WO2014031800A1 - Therapeutic energy systems - Google Patents

Therapeutic energy systems Download PDF

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Publication number
WO2014031800A1
WO2014031800A1 PCT/US2013/056072 US2013056072W WO2014031800A1 WO 2014031800 A1 WO2014031800 A1 WO 2014031800A1 US 2013056072 W US2013056072 W US 2013056072W WO 2014031800 A1 WO2014031800 A1 WO 2014031800A1
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WO
WIPO (PCT)
Prior art keywords
device
energy
system
therapeutic
optionally
Prior art date
Application number
PCT/US2013/056072
Other languages
French (fr)
Inventor
Carl Mayer
John Ellenz
Original Assignee
Energize Medical Llc
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
Priority to US201261692228P priority Critical
Priority to US61/692,228 priority
Application filed by Energize Medical Llc filed Critical Energize Medical Llc
Publication of WO2014031800A1 publication Critical patent/WO2014031800A1/en
Priority claimed from US14/494,603 external-priority patent/US20150105701A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00172Connectors and adapters therefor
    • A61B2018/00178Electrical connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00702Power or energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/0072Current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00767Voltage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00779Power or energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00839Bioelectrical parameters, e.g. ECG, EEG
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00863Fluid flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00988Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension

Abstract

The invention provides a therapeutic system comprising: a console, wherein the console comprises a controller and an energy generator; a therapeutic device comprising: an operational head configured for transmitting the energy output from to a biological tissue; and a memory device comprising control instructions, wherein said control instructions comprise instructions for controlling the console; a reversible memory operable linkage linking the memory device to the controller; and a reversible connector configured for operably linking the energy generator to the operational head. Optionally, the energy generator is a generator of ablation energy or heat energy (e.g. RF generator) and the control instructions comprise instructions for controlling the output of the energy generator. Optionally, the control instructions comprise one or more parameters of energy output or an algorithm configured for controlling the energy output. Optionally, the system further comprises one or more secondary therapeutic devices and the control instructions comprise instructions for controlling the one or more secondary therapeutic devices. Optionally, the system further comprises one or more sensors configured for sensing parameters of energy output or biological or environmental effects of the energy output and the control instructions comprise instructions for controlling the energy output and/or secondary therapeutic devices based on the parameters of energy output or biological or environmental effects. In some embodiments, one advantage provided by the present invention is the use of a single console with a plurality of interchangeable reversibly connected therapeutic devices.

Description

THERAPEUTIC ENERGY SYSTEMS

TECH N ICAL FI ELD

001 The present invention relates to therapeutic devices.

RELATED APPLICATIONS

002 This application claims the priority of U .S. Provisional Patent Application Ser. No. 61/692228, filed on 22 August 2012, the contents of which are incorporated herein by reference.

BACKG ROU N D

003 The delivery of radio frequency ('RF') energy to target biological tissue is known for a variety of purposes. In one particular application, RF energy is delivered for ablating the target tissue.

004 Conventional RF devices comprise a console ( RF generator and controller) and a remova ble operational head (e.g. RF probe or RF catheter) configured for contacting the target tissue. A limitation of conventional RF devices is that each console is typically configured for only a limited num ber of operational heads. For example, at the time of purchasing new operational heads for a new technique, it is common to acquire, at the same time, a dedicated console. Consequently, there is a significant cost associated with purchasing, storing and maintaining a dedicated console for each of a large variety of operational heads. As an alternative, some consoles can accept a num ber of different operational heads; however, the controller must be re-programmed, re-calibrated or reset by the operator each time new unique operational head is introduced into the market or each time the operator wishes to change the output parameters of the generator.

005 Shah et al . ( US 7258688) describes one attempt to overcome these limitations by providing an RF generator that stores a plurality of operating modes specific to respective probe types. The RF generator further comprises an automatic probe type detector to ena ble the selection of the respective operating mode. Accordingly, the system described by Shah et al. is limited to probe types and modes pre-configured into the generator. Shah et al. do not teach storing the operating modes or control instructions on the probe. 006 Eubanks et al. (US 2011/0106004), describes interventional catheter assemblies, operating systems and adaptive interface components allow operation of a variety of interventional catheter assemblies, including infusion catheters, aspiration catheters and interventional catheters that provide both infusion and aspiration, using a common control console housing infusion and aspiration systems. Control instructions for operating the interventional catheter assembly and protocols for verifying system matches and operating conditions maybe encoded in hardware, firmware or software, such as a memory or storage device, provided in the interventional catheter assembly. Eubanks et al. fail to teach a catheter assembly comprising memory instructions for controlling user interface of a console. Further, Eubanks et al. fail to teach a catheter assembly comprising memory instructions for controlling RF output of a reversibly connected RF generator.

007 What is needed in the art is a flexible system enabling the use of a variety of different removable therapeutic devices with a common console.

SUMMARY OF TH E INVENTION

001 The invention provides a therapeutic system comprising: a console, wherein the console comprises a controller and an energy generator (e.g. RF generator); a therapeutic device comprising: an operational head configured for transmitting the energy output of the energy generator to the biological tissue; and a memory device comprising control instructions, wherein said control instructions comprise instructions for controlling the console ('control instructions');

a reversible memory operable linkage linking the memory device to the controller; and a reversible connector configured for operably linking the energy generator to the operational head.

002 The control instructions can comprise instructions for controlling any component of the therapeutic system. Optionally, the control instructions comprise instructions for controlling the output of the energy generator (e.g. the control instructions comprise parameters of energy output such as RF output). Optionally, the system further comprises a secondary device (e.g. Ul, sensor, or d/t device) and the control instructions comprise instructions for controlling the secondary device. Optionally the console comprises a user interface ('Ul') and the control instructions comprise instructions for controlling the Ul (e.g. . the control instructions for displaying limits of operation, therapy transition criteria, or parameters such as sensed parameters or parameters stored on the memory device.

Optionally, the control instructions that are operating head-specific, clinician-specific, or patient-specific).

003 Optionally, the control instructions comprise at least two sets of alternatively selectable control instructions (e.g. alternative instructions for controlling the energy output), for example, a first set configured for a first procedure and a second set configured for a second procedure.

004 Optionally, the energy generator is an RF generator, an ultrasound generator, a microwave generator, or a laser generator.

005 Optionally, the reversible connector comprises the reversible memory operable linkage, e.g. a wired communications linkage. Alternatively, the reversible memory operable linkage comprises a wireless communications linkage (e.g. electromagnetic or optical).

006 Optionally, the energy generator is an RF generator or other electromagnetic energy generator and the control instructions comprise one or more parameters of RF output or other energy output. Optionally, the one or more parameters of RF output or other energy output comprise one or more of: voltage, current, temperature, stimulation rate, pulse rate, pulse duration, ramp time, frequency, waveshape, and power.

007 Optionally, the system further comprises one or more sensors. Optionally, the reversible connector is configured for operably linking the one or more sensors to the controller. Optionally, the one or more sensors are configured for sensing or monitoring ('monitoring') one or more parameters. Optionally, the one or more parameters are selected from: an energy (e.g. RF) output parameter, an environmental condition, a biological condition), a therapeutic device condition (e.g. user input condition such as button, indicator, lever, or switch status). Optionally, the control instructions comprise instructions for controlling the sensor and/or for controlling the RF output (e.g. modulating RF output differentially) based on the monitored one or more parameters.

008 Optionally, the therapeutic device comprises an energy delivery head and at least one additional therapeutic head. Optionally, the control instructions further comprise instructions for controlling the at least one additional therapeutic head. Optionally, the at least one additional therapeutic heads are selected from: an irrigation head (e.g. cannula or lumen for connection to a fluid pump), an aspiration head (e.g. cannula or lumen for connection to a fluid pump), a lighting head, an expandable device, a cutting head, and one or more RF heads.

009 Optionally, the control instructions comprise one or more parameter values or one or more algorithms, e.g. for conducting a therapeutic procedure or otherwise controlling connected devices or providing instruction.

0010 Optionally, the control instructions comprise one or more parameters selected from energy output parameters, Ul output parameters, calibration parameters, verification parameters, capability parameters, and input parameters,.

0011 Optionally, the memory device is proximal to the reversible connector. Optionally, the memory device and the operable linkage share a common housing (e.g. plug housing).

0012 Optionally, the operational head is an RF ablation head. Optionally, the RF ablation head is a nerve a blator.

0013 Optionally, the therapeutic device comprises one or more of: a needle, a probe, a catheter, a patch, and a handpiece.

0014 Optionally, the operational head is configured for connection to or insertion into a patient. Optionally, the operational head comprises a needle, a blade, a patch, a cutting wire, an application plate, a catheter, or a probe.

0015 Optionally, the therapeutic system comprises a plurality of said therapeutic devices, wherein each therapeutic device is connected to a console by an independent reversible connector and each therapeutic device comprises a memory device reversibly linked to the console. Optionally, the second therapeutic device comprises a second memory device comprising control instructions, wherein said control instructions comprise instructions for controlling the second therapeutic device. Alternatively, a memory device of a first therapeutic device optionally comprises instructions for controlling a second therapeutic device of the system. Optionally, the second therapeutic device and the first therapeutic device share an operational head or comprise operational heads comingled together. Optionally, the second therapeutic device is a fluid pump.

0016 The invention also provides a therapeutic method using a system of the present invention. 0017 The invention also provides a device family comprising said system and a plurality of additional therapeutic devices, each comprising a unique set of control instructions. The invention also provides a method of a) selecting a first therapeutic device from the plurality; b) connecting the first therapeutic device to the console, c) performing a first therapeutic procedure with the first therapeutic device, d) removing the first therapeutic device from the console, and e) repeating steps a)-d) using a second therapeutic device of the plurality.

BRIEF DESCRIPTION OF THE DRAWINGS

0018 Figure 1A and IB depict examplary RF generators useful in the present invention.

0019 Figure 2 depicts an examplary system of the present invention.

0020 Figure 3 depicts an examplary therapeutic device useful in the present invention.

0021 Figure 4A and 4B depict examplary therapeutic devices useful in the present invention.

0022 Figure 5 depicts an examplary system of the present invention.

0023 Figure 6 depicts an examplary system of the present invention.

0024 Figure 7 depicts an examplary system of the present invention.

0025 Figure 8 depicts an examplary system of the present invention.

0026 Figure 9 depicts an examplary system of the present invention.

0027 Figure 10 depicts an examplary system of the present invention.

0028 Figure 11 depicts an examplary system of the present invention.

DETAILED DESCRIPTION OF TH E INVENTION

0029 As used here, the following definitions and abbreviations apply.

0030 "Examplary" (or "e.g." or "by example") means a non-limiting example.

0031 "Non-volatile memory" means memory that does not require power to retain stored information. Optionally, the memory device of the therapeutic device comprises nonvolatile memory.

0032 "Volatile memory" means memory requires power to retain stored data.

Optionally, the memory device of the therapeutic device comprises volatile memory and the therapeutic device comprises a battery configured for powering the memory device. The battery is optionally configured for continuously powering the memory device when the therapeutic device is not in use or not connected to the RF generator.

0033 "Controlling" means affecting the behavior and/or appearance of a system or a system component or the resulting outcome produced by that system or system component. Examples of optional system components include Ul (e.g. display such as a screen or an input such as a button), energy generators, operating heads (e.g. RF head), sensors, and any device connected to the console or therapeutic device. As another example, controlling a sensor can comprise receiving feedback from the sensor and affecting the behavior of another component based on said feedback.

Connector

0034 According to the present invention, at least one connector is provided for reversibly connecting a therapeutic device to a console. A connector useful for providing a reversible connection is also referred to herein as a 'reversible connector'. Such a connector can be configured in any manner that provides an operable linkage between the console (or component thereof) and the therapeutic device (or component thereof) upon connection of the therapeutic device to the console using the connector. The connector is configured to provide an operable linkage between the energy generator of the console and the operational head of the therapeutic device, thus providing a reversibly connected therapeutic device. Optionally, the system comprises one or more additional connectors for reversibly connecting one or more devices (e.g. a secondary device) to the console, e.g. by linkage directly to the console (e.g. to any console component) or by indirect linkage to the console (e.g. by linkage to a second console or other device that is itself linked to the first console, e.g. by a

communications link). Optionally, a connector used in the invention is configured to provide a plurality of operable linkages, e.g. any two, three or four members of the group consisting of a first energy linkage, a second energy linkage, a memory linkage, and a sensor linkage.

0035 Optionally, the connector comprises interacting couplers, at least one on the console side ('console-side connector') and at least one on the therapeutic device side ('therapeutic device-side connector'), or in the case of a secondary device, on an optional secondary device side ('secondary device-side connector'). Examples include a jack/plug configuration, e.g. wherein a plug is provided on the therapeutic device or a secondary device and a respective jack is provided on a console. In this configuration, a system is optionally provided with a plurality of therapeutic devices, each having a plug that interacts independently with the jack, e.g. to provide interchangeable therapeutic devices. Similarly, such interacting couplers can optionally be provided to connect interchangeable secondary devices to a console.

0036 Optionally, the connector comprises a plurality of terminals, e.g. a pin connector. Optionally, the connector is configured to simultaneously opera bly link a plurality of components of the therapeutic device (or secondary device) with the console upon connection of the connector. For example, the connector can be configured to simultaneously connect at least one energy delivery terminal, sensory linkage terminals, and optionally memory linkage terminals.

0037 Optionally, the connector comprises an operable linkage (e.g. electrical terminals for conducting RF output) connecting the energy generator to one or more electrodes of the operational head of the therapeutic device.

0038 Optionally, the connector comprises an operable linkage (e.g. communication bus) connecting the controller of the console to the memory device of a therapeutic device.

0039 Optionally, the connector comprises an operable linkage (e.g. electrical terminals) connecting an optional power source such a DC source, an AC source, or an AC/DC transformer of the console to one or more components (e.g. memory device) of the therapeutic device.

0040 Optionally, the connector comprises an operable linkage (e.g. cannula or tubing set) connecting an optional fluid pump of the console with a secondary device head (e.g. aspiration or infusion port) of the therapeutic device.

0041 Optionally, the connector comprises one or more cannulas. Optionally, the cannulas are configured to conduct a fluid such as a gas or liquid, or to deliver to a subject a device such as a stent or an implantable device.

0042 The connector is not limited to a connector having a particular type of operable linkage. Any operable linkages are useful in connectors. The configuration of operable linkages will, of course, depend on the nature of the component opera bly linked through the connector. For example, electrically conductive terminals can be used to provide operable linkages for connection one or more of: an RF generator, a controller, a power source, data communication connections or a display. As another example, a cannula can be provided as operable linkage to a fluid pump. The skilled artisan will recognize other operable linkages useful in the present invention.

0043 Optionally, a therapeutic device side connector or a secondary-device side connector comprises a memory device. Optionally, the therapeutic device side connector or a secondary- device side connector, or memory device thereof can be detached from the therapeutic device or secondary device. Such embodiments allow, for example, a user to easily remove the memory device from the therapeutic device and send the memory device (e.g. ship a small, lightweight memory device) to a second party (e.g. manufacture) for inspection or retrieval of data (e.g. a procedure log recorded on the memory device) 0044 Optionally, the connector comprises interacting couplers, at least one on the console side and at least one on the therapeutic device side, wherein the interacting couplers are configured to provide one or more of: a. Feedback of connection status such as tactile feedback (e.g. "snap" upon

successful connection) or illumination feedback (e.g. light upon successful connection); b. magnetic coupling (e.g. magnets of opposite polarity placed on the console side and therapeutic device side); c. visual alignment (e.g. marks on the console side and therapeutic device side that align upon successful connection); d. mechanical alignment and coupling (e.g. male/female couplers); e. thermal reference for temperature sensing; f. thermal coupling; g. fluid alignment; h. a locking mechanism; and i. a reuse control mechanism

Console

0045 A system of the present invention comprises at least one console comprising an energy (e.g. RF) generator and a controller, wherein the console is configured for accepting the connector for operably linking a therapeutic device to the console.

0046 Optionally, the console further comprises a user interface ('Ul'). Optionally, the user interface comprises a display and/or a user input device.

0047 Optionally, the console further comprises a display. Optionally, the display is a screen, e.g. LCD screen or projector (e.g. pico-projector).

0048 Optionally, the console further comprises a user input device. Optionally, the user input device comprises one or more of: a keyboard, keys, a touch-screen, a switch, a wheel, a mouse, voice and audio recognition device, foot switch, hand control, retinal scanner, a clapper and a dial. 0049 Optionally, the console further comprises a housing. Optionally, the housing is configured for accepting the connector (e.g. comprises a jack for the connector). The housing optionally encloses one or more of: the RF generator, the controller, a display, and a user input device.

0050 Optionally, the console further comprises a power supply. Optionally, the power supply is a battery or an AC/DC transformer.

0051 Optionally, the console further comprises a local memory device (also referred to herein as 'console memory').

0052 Optionally, the console is a computer. Optionally, the computer comprises a. a processor, e.g. microprocessor configured for use as the RF generator controller or a microprocessor in communication with the RF generator controller; b. a local memory device; c. a connector configured for connection to the connector of the therapeutic device; and d. a structure (e.g. a motherboard or other circuit board) configured for operably linking the processor to the other components of the computer (e.g. local memory device, RF generator, and connector).

0053 Examplary consoles of the present invention are configured to provide one or more of the following functions: a) Attachment to (e.g. through a connector) a removable therapeutic device, such as a needle, probe, catheter, patch, handpiece, wire, plate, mesh, balloon through which energy such as RF energy is applied to a patient;

b) Delivery of a range of therapeutic energies to a patient via the therapeutic device; c) Monitoring a plurality of energy monitoring, biological, physiological, physical and environmental parameters relevant to the patient's treatment and convert these into computer-readable data;

d) Providing a user input device to the operator to initiate, alter, or halt the delivery of energy such as RF energy to the patient; e) Providing a user interface (e.g. text, graphics, and/or sounds) that presents feedback to the operator regarding the status of energy delivery and the monitored parameters; f) Starting, stopping, or changing energy delivery based on the monitored parameters; g) Providing warning, alerts, alarms, or other advice to the operator based on the

monitored parameters; and

h) Reading data stored in the memory of an attached therapeutic device;

0054 In one embodiment, the invention provides a system comprising a plurality consoles connected by a data link between controllers ('communications link'). Optionally, the plurality at least comprises a first console configured to provide a first medical function (e.g. diagnostic or therapeutic function) and a second console configured to provide a second medical function. The medical functions are optionally any medical functions provided by a d/t device (e.g.

therapy such as energy delivery or sensing such as imaging) Each of the first and second consoles are optionally reversibly or non-reversibly connected to a d/t device such as a therapeutic device or diagnostic device for control thereof. The controllers of the first and second consoles can be configured to provide coordinated medical functions, for example, by providing control instructions on memory such as console memory or therapeutic deice memory of a connected therapeutic device. The first and second medical functions are each optionally a therapeutic function (e.g. energy generation) or a diagnostic function (e.g.

imaging). Optionally, at least the first console is reversibly connected to a therapeutic device. Optionally, the second console is reversibly connected to a therapeutic device or a diagnostic device. Examples of useful console combinations include ablation/irrigation, ablation/imaging (e.g. as detailed in Example 18), and vaporization/ventilation (e.g. as detailed in Example 16).

Energy Generator

0055 A system of the present invention comprises at least one energy generator configured for control by a controller. Useful energy generators include any generator of therapeutic energy or diagnostic energy.

0056 Optionally, the system comprises an energy generator configured to provide a therapeutic energy selected from electromagnetic energy, mechanical energy, thermal energy, and electrical energy.

0057 Optionally, the system comprises an energy generator configured to provide electromagnetic energy selected from RF energy, microwave energy, and light energy (e.g. laser). 0058 Optionally, the system comprises an energy generator configured to provide mechanical energy selected from irrigation (e.g. fluid pump for cooling), pneumatic pressure (e.g. ventilator for ventilation, compression sleeve), inert gas pressure (e.g. insulfation) and sonic energy (e.g. ultrasound generator for therapy).

0059 Optionally, the system comprises an energy generator configured to heat or ablate a target biological tissue. For example, the system can comprise an RF generator, an ultrasound generator, a microwave generator, a cryoablation generator, or a laser generator.

0060 Optionally, the system comprises an energy generator configured to produce diagnostic energy. Examples of useful diagnostic energy include imaging energy such as an electromagnetic imaging energy. Useful imaging energies include magnetic energy or RF imaging energy (e.g. as in an MRI device) and X-ray energy (e.g. as in CAT, PET, and fluoroscopy devices).

0061 Optionally, the system comprises an RF generator. The RF generator can comprise any RF energy source. Optionally, the RF energy source is an RF oscillator. The RF generator can be configured to produce any RF energy. Optionally, the RF energy is ablation energy or cutting energy.

0062 Optionally, the RF generator is configured for producing RF energy at a plurality of frequencies, amplitudes, crest factors, and/or pulse characteristics.

0063 Optionally, the RF generator comprises one or more RF modulators, e.g. an amplitude modulator, a pulse modulator, and/or a frequency modulator.

0064 Optionally, the RF generator is configured for operating in a frequency range of about 80 kHz to about 15 MHz.

0065 Optionally, the RF generator is configured to operate in a sinusoidal or a non- sinusoidal wave form.

0066 Optionally, the RF generator is configured to operate with a power output in the range of about 1 W to about 500 W.

0067 Optionally, the RF generator comprises a plurality of output channels. Additionally or alternatively, the console comprises a plurality of RF generators.

0068 An examplary RF generator useful in the present invention comprises an RF energy source such as an RF oscillator, wherein the RF generator is configured for amplifying and modulating the RF energy. The RF generator is configured for producing RF energy at a plurality of frequencies, e.g. by providing an RF oscillator with variable frequency output or by providing an RF frequency modulator coupled to the RF oscillator. The generator can be configured, e.g. as depicted in Figure lA or B.

0069 The RF generator can be controlled by any controller. Optionally, the controller of the RF generator is the same controller that communicates with the memory device of a connected therapeutic device. Alternatively, the controller of the RF generator is optionally configured to be in communication with a one or more controllers configured to access the memory device of a therapeutic device.

Controller

0070 A system of the present invention comprises at least one controller configured to: a. access data stored on a memory device (e.g. memory device of a connected therapeutic device), wherein the data comprises control instructions; and b. control at least one console component (e.g. energy generator) according to the control instructions.

0071 Any controller is useful in the present invention. Optionally, the controller comprises a microcontroller such as a microprocessor. Other useful controller types include

reconfigurable logic devices such as FPGA, CPLD, special-purpose computing engines such as graphics processing units (GPU), process controllers such as a PLC, and operational amplifier circuits, etc.

0072 In general, the controller can be configured to control (i.e. send data or analog signals to and/or receive data or analog signals from) input or output (Ί/Ο') devices of the system such as the energy (e.g. RF) generator; the memory device of the therapeutic device (also referred to herein as 'therapeutic device memory' or the 'memory device'); and optional devices of the system such as a sensory- or therapeutic- type device (e.g. fluid pump or an additional energy generator), a local memory device ('local memory'), a user interface (e.g. user input device and/or user output device).

0073 The controller can optionally be a single controller connected to and configured to control the I/O devices or, or alternatively, can comprise a collection of controllers in communication with each other or with a common controller. Optionally, the controller comprises two or more independent controllers selected from: an energy (e.g. RF) generator controller, a memory device controller, a serial or parallel device controller, and a display controller. Optionally, the controller comprises a primary controller (e.g. microprocessor such as those used in desktop computers) and one or more secondary controllers, wherein each of the one or more secondary controllers is controlled by the primary controller and in-turn controls a console device (e.g. energy generator controller).

0074 Optionally, the controller is configured for controlling a user interface. Optionally, the user interface comprises an output device and/or an input device. Examples of useful output devices include a graphic user interface ('GUI') or a non-graphical user interface such as an LED or text-based display. .

0075 Optionally, the controller is configured for controlling a display (e.g. screen).

0076 Optionally, the controller is configured for controlling an input device. Examples of useful input devices include a user input device and a sensor. The controller can control an input device, e.g. by receiving data or feedback (e.g. analog electrical feedback such as voltage or resistance induced by a temperature sensor or other input device) and performing a designated function (e.g. controlling another component or computing a sensed condition such as temperature).

0077 Optionally, the controller is configured for controlling a user input device. Examples of user input devices include key-type inputs (e.g. keyboard), mouse, footswitch, and touchscreens.

0078 Optionally, the console comprises memory local to the controller. The memory can be configured to provide one or more or all of the following: a) Basic operating-system services such as storing files, creating standard interfaces, executing programs.

b) Low-level control and monitoring of Therapeutic RF or other energy delivery.

c) Low-level control and monitoring of the monitored parameters.

d) Display text and images to the display.

e) Sound audio from speakers.

f) Communicate with standard networking and communication interfaces such as

Ethernet, USB, Firewire.

g) Export patient and treatment history information to networking interfaces. h) Export patient and treatment history information to operator-removable mass storage devices such as a USB Mass Storage device.

i) Export patient and treatment history information to printers.

j) Add, replace, or modify software or control instructions contained one the memory of the therapeutic device.

k) A framework for retrieving an algorithm or parameter from the therapeutic device and executing the algorithm to control the operation of the console or therapeutic device (e.g. configuration management software, or a script interpreter).

Energy generator control

0079 According to the present invention, at least one controller is configured to control the output of the energy (e.g. RF) generator according to the control instructions on the memory device of a connected therapeutic device.

0080 Optionally, the controller is configured to control one or more energy (e.g. RF) output parameters selected from: pulse parameters (e.g. pulse duration and/or pulse frequency), amplitude, energy frequency, and wave shape. Optionally, the value of the one or more energy (e.g. RF) output parameters is obtained from the memory device.

0081 Optionally, the controller is configured to modulate the output of an RF energy source. Optionally, the controller is configured to control a modulator of RF output.

Optionally, the modulator is selected from an amplitude modulator, a pulse modulator, a frequency modulator, or a combination thereof. Alternatively, the controller is optionally configured for modulating an energy source of the energy generator, e.g. to produce a modulated waveform directly. Optionally, the controller is configured to obtain control instructions for said modulating from the memory device.

0082 Optionally, the controller is configured to carry out an algorithm comprising a plurality of steps, wherein at least one of the steps comprises controlling the energy (e.g. RF) generator. Optionally, the algorithm, or portion thereof, is stored on and obtained from the memory device. Alternatively, the algorithm is optionally stored locally and comprises one or more variables (e.g. parameter variables), wherein the values of the one or more variables are obtained from the memory device. 0083 Optionally, the controller is configured for carrying out an algorithm, wherein the algorithm or portion thereof is stored on the memory device of a connected therapeutic device. Optionally, at least one of the steps comprises controlling the energy (e.g. RF) generator.

0084 Optionally, the controller is configured for carrying out an algorithm stored locally, wherein the algorithm comprises one or more variables (e.g. parameter variables), wherein the values of at least one of the one or more variables are stored on the memory device. The controller is configured to obtain the values from the memory device and set the variables using the values.

0085 Optionally, algorithms carried out by the controller comprise a plurality of steps, including therapeutic steps and optional sensing steps, wherein at least one of said steps comprises controlling the energy (e.g. RF) generator.

0086 Optionally, instructions for controlling the energy generator are provided on a memory device of a reversibly connected therapeutic device.

0087

Memory device control

0088 According to the present invention, at least one controller is configured for accessing data stored on the memory device of a connected therapeutic device.

0089 Optionally, the controller is configured to obtain control instructions from the memory device, e.g. a set of parameter values, one or more algorithms, or a combination thereof.

0090 Optionally, the controller of the console is configured to directly access a memory device of a connected therapeutic device (e.g. the connector provides operable linkage directly to console controller from the memory device). Alternatively, the therapeutic device optionally comprises an independent controller configured to access the memory device and

communicate data therefrom to the controller of the console (e.g. the connector provides operable linkage to console controller from a controller of the memory device).

0091 Optionally, instructions for controlling the memory device of a therapeutic device are provided on a local memory device.

0092

User Output Control 0093 Optionally, at least one controller is configured for controlling a user output graphic interface. Optionally, the controller comprises one or more independent user output controllers (e.g. graphics microprocessor) for controlling the user output.

0094 Optionally, the user output comprises one or more of: a speaker, a graphic interface. Optionally, the graphic interface is a display, a projector, a screen, or a device comprising one or more LEDs, LCDs, CRTs, or VFDs.

0095 Optionally, the controller is configured to display data stored on the memory device of the therapeutic device. Optionally, the displayed data comprises one or more of: ID code or identifier of the therapeutic, manufacture date of the therapeutic device, expiration date of the therapeutic device, use data of the therapeutic device, settings adjusting the energy delivery or treatment, or control instructions (e.g. parameter values).

0096 Optionally, the controller is configured for controlling a user output based on the control instructions of the memory device. For example, the control instructions can be configured to specify a parameter of user output such as text size, graph axes, update rate, filtering, color, units of values, precision of values, acceptable ranges of values, and value or conditioning of sensor signals to trigger alarms or alerts. Additionally or alternatively, the control instructions can comprise a trigger parameter (e.g. temperature, ECG, or heart rate) which triggers a step of controlling (e.g. displaying or alerting via) the user output device.

0097 Optionally, the controller is configured for displaying a real-time report or a postprocedure report, e.g. a report of any of: parameters stored on the memory device or sensed parameters or energy output parameters encountered during a therapeutic procedure.

0098 Optionally, the controller is configured for presenting (e.g. visually or audibly) input sensed during a therapeutic procedure.

0099 Optionally, instructions for controlling the user output device are provided on a memory device of a reversibly connected therapeutic device.

00100

User Input Device Control

00101 Optionally, at least one controller is configured for controlling a user input device. Optionally, the user input device comprises a one or more of: a keyboard, keys, a touch-screen, a switch, a wheel, a mouse, voice and audio recognition device, foot switch, hand control, retinal scanner, a clapper and a dial.

00102 Optionally, the user input device is provided on the console or on the therapeutic device.

00103 Optionally, instructions for controlling the user input device are provided on a memory device of a reversibly connected therapeutic device.

Secondary device control

00104 Optionally, the controller is configured to control one or more secondary devices. Useful secondary devices include any device that provides a sensory function (e.g. temperature sensor, force sensor, or imaging device) or therapeutic function (e.g. irrigation). .

00105 The controller can be configured to control one or more secondary devices in any manner. Optionally, the controller is configured to obtain control instructions for controlling the secondary device from the memory device of the therapeutic device. Optionally, the memory device of the therapeutic device comprises instructions for controlling an energy generator and instructions for controlling a secondary device. Optionally, the control instructions comprise an algorithm comprising at least one step of controlling the secondary device and at least one step of controlling the energy generator. Optionally, at least one of said steps is dependent on at least one other step (e.g. controlling irrigation dependent on temperature, or controlling an energy generator dependent on temperature or contact force).

00106 Optionally, the one or more secondary devices comprise a sensor (e.g. environmental sensor such as a temperature sensor or ECG) and controlling the sensor optionally comprises obtaining feedback from the sensor.

00107 Optionally, the one or more secondary devices comprise a secondary therapeutic device (e.g. fluid pump or expandable device) and controlling the secondary therapeutic device comprises initiating, terminating, or modulating output of the secondary therapeutic device.

Therapeutic Device

00108 According to the present invention, a therapeutic device can be connected to a console to operate the therapeutic device. The therapeutic device comprises an operational head, a memory device, and a therapeutic device-side connector for operable linkage to a console-side connector. Optionally, the therapeutic system comprises a plurality of therapeutic devices, each with a different operational head. 00109 Optionally, the therapeutic device comprises one or more secondary devices (e.g. a sensor or a device with a therapeutic function).

00110 Optionally, the therapeutic device comprises a connecting cable connecting the operational head to the connector.

Operable Linkage

00111 According to the present invention, the therapeutic device is operably linked to a console. Components of a therapeutic device (e.g. the operational head and the memory device) can be operably linked to the console in any manner that allows control of the components by the console. Accordingly, a system of the invention comprises, as operable linkages, at least one communications linkage (e.g. memory operable linkage for transmitting data from a memory device) and at least one energy linkage (e.g. wires for transmitting RF energy).

00112 Optionally, the operable linkage further comprises one or more of: an electrical power linkage, a mechanical linkage, and a secondary device linkage.

00113 Optionally, the operable linkage comprises an electrical power linkage. For example, operational heads which require electrical power can be connected to the console via electrical wiring of the therapeutic device operably linked through the connector. Alternatively, operational heads which require electrical power can comprise a battery and a communications linkage to the console.

00114 Optionally, the energy linkage is configured for transmitting energy selected from RF energy, ultrasound energy, laser energy, and microwave energy.

00115 Optionally, the communications linkage comprises any wired or wireless linkage configured for transmitting data to or from the operational head or the memory device of the therapeutic device. For example, a wired communications linkage can be provided in the connector of the therapeutic device, or alternatively, the console and the therapeutic device can each comprise a wireless transmitter or receiver configured to communicate with each other (e.g. electromagnetic linkage based such as Bluetooth communications linkage or optical linkage)

00116 Optionally, the operable linkage comprises a mechanical linkage. The mechanical linkage can be any linkage that imparts movement at the operational head by a driver (e.g. motor, solenoid, piezo transducer, cylinder, pneumatic pump or fluid pump) optionally provided in the console. Optionally, the mechanical linkage is provided through the connector of the therapeutic device. Optionally, the mechanical linkage comprises a cannula (e.g. for conducting a fluid as in aspiration or infusion or to power hydraulically powered instruments), or one or more levers, gears, cams, cranks, springs, belts, or wheels.

00117 Optionally, the operable linkage comprises a secondary device linkage. The secondary device linkage can be any linkage configured to allow control of a secondary device. Optionally, the secondary device linkage comprises a therapeutic device linkage or a sensory device ("sensor") linkage. For example, one embodiment provides a therapeutic device comprising a sensor (e.g. temperature sensor), and the therapeutic device comprises a sensory device linkage configured to transmit feedback from the sensor (e.g. electrical wires for electrical current- or voltage- based feedback).

Operational Head

00118 A therapeutic device useful in the present invention comprises one or more operational heads. The operational head is any component that is operably linked to the console and interacts with (e.g. contacts) a patient to provide a therapeutic or sensory function. According to the present invention, the therapeutic system comprises at least one therapeutic device comprising an operational head, wherein the operational head comprises an energy (e.g. RF) delivery head as an operational head.

00119 Optionally, the energy delivery head is selected from: an RF head, an ultrasound head, a laser head, and a microwave head. Optionally, the energy delivery head is an RF head comprising one or more RF electrodes.

00120 Optionally, the operational head comprises a secondary device, e.g. a sensor, a device with a therapeutic function, or a combination thereof.

00121 Optionally, the operational head (e.g. RF head) comprises one or more of: a catheter, a hand tool, forceps, a needle, a probe, a plate, a blade, and a wand.

00122 Optionally, the therapeutic device comprises at least one therapeutic head selected from: a second energy delivery head (e.g. RF ablation head), an expandable device, an aspiration or infusion head, a compression head, an irrigation head, a lighting instrument, a medication head, a cauterizing head, a saw, and a blade.

00123 Optionally, the therapeutic device comprises an irrigation head. Optionally, the irrigation head is a closed irrigation loop head or an open irrigation head. Optionally, the therapeutic device comprises a singly maneuverable device comprising an energy delivery head and an irrigation head (e.g. an irrigated ablation catheter such as an open-loop or closed irrigation catheter).

00124 Optionally, the therapeutic device comprises at least one sensory head (e.g. a sensor configured to sense an environmental effect at a target site or a biological effect on a patient). For example, the at least one sensory head can comprise a sensor of any parameter taught herein, e.g. a sensor of energy (e.g. RF) output, a sensor of an environmental condition (e.g. temperature or humidity), a biological signal (e.g. respiration, ECG or EMG), or a force sensor (e.g. contact force sensor of energy delivery head).

00125 Optionally, the therapeutic device comprises at least one sensory device ('sensor') selected from: a temperature sensor, a heart rate sensor, an EMG head, an ECG head, a pressure sensor, a voltage sensor, an imaging head, a current sensor, an impedance sensor, a sensor of RF output (e.g. any RF output parameter), a chemical sensor, a fluid flow sensor, imaging sensor within a balloon catheter (e.g. fiber optic imager). Useful sensory signals can be provided about (e.g. in or on) an energy delivery head (e.g. temperature sensor in the tip of an ablation catheter) or provided on a separate operational head (e.g. a heart rate sensor in a location remote to an ablation catheter).

00126 Optionally, the therapeutic device comprises a temperature sensor. Examples of useful temperature sensors include thermistors, resistance temperature detectors (RTD), and thermocouples. A temperature sensor can be operably linked to the console controller, e.g. by a pair of wires. Optionally, through such a temperature sensor linkage, the controller can receive feedback from the temperature sensor indicative of the temperature, e.g. temperature- dependent voltage of a thermocouple or temperature-dependent resistance of a thermistor. Optionally, a temperature sensor is provided about an energy delivery head (e.g. in an ablation catheter). Optionally, the therapeutic device comprises an RF head, at least one sensory device configured for monitoring an environmental condition and at least one sensory head configured for monitoring RF output.

00127 Optionally, the operational head is configured for insertion into a subject. For example, the operational head can comprise a catheter, tube, introducer, or a needle configured for contact with or insertion into a subject. 00128 Optionally, the therapeutic device comprises one or more therapeutic heads selected from: an RF head, an expandable device (e.g. balloon), an aspiration or infusion head, an irrigation head, a lighting instrument, a medication head a cauterizing head, a saw, and a blade.

00129 Optionally, the operational head comprises a therapeutic head and a sensory head (e.g. a temperature sensor, force sensor, or both). Optionally, the operational head comprises an energy delivery (e.g. RF) head and an irrigation head. Optionally, the operational head comprises an energy delivery (e.g. RF head), an irrigation head, and a sensory head. For example the operational head can be an irrigated catheter (e.g. open loop or closed loop) comprising an energy delivery (e.g. RF) electrode on the outer tip of the catheter and optionally one or more sensors in or on the catheter tip.

00130 Optionally, the therapeutic device comprises a plurality of operational heads joined or formed together as a single device that can be maneuvered into contact with a patient. For example, a plurality of therapeutic heads and/or sensors (e.g. an energy delivery head, an irrigation head, and a temperature sensor can be combined into a single maneuverable device (e.g. catheter).

00131 Examples of useful operational heads such as energy delivery catheters and useful combinations of heads (e.g. energy delivery, sensory, and irrigation) are taught by US

5,913,856, US 7,591,816, US 20030004506, and US 6210406.

RF Head

00132 According to the present invention, the therapeutic device optionally comprises an RF head as an operational head. The RF head can be any device that transmits radio frequency energy from a connected RF generator to a subject. Examplary RF heads of the present invention comprise an RF heating heads such as an RF ablation head, an RF fulguration head, an RF coagulation head, or RF cutting head.

00133 Optionally, the RF head comprises one or more electrodes operably linked (e.g. electrically linked) to an RF generator of the console for delivering RF energy from the RF generator to tissue. Optionally, the RF head is a monopolar head, a bipolar head or a combination of both (e.g. phased array).

00134 Optionally, the RF head is a thermal RF head. The thermal RF head can be any RF head configured to deliver RF energy having a heating effect, for example configured to cause ionic agitation, or friction, increasing the temperature of a target material. For example, the RF head can be configured to heat tissue or other materials. Optionally, the thermal RF head is any of: an RF ablation head, an RF cutting head, or an RF coagulation head.

00135 Optionally, the RF head is a RF ablation head. The RF ablation head can be any RF head configured to deliver RF energy having an ablating effect.

00136 Optionally, the RF head comprises a catheter, a hand tool, forceps, a needle, or a wand.

00137 Optionally, the RF head comprises a catheter. An RF catheter can comprises, for example, a cannula with an RF electrode exposed at the tip. Useful RF catheters are taught, for example, by US 5,913,856, US 7,591,816, US 2003/0004506, and US 6210406.

00138

00139 RF heads such as RF ablation heads can be configured in any manner. For example, an RF head can comprise at least two electrodes: a transmitting electrode for delivering energy and a return electrode for the return of the energy. The RF head can be configured as a monopolar head or a bipolar head. A monopolar RF head comprises a transmitting electrode configured for placement in proximity to a target tissue and a return electrode (sometimes referred to as an indifferent electrode) configured for placement distally to the target tissue (e.g. placement on the patient's skin, e.g. using a skin patch electrode). A bipolar RF head can comprise a transmitting electrode and a receiving electrode both in proximity to the target tissue. A head may optionally contain a plurality of electrodes which alternate polarity, phase, or connectivity to provide selective treatment.

00140 Electrodes of an RF head can be made of any electrically conductive material.

Examples include gold, silver, carbon, platinum, platinum-iridium, nickel titanium, and stainless steel.

00141 Although RF heads and RF generators are provided in examplary systems, the invention also contemplates therapeutic systems having any energy delivery head and any energy generator. Accordingly, any of the RF heads taught herein can alternatively be configured as any other electromagnetic energy (e.g. microwave) delivery head and provided in a system with a console having the appropriate energy generator.

Memory Device 00142 According to the present invention, a therapeutic device comprises a memory device comprising control instructions as data. The memory device can be configured in any manner that that allows communication between the memory device and a controller when the connector of the therapeutic device is connected to the controller or a console comprising the controller.

00143 Any memory device is useful in the present invention.

00144 The memory device can comprise any memory type. Useful memory types include non-volatile and volatile memory.

00145 Optionally, the memory device comprises non-volatile memory. Optionally, the nonvolatile memory is selected from read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), flash memory, battery-backed- up random access memory (RAM), non-volatile RAM, ferro-magnetic RAM, magnetic data storage apparatus, including tape drives and disk drives, optical data storage apparatus, electrically erasable programmable read only memory (EEPROM), an SD card (e.g. SDHC, SDXC, or SDSC), a USB device (e.g. Universal Serial Bus ( USB) 1.1, USB 2.0 or USB 3.0), or devices substantially identical to an SD or USB device but contained in a non-industry-standard package.

00146 Optionally, the memory device comprises EEPROM. The EEPROM can be, e.g. any non-volatile, semiconductor memory device comprising memory cells which may be written to and erased on a byte-by-byte basis. Examples of useful EEPROM memory include SPI or I2C EEPROM memory.

00147 Optionally, the memory device comprises flash memory. The flash memory can be, e.g. any non-volatile, semiconductor memory device that is erasable only in block. Examples of useful flash memory include SPI, SD, USB or I2C flash memory

00148 Optionally, the memory device is configured in any manner that allows the data (e.g. parameters or algorithms) on the memory device to be read by the controller but not modified by the controller. This configuration, e.g., prevents users from purposefully or accidentally modifying, updating, or overwriting the data.

00149 Optionally, the memory device is operably linked to the connector of the therapeutic device. In this embodiment, the memory device is configured in any manner such that, upon connection of the connector to a controller (e.g. plugging the therapeutic device into a console comprising the controller and an RF generator), the controller can access the memory device. Optionally, the connector comprises communication wires for connecting the memory device to the controller. Optionally, the connector comprises powered wires for powering the memory device.

00150 Optionally, the memory device is removable connected to the therapeutic device. Optionally, the memory device comprises a personal computer type connector (e.g. USB, firewire, or serial connection). In this embodiment, the memory is optionally configured to allow transfer of data to a personal computer, e.g. upon disconnecting the memory device from the therapeutic device and connecting to a computer.

Controller

00151 Optionally, the therapeutic device comprises a controller for controlling the memory device or the operating head of the therapeutic device. The controller can be any controller (e.g. microprocessor).

00152 Optionally, the controller of the therapeutic device is configured to control (e.g. read from or read from and write to) the memory device or the operating head of the therapeutic device and communicate with the controller of the energy (e.g. RF) generator when the connector of the therapeutic device is connected to the controller of the RF generator.

00153 Optionally, the controller of the therapeutic device is configured to modify (e.g. write to) the memory device or the operating head of the therapeutic device and communicate with the controller of the energy (e.g. RF) generator when the therapeutic device is connected to the console.

00154 Optionally, the controller of the therapeutic device is configured to control one or more optional secondary devices (e.g. sensor or device with a therapeutic function).

Cable

00155 Optionally, the therapeutic device comprises a cable operably linking the connector to the operating head or memory device.

00156 Optionally, the cable comprises one or more electrical wires operably linked to the connector such that the RF generator can transmit RF energy through said electrical wires. 00157 Optionally, the cable comprises one or more communication wires operably linked to the connector such that the controller of the RF generator can communicate with the memory device or controller thereof.

00158 Optionally, the cable comprises one or more sensing wires operably linked to the connector such that the controller of the energy (e.g. RF) generator can receive information from the operating head (e.g. temperature information from a thermocouple).

00159 Optionally, the cable comprises one or more cannulas or lumens for carrying fluids (e.g. liquids or gases) or other materials to and from the operating head.

Data

00160 According to the present invention, the memory device of a therapeutic device comprises data specific to the therapeutic device, a procedure for which the therapeutic device is configured, or a secondary device comprised by the system. The data includes control instructions, wherein the control instructions comprise instructions for controlling the console. Optionally, the control instructions comprise instructions for controlling one or more of: the energy (e.g. RF) generator, an optional secondary device (e.g. sensor, imaging device, U l, and/or second therapeutic device), or any an optional I/O device such as a peripheral, a personal computer, or a second console.

00161 Optionally, the system comprises a secondary device and the therapeutic device memory further comprises instructions that are specific to the secondary device or a procedure for which the secondary device is configured). Additionally or alternatively, the optional secondary device comprises memory device having control instructions (e.g. control instructions specific to the secondary device or a procedure for which the secondary device is configured).

00162 The instructions for controlling the console can comprise any instructions that cause the console controller to control (e.g. send or receive data or analog signals to or from) a console device (e.g. energy generator) or an I/O device connected to the console or communicate with (e.g. send raw or interpreted instructions to) a second controller such as a controller of a second console.

00163 Optionally, the control instructions comprise one or more parameters, one or more executable instructions, or both. 00164 Optionally, the control instructions comprise executable instructions such as algorithms, control software, or scripts. Additionally or alternatively, the control instructions optionally comprise parameters that are input into executable instructions (e.g. general algorithms that reference the parameters) stored on the therapeutic device memory, an optional console memory device, or an optional secondary device memory.

00165 Optionally, the control instructions comprise one or more parameters. Optionally, the parameters comprise one or more of output parameters (e.g. energy output parameters and/or Ul output parameters), input parameters (e.g. monitored parameters), calibration parameters, verification parameters, and capability parameters.

00166 Optionally, the control instructions comprise an operating mode characterized by a plurality of energy (e.g. RF) output parameters.

00167 Optionally, the control instructions comprise instructions for controlling or interacting with one or more secondary devices of the system or therapeutic device.

00168 Optionally, control instructions may be machine readable (i.e. binary executable instructions), scripted (i.e. written in a format interpreted by the controller), select from predefined actions or database of actions available to the controller, source code (i.e. compiled and the executed by the controller), or a combination thereof.

00169 Optionally, the data further comprises an ID code. The ID code can be any identifier of the therapeutic device or operational head thereof. For example, the ID code can be a serial number. An ID code can be used, e.g. to identify the type of therapeutic device to the controller or a user thereof, to identify predetermined operating parameters or executable instructions stored locally to the controller (e.g. in a lookup table comprising the ID code stored locally to the controller), to identify the facility in which the therapeutic device was used or is intended for use, to identify the facility in which the therapeutic device was manufactured, to identify a clinician by whom the therapeutic device was used or is intended for use, to identify the region for which the therapeutic device was manufactured or intended for use, to identify a brand, division or company associated with the therapeutic device, to identify a console or console software version for which the therapeutic device or data of its memory is configured.

00170 Optionally, the therapeutic device memory device or data thereof comprises one or more of copy-protection, a console software update, region protection, expiration protection, and reprocessing protection. 00171 Optionally, the therapeutic device memory comprises a console software update. For example, the memory device can comprise, complete software updates of the console, including operating system and applications, partial updates of the console software, include some elements of operating system and applications, graphics or display resources customizable elements per customer, changes in workflow rules (i.e. require operator to confirm parameter before beginning therapy), updates of keys (symmetric or asymmetric) which will be used to authenticate future devices, updates of keys (symmetric or asymmetric) which when authenticated by another operator action (such as entering a code) allow the console to be used for a specific number of treatments, updates of the number of uses which the console may perform before requiring a further authorization, or scripts or instructions to copy diagnostic or historical data from the console to the memory device.

00172 Optionally, the data is stored in an encrypted form, which is readable only by an authorized console or an authorized computer. This configuration can be used, e.g. in preventing theft of algorithms and counterfeiting of therapeutic devices.

00173 Optionally, the data stored is encrypted such that is readable only by a subset of consoles, preventing use by unauthorized consoles.

00174 Optionally the encryption is symmetric or asymmetric encryption.

00175 Optionally the encryption may require a challenge-response sequences between the console and therapeutic device.

00176 Optionally the controller may modify the data stored on a therapeutic device so that it is rendered unauthorized for all or a subset of consoles.

00177 A set of control instructions can be tailored, for example, to a specific therapeutic device, energy delivery head (e.g. RF catheter), a specific region (e.g. geographic region), and/or therapeutic procedure.

00178 A system of the invention can comprise one or more memory devices comprising data, wherein at least one of said memory devices is comprised by a therapeutic device.

Collectively, the data is configured to at least cause the system to produce a therapeutic or diagnostic effect. Optionally, the system comprises at least one additional memory device such as a console memory device, a memory device of an optional secondary device, or both.

Optionally, the system comprises a single memory device comprising all of the data (e.g.

control instructions) required by the system to function. Alternatively, the system optionally comprises a plurality of memory devices that collectively comprise the data. Optionally, the system comprises at least one additional memory device such as a console memory device, a memory device of an optional secondary device, or both. Optionally, the therapeutic device memory or optional secondary device memory comprises control instructions specific to a device or procedure and the console comprises a memory device comprising system software (e.g. operating system and/or general algorithms) configured for obtaining, interpreting, and/or carrying out the control instructions stored on the therapeutic device.

00179 Although the data taught hereinabove are advantageously provided on therapeutic device memory or secondary device memory, the invention also contemplates embodiments in which some data is provided on therapeutic device memory or secondary device memory and some data is provided on console memory.

00180 Examplary data useful in the memory device of a therapeutic device is configured to specify to the controller one or more (e.g. each) of the following: a) The conditions which must exist as defined by the therapeutic device, monitored

parameters, and console hardware (e.g. RF generator) to initiate a therapeutic procedure.

b) How the RF energy delivered to the patient is controlled; the algorithms which adjust the amount, rates, and duration of the energy delivered to the patient.

c) The parameters which are monitored and how they affect the RF energy to be

delivered; the feedback inputs and gains into the algorithms.

d) The parameters which are to be displayed to the operator via the user interface.

e) The representation (i.e. textual, graphical, refresh rates) and format of the parameters displayed to the operator via the user interface.

f) The parameters which the operator is allowed to modify the treatment and the ranges within said parameters can be modified.

g) The conditions of RF energy output, or the monitored parameters which cause an

algorithm to adjust to a new phase or type of energy delivery with different amounts, rates, or durations.

h) The conditions of RF energy output, or monitored parameters which cause the change in operator of other connected equipment (e.g. changing the flow rate of an infusion pump connected to the generator via the USB or Ethernet interfaces) i) The changes in the representation of the parameters displayed on the user interface when changes in control algorithm or monitored parameters change,

j) The conditions of RF energy output, or of the monitored parameters, for which the

Operator should be alerted via the user interface,

k) The messages/indications which are displayed to the operator when being alerted and the allowed responses.

I) The conditions of RF energy output, or of the monitored parameters, for which the RF output is immediately terminated,

m) The messages/indications which are displayed to the operator when delivery has been terminated.

n) The messages/indications which should be displayed to the operator when the operator manually terminates the delivery of RF output,

o) The audio tones which to be sounded by the generator during the states of operation of

RF output, alarms, and user interface events,

p) The information which is to be included in a printed or exported (e.g. as a PDF or text document) report summarizing the treatment,

q) The format of exported or printed reports.

r) The information which is to be transmitted via a network interface summarizing the treatment. For example information transmitted to an Electronic Medical Record (EMR) system.

s) The detailed information of the RF output and monitored parameters (e.g. temperature, power, impedance, heart rate as measured several times per second during a treatment) which should contained in a log file or technical database contained within the RF generator.

t) The detailed information and format in which it is to be transmitted in real time to an external device via a communications or networking interface,

u) The means by which to determine the state (i.e. condition of) the Therapeutic Device and its appropriateness for use.

v) The means by which to determine the authenticity of the therapeutic device, w) The means by which to limit the usage of the therapeutic device.

x) The detailed or summary information of the RF output, operator-adjustable parameters, monitored parameters, alerts, and end state of treatment which should be stored in an operator-accessible database within the generator. y) The detailed or summary information of the RF output, operator-adjustable parameters, monitored parameters, alerts, and end state of treatment which should be stored in the therapeutic device memory,

z) Translations to dialects, languages or regionally appropriate output of data sent to the display, peripherals or via the network interface

aa) Configuration information to control data transmission to remote locations

bb) Calibration-related information including expiration and action to take upon expiration cc) Verification instructions for ensuring the console or device is meeting minimum

performance requirements.

Parameters

00181 Optionally, the control instructions of a therapeutic device memory or secondary device memory comprise at least one parameter ('parameter').

00182 Useful parameters include any parameters used by a controller to control a system device (e.g. energy generator, therapeutic device, or secondary device). For example, a parameter can be used by an algorithm stored locally to the console or stored on the memory device of the therapeutic device or secondary device. Optionally, the algorithm can provide a step of controlling the console based on the parameter, e.g. by providing the step of controlling the console (e.g. reducing power of energy output) as a dependent variable of an independent variable defined by the parameter or value thereof (e.g. maximum temperature or impedance change). Additionally or alternatively, the parameter can define a trigger (e.g. a sensed conduction such as parameter value) that initiates a step of control (e.g. discontinuing energy output or outputting an alarm to a user output device).

00183 Optionally, the parameter is any of the following types: a target value (e.g. target power or voltage output, target temperature sensed, or target temperature range of the target site), a value limit (e.g. maximum or minimum temperature), or a value trend or pattern (e.g. trend of impedance values that indicate proper contact of electrodes to a target site).

Additionally, the parameter optionally defines an absolute value, a change in value, or a rate of change in value (e.g. temperature or impedance).

00184 Useful parameters include input (e.g. sensed or monitored) parameters, output parameters (e.g. parameters of energy output), or device parameters (e.g. verification parameters, calibration parameters, capability parameters). Optionally, the parameters comprise one or both of an input parameter (e.g. sensed parameter) and an output parameter. Optionally, the input parameter comprises a trigger and the output parameter comprises an event triggered by the trigger (e.g. trigger is change in temperature or impedance and the output parameter is the power of energy output to provide when the trigger value is sensed). Optionally, a reversibly connected memory device comprises an input parameter (e.g. target value, trigger value, or value limit), and an algorithm is provided (e.g. on console memory or on a reversibly connected memory device) that causes the system to monitor (e.g. continuously or periodically sense) the parameter (e.g. temperature, button status, or heart rate) and compare the value of the monitored parameter to the value of the input parameter stored on the memory device.

00185 Optionally, the memory device of the therapeutic device, a secondary device, or the console comprises a plurality of settings, wherein each setting comprises a set of one or more parameter values (e.g. energy output parameter values). Optionally, the system is configured such that the user can select a setting from the plurality of settings.

00186 Optionally, the control instructions comprise one or more output parameters, e.g. an energy output parameter or a U l output parameter.

00187 Optionally, the control instructions comprise one or more energy output parameters, e.g. stored on a therapeutic device memory. Useful energy output parameters include any parameters of energy output by an energy generator. Optionally, the energy generator is a generator of a therapeutic energy selected from wave, mechanical, plasma, cryoablation, and electroporation. Optionally, the therapeutic energy is wave energy selected from

electromagnetic (e.g. RF or microwave), sonic (e.g. ultrasound or H IFU), laser, or nerve stimulation.

00188 Optionally, the control instructions comprise one or more energy output parameters of electromagnetic energy, e.g. RF or microwave energy. Optionally, the one or more energy output parameters are selected from voltage, current, temperature, duty-cycle , pulse rate, pulse duration, pulse shape, ramp time, treatment time, joules delivered, frequency, waveshape, power, phase, and channel used.

00189 Optionally, the control instructions comprise one or more energy output parameters of sonic energy, e.g. ultrasound or H IFU. Optionally, the one or more energy output parameters are selected from beam intensity, beam phase, power, frequency, channels used, duty cycle, current, voltage, pulse rate, pulse duration, pulse shape, ramp time, treatment time, waveshape, phase, and joules delivered.

00190 Optionally, the control instructions comprise one or more energy output parameters of laser energy. Optionally, the one or more energy output parameters are selected from average power, peak power, beam intensity, beam size, voltage, current, duty-cycle, pulse rate, pulse duration, pulse shape, ramp time, treatment time, phase, joules delivered, and channels used.

00191 Optionally, the control instructions comprise one or more energy output parameters of nerve stimulation energy. Optionally, the one or more energy output parameters are selected from stimulation rate, waveshape, current, voltage, pulse rate, pulse duration, pulse shape, ramp time, treatment time, frequency, phase, power, channel used.

00192 Optionally, the control instructions comprise one or more energy output parameters of mechanical energy, e.g. irrigation energy. Optionally, the one or more energy output parameters are selected from flow rate, pressure, pump speed, pump torque, flow shape, ramp time, duration, and volume delivered.

00193 Optionally, the control instructions comprise one or more energy output parameters of plasma energy. Optionally, the one or more energy output parameters are selected from gas flow rate, power, voltage, initiation output level, duty cycle, pulse rate, pulse duration, pulse shape, ramp time, treatment time, joules delivered, and channels.

00194 Optionally, the control instructions comprise one or more energy output parameters of cryoablation energy. Optionally, the one or more energy output parameters are selected from coolant flow, thermoelectric power, thermoelectric current, coolant pressure, pulse frequency, pulse duty cycle, ramp rate, and treatment time.

00195 Optionally, the control instructions comprise one or more energy output parameters of electroporation energy. Optionally, the one or more energy output parameters are selected from voltage, charge, pulse rate, pulse width, joules, number of pulses, and treatment duration.

00196 Optionally, the control instructions comprise one or more U l output parameters, e.g. stored on therapeutic device memory or secondary device memory. Optionally, the one or more U l output parameters comprise notification parameters and/or display parameters.

Useful notification parameters include data displayed (e.g. screens, triggers, ranges of accepted values, or any parameter or value thereof sensed (e.g. monitored) or stored on a memory device) or alerts (e.g. warnings or alarms). Useful display parameters include text size, graph axes, update rate, filtering, color, units of values, and precision of values.

00197 Optionally, the control instructions comprise one or more capability parameters, e.g. stored on therapeutic device or secondary device memory. The capability parameter can be, e.g. any capability parameter of hardware local to the memory device (e.g. therapeutic device memory comprising a capability parameter of the therapeutic device). Useful capability parameters include compatible or incompatible modes of operation, compatible or incompatible devices (e.g. compatible or incompatible secondary devices, therapeutic devices, or consoles or energy generators).

00198 Optionally, the control instructions comprise one or more verification parameters, e.g. stored on a therapeutic device memory or secondary device (e.g. intermediate device or d/t device) memory. The verification parameters can be, e.g. parameters used by the controller to verify that the system, or connected device (e.g. therapeutic device or secondary device) thereof is properly configured or verified for use. Useful verification parameters include use data, recommend number of uses, model number, company/brand, Produced for, Production Plant, time or date of production, maximum number of uses allowed,

authentication (e.g. key) of a local device (e.g. authentication of a therapeutic device provided on therapeutic device memory), authentication of a remote device (e.g. authentication of an intermediate device provided on therapeutic device memory), re-use prevention rules, sterilization validity information, sterilization expiration date , device serial number, device authorized for use for this system , device authorized for use in the country or geography in which this system was sold, device authorized for use with this system based on systems owner, device authorized for use with this system based on system's brand name, device authorized for use with this system based on feature set, device authorized for use with this system based on the total number of treatments authorized for this system, device authorized for use with this system based on the re-use history of this device, as well as authentication key(s) of data stored on the memory device, such as a) software updates encrypted with symmetric (single key) or asymmetric (public/private) methods, the validity of which must be confirmed before the system will provide therapy, b) authorization keys encrypted with symmetric (single key) or asymmetric (public/private) methods, the validity of which must be confirmed before the system will provide therapy, or c) memory device data such as parameters encrypted with symmetric (single key) or asymmetric (public/private key) methods, the validity of which must be confirmed before the system will provide therapy.

00199 Optionally, the control instructions comprise one or more calibration parameters, e.g. stored on a therapeutic device memory or secondary device. The calibration parameters can be, e.g. any calibration parameters corresponding to hardware that is local to the memory device on which the calibration parameters are stored (e.g. calibration parameters of a therapeutic device energy delivery head stored on the therapeutic device memory). Optionally, the calibration parameters comprise structural calibration parameters and/or functional calibration parameters. Optionally, the hardware is selected from an energy delivery head, a secondary device (e.g. an intermediate device or d/t device), and a sensor (e.g. pressure sensor, contract for censor, or temperature sensor).

00200 Optionally, the control instructions comprise one or more calibration parameters of an energy delivery head. Optionally, the energy delivery head is selected from a wave energy delivery head, a mechanical energy delivery head, a plasma energy delivery head, a

cryoablation energy delivery head, and an electroporation energy delivery head, a pneumatic pressure head, a vaporizer head, or an irrigation head (e.g. irrigation catheter). Optionally, the calibration parameters are stored on a memory device local (e.g. not reversibly connected) to the hardware described by the calibration parameters.

00201 Optionally, the control instructions comprise one or more calibration parameters of a wave energy delivery head (e.g. electrode), e.g. one or more calibration parameters for energy delivery and/or one or more calibration parameters for imaging or other detection. Useful calibration parameters for energy delivery include loss factors, impedances, including for example R-L-C values, Z and Phase, complex Z and S parameters, surface area, maximum energy allowed, diameter, energy coupling factors, physical lengths (needles, tips, probes, cables), electrode exposure lengths, distance between electrodes, impedances between electrodes, impedance between channels or wiring leads, resonant frequencies, thermal impedance, thermal time constant, temperature feedback gains, offsets, and characteristic equations, and cooling flow rate. Useful calibration parameters for imaging or detection include length, area, mass, orientation, volume, opacity, and antenna coupling coefficient (e.g. of a first energy delivery head).

00202 Optionally, the control instructions comprise one or more calibration parameters of a pneumatic pressure head or vaporizer head (e.g. head ventilator or vaporizer head such as patient tube). Useful calibration parameters include tube resistance, tube diameter, tube volume, tube length, pressure vs. flow characteristic equation parameters, vaporizer output characteristic equations, leak rate, 02 Perfusion sensor characterization curves, and 02 sensor gains, offsets, and characteristic equation parameters.

00203 Optionally, the control instructions comprise one or more calibration parameters of an irrigation head (e.g. irrigation catheter). Useful calibration parameters include tube diameter, tube volume, tube length, maximum pressure allowed, maximum flow rate allowed, pressure vs. flow characteristic equation parameters, recommended flow rate, balloon volume, flow vs. cooling characteristic equation parameters, electrode size, and pressure measurement characteristic equation parameters.

00204 Optionally, the control instructions comprise one or more calibration parameters of an intermediate device. Useful calibration parameters include impedance, loss factors, frequency characterization, length, contact impedance, temperature measurement

characteristic equation parameters, pressure measurement characteristic equation parameters, and inter-signal impedances.

00205 Optionally, control instructions comprise an input parameter. Optionally, the input parameter can be parameter that is used by the controller to control (e.g. modulate, initiate, terminate, or prevent) an output such as an energy (e.g. RF) output or user output device (e.g. display such as to indicate alarms or states of a workflow). Optionally, the input parameter is a parameter of sensory input (i.e. a parameter that can be detected using a sensor), e.g. an environmental condition or a therapeutic device condition, an image parameter, a user input parameter (e.g. toggle status), or any energy output parameter that can be sensed. Optionally, the input parameter provides a target value, value limit, or value trend, e.g. that can be sensed by a sensor or monitored.

00206 Optionally, the control instructions comprise an input parameter that is an effect of treatment, for example, therapeutic effect or side effect of energy delivery. Examples of input parameters include environmental conditions such as air pressure, temperature, or chemical composition, or biological conditions such as ECG, EEG, EMG, or EOG, heart rate, respiration, oxygen saturation level, carbon dioxide saturation level, de-oxygenated hemoglobin level, blood pressure, breath rate, blood flow, and muscle contraction. Optionally, the input parameter is stored on the therapeutic device memory.

00207 Optionally, the control instructions comprise a therapeutic device condition or a secondary device condition. Examples include contact force or pressure, temperature, acceleration, impedance, phase, volume, position, disconnection, flow rate, chemical composition, rate of change of impedance, rate of change of temperature, rate of change in pressures, change in power required to maintain temperature, change in power required to maintain impedance, change in power required to maintain pressure, and change in power required to maintain flow. Optionally, the parameter is stored on the therapeutic device memory.

00208 Optionally, the control instructions comprise an image parameter, e.g. image contrast (e.g. monitored image contrast to trigger delivery of additional contrast agent), radiological marker movement, and radiological marker position. Optionally, the image parameter is stored on the therapeutic device memory. 00209

00210 Optionally, the parameter comprises state transition criteria and standards for controlling a change in user output device (e.g. display), energy output, or secondary device state.

00211 Optionally, the parameter comprises an RF output parameter. Optionally, the RF output parameter comprises one or more of voltage, current, time, temperature, stimulation rate, pulse rate, pulse duration, ramp time, frequency, amplitude, power, waveshape, power and channel used (for multi-channel configurations).

00212 Optionally, the parameter comprises an environmental condition parameter as an input parameter (e.g. trigger value, target value, or value limit). For example, the

environmental condition can be a condition of a biological tissue (e.g. target tissue) or a condition of an organism comprising target tissue. Optionally, the environmental condition is a condition affected by energy output (e.g. temperature or impedance changes due to boiling or popping of fluid at a target site). Optionally, the parameter is a diagnostic parameter.

Optionally, the parameter is any parameter that can be monitored by an optional sensor.

Optionally, the parameter defines one or more of temperature, impedance, voltage, force, pressure, fluid flow, light/optics, sound, chemical composition, thermal time constant, cross- conduction between multiple channels, image or appearance (e.g. fibre-optic imaging within balloon catheter), respiration rate, electrical activity (e.g. ECG, EEG, EMG, or EOG such as morphological feature or rate) in a tissue such as the heart, retina, cerebral cortex, or any muscle tissue, or a biological (e.g. therapeutic- or non-therapeutic-) effect of a therapeutic head of the therapeutic device.

00213 Optionally, the input parameter comprises a therapeutic device condition parameter. Optionally, the parameter defines one or more of: damage (e.g. damage of an operational head), configuration, use (e.g. duration of use, time and/or date of first or previous use, or expiration), impedance, voltage, fluid flow, thermal time constant, pressure or contract force (e.g. of RF electrode on target site), and user input status (e.g. status of a user input device of the therapeutic device such as a toggle button).

00214 Optionally, the input parameter comprises a therapeutic device condition parameter that indicates whether the therapeutic device is functioning as intended ('verification parameter'). The verification parameter is optionally any parameter that changes as a result of damage to the therapeutic device. For example, the verification parameter can indicate damage to the operational head, the connector, or operable linkages in the therapeutic device. Optionally, the verification parameter defines one or more of minimum thermistor impedance maximum thermistor impedance, minimum thermocouple impedance, maximum

thermocouple impedance, minimum RF impedance, maximum RF impedance, minimum change in temperature due to RF pulse., maximum change in temperature due to RF pulse, pressure change due to fluid injection, minimum pressure sensor impedance, and maximum pressure sensor impedance. Optionally, the memory device of the therapeutic device comprises data indicating the expected value of the verification parameter for an undamaged therapeutic device and the controller compares the actual value of the parameter (e.g. by sensor) to the expected value to determine if the therapeutic device is damaged.

00215 According to the present invention, a parameter can optionally be stored on the memory device and used by the controller to perform a therapeutic procedure (e.g. configured or modulate the energy generator and/or secondary devices such as a user interface or secondary therapeutic devices such as a fluid pump). The values of parameters stored on the memory device can be used, e.g. as triggers or dependent variables in algorithms of the controller or can be used for comparison with sensed or monitored parameter values of a sensor as well as outputted parameters of energy out.

00216 Optionally, the system comprises one or more settings (e.g. stored on a therapeutic device memory, secondary device memory, or console memory), wherein each setting comprises one or more parameters, wherein the at least one of the values of said one or more parameters are stored on a reversibly connected memory device (e.g. a therapeutic device memory or a secondary device memory). The parameters can optionally be any parameters taught herein that are stored on a memory device.

00217 Optionally, the system comprises one or more settings of energy delivery that are selectable by the controller or system user.

00218 Examples of settings for an energy delivery head include, e.g. wave energy delivery head (e.g. RF electrode), treatment temperature, treatment time, power, voltage, stim amplitude, stim rates, stim pulse width, electrodes to energize, fluid flow rate, duration of treatment, joules to deliver, size of lesion, shape of lesion, joules to absorb (cooling), maximum voltage, maximum flow rate, minimum flow rate, channels to use, type of procedure , anatomy targeted, data output formats, audible volumes. 00219 Examples of useful of settings for a pneumatic pressure head or vaporizer head include fluid flow rate, fluid volume to deliver, humidification level, pneumatic flow rate, pneumatic pressure, patient type (adult/pediatric, weight, age, gender), breath modes allowed, breath rates allowed, tidal volumes allowed, spontaneous breath intervals allowed, breath rate alarms, breath tidal volume alarms, forced-breath timeout, breath mode parameters, intra- cycle pressures (i.e. pip), inter-cycle pressures (i.e. PEEP), target oxygen perfusion, vascular support pressures, vascular support pressure gradients, and vascular compression rates.

00220 Examples of useful of settings for an irrigation head include tube diameter, volume to inject, contrast agent flow rate, pressure to maintain, maximum pressure to allow, allowable leakage rate, bubble detection sensitivity, and fluid pre-heat/cool temperature.

00221 Although the parameters taught herein are advantageously provided on therapeutic device memory or secondary device memory, the invention also contemplates embodiments in which some parameters are provided on therapeutic device memory or secondary device memory and some parameters are provided on console memory.

Executable Instructions and Algorithms

00222 Optionally, the control instructions comprise executable instructions or algorithms ('algorithms'). Useful algorithms include any algorithms that instruct the controller to control the console, a connected therapeutic device, an optional secondary device, or any I/O device (e.g. a peripheral device).

00223 Optionally, one or more algorithms are stored on the memory device of the therapeutic device or a secondary device. Alternatively, one or more algorithms are optionally stored on a console memory device, wherein the algorithms reference once or more parameters stored on the therapeutic device memory.

00224 Optionally, the control instructions comprise one or more treatment algorithms, predictive algorithms, or control algorithms.

00225 Optionally, the control instructions comprise a treatment algorithm. Useful treatment algorithms include any sequence of energy delivery events controlled by the occurrence of or change in sensed or stored parameters. The sequence can be, e.g. any sequence which has been shown to be effective at causing a therapeutic effect.

00226 Optionally, the control instructions comprise a predictive algorithm. Useful predictive algorithms include any a sequence of energy delivery events which are driven by the controller to produce a certain outcome (i.e. lesion size), based on an equation, computerized model, simulation which is calculated by the console and informed by the occurrence of or change in sensed or stored parameters.

00227 Optionally, the control instructions comprise a control algorithm. Useful control algorithms include any sequence of adjustments in the energy delivered by the console made by the controller which are calculated to maintain a sensed parameter, or multiple sensed parameters, at a predefined level or vector, based on sensory inputs. Examples useful control algorithm structures include a control law or a feedback control system, as is known in the art.

00228 Optionally, the control instructions comprise an algorithm comprising one or more of the following steps, perform a step of therapy (e.g. energy output), perform a step of sensing or monitoring (e.g. temperature or connection status), perform a step of controlling a user interface, perform a step of controlling a memory device, perform a step of controlling an imaging device, or make a calculation. Examples of useful calculations include, e.g. functions or equations referring to a parameter (e.g. as a dependent variable), e.g. as a trigger value, limit, or target value. Other useful calculations include calculation of a sensed condition based on sensor feedback (e.g. calculation of temperature based on thermocouple feedback), calculations based on a control law, for example a PID control loop, such that target values are maintained, calculations advancing the state of a computerized model of the system to predict a parameter not directly measured, calculations comparing the state of a computerized model of the system, measuring the discrepancies between the modeled and measured system, adjusting the model more accurately represent the system, and predict parameters not directly measured, and calculations which filter, integrate, or otherwise condition sensor feedback to provide a derived sensor input suitable for triggering, limit, or a target value.

00229 Optionally, a useful algorithm comprises a combination of steps selected from a) a sensing step and a therapy step (e.g. a step of therapy dependent on sensed condition); b) a sensing step and a Ul output step (e.g. sensing and displaying value or result of sensed condition), a sensing step and a step of controlling another device (e.g. a fluid flow increase triggering an ablation energy change).

00230 Optionally, a useful algorithm comprises one or more steps of controlling energy output. Optionally, the one or more steps of controlling energy output comprise one or more of enabling energy output (e.g. upon connection and verification of a therapeutic device), initiating energy output (e.g. upon sensing or detecting that parameters in an allowable region or target range, operator has selected valid settings, and operator has activated the initiation mechanism), terminating energy output (e.g. based on user input such as activating a termination mechanism, upon conclusion of an algorithm, upon a termination condition based on sensed condition, upon termination condition based on predicted outcome reached, or upon termination based on an detected fault or failure of the console, therapeutic device or other device such as a secondary device), and modulating energy output (e.g. a change in energy output based on sensed condition to maintain target value).

00231 Optionally, a useful algorithm comprises one or more steps of controlling a Ul. Examples of useful steps of controlling a Ul include displaying screens, fields, alerts, or workflows, displaying feedback from sensors or imaging device, displaying feedback from predictive models (is this already included in calculations), displaying calculations, displaying settings from which the operator must select to inform the control of the device(s), displaying device and secondary device verification information, and displaying previous data stored on a therapeutic device or secondary device.

00232 Optionally, a useful algorithm comprises one or more steps of controlling a memory device. Optionally, the steps of controlling a memory device comprise reading from (e.g. obtaining parameters or other stored data) or writing to the memory device (e.g. storing data of energy delivery record to the memory device such as storage of the sequence of some or all of sensed values, storage of initiation events, storage of termination events, or storage of energy modulation sequence).

00233 Optionally, a useful algorithm comprises one or more steps of controlling an imaging device. Examples of useful steps of controlling an imaging device include, obtaining an image, obtaining spatial and tissue characterization, performing image analysis to determine the relative position of energy delivery electrodes or head to that of anatomical structures, informing the user of adjustments to the make to the device position to achieve intended orientation of energy delivery electrodes or head and anatomical structures, controlling the injection of contrast agent to improve information of electrode and anatomical feature orientation, adjusting the orientation or position of the imaging head to improve the information of electrode and anatomical feature orientation, and adjusting the orientation or position of the patient to improve the information of electrode and anatomical feature orientation. 00234 Optionally, a useful algorithm comprises one or more steps of controlling an input device (e.g. sensor), e.g. a step of obtaining or monitoring feedback from the input device. Such steps of controlling an input device can be used, e.g. to trigger an event (e.g. any described herein), as target value, as a limit, to applying calibration parameters to obtain more accurate readings, obtaining parameters settings to achieve correct sensitivity and frequency response, or trigger the sampling of an input measurement.

00235 Optionally, a useful algorithm comprises one or more steps of making calculations. Optionally, the one or more calculations are selected from lesion calculations (e.g. lesion size, lesion shape, lesion position, amount of energy absorption by a tissue, and effect of a combination of energy from optional multiple electrodes), lung calculations (e.g. lung volume, lung compliance, lung resistance, or work of breathing), sequential compression device calculations (e.g. rate of venous bed engorgement, rate of compression sequences) , optical diagnostic device calculations (e.g. oxygen saturation, CO partial pressure, or C02 partial pressure) and surgical navigation device calculations (e.g. orientation to target, orientation to critical anatomical structures, distance to target, or distance to critical anatomical structures).

00236 Any type algorithm is useful in the present invention. For example, the algorithm can be machine code (i.e. executed directly by the controller) or can be written in any programming language (e.g. BASIC, Lua, Java, or FORTH) for which an interpreter is provided local to the controller. Optionally, the algorithm is provided as any of: a binary image directly by the console controller; dynamically linked libraries, e.g. binary images executable by the console controller, but do so by being 'called' by the software of a pre-existing higher-level application or framework; a textual representation (e.g.XML or plain-text script file), which specifies the operations to be performed to a pre-existing higher-level application or framework; a programming language; and an intermediate language which is compiled into an efficient machine-readable format which is not the native instructions of the console controller, such as p-code or Java bytecode, and is interpreted by a virtual machine pre-existing on the console.

00237 Optionally, the algorithm instructs the controller to control an energy generator, a therapeutic head of the therapeutic device, an optional sensory head of the therapeutic device, or a secondary device.

00238 Optionally, the algorithm comprises one or more parameter values. The one or more parameters are optionally any parameters taught herein. In this embodiment, the algorithm can be provided on the memory device of the therapeutic device. Alternatively, the algorithm references one or more parameters, the values of which are not provided by the algorithm. In this alternative embodiment, optionally a) the algorithm and the parameter values can both be stored on the memory device of the therapeutic device; or b) the algorithm can be stored locally to the controller and the parameter values can be stored on the memory device of the therapeutic device.

00239 Optionally, the algorithm is configured for controlling one or more output devices based on the input from one or more input devices. For example, the algorithm can comprise a step of controlling an output device (e.g. energy generator such as RF generator or fluid pump or a user output device such as a Ul) that is dependent or triggered by the input from a sensor (e.g. temperature sensor, ECG, or impedance sensor).

00240 Optionally, the algorithm comprises one or more steps of initiation, termination, prevention (e.g. prevention of output), or modulation (e.g. modulation of output). Optionally, the steps are triggered steps, e.g. the algorithm comprises (or references) parameter values that must be present prior to the controller carrying out a step (e.g. a trigger that automatically results in carrying out of the step or a trigger that allows the carrying out of a step).

00241 Optionally, the algorithm comprises instructions for conducting an RF procedure ('RF algorithm').

00242 Optionally, the algorithm is an RF algorithm comprising or referencing one or more parameters taught herein. Optionally, the algorithm provides one or more of: channel(s) to control; average power to deliver; peak power to deliver; duration of delivery; temperature to maintain; voltage to maintain; current to maintain; maximum power to be used to maintain voltage; maximum power to be used to maintain current; maximum power to be used to maintain temperature; minimum power to be used to maintain temperature; maximum number of joules to deliver; maximum voltage allowed; maximum current allowed; time to ramp to temperature; time to ramp to power; profile, or intermediate points on power vs. time curve, to be followed while changing power; profile, or intermediate points on temperature vs. time curve, to be followed while changing temperature; modulation period of RF energy; modulation duty cycle of RF energy; frequency of RF energy; control systems gains (e.g.

proportional, integral, and/or derivative gains in temperature and power PID control loops); estimates of parameters used to predict the response of the patient/device system such as thermal mass, thermal time constant, or energy lost to blood flow, etc. Optionally, the algorithm provides one or more triggers. 00243 Optionally, the algorithm (e.g. RF algorithm) comprises one or more triggers. The triggers can be any parameters or parameter values that that cause the controller to perform a step or a series of steps ('segment' or 'states') in a workflow such as a sensory step, an output step (e.g. RF output), or a step of setting one or more other triggers. Optionally, the one or more triggers are selected from: absolute maximum temperature limit, absolute minimum temperature limit; a bsolute maximum power limit; absolute minimum power limit; absolute maximum impedance limit; absolute minimum impedance limit; relative temperature change; relative power change; relative impedance change; expiration of time; rate of change of temperature; rate of change of impedance; rate of change of power ; activation of an RF power activation switch; activation of an RF power activation footswitch; activation of an RF power activation hand switch; ECG feature; ECG rhythm; ECG rate; respiration rate; change in thermal time constant; and change in losses due to blood flow.

00244 Optionally, the algorithm (e.g. RF algorithm) comprises one or more parameters or parameter values that allow or prevent initiation of a therapeutic procedure. Optionally, the parameters include one or more of: target RF impedance (e.g. max or min); target therapeutic device temperature (e.g. max or min); use status of the therapeutic device (e.g. used or unused status); duration of the previous use of the therapeutic device; authentication of therapeutic device; damage status of the therapeutic device; expiration status; detection or non-detection of pulsatile flow; contact force (e.g. max or min); ECG rhythm; ECG feature detection operating; irrigation flow e.g. of an aspiration or infusion device (e.g. max or min); irrigation pressure, e.g. of an aspiration or infusion device (e.g. max or min); and inflation pressure e.g. of an expandable device (e.g. max or min).

Software

00245 A console useful in the invention optionally comprises a memory device ('console memory') comprising system software configured to control the console.

00246 The system software can, for example, provide a framework for controlling devices, running algorithms, and parsing parameters from reversibly connected memory devices (e.g. therapeutic device memory or secondary device memory). Optionally, the framework comprises a programing language. Optionally, the programing language comprises any of the following: scripted language (i.e. Lua, Forth) sequences languages for defining treatment algorithms, control algorithms, or predictive algorithms; compiled objects or dynamic-link- libraries containing embedded implementations of Treatment, Control, or Predictive algorithms; scripted language (i.e. Lua, Forth) sequences for customized reports; scripted language sequences for customized user interfaces; or scripted language sequences for customized electronic communications such as custom databases, email, hospital information systems (H IS), laboratory information systems (LIS), or standardized health information reporting i.e. health Level Seven International (HL7).

00247 Optionally, the system software comprises a configuration management function. Optionally, the configuration management function is configured for conflict resolution and/or to obtain rules from a memory device (e.g. a reversibly connected memory device such as therapeutic device memory or secondary device memory).

00248 Optionally, system software obtains clinical rules or business rules from a memory device. Optionally, the business rules are any rules which prescribe how conflicts of device and software appropriateness should be resolved (e.g. If a memory device has software older than what is already installed, should the software be 'downgraded' before use; or when at least one of the devices in the system has passed its expiration date, should the user be able to override). Optionally, the clinical rules are any rules that prescribe how conflicts of treatment algorithms should be resolved (e.g. one device in the system contains information that a flow rate of 20ml/min should be used, but another contains information that 25ml/min should be used. Should one device overrule the other based on type or age? Should the operator be queried to resolve?). Examples of useful rules include identification of compatible device combinations, identification of compatible software, instructions for selecting a software version, instructions to downgrade or upgrade software, an override rule, an error-possessing rule, a data-write rule, or a display rule.

00249 Optionally, the system software is configured to obtain a software update from a reversibly connected memory device (e.g. therapeutic device memory or secondary device memory).

00250 Optionally, the system software comprises executable Instructions and algorithms, e.g. any described in the Executable Instructions and Algorithms section above. For example, the system software can comprise treatment algorithms, control algorithms, predictive algorithms, and/or any algorithm, e.g. that references one or more parameters or algorithms stored on a reversibly connected memory device (e.g. therapeutic device memory or secondary device memory). 00251 Optionally, the system software comprises one or more specifications. Device specifications can be any target or accepta ble values of parameters (e.g. verification parameters, capabilities, or calibration parameters), e.g. stored as data on a console, that are used for comparison with the actual parameter values stored on a reversibly attached device. Optionally, the system is configured to prevent treatment if the device specifications listed on the console memory do not match the respective parameter values listed on the therapeutic device memory or an optional secondary device memory.

00252 Optionally, the console comprises a console memory device comprising one or more calibration parameters or capabilities parameters of an internal or local device ('internal parameters') such as an energy generator. Such internal parameters such as internal calibration parameters can be used by the controller, e.g. to determine how to achieve a given output using the internal device (e.g. energy generator) or how to interpret a given input from a sensor.

Secondary Device

00253 In one embodiment, a system of the invention comprises a first console comprising a first energy generator and a reversibly connected first therapeutic device comprising a first memory device and a first operational head having a first energy delivery head configured for transmitting the energy output of the first energy generator ('first energy output') and the system further comprises at least one additional electronic device comprising an I/O device that provides a second function other than transmitting the first energy output to the first energy delivery head ('secondary device'). Optionally, the instructions for controlling the secondary device are provided on a reversibly linked memory device (e.g. the first memory device or an optional memory device of the secondary device). Examples of useful systems comprising a secondary device are detailed in Example 13 through Example 19.

00254 The secondary device can be operably linked to a system controller in any manner. The secondary device can be, e.g. provided by the therapeutic device, the operational head thereof (e.g. a sensor in a catheter tip or a sensor of a therapeutic device as depicted in Figure 7), or operably linked to the console controller separately (e.g. a fluid pump connected to the console through a different connector than the therapeutic device, e.g. as depicted in Figure 8).

00255 Optionally, the secondary device comprises any d/t device or other I/O device configured to operate in cooperation with the energy delivery head, for example, to conduct a therapeutic procedure such as ablation. Examples of such systems are detailed in Example 13 through Example 19.

00256 Useful secondary devices include any d/t device. Optionally the d/t device is a sensor or a device providing a therapeutic function.

00257 Optionally, the secondary device is any of: a. a sensor or other d/t device provided by the therapeutic device, or operational head thereof (e.g. the sensor depicted in Figure 7 or Figure 9); b. a second therapeutic device is reversibly connected to the console (e.g. by an independent reversible connector, e.g. as depicted in Figure 8), optionally comprising reversibly linked memory (e.g. as depicted in Figure 8); c. a secondary device comprising a console (i.e. a second console) with a communications link to the first console (e.g. as depicted in Figure 9); d. a d/t device reversibly connected to the console (e.g. the sensor depicted in Figure 7 or Figure 8, the sensor or second therapeutic device depicted in Figure 9, )or non-reversibly connected to the console (e.g. embedded in) the console; or e. an intermediate device positioned between reversibly connected to both the console and the therapeutic device (e.g. to provide a serially connected chain of devices), e.g. as depicted in Figure 11.

Examplary Systems with a Secondary Device

00258 In one embodiment, the invention provides a system comprising: a. a first console comprising a first energy generator and a first controller

configured for controlling the energy output of the first energy generator ('first energy output'), optionally wherein the first energy output comprises therapeutic energy; b. a first therapeutic device comprising:

I. an operational head comprising a first energy delivery head configured for transmitting the first energy output to a target site; and II. a first memory device comprising control instructions for said controlling the first energy output;

c. a first reversible connector configured for operably linking the first energy generator to the first energy delivery head;

d. a first reversible memory operable linkage configured for operably linking the first memory device to the first controller; and

e. an electronic device comprising an input or output device ('I/O device)

configured for providing a function other than said transmitting the first energy output to the target site ('secondary device'), wherein:

i. the secondary device is operably linked to the first controller; and ii. optionally, the system comprises control instructions for controlling the secondary device on a memory device that is reversibly linked to the first controller.

00259 Examples of such an embodiment are provided by Example 13 through Example 19.

00260 Optionally, the first energy generator is a first therapeutic energy generator.

Optionally, the first therapeutic energy generator is a generator of energy selected from electromagnetic energy (e.g. RF energy, microwave energy, and laser energy), mechanical energy (e.g. sonic energy, irrigation or fluid pump, or pneumatic pressure), thermal energy (e.g. heat a blation), freezing energy (e.g. cryosurgery energy) and electrical energy (e.g.

electrocautery energy, electrosurgery energy, or electroporation energy). Optionally, the first therapeutic energy generator is a generator of energy selected from ablation energy, cutting energy, and thermal energy. Optionally, the first therapeutic energy generator is a generator of energy selected from RF energy, sonic (e.g. ultrasound) energy, microwave energy, laser energy, cryoablation energy, plasma energy, electroporation energy, and high intensity focused ultrasound (HIFU) energy.

00261 Optionally, the first memory device comprises the control instructions for controlling the secondary device. Additionally or alternatively, the secondary device optionally comprises a second memory device comprising control instructions for controlling the secondary device, optionally wherein the second memory device is reversibly linked to the first controller.

00262 Optionally, the secondary device comprises any I/O device that transmits (i.e. sends and/or receives) data or analog signals to or from a controller. Optionally said controller is the first controller (e.g. controller 1/pressure sensor depicted in Figure 9) or a second controller in communication with the first controller (e.g. controller 2/vaporizer depicted in Figure 9). Optionally, the I/O device is reversibly linked to the first controller (e.g. by a second reversible connector), e.g. the sensor depicted in Figure 7, the fluid pump or sensor depicted in Figure 8, the pressure sensor depicted in Figure 9, or the vaporizer depicted in Figure 9 when the communications link comprises a reversible communications link . Optionally, the I/O device is reversibly linked or non-reversibly lined to a second controller (e.g. the vaporizer depicted in Figure 9, or the imaging device depicted in Figure 10), wherein the second controller is reversibly linked to the first controller (e.g. by a reversible data link connector such as an Ethernet cable).

00263 Optionally, the secondary device comprises a second memory device (e.g. memory device 2 of Figure 8, Figure 9, or Figure 11). Optionally, the second memory device comprises instructions for controlling the secondary device, instructions for controlling the therapeutic device, instructions for controlling the first console, or instructions for controlling an optional second console to which the secondary device is opera bly linked.

00264 Optionally, the secondary device comprises an I/O device that provides a therapeutic or diagnostic function fd/t device').

00265 Optionally, the secondary device comprises an I/O device selected from a second energy generator, a user interface ('Ul'), and an intermediate device.

00266 Optionally, the secondary device comprises a second energy generator, wherein the second energy generator is a generator of a diagnostic energy or a therapeutic energy.

Optionally, the secondary device comprises a second controller configured to control the second energy generator, e.g. provided together in a second console. Optionally, the second energy generator is reversibly linked to a second operational head configured for transmitting the output of the second energy generator to a target tissue (e.g. the same or different target tissue as the output of the first energy generator) e.g. as depicted in Figure 9. Optionally, the secondary device is reversibly linked to the first console (e.g. the irrigation device depicted in Figure 8). Optionally, the secondary device comprises a second memory device that is reversibly linked to the first console (e.g. the second memory device depicted in Figure 8 or Figure 9, noting that the second memory device in Figure 9 is indirectly linked to the first console through the second console). 00267 Optionally, the second energy generator is a generator of therapeutic energy.

Optionally, the second energy generator is a generator of therapeutic energy selected from electromagnetic energy (e.g. RF energy, microwave energy, and laser energy), mechanical energy (e.g. sonic energy, irrigation or fluid pump, or pneumatic pressure), thermal energy (e.g. heat a blation), freezing energy (e.g. cryosurgery energy) and electrical energy (e.g.

electrocautery energy, electrosurgery energy, or electroporation energy). Optionally, the second energy generator is a generator of therapeutic energy selected from ablation energy, cutting energy, and thermal energy. Optionally, the second energy generator is a generator of therapeutic energy selected from RF energy, sonic (e.g. ultrasound) energy, microwave energy, laser energy, cryoablation energy, plasma energy, electroporation energy, and high intensity focused ultrasound (HIFU) energy.

00268 Optionally, the second energy generator is a generator of diagnostic energy.

Optionally, the diagnostic energy is imaging energy such as electromagnetic imaging energy (e.g. RF imaging energy or X-ray imaging energy), magnetic energy (e.g. as In magnetic resonance imaging ('MRI'). or sonic energy (e.g. as in ultrasound imaging).

00269 Optionally, the secondary device comprises a Ul. Optionally, the Ul comprises a display, a speaker, or both. Optionally, instructions for controlling the secondary device comprise instructions to provide the user with feedback, optionally wherein the feedback is selected from: feedback from a temperature sensor or other sensor, connection status of the therapeutic device to the first console, authenticity of the therapeutic device, and use data of the therapeutic device. Optionally, the instructions for controlling the secondary device comprise labels, screens, fields, or workflows to be displayed or otherwise presented to a user. Optionally, instructions for controlling the Ul are provided on the first memory device.

00270 Optionally, the secondary device is an intermediate device (e.g. as depicted in Figure 11). According to the present invention an intermediate device is any device comprising an a member configured to transmit energy output between a generator and an energy delivery head ('extension'), wherein the device comprises at least two connectors opera bly linked to the extension, wherein one of said connectors is configured for coupling to the console (or a serially linked intermediate device of a chain of two or more intermediate mediate devices between the console and the therapeutic device). and the other of said connectors is configured for coupling to the therapeutic device (or a serially linked intermediate device). Optionally, the intermediate device comprises a memory device. Optionally, the memory device of the intermediate device comprises instructions for controlling the console (or energy generator thereof). For example, the instructions can comprise algorithms that are useful with the intermediate device or parameters of the intermediate device. Examples of useful parameters of the intermediate device include calibration parameters (e.g. impedance, loss factors, or frequency characterization), capability parameters (e.g. compatible or incompatible modes of operation, compatible or incompatible therapeutic devices; compatible or incompatible consoles or energy generators), and verification parameters (e.g. use data of the intermediate device, recommend number of uses of the intermediate device, authentication of the intermediate device, re-use prevention rules of the intermediate device, or sterilization validity information of the intermediate device). Optionally, the extension has a length greater than any of 30 cm, 60 cm, 90 cm, 120 cm, 150 cm, 300 cm, 500 cm, 1 m, or 2 m.

00271 Optionally, the secondary device comprises a d/t device. Optionally, the d/t device is a diagnostic device selected from a sensor (e.g. as depicted in Figure 7) and an imaging device (e.g. as depicted in Figure 8). Alternatively, the d/t is an I/O device that provides a therapeutic function (e.g. the fluid pump depicted in Figure 8 or the vaporizer depicted in Figure 9).

00272 Optionally, the secondary device comprises one or more sensors selected from a temperature sensor, a force sensor, an air pressure sensor, a heart rate sensor, an ECG sensor, an EEG sensor, an EMG sensor, an EOG sensor, and a respiration sensor. Optionally, the secondary device comprises an imaging device. Optionally, the secondary device comprises an imaging device and the first energy generator is a generator of therapeutic energy such as heating, freezing, cutting, or ablation energy (e.g. RF energy, sonic energy, microwave energy, and laser energy, cryoablation energy, plasma energy, electroporation energy, or high intensity focused ultrasound (HIFU) energy). Optionally, the imaging device is configured or used for imaging the energy delivery head of the first therapeutic device.

00273 Optionally, the secondary device comprises an imaging device and the first energy generator is a generator of therapeutic energy such as heating, freezing, cutting, or ablation energy, and the first memory device comprises parameters of the first energy delivery head (e.g. parameters of an ablation electrode or tissue-contacting component) that can be correlated with feedback from the imaging device (e.g. length, area, mass, orientation, volume, opacity, or antenna coupling coefficient of the first energy delivery head). Optionally, the imaging device is configured or used for imaging the energy delivery head of the first therapeutic device. For example, the system can be configured to perform a method (e.g. via an algorithm provided on the memory device of the first therapeutic device, a memory device of the secondary device, or a console memory device) or a memory device of the first console) comprising the steps of a) obtaining the parameters of the first energy delivery head, b) obtaining imaging feedback from imaging device; and c) correlating or modifying the imaging feedback based on one or more of said parameters of the first energy delivery head, and optionally presenting said feedback on a display, and optionally wherein said feedback or presentation on a display comprises a lesion calculation, e.g. a calculation selected from lesion size, lesion shape, lesion position, amount of energy absorption by a tissue, and effect of a combination of energy from optional multiple electrodes.

00274 Optionally, the secondary device comprises an imaging device and the first energy generator is a generator of therapeutic energy such as heating, freezing, cutting, or ablation energy, and the system is configured for transmitting feedback from the imaging device to the first controller (e.g. via an algorithm provided on the memory device of the first therapeutic device, a memory device of the secondary device, or a console memory device). Optionally, the imaging device is configured or used for imaging the energy delivery head of the first therapeutic device. Optionally, the imaging feedback transmitted from the imaging device to the first controller comprises spatial or tissue characterization information. Optionally, the first controller is configured to modulate the energy output or select or modify algorithms for energy output (e.g. via an algorithm provided on the memory device of the first therapeutic device, a memory device of the secondary device, or a console memory device) based on the transmitted imaging feedback.

00275 Optionally, the secondary device comprises an imaging device and the first energy generator is a generator of therapeutic energy such as heating, freezing, compression, cutting, or ablation energy, wherein the first controller is configured for obtaining the parameters of the first energy delivery head and modifying or selecting treatment algorithms stored on the first memory device or a console memory device based on the obtained parameters.

00276 Optionally, the secondary device comprises an imaging device and the first energy generator is a generator of therapeutic energy such as heating, freezing, compression, cutting, or ablation energy, wherein the first memory device comprises parameters of the first energy delivery head. Optionally, the parameters of the first energy delivery head are selected from length, area, mass, orientation, volume, opacity, antenna coupling coefficient. Optionally the parameters of the first energy delivery head are selected from size, distance, surface area, impedance, calibration and correction factors, coupling factors, frequency-specific

characterizations, resonant frequency, and opacity.

00277 Optionally, the first energy output is a therapeutic energy and the secondary device comprises a sensor of an effect (e.g. biological effect or environmental effect) of the therapeutic energy. For example, the therapeutic energy can be ablation or heating energy (e.g. RF energy, sonic energy, microwave energy, and laser energy, cryoablation energy, plasma energy, electroporation energy, and high intensity focused ultrasound (H IFU) energy) and the effect can be any of temperature, a heart rate, an ECG, an EEG, an EMG, an EOG, and a respiration rate. Optionally, the first memory device comprises instructions for obtaining feedback (e.g. digital or analog feedback) from the sensor and controlling the first energy output based on the obtained feedback (e.g. terminating or down-modulating energy feedback if temperature exceeds a temperature limit). Optionally, the first memory device comprises at least one target parameter of the sensor feedback (e.g. acceptable range of sensor readings, limits of sensor readings), optionally wherein said target parameter is a trigger for one or more control instructions of the first energy generator (e.g. initiation, termination, or modulation of energy output).

00278 Optionally, the secondary device comprises a d/t device that provides a therapeutic function. Such a d/t device can be any I/O device that provides a therapeutic function.

Optionally, the d/t device comprises a therapeutic I/O device selected from a fluid pump, a vaporizer, a ventilator, or any other therapeutic energy generator.

00279 Optionally, the secondary device comprises a fluid pump reversibly linked to the first controller (e.g. by a second reversible connector). Optionally, the fluid pump is reversibly linked to a second energy delivery head (e.g. cannula such as a cannula of an irrigated ablation catheter), for example by a third reversible connector. Optionally, the secondary device comprises a second memory device comprising instructions for controlling the fluid pump (e.g. fluid pump parameters, or algorithms for controlling the fluid pump, e.g. based on temperature or other sensed or calculated parameters such as image contrast (e.g. the amount of contrast agent or the need for more or less imaging contrast agent irrigated by the fluid pump).

Optionally, the first memory device comprises instructions for controlling the fluid pump (e.g. algorithms such for controlling the fluid pump, e.g. based on temperature or other sensed or calculated parameters). Optionally, the first memory device comprises an algorithm for controlling the fluid pump (e.g. a set of instructions comprising one or more steps of pumping fluid, e.g. based on a sensed parameter such as temperature or a calculated parameter) and the second memory device comprises parameters of the fluid pump (e.g. calibration parameters used by the first controller to operate the fluid pump according to the algorithm). Optionally, the fluid pump is further linked to a reservoir (e.g. for holding coolant, a contrast agent, or any fluid) such that fluid can be transmitted between the reservoir and the second energy delivery head.

00280 Optionally, the secondary device comprises a second energy generator and a second energy delivery head reversibly linked thereto (e.g. as depicted in Figure 9). Optionally, the secondary device comprises a second memory device (e.g. comprising instructions for controlling the secondary device). Optionally, the secondary device comprises a therapeutic device comprising the second energy delivery head and a second memory device (e.g. as depicted in Figure 9). Optionally, the second memory device is reversibly linked to the first controller (e.g. as depicted in Figure 9). Optionally, the secondary device comprises a second controller configured for control of the second energy generator and the second memory device is reversibly linked to the second controller (e.g. as depicted in Figure 9). Optionally, the second energy delivery head is reversibly connected to the first controller, for example, by a reversible connecter positioned between the second energy delivery head and the first controller; or by a reversible connecter positioned between the first controller and a second controller, wherein the second energy delivery head is reversibly or non-reversibly linked to the second controller and/or a second energy generator controlled by the second controller.

00281 Optionally, the secondary device comprises 1) a second console comprising a second energy generator and a second controller; and 2) a second therapeutic device comprises a second memory device and a second energy delivery head, wherein the second energy delivery head and the second memory device are reversibly linked to the second console (e.g. by reversible energy delivery linkage and reversibly memory linkage, respectively), and wherein the first console is reversibly or non-reversibly linked to the second console (e.g. a data link connecting the first controller and second controller), for example as depicted in Figure 9. For example, in addition to the first console and first therapeutic device, the system comprises a secondary device, wherein: a. a secondary device comprises: i. a second console comprising a second energy generator and a second controller configured for controlling the energy output of the second energy generator ('second energy output');

ii. a second therapeutic device comprising:

a) a second energy delivery head configured for transmitting the second energy output to a target site; and

b) a second memory device comprising control instructions for said controlling the second energy output;

iii. a second reversible connector configured for operably linking the second energy generator to the second energy delivery head; and

iv. a second reversible memory operable linkage configured for operably linking the second memory device to the second controller; and b. the system comprises a data link connecting the first controller and the second controller.

00282 In any system comprising a plurality of generators such as a first energy generator and a second energy generator, the two energy generators can be any combination of energy generators. Optionally, the two energy generators are any two energy generators that provide simultaneous or other coordinated therapy and/or diagnostic function. Optionally, the system is configured or used for targeting the energy output of the two energy generators to the same target site. Optionally, the first and second energy generators can be a therapeutic energy generator and an imaging energy generator. As another example, the first and second energy generators can each be therapeutic energy generators (e.g. a first and second a blation or heat energy generators). Optionally, the first and second energy generators are any combination listed in Table 1.

Table 1 Energy Generator Combinations

Figure imgf000056_0001

00283 Optionally, the secondary device comprises a second energy delivery head. In such an embodiment, the first energy delivery head and the second energy delivery head are optionally comingled together and/or configured to transmit the respective energies to the same target site. Examples of a shared target site include a body cavity, a body lumen, and an organ. Examples of comingled energy delivery heads include a) a catheter, or other operational device, comprising an energy delivery electrode as a first energy delivery head (e.g. for transmitting ablation energy to a target site) and a cannula as a second energy delivery head (e.g. a cannula configured for irrigating fluid to and/or from the target site, e.g. an open or closed loop irrigation catheter); b) a patient tube circuit or facemask as a first energy delivery head (e.g. for transmitting pneumatic energy from a ventilator) and, as the second energy delivery head, an inlet (e.g. port for introduction of gas or vapor) to the patient tube circuit or facemask. Similarly, a sensory head (e.g. a temperature sensor or contact force sensor) of a secondary device can also be comingled with the first energy delivery head and/or configured sense an environmental or biological effect at the target site, for example, a catheter comprising energy delivery electrodes and one or more sensors.

Configuration Management Software

00284 Optionally, a system of the invention comprises configuration management software. According to the present invention, 'configuration management software' is any software configured to obtain data from two or more of memory devices of the system, and provide a set of control instructions for a therapeutic procedure using less than all of said data. At least one of said memory devices is a reversibly connected memory device (e.g. memory device of a reversibly connected therapeutic device or secondary device). Optionally, at least two of the two or more memory devices are reversibly connected memory devices. An example of a system comprising configuration management software is detailed in Example 19

00285 Optionally, the configuration management software is provided on a memory device local to the console. Alternatively, the configuration management software can be provided on the memory device of a reversibly connected therapeutic device or secondary device and uploaded or run on the console controller.

00286 Optionally, the set of control instructions for a therapeutic procedure comprises an algorithm (e.g. a treatment algorithm), one or more parameters, or a controller software update.

00287 Optionally, the configuration management software configured for interpreting and/or implementing, said data. 00288 Optionally, the data comprises a set of control instructions from each of the two or more of memory devices.

00289 Optionally, the configuration management software is configured for conflict resolution between two sets of control instructions. Optionally the conflict resolution comprises identifying an inconsistent or incoherent combination of the at least two sets of control instructions and providing a set of control instructions for a therapeutic procedure, for example, by selecting a set of control instructions from the two sets of control instructions or selecting portions from the two sets of control instructions. Optionally, the inconsistent or incoherent combination of control instructions are inconsistent or incoherent combination of parameters (e.g. different target values of a parameter such as when a first set of control instructions comprise a target temperature that is different from a target temperature provided by a second set of control instructions). Optionally, the inconsistent or incoherent combination of the at least two sets of control instructions comprises any of: a. control instructions provided on two respective memory devices, each containing a software update for one or more consoles which are different from the other;

b. control instructions provided on two respective two memory devices, each containing settings or algorithms which are different from the other;

c. first control instructions provided on a reversibly connected memory device which contain settings for a device, and a console memory device which also contains second control instructions comprising settings for said device which are different than the settings of the first control instructions;

d. first control instructions provided on a reversibly connected memory device contains a first software version for the console, and a console memory device which contains a second software version for the console, wherein the second software version is a more recent version than the first software version;

e. control instructions provided on a reversibly connected memory device comprising a first software version for the console, and control instructions provided on another memory device which comprise a second software version for the console, wherein the first software version is different than the second software version; f. control instructions provided on a reversibly connected memory device which specify use with an compatible connected device or console, wherein the system comprises a connected device or console other than said an compatible connected device or console;

g. control instructions provided on a memory device that contains a list of one or more compatible therapeutic devices, sensory devices, or console, wherein said system includes a therapeutic device, sensory device, or console that is not provided in the list;

h. control instructions provided on a memory device that contains a list of one or more incompatible therapeutic devices, sensory devices, or console, wherein said system includes a therapeutic device, sensory device, or console that is provided in the list;

i. control instructions provided by respective memory devices that comprise non- redundant control instructions or parameter.

j. control instructions provided by respective memory devices, wherein at least one of the sets of control instructions comprises less than a full set of instructions required to perform a therapeutic procedure

k. control instructions provided by respective memory devices, wherein at least one of the control instructions reference a console, therapeutic device, or secondary device which is not connected to the system.

00290 Optionally, the configuration management software is configured for obtaining data (e.g. software, parameters, or algorithms) from the at least two memory devices determining the most-appropriate combination of data to use for a therapeutic procedure.

00291 Optionally, the configuration management software is configured to obtain one or more business rules or clinical rules from at least one memory device. Optionally, the one or more business rules or clinical rules are selected from: a. an identification of combinations of other devices are compatible with a

particular device;

b. an identification of which software is compatible with device combinations; c. instructions for selecting a software version from one of the memory devices d. instructions to downgrade console software or to utilize newer software

provided by a reversibly connected memory device when a console's memory device contains more-recent software or information than that specified by any currently connected reversibly connected memory device;

e. an override rule, optionally wherein said override rules an override configured to run when instructions on a reversibly connected memory device indicate that its respective therapeutic device or secondary device has use limits, optionally wherein the override rule specifies whether treatment can proceed if a device has met or exceeded its use or re-use limit

f. an error-processing rule, optionally wherein the error-processing rule specifies if treatment can initiate when memory is not present in a reversibly connected device, or the memory cannot be read;

g. a data-write rule, optionally wherein the data-write rule specifies which memory device, should be written with data or feedback from the current therapeutic procedure and

h. a display rule, optionally wherein the display rule specifies the information that is displayed to the user for a given combination of devices.

00292 Optionally the configuration management software is configured for ranking two or more memory devices, or control instructions provided thereby, and selecting data associated with a higher ranking. Optionally, ranking is based on any of: software version or date, device capabilities, region or geographic region, and user selection.

Other Optional Configurations

Isolation Barrier

00293 A system of the present invention optionally comprises an alternating current (AC) user interface (e.g. display) and/or other high voltage device in the console, wherein the memory of the therapeutic device comprises an electrical linkage (e.g. memory wires) to the console or high voltage device thereof, and the system further comprises an isolation barrier between high voltage device and the energy (e.g. RF) output operable linkage.

00294 The mechanics of placing a memory device within a patient-applied therapeutic device can sometimes produce s electrical safety concerns. Frequently RF Generators are powered via AC Outlets or otherwise connected to other equipment which does so. The patient can optionally be protected from such voltages. For example, the memory wires can ultimately be connected to the U l system because that system optionally requires a large part of the data which could be stored on the memory, and is optionally at the 'top' of the computing/control hierarchy. The Ul may not, however, provide enough isolation from AC to be connected to a patient. Thus, the memory wires can optionally be positioned an effective distance away from the patient applied energy output operable linkage (i.e. using a large connector providing an insulation barrier), as depicted in Figure 4a, or an additional level of isolation is optionally provided. This additional level of isolation optionally comprises an electronic isolation barrier, e.g. as depicted in Figure 4b, such as opto-isolators, transformers, MEMS-based electromagnetic couplers, or a combination thereof.

Methods

00295 A system of the present invention can be used in any therapeutic procedure.

00296 Optionally, the therapeutic procedure is an RF procedure. The RF procedure can be any procedure that utilizes RF energy to provide a therapeutic effect.

00297 Optionally, the therapeutic procedure is a heating procedure such as RF heating or other heating energy. Optionally, the heating procedure is an ablation procedure, a cutting procedure, a coagulation procedure, an occlusion procedure, or a procedure that induces or modulates metabolic processes in a target tissue.

00298 Optionally, the therapeutic procedure is an RF procedure selected from: vision correction (e.g. to reshape a cornea), tumor ablation, sleep apnea treatment (e.g. use of RF energy to reduce volume of tongue), snoring treatment (e.g. RF energy delivered by a thin probe through the lining of the palate into the deeper tissues, creating a lesion that reduces the volume of soft tissue and elevates the palate), cosmetic surgery (e.g. RF energy delivered for the treatment of skin in dermatology and plastic surgery applications, e.g. to tighten and/or conform skin by thermal restructuring of the dermal collagen matrix with stiffening), reduction of an enlarged prostate, treatment for rapid heartbeat syndrome, tightening loose joints, treatment of varicose veins, treatment of back pain, treatment of incontinence, a pain management procedure, a cardiac procedure (e.g. to destroy abnormal electrical pathways contributing to cardiac arrhythmia), a tumor reduction or removal procedure, and a dermatology procedure such as skin resurfacing.

00299 Optionally, the RF procedure is an RF ablation procedure. The RF ablation procedure can be any procedure that kills cells by application of RF energy. Optionally, the procedure is a nerve ablation procedure or a tumor ablation procedure (e.g. Lung, kidney, breast, rectal, colon, bladder, esophageal, brain, pancreatic, skin, cervical, ovarian, prostate, stomach, lymphatic, bone or liver tumor). Optionally, the procedure ablates an electrical pathway that enables an undesirable condition (e.g. atrial fibrillation).

00300 Optionally, the RF procedure is a nerve ablation procedure. Optionally, the nerve ablation procedure is used to treat pain, e.g. by destroying the ability of a nerve to transmit pain signals. Optionally, the nerve is a nerve surrounding the facet joints on either side of the lumbar spine. Optionally, the procedure comprises ablating sympathetic nerves to affect a change in physiologic parameter (e.g. renal nerve ablation).

00301 Optionally, the RF procedure comprises delivering RF energy to a target tissue selected from: brain, elbow, eyes, heart, kidney, knee, liver, nose, ovary, prostate, spine, and tongue.

00302 Optionally, the RF procedure comprises delivering RF energy to impart any of:

ablation, rhizotomy, coagulation cauterization, and lesioning at a target site.

00303 Systems of the present invention can be configured to perform any of the therapeutic procedures taught herein. For example, the controller, RF generator, and therapeutic device can be specifically configured to perform any of the therapeutic procedures. With the teachings provided herein, one skilled in the art can readily provide such

configurations.

00304

Superior Properties

00305 Systems of the present invention provide one or more superior properties. For example, the system can have any of the following properties:

• no longer require salespeople, biotechs or other personnel to carry a software upgrade to the RFG;

• no longer are forced to develop, build and certify an entirely new software release for each new catheter or device - the necessary incremental additions come with the catheter. This means a significant reduction in cost for medical device equipment manufacturers for building and releasing new software releases for each new treatment.

• A major reduction in time-to-market for new treatments • no longer require a separate RFG for each new clinical treatment (i.e. a pain generator, an asthma treatment generator, a renal denervation generator, a facial nerve (glabella furrowing) generator, etc. One generator does all of these treatments with the specific control software and user interface software stored in the catheter. The generator could be wheeled from the interventional radiology suite over to the neurosurgery suite with no modification other than plugging in the appropriate catheter for the

appropriate procedure.

• A drastic reduction in capital equipment costs for the hospitals since the same RFG can be used for multiple different procedures where it current requires a different RFG for each procedure.

• A drastic reduction in the cost of sustaining, maintaining and servicing RFGs in hospitals and doctors' offices.

• A new capability for removing the connector portion of the catheter and sending it back to the manufacturer as a part of a verification and maintenance program.

• An increase in the amount of reuse of design elements, documentation, and testing in new applications, increasing the reliability of new applications, and reducing the regulatory burden of bringing new applications to market.

• A new capability to determine whether an energy generator such as an RF generator ('RFG') may contain a latent defect introduced inadvertently into the production process and then to "disable" the RFG from further use for patient safety.

• A drastic reduction in the business risk of having new and innovative therapeutic

devices copied and sold by unauthorized agents.

EXAMPLES

Example 1 Therapeutic System

00306 Figure 5 depicts one embodiment of the present invention. The system comprises a. a console comprising an RF generator and a controller configured for controlling the RF output of the RF generator;

b. a therapeutic device comprising:

i. an operational head configured for receiving the RF output and

delivering RF energy to the biological tissue; and II. a memory device comprising control instructions for said controlling the RF output; and

c. a reversible connector configured for operably linking:

I. the RF generator to the operational head; and

II. the memory device to the controller.

00307 The connector on the console side comprises a jack. The connector on the therapeutic device side comprises a plug configured for the jack.

00308 The operational head comprises an RF ablation head comprising a pair of electrodes configured in monopolar or bipolar mode. The operational head is configured as, e.g. a handpiece comprising an RF ablation catheter and/or needle.

00309 The memory operable linkage comprises a communications bus for linkage of the memory to the controller. The operational head operable linkage comprises a pair of electrical wires for linkage of electrodes on the operational head to the electrodes of the RF generator.

00310 The memory device can be provided anywhere on the therapeutic device, for example, in or on the connector (plug) of the therapeutic device.

00311 As depicted in Figure lA, the RF generator comprises an RF oscillator, an amplitude modulator, and a pulse modulator configured for control by the controller. Optionally, as depicted in Figure lB, the RF generator may be comprised of an agile RF generator from which the signal can be modulated by modulating the controlling signal rather than modulating the RF signal.

00312 Upon connection of the therapeutic device, the controller reads the control instructions stored on the memory device and controls the RF generator in the manner indicated by the control instructions. The control instructions comprise an algorithm or a set of parameters specific to the therapeutic device or a therapeutic procedure for which the therapeutic device is configured.

00313 The control instructions also comprise instructions for controlling a user interface, e.g. displaying information on the screen of the console including measured or monitored parameters, location and size of parameters, update rates of parameters. Further, the control instructions comprise the workflow of the generator, comprising the order of screens displayed, the information which is to be entered by the operator, the controls and conditions which must be activated and present in order to progress to a next state of the workflow. Such states may comprise of a standby state where the operator is asked to connect the therapeutic head, a programing state where the operator may adjust treatment parameters, patient information, or the user-interface preferences, a ready state where the generator is prepared to treat and is waiting for appropriate sensed conditions or activation of a control by the operator, a treatment state where energy is being delivered according to the algorithm specified by control instructions, an warning state where treatment continues but is approaching conditions which would cause treatment to stop, an alert state where the generator halted energy delivery because of inappropriate conditions of RF or a sensor input, an alarm state where the operator should take immediate action to prevent harm to the patient, and an error state where a fault with the generator or connected therapeutic device has been detected.

00314 Optionally, the system is configured depicted in the graphical representation of Figure 2. Optionally, the therapeutic device of the system is configured as depicted in the graphical representation of Figure 3. Optionally, the system is configured as depicted Figure 6.

Example 2 Therapeutic System

00315 A system of the invention (e.g. as detailed in Example 1) is provided, wherein the control instructions contain the specifications of energy parameters (e.g. power, voltage, waveshape, duty cycle, frequency, pulse frequency, pulse duration, impedance targets, and power adjustments to apply in response to impedance changes) for the RF energy to be applied to the treatment site to cut or ablate physiological structures.

00316 The power delivered by the energy generator is optionally specified to vary based on detection of rapid impedance changes, such as could be the case when localized boiling or 'popping' occurs. The control instructions optionally further specify impedance readings or trends which provide indications of proper or improper contact of electrodes to physiological structures. The control instructions optionally contain information as to how this information is to be displayed by the generator, containing characteristics such as text size, graph axes, update rate, filtering to be applied, colors to be used, units to be displayed, precision to be displayed, acceptable ranges of values to be displayed textually or graphically, and display and conditioning of sensor signals to trigger alarms or alerts. The control instructions optionally specify the parameters to be displayed on the screen during treatment, shown in a postprocedure report, contained in data log files, viewable over a connected web device, or any combination thereof. Example 3 Therapeutic System

00317 The system detailed in Example 2 is optionally further provided with one or more temperature sensors configured detect the changes in temperature of the electrode(s). The sensory input of the temperature sensors is used to limit the duration of treatment, alter the energy applied, or otherwise inform the operator of said temperatures. This function is provided by parameters in the memory device, e.g. minimum and maximum temperature limits, limits based on the rate of change of temperature, amount of alteration the energy delivery based on the temperature response observed at the electrodes, allowable ranges of thermal impedance (e.g. change in temperature as it relates to the rate or total quantity of energy delivered, or temperature response when energy is increased, reduced, or removed).

Example 4 Therapeutic System

00318 The system detailed in Example 3 is optionally further configured such that at least one of the temperature sensors is used to provide closed-loop temperature control of the electrodes. Here additional parameters contained in the control instructions specify how temperature is controlled, based on parameters such as target temperature or cumulative degree-seconds of ablation energy. Additionally the target temperature is optionally adjusted based on impedance changes which are indicative of changes in the tissue or tissue-electrode interface.

Example 5 Therapeutic System

00319 The system detailed in Example 2, Example 3, or Example 4 is optionally further configured to provide where a lumen or cannula for the application of fluid to the target ablation site to supplement the conductivity between the electrodes and the tissue. Here, additional parameters contained within control instructions specify the fluid flow, such as flow rate, pressure, target impedance, and target temperature.

Example 6 Therapeutic System

00320 The system detailed in Example 2, Example 3, or Example 4 is optionally further configured to provide where a lumen or cannula for the application of fluid to cool the target ablation site. Here, additional parameters contained within control instructions specify the fluid flow, such as flow rate, pressure, target impedance, and target temperature.

Example 7 Therapeutic System

00321 The system detailed in Example 6 is optionally further provided with additional lumens or cannulas for aspiration of the cooling fluids. Here, additional parameters contained in the control instructions specify the operations of the aspiration, such as negative pressure (vacuum), flow-rate, or temperature

Example 8 Therapeutic System

00322 The system detailed in Example 7 is optionally further configured such that the injection (i.e. infusion or irrigation) and aspiration of fluids are contained within a balloon or cavity within the therapeutic head and returned via aspiration to without contact with the targeted tissue.

Example 9 Therapeutic System

00323 The system detailed in any of Example 2 through Example 8 is optionally further provided with an ECG is sensor. The ECG sensor is provided either through an RF electrode, or via a separate sense electrode, or via additional therapeutic heads or therapeutic devices connected to the console. The ECG can be used for the purpose of synchronizing RF with cardiac activity. Here the control instructions contain information specifying the ECG morphological features to which RF should be synchronized, or detect that conditions are improper to deliver RF energy based on ECG rate or morphological features

Example 10 Therapeutic System

00324 The system detailed in any of Example 2 through Example 8 is optionally further provided with a fiber-optic lumen contained within the therapeutic device which conveys spectral information from which the chemical composition of ablation products can be monitored. Here the control instructions contain information which specified the spectrum of said products as well as the parameters and algorithms by which this information would affect energy delivery.

Example 11 Therapeutic System

00325 The system detailed in any of Example 2 through Example 10 is optionally further provided with a force sensor, active in one or multiple axes, configured to measure the application force of electrode(s) against a physiological structure at the target site. Here the control instructions comprise parameters such as contain force, frequency response, or time parameters which indicate proper/improper contact pressure, physiological pressure such as blood pressure, physiological pressures resulting from motion, such as cardiac contraction or respiration.

Example 12 Therapeutic System 00326 The system detailed in any of any of the previous examples is optionally provided with any of the following configurations: a. The operational head comprises: i. a monopolar needle ii. a bipolar needle iii. an array of needles connected in a monopolar fashion iv. an array of needles connected in a bipolar fashion v. an array of needles connected to more than one RF output. a) e.g. configured to combine bipolar and monopolar energy in a phased array; vi. a balloon device containing one or more electrodes on its surface. vii. a mesh or basket which expands to contact physiological tissue at the target site viii. an integrated lighting device; ix. an integrated lighting device and an imaging device.

Example 13 Therapeutic System

00327 A therapeutic system is provided, as depicted in Figure 7. The system comprises a. a console comprising an energy generator (e.g. RF generator) and a controller configured for controlling the energy output of the energy generator; b. a therapeutic device comprising:

I. an operational head comprising:

i. an energy delivery head configured for transmitting the energy output to biological tissue ; and

ii. at least one sensor;

II. a memory device comprising control instructions for said controlling the energy output;

c. a reversible connector configured for operably linking the RF generator to the energy delivery head; and d. a reversible memory operable linkage configured for operably linking the memory device to the controller.

00328 The energy delivery head can be any energy delivery head (e.g. RF head) such as an RF ablator, RF catheter, tissue ablator, or nerve ablator.

00329 The reversible connector can comprise a pair of interacting couplers. For example, the interacting couplers can be a jack/plug configuration, wherein the console provides a jack configured to accept a plug provided by the therapeutic device. The reversible connector provides housing for the energy operable linkage (e.g. electrically conductive members that transmit RF signals) that connects the energy generator to the energy delivery head.

00330 As depicted in Figure 7, the reversible connector can also provide housing for memory operable linkage that comprises a wired linkage, for example, electrically conductive members that transmit data between the memory device of the therapeutic device and the console controller. Alternatively, the memory operable linkage can be a wireless memory linkage such as Bluetooth. In systems with a wireless memory linkage, the controller can be configured to automatically connect to the wireless memory device upon detecting connection of the reversible connector. In either embodiment, the memory device can be optionally be comprised by the therapeutic device-side of the reversible connector, e.g. provided in or on a plug (not shown).

00331 As depicted in Figure 7, the reversible connector can also provide a housing for sensor linkage (e.g. a pair of wires) which connects the controller to the sensor of the therapeutic device. Alternatively, the sensor linkage can be wireless or can be wired and provided though a second reversible connector.

00332 The sensor can be a temperature sensor or other environmental sensor. The operational head can comprise the sensor in close proximity to the energy delivery head. For example, the operational head can be a catheter with an RF electrode on the outer tip and a sensor in the lumen at the catheter tip. .

00333 The system can be is configured to provide feedback to the controller or to the user (e.g. via a display or speaker). For example, the system can provide feedback from the temperature sensor (e.g. the temperature or operation status), connection status (e.g. of the therapeutic device to the console), authenticity of the therapeutic device (e.g. of

manufacturer), and use data (e.g. reuse/obsolescence data) of the therapeutic device. 00334 The memory device of the therapeutic device comprises control instructions such that, in operation with the controller, is programmed to deliver a therapeutic profile (e.g.

frequencies, amplitudes, crest factors, and/or pulse characteristics). The memory device or controller is further programmed to modify the therapeutic profile (e.g. starting, stopping, or changing energy delivery based on the monitored parameters) based upon feedback, e.g. of connection status, temperature, authenticity of manufacturer and reuse/obsolescence.

00335 The console further comprises a connection for a user input device such as a keyboard. The console further comprises a connection to a data network, such as the Internet, for conveyance of data, e.g. between the manufacturer and the health care provider.

00336 Optionally, the system provides one or more of the following advantageous features:

• Changes in therapeutic profiles, treatment algorithms, or settings can be programmed into the memory device of the therapeutic device, allowing use with a compatible console or RF Generator without the need of a software update.

• User interface changes may be programmed into the memory device of the therapeutic device, e.g. allowing different user-interaction with the system via different labels, instructions, screens, fields, or workflows.

• Therapeutic devices or operational heads thereof can be checked for authenticity, e.g. to prevent the use of counterfeit heads.

• Use data can be stored in the memory device of the therapeutic device and modified to indicate that the therapeutic device has been used, e.g. to prevent use on another patient.

• Calibration information may be stored in one or more therapeutic devices to facilitate more accurate energy delivery and more accurate data collection, including, e.g.

Operational Head temperature, patient temperature, impedance between one or more pairs of electrodes, rates of cooling, rates of impedance change

• Operation can be prevented when an invalid or unauthentic configuration is detected, providing additional patient safety.

• New therapeutic devices and operational heads may be introduced into the system

without prior updates of the console or generator.

• A console may simultaneously support the release of new therapeutic devices or

operational heads from different parties without prior knowledge or collaboration by these parties.

• The information in the memory device of the therapeutic device be used may update the software within the. Optionally future attachments of an identical therapeutic Head are then detected more quickly.

• Data collected during the procedure may be stored in the memory device of therapeutic device and returned to the manufacturer for post-treatment analysis, device performance tracking, etc.

• Data from the procedure, including therapeutic head usage and performance data, may be uploaded to the manufacturer for analysis.

Example 14 Therapeutic System 00337 A therapeutic system is provided. The system comprises a console and a therapeutic device e.g. in the manner detailed in Example 13, and further comprises a reversibly connected secondary device (e.g. irrigation device) comprising a reversibly connected memory device. An example is depicted in Figure 8.

00338 Specifically, the system comprises b. a console comprising an RF generator and a controller configured for controlling the RF output of the RF generator;

c. a therapeutic device comprising:

I. an operational head comprising an energy delivery head;

II. a first memory device comprising control instructions for said controlling the RF output;

d. first reversible connector configured for operably linking the RF generator to the energy delivery head of the therapeutic device;

e. a first reversible memory operable linkage configured for operably linking the first memory device to the controller;

f. an irrigation device as a secondary device comprising:

I. a fluid pump; and

II. a second memory device comprising instructions for controlling the fluid pump; and

g. a second reversible memory operable linkage configured for operably linking the first memory device to the controller;

h. second reversible connector configured for operably linking the controller to the fluid pump for control of the fluid pump; and

i. a sensor configured to sense an environmental condition (e.g. temperature) at the operational head.

00339 The fluid pump is configured to deliver and/or collect fluid to/from the biological tissue at the site of the energy delivery, e.g. by providing an irrigation head (e.g. infusion port) about the operational head. Optionally, operational head (e.g. irrigation head) of the fluid pump is comingled with the energy delivery head, e.g. fixed to the energy head and provided with the RF head as a single unit (e.g. to position the fluid pump head with greater precision relative to the RF head). For example, the operational head can be a catheter comprising at the catheter tip an energy delivery electrode, an irrigation port, and optionally a sensor.

Alternatively, the operational head of the fluid pump is separated from the RF head (e.g. to provide flexibility in positing the irrigation head).

00340 The fluid is optionally any of a surgical procedure fluid, a cooling fluid, saline irrigation, a contrast agent (e.g. for fluoroscopic visualization), or local fluid (e.g. aspirated fluid from a surgical site). Optionally, the fluid pump comprises a fluid reservoir configured to provide or collect fluid to/from the operational head of the fluid pump.

00341 Optionally, the fluid pump has its own controller that receives data (e.g. commands) from the console controller. Alternatively, the fluid pump optionally comprises a pumping mechanism that is directly powered and/or modulated by the console controller.

00342 The second reversible connector is configured for operably linking the controller to the fluid pump for control of the fluid pump. The operable linkage can be wired or wireless. For example, wired linkage can be used to provide electrical power from the console (e.g. for powering the pumping mechanism) or a data connection between the console controller and an optional fluid pump controller. Wireless linkage can be used, e.g. to provide a wireless data connection between the console controller and an optional fluid pump controller or to provide inductive power to the fluid pump. The second memory device comprises instructions for controlling the fluid pump. For example, the second memory device can contain the specifications or parameters of the pump such that the first memory device can, through the controller, set the operation of the pump to achieve the desired therapeutic profile.

00343 Optionally, at least one of the first and second memory devices can provide control instructions for (e.g. specify actions of) either the therapeutic device, the irrigation device, or both.

00344 Optionally, the system is configured to identify a specific combination of a therapeutic device and a fluid pump (e.g. when a plurality of alternative therapeutic devices and/or fluid pumps is provided). Optionally, at least one of the first and second memory devices comprises instructions specific to the combination of the therapeutic device and the fluid pump. Optionally, the first memory device comprises a plurality of control instructions, each specific to a different fluid pump. Optionally, the second memory device comprises a plurality of control instructions, each specific to a different therapeutic device. Optionally, at least one of the first or second memory device comprises instructions or information of the preferred programming (e.g. identification or ranking for program selections) for either or both of the fluid pump or therapeutic device, e.g. when the two are used in conjunction with each other in a system.

00345 With such as system, many advantages can optionally now be provided. For example: Optionally, the system provides one or more of the following advantageous features:

• Therapies requiring new combinations of operational heads may be created without first updating all deployed consoles.

• The provided therapy can be selected or modified by whichever memory device

contains the most-recent therapy information for the combination of Therapeutic Heads detected at the point of treatment.

• Software for both devices (therapeutic device and fluid pump) may be updated as

specified by the most-recently manufactured device or operational head thereof.

• Delivery of therapy is prevented where an inappropriate combination of devices or operational heads thereof detected.

• Data from the procedure may be stored in one or both of the first and second memory devices - allowing one or more parties to perform post-procedure performance review.

Example 15 Therapeutic System

00346 In this example, a system is provided as detailed in Example 14, with the exception that only one of the devices (e.g. therapeutic device or irrigation device) comprises a memory device with reversible operable linkage to the controller. The console recognizes the device that does not have its own reversibly linked memory device (e.g. via an analog or digital ID code) and controls the device.

00347 As one example, the reversibly linked memory device comprises instructions for controlling both devices (e.g. therapeutic device or fluid pump). In this example, the memory device of a single therapeutic device can be used to configure therapy from a plurality of d/t devices. As another example, the console comprises a local memory device (e.g. hard drive) comprising instructions for controlling the device which does not have a reversibly linked memory device.

00348 Similarly, for every embodiment taught herein to comprise a first memory device of a first therapeutic device and second memory device of a secondary device, comprising instructions for controlling the respective devices, the invention also provides an alternative embodiment comprising only one of the first and second memory devices, wherein said one of the first and second memory devices comprises instructions for controlling both the therapeutic device and the secondary device. Example 16 Therapeutic System

00349 A system of the invention is provided, e.g. .as depicted in Figure 9. The system comprises a first console and a second console. Each console comprises a controller and an energy generator. Each console is reversibly connected to a respective therapeutic device. Each therapeutic device is associated with a respective memory device reversibly linked to the respective controllers. Optionally, the first console and the second console are connected by a communications (i.e. data) link.

00350 As one example, a system is provided comprising:

00351 Specifically, the system comprises: a. a first console comprising a first energy generator (e.g. ventilator) and a first controller configured for controlling the energy output (e.g. pneumatic energy) of the first energy generator ('first energy output');

b. a first therapeutic device comprising:

I. a first operational head (e.g. patient tube circuit) configured for transmitting the first energy output to biological tissue (e.g. provides air pressure to the lungs); and

II. a first memory device comprising control instructions for said controlling the first energy output;

c. a first reversible connector configured for operably linking the first energy generator to the first operational head;

d. a first reversible memory operable linkage configured for operably linking the first memory device to the first controller;

e. a second console comprising a second energy generator (e.g. vaporizer) and a second controller configured for controlling the energy output (vaporized or atomized substances such as water or medicine) of the second energy generator ('second energy output');

f. a second therapeutic device comprising:

I. a second operational head configured for transmitting the second energy output to biological tissue (e.g. face mask for delivering vaporized substances; or inlet to a patient tube circuit or other vaporizer therapeutic head ; and II. a second memory device comprising control instructions for said controlling the second energy output;

g. a second reversible connector configured for operably linking the second energy generator to the second operational head;

h. a second reversible memory operable linkage configured for operably linking the second memory device to the second controller; and

i. optionally a communications link connecting the first controller and the second controller.

00352 Optionally, the system comprises a sensor (e.g. pressure sensor) reversibly connected to the first controller.

00353 As one example, the system can have a first console comprising a first energy generator which is a ventilator which applies pneumatic energy to reduce the patient energy required for respiration. A first therapeutic device is provided comprising an operational head, e.g. a patient tube circuit, configured for connecting the ventilator to the patient. The ventilator operational head is installed/removed from the ventilator via a first reversible connector. The first therapeutic device also comprises a memory device with control instructions for controlling the ventilator. This operational head delivers the pressurized air to the patient, and the controller controls patient pressure, e.g. reduces the patient pressure when appropriate, according to the control instructions. The Operational Head also includes a pressure sensor that senses the pressure at the point of treatment.

00354 The memory device of the first therapeutic device is reversibly connected to the controller, such as by a wireless connection (not shown) or a wired connection (e.g. through the first reversible connector as depicted in Figure 9). This memory device optionally comprises specific treatment parameters and algorithms which are suitable for use with the patient tube circuit or other operational head of the first therapeutic device. Optionally, the memory device comprises one or more calibration parameters such as tube resistance, pressure sensor calibration, and sterilization expiration date. Software updates (e.g. complete or partial) for the ventilator controller may also be contained in the memory device.

Optionally, the control instructions include pressure parameters or specifications and the controller receives pressure feedback from the pressure sensor and controls the ventilator in accordance with the pressure parameters or specifications of the control instructions, e.g. control the pressure at the point of treatment. 00355 Used in conjunction with the ventilator can be a vaporizer. A second console comprising a controller and vaporizer is provided. This vaporizer is optionally a nebulizer (e.g. which vaporizes or atomizes medications to allow them to be consumed via inhalation) or a humidifier (e.g. which vaporizes water, or saline-containing water, to control the humidity of the air delivered to the patient). A second therapeutic device comprising a vaporizer operational head and a memory device reversibly connected to the second console. The vaporizer operational head is configured to connect the vaporizer to the patient, e.g. comprises a facemask, is comingled with the operational head (e.g. patient tube circuit) of the ventilator (e.g. the vaporizer operational head comprises an inlet to the operational head of the ventilator), or is configured for use in combination with non-intelligent-connector ventilators.

00356 The memory device of the second therapeutic device is reversibly connected to the controller, such as by a wireless connection (not shown) or a wired connection (e.g. through the first reversible connector as depicted in Figure 9). The memory device comprises control instructions for controlling the vaporizer. Optionally, the control instructions comprise parameters specific to the vaporizer, such as flow rates, treatment intervals, dosages, or calibration parameters. Optionally, the control instructions comprise one or more treatment algorithms (e.g. instructions for periodic or conditional delivery of vapor). Optionally, the memory device comprises software updates (e.g. complete or partial) for the vaporizer controller, an optional vaporizer Ul, or both.

00357 The system can comprise a communications link connecting the ventilator console and the console of the vaporizer. This link is optionally any wired or wireless data link.

Examples include USB, Bluetooth, Firewire, Ethernet, RS-232, RS-485, and WiFi. A

communications link provides, e.g. a system of coordinated therapies.

00358 Optionally, the memory device of the ventilator therapeutic device comprises control instructions (e.g. parameters, algorithms or software) for the vaporizer controller. Optionally, the memory device of the vaporizer therapeutic device comprises control instructions (e.g. parameters, algorithms or software) for the ventilator controller.

00359 One or both of the consoles optionally comprises a connection for a user input device such as a keyboard. Optionally, the system is configured to allow user input and/or user output (e.g. display) of both systems using a single user input device and/or user output device, respectively. One or both consoles may further comprise a connection to a data network, such as the Internet, for conveyance of data between the manufacturers and the health care provider.

00360 With such a system, many advantages can optionally now be provided. For example:

• Therapies requiring new combinations of therapeutic devices or operational heads may be created without first updating all deployed consoles.

• The provided therapy can be selected or modified by whichever memory device

contains the most-recent therapy information for the combination of operational heads detected at the point of treatment.

• Software for both devices (or first and second therapeutic devices) may be updated as specified by the most-recently manufactured therapeutic device or operational head thereof.

• Delivery of therapy is prevented where an inappropriate combination of devices or operational heads thereof detected.

• Data from the procedure may be stored in one or both of the first and second memory devices - allowing one or more parties to perform post-procedure performance review.

• Consoles may be connected in the field to provide integrated therapies not contained within their original programming.

• Consoles may be combined and separated as required for particular installations and situations.

• Therapies requiring new combinations of operational heads may be created without first updating all deployed consoles.

Example 17 Therapeutic System

00361 In this example, a system is provided as detailed in Example 16, with the exception that only one of the therapeutic devices comprises a memory device with reversible operable linkage to its respective console. A communications link is provided between the first console and the second console. Through the communications link, the console with the reversibly linked memory device recognizes the other console or therapeutic device attached thereto and provides control instructions to the other console to control its energy generator (e.g. where control instructions for the other console are generic or understood)

00362 As one example, the reversibly linked memory device comprises instructions for controlling both consoles. As another example, the console with the reversibly linked memory device can comprise its own memory device (e.g. hard drive) comprising instructions for controlling the other console, e.g. instructions that are dependent on the control instructions provided by the reversibly linked memory device.

00363 In this example, memory device of a single therapeutic device can be used to control therapy from a plurality of consoles.

Example 18 Therapeutic System

00364 A system of the invention is provided. The system comprises a first console comprising a controller and an energy generator, and a therapeutic device and memory reversibly connected to the first console. The system further comprises a second console connected to the first console by a communications link. The second console comprises a controller and a diagnostic device connected to the controller. As example of such a system is depicted in Figure 10.

00365 As one example, the first console provides therapeutic energy (e.g. microwave or RF generator) while the second console provides imaging such as visualization, navigation, or other diagnostic functions e.g. CAT, PET, MRI, X-ray, or fluoroscopy. The first console comprises a controller connected to an energy generator which is reversibly connected to a therapeutic device comprising an ablation (e.g. microwave a blation) head or other energy delivery head as an operational head. The controller of the first console is reversibly connected to a memory device of the therapeutic device (e.g. in an optional plug thereof). The second console comprises a controller connected to a diagnostic device, e.g. that transmits and/or detects imaging energy. The first console and second console are connected by a communications link configured to transmit data between the console controllers.

00366 Using the examplary system set forth above, therapeutic energy such as energy in the microwave band can be used, e.g. to treat tumors in lung liver, kidney, bone and other biological tissues or organs. Such a system can additionally or alternatively be used to create lesions along specific nerves or groups of nerves. Although the example above specifies microwave as the ablation energy, the invention also contemplates the use of any therapeutic or ablation energy. For example, an energy generator can be a generator of any of the following energies: radio frequency energy, ultrasound energy, laser energy, cryoablation energy, plasma energy, electroporation energy, and high intensity focused ultrasound (H IFU) energy. Optionally, energy is delivered directly or in an interferential mode, the former which optionally selectively ablates tissue by combining the energy of two sources in a constructive manner at the desired point of ablation and reduces or eliminates ablation at other locations through destructive interference.

00367 Target biological tissue for ablation therapy can be selected, e.g. to block the conduction of sensor, motor, or combination nerve bundles to prevent either the sensory or motor functions associated with those nerves. Optionally, the therapy comprises sensory blockage, e.g. used for pain management applications or to affect the modulation of other body functions, such as in renal denervation (e.g. where the disruption of nerves associated with the renal system along the renal artery are ablated to cause a reduction in arterial blood pressure). Optionally, the system is used to ablate vascular and pulmonary structures for the treatment of, e.g. asthma or COPD.

00368 Optionally, such a system comprising a therapeutic device and an imaging device is used in therapeutic procedures where direct observation of the ablation by the physician is not possible. Such a system can be used to provide modeling, predictive calculations, visualization systems, and other indirect feedback (e.g. in the form of temperature and impedance readings) to provide the physician with the information required to complete the procedure.

00369 To provide efficacious treatment and accurate information to the physician through these indirect sensors it is useful for the parameters of the energy delivery and sensory devices to be known. Such parameters, such as size, distances, surface areas, impedances, calibration and correction factors, coupling factors, frequency-specific characterizations, resonant frequencies, opacity, among others, vary from device to device due to manufacturing processes and tolerances. In interferential treatments parameters of this type are particularly important because energy of various frequencies and wavelengths must be precisely applied, the calculation of which requires accurate spatial information concerning the separation of two or more points of energy application as well as characterization of the electromagnetic coupling of the energy to the patient. In this embodiment this unique information can be stored within the memory device of the therapeutic device. These parameters allow the predictive algorithms within the energy generator console to accurately deliver the energy required to obtain the predicted ablation results. The parameters can also be communicated to the Imaging console via the communications link where they are used, e.g. to improve the accuracy of the information provided to physician, as well as in any predictive calculations which this system may provide. For example, the energy generator console can send information to the visualization console such as the size, mass, or volume of an electrode on the therapeutic head so that the visualization system can incorporate these into the calculations of lesion size, shape, and/or position. As another example, the energy delivery console can send information such as antenna coupling coefficient(s), e.g. so that the visualization system can predict the amount of energy absorbed by the tissue vs. the amount transmitted so as to predict lesion size, shape, and/or position. As another example, the energy delivery console can send information such as distance and orientation between multiple electrodes (antenna), e.g. so as to predict the effects of the combination of energy from these multiple electrodes on the size, shape, and/or position of the lesion.

00370 Optionally, the imaging console sends data to the energy generator console, e.g. spatial and tissue characterization information back to the energy delivery system. In this example, the energy generator console optionally uses this data in combination with the unique parameters of the energy delivery head to control the energy generator, e.g. by adjusting treatment energies and/or selecting or modifying predictive algorithms appropriately.

00371 The reversibly connected memory device comprises control instructions for controlling the energy generator. Optionally, the control instructions comprise instructions for receiving feedback or other data from the second controller (i.e. the imaging device) and selecting or modifying algorithms or parameters. Optionally, the control instructions comprise algorithms (e.g. general algorithm methods), use data or reuse data, authentication information, system coordination information for the energy generator console and the imaging console, as well as software updates for one or both of the consoles.

00372 With such as system, many advantages can optionally now be provided. For example:

• Unique, accurate and consistent information regarding the parameters of the Operational Head can be provided to multiple consoles in the system.

• Parameters specific to the ablation of tissue and nerves by various energy modalities may be stored in the memory device of the reversibly connected therapeutic device.

Example 19 Therapeutic System with an Intermediate Device

00373 One embodiment of the invention provides a system comprising a console and reversibly connected therapeutic device with a memory device, wherein the system further comprises an intermediate device configured to provide an extension (e.g. greater than any of: 30 cm, 60 cm, 90 cm, 120 cm, or 150 cm) between the therapeutic device and the console, e.g. as depicted in Figure 11. Optionally, the intermediate device and the therapeutic device each comprise an independent memory device comprising control instructions specific to their respective device.

00374 Optionally, the memory devices of both the intermediate device and the therapeutic device comprise parameters or other instructions associated with their respective device (e.g. software, capabilities, impedance, loss factors, or frequency characterization). These parameters can be used, e.g. by the controller to provide a safe and efficacious treatment.

00375 Optionally, the memory devices of one or both of the intermediate device and the therapeutic device comprise one or more instructions selected from recommend number of uses, authentication and re-use prevention rules, and sterilization validity information.

00376 Optionally, a plurality of therapeutic devices and/or a plurality of intermediate devices are provided that can alternatively be combined to form a system. With this embodiment, different intermediate device/therapeutic device combination can produce different systems, each with their own capabilities and uses.

00377 Such a system allows, e.g. for situations in which the intermediate device and the therapeutic device, or memory devices thereof have different production dates. For example, therapeutic devices or intermediate devices may have been produced at different times with different ideal combinations of software and parameters specified for the treatment procedure. Optionally, data stored on at least one of the devices (e.g. newest device) to provide updates or information that allows the controller to control the energy generator in accordance with the given combination of therapeutic device and intermediate device.

00378 In this example, the system comprises an intermediate device comprising an extension (e.g. cable) reversibly connected on one end to the console and reversibly connected on another end to the therapeutic device. The intermediate device is configured in any manner that provided an operable linkage to connect the energy generator and the therapeutic device. Optionally, the intermediate device further comprises an operable linkage for the memory device of the therapeutic device. Optionally, the intermediate device further comprises a memory device. The intermediate device can be configured, e.g. as a separable cable, enabling a physician to span a substantial distance between the console and the therapeutic device. This configuration can allow, for example, an intermediate device to be provided as a reusable extension that is not sterilized between reuse while the therapeutic device is sterilized between reuse. As another example, this configuration can also provide systems in which the therapeutic device is a single-use device, but the cable may be re-used. This can substantially reduce expense of materials when lengthy cabling is needed to connect the console to the operational head. A system comprising an intermediate device can also be implemented, e.g. where different lengths of cables are appropriate for different situations or therapeutic procedures.

00379 Although the example detailed above provides a single intermediate device, a system can optionally comprise a plurality of intermediate devices, each serially reversibly connected to the next, with the console at one end, and the therapeutic device at the other end.

Optionally, each intermediate device comprises its own memory device.

00380 Optionally, the system comprises configuration management software. Such software can be configured to allow the controller to receive, interpret, and/or implement control instructions or other data from a plurality of simultaneously connected memory devices of respective reversibly connected devices. Such software is optionally configured for conflict resolution between control instructions provided on respective memory devices of a therapeutic device and an intermediate device. Optionally, the configuration management software is configured to identify an inconsistent or incoherent combination of two or more sets of control instructions provided by respective memory devices and provide a set of control instructions for a therapeutic procedure (e.g. by selecting a set of control instructions from one of the memory devices or producing a set of control instructions by selecting portions of the control instructions provided on two or more memory devices). For example, combinations of devices into a system may cause conflicts where the parameters or other instructions stored within the memory device of the therapeutic device is inconsistent or incoherent with parameters or other instructions stored in the memory device of the intermediate device (or other devices of a serially connected chain). Examples of inconsistent or incoherent combinations of control instructions that can be identified by the configuration management software include a) two memory devices, each containing a software update for one or more consoles which are different from the other; b) two memory devices, each containing settings or treatment algorithms which are different from the other; c) a memory device which contains settings, and a console which also contains setting for that device which are different from each other; d) a memory device which contains software for the console, attached to a console which already contains a newer software release; e) a memory device whose settings specify use with a set of accessories/console(s) connected to a console which specifies that device for use with another set of accessories/console(s); f) two memory devices containing software with a different version (e.g. mismatched software revisions or dates); g) two memory devices wherein at least one of the memory devices contains a list of compatible d/t devices (or consoles) that does not include the d/t device (or console) associated with other memory device (e.g. an "unexpected device"); h) two memory devices wherein at least one of the memory devices contains a list of incompatible d/t devices that includes the d/t device associated with other memory device; i) incompatible equipment combinations of therapeutic or diagnostic devices; or j) Software or hardware versions of part of the system not known to be compatible with the device or other parts of the system.

00381 This conflict resolution function of the configuration management software is optionally configured perform steps of collecting data (e.g. control instructions, identifiers, parameters, algorithms) from a memory device of each chained device and making a determination of the most-appropriate combination of software, parameters, and/or algorithms to use during patient treatment. This can be done, e.g. to ensure that the most- recent and most-appropriate treatment is provided. Examples of determinations that can be made include a) the selection of the target temperature when the memory device of a therapeutic device and a memory device of the console each contain control instructions specifying a different temperatures (e.g. the conflict resolution software can be configured to select the target temperature provided by the memory device of the therapeutic device); b the selection of a software version when the memory of the therapeutic device contains a different software version than a memory device of the console (e.g. software is configured to select the software provided by the therapeutic device memory, e.g. downgrading if the console memory contains a more recent software version than the therapeutic device memory; or c) a therapeutic device memory comprises instructions for operation of a particular secondary device (e.g. a cooling pump) but the console detects that a different secondary device is connected (e.g. a different cooling pump) and the console memory device contains control instructions such as business rules for said different secondary device, then, e.g. the conflict resolution software can select the appropriate control instructions for the connected secondary device, resulting in effective treatment being performed using the different secondary device.

00382 In order to provide the configuration management software with the information that can be used to determine this optimal configuration, sets of business and clinical rules are embedded in one or several of the memory devices. Some examples of the rules which may be included are:

1. identifications of combinations of other devices are compatible with a particular device.

2. identifications of which software is compatible with device combinations

3. instructions for selecting a software version from one of the memory devices (reversibly or non-reversibly connected memory devices), e.g. instructions downgrade system software or to utilize newer software provided by a reversibly connected memory device when a console's memory device (e.g. non-reversibly connected) contains more-recent software or information than that specified by any currently connected device

4. override rules, e.g. when instructions on a reversibly connected memory device indicates that its respective therapeutic device or intermediate device chain has use limitations (e.g.an override rule that specifies whether treatment can proceed if a device has met or exceeded its use or re-use limit

5. error-processing rules, e.g. when memory is not present in a reversibly connected device, or cannot be read, the error-processing rule specifies if treatment can proceed.

6. data-write rules, e.g. specifies which memory device, or devices, if any should be written with data or feedback from the current procedure?

7. display rules, e.g. specifies the information should be displayed to the operator for a unique combination of devices

00383 With such as system, many advantages can now optionally be provided. For example:

• devices within a system may be separable to reduce cost or increase functionality which retaining the benefits of earlier embodiments.

• authenticity (e.g. anti-counterfeiting) may be enforced on all devices in the system.

• software and treatment updates may be introduced into the system by the most-recently manufactured portion of the system rather than a particular portion of the system.

• portions of the system of devices may not include unique memory devices at the discretion of the manufacturer, for example, the therapeutic device may not contain its own memory device in order to reduce cost but the separable cable, due to a less-frequent replacement cycle, may incorporate a memory device with control instructions for use with a therapeutic device.

• energy delivery consoles may provide connectors of different size and configuration than the therapeutic device. For example, the intermediate device (e.g. separable cable) can provide the physical translation of connections and the memory device within the intermediate device provides the logical and clinical translation for using a particular therapeutic device with the console.

Example 20 Treatment Algorithm

00384 A system of the invention is provided comprising an ablation energy generator and a therapeutic device with an energy delivery head comprising electrodes (e.g. RF electrode). The system comprises a treatment algorithm, for example, stored on a console memory device or the therapeutic device memory.

00385 The treatment algorithm is configured to deliver therapeutic energy (e.g. RF ablation energy) and comprises a plurality of steps:

1. Detect the connected device and retrieve parameters or other data from the therapeutic device memory (e.g. which may provide the settings used, or represent the entirety the algorithm steps below)

2. Delay until conditions are simultaneously met, e.g. each of:

a. The impedance between two electrodes is within an allowable range (e.g. 50 to 300 ohms)

b. The temperature at the electrodes is within an allowable range (say 35 to 41C) c. The 'energy activation' button is pressed.

3. Begin energy delivery, e.g. starting at a first power (e.g. 0.0W) and increasing (e.g. linearly) power (e.g. 10.0W over 30 seconds). Optionally

a. If the impedance exceeds a limit (e.g. 300 ohms) stop treatment

b. If the temperature exceeds a limit (e.g. 80°C) stop treatment

4. Apply up to given power limit (e.g. 10W) to achieve and maintain a target temperature (e.g. 85°C). Optionally,

a. After 30 seconds stop treatment

b. If more than 200 Joules are delivered stop treatment

c. If the impedance exceeds 400 ohms stop treatment Example 21 Control Algorithm

00386 A system of the invention is provided comprising an irrigation energy generator (e.g. peristaltic pump) and a therapeutic device with an irrigation head. The system comprises a control algorithm, for example, stored on a console memory device or the therapeutic device memory.

00387 The control algorithm is configured to deliver fluid flow or other irrigation by controlling the following steps:

1. Detect the connected device and retrieve parameters or other data from the therapeutic device memory (which may inform the controller of the settings, parameters, or the entirety, of the algorithm below).

a. Retrieve the energy output parameter of 'flow rate' . By example, the memory device includes a plurality of flow rate settings that may adjusted by the operator within a specified range (e.g. of either 10, 15, 20, 25, or 30 ml/min).

2. The operator (i.e. user) is queried to select the flow rate from these choices

3. The operator selects a flow rate (e.g. 20ml/min)

4. The operator actuates the control to begin cooling fluid flow

5. The controller retrieves information from its internal Calibration Parameters that a pump speed sensor will report an increase in its value (e.g. 1.0V for every 24.8 roller-strokes per minute).

6. The controller retrieves Internal Calibration Parameters from a console memory device that describe the fluid pump characteristics (e.g. indicating that each roller-stroke produces 32.8 mm of linear displacement)

7. The controller retrieves calibration parameters from the therapeutic device that indicate the inner diameter of the irrigation tubing (e.g. 2.04mm).

8. The controller uses the parameters to compute the voltage value which the sensor will report when the selected flow rate (e.g. 20.0ml/min) is being delivered. This is the target value the controller will attempt to maintain.

9. The controller reads a pump speed sensor and compares this to the target value.

10. According to a control law, such as a Proportional, Integral, and Derivative (PID) control loop. The gains of the parameters in the control loop may be fixed, specified by internal calibration parameters within the console, or specified by a set of calibration parameters within the therapeutic device memory to achieve the correct therapeutic outcome. 11. The controller continues to perform steps 10 and 11 periodically to maintain the desired flow until the operator de-activates flow, or an error or anomaly occur.

Example 22 Predictive Algorithm

00388 A system of the invention is provided comprising an ablation energy (e.g. RF) generator and a therapeutic device with an energy delivery head comprising. The system comprises a predictive algorithm, for example, stored on a console memory device or the therapeutic device memory.

00389 As one example, the predictive algorithm is configured to make a lesion prediction using the following steps:

1. Detect the connected therapeutic device and retrieve parameters or other data from

memory device (which may inform the settings, parameters, or the entirety, of the algorithm below)

2. Operator selects the size of lesion to create

3. Delay until all of the conditions are simultaneously met, e.g.:

a. The impedance between two electrodes is within an allowable range (e.g. 50 to 300 ohms)

b. The temperature at the electrodes is within an allowable range (e.g. 35 to 41°C) c. The 'energy activation' toggle button is pressed.

4. Controller monitors the time, impedance, temperature, and energy delivered and makes a prediction of the lesion size based on a computerized model. The model may, for example, be based on the heat equation of a specific volume of tissue, perfused at a certain blood flow rate, at a certain depth of probe insertion.

5. Controller halts the treatment if a limit (e.g. boundary condition) is violated (e.g. maximum or minimum impedance reached), or when predicted lesion size reaches that specified by the operator.

00390 As another example, the predictive algorithm is configured to make a lesion adaptive prediction using the following steps:

1. Detect the connected therapeutic device and retrieve parameters or other data from the therapeutic device memory (which may inform the settings, parameters, or the entirety of the algorithm below)

2. Operator selects the size of lesion to create 3. Delay until all of the following conditions are simultaneously met, e.g.:

a. The impedance between two electrodes is within an allowable range (e.g. 50 to 300 ohms)

b. The temperature at the electrodes is within an allowable range (e.g. 35 to 41C) c. The 'energy activation' button is pressed.

4. Controlling computer monitors the time, impedance, temperature, and energy delivered and makes a prediction of the lesion size based on a computerized model of the laws of nature. The model may, for example, be based on the heat equation of a specific volume of tissue, perfused at a certain blood flow rate, at a certain depth of probe insertion. Such a model may be an explicit closed solution, or may be approximated by finite-element solutions. Based on the combination of the monitored parameters the (time, temperature, energy delivered, impedance) the computer modifies its model, or model parameters, or the system. Such adaptive control and parameter estimation algorithms are known in the art, (i.e. Least Squares, or those proposed by Lillacci, PLoS Comput Biol. 2010 Mar

5;6(3):el000696. doi: 10.1371/journal.pcbi.1000696. Parameter estimation and model selection in computational biology. Lillacci G, Khammash M. Center for Control, Dynamical Systems and Computation, University of California at Santa Barbara, Santa Barbara, California, United States of America, or Slotine "Applied Nonlinear Control" (Slotine and Li, Prentice-Hall, 1991))

5. The updated model or parameters are then used to more accurately predict the lesion size.

6. Controller halts the treatment if a boundary condition is violated (i.e. maximum or

minimum impedance reached), or when predicted lesion size reaches that specified by the operator.

Example 23 System Comprising Parameters

00391 A system of the invention is provided comprising a first console having a first energy generator and a first therapeutic device comprising a memory device and a first energy delivery head configured for transmitting the first energy. The first energy generator is selected from a wave energy generator, a pneumatic energy generator, a vaporizer, a plasma energy generator, a cryoablation energy generator, an irrigation energy generator (e.g. fluid pump), and an electroporation energy generator. The first therapeutic device and first therapeutic device memory are reversibly attached to the console, e.g. by a first reversible connector. Optionally, the system comprises a user interface device (Ul) such as a display. Optionally, the system comprises one or more sensors. Optionally, the system further comprises one or more secondary devices reversibly attached to the console such as an imaging device, an

intermediate device, a second therapeutic device, and/or a second console comprising a second energy generator. Optionally, the one or more secondary devices comprise respective memory devices.

00392 The first therapeutic device memory comprises one or more parameters selected from (e.g. each of) therapeutic energy output parameters (e.g. of the first energy generator and/or optional second energy generator), Ul output parameters, calibration parameters, verification parameters, and capability parameters. The optional calibration parameters, verification parameters, and capability parameters describe the therapeutic device or hardware thereof (e.g. an energy delivery head). Optionally, the memory device comprises one or more alternatively selectable parameter settings (e.g. as listed under 'device settings').

00393 The optional memory device of the optional secondary device comprises one or more parameters selected from (e.g. each of) therapeutic energy output parameters (e.g. of the first energy generator and/or second energy generator), Ul output parameters, calibration parameters, verification parameters, and capability parameters. The optional calibration parameters, verification parameters, and capability parameters describe the secondary device or hardware thereof (e.g. an energy delivery head or sensor). Optionally, the memory device comprises one or more alternatively selecta ble parameter settings (e.g. as listed under 'device settings').

00394 At least the first console comprises a local memory device comprising system software (e.g. operating system and/or framework) configured to cause the console controller to obtain the parameters from the reversibly connected memory devices. The local memory device of the first console also one or more algorithms (e.g. treatment algorithms, control algorithms, and/or predictive algorithms) that reference the parameters, e.g. as independent variables of equations or treatment steps. Additionally or alternatively, the reversibly connected memory device(s) comprise algorithms that are obtained by the console controller.

00395 Selection of the parameters stored on respective reversibly connected memory devices is made from the following parameter list, which provides categories of useful parameters, and specific examples thereof. The skilled artisan will immediately recognize that the selection of parameters is based, in part, on the selection of energy generator(s), therapeutic device(s), and/or secondary device(s).

Parameter List

Therapeutic Energy output parameters

Wave energy output parameters

• electromagnetic wave output (e.g. RF or microwave) parameters o voltage, current, temperature, duty-cycle , pulse rate, pulse duration, pulse shape, ramp time, treatment time, joules delivered, frequency, waveshape, power, phase, and channel used,

• sonic energy output (e.g. ultrasound or H IFU) parameters

o Beam intensity, beam phase, power, frequency, channels used, duty cycle, current, voltage, pulse rate, pulse duration, pulse shape, ramp time, treatment time, waveshape, phase, joules delivered.

• laser energy output parameters

o Average power, peak power, beam intensity, beam size, voltage, current, duty-cycle, pulse rate, pulse duration, pulse shape, ramp time, treatment time, phase, joules delivered, channels used

• Nerve stimulation energy output parameters

o stimulation rate, waveshape, current, voltage, pulse rate, pulse duration, pulse shape, ramp time, treatment time, frequency, phase, power, channel used.

Mechanical Energy output parameters

• Irrigation output parameters

o Flow rate, pressure, pump speed, pump torque, flow shape, ramp time, duration, volume delivered

Plasma energy output parameters • gas flow rate, power, voltage, initiation output level, duty cycle, pulse rate, pulse duration, pulse shape, ramp time, treatment time, joules delivered, channels

Cryoablation output parameters

• Coolant flow, thermoelectric power, thermoelectric current, coolant pressure, pulse frequency, pulse duty cycle, ramp rate, treatment time.

Electroporation parameters

• Voltage, charge, pulse rate, pulse width, joules, number of pulses, treatment duration.

U l output (e.g. display) parameters

Notification parameters

• Data displayed

o Screens

o triggers, and ranges of acceptable values

o All other parameters taught herein

• warning, alerts, alarms

display parameters

• text size, graph axes, update rate, filtering, color, units of values, precision of values,

Capability parameters

compatible or incompatible modes of operation, compatible or incompatible therapeutic devices, compatible or incompatible consoles or energy generators

Verification parameters

o use data; recommend number of uses; model number; company/brand; Produced for; Production Plant; time or date of production; maximum number of uses allowed; authentication (e.g. key) of a local device (e.g. authentication of a therapeutic device provided on therapeutic device memory); authentication of a remote device (e.g. authentication of an intermediate device provided on therapeutic device memory); re-use prevention rules; sterilization validity information; sterilization expiration date ; device serial number; device authorized for use for this system ; device authorized for use in the country or geography in which this system was sold; device authorized for use with this system based on systems owner; device authorized for use with this system based on system's brand name; device authorized for use with this system based on feature set; device authorized for use with this system based on the total number of treatments authorized for this system; device authorized for use with this system based on the re-use history of this device; authentication keys of data stored on the memory device, e.g. software updates encrypted with symmetric (single key) or asymmetric (public/private) methods, the validity of which must be confirmed before the system will provide therapy, authentication keys encrypted with symmetric (single key) or asymmetric (public/private) methods, the validity of which must be confirmed before the system will provide therapy.; authentication Keys for or memory device data such as parameters encrypted with symmetric (single key) or asymmetric (public/private key) methods, the validity of which must be confirmed before the system will provide therapy

Calibration parameters

Energy delivery head calibration parameters

• wave energy delivery head (e.g. RF electrode) parameters

o calibration parameters for energy delivery

loss factors, impedances, including for example R-L-C values, Z and Phase, complex Z and S parameters, surface area, maximum energy allowed, diameter, energy coupling factors, physical lengths (needles, tips, probes, cables), electrode exposure lengths, distance between electrodes, impedances between electrodes, impedance between channels or wiring leads, resonant frequencies, thermal impedance, thermal time constant, temperature feedback gains, offsets, and characteristic equations, cooling flow rates, o calibration parameters (e.g. electrode parameters) for

imaging

length, area, mass, orientation, volume, opacity, or antenna coupling coefficient of the first energy delivery head)

• pneumatic pressure head and/or vaporizer head (e.g. ventilator or vaporizer head such as patient tube) parameters

o tube resistance, tube diameter, tube volume, tube length, pressure vs. flow characteristic equation parameters, vaporizer output characteristic equations, leak rate, 02 Perfusion sensor characterization curves, 02 sensor gains/offsets/characteristic equation parameters,

• Irrigation head (e.g. irrigation catheter) parameters

o tube diameter, tube volume, tube length, maximum pressure allowed, maximum flow rate allowed, pressure vs. flow characteristic equation parameters, recommended flow rate, balloon volume, flow vs. cooling characteristic equation parameters, electrode size, pressure measurement characteristic equation parameters,

Intermediate device calibration parameters

• Impedance, Loss factors, Frequency characterization, Length, Contact impedance, Temperature measurement characteristic equation parameters, Pressure measurement characteristic equation parameters, Inter-signal impedances

Sensor calibration parameters

• pressure sensor parameters

• temperature sensor parameters

Input parameters (e.g. monitored value provided as a trigger value, target value, or value limit, or derived values used to control treatment)

o an environmental condition

• Therapeutic- or side- effect of treatment

o air pressure, temperature, chemical composition o biological condition or physiologic condition

• Therapeutic- or side- effect of treatment

o ECG, EEG, EMG, or EOG, heart rate, respiration, Oxygen

saturation Level, Carbon dioxide saturation level, De- oxygenated hemoglobin level, Blood pressure, Breath rate, Blood flow, Muscle contraction

o therapeutic device condition

contact force or pressure, temperature, acceleration, impedance, phase, volume, position, disconnection, flow rate, chemical composition, rate of change of impedance, rate of change of temperature, rate of change in pressures, change in power required to maintain temperature, change in power required to maintain impedance, change in power required to maintain pressure, change in power required to maintain flow

o image parameter

image contrast (e.g. monitored image contrast to trigger delivery of

additional contrast agent), radiological marker movement, radiological marker position

o user input status (e.g. toggle switch)

o monitored energy output parameters

Energy delivery head calibration parameters

• wave energy delivery head (e.g. RF electrode), Treatment

Temperature, Treatment Time, Power, Voltage, Stim amplitude, Stim rates, Stim pulse width, Electrodes to energize, Fluid Flow rate, Duration of treatment, Joules to deliver, Size of lesion, Shape of lesion, Joules to absorb (cooling), Maximum voltage, Maximum flow rate, Minimum Flow rate, Channels to use, Type of procedure , Anatomy targeted, Data output formats, Audible volumes pneumatic pressure head and/or vaporizer head (e.g. ventilator or vaporizer head such as patient tube) • fluid flow rate, fluid volume to deliver, humidification level,

Pneumatic flow rate, Pneumatic pressure, Patient type

(adult/pediatric, weight, age, gender), Breath Modes allowed, Breath rates allowed, Tidal volumes allowed, Spontaneous breath intervals allowed, Breath rate alarms, Breath tidal volume alarms, Forced- breath timeout , Breath Mode parameters, Intra-cycle pressures (i.e. PIP), Inter-cycle pressures (i.e. PEEP), Target oxygen perfusion, Vascular support pressures, Vascular support pressure gradients, Vascular compression rates

Irrigation head (e.g. irrigation catheter)

• tube diameter, Volume to inject, Contrast agent flow rate, Pressure to maintain, Maximum pressure to allow, Allowable leakage rate, Bubble detection sensitivity, Fluid pre-heat/cool temperature

00396 The citations provided herein are hereby incorporated by reference for the cited subject matter.

Claims

claimed is:
A system comprising:
a. a console, wherein the console comprises an energy generator and a controller, wherein the controller is configured for controlling the energy output of the energy generator;
b. a therapeutic device comprising:
i. an operational head configured for transmitting the energy output to a target site; and
ii. a memory device comprising control instructions, wherein said control instructions comprise energy control instructions for said controlling the energy output;
c. a reversible connector configured for operably linking the energy generator to the operational head; and
d. a reversible memory operable linkage configured for operably linking the
memory device to the controller; and
e. optionally, the energy generator is a radio frequency ('RF') generator and the operational head comprises one or more RF electrodes.
The system of Claim 1, wherein the control instructions comprise one or more parameters or one or more executable instructions.
The system of Claim 2, wherein the control instructions comprise one or more parameters of energy output, one or more parameters of sensory input, or both.
The system of Claim 3, wherein the one or more parameters of energy output are selected from: target value, value limit, maximum value, minimum value, and value trend or pattern.
The system of Claim 3 or Claim 4, wherein the one or more parameters of energy output are selected from: voltage, power, current, energy frequency, pulse frequency, pulse duration, duty cycle, waveshape, impedance, thermal impedance, ramp time, and stimulation rate.
The system of Claim 5, wherein the one or more parameters of energy output comprise a target value of energy output or a limit of a value of energy output
7. The system of Claim 3, 4, or 6, wherein the one or more parameters of energy output comprise:
a. voltage;
b. power or current;
c. energy frequency;
d. at least two of: pulse frequency, pulse duration, and duty cycle
e. waveshape;
f. impedance;
g- a, b, and either c, d, or both;
h. a, b, c, and either d, e, or both;
i. a, b, c, and either d, f, or both;
j- a, b, c, and either e, f, or both; or
k. each of a-f.
8. The system of any of Claims 3-7, wherein the one or more parameters of sensory input are selected from:
a. temperature
b. heart rate,
c. sensed parameter of energy output;
d. EMG
e. ECG;
f. image;
g. fluid flow rate;
h. chemical composition.
i. force;
j. pressure; and
k. a target value or value limit of any of the preceding sensory inputs.
9. The system of Claim 3 or Claim 8, wherein the one or more parameters of sensory input are triggers of one or more steps of control of energy output or of a secondary device, optionally, wherein said one or more steps of control of energy output comprise initiation of energy output or termination of energy output.
10. The system of Claim 1 or Claim 2, further comprising one or more input or output (Ί/Ο') devices, wherein said control instructions comprise instructions for controlling the one or more I/O devices, and optionally wherein: a. the one or more I/O devices are comprised by the console or the therapeutic device; and
b. the one or more I/O devices are selected from:
i. a user interface ('U l') comprising at least one user output device and at least one user input device;
ii. an input device comprising one or more sensors;;
iii. an output device comprising one or more secondary therapeutic devices; and
iv. a log storage device comprising a procedure log file, optionally wherein the log storage device is local to the console or networked with the console.
11. The system of Claim 10, wherein:
a. the control instructions comprise one or more algorithms configured for
controlling one or more output devices based on the input from one or more input devices; or
b. the control instructions comprise one or more parameters of energy output or sensory input or both, and the console comprises local memory comprising one or more algorithms configured to:
i. obtain the one or more parameters from the control instructions; and ii. control the one or more output devices based on one or more
parameters.
12. The system of Claim 11, wherein:
a. the one or more output devices are selected from:
the energy generator;
ii. a user output device;
iii. a log file storage device;
iv. a secondary therapeutic device
v. any combination thereof;
vi. a combination of i and ii; and
vii. a combination of i, ii, and iii;
The system of Claim 11 or Claim 12, wherein the one or more input devices are selected from:
a. one or more sensors; b. a user input device; and
c. a combination thereof.
14. The system of Claim 2, wherein the control instructions comprise an algorithm
configured for:
a. sensing a parameter of RF output or an environmental condition of the RF
output; and
b. controlling one or more output devices based on the sensed parameter.
15. The system of Claim 14, wherein sensed parameter is an impedance parameter,
optionally wherein the impedance parameter is selected from: a value of impedance, a change in the value of impedance, a rate of change in the value of impedance, a limit of impedance value, and a trend of impedance values
16. The system of Claim 15, wherein the impedance parameter is a rapid change of
impedance value, optionally, wherein the rapid impedance change is the change in impedance caused by local boiling or popping in proximity to the operational head or at the target site.
17. The system of Claim 15, wherein the impedance parameter is an impedance value or a trend in impedance values a trend, wherein the impedance parameter indicates proper or improper contact of electrodes to a target site.
18. The system of any of Claims 13-17, wherein controlling at least one device comprises modulating the power of the energy output.
19. The system of any of Claims 13-18, further comprising a user output device, wherein controlling at least one output device comprises controlling the user output device.
20. The system of Claim 19, wherein the user output device comprises a visual output device, an audio output device, or both.
21. The system of Claim 20, wherein the control instructions specify a parameter of user output selected from: text size, graph axes, update rate, filtering, color, units of values, precision of values, acceptable ranges of values, and value or conditioning of sensor signals to trigger alarms or alerts.
22. The system of Claim 20 or Claim 21, wherein the control instructions comprise providing an alarm or displaying a real-time report or a post-procedure report.
23. The system of any of Claims 13-22, wherein controlling at least one device comprises writing a report to a digital file.
24. The system of any of Claims 10-12, wherein the one or more secondary therapeutic devices are selected from:
a. a fluid pump;
b. an expandable device;
c. a lighting device;
d. a cauterizing device; and
e. a cutting device.
25. The system of any of Claims 10-12 and 24, wherein the one more input devices
comprise one or more sensors selected from:
a. a temperature sensor;
b. heart rate sensor,
c. a sensor of an energy output parameter;
d. an EMG sensor;
e. an ECG sensor;
f. an imaging device;
g- a fluid flow sensor;
h. a chemical sensor.
i. a force sensor; and
j- a pressure sensor.
26. The system of Claim 25, wherein the temperature sensor is configured for sensing the temperature of the operational head or the target site, optionally wherein the operational head comprises an energy catheter and the temperature sensor is in the catheter, optionally wherein the energy is RF energy.
27. The system of Claim 26, wherein the control instructions one or more temperature parameters, optionally wherein the one or more temperature parameters are selected from: a temperature limit, a change in temperature, a rate of change in temperature, and a trigger parameter.
28. The system of Claim 26, wherein the control instructions comprises instructions for controlling one or more output devices based on the input from one or more input devices, wherein said controlling comprises any of:
a. modulating the energy output;
b. limiting the duration of energy output;
c. modifying the energy output; d. terminating energy output; and
e. presenting the temperature, change in temperature, or rate of change in
temperature through the user output device.
29. The system of Claim 28, wherein the temperature parameters comprise one or more of: a. temperature limit, optionally wherein the temperature limit comprises a
minimum temperature, a maximum temperature, or both;
b. temperature rate of change limit;
c. temperature change;
d. temperature rate of change relative to the rate or total quantity of energy
delivered; and
e. temperature change when energy is increased, reduced, or removed.
30. The system of Claim 28, wherein the therapeutic device comprises at least one
temperature sensor configured to provide closed-loop temperature control of energy emitting electrodes, optionally wherein the energy emitting electrodes are RF electrodes.
31. The system of Claim 30, wherein the control instructions comprise one or more
parameters or algorithms configured to modulate temperature.
32. The system of Claim 31, wherein the control instructions comprise one or more of: a. a target temperature;
b. a cumulative degree-seconds of ablation energy; and
c. an impedance change indicative of changes in the tissue or tissue-electrode interface.
33. The system of Claim 24, wherein the system comprises one or more fluid pumps and the therapeutic device comprises one or more lumens or cannulas configured for transmitting one or more fluids between the one or more fluid pumps and the operational head or target site.
34. The system of Claim 33, wherein the control instructions comprise a parameter
configured to control flow rate of the fluid, optionally wherein the parameter is selected from:
a. flow rate;
b. pressure;
c. target impedance; and
d. target temperature.
35. The system of Claim 33 or Claim 34, wherein the at least one of the one or more lumens or cannulas is configured to irrigate fluid to the operational head or target site.
36. The method of Claim 35, wherein the at least one of the one or more lumens or
cannulas is configured to aspirate fluid from the operational head or target site.
37. The system of Claim 36 where the irrigation and aspiration fluids are contained within a balloon or cavity within the therapeutic head, and the system is configured to transmit fluid to and from the operational head or electrodes thereof without contacting the targeted tissue.
38. The system of any of Claims 25-37, wherein the one or more sensors comprise an ECG, wherein the control instructions comprise an ECG parameter.
39. The system of Claim 38, wherein the ECG parameter comprises one or more ECG
morphological feature or ECG rate.
40. The system of Claim 39, wherein the system is configured to modulate or synchronized energy output based on the ECG parameter.
41. The system of any of Claims 38-40, wherein the ECG sensor is provided by:
a. an RF electrode;
b. an electrode independent of the RF electrode;
c. a second operational head of the therapeutic device; or
d. a second therapeutic device.
42. The system of any of Claims 25-37, wherein the one or more sensors comprise a fiberoptic lumen contained within the therapeutic head.
43. The system of Claim 42, wherein the fiber-optic lumen conveys spectral information from which the chemical composition of ablation products can be monitored.
44. The system of Claim 43, wherein the control instructions specify any of:
a. the spectrum of said ablation products;
b. parameters or algorithms by which this the spectrum is used to control energy output.
45. The system of any of Claims 25-44, wherein the one or more sensors comprise a force sensor.
46. The system of Claim 45, wherein force sensor is active in one or more axes and is
configured to measure the application force of one or more RF electrodes against the target site.
47. The system of Claim 45 or Claim 46, wherein the control instructions comprise one or more parameters selected from:
a. force;
b. frequency response;
c. time parameters which indicate proper/improper contact pressure;
d. physiological pressure, optionally wherein the physiological pressure is blood pressure;
e. physiological pressure resulting from motion, optionally the physiological
pressure is a pressure resulting from cardiac contraction or respiration.
48. The system of Claim 12, wherein the system comprises a user interface comprising a display and a user input device, and wherein the control instructions comprise:
a. a workflow comprising a plurality of procedure progression states of a
therapeutic procedure;
b. the order of the states;
c. data to be presented on the user output device for each state;
d. data to be entered via the user input device or sensed for each state;
e. value of user input or sensed parameter that activates the next state;
49. The system of Claim 48, wherein the states comprises:
a. a standby state, wherein the standby stage optionally provides a prompt using the user output device, wherein the prompt is a prompt to connect the therapeutic device or operational head thereof;
b. a programing state, wherein the programming state is configured to allow input of treatment parameters, patient information, or user-interface preferences through a user input device;
c. a ready state, optionally wherein the ready state is configured to wait for a user input or a sensed condition to initiate treatment;
d. a treatment state, optionally wherein the treatment state is configured to deliver energy output according an algorithm specified by the control instructions;
e. an warning state, optionally wherein the warning state is configured to continue energy output continues, but is approaching an alarm condition, wherein the alarm condition is detected based on input from one or more sensors or parameters of energy output; f. an alarm state, optionally wherein the alarm state is configured to discontinue energy output when the alarm condition is detected, and
g. an error state, wherein the error state is configured to indicate a fault with the generator or connected therapeutic device.
50. The system of any of the preceding claims, wherein the reversible connector comprises the reversible memory operable linkage.
51. The system of Claim 50, wherein the reversible memory operable linkage is an electrical connection.
52. The system of any of the preceding claims, wherein the operational head comprises any of:
a. a mono polar needle;
b. a bipolar needle; and
c. an array of needles.
53. The system of Claim 52, wherein the array of needles is any of:
a. a monopolar array;
b. a bipolar array;
c. operably linked to a plurality of RF generators, wherein the console comprises the plurality of RF generators.
54. The system of Claim 52, wherein array of needles is operably linked to a plurality of RF generators, wherein the therapeutic device is configured for combining bipolar and monopolar energy in a phased array.
55. The system of any of the preceding claims, wherein the operational head comprises a balloon device containing one or more energy output electrodes on its surface.
56. The system of any of the preceding claims, wherein the operational head comprises a mesh or basket which expands to contact the physiological tissue.
57. The system of any of the preceding claims, wherein the therapeutic device comprises a lighting device.
58. The system of Claim 57, wherein the therapeutic device comprises an imaging device.
59. The system of Claim 1, wherein:
a. the therapeutic device further comprises a sensor configured for sensing an environmental condition, optionally wherein the environmental condition is a condition of the biological tissue or the organism comprising the biological tissue; b. the reversible connector is further configured for operably linking the sensor to the controller;
c. the control instructions comprise:
i. a target value for the environmental condition; and
ii. optionally, instructions for controlling the RF output such that said target value for the environmental condition is sensed.
60. The system of Claim 59, wherein the environmental condition is a condition of any of: the biological tissue, an organism comprising the biological tissue, the therapeutic device, and the operational head of the therapeutic device.
61. The system of Claim 59 or Claim 60, wherein the environmental condition is any of: a. temperature;
b. impedance;
c. voltage;
d. force;
e. contact pressure;
f. fluid pressure;
g. ECG;
h. fluid flow;
i. EMG;
j. light/optics;
k. sound;
I. chemical composition;
m. cross-conduction between a plurality of channels, wherein the therapeutic device comprises a plurality of channels;
n. fibre-optic imaging within a balloon catheter;
o. a biological effect;
p. instrument damage;
62. The system of Claim 1, wherein the instructions comprise a set of parameters selected from:
a. voltage or current, pulse rate, and pulse duration;
b. temperature, temperature rate of change, and thermal impedance
c. power, temperature, fluid flow rate, and impedance
d. fluid pressure, impedance, thermal impedance, and temperature e. electrode application pressure, thermal impedance, and temperature f. total energy delivered, temperature, and impedance
g. voltage, waveshape, and ECG trigger morphology
63. The system of Claim 1, wherein the therapeutic device comprises a secondary device or the console is connected to the secondary device, and wherein the control instructions are further configured for controlling the secondary device, optionally wherein the secondary device is selected from any of the following types:
a. fluid pump;
b. irrigation;
c. aspiration;
d. lighting;
e. balloon inflation; and
f. RF heating device.
64. The system of Claim 1, wherein the control instructions comprise an algorithm for conducting an RF ablation procedure.
65. The system of Claim 8, wherein the algorithm provides one or more of:
a. Channel to control;
b. Average Power to deliver;
c. Peak Power to deliver;
d. Duration of delivery;
e. Temperature to maintain;
f. Voltage to maintain;
g. Current to maintain;
h. Maximum power to be used to maintain voltage;
i. Maximum power to be used to maintain current;
j. Maximum power to be used to maintain Temperature;
k. Minimum power to be used to maintain Temperature;
I. Maximum number of joules to deliver;
m. Maximum Voltage allowed;
n. Maximum Current allowed;
o. Time to ramp to temperature;
p. Time to ramp to power; q. Profile, or intermediate points on power vs time curve, to be followed while changing power;
r. Profile, or intermediate points on temperature vs time curve, to be followed while changing temperature;
s. Modulation period of RF energy;
t. Modulation duty cycle of RF energy;
u. Frequency of RF energy;
v. Control systems gains, optionally wherein the control systems gains comprise proportional, integral, and derivative gains in temperature and power PID control loops;;
w. Estimates of parameters used to predict the response of the patient or
therapeutic device optionally wherein the response is selected from thermal mass, thermal time constant, and energy lost to blood flow; and
x. one or more triggers.
66. The system of Claim 65, wherein the one or more triggers are configured to cause
control of one or more output devices or adjustment of settings.
67. The system of Claim 66, wherein the one or more triggers are configured to adjust parameters or another trigger.
68. The system of Claim 65, 66, or 67, wherein the algorithm comprises a plurality of states, and the triggers are configured to activate one or more of the plurality of states, optionally wherein the plurality of states are a workflow or cascade of states configured to achieve a therapeutic effect.
69. The system of any of Claims 65-68, wherein the one or more triggers are selected from: a. maximum temperature limit;
b. minimum temperature limit;
c. maximum power limit;
d. minimum power limit;
e. maximum impedance limit;
f. minimum impedance limit;
g. temperature change;
h. power change;
i. impedance change;
j. Expiration of time; k. Rate of change of temperature;
I. Rate of change of impedance;
m. Rate of change of power ;
n. Activation of an RF power activation switch;
o. Activation of an RF power activation footswitch;
p. Activation of an RF power activation hand switch;
q. ECG feature;
r. ECG rhythm;
s. ECG rate;
t. Respiration Rate;
u. Change in thermal time constant or thermal impedance;
v. Change in losses due to blood flow;
w. Change in fluid flow;
x. Change in fluid pressure;
y. Change in force sensor pressure;
z. Changes in optically detected analytes which indicate physiological change in target tissue.
70. The system of Claim 1, wherein the memory device is proximal to the reversible
connector, optionally wherein the memory device and the operable linkage share a common housing.
71. The system of any of Claims 2-69, wherein the memory device is proximal to the
reversible connector, optionally wherein the memory device and the operable linkage share a common housing.
72. The system of any of the preceding claims, wherein the energy generator comprises an RF generator, an ultrasound generator, a microwave generator, or a laser generator.
100. A system comprising: a. a first console comprising a first energy generator and a first controller configured for controlling the energy output of the first energy generator ('first energy output'), optionally wherein the first energy output comprises therapeutic energy; b. a first therapeutic device comprising: I. an operational head comprising a first energy delivery head configured for transmitting the first energy output to a target site; and
II. a first memory device comprising control instructions for said controlling the first energy output;
c. a first reversible connector configured for operably linking the first energy generator to the first energy delivery head;
d. a first reversible memory operable linkage configured for operably linking the first memory device to the first controller; and
e. an electronic device comprising an input or output device ('I/O device)
configured for providing a function other than said transmitting the first energy output to the target site ('secondary device'), wherein:
i. the secondary device is operably linked to the first controller; and ii. optionally, the system comprises control instructions for controlling the secondary device on a memory device that is reversibly linked to the first controller.
101. The system of Claim 100, wherein:
a. the first memory device comprises the control instructions for controlling the secondary device; or
b. the secondary device comprises a second memory device comprising the control instructions for controlling the secondary device, optionally wherein the second memory device is reversibly linked to the first controller.
102. The system of Claim 100 or Claim 101, wherein the secondary device comprises a second energy generator, an intermediate device, or a user interface ('Ul').
103. The system of Claim 102, wherein the secondary device comprises a second energy generator, wherein the second energy generator is a generator of a diagnostic energy or therapeutic energy.
104. The system of Claim 103, wherein the second energy generator is a generator of therapeutic energy.
105. The system of Claim 104, wherein the therapeutic energy is selected from
electromagnetic energy, mechanical energy, thermal energy, and electrical energy.
106. The system of Claim 105, wherein the therapeutic energy is electromagnetic energy selected from RF energy, microwave energy, and laser energy.
107. The system of Claim 105, wherein the therapeutic energy is mechanical energy selected from sonic energy, irrigation, and pneumatic pressure.
108. The system of Claim 104, wherein the therapeutic energy is selected from
ablation energy, cutting energy, and thermal energy.
109. The system of Claim 108, wherein the therapeutic energy is selected from RF energy, sonic energy, microwave energy, laser energy, cryoablation energy, plasma energy, electroporation energy, and high intensity focused ultrasound (H IFU) energy.
110. The system of Claim 103, wherein the second energy generator is a generator of diagnostic energy.
111. The system of Claim 110, wherein the diagnostic energy is imaging energy.
112. The system of Claim 111, wherein the imaging energy is electromagnetic imaging energy, RF imaging energy, X-ray imaging energy, or magnetic energy.
113. The system of Claim 112, wherein the secondary device is selected from an MRI device, an X-ray device, a CAT device, a PET device, and a fluoroscopy device.
114. The system of Claim 103, wherein the energy generator is an electromagnetic energy generator or a sonic energy generator.
115A. The system of Claim 102, wherein the secondary device comprises a U l comprising a display, a speaker, or both.
115B. The system of Claim 115A, wherein the instructions for controlling the secondary device comprise instructions to provide the user with feedback, optionally wherein the feedback is selected from: feedback from a temperature sensor, connection status of the therapeutic device, authenticity of the therapeutic device, and use data of the therapeutic device.
115C The system of Claim 115A, wherein the instructions for controlling the secondary device comprise labels, screens, fields, or workflows.
115D. The system of any of Claims 115A to 115C, wherein the instructions for controlling the secondary device are provided on the first memory device. . The system of Claim 100 or 101, wherein:
a. the secondary device comprises a second controller configured for controlling the I/O device and wherein said operable linkage of the secondary device to the first controller comprises a data link connecting the first controller and the second controller, optionally wherein said data link comprises a second reversible connector; or
b. the I/O device is configured for control by the first controller, wherein said
operable linkage of the secondary device to the first controller comprises an operable linkage between the first controller and the I/O device, optionally wherein said operable linkage between the first controller and the I/O device comprises a second reversible connector.
117. The system of Claim 116, wherein the I/O device is an analog device or a digital device.
118. The system of Claim 100, 101, or 116, wherein the I/O device is a device that provides a therapeutic or diagnostic function fd/t device').
119. The system of Claim 118, wherein the d/t device is a diagnostic device.
120. The system of Claim 119, wherein the diagnostic device comprises a device selected from a sensor and an imaging device
121. The system of Claim 120, wherein the diagnostic device comprises a sensor selected from: a temperature sensor, a force sensor, a heart rate sensor, an ECG sensor, an EEG sensor, an EMG sensor, an EOG sensor, and a respiration sensor.
122A. The system of Claim 120, wherein:
a. the first energy output comprises a therapeutic energy; and
b. the diagnostic device comprises a sensor of a biological effect of the therapeutic energy.
122B. The system of Claim 120, wherein the diagnostic device comprises an imaging device and the first energy generator is a generator of heating, freezing, cutting, or ablation energy.
122C. The system of Claim 122B, wherein the first energy generator is a generator of an energy selected from RF energy, sonic energy, microwave energy, and laser energy, cryoablation energy, plasma energy, electroporation energy, and high intensity focused ultrasound (H IFU) energy.
122D. The system of any of Claims 122B or Claim 122C, wherein the first memory device comprises parameters of the first energy delivery head.
122E. The system of Claim 122D, wherein said parameters of the first energy delivery head comprise length, area, mass, orientation, volume, opacity, or antenna coupling coefficient of the first energy delivery head, optionally wherein said parameters of the first energy delivery head are parameters of one or more energy delivery electrodes.
122F. The system of Claim 122D or 122E, wherein the system is configured for:
a. obtaining the parameters of the first energy delivery head;
b. obtaining imaging feedback from imaging device; and
c. correlating or modifying the imaging feedback based on one or more of said parameters of the first energy delivery head, and optionally presenting said feedback on a display, optionally wherein said feedback or presentation on a display comprises a calculation selected from lesion size, lesion shape, lesion position, amount of energy absorption by a tissue, and effect of a combination of energy from multiple electrodes.
122G. The system of Claim 122D, wherein the parameters of the first energy delivery head comprise one or more of size, distance, surface area, impedance, calibration and correction factors, coupling factors, frequency-specific characterizations, resonant frequency, and opacity.
122H. The system of any of Claims 122B or 122G, wherein the system is configured for transmitting imaging feedback from the imaging device to the first controller, optionally wherein the imaging feedback comprises spatial or tissue characterization information. 1221. The system of Claim 122H, wherein the first controller is configured to modulate the energy output or select or modify algorithms for energy output based on the transmitted imaging feedback.
122J. The system of Claim 122D, wherein the first controller is configured for obtaining the parameters of the first energy delivery head and modifying or selecting treatment algorithms stored on the first memory device or a console memory device.
123. The system of Claim 120, wherein the diagnostic device comprises an imaging device configured for imaging the first energy delivery head.
124. The system of Claim 118, wherein the d/t device is a device that provides a therapeutic function.
125. The system of Claim 124, wherein the d/t device comprises a device selected from: a therapeutic energy generator, a fluid pump, a vaporizer, and a ventilator.
126. The system of Claim 116, wherein:
a. the secondary device comprises: i. a second console comprising a second energy generator and a second controller configured for controlling the energy output of the second energy generator ('second energy output'), optionally wherein the second energy output comprises therapeutic energy;
ii. a second therapeutic device comprising:
1. a second energy delivery head configured for transmitting the second energy output to a target site; and
2. a second memory device comprising control instructions for said controlling the second energy output;
iii. a second reversible connector configured for operably linking the second energy generator to the second energy delivery head; and
iv. a second reversible memory operable linkage configured for operably linking the second memory device to the second controller; and b. the system comprises a data link connecting the first controller and the second controller.
127. The system of Claim 126, wherein the first energy generator and the second energy generator are any of the following combinations:
a. an ablation energy generator and an imaging energy generator;
b. an ablation energy generator and a fluid pump;
c. a ventilator and a vaporizer;
d. a therapeutic energy generator and an imaging energy generator; and e. a first therapeutic energy generator and a second therapeutic energy generator.
128. The system of Claim 126 or Claim 127, wherein: the first energy delivery head and the second energy delivery head are each configured to deliver therapy to the same target site.
129. The system of Claim 128, wherein:
a. the first energy generator is a ventilator;
b. the second energy generator is a vaporizer; and
c. one of the first and second energy delivery heads comprise a patient tube circuit or a facemask, and the other comprises an inlet to said patient tube circuit or facemask.
130. The system of Claim 128, wherein
a. the first energy generator is an ablation energy generator; b. the second energy generator is a fluid pump; and
c. the first energy delivery head comprises a catheter comprising an ablation
electrode on the catheter tip and the second energy delivery head comprises a cannula in the catheter configured transmit fluid between the fluid pump at the catheter tip.
131. The system of Claim 130, wherein said second energy delivery head is an open loop or closed loop irrigation head.
132. The system of any of Claims 127, 128, 130, or 131, wherein the system
comprises a fluid reservoir connected to the fluid pump.
133. The system of Claim 102, wherein:
a. the secondary device is an intermediate device configured for transmitting the first energy output from the console to the therapeutic device;
b. the first reversible connector is configured for coupling the therapeutic device to the intermediate device;
c. the system comprises a second reversible connector configured for coupling the intermediate device to the console.
134. The system of Claim 133, wherein the therapeutic device comprises a sensor and the intermediate device is configured for opera bly linking the sensor to the console.
135. The system of Claim 133 or Claim 134, wherein the intermediate device
comprises a second memory device.
136. The system of Claim 135, wherein the second memory device comprises
instructions for controlling the first energy generator.
137. The system of Claim 136, wherein the second memory device comprises
calibration parameters of the intermediate device or capability parameters of the intermediate device.
138. The system of Claim 137, wherein said parameters of the intermediate device comprise capabilities, impedance, loss factors, or frequency characterization.
139. The system of Claim 136, wherein the second memory device comprises one or more instructions selected from:
a. compatible or incompatible modes of operation for the intermediate device; b. compatible or incompatible therapeutic devices;
c. compatible or incompatible consoles;
d. use data of the intermediate device; e. recommend number of uses of the intermediate device;
f. authentication of the intermediate device;
g. re-use prevention rules of the intermediate device;; and
h. sterilization validity information of the intermediate device.
140. The system of Claim 136, wherein the second memory device comprises a
software update for the first controller.
141. The system of Claim 133, wherein the intermediate device comprises an
extension configured for coupling the energy generator to the first energy delivery head, optionally wherein the extension has a length of greater than any of: 30 cm, 60 cm, 90 cm, and 120 cm.
142. The system of any of Claims 133-141, wherein the first memory device
comprises parameters of the therapeutic device selected from calibration parameters of the therapeutic device and capability parameters of the therapeutic device.
143. The system of Claim 142, wherein said parameters of the therapeutic device comprise capabilities, impedance, loss factors, or frequency characterization.
144. The system of any of Claims 133-141, wherein the first memory device
comprises one or more instructions selected from:
a. compatible or incompatible modes of operation for the therapeutic device; b. compatible or incompatible intermediate devices;
c. compatible or incompatible consoles;
d. use data of the therapeutic device.
e. recommend number of uses of the therapeutic device;
f. authentication of the therapeutic device;
g. re-use prevention rules of the therapeutic device; and
h. sterilization validity information of the therapeutic device.
145. The system of any of Claims 133-141, wherein the first memory device
comprises a software update for the first controller.
146. The system of any of the preceding claims, wherein:
a. the therapeutic device comprises an ID code and control instructions associated with said ID code are provided or either:
i. a second memory device comprised by the secondary device; or ii. a memory device local to the console; or b. the secondary device comprises an ID code and control instructions associated with said ID code are provided or either:
i. the first memory device; or
ii. a memory device local to the console.
147. The system of any of Claims 100-146, wherein the first energy delivery head comprises any of: an RF ablator, RF catheter, a tissue ablator, and a nerve ablator.
148. The system of any of Claims 100-146, wherein the first reversible connector comprises a pair of interacting couplers comprising a therapeutic device-side connector and a console-side connector.
149. The system of Claim 148, wherein the therapeutic device-side connector
comprises the first memory device.
150. The system of Claim 149, wherein the first memory device is provided in or on the therapeutic device-side connector.
151. The system of Claim 149, wherein the first reversible memory operable linkage is a wired linkage connected to the console through the first reversible connector.
152. The system of Claim 149, wherein the first reversible memory operable linkage is a wireless linkage.
153. The system of any of Claims 100-152, wherein the therapeutic device comprises a sensor.
154. The system of Claim 153, wherein he first reversible connector comprises
operable linkage for connecting the sensor to the controller ('sensor linkage').
155. The system of Claim 153 or Claim 155, wherein the sensor is selected from a temperature sensor, a force sensor, a sensor of an environmental condition; and a sensor of a biological effect of the first energy generator.
156. The system of any of Claims 100-152, wherein the control instructions for said controlling the first energy output comprise instructions for delivering a therapeutic energy profile.
157. The system of Claim 156, wherein the instructions for delivering a therapeutic energy profile comprise an algorithm, a set of parameters, or both.
158. The system of claim 157, wherein the instructions for delivering a therapeutic energy profile specify one or more parameters of energy output selected frequency, amplitude, crest factor, pulse characteristic, or any combination of three or four of said parameters.
159. The system of any of Claims 100-152, wherein the first memory device or controller is further programmed to modify the therapeutic profile (e.g. starting, stopping, or changing energy delivery based on the monitored parameters) based upon feedback, e.g. of connection status, temperature, authenticity of manufacturer and reuse/obsolescence.
160. The system of any of Claims 100-152, wherein the system comprises instructions for obtaining feedback from the therapeutic device or the secondary device and modulating the first energy output based on said feedback, optionally wherein said instructions for modulating energy output are provided by the first memory device, a memory device local to the first controller, or a second memory device reversibly linked to the first console controller.
161. The system of Claim 160, wherein said modulating the first energy output
comprises initiating energy output, terminating energy output, or modifying parameters of energy output.
162. The system of Claim 160 or Claim 161, wherein said feedback comprises one or more feedback parameters selected from a monitored parameter, a sensed parameter, a calculated parameter, or a parameter stored on the first memory device or the optional second memory device.
163. The system of Claim 162, wherein the monitored parameter comprises
connection status of the therapeutic device or the secondary device.
164. The system of Claim 162, wherein the sensed parameter comprises temperature or force.
165. The system of Claim 162, wherein the stored parameter comprises authenticity or use data.
166. The system of any of Claims 100-152, wherein the first console comprises a connection to a user input device, a data network, or both.
167. The system of any of Claims 100-152, wherein the system comprises a memory device comprising instructions for uploading data to a remote server over a computer network, optionally wherein the memory device comprising instructions for uploading is the first memory device or a console memory device.
168. The system of Claim 167, wherein the uploaded data comprises therapeutic device use data, procedure data, performance data, or a procedure log.
169. The system of any of Claims 100-152, wherein the system comprises a memory device comprising instructions for recording data to the first memory device, optionally wherein the memory device comprising instructions for recording data is the first memory device or a console memory device.
170. The system of Claim 169, wherein the recorded data comprises therapeutic device use data, procedure data, performance data, or a procedure log.
171. The system of any of Claims 100-152, wherein the first energy delivery head is comingled with one or more of a sensor or an irrigation head.
172. The system of Claim 171, wherein said comingled first energy delivery head and sensor or irrigation head comprises a catheter comprising energy delivery electrodes and a cannula for irrigation, a sensor or both.
173. The system of Claim 171 or Claim 172, wherein the sensor is reversibly linked to the first controller through the first reversible connector.
174. The system of Claim 105, wherein the therapeutic energy is mechanical energy.
175. The system of Claim 174, wherein the second energy generator is a fluid pump and the secondary device is an irrigation device comprising the fluid pump and an irrigation head.
176. The system of Claim 175, wherein the secondary device comprises a second memory device comprising parameters of the fluid pump, optionally wherein the second memory device is reversibly linked to the first controller.
177. The system of Claim 176, wherein the parameters of the fluid pump comprise specifications of the fluid pump.
178. The system of Claim 177, wherein the first memory device or a console memory device comprises instructions for obtaining the parameters of the fluid pump and controlling the fluid pump to provide a therapeutic profile.
179. The system of any of Claims 175-178, wherein the first energy generator is a therapeutic energy generator selected from a generator of ablation energy, a generator of electromagnetic energy, and a generation of sonic energy.
180. The system of any of the preceding claims, wherein: the first memory device comprises at least one instruction for controlling the secondary device.
181. The system of any of Claims 100-179, wherein:
a. the secondary device comprises a second memory device reversibly linked to the first controller; b. the second memory device comprises at least one instruction for controlling the therapeutic device.
182. The system of any of Claims 100-179, wherein the system is configured to: a. identify the secondary device from a plurality of alternatively connected
secondary devices or identify the combination of the first therapeutic device and the secondary device from a plurality of combinations; and
b. the first memory device comprises a plurality of sets of control instructions, wherein each set is specific to one said alternatively connected secondary devices or combinations.
183. The system of any of Claims 100-179, wherein the therapeutic device or the secondary device comprises:
a. a ventilator or an energy delivery head connected thereto; and
b. optionally a pressure sensor;
184. The system of Claim 183, wherein the system comprises instructions for
receiving feedback from the pressure sensor controlling the ventilator to obtain a target pressure, optionally wherein said instructions are provided on the first memory device or on a console memory device.
185. The system of Claim 183 or Claim 184, wherein:
a. said therapeutic device or secondary device is a therapeutic device and the second memory device comprises parameters or algorithms for controlling the ventilator which are suitable for the first energy delivery head of the therapeutic device; or
b. said therapeutic device or secondary device is a secondary device, and the
secondary device comprises a memory device reversibly linked to the first controller comprising parameters or algorithms for controlling the ventilator which are suitable for the secondary device.
186. The system of Claim 185, wherein the parameters or algorithms for controlling the ventilator comprise treatment parameters or calibration parameters of the ventilator or energy delivery head connected thereto.
187. The system of Claim 186, wherein the calibration parameters comprise one or more of tube resistance, pressure sensor calibration, and sterilization data.
188. The system of any of Claims 185-187, wherein:
a. said therapeutic device or secondary device is the therapeutic device; b. the first controller is a ventilator controller; and
c. the first memory device comprises a software update for the ventilator
controller.
189. The system of any of the preceding claims, wherein the system comprises at least two memory devices, wherein the console comprises software configured to obtain data from two or more of memory devices of the system, and provide a set of control instructions for a therapeutic procedure using less than all of said data ('configuration management software'), optionally wherein said connected memory devices comprise one or more reversibly connected memory devices comprised by respective therapeutic devices or secondary devices.
190. The system of Claim 189, wherein the configuration management software is configured for interpreting and/or implementing said data from the one or more of the reversibly connected memory devices.
191. The system of Claim 190, wherein configuration management software is
configured for obtaining instructions from at least two memory devices, wherein at least one of said memory devices is a reversibly connected memory device of a therapeutic device or a secondary device.
192. The system of Claim 191, wherein:
a. said data from at least two memory devices comprise a set of control
instructions from at least two of the at least two memory devices; b. the configuration management software is configured for conflict resolution between the at least two sets of control instructions.
193. The system of Claim 192, wherein the configuration management software is configured to:
a. identify an inconsistent or incoherent combination of the at least two sets of control instructions; and
b. provide a set of control instructions for a therapeutic procedure
194. The system of Claim 193, wherein the step of providing a set of control
instructions for a therapeutic procedure comprises:
a. selecting a set of control instructions from the at least two sets of control instructions; or
b. selecting portions from the at least two sets of control instructions.
195. The system of Claim 193 or Claim 194, wherein said inconsistent or incoherent combination comprises inconsistent or incoherent parameters.
196. The system of Claim 195, wherein said inconsistent or incoherent parameters comprise a target temperature provided by a first set of control instructions that is different from a target temperature provided by a second set of control instructions.
197. The system of any of Claims 193-196, wherein the configuration management software is configured to perform steps of:
a. obtaining data from the at least two memory devices;
b. making a determination of the most-appropriate combination of software, parameters, or algorithms to use for a therapeutic procedure.
198. The system of any of Claims 193-195, wherein the inconsistent or incoherent combination comprises at least one of:
a. control instructions provided on two respective memory devices, each
containing a software update for one or more consoles which are different from the other;
b. control instructions provided on two respective two memory devices, each containing settings or algorithms which are different from the other; c. first control instructions provided on a reversibly connected memory device which contain settings for a device, and a console memory device which also contains second control instructions comprising settings for said device which are different than the settings of the first control instructions;
d. first control instructions provided on a reversibly connected memory device contains a first software version for the console, and a console memory device which contains a second software version for the console, wherein the second software version is a more recent version than the first software version;
e. control instructions provided on a reversibly connected memory device
comprising a first software version for the console, and control instructions provided on another memory device which comprise a second software version for the console, wherein the first software version is different than the second software version;
f. control instructions provided on a reversibly connected memory device which specify use with an compatible connected device or console, wherein the system comprises a connected device or console other than said an compatible connected device or console;
g. control instructions provided on a memory device that contains a list of one or more compatible therapeutic devices, sensory devices, or console, wherein said system includes a therapeutic device, sensory device, or console that is not provided in the list;
h. control instructions provided on a memory device that contains a list of one or more incompatible therapeutic devices, sensory devices, or console, wherein said system includes a therapeutic device, sensory device, or console that is provided in the list;
i. control instructions provided by respective memory devices that comprise non- redundant control instructions or parameter.
j. control instructions provided by respective memory devices, wherein at least one of the sets of control instructions comprises less than a full set of instructions required to perform a therapeutic procedure
k. control instructions provided by respective memory devices, wherein at least one of the control instructions reference a console, therapeutic device, or secondary device which is not connected to the system.
199. The system of any of Claims 193-198, wherein the configuration management software is configured to obtain one or more business rules or clinical rules from at least one memory device.
200. The system of Claim 199, wherein the one or more business rules or clinical rules comprise any of:
a. an identification of combinations of other devices are compatible with a
particular device;
b. an identification of which software is compatible with device combinations; c. instructions for selecting a software version from one of the memory devices d. instructions to downgrade console software or to utilize newer software
provided by a reversibly connected memory device when a console's memory device contains more-recent software or information than that specified by any currently connected reversibly connected memory device;
e. an override rule, optionally wherein said override rules an override configured to run when instructions on a reversibly connected memory device indicate that its respective therapeutic device or secondary device has use limits, optionally wherein the override rule specifies whether treatment can proceed if a device has met or exceeded its use or re-use limit
f. an error-processing rule, optionally wherein the error-processing rule specifies if treatment can initiate when memory is not present in a reversibly connected device, or the memory cannot be read;
g. a data-write rule, optionally wherein the data-write rule specifies which memory device, should be written with data or feedback from the current therapeutic procedure and
h. a display rule, optionally wherein the display rule specifies the information that is displayed to the user for a given combination of devices.
201. The system of any of the preceding claims, wherein the memory device of the therapeutic device or the first therapeutic device comprises one or more parameters corresponding to said therapeutic device or first therapeutic device, wherein the one or more parameters are selected from calibration parameters, capability parameters, or verification parameters, optionally wherein the parameters are selected from the 'Parameter List' in Example 23.
202. The system of any of the preceding claims, wherein the memory device of the therapeutic device or the first therapeutic device comprises one or more parameters of energy output of a first energy generator and one or more parameters of energy output of a second energy generator, optionally, wherein the system comprise both the first and second energy generators .
203. The system of claim 202, wherein the parameters of energy output are selected from the 'Parameter List' in Example 23.
204. The system of any of the preceding claims, wherein the memory device of the therapeutic device or the first therapeutic device comprises one or more parameters of Ul output, optionally wherein the parameters of Ul output are selected from the 'Parameter List' in Example 23.
205. The system of any of the preceding claims, wherein the memory device of the therapeutic device or the first therapeutic device comprises one or more input parameters, optionally wherein the input parameters are selected from the 'Parameter List' in Example 23.
PCT/US2013/056072 2012-08-22 2013-08-22 Therapeutic energy systems WO2014031800A1 (en)

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