U.S. patent number 3,875,941 [Application Number 05/457,494] was granted by the patent office on 1975-04-08 for system for evacuating fluids from the body.
This patent grant is currently assigned to Medical Dynamics, Inc.. Invention is credited to Edwin L. Adair.
United States Patent |
3,875,941 |
Adair |
April 8, 1975 |
System for evacuating fluids from the body
Abstract
An evacuation system for removing fluids from the body including
a bellows-type bottle or container made of resilient elastomeric
material for receiving the fluid connected to a body drainage
device, the bottle provided with a handle constructed to maintain
it in vertical orientation while being carried or suspended, the
bottle adapted to be vertically suspended by the handle while in
use and to expand under the weight of fluid beyond its normal
nester or rest condition to create vacuum so that fluid is forced
into the bottle under the force of initial vacuum created by the
bottle expanding to its normal rest position and thereafter by the
combined force of gravity on the fluid and the vacuum created by
further expansion of the bottle from the weight of fluid in the
container as it fills.
Inventors: |
Adair; Edwin L. (Littleton,
CO) |
Assignee: |
Medical Dynamics, Inc.
(Littleton, CO)
|
Family
ID: |
23816963 |
Appl.
No.: |
05/457,494 |
Filed: |
April 3, 1974 |
Current U.S.
Class: |
604/540; 222/213;
604/133; 141/26; 222/210; 417/472 |
Current CPC
Class: |
A61M
1/0011 (20130101); F04B 43/0054 (20130101); A61G
7/0503 (20130101); A61M 2209/082 (20130101) |
Current International
Class: |
A61G
7/05 (20060101); A61M 1/00 (20060101); A61m
001/00 () |
Field of
Search: |
;128/276,278,297
;222/210,213 ;417/472 ;141/25 ;16/110 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Bel-O-Pak," brochure of Quest, Inc..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Layton; Henry S.
Attorney, Agent or Firm: Sheridan, Ross & Fields
Claims
What I claim is:
1. A fluid evacuating system for evacuating fluids from the body
comprising in combination:
a. a flexible bellows-type container having top and bottom portions
connected by an accordian-like sidewall of resilient elastomeric
material comprised of continuous alternate ridges and valleys
adapted to fold and expand to create a vacuum upon expansion;
b. first attachment means in said top portion communicating with
the interior of said container for attaching thereto the discharge
end of a body cavity evacuating tube;
c. a body cavity evacuation tube attached by its discharge end to
said second attachment means;
d. a body fluid evacuation device connected to the intake end of
said evacuation tube;
e. second attachment means in said top portion in communication
with the interior of said container and the atmosphere;
f. a removable sealing means for said second attachment means
movably attached to said container;
g. perforate web means seated in said second attachment means
permeable to gas and impermeable to liquid to permit the passage of
gas but not liquid through said second attachment means; and
h. a rigid handle attached to said top portion for suspending said
container in a vertical orientation, said handle comprising an
upright portion, a gripping portion extending substantially
perpendicularly from the upper end of the vertical portion over
said top portion in the same plane as the upright portion; and a
locking portion attached to the distal end of the gripping portion
by a curved portion and extending in said plane toward said upright
portion substantially perpendicular to the vertical axis of said
container.
2. The system of claim 1 including drainage means in said bottom
portion for draining said container.
3. The system of claim 1 including an upwardly extending neck on
said top portion and a hollow cup attached to the top of said neck
in which said first and second attachment means are seated.
4. The system of claim 1 in which said handle is attached to said
top portion by a yoke with the ends of the yoke attached at
respective points of the top portion 180.degree. apart.
5. The system of claim 4 in which said handle is attached to said
top portion on a line passing through the vertical axis of the
container, said handle extending outwardly and upwardly in a plane
from a point substantially on said vertical axis, then forming
substantially a right angle and extending in said plane
substantially perpendicular to said vertical axis a distance to
form a gripping section, then extending in substantially a
180.degree. angle in said plane a distance to form a locking
section.
6. The system of claim 5 including a seating notch in the bottom
surface of said gripping section.
7. The system of claim 1 in which said drainage means includes a
hollow reduced diameter portion depending from said bottom portion
in communication with the interior of said container terminating in
an integral hollow peripheral rib, a boss depending from said
bottom portion near the periphery thereof, a drainage nipple in
communication with the interior of said hollow portion, a circular
insert in said drainage nipple, and a flexible drainage tube having
its intake end secured between the interior periphery of the
discharge end of said drainage nipple and the outer periphery of
said insert.
8. The system of claim 5 in which said drainage means includes a
hollow reduced diameter portion depending from said bottom portion
in communication with the interior of said container teminating in
an integral hollow peripheral rib, a boss depending from said
bottom portion near the periphery thereof, a drainage nipple in
communication with the interior of said hollow portion, a circular
insert in said drainage nipple, and a flexible drainage tube having
its intake end secured between the interior periphery of the
discharge end of said drainage nipple and the outer periphery of
said insert.
9. The system of claim 1 including valve means associated with said
evacuator tube for closing same.
10. A fluid evacuation system for evacuating fluids from a body
comprising in combination;
a. a flexible bellows-type container having top and bottom portions
connected by an accordian-like sidewall of resilient elastomeric
material comprised of continuous alternate ridges and valleys
adapted to fold and expand and to create a vacuum upon expansion,
the sidewall thickness and the elastic memory of said plastic being
such that in the normal nested or collapsed position of said
container a section of the sidewall is partially expanded and the
partially expanded section expands back to its normal position from
a compressed or folded position solely by the resiliency of the
sidewall;
b. a hollow cap attached to the top portion of said container
having first and second nipples extending outwardly from its top in
communication with the interior of said container;
c. an evacuator tube attached by its discharge end to said first
nipple;
d. a body fluid evacuation device connected to the intake end of
said evacuator tube;
e. a perforate web means seated in said second nipple permeable to
gas and impermeable to liquid to permit the passage of gas but not
liquid through said second nipple;
f. a removable sealing means for said second nipple movably
attached to said cap;
g. a rigid handle flexibly or hingedly attached to said cap for
suspending said container in a vertical orientation, said handle
comprising a yoke at its bottom end with each end of the yoke
flexibly or hingedly attached to respective portions of said cap
180.degree. apart, a main curved section attached by its bottom end
to the top of said yoke extending upwardly and curving outwardly
therefrom, a gripping section oriented substantially perpendicular
to the vertical axis of said container, a locking section
substantially parallel to said gripping section having its terminal
section extending in the direction of said main curved section, and
curved elbow sections connecting said gripping section with said
main curved section and said locking section;
h. a hollow reduced diameter portion depending from said bottom
portion in communication with the interior of said container
terminating in a integral peripheral rib;
i. a boss depending from said bottom near the periphery
thereof;
j. a drainage nipple in communication with the interior of said
hollow portion;
k. a circular insert in said drainage nipple; and
l. a flexible drainage tube having its intake end secured between
the interior periphery of the discharge end of said drainage nipple
and the outer periphery of said insert.
11. The system of claim 10 in which the distance between the
terminal end of said boss and the top of said drainage nipple is
slightly less than the diameter of said drainage tube so that said
drainage tube can be stowed by winding it around said reduced
diameter portion between said bottom portion and said peripheral
rib and locking its terminal end section between said depending
boss and said drainage nipple portion.
12. The system of claim 10 including valve means associated with
said evacuator tube for closing same.
13. The system of claim 10 in which said handle is flexibly or
hingedly connected to said cap to permit folding to facilitate
storage of said container.
14. The system of claim 13 in which said handle is connected to
said cap by a flexible plastic hinge integral with said handle.
15. The system of claim 10 including a notch in the bottom surface
of said gripping section substantially on the vertical axis of said
container.
16. A method for evacuating body fluids from the body by the
concurrent use of gravity and gravity-created vacuum
comprising:
a. establishing a drainage channel with its intake end
communicating with the interior of the body area to be drained and
its discharge end outside the body;
b. establishing communication between said discharge end and the
interior of a flexible bellows-type container sealed from the
atmosphere, and
c. vertically suspending said container by its top before or after
step (b) to allow body fluids to be evacuated into said container;
whereby said body fluids drain into said container under the
concurrent force of gravity acting on said body fluids coming from
said body and the vacuum created by expansion of said bottle under
the force of gravity acting on fluid evacuated into said
bottle.
17. The method of claim 16 in which said bellows bottle is
collapsed from its normal rest position and allowed to expand to
said normal rest position after said communication and suspension
are effected so that evacuation of said area is initiated
substantially by the vacuum created by the expansion of said
bellows bottle to its normal rest position and continued entry of
body fluids into said container expands it beyond its normal rest
position.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention lies in the field of drainage systems utilizing
vacuum bottles for draining fluids from body cavities.
2. Description of the Prior Art
Patents which relate to the use of bellows pump-type containers for
evacuating fluids from the body are as follows: U.S. Pat. Nos.
3,084,691; 3,115,138; 3,376,868; 3,421,504; 3,690,315; 3,752,158;
3,742,952; 3,774,611 and 3,779,243.
The bellows-type containers disclosed in all of these patents are
constructed for manual operation to produce vacuum, and to be
supported on a surface during operation. None of them are adapted
to be suspended during prolonged use with vacuum being created from
expansion of the bellows by the weight of fluid being discharged
therein.
Any carrying or suspending handle provided for the bellows-type
containers of these prior art patents does not rigidly support them
with the vertical axis of the device in a vertical plane. Further,
no suspension devices for the bellows-type bottles are provided for
fitting securely over the various places where such bottles are
ordinarily suspended and for satisfactory carrying by an amulatory
patient so that there is no relative movement between the handle
and the container. Accordingly, it is comparatively easy for
spillage of the contents to occur by tipping of the container or
otherwise while the bellows-type bottles of the pror art are being
carried or suspended by their suspension means.
Vacuum drainage systems are often used for draining a body cavity
wherein there is a slow accumulation of body fluids to be drained
over a long period of time. Accordingly, it is important to be able
to secure the vacuum bottle in a substantially vertical position
while in use for long periods of time. Further, it is important to
maintain the body cavity being drained under vacuum for significant
periods while body fluids are accumulating in the cavity which must
be drained. This is important because the continuous vacuum insures
that the cavity will be drained in the minimum time after
accumulation of fluid and it prevents voiding around the catheter
or other body drainage device. In addition, it is important to be
able to create vaccum in the body cavity by means other than the
normal expansion of the bellows bottle from its compressed
condition and by means other than manual operation of the bellows
bottle.
It is of further importance that the vacuum bottle be provided with
a handle which can be readily attached to bedside rails, chairs,
wheelchairs, and other hospital equipment with the bottle being
maintained in vertical orientation at all times to prevent
spillage. The handle should permit easy carrying by an ambulatory
patient with the bottle being maintained in a substantially
vertical orientation.
Accordingly, it is an object of this invention to provide a system
for evacuating fluids from the body into a bellows container for
which a handle is provided which is easily attached to hospital
equipment and carried by an ambulatory patient with practically no
relative movement between the bottle and the handle and the bottle
being supported in a substantially vertical position at all times.
A further object of the invention is a provision of a body
evacuating system utilizing a bellows-type container for removal
and storage of body fluids which can be used to create vacuum in
the body cavity over an extended period from expansion of the
bottle due to the weight of fluids being discharged therein.
SUMMARY OF THE INVENTION
The invention is a system for evacuating fluids from the body
including the combination of a body cavity drainage device such as
a catheter and a bellows-type bottle made of resilient elastomeric
material, the bellows sidewall designed to have a normal rest
position of the folds between the fullest compressed condition of
the folds and the fully expanded position of the folds so that in
use it can be compressed to its fully compressed position and
allowed to expand to its normal rest position to create vacuum to
start a drainage operation, and expanded on vertical suspension to
its fully expanded condition by the weight of fluids discharged
therein to provide further vacuum to maintain the cavity being
drained under continuous vacuum for an extended period of time. The
invention includes a rigid handle attached to the top of the bottle
to prevent relative movement between the handle and the bottle and
designed to fit over most places where such a vacuum bottle is
ordinarily hung and maintained in a substantially vertical
position, and to be easily carried by an ambulatory patient without
spillage.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevational view of the evacuating system of the
invention showing the bellows bottle in its normal rest
position;
FIG. 2 is a side elevational view in partial cross section of the
bellows bottle assembly of the system with the bellows bottle in
substantially fully expanded position;
FIG. 3 is a side elevational view partially in cross section of a
modification of the bellows bottle assembly;
FIG. 4 is a front view of the handle showing the cap to which it is
attached in partial cross section; and
FIG. 5 is a top plan view of the cap and handle assembly for the
bellows bottle.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The numeral 10 indicates the bellows-type bottle comprised of
bottom portion 12, top portion 14, and the accordian-like folds
consisting of ridges 16 and valleys 18. The construction of this
feature of the bellows bottle is well known to the art. The bottle
is made of transparent or translucent resilient elastomeric
material, such as, polyethylene or polypropylene plastic. The walls
of the bottle or container are constructed of such a thickness and
the elastic memory of the plastic is such that in its normal rest
position the bottle is only partially expanded as shown in FIG. 1.
In this particular application, the bottle in its normal rest
position is expanded only about one-third of its fully expanded
position. It will be apparent that if the bottle is suspended with
its bottom free to travel outwardly or downwardly during expansion,
sufficient weight of fluid inside the bottle will expand it to its
fully expanded position.
The top 14 of the bottle is extended to form reduced diameter neck
portion 20 provided with external threads 22. Cap 24 for the
bellows bottle is constructed with depending rim 28 provided with
internal threads 30 which mate with external threads 22 for
threaded attachment of the cap to the bottle.
The cap 24 is extended upwardly to form hollow neck 32 provided
with nipple 24 communicating with the interior of neck 32 and
adapted to receive over its exterior by press fit the discharge end
of resilient flexible evacuator tube 36. The neck 32 is also
provided with hollow nipple 38 communicating with the interior of
the neck which is for the purpose of venting the interior of the
bottle to the atmosphere. A closure member 40 for closing the air
vent off as required is secured to the neck 32 by means of a
flexible strap 41. A perforate web means 42, such as, a washer or
diaphragm, of material permeable to gas but impermeable to liquid
is positioned in the hollow of nipple 38 to prevent spillage of
liquid from the bottle if it is tilted or overturned while the
closing member 40 is off of the end of nipple 38. These perforate
materials are well known to the art, and one such material is sold
under the trade name "Zitex."
A rigid handle 44 of plastic or other suitable material is
integrally attached to cap 24. The handle assembly is made in one
molding operation as is the bellows bottle 10. The handle is
constructed with rearwardly curved portion 46 connected by curved
portion 48 with gripping section 50 which extends substantially
perpendicular to the vertical axis of the bellows bottle and across
top portion 14. The handle 44 terminates in locking section 54
extending substantially parallel to the gripping section in the
direction of rearwardly curved portion 46 and connected to the
gripping section by curved portion 52. The handle when mounted on a
structure or carried by the gripping section will maintain the
bellows bottle 10 in a substantially vertical orientation. The
parts of the handle all lie in the same plane.
The handle, and particularly the gripping and locking sections, are
constricted and oriented for easy attachment to bedside rails,
chairs, wheelchairs, and other structure from which such bottles
are ordinarily suspended, and to allow easy carrying by an
ambulatory patient. When the bottle is suspended or carried by the
handle, it is maintained in a substantially vertical orientation
with no relative movement between the handle and the bottle. The
handle is particularly advantageous in applications requiring a
protracted time interval for drainage as it can be suspended and
allowed to expand beyond its normal rest position due to the weight
of fluid entering its interior and thus create vacuum.
Flexible evacuator tube 36 is attached by connector 58 at its
intake end to a body discharge device represented in block as
indicated at 56. For closing tube 36 before removal of its intake
end from the body drainage device 56, a slide valve 59 is provided
with slot eye 60 for receiving the tube in normal open position and
a slot leg 61 for closing the tube by sliding the slot leg over it.
The body discharge device may be a urethral or a ureteral catheter,
or other body discharge device. The assembly shown is for
connection to the well known Foley catheter. Other type body
drainage devices can be used in the system, such as, a nephrostomy
tube, a cystostomy tube, a chest tube, etc. The system other than
the body drainage device is made for packaging in a sanitized
plastic container and is a disposable unit.
Reference is now made to FIGS. 3, 4 and 5 for a description of a
modification of the bellows bottle assembly of the system.
In this modification the cap 24 has been modified to eliminate the
neck 32 of the other modification and to mount nipples 62 and 64,
corresponding, respectively, to nipples 34 and 38, in the top of
cap 24.
The handle 44 has been modified to provide for mounting yoke 45 at
its bottom end constructed with yoke arms 47 which are mounted
180.degree. apart on cap 24 by means of flexible hinges 68. The
hinges 68 are of plastic and are made integral with the yoke 47.
The handle can be readily folded to facilitate packaging the unit.
The remainder of the handle is comprised of rearwardly curved
portion 46 and locking portion 54 connected to gripping portion 50
by curved elbows 48 and 52 with the handle being of one piece
construction so that it can be manufactured along with the cap in a
one-step molding procedure. A notch 66 is provided in the bottom
surface of gripping section 50 to facilitate suspension of the
bottle in a vertical orientation. The flexible hinges 68 are
foldable with sufficient force but are sufficiently rigid to
prevent relative movement between the handle and the bellows bottle
by the usual forces encountered in carrying or use of the bellows
bottle. The parts of the handle, including yoke arms 47, curved
portion 46, gripping portion 50, locking portion 54 and curved
elbows 48 and 52 all lie in the same plane.
A line connecting the ends of the arms 47 of the mounted yoke will,
of course, pass through the vertical axis of the bottle. The
central point between the arms 47 of yoke 45 as well as the notch
66 lie on the vertical axis of the container. Preferably, the
curved elbows 48 and 58 extend an equal distance from the vertical
axis of the bellows container, and most preferable, they extend
approximately to the outer periphery of the container.
The modified container is also provided with drainage means in case
the unit is made non-disposable for re-use or in case it becomes
full during one operation and must be drained to complete drainage
from the body cavity. In this modification hollow circular
depending portion 70 is made integral with the bellows container.
Depending portion 70 ends in a hollow peripheral rib 72. The
bellows bottle is also provided with depending locking boss 74 for
a purpose to be later described.
Hollow nipple 76 communicating with the interior of the bellows
bottle through hollow depending portion 70 extends integrally from
depending portion 70. This nipple has an internal peripheral flange
as shown. A circular insert 78 is used to mount the intake end of
flexible drainage tube 80 in nipple 76 by a press fit. With the
construction described the flexible drainage tube 80 can be stowed
by winding it around depending portion 70 and locking it interiorly
of depending boss 74, as the distance between the end of the boss
and the top of the nipple 76 is less than the diameter of the
tube.
In the operation of the system, the intake end of evacuator tube 36
is connected to body drainage device 56 with the bellows bottle 10
being in its normal rest position as described above. Either before
or after this connection the unit is suspended by means of handle
44 so that the bottom portion 12 is free to travel downwardly upon
expansion of bellows container 10. If routine gravity drainage is
to be used, the air vent is opened by removal of closure member 40
and drainage proceeds. Some initial vacuum can be created to start
drainage if necessary by fully compressing the bellows container 10
with closure member 40 off of the air vent followed by closing the
air vent and allowing the bellows bottle to recover to its normal
rest position.
If combined vacuum and gravity drainage is to be used, either with
or without the initial vacuum just described, the closure member 40
is left over the air vent and drainage proceeds. The forces acting
on the liquid being drained are the normal gravity force and the
vacuum created by downward expansion of the bellows bottle due to
the weight of the fluid discharged therein. This latter feature is
a decided advantage over prior art devices in that continuous
vacuum can be maintained within the cavity being drained for a
protracted period of time thus preventing voiding of the catheter
or other body drainage device as fluid accumulates in the cavity
being drained. Testing showed that when the bellows bottle
illustrated expanded to its normal rest position it drew 13 cm. of
water. On full expansion negative pressure increased by a factor of
4.
The novel gripping handle by which the bellows container is
suspended maintains the container in substantially vertical
orientation at all times during drainage into the container.
A further use of the bellows bottle is to remove material from the
evacuation tube 36 which may accumulate therein to halt the flow of
fluid. This can be done by using the bellows bottle as a pump to
disturb the material causing the stoppage so that it will be
carried along the accumulator tube.
When the bellows container is removed for disposal, the accumulator
tube 46 is closed near its intake end by means of slide valve 59
which is pushed upwardly so that slot eye 60 moves upwardly with
slot leg 61 closing the tube. The bellows container unit can then
be disposed of by sanitary procedures.
If it is desired to drain the bellows container 10 while it is
still suspended, the drainage arrangement of FIG. 3 is used. The
drainage tube 80 is, of course, provided with a slot valve (not
shown) near its discharge end like the slot valve 59, or other type
valve. This valve is, of course, closed while the unit is in use.
To drain the unit, the drainage tube 80 is merely unwound from its
stowed position around depending portion 10 and the slot valve on
its end removed to permit drainage. Upon completion of the
drainage, if the tube is to be reused, the slot valve is replaced
on drainage tube 80 and the tube stowed around depending portion 70
and locked in place as previously described. Alternatively, the
drainage tube can be disposed of and a new sanitized tube
substituted for it.
* * * * *