APPARATUSES AND METHODS FOR SETTING AN ELECTRICAL DOSE
Methods and apparatuses (e.g., devices, systems, etc.) for applying a therapeutic dose of electrical energy from a nerve cuff on the nerve to modulate nerve function, including reducing pain, may include using a normalized treatment dose value (or range of values) indicating a target therapeutic charge dose to be applied. These apparatuses and methods may use the impedance value of the nerve at the nerve cuff as well as the cross-sectional area of the region of the nerve at least partially surrounded by the nerve cuff in conjunction with the target normalized treatment dose value(s) to determine the parameters for applied energy. In particular, the parameters may be those needed to achieve high-frequency nerve block at the target normalized treatment dose value(s).
1 . A system for applying a high-frequency nerve block, the system comprising:
a nerve cuff comprising one or more electrodes, wherein the nerve cuff is configured to at least partially surround a region of a nerve;
a pulse generator configured to generate a high-frequency signal having a pulse profile;
a controller configured to determine the pulse profile based on a normalized treatment dose value, a cross-sectional area of the region of the nerve that is at least partially surrounded by the nerve cuff, and an impedance measured from the one or more electrodes, wherein the controller is configured to drive the pulse generator to deliver the high-frequency signal having the pulse profile from the one or more electrodes.
2 . The system of claim 1 , further comprising a memory accessible by the controller, the memory configured to store the normalized treatment dose value and/or the cross-sectional area of the region of the nerve that is at least partially surrounded by the nerve cuff.
3 . The system of claim 1 , wherein the pulse generator is configured to generate the high-frequency signal having a frequency of 1 kHz or greater.
4 . The system of claim 1 , wherein the pulse generator is configured to generate the high-frequency signal having a frequency of between 1 kHz and 100 kHz.
5 . The system of claim 1 , further comprising a housing enclosing the controller, memory and pulse generator.
6 . The system of claim 1 , wherein the controller is implantable.
7 . The system of claim 1 , wherein the controller is external and wirelessly communicates with an implant controller coupled to the pulse generator.
8 . The system of claim 1 , wherein the controller is configured to calculate the cross-sectional area from an indicator of the cross-sectional area received by the controller.
9 . The system of claim 1 , further comprising an input configured to receive an indicator of the cross-sectional area of the region of the nerve that is at least partially surrounded by the nerve cuff.
10 . The system of claim 1 , wherein the normalized treatment dose value is between 0.1 and 5 μC/phase/cm 2 .
11 . The system of claim 1 , further comprising an external controller configured to signal the controller to deliver the high-frequency signal.
12 . The system of claim 1 , wherein the pulse profile comprises one or more of: pulse width, pulse amplitude, pulse frequency, and pulse burst duration.
13 . The system of claim 1 , further comprising a lead coupling the pulse generator to the nerve cuff.
14 . The system of claim 1 , further comprising an impedance sensing sub-system configured to determine the impedance measured from the one or more electrodes.
15 . A system for applying a high-frequency nerve block, the system comprising:
an implantable nerve cuff comprising one or more electrodes, wherein the nerve cuff is configured to at least partially surround a region of a nerve;
a pulse generator configured to generate a high-frequency signal having a pulse profile;
a memory storing a normalized treatment dose value and an indicator of cross-sectional area of the region of the nerve that is at least partially surrounded by the nerve cuff;
a controller configured to determine the pulse profile based on the normalized treatment dose value, a cross-sectional area of the region of the nerve that is at least partially surrounded by the nerve cuff, and an impedance measured from the one or more electrodes, wherein the controller is configured to drive the pulse generator to deliver the high-frequency signal having the pulse profile from the one or more electrodes.
16 . A method of applying a high-frequency nerve block to treat pain, the method comprising:
determining or receiving an indicator of a cross-sectional area of a region of a nerve at least partially surrounded by a nerve cuff having one or more electrodes;
determining an impedance value from one or more of the electrodes;
determining, in a controller, a pulse profile based on a normalized treatment dose value, the cross-sectional area of the region of the nerve at least partially surrounded by the nerve cuff, and the impedance value; and
applying a high-frequency signal having the pulse profile to the nerve.
17 . The method of claim 16 , further comprising applying the nerve cuff at least partially around the nerve.
18 . The method of claim 16 , wherein the high-frequency signal has a frequency of 1 kHz or greater.
19 . The method of claim 16 , wherein the high-frequency signal has a frequency of between 1 kHz and 100 kHz.
20 . The method of claim 16 , wherein the normalized treatment dose value is between 0.1 and 5 μC/phase/cm 2 .
21 . The method of claim 16 , wherein the normalized treatment dose value is between 0.5 and 4 μC/phase/cm 2 .
22 . The method of claim 16 , further comprising estimating the cross-sectional area of the region of a nerve at least partially surrounded by the nerve cuff from the indicator of the cross-sectional area of the region.
23 . The method of claim 16 , wherein determining the indicator of the cross-sectional area of the region of a nerve comprises measuring a circumference or a diameter of the region of the nerve that is or will be at least partially surrounded by the nerve cuff.
24 . The method of claim 16 , further comprising receiving a signal from a user to apply the high-frequency signal having the pulse profile to the nerve.
25 . The method of claim 16 , wherein determining the pulse profile comprises determining one or more of: pulse width, pulse amplitude, pulse frequency, and pulse burst duration.
26 . The method of claim 16 , wherein applying the high-frequency signal comprises applying the high-frequency signal for a treatment duration of greater than 10 minutes.
27 . (canceled)