Systems and methods for improving headache pain

Abstract

Methods and systems for improving headache pain by using feedback mechanisms are provided.

1 . A closed-loop therapy delivery system for improving headache pain in a patient suffering therefrom comprising:
 an electrode device sized and dimensioned to deliver a stimulation signal to a dorsal nasal nerve structure;   a power source in electrical communication with the electrode device;   a sensor configured to sense a physiological parameter associated with the headache pain and generate a sensor signal based on the physiological parameter, the physiological parameter being tearing; impedance of tissue surrounding the dorsal nasal nerve structure; an electrically evoked signal; biometric data; or a combination thereof; and   a controller in electrical communication with the electrode device and the sensor, the controller programmed to generate a drive signal to automatically control placement of the electrode, stimulation parameters delivered by the electrode device, or both based on the sensor signal to improve the patient's headache pain.   
     
     
         2 . The closed-loop therapy delivery system of  claim 1 , wherein the physiological parameter is tearing and the sensor is a moisture sensor. 
     
     
         3 . The closed-loop therapy system of  claim 1 , wherein the physiological parameter is impedance of tissue surrounding the dorsal nasal nerve structure. 
     
     
         4 . The closed-loop therapy delivery system of  claim 1 , wherein the physiological parameter is an electrically evoked signal. 
     
     
         5 . The closed-loop therapy delivery system of  claim 1 , wherein the biometric data is sleep of the patient and the sensor is a pressure sensor or a motion sensor. 
     
     
         6 . The closed-loop therapy delivery system of  claim 1 , wherein the biometric data is a locomotor activity of the patient and the sensor is an accelerometer. 
     
     
         7 . A method for improving headache pain in a patient suffering therefrom comprising:
 inserting in the patient an electrode device sized and dimensioned to deliver a stimulation signal to a dorsal nasal nerve structure, the stimulation signal having stimulation parameters;   sensing a physiological parameter associated with the headache pain, the physiological parameter being tearing; impedance of tissue surrounding the dorsal nasal structure; an electrically evoked signal; biometric data; or a combination thereof;   automatically controlling placement of an electrode device adjacent to the dorsal nasal structure, stimulation parameters delivered by the electrode device to the dorsal nasal structure, or both based on the sensed physiological parameter, wherein the sensing and controlling steps are performed intra-operatively; and   delivering a stimulation signal via the electrode device to the dorsal nasal structure to improve the patient's headache pain.   
     
     
         8 . The method of  claim 7 , further comprising delivering a plurality of stimulation pulses to tissue adjacent to a dorsal nasal nerve structure before the sensing step. 
     
     
         9 . The method of  claim 7 , wherein the sensed parameter is tearing and wherein:
 sensing the physiological parameter comprises detecting when at least one of the plurality of stimulation pulses elicits tearing in the patient; and   wherein automatically controlling placement of the electrode device, the stimulation parameters delivered by the electrode device, or both is based on when the at least one of the plurality of stimulation pulses elicits tearing in the patient.   
     
     
         10 . The method of  claim 7 , wherein the sensed parameter is an electrically evoked signal that is a sensory action potential (SAP) or an electrically evoked compound action potential (ECAP) in response to delivery of the plurality of stimulation pulses and wherein:
 sensing the physiological parameter comprises detecting the frequency of an SAP signal or an ECAP signal indicating activation of A-delta fibers and C fibers of the electrically evoked signal; and   wherein automatically controlling placement of the electrode device, the stimulation parameters delivered by the electrode device or both is based on when the frequency of the SAP signal or an ECAP signal increases above a pre-determined threshold value.   
     
     
         11 . The method of  claim 7 , wherein the sensed parameter is impedance of tissue surrounding the dorsal nasal nerve structure and wherein:
 sensing the physiological parameter comprises detecting when at least one of the plurality of stimulation pulses increases the impedance of the tissue above a pre-determined threshold value; and   wherein automatically controlling placement of the electrode device, the stimulation parameters delivered by the electrode device or both is based on when the at least one of the plurality of stimulation pulses increases the impedance of the tissue above the pre-determined threshold value.   
     
     
         12 . The method of  claim 7 , wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalafine fossa (PPF). 
     
     
         13 . The method of  claim 7 , wherein the dorsal nasal nerve structure is a sphenopalatine ganglion (SPG), a sphenopalatine nerve (SPN), a vidian nerve (VN), a greater petrosal nerve (GPN), a lesser petrosal nerve, a deep petrosal nerve (DPN), a nasopalatine nerve, a greater palatine nerve, an inferior posterior lateral nasal branch of the greater palatine nerve, a lesser palatine nerve, or a superior maxillary nerve. 
     
     
         14 . A method for improving headache pain in a patient suffering therefrom comprising:
 inserting in the patient an electrode device sized and dimensioned to deliver a stimulation signal to a dorsal nasal nerve structure, the stimulation signal having stimulation parameters;   sensing a physiological parameter associated with the headache pain, the physiological parameter being tearing; impedance of tissue surrounding a dorsal nasal nerve structure; an evoked electrical signal; biometric data; or a combination thereof; and   automatically controlling stimulation of the dorsal nasal nerve structure by initiating delivery of the stimulation signal, adjusting the stimulation parameters of the stimulation signal, or both based on the sensed physiological parameter to improve the patient's headache pain, wherein the sensing and controlling steps are performed post-operatively.   
     
     
         15 . The method of  claim 14 , wherein the sensed physiological parameter is tearing and wherein:
 sensing the physiological parameter comprises determining whether the patient is tearing; and   automatically controlling stimulation of the dorsal nasal nerve structure comprises initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal, if necessary, to decrease tearing in the patient.   
     
     
         16 . The method of  claim 14 , wherein the sensed physiological parameter is impedance and wherein:
 sensing the physiological parameter comprises measuring the impedance of the tissue surrounding the dorsal nasal nerve structure; and   automatically controlling stimulation of the dorsal nasal nerve structure comprises determining if the impedance exceeds a pre-determined threshold value and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the impedance exceeds the pre-determined threshold value.   
     
     
         17 . The method of  claim 14 , wherein the sensed physiological parameter is an evoked electrical potential that is a SAP signal or an ECAP signal and wherein:
 sensing the physiological parameter comprises detecting the frequency of the SAP signal or the ECAP signal indicating activation of A-delta fibers and C fibers; and   automatically controlling stimulation of the dorsal nasal nerve structure comprises adjusting the stimulation parameters of the stimulation signal to decrease the frequency of the SAP signal or the ECAP signal.   
     
     
         18 . The method of  claim 14 , wherein the sensed physiological parameter is biometric data that is sleep or locomotor activity of the patient and wherein:
 sensing the physiological parameter comprises detecting the pattern of sleep or the level of locomotor activity of the patient; and   automatically controlling stimulation of the dorsal nasal nerve structure comprises determining if the pattern or level is different than a pre-determined threshold value for the patient and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the pattern or level is different than the pre-determined threshold value.   
     
     
         19 . The method of  claim 14 , wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatine fossa (PPF). 
     
     
         20 . The method of  claim 14 , wherein the dorsal nasal nerve structure is a SPG, a (SPN) (also called the “pterygopalatine nerve”), a vidian nerve (VN) (also called “the nerve of the pterygoid canal”), a greater petrosal nerve (GPN), a lesser petrosal nerve, a deep petrosal nerve (DPN), or a branch thereof (e.g., a nasopalatine nerve, a greater palatine nerve, an inferior posterior lateral nasal branch of the greater palatine nerve, a lesser palatine nerve, or a superior maxillary nerve. 
     
     
         21 .- 24 . (canceled)