U.S. patent number 3,685,517 [Application Number 05/073,313] was granted by the patent office on 1972-08-22 for aseptic disposable drainage receiver.
This patent grant is currently assigned to Le Voy's Inc.. Invention is credited to Karl A. Pannier, Jr., Gordon S. Reynolds, James L. Sorenson.
United States Patent |
3,685,517 |
Reynolds , et al. |
August 22, 1972 |
ASEPTIC DISPOSABLE DRAINAGE RECEIVER
Abstract
An aseptic disposable drainage receiver for receiving drainage
from the body of a patient after wounding of or surgery performed
on the patient. The receiver includes a canister cover from which a
flexible canister liner depends, means carried by said cover for
connecting the canister and liner to a vacuum or suction system and
the liner to a tube from the patient, and means to completely seal
such connections to the liner, whereby the liner and cover as a
unit with its contents may be aseptically disposed of after a
single usage.
Inventors: |
Reynolds; Gordon S. (Salt Lake
City, UT), Pannier, Jr.; Karl A. (Salt Lake City, UT),
Sorenson; James L. (Salt Lake City, UT) |
Assignee: |
Le Voy's Inc. (Salt Lake City,
UT)
|
Family
ID: |
22113011 |
Appl.
No.: |
05/073,313 |
Filed: |
September 18, 1970 |
Current U.S.
Class: |
604/320;
141/61 |
Current CPC
Class: |
A61M
1/782 (20210501); A61M 1/604 (20210501); A61M
1/882 (20210501) |
Current International
Class: |
A61M
1/00 (20060101); A61m 001/00 () |
Field of
Search: |
;128/275,276-278
;141/59,61 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
We claim as our invention:
1. A body drainage receiving assembly including an open-top
canister, an aseptic disposable unit for receiving body exudates
comprising a cover for said canister, a canister liner depending
from said cover, and tubular fittings carried by said cover for
connecting the interior of the liner to a tube leading from the
body of a patient and to connect the interior of said canister
outside said liner and the interior of the liner in communication
with a suction system, wherein the improvements comprise
valve means in said liner to positively seal off the communication
between the interior of the liner and suction line fitting,
said valve means being of the type that once closed will remain
closed, and
a cap for disposition over the patient tube fitting to aseptically
seal the liner and its contents after use of the liner.
2. The receiving assembly of claim 1, wherein said cap is initially
engaged over the suction line fitting until the liner is put to
use, and including a cord connecting the cap to the patient tube
fitting to prevent misplacement of the cap during use of the
liner.
3. The receiving assembly of claim 2, wherein said cap has an
annular recess therein spacing a central portion away from the
outer portion, and each of said fittings having opposite internal
and external tapers to insure a tight fit with the cap.
4. The receiving assembly of claim 1, including manually operable
pull means associated with said valve means and extending through
said cover for manual closing of the valve means whenever
desired.
5. The receiving assembly of claim 4, including a flip tab secured
at one end to the outside of said cover, and
the outer end of said pull means being attached to the other end of
said flip tab.
6. The receiving assembly of claim 4, including a self-sealing plug
in said cover through which said pull means extend, and
an element to be grasped by the fingers of an operator attached to
said pull means outside of said cover.
7. The receiving assembly of claim 1, including a tubular valve
seat depending from said cover in said liner around the opening to
the suction system,
said seat decreasing internally in area toward the cover, and
said valve means comprising a resilient valve recessed to compress
and jam in said seat when closed.
8. The receiving assembly of claim 7, including
a float housing having a hollow neck secured to said valve
seat,
a hollow float in said housing having a hollow neck carrying said
valve,
said float having an opening at the top of its neck, and
the neck of said housing having an opening therein to open the
vacuum line to the interior of the liner.
9. The receiving assembly of claim 8, wherein said housing has an
opening in the bottom and an opening in the top outside the neck of
the housing to prevent any trapped air from interfering with the
free action of the float and valve carried thereby.
10. The receiving assembly of claim 1, including a float carrying
said valve means and positioned to move the same into the path of
suction in the liner upon drainage filling the liner to a
predetermined extent, whereby the valve means are forcibly closed
by the suction.
11. The receiving assembly of claim 1, wherein said cap is
initially disposed over the suction line fitting, and including a
stylet depending from the cap through the suction line fitting to a
point adjacent said valve means to prevent accidental closing of
the same during shipment and handling of the unit.
12. The receiving assembly of claim 1, including
a float having a hollow body,
a tubular neck extending upwardly from said body and carrying said
valve means, and
said neck having an opening at the top thereof so the vacua in the
float and in the liner outside the float are countervailed.
Description
RELATION APPLICATION
The invention set forth, described and claimed in the instant
application is an improvement upon the invention set forth,
described and claimed in our copending application entitled "Vacuum
Drainage Collecting Apparatus With Disposable Liner," filed Nov.
26, 1968, Ser. No. 778,963.
SUMMARY OF THE INVENTION
The instant invention or discovery relates to a drainage collecting
unit in the form of a flexible liner for disposition in a canister,
such liner being attached to the underside of a canister cover and
both the cover and liner are disposable as a unit after a single
usage. Economy of production, therefore, is a necessary factor to
warrant such disposition. The canister, of course, is repeatedly
used and may be so repeatedly used without sterilization because it
does not become contaminated.
In the past, a number of attempts have been made to provide a
disposable drainage receiver or a disposable canister liner for
receiving drainage. In one instance, a cheaper form of container in
the nature of the glass bottle with its various fittings as has
been used in hospitals for many years resulted in being too costly
to warrant its disposition and its bulk also required storage room
both before and after disposition to a material amount. In other
instances, flexible plastic canister liners were provided but in
each instance of which we are aware, those liners, including that
of our aforesaid copending application, were designed to be emptied
before disposition of the liner. Bearing in mind that the contents
of the liner drained from the body of a patient may be highly
infectious and in some instances contagious, emptying of such a
liner in a drainage sink is in many cases not desired, because
infection, contamination, or contagion may result in a location
remotely from the hospital, and in emptying such a device there is
always some little risk to the operator should he be somewhat
careless.
An object of the instant invention is to provide a liner or
receiver for infectious or contagious drainage from the body of a
patient that may be aseptically sealed prior to removal from the
canister and then the liner may safely be discarded along with its
contents.
Other features and advantages of the instant invention include the
provision of means for firmly closing the inlet port between the
liner and the tube leading to the patient's body airtightly and
pressuretightly to a more than necessary extent. A valve is also
provided to effectively close the port between the suction line and
the interior of the liner. This valve may be actuated by hand when
desired. The same valve is also automatically actuated by force
from the suction line when the liner is filled to a predetermined
extent. The valve is not designed to be reopened after once having
been closed; and means are provided to prevent accidental closing
of that valve during rough handling in transit. Further, a form of
float valve is preferably utilized and the pressure within the the
float valve body is countervailed with the pressure inside the
liner, and the latter pressure is also countervailed with the
pressure inside the canister outside the liner so that all the
vacua of these separate parts are equal.
Other objects, features and advantages of this invention will be
readily apparent from the following description of preferred
embodiments thereof, taken in conjunction with the accompanying
drawings, although variations and modifications may be effected
without departing from the spirit and scope of the novel concepts
of the disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a diagrammatic showing of the manner in which the
drainage collection unit is used in association with a patient and
a vacuum system;
FIG. 2 is an enlarged fragmentary vertical sectional view of the
disposable collection unit in association with the canister prior
to being put to use;
FIG. 3 is a reduced top plan view of the structure of FIG. 2;
FIG. 4 is a plan sectional view taken substantially as indicated by
the line IV--IV of FIG. 2, looking in the direction of the
arrow;
FIG. 5 is a fragmentary vertical sectional view of the same
structure seen in FIG. 2 but showing the same after usage in sealed
aseptic condition;
FIG. 6 is a fragmentary vertical sectional view of a modified form
of the structure, showing the same prior to use; and
FIG. 7 is a fragmentary vertical sectional view showing the
structure of FIG. 6 after usage.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Both illustrated embodiments of the instant invention are utilized
with a canister 1 which may be made of relatively rigid plastic
material and which is open at the top, and closed at the bottom as
indicated at 2. This canister is designed for long and repeated
usage and may be repeatedly used without sterilization since it
does not receive any drainage from the patient's body.
The first illustrated embodiment of this invention is shown in
detail in FIGS.2, 3, 4 and 5 of the drawings, and comprises a
canister cover 3 from which a flexible thermoplastic liner depends.
The liner is closed at the bottom, and the upper open end of the
liner may be folded over as indicated at 5 or otherwise folded and
is fused or equivalently secured to the inside of the cover in a
completely airtight and positive manner. The cover is preferably a
rigid plastic material compatible with that from which the liner or
receiver 4 is formed. The cover is provided with a fitting 6
defining a port of entry into the liner for drainage from the body
of a patient, and also with a fitting 7 for connection to a suction
line or source of vacuum.
Referring now to FIG. 1, the canister 1 may be supported on any
suitable stand 8 or otherwise held in a convenient position
adjacent a bed 9 upon which a patient 10 lies. The fitting 6 of the
canister cover 3 is connected by way of a tube 11 to the body of a
patient, while the fitting 7 is connected by way of a tube 12 to a
suitable source of suction 13. In the illustrated instance, the
tube 11 enters the thoracic cavity of the patient which would be
indicated by a chest wound, breast removal, lung surgery, and other
chest injuries or operations. When suction is applied through the
tube 12,it will draw drainage from the patient through the tube 11
into the liner 4, such drainage being blood, pus, excess liquid,
and various exudates, and such drainage is frequently highly
infectious and sometimes contagious. The structure by which such
drainage will be confined entirely to the inside of the liner 4
will now be described.
The canister cover 3 may satisfactorily have a skirt 14 with a bead
15 or other formation on the inside thereof so that it can be
snapped on to the canister in an airtight manner. A tab 16 integral
with the skirt may be added to facilitate removal of the cover.
Also, a bail (not shown) may be connected to the cover in any
suitable or known manner.
With reference more particularly to FIG. 2, it will be noted that
the fitting 7 has an enlarged base 17 thereon which is attached to
the cover 3, and that base is provided in its underside with an
enlarged opening 18 which communicates with the passage through the
fitting 7 and also overlies a pair of spaced apertures 19 and 20
through the cover 3. It will be noted that the liner 4 is deviated
in the region of the base 17 and secured tightly to the solid
portion of the cover 3 between the two apertures as indicated at 21
so that the aperture or port 19 communicates with the interior of
the canister outside the liner, while the port 20 communicates only
with the inside of the liner. Thus, the vacuum acts both inside the
canister but outside the liner and inside the liner so that the
vacua therein are equalized or countervailed. If the vacuum were
only applied to the inside of the canister but outside the liner,
the liner would expand but there would be no constant and proper
suction to draw drainage from the body of the patient. On the other
hand, if vacuum were only applied to the inside of the liner alone,
the liner would tend to collapse and not expand properly owing to
the air pressure within the canister itself. Consequently, for a
desirably satisfactory performance the vacua should be equalized,
in which event there is constant and proper suction from the body
of the patient, and the liner remains in fully expanded
position.
Beneath the port 20 to the liner are closure means to seal off the
port 20. In the illustrated instance the closure means are in the
form of a valve assembly generally indicated by numeral 22. This
valve assembly includes a tubular valve seat depending from the
inner side of the cover 3 and having a tapering bore 24
therethrough which gradually decreases in size toward the cover and
the opening 20 therein. A float housing 25 is provided which is
affixed to the hollow valve seat 23 by means of a neck portion 26
of reduced diameter secured at its upper end to the valve seat. The
neck of the float housing is provided with diametrally opposed
slots 27--27 to establish communication between the interior of the
liner and the suction port 20. It will be noted also that the float
housing 25 has a bottom opening 28 therein. Inside the housing 25
is a hollow float 29 having an upstanding hollow neck 30 in which
the hollow stem 31 of a hollow-head valve 32 is inserted. The valve
and stem are made of a resilient and compressible material such as
rubber or synthetic rubber. The housing 25 acts as a guide for the
float 29 and the stem 26 of the housing acts as a guide for the
valve itself. The float, of course, will rise within the housing 25
provided the drainage in the container reaches a level for it to
enter through the opening 28 and buoy up the float. In order to
prevent any hinderance of the movement of the float by virtue of a
quantity of air being entrapped in the upper end of the housing 25,
the top of the housing is provided with diametrally opposed
apertures 34--34.
The construction just above described has a distinct and definite
advantage in that the valve and its stem being hollow and having a
passage therethrough eliminates any pressure differential between
the interior of the float and inside the liner 4, the pressure
inside the float being countervailed or equalized with the pressure
inside the liner. Thus, there can be no injury to or explosion of
the float regardless of the liquid depth in the liner and
regardless of any sudden variation in the amount of vacuum in the
liner.
The valve assembly 22, with the exception of the valve itself, is
preferably fabricated from pieces of thermoplastic material and the
parts are fused, welded, or equivalently secured together, as are
the various other parts of the structure of the disposable
unit.
While the valve is automatically closed when the drainage within
the liner 4 reaches a predetermined level and raises the float 29,
it is also important that the valve can be manually closed in case
it is desired to remove and discard the disposable unit before the
drainage reaches a sufficient level to close the valve. To this
end, means are provided to manually close the valve whenever
desired. While means embodying mechanical linkages of various types
might be utilized for this purpose, it will be noted that the
entire valve assembly is disposed at an angle to the side wall of
the canister of approximately 5.degree. to accommodate flexing of
the cover 3 under extreme vacuum in the liner and canister. Should
the cover so flex, such a mechanical linkage may not remain
positive in its operation. With that in mind, we have provided
simple means for manually actuating the valve. These means comprise
a thin pull cord 35, which may satisfactorily be a fine nylon
thread which possesses more than ample strength for the purpose.
This thread is secured at one end to a cross bar 36 within the body
of the float 29, and the cord extends upwardly through the valve
and the port 20 and turns laterally beneath the base 17 of the
fitting 7, and the other end of the cord is tied around the free
end of a flip-tab 37, FIG. 3, which is secured to the external face
of the cover only at the opposite end portion 38 to one side of a
line of weakness 39. THe flip-tab may be easily actuated by the
fingers of an operator and bent through 180.degree. along the line
of weakness or broken off at that line, and the movement of the
flip-tab through 180.degree. is normally sufficient to forcibly
close the valve, although in most instances an extra pull on the
cord for insurance will be made.
Once the valve is closed and in the position seen in FIG. 5, firmly
seated in the valve seat 23, it cannot be reopened. Therefore,
means are provided to prevent the valve becoming accidentally
closed such as by inverting the disposable unit prior to usage,
rough handling during shipment of the units, or otherwise. To this
end, a cap 40, fluted as indicated at 41 to establish a firm grip
thereon, is disposed over the fitting 7. This cap has an annular
recess 42 therein to space a center portion 43 away from the outer
portion of the cap so that the cap will engage both the external
and internal surfaces of the tubular fitting 7. The engagement is
firm and airtight by virtue of the fitting 7 having opposite tapers
on the inside and outside thereof, the cross-sectional area of the
fitting decreasing externally upwardly and internally downwardly.
To the closed end of the inner portion 43 of the cap one end of a
stylet 44 is secured, the stylet extending downwardly through the
fitting 7, the port 20 and through the valve seat 23 to terminate
adjacent the upper end of the valve 32. While this stylet is
flexible, it nevertheless is sufficiently rigid or stiff to prevent
the valve from closing in the seat 23 as long as the cap 40 remains
in position on the fitting 7. A tie cord 45 is secured at one end
to the cap 40 and at the other end to a collar 46 disposed around
the fitting 6 so that the cap cannot be misplaced when removed from
the fitting 7 at the time the unit is put into operation.
The fitting 6 has the same opposite external and internal tapers as
the fitting 7, and the cap may be pressed over the fitting 6 at the
conclusion of operation in a leak-proof engagement, and the cap
requires considerably more strength to dislodge than to place it in
position. On the inside of the cover the fitting 6 is substantially
half cut away as indicated at 47 leaving a half tube with the
convexity thereof facing the valve assembly. This shaping performs
two functions, namely, directs incoming patient drainage downwardly
and does not permit it to cross directly toward the valve; and it
also prevents siphoning if for any reason the drainage fluid rises
to the lower end of the fitting.
In operation, the use of the disposable unit is extremely simple,
Originally the disposable unit is packaged in collapsed style and
so little storage space is needed for a quantity of the units. Each
unit is wrapped in a sterile wrapper and when put to use it is
simply necessary to insert the liner 4 inside the canister, press
the cover 3 in airtight engagement with the canister, remove the
cap 40 and connect the fitting 7 to a source of suction, and
connect the fitting 6 to the patient's body. When suction is then
turned on, drainage immediately begins and the vacua inside the
canister and outside the liner, and inside the liner and inside the
float are all countervailed or equalized. It is important to note
that when the drainage collects in the liner to a point where it
starts elevating the float, moving the valve toward closed
position, buoyancy of the float alone is not relied upon to seat
the valve. When the valve rises where it is partially between the
notches 27--27 in the neck 26 of the float housing, the valve is
directly in the air stream caused by suction through the port 20
and this suction then closes the valve with much more force than
buoyancy alone can provide and the valve will not thereafter become
dislodged.
If operation is manually stopped before the level of drainage
reaches the float, this is simply accomplished by snapping the
flip-tab 37 and pulling the cord 35 using as much force as desired.
Of course, if the pull cord 35 is used to raise the valve while the
vacuum is still applied the vacuum, in the manner above described,
would aid in seating the valve, but such aid is not necessary since
adequate seating can be obtained by pulling on the pull cord.
After the valve is closed in either manner, the vacuum tube 12 may
be disconnected from the fitting 7, the patient tube 11
disconnected from the fitting 6, and the cap 40 pressed into
position over the fitting 6. The disposable unit then is completely
sealed aseptically and may be disposed of along with its contents
without fear of leakage, and nothing is left to be sterilized
before a new unit is placed back in the canister.
The modification shown in FIGS. 6 and 7 operate substantially the
same as that previously described and is equally as efficient. In
this instance, however, the valve 32 has a solid stem 48 seated in
the neck 30 of the float. It is therefore necessary to provide a
slot 49 in the float neck which is longer than the valve stem so
that the vacuum in the float may be countervailed or equalized to
the vacuum in the liner 4. A pull cord 50 is provided to manually
close the valve, one end of the cord being tied at 51 to the
outside of the float housing immediately above the bottom thereof
and the cord extends transversely through the housing underneath
the float exiting from the housing through an elongated slot 52 and
then extending upwardly through a self-sealing plug 53 in the cover
3 and terminates exteriorly of the cover in a knob 54 by which the
cord may readily be grasped. With this form of the invention, it is
merely necessary to grasp the knob 54 and pull up on the cord 50
from the position seen in FIG. 6 to that seen in FIG. 7 in order to
manually seat the valve. Once the valve is seated, the connections
to the patient and the suction line removed from the fittings 6 and
7, and the cap 40 place over the fitting 6, the disposable unit
including its contents is ready for discarding.
* * * * *