Independent protection system for an electrical muscle stimulation apparatus and method of using same

• US 20060217768A1
• Filed: 01/30/2006
• Published: 09/28/2006
• Est. Priority Date: 01/28/2005
• Status: Active Grant

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Inventors: Guex, Steve, Dunant, Etienne, Buhlmann, Felix, Muller, Pierre-Yves, Truffer, David
• Granted Patent: US 8,140,165 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• 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

Abstract

Electrotherapy systems and methods for delivering an electrostimulation treatment program to a user while reducing the risk of inducing cardiac fibrillation. The systems and methods detect electrostimulation treatment program delivery characteristics, including a pulse intensity above a preset limit; a pulse duration above a preset limit; an inappropriately compensated pulse; a charge per pulse above a predetermined limit; a current improperly exiting from a stimulation channel; a current present outside of a pulse; an excitation pulse and a compensation pulse generated on different channels; an inter-pulse time less than a predetermined limit; and a time between an excitation and a compensation pulse greater than a predetermined limit. The limits are selected in relation to an objective of reducing the risk of inducing cardiac fibrillation.

Claims

1. An electrotherapy system for delivering an electrostimulation treatment program to a user with a reduced risk of inducing cardiac fibrillation, the electrotherapy system comprising:

an electrical pulse generator operable to generate electrical pulses according to an electrostimulation treatment program;

at least one electrode assembly electrically coupled to the pulse generator by at least one stimulation channel;

a command module coupled to the at least one stimulation channel and communicatively coupled to the pulse generator to operably control delivery of the electrostimulation treatment program to a user via the electrode assembly; and

an independent protection system communicatively coupled to the at least one stimulation channel and the command module and operable to monitor the electrostimulation treatment program to detect at least one characteristic of the electrostimulation treatment program, wherein the independent protection system is operable to maintain or alter an operating state of the electrotherapy system based upon the at least one characteristic detected to reduce the risk of inducing fibrillation when the electrotherapy system is applied to muscle groups proximate the cardiac region.

2. The electrotherapy system of claim 1, wherein electrotherapy system comprises two stimulation channels, each stimulation channel comprising one electrode assembly of two electrodes, wherein each stimulation channel and electrode assembly is arranged in an H-bridge configuration.

3. The electrotherapy system of claim 2, wherein the at least one characteristic comprises a current present in more than one half of an H-bridge at a time, within a pulse.

4. The electrotherapy system of claim 1, wherein the at least one characteristic is selected from the group consisting of a pulse intensity above a preset limit;

a pulse duration above a preset limit;

an inappropriately compensated pulse;

a charge per pulse above a predetermined limit;

a current improperly exiting from a stimulation channel;

a current present outside of a pulse;

an excitation pulse and a compensation pulse generated on different channels;

an inter-pulse time less than a predetermined limit; and

a time between an excitation and a compensation pulse greater than a predetermined limit.

5. The electrotherapy system of claim 4, wherein the at least one characteristic is selected from the group consisting of a pulse intensity greater than about 152 milliamps;

a pulse duration greater than about 1.5 milliseconds;

a charge per pulse greater than about 10 micro-Coulombs;

an inter-pulse time less than about 700 microseconds; and

a time between excitation and compensation pulses greater than about one millisecond.

6. The electrotherapy system of claim 4, wherein an inappropriately compensated pulse is determined according to the relationship:

7. A method of using an electrotherapy system including a safety system to reduce the risk of inducing cardiac fibrillation, the method comprising the steps of:

applying at least one electrode of an electrotherapy system to a user;

selecting an electrostimulation treatment program of the electrotherapy system;

generating electrostimulation pulses according to the selected program;

delivering the pulses to the user via the at least one electrode;

detecting at least one characteristic of the generated and delivered pulses by the safety system; and

maintaining or altering an operating state of the electrotherapy system based upon the at least one characteristic detected to reduce the risk of inducing fibrillation when the electrotherapy system is applied to muscle groups proximate the cardiac region.

8. The method of claim 7, wherein the step of detecting at least one characteristic further comprises detecting at least one characteristic selected from the group consisting of:

a pulse intensity above a preset limit;

a pulse duration above a preset limit;

an inappropriately compensated pulse;

a charge per pulse above a predetermined limit;

a current improperly exiting from a stimulation channel electrically coupled to the at least one electrode;

a current present in more than one half-bridge of the electrotherapy system at a time, within a pulse;

a current present outside of a pulse;

an excitation pulse and a compensation pulse generated on different channels of the electrotherapy system;

an inter-pulse time less than a predetermined limit; and

a time between an excitation pulse and a compensation pulse greater than a predetermined limit.

9. The method of claim 8, wherein the step of detecting at least one characteristic further comprises detecting at least one characteristic selected from the group consisting of:

a pulse intensity greater than about 152 milliamps;

a pulse duration greater than about 1.5 milliseconds;

a charge per pulse greater than about 10 micro-Coulombs;

an inter-pulse time less than about 700 microseconds; and

a time between excitation and compensation pulses greater than about one millisecond.

10. The method of claim 8, wherein the step of detecting at least one characteristic further comprises detecting an inappropriately compensated pulse according to the relationship:

11. The method of claim 8, wherein the step of maintaining or altering an operating state of the electrotherapy system further comprises automatically powering off the electrotherapy system if the at least one characteristic is detected.

12. The method of claim 7, further comprising the steps of:

programming at least one electrostimulation treatment program; and

storing the at least one electrostimulation treatment program in the electrotherapy system.

13. An electrotherapy system including a safety system to reduce the risk of inducing cardiac fibrillation, the system comprising:

input means for selecting an electrostimulation treatment program of the electrotherapy system;

voltage generator means for generating electrostimulation pulses according to the selected program;

electrode means for delivering electrostimulation pulses according to the selected program to a user;

a safety system comprising microprocessor means for detecting at least one characteristic of the generated and delivered pulses and for maintaining or altering an operating state of the electrotherapy system based upon the at least one characteristic detected to reduce the risk of inducing fibrillation when the electrotherapy system is applied to muscle groups proximate the cardiac region of the user.

14. The electrotherapy system of claim 13, wherein the microprocessor means for detecting at least one characteristic further comprises means for detecting at least one characteristic selected from the group consisting of a pulse intensity above a preset limit;

a pulse duration above a preset limit;

an inappropriately compensated pulse;

a charge per pulse above a predetermined limit;

a current improperly exiting from a stimulation channel electrically coupled to the at least one electrode;

a current present in more than one half-bridge of the electrotherapy system at a time, within a pulse;

a current present outside of a pulse;

an excitation pulse and a compensation pulse generated on different channels of the electrotherapy system;

an inter-pulse time less than a predetermined limit; and

a time between an excitation pulse and a compensation pulse greater than a predetermined limit.

15. The electrotherapy system of claim 14, wherein the microprocessor means for detecting at least one characteristic further comprises means for detecting at least one characteristic selected from the group consisting of a pulse intensity greater than about 152 milliamps;

a pulse duration greater than about 1.5 milliseconds;

a charge per pulse greater than about 10 micro-Coulombs;

an inter-pulse time less than about 700 microseconds; and

a time between excitation and compensation pulses greater than about one millisecond.

16. The electrotherapy system of claim 14, wherein the microprocessor means for detecting at least one characteristic further comprises means for detecting an inappropriately compensated pulse according to the relationship:

17. The electrotherapy system of claim 14, wherein the microprocessor means further comprises means for automatically powering off the electrotherapy system if the at least one characteristic is detected.

18. The electrotherapy system of claim 13, further comprising:

programming means for entering at least one electrostimulation treatment program; and

memory means for storing the at least one electrostimulation treatment program in the electrotherapy system.