WO2025146594A1 - Systèmes thérapeutiques à prescription numérique, modules d'excitation pour de tels systèmes et procédés d'utilisation associés - Google Patents

Systèmes thérapeutiques à prescription numérique, modules d'excitation pour de tels systèmes et procédés d'utilisation associés Download PDF

Info

Publication number
WO2025146594A1
WO2025146594A1 PCT/IB2024/062882 IB2024062882W WO2025146594A1 WO 2025146594 A1 WO2025146594 A1 WO 2025146594A1 IB 2024062882 W IB2024062882 W IB 2024062882W WO 2025146594 A1 WO2025146594 A1 WO 2025146594A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
pod
energizing
data
dpf
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/062882
Other languages
English (en)
Inventor
Jesse WHEELER
Andrew Czarnecki
Tal EIN-GAR
Eric Claude Leuthardt
Daniel W. Moran
Theodore Kucklick
Meron Gribetz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Inner Cosmos Inc
Original Assignee
Inner Cosmos Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Inner Cosmos Inc filed Critical Inner Cosmos Inc
Publication of WO2025146594A1 publication Critical patent/WO2025146594A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223—Circuits for electromagnetic coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37282—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data characterised by communication with experts in remote locations using a network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37514—Brain implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A61N1/3787—Electrical supply from an external energy source

Definitions

  • the present invention in some embodiments thereof, relates to the field of devices and systems for delivering a therapeutic treatment (electrical, or other therapy type) to a patient using one or more implants, and more particularly to such systems including a local subsystem capable of receiving and storing a digital data file for controlling therapy and for allowing the patient to set the values of one or more therapy parameters.
  • a therapeutic treatment electrical, or other therapy type
  • Brain recording and/or stimulating methods may also be used for modulating the brain physiology to enhance cognitive function in healthy individuals or to improve cognitive function in some patients having neuropsychiatric diseases affecting cognitive performance such as, inter alia, depression, ADHD, OCD, various eating disorders, epilepsy and many other psychiatric, neurodegenerative, neurological and neuropsychiatric disorders. Cortical sensing and stimulation may also be used to treat a wide array of motor disabilities.
  • Implantable devices with active electronics require a power source to operate, often implemented as a battery, large capacitor, or super-capacitor. Many implantable devices have an internal primary-cell battery to power active electronics that must be replaced after extended use depletes the battery’s stored energy. Replacing an implant’s battery requires a surgical procedure in which the component that houses the battery is disconnected, removed, and replaced with a new component that has a fully charged battery. This is repeated as often as the battery is depleted through use, resulting in additional costs related to the procedure and replacement parts and additional surgical risk to the patient.
  • the sensing parameters are selected from, the number of sensing electrodes to be used for sensing, the configuration of sensing electrodes to be used for sensing, the duration of a sensing time period(s) to be used, the time of initiation of sensing period(s) with respect to timing of stimulation periods and any combinations thereof.
  • the collected data representing objectively quantified parameters of use of the at least first portable communication device by the patient comprises data selected from one or more of, data representing use of one or more software applications of the portable communication device by the patient, data representing a number and/or frequency of calls made by the patient using the portable communication device, data representing a number or frequency of SMS text messages sent by the patient using the portable communication device, data representing the duration of phone calls made by the patient using the portable communication device, data representing the total number of times the screen of the portable communication device is turned on per day, data representing the total amount of patient’s screen time per day, data representing acceleration of the portable communication device, data representing the frequency of use and/or the total time of use of one or more software applications installed on the portable communication device, data representing the frequency of use and/or the total time of use of the one or more software applications categorized by application category, data representing the number of photos taken by the patient per day using the portable communication device, patient's call log data, patient's social network data, and any combinations thereof.
  • Data representing the number of photos taken by the patient
  • FIG. 3 is a schematic block diagram illustrating the components of an exemplary embodiment of an implant, usable in the systems of the present application
  • FIG. 4 is a schematic block diagram illustrating the components of an exemplary embodiment of an interactive wireless energizing pod useable in the systems of the present application.
  • FIG. 7 is a schematic block diagram, illustrating the components of a system for delivering therapeutic treatment to multiple patients supervised by multiple clinicians, in accordance with an embodiment of therapeutic systems of the present application;
  • FIG. 8 is a schematic isometric view of a magnetic wireless energizing pod, in accordance with an embodiment of the wireless energizing pods of the present application;
  • FIG. 9 is a schematic cross-sectional view of the energizing pod of FIG. 9, taken along the lines IX-IX;
  • FIG. 16 is a schematic flow diagram illustrating the steps of a method for creating a new DPF by the main server(s), in accordance with an embodiment of the methods of the present application;
  • FIG. 17 is a schematic flow diagram illustrating the steps of a method for performing a secure login by a patient application operating on one or more of the devices included in the local subsystems of the present application
  • FIG. 18 is a schematic flow diagram illustrating a method for connecting and data exchange between a patient application operating on one or more of the devices included in the local subsystems and a pod, in accordance with an embodiment of the patient application of the present application;
  • FIG. 20 is a schematic flow diagram illustrating a method for periodically cleaning up DPFs by a patient application, in accordance with an embodiment of the methods of the present application;
  • FIG. 21 is a schematic flow diagram illustrating a method (software subroutine) for using a patient application to enable the patient to set or modify the value of one or more patient modifiable therapy parameters included in a DPF, in accordance with an embodiment of the methods of the present application;
  • FIGs. 23A-23B are schematic flow diagrams illustrating the steps of an exemplary method (subroutine) included in the patient application and usable for initiating a therapy session, in accordance with an embodiment of the methods of the present application;
  • FIG. 24 is a schematic flow diagram illustrating the steps of a method (subroutine) for updating therapy files (DPF) on energizing pod(s) by a patient application, in accordance with the methods of the present application;
  • FIG. 27 is a schematic flow diagram illustrating the steps of an exemplary embodiment method or subroutine operable on an energizing pod of the present application and usable for initiating a therapy session by communicating with an implant and with a patient application installed on a device included in the local subsystem of FIGS. 1-2;
  • FIG. 28 is a schematic flow diagram illustrating the steps of an exemplary implementation of a method or subroutine operating on an energizing pod for directly initiating a therapy session by using a user interface of the energizing pod, in accordance with an embodiment of the methods of the present application;
  • FIG. 31 is a part cross-sectional diagram illustrating another possible implantation method of the implants usable in the systems of the present application.
  • FIG. 32 is a schematic flow diagram illustrating the steps of operation of a software application operable on a portable communication device included in the systems of FIGS. 1-2 and 7 for acquiring collected data representing objectively quantified parameters of use of the portable communication device.
  • Implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.
  • a data processor such as a computing platform for executing a plurality of instructions.
  • the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disc and/or removable media, for storing instructions and/or data.
  • a network connection is provided as well.
  • a display and/or a user input device such as a keyboard or mouse are optionally provided as well.
  • compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
  • patient When the term “patient” is used in the specification and in the claims of the present application in relation to an action performed by the patient during use of a software or program or subroutine, it may be construed as “either the patient or a user”. Such a user may be, for example, a medical technician or clinician operating the energizing pod and/or the external communication device for any purpose.
  • the term “clinician” is used herein to mean any person authorized to medically treat and/or supervise a patient, such as, for example, a physician or a psychiatrist.
  • the term “local subsystem” is used herein to mean one or more mobile and/or portable and/or hand held and/or wearable devices that may be located in the vicinity of a patient having a medical implant.
  • the one or more devices have computational processing power and communication capabilities, wherein at least one of the one or more devices is programmed to bidirectionally interact with the patient to provide information and instructions to the patient and to receive from the patient input that may be used to control at least some parameters of a therapeutic patient’s treatment performed by the implant.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
  • the systems described hereinafter may include multiple devices that are commonly connected to external computational devices (such as, for example, a smartphone) which could include smartwatches, wearable sensors, and earphones.
  • external computational devices such as, for example, a smartphone
  • This networking allows flexibility in connecting to networks of devices that are used in daily life and offers advantages over state of the art in integrating multi-modal data to improve diagnostic and predictive accuracy, providing feedback to patients and clinicians in a readily accessible manner and on-the-go, and also in leveraging inherent connectivity, security, and flow of information between devices and users.
  • FIG. 1 is a schematic block diagram, illustrating the components of a system including an implant for delivering therapeutic treatment to a patient, in accordance with an embodiment of therapeutic systems of the present application.
  • FIG. 2 is a schematic diagram illustrating a specific implementation of a therapeutic system, including an implant for delivering electrical therapeutic signals to the brain of the patient, in accordance with an embodiment of the systems of the present application.
  • the System 100 includes an implant 10 implantable in a patient 115.
  • the implant 10 is designed to deliver therapeutic treatment to the patient 115.
  • the system 100 may also include a local subsystem 14 in communication with the cloud 9 over the internet.
  • the system 100 may also include a clinician workstation 13 that may be connected to the cloud 9 over the internet in a wireless or wired communication method.
  • the system may also include a main server 12 that may be connected to the cloud 9 over the internet in a wireless or wired communication method.
  • the clinician workstation 13 may be any type of a computing device connectable to the internet, such as for example, a desktop computer, a laptop computer, a server, a tablet, a phablet, a smartphone, or any other type of computing device having wired and/or wireless communication capabilities.
  • the main server 12 may be any type of a computing device connectable to the internet, such as for example, a server, a desktop computer, a workstation or any other type of computing device having wired and/or wireless communication capabilities and capable of communicating over the internet.
  • the main server 12 may be situated at the headquarters of a company providing clinicians with clinical services or may be situated in a server farm anywhere and operated by such a company.
  • the main server 12 may perform various identification, authentication, validation and clinical service functions.
  • the main server 12 may be used for storing and maintaining a master database for recording various clinician and patient data, patient treatment history, and other types of data.
  • the main server 12 and/or the clinician workstation 13 may wirelessly receive (over the internet) relevant data from the system 100 or 200 for storing in a database including the long-term history of the operation of the system 100 or 200 for each individual patient.
  • Such a database may record, inter alia, data representing the stimulation parameters used in each stimulation session on the patient 115, data representing the 2D location in the Cartesian coordinate system (x,y) of the computed centroid of the biomarker(s) peak intensity, the computed size and/or shape of the biomarker(s) intensity map computed using the linear Gaussian approximation method (disclosed in detail in published international application WO/2021/144730, EMA data or any other patient-related data obtained before the stimulation session, the HRV data obtained prior to a stimulation session, and any other clinically relevant data helpful to the psychiatrist or physician or caretaker monitoring the treatment of the patient 115.
  • This data stored in the historical database may enable the clinician (or caretaker) to follow up and supervise the effects of the therapeutic treatment of the patient 115 in order to assess therapeutic efficacy of the treatment over time.
  • the clinician workstation 13 may also be used for presenting the data in graphical for use by the caretaker. Additionally, the clinician workstation 13 may be used by the clinician or psychiatrist to remotely and wirelessly reprogram and change any selected parameters of the stimulation regime deliverable in stimulation sessions, to change or modify the efficacy of treatment, based on the historical database data, or, during an initial stimulation fine-tuning time period that may enable the determining of individually tailored stimulation paradigms to each individual patient.
  • the clinician or caretaker may change any of the stimulation session parameters such as, for example, the anodic pulse amplitude, the cathodic pulse amplitude, the anodic pulse duration, the cathodic pulse duration, the inter-pulse interval within a pulse train, the frequency of pulses within a pulse train, the number of pulses in a pulse train, the frequency of trains (the intervals between trains), and the number of pulse trains delivered within a stimulation session.
  • the stimulation session parameters such as, for example, the anodic pulse amplitude, the cathodic pulse amplitude, the anodic pulse duration, the cathodic pulse duration, the inter-pulse interval within a pulse train, the frequency of pulses within a pulse train, the number of pulses in a pulse train, the frequency of trains (the intervals between trains), and the number of pulse trains delivered within a stimulation session.
  • Such individually tailored stimulation session parameters may be stored in the database and may be communicated, wirelessly and uploaded to the energizing pod 19 or the smartphone 11 or the personal laptop 15 for wirelessly uploading to the implant 10 directly or through the pod 19.
  • the implant 10 may be any type of implant capable of delivering therapeutic treatment to the patient, including, for example, electrical signal therapy to the brain or to any part of the peripheral and/or central nervous system, drug delivery therapy and any combinations thereof.
  • the implant 10 may also perform sensing of electrical signals or of any other bio- signals or other patient related signals (such as, for example, heart rate, blood pressure, rate and frequency of patient's movements, or any other suitable patient related signal) from the patient, in order to monitor the patient’s condition as well as to assess the efficacy of therapy.
  • the local subsystem 14 may include one or more mobile and/or portable and/or wearable devices (not shown in detail in FIG. 1, for the sake of clarity of illustration). However, FIG. 2 below illustrates a specific description of such a local subsystem. Such devices may be carried by the patient 115 or may be worn by the patient 115 and/or may be carried by the patient 115 or at least may be locally available to be accessed the patient at least part of the patient’s time.
  • the local subsystem 14 may include one or more smartphones, one or more phablets with wireless communication capabilities one or more wirelessly energizing pods (as described in detail hereinafter with respect to FIGS.
  • the system 200 may include the implant 10 (of FIG. 1) implanted in the calvarial bone of the head 3 of a patient 115 suffering from a mood disorder (such as, for example, depression).
  • a mood disorder such as, for example, depression
  • the implant (or devices) of system 200 may also be any of implants disclosed in the present application or disclosed in International published applications WO/ 2019/130248, WO/2020/161555 and WO/2021/144730.
  • the system 200 may also include a detachably attachable wirelessly energizing pod 19 for wirelessly providing electrical energy to the implant 10.
  • the pod 19 may also be configured to bi-directionally wirelessly communicate with the implanted device 10 and may relay data, status signals and commands signals from and to the implant 10 and/or to one or more of the other components included in the system 200.
  • the system 200 may also include a smartphone 11, a wearable smart watch 117, a personal laptop 11, a main server 12 and a clinician workstation 13.
  • the system 200 may also include an energizing pod charger 17 that may be used for charging a power source (not shown in FIG. 2 for the sake of clarity of illustration, but described in detail with respect to FIG. 5 hereinafter) included in the pod 19.
  • the system 200 may (optionally) include one or more additional pods 29 which may be used instead of the pod 19 if it is not charged or if it malfunctions.
  • re-charging of the pods 19, 29 and 39 may be implemented by electrical contact between electrically conductive pins (or pads) on the energizing pod with corresponding electrically conductive pins (or electrically conducting pads) on the pod charger 17 (as disclosed in detail in FIGS 8-10 hereinafter).
  • re-charging is implemented by establishing a wireless power link between the energizing pod and the pod charger, such that the energizing pod receives energy wirelessly transmitted from the pod charger when docked to it (in such an embodiment there are no electrically conductive pins/pads in the energizing pod or in the pod charger, as the power is wirelessly transmitted).
  • the implementation of such wireless charging of an energizing pod may be similar to wireless charging commercially used in high end smartphones.
  • the energizing pod may also exchange data with the pod charger through electrical contact between the electrically conductive pins (or pads) on the energizing pod and the conductive pins (or pads) on the energizing pod charger when the pod(s) are docked in the pod charger.
  • the pod charger may include docking members to detachably connect the pod charger to a handheld computing device.
  • docking the pod charger 17 with a handheld computing device may include electrically connecting the pod charger 17 to a port on the handheld computing device (such as, for example, the smart phone 11 or the laptop 15) via a mating connector (not shown) to facilitate direct power transfer and data exchange.
  • the patient application may issue notifications to the patient 115 that an updated digital prescription is available. Such notifications may be delivered by any desired combination of text, icon, or graph.
  • a notification may include an auditory signal or a vibration.
  • a timer may be displayed to the patient 115 by the patient application that represents how much time has expired or remains for a stimulation session.
  • the timer may be displayed as any combination of alphanumeric text, graph, or image.
  • the user may have control over a subset or all therapy parameters, including stimulation amplitudes, pulse widths, frequencies, burst frequencies, pulses in a train, trains in a session, number of sessions a day, etc.
  • the DPF may restrict various stimulation parameters based upon authentication of who the user is.
  • the (optional) smartwatch 117 may be any type of smartwatch that has the capability to sense and record one or more physiological parameter of the patient 115, when the patient 115 wears the smartwatch 117.
  • the smartwatch 117 may be able to record the heart rate (HR) of the patient 115 or other physiological parameters of the patient 115 that may be indicative of or may be correlated to the mood of the patient 115.
  • the smartwatch 117 may wirelessly communicate with the smartphone 11 that may receive the heart rate data from the smartwatch 117.
  • the smartphone 11 may have a suitable application installed therein that may use the HR data to compute the heart rate variability (HRV) of the patient 115.
  • the HRV parameter is known to be correlated with the severity of depressed mood of depressive patients.
  • EMA data may be collected using the smartphone 11 of the system 200 as described in detail in international published application WO/2019/244099 and the references cited therein which are incorporated herein by reference in their entirety for all purposes.
  • the systems/methods of the present application may use iYouVU, a faceless mobile phone application based on the Funf open- sensing-framework (Aharony, N., Gardner, A., Sumter, C., & Pentland, A. (2011). Funf: Open sensing framework.), and prior research into communication habits based on mobile phone data collected without the user’s full awareness.
  • This application runs in the background, unnoticeable to the user, to automatically collect designated sensor data and application logs.
  • the application logs call events (i.e., time/date of the call, duration, and contact of both incoming and outgoing calls), short message service (SMS) text message events (i.e., time/date and contact), screen on/off events (i.e., time/date), application use (i.e., what applications were launched, when, and for how long), and mobile phone camera use (i.e., the time/date a picture was taken). All collected sensitive personal data, such as contact details (names, phone numbers), may be anonymized during data collection by the application through the built-in cryptographic hash functions of the Funf framework.
  • the processing and/or computations may be offloaded to the cloud remote server that may communicate any computed values (such as, for example MX and/or MI disclosed in detail hereinafter) over the internet (using WiFi or cellular data transmission protocols, or any other suitable communication protocols) to the smartphone 11 and/or to the laptop 15 for use and/or for telemetrically sending such values to the implant (such as, for example, the implant 10 of FIGS. 1-2, the implants 10A-10K of FIG.7, the implant 28 of FIG. 3, the implant 52 of FIG. 5, the implant 62 of FIG. 6 and the implant 72 of FIG. 31.
  • the implant such as, for example, the implant 10 of FIGS. 1-2, the implants 10A-10K of FIG.7, the implant 28 of FIG. 3, the implant 52 of FIG. 5, the implant 62 of FIG. 6 and the implant 72 of FIG. 31.
  • raw EMA and unobtrusive EMA data may be preprocessed into a data file that summarized each day of each participant in a row of 53 variables.
  • EMA data i.e., both the one-dimensional mood measure and the two measures of the circumplex model, valence and arousal
  • Daily averages are standardized within each participant (i.e., using means and standard deviations calculated for each participant separately).
  • Raw screen on/off events of the communication device (such as, for example the smartphone 11, the laptop 15, the smartphone 117, a tablet or a phablet) are transformed into two features: (1) the total number of times the screen is turned on per day and (2) the total amount of screen time per day (calculated as the differences between the times of the screen on/off events). Both features are transformed to standard normal variables within each participant.
  • Accelerometer data represents the acceleration of the smartphone 11 on the x, y, and z planes. Acceleration is sampled for 5 seconds each minute (at sample frequencies estimated to vary from 20-200 Hz, as determined by the hardware and software characteristics of participants’ mobile phones). Raw data are summarized (on the phone through Funf’s Activity Probe) into a high activity variable by calculating the percentage of time at which the summed variance of the device’s acceleration (on the x, y, z planes) was above a set “high activity” threshold (i.e., in which the summed variance exceeded 10 m/s 2 ). These percentages are aggregated to the day level to provide an approximate measure of daily activity.
  • Mobile Phone camera logs are used to determine the number of photos taken per day. Next, this number of photos taken per day data is transformed to the 0-1 scale for each participant separately by dividing all values by the maximum number of photos taken.
  • the external communication device may also be implemented as a smartwatch.
  • the smartwatch 117 includes a SIM or an eSIM and is capable of making telephone calls by itself
  • the application for automatically acquiring EMA data and/or collected data representing objectively quantified data of parameters of use of the communication device by the patient may be installed in the smartwatch 117 and may operate thereon to automatically collect such data in the background.
  • the smartwatch 117 may also be used to collect additional sensor’s data using any sensors included in the smartwatch 117 as described in detail hereinabove or hereinafter.
  • the results of this stimulation may also be periodically interrogated with ecological momentary mood assessments (EMA) or with automatically acquired collected data representing objectively quantified parameters of use of the communication device (such as, for example, the smartphone 11, the laptop 15, the smartwatch 117, or any other communication device included in the local subsystem 14 such as a tablet, a phablet, ) to determine the impact of the stimulation on the reported mood and the resultant patient physiology.
  • the stimulation parameters may also evolve and change. This could include changes in amplitude of stimulation, stimulating pulse width, and pulse frequency.
  • the end result is a dynamic recording and stimulating system that continually self-assesses performance based on the patient's reporting. This will enable biomarkers to not only be patient specific, but also to adjust over time should the patient’ s baseline physiology be non- stationary or should their fundamental brain states and physiologies change over time.
  • a communication device is included in the local subsystem 14.
  • the communication device may be, for example the smartphone 11, the smartwatch 117, the personal laptop 15, a tablet (not shown), a phablet (not shown) or any other portable communication device having computational and communication capabilities).
  • the communication device may have an application software program or subroutine installed thereon and operation in the background for automatically acquiring collected data representing objectively quantified parameters of use of the communication device by the patient.
  • FIG. 32 is a schematic flow diagram illustrating the steps of operation of a software application operable on a portable communication device included in the systems of FIGS. 1-2 and 7 for acquiring collected data representing objectively quantified parameters of use of the portable communication device.
  • the software application may be operated in the background to acquire collected data representing objectively quantified parameters of use of the communication device by the patient (step 530).
  • the collected data may be acquired for a preset time period that may be determined by the clinician.
  • the time period may be twenty-four hours.
  • the time period of collecting the data may be any suitable time period, such as, for example, twelve hours, or six hours or any other desired time period, depending, inter alia, on the specific individual patient typical behavior during the day and night hours, the clinicians’ decision based on historical data indicating the most active time periods of use of the communication device during the day, and other considerations.
  • the collected data representing objectively quantified parameters of use of the communication device by the patient may include data selected from one or more of, data representing use of one or more software applications of the portable communication device by the patient, data representing a number and/or frequency of calls made by the patient using the portable communication device, data representing a number or frequency of SMS text messages sent by the patient using the portable communication device, data representing the duration of phone calls made by the patient using the portable communication device, data representing the total number of times the screen of the portable communication device is turned on per day, data representing the total amount of patient’s screen time per day, data representing acceleration of the portable communication device, data representing the frequency of use and/or the total time of use of one or more software applications installed on the portable communication device, data representing the frequency of use and/or the total time of use of the one or more software applications categorized by application category, data representing the number of photos taken by the patient per day using the portable communication device, patient's call log data, patient's social network data, and any combinations thereof.
  • Data representing the portable device configuration such as screen brightness
  • the data collected by the communication device may also include in addition to the objectively quantified parameters of use of the communication device by the patient, other types of data such as, for example, subjective data of mood self-assessment acquired by requesting the patient to subjectively assess his or her mood (the assessment may be performed using any of the methods described in detail in Published international application WO /2019/244099 and in LiKamWa et al.)
  • the program may periodically check if the preset data collection time period has passed (step 532). If the data collection period has not passed, the program continues to acquire the collected data by returning control to step 530. If the data collection time period has passed, the program stores the collected data (either in the memory of the communication device or in the cloud) and may send the collected data to other devices of the system (step 534), and transfers control to step 530 to acquire collected data for the next data collection time period.
  • the data may either be immediately sent to the other devices of the system (such as, for example, the Clinician’s workstation 12 and/or the main server(s) 13), provided that communication with the other devices may be established by the communication device (in such embodiments, the communication device actively pushes the collected data to the other devices).
  • the stored collected data may be sent or communicated to the other devices at preset time or times within the day (for example, any stored collected data may be communicated to the clinician’s workstation 12 and the main server(s) 13 at 12 PM each day or at any other desired time or times every day.
  • the version number is necessary because as the system is developed and refined, there may be changes implemented in the structure, order and contents of the data fields in the DPF and ICF. Therefore, the version number of the DPF and ICF files may be used by the patient application to recognize and properly read the data fields of the file.
  • the use of the version numbers in the DPF and ICF allows adding and/or removing data fields, as the system is developed.
  • the patient application identifies that the file version is not supported by the patient application, it will prompt the user that there is a versioning problem and that he/she needs to download the latest patient application version (from the main server(s) 12).
  • the unique therapy identifier is an integer number that uniquely identifies the therapy session to be delivered.
  • the digital prescription file is a data structure (including multiple data fields) that includes all the data of the DPF as described in TABLE 1 above.
  • the ICF also includes P numerical values of therapeutic parameters selected by the patient 115. P could be any integer number of parameters that may be modified by the patient 115 as is determined by the clinician when the DPF is generated on the clinician workstation 13.
  • TABLE 3 represents an exemplary embodiment of a “therapy log” that may be logged by the implant 10 or 28.
  • the therapy log may be saved at the end of a therapy session (For example, steps 470 and 472 of FIG. 28 hereinbelow describe such logging).
  • the implant 28 may include at least one processor/controller(s) 140, a power harvesting module 145, a first electrode selecting module 120, a signal conditioning module 122, a digitizing/ multiplexing module 139, a multichannel voltage pulse generator module 170 and a second electrode selecting module 124.
  • the power harvesting module 145 may include an inductance coil 55 for receiving electromagnetic energy transmitted from an external energizing coil (not shown) that may be included in an external energizing device (such as for example, the energizing pods 19 and 29 of FIG. 2). It is noted that the construction and operation of such external energizing coils is well known in the art, is not the subject matter of the present application and is therefore not described in detail herein. For example, US patent No. 6,246,911 to Seligman discloses the construction and use of inductance coils for energizing cochlear implants.
  • the implant 10 and 28 there may not be an internal energy storage device, such that the implant is directly powered by the energizing pod.
  • the implant 10 or 28 may include a small energy storage device suitable for temporarily maintaining power during brief periods where the wireless power transfer from the energizing pod is lost.
  • the energy storage device is not shown in FIG. 3 for the sake of clarity of illustration).
  • Such an energy storage device may be, for example, a rechargeable battery, a capacitor or multiple capacitors, a supercapacitor or multiple supercapacitors.
  • the implant may include a larger energy storage device (not shown) that may support primary use of the implant’ s functions but is periodically re-charged.
  • Such energy storage devices include batteries, capacitors, and supercapacitors.
  • the sensing/recording electrodes 25 A, 25B, 25C and 25D and the reference electrode 30E of the implant 28 may be electrically and switchably connectable to the first electrode selecting module 120 of the implant 28.
  • the first electrode selecting module 120 may be implemented as a solid-state multi-channel switching device.
  • the first switching module 122 is suitably coupled to the signal conditioning module 122.
  • the first switching module 120 is suitably connected to the processor/controller (s) 140 that controls the switching operation of the first switching module 122 which may controllably connect or disconnect any selected electrodes from the signal conditioning module 122.
  • the signal conditioning module 122 may include electronic circuitry suitable for performing various signal conditioning types on the electrical cortical signals fed from the sensing/recording electrodes 25A, 25B, 25C and 25D.
  • the signal conditioning operations may include signal filtering, frequency band limiting, low pass filtering, or any other type of desired signal conditioning operations.
  • the conditioned signals may be then fed into suitable channel amplifiers 80 for amplifying the conditioned signals performing differential recording against the reference signal fed from the reference electrode 30E.
  • the conditioned amplified signals output from the amplifiers 80 may be (optionally) digitized by the (optional) digitizing/multiplexing module 139 to form digitized signals.
  • the digitizing/multiplexing module 139 may be suitably coupled to the processor/controller(s) 140 for controlling the digitizing and/or multiplexing operations thereof.
  • the digitized signals may be further filtered, averaged, decimated to a lower sampling rate, and/or compressed to reduce data throughput.
  • the digitized signals may be fed into the telemetry module 138 for wirelessly transmitting to an external receiver (or transceiver) outside the body of the patient.
  • the external receiver or transceiver may be the wireless power transmitter/data transceiver module 22 or the transceiver 20 or the transceiver 18 of the energizing pod 19 (of FIG. 4 below).
  • the digitized signals transmitted from the implant 28 may be further processed and/or stored by the energizing pod 19 (or pod 29).
  • the conditioned/amplified analog signals output from the amplifiers 80 are not digitized and are fed to the Telemetry module 138 to be transmitted to the external receiver or transceiver (not shown).
  • the processor/controller(s) 140 may be operatively connected to the telemetry module 138 for controlling the operation thereof.
  • the processor/controller(s) 240 may include integral memory unit(s) 142 or may additionally or alternatively be connected to one or more suitable data storage device (not shown).
  • the digitized recorded signals may be sent directly to the processor/controller(s) 140 for further processing to detect cortical activity indicative of the need for cortical stimulation or cortical inhibition or stimulation of some cortical regions and inhibition of other cortical regions.
  • such data processing methods and algorithms are disclosed in detail in published international application WO 2018/109715 and may be implemented herein for data analysis and processing by suitable programming of the processor/controller(s) 140.
  • the digitized signals or the analog signals are telemetrically transmitted to an external receiver (or transceiver) and are communicated (preferably wirelessly) to one or more processors disposed outside the body of the patient or person (such as, for example, directly to the pod 19 or the pod 29) and from the pod 19 to the smartphone 11, or the laptop 15, or to any other hand held or wearable or mobile computational/communicating device which may have sufficient processing power to perform the required signal analysis and data processing.
  • Such more powerful processing devices may detect that the cortex requires stimulation/inhibition and may wirelessly transmit control signals to the telemetry module 138.
  • Such control signals may be communicated to the processor/controller(s) 140 and may result in the processor/controller(s) 140 initiating cortical target stimulation and/or inhibition, as is disclosed in detail hereinafter.
  • a multi-channel voltage (or current) pulse generator module 170 of the implant 28 is suitably connected to the processor/controller(s) 140 for controlling the operation thereof.
  • the multi-channel voltage (or current) pulse generator module 170 may include individually and selectively operable controllable variable voltage (or current) pulse generators 90 that are operatively connected to a second electrode selecting module 124.
  • Each of the stimulating electrodes 30A, 30B, 30C and 30D is switchably electrically connectable to one of the four voltage (or current) pulse generators 90. It is noted that the number of four pulse generators is not obligatory and may depend, inter alia, on the number of the stimulating electrodes included in the implant.
  • An auxiliary electrode 30F and any other auxiliary electrodes included in the device may be electrically connected to the multi-channel voltage (or current) pulse generator module 170.
  • the auxiliary electrode 3 OF may be held at a voltage of zero volts (0V) and may be operating as a current sink or a current source or a current sink/source, depending on the polarity of the voltage applied to each of the stimulating electrodes 30A, 30B, 30C and 30D.
  • a square voltage pulse of +5V may be applied to the stimulating electrode 30A
  • a square voltage pulse of +2.5V may be applied to the stimulating electrode 30B
  • a square voltage pulse of -2.5V may be applied to the stimulating electrode 30B
  • a voltage of 0V may be applied to the stimulating electrode 30D.
  • a square voltage pulse of -5V may be applied to the stimulating electrode 30A, while a square voltage pulse of +8V may be applied to the stimulating electrode 30B, a square voltage pulse of +4.5V may be applied to the stimulating electrode 30B and a square voltage pulse of -4.5V may be applied to the stimulating electrode 30D.
  • a negative pulse may be added after a positive pulse, the positive pulse (and vice versa for negative pulses), such that the duration of the positive pulse multiplied by the positive voltage amplitude equals the duration of the negative pulse multiplied by the negative voltage amplitude.
  • any combination of voltage (or current) pulses with various different polarities and various different amplitudes may be applied to the stimulating electrodes 30A, 30B, 30C and 30D.
  • Each different applied voltage combinations may result in a current flow having a specific three-dimensional (3D) shape and current density map.
  • the multi-channel voltage pulse generator module 170 may be used to deliver voltage pulses to the stimulating electrodes 3OA-3OD, in some embodiments of the implant 28, the multi-channel voltage pulse generator module 170 may be replaced by a multichannel voltage pulse generator (not shown in FIG. 3).
  • a multichannel voltage pulse generator may actually operate more satisfactorily in situations where the stimulating electrode impedance may change over time after implantation of the implant 28 due to changes in electrode surface properties and also due to changes in the impedance of the tissues underlying the stimulating electrodes.
  • the use of constant current pulses by such a multi-channel voltage pulse generator may therefore be more effective, in long term implantation, for achieving long term stability of the desired current density distribution in the tissues underlying the stimulating electrodes 30A, 30B, 30C and 30D.
  • the stimulating electrodes 3OA-3OD may be grouped into channels, where a channel may include one or more electrodes, and all permutations and combinations of the stimulating electrodes 30A, 30B, 30C and 30D may be possible.
  • a stimulating channel may include one stimulating electrode or two stimulating electrodes or three stimulating electrodes or four stimulating electrodes. More than one stimulating channel may be used in a therapy session.
  • a first stimulation channel may include the single electrode 30A while a second stimulation channel may include the two stimulation electrodes 30C and 30B (in this non-limiting example the electrode 30B may not be used for stimulation.
  • two stimulation channels may be used each including two stimulating electrodes (such as, for example, electrodes 30A and 30B are included in a first stimulation channel and electrodes 30C and 30D are included in a second stimulation channel).
  • the stimulating electrodes 3OA-3OD may be arranged in different positions on the surface of the implant, different combinations of stimulating electrodes in a channel may result in different current density distributions, depending inter alia, on the arrangement or configuration of the electrodes on the surface of the implant.
  • a stimulation channel including the two electrodes 30B and 30C may produce a different current density distribution in the underlying brain tissue than a stimulation channel including the two stimulating electrodes 30A and 30C.
  • an implant may have a different number (smaller or larger) of stimulating electrodes than the four stimulating electrodes 3OA-3OD, the number of possible stimulating electrodes in a stimulating channel may vary accordingly.
  • stimulation channels may be used for stimulating depending, inter alia, on the total number of stimulating electrodes available in the implant and the total number of separate current or voltage pulse generators available in the implant.
  • the configuration of the stimulating electrodes in a stimulating channel and the exact voltage amplitude pulse shape, pulse polarity applied to each stimulating electrode within each of the stimulation channel may be used for current steering for more precise stimulation of a desired cortical stimulation target, as disclosed in detail in international publication No. WO 2021/144730.
  • a sensing channel may include any desired combination or configuration of the sensing electrodes 25A-25D as described above for the stimulating channel(s). If the embodiment of the implant includes more than four sensing electrodes, a sensing channel may include any combination and/or configuration of the sensing electrodes available in the implant.
  • stimulation waveforms described herein refer to pulsatile shapes
  • non-pulsatile therapeutic electrical signal shapes may be used to activate or inhibit neural activity.
  • sinusoids, exponentials, and gaussian wavelets could be assembled to create electrical signal patterns that provide advantages in activating or inhibiting specific cell types, minimizing power consumption, and minimizing undesirable current distributions on the electrode surface that may lead to electrode degradation.
  • the bi-directional data link between the implant and the energizing pod is asymmetric, providing higher data rates in one direction of communication than the other direction. For example, streaming neural signals out of the implant will often require a higher data rate than periodically transferring stimulation parameters to the implant.
  • the bi-directional link is symmetric, providing equal data rates in both directions of communication.
  • a Bluetooth radio may be used to establish a symmetric bi-directional link between the implant and the energizing pod.
  • the transfer of data is implemented through any combination of inductive, resonant inductive, radio-frequency, volume conductive, optical, or ultrasonic couplings between the implant and external pod.
  • FIG. 4 is a schematic block diagram illustrating the components of an exemplary embodiment of an interactive wireless energizing pod useable in the systems of the present application.
  • the wireless energizing Pod 19 may include a processor/controller 8, and a memory unit 6 suitably coupled to the processor/controller 8 or integrated within the processor/controller 8.
  • the energizing Pod 19 may also include a wireless power transmitter/data transceiver module 22, a user interface 32, a permanent magnet 24 (optional), a transceiver 20, a transceiver 18 (optional) and a power source 4.
  • the power source 4 may be any suitable type of electrical power source, such as any known type of rechargeable battery (such as, for example, a lithium-ion rechargeable battery a lithium polymer rechargeable battery), a super-capacitor, or any other type of suitable rechargeable electrical power source.
  • any known type of rechargeable battery such as, for example, a lithium-ion rechargeable battery a lithium polymer rechargeable battery
  • a super-capacitor such as, for example, a lithium-ion rechargeable battery a lithium polymer rechargeable battery
  • any other type of suitable rechargeable electrical power source such as any known type of rechargeable battery (such as, for example, a lithium-ion rechargeable battery a lithium polymer rechargeable battery), a super-capacitor, or any other type of suitable rechargeable electrical power source.
  • the optional transceiver 18 may be or may include a power receiver configured to wirelessly receive power from the pod charger 17, for charging the power source 4, such as, for example, by using an inductance coil (not shown for the sake of clarity of illustration) wirelessly couplable to a corresponding inductance coil (not shown in detail) disposed within the pod charger 17.
  • the transceiver 18 is not included in the energizing pod and the power source 4 may be charged by suitable electrical contacts (such as, for example the two electrically conducting contacts 37 A and 37B of the energizing pod 39 of FIG. 9 hereinafter that are configured to be in electrical contact with the two spring-loaded pins 58 A and 58B of FIG. 10 hereinafter.
  • the (optional) permanent magnet 24 may be any type of permanent magnet (such as, for example, a neodymium- Iron-boron based permanent magnet), but other permanent magnet types may also be used.
  • the permanent magnet 24 may be attached to or enclosed within the energizing pod 19 or 29 and may be used to enable the attachment (and possibly the alignment) of the pod 19 to the scalp of the patient 115 using the magnetic attracting force of another permanent magnet (not shown) disposed within or on the implant 10 (the use of such magnets is disclosed in detail in published international patent applications WO/2019/130248, WO/2019/244099, WO/2020/161555 and WO/2021/144730).
  • the use of magnetic attraction to hold the energizing pod is not the subject of the present application and is therefore not disclosed in detail hereinafter.
  • the use of such permanent magnets is not obligatory and other methods for attaching the pod 19 to the scalp region overlying the implant 10 may be used such as, for example a headband, or a strap (not shown) to attach the energizing pod 19 to the scalp, a wearable hat or head cover (not shown) to which the energizing pod 19 may be detachably attached, or any other type of suitable attaching method.
  • the power source 4 may be suitably electrically connected to the processor/controller 8, the transceiver 18, the transceiver 20, the memory 6, and the user interface 32 for providing electrical power thereto.
  • the connections of the power source 4 to the above components are not shown in FIG. 4 for the sake of clarity of illustration.
  • the wireless power transmitter/data transceiver module 22 includes an inductance coil 23 that may be operated for transmitting power to the induction coil 55 of the implant 10 or of the power harvesting module 145 of the implant 28.
  • the transceiver 20 may be used for bidirectional communication with the smartphone 11. If the smartphone 11 is used for receiving input from patient 115 regarding the selected values of the user modifiable therapy parameters, the smartphone 11 may wirelessly transmit the ICF to the pod 19 (or 29) using the transceiver 20. The transmitting may be performed using any transmission protocol such as, for example, Bluetooth, Wi-Fi, a cellular packet protocol or any other suitable transmission protocol. The ICF may then be stored in the memory 6 by the processor/controller 8 for later transmission to the implant 10 (or the implant 28).
  • the user interface 32 may include button(s) 34 that may be pressed or touched by the patient 115, the user interface 32 may also include one or more light source(s) 36 which may be used to provide various visual signals serving as cues to the patient 115.
  • the light source(s) 36 may be implemented as one or more light emitting diodes (LED).
  • LED light emitting diodes
  • other types of light sources such as, for example, electroluminescent light sources, or any other type of light sources having a low operating voltage and a low current consumption.
  • the patient 115 may press the button (not shown) for a long press (four seconds or more) to start a parameter value input session which may result in one of the light source(s) 36 to exhibit a blinking orange light to indicate the starting of the input session, the patient 115 may then press the button three short presses to input an stimulus amplitude level of three out of five selectable amplitude values (or the patient 115 may use five short button presses to input the maximum allowable stimulus amplitude, etc.).
  • a therapy parameter such as, for example, the stimulating pulse amplitude
  • the patient 115 may press the button for a long press again to input the selected value, this may result in a green LED light of the Light source(s) 36 blinking three times to indicate that the input has been received.
  • the button(s) 34 and light source(s) 36 the patient 115 may be able to enter (input) his parameter value selections of one or more patient modifiable parameter values into the pod 19.
  • the button (or buttons) 34 may also be used for activating the pod 19 for starting a therapeutic session.
  • the pod 19 may be activated by the patient 115 by pressing the button 34 with three consecutive long presses which may cause a red LED of the Light source(s) 36 to blink intermittently indicating that the patient 115 needs to put the pod 19 on the location of the head 3 above the implant 10 (or the implant 28) to start a therapeutic session.
  • discreet auditory signals may be provided to the user via bone conduction, where small vibrations emitted by a vibrator included in the implant 10 or in the energizing pod(s) 19, 29 and 39 are conducted via the calvarial bone to the user’s ear.
  • This type of feedback is preferred for discreet use and is well-suited for implants that are embedded in or near bone.
  • the speech analysis software may be operating on a processor of the smartphone 11 or the laptop 15 or any other device included in the local subsystem 14 instead of operating on the processor/controller 8 of the pod 19.
  • the device performing the speech analysis may also send some data over the internet for performing the speech analysis using cloud processing.
  • the decoded speech content may be transmitted wirelessly back to the pod 19 and used by the pod 19 to update the DPF and/or to be used as command signals for operating the pod 19.
  • the analyzed words “start therapy” may be used to send to the pod 19 a signal causing the pod 19 to initiate a therapy session.
  • the taps may be sensed by the IMU 42 and the signals from the IMU 42 are sent to the processor/controller 8 for processing.
  • the processor controller analyzes the sensed signals and determines the number of taps (for example by detecting the number of voltage threshold crossings in the IMU signals, as is known in the art), the processor/controller 8 may then save the value “3” in the appropriate field in the DPF representing the value of the stimulating pulse amplitude.
  • the wireless link to any combination of devices included in the local subsystem 14 may be implemented with a single transceiver such that data is exchanged in a timedivision multiplexed protocol. In other embodiments the wireless link to any combination of devices included in the local subsystem 14 may be implemented with a combination of multiple transceivers such that data is exchanged between multiple devices in parallel.
  • a Zigbee radio may communicate between the energizing pod 19 and other energizing pods while at the same time a Wi-Fi radio may communicate between the energizing pod and a cloud computing service (or with the main server(s) 12 and the clinician workstation 13). This implementation has the advantages of optimally sizing data rates (and resulting power consumption) to the specific type of communication needed between different classes of devices and also allowing communication between all devices to proceed simultaneously and without interruption.
  • This implantation method may increase the signal to noise ratio (S/N) of the cortical signals recorded by the recording electrodes (such as, for example, the electrodes 25A-25D of FIG. 3) and may also reduce the amount of current that needs to be applied by the stimulating electrodes (such as, for example, the electrodes 3OA-3OD of FIG. 3) in order to cross the excitation threshold of at least some cortical neurons underlying the stimulating electrodes 3OA-3OD.
  • the recording electrodes 25A-25D and the stimulating electrodes 3OA-3OD may be disposed on the bottom surface 52A of the implant 52 and on the bottom surface 62A of the implant 62.
  • the implant 62 may be firmly attached to the calvarial bone 44 by two bone screws 54 and 56, as is illustrated in FIG. 6.
  • the implant may be implanted by making an incision in the scalp of the patient and inserting the implant between the scalp and the outer surface of the calvarial bone, and closing the incision.
  • Such an implantation method may have the advantage of greater simplicity and reduced invasiveness as it does not involve any bone drilling or removing a portion of the calvarial bone.
  • FIG. 31 is a part cross-sectional diagram illustrating another possible implantation method of the implants usable in the systems of the present application.
  • the Implant 72 may include an implant housing 73 having two attachment flanges 73 A and 73B.
  • the attachment flange 73 A has a through hole 73C formed therein and the attachment flange 73B has a through hole 73D formed therein.
  • Bone screws 54 and 56 may be used to firmly attach the implant 72 to the calvarial bone 44.
  • the implant 72 may also include an electronics module 76, an induction coil 74 a permanent magnet 75 and stimulating electrodes 77A and 77B. It is noted that only two stimulating electrodes 77A and 77B may be seen in the cross- sectional view of Fig. 31. However, the implant 72 may include any suitable number of stimulating electrodes.
  • the electronics module 76 may include the power harvesting module 145, the telemetry module 138, the processor/controller 140, the memory unit(s) 142, the digitizing/multiplexing module 139, the multi-channer voltage pulse generating module 170 and any other of the components shown in detail in FIG. 3. It is noted that no details of such components are shown in detail in FIG. 31 for the sake of clarity of illustration.
  • the stimulating electrodes 77A and 77B may be used for delivering electrical signals to the cortex 50 underlying the calvarial bone 44 within electrical therapy sessions as disclosed hereinabove.
  • the stimulating electrodes 77A and 77B may be electrically connected to the electronics module 76 by electrically conducting wires 78 and 79, respectively, to deliver electrical signals from a suitable signal generator (not shown in detail in FIG. 31) included in the electronics module 76 (However, see FIG. 3).
  • the implant 72 may also (optionally) include sensing electrodes (not seen in the cross-sectional view of FIG. 31) for sensing electrical signals generated within the regions of the cortex 50 underlying the implant 72.
  • the implant 72 may be implanted between the outer surface 44 A of the calvarial bone 44 and the scalp 53 of the patient as illustrated in FIG. 31. After implantation, the energizing pod 39 may be placed on the scalp 53 of the patient. A detailed explanation of the components and operation of the energizing pod 39 are provided hereinabove with respect to FIGS 8-9.
  • FIG. 7 is a schematic block diagram, illustrating the components of a system for delivering therapeutic treatment to multiple patients supervised by multiple clinicians, in accordance with an embodiment of therapeutic systems of the present application.
  • the local subsystem 14A is in communication with the implant 10A that is implanted in the calvarial bone of the patient 115A
  • the local subsystem 14B is in communication with the implant 10B that is implanted in the calvarial bone of the patient 115B
  • the main servers 12A-12M may be located in a server farm or in the headquarters of the company that provides the implants 10A- 10K and various services and/or software3 to subscribing clinicians having clinician workstations.
  • FIG. 8 is a schematic isometric view of a magnetic wireless energizing pod, in accordance with an embodiment of the wireless energizing pods of the present application.
  • FIG. 9 is a schematic cross-sectional view of the energizing pod of FIG. 9, taken along the lines IX-IX.
  • the energizing pod 39 may include a housing 26.
  • the housing 26 is made from an electrically insulating and biocompatible material, such as, for example an injection-molded plastic.
  • the housing 26 in order to optimally fit to a curved surface of the body (such as, for example, the head 3 of the patient 115), the housing 26 may be curved, concave, or flexible.
  • the energizing pod has a low profile such that it is not easily seen on the surface of the body.
  • the pod 17 may also include a speaker 38 facing suitable holes 43 perforating the housing 26.
  • the holes 43 allow sound emitted from the speaker 38 to be heard outside the pod 17,
  • the pod 17 may also include a multi-function button 67 for user inputs (such as, for example, turning the device on or off, and for activating light sources 65 and 66 that are included in the energizing pod 17 and may function as charge level indicators.
  • the light sources 65 and 66 may be implemented as linear LED arrays each including several LEDs.
  • the energizing pod 39 may include the power source 4 (of FIG. 4) for providing electrical power the energizing pod 39.
  • the power source 4 may be implemented as a rechargeable battery, a primary battery a capacitor, a super capacitor, or other suitable energy storage device.
  • the power source 4 is a re-chargeable power source, in such an embodiment, the energizing pod 17 may include two electrically conducting contacts 37A and 37B electrically connected to the power source 4 for recharging the internal power source 4.
  • the power source 4 is a primary electrochemical cell or battery, the power source 4 may be removed from the energizing pod 17 and replaced.
  • the energizing pod 39 may include the power transmitting inductance coil 23 (of FIG. 4) that may be used to implement an inductive power link.
  • the nominal diameter for the inductance coil 23 coil may be about two-three centimeters, which is sufficient to transmit power to an implant with a receiving inductance coil 55 (of FIGS. 3 and 4) having a diameter of approximately one and a half to two centimeters, through approximately 1-2 cm of tissue.
  • the specific diameters, number of turns, and electrical properties of the inductance coils 23 and 55 may vary according to the specific application and may be tuned for optimal power transfer efficiency.
  • a ferrite element (not shown) may be included within the implant or the wireless energizing pod to achieve optimal power transfer by shaping the magnetic field.
  • the wireless energizing pod 39 may include a magnet 41 for magnetically coupling the wireless energizing pod 39 to the magnet 5 disposed in the implant 28 or to a magnet (not shown) disposed within the implant 10 (of FIG. 1).
  • the magnet 5 may be similar in structure and magnetic properties to the magnet 24 (of FIG. 4)
  • the energizing pods 19 and 39 may include an optical sensor (not shown), or a camera (not shown), to collect patient input through gestures, facial expressions, or environmental information.
  • Feedback to the patient 115 may be implemented via the light sources 35 or 36 that may light up to indicate, for example, system status, battery power, or confirmation of user input.
  • Feedback signals may also be implemented in some embodiments, by using the speaker 38 or a vibrator (not shown) to emit sounds or vibrations, respectively, that can be heard or felt by the patient 115. In some applications, discreet use of the system may be important to the patient 115, which will make feedback via the speaker 38 undesirable.
  • discreet auditory/vibratory signals may be provided to the patient 115 via bone conduction, where small vibrations in the implant 10 are conducted via the surrounding bone to the inner ear of the patient 115.
  • This type of feedback is preferred for discreet use and is well suited for implants that are embedded in or near a bone of the patient 115.
  • the pod 39 may include a charging port 68, that may be implemented as a USB port (such as, for example, a USB A port, a USB B port, A USB C port and the like).
  • the charging port 68 may be useful for charging the energizing pods of the present application without using the pod charger 17, if necessary, as disclosed in detail hereinafter.
  • the charging port 68 may also be used to transfer data from the energizing pods 19 and 39 to the smartphone 11 or the laptop 15 or to any other component included in the local subsystem 14, as is disclosed in detail hereinafter.
  • FIG. 10 is an isometric view illustrating in more detail the energizing pod charger 17 of FIG. 2.
  • the Pod charger 17 may be any suitable charger that may charge one or more energizing pods (such as, for example the pod 19 and the pod 29 of FIG. 2).
  • the pod charger 17 may include a housing 26 made from any suitable, preferably non-electrically conducting, material such as, for example, engineering plastic.
  • a power source (not shown in FIG. 10) is disposed within the housing 68.
  • the power source may be any electrical power source, such as, for example, a rechargeable electrochemical cell, or a capacitor, or a super-capacitor.
  • the charger power source is a rechargeable lithium-ion rechargeable battery or lithium polymer rechargeable battery.
  • the energizing pod charger 17 may include a charging port 58, that may be used for electrically connecting the pod charger 17 to a DC power supply (not shown).
  • the charging port 58 may be implemented as a USB port and the DC power supply may be a standard five-volt (5 V) power supply.
  • the pod energizing charger 17 may include two docking mechanisms 63 and 64 implemented as two cylindrical recesses.
  • the docking mechanism 63 may have two spring-loaded pins 58A and 58B that match the charging contacts 37A and 37B of the energizing pod 39 (of FIG. 8).
  • the docking mechanism 64 may have two spring-loaded pins 58C and 58D that match the charging contacts 37A and 37B of the energizing pod 39.
  • the spring-loaded pins 58 A and 58B make contact with the contact pads 37A and 37B and recharging of the power source 4 of the energizing pod 39 by the power source included in the pod charger 17.
  • the pod charger 17 may include a multifunction button 67, and two charging indicator light sources 65 and 66.
  • the charging indicator lights 65 and 66 may be implemented as linear LED arrays, as is known in the art.
  • the pod charger 17 may include a lid 57 that may cover the tow docking mechanisms 63 and 64.
  • the pod charger 17 may include standard charging regulating circuitry (not shown) disposed within the housing 68 and electrically connected between the recharging port 58 and the power source (not shown) of the pod charger 17, as is known in the art.
  • the pod charger 17 may also include a speaker or buzzer (not shown in the isometric view of FIG. 10) disposed opposite speaker holes 59 passing through the housing 68.
  • the speaker may be used to provide auditory user feedback.
  • the speaker may beep once indicating proper placement and the beginning of recharging of the pod(s).
  • the speaker (not shown) of the pod charger 17 may beep twice and the indicator light source(s) 65 or 66 or both 65 and 66 may indicated the charge in the pod(s) by lighting a number of LEDs proportional to the percent of the total full charge of the power source 4 of the pod(s).
  • the construction and operation of the pod charge 17 is not the subject matter of the present application and is therefore not described in detail hereinafter.
  • the construction and operation of such chargers is known in the art of chargers for wireless earphones.
  • some embodiments may send a notification to the clinician’s workstation 13 that the login failed and allows the user to repeat entering the user’s credentials a fixed number of times (for example, three more times) after which if all logins failed the session is terminated after logging of the failed login attempts by the main server(s) 12.
  • the device requesting the download of the DPF may be any of the devices included in the local subsystem 14, such as, for example, the smartphone 11, the laptop 15 (or a tablet or phablet used by the patient 115), the smartwatch 117 (assuming the smartwatch 117 includes a suitable application operating thereon and is able to communicate with the energizing pod 19 and/or 29) and, in some embodiments, the energizing pod 19 or 29.
  • the clinician notification log may be accessed by the clinician using the clinician’s workstation 13. For example, when the clinician initiates a new session of working on the clinician’s workstation 13, all the new notifications for all the patients treated by the specific clinician may be actively pushed by the main server(s) 12 to the clinician’s workstation 13 and may be automatically displayed to the clinician. In this way the clinician is kept updated of the status of patient’s DPF request for all his patients. These notifications may be useful for monitoring patient’s conformance to scheduled treatments.
  • the program (or subroutine) illustrated in FIGS. 14A-14B enables the main server(s) 12 database to be periodically up to date regarding the DPF records for all patients.
  • FIG. 15 is a schematic flow diagram illustrating a method for time synchronization between the main server and an energizing pod, in accordance with an embodiment of the methods of the present application.
  • the energizing pods of the present application (such as, for example, the pods 19, 29 and 39) need to keep track of time as they may need to record the time of performing therapy sessions and/or may need to record or log the timing of other events occurring during the operation of the energizing pods.
  • the processor/controller 8 of the energizing pod 19 may include timing electrical circuitry (not shown in FIG.
  • the requesting of a time synchronization by an energizing pod may be automatically initiated at fixed or present time interval.
  • the energizing pod’s software program may initiate such a request every three days or every seven days or every any other suitable time period based on the internal timing circuitry of the energizing pod.
  • the pod’s software program initiates a request for date/time.
  • the pod’s software program may be programmed to issue a date/time synchronization request each time the pod is placed on the patient’s scalp in preparation for a therapeutic session.
  • duration of the time interval separating such automatically initiated pod date/time synchronization requests may depend, inter alia, on the accuracy of the internal clock circuitry of the pod and on the desired accuracy of time recording for event logging by the main server(s) 12.
  • FIG. 16 is a schematic flow diagram illustrating the steps of a method for creating a new DPF by the main server(s), in accordance with an embodiment of the methods of the present application.
  • the main server(s) 12 receives from a trusted clinician workstation 13 over a secured link a new DPF for a registered patient (step 248).
  • the main server checks whether the DPF is in conformance and safe (step 250). The check of step 250 is based on a comparison of the relevant therapy parameters (and/or the specified parameter value ranges of the patient modifiable parameters) with preset safe values and ranges that are stored in the memory of the main server(s) 12.
  • the program notifies the clinician of the non-conformance or safety issue, recommends (if possible) corrective action to the clinician (step 252) and transfers control to step 248.
  • the recommendation for corrective action may be implemented as flagging or indicating the nonconforming or unsafe parameter value (s) entered into the DPF by the clinician and prompting the clinician to enter a new parameter value(s) or parameter value ranges that conform with the main server(s) allowed values and value ranges and is safe.
  • the program creates a DPF using an encryption key, stores the encrypted DPF and transmits a notification to the clinician’s workstation that a new DPF is available (step) 254).
  • the program then adds a notification to the patient’s notification log that a new DPF is available (step 256) and terminates.
  • the smartphone 11 or the other devices on which the patient application is installed may be also used for obtaining ecological momentary mood assessment (EMA) data indicative of (or correlated with) the mood of the patient’s 115 and/or the collected data representing objectively quantified parameters of use of the smartphone 11 by the patient 115and for wirelessly communicating with the main server(s) 12.
  • the main server(s) 12 may store and process the EMA data and/or the collected data representing objectively quantified parameters of use of the smartphone 11 by the patient 115.
  • the secure login subroutine of FIG. 17 starts by presenting a login screen on a device such as, for example, the smartphone 11, or the laptop 15 or in some embodiments the smartwatch 117 (step 258).
  • the subroutine reads the user credentials (step 260).
  • the subroutine checks whether the read credentials (a two-factor authentication may be used, such as, for example a user name and/or a password) match those of a trusted user (step 262). If the credentials read do not match those of a trusted user, the subroutine may return control to Step 258 to present a login screen again (possibly with an indication to the patient that the credentials do not match or that there is an error in the user’s name or in the password).
  • the subroutine establishes a secure link with the main server(s) 12 (step 264).
  • the subroutine may then send updates to the main server(s) 12 (step 266).
  • the updates may include the date/time of the last activation of the implant (for sensing and/or stimulation), patient requests (for example, a patient may request a DPF that prescribes a more intense stimulation, or a longer session time, and/or additional updates, such as, for example, text message from the user, information about the device activation times, sense data, failure logs (i.e. the user tried to activate and failed for some reason), locked states (i.e. the device is locked for some reason).
  • the subroutine receives updates and/or patient notifications (from the patient notifications log of the main server(s) 13, presents the updates and/or notifications to the patient (step 268) and terminates.
  • FIG. 18 is a schematic flow diagram illustrating a method for connecting and data exchange between a patient application operating on one or more of the devices included in the local subsystem 14 and a pod, in accordance with an embodiment of the patient application of the present application.
  • the method may be implemented as a subroutine or subprogram of a patient application operating on one or more devices included in the local subsystems 14 (of FIGS 1-2), and 14A-14K (of FIG. 7).
  • the method may be operating on the smartphone 11, and/or on the laptop 15 (or a tablet computer, or notebook or phablet used instead of the laptop 15), and/or on the smartwatch 117.
  • the patient application may be operating on the smartphone 11.
  • the subroutine starts by performing a secure login (step 270), a login screen may be presented on the smartphone display as disclosed in detail hereinabove. After successfully completing the login, the patient may be presented by an option menu and may choose to request a connection to an energizing pod.
  • the subroutine detects a user request to connect to a pod (step 272).
  • the subroutine may then search for available and approved energizing pods (step 274) and presents to the patient a screen with a list of available approved energizing pods (step 276).
  • the patient may select a desired available pod from the list.
  • the subroutine reads the pod selected by the patient (step 278).
  • the subroutine may then connect to the selected energizing pod over a secured link (step 280).
  • the subroutine queries the energizing pod for updates and/or notifications (step 282), and presents the notification on a screen (if there is a notification) (step 284).
  • the subroutine than checks whether the connected pod is in a locked state (step 286). If the connected pod is not in a locked state, the subroutine terminates. If the connected pod is in a locked state the subroutine checks whether an internet connection is available on the smartphone 11 (step 288).
  • the subroutine If an internet connection is not available to the smartphone 11, the subroutine notifies the patient that the pod is locked and prompts the patient to establish an internet connection (for example, by activating a Wi-Fi connection) (step 290). After an (optional) time delay, the subroutine transfers control to step 288. If an internet connection is available, the subroutine enables a secure connection between the pod and the main server(s) 12 which unlocks the pod (step 292), the subroutine then transfers control to step 286.
  • the subroutine starts by performing a secure login procedure (step 294) in which a login screen is presented on the screen of the smartphone 11, and the patient 115 may enter his credentials into the appropriate places in the login screen (for example, a user name and a password) (step 294).
  • the subroutine may present on the display of the smartphone 11 an operation selection screen to the patient.
  • the subroutine detects if the user selected the operation of downloading a new DPF (step 295) and requests a download of a new DPF from the main server(s) 12 over a secure link (step 296).
  • the subroutine receives and stores a new PDF on the smartphone 11 (step 297), stores the new DPF in the memory of the smartphone 11 (step 298), and terminates.
  • the patient application is installed and operates on the smartphone 11, in other embodiments, the patient application may be installed on the laptop 15 or on a tablet, phablet or notebook substituting the laptop 15.
  • the subroutine checks whether one or more DPFs are stored in the memory of the smartphone 11 (step 304). If there are no DPFs stored in the memory of the smartphone 11, the program terminates. If there are one or more DPFs stored in the memory of the smartphone 11, the subroutine fetches the first DPF data from memory (step 305). The subroutine then checks if the current date/time exceeds the DPF’s expiration date/time (step 306).
  • the patient application is installed and operates on the smartphone 11, in other embodiments, the patient application may be installed on the laptop 15 or on a tablet, phablet or notebook substituting the laptop 15. Additionally, a version of such a patient application may also be loaded and operated on the energizing pods of the present application to enable the patient to activate a therapy session and modify the patient modifiable therapy parameters in the absence of the smartphone 11 (or of the laptop 15 or the tablet, notebook or phablet of the local subsystem 14).
  • the subroutine starts by performing a patient login on the smartphone 11 (or on the pod 19 or 29, if the smartphone 11 is not available), as is disclosed hereinabove (step 310).
  • the subroutine presents an operation selection screen to the patient 115. If the user (such as, for example, the patient 115) requested a screen for modifying the values of patient modifiable therapy parameters (by inputting a suitable selection from a menu screen), the subroutine detects the user input (step 312) and presents a parameter modifying screen to the patient 115 (step 313).
  • the patient application of the energizing pod 19 or 29 may use (in steps 310, 313, 316, 320, below) any of the components of the user interface 32 to provide the user with interactive input/output means such as the display 44 (that may, optionally, be a touch- sensitive display, the light source(s) 36, the buttons 34 and/or the microphone 40 and the speaker 38).
  • the display 44 that may, optionally, be a touch- sensitive display, the light source(s) 36, the buttons 34 and/or the microphone 40 and the speaker 38.
  • the subroutine checks whether the patient has entered parameter values (using the parameter modifying screen presented in step 313) within a preset time period (step 314). If the patient 115 has not entered parameter values within the preset time period, the subroutine uses the default parameter values of the DPF (step 315) and transfers control to step 322. If the patient 115 has entered parameter values within the preset time period, the subroutine reads the entered parameters (step 316). The subroutine checks whether the entered parameter values are within the valid value ranges (step 318). If the entered parameter values are not within the valid value ranges, the subroutine notifies the patient that the entered parameter(s) values are invalid and provides an explanation why the parameter(s) values are invalid (step 320), and returns control to step 314.
  • the parameter modifying screen may allow patient control over single stimulation parameters (as described in detail hereinabove and illustrated in FIG. 21), this is not obligatory.
  • the subroutine may bundle multiple parameters into a single displayable parameter.
  • the frequency, amplitude, and duration parameters in the DPF may be bundled and displayed as a single parameter represented as a parameter named “stimulation level” (or any other desired name) that may be displayed as a bundled parameter on the parameter modifying screen of the smartphone 11 (or on any other device being used to enable the patient 115 to modify stimulation parameters).
  • the patient 115 may enter the desired values for one or more patient modifiable therapy parameters.
  • the smartphone 11 may display the selection options as “HIGH”, “MEDIUM” and “LOW”, allowing the patient 115 to choose between these options using selection buttons, in which case the application will calculate the ICF parameter value using the minimum, default and maximum values for that parameter from the DPF. If the application bundled several parameters into a single displayed parameter, the patient selection may apply to all parameters included in the parameter bundle.
  • the application operating on the smartphone 11 may modify all three parameters setting the pulse frequency, the pulse amplitude and the pulse duration to the minimum values of the DPF.
  • a parameter bundle may include the stimulating pulse duration, the stimulating pulse amplitude and the number of pulses in a pulse train.
  • the parameter bundle may include the stimulating pulse amplitude and the inter pulse interval.
  • a bundled parameter may include any desired combination of single stimulation parameters.
  • bundling decisions may be performed by the clinician (or by a suitably trained Al program) after implantation of the implant in each individual patient based on testing (during a testing time period) the effects of varying each stimulation parameter alone and/or in selected parameter combinations.
  • Such parameter bundling may be based on the experimental data obtained in each individual patient during such testing time period to determine which stimulation parameters may be bundled to result in a more effective stimulation.
  • FIGS. 22A-22B are schematic flow diagrams illustrating a method (software subroutine) for using a patient application to enable the patient to set or modify the value of one or more patient modifiable therapy parameters including single modifiable parameters and/or multiple bundled parameters included in a DPF, in accordance with an embodiment of the methods of the present application;
  • the subroutine starts by the patient performing a secure login procedure (step 600).
  • the subroutine presents an operation selection screen to the patient 115. If the patient 115 inputted a selection of modifying values of patient modifiable therapy parameters, the subroutine detects the selection (step 602) and presents a parameter modifying screen to the patient 115 (step 604).
  • the preset time period may vary between 10-60 seconds but other time values outside the above indicated range may also be used, depending, inter alia, on the patient’s condition, severity of patient’s depressive symptoms, patient’s age, experimentally determined patient’s average response time, type and dose of any medication prescribed to the patient and other considerations.
  • the subroutine then checks if the parameter(s) value(s) are within the valid value ranges (step 618). If the entered parameter values are not within the valid value ranges, the subroutine notifies the patient that the entered parameter(s) values are invalid, provides an explanation why the parameter(s) values are invalid (step 620) and returns control to step 604. If all the patient entered parameter values are within the valid ranges, the subroutine generates an implant control data file (ICF) based on the parameter values entered by the patient 115 and the clinician set parameter values provided in the DPF (step 622), stores the ICF on the smartphone 11 (step 624) and terminates.
  • ICF implant control data file
  • step 624 should read “store ICF on pod”.
  • the patient application is operated on any other device included in the local subsystem 14 the ICF will be stored on the respective device being used (such as, for example, the laptop 15, the smartwatch 117, a tablet (not shown), a phablet (not shown) or any other device included in the local subsystem 14.
  • the subroutine repeats all the steps included within the dashed line 603, until all the patient modifiable parameters have been assigned values by the patient 115 or are assigned default values if the patient 115 has not selected parameter values.
  • the stimulation efficacy may not necessarily be a linear function of the stimulating pulse frequency beyond a certain limited range of frequencies. Therefore, there may be cases in which a “HIGH” selection of a specific single stimulation parameter by the patient 115 may actually correspond with a lower numerical value of the parameter while a “LOW” selection of the parameter may correspond with a higher numerical value of the same stimulation parameter.
  • Such non-monotonous and/or nonlinear behavior may preferably be investigated during the test time period for each individual patient. After experimentally determining the relationship between a stimulation parameter value and the resulting stimulation efficacy, it may be possible to address such behavior by either limiting the valid range for a specific stimulation parameter to a range within which the dependence of stimulation efficacy on the parameter value behaves monotonously (or in certain cases linearly or close to linearly, if possible). It may also be possible to use a “reversed” value range in which the minimum numerical value stored in the parameter value field results in a higher stimulation efficacy and the maximum numerical value stored in the parameter value field results in a lower stimulation efficacy.
  • the selection by the patient 115 of a “HIGH” value will result in a selection of the minimum parameter value for storing in the ICF and a selection of a “LOW” value by the patient 115 will result in a selection of maximum value for storing in the ICF.
  • the selection of “LOW” by the patient 115 may result in assignment of a maximum parameter value for some of the parameters included in the parameter bundle and the assignment of the minimum values for other parameters included in the parameter bundle. Any such combinations may be possible depending, inter alia, on the empirically determined behavior of the stimulation parameters determined in the testing time period for each individual patient. Moreover, in different individual patients, some parameters may behave differently in different patients.
  • FIGS. 23A-23B are schematic flow diagrams illustrating the steps of an exemplary method (and subroutine) included in the patient application and usable for initiating a therapy session, in accordance with an embodiment of the methods of the present application.
  • the patient application (including the subroutine) is installed and operates on the smartphone 11, in other embodiments, the patient application may be installed on the laptop 15 or on a tablet, phablet or notebook, substituting the laptop 15 or on the smartwatch 117.
  • the subroutine starts by connecting to an energizing pod (such as, for example, the pods 19 or 29 or 39).
  • the patient may need to perform a login procedure prior to performing the subroutine (for example, if the patient application needs to be activated or opened on the smartphone 11).
  • a login procedure (not shown in FIGS. 23A-23B) may be performed as disclosed in detail in steps 258-264 of FIG. 17.
  • the subroutine connects the smartphone 11 to the energizing pod (such as, for example, the pods 19 or 29 or 39) over a secure link (step 326).
  • the pod to which the smartphone 11 is connected in step 326 may be a pod that was selected by the method disclosed hereinabove and illustrated in FIG. 18 for selecting a pod to establish a connection with.
  • step 326 may include performing steps 270-292 of the method of FIG. 18 and then transferring control to step 328 of FIGS. 23A-23B.
  • step 328 of the subroutine may present to the patient a screen with selectable actions and the patient 115 may select the action of initiating a therapy session.
  • the subroutine detects that the patient’s input requested starting a therapy session (step 328).
  • the subroutine checks whether the energizing pod connected to the smartphone is communicatively connected to a registered implant such as, for example, the implant 10 or 28 (step 330). If the energizing pod is not connected to a registered implant, the subroutine prompts the patient to place the energizing pod on the patients head 3 over the implant (step 331) and returns control to step 330. If the energizing pod is connected to a registered implant the subroutine may present to the patient a screen showing the approved (valid) DPFs available for use (step 332).
  • the subroutine After the patient 115 has selected a desired DPF (for example, by touching an appropriate selection button displayed on the therapy selection screen displayed on the smartphone 11) the subroutine detects the patient’s input indicating the desired DPF (step 333) and transfers control to step 334. It is noted that if only one type of DPF is currently available, steps 332 and 334 may be skipped by the subroutine. The subroutine may then check if the patient wishes to set the patient modifiable parameters (step 334). This check may be performed, for example, by presenting on the display of the smartphone I l a dialog box with the appropriate choice options (such as, for example, a “yes” and “no” virtual buttons).
  • the subroutine performs a parameter setting subroutine, generates an ICF and downloads the ICF to the energizing pod (step 335) and transfers control to step 341.
  • the parameter setting subroutine may be performed, for example, by steps 313, 314, 315, 316, 318 and 320 illustrated in FIG. 21. If the patient does not wish to set the values of the patient modifiable parameters, the subroutine checks whether there is more than one valid ICF stored in the memory of the energizing pod (step 336).
  • the subroutine If there is more than one valid ICF stored in the memory of the energizing pod, the subroutine presents to the patient a list of all valid ICFs available for use on the energizing pod (step 337), detects a patients input selecting a desired ICF (step 339) and transfers control to step 341.
  • the subroutine checks if there is a valid ICF loaded on the memory of the energizing pod (step 338). If there is no valid ICF loaded in the memory of the energizing pod, the subroutine uploads a valid ICF to the memory of the energizing pod (step 340) and transfers control to step 341. If there is a valid ICF loaded in the memory of the energizing pod, the subroutine transfers control to step 341.
  • the data collected by the energizing pod after receiving the command to initiate a therapy session and collect data in step 341 may include, inter alia, data representing neurophysiological cortical electrical signals sensed by the sensing electrodes 25A-25D of the implant 28, the date and time of the therapy session, the therapy log (received from the implant at the end of the therapy session), and therapy type, and may (optionally) include other data such as, for example, the patient’ s body temperature data, accelerometer data indicative of whether the patient is moving or lying down and luminosity data indicative of whether the patient is outside.
  • luminosity data may be obtained by the imaging sensor of the camera 33 of the energizing pod.
  • the energizing pod may include an (optional) photosensor (not shown in FIG. 4) that may provide luminosity data.
  • step 342 the subroutine collects the above indicated data from the energizing pod and logs the data in a patient log file (stored on the memory of the smartphone 11, and if the main server(s) 12 is online and connected to the smartphone 11, the subroutine updates the main server(s) 12 by uploading the patient log file to the main server(s) 12 and terminates. It is noted that if the main server(s) 12 is not online, the updating of the main server(s) 12 may be performed at a later time. For example, in step 266 of Fig. 17 hereinabove.
  • the collection of data by the smartphone 11 from the energizing pod may be performed after the therapy session ends.
  • the energizing pod may wirelessly collect some types of data from the implant “on the fly” during the therapy session.
  • the implant may wirelessly transmit sensed signal data to the energizing pod during the therapy session in order to periodically clear the memory of the implant for storing additional sensed signal data.
  • the memory capacity of the energizing pod may be significantly larger than the memory capacity of the implant as it is practically easier to have larger capacity memory in the energizing pod due of the significantly larger size.
  • FIG. 24 is a schematic flow diagram illustrating the steps of a method (subroutine) for updating digital prescription files (DPFs) on energizing pod(s) by a patient application, in accordance with the methods of the present application.
  • the patient application including the subroutine
  • the patient application may be installed on the laptop 15 or on a tablet, phablet or notebook substituting the laptop 15.
  • the method starts by connecting to one or more pods over a secure link (Step 346).
  • the subroutine may present the patient 115 with a selection screen for selecting several actions and the patient 115 may select to update DPF.
  • the subroutine detects the patient’s input (step 348) and queries the connected pod(s) for any preloaded DPFs (step 350).
  • the subroutine checks whether any preloaded DPFs are expired (step 352). If there are preloaded PDFs that are expired, the subroutine sends the pod(s) a command to delete any old expired DPF and log the event (step 354) and transfers control to step 356. If no preloaded PDFs are expired, the subroutine detects patient’s selection for a valid therapy file to be downloaded to pod(s) (step 356).
  • the subroutine checks whether the pod(s) contain an old DPF referencing the same digital prescription as the new DPF (step 358).
  • the subroutine sends a command to the relevant pod(s) to delete the old DPF, logs the event (step 360) and transfers control to step 362. If the pod(s) do not contain an old DPF referencing the same digital prescription as the new DPF, the subroutine transfers aa new DPF to the relevant pod(s) (step 362) and terminates.
  • the subroutine of FIG. 24 is directed to an embodiment where the ICFs downloaded to the energizing pod also include the entire data content of the DPF (for example, as disclosed in TABLE 2 hereinabove). Accordingly, the use of the term “DPFs” in FIG. 24 means “the DPFs included in the ICFs” and the term “DPF” means “the DPF stored in the ICF”.
  • the data of the DPF is not included in the ICF.
  • the subroutine of FIG. 24 is still valid by replacing the term “DPF” by the term “ICF” in steps 348, 354, 356, 358, 360 and 362, and by replacing the term “DPFs” by the term “ICFs” in steps 350 and 352.
  • the smartphone 11 may store more than one DPF at the same time.
  • the smartphone 11 may store simultaneously one or more DPFs for use in an anti-depression therapy session and one or more DPFs for use in a session for enhancing cognitive performance of the same patient using the same implant.
  • the energizing pod may store more than one ICF at the same time.
  • the energizing pod may store simultaneously one or more ICFs for use in an antidepression therapy session and one or more ICFs for use in a session for enhancing cognitive performance of the same patient using the same implant.
  • the energizing pod may include one ICF for low efficacy therapy and another ICF for high efficacy therapy.
  • the patient may have more than one implant (for example, a first implant implanted in a first position of the skull of the patient for treating depression and a second implant implanted in a second different position on the skull of the same patient for treating another type of disorder (for example, anxiety disorder, ADHD, PTSD, an eating disorder (such as, for example, obesity, bulimia, anorexia), Schizophrenia, OCD, or any other type of disorder).
  • the patient may also have an implant that may be used for cognitive enhancement and another implant for treating a neurological or neuropsychiatric disorder.
  • the smartphone 11 (or any one of the devices included in the local subsystem 14 of FIG. 1) may store more than one DPF at the same time.
  • the smartphone 11 may store in its’ memory a DPF for treating depression using the first implant and a DPF for treating Anxiety using the second implant.
  • a DPF may also include an additional data field (not included in TABLE 1 above) that specifies a compatible implant ID.
  • Some of the subroutines disclosed hereinabove may have to be modified by adding steps that instruct the energizing pod once it is placed on the skull above an implant and after establishing a wireless connection to the implant to compare the implant ID with the contents of the data field in the DPF that specifies the compatible implant. If the implant ID matches with the contents of the compatible implant data field, the subroutine proceeds to perform all the remaining steps.
  • the subroutine may notify the patient that the DPF does not match the implant and may either prompt the user to remove the energizing pod and replace it on another implant or simply terminate. In either case, the subroutine may (optionally) log the failed pod placement attempt in a patient log file of the energizing pod which may be transmitted to the smartphone 11 to update the patient log file on the smartphone 11.
  • FIG. 25 is a schematic flow diagram illustrating the steps of a program operating on an energizing pod for checking if a time synchronization action is needed, in accordance with an embodiment of the methods of the present application.
  • the subroutine starts by checking whether the power source voltage in the power source 4 of the pod 19 (of FIG. 4) is lower than a preset voltage threshold value (step 364). If the voltage in the power source 4 is smaller than a preset threshold value, which means that the charge level in the power source is too low to properly operate the pod 19, the subroutine notifies the patient to charge pod (step 363), puts the pod in a locked state (step 369) and terminates.
  • the subroutine checks whether a preset time interval X (as measured by the internal clock circuitry of the pod 19) has passed since the last time a date/time synchronization was performed (step 365). If the preset time interval has not passed, the subroutine waits for a time period T (step 367) and transfers control to step 364. If the preset time interval X has passed since the last time a date /time synchronization was performed, the subroutine puts the pod in a locked state (step 366) and transfers control to step 367.
  • a preset time interval X as measured by the internal clock circuitry of the pod 19
  • the locked state of a pod does not allow the delivery of a therapy session by the locked pod until a time synchronization is performed by the pod with the current time on the main server(s) 12.
  • steps 286-292 of the subroutine illustrated in FIG. 18 and disclosed in detail hereinabove disclose such checking of the locked/unlocked state of a pod and performing a time synchronization with the server(s) 12 if the pod is in a locked state.
  • the subroutine will keep periodically (every time period T) checking the power source voltage (in step 364) and checking whether the preset time interval X has passed (in step 365). If the pod losses power and the voltage of the power source of the pod drops below the voltage threshold value, the pod will be put in a locked state and the subroutine is terminated until the pod is recharged.
  • time interval X and the time period T may be different time periods.
  • T may be preset to five minutes and X may be preset to two weeks.
  • other values of the time interval X and the time period T may be used, depending, inter alia, on the pod’s current consumption in the resting state (when the pod is not being charged and is not being used for energizing an implant), the accuracy of the pod’s internal clock circuitry, and other considerations.
  • FIG. 26 is a schematic flow diagram illustrating the steps of an exemplary method or subroutine usable for connecting an energizing pod to a patient application operating on a communication device included in the local subsystem of FIGS 1, 2 and 7, and for exchanging data with such a device.
  • the patient application including the subroutine
  • the patient application may be installed on the laptop 15 or on a tablet, phablet or notebook substituting the laptop 15.
  • the subroutine may operate on the energizing pods of FIGS. 2, 4, 8 and 9.
  • the subroutine starts by checking if the patient application operating on the smartphone 11 is connected to the energizing pod over a wireless secure connection (step 368). If the patient application is connected to the energizing pod, the subroutine transfers control to step 380. If the patient application is not connected to the energizing pod, the subroutine advertises a wireless connection (step 372), waits for a connection request from the patient application of the smartphone 11 (step 374), establishes a secure link with the patient application (step 376) and uploads data to the smartphone’s log (step 378).
  • the data uploaded by the subroutine in step 378 may be data about therapy session(s) that were initiated directly by the patient 115 (without using the patient’s application of the smartphone 11) in cases in which the smartphone 11 was not available.
  • the initiation of therapy session(s) may be performed by using the user interface 32 of the energizing pod 19 of FIG. 4 as disclosed in detail hereinabove with respect to Fig. 4.
  • the relevant therapy session data is stored on the memory 6 of the pod 19 (because the smartphone 11 is not available).
  • Such stored session data is uploaded to the smartphone 11 and stored in the patient application’s log on the smartphone 11 in step 378.
  • the subroutine After the uploading of the session’s data, the subroutine checks whether the pod is in a locked state (step 380). If the pod is not in a locked state, the subroutine terminates. If the pod is in a locked state, the subroutine notifies the application (operating on the smartphone 11) that the pod is in a locked state (step 382), requests a secure connection to the main server(s) 12 via the patient application (step 384), requests a date/time synchronization from the main server(s) 12 and starts a reply timer running while waiting for the main server(s) reply with date/time data (step 386). The subroutine then waits for a reply from the main server(s) 12 (step 388).
  • the subroutine checks whether the reply signature is valid and the reply timer time is below a preset threshold value (step 390). If the reply signature is not valid or the reply timer time is not below a preset threshold value, or both the reply signature is not valid and the reply timer time is not below a preset threshold value, the subroutine transfers control to step 386. If the reply signature is valid and the reply timer time is below a preset threshold value, the subroutine synchronizes the internal pod clock circuitry with the main server(s) 12 date/time (step 392), unlocks the pod from its locked state and notifies the patient application of the pods unlocking (step 394) and terminates.
  • FIG. 27 is a schematic flow diagram illustrating the steps of an exemplary embodiment of a method or subroutine operable on an energizing pod of the present application and usable for initiating a therapy session by communicating with an implant and with a patient application installed on a device included in the local subsystem 14 of FIGS. 1- 2.
  • the subroutine maybe installed on an energizing pod such as, for example, the energizing pods 19, 29 and 39 of the present application. It is noted that while in the exemplary subroutine (of FIG. 27) the patient application is installed and operates on the smartphone 11, in other embodiments, the patient application may be installed on the laptop 15 or on a tablet, phablet or notebook substituting the laptop 15.
  • the patient 115 may place an energizing pod (such as, for example the pod 19 or 29 or 39) on his or her scalp above the position of the implant 10 (see FIG. 2). The patient may then initiate a therapy session by using the patient application installed on the smartphone 11
  • the systems and methods disclosed in the present application solve the limitations of the systems disclosed in WO/2012/ 154247 by providing the patient 115 with the possibility to control the therapy and interact with the energizing pod bi-directionally, without any other external interface components.
  • the flexibility of the systems and methods disclosed in the present application enables therapies to be updated remotely with low cost and low burden.
  • the implant (such as, for example, the implants 10 and 28) may include a small energy storage device suitable for temporarily maintaining power during brief periods where the wireless power transfer from the energizing pod is lost.
  • a small energy storage device suitable for temporarily maintaining power during brief periods where the wireless power transfer from the energizing pod is lost.
  • such an energy storage device may be a supercapacitor or any other suitable capacitor.
  • the implant may include an energy storage device having a high volumetric energy density that may support primary use of the implants functions and may be periodically re-charged.
  • energy storage devices may include high energy density rechargeable batteries, high energy density capacitors, and high energy density super capacitors that may provide enough power for performing at least one therapy session before requiring recharging.
  • the internal high energy density storage device(s) may be recharged between therapy sessions by placing the energizing pod (such as, for example the energizing pods 19, 29 and 39) on the scalp of the patient 115 as disclosed in detail hereinabove and initiating a charging session.
  • such a charging session may be initiated by using the user interface 32 of the energizing pod to provide a charging command input.
  • the charging command may be performed by pressing and holding pressed the multifunction button 34 of the energizing pod 39 for 20 seconds and then placing the energizing pod 39 on the scalp over the implant.
  • the charging command may be performed by a voice command input using the microphone 40 and voice recognition software operating on the processor/controller 8 of the energizing pod 19.
  • the energizing pod may be removed from the scalp of the patient after the initiation of the therapy session, since the energy storage device of the implant may have sufficient charge to perform an entire therapy session without requiring power from the energizing pod.
  • Such embodiments of the implant may advantageously allow the patient to undergo a therapy session without having to have the energizing pod attached to the scalp (for example, while taking a shower, meeting with friends or any other activity in which the placing of the pod on the scalp may not be possible or may be embarrassing or inconvenient to the patient).
  • the systems disclosed herein have additional modularity and flexibility by allowing the patient 115 to temporarily conduct therapeutic sessions even in the absence of certain components of the local subsystem 14 at least for a certain period of time.
  • the patient 115 may start a therapy session by using either the smartphone 11, or the laptop 15, or by using only the energizing pod(s) 19, 29 and 39 (in the absence of the smartphone 11 or the laptopl5).
  • the systems and methods of the present application may be adapted for treatment of many other neurological or neuropsychiatric disorders such as, for example, any type of depressive disorder, bipolar disorder, obesity, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD), ADD, schizophrenia, an eating disorder (such as, for example, obesity, bulimia, anorexia) and epilepsy by suitably changing the site of implantation of the implants 10 or 28 to deliver therapeutic signals to various different cortical regions, depending on the particular disorder being treated.
  • OCD obsessive-compulsive disorder
  • PTSD post-traumatic stress disorder
  • ADHD attention deficit hyperactivity disorder
  • ADD attention deficit hyperactivity disorder
  • schizophrenia an eating disorder (such as, for example, obesity, bulimia, anorexia) and epilepsy by suitably changing the site of implantation of the implants 10 or 28 to deliver therapeutic signals to various different cortical regions, depending on the particular disorder being treated.
  • the systems and methods may also be able to provide to the patient supplemental therapy sessions, such as, for example, playing a game using the portable communication device, listening to music using the portable communication device, delivering therapeutic visual stimulation using the portable communication device, delivering therapeutic audio stimulation using the portable communication device, prompting a sleep session, providing dietary instructions, prompting physical exercise and any combinations thereof.
  • supplemental therapy sessions may be provided at any time before, during or after the electrical therapy sessions described above.
  • the smartphone 11 may prompt the patient to take a nap.
  • the smartphone 11 may present to the patient a prompt screen offering listening to music using earphones connected to the smartphone 11.
  • the smartphone 11 may offer to the patient to watch visual or audio-visual stimuli presented on the display of the smartphone 11 and/or the speaker of the smartphone 11 or earphones connected to the smartphone 11.
  • the smartphone 11 may present a message to the patient to perform a brief physical exercise (such as, for example, performing pushups and/or other gymnastic exercises, or practicing Tai Chi).
  • the smartphone 11 may provide the patient with instruction to avoid consuming certain foods or beverages or may recommend eating certain foods or beverages (for example avoiding alcoholic drinks).
  • such supplemental therapy sessions may be triggered by the delivery of an electrical therapy session or by the patient’s request to deliver an electrical therapy session.
  • such supplemental therapies may be prescribed to the patient 115 by the clinician in a manner which does not depend on the delivery of an electrical therapy sessions.
  • the DPF may include (optional) data fields specifying some parameters of such supplemental therapy sessions. Such parameters may include, the timing of delivery of a supplemental therapy session and the duration of a supplemental therapy session.
  • the DPF may include data specifying that an audiovisual or audio supplemental therapy with a duration of 10 minutes should be delivered (or offered) to the patient twice daily at 10:00 and 19:00, irrespective of any electrical therapy delivered to the patient during the day or the absence of such electrical therapy on that day.
  • a supplemental therapy When a supplemental therapy is delivered to a patient before during or after an electrical therapy session it may advantageously have a synergistic effect increasing the overall therapeutic efficacy as compared to only delivering an electrical therapy session without a supplemental therapy session.
  • implants 10 and 28 are implanted in the skull of the patient 115, this is not obligatory for practicing the invention and that the systems disclosed herein may include implantable device(s) located elsewhere within the body, such as, for example, a drug pump implanted in the patient’s body, an implant for stimulating or inhibiting a nerve (such as, for example, the vagus nerve or a cranial nerve) or any other suitable implant.
  • implantable device(s) located elsewhere within the body, such as, for example, a drug pump implanted in the patient’s body, an implant for stimulating or inhibiting a nerve (such as, for example, the vagus nerve or a cranial nerve) or any other suitable implant.
  • the secure transfer of the DPF and/or other data may include, but is not limited to, any combination of encrypted links, authentication methods (including multi-factor authentication), secure sockets, digital certificates, and block-chain technologies. Encryption may include asymmetric or symmetric implementations, though symmetric implementations (like AES) are viewed as advantageous due to its more flexible implementation across the multiple devices described herein. Multi-factor authentication may include, but is not limited to, a user password, thumb print, iris scan, retinal scan, facial recognition, and voice recognition.
  • Multifactor authentication has become well-established in devices like smartphones and may be implemented in any of the devices and systems of the present application.
  • Block-chain methods are well-suited for managing and securing the digital prescription data files of the present application, and may have greater security compared to traditional client- server networks, and can be readily implemented via cloud services.
  • call when using the term “call” or “calls” made by the patient, such calls are not limited to telephone calls made by the patient using a mobile phone or a smartphone or a cellular telephone or a tablet having a cellular SIM or supporting e-SIM technology (Virtual SIM) installed therein which use cellular communication protocols. Rather, the term “call or “calls” is used in the present application in a broader sense and means any type of call performed on any device using any type of communication protocol.
  • a call may be performed by using VoIP (voice over internet protocol) or VoWiFi (voice over WiFi protocol) from a smartphone or a mobile phone or a tablet or a phablet or a laptop which has a suitable software application installed therein and that has access to the internet using cellular data protocols and/or WiFi protocols.
  • VoIP voice over internet protocol
  • VoWiFi voice over WiFi protocol
  • Examples of such software applications may include “WhatsApp”, “Skype”, “ICQ”, “Messenger”, or any other application that enables performing voice calls over the Internet.
  • the terms “call” and “calls” refer to voice call(s) performed using any type of telephony or communication methods.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Human Computer Interaction (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un système comprenant un implant pour administrer un traitement à un patient, un module d'excitation pour exciter sans fil l'implant, un sous-système local comprenant un ou plusieurs dispositifs de communication/traitement mobiles ou à porter sur soi capables de commander sans fil le fonctionnement de l'implant et de communiquer avec un poste de travail de praticien pour recevoir un fichier de données de prescription numérique (DPF) comprenant des paramètres thérapeutiques provenant du poste de travail de praticien. Le sous-système local est configuré pour recevoir l'entrée de patient en sélectionnant les valeurs d'un ou de plusieurs paramètres thérapeutiques modifiables par le patient, pour générer un fichier de données de commande d'implant (ICF) comprenant les valeurs des paramètres thérapeutiques modifiables par le patient et pour transmettre sans fil le fichier ICF à l'implant, par l'intermédiaire du module d'excitation, afin de commander le fonctionnement de l'implant.
PCT/IB2024/062882 2024-01-03 2024-12-19 Systèmes thérapeutiques à prescription numérique, modules d'excitation pour de tels systèmes et procédés d'utilisation associés Pending WO2025146594A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463617097P 2024-01-03 2024-01-03
US63/617,097 2024-01-03

Publications (1)

Publication Number Publication Date
WO2025146594A1 true WO2025146594A1 (fr) 2025-07-10

Family

ID=94283815

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2024/062882 Pending WO2025146594A1 (fr) 2024-01-03 2024-12-19 Systèmes thérapeutiques à prescription numérique, modules d'excitation pour de tels systèmes et procédés d'utilisation associés

Country Status (1)

Country Link
WO (1) WO2025146594A1 (fr)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6246911B1 (en) 1999-02-08 2001-06-12 Peter Seligman Cochlear implants with offset coils for transmission of radio frequency links
US6308101B1 (en) 1998-07-31 2001-10-23 Advanced Bionics Corporation Fully implantable cochlear implant system
US7212133B2 (en) 2002-03-15 2007-05-01 Medtronic, Inc. Telemetry module with configurable data layer for use with an implantable medical device
WO2012077088A2 (fr) 2010-12-10 2012-06-14 Cochlear Limited Recharge électrique portable de dispositifs médicaux implantables
WO2012154247A1 (fr) 2011-02-21 2012-11-15 Boston Scientific Neuromodulation Corporation Système de communication avec des dispositifs médicaux implantables à l'aide d'un dispositif passerelle
WO2018109715A1 (fr) 2016-12-14 2018-06-21 Inner Cosmos Llc Systèmes d'interface cerveau-ordinateur et leurs procédés d'utilisation
WO2019130248A1 (fr) 2017-12-28 2019-07-04 Inner Cosmos Llc Systèmes d'interface cerveau-machine intra-calvarium et leurs procédés de fabrication, d'implantation et d'utilisation
WO2019244099A2 (fr) 2018-06-20 2019-12-26 Inner Cosmos Llc Systèmes et méthodes pour le traitement des troubles de l'humeur
WO2020161555A1 (fr) 2019-02-07 2020-08-13 Inner Cosmos Llc Systèmes d'interface cerveau-machine intra-calvarium et leurs procédés de fabrication, d'implantation et d'utilisation
WO2021144730A1 (fr) 2020-01-14 2021-07-22 Inner Cosmos Inc. Dispositifs, systèmes et procédés de stimulation corticale

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6308101B1 (en) 1998-07-31 2001-10-23 Advanced Bionics Corporation Fully implantable cochlear implant system
US6246911B1 (en) 1999-02-08 2001-06-12 Peter Seligman Cochlear implants with offset coils for transmission of radio frequency links
US7212133B2 (en) 2002-03-15 2007-05-01 Medtronic, Inc. Telemetry module with configurable data layer for use with an implantable medical device
WO2012077088A2 (fr) 2010-12-10 2012-06-14 Cochlear Limited Recharge électrique portable de dispositifs médicaux implantables
WO2012154247A1 (fr) 2011-02-21 2012-11-15 Boston Scientific Neuromodulation Corporation Système de communication avec des dispositifs médicaux implantables à l'aide d'un dispositif passerelle
WO2018109715A1 (fr) 2016-12-14 2018-06-21 Inner Cosmos Llc Systèmes d'interface cerveau-ordinateur et leurs procédés d'utilisation
WO2019130248A1 (fr) 2017-12-28 2019-07-04 Inner Cosmos Llc Systèmes d'interface cerveau-machine intra-calvarium et leurs procédés de fabrication, d'implantation et d'utilisation
WO2019244099A2 (fr) 2018-06-20 2019-12-26 Inner Cosmos Llc Systèmes et méthodes pour le traitement des troubles de l'humeur
WO2020161555A1 (fr) 2019-02-07 2020-08-13 Inner Cosmos Llc Systèmes d'interface cerveau-machine intra-calvarium et leurs procédés de fabrication, d'implantation et d'utilisation
WO2021144730A1 (fr) 2020-01-14 2021-07-22 Inner Cosmos Inc. Dispositifs, systèmes et procédés de stimulation corticale

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ANDREA SGOIFOLUCA CARNEVALIMARIA DE LOS ANGELES PICO ALFONSOMARIO AMORE: "Autonomic dysfunction and heart rate variability in depression", STROKE, vol. 18, no. 3, 2015, pages 343 - 352
JAMES A. RUSSEL: "A Circumplex Model of Affect", JOURNAL OF PERSONALITY AND SOCIAL PSYCHOLOGY, vol. 39, no. 6, 1980, pages 1161 - 1178
PANICCIA ET AL.: "Clinical and non-clinical depression and anxiety in young people: A scoping review on heart rate variability", AUTONOMIC NEUROSCIENCE: BASIC AND CLINICAL, vol. 208, 2017, pages 1 - 14, XP085309892, DOI: 10.1016/j.autneu.2017.08.008
ROBERT LIKAMWA, YUNXIN LIU, NICHOLAS D. LANE LIN ZHONG: "Building a Mood Sensor from Smartphone Usage Patterns", 25 June 2013

Similar Documents

Publication Publication Date Title
US12364393B2 (en) System and method for collecting and displaying data acquired from an implantable therapy device using a consumer electronic device
US20250032793A1 (en) Methods and systems to diagnose depression
US20230065880A1 (en) System and method for secured sharing of medical data generated by a patient medical device
US9596224B2 (en) Systems, devices, components and methods for communicating with an IMD using a portable electronic device and a mobile computing device
AU2014218626B2 (en) Methods and apparatuses for networking neuromodulation of a group of individuals
US8140160B2 (en) Systems and methods for interacting with an implantable medical device
US20190046794A1 (en) Multi-factor control of ear stimulation
JP2012509103A (ja) 療法調整のための感知システム、デバイス、および方法
US20170259072A1 (en) System architecture for medical implant
CN111447969A (zh) 用于影响副交感神经和交感性神经活动以达到治疗效果的周围神经刺激装置
US20160008632A1 (en) Methods and apparatuses for networking neuromodulation of a group of individuals
US20160279435A1 (en) Ear stimulation with neural feedback sensing
US20220401739A1 (en) Cloud-based sensor operation adapted to patient behavior
WO2023000789A1 (fr) Procédé d'enregistrement d'informations de programmation et appareil associé
US20240304314A1 (en) Predictive medical device consultation
WO2025146594A1 (fr) Systèmes thérapeutiques à prescription numérique, modules d'excitation pour de tels systèmes et procédés d'utilisation associés
CN117980999A (zh) 临床医生任务优先级排序
US20260061196A1 (en) Techniques for a wearable electronic stimulating device
WO2026052744A1 (fr) Dispositif de stimulation électronique pouvant être porté, procédé de fonctionnement d'un dispositif de stimulation électronique pouvant être porté et système de fonctionnement d'un dispositif de stimulation électronique pouvant être porté
CN117914020A (zh) 无线充电认证方法、设备、体外充电系统及存储介质
CN118199779A (zh) 植入式设备的对时方法及相关装置
NO20241254A1 (en) A wearable electronic Vagus Nerve Stimulating, VSN, device, a method for treatment of chronic pain conditions and a system for operating a wearable electronic Vagus Nerve Stimulating device
HK1219591B (zh) 用於一组个体的联网的神经调节的方法和装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24838019

Country of ref document: EP

Kind code of ref document: A1