US 12,263,344 B2
Control system for an implantable stimulating device for stimulating a vagus nerve
Pascal Doguet, Mont-Saint-Guibert (BE); Marie Dautrebande, Mont-Saint-Guibert (BE); Yohan Botquin, Mont-Saint-Guibert (BE); and Gregory Thiebaut, Mont-Saint-Guibert (BE)
Assigned to Synergia Medical, Mont-Saint-Guibert (BE)
Appl. No. 17/312,489
Filed by Synergia Medical, Mont-Saint-Guibert (BE)
PCT Filed Dec. 18, 2018, PCT No. PCT/EP2018/085485
§ 371(c)(1), (2) Date Jun. 10, 2021,
PCT Pub. No. WO2020/125948, PCT Pub. Date Jun. 25, 2020.
Prior Publication US 2022/0054841 A1, Feb. 24, 2022
Int. Cl. A61N 1/372 (2006.01); A61N 1/05 (2006.01); A61N 1/36 (2006.01); A61N 5/06 (2006.01)
CPC A61N 1/36139 (2013.01) [A61N 1/0556 (2013.01); A61N 1/36053 (2013.01); A61N 1/36167 (2013.01); A61N 1/37247 (2013.01); A61N 5/0622 (2013.01); A61N 2005/0626 (2013.01); A61N 2005/063 (2013.01); A61N 2005/0651 (2013.01)] 14 Claims
OG exemplary drawing
 
1. A kit of parts for the control of a delivery of an electric or electromagnetic pulse to a patient's vagus nerve by an implanted stimulating device, said kit of parts comprising:
(a) an implantable stimulating device comprising:
a vagus nerve coupling unit comprising one or more electrodes and/or an optrode mounted on an insulating support forming a cuff configured for being coupled directly to the patient's vagus nerve (Vn),
an encapsulation unit configured for being subcutaneously implanted at a location separated from the vagus nerve coupling unit, and comprising a housing enclosing,
an energy pulse generator, for delivering energy pulses including electrical or optical energy,
a source of power for activating the energy pulse generator,
an implanted controller configured for instructing the energy pulse generator to deliver energy pulses to the vagus nerve coupling unit, and
an implanted receiver for receiving signals from an external emitter,
an implanted energy transfer unit comprising one or more electrical conductors and/or optical fibres for transferring electrical and/or optical energy between the energy pulse generator of the encapsulation unit and the vagus nerve coupling unit;
(b) an external controller device comprising:
a laryngeal electrode unit comprising laryngeal electrodes configured for being coupled to the patient's skin on their neck at a level that corresponds to the patient's laryngeal region (Lx) for measurement of laryngeal electrical activity at the patient's laryngeal region, and
an external energy transfer unit comprising one or more electrical conductors or optical fibres for transferring an electrical or optical signal from the laryngeal electrode unit to an external control unit or to an intermediate controller in communication with the external control unit, the electrical or optical signal being representative of the laryngeal electrical activity measured at the laryngeal region: wherein
the external control unit comprises:
a setting unit for entering control pulse parameters of a control energy pulse;
an external emitter configured for sending a signal to the implanted receiver instructing the implanted controller to instruct the energy pulse generator to deliver to the vagus nerve coupling unit one or more control energy pulses defined by the control pulse parameters entered in the setting unit; and
a converter converting electrical or optical signals transferred by the external energy transfer unit into a visual or acoustic display indicative of the intensity of the laryngeal electrical activity measured at the laryngeal region; and
wherein the external control unit is configured for saving a trigger time, t0, defined as a time the signal was sent by the external emitter to the implanted receiver to deliver the one or more control energy pulses and using t0 to estimate within a narrow time window, ±δt, a time, tlx, when an electrical activity caused by the delivery of a control energy pulse of the one or more control energy pulses is detectable at the laryngeal region.