CN107614057A - Flexible circuit for implantable devices - Google Patents

Flexible circuit for implantable devices Download PDF

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Publication number
CN107614057A
CN107614057A CN201680031309.4A CN201680031309A CN107614057A CN 107614057 A CN107614057 A CN 107614057A CN 201680031309 A CN201680031309 A CN 201680031309A CN 107614057 A CN107614057 A CN 107614057A
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CN
China
Prior art keywords
flexible circuit
electrode
substrate
circuit according
current
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CN201680031309.4A
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Chinese (zh)
Inventor
L·T·佩里曼
C·D·安德烈森
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Micron Devices LLC
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Micron Devices LLC
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Publication of CN107614057A publication Critical patent/CN107614057A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37205Microstimulators, e.g. implantable through a cannula

Abstract

A kind of flexible circuit, including:Substrate;One or more radio frequencies (RF) port on substrate, these ports are configured as being coupled to RF antennas, and these RF antennas are configured as receiving the RF pulses from peripheral control unit equipment;One or more groups of components on substrate, one or more groups of components are configured as extracting RF energy from the RF pulses received and deliver the electric pulse for being applied to stimulate nerve fiber;Integrated circuit (IC) component on substrate, the IC components are configured as being based only upon the electric pulse that extracted RF energy generation is applied to stimulate nerve fiber;And wherein the substrate, the one or more groups of components and integrated circuit member are resized and are positioned on substrate so that flexible circuit is bent during implantation within a patient, without becoming inoperable.

Description

Flexible circuit for implantable devices
Technical field
Present invention relates generally to implantable stimulator.
Background technology
The excitable tissue in body is adjusted by electro photoluminescence to have become for a kind of important of chronic patient of disabling Therapy, including chronic ache, it is motion actuated and control the problem of, involuntary movement, vascular insufficiency, arrhythmia cordis, even More.The various internal electrical stimulation technologies for the treatment of can treat these illnesss.For example, equipment can be used to pass stimulus signal Excitable tissue is given, records vital sign, performs pace-making or defibrillation procedure, the action potential from institute's target tissue is recorded and lives It is dynamic, the insoluble drug release from time-release capsules or Teat pipette unit is controlled, or enter line interface with auditory system and be connected to aid in Hearing.Typically, the subcutaneous battery-operated implantable impulse generator (IPG) of such equipment utilization come provide electric power or other Charge-storage mechanism.
The content of the invention
In one aspect, some embodiments provide a kind of flexible circuit, and the flexible circuit includes:Substrate;On substrate One or more radio frequencies (RF) port, the port is configured as being coupled to RF antennas, and the RF antennas are configured as reception and come from The RF pulses of peripheral control unit equipment;One or more groups of components on substrate, one or more groups of components are configured as from institute RF energy is extracted in the RF pulses of reception and delivers the electric pulse for being applied to stimulate nerve fiber;Integrated circuit on substrate (IC) component, the IC components are configured as being based only upon extracted RF energy to generate the electric arteries and veins for being applied to stimulate nerve fiber Punching;And wherein the substrate, the one or more groups of components and integrated circuit member are resized and are positioned on substrate, make Obtain flexible circuit to bend during implantation within a patient, without becoming inoperable.
Embodiment can include one or more of following features feature.
Substrate can be sized to fit through the pin no more than No. 13 (gauge).Substrate, which can have, to be not less than 50 aspect ratio.
Every group of component can include the component that width is not more than 3mm, and these components can be spaced apart and be not more than 0.75mm.The height of these components can be between 0.6mm-0.8mm.Every group of component and IC components interval 1.25mm or bigger.
At least one component can include the capacitor not less than 1 μ F.One or more groups of components can include multiple electricity Container.These component groups (the banks of component bank) can be configured as from the RF pulses received RF energy is extracted in a part and stimulus waveform parameter and polarity set are extracted from the Part II of the RF pulses received, And wherein Part I can be prior to Part II.
IC components are arranged to:Configure the electrode setting according to the polarity set extracted.
Flexible circuit can also include the one or more electrodes that could attach to the electrode that will be placed in around nerve fiber Interface.
One or more groups of components can be configured as by suitable for stimulate nerve fiber electric pulse be delivered to one or Multiple electrodes interface so that nerve fiber is led to according to the stimulus waveform parameter extracted from the Part I of the RF pulses received Electric pulse is crossed to stimulate.
One or more electrode interfaces can be configured as basis and be extracted from the Part II of the RF pulses received Polarity set adjust the polarity set on electrode.When making the first end of flexible circuit towards the second end of flexible circuit When bending make it that first end and the second end are formed sharply up to 45 ° of angle, the component on the flexible circuit is not from base Come off on plate.
Flexible circuit can also include:One or more solder pot pads (solder pond pad), the weldering of these solder pots Disk is configured as that tension force localizing in welding process so that surface mountable member on the flexible circuit will not be due to welding Heat and shift.
Brief description of the drawings
Fig. 1 shows the high-level diagram of the example of wireless stimulating system.
Fig. 2 shows the detailed view of the example of wireless stimulating system.
Fig. 3 is the circuit diagram for an example for showing wireless implantable stimulator device.
Fig. 4 is the circuit diagram of another example of wireless implantable stimulator device.
Fig. 5 is the diagram of example application specific integrated circuit (ASIC) chip for implantable purposes.
Fig. 6 show figure 5 illustrates asic chip work during exemplary sequence.
Fig. 7 A show the example A SIC chip models of the asic chip for being shown in Fig. 5.
Fig. 7 B show the example waveform of the chip model emulation based on Fig. 7 A.
Fig. 8 A show the example current guidance feature of the asic chip shown in Fig. 5.
Fig. 8 B show the example waveform at each point in the asic chip with conduct current feature.
Fig. 9 A- Fig. 9 B show the example of the flexible circuit of implantable nerve stimulation apparatus.
In various figures, similar reference indicates similar element.
Embodiment
In various embodiments, disclose and apply one or more for excitable tissue's (such as neural) to being targetted The system and method for individual electric pulse, for treating chronic ache, inflammation, arthritis, sleep apnea, epilepsy, incontinence (incontinence), the pain related to cancer, incontinence, it is motion actuated and control the problem of, involuntary movement, vascular function Incomplete, arrhythmia cordis, obesity, diabetes, craniofacial pain (such as antimigraine or cluster headache) and Other diseases.In some realities Apply in mode, equipment can be used in the case of no cable or inductive by using remote radio frequency (RF) energy pair Passive implantation type wireless stimulator device power supply is come to the nerve fiber transmission electric energy targetted.The nerve targetted can wrap Include, but be not limited to, spinal cord and peripheral region, including dorsal horn, DRGs send nerve root, neuromere, dorsal column fiber and Leave peripheral nerve bundle (such as vagus nerve, pillow nerve, trigeminal neuralgia, hypoglossal nerve, sacral nerve, the tail god of dorsal column and brain Through etc.).
Wireless stimulating system can include with one or more electrodes and one or more conductive antennas (for example, dipole Antenna or paster antenna) implantable stimulator device, and for frequency waveform and the internal circuit of electric energy rectification.The system Can also include peripheral control unit and for both do not have cable and also without in the case of inductive by from external source Radio frequency or microwave energy are sent to implantable stimulator device to provide the antenna of electric power.
In various embodiments, therefore wireless implantable stimulator device, which is wirelessly powered, (and is not required to Want the power supply of wired connection or such as battery), and contain the circuit for being used to receive needed for the pulse command in next exogenic source. For example, various embodiments are coupled to receive RF electric power using internal dipole (or other) antenna configuration by electric radiation.This allows Such equipment is produced in the case of not with the physical connection of implantable impulse generator (IPG) or without using induction coil Life can stimulate the electric current of nerve tract.
According to some embodiments, electrode and be used for that wireless implantable stimulator device is contained in the equipment Application specific integrated circuit (ASIC) chip interacted with peripheral control unit.Asic chip can be sent out from being received by peripheral control unit RF electric power is obtained to be powered to wireless implantable stimulator device (including asic chip) in the input signal sent.Asic chip is also Waveform parameter can be extracted from the input signal received and is used to pass through electrode stimulating to produce using such information The electric pulse of excitable tissue.Especially, asic chip includes conduct current feature (current steering feature), For current mirror equably to be mapped into each electrode while compact chip size is kept.Moreover, asic chip can To extract polarity set information from the input signal received and the polarity of electrode interface set using such information.
Embodiment includes flexible circuit, and various components, such as rectification circuit, waveform adjustment are included on the flexible circuit Circuit, voltage regulator, shunt resistance device, and asic chip.Various components to flexible circuit and thereon carry out shape and Size adjusting so that the flexible circuit being integrated into nerve stimulator equipment can be passed through the interior of the pin of No. 13 or smaller Chamber.Especially, each of various components are retained as width no more than 3mm and are spaced apart more than 0.175mm, to maintain the circuit Overall flexibility ratio.
Fig. 1 shows the high-level diagram of the example of wireless stimulating system.This is wireless, and stimulating system can include four mainly Component, i.e. programmable device module 102, RF pulse generator modules 106, transmitting (TX) antenna 110 are (for example, paster antenna, gap Antenna or dipole antenna), and implantation type wireless stimulator device 114.Programmable device module 102 can be computer equipment, all As run (such as bluetooth of support wireless connection 104) software application smart mobile phone.Except other work( Can be outer, the application can also allow users to check system mode and diagnosis situation, change various parameters, increase/reduction electrode The desired stimulation amplitude of pulse, and adjust the feedback sensitivity of RF pulse generator modules 106.
RF pulse generator modules 106 can include supporting the communication electronics of wireless connection 104, stimulation circuit and For the battery of electrical generator components power supply.In some embodiments, RF pulse generator modules 106 include its embedded encapsulation TX antennas in form factor (packaging form factor), but in other embodiments, TX antennas pass through wired Connection 108 or wireless connection (not shown) and be connected to RF pulse generator modules 106.TX antennas 110 can be coupled directly to Tissue, to produce the electric field powered to implantation type wireless stimulator device 114.TX antennas 110 by RF interfaces and implanted without Line stimulator device 114 is communicated.It is modulated and is encoded by RF pulse generator modules 110 for example, TX antennas 110 radiates RF transmission signal.The implantation type wireless stimulator device of module 114 includes one or more antennas, such as dipole antenna, uses It is received and transmitted in by RF interfaces 112.Especially, in antenna 110 and the implantation type wireless stimulator device of module 114 On one or more antennas between coupling mechanism utilize electric radiation coupling, rather than inductive.In other words, the coupling is led to Cross electric field and non-magnetic field is carried out.
Coupled by this electric radiation, TX antennas 110 can give implantation type wireless stimulator device 114 to provide input letter Number.This input signal contains energy, and can contain and be used for will put on the electricity of implantation type wireless stimulator device 114 The information that stimulus waveform at pole is encoded.In some embodiments, the power level of this input signal directly determines By using the electric energy being contained in input signal caused one or more electric pulses institute's application amplitude (for example, power, Curtage).In implantation type wireless stimulator device 114 is the component for being demodulated to RF transmission signals, with And for the electrode for the nerve fiber for being delivered to surrounding will to be stimulated.
RF pulse generator modules 106 can be implanted subcutaneously, or it can be worn in vitro.It is external when being worn on When, RF generator modules 106 can be merged in belt or frenulum (harness) design, to allow electric radiation coupling to pass through skin Skin and lower-hierarchy are with to the transmission electric power of implantation type wireless stimulator device 114 and/or control parameter.In both cases, In the internal acceptor circuit energy of wireless stimulator device 114 (or the wireless implantable stimulator device 500 shown in Fig. 5) Enough catch the energy radiated by TX antennas 110 and convert this energy into electrical waveform.Acceptor circuit can also change the waveform To produce the electric pulse for being applied to stimulate nerve fiber.
In some embodiments, RF pulse generator modules 106 can remote control stimulation parameter (that is, put on god The parameter of electric pulse through tissue), and come from based on the RF signals received from implantation type wireless stimulator device 114 to monitor The feedback of wireless stimulator device 114.The feedback detection algorithm implemented by RF pulse generator modules 106 can be monitored by being implanted into The data of stimulator device 114 that formula is wireless wireless transmission, including relevant implantation type wireless stimulator device 114 are just sent out from RF pulses The information of energy and the information of the stimulus waveform about being just delivered to electrode pad that raw device receives.In order in given medical treatment Under the conditions of effective treatment is provided, the system can be adjusted, to provide optimal number to nerve fibre by electro photoluminescence Excited (excitation) or suppress (inhibition).The feedback of closed loop can be used, in the feedback control of closed loop In method processed, the output signal from implantation type wireless stimulator device 114 is monitored and is used to determine for remaining effective Neuronal activation proper level nerve stimulating current, or, in some cases, patient can be in the controlling party of open loop Output signal is manually adjusted in method.
Fig. 2 shows the detailed view of the example of wireless stimulating system.As illustrated, programming module 102 can include using Family input system 202 and communication subsystem 208.User input systems 221 can allow various parameters setting by user to instruct The form of collection adjusts (in some cases, in the form of open loop).Communication subsystem 208 can be via such as bluetooth (Bluetooth) or Wi-Fi wireless connection 104 sends these instruction set (and other information) to RF pulse generator modules 106, and receive the data from module 106.
For example, it can be used in the programmable device module 102 of multiple users, the control unit of such as patient or the volume of clinician Journey device unit, it can be used to stimulation parameter being sent to RF pulse generator modules 106.The stimulation parameter that can be controlled can be with Including impulse amplitude, pulse frequency and pulse width, their scope is shown in Table 1.Herein, term pulse refers to directly Connect the phase (phase) that the waveform stimulated is produced to tissue;The parameter of (being described below) charge balance phase can be by class As control.Patient and/or clinician equally can alternatively control the overall duration and pattern for the treatment of.
Stimulation parameter table 1
Impulse amplitude:0-20mA
Pulse frequency:0-10000Hz
Pulse width:0-2ms
It is each to meet initial program can be carried out to RF pulse generator modules 106 during initial implant procedure The special parameter setting of individual patient.Because medical condition or body itself can change over time, parameter is readjusted The ability of setting is advantageously possible for ensuring the sustained therapeutic effect of neuromodulation therapy.
Programmable device module 102 can be functionally the application of smart machine and correlation.Smart machine hardware can include CPU 206 and the carrier inputted as the touch-screen for being used to handle on graphic user interface (GUI) 204, for handling simultaneously Data storage.
RF pulse generator modules 106 can be via the externally connected TX antennas 110 of wired connection 108.Alternatively, day The located subcutaneously (not shown) of both line and RF impulse generators.
The signal of implantation type wireless stimulator device 114 is sent to by RF pulse generator modules 106 can include electric power And both parameter setting attributes on stimulus waveform, amplitude, pulse width and frequency.RF pulse generator modules 106 are also The radio receiving unit for receiving the feedback signal from implantation type wireless stimulator device 114 can be played a part of.For This purpose, RF pulse generator modules 106 can contain microelectronic component or other circuits, and equipment 114 is sent to for handling Signal generation and handle feedback signal, such as signal from stimulation apparatus 114.For example, RF pulse generator modules 106 can include control device subsystem 214, high-frequency generator 218, RF amplifiers 216, RF switches and feedback subsystem 212.
Control device subsystem 214 can be including the CPU 230 for carrying out data processing, memory sub-system 228 (such as Local storage), communicate with programmable device module 102 communication subsystem of (including receiving stimulation parameter from programmable device module) 234th, pulse-generator circuit 236 and D/A (D/A) converter 232.
Patient and/or clinician can control stimulation parameter setting (for example, passing through using control device subsystem 214 Control is sent to the parameter of the signal of stimulator device 114 from RF pulse generator modules 106).These parameter settings being capable of shadow Ring such as power of one or more electric pulses, levels of current or shape.As described above, can be by using programming module 102 perform the programming to stimulation parameter, and to set repetitive rate, pulse width, amplitude and waveform, these parameters will pass through RF energy Amount is sent to reception (RX) antenna 238 in implantation type wireless stimulator device 214, and it is typically even to receive (RX) antenna 238 Pole antenna (although other types can also be used).Clinician can have locking and/or be hidden in programmable device interface The option of some settings, some parameters are checked or adjust so as to which the ability of patient be defined in, because the adjustment of some parameters can It can need on neuro-physiology (neurophysiology), Nervous System Anatomy (neuroanatomy), the association of nerve modulation View, and the detailed medical knowledge of the safety margins of electro photoluminescence.
The parameter setting received can be stored in local memory subsystem 228 by control device subsystem 214, until The new input data modification parameter setting that self-programming module 102 receives.CPU206 can be used and is stored in local storage Parameter controls pulse-generator circuit 236, and to generate stimulus waveform, the stimulus waveform is in the scope from 300MHz to 8GH Pass through the higher-order of oscillation (preferably between about 700MHz and 5.8GHz, and more preferably between about 800MHz and 1.3GHz) Device 218 is modulated.Caused RF signals may then pass through RF amplifiers 226 to amplify, and then pass through the hair of RF switches 223 TX antennas 110 are given, to reach RX antennas 238 through the depth of tissue.
In some embodiments, the RF signals sent by TX antennas 110 can only be by wireless stimulation apparatus module 114 For generating the electric power of electric pulse transmission signal.In other embodiments, remote measurement (telemetry) signal can also be transmitted To wireless stimulator device 114, to send the instruction of the various operations about wireless stimulator device 114.Telemetered signal can be with By the modulation of carrier signal come send (skin is passed through if in vitro, or, if pulse generator module 106 is implanted Subcutaneously, then through other bodily tissues).Telemetered signal is used to modulate carrier signal (high-frequency signal), and the carrier signal is by coupling Close on implantation antenna 238 and do not disturb the input for power supply to the device received in same stimulator device.One In kind embodiment, telemetered signal and power supply signal are combined into a kind of signal, and wherein RF telemetered signals are used to modulate RF power supplies Signal, and so as to which wireless stimulation apparatus directly passes through received telemetered signal to power;List in wireless stimulation apparatus Only subsystem utilizes the electric power included in signal and explains the data content of signal.
RF switches 223 can be multipurpose plant, such as bidirectional coupler, and the multipurpose plant is with the insertion loss of minimum The RF pulses that amplitude is of a relatively high, the duration is extremely short are passed into TX antennas 110, while synchronously carried to feedback subsystem 212 For two low level outputs;One exports to feedback subsystem 212 and delivers forward power signal, and the wherein forward power signal is The attenuated versions of the RF pulses of TX antennas 110 are sent to, and another another port delivering exported to feedback subsystem 212 is anti- To electric power signal, wherein reverse electric power is the attenuated versions of the reflection RF energy from TX antennas 110.
(when RF signals are just being transmitted to wireless stimulator device 114 during the time in cycle (on-cycle) is connected When), setting RF switchs 223 so that forward power signal is sent into feedback subsystem.In break period (off-cycle) time Period (when RF signals are not just transmitted to wireless stimulator device 114), RF switches 223 are amenable to reception pattern, In the reception pattern, the RF energy and/or RF signals of the reflection from wireless stimulator device 114 are received with feedback Analyzed in system 212.
The feedback subsystem 212 of RF pulse generator modules 106 can include receiving circuit, be come from for receiving and extracting The remote measurement of wireless stimulator device 114 or other feedback signals and/or the reflection RF energy for carrying out the signal that free TX antennas 110 are sent Amount.Feedback subsystem can include amplifier 226, wave filter 224, demodulator 222 and A/D converter 220.
Feedback subsystem 212 receives forward power signal, and the high frequency AC signal is converted into be sampled concurrently Give the DC level of control device subsystem 214.In this manner it is possible to the RF pulses that will be generated in control device subsystem 214 Characteristic compared with reference signal.If having differences (error) on arbitrary parameter, control device subsystem 214 can Adjust the output of RF impulse generators 106.The property of adjustment can be directly proportional to the error for example calculated.Control device subsystem 214 can be incorporated to and other input and the signal amplitude of such as reverse electric power is limited on its Adjusted Option and for various Any predetermined maximum or minimum value of pulse parameter.
Reverse electric power signal can be used to detect the fault state in RF electric power transmission systems.Under ideal conditions, When TX antennas 110 have the impedance of the tissue perfect matching contacted with it, from the electromagnetic wave of the generation of RF impulse generators 106 It is delivered to unblockedly from TX antennas 110 in bodily tissue.But in actual applications, body types in user, worn Significantly changeability is there may be in terms of the positioning of the type and antenna 110 of clothing relative to body surface.Due to The impedance of antenna 110 depends on the relative dielectric constant of lower-hierarchy and any intervention material, and additionally depends on antenna and skin The total linear spacing distance of skin, thus may all exist in any given application in the interface of TX antennas 110 and body surface Impedance mismatching.When such mismatch occurs, it is partially reflected from the electromagnetic wave that RF impulse generators 106 are sent at the interface, And the reflected energy passes through antenna feedback back-propagation.
The RF switches 223 of bidirectional coupler can prevent reflected RF energy back-propagation in amplifier 226, and The RF signal attenuations of the reflection can be made and be sent to feedback subsystem 212 using the deamplification as reverse electric power signal.Instead The high frequency AC signal can be converted into being sampled and being sent to the DC level of control device subsystem 214 by feedback subsystem 212. Then control device subsystem 214 can calculate the ratio between the amplitude of reverse electric power signal and the amplitude of forward power signal.Reversely electricity The ratio between the amplitude of force signal and the amplification level of forward power can indicate that the order of severity of impedance mismatching.
In order to sense impedance mismatching situation, control device subsystem 214 can measure the ratio between reflection electric power in real time, also, According to the predetermined threshold value for the measurement, control device subsystem 214 can change the RF electric power generated by RF impulse generators 106 Level.For example, for moderate reflection electric power, the process of effect can be directed to control device subsystem 214, to increase The amplitude of the big RF electric power for being sent to TX antennas 110, this will be compensation slightly offset from optimal but acceptable TX antennas and body Required for the coupling of body.For the ratio between higher reflection electric power, the process of effect can prevent RF impulse generators 106 from transporting Row and failure code is set to indicate that the coupling of TX antennas 110 and body is very poor or does not have.Such reflection electric power event Barrier situation may also be generated by bad or disconnection the connection with TX antennas.In either case, when the ratio between reflection electric power When more than defined threshold value, it would be desirable to stop RF transmission, because the electric power of internal reflection can cause internals Unnecessary heating, and the fault state means that system can not deliver enough electric power to implantation type wireless stimulation apparatus And thereby can not be that user delivers treatment.
The controller 242 of wireless stimulator device 114 can transmit information signal by antenna 238, such as telemetered signal, To be communicated within its reception cycle with RF pulse generator modules 106.For example, the remote measurement letter from wireless stimulator device 114 Number can transistor circuit switch on and off state during in being coupled on dipole antenna 238 with modulated signal, to open With or disabling generation send corresponding RF trains of pulse (RF needed for outside (or long-range implanted) pulse generator module 106 to Bursts waveform).Antenna 238 can be connected to the electrode 254 with organizing to contact, with provide transmission signal return road Footpath.The data conversion that A/D (not shown) converter can be used to be stored is into can be from wireless stimulator device 114 Inside antenna 238 pulse-modulated signal on the serializing pattern that transmits.Telemetered signal can also use back scattering technology, In back scattering technology, when downlink and uplink signal occurs simultaneously, the upward signal from stimulator to external module can It is overlapping in time, and external equipment is demodulated via transmitting level of power reading to signal.
Telemetered signal from implantation type wireless stimulator device 114 can include stimulation parameter, such as be delivered by electrode To the power or amplitude of the electric current of tissue.By means of coupling a signal to implanted RX antennas 238, feedback signal can be transmitted To RF pulse generator modules 116 to indicate the intensity of stimulation at nerve tract, implanted RX antennas 238 are by telemetered signal spoke It is mapped to outside (or long-range implanted) RF pulse generator modules 106.Feedback signal can include analog- and digital- remote measurement pulse One or both of carrier signal of modulation.The data for measuring characteristic of such as boost pulse parameter and stimulator performance can deposit It is stored in the internal storage device in implanted stimulator device 114, and sent via telemetered signal.The frequency of carrier signal Rate (preferably about between 700MHz and 5.8GHz, and more preferably can about exist in 300MHz to 8GHz scope Between 800MHz and 1.3GHz).
In feedback subsystem 212, telemetered signal can by using demodulator 222 carry out falling tone system, and pass through through Analog to digital (A/D) converter 220 is crossed to be handled to digitize.Then the telemetered signal of numeral can utilize embedded volume Code is routed to CPU 230, has the option reprogramed, signal is translated into tissue with the amplitude based on received signal Corresponding current measurement result.The CPU 230 of control device subsystem 214 can be by the stimulation parameter reported with being stored in local Those parameters in memory 228 are compared, to verify that specified stimulation is delivered to tissue by wireless stimulator device 114.Example Such as, if wireless stimulation apparatus reports the electric current lower than specified electric current, RF pulse generator modules 106 can be increased Level of power so that implantation type wireless stimulator device 114 will have more available electric power be stimulated.Implanted without Line stimulator device 114 for example can generate telemetry in real time with 8Kb/s speed.From implanted stimulator device 114 All feedback data received can record and sampled for the time, so that be stored for pair can be professional by health care The remote supervision system that personnel access is retrieved for trend and statistic correlation.
The sequence of the remote programmable RF signals received by inside antenna 238 can be adjusted in implantable wireless stimulation The appropriate electricity of adjacent tissue to be stimulated is placed in control and be routed to by control subsystem 242 in device equipment 114 The waveform of pole 254.For example, the RF signals transmitted from RF pulse generator modules 106 can be received and led to by RX antennas 238 The circuit for such as waveform adjustment circuit 240 crossed in implantation type wireless stimulator device 114 is handled, to be converted into that electricity can be passed through Pole interface 252 puts on the electric pulse of electrode 254.In some embodiments, implantation type wireless stimulator device 114 includes 2- 16 electrodes 254.
Waveform adjustment circuit 240 can include rectifier 244, and the rectifier 244 is to the signal that is received by RX antennas 238 Carry out rectification.Rectified signal can be fed to controller 242, for receiving from RF pulse generator modules 106 Coded command.Rectifier signals can also be fed to charge balance component 246, and the charge balance component 246 is arranged to Produce one or more electric pulses so that one or more electric pulses produce at one or more electrodes to be caused substantially Zero net charge (that is, pulse is by charge balance).The pulse of charge balance is passed through current limiter 248 and reaches electrode interface 252, the electrode interface 252 depends on the circumstances applies pulse to electrode 254.
Current limiter 248 ensures to put on the levels of current of the pulse of electrode 254 not more than threshold current level.At some In embodiment, the amplitude (for example, levels of current, voltage level or power level) of the RF pulses received directly determines to stimulate Amplitude.In this case, it is possible to particularly advantageously include current limiter 248 to prevent excessive electric current or electric charge to be delivered By electrode, although current limiter 248 can also use in the other embodiment being not the case.Typically, for tool Have some square millimeters of surface area should be restricted (its to fixed electrode, the electric charge of each phase for for the sake of safety The electric charge that moderate stimulation phase is delivered is the integration of electric current).But in some cases, it can be changed to apply limitation to electric current, Wherein maximum current be multiplied by maximum the possibility pulse duration be less than or equal to maximum safe charge.More generally, current limiter 248 serve as charge-limited device, and the characteristic (for example, electric current or duration) that the charge-limited device limits electric pulse causes each phase The electric charge of position is held in threshold level (typically, the safe charge limit) below.
Received in implantation type wireless stimulator device 114 and be enough to generate the stimulation that can exceed the predetermined safe charge limit RF electric power " strong " pulse in the case of, current limiter 248 can volitional check or " reduction " stimulate phase so that the phase Total electrical charge is maintained within safety margins.Current limiter 248 can be current limiting passive component, for once reaching safe current pole The signal of electrode 254 is switched off when limiting (threshold current level).Alternately or additionally, current limiter 248 can be with electrode Interface 252 communicates to disconnect whole electrodes 254, so as to prevent the levels of current of injury tissue.
Reduction situation may trigger the feedback mode control of current limiter.The effect of reduction may promote controller to arteries and veins Rush the sending threshold value power data signal of generator 106.The detection threshold value power signal of feedback subsystem 212 simultaneously demodulates the signal into Send the data of control device subsystem 214 to.The algorithm of control device subsystem 214 can be by specially reducing by RF impulse generators The RF electric power of generation completely cuts through electric power and had an effect under the limiting condition.In this way, if implantation type wireless pierces Swash device equipment 114 and report that it is receiving excessive RF electric power, then impulse generator 106 can reduce the RF electricity to body delivering Power.
The controller 250 of stimulator 205 can be communicated with electrode interface 252, and the pulse of electrode 254 is put on for controlling And the various aspects of electrode setting.Electrode interface 252 can serve as multiplexer and control the polarity of each electrode 254 And switch.For example, in some embodiments, wireless stimulator 106 has the multiple electrodes 254 with organizing to contact, and right In given stimulation, RF pulse generator modules 106 can be led to by the distribution with parameter instruction wirelessly sent Letter arbitrarily specifies one or more electrodes 1) serve as stimulating electrode, 2) serve as refurn electrode, or 3) as inactive, Controller 250 is using the parameter instruction come the setting electrode interface 252 that depends on the circumstances.Physiologically maybe advantageously distributing example As one or two electrode as stimulating electrode and distributes all remaining electrodes as refurn electrode.
In addition, in some embodiments, for given boost pulse, controller 250 can be with coordination electrode interface 252, so that arbitrarily (or according to instruction from pulse generator module 106) division is electric between specified stimulating electrode Stream.This control carried out via electrode distribution and current control can be favourable, because electrode 254 can be in practice Spatially it is distributed along various neuromechanisms, and by the policy selection to stimulating electrode position and is each position The ratio for the electric current specified, total CURRENT DISTRIBUTION in tissue can be modified to optionally activate the neural mesh specified Mark.The strategy of this conduct current can improve the therapeutic effect to patient.
In another embodiment, the time course of stimulation can be manipulated arbitrarily.Given stimulus waveform can To start at time T_start and be terminated at time T_final, and the time course can be in whole stimulating electrodes It is synchronous between refurn electrode;In addition, the repetition rate in the stimulation cycle can be directed to the synchronization of whole electrodes.But controller 250 can by oneself or in response to the instruction from impulse generator 106 coordination electrode interface 252, with specify one or Multiple electrodes subset delivers stimulus waveform with asynchronous time started and dwell time, and each stimulates the repetition in cycle Frequency arbitrarily and can be specified independently.
For example, the stimulator with eight electrodes can be configured with the subsets (referred to as set A) of five electrodes with And the subset (referred to as set B) of three electrodes.Can be configured with its electrode two of set A are used as stimulating electrode, Remaining electrode is as refurn electrode.Set B can be configured as only having a stimulating electrode.Then controller 250 can refer to It is fixed:Set A delivering electric currents are 3mA, the stimulation phase that the duration is 200us, subsequent 400us charge balance phase.Should The cycle is stimulated to be designated as being repeated according to the speed of 60 cycles/secs.Then, for set B, the energy of controller 250 Enough specified current flow 1mA, duration 500us stimulation phases, subsequent 800us charge balance phase.Set B stimulation The repetitive rate in cycle can be set independently of set A repetitive rate, such as it can be designated as 25 cycles/secs.Or Person, if controller 250 is configured as making set B repetitive rate and matching for set A, for such situation, control Device 250 can specify the relative start time for stimulating the cycle so that they are consistent in time, or each other arbitrarily Offset some delay interval.
In some embodiments, controller 250 can be such that stimulus waveform amplitude arbitrarily shapes, or can be in response to coming So done from the instruction of impulse generator 106.Phase is stimulated to be delivered by constant-current source or constant pressure source, it is such Control can generate the signature waveform of static state, for example, characteristic rectangle pulse as constant-current source generation:Current waveform has very steep High and steep rising, the constant amplitude in stimulus duration, and then arrive the very precipitous return of baseline.Alternatively or additionally Ground, the random time that controller 250 can be during phase is stimulated and/or during charge balance phase increase or decrease electric current It is horizontal.Thus, in some embodiments, controller 250 can deliver the stimulus waveform of any shaping, for example, such as triangle Shape pulse, sine pulse or Gaussian pulse.Similarly, charge balance phase arbitrarily amplitude can shape, and similarly, it is preceding Line amplitude shaping can also be entered by leading anodic pulse (prior to boost pulse).
As described above, wireless stimulator device 114 can include charge balance component 246.Typically, for constant current Boost pulse, pulse should carry out charge balance by making the size of cathode current be equal to the size of anode current, this allusion quotation It is referred to as overlap biphasic impulse (biphasic stimulation) type.Charge density be the size of electric current be multiplied by applied it is lasting when Between, and typically with unit uC/cm2To represent.In order to avoid such as pH changes, electrode dissolution and disorganization etc Irreversible electrochemical reaction, net charge should not occur in electrode electrolyte interface, and usually acceptable is to have Less than 30uC/cm2Charge density.Overlap biphasic impulse current impulse ensures that no net charge comes across after each stimulation cycle At electrode, and electrochemical process balance is set to prevent net DC current.Wireless stimulator device 114 can be designed as really Stimulus waveform obtained by protecting has net zero charge.The stimulation of charge balance is considered as by reducing or eliminating in electrode-group Knit electrochemical reaction product caused by interface and there is minimum damaging influence to tissue.
Boost pulse can have the negative electrode phase of negative voltage or electric current, referred to as waveform.Stimulating electrode is stimulating the phase in cycle Between different time can have both negative electrode phase and anode phase.It is enough to stimulate the negative of neighbouring nerve fiber for delivering amplitude The electrode of electric current is referred to as " stimulating electrode ".During phase is stimulated, stimulating electrode serves as current remittance (current sink).One Or multiple other electrodes serve as current source, and these electrodes are referred to as " refurn electrode ".Refurn electrode is placed in tissue There are other places of certain distance with stimulating electrode.When typical negative stimulation phase is delivered to tissue at stimulating electrode When, refurn electrode has positive stimulation phase.During follow-up charge balance phase, the polarity of each electrode can be inverted.
In some embodiments, the use of charge balance component 246 is arranged to electric with stimulating electrode and bodily tissue The block capacitor (blocking capacitor) of series connection, in stimulator circuitry generation stimulate point with to tissue delivery Between the point of stimulation.In this way, it is possible to form resistor-capacitor circuit (RC) network.In multielectrode stimulator, one (or multiple) charge balance capacitor can be used for each electrode, or can make prior to electrode selected element in stimulator circuitry With centralized capacitor.RC network can separate direct current (DC), and still, it can also prevent low frequency ac (AC) from being passed To tissue.The frequency for the RC network cut-off that signal of the frequency below it is substantially connected is commonly known as cut-off frequency, and And in one embodiment, the design of stimulator system may insure cut-off frequency not more than the fundamental frequency of stimulus waveform.At this In this embodiment disclosed in text, wireless stimulator can have its value to measure series resistance and stimulator according to electrode The organizational environment being implanted into carrys out the charge balance capacitor of selection.By selecting specific capacitance, RC in the present embodiment The cut-off frequency of network is for the fundamental frequency of boost pulse or below it.
In other embodiments, cut-off frequency can be selected as the fundamental frequency stimulated or more than it, and this Under situation, non-stationary is can be designed as prior to stimulus waveform caused by charge balance capacitor (being referred to as drive waveforms), its The envelope of middle drive waveforms is change in the duration of driving pulse.For example, in one embodiment, at the beginning of drive waveforms Beginning amplitude is set to initial amplitude Vi, and the amplitude increases in the duration of pulse, until it reaches end value k*Vi. By changing over time the amplitude of drive waveforms, the shape for passing through the stimulus waveform of charge balance capacitor is also changed. The shape of stimulus waveform can be changed in the way of producing in physiologically favourable stimulation.
In some embodiments, wireless stimulator device 114 can produce what is and then received by reception dipole antenna 238 The drive waveforms envelope of the envelope of RF pulses.In this case, RF pulse generator modules 106 can be controlled directly wireless The envelope of drive waveforms in stimulator device 114, and thereby can need not stimulator in itself within energy stores. In this embodiment, stimulator circuitry can change the envelope of drive waveforms or can be directly passed to charge balance Capacitor and/or electrode selection level.
In some embodiments, implantation type wireless stimulator device 114 can be by singlephase drive waveform delivery to electric charge Balanced capacitor, or it can deliver multiphase drive waveforms.(for example, negative sense in the case of singlephase drive waveform (negative-going) rectangular pulse), the pulse includes physiological stimulation phase, and charge balance capacitor is in the phase phase Between be polarized (powered).After driving pulse completion, charge balance function only passes through the passive electric discharge of charge balance capacitor To perform, wherein the charge balance capacitor discharges its electric charge by polarity relative to the opposite tissue of stimulation before. In a kind of embodiment, the resistor in stimulator promotes the electric discharge of charge balance capacitor.In some embodiments, lead to Cross using passive discharge phase, the capacitor can allow the almost electric discharge completely before follow-up boost pulse starts.
In the case of multiphase drive waveforms, wireless stimulator can perform internal switching with by negative sense or direct impulse (phase) passes to charge balance capacitor.These pulses can according to arbitrary sequence come deliver and with variable amplitude and Waveform, to realize desired physiologic effect.For example, can be the charge balance phase of active drive after stimulating phase, with And/or it can be opposite phase that person, which is stimulated before phase,.Before stimulation the phase with opposite polarity can for example with The advantages of reducing the amplitude for making the excited required stimulation phase of tissue.
In some embodiments, the amplitude and timing for stimulating phase and charge balance phase pass through from RF pulses hair The amplitude of the RF pulses of raw device module 106 controls with timing, and in other embodiments, this control can pass through nothing The onboard circuit of line stimulator device 114 (such as controller 250) carries out internal control.In the case of onboard control, amplitude It can be specified or changed by the data command delivered from pulse generator module 106 with timing.
Fig. 3 is the circuit diagram for an example for showing wireless stimulation apparatus 114.The example contains paired electrode, including One (or multiple) cathode electrode (cathode electrode) 308 and (or multiple) anode electrode (anode Electrode) 310, as shown in the figure.When energized, powered electrode creates the volume conduction field of current density in tissue (volume conduction field).In this embodiment, wireless energy passes through (or multiple) dipole antenna 238 receive.At least four diodes are joined together, and the complete of (or multiple) dipole antenna 238 is attached to be formed Ripple bridge rectifier 302.Each diode, 100 microns are up in length, using knot current potential come prevent the flowing of negative current (from Negative electrode is to anode), so as to prevent it from flowing through equipment when the electric current is not above reverse threshold value.For via transporting through group The nerve stimulation that the wireless power knitted is carried out, the natural low potency rate of lossy material may result in low threshold voltage.At this In kind embodiment, the diode rectifier of zero-bias can cause the low output impedance of equipment.Resistor 304 and smoothing capacity Device 306 is positioned to be connected across the output node of bridge rectifier, so that ground connection of the electrode discharge to bridge-type anode.Rectifier bridge 302 include jointed anode to anode and then two branch roads of the negative electrode to the diode pair of negative electrode.Electrode 308 and electrode 310 It is connected to the output of charge balancing circuit 246.
Fig. 4 is the circuit diagram of another example of wireless stimulator device 114.Example shown in Fig. 4 includes multi-electrode control Make and full closed loop control can be used.Wireless stimulator device includes electrod-array 254, in the electrod-array 254, electrode Polarity can be assigned to negative electrode or anode, and for the electrod-array 254, it is alternatively possible to not have to any energy pair These electrodes are powered.When energized, powered electrode creates the volume conduction field of current density in tissue.In this embodiment party In formula, wireless energy is received by equipment by (or multiple) dipole antenna 238.Electrod-array 254 passes through onboard control Device circuit 242 controls, and appropriate position information is sent to electrode interface 252 to set battle array by the onboard controller circuitry 242 The polarity of each electrode in row, and each individual electrode is powered.Lack the power supply to special electrodes will be by the electricity Pole is set in function closed position.In another embodiment (not shown), the size of the electric current of each electrode is sent to Controlled by controller 242.Electric current, polarity and the power state supplemental characteristic for being illustrated as the controller of controller output are sent out Send back to (or multiple) antenna 238, pulse generator module 106 is returned to for telemeter.Controller 242 also includes electricity Flow the function of monitoring and set bit register counter so that the state for the total current extracted can be sent back to pulse hair Raw device module 106.
At least four diodes are connectable to together, and the complete of (or multiple) dipole antenna 238 is attached to be formed Ripple bridge rectifier 302.Each diode, length are up to 100 microns, prevent the flowing of negative current (from the moon using knot current potential Pole is to anode), to prevent it from flowing through equipment when the electric current is not above reverse threshold value.For via transporting through tissue The nerve stimulation that wireless power is carried out, the natural low potency rate of lossy material may result in low threshold voltage.In this reality Apply in mode, the diode rectifier of zero-bias causes the low output impedance of equipment.Resistor 304 and smoothing capacity device 306 It is positioned to bridge the output node of bridge rectifier, so that ground connection of the electrode discharge to bridge-type anode.Rectifier bridge 302 can wrap Include jointed anode to anode and then two branch roads of the negative electrode to the diode pair of negative electrode.Polarity of electrode exports, the He of negative electrode 308 Both anodes 310 are connected to the output for being connect and being formed by bridging.Charge balancing circuit 246 and current-limiting circuit 248 be arranged to it is defeated Go out series connection.
Fig. 5 is the diagram for being implanted into an example of the asic chip 500 of purposes.Chip 500 can utilize high level electricity Resistance device, the bifunctional polymerizable process (double poly process) of Schottky diode and high voltage transistor based on 0.6um are made Make.In some embodiments, chip 500 can manufacture according to 0.5mm width, to be adapted to the pin of such as No. 18.At this In a little embodiments, chip 500 can have up to 10:1 length-width ratio.Chip 500 can be coupled to such as four (4) or eight Platinum-iridium (platinum-iridium) electrode of individual (8) to tissue delivery electric pulse.
Chip 500 includes rectification circuit 502, logic control circuit 504 and drive circuit 506.Rectification circuit 502 is coupled to Differential antennae 512A and 512B.RF input signals can receive at differential antennae, and then be rectified with being detected Amplitude.Rectified signal can give chip 500 to provide electric power.Afterwards, logic control circuit 504 can be from the letter of amplitude detection Waveform parameter is extracted in number.Then, logic control circuit 504 according to the waveform parameter extracted and can be based only upon what is extracted Electric power generates electric pulse.The electric pulse generated can be then supplied to drive circuit 506, and the drive circuit 506 includes Charge balancing circuit and current monitoring circuit.Drive circuit 506 is coupled to electrode interface 508A to 508H, and each electrode interface is equal It is coupled to corresponding electric loading 509A to 509H.Electric pulse is then delivered to each electrode, i.e. 510A to 510H.
In detail in this figure, diode bridge circuit 514 is introduced into, with to being received with difference form from differential antennae 512A and 512B Input signal provide full-wave rectification.Full-wave rectification can utilize the RF input signals received at differential antennae 512A and 512B Positive part and both negative parts.
In some embodiments, the dipole antenna in differential configuration can be embedded into wireless implantable stimulator device In.Dipole antenna receives electric power, serial communication and stimulus waveform from the external external emitters of patient are placed in.Dipole antenna is straight The flexible PCB being connected in succession in embedded implantable stimulator device, the implantable stimulator device include separate member and core Piece 500.Chip 500 can include the wireless serial order receiver of the multiplex function with up to eight passages.
Rectification can give the remainder of chip 500 to power.In some cases, VDD circuits 518 and earthed circuit 519 Capacitor C1 520 is coupled to, to provide stored charge.Stored charge can usually power to chip 500. In some embodiments, diode can be used to be powered from Vrect supply VDD logics.If fruit chip 500 is active, and Voltage VDD drops to below 1.8V, then chip 500 can enter " recovery of VDD low-voltages " pattern.In this state, any/ Whole high-side driver will temporarily be covered as (ridden to) Hi-Z, and the driver of all downsides would is that Hi-Z. Once VDD is back to more than 3.0V state, and in operational mode, then driver will return to them and be previously programmed The state gone out.
The output for carrying out self-rectifying circuit 502 is coupled to logic control circuit 504.As illustrated, logic control circuit 504 Logic control/state machine 522 and timer/oscillator 524 can be included.Logic control/state machine 522 can be coupled to passage Selector 526.
The RF input signals received can include the waveform parameter for histio-irritative electric pulse.The RF received is defeated The polarity set information for the interface for being used to set each electrode can be included by entering signal.
With reference to figure 6, the figure shows the sequence chart during the operation of chip 500.Especially, pulse train 600 includes Pulse section.Each section can continue an interval time (an epoch time) (being shown as Tepoch).Each section Two parts can be included, i.e. initial part and subsequent stimuli part.In more detail, initial part refers to that wherein RF is inputted The electric power included in signal is acquired and electric charge is pumped to part in capacitor C1 520.Initial part can be with persisted moniker For Thigh period.Initial part can be referred to as communication initialization pulse 602A and 602B.Part is stimulated to correspond to part 604 and it encoded to the waveform parameter of electric pulse and the polarity set information of electrode interface serial can be contained disappear Breath.In some cases, part 604 can come across the first section of sequence 600, for configuring electric pulse and polarity set. In the case where lacking electrification reset event, once complete initialization, it is possible to the configuration of fixed waveform parameter and polarity set Information.
Chip 500 can tolerate the serial message between embedded power pulse.For example, transmitter can be by sending 2ms " communication initialization pulse " (Thigh) and the subsequent 2ms periods unregulated power transmission (Tmsg-Thigh) carry out initialization string Row communication information.In this example, data transmission can closely follow the delay of the 2ms afterwards and start at time Tmsg.Can To be calibrated by measuring the length of the head byte in the data flow transmitted to carry out bit timing (Bit timing).
In some embodiments, serial data can use the form based on IrDASIR forms.This coded format hair Send the pulse that the position wherein to be sent is " 0 ".It is set in place in the position time of " 1 ", pulse can not be sent.Each pulse It can be the 3/16 of a time, but the width can be adjusted if desired.This form may need less power, And serial line data sending therefore can allow for be run with relatively low baud rate.
In the serial data communication of example, data can be asynchronous as the byte with 1 start bit and 1 stop position Transmission (for example, when transmitting 10,8-n-l forms bear identical expense, but only 8 carrying data in 10 with RS-232, and Another two are protocol overheads).LSB can be the first transmitted data bit.For the data of 7 bytes, that is transmitted adds up It is 70 altogether.10 in these are protocol overheads, and 60 in these can be used for carrying data.In this example In, there is no extra delay between byte, data flow is continuous.
In this example, serial baud rate is 19200.Serial message can have the regular length of 7 bytes, and 7 bytes include 1 Head byte, 5 byte of payloads and 1 verification and (checksum) byte.Byte of payload usually can be right The polarity set of each electrode interface, the polarity set of electrode driver for each electrode, the width of each electrode driver Degree level etc. is encoded.Verification and byte usually contribute to ensure message integrity.
Head byte is used to identify the starting of data-message.In some embodiments, it can be predetermined to be value OxAA. In these embodiments, before correct head byte is received, head byte can be dropped.Head byte can also by with To calibrate internal oscillator, the internal oscillator is powered by the wireless energy being stored on VDD.Some embodiments can be with At regular intervals (being 104 μ s between transmission) provide for 10 bit sequences On-Off-On-on/off-on/off-on/off- The unique texture of (on-off-on-off-on-off-on-off-on-off) is closed as fixed timing mark.
In some embodiments, head byte can include the address of electrod-array.For example, the 7th of the 1st byte can be with Lead address (Lead Address), for distinguish in two possible electrod-arrays be expected message an electrode Array.Electrod-array can only implement the message matched with its allocated lead address.If passage A lead receives pin To passage B message, then the content of registers that state machine can refuse new message and maintenance stores before.In this example, Each electrod-array can have 0 or 1 address, and the address can tie up (pin during the manufacture of lead by pin Strapping) determine.
Fig. 5 is returned to, in some embodiments, when receiving RF electric power, AM detectors 516 can export logical zero. In some embodiments, the preposition amplification of low-voltage data-signal or the limitation of high voltage data-signal can expand AM detections The working range of device 516.Just because of this, 100mV or bigger signal will be detected.AM detectors 516 can to The serial stream of 19200 bauds transmission is decoded.The input of AM detectors 516 can be in the inside of chip 500, and its feature It is to use with high-frequency (869-915MHz).
AM detectors 516 can usually handle the place between 50mVpp-15Vpp power supply levels (peak value to peak value) In the rectified signal in nominal range.AM detectors 516 can include preamplifier, for vising the letter of the higher amplitude of oscillation Number, shunk (collapsing) or fold-down (folding down) without exporting.Preamplifier should have enough Gain and low skew parse 100m Vpp data-signal.
AM detectors 516 can detect the serial data encoded using IrDA (SIR) form.Gbps serial receiver It can be included in AM detectors 516, and can be by the data conversion of serial form into parallel form.Gbps serial receiver The operation of hardware can be controlled by clock signal, and the clock signal is run according to the multiple of data transfer rate.In some implementations In mode, the state of the input signal that receiver can be tested in each clock pulses is to search for start bit.It is if obvious Start bit is effective, then this represents the beginning of fresh character.Otherwise, the position is considered as stray pulses or power pulse and quilt Ignore.After another time has been waited, the state of circuit is sampled again and caused level is entered by clock Enter in shift register.
After it have passed through the bit period (bit period) of character length requirement, the content of shift register can be Used in reception system.In addition to signal of communication, the timing system that is not shared between Gbps serial receiver and transmitter.
Gbps serial receiver on chip 500 can receive and cache seven (7) eight bit words.If verification and matching Success, the data contained by these words should be used to be programmed the control register in LMI927.If verification and matching Unsuccessful, then data will be ignored, and receiver continues to monitor effective data.If the byte received is discontented with Sufficient IrDA (SIR) framing parameter (framing parameters), then Gbps serial receiver will reset and prepare to receive new Word.This will allow serial receiver by receiving spurious signal or stimulating power pulse fast afterwards to be activated in error Reply immediately position.If any individual byte is unsatisfactory for timing parameters, Gbps serial receiver need not wait until to receive own completely Word.
Before one group of effective serial data is received, chip 500 can remain non-configuration status, and (all high sides are defeated Go out and be in triode mode for Hi-Z (high-Z), downside output).It is worth noting that, in some embodiments, if set Standby locking bit (Device Lock bit) is set, then serial receiver possibly can not work.
Logic control/state machine 522 can be synchronized by timer/oscillator 524.This can synchronously make logic control System/state machine 522 can extract waveform parameter and polarity set information from part 604 and they are decoded.Logic Then control/state machine 522 can create one or more electric pulses according to waveform parameter.Logic control/state machine 522 is also Electrode interface 508A to 508H polarity can be set according to the polarity set information extracted.
The output of logic control/state machine 522 can be coupled to drive circuit 506, and the drive circuit 506 is put down including electric charge The feature of weighing apparatus, shunt resistance device and current mirror.Especially, drive circuit 506 includes being configured to couple shunt resistance device To the shunt resistance controller 530 of handover network 532.The coupling can strengthen default electrical resistances device by delay controller 533 531.Delay controller can include the insertion of corresponding shunt resistance device at the end of electric pulse the circuit of stimulating electrode, to subtract The size of Small leak electric current.
Some embodiments can include variable shunt resistance device, to control the boost pulse from block capacitor Electric discharge.In these embodiments, initial serial order contains the instruction of the setting value for shunt resistance device.For example, operation Personnel can be selected between four kinds (4) different setting.Internal shunt device is configured such that during boost pulse it Be off, and they are engaged after the pulse.
The engagement of resistor can postpone to carry out after the application of electric pulse.Timer is put for postponing block capacitor The beginning of electricity.Timer can initialize during boost pulse, and it starts its delay at the end of phase is stimulated.This prolongs There is the fixed duration late, and can be independently of stimulation amplitude, repetitive rate and pulse width.
In some embodiments, electric pulse is stimulated to be delivered to specific electrode by handover network 532.In order to two Polarity is planted to deliver electric pulse, handover network is coupled to current source DAC534A and current remittance DAC 534B.It is as illustrated, electric Stream source DAC 534A include the dynamic range of 7, and are coupled to commutating voltage Vrect 517.Current source DAC 534A are adjusted It is set to the polarity of, institute's connection electrode positive.Similarly, current source DAC 534A include the dynamic range of 7.Current source DAC 534A are called, and the polarity of institute's connection electrode is set to negative.
In the case where emulation has the function that the background of drive circuit of shunt resistance device and handover network, Fig. 7 A show protrusion Model the example chip model 700 of component.In this arrangement, H bridgings with corresponding electrode interface and capacitor together Simulate specific electrode.This arrangement have studied the direct coupling of H bridge power supplys.As illustrated, each H bridges include a pair Coupling capacitor 709A and 709C, and tissue load 709B.Each gate circuit on H bridges includes full transmission gate switch 710.The full transmission gate switch 710 of example includes the transistor gate 710A and 710B being mirrored into.
Buffer 507 simulates the drive for current source DAC 534A and current remittance the DAC 534B for being coupled to specific electrode interface The effect of dynamic transistor.Gate 506 simulates the typical logic door for storing and H bridges control, for example, for configuring each electricity The polarity set of pole.Parallel regulator 530 simulates the effect of shunt resistance controller 530.Resistor 704 and the mould of capacitor 703 Intend storage C1 520 pay(useful) load and VDD 518.Especially, resistor 704 represents application specific integrated circuit (ASIC) typical DC electric current draws load.Diode bridge 514 simulates the effect of commutation diode bridge.
Based on this model, various electric signal parameters can be modeled before asic chip is by manufacture.Show at one In example, the stimulus waveform after rectification is expressed as Vstim, Fig. 7 B show desired Vstim waveforms (on passage 1) and RF Input signal (on passage 2).As shown, substantial amounts of detailed performance can be emulated in the design phase.Other In example, H bridge transmission gates between different methods (for example, different application with shunt resistance device) can be compared On/off leaks.
Chip 500 can include monitoring electrification reset (POR) circuit, and the circuit is designed to reach in system voltage To appropriate horizontal and equipment is remained reset before having stablized.When supply voltage drops to below lowest operational level When, por circuit is also used as the protection circuit for preventing insufficient (brownout) situation of electric power.Por circuit design be so that it Reset and enable and include appropriate sluggishness (hysteresis) between level, to prevent from starting under normally operation electrifying condition Surge (inrush) electric current promotes device to reset.Por circuit performs as needed, with the situation of all power fluctuations (bag Include High-speed transient and the situation of slow voltage change ratio) under maintain correct chip functions.If desired, por circuit can Ticking event (tick event) including house dog (watchdog) timer, to ensure the correct operation of chip 500.
As shown in figure 5, each electrode interface is coupled to corresponding capacitor 509A by 1909H.For the mesh of blocking , these capacitors are arranged to series connection.Capacitor is in the signal chains before stimulating electric pulse to be delivered to electrode Finally.In some embodiments, nominal series capacitance can be 3.0/ μ F at each electrode.Each capacitor and then coupling Respective electrode 510A to 510H to 8 electrode stimulating device equipment.As noted, it is defeated can be coupled to 8 electrodes for chip 500 Go out.Each electrode output can be configured to source and go out (sourcing), import (sinking) or be Hi-Z.
With reference to figure 8A, the digital-to-analogue mirror image of example is shown for chip 500.The example highlights current mirror feature.One As, multiple DAC with individually addressable and controllable current encoded will increase ASIC register space and design Complexity and tube core (die) area.On the other hand, there is the DAC less than available channel coulomb may be needed to count (coulomb counting) limits the electric current by individual passage.In the case where DAC passages are fewer than electrode, pass through individual The electric current of electrode can increase for more low-impedance passage.
In some embodiments, the single current with scaled least significant bit (LSB) current value is oriented to DAC is used to generate main bias current.In these embodiments, electric current is not had to be wasted in current mirror.In main biasing After electric current generation, then DAC current is mirrored onto individual electrode, current mirror image ratio 1:N.N can be based on conduct current DAC Matching is required to select.For example, N can be in the range of 10.The LSB sizes of individual electrode can be 100uA.In the feelings of 7 Under condition, the full dynamic range of driving current can be up to 12.7mA.
Embodiment shown in Fig. 8 A shows double DAC methods, and the wherein current source of mirror image bridges eight (8) electrodes.It is brilliant Body pipe gate circuit 803A is transistor gate 803B according to 1:The duplicate of 1 transistor mirror picture.Digital-to-analogue conversion (DAC) circuit 802A represents to push away DAC (push DAC), and can correspond to current remittance.Meanwhile DAC 802B represent to draw DAC (pull DAC), and it can correspond to current source.Logically, DAC 802A and DAC802B can correspond respectively to DAC 534A and DAC 534B, as shown in Figure 5.In order that current mirror mismatch and current waist minimize, the current remittance DAC of N sides is used for this should With.In the configuration, individual passage is enabled with complementary signal.Especially, (CH0 is just by complementary transistor 804A for passage 0 Pole) and 804B (CH0 negative poles) enable.Transistor gate 804A is coupled to Vrect 517, and transistor gate 804B It is coupled to VDD 518.Circuit 805 represents tissue load and block capacitor on lane 0, similar to shown in Fig. 7 A Circuit 709A to 709C.In some embodiments, in addition to resistive component, the tissue load of passage 0 can also include electricity Capacitive component.Equally, complementary transistor 806A and 806B represents the positive polarity of the tissue load 807 for driving passage 1 respectively Arrangement and negative polarity arrangement.This embodiment show 8 sides, current remittance DAC configurations, current monitoring is directed in the configuration Each passage of the 8 channel electrode leads coupled is replicated.For example, the drive arrangement of passage 7 by complementary transistor 808A and 808B and tissue load 808 represent, as shown in Figure 8 A.It is worth noting that, in the N sides embodiment, can be directed to every Individual current remittance configures three kinds of states, i.e. current remittance pattern, cut-out equipment (shutdown mode) and the conduct of controlled (being mirrored into) Triode mode switch has turned on equipment.As illustrated, each passage also includes ON switch.For example, passage 0 includes CH0_ ON is switched, and passage 1 and passage 7 include CH1_ON and CH7_ON and switched respectively.
Fig. 8 B provide the example timing of the waveform in embodiment of above.Trace 812 is shown in ON switch CH0NWhen the stimulation part of rectified RF input signals seen, and trace 814A is shown in ON switchWhen see The waveform arrived, and trace 814B shows the waveform seen in ON switch CH0_ON.The connection resistance of triode mode May not be crucial, because it is connected during back discharge rather than during stimulus modality.
The conduct current (current source and eight current mirrors) being implemented may limit the electric charge of each phase, make Electric pulse is obtained to be applied in safe range for stimulating.In some embodiments, external emitters can specify that to pulse The limitation for being serially written levels of current of width and amplitude.Using the parameter of these regulations (or restriction), it can prevent patient from using Family request is unsafe per phase electric charge, because patient user has limited parameter selection option.In these embodiments, When stimulating part not come across in rectified RF input signals, current DAC is probably inactive.
In order to prevent single electrode source from going out or import the more electric charges of electric charge more acceptable than each phase, current control side Method can be used in high and low both sides.In conduct current stimulating method, high side is to be connected to the single current source of Vrect voltages DAC, there is current mirror for each electrode.Downside is current remittance DAC.Each conduct current DAC can include 7 conversions Device.Because LSB corresponds to 100 μ A, maximum current can be defined as each electrode 12.7mA.DAC principal current reference It can be exported from Vrect.Follow current mirror (Following-current mirrors) can obtain from Vrect.In downside Similar approach can be used to prevent single electrode from importing excessive electric charge.
The passive implantable nerve stimulator for not having board mounted power or inductor loop can be miniaturized to be suitable for minimally invasive The compact form factor of implantation.In some embodiments, the nerve stimulator of wireless power can be suitable for 13G or smaller Pin equipment inner chamber.In order to promote the delivering through inner chamber, passive implantable nerve stimulator can be according to string shape (length pair The aspect ratio of height/width is big) manufacture, for example, height/width is in below 2mm and length is tens of milliseconds.
Fig. 9 A- Fig. 9 B show an example of the flexible circuit 900 of implantable nerve stimulator equipment.In this example In, flexible circuit 900 has four sides, i.e. 901A to 901D.Nearly sophisticated 901A and remote sophisticated 901C is measured as height and is 1.1mm.Two sophisticated thickness can be less than 1.1mm.Horizontal side 901B and 901D is measured as long 52.975mm.Circuit 900 is pressed Be shaped and configured according to form of the aspect ratio more than 50 so that circuit 900 is flexible, with adapt to bending in implantation process and Distortion.
Flexible circuit 900 includes RF ports 902A and 902B, and each RF ports are both configured to be attached to antenna.In the above In the embodiment discussed with reference to Fig. 3-Fig. 4, antenna (such as antenna 238) can be configured as differential antennae.Show at one In example, component groups 904A, 906A, 904B and 906B are installed between RF ports 902A and 902B.In this example, component groups 904A and 906A is coupled to RF ports 902A by signal traces, and the signal traces are thin to being enough in the inner chamber through pin equipment Retain pliability under the background of et al. Ke.It is worth noting that, the copper used in signal traces can cause rigidity, and copper dosage Reduction the pliability of circuit 900 can be improved (by the size for reducing signal traces).In some embodiments, can be right Copper tracing wire carries out systematic testing, to determine to be suitable for conduct electric current while retain flexible size, such as copper tracing wire width Can be 3mm-1mm.For example, rigid test is carried out to the copper tracing wire of various thickness, to determine imitating implantable nerve stimulation Integrality is bent and kept after the pliability circulation (flexible cycling) for the environmental pressure that device may be subjected to Ability.Meanwhile the resistance of these traces is confirmed as being applied to (for example, having acceptable impedance) conduction electric current.Component groups 904A and 906A includes rectification circuit component and waveform adjustment component, as discussed above in association with Fig. 2, Fig. 3, Fig. 4 and Fig. 5 's.As illustrated, RF ports 902A and component groups 904A near-end interval 1mm.Equally, component groups 904B and 906B are via thin Signal traces are coupled to RF ports 902B, to realize mechanical flexibility while keep electric conductivity.Component groups 904B and 906B include Similar component (such as diode, resistor and capacitor).Component groups 904B distal end is spaced apart 1mm with RF ports 902B. As illustrated, the gap between component groups 906A and 906B is about 0.75mm or following.In addition, each component groups, which have, is short to foot With the flexible lateral length of stick holding circuit 900.For example, the length of component groups is confirmed as typically in below 3mm.By by The length of cumulative plus particular elements group, it is flexible (for example, can until finding flexible circuit 900 no longer for implantation process Whether stimulator for implantation equipment remains able to guide flexibility with angle of bend when through the pin mouth of implanting needle entering in epidural space Circuit) make the determination.The threshold length and then it is confirmed as below 3mm or left and right.In addition, the height of these components is general Between 0.6mm and 0.8mm, to retain the function and pliability of whole circuit.
Flexible circuit 900 also includes proximally component groups 908,910 and 912 of the direction to distal direction provided in series.Structure Part group 908 is spaced apart 1mm with RF ports 902B in a distal direction.Usually, component groups 908,910 and 912 it is spaced apart not More than 0.75mm.As discussed above in association with Fig. 5 and Fig. 7 A, component groups 908,910 and 912 generally include voltage-regulation Device, current distributing resistor and waveform adjustment component.Every group of component can also include the capacitor that electric capacity is not less than 1 μ F.The electricity Appearance scope, which usually causes capacitor being integrated into asic chip 914, becomes less feasible.Implement on asic chip 914 Capacitor will be constructed with two conductor plates, have dielectric layer between the two conductor plates, this is compared with discrete capacitor More surface areas may be needed.In some cases, the electric capacity generated on asic chip can be in 10E-15 methods/square micro- The magnitude of rice and flour product.In these cases, the capacitor of the 1 μ F on asic chip may result in thousands of square millimeters of core Piece footprint, the size are unpractical for application.
Asic chip 914 is installed on flexible circuit 900, from the about 1.25mm of component groups 912.In some embodiments In, asic chip 914 is no longer than 3mm, to allow the sufficiently large pliability of circuit 900.The width of asic chip 914 can be small In 0.5mm.Fig. 5 and Fig. 7 A can be combined to find the example arrangement of asic chip 914, as discussed above.Asic chip 914 typically utilize the RF electric power extracted from the Part I of the RF pulses received and second from the RF pulses received The waveform parameter and polarity information extracted in part.Asic chip 914 can be by using the RF energy extracted and according to institute The waveform parameter of extraction configures electrode interface to provide stimulus waveform according to the polarity information extracted.These electrodes Interface is coupled to component groups 916A to 916H, as discussed below.
Flexible circuit 900 also includes eight component groups 916A to 916H (proximally arriving distal end).These component groups and ASIC Chip 914 is spaced 1.25mm, and can usually include capacitor.Capacitor in each component groups can separate stimulus wave DC components in shape, to keep zero net electric charge in the nerve fiber being upset.Usually, the increase of electric capacity can cause to improve DC barriers.The size and pliability limited of flexible circuit 900 can become unavailable big capacitor.Configured in one kind In, multiple capacitors can be stacked the electric capacity rise so that component groups.As it was noted above, as the number of components increases, component The rigidity of group can increase, and this can make the rigidity for implantation process of circuit 900 too high.Some embodiments can include increase Capacitors count in each component groups is simultaneously it is then determined that whether the rigidity of circuit 900 can hinder implantation process (to mean to fit It should be subcutaneously implanted and be implanted into by the spinal cord of epidural space).In some cases, rigidity is bent in flexible circuit by circulation By qualitative determination during test, in the circulation flexure test flexible circuit by implantable nerve stimulation apparatus in implantation process The bending and distortion that may be undergone.Component will depart from or fracture (snap).In other cases, rigidity is by entering and reaching Determined to the mobility (maneuverability) of the equipment of physiological location, for example, in the spoonbill mouth (spoonbill of pin Mouth) bow out place.If excessively firm, equipment will not form angle or fracture in this process.Spinal cord stimulation (SCS) application may may require that the standard method of 45 degree of angular distortions, and this is probably a kind of harsh application.In this application, closely Sophisticated 901A can be towards remote sophisticated 901C bending (or in turn) so that nearly sophisticated 901A and remote sophisticated 901C are formed sharply Up to 45 ° of angle.In the state of stretching, as shown in Fig. 9 A to Fig. 9 B, nearly sophisticated 901A and remote sophisticated 901C form 180 degree Angle.Even in this harsh SCS applications, when nearly sophisticated 901A is bent to be formed sharply up to 45 ° towards remote sophisticated 901C Angle when, also without component depart from flexible circuit.The length of each component groups so as to be determined to be in about below 3mm, and And the gap between component groups is confirmed as at least 0.75mm.If the gap is longer, pliability will increase, but should Design may be excessively grown so that not being suitable for human body.
Flexible circuit 900 supports eight (8) electrode interface pads.As illustrated, electrode interface 918A to 918H distinguishes coupling Electric pulse can be discharged to stimulate the electrode of nerve fiber by being connected to.As illustrated, each electrode is so as to being connected to capacitor Component groups.Flexible circuit 900 also includes the solder pot pad (not shown) at remote sophisticated 901c, to be incited somebody to action in welding process Tension force is localized so that the surface mountable member on flexible circuit 900 will not be shifted due to the heating of solder.
It is described above numerous embodiments.It will be appreciated, however, that various modifications can be carried out.Therefore, Qi Tashi The mode of applying is belonged within the scope of following claim.

Claims (15)

1. a kind of flexible circuit, including:
Substrate;
One or more radio frequencies (RF) port on the substrate, the port are configured as being coupled to RF antennas, the RF Antenna is configured as receiving the RF pulses from peripheral control unit equipment;
One or more groups of components on the substrate, one or more groups of components are configured as from the RF pulses received Extract RF energy and deliver the electric pulse for being applied to stimulate nerve fiber;
Integrated circuit (IC) component on the substrate, the IC components are configured as being based only upon extracted RF energy next life Into the electric pulse suitable for stimulating nerve fiber;And
Wherein described substrate, one or more groups of components and the integrated circuit member are resized and are located in On the substrate so that the flexible circuit is bent during implantation within a patient, without becoming inoperable.
2. flexible circuit according to claim 1, wherein the substrate is resized is not more than No. 13 to fit through Pin.
3. flexible circuit according to claim 1, wherein the substrate has the aspect ratio not less than 50.
4. flexible circuit according to claim 1, wherein every group of component all includes the component that width is not more than 3mm, and Wherein described component, which is spaced apart, is not more than 0.75mm.
5. flexible circuit according to claim 4, wherein the height of the component in 0.6mm between 0.8mm.
6. flexible circuit according to claim 4, wherein every group of component and the IC components interval 1.25mm or bigger.
7. flexible circuit according to claim 1, wherein at least one component includes the capacitor not less than 1 μ F.
8. flexible circuit according to claim 1, wherein one or more groups of components include multiple capacitors.
9. flexible circuit according to claim 1, wherein component groups are configured as first from the RF pulses received Extraction RF energy in point, and stimulus waveform parameter and polarity set are extracted from the Part II of the RF pulses received, and And wherein described Part I is prior to the Part II.
10. flexible circuit according to claim 9, wherein the IC components are arranged to:
Configure the electrode setting according to the polarity set extracted.
11. flexible circuit according to claim 9, in addition to:
It could attach to the one or more electrode interfaces for the electrode that will be placed in around nerve fiber.
12. flexible circuit according to claim 11, wherein one or more groups of components are configured as suitable for thorn The electric pulse for swashing nerve fiber is delivered to one or more of electrode interfaces so that the electric pulse is according to from being received RF pulses the Part I in the stimulus waveform parameter extracted stimulate nerve fiber.
13. flexible circuit according to claim 11, wherein one or more of electrode interfaces be configured as according to from The polarity set that is extracted in the Part II of the RF pulses received adjusts polarity set on the electrodes.
14. flexible circuit according to claim 1, wherein when the first end of the flexible circuit is towards the flexible electrical When the second end on road is bent so that the first end is formed sharply up to 45 ° of angle with the second end, not in institute The component stated on flexible circuit comes off from the substrate.
15. flexible circuit according to claim 1, in addition to:One or more solder pot pads, the solder pot pad It is configured as that tension force localizing in welding process so that the surface mountable member on the flexible circuit will not be due to weldering Connect heat and shift.
CN201680031309.4A 2015-04-17 2016-04-18 Flexible circuit for implantable devices Pending CN107614057A (en)

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