Percutaneous lead
a percutaneous lead and nerve fiber technology, applied in the field of percutaneous lead, can solve the problems of difficulty in the useability of high-frequency electrical stimulation, uncomfortable sensation, uncomfortable motor contraction, etc., and achieve the effect of facilitating complete, or near complete, blockage of nerve conduction
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example # 1
EXAMPLE #1
[0403]FIG. 27 demonstrates the sensory response in an able-bodied subject to a percutaneously delivered high-frequency electrical stimulation. The sensations are consistent with the onset response elicited by high-frequency stimulation of a sensory nerve. An S8 (Abbott) electrode was used to stimulate the saphenous nerve at a site 5-to-10 cm proximal to the ankle. The stimulation consisted of a constant-current, 10 kHz sinusoidal waveform, and it was delivered for a period of 20 seconds at various amplitudes, including 4 mA (A—see reference number 2704), 6 mA (B—see reference number 2706), 10 mA (C—see reference number 2708), and 15 mA (D—see reference number 2710). The subject verbally described the quality of the evoked sensations (e.g. light-touch or pain) and indicated the intensity of the sensation on an 11-point scale: levels 1 and 2 defined tactile sensation, level 3 defined the pain threshold, and levels 4-10 indicated a mild-to-severe painful sensation.
[0404]FIG. ...
example # 2
EXAMPLE #2
[0413]To determine if the onset response experienced when a 15-mA stimulation was delivered to the saphenous nerve could be minimized or eliminated, various ramping conditions were tested where the amplitude was allowed to gradually increase to the 15-mA level rather than being immediately set to 15-mA, after which time the 15-mA stimulation was delivered for a time period of 20 seconds. Specifically, the data from the 15-mA stimulation from Example #1 where no ramping was utilized was compared to two different ramping rates—(1) 1 milliamp / second and (2) 0.5 milliamps / second.
[0414]The results are shown in FIGS. 28A-28C and Table 2 below.
TABLE 2PeakSensationResponsePeakOnset-Amplitude(0 to 8AreaOnsetLatencyOffsetAmp(mA)Scale)(mA * s)(seconds)(seconds)(seconds)(mA)157.5458.740.392.5210.87NA(no ramp)(±0.27)(±4.82)(±0.03)(±0.67)(±0.36)150.817.085.8916.5620.675.3(1 mA / s(±0.02)(±0.94)(±0.38)(±2.35)(±1.78)(±0.26)ramp)15N / AN / AN / AN / AN / AN / A(0.5 mA / sramp)
[0415]Table 2 shows an averag...
example # 3
EXAMPLE #3
[0420]The following results shows the ability to block acute pain sensations with high-frequency electrical stimulation delivered in a percutaneous fashion.
[0421]FIGS. 29A and 29B are diagrams of experimental results illustrating sensory responses to a sinusoidal waveform at various levels delivered percutaneously to the saphenous nerve, while pain inducing electrical stimulation was concurrently applied to the subject. Specifically, FIGS. 29A and 29B demonstrate the effect of high-frequency electrical stimulation in blocking acute pain sensations in 2 able-bodied subjects. In the experiment corresponding to FIG. 29A, a pain eliciting electrical stimulation (9 pulses train, 500 Hz, 1 millisecond pulse width, about 30 mA amplitude, inter-train interval of 4 seconds) was delivered to the subject's foot over-top of the saphenous nerve to elicit painful sensations to simulate / cause acute pain. Then, and as shown in FIG. 29A, a high-frequency (10 kHz) electrical stimulation was...
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