Devices, systems, and methods for non-invasive chronic pain therapy

Abstract

The present disclosure relates to sensing devices, systems, and their methods of use for aiding transcutaneous magnetic stimulation (tMS) therapy, such as for the treatment, alleviation, and the management of pain. The sensing device being configured for determining and measuring the efficacy thereof. Particularly, the present disclosure is directed to providing sensing devices, systems including the same, and their methods of use in identifying and targeting one or more sources of pain, such as chronic neuropathic pain, as well as for facilitating in the treatment thereof.

1 . A transcutaneous sensing and monitoring device for determining a reaction of a nerve to receipt of a magnetic stimulation applied to a target area, the transcutaneous sensing device comprising:
 a housing having a plurality of sets of opposed surfaces offset from one another by a boundary member, one opposed surface of a set of opposed surfaces forming a top surface and a corresponding other of the set of opposed surfaces forming a bottom surface, together the plurality of sets of opposed surfaces and boundary member bounding a cavity, the cavity configured for retaining one or more components of the transcutaneous sensing device;   a first and second extended insulation layer, the first insulation layer being positioned proximate the top surface of the housing and the second insulation layer being positioned proximate the bottom surface of the housing; and   an extended substrate layer positioned between the first and second insulation layers and being configured for determining the reaction of the nerve to receipt of the magnetic stimulation, the substrate layer comprising:
 a plurality of magnetometers positioned along a surface of the substrate layer and being arranged in a grid-like formation having a multiplicity of rows and columns, each magnetometer being configured for detecting the reaction in a nerve fiber to the magnetic stimulation being applied to the target area so as to produce sensed response data, the sensed response data including a first amplitude characterizing the reaction of the nerve fiber to the magnetic stimulation; 
 a printed circuit board coupled with the plurality of magnetometers containing a processing unit, a memory, and a communications module, the processing unit being configured for receiving, processing, and integrating the sensed response data to produce integrated response data and the communications module being configured for transmitting the integrated response data; and 
   an antenna unit for enhancing data collection and transmission, the bottom surface of the housing including an attachment mechanism configured for coupling the transcutaneous sensing and monitoring device to a portion of a subject's body proximate the target area.   
     
     
         2 . The transcutaneous sensing and monitoring device in accordance with  claim 1 , further comprising a plurality of sensing units, each of the plurality of sensing units including at least three magnetometers, wherein each sensor unit is configured for characterizing the first amplitude with regard to one or more of its X, Y, and Z coordinates so as to produce target nerve characterization data. 
     
     
         3 . The transcutaneous sensing and monitoring device in accordance with  claim 2 , wherein the characterizing of the first amplitude comprises determining one or more of a direction and a magnitude, and the target nerve characterization data comprises both direction data and magnitude data from at least one sensing unit. 
     
     
         4 . The transcutaneous sensing and monitoring device in accordance with  claim 3 , wherein at least two of the at least three magnetometers are selected from a different row and column. 
     
     
         5 . The transcutaneous sensing and monitoring device in accordance with  claim 4 , wherein the processing unit is configured for performing one or more of triangulation and trilateration to determine a position of the nerve fiber by integrating the target nerve characterization data from a plurality of sensor units so as to produce integrated target nerve characterization data. 
     
     
         6 . The transcutaneous sensing and monitoring device in accordance with  claim 5 , wherein the transcutaneous sensing and monitoring device is further configured for characterizing a reaction in a non-target nerve fiber to the magnetic stimulation being applied to the target area, so as to produce noise data. 
     
     
         7 . The transcutaneous sensing and monitoring device in accordance with  claim 6 , wherein the producing of integrated targeted nerve characterization data includes removing noise data during the triangulating or trilaterating process. 
     
     
         8 . A system for treating neuropathic pain in a subject's body via the administration of magnetic stimulation, the system comprising:
 a transcutaneous sensing and monitoring device for identifying a nerve to be treated with magnetic stimulation, the transcutaneous sensing and monitoring device comprising:
 a housing having an extended top and bottom surface offset from one another by a bounding member, together the top surface, bottom surface, and bounding member bounding a cavity for retaining one or more components of the transcutaneous sensing device; 
 a plurality of extended insulation layers, a first insulation layer being positioned proximate the top surface and a second insulation layer being positioned proximate the bottom surface; and 
 an extended substrate layer positioned between the plurality of insulation layers, the substrate layer comprising:
 a plurality of sensing elements positioned along one or more surfaces of the substrate layer and being configured for detecting a reaction in one or more nerve fibers to the receipt of a magnetic stimulus being applied to a target area of a subject's body so as to produce response data, 
 
 a printed circuit board coupled with the plurality of sensing elements, containing a processing unit, a memory, and a communications module, the processing unit being configured for receiving and processing the response data to produce processed response data and the communications module being configured for transmitting the processed response data, the processed response data including a characterization of an identified nerve to be treated, and 
 an antenna unit for enhancing data collection and transmission, the bottom surface of the housing including an attachment mechanism configured for coupling the transcutaneous sensing and monitoring device to a portion of the subject's body proximate the target area; and 
   a transcutaneous magnetic stimulation (tMS) application system for delivering focused magnetic stimulation to the identified nerve to be treated with magnetic stimulation, the tMS application system comprising:
 a transcutaneous magnetic stimulation (tMS) application device for delivering focused magnetic stimulation, the tMS application device comprising:
 a housing having an extended body, the extended body including a proximate portion having a proximate end, and a distal portion having a distal end, the extended body defining a cavity for retaining one or more components of the tMS device, 
 an insulated magnetic coil disposed within the cavity of the proximate portion of the extended body of the housing, the magnetic coil having a figure-8 arrangement and including braiding wrapped around the figure-8 portion of the coil, the magnetic coil being configured for generating and delivering a focused magnetic stimulation at a determined pulse rate and having a determined amplitude, the generating of the focused magnetic stimulation being characterized by a voltage and a current, 
 
   a control module, the control module including:
 a communication module for receiving the processed response data and the characterization of the identified nerve, 
 a memory, coupled to the communications module, for storing the processed response data, the characterization of the identified nerve, and one or more treatment protocols, and 
 a processing element, coupled to one or more of the communications module and the memory, the processing element for accessing the processed response data and the characterization of the identified nerve, and determining a treatment protocol, the treatment protocol defining one or more application parameters and one or more delivery characteristics, the one or more application parameters including: 
 a voltage level and a current level for generating a magnetic pulse of the magnetic stimulation, 
 a frequency and duration of the magnetic pulse to be generated, and 
 the one or more delivery characteristics including a set of coordinates defining the nerve to be treated and an orientation for orienting the tMS application device relative to the target area; and 
   a positioning element having a proximal portion including a proximal end, and a distal portion including a distal end, the distal portion being coupled to the transcutaneous magnetic stimulation (tMS) application device proximate the distal end, the positioning element being composed of a plurality of articulating arm members, a plurality of the arm members being coupled together by an automating element, the automating element for positioning and orienting the tMS application device proximate the treatment area in accordance with the orientation of the treatment protocol.   
     
     
         9 . The system in accordance with  claim 8 , wherein a plurality of sensing elements of the transcutaneous sensing and monitoring device comprise magnetometers, the magnetometers having a grid-like configuration including both rows and columns. 
     
     
         10 . The system in accordance with  claim 9 , wherein the plurality of magnetometer sensing elements include at least three magnetometers, wherein any set of three magnetometers from the at least three magnetometers form a sensing unit, the sensing unit being configured for performing one or more of triangulation and trilateration to determine a portion of a target nerve based on its reaction to its receipt of the magnetic stimulus. 
     
     
         11 . The system in accordance with  claim 10 , wherein the triangulation or trilateration of the target nerve involves characterizing a first amplitude produced in the target nerve by its receipt of the magnetic stimulus with regard to one or more of its X, Y, and Z coordinates so as to produce nerve characterization data. 
     
     
         12 . The system in accordance with  claim 11 , wherein the treatment protocol includes instructions for orienting the tMS application device proximate the target area, the orienting of the tMS application device being based on the nerve characterization data such that an orientation of the tMS application device corresponds to an orientation of the target nerve. 
     
     
         13 . The system in accordance with  claim 12 , wherein the positioning element is configured for autonomously positioning and orienting the tMS application device in a determined orientation proximate the target area. 
     
     
         14 . The system in accordance with  claim 13 , wherein the system further comprises a movement sensor for detecting a movement of the target area, whereby any movement of the target area evokes a corresponding movement in the tMS application device so as to maintain its determined orientation to the target nerve. 
     
     
         15 . A system for identifying one or more characteristics of a neuropathic nerve to be targeted with an application of a focused magnetic stimulation so as to ameliorate neuropathic pain experience, the system comprising:
 a transcutaneous sensing and monitoring device having a plurality of sensing elements in the form of a grid including both rows and columns of sensing elements, each sensing element being configured for identifying a reaction of a nerve in response to an applied magnetic stimulus so as to produce raw reaction data, the transcutaneous sensing and monitoring device including a communications module for transmitting the raw reaction data;   a computing device, coupled to the transcutaneous sensing and monitoring device, the computing device being configured for receiving the raw reaction data, evaluating the raw reaction data, and determining one or more characteristics of a neuropathic nerve to be targeted for treatment by application of a magnetic stimulation, the computing device comprising:
 a first processing engine for receiving raw reaction data from a first unit of sensing elements of the transcutaneous sensing and monitoring device, the unit including a first set of at least three sensing elements, the raw reaction data including magnitude data and orientation data from each sensing element of the first unit and characterizing the response of the neuropathic nerve to the applied magnetic stimulus, the first processing element for integrating the magnitude data and the orientation data from each of the sensing elements of the first unit, and for determining a first integrated magnitude and a first integrated orientation for the first unit; 
 a second processing engine for receiving raw reaction data from a second unit of sensing elements, the unit including a second set of at least three sensing elements and the raw reaction data including magnitude data and orientation data from each sensing element of the second unit and further characterizing the response of the neuropathic nerve, the second processing element for integrating the magnitude data and the orientation data from each of the sensing elements of the second unit, and for determining a second integrated magnitude and a second integrated orientation for the second unit; 
 a third processing engine for receiving the first and second integrated magnitude, determining which sensing unit evidences a greater magnitude, and associating a greater weight to the sensing unit evidencing the greater magnitude; 
 a fourth processing engine for receiving the first and second integrated orientation and associating a greater weight to whichever orientation is correlated with the unit evidencing the greater magnitude; 
 a fifth processing engine for receiving and evaluating respective integrated magnitude, integrated orientation, and weight data for a plurality of sensing units, and determining a set of coordinates defining the neuropathic nerve to be targeted in a treatment area based on evaluated magnitude, orientation, and weight data; and 
 a sixth processing engine for determining a first treatment protocol for administering the focused magnetic stimulation to the neuropathic nerve to be targeted so as thereby ameliorate neuropathic pain experience, the first treatment protocol including an orientation of a tMS application device relative to the neuropathic nerve to be treated in the target area and an amplitude of the focused magnetic stimulation to be administered. 
   
     
     
         16 . The system in accordance with  claim 15 , further comprising a transcutaneous magnetic stimulation (tMS) application device configured for delivering the focused magnetic stimulation to the neuropathic nerve to be targeted. 
     
     
         17 . The system in accordance with  claim 16 , further comprising a positioning element, the positioning element being coupled to the tMS application device and including a plurality of articulating arm members, a plurality of the arm members being coupled together by an automating element, the automating element for positioning and orienting the tMS application device proximate the treatment area in accordance with the orientation of the treatment protocol. 
     
     
         18 . The system in accordance with  claim 17 , wherein the tMS application device includes a controller configured for controlling the generation of the magnetic stimulation of the tMS application device with respect to one or more of the waveform to be produced and voltage and current employed in producing the waveform. 
     
     
         19 . The system in accordance with  claim 18 , wherein the transcutaneous sensing and monitoring device is further configured for sensing a response in the neuropathic nerve being targeted with magnetic stimulation to produce target nerve response data, and the computing device is configured for changing one or more of the orientation of the tMS application device or the amplitude of the waveform produced thereby based on the target nerve response data. 
     
     
         20 . The system in accordance with  claim 19 , wherein the system further comprises a movement sensor for detecting a movement of the target area, whereby any movement of the target area evokes a corresponding movement in the tMS application device so as to maintain its determined orientation to the target nerve.