Device and method for neuromodulation

Abstract

The present invention relates to a preoperative test method, to an implantation system ( 20 ) and to an implantation method for implanting a neuroprosthesis in the area of the pubic bone ( 31 ), wherein implantation is ultimately simplified and made more effective directly or indirectly by the subject-matters of the invention.

1 . A preoperative test method for implanting a neuroprosthesis comprising a pacemaker ( 21 ) and an electrode array for the most direct stimulation possible of nerves ( 19 ) in the genital area ( 12 ), the method comprising:
 placing removable electrodes ( 30 ) on the body surface of a genital area of the patient;   inducing in the patient a physical condition exhibiting symptoms to be treated with the neuroprosthesis;   energizing the electrodes ( 30 ) with a test current; and   recording change caused in the symptoms by energization of the electrodes ( 30 ).   
     
     
         2 . The method according to  claim 1 , wherein the electrodes ( 30 ) are adhesive electrodes. 
     
     
         3 . The method according to  claim 1 , wherein the electrodes ( 30 ) are energized with a test current with current pulses of 150 μs to 250 μs in length. 
     
     
         4 . The method according to  claim 3 , wherein the electrodes are energized with a frequency of 10 Hz to 50 Hz. 
     
     
         5 . The method according to  claim 3 , wherein the electrodes are energized with an amplitude of 5 mA to 60 mA. 
     
     
         6 . The method according to  claim 1 , wherein a first electrode ( 30 . 1 ) is placed in the area of the clitoris or of the root of the penis and a second electrode ( 30 . 2 ) is placed laterally offset at the same height. 
     
     
         7 . The method according to  claim 6 , wherein laterally offset placement of the second electrode ( 30 . 2 ) is performed successively on both sides of the body, and upon each placement, at least the method steps of inducing a physical condition exhibiting the symptoms to be treated with the neuroprosthesis, energizing the electrodes ( 30 ) with a test current and recording the change caused in the symptoms by the energization of the electrodes ( 30 ) are executed. 
     
     
         8 . The method according to  claim 7 , wherein each laterally offset placement of the second electrode ( 30 . 2 ) is performed at a different height with respect to the first electrode ( 30 . 1 ), and upon each placement, at least the method steps of inducing a physical condition exhibiting the symptoms to be treated with the neuroprosthesis, energizing the electrodes ( 30 ) with a test current and recording the change caused in the symptoms by the energization of the electrodes ( 30 ) are executed. 
     
     
         9 . The method according to  claim 6 , wherein a multiple electrode comprising a plurality of spatially adjacent and electrically separate and individually controllable individual electrodes is used as the second electrode ( 30 . 2 ) and the method is performed in such a manner that the different electrodes are energized in a temporal order. 
     
     
         10 . The method according to  claim 6 , wherein the first electrode ( 30 . 1 ) is energized as a cathode and the second electrode ( 30 . 2 ) is energized as an anode. 
     
     
         11 . The method according to  claim 1 , wherein the physical symptoms comprise urinary incontinence, fecal incontinence and/or erectile dysfunction. 
     
     
         12 . An implantation system ( 20 ) comprising a curved hollow needle applicator ( 1 ) which can accommodate a tip ( 4 ) in a shaft ( 6 ) surrounding a hollow needle channel, the tip ( 4 ) being comprised by the system and removable at a front end, or which can accommodate a wire electrode means ( 8 ) at the front end, the wire electrode means ( 8 ) being comprised by the system, wherein the hollow needle applicator ( 1 ) comprises a measuring device ( 11 ) by means of which a user can determine how far the wire electrode means ( 8 ) has been introduced into the shaft ( 6 ) of the hollow needle applicator ( 1 ) at the front end. 
     
     
         13 . The system according to  claim 12 , wherein the shaft ( 6 ) of the hollow needle applicator ( 1 ) is equipped with a window ( 10 ). 
     
     
         14 . The system according to  claim 13 , wherein the window is provided with a mark marking a minimum position or a minimum introduction depth of the wire electrode means ( 8 ) into the shaft ( 6 ). 
     
     
         15 . The system according to  claim 12 , wherein the wire electrode means ( 8 ) has a fixing means on a contact portion ( 9 ), the fixing means allowing the wire electrode means ( 8 ) to be fixed to a cartilage and/or bone structure. 
     
     
         16 . The system according to  claim 12 , wherein the wire electrode means ( 8 ) has a mobile fixing means in a shaft portion, the mobile fixing means allowing the wire electrode means ( 8 ) to be fixed to a cartilage and/or bone structure. 
     
     
         17 - 34 . (canceled) 
     
     
         35 . The method according to  claim 5 , wherein the electrodes are energized with an amplitude of 5 mA to 50 mA. 
     
     
         36 . The method according to  claim 6 , wherein the second electrode ( 30 . 2 ) is placed laterally offset at a distance of 2 to 3 cm from an outer labium or at a lateral offset of 2 to 3 cm from the root of the penis. 
     
     
         37 . The method according to  claim 10 , wherein polarity of the first electrode ( 30 . 1 ) and the second electrode ( 30 . 2 ) reverses during energization and the change caused in the symptoms by energization being recorded as a function of polarity of the electrodes ( 30 ). 
     
     
         38 . The system according to  claim 16 , wherein the mobile fixing means is configured in such a manner that it allows movement relative to the hollow needle applicator ( 1 ).