Electrical neuromuscular stimulation device

• US 5,285,781 A
• Filed: 05/24/1991
• Issued: 02/15/1994
• Est. Priority Date: 05/26/1990
• Status: Expired due to Fees

• Current Assignee: MED-El Medicalelectronics Elektro-Medizinische Gerate GmbH
• Original Assignee: Stiwell S. A.
• Inventors: Brodard, Roland
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/705,078
• Time in Patent Office: 998 Days
• Field of Search: 128/421, 128/422, 128/423 R
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

Abstract

An electrical neuromuscular stimulation comprising at least one stimulation unit, which is portable and autonomous, controlled by a detachable and interchangeable information medium, previously programmed as a function of the treatment for each respective patient, equipped at its output with at least one pair of electrodes designed to be applied to the part of the patient'"'"'s body to be treated and to transmit trains of electrical stimulation impulses intended to cause contractions and muscular exercise or training, said stimulation unit comprising an electronic circuitry (hardware) of the amorphous type, under the supervision of a control software with interactive parameters and linked by coupling and interaction functions, with said software being memorized on the detachable information medium, with it being possible for the value of each parameter to evolve progressively throughout the program between previously programmed reference values, and any parameter being able to control another parameter.

Claims

1. An electrical neuromuscular stimulation device, comprising at least one autonomous portable stimulation unit equipped with at least one output with at least one pair of electrodes to be applied to the part of a patient'"'"'s body to be treated that are in electrical communication with electronic circuitry means that transmit trains of electrical stimulation impulses intended to cause contractions and muscular exercise or training through said electrodes, and software control means that controls and supervises the transmission of said trains of electrical stimulation impulses, including detachable and interchangeable information medium previously programmed as a function of the stimulation treatment parameters for individual patients and further including first means for enabling the value of each parameter of the stimulation treatment to evolve progressively between previously programmed reference values, and second means for enabling any parameter of stimulation treatment to control any other parameter of stimulation treatment.

2. A device according to claim 1 wherein the stimulation unit further comprises electrical impulse generating microprocessor means for enabling the value of any stimulation parameter to evolve in a continuous and progressive manner among previously assigned reference values, while any given parameter may control another parameter, as a function of the performance time of the program of treatment.

3. A device according to claim 2 wherein the microprocessor means calculates and supplies high frequency impulses to a first insulation cell comprising an output pulse shaper-amplifier of the stimulation current transmitted towards said electrodes, so as to form a rectifier stage, with the insulation cell being supplemented by an electronic polarity change-over switch stage that is controlled by the software control means through a second insulation cell.

4. A device according to claim 3 and further including means to progressively adapt the electrical impulses generated by the microprocessor means to cause consecutive series of muscular contractions, which enable the selection of an energetic aerobic, anaerobic alactic or anaerobic lactic metabolism.

5. A device according to claim 4 wherein the stimulation unit further comprises means subordinate to the software control means and to the microprocessor means for interrelating the different stimulation treatment parameters to make them interactive as a function of the automatic progress of the program of treatment, and in particular to make them interactive as a function of the automatic progress of the program of treatment, and in particular to make the intensity of the stimulation current subordinate to the frequency of the electrical impulses supplied, so as to ensure physiological muscular work and without any risk for the tendino-muscular appliance.

6. A device according to one of claims 2 to 5 wherein the stimulation unit is equipped with four outputs which are not electrically interconnected but which can be interrelated interactively by the connections specified by the software control means between the different stimulation treatment parameters as a function of the performance time of the program of treatment.

7. A device according to claim 6, and further comprising means for a data bus type connection for the external interactive control of the output channels of a plurality of stimulator units connected in network.

8. A device according to claim 7 wherein the stimulation unit further comprises a matrix dot LCD screen controlled by the software control means and second software means, providing the program of treatment, so as to enable the monitoring of all the functions of the device and of the stimulation, the stimulation unit further comprising function key means subordinate to the second software means enabling the program of treatment to be personalised, said screen and said function key means being disposed on a unit having means that fold down to form a protective cover.

9. A device according to claim 8, wherein said information medium further comprises program-cards preprogrammed with standard programs of treatment, each program being specific to a precise medical indication, and means to allow the user of the device to choose one of the programs of treatment, on a patient program-card which he introduces including a slot provided in said stimulation unit that is equipped with a connector for receiving said program-cards.

10. A device according to claim 9 wherein the stimulation unit further comprises means subordinate to the software control means and to the microprocessor means for memorising the intensity of the electrical stimulation current assigned by a therapist or by the patient and supplied to the electrodes as a function of the automatic progress of the program of treatment, and means to then progressively restore the same intensity at the time of a subsequent treatment, the stimulation unit further comprising means subordinate to the software control means and to the microprocessor means designed to monitor the observance of the treatment by the patient by measuring constantly the impedance of the charge between the two electrodes of each pair of electrodes throughout the entire treatment and by carrying out a preliminary test measurement by generating a constant current impulse of a subliminal intensity and of an adequate duration to allow the comparison of the voltage slope of this signal with a preprogrammed value, the stimulation unit further comprising safety means which can be operated by the patient to adjust exclusively the intensity of the stimulation within programmed units.

11. A device according to claim 3 wherein the stimulation unit further comprises means subordinate to the software control means and to the microprocessor means for interrelating the different stimulation treatment parameters to make them interactive as a function of the automatic progress of the program of treatment, and in particular to make the intensity of the stimulation current subordinate to the frequency of the electrical impulses supplied, so as to ensure physiological muscular work and without any risk for the tendino-muscular appliance.

12. A device according to claim 2 wherein the stimulation unit further comprises means subordinate to the software control means and to the microprocessor means for interrelating the different stimulation treatment parameters to make them interactive as a function of the automatic progress of the program of treatment, and in particular to make the intensity of the stimulation current subordinate to the frequency of the electrical impulses supplied, so as to ensure physiological muscular work and without any risk for the tendino-muscular appliance.

13. A device according to claims 1 to 11 wherein each output channel includes programming means for programming each output channel independently from the others and means to allow an interdependence of their activity, with every parameter of an output channel being able to control another output channel, so as to allow the programming of multiple muscular activities.

14. A device according to claim 2 wherein the stimulation unit further comprises means subordinate to the software control means and to the microprocessor means for memorising the intensity of the electrical stimulation current assigned by a therapist or by the patient and supplied to said electrodes as a function of the automatic progress of the program of treatment, and means to then progressively restore the same intensity at the time of a subsequent treatment.

15. A device according to one of claims 2 or 14 wherein the stimulation unit further comprises means subordinate to the software control means and to the microprocessor means to monitor the observance of the treatment by the patient by measuring constantly the impedance of the charge between the two electrodes of each pair of electrodes throughout the entire treatment and by carrying out a preliminary test measurement by generating a constant current impulse of a subliminal intensity and of an adequate duration to allow the comparison of the voltage slope of this signal with a preprogrammed value.

16. A device according to claim 1 wherein the stimulation unit further comprises safety means which can be operated by the patient to adjust exclusively the intensity of the stimulation within programmed limits.

17. A device according to claim 1 wherein the stimulation unit further comprises a matrix dot LCD screen controlled by the software control means an second software means, providing the program of treatment, so as to enable the monitoring of all the functions of the device and of the stimulation.

18. A device according to claim 17 wherein the stimulation unit further comprises function key means subordinate to the second software means enabling the program of treatment to be personalized.

19. A device according to claim 18, wherein the screen and the function key means are disposed on a unit having means that down to form a protective cover.

20. A device according to claim 1 wherein the stimulation unit further comprises a slot within said stimulation unit equipped with a connector for receiving said program-cards.

21. A device according to claim 20, wherein said information medium further comprises program-cards preprogrammed with standard programs of treatment, each program being specific to a precise medical indication, and means to allow the user of the device to choose one of the programs of treatment including introducing a program-card into the slot by replacing the previously established program-card.

22. A device according to claim 21 wherein the stimulation unit includes a connector in electrical communication with said electronic circuitry means and having a detachable cable fitted with an RS-232C type serial link, whereby said cable may be connected to a computer.

23. A device according to claim 21 wherein the stimulation unit further comprises a multi-function connector in electrical communication with said electronic circuitry means whereby the stimulator unit may be connected to a battery charger, an auxiliary power supply battery, and to peripheral control unit.

24. A device according to claim 23, and further comprising means providing for a data bus type connection for the external interactive control of the output channels of a plurality of stimulation units connected in network.

25. An electrical neuromuscular stimulation device, comprising at least one autonomous portable stimulation unit equipped with at least one output with at least one pair of electrodes to be applied to the part of a patient'"'"'s body to be treated that are in electrical contact with a microprocessor having electronic circuitry means that transmit trains of electrical stimulation impulses intended to cause contractions and muscular exercise or training through said electrodes, and software control means that controls and supervises the transmission of said trains of electrical stimulation impulses, including detachable and interchangeable information medium previously programmed as a function of the stimulation treatment parameters for individual patients and means for enabling the value of each parameter of the stimulation treatment to evolve progressively throughout the program between previously programmed reference values, and second means for enabling any parameter to control another parameter of stimulation treatment, the electronic circuitry means further comprising means for enabling the output of signals adapted for the treatment of both normally innervated muscles and peripherally enervated muscles, as well as ionotherapy.

26. A device according to claim 25 wherein the microprocessor calculates and supplies high frequency impulses to an insulation cell comprising an output pulse shaper-amplifier of the stimulation current transmitted towards said electrodes, so as to form a rectifier stage, with the insulation cell being supplemented by an electronic polarity change-over switch stage that is controlled by the software control means, through a second insulation cell.

27. A device according to claim 26 wherein the stimulation unit further comprises a matrix dot LCD screen and controlled by the software control means and second software means providing the program of treatment, so as to enable the monitoring of all the functions of the device and of the stimulation, the stimulation unit further comprising function key means subordinate to the second software means enabling the program of treatment to be personalised, said screen and said function key means being disposed on a unit having means that fold down to form a protective cover.

28. An electrical neuromuscular stimulation device, comprising at least one autonomous portable stimulation unit equipped with at least one output with at least one pair of electrodes to be applied to the part of a patient'"'"'s body to be treated that are in electrical contact with electronic circuitry means that transmit trains of electrical stimulation impulses intended to cause contractions and muscular exercise or training through said electrodes, and software control means that controls and supervises the transmission of said trains of electrical stimulation impulses, comprising means for ensuring an interaction of the parameters of the stimulation impulses and a linkage of said parameters by interrelation and interaction functions, with said software control means being memorised on detachable information medium, and means for enabling the value of each parameter of the stimulation impulses to evolve progressively throughout the program between previously programmed reference values, and means for enabling any parameter to control another parameter, the stimulation unit further comprising a matrix dot LCD screen controlled by the software control means and second software means providing the program of treatment, so as to enable the monitoring of all the functions of the device and of the stimulation, the stimulation unit further comprising function key means subordinate to the second software means enabling the program to be personalised, said screen and said function key means being disposed on a unit having means that fold down to form a protective cover.