U.S. patent number 3,878,839 [Application Number 05/332,629] was granted by the patent office on 1975-04-22 for cardiac assist apparatus.
This patent grant is currently assigned to Hemodyne, Inc.. Invention is credited to William C. Birtwell, Robert L. Norton.
United States Patent |
3,878,839 |
Norton , et al. |
April 22, 1975 |
CARDIAC ASSIST APPARATUS
Abstract
An apparatus for providing external assistance for the
circulation of blood in a patient wherein a substantially rigid
housing encloses a portion of the patient's body, such as the legs,
and a closed pneumatic pressure actuation system is used to actuate
a pressure medium, at least a portion of which is gaseous, within
the housing to cyclically apply pressure to the body in synchronism
with the patient's heartbeat. The housing may be fabricated to
provide either a fixed volume or a variable volume therein. Means
are provided for effecting an efficient transfer of energy from the
actuation system to the pressure medium and thence to the patient's
body.
Inventors: |
Norton; Robert L. (Norfolk,
MA), Birtwell; William C. (North Scituate, RI) |
Assignee: |
Hemodyne, Inc. (Norfolk,
MA)
|
Family
ID: |
23299101 |
Appl.
No.: |
05/332,629 |
Filed: |
February 15, 1973 |
Current U.S.
Class: |
601/152 |
Current CPC
Class: |
A61H
9/0078 (20130101); A61H 31/006 (20130101); A61H
2201/1238 (20130101); A61H 2205/10 (20130101); A61H
2230/04 (20130101) |
Current International
Class: |
A61H
23/04 (20060101); A61H 31/00 (20060101); A61h
007/00 () |
Field of
Search: |
;128/64,24R,297,299,60,39,40 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; Lawrence W.
Attorney, Agent or Firm: Dike, Bronstein, Roberts, Cushman
& Pfund
Claims
What is claimed is:
1. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means having a substantially fixed
volume for enclosing a portion of said patient's body;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium, at least a portion which is in gaseous form,
enclosed in a flexible sealed member which is pressure expansible
and positioned between said pressure actuation means and said
portion of the patient's body, at least a part of said sealed
member being in contact with said body portion, a first portion of
said sealed member being formed of a flexible material sealably
clamped to the ends of said housing and a second portion thereof
being formed by said housing, said pressure medium being responsive
to said pneumatic pressure actuation means to apply pressure to
said body portion;
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat; and
means for preventing said flexible material from collapsing against
said housing during the decompression portion of the cyclical
application of said pressure.
2. An apparatus in accordance with claim 1 wherein at least
selected portions of said flexible material are tethered to
portions of said housing to prevent the tendency for relative
movement between said flexible material and said housing.
3. An apparatus in accordance with claim 2 wherein said flexible
material is tethered to said housing substantially at the ends
thereof.
4. An apparatus in accordance with claim 1 wherein said last-named
means is a perforated tubular member positioned within said housing
between said housing and said flexible material.
5. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means having a substantially fixed
volume for enclosing a portion of said patient's body;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium, at least a portion of which is in gaseous form,
enclosed in a flexible sealed member which is pressure expansible
and positioned between said pressure actuation means and said
portion of the patient's body, said sealed member being a flexible
tubular means formed independently of said housing, said sealed
member being positioned during operation of said apparatus between
the inner wall of said housing and said body portion to flexibly
enclose said body portion, said pressure medium being responsive to
said pneumatic pressure actuation means to apply pressure to said
body portion;
means for preventing the walls of said flexible sealed member from
collapsing against each other during the decompression portion of
the cyclical application of said pressure; and
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat.
6. An apparatus in accordance with claim 5 wherein portions of the
inner wall of said flexible sealed member adjacent said body
portion are tethered to portions of the outer wall thereof adjacent
said housing to prevent the tendency for relative movement of said
inner and outer walls.
7. An apparatus in accordance with claim 6 wherein said tethered
portions are substantially at the ends of said flexible sealed
member.
8. An apparatus in accordance with claim 5 wherein said said
preventing means means comprises a flexible means having a
plurality of projections extending into the interior of said sealed
member.
9. apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means having a substantially fixed
volume for enclosing a portion of said patient's body, said housing
comprising
a pair of hingedly connected portions pivotally movable relative to
each other from an open to a closed position;
means for clamping said portions together in said closed
position;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium, at least a portion of which is in gaseous form,
enclosed in a flexible sealed member which is pressure expansible,
at least a part of said sealed member being in contact with said
body portion, and positioned between said pressure actuation means
and said portion of the patient's body, said pressure medium being
responsive to said pneumatic pressure actuation means to apply
pressure to said body portion; and
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat.
10. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means having a substantially fixed
volume for enclosing a portion of said patient's body;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium enclosed in a flexible sealed member which is
pressure expansible and positioned between said pressure actuation
means and said portion of the patient's body, at least a part of
said sealed member being in contact with said body portion, said
pressure medium being a combination of a gaseous material and a
liquid material placed within said flexible sealed member in
contact with each other and further being responsive to said
pneumatic pressure actuation means to apply pressure to said body
portion; and
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat.
11. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means having a substantially fixed
volume for enclosing a portion of said patient's body;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium positioned between said pressure actuation means
and said portion of the patient's body, said pressure medium being
responsive to said pneumatic pressure actuation means to apply
pressure to said body portion;
said pressure medium being a combination of a gaseous material and
a liquid material;
said liquid material being placed within a first flexible sealed
member in contact with said body portion;
said gaseous material being placed within the said housing between
said first flexible sealed member and said housing;
said pneumatic pressure actuation means being coupled to said
gaseous material; and
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat.
12. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means having a substantially fixed
volume for enclosing a portion of said patient's body;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium positioned between said pressure actuation means
and said portion of the patient's body, said pressure medium being
responsive to said pneumatic pressure actuation means to apply
pressure to said body portion;
said pressure medium being a combination of a gaseous material and
a liquid material;
said gaseous material being placed within a flexible sealed member
in contact with and enclosing said body portion;
said liquid material being placed within said housing between said
flexible gaseous container and said housing;
said pneumatic actuation means being coupled to said liquid
material; and
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat.
13. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means for enclosing a portion of said
patient's body, said housing means including means for adjusting
the volume enclosed thereby to provide for a variable volume when
enclosing said body portion;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium, at least a portion of which is in gaseous form,
positioned between said pressure actuation means and said portion
of the patient's body, said pressure medium being responsive to
said pneumatic pressure actuation means to apply pressure to said
body portion; and means for synchronizing the operation of said
pressure actuation means to apply said pressure cyclically to
produce alternating compression and decompression of said body
portion in synchronism with said patient's heartbeat.
14. Apparatus in accordance with claim 13 wherein said pressure
medium is enclosed in a flexible sealed member which is pressure
expansible, at least a part of said sealed member being in contact
with said body portion.
15. Apparatus in accordance with claim 14 wherein a first portion
of said sealed member is formed of a flexible material sealably
clamped to the ends of said housing and a second portion thereof is
formed by said housing.
16. Apparatus in accordance with claim 14 wherein said sealed
member is a flexible tubular means formed independently of said
housing, said sealed member being positioned during operation of
said apparatus between the inner wall of said housing and said body
portion to flexibly enclose said body portion.
17. Apparatus in accordance with claim 13 wherein said pressure
medium is a combination of a gaseous material and a liquid material
placed within a flexible sealed member in contact with each
other.
18. Apparatus in accordance with claim 13 wherein said pressure
medium is a combination of a gaseous material and a liquid
material;
said liquid material being placed within a first flexible sealed
member in contact with said body portion;
said gaseous material is placed within the said housing between
said flexible sealed member and said housing; and
said pneumatic pressure actuation means is coupled to said gaseous
material.
19. Apparatus in accordance with claim 13 wherein said pressure
medium is a combination of a gaseous material and a liquid
material;
said gaseous material being contained within a flexible sealed
member in contact with and enclosing said body portion;
said liquid material being placed within said housing between said
flexible sealed member and said housing; and
said pneumatic actuation means is coupled to said liquid
material.
20. An apparatus in accordance with claim 13 wherein
said housing is formed of sheet metal being arranged in a
substantially frusto-conical shape and having overlapping portions
along the longitudinal direction thereof; and
said adjusting means providing for the adjustment of the amount of
overlap of said overlapping portions to permit adjustment of the
volume enclosed thereby.
21. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means for enclosing a portion of said
patient's body;
means for adjusting the volume enclosed by said housing means to
provide for a variable volume when enclosing said body portion;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
pressure actuation means;
a liquid pressure medium enclosed in a flexible sealed member which
is pressure expansible, said sealed member being positioned between
said pressure actuation means and said portion of the patient's
body, said pressure medium being responsive to said pressure
actuation means to apply pressure to said body portion; and
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat.
22. Apparatus in accordance with claim 21 wherein said pressure
actuation means is a hydraulic pressure actuation means coupled to
said liquid material in said flexible sealed member.
23. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means for enclosing a portion of said
patient's body;
said housing means comprising a plurality of frusto-conical
segments and further including
means for affixing a selected number of said segments to one
another to form a substantially rigid housing of a selected length
and having openings at the ends thereof of predetermined diameters
for use with body portions of different sizes;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium, at least a portion of which is in gaseous form,
positioned between said pressure actuation means and said portion
of the patient's body, said pressure medium being responsive to
said pneumatic pressure actuation means to apply pressure to said
body portion; and
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat.
24. Apparatus for providing external assistance for the circulation
of blood in a patient comprising
substantially rigid housing means for enclosing a portion of said
patient's body;
means for cyclically applying pressure to said body portion within
said housing means, said pressure applying means including
a closed pneumatic pressure actuation means;
a pressure medium, at least a portion of which is in gaseous form,
positioned between said pressure actuation means and said portion
of the patient's body, said pressure medium being responsive to
said pneumatic pressure actuation means to apply pressure to said
body portion;
means for synchronizing the operation of said pressure actuation
means to apply said pressure cyclically to produce alternating
compression and decompression of said body portion in synchronism
with said patient's heartbeat;
an evacuation chamber enclosing said housing means and the body
portion enclosed by said housing; and
vacuum pump means for maintaining a pressure within said evacuation
chamber at a level below the lowest pressure achieved during the
decompression portion of the cyclical pressure applied to said body
portion.
25. An apparatus in accordance with claim 23 wherein said one-way
valve comprises a flexible ring positioned over the ends of said
housing, the free ends of said ring being held tightly against the
body portions of said patient at said ends.
26. An apparatus in accordance with claim 25 and further including
manifold means for conveying trapped air from the interior of said
housing to said end regions thereof.
27. An apparatus in accordance with claim 24 wherein the ends of
said member include
a plurality of pockets formed therein between said layers; and
a substantially rigid stay positioned in each of said pockets;
whereby the tendency for said flexible sealed member to move
relative to said housing tends to be reduced.
28. An apparatus in accordance with claim 9 and further including
one-way valve means positioned at the common ends of said housing
and said flexible sealed member to permit the expulsion of air from
the region at said ends during the compression portion of said
cyclically applied pressure and to prevent the intake of air into
said region during the decompression portion of said cyclically
applied pressure, thereby to maintain an effective evacuation of
air in said region during said decompression portion.
29. An apparatus in accordance with claim 1 wherein said flexible
sealed member is formed of a first layer of rubberlike material and
a second layer of cloth-like material.
Description
This invention relates generally to apparatus for assisting the
circulation of blood in a human being and more particularly to an
apparatus for doing so externally by the utilization of
counter-pulsation techniques.
BACKGROUND OF THE INVENTION
Apparatus for providing external assistance in the circulation of
blood in patients has been described in previously issued articles
and patents, particularly U.S. Pat. No. 3,654,919 issued to W. C.
Birtwell wherein a rigid housing encloses a portion of the
patient's body, such as the legs, and a non-compressible hydraulic
fluid is present within such housing. A suitable hydraulically
actuated compression and decompression means is then utilized to
cycle the pressure on said body portions via the non-compressible
hydraulic fluid. Means are provided therein specifically to assure
that the environment within the rigid housing is gas free so that
no effective dead space is present and the efficiency of the
compression and decompression energy transfer is maximized.
Further, in the decompression portion of the cycle, a negative
pressure is achieved immediately adjacent the body portion and
means are provided for synchronously overriding the substmospheric
pressure which is so obtained, such overriding being in appropriate
synchronism with the patient's heartbeat.
A number of problems arise in the use of the device described in
the above Birtwell patent. First of all, it is a relatively
cumbersome structure to handle, the use of a non-compressible
hydraulic fluid, such as water, making the overall apparatus quite
heavy. Moreover, the hydraulic actuation equipment which is
required to cause the compression and decompression flow of fluid
within the housing must be placed relatively near the patient so as
to avoid excessive hydraulic pressure drops along the fluid lines
thereof, usually such actuator being placed on the table on which
the patient himself lies, often substantially centrally located
between the patient's legs, as shown in the patent.
Not only is such apparatus therein difficult to use because of the
large size and weight of the rigid housings and the hydraulic
fluid, together with the hydraulic actuation equipment therefor,
but the presence of such elaborate equipment in the direct view of
the patient may tend to produce an adverse psychological reaction
on the part of the patient when the apparatus is being applied to
the patient's limbs.
Moreover, the use of such rigid, fixed volume housing requires that
they be made sufficiently large to fit the limbs of the largest
patient to which the apparatus is expected to be applied. Thus, for
patients with relatively small limbs, substantially more hydraulic
liquid is required to fill the enclosure, a factor which only adds
to the weight of the overall device and its difficulty in use.
In considering alternative structures for providing effective
external assistance for the circulation of blood, the design
thereof should provide for a reduction in the above disadvantages
while still maintaining an effective energy transfer. The
maintenance of such energy transfer must take into account the
damping which may be present within the system, so that the effects
thereof can be minimized and the overall efficiency of the system
can be preserved.
Such damping can be broadly identified as arising from two major
sources discussed in more detail below. A first source lies in the
apparatus which comprises the system for producing the cyclic
compression and decompression energy transfer to the patient's
body. Such "system" damping can arise because of the distensibility
of the housing which is used as well as the distensibility of the
unsupported areas of the sealed portion of the system which
contains the actuating fluid at the interface between the system
and the portion of the patient's body to which the pulsating
pressure is applied. Further, the instability of the shape of such
sealed portion (i.e., the fact that such sealed portion does not
retain its shape during the pulsating cycle) also contributes to
the overall system damping. The compressibility of the actuating
medium which gives rise to the presence of dead space within the
housing also contributes to the system damping. Finally, both the
presence of trapped air at various points within the system as well
as the failure to provide an adequate contact between the sealed
interface portion of the system and the patient's body can
introduce additional damping into the system.
A second source of damping relates to the physical nature of the
patient's body itself and can be best described as a form of
"physiologic" damping. Such damping arises, for example, from the
overall motion of the patient's body which can occur during the
application of the pressure actuation system thereto. Additional
factors which contribute to such physiologic damping include the
displacement of body tissue, both in the areas to which the
pressure is directly applied and in the areas adjacent thereto, and
the compressibility of the body in those areas thereof which can
contain gas, such as the abdomen and/or the thoracic cavity.
A primary consideration in the design of the structure disclosed in
the above-mentioned Birtwell patent was the desire to reduce system
damping which can arise because of the compressibility of the
medium used to provide pressure actuation. Accordingly, such system
used non-compressible hydraulic fluids, i.e., liquids, such as
water, as the pressurizing medium in the sealed container at the
interface with the patient's body, thereby necessitating the use of
the hydraulic actuation and control system shown therein. While
some consideration was given to the reduction of damping due to one
or more of the other factors listed above (i.e., the utilization of
a rigid, fixed volume housing, longitudinal tethering of the sealed
container, etc.), little or no consideration was given to making
the most effective use of the energy available, the hydraulic
actuation system being arranged as an effectively open system where
hydraulic fluid was continually supplied from the energy source. As
a result, prime importance has been attached to the purported need
to use non-compressible fluids, as opposed to compressible fluids,
such as air, for pressure actuation and interface energy transfer
so that damping at the interface of a rigid, fixed volume housing
structure is minimized.
SUMMARY OF THE INVENTION
This invention, on the other hand, in one embodiment utilizes a
compressible fluid, either alone or in combination with a
non-compressible fluid, for energy transfer at the body interface.
The use thereof provides an improved external assist apparatus
which has the advantage of being lighter in weight and less
cumbersome to use than previously known apparatus, and further,
which can be designed to reduce considerably the possibility of
producing a traumatic experience for the patient. The effect of any
increased interface damping which may result from the use of at
least a partially compressible fluid medium is taken into account
by utilizing a more efficient actuation system designed as a
"closed" system wherein energy expended in transfer to the
patient's body is effectively stored and returned to the system for
reuse with a minimization of overall energy loss during operation.
Such efficient use of energy overcomes the effects of increased
damping due to the utilization of compressible fluids. Further, the
effects of such increased damping can be overcome in other
embodiments of the invention by utilizing housing units having
adjustable volumes, the adjustment thereof being arranged to reduce
the volume and, hence, the dead space which may give rise to
damping at the interface of the medium with the patient's body.
More specifically, in one embodiment of the invention, for example,
the housing is formed as a rigid, fixed volume type and the
pressure is applied to the patient's body portion, such as the
legs, through a medium which is at least partially in gaseous form.
Because the pressure medium is, at least partly, a gas, such as
air, the overall weight of the apparatus is reduced considerably
and the compression and decompression cycle thereof can be actuated
by the use of a pneumatic actuation system rather than a hydraulic
system as in the prior art apparatus. Such a pneumatic actuator and
control system can be placed at a position relatively remote from
and out of the view of the patient without substantial pressure
drops occurring in the pneumatic feed lines to the pressure
applying medium. The use of a pneumatic actuation apparatus, which
reduces the amount of equipment required to be located immediately
adjacent the patient, thereby lessens the traumatic experience for
the patient and provides more working space at the patient location
for the medical personnel using the apparatus. Moreover, the
reduction in weight makes the placement of the leg enclosure units
on the patient much easier than with prior art devices. The
pneumatic actuation system is designed so that some of the energy
used to effect the desired pressure at the patient's limb is stored
and reused so that the overall energy expenditure is at least
comparable to that in the prior art structures which require
hydraulic fluids for such purpose.
In still other embodiments of the apparatus of the invention
utilizing such pneumatic actuation and control together with at
least a partially gaseous pressure medium, the housing may be made
of a rigid or semi-rigid material which is arranged to permit the
formation of a variable volume of space within which the pressure
medium is enclosed. Thus, the housing is designed to be so
adjustable that a sufficiently small spatial volume can be achieved
to reduce considerably the presence of dead space which may arise
due to the compressibility of the gas. Moreover, the arrangement of
a variable volume enclosure permits the configuration of such
housings to be adjusted to patients of different sizes.
Particular embodiments of the invention are discussed in more
detail below with the help of the accompanying drawings wherein
FIG. 1 shows a pictorial view of an overall system utilizing the
apparatus of the invention;
FIG. 2 shows a view in longitudinal section of one embodiment of a
body portion housing unit used in the apparatus of FIG. 1;
FIGS. 3 and 3A show viess both in longitudinal and cross section of
another embodiment of a body portion housing unit used in the
apparatus of FIG. 1;
FIG. 4 shows a view in cross-section of the body portion housing
unit of FIG. 2 taken along the lines 4--4 thereof;
FIG. 5 shows a view in cross-section of the body portion housing
unit of FIG. 3 taken along the lines 5--5 thereof;
FIG. 6 shows a view in cross-section of a body portion housing unit
utilizing one embodiment of a pressure medium comprising a
gas-liquid combination;
FIG. 7 shows a view in cross-section of a body portion unit
utilizing another embodiment of a gas-liquid pressure medium;
FIG. 8 shows a side elevational view of a body portion housing unit
which has an adjustable configuration to permit the formation of a
variable volume within;
FIG. 9 shows a view in cross-section of the body portion housing
unit of FIG. 8 taken along the lines 9--9 thereof;
FIG. 10 shows another embodiment of a body portion housing unit
utilizing a configuration of segmented cones;
FIG. 11 shows a view in cross-section of a portion of the housing
unit shown in FIG. 10;
FIG. 12 shows a graph of one embodiment of the pressure waveform
used in the system of the invention;
FIG. 13 shows a view, partially in block form and partially in
diagrammatic form, of the pneumatic actuation system of the
invention;
FIG. 14 shows a longitudinal section view of an alternate
embodiment of the invention; and
FIGS. 15A and 15B show an alternative embodiment of the
configuration shown in FIG. 2.
As shown in FIG. 1, the overall system in accordance with the
invention comprises in one embodiment thereof a pair of leg units
in the form of housings 10 which enclose a substantial portion of
the legs of the patient to be treated. The leg units are generally
formed to permit the lower leg from approximately the ankle region
down to the foot to project outwardly from the lower end of the
housing unit, the unit extending upwardly therefrom to the upper
leg in the region of the thighs. Separate leg units may be used, or
such units may be joined at their upper ends either by fixed
connections to form a fixed angle with respect to each other or by
pivotal connections so that such angle may be suitably varied as
desired.
As described in more detail below, the leg units enclose a
pressurizeable medium which acts as an interface between the
surface of the legs of the patient within the housing and a
pressure actuation and control system 11. The medium as discussed
below can be either fully gaseous or at least partially gaseous and
is actuated by a pneumatic pressure actuation system which
cyclically feeds gas under pressure via tubings 12 to each of the
leg units and then removes said gas by reversal of said pressure to
sub-atmospheric levels in a cyclic fashion. Alternatively, the gas
may be fed by a single tubing from the actuator and then supplied
to each housing by a pair of branch tubings connected thereto by a
suitable T-connection arrangement.
Accordingly, an appropriate compression and decompression of the
patient's legs will occur so as to assist the circulation of the
blood, the cyclical application thereof being in appropriate
synchronism with the patient's heartbeat as described in the
aforementioned Birtwell patent, and as described, for example, in
the article "Support of the Systemic Circulation and Left
Ventricular Assist by Synchronous Pulsation of Extramural
Pressure," Birtwell et al., Vol. XI, Trans. Amer. Soc. Artif. Int.
Organs, 1965.
One embodiment of leg units 10 is described in more detail in FIGS.
2 and 4 wherein it can be seen that each leg unit comprises a rigid
housing 15 in a substantially frusto-conical shape, such housing in
the embodiment described being made of aluminum or an appropriate
rigid plastic material as desired. A flexible, fluid-tight material
forms a sealed member 16 which is pressure expansible the material
thereof being preferably non-distensible. The material is formed in
a tubular shape and mounted within the rigid enclosure so as to
completely enclose the major portion of the leg 17 of the patient
(not shown), the surface of the plastic material generally
conforming to the contour of the patient's leg. In the embodiment
shown the flexible material is attached to the rigid housing by
lapping the ends thereof over the rounded ends 18 of the housing so
as to permit the overlapped ends to rest in notches 19 of the
housing over which notches appropriate sealing rings 20 may be
attached. As used herein the term "flexible material" may include
thermosetting and thermoplastic elastomeric materials and may also
include, for example, multi-layered materials, such as one having a
first inner layer of distensible material and a second outer layer
of a non-distensible material, such as one having a layer of rubber
backed by a layer of cloth.
A fitting 21 is integrally formed in housing 15 to provide an
opening 22 at the exterior surface of the housing which can be
suitably connected to the pneumatic pressure actuation system 11
which supplies gas under pressure at above atmospheric pressure
throughout a first portion of its cycle and which removes gas to
create a subatmospheric pressure within the sealed member 16 during
the remaining portion of its cycle.
The pressurizeable medium is introduced into the spatial volume
between flexible sealed member 16 and the inner wall 23 of housing
15 so that as the pressure therein increases during the compression
portion of the cycle the pressure medium presses against the
patient's leg as desired. A perforated tubular member 24 is
attached by suitable means such as an adhesive to shoulders 15A at
the interior of housing 15 in the space between member 16 and
housing 15 at about a position midway therebetween. Member 24 may
be a rigid plastic material, for example, and prevents the flexible
member from collapsing completely against and adhering to the
interior wall of housing 15 during the decompression portion of the
cycle, which collapse may cause an effective but undesirable
valving action which would prevent an efficient transfer of
oscillatory energy from the actuator to the leg. Member 16 can be
made of any suitable thin metallic or plastic material, such as
aluminum or acetal, for example.
In the embodiment shown in FIGS. 3, 3A and 5, the member which
contains the pressurizeable medium is formed separately from the
rigid housing itself. As can be seen therein a flexible, tubular
sealed container 25 is made of a suitable flexible material such as
nylon-neoprene cloth, for example. In a collapsed state the
container may be folded flat or rolled up into a compact annular
shape. When the apparatus is to be used, the container 25 is
suitably unfurled and placed, as shown in FIG. 3, within the
housing over the patient's leg. The container has an appropriate
integrally-formed fitting 26 which is inserted through a suitable
opening in a rigid housing 27 and which is adapted to be connected
to a pressure actuation source. The flexible container 25 is
thereby enclosed by the rigid housing 27 which as seen in FIG. 5
can be constructed for this purpose in two pieces, 27A and 27B,
which are hingedly connected. During use, the major portion of the
patient's leg is encased in flexible container 25, is placed in
lower piece 27B and the upper piece 27A is rotated to a closed
position and clamped to the lower piece by any suitable
conventional clamping mechanism 28 to form a rigid housing around
container 25.
In order to prevent any valving action in the embodiment of FIG. 3
appropriate manifolding means may be used within the interior
thereof to prevent collapse of the outer surface thereof against
the inner surface adjacent the wall of the housing. One suitable
manifolding means as shown in FIG. 3 can comprise an interior layer
of rubber material 29 adjacent the housing wall, such layer having
a plurality of projections 29A extending toward the interior of
container 25 as shown.
In the embodiments discussed above with reference to FIGS. 1-5, as
well as in the embodiments of the prior art, a longitudinal force
difference tends to exist along the patient's legs during operation
of the system because of the difference in the cross-sectional area
at the patient's thighs and that at the patient's ankles. Such
force differential causes the inner wall of the sealed members of
the apparatus (i.e., the direct interface of the inner wall of
flexible members 16 or 25 in contact with the patient's leg in
FIGS. 2 and 3, for example) to move longitudinally with respect to
the outer wall thereof (i.e., the housing wall in FIG. 2 or the
outer wall of flexible container 25 in FIG. 3 which is in contact
with the housing). As a result, such movement tends to move the
legs and, hence, the entire body of the patient outwardly from the
housing and, in effect, to forcibly eject the patient from the
housing units, thereby reducing the effectiveness of the system to
perform its task as well as producing discomfort and a further
traumatic effect on the patient.
In order to overcome such movement it is desirable to
longitudinally tether at least a portion of the inner wall of the
sealed member to the housing (FIG. 2) or to the outer wall thereof
adjacent the housing (FIG. 3). It has been found that if such
tethering is effected, for example, along two or four parallel
lines near each end of the housing, longitudinal movement of the
inner wall of container 25 is reduced considerably. Four such
tether lines 25A are shown in an exemplary embodiment of FIGS. 3
and 3A. Although the tethered portions may extend the entire length
of the housing, it is not found necessary to do so in all
applications, and tethering at the ends thereof may be sufficient.
Accordingly, they may be arranged in preferred embodiments, for
example, to extend inwardly from each end thereof to lengths of
about 10-20 percent of the total housing length. Moreover,
additional tethered portions may be used at other positions in
addition to the ends thereof, if desired.
In the embodiment of FIGS. 2 and 24 the tethered portions 16A of
the inner wall of container 16 may be arranged to be suitably
tethered to the rounded end 18 of the housing and to the ends of
perforated member 24 as shown therein. Alternatively, in FIG. 2 the
ends of the sealed member 16 may be effectively tethered without
the necessity for adhering member 16 to the housing wall. For
example, FIGS. 15A and 15B show an alternative structure wherein
the flexible member is formed of a multi-layer material in which a
first inner layer 100 is rubber and a second outer layer 101 is
cloth. A plurality of generally longitudinally directed pockets 102
are formed between the layers at each end thereof (for simplicity
only a view of one end is shown in FIG. 15B and only a part thereof
in FIG. 15A). The extreme end of member 16 is held by the sealing
ring 20 in the manner discussed above with reference to FIG. 2 and
the pockets 102 extend from a point within the interior of the
housing to a point approximately adjacent the region where member
16 overlaps the rounded end 18 of the housing. A plurality of
spring-like, or semi-rigid, stays 103 are inserted in the plurality
of pockets at each end of flexible member 16 so as to project
inwardly of the housing. The use of such stays tends to prevent
longitudinal motion of the ends of flexible member 16 relative to
the housing 16 so that such ends are effectively tethered
thereby.
The pressurization medium in the above embodiments can be either
fully gaseous or may be a gas-liquid combination depending upon the
application which is desired. In permanent installations, for
example, where sufficient power is available for the use of
relatively large motors (e.g., over 1 horsepower), the medium can
be completely gaseous and dead space problems can be overcome by
installing a suitably sized motor to operate under all expected
dead-space conditions. Even in portable, or less permanently
installed, apparatus a completely gaseous medium can often be used
relatively effectively with smaller motors of less than 1
horsepower because of the effective utilization of energy brought
about by the use of a closed pneumatic actuation system as
discussed further below.
A further advantage of the use of pneumatic systems in this regard
is that the compressible gaseous medium can inherently achieve the
desired negative pressures with less expenditure of energy from the
energy input source than is required when using an hydraulic
medium, such as water. Thus, the use of a gaseous medium eliminates
the static head which is present when using an hydraulic medium
which completely surrounds the patient's limb. In the latter case
the positive head must be overcome before any negative pressure is
obtained. Such an advantage in using a pneumatic system then tends
further to offset any disadvantage which may arise because of any
increase in damping due to the use of a compressible gaseous
medium. This advantage can still be obtained even when using a
combined gas/liquid medium, particularly with the system discussed
below with reference to FIG. 6 where the liquid portion thereof is
maintained substantially below the patient's leg so that no static
head is present.
If the dead space which exists due to the compressibility of the
gaseous medium tends to prevent the creation of sufficient
pressures as required and if sufficiently large actuator systems
are not available to overcome such problem, such dead space may be
reduced by using an apparatus which utilizes a combined gas-liquid
pressure medium as shown with reference to FIGS. 6 and 7. As can be
seen in FIG. 6, for example, a housing 30 of the form shown in FIG.
4, for example, has a sealed flexible container 31 which
substantially conforms to the patient's leg and has contained
therein a liquid medium 32 and a gaseous medium 33 in direct
contact therewith. In a practical embodiment, for example, the
liquid medium such as water, may preferably be approximately 50
percent, or more, of the volume within the housing. A pneumatic
actuation system as shown in FIG. 1 is then appropriately connected
to fitting 34 so that the gaseous medium, such as air, can be
pressurized, the liquid medium taking up substantially most of the
dead space that may occur within the sealed enclosure due to the
compressibility of the gaseous medium. In this way, a relatively
efficient transfer of pressure to the leg can be achieved.
Another embodiment of a combined gas-liquid pressurizeable medium
is shown in FIG. 7. As can be seen therein, the liquid medium 42
and the gas medium 43 are separated from each other, the liquid
medium being placed in a flexible sealed container 41 which
encircles the leg of the patient and forms the direct pressure
interface with the patient's body. The gas coupling medium 43 is
inserted into the housing 40 between the sealed liquid container 41
and the interior surface of housing 40. An appropriate fitting 44
is connected to a pneumatic actuation system for inserting and
withdrawing gas above and below atmospheric pressure, which gas
pressure variations are coupled via gas medium 43 to the liquid
medium 42 and then to the patient's leg for providing the cyclic
compression and decompression action required.
While the use of rigid, fixed volume housing units as shown in
FIGS. 2-7 are useful in many applications, it is desirable in still
other applications to provide for rigid or semi-rigid housings
having adjustable volumes particularly for permitting an adjustment
thereof when used with patients having different limb sizes, which
adjustment can also be used to reduce any dead space which may
exist when such structure is used with a completely or partially
compressible medium. One embodiment of such a variable volume
housing is shown in FIGS. 8 and 9, the diameter of which can be
varied at varous points along the length thereof. For example, the
housing 50 may be made in the form of a collapsible, or adjustable,
sheet of metallic material, such as sheet aluminum, which is formed
in an overlapping manner into a substantially frusto-conical shape.
A plurality of adjustable bands, or rings 51 are placed at selected
positions along the length thereof. The patient's leg is inserted
into the housing when the bands are in a relatively loose condition
so that an effectively large diameter housing is formed. The bands
are then tightened so as to reduce the volume of the space between
the housing and the patient's limb in which a sealed container 52
fits. Thus, the dead space, which ordinarily may be present when a
compressible medium, such as air, is completely or partially used
as the pressurizeable medium can be minimized no matter what the
size of the patient's leg. Accordingly, the efficiency of the
overall pneumatic actuation system can be increased thereby
enhancing the capability of the system to operate even with
pressure actuation systems of relatively low power.
The variable volume structure shown can also use a completely
non-compressible medium. In such a case, because the variable
volume housing structure permits a closer conformity of the housing
to the legs of the patient, less hydraulic fluid is required than
in those fixed volume structures of the prior art so that a
consequent overall reduction in weight of the portion of the
apparatus at the patient's legs occurs. Further, the volume
adjustments permit a closer conformity of the overall sealed
container to the patient's body and tends to reduce the unsupported
annular end regions of the flexible container and, accordingly, the
damping due thereto. Further, as the housing volume is reduced, a
better conformability of the tethered portions of the sealed
container to the patient's body results.
Another embodiment of a rigid, or semi-rigid housing which can be
utilized to make the most efficient use of the apparatus of the
invention for different size patients is shown in FIG. 10. As can
be seen therein, a relatively large frusto-conically shaped housing
60 can be formed from a plurality of segmented frusto-conical
members 61 each of which can be suitably attached and detached to
adjacent of said members having corresponding diameters. In the
process of use, a selectable portion of the overall housing can be
formed in accordance with the size of the patient's leg. For
example, in the illustrated embodiment of a segmented housing of
FIG. 10, seven separable segments A-G are depicted, segments A, B,
C, E, F, G being of approximately the same length and segment D
being approximately three times larger in the specific embodiment
shown. The overall housing with all segments attached together is
made available for use with a patient. For use with a patient
having a relatively small diameter leg, sections A, B, C, D and E
may be selected and the segmented sections F and G may be detached
therefrom. For a medium sized leg, it may be desirable to utilize
only sections B, C, D, E and F with sections A and G detached
therefrom. For relatively large legs it may be desirable to use
sections C, D, E, F and G with sections A and B detached therefrom.
Accordingly, the amount of dead space which is present for use in a
system using a complete or partial gaseous medium can be minimized
by the appropriate selection of segments in accordance with the
size of a patient's leg. The segments shown in FIG. 10 can be
attached by appropriate means as shown in the exemplary embodiment
of FIG. 11. As seen therein if housing segments, each of the type
shown in FIG. 2, are used the flexible containers 62A or 62B of
adjacent segments are lapped over the corresponding ends 63A and
63B thereof to rest in notches 64A and 64B. Clamp members 65A and
65B have first flanges 66A and 66B which rest in notches 64A and
64B respectively, above the lapped ends of the flexible containers
therein. Upright flanges 67A and 67B lie adjacent each other at the
junction of the housing segments and are appropriately clamped to
each other at suitable points located on the periphery of the
housings via threaded bolts 68 inserted through threaded openings
in the upright flanges. The flanges 66A and 66B are retained in the
notched ends of the housing segments by suitable clamping bands 69A
and 69B, respectively, as shown.
In a preferred embodiment of the invention the pneumatic actuation
system which is utilized will provide an effective sinusoidal
pressure wave form 70 as shown in FIG. 12. As can be seen therein,
the pressure can vary in a particular embodiment from a minimum
valve within a preferred range of approximately +25 mm. Hg. to -50
mm. Hg., although such minimum value may be set otherwise in some
applications, to a maximum value within a preferred range of
approximately 200 mm. Hg. to 250 mm. Hg., although such maximum
value also may be set otherwise in some applications. The rise time
is defined as the time the pressure rises from a low value equal to
10 percent of the peak-to-peak value thereof to a value equal to 90
percent of such peak-to-peak value, with the fall time being
similarly defined as the time the pressure decreases from 90
percent of its peak-to-peak value to 10 percent thereof. A
preferred rise time and a preferred fall time is usually set within
a range of 80-150 milliseconds in each case.
The time duration of the pulsating portion of the wave form is
defined as the time for the pressure wave form to rise from a low
value at 10 percent of its peak-to-peak value to a time when it has
passed through its positive peak value to a value of 90 percent of
the peak-to-peak value thereof. Such time may preferably lie within
a range of about 200-500 milliseconds.
Although a sine wave is shown in FIG. 12, the system is not limited
to such a wave form. A square wave configuration may be acceptable
in some applications if the discrete changes thereof do not cause
adverse effects on the patient. Other wave shapes may be devised
also for such purpose.
A pneumatic actuation system for achieving an appropriate pressure
wave form is shown in FIG. 13 wherein it can be seen that a
suitably sized crank driven piston 75, fitted with conventional low
friction, low hysteresis seals and driven by a variable speed gear
motor 76 through an appropriate clutch/brake combination 77,
provides a means for producing synchronous pneumatic pressure
pulses of the wave shape described above, such pressure pulses
being applied to the coupling medium at the interface with the
patient's limb to create the desired hemodynamic results.
Appropriate and known means can be utilized to adjust the amplitude
of the pressure pulse and the relationship of the positive and
negative peak pressure amplitudes with ambient (room atmospheric)
pressure.
Thus, if the atmospheric pressure volume of the medium in the
pneumatic actuation system is such that the piston stroke is at its
mid-stroke position, driving the piston in one direction (forward)
will create a positive pressure and driving it in the opposite
direction (backward) will create a negative pressure. Any
appropriate combination of positive and negative peak pressures can
be arranged within the total pressure differential capability of
the pump system and can be selected for an individual patient by
adjustment of the total volume of fluid in the system (often
referred to as the "charge" on the system) to produce the optimum
hemodynamic results which are desired. Such volume adjustment can
be made by adjustment of valve 78 which supplies air from air pump
79 to the system. In a system which uses an air/liquid combination
or in a variable volume system which uses a liquid medium alone,
the hydraulic liquid can be supplied from a liquid reservoir 81 via
a suitable pump 80. Appropriate synchronism with the patient's
heartbeat can then be provided by suitable monitoring of the
patient's EKG by monitor 82, a sensing of the R wave of the
patient' s heartbeat to provide suitable control of the operation
of the clutch/brake combination 77 and, accordingly, of the piston
motion of the actuation system relative to the R wave, as shown by
the R-wave sensor and control device 83. Such synchronization and
control is explained in more detail, for example, in the article
cited above.
The effectiveness in achieving a negative pressure at the patient's
body is dependent upon how good a seal is maintained between the
inner surface of the sealed container containing the energy
coupling medium and the surface of the patient's limbs during the
negative portion of the pulsation cycle. Such seal can be
maintained by the use of an adhesive compound on the surface of the
sealed container between the container and the limb. However, such
a method may be impractical or inappropriate in many
situations.
Another method for providing such a seal is to evacuate all of the
air between the limb and the sealed container outer surface, such
evacuation being maintained against the levels of those peak
negative pressures being created by the pneumatic actuation system
applied through the actuation fluid in the sealed container. Thus,
a continuous suction can be created in the space between the limb
and the sealed container by an external evacuation device. One
method of achieving this is to enclose the legs and housing units
of the system by a vacuum enclosure 84 as shown by the dashed line
in FIG. 13, such enclosure being appropriately evacuated by an
external vacuum pump 85 which creates a zone of sub-atmospheric
pressure below that expected at the lowest region of the pressure
actuation curve of FIG. 12 around such housing system.
A further method of providing an appropriate seal is to arrange for
an effective self-evacuation system for such purpose, thereby
eliminating the need for a vacuum enclosure and external vacuum
pump. Since the sub-atmospheric pressure in the space between the
sealed container and the patient's body is required only during the
time when the pressure wave form is below atmospheric pressure,
such time being a relatively short part of the overall pressure
cycle, there need not be a requirement for a constant negative
pressure as would exist in the above described externally actuated
evacuation system. Such a self-evacuation system is shown in FIG.
14. As seen therein, the ends of the space between the sealed
container 90 and the patient's legs 91 at the ankles and at the
thighs are fitted with passive one-way valves 92 which permit the
expulsion of air from such space to the atmosphere but which
prevent the intake of air from the atmosphere to such space. Such
valves may be in the form of thin rubber rings placed over the ends
of the housing 93, the free ends thereof being held tightly against
the patient's ankles and thighs when applied. During each positive
pressure portion of the pressure wave form, the ends of the one-way
valves are opened and substantially all of the air in the space
between the leg and the sealed container is expelled therefrom.
During the negative portions of the pressure wave form the ends
thereof are closed and an effective evacuation of the space between
the limb and container is maintained. While the air is vented to
the atmosphere in the embodiment shown in FIG. 14 the output valves
may alternatively be attached to suitable suction pumps to further
insure that no air will leak back into such space during the
negative pressure phase of the pressure wave form. In order to
prevent valving of the container a suitable manifold means 94 may
be placed within the container. Such manifold means may be in the
form of a rigid tubular structure preferably extending from the
region below the knee to the end of the housing. The manifold
provides a passageway for any trapped air that may be present, such
trapped air being most likely to be present at such knee region. In
those embodiments which utilize tethers, as discussed above, the
presence of the tethers may be sufficient to provide such
passageways without the need for such an additional manifold
means.
The above description shows various embodiments of the invention,
although other embodiments within the scope of the invention may
occur to those in the art. Hence, the invention is not to be
construed as limited to the particular embodiments shown herein
except as defined by the appended claims.
The following U.S. Pat. Nos. were obtained by a patent search:
l,608,239, 2,113,253, 2,168,611, 2,345,073, 2,361,242, 3,179,106,
3,268,711, 3,288,132, 3,292,613, 3,303,841, 3,307,533, 3,329,142,
3,403,673, 3,411,496, 3,548,809, 3,599,631, 3,651,801, 3,654,919,
3,659,593, 3,674,018, 3,693,627.
* * * * *