Microprocessor-controlled multiplexed functional electrical stimulator for surface stimulation in paralyzed patients

• US 5,014,705 A
• Filed: 04/07/1989
• Issued: 05/14/1991
• Est. Priority Date: 04/07/1989
• Status: Expired due to Fees

• Current Assignee: Sigmedics Incorporated of Delaware
• Original Assignee: Sigmedics Incorporated of Delaware
• Inventors: Graupe, Daniel, Arber, Amihadar
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US07/335,197
• Time in Patent Office: 767 Days
• Field of Search: 128/419 R, 128/421, 128/422, 128/420.5, 128/420.6, 128/903, 128/423 W
• US Class Current: 607/49
• CPC Class Codes: A61F 4/00 Methods or devices enabling patients or disabled persons to operate an apparatus or a device not forming part of the body operating or control means for prostheses A61F2/48, A61F2/68
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance

Abstract

In accordance with the present invention, a functional electrical stimulation system enables upper-motor-neuron paraplegic patients and certain other paralyzed or partially paralyzed patients to stand and to take steps with the support of a walker in an independent fashion so that they are in control of the stimulation and, noting that they have very little or not sensation, that they still can obtain some feedback on the state of the system. In one embodiment, a compact and safe battery-operated stimulation system is provided that is of pocket size and that allows for non-invasive safe and controlled stimulation using skin surface electrodes.

The system of the present invention is a stimulation system for providing upper-motor-neuron paralyzed patients with capabilities of unbraced standing and unbraced walking, which consists of a single pulse power and amplifier that outputs various trains of stimulation pulses and which is totally under microprocessor generation and control, where the microprocessor'"'"'s microcomputer selectively performs multiplexing of the pulse trains and their selective alternate distribution to the various surface electrodes attached to the skin of the patient at the appropriate stimulation locations. It also controls pulse-width, pulse-duration, pulse-amplitude and pulse-shape.

Furthermore, the system can compute and activate (audible and/or visual) warning signals to warn the patient when the system is close to its maximal output. This would happen when muscle fatigue is such that no further increase in stimuli level can keep the patient upright. The system computes and outputs indications of the various stimuli levels to a visual display, and it provides automatic fail-safe and override capabilities to help ensure that the patient does not fall in case of major circuit or system failure or misactivation. This is a critical capability since this sytem will be used by paraplegics who lack sensation in their lower extremities.

Claims

1. An electrical stimulation system, for coupling to a plurality of electrodes coupled to locations at the right and left side of a lower part of the body of a patient, said system comprising:

pulse generator means for selectively outputting trains of pulses having selectively variable duration and pulse repetition frequency responsive to a control signal;

memory for storing operational instructions and data;

control means for selectively outputting said control signal responsive to said memory and to input commands;

pulse amplifier means for selectively amplifying pulse amplitude and power responsive to said control means;

multiplexer means for selectively multiplexing outputs of said pulse amplifier means from said pulse generator means and alternatively between selected ones of said electrodes responsive to said control means;

a battery power supply;

wherein said electrodes are wired in pairs as channels, wherein there are at least 4 channels, one adapted contact to the right quadriceps muscle, one to the left quadriceps muscle, one to the right common peroneal nerve and one to the left common peroneal nerve.

2. The system as in claim 1 wherein there are two additional channels, one adapted to contact to the right gluteus maximus muscle and one adapted to contact to the left gluteus maximus muscle.

3. The system as in claim 2, wherein said control means has means for providing an off-state and on-state, wherein at each initial switching from said off-state to said on-state, the pulses output to the quadriceps muscles and gluteus maximus muscles are gradually increased in amplitude having a slope of ramplike form, for an initial predefined time interval commencing with said initial switching.

4. The systems as in claim 3, wherein said initial time interval is in the range of approximately one to two seconds.

5. The system as in claim 3, wherein at the end of said initial time interval, the envelope of the amplitude of the output pulses slightly overshoots and then reaches a steady state level, wherein overshoot takes place for a short time duration of the order of a few second or less.

6. The system as in claim 5, wherein the duration of said initial interval, the initial amplitude of said pulse outputs, the overshoot level, and the steady-state level are determined responsive to said control means.

7. The system as in claim 2 further comprising;

input command means for providing mode input command signals, wherein said control means selectively provides one of a plurality of modes responsive to said input command signals.

8. The system as in claim 7, wherein said control means switches modes of operation responsive to said input command means to provide a stand mode, a take left step mode, a take right step mode, and a sit down mode.

9. The system as in claim 8, wherein during said stand mode the pulse outputs are selectively multiplexed to the right and left quadriceps channels and to the right and left gluteus maximus channels.

10. The system as in claim 8, further comprising channels adapted to be coupled to the area of right and left common peroneal nerves.

11. The system as in claim 10, wherein during the take left step mode the pulse outputs are selectively output to the right quadriceps channel and left common peroneal channel, while at the same time no stimulus is output to the left quadriceps muscle and to the right common peroneal nerve.

12. The system as in claim 10, wherein during the take right step mode the pulse outputs are selectively output to the left quadriceps channel and the right peroneal channel, while at the same time no stimulus output to the right quadriceps muscle and to the left peroneal nerve.

13. The system as in claim 10, wherein between each of said take right step mode and said take left step mode said system automatically returns to said stand-up mode, where none of the common peroneal nerves receive stimuli.

14. The system as in claim 10, wherein there are four output channels, wherein two of said channels provide for stimulating the vicinity of the quadriceps muscles, and wherein a two position switch is incorporated into the system to switch the other two of said four output channels so that in one switch position the output of said other two channels is coupled for output to the vicinity of the common peroneal nerve and in the other switch position the output of said other two channels is coupled for output to the region of the gluteus maximus.

15. The system as in claim 8, wherein the system is only permitted to switch to said sit-down mode from said stand mode.

16. The system as in claim 8, wherein said sit-down mode the amplitude of the pulse outputs to the quadriceps channels and gluteus maximus channels are gradually reduced to zero, over a predetermined time period on the order of seconds.

17. The system as in claim 8, wherein said control means automatically switches said system to said stand-up mode in the absence of command inputs to provide a fail-safe feature for the system.

18. The system as in claim 17, wherein said fail-safe feature is operative in case of circuit failure.

19. The system as in claim 17, wherein said fail-safe feature is operative in case of communication-link failure.

20. The system as in claim 8, wherein if a step is activated and remains activated for a time duration that exceeds a predetermined duration then the control means automatically returns the system to said stand-up mode after a predetermined time.

21. The system as in claim 20, wherein following an activation of a step for a time duration beyond said predetermined duration, then the system returns to said stand mode and remains in that mode until sit-down mode is activated, wherein no further step can be taken.

22. The system as in claim 21, wherein following an activation of a step for a time duration that exceeds said predetermined duration, a warning signal that is distinguishable from other warning signals of the system is activated by said control means.

23. The system as in claim 20, wherein following an activation of a step for a time duration beyond said predetermined duration, the system returns to said stand-up mode, whereafter further steps can be activated to enable the patient to take further steps.

24. The system as in claim 20, wherein following an activation of a step for a time duration that exceeds said predetermined duration, a warning signal that is distinguishable from other warning signals of the system is activated responsive to said control means.

25. The system as in claim 8, wherein said input command means is further comprised of a manual switch command circuit mounted on a patient support device, wherein said "sit-down" function can also be activated from the manual switch command circuit, and wherein this activation of the "sit-down" function from said manual switch command circuit is responsive to a predetermined long time duration pressing of an appropriate command switch, of an order of seconds, wherein the execution of the "sit-down" function by the control means is delayed from the time of the switching of said appropriate switch by another predetermined time delay of several seconds in the range of 5 to 12 seconds, so as to allow the patient to position himself properly to sit-down, and wherein during said predetermined time delay, the patient can override the activation of the above "sit-down" function by pressing of any other switch wherein the system is returned to the "stand mode" of claim 14.

26. The system as in claim 25, wherein the "sit-down" activation on the manual switch command circuit is performed responsive to the pressing of either of said "take left-step" and "take right-step" switch to command the exection of a take step command, responsive to pressing either of said take step switches for a time duration that is longer than a predefined time of approximately one to five seconds, wherein the execution of either of said take step commands is responsive to a shorter duration pressing of said switch to distinguish between said commands to take a step and said command to sit-down, wherein said system prevents inadvertantly activating said "sit-down" function.

27. The system as in claim 26, wherein the system activates a visual signal to inform the patient that said "sit-down" command has been activated.

28. The system as in claim 25, wherein the system activates a visual signal to inform the patient that said "sit-down" command has been activated.

29. The system as in claim 28, wherein said warning signal is a flashing light signal.

30. The system as in claim 25, wherein said override is executed responsive to pressing any switch.

31. The system as in claim 25, wherein the "sit-down" activation on the manual switch command circuit is performed responsive to the pressing of both "take right step" and "take left step" simultaneously for a time duration that is longer than a predetermined time duration.

32. The system as in claim 2, wherein the amplitudes of the pulse outputs is adapted to be coupled for output to the quadriceps and gluteus maximus muscles, are gradually increased over an initial time period after switching the system "on" for initial stand up, to a first level that exceeds a subsequent steady state level of these pulses, and wherein that amplitude is dropped to said steady state level at the end of said initial time period.

33. The system as in claim 32, wherein said drop in amplitude of said pulse outputs to their respective steady state level at the end of said initial period is gradual.

34. The system as in claim 32, wherein said initial time period is in the range of approximately one to two seconds.

35. The system as in claim 32, wherein said first level exceeds said steady state level in the range of zero to one hundred percent of said steady state level.

36. The system as in claim 1, wherein said electrodes are wired in pairs as channels, wherein there are two additional channels, one to the right gluteus maximus muscle and one to the left gluteus maximus muscle.

37. The system as in claim 1 further comprising;

input command means for providing mode input command signals, wherein said control means selectively provides one of a plurality of modes responsive to said input command, signals.

38. The system as in claim 37, wherein said input command means are switches.

39. The system as in claim 37, wherein said input command means is comprised of a manual command switch circuit.

40. The system as in claim 39, wherein said manual switch command circuit is mounted on a patient support device.

41. The system as in claim 40, wherein said patient support device is a walker.

42. The system as in claim 40, wherein the manual switch command switch circuit is mounted on the patient support device permits only level adjustment.

43. The system as in claim 42, wherein said level adjustment is for adjusting pulse amplitude.

44. The system as in claim 43, wherein the degree of change in the pulse output is determined responsive to the duration of the pressing of said switch.

45. The system as in claim 44, further characterized in that the longer the duration of pressing, the larger is the incremental change of level.

46. The system as in claim 40, wherein said patient support device is a reciprocal walker.

47. The system as in claim 42, wherein with each pressing of a switch of said level adjustment switches the control means selectively provides for a change in output pulse stimuli level by a predefined increment.

48. The system as in claim 47, wherein said increment is linear.

49. The system as in claim 47, wherein said increment is scaled.

50. The system as in claim 47, wherein said increment is exponential.

51. The system as in claim 47, further comprising means for displaying a visual display signal of the pulse output stimulus level for the channel having its level manually modified responsive to switch activation at the time of modification and for a short time thereafter wherein said visual display signal is a numerical display.

52. The system as in claim 47, further comprising means for displaying a visual display signal of the pulse output stimulus level for the channel having its level manually modified responsive to switch activation at the time of modification and for a short time thereafter wherein if no level adjustment is made at a given time, then the level displayed is that of a quadriceps channel having the highest stimulus level.

54. The system as in claim 39, wherein said manual command circuit is mounted on a panel of a casing having electronics of the system and on a patient support device.

55. The system as in claim 54, wherein said patient support device is a walker.

56. The system as in claim 54, wherein said patient support device is a reciprocal walker.

57. The system as in claim 54, wherein the manual command switch circuit is mounted on the patient support device permits only level adjustment.

58. The system as in claim 57, wherein said patient support device is physically separate from the remainder of the system which is encased in a housing, wherein said interconnection means is further comprised of a wireless telemetry device having a transmitter mounted on the patient support device and having a receiver mounted on said housing.

59. The system as in claim 58, wherein said telemetry device is a radio frequency telemetry device.

60. The system as in claim 58, wherein said telemetry device is an ultra-sound acoustic telemetry device.

61. The system as in claim 58, wherein said telemetry device is an infrared telemetry device.

62. The system as in claim 54, wherein said level adjustment is of pulse width.

63. The system as in claim 39, wherein said manual command switch circuit communicates with said control means to provide input commands to determine the mode of the system.

64. The system as in claim 63, further comprising interconnection means for coupling said input commands from said manual switch command circuit to said control means.

65. The system as in claim 64, wherein said patient support device is physically separate from the remainder of the system which is encased in a housing, wherein said interconnection means is further comprised of a set of cables having two ends each with appropriate fast connect polarized plugs and sockets for connection to said housing on one end and to the manual switch control circuit, which is mounted on the said patient support device, on the other end.

66. The system as in claim 63, wherein said input means is further comprised of switches to provide command inputs for increase and decrease of stimulation levels of said pulse outputs to each of said channels.

67. The system as in claim 66, wherein said switches are mounted to a housing encasing said stimulation system.

68. The system as in claim 63, wherein said manual command switch circuit further communicates additional input commands to said control means to determine the level of pulse output to multiple channels.

69. The system as in claim 68, wherein said multiple channels are further characterized as the right and left quadriceps channels, the right and left gluteus maximus channels, and the right and left peroneal channels.

70. The system as in claim 39, wherein said manual command switch circuit is further comprised of mode switches for right-step, left-step and sit-down.

71. The system as in claim 39, wherein said manual command switch circuit is further comprised of level adjustment switches for communicating input commands to said control means to selectively increase and decrease the level of stimulus to said right quadriceps channel, said left quadriceps channel, said right peroneal channel and said left peroneal channel.

72. The system as in claim 39, wherein said manual switch command circuit is mounted on.

73. The system as in claim 4, wherein the plurality of electrodes comprise skin surface electrodes for coupling to said locations on the patient,

further characterized in that said locations include the region of the common peroneal nerve and the region of the gluteus maximus muscles.

74. The system as in claim 73, further characterized in that said locations further include the vicinity of the gluteus maximus muscle.

75. The system as in claim 73, wherein said pulse outputs are selectively and alternaively multiplexed between said electrodes in a sequence and order and having selectively variable amplitude responsive to said control means to provide for multiple modes of stimulation.

76. The system as in claim 4, wherein said pulse output stimuli are in the form of trains of pulses in pairs, wherein a pulse of one polarity is followed in close succession by a pulse of the opposite polarity, and wherein the time distance between the pulse of the first polarity and the successive pulse of opposite polarity in a pair is very much shorter than the time interval between the one pair of pulses and the next such pair of pulses.

77. The system as in claim 76, wherein said second pulse of a pair of closely successive pulses is of lower amplitude than the lead pulse in the respective pair.

78. The system as in claim 4, wherein the pulse amplifier'"'"'s output is connected to a non-linear voltage-sensitive load such that this output is selectively loaded by a resistance of appropriate value when any channel output to the stimulation electrodes exceeds a predetermined value.

95. The system as in claim 40, wherein said patient support device is crutches.

53. An electrical stimulation system, for coupling to a plurality of electrodes coupled to locations at the right and left side of the lower part of the body of a patient, said system comprising:

pulse generator means for selectively outputting trains of pulses having selectively variable duration and pulse repetition frequency responsive to a control signal;

memory means for storing operational instructions and data;

control means for selectively outputting said control signal responsive to said memory and to input commands;

pulse amplifier means for selectively amplifying pulse amplitude and power responsive to said control means;

multiplexer means for selectively multiplexing outputs of said pulse amplifier means from said pulse generator and alternatively between selected ones of said electrodes responsive to said control means; and

a battery power supply and a portable casing within which said system is mounted,

wherein said pulse generator means and said control means are further characterized as comprising a single microcomputer, and an Analog to Digital Converter (ADC), wherein said microcomputer selectively outputs through said ADC a single pulse train to said pulse amplifier means, wherein said pulse amplifier means is comprised of a single pulse amplifier, wherein the output of the pulse amplifier means is multiplexed to distribute its output to at least 4 channels, wherein the multiplexer means is further comprised of solid state switch devices, wherein said control means switches modes of operation responsive to said input command means to provide a "stand" mode, a "take left step" mode, a "take right step" mode, and a "sit down" mode, wherein the levels of said pulse trains are ramped at an initial "stand" mode stand-up from an initial "sit-down" mode sit position, wherein at a subsequent "sit-down" mode the levels of said pulse trains decreases to zero in a ramp manner to avoid sudden cessation of power, wherein said microcomputer receives said input commands from both an external switching array mounted on a patient support device that is coupled by a coupling to said casing enclosing said microcomputer, pulse amplifier, ADC and multiplexer, and, from a switching array mounted on said casing, wherein switching input commands are coupled from said external array including two sets of switches, one mounted on the right side of patient'"'"'s support device and one mounted on the left side of same, wherein said right side switches include one step switch to select command of "take right step" and one level switch to select command of both increasing pulse level for right quadriceps and for increasing pulse level for producing a right step, wherein increasing of pulse level for right quadriceps is commanded by a single short pressing of said level switch, wherein each such pressing produces a fixed increment increase in pulse level, and wherein a long duration pressing of said level switch beyond a predetermined duration selects a command to increase level of pulse to the common peroneal nerve to produce a step, wherein said left side switches do the same respectively for the left quadriceps and left step, wherein switching to command sit down is performed by long duration pressing for a duration longer than some predetermined duration, of a selected switch, and wherein once said sit down has been commanded, said control means delays execution of sit down command for a different predetermined time duration.

79. The system as in claim 53, wherein said pulse trains have levels which are ramped at initial stand-up and are further characterized in that the initial ramp overshoots slightly above a subsequent steady state pulse level.

80. The system as in claim 53, wherein said patient support device is a reciprocal walker.

81. The system as in claim 53, wherein said external switching array is coupled to said casing by cabling.

82. The system as in claim 53, wherein said external switching array is coupled to said casing by telemetry.

83. The system as in claim 53, wherein said two sets of switches are all automatic release switches that automatically return to their non-switched position upon releasing the switch pressure.

84. The system as in claim 53 wherein said pulse level adjustments are in terms of adjusting pulse amplitude.

85. The system as in claim 53 wherein said pulse level adjustments are in terms of adjusting pulse width.

86. The system as in claim 53 wherein said selected switch for sit-down is further characterized as having a separate sit-down switch.

87. The system as in claim 53, wherein said switches on said casing are further comprised of separate switches for increasing level of pulses to right and left quadriceps muscles and level of pulses to common peroneal nerve to execute each step, wherein there is also a seperate switch for sit down and one for stand, wherein there are also separate switches to command decrease of each of the above pulse levels and where there is also a system on-off switch, wherein said casing also includes the battery power supply pack and a pulse level display that displays the level of the pulses to the channel whose level is manipulated at the time for a short predetermined time duration afterwards, and wherein the casing also includes a visual display of "low battery" and a warning display of maximal level of pulses to that quadriceps channel whose level is the highest, wherein the level at which said warning is activated is selectively determined responsive to the microprocessor, wherein there is a first audible alarm for low battery and another audible alarm, distinguishable from said first audible alarm, for maximal level of pulses that parallels the respective said visual alarm displays, the audible alarms being placed within said casing, wherein there are output sockets from the casing for output of said stimuli to the skin surface electrodes attached to the patient at the appropriate locations, wherein said microcomputer provides means for providing safety features, comprising means for returning the system to stand mode after sit down mode override, means for returning to stand mode after each step mode, and of returning to stand mode responsive to said step mode being activated in excess of a predefined time, and which disallows right and left step from being activated simultaneously, wherein said safety means delays execution of sit down mode for a predetermined time duration and allows override of said sit down mode by pressing any switch during said time duration, said safety means providing means for returning the system to said stand mode whenever otherwise no take step or sit down command is received and allowed by said microcomputer, including when no command inputs at all are received by said microcomputer,

wherein all interpretation of switch pressure duration and all other interpretations and setting of the various predetermined time durations are determined by the microcomputer, wherein all safety features are provided responsive to said same microcomputer and all outputs to and determination of warnings except for low battery warning, are set responsive to said microcomputer, wherein all overrides are set by said microcomputer, and wherein said microcomputer sets pulse microcomputer, and wherein said microcomputer sets pulse repetition frequency, pulse width and pulse amplitude, and degree of overshoot responsive to input commands.

88. The system as in claim 87, wherein there is also a mode switch to change between stimulation of common peroneal nerve and of gluteus maximus such that at the gluteus maximus mode no steps may be taken but otherwise all commands to level change of pulses to common peroneal nerve to execute a step become commands to level change of pulses to gluteus maximus.

89. The system as in claim 87, wherein said pulse level display is comprised of a numeric display.

90. The system as in claim 87, wherein said pulse level display is comprised of LED.

91. The system as in claim 87, wherein said visual warning is placed on said patient'"'"'s support device.

92. The system as in claim 53, wherein said selected switch for sit down is any of said "take step" switches.

93. The system as in claim 53, wherein said selected switch for sit down is comprised of the simultaneous activation of left and right "take step" switches.

94. The system as in claim 53, wherein said system returns to stand mode responsive to the pressing of any switch during said predetermined time duration after sit down has been commanded.