WO2008080073A2 - Système de neuromodulation implantable comprenant un générateur d'impulsions à connexion sans fil et ensemble de rangées d'électrodes - Google Patents

Système de neuromodulation implantable comprenant un générateur d'impulsions à connexion sans fil et ensemble de rangées d'électrodes Download PDF

Info

Publication number
WO2008080073A2
WO2008080073A2 PCT/US2007/088580 US2007088580W WO2008080073A2 WO 2008080073 A2 WO2008080073 A2 WO 2008080073A2 US 2007088580 W US2007088580 W US 2007088580W WO 2008080073 A2 WO2008080073 A2 WO 2008080073A2
Authority
WO
WIPO (PCT)
Prior art keywords
signals
antenna
electrode array
electrodes
power
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2007/088580
Other languages
English (en)
Other versions
WO2008080073A3 (fr
Inventor
Jerry S. Culp
John L Janik
Don Malackowski
Douglas A. Staunton
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Stryker Corp
Original Assignee
Stryker Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Stryker Corp filed Critical Stryker Corp
Publication of WO2008080073A2 publication Critical patent/WO2008080073A2/fr
Publication of WO2008080073A3 publication Critical patent/WO2008080073A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/025—Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36071—Pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37205—Microstimulators, e.g. implantable through a cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223—Circuits for electromagnetic coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A61N1/3787—Electrical supply from an external energy source

Definitions

  • the present invention relates to an implantable system for stimulating neural tissue, especially nerve tissue within the spine. More particularly this invention is related to an implantable system for stimulating tissue that includes an electrode array assembly that is wirelessly connected to an implantable pulse generator.
  • Implantable tissue stimulation systems are used for a wide variety of applications, such as the treatment and suppression of pain in humans by neuromodulation of spinal cord nerve signals. These systems may also be used for other applications of neuromodulation, such as cardiac pacing, treatment of depression, bladder control, and muscle movement.
  • These stimulation systems typically include an implantable battery-powered electronic stimulator unit (also known as an implantable pulse generator (IPG)), which provides sequenced electrical impulses to a stimulating electrode or electrode array.
  • IPG implantable pulse generator
  • An electrode array can be a thin, elongated member, or a paddle-shaped unit. Some electrode arrays are shaped to be inserted in the epidural space of the spinal column.
  • the implantable stimulator unit is often placed in a subcutaneous pocket either in the upper portion of the gluteus or in the lateral portions of the mid-abdomen.
  • the electrodes of the electrode array are connected to the stimulator unit by wire leads implanted in the body.
  • the stimulation unit causes one or more of the electrodes forming the array to emit an electrical signal.
  • This signal is applied to the neural network.
  • One use of such a signal is to override a signal that has been emitted from some other location within the body.
  • a signal may for example be signal generated by a damaged nerve indicating that a particular tissue or body location is in pain.
  • the pain signal can be modulated before it enters the brain. The modulation of this signal with the stimulating system thus eliminates or reduces the need to use drugs, with their attendant disadvantages in order to minimize the effects of the pain signal on the patient.
  • a disadvantage of known tissue stimulators is associated with the wire used to connect the stimulator unit and the electrode array. These wires are subjected to stress as a result of the inevitable movement of the surrounding tissue. This stress in turn, leads to wire breakage and/or separation from either the stimulator unit or electrode array.
  • the wires can fail at any point, particularly connection points and the point at which the wires exit the spinal column. This can make it necessary to remove the neuromodulation system and surgically implant a replacement system. In addition, failure of the connection points may result in contamination from biological material seeping into the stimulator unit.
  • the wires do not fail, they can pull on the electrode array as the body moves. This movement can cause electrode array migration which leads to inaccurate tissue stimulation. Such inaccurate tissue stimulation can lead to an ineffective treatment.
  • the wires can also be damaged by regular body movement such as repetitive movements of the spinal column.
  • the need to provide the wires adds to the surgical implantation of a tissue stimulation system as the wires must be tunneled through the patient from the electrode lead connection points of the electrode array to the implanted stimulator unit. This can involve extensive tunneling as the electrode array is typically located in the epidural space of the spinal column, and the implantable stimulator unit is often placed in a subcutaneous pocket either in the upper portion of the gluteus or in the lateral portions of the mid-abdomen.
  • the need to implant the stimulator unit and the wiring significantly increases the surgery time and the discomfort of the patient due to the need to implant the stimulator unit in an additional location in the body, and further increases the risk of infection. Then, additional time must be spent in the surgical procedure connecting the wires to the implantable pulse generator.
  • stimulation systems for treatment of humans have been unable to both effectively engage and stimulate targeted neuro-tissues without a complex system of lead wires implanted throughout the body connecting the pulse-emitting electrodes to the stimulation device providing the necessary power and command information to the electrodes .
  • This invention is directed to a new and useful implantable neurological tissue stimulator.
  • the stimulator of this invention includes an implantable pulse generator and an implantable electrode array assembly separate from the implantable pulse generator. Also part of this invention is a power supply module.
  • the power supply module is worn or carried by the individual in whom the power converter and electrode array assembly are implanted.
  • the power supply module transfers by radiant energy to the implantable pulse generator.
  • the pulse generator in turn converts the received power to a signal that will be less attenuated by internal body tissue.
  • the converter transmits this signal, wirelessly, to the electrode array assembly.
  • Embedded in the power signal are instructional data.
  • a front end receiver integral with the electrode array extracts the energy from the power signal.
  • the receiver extracts the instructions and forwards them to a drive circuit, also part of the electrode array assembly. Based on the received instructions, the drive circuit selectively applies energy to the electrodes.
  • the system of this invention therefore does not include a physical, wired connection between the power converter and the electrode array assembly. Therefore, the disadvantages associated by the presence of such a wire are eliminated.
  • FIG. 1 is a symbolic view of a human body
  • FIG. 2 is a cross sectional view of a human body embodying the present invention as taken along line II-II in FIG. 1;
  • FIG 3 is a block diagram of the components internal to a power supply module of this invention.
  • FIG 4 is a plan view of one face, the outer directed face, of a pulse generator of this invention.
  • FIG. 5 is a cross sectional view of the pulse generator depicting the primary components internal to the module
  • FIG 6 is a block diagram of the components internal to the pulse generator
  • FIG 7 is a side view of an electrode array assembly of this invention.
  • FIG 8 is a block diagram of the components internal to the electrode array assembly
  • FIG 9 is a schematic diagram of the power switch assembly connected to a single one of the electrodes of the electrode array assembly
  • FIG. 1 and FIG. 2 show an example of an implantable wireless neuromodulation
  • implantable pulse generator 34 Both the electrode array assembly 32 and pulse generator 34 are implanted in the patient. Also part of system 30 of this invention and worn or otherwise externally carried by the patient is a power supply module 36. The implantable components communicate and are powered via at least one wireless communication link. Power supply module 36 may include software to control the operation of the neurostimulation system and a power delivery system. As explained further below with reference to FIG. 3, implantable pulse generator 34 includes a power harvester and an energy converter. Also internal to the implantable pulse generator 34 is control circuitry and a radio frequency power delivery system for delivering power and control signals to the leadless electrode array assembly 32. As described in more detail below, implantable leadless electrode array assembly 32 includes an array of electrodes 124 ( Figure 7) .
  • FIG. 2 shows an axial cross section of the human body to demonstrate the system configuration in the body and the relative location of the system components to one another.
  • the power supply module 36 is located outside of the body.
  • Implantable pulse generator 34 is located immediately below the skin and subcutaneous fat layers 38 and above the muscle tissue 40 of the body.
  • Electrode array assembly 32 is located in the epidural space 40 of the spinal column 42. More particularly, the electrode array assembly is disposed against a section of the spinal cord 44 to which the stimulating signal is applied.
  • the implantable pulse generator 34 is advantageously implanted in the back of the patient to reduce the over all distance between the relay station and the leadless electrode array.
  • the present invention provides a controlled amount of stimuli to specific tissues in the body consistently and according to a stimulation program stored in the memory of the system.
  • the positive or negative polarity stimulation energy is transferred from the electrical medium to a tissue medium via the electrodes of the electrode array assembly 32.
  • Various configurations of electrodes and stimulus parameters on the electrodes will allow for electric field focusing or steering enhancing a controller's ability to target specific tissues.
  • the current flow between the electrodes of assembly 32 will modulate the flow of neural signals to or from the brain.
  • power supply module 36 includes a signal generator 52.
  • Signal generator 52 is configured to generate a signal in the high frequency to microwave frequency ranges. In some version of the invention, this signal as at a frequency somewhere between 30 MHz and 3 GHz.
  • the signal generator 52 is powered by a battery 53, also contained within the power supply module 36. While the connections are not shown for simplicity, the battery 53 powers the other active components internal to the power supply module. Battery 53 is rechargeable and/or disposable.
  • processor 54 Also internal to power supply module 36 is a processor 54.
  • Processor 54 may be any suitable microcontroller.
  • a memory 56 shown externally from the processor 54 contains the instruction set executed by the processor for operation of system 30.
  • I/O unit 58 Also shown connected to processor 54 is an I/O unit 58.
  • the I/O unit 58 may comprise a small display and a keypad, or a touch screen display.
  • the I/O unit 58 is the component of system 30 through which commands for controlling the electrodes are entered. Based on the data entered through the I/O unit 58 and the instructions stored in memory 56, the processor 54 generates the instructions for actuating specific electrodes 124 integral with electrode array assembly 32.
  • the I/O unit 58 also serves as the system component over which data regarding the operation of system 30 and data based on neurological signals measured by the system are presented to the patient or clinician.
  • FIG. 3 a resistor 57 is shown connected across battery 53.
  • the voltage across resistor 57 is applied to processor 54.
  • the fall of this voltage below a certain threshold is interpreted by processor 54 as an indication battery 53 is losing its charge.
  • processor 54 directs I/O unit 58 to generate an appropriate warning message to the user.
  • the processor 54 outputs instructions that cause the electrodes to be actuated in a power saving mode. This ensures that system 30 remains able to function, though perhaps at a reduced level of effectiveness, for an extended period when it would otherwise shut down due to battery discharge.
  • the command signals output by the processor 54 are forwarded to a modulator/demodulator 60.
  • the signal produced by the signal generator 52 is also forwarded to the modulator/demodulator 60.
  • This latter signal functions as carrier signal.
  • Modulator/demodulator 60 thus modulates the carrier signal based on the command signals received from processor 54.
  • the carrier signal is subjected to pulse width modulation, frequency shift keying, amplitude shift keying phase shift keying, frequency modulation or amplitude modulation.
  • Modulator/demodulator 60 outputs the modulated signal to an antenna 62. From the antenna 62, the signal is broadcast to the patient.
  • the signal broadcast by power supply module 36 is at least 100 ⁇ Watts. It should be appreciated that the maximum power will be dictated by the maximum specific absorption rates allowed by the appropriate regulatory agencies. In the United States, these agencies are the Food and Drug Administration and the Federal Communications Commission.
  • Antenna 62 also receives signals emitted by implantable pulse generator 34. Data signals integral with these signals are extracted by modulator/demodulator 60 and forwarded to processor 54. These data signals may include data describing the electrical energy delivered to the patient, the impedance to the delivery of this energy or sensed signals relating to the patient's nerve functions. These data may then be used by processor 54 as an input variable for regulating the actuation of the system electrodes .
  • power supply module 36 is worn by the patient.
  • power supply module 36 has a size of 130 cm 3 or less and, preferably, 100 cm 3 or less. This allows the module 36 to be worn on a belt, attached to an article of clothing or carried in purse, pack or pocket.
  • the specific means by which the power supply module 36 is carried by the patient is not relevant to this invention. What is significant is that the means by which the power supply module 36 is carried is such that it allows the module to be positioned so that it can exchange signals with implantable pulse generator 34 with loss of signal strength of 75% or less and more preferably, a loss of signal strength of 50% or less.
  • Implantable pulse generator 34 receives and harvests the HF/MW signal produced by the power supply module 36.
  • the pulse generator 34 includes a housing 72 designed so that it can be implanted immediately below the skin and below or in subcutaneous fat layers so to cause minimal discomfort.
  • housing 72 is generally rectangular in shape and further formed to have rounded corners.
  • housing 72 occupies a surface area of 15 cm 2 or less and has an overall thickness of 1 cm or less.
  • housing 72 has a rectangular frame 74 formed of biocompatible material.
  • biocompatible material include: metals, such as tantalum; ceramics, such as alumina ceramics; and plastics, such as polyethylene plastics.
  • Frame 74 supports two parallel, spaced apart face plates, outer plate 76 and inner plate 78. Embedded within or adhered to the inner surface of outer face plate 76 is a high frequency antenna 80. Embedded within or adhered to the inner surface of inner face plate 78 is a low frequency antenna 108.
  • Substrate 82 supports the remaining below- described signal processing and power storing components of the pulse generator 34.
  • Implantable pulse generator high frequency antenna 80 is designed to maximize the exchange of signals with the power supply antenna 62.
  • the signals received by converter antenna 80 are applied to two processing circuits, seen in Figure 6.
  • a first one of the processing circuits to which the signal out from antenna 80 is applied is a power extraction and storage circuit.
  • this circuit is represented by a capacitor 84 tied between antenna 80 and ground an inductor 86 and a diode 87.
  • One end of the inductor 86 is connected to the junction between antenna 80 and capacitor 84.
  • the opposed end of inductor 86 is connected to a forward biased diode.
  • the opposed end of diode 87 is tied to a rechargeable battery 88, also part of the power extraction and storage circuit.
  • capacitor 84, inductor 86, diode 87 and battery 88 represent that the pulse generator power extraction and storage circuit converts the AC signal developed across antenna 80 into a storable charge and stores the charge for use by other components internal to the implantable pulse generator 34. For purposes of simplicity, the connection of the power signal supplied by battery 88 to most of the other components internal to the pulse generator 34 are not shown.
  • High frequency antenna 80 of pulse generator 34 is also connected to a high frequency (HF) modulator/ demodulator 92. Modulator/demodulator 92 extracts the data signals from the signals received by antenna 80. The signals extracted by modulator/demodulator 92 are forwarded a relay processor 94.
  • HF high frequency
  • a low frequency signal generator 98 Also internal to implantable pulse generator 34 is a low frequency signal generator 98.
  • the low frequency signal generator 98 which, like other components of module 34, is powered by battery 88, generates a signal at frequency that will, with a minimum of attenuation, pass through the tissue internal to the patient. Generally, the signal output between 100 kHz and 20 MHz.
  • the signal produced by low frequency signal generator 98 is employed by a low frequency (LF) modulator/demodulator 104 as a carrier signal.
  • the signal produced by relay processor 94 is the modulating signal.
  • the function of relay processor is to convert the data stream received from modulator/demodulator 92 into a format wherein the signals containing the data can be used to modulate the low frequency signal. In some versions of the invention, no such conversion is required.
  • the data signal extracted from HF modulator/demodulator 92 is applied directly to LF modulator/demodulator .
  • Pulse generator 34 also includes a high frequency signal generator 110.
  • the high frequency signal generator 110 produces a carrier signal at the same frequency as the carrier signal produced by power supply module signal generator 52.
  • the signal produced by high frequency signal generator 110 is applied to modulator/demodulator 104.
  • the modulator/ demodulator 104 uses the signal from generator 110 as a carrier signal. Specifically, this signal is used as a carrier signal when relay processor 94 instructs the modulator/demodulator 104 to transmit data back to the power supply module 36.
  • both low frequency signal generator 98 and high frequency signal generator 110 are selectively actuated. Specifically, in order to conserve power, both signal generators are normally off.
  • Relay processor 94 turns on the low frequency signal generator 98 whenever there is a need to transmit data or power the electrode array assembly 32.
  • the relay processor 94 turns on the high frequency signal generator whenever there are data to transmit to the power supply module 36.
  • Electrode array assembly 30 includes a flexible substrate 122 formed from biocompatible material. Disposed on one side of the substrate 122 is an array of electrodes 124. The assembly of Figure 7 is shown as having only five (5) electrodes 124. This is understood to be only for purposes of illustration. In practice, in many versions of the invention fewer or more electrodes 124 may be integral with the electrode array assembly. Each electrode 124 will occupy a surface area of between 0.25 mm 2 and 6 mm 2 . Disposed on the opposed side of substrate 122 is a low frequency antenna 126. Disposed on the same side of substrate 122 as antenna 126 are below described components that apply current to the electrodes 124. In Figure 7, these components are diagrammatically represented as rectangles 127 and 145. Not shown are the vias that extend through substrate 124. The vias are the conductive paths over which current is applied to the electrodes 124.
  • Antenna 126 is designed to maximize signal exchanges with the low frequency signal broadcast by pulse generator antenna 108.
  • the signal from antenna 126 is applied to a power extractor and supply circuit.
  • the electrode array assembly power extractor and supply circuit is represented by a capacitor 128, an inductor 130, a diode 131 and a rechargeable cell 132.
  • the capacitor 128 is shown connected between antenna 126 and ground.
  • One end of inductor 130 is connected to the junction between the antenna 126 and the capacitor 128.
  • the opposed end of inductor 130 is connected to the forward biased diode 131.
  • the second of diode 131 is tied to the positive terminal of rechargeable cell 132.
  • the charge stored in cell 132 is applied to two power supplies 136 and 138.
  • Power supply 136 generates a regulated positive DC signal.
  • the signal produced by power supply 136 is applied to plural variable gain amplifiers 140, plural amplifiers 140a and 140b seen in Figure 9. For simplicity, only a single amplifier is illustrated.
  • Power supply 138 generates a regulated negative DC signal.
  • the signal produced by power supply 138 is applied to plural variable gain amplifiers 142; plural amplifiers 142a and 142b seen in Figure 9.
  • the power harvested by the electrode array assembly 32 is also applied to a low frequency signal generator 144.
  • the low frequency generator 144 produces a carrier signal at the same frequency at which the carrier produced by pulse generator low frequency generator signal generator 98 is produced.
  • cell 132 also powers the other components integral with the electrode array assembly 32.
  • the signal that develops across antenna 126 is also applied to a modulator/demodulator 146.
  • Modulator/ demodulator 146 extracts the data signals from the signals received from antenna 126. These data signals are applied to a stimulation sequence generator 148.
  • stimulation sequence generator 148 is a programmable gate array.
  • the signals extracted by modulator/demodulator 146 are the instructions that indicate what currents should be applied to the individual electrodes 124 and the combination of electrodes and/or sequence in which these currents should be applied.
  • each set of instructions includes a code indicating in which electrode combination and/or sequence current should be applied to the electrodes.
  • Each set of instructions also includes data indicating the strength of the current to be applied.
  • stimulation sequence generator 148 retrieves from an associated memory 150 a sequence listing.
  • the sequence listing is the actual instructions for regulating how the below described components apply currents to the individual electrodes. Additional data in the instructions received by the stimulation sequence generator 148 can include the strengths of the currents to be applied to the individual electrodes. Based on these data, stimulation sequence generator 148 sets the gains of amplifiers 140 and 142.
  • Stimulation sequence generator 148 clocks out the instructions causing the appropriate actuation of the electrodes 124.
  • the clocking out of these signals is based on a constant frequency clock signal.
  • this clock signal is supplied by a clock 152 shown as a separate component and connected to the stimulation sequence generator 148.
  • a power supply switch circuit 156 is the actual circuit that applies the currents to the individual electrodes 124.
  • Switch circuit 156 includes, for each electrode 124 a number of switches that can selectively tie the electrode to each of the amplifiers 140 and 142.
  • the switches that control the application of current to a single one of the electrodes are shown as a series of FETs.
  • the output signal from a first one of the positive voltage amplifiers, amplifier 140a is shown as being applied to the electrode 124 through a FET 162 and a FET 166.
  • the output signal from a second one of the positive voltage amplifiers, amplifier 140b is shown as being applied to the electrode 124 through a FET 164 and FET 166.
  • power supply switching circuit 156 can be considered a multiplexer .
  • the stimulation sequence generator 148 asserts the gate signals to FETs 162-172 to ensure the appropriate signal is applied to each electrode. It should be understood that, during some stimulation processes a signal may not be applied to a particular electrode 124. In this instance one or more of the FETs 162-172 tied to a particular electrode may be turned off. The turning off of the appropriate FETs essentially disconnects the particular electrode from the rest of the electrode array assembly 32.
  • the voltage present at the electrode 124 is also measured by the electrode array assembly 32. This is shown by the tap off between electrode 124 and the junctions of electrodes 166 and 172. The signal present at this point is applied to an analog to digital converter. 176.
  • a single ADC connected to a single electrode 124 is shown. While not shown, it should be appreciated that a high impedance buffer circuit may be connected to this tap off. This circuit minimizes the loss of current in the signal applied to the ADC 176.
  • the digitized representation of electrode voltage produced by ADC 176 is applied to the stimulation sequence generator 148.
  • the stimulation sequence generator based on preprogrammed instructions that are always, executed, the stimulation sequence generator periodically forwards the digitized representations of electrode voltage to the modulator/demodulator 146. Modulator/demodulator then periodically broadcasts these signals back to pulse generator 34 over antenna 126.
  • the signal produced by low frequency signal generator 144 is used as the carrier signal.
  • the signals carrying the electrode voltage level data are only broadcast by the electrode array assembly 32 in response to a specific write request. In both versions of the invention it should be appreciated that, the implantable pulse generator 34, upon receipt of these signals, forwards these signals to the power supply module 36.
  • the electrode array assembly is positioned in the spinal column 42 so that the individual electrodes 124, 124a-e in Figure 7, are disposed against the spinal cord.
  • processor 54 When the system is actuated, processor 54 generates instructions indicating to which specific electrodes 124 the voltages should be applied. These data are broadcast by antenna power supply 36 over antenna 62.
  • Implantable pulse generator 34 receives these signals over high frequency antenna 80. The power contained in these signals is stored in rechargeable battery 88.
  • Modulator/demodulator 92 extracts the instruction signal transmitted by the power supply module.
  • the relay processor 94 if necessary, forwards the extracted signals to the low frequency modulator/demodulator 104.
  • the instruction signals or just the carrier signal are broadcast by low frequency antenna 108 to the electrode array assembly 32.
  • the power contained in the signals received by the electrode array assembly 32 is stored in cell 132.
  • the instructions extracted from the signals by the modulator/demodulator 146 are forwarded to the stimulation sequence generator 148.
  • stimulation sequence generator 148 Based on these data and the sequence pattern data retrieved from memory 150, stimulation sequence generator 148 clocks out instructions to the power switches 156 indicating which electrodes 124 are to be tied to which voltage source (which amplifier 140a, 140b, 142a or 142c) .
  • the stimulation sequence generator 148 Based on both the received instructions and sequence data, the stimulation sequence generator 148 also establishes the gain of amplifiers 140a, 140b, 142a and 142b.
  • This current flows through the nerves forming the spinal cord 44.
  • this current flow is represented by dashed lines from electrode 124b to adjacent electrodes 124d and 124e.
  • this energy stimulates the dorsal columns of the spinal cord.
  • This stimulation causes the nerves in this section of the spinal cord to emit action potentials. It is believed that the action potentials produced by these nerves in this section of the spinal cord along with chemical and hemodynamic factors influence the inputs to the brain' s percept of pain at a given dermatomal level due to the input of pain signals from pain sensing nerves.
  • electrodes 124 can be arranged on a substrate in a pattern other than a pure linear pattern.
  • the electrodes 124 could be arranged in a matrix wherein there are plural rows some of which contain two or more electrodes.
  • the electrodes can be selected for actuation so that there is not necessarily a 1:1 ratio to which positive and negative voltages are, respectively, applied. This makes it possible to focus the current on specific sections of tissue in order to accomplish the desired therapeutic effect.
  • electrodes 124 can also by patient feedback determine optimal electrode selection, polarity and charge sequencing in order to accomplish the desired therapeutic effect.
  • the surface spinal cord dura is curved. Therefore, it may be desirable to provide the electrode array assembly with members to ensure that the electrodes remain in contact with the spinal cord 44.
  • One such assembly is seen in Figure 10.
  • a curved biasing member 182 is shown to extend upwardly from the outer surface of the substrate 122a. The outer surface of the biasing member abuts the epidural-defining surface of the adjacent vertebra. The biasing member thus pushes the substrate 122a and by extension, the electrodes 124 towards the dura of the spinal cord 44. This intimate contact provides stability for the electrodes and reduces the impedance to electrical current.
  • the substrate of the electrode array assembly 32 is provided with a C-shaped cuff formed of flexible material (cuff not illustrated) .
  • This cuff urges the substrate around, and the electrodes against the spinal cord dura.
  • the backing or cuff can be formed of flexible material that, when compacted and released from a delivery cannula, expands to approximately its original shape. Either the cuff or the backing allows the electrode array assembly to be inserted percutanously .
  • the electrodes may be disposed on plural substrates. Typically, but not always, in this version of the invention, each electrode-carrying substrate includes its own array of plural electrodes.
  • each substrate contains its own components for both receiving power from the pulse generator and regulating the application of this power to the individual electrodes.
  • flexible strips may connect the individual substrates together.
  • the array of plural electrodes is supported by a single substrate
  • These additional substrates support the antenna 126 and and/or the associated energy storage, control and drive circuits.
  • flex circuits extend between the individual substrates.
  • antenna 108 may extend out of the implantable pulse generator 34.
  • the implantable pulse generator housing may be formed from material that has some flexibility. Thus, the materials from which the various components of the system 30 of this invention may be formed can be different from what has been described.
  • the electrode array could be constructed as a multi-layer MEMS structure.
  • antenna 126 is formed on one face of the structure.
  • the electrodes 124 are formed on the opposed face.
  • One or more of the power extraction, power storage and control and drive components are formed on intermediate layers of the MEMS structure.
  • some of these components of the electrode array assembly 32 are formed on a first MEMS structure, other ones of the components are formed on a second, or even a third MEMS structure/structures .
  • the electrode array assembly 32 may even include a circuit that includes the sensed electrode voltage readings and the known excitation currents into impedance measurements. Data describing these impedance measurements are what are transmitted by the electrode array assembly 32 and then relayed by the implantable pulse generator 34 to the power supply module 36. Also, in some versions of the invention, it may not be necessary to provide power supply circuits. In these versions of the invention the storage device, (the capacitor or cell) that holds the charge extracted from the signal from the implantable pulse generator may be selectively connected to the electrodes by power switches 156. Amplifiers 140 and 142 may similarly not be present in all versions of the invention.
  • Capacitors could replace the implantable batteries.
  • the described processors may not truly be processors that operate based on loaded instructions.
  • a processor may for example by a programmable gate array or an application specific integrated circuit (or circuits) that generate the requisite output in response to the received input signals or instructions.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un système de neuromodulation implantable (30) comprenant un ensemble de réseaux d'électrodes (32) et un générateur d'impulsions implantable (34). Les signaux sont translatés par réseau sans fil du générateur d'impulsions implantable à l'ensemble de rangées d'électrodes. Un extracteur de courant et un circuit d'alimentation intégré à l'ensemble de rangées d'électrodes extraient le courant des signaux. Les instructions contenues dans les signaux sont exécutées par un circuit de commutation (156) faisant également partie de l'ensemble de rangées d'électrodes en vue de l'écoulement sélectif du courant entre certaines des électrodes sélectionnées (124) faisant partie de l'ensemble.
PCT/US2007/088580 2006-12-22 2007-12-21 Système de neuromodulation implantable comprenant un générateur d'impulsions à connexion sans fil et ensemble de rangées d'électrodes Ceased WO2008080073A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87167506P 2006-12-22 2006-12-22
US60/871,675 2006-12-22

Publications (2)

Publication Number Publication Date
WO2008080073A2 true WO2008080073A2 (fr) 2008-07-03
WO2008080073A3 WO2008080073A3 (fr) 2008-08-28

Family

ID=39535209

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/088580 Ceased WO2008080073A2 (fr) 2006-12-22 2007-12-21 Système de neuromodulation implantable comprenant un générateur d'impulsions à connexion sans fil et ensemble de rangées d'électrodes

Country Status (1)

Country Link
WO (1) WO2008080073A2 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011017426A3 (fr) * 2009-08-05 2011-10-27 Stryker Corporation Ensemble réseau d'électrodes implantable comprenant un support pour supporter les électrodes et des modules de commande pour réguler le fonctionnement des électrodes encastrées dans le support, et son procédé de fabrication
US8554340B2 (en) 2009-08-05 2013-10-08 Stryker Corporation Implantable electrode array assembly including a carrier, superstrates mounted to the carrier and electrodes disposed on the superstrates
US8560083B2 (en) 2008-03-06 2013-10-15 Stryker Corporation Foldable, implantable electrode assembly
US8951426B2 (en) 2011-05-17 2015-02-10 Stryker Corporation Method of fabricating an implantable medical device that includes one or more thin film polymer support layers
US9002451B2 (en) 2008-09-11 2015-04-07 Stryker Corporation Implantable electrode array assembly with extraction sleeve/tether
EP3090778A1 (fr) 2008-05-30 2016-11-09 Stryker Corporation Procédé d'assemblage de rangées d'électrodes implantables avec une forme courbée
US9564777B2 (en) 2014-05-18 2017-02-07 NeuSpera Medical Inc. Wireless energy transfer system for an implantable medical device using a midfield coupler
US9610457B2 (en) 2013-09-16 2017-04-04 The Board Of Trustees Of The Leland Stanford Junior University Multi-element coupler for generation of electromagnetic energy
US9937338B2 (en) 2008-03-06 2018-04-10 Stryker Corporation Electrode array and deployment assembly including an electrode array that is folded into a cannula that is narrower in width than the array
WO2019060332A1 (fr) * 2017-09-19 2019-03-28 The United States Government As Represented By The United States Department Of Veteran Affairs Stimulateur de tissu implantable flexible et procédé pour le fabriquer et l'utiliser
US11338148B2 (en) 2015-05-15 2022-05-24 NeuSpera Medical Inc. External power devices and systems
US11478631B2 (en) 2012-02-02 2022-10-25 The United States Government As Represented By The Department Of Veterans Affairs Methods of using an integrated surface stimulation device for wound therapy and infection control

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1702648B1 (fr) * 1997-03-27 2015-03-18 The Alfred E Mann Foundation for Scientific Research Système comprenant des appareils implantables pour surveiller et modifier des paramètres physiologiques d'un patient
US5935155A (en) * 1998-03-13 1999-08-10 John Hopkins University, School Of Medicine Visual prosthesis and method of using same
ATE336279T1 (de) * 2000-11-16 2006-09-15 Polyvalor Sec Elektronisches körperimplantat und system zum künstlichen sehen
US20060184209A1 (en) * 2004-09-02 2006-08-17 John Constance M Device for brain stimulation using RF energy harvesting

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8560083B2 (en) 2008-03-06 2013-10-15 Stryker Corporation Foldable, implantable electrode assembly
US9937338B2 (en) 2008-03-06 2018-04-10 Stryker Corporation Electrode array and deployment assembly including an electrode array that is folded into a cannula that is narrower in width than the array
US10780262B2 (en) 2008-05-30 2020-09-22 Stryker Corporation Method of assembling an electrode array that includes a plastically deformable carrier
EP3090778A1 (fr) 2008-05-30 2016-11-09 Stryker Corporation Procédé d'assemblage de rangées d'électrodes implantables avec une forme courbée
US9002451B2 (en) 2008-09-11 2015-04-07 Stryker Corporation Implantable electrode array assembly with extraction sleeve/tether
WO2011017426A3 (fr) * 2009-08-05 2011-10-27 Stryker Corporation Ensemble réseau d'électrodes implantable comprenant un support pour supporter les électrodes et des modules de commande pour réguler le fonctionnement des électrodes encastrées dans le support, et son procédé de fabrication
US8554340B2 (en) 2009-08-05 2013-10-08 Stryker Corporation Implantable electrode array assembly including a carrier, superstrates mounted to the carrier and electrodes disposed on the superstrates
US8781600B2 (en) 2009-08-05 2014-07-15 Stryker Corporation Implantable electrode array assembly including a carrier in which control modules for regulating the operation of the electrodes are disposed and electrodes that are disposed on top of the carrier
US10525258B2 (en) 2009-08-05 2020-01-07 Stryker Corporation Implantable electrode array assembly including a carrier with packaged control modules
US9950154B2 (en) 2009-08-05 2018-04-24 Stryker Corporation Method of manufacturing an implantable electrode array by forming packages around the array control modules after the control modules are bonded to substrates
US9770582B2 (en) 2009-08-05 2017-09-26 Stryker Corporation Implantable electrode array assembly including a carrier with embedded control modules contained in packages, the packages extending outwardly so as to extend over the carrier
US9700262B2 (en) 2011-05-17 2017-07-11 Stryker Corporation Method of fabricating implantable medical devices from a polymer coupon that is bonded to rigid substrate
US10756043B2 (en) 2011-05-17 2020-08-25 Stryker Corporation Method of fabricating implantable medical devices from a polymer coupon that is bonded to a rigid substrate
US8951426B2 (en) 2011-05-17 2015-02-10 Stryker Corporation Method of fabricating an implantable medical device that includes one or more thin film polymer support layers
US11478631B2 (en) 2012-02-02 2022-10-25 The United States Government As Represented By The Department Of Veterans Affairs Methods of using an integrated surface stimulation device for wound therapy and infection control
US9610457B2 (en) 2013-09-16 2017-04-04 The Board Of Trustees Of The Leland Stanford Junior University Multi-element coupler for generation of electromagnetic energy
US10039924B2 (en) 2013-09-16 2018-08-07 The Board Of Trustees Of The Leland Stanford Junior University Wireless midfield systems and methods
US9687664B2 (en) 2013-09-16 2017-06-27 The Board Of Trustees Of The Leland Stanford Junior University Multi-element coupler for generation of electromagnetic energy
US9662507B2 (en) 2013-09-16 2017-05-30 The Board Of Trustees Of The Leland Stanford Junior University Multi-element coupler for generation of electromagnetic energy
US9744369B2 (en) 2013-09-16 2017-08-29 The Board Of Trustees Of The Leland Stanford Junior University Multi-element coupler for generation of electromagnetic energy
US9583980B2 (en) 2014-05-18 2017-02-28 NeuSpera Medical Inc. Midfield coupler
US9564777B2 (en) 2014-05-18 2017-02-07 NeuSpera Medical Inc. Wireless energy transfer system for an implantable medical device using a midfield coupler
US12176725B2 (en) 2014-05-18 2024-12-24 NeuSpera Medical Inc. External power devices and systems
US11338148B2 (en) 2015-05-15 2022-05-24 NeuSpera Medical Inc. External power devices and systems
WO2019060332A1 (fr) * 2017-09-19 2019-03-28 The United States Government As Represented By The United States Department Of Veteran Affairs Stimulateur de tissu implantable flexible et procédé pour le fabriquer et l'utiliser
US11458309B2 (en) 2017-09-19 2022-10-04 United States Government As Represented By The Department Of Veterans Affairs Flexible implantable tissue stimulator and methods of making and using same

Also Published As

Publication number Publication date
WO2008080073A3 (fr) 2008-08-28

Similar Documents

Publication Publication Date Title
WO2008080073A2 (fr) Système de neuromodulation implantable comprenant un générateur d'impulsions à connexion sans fil et ensemble de rangées d'électrodes
US12527955B2 (en) Method of implanting a nerve stimulation device in treating an overactive bladder condition
CN104096313B (zh) 一种植入式神经电刺激装置与系统
US8175717B2 (en) Ultracapacitor powered implantable pulse generator with dedicated power supply
US10456574B2 (en) Systems and methods for reducing power consumption in an implantable medical device
US7245972B2 (en) Electrical treatment to treat shoulder subluxation
JP5224478B2 (ja) 患者の活動を計測する神経刺激システム
CA2905101C (fr) Systeme et procedes pour un recepteur de puissance sans fil implantable
Xu et al. A fully implantable stimulator with wireless power and data transmission for experimental investigation of epidural spinal cord stimulation
US20090326611A1 (en) Method of Powering Implanted Devices by Direct Transfer of Electrical Energy
US20050283202A1 (en) Neuromodulation system
US20160339253A1 (en) Coupled monopolar and multipolar pulsing for conditioning and stimulation
US20160106985A1 (en) Neuromodulation using modulated pulse train
US20110004269A1 (en) Implantable pulse generator for providing functional and/or therapeutic stimulation of muscles and/or nerves and/or central nervous system tissue
EP2849841B1 (fr) Système thérapeutique sans fil implantable
WO2007106692A2 (fr) Appareil de stimulation du nerf vague et procédés associés
US20250249240A1 (en) Systems and methods for inducing muscle contraction

Legal Events

Date Code Title Description
NENP Non-entry into the national phase

Ref country code: DE

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

Ref document number: 07869760

Country of ref document: EP

Kind code of ref document: A2

122 Ep: pct application non-entry in european phase

Ref document number: 07869760

Country of ref document: EP

Kind code of ref document: A2