Medical inflatable cuff appliance

• US 5,584,798 A
• Filed: 03/31/1995
• Issued: 12/17/1996
• Est. Priority Date: 11/23/1992
• Status: Expired due to Term

• Current Assignee: Covidien AG (Medtronic Plc)
• Original Assignee: Novamedix Limited (Orthofix Medical Inc.)
• Inventors: Fox, Roger H.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US08/414,753
• Time in Patent Office: 627 Days
• Field of Search: 601/148, 601/149, 601/150, 601/151, 601/152
• US Class Current: 601/152
• CPC Class Codes: A61H 2205/12 Feet
• 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

Apparatus for therapeutically or prophylactically treating a diagnosed or potential deep-vein thrombosis involves intermittent application of tourniquet action to the leg at a location preferably close to the ankle, i.e., at the distal-calf region of the leg, in time-coordinated relation to artificially stimulated foot-pump action; the level of tourniquet action is such as to reduce the availability of superficial veins to carry the venous-return flow that is stimulated by foot-pump action, and the level of tourniquet action is also insufficient to materially affect access to deep-veins which are the primary target of therapeutic or prophylactic treatment.

In a modification, the sequencing of tourniquet and foot-pump action is changed to enhance the priming of blood in the plantar veins of a foot which must remain elevated above the heart level of a patient confined to bed, whereby circulation can be more effectively stimulated by foot-pump action.

Claims

1. Medical apparatus for therapeutically and/or prophylactically treating a blood-circulation abnormality in a patient'"'"'s leg, comprising a single inflatable cuff adapted for application to the calf, first means for transiently inflating said cuff to a first pressure level sufficient to induce local tourniquet-pressure action on the calf, an inflatable foot-pump adapted for application of inflation pressure primarily at the plantar region between the ball and heel of the foot, second means for transiently inflating said foot-pump to a peak pressure in excess of said first pressure level, and cyclically operable control means for coordinated inflation/deflation cyclical operation of said first and second means, said control means including separate means of pressure-fluid supply only to said single inflatable cuff and to said inflatable foot-pump, and said control means being for sequential operation of only said single inflatable cuff and said inflatable foot-pump in each cyclical operation such that:

(a) initially, via said first means, said cuff is supplied with pressure fluid to transiently retain tourniquet-pressure action on the calf;

(b) via said second means, said foot-pump is transiently inflated to said peak pressure in the circumstance of said tourniquet-pressure action on the calf, and said foot-pump is relieved of inflation pressure after achievement of said peak pressure; and

(c) via said first means, cuff pressure is relieved from tourniquet action in selectively timed relation to inflation and at least commencement of relief of foot-pump pressure;

said control means providing a cycle-completing interval of time between said control operations via said first and second means prior to control-means re-initiation of the next-succeeding cyclical operation, wherein successive cycles recur at a periodic interval which is in the range of 5 to 60 seconds.

2. Medical apparatus according to claim 1, in which said control means includes selectively operable means for relief of foot-pump pressure in the range of substantially zero to five seconds following achievement of said peak pressure.

3. Medical apparatus according to claim 1, in which said control means includes selectively operable means for inflating and holding the inflation of said cuff over a period of time that exceeds the period of time of foot-pump inflation and relief from said peak pressure.

4. Medical apparatus according to claim 1, for treating a leg which is supported in a raised position above the level of bed support for the patient'"'"'s body, said control means including selectively operable means for inflating and retaining tourniquet pressure on the calf for a period of time immediately prior to foot-pump inflation.

5. Medical apparatus according to claim 1, for treating a DVT condition in the leg at a location that is proximal with respect to cuff application to the calf, said control means including selectively operable means for retaining said cuff pressure substantially only during a period of also inflating said foot-pump to peak pressure and substantially relieving said foot-pump from peak pressure.

6. Medical apparatus according to claim 1, in which said control means includes selectively operable means for retaining inflated-cuff pressure in at least some timed concurrence with inflation of said foot-pump to peak pressure and relief of said foot-pump from peak pressure.

7. Medical apparatus according to claim 1, in which said control means includes selectively operable means for initiating the inflation of said cuff prior to initiating the inflation of said foot-pump and for initiating the relief of foot-pump pressure prior to initiating the relief of cuff-pressure.

8. Medical apparatus according to claim 2, in which said selectively operable means includes means for selecting at least one setting from the group consisting of zero seconds, one second, two seconds, three seconds, four seconds, and five seconds.

9. Medical apparatus according to claim 2, in which the periodic interval of recurrent cycling is substantially 20 seconds.

10. Medical apparatus according to claim 1, in which the transient inflation of said cuff is at a rate slower than the transient inflation of said foot-pump.

11. Medical apparatus according to claim 1, in which the transient inflation of said foot-pump is effected within one second.

12. Medical apparatus according to claim 1, in which the transient inflation of said foot-pump is effected within 0.5 second or less.

13. Medical apparatus according to claim 11, in which the transient inflation of said cuff is effected within no less than one second.

14. Medical apparatus according to claim 1, in which the level of tourniquet-pressure action is in the range of 30 to 100 mm Hg.

15. Medical apparatus according to claim 1, in which the level of tourniquet-pressure action is in the range of 40 to 60-mm Hg.

16. Medical apparatus according to claim 1, in which the peak-pressure level of foot-pump inflation is in the range up to substantially 225-mm Hg.

17. Medical apparatus according to claim 1, in which the peak-pressure level of foot-pump inflation is at least substantially 200-mm Hg.

18. Medical apparatus according to claim 1, in which said control means includes a timing device preset to determine the sequential operations of said cuff and of said foot-pump as well as the periodic interval of recurrent cycling.

19. Medical apparatus according to claim 1, in which said control means includes pressure-responsive means connected for response to instantaneous cuff pressure for initiating inflation of said foot-pump upon detected achievement of said first-pressure level of cuff inflation.

20. Medical apparatus according to claim 1, in which said control means includes pressure-responsive means connected for response to the difference between cuff pressure and instantaneous foot-pump pressure for initiating deflation of said cuff upon detected reduction of instantaneous foot-pump pressure to the instantaneous level of cuff pressure.

21. Medical apparatus according to claim 1, in which said control means includes selectively operable means for relieft of foot-pump pressure in the range of substantially zero to five seconds following achievemen of said peak pressure.

22. Medical apparatus for treatment of a DVT or the like condition in a patient'"'"'s leg, comprising a single inflatable cuff adapted for application to the calf at a location distal to the DVT, first means for transiently inflating said cuff to a first pressure level sufficient to induce local tourniquet-pressure action on the calf, an inflatable foot-pump adapted for application of inflation pressure primarily at the plantar region between the ball and heel of the foot, second means for transiently inflating said foot-pump to a peak pressure in excess of said first pressure level, and cyclically operable control means for coordinated inflation/deflation cyclical operation of said first and second means, said control means including separate means of pressure-fluid supply only to said single inflatable cuff and to said inflatable foot-pump, and said control means being for sequential operation of only said single inflatable cuff and said inflatable foot pump in each cyclical operation such that:

(a) initially, via said first means, said cuff is supplied with pressure fluid to transiently retain tourniquet-pressure action on the calf;

(b) via said second means, said foot-pump is transiently inflated to said peak pressure in the circumstance of said tourniquet-pressure action on the calf, and said foot-pump is relieved of inflation pressure after achievement of said peak pressure; and

(c) via said first means, cuff pressure is relieved from tourniquet action in selectively timed relation to inflation and at least commencement of relief of foot-pump pressure;

said control means providing a cycle-completing interval of time between said control operations via said first and second means prior to control-means re-initiation of the next-succeeding cyclical operation, wherein successive cycles recur at a periodic interval which is in the range of 15 to 60 seconds.

23. Medical apparatus for treatment of a DVT or the like condition in a patient'"'"'s leg, comprising an inflatable cuff adapted for application to the calf at a location distal to the DVT, first means for transiently inflating said cuff to a first pressure level sufficient to induce local tourniquet-pressure action on the calf, an inflatable foot-pump adapted for application of inflation pressure primarily at the plantar region between the ball and heel of the foot, second means for transiently inflating said foot-pump to a peak pressure in excess of said first pressure level, and cyclically operable control means for coordinated inflation/deflation cyclical operation of said first and second means, said control means including separate means of pressure-fluid supply to said inflatable cuff and to said inflatable foot-pump, and said control means being for sequential operation in each cyclical operation such that:

(a) initially, via said first means, said cuff is supplied with pressure fluid to transiently retain tourniquet-pressure action on the calf;

(b) via said second means, said foot-pump is transiently inflated to said peak pressure in the circumstance of said tourniquet-pressure action on the calf, and said foot-pump is relieved of inflation pressure after achievement of said peak pressure;

said control means including pressure responsive means connected for response to the difference between cuff pressure and instantaneous foot-pump pressure for initiating deflation of said cuff upon detected reduction of instantaneous foot-pump pressure to the instantaneous level of cuff pressure; and

said control means providing a cycle-completing interval of time between said control operations via said first and second means prior to control-means re-initiation of the next-succeeding cyclical operation, wherein successive cycles recur at a periodic interval which is in the range of 15 to 60 seconds.

24. Medical appliance for therapeutically and/or prophylactically treating a blood-circulation abnormality in a patient'"'"'s leg, comprising an inflatable cuff adapted for application to the calf, first means for transiently inflating said cuff to a first pressure level sufficient to induce local tourniquet-pressure action on the calf, an inflatable foot-pump adapted for application of inflation pressure primarily at the plantar region between the ball and heel of the foot, second means for transiently inflating said foot pump to a peak pressure in excess of said first pressure level, and cyclically operable control means for coordinated inflation/deflation cyclical operation of said first and second means, said control means including separate means of pressure-fluid supply to said inflatable cuff and to said inflatable foot-pump, and said control means being for sequential operation in each cyclical operation such that:

(a) initially, via said first means, said cuff is supplied with pressure fluid to transiently retain tourniquet-pressure action on the calf;

(b) via said second means, said foot-pump is transiently inflated to said peak pressure in the circumstance of said tourniquet-pressure action on the calf, and said foot-pump is relieved of inflation pressure after achievement of said peak pressure;

said control means including pressure-responsive means connected for response to the difference between cuff pressure and instantaneous foot-pump pressure for initiating deflation of said cuff upon detected reduction of instantaneous foot-pump pressure to the instantaneous level of cuff pressure; and

said control means providing a cycle-completing interval of time between said control operations via said first and second means prior to control-means re-initiation of the next-succeeding cyclical operation, wherein successive cycles recur at a periodic interval which is in the range of 15 to 60 seconds.

25. Medical apparatus according to claim 24, in which said control means includes selectively operable means for relief of foot-pump pressure in the range of substantially zero to five seconds following achievement of said peak pressure.