WO2026033312A1

WO2026033312A1 - Electrode configurations and fixation for endovascular therapy system

Info

Publication number: WO2026033312A1
Application number: PCT/IB2025/057643
Authority: WO
Inventors: Varun Umesh KASHYAP; Kevin V. Nguyen; Ashok NAGESWARAN; Saeid BAHREMAND; Erik P. Fahimi; Robert L. Olson; Dale F. Seeley; Mark Philip Ashby; Alexander A. Khalessi
Original assignee: Covidien LP
Current assignee: Covidien LP
Priority date: 2024-08-05
Filing date: 2025-07-28
Publication date: 2026-02-12
Anticipated expiration: 2027-02-05

Abstract

An endovascular medical device system includes an elongated body, an expandable structure at a distal portion of the elongated body, and one or more electrodes. The expandable structure includes an expandable frame defining one or more apertures and each electrode is mechanically coupled to the expandable structure via a respective aperture of the one or more apertures. In some examples, each electrode defines a first maximum dimension in a first direction along a central longitudinal axis of the expandable structure and a second maximum dimension in a second direction transverse to the first direction, wherein the first maximum dimension is greater than the second maximum dimension. In some examples, when each electrode is mechanically coupled to the expandable structure, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

Description

Docket No. A0012241W001

ELECTRODE CONFIGURATIONS AND FIXATION FOR ENDOVASCULAR THERAPY SYSTEM

CROSS-RELATED APPLICATION

[0001] This Application claims priority from U.S. Provisional Patent Application 63/679,491, filed 5 August 2024, the entire content of which is incorporated herein by reference.

TECHNICAL BACKGROUND

[0002] This disclosure relates to electrical stimulation therapy.

BACKGROUND

[0003] Medical devices, such as electrical stimulation devices, may be used in different therapeutic applications, such as vagus nerve stimulation (VNS) and/or deep brain stimulation (DBS). A medical device may be used to deliver therapy to a patient to treat a variety of symptoms or patient conditions. In some therapy systems, an external or an implantable electrical stimulator delivers electrical stimulation therapy to a target tissue site within a patient with the aid of one or more electrodes and/or senses one or more patient parameters with the aid of the one or more electrodes.

SUMMARY

[0004] This disclosure describes example endovascular medical devices and systems configured to endovascularly deliver electrical stimulation therapy to a patient (e.g., to one or more nerves or brain targets) and/or sense one or more patient parameters (e.g., nerve signals, brain signals, and/or other physiological parameters), and related methods. In particular, this disclosure describes configurations for structures of medical devices and systems that facilitate delivery of electrical stimulation therapy and/or sensing patient parameters from an endovascular location.

[0005] In the examples described herein, an endovascular therapy system includes one or more electrodes and/or other sensing elements that are carried by an expandable structure at a distal portion of an elongated body of an endovascular device (e.g., a medical lead). The expandable structure (e.g., which can include a frame that includes a plurality of connected struts, such as a stent or stent-like structure or another expandable Docket No. A0012241W001 frame-like structure) is configured to transform between a delivery (e.g., relatively low- profile or compressed, including radially compressed) configuration and a deployed (e.g., expanded, including radially expanded) configuration. One or more electrodes and/or sensing elements are mechanically coupled to, disposed on, or otherwise carried by the expandable structure. Each electrode and/or sensing element is electrically connected to a medical device via one or more conductor wires. The medical device is configured to deliver therapy (e.g., electrical stimulation therapy) and/or received sensed signals via the electrodes or sensing elements by way of the conductor wires. The conductor wires can extend from the medical device, along (e.g., within) the elongated body of the endovascular device, and distal of the elongated body to electrically connect to each electrode or sensing element. While this disclosure primarily discusses electrodes attached to an expandable structure, one or more other sensing elements can additionally or alternatively be attached to the expandable structures described herein.

[0006] In some examples, the expandable structure and at least a portion of the endovascular device (e.g., the medical lead) are configured be introduced into and advanced within a blood vessel of a patient, such as to position the electrodes and/or sensing elements proximate a target location (e.g., proximate a location with target anatomical structures such as nerves or brain tissue proximate the blood vessel). For example, in some examples, the expandable structure and at a least a portion of the endovascular device (e.g., the medical lead) are configured to be delivered to the target location with the aid of an introducer sheath, a delivery catheter, or the like. A delivery (e.g., relatively low-profile or compressed, including radially compressed) configuration of the expandable structure can enable the expandable structure and/or a portion of the endovascular device (e.g., the medical lead) to be positioned within the introducer sheath and/or delivery catheter (e.g., within a lumen defined by the introducer sheath and/or delivery catheter).

[0007] In some examples herein, portions of the expandable structure include structural features that facilitate mechanical coupling of one or more electrodes to the expandable structure. In some examples, the expandable structure defines one or more apertures configured to enable and/or facilitate mechanical coupling the electrodes to the expandable structure. For example, in some examples, each aperture is sized, shaped, and/or otherwise configured to receive one or more structures (e.g., an electrode fixation element and/or a crimp structure) configured to mechanically couple a respective electrode to the expandable structure. Thus, because electrodes can be fabricated Docket No. A0012241W001 separately from the expandable structure, properties of electrodes (e.g., size, shape, conductive surface area) can be selected and/or adjusted during fabrication, manufacturing, and/or assembly for a particular end use, and the electrode assemblies can subsequently be attached to the expandable structure via the electrode attachment elements.

[0008] In some examples, the structural features of the expandable structure that enable and/or facilitate mechanical coupling of the electrodes to the expandable structure are configured to orient the electrodes in a way such as to enable a relatively large size (e.g., a relatively large electrically conductive surface area) of each electrode while also limiting or preventing a possibility of physical interference between electrodes during transformation of the expandable structure between the delivery (e.g., radially compressed) configuration and the deployed (e.g., radially expanded) configuration. For example, in some examples, each electrode defines an oblong shape (e.g., having a first, longer dimension as measured in a first direction, which can be referred to as a major axis, and a second, shorter dimension as measured in a second direction, which can be referred to as a minor axis), and the longer dimension of the oblong shape extends along a longitudinal axis of the expandable structure when the oblong electrode is mechanically coupled to the expandable structure. In some examples, the structural features of the expandable structure that enable and/or facilitate mechanical coupling of the electrodes to the expandable structure are configured to orient each electrode such that the first, longer dimension of each oblong electrode is positioned in a first direction along a central longitudinal axis of the expandable structure and such that the second shorter dimension (e.g., that is less than the first dimension) of each oblong electrode is positioned transverse to the first direction. In some examples, the second direction is orthogonal to the first direction.

[0009] In some examples, the expandable structure includes apertures that are shaped, sized, and/or otherwise configured such that oblong electrodes that are mechanically coupled to the expandable structure can only be oriented in particular way relative to the expandable structure (e.g., such as to help error-proof the assembly process of electrodes being mechanically coupled to the expandable structure). Such orientation of the oblong electrodes can limit or prevent the oblong electrodes from physically interfering with each other (e.g., touching), even when the expandable structure is transformed into the delivery configuration (e.g., a radially compressed configuration) of the expandable structure. Docket No. A0012241W001

[0010] The use of oblong electrodes and the orientation of such oblong electrodes with respect to the expandable structure can enable the use of a relatively greater number of electrodes and/or enable each electrode to have a relatively greater conductive surface area (e.g., as compared to electrodes having other shapes, such as circles). Thus, a relatively greater number of electrodes and/or electrodes with a relatively higher surface area (e.g., as compared to electrodes having other shapes, such as circles) can be mechanically coupled to the expandable structure without inhibiting the ability of the expandable structure to be transformed to the delivery configuration due to physical interference between adjacent electrodes.

[0011] In some examples, the structural features of the expandable structure that facilitate mechanical coupling of the electrodes to the expandable structure are configured to limit or prevent movement (e.g., rotation) of the electrodes relative to the expandable structure. For example, in some examples, the expandable structure, the electrodes, and/or the structures that enable and/or facilitate mechanical coupling of the electrodes to the expandable structure (electrode attachment elements) include respective mating features that limit and/or prevent the electrodes (e.g., oblong electrodes) from moving (e.g., rotating) relative to the expandable structure. In some examples, the expandable structure defines apertures having a non-circular shape and configured to receive a mating noncircular portion of a crimp and/or other electrode attachment element, such that electrodes attached to the expandable structure via the non-circular apertures can only be oriented in a particular way relative to a surface of the expandable structure. By preventing movement (e.g., of rotation) of electrodes relative to the expandable structure, physical interference (e.g., touching) between adjacent electrodes disposed on the expandable structure can be limited or entirely avoided, which may otherwise limit the ability of the expandable structure from fully transforming to the delivery (e.g., radially compressed) configuration. Further, preventing contact between adjacent electrodes can limit or prevent electrical shorting via unwanted physical contact between two or more electrodes disposed on the expandable structure.

[0012] In some examples herein, the structural features that that enable and/or facilitate mechanical coupling of the electrodes to the expandable structure are configured orient the electrodes such that an electrically conductive surface of each respective electrode faces radially outward from the expandable structure. For example, in some examples, the expandable structure is configured to orient the electrodes to face radially outward (relative to a central longitudinal axis of the expandable structure) from the Docket No. A0012241W001 expandable structure with little or no possibility of the electrically conductive surface of each electrode being oriented radially inward, such as away from a blood vessel wall. Said another way, the system can bias transmissions of electrical signals to and/or sensing of signals from tissue surrounding blood vessel as compared to radially inward from the blood vessel wall. In this way, the system is configured to facilitate directional electrical stimulation therapy and/or directional sensing, such as in a direction radially outward from the expandable structure and/or a blood vessel and towards a blood vessel wall. [0013] By fixing the particular surface of each electrode that faces radially outward towards a vessel wall, the systems described in this disclosure may be relatively more efficient (e.g., in terms of power used and/or power lost) during electrical stimulation therapy and/or sensing, such as compared to other types of systems that do not fix or orient conductive surfaces in a particular direction. Further, the directional electrical stimulation facilitated by the electrode assemblies described herein can help direct electrical stimulation signals to a specific target tissue site to enhance therapy efficacy and reduce possible adverse side effects from stimulating unintended tissue sites (e.g., particular nerves or brain targets).

[0014] In some examples herein, the endovascular therapy system includes features and/or components configurated to electrically insulate the electrodes from the expandable structure (e.g., the frame of the expandable structure, which can include an electrically conductive material). For example, in some examples, an electrically insulative material is provided between at least a portion of the expandable structure and electrodes that limits or prevents unwanted electrical communication between the electrodes and the body of the expandable structure (e.g., as both the electrodes and the expandable structure can include an electrically conductive material). As unwanted electrical communication between the electrode and the expandable structure can lead to less energy delivered via respective electrodes to target tissue of a patient, limiting or preventing physical contact between the electrodes and the expandable structure can ensure that little or no electrical energy delivered via the electrode is lost due to contact with the expandable structure.

[0015] In some examples, the electrically insulative material includes an electrically insulative structure, which can limit and/or prevent physical contact between electrodes and the expandable structure as well as electrically insulate electrodes from the expandable structure. Limiting and/or preventing physical contact between each respective electrode and the body of the expandable structure (e.g., including physical Docket No. A0012241W001 contact between each respective electrode and struts of the expandable structure) can prevent unwanted electrical communication between each respective electrode and the expandable structure (e.g., such that the electrode and the expandable structure remain electrically isolated).

[0016] In some examples, a medical device is configured to delivery electrical stimulation and/or sense a patient parameter via the electrodes of the endovascular device. In some examples, as described more fully herein, the medical device is configured to be implanted within the patient for long-term (e.g., chronic) stimulation therapy and/or sensing. In some examples, as described more fully herein, the medical device is configured for more temporary (e.g., acute) stimulation therapy and/or sensing, such as to evaluate the effectiveness of stimulation therapy and/sensing. In such temporary application, the medical device can be configured to remain external to the patient.

[0017] In some examples, an endovascular medical device system includes an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure including an expandable frame defining one or more apertures, wherein the expandable structure defines a central longitudinal axis; and one or more electrodes, each electrode of the one or more electrodes mechanically coupled to the expandable structure via a respective aperture of the one or more apertures, wherein each electrode of the one or more electrodes defines a first maximum dimension in a first direction along the central longitudinal axis of the expandable structure and a second maximum dimension in a second direction transverse to the first direction, wherein the first maximum dimension is greater than the second maximum dimension, and wherein when each electrode of the one or more electrodes is mechanically coupled to the expandable structure via the respective aperture, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

[0018] In some examples, a method of using a medical device system includes introducing a medical device into vasculature of a patient, the medical device includes an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure including an expandable frame defining one or more apertures, wherein the expandable structure defines a central longitudinal axis; and one or more electrodes, each electrode of the one or more electrodes mechanically coupled to the expandable structure via a respective aperture of the one or more apertures, wherein each electrode of the one or more Docket No. A0012241W001 electrodes defines a first maximum dimension in a first direction along the central longitudinal axis of the expandable structure and a second maximum dimension in a second direction transverse to the first direction, wherein the first maximum dimension is greater than the second maximum dimension, and wherein when each electrode of the one or more electrodes is mechanically coupled to the expandable structure via the respective aperture, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure; and advancing the medical device until the one or more electrodes are at or near a target location in the vasculature of the patient.

[0019] In some examples, an endovascular medical device system includes an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure including an expandable frame defining one or more apertures, each aperture of the one or more apertures defining a non-circular shape, wherein the expandable structure defines a central longitudinal axis; one or more electrodes, each electrode of the one or more electrodes mechanically coupled to the expandable structure via a respective aperture of the one or more apertures; and an electrically insulative material positioned between at least one electrode of the one or more electrodes and the expandable structure; and one or more electrode fixation elements, each respective electrode fixation element configured to be received by a respective aperture of the expandable structure and configured to mechanically couple to a respective electrode of the one or more electrodes, wherein each electrode of the one or more electrodes defines a first maximum dimension in a first direction along the central longitudinal axis of the expandable structure and a second maximum dimension in a second direction transverse to the first direction, wherein the first maximum dimension is greater than the second maximum dimension, wherein when each electrode of the one or more electrodes is mechanically coupled to the expandable structure via the respective aperture, and wherein when the respective electrode fixation element is received by the respective aperture and mechanically coupled to the respective electrode of the one or more electrodes, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

[0020] The examples described herein may be combined in any permutation or combination.

[0021] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and Docket No. A0012241W001 advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG. l is a conceptual diagram illustrating an example endovascular therapy system including an endovascular device configured to deliver electrical stimulation therapy to a target tissue site of a patient and/or sense a patient parameter from an endovascular location.

[0023] FIG. 2 is a functional block diagram illustrating components of an example medical device of the endovascular therapy system of FIG. 1.

[0024] FIG. 3 A illustrates a distal portion of an example endovascular therapy system including an expandable structure and electrodes carried by the expandable structure.

[0025] FIG. 3B illustrates the distal portion of the example endovascular therapy system including the expandable structure of FIG. 3 A, illustrated without electrodes carried by the expandable structure.

[0026] FIG. 3C illustrates a distal portion of an example endovascular therapy system including conductor wires that collectively form a coil and that branch out from the coil to electrically connect to individual electrodes.

[0027] FIG. 3D illustrates an example electrode mechanically coupled to an example expandable structure.

[0028] FIG. 3E and FIG. 3F illustrate different views of a portion of an example expandable structure.

[0029] FIG. 3G and FIG. 3H illustrate a perspective view and a side view, respectively, of an example electrode.

[0030] FIG. 31, FIG. 31, and FIG. 3K illustrate a perspective view, a section view, and a side view, respectively, of an example electrode fixation element.

[0031] FIG. 3L illustrates a section view of an example electrically insulative structure.

[0032] FIG. 3M and FIG. 3N illustrate a perspective view and a section view, respectively, of an example crimp structure.

[0033] FIG. 4A and FIG. 4B illustrate an example expandable structure including electrodes carried by the expandable structure.

[0034] FIG. 5 A and FIG. 5B illustrate a perspective view and a section view, respectively, of an example crimp structure. Docket No. A0012241W001

[0035] FIG. 6 illustrates an example electrode mechanically coupled to an example expandable structure.

[0036] FIG. 7 is a flow diagram illustrating an example technique for introducing and advancing an endovascular device.

[0037] Like reference characters denote like elements throughout the description and figures.

DETAILED DESCRIPTION

[0038] This disclosure describes devices, systems, and methods relating to delivery of electrical stimulation therapy, such as vagus nerve stimulation (VNS) or deep brain stimulation (DBS), and/or sensing of one or more patient parameters (e.g., nerve activity from one more nerves, cardiac signals, muscle activation signals, brain signals and/or other physiological parameters, such as impedance, electroencephalogram (EEG), evoked potentials, local field potentials, and the like) from an endovascular location. Example endovascular locations that can be used for electrical stimulation therapy (e.g., VNS therapy) and/or sensing using the devices described herein include an internal jugular vein (IJV). Example endovascular locations that can be used to access brain sites for electrical stimulation therapy (e.g., DBS) and/or sensing using the devices described herein include any suitable cranial blood vessel (also referred to herein as a cerebral blood vessel or neurovasculature, which can include a vein or an artery), such as, but not limited to, the thalamostriate vein, the internal cerebral vein, the basal vein of Rosenthal, the inferior sagittal sinus, the superior sagittal sinus, or the anterior choroidal artery.

[0039] VNS has been proposed for use to manage one or more patient conditions, such as to control an inflammatory response in patients. Stimulating the vagus nerve may dampen the inflammatory response and associated cytokine response. In some examples, inflammatory cytokines are modulated up or down via stimulation. In addition, VNS may assist in stroke rehabilitation and limit ischemia reperfusion injury. After a myocardial infarct or stroke, reperfusion therapies (surgery or drugs) are given to restore blood flow. However, due to the restoration of blood, flow induced local damage may occur, including ischemia reperfusion injury. This injury may induce local accumulations of chemical mediators such as reactive oxygen species (ROS) production, inflammatory cytokines, bradykinin, etc., which can further affect inflammation. Such inflammatory compounds may trigger sensory signaling, which can lead to a reduced organ vagus Docket No. A0012241W001 activity and sympathetic overdrive. Vagus nerve stimulation may treat reperfusion damage as the inflammatory state may be lowered by increasing parasympathetic drive. [0040] DBS has been proposed for use to manage one or more patient conditions. For example, DBS can be used to alleviate, and in some cases eliminate, symptoms associated with movement disorders, other neurodegenerative impairment, seizure disorders, psychiatric disorders (e.g., mood disorders), or the like. Movement disorders may be found in patients with Parkinson’s disease, multiple sclerosis, and cerebral palsy, among other conditions, and can be associated with disease or trauma. DBS can be delivered to one or more target sites in a brain of a patient to help a patient with muscle control and minimize movement problems, such as rigidity, bradykinesia (i.e., slow physical movement), rhythmic hyperkinesia (e.g., tremor), nonrhythmic hyperkinesia (e.g., tics) or akinesia (i.e., a loss of physical movement).

[0041] In the case of seizure disorders, DBS can be delivered to one or more target sites in a brain of a patient to reduce the frequency or severity of seizures, or even help prevent the occurrence of seizures. In the case of psychiatric disorders, DBS can be delivered to help minimize or even eliminate symptoms associated with major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, or obsessive-compulsive disorder (OCD). DBS can also reduce the symptoms of Parkinson’s disease, dystonia, or cerebellar outflow tremor.

[0042] While this disclosure is primarily directed to examples of VNS and/or sensing via applicable endovascular locations (e.g., the internal jugular vein), it should be understood that the devices, systems, and techniques may be adapted for DBS, other kinds of brain stimulation, peripheral nerve stimulation, or electrical stimulation and/or sensing of any nerve tissue that can be done via an endovascular location.

[0043] In the examples described herein, an endovascular therapy system includes one or more electrodes and/or other sensing elements that are carried by an expandable structure at a distal portion of an elongated body of an endovascular device (e.g., a medical lead). The expandable structure (e.g., which can include a frame that includes a plurality of connected struts, such as a stent or stent-like structure or another expandable frame-like structure) is configured to transform between a delivery (e.g., relatively low- profile or compressed, including radially compressed) configuration and a deployed (e.g., expanded, including radially expanded) configuration. One or more electrodes and/or sensing elements are mechanically coupled to, disposed on, or otherwise carried by the expandable structure. Each electrode and/or sensing element is electrically connected to a Docket No. A0012241W001 medical device via one or more conductor wires. The medical device is configured to deliver therapy (e.g., electrical stimulation therapy) and/or received sensed signals via the electrodes or sensing elements by way of the conductor wires. The conductor wires can extend from the medical device, along (e.g., within) the elongated body of the endovascular device, and distal of the elongated body to electrically connect to each electrode or sensing element. While this disclosure primarily discusses electrodes attached to an expandable structure, one or more other sensing elements can additionally or alternatively be attached to the expandable structures described herein.

[0044] In some examples, the expandable structure and at least a portion of the endovascular device (e.g., the medical lead) are configured be introduced into and advanced within a blood vessel of a patient, such as to position the electrodes and/or sensing elements proximate a target location (e.g., proximate a location with target anatomical structures such as nerves or brain tissue proximate the blood vessel). For example, in some examples, the expandable structure and at a least a portion of the endovascular device (e.g., the medical lead) are configured to be delivered to the target location with the aid of an introducer sheath, a delivery catheter, or the like. A delivery (e.g., relatively low-profile or compressed, including radially compressed) configuration of the expandable structure can enable the expandable structure and/or a portion of the endovascular device (e.g., the medical lead) to be positioned within the introducer sheath and/or delivery catheter (e.g., within a lumen defined by the introducer sheath and/or delivery catheter).

[0045] In some examples herein, portions of the expandable structure include structural features that facilitate mechanical coupling of one or more electrodes to the expandable structure. In some examples, the expandable structure defines one or more apertures configured to enable and/or facilitate mechanical coupling the electrodes to the expandable structure. For example, in some examples, each aperture is sized, shaped, and/or otherwise configured to receive one or more structures (e.g., an electrode fixation element and/or a crimp structure) configured to mechanically couple a respective electrode to the expandable structure. Thus, because electrodes can be fabricated separately from the expandable structure, properties of electrodes (e.g., size, shape, conductive surface area) can be selected and/or adjusted during fabrication, manufacturing, and/or assembly for a particular end use, and the electrode assemblies can subsequently be attached to the expandable structure via the electrode attachment elements. Docket No. A0012241W001

[0046] In some examples, the structural features of the expandable structure that enable and/or facilitate mechanical coupling of the electrodes to the expandable structure are configured to orient the electrodes in a way such as to enable a relatively large size (e.g., a relatively large electrically conductive surface area) of each electrode while also limiting or preventing a possibility of physical interference between electrodes during transformation of the expandable structure between the delivery (e.g., radially compressed) configuration and the deployed (e.g., radially expanded) configuration. For example, in some examples, each electrode defines an oblong shape (e.g., having a first, longer dimension as measured in a first direction, which can be referred to as a major axis, and a second, shorter dimension as measured in a second direction, which can be referred to as a minor axis), and the longer dimension of the oblong shape extends along a longitudinal axis of the expandable structure when the oblong electrode is mechanically coupled to the expandable structure. In some examples, the structural features of the expandable structure that enable and/or facilitate mechanical coupling of the electrodes to the expandable structure are configured to orient each electrode such that the first, longer dimension of each oblong electrode is positioned in a first direction along a central longitudinal axis of the expandable structure and such that the second shorter dimension (e.g., that is less than the first dimension) of each oblong electrode is positioned transverse to the first direction. In some examples, the second direction is orthogonal to the first direction.

[0047] In some examples, the expandable structure includes apertures that are shaped, sized, and/or otherwise configured such that oblong electrodes that are mechanically coupled to the expandable structure can only be oriented in particular way relative to the expandable structure (e.g., such as to help error-proof the assembly process of electrodes being mechanically coupled to the expandable structure). Such orientation of the oblong electrodes can limit or prevent the oblong electrodes from physically interfering with each other (e.g., touching), even when the expandable structure is transformed into the delivery configuration (e.g., a radially compressed configuration) of the expandable structure. [0048] The use of oblong electrodes and the orientation of such oblong electrodes with respect to the expandable structure can enable the use of a relatively greater number of electrodes and/or enable each electrode to have a relatively greater conductive surface area (e.g., as compared to electrodes having other shapes, such as circles). Thus, a relatively greater number of electrodes and/or electrodes with a relatively higher surface area (e.g., as compared to electrodes having other shapes, such as circles) can be Docket No. A0012241W001 mechanically coupled to the expandable structure without inhibiting the ability of the expandable structure to be transformed to the delivery configuration due to physical interference between adjacent electrodes.

[0049] In some examples, the structural features of the expandable structure that facilitate mechanical coupling of the electrodes to the expandable structure are configured to limit or prevent movement (e.g., rotation) of the electrodes relative to the expandable structure. For example, in some examples, the expandable structure, the electrodes, and/or the structures that enable and/or facilitate mechanical coupling of the electrodes to the expandable structure (electrode attachment elements) include respective mating features that limit and/or prevent the electrodes (e.g., oblong electrodes) from moving (e.g., rotating) relative to the expandable structure. In some examples, the expandable structure defines apertures having a non-circular shape and configured to receive a mating noncircular portion of a crimp and/or other electrode attachment element, such that electrodes attached to the expandable structure via the non-circular apertures can only be oriented in a particular way relative to a surface of the expandable structure. By preventing movement (e.g., of rotation) of electrodes relative to the expandable structure, physical interference (e.g., touching) between adjacent electrodes disposed on the expandable structure can be limited or entirely avoided, which may otherwise limit the ability of the expandable structure from fully transforming to the delivery (e.g., radially compressed) configuration. Further, preventing contact between adjacent electrodes can limit or prevent electrical shorting via unwanted physical contact between two or more electrodes disposed on the expandable structure.

[0050] In some examples herein, the structural features that that enable and/or facilitate mechanical coupling of the electrodes to the expandable structure are configured orient the electrodes such that an electrically conductive surface of each respective electrode faces radially outward from the expandable structure. For example, in some examples, the expandable structure is configured to orient the electrodes to face radially outward (relative to a central longitudinal axis of the expandable structure) from the expandable structure with little or no possibility of the electrically conductive surface of each electrode being oriented radially inward, such as away from a blood vessel wall. Said another way, the system can bias transmissions of electrical signals to and/or sensing of signals from tissue surrounding blood vessel as compared to radially inward from the blood vessel wall. In this way, the system is configured to facilitate directional electrical Docket No. A0012241W001 stimulation therapy and/or directional sensing, such as in a direction radially outward from the expandable structure and/or a blood vessel and towards a blood vessel wall. [0051] By fixing the particular surface of each electrode that faces radially outward towards a vessel wall, the systems described in this disclosure may be relatively more efficient (e.g., in terms of power used and/or power lost) during electrical stimulation therapy and/or sensing, such as compared to other types of systems that do not fix or orient conductive surfaces in a particular direction. Further, the directional electrical stimulation facilitated by the electrode assemblies described herein can help direct electrical stimulation signals to a specific target tissue site to enhance therapy efficacy and reduce possible adverse side effects from stimulating unintended tissue sites (e.g., particular nerves or brain targets).

[0052] In some examples herein, the endovascular therapy system includes features and/or components configurated to electrically insulate the electrodes from the expandable structure (e.g., the frame of the expandable structure, which can include an electrically conductive material). For example, in some examples, an electrically insulative material is provided between at least a portion of the expandable structure and electrodes that limits or prevents unwanted electrical communication between the electrodes and the body of the expandable structure (e.g., as both the electrodes and the expandable structure can include an electrically conductive material). As unwanted electrical communication between the electrode and the expandable structure can lead to less energy delivered via respective electrodes to target tissue of a patient, limiting or preventing physical contact between the electrodes and the expandable structure can ensure that little or no electrical energy delivered via the electrode is lost due to contact with the expandable structure.

[0053] In some examples, the electrically insulative material includes an electrically insulative structure, which can limit and/or prevent physical contact between electrodes and the expandable structure as well as electrically insulate electrodes from the expandable structure. Limiting and/or preventing physical contact between each respective electrode and the body of the expandable structure (e.g., including physical contact between each respective electrode and struts of the expandable structure) can prevent unwanted electrical communication between each respective electrode and the expandable structure (e.g., such that the electrode and the expandable structure remain electrically isolated). Docket No. A0012241W001

[0054] In some examples, a medical device is configured to delivery electrical stimulation and/or sense a patient parameter via the electrodes of the endovascular device. In some examples, as described more fully herein, the medical device is configured to be implanted within the patient for long-term (e.g., chronic) stimulation therapy and/or sensing. In some examples, as described more fully herein, the medical device is configured for more temporary (e.g., acute) stimulation therapy and/or sensing, such as to evaluate the effectiveness of stimulation therapy and/sensing. In such temporary application, the medical device can be configured to remain external to the patient. [0055] FIG. 1 is a conceptual diagram illustrating an example therapy system 10 configured to deliver electrical stimulation therapy to a target tissue site of a patient 12 or sense a patient parameter from an endovascular location. Patient 12 ordinarily will be a human patient. In some cases, however, therapy system 10 is applied to other mammalian or non-mammalian non-human patients. Therapy system 10 includes a medical device 14 and an endovascular device 16. In the example shown in FIG. 1, medical device 14 is configured to deliver electrical stimulation therapy (e.g., VNS) to a vagus nerve 21 of patient 12 and/or sense bioelectrical signals via a plurality of electrodes 17. However, in other examples, therapy system 10 and/or medical device 14 is configured to deliver electrical stimulation therapy to other target sites in patient 12, such as, but not limited to brain 18 of patient 12 and/or sense bioelectrical brain signals in brain 18 via electrodes 17.

[0056] In the example of FIG. 1, endovascular device 16 is positioned in a jugular vein 13 of patient 12 such that one or more electrodes 17 are located proximate to a target tissue site. In particular, electrodes 17 are positioned to deliver electrical stimulation therapy to and/or sense signals from nerves surrounding jugular vein 13, including (but not limited to) vagus nerve 21. Endovascular device 16 includes an expandable structure 19 at a distal portion 15 of endovascular device 16 which may help hold electrodes 17 in apposition with a vessel wall (e.g., of jugular vein 13). In some examples, expandable structure 19 is mechanically coupled (e.g., directly mechanically coupled) to a portion of endovascular device 16 via a suitable mechanical connection (e.g., welding, crimped connection, or the like). Medical device 14 can provide electrical stimulation to one or more regions surrounding jugular vein 13 in order to manage a condition of patient 12, such as to mitigate the severity or duration of the patient condition.

[0057] Endovascular device 16 includes any suitable medical device configured to deliver electrical stimulation signals to tissue proximate electrodes 17. For example, Docket No. A0012241W001 endovascular device 16 can be a medical lead, a catheter, a guidewire, or another elongated body carrying electrodes 17 and configured to be electrically coupled to medical device 14 via an electrically conductive pathway (e.g., via one or more conductor wires) that runs between medical device 14 and electrodes 17. Endovascular device 16 has any suitable length that enables connection to medical device 14 either directly or indirectly, e.g., a length of 150 centimeters (cm) to 250 cm, such as 200 cm. Further, endovascular device 16 has a suitable length (e.g., as measured along a longitudinal axis of endovascular device 16) for accessing a target tissue site within the patient from a vascular access point. In examples in which endovascular device 16 accesses the jugular vein 13 and/or vasculature in a brain 18 of patient 12 from a femoral artery access point at the groin of the patient, endovascular device 16 has a length of about 100 cm to about 200 cm, although other lengths may be used. However, other access points may be used to introduce endovascular device 16 into vasculature of a patient, such as, but not limited to, a radial artery.

[0058] As used herein, “about” can indicate the exact value or nearly the exact value to the extent permitted by manufacturing tolerances. “About” can also refer to a certain percentage of the recited value (e.g., within about 1%, 5%, or 10%).

[0059] Endovascular device 16 is configured to be introduced in the vasculature of patient 12, such as to access a target tissue site. The vasculature can include any suitable blood vessel (e.g., a vein or an artery), e.g., jugular vein 13 and/or relatively more distal locations in a patient, such as the middle cerebral artery (MCA) in a brain of a patient. Endovascular device 16 may include an elongated body that is structurally configured to be relatively flexible, pushable, and relatively kink- and buckle-resistant, so that it may resist buckling when a pushing force is applied to a relatively proximal portion to advance endovascular device 16 distally through vasculature, and so that it may resist kinking when traversing around a tight turn in the vasculature. Kinking and/or buckling of may hinder a clinician’s efforts to push the elongated body distally, e.g., past a turn. In some examples, endovascular device 16 includes one or more radiopaque components (e.g., platinum bands) proximate electrodes 17 and/or expandable structure 19.

[0060] Instead of or in addition to the elongated body of endovascular device 16 being configured for intravascular navigation to a cerebral blood vessel to deliver electrical stimulation therapy or sense a patient parameter, endovascular device 16 can be navigated through vasculature (e.g., to jugular vein 13, brain 18, or other target tissue sites) with the aid of a guide member. The guide member can include an introducer Docket No. A0012241W001 sheath, an outer catheter, an inner catheter, a guide extension catheter, a guidewire, or the like or combination thereof.

[0061] In some examples, more than one of endovascular device 16 is introduced into, positioned in, and/or implanted within patient 12 to provide stimulation to and/or sense multiple anatomical regions, including one or more of both the left and right jugular veins, as well as in locations of brain 18. For example, two or more of endovascular device 16, which may be paired with one or more of medical device 14, may be configured of bilateral stimulation and/or sensing (e.g., of the left jugular vein and a right jugular vein). Endovascular device 16, including electrodes 17 and/or expandable structure 19, can be positioned in and/or implanted within a blood vessel for chronic therapy delivery and/or chronic sensing (e.g., on the order of months or even years) or for more temporary therapy delivery and/or sensing (e.g., on the order of days, such as less than a month or less than 6 months). Temporary therapy delivery may include one or more trial periods, such as to determine, evaluate, or confirm an efficacy of stimulation and/or sensing, and/or to select electrical stimulation parameters for chronic therapy delivery.

[0062] The electrical stimulation therapy described herein (e.g., VNS, DBS, or the like) may be used to treat various patient conditions, such as, a variety of illnesses including, but not limited to: reperfusion damage, cardiac ischemia, brain ischemia, stroke, traumatic brain injury, surgical or non-surgical acute kidney injury, inability of the intestine (bowel) to contract normally and move waste out of the body, postoperative ileus, postoperative cognitive decline or postoperative delirium, asthma, sepsis, bleeding control, myocardial infarction reduction, dysmotility, obesity, movement disorders, other neurodegenerative impairment, seizure disorders, and/or psychiatric disorders (e.g., mood disorders). Treating any of these diseases may improve patient outcomes by shortening length of hospital stays and reducing medical costs.

[0063] The vasculature into which endovascular device 16 may be inserted and/or guided includes, but is not limited to, veins or arteries. For example, endovascular device 16 can be navigated from a vasculature access site (e.g., in the femoral artery, the radial artery, or another suitable access site) to one or more of a jugular vein (e.g., internal jugular vein and/or external jugular vein), a carotid artery (e.g., internal carotid artery, external carotid artery, and/or common carotid artery), as well as brain targets including the thalamostriate vein, the internal cerebral vein, the basal vein of Rosenthal, the Docket No. A0012241W001 inferior/ superior sagittal sinus, the anterior choroidal artery, or any related combinations thereof.

[0064] A clinician can also select a particular blood vessel to position electrodes 17 within, such as to avoid certain regions to minimize or even eliminate adverse effects. For example, electrodes 17 can be oriented or positioned relative to vagus nerve 21 to avoid inadvertently providing electrical stimulation to anatomical regions (e.g., undesired anatomical regions) near the targeted anatomical region.

[0065] In some examples, endovascular device 16 is configured to be delivered to one or more target sites in vasculature of patient 12. Thus, rather than introducing endovascular device 16 into tissue in close proximity with vagus nerve 21 through an incision in the neck or chest area of patient 12, endovascular device 16 is configured to be navigated proximate to a target electrical stimulation site and/or sensing site via vasculature of patient 12. The endovascular delivery of endovascular device 16 to target sites can help minimize the invasiveness of therapy system 10.

[0066] In some examples, one or more electrodes 17 are positioned on (e.g., mechanically coupled to, defined by, or otherwise carried by) expandable structure 19 of endovascular device 16, which is configured to expand radially outwards from a relatively low-profile (e.g., radially compressed) delivery configuration to a deployed configuration. This may enable electrodes 17 to be held in apposition with a blood vessel wall, promote tissue ingrowth around electrodes 17 along the vessel wall (while still leaving a patent lumen to enable blood flow through the blood vessel, through expandable structure 19, despite implantation of endovascular device 16), which can reduce the overall power needed to deliver efficacious electrical stimulation therapy to a target tissue site, and help secure electrodes 17 in place in the blood vessel for chronic therapy delivery.

[0067] As described herein, expandable structure 19 can include structural features (e.g., apertures) that facilitate mechanical coupling of electrodes 17 to expandable structure 19. For example, expandable structure 19 (e.g., a body and/or frame of expandable structure 19) can define one or more apertures configured to receive a portion of one of electrodes 17 and/or another other structures that enable mechanical coupling of electrodes 17 to expandable structure 19. The structural features that enable mechanical coupling of electrodes 17 to expandable structure 19 can also help orient electrodes 17 relative to expandable structure 19 and/or prevent movement (e.g., rotation) or electrodes 17 relative to expandable structure 19. Docket No. A0012241W001

[0068] Medical device 14 can be an external medical device or an implantable medical device that includes electrical stimulation circuitry configured to generate and deliver electrical stimulation therapy to patient 12 and/or sensing circuitry configured to sense a patient parameter (e.g., a physiological signal) via one or more electrodes 17 of endovascular device 16. Electrodes 17, when activated by medical device 14, can be configured to deliver electrical stimulation and/or sense a patient parameter from an endovascular location. In the example shown in FIG. 1, endovascular device 16 is directly or indirectly mechanically and electrically coupled to medical device 14 via a header 11 of medical device 14, which defines a plurality of electrical contacts in one or more feedthroughs (e.g., that are configured to electrically couple electrodes 17 to electrical stimulation generation circuitry and/or sensing circuitry within medical device 14).

[0069] In some examples, therapy system 10 includes one or more conductor wires (not shown in FIG. 1) extending between medical device 14 and electrodes 17, the one or more conductor configured to carry electrical signals between medical device and electrodes 17 or vice versa. The conductor wires may extend along, be a part of, incorporated into, and/or integrally formed as part of endovascular device 16. In some examples, header 11 includes multiple feedthroughs, which may be respectively configured to receive one of multiple portions of endovascular device 16. Header 11 may also be referred to as a connector block or connector of medical device 14. Endovascular device 16 may be mechanically coupled and/or electrically coupled to header 11 with the aid of a lead extension. However, in some examples, a lead extension is not used between header 11 and endovascular device 16, and endovascular device is directly mechanically and/or electrically connected to medical device 14 via header 11.

[0070] In some examples, medical device 14 is configured to be positioned in (e.g., implanted in) patient 12 in any suitable location, such as a location in a pectoral region. In other examples, medical device 14 is configured to be external to patient 12.

Endovascular device 16 may be, for example, implanted within a vein (e.g., jugular vein 13) and one or more proximal wires/leads can remain within the venous system until they exit the venous system, such as through the subclavian vein in the chest or the internal jugular vein in the neck for implant in the pectoral region. In yet other examples, some or all of medical device 14 is configured to be implanted in the vasculature, e.g., as part of endovascular device 16.

[0071] As shown in FIG. 1, system 10 may also include a programmer 20, which may be a handheld device, portable computer, or workstation that provides a user interface to a Docket No. A0012241W001 user, for example a clinician or other user, such as a patient. The user may interact with the user interface to program electrical stimulation parameters for medical device 14. [0072] With the aid of programmer 20 or another computing device, a clinician may select values for therapy parameters for controlling therapy delivery by therapy system 10. The values for the therapy parameters may be organized into a group of parameter values referred to as a “therapy program” or “therapy parameter set.” “Therapy program” and “therapy parameter set” are used interchangeably herein. In the case of electrical stimulation, the therapy parameters may include a combination of activated electrodes 17 (also referred to herein as an electrode combination), a power, and an amplitude, which may be a current or voltage amplitude, and, if medical device 14 delivers electrical pulses, a pulse width, and a pulse rate for stimulation signals to be delivered to the patient. Other example therapy parameters include a slew rate, duty cycle, and phase of the electrical stimulation signal.

[0073] An electrode combination may include a selected subset of one or more electrodes 17 located on one or more of endovascular devices 16 mechanically coupled and/or electrically coupled to medical device 14. The electrode combination may also refer to the polarities of the electrodes in the selected subset. By selecting particular electrode combinations (e.g., of activated ones of electrodes 17), a user may target particular tissue sites (e.g., anatomic structures) within patient 12 and/or avoid particular tissue sites. In addition, by selecting values for other electrical stimulation parameter values, such as slew rate, duty cycle, phase amplitude, pulse width, and/or pulse rate, the user can attempt to generate an efficacious therapy for patient 12 that is delivered via the selected electrode subset.

[0074] Whether programmer 20 is configured for clinician or patient use, programmer 20 may be configured to communicate with medical device 14 or any other computing device via wireless or a wired communication. Programmer 20, for example, may communicate via wireless communication with medical device 14 using radio frequency (RF) telemetry techniques. Programmer 20 may also communicate with another programmer or computing device via a wired or wireless connection using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared communication according to the Infrared Data Association (IRDA) specification set, or other standard or proprietary telemetry protocols. Programmer 20 may also communicate with another programming or computing device via a wired or wireless communication technique. Docket No. A0012241W001

[0075] In some examples, in addition to or instead of delivering electrical stimulation to a target location (e.g., vagus nerve 21), medical device 14 or another device is configured to sense one or more patient parameters, such as bioelectric signals, either using electrodes 17 or other types of sensing elements that are carried by endovascular device 16. Bioelectric signals (also referred to herein as bioelectrical signals) can be sensed, and indications of sensed signals can be used by clinicians to make clinically relevant decision. In other examples, sensed bioelectric signals are used as part of continuous feedback system in which medical device 14 adjusts (e.g., in a closed-loop or pseudo-closed-loop manner) one or more therapy parameter values (e.g., for electrical stimulation therapy) based on sensed bioelectrical signals. Example bioelectric signals are described in further detail below with reference to FIG. 2.

[0076] In some examples, medical device 14 is configured to generate and deliver a suitable electrical stimulation signal, which can be a continuous time signal (e.g., a sinusoidal waveform or the like) or a plurality of pulses. In some examples, the electrical stimulation waveform generated by medical device 14 and delivered by one or more of electrodes 17 is a charge balanced, biphasic waveform. In some examples, such an electrical stimulation waveform consists of periodic pulses or otherwise include periodic pulses, or can include a continuous time waveform.

[0077] As noted above, in some examples, one or more electrodes 17 are positioned on expandable structure 19. In some examples, one or more sensing elements that are different from electrodes 17 are positioned on the same expandable structure (e.g., expandable structure 19) as one or more electrodes 17 or on a different expandable structure (e.g., a structure similar to or different from expandable structure 19) of endovascular device 16. Expandable structure 19 can have any suitable configuration that enables endovascular device 16 to assume a relatively low-profile configuration (also referred to herein as a “delivery” or “compressed” configuration in some examples) to facilitate delivery through vasculature to a target tissue site and expand radially outwards (relative to a central longitudinal axis of endovascular device 16) to position the one or more electrodes 17 closer to target tissue.

[0078] In some examples, expandable structure 19 is configured to expand radially outwards with sufficient force and to a cross-sectional dimension (e.g., a diameter) sufficient to position the one or more electrodes 17 in apposition with a blood vessel wall. Positioning one or more electrodes 17 in apposition with a blood vessel wall may help promote tissue ingrowth around electrodes 17, which can reduce the impedance and the Docket No. A0012241W001 overall power needed to deliver efficacious electrical stimulation therapy to a target tissue site, and help secure electrodes 17 in place in the blood vessel for chronic (e.g., on the order of months or even years) therapy delivery. Fixing endovascular device 16 in place within the blood vessel via the tissue ingrowth or, in some examples, using another fixation structures/anchoring mechanisms, such as tines, coils, barbs, or the like, can also help reduce the possibility of thrombosis.

[0079] Expandable structure 19 can be configured to expand radially outwards using any suitable technique and configuration. In some examples, expandable structure 19 includes a shape memory (e.g., nitinol) material that enables expandable structure 19 to assume a predetermined shape in the absence of a force (e.g., a compressive or tensile force) holding expandable structure 19 in a relatively low-profile delivery configuration. For example, in some examples, expandable structure 19 is configured to expand (e.g., self-expand) radially outwards upon deployment from an outer sheath (e.g., an outer catheter), or upon the proximal withdrawal of a straightening element (e.g., a guidewire, an obturator, and/or a mandrel) positioned in an inner lumen of the endovascular device 16. In some examples, expandable structure 19 is configured to expand radially outwards in response to proximal movement of a pull member attached to a distal portion of the endovascular device 16, in response to a distal movement of an elongated control member attached to the expandable structure, or with the aid of a balloon or the like.

[0080] Expandable structure 19 can have any suitable configuration in its deployed (e.g., expanded) configuration. In some examples herein, expandable structure 19 includes an expandable frame. In some examples, the expandable frame includes a plurality of connected struts to form a structure (e.g., a tubular structure with a tubular body) configured to expand radially outward (e.g., from a central longitudinal axis of expandable structure 19). For example, expandable structure 19 can include a tubular member, a basket, include one or more splines or arms configured to expand radially outwards, define one or more loops, define a helical or spiral element, or the like or combinations thereof, when in the deployed configuration. One or more expandable structures 19 may be disposed at various positions along endovascular device 16 (e.g., at one or more longitudinal positions along endovascular device 16). Expandable structure 19 can be formed from a plurality of structural elements (e.g., braided or mechanically coupled together) or can be a unitary structure (e.g., a laser cut nitinol tube). In some examples, expandable structure 19 is referred to herein as having a stent-like structure. Docket No. A0012241W001

[0081] Expandable structure 19 can be mechanically coupled to a portion of endovascular device 16 (e.g., distal portion 15 of endovascular device 16). In some examples, expandable structure 19 is mechanically coupled to endovascular device 16 via a welded connection, a crimped connection, a bonded connection (e.g., via an adhesive and/or another suitable bonding agent), or another suitable mechanical connection.

[0082] In addition to, or instead of, chronic therapy delivery and/or chronic sensing, example devices, systems, and methods described herein can be used for more temporary applications. In some examples, a first endovascular device (e.g., configured like endovascular device 16 or having another configuration) is configured to be operated in an acute (e.g., temporary) trial mode for a trial period to determine, evaluate, or confirm an efficacy of stimulation and/or sensing. For example, endovascular device 16 (as well as electrodes 17, medical device 14, processing circuitry, etc.) may be configured to operate in the trial mode to determine the efficacy of one or more stimulation parameter values and/or one or more sensing parameters. After the acute trial period, the first endovascular device may be removed, and a second endovascular device (e.g., configured like endovascular device 16 or having another configuration) configured to operate in a chronic mode may be implanted for a chronic period for chronic (e.g., long term, or permanent) stimulation therapy or sensing. In some examples, a first endovascular device (e.g., for use in the acute trial mode) is configured to be implanted and subsequently removed after the trial period.

[0083] A trial period has a shorter intended duration as compared to a chronic period, though the ultimate length of the chronic period may be less than an intended duration due to one or more factors, such as a patient response that requires shortening the chronic period relative to the intended duration of the chronic period. In some examples, the trial period includes a trial period length on the order of minutes (e.g., 1 minute, 2 minutes, 3 minutes, 5 minutes, 30 minutes, 45 minutes, etc.), on the order of hours (e.g., 1 hour, 2 hours, 5 hours, 12 hours, etc.), on the order of days (e.g., 1 day, 2 days, 3 days, etc.), on the order of weeks (e.g., 1 week, 2 weeks, 3 weeks, etc.) on the order of months (e.g., 1 month, 2 months, 3 months, etc.), or longer. In some examples, one or more of endovascular devices may be used for multiple trial periods (e.g., successive trial periods) for determining an efficacy of one or more stimulation parameters and/or one or more sensing parameters.

[0084] Therapy system 10 may have any suitable configuration for delivering electrical stimulation to a target tissue site in patient 12 or sensing a patient parameter Docket No. A0012241W001 from an endovascular location (e.g., jugular vein 13). In some examples, therapy system 10 includes a first subset of electrodes of electrodes 17 configured for delivering electrical stimulation therapy and a second subset of electrodes of electrodes 17 configured for sensing one or more patient parameters. In some examples, some or all electrodes of electrodes 17 are configured for both electrical stimulation therapy and for sensing one or more patient parameters. Therapy system 10 can include any suitable number of electrodes 17 (e.g., one electrode, two electrodes, three electrodes, four electrodes, five electrodes, six electrodes, seven electrodes, eight electrodes, nine electrodes, ten electrodes, or more) and/or combination of different kinds of electrodes. In some examples, electrodes 17 include electrodes formed via one or more manufacturing processes. For example, electrodes 17 can include a first electrode type (e.g., an electrode configured for delivery of electrical stimulation therapy), a second electrode type (e.g., an electrode configured to sensing a signal), or any suitable combination thereof.

[0085] FIG. 2 is a functional block diagram illustrating components of an example medical device 14, which is configured to generate and deliver electrical stimulation therapy to patient 12 and, in some examples, sense one or more patient parameters, such as bioelectrical signals or other physiological parameter of patient 12. Medical device 14 includes processing circuitry 30, memory 32, therapy generation circuitry 34, sensing circuitry 36, telemetry circuitry 38, and power source 40.

[0086] Therapy generation circuitry 34 includes any suitable configuration (e.g., hardware) configured to generate and deliver electrical stimulation signals to target tissue (e.g., vagus nerve 21) in patient 12. Processing circuitry 30 is configured to control therapy generation circuitry 34 to generate and deliver electrical stimulation therapy via electrodes 17 of endovascular device 16. The therapy parameter values may be selected based on the patient condition being addressed, as well as the target tissue site in patient 12 for the electrical stimulation therapy. The electrical stimulation therapy can be provided via stimulation signals of any suitable form, such of stimulation pulses or continuous-time signals (e.g., sine waves).

[0087] Sensing circuitry 36 is configured to sense a physiological parameter of a patient. Sensing circuitry 36 may include any sensing hardware configured to sense a physiological parameter of a patient, such as, but not limited to, one or more electrodes, optical receivers, pressure sensors, or the like. The one or more sensing electrodes can be the same or different from electrodes 17 configured to deliver electrical stimulation therapy. In some examples, processing circuitry 30 stores the sensed physiological Docket No. A0012241W001 parameters in memory 32 or transmits the sensed parameters to another device via telemetry circuitry 38. In addition, in some examples, processing circuitry 30 can use the sensed physiological signals to control therapy delivery by therapy generation circuitry 34, e.g., the timing of the therapy delivery or one or more characteristics (e.g., parameters values) of the electrical simulation signal generated by therapy generation circuitry 34. [0088] In some examples, sensing circuitry 36 is configured to sense a bioelectrical signal, which otherwise may be referred to as a patient parameter, via one or more electrodes 17 (e.g., all or a subset of electrodes 17). Thus, electrodes 17 can be configured to receive or transmit energy (e.g., current). In some examples, such as those in which electrodes 17 are placed proximate vagus nerve 21 (FIG. 1), example bioelectrical signals include muscle activation signals (e.g., laryngeal muscle activation), electrocardiogram (ECG), intracardiac electrogram (EGM), electromyogram (EMG). In other examples, such as those in which electrodes 17 are placed in or otherwise proximate brain 18, example bioelectrical signals include brain signals such as an EEG signal, an electrocorti cogram (ECoG) signal, a signal generated from measured field potentials within one or more regions of brain 18, action potentials from single cells within brain 18 (referred to as “spikes”), or evoked potentials. Determining action potentials of single cells within brain 18 may require resolution of bioelectrical signals to the cellular level and provides fidelity for fine movements, i.e., a bioelectrical signal indicative of fine movements (e.g., slight movement of a finger).

[0089] In examples in which endovascular device 16 is configured to sense an evoked potential, endovascular device 16 may also be configured to generate a stimulus (e.g., via therapy generation circuitry 34, alone or in combination with processing circuitry 30) to elicit the evoked potential. For example, endovascular device 16 can generate and deliver electrical stimulation to tissue in brain 18 and sense an evoked compound action potential (ECAP). An ECAP is synchronous firing of a population of neurons which occurs in response to the application of a stimulus including, in some cases, an electrical stimulus by endovascular device 16. The ECAP may be detectable as being a separate event from the stimulus itself, and the ECAP may reveal characteristics of the effect of the stimulus on the tissue.

[0090] In some examples, sensing circuitry 36 and/or processing circuitry 30 includes signal processing circuitry configured to perform any suitable analog conditioning of the sensed physiological signals. For example, sensing circuitry 36 may communicate to processing circuitry 30 an unaltered (e.g., raw) signal. Processing circuitry 30 may be Docket No. A0012241W001 configured to modify a raw signal to a usable signal by, for example, filtering (e.g., low pass, high pass, band pass, notch, or any other suitable filtering), amplifying, performing an operation on the received signal (e.g., taking a derivative, averaging), performing any other suitable signal conditioning (e.g., converting a current signal to a voltage signal), or any combination thereof. In some examples, the conditioned analog signals are processed by an analog-to-digital converter of processing circuitry 30 or other component to convert the conditioned analog signals into digital signals. In some examples, processing circuitry 30 operates on the analog or digital form of the signals to separate out different components of the signals. In some examples, sensing circuitry 36 and/or processing circuitry 30 performs any suitable digital conditioning of the converted digital signals, such as low pass, high pass, band pass, notch, averaging, or any other suitable filtering, amplifying, performing an operation on the signal, performing any other suitable digital conditioning, or any combination thereof. Additionally or alternatively, sensing circuitry 36 may include signal processing circuitry to modify one or more raw signals and communicate to processing circuitry 30 one or more modified signals.

[0091] In some examples, processing circuitry 30, alone or in combination with therapy generation circuitry 34 and/or sensing circuitry 36, is configured to operate medical device 14 (including electrodes 17, endovascular device 16, etc.) in a trial mode for a trial period to determine an efficacy of electrical stimulation or sensing. As described above, a trial mode can include a trial period of stimulation and/or sensing to determine, evaluate, or confirm an efficacy of stimulation and/or sensing. In some examples, processing circuitry 30, alone or in combination with therapy generation circuitry 34 and/or sensing circuitry 36, is configured to deliver electrical stimulation therapy and/or sense a patient parameter during the trial period. In some examples, processing circuitry 30 is configured to determine, evaluate, or confirm an efficacy of stimulation and/or sensing. For example, processing circuitry 30 may determine one or more therapy parameters for chronic stimulation and/or sensing based on the trial period. [0092] Although shown as part of medical device 14 in FIG. 2, in other examples, sensing circuitry 36 is part of a device separate from medical device 14. For example, sensing circuitry 36 can be part of an implantable sensing device implanted in patient 12. [0093] Processing circuitry 30, as well as other processors, processing circuitry, controllers, control circuitry, and the like, described herein, may include any combination of integrated circuitry, discrete logic circuity, analog circuitry, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits Docket No. A0012241W001

(ASICs), or field-programmable gate arrays (FPGAs). In some examples, processing circuitry 30 includes multiple components, such as any combination of one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry, and/or analog circuitry.

[0094] Memory 32 is configured to store program instructions, such as software, which may include one or more program modules, which are executable by processing circuitry 30. When executed by processing circuitry 30, such program instructions may cause processing circuitry 30 to provide the functionality ascribed to processing circuitry 30 herein. The program instructions may be embodied in software and/or firmware. Memory 32 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media.

[0095] Processing circuitry 30 is configured to control telemetry circuitry 38 to send and receive information. Telemetry circuitry 38, as well as telemetry modules in other devices described herein, such as programmer 20 (FIG. 1), may accomplish communication by any suitable communication techniques, such as RF communication techniques. In addition, telemetry circuitry 38 may communicate with external medical device programmer 20 via proximal inductive interaction of medical device 14 with programmer 20. Accordingly, telemetry circuitry 38 may send information to external programmer 20 on a continuous basis, at periodic intervals, or upon request from medical device 14 or programmer 20.

[0096] Power source 40 is configured to deliver operating power to various components of medical device 14. Power source 40 may include a small rechargeable or non-rechargeable battery and a power generation circuit to produce the operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within medical device 14. In some examples, power requirements may be small enough to allow medical device 14 to utilize patient motion and implement a kinetic energy-scavenging device to trickle charge a rechargeable battery. In other examples, traditional batteries may be used for a limited period of time.

[0097] In some examples, endovascular device 16 is configured to be a standalone electrical stimulation device and can include one or more elements of medical device 14 shown in FIG. 2. Docket No. A0012241W001

[0098] FIG. 3 A and FIG. 3B illustrate partially schematic views of an example endovascular therapy system 100, which is an example of therapy system 10 of FIG. 1. Endovascular therapy system 100 includes a medical lead 160 and an expandable structure 190 at a distal portion 150 of medical lead 160. As shown in FIG. 3 A, endovascular therapy system 100 includes at least electrode 170A, electrode 170B, electrode 170C, electrode 170D, electrode 170E, and electrode 170F, collectively referred to herein as plurality of electrodes 170 and/or array of electrodes 170. Medical lead 160, expandable structure 190, distal portion 150, and electrodes 170 are examples of endovascular device 16, expandable structure 19, distal portion 15, and electrodes 17 of FIG. 1, respectively. FIG. 3B illustrates the example expandable structure 190 and medical lead 160 of FIG. 3 A, but with electrodes 170, as well as some other elements illustrated in FIG. 3 A, omitted for clarity.

[0099] FIG. 3C illustrates a partially schematic representation of portions of endovascular therapy system 100 (e.g., of FIG. 3A), including medical lead 160, expandable structure 190 at a distal portion 150 of medical lead 160, and a plurality of conductor wires 166 electrically connected to respective electrodes 170.

[0100] FIG. 3D illustrates a cross-sectional detail view of electrode 170A and a portion of expandable structure 190 including at least one of struts 192, the cross-section taken through a plane parallel to the x-axis and y-axis according to the orthogonal x-y-z axes shown in FIG. 3C and through a radial center of at least electrode 170A. The detailed view of FIG. 3D includes a portion of endovascular therapy system 100 enclosed by dashed lines labeled as “A” in the example of FIG. 3C. The example of FIG. 3D illustrates one manner in which electrode 170A can be mechanically coupled to expandable structure 190; in some examples, other electrodes 170A-170F (e.g., each electrode 170A-170F) of endovascular therapy system 100 can be mechanically coupled to expandable structure 190 in a similar manner as electrode 170A. As discussed herein, FIG. 3D generally illustrates an assembly of various components configured to enable and/or facilitate mechanical of coupling electrode 170A to expandable structure 190 and/or electrically insulating at least electrode 170A from expandable structure 190.

[0101] In the example of FIG. 3D, electrode 170A is mechanically coupled to (e.g., fixedly connected to) expandable structure 190 via an electrode attachment element 180 extending through an aperture 193 of expandable structure 190. A crimp structure 168 electrically connects a conductor wire 166A to electrode 170A. An electrically insulative structure 175 is positioned between at least a portion of electrode 170 and expandable Docket No. A0012241W001 structure 190 (e.g., to electrically insulate electrode 170 from expandable structure 190). While each of the components described in FIG. 3D are described as separate (e.g., physically separate) components, it is understood that one or more of such components, in other examples, can be integral components.

[0102] FIG. 3E, FIG. 3F, FIG. 3G, FIG. 3H, FIG. 31, FIG. 3J, FIG. 3K, FIG. 3L, FIG. 3M, and FIG. 3N illustrate various views of examples of different components of the assembly shown in FIG. 3D. In particular, FIG. 3E and FIG. 3F illustrate a portion of an example expandable structure 190, including one of struts 192 defining an aperture 193. FIG. 3G and FIG. 3H illustrate an example electrode 170A according to some examples of this disclosure. FIG. 31, FIG. 3J, and FIG. 3K illustrate various views of an example electrode fixation element 180. FIG. 3L illustrates a cross-sectional view of an example insulative structure 175. FIG. 3M and FIG. 3N illustrate a perspective view and a cross- sectional view respectively of an example crimp structure 168 (e.g., which can be mechanically coupled and/or electrical coupled to conductor wire 166A).

[0103] Medical lead 160, illustrated in FIG. 3A, FIG. 3B, and FIG. 3C, can have any suitable configuration, and may be configured according to the description of endovascular device 16 of FIG. 1. In some examples, medical lead 160 includes an elongated body (e.g., a tubular body defining a lumen) extending between an elongated body proximal end (not show in the examples of FIG. 3 A, FIG. 3B, and FIG. 3C) and an elongated body distal end 164.

[0104] In some examples, medical lead 160 includes a suitable biocompatible polymer material. For example, medical lead 160 can include a thermoplastic material, such as Polycarbonate Urethane (PCU). In some examples, medical lead additionally or alternatively includes one or more of Polyurethane (PUR or PU), Polyethylene (PE), Polypropylene (PP), Polyetheretherketone (PEEK), Polyphenyl sulfone (PPSU or PPSF), Polypropylene (PP), Nylon, Polyester, Polyethlene Terephthalate (PET), Polymethyl Methacrylate (PMMA), Polysulfone (PSU), and/or another suitable material.

[0105] In some examples, medical lead 160 is configured to be at least partially introduced into, positioned in, and/or implanted within vasculature (e.g., blood vessel) of patient 12. In some examples, medical lead 160 includes an electrically insulative material covering at least some portions of medical lead 160 (e.g., one of the materials listed above). The electrically insulative material covering at least some portions of medical lead 160 can electrically insulate elements disposed within medical lead 160 (e.g., electrically insulate electrically conductive components, such as conductor wires Docket No. A0012241W001

166, from blood or other tissue, such as when medical lead 160 is positioned in or advanced through a blood vessel of patient 12).

[0106] Expandable structure 190, illustrated at least in FIG. 3 A and FIG. 3B, is an example of expandable structure 19 as discussed in connection with FIG. 1. In some examples, expandable structure 190 (e.g., a proximal portion of expandable structure 190) is mechanically coupled to medical lead 160 (e.g., at a distal portion of medical lead 160). Expandable structure 190 can have any suitable configuration for positioning electrodes 170 for delivering stimulation therapy and/or sensing one or more patient parameters of patient 12 from an endovascular location. In some examples, as shown in FIG. 3A and FIG. 3B, expandable structure 190 includes a tubular body portion extending between an expandable structure proximal end 190A and an expandable structure distal end 190B. In some examples, expandable structure 190 defines a central longitudinal axis 111 (e.g., such that central longitudinal axis 111 extends through a radial center of expandable structure 190 from expandable structure proximal end 190A to expandable structure distal end 190B).

[0107] In some examples, as shown in the FIG. 3 A and FIG. 3B, expandable structure 190 includes a plurality of connected struts 192. In some examples, struts 192 are connected such as to form a frame (e.g., such that expandable structure 190 can be considered to include a frame). In some examples, expandable structure 190 defines a lumen 195. In some examples, struts 192 are connected to form the tubular (e.g., stentlike) structure (e.g., with the frame of expandable structure 190 extending around and forming lumen 195). In some examples, as illustrated at least in FIG. 3D, at least some of struts 192 (e.g., one or more struts 192, such as each strut 192) of expandable structure 190 defines a first face 194A (e.g., which can be considered a radially inward face of expandable structure 190) and a second face 194B (e.g., which can be considered a radially outward face of expandable structure 190) opposite first face 194B. As illustrated in FIG. 3E, each of apertures 193 extends entirely though a strut 192 (e.g., from first face 194 A to second face 194B).

[0108] In the example of FIG. 3 A, therapy system 100 includes a plurality of conductor wires 166 (shown individually in FIG. 3 A as conductor wire 166A, conductor wire 166B, conductor wire 166C, conductor wire 166D, conductor wire 166E, and conductor wire 166F, but collectively referred to herein as plurality of conductor wires 166), wherein each conductor wire 166A-166F is configured to electrically connect to one or more of electrodes 170, such as to electrically connect one or more of electrodes Docket No. A0012241W001

170 to a medical device (e.g., medical device 14 of FIG. 1). Each of conductor wires 166 can extend along (e.g., within) at least a portion of medical lead 160. In some examples, some or all of conductor wires 166 are part of medical lead 160, while in other examples, some or all of conductor wires 166 are separate components from medical lead 160. [0109] In some examples, at least a portion of each of conductor wires 166 are housed by the insulative material of medical lead 160. For example, each of conductor wires 166 can extend within a lumen of medical lead 160. In some examples, electrically insulative material of medical lead 160 is configured to electrically insulate portions of conductor wires 166 that run along the length of medical lead 160. As shown in the example of FIG. 3A, each of conductor wires 166 can extend distally of medical lead 160 (e.g., distally of elongated body distal end 164 of medical lead 160), such as to branch out to mechanically connect and/or electrically connect to one or more of electrodes 170. In some examples, each of conductor wires 166 extends along at least a portion of expandable structure 190. In some examples, at least a portion of each of conductor wires 166 extend within lumen 195 of expandable structure 190.

[0110] In some examples, some or all of conductor wires 166 include a material or combination of materials configured to facilitate relatively high flexibility, high axial extensibility, and/or high fatigue resistance. For example, one or more wires of conductor wires 166 includes a beta-titanium alloy. In some examples, the beta-titanium alloy comprises a Ti-15Mo alloy. Certain beta-titanium alloys, including Ti-15Mo alloy and similar titanium alloys enable use of a relatively greater number of conductor wires 166 (e.g., six or more wires), such as for situations in which a relatively high number of individually controlled electrodes are needed in a small space including nerve stimulation and/or sensing from endovascular locations. In some examples, one or more of conductor wires 166 includes a core material (e.g., a core at a radial center of each wire). The core material can be configured to provide radiopacity and/or reduced resistivity. In some examples, the core material includes tantalum.

[oni] Each of conductor wires 166 can individually and/or collectively be configured to maintain mechanical robustness (e.g., avoid fatigue), even during navigation of endovascular therapy system 100 through vasculature of patient 12, deployment of expandable structure 190, and/or long-term or short-term implantation in the presence of blood in vasculature of patient 12. In some examples, as illustrated in the example of FIG. 3C, at least a portion of conductor wires 166 form a multi-wire coil 167. By forming multi -wire coil 167, individual conductor wires 166 may be relatively less Docket No. A0012241W001 prone to mechanical fatigue during bending, axial extension, axial compression, and/or other forces applied to conductor wires 166 (e.g., as compared to examples in which conductor wires 166 do not form multi -wire could 167). In some examples, multi -wire coil 167 extends along at least a portion of medical lead 160 (e.g., the elongated body of medical lead 160). In some examples, as shown in the example of FIG. 3C, multi -wire coil 167 extends distally of elongated body distal end 164 of medical lead 160. In some examples, multi-wire coil 167 extends distally expandable structure proximal end 190A of expandable structure 190 (e.g., such that a portion of multi -wire coil 167 extends into and resides within expandable structure lumen 195 defined by expandable structure 190). [0112] As shown in the example of FIG. 3C, at least a subset of conductor wires 166 branch out from multi -wire coil 167 to respective electrodes of electrodes 170 (e.g., to electrically connect to the respective electrodes of electrodes 170). By maintaining the coil form-factor of multi -wire coil 167 to a relatively distal location (e.g., at least distally of expandable structure proximal end 190 A), conductor wires 166 can be less prone to fatigue as compared to other systems in which conductor wires 166 branch out to connect to individual electrodes 170 proximal to or at the junction of medical lead 160 and expandable structure 190.

[0113] In some examples, conductor wires 166 include one or more outer layers, e.g., coatings. In some examples, a coating applied to conductor wires 166 includes one or more of an antithrombotic (also referred to as antithrombogenic) coating (e.g., to prevent or eliminate the incidence of thrombosis), an electrically insulative coating, a slip coat (e.g., hydrophilic coating), or a suitable combination thereof.

[0114] In some examples, each of conductor wires 166 are electrically connected to respective electrode electrodes 170A-170F. In some examples, each of electrodes 170A- 170F is configured to receive and/or otherwise mechanically couple to one or more conductor wires of conductor wires 166 (e.g., to facilitate the electrical connection between each of conductor wires 166 and one or more of electrodes 170). For example, each of electrodes 170A-170F can include structural features that enable and/or facilitate contact (e.g., direct contact or indirect contact) with at least one of each of electrodes 170A-170F. An example of a structural feature is shown in the example of FIG. 3G and FIG. 3H, which illustrates electrode 170A (e.g., which can be an example of each of electrodes 170A-170F) defines a hole 173 configured to receive one of conductor wires 166 (and/or crimp structure 168 connected to one of conductor wires 166). In some Docket No. A0012241W001 examples, hole 173 enables electrode 170A to electrically couple to one of conductor wires 166, and thus also to a medical device (e.g., medical device 14 of FIG. 1).

[0115] In some examples, as shown in FIG. 3G and FIG. 3H, hole 173 extends entirely though electrode 170A. In some examples, hole 173 extends only partially though electrode 170A (e.g., as a blind hole). In other examples, as discussed more fully with respect to FIG. 6, each of electrodes 170A-170F do not define holes. In some examples, each of each of electrodes 170A-170F includes an electrical contact portion configured to facilitate electrical connection to a respective one of conductor wires 166.

[0116] In some examples, more than one of electrodes 170 are electrically connected to a common conductor wire of conductor wires 166 (e.g., some of electrodes 170 can be “shorted” together). For example, one of conductor wires 166 can be configured to connect to a least a first electrode and a second electrode of electrodes 170 (e.g., such that medical device 14 can simultaneously control each of the first electrode and the second electrode of electrodes 170 together). Shorting of at least some of electrodes 170 can facilitate control of multiple electrodes at the same time (e.g., for delivery of electrical stimulation therapy and/or sensing).

[0117] In some examples, electrodes 170 are carried by expandable structure 190, and expandable structure 190 is configured to position and/or orient electrodes 170 within vasculature of patient 12. In some examples, at least some of electrodes 170 are carried by and/or mechanically connected to respective struts 192 of expandable structure 190. In some examples, electrodes 170 are carried by and/or disposed on expandable structure 190, and expandable structure 190 is configured to transform from a relatively low-profile delivery configuration to a deployed (e.g., expanded) configuration in a blood vessel of a patient (e.g., within jugular vein 13 of patient 12 as discussed in relation to FIG. 1 and/or within a cranial blood vessel of patient 12). In the deployed configuration, expandable structure 190 can be configured to position the electrodes 170 to deliver electrical stimulation to tissue or sense a patient parameter from a location within a blood vessel. [0118] In some examples, expandable structure 190 is configured to expand (e.g., self-expand and/or via an expansion mechanism such as a balloon) radially outward (e.g., relative to central longitudinal axis 111). In some examples, expandable structure 190 is configured to expand radially outward relative to central longitudinal axis 111 to a deployed configuration, such as to position electrodes 170 into apposition with a blood vessel wall (e.g., for delivering electrical stimulation therapy to tissue of patient 12 proximate the blood vessel and/or sensing a patient parameter from a location within the Docket No. A0012241W001 blood vessel). For example, expandable structure 190 can include one or more of a selfexpanding structure (e.g., frame), including one or more of a self-expanding stent, a selfexpanding coil, or another suitable expandable structure (e.g., that includes one or more struts and/or splines). In some examples, expandable structure 190 is at least partially self-expanding (e.g., expandable structure 190 can be partially self-expanding at least to a first maximum outer dimension, and subsequently expanded to second, larger maximum outer dimension via a balloon or another suitable expansion mechanism).

[0119] Expandable structure 190 can include suitable configurations for mechanically coupling to and/or carrying one or more electrodes of electrodes 170. In some examples, expandable structure 190 includes structural features configured to enable and/or facilitate mechanical coupling of electrodes 170 to expandable structure 190, as well as orient electrodes 170 with respect to expandable structure 190. In some examples, one or more of struts 192 are configured to mechanically couple to one or more electrodes 170. In addition to or instead of struts 192, in some examples, expandable structure 190 includes other structures (e.g., weld pads, projections, apertures, and/or other structural features) configured to receive, mechanically couple to, or otherwise carry one or more of electrodes 170.

[0120] In the example of FIG. 3 A and FIG. 3B, expandable structure 190 includes structural features configured to enable and/or facilitate mechanical coupling of electrodes 170 to expandable structure 190 as well as orient electrode 170 with respect to expandable structure 190. As shown in FIG. 3 A and FIG. 3B, expandable structure 190 (e.g., the frame of expandable structure 190 formed by struts 192) defines a plurality of apertures 193. In the example of FIG. 3 A, at least two of apertures 193 are not shown with a corresponding electrode of electrodes 170 for illustrative clarity, however each and/or any of electrodes 170A-170F can be mechanically coupled to expandable structure 190 via a respective one of apertures 193. Each aperture of apertures 193 is configured to enable and/or facilitate mechanical coupling of one or more of electrodes 170 to expandable structure 190, as well as orient one or more of electrodes 170 with respect to expandable structure 190. For example, in some examples, each of apertures 193 is configured receive a portion of one of electrodes 170 and/or another structure mechanically coupled to one of electrodes 170 such that an electrically conductive portion of each of electrodes 170 (e.g., an electrically conductive major surface of electrode 170) faces (e.g., points) radially outward from expandable structure 190 (e.g., away from central longitudinal axis 111). Docket No. A0012241W001

[0121] Each and/or any of electrodes 170 can define any suitable shape and have any suitable configuration. In some examples, one or more of electrodes 170 is configured to facilitate directional electrical stimulation and/or sensing (e.g., radially outward from expandable structure 190). For example, in some examples, one or more electrodes 170 define a major surface (e.g., a flat or substantially flat surface) that is electrically conductive and configured to face radially outward from expandable structure 190 (e.g., away from central longitudinal axis 111). In some examples, one or more electrodes 170 define a non-cylindrical shape (e.g., such that at an electrically conductive surface of one or more of electrodes 170 is flat or substantially flat). In some examples, using non- cylindrical electrodes 170 (e.g., that include an electrically conductive major surface that can only be mechanically coupled to expandable structure 190 in one or two orientations) can facilitate directionality of an electrically conductive surface (e.g., a major surface) of each of electrodes 170 radially outward from expandable structure 190. In some examples, only some portions of each of electrodes 170 are configured for transmitting and/or receiving electrical energy and/or signals. In some examples, using non-cylindrical electrodes can reduce or even eliminate a need for electrically insulative materials (e.g., an electrically insulative coatings) for facilitating directional electrical stimulation and/or sensing. In some examples, non-cylindrical electrodes do not include a surface treatment (e.g., etching, texturing, and/or the like) to increase the electrically conductive surface area.

[0122] In some examples, each of apertures 193 is configured to minimize rotation (e.g., reduce or even eliminate rotation) of a given electrode of electrodes 170 with respect to a respective strut of struts 192 (e.g., by fixing an orientation of a given one of electrodes 170 with respect to one or more of struts 192). For example, as discussed more fully herein, each of apertures 193 can be configured to prevent rotation of a respective one of electrodes 170 relative to expandable structure 190.

[0123] Expandable structure 190 includes any suitable number of apertures 193. As shown in the example of FIG. 3B, expandable structure 190 includes eight apertures 193. However, expandable structure 190 can include any suitable number of apertures 193 (e.g., one, two, three, four, five, six, seven, eight, nine, ten, twelve, fifteen, twenty, thirty, etc.). The number of apertures 193 may depend on the number of electrodes 170. In some examples, as illustrated in FIG. 3 A, expandable structure 190 includes more of apertures 193 than electrodes 170 that are eventually affixed to expandable structure 190, such that expandable structure 190 can be pre-fabricated, and a suitable number, configuration, and Docket No. A0012241W001 pattern of electrodes 170 can subsequently be mechanically coupled to expandable structure 190 (e.g., depending on the end use of endovascular therapy system 100, including the specific anatomical location where endovascular therapy system is used). In some examples, not all the apertures 193 of a given expandable structure 190 will be used to mechanically couple electrodes 170 to expandable structure 190, but some apertures 193 will not be used for mechanically electrodes 170 to expandable structure 190 after all of the desired number of electrodes 170 are coupled to expandable structure 190.

[0124] In some examples, expandable structure 190 includes apertures 193 at multiple circumferential positions around expandable structure 190 (e.g., around central longitudinal axis 111) and/or at multiple axial positions along expandable structure 190 (e.g., spaced apart along central longitudinal axis 111). Although referred to as circumferential positions, in some examples, expandable structure 190 is not circular in cross-section (the cross-section being taken in a direction orthogonal to central longitudinal axis 111). In such examples, the circumferential positions may still refer to the rotational position about central longitudinal axis 111). Longitudinal spacing and/or circumferential spacing between apertures 193 can correspond to desired longitudinal spacing and/or circumferential spacing between electrodes 170 for therapeutically effective endovascular stimulation and/or sensing once expandable structure 190 is in a deployed configuration.

[0125] As illustrated in at least FIG. 3A, FIG. 3C, and FIG. 3D, expandable structure 190 can also be configured to orient electrodes 170 to face radially outward from central longitudinal axis 111 (e.g., when expandable structure 190 is in the deployed configuration). In some examples, expandable structure 190 is configured to position electrodes 170 in apposition with a blood vessel wall (e.g., after endovascular therapy system 100 including expandable structure 190 is advanced proximate to a target location in the vasculature of a patient, such as patient 12 of FIG. 1, and transformed into the deployed configuration). For example, electrodes 170 may face radially outward at an orientation that is sufficient to deliver electrical energy to or sense electrical signals from target tissue (e.g., nerves and/or brain tissue surrounding a blood vessel). In some examples, expandable structure 190, as well as the structures configured to facilitate mechanical coupling of electrodes 170 to expandable structure 190 (e.g., apertures 193 and/or electrode attachment element 180 described further in connection with FIG. 3D) are configured to bias transmissions of electrical signals to and/or sensing of signals via electrodes 170 from tissue surrounding blood vessel as compared to radially inward from Docket No. A0012241W001 the blood vessel wall. In this way, endovascular therapy system 100 is configured to facilitate directional electrical stimulation therapy and/or directional sensing, such as in a direction radially outward from expandable structure 190 and/or a blood vessel and towards a blood vessel wall. Fixing electrodes 170 such that electrically conductive portions face radially outward towards a vessel wall and/or that electrically nonconductive portions or less conductive portions face radially inwards towards central longitudinal axis 111 may facilitate relatively more efficient (e.g., in terms of power used and/or power lost) electrical stimulation therapy and/or sensing, such as compared to other types of systems that do not fix or orient conductive surfaces of electrodes 170 in a particular direction.

[0126] Endovascular therapy system 100, including expandable structure 190, may be configured to have a relatively low-profile configuration to facilitate delivery and/or placement into relatively narrow and/or tortuous vessels. Once proximate a target location, expandable structure 190 can be configured to transform to the deployed configuration (e.g., to position the one or more of electrodes 170 to deliver electrical stimulation to tissue of patient 12 or sense a patient parameter from a location within the blood vessel). In some examples, when expandable structure 190 is in a deployed configuration, electrodes 170 are positioned radially outside of expandable structure 190. Such positioning of electrodes 170 radially outside of expandable structure 190 (e.g., to protrude from expandable structure 190) can help ensure electrodes 170 remain in apposition with a vessel wall of a blood vessel, which can facilitate greater efficiency in terms of electrical energy delivered to tissue surround the blood vessel (e.g., as compared to systems in which electrodes 170 are not positioned radially outside of expandable structure 190). In other examples, expandable structure 190 is configured to position electrodes 170 such that at least one surface of each of electrodes 170 is flush or nearly flush with the outer surface of expandable structure 190 (e.g., when expandable structure 190 is in the deployed configuration).

[0127] Endovascular therapy system 100 can include any suitable number of electrodes 170. While the example of FIG. 3 A and FIG. 3B illustrate endovascular therapy system as including six of electrodes 170, endovascular therapy system 100 can include any suitable number of electrodes 170 (e.g., one electrode, two electrodes, three electrodes, four electrodes, five electrodes, six electrodes, seven electrodes, eight electrodes, nine electrodes, ten electrodes, twelve electrodes, fifteen electrodes, sixteen electrodes, seventeen electrodes, eighteen electrodes, twenty electrodes, thirty electrodes, Docket No. A0012241W001 or more electrodes). Each of electrodes 170 can be disposed at respective spaced-apart locations along and/or around expandable structure 190 (e.g., corresponding to the axially and/or circumferential spacing of apertures 193).

[0128] Expandable structure 190 can include electrodes 170 at multiple circumferential positions around expandable structure 190 and/or multiple longitudinal positions along expandable structure 190 (e.g., spaced apart along central longitudinal axis 111). Longitudinal spacing and/or circumferential spacing between electrodes 170 can correspond to desired longitudinal spacing and/or circumferential spacing between electrode 170 for therapeutically effective endovascular stimulation and/or sensing.

[0129] In some examples, as illustrated in FIG. 3 A, electrodes 170A-170F collectively form an array of electrodes 170. At least some of electrodes 170 that form array of electrodes 170 can be spaced apart by suitable distances (e.g., axial distances in a direction along central longitudinal axis 111 of expandable structure 190 as well as circumferential distances in a direction around central longitudinal axis 111), such as to effectuate nerve stimulation and/or sensing from an endovascular location. In some examples, as shown in the example of FIG. 3 A, array of electrodes 170 includes at least six of electrodes 170A-170F.

[0130] In the expanded configuration of expandable structure 190, electrodes 170A- 170F of the array of electrodes 170 are each disposed at multiple axial locations along expandable structure 190 (e.g., along central longitudinal axis 111 of expandable structure 190) and disposed at multiple circumferential locations around expandable structure 190 (e.g., in a circumferential direction around central longitudinal axis 111). In some examples, at least some axially adjacent electrodes 170 are spaced apart by about 5.0 mm to about 7.0 mm (e.g., between respective axial centers of the respective axially adjacent electrodes 170), such as about 6.0 mm. For example, in the example of FIG. 3 A, electrode 170A and electrode 170B are axially adjacent electrodes, and can be spaced apart by about 5.0 mm to about 7.0 mm, such as about 6.0 mm (e.g., as measured in an axial and/or longitudinal direction along expandable structure 190, such as in a direction parallel to central longitudinal axis 111).

[0131] In some examples, at least some circumferentially adjacent electrodes 170 are spaced apart by about 5.0 mm to about 7.0 mm (e.g., between respective circumferential centers of the respective axially adjacent electrodes 170 with respect to expandable structure 190), such as about 6.0 mm. For example, electrode 170A and electrode 170D are circumferentially adjacent electrodes, and can be spaced apart by about 5.0 mm to Docket No. A0012241W001 about 7.0 mm, such as about 6.0 mm (e.g., as measured in a circumferential direction around expandable structure 190, such as in a circumferential path around central longitudinal axis 111). Such axial and circumferential spacing described herein can be sufficient as to effectively stimulate and/or sense a nerve surrounding a blood vessel (e.g., jugular vein 13), even though expandable structure 190 is disposed with the blood vessel. Such stimulation and/or sensing from an endovascular location may require relatively more energy and/or sensitivity of electrodes (e.g., as compared to instances of nerve stimulation and/or sensing from a non-endovascular location).

[0132] Electrodes 170 can be fabricated using any suitable method. In some examples, electrodes 170 are formed from a suitable machining (milling, turning, grinding, or electrical discharge machining) and/or stamping process. Electrodes 170 can be formed separately from, and subsequently mechanically coupled to, expandable structure 190. In such examples, electrodes 170 may be manufactured using relatively inexpensive or high precision techniques that do not require accommodating other structures, such as expandable structure 190.

[0133] In some examples, one or more elements of therapy system 100 are configured to facilitate positioning of electrodes 170 at the target site (e.g., via radiographic and/or radiopaque portions that indicate a positioning of electrodes 170). For example, therapy system 100 can include a radiographic or radiopaque marker to indicate an axial position and/or circumferential position of one or more of electrodes 170 along and/or around central longitudinal axis 111. In some examples, at least a portion of therapy system 100 is aligned with one or more of electrodes 170 (and/or circumferentially aligned an array of electrodes formed from a group of electrodes 170) to indicate a direction (e.g., a radial direction) faced by electrodes 170. In some examples, therapy system 100 (e.g., one or more components of therapy system 100) includes a radiographic marker that is circumferentially aligned with one or more of electrodes 170 and/or an array of electrodes 170. For example, one or more of medical lead 160 and/or expandable structure 190 (or sub-components thereof) includes a radiographic or radiopaque material circumferentially aligned with electrodes 170 and configured to indicate a radial direction (e.g., a radial direction outwards from central longitudinal axis 111) faced by electrodes 170 (e.g., while expandable structure 190 is undergoing transformation from the delivery configuration to the deployed configuration and/or when expandable structure 190 is in the deployed configuration). Docket No. A0012241W001

[0134] Although the examples of FIG. 3A and FIG. 3C are described with respect to electrodes 170 that are configured to deliver electrical stimulation therapy and/or sense electrical signals, endovascular therapy system 100 can additionally or alternatively include other types of therapy delivery elements and/or sensing elements, such as therapy delivery and/or sensing elements for which a directionality for delivery of therapy or sensing of signals may be particularly advantageous. In these examples, one or more of the other therapy delivery elements and/or sensing elements are configured to be attached to expandable structure 190 using a similar method of attachment as electrodes 170. As an example, in some examples, endovascular therapy system 100 includes one or more ultrasound transducers or chemical delivery elements (e.g., fluid delivery elements and/or drug elution elements) which can be configured to be attached to expandable structure 190 using a similar method of attachment as electrodes 170. In some examples, endovascular therapy system 100 additionally or alternatively includes one or more temperature sensors, pressure sensors, optical sensors, impedance sensors, chemical sensors, and/or other suitable types of sensing elements, which can be configured to be attached to expandable structure 190 using a similar method of attachment as electrodes 170.

[0135] FIG. 31, FIG. 3 J, and FIG. 3K illustrate a perspective view, a section view, and a side view of an example electrode fixation element 180. The cross-sectional view of FIG. 3 J illustrates a cross section of electrode fixation element 180 taken through a plane parallel to the x-axis and y-axis of FIG. 31 and intersecting a radial center of electrode fixation element 180. The side (e.g., top) view of FIG. 3K is a view parallel to the x-axis and z-axis of the orthogonal x-y-z axes of FIG. 31. In some examples, as illustrated in FIG. 3D, as well as FIG. 31, FIG. 3 J, and FIG. 3K, electrode fixation element 180 includes a fixation element body portion 182 and a fixation element flange portion 184. In some examples, fixation element body portion 182 defines a central longitudinal axis 185 (central longitudinal axis 185 is shown parallel to the y-axis direction according to the orthogonal x-y-z axes in FIG. 31 and FIG. 3J). In some examples, fixation element flange portion 184 extends radially outward from fixation element body portion 182 (e.g., radially outward relative to central longitudinal axis 185).

[0136] In some examples, as shown in FIG. 3D, fixation element body portion 182 is configured to be received by one of apertures 193 defined by expandable structure 190 and mechanically coupled to (e.g., directly mechanically coupled to) electrode 170A. In some examples, fixation element flange portion 184 is configured to remain radially Docket No. A0012241W001 inward of expandable structure 190, such as to anchor electrode 170 A to expandable structure 190. In this way, electrode fixation element 180 is configured to mechanically couple electrode 170A to expandable structure 190. In some examples, as illustrated in FIG. 3 J, fixation element body portion 182 defines a first maximum outer dimension D3 (e.g., which may be a diameter in the case of a circular cross-section) and fixation element flange portion 184 defines a second maximum outer dimension D4 (e.g., which may be a diameter in the case of a circular cross-section), wherein second maximum outer dimension D4 is greater than first maximum outer dimension D3. In some examples, first maximum outer dimension D3 is less than an inner maximum dimension of one of apertures 193 (e.g., such that fixation element body portion 182 can be received by one of apertures 193). In some examples, second maximum outer dimension D4 is greater than the inner maximum dimension of one of apertures 193 (e.g., such that fixation element flange portion 184 cannot pass through one of apertures 193).

[0137] In some examples, electrode fixation element 180 is configured to mechanically couple to (e.g., directly mechanically couple to) a portion of electrode 170A via a suitable mechanical connection (e.g., welded, crimped, interference fit, and/or the like). In some examples, as illustrated in FIG. 3D, electrode fixation element 180 is sized, shaped, and/or otherwise configured to be received in a portion of electrode 170A. In some examples, hole 173 of electrode 170A (illustrated in FIG. 3G and FIG. 3H) and electrode fixation element 180 include corresponding mating features (e.g., edges), which can be configured to align and/or orient electrode 170A relative to electrode fixation element 180. Thus, hole 173 of electrode 170A and electrode fixation element 180 can cause electrode 170A to be oriented in a particular manner relative to expandable structure 190 (e.g., because aperture 193 of expandable structure 190 and electrode fixation element 180 also include respective mating features to orient and/or align electrode fixation element 180 relative to expandable structure 190). In some examples, due to the configuration of electrode 170A, electrode fixation element 180, and aperture 193 of expandable structure 190, electrode 170A can only be mechanically connected to expandable structure 190 in one or two orientations.

[0138] In some examples, electrode fixation element 180 is sized, shaped, and/or otherwise configured to be received within aperture 193. In some examples, as noted above, aperture 193 of expandable structure 190 and electrode fixation element 180 include respective mating features to orient and/or align electrode fixation element 180 relative to expandable structure 190. Thus, when electrode fixation element 180 is Docket No. A0012241W001 received by aperture 193 and mechanically coupled to electrode 170A, aperture 193 is configured to limit movement (e.g., rotation) of electrode 170A relative to expandable structure 190. For example, electrode fixation element 180 and aperture 193 can be configured to limit rotation of electrode 170A relative to axis 171 (e.g., a radial axis extending through a center of electrode 170 A and orthogonal to at least one radially outward face of electrode 170A). Preventing movement (e.g., of rotation) of electrodes 170 relative to expandable structure 190 can ensure that physical interference (e.g., touching) between adjacent electrodes 170 disposed on the expandable structure 190 is limited or entirely avoided, which can otherwise limit the ability of the expandable structure 190 from fully transforming to the delivery (e.g., radially compressed) configuration. Further, preventing contact between adjacent electrodes 170 can limit or prevent electrical shorting via unwanted physical contact between two or more electrodes 170 disposed on expandable structure 190.

[0139] In some examples, as illustrated in at least FIG. 3K, electrode fixation element 180 defines a cross-sectional profile configured to mate with apertures 193. For example, when at least body portion 182 of electrode fixation element 180 is received by aperture 193 of expandable structure 190, aperture 193 is configured to limit or prevent rotation of electrode fixation element 180 relative to expandable structure 190. As illustrated in at least FIG. 3K, body portion 182 of electrode fixation element 180 can define a similar size, shape, and/or profile of aperture 193 (e.g., including two straight edges and two curved edges, or other noncircular shapes), such that when electrode fixation element 180 is received by aperture 193, aperture 193 limits or prevents movement (e.g., rotation) of electrode fixation element 180 (e.g., about central longitudinal axis 185 of fixation element body portion 182).

[0140] In some examples, when a portion of electrode fixation element 180 (e.g., body portion 182) is positioned in aperture 193 of expandable structure 190 and mechanically coupled to electrode 170 A, fixation element flange portion 184 is configured to anchor electrode 170A to the expandable structure 190. For example, in some examples, second maximum outer dimension D4 of fixation element flange portion 184 is larger than a maximum inner dimension of aperture 193 such that fixation element flange portion 184 is unable to pass through aperture 193, thus anchoring electrode 170A to expandable structure 190.

[0141] In some examples, electrode fixation element 180 is configured to receive crimp structure 168. By receiving crimp structure 168, electrode fixation element 180 can Docket No. A0012241W001 enable and/or facilitate electrical coupling and/or mechanically coupling between conductor wire 166A and electrode 170A. In some examples, as illustrated in FIG. 31, FIG. 3 J, and FIG. 3K, electrode fixation element 180 defines an electrode fixation element lumen 183. In some examples, electrode fixation element lumen 183 is be sized, shaped, and/or otherwise configured to receive crimp structure 168.

[0142] In some examples, crimp structure 168 is configured to mechanically couple a portion of conductor wire 166A to electrode 170A (e.g., either directly or indirectly). For example, as shown in FIG. 3D, crimp structure 168 can be mechanically coupled to conductor wire 166 A. In some examples, as illustrated in FIG. 3D, when crimp structure 168 is positioned within a lumen defined by electrode fixation element 180 (e.g., electrode fixation element lumen 183), electrode fixation element 180 can be mechanically coupled to electrode 170 A, thus indirectly mechanically coupling conductor wire 166A to electrode 170A. Such mechanical connection can also electrically connect conductor wire 166A to electrode 170A, as crimp structure 168 and electrode attachment element 180 can include electrically conductive materials. In some examples, after crimp structure 168 and conductor wire 166 A are positioned within electrode fixation element 180, a fill material 165 (e.g., an adhesive) is filled within a portion of electrode fixation element 180, such as to further secure crimp structure 168 and/or conductor wire 166A relative to electrode fixation element 180.

[0143] In other examples, crimp structure 168 is configured to be directly mechanically coupled to electrode 170A (e.g., without electrode fixation element 180 between crimp structure 168 and electrode 170A). For example, in some examples, a portion of electrode 170A (e.g., hole 173 of electrode 170A shown in FIG. 3G and FIG. 3H) is configured to receive and/or directly mechanically couple to crimp structure 168. [0144] In some examples, crimp structure 168 is sized, shaped, and/or otherwise configured to pass through aperture 193 of expandable structure 190. For example, as illustrated in FIG. 3D, crimp structure 168 defines a smaller maximum dimension (e.g., in the positive and negative x-axis direction according to the orthogonal x-y-z axes of FIG. 3D) as compared to aperture 193. In this way, conductor wire 166A and crimp structure 168 can be routed proximate to a radially inward surface of electrode 170A (e.g., and avoid needing to be connected to a radially outward surface of electrode 170A).

[0145] In some examples, when electrode 170 A is mechanically coupled to the expandable structure 190 via aperture 193 (e.g., as illustrated in FIG. 3D), aperture 193 is configured to limit rotation of electrode 170A relative to expandable structure 190. For Docket No. A0012241W001 example, in some examples, electrode 170A and/or expandable structure 190 define a radial axis 171 (e.g., in which radial 171 extends radially outward from and orthogonal to central longitudinal axis 111 as illustrated in FIG. 3 A and FIG. 3B), and aperture 193 is configured to limit or prevent rotation of electrode 170A about (e.g., around) radial axis 171. In some examples, radial axis 171 is orthogonal to a face of electrode 170A (e.g., a face of electrode 170 facing radially outward relative to central longitudinal axis 111 of expandable structure 190). In this way, each of apertures 193 can maintain electrode 170 in an orientation such that first maximum dimension DI of electrode 170 (e.g., as illustrated in FIG. 3H) extends along central longitudinal axis 111 of expandable structure 190. Such orientation of at least some of electrodes 170 can limit or prevent the electrodes 170 from physically interfering with each other (e.g., touching), even when the expandable structure 190 is transformed into the delivery configuration (e.g., a radially compressed configuration). The use of oblong electrodes 170 and the orientation of such oblong electrodes 170 with respect to expandable structure 190 can enable the use of a relatively greater number of electrodes 170 and/or enable each electrode 170 to have a relatively greater conductive surface area (e.g., as compared to electrodes having other shapes, such as circles).

[0146] In some examples, an electrically insulative material (e.g., an electrically insulative coating and/or electrically insulative structure) is positioned between one or more of electrodes 170 and expandable structure 190 (e.g., the frame of expandable structure 190 that includes struts 192). In some examples, the electrically insulative material is configured to electrically insulate electrodes 170 from the expandable structure 190. For example, a radially inward surface of one of electrodes 170 and/or a radially outward surface of expandable structure can include an electrically insulative coating.

[0147] In some examples, as illustrated in FIG. 3D, an electrically insulative structure 175 is positioned such that at least a portion of electrically insulative structure 175 is positioned between electrode 170 and strut 192 of expandable structure 190. Electrically insulative structure 175 can include a suitable electrically insulative material, including a polymer (e.g., silicone). Electrically insulative structure 175 can be configured to electrically insulate electrode 170A from the expandable structure 190. Electrically insulative structure 175 can also serve to prevent electrode 170A from physically contacting expandable structure 190 (e.g., because at least a portion of electrically insulative structure 175 is positioned between adjacent surfaces of electrode 170 and Docket No. A0012241W001 expandable structure 190). Limiting and/or preventing physical contact between electrode 170A and the body of the expandable structure can limit or prevent unwanted electrical communication between electrode 170A and expandable structure 190 (e.g., such that electrode 170A and the expandable structure 190 structure remain electrically isolated). [0148] In some examples, electrically insulative structure 175 reduces or eliminates a need for electrically insulative coatings applied to either of electrode 170A and/or expandable structure 190, which may facilitate an easier and/or repeatable assembly process. Additionally and/or alternatively, use of electrically insulative structure 175 that includes a polymer (e.g., silicone) may be relatively longer lasting as compared to electrically insulative coatings, such that electrode 170 and expandable structure 190 can remain electrically isolated over relatively long durations of time, which may be useful in applications of chronic therapy delivery when expandable structure 190 and electrodes 170 are implanted within a blood vessel of patient.

[0149] FIG. 3L illustrates a cross-sectional view of insulative structure 175. The cross-sectional view of FIG. 3L illustrates a cross section of insulative structure 175 taken through a plane parallel to the x-axis and y-axis of FIG. 3L and intersecting a radial center of electrode insulative structure 175. Electrically insulative structure 175 can define any suitable shape. For example, in some examples, as illustrated in FIG. 3D and FIG. 3L, electrically insulative structure 175 includes at least a first flange portion 176A, a second flange portion 176B, and a body portion 177 between first flange portion 176A and second flange portion 176B (e.g., such that body portion 177 connects first flange portion 176A and second flange portion 176B). As illustrated in FIG. 3D and FIG. 3L, first flange portion 176A and second flange portion 176B extend radially outward from body portion 177. In some examples, insulative structure 175 is symmetric (e.g., radially symmetric) about a central longitudinal axis 178 of insulative structure 175.

[0150] As illustrated in the example of FIG. 3D and FIG. 3L, each of first flange portion 176A and second flange portion 176B define a maximum dimension D5 (e.g., which may be a diameter in the case of a circular or near circular cross-section of first flange portion 176A and/or second flange portion 176B). In some examples, maximum dimension D5 is larger than an inner maximum cross-sectional dimension of aperture 193 (e.g., such as to prevent either of first flange portion 176A and/or second flange portion 176B from easily falling through aperture 193). However, electrically insulative structure 175 can include a relatively flexible material, such that electrically insulative structure 175 can be folded, rolled, and/or otherwise deformed to initially place electrically Docket No. A0012241W001 insulative structure 175 through and within aperture 193 (e.g., such that body portion 177 is seated within aperture 193).

[0151] In some examples, as illustrated in FIG. 3L, electrically insulative structure 175 defines a lumen 179. Lumen 179 can be sized, shaped, and/or otherwise configured to receive one or more of crimp structure 168 and/or electrode fixation element 180 (e.g., at least fixation element body portion 182). In some examples, lumen 179 defines a maximum cross-sectional inner dimension D6 (e.g., which may be a diameter in the case of a circular or near circular cross-section of lumen 179). In some examples, maximum cross-sectional inner dimension D6 is greater than an outer cross-sectional dimension of one or more of crimp structure 168 and/or electrode fixation element 180.

[0152] In some examples, at least body portion 177 of electrically insulative structure 175 is sized, shaped, and/or otherwise configured to be received by and/or positioned in one of apertures 193 of expandable structure 190. For example, as illustrated in FIG. 3D, electrically insulative structure 175 can be sized, shaped, and/or otherwise configured such that body portion 177 is positioned within aperture 193 (e.g., and with first flange portion 176A proximate to and extending along first face 194A of expandable structure 190 and second flange portion 176B proximate to and extending along second face 194B of expandable structure 190. As illustrated in FIG. 3L, body portion 177 can define an outer cross-sectional dimension D7, which may be smaller than or equal to an inner maximum cross-sectional dimension of aperture 193. In some examples, when insulative structure 175 is received by and positioned in aperture 193, first flange portion 176A abuts at least a portion of first face 194 A of expandable structure 190 and the second flange portion 176B abuts at least a portion of the second face of second face 194B of expandable structure 190 (e.g., wherein expandable structure 190 can include an expandable frame).

[0153] While the example of FIG. 3D and FIG. 3L illustrates electrically insulative structure 175 as having both first flange portion 176A and second flange portion 176B, in other examples, electrically insulative structure 175 only includes one of first flange portion 176A or second flange portion 176B (e.g., with or without body portion 177). For example, in some examples, electrically insulative structure 175 defines a disk shape (similar to one of first flange portion 176A or second flange portion 176B without body portion 177). For example, an electrically insulative disk can be positioned between a radially inward surface of electrode 170A and a radially outward surface of expandable structure 190, such as second face 194B of expandable structure 190 shown in FIG. 3B. Docket No. A0012241W001

As another example, an electrically insulative disk can be positioned between a radially inward surface of expandable structure 190, such as first face 194 A, and at least one surface of electrode attachment element 180 (e.g., flange portion 184 of electrode attachment element 180).

[0154] In some examples, electrodes 170 are configured to resist catching and/or snagging on a portion of a delivery catheter when expandable structure 190 is moved relative to (e.g., advanced distally relative to and/or proximally retracted relative to) the delivery catheter. For example, as illustrated in FIG. 3D, electrode 170A can define a beveled edge 174. For example, beveled edge 174 can be a generally rounded outer edge of electrode 170A and/or a tapered outer edge of electrode 170A. In some examples, as shown in the example of FIG. 3D, beveled edge 174 slopes toward axis 171 in a direction radially outward relative to expandable structure 190 (e.g., in the positive y-axis direction according to the orthogonal x-y-z axes of FIG. 3D). Beveled edge 174 of electrode 170 can reduce or eliminate the possibility of a distal end of a delivery catheter catching and/or snagging on electrode 170 when expandable structure 190 is moved relative to (e.g., advanced distally relative to and/or proximally retracted relative to) the delivery catheter. Additionally and/or alternatively, beveled edge 174 of electrode 170 can generally increase the conductive surface area of electrode 170 facing radially outward from expandable structure 190 (e.g., radially outward from central longitudinal axis 111 of FIG. 3 A), which can enable relative more efficient energy delivery and/or sensing (e.g., as compared to examples in which electrode 170 does not define beveled edge 174). [0155] FIG. 3E and FIG. 3F illustrate a section view and a side (e.g., top) view, respectively of a portion of expandable structure 190 that defines an aperture 193. Aperture 193 can define any suitable shape. For example, as shown in the example of FIG. 3F, aperture 193 defines a non-circular shape. In some examples, aperture 193 includes at least one straight edge 196 and at least one curved edge 197. In some examples, the non-circular shape of aperture 193 and/or the use of at least one straight edge 196 and at least one curved edge 197 can enable aperture 193 to prevent rotation of electrode 170A. For example, straight edge 196 and curved edge 197 can be configured to mate with one or more corresponding features of another component (e.g., corresponding features of an electrode fixation element 180, as shown in and described with respect to FIG. 31, FIG. 3 J, and FIG. 3K), such as to prevent rotation of electrode 170 attached to expandable structure 190 about (e.g., around) radial axis 171 illustrated in FIG. 3D. In some examples, straight edge 196 and curved edge 197 enable aperture 193 to orient one Docket No. A0012241W001 of electrodes 170 in a particular direction with respective to strut 192 and/or expandable structure 190 more generally. For example, straight edge 196 and curved edge 197 can be configured to mate with a corresponding feature of another component (e.g., corresponding features of an electrode fixation element 180, as shown in and described with respect to FIG. 31, FIG. 3 J, and FIG. 3K), such as to orient a larger dimension of electrode 170 (e.g., that first maximum dimension DI of electrode 170, as illustrated in FIG. 3H) along (e.g., substantially parallel to parallel to) central longitudinal axis 111 of expandable structure 190.

[0156] FIG. 3G and FIG. 3H illustrate a perspective view and a side (e.g., top) view, respectively, of an example electrode 170A, which is an example of any of electrodes 170A-170F of FIG. 3 A, FIG. 3C, and/or FIG. 3D, or any of electrodes 17 of FIG. 1. As shown in the example of FIG. 3H, electrode 170A defines a first maximum dimension DI in a first direction (e.g., in the positive and negative x-axis direction according to the orthogonal x-y-z axes of FIG. 3H, which may be along a major axis of electrode 170A). The x-axis direction of FIG. 3H can correspond to a direction along (e.g., parallel to) central longitudinal axis 111 of the expandable structure 190 as shown in the examples of FIG. 3 A and FIG. 3B when electrode 170A is mechanically connected to expandable structure 190. As shown in the example of FIG. 3H, electrode 170A defines a second maximum dimension D2 in a second direction (e.g., in the positive and negative z-axis direction according to the orthogonal x-y-z axes of FIG. 3H, which may be along a minor axis of electrode 170A) transverse to the first direction. In some examples, the second direction (e.g., the direction in which electrode 170A defines second maximum dimension D2) is orthogonal to the first direction (e.g., the direction in which electrode 170A defines first maximum dimension DI).

[0157] In some examples, first maximum dimension DI is greater than second maximum dimension D2 (e.g., first maximum dimension DI is at least double second maximum dimension D2). Because of this shape and/or orientation of electrode 170A when mechanically coupled to expandable structure 190, electrode 170A can be considered an oblong electrode 170A. In such examples, the first direction can also be referred to as a major axis and the second direction can also be referred to as a minor axis. [0158] In some examples, as illustrated in FIG. 3G and FIG. 3H, electrode 170A defines a hole 173. In some examples, as illustrated in FIG. 3D, hole 173 is configured to receive conductor wire 166A (and/or crimp structure 168 connected to conductor wires 166A, as illustrated in the example of FIG. 3D). By receiving conductor wire 166A Docket No. A0012241W001

(and/or crimp structure 168 connected to conductor wires 166A), electrode 170 can be electrically coupled to conductor wire 166 A, which may be electrically coupled to a medical device (e.g., medical device 14 of FIG. 1). Hole 173 can extend partially or entirely though each of electrodes 170.

[0159] In some examples, hole 173 is shaped, sized, and/or otherwise configured to prevent rotation of electrode 170A relative to expandable structure 190. For example, hole 173 can define a shape having mating features corresponding to crimp 168 and/or electrode fixation element 180, such to as a fix an orientation of electrode 170 relative to expandable structure 190 when electrode 170A is mechanically coupled to expandable structure 190. In some examples, hole 173 is configured to receive at least a portion of electrode fixation element 180.

[0160] FIG. 3M and FIG. 3N illustrate a perspective view and a cross-sectional view respectively of an example crimp structure 168. The cross-sectional view FIG. 3N illustrates a cross section of crimp structure 168 taken through a plane parallel to the x- axis and y-axis of FIG. 3M and intersecting a radial center of crimp structure 168. In some examples, crimp structure 168 defines a cylinder shape. In some examples, crimp structure 168 defines a lumen 169. Lumen 169 of crimp structure 168 can be configured to receive a respective one of conductor wires 166.

[0161] FIG. 4A and FIG. 4B illustrate side views of an example expandable structure 490, which is an example of expandable structure 19 of FIG. 1, or expandable structure 190 of FIG. 3 A, FIG. 3B, FIG. 3C, and/or FIG. 3D, and/or any of the other expandable structures described in this disclosure. For example, expandable structure 490 includes a plurality of struts 492, which may be configured similarly as struts 192 of at least FIG.

3 A, FIG. 3B, and FIG. 3D, except as described herein. In the example of FIG. 4A and FIG. 4B, expandable structure 490 extends from an expandable structure proximal end 490A to an expandable structure distal end 490B and defines a central longitudinal axis 411 (e.g., such that central longitudinal axis 411 extends through a radial center of expandable structure 490). In the example of FIG. 4A and FIG. 4B, a plurality of electrodes 470 are mechanically coupled to expandable structure 490 at respective axially and circumferentially spaced apart locations relative to expandable structure 490. Each of electrodes 470 may be examples of electrodes 17 of FIG. 1 or electrodes 170 of at least FIG. 3 A, FIG. 3C, and/or FIG. 3D.

[0162] FIG. 4A illustrates expandable structure 490 in a delivery (e.g., relatively low- profile, such as compressed, including radially compressed relative to central longitudinal Docket No. A0012241W001 axis 411) configuration, and FIG. 4B illustrates expandable structure 490 in a deployed (e.g., expanded, such as radially expanded relative to central longitudinal axis 411) configuration. In some examples, as illustrated in FIG. 4A, when expandable structure 490 is in the delivery (e.g., relatively low-profile and/or compressed) configuration, expandable structure 490 defines a first maximum outer dimension D8 (e.g., which may be a diameter in the case of a circular cross-section of expandable structure 490). In some examples, first maximum outer dimension D8 is sufficiently small such as to enable expandable structure 490 to be introduced into one or more of an introducer sheath, a delivery catheter, or another delivery member.

[0163] As shown in the example of FIG. 4 A, electrodes 470 are sized, shaped, and positioned relative to expandable structure 490 such that electrodes 470 do not physically interfere (e.g., touch) with each other, such that would otherwise inhibit expandable structure 490 to fully compress down to the delivery configuration of expandable structure 490 illustrated in FIG. 4A. The position and/or orientation of structural features used for mechanically coupling electrodes 470 to expandable structure 490 (e.g., apertures 193, as discussed in relation to at least FIG. 3A, FIG. 3B, and FIG. 3D) can enable the use of electrodes 470 with relatively large conductive surface areas while simultaneously limiting or preventing physical interference (e.g., contact) between adjacent electrodes 470, even in the delivery (e.g., compressed) configuration of expandable structure 490.

[0164] In some examples, when expandable structure 490 is in the deployed (e.g., expanded) configuration, as illustrated in FIG. 4B, expandable structure 490 defines a second maximum outer dimension D9 (e.g., which may be a diameter in the case of a circular cross-section of expandable structure 490), such that a second maximum outer dimension D9 is greater than first maximum outer dimension D8. In the deployed configuration of expandable structure 490, second maximum outer dimension D9 can be sufficiently large such that expandable structure 490 and/or electrodes 470 are brought into apposition with (e.g., into contact with such as to press into) a wall of a blood vessel (e.g., jugular vein 13 of patient 12 of FIG. 1). The respective axial and circumferential spacing between electrodes 470 when expandable structure 490 is in deployed (e.g., expanded) configuration can effectuate therapeutically effective electrical stimulation therapy and/or sensing even though expandable structure 490 and electrodes 470 are positioned endovascularly. Docket No. A0012241W001

[0165] Electrodes 470 can collectively form any suitable shape and/or pattern of individual electrodes position at respective axial and circumferential locations. The example of FIG. 4A and FIG. 4B illustrates electrodes 470 forming a three by two by three configuration, referring to three of electrodes 470 at a first axial location along central longitudinal axis 411, two of electrodes 470 at a second axial location along central longitudinal axis 411, and three of axial electrodes 470 at a third axial location along central longitudinal axis 411. However, other arrangements of electrodes 470 are contemplated (e.g., four by two, one by three by three by one, and/or the like). Further, while eight total electrodes 470 are shown in the example of FIG. 4A and FIG. 4B (e.g., that can be individually activated and/or controlled), other suitable numbers of electrodes 470 are contemplated (e.g., two, four, six, eight, ten, twelve, sixteen, thirty -two, or more electrodes 470).

[0166] FIG. 5 A and FIG. 5B illustrate a perspective view and a cross-sectional view, respectively, of another example crimp structure 568. The cross-sectional view FIG. 5B illustrates a cross section of crimp structure 568 taken through a plane parallel to the x- axis and y-axis of FIG. 5A and intersecting a radial center of crimp structure 568. Crimp structure 568 may be configured similarly to crimp structure 168 of FIG. 3D, FIG. 3M, and FIG. 3N, except as described herein. For example, crimp structure 568 can define a lumen 569 configured to receive one of conductor wires 166.

[0167] As illustrated in FIG. 5A and FIG. 5B, crimp structure 568 defines a tapered profile. For example, an outer surface of crimp structure 568 can taper between a first face 567A and a second face 567B of crimp structure 568. The tapered profile of crimp structure 568 can help crimp to remain positioned within and/or mechanically coupled to electrode fixation element 180 (e.g., by creating a wedge-like fit).

[0168] FIG. 6 illustrates a cross-sectional detail view of an example assembly including an electrode 670 and a portion of an expandable structure 690 including at least a strut 692. Electrode 670 is mechanically coupled to (e.g., fixedly connected to) expandable structure 690 via an electrode attachment element 680 extending through an aperture 693 of expandable structure 690. A crimp structure 668 electrically connects a conductor wire 666 to electrode 670. An electrically insulative structure 675 is positioned between at least a portion of electrode 670 and expandable structure 690 (e.g., to electrically insulate electrode 670 from expandable structure 690). The example assembly of FIG. 6 can be an example of the portion of endovascular therapy system 100 enclosed by dashed lines labeled as “A” in FIG. 3C. The example of FIG. 6 illustrates one manner Docket No. A0012241W001 in which electrode 670 can be mechanically coupled to expandable structure 690. Each of electrode 670, expandable structure 690, strut 692, electrode attachment element 680, and aperture 693, crimp structure 668, conductor wire 666, and electrically insulative structure 675 can be configured similar to electrode 170A, expandable structure 190, strut 192, electrode attachment element 180, aperture 193, crimp structure 168, conductor wire 166, and electrically insulative structure 175 as shown and described in connection with at least FIG. 3D, except as discussed herein. For example, in the example of FIG. 6, electrode 670 does not define a hole.

[0169] In examples in which electrode 670 does not define a hole, as illustrated in FIG. 6, crimp structure 668 and/or conductor wire 666 can be abutted against electrode 670 and fixedly attached using any suitable method (e.g., via adhesive, welding, or the like). In some examples, after crimp structure 668 and conductor wire 666 are positioned within electrode fixation element 680, a fill material 665 (e.g., an adhesive) is filled within a portion of electrode fixation element 680, such as to secure crimp structure 668 and/or conductor wire 666 relative to electrode fixation element 680.

[0170] As discussed herein, FIG. 6 generally illustrates an assembly of various components configured to enable and/or facilitate mechanical coupling of electrode 670 to expandable structure 690. The example of FIG. 6 also illustrates other components configured to electrically insulate electrode 670A from expandable structure 690. While each of the components described in FIG. 6 are described as separate (e.g., physically separate) components, it is understood that one or more of such components, in other examples, can be integral components.

[0171] FIG. 7 is a flow diagram illustrating an example technique for using a medical device system according to the techniques of this disclosure, which may include placing a medical lead in vasculature of a patient. The technique of FIG. 7 is described with respect to therapy system 10 of FIG. 1, as well as endovascular therapy system 100 of at least FIG. 3A (which is an example of therapy system 10 of FIG. 1), but may be used with any of the device, systems, and/or elements of systems described in this disclosure.

[0172] In the example of FIG. 7, the technique includes introducing an endovascular device (e.g., endovascular device 16 and/or medical lead 160) into vasculature of patient 12 (700). For example, a clinician may introduce at least distal portion 150 medical lead 160 through an access point in patient 12 (e.g., a femoral artery access point or radial artery access point). In some examples, one or more of an introducer sheath, a guide Docket No. A0012241W001 catheter, and/or a guidewire is used to facilitate introduction of medical lead 160 into patient 12.

[0173] In the example of FIG. 7, the technique further includes advancing medical lead 160 through the vasculature of the patient until electrodes 170 are adjacent a target location in the vasculature of patient 12 (702). In some examples, a clinician advances medical lead 160 through vasculature of patient 12 until electrodes 170 are located within jugular vein 13 and positioned adjacent vagus nerve 21. In other examples, a clinician advances medical lead 160 through vasculature of patient 12 until electrodes 170 are located within a cranial blood vessel proximate one or more target brain structures. In some examples, medical lead 160 including electrodes 170 is advanced to the target location with the aid of a delivery catheter.

[0174] Once electrodes 170 are adjacent the target location (e.g., vagus nerve 21, other nerve, or one or more brain structures), expandable structure 190 can be caused to transform to the deployed configuration (e.g., by advancing expandable structure 190 distally of a delivery catheter configured to restrain expandable structure 190 in the delivery configuration), which can cause electrodes 170 to be brought into apposition with a vessel wall of the blood vessel. In some examples, expandable structure 190, which can be at a distal portion of medical lead 160, is configured to transform from a relatively low-profile delivery configuration to a deployed configuration in a blood vessel of a patient (e.g., within jugular vein 13 of patient 12), at least in part, via self-expansion. In some examples, expandable structure 190 remains in the delivery configuration during advancement of medical lead 160 through the vasculature. In some examples, a clinician causes expandable structure 190 to transform to the deployed (e.g., expanded) configuration once electrodes 170 are adjacent the target site (e.g., by advancing expandable structure 190 distally of a delivery catheter).

[0175] In the deployed configuration of expandable structure 190, one or more of electrodes 170 can be positioned into apposition with the vessel wall (e.g., the vessel wall of jugular vein 13). In the deployed configuration of expandable structure 190, expandable structure 190 can be configured to position one or more of electrodes 170 to deliver electrical stimulation to tissue of patient 12 or sense a patient parameter from a location within a blood vessel (e.g., jugular vein 13 and/or a blood vessel within brain 18 of patient 12). Docket No. A0012241W001

[0176] Once positioned at or proximate to the target location, the clinician initiates (e.g., via programmer 20, or another suitable device) electrical stimulation therapy and/or sensing of one or more patient parameters by medical device 14 via electrodes 170.

[0177] In some examples, one or more elements of therapy system 100 are configured to orient electrodes 170 relative to expandable structure 190 and/or relative to the blood vessel of patient. For example, as discussed throughout this disclosure, electrodes 170 can be mechanically coupled to expandable structure 190 such that an electrically conductive surface of each of electrodes 170 faces radially outward from expandable structure 190 (e.g., radially outward from central longitudinal axis 111 of expandable structure 190) and/or that electrically nonconductive portions or less conductive portions of each of electrodes 170 face radially inwards towards central longitudinal axis 111 of expandable structure 190.

[0178] In some examples, the struts 192 of expandable structure 190 include and/or define structural features that help to align and/or orient electrodes 170 relative to expandable structure 190. For example, apertures 193 in struts 192 of expandable structure 190 can be configured to position and align oblong electrodes 170 such that a greater dimension of electrodes 170 extends along (e.g., parallel to) central longitudinal axis 111 of expandable structure 190. Such orientation of electrodes 170 can enable electrodes 170 to have a relatively high conductive surface area with little or no risk physical interference of adjacent ones of electrodes 170 (e.g., even in the delivery configuration of expandable structure 190 in which electrodes 170 may be brought into relatively close proximity with each other).

[0179] The techniques described in this disclosure, including those attributed to medical device 14, programmer 20, or various constituent components, may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as clinician or patient programmers, medical devices, or other devices. Processing circuitry, control circuitry, and sensing circuitry, as well as other processors and controllers described herein, may be implemented at least in part as, or include, one or more executable applications, application modules, libraries, classes, methods, objects, routines, subroutines, firmware, and/or embedded code, for example. In addition, analog circuits, components, and circuit Docket No. A0012241W001 elements may be employed to construct one, some or all of the processing circuitry 30, instead of or in addition to the partially or wholly digital hardware and/or software described herein. Accordingly, analog or digital hardware may be employed, or a combination of the two.

[0180] In one or more examples, the functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on, as one or more instructions or code, a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may be an article of manufacture including a non- transitory computer-readable storage medium encoded with instructions. Instructions embedded or encoded in an article of manufacture including a non-transitory computer- readable storage medium encoded, may cause one or more programmable processors, or other processors, to implement one or more of the techniques described herein, such as when instructions included or encoded in the non-transitory computer-readable storage medium are executed by the one or more processors. Example non-transitory computer- readable storage media may include RAM, ROM, programmable ROM (PROM), erasable programmable ROM (EPROM), electronically erasable programmable ROM (EEPROM), flash memory, a hard disk, a compact disc ROM (CD-ROM), a floppy disk, a cassette, magnetic media, optical media, or any other computer readable storage devices or tangible computer readable media.

[0181] In some examples, a computer-readable storage medium comprises non- transitory medium. The term “non-transitory” may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium stores data that can, over time, change (e.g., in RAM or cache).

[0182] The functionality described herein may be provided within dedicated hardware and/or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0183] This disclosure includes the following non-limiting examples. Docket No. A0012241W001

[0184] Example 1 : An endovascular medical device system includes an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure including an expandable frame defining one or more apertures, wherein the expandable structure defines a central longitudinal axis; and one or more electrodes, each electrode of the one or more electrodes mechanically coupled to the expandable structure via a respective aperture of the one or more apertures, wherein each electrode of the one or more electrodes defines a first maximum dimension in a first direction along the central longitudinal axis of the expandable structure and a second maximum dimension in a second direction transverse to the first direction, wherein the first maximum dimension is greater than the second maximum dimension, and wherein when each electrode of the one or more electrodes is mechanically coupled to the expandable structure via the respective aperture, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

[0185] Example 2: The endovascular medical device system of example 1, wherein the expandable structure is configured to expand radially outwards from a relatively low- profile delivery configuration to a deployed configuration to position the one or more electrodes to deliver electrical stimulation to tissue of the patient or sense a patient parameter from a location within the blood vessel.

[0186] Example 3: The endovascular medical device system of example 2, wherein the one or more electrodes includes an array of electrodes including at least six electrodes, and wherein in the deployed configuration, electrodes of the array of electrodes are disposed at multiple axial locations along the central longitudinal axis of the expandable structure and disposed at multiple circumferential locations around the expandable structure.

[0187] Example 4: The endovascular medical device system of any of examples 1 through 3, wherein at least one aperture of the one or more apertures defines a noncircular shape.

[0188] Example 5: The endovascular medical device system of any of examples 1 through 4, wherein at least one aperture of the one or more apertures includes at least one straight edge and at least one curved edge.

[0189] Example 6: The endovascular medical device system of any of examples 1 through 5, further comprising an electrically insulative material positioned between at least one electrode of the one or more electrodes and the expandable structure. Docket No. A0012241W001

[0190] Example 7: The endovascular medical device system of example 6, wherein the electrically insulative material comprises one or more electrically insulative structures, wherein at least a portion of each electrically insulative structure of the one or more electrically insulative structures is positioned between a respective electrode and the expandable structure and is configured to electrically insulate the respective electrode from the expandable structure.

[0191] Example 8: The endovascular medical device system of example 7, wherein each electrically insulative structure of the one or more electrically insulative structures includes a body portion and at least one flange portion, the at least one flange portion extending radially outward from the body portion, and wherein the body portion is configured to be received by and positioned in a respective aperture of the one or more apertures of the expandable structure.

[0192] Example 9: The endovascular medical device system of example 8, wherein the at least one flange portion of the electrically insulative structure includes at least a first flange portion and a second flange portion, wherein the expandable structure defines at least a first face and a second face opposite the first face, and wherein when each electrically insulative structure is received by and positioned in the respective aperture of the one or more apertures, the first flange portion abuts at least a portion of the first face of the expandable structure and the second flange portion abuts at least a portion of the second face of the expandable structure.

[0193] Example 10: The endovascular medical device system of any of examples 1 through 9, further includes one or more conductor wires, each conductor wire of the one or more conductor wires configured to electrically connect to at least one electrode of the one or more electrodes; and one or more crimp structures, each crimp structure of the one or more crimp structures configured to mechanically couple a portion of a respective conductor wire of the one or more conductor wires to at least one electrode, wherein each crimp structure of the one or more crimp structures is configured to pass through a respective aperture of the one or more apertures.

[0194] Example 11 : The endovascular medical device system of example 10, wherein at least one crimp structure of the one or more crimp structures defines a tapered profile.

[0195] Example 12: The endovascular medical device system of any of examples 1 through 11, further comprising one or more electrode fixation elements, an electrode fixation element of the one or more electrode fixation elements being configured to be received by a respective aperture of the expandable structure and configured to Docket No. A0012241W001 mechanically couple to a respective electrode of the one or more electrodes, wherein when the electrode fixation element is received by the respective aperture and mechanically coupled to the respective electrode, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

[0196] Example 13: The endovascular medical device system of example 12, wherein the electrode fixation element defines a cross-sectional profile such that when the electrode fixation element is received by the respective aperture, the respective aperture is configured to limit or prevent rotation of the electrode fixation element relative to the expandable structure.

[0197] Example 14: The endovascular medical device system of any of examples 12 and 13, wherein the electrode fixation element includes a fixation element body portion and at least one fixation element flange portion, the at least one fixation element flange portion extending radially outward from the fixation element body portion, and wherein when the electrode fixation element is positioned in the respective aperture and mechanically coupled to the respective electrode, the at least one fixation element flange portion is configured to anchor the respective electrode to the expandable structure.

[0198] Example 15: The endovascular medical device system of any of examples 12 through 14, wherein at least one electrode of the one or more electrodes defines a hole, the hole configured to receive a portion of an electrode fixation element of the one or more electrode fixation elements.

[0199] Example 16: The endovascular medical device system of any of examples 1 through 15, wherein at least one electrode of the one or more electrodes defines a beveled edge.

[0200] Example 17: The endovascular medical device system of any of examples 1 through 16, wherein the expandable frame comprises a plurality of connected struts, and wherein at least some struts of the plurality of connected struts define the one or more apertures.

[0201] Example 18: A method of using a medical device system includes introducing a medical device into vasculature of a patient, the medical device includes an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure including an expandable frame defining one or more apertures, wherein the expandable structure defines a central longitudinal axis; and one or more electrodes, each electrode of the one or more electrodes mechanically coupled to the expandable structure via a respective aperture of Docket No. A0012241W001 the one or more apertures, wherein each electrode of the one or more electrodes defines a first maximum dimension in a first direction along the central longitudinal axis of the expandable structure and a second maximum dimension in a second direction transverse to the first direction, wherein the first maximum dimension is greater than the second maximum dimension, and wherein when each electrode of the one or more electrodes is mechanically coupled to the expandable structure via the respective aperture, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure; and advancing the medical device until the one or more electrodes are at or near a target location in the vasculature of the patient.

[0202] Example 19: The method of example 18, wherein the expandable structure is configured to expand radially outwards from a relatively low-profile delivery configuration to a deployed configuration to position the one or more electrodes to deliver electrical stimulation to tissue of the patient or sense a patient parameter from a location within the blood vessel.

[0203] Example 20: The method of example 19, wherein the one or more electrodes includes an array of electrodes including at least six electrodes, and wherein in the deployed configuration, electrodes of the array of electrodes are disposed at multiple axial locations along the central longitudinal axis of the expandable structure and disposed at multiple circumferential locations around the expandable structure.

[0204] Example 21 : The method of any of examples 18 through 20, wherein at least one aperture of the one or more apertures defines a non-circular shape.

[0205] Example 22: The method of any of examples 18 through 21, wherein at least one aperture of the one or more apertures includes at least one straight edge and at least one curved edge.

[0206] Example 23: The method of any of examples 18 through 22, wherein the medical device further comprises an electrically insulative material positioned between at least one electrode of the one or more electrodes and the expandable structure.

[0207] Example 24: The method of example 23, wherein the electrically insulative material comprises one or more electrically insulative structures, wherein at least a portion of each electrically insulative structure of the one or more electrically insulative structures is positioned between a respective electrode and the expandable structure and is configured to electrically insulate the respective electrode from the expandable structure. [0208] Example 25: The method of example 24, wherein each electrically insulative structure of the one or more electrically insulative structures includes a body portion and Docket No. A0012241W001 at least one flange portion, the at least one flange portion extending radially outward from the body portion, and wherein the body portion is configured to be received by and positioned in a respective aperture of the one or more apertures of the expandable structure.

[0209] Example 26: The method of example 25, wherein the at least one flange portion of the electrically insulative structure includes at least a first flange portion and a second flange portion, wherein the expandable structure defines at least a first face and a second face opposite the first face, and wherein when each electrically insulative structure is received by and positioned in the respective aperture of the one or more apertures, the first flange portion abuts at least a portion of the first face of the expandable structure and the second flange portion abuts at least a portion of the second face of the expandable structure.

[0210] Example 27: The method of any of examples 18 through 26, wherein the medical device further comprises: one or more conductor wires, each conductor wire of the one or more conductor wires configured to electrically connect to at least one electrode of the one or more electrodes; and one or more crimp structures, each crimp structure of the one or more crimp structures configured to mechanically couple a portion of a respective conductor wire of the one or more conductor wires to at least one electrode, wherein each crimp structure of the one or more crimp structures is configured to pass through a respective aperture of the one or more apertures.

[0211] Example 28: The method of example 27, wherein at least one crimp structure of the one or more crimp structures defines a tapered profile.

[0212] Example 29: The method of any of examples 18 through 28, wherein the medical device further comprises one or more electrode fixation elements, an electrode fixation element of the one or more electrode fixation elements being configured to be received by a respective aperture of the expandable structure and configured to mechanically couple to a respective electrode of the one or more electrodes, wherein when the electrode fixation element is received by the respective aperture and mechanically coupled to the respective electrode, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

[0213] Example 30: The method of example 29, wherein the electrode fixation element defines a cross-sectional profile such that when the electrode fixation element is received by the respective aperture, the respective aperture is configured to limit or prevent rotation of the electrode fixation element relative to the expandable structure. Docket No. A0012241W001

[0214] Example 31 : The method of any of examples 29 and 30, wherein the electrode fixation element includes a fixation element body portion and at least one fixation element flange portion, the at least one fixation element flange portion extending radially outward from the fixation element body portion, and wherein when the electrode fixation element is positioned in the respective aperture and mechanically coupled to the respective electrode, the at least one fixation element flange portion is configured to anchor the respective electrode to the expandable structure.

[0215] Example 32: The method of any of examples 29 through 31, wherein at least one electrode of the one or more electrodes defines a hole, the hole configured to receive a portion of an electrode fixation element of the one or more electrode fixation elements. [0216] Example 33: The method of any of examples 18 through 32, wherein at least one electrode of the one or more electrodes defines a beveled edge.

[0217] Example 34: The method of any of examples 18 through 33, wherein the expandable frame comprises a plurality of connected struts, and wherein at least some struts of the plurality of connected struts define the one or more apertures.

[0218] Example 35: An endovascular medical device system includes an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure including an expandable frame defining one or more apertures, each aperture of the one or more apertures defining a non-circular shape, wherein the expandable structure defines a central longitudinal axis; one or more electrodes, each electrode of the one or more electrodes mechanically coupled to the expandable structure via a respective aperture of the one or more apertures; and an electrically insulative material positioned between at least one electrode of the one or more electrodes and the expandable structure; and one or more electrode fixation elements, each respective electrode fixation element configured to be received by a respective aperture of the expandable structure and configured to mechanically couple to a respective electrode of the one or more electrodes, wherein each electrode of the one or more electrodes defines a first maximum dimension in a first direction along the central longitudinal axis of the expandable structure and a second maximum dimension in a second direction transverse to the first direction, wherein the first maximum dimension is greater than the second maximum dimension, wherein when each electrode of the one or more electrodes is mechanically coupled to the expandable structure via the respective aperture, and wherein when the respective electrode fixation element is received by the respective aperture and mechanically coupled to the respective electrode of the one or Docket No. A0012241W001 more electrodes, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

[0219] Example 36: The endovascular medical device system of example 35, further includes a conductor wire configured to electrically connect to at least one electrode of the one or more electrodes; and a crimp structure configured to mechanically couple a portion of the conductor wire to the at least one electrode, wherein the crimp structure is configured to pass through a respective aperture of the one or more apertures.

[0220] Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

Claims

Docket No. A0012241W001 WHAT IS CLAIMED IS:

1. An endovascular medical device system comprising: an elongated body configured to be introduced in a blood vessel of a patient; an expandable structure at a distal portion of the elongated body, the expandable structure including an expandable frame defining one or more apertures, wherein the expandable structure defines a central longitudinal axis; and one or more electrodes, each electrode of the one or more electrodes mechanically coupled to the expandable structure via a respective aperture of the one or more apertures, wherein each electrode of the one or more electrodes defines a first maximum dimension in a first direction along the central longitudinal axis of the expandable structure and a second maximum dimension in a second direction transverse to the first direction, wherein the first maximum dimension is greater than the second maximum dimension, and wherein when each electrode of the one or more electrodes is mechanically coupled to the expandable structure via the respective aperture, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

2. The endovascular medical device system of claim 1, wherein the expandable structure is configured to expand radially outwards from a relatively low-profile delivery configuration to a deployed configuration to position the one or more electrodes to deliver electrical stimulation to tissue of the patient or sense a patient parameter from a location within the blood vessel.

3. The endovascular medical device system of claim 2, wherein the one or more electrodes includes an array of electrodes including at least six electrodes, and wherein in the deployed configuration, electrodes of the array of electrodes are disposed at multiple axial locations along the central longitudinal axis of the expandable structure and disposed at multiple circumferential locations around the expandable structure. Docket No. A0012241W001

4. The endovascular medical device system of any of claims 1 through 3, wherein at least one aperture of the one or more apertures defines a non-circular shape.

5. The endovascular medical device system of any of claims 1 through 4, wherein at least one aperture of the one or more apertures includes at least one straight edge and at least one curved edge.

6. The endovascular medical device system of any of claims 1 through 5, further comprising an electrically insulative material positioned between at least one electrode of the one or more electrodes and the expandable structure.

7. The endovascular medical device system of any of claim 6, wherein the electrically insulative material comprises one or more electrically insulative structures, wherein at least a portion of each electrically insulative structure of the one or more electrically insulative structures is positioned between a respective electrode and the expandable structure and is configured to electrically insulate the respective electrode from the expandable structure.

8. The endovascular medical device system of claim 7, wherein each electrically insulative structure of the one or more electrically insulative structures includes a body portion and at least one flange portion, the at least one flange portion extending radially outward from the body portion, and wherein the body portion is configured to be received by and positioned in a respective aperture of the one or more apertures of the expandable structure.

9. The endovascular medical device system of claim 8, wherein the at least one flange portion of the electrically insulative structure includes at least a first flange portion and a second flange portion, wherein the expandable structure defines at least a first face and a second face opposite the first face, and wherein when each electrically insulative structure is received by and positioned in the respective aperture of the one or more apertures, the first flange portion abuts at least a portion of the first face of the expandable structure and the second flange portion abuts at least a portion of the second face of the expandable structure. Docket No. A0012241W001

10. The endovascular medical device system of any of claims 1 through 9, further comprising: one or more conductor wires, each conductor wire of the one or more conductor wires configured to electrically connect to at least one electrode of the one or more electrodes; and one or more crimp structures, each crimp structure of the one or more crimp structures configured to mechanically couple a portion of a respective conductor wire of the one or more conductor wires to at least one electrode, wherein each crimp structure of the one or more crimp structures is configured to pass through a respective aperture of the one or more apertures.

11. The endovascular medical device system of any of claims 1 through 10, further comprising one or more electrode fixation elements, an electrode fixation element of the one or more electrode fixation elements being configured to be received by a respective aperture of the expandable structure and configured to mechanically couple to a respective electrode of the one or more electrodes, wherein when the electrode fixation element is received by the respective aperture and mechanically coupled to the respective electrode, the respective aperture is configured to limit rotation of the respective electrode relative to the expandable structure.

12. The endovascular medical device system of claim 11, wherein the electrode fixation element defines a cross-sectional profile such that when the electrode fixation element is received by the respective aperture, the respective aperture is configured to limit or prevent rotation of the electrode fixation element relative to the expandable structure.

13. The endovascular medical device system of any of claims 11 and 12, wherein the electrode fixation element includes a fixation element body portion and at least one fixation element flange portion, the at least one fixation element flange portion extending radially outward from the fixation element body portion, and wherein when the electrode fixation element is positioned in the respective aperture and mechanically coupled to the respective electrode, the at least one fixation Docket No. A0012241W001 element flange portion is configured to anchor the respective electrode to the expandable structure.

14. The endovascular medical device system of any of claims 11 through 13, wherein at least one electrode of the one or more electrodes defines a hole, the hole configured to receive a portion of an electrode fixation element of the one or more electrode fixation elements.

15. The endovascular medical device system of any of claims 1 through 14, wherein at least one electrode of the one or more electrodes defines a beveled edge.