WO2015092747A2 - Dispositif médical avec régulation séparée - Google Patents

Dispositif médical avec régulation séparée Download PDF

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Publication number
WO2015092747A2
WO2015092747A2 PCT/IB2014/067096 IB2014067096W WO2015092747A2 WO 2015092747 A2 WO2015092747 A2 WO 2015092747A2 IB 2014067096 W IB2014067096 W IB 2014067096W WO 2015092747 A2 WO2015092747 A2 WO 2015092747A2
Authority
WO
WIPO (PCT)
Prior art keywords
optionally
implant
intrabody
sticker
data
Prior art date
Application number
PCT/IB2014/067096
Other languages
English (en)
Other versions
WO2015092747A3 (fr
Inventor
Shlomo Ben-Haim
David Prutchi
Yuval BEN-HAIM
Original Assignee
Tylerton International 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 Tylerton International Inc. filed Critical Tylerton International Inc.
Publication of WO2015092747A2 publication Critical patent/WO2015092747A2/fr
Publication of WO2015092747A3 publication Critical patent/WO2015092747A3/fr

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Classifications

    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • A61B2560/0219—Operational features of power management of power generation or supply of externally powered implanted units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4205—Evaluating swallowing
    • 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
    • A61B5/4842—Monitoring progression or stage of a disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/10—Office automation; Time management
    • 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
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • 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
    • 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
    • G16H40/67—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 remote operation

Definitions

  • the present invention in some embodiments thereof, relates to medical systems, for example, treatment systems, for example implantable stimulation systems and methods and, more particularly, but not exclusively, to a stimulation system including an implanted part and a non-implantable controller, optionally including one or more disposable dose setting components.
  • the present invention in some embodiments thereof, relates to medical systems, for example, treatment systems, for example implantable stimulation systems and methods and, more particularly, but not exclusively, to a stimulation system including an implanted part and a non-implantable controller, optionally including one or more disposable dose setting components.
  • a multi-part stimulation system comprising an intrabody portion and an external portion configured for temporary attachment to the skin and which wirelessly transmits one or both of power and commands to said intrabody portion and/or is configured to receive sense data from said intrabody portion.
  • a method of providing an intrabody stimulation therapy comprising implanting an intrabody portion and activating or modulating treatment using at least 4 different external portions coupled sequentially to the intrabody portions.
  • an intrabody portion comprising: a medical payload
  • a wireless receiver connected by a data connection to said control circuitry; and a separate component small enough by (a) being adapted to be temporarily mechanically coupled to a human body without affecting ambulation thereof, or (b) weighting less than 75 grams, comprising:
  • a wireless transmitter wirelessly couplable to said wireless receiver and configured to transmit one or more of data, power and instructions to said intrabody portion.
  • said separate component includes a data storage thereon and is configured to send data to said wireless receiver from said data storage.
  • separate component includes a data storage thereon and is configured to receive data from said wireless receiver and store said data in said data storage.
  • said separate component includes a data storage in the form of a passive transponder.
  • said separate component includes a data storage thereon and is configured to send instructions operable by said control circuitry, from said data storage to said wireless receiver.
  • said instructions comprise only an on or an off instruction.
  • said instructions comprise only a setting for a single parameter of said medical payload.
  • said instructions comprise a setting for a plurality of parameters of said medical payload.
  • said instructions comprise an operational mode.
  • said instructions comprise operational logic.
  • said separate component includes a sensor and is configured to send sensor readings to said wireless receiver.
  • said sensor is configured to receive a human input and act as an interface for said intrabody portion.
  • said sensor is an environmental sensor and said control circuitry modifies activity thereof in response thereto.
  • said sensor is a physiological sensor and said control circuitry modifies activity thereof in response thereto.
  • said separate component includes a generator of a human sensible signal and is configured to generate said signal in response to a signal from said control circuitry thereby acting as a user interface therefor.
  • said separate component includes a power source and is configured to transmit power from said power source to power or charge said intrabody portion.
  • said transmitted power is sufficient only for fewer than 5 treatments by said medical payload.
  • said separate component includes a communication module and is configured to act as a gateway between said intrabody portion and an external component.
  • the system comprises a controller adapted to interface via said gateway with said intrabody portion.
  • said separate component comprises an adhesive layer adapted to temporarily attach to the skin of a human.
  • said separate component is thinner than 5 mm.
  • said separate component is sized to be swallowed.
  • said separate component is flexible enough to bend with the skin when attached to a back or an abdominal portion of an adult human.
  • said separate component has a maximal dimension of less than 15 cm.
  • said separate component has a weight of less than 50 grams.
  • said wireless receiver and said wireless transmitter are configured to inter-operate only over distances of less than 5cm with intervening tissue thickness of at least 1 cm.
  • said intrabody portion includes a wireless transmitter and wherein said separate component includes a wireless receiver for receiving data from said intrabody portion.
  • said control circuitry is configured to transmit an indication of the effectiveness of a treatment mandated by said separate component, to said separate component.
  • said intrabody portion includes a memory having stored therein an account and wherein said control circuitry provides a therapy using said medical payload responsive to a status of said account, and wherein said account is replenishable by said wireless receiver.
  • said separate component includes a memory having stored therein an account and wherein data indicative of a status or contents of said account is transmittable by said wireless transmitter to said intrabody portion.
  • said intrabody portion includes all components necessary for using said medical payload other than instructions or authorization from said separate component.
  • said intrabody portion can sense a relative location of said separate component and wherein said control circuitry operates said medical payload responsive to said sensed relative location.
  • said system includes a plurality of separate components, and said intrabody portion can communicate with the plurality of separate components and wherein said control circuitry operates said medical payload responsive to said plurality of components.
  • said intrabody portion is configured to apply at least one type of therapy only in response to the presence of a suitable separate component.
  • said intrabody portion is configured to apply at least one type of therapy even in the absence of any separate component.
  • said separate component includes a sensor and a display and generates a display indicating an effect of therapy by said medical payload in response to said separate component, as sensed by said sensor.
  • the system comprises a second separate component attachable to said separate component and configured to modify the transmission of data by said separate component to said intrabody portion.
  • the system comprises a billing server which coordinates billing and usage of said intrabody portion by receiving data from said separate component and/or issuing data to said separate component.
  • the system comprises a server which authorizes data in said separate component to said intrabody portion.
  • said intrabody portion is a wholly implantable stimulation system.
  • said wireless receiver comprises an antenna adapted to extend from a body of said implant and lie near a surface of the human body.
  • said separate component includes a degrading component which deactivates said component after use.
  • a separate component for use with an implantable medical device comprising:
  • the component comprises a deactivator which reduces functionality of said component after use.
  • the data includes one or both of digitally signed settings for said implantable device, and an identification of said implantable device.
  • the component comprises one or more of power storage and a sensor.
  • kits comprising at least 10 components as described herein.
  • at least two of said components are configured to have different effects on operation of said implantable medical device.
  • an intrabody medical system comprising:
  • control circuitry programmed to activate said medical payload
  • account memory storing therein at least one value indicating one or more authorizations to activate and operatively connected to said receiver circuitry to receive said value
  • the control circuitry is configured to activate said medical payload responsive to one or more authorizations from said account memory and thereafter consume at least one authorization.
  • the system comprises a plurality of account memories with distinct values.
  • said account memory stores said authorizations as a number.
  • said account memory stores said authorizations as a set of separate authorization codes.
  • said account memory is able to store fewer than 1 year worth of authorizations for said medical payload.
  • said account memory is able to store fewer than 100 authorizations for said medical payload.
  • said account memory is able to store between 5 and 50 authorizations for said medical payload.
  • said control circuitry selectively activates said medical payload also in response to a sensor reading.
  • said control circuitry is also configured to activate said medical payload to provide a therapy absent authorization in said account.
  • said therapy is different from a therapy activated in response to said one or more authorizations.
  • said control circuitry is configured to unlock a functionality of said medical payload in response to said authorization.
  • said control circuitry is configured to change at least one parameter of application of said medical payload in response to said authorization.
  • said control circuitry is configured to change a number of authorizations needed for activation.
  • said control circuitry is configured to detect a lack of use of said system and cause one or more incentives to be offered to a patient in which the system is implanted.
  • said control circuitry is configured to transmit an effect of said activating.
  • said control circuitry is configured to budget treatment account to said account, when said account includes sufficient authorizations for activating said medical payload.
  • the system comprises an out of body controller configured to transmit an authorization to said receiver circuitry.
  • said controller includes at least one account for storing at least one value indicating one or more authorizations thereon.
  • said controller includes at least one power transmitter for recharging said intrabody medical system and wherein said controller includes a limiter preventing full recharging absent authorization in said account.
  • said controller includes a programmer for programming a small component, which component includes a transmitter for transmitting said authorization directly to said receiver circuitry.
  • a medical system comprising:
  • a therapeutic system comprising:
  • control circuitry programmed to activate said medical payload
  • account memory storing therein at least one value indicating one or more authorizations to activate and operatively connected to said receiver circuitry to receive said value
  • control circuitry is configured to activate said medical payload responsive to one or more authorizations said account memory and thereafter consume at least one authorization
  • a separate component having stored thereon at least one authorization and including a transmitter for transmitting said at least one authorization to said receiver circuitry.
  • a controller including circuitry for programming an intrabody medical system and configured to transmit a consumable authorization to a receiver circuitry.
  • the method comprises repeating said receiving and said consuming while said separate component is affixed to a patient within which said medical system is implanted and during ambulation of said patient.
  • said authorization comprises the presence of said component.
  • an intrabody portion comprising:
  • control circuitry which receives data from said wireless transceiver, activates said medical payload in response thereto and transmits an effect of said treatment sensed by said sensor via said wireless transceiver;
  • an external portion comprising:
  • transceiver for transmitting said data and for receiving said effect
  • a display for displaying an indication of said effect.
  • a method of using a medical implant comprising allocating a patient in need thereof a plurality of authorizations; and activating said medical implant to provide treatment in response to consuming at least one of said authorizations.
  • the method comprises modifying said consuming or at least partially refunding an authorization or monetary equivalent in response to a measure of effectives of said treatment.
  • the method comprises providing said authorization by a health care provider.
  • the method comprises providing said authorizations by a pharmacy.
  • a method of using a medical implant comprising allocating a patient in need thereof a plurality of authorizations, at least two of which carry different data; and activating said medical implant to selectively provide a first treatment or a second treatment in response to said different data.
  • a method of programming a medical implant having a wireless receiver comprising: approximating to a body adjacent an antenna of said wireless receiver at least one data carrying component;
  • the method comprises approximating simultaneously a plurality of data carrying components and modifying plurality of parameter settings in response thereto.
  • said implant retains said parameter setting until modified by a different data carrying component.
  • said modifying depends on a relative position of said component and said antenna.
  • an intrabody portion comprising:
  • control circuitry which receives data or power from said wireless transceiver and selectively activates said medical payload in response thereto responsive to said sensor.
  • aspects of the present invention may be embodied as a system, method or computer program product. Accordingly, aspects of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a "circuit," “module” or “system.” Furthermore, aspects of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. 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-disk 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.
  • the computer readable medium may be a computer readable signal medium or a computer readable storage medium.
  • a computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing.
  • a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.
  • a computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof.
  • a computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.
  • Program code embodied on a computer readable medium may be transmitted using any appropriate medium, including but not limited to wireless, wire/line, optical fiber cable, RF, etc., or any suitable combination of the foregoing.
  • Computer program code for carrying out operations for aspects of the present invention may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages.
  • the program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server.
  • the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).
  • LAN local area network
  • WAN wide area network
  • Internet Service Provider for example, AT&T, MCI, Sprint, EarthLink, MSN, GTE, etc.
  • These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.
  • the computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
  • FIG. 1 is a block diagram showing a stimulation system in accordance with exemplary embodiments of the invention
  • FIG. 2 is a block diagram showing an alternative stimulation system in accordance with some exemplary embodiments of the invention.
  • FIG. 3 is a block diagram showing another alternative stimulation system in accordance with some exemplary embodiments of the invention.
  • FIG. 4 is a showing of a stimulation system based on the design of Fig. 1, in accordance with some exemplary embodiments of the invention.
  • FIG. 5 shows an exemplary delivery system for the implantable component of the system of Fig. 4, in accordance with some exemplary embodiments of the invention
  • FIG. 6 shows the system of Fig. 4 implanted in a stomach, in accordance with some exemplary embodiments of the invention
  • FIG. 7 is a pulse diagram showing a pulse sequence, in accordance with some exemplary embodiments of the invention.
  • FIG. 8 is a detailed block diagram showing the distribution of electronic components inside and outside the body, in an exemplary system according to Fig. 4;
  • FIG. 9 is a cross-sectional view of an external portion of an exemplary system according to Fig. 1 and/or other embodiments of the invention.
  • FIG. 10 is a flowchart of an operation of an implanted system, in accordance with some exemplary embodiments of the invention.
  • FIG. 11 is a flowchart of a method of using an implanted system according to some exemplary embodiments of the invention.
  • FIG. 12 is a flowchart of a method of treating a patient using an implanted system according to some exemplary embodiments of the invention.
  • FIG. 13 is a flowchart of a method of implanting a system according to Fig. 4, using the delivery system of Fig. 5, in accordance with some exemplary embodiments of the invention
  • FIG. 14 is a schematic of a system using one or more accounts to manage a device functionality, in accordance with some exemplary embodiments of the invention.
  • FIG. 15 is a flowchart of a method of using the system of Fig. 14, in accordance with some exemplary embodiments of the invention
  • FIG. 16A is a schematic showing of a swallowable activator for an implanted medical device, in accordance with some exemplary embodiments of the invention
  • FIG. 16B is a block diagram of a pill-using implant system, in accordance with some embodiments of the invention.
  • FIG. 17 is a schematic showing of spatial control in accordance with some embodiments of the invention.
  • FIG. 18 is a schematic showing of a system with a peripheral for an implant or other medical device, in accordance with some exemplary embodiments of the invention.
  • FIG. 19 is a schematic showing of a non-implantable medical device using a separate controller in accordance with some embodiments of the invention.
  • FIG. 20 is a schematic showing of a system having a sticker whose use is limited using one or more mechanisms, in accordance with some exemplary embodiments of the invention.
  • FIG. 21 is a flowchart of a method of device-mediated cost control, in accordance with some embodiments of the invention.
  • the present invention in some embodiments thereof, relates to medical systems, for example, treatment systems, for example implantable stimulation systems and methods and, more particularly, but not exclusively, to a stimulation system including an implanted part and a non-implantable controller, optionally including one or more disposable dose setting components.
  • An aspect of some embodiments of the invention relates to a medical system including a main body and a separate component (e.g., a control component) coupled to the main body without wires.
  • a stimulation system including an internal stimulator and an external (e.g., control) portion, functionally connected to the internal portion without wires.
  • the control portion provides one or more of power, operating instructions, processing services and/or communication services to said main body (e.g., internal portion).
  • the external control portion is in the form of an adhesive sticker. Other form factors may be provided as well, for example, as described herein.
  • stimulation is used to describe any of various effects of a stimulating power applied to target tissue(s) including a modulation, a modification, an activation, a deactivation, an organ or sub organ opening effect, an organ or sub organ closing effect, an irritation and/or the like.
  • stimulation be provided as a non-electrical modality, for example, electro-magnetic, magnetic or light stimulating or stimulation using chemical means (e.g., drugs).
  • this configuration may also be used for non-implantable systems.
  • this configuration can be used for non- stimulatory systems, for example, systems providing therapy in another manner or systems which are diagnostic.
  • circuitry and/r mechanical or other components which provide medical stimulation, therapy and/or monitoring functionalities may be termed a "medical payload".
  • a particular feature of some embodiments of the invention is allowing the control of costs and/or therapy of an implantable stimulation device, optionally using a simplified interface of "stickers" which are placed on the outside of the body and which effect control and/or manage costs, for therapy associated with the implanted device.
  • the intrabody part is permanent or semi-permanently implanted, while the external part is temporary, for example, being used for a duration of between 1 second and one month or longer, for example, between 1 minute and 1 hour or between 6 hours and one month.
  • the external portion is mechanically coupled to the body during use and is not hand-held. In an exemplary treatment regime, between 1 and 100 or more, for example, between 10 and 50 different external portions may be used with a same internal portion.
  • the external portion is reusable, for example by recharging.
  • a code indicating a reuse is generated and used for billing (e.g., a recharger may have a limited number of recharges allowed or the code may be sent to a billing computer).
  • the bulk of the system functionalities are provided in the external portion.
  • at least 70%, 90%, 95% or more of energy storage capacity that stores energy for more than one minute is found outside the body, optionally attached to the body (e.g., using adhesive or a strap or other mechanical coupling).
  • at least 70%, 90%, 95% or more of processing capacity e.g., measured in FLOPS or MIPS
  • at least 70%, 90%, 95% or more of circuitry e.g., transistors
  • circuitry e.g., transistors
  • the external portion is semi- permanently attached to the body so as to be adjacent to at least an antenna section of said internal portion.
  • this external portion when a power source thereof is exhausted and/or after a given time period and/or a treatment course, this external portion is optionally replaced.
  • a pack including multiple such disposable portions is used. Exhausted portions are optionally thrown away or provided for recycling (e.g., recharging and/or reprogramming, for example at home or at a central location such as a clinic or pharmacy).
  • RF or magnetic coupling is used to send power from said outside portion to said inside portion.
  • RF transmission or coupling is used to send data from said inside portion to said outside portion.
  • the inside portion does not include power storage sufficient for applying a complete pulse sequence (e.g., of more than one minute).
  • signals sensed by the internal portion are processed by said external portion, for example, to detect conditions where stimuli should or should not be applied.
  • the external portion or a component attachable thereto is used to provide commands for stimulation. This may be useful even for embodiments where the internal portion includes substantial power storage and/or circuitry.
  • the external component or portion may be used to charge the internal portion with power sufficient to apply part or all of a treatment regime and/or a sensing regime.
  • a patient can purchase (or otherwise receive) a set of such components, possibly in the shape of pills, which are loaded (e.g., one by one) into and/or mounted on the external portion, to set dosage and/or treatment logic.
  • the external portion is separately sold (or otherwise provided) and/or packaged therewith and provided power and/or processing support.
  • power is sent from the external portion to the internal portion to power sensing. Then sensed signals are sent to the external portion for processing. Then the external portion sends a treatment signals and power to the internal portion, for providing a treatment stimulus.
  • the external portion can communicate with a remote server or with a local server, for example, directly, or via an intermediary gateway.
  • a cellphone can communicate with the external portion using a wireless link.
  • the external portion and/or component, once removed, are coupled to a reader for retrieving information therefore and sending to the remote server.
  • what is read from the component and/or external portion include one or more of actual applied signals, application profile, problems with applications, sensed signals and/or data otherwise logged thereby.
  • a remote server is at least 100 or 1000 meters away.
  • a local server is between 10 and 0.1 meters away or closer.
  • a single lead body is used with a bipolar electrode for both sensing and stimulating.
  • a second electrode is provided in the internal portion, for less localized sensing when used together with one or both of the bipolar electrode contacts.
  • the electrode e.g., bi-polar
  • a tissue attachment mechanism such as a clip or a threading for screwing into muscle tissue.
  • an electrode portion is attached to (e.g., screwed into) target tissue and includes an elongate flexible tail, ending with an energy collector.
  • the energy collector is designed to anchor a short distance below the skin, so as to simultaneously be more efficient in energy receiving (e.g., than transmission to a deeply implanted part of the implant) and maintain sterility.
  • the energy collect is implanted between a muscle layer (e.g., abdominal or chest muscles) and the skin, optionally in subcutaneous fat layer.
  • the energy collector is a coil or flat element with a radial extent of at least 1 cm outside of the body of the implant.
  • the body of the implant is mostly an elongate tube of maximum radial extent of between 0.1 and 3 mm or more, for example, less than 2 mm or 1 mm.
  • the skin above the energy collector is marked for easy alignment of attachment of the external portion, for example, using a temporary or permanent tattoo or using a magnet and a second magnet or a ferromagnetic material, one in the implant near the skin and one in the sticker or other external component.
  • delivery of the implant is by needle, optionally under ultrasound imaging or using a detector at the tip of the needle to detect a signal form a target organ (e.g., a light source provided inside the stomach).
  • a target organ e.g., a light source provided inside the stomach.
  • the needle is guided to the target tissue and then the implant is rotated to screw it into the target tissue (other attachment means may be used as well). Then the needle is retracted and at a point just below the skin, the rear end (with the energy collector) of the implant is released below the skin.
  • the rear end includes a loop (e.g., of metal) to assist removal from the body (e.g., using a hook to grab the loop and put the device out).
  • the electrode(s) is mechanically coupled to the body of the intrabody portion, at least in part, by a suture or a pin which can be released by pulling on a thread that extends to a skin side of the intrabody portion. Retracting the thread weakens the coupling so that an additional retraction force applied to the body separates the body from the electrode(s).
  • the electrode is attached to the target tissue by a suture, and pulling the thread opens the suture, releasing the electrode from the target tissue.
  • the external portion is also used to deliver drugs.
  • the body of the implant serves to channel such delivered drugs to the target tissue, for example, acting as a capillary channel therefore.
  • the implantation is temporary and the attachment to target issue weakens over time (e.g., by the electrode including a stiffening element made of bio- absorbable material), to assist in device removal.
  • the external portion e.g., a sticker
  • the implant in a certain activation state (e.g., "on") and removal thereof will cause the implant to change state (e.g., to "standby” or “off or “low functionality” or “default”), for example, by the implant not identifying a nearby "activating" sticker.
  • Power and/or other functionalities of the implant may be provided in the implant, rather than via the sticker, with the sticker acting, possibly only, as a control mechanism.
  • the implant is capable of providing a plurality of types of therapy (e.g., in a pacemaker: pacing in various modes, CRT, ICD, CCM and anti-arrythmia pacing) and/or a therapy with a plurality of different parameter settings and some of the therapy types and/or settings are blocked when the implant is not an in "on" and/or other authorized state.
  • a pacemaker pacing in various modes, CRT, ICD, CCM and anti-arrythmia pacing
  • a therapy with a plurality of different parameter settings and some of the therapy types and/or settings are blocked when the implant is not an in "on" and/or other authorized state.
  • an aspect of some embodiments of the invention relates to an external control portion/component for a medical implant, for example, in the form of a sticker and/or otherwise being small.
  • the control portion has a thickness of less than 30 mm, less than 20 mm, less than 10 mm, less than 5 mm, less than 3 mm or intermediate thicknesses.
  • the control portion has a maximal cross-sectional area of less than 400 cm A 2, less than 100 cm A 2, less than 50 cm A 2, less than 10 cm A 2, less than 5 cm A 2, less than 2 cm A 2 or intermediate areas.
  • the control portion is flexible enough to bend with the body, for example, with the abdomen, hips and/or back.
  • control portion as a whole has a bending radius (for a bending form 180 degrees to 120 degrees) of less than 10 cm, less than 5 cm, less than 3 cm, less than 1 cm, or an intermediate bending radius whereby the portion can be bent without damage thereto.
  • the portion may include one or more relatively rigid portions, but as a whole, the above bending radii are optionally provided.
  • control portion or other separate component weights less than 100 grams, less than 50 grams, less than 20 grams, less than 5 grams or intermediate weights.
  • control portion includes a layer of adhesive suitable for attachment thereof to skin (or a device in relevant embodiments).
  • adhesive and the control portion
  • the adhesive are water resistant, for example, to allow bathing and/or swimming.
  • control portion provides control instructions and includes data storage for storing one or more instructions thereon.
  • control portion includes a communication module, for example, in the form of an RFID tag, for reading by the implant.
  • data storage contains encrypted data.
  • the data storage is used to store data transmitted from the implant.
  • the data storage includes authorization, for example, in the form of an account or one or more token which each provide a limited amount of activity of the implant.
  • control portion provides data in the form of instructions for the implant, which instructions, and/or parameter settings define a logic (e.g., sequential actions and/or decision making) to be applied by the implant, thereby acting as operational logic.
  • a logic e.g., sequential actions and/or decision making
  • the data and communication modules are in the form of a passive responder, for example, a passive RFID circuit.
  • control portion includes a reader for reading a smart card or other mobile data carrying device (e.g., via USB or wireless means).
  • a programmer can be used to program the control portion, for example, by sending data to the control portion.
  • the control portion includes a battery. In some embodiments, the control portion is passive. In some exemplary embodiments of the invention, the control portion includes an antenna for receiving power beamed by a power source, such as a programmer and is optionally configured (e.g., with a transmission coil) to retransmit the power to the implant as power (e.g., in a sufficient amount to be useful) and/or as data (e.g., in an amount useful for reading but not activating any part of the implant).
  • a power source such as a programmer and is optionally configured (e.g., with a transmission coil) to retransmit the power to the implant as power (e.g., in a sufficient amount to be useful) and/or as data (e.g., in an amount useful for reading but not activating any part of the implant).
  • control portion includes a mechanism for limiting use thereof, for example, instructions being digitally signed to work with only a certain implant and/or time and/or include a degrading component which deactivates the control portion after a period of time.
  • control portion includes a sensor for sensing one or more physiologically related input and/or a user input and sending such input, optionally after processing, to the implant.
  • control portion includes one or more output, such as a light or a sound generator.
  • control portion includes one or more input sensors, such as a light sensor or a microphone (e.g., for voice or other sound related inputs, which may be processed in the control portion and/or in the implant).
  • the control portion includes a positioning mechanism, for example, based on magnetic interaction.
  • the control portion include a ferro-magnetic element and a magnet is implanted, or vice versa, so that correct positioning of the control portion can be sensed based on the interaction of the two magnetically active or reactive components.
  • a light or sound generator on the control portion generates a signal based on a sensing of the implant (or an antenna thereof) by the component.
  • control portion and the implant are designed for communication over a range of, for example, less than 20 cm, less than 10 cm, less than 5 cm, less than 2 cm and/or less than 1 cm.
  • a minimum range is at least 1 cm, 3 cm, 5 cm or intermediate amounts of intervening flesh (e.g., muscle and/or fat and/or connective tissue).
  • transmission over greater ranges is not provided.
  • Range setting is optionally by selecting of amplification and sensitivity of transmitter and/or receiver circuits in the system.
  • the distance is detected (e.g., based on received power level) and transmission over a greater distance is not allowed.
  • An aspect of some embodiments of the invention relates to a method of treatment of a patient.
  • an implanted portion is implanted in a patient and then an external portion (or a component therefore) is attached above the energy collector, as needed, for example, based on a need felt by the patient (e.g., in response to nausea) or a medical prescription (e.g., twice a day for a month).
  • the external portion and/or component provide one or more of dosing instructions, power for such dosing and/or logic (e.g., sensing instructions and/or circuitry for deciding when to treat).
  • different diseases are treated using different pulse regimes and/or in response to sensing different conditions.
  • a pharmacy may issue a package of, for example, 10 disposable components, directed to applying a certain dosage in response to certain conditions.
  • decision to apply treatment is made by the patient, for example, based on self monitoring and/or felt need.
  • the external component is used to collect information (e.g., from the implant, the body and/or environment), which is then uploaded to a processing system (e.g., a dedicated reader or a cellular telephone).
  • a processing system e.g., a dedicated reader or a cellular telephone.
  • a patch may include one or more sensor and also sense signals from the implant.
  • the quality and/or type of processing of signals provided by the implant is set by the patch.
  • some or all of the processing circuitry e.g., possibly other than a pre-amplifier, encoder and/or A/D converter
  • Different patches may, for example, be designed to recognize different patterns.
  • a component attached to the external portion decides what type of processing will be carried out by the external portion.
  • Exemplary optional features which may be provided in the patch include reminder generation (e.g., to a cellphone when it is near or programming a cell phone when first applied), color changes when power is down, includes a test button and a simple display such as a LED and/or one or more sensors (e.g., an accelerometer).
  • reminder generation e.g., to a cellphone when it is near or programming a cell phone when first applied
  • color changes when power is down includes a test button and a simple display such as a LED and/or one or more sensors (e.g., an accelerometer).
  • a kit for a caregiver is provided.
  • the external portion can respond to the placement of and/or manipulation of and/or signal from a tool thereon by an action, such as sending a stimulus to the patient or uploading data.
  • the tool is in the shape of a handle with an extension, which optionally fits in an optional recess in the external portion.
  • the tool is attachable to the external portion.
  • the external portion includes an RFID reader to identify the tool and/or read instructions therefrom.
  • the tool is placed in lieu of a component and optionally utilizes same power and/or communication circuitry in the external portion to control the external portion and/or intrabody portion.
  • the implant has multiple sensitive zones (e.g., multiple antennas) and a sticker has a different effect at different locations.
  • each location may trigger stimulation to a different body part.
  • a parameter of an implant which is controlled by sticker coding is a location of treatment of the implant (e.g., which of several sets of electrodes of the implant to activate for treatment, is decided based on the sticker encoding).
  • an aspect of some embodiments of the invention relates to safety.
  • the implant does not automatically respond to a power input by stimulating the target tissue. Instead, the implanted portion may require an authentication, for example, a correct interrogation code sent to an RFID therein.
  • the implant includes safety logic which, for example, prevents it from applying stimulation too soon after applying a previous stimulation (e.g., by comparing timestamps of commands to stimulate provided by an external portion to each other and/or a threshold).
  • An aspect of some embodiments of the invention relates to a two part implant, wherein an intrabody portion receives a command, and substantially simultaneously (e.g., within 5 seconds or less), power, to carry out the command (e.g., to stimulate) from an external portion but delays in carrying out the command based on inner logic.
  • the delay is between 1 ms and 5 hours long, for example, between 1 ms and 10 minutes, for example, between 1 second and 1 minute and is optionally used for one or more of analyzing safety, authorization, authentication, timing and/or payment for carrying out the command.
  • the delay is long enough to require power storage in the implant of power to the implant, for example, in a rechargeable battery or in a super capacitor.
  • the transmission primes the implant to operate, but such operation is only in response to a determined need by the implant, for example, as indicated by one or more sensors of the implant.
  • An aspect of some embodiments of the invention relates to risk allocation in a medical device use, in which a permanently implanted medical device is of low financial risk to a user.
  • the cost of the implanted part and/or implantation procedure is kept low and payment is according to a consumed disposable. If the treatment is effective, more disposable parts will be consumed and thus total payment can rise. If the treatment is not effective, it can withheld (like a drug) and costs avoided.
  • An aspect of some embodiments of the invention relates to management of a medical device, for example, an implantable medical device.
  • management is by providing one or more accounts for device functionality, which accounts are consumed/emptied by device usage and where a functionality of an account is inaccessible when the account is empty.
  • an account is implemented as a storage location including a value which is, for example, increased or decreased as the account is consumed or replenished.
  • the account is implemented as a storage location which can store a plurality of codes, each code corresponding to one or more usage units and which codes may be deleted or otherwise marked as used, once used.
  • accounts are refilled using refill elements.
  • one or more accounts is stored in the device.
  • one or more accounts are stored in a controller/charger/programmer of the device and which allows functioning of the device according to account state.
  • a handheld refill element e.g., a smartcard
  • a handheld refill element may be provided which includes a refill for one or more account and which is optionally loaded at once, or piecemeal into the device.
  • a single account ties together multiple functionalities.
  • one or more of the following accounts is provided: therapy, diagnosis, data logging, programming and data readout.
  • the account stores units and a particular (optionally different) number of units is used for each device functionality.
  • the account is a power account and, optionally, the device does not apply a functionality if it does not have sufficient power to support basic operation, such as life-saving functionality.
  • accounts may refill without a refill element.
  • a quality of life feature account may be filled responsive to a patient following therapy, such as doing sufficient exercise.
  • slow refilling over time is provided, so that a low availability of functions is provided, at least.
  • An aspect of some embodiments of the invention relate to controlling an implant by controlling a charger thereof.
  • power is provided to an implant only if one or more tokens are provided to the charger.
  • the tokens are provided as a refill card.
  • a user can select how many of available power units to move from a charger to an implant.
  • the power units are actual energy amounts.
  • the units are virtual units which reflect a permission of the recharger to charge the implant and/or send commands, read data from or otherwise interact with the implant.
  • the control logic to manage the implant is provided by the implant (e.g., with the implant evaluating and/or storing tokens and/or sending requests to a server for authentication of the tokens), rather than or in addition to the charger. This may prevent a "hacked" charger from being used to charge an implant without authority.
  • an implant is always chargeable to a minimal safety amount.
  • a charge limiter circuitry is provided in the charger and/or the implant to prevent charging to full capacity absent authorization form an account.
  • the implant does not apply higher functionality below a minimum charge level thereof.
  • An aspect of some embodiments of the invention relates to an implantable device with multiple operational modes, selectable by a user.
  • the device includes at least two operational modes and at least one therapeutic, diagnostic and/or logging functionality available in one mode but not in another.
  • the device defaults to one of the modes and a user may activate the device to a non- default mode using external means, for example a binary control, such as a sticker or pill- shaped element which changes the mode, or by manipulation of a controller/programmer/charger of the implant.
  • At least some states are accessible only upon payment, for example, an external means may be provided or charged in response to payment and then be usable to control the implant to a higher functionality mode.
  • the device provides at least life- saving functionality (e.g., defibrillation), even in a default mode.
  • life- saving functionality e.g., defibrillation
  • none of the "higher" modes adds a life-saving functionality not found in a default mode.
  • one or more ability enhancing or quality of life functionalities are provided in a higher functionality mode.
  • At least two different default modes are provided, for example, for treating different conditions.
  • an aspect of some embodiments of the invention relates to providing an implant with a peripheral component outside the body.
  • the peripheral component provides data and/or instruction storage and/or power and/or CPU enhancement.
  • the peripheral component is secondary to the implant, for example, providing sensing and/or output capability and/or communication capability therefor, but optionally cannot provide therapy or sufficient therapy on its own.
  • the peripheral component is in the form factor of a control portion as described above.
  • sensing is provided for one or both of a physiological measure (e.g., acceleration, temperature, pH), environment (e.g., light level, pollution, noise, temperature) or UI (user interface).
  • a physiological measure e.g., acceleration, temperature, pH
  • environment e.g., light level, pollution, noise, temperature
  • UI user interface
  • output is human readable and/or machine readable.
  • providing a UI allows a user to interface with an implant. It is noted that a basic ability to interface is provided by the act of selecting which peripheral component (e.g., "sticker") to use with the implant.
  • more specific input for example, timing of triggering events and/or medicine ingestion, are provided via the UI.
  • the UI includes as an input a switch or pressure sensor.
  • the UI includes as an output one or more lights, a display and/or a speaker.
  • the provision of a UI is a functionality for which a user is charged.
  • the UI is used to allow the implant to interact with a user, for example, to provide advice thereat and/or to provide treatment data.
  • the device can provide solicited and/or unsolicited communications, for example "slow down” in case cardiac output goes up or "please consider avoiding applying therapy at this time” in response to a sticker application.
  • the UI is used to collect information from a user. For example, the UI can ask a user "how are you feeling" or "are you planning on sitting for the next 60 minutes" or "will you be doing your daily exercise".
  • the peripheral component and/or the implant use machine learning to learn a user's schedule and/or expected behavior after various events and/or various conditions.
  • the implant and/or the sticker associate one or more locations (e.g., GPS, for example, as provided by a linked cellular telephone or by a GPS receiver on the implant or using wireless station detection), with expected activities and/or a desired therapy.
  • location e.g., GPS, for example, as provided by a linked cellular telephone or by a GPS receiver on the implant or using wireless station detection
  • user input is used to generate the association between time and/or location and implant operation.
  • the component includes a wireless link, such as Bluetooth for communicating messages to a user's earphone or cellular telephone (or other portable device).
  • a wireless link such as Bluetooth for communicating messages to a user's earphone or cellular telephone (or other portable device).
  • microphone function is provided in a similar way and recorded sound sent by Bluetooth to the component.
  • the peripheral component e.g., a battery
  • the peripheral component functionality is drug release.
  • the peripheral component functionality is communication with a different device, for example, an insulin pump.
  • a GCM implant may generate a signal indicating stomach emptying event (or expected time), which the peripheral component sends to an insulin pump.
  • An aspect of some embodiments of the invention relates to using disposable components to control an implant or other medical device using methods commonly used for swallowed medications.
  • a set of stickers are provided wherein each sticker corresponds to the use of a swallowable pill, for example, defining a dosage unit of less than 24 hours, less than 12 hours, less than 6 hours and/or defining dosage unit or fraction thereof suitable for treating an acute event.
  • such stickers are used together with swallowed medicine (or other delivery methods, such as patch, injection or inhalation).
  • the user indicates the taking of medicine to the implant by attaching sticker to the skin adjacent the implant. This may prompt the implant to provide treatment and/or monitoring taking into account the ingestion of the medication.
  • the sticker itself does not cause any direct action by the implant. Rather, the sticker optionally changes the logic applied by the implant. For example, the sticker may change a mode of operation, indicate that certain decision points are to be ignored (or activated) and/or change a threshold. In some embodiments a set of logic operations, such as rules or programming code are provided by the sticker.
  • a size of a sticker encodes an effect.
  • a small sticker controls the implant to operate for a short time (and/or low amplitude) and a larger sticker controls the implant to be active for a longer time and/or amplitude).
  • a particular example is indicating meal size or glycemic effect thereof by selecting a suitable sticker size for attaching near/at an insulin pump.
  • the sticker has a helpful image, for example, indicating protein (e.g., showing a chicken), carbohydrates (e.g., showing an image of a loaf of bread) or fat (e.g., showing a slab of margarine).
  • the encoding by size may be used by a patient to select a desired result according to a severity of a symptom and be oblivious to the actual control applied on the implant.
  • a user can select a sticker to use according to a sensed symptom (e.g., pain, lack of breath) and/or an expected event (e.g., eating, exercise).
  • a sensed symptom e.g., pain, lack of breath
  • an expected event e.g., eating, exercise
  • An aspect of some embodiments of the invention relates to controlling an implant using a swallowable or otherwise internalized element, for example, in the form of a pill.
  • a swallowable or otherwise internalized element for example, in the form of a pill.
  • an implant senses the existence of the element and/or data transmitted therefrom and modifies it behavior accordingly.
  • the element is activated manually before insertion.
  • the element is self-activated by insertion.
  • a pill containing a moisture or pH activated circuit starts emitting RF radiation or acts as an RF transponder once ingested.
  • an implant near the stomach or an implant including an antenna near the stomach (or other relevant part of the GI tract) detects such signals and/or interrogates the element to receive data therefrom.
  • An aspect of some embodiments of the invention relates to improving compliance and/or patient satisfaction.
  • a patient is reimbursed for ineffective treatment, by the implant tracking and reporting a health effect of the treatment.
  • the reporting is via uploading of data to a sticker used to activate the implant.
  • charging of a client or refunding thereto is based on such reporting in stickers.
  • the implant can detect that treatment is needed and generates a report (e.g., to a sticker or a programmer) if treatment was not applied by a user as recommended.
  • a report e.g., to a sticker or a programmer
  • such report may include lack of consistency in application.
  • the user is queried (e.g., via a smartphone or programmer) as to reasons for lack of use, for example, side effects.
  • the implant and/or programmer are configured to detect non-use and offer financial and/or other incentives to the user, in response thereto.
  • Fig. 1 illustrates a stimulation system 100, in accordance with an exemplary embodiment of the invention.
  • system 100 includes an intrabody portion 102 (e.g., in dashed line optionally within a housing), an external portion 104 (e.g., in dashed line optionally within a housing) and an optional remote portion 106.
  • intrabody portion 102 includes one or more electrodes 110 which are attached or adjacent a target tissue and also includes an energy module 114, which collects energy supplied by external portion 104 and provides the energy to electrodes 110.
  • circuitry 112 mediates the transfer of energy.
  • temporary energy storage is provided in portion 102, for example in the form of a coil, capacitor, super capacitor or rechargeable battery.
  • the geometry of intrabody portion 102 may vary depending on implementation thereof, the form of an elongate flexible element is described below.
  • External portion 104 may include an adhesive layer for attachment to skin (not shown).
  • External portion 104 includes a power transmitter 120 and a power source 124, for example in the form of power storage (e.g., a battery). In use, transmitter 120 sends power from source 124 to intrabody portion 102.
  • a power source 124 for example in the form of power storage (e.g., a battery). In use, transmitter 120 sends power from source 124 to intrabody portion 102.
  • circuitry 126 is provided for controlling the delivery of power to transmitter 120.
  • Other optional and/or alternative functions are described herein as well.
  • a telemetry component 128, optionally integral with and/or controlled by circuitry 126, is used for outside communication, for example, to remote portion 106.
  • telemetry is wireless, for example, using NFC or Bluetooth communication or other RF type or magnetic coupling type communication.
  • other wireless protocols may be used, for example, light based, electricity based and/or acoustical.
  • a wired connector, such as USB plug is provided on external portion 104.
  • telemetry is used for one or more of programming the behavior of circuitry 126, downloading data logs and/or keeping track of the actual attachment of external portion to the body and application of signals thereby (e.g., to compare to an expected treatment profile).
  • one or more sensors 130 are provided in external portion 104.
  • Exemplary sensors include acceleration and temperature sensors.
  • such sensors are used to control stimulation delivery (e.g., according to patient activity, time of day, environments and/or posture).
  • measurements by the sensor(s) are logged and used for analysis after the fact.
  • a memory 132 optionally non-volatile, is provided, optionally a removable memory.
  • the memory has stored thereon instructions for controlling the stimulation.
  • the memory has stored thereon instructions for sensing, processing and/or collecting sense data from sensor 130 and/or intrabody portion 102.
  • the memory stores thereon a log of operation and/or unexpected events.
  • a display 134 is provided.
  • the display is a simple display, for example, one or more LED lights which indicate, for example, one or more of ongoing stimulation, need to replace power storage 124 and/or whole external portion 104 and/or an error condition of the device (e.g. of intrabody portion 102 and/or external portion 104) or a physiological problem of the patient.
  • two LEDs may be provided, one which indicates activity or need to change power source and one which indicates error of device or physiological condition.
  • display 134 includes pixelated and/or alpha numerical ability.
  • display 134 may be touch sensitive.
  • display 134 may be auditory, for example, generating sounds (e.g., speech or otherwise) or synthesized speech messages.
  • one or more input 136 is provided.
  • the input is used for human input, for example, comprising a button which is pressed to generate a display indicating power state.
  • input 136 is used for automated input, for example, for reading a command from a controller or for reading the identity of a tool brought in proximity to or contact with input 136.
  • an RFID reading mechanism is used.
  • external portion 104 is used to provide power to intrabody portion 102, optionally or alternatively, there are data communications between intrabody portions 102 and external portion 104.
  • modulation of sensitivity of energy collector 114 to transmitted/coupled energy from transmitter 120 is used to transmit data from intrabody portion 102 to external portion 104.
  • ID elements for example, an backscatter based RFID tag 116 modulates its reflection of energy transmitted to it by transmitter 120 or an ID module 122 (other paired mechanisms may be used as well, for example a magnet and a matching magnetic sensor).
  • ID transmission may be used to confirm (to intrabody portion 102) identity of and permission to work with an external portion 104, or vice versa.
  • a dedicated RF, sound, ultrasound, optical and/or other type of link is used, noting that a typically thin section of tissue between the intrabody portion and external portion would not disrupt a low power link by too much.
  • power is provided directly by external portion 104.
  • a dedicated battery optionally rechargeable, is provided in intrabody portion 102.
  • circuitry 126 which optionally controls senor 130 may provide analysis of sensed signals provided from intrabody portion 102.
  • power transmitter 120 may transmit sufficient power to intrabody portion 102 and for sufficient time, so as to turn on circuitry 112, sense signals and transmit back at least an indication of the signals.
  • some processing is carried out in intrabody portion 102.
  • processing is carried out in external portion 104 (e.g., circuitry 126).
  • processing comprises pattern matching of a sensed signal to situations such as "stimulate”, “physiological state X", “do not stimulate” and "activity of a therapeutic device” (e.g., to detect pacing by a pacemaker).
  • processing comprises after pattern matching and/or recognition, further processing to extract one or more physiological indicators.
  • the type of processing carried out depends on the programming and/or circuitry of external portion 104.
  • a user is presented with a range of different external portions, each one with different processing logic.
  • one or more safety features are provided, for example, ensuring that the external portion is matched to a correct internal portion, avoiding treatment during inappropriate and/or dangerous physiological states and/or avoid over dosing.
  • external portion 104 when providing and/or programming external portion 104, it is associated with a code that is recognized by and/or expected to match a code in intrabody portion 102.
  • intrabody portion 102 includes a gate circuit (e.g., a transistor or relay) which prevents current from advancing to electrode(s) 110 unless an authorizing signal is provided.
  • Such a safety mechanism may also prevent inadvertent stimulation caused by other sources of energy transmission.
  • the command to stimulate is digitally signed and acted upon only if the signature is correct and/or matched the code of the intrabody portion.
  • other commands such as "sense” and "report log” may also be protected, for example, to enhance patient privacy, e.g., by preventing data from exiting the intrabody portion absent authorization.
  • the authorization is provided via a separate channel, at least in part, from the power.
  • circuitry 112 may be programmed to reject certain commands and/or sequences, for example, certain power levels and/or timing ranges. In some embodiments, circuitry 112 limits application by cutting short an ongoing stimulation sequence (e.g., by sending a request to external portion 104 and/or by blocking propagation of power to electrode(s) 110).
  • a separate programming command (e.g., provided by a physician) may be used to release and/or change such a limitation. In an exemplary embodiment of the invention, this is used to prevent a patient from accidentally overdosing himself. In some embodiments, there is a hand-shaking between external portions 104 that are used sequentially, for example, via controller 140, so that the currently active external portion (or a programmer) can be made aware of the previous treatments applied.
  • intrabody portion 102 reports its ID number and/or other identifying information to the external portion 104, for example, for use in logging activity and/or to (help) circuitry 126 limit application of power and/or commands to intrabody portion 102.
  • Fig. 1 Also shown in Fig. 1 is an optional packaging method, whereby a package 108 including a plurality of external portions 104 is provided to a patient, generally with instruction for use.
  • portions 104 are in the form of patches and/or have printed thereon instructions for use (e.g., use at night).
  • a remote portion 106 may include a local controller 140 (e.g., a cellular phone or other computer with an appropriate programming) which optionally connects to a remote server 144 (or a cloud service) over a communication network 142.
  • Controller 140 may be used, for example, to read and/or program external section 104 and/or to provide data to remote server 144 and/or suggest new treatment parameters.
  • controller 140 is used to allow communication with a caregiver, for example, to provide such a caregiver with alerts.
  • the use of a cellular telephone for controller 140 is useful as many people carry a cellular telephone and this make it likely that controller 140 will be within wireless range of telemetry component 128.
  • external portion 104 includes one, two, three or more of the following features (two or more of which may be provided as a single module):
  • processing circuitry for example, using template recognition to classify sensed signals into various physiological states and/or identify timing reference points for calculating timing to apply a signal.
  • template recognition is provided for one or more of ECG, EGG and EEG.
  • template recognition is used on other sensed data, for example, on data from an acceleration sensor which may be part of the external portion;
  • memory for data logging, for example, for logging sensed data on the patient, for logging activity of the patient and/or for logging activity of the device;
  • communication circuitry for communicating with a mobile device (e.g. Bluetooth);
  • communication circuitry for communicating with a disease management center and/or server (optionally using a cellphone as a gateway, or using a dedicated radio);
  • communication circuitry for communicating with medical staff (e.g, a doctor and/or nurse or other caregiver), optionally using a cellphone as a gateway, or using a dedicated radio;
  • each external portion is programmed for certain amount and/or type of use (e.g. a number of days or stimulations or time from first activity) and will not operate after its designated use occurred.
  • the indicator is chemical, with a color changing as the external portion ages.
  • the indicator shows a voltage or charge level of the power supply.
  • the indicator comprises circuitry which sends one or more messages (e.g., by wireless, e.g., Bluetooth, SMS or voice message) when replacement or other attention is needed.
  • a patient is implanted with multiple intrabody portions 102 (for example, as part of a multi-point or multi-organ treatment).
  • two external portions can coordinate their activities with each other.
  • a first external portion can be programmed to send a command to a second external portion indicating when the first portion has stimulated and/or when the second external portion should stimulate and/or results of a sensing by the first external portion/intrabody portion.
  • an external portion is used as a clock and/or as a command center for a plurality of other external portions.
  • such an external portion is attached not in conjunction with an intrabody portion.
  • coordination is provided by a controller 140, such as a cellphone.
  • FIG. 2 is a block diagram showing an alternative stimulation system 200 in accordance with an exemplary embodiment of the invention.
  • FIG. 2 is a block diagram showing an alternative stimulation system 200 in accordance with an exemplary embodiment of the invention.
  • each of Figs. 1-3 shows a different conceptual design for a system.
  • features described in conjunction with one design may be used with a different design and, for brevity, will generally not be repeated.
  • the choice which design to use will dependent on a tradeoff of costs and convenience, as some designs have cheaper intrabody portions, some have cheaper external portions.
  • the ease of use and/or functional (e.g., quality of data transmission and/or ability to sense) ability may differ between designs.
  • the intrabody portion is a complete system (e.g., pacemaker) with sufficient power and/or processing ability, and the external portion is used to provide additional commands, modulation and/or dosing instructions.
  • a complete system e.g., pacemaker
  • the external portion is used to provide additional commands, modulation and/or dosing instructions.
  • System 200 can be generally the same as system 100, except that intrabody portion 202 has less complex and/or less circuitry than intrabody portion 102, with the difference being compensated for by added functionality in external portion 204 (e.g., vs. external portion 104). For example, in one embodiment, all of the components except for circuitry 112 and 126 are the same. In some embodiments, a single external portion 204 is designed to work with either of internal portions 102 and 102. In some exemplary embodiments of the invention, analog circuitry 206, for example, provided as a separate component or integral with circuitry 126, provide analog processing, so as to minimize processing by a transducer 208, which converts the received signal into a stimulation pulse.
  • analog circuitry 206 for example, provided as a separate component or integral with circuitry 126, provide analog processing, so as to minimize processing by a transducer 208, which converts the received signal into a stimulation pulse.
  • analog circuitry 206 shapes the power signal to be sent to intrabody portion 202 so as to have a desired stimulation effect.
  • intrabody portion 102 would use circuitry to generate a pulse signal, using the power provided by circuitry 126 (e.g., temporarily storing the transmitted power and then releasing it in a desired signal form and/or timing).
  • circuitry 112 might be expected to process the signal more than would transducer 208.
  • circuitry 112 might provide a/d conversion and/or encoding, while transducer 208 would only provide modulation which can be detected by transmitter 120.
  • transmitter 120 may act as or be provided along with a receiver.
  • system 100 and system 200 are often a matter of degree. It is noted that a system with a different tradeoff may be used as well, for example, a system where most of the processing and/or control are provided in the intrabody portion and only a small part and/or only power provided by the external portion. In some cases, communication bandwidth limitations between the intrabody and external components may dictate which distribution of functionalities to use. Some examples for signal generation follow, two or more of which may be provided in a same system (e.g., 100/200).
  • intrabody portion 102 generates a signal to external portion 104 when power is needed.
  • external portion 204 sends power (e.g., periodically) and intrabody portion 202 generates a response if more power is needed and/or if to stop sending power.
  • power sending follows a timed protocol.
  • external portion 204 sends power, e.g., enough to do sensing and/or processing and then sends more power (e.g., sufficient for stimulation), at a time delay and if not requested otherwise by intrabody portion 102.
  • a request may be made to send more power and/or a larger number of power pulses.
  • the request may include, for example, one or more of amplitude, number, duration and/or other timing information.
  • a request to stop sending power is provided during the transmission of a power pulse.
  • some small amount of power is transmitted to allow for orderly shutdown of the intrabody portion (e.g., store register value in a non-volatile memory unit).
  • the sequence includes more than two power pulses (e.g., including a pulse of power to enable processing and/or more than one stimulation pulse).
  • the amount of power sent may be, for example, monotonically increasing.
  • a small amount of background power is sent continuously or periodically, for example, to support sensing. As a result of the sensing, additional power may be requested by the inner portion and/or pushed by the external portion.
  • external portion 104 also sends commands (e.g., "sense”, “stimulate using program #1"), which are decoded and/or carried out by intrabody portion 102.
  • commands e.g., "sense”, "stimulate using program #1
  • intrabody portion 102 For system 204, optionally, no commands are sent.
  • external portion 104 sends power and intrabody portion 102 modulates its received power, e.g., by chopping and/or ignoring some of the power, so as to provide a pulse shape as desired.
  • such shaping is optionally performed by circuitry 206 and/or circuitry 126.
  • FIG. 3 is a block diagram showing another alternative stimulation system 300 in accordance with an exemplary embodiment of the invention, in which at least one component 314 is used to modulate the behavior of external portion 304.
  • internal portion 302 and external portion 304 may be any of the designs described herein, except that a reader 310 is provided in external portion 304 (or its functionality provided by existing components such as 126, 128), to communicate with component 314.
  • a connector 312, for example a spring connector, magnetic connector, snap/interference connector and/or magnetic connector holds and/or electrically interconnects component 314 to reader 310 and/or other parts of external portion 304.
  • component 314 is used to provide control and/or for a session of therapy and/or sensing.
  • component 314 is the equivalent of a pill and may be used to provide a single stimulation session (e.g., morning stimulations or 2 stimulation pulse sequences).
  • component 314 defines the dose to be applied. For example, one component may be "low dose” and another be “high dose”. Components may be color coded accordingly. In one example, a patient is told to use the blue “pill” first and if this fails, to use the "pink” pill. Unlike medication, however, circuitry 126 can be set up to prevent inadvertent over dosing, by avoiding stimulating until acceptable to do so.
  • circuitry can delay application of a stimulation (or sensing) for another reason, for example, to ensure it is done while sleeping (e.g., using an accelerometer sensor to detect sleep) and/or after exercise or eating, at a time delay (e.g., using an internal clock), in synchronization with oral dosing (e.g., requiring patient input or input from a cellular telephone, e.g., with a cellular telephone acting as a user interface to external portion 304) and/or according to a physiological state of the patent and/or target tissue.
  • a stimulation for reducing blood pressure may be delayed or prevented if blood pressure is sensed or estimated to be already low so that further lowering might cause syncope.
  • Such considerations may be, for example, programmed into component 314 and/or external portion 304.
  • external portion 304 includes locations (e.g., sockets or connectors) for multiple components.
  • external portion 304 need not apply the components in an additive manner. Rather, the combination of two components may be different form merely applying the programming of the two components.
  • one component serves to modulate the other component (e.g., amplitude, timing and/or application logic).
  • one component defines the condition to be detected and another component defines the treatment to be applied.
  • the component comprises circuitry which is used by external portion 314.
  • component 314 comprises memory which is read by external portion 304.
  • component 314 comprises a sensor or communication ability used by external portion 304.
  • component 314 comprises a power source used by external portion 304, optionally using only that power for stimulation of the target tissue.
  • component 314 provides processing circuitry and/or other circuitry instead of circuitry 126.
  • components 314 are provided in a blister pack or other pack 316, possibly mimicking pills in size and/or shape.
  • component 314 may be in a flat form, such as a patch. This may mimic treatments where a patient applies a skin patch (in this case to external portion 304, not to skin).
  • power supplies (124) or enhanced power supplies (124+) which may include circuitry as well are provided in this or other embodiments as a replaceable element, optionally in a pack 318.
  • one replaceable layer may be a power source 124 or power source and circuitry 124+ and a next layer (electrically alignable therewith) being a component 314.
  • external portion 314 includes one or more pins for aligning the various layers.
  • component 314 includes two or more external electrical contacts.
  • External portion 304 optionally includes two or more matching electrodes on its outer surface.
  • indicator/display 134 is used to indicate if a component 314 was used, should be replaced and/or was not activated yet (e.g., due to a delay logic such as described above).
  • an audible indication is provided to the patient.
  • FIG. 4 is a showing of a stimulation system 400 based on the design of Fig. 1, in accordance with an exemplary embodiment of the invention.
  • An intrabody portion 402 is in the form of an elongate flexible lead/body 403, having, for example, bi-polar double helix screw in electrode(s) 410 for stimulation.
  • Other numbers and/or types of stimulation electrodes may be provided in addition or instead, in some embodiments of the invention.
  • one or more sensing electrodes 417 (local) and/or 415 (remote) are used, for example, for impedance sensing (e.g. to tell a state of filling of a stomach).
  • a stimulation and sensing circuitry 413 is optionally provided near the distal (electrode) end, and may control the impedance electrodes and/or process/receive signals sensed by electrodes 410 (e.g., local gastric activity).
  • an antenna 414 is used as an energy collector. While a whip antenna is shown, other antenna designs can be used, for example, coil antenna, self-expanding antenna (e.g., space filling or with a 3D shape such as a sphere surface or cylinder wall) and/or unfolding (optionally planar) antenna.
  • the antenna is configured to self expand strongly enough so that it can cut through or push aside fat tissue or connective tissue between tissue layers, near the skin.
  • the power receiving and/or communication circuitry (411) is separate from sensing circuitry 413.
  • An external portion 404 may be, for example, in the form of a flat adhesive pad (e.g., a battery with an adhesive layer) with an electronics package thereon.
  • a flat adhesive pad e.g., a battery with an adhesive layer
  • a cellular phone 406 which may have an "app" installed thereon, is optionally used to control and/or program and/or monitor and/or read external component 404.
  • a dedicated controller or a computer appliance e.g., with a USB communication and/or control stick
  • external portion 404 is between 0.1 and 30 mm or more thick, for example, between 3 and 11 mm thick. In an exemplary embodiment of the invention, its maximal extent is between 30 and 200 mm or more, for example, between 50 and 150 mm.
  • at least 50% of the surface of external portion 404 is flexible and/or has other material properties so that it can stay mounted on a soft body part such as an abdomen or a chest. It is noted that other geometries and/or sizes may be provided as well.
  • component 314, if pill-like, is between 3 and 40 or more mm in length and between 3 and 30 mm or more in width and/or thickness.
  • component 314, if flat, has a geometry within the parameters described for external portion 404. It is noted that other geometries and/or sizes may be provided as well.
  • intrabody portion 402 is between 10 and 450 mm or more long, for example, between 100 and 300 mm long.
  • the body is, at least over 80% of a length thereof flexible and has a small maximal diameter, such as between 0.2 and 5 mm, for example, between 0.5 and 2.1 mm.
  • one or more or all of the thickenings are up to less than 500% of the thickness of body 403 and/or up to less than 5 mm or 10 mm or more in maximal diameter (e.g., when deployed).
  • body 403 is made of and/or covered with a biocompatible material suitable for long term implantation.
  • the material is chosen (e.g., softness, flexibility) so as to prevent accidental damage to nearby tissue when body 403 moves relative thereto.
  • body 403 is made of a material which does not adhere to tissue over time, for example, to assist in removal thereof.
  • intrabody portion 420 is designed to need up to 250mWh/week, and external portion 404 to be able to provide such power for up to 7 days.
  • external portion 404 may be designed to provide between 10 and 3000 mWh or more, for example, between 100 and 500 mWh.
  • FIG. 5 shows an exemplary delivery system 500 for intrabody portion 402 (or other elongate such portion), in accordance with an exemplary embodiment of the invention.
  • a needle 502 optionally having a sharp tip 504 carries portion 402 therein.
  • an optional stylet screwdriver 506 (or other attaching control mechanism, for example, as known in the art of lead implantation) is used to screw electrodes 410 into the target organ.
  • a base 510 for engaging and receiving rotation of a head 508 of screwdriver 506.
  • Needle 502 may be rigid or flexible and/or may be replaced by a tube such as a catheter, endoscope and/or laparoscope.
  • intrabody portion 402 may lie in a vein with electrode 410 screwed into the heart and antenna 414 being outside the vein (e.g., implanted as would a pacemaker lead).
  • needle 502 includes a marker 528, for example, visible under x-ray and/or ultrasonic imaging, to assist in guiding the needle to a target tissue.
  • a marker 528 for example, visible under x-ray and/or ultrasonic imaging
  • needle 52 has mounted thereon an imager 526 or other sensor, for example, optical or ultrasonic sensor to assist in determining when the target tissue is reached.
  • imager 526 or other sensor, for example, optical or ultrasonic sensor to assist in determining when the target tissue is reached.
  • the target tissue is illuminated (e.g., using light or ultrasound) to guide the needle.
  • a tool 520 may be suitable for insertion into a stomach and include a power source 522 and a light (or ultrasound) emitting tip 514.
  • Sensor 526 may detect the signal form tip 524.
  • the needle is guided to a target tissue and then intrabody portion 402 is inserted therein.
  • needle 502 may have an insert 530 inserted therein, which has an elongate body 532, a sensor or light guide 536 and a display 534 which is arranged to be outside the body.
  • Wireless means may be used as well. Also, other methods of navigating needles in the body, for example, as may be known in the art, may be used.
  • FIG. 6 shows the system of Fig. 4 implanted in a stomach 600, in accordance with an exemplary embodiment of the invention.
  • the electrodes 110 may be attached at a location 602 such as used for strengthening stomach contractions (e.g., as used in the Tantalus device, by Metacure Ltd.).
  • all of intrabody portion 402 is under skin 604, for example, between 0.1 and 1 cm or more under the skin.
  • the system may include a stimulation circuit which is set to apply power to target tissue(s) including a modulation power, a modification power, an activation power, a deactivation power, an organ or sub organ opening effect power, an organ or sub organ closing effect power, an irritation power and/or the like.
  • FIG. 7 is a pulse diagram showing a pulse sequence, in accordance with an exemplary embodiment of the invention, which may be used, for example, for treating obesity and/or high glucose levels, when attached to a location within a few cm from the stomach pylorus.
  • other pulse sequences may be used as well and/or applied to other organs and/or used for treating other conditions.
  • FIG. 8 is a detailed block diagram showing the distribution of electronic components inside and outside the body, in an exemplary system according to Fig. 4.
  • a GCM pulse generator 812 (e.g., for gastric stimulation) which is attached to two electrodes 810. These electrodes are also attached e.g., via high impedance isolators 818, 820, for sensing.
  • a circuit 816 may be used to detect local activation time.
  • An impedance signal may be measured using synchronization with an injected current/voltage injected via auxiliary electrodes 828 using a generator 826.
  • Circuitry 814 may be used to receive the power from outside the body and pass it to, for example, GCM pulse generator 812 and/or processing circuitry, and/or to send sensed signals outside the body, e.g., via an energy collector using circuitry 822 and an antenna 821.
  • a power transmitter including a transmitter circuit 832 and an antenna 834 (e.g., a flat coil), which transfer power from a power source 836.
  • a communication module 830 is shown as both handling data communications with intrabody portion 802 (e.g., via the transmitter circuit 832) and also handling telemetry (e.g., to a controller 842).
  • a microcontroller 840 or other control and/or processing circuitry is shown as controlling and/or receiving communication and also receiving signals, for example form an accelerometer 838.
  • an app 844 (e.g., or other software form) is used for configuring a cellular telephone 842 to act as a controller.
  • FIG. 9 is a cross-sectional view of an external portion 900 of an exemplary system according to Fig. 1 and/or other embodiments of the invention.
  • a layer with adhesive 902 is at the bottom of portion 900.
  • a housing 910 is shown sealing the internal components and may include one or more contacts thereon.
  • An antenna 904 for transmitting energy into the body is shown.
  • An electronics package optionally in the form of a single ASIC 906, is shown which optionally provides all electronic circuitry needs.
  • the volume of battery 908 is between 0.2 cubic cm and 27 cubic cm or more, for example, between 2 and 10 cubic cm.
  • an edge of adhesive layer 902 is non adhesive and acts (and/or is formed) as a tab to peel external portion 900 off the body.
  • layer 902 has a marking thereon so a user can align it with a marking used to indicate the position at which external portion is to be attached (e.g., to improve power coupling between the intrabody and external portions).
  • FIG. 10 is a flowchart of an operation of an implanted system (e.g., of Figs. 1-4), in accordance with some exemplary embodiments of the invention.
  • power is sent from the external portion to a sensing circuit in the intrabody portion.
  • power may be sent, for example continuously or periodically.
  • power may be sent in response to an event, such as sensed by the external portion or due to user or remote command.
  • the power is received by the sensor in the intrabody portion.
  • the power may be used, for example, to power the sensor, power processing circuitry and/or power an injected signal (e.g., impedance).
  • the duration of power transmission is selected to enable the sensing to be completed and its results and transmitted.
  • the senor transmits a sensed signal or an indication thereof (e.g., based on an amount of processing in the intrabody portion) to the external portion.
  • the sensor signal is received in the external portion. It is noted that as the sensing is initiated by the external portion various methods of synchronous detection may be used. Optionally or alternatively, backscatter methods may be used, with the sensor modifying a backscatter property of part of the intrabody portion and the external portion knowing to interrogate the intrabody portion based on the above known initiation thereby.
  • the received signal is processed, for example, by template matching.
  • the external portion optionally applies a logic (e.g., rules or pattern matching or code) to determine if and when and what treatment to apply.
  • a logic e.g., rules or pattern matching or code
  • the external portion optionally applies a logic (e.g., rules or pattern matching or code) to determine what dosage and/or regime to apply.
  • a logic e.g., rules or pattern matching or code
  • an optional unlock signal is sent to the intrabody portion, so that stimulation will be allowed.
  • stimulation power optionally already shaped (envelope and/or temporal intervals) according to desired treatment, is sent to the intrabody portion.
  • the activity is optionally logged. Logging may be alternatively or additionally applied to other acts of the system and/or patient.
  • an instruction to apply stimulation is provided to the intrabody portion from the external portion.
  • the intrabody portion receives the power, command and/or unlock instructions, as relevant.
  • the intrabody portion conveys the power to the electrodes for applying the stimulation. Some power may be diverted to local processing and/or sensing.
  • the intrabody portion may send a request to stop power or provide more power and/or otherwise modify power transmission.
  • the intrabody portion may send feedback on the effect of treatment (e.g., via sensing).
  • FIG. 11 is a flowchart of a method of using an implanted system according to some exemplary embodiments of the invention.
  • an intrabody portion is implanted (e.g., as described below with reference to Fig. 13.
  • a need is determined.
  • a need can be acute (e.g., nausea, high blood pressure attack, low cardiac output and/or lung edema) or ongoing (e.g., chronic heart failure, chronic high blood pressure and/or obesity).
  • a particular advantage of some embodiments of the invention is that a simple way to control timing and dosing of treatment is provided.
  • a headache where the patient would take two aspirin
  • electrically mediated treatments a patient can decide that treatment is desired, how much treatment to apply and if treatment was effective.
  • an external portion (and/or a component 314) is attached over the intrabody portion, for example, by being aligned with a marking, such as made using a permanent marker, on the patient's skin.
  • a marking such as made using a permanent marker
  • magnetic alignment e.g., with an implanted magnet or magnetic material such as iron
  • the external portion causes a stimulation of the body by transmitting power and/or control signals to the intrabody portion. While the application has focused on electrical stimulation, other types of stimulation can be provided as well or instead, for example, drug release (at the distal tip) and mechanical or light or RF stimulation (e.g., with a suitable transducer instead of electrodes 110).
  • actual stimulation is, in some cases, stimulated by the user and/or based on a sensed signal.
  • the external portion (or component 314) is removed.
  • data is optionally uploaded from the external portion (and/or component 314) to a computer, for example, while attached to the body or after removal.
  • external portions are provided in pack of, for example, between 3 and 50 units or more, for example, suitable for a month of treatment or for a course of treatment.
  • Components 314 may be provided in packs of, for example, between 3 and 100 components or more, for example, between 15 and 45 components.
  • FIG. 12 is a flowchart of a method of treating a patient using an implanted system according to some exemplary embodiments of the invention.
  • a patient need is determined, for example by a physician.
  • the patient is sent for implantation (e.g., as described in Fig. 13).
  • the implantation is cheap or free, for example, less than $1000, possibly just covering manpower expenses.
  • the intrabody portion is small and/or cheap.
  • patient response to various treatments are optionally checked. This allows to calibrate delivered signals to actual effects.
  • a physician prescribes treatment and/or a sensing regimen and/or treatment to be applied at a patient's discretion.
  • the physician uses a vendor supplied software to correlate desired effects with desired treatment regimes and desired/possible packaging of treatment as external portions and/or components 314.
  • prescribed treatment may depend on a desire of the physician for feedback and/or control and/or patient ability to handle technology of various types.
  • pricing is determined for the treatment, for example, based on the disease, the expected number of treatments and/or actual cost of treatment components.
  • any profit is made on the disposable components, rather than implantation procedure (which, may be simple or even outpatient).
  • the major (cumulative) part of the cost of the system sits outside the body of a patient.
  • an effect of treatment and/or sensing results are tracked, for example, using a computer at a remote service location or in the cloud.
  • a computer or service center may use software to determine if the treatment is effective and/or cost effective. Such determination may be reported to a treating physician and/or a payer.
  • tracking is by physician visit.
  • the physician or other caregiver or person/computer involved in the therapy
  • such reporting is via a user device, such as a cellphone, which receives a remote command form the physician and activates the system by command and sends extracted data to the physician.
  • the physician may try out certain treatments by remote and expect immediate feedback from the patient.
  • a new prescription is provided based on the tracking, if needed.
  • the actual provision of the disposable components may be, for example, at a pharmacy or by mail order.
  • a programmer device e.g., computer
  • the disposables programs the disposables as needed, for example, using data from a service center, such as including one or more of patient information, implant id and desired treatment.
  • the disposables at least in part, are standard components and do not require any programming.
  • some programming may be provided by a controller, for example, a user or physician cellular telephone or portable computer.
  • the disposables are programmed while sealed in a box. In some embodiments, the disposables include only power, so less or no personalization is needed.
  • treatment may be stopped for various reasons, possibly also with the intrabody portion removed (e.g., by detaching all or part of the portion from the target tissue and retracting).
  • the intrabody portion when retracted with sufficient force or jerk disconnects from electrodes 110, with electrode 110 remaining in the body.
  • the intrabody portion is unscrewed form the tissue.
  • FIG. 13 is a flowchart of a method of implanting a system, for example of Fig. 4, in accordance with some exemplary embodiments of the invention.
  • a target tissue is selected. While Fig. 4 has focused in the stomach, other tissue may be targeted instead, for example, the brain (e.g., for DBS), heart (e.g., pacing, anti- arrhythmia control and/or contractility enhancement), stomach (nausea, obesity and/or diabetes), pancreas (e.g., for glucose control and/or exocrine secretions), uterus (e.g.
  • the brain e.g., for DBS
  • heart e.g., pacing, anti- arrhythmia control and/or contractility enhancement
  • stomach nausea, obesity and/or diabetes
  • pancreas e.g., for glucose control and/or exocrine secretions
  • uterus e.g.
  • bladder e.g., for releasing contents and/or preventing release
  • muscle e.g., for physiotherapy and/or sphincter control and/or diaphragm control and/or for other muscle stimulations
  • nervous tissue e.g., vagal nerve and other nerve or ganglion stimulation and/or for pain treatment (e.g., in spine)
  • nerve tissue e.g., vagal nerve and other nerve or ganglion stimulation and/or for pain treatment (e.g., in spine)
  • nerve tissue e.g., vagal nerve and other nerve or ganglion stimulation and/or for pain treatment (e.g., in spine)
  • excitable tissue or tissue which can be affected by treatment provided by an intrabody portion.
  • the needle (or a flexible probe) is inserted into the body, for example, via the skin.
  • the target organ is detected, optionally with the aid of intra-organ illumination, for example, provided to a location adjacent the desired target attachment point.
  • the needle is advanced and/or navigated to its target, optionally between or through tissue and/or inside a body conduit, such as a blood vessel.
  • the needle did not have the intrabody portion therein, it is loaded.
  • the intrabody portion is optionally attached to the target tissue, for example, using a suture or clip or by screwing in a helical electrode.
  • the needle is optionally retracted most of the way.
  • the needle is optionally further retracted, releasing the energy collector under the skin.
  • the energy collect self expands and/or anchors under the skin.
  • the needle is completely removed from the body.
  • the location for attachment of the external portion is optionally marked.
  • Fig. 14 is a schematic of a system 1400 using one or more accounts to manage a device functionality, in accordance with some exemplary embodiments of the invention.
  • An implant 1402 for example an IPG such as an ICD or a pacemaker can communicate with a charger or data communicator 1404 having an account 1406 thereon.
  • implant 1402 is physically able to provide various functionalities, however, there is a logic lock which prevents one or more functionalities from being applied, absent permission, which may be supplied by account 1406.
  • an account e.g., additional or alternative
  • data communicator 1404 is in the form of a sticker which is attached near the implant to allow it to operate.
  • data communicator 1404 is a smart card which may be swiped at the implant (or at an antenna near a body surface, associated with the implant).
  • communicator 1404 is activatable.
  • swiping at the implant transfers an account amount to the implant.
  • a charger or other controller 1404 is provided, which may be loaded using one or more payment elements 1408 (e.g., smart cards).
  • a payment element includes one or more account 1410 thereon.
  • Such an account may be general or may be linked to a particular type of functionality and/or may include a fixed or a variable amount of units therein.
  • payment elements 1408 and 1408' are examples of data carrying components which may carry data, such as device settings, other than or in addition to authorizations.
  • implant 1402 is controlled by charger/controller 1404 and the payment elements are used only to recharge it.
  • system 1400 includes accounts for one or more of power, data upload, data download, program, data logging, diagnosis functions and/or therapy functions.
  • power is stored at the implanted device, though its activation is external (e.g., through a sticker including credit).
  • credit may be reloaded from a wireless card or a new sticker may be purchased.
  • an implantable device is sold at some nominal price, well below its normal selling price.
  • the patient or third-party payer - for example, insurance
  • the therapy would be sold through stickers.
  • system 1400 and in particular implant 1402 provide at least life saving functionality even if the accounts are empty.
  • implant 1402 is a CRT-D system and if the accounts are empty, the CRT therapy (which generally less life-saving and more related to quality of life) is disabled or reduced in quantity and/or quality, but ICD function (which is life saving) is maintained.
  • applying a therapy by the implant in response to data/commands from an external control component may or may not involve actual application. Rather, the authorizations may be utilized to allow the implant to apply a therapy and/or certain therapy parameters if needed. In some embodiments, for example relating to payment, authorization may be consumed only if the implant is actually active. In some embodiments, however, even the act of allowing the implant to act, absent any acting, consumes at least some authorization(s).
  • the system is used in a pay- per-use mode.
  • each use of the system e.g., time unit, number of therapy sessions applied, number of events treated (e.g., meals, exercise, pain, symptom occurrence) and/or amount of data collected
  • reduces the account balance e.g., of a general account or a functionality-associated account.
  • the functionality is blocked and/or reduced in amount and/or quality application (e.g., one or more of the therapy being applied with/for less time, reduced power efficiency, increased side effects, reduced intensity, reduced spatial coverage (e.g., fewer painful areas treated), reduced accuracy, reduced selectivity/resolution, reduced logging, slower response and/or reduced UI functionality and/or fewer available parameters).
  • amount and/or quality application e.g., one or more of the therapy being applied with/for less time, reduced power efficiency, increased side effects, reduced intensity, reduced spatial coverage (e.g., fewer painful areas treated), reduced accuracy, reduced selectivity/resolution, reduced logging, slower response and/or reduced UI functionality and/or fewer available parameters.
  • the accounting is performed in an external controller and that controller (possibly in the form of a simple sticker) sends control (or authorization) signals to implant 1402, optionally in response to requests for authorization by implant 1402.
  • controller possibly in the form of a simple sticker
  • implant 1402 is sold at a nominal price, possibly well below its normal selling price.
  • the patient or third-party payer - for example, insurance
  • the payment is on a periodic basis (e.g. once a month) and used to allow continuous therapy.
  • the therapy is sold through stickers, whereby a unit of credit is debited each time the implant is used.
  • the presence of credit on the sticker verifies to the implant that therapy can be delivered. As time passes and therapy is delivered, the credit availability on the sticker decreases. Once credit reaches zero or some other threshold, the implantable device stops delivering therapy until a new sticker with credit is applied to the skin.
  • the sticker is identified and causes an account on the implant to be updated (a single time per sticker id).
  • This account is then optionally decreased as authorizations are consumed.
  • the amount of credit in an account or the existence of an account is used as a "status of the account”.
  • a charger or other controller is provided to allow a user to read the balance on a sticker.
  • NFC or other cell-phone linking technologies are used and allow a user to read a balance on the sticker.
  • a sticker is good for a time period (e.g., a certain month), and expires when the calendar month is over. In some cases, the sticker is for a certain therapy or time of day or trigger and does not expire.
  • the sticker includes a chemical which slowly oxidizes or otherwise changes when exposed to ambient and a user can see this change and determine when the sticker is expired.
  • an electrochemical reaction in which electrical current through a part of the component causes or encourages chemical change, for example, oxidation or decomposition or color change.
  • chemical change for example, oxidation or decomposition or color change.
  • the color change is parented to give a meaningful signal such as the word "expired”. Additional details which may be implemented in some embodiments of the invention, are described below.
  • the sticker is electronically active, for example, including counter or a clock which deactivates the card and/or reduces functionality that the card can authorize, over time or uses.
  • the card includes a user interface, such as a button, whereby a user can selectively activate implant 1402 by pressing the button or charge implant 1402 with one or more credits thereby.
  • the card includes a feedback mechanism, such as a speaker, which generates audible feedback on the credit transfer process, optionally notifying "empty” if pressing the button does not transfer any credit to the implant.
  • an account in implant 1402 is directly loaded by a payment element 1408 or a cellphone (or other portable or wired electronic device) with NFC or other short-range wireless communication protocol.
  • a card 1408 is sold (or provided by insurance) to the patient.
  • Card 1408 is placed in proximity to implant 1402 (or charger/controller/programmer 1404, in some embodiments), and implant 1402 reads its internal information (e.g., account 1410) to reload credit within the implant 1402 (e.g., an account 1406' therein).
  • the same operation would deduct the credit from the card.
  • the constant presence of card 1408 (or a sticker) is not needed to achieve the desired pay-per-use or controlled usage performance of the implant 1402.
  • card 1408 carries one or more encoded one time tokens, and implant 1402 does not allow reuse of a token, so card 1408 can be read only.
  • card 1408 is a short-term activated card, for example, including battery with short life or including component damaged by exposure to ambient. This allows a card to be inactive, be activated (e.g., by opening a seal) so as to charge implant 1402 or charger 1404 with uses and then expire so that the card is not reused on other implants.
  • a card 1408 when it first communicates with an implant is paired with that implant, for example, by writing an implant code in a non-erasable memory of the card. Thereafter, any transmission of the card includes the implant code and data from the card. This may prevent use of the card (or other control component, such as a sticker) with more than one implant.
  • a particular use where it may be desirable to have a card work with two (or more) implants is where a patient has multiple implants and a single card is used to provide data and/or instructions for a plurality of such implants and/or provide same information (e.g., patient weight) to two or more implants.
  • a card may include a limited number of implant code storage locations, optionally with a limitation that it only work with implants that are different from each other in type.
  • a same card may include pairs of implant codes and implant data/commands and send the data/commands according to an implant code received by the card.
  • a card or other control component sends data in a tagged format, such as XML, so as to allow implants to read the data and recognize relevant for their operation.
  • a card or other control component sends data in a tagged format, such as XML, so as to allow implants to read the data and recognize relevant for their operation.
  • This may also allow more general programming or programming a card with multiple alternatives. This may be useful, for example, if a card is designated as used or a particular therapy, but it may be unknown at the time of card preparation which of a plurality of different implant models and/or abilities it will be used with. Loading such a card with multiple alternatives may simplify sales and/or distribution thereof.
  • the accounts are substantially unlimited in capacity.
  • one or more of the accounts are limited.
  • the implant may be limited in number of uses or time of activation which it can store. This may be used to enforce periodic checkups and/or other contact with a health care provider (e.g., once a month or quarterly or annually).
  • a user can unload functionalities (e.g., account credits) from an implant 1402 to a charger 1404, for example, for reimbursement or for transfer to a different implant, optionally in a different patient.
  • functionalities e.g., account credits
  • implant 1402 has a sleep mode, whereby the implant stops looking for stickers to read after a period where no external control component is provided. For example, such reading may stop after 1-7 days, 1-3 weeks or 1-2 months or intermediate periods. This may save battery power.
  • the implant may be woken up again to, for example periodically, listen for external control signals.
  • such waking up is by using strong external magnetic field which interacts with a reed (or other) switch in the implant or by using a programmer device.
  • a device resetting sticker is provided to reset the device, instead of using a magnetic field, if desired.
  • any programming requires two stickers, one which is an authentication sticker (e.g., associated with by a medical caregiver and digitally signed) and one or more for parameters.
  • a similar paired use of stickers may be used by a user (e.g., required by the implant), for example, for set up or for particular implant activations and/or for all implant activations.
  • a plurality of authorization levels may exist, for example, some device settings being authorizeable by a nurse and some by a doctor and some by a specialist.
  • Fig. 14 also shows an authentication and/or authorization server 1422, provided in some embodiments of the invention.
  • this server is used by charger 1404 (or indirectly by implant 1402) to verify the authenticity of an attempt to provide instructions and/or units to the accounts. For example, when a payment element 1408 is used to charge account 1406, charger 1404 may check with authentication server 1422 if the value provided by payment element 1408 is still valid.
  • Fig. 14 shows an optional billing server 1420, in accordance with some embodiments of the invention.
  • billing server 1420 is used by a care provider such as a HMO, to help regulate treatment to a patient.
  • Billing server maybe used to dispense usage authorizations. In this sense billing server 1420 may act like a pharmacy.
  • billing server 1420 can dispense limited life "treatment", which can prevent overusage or delayed usage of treatment by a patient. Similarly, underusage may be reported to billing server 1420.
  • a separate treatment server 1424 is used to track treatment and determine treatment dispensing logic.
  • the various servers can be combined as a single server or the tasks carried out by them otherwise divided up, in some embodiments of the invention.
  • one or more of the above described servers is configured (e.g., using an expert system or a rule based system or a table of options) to generate a set of stickers suitable for situation comprising a patient, an implant, a disease state, a quality of care, a budget and/or a desired result.
  • a set of stickers suitable for situation comprising a patient, an implant, a disease state, a quality of care, a budget and/or a desired result.
  • such generation is in response to a request by a doctor.
  • the server issues instructions to program or assemble authorization codes and/or stickers or other control components, optionally marked for and/or pre-coded for a particular patient, implant and/or medical health provider.
  • a potential advantage of using accounts to control authorization is that direct communication with implant 1402 is not needed, while control over its usage can be obtained.
  • a payment element needs to be loaded with input from implant 1402 if it is to be recharged.
  • loading is automatic by charger 1404.
  • a payment element 1408 e.g., in a sticker
  • control of the implant is by controlling the charger 1404.
  • charger 1404 is limited (or blocked) in its ability to charge implant 1402 absent sufficient credit in one or more accounts 1406 thereof.
  • the amount of charge which can be passed may be limited by such credit, requiring more frequent charging or disabling certain implant functions based on lack of sufficient charge.
  • limits may be place on other functionality of charger 1404, such as ability to read data or ability to send programming.
  • Fig. 15 is a flowchart 1500 of a method of using system 1400, in accordance with some exemplary embodiments of the invention.
  • implant 1402 is used.
  • account 1406 (or an account in implant 1402) is optionally updated based on the usage.
  • the account is low enough (or zero) that one or more functionalities is optionally blocked and/or reduced in amount and/or quality.
  • the device moves to a low-functioning state where various machine functions are changed. For example, when a functionality is blocked, logic of applying other functionalities may be changed.
  • implant 1402 optionally continues to operate in a low-functionality state, optionally one which maintains all life-saving therapies of implant 1402 and/or which prevents disease progression.
  • one or more accounts in implant 1402 or a controller thereof are optionally updated (e.g., increased), for example, using a payment element 1408 or a direct connection to a server.
  • Implant 1402 or charger 1404 may authenticate the update using a remote server, for example, if the update is in the form of digitally signed tokens or in the form of one time codes.
  • the device operation mode optionally changes, for example, to a high-functioning state.
  • implant 1402 is a CRT device, which is optionally programmed in an off mode. Applying a sticker (optionally batter powered) to the skin near implant 1402 or an antenna thereof causes implant 1402 to go to an on-mode. If an account mechanism is used, implant 1402 may be in a high-functioning on state. Once the account is empty, the device may return to a low-functioning state, rather than an off-state. Optionally, to go to an off-state, the sticker may need to be removed, or an "off-control" sticker applied. This may prevent inadvertent turning off of implant 1402.
  • sticker-based mode changes may be useful for other reasons.
  • a device mode may be changed based on health consideration, with different stickers providing different operation logic and/or parameters.
  • a device which is malfunctioning or having undesired effects may be switched off or its functionality changed, using an appropriate sticker.
  • a device which causes nausea may be temporarily turned off for a meal using a sticker.
  • a pain control device is switched off during exercise or sleeping (or taking of medication), where pain may be less sensed, to avoid side effects.
  • sticker-based functionality control may be provided also with self-powered (not rechargeable) implants and/or with implants using other, possibly standard, recharging techniques.
  • the logic of selecting which functionality is active and/or the details of operation of the implant are provided in the implant, with the sticker or other external control only providing authorization and/or accounting services.
  • a sticker or controller may determine device parameters and/or if or when to apply a therapy and/or analyze sensed signals to decide on therapy.
  • a sticker is used for temporary pain control (e.g., 15 minutes, an hour, 6 hours or intermediate time periods).
  • the device is activated for 5-10 minutes (or some other sub-60 minute period and stays off absent user indication (e.g., via a sticker) that more relief is needed.
  • attaching a long pain relief sticker may cause additional pain relief stimulation of, for example, 30 minutes, 4 hours or more.
  • implanted stimulation systems need not be for stimulation.
  • an implanted system may be used for monitoring (e.g., blood pressure or glucose level monitoring).
  • an implant may act as a valve or as a pump (e.g., LVAD).
  • stimulation can be by release of a drug, possibly systemic release.
  • non-electrical stimulation may be provided, for example, stimulation using light, magnetic fields, electromagnetic fields and ultrasound.
  • LVAD left ventricular assist device
  • the sticker includes an insulin sensor (e.g., transcutaneous or using a transcutaneous sensing element on the sticker), so that the pump provides insulin as a function of blood glucose.
  • c. Neuromodulation device for pain stickers are used by a patient to control pain and/or load up an account in the device to allow it to operate.
  • the degree of pain relief/stimulation and/or parameters thereof are set by the sticker.
  • a patent applies a sticker as needed to control symptoms.
  • Cochlear implant In an exemplary embodiment of the invention, the sticker provides sensing of environmental sounds, using a sensor on the sticker.
  • different stickers may be provided for different settings, such as quiet, office and party.
  • each such sticker directs the implant to apply different signal processing algorithms and/or parameters thereof.
  • a sticker is used to release a drug dose and/or to set a desired release schedule.
  • the device is activated to apply CRT therapy as needed to control HF (Heart Failure), responsive to decompensation (e.g. fluid accumulation) detected by a sensor on the sticker (e.g., an impedance sensor).
  • CRT therapy for example, when HF symptoms are not detected, requires extra payment/authorization.
  • additional therapy for example, responsive to detected heavy breathing, requires extra payment/authorization.
  • the signal is applied in response to an eating event.
  • eating detection is by the sticker for example using abdominal electrical sensing or impedance measurement or by sensing swallowing motions using an accelerometer or tensile sensor on a suitably placed sticker or by user input via the sticker, by the act of attaching a sticker or by a user swallowing a pill- shaped control component before, during or after eating.
  • signals are applied periodically to control hunger.
  • a sticker may set how quickly the device will stimulate the stomach after sensing food consumption - a shorter amount of time may cause the person to eat less at each intake due to an earlier sensation of satiety.
  • a different sticker may also control the food consumption detection threshold -> lower threshold means fewer false negatives but more false positives.
  • the user experiments with stickers at home (optionally provided as a kit) to detect a desirable threshold setting.
  • Such a set of "calibration stickers” may be provided for other devices and parameter sets.
  • the implantable device remembers the last used sticker set-derived parameters until reprogrammed (e.g., using different stickers),
  • PA Implantable Pulmonary Artery
  • a sticker could control the accuracy and frequency at which the signals are recorded.
  • a patient uses a sticker to "signal" his activity during the day as this could affect the observed changes in the pressures recorded.
  • this will allow a health care professional who reviews the logs to detect abnormalities more accurately than without such stickers indicating the type of activity. For example, if the patient is resting he should use the sleeping sticker. The choice of sticker is then recorded on the implantable device during the recording session. Then the data is transmitted for review and the reviewer may notice some fluctuations in PA pressure which are out of the ordinary for a patient who is resting.
  • control components and peripheral components can provide various functionalities in a range of use scenarios.
  • stickers or other control components
  • for implants and/or for non-implanted medical devices can provide various functionalities in a range of use scenarios.
  • stickers may be provided in the form of "on'V'off ' or only “on” or “off and applied to change the state of the implant.
  • the settings of the device are not affected.
  • one or more mode stickers are provided for example a sticker which instructs the implant to "change to mode A".
  • a sticker adjustments of one or more implant parameters to a level defined in an absolute manner by the sticker or a relative way depending on the configuration on the device (i.e. + or - 5% of threshold X) and optionally activates that mode.
  • a first set of stickers may relate to amplitude and a second state of stickers to delay and a third set of stickers to heart rate pacing threshold.
  • a mix of stickers may be used to effect a desired behavior of the pacemaker.
  • a GP who doesn't know or have a programmer can sell, provide or prescribe the stickers to a patient and/or use them to change device settings.
  • a variety of stickers is provided, optionally color, shape and/or textually coded, for various complex settings.
  • different stickers will have different effects on therapy.
  • a pacemaker which is also an ICD and provided cardiac contractility modulation (CCM) treatment
  • CCM cardiac contractility modulation
  • a pink sticker increases CCM delivery by 10% and a green sticker sets an ICD to safe mode before an operation.
  • the intensity or other parameter is coded using an analog coding such as color intensity, for example, light blue is +5% and dark blue is +25%.
  • the coding is via pictures, optionally schematic.
  • this allows non-literate users to operate and even program an implant as needed.
  • the coding indicates a symptom to be overcome by the sticker.
  • a patient may be given two or more sets of stickers and the patient would use the different stickers at different times / activities. For example, a "high cardiac output” mode being activated before going for a long walk, using suitable sticker and a “rest mode” being activated before sleep by a different sticker.
  • single or double blind stickers may be used, whose effect is unknown to the user and known to the treating doctor or unknown to both the patient and the directly treating doctor (the usage code is optionally logged by the implant and/or charger/controller).
  • a sticker can also be a placebo sticker which actually keeps the device off and provided to a sham treatment group.
  • the usage of the stickers is sophisticated and/or versatile enough to provide programming and optionally replace the need for a separate programmer.
  • smarter stickers are used, for example, a sticker with a display (e.g., showing vital signs, key therapy indicators, and/or remaining credit level).
  • the sticker includes a communication circuit to communicate with, for example, a cellular telephone which is optionally used to program the sticker, for example, for one or more of "top up credit", change sticker parameters (optional with a change n visual aspect of the sticker, for example, by control of a display thereof), for example in response to an electronic prescription from the doctor and/or provide a remote follow up mode.
  • a set of stickers is provided in a package suitable for, for example, 20 days, 30 days, 40 days or a smaller or intermediate or larger number of days.
  • stickers are provided as a sample set, for example, to help determine what treatment is good for the patient and/or for marketing purposes.
  • a sample set can be given to doctors for free in the form of stickers for devices.
  • “try the new algorithm for pain relief - the algorithm / settings are kept on the sticker and given for free for one month.
  • the implant supports additive effects, namely that the output of the implant is a combination of the output mandated by each sticker. This can be used in drug delivery systems or where device has multiple functionalities and/or where a single functionality has multiple settable parameters.
  • the drug delivery system may have 5 different drugs and endless number of combination of the drugs it can administer.
  • Each sticker can contain the exact amount of drugs to be delivered with the dose and time.
  • the dosage is a daily dosage.
  • example dose may be defined as "hours per day”.
  • the dosage is per event, for example, a pacemaker "power sticker" may be used when an energy- intensive activity is carried out (increase cardiac output acutely), for example, for a period of 15 minutes.
  • the device includes a safety feature (optionally overridable by another sticker) which limits application of sequential "power stickers" to provide a high cardiac output period which is too long for safety.
  • stickers are coordinated with other treatment, like surgery, physical therapy or medication.
  • a sticker is marked with a timing indicator, such as "two hours before therapy” or "two days after surgery”.
  • stickers are associated (and provide different implant activity) with various daily activities, for example: sleep, eat, office work, drive, exercise, sexual activity.
  • a LVAD decreases pumping capacity on low exercise (when an appropriate sticker is applied).
  • the use of such stickers allows a simpler implant to be used, as the user himself can act as a sensor to determine what mode needs to be activated and/or what relief provided.
  • a set of suitable stickers is sold (or otherwise provided) as a kit, for example, with the implant or on its own, it is provided with instructions for use in such programming and/or other usage as described herein.
  • kits of stickers are provided with a patient code or implant code to assist a programming caregiver in matching up the set with the patient.
  • different stickers are provided for different patient weights.
  • different stickers are provided for different patient symptoms (e.g., pain, breathlessness, headache) and/or for different implant side effects. For example, if using an LVAD at certain parameter settings causes dizziness, a pink sticker may be applied, which will then ensure that blood pressure is increased (possibly not to an amount which provides unacceptable risk). Blood pressure is optionally measured by the LVAD itself, with the sticker optionally indicating desired threshold or increase in threshold
  • stickers are used for different environmental conditions.
  • different stickers are provided for different air pollution levels (high smog, clean air etc), for example, a CPAP device may use different filtering based on the sticker indication, potentially extending a life of components thereof.
  • an accelerometer is often used by a pacemaker to estimate user activity.
  • misreading caused by transportation e.g., cars, trains
  • transportation e.g., cars, trains
  • control or payment element is provided inside the body rather than on its surface.
  • such an element naturally passes through the body (e.g., the GI tract) and in some embodiments, may be placed and then removed (e.g., other orifices).
  • Fig. 16A is a schematic showing of system 1600 including a swallowable activator 1604 for an implanted medical device 1602, in accordance with some exemplary embodiments of the invention.
  • activator 1604 is pill- sized and/or shaped, for example, being spheroid, ovoid and/or cylindrical.
  • a maximum dimension of activator 1604 is between 0.2 and 4 cm, for example, between 0.3 and 2 cm.
  • the maximum dimension is at least 1.5 times the next sized dimension, in extent.
  • an implant 1602 for example, a cardiac stimulator or a gastric stimulator is implanted and optionally includes an antenna or reader 1606, for example, wirelessly or wired connected to implant 1602 to read activator 1604.
  • Wireless readers may be useful if the antenna location is remote from the implant and to avoid excess wires in the body.
  • an antenna 1606 can read activator 1604 as it passes through the esophagus.
  • a same or different antenna can read activator 1604 as it sits in a stomach.
  • a same or different antenna can read activator 1604 as it passes through the intestines.
  • activator 1604 is shown to be for the GI tracts, it may be otherwise provided internally, for example, into a vaginal tract, rectally inserted, nasally inserted, inserted into a urethra (e.g., to a bladder) or inserted via a wound or other body opening or implanted tube. In some of these locations, activator 1604 will need to be removed manually.
  • activator 1604 is activated manually before insertion and/or activated by insertion itself (e.g., moisture and/or pH).
  • activator which is a senor which is a senor.
  • activator which is a senor As noted above, two types of activators may be used, an activator which is a senor.
  • An esophageal reader may be suitable for one time reading, stomach reader suitable for short term activity and intestinal reader suitable for longer activity.
  • Fig. 16B is a block diagram of a pill-using implant system 1650, in accordance with some embodiments of the invention.
  • an activator 1604 includes a transmitter (or transceiver) 1652 for communicating with reader 1606 of implant 1602, a control 1654 (e.g., for controlling activator 1604 and/or storing data thereon) and an optional activator circuit or mechanism 1656.
  • activator 1656 comprises a power source, such as a battery, which is activated or connected by body fluids. Alternatively or additionally, a seal on activator 1656 is removed before use.
  • the activator 1656 is selected to be activated by a particular body fluid (e.g., stomach fluids, GI tract fluids), so as to be activated at a desired time/location in the body.
  • a particular body fluid e.g., stomach fluids, GI tract fluids
  • an activator as known in the art of delayed activated Gl-capsules is used.
  • a programmer 1658 with a socket 1660 for activator 1604, is provided.
  • programmer 1658 is used to load control 1654 with desired control instructions.
  • activator 164 is in the form of a pill and provided as such to a user and a user cannot program it.
  • activator 1604 is formed of bio- compatible and/or digestible materials, so as not to cause adverse reactions.
  • any incompatible materials are coated to prevent interaction thereof with the body.
  • transceiver 1652 is an active transmitter which transmits after the activator is swallowed.
  • transceiver 1652 is a transponder which responds to interrogation by reader 1606.
  • transceiver 1652 is powered.
  • transceiver 1652 is a backscatter transponder which is powered by reader 1606.
  • Fig. 17 is a schematic showing of spatial control in accordance with some embodiments of the invention.
  • control of the implant parameters includes control of which part of the body is affected by the implant. While this may be coded using different stickers (e.g., different colors), in an exemplary embodiment of the invention, the encoding is spatial, in that a sticker applied to one location will have a different effect than a sticker applied to a different location.
  • such spatial encoding is used for things other than spatial control of the implant.
  • Fig. 17 shows a system 1700 including an implant 1702 with multiple antenna 1704, 1706, 1708.
  • placing a sticker e.g., 1710, 1712, 1714
  • the antenna are all located in a small region, to assist with implantation.
  • the antenna may be placed far apart, for example, near the tissue to be affected.
  • a single neuromodulator device may have multiple leads coming near the skin at different locations: the neck the back and the right leg - these are the three places the patient complained she has pain.
  • a sticker can then be placed on the region of the pain in a very intuitive manner to relieve the pain around the sticker area or in an associated organ. This may also improve the "placebo" effect.
  • multiple stickers can be used at the same time to control the degree of pain relief in different parts of the body.
  • different pain relief mechanism may be used in different areas, for example, nerve blocking in one and overstimulation of peripheral nerves in another and drug release in a third.
  • a same sticker can cause very different implant operation based on positioning thereof.
  • such a user may have multiple implants implanted therein, for example, to provide the desired coverage.
  • the treatment locations are mapped to a small region, for example, a part of the abdomen.
  • a drawing at the sensitive location may assist in mapping location to treatment effect.
  • a drawing of the body may be provided in miniature on the abdomen and a body region affected by placing the sticker at a corresponding part of the drawing.
  • the drawing is made using a temporary tattoo material after antenna implantation.
  • the antennas are provided as a sheet including plurality of antenna and possibly a single lead, rather than as multiple leads as shown in the figure. This may simplify implantation.
  • the sticker may be provided in different shapes (e.g., including different active portions) to achieve a different desired effect.
  • a sticker matching a body shape may be reshaped by a user (e.g., a leg removed) to indicate that therapy to the leg is not needed.
  • Each portion of the sticker may include a different coded section, so that when whole, multiple coded sections are read by the implant and when reshaped, fewer coded sections are read (and thus possible fewer body portions are treated).
  • the sticker may have a shape which indicates its spatial and/or other function. For example, a leg shaped sticker will activate therapy for a leg (e.g., being suitably encoded for this).
  • a related issue is ensuring that a sticker is placed near a desired antenna.
  • a magnetic proximity mechanism is used in which a magnet and a ferromagnetic material or another magnet attract each other or repel each other in a manner which a user can sense as he moves the sticker with one material, about an areas with the matching material implanted near a "sticking" zone.
  • the sticker includes a light or vibrator which reacts to the proximity of an antenna by sending out a human- sensible signal.
  • the sticker location is marked with a tattoo and/or with a tactile indicator whereby the antenna modifies the feel of the skin at the location.
  • Fig. 18 is a schematic showing of a system 1800 with a peripheral 1806 for an implant 1802 or other (e.g., non-implanted) medical device, in accordance with some exemplary embodiments of the invention.
  • sticker 1806 includes a communication module 1808, for example for sending data to and/or receiving data from implant 1802, via an antenna 1804 thereof.
  • sticker 1806 includes one or more sensor 1810.
  • the sensor senses a physiological parameter or a proxy therefor, such as one or more of heart rate, acceleration, skin pH, skin temperature, local oxygenation, local pulse and/or skin conductivity.
  • the sensor senses an environmental value, such as temperature or noise, air pollution (e.g., particles or materials), water pollution (e.g., materials, transparency or conductivity), air pressure, UV radiation or EM radiation.
  • the sensor senses a user input, such as a finger press or finger location on or near sensor 1810.
  • the user input is used to send a command to the implant, for example, "now eating”.
  • sensor signal analysis is in implant.
  • at least pre-processing is in sticker.
  • such input is used to protect the implant.
  • sensed EM radiation may be used to detect a high noise environment and change the device mode to a "safe" mode.
  • sensor 1810 is used to measure an external stimulus, for example one or more of acceleration, sound, light, heat, radiation, mechanical pressure.
  • an accelerometer may be used to identify activity of patient and to switch to appropriate pacing program.
  • a sound sensor is used to detect voice commands from the patient.
  • a plurality of sensors is used.
  • a sound and a touch sensor may be combined to allow voice control (e.g., touch sticker and say "pain relief lower back").
  • light sensing is used to detect whether it is day or night in order to adjust activity of CPAP device.
  • atmosphere sensing e.g. particular matter
  • filtering level may be used to determine other CPAP settings, for example, filtering level.
  • mechanical pressure is used to sense a user input, for example, a patient can swipe the sticker with finger to hear a current heart rate and device recommendation for sticker application.
  • audio output is provided by the sticker (e.g., via an output 1812) or via the implant.
  • an output 1812 is provided, for example, a piezoelectric speaker and/or one or more lights.
  • a sticker used with a gastric stimulator can indicate to a user when to stop eating by making a certain sound. The sound can be generated by a circuit printed on the sticker and a piezoelectric crystal. Power can come, for example, from the implant or from a battery on the sticker.
  • the sticker has a coating which can change color, for example, as a function of voltage applied thereto by output 1812.
  • UI user interface
  • sticker 1806 includes a communication module 1814.
  • communication comprises retransmitting power from a power source, collected by sticker 1806 and sent on to implant 1802.
  • communication comprises adding a reading functionality to implant 1802, for example, the ability to read a smart card or RFID.
  • communication comprises a two way link or a command link to another device, for example, a therapy device or a communication device (e.g., a cellular telephone or a computer).
  • sticker 1806 act as a gateway translating between the communication protocols of implant 1802 and a different device, such as a cellular telephone or a programmer.
  • different stickers are provided for different pairs of implants and external device.
  • sticker 1806 includes a therapy functionality by, for example, including a drug release source 1816.
  • sticker 1806 provides local electrical therapy and includes one or more electrodes thereon.
  • sticker 1806 is optionally powered by energy provided by implant 1802.
  • Fig. 19 is a schematic showing of system 1900 including a non-implantable medical device 1904 using a separate controller component 1908 in accordance with some embodiments of the invention.
  • Accounts 1906 and 1910 and billing server 1920 and authentication server 1922 may function, for example as described above with reference to corresponding components in Fig. 14.
  • an electrode or other actuator or sensor 1914 is in contact with the body, while device 1904 lies outside the body.
  • one or more designated locations are provided on device 1904 for controller component(s) 1908.
  • a pocket 1912 is provided, optionally with an openable lid.
  • a magnetic attachment is used instead of or in addition to adhesive attachment.
  • pocket 1912 has a shape which matches the shape of component 1908 and a desired orientation thereof.
  • device 1904 has one or more internal antenna (not shown) adjacent pocket 1912 or other designated and/or shaped location for component 1908.
  • component 1908 includes one or more electrical contact which match a contact on device 1904, for example, for receiving power therefrom and/or sending data thereto.
  • non-implantable devices controlled using components 1908, for example, as described herein.
  • a. TENS. Application may be PRN, with a sticker corresponding to a treatment.
  • CPAP CPAP.
  • Application may be nightly, with a sticker setting time, measuring snoring, SP02 and/or detecting apnea and optionally sending results of such detection to the CPAP device.
  • a sticker may be used to set an activity time, for example, per day or per distance traveled or per number of movements.
  • TTF Tumor Treating Fields wearable device, such as provided by Novocure
  • these are used for cancer treatment, using one or more stickers to control the application TTF to treat cancer.
  • TTF devices are worn chronically by cancer patients and it may be desirable to provide multiple therapy programs (e.g., with different settings for one or more of field strength, time and/or other parameters). Different programs may be associated with different side effects.
  • one type of sticker may be more effective when sleeping and another one more effective when awake.
  • Stickers may also be designed to optimize parallel use with chemotherapy.
  • a sticker may be used to activate the TTF device together with chemotherapy and/or provide a preprogrammed delay and/or provide different parameters based on the chemotherapy (or other therapy), for example, as indicated by sticker coding.
  • Fig. 20 is a schematic showing of a system 2000 having a sticker 2008 whose use is limited using one or more mechanisms, in accordance with some exemplary embodiments of the invention.
  • sticker 2008 includes a fuse 2012 which decays after a time.
  • the fuse may decay chemically in contact with the atmosphere (e.g., oxygen) or other environmental conditions, such as skin moisture and/or temperature.
  • the fuse may be damaged by passage of electrical current therethrough.
  • the fuse is a critical current carrying component of sticker 2008, for example, forming part of a data readout circuitry or a transmission circuitry 2010 thereof.
  • fuse 2012 is provided as a battery which discharges over time, for example, being a zinc-air battery which oxidizes over a known time period.
  • sticker 2008 stores data thereon in an encrypted manner 2014. This may prevent readout and/or modification of data thereon.
  • sticker 2008 includes a token creation circuit 2016 which generates one time codes in a sequence. This may prevent duplication of sticker 2008.
  • the data on sticker 2008 is a token and implant 2002 authenticates the token using an authentication circuit 2006 before use thereof.
  • circuit 2006 is a separate circuit which optionally acts as a "watchdog" on standard implant circuitry.
  • circuitry 2006 is integrated into the rest of the implant circuitry.
  • authentication is via an authentication server 2020 with which implant 2002 optionally communicates directly or indirectly (via sticker 2008, using encrypted or signed communications).
  • implant 2002 stores used tokens thereon to prevent accidental or intentional misuse.
  • sticker 2008 (and/or implant 2002) include a clock 2018 and the pay load of implant 2002 is limited to operate in response to sticker 2008 only during a certain time window (or time of day or other time based limitation).
  • at least one part of sticker 2008 is made inoperative when outside such time window.
  • control circuitry may prevent data transmission outside the time window.
  • a sticker is certified for a particular implant or user (e.g., a user has a smart card which can be read by the sticker to activate it).
  • the sticker is programmable and the programming includes codes which provide this or other functions.
  • implant 2002 and/or other components such as a programmer, track usage of codes with implant 2002 and report such usage, for example, periodically. Detect of suspension usage may block enhanced and/or other functionality of implant 2002, for example, using logic on implant 2002 and/or in a programmer (not shown).
  • a sticker acts as a rechargeable container, however, it can only be recharged if it is authorized for such recharge by server 2020.
  • server 2020 may require to read usage data stored thereon by implant 2002, before authorizing recharge.
  • the recharging includes an indication of previous codes on the sticker, so that a particular recharge can only work with a particular sticker, as an implant (or programmer device) can request to read both the current and previous codes and they need to match.
  • FIG. 21 is a flowchart of a method of device mediated cost control, in accordance with some embodiments of the invention.
  • a diagnosis of the patient is provided (for example, heart failure).
  • the prediction includes a prediction of needed therapy.
  • the prediction includes a statistic related to need to activate a therapy providing device (e.g., expected number and or severity of events).
  • the prediction is provided by the implant and/or its programmer, or by a remote server.
  • a budget for treatment is provided.
  • the budget is provided in view of the diagnosis and/or the prediction.
  • the budget is a health budget which takes into account an amount of therapy which it is expected that the patient can handle.
  • an allocation of budget resources is determined.
  • the allocation can include baseline treatment amount, threshold for applying baseline treatment and a number and/or degree of event-related treatments for acute events.
  • the allocation may define a threshold of disease state above which treatment is provided and/or an amount of treatment to provide for different events.
  • this allocation is used to calculate an issue a plurality of stickers and/or usage codes for the patient, for example, on a monthly basis.
  • a first therapy is applied, for example a baseline CRT therapy.
  • this therapy is applied independent of budget, for example, being included in a basic treatment package.
  • a request is made to apply a second therapy, for example, CCM, for example in response to an increased need in cardiac output, for example exercise.
  • the request may be made by the implant (e.g., sensing cardiac output) or by the user (e.g., apply a sticker).
  • the determination takes into account health consideration (e.g., a safety rule may prohibit two CCM applications at times that are too close or durations that are too long.
  • the determination takes into account available usage codes and does not apply the therapy if such codes are not available or a usage account is empty or near empty.
  • the determination takes into account a budget for future needs, to ensure treatment options remain open as predicted. For example, the allocation may include treatment for five events a month, while ten are expected. This means that during the first half of the month no more than five events will be treated and/or that events with a lower severity will not be treated.
  • feedback is provided, for example, to the user, indicating if/how therapy is applied.
  • the process is repeated.
  • the patient is periodically re- diagnosed and/or if patient is issued additional resources, the allocation and budget may change.
  • this method may also be applied where there is no budgetary limit and be based on health considerations only.
  • the management of the budget and allocation are performed using an app which is executed in a cellular telephone, portable computer or other computer.
  • an app interacts with a user, displaying various treatment options and considerations for approval.
  • the app includes a rule-based expert system and/or a different "optimizer" software which takes into account, for example, the amount of available income, income stability, diagnoses, and desired treatment and finds an optimal or near optimal therapy plan.
  • budgeting and/or allocation and/or advice from the implant are provided by the implant, optionally via a sticker-based user interface, for example, as described herein.
  • the charge for applied treatment depends on one or more of its type, amount and degree.
  • the budget allocation takes into account treatment income variations, for example, based on day, month or season. For example, more treatment (e.g., CRT) may be allocated for a harvest season when there is less income uncertainty and less treatment (e.g., only ICD) in the winter, when the harvest and income therefrom are unknown.
  • more treatment e.g., CRT
  • less treatment e.g., only ICD
  • the charge for treatment is inversely related to need. For example, if the implant senses a greater need (e.g., a greater need for cardiac output), then the price for treatment goes down.
  • a sticker is used for overriding.
  • an implant may be programmed to treated only above a certain threshold and a sticker (e.g., of a limited supply) by applied to override this threshold and treat.
  • a sticker is used to prevent therapy from being applied, for example for budget or health reasons. Compliance
  • Some embodiments of the invention provide features which may improve compliance, especially in pay-per use settings and/or where stickers are used to activate a device.
  • One or more of the following features is optionally provided in some embodiments of the invention. It is noted that one or more of these features can be implanted without a sticker or usage code mechanism, for example, by allowing communication between an implant and a server, programmer and/or patient. However, use of stickers and/or pay per use may enhance the usefulness of one or more of these features.
  • a first feature of some embodiments of the invention is that positive control by user may be applied. This may help keep the patient aware of ongoing therapy and increase compliance of other treatments. Optionally or alternatively, the fact that a user can control expenditures may allow a user to better match his needs to his budget, rather than avoid treatment out of fear of running out of money.
  • a second feature of some embodiments is that a physician can apply treatment (e.g., a sticker), without the patient needing to take an active part (other than not remove the sticker). Such application may last until a next visit.
  • treatment e.g., a sticker
  • a third feature of some embodiments is that the sticker may be visible, providing a visible reminder to the patient to replace the sticker and/or that therapy has been applied. This may be useful n patients with memory problems.
  • color change by the sticker is used as a reminder to replace the sticker.
  • a fourth feature of some embodiments is that a physician can "program" the device using a sticker, potentially alleviating the need to use a programmer and making it more likely that the implant will be properly used.
  • a fifth feature of some embodiments of the invention is that an implant or other medical device can be programmed with an expected usage pattern and detect hen such pattern is not met.
  • the patient can be offered various incentives, starting from psychological incentives and also financial incentives (e.g., reduced cost stickers, increase treatment duration for same price), which may relate to the treatment or be independent thereof (e.g., shopping coupons, reduction in health insurance rates).
  • financial incentives e.g., reduced cost stickers, increase treatment duration for same price
  • usage is reported to a billing server or health server is noted above.
  • incentives are calculated by the implant and/or by a remote server.
  • a "coupon" sticker is provided, which a patient can apply to the device to receive special offers.
  • a patient may be offered alternative treatment, for example, if side effects are causing lack of compliance.
  • the use of stickers makes it easier to instruct a user how to change his treatment (e.g., "use pink stickers instead of green stickers in the morning").
  • a sixth feature of some embodiments of the invention is tracking an effect of treatment and/or side effects, for example, using one or more sensors on the sticker and/or one or more sensor in the implant.
  • such sensing may be used to detect not only usage but also side effects and/or efficacy.
  • detection may be reported to a treatment (or other) server for suggestion of alternative therapy.
  • determination is carried out locally, for example, by the implant and/or programmer.
  • suggestion is by a physician calling up a patient and suggesting sticker change and/or downloading usage codes to the user (e.g., via cellphone), optionally for loading into a sticker or the implant.
  • determinant of danger of disease progression is used to warn patient of the importance of compliance.
  • the patient is told both the effect of his non-compliance and the effect of his partial compliance.
  • the implant (or other parts of the system) can track the effect of such communication, by assessing which input the patient responds to (by applying sticker) and which not.
  • a seventh feature of some embodiments of the invention relates to patient feedback.
  • the sticker therapy and/or formulation is selected so as to enhance a user's perception of efficacy.
  • the dosage of therapy applied by a sticker is selected so that a patient will notice is effect and/or notice the effect of the sticker being stopped.
  • some therapies such as electrical stimulation can have relatively fast effects and/or relatively fast decay of effect.
  • sticker based therapy includes a gradual rise or decay, for example, to avoid abrupt shocks to the body.
  • sticker-initiated therapy may have a defined ramp-up and/or a defined ramp-down period.
  • each such period is, for example, between 1% and 30% of the treatment time, for example, between 5% and 20% or between 2% and 10%.
  • the periods are ignored if stickers are applied consecutively.
  • the sticker includes an indication of efficacy, for example, heart rate or acceleration, or such indication is sent to a patient's cellular telephone or computer, thereby allowing user to see that applying therapy has a measurable effect.
  • the sticker includes the sensor needed to calculate this efficacy (e.g., accelerometer and/or GPS to show distance walked or height climbed before rest), or the sticker receives such indication from the implant.
  • the sticker operates without input from the implant, for example using only own sensors.
  • An eighth feature of some embodiments of the invention relates to pay-per-result, rather than pay-per-use.
  • a user can pay based on an effect of treatment or be provided a refund (full or partial) based on effect. For example, in a HF treatment system, if cardiac output is not increased, then a patient may not pay.
  • the above described accounts are not debited or debited less according to a degree of effect detected by the implant, programmer and/or sticker (e.g., depending where sensing is located).
  • the implant reports an efficacy of treatment (or a treatment episode mandated by the sticker), for example, by indication of an effect of treatment or a physiological measurement, to the sticker and this data is optionally uploaded back to a billing server to calculate a charge or refund, for example, based on a promised effect.
  • the sticker consumes authorizations or refunds thereof based on said uploaded efficacy.
  • what is reported is actual operation of the implant, for example, not charging or charging less authorizations when the implant did not provide an active therapy. This may be useful for implants with a consumable, such as a drug eluting implant.
  • Such pay per result may encourage patients to use treatment and/or allow implantation as their financial risk is lower.
  • a proxy indicator is used.
  • a pain treatment device may use heart rate or blood pressure as indicators of stress caused by pain and relived by device.
  • a user may be allowed to report efficacy.
  • f user reports no efficacy, treatment is blocked. This may prevent or reduce fraudulent reporting.
  • performance is evaluated by a third party, for example, laboratory blood tests or a stress test.
  • a third party for example, laboratory blood tests or a stress test.
  • Such data may be entered into the implant and/or sent to a billing server for determination of payment/refund.
  • efficacy is used to control payments between a health care provider and the device provider. For example, more payment if there is more effective treatment and/or lesser side effects.
  • a ninth feature of some embodiments of the invention is that payments per use are small, so that a financial risk of a user are reduced, especially if a user can refund unused usage codes (e.g., by allowing such codes to be erased form a sticker connected to the internet).
  • an intrabody medical system as described herein includes, in addition to a medical payload and control circuitry programmed to activate the medical payload, receiver circuitry and account memory storing therein at least one value indicating one or more authorizations to activate.
  • the account memory is operatively connected to the receiver circuitry to receive such values.
  • the control circuitry is configured to activate the medical payload responsive to one or more authorizations from the account memory and thereafter consume at least one authorization, optionally taking into account efficacy thereof.
  • a desired efficacy is provided by a sticker, for example, as described herein above, for example, programmed by a doctor, pharmacists and/or remote server.
  • 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.
  • 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 term "method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
  • the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

Abstract

La présente invention concerne un système médical à plusieurs parties possédant les éléments suivants : (i) une partie intracorporelle comportant une charge médicale utile, un circuit de commande commandant ladite charge utile, et un récepteur sans fil relié par une connexion de donnés audit circuit de commande; et (ii) un composant séparé suffisamment petit pour (a) pouvoir être accouplé mécaniquement de manière temporaire à un corps humain sans en affecter l'ambulation, ou b) pesant moins de 75 grammes, comprenant un émetteur sans fil pouvant être couplé sans fil audit récepteur sans fil et conçu pour transmettre un ou plusieurs éléments parmi des données, de l'énergie et des instructions à ladite partie intracorporelle.
PCT/IB2014/067096 2013-12-18 2014-12-18 Dispositif médical avec régulation séparée WO2015092747A2 (fr)

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