Methods and systems for manufacturing a lead having segmented electrodes

Abstract

Described herein are methods of manufacturing a lead, comprising inserting a plurality of segmented electrodes into a respective plurality of segmented electrode carrying cavities of a non-conductive tubular body, wherein a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities is defined by a pair of tabs of a plurality of tabs protruding from an inner wall of the tubular body such that an inner surface of a segmented electrode of the plurality of segmented electrodes is exposed.

Description

Attorney Docket No: 78895-20048.40METHODS AND SYSTEMS FOR MANUFACTURING A LEAD HAVING SEGMENTED ELECTRODES CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 788,632, filed April 14, 2025, the contents of which are incorporated herein in its entirety.FIELD

[0002] This disclosure relates generally to systems and methods for manufacturing leads, and, more specifically to systems and methods for manufacturing stimulation and / or sensing leads having segmented electrodes.BACKGROUND

[0003] Deep brain stimulation (DBS) is a neurostimulation therapy that can be used to treat neurodegenerative disorders such as epilepsy and Parkinson’s disease (PD). In DBS, an artificial electrical current is provided to specific parts of the brain to stimulate neurons, which in turn eases the symptoms experienced in different brain conditions. For example, in patients with PD, high-frequency stimulation is provided to regions of the basal ganglia (e.g., the subthalamic nucleus (STN) or internal globus pallidus (GPi)) to correct imbalances in excitation-inhibition in the basal ganglia circuit. DBS can ease motor symptoms experienced in PD and decrease the need for pharmacological treatment.

[0004] Deep brain stimulation systems, otherwise referred to herein as neurostimulation systems, commonly include a pulse generator and one or more leads including electrode(s) that are implanted in the brain. The pulse generator can be implanted in the upper chest of the patient or can be cranially mounted to the head of the patient, proximate to the lead implantation site. Neuromodulation leads often include an arrangement of both cylindrical (i.e., ring) electrodes and segmented electrodes at a distal portion of the neuromodulation lead. The segmented electrodes enable current steering in stimulating or sensing characteristics at the intended site in the brain.

[0005] Given the diameter of the neuromodulation lead and the size of the intended stimulation site, the electrodes on the lead must be small. The segmented electrodes, which can be more than a third of the size smaller than the ring electrodes, must be especially small. These size limitations, and in particular, the size limitations of the segmented electrodes, introduce challenges in manufacturing the electrodes and in manufacturing a lead with said1MF-368639102Attorney Docket No: 78895-20048.40electrodes. Moreover, several design requirements for the electrodes exist to ensure a properly functioning neuromodulation lead. For example, the surface area of the electrode can impact patient safety, clinical utility of the device, and performance of the lead. To ensure patient safety, the electrodes must be biocompatible, manufactured without sharp edges, and must adhere to the lead throughout the lifetime of the lead.SUMMARY

[0006] Described herein are various methods and systems for manufacturing stimulation and / or sensing leads having segmented electrodes, referred to hereinafter collectively as leads for simplicity. Some methods disclosed herein include the use of a non-conductive polymer carrier or a polymer overmold that retains the segmented electrodes so that the segmented electrodes can be easily attached to the elongated core of the lead. The carrier or overmold can be used with already separated segmented electrodes or with a pre-electrode, the inner diameter of which can be machined to form segmented electrodes. Once attached to the core, the carrier or overmold can be machined away, leaving behind the segmented electrodes on the lead. Another method includes the use of a pre-electrode and a polymer that is deposited between gaps of the pre-electrode, forming polymer tabs that keep the segmented electrode portions of the pre-electrode separated. When the inner diameter of the pre-electrode is machined away, the polymer retains the segmented electrode array in a ring shape for attaching to the elongated core of the lead. Other methods disclosed herein include the use of a non-conductive, cylindrical frame that includes arms for retaining the segmented electrodes in the frame. At least a portion of the cylindrical frame retaining the segmented electrodes can be left in place with the segmented electrodes when it is attached to the elongated core of the lead because it is non-conductive. The various manufacturing methods and systems disclosed herein can greatly simplify existing manufacturing methods of segmented electrodes, known to be challenging to manufacture due to their size, fragility, and necessary design specifications that ensure proper functioning and performance.

[0007] In some aspects, a method of manufacturing a lead is provided, comprising: inserting a plurality of segmented electrodes into a respective plurality of segmented electrode carrying cavities of a non-conductive tubular body, wherein a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities is defined by a pair of tabs of a plurality of tabs protruding from an inner wall of the tubular body such that an inner surface of a segmented electrode of the plurality of segmented electrodes is exposed.2MF-368639102Attorney Docket No: 78895-20048.40

[0008] In some aspects, a method of manufacturing a lead is provided, comprising: overmolding a cylindrical pre-electrode with a non-conductive polymer to form a tubular body comprising a plurality of tabs, wherein the tabs fill a plurality of gaps separating a plurality of radially spaced segmented electrode portions of the pre-electrode; and generating a hole through the cylindrical pre-electrode that intersects the tabs to generate a plurality of segmented electrodes retained by the tubular body.

[0009] In some aspects, a method of manufacturing a lead is provided, comprising: depositing a non-conductive polymer into a plurality of gaps of a cylindrical pre-electrode to form a plurality of polymer tabs separating a plurality of radially spaced segmented electrode portions of the cylindrical pre-electrode; and generating a hole through the cylindrical pre-electrode that intersects the plurality of polymer tabs to generate a plurality of segmented electrodes retained by the plurality of polymer tabs.

[0010] In some aspects, a method of manufacturing a lead is provided, comprising: connecting a plurality of segmented electrodes to a respective plurality of segmented electrode carrying openings of a non-conductive cylindrical frame that are defined by a pair of arms extending axially from a ring portion contacting each of the plurality of segmented electrodes, wherein retention features of the ring portion and / or the arms retain the segmented electrodes within the segmented electrode carrying openings.

[0011] In some aspects, an assembly for manufacturing a lead is provided, comprising: a plurality of segmented electrodes; and a non-conductive tubular body comprising: a plurality of tabs protruding from an inner wall of the tubular body; and a plurality of segmented electrode carrying cavities, wherein a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities is defined along the inner wall of the tubular body by a pair of the plurality of tabs, and wherein an inner surface of a segmented electrode of the plurality of segmented electrodes is exposed when the segmented electrode is retained in a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities.

[0012] In some aspects, an assembly for manufacturing a lead is provided, comprising: a cylindrical pre-electrode comprising a plurality of radially spaced segmented electrode portions, a pair of the plurality of segmented electrode portions spaced apart by a gap of a plurality of gaps; and a non-conductive polymer overmolded onto the pre-electrode to form i) a tubular body having a plurality of tabs and / or ii) a plurality of individual tabs, wherein the tabs and / or the individual tabs fill the plurality of gaps to separate the segmented electrodes.

[0013] In some aspects, an assembly for manufacturing a lead is provided, comprising: a plurality of segmented electrodes; and a non-conductive cylindrical frame comprising: a ring 3MF-368639102Attorney Docket No: 78895-20048.40portion that contacts ends of the respective segmented electrodes; a plurality of arms extending axially from the ring portion; and a plurality of segmented electrode carrying openings, a segmented electrode carrying opening of the plurality of segmented electrode carrying openings defined by a pair of the plurality of arms and the ring portion, wherein an arm of the plurality of arms and / or a segmented electrode of the plurality of segmented electrodes comprises a retention feature configured for retaining the segmented electrode within a given segmented electrode carrying opening.BRIEF DESCRIPTION OF THE FIGURES

[0014] Various aspects of the disclosed systems and methods are set forth with particularity in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by reference to the detailed description of illustrative embodiments and the accompanying drawings.

[0015] FIGS. 1A-1C show an exemplary distal portion of a stimulation / sensing lead having ring electrodes and segmented electrodes, in accordance with some embodiments. FIG. 1A shows a partially transparent prospective view of the distal portion of the stimulation / sensing lead, in accordance with some embodiments. FIG. IB shows a side view of the distal portion of the stimulation / sensing lead of FIG. 1A, in accordance with some embodiments. FIG. 1C shows a cross-sectional view of the stimulation / sensing lead of FIG. A along plane C-C in FIG. IB, in accordance with some embodiments.

[0016] FIGS. 2A-2E show an exemplary method of manufacturing a stimulation / sensing lead having segmented electrodes using a segmented electrode carrier, in accordance with some embodiments. FIG. 2A shows exemplary segmented electrodes having conductors joined thereto, in accordance with some embodiments. FIG. 2B shows an exemplary segmented electrode carrier, in accordance with some embodiments. FIG. 2C shows the segmented electrodes of FIG. 2A inserted into the segmented electrode carrier of FIG. 2B, in accordance with some embodiments. FIG. 2D shows the segmented electrode carrier containing electrodes of FIG. 2C disposed on the distal end of an elongated core of a stimulation / sensing lead, in accordance with some embodiments. FIG. 2E shows the segmented electrodes on the distal end of a stimulation / sensing lead after removing the outer portion of the segmented electrode carrier of FIG. 2D, in accordance with some embodiments.4MF-368639102Attorney Docket No: 78895-20048.40

[0017] FIG. 3 shows an exemplary segmented electrode carrier carrying six segmented electrodes that can be used in the method of FIGS.2A-2E, in accordance with some embodiments.

[0018] FIGS. 4A-4C show an exemplary method of manufacturing a stimulation / sensing lead having segmented electrodes by overmolding the segmented electrodes, in accordance with some embodiments. FIG.4A shows an exemplary segmented electrode that has been machined to the desired shape, size, and to include the desired features, in accordance with some embodiments. FIG.4B shows three segmented electrodes held against a core for overmolding the electrodes using pins, in accordance with some embodiments. FIG.4C shows three segmented electrodes overmolded by a polymer material with openings from holding the electrodes on the core with pins, in accordance with some embodiments.

[0019] FIGS. 5A-5D show exemplary segmented electrodes and carriers that can be used for the segmented electrodes and carriers in the methods of FIGS.2A-2E and / or FIGS.4A-4C, in accordance with some embodiments. FIG.5A shows an exemplary segmented electrode having a plurality of notches disposed along lateral edges of the segmented electrode, in accordance with some embodiments. FIG.5B shows an exemplary segmented electrode having a slot disposed along lateral edges of the segmented electrode, in accordance with some embodiments. FIG.5C shows exemplary segmented electrodes having a slot extending the full length of the edge of the segmented electrodes, the tabs of the carrier having corresponding protrusions for receiving the slots, in accordance with some embodiments. FIG.5D shows an exemplary polymer carrier that includes an end wall for retaining segmented electrodes, in accordance with some embodiments.

[0020] FIGS. 6A-6C show an exemplary method of manufacturing a stimulation / sensing lead having segmented electrodes by overmolding a pre-electrode that forms the segmented electrodes, in accordance with some embodiments. FIG.6A shows an exemplary preelectrode for forming the segmented electrodes, in accordance with some embodiments. FIG.6B shows the pre-electrode of FIG.6A overmolded, in accordance with some embodiments.FIG. 6C shows the overmolded pre-electrode of FIG.6B with the inner diameter machined out to form segmented electrodes, in accordance with some embodiments.

[0021] FIGS. 7A-7E show an exemplary method of manufacturing a stimulation / sensing lead having segmented electrodes by depositing a polymer into gaps of a pre-electrode that forms segmented electrodes, in accordance with some embodiments. FIG.7A shows two preelectrodes, each forming three segmented electrodes, having a polymer deposited within the gaps of the pre-electrodes and a spacer between the pre-electrodes, in accordance with some 5MF-368639102Attorney Docket No: 78895-20048.40embodiments. FIG.7B shows a close-up of an end of the pre-electrode shown in FIG.7A, in accordance with some embodiments. FIG.7C shows the two pre-electrodes of FIG.7A having the inner diameter machined out, in accordance with some embodiments. FIG.7D shows the segmented electrode arrays from the two pre-electrodes of FIG.7C disposed on the distal end of an elongated core of a stimulation / sensing lead, in accordance with some embodiments. FIG.7E shows a front view of the distal end of the elongated core having the segmented electrode arrays disposed thereon of FIG.7D, in accordance with some embodiments.

[0022] FIGS. 8A-8B shows an exemplary pre-electrode for forming three segmented electrodes according to the method of FIGS.7A-7E, in accordance with some embodiments.FIG. 8A shows a pre-electrode for forming three segmented electrodes that has polymer deposited in the gaps of the pre-electrode, in accordance with some embodiments. FIG.8B shows the pre-electrode of FIG.8A with the inner diameter machined out, in accordance with some embodiments.

[0023] FIGS. 9A-9D show an exemplary method for manufacturing a stimulation / sensing lead having segmented electrodes by attaching the segmented electrodes to a frame, in accordance with some embodiments. FIG.9A shows attaching segmented electrodes having a slot extending the full length of the edge of the segmented electrode to a frame having corresponding protrusions for receiving the slots, in accordance with some embodiments. FIG. 9B shows attaching segmented electrodes having a slot extending part of the length of the edge of the segmented electrode to a frame having corresponding protrusions for receiving the slots, in accordance with some embodiments. FIG.9C shows a side view of attaching the segmented electrodes and frame of FIG. 9B, in accordance with some embodiments. FIG. 9D shows a heat shrink over a segmented electrode and frame assembly that can be used for the segmented electrode and frame assembly shown in any of FIGS. 9A-9C.

[0024] FIG. 10 shows an exemplary method for manufacturing a stimulation / sensing lead having segmented electrodes by inserting the segmented electrodes into slots of a frame, in accordance with some embodiments.DETAILED DESCRIPTION

[0025] Described herein are various methods of manufacturing stimulation and / or sensing leads having segmented electrodes, and systems for the same. The methods and systems described herein can simplify the manufacturing processes for segmented electrodes, which 6MF-368639102Attorney Docket No: 78895-20048.40are known to be challenging to properly position on and attach to a stimulation and / or sensing lead (referred to hereinafter, with either stimulation or sensing functionality, or both, as a “lead”) due to their small size and shape. For example, the methods and systems described herein can simplify manufacturing processes for leads having segmented electrodes by providing a non-conductive polymer carrier or overmold for retaining segmented electrodes while attaching to the remainder of the lead. The methods and systems described herein can be used for already separated segmented electrodes, or for a pre-electrode, i.e., a monolithic, conductive cylindrical body that can be machined to form segmented electrodes. For example, the methods and systems described herein can include overmolding a pre-electrode or depositing polymer into gaps of the pre-electrode such that, when the inner diameter of the pre-electrode is machined away, polymer tabs formed from the polymer overmold or deposits retains the segmented electrodes in a ring shape for attaching to the rest of the lead. In another system and manufacturing method described herein, segmented electrodes can be inserted into a cylindrical frame including segmented electrode carrying openings defined by a ring portion and one or more arms extending therefrom for retaining the segmented electrodes. Using the methods and systems described herein, leads for directionally stimulating a site that exhibit proper functioning and performance can be provided.

[0026] The following disclosure describes an exemplary stimulation lead that can include the segmented electrodes manufactured from the pre-electrodes described herein. The stimulation lead can also be a sensing lead. Alternatively, a sensing lead can take the form of any stimulation lead described herein to include segmented electrodes manufactured in accordance with the methods described herein. Following the description of the stimulation lead, various methods and systems for manufacturing leads having segmented electrodes are described. First, manufacturing methods and systems that include the use of a polymer carrier or overmold for retaining the segmented electrodes are described. Next, manufacturing methods and systems that include the use of a pre-electrode and overmold or partial polymer deposits for retaining the segmented electrodes once the inner diameter of the pre-electrode is machined away are described. Finally, manufacturing methods and systems that include the use of a cylindrical frame for retaining the segmented electrodes are described.Stimulation / Sensing Leads Having Segmented Electrodes

[0027] FIGS. 1A-1C illustrate an exemplary stimulation lead 100 including segmented electrodes 102 at a distal portion of the lead body 106. The stimulation lead 100 can additionally or alternatively be a sensing lead for sensing at the segmented electrodes 102.7MF-368639102Attorney Docket No: 78895-20048.40The stimulation lead 100 can include one or more ring electrodes 104 in addition to the segmented electrodes 102. For example, the segmented electrodes 102 and ring electrodes 104 can be arranged in a 1 -3-3-1 configuration such that the stimulation includes 8 total electrodes (6 segmented electrodes and 2 ring electrodes). The stimulation lead 100 is not intended to be limited to this configuration and can include any amount of segmented electrodes 102 and / or ring electrodes 104. For example, the stimulation lead 100 can include at least 1, 2, 3, 4, 5, 6 or more segmented electrodes 102. The stimulation lead 100 can include at least 1, 2, 3 or more ring electrodes 104. In some examples, the stimulation lead 100 does not include ring electrodes 104.

[0028] The electrodes, i.e., the segmented electrodes 102 and / or the ring electrodes 104 can be composed of a conductive material. The conductive material can include, for example, platinum-iridium (Pt-Ir), platinum (Pt), gold (Au), stainless steel (e.g., 316L, 316LVM) titanium (Ti), nickel (Ni), and / or alloys thereof (e.g., titanium alloy, nickel alloy, etc.). In some examples, the segmented electrodes 102 and / or the ring electrodes 104 are composed of 90 / 10 Pt-Ir.

[0029] The lead body 106 can include a polymer material, such as thermoplastic polyurethane (e.g., Tecothane 55D, Tecothane 75D), silicone, polyether block amide (PEBA), polycarbonate urethane (PCU)., and / or polysiloxane-polyurethane copolymer. In some examples, the distal tip 107 of the lead body 106 can be composed of a more rigid polymer than the remainder of the body. For example, the lead body 106 can be composed of Tecothane 55D, whereas the distal tip 107 can be composed of Tecothane 75D. In some examples, the distal tip 107 can be an electrode.

[0030] The stimulation lead 100 can include an elongated core 108 within the lead body 106. The stimulation lead can include one or more conductors (e.g., wires, or cables) 110 within the lead body, separated by the elongated core 108. The elongated core 108 can be composed of an insulative material for insulating a plurality of conductors, e.g., at least one for each electrode, from one another. For example, the elongated core 108 can be composed of a fluoropolymer, such as ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxy (PF A), polyvinylidene fluoride (PVDF), fluorinated ethylene propylene (FEP), and / or polyether ether ketone (PEEK). The conductors 110 can be composed of a conductive material, such as one or more of the conductive materials described herein with respect to the segmented electrodes 102 and ring electrodes 104. In some examples, the conductors 110 are composed of platinum-iridium (Pt-Ir), such as 80 / 20 Pt-Ir.8MF-368639102Attorney Docket No: 78895-20048.40

[0031] In some examples, the distal portion of the stimulation lead 100 includes an orientation marker 112 disposed on the lead body 106. The orientation marker 112 can aid in orienting the segmented electrodes 102 during use of the stimulation lead 100. The orientation marker 112 can be ring-shaped. The orientation marker 112 can include one or more cutouts forming thinner rings along the length of the orientation marker 112. For example, as shown in FIG. 1A, the orientation marker 112 can include a single cutout with a ring on either end. The orientation marker 112 can be composed of a radiopaque material so that it can be viewed using various imaging modalities, e.g., X-ray, CT scan. For example, the radiopaque material can include titanium, tungsten, barium sulfate, bismuth oxide, and / or zirconium oxide.

[0032] FIGS. 1B-1C illustrate dimensions of the various components of the stimulation lead 100 described herein. In some examples, the segmented electrodes 102 can have a length 114 of 1-2 mm, such as between 1.2-1.8 mm, or between 1.4-1.6 mm. In some examples, the length 114 of the segmented electrodes 102 is about 1.5 mm.

[0033] In some examples, the length 116 of the ring electrodes 104 is substantially the same as the segmented electrodes 102. For example, the length 116 of the ring electrodes 104 can be between 1-2 mm, 1.2-1.8 mm, or 1.4-1.6 mm. In some examples, the length 116 of the ring electrodes 104 is about 1.5 mm.

[0034] In some examples, a surface area 118 of a segmented electrode 102 is between 1-3 mm2, such as between 1-2.5 mm2, or between 1-2 mm2. In some examples, the surface area 118 of the segmented electrode 102 is about 1.7 mm2.

[0035] In some examples, a surface area 120 of a ring electrode 104 is between 4-8 mm2, such as between 4-7 mm2, 5-7 mm2, or 6-7 mm2. In some examples, the surface area 120 of the ring electrode 104 is about 6.12 mm2.

[0036] In some examples, the electrodes are spaced apart from one another by a distance 122 between 0.25-1 mm, such as between 0.25-0.75 mm, or between 0.25-0.5 mm. The distance 122 can be the distance between a ring electrode 104 and a segmented electrode 102 (as shown in FIG. IB), the distance between two segmented electrodes 102 spaced apart along the longitudinal axis 124 of the stimulation lead 100, the distance between two ring electrodes 104, etc. In some examples, the distance 122 between two electrodes along the longitudinal axis 124 is about 0.5 mm.

[0037] In some examples, a length 126 of the electrode array, i.e., a distance between a distal end of the distal-most electrode and a proximal end of the proximal-most electrode, is9MF-368639102Attorney Docket No: 78895-20048.40between 5-10 mm, such as between 6-9 mm, or between 7-8 mm. In some examples, the length 126 of the electrode array is about 7.5 mm.

[0038] In some examples, a diameter 128 of the lead body 106 is between 1-3 mm, such as between 1-2.5 mm, 1-2 mm, or 1-1.5 mm. In some examples, the diameter 128 of the lead body is about 1.3 mm. The diameter of the ring electrodes 104, and / or of a set of segmented electrodes 102 circumferentially aligned about the lead body 106, may be substantially the same as the diameter 128 of the lead body 106.

[0039] Turning to FIG. 1C, in some examples, an angle 130 of the segmented electrodes 102 can be between 90-110°, such as 92-108°, 95-105°, or 98-102°. In some examples, the angle 130 of the segmented electrodes 102 is about 100°.

[0040] In some examples, the segmented electrodes 102 within a set of segmented electrodes that are circumferentially aligned about the lead body 106 may be spaced apart by a distance 132 of 0.1-0.4 mm, such as 0.2-0.4 mm, or 0.2-0.3 mm. In some examples, the distance 132 between segmented electrodes 102 within a set of segmented electrodes circumferentially aligned about the lead body 106 is about 0.23 mm.Polymer Carriers or Overmold for Segmented Electrodes

[0041] Methods for manufacturing stimulation (and / or sensing) leads having segmented electrodes can include the use of a non-conductive polymer carrier or polymer overmold. FIGS. 2A-2E illustrate a method of manufacturing a lead having segmented electrodes using a segmented electrode carrier 200, in accordance with some embodiments. As shown in FIG.2A, the method can include electrically joining conductors 204a, 204b, 204c (collectively referred to hereinafter as conductor 204) (e.g., a wire) to a segmented electrode 202. The conductor 204 can be attached to the segmented electrode 202 by a weld, such as a resistance weld, laser weld, or other similar connection. In some examples, an inner surface of the segmented electrode 202 can include one or more grooves 206a, 206a’, 206b, 206b’, 206c, 206c’ (collectively referred to hereinafter as grooves 206) for receiving the conductor 204. The method can include forming (i.e., machining) the grooves 206 into the segmented electrode 202. In some examples, the grooves 206 can be formed prior to inserting the segmented electrodes 202 into the carrier 200. The grooves 206 can extend at least part of the length of the segmented electrode 202, and in some examples, can extend the full length of the segmented electrode 202. The grooves 206 can be semi-circular, rectangular, or another shape. The step shown in FIG. 2A can be repeated for each segmented electrode 202 and conductor 204 to be included in the lead.10MF-368639102Attorney Docket No: 78895-20048.40

[0042] FIG. 2B illustrates a segmented electrode carrier 200, in accordance with some embodiments. The carrier 200 can include a tubular body 208 that includes a plurality of (e.g., two or more, such as three, four, etc.) tabs 210a, 210b, 210c (collectively referred to hereinafter as tabs 210) protruding from an inner surface 212 of the tubular body 208 toward a central longitudinal axis 209 of the carrier 200. The tabs 210 can define a plurality of (e.g., two or more, such as three, four, etc.) segmented electrode carrying cavities 214a, 214b, 214c (collectively referred to hereinafter as segmented electrode carrying cavities 214) within the carrier 200. For example, a pair of tabs 210 can define each segmented electrode carrying cavity 214. As shown in FIG.2B, the segmented electrode carrying cavities 214 can be radially aligned with one another within the tubular body 208.

[0043] The carrier 200 can be composed of a non-conductive material. The carrier 200 can be composed of a polymer material. In some examples, the carrier 200 can be composed of a high durometer (e.g., 75 D or higher, such as 75-100 D) elastomer or rigid thermoplastic. For example, the carrier 200 can be composed of silicone, polyurethane, polyetheretherketone (PEEK), polysulfone (PSU), polyphenylsulfone (PPSU), polycarbonate (PC), and / or epoxy resin. In some examples, the carrier 200 can be composed of a compliant (e.g., having a low durometer, such as less than 55 D, e.g. 30-55 D) material, such as silicone (PDMS), polyurethane (PU) elastomers, latex or synthetic rubber, thermoplastic elastomers (TPEs), and / or polyvinyl chloride (PVC).

[0044] The tabs 210 can be sized and shaped such that the carrier 200 can retain the segmented electrodes 202 therein. For example, as shown in FIG.2A, the edges of the segmented electrode 202 can be angled such that the inner surface of the segmented electrode 202 is smaller than the outer surface of the segmented electrode 202. The tabs 210 can be acutely angled accordingly to retain the segmented electrode 202 between tabs 210.Alternative configurations of the tabs 210 are also possible, such as tabs that are obtusely angled, are not angled, and / or tabs that are angled (acutely or obtusely) on one edge, and are not angled, or are angled in the other direction, on the other edge. In some examples, the length of the tabs 210 (measured from the inner surface 212 of the tubular body 208 toward the longitudinal axis 209) can be substantially the same as the thickness of the segmented electrode 202. In some examples, the length of the tabs 210 can be greater than the thickness of the segmented electrode 202. In some examples, the length of the tabs 210 can be less than the thickness of the segmented electrode 202. In some examples, the length of the tabs 210 can vary amongst the tabs 210 (i.e., some tabs 210 can be longer, and some tabs 210 can be shorter).11MF-368639102Attorney Docket No: 78895-20048.40

[0045] As shown in FIG.2C, the method can include inserting the segmented electrodes 202 into the carrier 200, i.e., into the segmented electrode carrying cavities 214 of the tubular body 208. When inserted into the carrier 200, the inner surface 207 of the segmented electrodes 202 can be exposed. In some examples, the conductors 204 can be attached to the segmented electrodes 202 before inserting the segmented electrodes 202 into the carrier 200. In some examples, the conductors 204 can be attached to the segmented electrodes 202 after inserting the segmented electrodes 202 into the carrier 200.

[0046] As illustrated in FIG.2D, the method can include attaching the carrier 200 retaining the segmented electrodes 202 to the distal end of an elongated core 216 of a lead. At least the lead can be skived for attaching the segmented electrodes 202 to the lead. The elongated core 216 can include a plurality of channels 218 for receiving conductors 204 joined to the segmented electrodes 202. The elongated core 216 can include at least one channel 218 for each groove 206 on the segmented electrode 202. Thus, attaching the carrier 200 to the elongated core 216 can include aligning the grooves 206 of the segmented electrodes 202 retained within the carrier 200 with the channels 218 of the elongated core 216. In some examples, the elongated core 216 includes at least one channel 218 (e.g., two channels) for each segmented electrode 202. The shape and size of the channels 218 can be such that the channels 218 can receive conductors 204. For example, the channels 218 may be cylindrical, rectangular, etc. In some examples, the elongated core 216 includes a single channel, or through-hole, for receiving conductors 204 attached to the segmented electrodes 202.

[0047] In some examples, the elongated core 216 can include at least one channel 218 for receiving a portion of the at least one of the tabs 210 protruding from the tubular body 208 of the carrier. Thus, attaching the segmented electrodes 202 retained within the carrier 200 to the elongated core 216 can include inserting the tabs 210 into corresponding channels 218 of the elongated core 216. In some examples, the carrier 200 includes two or more (e.g., three) tabs 210 extending from the tubular body 208 that are inserted into respective channels 218 of the elongated core 216. In this way, the alignment of the segmented electrodes 202 on the elongated core 216 can be retained.

[0048] Following attaching the segmented electrodes 202 retained within the carrier 200 to the elongated core 216 of the lead, the method can include removing the tubular body 208 of the carrier 200, as shown in FIG.2E. The tubular body 208 can be removed such that the tabs 210 from the carrier 200 can be retained between the segmented electrodes 202. In some examples, substantially all the carrier 200 may be removed (including the tabs 210), and a 12MF-368639102Attorney Docket No: 78895-20048.40non-conductive material can be replaced between the segmented electrodes 202 on the elongated core 216 by reflow molding, depositing the material, etc. The carrier 200 (e.g., the tubular body 208) can be removed by machining, such as by centerless grinding, cylindrical grinding, or lathe machining.

[0049] The lead manufacturing method described with respect to FIGS. 2A-2E can be performed with a single set of radially aligned segmented electrodes, or with multiple sets of radially aligned segmented electrodes. For example, the method can be performed multiple times, using a plurality of separate carriers that each retain a set of segmented electrodes (e.g., three segmented electrodes each). In this example, the method may include attaching (e.g., molding) a non-conductive spacer 219 to the elongated core 216 of the lead that separates the sets of segmented electrodes 202 on the lead.

[0050] Alternatively, the method can be performed using a larger carrier 300, as shown in FIG. 3, that can retain multiple sets of segmented electrodes. In the embodiment shown in FIG. 3, the carrier 300 retains a first set 302 and a second set 304 of segmented electrodes. In this example, the carrier 300 can provide a non-conductive spacer 308 between sets of segmented electrodes once the tubular body 306 of the carrier 300 is removed. Alternatively, the carrier 300 may be removed, and a non-conductive spacer may be attached (e.g., molded, deposited, etc.) to the elongated core of the lead to electrically isolate the sets of electrodes. In some examples, a segmented electrode carrier can retain more than two sets of electrodes (e.g., segmented and / or ring electrodes), such as three, four, or more sets of electrodes.

[0051] Returning briefly to the method described with respect to FIGS. 2A-2E, once the segmented electrodes are attached to the elongated core 216, the method can include reflowing a spacer material 219 to the elongated core 216 to form the lead 220. The spacer material 219 can fill any cavities between the elongated core and the segmented electrodes 202, and / or between the segmented electrodes 202 and an un-skived portion of the lead. .

[0052] Another method of manufacturing leads having segmented electrodes can include overmolding the segmented electrodes and subsequently attaching the overmolded segmented electrodes to an elongated core of the lead. FIGS. 4A-4C illustrate such a method. Unless explicitly stated otherwise, the method shown in FIGS. 4A-4C can include any of the steps of the method described with respect to FIGS. 2A-2E. As shown in FIG. 4A, the method can include fabricating the segmented electrodes 400. Fabricating the segmented electrodes 400 can include machining or laser cutting the shape and / or size of the segmented electrodes. Fabricating the segmented electrodes 400 can include machining or laser cutting one or more grooves 402, 402’ (collectively referred to hereinafter as grooves 402) into an inner surface 13MF-368639102Attorney Docket No: 78895-20048.40404 of the segmented electrodes 400. The grooves 402 can include any of the features of grooves 206 described with respect to segmented electrodes 202 illustrated in FIGS. 2A-2E. Once machined, the segmented electrodes 400 (segmented electrodes 400a, 400b, and 400c in FIGS. 4B-4C, collectively referred to herein as segmented electrodes 400) can be removably fixed to a cylindrical core 406 via pins 405 for overmolding the segmented electrodes 400, as shown in FIG.4B. Once overmolded, the segmented electrodes 400 can be removed from the cylindrical core 406, leaving behind the segmented electrodes 400 in a polymer carrier 408, as shown in FIG.4C. The polymer carrier 408 can include any of the features of carrier 200 shown in and described with respect to FIGS.2A-2E. For example, the carrier 408 can be composed of a non-conductive, compliant or non-compliant polymer material that retains the segmented electrodes 400. The carrier 408 can include a tubular body 410 and tabs 412a, 412b, 412c (collectively referred to herein as tabs 412) protruding from the inner surface of the tubular body 410. The carrier 408 can include one or more openings 414a, 414b (collectively referred to hereinafter as openings 414) from where the pins 405 held the segmented electrodes 400 in place on the cylindrical core 406. Despite the openings 414, the carrier 408 can retain the segmented electrodes 400 for attaching to a lead.

[0053] The remainder of the method for manufacturing a lead shown in FIGS.4A-4C can be as described with respect to FIGS.2A-2E. For example, the method can include joining conductors to the inner surface of the segmented electrodes 400. The method can include attaching the segmented electrodes 400 retained in the carrier 408 to a distal end of an elongated core of a lead. In some examples, attaching the segmented electrodes 400 to the distal end of the elongated core includes aligning the grooves 402 on the inner surface 404 of the segmented electrodes 400 with corresponding channels on the elongated core. In some examples, as shown in FIG.4C, the carrier 408 includes at least one tab (e.g., tab 412c in FIG. 4C) that extends farther toward the center of the carrier 408 than the other tabs (e.g., tabs 412a, 412b in FIG.4C) for interlocking with the elongated core. Following attaching the segmented electrodes 400 to the elongated core, the method can include removing the tubular body 410.

[0054] The method described with respect to FIGS.4A-4C can be performed with a single set (e.g., two or more, such as three) of radially aligned segmented electrodes, and / or with multiple sets of radially aligned segmented electrodes. For example, the method can be performed by overmolding multiple sets of segmented electrodes disposed adjacent to one another on the cylindrical core. In some examples, this can include molding a polymer spacer between the sets of segmented electrodes.14MF-368639102Attorney Docket No: 78895-20048.40

[0055] FIGS. 5A-5C illustrate segmented electrodes having retention features that can be used for the segmented electrodes in the methods of FIGS. 2A-2E and / or FIGS. 4A-4C. As shown in FIG. 5A, a segmented electrode 500 (e.g., segmented electrode 500a, 500b, 500c, collectively referred to herein as segmented electrode 500) can include a plurality of notches 502, 502’ (collectively referred to herein as notches 502) disposed along lateral edges 504, 504’ (collectively referred to herein as lateral edges 504) of the segmented electrode 500. In some examples, the notches 502 are disposed along just one of the two lateral edges 504 of the segmented electrode 500. In some examples, the notches 502 are disposed along both the lateral edges 504 of the segmented electrode 500. The notches 502 can improve retention of the segmented electrodes 500 within the carrier 506.

[0056] As shown in FIG. 5B, a segmented electrode 510 (e.g., segmented electrode 510a, 510b, 510c, collectively referred to herein as segmented electrode 510) can include a slot 512 disposed along lateral edges 514 of the segmented electrode 510. The slot 512 can extend less than a full length of the segmented electrode 510. In some examples, the slot 512 is disposed along just one of the two lateral edges 514 of the segmented electrode 510. In some examples, the slot 512 is disposed along both the lateral edges 514 of the segmented electrode 510. The slot 512 can improve retention of the segmented electrodes 510 within the carrier 516.

[0057] As shown in FIG. 5C, a segmented electrode 520 (e.g., 520a, 520b, 520c, collectively referred to hereinafter as segmented electrode 520) can include a slot 522 (e.g., slot 522a, 522a’, 522b, 522b’, 522c, 522c’, collectively referred to hereinafter as slot 522) extending the full length of the segmented electrode 520. In some examples, the slot 522 is disposed along just one of the two lateral edges 524, 524’ (collectively referred to hereinafter as lateral edges 524) of the segmented electrode 520. In some examples, the slot 522 is disposed along both the lateral edges 524 of the segmented electrode 520. The slot 522 can improve retention of the segmented electrodes 520 within the carrier 526. In FIG. 5C, the tabs 528 of the carrier 526 can include corresponding protrusions 529, 529’ (collectively referred to herein as protrusions 529) that are received within the slots 522 of the segmented electrodes 520. For example, the carrier 526 can be manufactured in accordance with the method shown in FIGS. 2A-2E, and the method can include forming the protrusions 529 in the tabs 528. Alternatively, the segmented electrodes 520 can be overmolded in accordance with the method shown in FIGS. 4A-4C, and, when overmolded, the polymer material can fill the slots 522 to form the protrusions 529 in the tabs 528 of the carrier 526.15MF-368639102Attorney Docket No: 78895-20048.40

[0058] FIG. 5D illustrates a polymer carrier 530 that can be used for the polymer carriers in the methods of FIGS.2A-2E and / or FIGS.4A-4C. The polymer carrier 530 can include any of the features described herein with respect to the carrier 200, 300, 408, etc. Polymer carrier 530 may differ from earlier carriers described herein by including an end wall 532 for retaining the segmented electrodes 534a, 534b, 534c (collectively referred to hereinafter as segmented electrodes 534) in the carrier 530. The end wall 532 can aid in inserting the segmented electrodes 534 to a clear stopping point in the carrier 530, ensuring the segmented electrodes 534 are properly retained in the carrier 530. In some examples, the end wall 532 can include one or more grooves 536 for ease of wire routing to the segmented electrodes 534, as shown.Polymer Portions or Overmold for Pre-electrodes That Form Segmented Electrodes

[0059] Methods for manufacturing stimulation and / or sensing leads having segmented electrodes can include the use of a pre-electrode for forming segmented electrodes and polymer portions or polymer overmold. FIGS.6A-6C illustrate a method of manufacturing a lead having segmented electrodes by overmolding a cylindrical pre-electrode 600 that forms segmented electrodes. As shown in FIG.6A, the cylindrical pre-electrode 600 for forming the segmented electrodes can include a monolithic body 601 forming segmented electrode portions 602a, 602b, 602c (collectively referred to hereinafter as segmented electrode portions 602) that are separated by a plurality of gaps 604a, 604b, 604c (collectively referred to hereinafter as gaps 604). For example, a pair of segmented electrode portions 602 can be separated by a gap 604. The gaps 604 can extend a full length of the monolithic body 601. The gaps 604 can partially cut into the monolithic body 601 such that the segmented electrode portions 602 are connected by a core portion 603 of the monolithic body 601. The segmented electrode portions 602 can be radially spaced apart about a longitudinal axis 606 of the pre-electrode 600.

[0060] In some examples, the pre-electrode 600 can include at least one hole 608 extending at least partially through the monolithic body 601, coaxial with the longitudinal axis 606, for holding the pre-electrode 600 in later manufacturing steps. For example, the hole 608 can be a through-hole extending a full length of the monolithic body 601. In another example, the hole 608 includes two holes starting from either end of the monolithic body 601, extending into, but not all the way through, the monolithic body 601. In some examples, the pre-electrode 600 does not include the hole 608.16MF-368639102Attorney Docket No: 78895-20048.40

[0061] As shown in FIG.6B, the method can include overmolding the pre-electrode 600 with a non-conductive polymer material to form a carrier 610 that includes a tubular body 612 covering the pre-electrode 600. The carrier 610 can be composed of any polymer material described herein, e.g., at least with respect to segmented electrode carrier 200 of FIGS.2A-2E. Overmolding the pre-electrode 600 can include filling the gaps 604 of the pre-electrode 600 with the polymer material to form tabs 614a, 614b, 614c (collectively referred to hereinafter as tabs 614) that protrude from an inner surface of the tubular body 612.

[0062] As shown in FIG.6C, the manufacturing method can include generating a through-hole 616 in the molded pre-electrode 600 to remove the core portion 603 of the monolithic body 601, separating the segmented electrode portions 602 into segmented electrodes 618a, 618b, 618c (collectively referred to hereinafter as segmented electrodes 618). The through-hole 616 can intersect the tabs 614 of the carrier 610 such that the tabs 614 retain the segmented electrodes 618 in the carrier 610.

[0063] In some examples, generating the through-hole 616 includes, or is followed by, generating grooves 620, 620’ (collectively referred to hereinafter as grooves 620) on an inner surface 622 of the segmented electrodes 618 for receiving conductor(s) attached to the segmented electrodes 618. The grooves 620 can include any of the features of the grooves 206 generated in the segmented electrodes 202, as described with respect to FIGS.2A-2E herein.

[0064] The method described with respect to FIGS.6A-6C can include any of the steps described with respect to FIGS.2A-2E. For example, the method can include joining conductors (e.g., wires) to the inner surface 622 of the segmented electrodes 618. The method can include attaching the segmented electrodes 618 retained in the carrier 610 to a distal end of an elongated core of a lead. In some examples, attaching the segmented electrodes 618 to the distal end of the elongated core includes aligning the grooves 620 on the inner surface 622 of the segmented electrodes 618 with corresponding channels on the elongated core. Following attaching the segmented electrodes 618 to the elongated core, the method can include removing the tubular body 612.

[0065] The method described with respect to FIGS.6A-6C can be performed with a single set (e.g., two or more, such as three) of radially aligned segmented electrodes, and / or with multiple sets of radially aligned segmented electrodes. For example, the method can be performed by overmolding multiple pre-electrodes disposed adjacent to one another, and generating a through-hole through each of the pre-electrodes.17MF-368639102Attorney Docket No: 78895-20048.40

[0066] In some examples, the method can be performed using an elongated pre-electrode that is sized to form more than one (e.g., two or more) sets of segmented electrodes. This method can include overmolding the elongated pre-electrode, generating a through-hole through the elongated pre-electrode, and machining the molded pre-electrode by cutting the molded pre-electrode into two or more sets of radially aligned pre-electrodes retained by polymer carriers. Each set of pre-electrodes can be separately attached to the distal end of an elongated core of the lead.

[0067] Another method of manufacturing leads having segmented electrodes can include depositing a non-conductive polymer material only into the gaps of a cylindrical pre-electrode. FIGS.7A-7E illustrate such a method with two pre-electrodes 700, 700’ (collectively referred to hereinafter as electrodes 700) separated by a polymer spacer 702. As shown in FIG.7A, the method can include depositing a non-conductive polymer into the gaps 704a, 704b, 704c (collectively referred to hereinafter as gaps 704) of the cylindrical pre-electrodes 700 that separate the radially aligned segmented electrode portions 706a, 706b, 706c (collectively referred to hereinafter as segmented electrode portions 706). The polymer can fill the gaps 704 to form individual tabs 708a, 708a’, 708b, 708c (collectively referred to hereinafter as tabs 708) between the segmented electrode portions 706. The polymer can be any polymer described herein, e.g., with respect to segmented electrode carrier 200 of FIGS.2A-2E.

[0068] Similar to pre-electrode 600 shown in and described with respect to FIGS.6A-6C, the gaps 704 in the pre-electrode 700 can extend partially through the monolithic body 701 of the pre-electrode 700 such that the body 701 includes a core portion 703 that the segmented electrode portions 706 extend outward from. Also, like the pre-electrode 600 described with respect to FIGS.6A-6C, the pre-electrodes 700 can include a hole 710 (e.g., a through-hole) that is coaxial with the longitudinal axis 712 of the pre-electrodes 700 for holding the pre-electrodes 700 in place while depositing the polymer into the gaps 704.

[0069] FIG. 7B illustrates a close-up view of the pre-electrodes 700 shown in FIG.7A.As shown in FIG.7B, the gaps 704 of the pre-electrode 700 can include one or more slots 714a, 714a’, 714b, 714b’, 714c, 714c’ (collectively referred to hereinafter as slots 714) extending at least part of the length of the pre-electrode 700 for receiving polymer, such that the tabs 708 include one or more corresponding protrusions 716a, 716a’, 716b, 716b’, 716c, 716c’ (collectively referred to hereinafter as protrusions 716) that fill the slots 714. The slots 714 in the pre-electrodes 700 and corresponding protrusions 716 in the tabs 708 can improve retention of the segmented electrodes by the tabs 708 after an inner diameter of the pre- 18MF-368639102Attorney Docket No: 78895-20048.40electrodes 700 is machined away, as described with respect to FIG.7C. In some examples, the gaps 704 of the pre-electrode 700 can include one or more protrusions, such that the tabs 708 formed from filling the gaps 704 include one or more corresponding slots. In some examples, one segmented electrode portion on a side of a given gap 704 of a pre-electrode 700 includes a protrusion, and the other segmented electrode portion on the opposing side of the same gap 704 of the pre-electrode includes a slot. In this example, the polymer tab 708 that fills the gap 704 can include a corresponding slot and protrusion, respectively. In some examples, the gap 704 includes just one protrusion or slot on one side.

[0070] As shown in FIG.7C, following depositing the polymer into the gaps 704 of the pre-electrodes 700 to form the tabs 708, the manufacturing method can include generating a through-hole 718 in the pre-electrodes 700 to remove the core portion 703 of the monolithic bodies 701, separating the segmented electrode portions 706 into segmented electrodes 720a, 720a’, 720b, 720b’, and 720c (collectively referred to hereinafter as segmented electrodes 720). The through-hole 718 can intersect the tabs 708 such that only the tabs 708 retain the segmented electrodes 720. Generating the through-hole in the pre-electrodes 700 can include generating a through-hole through the spacer 702 separating multiple pre-electrodes 700 from one another.

[0071] In some examples, generating the through-hole 718 includes, or is followed by, generating grooves on an inner surface 722a, 722a’, 722b, 722c (collectively referred to hereinafter as inner surface 722) of the segmented electrodes 720, as described at least with respect to FIGS.2A-2E, 4A-4C, and 6A-6C. FIGS.7D-7E illustrate grooves 723a, 723b, 723c (collectively referred to hereinafter as grooves 723) in the inner surface 722 of the segmented electrodes 720 for receiving conductor(s) attached to the segmented electrodes 720. The grooves 723 can have any of the features described herein at least with respect to grooves 206 in the segmented electrodes 202, as described with respect to FIGS. 2A-2E. In some examples, each segmented electrode 720 includes at least one groove 723, such as one, two, or more grooves 723.

[0072] The manufacturing method of FIGS.7A-7E can include joining conductors (e.g., wires) to the inner surface 722 of the segmented electrodes 720 (described with respect to the method shown in FIGS.2A-2E). As shown in FIG.7D, the method can include attaching the segmented electrodes 720 to a distal end of an elongated core 724 of a lead. In some examples, the spacer 702 is removed prior to attaching the segmented electrodes 720 to the elongated core 724. In some examples, the spacer 702 is attached to the elongated core 724 with the segmented electrodes 720.19MF-368639102Attorney Docket No: 78895-20048.40

[0073] The elongated core 724 can include any of the features of the elongated core 216 described herein with respect to FIGS.2A-2E. For example, the elongated core 724 can include one or more channels 726a, 726b, 726c (collectively referred to hereinafter as channels 726) for receiving conductors attached to the segmented electrodes 720. In some examples, attaching the segmented electrodes 720 to the distal end of the elongated core 724 includes aligning the grooves 723 on the inner surface 722 of the segmented electrodes 720 with corresponding channels 726 on the elongated core 724, as shown in FIG.7E. In the embodiment shown in FIGS.7A-7E, each segmented electrode 720 includes one groove 723, although the elongated core 724 includes more channels 726. A first portion of the channels 726 can be for a first set of radially aligned segmented electrodes, and a second portion of the channels 726 can be for a second set of radially aligned segmented electrodes (as shown in FIG. 7D) In some examples, a third portion of the channels can align with the tabs 708, as shown in FIG.7E.

[0074] In some examples, following attaching the segmented electrodes 720 to the elongated core 724, the method can include removing the tabs 708 and / or the polymer spacer 702. In this example, the manufacturing method can include reflowing the elongated core 724 having the segmented electrodes 720 attached thereto to cover the elongated core 724 and electrically isolate the segmented electrodes 720 from one another. In embodiments in which the tabs 708 are removed and the elongated core 724 is reflowed to electrically isolate the segmented electrodes 720, the channels 726 aligned with the tabs 708 and gaps from removing the tabs 708 can be filled, improving retention of the segmented electrodes 720 on the elongated core 724. In some examples, the tabs 708 and / or the polymer spacer 702 are left in place on the elongated core 724, and the elongated core 724 can be reflowed only to cover the elongated core 724.

[0075] The method described with respect to FIGS.7A-7E can be performed with multiple sets of radially aligned segmented electrodes (e.g., two, three, or more radially aligned segmented electrodes), as shown in FIGS.7A-7E, and / or with a single set of radially aligned segmented electrodes, as shown in FIGS.8A-8B. A lead having segmented electrodes can be manufactured from the pre-electrode 800 shown in FIGS.8A-8B in a similar fashion as described with respect to FIGS.7A-7E. For example, the method can include depositing polymer in the gaps 802a, 802b, 802c (collectively referred to hereinafter as gaps 802) separating segmented electrode portions 804a, 804b, 804c (collectively referred to hereinafter as segmented electrode portions 804) to form individual tabs 806a, 806b, 806c (collectively referred to hereinafter as tabs 806) between the segmented electrode portions 20MF-368639102Attorney Docket No: 78895-20048.40804. The method can include generating a through-hole in the cylindrical pre-electrode 800 that intersects the tabs 806, resulting in segmented electrodes 808a, 808b, 808c (collectively referred to hereinafter as segmented electrodes 808) retained between the tabs 806.

[0076] The pre-electrode 800 can include any of the features of the pre-electrodes 700 in FIGS.7A-7E. For example, the pre-electrode 800 can include one or more slots 810a, 810b, 810c (collectively referred to hereinafter as slots 810) within the segmented electrode portions 804 that can be filled with polymer, the tabs 806 including corresponding protrusions 812a, 812b, 812c (collectively referred to hereinafter as protrusions 812).Additionally, or alternatively, the pre-electrode 800 can include protrusions in the segmented electrode portions 804, and corresponding slots in the tabs 806. As described herein, the slots and protrusions can improve retention of the segmented electrodes 808 once the inner diameter of the pre-electrode 800 has been machined away. The segmented electrodes 808 can include one or more grooves 814a, 814b, 814c (collectively referred to hereinafter as grooves 814) in the inner surface 809 of the segmented electrodes 808 for receiving conductor(s).Cylindrical Frames for Segmented Electrodes

[0077] Methods for manufacturing stimulation / sensing leads having segmented electrodes can include the use of a non-conductive cylindrical frame that retains the segmented electrodes. FIGS.9A-9D and 10 illustrate various non-conductive cylindrical frames for manufacturing a lead having segmented electrodes by connecting the segmented electrodes to the non-conductive cylindrical frame. As shown in FIG.9A, the cylindrical frame 900 can include one or more segmented electrode carrying openings 904 for retaining segmented electrodes 902a, 902a’, 902b, 902b’, 902c (collectively referred to hereinafter as segmented electrodes 902). The method can include connecting the segmented electrodes 902 to the segmented electrode carrying openings 904. The segmented electrode carrying openings 904 can be defined by one or more arms 906a, 906a’, 906b, 906c (collectively referred to hereinafter as arms 906) that extend axially (i.e., relative to a longitudinal axis 907) from a ring portion 908. For example, each segmented electrode carrying opening 904 can be defined by a pair of arms 906. The arms 906 and / or ring portion 908 of the cylindrical frame 900 can contact the segmented electrodes 902 when the segmented electrodes 902 are fully assembled with the cylindrical frame 900.21MF-368639102Attorney Docket No: 78895-20048.40

[0078] The cylindrical frame 900 can include a rigid, non-conductive material, such as a rigid polymer described herein with respect to segmented electrode carrier 200 in FIGS.2A-2E

[0079] The cylindrical frame 900 (i.e., the arms 906 and / or the ring portion 908 of the cylindrical frame 900) can include one or more retention features for retaining the segmented electrodes 902 within the segmented electrode carrying openings 904. In FIG. 9A, the retention features include one or more protrusions 910a, 910b, 910c (collectively referred to hereinafter as protrusions 910) that protrude from the arms 906, toward the segmented electrode carrying openings 904. One or more edges 912, 912’ (collectively referred to hereinafter as edges 912) of the segmented electrodes 902 can include corresponding slots 914, 914’ (collectively referred to hereinafter as slots 914) that receive the protrusions 910. In the example shown in FIG.9A, the protrusions 910 and corresponding slots 914 extend the full length of the arms 906 and edges 912 of the segmented electrodes 902. Additionally, or alternatively, the edges of the segmented electrodes 902 can include one or more protrusions, and the arms 906 can include one or more corresponding slots.

[0080] The cylindrical frame 920 shown in FIGS. 9B-9C may be similar to cylindrical frame 900 of FIG.9A in that the edges 923 of the segmented electrodes 922a, 922a’, 922b, 922b’, 922c (collectively referred to hereinafter as segmented electrodes 922) and the arms 924 can include slots 926 and protrusions 928, respectively. However, in the embodiment shown in FIGS. 9B-9C, the protrusions 928 on the arms 924a, 924a’, 924b, 924c, 924c’ (collectively referred to hereinafter as arms 924) and the corresponding slots 926 on the segmented electrodes 922 may not extend the full length of the segmented electrodes 922 and arms 924. For example, the protrusions 928 and slots 926 may extend less than about 90%, 75%, 50%, 25%, or another amount therebetween, of the length of the arms 924 and segmented electrodes 922 (respectively). Additionally, or alternatively, the edges 923 of the segmented electrodes 922 can include one or more protrusions, and the arms 924 can include one or more corresponding slots.

[0081] FIG. 9D shows a heat shrink 930 over a segmented electrode and frame assembly 935 that can be used for retaining the segmented electrodes in the cylindrical frame shown in any of FIGS.9A-9C. For example, the segmented electrode and frame assembly 935 can include the cylindrical frame 900 and segmented electrodes 902, or the cylindrical frame 920 and the segmented electrodes 922.

[0082] Methods of manufacturing a lead having segmented electrodes in accordance with FIGS. 9A-9D can include steps of any of the methods described herein, e.g., with respect to 22MF-368639102Attorney Docket No: 78895-20048.40at least FIGS.2A-2E and FIGS.7A-7E. For example, the method can include generating one or more grooves on an inner surface of the segmented electrodes (e.g., grooves 918a, 918b, 918c, collectively referred to hereinafter as grooves 918, on the inner surface 919a, 919b, 919c (collectively referred to hereinafter as inner surface 919) of the segmented electrodes 902 shown in FIG. 9A, grooves 929a, 929b, 929c (collectively referred to hereinafter as grooves 929) on an inner surface 925a, 925b, 925c (collectively referred to hereinafter as inner surface 925) of the segmented electrodes 922 shown in FIGS. 9B-9C) for receiving conductors. The grooves 918, 929 can include any of the features of the grooves 206 generated in the segmented electrodes 202, as described with respect to FIGS.2A-2E herein. Hereinafter in the description of FIGS.9A-9D, the reference numerals of FIG.9A are used for simplicity, but the described methods are understood to be applicable to the cylindrical frame 920 and segmented electrodes 902 shown in FIGS. 9B-9C and the assembly 935 shown in FIG. 9D

[0083] The methods can include joining conductors (e.g., wires) to the inner surface 919 of the segmented electrodes 902. The conductors may be joined to the segmented electrodes 902 before or after the segmented electrodes 902 are inserted into the segmented electrode carrying openings 904 of the cylindrical frame. The methods can include attaching the segmented electrodes 902 retained in the cylindrical frame 900 to a distal end of an elongated core of a lead. In some examples, attaching the segmented electrodes 902 to the distal end of the elongated core includes aligning the grooves 918 on the inner surface 919 of the segmented electrodes 902 with corresponding channels on the elongated core. In some examples, the cylindrical frame 900 can be removed after attaching the segmented electrodes 902 to the elongated core. In this example, reflowing to cover the elongated core can electrically isolate the segmented electrodes 902. In other examples, the cylindrical frame 900 can be maintained in place on the elongated core for electrically isolating the segmented electrodes 902.

[0084] The methods described with respect to FIGS.9A-9D can be performed with multiple sets of radially aligned segmented electrodes 902, as is illustrated, and / or can be performed with a single set (e.g., two or more, such as three) of radially aligned segmented electrodes. For example, a non-conductive cylindrical frame can include one or more arms that extend from only one end of a ring portion of the cylindrical frame, rather than both ends of the ring portion, as is illustrated in FIGS.9A-9D. In this example, the cylindrical frame may retain only one set of segmented electrodes.23MF-368639102Attorney Docket No: 78895-20048.40

[0085] Another method of manufacturing leads having segmented electrodes using a cylindrical frame is illustrated in FIG. 10. Like the cylindrical frames shown in and described with respect to FIGS. 9A-9D, the non-conductive cylindrical frame 1000 can include retention features for retaining the segmented electrodes 1002a, 1002a’, 1002b, 1002b’, 1002c (collectively referred to hereinafter as segmented electrodes 1002) within the segmented electrode carrying openings 1004 of the cylindrical frame 1000. In this embodiment, the retention features can include one or more slots 1006a, 1006b, 1006c, 1006c’ (collectively referred to hereinafter as slots 1006) within the arms 1008a, 1008a’, 1008b, 1008c (collectively referred to hereinafter as arms 1008) that extend from the ring portion 1010 of the cylindrical frame 1000. The slots 1006 can extend a full length of the arms 1008. The slots 1006 can be sized to receive a lateral edge 1012a, 1012b, 1012b’, 1012c, 1012c’ (collectively referred to hereinafter as lateral edge 1012) of the segmented electrodes 1002. Stated another way, the width of the slots 1006 can be substantially the same as the width (or thickness) of the segmented electrodes 1002. The manufacturing method can include inserting the segmented electrodes 1002 into segmented electrode carrying openings 1004 at least partially formed by the slots 1006 within the arms 1008 of the cylindrical frame 1000.

[0086] The method of manufacturing a lead having segmented electrodes in accordance with FIG. 10 can include steps of any of the methods described herein, e.g., with respect to at least FIGS.2A-2E and FIGS.7A-7E. For example, the method can include generating one or more grooves 1014a, 1014b, 1014c (collectively referred to hereinafter as grooves 1014) on an inner surface 1003 a, 1003b, 1003c (collectively referred to hereinafter as inner surface 1003) of the segmented electrodes 1002 for receiving conductors. The grooves 1014 can include any of the features of the grooves 206 generated in the segmented electrodes 202, as described with respect to FIGS.2A-2E herein.

[0087] The method can include joining conductors (e.g., wires) to the inner surface 1003 of the segmented electrodes 1002. The conductors may be joined to the segmented electrodes 1002 before or after the segmented electrodes are inserted into the segmented electrode carrying openings 1004 of the cylindrical frame. The methods can include attaching the segmented electrodes 1002 retained within the cylindrical frame 1000 to a distal end of an elongated core of a lead. In some examples, attaching the segmented electrodes 1002 to the distal end of the elongated core includes aligning the grooves 1014 on the inner surface 1003 of the segmented electrodes 1002 with corresponding channels on the elongated core. In some examples, at least a portion of the cylindrical frame 1000 can be removed after24MF-368639102Attorney Docket No: 78895-20048.40attaching the segmented electrodes 1002 to the elongated core. For example, at least an outer portion standing proud of an external surface of the segmented electrodes 1002 (as shown in FIG. 10) may be machined away, e.g., via centerless grinding or another similar manufacturing process.

[0088] The method described with respect to FIG. 10 can be performed with multiple sets of radially aligned segmented electrodes 1002, as is illustrated, and / or can be performed with a single set (e.g., two or more, such as three) of radially aligned segmented electrodes. For example, a non-conductive cylindrical frame can include one or more arms that extend from only one end of a ring portion of the cylindrical frame, rather than both ends of the ring portion, as is illustrated in FIG. 10. The one or more arms can include slots for retaining edges of the segmented electrodes. In this example, the cylindrical frame may retain only one set of segmented electrodes.

[0089] Although described herein predominantly in the field of neuromodulation, i.e., brain stimulation, it is to be understood that the stimulation leads, and in particular, the preelectrodes provided herein can be usable for stimulating other parts of a human or other animal. For example, the pre-electrodes described herein can be used in manufacturing segmented electrodes for stimulating other nervous system targets, such as the spinal cord, peripheral nerves (e.g., sciatic nerve, femoral nerve, brachial plexus, tibial nerve, occipital nerve), vagus nerve, and / or sacral nerves. In another example, the pre-electrodes described herein can be used in manufacturing segmented electrodes for muscle and / or organ stimulation, such as the diaphragm (e.g., by stimulating the phrenic nerve), the heart (e.g., by stimulating the sinoatrial (SA) node or atrioventricular (AV) node), and / or the gastrointestinal (GI) system (e.g., by stimulating the vagus nerve or stomach muscles).

[0090] Similarly, as described herein, the stimulation leads may additionally or alternatively be configured for sensing characteristics of the surrounding tissue. For example, the stimulation leads may include one or more electrodes configured for sensing chemical analytes or electrical signals in the tissue.Definitions

[0091] As used herein, the singular forms “a,” “an,” and “the” include the plural reference unless the context clearly dictates otherwise.

[0092] Reference to “about” a value or parameter herein includes (and describes) variations that are directed to that value or parameter per se. For example, description referring to “about X” includes description of “X.”25MF-368639102Attorney Docket No: 78895-20048.40

[0093] It is understood that aspects and variations of the invention described herein include “consisting of’ and / or “consisting essentially of’ aspects and variations.

[0094] When a range of values or values is provided, it is to be understood that each intervening value between the upper and lower limit of that range, and any other stated or intervening value in that stated range, is encompassed within the scope of the present disclosure. Where the stated range includes upper or lower limits, ranges excluding either of those included limits are also included in the present disclosure.

[0095] The section headings used herein are for organization purposes only and are not to be constmed as limiting the subject matter described.

[0096] Finally, it is to be understood that features and preferences described in relation to “embodiments” are distinct preferences and are not limited only to that particular embodiment; they may be freely combined with features from other embodiments, where technically feasible, and may form preferred combinations of features. The description is presented to enable one of ordinary skill in the art to make and use the invention and is provided in the context of a patent application and its requirements. Various modifications to the described embodiments will be readily apparent to those persons skilled in the art and the generic principles herein may be applied to other embodiments. Thus, the present invention is not intended to be limited to the embodiment shown but is to be accorded the widest scope consistent with the principles and features described herein.

[0097] The entire disclosure of the patents and publications referred in this application are hereby incorporated herein by reference for all purposes. To the extent that any reference incorporated by reference conflicts with the instant disclosure, the instant disclosure shall control.EXEMPLARY EMBODIMENTS

[0098] The following embodiments are exemplary and are not intended to limit the scope of any invention described herein.

[0099] Embodiment 1. A method of manufacturing a lead, comprising:inserting a plurality of segmented electrodes into a respective plurality of segmented electrode carrying cavities of a non-conductive tubular body, wherein a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities is defined by a pair of tabs of a plurality of tabs protruding from an inner wall of the tubular body such that an inner surface of a segmented electrode of the plurality of segmented electrodes is exposed.26MF-368639102Attorney Docket No: 78895-20048.40

[0100] Embodiment 2. The method of embodiment 1, comprising joining wires to the segmented electrodes prior to inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities of the tubular body.

[0101] Embodiment 3. The method of embodiment 1, comprising joining wires to the segmented electrodes after inserting the plurality of segmented electrodes into the respective segmented electrode carrying cavities of the tubular body.

[0102] Embodiment 4. The method of any one of embodiments 1-3, wherein inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities of the non-conductive tubular body comprises inserting the plurality of segmented electrodes into respective radially aligned segmented electrode carrying cavities of the tubular body.

[0103] Embodiment 5. The method of any one of embodiments 1-4, wherein inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities of the non-conductive tubular body comprises inserting a first set of segmented electrodes into a first radially aligned portion of segmented electrode carrying cavities of the tubular body, and inserting a second set of segmented electrodes into a second radially aligned portion of segmented electrode carrying cavities of the tubular body, wherein the first and second radially aligned portions of segmented electrode carrying cavities are separated by a non-conductive spacer of the tubular body.

[0104] Embodiment 6. The method of any one of embodiments 1-5, wherein inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities of the tubular body comprises inserting three segmented electrodes into three respective segmented electrode carrying cavities.

[0105] Embodiment 7. The method of embodiment 6, wherein the segmented electrode carrying cavities are further defined by an end wall that contacts an end of the segmented electrodes.

[0106] Embodiment 8. The method of any one of embodiments 1-7, comprising attaching the segmented electrodes inserted into the respective plurality of segmented electrode carrying cavities of the tubular body to a distal end of an elongated core.

[0107] Embodiment 9. The method of embodiment 8, comprising, following attaching the segmented electrodes to the distal end of the elongated core, removing the tubular body.

[0108] Embodiment 10. The method of embodiment 8 or 9, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.27MF-368639102Attorney Docket No: 78895-20048.40

[0109] Embodiment 11. The method of embodiment 10, wherein attaching the segmented electrodes to the distal end of the elongated core comprises aligning at least one groove on respective inner surfaces of the segmented electrodes with the channels.

[0110] Embodiment 12. The method of embodiment 10 or 11, wherein attaching the plurality of segmented electrodes to the distal end of the elongated core comprises inserting at least one of the tabs of the tubular body into at least one of the channels of the elongated core.

[0111] Embodiment 13. The method of embodiment 8 or 9, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

[0112] Embodiment 14. The method of any one of embodiments 1-13, comprising generating at least one groove on inner surfaces of the respective segmented electrodes prior to inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities.

[0113] Embodiment 15. The method of any one of embodiments 1-14, comprising generating one or more retention features in at least one edge of the respective segmented electrodes prior to inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities.

[0114] Embodiment 16. A method of manufacturing a lead, comprising:overmolding a cylindrical pre-electrode with a non-conductive polymer to form a tubular body comprising a plurality of tabs, wherein the tabs fill a plurality of gaps separating a plurality of radially spaced segmented electrode portions of the pre-electrode; and generating a hole through the cylindrical pre-electrode that intersects the tabs to generate a plurality of segmented electrodes retained by the tubular body.

[0115] Embodiment 17. The method of embodiment 16, comprising joining wires to the segmented electrodes.

[0116] Embodiment 18. The method of embodiment 16 or 17, wherein generating the plurality of segmented electrodes comprises generating a first set of radially aligned segmented electrodes, and generating a second set of radially aligned segmented electrodes adjacent to the first set of radially aligned segmented electrodes.

[0117] Embodiment 19. The method of any one of embodiments 16-18, wherein generating the plurality of segmented electrodes comprises generating three segmented electrodes.

[0118] Embodiment 20. The method of any one of embodiments 16-19, comprising attaching the segmented electrodes retained in the tubular body to a distal end of an elongated core.28MF-368639102Attorney Docket No: 78895-20048.40

[0119] Embodiment 21. The method of embodiment 20, comprising, following attaching the segmented electrodes to the distal end of the elongated core, removing the tubular body.

[0120] Embodiment 22. The method of embodiment 20 or 21, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

[0121] Embodiment 23. The method of any one of embodiments 16-22, wherein generating the hole through the cylindrical pre-electrode comprises generating at least one groove on respective inner surfaces of the segmented electrodes.

[0122] Embodiment 24. The method of any one of embodiments 16-23, comprising, following generating the hole through the cylindrical pre-electrode, generating at least one groove on respective inner surfaces of the segmented electrodes.

[0123] Embodiment 25. The method of any one of embodiments 20-24, wherein attaching the segmented electrodes to the distal end of the elongated core comprises aligning grooves on respective inner surfaces of segmented electrodes with the channels.

[0124] Embodiment 26. The method of embodiment 20 or 21, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

[0125] Embodiment 27. A method of manufacturing a lead, comprising:depositing a non-conductive polymer into a plurality of gaps of a cylindrical pre-electrode to form a plurality of polymer tabs separating a plurality of radially spaced segmented electrode portions of the cylindrical pre-electrode; andgenerating a hole through the cylindrical pre-electrode that intersects the plurality of polymer tabs to generate a plurality of segmented electrodes retained by the plurality of polymer tabs.

[0126] Embodiment 28. The method of embodiment 27, comprising joining wires to the segmented electrodes.

[0127] Embodiment 29. The method of embodiment 27 or 28, wherein generating the plurality of segmented electrodes comprises generating a first set of radially aligned segmented electrodes, and generating a second set of radially aligned segmented electrodes adjacent to the first set of radially aligned segmented electrodes.

[0128] Embodiment 30. The method of any one of embodiments 27-29, wherein generating the plurality of segmented electrodes comprises generating three segmented electrodes.29MF-368639102Attorney Docket No: 78895-20048.40

[0129] Embodiment 31. The method of any one of embodiments 27-30, comprising attaching the plurality of segmented electrodes retained by the plurality of polymer tabs to a distal end of an elongated core.

[0130] Embodiment 32. The method of embodiment 31, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

[0131] Embodiment 33. The method of any one of embodiments 27-32, wherein generating the hole through the cylindrical pre-electrode comprises generating at least one groove on respective inner surfaces of the segmented electrodes.

[0132] Embodiment 34. The method of any one of embodiments 27-33, comprising, following generating the hole through the cylindrical pre-electrode, generating at least one groove on respective inner surfaces of the segmented electrodes.

[0133] Embodiment 35. The method of any one of embodiments 31-34, wherein attaching the plurality of segmented electrodes to the distal end of the elongated core comprises aligning at least one groove on respective inner surfaces of the segmented electrodes with the channels.

[0134] Embodiment 36. The method of embodiment 31, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

[0135] Embodiment 37. A method of manufacturing a lead, comprising:connecting a plurality of segmented electrodes to a respective plurality of segmented electrode carrying openings of a non-conductive cylindrical frame that are defined by a pair of arms extending axially from a ring portion contacting each of the plurality of segmented electrodes,wherein retention features of the ring portion and / or the arms retain the segmented electrodes within the segmented electrode carrying openings.

[0136] Embodiment 38. The method of embodiment 37, comprising joining wires to the segmented electrodes prior to connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame.

[0137] Embodiment 39. The method of embodiment 37, comprising joining wires to the segmented electrodes after connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame.

[0138] Embodiment 40. The method of any one of embodiments 37-39, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises inserting edges of the plurality of segmented electrodes into respective receiving slots of the arms.30MF-368639102Attorney Docket No: 78895-20048.40

[0139] Embodiment 41. The method of any one of embodiments 37-40, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises inserting edges of the arms into respective receiving slots of the segmented electrodes.

[0140] Embodiment 42. The method of embodiment 41, wherein the receiving slots span a length of the segmented electrodes.

[0141] Embodiment 43. The method of embodiment 41, wherein the receiving slots span less than a length of the segmented electrodes.

[0142] Embodiment 44. The method of any one of embodiments 37-43, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises connecting the plurality of segmented electrodes to respective radially aligned segmented electrode carrying openings of the cylindrical frame.

[0143] Embodiment 45. The method of any one of embodiments 37-44, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises connecting a first plurality of segmented electrodes to a first radially aligned portion of segmented electrode carrying openings of the cylindrical frame, and connecting a second plurality of segmented electrodes into a second radially aligned portion of segmented electrode carrying openings of the cylindrical frame, the first and second radially aligned portions of the segmented electrode carrying openings separated by the ring portion of the cylindrical frame.

[0144] Embodiment 46. The method of any one of embodiments 37-45, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises connecting three segmented electrodes to three respective segmented electrode carrying openings.

[0145] Embodiment 47. The method of any one of embodiments 37-46, comprising attaching the plurality of segmented electrodes connected to the respective plurality of segmented electrode carrying openings of the cylindrical frame to a distal end of an elongated core.

[0146] Embodiment 48. The method of embodiment 47, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

[0147] Embodiment 49. The method of embodiment 48, wherein attaching the plurality of segmented electrodes to the distal end of the elongated core comprises aligning grooves on respective inner surfaces of the segmented electrodes with the channels.31MF-368639102Attorney Docket No: 78895-20048.40

[0148] Embodiment 50. The method of embodiment 48 or 49, wherein attaching the plurality of segmented electrodes to the distal end of the elongated core comprises inserting a portion of at least one arm of the plurality of arms into at least one of the channels of the elongated core.

[0149] Embodiment 51. The method of embodiment 47, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

[0150] Embodiment 52. The method of any one of embodiments 37-51, comprising generating at least one groove on respective inner surfaces of the segmented electrodes prior to connecting the plurality of segmented electrodes to the respective segmented electrode carrying openings.

[0151] Embodiment 53. An assembly for manufacturing a lead, comprising:a plurality of segmented electrodes; anda non-conductive tubular body comprising:a plurality of tabs protruding from an inner wall of the tubular body; and a plurality of segmented electrode carrying cavities, wherein a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities is defined along the inner wall of the tubular body by a pair of the plurality of tabs, and wherein an inner surface of a segmented electrode of the plurality of segmented electrodes is exposed when the segmented electrode is retained in a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities.

[0152] Embodiment 54. The assembly of embodiment 53, comprising wires joined to the segmented electrodes.

[0153] Embodiment 55. The assembly of embodiment 53 or 54, wherein the segmented electrode carrying cavities of the tubular body are radially aligned.

[0154] Embodiment 56. The assembly of any one of embodiments 53-55, wherein the plurality of segmented electrode carrying cavities of the tubular body comprises a first set of radially aligned segmented electrodes carrying cavities and a second set of radially aligned segmented electrodes carrying cavities of the tubular body, and the tubular body comprises a non-conductive spacer separating the first and second sets of radially aligned segmented electrodes.

[0155] Embodiment 57. The assembly of any one of embodiments 53-56, wherein the tubular body comprises an end wall further defining the segmented electrode carrying cavities.32MF-368639102Attorney Docket No: 78895-20048.40

[0156] Embodiment 58. The assembly of any one of embodiments 53-57, wherein the plurality of segmented electrode carrying cavities comprises three segmented electrode carrying cavities.

[0157] Embodiment 59. The assembly of any one of embodiments 53-58, wherein the tubular body retaining the segmented electrodes is configured to be attached to a distal end of an elongated core of a lead.

[0158] Embodiment 60. The assembly of embodiment 59, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

[0159] Embodiment 61. The assembly of embodiment 60, wherein the segmented electrodes comprise at least one groove on respective inner surfaces of the segmented electrodes that is configured to be aligned with the channels when the tubular body retaining the segmented electrodes is attached to the elongated core.

[0160] Embodiment 62. The assembly of embodiment 60 or 61, wherein a portion of at least one of the plurality of tabs of the tubular body is configured to be inserted into at least one of the plurality of channels of the elongated core when the tubular body is attached to the elongated core.

[0161] Embodiment 63. The assembly of embodiment 59, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

[0162] Embodiment 64. The assembly of any one of embodiments 53-63, comprising one or more retention features in at least one edge of the respective segmented electrodes.

[0163] Embodiment 65. An assembly for manufacturing a lead, comprising:a cylindrical pre-electrode comprising a plurality of radially spaced segmented electrode portions, a pair of the plurality of segmented electrode portions spaced apart by a gap of a plurality of gaps; anda non-conductive polymer overmolded onto the pre-electrode to form i) a tubular body having a plurality of tabs and / or ii) a plurality of individual tabs, wherein the tabs and / or the individual tabs fill the plurality of gaps to separate the segmented electrodes.

[0164] Embodiment 66. The assembly of embodiment 65, comprising the tubular body having a plurality of tabs.

[0165] Embodiment 67. The assembly of embodiment 65, comprising the plurality of individual tabs separating the segmented electrodes.

[0166] Embodiment 68. The assembly of any one of embodiments 65-67, comprising wires joined to the segmented electrodes.33MF-368639102Attorney Docket No: 78895-20048.40

[0167] Embodiment 69. The assembly of any one of embodiments 65-68, wherein the plurality of segmented electrode portions comprises a first set of radially aligned segmented electrode portions and a second set of radially aligned segmented electrode portions.

[0168] Embodiment 70. The assembly of any one of embodiments 65-69, wherein the plurality of segmented electrode portions comprises three segmented electrode portions.

[0169] Embodiment 71. The assembly of any one of embodiments 65-70, wherein, with an inner diameter of the pre-electrode removed, the tubular body having the plurality of tabs and / or the plurality of individual tabs retaining the segmented electrodes is configured to be attached to a distal end of an elongated core.

[0170] Embodiment 72. The assembly of embodiment 71, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

[0171] Embodiment 73. The assembly of embodiment 72, wherein the segmented electrodes comprise at least one groove on inner surfaces of the respective segmented electrodes that is configured to be aligned with the channels when the tubular body having the plurality of tabs and / or the plurality of individual tabs retaining the segmented electrodes is attached to the elongated core.

[0172] Embodiment 74. The assembly of embodiment 71, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

[0173] Embodiment 75. An assembly for manufacturing a lead, comprising:a plurality of segmented electrodes; anda non-conductive cylindrical frame comprising:a ring portion that contacts ends of the respective segmented electrodes; a plurality of arms extending axially from the ring portion; and a plurality of segmented electrode carrying openings, a segmented electrode carrying opening of the plurality of segmented electrode carrying openings defined by a pair of the plurality of arms and the ring portion,wherein an arm of the plurality of arms and / or a segmented electrode of the plurality of segmented electrodes comprises a retention feature configured for retaining the segmented electrode within a given segmented electrode carrying opening.

[0174] Embodiment 76. The assembly of embodiment 75, comprising wires joined to the segmented electrodes.

[0175] Embodiment 77. The assembly of embodiment 75 or 76, wherein the arm comprises the retention feature, the retention feature comprising at least one slot configured for receiving at least one edge of the given segmented electrode.34MF-368639102Attorney Docket No: 78895-20048.40

[0176] Embodiment 78. The assembly of any one of embodiments 75-77, wherein the segmented electrode comprises the retention feature, the retention feature comprising at least one slot configured for receiving at least one edge of the arm.

[0177] Embodiment 79. The assembly of embodiment 78, wherein the slot spans a length of the segmented electrode.

[0178] Embodiment 80. The assembly of embodiment 78, wherein the slot spans less than a length of the segmented electrode.

[0179] Embodiment 81. The assembly of any one of embodiments 75-80, wherein the segmented electrode carrying openings of the cylindrical frame are radially aligned.

[0180] Embodiment 82. The assembly of any one of embodiments 75-81, wherein the plurality of segmented electrode carrying openings of the cylindrical frame comprises a first set of radially aligned segmented electrodes carrying openings and a second set of radially aligned segmented electrodes carrying openings, the first and second sets of radially aligned segmented electrode carrying openings separated by the ring portion of the cylindrical frame.

[0181] Embodiment 83. The assembly of any one of embodiments 75-82, wherein the plurality of segmented electrode carrying openings comprises three segmented electrode carrying openings.

[0182] Embodiment 84. The assembly of any one of embodiments 75-83, wherein the cylindrical frame retaining the segmented electrodes is configured to be attached to a distal end of an elongated core of a lead.

[0183] Embodiment 85. The assembly of embodiment 84, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

[0184] Embodiment 86. The assembly of embodiment 85, wherein the segmented electrodes comprise at least one groove on respective inner surfaces of the segmented electrodes that are configured to be aligned with the channels when the tubular body retaining the segmented electrodes is attached to the elongated core.

[0185] Embodiment 87. The assembly of embodiment 85 or 86, wherein a portion of at least one of the plurality of arms is configured to be inserted into at least one of the channels of the elongated core when the cylindrical frame is attached to the elongated core.

[0186] Embodiment 88. The assembly of embodiment 84, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.35MF-368639102Attorney Docket No: 78895-20048.40Conclusion

[0187] The foregoing description, for the purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various embodiments with various modifications as are suited to the particular use contemplated.

[0188] Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims.36MF-368639102

Claims

Attorney Docket No: 78895-20048.40CLAIMSWhat is claimed is:

1. A method of manufacturing a lead, comprising:inserting a plurality of segmented electrodes into a respective plurality of segmented electrode carrying cavities of a non-conductive tubular body, wherein a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities is defined by a pair of tabs of a plurality of tabs protruding from an inner wall of the tubular body such that an inner surface of a segmented electrode of the plurality of segmented electrodes is exposed.

2. The method of claim 1, comprising joining wires to the segmented electrodes prior to inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities of the tubular body.

3. The method of claim 1, comprising joining wires to the segmented electrodes after inserting the plurality of segmented electrodes into the respective segmented electrode carrying cavities of the tubular body.

4. The method of any one of claims 1-3, wherein inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities of the non-conductive tubular body comprises inserting the plurality of segmented electrodes into respective radially aligned segmented electrode carrying cavities of the tubular body.

5. The method of any one of claims 1-4, wherein inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities of the non-conductive tubular body comprises inserting a first set of segmented electrodes into a first radially aligned portion of segmented electrode carrying cavities of the tubular body, and inserting a second set of segmented electrodes into a second radially aligned portion of segmented electrode carrying cavities of the tubular body, wherein the first and second radially aligned portions of segmented electrode carrying cavities are separated by a non-conductive spacer of the tubular body.

6. The method of any one of claims 1-5, wherein inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities of the tubular37MF-368639102Attorney Docket No: 78895-20048.40body comprises inserting three segmented electrodes into three respective segmented electrode carrying cavities.

7. The method of claim 6, wherein the segmented electrode carrying cavities are further defined by an end wall that contacts an end of the segmented electrodes.

8. The method of any one of claims 1-7, comprising attaching the segmented electrodes inserted into the respective plurality of segmented electrode carrying cavities of the tubular body to a distal end of an elongated core.

9. The method of claim 8, comprising, following attaching the segmented electrodes to the distal end of the elongated core, removing the tubular body.

10. The method of claim 8 or 9, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

11. The method of claim 10, wherein attaching the segmented electrodes to the distal end of the elongated core comprises aligning at least one groove on respective inner surfaces of the segmented electrodes with the channels.

12. The method of claim 10 or 11, wherein attaching the plurality of segmented electrodes to the distal end of the elongated core comprises inserting at least one of the tabs of the tubular body into at least one of the channels of the elongated core.

13. The method of claim 8 or 9, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

14. The method of any one of claims 1-13, comprising generating at least one groove on inner surfaces of the respective segmented electrodes prior to inserting the plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities.

15. The method of any one of claims 1-14, comprising generating one or more retention features in at least one edge of the respective segmented electrodes prior to inserting the38MF-368639102Attorney Docket No: 78895-20048.40plurality of segmented electrodes into the respective plurality of segmented electrode carrying cavities.

16. A method of manufacturing a lead, comprising:overmolding a cylindrical pre-electrode with a non-conductive polymer to form a tubular body comprising a plurality of tabs, wherein the tabs fill a plurality of gaps separating a plurality of radially spaced segmented electrode portions of the pre-electrode; and generating a hole through the cylindrical pre-electrode that intersects the tabs to generate a plurality of segmented electrodes retained by the tubular body.

17. The method of claim 16, comprising joining wires to the segmented electrodes.

18. The method of claim 16 or 17, wherein generating the plurality of segmented electrodes comprises generating a first set of radially aligned segmented electrodes, and generating a second set of radially aligned segmented electrodes adjacent to the first set of radially aligned segmented electrodes.

19. The method of any one of claims 16-18, wherein generating the plurality of segmented electrodes comprises generating three segmented electrodes.

20. The method of any one of claims 16-19, comprising attaching the segmented electrodes retained in the tubular body to a distal end of an elongated core.

21. The method of claim 20, comprising, following attaching the segmented electrodes to the distal end of the elongated core, removing the tubular body.

22. The method of claim 20 or 21, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

23. The method of any one of claims 16-22, wherein generating the hole through the cylindrical pre-electrode comprises generating at least one groove on respective inner surfaces of the segmented electrodes.39MF-368639102Attorney Docket No: 78895-20048.4024. The method of any one of claims 16-23, comprising, following generating the hole through the cylindrical pre-electrode, generating at least one groove on respective inner surfaces of the segmented electrodes.

25. The method of any one of claims 20-24, wherein attaching the segmented electrodes to the distal end of the elongated core comprises aligning grooves on respective inner surfaces of segmented electrodes with the channels.

26. The method of claim 20 or 21, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

27. A method of manufacturing a lead, comprising:depositing a non-conductive polymer into a plurality of gaps of a cylindrical preelectrode to form a plurality of polymer tabs separating a plurality of radially spaced segmented electrode portions of the cylindrical pre-electrode; andgenerating a hole through the cylindrical pre-electrode that intersects the plurality of polymer tabs to generate a plurality of segmented electrodes retained by the plurality of polymer tabs.

28. The method of claim 27, comprising joining wires to the segmented electrodes.

29. The method of claim 27 or 28, wherein generating the plurality of segmented electrodes comprises generating a first set of radially aligned segmented electrodes, and generating a second set of radially aligned segmented electrodes adjacent to the first set of radially aligned segmented electrodes.

30. The method of any one of claims 27-29, wherein generating the plurality of segmented electrodes comprises generating three segmented electrodes.

31. The method of any one of claims 27-30, comprising attaching the plurality of segmented electrodes retained by the plurality of polymer tabs to a distal end of an elongated core.40MF-368639102Attorney Docket No: 78895-20048.4032. The method of claim 31, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

33. The method of any one of claims 27-32, wherein generating the hole through the cylindrical pre-electrode comprises generating at least one groove on respective inner surfaces of the segmented electrodes.

34. The method of any one of claims 27-33, comprising, following generating the hole through the cylindrical pre-electrode, generating at least one groove on respective inner surfaces of the segmented electrodes.

35. The method of any one of claims 31-34, wherein attaching the plurality of segmented electrodes to the distal end of the elongated core comprises aligning at least one groove on respective inner surfaces of the segmented electrodes with the channels.

36. The method of claim 31, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

37. A method of manufacturing a lead, comprising:connecting a plurality of segmented electrodes to a respective plurality of segmented electrode carrying openings of a non-conductive cylindrical frame that are defined by a pair of arms extending axially from a ring portion contacting each of the plurality of segmented electrodes,wherein retention features of the ring portion and / or the arms retain the segmented electrodes within the segmented electrode carrying openings.

38. The method of claim 37, comprising joining wires to the segmented electrodes prior to connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame.

39. The method of claim 37, comprising joining wires to the segmented electrodes after connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame.41MF-368639102Attorney Docket No: 78895-20048.4040. The method of any one of claims 37-39, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises inserting edges of the plurality of segmented electrodes into respective receiving slots of the arms.

41. The method of any one of claims 37-40, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises inserting edges of the arms into respective receiving slots of the segmented electrodes.

42. The method of claim 41, wherein the receiving slots span a length of the segmented electrodes.

43. The method of claim 41, wherein the receiving slots span less than a length of the segmented electrodes.

44. The method of any one of claims 37-43, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises connecting the plurality of segmented electrodes to respective radially aligned segmented electrode carrying openings of the cylindrical frame.

45. The method of any one of claims 37-44, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises connecting a first plurality of segmented electrodes to a first radially aligned portion of segmented electrode carrying openings of the cylindrical frame, and connecting a second plurality of segmented electrodes into a second radially aligned portion of segmented electrode carrying openings of the cylindrical frame, the first and second radially aligned portions of the segmented electrode carrying openings separated by the ring portion of the cylindrical frame.

46. The method of any one of claims 37-45, wherein connecting the plurality of segmented electrodes to the respective plurality of segmented electrode carrying openings of the cylindrical frame comprises connecting three segmented electrodes to three respective segmented electrode carrying openings.42MF-368639102Attorney Docket No: 78895-20048.4047. The method of any one of claims 37-46, comprising attaching the plurality of segmented electrodes connected to the respective plurality of segmented electrode carrying openings of the cylindrical frame to a distal end of an elongated core.

48. The method of claim 47, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

49. The method of claim 48, wherein attaching the plurality of segmented electrodes to the distal end of the elongated core comprises aligning grooves on respective inner surfaces of the segmented electrodes with the channels.

50. The method of claim 48 or 49, wherein attaching the plurality of segmented electrodes to the distal end of the elongated core comprises inserting a portion of at least one arm of the plurality of arms into at least one of the channels of the elongated core.

51. The method of claim 47, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

52. The method of any one of claims 37-51, comprising generating at least one groove on respective inner surfaces of the segmented electrodes prior to connecting the plurality of segmented electrodes to the respective segmented electrode carrying openings.

53. An assembly for manufacturing a lead, comprising:a plurality of segmented electrodes; anda non-conductive tubular body comprising:a plurality of tabs protruding from an inner wall of the tubular body; and a plurality of segmented electrode carrying cavities, wherein a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities is defined along the inner wall of the tubular body by a pair of the plurality of tabs, and wherein an inner surface of a segmented electrode of the plurality of segmented electrodes is exposed when the segmented electrode is retained in a segmented electrode carrying cavity of the plurality of segmented electrode carrying cavities.43MF-368639102Attorney Docket No: 78895-20048.4054. The assembly of claim 53, comprising wires joined to the segmented electrodes.

55. The assembly of claim 53 or 54, wherein the segmented electrode carrying cavities of the tubular body are radially aligned.

56. The assembly of any one of claims 53-55, wherein the plurality of segmented electrode carrying cavities of the tubular body comprises a first set of radially aligned segmented electrodes carrying cavities and a second set of radially aligned segmented electrodes carrying cavities of the tubular body, and the tubular body comprises a non-conductive spacer separating the first and second sets of radially aligned segmented electrodes.

57. The assembly of any one of claims 53-56, wherein the tubular body comprises an end wall further defining the segmented electrode carrying cavities.

58. The assembly of any one of claims 53-57, wherein the plurality of segmented electrode carrying cavities comprises three segmented electrode carrying cavities.

59. The assembly of any one of claims 53-58, wherein the tubular body retaining the segmented electrodes is configured to be attached to a distal end of an elongated core of a lead.

60. The assembly of claim 59, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

61. The assembly of claim 60, wherein the segmented electrodes comprise at least one groove on respective inner surfaces of the segmented electrodes that is configured to be aligned with the channels when the tubular body retaining the segmented electrodes is attached to the elongated core.

62. The assembly of claim 60 or 61, wherein a portion of at least one of the plurality of tabs of the tubular body is configured to be inserted into at least one of the plurality of channels of the elongated core when the tubular body is attached to the elongated core.44MF-368639102Attorney Docket No: 78895-20048.4063. The assembly of claim 59, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

64. The assembly of any one of claims 53-63, comprising one or more retention features in at least one edge of the respective segmented electrodes.

65. An assembly for manufacturing a lead, comprising:a cylindrical pre-electrode comprising a plurality of radially spaced segmented electrode portions, a pair of the plurality of segmented electrode portions spaced apart by a gap of a plurality of gaps; anda non-conductive polymer overmolded onto the pre-electrode to form i) a tubular body having a plurality of tabs and / or ii) a plurality of individual tabs, wherein the tabs and / or the individual tabs fill the plurality of gaps to separate the segmented electrodes.

66. The assembly of claim 65, comprising the tubular body having a plurality of tabs.

67. The assembly of claim 65, comprising the plurality of individual tabs separating the segmented electrodes.

68. The assembly of any one of claims 65-67, comprising wires joined to the segmented electrodes.

69. The assembly of any one of claims 65-68, wherein the plurality of segmented electrode portions comprises a first set of radially aligned segmented electrode portions and a second set of radially aligned segmented electrode portions.

70. The assembly of any one of claims 65-69, wherein the plurality of segmented electrode portions comprises three segmented electrode portions.

71. The assembly of any one of claims 65-70, wherein, with an inner diameter of the pre-electrode removed, the tubular body having the plurality of tabs and / or the plurality of individual tabs retaining the segmented electrodes is configured to be attached to a distal end of an elongated core.45MF-368639102Attorney Docket No: 78895-20048.4072. The assembly of claim 71, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

73. The assembly of claim 72, wherein the segmented electrodes comprise at least one groove on inner surfaces of the respective segmented electrodes that is configured to be aligned with the channels when the tubular body having the plurality of tabs and / or the plurality of individual tabs retaining the segmented electrodes is attached to the elongated core.

74. The assembly of claim 71, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.

75. An assembly for manufacturing a lead, comprising:a plurality of segmented electrodes; anda non-conductive cylindrical frame comprising:a ring portion that contacts ends of the respective segmented electrodes; a plurality of arms extending axially from the ring portion; and a plurality of segmented electrode carrying openings, a segmented electrode carrying opening of the plurality of segmented electrode carrying openings defined by a pair of the plurality of arms and the ring portion,wherein an arm of the plurality of arms and / or a segmented electrode of the plurality of segmented electrodes comprises a retention feature configured for retaining the segmented electrode within a given segmented electrode carrying opening.

76. The assembly of claim 75, comprising wires joined to the segmented electrodes.

77. The assembly of claim 75 or 76, wherein the arm comprises the retention feature, the retention feature comprising at least one slot configured for receiving at least one edge of the given segmented electrode.

78. The assembly of any one of claims 75-77, wherein the segmented electrode comprises the retention feature, the retention feature comprising at least one slot configured for receiving at least one edge of the arm.46MF-368639102Attorney Docket No: 78895-20048.4079. The assembly of claim 78, wherein the slot spans a length of the segmented electrode.

80. The assembly of claim 78, wherein the slot spans less than a length of the segmented electrode.

81. The assembly of any one of claims 75-80, wherein the segmented electrode carrying openings of the cylindrical frame are radially aligned.

82. The assembly of any one of claims 75-81, wherein the plurality of segmented electrode carrying openings of the cylindrical frame comprises a first set of radially aligned segmented electrodes carrying openings and a second set of radially aligned segmented electrodes carrying openings, the first and second sets of radially aligned segmented electrode carrying openings separated by the ring portion of the cylindrical frame.

83. The assembly of any one of claims 75-82, wherein the plurality of segmented electrode carrying openings comprises three segmented electrode carrying openings.

84. The assembly of any one of claims 75-83, wherein the cylindrical frame retaining the segmented electrodes is configured to be attached to a distal end of an elongated core of a lead.

85. The assembly of claim 84, wherein the elongated core comprises a plurality of channels for receiving wires joined to the segmented electrodes.

86. The assembly of claim 85, wherein the segmented electrodes comprise at least one groove on respective inner surfaces of the segmented electrodes that are configured to be aligned with the channels when the tubular body retaining the segmented electrodes is attached to the elongated core.

87. The assembly of claim 85 or 86, wherein a portion of at least one of the plurality of arms is configured to be inserted into at least one of the channels of the elongated core when the cylindrical frame is attached to the elongated core.47MF-368639102Attorney Docket No: 78895-20048.4088. The assembly of claim 84, wherein the elongated core comprises a single channel for receiving wires joined to the segmented electrodes.48MF-368639102

Images