External counterpulsation unit

• US 6,620,116 B2
• Filed: 12/08/2000
• Issued: 09/16/2003
• Est. Priority Date: 12/08/2000
• Status: Active Grant

• Current Assignee: Michael P. Lewis
• Original Assignee: Michael P. Lewis
• Inventors: Lewis, Michael P.
• Primary Examiner(s): DeMille, Danton D.
• Application Number:
  US09/733,276
• Publication Number:
  US 20020173735A1
• Time in Patent Office: 1,012 Days
• Field of Search: 601/152, 601/41, 601/44, 601/151, 602/13, 128/DIG.20
• US Class Current: 601/41
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2230/04 Heartbeat characteristics, e.g. E.G.C., blood pressure modulation
• CPC Class Codes: A61H 31/006 Power driven
• CPC Class Codes: A61H 9/0078 with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: Y10S 601/20 Flexible membrane caused to be moved

Abstract

This invention is an improved medical device for non-invasive counterpulsation treatment of heart disease and circulatory disorder through external cardiac assistance. The device is comprised of cuffs which are affixed on a patient'"'"'s lower body and extremities, and which constrict by electromechanical activation, thereby augmenting blood pressure for treatment purposes. Cuffs contain preferably fixed volume fluids such as gel, air, or water. Cuffs wrap around and are affixed to the patient'"'"'s lower body and limbs. Computer or electronic means automatically correlate constriction of electromechanical actuators in the cuffs variably with the patient'"'"'s measured physiological indicators, including diastolic and systolic heart functions, thereby augmenting blood pressure and optimizing benefit of counterpulsation treatment.

Claims

1. A method of treating a medical condition using counterpulsation with electromechanically activated cuffs comprising the steps of:

a. detecting physiological data from a patient through use of medical devices;

b. transmitting said physiological data electronically from said devices to a processor;

c. electronically processing said physiological data to determine when the patient'"'"'s heart is in a diastolic or a systolic phase;

d. electronically activating a plurality of electromechanical cuffs;

each said electromechanical cuff having at least one constriction set, said constriction set having an actuator unit and a tension attachment, each said actuator unit being controllably operable to a plurality of positions, said plurality of positions being within a range of positions, said range of positions ranging from a relaxed position to a constricted position, a distance between said actuator unit and said tension attachment, said distance with said actuator unit in said relaxed position being greater than said distance with said actuator unit in said constricted position, and said distance directly related to each position of said actuator unit in said range of positions, and said actuator unit controllably operable from said relaxed position to any of said positions within said range of positions on activation;

e. electronically timing said activation of each said electromechanical cuff to correlate with the phases of the patient'"'"'s heart; and

f. modifying said timing of said activation of said plurality of electromechanical cuffs according to changes in said physiological data affected by said activation.

2. The method of claim 1 further comprising activating a series of said electromechanical cuffs, which are affixed to a patient'"'"'s body and extremities, from a distal to a proximal direction on the patient.

3. The method of claim 1 further comprising activating a series of said electromechanical cuffs, which are affixed to a patient'"'"'s body and extremities, from a proximal to a distal direction on the patient.

4. The method of claim 1 further comprising sequentially activating a series of said electromechanical actuator units, which are situated on cuffs affixed to a patient'"'"'s body.

5. The method of claim 1 further comprising sequentially activating a series of electromechanical actuator units, said electromechanical actuator units being situated on cuffs affixed to a patient'"'"'s body, and wherein a typical delay between initiation of activation of any two sequential said actuator units is in the range of 12 to 36 milliseconds.

6. The method of claim 1 further comprising activating each cuff in a series of cuffs, said cuffs being compressed from a distal to proximal direction on the patient, so that there are between 35 and 50 milliseconds between initiation of activation of each cuff in the series.

7. The method of claim 1 further comprising activating each of the electromechanical cuffs on the patient separately to compress with a strength in the range 0.1 an 7.0 pounds of pressure per square inch.

8. The method of claim 1 further comprising activating each of the electromechanical cuffs such that a graded pressure is applied to the patient.

9. The method of claim 1 further comprising activating each of the electromechanical cuffs so that a graded sequential pressure is applied to a patient.

10. The method of claim 1 further comprising activating each of the electromechanical cuffs independently so that one actuator unit or cuff in a series compresses more quickly than will a separate unit or cuff.

11. The method of claim 1 further comprising relaxing a series of said electromechanical cuffs, which are affixed to a patient'"'"'s body and extremities, from a distal to a proximal direction on the patient.

12. The method of claim 1 further comprising relaxing the series of said electromechanical cuffs, which are affixed to a patient'"'"'s body and extremities, from a proximal to a distal direction on the patient.

13. The method of claim 1 further comprising relaxing the series of said electromechanical cuffs, which are affixed to a patient'"'"'s body and extremities simultaneously.

14. The method of claim 1 further comprising setting activation of each cuff in a series of said cuffs, which are compressed from a proximal to distal direction on the patient, so that there is a range of 35 and 50 milliseconds between activation of each cuff in the series.

15. A unit for use in counterpulsation treatment of patients comprising:

a. a means for obtaining and transmitting physiological data from a patient.

b. a means for electronically receiving said physiological data;

c. a means for processing said physiological data and to correlate and activate a plurality of actuator cuffs according to said physiological data;

d. said plurality of actuator cuffs to be received on a patient, each said actuator cuff having at least one constriction set, said constriction set having an actuator unit and a tension attachment, each said actuator unit being controllably operable to a plurality of positions, said plurality of positions being within a range of positions, said range of positions ranging from a relaxed position to a constricted position, a distance between said actuator unit and said tension attachment, said distance with said actuator unit in said relaxed position being greater than said distance with said actuator unit in said constricted position, and said distance directly related to each position of said actuator unit in said range of positions;

e. said actuator unit controllably operable from said relaxed position to any of said positions within said range of positions on activation; and

,

f. a means for modifying said activation of said plurality of actuator cuffs according to changes in said physiological data affected by said activation.

16. The counterpulsation device as described in claim 15 wherein said actuator cuffs are rectangular or trapezoidal in shape to accommodate increasing or decreasing thickness of patient extremities.

17. The counterpulsation device as described in claim 15 wherein each of said plurality of actuator cuffs further comprises:

a. a flexible surface layer having a top and a bottom;

b. a flexible bladder section contiguous with the bottom side of the surface layer;

c. a flexible liner layer contiguous with the bottom layer of the flexible bladder section;

d. a plurality of tension strap attachments fixed at an end of the top side of the flexible surface layer;

e. a plurality of actuator units on an opposite end of the top side of the flexible surface layer;

f. an actuator attachment located within each of said actuator units; and

,

g. a plurality of cuff connectors which each attach at one end to the tension strap attachments, each of said cuff connectors having an opposite end being attached to said actuator attachments.

18. The counterpulsation device as in claim 17, wherein the flexible liner layer is chosen from the group consisting essentially of teflon, plastic, nylon, or aramid.

19. The counterpulsation device as in claim 17, wherein the flexible surface layer is chosen from the group consisting essentially of kevlar, plastic, nylon, or aramid.

20. The counterpulsation device as in claim 17, wherein said cuff connectors are of synthetic material having both a layer of tiny hooks and a complementary layer of a clinging pile;

said two layers of material are capable of being pulled apart or pressed together for easy fastening and unfastening, and for attachment of both ends of the actuator cuff.

21. The counterpulsation device as in claim 17, wherein each said actuator unit and each said tension strap attachment has a tension spread footing.

22. A counterpulsation device as in claim 17, wherein said flexible surface layer is decreased in thickness at a stepped point along an entire width of one end forming an overlap section which continues until the surface layer becomes a tapered point;

and

wherein the entire width of an opposite end of said flexible surface layer defines an abrupt taper upward from a point beyond contact with the flexible bladder section.

23. The counterpulsation device as in claim 17, wherein a sum thickness of the flexible surface layer, flexible bladder section, and flexible liner layer is between 0.1 and 3.0 inches at the thickest point.

24. The counterpulsation device as in claim 17, wherein a cuff width is in the range of 1.0 and 20.0 inches.

25. The counterpulsation device as in claim 17, wherein length of the cuff is in the range of 4.0 and 40.0 inches.

26. The counterpulsation device as in claim 17, wherein a diameter of an affixed actuator cuff as measured from said flexible liner layer is in the range of 1.0 and 12.0 inches.

27. The counterpulsation device as in claim 17 wherein the flexible bladder section further comprises a plurality of bladder subsections with a plurality empty cavities between each said subsection.

28. The counterpulsation device as described in claim 15 wherein each of said actuator cuffs further comprises:

a. a separate upper section and separate lower section adapted for connection with one another;

b. said upper and lower sections each having a flexible bladder section contiguous with a flexible surface layer on a first side of said flexible bladder section and contiguous with a flexible liner layer on a second side of said flexible bladder section;

c. a plurality of actuator units fixed at the ends of said upper section on a surface of the flexible surface layer opposite said flexible bladder;

d. an actuator attachment situated within each of said actuator units;

e. a plurality of tension strap attachments fixed at opposite ends of the lower section and on a surface of the flexible surface layer opposite the flexible bladder layer; and

,

f. a plurality of cuff connectors which attach at one strap end to the tension strap attachments, and which have an opposite end adapted for receipt by said actuator attachments.

29. The counterpulsation device as described in claim 28 wherein said actuator units and wherein said tension strap attachments have tension spread footings.

30. The counterpulsation device as in claim 28, wherein said flexible surface layer of the lower section decreases in thickness at a stepped point, along the entire width of both ends of said lower section to form an overlap section;

the overlap section is followed by a tapered end where the thickness of the flexible surface layer decreases to a point.

31. The counterpulsation device as in claim 28, wherein the flexible surface layer of the upper section is tapered at opposite ends to a narrow thickness along the entire width of said ends defining an abrupt taper;

said abrupt taper beginning at each end at a point beyond contact with the flexible bladder section.

32. A counterpulsation device as in claim 28, wherein the flexible liner layer is chosen from the group consisting essentially of teflon, plastic, nylon, or aramid.

33. The counterpulsation device as in claim 28, wherein the flexible surface layer is chosen from the group consisting essentially of kevlar, plastic, nylon, or aramid.

34. The counterpulsation device as in claim 28, wherein said cuff connectors are synthetic material having both a layer of tiny hooks and a complementary layer of a clinging pile;

said two layers of material can be pulled apart or pressed together for easy fastening and unfastening, and for looping attachment of the actuator cuff.

35. A counterpulsation device as in claim 28, wherein a thickness of the upper and lower sections are each, including on each, the flexible surface layer, flexible bladder section, and flexible liner layer, in the range of 0.1 and 3.0 inches at a thickest point.

36. A counterpulsation device as in claim 28, wherein a longest width of the upper section is between 2.0 and 20.0 inches and wherein a longest length of the upper section is in the range of 5.0 and 30.0 inches.

37. A counterpulsation device as in claim 28, wherein a longest width of the lower section is between 2.0 and 20.0 inches and wherein a longest length of the lower section is in the range of 10.0 and 40.0 inches.