NEUROSTIMULATORS AND RELATED SYSTEMS AND METHODS
One aspect of the present disclosure relates to a system for treating a medical condition in a patient. The system can include a neurostimulator that is in electrical communication with a remote transducer. The neurostimulator can be sized and dimensioned for injection or insertion into a pterygopalatine fossa (PPF) of a patient. The remote transducer, when activated and brought into close proximity to the patient's head, can cause the neurostimulator to deliver an electrical signal to a target neural structure located within the PPF to treat the medical condition.
1 . A system for treating a medical condition in a patient comprising:
a sheath having an inner lumen with a proximal end and a distal end;
a neurostimulator sized and dimensioned for injection or insertion into the pterygopalatine fossa (PPF) of a patient, the neurostimulator comprising a plurality of expandable electrical leads each comprising a plurality of independently selectable electrical contacts, the plurality of expandable electrical leads disposed within the sheath's inner lumen in a non-deployed configuration and splaying radially outward from the distal end of the sheath's inner lumen in a deployed configuration; and
a remote transducer that electrically communicates with and transfers power to the neurostimulator and when activated and brought into close proximity to the patient's head causes the neurostimulator to deliver an electrical signal to a target neural structure located within the PPF to treat the medical condition.
2 . The system of claim 1 , wherein the plurality of expandable electrical leads are sized and dimensioned to partially or fully encapsulate the sphenopalatine ganglion (SPG) in a deployed configuration.
3 . The system of claim 1 , wherein the plurality of expandable electrical leads comprises a proximal end in operable communication with a spring.
4 . The system of claim 3 , further comprising a trigger rod slidably extendable through the inner lumen of the sheath and longitudinally aligned with the spring, the trigger rod configured to compress the spring when urged distally to operably contact the spring.
5 . The system of claim 1 , further comprising an insertion tool having a component configured to engage a complimentary component of the sheath to retract the sheath when the neurostimulator is prepared to assume a deployed configuration.
6 . The system of claim 1 , wherein the neurostimulator is dimensioned for injection or insertion through a hypodermic needle, a catheter, or a catheter-like device.
7 . The system of claim 1 , wherein the neurostimulator further includes one or more tissue fixation devices.
8 . The system of claim 7 , wherein the neurostimulator comprises a neurostimulator body and the tissue fixation devices are suture tabs molded to the neurostimulator body.
9 . The system of claim 1 , wherein the remote transducer is configured as a patch, a wand, a headset or glasses.
10 . The system of claim 9 , wherein the patch includes a skin-contacting/adhering surface.
11 . The system of claim 1 , wherein the remote transducer further comprises:
a replaceable or rechargeable power source; and
a transmit coil, a radiator or a PCB antenna.
12 . The system of claim 1 , further comprising a personal electronic device in electrical communication with the remote transducer, the personal electronic device including software to control one or more stimulation parameters associated with the neurostimulator.
13 . The system of claim 12 , wherein the personal electronic device is a smart-phone or a tablet.
14 . The system of claim 1 , further comprising a programming device configured to deliver stimulation instructions to the remote transducer, the programming device being in electrical communication with the remote transducer and/or the personal electronic device.
15 . The system of claim 14 , wherein the programming device is configured as a dedicated, smart phone-sized unit, or a smart phone accessory dongle.
16 . A method for treating a medical condition in a patient, the method comprising the steps of:
inserting or injecting a sheath into a pterygopalatine fossa (PPF) of the patient, the sheath having an inner lumen with a proximal end and a distal end, the sheath having disposed therein a neurostimulator comprising a plurality of expandable electrical leads each comprising a plurality of independently selectable electrical contacts;
advancing the sheath to a target neural structure in the PPF;
deploying the plurality of expandable electrical leads to splay outwards from the sheath and fully or partially encapsulate the target neural structure; and
activating one or more of the plurality of independently selectable electrical contacts to deliver a therapeutic electrical signal to the target neural structure to treat the medical condition.
17 . The method of claim 16 , further comprising activating one or more of the plurality of independently selectable electrical contacts to determine whether such activation cause paresthesia to a part of the patient's body innervated by the target neural structure.
18 . The method of claim 16 , wherein receiving via injection comprises receiving a neurostimulator via a hypodermic needle, a catheter, or a catheter-like device.
19 . The method of claim 16 , wherein the target neural structure in the PPF is a sphenopalatine ganglion (SPG).
20 . The method of claim 19 , wherein the medical condition is headache pain.