Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
zo~
Spe~ification
Back~round of the Invention
Field of the Invention
This invention relates to medical apparatus for cleansing
internal wounds; more particularly, it relates to a self-
contained, disposable, portable, combined wound irrigator
and evacuator.
Description of the Prior Art
The evacuation of fluids from a closed wound is a
common medical practice. This is often done on completion
of surgery. Fluid evacuation usually is accomplished through
gravity drainage, pressure dressings or compression bandages
or by negative pressure or suction, the latter being preferred. I I
- Conventional closed wound suction devices include power
driven vacuum pumps, central suction systems, or-evacuated
bottles.- While each of these evacuation systems effectively
evacuates a wound, all except the evacuated bottles have--
many disadvantages because of their cost, noise and restriction
on patient mobility resulting in-the retardation of post-
operative exercises, ambulation and--rehabilitation. The
evacuated bottle may provide mobility bwt has the disadvan-
tages of cost and the necessity-of having to have many ¦
available since when one bottle fills, it must be replaced.
- The filled bottle must be emptied, sterilized and re-evacuated.
~ I .
:.,` .
..
~ 30
'~ ,'
..
~9Z0~3
In addition to evacuating fluids from a closed wound,
it is frequently necessary to expose the wound site to a flow ~-
of an irrigating solution to bathe the infected area. This
has been particularly true in the case of chronic osteo-
myelitis. In the past, wound bathing has generally been
accomplished by means of gravitational flow, such as through
an intravenous device. Irrigation in this manner further
restricts patient mobility.
The frequent necessity of bathing and evacuating a
wound site has accentuated the need for a device which will
eliminate the cumb~ersome,complicated, expensive and ~`~
restrictive combination of irrigation equipment and evacuation
equipment.
The disadvantages of the previous wound evacuation
systems have, in part, been overcome by recent inventions ;~
such as those shown in U.S. Patents Nos. 3,774,611 and
3,779,243. In both of these devices the evacuator comprises
an evacuation chamber formed with resilient side walls which
after manual compression and release, tend to return to
their original position. During return to their original
position, they provide a reduced pressure on the interior
of the container which, when connected to an internal wound
~ by means of a catheter tube, effects evacuation of the wound.
- While these inventions overcome the serious disadvantages of
- power-driven vacuum pumps and central suction systems, they
have their own disadvantages. Their major disadvantage is
the possibility of accidental compression of the container
at a time when it is undesirable. ~-
Another disadvantage includes the necessity of
:~ .
inverting the container and compressing it to empty for
re-use since this may disturb the patient. Furthermore,
these devices are deficient in that they serve only one
.
' . '
,
~.~)9;i~
purpose, namely the removal of fluids from the wound. Thus,
although these evacuation devices permit a certain amount of
patient mobility, if wound irrigation is also necessary,
the patient must be connected to a means for irrigating the
wound, such as an intravenous device. The necessity of
combining the two systems, one for evacuation and one for
irrigation, makes the entire system inconvenient, relatively
expellsive and cumbersome. While ostensibly a patient could
be ambulatory by carrying an intravenous bottle of irrigating
fluid above his head and carrying or wearing an evacuator
device, it is unlikely that such a situation would be
considered a convenient solution.
Still another disadvantage of prior art evacuatlon
devices is their wide variation of negative pressure over
the specified filling range of the devicesA When empty
and fully compressed, these devices often provide a vacuum
higher than necessary which might cause lesions if tissue
is sucked into or against the drainage tube. On the other `-
hand, as the container becomes filled with fluid, the vacuum
is reduced often to a level where the vacuum is relatively
ineffective and clots or other debris may clog the drainage
c tube. Wound evacuators presently commercially available
have total pressure variations of about 130% or more.
` U.S. Patent No. 4,058,123 provides an example of
.~ .
a device combining irrigation and evacuation that overcomes
the disadvantages of the prior art. While this patent serves
the same advantageous function, the instant invention is
significantly structurally different.
It is the disadvantages of the prior art with
respect to mobility, expense, convenience disposability,
safety and utility that the present invention is intended to
overcome.
-- 3 --
. ~'~ ' ' ' . ''~"' ' ' . ' '
.
iLQ91Z(~1~3
.
BRIEF ~ESCRIPTION OF THE INVENTION
In accordance with the invention, as embodied and
bxoadly described herein, the self-contained, combined
irrigator and evacuator comprises a container having an
irrigation port communicating with the interior of the
container, a resilient, inflatable member within the container -
having a single opening, an inlet passageway and an outlet
passageway communicating with the interior of the container,
means for inflating and filling the inflatable member with
irrigating solution, flow control means for enabling fluid
to enter the inflatable member at a higher rate than fluid
can leave the inflatable member, and means for sealingly
attaching the inflatable member opening to the irrigation
port.
By expanding against bias and filling the inflatable
member with irrigating solution, the bias or resiliency of
the inflatable member tends to expel the solution through
the irrigation port. Releasing the irrigating solution from
the inflatable member permits the inflatable member to return
to its original position, automatically providing reduced
pressure in the container exterior to the inflatable member.
The reduced pressure is conducted to the wound through the
inlet passageway of the container and aspirates fluid from
the wound.
It is preferred that the container include first and
second spaced apart opposed side walls, third and fourth -
spaced apart opposed side walls joined at the opposite ends
of the first and second side walls, the third and fourth
side walls being spaced apart a greater distance than the
first and second side walls, and a bottom wall joined to
all four side walls, the four side walls being joined together
at their tops to form the irrigation port.
_ 4 _
,.
~ - , . . : ~.
.
Preferably, the irrigator and evacuator includes a
means for selectively opening and closing the outlet passage-
way and ~he inlet passageway and means on the inlet passageway
for attaching a fluid conduit means thereto. ~ -
It is also preferred that the third and fourth side
walls of the container have a configuration which substantially
conforms to the natural, unimpeded shape of the adjacent
portion of the inflatable member when inflated, deflation of
the inflatable member effecting substantially constant
negative pressure at said inlet passageway and providing
positive irrigation pressure at the opening of the inflatable
member. The first and second walls of the container are
preferably flat in order to provide a low profile to the
container.
In the preferred embodimentr the inflatable member
is a substantially cylindrical, resilient bladder having a
single opening.
While a specific location of the inlet and the
outlet passageway in the container walls is not required, it
is preferred that the inlet passageway be in one of the third
and fourth side walls and the outlet passageway be in the
other of the third and fourth side walls, the passageways
being proximate to and on the opposite sides of the irrigation
port.
means for inflating the bladder is, preferably, a
: -:
hand-operated, resilient bulbous member mounted exterior
. . .
to the container having a neck portion defining an opening
and a second opening opposite the neck opening, theresiliency
of the bulbous member being greater than that of the bladder
and the neck of the bulbous member being mounted in fluid
flow communication with the opening in the bladder through
the irrigation port.
- 5 -
. . . .
' - . ' '
' '
. : :
- 1~92( 1(~i3
While the flow control means can be any means that
enables fluid flow into the bladder to be greater than fluid
flow out of the bladder, it is preferred that the flow control
means be two one-way check valves, each having a bleed
valve therein, one check valve being mounted on and control-
~ ling flow through the second opening of the bulbous member
; and the other check valve being mounted and controlling
flow through the neck opening.
Preferably, means for attaching fluid conduit to the
second opening of the bulbous member is provided.
: The preferred means for filling the bladder with
irrigating solution comprises a filling fluid conduit
attached at one end in fluid flow communication with the
second opening in the bulbous member and at the other end in
fluid flow communication with contained irrigating solution
at atmospheric pressure such that repetitive squeezing and
releasing of the bulbous member inflates the bladder against
its resilient bias and fills it with the irrigating solution.
It may also be preferred to include in the irrigator
and evacuator an irrigating fluid conduit and an evacuating
fluid conduit, each of the conduits being open at a first end
and having a plurality of openings at a second end, the second
ends of both fluid conduits being utilized for placement in
fluid flow communication with the fluid in the wound, the
first end of the irrigating fluid conduit being attached
to andin fluid flow communication with the second opening of
;,
the bulbous member for conducting irrigating solution
expelled from the bladder to the wound and the first end of
the evacuating fluid conduit being attached to and ln fluid
flow communication with the inlet passageway for conducting
; fluid from the wound to the container.
~ rrhe preferred embodiment also includes an inwardly
~09~ 3
extending tubular protuberance around the outlet passageway,
the protuberance extending into the container a distance
calculated to bring it in contact with the bladder at the
appropriate bladder inflation level.
The embodiments as described each meet the objective
of providing an inexpensive, reliable, disposable or re-usable,
portable, self-contained combined irrigator and evacuator.
Accordingly, the invention in one aspect provides
a self-contained, combined irrigator and evacuator for use in
bathing a wound with an irrigating liquid and removing liquid
from the wound, comprising: (a) a container having an irrigation
port communicating with the interior of the container; (b) a
resilient, inflatable member within said container having a `
single opening in fluid-flow communication with said irrigation
port; (c) an inlet passageway and an outlet passageway
communicating with the interior of said container; (d) means in
fluid-flow communication with said irrigation port for
simultaneously inflating and filling said inflatable member
against its resilient bias with said irrigating liquid; (e)
flow control means in the opening of the inflatable member for
enabling said inflating and filling means to inflate and fill ~:
said inflatable member against its bias with said irrigating `~
liquid and for restricting the rate the bias of said i~flatable
member expels irrigating liquid from said inflatable member;
(f) means for sealingly attaching said inflatable member opening
to said irrigation port; and (g) means for selectively opening
and closing said outlet passageway and said inlet passageway `
so that, as the bias of said inflatable member expels irrigating ~ `
~ liquid from said inflatable member through said irrigation port,
: 30 negative pressure created in said container due to deflation :
of said inflatable member may be used to aspirate fluid through :
said inlet passageway.
:~ 7
.~ t~'~.. ,~ ,' .
. J ~.
,
. . .
In a further aspect the invention provides a self-
contained combined irrigator and evacuator for use in bathing a
wound with an irrigated liquid and removing liquid from the wound,
comprising: (a) a substantially rigid container having sub-
stantially flat first and second spaced apart side walls, third
and fourth side walls joined to the opposite ends of and spaced
apart farther than said first and second side walls, and a bottom
wall joining all four side walls, said four side walls being
joined at their tops to.form an irrigation port communicating
with the interior of said container; (b) a substantially
cylindrical, resilient bladder having a single opening, said
bladder being within said container and said bladder opening being
in fluid flow communication with said irrigation port, said third
and fourth side walls having a configuration substantially
conforming to the natural, unimpeded shape of the adjacent portion
of said bladder when inflated; (c) an inlet passageway in one of :
. said third and fourth side walls and an outlet passageway in the
other of said third and fourth side walls, said passageways
communicating with the interior of said container and being
20 proximate to and on opposite sides of said irrigation port;
. (d) means for selectively permitting and preventing fluid flow :
through said passageways; (e) means in fluid-flow communication
with said irrigation port for simultaneously inflating and filling
said bladder against its resilient bias with said irrigating
liquid; and (f) means for preventing fluid flow between the
interior of said bladder and the interior of said container
. exterior said bladder, the former being a pressure-irrigating .
section wherein the bias of the bladder when inflated and filled
. tends to expel said irrigating liquid under positive pressure
through said irrigation port and the latter being a suction-
. evacua'cing section wherein deflation of said bladder creates a
.. negative pressure in said container which may be used to aspirate
fluid through-said inlet passageway.
- 7a -
.,, ~ . . ... . : . ,
9~3
In a further aspect the invention provides a self-
contained, combined irrigator and evacuator for use in bathing a
wound with an irrigating liquid and removing liquid from the
wound, comprising: (al a subs*antially rigid container having sub-
stantially flat first and second spaced apart side walls, third
and fourth side walls joined to the opposite ends of and spaced
apart farther than said first and second side walls, and a bottom
wall joining all four side walls, said four side walls being :
joined at their tops to form an irrigation port communicating
with the interior of said container; (b) a substantially
cylindrical, resilient bladder having a single opening, said ~:
bladder being within said container and said bladder opening
being in fluid flow communication with said irrigation port,
said third and fourth side walls having a configuration sub-
stantially conforming to the natural, unimpeded shape of the ~
: adjacent portion of said bladder when inflated; (c) an inlet .. ::
passageway in one of said third and fourth side walls and an :
outlet passageway in the other of said third and fourth side
walls, said passageways communicating with the interior of said
container and being proximate to and on opposite sides of said
irrigation port; (d) means for selectively permitting and
preventing fluid flow through said passageways; (e) a hand-
operated, resilient bulbous member exterior to said container
having a neck portion defining an opening and a second opening
opposite said neck opening, the resiliency of said bulbous member .:
being greater than that of said bladder, the neck of said
bulbous member being mounted in fluid flow communication with
said bladder opening through said irrigation port; (f) flow .
:. control means mounted on and controlling flow through said neck
` 30 opening and mounted on and controlling flow through said second
opening of said bulbous member for enabling compression of said
bulbous member for enabling compression of said bulbous member to
. inflate and fill said bladder against its bias with irrigating ..
: - 7b -
. ~. . ..
. ' . - . . ' . . .
. : : ' :
:, , . ~,, .
1~9Z~(~3
liquid at a higher rate than liquid can be expelled from said
bladder by its resilient bias; (g~ means on said second opening
of said bulbous member for permitting attachment of a fluid
conduit in fluid flow communication with said bulbous member;
(h) means on said outlet passageway for selective obturation
of said outlet passageway; and (i) means for sealingly attaching
said bladder opening to said neck opening of said bulbous member.
In a still further aspect the invention provides
a self-contained, combined irrigator and evacuator for use in
bathing a wound with an irrigating liquid and removing liquid
from the wound, comprising: (a) a resilient container having
substantially flat first and second spaced apart side walls, third
and fourth side walls joined to the opposite ends of and spaced
apart farther than the first and second side walls, and a bottom
wall joining all four side walls, the four side walls being joined
at their tops to form an irrigation port communicating with the
interior of said container; (b) a substantially cylindrical,
resilient bladder having a single opening, said bladder being
within said container and said bladder opening being in fluid flow
20 communication with said irrigation port, said third and fourth .
side walls having a configuration substantially conforming to the ~:
natural, unimpeded shape of the adjacent portions of said bladder . -
when inflated; (c) an inlet passageway in one of said third and
fourth side walls and an outlet passageway in the other of said
third and fourth side walls, said passageways communicating with
the interior of said container and being proximate to and on
opposite sides of said irrigation port; (d) means for selectively
permitting and preventing fluid flow through said passageways;
: (e) flow control means mounted on and controlling flow through
30 said irrigation port for enabling inflating and filling said
bladder against its resilient bias with said irrigating liquid
and for restricting the rate the bias of said bladder expels
, - 7c -
,
~L~9;2~3
irrigating liquid from said bladder, said flow control means
permitting squeezing and releasing the first and second side `
walls of said container creating negative pressure in said bladder
for aspirating said irrigating liquid into and filling said ~ .
bladder against said bias; (f) means on said irrigation port for
permitting attachment in fluid.flow communication of a fluid
conduit; and (g) means for sealingly attaching said bladder
opening to said irrigation port, whereby the bias of said bladder
tends to expel said irrigating liquid through said irrigation ~.
port and deflate said bladder, with said outlet passageway
obturated, creates negative pressure in said container at said in- ~ .
let passageway. .
In accordance with a method aspect of the invention
there is provided a method of concurrently irrigating and
evacuatlng a wound site through the use of a single, portable
devi.ce, comprising: (a) increasing the volume of a first chamber
against a bias while simultaneously reducing the volume of a
second chamber, said bias opposing said volume reduction; ~
(b) ~illing said first chamber with an irrigating liquid; .
(c) connecting said first chamber to said wound site by a first .
fluid conduit means; (d) connecting said second chamber to said
wound site by a second fluid conduit means; (e) permitting said ..
bias to contract said first chamber thereby expelling said
. irrigating liquid from said first chamber to said wound site
while simultaneously expanding the volume of said second chamber
. and creating a negative pressure in said second chamber; and
(f) aspirating liquid from said wound site by means of said
negative pressure created in said second chamber. ~ .
Additional objectives and advantages of the invention .. ..
will be set forth in part in the description which follows, and,
in part, will be obvious from the description, or may be learned
by practice of the invention. The objectives and advantages of
- 7d -
.: - - ,, , :' . ,:
;. ' ' ~' ' . , .' ': ' '' ' ,: ~
03
the invention may be realized and obtained by means of
instrumentalities and combinations particularly pointed out in
the appended claims.
The accompanying drawings, which are incorporated in
and constitute a part of the specification, illustrate an
embodiment of the invention and, together with the description, ~-
serve to explain the principles of the invention.
Brief Description of the Drawings
~. .
FIG. 1 is a perspective view of the combined irrigator
and evacuator formed in accordance with this invention.
FIG. 2 is a sectional view taken along line 2-2 of
FIG. 1.
FIG. 2A is a sectional view taken along line 2a-2a
of Fig. 2.
FIG. 3 is a sectional view taken along line 3-3 of
FIG.l.
FIG. 4 is an enlarged, partially cut-away perspective
view of the throat portion of the bulbous member formed in
accordance with one form of this invention.
FIG. 5 is an empirical pressure versus volume curve
of a cylindrical latex bladder within a rigid container formed
.'' '
, ''
- 7e -
, ~
.. ..... ~
Z~)3
in accordance with this invention.
FIG 6 is an enlarged sectional view of a portion of
the wall of the wound evacuator container having a roughened
interior surface.
FIG. 7 is an enlarged sectional view of a portion of
the wall of the wound evacua-tor container having a coating on
the interior surface thereof.
FIG. 8 is an enlarged, partially cut-away perspective
view of the bulbous member formed in accordance with the
embodiment of the invention.
FIG. 9 is a sectional and schematic view of an
embodiment of the irrigator and evacuator depicting a means
for filling it with irrigation fluid.
FIG. 10 is a sectional and schematic view of an
embodiment of the irrigator and evacuator depicting an
alternate means of filling it with irrigation fluid.
FIG. 11 iS a sectional view of an embodiment of the
irrigator and evacuator depicting means for storing the
irrigating solution and for filling the irrigator and evacuator
with the stored solution.
FIG. 12 is a sectional view of an embodiment of the
irrigator and evacuator depicting a means for pre-filling and
storing the irrigating solution within the irrigator and
.. ..
evacuator.
FIG. 1~ is a sectional view of an embodiment of the
irrigator and evacuator depicting another means of pre-filling
and storing irrigating solution within the irrigator and
` evacuator.
FIG. 14 iS a partial sectional view of a combined
wound irrigator and evacuator formed in accordance with
another embodiment of this invention.
- : ..... . .. . . . .
~ `
::
FIG. 15 is a top view of the wound irrigator and ~- ;
evacuator of FIG. 14.
FIG. 16 is a sectional view of the outlet port used in
a wound evacuator of FIG. 14.
: FIG. 17 is a bottom view of the outlet port of FIG.
16.
FIG. 18 is a sectional view of the inlet port used in
the wound evacuator of FI~. 14.
FIG. 19 is a sectional view taken along line 19-19 of
FIG. 18.
FIG. 20 is a bottom view of the inlet port of FIG. 18. .:
FIG. 21 is a sectional view of another embodiment of .
the invention.
. FIG. 22 is another sectional view of the embodiment
of FIG. 21.
Detailed Description of the Preferred Embodiment
Throughout the specification and claims, terms of
~ orientation, such as "front", "back", "up" and "down" are ~:
employed with respect to the orientations shown in the drawings in
: 20 order to simplify description of the invention and are not in-
~ tended to limit the location or direction of the elements with
'- respect to which these terms are used. :~
The combined irrigator and evacuator of this invention
. permits bathing of a closed wound with an irrigating solution
~` while simultaneously removing and collecting fluid from the
closed wound. This is accomplished by utilizing a resilient,;
inflatable member contained within a container. The inflatable
member is inflated and filled with the irrigating solution
and, as the irrigat.ing solution is expelled from the inflatable
member.to the wound by the ~orce of the bias of the inflatable
member, negative pressure is created in the container exterior
- to the inflatable member which, when communicated to the closed
. ~.
_ g _
,
.
20~)3
wound, aspirates fluid from the wound and collects it in the
container. -
In accordance with the invention, the combined
ixrigator and evacuator comprises a container having an irrigat-
ing port communicating with the interior of the container. As
here embodied and depicted in FIGS. 1, 2 and 3, the self-con-
tained irrigator and evacuator 10 is formed with the container
12 having opposed, spaced apart first and second side walls 16,
18 (hereinafter called "front and back walls"), opposed, spaced
apart third and fourth side walls 20, 22 adjacent and joined to `
the opposite ends of the first and second side walls 16, 18,
the third and fourth side walls 20, 22 being spaced apart a
greater distance than the first and second side walls 16, 18,
and a bottom wall 24. The four side walls 16, 18, 20 and 22
are joined together at the tops to form the irrigation port
(unnumbered).
Preferably, the container 12 is substantially rigid,
which means that it will not deform substantially when it is
` subjected to the normal forces to which devices of this sort
are expected to be exposed.
The container 12 is provided with at least one passage-
way, such as passageway 26, extending through and communicating
with the interior of the container 12. While a single inlet
passageway 26 is sufficient for operation of self-contained
irrigator and evacuator 10, it is preferred that a second
passageway 30 be provided to serve as an outlet passageway to
permit expulsion of air contained within the container 12 on
inflation of the inflatable member and to permit removal of fluid
which is received within the container 12 during utilization of
the wound irrigator and evacuator 10. Preferably, means are
provided for selectively opening and closing the outlet
passageway 30 and the inlet passageway 26. As here embodied,
" ' '
. : ' .
, - 10 -
, . .
.
~ .:
`- ~09;~003
a suitable closure or cap 32 is provided to permit the selec-
tive opening and closing of the outlet passageway 30 and a
cap 92 (FIG. 10) is provided for selective opening and closing
of the inlet passageway 26.
In accordance with the invention, a resilient, inflatable
member having a single opening is provided within the container.
As here embodied, the inflatable member is a resilient bladder
40 having an opening 42 at one end thereof. Preferably, and
as depicted in FIGS. 1, 2 and 3, third and fourth side walls -
20, 22 of the container 12 have a configuration which substan-
tially conforms to the natural unimpeded shape of the adjacent
portion of the bladder 40 when inflated, deflation of the
bladder 40 effecting substantially constant negative pressure
at the inlet passageway 26 and providing positive irrigation
pressure at the opening 42 of the bladder 40. It is also pre-
ferred that the front and back walls 16, 18 are substantially
flat, thereby giving the container 12 a low profile.
In order to provide substantially constant negative
pressure at the inlet passageway 26 throughout the entire
operating range of the wound evacuator and irrigator 10, and
to utilize substantially the entire volume of the container
` 12, the bladder 40 should have a combined actual or effective
configu:ration so that the container 12 does not physically
interfere with or distort the inflation of the bladder 40 in
at least one direction of inflation. T~rms "constant pressureH
and "substantially constant pressurel' as used throughout the
specification and claims are intended for use in a relative
sense and do not imply absolute constant or unchanging pressure.
For example, a total pressure variation of up to about 20%
to 30~ throughout about 90% of the deflation range is acceptable.
A low profile container 12 (relatively narrow from front
16 to back 18) is preferred because it can be more comfortably
' .
- 11-
~2003 : ~
and conveniently worn by a patient or attached to a support,
such as a bed or a chair. These advantages can be obtained if
the front and back walls 16, 18 are substantially flat
and relatively closely spaced apart. Substantially flat front
and back walls are walls which either are truly flat or which
have a radius of curvature much greater than the radius of the
bladder 40. Where a substantial vacuum is to be induced in the
container 12, it may be preferred to form the front and back
walls 16, 18 with a shallow outward curvature (large radius of
curvature) to provide structural strength without adversely
affecting the low profile of the container.
It is also desirable to be able to stand the container
12 vertically on a flat surface and, therefore, the bottom
wall 24 of the container preferably should be flat.
It has been found that satisfactory constant pressure
can be obtained with a cylindrical bladder when the bladder
is inflated in a low profile container ("flat" front and -
back walls). The third and fourth side walls 20, 22 adjacent
to the "flat" front and back walls 16, 18 actually or effec-
tively conform to the shape of the inflated bladder 40.
In order to actually conform the third and fourth side
walls 20,22 to the bladder shape, the third and fourth side
walls 20,22, are formed with a transverse outward curvature
~from front wall to back wall) as can be seen in Fig. 2A. ;
Preferably, the radius of transverse curvature is Wc/2 where W
` is the distance between the front and back wall 16, 18. It is
also desirable to avoid corners at the top and bottom of the side
walls and, therefore, rounded upper and lower ends are formed ;~
or, alternatively, the side walls 20, 22 can be formed with a
; 30 longitudinal curvature from top to bottom as can be seen in -
Figs. 1 and 2.
While satisfactory results can be obtained over a
- 12 -
.,: , . . . .
.,: '. ' ' ' ~.
~0~2~ 3
relatively wide range of front-to-back wall spacings, more
consistently reliable results and more usefulfilling volume
for a given container size, while maintaining relatively
constant pressure, can be obtained if the front and back walls
16, 18 are spaced apart a distance greater than twice the
diameter of the uninflated bladder (Wc ~ 2Df).
Instead of actually conforming the third and fourth
side walls 20, 22 to the inflated bladder shape, the third and
fourth side walls 20, 22 can be made to "effectively" conform
to the bladder 40 by controlling the pressure within the
container. More specifically, with the inlet passageway 26
closed as the bladder 40 is inflated, the air inside the
container 12 is expelled through the outlet passageway 30
until after the bladder contacts the third and fourth side walls
20, 22 and if it continues to inflate, it reaches a position
within the container 12 wherein the bladder 40 is about to be
; forced into a shape which is different from that it would be
if the side walls 20, 22 were non-existent. At that time,
passageway 30 is occluded by the bladder 40 to prevent further
expulsion of air from the container 12. Any further pressuriza-
tion of the bladder 40 results in a concomitent increase in
pressure inside the container 12 since the air cannot escape.
Upon release of the fluid input pressure to the bladder 40,
the pressure in the bladder 40 and in the container 12 drops
by virtue of fluid in the bladder 40 escaping through the
bladder opening 42. This concept of pressure equalization
in the container 12 and bladder 40 when the bladder 40 is about
to be deformed into a shape which adversely affects the constant
pressure curve is referred to throughout the specification
and claims as "effective" confirmation of the container shape
with the bladder shape. As used in the claims, the term
"substantially conforms" includes both "actual" and "effective"
- 13 -
:
92~10~
conformation as defined herein.
Preferably and as here embodied, the outlet passageway .
30 is occluded by the bladder 40 when it reaches a predetermined
shape. This is effected by forming the outlet passageway 30
with an inwardly extending tubular protuberance 31 which
projects into the container a distance calculated to bring
it in contact with the bladder 40 at an appropriate bladder
inflation level. The outlet passageway 30 and the protuberance
31 can be formed as an integral part of the container 12 or
can be formed as a separate member mounted in an ~ .
opening formed in the container 12. When outlet passageway
occluding concept is employed, the shape of the container 12
is not critical.
With respect to a container which actually conforms to
the bladder shape and which has a satisfactory low profile, :~
substantially constant negative pressure during deflation of
a bladder has been obtained with a container and latex cylindrical .
: bladder having the shapes generally shown in Figures 2, 2A and 3
and having the following dimension ratios.
Df = diameter of bladder; .
Lf = length of bladder = 3.0 - 4.0 Df
~c = width of container = 2.5 Df .
Rc = radius of transverse curvature of side walls
=, WC/2
..
:` D = length of container-= 1.8L
., c ~ f
c = container interior perimeter 22Df ..
The bladder thickness (Ft) together with the characteris-
.
tics of the bladder material (actually, the modulus of
elasticity) determines the vacuum level produced within the ~.
container. For a latex bladder, a bladder thickness of O.OlDf
has been found to produce a constant negative pressure in the .
above described container of approximately 30 inches of water
. - 14 -
.. , :
,~: '. ' ~. '
~09~)3 ~
(see Figure 5). The container perimeter/bladder diameter
ratio is calculated to provide not greater than a seven-fold
increase in bladder perimeter which has been found to be
within a safe stress range for a latex bladder. For a con-
venient and comfortable evacuator profile, the bulb diameter
(Db) should be approximately equal to the width of the
container (Db=Wc).
These ratios provide a self-contained wound irrigator
and evacuator having satisfactory performance by providing
relatively constant pressure in a desired pressure range
(-29 to -35 inches of water) and a safe stress for a bladder
made of natural latex. The bladder 40 can also be formed from -
any synthetic elastomer, such as polyurethane. Figure 5 is a
pressure vs. volume curve of a latex bladder having a 3/4"
uninflated diameter, a 2 1/2" free length and a 0.012" wall
thickness which was inflated in a rigid container having
dimensions substantially in accordance with the above dimension
ratios. As can be seen, the vacuum within the container remains
between 31.3 inches of water at a bladder volume of about
20 4.5 times the uninflated bladder volume (4.5 Vl) at which time
the bladder 40 first touched the relatively close container
walls (e.g. 16, 18) and 29 inches of water. The pressure
remains at this level throughout the operating range of the
irrigator and evacuator and satisfactory results have been
obtained at bladder inflations of over 30Vl. The total
pressure variation over this range was only about 8~ of the
minimum pressure within the range (29 inches of water). In
connection with wound irrigators and evacuators, the pressure
; curve of Figure 5 is considered to have a substantially con-
stant pressure.
While a specific location of the inlet passageway 26 and
the outlet passageway 30 is not required, it is preferred that
~ .
- 15 -
.
0~3
the inlet passageway 26 be in one of the third and fourth side
walls 20, 22 and the outlet passageway 30 be in the other of the
third and fourth side walls 20, 22, the passageways 26 and 30
being proximate to and on the opposite sides of the irrigation
port (unnumbered).
In accordance with the invention, means for inflating and
filling the resilient bladder 40 is provided. As here embodied,
the means for inflating and fillingthe bladder 40 is preferably
a manually operated pump, such as a hand operated resllient
bulbous member 44 having a resiliency slightly greater than the
resiliency of the bladder 40. The bulbous member 44, being
located exterior to the container 12, has a neck portion 48
defining an opening (unnumbered) and a second opening 46 opposite
the neck opening. ~he neck portion 48 of the bulbous member
44 is mounted in fluid flow communication with the opening 42
of thebladder 40 through the irrigation port (unnumbered).
In accordance with the invention, means for sealingly
attaching the bladder opening 42 to the irrigation port ~-
(unnumbered) is provided. As here embodied and depicted in
FIGS. 2 and 3, the opening 42 of the bladder 40 is mounted in
the neck portion 48 of the bulbous member 44 so that fluid
expelled from the bulbous member 44 through the neck 48 is
forced to enter the bladder 40. While the bladder 40 can be
mounted directly to the walls of the neck portion 48 of the
.. . .
bulbous member 44, the embodiment illustrated in FIGS. 2-4
employs a plug 50 which is force-fitted within the neck portion
48, the plug 50 having a fluid passageway 52 axially
therethrough. The plug is provided with an annular recess 54
to recei~e the opening 42 of the bladder 40, the open end of
the bladder 40 being trapped between the exterior of the plug
50 and the interior of the neck portion 48 of the bulbous member
44 to fixedly hold and seal the bladder 40 in place.
-16-
.
. . ' ' , .,
:. .. ; :
, .. . .
While the second opening 46 of the bulbous member 44
is shown at the top of t~e bulbous member 44, it could be
located at other convenient positions on the bulbous member 44.
Further in accordance with the invention, flow control
means are provided which enable fluid to enter the bladder 40
at a higher rate than fluid can leave the b~adder ~0. Thus,
when fluid pressure tending to enter the bladder 40 is greater
than the fluid pressure within the bladder 40, the valve means
permits free-flow of fluid into the bladder 40. However, when
fluid pressure in the bladder 40 exceeds fluid pressure exterior
the bladder opening 42, the flow control means restricts the
flow rate from the bladdsr to a predetermined minimal quantity.
As here embodied, the flow control means comprises two
one-way check valves each having a bIeed valve therein. One
check valve, such as a flapper valve 56 having a small diameter
bleed vent 58 therethrough, is mounted on the bladder side of
the plug 50. The other check valve, such as the flapper valve
57 having a small diameter bleed vent 59 therethrough, is
; mounted on the inside surface of the bulbous member 44 over the
second opening 46. When the bulbous member 44 is squeezed, the
flapper valve 56 permits the fluid in the bulbous member 44 to `~;
be freely expelled into the bladder 40 since the pressure
differential across the flapper valve 56 during such an operation
forces the flapper valve away from the plug 50 thereby permit-
- ting the fluid in the bulbous member 44 to flow easily into the
bladder 40. ~hen the bulbous member 44 is released, its resil-
ient bias tends to return it to its original shape creating a
` partial vacuum within the bulbous member 44 and the flapper
valve 57 permits fluid to flow through the second opening 46
into the bulbous member 44 since the pressure differential
across the flapper valve 57 during expansion of the bulbous
;` member forces the flapper valve 57 away from the inside surface
,.
-17-
' '. ', ,' ; ~:' ' ' ~ ' '
- : .: . .. .
", ,: - . ', . , ~ . : ', ., ,' . . : , ..
.. . . . . .
Z~3
of the bulbous member 44 permitting the fluid to flow easily
into it.
When the bladder 40 is partiAlly infl~ted and filled
with fluid and the bulbous member 44 is returning from its
squeezed or collapsed position to its normal or expanded
position, the pressure within the bladder 40 is higher than
the pressure within the bulbous 44 and the flapper valve 56 is
forced against the plug 50 thereby obturating the fluid passage-
way 52 except for the vent 58 and preventing most of the fluid
from leaving the bladder 40. Likewise, when the bulbous member
44 is squeezed, the fluid pressure inside the bulbous member
44 is greater than the fluid pressure outside the second open-
ing 46 and the flapper valve 57 is forced against the inside
surface of the bulbous member 44 thereby obturating the second
opening 46 except for the vent 59 and preventing most of the
fluid from leaving the bulbous member 44.
After the bladder 40 is fully inflated, the small b~eed
valves 58, 59 permit fluid to be expelled from the bladder 40
through the passageway 52, through the bulbous member 44 and
through the passageway 46 at a predetermined rate.
Preferably, means is provided on the second opening 46
for attaching a fluid conduit in fluid-flow communication with
the second opening 46. As here embodied, a tubular extension
45 is mounted on the bulbous member 44 over the opening 46
providing fluid flow communication with the interior of the
bulbous member 44.
As here embodied and as depicted in FIG. 9, the means
` for filling the bladder also comprises a filling fluid conduit
81 being at one end 82 attached to and in fluid flow communi-
cation with the second opening 46 of the bulbous member 44 and
at the other end 83 being in fluid flow communication with
contained irrigating solution 84 at atmospheric pressure. With
,' :
~ - -18-
.
.
.. . ..
g2~3
the outlet passageway 30 open, repetitive squeezing and releas-
ing of the bulbous member 44 inflates the bladder 40 against its
resilient bias and fills it with the irrigating solution 84.
It may be preferred to fill the bladder 40 with irri-
gating solution from a pressurized source 90 (FIG. 10). This
means of fillins the bladder 40 requires a filling fluid conduit
91 placing the second opening 46 in fluid flow communication
with the source of irrigation fluid at pressure 90. Filling
is accomplished by obturating the inlet passageway 26 either
solely by means of the check valve 80 or, in addition, adding
a cap 92. The outlet passageway 30 is open to permit expulsion
of the air from the container 12. When the bladder 40 is full,
the outlet passageway 30 is closed ~y the ~ap 32 and the filling
fluid conduit 91 is replaced by the irrigating fluid conduit
which provides fluid flow communication with the wound.
Another preferable means for filling the bladder 40 is
as depicted in FIG. 9, to join the second opening 46 in fluid
flow communication with irrigation fluid at atmospheric pressure
84 and to apply an external vacuum (not shown) to the outlet
port 30. By obturating the inlet passageway 26, as with cap 92,
and applying the vacuum to the outlet passageway 30, the
reduction in pressure in the container 12 causes expansion of
the bladder 40 and, therefore, the reduction in pressure within
. the bladder 40 aspirates irrigation fluid from the contained
irrigation fluid 84 at atmospheric pressure.
As here embodied, the inlet passageway 26 includes a
one-way check valve which precludes expulsion of air from the
. container 12 during expansion and filling of the bladder 40.
; The check valve also serves to protect against accidental
ejection of fluid through the inlet passageway 26. The one-way
check valve, such as a flapper valve 80, can be mounted on the
inlet passageway 26 for closing the inlet passageway 26 upon
pressurization of the container 12. Such accidental ejection ;
r, 1 9
;''.,' ,' ' ' '' " '' ' ~
' '' ' ~ ' . . ' ,
.
~: " ' , ' . ',
1C~9Z~C~3
of accumulated ~luids in the container may occur if the bulbous :-
member 44 is accidentally squeezed..,..Of course, the check valve
80 does not interfere with. the flow of.fluid into the container
12. Furthermore, the inlet passageway 26 can be formed such
that the bladde,r 40 occludes the port 26 when the bladder is
inflated to its intended volume to further insure against leak- '
age through passageway 26 to the patient. ` '
The preferred embodiment also includes an irrigating
fluid conduit 27 and an evacuating fluid conduit 28, each of
the conduits being open at their first ends 23, 25 and having a
plurality of openings 29 at the second end thereof for being '~
placed in fluid flow communication with fluid in the wound. The , ~.:
first end opening 23 of the irrigating fluid conduit 27 is ..
attached to and in fluid flow communication.with the second .
opening 46 of the bulbous member 44 for conducting the irrigating :' ',
solution e~pelled from the bladder 40 to the wound. The first ' -
end opening 25 of the evacuating fluid-conduit 28 is attached ~, .
,. to and in fluid flow communication with the inlet passageway
26 for conducting fluid from the wound to the container 12, thus,
.
irrigating solution contained in the expanded or inflated
bladder 40 is forced from the bladder.by the bias of the bladder
`. through thé bleed~~alve-58,-.th~ough'the.~p~ssagew~yl-5~2;,,l~throug~.the-b'ulbous
~, memberi44,-thrdugh~,the~b~eed ~lve~.. 59~,-t~oug~th~second~po,pendng646,
through the tubular extension 45 and through the irrigating
., fluid oonduit 27 to the wound. As the fluid is expelled from ;.
the bladder 40, reduction in the bladdsr volume, with the outlet
~ passageway obturated by the plug or cap 32, creates a negative
', . pressure in the container 12 which is conducted through the ,
:' inlet passageway 26 and through the evacuating fluid conduit 28
to the wound to aspirate,fluid from the wound and collect the
. fluid in the container 12.
The irrigating fluid conduit 27 and the evacuating
.' ' .
-20- :
,' .
.
~ 92~3
fluid conduit 28 are conventional fle~ible tubing that are non-
. .
toxic, non-pyrogenic, inert, non~porous and non-degradable when
used in its intended environment.
The container 12 can be ~ormed of any suitable material
such as a moldable plastic, for example, polyvinyl chloride.
The shape of the container lends itself to being blow molded;
however, it could be formed other ways, such as by injection
molding. At least a portion 39 of one of the flat side walls
16, 18 preferably is transparent and~a calibrated graduated
scale 60 is3placed along the side thereof in order to enable
volumetric measurement of the amount of fluid contained within
the container 12. The container 12 also can be provided with
mounting tabs 61 to which a belt 62 or other support means is
attached to facilitate hanging the irrigator and evacuator 10 on
a bed or chair or to ena~le the evacuator to be worn by an
ambulatory patient.
Further in accordance with the invention, it is desir-
able to provde means for preventing accidental sealing off of ; 7
a portion of the container 12 from the outlet passageway 30, ~;
especially during evacuation of fluids from the container 12
which were removed from the patient. One means for avoiding
this blockage is to provide a recess 63, as illustrated in Figs.
2 and 2A, in the interior surface of the container walls, par-
ticularly in the area leading to and adjacent to the outlet
passageway 30. Such a recess 63 assures the existence of a
fluid flow passageway from the interior of the container 12 to
the outlet passageway 30. Also, the interior surface of the
~ container walls can be roughened, such as by injection molding
"~ the container, to accomplish the same results (Figure 6). ~;
A means for minimizing bladder 40 stress is to provide
a surface coating 64 on the interior surface of the container 12,
(Figure 7) or on the exterior surface of the bladder 40, which ~
. ~:
-21-
:
, . .
,
. .. . .
~09Z~Q3
will lessen adherence of the bladder.to the interior of the
container. For example, it has been..found..that chlorinating the
surface of a latex bladder or coating,the..interior surfa~e of a
container with a conventional commercially available medical
silicone 1uid successfully lessens adherence of the bladder to
the container walls. Reduction of the adherence of the bladder
40 to the container walls also is of substantial assistance in .
maintaining the negative pressure substantially constant.
It is contemplated that the bulb member 44 can be of a
size having the same capacity as,the fully inflated bladder 40. '
In other words, a single compression of the bulbous member 44
filled with fluid would be sufficient to complete inflation and
filling of the bladder 40.
Pre'fèr~y,~the c~bi~n'~ -irri ~ an~ evacuat~p airs~l~n~lude's a ".
means for storing the irrigation solution which comprises a
transfer fluid conduit means 97 (FIG. 11) providing fluid flow
communication between the outlet passageway 30 and the second
opening 46 of the bul~ous member 44 and a one-way flow control
. . .
, means 98 located in the fluid flow path of the transfer fluid
conduit means 97 permitting fluid flow through said ~ransfer .
fluid conduit means 97 from the outlet passageway 30 to the
second opening 46 of the bulbous member 44. The irrigating
solution 99 can, therefore, be stored within the container 12
external to the bladder 40 and when the irrigator and evacuator
10 is prepared for use, the irrigating solution 99 is pumped
; from the container 12 through the outlet passageway 30, the
., transfer fluid conduit means 97, and the second opening 46 into
the bladder 40 by repetitive squeezing and releasing of the
;~ bulbous member 44. The embodiment of the irrigator and evacu-
.~ 30 ator depicted in FIG. 11 provides a means for factory preparation
. of a complete self-contained irrigator and evacuator.
'. It may also be preferred to pre-inflate and Ei~l the., .
~ -22-
., .
:, ,, ~, .
'
9Z~03
bladder 40 with irrigating solution at the.factory level. This
also provides seIf-contained irrigation and.evacuation units
without the necessity of external irrigation fluid sources~ The
potential disadvantage of the method.of storing the fluid in the
expanded bladder is the liquid loss through the bladder walls
by vapor transmission. As here embodied, this disadvantage is
overcome, as depicted in FIG. 12, by coating the inside wall of
the bladder 40 and the inside wall of the bulbous member 44
with a material that prevents or reduces the vapor transmission
loss. This material is preferably one having low vapor perme-
ability.
The coating 96 could be applied..prior to ~ladder
inflation if the coating 96 is such that it will stretch
sufficiently during bladder inflation.to ensure adequate surface
coverage after inflation. Alternatively, the coating 96 could
be applied after inflation and the bladder 40 kept inflated
thereafter through factory pre-fill operation. If, however, the
coating 96 is a non-friable material which does not significantly
; affect the bladder pressure curve and holds tenaciously to the
inside surface of the bIadder 40 during collapse, there is no
~: need to maintain the bladder inflated during post-surface treat-
ment operation. .
Another means of precluding.vapor transmission loss from :-.
; irrigation solution stored within the bladder is depicted in `
FIG. 13. In this embodiment, the irrigating solution is con-
: tained within a relatively thin and flexible film material 93 : :
having low vapor permeability of such a shape that when freely
expanded by filling the bladder 40 with the irrigating solution ... :
at atmospheric pressure, it approximately corresponds to that of
the fully expanded enclosing bladder 40 within the container 12. ~-
As can be seen in FIG. 13, the film or liner 93 is substantially .~: .
.. a bag within the bladder 40 having a single opening 94, the
.'.: . ' ' '
' '
: . . . .: - . . ,
- . : , :
- ;
. . .
9ZOQ3
opening 94 being hermetically affixed to t~e bulbous member neck
48, either mechanically or adhe`sively. In o~der to ensure maxi-
mum volume of irrigating fluid contained in the pre-filled
bladder 40, it is necessary to ensure a minimum of air trapped
between the liner 93 and the inside bladder wall.
It should be understood that the above described
measures for reducing or eliminating irrigation solution vapor
loss and direct contact of the bladder 40 and irrigation solution
may be applied with equal effectiveness to the embodiment shown
in FIG. 11 by coating or lining the outside wall of the bladder
40.
FIGS. 14 and 15 depict another embodiment of the wound
irrigator and evacuator as claimed herein. The self-contained
wound irrigator and evacuator 100 is formed with a container 10
having an inlet passageway 104 and outlet passageway 106 extend-
ing through and communicating with the interior of the container
102. The inlet and outlet passageways 104, 106 may be formed as
an integral part of the container 102 tas illustrated in FIG. 2)
; or may be formed as separate members mounted in openings formed
` 20 in the container 102 as illustrated in FIG. 14.
, An inflatable member, or example, a resilient bladder
108 within the container 102 is attached to means for inflating
; the bl~dder 108, such as the hand-operated bulbous resilient
member 110 having a neck portion 113 defining an opening and a
second opening 115 opposite the neck opening. The neck 113 is
mounted in an opening 109 through the container 102. The bulbous
member is provided with flow control means between the bulbous
member 110 and the bladder 108 and on the second opening 115, -~
each permitting free flow fluid into the bladder 108 at a higher
rate than fluid may flow from the bladder 108.
The flow control means may be any suitable imperf~ct
check valve. For example, check valves 111 and 112 having either
-24-
'' ~' '; ' ~'
- ~3920~3
a roughened surface or a roughened valve seat would permit a
limited flow rate from the blaader 108.to the bul~ous member 110
and from the bul~ous member 110 thr'ough..the second opening 115.
Another means is to provide a small bleed passageway through or
on the side of the check valve or seat.
As explained with respect to the embodiments illustrated
in FIGS. 1-8, the bladder 108 is expanded by squeezing the
bulbous member 110 and forcing fluid.into the bladder 108, the
air between the bladder 108 and the container 102 interior walls
being forced out through the outlet.passageway 106. When the
bladder 108 is fully expanded, the outlet passageway 106 is :~
closed by the plug 128 and fluid is permitted to leave the
bladder through its check valve 111 at a.controlled rate causing
a reduced pressure to exist at the inlet passageway 104 provid-
: ing the necessary suction to remove fluid.. from the,;~.patient. When
the container 102 is full, it must be emptied and the bladder
108 re-inflated and refilled, and the proc~ss repeated.
As illustrated in FIGS. 16-20, the inlet passageway 104
may be formed as a sepaxate member such as by molding. The ' -
~ 20 in~et~passage~ay~;104'also includes a check valve 120 integrally form~s-ra . -
r part thereof. The chqG~.va~vel120risiformed~by~m~1ding~al~V-shaped wall~.ori :.
disc 122.-aGross the;flu-id channel.l24.~ô~ghl~e~i~nlet~passageway:104 and~
subsequer~ly~?s~ tlng the V~-shaped wall-122 at~:its apexj,;thereby:f~Nng two
flaps.'or lids.-, Inl.~ sc,manner~ when a~-pressure~dIfferentia~ ac~oss ':`
' the check valve 120 is such that the lower pressure is in the .
container 102 as contrasted with the inlet fluid channel 124,
such as when fluid is'being removed'from the patient, the slit '~
opens and fluid is permitted to pass therethrough. However, if
pressure within the container 102 exceeds the pressure within ~ :
the inlet fluid channel 124, pressure will tend to force the
lips of the V-shaped wall 122 together, thereby closing the slit
and preventing fluid flow from the container 102 into the inlet
;: -25-
. '.
.
.: ' ' ' . . ' ' ' ' .
` ~ ~9z0~3
through channel 124 and ultimately to the patient. The check
valve 120 is recessed with respect to the mouth 119 of the inlet
passageway 104 to ensure that the bladder 108 does not interfere
with the proper operation of the check valve 120. An annular
groove 126 also is formed near the mouth 119 of the inlet passage-
way 104 to permit the inlet passageway 104 to be snap-fitted
into an aperture through the walls of the container 102.
The outlet passageway 106 can also be mol~ed as a
separate member (FIGS. 16 and 17) and a closure plug 128 can be
formed as an integral part thereof. An annular groove 130 is
formed adjacent-the mouth 115 for mounting the outlet passageway
106 on the container 102.
The inlet passageway 104 and the outlet passageway 10~
may be formed of any non-toxic, non-pyrogenic material suitable
for molding. One example of a suitable material is natural -
rubber. Natural rubber also has the proper flexibility and
resiliency to make it ideal for proper operation of the check
valve 120.
Operation of the irrigator and evacuator 10, as depicted
in FIGS. 1, 2 and 3, includes filling the bladder with irrigating
solution by any of the means mentioned above. Once the bladder
is full with irrigating solution, the outlet passageway 30 is
closed by the cap 32 and the evacuation fluid conduit 28 is
connected at its first end 25 to the inlet passageway 26 and the
openings 29 in its second end is placed in fluid flow communi-
cation with the wound. The evacuation fluid conduit 28 is
obturated by means of a common clamp 21. The first end 23 of
the irrigation fluid conduit 27 is connected in fluid flow
communication with the second opening 46 of the bulbous mem~er
44 and the openings 29 in its second end of the irrigation fluid
conduit 27 is placed in fluid flow communication with the fluid
in the wound. Unclamping the evacuating fluid conduit 28 will
-26-
.
~ g2~3
ermit the irrigating solution to flow out of the bladder ~0
and into th wound site w~ere it ~11 migrate to the openings
29 in the second end of the evacuating fluid conduit 28 along
with any wound exudate which will flow into the container.
Through the cycle of use o the irrigator and evacuator,
the quantity of exudate and irrigation solution received into
the irrigator and evacuator 10 will equal the amount of irrig-
ation solution dispensed from the bladder. Therefore, with the
wound exudating, there will of necessity accumulate a quantity
of fluid in excess of the quantity of irrigation solution placed
in the wound. This excess will have to be removed by sealing
the irrigation fluid conduit 29 closed with a common clamp,
disconnecting the irrigation fluid conduit 27 from the irrigator
and evacuator 10, emptying the container 12 and re-activating
the irrigator and evacuator 10 by pumping the bulbous member 44
to inflate the bladder 40 with air and suctioning the accumulated
excess wound fluid into the container 12 in a normal wound
suctioning manner.
me small diameter of the bleed valve holes 58 and 59 provide
a fixed, limiting value for the flow rate of the irrigation solution to the
wound site. Additional variable flow rate may be obtained by having a stop-
cock in series with the irrigation fluid conduit 27 and the bulbous m~er
44. Alternatively, the irrigation fluid 27 may be controllably pinched and
partially closed usi~g hemostats or other types of pinch clamps. Throttling
of the irrigation fluid conduit 27 is preferable to throttling the evacua-
tion fluid conduit 28 to avoid the possibility of clogging the evacuation
fluid conduit 28.
For reliable and expeditious irrigation and evacuation
as disclosed herein, the irrigator and evacuator 10 should be
operated initially by having both the irrigation and evacuation
fluid conduits 27, 28 approximately the same length and by hold-
ing the irrigator and evacuator 10 and the fluid conduits 27, 28
at approximately the same vertical elevation as the wound site
,
;
., .: ' .
- . ., , . ., , ~ ,
.,. .' ' , . ~: . , ~
until both irrigatlon and evacuat~on fluid conduits 27, 28 are
full with liquid, e.g. ~rrigation fluid filling the irrigation
fluid conduit 27 and irrigation and~or exudate fluid filling the
evacuation fluid conduit 28. After this initial step, the con-
tainer may be positioned at any vertical height, either above or
below the wound site and the suction level (negative pressure)
conducted through the evacuation fluid conduit 28 to the wound
site will remain relatively constant throughout the filling range
of the container.
The irrlgation fluid conduit 27 has no effect on the
suction value, as the effect of the height of the liquid in the
; irrigation fluid conduit 27 is cancelled or negated by the equal
height of the liquid in the evacuation fluid conduit 28. Because
of this cancellation effect of the liquid in these conduits, the
same suction value is obtained on the wound site regardless of
the height of the container either above or below the wound
site. The rate of fluid flow of the exudate and/or irrigatlon ~-~
fluid from the wound into the container must alwa~s equal the
rate of fluid flow of irrigation fluid into the wound site. ~ -
20` The irrigating solution used may be one of any number
of medicinally acceptable fluids. Examples of such irrigating
fluids are sterile, normal saline solution with or without an ~-
` antibiotic, a penicillin detergent solution, or a currently-
marketed brand of irrigating fluid such as American Cyanamid's
"Aerosol Wash."
Although the embodiment of FIGS. 1-15 utilizes the
bulbous member 44 to inflate the bladder 40, another embodiment
of the present invention allows the bladder 40 to be inflated
by deformation of the container. FIGS. 21 and 22 depict another
embodiment of the instant invention wherein the container 11 is
.. .
resilient and deformable. FIG. 21 shows the container 11 deformed
by manual squeezing of the side walls 15 and 17 and FIG. 22
depicts the bladder 40 having been inflated and filled by releas-
,',:
-28-
.
ing the side walls 15 and 17.
In this embodiment, there is no need for the bulbous
member 44. The bladder 40 is filled by placing the axial passage-
way 52 in the plug 50 in fluid flow communication with irrigat-
ing solution at atmospheric pressure as depicted in FIG. 9.
Pressing the resilient side walls 15 and 17 allows the air with-
in the container 11 to escape through the outlet passageway 30
and after closing the outlet passageway 30 releasing the resil~
ient side walls 15 and 17 creates a vacuum within the container
11 expanding the bladder 40 and aspirating the irrigating
solution through the fluid conduit means 9 to fill the bladder
40.
This embodiment depicted in FIGS. 21 and 22 is used as
previously disclosed with respect to the first embodiment.
Also it should be mentioned that the embodiment of
Figs. 21 and 22 may be used to provide filling of the bladder 40
by irrigation solution pre-stored in the container 12 as
discussed above in reference to Fig. 11. However such filling
with respect to Figs. 21 and 22 embodiment will require the use
of a tubing 97 of resilient material which can expand with each
squeezing of the container sides as the solution forced from
the container enters this tubing for temporary storage prior to
being able to flow into the bladder 40 which occurs from time
; the container 12 sides are released.
The teachings of U.S. Patent No. 4,022,209 provides
additional information wi~h respect to the details of the
resilient self-contained fluid evacuator.
While the embodiments of the invention have been
illustrated and described, it will be appreciated by those
skilled in the art and others that various changes can be made
therein without departing from the spirit or scope of the inven-
tion. Hence, the invention can be practiced otherwise than
specifically described herein.
-29-
': ' , ' :
