Leads with segmented electrodes

Abstract

A device according to at least one embodiment of the present disclosure includes: a distal end; a proximal end; an electrode positioned between the distal end and the proximal end, the electrode including: a first portion and a second portion segmented from the first portion, the first portion including at least one retention feature; an insulative material positioned between the first portion and the second portion to electrically isolate the first portion from the second portion; and an aperture extending through the electrode; and a group of wires extending through at least a portion of the aperture, wherein a first wire of the group of wires is electrically connected to the first portion, and wherein a second wire of the group of wires is electrically connected to the second portion.

Description

Attorney Docket No. A0012660W001LEADS WITH SEGMENTED ELECTRODESCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority to U.S. Provisional ApplicationNo. 63 / 708,190 filed October 16, 2024, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] The present disclosure is generally directed to electrical stimulation therapy, and relates more particularly to segmented electrodes for delivering electrical stimulation therapies.

[0003] Medical devices may be external or implanted, and may be used to deliver electrical stimulation therapy to various tissue sites of a patient to treat a variety of symptoms or conditions such as chronic pain, tremors, Parkinson’s disease, other movement disorders, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. A medical device delivers electrical stimulation therapy via one or more leads that include electrodes located proximate to target locations associated with the brain, the spinal cord, pelvic nerves, peripheral nerves, or the gastrointestinal tract of a patient. Electrical stimulation is used in different therapeutic applications, such as Deep Brain Stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS).BRIEF SUMMARY

[0004] Implantable medical leads may be implanted to provide DBS therapies to targets within the brain. According to at least one embodiment of the present disclosure, an implantable medical lead may comprise a circumferentially-segmented electrode that includes one or more retention features that hold portions of the electrode in place during use. In one example, the one or more retention features may comprise concave portions that can be filled with a polymer when the electrode is overmolded with the polymer. In another example, the one or more retention features may comprise one or more apertures that can be at least partially filled with the polymer when the electrode is overmolded with the polymer. In yet another example, the one or more retention features may comprise one or more tabs that couple with the polymer when the electrode is overmolded with the polymer.

[0005] Example aspects of the present disclosure include:

[0006] A device according to at least one embodiment of the present disclosure comprises: a distal end; a proximal end; an electrode positioned between the distal end and the proximal end, the electrode comprising: a first portion and a second portion segmented from the first portion, the first portion comprising at least one retention feature; an insulative material positioned between the first portion and the second portion to electrically isolate the first portion from theAttorney Docket No. A0012660W001 second portion; and an aperture extending through the electrode; and a plurality of wires extending through at least a portion of the aperture, wherein a first wire of the plurality of wires is electrically connected to the first portion, and wherein a second wire of the plurality of wires is electrically connected to the second portion.

[0007] Any of the aspects herein, wherein the second portion is circumferentially segmented from the first portion.

[0008] Any of the aspects herein, wherein the at least one retention feature comprises a concave portion that is at least partially filled by the insulative material.

[0009] Any of the aspects herein, wherein the plurality of wires is coiled.

[0010] Any of the aspects herein, wherein the at least one retention feature comprises an aperture that is at least partially filled by the insulative material.

[0011] Any of the aspects herein, wherein a thickness of the insulative material positioned between the first portion and the second portion varies along a first direction.

[0012] Any of the aspects herein, wherein the insulative material comprises polyether urethane.

[0013] Any of the aspects herein, wherein the electrode further comprises a third portion that is electrically isolated from the first portion and from the second portion by the insulative material.

[0014] Any of the aspects herein, wherein the first portion and the third portion each comprises a concave portion that is filled by the insulative material.

[0015] Any of the aspects herein, wherein the third portion is circumferentially segmented from the first portion and from the second portion.

[0016] Any of the aspects herein, wherein a third wire of the plurality of wires is electrically connected to the third portion.

[0017] Any of the aspects herein, wherein at least one wire of the plurality of wires extends beyond the electrode and toward the distal end.

[0018] A lead according to at least one embodiment of the present disclosure comprises: a distal end; a proximal end; an electrode positioned between the distal end and the proximal end, the electrode comprising: a first portion and a second portion segmented from the first portion, the first portion comprising a retention feature; an insulative material positioned between the first portion and the second portion to electrically isolate the first portion from the second portion, wherein the insulative material couples with the retention feature; and an aperture extending through the electrode; and a plurality of wires extending through at least a portion of the aperture, wherein a first wire of the plurality of wires is electrically connected to the first portion, and wherein a second wire of the plurality of wires is electrically connected to the second portion.

[0019] Any of the aspects herein, wherein the second portion is circumferentially segmented from the first portion.Attorney Docket No. A0012660W001

[0020] Any of the aspects herein, wherein the retention feature comprises a concave portion that is at least partially filled by the insulative material.

[0021] Any of the aspects herein, wherein the plurality of wires is coiled.

[0022] Any of the aspects herein, wherein the retention feature comprises an aperture, and wherein the insulative material is at least partially positioned within the aperture.

[0023] Any of the aspects herein, wherein a thickness of the insulative material positioned between the first portion and the second portion varies along a first direction.

[0024] An implantable lead according to at least one embodiment of the present disclosure comprises: a distal end; a proximal end; an electrode positioned between the distal end and the proximal end, the electrode comprising: a first portion, a second portion, and a third portion segmented from the first portion and from the second portion, the third portion comprising a retention feature; an insulative material that electrically isolates the third portion from the first portion and from the second portion, wherein the insulative material couples with the retention feature; and an aperture extending through the electrode; and a plurality of wires extending through at least a portion of the aperture, wherein a first wire of the plurality of wires is electrically connected to the first portion, and wherein a second wire of the plurality of wires is electrically connected to the second portion.

[0025] Any of the aspects herein, wherein a thickness of the insulative material positioned between the first portion and the third portion varies along a first direction.

[0026] Any aspect in combination with any one or more other aspects.

[0027] Any one or more of the features disclosed herein.

[0028] Any one or more of the features as substantially disclosed herein.

[0029] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0030] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments.

[0031] Use of any one or more of the aspects or features as disclosed herein.

[0032] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0033] 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 advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.Attorney Docket No. A0012660W001

[0034] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as Xl-Xn, Yl- Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0035] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0036] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0037] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0038] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0039] Fig. l is a conceptual diagram of aspects of a system according to at least one embodiment of the present disclosure;Attorney Docket No. A0012660W001

[0040] Fig. 2A is an isometric view of aspects of a lead according to at least one embodiment of the present disclosure;

[0041] Fig. 2B is a cross-section view of a portion of the lead according to at least one embodiment of the present disclosure;

[0042] Fig. 2C is a view of aspects of a distal end of the lead according to at least one embodiment of the present disclosure;

[0043] Fig. 3 A is an isometric view of an electrode according to at least one embodiment of the present disclosure;

[0044] Fig. 3B is a cross-section view of the electrode after molding according to at least one embodiment of the present disclosure;

[0045] Fig. 3C is a cross-section view of the electrode after grinding according to at least one embodiment of the present disclosure;

[0046] Fig. 4A is an isometric view of an electrode according to at least one embodiment of the present disclosure;

[0047] Fig. 4B is a cross-section view of the electrode after molding according to at least one embodiment of the present disclosure;

[0048] Fig. 4C is a cross-section view of the electrode after grinding according to at least one embodiment of the present disclosure;

[0049] Fig. 4D is a detailed cross-section view of a portion of the electrode after grinding according to at least one embodiment of the present disclosure;

[0050] Fig. 5A is an isometric view of an electrode according to at least one embodiment of the present disclosure;

[0051] Fig. 5B is a cross-section view of the electrode after molding according to at least one embodiment of the present disclosure;

[0052] Fig. 5C is a cross-section view of the electrode after grinding according to at least one embodiment of the present disclosure;

[0053] Fig. 5D is a detailed cross-section view of a portion of the electrode after grinding according to at least one embodiment of the present disclosure;

[0054] Fig. 6 is a diagram of aspects of an implantable medical device (IMD) according to at least one embodiment of the present disclosure;

[0055] Fig. 7 is a diagram of aspects of an external programmer according to at least one embodiment of the present disclosure; and

[0056] Fig. 8 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTIONAttorney Docket No. A0012660W001

[0057] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0058] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0059] DBS therapies aim to provide stimulation to targets within the brain, such as the subthalamic nucleus, while minimizing stimulation elsewhere which may cause adverse side effects and / or excessive power consumption. According to at least one embodiment of the present disclosure, one solution comprises using circumferentially-segmented electrodes instead of circumferential electrodes. The circumferentially-segmented electrode design may enable each electrode to be controlled independently such that the electric field created by the electrodes to be steered directionally which in turn helps minimize stimulation side effects.

[0060] According to embodiments of the present disclosure, various design concepts of electrodes are provided. The electrodes can be segmented into three electrodes after centerless grinding for use in DBS therapy and other therapies. The designs includes features (e.g., retention features) that enable the electrode to be attached to an individual conductor wires and reliably retained within a lead assembly. In one example, the one or more retention features may comprise concave portions that can be filled with a polymer when the electrode is molded with the polymer. In another example, the one or more retention features may comprise one or more apertures that can be at least partially filled with the polymer when the electrode is molded with the polymer. In yet another example, the one or more retention features may comprise one or more tabs that couple with the polymer when the electrode is molded with the polymer.Attorney Docket No. A0012660W001

[0061] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) excessive electrode power consumption, and (2) electrodes falling off or separating from the lead assembly after molding and grinding.

[0062] Turning first to Fig. 1, aspects of a conceptual diagram illustrating a system 100 are shown in accordance with embodiments of the present disclosure. The conceptual diagram depicts an implantable medical device (IMD) 106 configured to deliver a DBS therapy to a patient 112. In some examples, the DBS may be closed-loop in the sense that the IMD 106, as one example, may adjust, increase, or decrease the magnitude of one or more parameters of the DBS in response to changes in patient activity or movement, a severity of one or more symptoms of a disease of the patient, a presence of one or more side effects due to the DBS, and / or one or more sensed signals of the patient.

[0063] In one example, the system 100 comprises a bi-directional DBS system with capabilities to both deliver stimulation, sense intrinsic neuronal signals, and sense neural signals that are evoked in response to delivery of stimulation. The system 100 may be configured to treat a patient condition, such as a movement disorder (e.g., ET, Parkinson’s, etc.), neurodegenerative impairment, a mood disorder, or a seizure disorder of the patient 112. The patient 112 is ordinarily a human patient. In some cases, however, the system 100 may be applied to other mammalian or non-mammalian, non-human patients. While movement disorders and neurodegenerative impairment are primarily referred to herein, in other examples, the system 100 may provide therapy to manage symptoms of other patient conditions, such as, but not limited to, seizure disorders (e.g., epilepsy) or mood (or psychological) disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD)). At least some of these disorders may be manifested in one or more patient movement behaviors. As described herein, a movement disorder or other neurodegenerative impairment may include symptoms such as, for example, muscle control impairment, motion impairment or other movement problems, such as rigidity, spasticity, bradykinesia, rhythmic hyperkinesia, nonrhythmic hyperkinesia, and akinesia. In some cases, the movement disorder may be a symptom of Parkinson’s disease or ET. However, the movement disorder may be attributable to other conditions of the patient.

[0064] The system 100 is illustrated to comprise a programmer 104, the IMD 106, a lead extension 110, a lead 114A with a set of electrodes 116, and a lead 114B with a set of electrodes 118.

[0065] In the example shown in Fig. 1, the electrodes 116, 118 of the leads 114A, 114B are positioned to deliver electrical stimulation to a tissue site within the brain 120 of the patient 112, such as a deep brain site under the dura mater of the brain 120 of the patient 112. The IMD 106Attorney Docket No. A0012660W001 may be implanted within a subcutaneous pocket above the clavicle, or, alternatively, on or within the cranium 122 or at any other suitable site within the patient 112. Generally, the IMD 106 is constructed of a biocompatible material that resists corrosion and degradation from bodily fluids. The IMD 106 may comprise a hermetic housing to substantially enclose components, such as a processor, therapy module, and memory. In some examples, delivery of stimulation to one or more regions of the brain 120, such as the subthalamic nucleus (STN), globus pallidus or thalamus, ventralus intermediate (VIM), anterior nucleus (ANT), ventral internal capsule / ventral striatum (VCVS), cortico-basal ganglia-thalamocortical circuit, or anterior insular cortex (AIC), may be an effective treatment to manage disorders, such as Parkinson’s disease.

[0066] Some or all of the electrodes 116, 118 also may be positioned to sense neurological brain signals within the brain 120 of the patient 112. In some examples, some of the electrodes 116, 118 may be configured to sense neurological brain signals and others of the electrodes 116, 118 may be configured to deliver electrical stimulation to the brain 120. In other examples, all of the electrodes 116, 118 are configured to both sense neurological brain signals and deliver electrical stimulation to the brain 120. In some examples, unipolar stimulation may be possible where one electrode is on the housing of the IMD 106. Although the IMD 106 is described as delivering electrical stimulation therapy to the brain 120, the IMD 106 may be configured to direct electrical stimulation to other anatomical regions of the patient 112. Further, an IMD may provide other electrical stimulation such as spinal cord stimulation to treat a movement disorder.

[0067] The IMD 106 includes a therapy module (e.g., which may include processing circuitry or other electrical circuitry configured to perform the functions attributed to the IMD 106) that includes stimulation generation circuitry configured to generate and deliver electrical stimulation therapy to the patient 112 via a subset of the electrodes 116, 118 of the leads 114A and 114B, respectively. The subset of the electrodes 116, 118 that are used to deliver electrical stimulation to the patient 112, and, in some cases, the polarity of the subset of the electrodes 116, 118, may be referred to as a stimulation electrode combination. In some examples, the stimulation electrode combination can be selected for a particular patient and target tissue site (e.g., selected based on the patient condition). The group of the electrodes 116, 118 includes at least one electrode and can include a plurality of electrodes. In some examples, the plurality of the electrodes 116 and / or 118 may have a complex electrode geometry such that two or more electrodes are located at different positions around the perimeter of the respective lead.

[0068] In some examples, the neurological signals sensed within the brain 120 may reflect changes in electrical current produced by the sum of electrical potential differences across brain tissue. There may be various examples of neurological brain signals that the electrodes 116, 118 may be configured to sense. One example of a neurological brain signal is an Evoked ResonantAttorney Docket No. A0012660W001Neural Activity (ERNA) signal, which may be evoked through delivery of electrical stimulation within the brain 120. The electrical stimulation delivered within brain 120 to evoke the ERNA signal need not necessarily provide therapeutic benefit, but therapeutic benefit from the electrical stimulation used to evoke the ERNA signal is possible. Electroencephalogram (EEG) signals, electrocorticogram (ECoG) signals, or local field potential (LFP) signals are also examples of neurological signals that may be sensed by the IMD 106. For example, neurons generate the neurological signals, and if measured at depth, it is LFP or ERNA (if evoked); if measured on the dura, it is ECoG; and if on scalp, it is EEG. In another example, the neurological signals may be or comprise Evoked Compound Action Potential (ECAP) signals.

[0069] In some examples, the neurological brain signals that are used to select a stimulation electrode combination may be sensed within the same region of the brain 120 as the target tissue site for the electrical stimulation. As previously indicated, the target tissue sites may include tissue sites within anatomical structures such as the thalamus, STN, or globus pallidus of the brain 120, as well as other target tissue sites. The specific target tissue sites and / or regions within the brain 120 may be selected based on the patient’s condition. Thus, in some examples, both a stimulation electrode combination and sense electrode combinations may be selected from the same set of the electrodes 116, 118. In other examples, the electrodes used for delivering electrical stimulation may be different than the electrodes used for sensing neurological brain signals.

[0070] Therapeutic electrical stimulation generated by the IMD 106 may be configured to manage a variety of disorders and conditions. In some examples, the stimulation generation circuitry of the IMD 106 is configured to generate and deliver therapeutic electrical stimulation pulses to the patient 112 via electrodes of a selected stimulation electrode combination. However, in other examples, the stimulation generation circuitry of the IMD 106 may be configured to generate and deliver a continuous wave signal (e.g., a sine wave or triangle wave). In either case, stimulation generation circuitry within the IMD 106 may generate the electrical stimulation therapy for DBS according to a selected therapy program. In examples in which the IMD 106 delivers therapeutic electrical stimulation in the form of stimulation pulses, a therapy program may include a set of therapy parameter values (e.g., parameters), such as a stimulation electrode combination for delivering stimulation to the patient 112, pulse frequency, pulse width, and a current or voltage amplitude of the pulses. As previously indicated, the electrode combination may indicate the specific electrodes 116, 118 that are selected to deliver therapeutic stimulation signals to tissue of the patient 112 and the respective polarities of the selected electrodes.

[0071] In some examples, the electrodes 116, 118 may be circumferentially-segmented DBS arrays of electrodes, and include some non-segmented electrodes as well, such as ring electrodes.Attorney Docket No. A0012660W001Circumferentially-segmented DBS arrays refer to electrodes that are segmented circumferentially along the lead. As one example, the leads 114A and 114B may include a first set of electrodes arranged circumferentially around the leads 114A and 114B that are all at the same height level on the leads 114A and 114B. Each of the electrodes in the first set of electrodes is a separate segmented electrode and form a level of circumferentially-segmented array of electrodes. The leads 114A and 114B may include a second set of electrodes arranged circumferentially around the leads 114A and 114B that are all at the same height level on the leads 114A and 114B. Each of the electrodes in the first set of electrodes is a separate segmented electrode and forms a level of circumferentially-segmented array of electrodes. The electrodes may be beneficial by enabling directional stimulation and sensing. In some cases, the first and second sets of electrodes may evoke and measure signal responses from various anatomical tissues in the brain 120 of the patient 112.

[0072] With the electrodes, the IMD 106 may be configured to perform both directional stimulation and sensing, thereby enhancing the ability to target the source of the ERNA activities (also referred to as pathological neuronal activities) and / or to deliver stimulation for a DBS therapy or other therapy. For example, the IMD 106 may be configured to perform directional sensing to determine a direction and / or orientation of the ERNA source (e.g., signal source that generates the ERNA). The IMD 106 may direct the electrical stimulation toward the signal source to optimize the ERNA signal component produced by the signal source (e.g., amplitude, frequency, etc.), as one example. In another example, the IMD 106 may determine a direction and / or orientation of the ERNA source, and may use such information along with information about the current pose of the leads 114A and 114B to determine whether the leads 114A and 114B are correctly placed at a target location. For instance, the IMD 106 may receive ERNA responses from surrounding anatomical tissue and, using processing circuitry, determine a location of target nuclei that are to receive directional stimulation. The processing circuitry may further compare the location of the target nuclei to the location of the leads 114A and 114B (or the electrodes 116, 118) and, when a difference between the location of the target nuclei and the location of the leads 114A and 114B meet or exceed a threshold value, generate an alert indicating that the leads 114A and 114B have not been implanted in the correct location. Such an alert may enable a physician, the patient 112, or the like to adjust the implant location of the leads 114A and 114B, adjust which electrodes of the electrodes 116, 118 are used to perform the stimulation, combinations thereof, and / or the like.

[0073] As shown in Fig. 1, the lead extension 110 is coupled to the IMD 106 via a connector 108 (also referred to as a connector block or a header of the IMD 106). In the example of Fig. 1, the lead extension 110 traverses from the implant site of the IMD 106 and along the neck of theAttorney Docket No. A0012660W001 patient 112 to the cranium 122 of the patient 112 to access the brain 120. The lead extension 110 comprises a distal connector, which enables the leads 114A and 114B to connect to the IMD 106. In the example shown in Fig. 1, the leads 114A and 114B (collectively the “leads 114”) are implanted within the right and left hemispheres (or in just one hemisphere in some examples), respectively, of the patient 112 in order to deliver electrical stimulation to one or more regions of the brain 120, which may be selected based on the patient condition or disorder controlled by the system 100. The specific target tissue site and the stimulation electrodes used to deliver stimulation to the target tissue site, however, may be selected, e.g., according to the identified patient behaviors and / or other sensed patient parameters. Other implant sites of the leads 114A, 114B and the IMD 106 are contemplated. For example, the IMD 106 may be implanted on or within the cranium 122, in some examples. The leads 114A and 114B may be implanted within the same hemisphere or the IMD 106 may be coupled to a single lead implanted in a single hemisphere, in some examples. Existing lead sets include axial leads carrying ring electrodes disposed at different axial positions and so-called "paddle" leads carrying planar arrays of electrodes. In some examples, more complex lead array geometries may be used.

[0074] Although the leads 114 are shown in Fig. 1 as being coupled to a common lead extension, in other examples, the leads 114 may be coupled to the IMD 106 via separate lead extensions. The leads 114 may be positioned to deliver electrical stimulation to one or more target tissue sites within the brain 120 to deliver a DBS or other therapy to the patient 112. The leads 114 may be implanted to position the electrodes 116, 118 at desired locations of the brain 120 through respective holes in the cranium 122. The leads 114 may be placed at any location within the brain 120 such that the electrodes 116, 118 are capable of providing electrical stimulation to target tissue sites within the brain 120 during treatment. For example, the electrodes 116, 118 may be surgically implanted under the dura mater of the brain 120 or within the cerebral cortex of the brain 120 via a burr hole in the cranium 122 of the patient 112, and electrically coupled to the IMD 106 via one or more leads (e.g., the leads 114).

[0075] In the example shown in Fig. 1, the electrodes 116, 118 of the leads 114 are shown as ring electrodes. In other examples, the electrodes 116, 118 may have different configurations. For example, at least some of the electrodes 116, 118 of the leads 114 may have a complex electrode array geometry that is capable of producing shaped electrical fields. The complex electrode array geometry may include multiple portions (e.g., circumferentially-segmented portions) around the outer perimeter of each lead 114, rather than one ring electrode. In this manner, electrical stimulation may be directed in a specific direction from the leads 114 to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue. For example, one or more electrodes 116, 118 may be circumferentially-segmented DBS arrays of electrodes,Attorney Docket No. A0012660W001 and one or more electrodes 116, 118 may be non-segmented electrodes such as ring electrodes, as described above. In some examples, the leads 114 may have shapes other than elongated cylinders as shown in Fig. 1.

[0076] The IMD 106 includes a memory to store a plurality of therapy programs that each define a set of therapy parameter values. In some examples, the IMD 106 may select a therapy program from the memory based on various parameters, such as sensed patient parameters and the identified patient behaviors. The stimulation generation circuitry of the IMD 106 may deliver a first set of one or more therapeutic electrical stimulation signals according to a first set of one or more parameters. Then, the processing circuitry may determine a second set of one or more parameters for a second set of one or more therapeutic electrical stimulation signals based on, for example, one or more ERNA signals and cause the stimulation generation circuitry to deliver the second set of the one or more therapeutic electrical stimulation signals. The second set of one or more parameters may comprise changes to the first set of one or more parameters.

[0077] The programmer 104 wirelessly communicates with the IMD 106 as needed to provide or retrieve therapy information. The programmer 104 is an external computing device that the user, (e.g., a clinician and / or the patient 112), may use to communicate with the IMD 106. For example, the programmer 104 may be a clinician programmer that the clinician uses to communicate with the IMD 106 and program one or more therapy programs for the IMD 106. Alternatively, the programmer 104 may be a patient programmer that allows the patient 112 to select programs and / or view and modify therapy parameters. The clinician programmer may include more programming features than the patient programmer. In other words, more complex and sensitive tasks may be reserved for the clinician programmer to prevent an untrained patient from making undesirable changes to the IMD 106.

[0078] When the programmer 104 is configured for use by the clinician, the programmer 104 may be used to transmit initial programming information to the IMD 106. This initial information may include hardware information, such as the type of leads and the electrode arrangement, the position of the leads 114 within the brain 120, the configuration of the electrodes 116, 118, initial programs defining therapy parameter values, and any other information the clinician desires to program into the IMD 106. The programmer 104 may also be capable of completing functional tests (e.g., measuring the impedance of the electrodes 116, 118 of the leads 114).

[0079] The clinician may also store therapy programs within the IMD 106 with the aid of the programmer 104. During a programming session, the clinician may determine one or more therapy programs that may provide efficacious therapy to the patient 112 to address symptoms associated with the patient condition, and, in some cases, specific to one or more different patient states, such as a sleep state, movement state or rest state. For example, the clinician may selectAttorney Docket No. A0012660W001 one or more stimulation electrode combinations with which stimulation is delivered to the brain 120. During the programming session, the clinician may evaluate the efficacy of the specific program being evaluated based on feedback provided by the patient 112 or based on one or more physiological parameters of the patient 112 (e.g., muscle activity, muscle tone, rigidity, tremor, etc.). Alternatively, identified patient behavior from video information may be used as feedback during the initial and subsequent programming sessions. The programmer 104 may assist the clinician in the creation / identification of therapy programs by providing a methodical system for identifying potentially beneficial therapy parameter values.

[0080] The programmer 104 may also be configured for use by the patient 112. When configured as a patient programmer, the programmer 104 may have limited functionality (compared to a clinician programmer) in order to prevent the patient 112 from altering critical functions of the IMD 106 or applications that may be detrimental to the patient 112. In this manner, the programmer 104 may only allow the patient 112 to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter.

[0081] The programmer 104 may also provide an indication to the patient 112 when therapy is being delivered, when patient input has triggered a change in therapy or when the power source within the programmer 104 or the IMD 106 needs to be replaced or recharged. For example, the programmer 104 may include an alert LED, may flash a message to the patient 112 via a programmer display, generate an audible sound or somatosensory cue to confirm patient input was received (e.g., to indicate a patient state or to manually modify a therapy parameter).

[0082] Turning next to Figs. 2A-2C, aspects of an example lead 200 are shown in accordance with at least one embodiment of the present disclosure. The lead 200 may in some cases be similar to or the same as the leads 114 A, 114B. For example, the lead 200 may be implantable into a surgical site of a patient to provide stimulation therapy (e.g., DBS therapy). The lead 200 is illustrated to comprise a proximal end 204 with a set of proximal electrodes 230A-230H and a distal end 208 with a set of distal electrodes 224A-224D. The lead 200 also comprises a housing 220 that extends along a longitudinal axis 202 (e.g., a Z-axis direction of coordinate system 206) between the proximal end 204 and the distal end 208. The housing 220 includes a plurality of wires 214A-214H wrapped in a coil 212 around a stylet lumen 216 that extends through the housing 220. In some cases, the stylet lumen 216 may be removable from the lead 200. In other cases, the stylet lumen 216 may be omitted from the lead 200 and the coil 212 may function as a lumen. The plurality of wires 214A-214H electrically connects the proximal electrodes 230A- 230H to the distal electrodes 224A-224D, such that signals received by the proximal electrodes 230A-230H (e.g., stimulation signals from the IMD 106) can be delivered to anatomical tissue proximate the distal electrodes 224A-224D. In one example, the plurality of wires 214A-214HAttorney Docket No. A0012660W001 may comprise a Platinum / Iridium material composition (e.g., 80% Platinum, 20% Iridium). However, in other examples, the plurality of wires 214A-214H may comprise alternative material compositions. It is to be understood that the lead 200 may in some examples comprise additional or alternative components to those depicted in Figs. 2A-2C. For example, the lead 200 may comprise one or more radiopaque markers or features that can be used to track the pose (e.g., position and orientation) of the lead 200, such as by capturing one or more images of the patient 112 after the lead 200 has been implanted into the patient 112 to confirm correct placement of the lead 200 at the surgical site.

[0083] In some cases, reference may be made to the dimensions, angles, directions, relative positions, and / or movements associated with one or more components of the lead 200 with respect to a coordinate system 206, 306, 406, or 506. The coordinate system 206, 306, 406, or 506 as shown in the accompanying figures, includes three dimensions comprising an X-axis, a Y- axis, and a Z-axis. Additionally or alternatively, the coordinate system 206, 306, 406, or 506 may be used to define planes (e.g., the XY-plane, the XZ-plane, and the YZ-plane) of the lead 200, electrode 302, electrode 402, or electrode 502. These planes may be disposed orthogonally, or at 90 degrees, to one another. While the origin of the coordinate system 206, 306, 406, or 506 may be placed at any point, for the purposes of description, the axes of the coordinate system 206, 306, 406, or 506 are disposed along the same directions from figure to figure. Additionally or alternatively, the directionality of the X-axis, the Y-axis, and the Z-axis may be flipped, as noted with negative directionality (e.g., the negative Z-axis direction is the opposite direction of the Z- axis direction illustrated by the direction of the associated arrow). In some cases, the coordinate system 206, 306, 406, or 506 may be defined based on or using cartesian coordinates, cylindrical coordinates, polar coordinates, combinations thereof, and / or the like.

[0084] The proximal electrodes 230A-230H may each be electrically connected to electrical wiring that extends to the IMD 106 via the lead extension 110 and may each facilitate delivery of stimulation signals from the IMD 106 to the distal electrodes 224A-224D. In one example, the proximal electrodes 230A-230H comprise eight electrodes: a first proximal electrode 230A, a second proximal electrode 230B, a third proximal electrode 230C, a fourth proximal electrode 230D, a fifth proximal electrode 230E, a sixth proximal electrode 23 OF, a seventh proximal electrode 230G, and an eighth proximal electrode 230H. In this example, the plurality of wires 214A-214H may comprise eight wires: a first wire 214A, a second wire 214B, a third wire 214C, a fourth wire 214D, a fifth wire 214E, a sixth wire 214F, a seventh wire 214G, and an eighth wire 214H. In some cases, the proximal electrodes 230A-230H may each be electrically connected to a distal connector (not shown) positioned within the lead extension 110. Each of the proximal electrodes 230A-230H may be electrically connected to a respective wire of the plurality of wiresAttorney Docket No. A0012660W001214A-214H to facilitate delivery of current generated by the IMD 106 to the distal electrodes 224A-224D. In some cases, each of the proximal electrodes 230A-230H may comprise a crimp sleeve or other mechanism that enables the plurality of wires 214A-214H to be respectively connected to the proximal electrodes 230A-230H. For example, each electrode of the proximal electrodes 230A-230H may comprise a crimp sleeve welded thereto that is capable of being further welded to a respective wire to electrically connect the wire to the proximal electrodes 230A-230H. In other cases, one or more of the plurality of wires 214A-214H may be directly connected to the proximal electrodes 230A-320H (e.g., by directly welding the wire to the electrode).

[0085] The plurality of wires 214A-214H may extend distally from the proximal electrodes 230A-230H and be coiled around the stylet lumen 216. The stylet lumen 216 and the coil 212 may extend through the housing 220 toward the distal end 208 of the lead 200. As the stylet lumen 216 and the plurality of wires 214A-214H extend toward the distal end 208, one or more wires of the plurality of wires 214A-214H may be separated off from the coil 212 and connected to a respective distal electrode 224A-224D. In the example depicted in Fig. 2C, the eighth wire 214H may be separated off from the coil 212 and connected to the fourth distal electrode 224D (e.g., the distal electrode furthest from the distal end 208); the fifth wire 214E, the sixth wire 214F, and the seventh wire 214G may be separated off from the coil 212 and connected to three respective portions of the third distal electrode 224C; the second wire 214B, the third wire 214C, and the fourth wire 214D may be separated off from the coil 212 and connected to three respective portions of the second distal electrode 224B, and the first wire 214A may extend past the second distal electrode 224B and connect to the first distal electrode 224A (e.g., the distal electrode closest to the distal end 208). In this example, one or more of the plurality of wires 214A-214H may extend more distally than others (e.g., the first wire 214A extends more distally than the eighth wire 214H).

[0086] In forming the proximal end 204 of the lead 200, the components of the proximal end 204 (e.g., proximal electrodes 230A-230H) may undergo molding and grinding steps, where the proximal electrodes 230A-230H are respectively overmolded with a polymer or other insulative material and ground down to a desired size. The molding and grinding steps may result in the proximal end 204 of the lead having a substantially uniform diameter. In one example, the proximal electrodes 230A-230H may overmolded with a polymer (e.g., poly ether urethane, thermoplastic polyurethanes, or other polymer material). The polymer may help retain the proximal electrodes 230A-230H (e.g., by preventing the proximal electrodes 230A-230H from moving during operation of the lead 200) and / or electrically isolate the proximal electrodes 230A-230H from one another. After molding, the outer surface of the proximal electrodes 230A-Attorney Docket No. A0012660W001230H may be ground down or otherwise removed, such that a diameter of the proximal end 204 is substantially uniform and matches a diameter of the housing 220. In some cases, the lead 200 may comprise a retention sleeve 228 that is overmolded and ground down along with the proximal electrodes 230A-230H to connect the proximal electrodes 230A-230H with the housing 220. In some cases, the distal end 208 of the lead 200 (including the distal electrodes 224A- 224D) may also undergo molding and grinding steps, as discussed in further detail below.

[0087] With reference to Figs. 3A-3C, aspects of an electrode 302 are shown in accordance with at least one embodiment of the present disclosure. The electrode 302 may in some cases be similar to or the same as one of the distal electrodes 224A-224D (e.g., the second distal electrode 224B or the third distal electrode 224C) and / or the electrodes 116, 118. For example, the electrode 302 may comprise a plurality of portions 312A-312C each capable of delivering stimulation signals to and / or detecting response signals from anatomical tissue surrounding the electrode 302.

[0088] The electrode 302 is illustrated to comprise an aperture 304, weld features 308A-308C, and a plurality of edge radii 316. The aperture 304 may provide a multi-dimensional space through which the stylet lumen 216 and / or the coil 212 of the lead 200 can extend when the electrode 302 is connected to the lead 200. The weld features 308A-308C may facilitate electrical connection between the plurality of portions 312A-312C and conductors 340A-340D (e.g., conductor wires such as the plurality of wires 214A-214H). In other words, the weld features 308A-308C may provide locations for each conductor 340A-340D to be welded to the electrode 302. While some views of the accompanying drawings depict some of the weld features 308A- 308C as flat along the main body of the electrode 302, in some cases the weld features 308A- 308C may be raised, angled, proud of, etc. the main body of the electrode 302 to facilitate welding. In one example, a first weld feature 308 A may be used to electrically connect a first conductor 340A to a first portion 312A, a second weld feature 308B may be used to electrically connect a second conductor 340B to a second portion 312B, and a third weld feature 308C may be used to electrically connect a third conductor 340C to the third portion 312C. The edge radii 316 may reduce the current density of the electrode 302 and / or the portions thereof. In one example, the electrode 302 may comprise a first edge radius 316A and a second edge radius 316B positioned between the first weld feature 308 A and the second weld feature 308B on an outer circumference of the electrode 302. The electrode 302 may also comprise four other edge radii: two edge radii positioned between the second weld feature 308B and the third weld feature 308C, and two edge radii positioned between the third weld feature 308C and the first weld feature 308A.The electrode 302 also comprises a plurality of grind features 328A-328C that are removed when the electrode 302 undergoes a grinding step.Attorney Docket No. A0012660W001

[0089] The electrode 302 comprises one or more retention features 320 that facilitate connection between the electrode 302 and the lead 200 during the molding step. During the molding step, the electrode 302 may be overmolded with a polymer 324. The polymer 324 may be or comprise an insulative material (e.g., polyether urethane, thermoplastic polyurethanes, or other polymer material) that electrically isolates the portions 312A-312C from one another and from the conductors 340A-340D. In some cases, the polymer 324 may be distributed onto the electrode 302 such that the aperture 304 of the electrode 302 remains open, enabling the stylet lumen 216 and / or the coil 212 to pass through the aperture 304.

[0090] The one or more retention features 320 may comprise portions that fill with the polymer 324 during the molding step, such that the portions 312A-312C are retained within the polymer 324 after the electrode 302 undergoes the grinding step. In one example, the electrode 302 comprises a concave portion 332 and a concave portion 336 that fill with polymer 324 during the molding step, such that after the grind features 328A-328C have been removed, each of the portions 312A-312C is held in place. In the example shown in Fig. 3C, the portions 312A-312C are circumferentially-segmented from one another, with polymer 324 positioned between each portion to electrically isolate the portions. Each of the portions 312A-312C may comprise the concave portions 332, 336, such that each portion 312A-312C is retained relative to the other components of the lead 200 after the electrode 302 is overmolded and ground down.

[0091] Once the electrode 302 has been overmolded and ground down, one or more wires of the plurality of wires 214A-214H may be electrically connected to the portions 312A-312C. In the example depicted in Fig. 3C, four conductors (e.g., wires) may extend through the aperture 304: the first conductor 340A, the second conductor 340B, the third conductor 340C, and the fourth conductor 340D. In one embodiment, each of the conductors 340A-340D may be similar to or the same as the wires 214A-214D. In the Fig. 3C example, the fourth conductor 340D may be electrically connected to the first portion 312A, the third conductor 340C may be electrically connected to the second portion 312B, the second conductor 340B may be electrically connected to the first portion 312A, and the first conductor 340A may extend past the electrode 302 to electrically connect to a separate, different electrode positioned distal to the electrode 302.

[0092] With reference to Figs. 4A-4D, aspects of an electrode 402 are shown in accordance with at least one embodiment of the present disclosure. In some examples, the electrode 402 may be similar to the electrodes 116, 118, the distal electrodes 224A-224D, and / or the electrode 302. For example, the electrode 402 may provide circumferentially-segmented distal electrodes for delivering or sensing electrical signals.

[0093] The electrode 402 is illustrated to comprise an aperture 404, weld features 408A-408C, and a plurality of edge radii 416. The aperture 404 provides a location through which the styletAttorney Docket No. A0012660W001 lumen 216 and / or the coil 212 of the lead 200 can extend when the electrode 402 is integrated into the lead 200. The weld features 408A-408C may enable the conductors 440A-440C to connect to the portions 412A-412C of the electrode 402. In some examples, the weld features 408A-408C may be raised, angled, proud of, etc. the main body of the electrode 402 to facilitate welding. In one example, a first conductor 440A may be electrically connected to a first portion 412A, a second conductor 440B may be electrically connected to a second portion 412B, and a third conductor 440C may be electrically connected to a third portion 412C. The edge radii 416 may reduce the current density of the electrode 402 and / or the portions thereof. As depicted in Fig. 4A, the electrode 402 may comprise a first edge radius 416A and a second edge radius 416B each positioned between the first weld feature 408 A and the second weld feature 408B. The electrode 402 may comprise additional or alternative edge radii, such as two edge radii positioned between the second weld feature 408B and the third weld feature 408C and / or two edge radii positioned between the first weld feature 408A and the third weld feature 408C. The electrode 402 may also comprise a plurality of grind features 428A-428C that are removed after the electrode 402 undergoes grinding.

[0094] The electrode 402 comprises one or more retention features 420 that facilitate connection between the electrode 402 and the lead 200. During a molding step, the electrode 402 may be overmolded with a polymer 424 (which may be similar to or the same as the polymer 324). The polymer 424 may electrically isolate the portions 412A-412C from one another and from the conductors 440A-440C. In some cases, the polymer 424 may be dispensed into the electrode 402 while avoiding the aperture 404, such that the stylet lumen 216 and / or the coil 212 can still extend at least partially through the electrode 402 toward the distal end 208 after the electrode 402 has been overmolded and ground down.

[0095] The retention features 420 may couple with the polymer 424 during the molding process to keep the electrode 402 connected to the lead 200 after grinding. In one example, the retention features 420 may comprise a tab 448 and a tab 452 that extend out from the portions 412A-412C to couple with the polymer 424. In some cases, the tabs 448, 452 may result in the thickness of the polymer 424 separating the first portion 412A and the second portion 412B varying along a direction 456. For example and as depicted in Fig. 4D, the polymer 424 may have a first thickness 436 at a location of the tabs 448, 452, and a second, different thickness 444 at a location further away from the aperture 404 (e.g., closer to an outer surface of the electrode 402).

[0096] Additionally or alternatively, the retention features 420 may comprise apertures 432A- 432C that are at least partially filled with the polymer 424 when the electrode 402 is overmolded with the polymer 424. In some examples, the apertures 432A-432C may be positioned betweenAttorney Docket No. A0012660W001 an outer surface and an inner surface of the portions 412A-412C. The apertures 432A-432C may enable the polymer 424 that fills the apertures 432A-432C to keep the portions 412A-412C in place after the electrode 402 has been overmolded and ground down.

[0097] Once the electrode 402 is overmolded and ground down, the conductors 440A-440C may be electrically connected to the portions 412A-412C. In one example, the first conductor 440 A may be electrically connected to the first portion 412A, the second conductor 440B may be electrically connected to the second portion 412B, and the third conductor 440C may be electrically connected to the third portion 412C.

[0098] With reference to Figs. 5A-5D, aspects of an electrode 502 in accordance with at least one embodiment of the present disclosure are shown. The electrode 502 may in some cases be similar to or the same as the electrodes 116, 118, the distal electrodes 224A-224D, the electrode 302, and / or the electrode 402. For example, the electrode 502 may comprise circumferentially- segmented distal electrodes for delivering stimulation signals and / or sensing stimulation signals.

[0099] The electrode 502 is illustrated to comprise an aperture 504, weld features 508A-508C, and a plurality of edge radii 516. The aperture 504 provides a section through which the stylet lumen 216 and / or the coil 212 of the lead 200 can extend to electrically connect the electrode 502 to one or more wires of the coil 212. The weld features 508A-508C may enable the conductors 540A-540C to connect to the portions 512A-512C of the electrode 502. In some cases, the weld features 508A-508C may be raised, angled, proud of, etc. relative to the main body of the electrode 502 to facilitate welding. In one example, a first conductor 540A may be electrically connected to a first portion 512A, a second conductor 540B may be electrically connected to a second portion 512B, and a third conductor 540C may be electrically connected to a third portion 512C. The edge radii 516 may reduce the current density of the electrode 502 and / or the portions thereof. As depicted in Fig. 5 A, the electrode 502 may comprise a first edge radius 516A and a second edge radius 516B each positioned between the first weld feature 508A and the second weld feature 508B. The electrode 502 may also comprise four other edge radii: two edge radii positioned between the second weld feature 508B and the third weld feature 508C, and two edge radii positioned between the third weld feature 508C and the first weld feature 508A. The electrode 502 may comprise a plurality of grind features 528A-528C that are removed after the electrode 502 undergoes grinding.

[0100] The electrode 502 comprises one or more retention features 520 that keep one or more portions 512A-512C of the electrode 502 secure relative to the lead 200 such that the portions 512A-512C do not separate from the lead 200. During a molding step, the electrode 502 may be overmolded with a polymer 524 (which may be similar to or the same as the polymer 324 and / orAttorney Docket No. A0012660W001 the polymer 424). In some cases, the aperture 504 of the electrode 502 may not receive polymer 524 and may thus remain open.

[0101] The retention features 520 may attach to one or more portions of the polymer 524 during the molding process, such that the polymer 524 restricts the movement of the electrode 502 and / or portions thereof after the electrode 502 has been ground down. In one example, the electrode 502 comprises a ledge 544 and a ledge 548 that extend partially into the polymer 524 and toward one another. The ledges 544, 548 may cause displacement of the polymer 524 during the overmolding process, such that the thickness of the polymer 524 varies along a direction 552. For example and as depicted in Fig. 5D, the polymer 524 may have a first thickness 532 at a location of the ledges 544, 548, and a second thickness 536 different from the first thickness 532 (e.g., a greater thickness) at a location further way from the aperture 504 (e.g., closer to an outer surface of the electrode 502).

[0102] Fig. 6 is a block diagram of an example IMD 606 for delivering DBS therapy. In some cases, the IMD 606 may be similar to or the same as the IMD 106. In the example shown in Fig. 6, the IMD 606 includes processing circuitry 610, a memory 612, the stimulation generation circuitry 602, sensing circuitry 604, telemetry circuitry 608, and a power source 622. Each of these circuits may be or include electrical circuitry configured to perform the functions attributed to each respective circuit. The memory 612 may include any volatile or non-volatile media, such as a random-access memory (RAM), read only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, any memory discussed herein, and / or the like. The memory 612 may store computer-readable instructions that, when executed by the processing circuitry 610, cause the IMD 606 to perform various functions. The memory 612 may be a storage device or other non-transitory medium. In some examples, the IMD 606 may include or may be referred to as a signal generator.

[0103] The stimulation generation circuitry 602, under the control of the processing circuitry 610, generates stimulation signals (e.g., electrical stimulation signals for evoking ERNA signals and / or therapeutic electrical stimulation signals for delivering therapy such as DBS) for delivery to the patient 112 via electrodes 616, 618 (which may be similar to or the same as the electrodes 116, 118, respectively). An example range of electrical parameters believed to be effective in DBS to manage a movement disorder of patient include: a pulse rate (or frequency) between approximately 5 Hertz (Hz) and approximately 500Hz, such as between approximately 5 to 220Hz or such as approximately 130Hz; in examples with a voltage controlled system, a voltage amplitude between approximately 0.1 volts (V) and approximately 50V, such as between approximately 2V and approximately 3 V; in examples with a current controlled system, a current amplitude between approximately 0.1 milliamps (mA) and approximately 3.5mA, such asAttorney Docket No. A0012660W001 between approximately 1.0mA and approximately 1.75mA; and / or a pulse width between approximately 20 microseconds (ps) and approximately 500ps, such as between approximately 50ps and approximately 200ps. Other ranges of therapy parameter values may also be useful, and may depend on the target stimulation site within patient 112. While stimulation pulses are described, stimulation signals may be of any form, such as continuous-time signals (e.g., sine waves) or the like. In addition to delivering therapeutic electrical stimulation signals, stimulation generation circuitry 602 may be configured to deliver electrical stimulation signals for evoking ERNA signals (e.g., where information indicative of the ERNA signals are stored). Example parameters of the electrical stimulation signals for evoking ERNA signals include amplitude within range of 0 to 7.5mA, such as 0 to 5mA, frequency within range of 5 to 250Hz, such as 80 to 220Hz, and pulse width in range of 20 to 450ps, such as 60 to 120ps.

[0104] The processing circuitry 610 may include fixed function processing circuitry and / or programmable processing circuitry, and may comprise, for example, any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to the processing circuitry 610 herein may be embodied as firmware, hardware, software or any combination thereof. The processing circuitry 610 may control the stimulation generation circuitry 602 according to therapy programs stored in the memory 612 to apply particular parameter values specified by one or more of programs, such as voltage amplitude or current amplitude, pulse width, and / or pulse rate.

[0105] The sensing circuitry 604 is configured to monitor signals from any combination of the electrodes 616, 618. Although the sensing circuitry 604 is incorporated into a common housing with the stimulation generation circuitry 602 and the processing circuitry 610 in Fig. 6, in other examples, the sensing circuitry 604 may be in a separate housing from the IMD 606 and may communicate with the processing circuitry 610 via wired or wireless communication techniques.

[0106] In some examples, the sensing circuitry 604 includes one or more amplifiers, filters, and analog-to-digital converters. The sensing circuitry 604 may be used to sense physiological signals, such as ERNA signals. In some examples, sensing circuitry 604 measures ERNA signals from a particular combination of the electrodes 616, 618. In some cases, the particular combination of electrodes for sensing includes different electrodes than a set of electrodes 616, 618 used to deliver electrical stimulation signals (e.g., therapeutic electrical stimulation signals or electrical stimulation signals for evoking ERNA signals). Alternatively, in other cases, the particular combination of electrodes used for sensing includes at least one of the same electrodes as a set of electrodes used to deliver stimulation signals to the patient 112. The sensing circuitryAttorney Docket No. A0012660W001604 may provide signals to an analog-to-digital converter, for conversion into a digital signal for processing, analysis, storage, or output by the processing circuitry 610.

[0107] The electrodes 616, 618 on the respective leads 614A, 614B (which may be similar to or the same as the leads 114A, 114B, respectively) may be constructed of a variety of different designs. For example, one or both of the leads 614 may include two or more electrodes at each longitudinal location along the length of the lead, such as multiple electrodes (e.g., the portions 312A-312C, the portions 412A-412C, and / or the portions 512A-512C arranged as segments, at different perimeter locations around the perimeter of the lead at each of the locations).

[0108] As an example, one or both of the leads 614 may include both circumferentially- segmented DBS arrays of electrodes and non-segmented electrodes (e.g., ring electrodes). As one example, there may be a first ring electrode of the electrodes 616 around the perimeter of the lead 614A at a first longitudinal location on the lead 614A (e.g., location A). Below the first ring electrode, there may be three segmented electrodes of the electrodes 616 around the perimeter of lead 614A at a second longitudinal location on the lead 614A (e.g., location B). Below the three segmented electrodes, there may be another set of three segmented electrodes of the electrodes 616 around the perimeter of the lead 614A at a third longitudinal location of the lead 614A (e.g., location C). Below the three segmented electrodes, there may be a second ring electrode of the electrodes 616 around the perimeter of the lead 614A (e.g., location D). The electrodes 618 may be similarly positioned along the lead 614B.

[0109] The above is one example of the array of electrodes, and the example techniques should not be considered limited to such an example. There may be other configurations of electrodes for DBS. Moreover, the example techniques are not limited to DBS, and other electrode configurations are possible.

[0110] The telemetry circuitry 608 supports wireless communication between the IMD 606 and the programmer 104 or another computing device under the control of the processing circuitry 610. The processing circuitry 610 of the IMD 606 may receive, as updates to programs, values for various parameters such as magnitude and electrode combination, from the programmer 104 via the telemetry circuitry 608. The telemetry circuitry 608 in the IMD 606, as well as telemetry modules in other devices and systems described herein, such as the programmer 104, may accomplish communication by radiofrequency (RF) communication techniques. In addition, the telemetry circuitry 608 may communicate with an external medical device programmer via proximal inductive interaction of the IMD 106 with the programmer 104. Accordingly, the telemetry circuitry 608 may send information to the programmer 104 on a continuous basis, at periodic intervals, or upon request from the IMD 606 or the programmer 104.Attorney Docket No. A0012660W001

[0111] The power source 622 delivers operating power to various components of the IMD 606. The power source 622 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 the IMD 606. In some examples, power requirements may be small enough to allow IMD 606 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.

[0112] The DBS therapy is defined by one or more therapy programs having one or more parameters stored within the memory 612. For example, the one or more parameters include a current amplitude (for a current-controlled system) or a voltage amplitude (for a voltage- controlled system), a pulse rate or frequency, and a pulse width, or a number of pulses per cycle. In examples where the electrical stimulation is delivered according to a “burst” of pulses, or a series of electrical pulses defined by an “on-time” and an “off-time,” the one or more parameters may further define one or more of a number of pulses per burst, an on-time, and an off-time. The processing circuitry 610, via the electrodes 616, 618, delivers DBS to the patient 112 and may adjust one or more parameters defining the electrical stimulation.

[0113] Fig. 7 is a block diagram of an example programmer 704. In some cases, the programmer 704 may be similar to or the same as the programmer 104. Although the programmer 704 may generally be described as a hand-held device, the programmer 704 may be a larger portable device or a more stationary device. In addition, in other examples, the programmer 704 may be included as part of an external charging device or include the functionality of an external charging device. As illustrated in Fig. 7, the programmer 704 may include processing circuitry 710, a memory 712, a user interface 702, telemetry circuitry 708, and a power source 722.

[0114] The memory 712 may store instructions that, when executed by the processing circuitry 710, cause or enable the processing circuitry 710 and the programmer 704 to provide the functionality ascribed to the programmer 704 throughout this disclosure. Each of these components, or modules, may include electrical circuitry that is configured to perform some or all of the functionality described herein. For example, the processing circuitry 710 may include processing circuitry configured to perform the processes discussed with respect to the processing circuitry 610 of the IMD 606 as described with reference to Fig. 6. In some examples, the programmer 704 may include or may be referred to as a signal generator (e.g., in combination with or separate from the IMD 606).Attorney Docket No. A0012660W001

[0115] In general, the programmer 704 comprises any suitable arrangement of hardware, alone or in combination with software and / or firmware, to perform the techniques attributed to the programmer 704, and the processing circuitry 710, the user interface 702, and the telemetry circuitry 708 of the programmer 704. In various examples, the programmer 704 may include one or more processors, which may include fixed function processing circuitry and / or programmable processing circuitry, as formed by, for example, one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. The programmer 704 also, in various examples, may include the memory 712, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Moreover, although the processing circuitry 710 and the telemetry circuitry 708 are described as separate modules, in some examples, the processing circuitry 710 and the telemetry circuitry 708 may be functionally integrated with one another. In some examples, the processing circuitry 710 and the telemetry circuitry 708 correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units. The memory 712 (e.g., a storage device) may store instructions or data that, when executed by the processing circuitry 710, cause or enable the processing circuitry 710 and the programmer 704 to provide the functionality ascribed to the programmer 704 throughout this disclosure. For example, the memory 712 may include instructions that cause the processing circuitry 710 to obtain a parameter set from memory or receive a user input and send a corresponding command to the IMD 606, or instructions for any other functionality.

[0116] The user interface 702 may be or comprise a keyboard, button, keypad, mouse, trackball, monitor, television, screen, touchscreen, lights, speaker for voice commands, display (e.g., a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED)) and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 702 may be configured to display any information related to the delivery of stimulation therapy, identified patient behaviors, sensed patient parameter values, patient behavior criteria, or any other such information. The user interface 702 may also receive user input via the user interface 702. The input may be, for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen.

[0117] In some cases, the user interface 702 may be useful to allow a physician, patient, or other user to modify instructions to be executed by the processing circuitry 710 according to one or more embodiments of the present disclosure, and / or to modify or adjust a setting of other information displayed on the user interface 702 or corresponding thereto. Although the userAttorney Docket No. A0012660W001 interface 702 is shown as part of the programmer 704, in some examples, the user interface 702 may be housed separately from one or more remaining components of the programmer 704.

[0118] The telemetry circuitry 708 may support wireless communication between the IMD 606 and the programmer 704 under the control of the processing circuitry 710. The telemetry circuitry 708 may also be configured to communicate with another computing device via wireless communication techniques, or direct communication through a wired connection. In some examples, the telemetry circuitry 708 provides wireless communication via an RF or proximal inductive medium. In some examples, the telemetry circuitry 708 includes an antenna, which may take on a variety of forms, such as an internal or external antenna. Examples of local wireless communication techniques that may be employed to facilitate communication between the programmer 704 and the IMD 606 include RF communication according to the 802.11 or Bluetooth specification sets or other standard or proprietary telemetry protocols. In this manner, other external devices may be capable of communicating with the programmer 704 without needing to establish a secure wireless connection.

[0119] In some examples, processing circuitry 710 of the programmer 704 defines the parameters of electrical stimulation therapy, stored in the memory 712, for delivering DBS to the patient 112. In one example, the processing circuitry 710 of the programmer 704, via the telemetry circuitry 708, issues commands to the IMD 606 causing the IMD 606 to deliver electrical stimulation therapy via the electrodes 616, 618 via the leads 614. In one or more examples, the programmer 704 may be configured to perform one or more of the example techniques described in this disclosure. For instance, the processing circuitry 710 may be configured to perform one or more of the example operations described above with respect to the processing circuitry 610. For example, the processing circuitry 710 may be configured to cause the stimulation generation circuitry 602 to deliver a first set of one or more therapeutic electrical stimulation signals according to a first set of one or more parameters.

[0120] Fig. 8 depicts a method 800 that may be used, for example, to manufacture a circumferentially-segmented electrode. It is to be understood that, while the method 800 below specifies three different steps, embodiments of the method 800 may comprise more or fewer steps than those described below, and / or one or more steps that are different than the steps described below.

[0121] The method 800 also comprises electrically connecting an electrode to one or more conductor wires (step 804). The conductor wires (e.g., plurality of wires 214A-214H, conductors 340A-340D, conductors 440A-440C, conductors 540A-540C) may be wound in a coil (e.g., coil 212) around a stylet lumen (e.g., stylet lumen 216) and extend toward the electrode (e.g., the distal electrodes 224A-224D, the electrode 302, the electrode 402, and / or the electrode 502). TheAttorney Docket No. A0012660W001 conductor wires may then be separated from the coil and electrically connected (e.g., welded) to one or more portions of the electrode. In one example, the portions of the electrode may comprise three portions that are electrically isolated from one another after a polymer is dispensed and the electrode is ground down, such that a first conductor wire is electrically connected to a first portion of the electrode, a second conductor wire is electrically connected to a second portion of the electrode, and a third conductor wire is electrically connected to a third portion of the electrode. In some examples, one or more conductor wires not connected to the electrode may extend through the electrode toward the distal end of the lead (e.g., to electrically connect to other electrodes positioned more distally than the electrode).

[0122] The method 800 comprises dispensing a polymer into one or more portions of the electrode to overmold the electrode (step 808). The polymer may be similar to or the same as the polymer 324, the polymer 424, and / or the polymer 524. The electrode may comprise one or more retention features (e.g., retention features 320, retention features 420, retention features 520, etc.) that couple with or connect to the polymer when the polymer is dispensed into, around, inside, etc. the electrode.

[0123] The method 800 also comprises grinding at least one portion of the electrode (step 812). After the electrode has been molded, an outer surface of the electrode may be ground down. The at least one portion of the electrode may be similar to or the same as the grind features 328A- 328C, the grind features 428A-428C, and / or the grind features 528A-528C. The portions of the electrode may be removed such that the outer surface of the electrode substantially aligns with an outer surface of the lead (e.g., lead 200) to which the electrode is attached. In some examples, the one or more retention features of the electrode may retain the portions of the electrode relative to the lead after grinding. After grinding, the electrode may comprise a plurality of portions that are electrically isolated from one another by the polymer. The electrode may be subsequently used in a DBS therapy or other therapy (e.g., by implanting the lead into a surgical site and providing stimulation signals to the surgical site via the electrode portions).

[0124] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are herebyAttorney Docket No. A0012660W001 incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0125] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0126] A set of example statements is provided below:

[0127] Statement 1 : A device, comprising: a distal end (208); a proximal end (204); an electrode (302, 402, 502) positioned between the distal end (208) and the proximal end (204), the electrode comprising (302, 402, 502): a first portion (312A, 412A, 512A) and a second portion (312B, 412B, 512B) segmented from the first portion (312A, 412A, 512A), the first portion (312A, 412A, 512A) comprising at least one retention feature (320, 420, 520); an insulative material (324, 424, 524) positioned between the first portion and the second portion (312B, 412B, 512B) to electrically isolate the first portion (312A, 412A, 512A) from the second portion (312B, 412B, 512B); and an aperture (304, 404, 504) extending through the electrode (302, 402, 502); and a plurality of wires (214A-214H) extending through at least a portion of the aperture (304, 404, 504), wherein a first wire of the plurality of wires (214A-214H) is electrically connected to the first portion (312A, 412A, 512A), and wherein a second wire of the plurality of wires (214A-214H) is electrically connected to the second portion (312B, 412B, 512B).

[0128] Statement 2: The device of Statement 1, wherein the second portion (312B, 412B, 512B) is circumferentially segmented from the first portion (312A, 412A, 512A).

[0129] Statement 3: The device of any of Statements 1-2, wherein the at least one retention feature (320, 420, 520) comprises a concave portion (332, 336) that is at least partially filled by the insulative material (324, 424, 524).

[0130] Statement 4: The device of any of Statements 1-3, wherein the plurality of wires (214A- 214H) is coiled.

[0131] Statement 5: The device of any of Statements 1-4, wherein the at least one retention feature (320, 420, 520) comprises an aperture (432A-432C) that is at least partially filled by the insulative material (324, 424, 524).Attorney Docket No. A0012660W001

[0132] Statement 6: The device of any of Statements 1-5, wherein a thickness of the insulative material (324, 424, 524) positioned between the first portion (312A, 412A, 512A) and the second portion (312B, 412B, 512B) varies along a first direction.

[0133] Statement 7: The device of any of Statements 1-6, wherein the insulative material (324, 424, 524) comprises polyether urethane.

[0134] Statement 8: The device of any of Statements 1-7, wherein the electrode (302, 402, 502) further comprises a third portion (312C, 412C, 512C) that is electrically isolated from the first portion (312A, 412A, 512A) and from the second portion (312B, 412B, 512B) by the insulative material (324, 424, 524).

[0135] Statement 9: The device of Statement 8, wherein the first portion (312A, 412A, 512A) and the third portion (312C, 412C, 512C) each comprises a concave portion (332, 336) that is filled by the insulative material (324, 424, 524).

[0136] Statement 10: The device of any of Statements 8-9, wherein the third portion (312C, 412C, 512C) is circumferentially segmented from the first portion (312A, 412A, 512A) and from the second portion (312B, 412B, 512B).

[0137] Statement 11 : The device of any of Statements 8-10, wherein a third wire of the plurality of wires (214A-214H) is electrically connected to the third portion (312C, 412C, 512C).

[0138] Statement 12: The device of any of Statements 1-11, wherein at least one wire of the plurality of wires (214A-214H) extends beyond the electrode (302, 402, 502) and toward the distal end (208).

[0139] Statement 13: A lead, comprising: a distal end (208); a proximal end (204); an electrode (302, 402, 502) positioned between the distal end (208) and the proximal end (204), the electrode (302, 402, 502) comprising: a first portion (312A, 412A, 512A) and a second portion (312B, 412B, 512B) segmented from the first portion (312A, 412A, 512A), the first portion (312A, 412A, 512A) comprising a retention feature (320, 420, 520); an insulative material (324, 424, 524) positioned between the first portion (312A, 412A, 512A) and the second portion (312B, 412B, 512B) to electrically isolate the first portion (312A, 412A, 512A) from the second portion (312B, 412B, 512B), wherein the insulative material (324, 424, 524) couples with the retention feature (320, 420, 520); and an aperture (304, 404, 504) extending through the electrode (302, 402, 502); and a plurality of wires (214A-214H) extending through at least a portion of the aperture (304, 404, 504), wherein a first wire of the plurality of wires (214A-214H) is electrically connected to the first portion (312A, 412A, 512A), and wherein a second wire of the plurality of wires (214A-214H) is electrically connected to the second portion (312B, 412B, 512B).

[0140] Statement 14: The lead of Statement 13, wherein the second portion (312B, 412B, 512B) is circumferentially segmented from the first portion (312A, 412A, 512A).Attorney Docket No. A0012660W001

[0141] Statement 15: The lead of any of Statements 13-14, wherein the retention feature (320, 420, 520) comprises a concave portion (332, 336) that is at least partially filled by the insulative material (324, 424, 524).

[0142] Statement 16: The lead of any of Statements 13-15, wherein the plurality of wires (214A-214H) is coiled.

[0143] Statement 17: The lead of any of Statements 13-16, wherein the retention feature (320, 420, 520) comprises an aperture (432A-432C), and wherein the insulative material (324, 424, 524) is at least partially positioned within the aperture (432A-432C).

[0144] Statement 18: The lead of any of Statements 13-17, wherein a thickness of the insulative material (324, 424, 524) positioned between the first portion (312A, 412A, 512A) and the second portion (312B, 412B, 512B) varies along a first direction.

[0145] Statement 19: An implantable lead, comprising: a distal end (208); a proximal end (204); an electrode (302, 402, 502) positioned between the distal end (208) and the proximal end (204), the electrode (302, 402, 502) comprising: a first portion (312A, 412A, 512A), a second portion (312B, 412B, 512B), and a third portion (312C, 412C, 512C) segmented from the first portion (312A, 412A, 512A) and from the second portion (312B, 412B, 512B), the third portion (312C, 412C, 512C) comprising a retention feature (320, 420, 520); an insulative material (324, 424, 524) that electrically isolates the third portion (312C, 412C, 512C) from the first portion (312A, 412A, 512A) and from the second portion (312B, 412B, 512B), wherein the insulative material (324, 424, 524) couples with the retention feature (320, 420, 520); and an aperture (304, 404, 504) extending through the electrode (302, 402, 502); and a plurality of wires (214A-214H) extending through at least a portion of the aperture (304, 404, 504), wherein a first wire of the plurality of wires (214A-214H) is electrically connected to the first portion (312A, 412A, 512A), and wherein a second wire of the plurality of wires (214A-214H) is electrically connected to the second portion (312B, 412B, 512B).

[0146] Statement 20: The implantable lead of Statement 19, wherein a thickness of the insulative material (324, 424, 524) positioned between the first portion (312A, 412A, 512A) and the third portion (312C, 412C, 512C) varies along a first direction.

Claims

Attorney Docket No. A0012660W001CLAIMSWhat is claimed is:

1. A device, comprising: a distal end (208); a proximal end (204); an electrode (302, 402, 502) positioned between the distal end (208) and the proximal end (204), the electrode (302, 402, 502) comprising: a first portion (312 A, 412A, 512A) and a second portion (312B, 412B, 512B) segmented from the first portion (312A, 412A, 512A), the first portion (312A, 412A, 512A) comprising at least one retention feature (320, 420, 520); an insulative material (324, 424, 524) positioned between the first portion and the second portion (312B, 412B, 512B) to electrically isolate the first portion (312A, 412A, 512A) from the second portion (312B, 412B, 512B); and an aperture (304, 404, 504) extending through the electrode (302, 402, 502); and a plurality of wires (214A-214H) extending through at least a portion of the aperture (304, 404, 504), wherein a first wire of the plurality of wires (214A-214H) is electrically connected to the first portion (312A, 412A, 512A), and wherein a second wire of the plurality of wires (214A-214H) is electrically connected to the second portion (312B, 412B, 512B).

2. The device of claim 1, wherein the second portion (312B, 412B, 512B) is circumferentially segmented from the first portion (312A, 412A, 512A).

3. The device of any of claims 1-2, wherein the at least one retention feature (320, 420, 520) comprises a concave portion (332, 336) that is at least partially filled by the insulative material (324, 424, 524).

4. The device of any of claims 1-3, wherein the plurality of wires (214A-214H) is coiled.

5. The device of any of claims 1-4, wherein the at least one retention feature (320, 420, 520) comprises an aperture (432A-432C) that is at least partially filled by the insulative material (324, 424, 524).Attorney Docket No. A0012660W0016. The device of any of claims 1-5, wherein a thickness of the insulative material (324, 424, 524) positioned between the first portion (312A, 412A, 512A) and the second portion (312B, 412B, 512B) varies along a first direction.

7. The device of any of claims 1-6, wherein the insulative material (324, 424, 524) comprises polyether urethane.

8. The device of any of claims 1-7, wherein the electrode (302, 402, 502) further comprises a third portion (312C, 412C, 512C) that is electrically isolated from the first portion (312A, 412A, 512A) and from the second portion (312B, 412B, 512B) by the insulative material (324, 424, 524).

9. The device of claim 8, wherein the first portion (312A, 412A, 512A) and the third portion (312C, 412C, 512C) each comprises a concave portion (332, 336) that is filled by the insulative material (324, 424, 524).

10. The device of any of claims 8-9, wherein the third portion (312C, 412C, 512C) is circumferentially segmented from the first portion (312A, 412A, 512A) and from the second portion (312B, 412B, 512B).

11. The device of any of claims 8-10, wherein a third wire of the plurality of wires (214A-214H) is electrically connected to the third portion (312C, 412C, 512C).

12. The device of any of claims 1-11, wherein at least one wire of the plurality of wires (214A-214H) extends beyond the electrode (302, 402, 502) and toward the distal end (208).

13. A lead, comprising: a distal end (208); a proximal end (204); an electrode (302, 402, 502) positioned between the distal end (208) and the proximal end (204), the electrode (302, 402, 502) comprising: a first portion (312 A, 412A, 512A) and a second portion (312B, 412B, 512B) segmented from the first portion (312A, 412A, 512A), the first portion (312A, 412A, 512A) comprising a retention feature (320, 420, 520);Attorney Docket No. A0012660W001 an insulative material (324, 424, 524) positioned between the first portion (312A, 412A, 512A) and the second portion (312B, 412B, 512B) to electrically isolate the first portion (312A, 412A, 512A) from the second portion (312B, 412B, 512B), wherein the insulative material (324, 424, 524) couples with the retention feature (320, 420, 520); and an aperture (304, 404, 504) extending through the electrode (302, 402, 502); and a plurality of wires (214A-214H) extending through at least a portion of the aperture (304, 404, 504), wherein a first wire of the plurality of wires (214A-214H) is electrically connected to the first portion (312A, 412A, 512A), and wherein a second wire of the plurality of wires (214A-214H) is electrically connected to the second portion (312B, 412B, 512B).

14. The lead of claim 13, wherein the second portion (312B, 412B, 512B) is circumferentially segmented from the first portion (312A, 412A, 512A).

15. The lead of any of claims 13-14, wherein the retention feature (320, 420, 520) comprises a concave portion (332, 336) that is at least partially filled by the insulative material (324, 424, 524)..

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