Interferential and neuromuscular electrical stimulation system and apparatus

• US 7,613,518 B2
• Filed: 06/15/2005
• Issued: 11/03/2009
• Est. Priority Date: 06/15/2004
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Inventors: Moore, Gary L., Qin, Li
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US11/153,225
• Publication Number:
  US 20050278001A1
• Time in Patent Office: 1,602 Days
• Field of Search: 607/2, 607116-118, 607/48, 600/554, 600/557
• US Class Current: 607/48
• CPC Class Codes: A61N 1/323 Interference currents, i.e. treatment by several currents summed in the body
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A multi-mode electrical therapeutic stimulation system. The system includes circuitry for providing interferential stimulation, muscle stimulation, and pulsed DC stimulation with an automatic switchover of electrode configurations between types of interferential and muscle stimulation without the need to manually alter the positioning of the stimulation electrodes. In one embodiment, the system includes a simplified five-button user interface with pre-programmed user display screens and an operator interface through which a medical professional can alter settings, programs, and user configurations. In another embodiment, the system can also include a recharging/docking station having a built-in charging device and data port, providing for an automatic/periodic upload of compliance data from the device when the stimulator is placed in a modem cradle. A method for managing patient care associated with a patient-administered external medical device is also disclosed.

Claims

1. A multi-mode electrical therapeutic stimulation system comprising:

a plurality of electrodes adapted to deliver a stimulation treatment program to the tissue of a user; and

an electrical stimulation device operably coupled to the plurality of electrodes, the electrical stimulation device including—

internal circuitry electrically connected to the plurality of electrodes and operable to automatically switch between a first electrode electrical configuration and a second electrode electrical configuration as required to deliver the stimulation treatment program;

a user interface system having a first access level for a user;

an operator interface system having a second access level for an operator; and

wherein the operator interface system includes the user interface system, the user interface system is adapted to accept a first input set from the user, and the user interface system and the operator interface system are adapted to accept a second input set from an operator, the second input set controlling a function of the stimulation treatment program not accessible via the first input set.

2. The multi-mode electrical therapeutic stimulation system of claim 1, wherein the second access level includes a selection portion and a customization portion of the stimulation treatment program, and wherein the second input set comprises a customizable characteristic of the stimulation treatment program.

3. The multi-mode electrical therapeutic stimulation system of claim 2, wherein the first access level includes a stimulation treatment program selected in the second access level.

4. The multi-mode electrical therapeutic stimulation system of claim 3, wherein the stimulation treatment program selected includes a customizable characteristic selected and made available to the first access level in the second access level.

5. The multi-mode electrical therapeutic stimulation system of claim 4, wherein the characteristic includes a program, signal frequency, a first adjustable energy range, a time, a pulse width, and a stimulation intensity.

6. The multi-mode electrical therapeutic stimulation system of claim 2, wherein the second input set includes the first set of data and information.

7. The multi-mode electrical therapeutic stimulation system of claim 2, wherein the stimulation treatment program comprises an interferential (IF) mode, a neuromuscular electrical stimulation (NMES) mode, a combination IF/NMES mode, or a pulsed direct current (PDC) mode.

8. The multi-mode electrical therapeutic stimulation system of claim 2, wherein the selected treatment mode comprises a combination IF/NMES mode.

9. The multi-mode electrical therapeutic stimulation system of claim 8, wherein the first electrode electrical configuration is a cross-position IF configuration, and the second electrode electrical configuration is a parallel NMES configuration.

10. The multi-mode electrical therapeutic stimulation system of claim 1, further comprising a battery charging and communication device.

11. A method of providing therapeutic electrical stimulation by having a multi-mode electrical therapeutic stimulation system perform the steps of:

providing an operator interface of a multi-mode electrical therapeutic stimulation system;

accepting a first set of data via the operator interface;

providing a user interface of the stimulation system while restricting access to the operator interface;

accepting a second set of data via the user interface;

defining a stimulation treatment program based at least in part on the first set of data and the second set of data;

applying a plurality of electrodes to a target treatment area of a user;

automatically switching an electrical configuration of the plurality of electrodes; and

delivering the stimulation treatment program to the target treatment area.

12. The method of claim 11, wherein the step of accepting the first set of data comprises accepting at least one available stimulation treatment program, the step of accepting the second set of data comprises accepting a stimulation treatment program selection, the selection made from the at least one available stimulation treatment program.

13. The method of claim 12, wherein the at least one available stimulation treatment program comprises an interferential (IF) mode, a neuromuscular electrical stimulation (NMES) mode, a combination IF/NMES mode, or a pulsed direct current (PDC) mode.

14. The method of claim 13, wherein automatically switching an electrical configuration of the plurality of electrodes comprises automatically switching between an IF mode configuration and an NMES mode configuration when the delivered stimulation treatment program comprises a combination IF/NMES mode.

15. The method of claim 11, further comprising the steps of:

presenting a treatment effectiveness survey;

accepting a survey response; and

storing the survey response.

16. The method of claim 15, further comprising the step of:

periodically transmitting stimulation system usage data to a central database, wherein the system usage data comprises the survey response and qualitative usage data.

17. The method of claim 16, further comprising the step of:

generating a report based at least in part upon the uploaded system usage data.

18. The method of claim 17, further comprising the step of:

incorporating the report into a patient file.

19. The method of claim 18, wherein the steps of generating the report and incorporating the report into a patient file are performed automatically and electronically.

20. The method of claim 11, further comprising the step of:

providing a password prompt to access the operator interface.

21. A multi-mode electrical therapeutic stimulation system comprising:

an electrical therapeutic stimulation device comprising a first output channel and a second output channel;

a first electrode assembly electrically connected to the first output channel; and

a second electrode assembly electrically connected to the second output channel;

wherein the electrical stimulation device comprises automatically reconfigurable internal switching circuitry electrically coupled to the first and second electrode assemblies, the switching circuitry having a first configuration for a first stimulation treatment mode and a second configuration for a second stimulation treatment mode,

and wherein first and second stimulation treatment modes each comprise one of an interferential (IF) mode, a neuromuscular electrical stimulation (NMES) mode, a combination IF/NMES mode, or a pulsed direct current (PDC) mode.

22. The multi-mode electrical therapeutic stimulation system of claim 21, wherein the operator interface includes the user interface.

23. The multi-mode electrical therapeutic stimulation system of claim 21, wherein the electrical stimulation device comprises a memory portion operable to store at least one preprogrammed electrical therapeutic stimulation treatment program.

24. The multi-mode electrical therapeutic stimulation system of claim 23, wherein the at least one preprogrammed electrical therapeutic stimulation treatment program is customizable via an operator interface.

25. The multi-mode electrical therapeutic stimulation system of claim 23, wherein the at least one preprogrammed electrical therapeutic stimulation treatment program comprises at least one characteristic customizable via the user interface.

26. The multi-mode electrical therapeutic stimulation system of claim 21, wherein the first stimulation treatment mode comprises an IF mode and the second stimulation treatment mode comprises an NMES mode.

27. The multi-mode electrical therapeutic stimulation system of claim 21, wherein the reconfigurable internal switching circuitry comprises relay circuitry.

28. The multi-mode electrical therapeutic stimulation system of claim 21, wherein the reconfigurable internal switching circuitry comprises a high-voltage analog switch.

29. A method of delivering a multi-mode electrical therapeutic stimulation treatment program comprising the steps of:

providing a multi-mode electrical therapeutic stimulation system having first and second output channels and first and second electrode assemblies, the first and second electrode assemblies respectively associated with the first and second output channels;

storing in the stimulation system at least one electrical therapeutic stimulation treatment program comprising a first stimulation treatment mode portion and a second stimulation treatment mode portion;

delivering the first stimulation treatment mode portion of the selected muscle stimulation treatment program to a target treatment area of a user via the first and second electrode assemblies;

automatically switching the first and second output channels internal to the stimulation system; and

delivering the second stimulation treatment mode portion of the selected electrical therapeutic stimulation treatment program to a target treatment area of a user via the first and second electrode assemblies.

30. The method of claim 29, wherein the first stimulation treatment mode portion comprises an interferential (IF) mode and the second stimulation treatment mode portion comprises a neuromuscular electrical stimulation (NMES) mode.

31. The method of claim 29, further comprising the steps of:

providing at least one selectable treatment program via an operator interface; and

accepting at least one program selection via the operator interface.

32. The method of claim 31, further comprising the steps of:

providing the at least one program selection as an option via a user interface; and

accepting a treatment program selection via the user interface.

33. The method of claim 32, further comprising step of:

presenting at least one customizable characteristic of the treatment program selection via the user interface.

34. The method of claim 31, further comprising to step of:

presenting at least one customizable characteristic of the treatment program selection via the operator interface.

35. The method of claim 31, further comprising the step of providing a password prompt to access the operator interface.

36. The method of claim 31, further comprising the steps of:

storing multi-mode electrical therapeutic stimulation system usage data;

establishing a communication connection with a central database;

transmitting the stored multi-mode electrical therapeutic stimulation system usage data to the central database; and

reporting transmission status information.

37. The method of claim 36, further comprising the steps of:

providing an automated survey;

accepting and storing a survey response; and

transmitting the stored survey response with the multi-mode electrical therapeutic stimulation system usage data to the central database.

38. The method of claim 37, further comprising the step of:

matching the transmitted survey response and the usage data with a patient file.

39. The method of claim 38, further comprising the step of:

incorporating the transmitted survey response and the usage data into the patient file.

40. The method of claim 39, further comprising the step of:

generating a report based at least in part upon the transmitted survey response and the usage data.

41. The method of claim 40, wherein the step of generating a report is performed prior to incorporating the transmitted survey response and the usage data into the patient file.

42. The method of claim 40, wherein the steps of matching, generating, and incorporating are performed automatically and electronically.

43. A multi-mode electrical therapeutic stimulation device comprising:

a case housing a stimulator, the case including an output channel interface operable to electrically couple a cable, electrode or other treatment applicator to the stimulator;

an interface including an input portion and an output portion, wherein the output portion comprises a display screen for displaying options of a first and a second electrostimulation treatment mode, or a combination of the first and second electrostimulation treatment modes, to a user or operator, and the input portion is operable to receive input from a user or operator for selecting the first or the second electrostimulation treatment mode displayed via the output portion;

a stimulator adapted to deliver a first and a second electro stimulation signal corresponding, respectively, to the first and second electro stimulation treatment modes, the stimulator comprising a first output channel having first and second electrical nodes, and a second output channel having first and a second electrical nodes, and channel switching circuitry, wherein the channel switching circuitry is adapted to enable delivery of the first electrostimulation signal though the first and second electrical nodes of the first output channel, and the second electrostimulation signal though the first electrical node of the first output channel and the first electrical node of the second output channel.

44. The multi-mode electrical therapeutic stimulation device of claim 43, wherein the first electrostimulation treatment mode is a IF treatment mode and the second electrostimulation treatment mode is an NMES treatment mode.

45. The multi-mode electrical therapeutic stimulation device of claim 43, wherein the switching circuitry comprises internal relays.

46. A stimulation device providing electrical stimulation therapy, comprising:

a set of electrodes comprising a first pair of electrodes and a second pair of electrodes, the set adapted for placement on a treatment area of a patient to form a placement position;

a first output circuit for delivering a first electrical stimulation treatment to the set of electrodes and comprising a first output portion and a second output portion;

a second output circuit for delivering a second electrical stimulation treatment to the set of electrodes and comprising a first output portion and a second output portion;

a first channel output electrically connected to the first pair of electrodes;

a second channel output electrically connected to the second pair of electrodes; and

a switching circuit operably connected to the first and second output circuits and the first and second channel outputs and having a first selectable switching position and a second selectable switching position, wherein;

the first switching position completes an electrical connection between the first output portion of the first output circuit and the first pair of electrodes and between the second output portion of the first output circuit and the second pair of electrodes, thereby forming a first electrical electrode configuration and delivering a first stimulation treatment to the treatment area, and

the second switching position completes an electrical connection of the first output portion of the second output circuit and one electrode of the first pair of electrodes and one electrode of the second pair of electrodes and an electrical connection of the second output portion of the second output circuit and one electrode of the first pair of electrodes and one electrode of the second pair of electrodes, thereby forming a second electrical electrode configuration and delivering a second stimulation treatment to the treatment area;

such that electrical stimulation therapy may be automatically switched between a first stimulation treatment utilizing a first electrical electrode configuration and a second stimulation treatment utilizing a second electrical electrode configuration without changing the placement position of the set of electrodes.

47. The stimulation device of claim 46, wherein the first stimulation treatment is an interferential stimulation treatment and the second stimulation treatment is an NMES treatment.

48. The stimulation device of claim 46, wherein the first electrical configuration comprises a cross-electrode configuration and the second electrical configuration comprises a parallel-electrode configuration.

49. The stimulation device of claim 46, wherein a selection of the first selectable switching position or the second selectable switching position is determined by an external input to the stimulation device.

50. The stimulation device of claim 46, wherein the switching circuit comprises internal relays.