Apparatus and method for the automated measurement of sural nerve conduction velocity and amplitude

Apparatus for measuring sural nerve conduction velocity and amplitude, the apparatus comprising:

• a housing;
• a stimulation means mounted to the housing for electrically stimulating a human sural nerve;
• a biosensor releasably mounted to the housing, the biosensor comprising a plurality of electrodes for detecting a sural nerve response evoked by the stimulation means;
• an acquisition means mounted to the housing and electrically connected to the biosensor, the acquisition means configured for electrically acquiring the sural nerve response detected by the biosensor;
• a processing means mounted to the housing and electrically connected to the acquisition means, the processing means configured for digitizing, processing and storing an acquired sural nerve response provided by the acquisition means;
• a calculation means mounted to the housing and electrically connected to the processing means, the calculation means configured for calculating the sural nerve conduction velocity and amplitude of a processed sural nerve response provided by the processing means;
• and
• a display means mounted to the housing for displaying a calculated sural nerve conduction velocity and amplitude provided by the calculation means;
• wherein the stimulation means and the biosensor are designed to be placed on a patient's anatomy, in the vicinity of the a sural nerve, by manipulating the housing;
• and
• wherein a recent history of biosensor bit patterns is detected and stored by the apparatus.

A single, fully-integrated, hand-held nerve conduction testing device for measuring sural nerve conduction velocity and amplitude in either leg of a patient, the device comprising a hand-held component and a single-patient use biosensor component, wherein the biosensor component is both physically and electrically connected to the hand-held component to acquire a sural nerve response;

• wherein the hand-held component comprises a housing adapted to be hand-held by a user the housing comprising a handle adapted to be gripped by a hand of the user so as to permit the device to be held against either leg of the patient, and a stimulation means resiliently mounted to the housing for electrically stimulating a human sural nerve in either leg of the patient;
• wherein the single-patient use biosensor component comprises a biosensor unit releasable elastically mounted to the housing, the biosensor unit comprising a plurality of electrodes physically disposed relative to the housing so as to provide first and second laterally-spaced recording channels when the biosensor unit is mounted to the housing for
• acquiring the sural nerve response evoked by the stimulation means in either leg of the patient;
• wherein the hand-held component further comprises an acquisition means carried by the housing and electrically connected to the biosensor unit, the acquisition means configured for electrically acquiring the sural nerve response detected by the first and second laterally-spaced recording channels, a channel determination means for determining which of the first and second laterally-spaced recording channels provides an optimal signal for the sural nerve response, a processing means carried by the housing and electrically connected to the acquisition means and the channel determination means, the processing means configured for digitizing, processing and storing an acquired nerve response provided by the acquisition means and determined by the channel determination means to be the optimal signal for the sural nerve response, a calculation means carried by the housing and electrically connected to the processing means, the calculation means configured for calculating the sural nerve conduction velocity and amplitude of a processed nerve response provided by the processing means, and a display means carried by the housing for displaying a calculated sural nerve conduction velocity and amplitude provided by the calculating means;
• and
• wherein the stimulation means and the biosensor unit are configured to be held against either leg of the patient, in the vicinity of the sural nerve, by the user manipulating the housing using the handle in the same manner regardless of which leg is being tested.

A single, fully-integrated, hand-held nerve conduction testing device for measuring sural nerve conduction velocity and amplitude in either leg of a patient, the device comprising a hand-held component and a single-patient use biosensor component, wherein the biosensor component is both physically and electrically connected to the hand-held component to acquire a sural nerve response;

• wherein the hand-held component comprises a housing adapted to be hand-held by a user, the housing comprising a handle adapted to be gripped by a hand of the user so as to permit the device to be held against either leg of the patient, and a stimulation means resiliently mounted to the housing for electrically stimulating a human sural nerve in either leg of the patient;
• wherein the single-patient use biosensor component comprises a biosensor unit releasably elastically mounted to the housing, the biosensor unit comprising a plurality of electrodes for detecting a sural nerve response evoked by the stimulation means in either leg of the patient;
• wherein the hand-held component further comprises an acquisition means carried by the housing and electrically connected to the biosensor unit, the acquisition means configured for electrically acquiring the sural nerve response detected by the biosensor unit, a processing means carried by the housing and electrically connected to the acquisition means, the processing means configured for digitizing, processing and storing an acquired nerve response provided by the acquisition means, a calculation means carried by the housing and
• electrically connected to the processing means, the calculation means configured for calculating the sural nerve conduction velocity and amplitude of a processed nerve response provided by the processing means, and a display means carried by the housing for displaying a calculated sural nerve conduction velocity and amplitude provided by the calculating means;
• and
• wherein the stimulation means and the biosensor unit are configured to be held against either leg of the patient, in the vicinity of the sural nerve, by the user manipulating the housing using the handle;
• wherein the device further comprises a software control module that automatically detects the connection of the biosensor unit with the housing and initiates proper test setups based on biosensor type;
• wherein said software control module recognizes a predetermined characteristic of the biosensor unit;
• and
• wherein said software control module uses the predetermined characteristic of the biosensor unit to determine the likelihood that the biosensor unit has been re-used across multiple patients through the analysis of a retained biosensor unit characteristic history from each biosensor unit connection.