U.S. patent number 3,795,242 [Application Number 05/300,291] was granted by the patent office on 1974-03-05 for apparatus for applying hydraulic pulsation.
This patent grant is currently assigned to Medical Innovations, Inc.. Invention is credited to John M. Colman, Donald C. Lerch.
United States Patent |
3,795,242 |
Lerch , et al. |
March 5, 1974 |
APPARATUS FOR APPLYING HYDRAULIC PULSATION
Abstract
An improved external pressure circulatory assist device of the
type comprising a mechanical means for transmitting a pressure
pulse to a liquid-filled blanket wrapped about a patient's legs,
the pulse being in synchronization with the heartbeat of the
patient. A novel feature of the invention is that wherein air
disturbed by the pulsing mechanism is isolated from the gas
atmosphere in the vicinity of the aforesaid blanket and is vented
to atmosphere, thereby improving the control of the pressure wave
imparted by the circulatory assist action when negative pressure is
being used in the immediate environment of the blanket.
Inventors: |
Lerch; Donald C. (Lexington,
MA), Colman; John M. (Lexington, MA) |
Assignee: |
Medical Innovations, Inc.
(Waltham, MA)
|
Family
ID: |
23158491 |
Appl.
No.: |
05/300,291 |
Filed: |
October 24, 1972 |
Current U.S.
Class: |
601/152 |
Current CPC
Class: |
A61H
9/0078 (20130101); A61H 2230/04 (20130101) |
Current International
Class: |
A61H
23/04 (20060101); A61h 007/00 () |
Field of
Search: |
;128/24R,64,40,30,302 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; Lawrence W.
Attorney, Agent or Firm: Cesari; Robert A. McKenna; John F.
Kehoe; Andrew F.
Claims
What is claimed is:
1. In an external circulatory assist apparatus of the type
comprising a reciprocating mechanical actuating means adapted to
act, in synchronous relationship to the heartbeat of a patient, on
a liquid-filled bladder confined in a rigid housing the improvement
wherein said mechanical actuating means includes a means for
mechanically isolating, and venting from said housing, gas which is
displaced by said actuating means during its reciprocal
movement.
2. Apparatus as defined in claim 1 wherein said isolation means
comprises an enclosed chamber mounted between one side of a
reciprocating platen which is acting on said liquid-filled bladder
and means to discharge gas from said chamber to outside of said
housing chamber.
3. Apparatus as defined in claim 2 wherein said chamber is formed
of a bellows extending from said platen to a frame member within
said housing.
4. Apparatus as defined in claim 3 wherein said bellows enclose
mechanical linkage means to raise and lower said platen.
5. Apparatus as defined in claim 2 wherein said chamber encloses
mechanical linkage means to raise and lower said platen.
6. Apparatus as defined in claim 5 wherein said external assist
apparatus comprises means to affect subatmospheric pressure in the
space within said housing but outside said enclosed chamber.
7. Apparatus as defined in claim 2 wherein said external assist
apparatus comprises means to affect subatmospheric pressure in the
space within said housing but outside said enclosed chamber.
8. Apparatus as defined in claim 3 wherein said external assist
apparatus comprises means to affect subatmospheric pressure in the
space within said housing but outside said enclosed chamber.
9. In a process for operating an external circulatory assist
apparatus of the type wherein a first side reciprocating mechanical
device is utilized to impart a pulsed pressure wave to limbs of a
patient which limbs are wrapped in a liquid-containing bladder
within a rigid housing, the improvement comprising the steps of
1. enclosing gas space between a second side of the reciprocating
mechanical means and said housing of the apparatus, and
2. venting gas from said space to atmospheric pressure as said
device reciprocates to alternately enlarge and decrease said
enclosed space.
10. The process of claim 9 wherein a sub-atmospheric pressure is
maintained in the environment of said bladder.
11. Apparatus as defined in claim 2 wherein said reciprocating
platen is pivotally mounted
1. near a first end of a frame within said housing, and
2. also pivotally mounted to a mechanical linkage which connects
the platen to the other end of said frame, and wherein a
linkage-actuating means is mounted at said first end of said frame
and formed means to actuate said mechanical linkage mounted at the
other end of said frame thereby forming means to distribute stress
as tensile stress applied to said frame and to minimize bending
stresses on said frame and said housing.
12. In external pressure circulatory assist apparatus of the type
comprising a reciprocating member bearing against a liquid-filled
bladder adapted to enclose a patient's legs, said bladder and
reciprocating member being enclosed in a rigid housing, the
improvement wherein said reciprocating platen is pivotally mounted
on a frame for said actuating means near a first end of said frame
and pivotally mounted to a mechanical linkage positioned near the
other end of said frame and wherein a piston-actuating cylinder is
mounted at said first end of said frame, said cylinder forming
means to actuate said mechanical linkage to actuate said
reciprocating member and thereby dissipating mechanical stresses
along the length of said frame and minimizing bending stresses
therealong.
13. Apparatus as defined in claim 12 wherein said mechanical
linkage comprises
1. a generally-triangular cam pivotally mounted to rotate in
response to the movement of a piston-actuating cylinder, and
2. a lever arm attached between said cam and said mechanical means,
said lever arm forming means to raise said mechanical actuating
means upon the rotation of said cam.
Description
BACKGROUND OF THE INVENTION
This invention relates to a novel apparatus for assisting blood
flow through the circulatory system by the use of external pressure
on a patient's body. The invention particularly relates to a means
for obtaining optimum control of the pulsing action when a negative
pressure is used adjacent the hydraulic reservoir to which the
pulsing action is transmitted.
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, thereby allowing a reduction in ventricular work
load while maintaining a satisfactory perfusion during ventricular
diastole. This general type of process is elaborated upon in an
article entitled "Synchronous Assisted Circulation," by Birtwell et
al appearing in The Canadian Medical Association Journal (vol. 95,
pages 652 to 664 on Sept. 24, 1966). In general, synchronous
external pressure assist processes are distinguishable and
advantageous over preexisting counterpulsation processes because
the latter kind of procedures involve the cannulation of a major
artery, use of an extra corporeal blood-handling device, the use of
stringent sterile techniques and the necessity of administering
anti-coagulants to the patient. Moreover, the blood trauma or
hemolysis produced by extra corporeal pumping devices limits the
permissible duration of the assist procedure and compromises the
condition of the patient. Finally, these trauma-requiring
procedures are time-consuming and can present a very significant
hazard to many patients. They increase the risk factor in treating
all patients.
In U.S. Pat. No. 3,654,919, filed by William C. Birtwell, an
improved external assist apparatus was described wherein the
effective pressure on the circulatory passages of the legs could be
cycles to valves at or below ambient pressure. This apparatus, a
major advance of the art, has been extensively used as a vehicle
for evaluating the therapeutic potential of externally assisted
circulation. At the present time, the external counterpulsation
method, e.g. as is generally described in the Birtwell application,
is the only controlled method which requires no surgical
intervention or sterile procedures, no use of anti-coagulants or
anesthesia, and produces no significant trauma. These factors are
most important because they usually allow for much earlier use of
the apparatus on the patient, in say, a state of circulatory show
than could be justified if another type of assist apparatus had to
be used.
Further advances in the development of this type of apparatus are
described in U.S. Ser. No. 197,824, filed Nov. 11, 1971 by Harold
S. Sauer et al and now U.S. Pat. No. 3,734,087. That application
disclosed a platen mounted beneath the bladder enclosing the legs
to provide a reciprocal vertical motion which controlled the
magnitude of the positive pressure on the bladder. A novel
mechanical linkage arrangement was used with the apparatus
described in that invention. That mechanical linkage helped to
minimize the input power requirements of the apparatus. This was
achieved by providing a mechanism that provided relatively large
displacement in the lower portion of the stroke where the reaction
action pressure of the bladder against the platen is relatively
low, but which at the upper portion of the stroke where the bladder
reaction pressure materially increases, provided a displacement
which was markedly reduced. In that manner, the stroke required of
the hydraulic cylinder which operated the platen, and, consequently
the power losses from pressure drop in a servo valve were held to a
minimum.
Although the mechanism described on that application has been used
successfully in a number of circumstances, it has been discovered
that when negative pressure is used during the operation of such an
external assist device, an undesirable difficulty was experienced
in the obtaining and keeping of the optimum counterpulsation
waveform.
SUMMARY OF THE INVENTION
Therefore it is the principal object of this invention to provide
an apparatus for external pressure circulatory assist which
apparatus may be operated at subatmospheric pressures with improved
control of the pulsing cycle.
Another object of the invention is to provide a circulatory assist
apparatus which has an improved mechanical pulsating means
incorporated therein.
A further object of the invention is to provide a novel means for
exerting pulsing action on the hydraulic blanket of an external
circulatory assist device.
Still another object of the invention is to provide a novel means
for operating a circulatory assist device.
It is a further object of the invention to provide a simple
mechanical pressuring means which has relatively few bearing
surfaces and has an improved life because of the incorporation
therein of rotary bearing surfaces rather than linear bearing
surfaces.
Still another object of the invention is to provide an improved
mechanical pressurizing means which is advantageously enclosed
within a rigid housing for an external circulatory assist
apparatus. The mechanical forces exerted thereby have a minimum
tendency to distort the leg unit in such a way as to either require
relatively heavy construction techniques or have an undesirable
effect on the control of the pressure pulse transmitted to the legs
of a patient.
Other objects will be apparent to those skilled in the art on their
reading of the instant application.
ILLUSTRATIVE EXAMPLE OF THE INVENTION
In this application and accompanying drawings there is shown and
described a preferred embodiment of the invention and 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 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 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 plan view of a mechanical actuating device constructed
according to the invention with the top bearing part removed
therefrom to better show the structural parts of the apparatus.
FIG. 2 is a side elevation of the apparatus shown in FIG. 1 with
the device in the upward or expanded position.
FIG. 3 is a side elevation of the apparatus shown in FIG. 2 with
the device in a contracted position.
FIG. 4 is a perspective view of a leg unit of the type in which the
mechanical actuating unit of the type shown in FIGS. 1 through 3 is
normally contained.
FIG. 5 is a section of the leg unit of FIG. 4, is somewhat
schematic, has the bellows cut away and shows the mechanical
actuating unit in place.
Referring to FIGS. 1 through 3, it is seen that a mechanical
actuating means 10 comprises a platen 12 which is pivotally mounted
at 14 on one end thereof and is connected to a mechanical linkage
system 16 at the other end thereof. This platen 12 is actuated by a
hydraulic cylinder 18 pivotally anchored at 20 to the frame 22 of
the mechanism. Cylinder 18 is also fixed by bolt 24 and yoke 26 to
operating shaft 28 of linkage system 16 at the other end thereof.
Operating shaft 28 is in turn linked to two generally triangular
cam bearings 30. Cam 30 is mounted for pivotal movement about shaft
32. And thus when the plunger 34 on hydraulic cylinder 18 exerts
force on operating shaft 28 the triangular cam is forced to rotate
in a clockwise direction about shaft 32. This causes arm 38 of cam
30 to be raised. Concurrently lever arms 39, pivotally mounted at
each side of platen 12 and to cam bearings 30, are caused to raise
platen 12. The surface of platen 12 has been partly omitted from
FIG. 1 so that one can see the means by which diaphragm or bellows
41 is attached between frame 22 and platen 12.
In FIG. 1 is seen a flange 44 to which the lower section 42 of
bellows 41 is attached. Flange 44 is the upper part of a bellows
support structure 43 which is mounted on bottom plate 46 and with
which bellows 41 forms a means to totally enclose the major portion
of the volume between bottom of plate 46 and plate 12, thereby
forming a housing for linkage system 16. A seal 47 is provided
about the aperture through which cylinder 18 passes through bellows
mount 43.
An exit path for gas expelled by the bellows is provided by vent
50.
In operation, when plunger 34 is caused to bear against operating
rod 28 and thereby to rotate triangular cams 30 in the clockwise
direction, the platen 12 rises pivoting about 14. Air is then
sucked from the atmosphere into bellows 41. Conversely, when the
platen is brought down by the retraction of the plunger, and there
is a consequent compression of the volume enclosed by bellows 41,
air is expelled through vent 50.
This arrangement has allowed an improved control to be achieved,
especially when the apparatus is operated at subatmospheric
pressure, i.e. when it is enclosed within a bag, such as shown at
57 in FIG. 5 on which a vacuum is drawn. Moreover, the linkage also
has been found to be particularly advantageous because it minimizes
stresses on the inside of housing leg housing 54 as seen in FIG.
5.
In order to fully understand the particular structural advantage of
the linkage disclosed herein, it is necessary to refer to the
apparatus disclosed in FIGS. 2 and 3 and 5. It is to be understood
that any substantial deflection by the bladder 52 of the leg unit
housing 54 must be avoided. Were housing 54 not rigid, distension
thereof would make the desirable control of the counterpulsation
cycle difficult or impossible. It is seen that the operation of the
mechanical actuating unit is ideally adapted to minimize distending
stresses on housing 54. For example, when the platen is being
forced upward by the action of hydraulic cylinder and the
mechanical linkage, forces 60 are exerted on the platen mechanism
itself and consequently on the leg unit in which the platen
mechanism is held. Using the mechanical actuating means of the
invention bottom plate 46 can be much lighter since it only has to
tolerate such tensile strength as, for example, that exerted by the
vectors 60 shown in FIG. 2. These forces cause bottom plate 46 to
be placed in tension but do not exert any significant bending
stresses thereon. Moreover, when the two sections of the leg unit
are held down by quick disconnect bolts 55 as seen in FIG. 4 and
which screw into rods 56 and 58 as seen in FIG. 2, all the vertical
forces tending to separate the top and lower segments of the leg
unit are resisted as tensile stresses in rods 56 and 58. Again
there is no moment which tends to impart a vertical bending
movement at points 64 or 66. It will be noted that the leg sections
of housing 54 are adapted to dissipate stresses therein as hoop
stresses and thereby minimize any strain from said stresses.
As a consequence of the relative lack of a bending movement and the
aforesaid distribution of forces in the structure of the invention,
the housing unit can be made of much lighter material than had been
the case with the earlier designs.
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.
* * * * *