WO2000016851A1 - Multiple channel nerve stimulator - Google Patents
Multiple channel nerve stimulator Download PDFInfo
- Publication number
- WO2000016851A1 WO2000016851A1 PCT/US1999/021386 US9921386W WO0016851A1 WO 2000016851 A1 WO2000016851 A1 WO 2000016851A1 US 9921386 W US9921386 W US 9921386W WO 0016851 A1 WO0016851 A1 WO 0016851A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- channel
- stimulator
- nerve
- power supply
- anode
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36142—Control systems for improving safety
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
- A61N1/0556—Cuff electrodes
Definitions
- the present invention relates generally to the biomedical arts, and, in particular, to an improved multi-channel device which finds particular application in introducing a string of artificially generated antidromic pulses on the nerve trunk for collision blocking orthodromic pulses moving in the opposite direction along the nerve trunk and will be described with particular reference thereto. It is to be appreciated, however, that the invention may have broader applications and may apply electrical signals on nerve trunks for other purposes.
- a common blocking technique was the application of DC currents on the nerve trunk.
- DC currents can be expected to cause nerve damage.
- others have suggested using an oscillating current such that the induced electrical current flowed alternately in both directions along the nerve trunk.
- high frequency stimulation blocks the passage of nerve signals therethrough.
- high frequency stimulation may, in effect, be overdriving neuromuscuiar junctions and depleting the neurotransmitter at the terminal end. That is, rather than blocking the passage of nerve stimuli on the nerve fiber or axon, the high frequency stimulation techniques may be overworking the nerve terminal to the point of exhaustion causing a failure of proper functioning.
- Yet another blocking technique utilized a three electrode cuff which included a dielectric sleeve having a passage through which the nerve trunk passes. Three annular electrodes were arranged within the sleeve. A cathode was positioned near the center of the passage and a pair of anodes were positioned to either side. A signal generator was connected with the electrodes to apply an electrical pulse train that induced antidromic pulses on the nerve trunk. Each pulse of theoptione train included a rapid rise to a preselected amplitude, a 100 to 3000 microsecond plateau, and an exponential decay back to zero. This pulse train induced artificially generated antidromic pulses on the nerve trunk which traveled unidirectionally in the opposite direction to the normal pulse fiow.
- the antidromic blocking pulses were utilized to block stray excitation pulses moving toward a paralyzed patient's spastically contracted sphincter muscle over which control had been lost, the stray orthodromic pulses would cause undesired activation of the muscles of micturition.
- U.S. Patent No. 4,608,985 provides a system for selectively blocking orthodromic action potentials passing along the nerve trunk.
- the system includes an electrode cuff including a cathode disposed around the nerve trunk and a dielectric shield disposed encircling the electrode and the nerve trunk to both sides of the electrode.
- An anode is electrically associated with body tissue such that electrical current flows from the anode through the body tissue and nerve trunk to the cathode.
- a signal generator is operatively connected with the cathode and anode for cyclically generating electrical pulses.
- Each pulse cycle includes a first polarity pulse which rises abruptly to a first preselected amplitude, retains the amplitude for a preselected duration, and decays smoothly from the amplitude.
- Each cycle further includes an opposite polarity phase whose leading edge is a smooth continuation of the first polarity pulse decaying trailing edge.
- the opposite polarity pulse rises smoothly to a magnitude whose absolute value is less than the first polarity pulse magnitude and which is too low to trigger action potentials.
- the opposite polarity pulse is substantially longer than the first polarity pulse such that the charge flow during the first and opposite polarity pulse is opposite but generally equal.
- the major obstacle which makes it difficult to transform this system from a percutaneous to an implantable device lies in the fact that the circuitry for providing stimulation to each sacral root must be kept isolated. This isolation can be maintained by the use of separate power supplies (batteries) for each channel. Thus, in a device which stimulates six sacral roots, the system employs six separate batteries to provide six isolated output channels. A direct translation of this percutaneous device means that an implantable device must also use six batteries in order to achieve isolation. The use of six batteries would increase the size and weight of an implantable device such that the device may be impractical.
- the present invention provides a new and improved device which can overcome the above referenced problems. SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide a device having electrical isolation between output channels of a multiple channel nerve stimulator. It is also an object of the present invention to provide a circuit design for a multichannel nerve stimulator which minimizes leakage currents between channels.
- a novel multiple channel nerve stimulator having a single power supply, a plurality of channels coupled to the power supply, and control means which reduces the resistance in the active channel such that any leakage current to the inactive channels is minimized.
- FIG. 1 is a graphic representation of the quasitrapezoidal waveform generated by the stimulator circuitry of the present invention
- FIG. 2 is a perspective view showing an electrode cuff to be used with the present invention
- FIG. 3 is a block diagram of a multiple channel nerve stimulator circuit according to the present invention.
- FIG. 4 is a block diagram of the stimulator circuit of FIG. 1 showing the controlling circuitry and one channel of the device in greater detail;
- FIG. 5 is a timing diagram showing the outputs of the multiple channels of the device according to the present invention
- FIG. 6 is a block diagram of an alternative embodiment of a multiple channel nerve stimulator circuit according to the present invention.
- FIG. 7 is a block diagram of the stimulator circuit of FIG. 6 showing the controlling circuitry and one channel of the device in greater detaii; and FIG. 8 is a timing diagram showing the outputs of the multiple channels of the device of FIG. 6.
- Waveform 10 which has been proven to be very effective in the stimulation of sacral nerve roots without undesired muscle activation or tissue damage.
- Waveform 10 which is sometimes referred to as a quasitrapezoidal pulse, includes a first portion 12 having a first polarity or current direction and a second portion 14 having a second or opposite polarity or current direction.
- First portion 12 includes a leading edge 16 which rises rapidly to a preselected amplitude which reaches a plateau phase or portion 18 which is maintained for a predetermined duration. After this predetermined duration, plateau phase 18 decays exponentially along on exponential decay portion 20, which reaches zero at a crossover point 22.
- the current changes polarity and increases in amplitude along an exponential current increase portion 24.
- the one polarity decay portion 20 and the opposite polarity increase portion 24 have a smooth discontinuity free transition.
- the opposite polarity increase portion reaches a steady state amplitude 26 and holds the steady state amplitude for a steady state duration 28 until the beginning of the next cycle.
- the opposite polarity waveform 28 may/may not quickly return to zero amplitude along an edge 29. Edge 29 is brief and may approach a sharp path.
- the opposite polarity waveform 28 may not return to zero amplitude and thus 28 may be contiguous with the beginning of the next cycle.
- the opposite polarity current amplitude is sufficiently small that the reverse polarity current minimizes the possibility of inducing action potentials on the wave trunk.
- the magnitude of the opposite polarity amplitude is selected such that the total current flow in the first and second portions 12 and 14 is equal but opposite. In this manner, there is no net charge transfer. It is to be appreciated that opposite polarity current pulses or portions of various shapes may be utilized provided the amplitude remains low and there are substantially no discontinuations along the path described by waveform portions 20 and 24.
- Waveform 10 is typically applied to a single nerve trunk using an arrangement which is shown in FIG. 2.
- an electrode cuff 30 is positioned about a nerve 32.
- a signai generator 33 is coupled to cuff 30 via a first electrode 34 located along the inner surface of cuff 30. and also to nerve 32 via a second electrode 36.
- electrode 34 acts as a cathode for signals transmitted from generator 33 to nerve 32, while electrode 36 acts as an anode for the circuit.
- nerves can be stimulated externally using pulses transmitted by generator 33 through anode 36 and cathode 34.
- FIG. 3 of the drawings the basic operating principle of the stimulator of the present invention can be explained.
- Stimulator 40 uses a single power supply 42 which drives a plurality of channels 44.
- six channels 44 a-f are shown.
- the output stage of each channel 44 is connected to each electrode cuff 30 (as shown in FIG. 2) which is used to stimulate a sacral root in the nerve trunk of a patient in the manner described in U.S. Patent No. 4,608,985, which patent is hereby incorporated by reference into this application.
- the electrode cuff 30 is connected between anode 36 and cathode 34 for each channel 44.
- Each channel 44 contains two independent current sources 50 and 52 connected to cathode 34. Current sources 50 and 52 are responsible for generating the two phases of quasitrapezoidal signal 10 which is shown in FIG. 1 , which is applied to the nerve.
- Each channel 44 contain a series of switching means 60, 62, 64.
- Switching means 60 which couples current source 50 to current source 52 and to cathode 34 via a capacitor 66
- switching means 62 which couples current source 52 to a ground loop 68
- generator 54 to activate current sources 50 and 52 at the proper times in order to generate the proper waveform 10, while switching means 64 is connected in parallel with an isolation resistor 70 between anode 36 and ground loop 68.
- FIG. 4 shows a representation of stimulator 40 according to the present invention in greater detail.
- current sources 50 and 52 along with switching means 60, 62 and 64 are all under complete control of a microcontroller 71 which handles the task of controlling the timing between all of the components of stimulator 40, and generates signal 10 by activating and inactivating current sources 50 and 52 and isolation resistors 70 in the proper timing sequence.
- current source 50 which is composed of a transistor 74 and a
- PMOSFET 76 in combination is initially activated by switch 60.
- switching means 60 is preferably a multiplexer which is capable of controlling all of the channels for stimulator 40.
- the amplitude of current source 50 is controlled by a potentiometer 78.
- Current source 52 which is composed of a transistor 80 and an OP- AMP 82 in combination, is controlled by switching means 62, which is preferably a multiplexer capable of controlling all of the channels in the present embodiment.
- the amplitude of current source 52 is also controlled by a potentiometer 84.
- potentiometers 78 and 84 are preferably digital devices which are set electronically by microcontroller 71.
- Switching means 64 which is also preferably a multiplexer in the present embodiment, acts to shunt isolation resistor 70 to ground when that specific channel 44 is active. In this way, the active channel 44 is shorted to ground loop 68, providing a path of zero resistance to the stimulus current, while the isolation resistors 70 in all of the other channels provide a high resistive path to the stimulus current, insuring that any leakage current will be minimized such that it will not affect the operation of stimulator 40.
- FIG. 5 shows the timing diagram associated with one firing sequence of stimulator 40.
- FIG. 5 there is shown the waveforms generated by a six-channel stimulator having output channels 44a-44f. In this design, the outputs are fired sequentially in reference to the first phase of the stimulus. Each channel 44 starts the first phase of its stimulus after the previous one has finished. This is true for both cathode 34 and anode 36 outputs and is designed to minimize the interference between channels.
- the cathode 34 outputs for all of the channels 44 are identical.
- the anode 36 outputs differ in the reversal phase of waveform 10 for each channel 44. This difference is due to the isolation resistor 70 and multiplexer switching circuit 64 in each channel 44.
- that particular isolation resistor 70 is shorted by multiplexer 64 to ground loop 68, providing a path of zero resistance to the stimulus current.
- the isolation resistors in the other channels are maintained intact, providing a high resistance path to the stimulus current.
- the current will flow mainly through the active channel while limiting the current in the other channels.
- the small amounts of currents that may escape isolation occur during phase 2 of waveform 10 of the active channel.
- cathode 34 outputs of the other channels receive less amounts of currents during that time, which is seen in reduced reversal phase of waveform 10 for those outputs (FIG. 5).
- the reversal phase of waveform 10 of anode 36 outputs of the other channel is restored after all channels have finished being activated.
- a circuit without isolation resistor 70 would allow current to flow from ail anode 36 outputs during the activation of a single channel 44, creating cross currents between the channels.
- FIGS. 6-8 An alternative design of nerve stimulator according to the present invention is shown in FIGS. 6-8.
- Stimulator 40' uses a single power supply 42', which drives a plurality of channels 44'. In the present embodiment, six channels 44' a-f are shown.
- the output stage of each channel 44' is connected to each electrode cuff 30 (as shown in FIG. 2) which is used to stimulate a sacral root in the nerve trunk of a patient in the manner described in US patent No. 4,608,985, which patent is hereby incorporated by the reference into this application.
- the electrode cuff 30 is connected between anode 36 and cathode 34 for each channel 44'.
- current source 52' there is one current source 52' common to all channels connected to cathode 34 a-f through a switching means 62'.
- Current source 52' is responsible for generating the first phase of the quasitrapezoidal signal 10, which is shown in FIG. 1 , which is applied to the nerve.
- the operation of current source 52' is controlled by the microcontroller 71.
- the second phase of signal 10 is created by the passive circuit 50'.
- Both current source 52' and passive circuit 50' are responsible fcr generating both phases of signal 10 which is biphasic and charge balanced in order to minimize electrode deterioration and tissue damage.
- Each channel 44' contains a series of switching means 62' and 64'.
- Switching means 62' couples the current source 52' to the ground loop 68', whiie switching means 64' is connected in parallel with an isolation resistor 70' between capacitor 66' and power supply 42'.
- Switching means 62' and 64' are turned on and off concurrently, which directs the flow of current to one particular channel.
- FIG. 7 shows a representation of stimulator 40' according to the present invention in greater detail.
- current source 52 ' along with switching means 62' and 64' are all under complete control of a microcontroller 71 ' which handles the task of controlling the time between all of the components of stimulator 40', and generates signal 10 by activating and inactivating current source 52' and isolation resistors70' in the proper timing sequence.
- current source 52' which is composed of transistor 80' and op- amp 82' in combination, has output that is distributed by switching means 62', which is preferably a multiplexer capable of controlling all of the channels in the present embodiment.
- switching means 62' which is preferably a multiplexer capable of controlling all of the channels in the present embodiment.
- the amplitude of current source 52' is controlled by a resistor array 84', which is under direct control of the microcontroller 71'.
- Switching means 64' which is also preferably a multiplexer in the present embodiment, acts to shunt isolation resistor 70' to power supply 42' when that specific channel 44' is active. In this way, the active channel 44' is shorted to power supply 42', providing a path of zero resistance to the stimulus current, while the isolation resistors 70' in all of the other channels provide a high resistive path to the stimulus current, insuring that any leakage current will be minimized such that it will not affect the operation of stimulator 40'.
- current flows in the opposite direction through capacitors 66' and potentiometer 78'. The amplitude of this reversal current is controlled by adjusting potentiometer 78'.
- This reversal current represents portion 14 of waveform 10 and its path is restricted in its own output channel since switching means 62' and 64' are no longer connected to that channel. Switching means 62' and 64' will not be connected to that channel until that point of time when that channel needs to be activated again.
- FIG. 8 shows the timing diagram associated with one firing sequence of stimulator 40'.
- FIG. 8 there is shown the waveforms generated by a six channel stimulator having output channels 44' a-44' f.
- the outputs are fired sequentially in reference to the first phase of the stimulus.
- Each channel 44' starts the first phase of its stimulus after the previous one has finished. This is true for both cathode 34 and anode 36 outputs and is designed to minimize the interference between channels.
- the design of the present invention was developed in a way that utilizes minimal hardware in order to maintain a small package size suitable for implantable use.
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- Health & Medical Sciences (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Electrotherapy Devices (AREA)
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU60452/99A AU6045299A (en) | 1998-09-17 | 1999-09-16 | Multiple channel nerve stimulator |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10087498P | 1998-09-17 | 1998-09-17 | |
US60/100,874 | 1998-09-17 | ||
US09/219,050 US6038477A (en) | 1998-12-23 | 1998-12-23 | Multiple channel nerve stimulator with channel isolation |
US09/219,050 | 1998-12-23 |
Publications (3)
Publication Number | Publication Date |
---|---|
WO2000016851A1 true WO2000016851A1 (en) | 2000-03-30 |
WO2000016851A8 WO2000016851A8 (en) | 2000-09-14 |
WO2000016851A9 WO2000016851A9 (en) | 2000-11-09 |
Family
ID=26797643
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/021386 WO2000016851A1 (en) | 1998-09-17 | 1999-09-16 | Multiple channel nerve stimulator |
Country Status (2)
Country | Link |
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AU (1) | AU6045299A (en) |
WO (1) | WO2000016851A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10631912B2 (en) | 2010-04-30 | 2020-04-28 | Medtronic Xomed, Inc. | Interface module for use with nerve monitoring and electrosurgery |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4608985A (en) | 1984-10-11 | 1986-09-02 | Case Western Reserve University | Antidromic pulse generating wave form for collision blocking |
US5178161A (en) * | 1988-09-02 | 1993-01-12 | The Board Of Trustees Of The Leland Stanford Junior University | Microelectronic interface |
-
1999
- 1999-09-16 WO PCT/US1999/021386 patent/WO2000016851A1/en active Application Filing
- 1999-09-16 AU AU60452/99A patent/AU6045299A/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4608985A (en) | 1984-10-11 | 1986-09-02 | Case Western Reserve University | Antidromic pulse generating wave form for collision blocking |
US5178161A (en) * | 1988-09-02 | 1993-01-12 | The Board Of Trustees Of The Leland Stanford Junior University | Microelectronic interface |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10631912B2 (en) | 2010-04-30 | 2020-04-28 | Medtronic Xomed, Inc. | Interface module for use with nerve monitoring and electrosurgery |
US10980593B2 (en) | 2010-04-30 | 2021-04-20 | Medtronic Xomed, Inc. | Interface module for use with nerve monitoring and electrosurgery |
US11950832B2 (en) | 2010-04-30 | 2024-04-09 | Medtronic Xomed, Inc. | Interface module for use with nerve monitoring and electrosurgery |
Also Published As
Publication number | Publication date |
---|---|
WO2000016851A9 (en) | 2000-11-09 |
WO2000016851A8 (en) | 2000-09-14 |
AU6045299A (en) | 2000-04-10 |
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