Shims for implants and methods of making and use thereof

Abstract

A shim attachable to an ICI for delivering electrical signals to the cortex and / or sensing cortical electrical signals. The shim includes one or more hollow passages passing therethrough or passages filed with an electrically conducting material for allowing electrical currents to pass through the passages. Effective thickness of the shim is adapted for a specific patient and a specific implantation site based on data obtained from anatomical or functional imaging method such as CT and MRI. Forms and dimensions of the passages may be configured for controlling the current density distribution under the shim by obtaining anatomical and physiological data for the specific patient using functional imaging methods such as, for example, fMRI. The shim may be used in for controlling current density distribution only in combination with another shim that controls the total thickness. Assemblies including a single part ICI or a two-part ICI and the shim are described.

Description

[0001] SHIMS FOR IMPLANTS AND METHODS OF MAKING AND USE THEREOF

[0002] RELATED APPLICATIONS

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 672,270 filed July 17, 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to the field of implants for delivering therapeutic electrical treatment to the brain of a patient, and more particularly to shims for such implants that are adapted for implantation in a specific patient and at a specific implantation region based on data obtained from the specific patient using anatomical imaging and / or functional imaging methods.

[0006] Brain recording and / or stimulating methods may be used for modulating the brain physiology to enhance cognitive function in healthy individuals or to improve cognitive function in some patients having neuropsychiatric diseases affecting cognitive performance such as, inter alia, depression, ADHD, OCD, Various eating disorders, epilepsy and many other psychiatric, neurodegenerative, neurological and neuropsychiatric disorders. Cortical sensing and stimulation may also be used to treat a wide array of motor disabilities.

[0007] Implants, systems and methods for sensing electrical brain activity and for delivering therapeutic electrical signals to the brain are disclosed, inter alia, in published international applications WO2019 / 130248, WO2019 / 244099, WG2020 / 050527, WO2020 / 161555

[0008] WO202 1 / 144730 and W02018 / 109715 incorporated herein by reference in their entirety.

[0009] Typically, when an intracalvarial implant is implanted in the bone of the skull of a patient, an incision is made in the scalp of the patient to allow access to the surface of the calvarial bone, a hole or recess is made in the calvarial bone and the implant is inserted into the hole or recess and fixated or securely attached to the calvarial bone. It is usually preferred that the top surface of the implant will be flush or nearly flush with the calvarial bone surface to avoid the forming of an unaesthetic “bump” or protrusion in the head of the patient.

[0010] A common problem with implants designed to be implanted in the calvarial bone of patients is the fact that the thickness of the calvarial bone varies depending, inter alia, on the age of the patient, the exact location of implantation of the implant in the calvarial bone, and individual anatomical differences in bone thickness. It is technically and logistically preferred to have a standardized implant instead of having to manufacture numerous implant sizes. One solution to the above problem is to use a shim placed over the implant. The implant has a standard thickness (height) and shims may have various thicknesses (heights) that may be easily manufactured. During surgery, the surgeon selects a shim having an appropriate thickness and places the shim on top of the implant to achieve flatness or near flatness of the skull’s surface after implantation. Published international applications W02020 / 050527, and WO2021 / 144730 disclose shims of various different thicknesses placeable on top of an intracalvarial implant. Implants designed for delivering electrical signals to the brain typically have a fixed stimulating electrode configuration. This may be a problem when it is desired to adapt the location of the electrical stimulation to account for individual differences in the exact position of such stimulation targets in different patients. For example, when fMRI scans are performed in different patients it is found that there are significant differences in the anatomical location of active cortical regions involved in the DAN network. For Example, such differences in DAN anatomical location may be seen in Figure 2 of the paper entitled “Resting state network mapping in individuals using deep learning.”, by Luckett PH, Lee J J, Park KY, Raut RV, Meeker KL, Gordon EM, Snyder AZ, Ances BM, Leuthardt EC, Shimony JS. Published in Front Neurol. 2023 Jan 12;13: 1055437. doi: 10.3389 / fneur.2022.1055437. PMID: 36712434; PMCID: PMC9878609.

[0011] ( w w w(dot)pubmed(dot)ncbi(dot)nlm(dot)nih(dot)gov / 36712434 / ) .

[0012] One possible solution to the problem is to use current steering methods to direct the electrical stimulating currents to selected cortical regions. For example, published international application WO2021 / 144730 discloses the use of current steering methods for modifying the stimulating current density by using a fixed stimulating electrode configuration on the implant and varying the stimulating current parameters applied to each of the fixed electrodes. However, in some cases the resolution achievable by using a small number of stimulating electrodes may be limited. While it may be possible to increase the spatial resolution of current steering methods by increasing the number of discrete electrodes in the implant this may come at the cost of reducing the surface area of each electrode which may put a limit on the amount of current that may be passed through each electrode. Such a problem may be exacerbated in miniature intra-calvarial implants that have limited surface area available for electrode placement, while at the same time may require the passing of substantial currents through each electrode in order to be able to penetrate a layer of the calvarial bone and stimulate cortical neurons.

[0013] There is, therefore, a need for shims that solve the above indicated problems, in a cost effective, easy to use, logistically effective and safe manner. SUMMARY OF THE INVENTION

[0014] There is therefore provided, in accordance with an embodiment of the shims of the present application, a shim, attachable to an intracalvarial implant (ICI). the ICI is implantable in a calvarial bone of a patient, the ICI includes a first ICI- side including one or more stimulating electrodes for electrically stimulating one or more brain regions of the patient and a second ICI side opposing the first-ICI side. The ICI also includes at least one current-return electrode and an electronics module electrically coupled to the one or more stimulating electrodes and to the at least one current-return electrode. The shim includes an electrically insulating shim body having a first shim-side attachable to the first ICI-side, and a second shim-side. The shim also includes one or more passages extending from the first shim-side to the second shim-side. The one or more passages are configured to allow electrical currents to flow from at least some of the one or more stimulating electrodes and to exit from the second shim-side and stimulate one or more stimulation targets of the one or more brain regions of the patient after the ICI and the shim attached thereto are implanted in the calvarial bone.

[0015] In accordance with some embodiments of the shim, the ICI also includes one or more sensing / recording electrodes that are electrically coupled to the electronics module. Some passages of the one or more passages of the shim allow the one or more sensing / recording electrodes to sense / record electrical signals from the patient’s brain.

[0016] In accordance with some embodiments of the shim, the shim is detachably attachable to the ICI.

[0017] In accordance with some embodiments of the shim, one or more shim parameters selected from, the number of the one or more passages, the shape of the one or more passages, the configuration of the one or more passages within the shim body, the arrangement of the one or more passages on the first shim-side and the arrangement of the one or more passages on the second shim-side are determined for a specific patient based on magnetic resonance imaging tomographic data acquired from the specific patient prior to implantation of the ICI.

[0018] In accordance with some embodiments of the shim, the magnetic resonance imaging tomographic data comprises data representative of regions in the brain of the specific patient that exhibit increase in neuronal activity when the specific patient is presented with a task requiring attention.

[0019] In accordance with some embodiments of the shim, the ICI has a standard effective thickness B and the effective thickness H of the shim is specifically determined for a specific patient such that the value of B+H is equal to a depth Z of an implantation recess made in a selected region of the calvarial bone of the specific patient. In accordance with some embodiments of the shim, the ICI has a standard thickness B, and the effective thickness H of the shim is determined for a specific patient such that when an assembly including the ICI and the shim attached thereto is implanted in a through-hole penetrating the entire thickness of the calvarial bone, the value of B+H is equal to the distance between an outer surface of the calvarial bone and a desired position of the second shim-side.

[0020] In accordance with some embodiments of the shim, the desired position of the second shimside is selected from, an outer surface of a dura matter or in close proximity thereto, a portion of an arachnoid matter, a surface of a pia matter or in close proximity thereto and a surface of the patient’s brain or in close proximity thereto.

[0021] In accordance with some embodiments of the shim, the shim body includes an attachment mechanism for attaching the shim to the ICI.

[0022] In accordance with some embodiments of the shim, the attachment mechanism is selected from: an adhesive for sealingly attaching the first side of the ICI to the first shim-side without covering the surface of any of the electrodes included in the first ICI-side, a bayonet attachment mechanism, a keyed bayonet attachment mechanism, a female thread formed in a recess on the first shim-side of the shim body for receiving a compatible male thread formed on the first ICI-side, and a male thread formed on the first shim- side of the shim body for being screwed into a compatible female thread formed in the first ICI-side.

[0023] In accordance with some embodiments of the shim, the attachment mechanism is a bayonet attachment mechanism selected from, two or more pins formed on the first shim-side of the shim-body, the pins are configured to be inserted into two or more matching receiving slots formed in the first ICI-side, two or more receiving slots formed in the shim body, the two or more receiving slots are configured to receive two or more pins protruding from the first ICI-side, two or more pins formed on the first shim-side of the shim body, the two or more pins have sizes and / or shapes different from each other, the two or more pins are adapted to be inserted into two or more compatible keyed receiving slots formed in the first ICI-side, for ensuring proper alignment of the shim with the ICI, two or more pins formed on the first ICI-side, the two or more pins have sizes and / or shapes different from each other, the two or more pins are adapted to be inserted into two or more compatible keyed receiving slots formed in the first shim- side for ensuring proper alignment of the shim with the ICI, two or more pins formed on the circumference of the shim body and configured to be inserted into two or more matching receiving slots formed in the inner surface of a recess formed in the first ICI-side, two or more pins formed on the inner surface of a recess formed within the first ICI-side, the two or more pins are configured to be inserted into two or more matching receiving slots formed in the circumference of a recess formed in the first shim-side, two or more differently sized and / or differently shaped pins formed on the circumference of the shim body and adapted to be inserted into two or more matching differently sized and / or differently shaped keyed receiving slots formed in an inner surface of a recess formed in the first ICI-side, for ensuring proper alignment of the shim with the ICI, and two or more differently sized and / or differently shaped pins formed on the circumference of the shim and adapted to be inserted into two or more matching differently sized and / or differently shaped keyed receiving slots formed in an inner surface of a recess formed in the first ICI-side, for ensuring proper alignment of the shim with the ICI.

[0024] In accordance with some embodiments of the shim, the shim also includes a perforated gasket attached thereto. The perforated sealing gasket has one or more perforations wherein at least one perforation of the one or more perforations is configured for circumscribing the circumference of at least one of the one or more stimulating electrodes of the ICI.

[0025] In accordance with some embodiments of the shim, the ICI includes multiple stimulating electrodes and the shim also includes a perforated sealing gasket attached thereto. The perforated sealing gasket has one or more perforations. At least one perforation of the one or more perforations is configured for circumscribing two or more electrodes of the multiple stimulating electrodes of the ICI.

[0026] In accordance with some embodiments of the shim, the ICI also includes one or more sensing / recording electrodes. Some of the one or more passages allow the one or more sensing / recording electrodes to sense / record electrical signals from the patient’s brain. The shim also includes a perforated sealing gasket attached thereto. The perforated sealing gasket has one or more perforations. Each sensing / recording electrode of the sensing / recording electrodes of the ICI is circumscribed by a perforation of the one or more perforations of the perforated gasket.

[0027] In accordance with some embodiments of the shim, the one or more passages are selected from, one or more hollow passages, one or more passages at least partially filled with an electrically conducting material, one or more passages with an electrical contact mechanism attached there within, one or more passages having a composite electrical contact mechanism attached therewithin the composite electrical contact mechanism includes an electrical contact mechanism and an electrically conducting material electrically connected to the electrical contact mechanism, and any non-mutually exclusive combinations thereof.

[0028] In accordance with some embodiments of the shim, the electrically conducting material is selected from an electrically conductive metal, an electrically conductive metallic alloy, an electrically conductive polymer, an electrically conducting hydrogel, and an electrically conductive gel.

[0029] In accordance with some embodiments of the shim, at least some passages of the one or more passages are hollow passages. Each hollow passage has at least one opening that opens at the first shim-side and at least one opening that opens at the second shim-side.

[0030] In accordance with some embodiments of the shim, each opening of the at least one opening on the first shim- side circumscribes one or more electrodes when the first shim- side is attached to the first ICI-side.

[0031] In accordance with some embodiments of the shim, the shim also includes a perforated sealing gasket having one or more perforations formed therein, at least some of the one or more passages are hollow passages, and the contour of each of the perforations circumscribes the at least one opening of the at least some hollow passages that are located on the first shim-side.

[0032] In accordance with some embodiments of the shim, the one or more passages are hollow passages and the one or more hollow passages are selected from, hollow passages having a single opening on the first shim-side and a single opening on the second shim-side, hollow passages having a single opening on the first shim-side and two or more openings on the second shim-side, hollow passages having two or more openings on the first shim-side and one opening on the second shim-side, and any non-mutually exclusive combinations thereof.

[0033] In accordance with some embodiments of the shim, the one or more passages are selected from: cylindrical passages, frustoconical passages, part frustoconical part cylindrical passages, tapering passages, irregularly shaped passages, bifurcating passages, branching passages, branching passages having one or more branches terminating at the first shim- side and one or more branches terminating at second shim- side, and any non-mutually exclusive combinations thereof.

[0034] In accordance with some embodiments of the shim, the one or more passages are selected from: branching hollow passages having a single opening on the first shim-side and a plurality of openings on the second shim-side, branching hollow passages having a plurality of openings on the first shim-side and a single opening on the second shim-side, and branching hollow passages having a plurality of openings on the first shim-side and a plurality of openings on the second shim-side.

[0035] In accordance with some embodiments of the shim, the one or more passages are selected from, hollow passages having a single opening having a first cross-sectional area on the first shimside and a single opening having a second cross-sectional area on the second shim-side, wherein the first cross-sectional area is equal to the second cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a single opening having a second cross-sectional area on the second shim-side, wherein the first cross-sectional area is larger than the second cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a single opening having a second cross-sectional area on the second shim-side, wherein the first cross-sectional area is smaller than the second cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a plurality of openings having a total combined cross-sectional area on the second shimside, wherein the first cross-sectional area is equal to the total combined cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a plurality of openings having a total combined cross-sectional area on the second shimside, wherein the first cross-sectional area is larger than the total combined cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a plurality of openings having a total combined cross-sectional area on the second shimside, wherein the first cross-sectional area is smaller than the total combined cross-sectional area, hollow passages having a plurality of openings having a total combined cross-sectional area on the first shim-side and a single opening having a second cross-sectional area on the second shim-side, wherein the total combined cross-sectional area is equal to the second cross-sectional area, hollow passages having a plurality of openings having a total combined cross-sectional area on the first shim-side and a single opening having a second cross-sectional area on the second shim-side, wherein the total combined cross-sectional area is smaller than the second cross- sectional area, hollow passages having a plurality of openings having a total combined cross-sectional area on the first shim-side and a single opening having a second cross-sectional area on the second shim-side, wherein the total combined cross-sectional area is larger than the second cross-sectional area, hollow passages having a first plurality of openings having a first total combined cross- sectional area on the first shim-side and a second plurality of openings having a second total combined cross-sectional area on the second shim-side, wherein the first total combined cross- sectional area is equal to the second total combined cross-sectional area, hollow passages having a first plurality of openings having a first total combined cross- sectional area on the first shim-side and a second plurality of openings having a second total combined cross-sectional area on the second shim-side, wherein the first total combined cross- sectional area is larger than the second total combined cross-sectional area, hollow passages having a first plurality of openings having a first total combined cross- sectional area on the first shim-side and a second plurality of openings having a second total combined cross-sectional area on the second shim-side, wherein the first total combined cross- sectional area is smaller than the second total combined cross-sectional area, passages having an electrical contact mechanism attached therein, passages having a composite electrical contact mechanism attached therein, passages partially filled or entirely filled with an electrically conducting material, passages including therein an electrical contact mechanism electrically coupled to a body comprising an electrically conducting material, and any non-mutually exclusive combinations thereof.

[0036] In accordance with some embodiments of the shim, the one or more stimulating electrodes of the first ICI-side are a plurality of stimulating electrodes and at least one passage of the one or more passages is selected from a hollow passage having a single opening having a cross-sectional area on the first shim-side, wherein when the shim is attached to the first ICI-side, the single opening circumscribes a single electrode or a portion of a single electrode within the cross- sectional area thereof, and a hollow passage having a single opening on the first shim- side. When the shim is attached to the first ICI-side, the single opening circumscribes two or more electrodes within the cross-sectional area thereof.

[0037] In accordance with some embodiments of the shim, the one or more electrodes of the first ICI-side are a single electrode having an electrode surface area and at least one passage of the one or more passages is a hollow passage having a single opening with a first cross-sectional area on the first shim-side. When the shim is attached to the first ICI-side, the single opening circumscribes only a portion of the surface area of the single electrode within the first cross-sectional area thereof.

[0038] In accordance with some embodiments of the shim, the shim body is selected from, a shim body made of or including a biocompatible ceramic material, a shim body made of or including biocompatible polymer-based material, a shim body covered with or coated with a biocompatible material, and a shim body covered with or coated with a biocompatible polymer-based material.

[0039] In accordance with some embodiments of the shim, the shim includes an alignment mechanism to ensure proper alignment of the shim with respect to the ICI after the shim is attached to the ICI.

[0040] In accordance with some embodiments of the shim, the alignment mechanism is selected from, two or more keyed notches formed in the shim and two or more corresponding protrusions formed on the ICI, two or more keyed notches formed in the ICI and two or more corresponding protrusions formed on the shim body, and a first alignment marker on the shim and a second alignment marker on the ICI.

[0041] In accordance with some embodiments of the shim, the effective thickness H of the shim is the thickness contributed by the shim to the total thickness of an assembly including the ICI and the shim attached to the ICI.

[0042] In accordance with some embodiments of the shim, the total thickness of the assembly excludes the thickness ST of any portion of the ICI that protrudes from the external surface of the calvarial bone after implantation.

[0043] In accordance with some embodiments of the shim, the effective thickness H of the shim includes the thickness of a contact pad protruding from the second shim-side.

[0044] In accordance with some embodiments of the shim, the shim is sealingly attachable to the first ICI-side to reduce current leakage through the attachment region between the first shim-side and the first ICI-side.

[0045] In accordance with some embodiments of the shim, the shim is manufactured using a method selected from, an additive manufacturing method, a subtractive manufacturing method, and a manufacturing process combining an additive manufacturing method and a subtractive manufacturing method. In accordance with some embodiments of the shim, the ICI is a two-part ICI including a first ICI-part and a second ICI-part attached to the first ICI-part.

[0046] In accordance with some embodiments of the shim, the first ICI-part includes the electronics module, the one or more stimulating electrodes, and at least one current-return electrode. The first ICI-part has a known standard effective thickness K. The second ICI-part includes a second part housing, a magnet disposed within the second part housing and an induction coil disposed within the second part housing and electrically couplable to the electronics module of the first ICI-part using two contact pads included in the second ICI-part. The second ICI-part has an effective thickness S.

[0047] In accordance with some embodiments of the shim, the effective thickness S of the second ICI-part is an effective thickness determined for each specific patient based on data obtained from using anatomical and functional tomographic imaging methods on the specific patient.

[0048] In accordance with some embodiments of the shim, the effective thickness S is a known standard effective thickness, and one or more shim parameters selected from, the effective thickness of the shim, the number of the one or more passages, the shape of the one or more passages, the configuration of the one or more passages within the shim body, the arrangement of the one or more passages on the first shim-side and the arrangement of the one or more passages on the second shim-side, are determined for a specific patient based on magnetic resonance imaging tomographic data and / or anatomical tomographic data acquired from the specific patient prior to implantation of the ICI.

[0049] In accordance with some embodiments of the shim, the effective thickness S of the second ICI-part is an effective thickness determined for each specific patient based on data obtained from using anatomical and / or functional tomographic imaging methods on the specific patient, and one or more shim parameters selected from, the effective thickness of the shim, the number of the one or more passages, the shape of the one or more passages, the configuration of the one or more passages within the shim body, the arrangement of the one or more passages on the first shim-side and the arrangement of the one or more passages on the second shim-side are determined for the specific patient based on magnetic resonance imaging tomographic data and / or anatomical tomographic data acquired from the specific patient prior to implantation of the ICI.

[0050] There is also provided an implantable assembly including the ICI and the shim attached together.

[0051] There is also provided, in accordance with an embodiment of the methods of the present application, a method for producing a shim that includes the steps of: providing an ICI having a standardized stimulating electrode configuration for delivering electrical stimuli to the brain of a specific patient; obtaining magnetic resonance imaging tomographic data representative of areas in the patient’ s brain that exhibit increase in neuronal activity when the specific patient is presented with a task requiring attention; determining from the magnetic resonance imaging tomographic data one or more brain target regions requiring electrical stimulation; and producing the shim by configuring the one or more passages of the shim for selectively directing the electrical stimuli to the one or more one or more brain regions of the patient requiring electrical stimulation.

[0052] In accordance with some embodiments of the method, the step of producing is selected from the steps of, producing a personally adapted shim by using an additive manufacturing process, producing a personally adapted shim by using a subtractive manufacturing process, and producing a personally adapted shim by using a hybrid manufacturing process combining one or more additive manufacturing steps and one or more subtractive manufacturing steps.

[0053] In accordance with some embodiments of the method, the step of producing also includes the step of filling the one or more passages with an electrically conducting material.

[0054] In accordance with some embodiments of the method, the step of filling includes filling the one or more passages with a material selected from an electrically conducting gel and an electrically conducting polymer.

[0055] In accordance with some embodiments of the method, the step of filling includes filling the one or more passages with a liquid including precursors for forming an electrically conducting polymer and polymerizing the precursors to form a solid electrically conducting polymer within the one or more passages.

[0056] In accordance with some embodiments of the method, the step of producing includes the steps of, arranging within a mold one or more electrically conducting members having a desired shape, filling the mold with a liquid including at least one monomer, and polymerizing the at least one monomer to form a shim body including the one or more electrically conducting members passing therethrough.

[0057] In accordance with some embodiments of the method, the step of producing include the steps of: Providing a shim body having the desired dimensions of the shim, machining the shim body to form one or more hollow passages passing therethrough, and sealingly attaching within the one or more hollow passages one or more electrically conducting members formed to match the shape of the one or more hollow passages.

[0058] In accordance with some embodiments of the method, the one or more electrically conducting members are selected from, metallic members, metal coated members and members comprising an electrically conducting polymer.

[0059] The is also provided, in accordance with an embodiment of the methods of the present application, a method for determining the effective thickness H of a shim made for a specific patient. The shim has a first shim- side attachable to an ICI implantable in a calvarial bone of the specific patient and a second shim- side adapted for facing a brain stimulation target. The ICI has a known effective thickness B. The method includes the steps of: obtaining anatomical and / or functional tomographic imaging data by using on the specific patient one or more tomographic anatomical and / or functional imaging methods to image the head of the specific patient; using the anatomical and / or functional tomographic imaging data to determine a distance D between the outer surface of the patient’s calvarial bone of the patient and a desired position of the second shim- side after implantation; and calculating H from D and B, such that H = D-B.

[0060] In accordance with some embodiments of the method, the method also includes the step of manufacturing the shim having an effective thickness H.

[0061] In accordance with some embodiments of the method, the desired position of the second shim-side is selected from the following positions:

[0062] 1) A position in contact with at least a portion of a bottom of a recess made in the calvarial bone of the specific patient or in close proximity to the bottom of the recess,

[0063] 2) A position in contact with at least a portion of an outer surface of a dura matter or in close proximity thereto,

[0064] 3) A position in contact with at least a portion of an arachnoid matter or in close proximity thereto,

[0065] 4) A position in contact with at least a portion of a surface of a pia matter or in close proximity thereto, and

[0066] 5) A position in contact with at least a portion of a surface of the patient’s brain or in close proximity thereto.

[0067] The is also provided, in accordance with an embodiment of the methods of the present application, a method for implanting in a patient an assembly including an ICI and a shim, the method includes the steps of: 1) Providing a shim specifically manufactured for the patient and providing an ICI, the ICI includes one or more stimulating electrodes, one or more current return electrodes, and an electronics module suitably electrically coupled to the one or more stimulating electrodes and to the one or more current return electrodes. The ICI has a first ICI-side attachable to a first shimside and a second ICI-side opposing the first ICI-side and attachable to an outer surface of a calvarial bone of the patient. The ICI has a standardized effective thickness B and the shim has an effective thickness H. The shim has a first shim-side attachable to the first ICI-side and a second shim-side. The shim includes one or more passages extending from the first shim-side to the second shim- side.

[0068] 2) Surgically exposing the outer surface of the calvarial bone of the patient by making an incision in a scalp of the patient.

[0069] 3) Surgically forming in the calvarial bone a recess having a depth (B+H) and a recessbottom.

[0070] 4) Inserting the assembly including the ICI and the shim attached thereto into the recess, and

[0071] 5) Attaching the ICI or the assembly to the calvarial bone, such that after the step of attaching, the second shim-side is in contact with at least part of the recess-bottom or is in close proximity to the recess-bottom.

[0072] In some embodiments, the method also includes the step of closing the incision made in the step of surgically exposing.

[0073] In some embodiments, the ICI also includes one or more sensing / recording electrodes disposed in (or on) the first ICI-side and operatively connected to the electronics module of the ICI, and some passages of the shim are configured for allowing recording electrical signals from the patient’s brain.

[0074] There is also provided, in accordance with an embodiment of the methods of the present application a method for implanting in a calvarial bone of a specific patient an assembly including an ICI and a shim. The method includes the steps of:

[0075] 1) providing a shim specifically manufactured for the specific patient. The shim has a thickness H determined by using one or more anatomical and / or functional imaging methods performed on the specific patient. The ICI includes one or more stimulating electrodes, one or more current return electrodes, and an electronics module suitably electrically coupled to the one or more stimulating electrodes and to the one or more current return electrodes. The ICI has a first ICI-side attachable to the shim and a second ICI-side. The ICI is attachable to the calvarial bone. The ICI has a known standardized effective thickness B. The shim has a first shim-side attachable to the first ICI-side and a second shim-side. The shim includes one or more passages extending from the first shim-side to the second shim-side.

[0076] 2) Surgically exposing the outer surface of the calvarial bone of the patient by making an incision in a scalp of the patient.

[0077] 3) Surgically forming in the calvarial bone a through-hole spanning the entire thickness of the calvarial bone.

[0078] 4) Inserting the assembly into the through-hole; and

[0079] 5) Attaching the ICI or the assembly to the calvarial bone of the patient such that after the attaching, the second shim-side is in contact with at least a portion of a brain tissue underlying the through-hole or is in close proximity to the brain tissue.

[0080] In accordance with some embodiments the brain tissue is selected from:

[0081] 1) An outer surface of the dura matter of the patient.

[0082] 2) An arachnoid matter of the patient.

[0083] 3) An outer surface of a pia matter of the patient, and

[0084] 4) A surface of the patient’s brain.

[0085] In accordance with some embodiments the method also includes the step of closing the incision made in the step of surgically exposing.

[0086] In accordance with some embodiments the ICI also includes one or more sensing / recording electrodes disposed in (or on) the first ICI-side and operatively connected to the electronics module of the ICI. Some passages of the one or more passages of the shim are configured for allowing recording electrical cortical signals from the patient’ s brain.

[0087] The is also provided, in accordance with an embodiment of the kits of the present application, an individualized kit attachable to a first ICI-part of an intracalvarial two-part ICI implantable in an implantation space within the calvarial bone of the skull of a patient. The two-part ICI has a first ICI-part including an electronics module, one or more stimulating electrodes electrically coupled to the electronics module and one or more current-return electrodes electrically coupled to the electronics module. The first ICI-part has a first side including the one or more stimulating electrodes and a second side opposing the first side of the first ICI-part. The two-part ICI has a second ICI-part attachable to the first ICI-part. The first ICI-part has a standard thickness K. The kit includes:

[0088] 1) A shim having an electrically insulating shim body, the shim body has a first shim-side attachable to the first side of the first ICI-part and a second shim-side opposing the first shim-side. The shim body has an effective thickness H. The shim body has one or more passages extending from the first shim-side to the second shim-side, and 2) A second ICI-part having a first side attachable to the second side of the first ICI-part and a second side attachable to the calvarial bone. The second ICI-part has an effective thickness S. The effective thicknesses H and S are specifically adapted for an individual patient so that the sum K+H+S is such that when an assembly including the first ICI-part, the second ICI-part and the shim is inserted into a recess formed in the calvarial bone and having a recess depth equal to the sum K+H+S, and a recess -bottom, and the second side of the second ICI-part is attached to the calvarial bone, the second shim-side is in contact with at least part of the recess-bottom or in close proximity to the recess-bottom.

[0089] In accordance with some embodiments of the kit, the second ICI-part includes a permanent magnet disposed therein.

[0090] In accordance with some embodiments of the kit, the second ICI-part is selected from:

[0091] 1) A second ICI-part having a permanent magnet embedded therein.

[0092] 2) A second ICI-part having a hollow space formed therein for placing a permanent magnet therein and an openable and closable lid for closing the hollow space.

[0093] 3) A second ICI-part including an induction coil disposed or embedded therein, the induction coil includes two electrical contacts terminating on the surface of the first side of the second ICI- part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part, and

[0094] 4) A second ICI-part including a permanent magnet and an induction coil, the induction coil includes two electrical contacts terminating on the surface of the first side of the second ICI-part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part.

[0095] In accordance with some embodiments of the kit, the one or more passages are selected from:

[0096] 1) One or more hollow passages for allowing electrical signals to pass through the one or more hollow passages,

[0097] 2) One or more passages at least partially filled with an electrically conducting material,

[0098] 3) One or more passages having an electrical contact mechanism attached therewithin,

[0099] 4) One or more passages having a spring-loaded electrical contact mechanism attached therewithin,

[0100] 5) One or more passages having a composite electrical contact mechanism attached therewithin the composite electrical contact mechanism includes an electrical contact mechanism and an electrically conducting material electrically connected to the electrical contact mechanism, and 6) Any non-mutually exclusive combinations of 1-5 above.

[0101] In accordance with some kit embodiments, the electrically conducting material is selected from, an electrically conductive metal, an electrically conductive metallic alloy, an electrically conductive polymer and an electrically conductive gel.

[0102] There is also provided, in accordance with an embodiment of the kits of the present application, an individualized kit attachable to a first ICI-part of an intracalvarial two-part ICI implantable within the calvarial bone of the skull of a patient. The two-part ICI has a first ICI- part including an electronics module, one or more stimulating electrodes electrically coupled to the electronics module, and one or more current-return electrodes electrically coupled to the electronics module. The first ICI-part has a first side including the one or more stimulating electrodes and a second side opposing the first side. The two-part ICI has a second ICI-part attachable to the first ICI-part. The first ICI-part has a standard thickness K. The individualized kit includes:

[0103] 1) A shim having an electrically insulating shim body. The shim body has a first shim-side attachable to the first side of the first ICI-part and a second shim-side opposing the first shim-side. The shim body has an effective thickness H. The shim body has one or more passages extending from the first shim- side to the second shim- side, and

[0104] 2) A second ICI-part having a first side attachable to the second side of the first ICI-part and a second side attachable to the calvarial bone. The second ICI-part has an effective thickness S, wherein the effective thicknesses H and S are specifically adapted for an individual patient so that the sum K+H+S is such that when an assembly including the first ICI-part, the second ICI-part and the shim is inserted into a through-hole made in the calvarial bone, the through-hole spanning the entire thickness of the calvarial bone, and the second side of the second ICI-part is attached to the calvarial bone, the second shim-side is in contact with at least part of a brain tissue or is in close proximity to the brain tissue, wherein the brain tissue is selected from: an outer surface of the dura matter of the patient, an arachnoid matter of the patient, an outer surface of a pia matter of the patient, and a surface of the patient’s brain. in accordance with some kit embodiments, the second ICI-part includes a permanent magnet disposed therein. in accordance with some kit embodiments, the second ICI-part is selected from:

[0105] 1) A second ICI-part having a permanent magnet embedded therein. 2) A second ICI-part having a hollow space formed therein for placing a permanent magnet therein and an openable and closable lid for closing the hollow space,

[0106] 3) A second ICI-part comprising an induction coil disposed or embedded therein, the induction coil includes two electrical contacts terminating on the surface of the first side of the second ICI-part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part, and

[0107] 4) A second ICI-part including a permanent magnet and an induction coil. The induction coil includes two electrical contacts terminating on the surface of the first side of the second ICI-part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part. in accordance with some kit embodiments, the one or more passages are selected from,

[0108] 1) one or more hollow passages for allowing electrical signals to pass through the one or more hollow passages,

[0109] 2) one or more passages at least partially filled with an electrically conducting material,

[0110] 3) one or more passages having an electrical contact mechanism attached therewithin,

[0111] 4) one or more passages having a spring-loaded electrical contact mechanism attached therewithin,

[0112] 5) one or more passages having a composite electrical contact mechanism attached therewithin the composite electrical contact mechanism includes an electrical contact mechanism and an electrically conducting material electrically connected to the electrical contact mechanism, and

[0113] 6) any non-mutually exclusive combinations of 1-5. in accordance with some kit embodiments, the electrically conducting material is selected from, an electrically conductive metal, an electrically conductive metallic alloy, an electrically conductive polymer and an electrically conductive gel.

[0114] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0115] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings, in which like components are designated by like reference numerals. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced. In the drawings:

[0116] FIG. 1 is a schematic isometric view illustrating a prior art intracalvarial implant (ICI) for sensing electrical signals in the cortex of a patient and for delivering therapeutic electrical signals to the brain of the patient;

[0117] FIG. 2 is a schematic bottom view illustrating the prior art ICI of FIG. 1;

[0118] FIG. 3 is a schematic isometric view illustrating a shim useable with the ICI of FIGS. 1-2;

[0119] FIG. 4 is a schematic isometric exploded view of the ICI of FIGS.1-2 and the shim of FIG. 3 aligned prior to attaching the shim to the ICI;

[0120] FIG. 5 is a schematic isometric view of an assembly including the ICI of FIG. 1 and the shim of FIG 3 attached thereto, prior to implantation;

[0121] FIG. 6 is a schematic cross-sectional diagram, illustrating an ICI and shim assembly implanted in a recess formed in the calvarial bone without penetrating the calvarial bone;

[0122] FIG. 7 is a schematic cross-sectional diagram, illustrating an ICI and shim assembly implanted in a hole passing through the entire thickness of the calvarial bone, such that the shim touches the dura matter;

[0123] FIGS. 8-9 are schematic cross-sectional diagrams, illustrating two different embodiments of shims having passages filled with electrically conducting materials and ICIs attachable to the shims;

[0124] FIG. 10 is a schematic bottom view illustrating an ICI having an array of stimulating electrodes;

[0125] FIG. 11 is a schematic cross-sectional view of the ICI of FIG. 10 taken along the lines XI- XI;

[0126] FIGS. 12, 13, 14, 15, 16 and 17 are schematic cross-sectional diagrams, each illustrating the ICI of FIG. 11 and a compatible shim attachable to the ICI and having multiple, differently shaped hollow passages, in accordance with some embodiments of the shims of the present application.

[0127] FIG. 18 is a schematic cross-sectional diagram illustrating the ICI of FIGS. 10 and 11 and a compatible shim attachable to the ICI and having multiple, differently shaped hollow passages, in accordance with some embodiments of the shims of the present application.

[0128] FIG. 19 is a schematic top view illustrating a first side of the shim that is attachable to the ICI of FIGS.10-11;

[0129] FIG. 20 is a schematic bottom view illustrating a second side of the shim of FIGS. 18 and 19.

[0130] FIG. 21 is a schematic cross-sectional view, illustrating an assembly including an ICI and a shim, the shim having an attachment mechanism formed as a female threaded portion of the shim, in accordance with an embodiment of the shims of the present application; FIG. 22 is a schematic cross-sectional view, illustrating an assembly including an ICI and a shim, the shim having an attachment mechanism formed as a male threaded portion of the shim, in accordance with an embodiment of the shims of the present application;

[0131] FIG. 23 is a schematic cross-sectional diagram, illustrating a shim including a keyed bayonet type attachment mechanism including two side-pins, in accordance with an embodiment of the shims of the present application;

[0132] FIG. 24 is a bottom view of an ICI including two locking slots usable for receiving the sidepins of the shim of FIG. 23;

[0133] FIG. 25 is a schematic cross-sectional view of the ICI of FIG. 24, taken along the lines XXV- XXV;

[0134] FIG. 26 is a schematic isometric view of the ICI of FIG. 24;

[0135] FIG. 27 is a schematic cross-sectional diagram illustrating a shim including a keyed bayonet type attachment mechanism including two securing members, in accordance with an embodiment of the shims of the present application;

[0136] FIG. 28 is a schematic bottom view of an ICI including two keyed recesses for receiving the two securing members of the shim of FIG. 27 ;

[0137] FIG. 29 is a schematic cross-sectional view of the ICI of FIG. 28, taken along the lines XXIX- XXIX;

[0138] FIG. 30 is a schematic top view of a shim having a keyed bayonet type attaching mechanism including two keyed recesses, in accordance with an embodiment of the shims of the present application;

[0139] FIG. 31 is a schematic cross-sectional of the shim of FIG. 30, taken along the lines XXXI- XXXI;

[0140] FIG. 32 is a schematic cross-sectional view illustrating an ICI attachable to the shim of FIGS. 30-31;

[0141] FIG. 33 is a schematic cross-sectional diagram illustrating a step of a method for making the shim of FIG. 8, in accordance with an embodiment of the methods of manufacturing the shims of the present application;

[0142] FIG. 34 is a schematic cross-sectional view, illustrating a step of a method for making the shim of FIG. 9;

[0143] FIG. 35 is a schematic isometric view illustrating a shim having branching hollow passages having multiple lumen branches, in accordance with an embodiment of the shims of the present application; FIG. 36 is a schematic cross-sectional view illustrating an assembly including a two-part ICI and a shim attached thereto implanted within a recess made in the calvarial bone of a patient, in accordance with an embodiment of the shims of the present application;

[0144] FIG. 37 is a schematic cross-sectional view illustrating an assembly including a two-part ICI and a shim attached thereto that are implanted in a hole passing through the calvarial bone of a patient with a side of the shim reaching the dura matter, in accordance with an embodiment of the shims of the present application;

[0145] FIG. 38 is a schematic cross-sectional view illustrating an ICI having a single stimulating electrode and a current return electrode attached to a compatible shim, in accordance with an embodiment of the ICIs and shims of the present application;

[0146] FIG. 39 is a schematic cross-sectional view illustrating a shim having passages filled with an electrically conducting solid material, in accordance with an embodiment of the shims of the present application;

[0147] FIG. 40 is a schematic cross-sectional view illustrating a shim including spring-loaded electrical contact mechanisms, in accordance with an embodiment of the shims of the shims of the present application;

[0148] FIG. 41 is a schematic bottom view illustrating an ICI attachable to the shim illustrated in FIGS. 43-45;

[0149] FIG. 42 is a schematic cross-sectional view of the ICI of FIG. 41, taken along the lines XLII- XLII;

[0150] FIG. 43 is a top view illustrating a shim including four hollow passages and four passages including spring loaded electrical contact mechanisms, in accordance with an embodiment of the shims of the present application;

[0151] FIG. 44 is a schematic cross-sectional view illustrating the shim of FIG. 43, taken along the lines XLIV-XLIV;

[0152] FIG. 45 is a schematic bottom view illustrating the shim of FIG. 43;

[0153] FIG. 46 is a schematic isometric view illustrating the spring 1355B of FIG. 44;

[0154] FIGS. 47, 48 and 49 are schematic cross-sectional views illustrating three different types of spring-loaded electrical contact mechanisms usable in some embodiments of the shims of the present application;

[0155] FIG. 50 is a schematic block diagram illustrating the steps of a method for determining in a specific patient the effective thickness of a shim of the present application, in accordance with an embodiment of the methods of the present application; FIG. 51 is a schematic block diagram illustrating a method for implanting in a patient an assembly including an ICI and a shim, in accordance with an embodiment of the methods of the present application;

[0156] FIG. 52 is a schematic block diagram illustrating a method for implanting in a patient an assembly including an ICI and a shim, in accordance with an embodiment of the methods of the present application; and

[0157] FIG. 53 is a schematic block diagram illustrating the steps of a method for producing a shim in accordance with an embodiment of the methods of the present application. DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION Abbreviations:

[0158] The following abbreviations are used throughout the specification and the claims of the present application:

[0159] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will prevail. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0160] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. As used herein the term “about” refers to ± 10 %. The word "exemplary" is used herein to mean "serving as an example, instance or illustration." Any embodiment described as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0161] The word "optionally" is used herein to mean "is provided in some embodiments and not provided in other embodiments." Any particular embodiment of the invention may include a plurality of "optional" features unless such features conflict.

[0162] The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to". The term “consisting of’ means “including and limited to”.

[0163] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0164] The term Intra-calvarial implant (ICI) is used throughout the present application and the claims to mean an implant having one or more stimulating electrodes and one or more current return electrodes, that is implanted in the calvarial bone of a human skull or passes through the calvarial bone and penetrates the calvarial bone. Such an implant may also have one or more sensing / recording electrodes for sensing and / or recording electrical signals generated in the cortex. Some or all of the electrodes of the intracalvarial implant may be within the calvarial bone (without breaching the inner table of the calvarial bone). However, in some embodiments of such an intracalvarial implant, part of the implant penetrates the calvarial bone such that some or all the electrodes of the implant are positioned above or in contact with the dura matter, the arachnoid matter or the pia matter of the meninges or the cortical surface itself.

[0165] The term “stimulating” is used throughout the present application and the claims to mean delivering an electrical current to a cortical tissue for causing either neuronal excitation or neuronal inhibition (or both excitation of some neurons and inhibition of some neurons of the stimulated target tissue), depending, inter alia, on the polarity of the applied electrical signal and on the types of neurons in the stimulated tissue.

[0166] The term “stimulating electrode” in its singular and plural forms is used throughout the present application and the claims to mean an electrode capable of passing an electrical current into a target tissue irrespective of the polarity of the current.

[0167] The term “stimulating current” in its singular and plural forms is used throughout the present application and the claims to mean an electrical current passed into a tissue irrespective of the polarity of the current.

[0168] The term “stimulation target” is used throughout the present application and the claims to mean a tissue region or tissue part that may be targeted for receiving a stimulating current.

[0169] The term “current return electrode” is used throughout the present application and the claims to mean an electrode that may function as a current sink or as a current source with respect to one or more stimulating electrodes.

[0170] The term “total thickness” is used with respect to an assembly including an ICI and a compatible shim attached to the ICI to mean the thickness of the implanted assembly as measured from the surface of the calvarial bone (after implantation) to the side of the shim closest to the cortex.

[0171] The term “effective thickness” is used with respect to an ICI throughout the application and the claims to mean the thickness (as measured from the outer surface of the calvarial bone when the ICI is attached to the outer surface of the calvarial bone) that is contributed by the ICI to the total thickness of an assembly including the ICI and a compatible shim attached thereto.

[0172] The term “effective thickness” is used with respect to a shim throughout the application and the claims to mean the thickness that is contributed by the shim to the total thickness of an assembly including the shim and a compatible ICI attached thereto.

[0173] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0174] Throughout this application and claims, the term "plurality" means "two or more".

[0175] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0176] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals there between.

[0177] Reference is now made to FIGS. 1 and 2 which are a schematic isometric view and a bottom view, respectively, illustrating a prior art intracalvarial implant (ICI) for sensing electrical signals in the cortex of a patient and for delivering therapeutic electrical signals to the brain of the patient.

[0178] The construction and operation of ICIs similar (but not identical) to the ICI 10 are described in detail in International published application WO 2021 / 144730 and are not the subject matter of the present application. Briefly, the ICI 10 has a first ICI-side 11A and a second ICI-side 11B opposing the first ICI-side 11 A. The ICI 10 includes a cylindrical housing 24 having a first side 24A that includes four stimulating electrodes 30A, 30B, 30C and 30D positioned on the first ICI-side 11A for delivering electrical stimulating currents to the cortex and four sensing electrodes 25 A, 25B, 25C and 25D and a reference electrode 30E for performing sensing cortical electrical signals. In some embodiments, the electrode 30E may be a stimulating electrode and a reference electrode (not shown) may be disposed on or within the second side 24B of the housing 24.

[0179] The housing 24 has a second side 24B that may be flush or nearly flush with the outer surface of the calvarial bone (not shown) after implantation. The ICI 10 also includes side-tabs 34A and 34B that protrude from a third side 24 of the ICI 10. The side-tabs 34A and 34B have screw holes 34C and 34D, respectively formed therein. After implantation of the ICI 10, the ICI 10 may be firmly attached to the outer surface of the calvarial bone by screwing two suitable bone screws (not shown) into the calvarial bone through the screw holes 34C and 34D. The ICI 10 also includes an annular current return electrode 30F disposed on or embedded within the third side 24C of the ICI 10. The current return electrode 30F may be operated as a current source or a current sink (depending on the polarity of the stimulating electrical currents) for the stimulating electrodes 30A, 30B, 30C, 30D and (optionally) 30E.

[0180] Reference is now made to FIGS. 3-5. FIG. 3 is a schematic isometric view illustrating a shim useable with the ICI of FIGS. 1-2. FIG. 4 is a schematic isometric exploded view of the ICI of FIGS. 1-2 and the shim of FIG. 3 aligned prior to attaching the shim to the ICI. FIG. 5 is a schematic isometric view of an assembly including the ICI of FIG. 1 and the shim of FIG 3 attached thereto, prior to implantation.

[0181] The shim 20 has a shim body 22. The shim 20 has a first shim- side 21 A attachable to the first ICI-side 11A and a second shim-side 2 IB opposing the first shim-side 21 A. The shim body 22 may be made from or may be covered with or coated with an electrically non-conducting biocompatible material. For example, the shim body 22 may be made from a biocompatible ceramic material or a suitable biocompatible polymer. Such biocompatible ceramic materials may include but are not limited to, Alumina, Zirconia, doped Zirconia and Titania. Biocompatible polymers may include various Polyether polyester co-polymers, Polyethyleneterephtalate (PET), poly ether ether ketone (PEEK), Kapton ®, or any other suitable high-performance polymer.

[0182] Turning to FIG. 5, in some embodiments, the shim 20 may be attached to the ICI 10 by using a suitable non-electrically conducting, biocompatible adhesive (not shown in FIG. 5 for the sake of clarity of illustration). The adhesive may be applied to some areas of the surface of the first ICI-side 11A of the ICI 10 with care being taken to avoid covering the surface of any of the electrodes 25A-25D, 3OA-3OD and 30E. Additionally or alternatively, the adhesive may be applied to the surface of the first side 22A of the shim body 22. After proper alignment of the ICI 10 and the shim 20, the ICI 10 and the shim 20 may be pressed together such that the openings of the hollow passages 40A-40D, 45A-45D and 40E oppose the electrodes 3OA-3OD, 25A-25B and 30E, respectively. The adhesive may then be allowed to set or may be cured using ultraviolet or visible light radiation. Examples of biocompatible adhesives that may be used are cyanoacrylates, polymethylmethacrylate and epoxy resins. If the shim body 22 is made of a material that is transparent to ultraviolet radiation, a UV curable adhesive may be used and the adhesive may be cured by exposing the second side 22B of the shim body 22 to UV radiation. If the shim body 22 is made of a material that is transparent to visible light, the adhesive may be a LED light-curable adhesive may be used and the adhesive may be cured by exposing the second side 22B of the shim body 22 to LED light radiation of specified spectrum.

[0183] As the shim 20 needs to be properly aligned with respect to the electrodes of the ICI 10 during attachment, the ICI 10 may include a first alignment marker 35 that may be implemented as a colored line 35 painted or printed on the side 24C of the housing 20 of the ICI 10. The Shim 20 may include a second alignment marker 36 that may be implemented as a colored line 36 painted or printed on the side 22C of the body 22 of the shim 20. When attaching the shim 20 to the ICI 10, the shim 20 is radially rotated until the second alignment marker 36 is aligned with the first alignment marker 35 prior to making the shim 20 contact the ICI 10. This method of alignment ensures that the passages within the body 22 are correctly aligned with respect to the electrodes of the ICI 10. Such an alignment method is effective even in cases in which the openings of the passages on the first side of the shim body 22 are not symmetrically arranged on the side 22A of the shim body 22 and / or are not of the same size (see, for example, the passages of FIGS 12-15 and 17 hereinafter). FIG. 5 shows the position of the first alignment marker 35 and the second alignment marker 36 after attaching the shim 20 to the ICI 10.

[0184] In some embodiments, the shim body 22 may be a disc-like or cylindrical body having a circular cross-section and a thickness H. The shim body 22 includes four hollow passages 40A- 40D extending from the first side 22A to the second side 22B of the shim body 22. The shim body 22 also includes four hollow passages 45A-45D and a hollow passage 40E extending from the first side 22A to the second side 22B of the shim body 22. The effective thickness of the shim body 22 is also H. In some embodiments, the shape and size of the openings of the hollow passages 40A-40D, 45A-45D and 40E on the first side 22A of the shim 22 may match the shape and size of the electrodes 3OA-3OD, 25A-25D and 30E, respectively. When the shim 22 is made, H may be specified such that H+B is equal or about equal to the depth of an implantation channel or recess (the implantation channel or recess are not shown in FIGS. 1-3 for the sake of clarity of illustration) made in the calvarial bone of the individual patient such that when the ICI and the shim are implanted, the second side 4B of the ICI 10 is flush or nearly flush with an outer surface of the calvarial bone.

[0185] Before implanting the ICI 10 in the calvarial bone of a patient, measurements for collecting data are performed in each individual patient. The measurements may include using fMRI to determine the regions that need to be stimulated in the cortex of the patient. For example, in implants delivering anti-depressive electrical therapy, the fMRI may be performed to locate regions in the DLPFC of the patient that need to be electrically stimulated to treat depressive episodes.

[0186] Other regions that may be stimulated to treat depression that may be located using fMRI may include the Subgenual Anterior Cingulate Cortex (sgACC) (by deep brain stimulation), the Medial Prefrontal Cortex (mPFC), the Lateral Orbitofrontal Cortex (1OFC), the Anterior Insula, the Medial Orbitofrontal Cortex (mOFC) and cortical regions associated with Ventral attention network, dorsal attention network and central executive network.

[0187] After determining the cortical locations that need to be stimulated, additional imaging methods such as CT or regular MRI may be used to determine the thickness of the calvarial bone overlying the region to be stimulated. In some embodiments, the distance from the inner surface of the inner table of the calvarial bone to various different tissues underlying the calvarial bone may be measured, such as, for example, the distance between the inner surface of the inner table of the calvarial bone to the surface of the dura matter and the thickness of the arachnoid matter. These measurements are performed in the region of the planned implantation of the ICI 10.

[0188] The results of the above measurements may be used to calculate the effective thickness of the shim 10 (or any other of the shims disclosed in the present application) and may also be used to determine the shape, structure, number and configuration of the passages passing within the shim as is disclosed in detail hereinafter for various different shim embodiments.

[0189] Reference is now made to FIGS. 6 and 7. FIG. 6 is a schematic cross-sectional diagram, illustrating an ICI and shim assembly implanted in a recess formed in the calvarial bone without penetrating the calvarial bone. FIG. 7 is a schematic cross-sectional diagram, illustrating an ICI and shim assembly implanted in a hole passing through the entire thickness of the calvarial bone, such that the shim touches the dura matter. It is noted that in FIGS. 6-7 and in FIGS 36-37, the scalp overlying the calvarial bone 2 is not shown for the sake of clarity of illustration. Turning to FIG. 6, an ICI 80 with a shim 100 attached thereto are shown implanted within a cylindrical recess 2B made in the calvarial bone 2 the ICI 80 has a lid 82 that may be sealingly screwed to hermetically seal the housing 84 of the ICI 80. The ICI 80 has a first ICI-side 81A and a second ICI-side 8 IB. The ICI 80 includes an electronics module 86 electrically connected to several stimulating and sensing electrodes. It is noted that only two stimulating electrodes 80A and 80B are seen in the cross-sectional view of FIGS. 6-7, However, the ICI 80 may have other stimulating electrodes and sensing electrodes (not shown in the cross-sectional view of FIGS. 6 and 7).

[0190] The ICI 80 includes an annular current return electrode 80F that may be embedded in or attached to the housing 84. The ICI 80 also includes side-tabs 84A and 84B that protrude sideways from the housing 84 of the ICI 10. The side-tabs 84A and 84B have screw holes 84C and 84D, respectively formed therein. After inserting the ICI assembly including the ICI 80 and the shim 100 into the recess 2B, the ICI 80 may be firmly attached to the outer surface 2 A of the calvarial bone 2 by screwing two bone screws 85A and 85B into the calvarial bone 2 through the screw holes 34C and 34D, respectively. The current return electrode 80F may be operated as a current source or a current sink (depending on the polarity of the stimulating electrical currents) for the stimulating electrodes of the ICI 80. The shim body 102 may have several hollow passages formed therein. However, only two hollow passages 100A and 100B are seen in the cross-sectional view of FIG. 6. The shim body 102 has a first shim-side 102D attachable to the ICI 80 and a second shim-side 102B that may face the bottom surface 2C of the recess 2B after implantation.

[0191] When a stimulating current is passed between the stimulating electrodes (such as, for example, the electrodes 80A and 80B) and the current return electrode 80F, the currents may pass the remaining thickness M of the calvarial bone 2, the CSF layer 3 the dura matter 4 and the arachnoid matter 5 to reach the cerebral cortex 6.

[0192] The calvarial bone has a thickness N. The height of the cylindrical recess 2B is K and the thickness of the remaining layer of bone is M. The shim 100 is manufactured such that the thickness H of the shim 100 (which is also the effective thickness of the shim 100) combined with the standard thickness B of the ICI 80 equals the height K of the cylindrical recess 2B (H+B =K). Thus, the effective thickness H of the shim 100 is such that after implantation and attachment of the ICI 80 to the outer surface 2A of the calvarial bone 2, the second shim-side 102B of the shim 100 is in contact with or is in the vicinity of the bottom surface 2C of the recess 2B.

[0193] It is noted that the surface 82A of the lid 82 of the ICI 80 is not completely flush with the outer surface 2A of the calvarial bone 2 because of the thickness of the side-tabs 84A and 84B. The ICI 80 may have a standard (or standardized) effective thickness B. In the implantation embodiment illustrated in Fig. 6 in which the assembly including the ICI 80 and the shim 100 attached thereto is implanted in a recess 2B made in the calvarial bone 2 (without breaching the calvarial bone 2), the ability to adapt the thickness H of the shim 100 such that H+B=K, solves the problem of the variability of the thickness of the calvarial bone 2 in different patients and in different locations on the skull.

[0194] It is noted that while the method of implanting the ICI and the shim within a recess formed in the calvarial bone 2 (such as, for example, the recess 2B) has the advantage of not breaching the calvarial bone 2, resulting in minimizing the possibility of post-operation infection of brain tissues, the method is not obligatory, and in some embodiments the implantation of the assembly of the ICI and the shim may involve full penetration of the calvarial bone 2 and insertion of the ICVShim assembly through an opening made in the calvarial bone 2.

[0195] Turning to FIG. 7, the ICI 80 is the same ICI illustrated in FIG. 6. However, the shim 120 may be different than the shim 100 of FIG. 6. It is noted that the effective thickness of the shim 120 is labeled H for designation purposes, even though the actual value of the effective thickness H of FIG. 6 may be larger than or smaller than the effective thickness H of the shim 100 of FIG. 7, depending, inter alia on the exact thickness of the calvarial bone 2 (which may vary in the range of 1-25 millimeter) at the site of implantation and on the distance between the inner surface 2C of the calvarial bone and the selected target tissue (which may be the outer surface 4 A of the matter 4 or a portion of the arachnoid matter 5 or the outer surface of the pia matter (not shown in FIG. 37), or the surface of the cortex 6.

[0196] The shim 120 includes a shim body 122 having a first shim- side 121 A attachable to the first ICI-side 81A and a second shim-side 121B opposing the first shim-side 121A. The sim body 122 has multiple hollow passages formed therein. It is noted that only two hollow passages 122A and 122B may be seen in the cross-sectional view of FIG. 7. The hollow passage 122A has a first opening 122G on the first surface 122D of the shim body 122 and a second opening 122H on the second shim-side 122C of the shim body 122. The hollow passage 122B has a first opening 122E on the first surface 122D of the shim body 122 and a second opening 122F on the second side 122C of the shim body 122. When the ICI 80 and the shim 120 are assembled, the shim 120 is aligned such that the first openings 122G and 122E of the hollow passages 122A and 122B are opposite the electrodes 8 A and 80B, respectively.

[0197] During the implantation of the assembly including the ICI 80 and the shim 120, a through hole 2F is formed (for example, by drilling) that passes through the entire thickness N of the calvarial bone 2. The assembly of the ICI 80 and the shim 120 attached thereto is inserted through the hole 2E and the side-tabs 84A and 84B are attached to the outer surface 2A of the calvarial bone 2 by screwing the screws 85A and 85B through the holes 84C and 84D, respectively into the calvarial bone 2). The assembled ICI 80 and shim 120 extends through the CSF 3 and the second side 122C of the shim body 122 may touch or may be positioned in the vicinity of the surface 4A of the dura matter layer 4 overlying the cortex 6. It is noted that the thin pia matter layer attached to the cortex 6 is not shown in FIGS. 6-7.

[0198] When the shim 120 is designed for a specific patient and skull location, the thickness H is made such that H=L - B, where L is the distance between the surface 4 A of the dura matter 4 and the outer surface 2A of the calvarial bone 2, and B is the standard effective thickness of the ICI 80. This ensures that when the ICI 80 is attached to the outer surface 2A of the calvarial bone 2, the second surface 122C of the shim body 122 touches or is positioned in the vicinity of the surface 4 A of the dura matter 4.

[0199] The value of L may be determined by one or more imaging methods performed for each specific patient, such as, for example, MRI, fMRI, CT, or combinations of such methods, as disclosed in detail hereinabove. Since the effective thickness B of the standard ICI 80 is known, after L is determined, the desired effective thickness H of the shim 120 may be then calculated as H=L-B. Thus, the shim 120 may be individually adapted (and made) for each specific patient, taking into account the specific implantation site on the skull of the patient, solving the problem of the individual differences in individual patients and different implantation sites.

[0200] It will be appreciated by those skilled in the art that in some embodiments, it may also be possible to remove part of the layer dura matter 4 and the arachnoid matter 5 to expose the thin pia matter layer (not shown due to its thinness) overlying the cortex 6. In such cases the effective thickness H of the shim will be equal to the distance between the surface 2 A and the surface of the pia matter attached to the cortex minus the effective thickness B of the ICI 80.

[0201] It is noted that while the passages formed in the shims 20, 100 and 120 described hereinabove are hollow passages, this is not obligatory. Typically, the hollow passages within the shims 20, 100 and 120 may become filled with a liquid after implantation. If the implantation is as illustrated in FIG. 6, the fluid may be a fluid contained in the cancellous bone layer (not shown) of the calvarial bone 2. If the implantation is as illustrated in FIG. 7, the fluid may be the CSF 3. In either case, as the fluid filling the hollow passages (such as, for example, the hollow passages 40A-40E and 45A-45D of the shim 20, the passages 100A-100B of the shim 100 and the passages 122A and 122B of the shim 120) is electrically conducting, they allow current to flow within the fluid filled passages and stimulated the cortex 6. It is noted that the drawing figures of the present application are not drawn to scale and are schematic drawings provided for assisting the understanding the structural details of the shims of the present application. Thus, in some of the drawing figures, the thicknesses H, and B may not be drawn to scale. However, typically, the standardized ICI effective thickness B may be within the range of 1-10 millimeter. The thickness H (of FIG. 6) may vary within the range of 1-10 millimeter (depending, inter alia, on the value of B and the depth K of the recess 2B). The thickness H (of FIG. 7) may vary within the range of 2- 10 millimeter (depending, inter alia, on the value of B and the distance L).

[0202] The human skull can be as thin as 1 mm (at the temporal squamous bone) to as thick as 25 mm in some people. On the average skull thickness is between 6- 12mm. A paper entitled “Morphometric Measurement of Cranial Vault Thickness: A Tertiary Hospital Based Study” by Suraj Thulung, Kajan Ranabhat, Suresh Bishokarma, and Dinesh Nath Gongal, published in JNMA Nepal Med Assoc. 57 / 215 pp.29-32 (28 Feb. 2019), doi: 10.31729 / jnma.3949, describes skull thickness data across age and gender.

[0203] Furthermore, with respect to the type of implantation illustrated in FIG. 7, it will be appreciated that some variations in the surgical procedures are possible. For example, if a part of the dura matter 4 and / or the arachnoid matter 5 overlying the cortical stimulation target region are removed to expose the pia matter (not shown) covering the cortex 6, then, the distance X between the pia matter and the outer surface 2A of the calvarial bone 2 should be determined instead of the distance L of Fig. 7, and should be used in the calculation of the effective thickness H of the shim such that H=X-B.

[0204] It is noted that the use of hollow passages within the shim is not obligatory and that, if the passages are filled with an electrically conducting material, they may conduct electrical currents even though the passages are not hollow.

[0205] Reference is now made to FIGS 8-9 which are schematic cross-sectional diagrams illustrating two different embodiments of shims having passages filled with electrically conducting materials and ICIs attachable to the shims.

[0206] Turning to FIG. 8, the shim 140 has a shim body 142 that may be made from any of the electrically non-conducting material disclosed hereinabove with respect to the shim body 20 of FIG. 3. The shim 140 has a first shim-side 141A and a second shim-side 141B opposing the first shim-side 141 A. The passages 142A and 142B seen in the cross-sectional view of the shim 140 may be filled with solid members 145 and 146, respectively. The solid members 145 and 146 may be made from an electrically conducting material such as, for example, a metal, a metallic alloy and an electrically conducting polymer. When the shim 140 is attached to the ICI 80 (using a suitable adhesive or any other attachment method described hereinafter), the surfaces 145A and 145B of the solid members 145 and 146, contact the electrodes 80A and 80B, respectively. When an electrical voltage difference is applied between the electrodes 8OA-8OB and the current return electrode 80F, an electrical current may flow through the members 145 and 146, respectively and may reach the cortex 6. Practically, the surfaces 145C and 146D may thus effectively act as a current source or current sink (depending on the polarity of the voltage difference between the electrodes 8OA-8OB and the current return electrode 80F).

[0207] Examples of metals that may be used to implement the solids members 145 and 146 are gold and platinum, but other suitable metals may also be used. Alloys may include, various different ratios of gold, platinum, titanium and other suitable metals. The solid members 145 and 146 may also be made from a less expensive metal having high electrical conductivity (such as, for example, copper or silver) that are coated or plated or electroplated with a layer of a more biocompatible metal or alloy such as gold or platinum. This has the advantage of being less expensive while maintaining biocompatibility. Some methods for manufacturing shims with passages including electrically conducting solid members are be described hereinafter.

[0208] In some embodiments of the shims of the present application, the solid members 145 and 146 may be made from an electrically conducting polymer, such as, for example, a PEDOT based polymer, a polypyrrole-based polymer, a poly-aniline based polymer, a PEDOP based polymer, co-polymers of the above indicated polymers, or any other suitable biocompatible electrically conducting polymer or copolymer.

[0209] It is noted that the filling material of the filled passages of the shims of the present application are not limited to solid materials. In some embodiments of the shims, the electrically conducting material filling the passages may be a semi-solid or gel-like electrically conducting material.

[0210] Turning to FIG. 9, the shim 150 has a shim body 152 that may be made from any of the electrically non-conducting material disclosed hereinabove with respect to the shim body 20 of FIG. 3. . The shim 150 has a first shim-side 151A and a second shim-side 151B opposing the first shim-side 141A. The passages 152A and 152B seen in the cross-sectional view of the shim 150 may be filled with a semi-solid (or gel-like) electrically conducting material 155, such as, for example, cross-linked acrylamide-based hydrogels including gold nanoparticles. When the shim 150 is attached to the ICI 80 (using a suitable adhesive or any other attachment mechanism described hereinafter), the surfaces 155A and 155B of the electrically conducting material 155 contact the electrodes 80A and 80B, respectively. When an electrical voltage difference is applied between the electrodes 8OA-8OB and the current return electrode 80F, an electrical current may flow through the semi-solid material 155 disposed within the passages 152A and 152B and may reach the cortex 6. Practically, the surfaces 155C and 155D may thus effectively act as a current source or current sink (depending on the polarity of the voltage difference between the electrodes 8OA-8OB and the electrode 80F).

[0211] It is noted that the chemistry of the semi-solid electrically conducting biocompatible materials and hydrogels and methods of their synthesis and preparation is not the subject matter of the present application, is known in the art and is therefore not described in detail hereinafter. Briefly, examples of materials that may be used to implement the electrically conducting semisolids or gel-like materials 155 are cross-linked hydrogel matrices (including, for example, crosslinked acrylamide or acrylamide derivative based polymer or co-polymer matrices including electrically conducting nanoparticles or ionic solutions (such as, for example, gold nanoparticle, platinum nanoparticles, carbon nanotubes, graphene nanoparticles, PEDOT:PSS nanoparticles, or any other suitable electrically conducting biocompatible nanoparticles). Other examples may include soft hydrogels such as the D-sorbitol-PEDOT:PSS based hydrogel disclosed by Hao He et al. in an article titled “Biocompatible Conductive Polymers with High Conductivity and High Stretchability” published in ACS Appl. Mater. Interfaces, 2019, 11, 29, 26185-26193.

[0212] Other examples may be any of the biocompatible electrically conducting hydrogels disclosed in an article by Anthony Guiseppi-Elie entitled “Electroconductive hydrogels: Synthesis, characterization and biomedical applications” published in Biomaterials 31 (2010) 2701-2716, and in an article by Richard Balint et al. entitled “Conductive polymers: Towards a smart biomaterial for tissue engineering” published in Acta Biomaterialia 10 (2014) 2341-2353. All the above three articles are incorporated herein by reference in their entirety.

[0213] Such biocompatible electrically conducting hydrogels may be based on poly (2- Hydroxyethyl methacrylate) hydrogels including co-polymerized and / or crosslinked electrically conducting polymers.

[0214] It is noted that when the electrically conductive semi- solid material 155 is a hydrogel, the electrical conductivity of the gel may be achieved by polymerizing and / or cross linking the monomer or the monomers (in case one uses more than one monomer to produce a gel formed from a co-polymer) in a suitable electrically conducting solution such as, for example, a phosphate buffered saline (PBS) isotonic solution, or any other biocompatible solution containing electrolytes that has sufficient ionic conductivity and has similar isotonicity and osmolarity to the liquid bathing the implantation site (such as, for example, CSF). Such an electrically conducting solution may be a sterilized solution.

[0215] The use of the shims having passages that are filled with solid or semi-solid electrically conducting materials may have the advantage that the shims are replaceable. One common problem with implants is the gradual deposition of biological materials such as, scar tissue, protein films and / or other biological deposits on the surface of the implant. Such deposits on the surface of electrodes may gradually change (usually increase) their electrical resistance which may change or diminish the stimulation efficacy over time. When this happens, the voltage applied to such stimulating electrodes may need to be increased to achieve the same stimulating effects which may result in higher energy consumption. The shims described in FIGS. 8-9 may enable to periodically remove the ICI and shim assembly from the implantation site removing the shim from the ICI and replacing it with a fresh shim without having to clean the electrodes of the ICI. The use of such replaceable shims may assist in making the expensive ICI reusable.

[0216] Another advantage of all the shims of the present application is that they may be changed when needed to account for gradual changes of the cortical target areas in need of stimulating. It may happen that the anatomical site and neuronal activity distribution of the relevant neuronal functional networks (such as, for example, the position or the distribution of task activated DAN or FPN may exhibit long term changes or shifts in individual patients.

[0217] A paper entitled “Resting- state functional MRI in depression unmasks increased connectivity between networks via the dorsal nexus” by Yvette I. Sheline, Joseph L. Price, Zhizi Yan, and Mark A., published in PNAS Vol. 107 No. 24 (June 15, 2010), www(dot)doi(dot)org / 10(dot)1073 / pnas.1000446107, describes changes in network connectivity in depressed patients vs. a control group.

[0218] A paper entitled “Is There “One” DLPFC in Cognitive Action Control? Evidence for Heterogeneity From Co- Activation-Based Parcellation” by Edna C. Cieslik, Karl Zilles, Svenja Caspers, Christian Roski, Tanja S. Kellermann, Oliver Jakobs, Robert Langner, Angela R. Laird, Peter T. Fox and Simon B. Eickhoff, published in Cerebral Cortex November 2013;23:2677-2689, (www(dot)doi: 10(dot)1093 / cercor / bhs256), provides high resolution fMRI maps of the DLPFC during its participating and recruitment into the DAN.

[0219] Therefore, it might be necessary to change or modify the stimulation target areas to account for such shifts. Such changes may be monitored by performing task related fMRI or by long-term analysis of the cortical electrical signals recorded by the sensing electrodes of the ICI (such as, for example, by the sensing electrodes 25A-25D of the ICI 10 of FIG. 1). If such detected changes require changing the current density distribution reaching the cortical region underlying the ICI, it may be possible to remove the ICI from the implantation sited, remove the shim attached to the IC and replace it with a new shim with a different passage configuration designed to achieve the desired current density distribution The assembled ICI and shim may then be implanted again in the same recess or implantation channel. This is advantageous as it allows to use a less expensive shim instead of replacing the significantly more costly ICI.

[0220] Another advantage of the shims disclosed in the present application is that when combined with ICIs that have multiple stimulating electrodes that are arranged in a fixed configuration, the shims may allow to modify the stimulating current density distribution under the ICI to accommodate individual differences in the number and distribution of cortical stimulation target of different patients without having to modify the ICI itself.

[0221] Reference is now made to FIGS. 10 and 11. FIG. 10 is a schematic bottom view illustrating an ICI having an array of stimulating electrodes. FIG. 11 is a schematic cross-sectional view of the ICI of FIG. 10 taken along the lines XI-XI.

[0222] The ICI 60 is similar to the ICI 10 of FIGS 1-2, except the instead of the electrodes 30A- 30D, 30E and 25A-25D of the ICI 10, the ICI 60 includes a square array of stimulating electrodes 62A-62I and four sensing electrodes 65A-65D, arranged on a surface 64E of a first ICI-side 61 A as seen in FIG. 10. The ICI 60 also has a second ICI-side 6 IB opposing the first ICI-side 61 A. An annular current return electrode 64F is similar in structure and function to the current return electrode 30F of the ICI 10. A threaded lid 70 hermetically closes the housing 74 using a female threaded portion 74A. Two side-tabs 76A and 76B are formed as an integral part of the lid 70 and have screw holes 74C and 74D, respectively, formed therein and may be used to attach the ICI 60 to the calvarial bone of a patient as disclosed in detail hereinabove for the side-tabs 34A and 34B of the IDI 10 of FIG. 1. An electronics module 72 is hermetically sealed within the housing 74 and is electrically connected to the sensing electrodes 65A-65D, the stimulating electrodes 62A-62I and the current return electrode 64F. The electronics module 72 may include all the electronic and electrical circuits necessary for sensing cortical electrical signals from the brain of a patient, for delivering stimulating electrical signals to the cortex by applying suitable voltages between one or more of the stimulating electrodes 62A-62I and the current return electrodes, for harvesting energy from an external energizing unit (not shown), for controlling the operation of the ICI 60 for storing and processing data recorded by the sensing electrodes 65A-65D. The electronics module 72 may also include suitable communication circuits for wirelessly and bidirectionally communicating with external devices having wireless communicating capabilities.

[0223] It is noted that the construction and operation of ICIs such as the ICIs described in the present application is not the subject matter of the present application, and is therefore not described in detail in the present application. Detailed description of examples of such ICIs and their methods of their operation may be found, inter alia, in Published international applications WO2019 / 130248, WO2019 / 244099, W02020 / 050527, WO2020 / 161555, WO2021 / 144730 and

[0224] WG2018 / 109715.

[0225] As the ICI 60 may be a standard ICI, commonly used in various different patients, and as different patients may have different target cortical regions that may need to be electrically stimulated, the problem of the differences in stimulation targets in different individual patient may be solved by adapting the number, shape and configuration of the passages in the shims of the present application in accordance with the number, size and position of the stimulation targets of each individual patient. The effective (standardized) thickness B of the ICI 60 is illustrated in FIG. 11 and does not include the thickness ST of the side-tabs 64A and 64B (best seen in FIG. 10).

[0226] Reference is now made to FIGS. 12-17, which are schematic cross-sectional diagrams, each illustrating the ICI of FIG. 11 and a compatible shim attachable to the ICI and having multiple, differently shaped hollow passages, in accordance with some embodiments of the shims of the present application.

[0227] Turning to FIG. 12, the shim 200 has a shim body 222. The shim 200 has a first shim-side 201A attachable to the first ICI-side 61A and a second shim-side 201B opposing the first shimside 201 A. The shim body 222 has multiple passages formed therein. For example, the hollow passages 225 and 226 may be seen in the cross-sectional view of FIG. 12. The hollow passage 225 has two openings 225 A and 225B. The hollow passage 226 has two openings 226A and 226B. . The openings 226B and 225B open on a first surface 222D of the first shim-side 201A The openings 225A and 226A open on a second surface 222C of the second shim-side 201B. The cross- sectional area of the opening 225B is larger than the cross-sectional area of the opening 225A. The cross-sectional area of the second opening 226B is smaller than the cross-sectional area of the first opening 226A.

[0228] When the first shim-side 201A of the shim body 222 .is attached (by a suitable adhesive, or by any of the attachment methods disclosed in the present application) to the surface 64E of the first ICI-side 61 A , the opening 225B circumscribes the two stimulating electrodes 62D and 62E and the opening 226B circumscribes the electrode 62F. After implantation of the assembly including the ICI 60 and the shim 200 attached thereto, the hollow passages 225 and 226 are filled with an electrically conducting liquid (such as CSF or a liquid present in the cancellous layer of the calvarial bone). When a voltage difference is applied between the electrodes 62D and 62E and the current return electrode 64F, the current flowing from both of the electrodes 62D and 62E towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage 225 and exits through the opening 225A to stimulate the region of the cortex (not shown) underlying the opening 225A. Similarly, when a voltage difference is applied between the electrode 62F and the current return electrode 64F, the current flowing from the electrode 62F towards the current return electrode 64F passes through the electrically conducting fluid filling hollow passage 226 and exits through the opening 226A to stimulate the cortex (not shown) underlying the opening 226A. It is noted that the shape of the openings 225 A, 225B, 226A and 226B and may be circular or ellipsoidal or rectangular or any other desired shape including irregular shapes.

[0229] Turning to FIG. 13, the shim 230 has a shim body 232 having a first shim-side 231 A attachable to the first ICI-side and a second shim-side 23 IB opposing the first shim-side 231 A. The shim body 232 has multiple passages formed therein. For example, the hollow passages 235 and 236 may be seen in the cross-sectional view of FIG. 13. The hollow passage 235 has two openings 235A and 235B. The openings 236B and 235B open on a first surface 232D of the first shim-side 231 A The openings 235A and 236A open on a second surface 232B of the second shimside 23 IB. The cross-sectional area of the opening 235B is larger than the cross-sectional area, respectively of the opening 235A. The hollow passage 236 has two openings 236A and 236B opening on a second side 232C and a first side 232D, respectively, of the shim 230. The cross- sectional area of the opening 236B is smaller than the cross-sectional area of the opening 236A.

[0230] When the first surface 232D of the shim body 232 is attached (by a suitable adhesive, or by any of the attachment methods disclosed in the present application) to the surface 64E of the ICI 60, the opening 235B circumscribes the two stimulating electrodes 62D and 62E and the opening 236B circumscribes the electrode 62F. After implantation of the assembly including the ICI 60 and the shim 230 attached thereto, the hollow passages 235 and 236 are filled with an electrically conducting liquid (such as CSF or a liquid present in the cancellous layer of the calvarial bone). When a voltage difference is applied between the electrodes 62D and 62E and the current return electrode 64F, the current flowing from both of the electrodes 62D and 62E towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage 235 and exits through the opening 235A to stimulate the region of the cortex (not shown) underlying the opening 235A. Similarly, when a voltage difference is applied between the electrode 62F and the current return electrode 64F, the current flowing from the electrode 62F towards the current return electrode 64F passes through the electrically conducting fluid filling hollow passage 236 and exits through the opening 236 A to stimulate the cortical region (not shown) underlying the opening 236A, It is noted that the shape of the openings 235A, 235B, 236A and 236B may be circular or ellipsoidal or rectangular or any other desired shape including irregular shapes. Turning to FIG. 14, the shim 240 has a shim body 242 having a first shim-side 241 A attachable to the first ICI-side 61 A and a second shim-side 24 IB opposing the first shim-side 241 A. The shim body 242 has multiple passages formed therein. For example, the hollow passages

[0231] 245 and 246 may be seen in the cross-sectional view of FIG. 14. The hollow passage 245 has two openings 245A and 245B, and the hollow passage 246 has two openings 246A and 246B. The hollow passage 245 has a tapering shape narrowing towards a second surface 242C of the second shim-side 24 IB shim body 242. The cross-sectional area of the opening 245B is larger than the cross-sectional area, of the opening 245A. The hollow passage 246 has a tapering shape narrowing towards a first surface 242D of the first shim-side 241 A of the shim body 240. The hollow passage

[0232] 246 has two openings 246A and 246B opening on a second surface 242C of the second shim-side 24 IB of the shim 240. The cross-sectional area of the opening 246B is smaller than the cross- sectional area of the opening 246A.

[0233] When the first surface 242D of the first shim-side 241 A shim body 242 is attached (by a suitable adhesive, or by any of the attachment methods disclosed in the present application) to the surface 64E of the ICI 60, the opening 245B circumscribes the two stimulating electrodes 62D and 62E and the opening 246B circumscribes the electrode 62F. After implantation of the assembly including the ICI 60 and the shim 240 attached thereto, the hollow passages 245 and 246 are filled with an electrically conducting liquid (such as CSF or a liquid present in the cancellous layer of the calvarial bone). When a voltage difference is applied between the electrodes 62D and 62E and the current return electrode 64F, the current flowing from both of the electrodes 62D and 62E towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage 245 and exits through the opening 245A to stimulate the region of the cortex (not shown) underlying the opening 245A. Similarly, when a voltage difference is applied between the electrode 62F and the current return electrode 64F, the current flowing from the electrode 62F towards the current return electrode 64F passes through the electrically conducting fluid filling hollow passage 246 and exits through the opening 246 A to stimulate the cortical region (not shown) underlying the opening 246A. It is noted that the shape of the openings 245 A, 245B, 246A and 246B and may be circular or ellipsoidal or rectangular or any other desired shape including irregular shapes.

[0234] Turning to FIG. 15, the shim 250 has a shim body 252 having a first shim-side 251 A and a second shim-side 25 IB opposing the first shim-side 251 A. The shim body 252 has multiple passages formed therein. For example, the hollow passages 255 and 256 may be seen in the cross- sectional view of FIG. 15. The hollow passage 255 is a branching passage that has a single opening 255B on a first surface 252D of the first shim-side 251 A of the shim body 252 and two openings 255A and 255C that open on a second surface 252C of the second shim side 25 IB of the shim body 252. The cross-sectional area of the opening 255B is larger than the cross-sectional area of the opening 255A and is also larger than the cross-sectional area of the opening 255C. However, it is noted that in some embodiments, the cross-sectional area of the opening 255B maybe smaller than the cross-sectional areas of either one or both of the openings 255A and 255C. In some embodiments, the cross-sectional area of the opening 255A may be smaller than the cross-sectional area of the opening 255A but larger than the cross-sectional area of the opening 255C. In some other embodiments, the cross-sectional area of the opening 255A may be smaller than the cross- sectional area of the opening 255C but larger than the cross-sectional area of the opening 255A. In some embodiments, the cross-sectional area of the opening 255A may be larger than the cross- sectional area of the opening 255C and in some other embodiments, the cross-sectional area of the opening 255B may be larger than the cross-sectional area of the opening 255A. In some embodiments, the cross-sectional area of the opening 255B may be equal to the cross-sectional area of the opening 255A. In some embodiments, the shape of the openings 255A and 255C may be identical. In some embodiments, the shape of the openings 255A and 255C may be different.

[0235] The hollow passage 256 is a branching (bifurcating) passage that has a single opening 255A on the second surface 252C of the second shim-side 25 IB of the shim body 252 and two openings 256B and 256C opening on the first surface 252D of the first shim-side 251 A of the shim body 252. The cross-sectional area of the opening 255A is smaller than the cross-sectional area of the opening 255B and is also smaller than the cross-sectional area of the opening 255C. The cross- sectional area of the opening 255B is equal to the cross-sectional area of the opening 255C. However, it is noted that in some embodiments, the cross-sectional area of the opening 255A may be larger than the cross-sectional areas of either one or both of the openings 255B and 255C. In some embodiments, the cross-sectional area of the opening 255B may be smaller than the cross- sectional area of the opening 255A but larger than the cross-sectional area of the opening 255C. In some other embodiments, the cross-sectional area of the opening 255B may be smaller than the cross-sectional area of the opening 255C but larger than the cross-sectional area of the opening 255A. In some embodiments, the cross-sectional area of the opening 255B may be larger than the cross-sectional area of the opening 255C and in some other embodiments, the cross-sectional area of the opening 255B may be larger than the cross-sectional area of the opening 255A. In some embodiments, the cross-sectional area of the opening 255B may be equal to the cross-sectional area of the opening 255A. In some embodiments, the shape of the openings 255A and 255C may be identical. In some embodiments, the shape of the openings 255A and 255C may be different. It is noted that, any possible combinations and permutations of the cross-sectional areas and shapes of the openings 255A, 255B and 255C of the branching hollow passage 255 may be implemented in embodiments of the shim 250, and any possible combinations and permutations of the cross-sectional areas and shapes of the openings 256A, 256B and 256C of the branching hollow passage 256 may be implemented in embodiments of the shim 250.

[0236] When the first surface 252D of the shim body 252 is attached (by a suitable adhesive, or by any of the attachment methods disclosed in the present application) to the surface 64E of the ICI 60, the opening 255B circumscribes the stimulating electrode 62D and the opening 256B circumscribes the electrodes 62E and 62F. After implantation of the assembly including the ICI 60 and the shim 250 attached thereto, the hollow passages 255 and 256 are filled with an electrically conducting liquid (such as CSF or a liquid present in the cancellous layer of the calvarial bone). When a voltage difference is applied between the electrode 62D and the current return electrode 64F, the current flowing from the electrode 62D towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage 255 and exits through the openings 255A and 255C to stimulate the regions of the cortex (not shown) underlying the openings 255A and 255C.

[0237] Similarly, when a voltage difference is applied between the electrodes 62E and 62F and the current return electrode 64F, the current flowing from the electrodes 62E and 62F towards the current return electrode 64F passes through the electrically conducting fluid filling hollow passage 256 and exits through the opening 256 A to stimulate the cortical region (not shown) underlying the opening 256A. It is noted that the shape of the openings 255A, 255B, 255C, 256A, 256B and 256C may be circular or ellipsoidal or rectangular or any other desired shape including irregular shapes. In some embodiments, each one of the openings 255A, 255B, 255C, 256A, 256B and 256C of the shim body 252 may have a different shape. Any possible combinations permutations of the openings 255A, 255B, 255C, 256A, 256B and 256C may be implemented in some embodiments of the shim 250.

[0238] Turning to FIG. 16, the shim 260 has a shim body 262 having a first shim-side 261A and a second shim-side 26 IB opposing the first shim-side 261 A. The shim body 262 has multiple passages formed therein. For example, the hollow passages 265 and 266 and 267 may be seen in the cross-sectional view of FIG. 16. The hollow passage 265 is cylindrically shaped and has two circular openings 265 A and 265B opening on a second surface 262C of the second shim-side 26 IB and on the first surface 262D of the first shim-side 261 A, respectively, of the shim body 262. The hollow passage 266 is cylindrically shaped and has two circular openings 266A and 266B opening on the second surface 262C and the first surface 262D, respectively, of the shim body 262. The hollow passage 267 is cylindrically shaped and has two circular openings 267A and 267B opening on the second surface 262C and the first surface 262D, respectively, of the shim body 262.

[0239] When the first surface 262D of the shim body 262 is attached (by a suitable adhesive, or by any of the attachment methods disclosed in the present application) to the surface 64E of the ICI 60, the opening 265B circumscribes the electrode 62D, the opening 266B circumscribes the electrode 62E and the opening 267B circumscribes the electrode 62F. After implantation of the assembly including the ICI 60 and the shim 260 attached thereto, the hollow passages 265 and 266 and 267 are filled with an electrically conducting liquid (such as CSF or a liquid present in the cancellous layer of the calvarial bone). When a voltage difference is applied between the electrode 62D and the current return electrode 64F, the current flowing from the electrode 62D towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage 265 and exits through the opening 265A to stimulate the region of the cortex (not shown) underlying the opening 265A. When a voltage difference is applied between the electrode 62E and the current return electrode 64F, the current flowing from the electrode 62E towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage

[0240] 266 and exits through the opening 266A to stimulate the region of the cortex (not shown) underlying the opening 266A. When a voltage difference is applied between the electrode 62F and the current return electrode 64F, the current flowing from the electrode 62F towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage

[0241] 267 and exits through the opening 267 A to stimulate the region of the cortex (not shown) underlying the opening 267A. The cross-sectional areas of the openings 265A, 265B, 266A, 266B, 267 A and 267B are identical.

[0242] Turning to FIG. 17, the shim 270 has a shim body 272 having a first shim-side 271 A and a second shim-side 27 IB opposing the first shim-side 271 A. The shim body 272 has multiple passages formed therein. For example, the hollow passages 275 and 276 may be seen in the cross- sectional view of FIG. 17. The hollow passage 275 has two openings 275A and 275B opening on a second surface 272C and a first surface 272D, respectively, of the shim body 272. The cross- sectional area of the opening 275B is larger than the cross-sectional area of the opening 275A. The hollow passage 276 is a non-symmetrical hollow passage that has two openings 276A and 276B opening on the second surface 272C and on the first surface 272D, respectively, of the shim body 272. The cross-sectional area of the opening 276A is smaller than the cross-sectional area of the opening 276 A.

[0243] When the first surface 272D of the shim body 272 is attached (by a suitable adhesive, or by any of the attachment methods disclosed in the present application) to the surface 64E of the ICI 60, the opening 275B circumscribes the two stimulating electrodes 62D and 62E and the opening 276B circumscribes the electrode 62F. After implantation of the assembly including the ICI 60 and the shim 270 attached thereto, the hollow passages 275 and 276 are filled with an electrically conducting liquid (such as CSF or a liquid present in the cancellous layer of the calvarial bone). When a voltage difference is applied between the electrodes 62D and 62E and the current return electrode 64F, the current flowing from both of the electrodes 62D and 62E towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage 275 and exits through the opening 275 A to stimulate the region of the cortex (not shown) underlying the opening 275 A. Similarly, when a voltage difference is applied between the electrode 62F and the current return electrode 64F, the current flowing from the electrode 62F towards the current return electrode 64F passes through the electrically conducting fluid filling hollow passage 276 and exits through the opening 276A to stimulate the cortex (not shown) underlying the opening 276A. It is noted that the shape of the openings 225 A, 275B, 276A and 276B and may be circular or ellipsoidal or rectangular or any other desired shape including irregular shapes. Furthermore, by using asymmetrical hollow passages like the hollow passage 276, it is possible to apply stimulating currents to cortical regions that do not lie directly under a particular stimulating electrode or under a particular stimulating electrode group.

[0244] Reference is now mage to FIGS.18-20. FIG. 18 is a schematic cross-sectional diagram illustrating the ICI of FIGS. 10 and 11 and a compatible shim attachable to the ICI and having multiple, differently shaped hollow passages, in accordance with some embodiments of the shims of the present application. FIG. 19 is a schematic top view illustrating a first side of the shim that is attachable to the ICI of FIGS.10-11. FIG. 20 is a schematic bottom view illustrating a second side of the shim of FIGS. 18 and 19.

[0245] Turning to FIG. 18, the shim 280 has a shim body 282 having a first shim-side 281 A and a second shim-side 28 IB opposing the first shim-side 281 A. The shim body 282 has multiple passages formed therein. For example, the hollow passages 285 and 286 may be seen in the cross- sectional view of FIG. 18. The hollow passage 285 is a branching passage that has a single square opening 285B on a first surface 282D of the first shim-side 281 A and two openings 285A and 285C opening on a second surface 252C of the second shim-side 28 IB. The opening 285A has an irregular shape and the opening 285C has a rectangular shape. The cross-sectional area of the opening 285B is larger than the cross-sectional area of the opening 285A and is also larger than the cross-sectional area of the opening 285C. The hollow passage 286 is a hollow passage having a first rectangular opening 286B on the first surface 282D of the shim body 282 and a second irregularly shaped opening 286A on the second surface 282C of the second shim-side 28 IB.

[0246] A third hollow passage 287 (not seen in the cross-sectional view of FIG. 18) of the shim body 282 has a first rectangular opening 287B on the first surface 282D of the first shim-side 281 A and a second circularly shaped opening 287A on the second surface 282C of the second shim side 281B.

[0247] Turning to FIGS. 19-20, the solid lines marked 285B, 286B and 287B illustrate the rectangular openings 285B, 286B and 287B of the hollow passage 285, 286 and 287, respectively of the shim 280. The dashed lines represent the positions of the stimulating electrodes 62A-62I of the ICI 60 (of FIGS. 10-11) when the ICI 60 is correctly radially aligned with respect to the shim 280 and the surface 64E of the first ICI-side 61 A is attached to the first surface 282D of the shim body 282. The shim 280 also includes four hollow cylindrical passages 289A, 289B, 289C and 289D. The cylindrical hollow passages 289A, 289B, 289C and 289D have circular openings 291 A, 29 IB, 291C and 29 ID, respectively, that open on the surface of the first side 282D of the shim body 282. The cylindrical passages 289A, 289B, 289C and 289D also have circular openings 290A, 290B, 290C and 290D, respectively that open on the surface of the second side 282C of the shim body 282. In FIG. 20, the dashed lines 285B, 286B and 287B represent the position of the openings 285B, 286B and 287B on the first surface 282D of the shim body 282. It is noted that the hollow passages 289A, 289B, 289C and 289D do not appear in the cross-sectional view of the shims illustrated FIGS.12-18 because the plane of the cross section in these drawing figures does not pass through any of these openings.

[0248] When the first side 282D of the shim body 282 is attached (by a suitable adhesive, or by any of the attachment methods disclosed in the present application) to the surface 64E of the first ICI-side 61 A, the opening 285B circumscribes the stimulating electrodes 62F, 62E, 62H and 621, the opening 286B circumscribes the stimulating electrodes 62A, 62D and 62G, the opening 287B circumscribes the stimulating electrodes 62B and 62C and the openings 291A, 291B, 291C and 291D circumscribe the sensing electrodes 65A, 65B, 65C and 65D, respectively.

[0249] After implantation of the assembly including the ICI 60 and the shim 280 attached thereto, the hollow passages 255 and 286 are filled with an electrically conducting liquid (such as CSF or a liquid present in the cancellous layer of the calvarial bone). When a voltage difference is applied between the electrodes 62F, 62E, 62H, 621 and the current return electrode 64F, the current flowing from the stimulating electrodes 62F, 62E, 62H and 621 towards the current return electrode 64F passes through the electrically conducting liquid filling the hollow passage 285 and exits through the openings 285A and 285C to stimulate the regions of the cortex (not shown) underlying the openings 285A and 285C. When a voltage difference is applied between the electrodes 62A, 62D, 62G and the current return electrode 64F, the current flowing from the electrodes 62A, 62D, 62G towards the current return electrode 64F passes through the electrically conducting fluid filling hollow passage 286 and exits through the opening 286A to stimulate the cortical region (not shown) underlying the opening 286A. When a voltage difference is applied between the electrodes 62B and 62C and the current return electrode 64F, the current flowing from the electrodes 62B and 62C towards the current return electrode 64F passes through the electrically conducting fluid filling hollow passage 287 and exits through the opening 287A to stimulate the cortical region (not shown) underlying the opening 287A.

[0250] The hollow passages 289A, 289B, 289C, and 289D that are filled with the electrically conducting liquid allow the sensing electrodes 65 A, 65B, 65C and 65D, respectively, to sense electrical signals from the cortex regions underlying the openings 291 A, 29 IB, 291C and 292D, respectively.

[0251] It is noted that while the openings 285B, 286B, 287B, 291A, 291B, 291C and 291D of the shim 280 have the specific shapes illustrated in FIG.19, this is by no means obligatory and any one of these openings may have any other desired shape, such as, for example, circular shapes, square shapes, rectangular shapes, other polygonal shapes, ellipsoidal shapes or irregular shapes. Similarly, the openings 285A, 285C, 286A, 287A, 290A, 290B, 290C and 290D may have any desired shape. Preferably but not obligatorily, the openings 290A, 290B, 290C and 290D may all have the same shape.

[0252] It is noted that for each hollow passage implemented in the shims of the present application, the shape and cross-sectional area of the opening(s) circumscribing stimulating electrode(s) the number of stimulating electrodes circumscribed by the opening of the hollow passage facing the stimulating electrode(s) and the shape and cross-sectional area of the opening(s) of that hollow passage opening on the second side of the shim may depend inter alia, on one or more of the following: the desired current density exiting the hollow passage, the shape and / or size of the target cortical area to be stimulated.

[0253] For example, the higher the desired current density exiting the one or more branches of a hollow passage, the higher the number of stimulating electrodes circumscribed by the opening(s) of that hollow passage on the side of the shim body facing the stimulating electrodes.

[0254] Therefore, another advantage of the shims of the present application is the ability to flexibly control the current density exiting any of the hollow passages to stimulate the cortex and to locally direct the currents to desired cortical targets in each individual patient without having to modify the ICI for each individual patient.

[0255] Moreover, the ability to use a single standard type of ICI and to manufacture a shim individually tailored to the needs of each individual patient may significantly reduce the cost and logistical requirements of manufacturing and may result in significant improvements in treatment efficacy as compared to implantation of a standard ICI without taking into account individual differences in cortical target(s) location.

[0256] It is noted that while the shims described hereinabove are attached to the ICI by using a suitable adhesive, this is not obligatory to practicing the invention and several other attachment methods may be used for attaching the shims of the present application to an ICI.

[0257] In accordance with some embodiments of the shims of the present application, the shims may have an attachment mechanism suitable for attaching the shim to an ICI,

[0258] Reference is now made to FIG. 21 which is a schematic cross-sectional view illustrating an assembly including an ICI and a shim, the shim having an attachment mechanism formed as a female threaded portion of the shim, in accordance with an embodiment of the shims of the present application.

[0259] The ICI and shim assembly 190 includes an ICI 180 a shim 300, a perforated sealing gasket 330. The ICI 180 has a first ICI-side 191 A and a second ICI-side 19 IB opposing the first ICI-side 191 A. The ICI 180 includes a housing 184 and a threaded lid 182 sealingly screwed into the housing 184. The housing 184 includes an electronics module 186 similar in construction and operation to the electronics module 86 of the ICI 80 of FIG. 6. The electronics module 186 is hermetically sealed within the housing 184. Two stimulating electrodes 180A and 180B disposed in or on the first ICI-side 191 A are suitably electrically connected to the electronics module 186. Any other stimulating electrodes and sensing electrodes of the ICI 180 are not seen in the cross- sectional view of FIG. 21. The ICI 180 also includes an annular current return electrode 180F similar to the current return electrode 80F of Fig. 6, The ICI 180 has two side-tabs similar to the side-tabs 84A and 84B of FIG. 6 that are not seen in the cross-sectional view of FIG. 21. The ICI 180 has a male threaded protruding portion 180C having a diameter smaller than the diameter of the housing 184.

[0260] The shim 300 has a first shim-side 301A and a second shim-side 301B opposing the first shim-side 301A. The shim 300 includes a shim body 302 that has an attachment mechanism 303 that may be used to attach the shim 300 to the ICI 180 to form the assembly 190. The attachment mechanism 303 is a cylindrically shaped female threaded recess 302A formed in the first shim side 301A of the shim body 302. The shim 300 may have multiple hollow passages passing therethrough. For example, the hollow passages 315 and 316 may be seen in the cross-sectional view of FIG. 21 (any other hollow passages included in the shim 300 are not shown in the cross- sectional view of FIG. 21). The hollow passage 315 has a first opening 315B opening on a first surface 302D of the first shim-side 301 A of the shim body 302 and a second opening 315A opening on a second surface 302C of the second shim-side 301B of the shim body 302. The hollow passage 316 has a first opening 316B opening on the first surface 302D of the first shim-side 301 A and a second opening 316A opening on the second surface 302C of the second shim-side 301B of the shim body 302. It is noted that while the hollow passages 315 and 316 are cylindrically shaped and the openings 315A, 315B, 316A and 316B are circular openings, in some embodiments the passages (such as, for example, the hollow passages 315 and 316) formed in the shim body 302 may have any desired shape and any desired cross section as disclosed hereinabove with respect to FIGS 1-20.

[0261] The shim 300 also includes a perforated sealing gasket 330. The perforated sealing gasket 330 may be made from any suitable, electrically non-conducting, elastic and / or flexible and / or compressible material. For example, the perforated sealing gasket 330 may be made from polybutadiene rubber, or from PDMS or from a polyether polyester co-polymer or from a crosslinked silicon rubber or from a thermoplastic polyurethane (TPU) based material. Preferably, but not obligatorily, the sealing gasket 330 is made from a biocompatible elastomer.

[0262] The perforated sealing gasket 330 has multiple perforations formed therein. For example, the perforations 33OA and 33OB may match in shape and size the openings 315B and 316B, respectively. The perforations circumscribing stimulating electrodes, such as, for example, the stimulating electrodes 180A and 180B allow currents to be passed through the openings 315B and 316B. Furthermore, the parts of the perforated sealing gasket 330 surrounding the perforations function to electrically isolate the stimulating electrodes from each other. For example, the electrically insulating material of the gasket 330 electrically isolate the stimulating electrode 180A from the stimulating electrode 180B (and from any other remaining stimulating electrode of the ICI 180). This isolation may be helpful in situations in which the current needs to flow between an electrode serving as a current source and another electrode serving as a current sink. For example, if a voltage of + 5Volt is applied to the electrode 180A and a voltage of -5Volt is applied to the electrode 180B the currents flowing from the electrode 180A to the electrode 180B is forced to flow through the electrically conducting liquid filling the hollow passage 315, exit from the opening 315A, pass through the cortical tissue underlying the shim 300, enter the opening 316A and flow through the electrically conducting liquid filling the hollow passage 316 into the stimulating electrode 180B. However, if the perforated sealing gasket 330 is not disposed between the shim 300 and the ICI 180, the electrically conducting fluid (such as, for example, CSF) may enter the space between the shim 300 and the ICI 180 (due to capillary action) and may allow current to pass between the electrodes 18A and 180B through the liquid filled space which may result in substantially reducing the current flowing through the cortical tissue leading to reducing the stimulation efficacy and wasting electrical power.

[0263] When the shim 300 and the ICI 180 are assembled together to form the assembly 190, the male threaded protruding portion 180C is screwed into the cylindrically shaped female threaded recess 302A to ensure a good sealing contact between the sealing gasket 330 and the opposing surfaces of the first ICI-side and the first shim-side 301A. Proper alignment of the perforations with the corresponding stimulating and sensing electrodes may be achieved by visually observing the electrodes through the openings 315A and 316A. However, in some embodiments, the shim 300 and the ICI 180 may have suitable alignment markers (not seen in the cross-sectional view of FIG. 21) such as the alignment markers 35 and 36 described in detail with respect to the ICI 10 and the shim 20 of FIGS. 4-5 hereinabove.

[0264] The effective (standardized) thickness B of the ICI 180 does not include the thickness ST of the side-tabs (not shown in the cross-sectional view of FIG. 21) included in the ICI 180 that may be used to attach the assembly 190 to the surface of the calvarial bone. Such side-tabs may be similar to the side-tabs 64A and 64B of the ICI 60.

[0265] It is noted that while in the shim 300 illustrated in FIG. 21, the shape of each of the perforations in the gasket 330 is identical to the shape of the corresponding hollow passage underlying the perforation, this is not mandatory, and in some embodiments of the shims of the present application, the perforations may not have a shape similar to the shape of the underlying opening of the corresponding hollow passage. For example, the perforation 33OA may have a shape and / or a cross-sectional area larger than the shape and / or cross-sectional area of the opening 315B. In another example the shape and / or the cross-sectional area of the perforation 33OB may be smaller than the shape and / or the cross-sectional area of the opening 316B.

[0266] In some embodiments, the gasket 330 may be attached to the first surface 301A of the shim body 302 by any suitable adhesive, such as, for example, any of the electrically non-conducting adhesives described with respect to attaching the ICI 10 to the shim 20 of FIGS 1-2.

[0267] It is noted that while the perforated sealing gasket 330 of FIG. 21 may be attached to the shim body 302 and forms a part of the shim 300, this is not obligatory. In some embodiments, the perforated sealing gasket 330 may be attached to the first ICI-side 191A of the ICI 180 by any of the adhesives described hereinabove. In some embodiments, the perforated sealing gasket 330 is not attached to the shim 300 or to the ICI 180 and is provided as a separate part to be placed between the shim 300 and the ICI 180 during the assembling of the assembly 190.

[0268] When the perforated sealing gasket is manufactured, the perforations may be made by any suitable method such as, for example, laser cutting and the sizes and shapes of the perforations are determined taking into account the sizes and shapes of the openings of the shim that is individually fabricated for an individual patient.

[0269] Reference is now made to FIG. 22 which is a schematic cross-sectional view illustrating an assembly including an ICI and a shim, the shim having an attachment mechanism formed as a male threaded portion of the shim, in accordance with an embodiment of the shims of the present application. The ICI and shim assembly 301 includes an ICI 310, a shim 340, and a perforated sealing gasket 350. The ICI 310 has a first ICI-side 311A and a second ICI side 31 IB opposing the first ICI-side 311A. The ICI 310 includes a housing 314 and a threaded lid 182 sealingly screwed into the housing 314. The housing 314 includes an electronics module 306 similar in construction and operation to the electronics module 86 of the ICI 80 of FIG. 6. The electronics module 306 is hermetically sealed within the housing 314. Two stimulating electrodes 310A and 310B are disposed in or on the first ICI-side and are suitably electrically connected to the electronics module 306. Any other stimulating electrodes and sensing electrodes of the ICI 310 are not seen in the cross-sectional view of FIG. 22. The ICI 310 also includes an annular current return electrode 310F similar to the current return electrode 80F of Fig. 6. The ICI 310 may have two side-tabs similar to the side-tabs 84A and 84B of FIG. 6, that are not seen in the cross-sectional view of FIG. 22. The first ICI-side 311 A of the ICI 310 has a female threaded cylindrically shaped recess 310D having a diameter smaller than the diameter of the housing 314. It is noted that the effective thickness of the ICI 310 is B which does not include the thickness ST of the side-tabs (not shown in the cross-sectional view of FIG. 22) included in the ICI 310 that may be used to attach the assembly 301 to the surface of the calvarial bone. Such side-tabs may be similar to the side-tabs 64A and 64B of the ICI 60.

[0270] The shim 340 has a first shim-side 341 A and a second shim-side 34 IB opposing the first shim-side 341 A. The shim 340 includes a shim body 342 that has an attachment mechanism 347 disposed on the first shim-side 341 A. The attachment mechanism 347 may be used to attach the shim 340 to the ICI 310 to form the assembly 301. The attachment mechanism 347 is a cylindrically shaped male threaded protruding portion 347 formed in the shim body 342. The shim 340 may have multiple hollow passages passing therethrough. For example, the hollow passages 320 and 321 may be seen in the cross-sectional view of FIG. 22 (any other hollow passages included in the shim 340 are not shown in the cross-sectional view of FIG. 21). The hollow passage 320 has a first opening 320B opening on a first surface 342D of the shim body 342 and a second opening 320A opening on a second surface 342C of the shim body 342. The hollow passage 321 has a first opening 32 IB opening on the first surface 342D of the shim body 342 and a second opening 321 A opening on the second surface 342C of the shim body 342. It is noted that while the hollow passages 320 and 321 are cylindrically shaped and the openings 320A, 320B, 321 A and 32 IB are circular openings, in some embodiments the passages (such as, for example, the hollow passages 320 and 321) formed in the shim body 342 may have any desired shape and any desired cross-section as disclosed hereinabove with respect to FIGS 1-20. The effective thickness of the shim 340 is HE as illustrated in FIG. 22 which does not include the thickness of the male threaded protruding portion 347. The thickness of the gasket 350 may be neglected when calculating the value of HE as the gasket can be made thin enough compared to the value of (B+HE).

[0271] The shim 340 may also include a perforated sealing gasket 350. In some embodiments, the perforated gasket 350 may be attached to the shim 340 by a suitable adhesive. In other embodiments, the perforated gasket 350 may be attached to the first ICI-side 311 A of the ICI 310 by a suitable adhesive. In some other embodiments the perforated gasket 350 may be separately provided and is not attached to neither the shim 340 nor to the ICI 310 and may be placed within the recess 310D before attaching the shim 340 to the ICI 310. In all three such embodiments, the thickness of the gasket 350 may be neglected when calculating the value of HE as the gasket can be made thin enough compared to the value of (B+HE).

[0272] The perforated sealing gasket 350 may be made from any suitable, electrically nonconducting, flexible and / or resilient material, as described in detail with respect to the perforated sealing gasket 330 of FIG. 21.

[0273] The perforated sealing gasket 350 has multiple perforations formed therein. For example, the perforations 350A and 350B may match in shape and size the openings 320B and 321B, respectively. The perforations circumscribing stimulating electrodes, such as, for example, the stimulating electrodes 310A and 310B allow currents to be passed through the openings 320B and 32 IB, respectively. Furthermore, the parts of the perforated sealing gasket 350 surrounding the perforations function to electrically isolate the stimulating electrodes from each other, as described in detail hereinabove with respect to the sealing gasket 330 of FIG. 21.

[0274] When the shim 340 and the ICI 310 are assembled together to form the assembly 301, the male threaded protruding portion 347 of the shim 340 is screwed into the cylindrically shaped female threaded recess 310D of the ICI 310 to ensure a good sealing contact between the sealing gasket 350 and the opposing surfaces of the ICI 310 and the shim 340. Proper alignment of the perforations with the corresponding stimulating and sensing electrodes may be achieved by visually observing the electrodes through the openings 320A and 321 A. However, in some embodiments, the shim 340 and the ICI 310 may have suitable alignment markers (not seen in the cross-sectional view of FIG. 22) similar to the alignment markers 35 and 36 described in detail with respect to the ICI 10 and the shim 20 of FIGS. 4-5 hereinabove.

[0275] It is noted that the attachment mechanisms of the shims of the present application are not limited to the attachment mechanisms illustrated in FIGS. 21-22. Rather, several other types of attachment mechanisms may be used in the shims of the present application.

[0276] Reference is now made to FIGS. 23-26. FIG. 23 is a schematic cross-sectional diagram illustrating a shim including a keyed bayonet type attachment mechanism including two side-pins, in accordance with an embodiment of the shims of the present application. FIG. 24 is a bottom view of an ICI including two locking slots compatible for receiving the side-pins of the shim of FIG. 23. FIG. 25 is a schematic cross-sectional view of the ICI of FIG. 24, taken along the lines XXV-XXV. FIG. 26 is a schematic isometric view of the ICI of FIG. 24.

[0277] Turning to FIG. 23, the shim 430 has a first shim-side 431 A and a second shim-side 43 IB opposing the first shim-side 431 A. The shim 430 may include a shim body 432 and a perforated sealing gasket 440. The shim body 432 has a first cylindrical portion 432A having a diameter D2 and a height H5. The shim body 432 has a second cylindrical portion 432B having a diameter DI and a height H4. The shim body 432 has multiple cylindrical hollow passages passing therethrough. For example, the cylindrical hollow passages 437 and 438 may be seen in the cross- sectional view of FIG. 23. However, other cylindrical hollow passages (not shown in FIG. 23) are included in the shim body 432 that correspond to each of the remaining sensing and or stimulating electrodes of the ICI 400 of FIG. 24.

[0278] The hollow passage 437 has a first circular opening 437B opening on a first surface 432D of the shim body 432 and a second circular opening 437A opening on the second surface 432C of the shim body 432. The hollow passage 438 has a first circular opening 438B opening on the first surface 432D of the shim body 432 and a second circular opening 438 A opening on the second surface 432C of the shim body 432. The diameter DI of the second cylindrical portion 432B is smaller than the diameter D2 of the first portion 432A (Dl< D2). The shim 430 may also include a perforated sealing gasket 440. The perforated sealing gasket 440 has multiple circular perforations. For example, the circular perforations 440A and 440B shown in the cross-sectional view of FIG. 23 are circular perforations having a diameter equal to the diameters of the circular stimulating electrodes 408A-408D of the ICI 400 of FIG. 24. The perforated sealing gasket may be made from an elastic and / or flexible material as described in detail hereinabove with respect to the perforated sealing gasket 330 of FIG. 21. It is noted that in some embodiments, the perforated gasket 440 may be attached to the shim 430 by a suitable adhesive. In other embodiments, the perforated gasket 440 may be attached to the first ICI-side 401A of the ICI 400 (of FIG. 24) by a suitable adhesive. In some other embodiments the perforated gasket 440 may be separately provided and is not attached to neither the shim 430 nor to the ICI 400 and may be added before attaching the shim 430 to the ICI 400. In all three such embodiments, the thickness of the perforated sealing gasket 440 may be made thin enough to be neglected (as compared to the combined thicknesses of the ICI 400 and the shim 430.

[0279] The perforated sealing gasket 440 may be attached to the first surface 432D of the shim body 432 by a suitable adhesive as described in detail with respect to the perforated sealing gasket 330 of FIG. 21. The thickness H7 of the perforated sealing gasket may be much smaller than the thickness of the shim 430 such that H7<< (H4+H5).

[0280] The shim body 432 also includes an attachment mechanism for attaching the shim 430 to the ICI 400. The attachment mechanism may include two cylindrically shaped side-pins 435 and 436 protruding radially from the second portion 432B of the shim body 432 as illustrated in FIG. 23. The diameter D4 of the side-pin 435 is larger than the diameter D5 of the side-pin 436.

[0281] Turning to FIGS. 24-26, The ICI 400 has a first ICI-side 401A and a second ICI-side 401B. The ICI 400 may include a housing 404 and a lid 412. An electronics module 422 (similar to the electronics module 306 of FIG. 22) is disposed within the housing 404 that is hermetically sealed by the lid 412. The ICI 400 also includes four circular stimulating electrodes 408A-408D (best seen in FIG. 24), an annular current return electrode 408F (best seen in FIG. 25), and four circular sensing / recording electrodes 410A-410D. The stimulating electrodes 408A-408D and the sensing / recording electrodes 410A-410D are arranged on a circular surface 400A of the first ICI- side 401A as illustrated in FIG. 24. The electrodes 408A-408D, 408F and 410A-410D are suitably electrically connected to the electronics module 422.

[0282] The housing 404 may be hermetically sealed by a lid 412. The lid 412 has a male threaded part 412A that may be screwed into a corresponding female threaded portion 404B formed in the housing 404. The lid 412 may also include two side-tabs 464A and 464B (best seen in FIG. 24) having holes 464C and 464D, respectively. The side-tabs 464A and 464B may be used to attach the ICI 400 to the surface of the calvarial bone after implantation as disclosed in detail for the sidetabs 84A and 84B of the ICI 80 of FIGS. 6 and 7.

[0283] The housing 404 has a rim 404A extending therefrom on the first ICI-side 401A. The rim 404A has two keyed recesses 445 and 446 formed therein. The keyed recess 445 has a receiving opening 445A positioned at the surface 404B of the rim 404A and having dimensions suitable for receiving the cylindrical side-pin 435 (of the shim 430 of FIG. 23) therein. The width of the receiving opening 445A is Ml. The keyed recess 446 has a receiving opening 446A positioned at the surface 404B of the rim 404A radially opposite the keyed recess 445 and having a width M2. The keyed recess 446 has dimensions suitable for receiving the cylindrical side-pin 436 (of the shim 430 of FIG. 23) therein. It is noted that M1>M2, M1=D4 and M2=D5. The external diameter D3 of the rim 404A may be equal to the external diameter D2 of the shim 430 as illustrated in FIGS. 23-25. However, in some embodiments, D2>D3 and is some other embodiments D3>D2.

[0284] When the shim 430 is attached to the ICI 400, the shim 430 is rotated until the larger sidepin 435 is positioned above the receiving opening 445A and the smaller side-pin 436 is positioned above the receiving opening 446A. The shim 430 is then pushed towards the ICI 400 until the side-pin 435 enters keyed recess 445 and the side -pin 436 enters the keyed recess 446. The shim 430 is simultaneously pushed towards the ICI 400 and rotated clockwise until the side-pin 435 moves downwards and is caught within a slightly upward curving portion 447 of the keyed recess 445 and the side-pin 436 moves downwards within the keyed recess 446 and is caught within a slightly upward curving portion 448 of the keyed recess 446, effectively locking the shim 430 to the ICI 400. The side-pins 435 and 436 are pushed upwards and held within the upward curving portions 447 and 448 of the keyed recesses 445 and 446, respectively, by the spring force exerted by the compressed perforated sealing gasket 440 on the shim 430 which spring force is trying to push the shim 430 away from the ICI 400.

[0285] It is noted that it is not possible to insert the larger side-pin 435 into the smaller receiving opening 446A of the keyed recess 446. This attaching mechanism prevents attaching the shim 436 in the wrong polarity and ensures correct alignment of the perforations of the sealing gasket 440 with respect to the correct stimulating electrodes 408A-408D and the sensing / recording electrodes 410A-410D of the ICI 400.

[0286] If it is needed to separate between the ICI 400 and the shim 430 after they are attached to each other and locked together, it is necessary to rotate the shim 430 counter-clockwise while applying a sufficient force required to remove the side-pins 435 and 436 from the upward curving portions 447 and 448 of the keyed recesses 445 and 446, respectively. After the side-pins 435 and 436 exit the upwards curving portions 447 and 448, respectively, the shim 430 may be rotated counter-clockwise and pulled away from the ICI 400. It is noted that the effective thickness of the ICI 400 is B which does not include the thickness ST of the side-tabs 464A and 464B (best seen in FIG. 24) included in the lid 412 of the ICI 400. It is noted that the attachment mechanisms of the shims of the present application are not limited to the type illustrated in FIGS. 21-26 and that any suitable types of attachment mechanisms known in the art may be used for attaching the shim to an ICI. Some non-limiting types of attaching mechanisms are illustrated in FIGS. 27-32 hereinafter.

[0287] Reference is now made to FIGS. 27-29. FIG. 27 is a schematic cross-sectional diagram illustrating a shim including a keyed bayonet type attachment mechanism including two securing members, in accordance with an embodiment of the shims of the present application. FIG. 28 is a schematic bottom view of an ICI including two keyed recesses for receiving the two securing members of the shim of FIG. 27. FIG. 29 is a schematic cross-sectional view of the ICI of FIG. 28, taken along the lines XXIX-XXIX.

[0288] Turning to FIG. 29, the ICI 500 has a first ICI-side 501A and a second ICI-side 501B opposing the first ICI-side 501 A. The ICI 500 may include a housing 504 and a lid 512. An electronics module 522 (similar to the electronics module 306 of FIG. 22) is disposed within the housing 504 that is hermetically sealed by the lid 512. The ICI 500 also includes four circular stimulating electrodes 508A-508D (best seen in FIG. 28), an annular current return electrode 508F (best seen in FIG. 29), and four circular sensing / recording electrodes 510A-510D arranged on a circular surface 504A of the housing 504 on the first ICI-side 501A, as illustrated in FIG. 28. The electrodes 508A-508D, 508F and 510A-510D are suitably electrically connected to the electronics module 522

[0289] The lid 512 (best seen in FIG. 28) may also include two side-tabs 464A and 464B (best seen in FIG. 24) having holes 464C and 464D, respectively, formed therein. The side-tabs 464A and 464B may be used to attach the ICI 400 to the surface of the calvarial bone as disclosed in detail for the side-tabs 84A and 84B of the ICI 80 of FIGS. 6 and 7. It is noted that in embodiments of the ICI that include the side-tabs, the effective thickness of the ICI 500 is B which does not include the thickness ST of the side-tabs 564A and 564B (best seen in FIG. 28) that may be used to attach the ICI 500 to the surface of the calvarial bone.

[0290] The housing 504 has a rim 504B surrounding a cylindrical recess 504D. The recess 504D has a circular bottom surface 504A. The electrodes 508A-508D and the electrodes 510A-510D are exposed on the bottom surface 504A of the recess 504D. The rim 504B has two keyed recesses 545 and 546 formed therein. The keyed recess 545 has a receiving opening 545A positioned at the surface 504C of the rim 504A. The receiving opening 545A has dimensions suitable for receiving the cylindrical head 535A of the rivet-like protrusion 535 of the shim 530 therein. The keyed recess 546 has a receiving opening 546A positioned at the surface 504B of the rim 504A radially opposite the keyed recess 545. The receiving opening 546A of the keyed recess 546 has dimensions suitable for receiving the head 536A of the rivet-like protrusion 536 therein. It is noted that P2>P4, P1=K1, P2=K2 P3=K3 and P1>P3. The external diameter D8 of the rim 504A may be equal to the external diameter D7 of the shim 530 as illustrated in FIGS. 23-25. However, in some embodiments, D8>D7 and is some other embodiments D7>D8.

[0291] Turning to FIG. 27, the shim 530 may include a shim body 532 and a perforated sealing gasket 540 attached thereto. The shim body 532 has a first shim-side 531 A attachable to the first ICI-side 501A (of FIGS. 28-29). The shim 530 has a second shim-side 53 IB opposing the first shim-side 531 A. The shim body 532 has a first cylindrical portion 532A having a diameter D7 and a height H7. The shim body 532 has and a second cylindrical portion 532B having a diameter D6 and a height H6. The shim body 532 has multiple cylindrical hollow passages passing therethrough. For example, the cylindrical hollow passages 537 and 538 may be seen in the cross- sectional view of FIG. 27. However, other cylindrical hollow passages (not shown in FIG. 27) are included in the shim body 532 that correspond to each of the remaining sensing / recording and / or stimulating electrodes of the ICI 500 of FIG. 28.

[0292] The hollow passage 537 has a first circular opening 537B opening on a first surface 532D of the first shim-side 531 A and a second circular opening 537A opening on a second surface 532C of the second shim-side 53 IB. The hollow passage 538 has a first circular opening 538B opening on the first surface 532D of the first shim-side 531 A and a second circular opening 538A opening on the second surface 532C of the second shim-side 53 IB. The diameter D6 of the second cylindrical portion 532B is smaller than the diameter D7 of the first portion 532A (D6<D7). The shim 530 may also include a perforated sealing gasket 540. The perforated sealing gasket 540 has multiple circular perforations. For example, the circular perforations 540A and 540B shown in the cross-sectional view of FIG. 27 are circular perforations having a diameter equal to the diameters of the circular stimulating electrodes 508A-508D of the ICI 500 of FIGS. 28-29. The perforated sealing gasket 540 may be made from an elastic and / or flexible and / or compressible material as described in detail hereinabove with respect to the perforated sealing gasket 330 of FIG. 21.

[0293] In some embodiments, the perforated sealing gasket 540 may be attached to the first surface 532D of the shim body 532 by a suitable adhesive as described in detail with respect to the perforated sealing gasket 330 of FIG. 21. The thickness H8 of the perforated sealing gasket 540 may be much smaller than the effective thickness H7 of the shim 530 such that H8<< (H6+H7). In other embodiments, the perforated sealing gasket 540 may be attached (by a suitable adhesive) to the circular bottom surface 504A of the cylindrical recess 504D of the first ICI-side 501A. In some embodiments, the perforated sealing gasket 540 is provided as a separate part that is not attached to the shim 530 or to the ICI 500. In such embodiments the perforated sealing gasket 540 may be placed on the bottom surface 504A of the recess 504D with proper alignment of the perforations with their respective electrodes.

[0294] The shim body 532 also includes an attachment mechanism for attaching the shim 530 to the ICI 500. The attachment mechanism includes two rivet-like portions 535 and 536 protruding from the first portion 532A of the shim body 532 as illustrated in FIG. 27. The rivet-like portion 535 has a first cylindrical portion 535A having a diameter P2 and a second cylindrical portion 535B having a diameter Pl wherein P2>P1. The rivet-like portion 536 has a first cylindrical portion 536 A having a diameter P4 and a second cylindrical portion 536B having a diameter P3 wherein P4>P3. It is noted that P2>P4.

[0295] When the shim 530 is attached to the ICI 500, the second cylindrical portion 532B of the shim body 532 is inserted into the recess 504D of the ICI 500 and rotated until the larger rivet-like protrusion 535 is positioned above the opening 545A and the smaller rivet like 536 is positioned above the receiving opening 546A. The shim 530 is then pushed further towards the ICI 500 until the first cylindrical portion 535A is fully seated within the keyed recess 545 and the second cylindrical portion 536A is fully seated within the keyed recess 546. The shim 530 may then be rotated clockwise until the portion 535A slides within the narrow portion 545B of the recess 545 to the end of the recess 545 and is caught within a slightly inward curving portion 545C of the keyed recess 545. At the same time, the cylindrical portion 536B slides counter-clockwise within the keyed recess 546 and is caught within a slightly inward curving portion 546C of the keyed recess 546 firmly locking the shim 530 to the ICI 500. The rivet-like portions 535 and 536 are locked within the inward curving portions 545C and 546C of the keyed recesses 545 and 546, respectively, because a certain minimal force is required to push the protrusions 545 and 546 out of the portions 545C and 546C, respectively.

[0296] It is noted that it is not possible to insert the cylindrical potion 535A into the receiving opening 546A of the keyed recess 546 because the diameter P2 of the cylindrical potion 535A is too large to fit within the receiving opening 546A of the keyed recess 546. This keyed attaching mechanism prevents attaching the shim 530 to the ICI 500 in the wrong polarity and ensures correct alignment of the perforations of the sealing gasket 540 with respect to the correct stimulating electrodes 508A-508D and the sensing electrodes 510A-510D of the ICI 500.

[0297] If it is desired to separate between the ICI 500 and the shim 530 after they are attached to each other and locked together, it is necessary to rotate the shim 530 counter-clockwise while applying a sufficient force required to release the rivet-like protrusions 535 and 536 from the inward curving portions 545C and 546C of the keyed recesses 545 and 546, respectively. After the rivet-like protrusions 535 and 536 exit the inward curving portions 545C and 546C, respectively, the shim 530 may be rotated counter-clockwise and pulled away from the ICI 500.

[0298] Reference is now made to FIGS. 30-32. FIG. 30 is a schematic bottom view of a shim having a keyed bayonet type attaching mechanism including two keyed recesses, in accordance with an embodiment of the shims of the present application. FIG. 31 is a schematic cross-sectional view of the shim of FIG. 30, taken along the lines XXXI-XXXI. FIG. 32 is a cross sectional view illustrating an ICI attachable to the shim of FIGS. 30-31.

[0299] Turning to FIG. 32, the ICI 600 has a first ICI-side 601A and a second ICI-side 601B opposing the first ICI-side 601A. The ICI 600 may include a housing 604 and a lid 612. An electronics module 622 (similar to the electronics module 306 of FIG. 22) is disposed within the housing 604 that is hermetically sealed by the lid 612. The ICI 600 also includes four circular stimulating electrodes 608A-608D arranged on a circular surface 604A of the housing 604. It is noted that only the stimulating electrodes 608A and 608B are seen in the cross-sectional view of FIG. 32 but the position of the remaining stimulating electrodes 608C and 608D may be inferred from the positions of the perforations 640C and 640D of the perforated sealing gasket 640 of FIG. 30. The ICI 600 also includes an annular current return electrode 608F and four circular sensing / recording electrodes 610A-610D arranged on the circular surface 604A of the housing 504. It is noted that the sensing / recording electrodes 610A-610D are not seen in the cross- sectional view of FIG. 32 but their positions can be inferred from the positions of the perforations 640A-640D of the perforated sealing gasket 640 of FIG. 30. The electrodes 608A-608D, 608F and 610A-610D are suitably electrically connected to the electronics module 622.

[0300] The housing 604 has a rim 604B surrounding a cylindrical recess 604D having a depth H9.

[0301] The housing 604 also includes an attachment mechanism for attaching the ICI 600 to the shim 630 of FIGS. 30-31. The attachment mechanism includes two rivet-like portions 635 and 636 protruding from a surface 604C of the rim 604B as illustrated in FIG. 32. The rivet-like portion 635 has a first cylindrical portion 635A having a diameter N1 and a second cylindrical portion 635B having a diameter N2, where N1>N2. The rivet-like portion 636 has a first cylindrical portion 636A having a diameter QI and a second cylindrical portion 636B having a diameter Q2 wherein Q1>Q2. It is noted that N1>Q1. The external diameter Dll of the rim 604B may be equal to the external diameter D10 of the shim 630 as illustrated in FIGS. 30-32. However, in some embodiments Dll>D10 and is some other embodiments D10>Dll.

[0302] It is noted that the effective thickness of the ICI 600 is B which does not include the thickness ST of the side-tabs (not shown in the cross-sectional view of FIG. 28) that may be included in the lid 612. The side-tabs of the lid 612 may be similar to the side-tabs 564A and 564B of the ICI 500 of FIG. 28.

[0303] Turning to FIGS. 30-31, the shim 630 has a first shim-side 601A and a second shim-side 601B opposing the first shim-side 601A. The shim 630 may include a shim body 632 and a perforated sealing gasket 650 attached to a first surface 632D of the first shim-side 631 A of the shim body 632. The shim body 632 has a first cylindrical portion 632A having a diameter D10 and a height Hll. The shim body 632 has a second cylindrical portion 632B having a diameter D9 and a height H9. The shim body 632 has four cylindrical hollow passages 637, 638, 639, 640 passing therethrough. For example, the cylindrical hollow passages 637 and 638 may be seen in the cross-sectional view of FIG. 31. The shim body 632 has four additional cylindrical hollow passages 612A-612D (best seen in FIG. 30 as underlying four circular perforations 614A-614D, respectively, that are formed in the perforated sealing gasket 650).

[0304] The hollow passage 637 has a first circular opening 637B opening on a first side 632D of the shim body 632 and a second circular opening 637A opening on the second side 632C of the shim body 632. The hollow passage 638 has a first circular opening 638B opening on the first surface 632D of the first shim-side 631 A and a second circular opening 638A opening on a second surface 632C of the second shim-side 63 IB. The diameter D9 of the second cylindrical portion 532B is smaller than the diameter D10 of the first portion 532A (D9< D10). The perforated sealing gasket 650 has multiple circular perforations. For example, the circular perforations 640A and 640B shown in the cross-sectional view of FIG. 31 are circular perforations having a diameter equal to the diameters of the circular stimulating electrodes 608A-608D of the ICI 600. The perforated sealing gasket 650 may be made from an elastic and / or flexible and / or compressible material as described in detail hereinabove with respect to the perforated sealing gasket 330 of FIG. 21.

[0305] The perforated sealing gasket 650 may be attached to the first surface 632D of the shim body 632 by a suitable adhesive as described in detail with respect to the perforated sealing gasket 330 of FIG. 21. The thickness H10 of the perforated sealing gasket 650 may be much smaller than the effective thickness Hll of the shim 630 such that H10<< (H9+H11).

[0306] The shim body 632 also includes an attachment mechanism for attaching the shim 630 to the ICI 600. The attachment mechanism includes two keyed recesses 645 and 646 formed therein. The keyed recess 645 has a receiving opening 655A positioned at the surface 632E of the shim body 632. The receiving opening 655A has dimensions suitable for receiving the first cylindrical portion 635A of the rivet-like protrusion 635 of the rim 604B of the ICI 600 therein. The keyed recess 646 has a receiving opening 656 positioned at the surface 632E of the shim body 632. The receiving opening 656 is positioned radially opposite the receiving opening 655 of the keyed recess 545. The receiving opening 656 of the keyed recess 646 has dimensions suitable for receiving the cylindrical portion 636A of the rivet-like protrusion 636 therein.

[0307] When the shim 630 is attached to the ICI 600, the second cylindrical portion 632B of the shim body 632 is inserted into the recess 604D of the ICI 600 and rotated until the larger rivet-like protrusion 635 of the ICI 600 is positioned above the receiving opening 655 of the shim 630 and the smaller rivet like 636 of the ICI 600 is positioned above the receiving opening 656 of the ICI 600. The shim 630 is then pushed further towards the ICI 600 until the first cylindrical portion 635A is fully seated within the keyed recess 645 and the cylindrical portion 536A is fully seated within the keyed recess 646. The ICI 600 is then rotated clockwise until the portion 635A of the rivet-like protrusion 635 slides within the narrow portion 645B of the keyed recess 645 to the end of the recess 645 and is caught within a slightly inward curving portion 645C of the keyed recess 645. At the same time, the cylindrical portion 636B slides counter-clockwise within the keyed recess 646 and is caught within a slightly inward curving portion 646C of the keyed recess 646 firmly locking the shim 630 to the ICI 600. The rivet-like portions 635 and 636 are locked within the inward curving portions 6545C and 646C of the keyed recesses 645 and 646, respectively, because a certain minimal force is required to push the protrusions 645 and 646 out of the portions 645C and 646C, respectively.

[0308] It is noted that it is not possible to insert the cylindrical potion 635A into the receiving opening 656 of the keyed recess 646 because the diameter N1 of the cylindrical potion 535A is too large to fit within the receiving opening 656 of the keyed recess 546 that has a diameter QI. This keyed attaching mechanism prevents attaching the shim 636 to the ICI 600 in the wrong polarity and ensures correct alignment of the perforations of the sealing gasket 650 with respect to the correct stimulating electrodes 608A-608D and the sensing electrodes 610A-610D of the ICI 600.

[0309] If it is needed to separate between the ICI 600 and the shim 630 after they are attached to each other and locked together, it is necessary to rotate the shim 630 clockwise with respect to the ICI 600 while applying a sufficient force required to release the rivet-like protrusions 635 and 636 from the inward curving portions 645C and 646C of the keyed recesses 645 and 646, respectively. After the rivet-like protrusions 535 and 536 exit the inward curving portions 545C and 546C, respectively, the shim 630 may be rotated counter-clockwise with respect to the ICI 600 and pulled away from the ICI 600.

[0310] It is noted that in some embodiments, the perforated sealing gasket 650 may be attached (by a suitable adhesive) to the circular bottom surface 604 A of the cylindrical recess 604D of the first ICI-side 601A. In some embodiments, the perforated sealing gasket 650 is provided as a separate part that is not attached to the shim 630 or to the ICI 600. In such embodiments the perforated sealing gasket 650 may be placed on the bottom surface 604A of the recess 604D with proper alignment of the different perforations with their respective electrodes.

[0311] It is noted that the different exemplary types of attachment mechanisms illustrated in FIGS. 21-32 are not intended to be limiting and that many other different types of attaching mechanisms (either keyed or not keyed) may be used to attach the ICI to the shims of the present application, all of which are intended to be included within the scope of the term attachment mechanism(s).

[0312] Several different types of manufacturing methods may be used for making the shims of the present application. Shims having hollow passages (such ss, for example, the shims 20, 100, 120, 200, 230, 240, 250, 260, 270, 280, 300, 340, 430, 530 and 630) may be made using additive manufacturing methods or by subtractive manufacturing methods. Subtractive manufacturing methods may include, for example, drilling, milling, laser cutting and laser ablating. Drilling may be used for forming the hollow passages of shims that have hollow passages having a cylindrical shape (such as, for example, the shims 260 340, 430, 530 and 630) while milling may be used for forming any straight hollow passages having a uniform cross-sectional shape or having an axis of symmetry orthogonal to the first or to the second surface of the shim surface such as, for example, the shims 20, 100, 120, 200, 230, 240, 260, 300, 340, 430, 530 and 630.

[0313] Laser cutting methods may be used for forming any cylindrically shaped hollow passage included in any of the shims (such as, for example, the shims 260 340, 430, 530 and 630) or for forming any straight (non-curving) hollow passage having a uniform cross section included in shims such as the shims 20, 100, 120, 260, 300, 340, 430, 530 and 630.

[0314] Laser ablation methods may also be used for forming some of the hollow passages of the shims of the present application.

[0315] It is noted the additive manufacturing methods, such as, for example, Hi-resolution 3D printing methods, are particularly suitable for manufacturing any of the shims disclosed in the present application due to several advantages. The first advantage is that such 3D printing methods may produce the entire shim body including all the hollow passages and attachment mechanism (excluding any perforated sealing gasket) in a single printing run. Moreover, using a 3D printer having two printing heads (one printing head for printing a first thermoplastic material for forming the shim body and a second printing head for printing a thermoplastic elastomer for forming the perforated sealing gasket of the shim), it may be possible to manufacture an entire shim including the perforated sealing gasket in a single printing run (advantageously avoiding the need to separately manufacture a perforated sealing gasket and the need to properly align the perforated sealing gasket with respect to the shim body and the using of an adhesive to attach the perforated sealing gasket to the shim body).

[0316] A second advantage of using 3D printing methods is that 3D printing enables the forming of any of the hollow passages disclosed in the present application, including irregularly shaped hollow passages having a non-uniform cross-sectional shape (for example, the hollow passages 225 and 226 of FIG. 12, the hollow passages 235 and 236 of FIG. 13 and the hollow passages 245 and 246 of FIG. 14), bifurcating passages (such as, for example, the passages 255 and 256 of FIG. 15, curving hollow passages (such as, for example, the hollow passage 276 of FIG. 17), irregularly shaped bifurcating hollow passages (such as, for example, the hollow passage 285 of FIG. 18) or any other desired type or shape of a hollow passage.

[0317] As each of the shims disclosed in the application may be specifically adapted to a specific individual patient and to a specific implantation site of such a specific individual patient and not produced using mass production methods, it may be useful and cost-effective to use such 3D printing methods despite the fact that they may be slower than some of the subtractive manufacturing methods described above.

[0318] Several methods may be used for making the shims that have passages filled with an electrically conducting material such as, for example, the shim 140 of FIG. 8 and the shim 150 of FIG. 9.

[0319] Returning to FIG. 8, a first exemplary method for making the shim 140 may be to first form the shim body 42 including the passages 142A and 142B (using any of the additive or subtractive methods disclosed hereinabove for making shims with hollow passages therein), separately making the solid members 145 and 146 from a suitable electrically conducting material and then attaching the solid bodies 145 and 146 within the passages 142A and 142B using a suitable biocompatible adhesive material.

[0320] Reference is now made to FIG. 33, which is a schematic cross-sectional diagram illustrating a step of a method for making the shim of FIG. 8, in accordance with an embodiment of the methods of manufacturing the shims of the present application.

[0321] Turning to FIG. 33, the solid bodies 145 and 146 are attached to the bottom surface 700A of an open mold 700 using a very thin layer (not shown) of a suitable adhesive applied to the surfaces 145C and 146D of the solid members 145 and 146, respectively. The open mold 700 has a cylindrical shape having an inner diameter D12, equal to the outer diameter D13 of the shim body 142. The open mold 700 may be made from any suitable flexible or elastic material, such as, for example, butadiene rubber, PDMS, or any other suitable elastomer. After the solid bodies are firmly attached to the bottom surface 700A, a polymerizable liquid 670 is poured into the open mold 700 to a height H15 that is larger than the height H14 of the solid bodies 145 and 146. The polymerizable liquid 670 is then allowed to polymerize and / or crosslink (if the polymerizable liquid already includes a polymerization initiator) or polymerization is initiated by ultraviolet (UV) light irradiation (if the polymerizable liquid requires UV irradiation for initiating polymerization). After polymerization is completed the resulting polymer body including the embedded solid members 145 and 146 is removed from the open mold 700 and further processed by milling or other subtractive machining method to remove excess polymer covering the surfaces 145A and 146B of the solid members 145 and 146, respectively. The surfaces 145C and 146D may then be cleaned from any leftovers of the adhesive used to attach them to the surface 700A of the mold 700.

[0322] The polymerizable liquid 670 may be a single UV polymerizable monomer or a mixture containing a liquid monomer including a polymerization initiator and / or a cross -linking initiator or a liquid containing two or several different monomers that may polymerize to form a desired co-polymer. Any such polymerizable liquids may be used as long as they polymerize to a suitable biocompatible solid polymer forming the shim 140. Such polymers are disclosed in detail with respect to the shim 20 of FIG. 3. This method may be particularly suitable for making shims with filled passages similar to the hollow passages 255 and 256 (of FIG. 15) or the hollow passage 276 (of FIG. 17) or the hollow passage 285 (of FIG. 18) if such convoluted, or branching or irregularly shaped hollow passages need to be filled with a solid body made from an electrically conducting material.

[0323] Returning briefly to FIG. 9, one possible method for making a shim having passages filled with a semi-solid electrically conducting material (such as, for example, the shim 150 Of FIG. 9) is disclosed hereinbelow.

[0324] Reference is now made to FIG. 34, which is a schematic cross-sectional view illustrating a step of a method for making the shim of FIG. 9.

[0325] The method includes forming the shim body 152 with the passages 152A and 152B being hollow passages by any of the methods disclosed hereinabove for making shims with hollow passages. The method also includes temporarily attaching the shim body 152 to a flat substrate 715 by a thin layer of an adhesive (not shown in FIG. 34 for the sake of clarity of illustration) or by applying pressure on the surface 152D of the shim body 152 and then pouring a polymerizable liquid 157 into the hollow passages 152A and 152B until they are filled with the polymerizable liquid 157. In FIG. 34 the passage 152A is shown as completely filled with the polymerizable liquid 157 and the hollow passage 152B is shown partially filled with the polymerizable liquid 157 that is being poured into the passage 152B from a suitable pipette 720 that contains the polymerizable liquid 157. After the passages 152A and 152B are completely filled with the polymerizable liquid 157, the liquid 157 may be polymerized (and / or cross-linked) to form the semi-solid hydrogel 155 (illustrated in FIG. 9). The polymerization may be initiated by irradiating the polymerizable liquid 157 by UV radiation or by mixing a suitable polymerization initiator into the polymerizable liquid 157 prior to filling of the passages 152A and 152B with the liquid 157. The polymerizable liquid 157 may include suitable monomer or polymer precursors for forming a semi-solid electrically conducting biocompatible hydrogel 155, as disclosed in the articles by Anthony Guiseppi-Elie and Richard Balint et al. referenced hereinabove.

[0326] It is noted that while the hollow passages 255 and 256 (of FIG. 15) are bifurcating passages, this is not limiting and the shims of the present application may include any number of hollow passages that may have more than two branches or any desired number of branches opening on a first side of the shim body and any desired number of branches opening on the second side of the shim. For example, a hollow passage in a shim may include a single opening on the first side of the shim facing the ICI which may circumscribe one or more stimulating electrodes and multiple different openings on the second side of the shim. In another example, a hollow passage in a shim may include a single opening on the second side of the shim and multiple different openings on the first side of the shim that faces the ICI and each one of these openings on the first side of the shim may circumscribe one stimulating electrode or multiple stimulating electrodes.

[0327] Reference is now made to FIG. 35 which is a schematic isometric view of a shim having branching hollow passages having multiple lumen branches, in accordance with an embodiment of the shims of the present application. The shim 650 is a cylindrically shaped or disc-like shim having a shim body 652. The shim 650 has a first shim-side 651 A and a second shim-side 65 IB opposing the first shim-side 651 A. The first shim-side 651 A has a first surface 652D that may face an ICI (not shown) when the shim 650 is attached to the side of the ICI that includes stimulating electrodes (not shown in FIG. 35). The shim body 652 has a second surface 652C. The thickness HM of the shim 650 (which is also the effective thickness of the shim 650) equals the distance between the first surface 652D and the second surface 652C of the shim 650.

[0328] The shim body 652 has two hollow passages 655 and 666 formed therein. The hollow passage 655 is a branching hollow passage that has a first opening 655B that opens on the first surface 652D of the shim body 652 and three openings 655A,655C and 655D that open on the second surface 652C of the shim body 652. The hollow passage 656 is also a branching hollow passage that has a first opening 666A that opens on the second surface 652C of the shim body 652 and three openings 666A,666C and 666D that open on the first surface 652D of the shim body 652.

[0329] When the first surface 652D of the shim 650 is attached to an ICI (not shown in FIG. 35) having multiple stimulating electrodes, the opening 655B of the hollow passage 655 may circumscribe one stimulating electrode or multiple stimulating electrodes of the ICI and each one of the openings 666B, 666C and 666D may circumscribe a single stimulating electrode or multiple stimulating electrodes.

[0330] It is noted that the number of branches of the hollow passages of the shims of the present application is not limited to two or three branches per hollow passage and that the hollow passages may have any suitable number of branches opening on either the first shim- side or the second shim-side of the shims. However, when designing the number of branches and the cross-sectional area of the openings on the second shim-side (the side of the shim that is closer to the stimulation target(s)), it should be born in mind that small openings that have a small cross-sectional area may need to be avoided because the resistance to electrical current flow through such small openings may limit the amount of current flowing through such an opening during stimulation due to compliance voltage limits. It should also be born in mind that when a hollow passage (filled with an electrically conducting liquid) that has several differently sized openings on the second side of the shim is used for stimulation as explained in detail hereinabove, the current flowing through each opening may depend on the electrical resistance of each of the openings with higher electrical currents flowing through openings having a larger cross-sectional area.

[0331] Another consideration is that the current density under openings 655A, 655C and 655D of the hollow passage 655 of the shim 650 when the hollow passage is filled with an electrically conducting liquid may depend on several factors including, inter alia, the number of stimulating electrodes circumscribed by the opening 655B, the total cross-sectional area of the surfaces of the all stimulating electrodes circumscribed by the opening 655B, the voltage difference between the stimulating electrodes and the current return electrode(s) of the ICI (not shown), the geometrical shape and position of the current return electrode on the ICI, the dimensions of the branches of the hollow passage 655, the electrical resistance of the liquid filling the hollow passage 655, and other considerations.

[0332] It is noted that similar or other considerations should be taken into account if the passage 655 is not a hollow passage and is filled with an electrically conducting material as described with respect to FIGS. 8 and 9. For example, such additional considerations may include, inter alia, the electrical resistance of the solid or semi-solid or hydrogel filling the passages of the shim. It will be appreciated that using any or all of the above passage design considerations it may be possible to finely tune the current density distribution under the side of the shim that faces the stimulation target(s) after implantation of the assembly including an ICI and a shim attached thereto. This may advantageously allow personal adaptation of the shim to any specific variation in the configuration of cortical stimulation targets (or other non-cortical brain regions) that may be detected and localized in each individual patient using the combined results of the fMRI and CT (or other anatomical tomography method) imaging, as disclosed hereinabove.

[0333] It is noted that when using passages having a large passage opening at electrode side that narrows down to a small opening over the cortical region to be stimulated, it is advisable to avoid excessive narrowing of the passage towards the side facing the cortical target as this may cause too high a current density at the smaller opening of the passage which may undesirably heat up target tissues.

[0334] It is further noted that any of the types of hollow passages disclosed in the present application and illustrated in the present application and illustrated in the drawing figures may also be implemented as a passage filed with an electrically conducting solid or semi-solid (including electrically conducting hydrogels). Furthermore, in some embodiments of the shims, different combinations of hollow passages and passages filed with an electrically conducting materials may be used in the same shim. For example, a shim may be made that is similar to the shim 630 of FIG. 31 with the exception that the passages 637-640 circumscribing the stimulating electrodes (of the ICI 530 of FIG. 29) are hollow passages while the passages 612A-612D are filled with an electrically conducting solid as disclosed hereinabove. In another example, a shim may be made that is similar to the shim 630, with the exception that the passages 637-640 are filled with a semisolid electrically conducting hydrogel and the passages 612A-612D are filled with an electrically conducting solid as disclosed hereinabove. In another example, all the passages 612A-612D and 637-640 are filled with an electrically conducting solid as disclosed hereinabove. In another example, all the passages 612A-612D and 637-640 are filled with an electrically conducting hydrogel as disclosed hereinabove. Any other combinations and permutations of hollow and filled passages is possible and may be used in implementing the shims of the present application.

[0335] While all the ICIs disclosed hereinabove are implemented as an integrated one-piece ICI in which all the components required for the operation of the ICI are included within a single housing of the ICI (which components may include an inductance coil for energy harvesting and a magnet for attaching a magnetic energizing pod to the head of the patient), this is not limiting and the shims of the present application may be used with ICIs implemented as a two-part ICI (as disclosed in more details in international published applications WO2019 / 130248, W02020 / 050527 and WO2020 / 161555.

[0336] Reference is now made to FIGS. 36-37. FIG. 36 is a schematic cross-sectional view illustrating an assembly including a two-part ICI and a shim attached thereto implanted within a recess made in the calvarial bone of a patient, in accordance with an embodiment of the shims of the present application. FIG. 37 is a schematic cross-sectional view illustrating an assembly including a two-part ICI and a shim attached thereto that are implanted in a hole passing through the calvarial bone of a patient with a side of the shim reaching the dura matter, in accordance with an embodiment of the shims of the present application.

[0337] Turning to FIG. 36, the shim 100 is identical to the shim 100 illustrated in FIG. 6 and has an effective thickness H. However, the ICI 900, is a two-part ICI including a first ICI-part 700 and a second ICI-part 800. The first ICI-part 700 may include a cylindrical housing 704, an electronics module 706 hermetically sealed within the housing 704. The first ICI-part 700 may include several stimulating electrodes (it is noted that only the stimulating electrodes 700 A and 700B are seen in the cross-sectional view of FIG. 36) and two contact pads 700C and 700D. The first ICI-part 700 may also include multiple sensing / recording electrodes (not seen in the cross-sectional view of FIG. 36) that may be similar to the sensing / recording electrodes 45A-45D of FIGS. 1 and 4, or to the sensing / recording electrodes 65A-65D of FIG. 10, or to the sensing electrodes 291A-291D of FIG. 19, or to the sensing / recording electrodes 410A-410D of FIG. 24, or to the sensing / recording electrodes 510A-510D of FIG. 28. However, it is noted that the sensing / recording electrodes of the first ICI-part 700 may also be different than any of the sensing / recording electrodes illustrated in FIGS. 1, 4, 10, 19, 24 and 28. Any suitable number of sensing / recording electrodes may be included in the first ICI-part 700 and any suitable geometrical arrangement of such sensing recording electrodes may be used in the first ICI-part 700. Furthermore, any suitable shape and / or cross-sectional area of such sensing / recording electrodes may be implemented in the first ICI-part 700. The first ICI-part 700 may also include an annular current return electrode 700F embedded in or attached to the housing 704 as illustrated in FIG. 36.

[0338] The second ICI-part 800 may include a housing 814 having a lid 812. The lid 812 may include two side-tabs 812A and 812B having screw holes 812C and 812D, respectively, formed therein. The side-tabs 812A and 812B may be used to attach the two-part ICI 900 to the outer surface 2A of the calvarial bone 2 using two bone screws 85A and 85B, respectively. The lid 812 may have a male threaded portion 812A that may be screwed into a female threaded portion 814A of the housing 814 to hermetically seal the second ICI-part 800. The second ICI-part 800 may also include an inductance coil 809 disposed within the housing 814 and suitably electrically connected to a pair of contact pads 800A and 800B by a pair of electrically insulated electrically conducting wires 813 and 815, respectively. The second ICI-part 800 may also include a disc-like magnet 805 and an annular spacer 807 surrounding the magnet 805 and made from a non-magnetic nonferromagnetic and electrically insulating material (such as, for example, Teflon® or another suitable biocompatible polymer). The annular spacer 807 centers the magnet 805 within the housings 14 and prevents lateral movement of the magnet 805 within the housing 814.

[0339] The magnet 805 may be a permanent magnet, such as, for example, an Iron Neodymium Boron ceramic magnet. And may be used for attaching an energizing pod (not shown) to the scalp overlying the second ICI-part 800 after implantation. The energizing pod may include another magnet for alignment purposes. Such energizing pods and their methods of operation and construction are described in detail in published international applications, electrical signals to the brain are disclosed, inter alia, in published international applications WO2021 / 144730 WO2019 / 130248 and WO2020 / 161555.

[0340] The effective thickness of the first ICI-part 700 is K. The effective thickness of the second ICI-part is S. The thickness of the calvarial bone 2 is Y and the thickness of the layer of bone remaining under the bottom surface 2C of the recess 2B is M. The effective thickness T of the two-part ICI 900 is T=S+K.

[0341] The two-part ICI 900 may be formed by attaching the first ICI-part 700 to the second ICI- part 800. The attaching of the first ICI-part 700 to the second ICI-part 800 (in the manner illustrated in FIG. 36) may be performed by using an adhesive applied to the surface of the first side 814 B of the second ICI-part 800, but not on the contact pads 800A and 800B and attaching it to the surface 700D of the first ICI-part 700 in such a way that the contact pads 800A and 800B are in contact with the contact pads 700C and 700D of the first ICI-part 700, respectively. However, in some embodiments of the two-part ICI 900, the first ICI-part 700 may be attached to the second ICI-part 800 using different attachment methods, similar to the methods disclosed for attaching the shims to the ICIs, such as, for example, different types of mechanical attachment mechanisms, such as, for example, bayonet mechanisms having keyed recesses (such as, for example, the keyed recesses 445 and 446 illustrated in FIG. 26 or the keyed recesses 545 and 546 illustrated in FIG. 28 or the keyed recesses 645 and 646) with corresponding side-pins (such as, for example, the side-pins 435 and 440 of FIG. 260, or with corresponding rivet-like protrusions (such as, for example, the rivet-like protrusions 535 and 536 of FIG. 27 or the rivet- like protrusions 635 and 636 of FIG. 32).

[0342] It is noted that even though all the bayonet type attachment mechanisms described herein have two side-pins or two rivet-like protrusions or two keyed slots or receiving slots, this is not obligatory and some embodiments of shims may include more than two side-pins or rivet-like protrusions or keyed slots or receiving slots.

[0343] Another possible type of attachment mechanism may be a male or female threaded part formed in the first ICI-part 700 with a corresponding female or male portion formed on the second ICI-part 800, respectively (such as, for example, the threaded portions 302A and 180C of the attachment mechanism of FIG. 21). Attachment of the shim 100 to the two-part ICI 900 may be performed by using a suitable adhesive to attach the first side 102A of thew Shim 100 to the first side 704A of the housing 704 of the first ICI-part as illustrated in FIG. 36 (it is noted that the adhesive is not shown in FIG. 36 for the sake of clarity of illustration). However, in some embodiments of the shim 100, it may be attached to the first ICI-part 700 by any one of the types of attachment mechanism disclosed hereinabove for any of the shims disclosed hereinabove such as, for example, the shims 330, 340430, 530 and 630. Any other suitable attachment mechanism may also be used for attaching the shim 100 to the first ICI-part 700.

[0344] There are two different possible embodiments of the shim 100 that may solve the problems of different thickness of calvarial bone 2 in different patients and in different implantation sites on the same skull and the problem of the different anatomical location(s) sizes and positions of the relevant stimulation targets in different individuals.

[0345] In the first embodiment, the shim 100 is used to solve all of the above indicated problems. In such an embodiment the number and / or the configuration and / or the shape and / or the branching pattern of the hollow passages of the shim 100 (including, but not limited to, the hollow passages 100A and 100B) may be modified to adapt the shim 100 to the specific anatomical location(s) of the cortical stimulation target(s) detected and measured in the patient by the imaging methods as disclosed hereinabove. In addition, the shim 100 is made such that the thickness H of the shim 100 is computed from the planned depth Z of the recess 2B within the calvarial bone 2 and from the effective thickness T of the two-part ICI 900, such that H=Z-T. This ensures that when the assembly including the two-part ICI 900 and the attached shim 100 is implanted within the recess 2B and is attached to the outer surface 2A of the calvarial bone 2 by the bone screws 85 A and 85B, the second side 102B of the shim 100 is in contact with at least part of the bottom surface 2C of the recess 2B or is very close to the bottom surface 2C. This arrangement advantageously keeps the openings of any of the hollow passages on the second side 102B of the shim 100 at the closest possible distance (within the limitations of the depth Z of the recess 2B and the error margin of the method used to form the recess 2B within the calvarial bone 2) to reduce and / or minimize the currents required for cortical target stimulation. Taking into account the typical errors in drilling / milling of the recess 2B and irregularities and the slight curvature of the outer surface 2A of the calvarial bone 2, the distance between the second surface 102A and the bottom surface 2C the recess 2B should preferably be less than 1-2 millimeter.

[0346] The above disclosed first embodiment of the shim 100 is usable with a type of two-part ICI in which the combined thickness T of the two-part ICI 900 is standardized and does not vary. In such an embodiment the effective thickness K of the first ICI-part 700 is fixed (standardized) and does not vary in different patients. The effective thickness S of the second ICI-part 800 is also fixed (standardized) and does not vary in different patients. The advantages of this embodiment are that it is logistically easier and less expensive to manufacture and stock the standard sized forms of the first ICI-part 700 and the second ICI-part 800 and vary only the effective thickness H of the shim 100 for each individual patient since it would be much cheaper to manufacture for each patient only the shim 100 than to individually vary S and / or K for each patient.

[0347] In a second embodiment of the shim 100, the shim 100 is used only for solving the problem of variability of the different anatomical location(s) sizes and positions of the relevant stimulation targets in different individuals. In this embodiment the effective thickness H of the shim 100 is fixed (standardized), the thickness K of the first ICI-part 700 is also fixed (standardized) and only the passages of the shim 100 (either hollow passages or passages filled with an electrically conducting material) are adapted to an individual patient based on the potential stimulation targets detected and anatomically and functionally localized by using the imaging methods as disclosed hereinabove. In this embodiment the problem of the varying thickness of the calvarial bone 2 is solved by varying the effective thickness S of the second ICI-part 800.

[0348] After determining the total thickness Y of the calvarial bone 2 at the desired site of implantation (using the imaging methods disclosed hereinabove) of a specific patient and deciding what is the desired depth Z of the recess 2B, the effective thickness S of the second ICI-part 800 may be computed or calculated as S=Z-(K+H). A suitable second ICI-part 800 may then be selected from a stock of such second ICI-parts having different values of S, or alternatively, the second ICI-part 800 may be specifically made for this patient by using a housing 814 that is manufactured to have a thickness K and manufacturing a spacer 807 that has a thickness that suitably fills the space between the lid 812 and the induction coil 809. The second ICI-part 800 may then be assembled from all the standard parts including the magnet 805, the lid 812, and induction coil 809 coil assemble and the specifically adapted parts including the housing 814 and the spacer 807 that has been manufactured to result in a second ICI-part 800 having the calculated effective thickness S. The second embodiment is somewhat more complicated and possibly more expensive than the first embodiment because it involves custom manufacturing of two or three parts (the shim 100, the second ICI-part 800 and optionally the spacer 807) while only the first ICI-part 700 is standardized (has a standard effective thickness K). However, the second embodiment may still be practical if a 3D printing method is used to print the two or three necessary custom-made parts.

[0349] It is noted that the use of the first and second embodiments of the shim 100 (and the custom made second ICI-part 800 having a customized thickness S disclosed hereinabove is not limited to use in cases in which the implantation recess 2B does not breach the calvarial bone 2 but may also be usable when the calvarial bone 2 is breached in a way similar to the way illustrated in FIG. 7.

[0350] Turning to FIG. 37, The shim 120 is identical to the shim 120 of FIG. 7. The Two-part ICI 900 is identical to the two-part ICI 900 of FIG. 36 and the first ICI-part 700 and the second ICI- part 800 are identical to the first ICI-part 700 and the second ICI-part 800, respectively.

[0351] The shim 120 may be attached to the first ICI-part 700 using any of the attachment methods and / or attachment mechanisms disclosed hereinabove with respect to FIG. 36. The implantation method is different than the implantation method illustrated in FIG. 36. During the implantation of the assembly including the two-part ICI 900 and the shim 120 attached thereto, a through-hole 2F is formed (for example, by drilling, milling or by any other suitable surgical method). The hole 2F passes through the entire thickness W of the calvarial bone 2. The assembly of the two-part ICI 900 and the shim 120 attached thereto is inserted through the hole 2F and the side-tabs 812A and 812B are attached to the outer surface 2A of the calvarial bone 2 by screwing the screws 85A and 85B through the holes 812C and 812D, respectively, into the calvarial bone 2. The assembled two-part ICI 900 and shim 120 extends through the CSF 3 and the second side 122C of the shim body 122 may touch or may be positioned in very close vicinity of the surface 4A of the dura matter layer 4 overlying the cortex 6. It is noted that the thin pia matter layer attached to the cortex 6 is not shown in FIGS. 36 and 37.

[0352] It is noted that the effective thickness of the shim 120 is labeled H for designation purposes, even though the actual value of the effective thickness H of FIG. 36 may be larger than or smaller than the effective thickness H of the shim 100 of FIG. 37, depending, inter alia on the exact thickness of the calvarial bone 2 at the site of implantation and on the distance between the inner surface 2C of the calvarial bone and the selected target tissue (which may be the outer surface 4 A of the matter 4 or a portion of the arachnoid matter 5 or the outer surface of the pia matter (not shown in FIG. 37), or the surface of the cortex 6. When the shim 120 is designed for a specific patient and skull location, the thickness H of the shim 120 is made such that HR - T, where R is the distance between the surface 4 A of the dura matter 4 and the outer surface 2A of the calvarial bone 2, and T is the effective thickness of the two-part ICI 900. This ensures that when the second ICI-part 800 is attached to the outer surface 2A of the calvarial bone 2 (by using the bone screws 85 A and 85B), the second surface 122C of the shim body 122 touches at least part of the surface 4 A of the dura matter 4 or is positioned in the vicinity of the surface 4A of the dura matter 4.

[0353] The value of R may be determined by one or more imaging methods performed for each specific patient, such as, for example, MRI, fMRI, CT, or combinations of such methods, as disclosed in detail hereinabove. Since the effective thickness T of the two-part ICI 900 is known, after R is determined, the desired effective thickness H of the shim 120 may be calculated as H=R- T. Thus, the shim 120 may be individually adapted (and individually made) for each specific patient (taking into account the specific implantation site on the skull of the patient), solving the problem of the individual differences in individual patients and different implantation sites.

[0354] There are two different possible embodiments of the shim 120 that may solve the problems of different thickness of calvarial bone 2 in different patients and in different implantation sites on the same skull and the problem of the different anatomical location(s) sizes and positions of the relevant stimulation targets in different individuals.

[0355] In the first embodiment, the shim 120 is used to solve all of the above indicated problems. In such an embodiment the number and / or the configuration and / or the shape and / or the branching pattern of the hollow passages of the shim 100 (including, but not limited to, the hollow passages 120A and 120B) may be modified to adapt the shim 120 to the specific anatomical location(s) of the cortical stimulation target(s) detected and measured in the patient by the imaging methods as disclosed hereinabove. In addition, the shim 120 may be made such that the effective thickness H of the shim 120 is computed or calculated from the measured distance R and from the effective thickness T of the two-part ICI 900, such that H=R-T. This ensures that when the assembly including the two-part ICI 900 and the attached shim 120 is implanted and is attached to the outer surface 2A of the calvarial bone 2 by the bone screws 85A and 85B, the second side 122B of the shim body 122 is in contact with at least part of the surface 4A of the dura matter 4 or is positioned very close to the surface 4A. This arrangement advantageously keeps the openings of any of the hollow passages on the second side 122C of the shim 120 close to the surface 4A to reduce and / or minimize the currents required for cortical target stimulation. If the surface of the pia (not shown) is exposed during surgery, the above indicated calculation based on the imaging results measurements will result in the second side 122B of the shim body 122 being in contact with at least part of the surface of the pia (not shown in Fig. 37) or being positioned very close to the surface of the pia after implantation.

[0356] The above disclosed first embodiment of the shim 120 is usable with a type of two-part ICI in which the effective thickness T of the two-part ICI 900 is standardized and does not vary. In such an embodiment the thickness K of the first ICI-part 700 is fixed (standardized) and does not vary in different patients. The effective thickness S of the second ICI-part 800 is also fixed (standardized) and does not vary in different patients. The advantages of this embodiment are that it is logistically easier and less expensive to manufacture and stock the standard sized forms of the first ICI-part 700 and the second ICI-part 800 and vary only the effective thickness H of the shim 120 for each individual patient since the shim 120 would be much less expensive to manufacture for each patient.

[0357] In a second embodiment of the shim 120, the shim 120 is used only for solving the problem of variability of the different anatomical location(s) sizes and positions of the relevant stimulation targets in different individuals. In this embodiment the effective thickness H of the shim 120 is fixed (standardized), the thickness K of the first ICI-part 700 is also fixed (standardized) and only the parameters of the passages of the shim 100 (either hollow passages or passages filled with an electrically conducting material) are adapted to an individual patient based on the potential stimulation targets detected and anatomically localized by using the imaging methods as disclosed hereinabove. Such passage parameters may include, inter alia, the shape and size of one or more of the passages, the cross-sectional area of the passage(s), the degree of branching of the passage(s), the cross-sectional shape and cross-sectional area of any of the openings of thew passage(s)). In this embodiment the problem of the varying thickness of the calvarial bone 2 is solved by varying the thickness S of the second of the second ICI-part 800. After determining the distance W between the outer surface 2A of the calvarial bone 2 and the outer surface 4A of the dura matter 4 at the desired site of implantation (using the imaging methods disclosed hereinabove), the thickness S of the second ICI-part 800 may be computed or calculated as S=W- (K+H). A suitable second ICI-part 800 may then be selected from a stock of such second ICI- parts having different values of S, or, alternatively, the second ICI-part 800 may be specifically made for this patient by using a housing 814 that is manufactured to have an effective thickness S and manufacturing a spacer 807 that has a thickness that suitably fills the space between the lid 812 and the induction coil 809. The second ICI-part 800 may then be assembled from all the standard parts including the magnet 805, the lid 812, and induction coil 809 coil and the specifically adapted parts including the housing 814 and the spacer 807 that has been manufactured, to result in a second ICI-part 800 having the calculated effective thickness S. The second embodiment is somewhat more complicated and possibly more expensive than the first embodiment because it involves custom manufacturing of two or three parts (the shim 120, the second ICI-part 800 and optionally the spacer 807) while only the effective thickness K of the first ICI-part 700 is standardized. However, the second embodiment may still be practical if 3D printing is used to print the two or three necessary custom-made parts.

[0358] It will be appreciated by those skilled in the art that in some embodiments of the implantation method, it may also be possible to remove part of the layer of dura matter 4 and the arachnoid matter 5 to expose the thin pia matter layer (not shown in FIG. 37 due to its thinness) overlying the cortex 6. In such cases when the second implantation method is being used, the effective thickness S of the second ICI-part 800 may be calculated as follows:

[0359] S = (the distance between the surface 2A of the calvarial bone 2 to the surface of the pia matter at the desired site of implantation) minus (K+H).

[0360] It is noted that while the passages of the shims 100 and 120 (such as, for example, the passages 100A and 100B of the shim 100 and the passages 122 A and 122B of the shim 120) are illustrated as hollow passages, this is not obligatory, and any of the passages included in the shims 100 and 120 may be implemented as passages filled with any of the solid or semi-solid or hydrogel based electrically conducting materials disclosed hereinabove.

[0361] Furthermore, while the exemplary shims (and / or the ICIs) of the present application are illustrated as having a cylindrical shape and a circular transversal cross-section, this is not obligatory, and other embodiments of such shims and / or ICIs may be used. For example, the shims of the present application may have a square or rectangular transversal cross-section or an ellipsoidal transversal cross-section, or any other desired suitable type of transversal cross-section (a transversal cross-section means herein a cross-section taken in a plane parallel to the plane of the second surface of the second shim-side of the shim (such as, for example, the second surface 22B of the second shim- side 2 IB of FIG. 3, the second surface 102D of the second shim- side 101B of the shim body 102 of FIG. 6, the second surface 122C of the second shim-side 121B of FIG. 7, the second surface 222C of the second shim-side 201B of the shim body 200 of FIG. 12, the second surface 232C of the second shim-side 23 IB of the shim body 232 of FIG. 13, the second surface 242C of the second shim-side 24 IB of the shim body 242 of FIG. 14 , the second surface 252C of the second shim-side 25 IB of the shim body 252 of FIG. 15, the second surface 262C of the second shim-side 261B of the shim body 262 of FIG. 16, the second surface 282C of the second shim-side 28 IB of the shim body 282 of FIG. 18, the second surface 302C of the second shim-side 301B of the shim body 302 of FIG. 21, the second surface 342C of the second shimside 341B of the shim body 342 of FIG. 22 , the second side 432C of the second shim-side 43 IB of the shim body 432 of FIG, 23, the second surface 532C of the second shim-side 53 IB of the shim body 532 of FIG. 27, the second surface 632C of the second shim-side 63 IB of the shim body 632 of FIG. 31 and the second surface 652C of the second shim-side 65 IB of the shim body 652 od FIG. 35).

[0362] Such shims having a non-circular transversal cross-section may not use all the attachment mechanisms and methods disclosed hereinabove but only some of the attachment mechanisms. For example, the attachment mechanism including a female or male threaded parts of FIGS. 21 and 22, respectively cannot be used for a shim that has a non-circular transversal cross-section. However, if the shim is slightly modified, such threaded portions may also be used. For example, if the shim body 302 (of FIG. 21) is modified to have a square transversal cross-section, the threaded part 302A may still have a female threaded circular transversal cross-section and the ICI 190 may be modified to have a square cross-section and the male threaded part 180C may be modified to have a circular cross-section. A similar modification may be applied to the transversal cross-sectional shape of the shim body 342 of shim 340 and to the ICI 310 of FIG. 22.

[0363] If the transversal cross-section of a shim is non-circular, the cross-sectional shape of the hole or recess made in the calvarial bone 2 may have to be modified to match the cross-sectional shape of the shim and ICI. For example, if the shim body 302 has a square transversal cross-section, the recess or through hole made in the calvarial bone 2 should also have a square cross-section. While such non-circular recesses or holes cannot usually be made by drilling, they may be made using suitable surgical milling methods.

[0364] It is noted that while all the ICIs disclosed and illustrated hereinabove have several stimulating electrodes on the first side of the ICI, this is not obligatory. In accordance with some embodiments, The ICI may have a single large stimulating electrode on the first side of the ICI.

[0365] Reference is now made to FIG. 38 which is a schematic cross-sectional view of an ICI having a single stimulating electrode and a current return electrode attached to a compatible shim, in accordance with an embodiment of the ICIs and shims of the present application.

[0366] The ICI 1000 has a first ICI-side 1001A and a second ICI-side 1001B. The ICI 1000 may include a housing 1014 having a first surface 1014A and a lid 1012 that may be screwed into the housing 1014 to hermetically seal the housing 1014. The lid 1012 may have an external surface 1012A and two side-tabs 1084A and 1084B. the side-tabs 1084A and 1084B have holes 1084C and 1084D formed therein, respectively. The side-tabs 1084A and 1084B may be used for attaching the ICI 1000 to the external surface of the calvarial bone (not shown in FIG. 38) using suitable bone screws (not shown in FIG. 38) as disclosed in detail hereinabove for the ICI 80 of FIG. 8. The effective thickness of the ICI 1000 is B. The ICI 1000 may also include a single stimulating electrode 1008 A and an annular current-return electrode 1008F. The stimulating electrode 1008A may be partially embedded in or attached to the first surface 1014A of the first ICI-side 1001A as illustrated in FIG. 38. The current return electrode 1008F may be attached to or partially embedded in the side 1014B of the housing 1014. The ICI 1000 may or may not include sensing / recording electrodes.

[0367] In embodiments of the ICI 1000 that include sensing / recording electrodes (not shown in the cross-sectional view of FIG. 38) the sensing / recording electrodes may be implemented in a way similar to the arrangement of the electrodes 65A-65D of the ICI60 (of FIG. 10, but any other suitable number and arrangement of such sensing / recording electrodes may be used.

[0368] The ICI 1000 includes an electronics module 1006 that is hermetically sealed within the ICI 1000. The electronics module may include energy harvesting circuits (not shown), and all the necessary circuitry for controlling the application of a voltage difference between the stimulating electrode 1008 A and the current return electrode 1008F. In embodiments including sensing / recording electrodes (not Shown in FIG. 38 for the sake of clarity of illustration), the electronics module 1006 may also include all the circuitry necessary to sense and / or record cortical signals from the cortex, as well as circuitry for communicating with external devices such circuitry is disclosed in detail in international publications WO2019 / 130248, WO2019 / 244099, WG2020 / 050527, WO2020 / 161555 WO2021 / 144730 and WG2018 / 109715, and are therefore not described in detail in the present application.

[0369] The shim 1100 has a first shim-side 1101A and a second shim-side 1101B opposing the first shim-side 1101A. The shim 1100 has a shim body 1102 having a first surface 1102A attachable to the first surface 1014A of the first ICI-side 1001A of the ICI 1000 and a second surface 1102B. The shim 1100 has an effective thickness H20. The shim 1100 is shown in FIG. 38 as attached to the ICI 1000 using a suitable adhesive as disclosed in detail hereinabove for the ICI 10 and the shim 20 of FIGS. 3-4). It is noted that the layer of adhesive applied between the first surface 1014A and the first surface 1102 A of the first shim- side 1101 A of the shim body 1102 is not shown in FIG. 38 for the sake of clarity of illustration. The shim 1100 has a bifurcating hollow passage 1115 passing through the shim body 1102. The hollow passage 1115 has two openings 1115A and 1115B opening on the second surface 1102B of the shim body 1102 and a single opening 1115C opening on the first surface 1102A of the shim body 1102. The opening 1115C circumscribes the stimulating electrode 1008 A.

[0370] While the arrangement of the stimulating electrode 1008 A and the current return electrode 1008F may not allow the use of current steering methods such as the current steering methods described in international published application WO 2021 / 144730, controlling the current density distribution under the second surfacel 102B of the shim body 1102 may still be possible by suitably changing the number and / or shape and / or cross-sectional area and / or position of the openings (such as, for example, the openingsl l l5A and 1115B) on the second surface 1102B of the shim body 1102. The parameters of these openings may be determined by the anatomical and functional imaging methods (such as, for example, CT MRI and fMRI) as disclosed in detail hereinabove.

[0371] The effective thickness H20 of the shim 1100 may be determined by using the same calculations disclosed hereinabove with respect to the ICI 80 and the shim 100 of FIG. 6, wherein the effective thickness B of the ICI 1000 is a known standardized thickness, and the distance between the top surface of the calvarial bone to the bottom surface of the planned recess in the calvarial bone are known (for the calvarial bone recess implantation method illustrated in FIG. 6). Similarly, for the implantation method using breaching of the calvarial bone 2, the effective thickness H20 of the shim 1100 may be calculated using the method described with respect to the ICI 80 and the shim 120 of FIG. 7. It is noted that the effective thickness of the ICI 1000 is B which does not include the thickness ST of the side-tabs 1084A and 1084B.

[0372] While the use of a single large stimulating electrode in an ICI sacrifices the possibility for using current steering methods to control the current density distribution under the shim, it has the advantage of greatly simplifying the design and operation of the electronic circuitry module 1006 because it eliminates the need to use multiple current or voltage amplifiers required to control the application of different voltages to multiple stimulating electrodes which may significantly reduce the cost of the ICI 1000. Moreover, the use of a single stimulating electrode having a relatively large surface area may improve the ability to deliver higher stimulating currents to the cortical target regions (as compared to using several stimulating electrodes each having a smaller surface area.

[0373] It is noted that if it is determined (for example, by the use of fMRI of the patient) that the relevant cortical (or non-cortical) stimulation target regions have changed or shifted in position and / or distribution, this may be addressed by surgically removing the ICI 1000 and shim 1100 from the implantation site, detaching the shim 1100 from the ICI 1000 (using a suitable detaching method), reattaching a new shim (designed specifically to address the shift of the target cortical regions(by changing the number and / or shape and / or location and / or cross-sectional area of one or more of the openings on the second surface 1102B of the shim 1100) to the ICI 1000 and reimplanting the ICI 1000 and the new shim attached thereto) in the same recess or through hole in the calvarial bone 2.

[0374] The detaching of the shim 1100 from the ICI 1000 may be performed by dissolving the adhesive attaching the shim 1100 to the ICI 1000 by using any suitable solvent that may dissolve the adhesive. However, in some embodiments, the attachment of the shim to the ICI may be performed by using any suitable type of attaching mechanism disclosed hereinabove with respect to the shims and ICIs illustrated in FIGS. 21-32, which may require modifying the structure of the ICI 1000 and the shim 1100 to include the required parts of the attaching mechanism. In such embodiments using such attaching mechanisms the detaching of the shim from the ICI is simpler, does not require the use of a solvent and may be performed as disclosed in detail hereinabove with respect to the ICIs and shims illustrated in FIG. 21-32.

[0375] It is noted that while the exemplary shim 1100 of FIG. 38 includes a hollow bifurcating passage, in other embodiments the shim may include a passage filled with an electrically conducting material (solid or semi-solid or gel-like) as disclosed in detail in FIGS. 8-9 hereinabove or with an electrically conducting contact mechanism similar to the contact mechanisms disclosed in FIGS. 40-48 hereinafter.

[0376] It is also noted that while the exemplary hollow passage 1115 of the shim 1100 is a bifurcating passage, this is not obligatory, and the passage (either a hollow passage or a filled passage) may have any suitable number of branches reaching the second surface 1102B of the shim body 1102, depending, inter alia, on the size and / or location of the cortical regions or subregions that need to be stimulated.

[0377] It is noted that in embodiments in which the passages are filled with an electrically conducting material it may be necessary to ensure firm electrical contact between the surface of the stimulating electrode(s) and the electrically conducting material filling the passage(s) formed within the shim body. For passages filled with an electrically conducting gel or hydrogel, this may be achieved by attaching the shim to the ICI and then inverting the resulting assembly such that the opening(s) on the second surface of the shim face upwards. For example, after attaching the shim 150 to the ICI 80 (of FIG. 9), the surface 82A of the lid 82 may be places on a flat levelled surface (such as the surface of a stable work-table) and a liquid including suitable monomers or cross -linkable polymers or a solution including the precursors for an electrically conducting gel or hydrogel may be poured carefully into the passages 152A and 152B until they are full and then allowing the liquid or solution to polymerize or cross-link or inducing polymerization or crosslinking by irradiating with ultra-violet light, heating, or any other suitable polymerization and / or cross linking and / or curing method. This method may ensure firm electrical contact between the stimulating electrodes 80A and 80B and the electrically conducting semi- solid or gel-like material 155. However, in embodiments in which the material filling the passages is a metal, or a metallic alloy or any other solid electrically conducting material, it may be necessary to use other methods or structures to ensure a firm electrical contact with the stimulating electrode(s).

[0378] Reference is now made to FIG. 39, which is a schematic cross-sectional view of a shim having passages filled with an electrically conducting solid material, in accordance with an embodiment of the shims of the present application.

[0379] The shim 1050 has a first shim-side 1141 A and a second shim-side 114 IB opposing the first shim-side 1141 A. The shim 1050 may include a shim body 1142 having a first rim surface 1142E and a second surface 1142F. The shim body 1142 has cylindrical passages 1142A and 1142B filled with an electrically conducting material. It is noted that only the two passages 1142A and 1142B are seen in the cross-sectional view of FIG. 39. The shim body 1142 has a rim 1142C that has a female threaded part 1142B. The rim 1142C surrounds a recessed portion of the shim body 1142 having a bottom-surface 1142D. The shim 1050 may also include a perforated sealing gasket 1140 having multiple perforations therein. It is noted that only two perforations 1140A and 1140B may be seen in the cross-sectional view of FIG. 39. The perforated sealing gasket 1140 may be made from an elastic compressible material, such that it may be highly compressed by attaching a compatible ICI (not shown) to the shim 1050. The effective thickness H17 of the shim body 1142 includes the thickness of the rim 1142C. However, the thickness of the (compressed) perforated gasket 1140 need not be taken into account because the perforated gasket 1140 may be made thin enough to be negligible in comparison to the combined effective thickness of the shim 1050 and the ICI (not shown) that may be attached to the shim 1050 prior to implantation.

[0380] Multiple electrically conducting cylindrically shaped solid members are attached within the multiple passages of the shim body 1142. However only the two electrically conducting cylindrically shaped solid members 1145 and 1146 may be seen in the cross-sectional view of FIG. 39. The electrically conducting, cylindrically shaped solid members (such as, for example, the cylindrically shaped solid members 1145 and 1146) may be made from any electrically- conducting, biocompatible material such as, for example, gold, platinum, gold plated copper, a platinum-iridium alloy, a solid electrically conducting polymer, or any other biocompatible electrically conducting solid material. The solid members 1145 and 1146 (as well as any of the other cylindrically shaped electrically conducting members included in the shim body 1142) have a thickness H16. The solid members 1145 and 1146 (as well as any of the other cylindrically shaped electrically conducting members included in the shim body 1142) may be firmly attached within the passages 1142A and 1142B (or within the other passages not seen in the cross-sectional view of FIG. 39), respectively, by a suitable biocompatible adhesive. The cylindrically shaped solid member 1145 has a first circular surface 1145A protruding from the bottom surface 1142D of the shim body 1142. The circular surface 1145A is lower than the upper surface 1140C of the perforated sealing gasket 1140 and is circumscribed by the perforation 1140A of the gasket 1140. The solid member 1145 has a second circular surface 1145B that may be flush with the second surface 1142F of the shim body 1142 (However, in some embodiments the second circular surface 1145B may slightly protrude from the second surface 1142F).

[0381] The cylindrically shaped solid member 1146 has a first circular surface 1146A protruding from the bottom surface 1142D of the shim body 1142. The first circular surface 1146A is lower than the upper surface 1140C of the perforated gasket 1140 and is circumscribed by the perforation 1140B of the gasket 1140. The solid member 1146 has a second circular surface 1146B that may be flush with the second surface 1142F of the shim body 1142. (However, in some embodiments the second circular surface 1146B may slightly protrude from the second surface 1142F). When the shim 1050 is attached to an ICI such as, for example, the ICI 190 (of FIG. 21) by screwing the male threaded protruding portion 180C of the ICI 180 into the female threaded part 1142B of the shim 1142, the perforated gasket 1140 may be compressed until the first and the second circular surfaces 1145A and 1146A, respectively, are firmly in contact with the stimulating electrodes 180A and 180B of the ICI 180. Any other cylindrically shaped solid members included in the shim body 1142 but not shown in the cross-sectional view of FIG. 39 may firmly contact the rest of the stimulating (and any sensing / recording electrodes) that may be included in the ICI 190 due to the force generated by the screwing of the ICI 190 into the shim body 1142.

[0382] To ensure proper alignment of such solid members (with the corresponding stimulating and sensing / recording electrodes, the shim 1050 and the ICI 190 may include alignment markers similar to the alignment markers 35 and 36 of the shim 20 and the ICI 10, respectively, of FIGS. 4-5. If the perforated gasket 1140 is made from a highly compressible material, the thickness of the compressed gasket 1140 may be negligible as compared to the combined thickness H17 of the shim 1140 and the effective thickness B of the ICI 190 such that the total thickness of the assembled shim 1140 and the ICI 190 is practically nearly equal to H17+B.

[0383] Other methods and mechanisms for ensuring good electrical contact between the stimulating and / or sensing / recording electrodes of an ICI with any solid material filling the passage(s) included in a shim may be used.

[0384] Reference is now made to FIG. 40, which is a schematic cross-sectional view illustrating a shim including spring-loaded electrical contact mechanisms, in accordance with an embodiment of the shims of the shims of the present application. The shim 1200 has a first shim-side 1201A and a second shim-side 1201B opposing the first shim-side 1201 A. The shim 1200 may include a cylindrical shim body 1202 having a cylindrically shaped male threaded protruding portion 1202E, a first surface 1205F of the first shim- side 1201 A and a second surface 1205C of the second shim-side 1201B. The shim 1200 may also include a thin perforated sealing gasket 1240 having multiple circular perforations therein. For example, the circular perforations 1240A and 1240B may be seen in the cross-sectional view of FIG. 40 (any other perforations within the perforated gasket 1240 are not shown in the cross-sectional view of FIG. 40). In some embodiments, the perforated sealing gasket 1240 may be attached to the first surface 1

[0385] The shim 1200 may include multiple cylindrically shaped passages passing therethrough. For example, the passages 1202A and 1202B may be seen in the cross-sectional view of FIG. 40 (any other passages included in the shim 1200 are not shown in the cross-sectional view of FIG. 40). The passage 1202A includes a spring-loaded electrical contact mechanism 1205 sealingly attached therewithin (such as, for example, by a suitable biocompatible adhesive, not shown in FIG. 40 for the sake of clarity of illustration). The contact mechanism 1205 includes a cylindrical housing 1205C having a circular opening 1205E formed therein. The contact mechanism 1205 also includes a contact pin 1205A slidably disposed within the circular opening 1205E, a folded (or zig-zag shaped) spring 1205B and a male threaded end-plug 1205D. The contact mechanism 1205 may be circumscribed by the perforation 1240A of the perforated sealing gasket 1240.

[0386] The passage 1202B includes a spring-loaded electrical contact mechanism 1206 attached therewithin. The contact mechanism 1206 may be similar to the contact mechanism 1205 and includes a cylindrical housing 1206C having a circular opening 1206E formed therein. The contact mechanism 1206 also includes a contact pin 1206 A, a folded (or zig-zag shaped) spring 1206B and a male threaded end-plug 1206D. Additional contact mechanisms may be included in additional passages formed within the shim body 1202. Such additional passages and contact mechanisms cannot be seen in the cross-sectional view of FIG. 40. The contact mechanism 1206 may be circumscribed by the perforation 1240B of the perforated sealing gasket 1240.

[0387] In some embodiments, the housing 1205, the contact pin 1205A, the spring 1205B and the end plug 1205D may all be made from an electrically conductive material such as, for example, a metal (or metallic alloy) like stainless steel, gold-coated or gold-plated stainless steel, gold-coated or gold-plated copper or any other suitable metal or metallic alloy that has good electrical conductivity. One end of the spring 1205 may be soldered to the contact pin 1205A and the other end of the contact pin may be soldered to the end-plug 1205D. The soldering may be hot soldering or cold soldering using a high electrical conductivity epoxy resin or any other electrically conductive strong adhesive material. In such an embodiment, the entire contact mechanism may conduct electricity.

[0388] In some other embodiments of the contact mechanism 1205, the housing 1205A may be made from any suitable electrically isolating material, (such as, for example, a ceramic material, a strong machinable polymer-based material such as, for example, medical grade PMMA, PET, PEEK, PP or any other suitable biocompatible electrically isolating polymer-based material) while the contact pin 1205A, the spring 1205B and the end plug 1205D (that are soldered together as described above) are made from any of the electrically conducting materials disclosed hereinabove. In such an embodiment of the contact mechanism 1205, the contact pin 1205A is electrically connected to the end-plug 1205D by the electrically conducting spring 1205B.

[0389] When the shim 1200 is attached to a compatible ICI (such as, for example, the ICI 310 of FIG. 22) by screwing the male threaded part 1202E of the shim 1200 into the compatible female threaded part of a compatible ICI (such as, for example, the female threaded recess 310D of the ICI 310), the contact pins of the contact mechanisms of the shim 1200 (such as, for example, the contact pins 1205A and 1206A of the contact mechanisms 1205 and 1206, respectively) are gradually pushed into the housings of the contact mechanism (such as, for example, the housings 1205C and 1206C, respectively) compressing the springs of the contact mechanisms (such as, for example, the springs 1205B and 1206B, respectively).

[0390] Once the shim 1200 is screwed in all the way or almost all the way into the ICI (such as, for example, the ICI 310) and properly aligned (for example, by aligning suitable alignment markers included in the ICI and the shim (see, for example, the alignment markers 35 and 36 of FIGS. 3- 4), the contact pins 1205A and 1206A are in firm electrical contact with the corresponding stimulating electrodes of the ICI (such, as, for example, the stimulating electrodes 310A and 310B, respectively) due to the force exerted by the compressed springs (such as, for example, the springs 1205B and 1206B) on the contact pins 1205A and 1206A, respectively, pushing the contact pins 1205A and 1206A against the corresponding stimulating electrodes (such as, for example, the stimulating electrodes 310A and 310B, respectively of the ICI 310).

[0391] The effective thickness H18 of the shim 1200 may be determined as disclosed hereinabove for the other shims using data obtained from the anatomical imaging methods and the known standardized effective thickness B of the ICI being used as disclosed in detail hereinabove. When a voltage difference is applied between a stimulating electrode and a current return electrode (for example, between the stimulating electrode 310A and the current return electrode 31 OF of the ICI 310) an electrical current will flow from the stimulating electrode 310A through the contact pin 1205A and the spring 1205B and exit through the end-plug 1205D into the cortical tissue underlying the end-plug 1205D returning into the current return electrode (such as, for example, the current return electrode 31 OF of the ICI 310).

[0392] It is noted that in some embodiments, the calculated value H18 of the effective thickness of the shim 1200 may be used to calculate the height of the housings of the contact mechanisms of the shim 1200 (such as, for example, the housings 1205C and 1206C of the contact mechanisms 1205 and 1206, respectively by using the formula H19 = H18+TP, where TP is the thickness of the threaded part 1202E of the shim 1200. TP is a known value because it is standardized to match the standardized height of the female threaded part of the ICI being attached to the shim 1200 (such as, for example, the female threaded recess 310D of the ICI 310). This calculation may be used to ensure that the surface of the side 1205F of the housing 1205 of the contact mechanism 1205 is flush with the first surface 1202D of the first shim-side 1201A and the surface of the side 1206F of the housing 1206 of the contact mechanism 1206 is also flush with the surface 1202C of the second shim- side 120 IB of the shim 1200.

[0393] It is noted that in some embodiments of the shims of the present application, such as, for example, shims having bifurcating or other types of branching passages, it may be necessary to modify the structure of the contact mechanism as is described hereinafter.

[0394] Reference is now made to FIG. 41-45. FIG. 41 is a schematic bottom view of an ICI attachable to the shim illustrated in FIGS. 43-45. FIG. 42 is a schematic cross-sectional view of the ICI of FIG. 41, taken along the lines XLII-XLII. FIG. 43 top view of a shim including four hollow passages and four passages including spring loaded electrical contact mechanisms, in accordance with an embodiment of the shims of the present application. FIG. 44 is a schematic cross-sectional view of the shim of FIG. 43, taken along the lines XLIV-XLIV. FIG. 45 is a schematic bottom view of the shim of FIG. 43.

[0395] Turning to FIGS. 41 and 42, the ICI 1300 has a first ICI-side 1301A and a second ICI-side 1301B opposite the first ICI-side 1301 A. The ICI 1300 may include a housing 1314 and a lid 1312 that may hermetically seal the housing 1314 using a threaded lid portion 1312A that may be screwed into a compatible threaded part 1314A of the housing 1314. The surface 1312E of the lid 1312 is positioned on the second ICI-side 1301B. The lid 1312 may include two side-tabs 1304A and 1304B having holes 1304C and 1304D formed therein for attaching the ICI 1300 to the outer surface of the calvarial bone (not shown in FIG. 42) using two bone screws (not shown) as disclosed in detail hereinabove with respect to the ICI 80 of FIG. 6. The ICI 1300 may also include a perforated sealing gasket 1340. In some embodiments of the ICI 1300, the perforated sealing gasket 1340 may be attached to the first surface 1314C of the ICI 1300 by a suitable adhesive. The housing 1314 has a diameter D13 and has a cylindrically shaped portion 1314B having a diameter D14 wherein D13>D14. The cylindrically shaped portion 1314B may be male threaded. The effective thickness of the ICI 1300 is B. It is noted that the thickness BT of the male threaded portion 1314B is not included in the effective thickness B, because when the ICI 1300 is attached to the compatible shim 1350 (of FIG.44 below), the threaded portion 1314B is fully screwed into the female threaded portion 1353A of the rim 1353 of the shim 1350 and therefore does not contribute to the total thickness of the assembly including the ICI 1300 and the shim 1350. It is also noted that the thickness TG of the perforated gasket 1340 is also assumed to be negligible in comparison to the total thickness of the ICI 1300 and the shim 1300 when they are assembled together ((H20 + B) » TG).

[0396] The ICI 1300 includes an electronics module 1306 similar to the electronics module 522 of FIG. 29. The ICI 1300 includes four stimulating electrodes 13O8A-13O8D partially embedded in or attached to a first surface 1314C of the first ICI-side 1301 A. The ICI 1300 also includes an annular current return electrode 1008F partially embedded in or attached to a third surface 1314D of the ICI 1300. The ICI 1300 also includes four sensing / recording electrodes 1040E, 1040F, 1040G and 1040H partially embedded in or attached to the first surface 1314C of the ICI 1300. The four stimulating electrodes 13O8A-13O8D, the annular current return electrode 1008F and the four sensing / recording electrodes 1040E, 1040F, 1040G and 1040H are all suitably electrically connected to the electronics module 1306 and may be used for stimulation of cortical target tissues and for sensing / recording cortical electrical signals of after implantation of the ICI 1300.

[0397] The ICI 1300 also includes a perforated gasket 1340 that has multiple perforations formed therein. The circular shaped perforations 1340A-1340D circumscribe the stimulating electrodes 13O8A-13O8D, respectively, as may be better seen in the cross-sectional view of FIG. 42 for the stimulating electrodes 1308 A and 13O8B. The perforated gasket 1340 may be attached to a first surface 1314C of the ICI 1300 by a suitable biocompatible electrically isolating adhesive, such that after attaching the shim 1350 (of FIGS. 43-44), no liquid can penetrate laterally through the parts of the gasket 1340 that may be attached by the adhesive to the first surface 1314C of the ICI 1300. The perforated gasket 1340 also includes four circular perforations 13401, 1340J, 1340K and 1340L that circumscribe the four sensing recording electrodes 1040E, 1040F, 1040G and 1040H, respectively.

[0398] Turning to FIGS. 43-45, the shim 1350 is detachably attachable to the ICI 1300. The shim 1350 has a first shim-side 1351 A and a second shim-side 135 IB. The shim 1350 includes a cylindrically shaped shim body 1352. The shim body 1352 has a first (annular) surface 1352A positioned on the first shim-side 1351 A and a second surface 1352B positioned on the second shim-side 135 IB. The shim body 1352 has an effective thickness H20 and a diameter D13 that is equal to the diameter D13 of the ICI 1300 (of FIG. 42). The shim body 1352 has a rim 1353 surrounding a cylindrically shaped female threaded recess 1353A having a diameter D14 equal to the diameter D14 of the male threaded portion 1314B of the ICI 1300 (of FIG. 42). The female threaded recess 1353A has a circular bottom surface 1353B. The shim body 1352 has four passages 1044A-1044D formed therein. The shim body 1352 also has four hollow passages 1320, 1321, 1322 and 1323 formed therein. It is noted that only the passages 1044A and 1044C may be seen in the cross-sectional view of FIG. 44. The passage 1044A is a branching passage. The passage 1044C is not branching.

[0399] The hollow passages 1320, 1321, 1322 and 1323 have openings 1320A, 1321A, 1322A and 1323A, respectively, opening at the bottom surface 1353B of the female threaded recess 1353A of the shim bodyl352 (best seen in FIG. 41). The hollow passages 1320, 1321, 1322 and 1323 have openings 1320B, 1321B, 1322B and 1323B, respectively, opening at the second surface 1352B of the shim body 1352 (best seen in FIG. 45).

[0400] A composite contact mechanism 1046A is embedded or attached within the passage 1044A. The composite contact mechanism 1046A includes a spring-loaded contact mechanism 1355, an electrically conducting member 1345 and an electrically conducting connecting member 1359. The spring-loaded contact mechanism 1355 includes a contact pin 1355A slidably disposed within a housing 1355C. An annular threaded member 1355D is screwed into the housing 1355C. The annular threaded member 1355D has an external male threaded surface 1355E that is screwed into a corresponding female threaded part 1355F of the housing 1355C. The annular threaded member 1355D has a circular opening 1355G formed therein. The diameter of the first cylindrically shaped part 1355H is equal to the diameter of the circular opening 1355G The contact pin 1355A has a first cylindrically shaped part 1355H and a second cylindrically shaped part 13551 extending from the first cylindrically shaped part 1355H. The diameter of the first cylindrically shaped part 1355H is equal to the diameter of the circular opening 1355G but is smaller than the diameter of the second cylindrically shaped part 13551. The second cylindrically shaped part 13551 ensures that the contact pin 1355A is retained within the housing 1355C.

[0401] The cylindrically shaped part 1355H of the contact pin 1355 is slidably disposed within the circular opening 1355G. The spring-loaded contact mechanism also includes an electrically conducting spring 1355B. A first side of the electrically conducting spring 1355B is in electrical contact with the contact pin 1355A and a second side of the electrically conducting spring 1355B is in contact with the housing 1355C by being soldered thereto using hot soldering or cold soldering as disclosed in detail hereinabove with respect to FIG. 40. The housing 1355C, the contact pin 1355A and the spring 1355B may be made from any of the electrically conducting materials disclosed hereinabove with respect to the spring-loaded contact mechanisms 1205 and 1206 of FIG. 40. The annular threaded member 1355D may be made from any of the electrically conducting materials disclosed hereinabove with respect to the spring-loaded contact mechanisms 1205 and 1206 of FIG. 40, but in some embodiment may be made from an electrically isolating material, such as, a polymer-based material or a ceramic material.

[0402] The spring-loaded contact mechanism 1355 may be attached to the electrically conducting member 1345 by the electrically conducting connecting member 1359 attached to the housing 1355C and to the surface 1345A of the electrically conducting member 1345. The electrically conducting connecting member 1359 may be a layer of electrically conducting adhesive or an electrically conducting soldering material. For example, soldering tin or any other suitable soldering material may be used for hot soldering the housing 1355C to the electrically conducting member 1345. In some embodiments the connecting member 1359 may be a cold soldering composition, such as, for example, an electrically conducting epoxy resin-based material. The surfaces 1345C and 1345B of the electrically conducting member 1345 may be flush with the second surface 1352B of the shim 1350.

[0403] A composite contact mechanism 1046C is embedded or attached within the passage 1044C. The composite contact mechanism 1046C includes a spring-loaded contact mechanism 1356, an electrically conducting member 1346 and an electrically conducting connecting member 1360. The spring-loaded contact mechanism 1356 is similar in structure and function to the spring-loaded contact mechanism 1355 and includes a contact pin 1356A slidably disposed within a housing 1356C, an annular threaded member 1356D screwed into the housing 1356C and an electrically conducting spring 1356B in electrical contact with the contact pin 1356A and with the housing 1356C by being soldered to the contact pin 1356A and to the housing 1356C using hot soldering or cold soldering as disclosed in detail hereinabove with respect to FIG. 40.

[0404] An annular threaded member 1356D is screwed into the housing 1356C. The annular threaded member 1356D has an external male threaded surface 1356E that is screwed into a corresponding female threaded part 1356F of the housing 1356C. The annular threaded member 1356D has a circular opening 1356G formed therein. The diameter of the first cylindrically shaped part 1356H is equal to the diameter of the circular opening 1356G. The cylindrically shaped part 1356G is slidably disposed within the circular opening 1356G.

[0405] The spring-loaded contact mechanism 1356 may be attached to the electrically conducting member 1346 by the electrically conducting connecting member 1360 attached to the housing 1356C and to the surface 1346A of the electrically conducting member 1346. The electrically conducting connecting member 1360 may be similar to the electrically conducting connecting member 1359. However, the electrically conducting member 1346 is not branched (bifurcating) and has a single surface 1346B that may be flush with the second surface 1352B of the shim 1350.

[0406] The passages 1044B and 1044D have composite contact mechanisms 1046B and 1046D attached therewithin, respectively. It is noted that the passages 1044B and 1044D may be seen in FIG. 43, but cannot be seen in the cross-sectional view of FIG. 44. Each of the composite contact mechanisms 1046B and 1046D includes a spring-loaded contact mechanism 1358 and 1357, respectively, that are identical in structure and function to the spring-loaded contact mechanisms 1355 and 1356.

[0407] Each of the spring-loaded contact mechanisms 1358B and 1358D is attached to a nonbranching electrically conducting member by an electrically conducting connecting member (not shown in FIG. 44) similar to the electrically conducting connecting member 1359 and 1360. It is noted that only the surfaces 1357B and 1358B of the electrically conducting members (not shown in FIG. 44) of the composite contact mechanisms 1046B and 1046D may be seen in the bottom view of FIG. 45.

[0408] When the shim 1350 is attached to the ICI 1300, the male threaded portion 1314B of the ICI 1300 is screwed into the female threaded recess 1353A of the shim 1350 until the perforated gasket 1340 touches the bottom surface 1353B of the recess 1353A. The perforated gasket 1340 may also be compressed during the attachment. During the attachment, the contact pins 1355A, 1356A 1357A and 1358 are pushed by the first surface 1314C of the ICI 1300 into the housings of the respective spring-loaded mechanisms 1355, 1356, 1357 and 1358 (such as, for example, the housings 1355C and 1356C shown in FIG. 44), respectively, compressing the corresponding springs included in the spring-loaded contact mechanisms 1355, 1356, 1357 and 1358, respectively. Once the shim 1350 and the ICI 1300 are properly aligned (for example, by using alignment markers (not shown in FIGS. 41-45) similar to the alignment markers 35 and 36 of the ICI 10 and the shim 20 of FIGS. 4-5), the contact pins 1355A, 1356A, 1357A and 1358A are firmly pushed against the stimulating electrode 1308 A, 13O8C, 13O8D and 13O8B, respectively.

[0409] After alignment is completed the sensing / recording electrodes 1040 E, 1040F, 1040G and 1040H are also aligned with the hollow passages 1323, 1322, 1321 and 1320, respectively.

[0410] After implantation in the calvarial bone of the assembly including the ICI 1300 and the attached shim 1350, the hollow passages 1320, 1321, 1322 and 1323 may be filled with an electrically conducting liquid (such as, for example, CSF) that is in contact with the sensing / recording electrodes 1040H, 1040G, 1040F and 1040E, respectively, allowing the sensing / recording electrodes 1040H, 1040G, 1040F and 1040E to sense (and / or record) cortical electrical signals. The surfaces 1357B, 1346B, 1358B, 1345B, 1345C and 1346B that are electrically connected to the stimulating electrodes 1340A-1340D may be used to pass stimulating currents into the cortical regions underlying the shim 1350.

[0411] It is noted that the structure and composition of the components of spring-loaded mechanisms 1355, 1356, 1357 and 1358 are given by way of example only and are not obligatory. Other different types of spring-loaded contact mechanisms may be used in the shims of the present application.

[0412] Reference is now made to FIG. 46 which is an isometric view illustrating the spring 1355B of FIG. 44. The spring 1355B may be made from a strip of electrically conducting elastic material that has a zig-zag shape. The spring 1356B is similar to the spring 1355B. the materials from which the springs 1355B and 1356B may be made are described in detail hereinabove with respect to FIG. 44.

[0413] Reference is now made to FIGS. 47-49 which are schematic cross-sectional views illustrating three different types of spring-loaded electrical contact mechanisms usable in some embodiments of the shims of the present application.

[0414] Turning to FIG. 47, the spring-loaded contact mechanism 1380 includes a contact pin 1383, an externally male threaded housing 1381, a folded spring 1384 and an end-plug 1382. The housing 1381 has a male thread formed on its entire external surface 138 IB and a female thread 1381C formed along part of its internal surface 1381E. The housing 1381 has a circular hole 138 ID formed therein. The contact pin 1383 has a first cylindrical portion 1383A and a second cylindrical portion 1383B. The diameter D15 of the cylindrical portion 1383A of the contact pin

[0415] 1383 is equal to the diameter of the circular opening 138 ID and the contact pin 1383 can slide back and forth within the opening 138 ID. but cannot escape outside of the opening because it is connected to the end 1384A of the spring 1384 and because the diameter D16 of the cylindrical portion 1383B is larger than the diameter of the opening 138 ID.

[0416] The end-plug 1382 has a circular cross section and may have two cylindrically shaped recesses 1382B and 1382C formed therein at equal distances from the axis 1355 passing at the center of the end-plug.1382. The end plug 1382 has a male thread 1382A formed along its circumference. The spring 1384 may be similar in shape to the springs 1205B and 1206B of Fig. 40 and is made from an electrically conducting material as disclosed in detail for the springs 1205B and 1206B. A first end 1384 A of the spring 1384 is soldered (by hot or cold soldering) to the second cylindrical portion 1383B of the contact pin 1383 and a second end 1384B of the spring

[0417] 1384 is soldered (by hot or cold soldering) to the end-plug 1382. Such hot and cold soldering methods are described in detail hereinabove with respect to the springs 1205B and 1206B of FIG. 40.

[0418] The end-plug 1382 and the contact-pin 1383 may be made from an electrically conducting metal or metallic alloy or may be coated or plated or covered with an electrically conducting metal or metallic alloy as disclosed in detail hereinabove with respect to the end-plugs 1205D and 1206D and the contact pins 1205 and 1206 of FIG. 40. As the contact pin 1383, the spring 1384 and the end-plug 1382 all conduct electricity, and as they are electrically coupled or connected to each other, when an electrical current is made to flow through an electrode (not shown in FIG. 47) in electrical contact with the surface 1383C of the contact pin 1383, the current may flow through the spring 1384 and the end-plug 1382. It is noted that in some embodiments of the spring-loaded contact mechanism 1380 the housing 1381 may be made from an electrically conducting material (such as, for example, a metal or a metallic alloy), this is not obligatory and in some embodiments of the spring-loaded contact mechanism 1380 the housing 1381 may be made from an electrically isolating material, such as, for example, an electrically isolating ceramic material or an electrically isolating polymer based material (for example, PP, PEEK, or any other suitably strong biocompatible electrically isolating material).

[0419] It is noted that while the housings 10205C and 1206C of the spring-loaded contact mechanisms 1205 and 1206, respectively have a smooth external surfaces that may be attached within the passages 1202A and 1202B, respectively by using a suitable adhesive, this is not obligatory and the spring-loaded contact mechanism may be attached to within a shim ( not shown) by forming a hollow passage having a female threaded internal surface that matches the male threaded external surface 1381B of the spring-loaded contact mechanism 1380. The spring-loaded contact mechanism 1380 may be then screwed into such a female threaded hollow passage by using a tool (not shown) that has two cylindrically shaped prongs (not shown) that are made to fit within the two recesses 1382B and 1382C of the end-plug 1382. By inserting the tool’s prongs into the recesses 1382B and 1382C and rotating the tool around the axis 1355, the spring-loaded contact mechanism 1380 may be screwed into such a female threaded passage of a shim.

[0420] Turning to FIG. 48, the spring-loaded contact mechanism 1390, includes a contact pin 1393 similar to the contact pin 1983, an externally male threaded housing 1391, a folded spring 1394 and an annular member 1395. The housing 1381 has a male thread formed on its entire external surface 1391B and a female thread 1391E formed along part of its internal surface 138 IF. The annular member 1395 has a circular hole 1395B formed therein. The contact pin 1393 has a first cylindrical portion 1393 A and a second (wider) cylindrical portion 1393B. The diameter of the cylindrical portion 1393A of the contact pin 1393 is equal to the diameter of the circular opening 1395B, and the contact pin 1393 can slide back and forth within the opening 1395B. but cannot escape outside of the of the housing 1391 because it is soldered to the end 1394A of the spring 1394 and because the diameter of the cylindrical portion 1393B is larger than the diameter of the opening 1395B.

[0421] The bottom part 1391F of the cylindrical housing 1391 has a circular cross section and may have two cylindrically shaped recesses 1391D and 1391E formed therein at equal distances from the longitudinal axis 1399 passing at the center of the cylindrically shaped housing 1391. The spring 1394 may be similar in shape to the springs 1205B and 1206B of Fig. 40 and is made from an electrically conducting material as disclosed in detail for the springs 1205B and 1206B (of FIG. 40). A first end 1394A of the spring 1394 is soldered (by hot or cold soldering) and a second end 1394B of the spring 1384 is soldered (by hot or cold soldering) to the surface 1391G of the bottom part 1391F of the housing 1391. Such hot and cold soldering methods are described in detail hereinabove with respect to the springs 1205B and 1206B of FIG. 40.

[0422] The housing 1391 and the contact-pin 1383, the spring 1394 and the annular member 1395 may be made from an electrically conducting metal or metallic alloy or may be coated or plated or covered with an electrically conducting metal or metallic alloy as disclosed in detail hereinabove with respect to the end-plugs 1205D and 1206D and the contact pins 1205 and 1206 of FIG. 40. As the contact pin 1393, the spring 1394 and the housing 1391 all conduct electricity, and as they are electrically coupled or connected to each other, when an electrical current is made to flow through an electrode (not shown in FIG. 48) in electrical contact with the surface 1393C of the contact pin 1393, the current may flow through the spring 1394 and the bottom part 1391F of the housing 1391.

[0423] Similar to the externally threaded spring-loaded contact mechanism 1380, the spring- loaded contact mechanism 1390 may be then screwed into a female threaded hollow passage by using a tool (not shown) that has two cylindrically shaped prongs (not shown) that are made to fit within the two recesses 1391D and 1391E of the housing 1391. By inserting the tool’s prongs into the recesses 1391D and 1391ED and rotating the tool around the axis 1399, the spring-loaded contact mechanism 1390 may be screwed into such a threaded passage of a shim.

[0424] It is noted that it may be desirable to reduce any parasitic capacitance and inductance introduced by the spring-loaded contact mechanisms of the present application in order to reduce the effects of such parasitic capacitance and inductance on the rise-time of any square or rectangular current pulses that may be applied by the electronics module of an ICI to any stimulating electrodes of the ICI. Turning to FIG. 49, the spring-loaded contact mechanism 1400 includes a housing 1401, a contact pin 1406 a coil-like spring 1404, an end plug 1410, an annular threaded member 1415 and a flexible electrically conducting wire 1407. The contact pin 1406 includes an electrically isolating contact pin body 1405 and an electrically conducting first contact pad 1409 firmly attached to the contact pin body 1405 (for example, by a suitable adhesive). The end-plug 1410 includes an electrically isolating end-plug body 1402 and an electrically conducting pad 1403 attached to the end-plug body 1402. The end-plug 1402 has a male threaded side 1402A. The annular threaded member 1415 has a circular opening 1415A formed therein and is male threaded on the external surface 1415B thereof.

[0425] The housing 1401 has a first female threaded part 1401B into which the male threaded side 1402A of the end-plug 1402 may be screwed. The housing 1401 has a second female threaded part 1401A into which the male threaded side 1415A of the annular threaded member 1415 may be screwed.

[0426] The contact pin 1405 has a first cylindrical part 1405A and a second cylindrical part 1405B. The diameter D18 of the first cylindrical part 1405A of the contact pin body 1405 is equal to the diameter of the opening 1415A. The diameter D19 of the second cylindrical part 1504B is larger than the diameter of the first cylindrical part 1405A, and is equal to the internal diameter of the housing 1401.

[0427] The contact pin bodyl405 has a hollow passage 1405E passing therethrough and the endplug body 1402 has a hollow passage 1402B passing therethrough. The flexible electrically conducting wire 1407 is soldered to the electrically conducting pad 1403 and to the contact pad 1409 and passes through the hollow passages 1402B and 1405E.

[0428] The spring 1404 may be a coiled spring and is disposed between the second part 1405B of the contact pin body 1405 and the end plug body 1402. The spring 1404 is made from an elastic electrically isolating material, such as, for example, thermoplastic polyurethane (TPU), Thermoplastic polyester elastomers (TPE) or other strong, elastic, electrically isolating polymers.

[0429] The design of the spring-loaded contact mechanism 1400 in which all the components of the spring-loaded contact mechanism except the electrically conducting pad 1403, the contact pad 1409 and the wire 1407 are made from electrically isolating materials may advantageously reduce the parasitic capacitance and inductance of the spring-loaded contact mechanism 1400. This may be advantageous in shims that have a relatively high thickness, such as, for example, shims shaped like the shim 120 of FIG. 8 that may have spring-loaded contact mechanisms (such as, for example, the spring-loaded contact mechanism 1400) attached within the passages 122A and 122B. The electrically conducting pad 1403 and the contact pad 1409 may be made from an electrically conducting material, such as, for example, a metal or a metallic alloy (such as, for example, gold, platinum, iridium or alloys thereof), alternatively, the electrically conducting pad 1403 and the contact pad 1409 may be made from a less expensive metal (such as, for example, copper, silver, or stainless steel) that may be plated or coated or covered by a more biocompatible metal or alloy like gold, platinum, iridium and various alloys thereof. The wire 1407 may be any type of suitable flexible electrically conducting wire such as, for example, a copper or silver or gold wire. The wire 1407 may or may not be electrically insulated but if it is insulated, the insulating material may be any suitable electrically isolating material such as, for example, Teflon®, Nylon® or polypropylene.

[0430] In some embodiments of the shims, the electrical contact mechanisms (such as, for example, the electrical contact mechanisms 1205 and 1206 of FIG. 40) are attached within the passages of the shim body such that they do not protrude beyond the surface of the second shimside of the shim body (for example, the second side 1202C of the shim body 1202 of FIG. 40).

[0431] However, in some embodiments of the shims, the electrical contact mechanisms (such as, for example, the electrical contact mechanisms 1205 and 1206, 1380, 1390 and) are attached within the passages of the shim such that a portion of the electrical mechanism protrudes from the second shim-side (for example, the second surface 1202C of the second shim-side 1201B of the shim body 1202 of FIG. 40). In such shim embodiments the effective thickness H of such shims should include the thickness of any part of the electrical contact mechanisms that protrudes beyond the surface 1202C of the second shim- side 120 IB.

[0432] Similarly, while in shim 140 (of FIG. 8), the surfaces 145C and 146D of the solid members 145 and 146 are flush with the second surface 142E of the second shim-side 141B, this is not obligatory and in some shim embodiments the solid members 145 and 146 may protrude from the second surface 142E. In such shim embodiments the effective thickness H of such shims should include the thickness of any part of the solid members that protrudes beyond the second surface 142E of the second shim- side 14 IB.

[0433] Furthermore, while in the shim 1050 (of FIG. 39), the second circular surface 1145B of the cylindrically-shaped solid member 1145 and the second circular surface 1146B of the cylindrically-shaped member 1146 are flush with the second circular surface 1142F of the second shim-side 1141B, this is not obligatory and in some shim embodiments the second circular surface 1145B of the cylindrically-shaped solid member 1145 and the second circular surface 1146B of the cylindrically- shaped member 1146 may protrude from the second surface 1142F of the second shim-side 1141B. In such shim embodiments the effective thickness H of such shims should include the thickness of any part of the cylindrically-shaped members included in the shim body 1142 (such as, for example, the cylindrically- shaped members 1145 and 1146) that protrudes beyond the surface 1142F of the second shim-side 1141B.

[0434] Further yet, while in the shim 1350 (of FIG. 45), the surfaces 1345B and 1345C of the electrically conducting member 1345 and the surface 1346B of the electrically conducting member 1346 are all flush with the second surface 1352B of the second shim-side 135 IB, this is not obligatory and in some shim embodiments the surfaces 1345B and 1345C of the electrically conducting member 1345 and the surface 1346B of the electrically conducting member 1346 may protrude from the second surface 1152B of the second shim-side 1351B. In such shim embodiments the effective thickness H of such shims should include the thickness of any part of the electrically conducting members (such as, for example, the electrically conducting members 1345 and 1346) that protrudes beyond the second surface 1152B of the second shim-side 1351B.

[0435] It is noted that for all shims that have a flat first side, the thickness of the shim is equal to the effective thickness of the shim. Such shims may include, for example, the shims 20, 100, 120, 140, 150, 200, 230, 240, 250, 260, 270, 280, 650 and 1100.

[0436] It is also noted that for all the shims that have a recess on their first side, the thickness of the shim is equal to the effective thickness of the shim. Such shims may include, for example, the shims 300, 1140 and 1350.

[0437] It is further noted that for all shims that have a first cylindrically shaped portion or part and a second cylindrical portion or part having a diameter larger than the diameter of the first cylindrically shaped portion or part, the effective thickness of the shim does not include the thickness of the first cylindrically shaped portion or part because the thickness of the first cylindrically shaped portion or part does not contribute to the total thickness of an assembly including the shim and a compatible ICI having a recess therein for accepting the first cylindrically shaped portion therewithin. Such shims may include, for example, the shims 340, 430, 530, 630 and 1200.

[0438] It is noted that for all ICIs that have a flat first side of the ICI (the side of the ICI that includes the stimulating and / or sensing electrodes), the effective (standard) thickness of the ICI is the distance between the surface 2A of the calvarial bone 2 and the first side of the ICI after implantation of the assembly including the ICI and the shim in the skull. This effective thickness of the ICI does not include the thickness of the side-tabs used to attach the ICI to the calvarial bone 2 (irrespective, of whether the side-tabs are formed as part of the housing of the ICI or are formed as part of the lid of the ICI). Such ICIs may include, for example, the ICIs 10, 60, 80 and 1000. It is noted that for all the two-part ICIs disclosed in the application (such as, for example, the two-part ICI 900 illustrated in FIGS. 36 and 37), the effective thickness T of the two-part ICI 900 is the distance between the surface 2 A of the calvarial bone 2 and the first side 704 A of the housing 704 after implantation. The effective thickness T does not include the thickness of the side-tabs 812A and 812B of the second ICI-part 800.

[0439] It is noted that for all ICIs that have a first cylindrically shaped portion (or part) and a second cylindrically shaped portion (or part) having a diameter larger than the diameter of the first cylindrically shaped portion or part, the effective (standardized) thickness of the ICI does not include the thickness of the first cylindrically shaped portion (or part) because the thickness of the first cylindrically shaped portion (or part) does not contribute to the total thickness of an assembly including the ICI and a compatible shim having a recess therein for accepting the first cylindrically shaped portion (or part) of the ICI therewithin. Such ICIs may include, for example, the ICIs 180 and 1300.

[0440] It is further noted that for all ICIs having a recess on their first ICI-side (the side of the ICI that includes the stimulating electrodes and / or the sensing / recording electrodes), such as, for example, the ICIs 310, 400, 500 and 600, the effective (standardized) thickness B of the ICI does not include the thickness ST of any part of the ICI that protrudes above the surface 2A of the calvarial bone 2 after implantation, as may be seen in FIGS. 22, 25, 29 and 32, respectively.

[0441] Reference is now made to FIG. 50 which is a schematic block diagram illustrating the steps of a method for determining in a specific patient the effective thickness of a shim of the present application, in accordance with an embodiment of the methods of the present application.

[0442] The method of FIG. 50 includes obtaining anatomical and / or functional data by using on the specific patient one or more tomographic anatomical and / or functional imaging methods (step 1502). The imaging methods may include CT, fMRI, MRI, of any other suitable tomographic imaging method. The method also includes using the anatomical and / or functional data to determine the distance D between the outer surface 2A of the calvarial bone 2 of the specific patient and a desired position of the second shim-side after implantation (step 1504).

[0443] The method also includes calculating H from D and B using the equation H=D-B, wherein B is the standardized effective thickness of the ICI to which the shim is to be attached before implantation (step 1506). The method may also (optionally) include manufacturing a shim having an effective thickness H (step 1508).

[0444] In some embodiments of the method that involve forming a recess in the calvarial bone 2, the desired position of the second shim-side may be a position in contact with at least a portion of a bottom of the recess made in the calvarial bone of the specific patient or in close proximity of the bottom of the recess. The desired position may be determined, inter alia, by the thickness of the calvarial bone 2 at the site of implantation, and by the minimal thickness of bone remaining below the bottom of the recess that is required in order to avoid breaching the calvarial bone during the forming of the recess.

[0445] In other embodiments of the method of FIG. 50 that involve forming a through-hole in the calvarial bone 2, (such as, for example, the through-hole 2F of FIG. 37), The desired position of the second shim-side may be a position in contact with at least a portion of an outer surface of the dura matter or in close proximity to the outer surface of the dura matter, or a position in contact with at least a portion of an arachnoid matter or in close proximity to the arachnoid matter, or a position in contact with at least a portion of the surface of a portion of pia matter or in close proximity thereto, or a position in contact with at least a portion of a surface of a cortex or in close proximity to the surface of the cortex.

[0446] Reference is now made to FIG. 51 which is a schematic block diagram illustrating a method for implanting in a patient an assembly including an ICI and a shim, in accordance with an embodiment of the methods of the present application.

[0447] The method of FIG. 51 includes providing a shim specifically manufactured for the patient and an ICI, the ICI includes one or more stimulating electrodes, one or more current return electrodes, and an electronics module suitably electrically coupled to the one or more stimulating electrodes and to the one or more current return electrodes, the ICI has a first side attachable to a first shim-side and a second side attachable to an outer surface of a calvarial bone of the patient, the ICI has a standardized effective thickness B and the shim has an effective thickness H, the shim has a first shim-side attachable to the first side of the ICI and a second shim-side, the shim includes one or more passages extending from the first shim-side to the second shim-side (step 1510). The method also includes surgically exposing the outer surface of the calvarial bone by making an incision in the scalp of the patient (stepl512). The method also includes surgically forming in the calvarial bone a recess having a depth (B+H) and a recess-bottom (stepl514). The method also includes inserting the assembly (including the ICI and the shim attached thereto) into the recess (step 1516). After the insertion of the assembly, the surgeon attaches the second side of the ICI to the outer surface 2A of the calvarial bone 2, wherein after the attaching of the second side of the ICI to the surface 2A of the calvarial bone 2, the second side of the shim is in contact with at least part of the bottom of the recess or is in close proximity to the bottom of the recess (step 1518). The method may also (optionally) include closing of the incision made in the scalp (step 1519). It is noted that the ICI of step 1510 may also include one or more sensing / recording electrodes. Reference is now made to FIG. 52 which is a schematic block diagram illustrating a method for implanting in a patient an assembly including an ICI and a shim, in accordance with an embodiment of the methods of the present application.

[0448] The method of FIG. 52 includes providing a shim specifically manufactured for the specific patient, the shim has a thickness H determined by using one or more anatomical and / or functional imaging methods performed on the specific patient, the ICI includes one or more stimulating electrodes, one or more current return electrodes, and an electronics module suitably electrically coupled to the one or more stimulating electrodes and to the one or more current return electrodes, the ICI has a first side attachable to a first shim-side and a second side attachable to an outer surface of a calvarial bone of the patient, the ICI has a known standardized effective thickness B, the shim has a first shim-side attachable to the first side of the ICI and a second shimside, the shim includes one or more passages extending from the first shim-side to the second shim-side (step 1520).

[0449] The method also includes surgically exposing the outer surface of the calvarial bone of the patient by making an incision in the scalp of the patient (step 1521). After making the incision, the surgeon surgically forms in the calvarial bone a through-hole spanning the entire thickness of the calvarial bone (step 1522). The surgeon then inserts the assembly into the through-hole (step 1524). After the insertion of the assembly, the surgeon attaches the second side of the ICI to the outer surface of the calvarial bone of the patient (step 1526). After the step of attaching, the second side of the shim is in contact with at least a portion of a target tissue underlying the through-hole or is in close proximity to the target tissue. The surgeon may also (optionally) close the incision in the scalp (step 1528).

[0450] Depending on the embodiment of the method, the target tissue of step 1524 may be an outer surface of the dura matter of the patient, or an arachnoid matter of the patient, or an outer surface of the pia matter of the patient, or the surface of a cortex of the patient. It is noted that the ICI of step 1520 may also include one or more sensing / recording electrodes.

[0451] Reference is now made to FIG. 53 which is a schematic block diagram illustrating the steps of a method for producing a shim in accordance with an embodiment of the methods of the present application.

[0452] The method of FIG. 53 includes providing an ICI having a standardized stimulating electrode configuration for delivering electrical stimuli to the brain of a specific patient (step 1530). The method also includes obtaining magnetic resonance imaging based tomographic data representative of areas in the cortex of the patient that exhibit increase in neuronal activity when the specific patient is presented with a task requiring attention (step 1532). It is noted that the dorsal attention network (DAN) is typically involved in tasks requiring top-down attention and goal-directed processing. Examples of suitable cognitive task types or categories that are known to activate the DAN when studied with task-based fMRI (or any other magnetic resonance imaging based tomographic method that is capable of detecting and tomographically mapping functional activation of brain region in response to a stimulus or a task presented to a patient) and that may be used as the task requiring attention of step 1532 are:

[0453] 1. “Visual Search Tasks”: Participants are asked to find a specific target among distractors, requiring focused attention and visual scanning.

[0454] 2. “Cueing Paradigms”: Tasks that involve spatial or temporal cues directing attention to specific locations or times.

[0455] 3. “Sustained Attention Tasks”: Tasks where participants need to maintain attention over prolonged periods, such as, for example, the continuous performance task (CPT).

[0456] 4. “Working Memory Tasks”: Tasks that require maintaining and manipulating information over short periods, such as, for example, the n-back task.

[0457] 5. “Task-Switching Paradigms”: Tasks that require switching attention between different tasks or rules, assessing cognitive flexibility.

[0458] 6. “Covert Attention Shifts”: Tasks where participants are asked to shift their attention without moving their eyes (covertly) to different spatial locations.

[0459] 7. “Posner Spatial Cueing Task”: A specific cueing task where participants respond to targets appearing at cued (valid) or un-cued (invalid) locations, assessing attentional shifts.

[0460] 8. “Mental Rotation Tasks”: Tasks that involve mentally rotating objects, requiring spatial attention and visualization.

[0461] 9. “Attention to Motion”: Tasks where participants must focus on moving objects or detect motion in a visual field.

[0462] 10. “Selective Attention Tasks”: Tasks where participants must focus on specific stimuli while ignoring others, such as, for example, dichotic listening tasks or Stroop tasks.

[0463] These tasks are designed to engage various aspects of attention and working memory, thereby activating the dorsal attention network as seen in task-based fMRI studies.

[0464] The method also includes determining from the magnetic resonance imaging based tomographic data the location in the brain of one or more target brain regions requiring electrical stimulation (step 1534).

[0465] The method also includes producing the shim by configuring the one or more passages of the shim for selectively directing the electrical stimuli to the one or more target brain regions requiring electrical stimulation (step 1536). In some embodiments of the method the step of producing also includes the step of filling the one or more passages with an electrically conducting material, or attaching within one or more of the passages an electrical contact mechanism (step 1358).

[0466] The electrically conducting material used in step 1358 may be, for example, an electrically conducting gel or an electrically conducting polymer. For example, in some embodiments, the step of filling may include filling one or more of the passages with a liquid including precursors for forming an electrically conducting polymer and polymerizing the precursors to form a solid electrically conducting polymer within the one or more passages.

[0467] In some embodiments of the method, the electrical contact mechanism attached within the one or more passages may be any one of the electrical contact mechanisms 1205, 1206, 1380, 1390 and 1400 disclosed hereinabove.

[0468] In some embodiments of the method, the step of producing (step 1356) may include the steps of arranging within a mold one or more electrically conducting members having a desired shape, filling the mold with a liquid comprising at least one monomer and polymerizing the at least one monomer to form a shim body including the one or more electrically conducting members passing therethrough.

[0469] In some embodiments of the method, the step of producing (step 1536) may be selected from the following steps:

[0470] 1. Producing the personally adapted shim by using an additive manufacturing process.

[0471] 2. Producing the personally adapted shim by using a subtractive manufacturing process, and

[0472] 3. Producing the personally adapted shim by using a hybrid manufacturing process combining one or more additive manufacturing steps and one or more subtractive manufacturing steps.

[0473] In some embodiments of the method the step of producing may include the steps of, arranging within a mold one or more electrically conducting members having a desired shape, filling the mold with a liquid comprising at least one monomer and polymerizing the at least one monomer to form a shim body including the one or more electrically conducting member passing therethrough.

[0474] In some embodiments of the method the step of producing includes the steps of, providing a shim body having the desired dimensions of the shim, machining the shim body to form one or more hollow passages passing therethrough, and sealingly attaching within the one or more hollow passages one or more electrically conducting members formed to match the shape of the one or more hollow passages. The one or more electrically conducting members may be metallic members (made from a metal, or a metallic alloy, or members coated with a metal or a metallic alloy. In some embodiments the electrically conducting members may be members made from or including an electrically conducting polymer.

[0475] In embodiments in which the ICI is a two-part ICI having a first ICI-part and a second ICI- part, (such as, for example, the two-part ICI 900 of FIGS. 36-37 that has a first ICI-part 700 and a second IVI part 800), it is possible to provide the surgeon with an individualized kit that includes two components attachable to the first ICI-part of an intracalvarial two-part (ICI) implantable in a calvarial bone of the skull of a patient. The first ICI-part of the two-part ICI includes an electronics module, one or more stimulating electrodes electrically coupled to the electronics module and one or more current-return electrodes electrically coupled to the electronics module. The first ICI-part has a first side including the one or more stimulating electrodes and a second side opposite the first side. The second ICI-part is attachable to the first ICI-part. The two-part ICI has a standard thickness K.

[0476] The individualized kit may include a shim having an electrically insulating shim body, the shim body has a first shim-side attachable to the first side of the first ICI-part and a second shimside opposite the first shim-side, the shim body has an effective thickness H. The shim body has one or more passages extending from the first shim-side to the second shim-side. The individualized kit may also include a second ICI-part that has a first side attachable to the second side of the first ICI-part. The second ICI-part has a second side attachable to an outer surface of the calvarial bone. The second ICI-part has an effective thickness S.

[0477] The effective thicknesses H and S are specifically adapted for an individual patient such that the sum K+H+S is such that when an assembly including the first ICI-part, the second ICI-part and the shim is inserted into a recess formed in the calvarial bone that has a recess depth equal to the sum B+H+S and has a recess-bottom, and the second side of the second ICI-part is attached to an outer surface of the calvarial bone, the second shim-side is in contact with at least part of the recess-bottom or in close proximity to the recess-bottom.

[0478] In some embodiments of the kit where the assembly is intended to be implanted in a through- hole made in the calvarial bone 2, after the shim and the second ICI-part are attached to the first ICI-part and the assembly including the shim, the first ICI-part and the second ICI-part is implanted in the through-hole (as illustrated in the example of FIG. 37), the effective thicknesses H and S are specifically adapted for the individual patient such that the sum B+H+S is such that when the assembly including the first ICI-part, the second ICI-part and the shim is inserted into the through-hole, and the second side of the second ICI-part is attached to the outer surface 2A of the calvarial bone 2, the second shim-side is in contact with at least part of or in close proximity to a stimulation target. The stimulation target may be an outer surface of the dura matter of the patient, or an arachnoid matter of the patient, or an outer surface of a pia matter of the patient, or a surface of a cortex of the patient.

[0479] In some embodiments of the individualized kit, the second ICI-part includes a permanent magnet disposed therein.

[0480] In some embodiments of the individualized kit the second ICI-part may be: A second ICI part having a permanent magnet embedded therein, or a second ICI part having a hollow space formed therein for placing a permanent magnet therein and an openable and clo sable lid for closing the hollow space, or a second ICI-part including an induction coil disposed or embedded therein. The induction coil may include two electrical contacts terminating on the surface of the first side of the second ICI-part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part, or a second ICI-part including a permanent magnet and an induction coil. The induction coil may include two electrical contacts terminating on the surface of the first side of the second ICI-part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part.

[0481] In some embodiments of the kit, the one or more passages of the shim may be, one or more hollow passages for allowing electrical signals to pass through the one or more hollow passages, or one or more passages at least partially filled with an electrically conducting material, or one or more passages having an electrical contact mechanism attached therewithin, or one or more passages having a spring-loaded electrical contact mechanism attached therewithin, or one or more passages having a composite electrical contact mechanism attached therewithin the composite electrical contact mechanism includes an electrical contact mechanism and an electrically conducting material electrically connected to the electrical contact mechanism, or any non- mutually exclusive combinations thereof.

[0482] In some embodiments of the kit, the electrically conducting material is selected from, an electrically conductive metal, an electrically conductive metallic alloy, an electrically conductive polymer and an electrically conductive gel.

[0483] It is noted that while most of the ICIs (including the two-part ICI illustrated in FIG. 36-37) disclosed hereinabove included two side-tabs for attaching the ICI to the outer surface 2A of the calvarial bone 2, this is not obligatory and some embodiments of the ICIs may include more than two side-tabs. Furthermore, some embodiments of the ICI may have no side-tabs at all. For example, in some embodiments, such ICIs without any side-tabs may be attached to the calvarial bone 2 by using a suitable biocompatible adhesive for attaching the housing of the ICI to the side of a recess or through-hole made in the calvarial bone 2. In some other embodiments, the ICI may have a suitable laterally-extending flange (not shown) formed on the lid of the ICI. Such a flange may have multiple holes formed therein for inserting bone screws therethrough to attach the flange to the surface 2A of the calvarial bone 2. Any other suitable method for attaching the ICI to the calvarial bone 2 may be used in the implantation of the ICI and shim assemblies of the present application.

[0484] Furthermore, while all the ICIs disclosed herein are illustrated as having a single annular current return electrodes (such as, for example, the current return electrodes 30F, 64F 80F. 180F. 310F, 408F, 508F, 608F 700F and 13O8F), this is not obligatory and some ICI embodiments may have one or multiple current return electrodes that may be placed anywhere on the surface of the ICI housing or even on the lid of the ICI. Such current return electrodes need not be annular and may have various different shapes and sizes. The shims disclosed in the present application may be successfully used with such ICIs that have other types and configurations of current return electrode(s).

[0485] It is noted that while the stimulating electrodes of the ICIs disclosed in the present application may, in some embodiments, be used for stimulating various different cortical regions of the patient’s brain, the use of such stimulating electrodes is not limited to stimulating only cortical regions. The stimulating electrodes may be used to stimulate other regions of the brain such as, for example sub-cortical brain regions underlying the cortex. Such stimulation may be performed by increasing the currents delivered to the brain such that other brain regions are also stimulated. Application of such currents may result in excitation (or depression, depending on the polarity and / or shape and / or amplitude of the electrical currents flowing through the electrodes) of cortical regions but may also result in excitation (or depression) of other brain regions underlying the cortex.

[0486] It is further noted that the methods disclosed hereinabove for locating brain regions activated when the patient is presented with a task requiring attention are not limited to functional magnetic resonance imaging (fMRI) using blood oxygen level detection (BOLD) methods. Some other magnetic resonance imaging-based methods may be used including diffusion magnetic resonance imaging (dMRI) methods and resting state functional magnetic resonance imaging (rsfMRI). Similarly, structural MRI may be used (possibly together with CT) for determining the thickness of the calvarial bone at the desired implantation site. However, it will be appreciated that any other known tomography imaging method that is based on magnetic resonance imaging tomography techniques or CT or any other computed tomography imaging method that have a sufficient resolution may be used in the methods of the present application.

[0487] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A shim, attachable to an intracalvarial implant (ICI), the ICI is implantable in a calvarial bone of a patient, the ICI comprises a first ICI- side including one or more stimulating electrodes for electrically stimulating one or more brain regions of the patient, a second ICI side opposing the first-ICI side, at least one current-return electrode and an electronics module electrically coupled to the one or more stimulating electrodes and to at least one current-return electrode, the shim comprising: an electrically insulating shim body having a first shim-side attachable to the first ICI- side, and a second shim-side, the shim includes one or more passages extending from the first shim-side to the second shim-side, the one or more passages are configured to allow electrical currents to flow from at least some of the one or more stimulating electrodes and to exit from the second shimside and stimulate one or more stimulation targets of the one or more brain regions of the patient after the ICI and the shim attached thereto are implanted in the calvarial bone.

2. The shim according to claim 1, wherein the ICI also includes one or more sensing / recording electrodes electrically coupled to the electronics module, and wherein some passages of the one or more passages of the shim allow the one or more sensing / recording electrodes to sense / record electrical signals from the patient’ s brain.

3. The shim according to any one of the preceding claims, wherein the shim is detachably attachable to the ICI.

4. The shim according to any one of claims 1-3, wherein one or more shim parameters selected from, the number of the one or more passages, the shape of the one or more passages, the configuration of the one or more passages within the shim body, the arrangement of the one or more passages on the first shim-side and the arrangement of the one or more passages on the second shim-side are determined for a specific patient based on magnetic resonance imaging tomographic data acquired from the specific patient prior to implantation of the ICI.

5. The shim according to claim 4, wherein the magnetic resonance imaging tomographic data comprises data representative of regions in the brain of the specific patient that exhibit increase in neuronal activity when the specific patient is presented with a task requiring attention.

6. The shim according to any one of claims 1-5, wherein the ICI has a standard effective thickness B and wherein the effective thickness H of the shim is specifically determined for a specific patient such that the value of B+H is equal to a depth Z of an implantation recess made in a selected region of the calvarial bone of the specific patient.

7. The shim according to any one of claims 1-5, wherein the ICI has a standard thickness B and wherein the effective thickness H of the shim is determined for a specific patient such that when an assembly including the ICI and the shim attached thereto is implanted in a through-hole penetrating the entire thickness of the calvarial bone, the value of B+H is equal to the distance between an outer surface of the calvarial bone and a desired position of the second shim-side.

8. The shim according to claim 7, wherein the desired position of the second shim-side is selected from, an outer surface of a dura matter or in close proximity thereto, a portion of an arachnoid matter, a surface of a pia matter or in close proximity thereto and a surface of the patient’s brain or in close proximity thereto.

9. The shim according to any one of claims 1-8, wherein the shim body includes an attachment mechanism for attaching the shim to the ICI.

10. The shim according to claim 9, wherein the attachment mechanism is selected from, an adhesive for sealingly attaching the first side of the ICI to the first shim- side without covering the surface of any of the electrodes included in the first ICI-side, a bayonet attachment mechanism, a keyed bayonet attachment mechanism, a female thread formed in a recess on the first shim-side of the shim body for receiving a compatible male thread formed on the first ICI-side, and a male thread formed on the first shim- side of the shim body for being screwed into a compatible female thread formed in the first ICI-side.

11. The shim according to claim 10, wherein the attachment mechanism is a bayonet attachment mechanism selected from, two or more pins formed on the first shim-side of the shim-body, the pins are configured to be inserted into two or more matching receiving slots formed in the first ICI-side, two or more receiving slots formed in the shim body, the two or more receiving slots are configured to receive two or more pins protruding from the first ICI-side, two or more pins formed on the first shim-side of the shim body, the two or more pins have sizes and / or shapes different from each other, the two or more pins are adapted to be inserted into two or more compatible keyed receiving slots formed in the first ICI-side, for ensuring proper alignment of the shim with the ICI, two or more pins formed on the first ICI-side, the two or more pins have sizes and / or shapes different from each other, the two or more pins are adapted to be inserted into two or more compatible keyed receiving slots formed in the first shim- side for ensuring proper alignment of the shim with the ICI,two or more pins formed on the circumference of the shim body and configured to be inserted into two or more matching receiving slots formed in the inner surface of a recess formed in the first ICI-side, two or more pins formed on the inner surface of a recess formed within the first ICI-side, the two or more pins are configured to be inserted into two or more matching receiving slots formed in the circumference of a recess formed in the first shim-side, two or more differently sized and / or differently shaped pins formed on the circumference of the shim body and adapted to be inserted into two or more matching differently sized and / or differently shaped keyed receiving slots formed in an inner surface of a recess formed in the first ICI-side, for ensuring proper alignment of the shim with the ICI, and two or more differently sized and / or differently shaped pins formed on the circumference of the shim and adapted to be inserted into two or more matching differently sized and / or differently shaped keyed receiving slots formed in an inner surface of a recess formed in the first ICI-side, for ensuring proper alignment of the shim with the ICI.

12. The shim according to any one of claims 9-11, wherein the shim also includes a perforated sealing gasket attached thereto, the perforated gasket has one or more perforations, and wherein at least one perforation of the one or more perforations is configured for circumscribing the circumference of at least one of the one or more stimulating electrodes of the ICI.

13. The shim according to any one of claims 9-11, wherein the ICI includes multiple stimulating electrodes and wherein the shim also includes a perforated sealing gasket attached thereto, the perforated gasket has one or more perforations, wherein at least one perforation of the one or more perforations is configured for circumscribing two or more electrodes of the multiple stimulating electrodes of the ICI.

14. The shim according to any one of claims 9-11, wherein the ICI also includes one or more sensing / recording electrodes, wherein some of the one or more passages allow the one or more sensing / recording electrodes to sense / record electrical signals from the patient’ s brain, and wherein the shim also includes a perforated sealing gasket attached thereto, the perforated gasket has one or more perforations, wherein each sensing / recording electrode of the sensing / recording electrodes of the ICI is circumscribed by a perforation of the one or more perforations of the perforated gasket.

15. The shim according to any one of claims 1-14, wherein the one or more passages are selected from, one or more hollow passages, one or more passages at least partially filled with an electrically conducting material,one or more passages with an electrical contact mechanism attached there within, one or more passages having a composite electrical contact mechanism attached therewithin the composite electrical contact mechanism includes an electrical contact mechanism and an electrically conducting material electrically connected to the electrical contact mechanism, and any non-mutually exclusive combinations thereof.

16. The shim according to claim 15, wherein the electrically conducting material is selected from an electrically conductive metal, an electrically conductive metallic alloy, an electrically conductive polymer, an electrically conducting hydrogel, and an electrically conductive gel.

17. The shim according to any one of claims 1-16, wherein at least some passages of the one or more passages are hollow passages, each hollow passage has at least one opening that opens at the first shim-side and at least one opening that opens at the second shim-side.

18. The shim according to claim 17 wherein each opening of the at least one opening on the first shim-side circumscribes one or more electrodes when the first shim-side is attached to the first ICI-side.

19. The shim according to claim 17, wherein the shim also includes a perforated sealing gasket having one or more perforations formed therein, wherein at least some of the one or more passages are hollow passages, and wherein the contour of each of the perforations circumscribes the at least one opening of the at least some hollow passages that are located on the first shim-side.

20. The shim according to claim 1, wherein the one or more passages are hollow passages and wherein the one or more hollow passages are selected from, hollow passages having a single opening on the first shim-side and a single opening on the second shim-side, hollow passages having a single opening on the first shim-side and two or more openings on the second shim-side, hollow passages having two or more openings on the first shim-side and one opening on the second shim-side, and any non-mutually exclusive combinations thereof.

21. The shim according to any one of claims 1-16, wherein the one or more passages are selected from, cylindrical passages, frustoconical passages, part frustoconical part cylindrical passages, tapering passages, irregularly shaped passages,bifurcating passages, branching passages, branching passages having one or more branches terminating at the first shim-side and one or more branches terminating at second shim-side, and any non-mutually exclusive combinations thereof.

22. The shim according to any one of claims 1-7, wherein the one or more passages are selected from, branching hollow passages having a single opening on the first shim-side and a plurality of openings on the second shim-side, branching hollow passages having a plurality of openings on the first shim-side and a single opening on the second shim-side, and branching hollow passages having a plurality of openings on the first shim-side and a plurality of openings on the second shim-side.

23. The shim according to claim 20, wherein the one or more passages are selected from, hollow passages having a single opening having a first cross-sectional area on the first shimside and a single opening having a second cross-sectional area on the second shim-side, wherein the first cross-sectional area is equal to the second cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a single opening having a second cross-sectional area on the second shim-side, wherein the first cross-sectional area is larger than the second cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a single opening having a second cross-sectional area on the second shim-side, wherein the first cross-sectional area is smaller than the second cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a plurality of openings having a total combined cross-sectional area on the second shimside, wherein the first cross-sectional area is equal to the total combined cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a plurality of openings having a total combined cross-sectional area on the second shimside, wherein the first cross-sectional area is larger than the total combined cross-sectional area, hollow passages having a single opening having a first cross-sectional area on the first shimside and a plurality of openings having a total combined cross-sectional area on the second shimside, wherein the first cross-sectional area is smaller than the total combined cross-sectional area, hollow passages having a plurality of openings having a total combined cross-sectional area on the first shim-side and a single opening having a second cross-sectional area on the secondshim-side, wherein the total combined cross-sectional area is equal to the second cross-sectional area, hollow passages having a plurality of openings having a total combined cross-sectional area on the first shim-side and a single opening having a second cross-sectional area on the second shim-side, wherein the total combined cross-sectional area is smaller than the second cross- sectional area, hollow passages having a plurality of openings having a total combined cross-sectional area on the first shim-side and a single opening having a second cross-sectional area on the second shim-side, wherein the total combined cross-sectional area is larger than the second cross-sectional area, hollow passages having a first plurality of openings having a first total combined cross- sectional area on the first shim-side and a second plurality of openings having a second total combined cross-sectional area on the second shim-side, wherein the first total combined cross- sectional area is equal to the second total combined cross-sectional area, hollow passages having a first plurality of openings having a first total combined cross- sectional area on the first shim-side and a second plurality of openings having a second total combined cross-sectional area on the second shim-side, wherein the first total combined cross- sectional area is larger than the second total combined cross-sectional area, hollow passages having a first plurality of openings having a first total combined cross- sectional area on the first shim-side and a second plurality of openings having a second total combined cross-sectional area on the second shim-side, wherein the first total combined cross- sectional area is smaller than the second total combined cross-sectional area, passages having an electrical contact mechanism attached therein, passages having a composite electrical contact mechanism attached therein, passages partially filled or entirely filled with an electrically conducting material, passages including therein an electrical contact mechanism electrically coupled to a body comprising an electrically conducting material, and any non-mutually exclusive combinations thereof.

24. The shim according to claim 1, wherein the one or more stimulating electrodes of the first ICI-side comprise a plurality of stimulating electrodes and wherein at least one passage of the one or more passages is selected from, a hollow passage having a single opening having a cross-sectional area on the first shimside, wherein when the shim is attached to the first ICI-side, the single opening circumscribes a single electrode or a portion of a single electrode within the cross-sectional area thereof, anda hollow passage having a single opening on the first shim-side, wherein when the shim is attached to the first ICI-side, the single opening circumscribes two or more electrodes within the cross-sectional area thereof.

25. The shim according to claim 1, wherein the one or more electrodes of the first ICI-side comprise a single electrode having an electrode surface area and wherein at least one passage of the one or more passages is a hollow passage having a single opening with a first cross-sectional area on the first shim-side, wherein when the shim is attached to the first ICI-side, the single opening circumscribes only a portion of the surface area of the single electrode within the first cross-sectional area thereof.

26. The shim according any one of claims 1-25, wherein the shim body is selected from, a shim body made of or including a biocompatible ceramic material, a shim body made of or including biocompatible polymer-based material, a shim body covered with or coated with a biocompatible material, and a shim body covered with or coated with a biocompatible polymer-based material.

27. The shim according to any one of claims 1-26, wherein the shim includes an alignment mechanism to ensure proper alignment of the shim with respect to the ICI after the shim is attached to the ICI.

28. The shim according to claim 27, wherein the alignment mechanism is selected from, two or more keyed notches formed in the shim and two or more corresponding protrusions formed on the ICI, two or more keyed notches formed in the ICI and two or more corresponding protrusions formed on the shim body, and a first alignment marker on the shim and a second alignment marker on the ICI.

29. The shim according to claim 1, wherein the effective thickness H of the shim is the thickness contributed by the shim to the total thickness of an assembly including the ICI and the shim attached thereto.

30. The shim according to claim 29, wherein the total thickness of the assembly excludes the thickness ST of any portion of the ICI that protrudes from the external surface of the calvarial bone after implantation.

31. The shim according to any one of claims 1, 29 and 30, wherein the effective thickness H of the shim includes the thickness of a contact pad protruding from the second shim-side.

32. The shim according to claim 1, wherein the shim is sealingly attachable to the first ICI- side, to reduce current leakage through the attachment region between the first shim- side and the first ICI-side.

33. The shim according to claim 1, wherein the shim is manufactured using a method selected from, an additive manufacturing method, a subtractive manufacturing method, and a manufacturing process combining an additive manufacturing method and a subtractive manufacturing method.

34. The shim according to claim 1, wherein the ICI is a two-part ICI including a first ICI- part and a second ICI-part attached to the first ICI-part.

35. The shim according to claim 34, wherein the first ICI-part includes the electronics module, the one or more stimulating electrodes, and at least one current-return electrode, the first ICI-part has a known standard effective thickness K, the second ICI-part comprises a second part housing, a magnet disposed within the second part housing and an induction coil disposed within the second part housing and electrically couplable to the electronics module of the first ICI-part using two contact pads included in the second ICI-part and wherein the second ICI-part has an effective thickness S.

36. The shim according to claim 35, wherein the effective thickness S of the second ICI- part is an effective thickness determined for each specific patient based on data obtained from using anatomical and functional tomographic imaging methods on the specific patient.

37. The shim according to claim 35, wherein the effective thickness S is a known standard effective thickness and wherein one or more shim parameters selected from, the effective thickness of the shim, the number of the one or more passages, the shape of the one or more passages, the configuration of the one or more passages within the shim body, the arrangement of the one or more passages on the first shim-side and the arrangement of the one or more passages on the second shim-side are determined for a specific patient based on magnetic resonance imaging tomographic data and / or anatomical tomographic data acquired from the specific patient prior to implantation of the ICI.

38. The shim according to claim 35, wherein the effective thickness S of the second ICI- part is an effective thickness determined for each specific patient based on data obtained from using anatomical and / or functional tomographic imaging methods on the specific patient, and wherein one or more shim parameters selected from, the effective thickness of the shim, the number of the one or more passages, the shape of the one or more passages, the configuration of the one or more passages within the shim body, the arrangement of the one or more passages on the first shim-side and the arrangement of the one or more passages on the second shim-side aredetermined for the specific patient based on magnetic resonance imaging tomographic data and / or anatomical tomographic data acquired from the specific patient prior to implantation of the ICI.

39. An implantable assembly comprising the ICI and the shim according to any one of claims 1-5, attached together.

40. A method for producing the shim according to claim 1, the method comprising the steps of: providing an ICI having a standardized stimulating electrode configuration for delivering electrical stimuli to the brain of a specific patient; obtaining magnetic resonance imaging tomographic data representative of areas in the patient’ s brain that exhibit increase in neuronal activity when the specific patient is presented with a task requiring attention; determining from the magnetic resonance imaging tomographic data one or more brain target regions requiring electrical stimulation; and producing the shim by configuring the one or more passages of the shim for selectively directing the electrical stimuli to the one or more one or more brain regions of the patient requiring electrical stimulation.

41. The method according to claim 40, wherein the step of producing is selected from the steps of, producing a personally adapted shim by using an additive manufacturing process, producing a personally adapted shim by using a subtractive manufacturing process, and producing a personally adapted shim by using a hybrid manufacturing process combining one or more additive manufacturing steps and one or more subtractive manufacturing steps.

42. The method according to claim 40, wherein the step of producing also includes the step of filling the one or more passages with an electrically conducting material.

43. The method according to claim 42, wherein the step of filling comprises filling the one or more passages with a material selected from an electrically conducting gel and an electrically conducting polymer.

44. The method according to claim 42, wherein the step of filling comprises filling the one or more passages with a liquid comprising precursors for forming an electrically conducting polymer and polymerizing the precursors to form a solid electrically conducting polymer within the one or more passages.

45. The method according to claim 40, wherein the step of producing comprises the steps of, arranging within a mold one or more electrically conducting members having a desired shape, filling the mold with a liquid comprising at least one monomer, and polymerizing the at least onemonomer to form a shim body including the one or more electrically conducting members passing therethrough.

46. The method according to claim 40, wherein the step of producing comprises the steps of, providing a shim body having the desired dimensions of the shim, machining the shim body to form one or more hollow passages passing therethrough, and sealingly attaching within the one or more hollow passages one or more electrically conducting members formed to match the shape of the one or more hollow passages.

47. The method according to any one of claims 45-46, wherein the one or more electrically conducting members are selected from, metallic members, metal coated members and members comprising an electrically conducting polymer.

48. A method for determining the effective thickness H of the shim according to claim 1 for a specific patient, the shim has a first shim- side attachable to an ICI implantable in a calvarial bone of a specific patient and a second shim-side adapted for facing a brain stimulation target, the ICI has a known effective thickness B, the method comprising the steps of: obtaining anatomical and / or functional tomographic imaging data by using on the specific patient one or more tomographic anatomical and / or functional imaging methods to image a head of the specific patient; using the anatomical and / or functional tomographic imaging data to determine a distance D between an outer surface of a calvarial bone of the patient and a desired position of the second shim-side after implantation; and calculating H from D and B, such that H = D-B.

49. The method of claim 48, wherein the method also includes the step of manufacturing the shim having an effective thickness H.

50. The method according to any one of claims 48-49, wherein the desired position of the second shim-side is selected from, a position in contact with at least a portion of a bottom of a recess made in the calvarial bone of the specific patient or in close proximity to the bottom of the recess, a position in contact with at least a portion of an outer surface of a dura matter or in close proximity thereto, a position in contact with at least a portion of an arachnoid matter or in close proximity thereto, a position in contact with at least a portion of a surface of a pia matter or in close proximity thereto, andI l l a position in contact with at least a portion of a surface of the patient’s brain or in close proximity thereto.

51. A method for implanting in a patient an assembly including an ICI and a shim, the method comprising the steps of: providing a shim specifically manufactured for the patient and an ICI, the ICI includes one or more stimulating electrodes, one or more current return electrodes, and an electronics module suitably electrically coupled to the one or more stimulating electrodes and to the one or more current return electrodes, the ICI has a first ICI-side attachable to a first shim-side and a second ICI-side opposing the first ICI-side and attachable to an outer surface of a calvarial bone of the patient, the ICI has a standardized effective thickness B and the shim has an effective thickness H, the shim has a first shim-side attachable to the first ICI-side and a second shim-side, the shim includes one or more passages extending from the first shim-side to the second shim-side; surgically exposing the outer surface of the calvarial bone of the patient by making an incision in a scalp of the patient; surgically forming in the calvarial bone a recess having a depth (B+H) and a recessbottom; inserting the assembly including the ICI and the shim attached thereto into the recess; and attaching the ICI or the assembly to the calvarial bone, wherein after the step of attaching, the second shim-side is in contact with at least part of the recess-bottom or is in close proximity to the recess-bottom.

52. The method according to claim 51, wherein the method also includes the step of closing the incision made in the step of surgically exposing.

53. The method according to any one of claims 51 and 52, wherein the ICI also includes one or more sensing / recording electrodes disposed in the first ICI-side and operatively connected to the electronics module of the ICI, and wherein some passages of the shim are configured for allowing recording electrical signals from the patient’ s brain.

54. A method for implanting in a calvarial bone of a specific patient an assembly including an ICI and a shim, the method comprising the steps of: providing a shim specifically manufactured for the specific patient, the shim has a thickness H determined by using one or more anatomical and / or functional imaging methods performed on the specific patient, the ICI includes one or more stimulating electrodes, one or more current return electrodes, and an electronics module suitably electrically coupled to the one or more stimulating electrodes and to the one or more current return electrodes, the ICI has a first ICI-side attachable to the shim and a second ICI-side, the ICI is attachable to the calvarial bone, the ICI has a knownstandardized effective thickness B, the shim has a first shim-side attachable to the first ICI-side and a second shim-side, the shim includes one or more passages extending from the first shim-side to the second shim-side; surgically exposing the outer surface of the calvarial bone of the patient by making an incision in a scalp of the patient; surgically forming in the calvarial bone a through-hole spanning the entire thickness of the calvarial bone; inserting the assembly into the through-hole; and attaching the ICI or the assembly to the calvarial bone of the patient, wherein after the attaching, the second shim-side is in contact with at least a portion of a brain tissue underlying the through-hole or is in close proximity to the brain tissue.

55. The method according to claim 54, wherein the brain tissue is selected from, an outer surface of the dura matter of the patient, an arachnoid matter of the patient, an outer surface of a pia matter of the patient, and a surface of the patient’ s brain.

56. The method according to any one of claims 54-55, wherein the method also includes the step of closing the incision made in the step of surgically exposing.

57. The method according to any one of claims 54-56, wherein the ICI also includes one or more sensing / recording electrodes disposed in the first ICI-side and operatively connected to the electronics module of the ICI, and wherein some passages of the one or more passages of the shim are configured for allowing recording electrical cortical signals from the patient’ s brain.

58. An individualized kit attachable to a first ICI-part of an intracalvarial two-part ICI implantable in a implantation space within the calvarial bone of the skull of a patient, the two-part ICI has a first ICI-part including an electronics module, one or more stimulating electrodes electrically coupled to the electronics module and one or more current-return electrodes electrically coupled to the electronics module, the first ICI-part has a first side including the one or more stimulating electrodes and a second side opposing the first side of the first ICI-part, the two-part ICI has a second ICI-part attachable to the first ICI-part, the first ICI-part has a standard thickness K, the kit comprising: a shim having an electrically insulating shim body, the shim body has a first shim-side attachable to the first side of the first ICI-part and a second shim-side opposing the first shim-side, the shim body has an effective thickness H, the shim body has one or more passages extending from the first shim-side to the second shim-side; anda second ICI-part having a first side attachable to the second side of the first ICI-part and a second side attachable to the calvarial bone, the second ICI-part has an effective thickness S, wherein the effective thicknesses H and S are specifically adapted for an individual patient so that the sum K+H+S is such that when an assembly including the first ICI-part, the second ICI-part and the shim is inserted into a recess formed in the calvarial bone and having a depth equal to the sum K+H+S and a recess-bottom, and the second side of the second ICI-part is attached to the calvarial bone, the second shim-side is in contact with at least part of the recess-bottom or in close proximity to the recess-bottom.

59. The kit according to claim 58, wherein the second ICI-part includes a permanent magnet disposed therein.

60. The kit according to claim 59, wherein the second ICI-part is selected from, a second ICI-part having a permanent magnet embedded therein, a second ICI-part having a hollow space formed therein for placing a permanent magnet therein and an openable and closable lid for closing the hollow space, a second ICI-part comprising an induction coil disposed or embedded therein, the induction coil includes two electrical contacts terminating on the surface of the first side of the second ICI- part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part, and a second ICI-part including a permanent magnet and an induction coil, the induction coil includes two electrical contacts terminating on the surface of the first side of the second ICI-part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part.

61. The kit according to any one of claims 58-60, wherein the one or more passages are selected from, one or more hollow passages for allowing electrical signals to pass through the one or more hollow passages, one or more passages at least partially filled with an electrically conducting material, one or more passages having an electrical contact mechanism attached therewithin, one or more passages having a spring-loaded electrical contact mechanism attached therewithin, one or more passages having a composite electrical contact mechanism attached therewithin the composite electrical contact mechanism includes an electrical contact mechanism and an electrically conducting material electrically connected to the electrical contact mechanism, and any non-mutually exclusive combinations thereof.

62. The kit according to claim 61, wherein the electrically conducting material is selected from, an electrically conductive metal, an electrically conductive metallic alloy, an electrically conductive polymer and an electrically conductive gel.

63. An individualized kit attachable to a first ICI-part of an intracalvarial two-part ICI implantable within the calvarial bone of the skull of a patient, the two-part ICI has a first ICI-part including an electronics module, one or more stimulating electrodes electrically coupled to the electronics module and one or more current-return electrodes electrically coupled to the electronics module, the first ICI-part has a first side including the one or more stimulating electrodes and a second side opposing the first side, the two-part ICI has a second ICI-part attachable to the first ICI-part, the first ICI-part has a standard thickness K, the individualized kit comprising: a shim having an electrically insulating shim body, the shim body has a first shim-side attachable to the first side of the first ICI-part and a second shim-side opposing the first shim-side, the shim body has an effective thickness H, the shim body has one or more passages extending from the first shim-side to the second shim-side; and a second ICI-part having a first side attachable to the second side of the first ICI-part and a second side attachable to the calvarial bone, the second ICI-part has an effective thickness S, wherein the effective thicknesses H and S are specifically adapted for an individual patient so that the sum K+H+S is such that when an assembly including the first ICI-part, the second ICI-part and the shim is inserted into a through-hole made in the calvarial bone, the through-hole spanning the entire thickness of the calvarial bone, and the second side of the second ICI-part is attached to the calvarial bone, the second shim-side is in contact with at least part of a brain tissue or is in close proximity to the brain tissue, wherein the brain tissue is selected from, an outer surface of the dura matter of the patient, an arachnoid matter of the patient, an outer surface of a pia matter of the patient, and a surface of the patient’ s brain.

64. The kit according to claim 63, wherein the second ICI-part includes a permanent magnet disposed therein.

65. The kit according to claim 63, wherein the second ICI-part is selected from, a second ICI-part having a permanent magnet embedded therein, a second ICI-part having a hollow space formed therein for placing a permanent magnet therein and an openable and closable lid for closing the hollow space, a second ICI-part comprising an induction coil disposed or embedded therein, the induction coil includes two electrical contacts terminating on the surface of the first side of the second ICI-part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part, and a second ICI-part including a permanent magnet and an induction coil, the induction coil includes two electrical contacts terminating on the surface of the first side of the second ICI-part for electrically connecting the induction coil to two compatible electrical contacts disposed on the surface of the second side of the first ICI-part.

66. The kit according to any one of claims 63-65, wherein the one or more passages are selected from, one or more hollow passages for allowing electrical signals to pass through the one or more hollow passages, one or more passages at least partially filled with an electrically conducting material, one or more passages having an electrical contact mechanism attached therewithin, one or more passages having a spring-loaded electrical contact mechanism attached therewithin, one or more passages having a composite electrical contact mechanism attached therewithin the composite electrical contact mechanism includes an electrical contact mechanism and an electrically conducting material electrically connected to the electrical contact mechanism, and any non-mutually exclusive combinations thereof.

67. The kit according to claim 66, wherein the electrically conducting material is selected from, an electrically conductive metal, an electrically conductive metallic alloy, an electrically conductive polymer and an electrically conductive gel.

Images