Patent Publication Number: US-2021170176-A1

Title: Implantable stimulator with an electrode array and conformable substrate

Description:
This application is a continuation-in-part of U.S. patent application Ser. No. 17/063,568, filed on Oct. 4, 2020 with the USPTO, which is a continuation-in-part of U.S. patent application Ser. No. 16/703,706, filed on Dec. 4, 2019 with the USPTO. 
     This application also claims the benefit of Dutch Patent Application N2025268, filed Apr. 3, 2020 with the Netherlands Patent Office. 
     This application is also a continuation-in-part of PCT application PCT/IB2020/061474, filed with WIPO Dec. 4, 2020, which claims priority to U.S. patent application Ser. No. 16/703,706, filed on Dec. 4, 2019 with the USPTO, and Dutch Patent Application N2025268, filed Apr. 3, 2020 with the Netherlands Patent Office. All of the aforementioned applications are hereby incorporated by reference in their entireties. 
    
    
     COPYRIGHT NOTICE 
     A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. 
     TECHNICAL FIELD 
     The present disclosure relates to an implantable stimulator, for providing electrical stimulation to human or animal tissue, having an electrode array located along a conformable portion of a substrate, In particular, it relates to an implantable stimulator having an encapsulation layer at least partially covering a portion of the substrate. It also relates to a method of manufacturing an implantable stimulator. 
     BACKGROUND 
     Implantable electrical stimulation systems may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as headaches, lower back pain and incontinence. 
     In many electrical stimulation applications, it is desirable for a stimulator, typically comprising a therapeutic lead (a lead comprises electrodes and electrical connections), to provide electrical stimulation to one or more precise locations within a body—in many cases, precisely aligning the stimulation electrodes during implantation may be difficult due to the curvature of tissues and anatomical structures. A mismatch in curvature of the electrode section of a lead may create unexpected and/or unpredictable electrical resistance between one or more electrodes and the underlying tissue. In addition, repeated movement of the relevant areas of the body may even worsen the mismatch. A particular problem with subcutaneous implants is that even small differences in flexibility between the implant and surrounding tissue may affect patient comfort, and can cause irritation of the overlying skin. This is a particular problem with sub-cutaneous implants. 
     In particular, the use of neurostimulation leads in the craniofacial region is associated with skin erosion and lead migration. The cylindrical shape and associated thickness of state-of-the-art leads results in the lead eroding through the skin or results in the lead being displaced so that the electrodes no longer cover the targeted nerves. 
     More recently, use has been made of plastics and polymers, which have an inherent flexibility or may be made in a curved shape—for example, as described in US application US 2016/0166828. Although such leads may be manufactured in a curved-shape or deformed by human manual manipulation during implantation, this is inconvenient. The high degree of anatomic variability found in humans and animals means that a manufacturer must provide either a large range or pre-curved leads or allow the leads to be made to measure. In the case that they are deformable during implantation, this further complicates the implantation process. 
     Implantable active devices require a protection method to protect the implant electronics from bodily fluids present in human or animal bodies. Bodily fluids typically contain ions that may cause electrochemical reactions, like corrosion, in the presence of an electric current. Encapsulation is thus a critical component for the design of a medical device—it acts as a barrier between these ionic fluids and critical electronic/electric interfaces to reduce and/or prevent degradation of the implant electronics. 
     Polyimides are popular for use as a substrate material for the microfabrication of electronics, and attempts have been made to encapsulate polyimides with silicone rubber encapsulants, such as polydimethylsiloxane rubber (PDMS). As described in “Irreversible bonding of polyimide and polydimethylsiloxane (PDMS) based on a thiol-epoxy click reaction”, Hoang, Chung and Elias, Journal of Micromechanics and Microengineering, 10.1088/0960-1317/26/10/105019, bonding these two flexible materials remains a crucial challenge—the resistance to fluid ingress may be reduced by the encapsulant delaminating to some degree from the substrate. The degree of bonding was increased by functionalizing the surfaces of the PDMS and polyimide substrates with mercaptosilanes and epoxysilanes, respectively, for the formation of a thiolepoxy bond in the click reaction. It was also increased by functionalizing one or both surfaces with mercaptosilane and introducing an epoxy adhesive layer between the two surfaces. 
     Although PDMS can be substantially biocompatible, causing minimal tissue reaction while having a relative long period of biostability, it still has a relatively high permeability to moisture which can lead to degradation of the implant electronics. Many other encapsulants with a lower degree of moisture permeability may have a lower degree of biocompatibility. Recently, LCP&#39;s (Liquid Crystal Polymers) have been considered for use as a substrate for electronics, and there is also a need for improved bonding techniques between LCP and encapsulants. 
     SUMMARY 
     It is to be understood that both the following summary and the detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed. Neither the summary nor the description that follows is intended to define or limit the scope of the invention to the particular features mentioned in the summary or in the description. Rather, the scope of the invention is defined by the appended claims. 
     In certain embodiments, the disclosed embodiments may include one or more of the features described herein. 
     An implantable stimulator is provided, comprising: a substrate, the substrate comprising a first and second surface, wherein a thickness of the substrate is defined by the first and second surfaces; a pulse generator configured to generate at least one stimulation pulse; and an electrode array comprising at least two electrodes located along a conformable portion of the substrate; the implantable stimulator further comprising: a plurality of electrical interconnections electrically coupling the pulse generator to the at least two electrodes of the electrode array; wherein the plurality of electrical interconnections are positioned between the first and second surfaces of the substrate; wherein the thickness of the substrate along the conformable portion is equal to or less than 0.5 millimeters. 
     The products and methods described herein provide a high degree of conformability as well as high degree of configurability. A higher degree of conformability may increase the comfort for the user. Optionally, the thickness of the conformable portion is equal to or less than 0.3 millimeters, or equal to or less than 0.2 millimeters, or equal to or less than 0.1 millimeters. 
     Optionally, wherein the substrate comprises a further portion along which the pulse generator s located, the implantable stimulator further comprising an encapsulation layer at least partially covering the further portion of the substrate. Additionally or alternatively, the further portion of the substrate and pulse generator are at least partially embedded in one or more flexible bio-compatible encapsulation layers. 
     Encapsulation may improve the reliability and/or lifetime of the implantable substrate. 
     Additionally or alternatively, the implantable stimulator further comprises an adhesion layer adjacent to at least part of the substrate. Optionally, the substrate comprises more than one adjacent substrate layer and the adhesion layer is between substrate layers. 
     One or more adhesion layers may improve the performance of the encapsulation. This may also improve the reliability and/or lifetime of the implantable substrate. By providing a multilayer, thinner leads may be used, adding to the flexibility and therefore improving conformability. 
     Optionally, the adhesion layer comprises a ceramic material. A ceramic material may be advantageous comprised in an adhesion layer between a substrate material and encapsulant material. 
     Optionally, the ceramic material is selected from the group consisting of: HfO2, Al2O3, Ta2O3, SiC, Si3N4, TiO2, and any combination thereof. 
     Additionally or alternatively, the adhesion layer comprises at least one first layer comprising HfO2 and at least one second layer adjacent to the at least one first layer and comprising Al2O3. Additionally or alternatively, the adhesion layer comprises at least one first layer comprising Ta2O3 and at least one second layer adjacent to the at least one first layer and comprising Al2O3. Additionally or alternatively, the adhesion layer comprises at least one first layer comprising TiO2 and at least one second layer adjacent to the at least one first layer and comprising Al2O3. 
     Optionally, a ceramic portion of the adhesion layer has an average thickness in the range of 25 nm to 200 nm. Optionally, the adhesion layer comprises a ceramic portion that is applied using atomic layer deposition (ALD). 
     Additionally or alternatively, the thickness of the stimulator along the further portion is equal to or less than 5 millimeters, or equal to or less than 4 millimeters, or equal to or less than 3 millimeters. 
     This may further improve conformability of the further portion of the substrate. 
     Additionally or alternatively, the plurality of electrical interconnections are positioned between the first and second surfaces of the substrate using metallization. Additionally or alternatively, the plurality of electrical interconnections are comprised in one or more conductive interconnection layers, the one or more conductive interconnection layers being comprised between two adjacent polymeric substrate layers. 
     By providing a more easily patternable substrate, more complicated electrode array configurations may be supported, allowing a higher degree of flexibility to address transverse and/or longitudinal misalignment. 
     A method of manufacturing an implantable stimulator is provided, comprising: providing a substrate, the substrate comprising a first surface and a second surface, wherein a thickness of the substrate is defined by the first and second surfaces; providing a pulse generator, the pulse generator being configured to generate at least one stimulation pulse; locating an electrode array comprising at least two electrodes along a conformable portion of the substrate; and depositing or electro-plating onto the substrate a plurality of electrical interconnections; electrically coupling the pulse generator to the at least two electrodes of the electrode array; wherein the thickness of the substrate along the conformable portion is equal to or less than 0.5 millimeters. 
     Optionally, the pulse generator is provided along a further portion of the substrate, the method further comprising at least partially covering the further portion of the substrate with an encapsulation layer. 
     Additionally or alternatively, the stimulator further comprises: an encapsulation layer at least partially covering the substrate; and an adhesion layer between the encapsulation layer and the substrate in at least one location. 
     Additionally or alternatively, the encapsulation layer covers at least part of the conformable portion of the substrate, and the adhesion layer is between the encapsulation layer and the at least part of the conformable portion of the substrate. 
     Such products and associated methods described herein provide improved bonding to improve resistance to fluid ingress in implantable devices comprising flexible substrates. The encapsulant/adhesion layer may be optimized to protect a surface of many types of substrates. If the substrate is configured and arranged to be substantially flexible, the substrate may have a high degree of conformability. The high degree of adhesion of the encapsulant/adhesion layer allows the flexible encapsulant layer to provide a high degree of ingress protection for one or more surfaces of a flexible substrate. 
     One or more regions of a substrate surface may be protected by an encapsulant/adhesion layer. Each encapsulant/adhesion layer may be optimized separately or together to a predetermined degree. 
     Optionally, the conformable portion of the substrate comprises a liquid crystal polymer (LCP). 
     Additionally or alternatively, wherein the substrate comprises a further portion along which the pulse generator is located, the encapsulation layer at least partially covering the further portion of the substrate. 
     Optionally, the encapsulation layer comprises a polymer and/or Polydimethylsiloxane (PDMS). 
     By providing a bilayer having an encapsulant comprising a PDMS and a conformal adhesion layer comprising ceramic materials, the adhesion layer appears to show significantly higher stability in ionic media, thereby providing relatively longer protection in case of any delamination or water permeation through the encapsulant. A PDMS may further contribute to longer-lasting adhesion and defect reduction due to flowing in-between any defects and crevices in the adhesion layer—in particular, a PDMS with a relatively low viscosity may provide an even higher degree of defect reduction. 
     The ceramic materials HfO2, Al2O3, Ta2O3, SiC, Si3N4, TiO2, and any combination thereof, may be advantageously used as in an adhesion layer for a PDMS encapsulant layer. 
     A method of manufacturing an implantable stimulator is provided, comprising: providing a substrate, the substrate comprising a first surface and a second surface, wherein a thickness of the substrate is defined by the first and second surfaces;—providing a pulse generator, the pulse generator being configured to generate at least one stimulation pulse; locating at least two electrodes along a conformable portion of the substrate; depositing or electro-plating onto the substrate a plurality of electrical interconnections electrically coupling the pulse generator to the at least two electrodes; applying an adhesion layer at least partially covering the substrate; and applying an encapsulation layer over the adhesion layer; wherein the thickness of the substrate along the conformable portion is equal to or less than 0.5 millimeters. 
     Optionally, the adhesion layer is applied using atomic layer deposition (ALD). Additionally or alternatively, the pulse generator is provided along a further portion of the substrate, wherein the adhesion layer and encapsulation layer are applied to at least partially cover the further portion of the substrate. 
     In further embodiments of the disclosure, an implantable stimulator is presented, which comprises: a substrate, the substrate comprising a first surface and a second surface, wherein a thickness of the substrate is defined by the first and second surfaces; a pulse generator located along a first portion of the substrate, the pulse generator being configured to generate at least one stimulation pulse; an electrode array comprising at least two electrodes located along a second, conformable Liquid Crystal Polymer (LCP) portion of the substrate; a plurality of electrical interconnections electrically coupling the pulse generator to the at least two electrodes of the electrode array; wherein the plurality of electrical interconnections are positioned on a first conformable LCP layer of the substrate using electro-plating and/or a semiconductor deposition technique and an at least one second conformable LCP layer of the substrate is secured to the first layer so as to cover the plurality of electrical interconnections; a biocompatible encapsulation layer covering the first portion and at least part of the second portion of the substrate, the encapsulation layer comprising Polydimethylsiloxane (PDMS) and having a tensile strength in the range 6 to 8 MPa; and one or more biocompatible adhesion layers conforming to the substrate and positioned between the encapsulation layer and the substrate; wherein the adhesion layer comprises a ceramic portion having an average thickness in the range of 25 nm to 200 nm that is applied using atomic layer deposition (ALD), and comprises at least one first layer comprising TiO 2  and at least one second layer adjacent to the at least one first layer and comprising Al 2 O 3 ; wherein the second portion of the substrate has a Young&#39;s modulus in the range 2500 to 3600 MPa; wherein the adhesion layer and the encapsulation layer are configured to resist ingress of fluids onto the substrate; wherein the thickness of the substrate along the second portion is equal to or less than 0.2 millimeters; wherein a thickness of the stimulator along the first portion is equal to or less than 4 millimeters; and wherein the pulse generator comprises an energy receiver configured to wirelessly receive energy from an energy transmitter which comprises further comprise an implantable stimulator. 
     In additional embodiments, an implantable stimulator comprises: a substrate comprising a first surface and a second surface, wherein a thickness of the substrate is defined by the first and second surfaces; a pulse generator being configured to generate at least one stimulation pulse; at least two electrodes located along a conformable portion of the substrate; a plurality of electrical interconnections electrically coupling the pulse generator to the at least two electrodes; an encapsulation layer at least partially covering the substrate; and an adhesion layer between the encapsulation layer and the substrate in at least one location; wherein the thickness of the substrate along the conformable portion is equal to or less than 0.5 millimeters. In some embodiments, the thickness of the substrate along the conformable portion may be equal to or less than 0.3 millimeters. 
     In any of the implantable stimulators described above herein, the encapsulation layer may cover at least part of the conformable portion of the substrate, and the adhesion layer may be between the encapsulation layer and the at least part of the conformable portion of the substrate. The conformable portion of the substrate may also comprise one or more layers of the LCP. The substrate may additionally comprise a further portion along which the pulse generator is located, the encapsulation layer at least partially covering the further portion of the substrate. In some embodiments, the further portion of the substrate is also conformable, and the further portion may be LCP. Additionally, the thickness of the stimulator along the further portion may be equal to or less than 5 millimeters. The thickness of the stimulator along the further portion may also be equal to or less than 4 millimeters. 
     The adhesion layer may additionally comprise a ceramic material, which may be selected from the group consisting of: HfO 2 , Al 2 O 3 , Ta 2 O 3 , SiC, Si 3 N 4 , TiO 2 , and any combination thereof. In at least one embodiment, the adhesion layer comprises at least one first layer comprising HfO 2  and at least one second layer adjacent to the at least one first layer and comprising Al 2 O 3 . In a further embodiment, the adhesion layer comprises at least one first layer comprising Ta 2 O 3  and at least one second layer adjacent to the at least one first layer and comprising Al 2 O 3 . The adhesion layer may also comprise at least one first layer comprising TiO 2  and at least one second layer adjacent to the at least one first layer and comprising Al 2 O 3 . 
     In at least one embodiment of the implantable stimulator, the conformable part of the substrate has a Young&#39;s modulus in the range 2500 to 3600 MPa. Additionally, the encapsulation layer may have a tensile strength in the range 6 to 8 MPa. 
     Any of the implantable stimulators described above herein may further comprise other adhesion layers, wherein the substrate comprises more than one substrate layer and the other adhesion layers are between substrate layers. 
     In at least one embodiment, the encapsulation layer covers the first surface of the substrate and not the second surface, further comprising a second encapsulation layer covering the second surface of the substrate. 
     In a further embodiment, the adhesion layer is biocompatible. The adhesion layer may also conform to the first surface and/or the second surface of the substrate. Both the adhesion layer and the encapsulation layer may also be configured to resist ingress of fluids onto the substrate. The encapsulation layer may comprise Polydimethylsiloxane (PDMS). 
     In additional embodiments, a ceramic portion of the adhesion layer has an average thickness in the range of 25 nm to 200 nm. The conformable portion of the substrate may comprise a substance selected from the group consisting of: a Liquid-Crystal Polymer (LCP), a polyimide, Parylene-C, SU-8, a polyurethane, or any combination thereof. 
     The implantable stimulator in at least one embodiment has a substrate that comprises a first conformable layer and at least one second conformable layer, wherein the plurality of electrical interconnections are positioned along the first layer using a deposition technique, and wherein the at least one second layer is secured to the first layer so as to cover the plurality of electrical interconnections. 
     In at least a further embodiment, an implantable stimulator comprises: a substrate, the substrate comprising a top surface and a bottom surface; a pulse generator located along a first portion of the substrate, the pulse generator being configured to generate at least one stimulation pulse; at least two electrodes located along a second, conformable portion of the substrate; a plurality of electrical interconnections electrically coupling the pulse generator to the at least two electrodes; wherein the plurality of electrical interconnections are positioned between the top and bottom surfaces of the substrate; an encapsulation layer covering at least part of the first portion of the substrate; and an adhesion layer between the encapsulation layer and the substrate in at least one location; wherein a maximum thickness of the substrate in the second portion is equal to or less than 0.5 millimeters. 
     Additionally disclosed herein is a method of manufacturing an implantable stimulator, the method comprising: providing a substrate, the substrate comprising a first surface and a second surface, wherein a thickness of the substrate is defined by the first and second surfaces; providing a pulse generator, the pulse generator being configured to generate at least one stimulation pulse; locating at least two electrodes along a conformable portion of the substrate; depositing or electro-plating onto the substrate a plurality of electrical interconnections electrically coupling the pulse generator to the at least two electrodes; applying an adhesion layer at least partially covering the substrate; and applying an encapsulation layer over the adhesion layer; wherein the thickness of the substrate along the conformable portion is equal to or less than 0.5 millimeters. 
     In some embodiments of the method, the adhesion layer is applied using atomic layer deposition (ALD). In further embodiments, the pulse generator is provided along a further portion of the substrate, wherein the adhesion layer and encapsulation layer are applied to at least partially cover the further portion of the substrate. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Certain illustrative embodiments illustrating organization and method of operation, together with objects and advantages may be best understood by reference to the detailed description that follows, taken in conjunction with the accompanying drawings, which are not necessarily drawn to scale. 
       The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate exemplary embodiments and, together with the description, further serve to enable a person skilled in the pertinent art to make and use these embodiments and others that will be apparent to those skilled in the art: 
         FIG. 1A  is a transverse view of a first implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 1B  is a top view of a first implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 1C  is a bottom view of a first implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 2A  is a transverse view of a second implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 2B  is a top view of a second implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 2C  is a bottom view of a second implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 3A  is a transverse view of a third implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 3B  is a top view of a third implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 3C  is a bottom view of a third implementation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 4A  is a first view of alternative electrode configurations of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 4B  is a second view of alternative electrode configurations of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 4C  is a third view of alternative electrode configurations of an implantable 30 stimulator consistent with certain embodiments of the present invention. 
         FIG. 5  presents locations of nerves in the anterior portion of a human head that may be treated through operation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 6  presents locations of nerves in the posterior portion of a human body that may be treated through operation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIG. 7  presents locations of nerves in a human body that may be treated through operation of an implantable stimulator consistent with certain embodiments of the present invention. 
         FIGS. 8A and 8B  depict Electrochemical Impedance Spectroscopy (EIS) as Bode plot results of  FIG. 8A : impedance magnitude and  FIG. 8B : phase angle for three samples. 
         FIGS. 8C and 8D  depict EIS results at 10 −2  Hz over four hundred and fifty days of soaking as  FIG. 8C : impedance magnitude and  FIG. 8D : phase angle for four samples. 
         FIG. 9  presents measurement results comparing the average pull force, dry and after soaking, of LCP coated with PDMS using different processes. 
         FIG. 10  depicts a cross-section through a test sample. 
         FIG. 11A ,  FIG. 11B  and  FIG. 11C  depict cross-sections through improved implantable electrical devices. 
         FIG. 12A  and  FIG. 12B  depict cross-sections through improved implantable medical devices comprising an improved implantable electrical device, and one or more electrodes. 
     
    
    
     DETAILED DESCRIPTION 
     While this invention is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail specific embodiments, with the understanding that the present disclosure of such embodiments is to be considered as an example of the principles and not intended to limit the invention to the specific embodiments shown and described. The embodiments described, and their detailed construction and elements, are merely provided to assist in a comprehensive understanding of the invention. The scope of the invention is best defined by the appended claims. In the description below, like reference numerals are used to describe the same, similar or corresponding parts in the several views of the drawings or even in different drawings. 
     Thus, it is apparent that the present invention can be carried out in a variety of ways, and does not require any of the specific features described herein. Also, well-known functions or constructions are not described in detail since they would obscure the invention with unnecessary detail. Any signal arrows in the drawings/figures should be considered only as exemplary, and not limiting, unless otherwise specifically noted, 
     It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of example embodiments. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. As used herein, “at least one of A, B, and C” indicates A or B or C or any combination thereof. As used herein, the singular form of a word includes the plural, and vice versa, unless the context clearly dictates otherwise. 
     The terms “a” or “an”, as used herein, are defined as one or more than one. The term “plurality”, as used herein, is defined as two or more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language). The term “coupled”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. 
     It should also be noted that in some alternative implementations, the functions/acts noted may occur out of the order noted in the figures. For example, two figures shown in succession may in fact be executed substantially concurrently or may sometimes be executed in the reverse order, depending upon the functionality/acts involved. 
     As used herein, ranges are used herein in shorthand, so as to avoid having to list and describe each and every value within the range. Any appropriate value within the range can be selected, where appropriate, as the upper value, lower value, or the terminus of the range. 
     The words “comprise”, “comprises”, and “comprising” are to be interpreted inclusively rather than exclusively. Likewise the terms “include”, “including” and “or” should all be construed to be inclusive, unless such a construction is clearly prohibited from the context. The terms “comprising” or “including” are intended to include embodiments encompassed by the terms “consisting essentially of” and “consisting of”. Similarly, the term “consisting essentially of” is intended to include embodiments encompassed by the term “consisting of”. Although having distinct meanings, the terms “comprising”, “having”, “containing” and “consisting of” may be replaced with one another throughout the description of the invention. 
     “About” means a referenced numeric indication plus or minus 10% of that referenced numeric indication. For example, the term “about 4” would include a range of 3.6 to 4.4. All numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth herein are approximations that can vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of any claims, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches. 
     Wherever the phrase “for example,” “such as,” “including” and the like are used herein, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise. 
     “Typically” or “optionally” means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. 
     Reference throughout this document to “one embodiment”, “certain embodiments”, “an embodiment” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined by a person skilled in the art in any suitable manner in one or more embodiments without limitation. 
     In the following detailed description, numerous non-limiting specific details are given to assist in understanding this disclosure. 
       FIGS. 1A, 1B &amp; 1C  depict longitudinal cross-sections through a first embodiment  100  of an implantable stimulator comprising:
         a pulse generator  500  (only depicted in  FIGS. 1B and 1C ) for generating at least one electrical treatment stimulation pulse; and   a conformable portion of a foil-like substrate  300  having a longitudinal axis  600  extending from the pulse generator  500  to a distal end of the substrate  300 . The substrate  300  comprises one or more adjacent polymeric substrate layers and has a first  310  and a second  320  planar (outer) surface.       

     The implantable stimulator  100  also comprises:
         an electrode array  200 ,  400 , proximate the distal end, having at least one electrode of a first  200   a ,  200   b  type and at least one electrode of a second type  400   a ,  400   b . The electrodes  200 ,  400  are comprised in the first  310  or second  320  surface, and each is configurable for transferring treatment energy, in use, to (as a stimulation electrode) and/or from (as a return electrode) human or animal tissue. In this context, an array may be considered a systematic arrangement of two or more electrodes  200   a ,  200   b ,  400   a ,  400   b.  1D, 2D or 3D arrays may be provided. Optionally, they may be arranged in rows and/or columns.       

     The implantable stimulator  100  further comprises:
         one or more electrical interconnections  250 , between the pulse generator  500  and the first  200   a ,  200   b  and the second  400   a ,  400   b  electrodes, for transferring electrical energy as one or more electrical treatment stimulation pulses to the coupled first electrodes  200   a ,  200   b  and/or the second electrodes  400   a ,  400   b . The one or more electrical interconnections  250  are comprised (or positioned) between the first surface  310  and the second  320  surfaces. A plurality of electrical interconnections  250  is considered to be two, or more than two, electrical interconnections  250 .       

     In this disclosure, the conformability of the electrode array  200 ,  400  is determined to a high degree by the one or more of the following:
         the conformability of a portion of the substrate  300  proximate the electrodes  200 ,  300 ;   the arrangement and positions of the electrodes  200 ,  400 ;   the materials and dimensions (or extent) of the materials comprised in the electrodes  200 ,  400 ;   the arrangement and positions of the one or more interconnections  250  proximate the electrodes  200 ,  400 ; and   the materials and dimensions (or extent) of the materials comprised in the interconnections  200 ,  400 .       

     By suitable configuration, arrangement and optimization, an implantable electrode array  200 ,  400  may be provided which is foil-like (or film-like) and highly conformable. 
     As depicted, the conformable portion of the foil-like substrate  300  is preferably elongated along the longitudinal axis  600 , having a tape-like shape, allowing the pulse generator  500  to be disposed (or located) further away from the position of the electrodes  200 ,  400 . 
     If the substrate  300  is substantially planar (in a non-limiting example, by allowing the substrate  300  to conform to a planar surface), the first  310  and second  320  surfaces are disposed along substantially parallel transverse planes  600 ,  700 . As depicted in  FIG. 1A , the first surface  310  lies in a plane comprising the longitudinal axis  600  and a first transverse axis  700 —the first transverse axis  700  is substantially perpendicular to the longitudinal axis  600 . As depicted in  FIG. 1A , the plane of the first surface  310  is substantially perpendicular to the plane of the cross-section drawing (substantially perpendicular to the surface of the paper). 
     The conformable portion of the foil-like substrate  300  has a maximum thickness of 0.5 millimeter or less, proximate the first  200   a ,  200   b  and second  400   a ,  400   b  electrodes, the thickness being defined by the first  310  and second surfaces  320 —it may be determined by a perpendicular distance between corresponding points on the first  310  and second planar surfaces  320 . This is preferably determined when the substrate  300  conforms to a planar surface. 
     The foil-like substrate  300  has a thickness or extent along a second transverse axis  750 —this second transverse axis  750  is substantially perpendicular to both the longitudinal axis  600  and the first transverse axis  700 —it lies in the plane of the drawing (along the surface of the paper) as depicted. The first surface  310  is depicted as an upper surface and the second surface  320  is depicted as a lower surface. 
     The thickness may therefore be determined by a perpendicular distance along the second transverse axis  750  between corresponding points on the first  310  and second planar surfaces  320 . The maximum thickness of the conformable portion of the foil-like substrate  300  proximate the first  200   a ,  200   b  and second  400   a ,  400   b  electrodes is 0.5 mm or less, preferably 0.3 millimeters or less, even more preferably 0.2 millimeters or less, yet more preferably 0.1 millimeters or less. 
     In general, the lower the maximum thickness (in other words, the thinner the substrate), the higher the degree of conformance. However, a higher maximum thickness may be preferred to improve mechanical strength. 
     To clarify the differences between the different views depicted, the axes are given nominal directions:
         the longitudinal axis  600  extends from the proximal end (not depicted in  FIG. 1A , but depicted in  FIGS. 1B and 1C ) on the left, to the distal end, depicted on the right of the page;   the first transverse axis  700  extends into the page as depicted; and   the second transverse axis  750  extends from bottom to top as depicted.       

     The conformable portion of the foil-like substrate  300  may be configured and arranged as a multilayer—it comprises two or more adjacent polymeric substrate layers secured to each other, and having the first  310  and second  320  planar surface. The one or more electrical interconnections  250  are also comprised (or positioned) between the first  310  and second  320  planar surfaces. However, it is not necessary that the two or more polymeric layers and/or interconnections have similar extents along the first transverse axis  700 . In other words, within the context of this disclosure, there may be regions where an interconnection  250  is sandwiched between regions of polymeric substrate (appears as a multilayer in a longitudinal cross-section), adjacent to regions where the polymeric substrate is substantially contiguous. Similarly, there may be regions where an interconnection  250  is sandwiched between two polymeric substrate layers (appears as a multilayer in a longitudinal cross-section), adjacent to regions where the substrate comprises two adjacent substrate layers. Similarly, a substrate comprising two or more polymeric substrate layer may be modified (physically and/or chemically), such that it appears to be one layer of polymeric substrate. 
     These polymeric substrate layers are selected for suitability to be conformable, and to comprise the one or more electrical interconnections  250 . Preferably, the polymeric substrate materials are also biocompatible and durable, such as a material selected from the group comprising silicone rubber, siloxane polymers, polydimethylsiloxanes, polyurethane, polyether urethane, polyetherurethane urea, polyesterurethane, polyamide, polycarbonate, polyester, polypropylene, polyethylene, polystyrene, polyvinyl chloride, polytetrafluoroethylene, polysulfone, cellulose acetate, polymethylmethacrylate, polyethylene, and polyvinylacetate. Suitable polymer materials, including LCP (Liquid Crystal Polymer) films, 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 here as reference, depicting the properties of Polyimide (UBE U-Varnish-S), Parylene C (PCS Parylene C), PDMS (NuSil MED-1000), SU-8 (MicroChem SU-8 2000 &amp; 3000 Series), and LCP (Vectra MT1300). 
     Conformable foil-like substrates  300  are configured to follow the contours of the underlying anatomical features very closely by being flexible. Very thin foil-like substrates  300  have the additional advantage that they have increased flexibility. 
     Most preferably, the polymeric substrate layers comprise an LCP, Parylene and/or a Polyimide. LCP&#39;s are chemically and biologically stable thermoplastic polymers which allow for hermetic sensor modules having a small size and low moisture penetration. 
     Advantageously, an LCP may be thermoformed allowing complex shapes to be provided. Very thin (and subsequently very conformable) and very flat (highly planar) layers of an LCP may be provided. For fine tuning of shapes, a suitable laser may also be used for cutting. 
     In a non-limiting example, a conformable foil-like substrate  300  of LCP may have a thickness (extent along the second transverse axis  750 ) in the range 50 microns (um) to 720 microns (um), preferably 100 microns (um) to 300 microns (um). In an exemplary embodiment, values of 150 um (micron), 100 um, 50 um, or 25 um may be provided. 
     When conforming to a substantially planar surface, the foil-like surface  300  is substantially comprised in a plane with a transverse extent substantially perpendicular to the longitudinal axis  600 , wherein the planar width may be determined by a perpendicular distance between corresponding points on outer surfaces edges of the planar foil-like substrate  300  along the transverse extent. As depicted, this is along the first transverse axis  700 . In an embodiment, electrode  200 ,  400  widths of 2 mm to 20 mm may be provided using LCP. 
     At room temperature, thin LCP films have mechanical properties similar to steel. This is important as implantable substrates  300  should be strong enough to be implanted, strong enough to be removed (explanted) and strong enough to follow any movement of the neighboring anatomical features and/or structures without deteriorating. 
     LCP belongs to the polymer materials with the lowest permeability for gases and water. LCP&#39;s can be bonded to themselves, allowing multilayer constructions with a homogenous structure. 
     In contrast to LCP&#39;s, polyimides are thermoset polymers, which require adhesives for the construction of multilayer portions with electrode arrays. Polyimides are thermoset polymer material with high temperature and flexural endurance. 
     In an embodiment, an LCP may be used to provide a conformable substrate  300  as a multilayer—in other words, two or more adjacent polymeric substrate layers. In a non-limiting example, these may be layers of 25 um (micron) thickness. 
     In an embodiment, one or more electrical interconnections  250  may be provided (or positioned) between the first  310  and second  320  surfaces by metallization. These may be conductors embedded in the substrate  300  such as by having a single polymer layer and applying conductive material using suitable deposition techniques known from the semiconductor industry. 
     In an embodiment, if two or more adjacent polymeric substrate layers are provided, an interconnection layer may be provided using suitable techniques such as those from the semiconductor industry. The polymeric substrate layers may also be considered adjacent when one of more adhesion layers are used between them. Examples of suitable adhesion materials and adhesion layers are described below in relation to  FIG. 8  to  FIG. 12 . 
     In an embodiment, lamination may also be used to provide a substrate  300  with the desired physical and chemical properties, and/or to provide a convenient method of manufacture. In a non-limiting example, a substrate  300  may comprise three laminated polymer layers: two high temperature thermoplastic layers with a low-temperature layer (bond-ply) in between, and high-temperature layers towards the first surface  310  and second surface  320 . 
     In an alternative embodiment, two layers of silicone may be provided as polymeric substrate layers: one layer of silicone is provided, metal is patterned on one of its outer surfaces, and a second layer of silicone is added over the metal patterning by jetting, over-molding, or spin-coating. 
     In an embodiment, the electrical interconnections  250  may comprise one or more conductive materials, such as a metal, formed as required in one or more conductive elements: wire, strand, foil, lamina, plate, and/or sheet. They may be a substantially contiguous (one conductor). They may also comprise more than one conductor, configured and arranged to be, in use, electrically connected with each other—in other words, the one or more conductors are configured and arranged to be substantially electrically contiguous in use. 
     Alternatively, the one or more electrical interconnections  250  may be comprised in one or more conductive interconnection layers  250 , the one or more conductive interconnection layers being comprised (or positioned) between two adjacent polymeric substrate layers. As depicted in  FIG. 1A , a plurality of interconnections may be provided at different dispositions (or depths or positions) between the first surface  310  and the second surface  320 . 
     In an embodiment, an interconnection  250  in the context of this disclosure is not configured or arranged to be, in use, in contact with human or animal tissue. The one or more interconnections  250  are embedded (or covered) in one or more layers of a low conductance or insulating polymer, such as LCP. Additionally or alternatively, one or more encapsulation layers may be used. 
     One or more interconnection layers  250  may also be provided by metallization using techniques from the PCB (Printed Circuit Board) industry, such as metallization with a bio-compatible metal such as gold or platinum. Electro-plating may be used. Layers comprising LCP films are particularly suitable for metallization. These electrical interconnections  250  and/or interconnect layers  250  are configured to transfer electrical energy as one or more electrical treatment stimulation pulses from the pulse generator  500  to the coupled first electrodes  200   a ,  200   b  and/or the second electrodes  400   a ,  400   b.    
     Using suitable polymeric substrate materials, such as an LCP film, allows the conformable portions of the foil-like (or film-like) substrate  300  and electrode array  200 ,  300  to have a high width-to-height ratio, providing a bio-compatible electronic foil (or film), or bio-electronic foil (or film). 
     In an embodiment, when the substrate  300  conforms to a substantially planar surface, the ratio of maximum planar width to maximum thickness proximate the first  200   a ,  200   b  and second  400   a ,  400   b  electrodes may be 7:1 or higher, preferably 10:1 or higher, more preferably 15:1 or higher, yet more preferably 30:1 or higher, even more preferably 50:1 or higher. 
     Ratios of 100:1 or higher may also be advantageous, and may be provided using one or more mechanically strong substrate layers of an LCP film, with a width of approximately 20 mm and a thickness of approximately 0.2 mm. This provides a high degree of flexibility, and therefore also a high degree of conformability. Additional measures may also be taken to increase the degree of conformability in the first transverse direction  700 , such as varying the width of the substrate, adding one or more undulations and/or providing bending points. 
     In a non-limiting example, when using a single row of electrodes  200 ,  400  and/or electrodes  200 ,  400  with a smaller width, the width may be four mm with a thickness of approximately 0.2 mm—this is a ratio of approximately 20:1. 
     In a non-limiting example, in a portion of the substrate proximate the pulse generator  500 , greater extents may be required which further depend, to a high degree, on the dimensions of the electronic components used a width of twenty mm and a thickness of three mm. This is a ratio of approximately 6.67:1. 
     As depicted in  FIG. 1A , the distal end (or distal portion) of the conformable foil-like substrate  300  comprises:
         two electrodes  200   a ,  200   b  of a first type, comprised in the first surface  310 , and   two electrodes  400   a ,  400   b  of a second type, also comprised in the first surface  310 . From proximal to distal end, the order depicted is  200   a ,  400   a ,  200   b ,  400   b —in other words, each electrode of the first type  200   a ,  200   b  is proximate an electrode of the second type  400   a ,  400   b  and comprised in the same surface  310 .       

     The foil-like substrate  300  comprises an electrical interconnection  250  between each electrode  200   a ,  400   a ,  200   b ,  400   b  and the pulse generator. In this embodiment, each electrical interconnection  250  is configured and arranged such that each electrode  200   a ,  400   a ,  200   b ,  400   b  is electrically connected substantially independently—consequently, one of the operating modes available by suitably configuring the pulse generator  500  is substantially independent operation. The pulse generator  500  may be configured using one or more hardware, firmware and/or software parameters. 
     Although depicted in  FIG. 1A  as individual connections  250  at different distances (or positions) between the first  310  and second  320  surfaces, the skilled person will also realize that the same interconnections may be provided by a suitably configured interconnections  250  (or an interconnection layer  250 ) at approximately the same distance (or position) between the first  310  and second  320  surfaces, similar to the embodiment depicted in  FIG. 3B , and described below. 
     “Comprised in” the first  310  or second  320  surface means that the electrodes  200   a ,  400   a ,  200   b ,  400   b  are relatively thin (such as when the substrate is arranged to conform to a substantially planar surface, it may have an extent along the second transverse axis of 20 to 50 microns or less Thinner electrodes may be also be used to further increase the degree of conformability, such as 1 micron or less), and attached to (or at least partially embedded in) the surface. 
     The electrodes  200 ,  400  may comprise a conductive material such as gold, platinum, platinum black, TiN, IrO 2 , iridium, and/or platinum/iridium alloys and/or oxides. Conductive polymers, such as Pedot, may also be used. Preferably, bio-compatible conductive materials are used. PCB/metallization techniques may be used to manufacture them on or in the first  310  and/or second  330  surfaces of the one or more polymeric substrate layers. 
     Thicker metal layers are generally preferred over thinner metal layers for electrodes  200   a ,  200   b ,  400   a ,  400   b  because they can be subjected to bodily substances that may dissolve the metal. However, thicker metal layers typically increase rigidity (reduce conformability) proximate the thicker layer. 
     The stimulator  100  may be implanted by first creating a subcutaneous tunnel and/or using an implantation tool. However, the high degree of conformability may make successful implantation more difficult. Even when using a suitable insertion tool, the electrode positions may be found later to be incorrect due to misalignment, lead migration during implantation, or lead migration after transplantation. 
     At least the distal end comprising the electrode array  200 ,  400 , is implanted. However, it may be advantageous to implant the stimulator  100 . 
     In addition, during implantation, it may be difficult to precisely identify the desired position for the stimulation. When implanted, the stimulator electrodes should be positioned sufficiently close to the nerve to be stimulated. But nerve pathways may not always be clearly visible to the professional performing the implantation, and the disposition and path of the nerve pathways vary greatly from person-to-person. 
     As depicted in  FIG. 1 , there is no substantial hardware difference between the first-type  200   a ,  200   b  and second type  400   a ,  400   b  electrodes—any difference in functionality is determined in this implementation mainly by the configuration (one or more hardware, firmware and/or software parameters) of the pulse generator  500 . There may be a smaller influence on the electrical properties due to the arrangement and routing of the interconnections  250 . 
     One or more coupled electrodes of the same type  200   a ,  200   b  or  400   a ,  400   b  may be operated substantially the same by suitable configuration of the pulse generator  500 —in other words, the stimulation energy applied to the electrodes  200 ,  400  is substantially the same at substantially the same time instance (usually measured as a voltage, a current, a power, a charge, or any combination thereof). This may also be used to anticipate and/or correct for a misalignment and/or lead migration—this is advantageous as it allows the configuration to be performed at least partially using software. 
     Additionally or alternatively, two or more electrodes  200 ,  400  may be configured and arranged using one or more parameters of the pulse generator  500  as a stimulation electrode or a return electrode. This may provide a higher degree of configurability as it only becomes necessary to implant the substrate  300  such that at least two of the electrodes are proximate the desired stimulation location. 
     In this embodiment  100 , the electrodes of the first type  200   a ,  200   b  are nominally configured and arranged to be operated as a stimulation electrode. 
     The electrodes of the second type  400   a ,  400   b  are nominally configured to be operated as a return electrode—each is configured to provide, in use, an electrical return for one or more stimulation electrode  200   a ,  200   b . In other words, the electrical return  400   a ,  400   b  closes the electrical circuit. It may also be similarly configured to provide an electrical ground for a corresponding electrical energy source. 
     Three configurations are thus provided based on this nominal configuration: either:
         a stimulation/return electrode pair  200   a / 400   a  proximate the first surface  310  at that stimulation/return location; or   a stimulation/return electrode pair  200   b / 400   b  proximate the first surface  310  at that stimulation/return location; or   a combination thereof.       

     In an embodiment, one or more stimulation electrodes  200   a ,  200   b  may be provided in such a stimulator  100 . The number, dimensions and/or spacings of the stimulating electrodes  200   a ,  200   b  may be selected and optimized depending on the treatment. In an embodiment, if more than one stimulation electrode  200   a ,  200   b  is provided, each stimulation electrode  200   a ,  200   b  may provide:
         a different stimulation effect, a similar stimulation effect or the same stimulation effect.       

     To avoid a misalignment, a selection may be made of one or two electrodes  200   a ,  200   b  proximate the tissues where the effect is to be created. 
     Two or more stimulation electrodes  200   a ,  200   b  may be made active at substantially the same time if stimulation over a larger area is required and/or at a location between the active stimulation electrodes  200   a ,  200   b.    
     In an embodiment, a stimulation electrode  200   a ,  200   b  may have dimensions in the order of six to eight mm along the longitudinal axis  600 , and three to five mm along the first transverse axis  700 , so approximately 18 to 40 square mm (mm 2 ). 
     In an embodiment, a foil-like substrate  300 , suitable for an implantable stimulator, may comprise up to twelve stimulation  200   a ,  200   b  and return  400   a ,  400   b  electrodes over a length of 15 cm to allow for a correction for misalignment, or to simply allow the specialist to select the most effective stimulation location. 
     In an embodiment,  FIG. 1B  depicts a view of the second surface  320  of the implantable distal end (or portion) of the foil-like substrate  300  depicted in  FIG. 1A . In other words, the second surface  320  is depicted in the plane of the paper, lying along the longitudinal axis  600  (depicted from bottom to top) and in the first transverse axis  700  (depicted from left to right). The second transverse axis  750  extends into the page. The first surface  310  is not depicted in  FIG. 1B , but lies at a higher position along the second transverse axis  750  (into the page), and is also substantially parallel to the plane of the drawing. The foil-like substrate  300  is arranged to conform to a substantially planar surface. 
     The pulse generator  500  may be disposed (or positioned) between the second  320  surface and the first  310  surface. In  FIGS. 1B and 1C , it is depicted with dotted lines. Alternatively, the pulse generator  500  may be at least partially disposed on the first surface  310  or on the second surface  320 . Alternatively, the pulse generator  500  may be at least partially embedded in the first surface  310  or in the second surface  320 . 
     Depending on the degree of embedding and the one or more electrical components used for the pulse generator  500 , the maximum thickness may be optimized. Components may be thinned to minimize the thickness. If the substrate  300  is configured and arranged to be conformable and/or foil-like, the maximum thickness of the implantable stimulator  100  in a portion of the substrate proximate the pulse generator  500  may be five millimeters or less, preferably four millimeters or less, even more preferably three millimeters or less, the thickness being determined by a perpendicular distance between corresponding points on outer planar surfaces when the implantable stimulator  100  conforms to a substantially planar surface. Additional optional electrical components, such as an antenna, comprising a coil or dipole or fractal antenna, may also influence the thickness depending on the degree that they are embedded in the substrate. 
     The stimulator  100  and the foil-like substrate  300  extend along the first transverse axis  700  (considered the planar width of the stimulator  100 /foil-like substrate  300  when conforming to a substantially planar surface). As depicted, the planar width in a portion of the substrate proximate the pulse generator  500  may be greater than the planar width in another portion of the substrate proximate the electrodes  200   a ,  200   b ,  400   a ,  400   b  at the distal end (or portion) of the foil-like substrate  300 . The planar width proximate the pulse generator  500  may depend on the hardware and components used for the pulse generator  500 —typically, it is at least the width of the integrated circuit used for the pulse generator  500 . Additional optional electrical components, such as an antenna comprising a coil or dipole or fractal antenna, may also influence the planar width. 
     In an embodiment, the planar width proximate the electrodes  200   a ,  200   b ,  400   a ,  400   b  may depend on the conductors used for the electrodes  200   a ,  200   b ,  400   a ,  400   b  and the one or more interconnections  250 . In an embodiment, the planar width is at least the width of the first electrode  200   a ,  200   b  or the second electrode  400   a ,  400   b.    
     In an embodiment,  FIG. 1C  depicts a view of the first surface  310  of the implantable distal end (or portion) of the foil-like substrate  300  depicted in  FIGS. 1A and 1B . In other words, the first surface  310  is depicted in the plane of the paper, lying along the longitudinal axis  600  (depicted from bottom to top) and in the first transverse axis  700  (depicted from right to left). The second transverse axis  750  extends out of the page. This is the view facing the animal or human tissue which is stimulated (in use). The second surface  320  is not depicted in  FIG. 1C , but lies at a lower position along the second transverse axis  750  (into the page), and is also substantially parallel to the plane of the drawing. The foil-like substrate  300  is arranged to conform to a substantially planar surface. 
     The one or more interconnections  250  are disposed (or positioned) between the first  310  surface and the second  320  surface, as depicted in  FIG. 1A . In  FIG. 1C , they are depicted as dotted lines, representing the interconnections  250  (or suitably configured one or more interconnection layers  250 ) that have been provided for each of the electrodes  200   a ,  200   b ,  400   a ,  400   b  in this embodiment. A single dotted line  250  is depicted between the pulse generator  500  and the electrodes  200 ,  400  to indicate, in embodiment  100 , that the interconnections  250  are at approximately the same disposition along the first transverse axis  700 . 
     As depicted in  FIG. 1C , the electrodes  200   a ,  200   b ,  400   a ,  400   b  each have a longitudinal extent (length) along the longitudinal axis  600  and a transverse extent (width) along the first transverse axis  700 . 
     Although depicted as similar, in practice, each electrode  200   a ,  200   b ,  400   a ,  400   b  may vary in shape, transverse cross-section, orientation and/or size (or extent), depending on the intended use and/or the desired degree of configurability. 
     After implantation of the stimulator  100 , or at least of the distal end (or portion) comprising the electrode array  200 ,  400 , the pulse generator  500  may be configured and arranged to provide, in use, electrical energy to the one or more coupled electrodes of the first type  200   a ,  200   b  with respect to the electrical return applied to the one or more coupled electrodes of the second type  400   a ,  400   b.    
     The configurability of the stimulator  100  allows, before, during and/or after implantation of at least of the distal end (or portion) comprising the electrode array  200 ,  400 , the operation of the one or more electrodes  200   a ,  200   b ,  400   a ,  400   b  to be determined and/or adapted. The operation may also be reconfigured one or more times during the period that the stimulator  100  is implanted to optimize and/or prolong treatment. 
     In an embodiment, the pulse generator  500  may be initially configured to nominally operate  200   a  and  400   a  as respectively a stimulation/return electrode pair. After implantation of at least the distal end  200 ,  400 , insufficient stimulation may be observed and/or measured. If it is assumed to be due to a mainly longitudinal misalignment, the pulse generator  500  may be alternatively configured, using one or more parameters, to nominally operate  200   b  and  400   b  as respectively a stimulation/return electrode pair. 
     The stimulator  100  may be further configured and arranged to switch the pulse generator  500  under predetermined and/or controlled conditions between these configurations. It may be convenient to further consider these configurations as a first and second electrode modes, and allow a user to select a mode as a preference and/or switch mode. Alternatively, the pulse generator  500  may switch modes under predetermined and/or controlled conditions. 
     Additionally or alternatively, other modes may also be provided for configuring the pulse generator  500  to operate in:
         a first electrode mode, wherein electrical stimulation energy is provided to one or more coupled electrodes of the first type  200   a ,  200   b  as one or more electrical treatment stimulation pulses, the one or more coupled electrodes of the second type  400   a ,  400   b  being configured to provide, in use, a corresponding electrical return for the one or more first electrodes  200   a ,  200   b ; or   a second electrode mode, wherein energy is provided to one or more coupled electrodes of the second type  400   a ,  400   b  as one or more electrical treatment stimulation pulses, the one or more coupled electrodes of the first type  200   a ,  200   b  being configured to provide, in use, a corresponding electrical return for the one or more second electrodes  400   a ,  400   b.          

     Again, the stimulator  100  may be further configured and arranged to switch the pulse generator  500  under predetermined and/or controlled conditions between these configurations or modes. Additionally or alternatively, a user may be allowed to select a mode as a preference and/or switch mode. 
     The skilled person will realize that the electrodes  200   a ,  200   b ,  400   a ,  400   b  may be configured to operate in more complex configurations, such as:
           400   a  and  200   a  may be operated as respectively a stimulation/return electrode pair (reversing the original intended operation);     400   b  and  200   b  may be operated as respectively a stimulation/return electrode pair;   if an intermediate stimulation is preferred, two or more electrodes  200   a ,  200   b ,  400   a ,  400   b  may be operated substantially simultaneously as one or more stimulation electrodes;   one or more electrodes  200   a ,  200   b ,  400   a ,  400   b  may be operated as one or more return electrodes;   electrode  400   a  operated as a stimulation electrode, in combination with electrode  200   a  and electrode  200   b  as return electrodes;   electrode  400   a  and  200   b  operated as a stimulation electrode, in combination with electrode  200   a  and electrode  400   b  as a return electrode.       

     Alternatively or additionally, the shape, orientation, transverse cross-section, and/or size (or length) of one or more stimulation electrodes may be differently configured compared to one or more return electrodes. 
     A number of parameters and properties may be considered when configuring and arranging a portion of the foil-like substrate  300  proximate the electrode array  200 ,  400  for conformability, such as:
         the transverse  700  and/or longitudinal extent  600  of the one or more electrodes  200   a ,  200   b ,  400   a ,  400   b      the thickness of the foil-like substrate  300 , or the perpendicular distance between the first surface  310  and the second surface  320     the materials comprised in the foil-like substrate  300 , and their physical properties   the number and extent of interconnections  250  and/or interconnection layers  250  between the first surface  310  and second surface  320 .       

     There have been attempts to make traditional leads, such as cylindrical leads, much thinner to allow subcutaneous implantation and/or to increase comfort by flattening. But the surface area of the flattened electrodes may become disadvantageously small. 
     In a non-limiting example, a conventional 0.2 mm round lead with 1 cm long electrodes is estimated to result in an electrode with approximately 6 mm 2  electrode surface. 
     However, using the conformable electrode arrays described herein, a thin substrate  300  with dimensions of 0.2 mm thick, and four mm wide may be configured and arranged to provide approximately 35 mm 2  electrode surface in the same length. It is estimated that this may reduce impedance by a factor of approximately 35/6, and reduce power consumption by approximately 35/6. 
     In an embodiment,  FIGS. 2A, 2B and 2C  depict longitudinal cross-sections through a second embodiment  101  of an implantable stimulator. It is similar to the first embodiment  100 , depicted in  FIGS. 1A, 1B and 1C  except:
         instead of four electrodes comprised in the first surface  310 , this embodiment comprises two electrodes in the first surface  310 —nominally an electrode of the first type  200   a  and nominally an electrode of the second type  400   a . From proximal to distal end, the order depicted is  200   a ,  400   a —in other words, an electrode of the first type  200   a  is proximate an electrode of the second type  400   a  in the first surface  310 .   the distal end of the stimulator  101  also comprises two electrodes in the second surface  320 —a further electrode nominally of the first type  200   b  and a further electrode nominally of the second type  400   b . From proximal to distal end, the order depicted is  200   b ,  400   b —in other words, an electrode of the first type  200   b  is proximate an electrode of the second type  400   b  in the second surface  320 .   In  FIG. 2B , the view of the second surface  320  depicts the two electrodes  200   a ,  400   a  comprised in that surface, and one or more interconnections  250  are depicted using a dotted line;   In  FIG. 2C , the view of the second surface  320  depicts the two electrodes  200   b ,  400   b  comprised in that surface, and one or more interconnections  250  are depicted using a dotted line;       

     In this embodiment  101 , the electrodes of the first type  200   a ,  200   b  are nominally configured and arranged to be operated as a stimulation electrode, and the electrodes of the second type  400   a ,  400   b  are nominally configured to be operated as a return electrode. 
     Three main configurations are thus provided:
         a stimulation/return electrode pair  200   a / 400   a  proximate the first surface  310 ; or   a stimulation/return electrode pair  200   b / 400   b  proximate the second surface  320 ; or   a combination thereof.       

     This may be advantageous if it is uncertain whether the implantable distal end of the foil-like substrate  300  may be “above” or “below” the targeted tissue such as “above” or “below” a nerve. This may be determined after implantation by attempting stimulation in each nominal configuration and observing and/or measuring the presence of neural stimulation. 
     As discussed above, in relation to  FIGS. 1A, 1B and 1C , each electrode  200   a ,  200   b ,  400   a ,  400   b  may be operated as one or more stimulation electrodes or operated as one or more return electrodes. 
     In an embodiment,  FIGS. 3A, 3B and 3C  depict longitudinal cross-sections through a third embodiment  102  of an implantable stimulator. It is similar to the second embodiment  101 , depicted in  FIGS. 2A, 2B and 2C  except:
         interconnections  250  are disposed at approximately the same disposition along the second transverse axis  750 , as depicted in  FIG. 3A . The lines  250  are hatched to indicate that they are not be depicted as being in the same longitudinal cross-section—there are interconnections  250  disposed at substantially different positions along the first transverse axis  700 ;   interconnections  250  are disposed at substantially different dispositions along the first transverse axis  700 , as depicted in  FIGS. 3B and 3C  as two adjacent dashed lines between the electrode array  200 ,  400  and the pulse generator  500 ;   instead of nominally comprising an electrode of the first  200  and second type  400  in the first surface  310 , the first surface  310  comprises a first  200   a  and second  200   b  electrode nominally of the first type  200 ;   instead of nominally comprising an electrode of the first  200  and second type  400  in the second surface  320 , the second surface  320  comprises a first  400   a  and second  400   b  electrode nominally of the second type  400 ;       

     In this embodiment  102 , the electrodes of the first type  200   a ,  200   b  are nominally configured and arranged to be operated as a stimulation electrode, and the electrodes of the second type  400   a ,  400   b  are nominally configured to be operated as a return electrode. 
     Three main configurations are thus provided:
         a stimulation/return electrode pair  200   a / 400   a  for stimulating between the first surface  310  and second surface  320  proximate the location of this electrode pair; or   a stimulation/return electrode pair  200   b / 400   b  for stimulating between the first surface  310  and second surface  320  proximate the location of the electrode pair; or   a combination thereof.       

     This may be advantageous to correct for a longitudinal misalignment, or to simply allow the healthcare professional to select the most effective stimulation location. 
     As discussed above, in relation to  FIGS. 2A, 2B and 2C , each electrode  200   a ,  200   b ,  400   a ,  400   b  may be operated as one or more stimulation electrodes or operated as one or more return electrodes. 
     Additionally or alternatively, one or more electrodes of the same type  200   a ,  200   b  or  400   a ,  400   b  may be electrically connected to each other by suitably configuring the one or more interconnections  250 . They will then be operated substantially the same. This may be used to anticipate and/or correct for a misalignment and/or lead migration as longitudinal positioning is less sensitive (a stimulation is provided over a greater longitudinal and or transverse extent). 
       FIGS. 4A, 4B and 4C  depict alternative electrode array  200 ,  400  configurations suitable for being comprised in an implantable stimulator  100 ,  101 ,  102  as described herein. 
       FIG. 4A  depicts an implantable distal end of a further embodiment  103  of a stimulator. Similar to the distal end depicted in  FIG. 1C , the first surface  310  comprises:
         two electrodes  200   a ,  200   b  of a first type and two electrodes  400   a ,  400   b  of a second type. From proximal to distal end, the order depicted is  200   a ,  400   a ,  200   b ,  400   b —in other words, each electrode of the first type  200   a ,  200   b  is proximate an electrode of the second type  400   a ,  400   b  and comprised in the same surface  310 .       

     The distal end depicted in  FIG. 4A  is the same as that depicted in  FIG. 1A , except:
         the electrodes  200 ,  400  are extended at angle to the longitudinal axis  600 . This may reduce the sensitivity to longitudinal misalignment because the longitudinal locations over which tissue stimulation may be provided are increased.       

     Additionally or alternatively, the second surface  320  may similarly comprise two electrodes  200   a ,  200   b  of the first type and two electrodes  400   a ,  400   b  of the second type. 
     As discussed above, each electrode  200   a ,  200   b ,  400   a ,  400   b  may be operated as one or more stimulation electrodes or operated as one or more return electrodes. 
       FIG. 4B  depicts an implantable distal end of a further embodiment  104  of a stimulator. Similar to the distal end depicted in  FIG. 1C , the first surface  310  comprises four electrodes. However, in this embodiment  104 , the first surface  310  comprises:
         four electrodes  200   a ,  200   b ,  200   c ,  200   d  of a first type and an electrode  400  of a second type. From proximal to distal end, the order depicted is  200   a ,  200   b ,  200   c ,  200   d . Transversely adjacent to the four electrodes of the first type  200  is an electrode of the second type  400 , extending longitudinally to be adjacent to each electrode of the first type  200 .       

     Nominally, the electrodes of the first type  200  may be operated as one or more stimulation electrodes. The electrode of the second type  400  may be nominally operated as a return electrode for one or more of the stimulation electrodes. 
     This may reduce the sensitivity to longitudinal misalignment because the four different longitudinal locations are provided which may be selected for stimulation over which tissue stimulation may be provided are increased. 
     Additionally or alternatively, the second surface  320  may similarly comprise four electrodes  200   a ,  200   b ,  200   c ,  2003  of the first type and one adjacent and longitudinally extended electrode  400  of the second type. 
     As discussed above, each electrode  200   a ,  200   b ,  200   c ,  200   d ,  400  may be operated as one or more stimulation electrodes or operated as one or more return electrodes. 
       FIG. 4C  depicts an implantable distal end of a further embodiment  105  of a stimulator. Similar to the distal end depicted in  FIG. 4B , the first surface  310  comprises four electrodes  200   a ,  200   b ,  200   c ,  200   d  of a first type. However, in this embodiment  105 , the first surface  310  further comprises four adjacent electrodes  400   a ,  400   b ,  400   c ,  400   d  of a second type. From proximal to distal end, the order depicted is  200   a / 400   a ,  200   b / 400   b ,  200   c / 400   c ,  200   d / 400   d . Transversely adjacent to each of the four electrodes of the first type  200  is an electrode of the second type  400  at approximately the same disposition along the longitudinal axis  600 . 
     Nominally, the electrodes of the first type  200  may be operated as one or more stimulation electrodes. The electrodes of the second type  400  may be nominally operated as a return electrode for one or more of the stimulation electrodes. Nominally, adjacent electrodes may be considered as a stimulation/return pair  200 / 400 . 
     In other words, a 2×4 electrode array is provided—two along a transverse axis and four along the longitudinal axis. 
     This may reduce the sensitivity to longitudinal misalignment because the four different stimulation/return  200 / 400  pairs are provided at substantially different longitudinal locations are provided which may be selected for stimulation over which tissue stimulation may be provided are increased. 
     Additionally or alternatively, the second surface  320  may similarly comprise four electrodes  200   a ,  200   b ,  200   c ,  200   d  of the first type and four adjacent electrodes  400   a ,  400   b ,  400   c ,  400   d  of the second type. 
     As discussed above, each electrode  200   a ,  200   b ,  200   c ,  200   d ,  400   a ,  400   b ,  400   c ,  400   d  may be operated as one or more stimulation electrodes or operated as one or more return electrodes. This may also reduce the sensitivity to a transverse misalignment. 
     The stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105  may further comprise:
         an energy receiver, configured and arranged to wirelessly receive energy from an associated energy transmitter when the associated energy transmitter is proximate;   the pulse generator  500  being further configured and arranged to receive electrical energy from the energy receiver for its operation.       

       FIG. 5  and  FIG. 6  depict configurations of nerves that may be stimulated using a suitably configured implantable distal end of stimulators  100 ,  101 ,  102 ,  103 ,  104 ,  105  to provide neurostimulation to treat conditions such as headaches or primary headaches. 
       FIG. 5  depicts the left supraorbital nerve  910  and right supraorbital nerve  920  which may be electrically stimulated using a suitably configured device.  FIG. 6  depicts the left greater occipital nerve  930  and right greater occipital nerve  940  which may also be electrically stimulated using a suitably configured device. 
     Depending on the size of the region to be stimulated and the dimensions of the part of the device to be implanted, a suitable location is determined to provide the electrical stimulation required for the treatment. Approximate implant locations for the distal part of the stimulation device comprising stimulation devices  100 ,  101 ,  102 ,  103 ,  104 ,  105  are depicted as regions:
         location  810  for left supraorbital stimulation and location  820  for right supraorbital stimulation for treating chronic headache such as migraine and cluster.   location  830   a  or  830   b  for left occipital stimulation and location  840   a  or  840   b  for right occipital stimulation for treating chronic headache such as migraine, cluster, and occipital neuralgia. Locations  830   b ,  840   b  for stimulation are located superior (“above”) to the (external) occipital protuberance inion.       

     In many cases, these will be the approximate locations  810 ,  820 ,  830   a/b ,  840   a/b  for the implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 . 
     For each implant location,  810 ,  820 ,  830   a/b ,  840   a/b  a separate stimulation system may be used. Where implant locations  810 ,  820 ,  830   a/b ,  840   a/b  are close together, or even overlapping, a single stimulation system may be configured to stimulate at more than one implant location  810 ,  820 ,  830   a/b ,  840   a/b.    
     A plurality of stimulation devices  100 ,  101 ,  102 ,  103 ,  104 ,  105  may be operated separately, simultaneously, sequentially or any combination thereof to provide the required treatment. 
       FIG. 7  depict further configurations of nerves that may be stimulated using a suitably configured improved implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105  to provide neurostimulation to treat other conditions. The locations depicted in  FIG. 5  and  FIG. 6  ( 810 ,  820 ,  830 ,  840 ) are also depicted in  FIG. 7 . 
     Depending on the size of the region to be stimulated and the dimensions of the part of the device to be implanted, a suitable location is determined to provide the electrical stimulation required for the treatment. Approximate implant locations for the part of the stimulation device comprising stimulation electrodes are depicted as regions:
         location  810  for cortical stimulation for treating epilepsy;   location  850  for deep brain stimulation for tremor control treatment in Parkinson&#39;s disease patients; treating dystonia, obesity, essential tremor, depression, epilepsy, obsessive compulsive disorder, Alzheimer&#39;s, anxiety, bulimia, tinnitus, traumatic brain injury, Tourette&#39;s, sleep disorders, autism, bipolar; and stroke recovery   location  860  for vagus nerve stimulation for treating epilepsy, depression, anxiety, bulimia, obesity, tinnitus, obsessive compulsive disorder, heart failure, Crohn&#39;s disease and rheumatoid arthritis;   location  860  for carotid artery or carotid sinus stimulation for treating hypertension;   location  860  for hypoglossal &amp; phrenic nerve stimulation for treating sleep apnea;   location  865  for cerebral spinal cord stimulation for treating chronic neck pain;   location  870  for peripheral nerve stimulation for treating limb pain, migraines, extremity pain;   location  875  for spinal cord stimulation for treating chronic lower back pain, angina, asthma, pain in general;   location  880  for gastric stimulation for treatment of obesity, bulimia, interstitial cystitis;   location  885  for sacral &amp; pudendal nerve stimulation for treatment of interstitial cystitis;   location  885  for sacral nerve stimulation for treatment of urinary incontinence, fecal incontinence;   location  890  for sacral neuromodulation for bladder control treatment; and   location  895  for fibular nerve stimulation for treating gait or footdrop.       

     Other conditions that may be treated include gastro-esophageal reflux disease, an autoimmune disorder, inflammatory bowel disease and inflammatory diseases. 
     The conformability and reduced thickness of the substrate  100  and electrode array  200 ,  400  makes one or more implantable stimulators  100 ,  101 ,  102 ,  103 ,  104 ,  105  highly advantageous for the stimulation of one or more nerves, one or more muscles, one or more organs, spinal cord tissue, brain tissue, one or more cortical surface regions, one or more sulci, and any combination thereof. 
     The implantable stimulators  100 ,  101 ,  102 ,  103 ,  104 ,  105  described above in relation to  FIG. 1  to  FIG. 4  may be generally described as embodiments configured and arranged for improved conformance. 
     The stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105  may be further modified. In a non-limiting example:
         a portion of the foil-like substrate  300  and pulse generator  500  may be embedded in one or more flexible bio-compatible encapsulation layers, such as those described below. These layers may comprise: a Liquid Crystal Polymer (LCP), a Polydimethylsiloxane (PDMS), a silicone polyurethane, a Polyimide, a parylene, a biocompatible polymer, a biocompatible elastomer, and any combination thereof.       

     The implantable electrical devices  1100 ,  1101 ,  1102  described below in relation to  FIG. 8  to  FIG. 12  may be generally described as embodiments configured and arranged for improved encapsulation. As described below, they may be comprised in an implantable medical device  1110 ,  1111  configured and arranged to provide a degree of stimulation. 
       FIG. 11A  depicts a cross-section through an improved implantable electrical or electronic device  1100 . It comprises:
         a substrate  1400  having a first surface  1410  and one or more electrical conductors  1210 .       

     Optionally, the substrate  1400  may be substantially biocompatible—however, the use of one or more encapsulation layers  1310  may allow substrates  1400  and electrical conductors  1210  which are not biocompatible, partially biocompatible, or significantly biocompatible, to be used. 
     In general, the degree of biocompatibility of a material or layer may be determined by measuring the degree of tissue reaction and the length of period during which it is considered biostable. A low degree of tissue reaction and/or long period of biostability indicates a high degree of biocompatibility. 
     The substrate  1400  is further configured and arranged to be substantially flexible—in other words, the substrate is pliant or flexible or compliant (or conformable) to a substantial degree. The degree of flexibility may be adapted using parameters, such as:
         dimensioning of the device  1100  elements, and/or   inclusion of materials and substances with desired properties, and/or   combinations of materials and substances used, and/or   percentages of materials and substances used, and/or   inclusion of recesses, openings, apertures, reinforcement.       

     Additionally or alternatively, the skilled person will realize that the degree of flexibility may be adapted using parameters described above for the substrate  300  described in relation to  FIG. 1  to  FIG. 4 . 
     The one or more electrical conductors  1210  are depicted very schematically—they may be conductors embedded in or deposited onto the substrate  1400 —for example, by having a single polymer layer and applying conductive material using suitable deposition techniques known from the semiconductor industry. The one or more conductors  1210 , such as a metal, may be formed as required—for example, in one or more conductive elements: wire, strand, foil, lamina, plate, and/or sheet. Optionally, the one or more conductors may be positioned between the outer surfaces of the substrate  1400 ; 
     The device  1100  further comprises:
         a first biocompatible encapsulation layer  1310  comprising a polydimethylsiloxane (PDMS) rubber; and   a first adhesion layer  1510 ,       

     In the context of this disclosure, a ceramic should be considered as an advanced ceramic and/or an industrial ceramic, providing a relatively high degree of thermal stability, wear-resistance and resistance to corrosion. 
     The most suitable ceramic materials are those with a high degree of adhesion to the encapsulant layer and/or substrate, and capable of being applied in a relatively uniform coating to provide a relatively low degree of permeability to moisture. A ceramic material in this context may be an inorganic, non-metallic or metallic, often crystalline oxide, nitride or carbide material. Some elements, such as carbon or silicon, are also considered ceramics. A non-metallic ceramic may comprise both non-metallic and metallic elements. 
     Optionally, the first adhesion layer  1510  may be substantially biocompatible—however, the use of one or more encapsulation layers  1310  may allow one or more adhesion layers  1510  which are not biocompatible, partially biocompatible, or significantly biocompatible, to be used. 
     The first adhesion layer  1510  and the first encapsulation layer  1310  are configured and arranged to resist the ingress of fluids from a human or animal body into at least a portion of the first surface  1410 . The configuration and arrangement are further described below. 
     As depicted in  FIG. 11A , the extent of the adhesion/encapsulation layer  1510 / 1310  in this cross-section may be less than the extent of the substrate  1400 . In general, the extent of the adhesion/encapsulation layer  1510 / 1310  may be larger than, equal to or less than the extent of the substrate  1400 . A “larger than” embodiment for the adhesion and encapsulation layers is depicted in  FIG. 11C . Further “less than” embodiments for the adhesion and encapsulation layers are depicted in  FIG. 11B  and  FIG. 12A . 
     In general, the portion of the first surface  1410  being protected against ingress of fluids is equal to or less than the extent of the adhesion/encapsulation layer  1510 / 1310 . 
     As depicted in  FIG. 11A , the extent of the adhesion layer  1510  in this cross-section may be less than the extent of the encapsulation layer  1310 —in some configurations, this may be advantageous as the edges of the adhesion layer  1510  are at least partially encapsulated  1310 . In general, the extent of the adhesion layer  1510  may be larger than, equal to or less than the extent of the encapsulation layer  1310 . Further “less than” embodiments are depicted in  FIG. 11C  and  FIG. 12A . An “equal to” portion of a substrate is depicted in  FIG. 12B . 
     In a preferred embodiment, the extent of the adhesion layer  1510  is equal to or larger than the extent of the encapsulation layer  1310 —this may be advantageous in certain configurations as the surface area of encapsulant  1310  in direct contact with the surface  1410  of the substrate  1400  is greatly reduced. In some cases, this surface area may be substantially zero, further reducing the possibility of fluid ingress. A “substantially zero” embodiment is depicted in  FIG. 11C  and a portion of a substrate depicted in  FIG. 12B . 
       FIG. 11B  depicts another implantable electrical or electronic device  1101 . It is the same as the implantable electrical device  1100  depicted in  FIG. 11A , except for further comprising:
         a second surface  1420 ;   a second biocompatible encapsulation layer  1320 , comprising a polydimethylsiloxane (PDMS) rubber; and   a second adhesion layer  1520 , comprising a ceramic material, disposed between the second planar surface  1420  and the second encapsulation layer  1320 . The second adhesion layer  1520  is further configured and arranged to conform to the second surface  1420 —in other words, it is a conformal layer.       

     The second adhesion layer  1520  and the second encapsulation layer  1320  are configured and arranged to resist the ingress of fluids from a human or animal body into at least a portion of the second surface  1420 . The configuration and arrangement are further described below. 
     The second encapsulation layer  1320  may be substantially identical, similar to a high degree or substantially different to the first encapsulation layer  1310 . 
     The second adhesion layer  1520  may be substantially identical, similar to a high degree or substantially different to the first adhesion layer  1510 . 
     Although the first surface  1410  and second surface  1420  are depicted as opposite faces of a substrate in  FIG. 11B , other combinations are possible, such as:
         applying the first adhesion/encapsulation layer  1310 / 1510  and the second adhesion/encapsulation layer  1320 / 1520  to different regions of the first surface  1410 ;   applying the first adhesion/encapsulation layer  1310 / 1510  and the second adhesion/encapsulation layer  1320 / 1520  to different regions of the second surface  1420 ;   the first surface  1410  and second surface  1420  being adjacent to each other;   the first surface  1410  and second surface  1420  being opposite to each other;   the first surface  1410  and second surface  1420  being at a predetermined angle to each other;   the first surface  1410  and second surface  1420  being substantially perpendicular to each other.       

       FIG. 11C  depicts a further implantable electrical or electronic device  1102 . It is the same as the implantable electrical device  1100  depicted in  FIG. 11A , except in this cross-section:
         the substrate  1400  comprises four protected surfaces, each surface being protected by a further adhesion layer  1500  and a further encapsulation layer  1300 ;   the extent of the further adhesion layer  1500  is larger than the extent of substrate  1400  for each protected surface;   the extent of the further encapsulation layer  1300  is larger than the extent of the substrate  1400  for each protected surface; and   the extent of the further adhesion layer  1500  is less than the extent of the encapsulation layer  1300  for each protected surface.       

     Functionally, it may also be considered that the further encapsulation layer  1300  comprises the first  1310  and second  1320  encapsulation layers depicted in  FIG. 11B . 
     Functionally, it may also be considered that the further adhesion layer  500  comprises the first  1510  and second  1520  adhesion layers depicted in  FIG. 11B . 
     Functionally, it may also be considered that the substrate  1400  depicted in  FIG. 11C  comprises the protected portions of the first  1410  and second  1420  surfaces depicted in  FIG. 11B . However, the substrate  1400  depicted in  FIG. 11C , comprises two or more further protected surfaces, adjacent to such a protected first or second surface. 
     The further encapsulation layer  1300  of  FIG. 11C  may be substantially identical, similar to a high degree or substantially different to the first encapsulation layer  1310  depicted in  FIG. 11A or 11B . The further encapsulation layer  1300  of  FIG. 11C  may be substantially identical, similar to a high degree or substantially different to the second encapsulation layer  1320  depicted in  FIG. 11B . 
     The further adhesion layer  1500  of  FIG. 11C  may be substantially identical, similar to a high degree or substantially different to the first adhesion layer  1510  depicted in  FIG. 11A or 11B . The further adhesion layer  1500  of  FIG. 11C  may be substantially identical, similar to a high degree or substantially different to the second adhesion layer  1520  depicted in  FIG. 11B . 
     The further embodiment  1102  may be advantageous because:
         the portion of the surfaces of the substrate  1400  being protected against ingress of fluids is less than the extent of the further encapsulation layer  1300 ;   the edges of the further adhesion layer  1500  are substantially encapsulated  1300 ; and   the surface area of encapsulant  1300  in direct contact with a surface of the substrate  1400  is close to or substantially zero.       

     Experiments were performed to establish the suitability of a specific adhesion layer  1510 ,  1520  to provide a high degree of bonding to a PDMS. 
     A. Sample Preparation 
       FIG. 10  depicts a cross-section through the test sample  1130   
     1) IDC Using Pt Metallization 
     Interdigitated capacitors (IDC)  1230  were used to evaluate encapsulation performance—approximately 600 nm of Pt (Platinum) was sputtered on top of a 1 μm (1 micron) thick plasma enhanced chemical vapor deposition (CVD) SiO2 layer  1435  with an intermediate 10 nm titanium adhesion layer. More details on these IDC  1230  are found in “Silicone rubber encapsulation for an endoscopically implantable gastrostimulator”, Lonys, Vanhoestenberghe, Julemont, Godet, Delplancke, Mathys and Nonclercq, Med. Biol. Eng. Comput. 53 319-29, 2015. The SiO2 layer  1435  was provided on a silicon substrate  1430 . 
     2) ALD Coating 
     Atomic layer deposition (ALD) is a coating process that may be used to create nm-thick conformal coatings. The ALD coating was applied using the PICOSUN® R-200 Advanced ALD reactor under reduced pressure (N2 atmosphere) of about 1 mbar (1 hPa). 
     The R-200 Advanced, from Picosun Oy, Finland, provides very high quality ALD film depositions. It is suggested by the manufacturer as suitable for depositions including: Al2O3, TiO2, SiO2, Ta2O5, HfO2, ZnO, ZrO2, AlN, TiN, metals such as Pt or Ir. 
     It comprises a remote microwave plasma generator, with adjustable 300-3000 W power, 2.45 GHz frequency, mounted to the loading chamber and connected to the reaction chamber. Up to twelve sources with six separate inlets may be used—seven if the plasma option is chosen. The precursor sources may comprise liquid, gaseous and/or solid chemicals. Precursors may also include ozone and/or plasma. The remote plasma option allows deposition of metals with a greatly reduced risk of short-circuiting and/or plasma damage. The processing temperature may in general be 50-500° C. Plasma may generally be used up to approximately 450° C., or up to approximately 650° C. with a heated sample holder. 
     It comprises a hot-wall and substantially separate inlets and instrumentation providing a relatively low particle (or substantially particle-free) processing adaptable on a wide range of materials on wafers, 3D objects, and nanoscale features. It provides a high degree of uniformity, even on porous, through-porous, high aspect ratio (up to 1:2500), and nanoparticle samples using their proprietary Picoflow™ diffusion enhancer. This enhancer provides a protective gas flow in an intermediate space to greatly reduce back-diffusion of the plasma species. 
     A suitable ALD process, for forming a monolayer comprising a first and second element, may comprise:
         loading a substrate as a sample into a reaction space;   introducing a quantity of first molecules comprising the first element into the reaction space whereby at least a first portion of the first molecules adsorb to a surface of the substrate; and   introducing a quantity of second molecules comprising the second element into the reaction space whereby at least a second portion of the second molecules reacts with the first portion on the surface of the substrate to form a monolayer of a compound comprising the first and second element.       

     Using the Picohot™ source system (PH-300) and PicoSolution options for the R-200 Advanced, precursors were vaporized from stainless-steel precursor bottles at increased temperature and at room temperature. The Picohot™ 300 source system allows source heating up to 300 degr. C, and is suggested by the manufacturer to be suitable with source chemicals having a vapor pressure of at least 2 mbar at source temperature. The Picosolution™ 600 source system allows liquid precursors to be used, and are suggested by the manufacturer to be suitable with source chemicals having a vapor pressure of at least 10 mbar at source temperature. 
     Thermal ALD-processes at 200 degr. C were applied with layer-by-layer deposition method where the two different precursor materials (separated by N2 purge to remove surplus molecules from the reaction space) were used to build up a HfO2 (hafnium dioxide) coating  1530 —this is depicted in  FIG. 10  as a coating  1530  substantially covering the external surfaces of the substrate  1430 ,  1435  and the IDC sensors  1230 . 
     An optional stabilization time of approximately 90 minutes was used at 200 degr. C. Ten layers of approximately 5 nm were applied to provide an ALD layer of approximately 50 nm. 
     It is believed that ALD may be advantageous to create an ultra-thin conformal coating with low defects and/or reduced pinhole formation. Also, the deposition temperature for ALD may be kept below 200° C. which is advantageous for devices incorporating sensitive metallization and/or polymers. 
     3) PDMS Encapsulation 
     Samples were encapsulated with a layer comprising a substantially biocompatible PDMS (MED2-6215, NuSil Carpinteria, USA)  1330 . 
     From nusil.com/product/med-6215_optically-clear-low-consistency-silicone-elastomer: 
     MED-6215 is an optically clear, low consistency silicone elastomer. It is provided as two-parts which are solvent free and have a relatively low viscosity. It cures with heat via addition-cure chemistry. The mix ratio is 10:1 (Part A: Part B). 
     MED-6215 is considered substantially biocompatible—the manufacturer suggests that it may be used in human implantation for a period of greater than 29 days. 
     Uncured: 
       
     
       
         
           
               
               
               
               
             
               
                   
               
               
                 Typical 
                 Average 
                   
                 Nusil Test 
               
               
                 properties 
                 Result 
                 Standard 
                 (NT-TM) 
               
               
                   
               
             
            
               
                 Appearance 
                 Translucent 
                 ASTM D2090 
                 002 
               
               
                 Viscosity, Part A 
                 5,500 cP 
                 ASTM D1084, 
                 001 
               
               
                   
                 (5,500 mPas) 
                 D2196 
               
               
                 Viscosity, Part B 
                 95 cP (95 mPas) 
                 ASTM D1084 
                 001 
               
               
                   
                   
                 D2196 
               
               
                 Work Time 
                 5 hours 
                 — 
                 008 
               
               
                   
               
            
           
         
       
     
     Cured: 15 Minutes at 150° C. (302° F.) 
       
     
       
         
           
               
               
               
               
             
               
                   
               
               
                 Typical 
                 Average 
                   
                 Nusil Test 
               
               
                 properties 
                 Result 
                 Standard 
                 (NT-TM) 
               
               
                   
               
             
            
               
                 Specific Gravity 
                    1.03 
                 ASTM D792 
                 003 
               
               
                 Durometer, Type A 
                 50 
                 ASTM D2240 
                 006 
               
               
                 Tensile Strength 
                 1,250 psi 
                 ASTM D412 
                 007 
               
               
                   
                 (8.6 MPa) 
               
               
                 Elongation 
                 100% 
                 ASTM D412 
                 007 
               
               
                 Tissue Culture 
                 Pass 
                 USP ISO 
                 061 
               
               
                 (Cytotoxicity Testing) 
                   
                 10993-5 
               
               
                 Elemental Analysis 
                 Pass 
                 ASTM E305 
                 131 
               
               
                 of Trace Metals 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
               
               
             
               
                   
                   
               
               
                   
                 Property 
                 Average Result 
               
               
                   
                   
               
             
            
               
                   
                 Durometer 
                 50 Type A 
               
            
           
           
               
               
               
               
            
               
                   
                 Viscosity 
                 3,800 MPa*s 
                 (3800 cP) 
               
               
                   
                 Work Time 
                 5 
                 hours 
               
               
                   
                 Tensile 
                 8.62 MPa 
                 (1250 psi) 
               
            
           
           
               
               
               
            
               
                   
                 Appearance 
                 Transparent 
               
               
                   
                 Cure 
                 15 minutes/150° C. 
               
               
                   
                 Cure System 
                 Platinum 
               
               
                   
                 Elongation 
                 100% 
               
               
                   
                 Mix Ratio 
                 10:1  
               
               
                   
                 Specific Gravity 
                  1.03 
               
            
           
           
               
               
               
               
            
               
                   
                 Tack Free Time 
                 16 
                 hours 
               
            
           
           
               
               
               
            
               
                   
                 Comment 
                 Clear, 1.41 R.I. 
               
               
                   
                   
               
            
           
         
       
     
     The manufacturer suggests silicone primer Nu-Sil MED1-161 as a primer to further improve adhesion of MED-6215 to various substrates including: metals (such as stainless steel, steel, copper and aluminum), ceramic materials, rigid plastics, and other silicone materials. 
     MED-6215 is available in medical grade—in other words, substantially biocompatible and suitable for use in a medical implantable device. This is realized by ensuring all raw materials, intermediates, and finished products (for Medical Grade) are manufactured with applicable GMP and/or appropriate regulatory standards: cGMP 21 CFR § 820 (Device), cGMP 21 CFR § 210-211(Drug/API) and ISO 9001. 
     A dip-coating process was used for the encapsulation. The average relatively low viscosity, for example, 4000 to 7000 cP (mPas), appears to have allowed the PDMS to more easily flow over the sample. The thickness of the PDMS  1330  was estimated to be between 50 and 200 μm (micron). 
     B. Experimental Set-Up 
     The lifetime reliability of ALD coatings may depend on factors such as the conformality and adhesion of the layer, and its stability in ionic media. This was measured using the IDC&#39;s impedance after an extended soak test. 
     Extended soaking used phosphate buffered saline (PBS) at approximately room temperature (approx. 23° C.). 
     Electrochemical impedance spectrometry (EIS) was carried out to evaluate the performance of the ALD and ALD-PDMS coatings using the methods described in “Apparatus to investigate the insulation impedance and accelerated life-testing of neural interfaces”, Donaldson, Lamont, Shah Idil, Mentink, Perkins, J. Neural Eng, 2018, 10.1088/1741-2552/aadeac. 
     Measurements used a Solartron Modulab with a potentiostat in combination with a frequency response analyzer. Measurements were performed in a two-cell electrode configuration between the combs of the IDC structure. A Faraday cage was also used. 
     III. RESULTS AND DISCUSSION 
     A. Measurement Results 
     After sample preparation and submersion in saline, EIS measurements were performed. 
       FIGS. 8A and 8B  show the EIS results  1700 ,  1710  for three samples. 
       FIG. 8A  depicts Bode plots  1700 , with impedance magnitude along the vertical (Y) axis from 10 1  to 10 11  |Z| Ohm, and frequency along the horizontal (X) axis from 10 −2  to 10 5  Hz: 
     a bare IDC with exposed Pt metal  1701 , forming an approximately straight line from approx. 10 −2 , 5×10 6  to 10 4 , 10 2 , followed by a further straight line to 10 5 , 10 2 ;
         an IDC coated with HfO2 ALD  1702 , forming an approximately straight line from 10 −2 , 10 9  to 10 5 , 10 3  and   an IDC coated with an ALD-PDMS bilayer  1703 , forming an approximately straight line from 10 −2 , 10 11  to 10 5 , 10 5 .       

       FIG. 8B  depicts Bode plots  1710 , with phase along the vertical (Y) axis from 0 to −90 degrees, and frequency along the horizontal (X) axis from 10 −2  to 10 5  Hz:
         a bare IDC with exposed Pt metal  1711 , forming a curve passing through 10 −2 , −20 to 10°, −70 to 10 2 , −80 to 10 −4 , −20 to 10 −5 , 0;   an IDC coated with HfO2 ALD  1712 , forming a curve passing through 10 −2 , −60 to 10°, −80 to 10 2 , −90 to 10 −4 , −80 to 10 −5 , −70; and   an IDC coated with an ALD-PDMS bilayer  1713 , forming a curve passing through 10 −2 , −80 to 10°, −90 to 10 2 , −90 to 10 −4 , −80 to 10 −5 , −90.       

     For the bare IDC  1701 ,  1711 , in the middle frequency band (10 0  Hz-10 3  Hz), the phase  1711  appears to be relatively constant at approximately −80 degr. At lower frequencies (approx. 10 −2  Hz), the polarization resistance appears to be dominant, resulting in a phase of approximately −20 degr. It is believed that this indicates the metal fully exposed to an electrolyte. 
     The ALD-coated IDC  1702 ,  1712 , appeared to show relatively higher impedance values—this suggests a more capacitive behavior across the frequency range. This capacitance is believed to be caused by the Pt metal and electrolyte being separated by an ALD layer, which acts as a dielectric. It is believed that a fully conformal coating on the metal, or high resistance to fluid ingress, would result in a substantially capacitive behavior in the EIS results  1700 ,  1710 . 
     For the ALD-PDMS bilayer  1703 ,  1713 , the impedance  1703  and phase  1713  results show a substantially capacitive behavior across substantially the whole frequency range, with phase results  1713  close to approximately −90°. 
     It is believed that any delamination or cracking of the ALD layer may expose more metal to the electrolyte, possibly resulting in a substantially lower impedance and phase angle that is more significantly seen in the lower frequency regions &lt;10 −1  Hz. In  FIGS. 8A and 8B , a comparison between the ALD  1702 ,  1712  and ALD-PDMS bilayer  1703 ,  1713  shows an approximately two orders of magnitude higher impedance value  1703  for the bilayer encapsulated IDC  1703 ,  1713 . Furthermore, the phase results  1713  show a substantially more capacitive behavior. 
     Additionally, metal areas exposed due to ALD defects are also encapsulated with the PDMS, with a specific resistance of approximately 10 15  Ohm·cm. It is believed that any significant delamination of the PDMS from ALD would allow water condensation, resulting in one or more conductive paths between the combs. This may result in a lower impedance and phase angle more significantly seen in the lower frequency regions of approximately &lt;10 −1  Hz. 
     To track changes in the encapsulation and adhesion performance, monthly EIS measurements were done on all samples. The impedance and phase angle at approximately 10 −2  Hz were selected as the reference value to monitor over time. 
       FIGS. 8C and 8D  show the adhesion evaluation results  1720 ,  1730  for two ALD samples and two ALD-PDMS samples over the four hundred and fifty days of soaking. The results depicted in  FIGS. 8A and 8B  were considered as the values measured at T=0 days. 
       FIG. 8C  depicts adhesion evaluation  1720 , with impedance magnitude along the vertical (Y) axis from 0 to 10 11  |Z| Ohm, and Time along the horizontal (X) axis from 0 to 16 months:
         two IDC&#39;s coated with HfO2 ALD  1722   a ,  1722   b , forming an approximately straight line from 0, 10 9  to 16, 10 9 . Both samples provided substantially the same results, resulting in lines that are substantially overlapping, except for minimal deviations at 0 to 1 months, and 15 to 16 months; and   two IDC&#39;s coated with an ALD-PDMS bilayer  1723   a ,  1723   b , forming an approximately straight line from 0, 10 11  to 16, 10 11 . Both samples provided substantially the same results, resulting in lines that are substantially overlapping.       

       FIG. 8D  depicts adhesive evaluation  1730 , with phase along the vertical (Y) axis from −30 to −90 degrees, and Time along the horizontal (X) axis from 0 to 16 months:
         a first IDC  1732   a  coated with HfO2 ALD, forming an approximately straight line from 0, −70 to 16, −65;   a second IDC  1732   b  coated with HfO2 ALD, forming an approximately straight line from 0, −75 to 2, −63 to 4, −65 to 16, 60;   a first IDC  1733   a  coated with an ALD-PDMS bilayer, forming an approximately straight line from 0, −83 to 2, −78 to 6, −80 to 16, −80; and   a second IDC  1733   b  coated with an ALD-PDMS bilayer, forming an approximately straight line from 0, −80 to 2, −78 to 6, −77 to 10, −80 to 16, −78.       

     For the ALD-only samples  1722 ,  1732 , a drop in the phase angle  1732   a ,  1732   b  was measured after the first month of soaking, suggesting that fluid came into contact with the metals through one or more defects in the ALD layer. Substantially stable results were observed during the extended soaking. This is believed to indicate a substantially high stability of the HfO2 adhesion layer in ionic media and a substantially high degree of adhesion of HfO2 to Pt over an extended period of time. Significant deterioration of the HfO2 layer would be expected to show a relatively higher capacitive behavior, such as a significant drop in the impedance magnitude  1720 —this was not observed. Additionally, any significant delamination of the ALD layer from Pt would be expected to result in a substantially more resistive behavior, originating from the metal being exposed to saline—this was also not observed. 
     Optical inspections of the ALD samples  1722 ,  1732  supported these conclusions as no significant layer discoloration or degradation were observed. 
     For the ALD-PDMS bilayer samples  1723 ,  1733 , substantially stable results were thus recorded over an extended period, suggesting a relatively high degree of adhesion between the two layers, and a substantially higher resistance to the ingress of fluids. 
     B. Conclusions 
     Pt is widely used as for conductors and/or electrode regions due to its high degree of biocompatibility and stability. However, long term stability may be reduced in conventional systems due to the relatively weak adhesion of encapsulants, such as PDMS, parylene and epoxy to Pt. 
     From the results, it is believed that adding an adhesion layer comprising one or more ceramic materials may be advantageous. In particular, an HfO2 ALD layer with an average thickness of approximately 25 nm to 100 nm, preferably approximately 50 nm, may provide a substantially stable intermediate adhesion layer between Pt and the PDMS. Additionally, a relatively high degree of adherence was also measured between the HfO2 layer and the SiO2 substrate—in particular between the Pt forks. 
     Where appropriate, a substrate comprising other materials may thus be provided with a layer of SiO2 and/or Pt to improve adhesion to the HfO2 ALD layer. 
     The ALD-PDMS bilayer of an encapsulation layer  1330  and adhesion layer  1530  appears particularly advantageous:
         the HfO2 ALD adhesion layer appeared to show a significantly higher stability in ionic media, thereby, providing relatively longer resistance against delamination or water permeation through the PDMS encapsulation.   a PDMS having a relatively low average viscosity, for example 4000 to 7000 cP (mPas), for a significant time period during encapsulation, may further contribute to longer-lasting adhesion and defect reduction due to flowing of PDMS in-between any defects and openings in the ALD layer   PDMS-type materials are, in general, highly suitable for implantation due to their relatively high degree of biocompatibility. By appropriate selection and processing, many PDMS-type materials may be configured and arranged to be substantially biocompatible.       

     Polymeric materials comprised in the substrate  1400  are preferably selected for suitability to be flexible, and to comprise the one or more electrical conductors  1210 . Preferably, the polymeric substrate materials have a high degree of biocompatibility and durability. Suitable polymer materials for being comprised in substrate  1400  include those mentioned above for conformable substrates in relation to  FIG. 1  to  FIG. 4 . In particular, a polyimide, Parylene C, SU-8, an LCP, a polyurethane, or any combination thereof may be used. 
     Preferably, the first and/or second surface  1410 ,  1420  comprise a significant amount of one or more Liquid Crystal Polymers (LCP&#39;s). Optionally, the first and/or second surface  1410 ,  1420  may substantially consist of one or more LCP&#39;s. Optionally, the first and/or second surface  1410 ,  1420  may essentially consist of one or more LCP&#39;s. 
     The table below compares several physical and chemical properties of a typical polyimide and a typical LCP. 
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                   
                   
                 Polyimide 
               
               
                   
                 Unit 
                 LCP Flex 
                 Flex 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Thickness 
                 Um (micron) 
                 25, 50, 100 
                 12, 25, 50 
               
               
                 Dielectric constant 
                 — 
                 2.9 
                 3.2 
               
               
                 (10 GHz) 
               
               
                 Dissipation factor 
                 — 
                 0.002 
                 0.002 
               
               
                 (10 GHz) 
               
               
                 Surface resistivity 
                 ohm 
                 1.0E16 
                 4.0E13 
               
               
                 Volume resistivity 
                 Ohm cm 
                 1.0E18 
                 2.6E14 
               
               
                 Dielectric strength 
                 kV/mil 
                 3.5 
                 7 
               
               
                 Young&#39;s modulus 
                 GPa 
                 2.3 
                 7.1 
               
               
                 Tensile strength 
                 MPa 
                 280 
                 220 
               
               
                 CTE, x-y 
                 ppm/K 
                 18 
                 20 
               
               
                 CTE, z 
                 ppm/K 
                 200 
                 120 
               
               
                 Solder float 
                 ° C. 
                 &gt;288 
                 &gt;300 
               
               
                 temperature 
               
               
                 Melting temperature/glass 
                 ° C. 
                 330 
                 343 
               
               
                 transition 
               
               
                 Moisture absorption 
                 % 
                 0.04 
                 1 
               
               
                 (23° C., 24 h) 
               
               
                 Flammability 
                 — 
                 UL 94 VTM-0 
                 UL 94 V0 
               
               
                   
               
            
           
         
       
     
     Advantageously, the substrate  1400 , for example comprising an LCP, has a Young&#39;s modulus in the range 2500 to 3600 MPa (2.5 to 3.6 GPa). 
     Optionally, the substrate  1400  may further comprise one or more electrical or electronic components configured to receive energy when electrical energy is applied to the one or more electrical conductors  1210 . For example, they may be inductively-coupled, capacitively-coupled or directly connected. This is particularly advantageous with substrates comprising significant amounts of one or more LCP&#39;s as PCB-techniques may be used. Preferably, a bio-compatible metal such as gold or platinum is used. 
     Preferably, one or more encapsulation layers  1310 ,  1320  and one or more adhesion layers  1510 ,  1520  are configured and arranged to resist the ingress of fluids to at least a portion of one or more surfaces  1410 ,  1420  proximate the one or more components. 
     For example, the one or more components may be an active component, a passive component, an electronic component, an integrated circuit (IC), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), an analog component, a digital component, a surface-mount device (SMD), a through-hole package, a chip carrier, a pin grid array, a fat package, a small outline package, a chip scale package, a ball grid array, a small-pin-count package, a flexible silicon device, a thin-film transistor (TFT), and any combination thereof. 
     The one or more electrical components may be configured and arranged to: resist, store charge, induct, sense, stimulate, amplify, process data, detect, measure, compare, switch, time, store data, count, oscillate, perform logic, add, generate stimulation pulses, and any combination thereof. 
     The substrates  1400  may be further configured and arranged to have a degree of conformance as described above. They may be foil-like (or film-like) and follow the contours of underlying anatomical features very closely by being flexible. Very thin foil-like substrates  1400  have the additional advantage that they have increased flexibility. 
     An implantable electrical device  1100 ,  1101  as described herein may be comprised in an implantable medical device  1110 ,  1111 . For example, such a medical device  110 ,  1111  may be configured and arranged to provide a degree of sensing, stimulation, data processing, detection or measurement, data storage, oscillation, logic performance, stimulation pulses generation, or any combination thereof. 
     The embodiments described above in relation to  FIG. 1  to  FIG. 4 , and in particular the implantable stimulators  101 ,  102 ,  103 ,  104 ,  105  may comprise an implantable electrical device  1100 ,  1101 ,  1102 . 
     As depicted in  FIG. 12A , an improved implantable medical device  1110  may be provided by modifying the implantable device  1100 , depicted in  FIG. 11A . It is the same as the implantable electrical device  1100  depicted in  FIG. 11A , except in this cross-section:
         the substrate  1400  comprises three protected surfaces, each surface being protected by a further adhesion layer  1500  and a further encapsulation layer  1300 . The three protected surfaces comprise two opposite protected surfaces and a further adjacent surface;   the extent of the further adhesion layer  1500  is less than the extent of the substrate  1400  for the two opposite protected surfaces. The extent of the further adhesion layer  1500  is greater than the extent of the substrate  1400  for the third adjacent protected surface;   the extent of the further encapsulation layer  1300  is less than the extent of the substrate  1400  for the two opposite protected surfaces. The extent of the further encapsulation layer  1300  is greater than the extent of the substrate  1400  for the third adjacent protected surface; and   the extent of the further adhesion layer  1500  is less than the extent of the further encapsulation layer  1300  for each protected surface.       

     Functionally, it may also be considered that the further encapsulation layer  1300  comprises the first  1310  and second  1320  encapsulation layers depicted in  FIG. 11B . 
     Functionally, it may also be considered that the further adhesion layer  1500  comprises the first  1510  and second  1520  adhesion layers depicted in  FIG. 11B . 
     However, the substrate  1400  depicted in  FIG. 12A , comprises a further protected surface, adjacent to such a protected first or second surface. 
     The further encapsulation layer  1300  of  FIG. 12A  may be substantially identical, similar to a high degree or substantially different to the first encapsulation layer  1310  depicted in  FIG. 11A or 11B . The further encapsulation layer  1300  of  FIG. 12A  may be substantially identical, similar to a high degree or substantially different to the second encapsulation layer  1320  depicted in  FIG. 11B . 
     The further adhesion layer  1500  of  FIG. 12A  may be substantially identical, similar to a high degree or substantially different to the first adhesion layer  1510  depicted in  FIG. 11A or 11B . The further adhesion layer  1500  of  FIG. 12A  may be substantially identical, similar to a high degree or substantially different to the second adhesion layer  1520  depicted in  FIG. 11B . 
     The medical device  1110  further comprises:
         one or more stimulation electrodes  1220 , configured and arranged to transmit energy to human or animal tissue when electrical energy is applied to the one or more electrical conductors  1210 . For example, they may be inductively-coupled, capacitively-coupled or directly connected. In the example depicted, the one or more stimulation electrodes  1220  are directly connected to the one or more electrical conductors  1210 . In many neurostimulation applications, a plurality of electrodes  1220  may be required. These may be identical, similar or different to the electrodes  200 ,  400  described above in relation to  FIG. 1  to  FIG. 4 .       

     Optionally or additionally, one or more sensors  1230  may similarly be provided—such sensors  1230  are configured to be provided electrical signals and/or data to the one or more electrical conductors  1210 . For example, they may be inductively-coupled, capacitively-coupled or directly connected. If a multilayer substrate with electrical interconnections is provided, a high degree of customization is possible. For example, allowing direct measurements of parameters relevant for operation, such as humidity, temperature, electrical resistance and electrical activity. 
     Typically with neural-stimulation electrodes, one or more electrodes  1220  are configured and arranged to operate as a ground or return electrode—this may be one of the existing electrodes or one or more further electrodes as described above for the first  200   a ,  200   b  and second  400   a ,  400   b  electrodes described above in relation to  FIG. 1  to  FIG. 4 . 
     The skilled person will realize that such a stimulation electrode  1220  and/or a tissue sensor is preferably not completely covered by an encapsulation layer  1300  and/or an adhesion layer  1500  as a sufficiently high degree of electrical connection or exposure to the implant environment are required for their function. For example, at least part of a stimulation electrode  1220  and/or tissue sensor is masked during the encapsulation process to provide a conductive surface towards tissue. Additionally or alternatively, portions of the device may not be encapsulated. 
       FIG. 12A  depicts a device  1110  where substantially all of a stimulation electrode  1220  is substantially not covered. In addition, in this cross-section, a portion of the substrate  1400  is substantially not covered, providing a device  1110  with a substantially encapsulated portion and a substantially unencapsulated portion with one or more electrodes  1220 . The extent of the further adhesion layer  1500  in this cross-section for the two opposite surfaces is less than the extent of the further encapsulation layer  1300  for these surfaces—this may be advantageous as the edges of the further adhesion layer  1500  are at least partially encapsulated  1300 . 
     Applying this encapsulation to the implantable stimulators described above in relation to  FIG. 1  and  FIG. 4  generally provides a substantially unencapsulated portion with one or more electrodes  200 ,  400 , and a substantially encapsulated portion comprising a pulse generator  500 . 
       FIG. 12B  depicts a further embodiment of a medical device  1111 . More particularly, it depicts a cross-section through a portion of the substrate  1400  comprising one or more electrode  1220 . The further medical device  1111  is the same as the device  1110  depicted in  FIG. 12A  except, in general, in this cross-section:
         the substrate  1400  comprises four protected surfaces, each surface being protected by a further adhesion layer  1500  and a further encapsulation layer  1300 ;   the extent of the further adhesion layer  1500  is larger than the extent of substrate  1400  for each protected surface;   the extent of the further encapsulation layer  1300  is larger than the extent of the substrate  1400  for each protected surface; and   the extent of the further adhesion layer  1500  is less than the extent of the encapsulation layer  1300  for each protected surface.       

     In this cross-section, “a part” of the one or more stimulation electrodes  1220  is not completely covered to allow electrical connection or exposure to the implant environment after implantation. So, in the regions close to the stimulation electrodes  1220 , the general statements made above do not all apply completely. In particular, in this cross-section:
         the further adhesion layer  1500  has been applied to the surface of the substrate  1400  adjacent to the stimulation electrodes  1220  and also applied to edge portions of the surface of the electrodes  1220 . This may provide additional protection against ingress at any interface between the electrode  1220  and the substrate  1400 ; and   the further encapsulation layer  1300  has been applied to the surface of the substrate  1400  adjacent to the stimulation electrodes  1220 . However, is not significantly applied to edge portions of the surface of the electrodes  1220 .       

     In other words, in this cross-section at the edge portions of the surface of the electrodes  1220 , the extent of the further adhesion layer  1500  is approximately the same as the extent of the further encapsulation layer  1300 . 
     This may be advantageous in certain configurations as the surface area of further encapsulation layer  1300  in direct contact with the surface of the electrodes  1220  is greatly reduced. In some cases, this surface area may be substantially zero. 
     Applying this encapsulation to the implantable stimulators described above in relation to  FIG. 1  and  FIG. 4  generally provides a substantially encapsulated portion in which “a part” of the one or more electrodes  200 ,  400 , and a substantially encapsulated portion comprising a pulse generator  500 . 
     Optionally, it may be advantageous if the extent of the further encapsulation layer  1300  in this cross-section at an edge portion of one or more electrodes  1220  is greater than the extent of the further adhesion layer  1500 —in some configurations, this may be advantageous as the edges of the further adhesion layer  1500  are at least partially encapsulated  1300 . 
     So, the one or more stimulation electrodes  1220  and/or sensor are preferably comprised in a surface, configured and arranged to provide a tissue interface. 
     As described above, “comprised in a surface” means that the electrodes  1220  are relatively thin (for example, when the substrate conforms to a substantially planar surface, having an extent along a transverse axis. approximately perpendicular to a longitudinal axis of the substrate, of 20 to 50 microns or less Thinner electrodes may be also be used to further increase the degree of conformability, for example 1 micron or less), and attached to (or at least partially embedded in) the surface. 
     This is particularly advantageous with substrates comprising significant amounts of one or more LCP&#39;s as PCB/metallization-techniques may be used to provide conductive regions, which may be configured and arranged to be electrodes  1220  and/or sensors  1230 . As described above, a conductive material is preferably used such as gold, platinum, platinum black, TiN, IrO 2 , iridium, and/or platinum/iridium alloys and/or oxides. Conductive polymers, such as Pedot, may also be used. Preferably, bio-compatible conductive materials are used. 
     As described above, thicker metal layers are generally preferred over thinner metal layers for electrodes  1220  because they can be subjected to bodily substances that may dissolve the metal. However, thicker metal layers typically increase rigidity (reduce conformability) proximate the thicker layer. 
     In a second set of experiments, adhesion of PDMS MED2-4213 from NuSil to an LCP substrate was investigated using two different substrates and two different PDMS casting processes. 
     Different methods were used to evaluate the adhesion: adhesion evaluation by Peel-test dry, after PBS soaking at 60 degr. C, and a Peel-test based on ASTM D1876. 
     From nusil.com/product/med2-4213_fast-cure-silicone-adhesive: 
     MED2-4213 is a two-part, translucent, thixotropic, a relatively high extrusion rate, a relatively high tear strength, a relatively fast-cure silicone adhesive. It is also substantially free of tin (Sn), reducing the requirement for atmospheric moisture to cure. It also does not comprise significant amounts of curing byproducts, such as acetic acid or methyl alcohol. 
     MED2-4213 is considered substantially biocompatible—the manufacturer suggests that it may be used in human implantation for a period of greater than 29 days. Typical chemical and physical properties include: 
     Uncured: 
       
     
       
         
           
               
               
               
               
             
               
                   
               
               
                 Typical 
                   
                   
                 Nusil Test 
               
               
                 properties 
                 Result 
                 Standard 
                 Method 
               
               
                   
               
             
            
               
                 Appearance 
                 Translucent 
                 ASTM D2090 
                 002 
               
               
                 Viscosity, Part A 
                 80000 cP 
                 ASTM D1084, 
                 001 
               
               
                   
                 (80000 mPas) 
                 D2196 
               
               
                 Work Time 
                 15 hours minimum 
                 — 
                 008 
               
               
                   
               
            
           
         
       
     
     Cured: 15 Minutes at 150° C. 
       
     
       
         
           
               
               
               
               
             
               
                   
               
               
                 Typical 
                   
                   
                 Nusil Test 
               
               
                 properties 
                 Result 
                 Standard 
                 Method 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Specific Gravity 
                 1.12 
                 ASTM D792 
                 003 
               
               
                 Durometer, Type A 
                 15 
                 ASTM D2240 
                 006 
               
               
                 Tensile Strength 
                 1,000 psi 
                 ASTM D412 
                 007 
               
               
                   
                 (6.9 MPa) 
               
               
                 Elongation 
                 800% 
                 ASTM D412 
                 007 
               
               
                 Tear Strength 
                 130 ppi 
                 ASTM D624 
                 009 
               
               
                   
                 (23.0 kN/m) 
               
               
                   
               
            
           
         
       
     
     
       
         
           
               
               
               
             
               
                   
                   
               
               
                   
                 Property 
                 Average Result 
               
               
                   
                   
               
             
            
               
                   
                 Durometer 
                 15 Type A 
               
            
           
           
               
               
               
               
            
               
                   
                 Viscosity 
                 80,000 MPa*s 
                 (80000 cP) 
               
               
                   
                 Work Time 
                 15 
                 hours 
               
               
                   
                 Tensile 
                 6.9 MPa 
                 (1000 psi) 
               
            
           
           
               
               
               
            
               
                   
                 Appearance 
                 Translucent 
               
               
                   
                 Cure 
                 15 minutes/150° C. 
               
               
                   
                 Cure System 
                 Platinum 
               
               
                   
                 Elongation 
                 800% 
               
               
                   
                 Mix Ratio 
                 1:1 
               
               
                   
                 Specific Gravity 
                  1.12 
               
               
                   
                 Rheology 
                 Thixotropic/non-slump 
               
               
                   
                 Tear 
                 22.93 kN/m (130 ppi) 
               
               
                   
                   
               
            
           
         
       
     
     It may be advantageous if the first ( 1310 ) and/or second ( 1320 ) encapsulation layers have/has a tensile strength in the range 6 to 8 MPa. 
     NuSil suggests that in many bonding applications (for a substrate comprising Aluminum, Glass, PMMA, Silicone) the use of a silicone primer to improve suitable adhesion is not required. 
     Use of a primer is suggested by the manufacturer when adhering to substrates comprising Polyetherimide, PEEK, Plastic, Polycarbonate, Polyimide, Polysulphone, Polyurethane, and Stainless steel. 
     In order to study the adhesion properties of the PDMS on LCP with different processing methods and adhesion layers, two different test substrates were used:
         TYPE 1: an LCP 3-layered substrate with ALD coating on one side   TYPE 2: an LCP 2-layered laminated substrate with ALD coating on one side.       

     In general, it is advantageous to perform as few steps as possible when manufacturing an implantable electrical device—this may reduce the risk of introducing contamination or transport related issues, and it may reduce one or more costs. 
     A process with relatively few steps may be based around overmoulding electronics that are directly mounted on a substrate (here LCP). Depending on the hardware configuration, the PDMS used may need to adhere sufficiently well to surfaces such as:
         an ASIC passivation layer in case of wire-bonding   a Si-substrate in case of ASIC flip-chip or ACF mounting. Si-substrate is one of the relevant interfaces when using bare-die components. Bare die integrated circuits are often made from a wafer or substrate, that is a thin slice of crystalline silicon semiconductor. To make a bare-die component, this material undergoes many microfabrication processes to become an integrated circuit, but one side will always be the raw material that was used, most often crystalline silicon. Relevant interfaces include:   an ASIC interconnect   Gold from wire-bonds or stud bumps   an ACF (Anisotropic conductive film), which is frequently epoxy based, with coated gold particles, for application of a bare-die component on bond-pads.   the substrate—in this case, a substrate comprising significant amounts of LCP.       

     TYPE 1 LCP Substrates were Prepared Using One or More of the Following Process Steps: 
     a) Providing a substrate: these substrates were substantially planar sheets of LCP with an average thickness of approximately 0.150 mm. The substrate comprised three layers; two 0.050 mm layers of ULTRALAM® 3908, separated by one 0.050 mm layer of ULTRALAM 3850. 
     ULTRALAM® 3908 LCP is available from Rogers Corporation (www.rogerscorp.com) and may be used as a bonding medium (adhesive layer) between copper, other LCP materials and/or dielectric materials. It is characterized by low and stable dielectric constant. It has a relatively low modulus, allowing relatively easy bending for flex applications, and relatively low moisture absorption. 
     It may be used with one or more layers of ULTRALAM® 3850 LCP to create substantially adhesive-less substantially all-LCP multi-layer substrates. 
     Typical values for physical and chemical properties of ULTRALAM® 3908 LCP include: 
     Mechanical Properties 
       
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                 Typical 
                   
                 Test 
               
               
                   
                 value 
                 Units 
                 Methods 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Dimensional Stability 
                 MD: &lt;0.1 
                 % 
                 IPC 2.2.4 
               
               
                   
                 CMD: &lt;0.1 
                   
                 method A 
               
            
           
           
               
               
               
               
               
            
               
                 Initiation Tear 
                 1.4 
                 (3.1) 
                 Kg (lbs) 
                 IPC 2.4.16 
               
               
                 Strength, min 
               
               
                 Tensile Strength 
                 216 
                 (31) 
                 MPa (Kpsi) 
                 IPC 2.4.19 
               
               
                 Tensile Modulus 
                 2450 
                 (355) 
                 MPa (Kpsi) 
                 IPC 2.4.19 
               
            
           
           
               
               
               
               
            
               
                 Thickness Variation 
                 &lt;+/−10 
                 % 
                 ASTM-D374 
               
               
                   
               
            
           
         
       
     
     Thermal Properties 
       
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                 Typical 
                   
                 Test 
               
               
                   
                 value 
                 Units 
                 Methods 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Coefficient of Thermal 
                 X: 17 
                 ppm/° C. 
                 IPC 2.4.41.3 
               
               
                 Expansion, CTE 
                 Y: 17 
               
               
                 (30° C. to 150° C.) 
                 Z: 150 
               
               
                 Solder Float, Method B 
                 PASS 
                   
                 IPC 2.4.13 
               
               
                 (288° C.) 
               
               
                 Thermal Conductivity @ 50° C. 
                 0.20 
                 W/m/° K 
                 ASTM D5470 
               
               
                 Melting Temperature 
                 280 
                 ° C. 
                 DSC 
               
               
                 Relative Thermal Index 
               
               
                 (RTI) mechanical 
                 190 
                 ° C. 
               
               
                 electrical 
                 240 
                 ° C. 
               
               
                   
               
            
           
         
       
     
     Electrical Properties 
       
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                 Typical 
                   
                 Test 
               
               
                   
                 value 
                 Units 
                 Methods 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Dielectric Constant 
                 2.9 
                   
                 IPC 2.5.5.5.1 
               
               
                 (10 GHz, 23° C.) 
               
               
                 Dissipation Factor 
                 0.0025 
                   
                 IPC 2.5.5.5.1 
               
               
                 (10 GHz, 23° C.) 
               
               
                 Surface Resistivity 
                 1.2 × 10 12   
                 Mega Ohms 
                 IPC 2.5.17 
               
               
                 Volume Resistivity 
                 2.6 × 10 14   
                 Mega Ohms-cm 
                 IPC 2.5.17 
               
               
                 Dielectric Breakdown 
                 118 (3000) 
                 KV/cm (V/mil) 
                 ASTM-D-149 
               
               
                 Strength 
               
               
                   
               
            
           
         
       
     
     Environmental Properties 
       
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                 Typical 
                   
                 Test 
               
               
                   
                 value 
                 Units 
                 Methods 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Chemical Resistance 
                 98.7 
                 % 
                 IPC 2.3.4.2 
               
               
                 Water Absorption 
                 0.04 
                 % 
                 IPC 2.6.2 
               
               
                 (23° C., 24 hrs) 
               
               
                 Coefficient of 
                 4 
                 ppm/% RH 
                 60° C. 
               
               
                 Hydroscopic Expansion, 
               
               
                 CHE (60° C.) 
               
               
                 Flammability 
                 VTM-O 
                   
                 UL-94 
               
               
                   
               
            
           
         
       
     
     ULTRALAM® 3850 is available from Rogers Corporation (www.rogerscorp.com) and is a relatively high-temperature resistant LCP. It may be provided as a double copper clad laminate for use as laminate circuit materials. The manufacturer suggests these products for use as a single layer or a multilayer substrate. ULTRALAM 3850 circuit materials are characterized by a relatively low and stable dielectric constant, and dielectric loss. It has a relatively low modulus, allowing relatively easy bending for flex applications, and relatively low moisture absorption. 
     It may be used with one or more layers of ULTRALAM® 3908 LCP to create substantially adhesive-less substantially all-LCP multi-layer substrates. 
     Typical values for physical and chemical properties of ULTRALAM® 3850 LCP include: 
     Mechanical Properties 
       
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                 Typical 
                   
                 Test 
               
               
                   
                 value 
                 Units 
                 Methods 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
               
            
               
                 Dimensional 
                 MD: 
                 −0.06 
                 % 
                 IPC 2.2.4 
               
               
                 Stability 
                   
                   
                   
                 method B 
               
               
                   
                 CMD: 
                 −0.03 
               
               
                 Peel Strength 
                 0.95 
                 (8.52) 
                 N/mm (lbs/in) 
                 IPC 2.4.8 
               
               
                   
                   
                   
                   
                 (½ oz. 
               
               
                   
                   
                   
                   
                 ED foil) 
               
               
                 Initiation Tear 
                 1.4 
                 (3.1) 
                 Kg (lbs) 
                 IPC 2.4.16 
               
               
                 Strength, min 
               
               
                 Tensile Strength 
                 200 
                 (29) 
                 MPa (Kpsi) 
                 IPC 2.4.16 
               
               
                 Tensile Modulus 
                 2255 
                 (327) 
                 MPa (Kpsi) 
                 IPC 2.4.19 
               
            
           
           
               
               
               
               
            
               
                 Density 
                 1.4 
                 gm/cm3, Typical 
               
               
                   
               
            
           
         
       
     
     Thermal Properties 
       
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                 Typical 
                   
                 Test 
               
               
                   
                 value 
                 Units 
                 Methods 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Coefficient of Thermal 
                 X: 17 
                 ppm/° C. 
                 IPC 2.4.41.3 
               
               
                 Expansion, CTE 
                 Y: 17 
               
               
                 (30° C. to 150° C.) 
                 Z: 150 
               
               
                 Solder Float, Method B 
                 PASS 
                   
                 IPC 2.4.13 
               
               
                 (288° C.) 
               
               
                 Melting Temperature 
                 315 
                 ° C. 
                 DSC 
               
               
                   
                   
                 (Typical) 
               
               
                 Relative Thermal Index 
               
               
                 (RTI) mechanical 
                 190 
                 ° C. 
               
               
                 electrical 
                 240 
                 ° C. 
               
               
                 Thermal Conductivity 
                    0.2 
                 W/m/° K 
                 ASTM C518 
               
               
                 @ 50° C. 
               
               
                 Thermal Coefficient 
                 (+)24  
                 ppm/° C. 
                 IPC 2.5.5.5, 
               
               
                 of ∈r, −50° C. to 150° C. 
                   
                   
                 8 GHz 
               
               
                   
               
            
           
         
       
     
     Electrical Properties 
       
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                 Typical 
                   
                 Test 
               
               
                   
                 value 
                 Units 
                 Methods 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Dielectric Constant, 
                 2.9 
                   
                 IPC 2.5.5.5.1 
               
               
                 10 GHz, 23° C. 
               
               
                 (Process) 
               
               
                 Dielectric Constant, 
                 3.14 
                   
                 Differential 
               
               
                 10 GHz, 23° C. 
                   
                   
                 Phase 
               
               
                 (Design) 
                   
                   
                 Length Method 
               
               
                 Dissipation Factor 
                 0.0025 
                   
                 IPC 2.5.5.5.1 
               
               
                 (10 GHz, 23° C.) 
               
               
                 Surface Resistivity 
                 1 × 10 10   
                 Mega Ohms 
                 IPC 2.5.17 
               
               
                 Volume Resistivity 
                 1 × 10 12   
                 Mega Ohms-cm 
                 IPC 2.5.17 
               
               
                 Dielectric Breakdown 
                 1378 (3500) 
                 KV/cm (V/mil) 
                 ASTM-D-149 
               
               
                 Strength 
               
               
                   
               
            
           
         
       
     
     Environmental Properties 
       
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                 Typical 
                   
                 Test 
               
               
                   
                 value 
                 Units 
                 Methods 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                 Chemical Resistance 
                 98.7 
                 % 
                 IPC 2.3.4.2 
               
               
                 Water Absorption 
                 0.04 
                 % 
                 IPC 2.6.2 
               
               
                 (23° C., 24 hrs) 
               
               
                 Coefficient of 
                 4 
                 ppm/% RH 
                 60° C. 
               
               
                 Hydroscopic Expansion, 
               
               
                 CHE (60° C.) 
               
               
                 Flammability 
                 VTM-0 
                   
                 UL-94 
               
               
                   
               
            
           
         
       
     
     TYPE 1 LCP Substrates were Further Prepared Using One or More of the Following Process Steps: 
     b1) an optional pre-cleaning of at least a portion of the substrate using IPA, followed by drying. Another suitable alcohol may also be used. 
     b2) Applying an adhesion coating: using ALD, a coating was applied to an outer surface of the substrate—in this case a surface comprising ULTRALAM® 3908 LCP. Ten alternating layers of approximately 5 nm Al 2 O 3  and of approximately 5 nm HfO2, resulted in an approximately 100 nm multilayer. The extent of the ALD coating was approximately the same as the extent of the substrate. The ALD coating was applied using the PICOSUN® R-200 Advanced ALD reactor described above. It was applied at a temperature substantially lower than the melting temperature of the LCP. For these TYPE 1 LCP substrates, it was applied at approximately 125 degr C. after an optional stabilization time of approximately 90 minutes. 
     For comparison, this step was omitted for some of the samples (in other words, the PDMS was applied directly to the LCP). 
     c) Cleaning at least a portion of the adhesion coating: as preparation for the PDMS coating, an optional ten-minute ozone (O3) plasma treatment was performed to clean the ALD surface. The PDMS was applied within fifteen minutes from the ozone cleaning. For comparison, some samples were not cleaned before the PDMS coating was applied. 
     UV O3 (ozone) plasma cleaning is suitable for dry, non-destructive atomic cleaning and removal of organic contaminants. It uses intense 185 nm and 254 nm ultraviolet light. In the presence of oxygen, the 185 line produces Ozone and while the 254 line excites organic molecules on the surface. This combination drives the rapid destruction and decimation of organic contaminants. 
     d) Applying an encapsulation coating: a PDMS coating of approximately 500 um to 1000 um of MED2-4213 was applied on top of the ALD coating. A syringe was filled with MED2-4213, and mixed &amp; degassed at relatively high speed (2500 rpm) for three minutes. It was cured at 150 degr C. for 10 min and post-cured at 80 degr C. for 24 hours. The extent of the PDMS coating was less than the extent of the ALD coating, whereby the ALD coating was exposed (not covered by encapsulant) close to the edge of the substrate. After applying the PDMS on the substrate, the substrate was placed on the PTFE (polytetrafluorethylene)-coated pre-heated plate, and a weight was pressed on top of it. 
     So, six samples of TYPE 1 LCP were prepared: 
     
       
         
           
               
               
               
               
               
             
               
                   
                   
               
               
                   
                 Nr of 
                 ALD 
                   
                 PDMS 
               
               
                   
                 samples 
                 coating 
                 Cleaning 
                 coating 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
               
               
            
               
                   
                 1.1 
                 Two 
                 None 
                 None 
                 MED2- 
               
               
                   
                   
                   
                   
                   
                 4213 
               
               
                   
                 1.2 
                 Two 
                 Ten x 
                 None 
                 MED2- 
               
               
                   
                   
                   
                 (5 nm Al2O3 + 
                   
                 4213 
               
               
                   
                   
                   
                 5 nm HfO2) 
               
               
                   
                 1.3 
                 Two 
                 Ten x 
                 O3-plasma 
                 MED2- 
               
               
                   
                   
                   
                 (5 nm Al2O3 + 
                 (10 min) 
                 4213 
               
               
                   
                   
                   
                 5 nm HfO2) 
               
               
                   
                   
               
            
           
         
       
     
     A Pass/Fail test was defined for the TYPE 1 LCP substrates by hand:
         after curing the PDMS, a dry Peel-test was performed (no soaking) and the degree of delamination was noted   after the dry Peel-test, the samples were soaked in a PBS solution at 60 degr C. for 1 day, 1 week, and 4 weeks, and the Peel-test was repeated to determine a second degree of delamination.       

     Three degrees of delamination were defined:
         Delamination: the PDMS can be removed relatively easily from the substrate   Partial delamination: the PDMS can be removed relatively easily in some areas, but sticks relatively well in other areas   Adhesion: the PDMS does not substantially delaminate       

     Phosphate-buffered saline (abbreviated PBS) is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium chloride and, in some formulations, potassium chloride and potassium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions are selected to match those of the human body (isotonic). 
     
       
         
           
               
               
               
               
               
             
               
                   
               
               
                   
                   
                   
                 Soak after 
                 Soak after 
               
               
                   
                   
                 Soak after 
                 1 week 
                 4 weeks 
               
               
                 Sam- 
                   
                 24 h @60° C. 
                 @60° C. 
                 @60° C. 
               
               
                 ples 
                 Dry 
                 PBS 
                 PBS 
                 PBS 
               
               
                   
               
             
            
               
                 1.1 
                 Delamination 
                 Not applicable 
                 Not applicable 
                 Not applicable 
               
               
                 1.2 
                 Adhesion 
                 Partial 
                 Partial 
                 Partial 
               
               
                   
                   
                 Delamination 
                 Delamination 
                 Delamination 
               
               
                 1.3 
                 Adhesion 
                 Adhesion 
                 Adhesion 
                 Adhesion 
               
               
                   
               
            
           
         
       
     
     Samples 1.1: in general, PDMS has a low degree of adhesion to LCP 
     Samples 1.2: the PDMS could not be peeled from the surface in dry state. After twenty-four hours of soaking, part of the PDMS could be peeled from the substrate, although no moisture filled voids were observed. After peeling away some of the PDMS, the rest stuck so well to the substrate it could not be peeled off any further, not even after 1 or 2 weeks of additional soaking. It was suspected that the initial delamination was due to local contamination during PDMS processing or processing issues. 
     Samples 1.3: these samples showed good adhesion. No delamination was achieved in dry and wet conditions until after two weeks of testing. 
     Conclusions:
         In general, PDMS had a low degree of adhesion to LCP without any adhesion layer (samples 1.1).   In samples 1.2 (coated with ALD and then encapsulated with PDMS without O3 cleaning), the PDMS could not be peeled from the surface in dry state. After 24 hours of soaking, part of the PDMS could be peeled from the substrate, although no moisture filled voids were observed. After peeling away some of the PDMS, the rest stuck so well to the substrate it could not be peeled off any further, not even after two weeks of additional soaking. Samples with a more conformal ALD multilayer showed good adhesion even after two weeks of soaking.   Samples 1.3 (coated with ALD and encapsulated with PDMS after an O3 cleaning step) showed the highest degree of adhesion. No substantial delamination was achieved in dry or wet conditions (after 2 weeks of soaking)   An Al2O3/HfO2 multilayer ALD layer with a total average thickness of approximately 50 nm to 200 nm, preferably approximately 100 nm, may provide an advantageous intermediate adhesion layer between LCP and the PDMS polymer.       

     TYPE 2 LCP Laminated Substrates were Prepared Using One or More of the Following Process Steps: 
     a) Providing a substrate: these substrates were laminated sheets of LCP, with an average thickness of approximately 0.110 mm. The substrate comprised four layers; one outer layer of copper connection pads, one 0.050 mm layer of ULTRALAM® 3850, one inner layer of one or more copper conductors, and one 0.025 mm layer of ULTRALAM 3908: 
     a1) an approximately 50 um-thick sheet of LCP ULTRALAM® 3850, clad on a first surface with a first copper layer. This first copper layer was approximately 18 um-thick. The first copper layer was configured and arranged to form copper connection pads, for example by masking and etching, which may be considered to be comprised in an outer surface of the laminated substrate; 
     a2) the ULTRALAM® 3850 was further clad with a further copper layer. This second layer was approximately 18 um-thick. Optionally, it may be configured and arranged to form one or more conductors, for example by masking and etching, which may be considered to be comprised in an inner surface of the laminated substrate. If no inner conductors are required, the further copper layer may be omitted or completely removed; 
     a3) an approximately 25 um-thick sheet of LCP ULTRALAM® 3908, bonded to the inner surface of the ULTRALAM® 3850 layer, and further bonded to the one or more conductors. 
     Optionally, the laminated sheets may be substantially planar. 
     b) Applying an adhesion coating: 
     b1) an optional pre-cleaning of at least a portion of the substrate using IPA, followed by drying. Another suitable alcohol may also be used. 
     b2) using ALD, a coating was applied to an outer surface of the substrate—in this case a surface comprising ULTRALAM® 3908 LCP. It was not the outer surface of the substrate comprising one or more connection pads. Ten alternating layers of approximately 5 nm Al 2 O 3  and of approximately 5 nm HfO2 resulted in an approximately 100 nm multilayer. The ALD coating was applied using the PICOSUN® R-200 Advanced ALD reactor described above. It was applied at a temperature substantially lower than the melting temperature of the LCP. For these TYPE 1 LCP substrates, it was applied at approximately 125 degr C. after an optional stabilization time of approximately 90 minutes. The extent of the ALD coating was approximately the same as the extent of the substrate. 
     b3) Applying an adhesion improver: MED-166 from NuSil is a specially formulated primer which is suggested by the manufacturer to improve adhesion of PDMS to various substrates including: rigid plastics, and other silicone materials. The manufacturer suggests that it is suitable for use in human implantation for a period of greater than 29 days. 
     c) Cleaning at least a portion of the adhesion coating before encapsulation: 
     c1) Option 1: cleaning using ethanol, followed by drying for 4 hours at 70° C. Another suitable alcohol may also be used. 
     c2) Option 2: exposing the ALD surface to a plasma comprising O2. 
     O2 (oxygen) plasma refers to any plasma treatment performed while actively introducing oxygen gas to the plasma chamber. Oxygen plasma is created by utilizing an oxygen source on a plasma system. 
     Additionally or alternatively, ozone (O3) may be used. 
     d) Applying an encapsulation coating: 
     d1) Applying an encapsulation mask to simplify testing: a strip of Kapton tape (10 mm wide) was applied to one edge to mask a small section to which the pull-tester is to be clamped during the Peel-test. 
     d2) Applying an encapsulation coating: a PDMS coating of approximately 500 um to 1000 um of MED2-4213 was applied on top of the ALD coating. Vacuum centrifugal casting at 100 degr. C used with PTFE-coated molds under a relatively low vacuum, for example 800-900 Pa (8 to 9 mbar)—vacuum centrifugal casting was used to reduce the risk of air inclusion in the PDMS. In general, applying a vacuum may be advantageous in improving the application to an adhesion coating of the encapsulation of a PDMS having an average viscosity in the range 55000 to 100000 cP (mPas) for a significant time period. 
     The extent of the PDMS coating was approximately the same as the extent of the ALD coating. After removing the Kapton tape, a strip of approximately 10 mm wide was provided where the PDMS was not attached to the ALD coating. 
     e) Performing further processing: the coated substrate of approximately 100×75 mm area was cut into 7 pieces of approximately 100×10 mm for Peel-testing. Each piece had an area of approximately 10×10 mm without the PDMS coating at is edge due to Kapton tape removal. 
     So, fifteen samples of type (2) were prepared: 
     
       
         
           
               
               
               
               
               
               
             
               
                   
                   
               
               
                   
                 Nr of 
                 ALD 
                   
                   
                 PDMS 
               
               
                   
                 samples 
                 coating 
                 Primer 
                 Cleaning 
                 coating 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
               
               
            
               
                 2.1 
                 Three 
                 None 
                   
                 Ethanol 
                 MED2- 
               
               
                   
                   
                   
                   
                   
                 4213 
               
               
                 2.2 
                 Three 
                 None 
                 MED-166 
                 Ethanol 
                 MED2- 
               
               
                   
                   
                   
                   
                   
                 4213 
               
               
                 2.3 
                 Three 
                 10x 
                 None 
                 Ethanol 
                 MED2- 
               
               
                   
                   
                 (5 nm Al2O3 + 
                   
                   
                 4213 
               
               
                   
                   
                 5 nm HfO2) 
               
               
                 2.4 
                 Three 
                 None 
                 None 
                 O2 plasma 
                 MED2- 
               
               
                   
                   
                   
                   
                 treatment 
                 4213 
               
               
                 2.5 
                 Three 
                 10x 
                 None 
                 O2 plasma 
                 MED2- 
               
               
                   
                   
                 (5 nm Al2O3 + 
                   
                 treatment 
                 4213 
               
               
                   
                   
                 5 nm HfO2) 
               
               
                   
               
            
           
         
       
     
     Peel-test according to ASTM D1876 was adapted for testing the TYPE 2 LCP or laminated substrates). A Peel-tester was used to measure the lamination force. 
     4. Peel-Test Results 
       FIG. 9  depicts a graph  1750  comparing the average pull force under dry (not soaked) conditions with the average pull forces after 24 hours of soaking at 60 degr. C in PBS. The samples of LCP were coated with PDMS using different processes. 
     Average peel force is plotted along the vertical (Y) axis from 0 to 18 N, and the results are indicated for the different samples along the horizontal (X) axis. To simplify interpretation, the order of the samples chosen is numerical: from left to right, samples 2.2, 2.2, 2.3, 2.4 and 2.5. 
     For each sample, the vertical length of each bar indicates the average peel force in Newtons (N). For each bar, an “I” shaped line is also depicted to indicate the variation measured in the pull force values used to determine the average. For each sample, an unfilled bar is depicted on the left-hand side showing the average pull force under dry conditions, and a hatched bar on the right-hand side showing the average pull force after 24 hours of soaking at 60 degr. C in PBS. 
     For sample 2.1, an unfilled bar  1761   a  is depicted of approx. 4N, with a relatively small degree of variation. No value after soaking is depicted. 
     For sample 2.2, an unfilled bar  1762   a  is depicted of approx. 13N, with an average degree of variation. A hatched bar  1762   b  is depicted of approx. 14N, with a relatively high degree of variation. 
     For sample 2.3, an unfilled bar  1763   a  is depicted of approx. 5N, with a relatively small degree of variation. A hatched bar  1763   b  is depicted of approx. 7N, with an average degree of variation. 
     For sample 2.4, an unfilled bar  1764   a  is depicted of approx. 7N, with a relatively small degree of variation. A hatched bar  1764   b  is depicted of approx. 7.5N, with an average degree of variation. 
     For sample 2.5, an unfilled bar  1765   a  is depicted of approx. 8N, with a relatively small degree of variation. A hatched bar  1765   b  is depicted of approx. 8N, with an average degree of variation. 
     The average peel forces measured were: 
     
       
         
           
               
               
               
               
             
               
                   
                   
               
               
                   
                   
                   
                 Average Peel Force 
               
               
                   
                   
                   
                 (N) - After 24 
               
               
                   
                   
                 Average Peel Force 
                 hours soaking in 
               
               
                   
                 Samples 
                 (N) - Dry 
                 PBS at 60 degr. C. 
               
               
                   
                   
               
             
            
               
                   
                 2.1 
                 4.05 (761a) 
                 Not applicable 
               
               
                   
                 2.2 
                 13.38 (762a)  
                 14.22 (762b)  
               
               
                   
                 2.3 
                 5.23 (763a) 
                 7.29 (763b) 
               
               
                   
                 2.4 
                 7.31 (764a) 
                 7.56 (764b) 
               
               
                   
                 2.5 
                 8.31 (765a) 
                 8.32 (765b) 
               
               
                   
                   
               
            
           
         
       
     
     It appears that a stable over molding encapsulation process was achieved, showing substantially none, or very few, air bubbles in the PDMS. Substantial delamination of the LCP/PDMS interface was observed on 3 out of 7 samples directly after over molding. For this reason, the Peel-test was applied to get a more qualitative measure of the adhesion strength. 
     Samples 2.1: without additional priming or cleaning, the PDMS had a very low degree (approx. 4N— 1761   a ) of adhesion to LCP. 
     Samples 2.2: substrates with a primer appeared to have a relatively high degree of adhesion (approx. 13N— 1762   a —compared to approx. 4N— 1761   a ). During the test, some regions had a higher degree of adhesion, which resulted in the PDMS rupturing before peeling the samples completely. The average pull force after the soaking test appeared to be higher at approx. 14N— 1762   b , but a relatively high degree of deviation was also observed. 
     Samples 2.3: by adding an ALD multilayer, specifically the HfO2-Al2O3 multilayer ending with HfO2, the degree of dry adhesion appeared improved (from approx. 4N— 1761   a —to approx. 5N— 1763   a ). The results under dry conditions— 1763   a —appears to have a very low degree of deviation. The average pull force after the soaking test appeared to be higher at approx. 7N— 1763   b.    
     Samples 2.4: O2-plasma activation also appeared to increase the adhesion (approx. 7N— 1764   a —compared to approx. 4N— 1761   a ). The average pull force after the soaking test appeared to be slightly higher at approx. 7.5N— 1764   b.    
     Samples 2.5: plasma activation appeared to further improve the degree of adhesion (approx. 8N— 1765   a —compared to approx. 4N— 1761   a ). The average pull force after the soaking test appeared to be approximately the same at 8N— 1765   b . A small increase in deviation— 1765   b —was observed after soaking. 
     Conclusions: 
     A relatively high degree of adhesion was observed using a primer—for example, MED-166 from NuSil may be used. But it may be less-preferred in some uses. In particular, for implantable devices, it is advantageous to use materials that are significantly biocompatible and more preferably materials that are substantially biocompatible (have a high degree of biocompatibility). Although the manufacturer of MED-166 suggests that it is suitable for implantation for more than 29 days, primers are often epoxy adhesives which use volatile solvents. This may increase the risk of contamination due to insufficient evaporation and/or require additional process steps to ensure sufficient solvent removal. 
     In addition, for implantable devices, a high degree of quality control is often required to limit the risk of defects. Primers must typically be applied using a spray coating process, which may be difficult to perform with a high degree of reliability. It is believed that such reliability issues were the cause of the partial delamination observed. 
     An Al2O3/HfO2 multilayer ALD layer with a total average thickness of approximately 50 nm to 200 nm, preferably approximately 100 nm, may provide an advantageous intermediate adhesion layer between LCP and the PDMS polymer. In general, a ceramic layer with a thickness of less than:
         the ALD coating used improved adhesion of PDMS to LCP using materials suitable for use in an implantable electrical device.   the ALD multilayer stack not only improved the adhesion, but also improved the barrier property to protect a surface region against moisture ingress. This is preferred over a primer because the primer typically has a high degree of permeability for moisture. Based upon the improved adhesion between a PDMS and surfaces comprising a significant amount of Pt, SiO2 and an LCP, an adhesion layer comprising a ceramic material may be advantageously used for a wide range of substrate materials. In particular, adhesion of a PDMS may be improved where a first surface  1410  and/or second surface  1420  comprises a significant amount of a substance selected from the group comprising: a Liquid-Crystal Polymer (LCP), a polyimide, Parylene-C, SU-8, a polyurethane, or any combination thereof. These substances may be comprised in a flexible substrate.       

     Where appropriate, a substrate comprising other materials may thus be provided with a layer of such a material to improve adhesion to the HfO2 ALD layer. 
     The skilled person will also realize that adhesion may be improved by optionally or additionally applying a conformal coating to such a substrate, for example with an ALD process, applying a layer of SiO2 (silicon dioxide). 
     PDMS is, in general, a silicone rubber, with siloxane as the basic repeating unit. Methyl groups are substituted by a variety of other groups, for example, phenyl, vinyl or trifluoropropyl groups, depending on the type of PDMS, enabling the linkage of organic groups to an inorganic backbone. 
     Based upon the improved adhesion to a PDMS using one or more adhesion layers comprising HfO2 and/or Al2O3, an adhesion layer comprising a suitable ceramic material may be advantageously used for a wide range of substrate materials. 
     Suitable ceramic surfaces are relatively rich in hydroxyl groups. It is believed that the high degree of adhesions is due to oxygen in suitable PDMS-types can form strong bonds with the hydroxyl groups on the suitable ceramic surface. This may be chemical bonding, hydrogen-bridge bonding or some combination. 
     Suitable ceramics include:
         carbides, such as silicon carbide (SiC);   oxides, such as aluminum oxide (Al2O3);   nitrides, such as with silicon (SixNy or SiNxOy) and, in particular, silicon nitride (Si3N4); and       

     many other materials, including the mixed oxide ceramics that can act as superconductors. 
     In particular, adhesion of a PDMS may be improved where the ceramic material is selected from the group comprising: HfO2, Al2O3, Ta2O3, TiO2, and any combination thereof. 
     It is also expected that Diamond-like carbon may be advantageously used to improve adhesion. 
     Adhesion may be further improved by activating the surface of the ceramic layer—for example, by applying an alcohol, in particular ethanol; using a plasma comprising O3 (Ozone) and/or comprising O2; treating with a silane; or any combination thereof. 
     An adhesion layer may be a bi-layer or multilayer, in which one or more layer may be configured and arranged for a relatively high degree of adhesion, and one or more layers may be configured and arranged for a relatively high degree of corrosion resistance (impermeability). 
     For example, it is believed that a layer comprising Al2O3 provides a relatively high degree of adhesion. For example, it is believed that a layer comprising HfO2 provides a relatively high degree of corrosion resistance. 
       FIG. 5  and  FIG. 6  also depict examples of nerves that may be stimulated using one or more suitably configured improved medical devices  1110 ,  1111 , configured to provide neurostimulation to treat, for example, headaches, chronic headaches or primary headaches. In particular, if the substrate is substantially flexible (or conformable), it may conform better to the curved surfaces of the head and/or skull. This means that the comfort to the user of an implantable medical device  1110 ,  1111  may be increased by applying one or more of the features described above for improving conformance. 
     In many cases, these will be the approximate locations  810 ,  820 ,  830 ,  840  for the one or more implantable medical devices  110 ,  111 . 
     For each implant location,  810 ,  820 ,  830   a/b ,  840   a/b  a separate stimulation device  110 ,  111  may be used. Where implant locations  810 ,  820 ,  830   a/b ,  840   a/b  are close together, or even overlapping a single stimulation device  110 ,  111  may be configured to stimulate at more than one implant location  810 ,  820 ,  830   a/b ,  840   a/b.    
     A plurality of implantable medical devices  110 ,  111  may be operated separately, simultaneously, sequentially or any combination thereof to provide the required treatment. 
       FIG. 7  depicts further examples of nerves that may be stimulated using one or more suitably configured improved implantable medical devices  110 ,  111  to provide neurostimulation to treat other conditions. 
     The descriptions thereof herein should not be understood to prescribe a fixed order of performing the method steps described therein. Rather the method steps may be performed in any order that is practicable. Similarly, the examples used to explain the algorithm are presented as non-limiting examples, and are not intended to represent the only implementations of these algorithms. The person skilled in the art will be able to conceive many different ways to achieve the same functionality as provided by the embodiments described herein. 
     For example, one or more features that improve conformance may be applied to embodiments that are configured and arranged for improved encapsulation. In some embodiments, it may be advantageous to apply features that improve encapsulation but reduce conformance. 
     For example, one or more features that improve encapsulation may be applied to embodiments that are configured and arranged for improved conformance. In some embodiments, it may be advantageous to apply features that improve conformance but reduce encapsulation. 
     Many types of implantable distal ends of stimulation devices are depicted. But this does not exclude that the rest of the device is implanted. This should be interpreted as meaning that at least the electrode section of the distal end is preferably configured and arranged to be implanted. 
     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 can be made to the disclosed embodiments without departing from the spirit and scope of the invention as set forth in the appended claims. 
     In a non-limiting example,
         one or more electrodes of the first type  200   a ,  200   b ,  1220  are comprised in the first surface  310 ,  1410  and one or more electrodes of the second type  400   a ,  400   b ,  1220  are comprised in the second surface  320 ,  1420 ; or   one or more electrodes of the first type  200   a ,  200   b ,  1220  are comprised in the first surface  310 ,  1410  and one or more electrodes of the second type  400   a ,  400   b ,  1220  are also comprised in the first surface  310 ,  1410 ; or   one or more electrodes of the first type  200   a ,  200   b ,  1220  are comprised in the second surface  320 ,  1420  and one or more electrodes of the second type  400   a ,  400   b ,  1220  are comprised in the first surface  310 ,  1410 ; or   one or more electrodes of the first type  200   a ,  200   b ,  1220  are comprised in the second surface  320 ,  1420  and one or more electrodes of the second type  400   a ,  400   b ,  1220  are also comprised in the second surface  320 ,  1420 ; or   any combination thereof.       

     By providing relatively larger higher electrode  200 ,  400 ,  1220  surfaces, stimulators  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1100 ,  1101 ,  1102  may be operated at a lower energy/lower power. This may be advantageous in applications where high frequency and/or burst stimulation is used. 
     High frequency operation may require more energy to be provided by the pulse generator  500 . In applications where energy/power is critical, such as, in a non-limiting example, if an increased operating lifetime is desired from a power source for the pulse generator  500 ), any reduction in required power may be advantageous. High frequency operation may be considered as generating electrical stimulation pulses with a frequency of 1000 Hz or more, preferably 1500 Hz or more, more preferably 2000 Hz or more, yet more preferably 2500 Hz or more. 
     In an embodiment, experiments with burst stimulation have been performed such as Burst Occipital Nerve Stimulation for Chronic Migraine and Chronic Cluster Headache by Garcia-Ortega et al, Neuromodulation 2019; 22: 638-644, DOI: 10.1111/ner.12977. 
     For burst operation, the pulse generator  500  is further configured and arranged to generate electrical stimulation pulses in groups of stimulation pulses. 
     In a non-limiting example, groups (or bursts) of stimulation pulses may comprise 2 to 10 pulses, more preferably 2 to 5 stimulation pulses. Stimulation pulses in a group may have a repetition frequency of more than 500 Hz, typically 1000 Hz or more. Groups may be repeated at more than 5 Hz, typically 40 Hz or more. 
     As with high frequency operations, burst operation may require more energy to be provided by the pulse generator  500 , and any reduction in required power may be advantageous. 
     Additionally, the speed of charge-balance recovery may also increase with a lower impedance. By using a relatively thin-foil substrate  300 ,  1400 , stimulation between an electrode of the first type  200 ,  1220  comprised in one surface  310 ,  1410 ,  320 ,  1420  and an electrode of the second type  400 ,  1220  comprised in the other surface  310 ,  1410 ,  320 ,  1420 , the current path in tissue is relatively short, reducing impedance. 
     Similarly, using a substrate  300 ,  1400  and stimulation between an electrode of the first type  200 ,  1220  comprised in one surface  310 ,  1410 ,  320 ,  1420  and an adjacent electrode of the second type  400 ,  1220  comprised in the same surface  310 ,  1410 ,  320 ,  1420  provide a relatively short path through tissue. 
     While certain illustrative embodiments have been described, it is evident that many alternatives, modifications, permutations and variations will become apparent to those skilled in the art in light of the foregoing description without departing from the spirit and scope of the invention as set forth in the following claims. 
     The invention encompasses every possible combination of the various features of each embodiment disclosed. One or more of the elements described herein with respect to various embodiments can be implemented in a more separated or integrated manner than explicitly described, or even removed or rendered as inoperable in certain cases, as is useful in accordance with a particular application. 
     Particularly advantageous combinations of features include the following non-limiting examples: 
     (i). An implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1110 ,  1111  comprising:
         a pulse generator  500  for generating one or more electrical treatment stimulation pulses;   a conformable foil-like substrate  300 ,  1400  having a longitudinal axis  600  extending from the pulse generator  500  to a distal end of the substrate  300 ,  1400  the substrate  300 ,  1400  comprising one or more adjacent polymeric substrate layers, the substrate having a first  310 ,  1410  and second  320 ,  1420  planar surface;   an electrode array  200 ,  400 ,  1220  proximate the distal end, having a first  200   a ,  200   b ,  1220  and second  400   a ,  400   b ,  1220  electrode comprised in the first  310 ,  1410  or second  320 ,  1420  surface, each electrode  200 ,  400 ,  1220  in operation being configurable for transferring treatment energy, in use, to and/or from human or animal tissue;       

     the implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1110 ,  1111  further comprising:
         one or more electrical interconnections  250 ,  1210  between the pulse generator  500  and the first  200   a ,  200   b ,  1220  and the second  400   a ,  400   b ,  1220  electrodes, for transferring electrical energy as one or more electrical treatment stimulation pulses to the first electrode  200   a ,  200   b ,  1220  and/or the second electrodes  400   a ,  400   b ,  1220 ;       

     where the one or more electrical interconnections  250 ,  1210  are comprised (or positioned) between the first  310 ,  1410  and second  320 ,  1420  surfaces, and the conformable foil-like substrate  30 ,  1400  has a maximum thickness of 0.5 millimeter or less, proximate the first  200   a ,  200   b ,  1220  and second  400   a ,  400   b ,  1220  electrodes, the thickness being determined by a perpendicular distance between corresponding points on the first  310 ,  1410  and second planar surfaces  320 ,  1420 . 
     (ii). An implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1110 ,  1111  comprising:
         a substrate  300 ,  1400 , the substrate comprising a top surface  310 ,  1410  and a bottom surface  320 ,  1420 ;   a pulse generator  500  located along a first portion of the substrate  300 ,  1400 , the pulse generator  500  being configured to generate at least one stimulation pulse;   an electrode array  200 ,  400 ,  1220  comprising at least two electrodes  200 ,  400 ,  1220  located along a second, conformable portion of the substrate  300 ,  1400 ;   a plurality of electrical interconnections  250 ,  1210  electrically coupling the pulse generator  500  to the at least two electrodes of the electrode array  200 ,  400 ,  1220 , wherein the plurality of electrical interconnections  250 ,  1210  are positioned between the top  310 ,  1410  and bottom surfaces  320 ,  1420  of the substrate  300 ,  1400 ; and   an encapsulation layer covering at least part of the first portion of the substrate  300 ,  1400 ;   wherein a maximum thickness of the substrate  300 ,  1400  in the second portion is equal to or less than 0.5 millimeters.
 
(iii). An implantable electrical device  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1100 ,  1101 ,  1102  comprising:
   a substrate  300 ,  1400  having a first surface  310 ,  1410  and one or more electrical conductors  250 ,  1210 ;   a first biocompatible encapsulation layer  1300 ,  1310 ,  1320 ;   a first adhesion layer  1500 ,  1510 ,  1520 , disposed between the first surface  310 ,  1410  and the first encapsulation layer  1300 ,  1310 ,  1320 ;       

     wherein:
         the substrate  300 ,  1400  is configured and arranged to be substantially flexible;   the first adhesion layer  1500 ,  1510 ,  1520  is configured and arranged to conform to the first surface  310 ,  1410  and comprises a ceramic material;   the first encapsulation layer  1300 ,  1310 ,  1320  comprises a polydimethylsiloxane (PDMS) rubber, and   the first adhesion layer  1500 ,  1510 ,  1520  and the first encapsulation layer  1300 ,  1310 ,  1320  are configured and arranged to resist the ingress of fluids from a human or animal body into at least a portion of the first surface  300 ,  1410 .
 
(iv). A process for applying an encapsulation layer  1300 ,  1310 ,  1320  to a surface  310 ,  1410 ,  320 ,  1420  of a substantially flexible substrate  300 ,  1400 , the process comprising:
   providing a substrate  300 ,  1400  having a first surface  310 ,  1410  and one or more electrical conductors  250 ,  1210 ;   applying a first conformal adhesion layer  1500 ,  1510 ,  1520 , comprising a ceramic material, to at least a portion of the first surface  310 ,  1410 ;   applying a first biocompatible encapsulation layer  1300 ,  1310 ,  1320 , comprising a polydimethylsiloxane (PDMS) rubber to at least a portion of the first adhesion layer  1500 ,  1510 ,  1520 ;       

     wherein the first adhesion layer  1500 ,  1510 ,  1520  and the first encapsulation layer  1300 ,  1310 ,  1320  are configured and arranged to resist the ingress of fluids from a human or animal body into at least a portion of the first surface  310 ,  1410 . 
     (v). An implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1110 ,  1111  comprising: 
     a substrate  300 ,  1400  comprising a first surface  310 ,  1410  and a second surface  320 ,  1420 , wherein a thickness of the substrate  300 ,  1400  is defined by the first  310 ,  1410  and second  320 ,  1420  surfaces; 
     a pulse generator  500  being configured to generate at least one stimulation pulse; 
     at least two electrodes  200 ,  400   1220  located along a conformable portion of the substrate  300 ,  1400 ; 
     a plurality of electrical interconnections  250 ,  1210  electrically coupling the pulse generator  500  to the at least two electrodes  200 ,  400 ,  1220 ; 
     an encapsulation layer  1300 ,  1310 ,  1320  at least partially covering the substrate ( 300 ,  1400 ); and 
     an adhesion layer  1500 ,  1510 ,  1520  between the encapsulation layer  1300 ,  1310 ,  1320  and the substrate  300 ,  1400  in at least one location; 
     wherein the thickness of the substrate  300 ,  1400  along the conformable portion is equal to or less than 0.5 millimeters 
     (vi). An implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1110 ,  1111  comprising: 
     a substrate  300 ,  1400 , the substrate  300 ,  1400  comprising a top surface  310 ,  1410  and a bottom surface  320 ,  1420 ; 
     a pulse generator  500  located along a first portion of the substrate  300 ,  1400 , the pulse generator  500  being configured to generate at least one stimulation pulse; 
     at least two electrodes  200 ,  400 ,  1220  located along a second, conformable portion of the substrate  300 ,  1400 ; 
     a plurality of electrical interconnections  250 ,  1210  electrically coupling the pulse generator to the at least two electrodes  200 ,  400 ,  1220 ; 
     wherein the plurality of electrical interconnections  250 ,  1210  are positioned between the top  310 ,  1410  and bottom  320 ,  1420  surfaces of the substrate  300 ,  1400 ; 
     an encapsulation layer  1300 ,  1310 ,  1320  covering at least part of the first portion of the substrate  300 ,  1400 ; and 
     an adhesion layer  1500 ,  1510 ,  1520  between the encapsulation layer  1300 ,  1310 ,  1320  and the substrate  300 ,  1400  in at least one location; 
     wherein a maximum thickness of the substrate  300 ,  1400  in the second portion is equal to or less than 0.5 millimeters. 
     (vii). An implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1110 ,  1111  according to any disclosed example, wherein the maximum thickness of the implantable stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1110 ,  1111  proximate the pulse generator  500  is equal to or less than 5 millimeters, or is equal to or less than 4 millimeters, is equal to or less than 3 millimeters, the thickness being determined by a perpendicular distance between corresponding points on outer planar surfaces.
 
(viii) An implantable stimulator according to any disclosed example, wherein:
         the pulse generator  500  is located along a first portion of the substrate  300 ,  1400 ;   the electrode array  200 ,  400 ,  1220  is located along a second, conformable Liquid Crystal Polymer (LCP) portion of the substrate  300 ,  1400 ;   the plurality of electrical interconnections  250 ,  1210  are positioned on a first conformable LCP layer of the substrate  300 ,  1400  using electro-plating and/or a semiconductor deposition technique and at least one second conformable LCP layer of the substrate  300 ,  1400  is secured to the first layer so as to cover the plurality of electrical interconnections  250 ,  1210 ;   the encapsulation layer  1300 ,  1310 ,  1320  is biocompatible, covering the first portion and at least part of the second portion of the substrate  300 ,  1400 , the encapsulation layer  1300 ,  1310 ,  1320  comprising Polydimethylsiloxane (PDMS) and having a tensile strength in the range 6 to 8 MPa;   one or more biocompatible adhesion layers  1500 ,  1510 ,  1520  conform to the substrate  300 ,  1400  and are positioned between the encapsulation layer  1300 ,  1310 ,  1320  and the substrate  300 ,  1400 , wherein the one or more adhesion layers  1500 ,  1510 ,  1520  comprise a ceramic portion having an average thickness in the range of 25 nm to 200 nm that is applied using atomic layer deposition (ALD), and comprises at least one first layer comprising TiO2 and at least one second layer adjacent to the at least one first layer and comprising Al2O3;   the second portion of the substrate has a Young&#39;s modulus in the range 2500 to 3600 MPa;   the one or more adhesion layers  1500 ,  1510 ,  1520  and the encapsulation layer  1300 ,  1310 ,  1320  are configured to resist ingress of fluids onto the substrate  300 ,  1400 ;   the thickness of the substrate  300 ,  1400  along the second portion is equal to or less than 0.2 millimeters;   a thickness of the stimulator  100 ,  101 ,  102 ,  103 ,  104 ,  105 ,  1110 ,  1111  along the first portion is equal to or less than 4 millimeters; and   the pulse generator  500  comprises an energy receiver configured to wirelessly receive energy from an energy transmitter.       

     REFERENCE NUMERALS 
     
         
           100 ,  101 ,  102  implantable stimulators 
           103 ,  104 ,  105  further embodiments of implantable stimulators 
           200   a ,  200   b ,  200   c ,  200   d  one or more stimulation electrodes 
           250  one or more stimulation electrical interconnection layers 
           300  a conformable foil-like substrate 
           310 ,  320  a first and second surface 
           400 ,  400   a ,  400   b ,  400   c ,  400   d  one or more return electrodes 
           500  a pulse generator 
           600  a longitudinal axis 
           700  a first transverse axis 
           750  a second transverse axis 
           810  location for left supraorbital nerve or cortical stimulation 
           820  location for right supraorbital stimulation 
           830 ,  830   a ,  830   b  location for left occipital nerve stimulation 
           840 ,  840   a ,  840   b  location for right occipital nerve stimulation 
           850  location for deep brain stimulation 
           860  location for vagus nerve, carotid artery, carotid sinus, phrenic nerve or hypoglossal stimulation 
           865  location for cerebral spinal cord stimulation 
           870  location for peripheral nerve stimulation 
           875  location for spinal cord stimulation 
           880  location for gastric stimulation 
           885  location for sacral &amp; pudendal nerve stimulation 
           890  location for sacral neuromodulation 
           895  location for fibular nerve stimulation 
           910  left supraorbital nerve 
           920  right supraorbital nerve 
           930  left greater occipital nerve 
           940  right greater occipital nerve 
           1100 ,  1101 ,  1102  improved implantable electrical or electronic devices 
           1110 ,  1111  improved implantable medical devices 
           1130  a test substrate 
           1210  one or more electrical conductor 
           1220  one or more stimulation electrodes 
           1230  one or more sensors 
           1300  a further biocompatible encapsulation layer 
           1310  a first biocompatible encapsulation layer 
           1320  a second biocompatible encapsulation layer 
           1330  a third biocompatible encapsulation layer 
           1400  a substrate 
           1430  a silicon substrate 
           1435  a SiO2 (silicon dioxide) layer 
           1410  a first surface 
           1420  a second surface 
           1500  a further adhesion layer 
           1510  a first adhesion layer 
           1520  a second adhesion layer 
           1530  a third adhesion layer 
           1700  Bode plots presented as impedance magnitude 
           1701  Impedance magnitude for a bare IDC with exposed Pt metal 
           1702  Impedance magnitude for an IDC coated with HfO2 ALD 
           1703  Impedance magnitude for an IDC coated with an ALD-PDMS bilayer 
           1710  Bode plots presented as phase angle 
           1711  Phase angle for a bare IDC with exposed Pt metal 
           1712  Phase angle for an IDC coated with HfO2 ALD 
           1713  Phase angle for an IDC coated with an ALD-PDMS bilayer 
           1720  Adhesion monthly performance presented as impedance magnitude 
           1722   a ,  1722   b  Impedance magnitude for IDC&#39;s coated with HfO2 ALD 
           1723   a ,  1723   b  Impedance magnitude for IDC&#39;s coated with an ALD-PDMS bilayer 
           1730  Adhesion monthly performance presented as phase angle 
           1732   a ,  1732   b  Phase angle for IDC&#39;s coated with HfO2 ALD 
           1733   a ,  1733   b  Phase angle for IDC&#39;s coated with an ALD-PDMS bilayer  810  location for left supraorbital nerve or cortical stimulation 
           1750  Graph comparing the average pull force under dry conditions and after soaking 
           1761   a  Average peel force for sample 2.1 
           1762   a ,  1762   b  Average peel force for sample 2.2 
           1763   a ,  1763   b  Average peel force for sample 2.3 
           1764   a ,  1764   b  Average peel force for sample 2.4 
           1765   a ,  1765   b  Average peel force for sample 2.5