WO1997010874A1 - Assembly for functional electrical stimulation during movement - Google Patents
Assembly for functional electrical stimulation during movement Download PDFInfo
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- WO1997010874A1 WO1997010874A1 PCT/CA1996/000618 CA9600618W WO9710874A1 WO 1997010874 A1 WO1997010874 A1 WO 1997010874A1 CA 9600618 W CA9600618 W CA 9600618W WO 9710874 A1 WO9710874 A1 WO 9710874A1
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- limb
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- stimulation
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Classifications
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- 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
- A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
Definitions
- This invention relates to an electronic stimulator comprising a garment carrying fixed electrodes and means for properly positioning the garment so that the electrodes overlie a nerve to be stimulated.
- the garment further carries means for monitoring body movement and means for activating the electrodes at appropriate intervals to stimulate the nerve and activate dormant muscles, thereby assisting the body in making a particular movement.
- the stimulator may be used to assist in overcoming "foot drop" affecting a person who has had a stroke.
- Functional electrical stimulation is a method for replacing function, such as walking or grasping, that is partially or completely lost after various lesions to the central nervous system, such as stroke or spinal cord injury.
- One of the most common deficits in the lower leg is "foot drop”. In this condition, the patient is unable to properly activate the muscles that flex the ankle, to enable the foot to clear the ground during the swing phase of walking. Instead, the foot drops and drags along the ground.
- AFO ankle-foot orthosis
- these electrical stimulators comprise a number of pieces, all of which have to be placed and connected together accurately. Carrying this out is a difficult and time-consuming chore for a patient who has likely lost some manual dexterity and who may have suffered some cognitive impairment as a result of stroke or injury. More specifically, these stimulator units typically comprise: (a) a box containing the stimulator, battery and control electronics, which have to be placed on the body or in a pocket; (b) electrodes which have to be placed accurately on the skin; (c) some garment, such as an elastic knee stocking, for supporting the electrodes in place; (d) a foot switch; and (e) wiring connecting the electronics and electrodes; 2. that the lengthy wiring is prone to breakage; 3.
- foot switch may not work reliably on all of several different surfaces such as pavement, carpet, sand, up and down ramps and the like; and 4. that some patients may not land on their heel or put little weight on it, due to spasticity or contractures in the calf muscles. These problems can lead to failure to trigger the stimulation.
- An alternative is to have a fixed duration of stimulation. This may be appropriate at some speeds of walking or levels of fatigue, but not at others.
- a stimulator in accordance with a preferred form of the present invention comprises, in combination: • a band of stretchable, breathable fabric having fastening means at its ends for securement of the band around the user's leg in the form of a ring; • anode and cathode electrodes carried by the band in a stationary or fixed condition; • locating means, carried by the band, for cooperating with the bony protuberance of the tibia, to accurately and reproducibly locate the electrodes over the nerve to be stimulated; • tilt sensor means, carried by the band, for measuring the angle of the lower segment of the leg relative to vertical in the sagittal (forward and back) plane and emitting sensor signals indicative thereof; • battery means, carried by the band, for supplying electrical current, as required; and • control means, carried by the band and connected with the sensor means, electrodes and battery means, for receiving the
- the band, carrying the components, is compact and thin enough to fit comfortably under pants or other clothing.
- the combination of the locating means and fastening means has enabled the assembly to be easily donned with the electrodes correctly located, even when handled by an impaired user. Test trials have shown that the entire assembly can be donned or doffed in less than a minute.
- the combination of the tilt sensor with the control means provides a fine degree of continuous leg position monitoring coupled with accurately initiated and terminated stimulation.
- the result is that stimulation can be closely related to leg position to provide an improved and refined pattern of stimulation, in comparison to prior art FES units.
- the device provides continuous sensory signals and turns the stimulus on and off regardless of the speed of walking.
- a resilient C-shaped carrier could replace the band.
- Another sensor such as an accelerometer or electric compass, could be substituted for the tilt sensor.
- the elastic band provides good securement and is easily donned and doffed.
- the tilt sensor provides accurate information even though the user is fat or thin, walks with shoes or in bare feet and walks fast or slow on a variety of surfaces having different inclinations.
- the tilt sensor further is less sensitive to pathological changes such as contractures or clonus at the ankle, than is the case for a heel switch.
- the invention is a functional electrical stimulator for use on a body limb, comprising: a band, mountable on the limb, for carrying stimulator components; cathode and anode electrodes carried by the band in a fixed condition; means, carried by the band, for reproducibly positioning the band so that the electrodes are located at specified stimulation locations; sensor means, carried by the band in a fixed condition, for measuring the angular position of the limb during movement and emitting sensor signals indicative thereof; control circuit means, carried by the band and connected with the sensor means and electrodes, for receiving the sensor signals, processing the sensor signals to establish values indicative of the changing angularity of the limb and to compare the established values with predetermined adjustable ON and OFF threshold values and initiating and terminating the emissions of pulses through the electrodes when the established values reach the ON and OFF threshold values, to stimulate the limb; and battery means, carried by the band and connected with the sensor means and control circuit means, for supplying electrical power.
- a patient using the apparatus in combination with a clinician or other means can generate the data necessary to better define the parameters such as angular ON and OFF threshold values and time thresholds.
- a hand switch, operated by a clinician, or a limb mounted sensor is used to define the states at which stimulation of the limb is required for proper limb movement.
- a template is defined for optimal stimulation of the limb.
- Figure 1 is a schematic showing the stimulator mounted on a leg with the locations of the tibia and common peroneal nerve shown in dotted lines;
- Figure 2 is a perspective view showing the stimulator with the pouch wall broken away to display the tilt sensor, battery and circuit boards;
- Figure 3 is a top view of the system, showing connections between the logic circuitry, tilt sensor, battery, stimulator circuits and the electrodes;
- Figure 4 is a block diagram showing the tilt sensor, logic, power and stimulator circuits and the electrodes;
- Figure 5 is a diagram showing the operation of the logic circuitry in conjunction with data recorded from a patient user;
- Figures 6 and 7 are diagrams showing the operation of the logic circuitry for data recorded from a patient according to original parameters ( Figure 6) and
- the stimulator 1 comprises a band 2 made of stretchable, breathable material.
- One suitable material is perforated neoprene, available from Rubatex Corporation, Bedford, VA.
- the band 2 forms a pouch 3, for containing stimulator components.
- Patches 4 of Velcro " fastening material are provided at the band ends to fasten them together, so that the band can form a snug ring around the user's leg 5 below the knee 6.
- a V-shaped metal plate 7 is positioned in the pouch 3 and fits snugly therein so as to be fixed along the length of the band. The plate 7 is weakened along its vertical mid-line.
- the plate may include vertical protrusions which lay parallel to and on opposing sides of the tibia to more positively constrain lateral movement relative to the tibia. Once so bent, the plate 7 can be located reproducibly on the tibia.
- Cathode and anode electrodes 9, 10 are attached to the band 2 with conductive snap connectors 11 as shown in Figure 3.
- the optimal placement of the electrodes 9, 10 is determined by a technician or clinician working with the patient.
- the cathode electrode 9 is usually placed where the common peroneal nerve 13 comes from behind the knee 6 past the head of the fibula 14. Placement of the anode electrode 10 is less critical. It is usually placed further along the course of the nerve 13, where it enters the ankle flexor muscles 12. Once these locations are determined, the band 2 is placed over the electrodes and holes are punched through the fabric with a hole punch.
- the electrodes contain a male connector that is fitted through the hole and connected with the female connector 11. These female connectors are attached to leads L1 , L2.
- the electrodes used are of the water-filled cotton type, available from the Josef Stefan Institute, Ljubljana, Slovenia.
- the band 2 is reproducibly positioned by fitting the plate 7 over the tibia 8, thereby locating the electrodes 9, 10 at the desired positions.
- a tilt sensor 17 (otherwise known as an inclinometer) is secured to a printed circuit board containing logic circuit 19 which in turn is attached to the positioning plate 7.
- the tilt sensor is fixed with respect to the tibia and the rest of the lower leg.
- the tilt sensor 17 functions to measure the angle of the lower leg with respect to the vertical in the sagittal plane and emit signals indicative thereof.
- One suitable sensor for this purpose is available from Midori Inc. Fullerton, CA, under the designation Model No. UV1.
- a 1.5 V AA alkaline or 1.2 V AA NiCd battery 18 for powering the components is attached to the plate 7.
- the output voltage of the battery 18 is increased to 3 volts by a DC-DC converter 28, for operation of the logic circuit 19.
- the battery output voltage is increased through a second converter (not shown) to 5 V and further then to 70 volts by a transformer 29, for operation of the stimulator circuit 20.
- the logic circuit 19 and stimulator circuit 20 are mounted to the plate 7 and together comprise control circuit means.
- the logic circuit 19 functions to receive the tilt sensor signals, condition them, compare them to threshold values related to changes in gait and to activate or de-activate the stimulator circuit 20 in response thereto.
- the logic circuit 19 is connected by suitable leads L3 - L6 with the battery 19, tilt sensor 17 and stimulator circuit 20.
- the tilt sensor 17 produces an analog sensor signal of varying voltage, dependent on its angular position relative to gravity This sensor signal is transmitted to the filter circuit 21 through lead L7.
- the filter R.C. circuit 21 removes the higher frequency acceleration signals.
- the filtered sensor signal is then amplified by operational amplifier 22
- the amplifier used is available from Texas Instruments under designation TLC 274.
- the amplifier 22 increases the output voltage by 10 to 20 times.
- the filtered, amplified (i.e. "conditioned") sensor signal is transmitted from filter R.C. circuit 23 to comparator circuit 24.
- the signal is an analog one, delivered in volts
- the comparator circuit 24 signals activation or deactivation of the stimulator circuit by emitting a digital control signal via lead L6
- the comparator circuit used is available from Texas Instruments under the designation TLC 274
- the comparator circuit 24 compares the conditioned sensor signal voltage with an angular ON threshold and operates to activate the stimulator circuit when the threshold is exceeded.
- a potentiometer 25 enables adjustment of the angular ON threshold.
- the potentiometer used is available from R S. Components Ltd., Corby, Northants., U.K., under the designation 186-974
- the comparator circuit 24 also compares the conditioned sensor signal voltage with an angular OFF threshold and operates to deactivate or turn off the stimulator circuit 20 if the voltage drops below this threshold.
- Potentiometer 30 (also available from R. S. Components) provides a variable amount of hysteresis.
- the angular OFF threshold will differ from the ON signal by an amount between 0 and 0.5 volts, depending on the setting of the potentiometer 30.
- the comparator circuit 24 emits a HI control signal (3 volts) when the conditioned sensor signal voltage becomes greater than the angular ON voltage (ON threshold) and a LOW control signal (0 volts) when the voltage becomes less than the angular OFF voltage (OFF threshold).
- the digital control signal is delivered via L6 to a timer circuit 26 (the function of which is described below) and thereafter to a lock-out circuit 27.
- lock-out period during which the lock-out circuit, via lead L5, prevents re-activation of the stimulus.
- the lock-out circuit used is available from Motorola Semiconductor Products Inc., Austin TX under designation CD4538. Lock- out normally occurs at about the time that the heel strikes the ground (see Figure 5), which gives rise to some oscillation (known as "clonus"). During clonus, even if the conditioned signal were to reach the angular ON threshold, the lock-out circuit 27 functions to continue to gate the comparator output LOW to prevent premature re- triggering of the stimulator circuit 20.
- the lock-out time can be adjusted between 0.1 and 1 second, using the potentiometer 32 (available from R. S Components).
- the comparator and lock-out circuits 24, 27 monitor the digital control signals and the comparator delivers a HI or a LOW digital signal, as
- the comparator circuit 24 delivers a HI signal to the stimulator circuit to turn stimulation ON.
- the comparator circuit delivers a LOW signal to turn the stimulation OFF.
- the OFF or LOW signal is processed through the lock-out circuit to introduce the appropriate delay.
- the patient's leg may not exhibit an angular OFF control signal which occurs early enough in time to properly deactivate the stimulator circuit 20. Therefore, in an alternate embodiment, the stimulator circuit may be deactivated by measuring the time which has elapsed, since the comparator 24 first signalled activation of the stimulation circuit, and comparing it against a maximum elapsed time threshold.
- the timer circuit 26 is configured to allow adjustment of the maximum allowable elapsed time from 0.2 seconds to 4 seconds using potentiometer 31 (available from R. S. Components).
- the timer circuit used is available from Motorola under designation CD4538. If the conditioned signal voltage does not go below the angular OFF threshold before reaching the maximum time threshold set by timer circuit 26, the comparator circuit 24 digital HI signal is gated LOW, signalling deactivation of the stimulator circuit 20, subject of course to the lock-out circuit 27.
- each of the parameters - angular ON and OFF thresholds, maximum time threshold and lock-out period - are adjustable through the potentiometers 25, 30, 31, and 32 respectively.
- a socket 33 is provided in the design so that the signals can be brought from the logic circuit to a digital computer for ease of adjusting the potentiometers and sensor data, as described later.
- Another socket 37 is also provided for connecting a hand or foot switch, should some patients be unable to use a tilt sensor due to the inability to generate sufficient tilt of the lower leg.
- the circuitry for processing these signals is not novel and is not detailed in Figure 4. Essentially, inserting a hand or foot switch into the jack disables the filter and amplifier circuits and the alternative devices are connected directly to the comparator circuit 24. A choice of sensors provides flexibility to the preferred design.
- the stimulator circuit 20 receives the digital control signal and delivers a series of stimuli (approximately 0.3 ms pulses at 40 ms intervals) through the electrodes 9, 10 for a period when the control signal remains HI. Also shown in Figure 2 are an amplitude control 34 for adjusting the strength of the stimulus (0 - 100 mA) and a switch 35 for tuming the stimulator and logic circuitry on and off.
- a suitable stimulator circuit, for this purpose, is available from Institute Josef Stefan under designation Mikrofes Stimulator. Reliable operation, even for persons whose movement is weak or who have considerable clonus (oscillation), is obtained as shown in Figure 5. This Figure illustrates two complete step cycles of a person using the device described in the embodiment above.
- the conditional tilt signal (after amplification and filtering) is illustrated by the solid line in the top part of the Figure. It increases as the body rotates over the leg, while the leg is on the ground during the stance phase of the step cycle. When the leg is behind the body, the angular ON threshold is exceeded (ON_TH. in Figure 5) and stimulation begins. Stimulation continues until 1) the tilt signal falls below the angular OFF threshold (OFF_TH. in Figure 5), as the leg is brought in front of the body during the swing phase of the step cycle, or 2) the
- the lockout circuit 27 prevents a subsequent re-triggering of the stimulation for a period of time, even if oscillations in the tilt signal reach the angular ON threshold (point A).
- the presence of hysteresis prevents the stimulus from turning off prematurely should the stimulus happen to fall below the angular ON threshold, but not below the OFF threshold (point B). Determination of stimulation requirements for proper limb movement is dependent, in part, upon the nature of the person's disability, the clarity of the signals received and differing physiological conditions such as walking speed and terrain.
- Set-points for stimulus initiation and termination can be represented by a template which define the state of stimulation as being either ON or OFF, as a function of angle and time.
- a template which define the state of stimulation as being either ON or OFF, as a function of angle and time.
- performance can be assessed and optimal adjustment for the control parameter settings can be predicted.
- One such template is defined by a trained clinician who, by observing the gait of a patient and using a hand on/off switch, signals when stimulus should optimally be in an ON or OFF state.
- a foot switch or one or more foot sensors can be temporarily employed during testing.
- a foot switch produces either and ON or an OFF signal and indicates when the foot lifts from the ground and subsequently strikes the ground.
- a foot sensor produces a continuous and variable analog signal proportional to a foot's force against the ground. As a result, the position of the foot is somewhat less certain.
- a signal threshold the signal can be analyzed to convert it to a binary ON/OFF or HI/LOW signal. More specifically, the threshold is set so that the signal is HI when the foot Ieaves the ground (force is lower than the threshold). The signal is set to LOW when the foot is lowered on to the ground and the signal falls below the threshold (force is greater than the threshold).
- stimulation occurs a short time after the foot's heel Ieaves the ground and is terminated a short time after the heel strikes the ground.
- a template patterned after a foot switch or sensor would incorporate appropriate time delays.
- the optimal state of stimulation defined either by a hand switch or foot switch, is stored by a digital computer for subsequent analysis.
- the ON or OFF state of the limb stimulation, as established by a hand switch or foot switch template is compared with that produced by the stimulator circuit for a stored set of tilt sensor test data, from a trial, comprising a plurality of step cycles. As shown in Table 1 below, four conditions are possible; an "error" representing that situation where the active circuit-generated state is inconsistent with the template-predicted state.
- the results are optimal when the percentage of recorded data in which the incorrect stimulation occurs during the trial (conditions 2 and 3) is minimized.
- the stimulus ON and OFF signal is responsive to a multiplicity of parameters, four of which are: ON and OFF thresholds based on tilt angle; maximal permitted time of stimulation (maximum time OFF threshold); and lockout time at heel strike. It is conceivable that variations in these four and other parameters can be made to improve or optimize the stimulator circuit performance as compared to the template.
- One approach to optimize multiple parameters is to apply a gradient- search technique. An error value is calculated as being the percentage of data samples having incorrect stimulation over the total number of samples for the set. The optimization approach is then applied to minimize the error value for a set of step
- a gradient-search basically varies the value of one parameter at a time and observes its effect on the error, seeking the greatest decrease (steepest descent) in error. When all parameters have been varied, without further decrease in error, the step size or magnitude of the variation is reduced and the process is repeated.
- the gradient-search optimization is performed as follows: • obtain and store a set of data samples for the patient comprising a plurality of uniform step cycles; • establish the initial magnitude of variation to be applied to each parameter, being typically 1/2 or 50 % of the difference between the current value of the parameter and its maximal range or value experienced in the set of data samples; • starting with the parameters that were last used (ie.
- the settings used during the patient's trials vary each parameter by the magnitude of its variation, apply it to the data and re-calculate the error (try both increasing and decreasing the value); • If the error is successfully decreased, then that new value for the parameter which produced the greatest reduction in the error is substituted; • repeat the process until the error cannot be reduced further; and • reduce the magnitude of the variation applied to each parameter by 1/2 and repeat the above. Typically, once the magnitude of the variation has been reduced to about 1 %, no further significant optimization of the error is apparent.
- the optimized parameters are then input at the logic circuit board for use by the patient. These values are then used by logic board 19 as the pre-determined adjustable threshold values. The values are input by manually adjusting physical potentiometers (as shown in Fig.
- the stimulation parameters are used for adjusting angular ON and OFF thresholds, time thresholds and lock-out time. These four parameters are sufficient for most cases, but other parameters could be added including the degree to which the signal is filtered. Optimization of the stimulation parameters is demonstrated in the following example. Walking data for one patient is shown in Figures 6 and 7. The patient was fitted with a tilt sensor and a foot switch. A 10 second period of tilt signal and foot switch samples was selected, representing eight of the patient's 8 step cycles. A template was established using the foot sensor data.
- Foot sensor data below a 0.38 volts threshold (range of 0.0 to 2.5 volts) was interpreted as the foot being on the ground (signal LOW) and data above 0.38 volts was interpreted as the foot being off of the ground (signal HI).
- a delay of 0.1 seconds was applied for defining the stimulation template from the HI/LOW data signal. More specifically, as shown in Figure 6 and 7, the template dictates that optimally, the leg stimulation should be initiated 0.1 seconds after foot off (at signal HI or > 0.38 V) and be terminated 0.1 seconds after the foot touches down (at signal LOW or ⁇ 0.38 V).
- the tilt sensor data of this particular patient did not exhibit a suitably timed angular OFF threshold (OFF_TH) and instead, leg stimulation was terminated after the maximum time OFF threshold, set (Tmax) by the timer circuit 26, was exceeded.
- Tmax the maximum time OFF threshold
- the actual stimulation was only applied in seven of the cycles; from about 2 seconds on. Practically, this means that the patient's foot was not stimulated for assisting in the flexing of the foot for clearing the ground during the forward swing phase of the leg. This occurred because the previous cycle of the leg did not cause the tilt sensor to reach the angular OFF threshold (point C) specified by the potentiometer setting for clearly indicating the termination of the patient's step cycle. It was only at about 2 seconds (point D) that the leg angle did finally drop below the OFF threshold and the end of a step cycle was clearly delineated.
- the original and optimized parameters are presented in Table 2 below:
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU69213/96A AU6921396A (en) | 1995-09-20 | 1996-09-18 | Assembly for functional electrical stimulation during movement |
CA002232672A CA2232672C (en) | 1995-09-20 | 1996-09-18 | Assembly for functional electrical stimulation during movement |
EP96929993A EP0855926A1 (en) | 1995-09-20 | 1996-09-18 | Assembly for functional electrical stimulation during movement |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/530,603 US5643332A (en) | 1995-09-20 | 1995-09-20 | Assembly for functional electrical stimulation during movement |
US08/530,603 | 1995-09-20 |
Publications (1)
Publication Number | Publication Date |
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WO1997010874A1 true WO1997010874A1 (en) | 1997-03-27 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/CA1996/000618 WO1997010874A1 (en) | 1995-09-20 | 1996-09-18 | Assembly for functional electrical stimulation during movement |
Country Status (5)
Country | Link |
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US (2) | US5643332A (en) |
EP (1) | EP0855926A1 (en) |
AU (1) | AU6921396A (en) |
CA (1) | CA2232672C (en) |
WO (1) | WO1997010874A1 (en) |
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Also Published As
Publication number | Publication date |
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EP0855926A1 (en) | 1998-08-05 |
US5814093A (en) | 1998-09-29 |
CA2232672C (en) | 2001-08-07 |
CA2232672A1 (en) | 1997-03-27 |
US5643332A (en) | 1997-07-01 |
AU6921396A (en) | 1997-04-09 |
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