Early Detection and Treatment of Vascular Dysfunction Using Stimulation Together with Capillary Blood Flow Monitoring

A system for detecting and optionally treating vascular dysfunction in an extremity of a human body, the system comprising a capillary blood flow module and a stimulation module, wherein

• a) the capillary blood flow module comprises:
• i) a heater for applying heat to an area of skin to change the temperature of the skin from a first temperature to a second temperature and for maintaining a constant temperature gradient between the first and second temperatures, and a power source for providing power to the heater;
• ii) a temperature sensor for measuring temperature at the area of skin;
• iii) a controller in communication with the heater and the temperature sensor which [A] operates the heater for maintaining the temperature gradient constant and [B] operates the temperature sensor in a first operative mode and a second operative mode, wherein
• in the first operative mode the temperature sensor measures the first temperature at the area of skin,
• and wherein in the second operative mode, the controller operates the heater to maintain the temperature gradient constant between the first and second temperatures;
• iv) a processor in communication with the controller for determining a capillary blood flow units corresponding to the measured first temperature and the heater power required to maintain the temperature gradient constant;
• and
• b) the stimulation module comprises:
• i) an electrical current waveform generator for generating an electrical stimulation signal;
• ii) a controller for regulating the intensity of the electrical stimulation signal in communication with the electrical current waveform generator;
• and
• iii) at least one electrode and at least one lead, each lead in communication with the controller and a corresponding electrode.

A method for monitoring the healing of a soft tissue injury in an extremity of a human body, the method comprising:

• a) providing a capillary blood flow sensor comprising:
• i) a heater for applying heat to an area of skin to change the temperature of the skin from a first temperature to a second temperature and for maintaining a constant temperature gradient between the first and second temperatures, and a power source for providing a power to the heater;
• and
• ii) a temperature sensor for measuring the first temperature at the area of skin;
• b) determining a capillary blood flow response to a stimulation at an injury in an upper or lower extremity by:
• i) in the absence of the stimulation, measuring a first temperature at an area of skin at the injury with the temperature sensor;
• ii) applying heat to the area of skin with the heater to change the first temperature to a second temperature and maintaining the temperature gradient constant;
• iii) measuring the heater power dissipation required to maintain the temperature gradient constant;
• iv) determining a baseline capillary blood flow as a function of the heater power dissipation based upon a linear relationship of the Fourier equation;
• v) applying a stimulation at a single stimulation intensity at the area of skin and determining the stimulated capillary blood flows as a function of time and a function of the heater power dissipation based upon the linear relationship of the Fourier equation;
• and
• c) comparing the baseline capillary blood flow to the stimulated capillary blood flows and determining a change in capillary blood flow as a function of time to detect vascular dysfunction in the upper or lower extremity.