U.S. patent number 3,654,919 [Application Number 05/092,606] was granted by the patent office on 1972-04-11 for process and apparatus for synchronous assisting of blood circulation.
This patent grant is currently assigned to Medical Innovations, Inc.. Invention is credited to William Clifford Birtwell.
United States Patent |
3,654,919 |
Birtwell |
April 11, 1972 |
PROCESS AND APPARATUS FOR SYNCHRONOUS ASSISTING OF BLOOD
CIRCULATION
Abstract
Apparatus useful in enhancing or assisting the circulation of
blood, reducing the work of the heart and increasing the coronary
blood flow, said apparatus comprising a rigid, incompressible
system which provides an external pulsatile pressure environment on
a portion of the body which is synchronous and phased with cardiac
action. A rigid chamber or chambers with a liquid filled system of
non-distensible, yet expandable, seals houses a portion of the body
(e.g., the limbs) in such a way that the pressure exerted on the
body can be varied above and below atmospheric pressure by adding
or removing liquid from the system.
Inventors: |
Birtwell; William Clifford
(North Scituate, RI) |
Assignee: |
Medical Innovations, Inc.
(Newton, MA)
|
Family
ID: |
22234083 |
Appl.
No.: |
05/092,606 |
Filed: |
November 25, 1970 |
Current U.S.
Class: |
601/152;
601/151 |
Current CPC
Class: |
A61H
9/0078 (20130101) |
Current International
Class: |
A61H
23/04 (20060101); A61h 007/00 () |
Field of
Search: |
;128/24R,24.1,40,64,30,30.2 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; L. W.
Claims
What is claimed is:
1. Apparatus for use in external synchronous assisting of the
circulation of blood in a patient, said apparatus comprising
A. a rigid housing forming means to house a portion of a patient's
body;
B. hydraulic compression and decompression means to cycle the
pressure on said portion of a patient's body;
C. suction-producing means to provide a substantially gas-free
environment for said compression and decompression means and
D. means to synchronize the overriding of said sub-atmospheric
pressure with the patient's heartbeat.
2. Apparatus as defined in claim 1 wherein the hydraulic
compression means comprises (A) expansible seal bags containing a
volume of substantially non-compressible fluid which is in
hydraulic communication with hydraulic means for increasing and
decreasing the volume thereof and thereby expanding and contracting
said expansible seal bags and (B) passive seal bags also containing
a substantially non-compressible liquid and wherein the expansible
seal bags are so arranged with respect to the passive seal bags
that expansion of the former results in hydraulic pressure being
exerted on the latter; said seal bags being enclosed in said rigid
housing.
3. Apparatus as defined in claim 2 wherein the rigid housing is
shaped for receiving a patient's limb and is divided into a larger
circumferential segment, the expansible seal bags being supported
on the smaller segment and the passive seal bags being affixed to
the larger segment.
4. Apparatus as defined in claim 3 wherein said smaller
circumferential segments of said leg housings are integrally
attached to a suction-producing and hydraulic compression means
mounted in a V-section formed by said leg housings.
5. Apparatus as defined in claim 2 wherein said housing is shaped
for receiving a patient's limb and said passive seal bag comprises
a plurality of tethering means running longitudinally therealong
and connecting the walls of said passive seal which is affixed to
said larger circumferential segments of said rigid casing.
6. Apparatus as defined in claim 3 wherein said smaller
circumferential casing segments form an arc of up to about
120.degree. and said larger circumferential casing segments form an
arc of more than about 240.degree. and wherein the larger segments
are pivotally mounted on said smaller segments.
7. Apparatus useful in providing a continuous suction and a
fluctuating hydraulic pressure to a treating zone, said apparatus
characterized by its compactness and freedom from excess mechanical
action and comprising, in integral relation with one another
A. a reciprocating piston mounted for movement in a housing between
a suction zone and a hydraulic zone, said piston bearing seal means
to maintain separation of one said zone from the other;
B. a vacuum accumulator chamber mounted adjacent to said housing
and separated therefrom by a plate;
C. a check valve mounted in said plate for diminishing leakage of
air from said suction zone to said accumulator chamber;
D. means for actuating said piston mounted in said vacuum
accumulator chamber and
E. said hydraulic zone being bounded by said piston on one side
thereof and by a bottom plate assembly comprising a convex plate
facing said hydraulic zone and a flat plate proximate the
circumference thereof.
8. Apparatus as defined in claim 1 wherein said means for providing
gas-free environment comprises a non-constrictive suction-activated
seal means.
9. Apparatus as defined in claim 1 wherein said expansible seal
bags are constructed of substantially inelastic material.
10. Apparatus as defined in claim 2 wherein said means for
providing a gas-free environment comprise a non-constrictive,
suction-activated seal means and wherein said expansible seal bags
are constituted of a substantially inelastic material.
11. In a process for externally assisting the circulation of blood
by a synchronously actuated assist to the pumping action of the
heart, by application of pulsatile pressure to a portion of a
patient's body, the improvement consisting of applying said
pulsatile pressure through a non-compressible liquid pre-positioned
in inflatible but substantially non-elastic containers, while said
containers envelope substantially all said patient's legs, and
continuously applying a vacuum to remove any compressible gases
from the environment of said body portion and thereby providing
that the internal pressure of the patient's body and said pulsatile
pressure are the only forces substantially effecting the blood
circulation in said portion of said body.
12. A process as defined in claim 11 wherein said mean pressure on
said legs is maintained at or below atmospheric pressure.
13. A process as defined in claim 11 wherein said compressive
forces are transmitted through a compressing liquid medium and
wherein a major portion of said compressing liquid is
pre-positioned in passive sealing bags mounted proximate said legs
and a minor portion of said compressing liquid is in direct
hydraulic contact with a piston means, thereby minimizing the
quantity of liquid which must be moved by the piston means.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a novel apparatus for assisting blood
flow through the circulatory system by synchronizing the pulsing of
an external assist means with the heartbeat. The invention also
relates to a novel process achieved by use of the apparatus.
2. Background of the Invention
Methods for atraumatically assisting blood circulation of patients
have been described in the art. In U.S. Pat. No. 3,303,841 to
Dennis, a process is described whereby an external compressing of
the lower part of the body expresses a volume of blood larger than
the volume of blood pumped in a single stroke of the heart. The
blood so expressed is forced back into the aorta and greater
arterial vessels and thereby allows a reduction in ventricular
workload while maintaining a satisfactory perfusion of blood during
ventricular diastole. This general type of process has been
elaborated upon in an article entitled "Synchronous Assisted
Circulation" by Birtwell et al. appearing in the The Canadian
Medical Association Journal (Vol. 95, pages 652-664) on Sept. 24,
1966. In general, synchronous external pressure assist processes
are distinguishable and advantageous over pre-existing
counter-pulsation processes because the latter kind of procedure
involves the cannulation of a major artery, use of an
extra-corporeal blood handling device, the use of stringently
sterile techniques and the necessity of administering
anti-coagulants to the patient. Moreover, the blood trauma or
hemolysis produced by extracorporeal pumping devices limits
permissible duration of the assist procedure and compromises the
condition of the patient. These procedures are not only
time-consuming but can present a real hazard to many patients and
increase the risk factor in treating all patients.
Specific apparatus usable in a synchronous assist process is
disclosed in U.S. Pat. No. 3,403,673 to MacLeod. In general, the
apparatus consists of a leg-encasing arrangement with means for
cycling the pressure on the legs within the casing. The invention
described in U.S. Pat. No. 3,403,673 has a number of problems
associated with its use. For example, the constrictive type seals
thereof are believed to interfere with optimum blood circulation.
Moreover, the inertia of the pressurizing system which includes
elastic type expansible linings is believed to interfere with
obtaining an optimum pressure-time profile on the legs.
The apparatus suggested in the prior art has a number of drawbacks
in that it is cumbersome to use, i.e., the patient is inserted into
and removed from the device with excessive effort; and it is
excessively difficult to achieve the proper pressure-pulsation
profile and impossible to achieve what the inventors believe is the
more advantageous mode of operation, i.e. at an ambient pressure at
or below atmospheric pressure.
It is important that such problems be solved economically but
without using means which expose the patient to undue physical
strain.
SUMMARY OF THE INVENTION
Therefore, it is an object of the invention to provide a novel
process for synchronously assisting blood circulation by external
pressure variation on the limbs of a patient.
It is a further object of the invention to provide an improved
apparatus useful in synchronously assisting blood circulation.
Another object of the invention is to provide improved apparatus
capable of being controlled to maintain a lower mean or reference
pressure than has heretofore been obtainable on that part of a
patient's body being subjected to external pressure variation.
Another object of the invention is to provide apparatus capable of
maintaining a pulsed pressure at more nearly the pressure profile
desired for a particular patient.
Still another object of the invention is to provide an apparatus
into which the patient can be placed or from which the patient can
be removed with relative ease and comfort.
A further object of the invention is to provide an apparatus which
does not allow the external pressure variation to impart an
undesirable movement to the patient being treated therewith.
Another object of the invention is to increase the output of the
coronary vasculature.
Another object of the invention is to achieve the foregoing objects
with a relatively compact apparatus.
Other objects of the invention will be obvious to those skilled in
the art on reading this application.
The present invention is partly based on the discovery that the
coronary vasculature can be made to produce a higher volume of
blood flow when the pressure of blood flowing thereto is
artifically modified. Ordinarily during the heartbeat, there is a
"muscular squeeze" on the vasculature during cardiac systole which
reduces its output somewhat. By use of the apparatus of the
invention, it has been found that the capacity of a portion of the
arterial system can be increased during systole and the vascular
resistance and pressure exerted by the left ventricle can be
lowered. During cardiac diastole, the capacity of the aforesaid
portion of arterial system can be decreased, thus returning blood
to the aorta and thereby increasing diastolic pressure and
perfusion flow.
It is also believed that the "collateral circulation" system (i.e.
"spare vessels" which normally do not provide very significant
blood flow but which ordinarily come into important operation when
a damaged vascular system is attempting to repair itself) is caused
to function during the diastole phase of the external pressure
assist process of the invention.
The above objects have been substantially achieved by the
construction of apparatus for assisting circulation by synchronous
pulsation which apparatus is constructed of a receiving compartment
for a portion of a patient's body which compartment comprises
therein active inflatable seal bags and passive seal bags through
which pressure can be exerted, e.g. most conveniently on the
patient's limbs. The active seal bags contain a non-compressible
liquid such as water and are in direct hydraulic communication with
a piston means for increasing the water content and consequently
the volume of the expansible bags. The liquid in the passive seal
bags, which are pressurized by the pressure exerted by the
expansion of the active bags, is fully enclosed. Means are provided
for keeping air out of the limb-receiving compartment during
operation of the device. In operation, negative pressure may be
achieved immediately adjacent the limbs and then be overridden
during that part of an operating cycle when expansion of the active
seal bags causes them to bear against the passive seal bags and
thereby transmit pressure completely around the legs.
As used above, "inflatable" is meant to define seal bags as being
expandable when fluid is injected thereinto. It is not meant to
suggest that the bags are constructed of elastic, i.e. rubber-like
material. In fact, such distendable materials are not preferred
because their distension would add to the inertia of the system and
reduce the capability of the system to conform to desired cycle
patterns.
It has been discovered that the ability to achieve a low-pressure
condition in the limb-receiving compartment contributes to improved
pressure cycle control and also to an improved mode of operation
whereby the mean pressure on the leg may be maintained at a low
level, preferably at or below atmospheric pressure. This mode of
operation is highly desirable because it reduces the undesirable
restriction of blood flow which can be experienced at the higher
operating pressures required when previously known synchronous
assist devices are utilized.
A particular advantage of the apparatus of the invention is the
construction whereby leg-holding compartments are formed into a
stationary compartment formed of a smaller casing segment and a
larger casing segment. The smaller casing segment, advantageously
not more than about 150 angular degrees and preferably not more
than 120 angular degrees, carries the active inflatable hydraulic
seal bags; the larger passive seal bags are attached to the larger
casing segments which are pivotally mounted for quick and
convenient enclosing of a patient's legs once they have been rested
on the expansible seal bags.
Another particularly advantageous feature of the invention is the
fact that the continuous availability of vacuum to the system
allows excellent control of the pressure cycle on the leg of the
patient. The inertial problems with use of apparatus comprising a
single pneumatic or hydraulic pressure control system are largely
avoided.
It has been discovered that, to avoid excessive movement of the
patient by the pressure-pulsing operation, the passive seal bags
should have the opposing internal sides thereof tethered together.
Such tethering substantially alleviates the tendency of the
apparatus to propel the patient out of the device with each
pressure pulse.
ILLUSTRATIVE EMBODIMENT OF THE INVENTION
In this application and accompanying drawings, there is shown and
described a preferred embodiment of the invention and there are
suggested various alternatives and modifications thereof, but it is
to be understood that these are not intended to be exhaustive and
that other changes and modifications can be made within the scope
of the invention. These suggestions herein are selected and
included for purposes of illustration in order that others skilled
in the art will more fully understand the invention and the
principles thereof and will be able to modify it and embody it in a
variety of forms, each as may be best suited in the condition of a
particular case.
In the drawings
FIG. 1 is a schematic diagram explanatory of the operation of the
apparatus of the invention.
FIG. 2 is a view showing the placement of a patient in relationship
to the apparatus of the invention.
FIG. 3 is a section of the liquid-containing seal bags and rigid
enclosure therefor, the bags being in non-expanded position.
FIG. 4 is a view similar to that shown in FIG. 3 with the bags
being in expanded position.
FIG. 5 is a perspective view of the passive seal bags used in the
invention.
FIG. 6 is a section, in perspective, of the pressure-pulsing system
of the apparatus of the invention.
FIG. 7 is a partly exploded view showing how the device of the
invention fits onto and hydraulically communicates with the leg
encasing members of the apparatus.
Referring to FIG. 1, it is seen that a pulsed signal input is
received along conduit 18 from a cardiac pulser section 20. This
pulser section forms means to receive, screen and transmit signals
from an electrocardiogram apparatus so that the apparatus of the
invention will be properly synchronized with the heartbeat of a
patient being treated.
The signal input is received by a solenoid valve control system 22
which controls the flow of hydraulic fluid through conduit 23 to
either side of master control piston 24 through hydraulic
sub-circuits 26 and 28 each of which comprises control valves 29 to
adjust the rate at which fluid is applied to piston 24.
Hydraulic fluid flowing through sub-circuit 26 is applied to face
30 of piston 24 causing the piston to move to the left. Conversely,
hydraulic fluid flowing through sub-circuit 26 is applied to face
32 of piston 24 causing the piston to move to the right. A
rightward movement of the piston causes a double bellofram-type
piston 34 to move rightward also. This movement of piston 34 causes
liquid contained in liquid seal system 36 to be driven into the
active, i.e. expandable, seal bags 38 by face 40 of piston 34. At
the same time, the other face 42 of piston 34 moves to the right
and tends to increase the availability of vacuum to the rigid legs
housings which hold the seal bags 58.
When hydraulic fluid is applied to face 30 of piston 24 causing the
piston 24 to move to the left, the liquid pressure in liquid seal
bags 38 is quickly reduced and, simultaneously, the movement of
face 42 of the piston 34 to the left tends to expel some air in
vacuum system 44. A vacuum accumulator 48 maintained at
sub-atmospheric pressure is used to dampen out fluctuations in
vacuum magnitude. The reduction in liquid pressure in seal bags 38
results in a sub-atmospheric pressure being exerted on the leg,
assuming, of course, that the vacuum system does not permit any
substantial quantity of gas to be present therein.
In practice, it will be understood, the immediate environment of
the leg will be at a sub-atmospheric pressure only until the
repressurization of the legs is caused by the movement of piston
face 40 to the right, the resultant movement of fluid into active
leg seal bags 38 and the consequent expansion of these bags.
FIGS. 2,3,4 and 5 are illustrative of the arrangement whereby a
pressure-expansible, i.e. active, seal bag 38 is held, together
with a passive seal bag 52, within a rigid casing 54 consisting of
a fixed smaller casing segment 56 and a pivotally mounted larger
casing segment 58. As shown in FIGS. 2 and 7, smaller casing
segments 56 are integrally mounted with the pressure control module
60.
Referring to FIG. 3, it is seen that active seal bags 38 are
attached on smaller casing segments 56. After the leg 62 to be
treated is rested on seal bag 38, the passive seal bag 52 is placed
over the leg 62, larger casing segment 58 is pivoted inwardly to
close over passive seal bag 52 and complete formation of the rigid
casing 54.
At this point, as best seen in FIG. 3, there is no compression of
the leg; indeed, the leg ordinarily expands somewhat.
In FIG. 4, it is seen that, when the pressure is increased by the
injection of liquid into inflatable active seal bag 38, there is a
sufficient distension of the inflatable bag to transmit hydraulic
pressure through passive seal bag 62, and thereby effectively apply
compression to substantially all surfaces of leg 62. When the
liquid is withdrawn from seal bag 38, the environmental pressure of
the leg again tends to drop below the ambient pressure.
Illustrated in FIG. 5 is a passive seal bag 52 filled with a
non-compressible liquid. The bag is formed of a plurality of
elongated channels 66 adapted to run roughly parallel with one
another and the leg of the patient being treated. Each channel 66
has a small conduit 73 therein for use in filling the channel with
a fluid, for example, water. The walls 68 and 70 of the channels 66
are tapered outwardly from the "ankle end" to the "thigh end"
thereof in order to accomodate the normally larger diameter of the
upper leg.
It has been found that, although the face seal bags 52 are fastened
to larger casing segments 58, there is still an excessive force
exerted on the legs of the patient tending to force him towards the
head of the bed or table on which he is positioned. This force is a
consequence of the generally wedge-shaped configuration of legs
from ankle to thigh and the resultant force vector bearing upwardly
against the legs. In FIG. 5 is illustrated a seal bag comprising a
plurality of longitudinal liquid-containing compartments 66.
Thus the walls 68 of sealing bags 58, which walls bear against the
leg, tend to be restrained from movement relative to walls 70 which
are attached to casing 54. This restraint is achieved by the
tethering effect of sidewalls 72 between walls 68 and walls 70. The
tethering action markedly reduces the pushing effect on the legs of
the patient being treated.
Each compartment 66 has an independent liquid fill port 74 which is
clamped off after the compartment is filled.
FIGS. 6 and 7 illustrate a compact control module 60 which is
normally mounted integrally with the above-described leg-enclosing
members. In FIG. 6 it is seen that pressure control module 60
comprises a piston 74 which is analogous to the piston indicated at
34 in FIG. 1. Piston 74 is contained in a piston housing 76 and is
operated by means of a hydraulically activated piston 78. Piston 78
is analogous to piston 24 of FIG. 1.
Piston 74 is formed of a plastic foam core 79 which is protected on
the vacuum system side 80 with a face plate 82 and protected on the
pressure system side 84 with a face plate 86. Between each of face
plates 82 and 86 and the foam core is an elastomeric seal member
88. These seal members 88 are generally circular in shape and
extend between and are sealed by flanges 90 formed by piston
housing member 76 and lower chassis member 92 (for the lower of the
two seals) and formed by piston housing member 76 and the lower
extension 94 of accumulator housing 96 (for the upper of the two
seals).
Hydraulically activated piston 28 is supplied by drive fluid to
each face thereof through hoses 98. Piston 28 is mounted within a
vacuum accumulator tank 100 that is analogous to the accumulator 48
of FIG. 1. A check valve 102 is fastened in plate 104 which plate
forms the bottom of tank 100 and also forms the top boundary of the
cylinder 103 in which piston 74 reciprocates.
Check valve 102 provides means to avoid a backflow of gas into the
accumulator tank 100 during the upward stroke of piston 74. A
relief valve 106 is mounted in extension 94 of housing 96 to avoid
an excessive vacuum build-up in accumulator tank 100.
Moreover, an exhaust port 108 is provided in this housing extension
and provided with an exhaust valve, which valve is not shown in the
drawings but is analogous to valve 46 of FIG. 1. The vacuum line to
the leg seals is attached at port 110 in accumulator housing
96.
The pressure side 84 of piston 74 is bounded by face plate 86 and
bottom plate assembly 112. Bottom plate assembly 112 consists of a
bottom plate 115 and a dish-shaped plate 116 which effectively
avoids flexing of assembly 112 during the reciprocating action of
piston 74. A bleed valve 118 is provided for facilitating the
removal of air from the liquid in the compression zone bounded by
face plate 86 and bottom plate assembly 112.
In a particularly advantageous mode of the invention, low housing
member 114 of bottom plate assembly 112 comprises an enclosed
extension 120 which (as illustrated in FIG. 7 forms non-restricting
conduit means 121 connecting active seal bags 38 to the pressure
side 84 of piston 74. This arrangement provides excellent
mechanical bracing of the various members of the apparatus and also
minimizes any friction loss effects which would be caused by piping
the pressurizing liquid through conventional conduits.
As is best seen in FIG. 2, the compact pressure control module 60
is advantageously placed in the V-section formed by the patient's
legs. The resultant unit is compact and easily handled by hospital
personnel. Also seen in FIG. 2 are waist seal belt 123 and
foot-covering seal members 125. Belt 123 and members 125 form means
to seal the extremities of the leg casings but do so without
constricting the portion of the body at which the seal is effected.
The sealing pressure is not achieved by a tight or snug mechanical
fit but is achieved by use of the above-described vacuum system and
therefore is readily adaptable to fit most patients while limiting
the sealing pressure to less than atmospheric pressure.
It is also to be understood that the following claims are intended
to cover all of the generic and specific features of the invention
herein described and all statements of the scope of the invention
which might be said to fall therebetween.
* * * * *