Self applied and self adjusting device and method for prevention of deep vein thrombosis with movement detection

• US 6,282,448 B1
• Filed: 05/18/1999
• Issued: 08/28/2001
• Est. Priority Date: 06/10/1998
• Status: Expired due to Term

• Current Assignee: DK Electronics, LLC
• Original Assignee: Amiram Katz, Orly Katz
• Inventors: Katz, Orly, Katz, Amiram
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/313,806
• Time in Patent Office: 833 Days
• Field of Search: 607/48, 607/63, 607/72, 607/76, 607/149
• US Class Current: 607/48
• CPC Class Codes: A61N 1/321 Electromedical belts
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: Y10S 128/15 Hook and loop type fastener

Abstract

An elongated rectangular cuff having electrodes combined with a motion detector for detecting muscle contraction with an attached control unit for providing a predetermined electrical signal to the electrodes. The predetermined electrical signal is substantially a square wave with a duration of between 0.1 and 0.3 milliseconds, a frequency of between 0.1 and 0.5 Hertz, with 5 to 15 repetitions delivered every 5 to 15 minute intervals. The control unit provides a controllable intensity of between 0.20 to 4 milliamperes, and a voltage between 1 and 200 volts at an output resistance of substantially 50 kilo Ohms. The cuff or sleeve, when wrapped around a user'"'"'s leg and positioned below the knee such that the electrodes contact the calf muscles, causes a muscle and nerve stimulation resulting in contraction of the calf muscle. A motion detector monitors the contraction and provides feedback to the control unit to adjust the signal. Blood flow is therefore increased regardless of body position or movement greatly decreasing the possibility of developing deep vein thrombosis or pulmonary embolism, which may be fatal. In addition it reduces ankle edema and leg discomfort associated with prolonged sitting. In addition it prevents orthostatic hypotension. An applied signal is continuously adjusted resulting in little risk of harm to the user.

Claims

1. A self applied device for use in preventing circulatory ailments comprising:

a cuff;

a fastening material placed on one end of said cuff;

a mating material placed on another end of said cuff, said mating fastening material adapted to attach to said fastening material;

a pair of electrodes positioned a predetermined distance apart and held by said cuff;

a control unit coupled to said pair of electrodes;

a motion detector positioned between said electrodes and coupled to said control unit; and

a power source attached to said control unit,

whereby a user can attach and position the device easily providing a safe and effective electrical signal causing muscle contraction detected by said motion detector.

2. A self applied device for use in preventing circulatory ailments as in claim 1 wherein:

the predetermined distance apart of said pair of electrodes is between seven and seventeen centimeters.

3. A self applied device for use in preventing circulatory ailments as in claim 2 wherein:

the predetermined distance apart of said pair of electrodes is approximately twelve centimeters.

4. A self applied device for use in preventing circulatory ailments as in claim 1 further comprising:

indicia placed on said rectangular cuff midway between said pair of electrodes,

whereby said indicia aids in the proper placement of said pair of electrodes on the leg of a user.

5. A self applied device for use in preventing circulatory ailments as in claim 1 wherein:

said control unit provides an electrical signal to said electrodes having a form of substantially a square wave with an intensity of between 0.02 to 4 milliamperes and between 1 and 200 volts, a duration of between 0.1 and 0.3 milliseconds, a frequency of between 0.1 and 0.5 Hertz, with 5 to 15 repetitions delivered every 5 to 15 minute intervals.

6. A self applied device for use in preventing circulatory ailments as in claim 1 wherein:

said pair of electrodes and said motion detector are disposable.

7. A self applied device for use in preventing circulatory ailments as in claim 1 wherein:

said motion detector comprises a strain gage.

8. A self applied device for use in preventing circulatory ailments as in claim 1 wherein:

said motion detector comprises an accelerometer.

9. A self applied device for use in preventing circulatory ailments as in claim 1 wherein:

said control unit eliminates the electrical signal from being provided to said pair of electrodes when muscle contractions have been detected by said motion detector sufficient to prevent circulatory ailments.

10. A self applied device for use in preventing circulatory ailments as in claim 1 further comprising:

means, associated with said control unit, for preventing said control unit from providing a signal to said pair of electrodes when a predetermined amount of muscle contraction is detected.

11. An electrical device for use in preventing circulatory ailments comprising:

a pair of electrodes;

signal means, attached to said pair of electrodes, for providing a signal to said pair of electrodes;

a motion detector placed adjacent said pair of electrodes, whereby contraction of a user'"'"'s muscle is detected;

a controller coupled to said motion detector and said signal means, said controller adjusting said signal means to provide a signal to said pair of electrodes causing a predetermined contraction in the user'"'"'s muscle;

means, associated with said controller, for determining activity of the user'"'"'s muscle sufficient to provide therapeutically adequate circulation, whereby said controller prevents said signal means from providing the signal to said pair of electrodes; and

a cuff having attached thereto said pair of electrodes, said motion detector, and said signal means,

whereby the electrical device is self adjusting providing effective treatment without adjustments by the user.

12. An electrical device for use in preventing circulatory ailments as in claim 11 wherein:

said signal comprises a form of substantially a square wave with an intensity of between 0.20 and 4 milliamperes, a voltage between 1 and 200 volts, a duration of between 0.1 and 0.3 milliseconds, a frequency of between 0.1 and 0.5 Hertz, with 5 to 15 repetitions delivered every 5 to 15 minute intervals.

13. An electrical device for use in preventing circulatory ailments as in claim 11 wherein:

said cuff is releasably attachable to the leg of a user.

14. An electrical device for use in preventing circulatory ailments as in claim 11 further comprising:

indicia placed on said cuff, said indicia located to assist in placement of said pair of electrodes on the leg of a user.

15. An electrical device for use in preventing circulatory ailments as in claim 14 wherein:

said indicia is a line placed midway between said pair of electrodes.

16. A self applied device for use in preventing circulatory ailments such as deep vein thrombosis or pulmonary emboli, venostasis, orthostatic hypotension, ankle edema and leg discomfort associated with prolonged sitting comprising:

an elongated rectangular cuff;

an insert removably attached to said elongated rectangular cuff;

a pair of electrodes placed on said insert;

a motion detector placed on said insert;

a control unit placed on said elongated rectangular cuff and coupled to said pair of electrodes and said motion detector, said control unit providing an electrical signal to said electrodes having a form of substantially a square pulse with an intensity of between 1 to 50 milliamperes, a voltage between 1 and 200 volts, a duration of between 0.1 and 0.3 milliseconds, a frequency of between 0.1 and 0.5 Hertz, with 5 to 15 repetitions delivered every 5 to 15 minute interval; and

a battery attached to said control unit,

whereby a user can attach and position the device easily for applying a safe and effective electrical signal causing muscle controlled contraction.

17. A self applied device for use in preventing circulatory ailments as in claim 16 wherein:

said elongated rectangular cuff has two lateral slits therein and said insert is partially inserted into the two lateral slits.

18. A self applied device for use in preventing circulatory ailments as in claim 16 further comprising:

adhesive placed on said pair of electrodes and said motion detector; and

a peel off strip placed over said adhesive, whereby said adhesive is protected prior to use.

19. A method for preventing circulatory ailments comprising the steps of:

providing a cuff with electrodes;

applying an electrical signal to a calf muscle of a leg of a user through said electrodes;

detecting contraction of the calf muscle of the user;

adjusting the electrical signal based upon the contraction of the calf muscle of the user to obtain a predetermined degree of contraction,

whereby a therapeutically appropriate degree of contraction is maintained without adjustment by the user.

20. A method for preventing circulatory ailments as in claim 19 wherein:

the electrical signal is in a form of substantially a wave with an intensity of between 0.20 to 4 milliamperes, voltage of between 1 and 200 volts, a duration of between 0.1 and 0.3 milliseconds, a frequency of between 0.1 and 0.5 Hertz, with 5 to 15 repetitions delivered every 5 to 15 minute intervals.

21. A method for preventing circulatory ailments as in claim 20 wherein:

the electrical signal comprises substantially a square wave.

22. A method for preventing circulatory ailments as in claim 20 wherein:

the electrical signal comprises an asymmetrical by-phasic pulse.

23. A method for preventing circulatory ailments as in claim 19 further comprising:

determining voluntary activity in the calf muscle of a user sufficient to provide a predetermined circulation; and

preventing application of the electrical signal to the calf muscle of a user,

whereby unnecessary signals are not applied to the user.

24. An insert for a cuff used in preventing circulatory ailments comprising:

a backing;

a pair of electrodes placed on said backing;

a motion detector placed on said backing, said motion detector positioned between said pair of electrodes,

whereby said backing may be inserted within the cuff and placed on a user'"'"'s leg.

25. An insert as in claim 24 wherein:

said motion detector is a strain gage.

26. An insert as in claim 24 wherein:

said motion detector is an accelerometer.

27. An insert as in claim 24 further comprising:

adhesive placed on said pair of electrodes and said strain gage; and

a peel off strip placed over said adhesive, whereby said adhesive is protected prior to use.

28. A self applied device for use in preventing circulatory ailments comprising:

a cuff;

a pair of electrodes positioned a predetermined distance apart and held by said cuff;

a control unit coupled to said pair of electrodes, said control unit providing an electrical signal to said electrodes having a form of substantially a square wave with an intensity of between 0.02 to 4 milliamperes, a duration of between 0.1 and 0.3 milliseconds, and a frequency of between 0.1 and 0.5 Hertz;

a motion detector positioned adjacent said electrodes and coupled to said control unit; and

a power source attached to said control unit,

whereby a user can attach and position the device easily providing a safe and effective electrical signal causing muscle contraction detected by said motion detector.

29. A self applied device for use in preventing circulatory ailments comprising:

a cuff;

a pair of electrodes positioned a predetermined distance apart and held by said cuff;

a control unit coupled to said pair of electrodes;

a motion detector positioned adjacent said electrodes and coupled to said control unit,

said control unit eliminating an electrical signal from being provided to said pair of electrodes when muscle contractions have been detected by said motion detector sufficient to prevent circulatory ailments; and

a power source attached to said control unit,

whereby a user can attach and position the device easily providing a safe and effective electrical signal causing muscle contraction detected by said motion detector.

30. A method for preventing circulatory ailments comprising the steps of:

applying an electrical signal to the muscle of a user;

detecting contraction of the muscle of the user; and

adjusting the electrical signal based upon the contraction of the muscle of the user so as to obtain a therapeutically effective increase in blood flow to the muscle of the user,

whereby a therapeutically appropriate degree of contraction is maintained without adjustment by the user.