Abstract: The present application generally relates to neurostimulation systems with stimulation leads and/or stylets with improved malleability and/or flexibility.

Abstract: A method of forming a stimulation lead includes forming an implantable lead body, including helically winding at least one cable about a mandrel to form a coiled cable assembly in a first, restrained state. Helically winding the at least one cable includes applying a tensile force to the at least one cable as the at least one cable is wound about the mandrel. Forming the lead body also includes releasing the tensile force from the at least one cable to allow the coiled cable assembly to release stored mechanical energy and transition from the restrained state to a second, relaxed state in which the coiled cable assembly is substantially free of stored mechanical energy. The method further includes subjecting the lead body to a reflow process by applying heat to the lead body, where the tensile force is released prior to the lead body being subjected to the reflow process.

Abstract: Systems and methods which provide radial exterior weld terminal configurations for medical device leads are described. A radial exterior weld terminal may comprise an annular conductive structure having a radial exterior weld interface feature, wherein a medical device lead may comprise one or more radial exterior weld terminals. A radial exterior weld interface feature may be disposed at an end of the annular conductive structure and may configure the annular conductive structure to accept a non-axially directed portion of a conductive wire for interfacing a conductor with a weld location on an outer surface of the radial exterior weld terminal. The radial exterior weld interface feature may comprise a truncated aperture configured for the non-axially directed portion of conductive wire to traverse from the inner space to the outer surface. The truncated aperture may comprise a dimple member depressed into the interior space of the annular conductive structure.

Abstract: A method of forming a stimulation lead includes forming an implantable lead body, including helically winding at least one cable about a mandrel to form a coiled cable assembly in a first, restrained state. Helically winding the at least one cable includes applying a tensile force to the at least one cable as the at least one cable is wound about the mandrel. Forming the lead body also includes releasing the tensile force from the at least one cable to allow the coiled cable assembly to release stored mechanical energy and transition from the restrained state to a second, relaxed state in which the coiled cable assembly is substantially free of stored mechanical energy. The method further includes subjecting the lead body to a reflow process by applying heat to the lead body, where the tensile force is released prior to the lead body being subjected to the reflow process.

Abstract: Systems and methods which provide a bulkhead anchor configuration in which an anchor body includes flexure finger members and a radial bulkhead operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A first portion of a bulkhead anchor body may comprise a plurality of flexure finger members disposed in a corolla configuration forming an anchor lumen through which a lead body may be inserted. A second portion of the bulkhead anchor body may comprise a radial bulkhead having a flexure profile configured to operatively engage the flexure finger members. A locking mechanism may be used to retain the first and second portions of the bulkhead anchor in their relative positions such that the radial compressive force is maintained upon the lead body indefinitely.

Abstract: Systems and methods which provide a bulkhead anchor configuration in which an anchor body includes flexure finger members and a radial bulkhead operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A first portion of a bulkhead anchor body may comprise a plurality of flexure finger members disposed in a corolla configuration forming an anchor lumen through which a lead body may be inserted. A second portion of the bulkhead anchor body may comprise a radial bulkhead having a flexure profile configured to operatively engage the flexure finger members. A locking mechanism may be used to retain the first and second portions of the bulkhead anchor in their relative positions such that the radial compressive force is maintained upon the lead body indefinitely.

Abstract: Systems and methods which provide retractable anchor configurations for medical device leads are described. A retractable anchor may implement a retractable distention composed of a resilient material. The retractable distention may be distended when in a neutral state and may be contracted when in a biased state. A biasing bulkhead may be configured to receive a bias force sufficient to retract the retractable distention. A stylet may be inserted into an axial lumen of a medical device lead having retractable tip anchor structure and may engage the biasing bulkhead to apply a bias force. A stylet knob may be configured to interface with the stylet and provide bias force to be transferred to the biasing bulkhead of the retractable tip anchor structure. Locking the stylet knob on the medical device lead may maintain the bias force applied to the biasing bulkhead until the stylet knob is unlocked.

Abstract: Systems and methods which provide radial exterior weld terminal configurations for medical device leads are described. A radial exterior weld terminal may comprise an annular conductive structure having a radial exterior weld interface feature, wherein a medical device lead may comprise one or more radial exterior weld terminals. A radial exterior weld interface feature may be disposed at an end of the annular conductive structure and may configure the annular conductive structure to accept a non-axially directed portion of a conductive wire for interfacing a conductor with a weld location on an outer surface of the radial exterior weld terminal. The radial exterior weld interface feature may comprise a truncated aperture configured for the non-axially directed portion of conductive wire to traverse from the inner space to the outer surface. The truncated aperture may comprise a dimple member depressed into the interior space of the annular conductive structure.

Abstract: The present disclosure provides a stimulation lead for providing stimulation signals to nerve tissue and improved methods for constructing and manufacturing such a stimulation lead. The stimulation lead and/or methods includes a lead with a cable disposed within. At each end of the lead body a portion of the cable is exposed, and a metal ferrule is securely attached to the exposed cable portion. An electrode/contact is then securely attached to the metal ferrule such that the electrode covers the metal ferrule, a portion of the lead body, and a transition point where the exposed cable exits the lead body. A tine component may be swaged around a portion of the term end, configured to provide a retaining force against an force acting upon the stimulation lead, while allowing insertion of the stim end of the stimulation lead during implantation, and extraction of the stim end during explantation.

Abstract: The present disclosure provides systems and methods for exogenous neurostimulation. An exogenous neurostimulation system includes an electrode pad comprising a plurality of electrodes configured to be applied to skin of a patient, and a pulse generator communicatively coupled to the electrode pad, the pulse generator operable to generate burst waveforms for delivery to the skin of the patient via the electrode pad.

Abstract: The present disclosure provides systems and methods for exogenous neurostimulation. An exogenous neurostimulation system includes an electrode pad comprising a plurality of electrodes configured to be applied to skin of a patient, and a pulse generator communicatively coupled to the electrode pad, the pulse generator operable to generate burst waveforms for delivery to the skin of the patient via the electrode pad.

Abstract: The present disclosure provides a stimulation lead for providing stimulation signals to nerve tissue and improved methods for constructing and manufacturing such a stimulation lead. The stimulation lead and/or methods includes a lead with a cable disposed within. At each end of the lead body a portion of the cable is exposed, and a metal ferrule is securely attached to the exposed cable portion. An electrode/contact is then securely attached to the metal ferrule such that the electrode covers the metal ferrule, a portion of the lead body, and a transition point where the exposed cable exits the lead body. A tine component may be swaged around a portion of the term end, configured to provide a retaining force against an force acting upon the stimulation lead, while allowing insertion of the stim end of the stimulation lead during implantation, and extraction of the stim end during explantation.

Abstract: Systems and methods which provide a slip ring anchor configuration in which an anchor body includes inelastic members and a fluted elastomeric casing operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A slip ring anchor body may comprise a plurality of inelastic members alternately disposed in flutes of a fluted elastomeric casing portion of the anchor body. The fluted elastomeric casing may form an anchor lumen through which a lead body may be inserted. Once a slip ring anchor is disposed at a desired position axially along the lead body, manipulation of one or more slip rings may be used to cause a radial compressive force to be imparted upon the lead body. A slip ring actuator tool may be used to manipulate a slip ring between unlocked and locked positions.

Abstract: Systems and methods which provide a bulkhead anchor configuration in which an anchor body includes flexure finger members and a radial bulkhead operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A first portion of a bulkhead anchor body may comprise a plurality of flexure finger members disposed in a corolla configuration forming an anchor lumen through which a lead body may be inserted. A second portion of the bulkhead anchor body may comprise a radial bulkhead having a flexure profile configured to operatively engage the flexure finger members. A locking mechanism may be used to retain the first and second portions of the bulkhead anchor in their relative positions such that the radial compressive force is maintained upon the lead body indefinitely.

Abstract: A method of forming a stimulation lead includes forming an implantable lead body, including helically winding at least one cable about a mandrel to form a coiled cable assembly in a first, restrained state. Helically winding the at least one cable includes applying a tensile force to the at least one cable as the at least one cable is wound about the mandrel. Forming the lead body also includes releasing the tensile force from the at least one cable to allow the coiled cable assembly to release stored mechanical energy and transition from the restrained state to a second, relaxed state in which the coiled cable assembly is substantially free of stored mechanical energy. The method further includes subjecting the lead body to a reflow process by applying heat to the lead body, where the tensile force is released prior to the lead body being subjected to the reflow process.

Abstract: Disclosed herein is a lead insertion tool for inserting a lead connector end of an implantable lead into a lead receptacle of a header of an implantable pulse generator, the implantable lead including a lead body extending distally from the lead connector end. The tool includes a lead pathway and an engagement mechanism. The lead pathway extends through the tool and is configured to receive the implantable lead. The engagement mechanism includes an engaged state and a self-biasing non-engaged state. When the engagement mechanism is self-biased into the non-engaged state, the implantable lead is free to displace along the lead pathway. When the engagement mechanism is forced into the engaged state, the lead cannot displace along the lead pathway.

Abstract: A multi-lead stimulation lead connector for facilitating electrical and mechanical connectivity between one or more stimulation leads and a pulse generator, e.g., an EPG used in a test stimulation system. One or more cam lock assemblies are disposed in a housing, each cam lock assembly comprising a cam knob and a cam shaft and having a longitudinal channel defined therein for accepting a proximal end of a respective stimulation lead, the proximal end having a plurality of terminal contact electrodes. By actuating a rotational movement of the cam knob, the cam lock assembly is unlocked in a first direction for guiding the proximal end and locked in a second direction for securely holding the proximal end and effectuating electrical connectivity with a plurality of conductors encapsulated in a cable for interfacing with the EPG.

Abstract: A multi-lead stimulation lead connector for facilitating electrical and mechanical connectivity between one or more stimulation leads and a pulse generator, e.g., an EPG used in a test stimulation system. One or more cam lock assemblies are disposed in a housing, each cam lock assembly comprising a cam knob and a cam shaft and having a longitudinal channel defined therein for accepting a proximal end of a respective stimulation lead, the proximal end having a plurality of terminal contact electrodes. By actuating a rotational movement of the cam knob, the cam lock assembly is unlocked in a first direction for guiding the proximal end and locked in a second direction for securely holding the proximal end and effectuating electrical connectivity with a plurality of conductors encapsulated in a cable for interfacing with the EPG.

Abstract: A neurostimulation stimulation lead and method of fabrication are provided. First and second electrode sets include segmented electrodes joined with linking portions, bodies having a mandrel lumen, and a wire retention fixture. The second electrode set includes a wire pass through channel. The mandrel lumens, wire retention fixtures and wire pass through channel are monolithically formed in the corresponding bodies. The first and second wire filers are directly seated into the corresponding wire retention fixtures, such that the wire retention fixtures frictionally secure and retain the first and second wire filers. The first and second electrode sets are arranged in line with one another such that an intermediate portion of the first wire filer extends through the wire pass through channel in the second electrode set. The method removes the linking portions of the first and second electrode sets to unlink the segmented electrodes.

Abstract: A cannula is provided that includes a core and a peelable outer layer. The core includes multiple longitudinal cannula body segments that collectively define a lumen and are generally maintained in position by the peelable outer layer. To remove the cannula from a patient, the outer peelable layer may be peeled and removed, thereby enabling the cannula segments to be separated and removed from the patient.