Abstract: An adapter to add optical stimulation to a stimulation system includes an adapter body and a connector disposed on the distal end of the adapter body. The connector includes a connector body defining a port and a connector lumen; connector contacts disposed in the connector body and arranged along the connector lumen; and a light source disposed in the connector body. The adapter also includes terminals disposed along the proximal end of the adapter body and conductors extending along the adapter body and electrically coupling the connector contacts and the light source to the terminals. The adapter may be used with an optical stylet that fits into a stimulation lead which is, in turn, coupled to the connector of the adapter. Alternatively, the adapter can include a fiber optic coupled to the light source and configured to extend into the stimulation lead.

Abstract: A lead introducer includes an integrated sheath/needle including a splittable sheath configured to split a into a first portion and a second portion, a needle having a length and a proximal end region, and a hub coupled to the proximal end regions of the splittable sheath and the needle and configured to split into a first portion and a second portion. The needle is permanently attached to either the first portion of the hub or the first portion of the splittable sheath (or both) so that when the hub is split into the first and second portions, the needle remains attached to the first portion of the hub or the first portion of the splittable sheath.

Abstract: An adapter to add optical stimulation to a stimulation system includes an adapter body and a connector disposed on the distal end of the adapter body. The connector includes a connector body defining a port and a connector lumen; connector contacts disposed in the connector body and arranged along the connector lumen; and a light source disposed in the connector body. The adapter also includes terminals disposed along the proximal end of the adapter body and conductors extending along the adapter body and electrically coupling the connector contacts and the light source to the terminals. The adapter may be used with an optical stylet that fits into a stimulation lead which is, in turn, coupled to the connector of the adapter. Alternatively, the adapter can include a fiber optic coupled to the light source and configured to extend into the stimulation lead.

Abstract: A medical device kit includes a tunneling tool configured to form a tunnel through patient tissue for receiving an electrical stimulation lead. The tunneling tool includes a tunneling-tool body having an elongated shape with a proximal portion and a distal portion. The tunneling-tool body is formed from a material configured to be manually bent prior to insertion into patient tissue to conform to an anatomical contour through which the tunnel is to extend. A blunt tip is disposed at the distal portion. The blunt tip is configured to tunnel through patient tissue. A tunneling-tool suture-receiving element is disposed along the proximal portion of the tunneling-tool body. The tunneling-tool suture-receiving element is configured to receive a suture extendable along the tunnel formed by the tunneling tool.

Abstract: A method for implanting a lead includes inserting a needle into the patient; inserting a lead blank through the needle; steering the lead blank to, or near, a lead implantation site; removing the needle from the patient and leaving the lead blank; advancing a flexible sheath over the lead blank after removing the needle; removing the lead blank from the patient and leaving the flexible sheath; inserting a lead through the flexible sheath, after removing the lead blank, and implanting the lead at the lead implantation site; and removing the flexible sheath. The flexible sheath can also be used for explanting a lead and, optionally, implanting a new lead.

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.

Abstract: A lead anchor includes a lead passageway defined along a central body and configured to receive a lead. The central body includes a twistable region that reversibly twists and stretches. First and second hubs are coupled to opposing ends of the central body. The first hub is rotatable relative to the second hub about the central body. Rotation of the first hub relative to the second hub causes twisting of the twistable region. When a lead is inserted into the lead passageway and the twistable region is twisted into a twisted configuration the central body compresses against the lead to retain the lead within the lead passageway. A locking mechanism transitions the hubs between an unlocked position, where the first hub is rotatable relative to the second hub, and a locked position, where the hubs resist rotation relative to one another.

Abstract: A lead introducer includes an integrated sheath/needle including a splittable sheath configured to split a into a first portion and a second portion, a needle having a length and a proximal end region, and a hub coupled to the proximal end regions of the splittable sheath and the needle and configured to split into a first portion and a second portion. The needle is permanently attached to either the first portion of the hub or the first portion of the splittable sheath (or both) so that when the hub is split into the first and second portions, the needle remains attached to the first portion of the hub or the first portion of the splittable sheath.

Abstract: An implantable electrical stimulation lead includes a lead body having a proximal portion and a distal portion; electrodes disposed along the distal portion of the lead body; terminals disposed along the proximal portion of the lead body; conductor extending along the lead body and electrically coupling the electrodes to the terminals; and a flexible hinge forming part of the distal portion of the lead body and disposed proximal to the electrodes, wherein the flexible hinge is structurally distinguishable from adjacent regions of the lead body and more flexible than the adjacent regions.

Abstract: An electrical stimulation lead includes a body having distal and proximal end portions, a longitudinal length, at least one anchoring lumen, and at least one open slot spaced apart from each end of the lead body. Each anchoring lumen is open at a slot and extends both distally and proximally from the slot. The lead also includes electrodes; terminals; conductors electrically coupling the terminals to the electrodes; and at least one anchoring element at least partially disposed in an anchoring lumen. Each anchoring element includes at least one bent portion biased to extend an extension portion of the anchoring element out of a slot when the anchoring element is in a deployed position and can retract the extension portion into an anchoring lumen when the anchoring element is in a constrained position. The lead further includes an attachment member attached to each anchoring element and disposed proximal to each slot.

Abstract: An adapter to add optical stimulation to a stimulation system includes an adapter body and a connector disposed on the distal end of the adapter body. The connector includes a connector body defining a port and a connector lumen; connector contacts disposed in the connector body and arranged along the connector lumen; and a light source disposed in the connector body. The adapter also includes terminals disposed along the proximal end of the adapter body and conductors extending along the adapter body and electrically coupling the connector contacts and the light source to the terminals. The adapter may be used with an optical stylet that fits into a stimulation lead which is, in turn, coupled to the connector of the adapter. Alternatively, the adapter can include a fiber optic coupled to the light source and configured to extend into the stimulation lead.

Abstract: An implantable electrical stimulation lead can be used for spinal cord stimulation. Leads with segmented electrodes can be used to provide both medial and lateral stimulation. Multiple leads with segmented electrodes can provide paddle-like stimulation. Leads with bent distal portions can facilitate stimulation of multiple elements of the spinal cord and associated anatomy such as, for example, the dorsal column, dorsal, horn, dorsal root ganglia, and the like.

Abstract: A method for implanting a lead includes inserting a needle into the patient; inserting a lead blank through the needle; steering the lead blank to, or near, a lead implantation site; removing the needle from the patient and leaving the lead blank; advancing a flexible sheath over the lead blank after removing the needle; removing the lead blank from the patient and leaving the flexible sheath; inserting a lead through the flexible sheath, after removing the lead blank, and implanting the lead at the lead implantation site; and removing the flexible sheath. The flexible sheath can also be used for explanting a lead and, optionally, implanting a new lead.

Abstract: A connector assembly includes a lead with a lead body having proximal and distal portions. The lead body defines a longitudinal axis. Terminals are disposed along the proximal portion and a proximal tip is attached thereto. The proximal tip defines an aperture that is non-parallel to the longitudinal axis. The connector assembly further includes a connector having a connector body, a connector lumen, and connector contacts disposed within the connector body. The connector body includes a fastener aperture proximal to all of the connector contacts and intersecting the connector lumen. The fastener aperture and the aperture of the proximal tip align when the proximal portion is fully received within the connector lumen. At least one of the apertures includes internal threading. The connector assembly also includes a threaded fastener for insertion into the apertures to secure the lead to the connector.

Abstract: A lead anchor may include a deformable body defining a lead passageway for receiving a lead. A lead retainer may be formed from a rigid material that is disposed in the body and that includes first and second retaining elements disposed around a portion of the lead passageway. First and second tool lumens may extend between an outer surface of the body and the first and second retaining elements, respectively. The retaining elements may be biased to exert a compressive force against a portion of a lead disposed in the lead passageway to resist axial movement of the lead relative to the lead anchor. The lead anchor may be configured so that a tool inserted into the first and second tool lumens can separate the first retaining element from the second retaining element to facilitate insertion or removal of the portion of the lead from the lead passageway.

Abstract: A medical device kit includes a tunneling tool configured to form a tunnel through patient tissue for receiving an electrical stimulation lead. The tunneling tool includes a tunneling-tool body having an elongated shape with a proximal portion and a distal portion. The tunneling-tool body is formed from a material configured to be manually bent prior to insertion into patient tissue to conform to an anatomical contour through which the tunnel is to extend. A blunt tip is disposed at the distal portion. The blunt tip is configured to tunnel through patient tissue. A tunneling-tool suture-receiving element is disposed along the proximal portion of the tunneling-tool body. The tunneling-tool suture-receiving element is configured to receive a suture extendable along the tunnel formed by the tunneling tool.

Abstract: A connector assembly includes a receptacle body that defines a portion of a connector lumen and further includes connector contacts disposed within the receptacle body along the connector lumen. The connector assembly further includes a rotational member that defines another portion of the connector lumen and includes a head portion and an elongated portion. The elongated portion defines an inner surface and an outer surface. The outer surface is rotatably coupled to the receptacle body. Fastener threading is disposed along at least a portion of the inner surface of the elongated portion. The receptacle body and rotational member are configured and arranged to receive a portion of a lead or a lead extension in the connector lumen.

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: 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: A lead anchor includes a lead passageway defined along a central body and configured to receive a lead. The central body includes a twistable region that reversibly twists and stretches. First and second hubs are coupled to opposing ends of the central body. The first hub is rotatable relative to the second hub about the central body. Rotation of the first hub relative to the second hub causes twisting of the twistable region. When a lead is inserted into the lead passageway and the twistable region is twisted into a twisted configuration the central body compresses against the lead to retain the lead within the lead passageway. A locking mechanism transitions the hubs between an unlocked position, where the first hub is rotatable relative to the second hub, and a locked position, where the hubs resist rotation relative to one another.