Implantable stimulator and stimulation system

Abstract

Mismatches in the curvature of electrode lead sections can result in unexpected / unpredictable electrical resistance with the underlying tissue. Additionally, repeated movement of the relevant body region can further exacerbate the mismatch. Electrical stimulation implants traditionally require low-resistance conductors for the stimulation electrode, return electrode, and interconnects, using metal wires and contacts. These conductors reduce flexibility, a problem exacerbated as the number of electrodes increases to provide greater customization. The implantable stimulation device includes an elongated substrate 300, an interconnect 250, 450, and a flexible electrode 200, 400 having two portions separated by a bending interruption 500, 371, 372, 373, 374, 375, with the first and second portions directly electrically connected via the interconnect. The electrode portions on either side of the bending point are electrically connected, allowing for separate optimization of the mechanical bending and the electrical connection.

Description

[Technical field]

[0001] The present disclosure relates to an implantable stimulator for providing electrical stimulation with flexible electrodes. The present disclosure also relates to a stimulation system including such an implantable stimulator. [Background technology]

[0002] Implantable electrical stimulation systems may be used to provide electrical stimulation therapy to a patient to treat a variety of symptoms or conditions, such as headaches, back pain, and incontinence.

[0003] In many electrical stimulation applications, it is desirable for a stimulator, typically comprising a therapeutic lead (where the lead comprises an electrode and an electrical connection), to provide electrical stimulation to one or more precise locations within the body, and precise alignment of the stimulating electrodes at implantation can often be difficult due to the curvature of tissue and anatomy. Mismatches in the curvature of the electrode sections of the lead can result in unexpected and / or unpredictable electrical resistance between one or more electrodes and the underlying tissue. In addition, repeated movement of the relevant body area can further exacerbate the mismatch. A separate issue with subcutaneous implants is that even slight differences in flexibility between the implant and the surrounding tissue can affect patient comfort and can cause irritation of the overlying skin.

[0004] Recently, polymers have been used due to their inherent flexibility. However, implants for electrical stimulation require low resistance conductors for the stimulation electrode, return electrode, and interconnects, which traditionally use metal for the wires and contacts. These conductors reduce flexibility, a problem that worsens as the size of the electrodes increases due to the desire to provide greater customization, provide more functionality, or reduce electrical resistance.

[0005] US Patent Application Publication No. 2015 / 099959 describes an implantable electrode array that includes an organic substrate material configured to be implanted and optionally dissolved and absorbed in an in vivo environment, and electrodes mounted to the organic substrate material and configured to acquire signals generated by the in vivo environment. The electrode array includes connection pads mounted to the organic substrate and MRI compatible conductive traces formed between the electrodes and the connection pads.

[0006] PCT application WO 2018 / 122824 describes a cortical stimulation and recording electrode with a flexible support element for at least one conductive element having a tip and a tip. The conductive element has at least one tip contact and at least one tip contact arranged at the tip and the tip of the flexible support element, respectively, such that the conductive element transmits a signal from the tip contact to the tip contact and vice versa. Furthermore, the conductive element is composed of a conductive track formed from a layer of conductive ink deposited on the flexible support element.

[0007] US Patent Application Publication No. 2018 / 0008821 describes a thin film device and a method of manufacturing and implanting the thin film device. In one implementation, a molded insulator is formed having an inner surface, an outer surface, and a profile molded according to a selected dielectric application. A layer of conductive traces is fabricated on the inner surface of the molded insulator using a biocompatible metallization. An insulating layer is applied over the layer of conductive traces. An electrode array and a connection array are fabricated on the outer surface of the molded insulator and / or the insulating layer, the electrode array and the connection array being in electrical communication with the layer of conductive traces to form a flexible circuit. An implantable thin film device is formed from the flexible circuit according to a selected dialectic application.

[0008] It is an object of the present invention to provide an improved implantable stimulator device with multiple conductors that provides greater compatibility with surrounding tissue and anatomy. Summary of the Invention

[0009] According to a first aspect of the present disclosure, there is provided an implantable stimulation device comprising an elongated substrate disposed along a longitudinal axis having a first surface and a second surface disposed along substantially parallel transverse planes, the elongated substrate further comprising a flexible electrode included on the first surface or the second surface, the flexible electrode configured to contact human or animal tissue in use, and one or more interconnects disposed between the first surface and the second surface, the flexible electrode further comprising a first portion disposed along a first partial plane and a second portion disposed along a second partial plane, the first portion and the second portion directly electrically connecting via the one or more interconnects and separated by one or more bending interruptions, the one or more bending interruptions being configured and arranged to have a lower bending resistance than the first portion and the second portion to allow an orientation of the first partial plane to deflect from an orientation of the second partial plane at the one or more bending interruptions, and the first portion and the second portion directly electrically connecting via the one or more interconnects.

[0010] A highly formable flexible electrode is provided by disposing the flexible electrode on a surface of an elongated substrate and including one or more bending interruptions. In addition, portions on either side of the bending point are electrically connected by a low resistance interconnect, which allows for the mechanical bending and the electrical connection to be optimized separately. The one or more bending interruptions allow at least the electrode portion of the implantable device to conform to adjacent anatomical and tissue structures. This may also increase the tissue contact area of ​​the flexible electrode. The presence of the one or more interconnects allows for the bending characteristics to be optimized without substantially affecting the electrical characteristics of the flexible electrode. The flexible electrode may be configured and arranged as a return electrode or a stimulation electrode. Multiple flexible electrodes may be provided.

[0011] Additionally or alternatively, the compliant cross-sectional shape of the flexible electrode comprises one or more bending interruptions, the bending interruptions separating two portions having a higher stiffness than the bending interruption.

[0012] According to a further aspect of the present disclosure, there is provided an implantable stimulation device, wherein the flexible electrode has a longitudinal extent along a longitudinal axis, and the one or more bending interruptions are configured and arranged to permit bending about the longitudinal axis. Alternatively or additionally, the flexible electrode has a lateral extent along a first transverse axis, the transverse axis being generally perpendicular to the longitudinal axis, and the one or more bending interruptions are configured and arranged to permit bending about the transverse axis.

[0013] Bending about the longitudinal and / or transverse axes allows for highly formable implantable substrates, meaning substrate sections with electrodes (leads) that fit very closely to the surrounding tissue, and allows for the production of very precisely formable substrate sections for specific anatomical placements, or even individualized shaping for highly variable anatomical placements.

[0014] According to another aspect of the present disclosure, an implantable stimulation device is provided, wherein a tissue contacting surface of a first portion is disposed along a first partial plane and a tissue contacting surface of a second portion is disposed along a second partial plane.

[0015] If the substrate section is made highly formable, a high tissue contact surface can be provided, up to the entire surface area of ​​the flexible electrode portion, which means that the actual tissue stimulation area of ​​one or more electrodes can be more predictable.

[0016] According to yet another aspect of the present disclosure, the flexible electrode further comprises one or more continuous portions adjacent one or more bending interruptions configured and arranged to increase or maintain bending resistance between the first and second portions, which may be described as a deformable electrode that allows the electrode to bend into a desired shape and profile that may be retained in whole or in part.

[0017] This allows for separate optimization of electrical conductivity and bending resistance between the electrode portions. Configuring and arranging the continuous portion to increase or maintain bending resistance at the bending axis (e.g., making the continuous portion thinner and / or narrower) can be done without substantially affecting electrical conductivity and without substantially affecting the operation of the flexible electrode. If properly configured, the continuous portion also allows the substrate section to retain a bending profile, which can be advantageous when a medical professional prepares the substrate section for implantation.

[0018] According to yet another aspect of the present disclosure, the one or more bending interruptions comprise one or more gaps.

[0019] The gaps can be advantageous because they are relatively easy to create using lithography and etching techniques, and can provide a visual clue to the medical professional implanting the substrate section as to where the bending axis is located.

[0020] The features and advantages of certain embodiments of the present invention, and the manner in which they are accomplished, will become more readily apparent when the following detailed description of the invention is considered in conjunction with the accompanying drawings, which show preferred illustrative embodiments, and which are not necessarily drawn to scale. [Brief description of the drawings]

[0021] [Figure 1A] FIG. 1 illustrates a first example of an implantable distal end of a stimulation device. [Figure 1B]FIG. 2 is another diagram showing a first example of an implantable distal end of a stimulator device. [Figure 1C] FIG. 13 is yet another diagram illustrating a first example of an implantable distal end of a stimulator device. [Figure 2A] FIG. 1 illustrates a second example of an implantable distal end of a stimulator device. [Figure 2B] FIG. 13 is another diagram showing a second example of an implantable distal end of a stimulator device. [Figure 2C] FIG. 13 is yet another diagram illustrating a second example of an implantable distal end of a stimulator device. [Figure 3A] FIG. 13 illustrates a third example of an implantable distal end of a stimulator device. [Figure 3B] FIG. 13 is another diagram showing a third example of an implantable distal end of a stimulator device. [Figure 3C] FIG. 13 is yet another diagram illustrating a third example of an implantable distal end of a stimulator device. [Figure 4A] FIG. 13 illustrates a fourth example of an implantable distal end of a stimulation device. [Figure 4B] FIG. 13 illustrates a fifth example of an implantable distal end of a stimulation device. [Diagram 5] FIG. 1 illustrates examples of nerves that can be stimulated to treat headaches. [Figure 6] FIG. 1 illustrates an example of another nerve that can be stimulated to treat headaches. [Figure 7] FIG. 1 illustrates examples of nerves that may be stimulated for other treatments. [Figure 8] FIG. 2 illustrates a first surface of an implantable distal end of a stimulator device. [Figure 9] 13A-13C show examples of how devices can be configured and arranged to conform to a predetermined curvature. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] In the following detailed description, numerous non-limiting specific details are given to facilitate an understanding of the present disclosure.

[0023] In Figs. 1A, 1B and 1C, An elongated substrate 300 having a first surface 310 and a second surface 320 disposed along generally parallel transverse planes 600, 700 disposed along a longitudinal axis 600. 1 shows a longitudinal section through a first embodiment 100 of an implantable distal end of a stimulator device, comprising: a first surface 310 and a second surface 320 that are aligned along generally parallel transverse planes 600, 700 for a substrate 300 having a degree of flexibility, the extent to which the first surface 310 and the second surface 320 are aligned along generally parallel transverse planes 600, 700 can be determined by placing the substrate 300 generally on a plane. As shown, the first surface 310 is in a plane that includes a longitudinal axis 600 and a first transverse axis 700, which is generally perpendicular to the longitudinal axis 600. As shown, the plane of the first surface 310 is generally perpendicular to the plane of the cross-sectional view (generally perpendicular to the plane of the paper). The substrate 300 has a thickness or extent along a second transverse axis 750 that is generally perpendicular to both the longitudinal axis 600 and the first transverse axis 700, and is in the plane of the drawing (along the plane of the paper) as shown. The first surface 310 is designated as the top surface and the second surface 320 is designated as the bottom surface.

[0024] To clarify the different figures, the axes are given nominal directions: A longitudinal axis 600 extends from a proximal end (not shown) on the left side of the page to a distal end shown on the right side of the page. A first horizontal axis 700 extends into the page as shown. A second horizontal axis 750 extends from bottom to top as shown.

[0025] For example, the elongated substrate 300 may have an elastomeric distal end constructed from silicone rubber or another biocompatible, durable polymer, such as siloxane polymers, polydimethylsiloxane, polyurethane, polyetherurethane, polyetherurethaneurea, polyesterurethane, polyamide, polycarbonate, polyester, polypropylene, polyethylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, polysulfone, cellulose acetate, polymethylmethacrylate, polyethylene, and polyvinyl acetate. Examples of suitable polymers (including LCP liquid crystal polymers) are described in "Polymers for Neural Implants", Hassler, Boretius, Stieglitz, Journal of Polymer Science: Part B Polymer Physics, 2011, 49, 18-33 (DOI 10.1002 / polb.22169). In particular, Table 1 is included herein by reference and shows the properties of polyimide (UBE U-Varnish-S), Parylene C (PCS Parylene C), PDMS (NuSil MED-1000), SU-8 (MicroChem SU-8 2000&3000 Series), and LCP (Vectra MT1300).

[0026] Flexible substrates 300 are also preferred because they follow the contours of underlying anatomical features more closely. Very thin substrates 300 have the added advantage that they are much more flexible.

[0027] Preferably, the flexible substrate 300 comprises LCP, parylene and / or polyimide. LCP is a chemically and biologically stable thermoplastic polymer that enables small, airtight sensor modules with low moisture penetration.

[0028] Advantageously, the LCP may be thermoformed, allowing complex shapes to be provided. Very thin and very flat sections of LCP may be provided. A suitable laser may also be used for cutting, to fine-tune the shape. For example, an LCP substrate 300 may be used with a thickness (range along the second transverse axis 750) in the range of 50 microns (μm) to 720 microns (μm), preferably in the range of 100 microns (μm) to 300 microns (μm). For example, values ​​of 150 μm (microns), 100 μm, 50 μm, or 25 μm may be provided. Similarly, substrate widths (range along the first transverse axis 700) of 2 mm to 20 mm may be provided, for example, using LCP.

[0029] At room temperature, LCP thin films have mechanical properties similar to steel. This is important because the implantable substrate 300 must be strong enough to be implanted, strong enough to be removed (explanted), and strong enough to follow any movements of adjacent anatomical features and / or structures.

[0030] LCPs are among the polymeric materials with the lowest gas and water permeability. They can bond to themselves, allowing for multilayer constructions with homogeneous structure.

[0031] In contrast to LCP, polyimide is a thermosetting polymer that requires adhesives for the construction of multilayer boards. Polyimide is a thermosetting polymer material that is durable at high temperatures and flexure.

[0032] LCP can be used, for example, to provide a substrate with multiple layers (not shown), in other words, multiple layers of 25 μm (microns) thickness. Electrical interconnects and / or interconnect layers can also be provided by metallization using techniques from the PCB (printed circuit board) industry, such as metallization with biocompatible metals such as gold or platinum. Electroplating can be used. These electrical interconnects and / or interconnect layers can be used to provide electrical energy to any of the electrodes.

[0033] Preferably, a low aspect ratio is used for the elongated substrate to reduce the likelihood of implantation problems, e.g., a ratio of height (thickness or extent along the second horizontal axis 750) to width (extent along the first horizontal axis 700) of less than 10, such as 0.3 mm height and 10 mm width.

[0034] The device 101 in FIG. A flexible electrode 400 included on the first surface 310 and configured for contact with human or animal tissue in use. The flexible electrode 400 further comprises two or more portions 400a, 400b (400ab) separated by one or more bending interruptions 500. The flexible electrode 400 is configured as a return electrode 400.

[0035] By "contained" in the first surface or the second surface, it is meant that the flexible electrode 400 is relatively thin and is attached to the first surface 310 or the second surface 320. The electrode 400 may also be embedded in the first surface 310 or the second surface 320.

[0036] The first portion 400a and the second portion 400b are disposed on either side of the one or more bend interruptions 500. In some cases, the portions may be opposite each other, as shown in FIG. 1. With respect to the present disclosure, there is no substantial functional difference between the "a" portion and the "b" portion, and they may be interchanged. The conductive material disposed between two or more bend interruptions 500 may comprise one or more "a" portions and one or more "b" portions.

[0037] Because portions 400ab are directly electrically connected, they are considered to be included in the same electrode (portions of the same electrode); in other words, portions 400ab are connected such that the stimulation energy applied by a stimulation system (not shown) is substantially the same (typically measured as voltage, current, power, or any combination thereof) at substantially the same instance of time in each portion 400ab of the flexible return electrode 400.

[0038] This is not the same as two adjacent electrodes, which are constructed and arranged to provide substantially different energies at substantially the same time and / or to provide substantially the same energy at substantially different times. In the context of this disclosure, electrodes that have separate electrical connections to a source of electrical energy are considered "adjacent," i.e., they are not considered to be part of the same electrode.

[0039] The device 101 in FIG. One or more bending interruptions 500 between two portions 400ab of the flexible electrode 400, configured and arranged to allow deformation of the flexible return electrode 400 by bending at the location of the one or more bending interruptions 500. In other words, when the first portion 400a is disposed along a first partial plane and the second portion 400b is disposed along a second partial plane, the one or more bend interruptions 500 between the two portions 400ab are constructed and arranged to deflect away from the orientation of the second partial plane at the one or more bend interruptions 500.

[0040] The device 101 in FIG. One or more interconnects 450 constructed and arranged to directly electrically connect two or more of the portions 400ab. In addition, the one or more interconnects 450 may be configured to provide electrical energy from a stimulation system (not shown) to the flexible return electrode 400. The one or more interconnects 450 are disposed between the first surface 310 and the second surface 320. The interconnects 450 may comprise one or more conductors, such as, for example, metals formed as one or more conductive wires, strands, foils, laminae, plates, and / or sheets, as desired. The interconnects 450 may be substantially continuous (one conductor). The interconnects 450 may also include multiple conductors configured and arranged to be electrically connected to each other in use adjacent the corresponding bending breaks 500, in other words, the one or more conductors configured and arranged to be substantially electrically continuous in use.

[0041] Interconnects 450 in the context of the present disclosure are not configured or arranged to contact human or animal tissue in use, for example, by embedding one or more interconnects 450 in a low conductance or insulating substrate 300, such as LCP. Note that interconnects 450 may be included on first surface 310 or second surface 320 if they are configured and arranged to be low conductance and / or insulating by including one or more layers between interconnects 450 and any human or animal tissue.

[0042] By "included in" the first surface 310 or the second surface 320, it is meant that the interconnect 450 is relatively thin and is attached to the first surface 310 or the second surface 320. The interconnect 450 may also be embedded in the first surface 310 or the second surface 320.

[0043] Additionally or alternatively, the substrate 300 may be a multilayer including one or more electrical interconnects and / or electrical interconnect layers 450. If an LCP multilayer is used, the thickness (extent of the substrate 300 along the second transverse axis 750, or the vertical distance between the first surface 310 and the second surface 320) may typically be about 150 μm (microns) in sections without electrode portions 400ab or interconnects 450, about 250 μm in sections with electrodes 220, and about 180 μm in sections with electrical interconnects 250. If a multilayer is used, for example, one or more electrical interconnect layers that are 25 μm (microns) thick may be used.

[0044] Alternatively, the flexible return electrode 400 may be included on the second surface 320. The device may include multiple flexible return electrodes 400 included on the first surface 310 and / or the second surface 320.

[0045] In this example, the flexible electrode 400 is configured as a return electrode and is configured, in use, to provide an electrical return to one or more of the stimulation electrodes 220. In other words, the electrical return 400 closes an electrical circuit. The flexible electrode 400 may similarly be configured to provide an electrical ground to a corresponding source of electrical energy.

[0046] The device 101 in FIG. one or more stimulation electrodes 200 included on the second surface 320 and configured, in use, to transmit energy to human or animal tissue (after implantation); one or more electrical interconnects 250 configured to provide electrical energy from a stimulation system (not shown) to the one or more stimulation electrodes 200; The flexible electrode 400 is configured, in use, to provide an electrical return to the one or more stimulation electrodes 220.

[0047] By "contained in the second surface" it is meant that one or more stimulation electrodes 200 are relatively thin and are attached to the second surface 320. The electrodes 200 may also be embedded in the second surface 320.

[0048] Additionally or alternatively, the device may include one or more stimulation electrodes 200 included on the first surface 310 .

[0049] Typically, one or more stimulating electrodes 200 may be provided. The number, size, and / or spacing of the stimulating electrodes 200 may be selected and optimized depending on the treatment, for example, if multiple electrodes 200 are provided, each electrode 200 may provide a separate stimulating effect, a similar stimulating effect, or one or two electrodes 200 may be selected in close proximity to the tissue to which the effect is to be produced. If stimulation over a large area is required and / or the location between the active electrodes 200, more than one stimulating electrode 200 may be active. The electrodes 200 may comprise conductive materials such as gold, silver, platinum, iridium, and / or platinum / iridium alloys and / or oxides. An implantable device with a distal end (or lead) suitable for implantation may comprise, for example, 12 stimulating electrodes over a length of 15 cm. The stimulating electrodes may extend along the longitudinal axis 600 by approximately 6-8 mm, along the first transverse axis 700 by approximately 3-5 mm, and thus approximately 18-40 square mm (mm 2 ). 2 If a strip of width 4 mm (extent along the first transverse axis 700) is provided as the return electrode, then a strip of length (extent along the longitudinal axis 600) of 4.5 to 10 mm would also have dimensions of 18 to 40 square mm (mm 2 ) contact area. The electric field is more concentrated between the strip and the corresponding stimulation electrode.

[0050] FIG. 1B shows a view of the second surface 320 of the implantable end of the stimulator 100 shown in FIG. 1A. In other words, the second surface 320 is shown in the plane of the paper, lying along the longitudinal axis 600 (shown from bottom to top) and on the first horizontal axis 700 (shown from left to right). The second horizontal axis 750 runs into the page. This is the view facing the animal or human tissue to be stimulated (in use). The first surface 310, not shown in FIG. 1B, is higher (into the page) along the second horizontal axis 750 and is also generally parallel to the plane of the drawing.

[0051] As shown in Figure 1A, one or more interconnects 250 are disposed between the second surface 320 and the first surface 310. In Figure 1B, they are shown as dotted lines, representing wire (or wire-like) interconnects 250 provided on each of the stimulation electrodes 200 in this example.

[0052] The substrate 300 extends along a first lateral axis 700 (considered to be the width of the stimulator 100) from a first lateral extent 330 (shown on the left side) to a second lateral extent 340 (shown on the right side).

[0053] The device 100 may be implanted by first creating a tunnel and / or using an implantation tool.

[0054] Return electrode 400 is shown in Figures 1A and 1B, but not in Figure 1C.

[0055] 1B, the stimulating electrodes 200 have a longitudinal extent along a longitudinal axis 600 and a lateral extent along a first lateral axis 700. Although shown as similar, in reality each stimulating electrode 200 may differ in shape, cross-section, and size (or extent).

[0056] FIG 1C shows a view of the first surface 310 of the implantable distal end of device 100 shown in FIG 1A and FIG 1B. In other words, the first surface 310 is shown in the plane of the paper lying along the longitudinal axis 600 (shown from bottom to top) and on a first transverse axis 700 (shown from right to left). A second transverse axis 750 extends off the page. The second surface 320, not shown in FIG 1C, is at a lower position (into the page) along the second transverse axis 750 and is also generally parallel to the plane of the drawing.

[0057] As shown in Figure 1A, one or more interconnects 450 are disposed between first surface 310 and second surface 320. Not shown in Figure 1C are interconnects 450, which are included in an interconnect layer 450 immediately below first surface 310, with through connections (not shown) to each portion 400ab in this example.

[0058] It may be advantageous to manufacture this first embodiment 100 such that the longitudinal extents 600 of the flexible electrode 400 portions 400ab are substantially similar, thereby providing similar bending flexibility in multiple longitudinal 600 configurations.

[0059] After implantation of the device 100, in use, an energy source may be constructed and arranged to provide electrical energy to the stimulation electrode 200 for electrical return applied to each portion 400ab of the corresponding return electrode 400. Because the portions of the return electrode 400 are directly electrically connected to each other, the applied electrical return is substantially the same for all points along the return electrode portion 400ab.

[0060] It is advantageous to provide one or more return electrodes 400 in close proximity to the corresponding one or more stimulating electrodes 200, as this may allow a more focused electric field to be used. It may be advantageous to configure and arrange the one or more proximate return electrodes to be located within less than 8 mm, preferably less than 6 mm, of the corresponding one or more (active) stimulating electrodes. However, if modifications are made to one or more stimulating electrodes 200 used for stimulation, it may not be possible to configure an electrode proximate to the modified stimulating electrode 200 as an electrical return.

[0061] Providing multiple selectable return electrodes 400 may increase the complexity of the implantable stimulator device and / or require a more complex control system. An alternative is to provide a ground electrode 400 with increased longitudinal 600 and lateral 700 extent compared to conventional devices, but this may increase the stiffness (increase bending resistance) of the corresponding section of the substrate due to the metal layer.

[0062] Thicker metal layers are generally preferred over thinner metal layers for electrodes 200, 400 due to potential exposure to bodily substances that can dissolve metal, although thicker metal layers typically result in increased stiffness.

[0063] A further design factor is to give preference to providing a combined active tissue contact area of ​​one or more return electrodes 400 that is equal to or greater than the active tissue contact area of ​​one or more active stimulating electrodes 200. The contact area to be considered is not the total contact surface area, but the contact area that is configured to be active during use, and the contact area that actually contacts the surrounding tissue. In general, the ratio between the tissue contact areas does not need to be strictly determined, but they should be of the same order of magnitude. For example, it may be sufficient if the combined active tissue contact area of ​​one or more return electrodes is 70%-100% or more of the active tissue contact area of ​​one or more stimulating electrodes.

[0064] The provision of one or more bending interruptions 500 may enhance the ability of the distal end of the stimulator to conform to the shape and anatomical features of the surrounding tissue, thereby optimizing the tissue contact area. In the example shown in Figure 1, one return electrode 400 is provided, and the optimized contact area is up to a maximum of the total contact area of ​​the two or more electrode segments 400ab.

[0065] 1C, the one or more bend interruptions 500 have a lateral extent 700 that corresponds to the lateral extent of the substrate 300 (i.e., from edge 340 to edge 330). The bend interruptions 500 are disposed substantially along a first lateral axis 700 and generally perpendicular to the longitudinal axis 600.

[0066] In configuring and positioning the one or more bending interruptions 500, several parameters and characteristics may be considered, such as: The orientation of the required curvature, in this example, substantially around a multiple of the longitudinal arrangement 600. This can be influenced, for example, by the orientation of one or more bending interruptions 50 and the separation between the first portion 400a and the second portion 400b. The maximum radius of curvature of the substrate 300 in this longitudinal configuration 600. This can be influenced, for example, by the separation between the first portion 400a and the second portion 400b, and the bending resistance between the first portion 400a and the second portion 400b.

[0067] The bending resistance between the first portion 400a and the second portion 400b depends on parameters such as: The lateral extent 700 and / or longitudinal extent 600 of one or more interruptions The thickness of the substrate 300 or the distance between the first surface 310 and the second surface 320 The materials included in the substrate 300 in the region of the one or more interruptions, and their physical properties. The bending resistance of the substrate 300 material may be increased by including different materials of different thicknesses and different stiffness and / or elasticity, such as reinforcing fibers, metal wires, and / or LCP strips. The presence of interconnects 250 , 450 and / or interconnect layer 450 between the first surface 310 and the second surface 320 . The presence of one or more reinforcing coatings, such as a sputtered layer of chromium. The presence of one or more depressions in the first surface 310 and / or the second surface 320. The presence of one or more electrodes 200, 400 in a longitudinal 600 and / or transverse 700 arrangement at one or more interruptions 500. For example, the stimulation electrode 200 shown in FIG. 1A is longitudinally 600 arranged at the interruptions between the first and second portions 400a, 400b, which may increase bending resistance at these interruptions.

[0068] As shown in Figures 1A and 1C, the spacing between portions 400ab of the flexible return electrode 400 is approximately the same, but one skilled in the art will appreciate that each bending interruption may be configured and positioned differently to provide one or more predetermined bending resistances.

[0069] One of the insights on which an embodiment of the present invention is based is that the inherent flexibility of some substrate materials offers the advantage of a high degree of conformity with the shape of the surrounding tissue. However, the presence of one or more electrodes 200, 400 can affect the flexibility, resulting in sections of the substrate that are stiff adjacent to more flexible sections. Areas of the electrode surface can be thinned, thickened, or removed to provide an optimal bending profile, but this can affect the electrical properties of the electrode by affecting the degree to which different portions of the electrode surface area remain substantially continuous.

[0070] 2A, 2B and 2C show longitudinal sections through a second embodiment 101 of an implantable distal end of a stimulation device, which is similar to the first embodiment 100 shown in FIG. 1, with the following differences: Instead of one or more separate stimulation electrodes 200, a further flexible electrode 200 is provided which is included on the second surface 320 and configured to contact human or animal tissue in use. This flexible stimulation electrode 200 comprises two or more portions 400a, 400b (400ab) separated by one or more bending interruptions 500. The portions 200ab of the flexible stimulation electrode 200 are disposed in substantially the same longitudinal orientation 600 as the portions 400ab of the flexible return electrode 400. In other words, the bending interruptions 500 of the flexible stimulation electrode 200 are disposed in substantially the same longitudinal orientation 600 as the bending interruptions 500 of the flexible return electrode 400. The one or more interconnects 450 for the return electrode portions 400ab are still electrical interconnect layer 450. However, they are located further away from the first surface 310 (in other words, closer to the second surface 320). In this case, the return electrical interconnect layer 450 includes conductors that connect to each portion 400ab. As previously mentioned, these conductors are substantially electrically continuous in use. The one or more electrical interconnects 250 for the stimulation electrodes 200, implemented as wires in Fig. 1, are now replaced by one or more interconnects 250 included in a further electrical interconnect layer 250. In this case, the interconnects 250 are located further away from the second surface 320 (in other words, closer to the first surface 310). In this case, the stimulation electrical interconnect layer 250 includes conductors connecting to each of the portions 200ab. As previously mentioned, these conductors are substantially electrically continuous in use.

[0071] By aligning the longitudinal positions 600 of the bend points 500 included in the first surface 310 and the second surface 320, a highly flexible substrate is provided 300 with high uniformity in bending resistance due to the interruptions being substantially identically configured and positioned.

[0072] Alternatively, the flexible stimulation electrode 200 may also be included on the first surface 310. The device may include multiple flexible stimulation electrodes 200 included on the first surface 310 and / or the second surface 320.

[0073] Although the electrodes included on the top surface 310 are shown as one or more return electrodes 400 and the electrodes included on the bottom surface 320 are shown as stimulating electrodes 200, one skilled in the art will appreciate that the function of the electrodes 200, 400 may be altered by changing the electrical connections to the distal ends. This may be advantageous when it is uncertain whether the implantable distal end is above or below the target tissue, for example, above or below a nerve.

[0074] 3A, 3B and 3C show longitudinal sections through a third embodiment 102 of the implantable distal end of a stimulation device, which is similar to the second embodiment 101 shown in FIG. 2, with the following differences: Instead of the flexible stimulation electrode 200 being included on the second surface 320, the flexible stimulation electrode 200 is included on the first surface 310. The second surface 320 does not include any electrodes. Portion 400ab of flexible return electrode 400 and portion 200ab of flexible stimulation electrode 200 are included on first surface 310 and are interleaved (interleaved). The one or more interconnects 450 for the return electrode portions 400ab are implemented as wires or wire-like (as shown by dashed lines in FIG. 3B) in this example. In this case, the interconnects 450 are included on the second surface 320 and include conductors that penetrate substantially the entire thickness of the substrate 300 to connect to each portion 400ab. In this case, the context of the one or more return interconnects 450 of the present disclosure is not configured or arranged to contact human or animal tissue in use. For example, the return interconnects 450 are made low conductance and / or insulating by including one or more layers (not shown) between the interconnects 450 and any human or animal tissue. One or more interconnects 250 for the stimulating electrode portions 200ab are implemented in this case as wires or wire-like (as shown in FIG. 3B ), in which case the interconnects 450 are included between the first surface 310 and the second surface 320 and include conductors that extend through substantially the entire thickness of the substrate 300 to connect to each portion 400ab.

[0075] An advantage of this embodiment is that the local electric field strength may be increased due to the lower separation between the stimulating electrode portion 200ab and the return portion 400ab.

[0076] Alternatively, the flexible stimulation electrode 200 and the return flexible electrode 400 may be included on the second surface 320. The device may include multiple flexible stimulation electrodes 200 included on the first surface 310 and / or the second surface 320.

[0077] For clarity, the continuous portion 470 is not shown, but the bend point 500 may be of any of the configurations described above with respect to Figures 4A and 4B.

[0078] 4A and 4B show a fourth example 103 and a fifth example 104 of an implantable distal end of a stimulator device, in each case a view of a first surface 310 of the implantable distal end of these devices. These are modifications of the return electrode 400 shown in FIG. 1C or 2C. FIG. 4A and 4B also show a flexible electrode 400 having a longitudinal extent along a longitudinal axis 600 and a lateral extent along a first transverse axis 700, the transverse axis 700 being generally perpendicular to the longitudinal axis 600. The flexible electrode 400 generally includes one or more bending interruptions 500.

[0079] 4A shows a flexible return electrode 400 with multiple section pairs separated by four different configurations of specific bending interruptions 371, 372, 373, 374. Three of them 371, 373, 374 provide bending about generally lateral bending axes 771, 773, 774. One of the bending interruptions 372 provides bending about a bending axis 772 at an angle to the first lateral axis 700, in other words allowing bending in a diagonal direction.

[0080] FIG. 4B illustrates a flexible return electrode 400 with one pair of sections separated by a bending interruption 375 constructed and arranged to allow bending generally about the longitudinal axis 600 of the substrate.

[0081] 4A and 4B includes one or more bending interruptions 371, 372, 373, 374, 375 that are configured and arranged to allow the orientation of a corresponding first partial plane to deflect from the orientation of a corresponding second partial plane at one or more bending interruptions 371, 372, 373, 374, 375, in other words, to allow bending about a corresponding bending axis 771, 772, 773, 774, 600. However, in these cases, each of the bending interruptions 371, 372, 373, 374, 375 provides a different possible deflection and / or bending resistance.

[0082] 4A shows a first bending interruption 371 disposed generally along a first transverse axis 700. The first bending interruption 371 is disposed along the first bending axis 771 to provide a first bending point 771, which is a region of increased flexibility compared to an immediately adjacent portion of the electrode 400. This may be achieved by providing regions of change in relevant parameters as discussed above, for example, regions of substantially thinner electrode, regions without electrode material (gaps), and / or regions including different electrode materials and / or coatings. Because the first bend interruption 371 is disposed generally along the first transverse axis 700, the first bend interruption 371 is configured and arranged to allow a first partial plane of the first surface 310 between the first bend interruption 371 and the distal end (more positive along the longitudinal axis 600) to deflect from a second partial plane of the first surface 310 between the first bend interruption 371 and the proximal end (more negative along the longitudinal axis 600). With appropriate configuration, the substrate 300 may be allowed to bend away from the first surface 310 and / or away from the second surface 320.

[0083] Optionally, the first bending interruption 371 may include one or more gaps, in other words, the flexible electrode 400 is no longer continuous at this point and the bending is primarily determined by the properties of the substrate. Gaps may be advantageous because they are relatively easy to create and may provide a visual clue to the medical professional implanting the substrate section as to where the bending axis will be located.

[0084] In addition, it may be advantageous to provide a further connection between adjacent portions separated by one or more interruptions 371, the further connection comprising one or more continuous portions proximate to one or more bending interruptions 371, where one continuous portion 470 is shown between a lateral edge of the interruption 371 and the edge 340 of the substrate 300.

[0085] Similar to the configurations described above, electrical connections between the portions are provided via one or more interconnects 450 disposed between the first surface 310 and the second surface 320 .

[0086] The continuous portion 470 forms part of the electrode conductive layer and may therefore be considered an additional electrical connection, although the continuous portion 470 may therefore be substantially configured to increase or maintain bending resistance at the bending axis, such that any effect on electrical conductivity (e.g., by making the continuous portion 470 thinner and / or narrower) does not substantially affect the operation of the flexible electrode 400.

[0087] One insight on which an embodiment of the present invention is based is that the shape of the conductive electrode material can be configured and arranged to maintain or increase bending resistance at the bending axis. One or more regions of the electrode proximate the bending interruption can be thinned, thickened, or shaped to provide a predetermined bending resistance using the region of the electrode that remains continuous. The presence of interconnects allows for a very high degree of bending resistance configuration potential while affecting the electrical properties of the flexible electrode 200, 400.

[0088] The one or more bending interruptions 371 and / or the gap or gaps may be formed using any suitable material removal (or part removal) technique, such as lithography, chemical etching, using a laser, using a mechanical scribe, and any combination thereof, and thus it is easy to provide relatively complex shapes.

[0089] Additionally or alternatively, a similar configuration and arrangement may be achieved by increasing the amount of material present adjacent the first bend interruption 371, for example, using a coating and / or ridge made of the substrate material 300.

[0090] One skilled in the art will appreciate that the degree of bend, direction of bend, and placement can be provided by appropriate placement and configuration of one or more bend interruptions 371, and optional one or more gaps. For example, one skilled in the art can predetermine the degree of bend by configuring the length (longitudinal extent 600), width (lateral extent 700), and shape. The shapes can include, for example, rectangular, square, trapezoidal, polygonal, etc.

[0091] 4A further shows a second bending interruption 372 disposed at approximately 20 degrees relative to the first transverse axis 700. This is similar to the first bending interruption 371, with the following exceptions: The second bending interruption 372 is disposed along a second bending axis 772 that is at an angle of approximately 20 degrees relative to the first transverse axis 700 and approximately 70 degrees relative to the longitudinal axis 600 .

[0092] Similarly, adjacent continuous portions 470 are provided to increase or maintain bending resistance.

[0093] Any angle may be used to provide a corresponding angle of the bending axis / point 772 .

[0094] 4A further illustrates a third bend interruption 373 disposed along a third bend axis 773 also generally along the first transverse axis 700. This is similar to the first bend interruption 372, with the following exceptions: An additional continuous portion 470 is provided between the edge 330 of the substrate 300 and the lateral edge of the interruption 373 .

[0095] Either continuous portion 470 may be constructed and arranged to increase or maintain bending resistance.

[0096] 4A further illustrates a fourth bend point with three interruptions 374 disposed along a fourth bending axis 774 also generally along the first transverse axis 700. This is similar to the third bend interruption 373, with the following exceptions: three bending interruptions 374, each having less than one-third the lateral extent of the third bending interruption 373; It has four successive portions 470 .

[0097] Either continuous portion 470 may be constructed and arranged to increase or maintain bending resistance.

[0098] FIG. 4B illustrates a fifth example 104 of an implantable distal end of a stimulator device.

[0099] The fifth example 104 includes a fifth bend point with two interruptions 375 disposed generally along the longitudinal axis 600. The interruptions 375 are similar to the bend interruptions described above in connection with FIG.

[0100] In this case, the continuation portion 470 is disposed adjacent to and between two bending interruptions 375 disposed generally along the longitudinal axis 600 .

[0101] The continuous portion 470 may be constructed and arranged to increase or maintain bending resistance.

[0102] One skilled in the art will appreciate that any number of interruptions and any number of continuous portions may be provided to provide the desired resistance to bending, the desired degree of flexibility, and the desired angle. This allows the substrate 300 to conform to adjacent anatomical tissue, i.e., if it is sufficiently flexible and has a low degree of resistance to bending, the substrate 300 may conform by being pressed against adjacent tissue at the point of implantation. Additionally or alternatively, it may be slightly less flexible to allow a medical professional to bend the substrate into an appropriate conforming shape prior to and / or during implantation.

[0103] In addition, multiple interruptions may be provided at different angles to allow for different shapes of electrode portions. For example, one or more electrode portions 200ab, 400ab may be provided separated by one or more interruptions to provide a substrate 300 that bends in more than one direction. The electrode portions may be, for example, polygonal, rectangular, square, trapezoidal in shape.

[0104] Alternatively or additionally, such bending interruptions 371, 372, 373, 374, 375 may be included in a flexible stimulation electrode 200 included in the first surface 310. Alternatively or additionally, one or more bending interruptions 371, 372, 373, 374, 375 may be included in a flexible electrode 200, 400 included in the second surface 320.

[0105] An example of how a device may be constructed and arranged to conform to a predetermined curvature is shown in Figure 9. Substrate 300 is shown in longitudinal cross-section elongated along longitudinal axis 600. Longitudinal axis 600 is shown at the desired curvature. Substrate 300 has a first surface 310 and a second surface 320 arranged along generally parallel curved transverse sections 600, 700.

[0106] As shown, the first surface 310 lies in a plane that includes the longitudinal axis 600 and the first transverse axis 700, which is generally perpendicular to the longitudinal axis 600. As shown, the curvatures of the first surface 310 and the second surface 320 are generally perpendicular to the plane of the cross-sectional view (generally perpendicular to the plane of the paper). The substrate 300 has a thickness or extent D along a second transverse axis 750, which is generally perpendicular to both the longitudinal axis 600 and the first transverse axis 700, and which is in the plane of the view (along the plane of the paper) as shown.

[0107] A flexible electrode 200, 400 is provided separated into four portions 200ab, 400ab included in the curved second surface 320. This may be any of the stimulating and / or return electrodes described above. The electrode 200, 400 includes three bending interruptions 500 providing three bending points / axes (not shown) generally along a first transverse axis 700. For clarity, the continuous portion 470 is not shown, but the bending points 500 may be of any of the configurations described above with respect to Figures 4A and 4B.

[0108] As shown, the nominal curvature of the substrate 300 is R1, from the center point of curvature to a central plane that is midway between the first surface 310 and the second surface 320 along the second horizontal axis 750. The conforming curvature of the substrate 300 is R2, from the center point of curvature to the curved second surface 320. The thickness of the electrode (extent along the second horizontal axis 750) is labeled as L. The thickness of the substrate 300 (extent along the second horizontal axis 750) is labeled as D. W2 is the pitch between the segments. W1 is the longitudinal extent 600 of the electrode segments.

[0109] The standard values ​​are: R1: 100mm D / L: 0.150mm L: 0.050mm

[0110] The calculation is as follows for standard values: R2=R1-(D / 2+L) W2 / W1=2πR2 / 2πR1=R2 / R1 R2 / R1=(R1-(D / 2+L)) / R1=1-(D / 2+L) / R1 For these standard values, W2 / W1 = 0.998 or 99.8%.

[0111] Thus, by providing bending interruptions 500 with an extent of 1.2% along the longitudinal axis compared to electrode portions 200ab, 400ab, substrate 300 constitutes a sufficiently flexible substrate where the device can be bent to conform to a radius of curvature of 100mm or less. The smaller the radius of curvature, the higher the degree of bending.

[0112] Typically, the curvature that the implantable distal end of the stimulator device must conform to can be determined by measurements of the patient.

[0113] Additionally or alternatively, a database such as the DINED database of body measurements (from 2004) may be used to determine normative values. The dimensions of these 3D human models are based on anthropometric data from a survey conducted in the Netherlands in 2004. P50 refers to the percentile of the people who participated in the survey: For frontal implants, the curvature of the male P50 since 2004 is a horizontal radius of 75.124 mm and a vertical radius of 96.615 mm. For frontal implants, the curvature of the female P50 after 2004 is a horizontal radius of 771.089 mm and a vertical radius of 93.108 mm. For occital implants, the curvature of the male P50 since 2004 is a horizontal radius of 74.916 mm and a vertical radius of 96.095 mm. For occital implants, the curvature of the female P50 after 2004 is a horizontal radius of 70.641 mm and a vertical radius of 91.42 mm. Thus, with appropriate configuration, a radius of curvature of 90mm to 96mm can be provided.

[0114] The dimensions of these 3D human models are based on anthropometric data from a survey carried out in the Netherlands in 2004. P50 refers to the percentile of the people who participated in the survey. For both the frontal and occipital regions, the radius of the most curved edge is defined by the osculating circle: For male P50, the radius of the frontal contact circle is 63.019 mm; For male P50, the radius of the occipital contact circle is 60.458 mm; For female P50, the radius of the frontal contact circle was 58.195 mm; For female P50, the radius of the occipital contact circle was 56.228 mm; Thus, with appropriate configuration, a radius of curvature between 55mm and 65mm can be provided.

[0115] The dimensions of these 3D human models are based on anthropometric data from a survey carried out in the Netherlands in 2004. P5 and P95 refer to the percentiles of the people who participated in the survey, with P5 representing the smallest person in the entire sample and P95 the largest:

[0116] At both the front and back of the head, the radius of the most curved edge is defined by an osculating circle. For male P95, the horizontal radius is 79.00 mm, the vertical radius is 100.477 mm, and the radius of the frontal contact circle is 67.361 mm. For male P95, the horizontal radius was 79.423 mm, the vertical radius was 102.003 mm, and the radius of the occipital contact circle was 66.237 mm. For female P5, the horizontal radius is 64.68 mm, the vertical radius is 83.336 mm, and the radius of the frontal contact circle is 49.585 mm. In female P5, the horizontal radius was 65.578 mm, the vertical radius was 85.21 mm, and the occipital osculating circle radius was 48.035 mm. Thus, with appropriate configuration, a radius of curvature between 45mm and 80mm can be provided.

[0117] FIG. 8 shows a view of a first surface 310 of a sixth example 105 of an implantable distal end of a stimulator device.

[0118] This is a variation of the flexible return electrode 400 shown in Figure 4A. Figure 8 also shows a flexible electrode 400 having a longitudinal extent along a longitudinal axis 600 and a lateral extent along a first transverse axis 700, which is generally perpendicular to the longitudinal axis 600. The flexible electrode 400 generally includes one or more bending interruptions 500.

[0119] FIG. 8 differs from FIG. 4A in the following ways: The flexible electrode 400 comprises a plurality of electrode portions 400ab separated by six bending interruptions 371 (as shown in FIG. 4A ) and configured and arranged to provide substantially the same bending characteristics and substantially the same bending resistance between each portion 400ab about a plurality of bending axes 771, which in this case are approximately the same as the first transverse axis 700. The substantially same configured and arranged interruptions 771 provide a highly uniform bending resistance.

[0120] 5 and 6 show examples of nerves that may be stimulated using appropriately configured implantable distal ends of stimulators 100, 101, 102, 103, 104, 105, 106, 107 to provide neurostimulation for treating, for example, headaches or primary headaches.

[0121] Figure 5 shows the left supraorbital nerve 910 and the right supraorbital nerve 920, which may be electrically stimulated using a suitably configured device. Figure 6 shows the left greater occipital nerve 930 and the right greater occipital nerve 940, which may also be electrically stimulated using a suitably configured device.

[0122] Depending on the size of the area to be stimulated and the dimensions of the portion of the device to be implanted, a suitable location is determined to provide the electrical stimulation required for the treatment. The approximate implant locations of the distal portions of the stimulators constituting stimulators 100, 101, 102, 103, 104, 105, 106, 107 are shown as areas: Position 810 for left supraorbital stimulation and position 820 for right supraorbital stimulation to treat chronic headaches such as migraines and cluster headaches. Position 830 for left occipital stimulation and position 840 for right occipital stimulation to treat chronic headaches such as migraines, cluster headaches, and occipital neuralgia.

[0123] In many cases, these will be the approximate locations 810, 820, 830, 840 of the implantable devices 100, 101, 102, 103, 104, 105, 106, 107.

[0124] A separate stimulation system may be used for each implant location 810, 820, 830, 840. If the implant locations 810, 820, 830, 840 are adjacent to one another or overlap, a single stimulation system may be configured to stimulate at multiple implant locations 810, 820, 830, 840.

[0125] The multiple stimulators 100, 101, 102, 103, 104, 105, 106, 107 may be operated separately, simultaneously, sequentially, or any combination thereof to provide the required therapy.

[0126] Figure 7 shows further examples of nerves that may be stimulated using appropriately configured improved implantable devices 100, 101, 102, 103, 104, 105, 106, 107 to provide neurostimulation to treat other conditions. Also shown in Figure 7 are the locations (810, 820, 830, 840) shown in Figures 5 and 6.

[0127] Depending on the size of the area to be stimulated and the dimensions of the portion of the device to be implanted, a suitable location is determined to provide the electrical stimulation required for the treatment. The approximate implant locations of the portions of the stimulator that constitute the stimulation electrodes are shown as areas: Location of cortical stimulation to treat epilepsy 810; Deep brain stimulation position 850 for tremor suppression treatment in Parkinson's patients, dystonia, obesity, essential tremor, depression, epilepsy, obsessive-compulsive disorder, Alzheimer's disease, anxiety, bulimia, tinnitus, traumatic brain injury, Tourette's, sleep disorders, autism, bipolar disorder treatment, and stroke recovery, 860 Position of vagus nerve stimulation to treat epilepsy, depression, anxiety, binge eating, obesity, tinnitus, obsessive-compulsive disorder, and heart failure; Location of carotid artery or carotid sinus stimulation to treat hypertension 860, Location of hypoglossal and phrenic nerve stimulation to treat sleep apnea 860, Position 865 for cerebrospinal stimulation to treat chronic neck pain, Peripheral nerve stimulation locations for treating limb pain, migraine, and peripheral pain 870, 875 Positions for Spinal Cord Stimulation to Treat Chronic Back Pain, Angina, Asthma, Pain in General, Gastric stimulation position 880 for the treatment of obesity, bulimia, interstitial cystitis, Location of sacral and pudendal nerve stimulation for the treatment of interstitial cystitis 885, Location of sacral nerve stimulation for the treatment of urinary incontinence, fecal incontinence 885, Location of sacral neuromodulation for bladder control therapy 890, as well as Location of Peroneal Nerve Stimulation to Treat Gait or Foot Drop895.

[0128] Other conditions that may be treated include gastroesophageal reflux disease and inflammatory diseases.

[0129] The description herein should not be understood as prescribing a set order for performing the method steps described therein. Rather, the method steps may be performed in any order that is feasible. Similarly, the examples are used to explain the algorithms and are not intended to represent the only implementations of these algorithms; one skilled in the art will be able to devise many different ways to achieve the same functionality provided by the embodiments described herein.

[0130] Many types of implantable distal ends of the stimulator device are shown, however, this does not exclude the remainder of the device from being implanted, which should be interpreted to mean that at least the electrode section of the distal end is preferably constructed and arranged to be implanted.

[0131] In general, in any of the configurations described and illustrated in this disclosure, any electrode 200, 400 may be connected as either a stimulating electrode 200 or a return electrode 400. This may be advantageous when there is uncertainty as to whether the implantable distal end is above or below the target tissue, for example, above or below a nerve.

[0132] This can be advantageous when it is uncertain whether the implantable distal end is above or below the target tissue, for example above or below a nerve.

[0133] Although the present invention has been described in connection with specific exemplary embodiments, it should be understood that various changes, substitutions, and alterations apparent to those skilled in the art could be made to the disclosed embodiments without departing from the spirit and scope of the invention as set forth in the appended claims. [Explanation of symbols]

[0134] 100 First implantable distal end of stimulator 101 a second implantable distal end of the stimulator 102 a third implantable distal end of the stimulator 103 Fourth implantable distal end of stimulator 104 Fifth implantable distal end of stimulator 105 sixth implantable distal end of stimulator 106 a first implantable distal end of the stimulator 200 One or more stimulation electrodes 200ab one or more stimulation electrode parts 250 Electrical interconnection of one or more stimuli 300 Long and thin board 310 first substantially planar lateral surface 320 second substantially planar lateral surface 371 First bending interruption 372 Second bending interruption 373 Third bending interruption 374 Fourth bend interruption 375 Fifth bending break 400 One or more return electrodes 400ab One or more return electrode segments 450 One or more return electrical interconnections 470 One or more continuous parts 500 Bending Interruption 600 Longitudinal axis 700 First horizontal axis 750 Second horizontal axis 771 First bending axis / point 772 Second bending axis / point 773 Third bending axis / point 774 4th bending axis / point 810 Location of left supraorbital nerve or cortical stimulation 820 Right supraorbital stimulation position 830 Position of left occipital nerve stimulation 840 Right occipital nerve stimulation position 850 Deep Brain Stimulation Location 860 Location of vagus nerve, carotid artery, carotid sinus, phrenic nerve or sublingual stimulation 865 Position of Cerebrospinal Stimulation 870 Peripheral Nerve Stimulation Location 875 Spinal Cord Stimulation Location 880 Location of Gastric Stimulation 885 Location of Sacral and Pudendal Nerve Stimulation 890 Location of Sacral Nerve Modulation 895 Peroneal Nerve Stimulation Location 910 Left supraorbital nerve 920 Right supraorbital nerve 930 Left greater occipital nerve 940 Right greater occipital nerve

Claims

1. An implantable stimulation device (100, 101, 102, 103, 104, 105, 106, 107), comprising: The present invention relates to an elongated substrate (300) disposed along a longitudinal axis (600) having first and second surfaces (310) and (320) that are substantially parallel to one another and disposed along a plane that includes the longitudinal axis (600) and a first transverse axis (700) perpendicular to the longitudinal axis, the elongated substrate (300) comprising: a flexible electrode (200, 400) included on said first surface (310) or said second surface (320) and configured for contacting human or animal tissue in use; one or more interconnects (250, 450) disposed between said first surface (310) and said second surface (320); The flexible electrode (200, 400) further comprises: a first portion (200ab, 400ab) disposed along a first surface; a second portion (200ab, 400ab) disposed along the second surface; wherein the first portion and the second portion are in direct electrical communication via the one or more interconnects (250, 450) and are separated by one or more bending interruptions (500, 371, 372, 373, 374, 375); the one or more bending interruptions are constructed and arranged to have a lower bending resistance than the first and second portions to allow the first surface to deflect from the second surface at the one or more bending interruptions (500, 371, 372, 373, 374); the flexible electrode (200, 220) comprising one or more continuous portions (470) proximate the one or more bending interruptions (500, 371, 372, 373, 374, 375) configured and arranged to increase or maintain the bending resistance between the first and second portions (200ab, 400ab) relative to the bending interruptions, the continuous portions forming part of an electrode conductive layer and electrically connecting electrode portions downstream and upstream of the bending interruptions along the longitudinal axis. An implantable stimulator (100, 101, 102, 103, 104, 105, 106, 107).

2. the conformable cross-sectional shape of the flexible electrode (200, 400) comprises one or more bending interruptions (500, 371, 372, 373, 374, 375), the bending interruptions separating two portions having a higher stiffness than the bending interruptions; 10. The implantable stimulator device of claim 1.

3. the flexible electrode (200, 400) has a longitudinal extent along the longitudinal axis (600); the one or more bending interruptions (500, 375) are constructed and arranged to permit bowing about the longitudinal axis (600); 3. An implantable stimulator according to claim 1 or 2.

4. the flexible electrode (200, 400) has a lateral extent along a first lateral axis (700) that is generally perpendicular to the longitudinal axis (600); the one or more bending interruptions (500, 371, 372, 373, 374, 375) are constructed and arranged to permit deflection about a transverse axis (700, 771, 772, 773, 774); 3. An implantable stimulator according to claim 1 or 2.

5. a tissue contacting surface of the first portion (200ab, 400ab) disposed along the first surface; The tissue contact surface of the second portion (200ab, 400ab) is disposed along the second surface. An implantable stimulator according to any one of claims 1 to 4.

6. The implantable stimulation device of any one of claims 1 to 5, wherein the one or more bending interruptions (500, 371, 372, 373, 374, 375) comprise one or more gaps.

7. The implantable stimulation device of any one of claims 1 to 6, wherein the flexible electrode (200) is configured and arranged as a stimulation electrode (200) configured and arranged to provide stimulation energy to human or animal tissue.

8. The implantable stimulator device of any one of claims 1 to 6, wherein the flexible electrode is configured and arranged as a return electrode (400).

9. 9. The implantable stimulation device of claim 8, wherein the device (100, 101, 102, 103, 104) further comprises one or more stimulation electrodes (200), and the return electrode (400) is configured to provide electrical return to a corresponding one or more stimulation electrodes (200) in use.

10. 10. The implantable stimulation device of claim 9, wherein the one or more stimulation electrodes (200) are included on the second surface (320) and the return electrode (400) is included on the second surface (310).

11. 10. The implantable stimulation device of claim 9, wherein the one or more stimulation electrodes (200) and the return electrode (400) are included on the first surface (310) or the second surface (320).

12. 12. The implantable stimulation device of claim 1, wherein the substrate further comprises one or more additional interconnects (250) disposed between the first surface (310) and the second surface (320), the one or more additional interconnects (250) configured and arranged to provide stimulation energy to one or more electrodes (200, 400).

13. The substrate (300) Liquid crystal polymers (LCP), polyimides, parylenes, biocompatible polymers, biocompatible elastomers, and any combinations of the above. The implantable stimulator device of any one of claims 1 to 12, comprising:

14. An implantable stimulator (100) according to any one of claims 1 to 13, a source of electrical energy constructed and arranged, in use, to provide energy to said flexible electrodes (200, 400); A stimulation system comprising:

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