US20220266024A1 - Neurostimulation device with recording patch - Google Patents

Abstract

The present disclosure describes systems and methods for recording electrical activity, such as local field potentials. The system can include a recording patch that is placed inline between an implanted neurological lead and an implantable pulse stimulator. The recording patch can include recording and amplification circuitry that detects, records, and amplifies electrical activity (also referred to as signals) from a target site. The system can be used to select over which of the lead's electrodes therapeutic stimulations are delivered.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application claims benefit of priority under 35 U.S.C. § 120 as a continuation of U.S. patent application Ser. No. 16/424,044, titled “NEUROSTIMULATION DEVICE WITH RECORDING PATCH,” filed May 28, 2019, which is incorporated herein by reference in its entirety.
BACKGROUND OF THE DISCLOSURE
• Deep brain stimulation (DBS) is a neurostimulation therapy that can involve electrical stimulation systems that stimulate the human brain and body. DBS can be used to treat a number of neurological disorders. Typically, DBS involves electrically stimulating a target area of the brain.
SUMMARY OF THE DISCLOSURE
• The present disclosure describes systems and methods for recording electrical activity, such as local field potentials. The system can include a recording patch that is placed inline between an implanted neurological lead and an implantable pulse stimulator. The recording patch can include recording and amplification circuitry that detects, records, and amplifies electrical activity (also referred to as signals) from a target site. The system can be used to select over which of the lead's electrodes to deliver therapeutic stimulations. The system can select the electrodes based on the amount of power within the beta band of the signal or other characteristics of the signal.
• According to at least one aspect of the disclosure, an implantable device can include a first port. The first port can be configured to receive a connection from an implantable pulse stimulator. The first port can include a first plurality of connections. The device can include a second port. The second port can be configured to receive a connection from an implantable lead. The second port can include a second plurality of connections. The device can include a plurality of switches. The switches can be configured to selectively interconnect, at a first time point, the first plurality of connections with the second plurality of connections to pass a stimulation signal from the implantable pulse stimulator to the implantable lead. The switches can selectively interconnect, at a second time point, the second plurality of connections with a recording module. The recording module can generate an amplified biological signal based on a biological signal received from the second plurality of connections. The recording module can transmit the amplified biological signal to a receiver.
• According to at least one aspect of the disclosure, a method can include implanting a recording patch into a subject. The recording patch can include a first port that can be configured to receive a connection from an implantable pulse stimulator. The first port can include a first plurality of connections. The recording patch can include a second port that can be configured to receive a connection from an implantable lead that can include a plurality of electrodes. The second port can include a second plurality of connections. The recording patch can include a plurality of switches in electrical communication with the first plurality of connections and the second plurality of connections. The recording patch can include a recording module. The method can include coupling, with the plurality of switches, the second plurality of connections with the recording module. The method can include receiving, at the second plurality of connections, biological signals from the implantable lead. The method can include generating, by the recording module, amplified biological signals based on the biological signals. The method can include determining at least one signal characteristic of the biological signals. The method can include selecting an electrode of the plurality of electrodes based on the at least one signal characteristic of the biological signal.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings are not intended to be drawn to scale. Like reference numbers and designations in the various drawings indicate like elements. For purposes of clarity, not every component may be labelled in every drawing. In the drawings:
• FIG. 1 illustrates a front view of a subject implanted with an example system for performing neurostimulation.
• FIG. 2 illustrates a perspective view of the subject implanted with the example system for performing neurostimulation.
• FIG. 3 illustrates an enlarged view of the recording patch implanted below the subject's scalp.
• FIGS. 4-6 illustrate enlarged views of the recording patch illustrated inFIGS. 1-3.
• FIGS. 7A and 7B illustrate an example recording patch.
• FIG. 8 illustrates a block diagram of an example schematic of the system illustrated inFIGS. 1-3.
• FIGS. 9A and 9B illustrate block diagrams example methods to record biological signals with the system described herein.
• FIGS. 10-13 illustrate plots of the power spectral densities of signals recorded with the systems described herein.
• FIG. 14 illustrates an example heat map of the amount of beta activity recorded at each of the electrodes of the lead during a plurality of activities.
DETAILED DESCRIPTION
• The various concepts introduced above and discussed in greater detail below may be implemented in any of numerous ways, as the described concepts are not limited to any particular manner of implementation. Examples of specific implementations and applications are provided primarily for illustrative purposes.
• The present disclosure describes a technical solution for performing neural recordings and stimulations. The system can include a recording patch that can be coupled inline between an implanted pulse stimulator and a lead implanted into, for example, a subject's brain. The recording patch can receive biological signals from the subject's brain and can amplify the biological signals. The biological signals can be any electrophysiological signal generated by the patient, such as local field potentials, single units, neural ensembles, or other electrical signals generated by patient's brain or body. The recording patch transmit the amplified signals to an external device. The external device can also provide wireless power to the recording patch. The signals collected by the recording patch can be used to guide the subject's therapy. For example, the recording patch or external device associated with the recording patch can select stimulation electrodes based on power distributions within specific frequency bands of the amplified signals. When not in use, the recording patch can be placed into a pass-through mode that enables the stimulation signals from the pulse stimulator to pass substantially unchanged through the recording patch to the lead.
• FIG. 1 illustrates a front view of a subject implanted with anexample system50 for performing neurostimulation.FIG. 2 illustrates a perspective view of the subject implanted with theexample system50 for performing neurostimulation.FIG. 3 illustrates an enlarged view of therecording patch100 implanted below the subject'sscalp300.
• Thesystem50 includes arecording patch100 implanted below the subject's scalp. Therecording patch100 is coupled with animplantable pulse stimulator102, which is implanted into the subject104. Therecording patch100 is also coupled with animplantable lead106. Animplantable lead106 can be implanted into each hemisphere of the subject's brain (or other location within the subject). Therecording patch100 can be coupled with thepulse generator102 and theleads106 viacables108.
• Thesystem50 can include one ormore recording patches100. Therecording patches100 are described further in relation toFIGS. 3-9, among others. Therecording patch100 can improve (or provide) the recording capabilities for theimplantable pulse stimulator102. Thepulse stimulator102 can be a stimulation only device (e.g., thepulse stimulator102 may not include recording capabilities) and therecording patch100 can perform electrical recordings that are used to monitor the subject's response to electrical stimulations and coordinate the subject's therapy.
• Therecording patch100 can be placed inline between theimplantable pulse stimulator102 and theleads106. Theimplantable pulse stimulator102 can be configured to deliver electrical stimulation to the subject via the leads106.
• Therecording patch100 can amplify electrical signals (e.g., biological signals) detected by the electrodes of theleads106. Therecording patch100 can amplify the signals and transmit the amplified signals externally from the subject to, for example, an external programmer, which can also be referred to as a receiver. Therecording patch100 can calculate or determine one or more characteristics of the signals and transmit the characteristics of the signal externally from the subject. In some cases, therecording patch100 can transmit the amplified signals to an external programmer that can calculate the signal characteristics. The signal characteristics can include power distributions within specific frequency ranges of the amplified signals.
• The leads106 can record or detect local field potentials (LFPs). LFPs can be low frequency fluctuations of electrical activity below about 500 Hz. LFPs can represent the spatial-temporal summation of postsynaptic potentials from local neuronal ensembles in the vicinity of the electrode. The LFPs can be viewed as a metric of neuronal synchronization. In Parkinson's subjects, a suppression of beta activity by high-frequency stimulation of the subthalamic nucleus can lead to motor improvements.
• Therecording patch100 can select one or more of the lead's electrodes as stimulating electrodes. The selection of the stimulating electrodes can be based on the signals (or the characteristics thereof) detected or recorded at therecording patch100. For example, therecording patch100 can select the electrodes for stimulation that include the most power within the beta band.
• When therecording patch100 is not being used to actively record signals from the subject104, therecording patch100 can be placed into a stimulation mode (which can also be referred to as a pass-through mode) and can transmit or forward stimulation signals from theimplantable pulse stimulator102 to theleads106. In the pass-through mode, therecording patch100 does not substantially affect the stimulation signal generated by theimplantable pulse stimulator102 as the stimulation signal passes through therecording patch100. For example, the voltage and current of the stimulation signal can be substantially the same when entering and exiting therecording patch100.
• Theimplantable pulse stimulator102 can generate therapeutic, electrical stimulations that can be delivered to the subject's brain or other locations by leads106. Theimplantable pulse stimulator102 can be implanted into the subject104 at a surgical site remote to therecording patch100 and theleads106. For example, theimplantable pulse stimulator102 can be implanted into a surgically created pocket in the subject's chest, between the skin and muscle. Theimplantable pulse stimulator102 can generate stimulation signals that pass to the subject104 via thecables108,recording patch100, and lead106. The stimulation signal can include a plurality of wave forms including, but not limited to, pulses, charged balanced pulses, sinusoidal waves, square waves, triangle waves, and combinations thereof. The electrical stimulation can provide a therapeutic benefit to the subject, such as, suppressing beta activity.
• Theimplantable pulse stimulator102 can be a stimulating only device. For example, theimplantable pulse stimulator102 does not receive biological signals from the subject. Theimplantable pulse stimulator102 can be a stimulating and recording device. For example, theimplantable pulse stimulator102 can both generate and output stimulation signals and also receive biological signals that theimplantable pulse stimulator102 digitizes and stores.
• Thesystem50 can include a plurality ofcables108. One ormore cables108 can interconnect therecording patch100 and theimplantable pulse stimulator102 and therecording patch100 and theleads106. Eachcable108 can include a plurality of conductors to independently carry a plurality of signals between the components connected with thecable108. For example, thelead106 can have 12 electrodes and thecable108 can include a dedicated conductor for each of the different electrodes. For each conductor within thecable108, thecable108 can include a terminal or connector at each end of thecable108.
• Thesystem50 can include one or more leads106. Thesystem50 can include alead106 for eachrecording patch100. Thelead106 can be a multielectrode lead. Thelead106 can include a distal end and a proximal end. The distal end can include a plurality of electrodes. The proximal end can include a plurality of terminal contacts. Each of the terminal contacts can be electrically coupled with at least one of the electrodes. For example, a wire (or other electrical trace) can run through the interior of the lead106 from one of the terminal contacts to a contact disposed toward the distal end that is in electrical communication with the electrode. Thelead106 can be a MEMS-basedlead106. For example, thelead106 can include a MEMS film that includes a plurality of electrodes. The MEMS film can be manufactured as a planar film. The MEMS film can be heated and molded to form a cylinder. The cylinder can be backfilled with a polymer to electrically encapsulate the connections of thelead106 and fill the cylinder's lumen. Thelead106 can be a lead as described in U.S. Pat. No. 9,474,894, which is herein incorporated by reference in its entirety.
• FIGS. 4-6 illustrate enlarged views of therecording patch100. Therecording patch100 can include a plurality ofports400. Theports400 can include a plurality ofconnections402. Theports400 can includescrews412 to secure thecables108 into theports400. Therecording patch100 can include anantenna404 for receiving power from an external source and to transmit and receive data with an external source. Therecording patch100 can include acontroller406 to control data exchange and a plurality of switches that interconnect theports400 with a recording module. Thehousing408 of therecording patch100 can include a pass-throughport414 through which thelead106 passes. Thehousing408 can include ascrew410 that can be used to secure therecording patch100 to the subject's skull.
• Therecording patch100 can include a plurality ofports400. Therecording patch100 can include afirst port400 and asecond port400. One of theports400 can be configured to receive a connection from thepulse stimulator102. One of theports400 can be configured to receive a connection from thelead106.
• Theports400 can be male connections, female connections, or a combination thereof. For example, oneport400 can be a female connector and asecond port400 can be a male connector. Theports400 can each include a plurality ofconnections402. For example, for afemale port400, the plurality ofconnections402 can be distributed along the axial length of the port's internal lumen. For amale port400, theconnections402 can be distributed along the axial length of the port's barrel.
• Each of theconnections402 can be ring-based electrical contacts. At each axial position of theconnections402 along theport400, theconnections402 can include a metal layer around the circumference of the port's lumen. Theconnections402 can be springed or hinged pins that can depress onto a contact of thecable108 when thecable108 is inserted into theport400. Thecable108 can include a plurality of contacts along its tip. Each of the cable's contacts can align with one of theconnections402 when thecable108 is inserted into theport400. Each port can include between about 2 and about 64, between about 6 and about 64, between about 12 and about 64, or between about 8 and about 32connections402. Theconnections402 can include Platinum-Iridium, MP35N, or other medical implantable conductive metal.
• Theport400 can include a mechanism to secure thecable108 to therecording patch100. For example, eachport400 can include ascrew412. Thescrew412 can be a blunt tipped screw such that thescrew412 does not puncture thecable108. Once thecable108 is inserted into theport400, thescrew412 can be tightened onto thecable108 to secure thecable108 in place. The mechanism to secure thecable108 into place can include a lure-lock or other type of latching system.
• Therecording patch100 can include anantenna404. Theantenna404 can be a wire coil that is embedded within the body of thehousing408. Theantenna404 can be a plurality of electrical traces etched onto a circuit board to which the other components (e.g., thecontroller406 and power supply) are coupled.
• The diameter of theantenna404 can be selected to enable theantenna404 to efficiently couple with an external source, such as an external programmer, power source, or data storage device (each of these functions can be performed by a single, external device). Theantenna404 can enable therecording patch100 to wirelessly communicate with an external programmer over the 27 MHz frequency. Other frequencies which could be used are any of those determined by the International Telecommunication Union Radiocommunication Sector (ITU-R) in their reserved Industrial, Scientific, and Medical (ISM) Bands such as for example, but not limited to, 6.780 Mhz, 13.560 MHz, 40.680 MHz, 2.450 GHz, 5.80 GHz. The antenna diameter can be inversely proportional to the wavelength of the signal theantenna404 transmits over. For example, with a 27 MHz frequency the loop diameter of theantenna404 can be about 25 mm in diameter. In general, the loop diameter of the antenna is about half the wavelength of the frequency used to communicate with the antenna.
• Theantenna404 can be used to inductively receive power from an external power source. Therecording patch100 can have no internal power source. In this case the inductively coupled power from the external source can be used to power therecording patch100. The external power source can provide sufficient power to power therecording patch100 during recording operations. For example, therecording patch100 can inductively receive between about 5 mW and about 15 mW when in operation. Therecording patch100 can include an internal power source, such as a battery. Therecording patch100 can recharge the battery by inductively receiving power via theantenna404, which is stored in the battery.
• Theantenna404 can be used to transmit data between therecording patch100 and an external source. For example, therecording patch100 can receive electrical signals from thelead106. The electrical signals can be biological signals, such as electrical signals generated by the subject's brain. Therecording patch100 can amplify the received signals. Therecording patch100 can digitize the signals. Therecording patch100 can transmit the digitized signals to the external source via theantenna404. Theantenna404 can also receive configuration information from the external source. For example, via theantenna404, therecording patch100 can receive configuration information that puts therecording patch100 into a pass-through mode or a recording mode. The configuration information can include connection information. The connection information can include instructions for the interconnection of the first port'sconnections402 with the second port'sconnections402.
• Therecording patch100 can include acontroller406. Thecontroller406 is also described further in relation toFIG. 8, among others. Thecontroller406 can include one or more amplifies. For example, thecontroller406 can include an amplifier for each of the channels coming into therecording patch100 from thelead106. The amplifiers can be configured to amplify the signals before the signals are transmitted to an external source.
• Thecontroller406 can include different modules. For example, thecontroller406 can include a recording module that controls the recording and digitization of the signals coming into therecording patch100 from thelead106. Thecontroller406 can include a selector module. The selector module can determine which of the lead's electrodes should be used to deliver electrical stimulation to the subject. For example, based on a power distribution within the beta band, the selector module can select and configure which of the connections in theport400 going to thelead106 should be coupled with connections inport400 going to thepulse stimulator102.
• The selector module can select the electrodes to use for stimulation based on the signal characteristics of the signals received from thelead106. The characteristics can be the amount of power in a beta band of the received signals. The beta band can be between about 10 Hz and about 30 Hz, for example. The selector module can select the electrodes that include the most power in the beta band.
• The components of therecording patch100 can be enclosed within ahousing408. For example, thecontroller406 and theantenna404 can be contained within an internal space of thehousing408. Thehousing408 can be manufactured from plastic or be a hermetically sealed titanium case. Thehousing408 is molded around the components of therecording patch100. Thehousing408 can include one or more electrode sites to enable thehousing408 to be used as a ground or reference for the recordings made at thelead106. Thehousing408 can be metal and thehousing408 itself can be used as a ground or reference electrode. Thehousing408 can be implemented in Titanium, Titanium Dioxide, Ceramic, Polymer, or any material that conductive or capacitive, biocompatible, and maintains the inner contents sealed.
• Thehousing408 can include a convex shape that enables therecording patch100 to be secure against the subject's skull. The convex shape of therecording patch100 can substantially match the curvature of the subject's skull. Thehousing408 can be flexible to conform to the curvature of the subject's skull. Thehousing408 can be secured to the subject's skull with ascrew410.
• Thehousing408 can include a pass-throughport414. The pass-throughport414 can be configured to receive and hold thelead106 or body thereof. The pass-throughport414 can include alip416 that mates with the burr hole (in the subject's skull) through which thelead106 is implanted into the subject's brain. For example, thelip416 can extend between about 1 mm and about 5 mm below the portion of thehousing408 including the pass-throughport414. The outer diameter of thelip416 can be substantially the same or slightly less than the inner diameter of the burr hole such that thelip416 can be press fit into the bur hole by the implanting surgeon.
• The pass-throughport414 can be used to stabilize and secure thelead106. The pass-throughport414 can be used to seal the burr hole. For example, the pass-throughport414 can include a flexible material that includes a slit. Thelead106 can pass-through the slit in the flexible material, which can seal around thelead106. The sealed flexible material can prevent contaminants from entering the burr hole and can be implemented as an elastomer or polymer, such as a medical grade Silicone. Thehousing408 can also include a burr hole cap that can cover and seal the pass-throughport414.
• FIGS. 7A and 7B illustrate anexample recording patch100.FIG. 7A illustrates a top view of therecording patch100.FIG. 7B illustrates a perspective view of therecording patch100. Referring toFIGS. 7A and 7B together, therecording patch100 can include ahousing700 that is coupled with the subject's skull via ananchor702. Thehousing700 can include ports704(1)-704(3), which can be referred to asports704.
• The components of therecording patch100 can be enclosed within thehousing700. For example, thehousing700 can house acontroller406 and theantenna404 as described above in relation toFIG. 6, among others. Thehousing700 can be manufactured from plastic or be a hermetically sealed titanium case. Thehousing700 can be molded around the components of therecording patch100. Thehousing700 can include one or more electrode sites to enable thehousing700 to be used as a ground or reference for the recordings made at thelead106. Thehousing408 can be metal and thehousing408 itself can be used as a ground or reference electrode.
• Thehousing700 can be configured in a “radial” or “spoke and hub” configuration. In these configurations, thehousing700 can include a plurality ofspokes706 that radiate out from acentral hub708. Each of thespokes706 can terminate with or otherwise include at least oneport704. Thehousing700 can include between about 2 and about 10, between about 2 and about 8, between about 2 and about 6, or between about 2 and about 4spokes706.
• Therecording patch100 can include a plurality ofspokes706. Each spoke706 can include one ormore ports704. Each spoke706 may includeonly input ports704 oronly output ports704, or a combination thereof. Each port can include between about 2 and about 64, between about 2 and about 32, or between about 2 and about 12 contacts to make an electrical connection with the contacts ofleads106 orcables108. Thespokes706 or a portion thereof can be flexible to enable therecording patch100 to conform to the shape of the subject's skull. For example, the distal portion of thespokes706 can include a strain relief that enables flexing at or near theports704. Therecording patch100 can include a flexible or mechanical joint at the connection between thespokes706 and thehub708 to enable thespokes706 to deflect and conform to the shape of the subject's skull. Thespokes706 can project from thehub708 at a predetermined angle to conform to the shape of the subject's skull. Thehousing700, from a side profile, can include a convex shape that enables therecording patch100 to be secure against the subject's skull. The convex shape of therecording patch100 can substantially match the curvature of the subject's skull. Thehousing700 can be flexible to conform to the curvature of the subject's skull.
• Therecording patch100 can include a plurality ofports704. Therecording patch100 can include one ormore input ports704 and one ormore output ports704. Theinput ports704 can electrically couple with thepulse generator102 and theoutput ports704 can electrically couple with theleads106. For example, aport704 can receive a connection from thecable108. Theports704 can be similar to theports400 described above in relation toFIG. 4. For example, theports704 can each includeconnections402 that make electrical contact with the contacts of thelead106 or thecable108. Theports704 can include one ormore screws410 to secure acable108, cable to alead106, or other cable to theports704.
• Theoutput ports704 can electrically couple with alead106. The ports704 (both the input or output ports704) can be female or male ports. For example, theinput port704 can be a female port and theoutput ports704 can be male ports. Theoutput ports704 can include a cable tether. The cable tether can include a connector to couple thelead106 with therecording patch100. The leads106 can be permanently coupled with theoutput ports704. For example, a cable can extend from theports704. The distal end of the cable can include thelead106. Thelead106 can be permanently coupled with anoutput port704 when the cable orport704 does not include a connector that enables thelead106 to be disconnected form therecording patch100.
• Therecording patch100, as illustrated inFIGS. 7A and 7B can include ananchor702. Theanchor702 can be a component that separates from thehousing700. For example, theanchor702 can be a separate bracket that a medical professional can use to couple therecording patch100 to the subject's skull. Theanchor702 can be an integral portion of thehousing700. For example, theanchor702 cannot be separated from thehousing700. Theanchor702 can include a plurality of arms710. The arms710 can extend between each of thespokes706. The arms710 can terminate with an anchor point. The anchor point can be an opening or hole to receive ascrew410. Ascrew410 can be placed through each of the anchor points and screwed into the subject's skull to couple therecording patch100 to the subject's skull. Theanchor702 can include a medical grade metal, such as stainless steel or titanium
• FIG. 8 illustrates a block diagram of an example schematic of thesystem50. Thesystem50 can include therecording patch100 and aprogrammer800, which can be more generally referred to as an external source or a transmitter and receiver. Therecording patch100 can include thecontroller406, which can include arecording module802 and aselector module804. Therecording patch100 can includeswitches806 that can interconnect thecontroller406 andports400. Therecording patch100 can include apower source808 and theantenna404. Thesystem50 can include theprogrammer800. Theprogrammer800 can include an instance of theselector module804, anantenna404, and amemory element810. Therecording patch100 can include thecontroller406. Thecontroller406 can include therecording module802. Therecording module802 can include a plurality of amplifiers. For example, therecording module802 can include an amplifier for each of the lead's channels.
• Thecontroller406 can be an application specific integrated circuit (ASIC). Each of the electronic components of therecording patch100 can be components of thecontroller406. For example, theswitches806, theantenna404, and thepower source808 can each be components of controllers ASIC. Thecontroller406 and components of therecording patch100 can be divided among a plurality of ASICs.
• Therecording module802 can pass the incoming signals from thelead106 through its amplifiers to generate amplified signals based on the incoming signals. The amplifiers can have a gain between about 50 times to 5000 times, or between about 60 dB-120 dB. Therecording module802 can digitize the amplified signals. Therecording module802 can digitize the signals at a rate of between about 10 Hz and about 2000 Hz, between about 50 Hz and about 1000 Hz, or between about 50 Hz and about 20,000 Hz. Therecording module802 can perform pre-processing on the original or amplified signal. The pre-processing can include applying low, high, or band pass filters. For example, therecording module802 can band pass the original signal to remove electrical noise. Therecording module802 can band pass filter the signals to remove all but desired frequency ranges or bands. For example, therecording module802 can filter the signals to remove frequencies in the signals above about 100 Hz, 250 Hz, or about 500 Hz.
• Therecording module802 can communicate with theprogrammer800 via theantenna404. Therecording module802 can transmit the amplified signal to theprogrammer800 via theantenna404. Thecontroller406 can include theselector module804. Therecording patch100 and theprogrammer800 can each include instances of theselector module804. In some examples, only one of therecording patch100 or theprogrammer800 include an instance of theselector module804. For example, only theprogrammer800 may include an instance of theselector module804 and therecording patch100 can transmit data (e.g., electrical signals) to theprogrammer800 for analysis.
• Theselector module804 can select one or more electrodes of thelead106 over which a stimulation signal is delivered to the subject. Theselector module804 can select the electrodes to use for stimulation based on the signal characteristics of the signals received from thelead106. The characteristics can be the amount of power in a beta band of the received signals. The beta band can be between about 10 Hz and about 30 Hz, for example. Theselector module804 can select the electrodes that include the most power in the beta band as the electrodes to use for stimulation. Theselector module804 can select the electrode with the highest amount of power in the beta band as a stimulating electrode. Theselector module804 can select the electrodes having power in the beta band over a predetermined threshold as the stimulating electrodes. In some implementations, the electrode with the most power in the beta band can be selected. If a plurality of electrodes have power in the beta band, each of the plurality of electrodes can be selected as a multitude. If a multitude of electrodes is selected they may stimulate at the same signal amplitude, or at different signal amplitudes. If at different signal amplitudes, the individual single amplitudes applied to each electrode may be chosen to be proportional to the power of beta band detected. For example, if two electrodes display beta band power upon recording, with a first electrode demonstrating twice as much power as a second electrode, the signal amplitude for each electrode would be chosen such that the first electrode would have a signal amplitude twice as that of the second electrodes. In another use scenario, the signal amplitude could be applied between two or more electrodes that have each demonstrated beta band power.
• Therecording patch100 can include a plurality ofswitches806. Theswitches806 can be components of thecontroller406. Theswitches806 can selectively interconnect the connections in theport400 leading to thepulse stimulator102 to the connections in theport400 leading to thelead106. Theswitches806 can selectively interconnect the connections in theport400 leading to thelead106 to therecording module802. Selectively interconnecting, via theswitches806, can include connecting any of a port's connections to any input pins of thecontroller406 or other connections of anotherport400. In some implementations, the switches can be implemented as mechanical relays, micromechanical MEMS relays, electrical switches such as JFET, MOSFET, or other FET technology, or other microfabrication technology. In some embodiments, no switches are necessary, but a high impedance input to the recording module would be required. From this input a recording signal with high signal to noise can be captured, but stimulation signal from thepulse generator102 would not sink.
• Thecontroller406 can control theswitches806 to put therecording patch100 into a recording mode or a pass-through mode. For example, thecontroller406 can control the opened or closed state of theswitches806. During a pass-through mode, theswitches806 can couple the connections of afirst port400 with the connections of asecond port400. The pass-through mode can enable stimulation signals from thepulse stimulator102 to pass through therecording patch100 and to thelead106 without substantial alteration at therecording patch100.
• During a recording mode, theswitches806 can couple the connections of theport400 coupled with thelead106 with thecontroller406. Theswitches806 can couple each of the lead's electrodes with thecontroller406 or only a portion thereof.
• Therecording patch100 can include apower source808. Thepower source808 can be a rechargeable battery. Thepower source808 can include a super capacitor. Thepower source808 can be recharged wirelessly via theprogrammer800. For example, theantenna404 of theprogrammer800 and therecording patch100 can inductively couple to provide therecording patch100 with power. The power can be passed to thepower source808 to charge thepower source808.
• Theprogrammer800 can be an external data processing system. Theprogrammer800 can be a stand-alone device. Theprogrammer800 can be a mobile device such as a laptop, tablet, or smart phone. Theprogrammer800 can read and write data to therecording patch100 through wireless communication with therecording patch100 using theantennas404. For example, theprogrammer800 can receive and store digitized biological signals from therecording patch100. Theprogrammer800 can transmit configuration information, such as which connections of the ports to interconnect, to therecording patch100.
• Theprogrammer800 can include a screen to provide visual information to the user. The information can include readouts of the electrical signals received at each of the lead's electrodes, power within specified bands (e.g., the beta band) of the signals, or settings (e.g., which electrodes are configured as stimulation electrodes). The screen can be a touch screen. Theprogrammer800 can include anantenna404 that can be inductively coupled with theantenna404 of therecording patch100 to transmit data and power to between the devices. Via the screen theselector module804 can display one or more characteristics of the received signals. Via the screen theselector module804 can display plots of power within, for example, the beta band. Via the screen theselector module804 can display indications or approximations of the signals' characteristics. For example, theselector module804 can indicate whether a given channel has a “low,” “medium,” or “high” level of power in the beta band.
• Theprogrammer800 can include anantenna404. Theantenna404 of theprogrammer800 can have a diameter that provides efficient communication with thepatch100 via theantenna404 of thepatch100. For example, theantenna404 of theprogrammer800 can have a diameter between about 25 mm and about 85 mm or between about 45 mm and about 55 mm while theantenna404 of thepatch100 can have a diameter between about 15 mm and about 35 mm or between about 20 mm and about 30 mm. Theprogrammer800 can communicate with thepatch100 wirelessly after the implantation of thepatch100. Theprogrammer800 can send data to thepatch100 in order to set the recording parameters that thepatch100 uses to record electrical signals via thelead106. For example, theprogrammer800 can set which electrodes are used for the recording and the sampling frequency that is used to make the recording.
• Theprogrammer800 can download data (e.g., usage data, recorded physiological data, or device configuration information) from thepatch100. Theprogrammer800 can receive the data from thepatch100 in substantially real time (e.g., the data can be streamed to theprogrammer800 from the patch100). Thepatch100 can transmit the data to theprogrammer800 in batches. For example, thepatch100 can include an on-board memory to which the recordings from thelead106 are stored and then downloaded or transmitted to theprogrammer800. Once received by theprogrammer800, theprogrammer800 can store the data on thememory810. A user can later download the recording data from thememory810 to a data processing system for analysis. Theprogrammer800 can perform all or portions of analysis performed by the data processing system.
• Theprogrammer800 can be used to recharge the internal batteries of thepatch100. For example, theantenna404 of theprogrammer800 can be used to inductively couple power from an external power source to thepatch100. In some implementations, thepatch100 can have no internal power source and inductive power from theprogrammer800 can be used to power thepatch100.
• Theprogrammer800 can include an instance of theselector module804. The programmer'sselector module804 can perform any of the functions performed by the recording path'sselector module804. For example, theselector module804 can calculate characteristics of the signals detected by theleads106 and select one or more electrodes of thelead106 over which a stimulation signal is delivered to the subject. Theselector module804 can select the electrodes to use for stimulation based on the signal characteristics of the signals received from thelead106. The characteristics can be the amount of power in a beta band of the received signals. The beta band can be between about 10 Hz and about 30 Hz, for example. Theselector module804 can select the electrodes that include the most power in the beta band as the electrodes to use for stimulation. Theselector module804 can select the electrode with the highest amount of power in the beta band as a stimulating electrode. Theselector module704 can select the electrodes having power in the beta band over a predetermined threshold as the stimulating electrodes.
• FIG. 9A illustrates a block diagram of anexample method900 to record biological signals. Themethod900 can include implanting a recording patch (ACT902). Themethod900 can include coupling a plurality of connections with a recording module (ACT904). Themethod900 can include receiving biological signals (ACT906) and generating amplified signals (ACT908). Themethod900 can include determining characteristics of the signals (ACT910). Themethod900 can include selecting electrodes (ACT912).
• Themethod900 can include implanting a recording patch (ACT902). The recording patch can be any of the recording patches described herein. The recording patch can be implanted into a subject. The recording patch can include a first port that is configured to receive a connection from an implantable pulse stimulator. The first port can include a first plurality of connections. The recording patch can include a second port that can be configured to receive a connection from an implantable lead that is implanted into the subject. The lead can include a plurality of electrodes. The second port can include a second plurality of connections. The recording patch can include a plurality of switches that can be in electrical communication with the first plurality of connections and the second plurality of connections. The recording patch can include a recording module that is executed by one or more processors of the recording patch. The recording patch can include an instance of a selector module.
• The recording patch can be implanted beneath the subject's scalp following the implantation of one or more leads into the subject's brain. The leads can include a plurality of electrodes. The lead can include a plurality of electrodes positioned around the circumference of the lead at plurality of different axial locations. For example, at a plurality of different axial locations along the body of the lead's body, the lead can include an electrode at 0, 120, and 240 degrees. The lead can be implanted such that the lead's electrodes are positioned within the subject's subthalamic nucleus.
• Themethod900 can include coupling a plurality of connections with a recording module (ACT904). Thepatch100 can include a first and a second port. One port can be coupled with an implanted lead and be referred to as a lead port and one port can be coupled with an implanted stimulator and be referred to as a stimulator port. At a first time point after the implantation of the recording patch, the recording patch can wirelessly receive instructions that place the recording patch in a recording mode. In the recording mode, the recording patch's switches can couple one or more of the lead port's connections to the recording module. During the recording mode, the recording patch can inductively couple with a programmer or other external source to wirelessly receive power that powers the recording patch.
• At a second time point before or after the recording patch collects recordings of biological signals from the subject, the recording patch can receive instructions can cause the recording patch to configure one or more of the switches in a pass-through configuration such that the switches couple connections of the lead port with connections of the stimulator port. In a pass-through configuration, the connections between the first port and the second port can bypass the recording module and stimulation signals can be delivered to the subject prior to or after the recording phase.
• Themethod900 can include receiving biological signals (ACT906). During the recording mode, the recording patch can receive biological signals. The recording patch can receive the biological signals via the one or more electrodes that are connected to the lead port's connections to pass the biological signals to the recording module. The biological signals can be electrical activity generated by the brain or other neurological tissue. For example, the biological signals can be LFPs.
• The subject can perform physical acts during the receiving and recording of the biological signals. For example, the subject can perform one or more of, but not limited to, the following acts on one side or both sides of the body simultaneously: general movement, rest entire body, moving upper limbs, moving fingers, moving wrists, moving elbows, moving lower limbs, moving toes, moving ankles, moving knees, moving thighs, moving hips, moving extremities, moving head, moving neck, talking, clearing throat, swallowing, coughing, and speaking.
• The method can include generating amplified signals (ACT908). The patch can include one or more amplifies. The patch can pass the biological signals through the amplifies to generate amplified signals. The amplifiers can have a gain of between about 50 and about 5000× or between about 60 dB and about 120 db. The recording patch can sample the biological signals at between about 1 kHz and about 32 kHz, between about 8 kHz and about 32 kHz, between about 12 kHz and about 32 kHz, or between about 24 kHz and about 32 kHz.
• The recording patch can perform pre-processing on the biological signals or the amplified signals. The pre-processing can include band pass filtering, high or low pass filtering, smoothing, down sampling, up sampling, or a combination thereof. For example, the signals can be band pass with a filter having a pass band between about 5 Hz and about 5 kHz. The pre-processing can include applying a notch filter (at about 50 Hz or about 60 Hz) to remove power-line noise. The recording patch can perform the pre-processing digitally once the biological signals are digitized by the recording module or by one or more analog filters that can process the biological signals prior to the digitization of the biological signals.
• Themethod900 can include determining characteristics of the signals (ACT910). The characteristics of the signals can be determined by the recording patch's recording module or selector module. The recording patch's controller can determine the characteristics of the biological signals or the amplified signals. The recording patch can also wirelessly transmit the amplified signal to an external device (e.g., a programmer or other device) that can determine the characteristic of the signals. An instance of the selector module executed by the recording patch and an instance of the selector module executed by a programmer can cooperatively work to determine the characteristics of the signals. For example, the recording patch can perform pre-processing and filtering and then the programmer's instance of the selector module can determine the power within the beta band of the signals.
• The characteristic of the signals can be a power level in a beta band of each of the amplified biological signals. The recording patch or the external device can divide the amplified biological signals into a plurality of segments. For example, the biological signals can be divided into 15 second segments. The power in each segment can be calculated using the Welch method using a 1 second Hanning window with a frequency resolution of 1 Hz. The power of different frequency bands can be calculated as the area under curve of the power spectral density curves. For example, the recordings can be divided into a plurality of bands, such as alpha (7.5-12 Hz), low beta (12.5-16 Hz), medium beta (16.5-20 Hz) and high beta (20.5-30 Hz).
• Themethod900 can include selecting electrodes (ACT912). Themethod900 can include selecting an electrode of the plurality of electrodes based on the at least one signal characteristic of the biological signal. For example, the controller or the programmer can select each of the electrodes that received a biological signal having a power in the beta band above a predetermined threshold. The controller or the programmer can select the electrode that received a biological signal having the highest power in the beta band. The one or more selected electrodes can be used as stimulating electrodes. The selector module can select the electrode at each axial position with the highest power in the beta band. In some implementations, the selector module can select a plurality of electrodes. For example, the selector module can select the plurality of electrodes with the two, three, etc. highest level of power in the beta band.
• At a time point after the stimulating electrodes are selected, the recording patch can connect the implantable pulse stimulator to the selected electrodes. For example, the connections electrically coupled with the pulse stimulator can be coupled with the connections at the lead port that are in electrical communication with the selected electrodes. The recording patch can place the switches in a pass-through configuration such that the switches couple the connections of the two ports together while bypassing the controller.
• When in the pass-through configuration, the pulse stimulator can generate a stimulation signal that is transmitted to the selected leads via the recording patch. Once the patch is configured into the pass-through configuration, the external power supply from the recording patch can be removed. The external power supply can be removed prior to transmitting the stimulation signal to the electrodes selected as stimulation electrodes. The acts of themethod900 can be repeated at predetermined time points or intervals. For example, during doctor visits the physician can place the recording patch into a recording mode to retrieve electrical signals from each of the electrodes and the selector modules can re-determine which of the electrodes are receiving electrical signals with the highest power in the beta band. During different iterations of themethod900, different electrodes can be selected as stimulating electrodes. For example, during a first iteration of the method900 a first plurality of the electrodes can be selected as stimulation electrodes. At another time point during a second iteration of the method900 a second plurality of electrodes (which can be a subset of the first plurality of electrodes or a different plurality of electrodes) can be selected and coupled with the recording module.
• FIG. 9B illustrates a block diagram of anexample method920 to receive biological signals. Themethod920 can be used in conjunction with the ACTs of themethod900. For example, themethod920 can be used atACT908 of themethod900. Themethod920 can include collecting resting signals (ACT922). Themethod920 can include asking a subject to perform an action (ACT924). Themethod920 can include collecting signals during the action (ACT926). Themethod920 can include determining whether the subject should perform another activity (ACT928). The method can include stimulating the subject (ACT930). Themethod920 can include receiving biological signals (ACT932).
• As set forth above, themethod920 can include collecting resting signals (ACT922). The signals can be biological signals. For example, the biological signals can be electrical activity generate by brain or other neurological tissue. For example, the biological signals can be LFPs. The subject can be asked to relax or otherwise not move as the resting signals are collected. For example, the subject can be asked to recline, sit, or lie down as the recording patch collects the signals. To record the signals, the programmer can set the recording patch to the recording mode. The recording patch can receive the biological signals via the one or more electrodes of the lead. The recording patch can collect or otherwise record the resting signals as the subject rests (e.g., does not substantially move). The recording patch can collect the resting signals at a predetermined time interval after the subject begins to rest. For example, the subject can be asked to recline and the recording patch can begin to collect the resting signals about 1 minute, 5 minute, 10 minutes, or 15 minutes after the subject begins to recline.
• Themethod920 can include asking the subject to perform an activity (ACT924). A medical professional can request that the subject perform an activity or action when prompted by the programmer. The activity can include moving certain parts of the body, walking, turning, standing, coughing, speaking, throat clearing, swallowing, blinking, winking, squinting, performing hand gestures, performing finger gestures, performing elbow movements, performing shoulder movements, breathing, or halting the breath, among others. The medical professional can ask the subject to physically perform the activity or the medical professional can ask the subject to visualize or imagine performing the activity.
• Themethod920 can include collecting signals during the activity (ACT926). The signals can be biological signal as described above in relation toACT922. The biological signal can be collected as the subject performs (physically or mentally) the activity ofACT924. The signals can be recorded immediately following the completion of activity. For example, the recording patch can record thesignals 1 min, 5 min, 10 min, 15 min, or 30 min after the completion of the activity. The biological signals recorded atACT922 andACT926 can be continuously recorded during a testing session. For example, the recording patch can be placed into a recording mode prior to the medical professional asking the subject to rest and then continue recording through the ACTS of themethod920. The medical professional or the programmer can annotate the recorded signal to indicate the transitions between different phases of the testing session. For example, via the programmer, the medical professional can indicate when the subject begins to rest and when the subject begins or ends the activity. The programmer can record the time of the indication or can set a flag in the recorded signal to indicate each of the transitions.
• Themethod920 can include determining whether to test another activity (ACT928). The programmer can be loaded with testing policy that can indicate the one or more activities that the subject should perform during themethod920. A medical professional can select or configure the activities stored in the testing policy. The programmer can determine whether there are additional activities to ask the subject to perform. If there are additional activities to perform, themethod920 can return to theACT922. For example, determining there are additional activities to perform, the programmer can display a message to the medical professional to request that the medical professional ask the subject to rest. After the recording patch records additional resting signals (e.g., repeats ACT922), the programmer can request that the medical professional instruct the subject to perform the next activity listed in the testing policy (e.g., repeats ACT924). The recording patch can collect the signal during or after the subject completes the next activity listed in the testing policy (e.g., repeats ACT926). Themethod920 can include repeating the ACTs922-926 until the programmer determines there are no more additional activities in the testing policy for the subject to perform.
• Themethod920 can include stimulating the subject via the lead (ACT930). Also referring toFIG. 1, among others, the programmer can send an instruction to the recording patch to place the recording patch in a pass-through mode, such that electrical stimulations from thepulse stimulator102 can pass from thepulse stimulator102 to thelead106. As described above, thelead106 can include a plurality of electrodes. Thepulse stimulator102 can individually address each of the plurality of electrodes. The programmer can select one or more of the plurality of electrodes to which the stimulation should be delivered from thepulse stimulator102. For example, thepulse stimulator102 can include a plurality of internal switches that can be opened or closed to electrically disconnect or connect, respectively, an electrode from a stimulation source of thepulse stimulator102. Thepulse stimulator102 can deliver the stimulation single to one electrode, a plurality of electrodes, or all of the electrodes of thelead106.
• Themethod920 can include receiving biological signals (ACT932). To receive biological signals, the programmer can place the recording patch back into the recoding mode. The recording patch can receive the biological signals via the one or more electrodes that are connected to the lead port's connections to pass the biological signals to the recording module. The biological signals can be electrical activity generate by brain or other neurological tissue. For example, the biological signals can be LFPs. The recording patch can receive or otherwise record the biological signal starting at the completion of the stimulation signal delivered atACT930. The recording patch can continue to record the biological signals for between about 1 min and about 30 min, between about 1 min and about 20 min, or between about 1 min and about 15 minutes following the completion of the stimulation signal. TheACT930 and theACT932 can be repeated a plurality of times. For example, theACT930 andACT932 can be repeated for each electrode of theleads106.
• Themethod920 can include determining characteristics of the recorded signal at different time points. For example, the characteristics of the biological signal post-stimulation or post-activity can be compared to the characteristics of the biological signal recording duringACT922 when the subject was at rest. The characteristics of the signals can be determined by the recording patch's recording module or selector module. The recording patch's controller can determine the characteristics of the biological signals. Determining the characteristics is further described in relation toFIGS. 10-14, among others. The recording patch can also wirelessly transmit the amplified signal to an external device (e.g., a programmer or other device) that can determine the characteristic of the signals. An instance of the selector module executed by the recording patch and an instance of the selector module executed by a programmer can cooperatively work to determine the characteristics of the signals. For example, the recording patch can perform pre-processing and filtering and then the programmer's instance of the selector module can determine the power within the beta band of the signals. The characteristic of the recorded signal can be the amount of power in a beta-band of the recorded signal. For example, the recording patch's controller can determine the change in the amount of power in the beta-band between the resting phase (e.g., during ACT922) and the amount of power in the beta-band after the stimulation signal is provided to the subject (e.g., during ACT932).
• FIGS. 10-13 illustrate the results of recordings made with a system similar to that described herein.FIG. 10 illustrates aplot1000 of a plurality of powerspectral densities1002. Each of the powerspectral densities1002 was generated from 30-second recordings for both moving conditions (top row) and resting conditions (bottom row). Each recording was split into fifteen two-second epochs to examine changes in power spectral densities over time. Across the conditions and subjects, no marked change was observed over time. Differences were primarily observed between subjects in terms of peak frequency (e.g., the frequency component with most signal energy) and in terms of directions. For example, forsubject1 during moving, peak power was concentrated between about 25 and about 30 Hz. Subject2 showed peak power during moving and resting between frequencies about 17 and about 27 Hz. Forsubject3, peak power was concentrated in a narrow band around 8 Hz. Subject4 had peak spectral densities between about 8 and about 15 Hz.
• FIG. 11 illustrates aplot1100 of power spectral densities for each of four subjects. Theplot1100 includes separate power spectral densities form the different lead electrodes pointed in the antero-lateral, medial, and postero-lateral directions. Theplot1100 illustrates that the four subjects experienced directional difference. For example, during moving, subject1 had peak power in the antero-lateral and medial directions with slightly less power in the postero-lateral direction. Subject2 showed peak power in the antero-lateral direction with visibly more power than in the medial or postero-lateral direction. During moving, subject3 had most power in the medial direction. Subject4 had increased power below 10 Hz in all three directions during moving, but concentrated spectral power in the medial direction during resting.
• During resting, the power spectral densities showed more directional differences than during moving. For example, subjects1,2, and3 had heightened activity in the antero-lateral direction with peak power at 27 Hz, 22 Hz and 9 Hz, respectively. Subject4 showed increased activity at 10 Hz in the medial direction.
• The power spectral densities were stored as ranked stimulation directions (e.g., 1st, 2nd, and 3rd best direction) and split the power spectral densities into four frequency bands (e.g., alpha, low beta, medium beta, and high beta). The directions were ranked from the highest beta activity to the lowest beta activity.
• FIG. 12 illustrates aplot1200 comparing different frequency bands to different stimulation directions. In each of the six plotted examples, the 1st best direction had more power than the 2nd and 3rd best directions. However, in half of the cases these directional differences between directions were not significant. For instance, no significant difference was observed in the alpha frequency band or in the low beta frequency band during moving and resting. Significant differences were detected in the medium and high beta frequency bands and were more pronounced in the high beta frequency band and was particularly marked during resting.
• FIG. 13 illustrates acomparison1300 of the spectral power for the two conditions in the different frequency bands. The first condition is moving and the second condition is resting. Thecomparison1300 illustrates thatsubjects1 and2 had most power during resting across the four frequency bands, whilesubjects3 and4 had no preferable condition. For the medium beta frequency band, moving and resting had similar power in these two subjects.
• The above plots inFIGS. 10-13 illustrate that the power spectral densities showed relevant activity between about 8 Hz and about 30 Hz. The beta band can be linked with motor functions and Parkinson's disease can be linked with an increase in beta oscillations in the subthalamic nucleus. On average the highest spectral power for medium and high beta bands was observed in the direction matching the 1st best stimulation direction, e.g., the direction with the largest therapeutic window.
• FIG. 14 illustrates anexample heat map1400 to illustrate the amount of beta activity recorded at each of the electrodes of the lead during a plurality of activities. Theheat map1400 can indicate the relative amount of beta activity recorded at each of the plurality ofelectrodes1406. The amount of beta activity can be calculated or otherwise determined as described above in relation toFIGS. 9A-13, among others. For example, the recording patch can record neurological activity as the subject performs a plurality of activities as described in relation toFIG. 9B. As illustrated inFIG. 14, a test was performed where the amount of beta activity was identified at 6different electrodes1406. Theelectrodes1406 can correspond to 6 electrodes of thelead106. The controller can determine the beta activity as (or immediately after) the subject performs one of a plurality ofactivities1402. Theheat map1400 can group theactivities1402 intogroups1404. Theactivities1402 can be grouped based on the region of the body that is activated when performing the respective activity. For example, the movement of the arm, bending of the wrist, and movement of the fingers can be grouped into a group called “upper limbs.” As illustrated inFIG. 14, theheat map1400 illustrates the amount of beta activity as the subject: is at rest; talking, clearing the throat; and swallowing (the “mouth” group); moving the arm, bending the wrist, and moving the fingers (the “upper limb” group); and walking, bending the leg, and rolling the ankle (the “lower limb” group).
• Theheat map1400 can be a matrix that visually illustrates, for eachelectrode1406—activity1402 combination, avalue1408 of beta activity detected by the recording patch. Thevalue1408 can be a color-coded indicator or a value-coded indicator. For example, as illustrated inFIG. 14, relatively low beta activity can be indicated by a lightly colored box and a relatively high beta activity can be indicated by a darkly colored box. Theheat map1400 can use any color mapping or other visual representation of values. For example, for a value-coded indicator, thevalue1408 can be a scored value between 1 and 10 or a relative term such as “high,” “medium,” or “low.” For eachvalue1408, the controller can normalize thevalue1408 between 0 and 1 (or other value). For example, the controller can set the highestbeta activity value1408 of the electrode-activity combinations to 1 and the lowestbeta activity value1408 of the electrode-activity combinations to 0. The values between the highest and lowest electrode-activity combinations can be scaled between 0 and 1. The scaling can be linear, logarithmic, binary, normalized, or non-linear.
• As illustrated inFIG. 14,directional electrodes2 and3 demonstrated a relatively high beta activity within the mouth and upper limb groups, respectively.Electrodes1,5, and6 also demonstrated beta activity to a lesser extent.Electrode4 did not demonstrate any beta activity. Based on theheat map1400, the programmer could therefore conclude thatdirectional electrode2 may cause side effects linked to the mouth and throat region. However, the programmer could conclude thatelectrode4 would be a good candidate for use in stimulation because of the low beta activity detected for each ofelectrode4's electrode-activity combinations.
• While operations are depicted in the drawings in a particular order, such operations are not required to be performed in the particular order shown or in sequential order, and all illustrated operations are not required to be performed. Actions described herein can be performed in a different order.
• The separation of various system components does not require separation in all implementations, and the described program components can be included in a single hardware or software product.
• Having now described some illustrative implementations, it is apparent that the foregoing is illustrative and not limiting, having been presented by way of example. In particular, although many of the examples presented herein involve specific combinations of method acts or system elements, those acts and those elements may be combined in other ways to accomplish the same objectives. Acts, elements and features discussed in connection with one implementation are not intended to be excluded from a similar role in other implementations or implementations.
• The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including” “comprising” “having” “containing” “involving” “characterized by” “characterized in that” and variations thereof herein, is meant to encompass the items listed thereafter, equivalents thereof, and additional items, as well as alternate implementations consisting of the items listed thereafter exclusively. In one implementation, the systems and methods described herein consist of one, each combination of more than one, or all of the described elements, acts, or components.
• As used herein, the term “about” and “substantially” will be understood by persons of ordinary skill in the art and will vary to some extent depending upon the context in which it is used. If there are uses of the term which are not clear to persons of ordinary skill in the art given the context in which it is used, “about” will mean up to plus or minus 10% of the particular term.
• Any references to implementations or elements or acts of the systems and methods herein referred to in the singular may also embrace implementations including a plurality of these elements, and any references in plural to any implementation or element or act herein may also embrace implementations including only a single element. References in the singular or plural form are not intended to limit the presently disclosed systems or methods, their components, acts, or elements to single or plural configurations. References to any act or element being based on any information, act or element may include implementations where the act or element is based at least in part on any information, act, or element.
• Any implementation disclosed herein may be combined with any other implementation or embodiment, and references to “an implementation,” “some implementations,” “one implementation” or the like are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described in connection with the implementation may be included in at least one implementation or embodiment. Such terms as used herein are not necessarily all referring to the same implementation. Any implementation may be combined with any other implementation, inclusively or exclusively, in any manner consistent with the aspects and implementations disclosed herein.
• The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”
• References to “or” may be construed as inclusive so that any terms described using “or” may indicate any of a single, more than one, and all of the described terms. For example, a reference to “at least one of ‘A’ and ‘B’” can include only ‘A’, only ‘B’, as well as both ‘A’ and ‘B’. Such references used in conjunction with “comprising” or other open terminology can include additional items.
• Where technical features in the drawings, detailed description or any claim are followed by reference signs, the reference signs have been included to increase the intelligibility of the drawings, detailed description, and claims. Accordingly, neither the reference signs nor their absence have any limiting effect on the scope of any claim elements.
• The systems and methods described herein may be embodied in other specific forms without departing from the characteristics thereof. The foregoing implementations are illustrative rather than limiting of the described systems and methods. Scope of the systems and methods described herein is thus indicated by the appended claims, rather than the foregoing description, and changes that come within the meaning and range of equivalency of the claims are embraced therein.

Claims (21)

1-20. (canceled)

21. An implantable device, comprising:

a housing to secure against a subject;

a circuit disposed in the housing, the circuit to:

receive, at least partially concurrent with presentation of a prompt to the subject to perform an activity, a first biological signal from the subject passed via a switch connected with a lead;

set, responsive to completion of the prompt, the switch to connect with a stimulator to pass a stimulation signal from the stimulator to the lead;

receive, subsequent to passing of the stimulation signal from the simulator, a second biological signal from the subject passed via the switch with the lead; and

determine a characteristic based on the first biological signal and the second biological signal.

22. The device ofclaim 21, comprising the circuit to:

receive, prior to the presentation of the prompt for the subject to perform the activity, a third biological signal; and

determine the characteristic corresponding to a difference between the second biological signal and the third biological signal.

23. The device ofclaim 21, comprising the circuit to:

receive, at least partially concurrent with presentation of a second prompt to the subject to perform a second activity in accordance with a policy, a third biological signal; and

determine a characteristic based on the first biological signal for the activity and the third biological signal for the second activity.

24. The device ofclaim 21, comprising the circuit to:

select, from a plurality of electrodes of the lead, an electrode to deliver the stimulation signal from the stimulator to the lead based on the characteristic of the first biological signal; and

receive the second biological signal from the subject via the electrode of the plurality of electrodes of the lead.

25. The device ofclaim 21, comprising the circuit to:

record the first biological signal over a first time window relative to the presentation of the prompt to perform the activity; and

record the second biological signal over a second time window relative to the passage of the stimulation signal.

26. The device ofclaim 21, comprising the circuit to determine the characteristic including a first power level in a beta-band of the first biological signal and a second power level in a beta-band of the second biological signal.

27. The device ofclaim 21, comprising the circuit to communicate with a programmer via an antenna to transmit at least one of the first biological signal or the second biological signal.

28. A programmer device, comprising:

one or more processors coupled with memory in communication with a recording patch, configured to:

transmit a first instruction to set the recording patch to receive, at least partially concurrent with presentation of a prompt to the subject to perform an activity, a first biological signal from the subject passed via a switch connected a lead;

transmit a second instruction to set the recording patch to set, responsive to completion of the prompt, the switch to connect with a stimulator to pass a stimulation signal from the stimulator to the lead;

transmit a third instruction to set the recording patch to receive a second biological signal from the subject passed via the switch connected with the lead; and

determine a characteristic based on the first biological signal and the second biological signal from the recording patch.

29. The device ofclaim 28, comprising the one or more processors to:

select, responsive to a determination to test the subject to perform another activity, a second activity from a plurality of activities in accordance with a policy; and

transmit a fourth instruction to set the recording patch to receive, at least partially concurrent with presentation of a second prompt to perform the second activity, a third biological signal from the subject passed via the switch.

30. The device ofclaim 28, comprising the one or more processors to:

determine, subsequent to the completion of the prompt, to not test the subject to perform another activity in accordance with a policy; and

transmit, responsive to the determination to not test the subject to perform another activity, the second instruction to set the switch to connect with the stimulator.

31. The device ofclaim 28, comprising the one or more processors to:

select, from a plurality of electrodes of the lead, an electrode to deliver the stimulation signal from the stimulator to the lead based on the characteristic of the first biological signal; and

transmit the third instruction to the recording patch to receive the second biological signal from the subject via the electrode of the plurality of electrodes of the lead.

32. The device ofclaim 28, comprising the one or more processors to:

record the first biological signal over a first time window relative to the presentation of the prompt to perform the activity; and

record the second biological signal over a second time window relative to the passage of the stimulation signal.

33. The device ofclaim 28, comprising the one or more processors to determine the characteristic including a first power level in a beta-band of the first biological signal and a second power level in a beta-band of the second biological signal.

34. A method, comprising:

receiving, by a recording patch secured against a skull of a subject, a first biological signal from the subject passed via a switch connected with a lead, concurrent with presentation of a prompt to the subject;

setting, by the recording patch, responsive to completion of the prompt, the switch to connect with a stimulator to pass a stimulation signal from the stimulator to the lead;

receiving, by the recording patch, subsequent to passing of the stimulation signal from the simulator, a second biological signal from the subject passed via the switch connected with the lead; and

determining, by the recording patch, a characteristic of the first biological signal and the second biological signal.

35. The method ofclaim 34, comprising:

receiving, by the recording patch, prior to the presentation of the prompt for the subject to perform the activity, a third biological signal; and

determining, by the recording patch, the characteristic corresponding to a difference between the second biological signal and the third biological signal.

36. The method ofclaim 34, comprising:

receiving, by the recording patch, at least partially concurrent with presentation of a second prompt to the subject to perform a second activity in accordance with a policy, a third biological signal; and

determining, by the recording patch, a characteristic based on the first biological signal for the activity and the third biological signal for the second activity.

37. The method ofclaim 34, comprising:

selecting, by the recording patch, from a plurality of electrodes of the lead, an electrode to deliver the stimulation signal from the stimulator to the lead based on the characteristic of the first biological signal; and

receiving, by the recording patch, the second biological signal from the subject via the electrode of the plurality of electrodes of the lead.

38. The method ofclaim 34, comprising:

recording, by the recording patch, the first biological signal over a first time window relative to the presentation of the prompt to perform the activity; and

recording, by the recording patch, the second biological signal over a second time window relative to the passage of the stimulation signal.

39. The method ofclaim 34, comprising:

determining, by the recording patch, the characteristic including a first power level in a beta-band of the first biological signal and a second power level in a beta-band of the second biological signal.

40. The method ofclaim 34, comprising:

communicating, by the recording patch, with a programmer via an antenna to transmit at least one of the first biological signal or the second biological signal.

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