent can include a plurality of electrodes that are distinct entities placed on each helix of the stent structure. Each of the electrodes can be connected to a corresponding helix by a single connector, allowing for independent positioning and functioning (e.g., to independently deliver stimulation and / or record neutral activity). In various embodiments, the electrode stent can be configured based on patient-specific venous anatomy. For example, given variation in size of the target vascular structure between patients, the electrode stent can be selected from a plurality of available configurations (e.g., different diameters, lengths, and / or electrode arrangements) to match the patient's specific anatomy. Additionally, or alternatively, the electrode stent can be custom-manufactured based on imaging data of the patient's venous system.

[0035] In some embodiments, the electrode stents include a braided stent design with a duallayer structure. The inner layer can be more densely braided than the outer layer. The inner layer and the outer layer can both be made from biocompatible materials (e.g., nitinol). The dual-layer braided design can help increase a flexibility of the electrode stent, allowing the electrode stent to conform to tortuous cerebral vessel anatomy and / or helping enable precise endovascular deployment via a microcatheter. In such embodiments, the electrode stent can include a plurality of electrodes integrated with a secondary layer between the inner layer and the outer layer. The secondary layer can include a separate spiral wire that runs alongside the main stent structure and carries the plurality of electrodes. The spiral electrode wire is distinct from the structural -9- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) components of the inner and outer layers, allowing the electrode stent to deliver targeted stimulation via the electrodes without compromising the electrode stent's mechanical properties.

[0036] In each of the embodiments discussed above, the electrode stents can include one or more stimulating electrodes facing outwardly with respect to a central axis of the main body of the electrode stent. As a result, at least a portion of the electrodes face the optic nerve after the electrode stent is implanted. The electrodes can include a stable, low-impedance material (e.g., platinum, platinum-iridium alloy, and / or a conductive polymer). In various embodiments, the electrodes can include cylindrical ring electrodes, segmented electrodes for selective stimulation and recording, and / or various other types of electrodes. Further, the spiral dispersion of the electrodes in both designs can increase the overall surface area of the electrodes, which can help improve stimulation efficiency and allow for more precise targeting of the optic nerve.

[0037] Additionally, each of the embodiments of the electrode stents discussed above can include one or more recording electrodes integrated into their respective electrode systems. The recording electrodes can record and / or help monitor neural activity from different segments of the optic nerve. As a result, the systems and methods disclosed herein can identify regions of the optic nerve that exhibit reduced or abnormal firing patterns, indicating potential injury or degeneration. Additionally, or alternatively, the systems and methods disclosed herein can evolve the parameters for the stimulating electrodes over time and identify patterns that increase treatment efficacy from the stimulation. For example, systems disclosed herein can include an implantable pulse generator (IPG) operatively coupled to the electrode stent. The IPG can be positioned in a periauricular area (specifically in the retro-auricular space) of the patient’s body and provides continuous or programmable stimulation over an extended period. The stimulation can be delivered via precise patterns of electrical pulses through the stimulating electrodes to modulate optic nerve activity, thereby allowing for flexible and targeted stimulation of specific optic nerve regions. Over time, the IPG can adjust stimulation parameters using a machine learning model (onboard and / or in response to instructions from a remote computing device). In some embodiments, the machine learning model incorporates simulations based on the Hodgkin-Huxley equations for nerve fiber bundle stimulation. The Hodgkin-Huxley -based model can process physiological signals from the recording electrodes (e g., electrically evoked potentials or optic nerve activity) and adjust the stimulation parameters in real time using a closed-loop control system. The model aims to activate optic nerve axons and optimize therapeutic effects while avoiding tissue damage.-10- 526600'00016\4925-4039-4402\1

[0038] As a result, the systems and methods using the endovascular approach disclosed herein can help enable safe, precise, and effective optic nerve stimulation to help slow, halt, and / or reverse the progression of vision loss in optic neuropathies. Additionally, or alternatively, the systems and methods disclosed herein can help identify injured or degenerating segments of the optic nerve (e.g., based on abnormal neural activity patterns) and deliver targeted stimulation and / or communicate diagnoses to help enable additional treatments. As a result, the systems and methods disclosed herein have the potential to help a wide range of patients with previously untreatable forms of vision loss or impairment.

[0039] Additional details on examples of the electrode stent and the stimulation systems more generally, as well as various processes implemented by the stimulation system (and computing components coupled thereto) are discussed below.Examples of Suitable Electrode Stents and Related Systems and Methods Configured in Accordance with Embodiments of the Present Technology

[0040] The designs for electrode stents, electrodes carried by stents, stimulation generators, and associated systems disclosed herein aim to help provide long-term stability and effective treatment of optic neuropathies. For example, electrical stimulation can help: provide neuroprotection, thereby helping promote the survival of injured neurons; promote neuroregeneration by helping enhance axonal regeneration and / or sprouting; improve neuroplasticity, for example by modulating synaptic connectivity in visual pathways; provide various vascular benefits, such as increased blood flow and / or oxygenation; promote immunomodulation, for example by reducing inflammatory responses; and / or the like. As a result, electrical stimulation treatments are expected to help preserve remaining nerve fibers, slow disease progression, and potentially improve visual function in patients with optic neuropathies. Further, the placement and design of the electrode stents, electrodes carried by stents, stimulation generators, and associated systems disclosed herein aim to help improve the overall efficacy of treatments for preserving and / or restoring vision in patients with optic neuropathies. For example, by delivering stimulation to the optic nerve from adjacent veins, the electrode stents disclosed herein have the potential to offer more sustained and targeted therapy compared to external stimulation methods.

[0041] In some of the embodiments disclosed herein, a single, insulated conductor runs along the length of the stent, connecting each electrode to a contact near a proximal end of the stent. The conductor can be made of a highly conductive, fatigue-resistant material (e g., DFT® wire) and is insulated with a thin coating of ethylene tetrafluoroethylene (ETFE) or similar-11- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) polymer. The conductor can be laser welded and / or otherwise bonded to each electrode in a way that reduces (or minimizes) mechanical stress and electrical resistance.

[0042] At the proximal end of each stent body, the conductor transitions to a flexible lead body via a hermetic junction. The lead body can have a diameter of less than about 1.5 mm. or less than about 1 mm, to facilitate safe navigation through the narrow and tortuous vasculature of the venous system. The lead body contains individually insulated wires that extend from the hermetic junction to a proximal end of the lead body that is operably couplable to a stimulation generator (e.g., an IPG component positioned in the patient’s chest, in a sub-clavicular pocket, positioned behind a patient’s ear, and / or the like). More specifically, the insulated wires in the lead body operably couple the conductor from the stent to a set of terminal contacts at the proximal end of the lead body. In turn, the terminal contacts are operably couplable to the stimulation component. For example, the terminal contacts can be designed to plug into the IPG component. When coupled, the stimulation component can supply stimulation pulses to one or more of the electrodes and / or receive recorded signals from one or more of the electrodes.

[0043] Each of the electrode stents disclosed herein can include a main stent body that is coated with a durable, biocompatible polymer (e.g., phosphorylcholine, fluoropolymer, and / or the like). The polymer coating encapsulates the main stent body, any stent wire, the conductor, and at least a portion of the electrodes. As a result, the polymer coating can provide electrical insulation and / or enhance the structural integrity of the electrode stent. In various embodiments, the polymer coating can include various additional agents such as anti-inflammatory drugs, antithrombotic drugs, and / or neurotrophic factors that work synergistically to improve biocompatibility and promote optic nerve health. Additionally, or alternatively, the polymer coating can include radiopaque or echogenic particles to help enhance a visibility of the electrode stent during and / or after delivery. In some embodiments, the electrode stents (e.g., in the main stent body and / or the stent wire) include radiopaque markers to enhance visibility under fluoroscopy or x-ray. In various embodiments, the radiopaque markers can be positioned at the proximal and / or distal end of the main stent body, and / or interspersed along the main stent body. The radiopaque markers can include tantalum, platinum, and / or another suitable radiopaque material. Further, the radiopaque markers can be fused, swaged, and / or otherwise incorporated into the electrode stents.

[0044] Further, the electrode stents disclosed herein are designed to be delivered endovascularly to a target site adjacent to the optic nerve (e.g., an identified position within an ophthalmic vein) using percutaneous catheter-based techniques. For example, the electrode stents-12- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) can be actionable between a collapsed configuration and an expanded configuration. Purely by way of example, as discussed in more detail below, the main body of the electrode stents can have a spiral and / or braided structure that allows the main body of the electrode stents to be radially compressed without buckling or fracture, and then to self-expand when deployed.

[0045] In the collapsed configuration, the electrode stents have an outer diameter that can be contained within a delivery catheter with an inner diameter of less than about 2 mm, or less than about 1.5 mm. In some embodiments, the electrode stent is delivered through a 0.017-inch microcatheter (e.g., having a diameter between about 0.25 mm and about 0.75 mm). In various embodiments, the catheter, microcatheter, and / or the electrode stent can be laser cut and braided using a drawn filled tube (DFT) system, which can help provide both structural integrity and electrical conductivity for the electrode stent. The electrode stents can be loaded into a delivery catheter in the compressed state and advanced over a guidewire through the venous vasculature to the target site (e.g., a position within the superior ophthalmic vein and / or cavernous sinus). Once positioned at the target site, the electrode stent can be deployed by pushing the stent out of the delivery catheter and / or by retracting the delivery catheter and allowing the stent body to selfexpand into contact with the vessel wall. Once deployed, at least a portion of the electrodes on the electrode stent are oriented towards the optic nerve, thereby allowing the electrode stent to provide selective stimulation and / or record activity in the optic nerve.

[0046] In some embodiments, the electrode stent and / or the delivery catheter includes one or more steering mechanisms to facilitate navigation through the tortuous venous anatomy. The steering mechanisms can include, for example, pull wires, deflectable catheter tips, and / or shapememory components that allow- a clinician to guide the electrode stent through the vascular pathways to the target site. The steering mechanisms can help improve the precision of electrode stent placement adjacent to the optic nerve.

[0047] In some embodiments, a distal end region of the electrode stent and / or the lead body includes a pre-shaped cune configured to facilitate optimal placement of the electrodes adjacent to the optic nen e. The pre-shaped cun e can help direct the stimulating electrodes and / or recording electrodes toward the optic nerve when the distal end region is positioned in the superior ophthalmic vein. The pre-shaped curve can be formed from a shape-memory material (e.g., nitinol) that retains the curved configuration after deployment.

[0048] Various embodiments of the electrode stents disclosed herein (e.g., a single-wire spiral design for the main stent body, the braided design for the stent body, and / or the like) can-13- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) offer several advantages over traditional mesh stents and / or multi-filament devices for the specific use of providing stimulation to the optic nerve from an adjacent vascular structure. For example, the open-cell and dual-layer structures disclosed herein can allow greater flexibility and conformability, enabling the electrode stents to be delivered through and / or adapt to the tortuous anatomy of the ophthalmic veins and / or cavernous sinus. Additionally, or alternatively, the electrode stent designs disclosed herein can help reduce the risk of thrombosis and / or restenosis by reducing (or minimizing) strut thickness and helping avoid overlap at junctions.

[0049] Once the electrode stent is deployed, the lead body is positioned to extend proximally through the venous vasculature and then is tunneled subcutaneously to a pocket (e.g., an IPG pocket) in a patient’s periauricular area and / or a subcutaneous pocket in the patient’s chest (e.g., over a pectoralis muscle). The proximal terminal contacts of the lead body can then be plugged into the stimulation generator to complete a circuit with the electrodes in the electrode stent. In some embodiments, the main stent body (or a portion thereof) is detachable from the lead body. For example, the electrode stent can include a detachable coupling mechanism that allows the main stent body to be separated from the lead body after deployment, allowing the lead body to be retracted after the main stent body is deployed. In such embodiments, the detached main stent body can communicate wirelessly with the stimulation generator and / or can be coupled to a replacement lead component.

[0050] The stimulation generator (e.g., an IPG and / or other suitable device) is a sophisticated device that integrates several advanced features to help optimize therapy and enhance patient care. For example, the stimulation generator can include a programmable microprocessor that controls the stimulation parameters of the electrode stents and enables (or implements) an adaptive algorithm (e.g., a responsive algorithm, a machine learning algorithm, and / or the like) for continuous therapy optimization. The adaptive algorithm can adapt stimulation protocols based on data collected from recording electrodes in the electrode stent indicative of the patient's response to the stimulation, updates on the status of the optic neuropathies, and / or the like. As a result, the stimulation generator can provide a personalized and evolving treatment.

[0051] In some embodiments, the stimulation generator includes wireless communication capabilities that facilitate remote management and / or allow the stimulation generator to interface with an external computing device. The external communication can enable clinicians (e.g., via the medical user device 130 of Fig. 1) to remotely monitor patient progress (e.g., by viewing the data collected from recording electrodes in the electrode stent), make real-time adjustments to-14- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) stimulation settings, and / or download new stimulation protocols into the stimulation generator without additional surgical procedures. Relatedly. the external communication can allow the stimulation generator to communicate with a peripheral computing device (e.g., the patient user device 120 of Fig. 1) to implement at least a portion of the adaptive algorithm. In a specific, nonlimiting example, the adaptive algorithm can include a machine learning and / or other artificial intelligence algorithm. In such embodiments, the stimulation generator can communicate data from the recording electrodes in the electrode stent to the peripheral device, allowing the peripheral device to implement the machine learning algorithm. Implementing the machine learning algorithm on a peripheral device can help reduce the amount of processing power required within the stimulation generator to implement the machine learning aspects of the adaptive algorithm.

[0052] The stimulation generator can be powered by a battery. In some embodiments, the battery is periodically replaceable. The replacement, however, can require surgical operations. In some embodiments, the battery is rechargeable. For example, an implanted stimulation generator can be inductively chargeable through the patient’s skin, eliminating the need for periodic surgical replacements and reducing the long-term invasiveness of the therapy. In another example, a periauricular implant can be chargeable through one or more access points external to the patient’s body. The charging process can be designed to be convenient and comfortable for the patient, further enhancing the overall treatment experience and long-term viability of the system.

[0053] In some embodiments, the stent-based neural interface system includes an integrated or modular power supply (referred to collectively as an “embedded power source”) configured to support electrical stimulation and / or signal acquisition functions. The embedded power source can include a miniaturized battery and / or other suitable energy storage unit positioned directly on the stent scaffold or within adjacent vascular structures adjacent to the stent. The embedded power source can be structurally secured using biocompatible anchoring mechanisms and electrically connected to the electrode assembly via micro-scale conductive traces or flexible interconnects.

[0054] The embedded power source can be operable in conjunction with wireless communication circuitry designed to interface with an external or implantable pulse generator (IPG) or control module. Wireless transmission may occur via inductive coupling, near-field communication (NFC), radiofrequency (RF) telemetry, or other biocompatible communication protocols. Such a configuration allows for remote control of stimulation parameters, bidirectional data transfer, and system diagnostics, without the need for transcutaneous leads or permanent-15- 526600'00016\4925-4039-4402\1wired connections. In some embodiments, the embedded power source can include a local control unit that can communicate with a remote IPG and / or other control module intermittently and otherwise control stimulation parameters for the electrode stent. In such embodiments, the electrode stent can operate in an autonomous and / or semi-autonomous mode between communications.

[0055] In some implementations, the embedded power source can include energy harvesting components that convert physiological forces into electrical energy. These components can include (but are not limited to) flow-sensitive microturbines, piezoelectric elements responsive to pulsatile blood flow, or electromagnetic harvesters utilizing vascular motion. This configuration may supplement or replace traditional recharging approaches, enabling autonomous or semi-autonomous operation over extended durations.

[0056] All electronic and energy' storage components may be encapsulated in a hermetically sealed, biocompatible housing composed of materials such as titanium, parylene-coated polymers, or flexible silicone composites. The encapsulation is designed to prevent fluid ingress, maintain device integrity under physiological pressure, and minimize thromboembolic or immunological responses.

[0057] Including the power and communication modules can help provide critical advantages to the stimulation systems disclosed herein in certain clinical scenarios. For example, the power and communication modules can help adapt the stimulation system where a fully implantable, leadless system is desired and / or where continuous wireless communication and dynamic stimulation control are necessary for therapeutic efficacy. Accordingly, the integration of a battery -powered, wirelessly' connected module is considered within the scope of the present invention.

[0058] In various embodiments, the stimulation generator can include a variety of structural design features to help provide effective stimulation control while improving patient experience with the stimulation device. For example, in embodiments that include a periauricular IPG, the periauricular can be designed to optimize fit and function via one or more of the following: a curved shell design (e.g., athin, curved shell that conforms to natural contours behind the patient’s ear, minimizing protrusion and reducing the risk of displacement during daily activities); a modular design (e.g.. a system composed of smaller, interconnected modules that can be arranged to best fit the patient’s individual anatomy, which is expected to help provide a more customized and comfortable fit); a flexible substrate design (e.g., an IPG built on a flexible substrate that can-16- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) adapt to the curvature of the skull and movements of the periauricular area, thereby reducing stress on surrounding tissues); a low-profile disc design (e.g., a compact, disc-shaped IPG with a low profile to reduce (or minimize) visibility and reduce the risk of trauma from accidental impacts); an anchored design (e.g., an IPG with a small anchoring system that secures the IPG to the temporal bone, thereby reducing (or preventing) migration while providing some flexibility to accommodate head and neck movements). Each of the design considerations above is expected to help create an IPG that provides effective stimulation control, as well as help increase patient comfort, help improve aesthetics, and help provide long-term stability in the periauricular area.

[0059] Figs. 3A-3C are partially schematic diagrams of a helical structure for an electrode stent 300 configured in accordance with embodiments of the present technology. In the illustrated embodiments, the electrode stent 300 is a cylindrical metallic stent having a main body 310 that has a consistent waxy helical structure. The helical structure of the electrode stent 300 can be designed for neuromodulation therapy targeting the superior and / or inferior ophthalmic veins, and / or the anterior cavernous sinus. For example, the electrode stent 300 can have a diameter, when in an expanded state, of between about 1 mm and about 1.5 mm, which is suitable for the relatively small vascular pathways. Further, as best illustrated in Fig. 3C, the electrode stent 300 can include first and second electrodes 312, 314 that are strategically placed along the main body 310 to maximize stimulation coverage.

[0060] The first and second electrodes 312, 314 are operably coupled to a cable 320 with one or more communication channels. The cable 320, in turn, can extend through the patient’s venous system (e.g., via the jugular vein) and is operably coupled to a stimulation generation component (e.g., an implantable pulse generator (IPG) in the patient’s chest). As a result, the cable 320 allows the stimulation generation component to individually (or collectively) deliver electric signals to the electrode stent 300. Conductive pathways are integrated within the electrode stent 300 (e.g., through the main body 310) using stretchable materials like liquid metal alloys, conductive polymers, and / or metallic nanowire networks, which maintain electrical function during the stent's expansion and adapt to natural vessel movements. These pathways are coated with biocompatible insulation to protect surrounding tissues from unintended electrical exposure and couple the first and second electrodes 312, 314 to the cable 320.

[0061] In the illustrated embodiment, the first electrodes 312 are helical electrodes positioned on the upper and lower parts of each helix, while the second electrodes 314 are rectangular electrodes positioned along the lateral sides of the main body 310. The positions of-17- 526600'00016\4925-4039-4402\1the first and second electrodes 312, 314 enable multi-directional electrical stimulation, allowing the electrode stent 300 to deliver stimulation to the optic nerve regardless of the orientation in which the electrode stent 300 is placed during endovascular delivery and / or irrespective of changes in patient anatomy over time.

[0062] As discussed in more detail below, the electrode stent 300 can be delivered using a balloon catheter 330, which expands the electrode stent 300 to match the vessel's diameter and helps ensure firm contact between the first and second electrodes 312, 314 and the vessel wall for efficient electrical delivery and stimulation of the optic nerve. Once the electrode stent 300 is securely positioned, the balloon catheter 330 can be deflated, and the catheter will be withdrawn, leaving the electrode stent 300 in place.

[0063] As further illustrated in Fig. 3C, the electrode stent 300 can include one or more anchors 340 (two illustrated in Fig. 3C) at a distal end region of the main body 310. The anchors 340 can attach to interior walls of the patient’s vein 301 to help secure the electrode stent 300 in position. Further, the anchors 340 can include a radiopaque material, thereby allowing the electrode stent 300 to be visible during various imaging processes to confirm proper placement and / or to image the electrode stent 300 during the endovascular deployment.

[0064] Fig. 4 is a partially schematic diagram of a mesh structure 410 for an electrode stent 400 configured in accordance with further embodiments of the present technology. In the illustrated embodiment, the mesh structure 410 is a dual -lay er braided structure that includes an inner layer and an outer layer. The inner layer is densely braided while the outer layer is loosely- braided (e.g., more loosely braided than the inner layer). The mesh structure 410 can be made from nitinol and / or any other suitable biocompatible material. As further illustrated in Fig. 4, the electrode stent 400 further includes a secondary layer 420 positioned between the inner layer and the outer layer of the mesh structure 410 and running along a longitudinal axis of the mesh structure 410. The secondary layer 420 includes a spiral wire 422 and a plurality of electrodes 424 carried by the spiral wire 422. Each of the electrodes 424 can be operably- coupled to one or more channels of a connector integrated with and / or carried by the spiral wire 422.

[0065] The architecture of the electrode stent 400 in Fig. 4 has several benefits. First, because the secondary layer 420 is separate from the mesh structure 410, the secondary layer 420 (and the electrodes 424 thereon) can be added to existing stents that include the mesh structure 410. Second, relatedly, the separation between the mesh structure 410 and the secondary' layer 420 can allow the electrode stent 400 to be more flexible during a surgical delivery process. Third, the-18- 526600'00016\4925-4039-4402\1spiral wire 422 can carry' a plurality of channels of the connector, thereby allowing each of the electrodes 424 to be independently addressable. As a result, for example, a first subset of the electrodes 424 can be employed to deliver stimulation to the patient while a second subset is used to measure a response (e.g., neural activity7in response to the stimulation). Further, which electrodes are in the first and second subsets can be varied over time to gradually evolve the stimulation that is delivered.

[0066] Figs. 5A-5C are partially schematic diagrams of an electrode stent 500 configured in accordance with embodiments of the present technology. For the sake of clarity, several components of the electrode stent 500 (e.g., a lead coupled to the electrode stent) are not illustrated in Figs. 5A-5C. However, one of skill in the art will understand that the electrode stent 500 can include various other components discussed here. In the illustrated embodiments, the electrode stent 500 includes a self-expanding body 510 formed from a single, continuous nitinol wire wound in a spiral configuration. The self-expanding body 510 has an open-cell structure that includes a plurality of rings connected by one or more connectors and / or an internal helical structure. Each of the rings (sometimes also referred to as helix structures) includes a plurality' of struts coupled together at crowns (e.g., elbow joints) between the struts. Further, as illustrated in Fig. 5A, the electrode stent 500 also includes a plurality of electrodes 512 each carried by a corresponding ring of the self-expanding body 510 and operably coupled to the one or more connectors. Similar to the discussion above, each of the connectors can include a plurality' of channels, alloyving each of the electrodes 512 to be independently addressable. The electrodes 512 are omitted from Figs. 5B and 5C to provide additional clarity on the architecture of the helix structure of the self-expanding body 510, as well as the physical relationship between the struts, the crowns, and the connectors.

[0067] Figs. 6A and 6B are isometric views illustrating additional details on examples of stent bodies for an electrode stent of the type discussed above with reference to Figs. 5A-5C. More specifically, Fig. 6A illustrates a straight-centerline stent 600 and Fig. 6B illustrates a helical-centerline stent 610, each of which can provide the self-expanding body 510 discussed above with reference to Figs. 5A-5C. An example of the straight-centerline stent 600 of Fig. 6A includes the LifeStent™ Vascular Biliary Stent from Becton Dickinson, which can then be modified to include the secondary layer and / or any other suitable layer with electrodes. An example of the helical-centerline stent 610 of Fig. 6B includes the BioMedics3D stent available from Very an Medical, which can then be modified to include the secondary layer and / or any other suitable layer with electrodes. In various embodiments, the straight-centerline stent 600 and / or the helical-centerline stent 610 can have a diameter (once expanded) between about 4 millimeters -19- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) (mm) and about 8 mm, or about 6 mm, allowing the electrode stent to easily fit into and / or conform to a vascular structure. In various embodiments, the straight-centerline stent 600 and / or the helical-centerline stent 610 can have an overall length between about 60 mm and about 100 mm, or of about 80 mm, allowing the electrode stent to provide a sufficient number of electrodes to effectively deliver stimulation while balancing power requirements for the electrodes.

[0068] Fig. 7 is a partially schematic diagram of an electrode stent 700 positioned within a patient's vein 701 in accordance with further embodiments of the present technology. In the embodiments illustrated in Fig. 7, the electrode stent 700 is generally similar to the electrode stent 500 discussed above with reference to Figs. 5 A-5C. For example, as illustrated in Fig. 7, the electrode stent 700 can include a main body 710 that includes a plurality of rings 712 coupled to a central connector 714. The electrode stent 700 also includes a plurality of electrodes 720 that are each carried by a corresponding one of the rings 712 and communi cably coupled to the central connector 714. When the electrode stent 700 is deployed in the patient’s vein 701 (e.g., the superior ophthalmic vein), the electrodes 720 can contact interior walls of the patient’s vein 701 to deliver stimulation thereto.

[0069] In the illustrated embodiments, the electrodes 720 are positioned on alternating sides of the main body 710. The alternating positioning can help ensure that a subset of the electrodes 720 is directed toward the optic nerve once the electrode stent 700 is deployed (e.g., within the superior ophthalmic vein), without requiring the delivery process to rotate the electrode stent 700 and / or otherwise carefully align the electrode stent 700. In various other embodiments, the electrodes 720 can be rotated other amounts (e.g., about 30 degrees (°), about 45°, about 70°, about 90°, about 120°, about 150°, and / or any other suitable amount) between adjacent rings to provide additional (or alternative) levels of coverage. In some embodiments, each of the rings 712 can carry multiple electrodes (e.g., two, three, four, and / or any other suitable numbers) to further increase the coverage from the electrode stent 700 irrespective of deployed orientation.

[0070] As further illustrated in Fig. 7, the electrode stent 700 can also include one or more anchors 716 (two illustrated in Fig. 7) coupled to (or integrally formed with) the main body 710. The anchors 716 can help attach the electrode stent 700 to the walls of the patient’s vein 701 at a target site during (and after) deployment. In the illustrated embodiment, the anchors 716 are positioned at a distal end of the main body 710. The distal positioning can, for example, allow the anchors 716 to attach to the walls of the patient’s vein 701 at the start of deployment and pull the-20- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) electrode stent 700 out of a retracting delivery' catheter. Additional details on various embodiments of the delivery process are discussed in more detail below.

[0071] Fig. 8 is a partially schematic diagram of an electrode stent 800 implanted in a patient’s vein 802 in accordance with embodiments of the present technology. Similar to the electrode stents discussed above, the electrode stent 800 illustrated in Fig. 8 includes a main body 810 and a plurality' of electrodes 820 carried by the main body 810. As further illustrated in Fig.8, the main body 810 can be flexible, allowing the electrode stent to contort to a tortuous anatomy of the patient's vein 802 (e.g., the superior ophthalmic vein). Further, once deployed, a subset of the electrodes 820 can be oriented towards the optic nerve (and / or another target in the patient’s brain). In such embodiments, the electrode stent 800 can deliver stimulation only through the subset of the electrodes 820 to deliver stimulation to the optic nerve without delivering stimulation to other, non-targeted regions of the patient's brain.

[0072] Figs. 9A-9D are partially schematic diagrams illustrating a process for endovascular implantation of an electrode stent 900 in accordance with embodiments of the present technology. In the illustrated embodiments, the electrode stent includes an expandable coil-shaped body composed of a biocompatible metal material, such as nitinol (NiTi), which provides superelasticity and shape memory to conform to vessel anatomy. The stent transitions from a collapsed configuration to an expanded configuration during deployment via a stent delivery system. The stent delivery’ system includes a dual-lumen catheter system with an outer cannula (e.g., stainless steel) and an inner cannula positioned coaxially within it. In some embodiments, the inner cannula includes an expandable component — such as an inflatable balloon — positioned at its distal tip. The electrode stent is mounted over this expandable component in a crimped or compressed state. During delivery, the outer cannula is advanced to a target site adjacent to the optic nerve via the vascular system (e.g., the superior ophthalmic vein). The inner cannula is then advanced beyond the outer cannula, positioning the balloon and stent at the target location. The balloon is inflated to expand the electrode stent into contact with the vessel wall, helping to conform the stent to the local vessel curvature and fix it in place. Once the stent is deployed and expanded, the balloon is deflated, and the catheter system is withdrawn. In its expanded configuration, the electrode stent may include a spiral interior that promotes swirling blood flow' to help reduce turbulence and restenosis. This configuration, along with the flexible metal construction, allows the stent to adapt to vessel curvature both during deployment and over time as the body changes. While not illustrated in Figs. 9A-9D, the electrode stent may carry electrodes and leads, as discussed elsewhere herein.-21- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33)

[0073] For the sake of clarity, several components of the electrode stent 900 (e.g., a lead coupled to the electrode stent, electrodes carried by the body, etc.) are not illustrated in Figs. 9A-9D. However, one of skill in the art will understand that the electrode stent 900 can include various other components discussed herein.

[0074] Fig. 10 is a flow diagram of a process 1000 for implanting an electrode stent in accordance with embodiments of the present technology. The process 1000 can be implemented using minimally invasive, endovascular catheter systems to deliver the electrode stent to a vascular structure (e.g., an ophthalmic vein) adjacent to the optic nerve.

[0075] The process 1000 begins at block 1002 by positioning a catheter device within a target vascular structure, such as an ophthalmic vein (e.g., the superior ophthalmic vein). The process 1000 at block 1002 can include accessing the patient’s veins through the jugular vein (or another suitable access point), and then advancing the catheter device through the venous system to the target vascular structure. For example, Figs. 11 A and 1 IB are partially schematic diagrams illustrating additional details on an endovascular procedure in accordance with embodiments of the present technology. As illustrated in Figs. 11A and 1 IB, the access at block 1002 of Fig. 10 can include forming an opening with an endovascular surgical device and advancing a catheter into the target vascular structure. Returning to the description of Fig. 10, the process 1000 at block 1002, in some embodiments, includes identifying the target vascular structure (e.g., via imaging of the patient’s nervous system to identify a location closest to the optic nerve). In some embodiments, the positioning at block 1002 includes obtaining one or more images (e.g., fluoroscopy, optical coherence tomography, ultrasound images, and / or the like) to help ensure that the catheter device is adjacent to a target location within the target vascular structure.

[0076] At block 1004, the process 1000 includes delivering an electrode stent to a target site within the target vascular structure via the catheter device. For example, the electrode stent can be delivered to the target site via a lumen in the catheter device. Similar to the discussion above, once the catheter device is positioned adjacent to the target site, the electrode stent can be advanced out of the lumen. In some embodiments, the delivery is accomplished by pushing the electrode stent out of the lumen. In some embodiments, the delivery is accomplished by pushing another tool (e.g., a sub-catheter, an inner cannula, and / or the like) carrying the electrode stent out of the lumen. In certain embodiments, the inner cannula includes an expandable component (e.g., a balloon) at its distal end, with the electrode stent positioned around the balloon in a collapsed configuration. In such embodiments, the balloon can be expanded (e.g., inflated with a fluid or-22- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) gas) at the target site to expand the electrode stent into position. In some embodiments, the delivery is accomplished by partially retracting the catheter device while maintaining a position of the electrode stent. In some embodiments, the delivery at block 1004 includes obtaining one or more images (e.g., fluoroscopy, optical coherence tomography, ultrasound images) to help ensure that the electrode stent is delivered to the correct location.

[0077] Once delivered, at block 1006, the process 1000 includes expanding the electrode stent at the target site and anchoring the electrode stent to walls of the vascular structure. In various embodiments, the electrode stent can include a self-expanding body and / or a shape-memoiy material (e.g., nitinol) configured to retain an expanded configuration. As the electrode stent expands, the electrode stent can contact the walls of the vascular structure. Purely by way of example, similar to the discussion above, an expandable device (e.g., a balloon integrated into the inner cannula) can expand the electrode stent at the target location. The electrode stent can then remain in the expanded configuration after balloon deflation and withdrawal. In other embodiments, the electrode stent may self-expand upon release from the catheter lumen. In some embodiments, the contact applies anchors of the electrode stent to the walls to hold the electrode stent in place. In some embodiments, pressure between the expanding body of the electrode stent and the walls of the vascular structure holds the electrode stent in place.

[0078] At block 1008, the process 1000 includes retracting the catheter device back through the patient’s vascular system. As the catheter device is retracted, the catheter device can eject a connector (e g., one or more conductive wires) and / or fix the connector to relevant vascular structures (e.g., walls of the vascular system), thereby providing an electrical connection to the electrode stent. Then, at block 1010, the process 1000 includes coupling the electrode stent to a stimulation device (e.g.. an IPG and / or other suitable stimulation device). The process 1000 at block 1010 can include a surgical process to place the stimulation device in a suitable location (e.g., on the anterior chest wall) and a tunneling process to couple the stimulation device to the connector within the vascular system. Alternatively, the process 1000 at block 1010 can include tunneling to a location at or near the patient's ear (e.g., a periauricular area) to couple an externally accessible stimulation device to the connector.

[0079] At block 1012. after the surgical processes are complete, the process 1000 includes delivering bipolar stimulation to the patient’s optic nerve via the electrode stent. For example, once the stimulation device is coupled to the electrode stent, the stimulation device can provide input signals (e.g., a drive current) to electrodes on the electrode stent, thereby delivering-23- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) stimulation to the target site that propagates to the optic nerve. Additional details on various examples of processes for dynamically delivering stimulation are discussed below.Examples of Suitable Methods for Operating Electrode Stents and Related Systems and Methods in Accordance with Embodiments of the Present Technology

[0080] Fig. 12 is a flow diagram of a process 1200 for evolving stimulation parameters for an electrode stent in accordance with embodiments of the present technology. In various embodiments, the process 1200 can be implemented by one or more computing devices. For example, the process 1200 of Fig. 12 can be implemented entirely by a stimulation generator (e.g., the stimulation generation component 114 of Fig. 1). Alternatively, the process 1200 of Fig. 12 can be split between the stimulation generator and one or more peripheral devices (e.g., the patient user device 120 of Fig. 1, the medical user device 130, and / or any other suitable computing device).

[0081] The process 1200 can begin at block 1202 by delivering stimulation to a patient’s optic nerve via one or more stimulating electrodes in an electrode stent (e.g., the stent stimulation component 112 of Fig. 1) based on a current stimulation protocol. For example, the stimulation device (e.g., an IPG, a stimulation device in the periauricular area, and / or the like) can provide a drive current to one or more electrodes in the electrode stent. The stimulation protocol can define a variety of operating parameters at block 1202. For example, the stimulation protocol can define various parameters of the drive current (e.g., magnitude, frequency, pulse width, pulse frequency, and / or the like), which electrodes are stimulating electrodes (e.g., identifying a subset of electrodes on the electrode stent), and / or a duration of the stimulation.

[0082] At block 1204. the process 1200 includes recording neural activity in the patient's optic nerve via one or more recording electrodes on the electrode stent. That is, the process 1200 includes recording neural activity in the optic nen e in response to the stimulation that is delivered at block 1202. In some embodiments, the recording at block 1204 includes recording electrically evoked potentials from the optic nene and / or from a visual cortex of the patient. The visual cortex measurements can be obtained via additional recording electrodes positioned in or near the visual cortex, and / or via external electroencephalography (EEG) measurements. The visual cortex measurements can provide additional data on the efficacy of the stimulation in activating visual pathways. In some embodiments, the electrode stent includes one or more dedicated recording electrodes. In some embodiments, the recording electrodes are a subset of the electrodes designated by the cunent stimulation protocol (and, in various other protocols, can be used to-24- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) deliver stimulation). In some embodiments, the recording is then communicated from the stimulation generator to a peripheral device (e.g., a patient user device, a medical user device, a cloud system, and / or the like).

[0083] At block 1206, the process 1200 includes identifying one or more regions of the optic nerve that exhibit reduced (or abnormal) and / or increased firing patterns. For example, the process 1200 can include comparing the recorded activity to a baseline specific to the patient before delivering stimulation, a baseline specific to the patient during previous stimulations, and / or a general population baseline. Identifying the reduced and / or increased firing patterns can help identify trends in the patient’s optic nerve related to an optic neuropathy, trends related to responses to various stimulation patterns and / or parameters, and / or the like.

[0084] Then, at block 1208, the process 1200 includes adapting the stimulation protocol based on the identified regions of reduced and / or increased firing patterns. The adaptation can seek to maximize activity in the optic nerve, match activity in the optic nerve to a baseline (e.g., the patient-specific baseline and / or the general population baseline), vary optic nerve activity to maintain neural connections, and / or the like. In some embodiments, the adaptation is based on a predetermined model to vary the stimulation protocol based on the measured activity. In some embodiments, the adaptation is based on an evolving stimulation model to search for operating parameters that maximize and / or optimize firing patterns.

[0085] For example, the process 1200 can employ an adaptive stimulation model to help drive stimulation of the optic nerve. The adaptive stimulation model can incorporate simulations based on Hodgkin-Huxley equations for nerve fiber bundle stimulation, including sodium (gNa+), potassium (gK+), and leak (gLeak) conductance to accurately simulate the behavior of optic nerve axons. The adaptive stimulation capabilities of the electrode stent system, enabled by the machine learning algorithm and closed-loop control, can provide a variety of benefits over a fixed-parameter stimulation approach. For example, by continuously optimizing the stimulation based on the individual patient's neural activity and response, the process 1200 (and the electrode stent system) can achieve better outcomes and / or help reduce (or minimize) side effects associated with the stimulation. In one example of the adaptive model, the process 1200 can compare the recorded activity patterns with a set of target patterns associated with healthy optic nen e function. The process 1200 can then employ convolutional neural networks (CNNs) and / or genetic algorithms to evolve the operating parameters in the stimulation over multiple iterations to optimize therapy based on each patient’s specific optic neuropathy, anatomical responses, and / or the like.-25- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33)

[0086] By placing a multi-contact stimulation electrode near the optic nerve (e.g., via the ophthalmic artery) and providing closed-loop electrical stimulation, the systems and methods disclosed herein can selectively stimulate specific nerve fiber bundles and tailor the stimulation parameters to individual patient responses using machine learning algorithms. For example, the Hodgkin-Huxley model is adapted to simulate the behavior of optic nerve axons, allowing for precise control of the stimulation parameters. In a specific, non-limiting example, the electrode stimulation system can target bipolar cells (BCs) to help treat retinal degeneration during an early phase of the degeneration. In this example, the adaptive stimulation model can be focused on varying pulses with long pulse durations to help decrease an activation threshold of the BCs and / or a differential stimulus threshold between retinal ganglion cells (RGCs) and the BCs.

[0087] As discussed above, the endovascular approach to optic nerve stimulation is expected to be able to target a wider range of optic neuropathies (e.g., retinitis pigmentosa, glaucoma, ischemic optic neuropathy, and traumatic optic neuropathy, and / or the like). Further, the personalized, adaptive stimulation models disclosed herein can help optimize therapeutic outcomes and / or reduce (or minimize) side effects associated with these conditions. For example, the use of the Hodgkin-Huxley model can allow for more accurate predictions of the neural response to stimulation across different pathological conditions.

[0088] In various embodiments, the process 1200 at block 1208 can employ various suitable machine learning algorithms, such as reinforcement learning (RL) and / or Bayesian optimization models. RL algorithms aim to learn optimal control policies through interaction with an environment, balancing exploration and exploitation to maximize a cumulative reward signal. In the context of optic nerve stimulation, the RL algorithm could learn to adjust stimulation parameters (e.g., pulse amplitude, duration, and frequency) based on the patient's neural response, to try to optimize therapeutic outcomes while minimizing side effects.

[0089] In a specific, non-limiting example, the RL algorithm can include deep Q-leaming, which combines Q-leaming with deep neural networks to handle high-dimensional state and action spaces. The deep Q-network (DQN) can take recorded neural activity data (e.g., electrophysiological recordings, optical coherence tomography, and / or the like) as an input and then output operating parameters for the stimulation system. A reward signal for the Q-leaming, in this example, can be based on a variety of factors, such as improvements in visual function, reduction (or reversal) in disease progression, and / or a reduction (or minimization) of adverse effects.-26- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33)

[0090] Bayesian optimization models are well-suited for optimizing complex, expensive-to-evaluate functions. In the case of optic nene stimulation, the objective function for the Bayesian optimization can be a measure of therapeutic efficacy. In this example, it can be costly and time-consuming to assess therapeutic efficacy for each set of possible operating parameters for the stimulation system. Instead, Bayesian optimization can construct a probabilistic model of the objective function (e.g., using Gaussian processes), then use the probabilistic model to guide a search for optimal stimulation settings. In this example, the Bayesian optimization can balance exploration and exploitation based on the model’s uncertainty.

[0091] In addition to, or as an alternative to, the optimization-focused algorithms discussed above, the process 1200 can employ various unsupervised learning techniques (e.g., clustering and / or anomaly detection) to help identity' patterns in patient responses and / or detect unusual or adverse reactions to stimulation. For example, the process 1200 can employ a k-means clustering analysis to group patients based on their neural response profiles, thereby enabling the development of cluster-specific stimulation protocols. In another example, the process 1200 can employ anomaly detection algorithms (e.g., isolation forests and / or autoencoders) to help monitor patient responses in real time and alert clinicians to potential safety concerns.

[0092] In some embodiments, the adaptive, closed-loop stimulation of the optic nerve depends on real-time measurements of the electrical activity of the nerve to increase an accuracy of the evolution. As discussed above, the real-time measurements can be made by incorporating recording electrodes (or designating electrodes for recording) alongside the stimulation electrodes on the electrode stent device. The recording electrodes can be designed to detect extracellular potentials generated by the optic nerve fibers in response to both natural visual stimuli and artificial electrical stimulation. In some embodiments, the recording electrodes are fabricated from biocompatible, conductive materials, such as platinum-iridium alloys, PEDOT:PSS, gold, or conductive polymers. These materials exhibit excellent electrical properties, low impedance, and high signal-to-noise ratios, which can be important for neural-recording applications. In some embodiments, the recording electrodes are arranged in a multi-contact array, with each contact targeting a specific region of the optic nerve to help the electrode stent provide spatially -resolved monitoring of neural activity'.

[0093] The ability to record optic nerve activity’ directly from the endovascular stent is expected to provide direct insights into real-time dynamics of visual processing and disease progression within the patient’s optic ner e. As a result, the recordings can allow the process 1200-27- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) to continuously adjust the stimulation protocol based on the individual patient's neural response. Furthermore, the longitudinal monitoring of optic nerve activity can help track the efficacy of the neuromodulation therapy over time to help inform personalized treatment strategies and / or better understand neural pathologies at a broader level.

[0094] In some embodiments, the electrode stent and / or the stimulation generator can include features to help increase the accuracy of the recorded neural signals. For example, the recorded neural signals can be amplified, filtered, and / or digitized using low-noise, high-bandwidth electronics embedded within the electrode stent and / or the stimulation generator. The filtering electronics can be configured to handle the specific characteristics of optic nerve activity, such as the frequency range and amplitude of the extracellular potentials. Additionally, or alternatively, digitized signals can be further processed within the stimulation generator before analysis by the machine learning (or other) algorithms.

[0095] In some embodiments, the electrode array is designed using computational modeling techniques (e.g., finite element analysis (FEA)) to help optimize the recording capability of the electrode stent. For example, FEA simulations can help determine an optimal size, spacing, and / or configuration of the recording electrodes to increase (or maximize) signal quality and / or reduce (or minimize) crosstalk between channels. Additionally, or alternatively, the simulations can help guide the placement (e.g., help identify a target location) of the electrode stent within a vascular structure (e.g., the ophthalmic artery) to ensure close proximity to the optic nerve and optimal recording sensitivity.

[0096] To help ensure a long-term stability and / or reliability7of the neural recordings, the electrode stent can incorporate various encapsulation and / or insulation materials to protect the electrodes (and other electronics) from the physiological environment. For example, the electrode stent can include various biocompatible coatings (e.g., parylene and / or polyimide), to prevent biofouling while maintaining the integrity of the electrode-tissue interface over extended periods.Further Examples of Systems Associated with Electrode Stents for Stimulating Optic Ner es in Accordance with Further Embodiments of the Present Technology

[0097] Fig. 13 is a partially schematic diagram of a system 1300 for treating vision disorders configured in accordance with further embodiments of the present technology. In the illustrated embodiment, the system 1300 includes components that are generally similar to components of the system 100 discussed above with reference to Fig. 1. For example, the system 1300 includes a stent stimulation component positioned within a vascular structure adjacent to the optic nerve-28- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) (e.g., within the patient’s superior ophthalmic vein) and a stimulation generation device positioned within the patient’s chest and operably coupled to the stent stimulation component. In some embodiments, the stimulation generation device and the stent stimulation component operate as a standalone system. In some embodiments, the stimulation generation device and / or the stent stimulation component are coupled to various peripheral components. For example, the stimulation generation device can be communi cably coupled to a patient user device (e.g., alaptop or desktop computer), a medical user device, and / or the like. During an example of operation of the system 1300, the stimulation generation device can control the characteristics and / or operating parameters of the stent stimulation component, thereby controlling various characteristics and / or parameters of stimulation that are delivered to the patient. In some embodiments, the control implemented by the stimulation generation device is based at least partially on control implemented by the patient user device (e.g., defining a stimulation protocol, tweaking goals for the characteristics and / or parameters of stimulation that are delivered to the patient, defining the operating parameters, and / or the like) and / or a medical user device. In various embodiments, the communicative coupling between the stimulation generation device and the patient user device (and / or any other suitable user device, such as the user device of a medical professional) can be wired or wireless. For example, the subcutaneous device in the patient’s chest can have one or more connections accessible on the user’s skin for communication and / or one or more communication components (e.g., Wi-Fi components, short range wireless components (e.g., Bluetooth®), and / or the like) to enable wireless communication.

[0098] Further, in various embodiments, the system 1300 can include various peripheral sensors and / or components, such as an eye-tracking device that can track the patient’s eyes on a screen of the patent user device. In such embodiments, the system 1300 can then use information related to where the patient’s eyes are directed to further review recordings of the neural activity to better understand the patient's condition, how stimulation is affecting the optic nerve, and / or how to evolve operating parameters of the system 1300.

[0099] Fig. 13 also schematically illustrates various details related to routes available for implanting the stent stimulation component. For example, as illustrated in Fig. 13, the stent stimulation component can be implanted through cannulation of the superior ophthalmic vein, endovascular path via the internal jugular vein toward the inferior petrosal sinus / cavemous sinus region, and / or the like. As further illustrated in Fig. 13, the superior ophthalmic vein provides a combination of vascular access and close proximity to the optic nerve.-29- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) Examples

[0100] The present technology is illustrated, for example, according to various aspects described below. Various examples of aspects of the present technology are described as numbered examples (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the present technology. It is noted that any of the dependent examples can be combined in any suitable manner, and placed into a respective independent example. The other examples can be presented in a similar manner.1. An implantable stimulation system for providing stimulation to an optic nerve of a patient, the implantable stimulation system comprising:a stimulation generator;an electrode stent positionable at a target site within an ophthalmic vein of the patient adjacent to the optic nerve, the electrode stent comprising:a main stent body extending from a proximal end region to a distal end region, the main stent body actionable between a collapsed configuration and an expanded configuration;a plurality of electrodes carried by the main stent body and distributed between the proximal end region and the distal end region; and a connector electrically coupled to each of the plurality of electrodes, wherein the connector comprises an individual connection lead for each electrode in the plurality of electrodes and terminal contacts at the proximal end region of the mam stent body; anda lead component electrically coupled between the terminal contacts of the connector in the electrode stent and the stimulation generator.2. The implantable stimulation system of example 1 wherein the stimulation generator comprises a microprocessor configured to implement an adaptive stimulation algorithm.3. The implantable stimulation system of example 2 wherein the stimulation generator is configured to identify injured or degenerating segments of the optic nerve based on abnormal neural activity patterns detected by a subset of the plurality of electrodes.-30- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) 4. The implantable stimulation system of examples wherein the stimulation generator is configured to deliver targeted stimulation to the identified injured or degenerating segments via another subset of the plurality of electrodes.5. The implantable stimulation system of any of examples 2-4 wherein the adaptive stimulation algorithm incorporates simulations based on Hodgkin-Huxley equations for nerve fiber bundle stimulation, including sodium, potassium, and leak conductances.6. The implantable stimulation system of any of examples 2-5 wherein the adaptive stimulation algorithm comprises a machine learning algorithm responsive to measurements of the optic nerve received from a subset of the plurality of electrodes.7. The implantable stimulation system of example 6 wherein the machine learning algorithm comprises a convolutional neural network trained to predict optimal stimulation paterns based on recorded neural activity.8. The implantable stimulation system of any of examples 2-7 wherein the adaptive stimulation algorithm modifies one or more operating parameters for the electrode stent, wherein the one or more operating parameters include:an indication of a first subset of the plurality electrodes delivering stimulation during operation;an indication of a second subset of the plurality electrodes recording data from the optic nerve during operation;a magnitude of the stimulation delivered during operation; and / ora frequency of the stimulation delivered during operation.9. The implantable stimulation system of any of examples 2-8 wherein the adaptive stimulation algorithm is configured to generate biphasic stimulus pulses with pulse durations configured to decrease activation thresholds of bipolar cells.10. The implantable stimulation system of any of examples 1-9 wherein the main stent body has a primary longitudinal axis, and wherein the plurality of electrodes are radially distributed about the primary' longitudinal axis.-31- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) 11. The implantable stimulation system of example 10 wherein, when the electrode stent is positioned at the target site within the ophthalmic vein, a subset of the plurality of electrodes are directed toward the optic nerve.12. The implantable stimulation system of any of examples 1-11 wherein the main stent body comprises a spiral wire extending from the proximal end region to the distal end region13. The implantable stimulation system of example 12 wherein the plurality of electrodes comprise a first subset of electrodes positioned along helix portions of the spiral wire and a second subset of electrodes posited between the helix portions.14. The implantable stimulation system of any of examples 1-13 wherein the main stent body comprises a helical stent, and wherein each of the plurality of electrodes is carried by a corresponding helix in the helical stent.15. The implantable stimulation system of any of examples 1-14 wherein the main stent body comprises:an outer layer having a first braided structure;an inner layer having a second braided structure; anda secondary layer between the outer layer and the inner layer, wherein each of the plurality of electrodes is carried by the secondary7layer.16. The implantable stimulation system of any of examples 1-15 wherein a distal end region of the electrode stent includes a pre-shaped curve configured to direct the plurality of electrodes toward the optic nerve when the electrode stent is positioned in the ophthalmic vein.17. The implantable stimulation system of example 16 wherein the pre-shaped curve is formed from a shape-memory material.18. The implantable stimulation system of any of examples 1-17 wherein the main stent body is detachable from the lead component.-32- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) 19. The implantable stimulation system of any of examples 1-18 wherein the target site is within an anterior portion of a cavernous sinus of the patient.20. The implantable stimulation system of any of examples 1-19 further comprising a steering mechanism configured to facilitate navigation of the electrode stent through venous vasculature to the target site.21. The implantable stimulation system of any of examples 1-20 wherein the electrode stent is selected from a plurality of available configurations based on patient-specific venous anatomy.22. A method for implanting an electrode stent, the method comprising: endovascularly positioning a catheter device adjacent to a target location within a vascular structure, wherein the target location is adjacent to an optic nerve of a patient; delivering the electrode stent, in a collapsed configuration, to the target location via a lumen of the catheter device;expanding the electrode stent at the target location;retracting the catheter device.23. The method of example 22 further comprising:recording neural activity from the optic nen e via a subset of electrodes on the electrode stent;identifying injured or degenerating segments of the optic nerve based on abnormal neural activity patterns in the recorded neural activity; anddelivering targeted stimulation to the identified injured or degenerating segments via another subset of electrodes on the electrode stent.24. The method of example 23 wherein recording neural activity comprises recording electrically evoked potentials from the optic nerve or a visual cortex of the patient.25. The method of any of examples 22-24 further comprising:coupling the electrode stent to a stimulation generator;-33- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) delivering stimulation to the optic nerve via a first subset of electrodes on the electrode stent;recording neural activity from the optic nerve via a second subset of electrodes on the electrode stent; andadapting one or more stimulation parameters based on the recorded neural activity using an adaptive stimulation algorithm implemented by the stimulation generator.26. An implantable stimulation system for providing stimulation to an optic nerve of a patient, the implantable stimulation system comprising:a stimulation generator comprising a microprocessor; andan electrode stent positionable at a target site within a vascular structure of the patient adjacent to the optic nerve and operably coupled to the stimulation generator, the electrode stent comprising:a self-expanding main stent body extending from a proximal end region to a distal end region, the main stent body configured to transition between a collapsed configuration for endovascular delivery and an expanded configuration for contact with a wall of the vascular structure;a plurality of stimulating electrodes carried by the main stent body and configured to deliver electrical stimulation to the optic nerve;a plurality of recording electrodes earned by the mam stent body and configured to detect neural activity from the optic nerve; anda connector electrically coupled to each of the plurality of stimulating electrodes and each of the plurality of recording electrodes,27. The implantable stimulation system of example 26 wherein the microprocessor is configured to implement an adaptive stimulation algorithm that modifies stimulation parameters based on the neural activity detected by the plurality of recording electrodes28. The implantable stimulation system of example 27 wherein the adaptive stimulation algorithm comprises a machine learning algorithm configured to adjust the stimulation parameters in real time using a closed-loop control system responsive to the neural activity detected by the plurality of recording electrodes.-34- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) 29. The implantable stimulation system of any of examples 26-28 wherein the vascular structure comprises a superior ophthalmic vein or an anterior portion of a cavernous sinus.30. The implantable stimulation system of any of examples 26-29 wherein the main stent body comprises a biocompatible, superelastic material wound in a spiral configuration defining an open-cell structure.31. The implantable stimulation system of any of examples 26-30 wherein the main stent body comprises:an outer layer having a first braided structure;an inner layer having a second braided structure that is more densely braided than the first braided structure; anda secondary7layer positioned between the outer layer and the inner layer, wherein the plurality of stimulating electrodes and the plurality of recording electrodes are carried by the secondary layer.32. The implantable stimulation system of any of examples 26-31 wherein the plurality of stimulating electrodes and the plurality7of recording electrodes are radially distributed about a longitudinal axis of the main stent body such that, when the electrode stent is positioned at the target site, a subset of the plurality of stimulating electrodes is directed toward the optic nerve regardless of a rotational orientation of the electrode stent yvithin the vascular structure.33. The implantable stimulation system of any of examples 26-32 wherein the main stent body is coated with a biocompatible polymer encapsulating the main stent body and at least a portion of the plurality of stimulating electrodes and the plurality of recording electrodes. Conclusion

[0101] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. To the extent any material incorporated herein by reference conflicts with the present disclosure, the present disclosure controls. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.-35- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Furthermore, as used herein, the phrase “and / or” as in “A and / or B” refers to A alone, B alone, and both A and B. Additionally, the terms “comprising,” “including,” “having,” and “with” are used throughout to mean including at least the recited feature(s) such that any greater number of the same features and / or additional types of other features are not precluded. Further, the terms “generally, “approximately,” and “about” are used herein to mean within at least within 10% of a given value or limit. Purely by way of example, an approximate ratio means within 10% of the given ratio.

[0102] Several implementations of the disclosed technology7are described above in reference to the figures. The computing devices on which the described technology may be implemented can include one or more central processing units, memory7, input devices (e.g., keyboard and pointing devices), output devices (e.g., display devices), storage devices (e.g., disk drives), and network devices (e.g., network interfaces). The memory7and storage devices are computer-readable storage media that can store instructions that implement at least portions of the described technology. In addition, the data structures and message structures can be stored or transmitted via a data transmission medium, such as a signal on a communications link. Various communications links can be used, such as the Internet, a local area network, a wide area network, or a point-to-point dial-up connection. Thus, computer-readable media can comprise computer-readable storage media (e.g.. “non-transitory” media) and computer-readable transmission media.

[0103] From the foregoing, it will also be appreciated that various modifications may be made without deviating from the disclosure or the technology. For example, one of ordinary skill in the art will understand that various components of the technology can be further divided into subcomponents, or that various components and functions of the technology may be combined and integrated. In addition, certain aspects of the technology described in the context of particular embodiments may also be combined or eliminated in other embodiments.

[0104] Furthermore, although advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.-36- 526600'00016\4925-4039-4402\1

Claims

P333363.WO.01 (AE8O33)CLAIMSWe claim:

1. An implantable stimulation system for providing stimulation to an optic nerve of a patient, the implantable stimulation system comprising:a stimulation generator;an electrode stent positionable at a target site within an ophthalmic vein of the patient adjacent to the optic nerve, the electrode stent comprising:a main stent body extending from a proximal end region to a distal end region, the main stent body actionable between a collapsed configuration and an expanded configuration;a plurality of electrodes carried by the main stent body and distributed between the proximal end region and the distal end region; and a connector electrically coupled to each of the plurality of electrodes, wherein the connector comprises an individual connection lead for each electrode in the plurality of electrodes and terminal contacts at the proximal end region of the main stent body; anda lead component electrically coupled between the terminal contacts of the connector in the electrode stent and the stimulation generator.

2. The implantable stimulation system of claim 1 wherein the stimulation generator comprises a microprocessor configured to implement an adaptive stimulation algorithm.

3. The implantable stimulation system of claim 2 wherein the stimulation generator is configured to:identity’ injured or degenerating segments of the optic nerve based on abnormal neural activity’ patterns detected by a first subset of the plurality of electrodes; and deliver targeted stimulation to the identified injured or degenerating segments via a second subset of the plurality of electrodes.-37- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) 4. The implantable stimulation system of claim 2 wherein the adaptive stimulation algorithm incorporates simulations based on Hodgkin-Huxley equations for nerve fiber bundle stimulation, including sodium, potassium, and leak conductances.

5. The implantable stimulation system of claim 2 wherein the adaptive stimulation algorithm comprises a machine learning algorithm responsive to measurements of the optic nerve received from a subset of the plurality of electrodes.

6. The implantable stimulation system of claim 2 wherein the adaptive stimulation algorithm modifies one or more operating parameters for the electrode stent, wherein the one or more operating parameters include:an indication of a first subset of the plurality electrodes delivering stimulation during operation;an indication of a second subset of the plurality electrodes recording data from the optic nerve during operation;a magnitude of the stimulation delivered during operation; and / ora frequency of the stimulation delivered during operation.

7. The implantable stimulation system of claim 2 wherein the adaptive stimulation algorithm is configured to generate biphasic stimulus pulses with pulse durations configured to decrease activation thresholds of bipolar cells.

8. The implantable stimulation system of claim 1 wherein the main stent body has a primary longitudinal axis, and wherein the plurality of electrodes are radially distributed about the primary longitudinal axis.

9. The implantable stimulation system of claim 8 wherein, when the electrode stent is positioned at the target site within the ophthalmic vein, a subset of the plurality of electrodes are directed toward the optic nerve.

10. The implantable stimulation system of claim 1 wherein the main stent body comprises a spiral wire extending from the proximal end region to the distal end region.-38- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) 11. The implantable stimulation system of claim 10 wherein the plurality of electrodes comprise a first subset of electrodes positioned along helix portions of the spiral wire and a second subset of electrodes posited between the helix portions.

12. The implantable stimulation system of claim 1 wherein the main stent body comprises a helical stent, and wherein each of the plurality of electrodes is carried by a corresponding helix in the helical stent.

13. The implantable stimulation system of claim 1 wherein the main stent body comprises:an outer layer having a first braided structure;an inner layer having a second braided structure; anda secondary’ layer between the outer layer and the inner layer, wherein each of the plurality of electrodes is carried by the secondary layer.

14. The implantable stimulation system of claim 1 wherein a distal end region of the electrode stent includes a pre-shaped curve configured to direct the plurality of electrodes toward the optic nerve when the electrode stent is positioned in the ophthalmic vein.

15. A method for implanting an electrode stent, the method comprising: endovascularly positioning a catheter device adjacent to a target location within a vascular structure, wherein the target location is adjacent to an optic nerve of a patient; delivering the electrode stent, in a collapsed configuration, to the target location via a lumen of the catheter device;expanding the electrode stent at the target location; andretracting the catheter device.

16. The method of claim 15 further comprising:recording neural activity from the optic nerve via a subset of electrodes on the electrode stent;identifying injured or degenerating segments of the optic nerve based on abnormal neural activity patterns in the recorded neural activity; and-39- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) delivering targeted stimulation to the identified injured or degenerating segments via another subset of electrodes on the electrode stent.

17. The method of claim 16 wherein recording neural activity comprises recording electrically evoked potentials from the optic nerve or a visual cortex of the patient.

18. The method of claim 15 further comprising:coupling the electrode stent to a stimulation generator;delivering stimulation to the optic nerve via a first subset of electrodes on the electrode stent;recording neural activity from the optic nerve via a second subset of electrodes on the electrode stent; andadapting one or more stimulation parameters based on the recorded neural activity using an adaptive stimulation algorithm implemented by the stimulation generator.

19. An implantable stimulation system for providing stimulation to an optic nerve of a patient, the implantable stimulation system comprising:a stimulation generator comprising a microprocessor; andan electrode stent positionable at a target site within a vascular structure of the patient adjacent to the optic nerve and operably coupled to the stimulation generator, the electrode stent comprising:a self-expanding main stent body extending from a proximal end region to a distal end region, the main stent body configured to transition between a collapsed configuration for endovascular delivery and an expanded configuration for contact with a wall of the vascular structure;a plurality of stimulating electrodes carried by the main stent body and configured to deliver electrical stimulation to the optic nerve;a plurality of recording electrodes carried by the main stent body and configured to detect neural activity from the optic nerve; anda connector electrically coupled to each of the plurality of stimulating electrodes and each of the plurality of recording electrodes.-40- 526600'00016\4925-4039-4402\1P333363.WO.01 (AE8O33) 20. The implantable stimulation system of claim 19 wherein the microprocessor is configured to implement an adaptive stimulation algorithm that modifies stimulation parameters based on the neural activity detected by the plurality of recording electrodes.

21. The implantable stimulation system of claim 20 wherein the adaptive stimulation algorithm comprises a machine learning algorithm configured to adjust the stimulation parameters in real time using a closed-loop control system responsive to the neural activity detected by the plurality of recording electrodes.-41- 526600'00016\4925-4039-4402\1

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