Interferential and neuromuscular electrical stimulation system and apparatus

• US 20050278001A1
• Filed: 06/15/2005
• Published: 12/15/2005
• 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
• Granted Patent: US 7,613,518 B2
• Time in Patent Office: Days
• 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:

at least one electrode assembly adapted to deliver a stimulation treatment program to the tissue of a user; and

an electrical stimulation device operably coupled to the at least one electrode assembly, the electrical stimulation device including a user interface system having a first access level for a user and an operator interface system having a second access level for an operator,

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 function of the muscle 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 at least one stimulation treatment program, and wherein the second input set comprises at least one customizable characteristic of the at least one stimulation treatment program.

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

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

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

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

7. The multi-mode electrical therapeutic stimulation system of claim 6, wherein the at least one characteristic of the selected treatment mode includes a program, signal frequency, a first adjustable energy range, a time, a pulse width, and a stimulation intensity.

8. The multi-mode electrical therapeutic stimulation system of claim 6, further comprising internal relay circuitry operable to automatically switch the at least one electrode assembly between an IF configuration and an NMES configuration in the combination IF/NMES mode.

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

10. 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 at least one electrode to a target treatment area of a user; and

delivering the stimulation treatment program to the target treatment area.

11. The method of claim 10, 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.

12. The method of claim 11, 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.

13. The method of claim 12, further comprising the step of:

automatically switching the at least one electrode between an IF mode configuration and an NMES mode configuration when the delivered stimulation treatment program comprises a combination IF/NMES mode.

14. The method of claim 10, further comprising the steps of:

presenting a treatment effectiveness survey;

accepting a survey response; and

storing the survey response.

15. The method of claim 14, 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.

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

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

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

incorporating the report into a patient file.

18. The method of claim 17, wherein the steps of generating the report and incorporating the report into a patient file are performed automatically and electronically.

19. The method of claim 10, further comprising the step of:

providing a password prompt to access the operator interface.

20. 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 relay circuitry electrically coupled to the first and second electrode assemblies, the relay 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.

21. The multi-mode electrical therapeutic stimulation system of claim 20, wherein the operator interface includes the user interface.

22. The multi-mode electrical therapeutic stimulation system of claim 20, wherein the electrical stimulation device comprises a memory portion operable to store at least one preprogrammed electrical therapeutic stimulation treatment program.

23. The multi-mode electrical therapeutic stimulation system of claim 22, wherein the at least one preprogrammed electrical therapeutic stimulation treatment program is customizable via an operator interface.

24. The multi-mode electrical therapeutic stimulation system of claim 22, wherein the at least one preprogrammed electrical therapeutic stimulation treatment program comprises at least one characteristic customizable via the user interface.

25. The multi-mode electrical therapeutic stimulation system of claim 20, wherein the first stimulation treatment mode comprises an IF mode and the second stimulation treatment mode comprises an NMES mode.

26. 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.

27. The method of claim 26, 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.

28. The method of claim 26, 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.

29. The method of claim 28, 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.

30. The method of claim 29, further comprising step of:

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

31. The method of claim 28, further comprising to step of:

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

32. The method of claim 28, further comprising the step of providing a password prompt to access the operator interface.

33. The method of claim 28, 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.

34. The method of claim 33, 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.

35. The method of claim 34, further comprising the step of:

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

36. The method of claim 35, further comprising the step of:

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

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

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

38. The method of claim 37, wherein the step of generating a report is performed prior to incorporating the transmitted survey response and the usage data into the patient file,

39. The method of claim 37, wherein the steps of matching, generating, and incorporating are performed automatically and electronically.

40. A method for managing patient care associated with a patient-administered external medical device, the method comprising the steps of:

providing an external medical device to a patient for patient self-administration of a prescribed treatment regimen;

tracking the medical device by at least one characteristic associated with the patient and at least one characteristic associated with the medical device;

receiving an electronic data transmission from the medical device, the data transmission comprising quantitative medical device usage data related to patient administration of the external medical device, qualitative patient treatment data, or both;

matching the electronic data transmission to a patient file stored in a database by matching the characteristic associated with the patient and the characteristic associated with the medical device; and

incorporating at least a portion of the electronic data transmission into the patient file.

41. The method of claim 40, further comprising the steps of:

presenting an automated survey by the medical device;

receiving a patient response to the survey;

storing the patient response; and

transmitting the patient response as qualitative patient treatment data to the database.

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

generating a report comprising at least a portion of the electronic data transmission.

43. The method of claim 42, wherein the step of incorporating at least a portion of the electronic data transmission into the patient file further comprises incorporating the report into the patient file.

44. The method of claim 42, wherein the step of generating a report further comprises:

selecting at least a portion of the electronic data transmission according to an intended recipient of the report;

formatting the report based upon the selected data; and

automatically making the formatted report available to the intended recipient electronically.

45. The method of claim 44, wherein the step of automatically making the formatted report available comprises forwarding the report to the intended recipient by electronic mail.

46. The method of claim 44, wherein the step of automatically making the formatted report available comprises posting the report to an Internet-based patient file.

47. The method of claim 44, wherein the step of formatting the report further comprises customizing the report for the intended recipient.

48. The method of claim 42, wherein the step of generating a report further comprises generating a report comprising historical data.

49. The method of claim 40, wherein the external medical device is provided to the patient according to a prescription of a physician.

50. The method of claim 49, further comprising the step of:

establishing a schedule for receiving electronic data transmissions from the medical device; and

if a scheduled data transmission is not received, changing a status indicator of the patient file.

51. The method of claim 50, further comprising the step of:

automatically notifying the physician of the status indicator change.