JP-2022539172-A5 -

Dates

Publication Date

20230502

Application Date

20200630

Description

Devices 10 and 110 may include multiple channels and multiple electrode leads/contacts to provide blocking and excitatory stimuli so that devices 10 and 110 can induce urination, defecation, and/or retention through the application of stimulation at various times, locations, and intensities. Stimulation parameters and electrode lead/contact arrangements for inducing such physiological effects are disclosed in U.S. Patent No. 9,623,243, the entirety of which is incorporated herein by reference. However, to put it simply, for example, devices 10, 110 as described herein, whether implantable, wearable, or otherwise external, may include multiple channels, one (or more) channels for providing block stimuli as described herein, and one (or more) channels for providing stimuli that cause contraction of the EUS or anal sphincter (e.g., stimuli at 0.5 Hz to 15 Hz) and/or stimuli that cause contraction of the bladder or colon/rectum (e.g., 15 Hz to 50 Hz), so that the device can control urination and/or defecation. Devices 10, 110 may include, for example, multiple channels for providing block stimuli as described herein to both pudendal nerves (e.g., the two branches of the pudendal nerve on opposite sides of the body). Devices useful for such procedures, such as those described in U.S. Patent No. 9,623,243, which have three output channels, can be used in a manner that includes: applying an electrical signal to a first point on the patient's pudendal nerve or its branch, the electrical signal having an amplitude and frequency capable of producing a reflex that results in one or both bladder and rectal contractions; and applying an ultrathreshold electrical block signal (as described herein) distal to the first point on the patient's pudendal nerve or its branch and/or on the opposite pudendal nerve or its branch, the blocking electrical signal having an amplitude and frequency capable of blocking pudendal nerve conduction to suppress contraction of one or both of the patient's external urethral sphincter and anal sphincter. The stopping and starting of stimulation can be repeated multiple times to induce bladder or colon/rectal contractions when the pudendal nerve is blocked and the EUS and/or anal sphincter are relaxed, until the bladder or colon is completely empty. The present invention is as follows: [1] A method for blocking a nerve or neuron, comprising applying an electrical stimulus to the nerve or neuron, wherein the electrical stimulus is at an intensity above the excitation threshold of the nerve or neuron for a sufficient time to cause a block of nerve conduction or neuronal excitation. [2] The method according to [1], wherein the electrical stimulation is delivered at an intensity at least five times the excitation threshold of the nerve or neuron, and optionally the intensity is 0.01 mA to 100 mA and/or 1 mV to 500 V, and optionally 0.5 mA to 10 mA. [3] The method according to [1] above, wherein the electrical stimulation is delivered at a frequency of 1 Hz to less than 4 kHz, or 1 Hz to 1.5 kHz, or 1 Hz to 1.3 kHz, and optionally 100 Hz to 1 kHz, and optionally 100 Hz to 500 Hz. [4] The method according to [1] above, wherein the electrical stimulation is delivered for 5 seconds to 14 days, 1 minute to 14 days, optionally 2 minutes to 2 hours, optionally 1 minute to 7 days, optionally 1 minute to 5 days, optionally 2 minutes to 5 minutes, optionally 5 seconds to 90 seconds. [5] The method according to [1], wherein the electrical stimulation causes a block of nerve conduction or neuronal excitation for at least 10 seconds after the cessation of the electrical stimulation. [6] The method according to [1] above, wherein the electrical stimulation includes a biphasic electrical pulse. [7] The method according to [6], wherein the two-phase pulse is symmetrical between the positive phase and the negative phase of the two-phase pulse. [8] The method according to [6], wherein the two-phase pulse is asymmetrical between the positive phase and the negative phase of the two-phase pulse. [9] The method according to [1], wherein the electrical stimulation includes a biphasic electrical pulse in charge equilibrium. [10] The method according to [1], further comprising, once a block of nerve conduction or neuronal excitation is achieved, stopping the application of electrical stimulation for at least 10 seconds, optionally at least 1 minute, optionally at least 5 minutes, 10 minutes, 15 minutes, 30 minutes, or 180 minutes, during which the block of nerve conduction or neuronal excitation is maintained, and after the end of this period, restarting electrical stimulation of the nerve or neuron at the same or different intensity and/or the same or different frequency to continue or prolong the block of nerve conduction or neuronal excitation. [11] The method according to [1], further comprising maintaining the block once a block of nerve conduction or neuronal excitation is achieved by changing the intensity and/or fre