Abstract: A lead assembly and a method of making a lead are provided. The method of making a multi-contact lead assembly comprises placing monofilament placed in the void spaces not occupied by the plurality of conductor wires and, in one embodiment, thermally fusing the monofilament to the like material spacer by applying heat just below the melting temperature of the monofilament and spacer material. Alternatively, the monofilament and spacer may be of different materials and heat is applied to cause at least one material to thermally reflow or melt. The conductive contacts may be located at either the distal end and/or proximal end of the lead. Oversized spacers may be used in order to provide extra material to fill voids during the thermal fusion/reflow process.

Abstract: A method of making a lead for a stimulation device includes forming at least one pre-electrode in the shape of a ring, the at least one pre-electrode comprises at least two thin-walled portions separated by at least two thick-walled portions; disposing the at least one pre-electrode near a distal end of a lead body; joining at least one conductor to each thick-walled portion of the at least one pre-electrode; and grinding the lead body and the at least one pre-electrode to remove the thin-walled portions of the at least one pre-electrode to form segmented electrodes from the thick-walled portions of the at least one pre-electrode.

Abstract: An electrical stimulation lead includes a lead body; a terminal disposed along the proximal end portion of the lead body; a single electrode disposed at the distal end of the lead body; a conductor extending along the lead body and electrically coupling the terminal to the single electrode; and an adjustable sheath disposed over a portion of the lead body to cover a selected portion of the single electrode by displacing the sheath forwards or backwards relative to the single electrode to control a size of a portion of the electrode exposed for stimulation of tissue. Another electrical stimulation lead has a low-profile distal portion that has a smaller lateral width in at least one direction than a remainder of the lead body. Yet another arrangement includes a guidewire with a mapping electrode to map a region around a peripheral nerve prior to implantation of an electrical stimulation lead.

Abstract: An insertion tool for a paddle lead includes an insertion tool body having a receiving end portion; a stylet channel extending along the insertion tool body; a stylet disposed in the stylet channel; and an actuator assembly disposed along the handling end portion of the insertion tool body and coupled to the stylet. The actuator assembly controls transitioning of the stylet between a first position and a second position. In some instances, the stylet can be a wire stylet that is inserted into a lumen in the paddle body of the paddle lead. In some instances, the stylet of the insertion tool pushes lead bodies of the paddle lead out of the insertion tool to release the paddle lead. In some instances, the insertion tool includes a paddle envelope to hold the paddle lead.

Abstract: An electrical stimulation lead includes: a lead body having a proximal portion, a distal portion, and a longitudinal length; electrodes disposed along the distal portion of the lead body; terminals disposed along the proximal portion of the lead body; and conductors electrically coupling the terminals to the electrodes. A sensor assembly is disposed in the lead body in proximity to the electrodes. The sensor assembly is configured and arranged for sensing a magnetic field in three different directions to facilitate determination of a position and orientation of the electrodes based on the sensing. The sensor assembly has a largest transverse dimension of no greater than 0.5 millimeters.

Abstract: A trial electrical stimulation lead includes a lead body having a distal end portion, a proximal end portion, and a longitudinal length; electrodes disposed along the distal end portion of the lead body; terminals disposed along the proximal end portion of the lead body; conductors electrically coupling the terminals to the electrodes; and a preventer extending proximally from the proximal end portion of the lead body. The preventer has a diameter smaller than a diameter of the lead body. The preventer prevents coupling of the trial electrical stimulation lead to an implantable control module, but permits coupling to an external trial stimulation system.

Abstract: An electrical-stimulation lead includes a body having a distal portion, a proximal portion, and a perimeter; electrodes disposed along the distal portion of the body and including segmented electrodes that each extend around no more than 50% of the perimeter of the body; terminals disposed along the proximal portion of the body; and conductors electrically-coupling the terminals to the electrodes; and at least one anchoring unit disposed along the distal portion of the body and configured and arranged for resisting rotation of the body and electrodes relative to patient tissue upon implantation of the lead. Each anchoring unit includes a lead-attachment element and at least one anchoring element attached to the lead-attachment element. The anchoring element extends away from the lead-attachment element and is configured and arranged for physically contacting patient tissue and resisting rotation of the body in proximity to the anchoring element.

Abstract: A stimulation lead includes an electrode carrier disposed along a distal portion of a lead body. The electrode carrier defines multiple segmented-electrode-receiving apertures extending between an outer surface and a central lumen. Each of the segmented-electrode-receiving apertures includes a ledge disposed around a perimeter of that segmented-electrode-receiving aperture and inset from the outer surface of the electrode carrier. The stimulation lead also includes multiple segmented electrodes, with each of the segmented electrode disposed in a different one of the segmented-electrode-receiving apertures with an outer stimulation surface exposed through the segmented-electrode-receiving aperture and an inner surface abutting the ledge disposed around the perimeter of that segmented-electrode-receiving aperture. Conductive wires extend along the lead body and couple the segmented electrodes to terminals.

Abstract: An insertion tool for a paddle lead includes an insertion tool body having a receiving end portion; a stylet channel extending along the insertion tool body; a stylet disposed in the stylet channel; and an actuator assembly disposed along the handling end portion of the insertion tool body and coupled to the stylet. The actuator assembly controls transitioning of the stylet between a first position and a second position. In some instances, the stylet can be a wire stylet that is inserted into a lumen in the paddle body of the paddle lead. In some instances, the stylet of the insertion tool pushes lead bodies of the paddle lead out of the insertion tool to release the paddle lead. In some instances, the insertion tool includes a paddle envelope to hold the paddle lead.

Abstract: A method of making a stimulation lead includes attaching multiple segmented electrodes to a carrier. Each of the segmented electrodes has a curved form extending over an arc in the range of 10 to 345 degrees. The method further includes attaching conductors to the segmented electrodes; forming the carrier into a cylinder with segmented electrodes disposed within the cylinder; molding a lead body around the segmented electrodes disposed on the carrier; and removing at least a portion of the carrier to separate the segmented electrodes.

Abstract: An electrical stimulation lead includes a lead body; a terminal disposed along the proximal end portion of the lead body; a single electrode disposed at the distal end of the lead body; a conductor extending along the lead body and electrically coupling the terminal to the single electrode; and an adjustable sheath disposed over a portion of the lead body to cover a selected portion of the single electrode by displacing the sheath forwards or backwards relative to the single electrode to control a size of a portion of the electrode exposed for stimulation of tissue. Another electrical stimulation lead has a low-profile distal portion that has a smaller lateral width in at least one direction than a remainder of the lead body. Yet another arrangement includes a guidewire with a mapping electrode to map a region around a peripheral nerve prior to implantation of an electrical stimulation lead.

Abstract: An electrical stimulation lead includes a cog-shaped conductor guide disposed either at the proximal end or the distal end of the lead. The cog-shaped conductor guide includes a central core and multiple protrusions extending outwards from the core. Conductor tracks are defined within the cog-shaped conductor guide between adjacent protrusions. Electrodes are provided along the distal end of the lead, terminals are provided along the proximal end of the lead, and conductors couple the electrodes to the terminals. An elongated lead body extends from the electrodes to the terminals of the lead. Each of the conductors has an end portion positioned within one of the conductor tracks of the cog-shaped conductor guide.

Abstract: A method for implanting a lead for stimulation of a dorsal root ganglion of a patient includes advancing a distal portion of a guidewire using an introducer into an epidural space of the patient and through a foramen of the patient to a position near the dorsal root ganglion, the guidewire including an electrode in the distal portion of the guidewire; mapping a region around the dorsal root ganglion using the electrode of the guidewire to identify a lead implantation site; removing the introducer; and advancing the lead over the guidewire, with a portion of the guidewire disposed in a lumen of the lead, to position a distal portion of the lead at the lead implantation site.

Abstract: An insertion tool for a paddle lead includes an insertion tool body having a receiving end portion; a stylet channel extending along the insertion tool body; a stylet disposed in the stylet channel; and an actuator assembly disposed along the handling end portion of the insertion tool body and coupled to the stylet. The actuator assembly controls transitioning of the stylet between a first position and a second position. In some instances, the stylet can be a wire stylet that is inserted into a lumen in the paddle body of the paddle lead. In some instances, the stylet of the insertion tool pushes lead bodies of the paddle lead out of the insertion tool to release the paddle lead. In some instances, the insertion tool includes a paddle envelope to hold the paddle lead.

Abstract: A method of manufacturing a device for brain stimulation includes forming a lead body having a distal end section and coupling at least one pre-electrode to the distal end section of the lead body. The pre-electrode defines a divider with a plurality of partitioning arms, and has a plurality of fixing lumens. A portion of the pre-electrode aligned with the portioning arms is removed to divide the pre-electrode into a plurality of segmented electrodes. Each of the plurality of segmented electrodes defines at least one of the plurality of fixing lumens at least partially disposed through the segmented electrode. A material is introduced through the at least one fixing lumen to couple the plurality of segmented electrodes to the lead body.

Abstract: A stimulation lead extends from a proximal end to a distal end and includes a plurality of electrodes disposed along the distal end of the lead; a plurality of terminals disposed along the proximal end of the lead; and an elongated body separating the plurality of electrodes from the plurality of terminals. The elongated body includes an outer tube of insulative material, and a cog-shaped conductor guide disposed within the outer tube. The conductor guide includes a central core and a plurality of protrusions extending outward from the central core. The plurality of protrusions and the outer tube define a plurality of pocket regions. The stimulation further includes a plurality of conductors disposed within the plurality of pocket regions, each conductor coupling at least one of the plurality of electrodes to at least one of the plurality of terminals.

Abstract: An electrical stimulation lead includes a lead body insertable into a patient. Electrodes are disposed along the lead body. The electrodes include at least two sets of segmented electrodes. Each set of segmented electrodes includes a first segmented electrode and a second segmented electrode radially spaced apart from one another around a circumference of the lead body. A tab is disposed on the first segmented electrode of each set of segmented electrodes. The tabs extend into the lead body. A guide feature is disposed on the tabs. The guide features are each radially aligned with one another along the length of the lead body. Conductors extend along the length of the lead body from a proximal end to the electrodes. Each of the conductors is electrically coupled to at least one of the electrodes. At least one of the conductors extends through the radially-aligned guide features of the tabs.

Abstract: A lead assembly and a method of making a lead are provided. The method of making a multi-contact lead assembly comprises placing monofilament placed in the void spaces not occupied by the plurality of conductor wires and, in one embodiment, thermally fusing the monofilament to the like material spacer by applying heat just below the melting temperature of the monofilament and spacer material. Alternatively, the monofilament and spacer may be of different materials and heat is applied to cause at least one material to thermally reflow or melt. The conductive contacts may be located at either the distal end and/or proximal end of the lead. Oversized spacers may be used in order to provide extra material to fill voids during the thermal fusion/reflow process.

Abstract: A percutaneously implantable paddle lead includes an elongated lead body having a proximal portion and a distal portion; a plurality of terminals disposed on the proximal portion of the lead; a flexible paddle body coupled to the distal portion of the lead; and a plurality of electrodes disposed in the paddle body and electrically coupled to the terminals on the proximal portion of the lead. The percutaneously implantable paddle lead also includes a bonding material in contact with the paddle body and holding the paddle body in a compacted form prior to, and during, insertion into a percutaneous implantation tool. The bonding material is configured and arranged to release the paddle body during or soon after implantation into a patient so that the paddle body can deploy into its paddle-like form. Alternatively, at least one current-degradable fastener can be used instead of the binding material.

Abstract: A method for manufacturing a lead includes pre-forming at least one relief section along a length of an elongated conductor having a first end and an opposing second end. The conductor with the pre-formed relief section is inserted into a conductor lumen defined along a length of an elongated lead body. The lead body has a first end and an opposing second end. An electrode is disposed at the first end of the lead body. The first end of the conductor is electrically coupled to the electrode. A terminal is disposed at the second end of the lead body. The second end of the conductor is electrically coupled to the terminal.