Patent Publication Number: US-11642515-B2

Title: Sensing and stimulation system

Description:
This application is a Continuation of U.S. patent application Ser. No. 14/181,074, filed Feb. 14, 2014, entitled “SENSING AND STIMULATION SYSTEM”, the contents of which is incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     Conventional monitoring, diagnostic, and therapy equipment is typically structured in such a way that electrodes are mounted on the patient, which tap the respective signals and transmit such signals via cables to amplifier units. Such cables obstruct the patient and highly limit his or her freedom of movement. In addition, due to the stiffness of the cables and the forces connected therewith, the cables become easily detached particularly when the patient moves. Conventional therapy devices also typically provide stimulation to a broad area in a “shotgun” approach, rather than just providing stimulation to the specific areas in need. 
     SUMMARY 
     One embodiment is directed to a sensing and stimulation system. The system includes a central hub, and a plurality of flexible arms extending from the central hub. Each of the arms includes at least one electrode and at least one sensor. Each of the arms is configured to perform sensing and stimulation including electrically stimulating biological material, and sensing biological responses and changes. The system includes a port configured to be alternatively connected to a remote control module for wireless operation of the system and a leaded connector for wired operation of the system. 
     Another embodiment is directed to a sensing and stimulation system. The system includes a central hub, and a plurality of flexible arms extending from the central hub. Each of the arms includes at least one electrode and at least one sensor. Each of the arms is configured to perform sensing and stimulation including electrically stimulating biological material, and sensing biological responses and changes. The system includes a remote control module configured to control the sensing and stimulation, transmit and receive wireless signals, and receive sensor data from a prosthetic device and control the stimulation based on the received sensor data. 
     Yet another embodiment is directed to a method of providing sensing and stimulation for a body. The method includes providing a system including a central hub and a plurality of flexible arms extending from the central hub, wherein each of the arms includes at least one electrode and at least one sensor. The method includes adjusting a length of at least one of the arms, and attaching each of the arms, including the at least one arm with an adjusted length, to the body. The method includes performing sensing and stimulation with the attached arms, including electrically stimulating biological material, and sensing biological responses and changes. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a diagram illustrating a top view of a sensing and stimulation system according to one embodiment. 
         FIG.  2    is a diagram illustrating a close-up view of the distal end portion of one of the arms of the system shown in  FIG.  1    according to one embodiment. 
         FIG.  3    is a diagram illustrating a close-up view of a leaded connector of the system shown in  FIG.  1    according to one embodiment. 
         FIG.  4    is a diagram illustrating a perspective view of the system shown in  FIG.  1   , with arms of the system rolled up or folded up according to one embodiment. 
         FIG.  5    is a diagram illustrating a top view of the system shown in  FIG.  1   , with arms of the system rolled up or folded up according to one embodiment. 
         FIG.  6    is a diagram illustrating a top view of a sensing and stimulation system according to another embodiment. 
         FIG.  7    is a diagram illustrating a close-up view of the distal end portion of one of the arms of the system shown in  FIG.  6    according to one embodiment. 
         FIG.  8    is a diagram illustrating a close-up view of a leaded connector of the system shown in  FIG.  6    according to one embodiment. 
         FIG.  9    is a block diagram illustrating components of the remote control module shown in  FIGS.  1  and  6    according to one embodiment. 
         FIG.  10    is a diagram illustrating a remote control module according to one embodiment. 
         FIG.  11    is a diagram illustrating example uses of the sensing and stimulation systems according to one embodiment. 
         FIG.  12    is a diagram illustrating example uses of the sensing and stimulation systems according to another embodiment. 
     
    
    
     DETAILED DESCRIPTION 
       FIG.  1    is a diagram illustrating a top view of a sensing and stimulation system  100  according to one embodiment. Sensing and stimulation system  100  includes eight flexible arms  102 ( 1 )- 102 ( 8 ) (collectively referred to as arms  102 ) extending radially outward from a central hub  104 . The arms  102  include a primary arm  102 ( 8 ) and seven secondary arms  102 ( 1 )- 102 ( 7 ). Each arm  102  includes a distal end portion  106 , a proximal end portion  108 , and a central portion  110  that extends between the end portions  106  and  108 . The proximal end portion  108  of each arm  102  is connected to the central hub  104 . In one embodiment, system  100  has an overall diameter of about 5 mm or less. 
     System  100  may be used in either a wireless (or leadless) configuration or a wired (or leaded) configuration. In the embodiment shown in  FIG.  1   , the system  100  is in a wireless configuration, and includes a remote control module  112  plugged into a port  103  in the distal end  106  of the primary arm  102 ( 8 ). The remote control module  112  is described in further detail below with reference to  FIGS.  9  and  10   . In the wired configuration, the remote control module  112  is not used, and the system  100  is directly connected to another device via a leaded connector  300  ( FIG.  3   ), which is plugged into port  103 . 
       FIG.  2    is a diagram illustrating a close-up view of the distal end portion  106  of one of the arms  102  of the system  100  shown in  FIG.  1    according to one embodiment. In one embodiment, the arms  102  of system  100  are all configured in substantially the same manner shown in  FIG.  2   . As shown in  FIG.  2   , the distal end portion  106  includes an arm portion  212  and an oval-shaped electrode portion  214 . The arm portion  212  has a smaller width than the electrode portion  214 , and extends to the central hub  104 . The electrode portion  214  extends distally from the arm portion  212 , and has a larger width than the arm portion  212 . The electrode portion  214  includes a conductor plate  208  and stitch points  210 . The conductor plate  208  has a rectangular shape in the illustrated embodiment, and is connected to a lead wire  206 . The stitch points  210  are positioned distal to the conductor plate  208 , and facilitate attachment (e.g., via stitching) of the arm  102  to a patient. 
     The arm portion  212  includes thermal sensor wire (e.g., thermally active material)  202 , insulator (e.g., a biocompatible polymer)  204 , and lead wire  206 . Thermal sensor wire  202  extends laterally across the arm portion  212  adjacent to the electrode portion  214 , and then extends longitudinally along the arm  102  to the central hub  104 . Lead wire  206  is attached to conductor plate  208  and extends longitudinally along the arm  102  to the central hub  104 . Insulator  204  encloses and electrically insulates thermal sensor wire  202  and lead wire  206  along the length of the arm  102 . In one embodiment, wire  202  also acts as a pressure sensor. In another embodiment, a separate pressure sensing element is positioned along the length of the arm  102 . 
       FIG.  3    is a diagram illustrating a close-up view of a leaded connector  300  of the system  100  shown in  FIG.  1    according to one embodiment. As mentioned above, in the wired configuration, the remote control module  112  is not used, and the system  100  is directly connected to another device via leaded connector  300 . Leaded connector  300  includes connector  302  and flexible lead  304 . Connector  302  is configured to be plugged into the port  103  at the distal end of the primary arm  102 ( 8 ). Flexible lead  304  includes wires  308  and insulator  306 , and is configured to be attached to another device. Insulator  306  surrounds and electrically insulates the wires  308  along the length of the flexible lead  304 . The wires  308  extend through the connector  302 , and are configured to be electrically coupled to electrical connections of the system  100 . 
       FIG.  4    is a diagram illustrating a perspective view of the system  100  shown in  FIG.  1   , with arms of the system  100  rolled up or folded up according to one embodiment. As shown in  FIG.  4   , the arm portion  212  of arm  102 ( 1 ) has been rolled up, which effectively shortens the length of arm  102 ( 1 ) and causes the electrode portion  214  of arm  102 ( 1 ) to be positioned closer to the central hub  104 . The arm portion  212  of arm  102 ( 3 ) has been folded up in an accordion-like manner, which shortens the length of arm  102 ( 3 ) and causes the electrode portion  214  of arm  102 ( 3 ) to be positioned closer to the central hub  104 . Arm  102 ( 6 ) has been folded such that the electrode portion  214  is positioned directly under the central hub  104 . Arms  102 ( 1 ),  102 ( 3 ), and  102 ( 6 ) may be extended out to any desired length (up to a fully extended state) during deployment. The length of each arm  102  is adjustable, and manipulating the arms  102  of the system  100  as shown in  FIG.  4    facilitates an easier and more accurate deployment of the system  100 . 
       FIG.  5    is a diagram illustrating a top view of the system  100  shown in  FIG.  1   , with arms of the system  100  rolled up or folded up according to one embodiment. As shown in  FIG.  5   , the arm portions  212  of arms  102 ( 1 ) and  102 ( 5 ) have been completely rolled up or folded up, which effectively shortens the lengths of these arms and causes the electrode portions  214  of these arms  102  to be positioned directly adjacent to the central hub  104 . The arm portion  212  of arm  102 ( 3 ) has been partially rolled up or folded up, which effectively shortens the length of this arm and causes the electrode portion  214  of this arm  102 ( 3 ) to be positioned closer to the central hub  104  than the electrode portions  214  of arms  102 ( 2 ),  102 ( 4 ),  102 ( 6 ),  102 ( 7 ), and  102 ( 8 ), which are completely extended. Manipulating the arms  102  of the system  100  as shown in  FIG.  5    facilitates an easier and more accurate deployment of the system  100 . 
       FIG.  6    is a diagram illustrating a top view of a sensing and stimulation system  600  according to another embodiment. Sensing and stimulation system  600  includes eight flexible arms  602 ( 1 )- 602 ( 8 ) (collectively referred to as arms  602 ) extending radially outward from a central hub  604 . Each arm  602  includes a distal end portion  606 , a proximal end portion  608 , and a central portion  610  that extends between the end portions  606  and  608 . The proximal end portions  608  of the arms  602  are connected together at the central hub  604 . In one embodiment, system  600  has an overall diameter of about 5 mm or less. 
     System  100  ( FIG.  1   ) according to one embodiment has a star configuration in which the arms  102  extend radially outward from the central hub  104  at eight evenly spaced positions 360 degrees around the central hub  104 . In contrast, system  600  ( FIG.  6   ) according to one embodiment has a half-star configuration in which the arms  602  extend radially outward from the central hub  604  at eight evenly spaced positions 180 degrees around the central hub  604 . 
     System  600  may be used in either a wireless (or leadless) configuration or a wired (or leaded) configuration. In the embodiment shown in  FIG.  6   , the system  600  is in a wireless configuration, and includes a remote control module  112  plugged into a port  603  at the central hub  604 . The remote control module  112  is described in further detail below with reference to  FIGS.  9  and  10   . In the wired configuration, the remote control module  112  is not used, and the system  600  is directly connected to another device via a leaded connector  800  ( FIG.  8   ), which is plugged into port  603 . 
       FIG.  7    is a diagram illustrating a close-up view of the distal end portion  606  of one of the arms  602  of the system  600  shown in  FIG.  6    according to one embodiment. In one embodiment, the arms  602  of system  600  are all configured in substantially the same manner shown in  FIG.  7   . As shown in  FIG.  7   , the distal end portion  606  includes an arm portion  712  and an electrode portion  714 . The arm portion  712  has the same width as the electrode portion  714 , and extends to the central hub  604 . The electrode portion  714  extends distally from the arm portion  712 . The electrode portion  714  includes a conductor  708  and stitch point  710 . The conductor  708  is connected to a lead wire  706 . The stitch point  710  is positioned distal to the conductor  708 , and facilitates attachment (e.g., via stitching) of the arm  602  to a patient. 
     The arm portion  712  includes thermal sensor wire (e.g., thermally active material)  702 , insulator (e.g., a biocompatible polymer)  704 , and lead wire  706 . Thermal sensor wire  702  extends laterally across the arm portion  712  adjacent to the electrode portion  714 , and then extends longitudinally along the arm  602  to the central hub  604 . Lead wire  706  is attached to conductor  708  and extends longitudinally along the arm  602  to the central hub  604 . Insulator  704  encloses and electrically insulates thermal sensor wire  702  and lead wire  706  along the length of the arm  602 . In one embodiment, wire  702  also acts as a pressure sensor. In another embodiment, a separate pressure sensing element is positioned along the length of the arm  602 . 
       FIG.  8    is a diagram illustrating a close-up view of a leaded connector  800  of the system  600  shown in  FIG.  6    according to one embodiment. As mentioned above, in the wired configuration, the remote control module  112  is not used, and the system  600  is directly connected to another device via leaded connector  800 . Leaded connector  800  includes connector  802  and flexible lead  804 . Connector  802  is configured to be plugged into the port  603  at the hub  604 . Flexible lead  804  includes wires  808  and insulator  806 , and is configured to be attached to another device. Insulator  806  surrounds and electrically insulates the wires  808  along the length of the flexible lead  804 . The wires  808  extend through the connector  802 , and are configured to be electrically coupled to electrical connections of the system  600 . 
       FIG.  9    is a block diagram illustrating components of the remote control module  112  shown in  FIGS.  1  and  6    according to one embodiment. Remote control module  112  includes antenna  904 , receiver demodulator  906 , transmission modulator  908 , device security module  910 , radio frequency (RF) rectifier  912 , oscillator  914 , timing circuit  916 , battery manager  918 , capacitor manager  920 , processor memory  922 , processing logic (processor)  924 , sensor logic  926 , and sensor memory  928 . These elements are communicatively coupled together via communications and power bus  905 . 
     Antenna  904  is used by module  112  to send and receive RF energy (e.g., RF signals)  902 . Receiver demodulator  906  demodulates received RF signals and detects commands. Receiver demodulator  906  also extracts the clock from the received RF signals, which is used to synchronize the RF transponder with the RF transceiver. Transmission modulator  908  modulates received data (e.g., transponder ID and sensor data) for transmission to an RF transceiver. Device security module  910  ensures transponder to transceiver filtering (dense reader mode), restricts/controls transponder access, and regulates signal/ambient RF energy. RF rectifier  912  rectifies the input RF signal and manages/generates a DC voltage to power the other blocks of the module  112 . In one embodiment, the total power consumption of module  112  is 1 μW or less. 
     Oscillator  914  according to one embodiment is a switching/intermittent oscillator module that is used to convert an internal voltage into a pulsed signal. Timing circuit  916  comprises an internal clock that supplies an internally generated timing signal to digital elements of the RF transponder, which control the use of multiple timers as would be used to establish therapy delivery/stimulation and sensing rates. Additionally, the timing circuit  916  enables dynamic configuration of stimulation/sensing rates, hibernation states, data collection frequency sample rates, and transmission wake-up/duration. Battery manager  918  provides primary circuit power, current regulation, battery temperature monitoring, and power status. Module  112  includes a rechargeable battery  1006  ( FIG.  10   ) that stores excess rectified RF energy such as transceiver and ambient energy. Battery manager  918  is used to extend battery life of battery  1006 . Capacitor manager  920  regulates an adjustable capacitor  1004  ( FIG.  10   ) and works in conjunction with the oscillator module  914  to control pulse modulation, width/duration, frequency, and intensity. 
     Processor memory  922  stores data for processing logic  924 . Processing logic  924  is a digital part (e.g., microcontroller) of the module  112 , and controls all other blocks of the module  112 . Additionally, processing logic  924  stores the transponder ID, processes device instructions, determines when to collect data and when to transmit data, and when to hibernate. Sensor logic  926  controls electrical and thermal sensing, including sensor sample timing, results collection, and storage of sensor results data in sensory memory  928 . 
     To limit possible interference with other electrical devices, the RF transponder according to one embodiment communicates via inductive coupling using the high frequency (HF) of 13.56 MHz. The RF transponder frequency of 13.56 MHz complies with standards classified worldwide as ISM (industrial, scientific, medical) frequency ranges for use in ISM environments or by short range devices (SRD) frequency. 
       FIG.  10    is a diagram illustrating a remote control module  112  according to one embodiment. In addition to the elements shown in  FIG.  9   , including logic elements  922  and  926  and antenna  904 , module  112  also includes capacitor  1004  and battery  1006 . In one embodiment, capacitor  1004  is a 1 μW (or less) capacitor, and battery  1006  is a 200 uAhr rechargeable battery. Antenna  904  according to one embodiment is a compressed, fractal antenna 
       FIG.  11    is a diagram illustrating example uses of the sensing and stimulation systems  100  and  600  according to one embodiment. As shown in  FIG.  11   , multiple systems  100  and  600  have been applied to a patient  1102 . Specifically, system  100 ( 1 ), which is in a wireless configuration with an included remote control module  112 , has been applied to the chest of the patient via an epidermis patch  1103 . System  600 ( 1 ), which is in a wireless configuration with an included remote control module  112 , has been applied at a subdermal level at the patient&#39;s abdomen. System  600 ( 2 ), which is in a wireless configuration with an included remote control module  112 , has been applied at a subdermal level at the patient&#39;s forearm. Systems  100 ( 3 ),  100 ( 4 ),  100 ( 5 ), and  100 ( 6 ), which are each in a wireless configuration with an included remote control module  112 , are implanted on nerve bundles  1114  below the patient&#39;s knee. As shown in  FIG.  11   , the nerve bundles  1114  include neurons  1116 . 
     The patient  1102  is wearing a belt  1104 , which includes a rechargeable power source  1106 , and an RF transceiver  1108  that is configured to communicate with systems  100  and  600 . The patient  1102  is also wearing a wrist band  1110 , which includes an RF transceiver  1112  that is configured to communicate with systems  100  and  600 . 
     Prosthesis  1118  is configured to be attached to the leg of the patient  1102 . Prosthesis  1118  includes a rechargeable power source  1122 , and RF transceivers  1120  that are configured to communicate with systems  100  and  600 . Prosthesis  1118  also includes pressure sensors  1124  and proximity sensors  1126 . Sensors  1124  and  1126  generate sensor data that is transmitted to systems  100 ( 2 ),  100 ( 3 ),  100 ( 4 ), and  100 ( 5 ) via transceivers  1120 . Systems  100 ( 2 ),  100 ( 3 ),  100 ( 4 ), and  100 ( 5 ) use this received sensor data to generate appropriate stimulation signals. 
     The systems  100  and  600  shown in  FIG.  11    may be used to provide the user with direct and/or remote sensing responses, such as pressure, pain (neurological), cardiopulmonary, temperature, gastroenterology, skeletal, etc. Usage of systems  100  and  600  may include the collection and transfer of non-biological stimulation to the user/target such as provided from a gaming console, robot, prosthetic, wristband, patch, or other non-biological entities. Nodal relationships between remote controlled systems  100  and  600  are via a secure protocol with a unique identification for each system  100  or  600 . 
       FIG.  12    is a diagram illustrating example uses of the sensing and stimulation systems  100  and  600  according to another embodiment. As shown in  FIG.  12   , multiple systems  100  and  600  have been applied to a patient  1202 . Specifically, system  100 ( 6 ), which is in a wireless configuration with an included remote control module  112 , has been implanted and applied to the patient&#39;s heart. System  600 ( 3 ), which is in a wireless configuration with an included remote control module  112 , has been implanted and applied to the patient&#39;s stomach. System  600 ( 4 ), which is in a wireless configuration with an included remote control module  112 , has been implanted and applied to the patient&#39;s femur. System  100 ( 7 ), which is in a wired configuration with an included leaded connector  300 ( 7 ), has been implanted on nerve bundles  1204  on the patient&#39;s leg. As shown in  FIG.  12   , the nerve bundles  1204  include neurons  1206 . The connector  300 ( 7 ) is connected to device  1208 , which is a stimulation device in one embodiment. Device  1208  according to one embodiment is configured to communicate with system  100 ( 7 ) via the leaded connector  300 ( 7 ), and is configured to wireless communicate with systems  100 ( 6 ),  600 ( 3 ), and  600 ( 4 ). 
     The systems  100  and  600  shown in  FIG.  12    may be used to provide the user with direct and/or remote stimulation and sensing responses, such as pressure, pain (neurological), cardiopulmonary, temperature, gastroenterology, skeletal, etc. Nodal relationships between remote controlled systems  100  and  600  and direct connect systems  100  and  600  is via a secure protocol with a unique identification for each system  100  or  600 . 
     System  100  ( FIG.  1   ) and system  600  ( FIG.  6   ) according to one embodiment are multi-armed implantable (or externally attached) devices configured to electrically stimulate biological material, and sense biological responses and changes (e.g., nerves, tissue, muscles, skeletal, and fluids), within the body&#39;s electrical system, including changes in the temperature of surrounding tissue and pressure changes associated with movement or increased tension. The systems  100  and  600  can be configured to perform substantially similar functions, and are also referred to herein as system  100 / 600 . The system  100 / 600  according to one embodiment is referred to as a spider sensing and stimulation system (S4) specifically because of its use of multiple arms such as may be visually similar to a spider. 
     At the end of each arm  102 / 602  in the electrode portion  214 / 714 , electrical signals are sent to, or received from, biological regions based on programmable requirements/parameters (e.g., electrical sensing/stimulation of pulse modulate, width/duration, frequency, and intensity), while along the length or axis of each arm  102 / 602 , the system  100 / 600  detects and transmits any thermal variations of surrounding tissue as well as pressure changes. Though the number of arms  102 / 602 , length of the arms  102 / 602 , and size of system  100 / 600  may vary based on need, the system  100 / 600  according to one embodiment creates stimulation/sensing from each arm  102 / 602 , between two opposing arms  102 / 602 , between multiple implementations of the system  100 / 600  (e.g., connected in a nodal configuration), and/or between implementations of system  100 / 600  and sensor/stimulator devices (e.g., implanted using leads or external using telemetry [e.g., wireless communications]). 
     The system  100 / 600  according to one embodiment provides patients and medical professionals with programmable stimulation therapy and sensing (e.g., pain sensing, pulse modulation, width/duration, frequency, intensity, and temperature and pressure sensing) through the use of a compact multi-purpose device  100 / 600  that is able to be deployed both as an implant and external to the patient. Data collection is through interrogation, analysis, and system  100 / 600  has the ability to “learn” based on sensing history. 
     The biocompatible configurable system  100 / 600  is able to function as a single stimulation point (specific polarity) or in changing patterns, which rotate in various directions, intensity, and polarity, or in a nodal relationships between remote controlled implementations of system  100 / 600  (which includes mixed configurations [e.g., leaded configurations and leadless or remote control module configurations]). 
     Additionally, the system  100 / 600  is configured to store specific secure patient baseline data, such as base core body temperature (for different times of the day and events), normal pain thresholds, glucose alert thresholds/normal range, acceptable pressure variants, normal cardiac rhythms, gastro responses, limit values, and health specific data used to determine if an abnormal event has occurred, as well as when and how to react to a specific event (e.g., alert/notification, automatic response therapy [e.g., such as pain control]). 
     System  100 / 600  may be used for Neuro, Cardiac, Gastro, Ortho, Diabetes, etc. System  100 / 600  can be utilized for a variety of methods, including the following: (1) Method for sensing and controlling pain and neurological responses at a point of need; (2) method for providing muscular stimulation (such as with newly grafted muscles); (3) method for transmitting electrical signals between two points where there are barriers to electrical transmission (e.g., from amputation, nerve damage) or where a connection is needed between an external device (such as a prosthetic) and the patient&#39;s internal electrical system; (4) method for determining current temperature, abnormal temperature variations of surrounding tissue, and core body temperature; (5) method for sensing cardiac rhythms/signals and stimulating cardiac fluids and tissue; (6) method for sensing gastro signals and stimulating gastro organs, fluids, and tissue; (7) method for sensing orthopedic signals and stimulating bones in addition to associated components (e.g., bone morphogenetic protein [BMP]); (8) method of providing the user (signal receiver) with remote sensing responses (such as pressure, pain, temperature, etc.); (9) method for determining non-cardiac/non-neurological electrical signals within any biological environment; (10) method for detecting neuroglycopenia (severe neurological hypoglycemia) associated with diabetes and impaired brain function; and (11) method for detecting pressure changes in muscular structures (extension/contraction) and skeletal structures (growth/fusing) as well as changes in gastro organs as a means to determine movement and associated indicators of health. 
     Note that usage of system  100 / 600  may include the collection and transfer of non-biological stimulation to/from the user/target such as provided from a gaming console, robot, prosthetic, or other non-biological entities. In one embodiment, system  100 / 600  comprises a modified transcutaneous electrical nerve stimulation (TENS) unit to provide stimulation between two attachments points of opposing polarity. 
     In one embodiment, system  100 / 600  senses and relays variances detected in the neurological system (e.g., impedance, reaction frequency, and spikes [from normal baseline]), using a suitable conductive material (e.g., within biocompatible polymer(s)). Sensing by system  100 / 600  may also be used during surgeries (e.g., Spinal, Cardiac, Neuro, Ortho, Diabetes, etc.) as a method for determining patient response (for example, when a medical instrument moves from/through one area to another of divergent density/resistance [e.g., tissue, bone, muscle] alerting the physician of the transition). Additionally, system  100 / 600  is able to relay a patient&#39;s subtle biological reactions/responses (e.g., pain guarding response(s)) where the patient may be sedated and unable to respond appropriately. With the ability to detect neurological changes (within both the central nervous system [CNS] and the peripheral nervous system [PNS] [sensory nerves and motor nerves (somatic/autonomic nerves)]), the system  100 / 600  also possesses the ability to provide an automatic response to those changes (+/−) such as adjusting pain therapy that might be normally made available via an implanted neurostimulator. A system  100 / 600  deployed to provide peripheral nerve field stimulation (PNFS) is very similar to direct spinal cord stimulation (CNS), but instead involves placing the arms of the system  100 / 600  just under the skin (subdermal) in an area near to the target nerves (such as those involved in pain). 
     Use of system  100 / 600  is not limited to neurological, cardiopulmonary, orthopedic, gastroenterology, obesity, or diabetes usage models and may be also used to sense any thermal variations, pressure changes, and electrical signals that are produced within a biological environment (such as within the anatomy of a human or nonhuman patient), where the system  100 / 600  may be placed internal (e.g., epidermis level) and external. By including the ability to sense temperature changes (e.g., using thermally reactive material) in the patient, the system  100 / 600  may be used for early detection and notification of an infection, circulatory concern, and other health related issues. Additionally, the system  100 / 600  may be used to monitor changes in core body temperature, which can be an indicator of numerous health states. With the average normal body temperature being that of 98.2° Fahrenheit and a temperature over 100.4° Fahrenheit generally being an indicator of infection or illness, monitoring those changes in a patient&#39;s temperature with system  100 / 600  will assist with applying appropriate therapy/treatment by system  100 / 600 . It should also be noted that since a patient&#39;s fever threshold baseline varies during the day, a proper calibration of the system  100 / 600  is provided to account for a patient&#39;s specific temperature variations such that the best results will be used in alerting of an abnormal event/condition. Additionally, with the ability of system  100 / 600  to detect pressure changes (relative to each arm  102 / 602 ), the system  100 / 600  is able to determine movement associated variations within the target patient&#39;s muscular and skeletal structure (from baseline parameters). 
     Additionally, the system  100 / 600  can serve as a system to detect severe episodes of hypoglycemia through neurological sensing of neuroglycopenia (a potentially fatal event when low glucose reduces brain function such that a patient is no longer able to respond). The system  100 / 600  can also be used independently or as a backup to other glucose monitoring/control systems in the prevention of severe hypoglycemia, as well as integrated with insulin delivery therapies as part of a “closed loop” diabetes monitoring and control system. When deployed on the surface of the stomach or other gastrointestinal areas, the pressure/motion detection features of the system  100 / 600  can be used in the monitoring and treatment of obesity (e.g., through gastric expansion sensing and feedback, detection and recordation of the onset of food intake or detection of certain gastric related sounds) or other gastric disorders such as gastroparesis. 
     Placement of the system  100 / 600  may vary from placement as a patch on the patient&#39;s epidermis, within a wearable bracelet/ring/clothing/patch, subcutaneous insertion (subdermal) such as performed during an out-patient procedure, to placement deep within the patient&#39;s body (percutaneous or disambiguation) as performed during surgical procedures where the patient is placed under general anesthesia. Placement of the system  100 / 600  may be through known implant methods such as used in the practice of neurological, cardiopulmonary, orthopedic, diabetes, or gastroenterology lead placement. Additional methods for deployment may be procedurally such that an arm  102 / 602  of system  100 / 600  is inserted, stimulation pad attached, insertion tool retracted, next arm  102 / 602  is inserted, attached, tool retracted (and so on) until all arms  102 / 602  of the system  100 / 600  have been deployed. Once all arms  102 / 602  of the system  100 / 600  are deployed, then the remote control module  112  (in a wireless configuration) or the leaded connector  300 / 800  may be joined with the wires of the arms  102 / 602 , such that the remote control module  112  or leaded connector  300 / 800  cuts excess wire, electrically isolates each lead and arm wire, seals the module  112  or connector  300 / 800  to the arm wires, locks the system using both interlocking pin and socket or crimping/medical adhesive, and then creates an electrical link to the remote control module  112  circuitry or primary stimulation device I/O. 
     In one embodiment, each arm  102 / 602  of system  100 / 600  can be connected to the target area without the need to use methods that may themselves cause additional patient issues. Stich points  210 / 710  or micro hooks can be used on the end of each arm  102 / 602 , or a more passive method of adhesion or anchoring can be used. 
     An implanted system  100 / 600  is able to provide direct therapy to targeted areas of the patient. The system  100 / 600  allows for multiple methods of control and transmission of electrical signals (e.g., wired, wireless [e.g., radio frequency (RF)], and/or both). The wired method of control of system  100 / 600  according to one embodiment is via a leaded connector  300 / 800  attached to an implanted medical device capable of controlling multiple implementations of system  100 / 600 . The wireless remote control method of control of system  100 / 600  is via an individually attached rechargeable/inductively charged remote control module  112 . The attached remote control module  112  contains encapsulated circuitry that can be programmed remotely, perform preprogrammed functions, and be recharged inductively (using for example RF energy). 
     Embodiments of system  100 / 600  with the wireless control module  112  work independent or in a nodal relationship. In one embodiment, the nodal relationships between remote controlled systems  100 / 600  (or mixed configurations of systems  100 / 600  [leaded and leadless]) are via a secure protocol with unique identification for each system  100 / 600 . 
     System  100 / 600  may be adhered to a patient/user using stiches, micro hooks, or anchors to secure arm contact points, or a medical adhesive as a less intrusive method, without complicating or adding to potential/existing health issues. System  100 / 600  can be deployed as a purely inductively powered device (passive), inductively charged device (semi-passive), and as an internally powered rechargeable device (active) that combine the use of batteries and capacitors. In one embodiment, system  100 / 600  is a multi-mode device that is configured to automatically switch between a passive mode, a semi-passive mode, and an active mode. 
     Four methods for deploying system  100 / 600  and electrically connecting the remote control module  112  or leaded connector  300 / 800  will now be described. The first deployment method involves the following steps: (1) Insert the system  100 / 600  with arms  102 / 602  retracted (see, e.g.,  FIGS.  4  and  5    and corresponding description) until the system  100 / 600  reaches the center point of the target; (2) extend deployment tool to a target location; (3) connect a single arm  102 / 602  to target location; (4) retract deployment tool to center point; (5) for each arm  102 / 602 , repeat the process of extending to a target location, attaching arm  102 / 602  to target location, and retracting the deployment tool to the center point; (6) connect the remote control module  112  or the leaded connector  300 / 800  by pushing the module  112  or connector  300 / 800  into the system  100 / 600 , and locking the module  112  or connector  300 / 800  in position using a crimping method combined with the use of a medical adhesive; and (7) activate the system  100 / 600  using an external user/physician wireless control module and/or an implanted stimulation/sensing device. 
     The second deployment method involves the following steps: (1) Use a catheter insertion tool to insert an arm  102 / 602  to the target location (where therapy will be delivered); (2) attach the arm  102 / 602 ; (3) retract the catheter insertion tool, leaving the arm  102 / 602  in place; (3) for each arm  102 / 602 , repeat the insert, attach, and retract steps until all of the arms  102 / 602  are in place; (5) join either the remote control module  112  or leaded connector  300 / 800  to the system  100 / 600  such that the joining includes cutting the excessive arm wire; electrically connecting the module  112  or connector  300 / 800  to the arm wires; sealing the connection point physically (such as might be used with a pin and socket); and sealing the connection point with medical adhesive; and (6) activate the system  100 / 600  using an external user/physician wireless control module and/or an implanted stimulation/sensing device. 
     The third deployment method involves the following steps: (1) embed the system  100 / 600  with a connected remote control module  112  within an adhesive patch/bandage and apply over a target sensing/stimulation site (e.g., heart, nerve group, feet, wrist, shoulder, etc.); and (2) activate the system  100 / 600  with an external user/physician wireless control module. 
     The fourth deployment method involves the following steps: (1) deploy the system  100 / 600  with a connected remote control module  112  as described by either the first or second deployment methods described above; (2) activate the system  100 / 600  with an external user/physician wireless control module; and (3) provide continuous charge, communications, data storage, and updated programming through a wearable rechargeable transceiver device such as a wristband, belt, anklet or device interwoven into the patient clothing. External collection/control devices are configured with enough internal memory and power to allow for usage outside of any interfacing “Target Area”. 
     Usage models for system  100 / 600  include, but are not limited to, employing multiple systems  100 / 600  in multiple configurations in a wireless mesh network, where network nodes and associated devices are integrated into the environment of the defined space (see “Target Areas” below) and where the wireless mesh network is able to provide continuous telemetry (may include inductive charging)/control/communications with the system(s)  100 / 600 . 
     Users of system  100 / 600  may have the ability to collect health related data such that the data can be used to provide improved health monitoring, response, and notification to patients/clients and secure health systems. Collected data may be (as configured by the user) transmitted to medical professionals/systems (e.g., clinic, ER, hospital, primary care physician, dentist, pharmacist, wellness system, etc.). Data collected by the system  100 / 600  will be used to assist with “learning” and optimizing the internal sensing algorithms, response/therapy, and notifications and behaviors of system  100 / 600 . In addition to system  100 / 600  providing real-time sensing and stimulation, collected data from system  100 / 600  can be used by predictive (statistical) systems such as would help provide a pre-diagnosis of a negative medical/health condition. With respect to notification systems, a user of system  100 / 600  might be informed of serious health risks (e.g., cardiopulmonary, neurological, gastroenterology, orthopedic, respiratory, diabetes, cancer, etc.) and also be notified of less critical issues associated with diet, dehydration, temperature, or potential signs of, for example, a common cold. 
     The following is a description of some target areas for use of system  100 / 600 . A first target area is a home. A home environment would most likely combine all elements found within all other target areas, with the addition of data that might be collected from the home air conditioning system (e.g., air quality, humidity, temperature), bath, shower, sink, toilet, security system (e.g., motion detectors measuring user activity), refrigerator/freezer/pantry/cabinets (tracking food/dietary intake, medicine), TV/gaming system (IR/motion sensing), audio system, water softener, etc. User notification could be through home entertainment systems, device displays (as shown for example on a fridge display panel). Example areas within this target area include, for example, the following: kitchen, bedroom, living room, dining room, family room, garden, home office, and bathroom. 
     A second target area is medical facilities/physical therapy clinics/primary care physician offices/dentist offices/pharmacy. Medical facilities deploying systems that are able to interface with system  100 / 600 , may incorporate all means of collecting (interfacing) and controlling data as discussed herein. With the potential added benefit of patient tracking, users of system  100 / 600  may interface with systems such as those shown in U.S. Published Patent Applications Nos. 2011-0307284 and 2011-0307274, which are hereby incorporated by reference herein. This can help optimize work flow management, ensuring the timely application of medical therapy and the coordination of medical resources. Example areas in this target area include, for example, the following: waiting room, admitting area, diagnosis areas (e.g., X-Ray, MRI, Ultrasound, etc.), recovery room, surgical room, examination room, bathrooms, patient (overnight) rooms, and prescription pickup. 
     A third target area is work. Office environments can be used to monitor normal health indicators as well as data that might indicate elevated stress, the need to take a break/stretch, take prescribed medicine, drink water, etc. Though it may not be feasible to configure/calibrate a work environment&#39;s entire wireless mesh network to suit each individual, much of the same data collected within a home environment would also be desired in a work environment. Example areas in this target area include, for example, the following: desk environment, conference room(s), workout area, parking lot, and cafeteria/break room. 
     A fourth target area is school. For pediatric applications in particular, the school environment has similarities to the home and work environments along with some elements of a primary care environment in the form of a student health office and a paraprofessional health practitioner who assists with care. Many of the same environmental factors could participate in the sensing system, along with predictable schedules (such as physical education, recess, and other high activity events) and known nutrition information from school lunch programs to optimize sensing and therapy. Alerts could go to students, teachers, teaching assistants, the student health office, and other individuals participating in a patient&#39;s secondary care. Example areas in this target area include, for example, the following: gymnasium, cafeteria, health office, and classroom. 
     A fifth target area is gym/sports complex. Facility equipment/systems linked to fitness routines/workout programs, class schedules, etc. are additional examples of environments for use with embodiments disclosed herein. Users of system  100 / 600  may track normal biological responses such as calories burned, cardiac rhythms, respiratory response (along with any abnormal conditions) while assisting the user with achieving improved health (e.g., muscle and bone strength, oxygen absorption, improved metabolism). Example areas in this target area include, for example, the following: Fitness room, pool, spinning room, yoga area, and spa. 
     A sixth target area is car/bus/van pool. A road vehicle environment may also collect data from the vehicle air conditioning system, audio system, as well as an internalized wireless mesh network. User notification could be through the vehicle entertainment system and the primary in-dash display. 
     A seventh target area is airport/airplane/jet. In addition to data collected from system  100 / 600  via the internalized wireless mesh network, the monitoring of a flying vehicle&#39;s air quality, temperature, cabin pressure, etc. could be very valuable in determining patient risks (such as dehydration, thickening of the blood, circulatory issues, viral risks, etc.). 
     An eighth target area is a grocery store. An interactive environment would use an individual&#39;s unique data (such as an online grocery list) combined with in-store data as provided during the process of shopping or at checkout. User notification (related to user needs, interactions with other items, healthy choices, etc.) could be through a mobile phone (or other mobile device) and/or via a grocery cart with an integrated user interface. Data collected from the grocery store (specific to the individual) would be transmitted to the user&#39;s personal data repository where it would be used in conjunction with all other user collected data to assist the user in maintaining a healthy life style/environment. 
     There should be no assumed limitations of where system  100 / 600  could be used or any environment where monitoring/control/notification systems could be deployed (e.g., restaurants, grocery stores, libraries, schools, etc.). Though this disclosure mentions wireless mesh networks, the tools that could be used to interface to system  100 / 600  could be as simple as a mobile phone (remote access point), laptop, TV, etc. 
     To supplement the environment and to improve a user&#39;s interaction with interfaced in-home systems as well as with system  100 / 600 , a reader/scanner/antenna (1D, 2D, RFID) may be employed, which is able to identify and track items placed and pulled to/from a storage location. Another solution would be one device with an interface where the user could input data and select storage locations. Information stored in the home system could also be gathered from a grocery store system (see target areas above) and combined to form a more complete health/wellness picture. That information may relate to dietary information (contents), servings, expiration, storage requirements (cold, dry, warm, etc.), usage (paper towels, toiletries, cleaning supplies, etc.), safety (proximity to other items, not to be frozen, keep out of reach of children, too many consumed [e.g., aspirin or cold medicine], etc.), pharmacy items (might also link to a person&#39;s schedule for taking required medicine, or when a prescription might expire, drug reactions or how a particular drug should be taken [with food/liquid, before bed time, etc.], etc.). The home system would also be adaptive to provide for interfacing with items created in the home (e.g., liquids, meals, home grown, canned, etc.) where those items would be individually tagged (using a reusable tag [e.g., RFID]) such that the home systems could track those items (e.g., usage, expiration, user entered details, etc.). 
     One embodiment is directed to a sensing and stimulation system. The system includes a central hub, and a plurality of flexible arms extending from the central hub. Each of the arms includes at least one electrode and at least one sensor. Each of the arms is configured to perform sensing and stimulation including electrically stimulating biological material, and sensing biological responses and changes. The system includes a port configured to be alternatively connected to a remote control module for wireless operation of the system and a leaded connector for wired operation of the system. 
     In one embodiment, the system is configured to receive sensor data from a prosthetic device and generate stimulation signals based on the received sensor data. The remote control module according to one embodiment is configured to control the sensing and stimulation and transmit and receive RF signals. In one embodiment, an overall length of each of the arms is individually adjustable. The at least one sensor included in each arm is configured to detect thermal variations along substantially an entire length of the arm. In one embodiment, the at least one sensor is configured to detect pressure changes. 
     In one embodiment, the plurality of flexible arms includes at least eight flexible arms extending radially outward from a central hub, and wherein a proximal end of each of the arms is connected to the central hub. In one form of this embodiment, a distal end of one of the arms includes the port. In another embodiment, the central hub includes the port. In one embodiment, the at least eight flexible arms are arranged in a star configuration in which the arms extend radially outward from the central hub at evenly spaced positions 360 degrees around the central hub. In another embodiment, the at least eight flexible arms are arranged in a half-star configuration in which the arms extend radially outward from the central hub at evenly spaced positions 180 degrees around the central hub. 
     The system according to one embodiment is configured to automatically switch between a passive mode, a semi-passive mode, and an active mode, wherein the system is purely inductively powered in the passive mode, inductively charged in the semi-passive mode, and internally powered with a rechargeable battery in the active mode. In one embodiment, the system is configured to store health specific data used to determine if an abnormal event has occurred, and is configured to automatically react to the abnormal event with response therapy. 
     Another embodiment is directed to a sensing and stimulation system. The system includes a central hub, and a plurality of flexible arms extending from the central hub. Each of the arms includes at least one electrode and at least one sensor. Each of the arms is configured to perform sensing and stimulation including electrically stimulating biological material, and sensing biological responses and changes. The system includes a remote control module configured to control the sensing and stimulation, transmit and receive wireless signals, and receive sensor data from a prosthetic device and control the stimulation based on the received sensor data. 
     In one embodiment, an overall length of each of the arms is individually adjustable. The at least one sensor included in each arm according to one embodiment is configured to detect thermal variations along substantially an entire length of the arm. 
     In one embodiment, the plurality of flexible arms includes at least eight flexible arms extending radially outward from a central hub, and wherein a proximal end of each of the arms is connected to the central hub. In one form of this embodiment, the at least eight flexible arms are arranged in a star configuration in which the arms extend radially outward from the central hub at evenly spaced positions 360 degrees around the central hub. In another embodiment, the at least eight flexible arms are arranged in a half-star configuration in which the arms extend radially outward from the central hub at evenly spaced positions 180 degrees around the central hub. 
     Yet another embodiment is directed to a method of providing sensing and stimulation for a body. The method includes providing a system including a central hub and a plurality of flexible arms extending from the central hub, wherein each of the arms includes at least one electrode and at least one sensor. The method includes adjusting a length of at least one of the arms, and attaching each of the arms, including the at least one arm with an adjusted length, to the body. The method includes performing sensing and stimulation with the attached arms, including electrically stimulating biological material, and sensing biological responses and changes. 
     Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.