Devices and methods for non-invasively improving blood circulation

• US RE42,958 E1
• Filed: 07/17/2009
• Issued: 11/22/2011
• Est. Priority Date: 10/07/2003
• Status: Active Grant

• Current Assignee: CardioMAX, LLC
• Original Assignee: Cardiomedics, Inc.
• Inventors: Sullivan, Robert J., Perkins, Lawrence J., Johnson, Ginger, Burrell, John P., Loeb, Marvin P.
• Primary Examiner(s): Bertram; Eric D.
• Application Number:
  US12/460,438
• Time in Patent Office: 858 Days
• Field of Search: 600/17, 600/18, 601/149, 601/152, 606/201, 606/202, 606/204
• US Class Current: 600/17
• CPC Class Codes: A61H 2201/1621 Holding means therefor
• CPC Class Codes: A61H 2201/163 holding means therefor
• CPC Class Codes: A61H 2201/1642 Holding means therefor
• CPC Class Codes: A61H 2201/5002 Means for controlling a set of similar massage devices acting in sequence at different locations on a patient
• CPC Class Codes: A61H 2205/083 Abdomen
• CPC Class Codes: A61H 2205/084 Chest
• CPC Class Codes: A61H 2205/086 Buttocks
• CPC Class Codes: A61H 2205/10 Leg
• CPC Class Codes: A61H 2205/106 for the lower legs
• CPC Class Codes: A61H 2205/108 for the upper legs
• 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

Abstract

Circulatory assistance is provided in a non-invasive procedure safely and effectively using a microprocessor of an external counter pulsation device programmed to control the actuation of any or all of a plurality of valves, each of which is mounted on and in fluid communication with one of a plurality of individual inflatable bladders disposed in pockets within cuffs encasing the calves, thighs, buttocks, abdomen and/or chest of a person and an optional valve in fluid communication with the person'"'"'s airway, in any desired sequence or order, toward the heart or toward the feet, either during diastole or systole, at desired inception times during the cardiac cycle, for selected durations and at chosen pressures, for treating a variety of cardiac, non-cardiac and circulatory conditions.

Claims

1. A method of applying therapeutic pressure to exterior pressure points on a patient to treat a cardiovascular-related medical condition, the method comprising the steps of:

sensing the patient'"'"'s electrocardiogram and blood pressure and applying a selected magnitude of air pressure exteriorly to selected ones of the points on the patient during a selected time period during a cardiac cycle and controlling the peak diastolic pressure to peak systolic pressure ratio (D/S Ratio) wherein in the treatment of persons a patient with congestive heart failure and a left ventricular ejection fraction less than about 40%, to not exceed the heart'"'"'s capacity to eject a therapeutic portion of the blood in the heart'"'"'s ventricles, wherein the controlled D/S Ratio is held to not more than 0.7;

1 to 0.8;

1 during the first five hours of therapeutic pressure application.

2. The method of claim 1 further comprising the step of setting a residual pressure and maintaining said residual pressure in bladders engaged within cuffs on the pressure points of the patient.

3. The method of claim 2 further comprising the step of engaging a check valve on each of a plurality of air actuated valves to maintain a selected residual pressure in the bladders upon release of therapeutic pressure.

4. The method of claim 1 further comprising the step of selecting a sequence of therapeutic pressure applications to the pressure points on the patient from one of:

toward the heart and toward the feet.

5. The method of claim 1 further comprising the step of selecting a therapeutic pressure application initiation and completion during one of diastole and systole.

6. The method of claim 1 further comprising the step of selecting at least one point of therapeutic pressure application on a patient from the group of pressure points including the calves, thighs, buttocks, abdomen and chest.

7. The method of claim 1 further comprising the step of selecting a compression rate, compression therapeutic pressure and compression duration for each of the selected points of therapeutic pressure application in the absence of an ECG signal.

8. The method of claim 1 further comprising the step of adjusting intervals between therapeutic pressure applications on points.

9. The method of claim 1 further comprising the step of selecting and auto-maintaining a desired peak diastolic pressure to peak systolic pressure ratio by adjusting the magnitude of the therapeutic pressure application to the points on the patient.

10. The method of claim 9 further comprising the step of automatically adjusting the duration of a delay time from the “

r”

wave of a patient'"'"'s ECG and the duration of therapeutic pressure application to maintain a selected D/S Ratio.

11. The method of claim 1 further comprising the step of selecting one of an acceptable minimum and maximum qrs width.

12. The method of claim 1 further comprising the step of placing air actuated valves at each of the points on the patent and separately providing therapeutic air pressure application to bladders associated with each of the points on the patent through the air actuated valves.

13. The method of claim 1 further comprising the step of applying the therapeutic pressure to the points on a patient, wherein the points are at least one of:

the calves, thighs, buttocks, abdomen and chest.

14. The method of claim 1 further comprising the step of applying the therapeutic pressure, wherein at least one of the points is on the chest.

15. The method of claim 1 further comprising the step of applying the therapeutic pressure wherein at least one of the points is on the abdomen.

16. The method of claim 1 further comprising the steps of providing one of:

a mouthpiece, a nose pinch assembly, an intubation tube and a mask, over at least one of the patient'"'"'s nose and mouth;

further providing thereon, an air actuated valve and an air pressure regulator, and applying air pressure into the patient'"'"'s airway at a selected pressure, for a selected period of time and at a selected rate.

17. The method of claim 16 further comprising the step of setting an air pressure volume to be employed with one of the mouthpiece and nose pinch assembly, the intubation tube and the mask.

18. The method of claim 16 further comprising the step of applying an air pressure sensor feedback means for adjusting and maintaining a selected infusion volume.

19. The method of claim 16 further comprising the step of selecting one of a fixed plurality of pressure settings on the air pressure regulator.

20. The method of claim 16 further comprising the step of selecting a breath pressure, and breath rate.

21. The method of claim 1 further comprising the step of selecting a buttocks and a chest compression interval time for actuating the application of a therapeutic amount of pressure to each simultaneously for a selected duration.

22. The method of claim 1 further comprising the steps of selecting a function icon on the display screen;

sending a signal to the microprocessor, actuating inflation of selected bladders at the desired points on the patient in a selected order with a selected delay time and compression period and at a selected pressure.

23. The method of claim 22 further comprising the step of actuating at least one air actuated valve and admitting a second relatively lower therapeutic pressure air through at least one air actuated valve to at least one air bladder for applying therapeutic pressure to at least one point on the patient.

24. The method of claim 1 further comprising the step of alternately compressing at least one of the calves, thighs, buttocks and abdomen with the chest of a patient in cardiac arrest for selected time periods and therapeutic pressures in the absence or an ECG signal.

25. The method of claim 1 wherein the D/S Ratio is held to not more than 0.8:

1 to 0.9;

1 during a the next five to ten hour duration of therapeutic pressure application.

26. The method of claim 1 wherein the D/S Ratio is held to not more than 0.9:

1 to 1.3;

1 during a the remainder 35 hour therapeutic pressure application.

27. The method of claim 1 wherein the therapeutic pressure application is held to not more frequent than one hour per day.

28. The method of claim 1 wherein the therapeutic pressure application is held to not more frequent than one hour every other day.

29. The method of claim 1 wherein in treating septic shock, at least two of the calves, thighs, buttocks and abdomen of a patient are therapeutically compressed during systole in a sequence moving toward the heart.

30. The method of claim 1 wherein in treating peripheral edema, at least two of the calves, thighs, buttocks and abdomen of a patient are sequentially compressed during one of systole and diastole in a sequence moving in the direction of one of toward the heart and toward the feet.

31. The method of claim 1 wherein in treating a patient in whom a femoral catheter is deployed, a therapeutic pressure is applied only to the calves and thighs of said patient.

32. The method of claim 1 further comprising the step of, for a person with congestive heart failure, reducing the patient'"'"'s target D/S ratio in proportion to the degree the patient'"'"'s left ventricular ejection fraction is below about 40%.

33. The method of claim 1, wherein in a 35 hour treatment of congestive heart failure:

(a) the D/S Ratio is held to not more than 0.7;

1 during the first 5 hours, 0.8;

1 during the next 5 to 10 hours, and 0.9;

1 to 1;

1 for the remainder of the 35 hour treatment of therapeutic pressure applications to enable the heart to gradually eject a greater volume of blood; and

(b) if the patient'"'"'s LVEF is more than 40% after the first 10 to 15 hours, increasing for the remainder of the treatment the D/S Ratio to no more than 1.2;

1.

34. The method of claim 1, comprising the further steps of:

(a) transmitting data on the patient'"'"'s metabolic and cardiopulmonary function to a microprocessor to control the applied therapeutic pressure at the specified D/S Ratio;

wherein the data comprises at least one of;

i) the person'"'"'s heart rate and heart rate trend from the patient'"'"'s ECG;

ii) at least one of the patient'"'"'s VE/VCO2, VO2, ETCO2, and VCO2, and the patient'"'"'s respiration rate obtained from a multifunctional sensor disposed within one of;

a mask over the patient'"'"'s nose and mouth, a mouthpiece and nose pinch assembly and an intubation tube assembly; and

(b) utilizing said data by the microprocessor to adjust and maintain the exteriorly applied therapeutic pressure from a chest cuff to maintain said D/S Ratios.

35. The method of claim 1 wherein in the treatment of congestive heart failure, the average D/S ratio is held over the therapeutic pressure applications to less than 1:

1.

36. The method of claim 3, comprising the further step of applying a vacuum to draw air out of said bladders upon release of the therapeutic pressure.

37. The method of claim 1, wherein said therapeutic pressure is applied for one of:

about one hour each 12 to 24 hours, about one hour per day and about one hour every other day at a D/S Ratio selected to one of;

inducing angiogenesis, increasing intra-coronary artery pressure and forcing blood through collateral vessels and around blockages in said arteries and not exceeding the heart'"'"'s capacity to eject a therapeutic amount of blood in the heart'"'"'s ventricles.

38. The method of claim 1, wherein when the medical condition comprises gangrene of at least one of the calf, ankle and foot, said therapeutic pressure is sequentially applied to only the thighs and buttocks of the patient in the direction of one of:

toward the heart and toward the feet, without applying therapeutic pressure to the calf.