Reinforced sensing and stimulation leads and use in detection systems
View Patent ↗A reinforced medical electrical lead for neurological applications has a reinforced construction for resisting the detachment of electrodes and lead connection terminals, thereby improving the robustness of the lead and extending the life of the lead by reducing the likelihood that a further surgical procedure will be required to remove the lead for repair or replacement thereof. The present reinforced lead construction maintains the integrity of the electrical connection between the conductor and the respective electrode and lead connection terminal by incorporating several reinforcing features in the lead construction in contrast to conventional lead constructions where it is possible to pull the electrodes and lead connection terminals away from their contact points with relatively little force.
1. A method of fabricating a reinforced medical electrical lead, the method comprising:
providing at least one conductor;
disposing a flexible shaft around the at least one conductor, the at least one conductor having first and second end sections that extend beyond ends of the flexible shaft;
electrically connecting at least one lead connection terminal to the second end section of the least one conductor;
providing a first longitudinal reinforcing sheath, the first reinforcing sheath defining a first longitudinal lumen;
inserting a section of a core member within the first longitudinal lumen at a distal end of the first reinforcing sheath;
disposing a reinforcing sleeve around a length of the reinforcing sheath, the reinforcing sleeve surrounding the inserted section of the core member;
compressing selected sections of the reinforcing sleeve around the first reinforcing sheath and the inserted section of the core member to enhance the rigidity at the distal end and retain the core member in place;
disposing the crimped first reinforcing sheath through an inner channel defined by the first end section of the at least one conductor; and
extending the flexible shaft so that the at least one conductor and the at least one lead connection terminal are at least partially embedded within the flexible shaft.
2. The method of claim 1 , wherein disposing the crimped first reinforcing sheath through an inner channel defined by the first end section of the at least one conductor results in the at least one conductor being helically arranged around the first reinforcing sheath.
3. The method of claim 1 , further comprising:
providing a second longitudinal reinforcing sheath, the second reinforcing sheath defining a second longitudinal lumen;
coupling a proximal end of the second reinforcing sheath to a bushing having a longitudinal bore extending therethrough and in communication with the second longitudinal lumen; and
disposing the second longitudinal reinforcing sheath through the inner channel of the at least one conductor at the second end section thereof.
4. The method of claim 3 , further comprising:
disposing a proximal reinforcing element between the at least one lead connection terminal and the bushing.
5. The method of claim 4 , wherein the proximal reinforcing element comprises an elongated reinforcing cable formed of arranged fibers, and the method further includes:
wrapping and retaining the reinforcing cable around the bushing within a radial groove formed therein and disposing the reinforcing cable within an axial slot formed in the bushing substantially perpendicular to the radial groove, the reinforcing cable serving to enhance the robustness of the proximal portion.
6. The method of claim 1 , further comprising:
molding a relatively rigid distal tip around a head of the core member that extends beyond the distal end of the first reinforcing element.
7. The method of claim 1 , further comprising electrically connecting at least one electrode to the first end section of the at least one conductor, and wherein extending the flexible shaft includes:
injecting a material around the at least one electrode and the at least one lead connection terminal in a mold such that the length of the tubular shaft is extended to surround the first and second end sections of the at least one conductor, resulting in the at least one electrode and the at least one lead connection terminal being partially embedded in the extended flexible shaft.