Implantable electrical stimulation device with flexible electrodes

Abstract

Mismatching the curvature of the electrode lead portion may produce unexpected and / or unpredictable resistance to the underlying tissue. In addition, repeated movement of the relevant area of ​​the body may even exacerbate the mismatch. Implants for electrical stimulation require low-resistance conductors for the stimulation electrodes, return electrodes, and interconnects, which typically use metal for the wires and contacts. These conductors reduce flexibility, and the problem becomes more severe as the number of electrodes increases due to the desire to provide a higher degree of customization. An implantable stimulation device is provided with an elongated substrate (300), one or more interconnects (250, 450), a flexible electrode (200, 400) having two parts separated by one or more bend interruptions (500, 371, 372, 373, 374, 375), wherein the first part and the second part are directly electrically connected via the one or more interconnects (250, 450). The electrode parts on opposite sides of the bend point are electrically connected, thereby allowing optimization of mechanical bending and electrical connection respectively.

Description

Technical Field

[0001] The present disclosure relates to an implantable stimulation device comprising flexible electrodes for providing electrical stimulation. The present disclosure also relates to a stimulation system comprising such an implantable stimulation device. Background Art

[0002] Implantable electrical stimulation systems can be used to deliver electrical stimulation therapy to a patient to treat various symptoms or conditions, such as headaches, low back pain, and incontinence.

[0003] In many electrical stimulation applications, it is desired to provide electrical stimulation to one or more precise locations within the body by means of a stimulation device which typically includes a treatment lead (the lead including electrodes and electrical connections) - in many cases, precise alignment of the stimulation electrodes during implantation can be difficult due to curvature of tissue and anatomical structures. A mismatch in the curvature of the electrode portion of the lead can create unexpected and / or unpredictable resistance between one or more electrodes and the underlying tissue. In addition, repeated movement of the relevant area of ​​the body can even exacerbate the mismatch. A particular problem with subcutaneous implants is that even small differences in flexibility between the implant and the surrounding tissue can affect the patient's comfort and can cause irritation to the overlying skin.

[0004] Recently, polymers with inherent flexibility have been used. However, implants for electrical stimulation require low-resistance conductors for the stimulation electrodes, return electrodes, and interconnects, which typically use metal for leads and contacts. These conductors reduce flexibility, and the problem becomes more severe as electrode size increases, driven by the desire to provide a higher degree of customization, increase functionality, or reduce resistance.

[0005] US Patent Application No. 2015 / 099959 describes an implantable electrode array comprising an organic substrate material configured to be implanted in an in vivo environment and optionally dissolve and be absorbed, 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 comprising a flexible support element having a head end and a tail end for at least one conductive element. The conductive element has at least one head contact and at least one tail contact, arranged at the head end and the tail end, respectively, of the flexible support element, such that the conductive element transmits a signal from the head contact to the tail contact and vice versa. Furthermore, the conductive element comprises a conductive track formed by a layer of conductive ink deposited on the flexible support element.

[0007] US application US 2018 / 0008821 describes a thin film device and methods for its manufacture and implantation. In one embodiment, a shaped insulator is formed to have an inner surface, an outer surface, and a contour shaped according to the selected dielectric application. A conductive trace layer is manufactured on the inner surface of the shaped insulator using biocompatible metallization. An insulating layer is applied over the conductive trace layer. An electrode array and a connection array are manufactured on the outer surface of the shaped insulator and / or the insulating layer, and the electrode array and the connection array are electrically connected to the conductive trace layer to form a flexible circuit. The implantable thin film device is formed of a flexible circuit according to the selected dielectric application.

[0008] It is an object of the present invention to provide an improved implantable stimulation device having multiple conductors that provides a higher degree of conformity with the surrounding tissue and anatomical structures. Summary of the Invention

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

[0010] A highly configurable flexible electrode is provided by providing it on the surface of an elongated substrate and including one or more bending interruptions. In addition, the portions on opposite sides of the bending point are electrically connected via low-resistance interconnects, which allows optimization of mechanical bending and electrical connection, respectively. One or more bending interruptions allow at least the electrode portion of the implantable device to conform to adjacent anatomical structures and tissue structures. This can also increase the tissue contact area of ​​the flexible electrode. The presence of one or more interconnects allows optimization of the bending characteristics without substantially affecting the electrical properties of the flexible electrode. The flexible electrode can be configured and arranged as a return electrode or a stimulation electrode. Multiple flexible electrodes can be provided.

[0011] Additionally or alternatively, the compliant shape of the flexible electrode in cross-section includes one or more bend discontinuities separating two portions having a higher stiffness than the bend discontinuity.

[0012] According to another aspect of the present disclosure, an implantable stimulation device is provided, wherein the flexible electrode has a longitudinal extent along a longitudinal axis; and the one or more bend interruptions are configured and arranged to allow deviation about the longitudinal axis. Alternatively or additionally, the flexible electrode has a lateral extent along a first transverse axis that is substantially perpendicular to the longitudinal axis; and the one or more bend interruptions are configured and arranged to allow deviation about the transverse axis.

[0013] Curvature around the longitudinal and / or transverse axis allows for a highly configurable implantable substrate. This means that the substrate portion with the electrodes (leads) conforms very closely to the surrounding tissue. Curvature around the longitudinal and / or transverse axis also allows for very precisely shaped substrate portions for specific anatomical arrangements and even personalized shaping for highly variable anatomical arrangements.

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

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

[0016] According to another aspect of the present disclosure, the flexible electrode further comprises one or more abutments adjacent to the one or more bend interruptions, the one or more abutments being configured and arranged to increase or maintain resistance to bending between the first portion and the second portion. This can be described as a deformable electrode, allowing it to be bent into a desired shape and contour that can be fully or partially maintained.

[0017] This allows for the electrical conductivity and bending resistance between the electrode portions to be optimized separately. Configuring and arranging the abutment to increase or maintain bending resistance at the bending axis (e.g., making the abutment thinner and / or narrower) can be performed without substantially affecting electrical conductivity and without substantially affecting the operation of the flexible electrode. The abutment, when properly configured, also allows the substrate portion to maintain a curved profile—which can be advantageous when a healthcare professional is preparing the substrate portion for implantation.

[0018] According to yet another aspect of the present disclosure, the one or more bend interruptions include one or more openings.

[0019] The openings may be advantageous because they are relatively simple to create using photolithography and etching techniques, and they may also provide a visual clue to the healthcare professional that the portion of the substrate in which the curved shaft is disposed is being implanted. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Features and advantages of some embodiments of the present invention and the manner in which they are achieved will become more apparent upon consideration of the following detailed description of the invention taken in conjunction with the accompanying drawings, which illustrate preferred and exemplary embodiments and which are not necessarily drawn to scale, and in which:

[0021] Figure 1A 、 Figure 1B and Figure 1C A first example of an implantable distal end of a stimulation device is depicted;

[0022] Figure 2A 、 Figure 2B and Figure 2C depicts a second example of an implantable distal end of a stimulation device;

[0023] Figure 3A 、 Figure 3B and Figure 3C depicts a third example of an implantable distal end of a stimulation device;

[0024] Figure 4A and Figure 4B depicting fourth and fifth examples of implantable distal ends of stimulation devices;

[0025] Figure 5 and Figure 6 depicts examples of nerves that can be stimulated to treat headaches;

[0026] Figure 7 depicts examples of nerves that can be stimulated for other treatments;

[0027] Figure 8 depicting a view of a first surface of an implantable distal end of a stimulation device; and

[0028] Figure 9 An example of configuring and arranging a device to conform to a predetermined curvature is depicted. DETAILED DESCRIPTION

[0029] In the following detailed description, numerous non-limiting specific details are set forth to facilitate understanding of the present disclosure.

[0030] Figure 1A 、 Figure 1B and Figure 1C Depicted is a longitudinal section through a first embodiment 100 of an implantable distal end of a stimulation device comprising:

[0031] An elongated substrate 300 is arranged along a longitudinal axis 600, the substrate having a first surface 310 and a second surface 320 arranged along substantially parallel transverse planes 600, 700. For substrates 300 having a degree of flexibility, the degree to which the first and second surfaces 310, 320 lie along substantially parallel transverse planes 600, 700 can be determined by placing the substrate 300 on a substantially flat surface. As depicted, the first surface 310 lies in a plane including the longitudinal axis 600 and a first transverse axis 700, with the first transverse axis 700 being substantially perpendicular to the longitudinal axis 600. As depicted, the plane of the first surface 310 is substantially perpendicular to the plane of the cross-sectional view (substantially perpendicular to the surface of the paper). The substrate 300 has a thickness or extent along a second transverse axis 750, which is substantially perpendicular to both the longitudinal axis 600 and the first transverse axis 700, and as depicted, the second transverse axis 750 lies in the plane of the drawing (along the surface of the paper). The first surface 310 is depicted as an upper surface, and the second surface 320 is depicted as a lower surface.

[0032] To clarify the different views, the axes are assigned nominal directions:

[0033] - a longitudinal axis 600 extending from a proximal end (not depicted) on the left side of the page to a distal end depicted on the right side of the page;

[0034] - As depicted, a first horizontal axis 700 extends into the page; and

[0035] - As depicted, the second transverse axis 750 extends from bottom to top.

[0036] For example, the elongated substrate 300 may include an elastomeric distal end composed of silicone rubber or another biocompatible, durable polymer such as a silicone polymer, polydimethylsiloxane, polyurethane, polyetherurethane, polyetherurethane urea, polyesterurethane, polyamide, polycarbonate, polyester, polypropylene, polyethylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, polysulfone, cellulose acetate, polymethyl methacrylate, polyethylene, and polyvinyl acetate. Suitable examples of polymers including LCPs (liquid crystal polymers) are described in the following reference: Hassler, Boretius, Stieglitz, "Polymers for Neural Implants," Journal of Polymer Science: Series B Polymer Physics, 2011, 49, 18-33 (DOI 10.1002 / polb.22169). In particular, Table 1 is included herein for reference, which depicts the properties of polyimide (UBE U-Varnish-S), polyparaxylene C (PCS Parylene C), PDMS (NuSil MED-1000), SU-8 (MicroChem SU-8 2000 & 3000 series), and LCP (Vectra MT1300).

[0037] Flexible substrates 300 are also preferred because they follow the contours of the underlying anatomical features very closely.Very thin substrates 300 have the additional advantage that they have increased flexibility.

[0038] Preferably, the flexible substrate 300 comprises LCP, parylene and / or polyimide. LCP is a chemically and biologically stable thermoplastic polymer that allows for a sealed sensor module with small size and low moisture permeation.

[0039] Advantageously, LCP can be thermoformed, thereby allowing complex shapes to be provided. Very thin and very flat LCP parts can be provided. In order to fine-tune the shape, suitable lasers can also be used for cutting. For example, an LCP substrate 300 with a thickness (along the scope of the second horizontal axis 750) in the range of 50 microns (um) to 720 microns (um) can be used, and preferably, a thickness (along the scope of the second horizontal axis 750) in the range of 100 microns (um) to 300 microns (um) can be used. For example, a value of 150um (micrometer), 100um, 50um or 25um can be provided. Similarly, for example, a substrate width of 2mm to 20mm (along the scope of the first horizontal axis 700) can be provided using LCP.

[0040] At room temperature, thin LCP films have mechanical properties similar to steel. This is important because implantable substrate 300 must be strong enough to be implanted, strong enough to be removed (implanted), and strong enough to follow any movement of adjacent anatomical features and / or structures.

[0041] LCPs are polymer materials with minimal permeability to gases and water. LCPs can bond to themselves, allowing for multi-layer builds with a uniform structure.

[0042] Compared to LCP, polyimide is a thermosetting polymer that requires adhesives for the construction of multi-layer substrates. Polyimide is a thermosetting polymer material with high temperature and bending durability.

[0043] For example, LCP can be used to provide a substrate having multiple layers (not depicted) - in other words, LCP can be used to provide a substrate having several layers with a thickness of 25 μm (micrometer). Electrical interconnects and / or interconnect layers can also be provided by metallization using techniques from the PCB (printed circuit board) industry, for example, using 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 electrode.

[0044] Preferably, a low aspect ratio is used for the elongated substrate to reduce the chance of implantation problems - for example a ratio of height (thickness or extent along the second horizontal axis 750) to width (extent along the first horizontal axis 700) less than 10, for example 0.3 mm high and 10 mm wide.

[0045] The apparatus 101 of FIG. 1 further includes:

[0046] A flexible electrode 400 is included in the first surface 310 and is configured to contact human or animal tissue in use. The flexible electrode 400 comprises two or more portions 400a, 400b (400ab) separated by one or more curved interruptions 500. The flexible electrode 400 is configured as a return electrode 400.

[0047] “Included in” the first surface or the second surface means 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.

[0048] The first portion 400a and the second portion 400b are arranged on opposite sides of one or more interruptions 500. In some cases, the first portion 400a and the second portion 400b can be opposite each other, as depicted in FIG1. ​​For purposes of this disclosure, there is no substantial functional difference between the "a" portion and the "b" portion - they can be interchanged. The conductor material arranged between two or more curved interruptions 500 can include one or more "a" portions and one or more "b" portions.

[0049] Portions 400ab are considered to be included in the same electrode (portions of the same electrode) because they are directly electrically connected - in other words, portions 400ab are connected so that the stimulation energy applied by a stimulation system (not shown) in each portion 400ab of the flexible return electrode 400 is substantially the same (typically measured as voltage, current, power, or any combination thereof) at substantially the same time.

[0050] This is different from two adjacent electrodes. Adjacent electrodes are configured 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" - these electrodes are not considered to be part of the same electrode.

[0051] The apparatus 101 of FIG. 1 further includes:

[0052] One or more bend interruptions 500 between the two portions 400ab of the flexible electrode 400, configured and arranged to allow the flexible return electrode 400 to deform by bending at the locations where the one or more bend interruptions 500 are arranged. In other words, if the first portion 400a is arranged along a first partial plane and the second portion 400b is arranged along a second partial plane, the one or more bend interruptions 500 between the two portions 400ab are configured and arranged to deviate from the orientation of the second partial plane at the one or more bend interruptions 500.

[0053] The apparatus 101 of FIG. 1 further includes:

[0054] - One or more interconnects 450, which are configured and arranged to directly electrically connect two or more parts 400ab. In addition, the one or more interconnects 450 can be configured to provide electrical energy from a stimulation system (not depicted) to the flexible return electrode 400. The one or more interconnects 450 are arranged between the first surface 310 and the second surface 320. The one or more interconnects 450 may include one or more conductors such as metals, for example, formed with one or more of the following conductors: wire, strand, foil, sheet, plate and / or sheet, as needed. They can be substantially continuous (one conductor). The one or more interconnects 450 may also include more than one conductor, which are configured and arranged to be electrically connected to each other near the corresponding bend interruption 500 during use - in other words, the one or more conductors are configured and arranged to be substantially electrically continuous during use.

[0055] In the context of the present disclosure, the interconnects 450 are not configured or arranged to contact human or animal tissue during use. For example, by embedding one or more interconnects 450 in a low-conductivity or insulating substrate 300, such as an LCP. Note that if the interconnects 450 are configured and arranged to be low-conductivity and / or insulating by including one or more layers between the interconnects 450 and any human or animal tissue, then the interconnects 450 can be included in the first surface 310 or the second surface 320.

[0056] Being “included” in the first surface 310 or the second surface 320 means that the interconnect 450 is relatively thin and 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.

[0057] Additionally or alternatively, substrate 300 may be multilayered, including one or more electrical interconnects and / or electrical interconnect layers 450. If an LCP multilayer is used, the thickness (the extent of substrate 300 along second transverse axis 750 or the vertical distance between first surface 310 and second surface 320) may be typically about 150 μm (micrometers) in portions without electrode portions 400 ab or interconnects 450, and may be typically about 250 μm in portions with electrodes 220, and may be typically about 180 μm in portions with electrical interconnects 250. If multilayered, for example, one or more electrical interconnect layers having a thickness of 25 μm (micrometers) may be used.

[0058] Alternatively, the flexible return electrode 400 may also be included in the second surface 320. The device may include a plurality of flexible return electrodes 400 included in the first surface 310 and / or the second surface 320.

[0059] In this example, the flexible electrode 400 is configured as a return electrode—the return electrode is configured to provide an electrical return for one or more stimulation electrodes 220 in use. In other words, the electrical return 400 closes the circuit. The electrical return 400 can also be similarly configured to provide an electrical ground for a corresponding source of electrical energy.

[0060] The apparatus 101 of FIG. 1 further includes:

[0061] - One or more stimulation electrodes 200 comprised in the second surface 320 and configured to transmit energy to human or animal tissue in use (following implantation).

[0062] - One or more electrical interconnects 250 configured to provide electrical energy from a stimulation system (not depicted) to the one or more stimulation electrodes 200. The flexible electrode 400 is configured to provide an electrical return for these one or more stimulation electrodes 220 in use.

[0063] “Included in the second surface” means that the one or more stimulation electrodes 200 are relatively thin and attached to the second surface 320. The electrodes 200 may also be embedded in the second surface 320.

[0064] Additionally or alternatively, the device may include one or more stimulation electrodes 200 included in the first surface 310 .

[0065] Typically, one or more stimulation electrodes 200 may be provided. The number, size and / or spacing of the stimulation electrodes 200 may be selected and optimized depending on the treatment - for example, if more than one electrode 200 is provided, each electrode 200 may provide a separate stimulation effect, and a similar stimulation effect or selection may be performed by one or two electrodes 200 closer to the tissue where the effect is to be produced. If stimulation is required over a larger area and / or at an arrangement between active electrodes 200, two or more stimulation electrodes 200 may be made effective. The electrodes 200 may comprise a conductive material, such as gold, silver, platinum, iridium and / or a platinum / iridium alloy and / or oxide. An implantable device having a distal end (or lead) suitable for implantation may comprise, for example, 12 stimulation electrodes of 15 cm in length. The stimulation electrodes may have a size of approximately 6 mm to 8 mm along the longitudinal axis 600 and approximately 3 mm to 5 mm along the first transverse axis 700, thus approximately 18 square millimeters (mm 2 ) to 40 square millimeters (mm 2 If a strip of 4 mm width (range along the first horizontal axis 700) is provided as a return electrode, a length of 4.5 mm to 10 mm (range along the vertical axis 600) also provides 18 square millimeters (mm 2 ) to 40 square millimeters (mm 2) contact area. The electric field is more concentrated between the strip and the corresponding stimulation electrode.

[0066] Figure 1B Depicts Figure 1A 1. A view of the second surface 320 of the implantable end of the stimulation device 100 is depicted in FIG. In other words, the second surface 320 is depicted in the plane of the paper along a longitudinal axis 600 (depicted from bottom to top) and a first transverse axis 700 (depicted from left to right). A second transverse axis 750 extends into the page. This is a view toward the animal or human tissue being stimulated (in use). Figure 1B , but the first surface 310 is located at a higher position along the second transverse axis 750 (into the page), and the first surface 310 is also substantially parallel to the plane of the drawing.

[0067] like Figure 1A As depicted, one or more interconnects 250 are disposed between the second surface 320 and the first surface 310. Figure 1B , one or more interconnects 250 are depicted as dashed lines, representing in this example a wire (or wire-like) interconnect 250 provided for each of the stimulation electrodes 200 .

[0068] The substrate 300 extends along a first transverse axis 700 (considering the width of the stimulation device 100 ) from a first lateral extent 330 (depicted on the left-hand side) to a second lateral extent 340 (depicted on the right-hand side).

[0069] The device 100 may be implanted by first creating a tunnel and / or using an implantation tool.

[0070] The return electrode 400 is Figure 1A and Figure 1B is depicted in Figure 1C Not depicted.

[0071] like Figure 1B As depicted, the stimulation electrodes 200 have a longitudinal extent along a longitudinal axis 600 and a lateral extent along a first lateral axis 700. Although depicted as similar, in reality, each stimulation electrode 200 may vary in shape, cross-section, and size (or extent).

[0072] Figure 1C Depicts Figure 1A and Figure 1B 1. A view of the first surface 310 of the implantable distal end of the device 100 depicted in FIG. In other words, the first surface 310 is depicted in the plane of the paper along a longitudinal axis 600 (depicted from bottom to top) and a first transverse axis 700 (depicted from right to left). The second transverse axis 750 extends off the page. Figure 1C, but the second surface 320 is located at a lower position along the second transverse axis 750 (into the page), and the second surface 320 is also substantially parallel to the plane of the drawing.

[0073] like Figure 1A As depicted, one or more interconnects 450 are disposed between the first surface 310 and the second surface 320. Figure 1C , one or more interconnects 450 are not depicted—one or more interconnects 450 are included in the interconnect layer 450 directly below the first surface 310, in which example the one or more interconnects 450 have a through connection (not depicted) to each of the portions 400ab.

[0074] It may be convenient to manufacture this first embodiment 100 such that the longitudinal extent 600 of the flexible electrode 400 portions 400ab are substantially similar - this providing a similar degree of bending flexibility at the various longitudinal 600 arrangements.

[0075] After implantation of the device 100, the source of energy may be configured and arranged to, in use, provide electrical energy to the stimulation electrode 200 relative to the electrical return applied to each portion 400ab of the corresponding return electrode 400. Because the portions of the return electrode 400 are each directly electrically connected, the applied electrical return is substantially the same for all points along the return electrode portion 400ab.

[0076] Providing one or more return electrodes 400 near the corresponding one or more stimulation electrodes 200 is advantageous because it can allow the use of a more concentrated electric field. It may be advantageous to configure and arrange the one or more proximal return electrodes to be located within a range of less than 8 mm, preferably less than 6 mm, from the one or more corresponding (active) stimulation electrodes. However, when the one or more stimulation electrodes 200 used for stimulation are changed, it may not be possible to configure an electrode near the changed stimulation electrode 200 as an electrical return.

[0077] If multiple optional return electrodes 400 are provided, the complexity of the implantable stimulation device may increase and / or require a more complex control system. An alternative is to provide a ground electrode 400 with an increased longitudinal 600 and lateral 700 extent compared to conventional devices - however, due to the metal layer, this may increase the rigidity of the corresponding part of the substrate (increase resistance to bending).

[0078] Thicker metal layers are generally preferred over thinner metal layers for electrodes 200, 400 because they may be affected by body matter that can dissolve the metal. However, thicker metal layers generally increase rigidity.

[0079] An additional design factor is the preference to provide a combined effective tissue contact area of ​​the one or more return electrodes 400 that is equal to or greater than the effective tissue contact area of ​​the one or more active stimulation electrodes 200. The contact area to consider is not the total contact surface area, but rather the contact area that is configured to be effective during use and the contact area that is actually in contact with the surrounding tissue. Generally, the ratios between the tissue contact areas do not need to be determined precisely—they should be of similar order of magnitude. For example, it may be sufficient if the combined effective tissue contact area of ​​the one or more return electrodes is equal to or greater than 70% to 100% of the effective tissue contact area of ​​the one or more stimulation electrodes.

[0080] By providing one or more curved interruptions 500, the tissue contact area can be optimized due to the enhanced ability of the distal end of the stimulation device to conform to the shape of surrounding tissue and anatomical features. In the example depicted in FIG1 , a single return electrode 400 is provided, and the optimized contact area reaches a maximum value of the total contact area of ​​two or more electrode portions 400 ab.

[0081] like Figure 1C As depicted, one or more bend discontinuities 500 have a lateral extent 700 comparable to the lateral extent of substrate 300 (in other words, from edge 340 to edge 330). One or more bend discontinuities 500 are disposed substantially along a first lateral axis 700 and are disposed approximately perpendicular to longitudinal axis 600.

[0082] When configuring and arranging the one or more bend interruptions 500, a number of parameters and characteristics may be considered, such as:

[0083] - Desired curvature orientation - in this example, arranged substantially around a plurality of longitudinal directions 600. This may be influenced by, for example, the orientation of the one or more bend interruptions 50 and the spacing between the first portion 400a and the second portion 400b.

[0084] - the maximum radius of curvature of the substrate 300 at this longitudinal arrangement 600. This may be influenced by, for example, the spacing between the first portion 400a and the second portion 400b and the bending resistance between the first portion 400a and the second portion 400b.

[0085] The bending resistance between the first portion 400a and the second portion 400b depends on the following parameters:

[0086] - The transverse extent 700 and / or the longitudinal extent 600 of the one or more interruptions.

[0087] The thickness of the substrate 300 or the distance between the first surface 310 and the second surface 320 .

[0088] - The materials and their physical properties included in the area of ​​one or more discontinuities in the substrate 300. The bending resistance of the substrate 300 material can be increased by including different materials (e.g. reinforcing wires, metal wires and / or LCP strips) of different thicknesses and different stiffness and / or elasticity.

[0089] The presence of interconnects 250 , 450 and / or an interconnect layer 450 between the first surface 310 and the second surface 320 .

[0090] - The presence of one or more reinforcing coatings, for example a sputtered layer of chromium.

[0091] The presence of one or more indentations in the first surface 310 and / or the second surface 320 .

[0092] - the presence of one or more electrodes 200, 400 at the longitudinal 600 arrangement and / or transverse 700 arrangement of one or more interruptions 500. For example, Figure 1A The stimulation electrodes 200 depicted in FIG are arranged longitudinally 600 at the interruptions between the first portion 400a and the second portion 400b - this may increase the bending resistance at these interruptions.

[0093] like Figure 1A and Figure 1C As depicted, the spacing between portions 400ab of the flexible return electrode 400 is substantially the same, but skilled artisans will recognize that each bend interruption may be individually configured and arranged to provide one or more predetermined resistances to bending.

[0094] One of the insights underlying aspects of the present invention is that the inherent flexibility of some substrate materials offers the advantage of being highly conformable to the shape of surrounding tissue. However, the presence of one or more electrodes 200, 400 may affect flexibility, resulting in rigid portions of the substrate being adjacent to more flexible portions. Areas of the electrode surface may be thinned, thickened, or removed to provide an optimal bending profile, but this may affect the electrical properties of the electrode by affecting the extent to which different portions of the electrode surface area remain substantially continuous.

[0095] Figure 2A 、 Figure 2B and Figure 2C A longitudinal section through a second embodiment 101 of a stimulation device comprising an implantable distal end is depicted. The second embodiment 101 is similar to the first embodiment 100 depicted in FIG1 , except for the following:

[0096] Instead of one or more separate stimulation electrodes 200, a further flexible electrode 200 is provided, which is included in the second surface 320 and is configured to come into contact with human or animal tissue in use. The flexible stimulation electrode 200 comprises two or more parts 400a, 400b (400ab) separated by one or more curved interruptions 500.

[0097] Portion 200ab of flexible stimulation electrode 200 is disposed in substantially the same longitudinal 600 arrangement as portion 400ab of flexible return electrode 400. In other words, bend interruption 500 of flexible stimulation electrode 200 is disposed in substantially the same longitudinal 600 arrangement as bend interruption 500 of flexible return electrode 400.

[0098] The one or more interconnects 450 for the return electrode portion 400ab are still an electrical interconnect layer 450. However, the one or more interconnects 450 are positioned 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 connected to each portion 400ab. As previously described, these conductors are substantially electrically continuous during use.

[0099] The one or more electrical interconnects 250 for the stimulation electrodes 200, which are implemented as wires in FIG1 , are replaced here by one or more interconnects 250 included in a further electrical interconnect layer 250. In this case, the one or more electrical interconnects 250 are arranged 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 connected to each portion 200 ab. As previously described, these conductors are substantially electrically continuous during use.

[0100] By aligning the longitudinal direction 600 positions of the bending points 500 included in the first surface 310 and the second surface 320, a very flexible substrate 300 is provided that has a highly uniform bending resistance because the discontinuities are configured and arranged substantially identically.

[0101] Alternatively, the flexible stimulation electrode 200 may also be included in the first surface 310. The device may include a plurality of flexible stimulation electrodes 200 included in the first surface 310 and / or the second surface 320.

[0102] Although the electrodes included in the top surface 310 are indicated as one or more return electrodes 400, and the electrodes included in the bottom surface 320 are indicated as stimulation electrodes 200, a skilled artisan will recognize that the functionality of the electrodes 200, 400 can be modified by changing the electrical connections to the distal end. This can be advantageous if there is uncertainty as to whether the implantable distal end is above or below the target tissue, such as above or below a nerve.

[0103] Figure 3A 、 Figure 3B and Figure 3C A longitudinal section through the implantable distal end of a third embodiment 102 of a stimulation device is depicted. The third embodiment 102 is similar to the second embodiment 101 depicted in FIG2 except for the following:

[0104] Instead of the flexible stimulation electrodes 200 being included in the second surface 320, the flexible stimulation electrodes 200 are included in the first surface 310. The second surface 320 does not include electrodes.

[0105] - Portions 400ab of the flexible return electrode 400 and portions 200ab of the flexible stimulation electrode 200 are included in the first surface 310 and are alternated (interleaved).

[0106] - One or more interconnects 450 for the return electrode portion 400ab are implemented in this example as wires or wire-like (in Figure 3B ). In this case, the interconnect 450 is included in the second surface 320, and the interconnect 450 includes a conductor connected to each portion 400ab that passes through substantially the entire thickness of the substrate 300. In this case, the one or more return interconnects 450 in the context of the present disclosure are not configured or arranged to contact human or animal tissue during use. For example, the one or more return interconnects 450 exhibit low conductivity and / or insulation by including one or more layers (not depicted) between the interconnect 450 and any human or animal tissue.

[0107] - one or more interconnects 250 for the stimulation electrode portion 200ab are in this case realized as wires or wire-like (e.g. Figure 3B In this case, an interconnect 450 is included between the first surface 310 and the second surface 320 , the interconnect 450 including a conductor connected to each portion 400 ab passing through substantially the entire thickness of the substrate 300 .

[0108] An advantage of this embodiment may be the increased local field strength due to the low separation between the stimulation 200ab electrode portion and the return 400ab portion.

[0109] Alternatively, the flexible stimulation electrode 200 and the return flexible electrode 400 may be included in the second surface 320. The device may include a plurality of flexible stimulation electrodes 200 included in the first surface 310 and / or the second surface 320.

[0110] For clarity, the abutment 470 is not depicted, but the inflection point 500 may be the one described above with respect to Figure 4A and Figure 4B Any configuration described.

[0111] Figure 4A and Figure 4B A fourth example 103 and a fifth example 104 of an implantable distal end of a stimulation device are depicted—in both cases a view of a first surface 310 of the implantable distal end of these devices. Figure 4A and Figure 4B yes Figure 1C or Figure 2C A modification of the return electrode 400 depicted in . Figure 4A and Figure 4B Also depicted is a flexible electrode 400 having a longitudinal extent along a longitudinal axis 600 and a lateral extent along a first lateral axis 700, which is substantially perpendicular to the longitudinal axis 600. The flexible electrode 400 generally includes one or more bend discontinuities 500.

[0112] Figure 4A Depicted is a flexible return electrode 400 comprising multiple pairs of sections separated by four differently configured specific bend interruptions 371, 372, 373, 374. Three of these 371, 373, 374 provide for bending about generally transverse bend axes 771, 773, 774. One of the bend interruptions 372 provides for bending about a bend axis 772 that is at an angle to the first transverse axis 700—in other words, it allows for diagonally oriented bending.

[0113] Figure 4B Depicted is a flexible return electrode 400 comprising a pair of portions separated by a bend discontinuity 375 configured and arranged to permit bending about a generally longitudinal substrate axis 600 .

[0114] Figure 4A and Figure 4BEach bending point in the embodiment of the present invention includes one or more bend interruptions 371, 372, 373, 374, 375 that are configured and arranged to allow the orientation of each respective first partial plane to deviate from the orientation of each respective second partial plane at the one or more bend interruptions 371, 372, 373, 374, 375—in other words, the bend interruptions allow bending about the respective bending axis 771, 772, 773, 774, 600. However, in these cases, each of the bend interruptions 371, 372, 373, 374, 375 provides a different possible deviation and / or resistance to bending.

[0115] Figure 4A A first bend interruption 371 is depicted, generally arranged along a first transverse axis 700. The first bend interruption 371 is positioned along the first bend axis 771 to provide a first bend point 771—a region of increased flexibility of the interruption 371 compared to the immediately adjacent portion of the electrode 400. This can be achieved by providing regions with variations in relevant parameters, such as those noted above, such as regions of substantially thinner electrodes, regions without electrode material (openings), and / or regions comprising different electrode materials and / or coatings. Because the first bend interruption 371 is positioned generally along the first transverse axis 700, the first bend interruption 371 is configured and arranged to allow the plane of a first portion of the first surface 310 between the first bend interruption 371 and the distal end (more positive along the longitudinal axis 600) to deviate from the plane of a second portion of the first surface 310 between the first bend interruption 371 and the proximal end (more negative along the longitudinal axis 600). By appropriate configuration, the substrate 300 can be allowed to bend away from the first surface 310 and / or away from the second surface 320.

[0116] Optionally, the first bend interruption 371 may include one or more openings—in other words, the point at which the flexible electrode 400 ceases to be continuous and the bend is primarily determined by the properties of the substrate. Openings may be advantageous because they are relatively simple to create and they may also provide a visual cue to the medical professional implanting the portion of the substrate that defines the axis of bend.

[0117] Additionally, it may be advantageous to provide an additional connection between adjacent portions separated by one or more discontinuities 371—the additional connection comprising one or more adjacent portions near one or more curved discontinuities 371—here, an adjacent portion 470 is depicted between a lateral edge of the discontinuity 371 and an edge 340 of the substrate 300.

[0118] As in the above configuration, electrical connection between the portions is provided by one or more interconnects 450 disposed between the first surface 310 and the second surface 320 .

[0119] The abutment 470 forms part of the electrode's conductive layer and can therefore be considered an additional electrical connection. However, the abutment 470 can therefore be configured generally to increase or maintain bending resistance at the bending axis, and any effect on conductivity (e.g., due to making the abutment 470 thinner and / or narrower) does not substantially affect the operation of the flexible electrode 400.

[0120] One of the insights underlying aspects of the present invention 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 near the bend discontinuity can be thinned, thickened, or shaped to provide a predetermined bending resistance while maintaining a continuous region of the electrode. The presence of interconnects allows for a very high degree of configurability of the bending resistance that influences the electrical properties of the flexible electrodes 200, 400.

[0121] The one or more curved interruptions 371 and / or one or more openings may be formed using any suitable material removal (or partial removal) technique such as photolithography, chemical etching, using a laser, using mechanical scribing, and any combination thereof. Thus, providing relatively complex shapes is simple.

[0122] Additionally or alternatively, similar configurations and arrangements may be achieved by increasing the amount of material present near the first bend interruption 371 using, for example, a coating and / or ridges made from the substrate material 300 .

[0123] The skilled person will recognize that the degree of curvature, direction, and arrangement of the curvature can be provided by appropriate arrangement and configuration of the one or more curvature interruptions 371 and, optionally, the one or more openings. For example, the skilled person can predetermine the degree of curvature by configuring the length (longitudinal extent 600), width (lateral extent 700), and shape. For example, the shape can include geometric shapes such as rectangles, squares, trapezoids, and polygons.

[0124] Figure 4A Also depicted is a second bend interruption 372 disposed approximately 20 degrees from the first transverse axis 700. The second bend interruption 372 is similar to the first bend interruption 371 except for the following:

[0125] The second bending interruption 372 is arranged along a second bending axis 772 which makes an angle of approximately 20 degrees with the first transverse axis 700 and an angle of approximately 70 degrees with the longitudinal axis 600 .

[0126] Similarly, a nearby abutment 470 is provided to increase or maintain resistance to bending.

[0127] Any angle may be used to provide a corresponding angle for the bending axis / point 772 .

[0128] Figure 4A Also depicted is a third bend interruption 373 disposed along a third bend axis 773, which is also generally along the first transverse axis 700. The third bend interruption 373 is similar to the first bend interruption 372 except for the following:

[0129] An additional abutment 470 is provided between the edge 330 of the substrate 300 and the lateral edge of the interruption 373 .

[0130] The two abutments 470 may be configured and arranged to increase or maintain resistance to bending.

[0131] Figure 4A Also depicted is a fourth bend point comprising three discontinuities 374 disposed along a fourth bending axis 774, also generally along the first transverse axis 700. The fourth bend point is similar to the third bend discontinuity 373 except that:

[0132] - comprises three curved interruptions 374 , each curved interruption having a lateral extent that is less than one third of the lateral extent of the third curved interruption 373 ,

[0133] - comprising four abutments 470 .

[0134] The two abutments 470 may be configured and arranged to increase or maintain resistance to bending.

[0135] Figure 4B A fifth example 104 of an implantable distal end of a stimulation device is depicted.

[0136] The fifth example 104 includes a fifth inflection point that includes two discontinuities 375 disposed substantially along the longitudinal axis 600. The discontinuities 375 are similar to those described above with respect to Figure 4A Described curved interruption.

[0137] In this case, the abutment 470 is disposed adjacent to and between two curved interruptions 375 disposed generally along the longitudinal axis 600 .

[0138] The abutment 470 may be configured and arranged to increase or maintain resistance to bending.

[0139] A skilled artisan will recognize that any number of interruptions and any number of abutments can 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—if made sufficiently soft, with a low degree of resistance to bending, the substrate 300 can conform by pressing against the adjacent tissue at the point of implantation. Additionally or alternatively, the flexibility can be slightly less, allowing a health professional to bend the substrate into the appropriate configuration prior to and / or during implantation.

[0140] In addition, multiple interruptions can be provided at different angles, thereby allowing for electrode portions of different shapes. For example, one or more electrode portions 200ab, 400ab separated by one or more interruptions can be provided to provide a substrate 300 that is curved in two or more directions. The shape of the electrode portion can be, for example, polygonal, rectangular, square, or trapezoidal.

[0141] Alternatively or additionally, such bend interruptions 371, 372, 373, 374, 375 may be included in the flexible stimulation electrode 200 included in the first surface 310. Alternatively or additionally, one or more bend interruptions 371, 372, 373, 374, 375 may be included in the flexible electrodes 200, 400 included in the second surface 320.

[0142] Figure 9 An example of configuring and arranging a device to conform to a predetermined curvature is depicted. A substrate 300 is depicted as a longitudinal cross-section elongated along a longitudinal axis 600. The longitudinal axis 600 is depicted as having a desired curvature. The substrate 300 has a first surface 310 and a second surface 320 disposed along substantially parallel curved transverse planes 600, 700.

[0143] As depicted, the first surface 310 lies in a plane including the longitudinal axis 600 and a first transverse axis 700, which is substantially perpendicular to the longitudinal axis 600. As depicted, the curvature of the first surface 310 and the second surface 320 is substantially perpendicular to the plane of the cross-sectional view (substantially perpendicular to the surface of the paper). The substrate 300 has a thickness or extent D along a second transverse axis 750, which is substantially perpendicular to both the longitudinal axis 600 and the first transverse axis 700, which, as depicted, lies in the plane of the drawing (along the surface of the paper).

[0144] A flexible electrode 200, 400 is provided that is divided into four portions 200ab, 400ab and is included in the curved second surface 320. This can be any of the stimulation electrodes and / or return electrodes described above. The electrode 200, 400 includes three curved interruptions 500, thereby providing three bending points / axes (not depicted) generally along the first transverse axis 700. For clarity, the adjacent portion 470 is not depicted, but the bending points 500 can be the same as those described above with respect to the first transverse axis 700. Figure 4A and Figure 4B Any configuration described.

[0145] As depicted, the nominal curvature of substrate 300 is R1, from the center point of curvature to a central plane midway between first surface 310 and second surface 320 along second transverse axis 750. The conformal curvature of substrate 300 is R2, from the center point of curvature to curved second surface 320. The thickness of the electrode (extent along second transverse axis 750) is labeled L. The thickness of substrate 300 (extent along second transverse axis 750) is labeled D. W2 is the spacing between sections. W1 is the longitudinal extent 600 of the electrode sections.

[0146] Typical values ​​are:

[0147] -R1: 100mm

[0148] -D / L: 0.150mm

[0149] -L: 0.050mm

[0150] The calculation using typical values ​​is as follows:

[0151] R2=R1–(D / 2+L)

[0152] W2 / W1=2πR2 / 2πR1=R2 / R1

[0153] R2 / R1=(R1–(D / 2+L)) / R1=1-(D / 2+L) / R1

[0154] Using these typical values, W2 / W1 = 0.998 or 99.8%.

[0155] Thus, by providing a bend interruption 500 that is 1.2% along the longitudinal axis compared to electrode portions 200ab, 400ab, and substrate 300 comprising a sufficiently flexible substrate, the device can be bent to conform to a radius of curvature of 100 mm or less. A smaller radius of curvature means a higher degree of bending.

[0156] Typically, the curvature to which the implantable distal end of the stimulation device must conform can be determined by measuring the patient.

[0157] Additionally or alternatively, a database such as the DINED database of body measurements (from 2004) can be used to determine typical values. The dimensions of these three-dimensional human models are based on anthropometric data from a survey conducted in the Netherlands in 2004. P50 refers to the percentage of people who participated in the study:

[0158] - For forehead implants, the P50 curvature for men from 2004 was 75.124mm horizontal radius and 96.615mm vertical radius;

[0159] - For forehead implants, the P50 curvature for women from 2004 was 771.089 mm horizontal radius and 93.108 mm vertical radius;

[0160] - For occipital implants, the P50 curvature for men from 2004 was 74.916 mm horizontal radius and 96.095 mm vertical radius;

[0161] - For occipital implants, the P50 curvature for women from 2004 was 70.641 mm horizontal radius and 91.42 mm vertical radius;

[0162] Thus, by appropriate configuration, a curvature radius of 90 mm to 96 mm can be provided.

[0163] The dimensions of these three-dimensional human models are based on anthropometric data from a survey conducted in the Netherlands in 2004. P50 refers to the percentage of people who participated in the study. For both the frontal and occipital regions, the radius of the most curved edge was defined with the aid of the osculating circle:

[0164] - For male P50, the radius of the forehead osculating circle is 63.019mm;

[0165] - For male P50, the radius of the occipital osculating circle is 60.458 mm;

[0166] - For female P50, the radius of the forehead osculating circle is 58.195mm;

[0167] - For female P50, the radius of the occipital osculating circle is 56.228 mm;

[0168] Thus, by appropriate configuration, a radius of curvature of 55 mm to 65 mm can be provided.

[0169] The dimensions of these 3D human models are based on anthropometric data from a survey conducted in the Netherlands in 2004. P5 and P95 refer to the percentage of people who participated in the study, where P5 represents the smallest total sample size and P95 represents the largest total sample size.

[0170] For both the frontal and occipital regions, the radius of the most curved edge is defined with the aid of the osculating circle:

[0171] - For male P95, the horizontal radius is 79.00mm, the vertical radius is 100.477mm and the radius of the forehead osculating circle is 67.361mm;

[0172] - For male P95, the horizontal radius is 79.423mm, the vertical radius is 102.003mm, and the radius of the occipital osculating circle is 66.237mm;

[0173] - For female P5, the horizontal radius is 64.68 mm, the vertical radius is 83.336 mm, and the radius of the forehead osculating circle is 49.585 mm; and

[0174] -For female P5, the horizontal radius is 65.578 mm, the vertical radius is 85.21 mm, and the radius of the occipital osculating circle is 48.035 mm.

[0175] Thus, by appropriate configuration, a curvature radius of 45 mm to 80 mm can be provided.

[0176] Figure 8 A view of a first surface 310 of a sixth example 105 of an implantable distal end of a stimulation device is depicted.

[0177] Figure 8 yes Figure 4A A modification of the flexible return electrode 400 depicted in . Figure 8 Also depicted is a flexible electrode 400 having a longitudinal extent along a longitudinal axis 600 and a lateral extent along a first lateral axis 700, which is substantially perpendicular to the longitudinal axis 600. The flexible electrode 400 generally includes one or more bend discontinuities 500.

[0178] Figure 8 and Figure 4A The difference is:

[0179] - Figure 8 The six curved interruption parts 371 (such as Figure 4A The six bend interruptions 371 are configured and arranged to provide substantially identical bending characteristics and substantially identical bending resistance between each portion 400ab, as depicted in FIG. (a) and (b) about a plurality of bend axes 771. In this case, the bend axes 771 are substantially identical to the first transverse axis 700. Since the interruptions 771 are configured and arranged substantially identically, highly uniform bending resistance is provided.

[0180] Figure 5 and Figure 6Depicted are examples of nerves that may be stimulated using an appropriately configured implantable distal end of a stimulation device 100, 101, 102, 103, 104, 105, 106, 107 to provide neural stimulation to treat, for example, headache or primary headache.

[0181] Figure 5 Depicted are left and right supraorbital nerves 910, 920, which may be electrically stimulated using an appropriately configured device. Figure 6 Depicted are left and right greater occipital nerves 930, 940, which may also be electrically stimulated using an appropriately configured device.

[0182] 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 treatment. Approximate implant locations for the distal portion of the stimulation device, including stimulation devices 100, 101, 102, 103, 104, 105, 106, 107, are depicted as areas:

[0183] - Location 810 for left supraorbital stimulation and location 820 for right supraorbital stimulation for treating chronic headaches such as migraines and cluster headaches.

[0184] - Location 830 for left occipital stimulation and location 840 for right occipital stimulation for treating chronic headaches such as migraines, cluster headaches and occipital neuralgia.

[0185] In many cases, these will be approximate locations 810 , 820 , 830 , 840 for the implantable devices 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 .

[0186] A separate stimulation system may be used for each implant location 810, 820, 830, 840. Where the implant locations 810, 820, 830, 840 are close together or even overlap, a single stimulation system may be configured to stimulate at more than one implant location 810, 820, 830, 840.

[0187] The plurality of stimulation devices 100, 101, 102, 103, 104, 105, 106, 107 may be operated individually, simultaneously, sequentially, or any combination thereof to provide the desired therapy.

[0188] Figure 7 Additional examples of nerves that can be stimulated using appropriately configured improved implantable devices 100, 101, 102, 103, 104, 105, 106, 107 to provide neural stimulation to treat other conditions are depicted. Figure 5 and Figure 6The positions (810, 820, 830, 840) depicted in Figure 7 Depicted in.

[0189] 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 treatment. Approximate implant locations for the portion of the stimulation device that includes the stimulation electrodes are depicted as areas:

[0190] - Location 810 for cortical stimulation, for treating epilepsy;

[0191] - Position 850 for deep brain stimulation for tremor control in Parkinson's disease patients; treatment of dystonia, obesity, essential tremor, depression, epilepsy, obsessive-compulsive disorder, Alzheimer's disease, anxiety, bulimia, tinnitus, traumatic brain injury, Tourette syndrome, sleep disorders, autism, bipolar disorder; and stroke recovery;

[0192] - Position 860 for vagus nerve stimulation for the treatment of epilepsy, depression, anxiety, bulimia, obesity, tinnitus, obsessive-compulsive disorder, and heart failure;

[0193] - Position 860 for carotid artery or carotid sinus stimulation for treating hypertension;

[0194] - Position 860 for hypoglossal and phrenic nerve stimulation for the treatment of sleep apnea;

[0195] - Location 865 for spinal cord stimulation of the brain for the treatment of chronic neck pain;

[0196] - Position 870 for peripheral nerve stimulation, used to treat limb pain, migraine, and pain in the limbs;

[0197] - Position 875 for spinal cord stimulation, used to treat chronic low back pain, angina, asthma, and general pain;

[0198] - Targeting gastric irritation position 880, used to treat obesity, bulimia, and interstitial cystitis;

[0199] - Location 885 for sacral and pudendal nerve stimulation for the treatment of interstitial cystitis;

[0200] - Targeting sacral nerve stimulation at position 885 for the treatment of urinary and fecal incontinence;

[0201] - Location 890 for sacral nerve modulation for bladder control therapy; and

[0202] - Position 895 for peroneal nerve stimulation for the treatment of gait or foot drop.

[0203] Other conditions that can be treated include gastroesophageal reflux disease and inflammatory diseases.

[0204] The description herein should not be understood as prescribing a fixed order in which the method steps described herein must be performed. Rather, the method steps may be performed in any feasible order. Similarly, these examples are provided to explain the algorithms and are not intended to represent the only implementation of these algorithms—those skilled in the art will be able to envision many different ways to implement the same functionality as provided by the embodiments described herein.

[0205] The implantable distal end of various types of stimulation devices is depicted. This does not preclude the remainder of the device from being implanted. This should be interpreted as meaning that at least the electrode portion of the distal end is preferably configured and arranged to be implanted.

[0206] In general, for any configuration described and depicted in this disclosure, any electrode 200, 400 can be connected as a stimulation electrode 200 or a return electrode 400. This may be advantageous if it is uncertain whether the implantable distal end is above or below the target tissue - for example, above or below a nerve.

[0207] This may be advantageous if there is uncertainty as to whether the implantable distal end is above or below the target tissue—eg, above or below a nerve.

[0208] Although the present invention has been described with reference to specific exemplary embodiments, it should be understood that various changes, substitutions and alterations apparent to those skilled in the art may be made to the disclosed embodiments without departing from the spirit and scope of the invention as set forth in the appended claims.

[0209] Reference numerals used in the drawings

[0210] 100 First implantable distal end of stimulation device

[0211] 101 Second implantable distal end of the stimulation device

[0212] 102 The third implantable distal end of the stimulation device

[0213] 103 The fourth implantable distal end of the stimulation device

[0214] 104 Fifth implantable distal end of the stimulation device

[0215] 105 Sixth implantable distal end of the stimulation device

[0216] 106 First implantable distal end of the stimulation device

[0217] 200 One or more stimulation electrodes

[0218] 200ab One or more stimulation electrode sections

[0219] 250 One or more stimulation electrical interconnects

[0220] 300 Long substrate

[0221] 310 first substantially flat lateral surface

[0222] 320 second substantially flat lateral surface

[0223] 371 First bend interruption

[0224] 372 Second bend interruption

[0225] 373 Third bend interruption

[0226] 374 Fourth bend interruption

[0227] 375 Fifth Bend Interruption

[0228] 400 One or more return electrodes

[0229] 400ab One or more return electrode sections

[0230] 450 One or more return electrical interconnects

[0231] 470 one or more adjacent parts

[0232] 500 Bend break

[0233] 600 vertical axis

[0234] 700 First Horizontal Axis

[0235] 750 Second horizontal axis

[0236] 771 First bending axis / point

[0237] 772 Second bending axis / point

[0238] 773 Third bending axis / point

[0239] 774 Fourth bending axis / point

[0240] 810 Location of stimulation for the left supraorbital nerve or cortex

[0241] 820 Position for right supraorbital stimulation

[0242] 830 Location of left occipital nerve stimulation

[0243] 840 Position for right occipital nerve stimulation

[0244] 850 Locations for Deep Brain Stimulation

[0245] 860 Targeting sites for stimulation of the vagus nerve, carotid artery, carotid sinus, phrenic nerve, or hypoglossal nerve

[0246] 865 Location of spinal cord stimulation for the brain

[0247] 870 Locations for peripheral nerve stimulation

[0248] 875 Locations for Spinal Cord Stimulation

[0249] 880 Targeting gastric irritation

[0250] 885 Locations for sacral and pudendal nerve stimulation

[0251] 890 Positions for Sacral Nerve Regulation

[0252] 895 Location of peroneal nerve stimulation

[0253] 910 Left supraorbital nerve

[0254] 920 Right supraorbital nerve

[0255] 930 Left greater occipital nerve

[0256] 940 Right greater occipital nerve

Claims

1. An implantable stimulation device (100, 101, 102, 103, 104, 105, 106, 107), comprising: - an elongated substrate (300) arranged along a longitudinal axis (600), said substrate having a first surface (310) and a second surface (320) arranged along substantially parallel transverse planes (600, 700), The substrate (300) further comprises: - a flexible electrode (200, 400) included in the first surface (310) or the second surface (320) and configured to be in contact with human or animal tissue in use; and - one or more interconnects (250, 450) physically connected to the first surface (310) and the second surface (320) and disposed between the first surface (310) and the second surface (320); The flexible electrode (200, 400) further includes: - a first portion (200ab, 400ab) disposed along a first portion plane, and - a second portion (200ab, 400ab) disposed along a second portion plane, the first portion and the second portion being directly electrically connected via the one or more interconnects (250, 450) between the first portion and the second portion, and the first portion and the second portion being separated by one or more curved interruptions (500, 371, 372, 373, 374, 375); wherein the one or more bend interruptions are configured and arranged to have a lower bending resistance than the first portion and the second portion, thereby allowing the orientation of the first portion plane to deviate from the orientation of the second portion plane at the one or more bend interruptions (500, 371, 372, 373, 374); The flexible electrode (200, 400) further includes one or more adjacent portions (470) near the one or more bending interruptions (500, 371, 372, 373, 374, 375), and the one or more adjacent portions (470) are configured and arranged to increase or maintain the bending resistance between the first part and the second part (200ab, 400ab).

2. The implantable stimulation device according to claim 1, wherein: - the compliant shape of the flexible electrode (200, 400) in cross section comprises one or more curved interruptions (500, 371) separating the first portion and the second portion, the first portion and the second portion having a higher stiffness than the curved interruptions.

3. The implantable stimulation device of claim 1 , wherein: - the flexible electrode (200, 400) has a longitudinal extent along the longitudinal axis (600); as well as - The one or more bend interruptions (500, 375) are configured and arranged to allow deviation about the longitudinal axis (600).

4. The implantable stimulation device of claim 1 , wherein: - the flexible electrode (200, 400) has a lateral extent along a first lateral axis (700), the lateral axis (700) being substantially perpendicular to the longitudinal axis (600); - the one or more bend interruptions (500, 371, 372, 373, 374, 375) are configured and arranged to allow deviation about a transverse axis (700, 771, 772, 773, 774); as well as - the one or more curved interruptions (500, 371, 372, 373, 374, 375) are provided between the first portion and the second portion and physically separate the first portion and the second portion.

5. The implantable stimulation device of claim 1 , wherein: - the tissue contacting surface of the first portion (200ab, 400ab) is arranged along the first portion plane, and - The tissue contacting surface of the second portion (200ab, 400ab) is arranged along the second portion plane.

6. The implantable stimulation device according to claim 1, wherein The one or more bend interruptions (500, 371, 372, 373, 374, 375) include one or more openings.

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

8. The implantable stimulation device of claim 1 , wherein: The flexible electrode is configured and arranged as a return electrode (400).

9. The implantable stimulation device according to claim 8, wherein The device (100, 101, 102, 103, 104) also includes one or more stimulation electrodes (200), and the return electrode (400) is configured to provide an electrical return for the one or more stimulation electrodes (200) in use.

10. The implantable stimulation device according to claim 8, wherein One or more stimulation electrodes (200) are included in the second surface (320), and the return electrode (400) is included in the second surface (320).

11. The implantable stimulation device according to claim 8, wherein One or more stimulation electrodes (200) and the return electrode (400) are included in the first surface (310) or the second surface (320).

12. The implantable stimulation device according to any one of claims 1 to 11, 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) are configured and arranged to provide stimulation energy to one or more flexible electrodes (200, 400); the one or more additional interconnects (250) are physically connected to the first portion and the second portion; and the first portion and the second portion cover at least a portion of the one or more additional interconnects (250).

13. The implantable stimulation device according to claim 1, wherein The substrate (300) comprises: - Biocompatible polymers.

14. The implantable stimulation device according to claim 1, wherein The substrate (300) comprises: - Biocompatible elastomer.

15. The implantable stimulation device according to claim 1, wherein The substrate (300) comprises: liquid crystal polymer (LCP), polyimide, polyparaxylene or any combination thereof.

16. A stimulation system comprising: - an implantable stimulation device (100) according to any one of claims 1 to 15; and - a source of electrical energy configured and arranged to provide energy to the flexible electrode (200, 400) in use.

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