U.S. patent number 3,901,221 [Application Number 05/459,130] was granted by the patent office on 1975-08-26 for pressure cycle for stimulating blood circulation in the limbs.
This patent grant is currently assigned to Clinical Technology International, Inc.. Invention is credited to Charles S. Lipson, James E. Nicholson.
United States Patent |
3,901,221 |
Nicholson , et al. |
August 26, 1975 |
Pressure cycle for stimulating blood circulation in the limbs
Abstract
A method of cycling pressure applied externally to a mammalian
limb to obtain high amplitude surges of blood. A fast rise time
followed by a holding period and a relatively long relaxation
interval is utilized.
Inventors: |
Nicholson; James E. (Quincy,
MA), Lipson; Charles S. (Newton, MA) |
Assignee: |
Clinical Technology International,
Inc. (Canton, MA)
|
Family
ID: |
23823525 |
Appl.
No.: |
05/459,130 |
Filed: |
April 8, 1974 |
Current U.S.
Class: |
601/152 |
Current CPC
Class: |
A61H
9/0078 (20130101) |
Current International
Class: |
A61H
23/04 (20060101); A61H 001/00 () |
Field of
Search: |
;128/24R,60,297-299,44 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; Lawrence W.
Attorney, Agent or Firm: Tarrant; Thomas N.
Claims
We claim:
1. A method of overcoming circulatory stasis in mammalian limbs
comprising:
a. Applying to a limb portion fluid pressure of at least 30 mm of
mercury over a time interval of between 9 and 15 seconds with a
rise time reaching 30 mm of mercury within 3 seconds;
b. keeping the applied pressure below 1 mm of mercury over a time
interval of 30 to 60 seconds; and
c. cyclically repeating the above steps.
2. A method according to claim 1 wherein said pressure is applied
for substantially 12 seconds and removed for substantially 48
seconds in repeating cyclical fashion.
3. A method according to claim 1 wherein said fluid pressure is in
the range of 40 to 50 mm of mercury and has an inflation rate
reaching at least 10 mm of mercury per second for at least 3
seconds.
4. A method according to claim 3 wherein said fluid is a gas.
5. A method according to claim 4 in which said fluid is applied by
means of a plastic garment enclosing a limb extremity.
6. A method according to claim 4 wherein at the end of the said
time interval over which the fluid pressure in the range of 40 to
50 mm of mercury is applied, the pressure is released falling to 10
mm of mercury in about 2 seconds and then more slowly to 0 mm of
mercury.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to pressure garments used to apply cyclical
pressure to mammalian extremities for the purpose of overcoming
circulatory defficiency and particularly to a pressure cycling
method.
2. Relation to the Prior Art
Roberts et al ("The Effect of Intermittently Applied External
Pressure on the Haemodynamics of the Lower Limb in Man", British
Journal of Surgery, 1972, Vol. 59, No. 3 March) disclosed that when
pressure was applied to the legs with an inflatable plastic splint,
increase in peak venous flow was directly proportional to the rate
of pressure application. He purported to demonstrate that the peak
increase in blood flow was maximal at an inflation rate of 10 mm.
Hg. per second and the maximums in pulsatility and peak flow
required an approximate interval of one minute between applications
of pressure.
The primary interest in such dynamic stimulation of blood today is
to combat the high rate of postoperative deep-vein thrombosis. The
formation of dangerous thrombi is promoted by pockets of blood
stasis. Blood stasis in the limbs is normally prevented by physical
activity. Since surgery both prevents normal activity and exposes
the system to coagulant stimulating effects, a high rate of
thrombosis results. Increasing peak flow and pulsatility tends to
overcome pockets of stasis.
While Roberts et al. disclose conditions of peak increased flow and
maximum increase in pulsatility with respect to repetition
intervals, they neglect the amplitude of flow during each pressure
application concerning themselves only with peak increase.
SUMMARY OF THE INVENTION
In accordance with the present invention, it has been found that
blood stasis pockets in the veins of mammalian extremities occur
particularly behind the cusps which form the directional valves of
the veins. It has been found that optimum disturbance of stasis
behind these cusps is obtained when pulses of increased flow level
have a maximum amplitude; that is, when as large a quantity of
blood as is comfortable passes these cusps during a given pulse. It
has been found that this result can be obtained by applying
pressure through a pressure garment with a rise time of at least 10
mm of mercury per second and a holding time at the level of at
least 30 mm of mercury for at least 8 seconds. A cycle period of
one minute is near optimum.
Thus, it is an object of the present invention to provide a novel
pressure cycling method for cycling pressure garments so as to
overcome blood stasis in mammalian extremities.
It is a further object of the present invention to provide a method
of pressure cycling for application to the external mammalian limb
to maximize the amplitude of increased flow pulses by a pressure
holding time of at least 8 seconds.
Further objects and features of the invention will become apparent
upon reading the following description together with the
drawing.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is a graph of a controller pressure cycle according to the
invention.
FIG. 2 is a graph of femoral vein flow resulting from the pressure
cycle of FIG. 1.
FIG. 3 is a diagrammatical illustration depicting operation of the
invention.
FIG. 4 is a graph of exemplary internal boot pressure resulting
from the controller cycle of FIG. 1.
DESCRIPTION OF THE PREFERRED EMBODIMENT:
FIG. 1 is a graph of pressure at the cyclic controller output in
accordance with the preferred pressure cycle. When the pressure
line is connected to the boot by operation of a valve at time zero,
curve portion 10 indicates a rapid rise in less than 4 seconds to
greater than 30 mm of mercury. The pressure then climbs gradually
above 40 mm of mercury as indicated by curve 11 until 10 seconds is
reached at which point the pressurizing valve is closed and the
exhaust valve opening to the atmosphere is opened so that at 12
seconds the pressure has dropped below 10 mm as depicted by curve
12. For the following 48 second time period, depicted by curve 14,
no pressure is applied allowing the blood veins to refill. The
cycle repeats at 60 second intervals.
FIG. 2 depicts flow in the superficial femoral vein during the
pressure cycle of FIG. 1. Pulses 15 are normal blood pulsation
provided by the heart. The normal flow level, in the particular
instance depicted, averaged slightly over 50 milliliters per
minute. Upon application of pressure from the pressure boot, the
flow increased over an interval of approximately 2 seconds to
approximately 195 milliliters per minute, as indicated by curve 16.
Curve 17 depicts the slow dropping off virtually immediately after
reaching its peak. The pressure is released approximately at point
18 in the curve whereupon the flow drops to baseline level and
flows for a short interval at a rate less than baseline level as
indicated by inverted peak 20. The blood flow characteristics
remain below average normal blood flow for the following 28 seconds
as indicated by portion 21 of the graph. The blood then returns to
the normal flow characteristics prior to the next pressure pulse
depicted by curve 22.
The operation of the present invention is best understood by
description of its utilization with a human being. Referring to
FIG. 3, a patient 25, depicted as lying down, wears a boot 26
enclosing his foot and lower leg to the vicinity of the knee and
also a mitten 27 enclosing his hand and forearm. Both boot and
mitten are made of outer and inner layer with an inflatable space
therebetween. The outer layer in each case has limited
expandability so that, upon inflation, pressure is directed inward
against the enclosed limb. Boot 26 and mitten 27 are inflated
through hoses 28 from a pressure tank 30. Pressure tank 30 may be
connected to a pump for continuous duty use. Between pressure tank
30 and hoses 28 is a cyclic controller 34 for applying and
releasing pressure in accordance with the graph in FIG. 1.
FIG. 3 depicts operation of one boot and one mitten. The pressure
cycling of the invention can be applied to any one or more of the
four limbs.
FIG. 4 shows pressure measured inside a boot during a controller
pressure cycle according to FIG. 1. The rise time inside the boot
is 40 mm Hg. in approximately 4 seconds as shown in curve 35. The
fall time shown by curve 36 is likewise a little slower falling to
10 mm Hg. in about 2 seconds and then curving exponentially to 0
over the next 8 seconds.
While the invention has been described in accordance with a
preferred embodiment, some latitude in the operation of the cycle
is desirable depending on specific patients and conditions. A rapid
boot pressure rise to at least 30 mm of mercury produces near
optimum results when extended over 3 seconds. With particularly
sensitive patients, this rise may be extended out to 5 seconds to
reduce discomfort. Similarly, the maximum pressure attained is
desirably between 40 and 50 mm of mercury, but a peak of 30 mm of
mercury is sufficient for most cases. A range of 9 to 15 seconds is
acceptable for the time interval between the beginning of pressure
application and the onset of pressure release. For maximum effect
it is desirable to delay the next application of pressure until the
venous flow has returned to its normal equilibrium point, however,
this differs with the individual patient and may vary within a
fairly wide range with a total period between the cyclical
commencement of pressure application being anywhere from about 40
to 80 seconds. A period of 60 seconds is suitable for most
cases.
Using the pressure cycle depicted in FIG. 1, it has been found that
in an average case the total increase in blood flow over the 12
second interval beginning with the first application of pressure is
approximately 30% more than if the pressure is released immediately
after the peak pressure is attained. Thus the holding period after
attaining the peak pressure has a significant effect.
Having described a preferred example of the invention along with an
indication of the ranges of variation within its scope, the
following claims set forth the scope to be covered.
* * * * *