Nerve Stimulation Device

Abstract

The present disclosure describes an implantable lead device including an internal support comb. The support comb can include one or more faces capable of aligning, routing, and holding the internal leads of the lead device. The support comb can enable the leads to interconnect with a microelectrode membrane including electrodes of a lead device.

Description

[0001] Cross - reference to related applications

[0002] This application claims priority to U.S. Non - Provisional Patent Application No. 15 / 910,278, entitled "Neural Stimulation Device", filed on March 2, 2018, which is incorporated herein by reference in its entirety. Background Art

[0003] Deep brain stimulation (DBS) can include a neural stimulation therapy that involves an electrical stimulation system for the human brain and body. DBS can be used to treat many neurological disorders. DBS can involve electrically stimulating a target region of the brain. Summary of the Invention

[0004] The present disclosure describes a stimulation device that can be formed in a cylindrical shape. Internally, the stimulation device can include a silicon - etched support comb for aligning, routing, and holding wires. The support comb can enable the wires to be interconnected with a micro - electrode membrane that includes the electrodes of the stimulation device. The stimulation device can also include an internal support tube that can reduce mechanical displacement of the micro - electrode membrane from its epoxy molding by providing a long - edge anchoring system. The micro - electrode membrane can be wound into a three - dimensional structure to increase the degrees of freedom during assembly operations.

[0005] According to at least one aspect of the present disclosure, an implantable lead device can include a support comb. The support comb can include an attachment surface and a routing surface. The routing surface can include a plurality of grooves. The lead device can include a micro - electrode membrane. The micro - electrode membrane can include a body. The body can include a plurality of electrodes. The micro - electrode membrane can include an extension extending from the body. The extension can include a first surface. The first surface of the extension can include a plurality of electrical contacts coupled to the plurality of electrodes. The extension can include a second surface. The second surface of the extension can be coupled to the attachment surface of the support comb. The lead device can include a plurality of wires. Each of the plurality of wires can pass through a respective one of the plurality of grooves and be coupled to a respective one of the plurality of electrical contacts.

[0006] The attachment surface can include a channel to direct an adhesive under at least a portion of the second surface of the micro - electrode membrane. The first surface of the body of the micro - electrode membrane can be coupled to a support tube. The support tube can include a plurality of radiopaque markers aligned with the plurality of electrodes. The support tube can include a plurality of castellations at a first end. The first end can be configured to mate with the support comb.

[0007] The lead device can include a support tube that can include a plurality of radiopaque markers. Each wire of the plurality of wires can be coupled to a respective one of the plurality of electrical contacts using wire bonding.

[0008] The extension portion of the microelectrode membrane may include a first leg and a second leg. The first leg may include a first side of the extension portion and a second side of the extension portion. The second leg may include a plurality of traces that couple a subset of the plurality of electrodes to the plurality of electrical contacts.

[0009] The first leg and the second leg of the extension portion may be wound around a support comb. The wire device may include epoxy backfill of the microelectrode membrane to form a probe shaft.

[0010] According to at least one aspect of the present disclosure, a method of manufacturing an implantable wire device may include providing a support comb. The support comb may include an attachment surface and a wiring surface. The wiring surface may include a plurality of slots. The method may include coupling a first portion of the microelectrode membrane to the attachment surface of the support comb. The first portion of the microelectrode membrane may include a plurality of electrical contacts. The method may include positioning each of the plurality of wires to pass through a respective one of the plurality of slots in the wiring surface. The method may include coupling each of the plurality of wires to a respective one of the plurality of electrical contacts. The method may include winding a second portion of the microelectrode membrane around the support comb.

[0011] The method may include forming a second portion of the microelectrode membrane. The second portion includes a plurality of electrodes that are in electrical communication with the plurality of electrical contacts. The method may include forming a third portion of the microelectrode membrane. The third portion may include a plurality of electrical traces that couple a portion of the plurality of electrodes to a portion of the plurality of electrical contacts.

[0012] The method may include coupling the second portion of the microelectrode membrane to the outer surface of a support tube. The second portion of the microelectrode membrane may include a plurality of electrodes. The method may include molding the support comb with epoxy.

[0013] The method may include forming a plurality of radiopaque markers in the support tube. The method may include aligning the plurality of radiopaque markers with the plurality of electrodes formed in the microelectrode membrane. The plurality of radiopaque markers may be offset from the plurality of electrodes.

[0014] The method may include wire bonding each of the plurality of wires to a respective one of the plurality of electrical contacts. The method may include winding the second portion of the microelectrode membrane to form a cylinder. The method may include filling the cylinder with epoxy.

[0015] The method may include bottom filling a channel formed in the attachment surface with epoxy to couple the first portion of the microelectrode membrane to the attachment surface. The method may include etching the support comb in silicon.

[0016] The method may include coupling a first edge of the microelectrode membrane to a second edge of the microelectrode membrane to form a cylinder. The method may include inserting the first edge and the second edge of the microelectrode membrane into a slot in the support tube. Brief Description of the Drawings

[0017] The drawings are not drawn to scale. In the various drawings, the same reference numerals and names denote the same elements. For clarity, not every component is labeled in every figure. In the drawings:

[0018] Figure 1 An example system for performing nerve stimulation is shown.

[0019] Figure 2 Shows a Figure 1 stimulation lead for the system shown.

[0020] Figure 3 Shows a Figure 2 perspective view of the distal end of the stimulation lead shown.

[0021] Figure 4 Shows a Figure 2 top view of the microelectrode membrane for the stimulation lead shown.

[0022] Figure 5 Shows the microelectrode membrane in a wound configuration.

[0023] Figure 6 Shows a Figure 2 sample support tube for the stimulation lead shown.

[0024] Figure 7 Shows the microelectrode membrane coupled to the support tube as viewed from the distal end of the support tube.

[0025] Figures 8 - 10 Shows a Figure 2 sample support comb for the stimulation lead shown.

[0026] Figures 11 - 14 Shows a Figure 2 view of the distal end of the stimulation lead shown.

[0027] Figure 15 Shows a Figure 2 partial view of the interface between the support comb and the microelectrode membrane in the stimulation lead shown in .

[0028] Figure 16 Shows a Figure 2 partial view of a sample support comb that can be used for the stimulation lead shown.

[0029] Figure 17 Shows a partial view of the coupling of the support comb to the support tube.

[0030] Figure 18 and Figure 19 Shows an exemplary configuration of a microelectrode membrane with protrusions.

[0031] Figure 20 illustrates exemplary support tubes and markers for Figure 1 the system shown.

[0032] Figure 21 illustrates exemplary support combs having a circular configuration in Figure 1 the system shown.

[0033] Figure 22 illustrates an example method of fabricating a wire device for use in Figure 1 the system shown. DETAILED DESCRIPTION

[0034] The various concepts introduced above and discussed in more detail below can be implemented in any of a variety of ways, as the described concepts are not limited to any particular implementation. Examples of specific implementations and applications are provided primarily for illustrative purposes.

[0035] Figure 1 Illustrates an example system 50 for performing nerve stimulation. System 50 includes a stimulation lead 100 implanted in the brain 54 of a patient 52. The stimulation lead 100 is coupled to a stimulator 58 via a cable 56. The stimulator 58 generates therapeutic electrical stimulation that can be delivered to the patient's brain 54 via the stimulation lead 100. The stimulation lead 100 can be an implantable wire device that can be implanted in the patient 52 either long-term or short-term.

[0036] Figure 2 Illustrates the stimulation lead 100. The stimulation lead 100 includes a distal end 110 and a proximal end 112. The distal end 110 includes a plurality of electrodes 108. The proximal end 112 includes a plurality of terminal contacts 116. Each terminal contact 116 is electrically coupled to at least one electrode 108. For example, a wire (or other electrical trace) can extend from one of the terminal contacts 116 through the interior of the body 114 to a contact disposed toward the distal end 110 that is in electrical communication with the electrode 108.

[0037] Figure 3 Illustrates a perspective view of the distal end 110 of the stimulation lead 100. As an overview, the distal end 110 includes a microelectrode membrane 104 having a plurality of electrodes 108. The microelectrode membrane 104 is coupled to a support tube 132. The distal end 110 also includes a support comb 102. The support comb 102 can enable wires 106 to be attached to the microelectrode membrane 104. The distal end 110 also includes a probe shaft 140. The components of the distal end 110 are described below in connection with Figures 4 - 9 etc., and the assembled distal end 110 is further described in connection with Figures 10 - 17 etc.

[0038] The distal end 110 includes a microelectrode membrane 104. Figure 4A top view of the microelectrode membrane 104 is shown. Figure 4 The microelectrode membrane 104 having a planar configuration is shown. The microelectrode membrane 104 includes a body 120 and an extension 122. The body 120 includes a plurality of electrodes 108. The extension 122 includes a plurality of contacts 118. The contacts 118 may be coupled to the electrodes 108 via traces 124.

[0039] The microelectrode membrane 104 includes a body 120. The body 120 may include a plurality of electrodes 108. The body 120 may include between about 4 and about 64, between about 8 and about 32, between about 8 and about 24, or between about 4 and about 12 electrodes 108. The electrodes 108 may be configured as omnidirectional or directional electrodes. For example, in an omnidirectional configuration, the electrodes 108 may extend substantially the height 126 of the body 120 such that when the microelectrode membrane 104 is formed as a cylinder (as Figure 5 shown), the electrodes 108 substantially wrap around (e.g., at least 80% or at least 90%) the circumference of the distal end 110. In a directional configuration, as Figure 4 shown, the electrodes 108 extend only a portion of the height 126 of the microelectrode membrane 104. For example, in a directional configuration, the electrodes 108 may each extend between about 10% and about 80%, between about 10% and about 60%, between about 10% and about 40%, or between about 10% and about 25% of the height 126 of the body 120. The electrodes 108 may be grouped in columns to span the height 126. One or more directionally configured electrodes 108 may be electrically coupled together to form an omnidirectional electrode 108. Coupling between at least two directionally configured electrodes 108 to form an omnidirectional electrode 108 may occur electrically by connecting two traces 124 within the microelectrode membrane 104 or by connecting terminal contacts 116 via a wire 106.

[0040] The microelectrode membrane 104 may include a plurality of traces 124. The traces 124 may couple the electrodes 108 to one or more contacts 118. The microelectrode membrane 104 may include the same number of contacts 118 and electrodes 108 such that each electrode 108 is coupled to a single contact 118. The microelectrode membrane 104 may include fewer contacts 118 than electrodes 108 such that more than one electrode 108 is coupled to the same contact 118 (to form, for example, an omnidirectional electrode). Each trace 124 may make one or more connections to an electrode 108. For example, a trace 124 may branch into two or more peripheral traces that couple to the electrode 108 at several points around the periphery of the electrode 108. Making multiple connections to each of the electrodes 108 may increase the reliability of the microelectrode membrane 104.

[0041] The extension portion 122 may include the contact 118. The contact 118 may provide an interface at which the wire 106 is coupled to the microelectrode membrane 104. For example, each wire 106 may be wire-bonded or laser-bonded to a corresponding one of the contacts 118.

[0042] The extension portion 122 may include a first leg 128 and a second leg 130. The contact 118 may be disposed on a first surface of the first leg 128. The first leg 128 may further include openings 158 disposed toward each end of the first leg 128. The openings 158 may be holes extending through the first leg 128. The openings 158 may be aligned with inlets formed in the attachment surface of the support comb 102 (and are further described below in connection with the figures). The second leg 130 may include a subset of the traces 124 extending from the contact 118 to the electrodes 108. Extending a subset of the traces 124 along the second leg 130 may enable a greater number of traces 124 (and thus electrodes 108) to be incorporated into the microelectrode membrane 104 compared to a system that routes the traces 124 along a single leg. Figure 8 The microelectrode membrane 104 in a wound configuration is shown. As shown, opposite edges of the body 120 are wound toward each other to form a cylinder. The second leg 130 is wound around the first leg 128 to form a second portion of the cylinder. As

[0043] Figure 5 and Figure 5 and Figure 6 shown, the body 120 may be wound around a support tube.

[0044] Figure 6 An exemplary support tube 132 is shown. The support tube 132 may include a plurality of markers 134. The support tube 132 may include a groove 136. The proximal end of the support tube 132 may include a plurality of castellations 138.

[0045] The support tube 132 may include a radiation-impermeable metal (e.g., medical-grade stainless steel), a non-metallic material (e.g., plastic), or a combination thereof. The support tube 132 may include a plurality of markers 134. The markers 134 may be radiopaque. For example, the markers 134 are visible when the stimulation lead 100 is imaged with a CT scanner or an X-ray. When the support tube 132 is made of a radiation-impermeable metal, the markers 134 may be holes or voids in the body of the support tube 132. The markers 134 may penetrate the wall of the support tube 132. When the marker 134 is a hole that penetrates the wall of the support tube 132, the area without the marker 134 may be relatively more radiopaque compared to the portion of the support tube 132 with the marker 134. The electrode 108 may be aligned with the marker 134. The electrode 108 may be aligned with the area between the markers 134. The support tube 132 may be made of a plastic material, and the markers 134 may be made radiopaque by local doping of the polymer (e.g., boron bombardment) or by backfilling with a doped polymer (e.g., boron-doped plastic).

[0046] The support tube 132 may include a plurality of castellations 138. The castellations 138 may be a plurality of extensions extending from one end of the support tube 132. Each castellation 138 may be separated from an adjacent castellation 138 by a gap or crenellation. The length of each of the castellations 138 may be between approximately 0.2 mm and approximately 2 mm, between approximately 0.4 mm and approximately 1.5 mm, between approximately 0.2 mm and approximately 1 mm, or between approximately 0.4 mm and approximately 0.6 mm. The castellations 138 may have a circumferential pitch between approximately 0.1 mm and approximately 2 mm, between approximately 0.1 mm and approximately 1.5 mm, between approximately 0.1 mm and approximately 1 mm, between approximately 0.1 mm and approximately 0.5 mm, or between approximately 0.2 mm and approximately 4 mm.

[0047] The castellations 138 are configured to cooperate with the support comb 102. The castellations 138 are configured to cooperate with the probe shaft of the stimulation lead 100. The probe shaft may be formed by an epoxy overmolding process. The castellations 138 may provide grooves and ridges into which the epoxy may flow and bond to form the probe shaft.

[0048] The support tube 132 may include a groove 136. The groove 136 may extend along the length of the support tube 132. The groove 136 may penetrate the wall of the support tube 132 or may form a channel in the outer surface of the support tube 132.

[0049] Figure 7Shows the microelectrode membrane 104 coupled to the support tube 132 when viewed from the distal end of the support tube 132. The first side of the body 120 including the electrode 108 can face outward and away from the support tube 132. The second side of the body 120 of the microelectrode membrane is coupled to the outer surface of the support tube 132 to form a cylinder. The opposite edges of the body 120 are inserted through the slots 136.

[0050] Figure 8 Shows the attachment surface of the support comb 102 and the first wiring surface 144 of the support comb 102. The attachment surface 142 includes channels 148. The attachment surface 142 of the support comb 102 is configured to be coupled to the surface of the microelectrode membrane 104. The channels 148 are configured to direct adhesive beneath a portion of the surface of the microelectrode membrane 104 that is coupled to the attachment surface 142. The channels 148 can be between about 5 μm and about 40 μm, between about 10 μm and about 30 μm, or between about 10 μm and about 20 μm. During the manufacture of the stimulation lead 100, the surface of the microelectrode membrane 104 can be coupled to the attachment surface 142 of the support comb 102 by mechanical means (such as a clamp). The inlet 150 can extend beyond the portion of the microelectrode membrane 104 that is coupled to the attachment surface 142. Adhesive can be added to the inlet 150. Capillary action can transport the adhesive along the length of the channels 148 and beneath the surface of the microelectrode membrane 104 that is coupled to the attachment surface 142. Once the adhesive has cured, the mechanical means for holding the microelectrode membrane 104 to the attachment surface 142 can be released.

[0051] The support comb 102 can include a first wiring surface 144. The first wiring surface 144 can include a plurality of slots 152 (which can also be referred to as channels 152). The first wiring surface 144 can include a slot 152 for each wire 106. During the manufacturing process, each contact 118 can be substantially aligned with one of the slots 152 to facilitate coupling of the wire 106 to the contact 118. For example, each wire 106 can pass through a corresponding slot 152 to align with a different contact 118. The spacing of the slots 152 can match the spacing of the contacts 118.

[0052] Figure 9 Shows the second wiring surface 154 of the support comb 102. The second wiring surface 154 is opposite the attachment surface 142. The second wiring surface 154 can include a plurality of fingers 156. The fingers 156 are raised protrusions that can form channels 157 in the second wiring surface 154. Each channel 157 can terminate in a hole 159 that leads to a slot 152 on the first wiring surface 144.

[0053] Figure 10The second wiring surface 154 is shown, through which the wire 106 passes. The wire 106 can enter the channel 157 defined by the fingers 156. From the channel 157, the wire 106 can pass through the hole 159 at the end of the channel 157 and enter one of the corresponding slots 152 on the first wiring surface 144. The color coding of the wire 106 can enable proper wiring of the wire 106 from each of the terminal contacts 116 to the corresponding electrode 108 at the distal end 110.

[0054] Figures 11 - 14 Different views of the distal end 110 are shown. Figures 11 - 14 Each view shown shows a view of the distal end 110 of the stimulation lead 100 rotated 90 degrees relative to the previous figure. For example, Figure 11 can be said to show a top view of the distal end 110, Figure 12 can be said to show a first side view of the distal end 110, Figure 13 can be said to show a bottom view of the distal end 110, and Figure 14 can be said to show a second side view of the distal end 110. The foregoing "top", "first side", "second side" and "bottom" are provided for reference only, as any face of the distal end 110 can be used as the "top", "bottom", etc. For example, the placement of the electrodes 108 around the circumference of the distal end 110 enables any face (or angle) of the distal end 110 to be used as the top, bottom or side of the distal end 110.

[0055] Referring together Figures 11 - 14 , wherein the distal end 110 includes a microelectrode membrane 104. The microelectrode membrane 104 includes a plurality of electrodes 108. The electrodes 108 are coupled to the terminal contacts 116 via the wires 106. The distal end 110 also includes a support comb 102. The support comb 102 can facilitate the management of the wire 106 within the axis of the distal end 110. The support comb 102 can also fix or hold the termination ends of the wire 106 near the contacts of the microelectrode membrane 104. Positioning the termination ends of the wire 106 near the contacts of the microelectrode membrane 104 can achieve improved efficiency in manufacturing, as the support comb 102 can provide alignment between the wire 106 and the contacts 118 of the microelectrode membrane 104.

[0056] Figure 15 An enlarged view of the interface between the support comb 102 and the microelectrode membrane 104 is shown. Figure 15 The microelectrode membrane 104 in a wound or cylindrical configuration is shown. The extension 122 of the microelectrode membrane 104 is wound around the support comb 102 such that the support comb 102 is located within the cavity defined by the wound (or cylindrical) microelectrode membrane 104. The second leg 130 is wound around the support comb 102 and towards the second wiring surface 154 of the support comb (at Figure 15positioned (shown in the back of the support comb 102). The first leg 128 can be coupled to the attachment surface 142.

[0057] The first leg 128 of the microelectrode film 104 can be coupled to the attachment surface 142. The first leg 128 can include a first surface and a second surface opposite the first surface, the first surface including the contact 118, and the second surface can be coupled to the support comb 102. The second surface can be coupled to the attachment surface 142. The first leg 128 can be positioned on the attachment surface 142 such that the opening 158 is substantially aligned with the inlet 150. For example, before winding the extension 122 around the support comb 102, the adhesive can be delivered to the inlet 150 through the opening 158 in the first leg 128. By capillary action, the adhesive can flow through the channel 148 and flow under the first leg 128 to couple the first leg 128 (e.g., the second surface of the first leg 128) to the attachment surface 142.

[0058] By connecting the first leg 128 to the attachment surface 142, the contact 118 can be substantially aligned with the slot 152. The contact 118 can be offset from the slot 152. For example, each contact 118 can be positioned between adjacent slots 152. The slots 152 can enable wire management and position the wire 106 in the correct position to engage the contact 118. For example, the wire 106 can pass through each slot 152 to align with one of the contacts 118. The wire 106 can be coupled to the contact 118. The wire 106 can be wire bonded or soldered to the contact 118.

[0059] Figure 16 An enlarged view of the support comb 102 is shown. Figure 16 Basically shown Figure 15 the back (and the distal end 110) of the support comb 102 in

[0060] As shown, the second leg 130 of the microelectrode film 104 winds around the support comb 102. The wire 106 passes along the second wiring surface 154 of the support comb 102. Each wire 106 passes through the channel formed by the finger 156. The wire 106 can pass through the hole 159 formed at the end of the channel 157 and enter the slot 152. The finger 156 (and the channel formed thereby) can enable routing the wire 106 along the support comb 102 and into the slot 152, where the wire 106 can be coupled to the contact 118.

[0061] Figure 17An enlarged view showing the coupling of the support comb 102 to the support tube 132 is shown. The first end of the support comb 102 may include a knob or other structure configured to fit within a portion of the support tube 132. The castellations 138 may surround the knob at the first end of the support comb 102. The probe shaft 140 may be formed by an epoxy overmolding process. The epoxy may flow into the area between the castellations 138 to form the probe shaft 140 that is coupled to the support tube 132. The epoxy of the probe shaft 140 may encapsulate the support comb 102 and the second leg 130 within the body of the distal end 110 of the stimulation lead. The probe shaft 140 may be formed by an injection molding or micromachining process.

[0062] Figure 18 and Figure 19 An exemplary configuration of the microelectrode membrane 104 and a method for forming the microelectrode membrane 104 into a cylinder are shown. Figure 19 A portion of the body 120 of the microelectrode membrane 104 in a partially wound state is shown. The first edge of the body 120 may include a plurality of protrusions 160. The opposite edge (or towards the opposite edge) may include a plurality of slots 162. The body 120 may include a slot 162 for each protrusion 160. The protrusions 160 may be tapered, narrowing as the protrusions 160 extend from the body 120. For example, the protrusions 160 may be shaped like arrowheads. Each protrusion 160 may slide into a corresponding one of the slots 162. The protrusions 160 may include barbs that lock the protrusions 160 into the slots 162 once the protrusions 160 are inserted into the slots 162 and past the barbs. Figure 19 The body 120 with the protrusions 160 fully inserted into the slots 162 to form a cylinder is shown.

[0063] Figure 20 An exemplary support tube 132 and marker 134 are shown. Figure 20 The exemplary support tube 132 shown may be made of a non-magnetic or non-radiopaque material. The marker 134 may be made of a radiopaque material. The support tube 132 may include a plurality of grooves 164. The grooves 164 may be shaped to receive the marker 134. The marker 134 may be fixed to the grooves 164 by an adhesive, a clip, or a press fit method. When the microelectrode membrane 104 is coupled to the support tube 132, the electrodes 108 may be aligned with the marker 134.

[0064] Figure 21An exemplary support comb 102 having a circular configuration is shown. The support comb 102 may include a plurality of slots 152 around the outer periphery of the support comb 102. The extension portion of the microelectrode membrane 104 may be disc-shaped and may include a plurality of contacts 118 distributed towards the outer periphery of the extension portion. The wire 106 may pass through each slot 152 and towards the contact 118. The slot 152 may align the wire 106 with the contact 118. The wire 106 may be wire-bonded or soldered to the contact 118.

[0065] Figure 22 An exemplary method 200 of manufacturing a wire device is shown. The method 200 may include providing a support comb (block 202). The method 200 may include positioning a plurality of wires (block 204). The method 200 may include coupling the support comb to the microelectrode membrane (block 206). The method 200 may include coupling the wires to the microelectrode membrane (block 208). The method 200 may include winding the microelectrode membrane (block 210).

[0066] As described above, the method 200 may include providing a support comb (block 202). Also refer to Figures 1 - 21 , the support comb 102 may include an attachment surface 142 and a first wiring surface 144. The first wiring surface 144 may include a plurality of slots 152. The microelectrode membrane 104 may include a second wiring surface 154. The second wiring surface 154 may include a plurality of fingers 156 that form channels on the second wiring surface 154. The channel 157 may terminate in a hole 159 that connects the channel 157 of the second wiring surface 154 to the slot 152 of the first wiring surface 144. The attachment surface 142 may include a channel 148.

[0067] The support comb 102 may be manufactured by an injection molding process, a micromachining process, a photolithography process, or a 3D printing process. The support comb 102 may be made of silicon, plastic, metal, liquid crystal polymer (LCP), or other materials. A radiopaque material may be included in the support comb 102 so that the distal end 110 can be seen during X-rays. For example, the polymer used in the injection molding process may be doped with a radiopaque material such as barium sulfate (BaSO4), boron, or a metal ring, strip, or component may be incorporated into the support comb 102.

[0068] The method 200 may include positioning the wires (block 204). See Figure 10, wherein the wire 106 can be deployed and extend along the second wiring surface 154. The second wiring surface 154 can dispose the wire 106. The second wiring surface 154 can include a plurality of fingers 156 that can define channels 157. The wire 106 can pass through the corresponding channels 157 and through holes 159 at the ends of the channels 157, which couple the channels 157 to the slots 152. Each wire 106 can pass through a corresponding one of the slots 152. The slots 152 can hold and position the wire 106. For example, the slots 152 can hold each wire 106 fixedly close to the corresponding contact 118.

[0069] Method 200 can include coupling the support comb 102 to the microelectrode membrane 104 (block 206). The microelectrode membrane 104 can include different parts. For example, the microelectrode membrane 104 can include a body 120 and an extension 122. The body 120 can include a plurality of electrodes 108. The extension 122 can include a plurality of legs. One leg can include a plurality of contacts 118. Both the extension portion 122 and the body 120 can include a plurality of traces 124.

[0070] The microelectrode membrane 104 can include a stack of an insulating layer and a conductive layer. The microelectrode membrane can be a thin film, a microelectromechanical systems (MEMS) electrode membrane. The conductive layer can include traces 124, contacts 118, and electrodes 108. Different conductive layers can be isolated from each other by the insulating layer. The insulating layer can also isolate the conductive layer (or portions thereof) from the external environment. The microelectrode membrane 104 can be manufactured as a planar membrane using an additive manufacturing process.

[0071] The microelectrode membrane 104 can be coupled to the support comb 102 by coupling a first portion of the microelectrode membrane 104 to the attachment surface 142. For example, a portion of the extension 122 can be coupled to the attachment surface 142. The first leg 128 of the extension portion 122 can include a plurality of contacts 118, which can be coupled to the attachment surface 142. The surface opposite the surface having the contacts 118 can be coupled to the attachment surface 142 such that the contacts 118 face away from the support comb 102.

[0072] When the microelectrode membrane 104 is coupled to the support comb 102, the opening 158 of the extension 122 can be aligned with the inlet 150 of the support comb 102. The microelectrode membrane 104 can be coupled to the support comb 102 by applying an adhesive to the inlet 150. Capillary forces can drive the adhesive from the inlet 150 and through the channel 148 to fill the space between the microelectrode membrane 104 and the support comb 102 formed by the channel 148. Once cured, the adhesive can couple the microelectrode membrane 104 to the support comb 102.

[0073] Method 200 can include coupling wires to the microelectrode membrane (block 208). Additionally, referring to Figure 15, wherein the wire 106 can pass through the corresponding channels on the second wiring surface 154 and enter the corresponding slots 152. The slots 152 can position each wire 106 near one of the contacts 118. The wire 106 can be coupled to the contact 118 by wire bonding, soldering, or laser bonding.

[0074] The method 200 can include winding the microelectrode membrane (block 210). The extension 122 of the microelectrode membrane 104 can be wound around the support comb 102. The body 120 of the microelectrode membrane 104 can be wound around the support comb 102. Winding the extension 122 around the support comb 102 can place the second leg 130 of the extension 122 near the second wiring surface 154 of the support comb 102.

[0075] The body 120 of the microelectrode membrane 104 can be wound around the support tube 132. The microelectrode membrane 104 can be coupled to the outer surface of the support tube 132. The support tube 132 can include slots 136. The opposite edges of the body 120 can be inserted into the slots 136.

[0076] Once the microelectrode membrane 104 is wound, the microelectrode membrane 104 and the support comb 102 can be placed in a mold. The mold can be filled with epoxy resin. The epoxy resin overmolding can form the probe shaft 140. The probe shaft 140 can enclose at least a portion of the extension 122, the support comb 102, and the wire 106. The probe shaft 140 can flow into the castellations 138 and be coupled to the support tube 132.

[0077] Although the operations are depicted in the drawings in a particular order, such operations need not be performed in the particular order shown or in sequential order, and all of the illustrated operations need not be performed. The actions described herein can be performed in a different order.

[0078] The separation of the various system components need not be separated in all implementations, and the described program components can be included in a single hardware or software product.

[0079] Some illustrative implementations have now been described. It is apparent that the foregoing is illustrative and not restrictive, and has been presented by way of example. In particular, although many of the examples presented herein involve specific combinations of method acts or system elements, those acts and those elements can be combined in other ways to achieve the same purpose. The acts, elements, and features discussed in connection with one implementation are not intended to be excluded from other implementations or from similar roles in other implementations.

[0080] The terminology and phraseology used herein are for the purpose of description and should not be regarded as limiting. As used herein, the terms "comprising," "including," "having," "containing," "involving," "characterized by," and variations thereof mean including the items listed thereafter, their equivalents, and additional items, as well as alternative embodiments consisting exclusively of the items listed thereafter. In one embodiment, the systems and methods described herein consist of each combination of one, more than one, or all of the described elements, acts, or components, or all of the described elements, acts, or components.

[0081] As used herein, the terms "about" and "substantially" will be understood by those of ordinary skill in the art and will vary to some extent depending on the context in which they are used. If the context in which the term is used is not clear to those of ordinary skill in the art, "about" will mean up to plus or minus 10% of the particular term.

[0082] Any reference to an implementation, element, or act of the systems and methods herein in the singular form may also cover implementations including a plurality of such elements, and any plural reference to any implementation, element, or act herein may also cover implementations including only a single element. References in the singular or plural form are not intended to limit the systems or methods of the present disclosure, their components, acts, or elements to a single or plural configuration. Any reference to an act or element based on any information, act, or element may include implementations in which the act or element is at least partially based on any information, act, or element.

[0083] Any embodiment disclosed herein may be combined with any other embodiment or example, and references to "embodiment," "some embodiments," "one embodiment," etc. are not necessarily mutually exclusive and are intended to indicate that the particular features, structures, or characteristics described in connection with the embodiment may be included in at least one embodiment or example. These terms as used herein do not necessarily all refer to the same implementation. Any embodiment may be combined inclusively or exclusively with any other embodiment in any manner consistent with the aspects and embodiments disclosed herein.

[0084] Unless expressly stated to the contrary, the indefinite articles "a" and "an" as used in this specification and the claims should be understood to mean "at least one."

[0085] References to "or" may be construed as inclusive, such that any term described using "or" may indicate a single one, more than one, and any one of all of the described terms. For example, a reference to "at least one of 'A' and 'B'" may include only "A," only "B," and include "A" and "B." These references used in conjunction with "including" or other open terms may include additional items.

[0086] Where technical features in the drawings, the detailed description, or any claims are followed by reference signs, the reference signs are included to enhance the intelligibility of the drawings, the detailed description, and the claims. Accordingly, the reference signs, or their absence, have no limiting effect on the scope of any claim element.

[0087] Without departing from the features of the present invention, the systems and methods described herein may be implemented in other specific forms. The foregoing implementations are illustrative rather than limiting of the systems and methods described. Accordingly, the scope of the systems and methods described herein is indicated by the appended claims rather than the foregoing description, and variations within the meaning and range of equivalents of the claims are included therein.

Claims

1. An implantable lead device, comprising: A support comb, comprising: An attachment surface; and A wiring surface including a plurality of slots; A microelectrode membrane, comprising: A body having a plurality of electrodes; A first leg extending from the body of the microelectrode membrane, the first leg comprising: A first surface having a plurality of electrical contacts coupled to the plurality of electrodes; A second surface coupled to the attachment surface of the support comb; and An opening defined through the first leg and aligned with an inlet of the attachment surface of the support comb; and A second leg extending from the body of the microelectrode membrane, at least a portion of the second leg being separated from a portion of the first leg, the second leg comprising a plurality of traces that couple a subset of the plurality of electrodes of the microelectrode membrane to the plurality of electrical contacts on the first surface of the first leg; and The first leg and the second leg are wound around the support comb; A plurality of wires, each of the plurality of wires passing through a respective one of the plurality of slots and coupled to a respective one of the plurality of electrical contacts; and A support tube, the support tube including a plurality of radiopaque markers aligned with the plurality of electrodes, the support tube being coupled to a surface of the body of the microelectrode membrane.

2. The lead device according to claim 1, wherein the attachment surface includes a channel to direct an adhesive beneath at least a portion of the second surface of the microelectrode membrane.

3. The lead device according to claim 1, wherein the support tube includes a plurality of castellations on a first end configured to mate with the support comb.

4. The lead device according to claim 1, wherein each of the plurality of wires is coupled to a respective one of the plurality of electrical contacts using wire bonding.

5. The lead device according to claim 1, including an epoxy resin that backfills the microelectrode membrane.

6. A method, comprising: Providing a support comb, the support comb comprising: An attachment surface; and A wiring surface including a plurality of slots; Coupling a first leg extending from the body of a microelectrode membrane to the attachment surface of the support comb, the first leg of the microelectrode membrane comprising: A first surface having a plurality of electrical contacts coupled to the plurality of electrodes of the microelectrode membrane; A second surface coupled to the attachment surface of the support comb; and An opening defined through the first leg and aligned with an inlet of the attachment surface of the support comb; Positioning each of the plurality of wires to pass through a respective one of the plurality of slots in the wiring surface; Coupling each of the plurality of wires to a respective one of the plurality of electrical contacts; Forming a second leg extending from the body of the microelectrode membrane, the second leg comprising a plurality of traces that couple a subset of the plurality of electrodes of the microelectrode membrane to the plurality of electrical contacts on the first surface of the first leg, at least a portion of the second leg being separated from a portion of the first leg; Couple the second leg of the microelectrode membrane to the outer surface of a support tube, the support tube including a plurality of radiopaque markers; Align the plurality of radiopaque markers with the plurality of electrodes formed in the microelectrode membrane; and Wind the first leg and the second leg of the microelectrode membrane around the support comb.

7. The method according to claim 6, comprising: Form a third portion of the microelectrode membrane, the third portion including a plurality of traces coupling a portion of the plurality of electrodes to a portion of the plurality of electrical contacts.

8. The method according to claim 6, comprising: Fill the support tube with epoxy resin.

9. The method according to claim 6, comprising: Form the plurality of radiopaque markers in the support tube.

10. The method according to claim 6, comprising: Wire bond each of the plurality of wires to a corresponding one of the plurality of electrical contacts.

11. The method according to claim 6, comprising: Wind the second leg of the microelectrode membrane to form a cylinder; and Fill the cylinder with epoxy resin.

12. The method according to claim 6, comprising: Bottom fill the channels formed in the attachment surface with epoxy resin to couple the first leg of the microelectrode membrane to the attachment surface.

13. The method according to claim 6, comprising: Etch a support comb in silicon.

14. The method according to claim 6, comprising: Couple the first edge of the microelectrode membrane to the second edge of the microelectrode membrane to form a cylinder.

15. The method according to claim 6, comprising: Couple the microelectrode membrane to the support tube; and Insert the first and second edges of the microelectrode membrane into slots in the support tube.

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