Abstract: An electrical stimulation lead includes a paddle body, at least one lead body having a distal end, a proximal end, and a longitudinal length with the distal end of the lead body coupled to the paddle body. The lead further includes fixation elements and electrodes. The fixation elements are disposed entirely within the paddle body and the electrodes are disposed on the paddle body. Each of the electrodes includes a stimulating element with an exposed stimulation surface, and a piercing element extending from the stimulating element into the paddle body and making contact with at least one of the fixation elements. Further, the lead includes terminals disposed along the proximal end of the lead body and conductor wires electrically coupling the electrodes to the terminals. In addition, methods of making stimulation leads using sacrificial portions of electrodes are presented.

Abstract: An electrical stimulation lead includes a lead body; electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body; terminals disposed along the proximal portion of the lead body; and conductors coupling the terminals to the electrodes. The lead also includes a conductor guide disposed within the lead body and extending from the proximal portion of the lead body. The conductor guide defines a central lumen and a plurality of conductor lumens disposed around the central lumen. The lead further includes a stiffening agent disposed within at least one of the conductor lumens. The stiffening agent includes a) a material formed from a granular particulate material, b) a polymeric material having a durometer at least 10% greater than the durometer of the conductor guide, or c) a continuous epoxy layer within which discrete epoxy particles are also disposed.

Abstract: An electrical stimulation lead includes at least one lead body and at least one thin, elongate anchoring element. The lead body defines at least one anchoring lumen extending longitudinally along at least a portion of the lead body and at least one open slot in the lead body where each anchoring lumen is open at one of the at least one open slot. For each anchoring element, the first end of the anchoring element is disposed in one of the at least one anchoring lumen and the second end of the anchoring element is configured and arranged preferentially to extend out of the open slot associated with the anchoring lumen and away from the lead body in a deployed configuration unless the second end is constrained in a constrained configuration adjacent or within the lead body.

Abstract: An anchoring unit is disposed on a lead body of an electrical stimulation lead. The anchoring unit has a first end and a second end and includes a first attachment ring disposed at the first end, a second attachment ring disposed at the second end, and longitudinal struts extending linearly between, and coupled to, the first and second attachment rings. At least a portion of each longitudinal strut rests against the lead body in a retracted position, and each anchoring unit has a deployed position in which the first and second attachment rings are positioned closer together with the longitudinal struts extending away from the lead body to contact patient tissue and anchor the lead within the patient tissue.

Abstract: A lead anchor includes an anchor body defining an open lead channel; and a rotatable locking element shaped as a portion of a ring and defining a central cavity, an entrance slit, and a protruding nodule extending into the central cavity. The anchor body further defines a locking element channel arranged perpendicular to the lead channel to receive the rotatable locking element. In an open position, the entrance slit of the locking element is aligned with the lead channel of the anchor body so that a lead can be loaded into the lead channel and, in a closed position, the entrance slit is not aligned with the lead channel to prevent a lead disposed in the lead channel from disengaging from the lead anchor. In the closed position, the nodule on the locking element engages the lead and resists rotation of the locking element to the open position.

Abstract: An electrical stimulation lead includes at least one anchoring unit and each anchoring unit includes a lead attachment element. Some anchoring units include one or more anchoring fins attached to the lead attachment element and extending away from the lead attachment element when in a deployed position for contact with patient tissue to anchor the lead within the patient tissue. Each anchoring fin also has a retracted position in which the anchoring fin folds down and lies next to the lead attachment element. Other anchoring units include one or more anchoring tabs defined by the lead attachment element. Each anchoring tab is partially separated from a remainder of the lead attachment element by at least one cutout and extends away from the remainder of the lead attachment element when in a deployed position for contact with patient tissue to anchor the lead within the patient tissue.

Abstract: An implantable lead anchor includes a first anchor shell having a first hinge element and a second anchor shell, disposed opposite the first anchor shell, having a second hinge element. The first and second anchor shells define a lead channel and the first and second hinge elements form a hinge. The lead anchor includes at least one tensioning element that is configured and arranged to increase in tension upon elongation. The first and second anchor shells, and the tensioning element provide an open position and a closed position. In the open position, a lead can be side loaded side loaded into the lead channel. In the closed position, the first and second anchor shells grip a portion of the lead disposed in the lead channel and, in combination with the at least one tensioning element, resist disengagement of the lead from the lead anchor.

Abstract: A method of making a stimulation lead includes disposing a pre-electrode along a distal end portion of a lead body. The pre-electrode includes a body having a central hub and stimulation members individually coupled to the central hub and extending radially-outward therefrom such that each of the stimulation members is electrically-coupled to each of the remaining stimulation members solely via the central hub. Conductors extending from terminals disposed along a proximal end portion of the lead body are electrically-coupled to each of the stimulation members. Electrically-nonconductive material is disposed around longitudinal surfaces of the central hub with the electrically-nonconductive material abutting inner surfaces of the stimulation members.

Abstract: An electrical stimulation lead includes at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length; multiple electrodes disposed along the distal end portion of the at least one lead body; and at least one terminal disposed along the proximal end portion of the at least one lead body. The lead has more electrodes than terminals. The lead also includes a signal separator disposed along the lead between the electrodes and the at least one terminal; at least one terminal conductor electrically coupling the at least one terminal to the signal separator; and multiple electrode conductors. Each electrode conductor electrically couples the signal separator to a different one of the electrodes. The lead has more electrode conductors than terminal conductors. The signal separator receives signals from the at least one terminal conductor and separates the signals by frequency into electrode signals.

Abstract: A lead anchor includes an anchor body defining an open lead channel; and a rotatable locking element shaped as a portion of a ring and defining a central cavity, an entrance slit, and a protruding nodule extending into the central cavity. The anchor body further defines a locking element channel arranged perpendicular to the lead channel to receive the rotatable locking element. In an open position, the entrance slit of the locking element is aligned with the lead channel of the anchor body so that a lead can be loaded into the lead channel and, in a closed position, the entrance slit is not aligned with the lead channel to prevent a lead disposed in the lead channel from disengaging from the lead anchor. In the closed position, the nodule on the locking element engages the lead and resists rotation of the locking element to the open position.

Abstract: An implantable lead anchor includes a first anchor shell and a second anchor shell. The first and second anchor shells define two parallel lead channels. The lead anchor also includes an actuating mechanism to operably adjust the first and second anchor shells between a load position and a lock position. In the lock position, the first and second anchor shells are closer together than in the load position and any lead disposed within one of She two parallel lead channels is locked in place. In the load position, the first and second anchor shells are sufficiently spaced apart so that a portion of a lead can be side-loaded between the first and second anchor shells. The lead anchor also includes at least one guide element that extends between the first and second anchor shells to maintain an orientation of the first and second anchor shells relative to each other.

Abstract: A lead anchor includes a core housing defining a cavity; a swivel anchor disposed in the cavity and having a tubular portion and a locking portion; at least two locking members; and at least two sleeves with a portion of each of the sleeves and each of the locking members disposed within the cavity at a periphery of the cavity. The tubular portion is adapted to receive an external tool to rotate the swivel anchor within the cavity. The lead anchor has an unlocked configuration, in which the swivel anchor can rotate within the cavity of the core housing without compressing the sleeves, and a locked configuration, in which opposing ends of the locking portion of the swivel anchor each lie between one of the sleeves and one of the locking members and compress the sleeves and any lead disposed within the sleeves to hold that lead in place.

Abstract: An electrical stimulation lead includes a lead body; electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body; terminals disposed along the proximal portion of the lead body; and conductors coupling the terminals to the electrodes. The lead also includes a conductor guide disposed within the lead body and extending from the proximal portion of the lead body. The conductor guide defines a central lumen and a plurality of conductor lumens disposed around the central lumen. The lead further includes a stiffening agent disposed within at least one of the conductor lumens. The stiffening agent includes a) a material formed from a granular particulate material, b) a polymeric material having a durometer at least 10% greater than the durometer of the conductor guide, or c) a continuous epoxy layer within which discrete epoxy particles are also disposed.

Abstract: An electrical stimulation lead includes a paddle body, at least one lead body having a distal end, a proximal end, and a longitudinal length with the distal end of the lead body coupled to the paddle body. The lead further includes fixation elements and electrodes. The fixation elements are disposed entirely within the paddle body and the electrodes are disposed on the paddle body. Each of the electrodes includes a stimulating element with an exposed stimulation surface, and a piercing element extending from the stimulating element into the paddle body and making contact with at least one of the fixation elements. Further, the lead includes terminals disposed along the proximal end of the lead body and conductor wires electrically coupling the electrodes to the terminals. In addition, methods of making stimulation leads using sacrificial portions of electrodes are presented.

Abstract: An electrical stimulation lead includes a lead body that defines a central lumen extending along the longitudinal length of the lead body. The stimulation lead includes electrodes disposed along the distal end of the lead body, terminals disposed along the proximal end of the lead body, and conductors. Each conductor electrically couples at least one of the electrodes to at least one of the terminals. The stimulation lead also includes a tubular reinforcing member disposed in the central lumen of the lead body within a portion of the distal end of the lead body or at least one reinforcing member disposed upon the distal end of the lead body proximal of the plurality of electrodes. The reinforcing member stiffens a portion of the distal end of the lead body.

Abstract: An electrical stimulation lead includes electrodes disposed along a distal end portion of a lead body; terminals disposed along a proximal end portion of the lead body; and stimulation conductors electrically coupling the terminals to the electrodes. A light-emitter is disposed along the distal end portion of the lead body. A light source is disposed along the at least one lead body and converts received electrical power into light. An optical transport medium is disposed along the at least one lead body. The optical transport medium extends between the light source and the light-emitter. A light source conductor electrically couples the light source and the terminals. A drug-dispensing port is defined along the distal end portion of the lead body. A drug-delivery channel is in fluid communication with the at least one drug-dispensing port and extends to the proximal end portion of the lead body.

Abstract: A lead arrangement includes a plurality of proximal leads, a distal lead, and a junction electrically and mechanically coupling the plurality of proximal leads to the at least one distal lead. Each proximal lead has a proximal end and a distal end and includes conductive contacts disposed along the proximal end and conductive wires coupled to the conductive contacts and extending to the distal end of the proximal lead. Each distal lead has a proximal end and a distal end and includes electrodes disposed along the distal end and conductive wires coupled to the electrodes and extending to the proximal end of the distal lead. The junction includes conductive tabs and a non-conductive material encapsulating the conductive tabs. The conductive wires of the at least one distal lead and the conductive wires of the plurality of proximal leads are attached to the conductive tabs of the junction.

Abstract: A multi-lead introducer for facilitating implantation of stimulation leads includes a needle assembly for concurrently implanting multiple leads into a patient. The needle assembly includes a first needle with a first needle lumen configured to receive a first lead. A first sharpened tip is disposed along a first end of the first needle for piercing patient tissue. A second needle defines a second needle lumen configured to receive a second lead. A second sharpened tip is disposed along a first end of the second needle for piercing patient tissue. A hub is coupled to second ends of both the first needle and the second needle. The hub defines a hub lumen that is in communication with both the first needle lumen and the second needle lumen. The hub lumen is configured to concurrently receive both the first lead and the second lead.

Abstract: A lead anchor includes a core housing defining a cavity; a swivel anchor disposed in the cavity and having a tubular portion and a locking portion; at least two locking members; and at least two sleeves with a portion of each of the sleeves and each of the locking members disposed within the cavity at a periphery of the cavity. The tubular portion is adapted to receive an external tool to rotate the swivel anchor within the cavity. The lead anchor has an unlocked configuration, in which the swivel anchor can rotate within the cavity of the core housing without compressing the sleeves, and a locked configuration, in which opposing ends of the locking portion of the swivel anchor each lie between one of the sleeves and one of the locking members and compress the sleeves and any lead disposed within the sleeves to hold that lead in place.

Abstract: An implantable electrical stimulation lead including a lead body having a distal end, a proximal end, and a longitudinal length, wherein the distal end of the lead body is formed into a hook or coil shape; a plurality of electrodes disposed along the hook or coil at the distal end of the lead body; a plurality of terminals disposed on the proximal end of the lead body; and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals. The lead can be used to stimulate, for example, a dorsal root ganglion with the hook-shaped or coil-shaped distal end disposed around a portion of the dorsal root ganglion.