Electrode lead

Abstract

An electrode lead is provided, having a distal side and a peripheral surface, the electrode lead comprising: a plurality of interlocking wires, the interlocking wires having a conductive core coated with a non-conductive coating; at least one three-dimensional, distinct conductive zone, the conductive zone being located at the distal end, wherein the wires in the conductive zone have exposed conductive cores, and a portion of the wires having exposed conductive cores are arranged on the peripheral surface. Spaced-apart areas of a three-dimensional pattern along or within the electrode lead, each of the spaced-apart areas being a network of spaced-apart conductive segments, the spaced-apart conductive segments together determining a critical parameter of the directionality of the area and a critical parameter of the electrical performance of the area.

Description

[0001] This application is a divisional application of an application filed on November 9, 2015, with application number 201580072511.7 and invention name “Electrode Lead”. Technical Field

[0002] The present invention relates to an electrode lead that can be used to sense or stimulate electrical impulses in tissue and a method of making the lead. Background Art

[0003] Electrical stimulation of body parts, such as the spinal cord, peripheral nerves, cranial nerves, nerve roots, muscles, or brain tissue, is used to treat a variety of conditions, including, for example, Parkinson's disease, dystonia, chronic pain, Huntington's disease, bradykinesia, epilepsy and seizures, eating disorders, and mood disorders. For those and other conditions, sensing or recording electrodes can also be used to monitor the electrical activity of the tissue being treated or studied. Many electrodes, whether stimulating or sensing, have similar properties.

[0004] Typically, an electrode for stimulation includes a flexible, axially extending probe body having a plurality of annular or other structured stimulation contacts distributed at equal or varying distances along its area. Similar electrodes can be constructed to record physiological potentials and neural activity in tissues, particularly brain tissue.

[0005] While stimulation of the electrodes is optimized based on the therapeutic outcome, more refined shaping of the electric field formed by the electrodes is required, which in turn will shape the activation field (the activation field is the actual area in the brain that is being affected by neurons being activated and or inhibited by the generated electric field). By directing the activation field to the desired tissue area and limiting the extension of the activation field from other areas, better optimization can be performed, while increasing the therapeutic benefit to the patient and reducing the side effects that come from stimulation that is performed only along the electrode lead and not in a direction perpendicular to the lead axis using current technology. Optimizing the shape of the activation field requires, among other things, increasing the number and resolution of the electrode contacts in order to increase the resolution of the activation field that can be achieved. Therefore, the directionality of the electrode contacts is very important.

[0006] Electrodes currently available on the market contain a limited number of contacts; these electrodes are assembled manually or in a semi-automatic manner. Future approaches involve other methods of making electrode leads, such as photolithography, electroforming, laser ablation, etc., to accurately manufacture electrode arrays with finer contacts and a higher number of contacts. However, these methods are cumbersome and relatively long steps, generally with a limited and essentially two-dimensional surface. As the contact surface becomes smaller, the area in contact with body fluids or body tissues also becomes smaller, and the electrical performance of the electrode becomes weaker (for example, the impedance of the contact increases), resulting in potentially high current densities that may be harmful. It is extremely difficult to prepare arrays of small electrodes with complex shapes having a large amount of conductive surface, especially to prepare asymmetric arrays that are crucial in treating the above-mentioned conditions.

[0007] US Patent No. 5,330,524 discloses an implantable cardiac defibrillation electrode comprising a mesh of conductive wires formed from intersecting helically wound cables. Each helically wound cable comprises a plurality of stranded wire elements having a central wire element and a plurality of outer wire elements wound adjacent to the central wire element. This electrode does provide flexibility and a large contact surface area; however, the mesh described in US Patent No. 5,330,524 is generally conductive and not sufficiently directional or region-specific for some applications.

[0008] Another example is described in U.S. Patent 8,923,984 to Parker et al. This disclosure depicts a neurostimulator made of knitted electrodes. In this case, because the conductive filaments are intertwined within the non-conductive filaments, there is the potential for more specific contact areas. In addition to other drawbacks of the disclosed structure, the knitted electrodes have relatively large spacing between adjacent rows, which effectively prevents precise and stable positioning of the electrodes within the often very small desired area.

[0009] On the other hand, the present invention is directed to addressing more specific needs for controlling the size and positioning of very small contacts of an electrode lead according to aspects of the present invention, as well as its critical performance, its directionality, and its electrical performance (e.g., impedance). The electrode lead according to the present invention is easy and precisely manufactured. Summary of the Invention

[0010] Therefore, according to one aspect, there is provided an electrode lead having a distal end side and a peripheral surface, the electrode lead comprising:

[0011] a plurality of interlocking wires having a conductive core coated with a non-conductive coating;

[0012] At least one three-dimensional, distinct conductive mass is located at the distal end, wherein the filaments in the conductive mass have exposed conductive cores, and a portion of the filaments with exposed conductive cores are arranged on the peripheral surface.

[0013] Therefore, according to one aspect, there is provided an electrode lead having a distal end side and a peripheral surface, the electrode lead comprising:

[0014] The spaced-apart regions of the three-dimensional pattern along or within the electrode lead are each a network of spaced-apart conductive segments that together determine critical parameters of the directionality of the region and critical parameters of the electrical performance of the region.

[0015] According to another embodiment, the conductive core of the wire in the conductive region extends to the proximal end of the electrode lead and is connected to the electronic module.

[0016] According to another embodiment, the interlocking filaments are interlocked using a method such as braiding, knitting, weaving, intertwining, tangling or netting.

[0017] According to another embodiment, the plurality of interlocking filaments are arranged in layers.

[0018] According to another embodiment, the layers are axial.

[0019] According to another embodiment, an electrical signal can be transferred to the electronic module via the conductive area, or an electrical signal can be transferred from the electronic module via the conductive area.

[0020] According to another embodiment, the electrode lead is provided with at least one insert located between the layers comprising the electrode lead, the wire passing through at least one slot in the insert at an angle relative to the longitudinal axis of the electrode lead.

[0021] According to another embodiment, the wire is severed at the circumferential surface.

[0022] According to another embodiment, the insert can be positioned innermost.

[0023] According to another embodiment, the insert extends only partially in the electrode lead.

[0024] According to one aspect, a method for preparing an electrode lead is provided, the method comprising:

[0025] providing a machine capable of interlocking multiple filaments into a three-dimensional structure;

[0026] providing a plurality of wires, wherein a portion of the wires are non-conductive wires, and another portion of the wires include a conductive core coated with a non-conductive coating;

[0027] providing a laser capable of radiating a laser beam toward the filament during interlocking;

[0028] interlocking the plurality of filaments according to a predetermined program to form the three-dimensional structure;

[0029] During the interlocking of the plurality of wires, the laser beam is irradiated toward one of the other part of the wires so as to expose the conductive core.

[0030] According to another embodiment, the three-dimensional structure is an electrode lead as described above.

[0031] According to another embodiment, the method further comprises providing a dispenser capable of directing a material toward the wires during interlocking and capable of dispensing the material to the plurality of wires during interlocking the plurality of wires.

[0032] According to another embodiment, the machine is provided with a hollow cylinder for interlocking the three-dimensional structures.

[0033] According to another embodiment, the barrel is provided with at least one slit through which an additional wire can be transferred from the hollow to the three-dimensional structure outside.

[0034] According to another embodiment, the method further comprises pulling the additional wire from the hollow through the slit in a direction opposite to the direction in which the plurality of wires are interlocked.

[0035] According to another embodiment, the method further comprises cutting the additional wire near the peripheral surface.

[0036] According to another embodiment, the machine is provided with a braider having a rotating drum for interlocking the three-dimensional structures.

[0037] According to another embodiment, the laser is contained within the weaver.

[0038] According to another embodiment, the method further comprises providing a computing module and programming the computing module to instruct the machine according to a predetermined pattern of the three-dimensional structure.

[0039] According to another embodiment, programming the computing module includes setting parameters that establish characteristics of the electrode leads.

[0040] According to another embodiment, programming the computing module includes setting characteristics of the electrode lead, through which parameters for interlocking the plurality of wires are established. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] In this document, the present invention is described by way of example only with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is emphasized that the details shown are exemplary and are for the purpose of illustrating and discussing preferred embodiments of the present invention only, and are intended to provide a description that is considered to be most helpful and easy to understand the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show structural details of the present invention in more detail than is necessary for a basic understanding of the present invention. The description of the accompanying drawings makes it apparent to those skilled in the art how the various forms of the present invention may be embodied in practice.

[0042] The present invention will be more fully understood and appreciated through the following detailed description taken in conjunction with the accompanying drawings, in which:

[0043] While the disclosure is subject to various modifications and alternatives, details of the disclosure have been shown by way of example in the drawings and will be described in further detail below. However, it should be understood that the disclosure is not limited to the specific embodiments described. On the contrary, the disclosure covers all modifications, equivalents, and alternatives.

[0044] Figure 1a A schematic diagram of a distal portion of an electrode lead is illustrated according to an exemplary embodiment.

[0045] Figure 1b Pictured Figure 1a Schematic cross-sectional view of the electrode lead shown.

[0046] Figure 1c A schematic diagram of a distal portion of an electrode lead according to another exemplary embodiment is illustrated.

[0047] Figure 1d A schematic diagram of a cross-sectional distal end portion of an electrode lead along its axial axis is shown.

[0048] Figure 2a A method of braiding layered leads according to an exemplary embodiment is schematically illustrated.

[0049] Figure 2b A method of braiding layered leads according to another exemplary embodiment is schematically illustrated.

[0050] Figure 2c A method of braiding layered leads according to another exemplary embodiment is schematically illustrated.

[0051] Figure 2d A method of braiding layered leads according to another exemplary embodiment is schematically illustrated.

[0052] Figure 2eA method of braiding layered leads according to another exemplary embodiment is schematically illustrated.

[0053] Figure 3 A method for establishing a gap between two adjacent wires according to an exemplary embodiment is illustrated.

[0054] Figure 4 Illustrated is a diagram of a method for using a Figure 3 The contact points on the lead surface are made by the method shown.

[0055] Figure 5 A method for applying motion to a filament during a manufacturing process according to an exemplary embodiment is illustrated.

[0056] Figure 6a An apparatus for manufacturing an interlocking structure according to an exemplary embodiment is schematically illustrated.

[0057] Figure 6b A block diagram depicts a method of manufacturing an electrode lead according to an exemplary embodiment.

[0058] Figure 7a A portion of a multi-layer lead according to an exemplary embodiment is illustrated.

[0059] Figure 7b yes Figure 7a A magnified portion of the layer in .

[0060] Figure 8 A cross-sectional view through a contact of an electrode lead is illustrated according to an exemplary embodiment.

[0061] Figure 9a The figure shows a cross-sectional view of the distal end of an electrode lead according to another exemplary embodiment.

[0062] Figure 9b Pictured Figure 9a A cross-sectional view of the distal end of the electrode lead is shown after expansion. DETAILED DESCRIPTION

[0063] According to aspects and embodiments of the present invention, an electrode lead and a method for preparing the electrode lead are provided. Embodiments are intended to construct a lead made of multiple interlocking wires, wherein the multiple interlocking wires are bundled to form a lead with electrode contacts on the distal side, which can also be customized. Interlocking wires can be manufactured by plaiting, knitting, braiding, intertwining, tangling, netting or any other method for interlocking wires into a specific predetermined structure. Any other method that can interlock wires into a three-dimensional structure that can be used as an electrode is covered by the scope of the present invention.

[0064] Leads can include two types of filaments organized into layers: completely non-conductive filaments and filaments made of a conductive material coated with a non-conductive material. To form a contact surface in the lead that can transmit electrical signals into or out of the lead, a portion or section of the non-conductive coating is removed from the filament to expose the conductive material. The contact surface is a surface made up of multiple adjacent exposed areas of multiple filaments located in the outer layer of the lead.

[0065] The dimensions of the surface can be predetermined according to the actual area of ​​the body to be stimulated by the electrodes, so as to allow control of the flow of electrical signals through the surface. The dimensions of each contact can be different from the other contacts, and the dimensions of all contacts correspond to the specific needs and requirements of the specific person and condition to be treated.

[0066] It should be emphasized that the use of exposed conductive portions of the wire to form the contacts is a substantial advantage of the embodiments disclosed below over the prior art. The fact that the contacts are part of the wire results in a stable contact position, for example, the contacts cannot move relative to the lead itself and cannot fall off; the contacts are part of the interlocking structure.

[0067] Another important feature of the disclosed lead is the directionality of the electrodes. Typically, the electrode surface area faces an axis that is roughly perpendicular to the lengthwise axis of the lead. In this way, there is complete control over the electrical activity of the area in the tissue to be stimulated or monitored. As an example, in the treatment of Parkinson's disease, stimulating electrodes are positioned in deep brain tissue and are used to stimulate very specific tissue during a very specific treatment time window. Today, as an example, the lead is provided with ring electrodes at multiple peripheries of the lead, and the electrical signal is transmitted symmetrically around the lead. Therefore, the electric field is not uniquely directed at the treatment area, but the electrical signal flow surrounds the lead.

[0068] According to one aspect of the present invention, since the size of the contact surface is completely controllable and can be very small, it is possible to place more than one contact around a particular perimeter of the lead. In this way, the electrical signal is completely directed to the area to be treated without having signals directed to undesirable areas.

[0069] Therefore, reference is now made to the drawings.

[0070] Now refer to Figure 1a , Figure 1a A schematic diagram of the distal portion of a lead according to an exemplary embodiment is shown. The distal portion 12 of the lead 10 is elongated and capable of reaching distant and deep tissue or other targets in the body. Relatively small contacts 14 are discretely distributed on the surface of the lead. Contacts 14 allow electrical signals to flow through their surface to stimulate adjacent tissue or collect electrical signals as desired. A cross-sectional view in the AA plane is shown to visualize the internal structure.

[0071] Now refer to Figure 1b , Figure 1b Pictured Figure 1a Schematic cross-sectional view of the lead shown. The lead 10 shown in this figure has a hollow core 18 that can be inserted by a guide wire or similar medical device. As mentioned above, the lead is made of an interlocking network of wires. In this schematic diagram, the individual wires are not shown. The interlocking possibility of establishing the three-dimensional structure of the lead will be shown below. The wires are mainly made of conductive wires coated with insulating material. Most leads include interlocking non-conductive wires. A portion of the non-conductive wires can be entirely non-conductive wires, and a portion of the non-conductive wires can be conductive wires coated with non-conductive material. In order to form electrode contacts, the insulating non-conductive material is removed from multiple adjacent wires (this issue will be described in detail below) to form a conductive area 16 that serves as a three-dimensional contact. The multiple exposed wires in one area of ​​the conductive area 16 are isolated from each other to prevent short circuits between the wires at the distal end of the lead to form a connector contact. The wires are connected to each other at the electronic module in the proximal end of the lead to transmit electrical signals from the contacts or collect electrical information from the contacts. The electronic modules are not shown in the figures, and any modules available in the art or specific modules can be utilized without limiting the scope of the present invention.

[0072] The flow of electrical signals into and out of the conductive region 16 is possible through the outer surface area 14 of the contact, which is generally aligned with the surface of the lead 10. The directionality of the electrical signal formed in the contact is generally determined by the outer surface area of ​​the contact. The larger the conductive region 16, the better the electrical performance of the contact (e.g., the lower the impedance of the contact). Therefore, more current will flow through the surface area of ​​the contact. This feature is also important in sensing and recording electronic leads because it causes the electrode lead to exhibit a lower signal-to-noise ratio.

[0073] As mentioned above, most leads are made of interlocking filaments of insulated conductive wire, the conductive areas being the areas where the insulating coating of the wire has been removed. Thus, the possibilities are open for a wide variety of structures to be produced.

[0074] Optionally, because the conductive areas are generally completely discrete and can be made with very small surface area dimensions, it is possible to use multiple electrodes on the same lead as stimulation electrodes while using other electrodes as sensing electrodes. In this way, tissue can be treated and feedback from that tissue or adjacent tissue can be received simultaneously without having to use two separate surfaces for electrode contacts on the same lead.

[0075] The wire used for the electrode lead of the present invention is fully biocompatible with the body and is made of materials that can be implanted in the body. For the conductive core of the wire, conductive metals such as stainless steel, platinum, titanium, tungsten, iridium, cobalt alloys or combined alloys can be used. The insulating coating can be made of polymeric materials such as Parylene, silicone, polyethylene, polyvinyl chloride, polyurethane, polylactide, etc. Other materials can be used without limiting the scope of the present invention.

[0076] Now refer to Figure 1c and Figure 1d , Figure 1c and Figure 1d Schematic diagram and cross-sectional view of the distal end portion of the electrode lead according to another exemplary embodiment are respectively illustrated. According to these examples, the electrode lead 20 has a conductive area along the surface ( Figure 1c ) and extending into the electrode lead 20 ( Figure 1d ) of a plurality of three-dimensional patterns of distinct and spaced-apart regions 22 of the contact. These patterns can have a variety of surface area patterns, but the important aspect is that the directionality of the surface can be predetermined and is directly related to the lead circumferential span of the contact. Generally, as the span is lower and the surface area of ​​the contact is smaller, the electrical performance of the contact deteriorates (e.g., higher impedance); it is desirable that the electrical performance of the contact will be within certain limits in order to compensate for this degradation and produce a contact with appropriate electrical performance. According to one aspect of the invention, the contact structure is made of a volume of a conductive network comprising exposed segments of a plurality of filaments such that the total surface area of ​​the conductive elements in contact with body tissue or fluids is approximately equal to the surface area of ​​a planar contact used to produce the same electrical performance. For example, a frequently used deep brain stimulation (DBS) electrode having a cylindrical contact of 1.5 mm in length and 1.27 mm in diameter produces an impedance of approximately 500 ohms (measured in the laboratory), which is consistent with an impedance that can be calculated to be 6.123 mm 2 The contact surface area is directly related to the surface area of ​​the contact. In order to prepare a directional contact with a quarter of the surface area and the same impedance, the total surface area of ​​the contact area is required to be equal to 6.123 mm. 2 This is achieved by preparing a volumetric contact (conductive area) with spread-out conductive filaments that define the required surface area.

[0077] Now refer to Figure 2a-2e , Figure 2a-2eSchematically illustrated are various possible methods of braiding layered leads according to exemplary embodiments. To form the leads, braiding of the wire into layers is preferably used. As mentioned above, braiding is one of the methods of interlocking the structure of the lead according to the embodiments disclosed herein. The wire to be used can have a diameter as small as 8 microns, and the lead can be prepared using layers with a width of approximately one or two times the diameter of the wire. Using the methods disclosed herein, leads with relatively small diameters can be prepared. In contrast, using a new technology, three-dimensional printing, the possibility of constructing electrode leads with diameters in the range of 100 microns is conceivable. Using braiding technology, leads with smaller diameters can be prepared, which can be used in a very precise manner for different applications that can be demonstrated by today's leads.

[0078] Figure 2a A first simplified axial pattern is shown. Transverse wires 102 extend from left to right to create layers arranged around the longitudinal axis. Braiding wires 107 braid the transverse wires 102 together into a braid pattern well known in the braiding art. The width of the layer is twice the maximum diameter of the wire.

[0079] Figure 2b Another braided axial pattern is shown, in which the braiding filaments 107 each pass over two transverse filaments 202 and, when passing under a transverse filament, over one filament; and so on. This pattern can be woven on the side opposite the layer. The braiding filaments 107 can pass under two transverse filaments 102 and then immediately pass over one transverse filament 102. Any combination of these patterns is possible. In this case, the width of the layer is also twice the maximum diameter of the filaments.

[0080] Figure 2c A method for obtaining another pattern in two layers is shown: Figure 2a The first layer of the simplified braided structure shown is formed by braiding together the transverse wires 102, for example, by braiding wires 107, and another layer can be formed in the same manner; however, in Figure 2c In the pattern shown, the two layers are interlocked together at temporary exchange points 204. It can be seen that the pattern does not necessarily form an axial structure, but rather a flat structure.

[0081] Figure 2d Another example of a braid profile is shown, which is axial. The transverse filaments do not follow a transverse path; instead, they extend in a helical pattern 102 around the longitudinal central axis. Braiding filaments 107 present a helical reverse pattern that interlocks with the helical pattern 102 of the transverse filaments. This braid pattern can provide stretchability along the longitudinal central axis of the lead and can provide greater flexibility.

[0082] exist Figure 2e In the figure, it is shown that the Figure 2b and Figure 2c The structure of the structure shown. Transverse wire 102 has established more than two layers (in this particular example, three layers have been established), and the use of braided wire 107 can make each layer present a specific pattern. All layers can be interlocked, and even distant layers can have exchange points 207 and exchange points 205 located between adjacent layers. In the example shown in the figure, if we follow a specific wire-wire 206 from the middle layer, it can be seen that at the exchange point 205 that interlocks the upper layer with the middle layer, the wire 206 will exchange the layer from the middle layer to the upper layer. Further following the wire 206 to the right, at the exchange point 207, the wire 206 is exchanging the layer from the upper layer to the lower layer.

[0083] Such exchange points between layers in the structure can form a lead with an integrated layer that creates a three-dimensional structure that is strong and can withstand high applied pressures. According to one aspect of the present invention, the conductive area is present at the distal end of the lead and occupies a portion of the volume of the conductive area and the surface area of ​​the outer periphery of the lead. When using exchange points, when designing the layers, whether the filaments progress from surface area to volume or vice versa in the layer, it should be ensured that each filament can include an exposed area with conductive characteristics.

[0084] Many other patterns can be produced using the methods described in this disclosure. It should be understood that any pattern that can be produced according to the methods described herein and other methods known in the art is covered by the scope of the present invention, and the patterns shown herein are not intended to limit the scope of the present invention.

[0085] It should be mentioned that all those patterns and other patterns are formed on a support frame or are formed using support elements that are not shown in these figures and at least some of which will be shown in the exemplary embodiments below.

[0086] One advantage of the method for constructing a three-dimensional structure with wires as disclosed herein is the possibility of determining and controlling the gaps between the braided wires. The gaps between the wires can be equal throughout the lead and can be different in different areas of the lead. As an example, the gaps between the wires can be larger in the proximal portion of the lead and smaller in the distal portion where the conductive area is formed. The gaps between the wires provide strength and stability to the lead and to the conductive area having surface area at the periphery of the lead. In addition, the gaps between the wires enhance the flow of electrical signals into and out of the conductive area and primarily contribute to an increase in the effective surface area of ​​the contacts without reducing the directionality of the electrical signals.

[0087] In order to form a sufficiently stable and strong three-dimensional structure, the gaps between the filaments should be controllable. According to the method of the present invention, as will be explained below, a full control of the preparation process is achieved.

[0088] Now refer to Figure 3 , Figure 3 The diagram shows a method for establishing a gap between two adjacent wires according to an exemplary embodiment. As already mentioned, a support frame or support structure is advantageous for the method for building a three-dimensional structure. The supporting hollow cylinder 300 is provided with a slit-shaped opening 302, which passes through the longitudinal axis of the cylinder and connects the hollow part of the cylinder with the outside of the cylinder. The supporting cylinder is an insert 300, which is helping to establish a gap with the outside of the cylinder. Figure 2a and Figure 2b The axial construction of the same pattern as disclosed herein is performed. The filaments are layered onto the barrel 300, one after the other, as desired. In this case, the gaps between the braided filaments 304 are considered. Along the barrel's longitudinal axis, a seam 302 is maintained, where the seam is made very narrow to allow the filaments to pass through it. Within the hollow portion of the barrel, a group of filaments 306 extends through both ends of the barrel. The length of the insert can vary.

[0089] During the braiding of the braided wire 304, one or more wires 308 housed in the hollow portion are pulled through the slits and in a direction opposite to the direction in which the braided wire is advanced. After each winding or multiple windings of the braided wire 304, the wire 308 is pulled out of the hollow portion and the braided wire is compressed backwards and toward the previous winding of the wire. Using this embodiment, the windings of the braided wire are fully compressed one toward the other with a gap in between, and the gap can be determined by the strength of the pulling or compressing action of the wire 308.

[0090] Optionally, pins or other elements can be positioned in a predetermined pattern on the outer surface of the barrel to form a predetermined gap between adjacent wires.

[0091] Optionally, the seam structure can include multiple seams, or seams that do not necessarily extend parallel to the lead axis, the purpose of which is to define where the braided inner filaments located at the periphery of the lead extend. Additionally, interlocking the filaments together will produce a final cross-section that matches the cross-section of the seam structure, one reason being that all the inner filaments are contained within the seam structure during braiding and only extend when the inner filaments are turned.

[0092] The ability to control the gaps between the wires is helpful in some cases, for example, when a 2D structure is being constructed. There are many cases where the electrode leads should correspond to specific body parts in the human body, such as retinal prostheses, for example. Although the retina is also a 2D structure, it forms a three-dimensional structure due to its curvature characteristics. In order to form this three-dimensional structure, such as Figure 2c 2D structures like the one shown are constructed with gaps that can then facilitate bending of the structure into a three-dimensional structure.

[0093] It should be added that bending the flat structure can be performed in other ways without limiting the scope of the invention. In another way, the layers can be woven flat and thereafter can undergo specific treatments that deform them into the three-dimensional final structure.

[0094] Alternatively, another approach is to braid a flat lead through multiple layers that are deformed by heat. The lead is heated using a thermal image, such as a holographic laser image or a holographic IR image, projected onto the lead. The lead then takes on the final shape from the image, depending on the desired final form. This can also be done iteratively, where a thermal image can be projected onto the braided lead, causing a slight deformation. Then, another image can be projected, causing another slight deformation. This process is repeated until the final desired shape is achieved. Other deformation methods are possible.

[0095] Back to Figure 3 , it is also possible to form the contact surface using wire 308, which remains extended from the structure after being wound around the braided wire 304. In this case, the wire used as the pressure wire 308 must be made of a conductive wire coated with an insulating material. The wire is cut to form the contact point on the surface of the lead.

[0096] Now refer to Figure 4 , Figure 4 Illustrated is a diagram of a method for using a Figure 3 The contact points on the lead surface are made by the method shown. The lead 400 is made using Figure 3 The lead 400 is made according to the method explained above. For reasons of convenience, only the braided wire 402 is shown, and only one layer is present. The transverse wires are not visible. A relatively constant gap 404 is provided between the windings of the braided wire 402. As explained, according to some features of the method, the pressurized wire extending from the surface is cut so that the inner conductive cross-section 406 of the pressurized wire is exposed at the surface of the lead 400. Those contacts can be as small as the diameter of the conductive core or cores of the wire.

[0097] According to the method of the present invention, the contact area forming the electrode in the lead is formed by removing the non-conductive coating of the wire and exposing the conductive material. One method of doing this is to ablate the non-conductive material of the wire using a laser beam. This method can be applied to various other actions that should be performed on the wire.

[0098] Now refer to Figure 5 , Figure 5 A method for applying an action to a filament during a build process according to an exemplary embodiment is illustrated. For example, actions that can be applied to the filament during processing for the purpose of controlling conductivity are actions such as filament cutting, gluing, welding, ablation, material deposition, or injection of an insulating material such as a gel, glue, or polymer. Figure 2a The method shown in the figure is carried out, and the horizontal wire 102 is interlocked with the braided wire 107. This is performed on the support rod 500. As an example, a machine such as a braider (not shown in the figure) is provided with and connected to a laser head 601. The laser head 601 is sending a laser beam 602 according to a preset program to ablate the non-conductive material of the conductive wire, or is sending energy enough to cut the wire so that the conductive core of the wire is exposed. In the same way, the machine can be provided with a dispenser injection needle of glue, isolation gel or other material, wherein the dispenser can inject the required amount of glue for bonding the wire, or the required amount of isolation gel is used to form an isolation area in the lead. Similarly, welding can be applied to the wire. In the case of distributing glue or isolation material to the structure, additional laser beams or lighting can be provided to the preparation machine so that the glue is activated and cured around the wire in a precise place.

[0099] Due to the extremely precise ablation of non-conductive material from the conductive core of the filament during treatment as previously described, relatively small electrodes can be prepared in specific desired areas of the lead corresponding to the treatment needs. As indicated above, in the example of Parkinson's disease, it is extremely important to be able to direct electrical signals to very specific areas in the patient's brain tissue. Because the electrodes prepared according to the disclosed method are very small and can be manufactured in any area of ​​the lead, the size and positioning of the treatment specific to a particular patient can be customized. These features represent the ability to place more than 1-2 contacts so as to significantly improve the resolution of the treatment. These features are not present in any electrode currently used or disclosed in the prior art.

[0100] According to another aspect of the present invention, a system configured to allow for the fabrication of interlocking structures is provided.

[0101] Now refer to Figure 6a , Figure 6aSchematically illustrates an apparatus for manufacturing an interlocking structure according to an exemplary embodiment. Apparatus 600 comprises an instruction module 602 programmed with at least one weaving program and a weaver 604 operatively connected to instruction module 602. Instruction module 602 controls the weaver 604 and the operation of the program by which weaver 604 weaves a three-dimensional structure. Instruction module 602 can be connected to or integrated with a computing device or module that can be provided with a plurality of programs for preparing a common electrode lead, and a default program can also be provided. Instruction module 602 or an integrated computing device can also be provided with a predetermined program that is constructed for a specific purpose and for a specific patient. Each patient may have different physical characteristics, and therefore, preparing a specific lead for a specific patient can enhance treatment in a significant manner.

[0102] The instruction module receives instructions from dedicated software that determines the characteristics of the structure to be constructed. Characteristics to be determined include, for example, the pattern or patterns to be used, the type of wire, the number of layers, the interlocking between layers, the total number and size of contacts, the gaps between wires to be used, the addition of spacers to the contacts, the examination of a specific patient for whom specific parameters should be extracted, the application of spacer material, the type of electrode, etc. In accordance with the method of manufacturing a lead of the present invention, it should be emphasized that the process is fully computerized, making it easy to design and manufacture both industrial and custom electrode leads using dedicated software that instructs the manufacturing machine.

[0103] The braiding machine 604 has a cylindrical core 606 around which filaments 608 are wound. A bobbin 610 provides the filaments to be engaged with the cylindrical core 606, which rotates to receive the filaments. The transverse filaments are placed in place using a plurality of arms 614 disposed on either side of the cylindrical core 606, roughly parallel to the core and surrounding the core. To simplify the diagram, only a few arms and even fewer transverse filaments are shown; however, the number of arms surrounding the cylindrical core can be very high, and the number of arms used when preparing a particular electrode lead depends on the total amount of transverse filaments required for that particular lead. Each arm has an opposite arm located on the other side of the cylindrical core 606. The arms 614 are extendable, and each arm can hold one end of a transverse filament at its free end. The movement of the arms is controlled by a program in the instruction module 602. For example, the program determines whether, as the cylindrical core 606 rotates, a particular transverse filament engaged with the right arm will be covered by the braiding filament 608, while the filament engaged with the left arm will not be covered and will be placed above the braiding filament. Thus, an interlocking structure of filaments is formed. The pattern possibilities are vast and would be input into the program in the instruction module 602.

[0104] As indicated above, silk is non-conductive, yet a large amount of silk is made of conductive core or wire with insulating coating. In order to form electrode and its contact surface, a part of non-conductive coating is removed. For this reason, braiding device 604 preferably includes high-power laser 616, and high-power laser 616 can ablate non-conductive coating from silk, so that the conductive material that can be used as electrode is exposed. Again, the area of ​​non-conductive coating is predetermined to be removed according to the activity program of input instruction module 602. Preferably, laser 616 is attached to tubular core 606, or at least rotates relative to arm 614. In this way, along with the rotation of tubular core 606, each root silk around the periphery of tubular core can be exposed to laser beam 618 from laser 616.

[0105] Optionally, the apparatus 600 is provided with more than one laser, which may be synchronized with another laser or may be independent or may serve as a backup.

[0106] Optionally, when one arm 614 holds a transverse filament 612 programmed to be exposed to the laser beam, the transverse filament is positioned close to where it rests on the cylindrical core 606 when exposed. Thus, the filament in this position is substantially perpendicular to the cylindrical core and is the only filament in the path of the laser beam. In this way, minimal, if any, other filaments are exposed to the beam, and the exposed area of ​​the filament is of extremely small and precise dimensions, with the exposed area of ​​the filament being consistently defined.

[0107] Note that in FIG6 , laser 616 is located on the right-hand side of cylindrical core 606, so the filament is exposed on the side of the filament facing cylindrical core 606. In this case, the exposed or conductive area of ​​the filament will be on the inside of the layer being built. In some embodiments, the laser can be located on the left-hand side of the core, and in this way, the exposed portion is on the outside of the layer being formed. Optionally, there are lasers on both sides of the core, allowing contacts to be formed on both the inside and outside of the interlocking structure.

[0108] Optionally, information about Figure 5 Dispensers similar to those disclosed and described enable the placement of glue or insulating material into a wire or braided structure during processing of an electrode lead.

[0109] Optionally, other components can be used to remove the insulating coating and expose the conductive material from the inside. Any other components are covered by the scope of the present invention and are not meant to limit the present invention.

[0110] After a layer is formed on the cylindrical core, another layer is optionally formed on top of it. To this end, an interlocking layer can be left in the braider 604, and another layer can be braided on top of the interlocking layer to make a multi-layer interlocking lead. Multiple layers can be formed one on top of the other in this manner. The top or inner layer can be left uncovered on the inside or outside to help isolate the lead from tissue that should not be stimulated or sensed (depending on the tissue and application).

[0111] Upon completion of the braiding process, the interlocking structure comprising leads having conductive areas having contacts located on the surface of the leads is removed from the device 600 and connected to appropriate circuitry so that the conductive areas can serve as electrodes for power signal transmission.

[0112] Now refer to Figure 6b , Figure 6b A block diagram depicts a method for manufacturing an electrode lead according to an exemplary embodiment. As mentioned above, according to one aspect of the present invention, a preparation machine 650 is preparing an interlocking structure made of silk. Preparation machine 650 can be a weaving machine, a sewing machine, a knitting machine, or any other machine capable of interlocking silk into a predetermined structure. To predetermine the structure of the electrode lead to be prepared in the machine, a calculation module 652 is provided. Calculation module 652 is capable of calculating information received from multiple sources and transmitting the results to instruction module 658, which in turn activates machine 650 to prepare the final product according to the instructions. Instruction module 658 instructs the machine to operate in a specific manner, moving components from one location to another according to a specific program, so that the silk interlocks in a predetermined manner. In addition, instruction module 658 also provides instructions to laser instructions 664 to ablate the silk and expose conductive material in a predetermined area of ​​the silk, which will be precisely placed in a conductive area (surface or volume). In a similar manner, the material should be arranged in predetermined areas of the three-dimensionally formed structure, for which instructions from the instruction module will be transmitted 662.

[0113] Optionally, some of the units can work together or can be integrated into a single unit or module.

[0114] The program performing the calculations in the calculation module 652 receives information from at least two sources: information 654 from known and predetermined configuration programs known in the industry. Another source is a customization source 656, from which the calculation module 652 should prepare a customized electrode lead. Examples of the information required here can include information regarding the required resolution of the electrode, the size of the contact surface relative to the tissue orientation and the overall surface of the exposed area, the required electrical properties of the contact area, the flexibility of the lead, etc.

[0115] Now refer to Figure 7a and Figure 7b , Figure 7a and Figure 7b A portion of a multi-layer lead according to an exemplary embodiment is illustrated in detail. Figure 7a The diagram shows a portion of a lead made using an apparatus such as that disclosed in FIG6 . This portion of the lead 700 includes three layers, 702a, 702b, and 702c, with 702a being the outermost layer of the lead. The layers shown in the diagram are greatly simplified to facilitate understanding of the structure. Figure 7b In Figure 1, the structure of the filaments within the layers is better seen. Multiple transverse filaments 704 are interlocked with braided filaments 706. As previously explained, a portion of the transverse filaments is ablated before interlocking into the structure. As a result, a portion of the transverse filaments 704 is conductive filament 708. In this particular case, it can be seen that all layers have the same filament organization, and because the exposed portion of conductive filament 708 extends over four adjacent braided filaments 706, the length of this portion is approximately four times the diameter of the filament.

[0116] Figure 7b The conductive lines 708 shown in the outermost layer 702a correspond to Figure 1b The surface area of ​​the contact 14 shown, the conductive line in the layer below the conductive line 708 corresponds to Figure 1b Conductive region 16 is shown.

[0117] It should be noted that the interlocking structure formed using the methods described herein is flexible. This presents the ability of the distal end of the electrode lead to follow the target area in a manner superior to existing electrodes. Because the electrode leads are subject to similar flexures and movements, the interlocking structure made of wire according to an embodiment of the present invention also has a longer fatigue life. The stress level of the smaller structure is greatly reduced. In addition, each wire is redundant, thereby allowing continued function even if the wire breaks. The interlocking structure allows a larger amount of electrode surface area to be exposed to the target area, thereby reducing the current density at the electrode / tissue interface.

[0118] As this article about Figure 5 As mentioned, a dispenser can be added to the apparatus for adding sufficient material during the manufacturing process.

[0119] Now refer to Figure 8 , Figure 8A cross-sectional view through the contacts of an electrode lead according to an exemplary embodiment is illustrated. Electrode lead 800. A conductive area 804 made of a plurality of interlocking and exposed filaments is provided. The periphery of conductive area 804 is provided with a plurality of isolation points 806, which are also provided on the periphery of electrode lead 800 itself. This feature of providing isolation points is possible due to the method for using a machine to make the structure so that the filaments are interlocked during processing, material can be added to the structure, and action can be applied to the filaments. Since the process is fully computerized, the exact location of the filament or structure to which the material should be distributed is determined, and therefore, the positioning of such isolation points is precise.

[0120] The need for isolation points creates an electrode lead structure that includes interlocking wires. As already mentioned, interlocking wires that include conductive areas have exposed conductive portions. When the electrode lead is placed in the body, bodily fluids can enter the structure and potentially generate electrical signals that travel internally within the lead. Placing isolation points between the contacts and the non-conductive area prevents this phenomenon.

[0121] Another use of such a point can be to form a conductive path between two different contacts. This may be desirable when a return current is required. For example, in the case where some of the lead contacts are connected to different current sources at the proximal end of the lead, if the total current generated is not equal to zero, one lead contact can be internally connected to the return electrical ground, which serves as a sink for all excess current.

[0122] Now refer to Figure 9a and Figure 9b , Figure 9a and Figure 9b The figure shows a cross-sectional view of the distal end of an electrode lead according to another exemplary embodiment. The distal end of the lead 900 is surrounding an expandable stent 902. A conductive area 901 is also provided at the distal end. Since the lead diameter should be small during implantation so that it can be easily and safely inserted into the correct target site after implantation, as an example, the diameter of the distal end of the lead can be expanded, and the distal end of the lead can be expanded as required and when required, so this electrode lead can be beneficial during lead implantation. In a deep brain stimulation electrode, as an example, it can be expected that the lead diameter is less than 0.8mm during implantation and about 1.3mm after implantation. In this example, the network of interlocking structural wires of the lead is formed to be able to expand and contract along the longitudinal axis of the lead, and the diameter of the network is expanded as described in an earlier embodiment of the present invention. This exemplary electrode lead allows the lead to be implanted when the diameter of the lead at the distal end is the smallest, and once the lead is implanted, the distal end will increase due to the force applied by the stent to obtain the distal end as shown. Figure 9bThe longer diameter is shown. It can also be seen that as the distal diameter increases, the surface area of ​​the lead increases. It is also possible to maintain the total surface area of ​​the contact during expansion.

[0123] It should be noted that other expansion mechanisms, such as a balloon, can also be used to expand the electrode lead diameter without limiting the scope of the present invention.

[0124] It should be noted that since the electrode lead of the present invention is to be implanted in the body, the materials comprised of the electrode lead should be MR compliant and should withstand the MRI environment. In addition, since the electrode lead of the present invention is made of interlocking wires that run along the axis of the lead, while other configurations run in different directions, the electrode lead can be constructed with an electromagnetically compatible wire configuration. This is achieved by constructing wires with conductive cores running in opposite directions in specific loops. The conductive cores eliminate interference with electromagnetic fields such as MR while reducing radiated transmission from the lead.

[0125] Optionally, regular rings or other electrodes can be combined within the structure of the electrode lead according to the present invention without limiting the scope of the invention.

[0126] Optionally, if one wants to use sensing and stimulation electrodes together, the two can be combined in a single conductive region, with several wires being used for the sensing electrodes and other wires being used for the stimulation electrodes.

[0127] It should be emphasized that although braiding of filaments is chosen as an exemplary embodiment for interlocking filaments in this disclosure, it should be understood that other interlocking methods are within the scope of the present invention and are not meant to limit the scope of the present invention.

[0128] It should be understood that the above description is intended to be illustrative, not restrictive. For example, the above embodiments (it and / or aspects) can be used in combination with each other. In addition, without exceeding the scope of the present invention, many modifications can be made to adopt specific situations or materials to the technology of each embodiment of the present invention. Although the size and type of the materials described herein are intended to limit the parameters of each embodiment of the present invention, the embodiments are not meant to be limiting, but rather exemplary embodiments. By reviewing the above description, many other embodiments will be apparent to those skilled in the art.

[0129] This written description uses examples to disclose various embodiments of the invention and also to enable any person skilled in the art to practice the various embodiments of the invention, including making and using any devices or systems and performing any included methods. The patentable scope of the various embodiments of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if the examples have structural elements that do not differ from the literal text of the claims, or if the examples include equivalent structural elements with insubstantial differences from the literal text of the claims.

[0130] Although the present invention has been described in conjunction with specific embodiments thereof, it will be apparent that many alternatives, modifications, and variations will be apparent to those skilled in the art. Therefore, it is intended that all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims be encompassed. Furthermore, citation or identification of any reference in this application shall not constitute an admission that such reference is available as prior art with respect to the present invention.

[0131] The scope of the present invention is defined by the appended claims and includes both combinations and subcombinations of the various features described above, as well as modifications and variations thereof, which will occur to persons skilled in the art upon reading the foregoing description.

Claims

1. A method for producing an interlocking structure for an electrode lead, characterized in that, include: a) providing a machine capable of interlocking a plurality of wires into said interlocking structure; b) providing a plurality of wires, at least one wire of the plurality of wires comprising a conductive core coated with a non-conductive coating; c) providing one or more laser heads, which are capable of irradiating a laser beam toward at least a portion of at least one of the plurality of wires during interlocking to ablate the non-conductive coating and form contact points, the contact points being located on the inner side and / or the outer side of the layer of the interlocking structure being constructed; d) providing a computing module and programming said computing module to instruct said machine according to a predetermined pattern of said interlocking structures; e) interlocking the plurality of wires according to a predetermined program to form the interlocking structure; as well as f) applying an action to at least a portion of the area of ​​at least one of the plurality of wires during the interlocking period to control the conductivity of the wire.

2. The method according to claim 1, characterized in that The interlocking structure is a three-dimensional structure.

3. The method according to claim 2, characterized in that The interlocking structure is a three-dimensional electrode structure.

4. The method according to claim 1, characterized in that: The interlocking structure is a 2D structure.

5. The method according to claim 2, characterized in that: The interlocking structure is a 2D electrode structure.

6. The method according to claim 1, characterized in that The step of applying an action to at least a portion of the area of ​​at least one of the plurality of wires comprises at least one of wire cutting, bonding, welding, and ablation.

7. The method according to claim 1, characterized in that The method further includes providing a dispenser capable of directing a material toward the wires during interlocking and capable of dispensing the material to the plurality of wires during interlocking the plurality of wires.

8. The method according to claim 7, characterized in that The dispenser is configured to dispense a material selected from the group consisting of glue, gel, polymer, and release material.

9. The method according to claim 1, characterized in that: The interlocking structures are flat leads.

10. The method according to claim 1, characterized in that The step of applying an action to at least a portion of the area of ​​at least one of the plurality of wires includes deforming by heating using a thermal image projected onto the interlocking structure.

11. The method according to claim 1, characterized in that: The interlocking structure is an electrode lead having a circumferential surface, the electrode lead extending along a length axis and including at least one three-dimensional different conductive area, the at least one three-dimensional different conductive area being made of a plurality of interlocking wires arranged in a multi-layer configuration, the layers being arranged radially outward from the length axis and including an outer layer and an inner layer; and the wires in the conductive area having an exposed conductive core, a portion of the wires having the exposed conductive core being arranged on the circumferential surface.

12. The method according to claim 1, characterized in that The programming of the calculation module comprises: setting characteristic parameters for establishing the interlocking structure, or setting the characteristics of the electrode structure, and establishing the parameters for interlocking the multiple wires through the characteristics of the electrode structure.

13. The method according to claim 1, characterized in that The interlocking comprises at least one of the following methods: braiding, knitting, weaving, intertwining, tangling or netting.

14. The method according to claim 11, characterized in that The electrode lead also includes spaced-apart regions of a three-dimensional pattern along or within the electrode lead, each of the spaced-apart regions being a network of spaced-apart conductive segments that together determine critical parameters of the directionality of the region and critical parameters of the electrical performance of the region.

15. The method according to claim 11, characterized in that The electrode lead is provided with at least one insert located between the layers comprising the electrode lead, and the wire passes through at least one slit in the insert at an angle relative to the longitudinal axis of the electrode lead, and the wire is cut at the peripheral surface.

16. The method according to claim 1, characterized in that The machine is provided with a hollow cylinder for the interlocking structures to interlock, and the cylinder is provided with at least one slot through which an additional wire can be transferred from the hollow cylinder to the interlocking structures outside.

17. The method according to claim 16, characterized in that The method further includes the steps of pulling the additional wire from the hollow barrel through the slot in a direction opposite to the direction in which the plurality of wires are interlocked, and severing the additional wire near the peripheral surface.

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