(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2005/0216062 A1
`(43) Pub. Date:
`Sep. 29, 2005
`Herbst
`
`US 20050216062A1
`
`(54) MULTI-FUNCTIONAL ELECTRICAL
`STIMULATION SYSTEM
`(76) Inventor: Ewa Herbst, Edgewater, NJ (US)
`Correspondence Address:
`WILMER CUTLER PICKERING HALE AND
`DORR LLP
`399 PARKAVENUE
`NEW YORK, NY 10022 (US)
`(21) Appl. No.:
`10/706,844
`(22) Filed:
`Nov. 12, 2003
`Related U.S. Application Data
`(63) Continuation of application No. 09/507,873, filed on
`Feb. 22, 2000, now Pat. No. 6,684,106, which is a
`continuation of application No. 09/013,049, filed on
`Jan. 27, 1998, now Pat. No. 6,029,090.
`(60) Provisional application No. 60/034.869, filed on Jan.
`27, 1997.
`
`Publication Classification
`
`(51) Int. Cl. .................................................... A61N 1100
`(52) U.S. Cl. .................................................................. 607/2
`(57)
`ABSTRACT
`A multi-functional electrical Stimulation (ES) system
`adapted to yield output signals for effecting faradic, elec
`tromagnetic, or other forms of electrical Stimulation for a
`broad spectrum of different biological and biomedical appli
`cations. The System includes and ES Signal Stage having a
`Selector coupled to a plurality of different Signal generators,
`each generator producing a signal having a distinct shape
`Such as a Sine, a Square or Sawtooth wave or a simple or
`
`complex pulse form, the parameters of which are adjustable
`in regard to amplitude, duration, repetition rate and other
`variables. The signal from the selected generator in the ES
`Stage is fed to at least one output stage where it is processed
`to produce a high or low voltage or current output of a
`desired polarity whereby the output stage is capable of
`yielding an electrical Stimulation Signal appropriate for its
`intended application. Also included in the System is a
`measuring Stage which measures and displays the electrical
`Stimulation Signal operating on the Substance being treated
`as well as the outputs of various Sensors which Sense
`conditions prevailing in this Substance whereby the user of
`the System can adjust it to yield an electrical Stimulation
`Signal of whatever type he wishes and can then observe the
`effects of this signal on a Substance being treated.
`A multi-functional electrical Stimulation (ES) system
`adapted to yield output signals for effecting faradic, elec
`tromagnetic, or other forms of electrical Stimulation for a
`broad spectrum of different biological and biomedical appli
`cations. The System includes and ES Signal Stage having a
`Selector coupled to a plurality of different Signal generators,
`each generator producing a signal having a distinct shape
`Such as a Sine, a Square or Sawtooth wave or a simple or
`complex pulse form, the parameters of which are adjustable
`in regard to amplitude, duration, repetition rate and other
`variables. The signal from the selected generator in the ES
`Stage is fed to at least one output stage where it is processed
`to produce a high or low voltage or current output of a
`desired polarity whereby the output stage is capable of
`yielding an electrical Stimulation Signal appropriate for its
`intended application. Also included in the System is a
`measuring Stage which measures and displays the electrical
`Stimulation Signal operating on the Substance being treated
`as well as the outputs of various Sensors which Sense
`conditions prevailing in this Substance whereby the user of
`the System can adjust it to yield an electrical Stimulation
`Signal of whatever type he wishes and can then observe the
`effects of this signal on a Substance being treated.
`
`ES Signal Stage
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`Patent Application Publication Sep. 29,2005 Sheet 1 of 7
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`Patent Application Publication Sep. 29, 2005 Sheet 2 of 7
`FIG 2
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`US 2005/0216062 A1
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`Pulse Generator
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`31
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`# of Outputs
`
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`Patent Application Publication Sep. 29, 2005 Sheet 3 of 7
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`US 2005/0216062 A1
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`FIG. 4A
`
`Full Power Response
`Rising Edge
`
`CH2 Rise =336ns
`CH2 Fall =Nol Edge
`
`FIG. 4B
`
`
`
`Full Power Response
`Falling Edge
`
`CH2 Rise =No Edge
`CH2 Fall =360ns
`
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`Patent Application Publication Sep. 29, 2005 Sheet 4 of 7
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`Patent Application Publication Sep. 29, 2005 Sheet 5 of 7
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`Patent Application Publication Sep. 29, 2005 Sheet 6 of 7
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`Patent Application Publication Sep. 29,2005 Sheet 7 of 7
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`US 2005/0216062 A1
`
`Sep. 29, 2005
`
`MULTI-FUNCTIONAL ELECTRICAL
`STIMULATION SYSTEM
`0001. This application is a continuation of application
`Ser. No. 013,049, filed Jan. 27, 1998, the disclosure and
`drawings of which are incorporated herein by reference.
`
`RELATED APPLICATIONS
`0002 This application is related to our provisional appli
`cation Ser. No. 60/034,869, filed on Jan. 27, 1997, entitled
`“ELECTRICAL STIMULATOR AND AMPLIFIER", the
`entire disclosure of which is incorporated herein by refer
`CCC.
`
`BACKGROUND OF INVENTION
`0003) 1. Field of Invention
`0004. This invention relates generally to the electrical
`Stimulation devices for effecting faradic, electromagnetic or
`other forms of electrical Stimulation, and more particularly,
`to a multi-functional System for this purpose capable of
`Selectively yielding electrical Stimulation signals for a broad
`Spectrum of different biological and biomedical applications
`as well as for other applications, Such as electrophoresis.
`0005 2. Status of Prior Art
`0006 Electrical stimulation (ES) is widely used in bio
`logical and biomedical research as well as in diagnostics and
`in clinical treatment. In faradic Stimulation a continuously
`intermittent or a continuous direct or alternating current or
`Voltage is produced, whereas in electromagnetic Stimulation,
`a current passing through a coil produces an electromagnetic
`field whose pattern depends on the wave form of the current.
`0007 Electrical stimulation is employed to effect nerve
`regeneration, in neuromuscular research, in medical diag
`nosis and treatment, and in pulsed Voltage electrophoresis.
`Such Stimulation is also used in bone healing and in wound
`healing, as well as in pain relief by means of transcutaneous
`electrical nerve stimulation (TENS). The use of ES to effect
`nerve regeneration is disclosed in the Zanakis et al. U.S. Pat.
`No. 4,774,967 as well as in the Borgens patent U.S. Pat. No.
`4,919,140.
`0008 Researchers in the biological and medical sciences,
`physiotherapists, and clinicians who make use of ES require
`electrical Stimulators of a type Suitable for the activities in
`which they are engaged. Thus neurological investigators
`who seek to non-invasively Stimulate deep nerves make use
`of commercially available magnetic Stimulators which pro
`duce a high-intensity magnetic field pulse for this purpose.
`0009. Also commercially available are constant current
`Stimulators for direct cortical Stimulation as well as electri
`cal Stimulators for nerve and muscle Stimulation procedures
`which generate Single or double pulses, or trains of Such
`pulses. And commercially available are wave generators
`capable of Selectively generating Sine and Square wave
`pulses Suitable for other types of electrical Stimulation.
`0010) But what is not available to researchers and others
`who make use of electrical Stimulation is a multi-functional
`System capable of yielding an electrical Stimulation signal
`that is appropriate for whatever biological or biomedical
`application is the concern of the user of the System.
`
`0011 Let us assume, by way of example, that a
`researcher is engaged in a neurological research program in
`the course of which it becomes necessary to conduct tests on
`the effects of many different types of electrical stimuli on a
`certain set of nerves. The researcher would then have to
`assemble from different commercial Sources the Several
`electrical stimulators of different types called for by this
`program. This burdensome requirement adds Substantially to
`the cost of conducting this research and to its space
`demands.
`0012 While the invention will be described herein as a
`System for producing electrical Stimulating Signals, the
`Signals produced thereby can also be used for electropora
`tion, electrophoresis (preferably pulsed Voltage electro
`phoresis) and iontophoresis as well as for electrochemical
`applications as in the treatment of cancer in which a current
`is passed through the tissue being treated. The Signals can
`also be used to transdermal drug delivery.
`
`SUMMARY OF INVENTION
`0013 In view of the foregoing, the main object of this
`invention is to provide a multi-functional electrical Stimu
`lation (ES) system adapted to yield output signals for
`effecting faradic, electromagnetic or other forms of electri
`cal Stimulation for a broad spectrum of different biological
`and bio-medical applications.
`0014) A significant advantage of a System in accordance
`with the invention is that it affords its user, whether a
`researcher, a diagnostician or a clinician, with whatever
`electrical Stimulation Signal is dictated by the Specific type
`of electrical Stimulation that is required. Thus if in conduct
`ing tests, a researcher needs to Subject certain nerves to
`many different forms of electrical stimulation, the self
`Sufficient System, by itself and without accessories, is
`capable of Supplying whatever electrical Stimulation signals
`are appropriate.
`0015. Also an object of this invention is to provide a
`multi-functional System of the above type that includes a
`measuring Stage that measures and displays the electrical
`Stimulation Signal operating on the Substance being treated
`and also indicates and displayS Signals issuing from Sensors
`which Sense conditions prevailing in the Substance, Such as
`pH and O2, whereby the user of the system is able to observe
`and monitor the effects of the electrical Stimulation Signal he
`has Selected.
`0016. Another object of this invention is to provide a
`highly-compact System of the above type which can be
`manufactured at relatively low cost.
`0017 Briefly stated, these objects are attained by a multi
`functional electrical stimulation (ES) system adapted to
`yield output signals for effecting faradic, electromagnetic or
`other forms of electrical stimulation for a broad spectrum of
`different biological and biomedical applications. The System
`includes an ES Signal Stage having a Selector coupled to a
`plurality of different Signal generators, each producing a
`Signal having a distinct shape Such as a Sine, a Square or
`Sawtooth wave, or Simple or complex pulse, the parameters
`of which are adjustable in regard to amplitude, duration,
`repetition rate and other variables.
`0018. The signal from the selected generator in the ES
`Stage is fed to at least one output stage where it is processed
`
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`US 2005/0216062 A1
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`Sep. 29, 2005
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`to produce a high or low voltage or current output of a
`desired polarity whereby the output stage is capable of
`yielding an electrical Stimulation Signal appropriate for its
`intended application. Also included in the System is a
`measuring Stage which measures and displays the electrical
`Stimulation Signal operating on the Substance being treated
`as well as the outputs of various Sensors which Sense
`conditions prevailing in this Substance whereby the user of
`the System can manually adjust it or have it automatically
`adjusted by feedback to provide an electrical Stimulation
`Signal of whatever type he wishes and the user can then
`observe the effect of this Signal on a Substance being treated.
`0019. In another embodiment of the system, the signals
`from the ES Signal Stage are put on a bus from which they
`can be accessed by the output stages.
`0020. The electrical stimulation signal yielded by the
`System can be used for applications other than those involv
`ing electrical Stimulation, Such as for electrophoresis and
`electroporation. Or the Signals from the System can be used
`in applications requiring mechanical or acoustic waves by
`applying the Signal to an appropriate transducer.
`
`BRIEF DESCRIPTION OF DRAWINGS
`For a better understanding of the invention, as well
`0021
`as other objects and further features thereof, reference is
`made to the following detailed description to be read in
`conjunction with the accompanying drawing, wherein:
`0022 FIG. 1 is a block diagram of a system in accor
`dance with the invention having an ES Stage, an output stage
`and a measuring Stage;
`0023 FIG. 2 is a block diagram of a basic version of a
`System for producing various electrical Stimulation pulses;
`FIG. 3 illustrates an example of a preset custom
`0024
`module,
`FIG. 4A is a graph showing at the full power
`0.025
`output of an amplifier a pulse having a rising edge;
`0.026
`FIG. 4B is a graph showing at the full power
`output of an amplifier a pulse having a falling edge, and
`0027 FIG. 5 (Sections A & B) and FIG. 6 (Sections A &
`B), show an embodiment of a low voltage output stage for
`generating various analog pulses and their combinations
`from digital inputs.
`
`DETAILED DESCRIPTION OF INVENTION
`0028. A system in accordance with the invention, as
`shown in FIG. 1, is composed of an ES signal stage 10
`which at the user's discretion generates a signal shaft
`appropriate for a specific apparatus which is fed to an output
`Stage 11. Output Stage 11 processes the electrical Stimulation
`Signals Selected by the user to yield a types of Signal Suitable
`for its intended biological or biomedical application.
`0029. Also provided is a measuring stage 12 which
`measures and displays the electrical Stimulation Signal oper
`ating on the biological, Substance being Subjected thereto,
`and/or its electrical parameters as well as the output of
`various Sensors which Sense conditions prevailing in this
`Substance whereby the user is able to observe, monitor as
`well as adjust the effects of the Stimulation Signal he has
`Selected on the Substance being treated.
`
`0030 ES signal stage 10 includes signal generators 13 to
`17 producing Signals of different shape. Generator 13 is a
`pulse Wave generator generating one or more rectangular
`pulses, Such as pulses A and B of different width which can
`be outputted Separately or can be added or Subtracted from
`each other to yield A or B, A plus B or Aminus B. Generator
`14 is a Sine wave generator, generator 15 generates a
`triangular or Sawtooth wave, and generator 16 produces a
`ramp Voltage wave. Generator 17 yields a wave of any
`arbitrary shape. The Signal generators are capable of gener
`ating a minimum one pulsatory Signal or a greater numbers
`of pulsatory Signals, or of generating a gated Signal with a
`minimum of one period or a greater number of periods, with
`individual adjustments of electrical parameters.
`0031. By means of a serial input port 18 to ES stage 10
`or a set of parallel input ports 19, the parameters of the
`respective waves produced by Signal generatorS 13 to 17 can
`be adjusted in frequency, pulse width, amplitude and rep
`etition rate, or with respect to any other variable. Coupled to
`generatorS 13 to 17 and activated by a signal applied thereto
`at terminal 20A is a mechanical or electronic Selector Switch
`20. The output Signal from the Signal generator Selected by
`a Switch 20 is applied through a line 21 to output Stage 11.
`In practice, the line is preferably a bus System.
`0032. The ES signal stage 10 is preferably miniaturized
`and may take the form of a hybrid device or a single ASIC
`chip (Application Specific Integrated Circuit). Output stage
`11 includes a mechanical or electronic Selector Switch 22
`which applies the ES signal from stage 10 either to a low
`Voltage processor 23, a high Voltage processor 24, a current
`processor 25, or a power processor 26 to put the ES Signal
`in a form appropriate to the intended application for elec
`trical Stimulation. In-a preferred version, all Signals can be
`accessed simultaneously by one or more output Stages
`through a System bus. In practice, a combination of one or
`more Signal generators in the ES Signal Stage with one or
`more of the output Stag can be miniaturized.
`0033. The output of the processor 23, 24, 25 or 26 chosen
`by selector Switch 22 is fed to a modulator 27 coupled to an
`amplitude control unit 28 which modifies the amplitude of
`the Signal applied thereto. The output of amplitude-control
`unit 28 is applied to a polarity control unit 29 in which the
`electrical Stimulation Signal is given a positive or negative
`polarity or is converted to an AC Signal, depending on the
`intended application for the electrical Stimulation Signal.
`0034). Each output stage can be configured with either
`multiple output terminals 30 or with a single output. The
`multiple outputs make it possible to run Several parallel
`experiments or processes concurrently.
`0035. As previously mentioned, the ES system can be
`miniaturized to form a single ES component comprising
`Signal generators and miniaturized output circuitry packaged
`together. A functional sketch of one Such ES component 31
`is shown in FIG. 2, and an example of a customized module
`32 with a preset waveform and preset electrical parameters
`is shown in FIG. 3.
`0036) A preferred version of the ES component includes
`a Sophisticated digital pulse generator on a chip and an
`analog circuitry to define complex pulse patterns, with
`amplitudes up to +10V. The output can be fed into any
`number of desirable output Stages, which can be integrated
`
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`into the Same component or be independent proprietary
`devices, e.g., voltage controlled or current controlled output
`Stages with various Voltage/current amplitudes, high fre
`quency output Stage with various bandwidths depending on
`a Specific application, various power output Stages, etc.
`Waveforms other than pulse patterns, as well as modulated
`Signals can be part of Such a “system on a chip.’
`0037. The design of a digital ASIC consists of several
`blocks, which can be either used together to create a
`Sophisticated pulse generator for biomedical applications, or
`can be used in any number of other applications requiring a
`pulse Signal. Each of these blockS or functional modules can
`provide an independent waveform or pulse (A pulse; B
`pulse; Square wave; time delay; etc). A basic one output
`version of the Signal generator delivers two independent
`pulses A and B with digitally adjustable pulse widths, the
`Same pulse repetition rate, and with an adjustable delay
`between them or for each of them. It also delivers a Square
`wave and timing for alternate and biphasic pulses and two
`pulse trains. In a two or more output version, individual
`pulses can have independently Set repetition rates.
`0.038. Several of these independent signal generators can
`be combined into a multi-output device. All timing param
`eters of the pulses preferably are fully programmable by a
`user via hardware or via Software-generated inputs. For
`example, one can adjust timing using thumb wheels or
`Switches connected via parallel inputs of the ES component,
`or by using Software and a Serial, parallel, or custom
`interface as an input (or a combination of analog and digital
`inputs can be used). The ES component can include both a
`parallel and a Serial interface So that the user can define the
`optimal means for each application.
`0.039 The analog output amplitudes of the ES component
`or ES System can be adjusted for each pulse separately (via
`hardware or Software, as above). At the same time, a specific
`DC level can be added; i.e., Signal can be shifted up or down
`from Zero line. The alternate and biphasic pulses are
`designed So that only one adjustment for both positive and
`negative pulse width and amplitude is required, which
`results in guaranteed Symmetrical Signals.
`0040. In the circuits shown in FIGS. 5 and 6, the output
`preferably varies from 0 to +10 V and is set digitally. Rise
`time and fall time for a full power response in a Standard
`Speed implementation is 336 ns and 360ns, respectively (see
`FIGS. 4A and 4B). For a 1.0 V pulse response, the corre
`sponding numbers are 186 ns and 163 ns, respectively. The
`ES component can be also interfaced to a current output
`Stage with Single or multiple outputs and current levels of
`t200 uA or another current level depending upon the par
`ticular application of use. In practice an isolated power
`Supply for both analog and digital Signals can be used.
`0041 An optional galvanic isolation can be added
`between the digital and analog parts of the ES component
`using Standard electronic components. This isolation SyS
`tem, in combination with an isolated power Supply for the
`analog signals, provides an isolated output from the Stimu
`lator.
`0042 Pulse Generation:
`0043. This aspect of the invention is a detailed solution
`for generating fast, high accuracy analog pulses with pre
`defined pulse amplitudes, as well as for combining at least
`
`two Single pulses to a pulse pattern. It is one of possible
`Specific Solutions which can be implemented as a part of the
`overall system design. The “Inputs and Outputs' section
`below can be viewed as a design example to show the
`concept behind creating an analog pulse pattern based on at
`least two pulse signals A and B. Each of the A and B pulses
`has a separate Setting of the pulse width and pulse amplitude.
`The same concept is used to create a highly accurate
`biphasic or alternating pulses based on a single amplitude
`Setting for both positive and negative part of the Signal and
`thus eliminating the risk for an unbalanced charge delivered
`to the experimental System.
`0044) Digital pulses A and B have a pulse width TA and
`TB and a delay TD between them generated in hardware (or
`Software) and together with the d-c Voltages preset to the
`desired amplitudes for each pulse signal constitute the input
`Signals to this stage. The design depicted in the "Inputs and
`Outputs' Section uses a Voltage reference and two 12-bit
`DACs on the same chip to set carefully controlled d-c levels.
`The digital pulses A and B are used to control opening and
`closing of a Switch on the output of each of the DACS,
`respectively, and thus shaping A and B pulse waves. The
`correct amplitudes are Set by the DACS and the correct
`analog pulse width is set by the length of time the appro
`priate analog Switch is closed. When the Switch is open, the
`output Voltage for A and B pulse, respectively, is Set to Zero.
`Both waveforms are then passed through an adding circuitry.
`A d-c level can be added at the same time.
`0.045 An optional set of preprogrammed modules, based
`on the architecture of the basic ES component, can be used
`independently or added to the basic ES component or even
`made a part of the ASIC design; for example, a pulse train
`used clinically for bone healing (timing parameters, repeti
`tion rate -15 Hz, pulse train length -5 ms, positive pulse
`with -200 us, negative pulse width -24 us, Electro-Biology,
`Inc. Parsippany, N.J.). This conventional bone-healing Sig
`nal, measured with a pick-up coil, is delivered from an
`electromagnetic field (EMF) stimulator. A preprogrammed
`ES module allows for testing of the biological effects of the
`Same or a similar electrical Signal, but delivered through
`electrodes, without a strong magnetic field component, in
`addition to or instead of both experimental and clinical use
`in EMF stimulators. In situations with multiple parallel
`experiments, the cost of the equipment presently required
`will be significantly reduced by using pulse generator ASIC
`based System of this invention rather than buying Several
`independent Stimulators.
`0046) The flexible pulse generator ASIC and the ES
`component of this invention can form the basis for an ES
`device as described herein, and can be used by electrical
`Stimulation equipment manufacturers as an inexpensive off
`the-shelf component to simplify production, cut costs, Save
`Space, and miniaturize existing Systems. The present inven
`tion improves the overall system reliability by providing the
`whole System as a single well-tested component. The present
`invention using an ASIC reduces the power requirements,
`thus permitting battery operation in applications where high
`current/voltage output is not required, which also allows for
`a further miniaturization of the total digital/analog System
`and adds a Safety feature for clinical applications.
`0047 The following are examples of signal generators
`that can be incorporated in the ES Signal Stage 10, and the
`respective variable timing parameters of these generators:
`
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`I. Pulse Generator
`
`(a) Square pulse
`(b) Single pulse A
`(c) Dual pulses A and B
`
`(d) Alternate pulse
`(e) Biphasic pulse
`
`(f) A + B
`(g) A - B
`
`(h) Pulse train
`
`(i) User defined
`II. Sinewave generator
`III. Sawtooth, triangle.
`
`IV Arbitrary waveform generator
`
`repetition rate (50% duty cycle)
`repetition rate & pulse width
`individually set pulse width
`single output: same repetition rate
`for both A and B dual outputs: same
`or individually set repetition rates
`set automatically by setting pulse A
`parameters
`set automatically setting pulse A
`parameters
`same repetition rate for both
`individual pulse widths
`same repetition rate for both,
`individual pulse widths
`repetition rate of pulse train, and
`either pulse width of the pulse train
`or number of individual pulses in the
`train
`all applicable timing parameters
`frequency
`frequency, rise and fall ramp
`waveform generators times
`all timing parameters
`
`Inputs and Outputs:
`0048)
`0049 Referring now to FIG. 5, (Sections A & B) there
`are two, 2 mm, 40 pin headers from which Signal inputs,
`Signal outputs, and power connect to the printed circuit
`board (pcb). The board requires two Supplies to operate, +15
`VDC and -15 VDC. Power and Ground comes in through
`P2. +5 VDC necessary for logic circuitry and interface is
`derived from onboard regulator U15 from the +15 VDC
`Supply.
`0050 Pulse waveforms are generated within the stimu
`lator by appropriate Switching of 8-to 1 multiplexers U1, U2,
`U17, and U3. Logic level pulses TA, TB, SQ, TA1, and TA2
`are selected by addressing U1 and US with signals WV-A,
`WV-B, and WV-C. U17 and U3 sets pulse polarity and select
`between UA and UB amplitudes.
`
`TABLE 1.
`
`WVA WV-B
`
`WV-C PULSE
`
`AMPLITUDE
`
`O
`O
`O
`O
`
`1.
`
`1.
`
`1.
`
`1.
`
`O
`O
`1.
`1.
`
`O
`
`O
`
`1.
`
`1.
`
`O
`1.
`O
`1.
`
`O
`
`1.
`
`O
`
`1.
`
`Constant “ON”
`TA, “O'”
`TB, “O
`TA, TA2
`
`TA, TA1
`
`TA, TB
`
`TA, TB
`
`SQ, “O'”
`
`Constant UB
`Pulsed TA = UA
`Pulsed TB = UB
`Pulsed TA = UA,
`TA2 = -UA
`Pulsed TA = UA,
`TA1 = -UA
`Pulsed TA = UA,
`TB = -UB
`Pulsed TA = UA,
`TB - UB
`Pulsed SO = UA
`
`0051 U4 and U5 comprise the “logic" which creates the
`waveform and routes the resultant Signal to the output
`amplifiers. When the output of U1 pin 8 is high, Switch 1 of
`U5 is enabled, presenting the level determined by U17 to the
`output amplifiers, This also breaks Switch 2 of U5 which
`prevents contention with the output of U3. The level deter
`mined by U3 pin 8 is presented to the output amplifiers when
`U1 pin 8 is low and U2 pin 8 is high. When U1 pin 8 and
`
`U2 pin 8 are low, corresponding to no pulses, Switch 4 of U5
`is enabled, thereby shorting the input of the output amplifiers
`to ground. This charges or resets the node to 0 VDC.
`0052) Output Amplifiers:
`0053. The dual operation amplifier IC, U9, and associated
`passive components comprise the output amplifiers. Pin 2 of
`U9 is a summing junction. Pulses described above induce
`current through R3 into the inverting node of the first
`amplifier (pin2). If DC level is Set, d-c voltage appearing at
`the junction of R4 and U8 pin 14 induces a d-c current into
`the same inverting junction thereby creating a d-c Voltage
`bias level at the output. If DC-level is not set, R4 is grounded
`through Switch 2 of U8. No d-c bias appears at the output in
`this case. OUT is the output of the first operational amplifier.
`This represents the inverted pulsed signal output train. The
`second amplifier of U9 is also an inverter which provides a
`non-inverted pulse train. Switches 3 and 4 of U8 allow for
`the polarity selection of OUT 2. A logic low selects the
`non-inverting output. A logic high Selects the inverted out
`put. Upon Selecting the inverting output illuminates LED1.
`0054 D-C Level Circuits (FIG. 6):
`0055. A 14 bit multiplying DAC, U6, operational ampli
`fier U7, and associated passive components form the d-c
`level circuit. U6 is a current output DAC configured for
`bipolar output. -The VREF input is determined by the level
`of UA. Since UA ranges from 0 to +10V, the d-c level circuit
`can range from 0 VDC to +10 VDC. The 14-bit DAC bus
`interfaces directly to P1. Three control signals LVLDAC/
`LDAC, LVLDAC/CS, and LVLDACWR allow for address
`ing the DAC and writing levels. Refer to the AD75538 data
`sheet, for more detailed information on this part.
`0056 Dual Programmable Reference:
`0057 Referring now to FIG. 6, U14 is an accurate and
`stable +10,00 volt reference. Resistors R16 through R29
`form a precision resistive divider to derive 6 other Voltage
`levels. U10 and U11 allow for the selection of +10,00V,
`5.000V, 1.000V, 0.3000V, 0.2000V, 0.1000V, 0.010OV or
`ground for the UA and UB channels. Signals UAAO,
`UA A1, UA A2, UB AO, UB A1, and, UB A2 determine
`the UA and UB reference levels respectively.
`
`TABLE 2
`
`UA AO
`
`UA A1
`
`UA A2
`
`LEVEL
`
`O
`O
`O
`O
`1.
`1.
`1.
`1.
`
`O
`O
`1.
`1.
`O
`O
`1.
`1.
`
`O
`1.
`O
`1.
`O
`1.
`O
`1.
`
`1O.OO V
`5.000 V
`1.OOO V
`O3OOO V
`O.2OOO V
`O.1OOO V
`O.O1OO V
`OOOOO V
`
`0058
`
`TABLE 3
`
`UB AO
`
`UB A1
`
`UB U2
`
`LEVEL
`
`O
`O
`
`O
`O
`
`O
`1.
`
`1O.OO V
`5.000 V
`
`LUMENIS EX1007
`Page 12
`
`

`

`US 2005/0216062 A1
`
`Sep. 29, 2005
`
`TABLE 3-continued
`
`UB AO
`
`UB A1
`
`UB U2
`
`LEVEL
`
`0059 A dual op amp, U13, converts the DAC's Achannel
`current output to +UA and -UA voltages. Likewise, U16
`converts the DAC's B channel current output to +UB and
`-UB voltages. U12 is a dual 12-bit multiplying DAC
`arranged for unipolar outputs. U12 shares the same data bus
`per FIGS. 5B & 6B as U6. It is addressed and controlled by
`the SAV /CSA, SAV /CSB, and SAV /WRDAC signals.
`tUA and itUB are used by the waveform generating circuits
`to Set Signal amplitude and polarity. The UA level is also
`used as the reference for the level DAC. Please refer to the
`datasheets for the AD7538, AD7547, ADG408, ADG433,
`AD712,78LO5, and LT1235 components.
`0060) Voltage Output Stage:
`0061 A+10V voltage output is a generic output stage
`useful for Several neuromuscular and other applications.
`This output Stage preferably includes an output amplifier
`Sage Sufficient to drive a load. A +50V Voltage output stage
`can be used in the alternative as a generic output Stage useful
`for Several neuromuscular and other applications. It can be
`limited to a lower voltage than the maximum +50V by
`choosing a lower Voltage power Supply and changing values
`of appropriate components Such as resistors. This higher
`Voltage output Stage is especially useful for the optimization
`of low Voltage electroporation, and it can be packaged