The design of and chronic tissue response to a composite nerve electrode with patterned stiffness.

OBJECTIVE: As neural interfaces demonstrate success in chronic applications, a novel class of reshaping electrodes with patterned regions of stiffness will enable application to a widening range of anatomical locations. Patterning stiff regions and flexible regions of the electrode enables nerve reshaping while accommodating anatomical constraints of various implant locations ranging from peripheral nerves to spinal and autonomic plexi. APPROACH: Introduced is a new composite electrode enabling patterning of regions of various electrode mechanical properties. The initial demonstration of the composite's capability is the composite flat interface nerve electrode (C-FINE). The C-FINE is constructed from a sandwich of patterned PEEK within layers of pliable silicone. The shape of the PEEK provides a desired pattern of stiffness: stiff across the width of the nerve to reshape the nerve, but flexible along its length to allow for bending with the nerve. This is particularly important in anatomical locations near joints or organs, and in constrained compartments. We tested pressure and volume design constraints in vitro to verify that the C-FINE can attain a safe cuff-to-nerve ratio (CNR) without impeding intraneural blood flow. We measured nerve function as well as nerve and axonal morphology following 3 month implantation of the C-FINE without wires on feline peripheral nerves in anatomically constrained areas near mobile joints and major blood vessels in both the hind and fore limbs. MAIN RESULTS: In vitro inflation tests showed effective CNRs (1.93 ± 0.06) that exceeded the industry safety standard of 1.5 at an internal pressure of 20 mmHg. This is less than the 30 mmHg shown to induce loss of conduction or compromise blood flow. Implanted cats showed no changes in physiology or electrophysiology. Behavioral signs were normal suggesting healthy nerves. Motor nerve conduction velocity and compound motor action potential did not change significantly between implant and explant (p > 0.15 for all measures). Axonal density and myelin sheath thickness was not significantly different within the electrode compared to sections greater than 2 cm proximal to implanted cuffs (p > 0.14 for all measures). SIGNIFICANCE: We present the design and verification of a novel nerve cuff electrode, the C-FINE. Laminar manufacturing processes allow C-FINE stiffness to be configured for specific applications. Here, the central region in the configuration tested is stiff to reshape or conform to the target nerve, while edges are highly flexible to bend along its length. The C-FINE occupies less volume than other NCEs, making it suitable for implantation in highly mobile locations near joints. Design constraints during simulated transient swelling were verified in vitro. Maintenance of nerve health in various challenging anatomical locations (sciatic and median/ulnar nerves) was verified in a chronic feline model in vivo.

Selective activation of the human tibial and common peroneal nerves with a flat interface nerve electrode.

OBJECTIVE: Electrical stimulation has been shown effective in restoring basic lower extremity motor function in individuals with paralysis. We tested the hypothesis that a flat interface nerve electrode (FINE) placed around the human tibial or common peroneal nerve above the knee can selectively activate each of the most important muscles these nerves innervate for use in a neuroprosthesis to control ankle motion. APPROACH: During intraoperative trials involving three subjects, an eight-contact FINE was placed around the tibial and/or common peroneal nerve, proximal to the popliteal fossa. The FINE's ability to selectively recruit muscles innervated by these nerves was assessed. Data were used to estimate the potential to restore active plantarflexion or dorsiflexion while balancing inversion and eversion using a biomechanical simulation. MAIN RESULTS: With minimal spillover to non-targets, at least three of the four targets in the tibial nerve, including two of the three muscles constituting the triceps surae, were independently and selectively recruited in all subjects. As acceptable levels of spillover increased, recruitment of the target muscles increased. Selective activation of muscles innervated by the peroneal nerve was more challenging. SIGNIFICANCE: Estimated joint moments suggest that plantarflexion sufficient for propulsion during stance phase of gait and dorsiflexion sufficient to prevent foot drop during swing can be achieved, accompanied by a small but tolerable inversion or eversion moment.

Influencing behavior to improve attendance at occupational therapy in a psychiatric setting.

In order to increase attendance at occupational therapy of acute psychiatric patients, two reinforcement procedures were tried: Procedure 1 used prompting and social reinforcement, where Procedure 2, in addition, used a positive reinforcer. The two procedures increased both the attendance and the percentage of time used significantly when compared to baseline. The results are discussed in terms of applications and consistency with other findings.