Note: Descriptions are shown in the official language in which they were submitted.
Background and Summary
This application is a division of copending
Canadian application Serial No. 263,881 filed October 21,
1976.
Sterile irrigating fluids, commonly consisting
of distilled water, normal saline, or physiological solutions
of sorbitol or glycine, are widely used for post-oparative
irrigation, for flushing wounds and body passages, cavities,
and other areas undergoing surgical examination or operation.
For example, continuous or interm~ttent irrigation is commonly
required during transurethral prostatic xesections and for
cystoscopic examinations. Surgical apparatus particularly
suitable for irrigation in transurethral resections is dis-
closed in co-owned United States patent 3,677,248.
The manner of administration of such irrigating
fluids depends on the type of examination or treatment
involved and particularly on the ~uantities of fluid required~
Relatively large quantities are frequently needed for flushing
purposes and, in those cases, the surgeon or assistant may
simply remove the closure and pour the fluid directly from
the bottle. In other instances, as where a stream of
irrigating liquid is to be directed through a cystoscope
or resectoscope, the instrument is attached to the flexible
tubing of an administration set with the connector of that
set being secured to the bottle in place of its original
closure.
Administration sets for irrigation fluids are
available with different forms of bottle connectors but each
form has some shortcomings in terms of cost, inconvenience
of use, and/or possible risks of fluid contamination. For
example, one connector takes the form of a threaded cap to which
the flexible tubing of the administration set is
permanently secured, Substitution of that cap for the
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original threaded bottle cap obviously requires considerable
manipulation and time. In another arrangement, the connector
comprises a plug which need only be inserted into the mouth `
of the bottle; however, such a procedure still requires
prior removal of the bottle's original cap.
One aspect of the invention as defined in the
parent application in providing a dual-purpose closure for
an irrigation bottle and, specifically, a closure which
constitutes the original closure of the bottle, which is to
be left in place when the irrigating fluid is to be
administered through an administration set, and which is to
be removed only if circumstances require that fluid be poured
~rom the bottle. While it is recognized that closure with
piercable membranes are widely used for intravenous adminis-
tration of blood and parenteral fluids, such closures are
ordinarily secured against removal (see, for example, United
States patent 2,730,097) and would be clearly unsuitable for
use in the administration of irrigation solutions for that
reason alone and also because of their relatively èxpensive,
~0 ordinarily multiple-piece, construction.
The invention as defined in the parent application
is concerned with a relatively simple, inexpensive one-piece
molded plastic closure which functions as the origina} closure
~or the bottle of surgical irrigation fluid and which is
readily unthreaded from the bottle when fluid is to be poured
~xom that bottle. When instead the fluid is to be drained
~hxou~h an administration set, the imperforate closure is left
in place and the connector of the administration set is
frictionally coupled to the closure with a hollow spike portion
of the connector piercing a wall portion of the closure. Thus
either closure removal or administration set attachment may be
easily and quickly accomplished -- advantages which are
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particularly important in the surgical field where any
delays may have serious consequences.
Broadly speaking the invention according to the
parent application provides a closure for containers for
surgical irrigation fluids and the lime, the closure having
a generally cylindrical side wall, an annular top wall, a
tubular sleeve extending downwardly from the inner perimeter
of the top wall, and a bottom wall closing the lower end
of the tubular sleeve, the tubular sleeve and the side, top
and bottom walls being integrally formed of semi-rigid plastic
material, the side wall having threads along the inner surface
thereof for threadedly engaging the neck of a fluid container
and for removably retaining the closure in sealing relation
therewith, the sleeve being substantially smaller in diameter
than the side wall and having along the upper inner surface
thereof an inwardly-projecting annular rib portion defining an
annular zone for slidably and sealingly engaging a connector
spike insertable into the sleeve.
As indicated, the one-piece closure is formed of semi-
rigid plastic and has a generally cylindrical side ~all, anannular top wall, a tubular sleeve communicating with the central
opening of the top wall, and a bottom wall closing the lower
end of the sleeve. Within the sleeve, at a level just below
the top wall, is the annular rib which projects into the cavity
of the sleeve and which provides a primary sealing zone for
slidably and sealingly engaging the outer surface of a connector
spike insertable into the sleeve to pierce the bottom wall of
that sleeve and to place the interior of the irrigation bottle
in flow communication with an administration set. In the
embodiment discloses hereinafter, the sleeve is downwardly
tapered and has along its inside surface a secondary sealing
zone spaced between the primary
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zone and the bottom wall of the sleeve. The bottom wall
may have a dome-shaped upper surface which facilitates proper
positioning and cutting action of the piercing spike.
On the other hand the invention according to
the present application defines a connector for coupling
attachment to the closure of a solution bottle, the connector
comprising a handle and spike formed integrall of rigid plastic
material, the spike having a tubular wall terminating at its 1
lower end in a beveled cutting edge, the cutting edge sloping
upwardly from a tip portion towards a heel portion of the
spike, the heel.portion being provided with an upwardly-
extending smoothly contoured recess interrupting the cutting
edge.
~ he spike is provided with an angularly-beveled
cutting edge terminating at its lower end in a peripherally-
disposed tip, has a lower portion of smaller external diameter
than the upper portion thereof, and includes a separate airway
for the introduction of filtered air into the bottle as its
contents are drained. Because of an enlarged recess formed
in the heel portion of the spike, insertion of the spikekhrough the bottom wall of the closure results in the
~ormation of a flap which is pushed aside (so that it does
not obstruct li~uid flow) but is not detached from the closure.
Other features, advantages, and objects of the
invention will become apparent from the specification and
drawings.
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Drawings
Figure 1 is a persective view of a closure and
connector embodying this invention.
Figure 2 is an enlarged vertical sectional view
of the elements illustrated in Figure 1, prior to coupling
of the closure and connector.
Figure 3 is a fraamentary sectional view of the
parts depicted in Figure 2 but showing such parts just as
the closure is pierced.
Figure 4 is a fragmentary sectional view similar
10 to Figure 3 but showing the connector fully inserted into
the closure.
Figure 5 is a fragmentary sectional view taken
along line 5-5 of Figure 4.
Figure 6 is a fragmentary sectional view taken
along line 6-6 of Figure 4.
Figure 7 is a fragmentary plan view taken along
line 7-7 of Figure 2.
Figure 8 is a sectional view taken along line
8-8 of Figure ~.
Figure ~ is a fra~mentary sectional view taken
along line 9-9 of Figure 2.
Description
Referring to the drawings, the numerals lO and 11
generally designate the closure and connector, respectively,
for the administration of surgical irriga~ion fluids. The
closure 10 comprises a one-piece plastic cap having a
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cyllndrical side wall 12, an annular top wall 13, a tubular
sleeve 14 e~tending downwardly from the inside circum~erence
of the top wall, and a bottom wall 15 closing the lower end
of the sleeve. Since all of the walls are imperforate, the
closure effectively seals the bottle 16 to which it is
secured.
The bottle itself is conventional, being formed
from glass, plastic, or any other suitable material in
accordance with teachings and practices known in the art,
10 and a detailed descri~tion of the bottle is therefore
believed unnecessary here. It is to be noted, however, that
the bottle is provided with a threaded neck 16a received
within the annular space between side wall 12 and sleeve 14,
and that the side wall is internally threaded for detachable
connection to the bottle neck. Thus, when irrigating fluid
is to be poured from the bottle, the closure is simply
unthreaded from the neck in the usual manner.
The tubular sleeve 14 is spaced a substantial
distance inwardly, not only from the inside surface of side
20wall 12 but also from the inner surface o neck 16a to which
the side wall is threadedly connected. Such spacing is
important because it accommodates outward flexure or
stretching of the sleeve's tubular wall during a coupling
operation as will be described more fully hereinafter.
The tubular sleeve is provided with an inwardly
projecting annular rib 17 formed along its inner surface at
a level adjacent to, but slightly below, the level of top
wall 13. Below the rib, the inner surface 18 slopes or
tapers gradually inwardly and downwardly so that the inside
30 diameter of the sleeve at its lower end is less than the
diameter of the opening defined by rib 17. ~n annular band
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or 70ne 19 of the inner surfa~e, lndicated hy dashed lines
in Fi~ure 2, encompasses that portion of inner surface 18
which has substantially the same inside diameter as rib ]7.
~bove the rib, the sleeve is provided with an upwardly and
outwardly Elared upper surface 20 which not only hel~s to
guide a connecting spike into the sleeve but also results
in a reduced thickness of material at 21 where the sleeve
merges with the top wall. Such reduced thickness contributes
~ in permitting outward stretching or flexure of the sleeve
lOin its primary sealing zone when a spike is forced into the
sleeve as described below. While the angle of upper surace
20 may vary, it has been found that particularly effective
results are achieved if the surface slopes upwardly and
outwardly (or do~7nwardly and inwardly) at an an~le within
the ranqe of 40 to 70 degrees when measured from the horizontal,
the pre,ferred range being approximately 60 degrees.
Bottom wall 15 is dome-shaped in configuration and,
in comparison with the other walls, is relatively thin,
especially along its annular outer portion 15a which merges
20with the lower end of tubular sleeve 14. While the thickness
o~ portion 15a may vary considerably dependinq upon the
material used and the construction and composition of the
pi~rcing spike, it has been found that a minimum wall
thickness of approximately 0.005 to 0.020 inches is effective
1~ a high density polyethylene (having a density within the
a gencral ran~e of 0.940 to 0.965 ~rams per cubic centimeker)
is used. It is to be understood, of course, that other
semi-rigid plastic materials having similar properties may
be used in the fabrication of the closure. In addition to
30 having good barrier properties and chemical inertness, the
selected material should be relatively stiff (i.e., should
have a stiffness modulus of at least 50,000 psi when measured
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~y ~ST~ test method D747-63T), so that a secure threaded
connection will he formed between the side wall 12 and
bottle neck 16a, and should h~ve sufficient hea~.resistance
to withstand autoclaving temperatures (250 degrees F.).
The dome shape of bottom wall 15 may he formed
entirely in the molding operation, although it has been
found that full development of the dome-shaped con.~iguration
may be obtained at least in part by increased pressure
within bottle 16 when the sealed and filled bottle is
lOsubjected to sterilizing temperatures with cap 12 in place.
Specifically, during such an autoclaving procedure, the
thermoplastic material of the closure tends to soften, the
bottom wall 15 assumes a fully-developed domed confi~uration
as shown because of the increased internal pressure and also
possibly because of limited shrinkage of the plastic, ancl
upon cooling the plastic sets to retain the dome-shaped bottom
wall configuration shown.
The connector ll consists essentially of a handle
20Or body portion 22 and a spike 23. The spike has a tubular
wall 2q terminating at its lower end in an angular cutting
ed~3e 25. While the spike is illustrated as having a single-
bevel cutting edge, plural bevels may be provided as long as
th~ cutting edge slopes generally upwardly ~rom a ~eripherally-
disposed tip portion 26 towards a ~iametxically-opposing heel
portion 27. An enlarged xecess 28 is formed in the heel,
extending upwardly as shown in Figures 2, 5, and 8. ~ main
passage 29 for the flow of ixxigation fluid extends through
the hollow spike and into the hody portion, communicatin~
30with socket 30 which is in turn adapted to receive and retain
the plug portion 31 of administration tube 32. The tube and
its plug are entirely conventional and are therefore illus-
trated only in phantom. It is to be understood tha~ the
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opposite e~d o~ th~ ~ube ls adapted for connection to any
of a variety of catheters, instruments, and other devices
for the administration o~ irri~ation fluids, and that if
desired, the plug 31 may be eliminated and ~ube 32 may be
joined dixectly to the connector 11.
An airway 33 also extends through the hollow spike
and, as shown most clearly in Figures 2 and 8, is separate
from main passage 29. The airway extends to the tip portion
26 of the spike and, at its opposite end, communicates witll
10 a recess 34 in handle or body portion 22. A filter unit 35,
containing a non-wetting microfilter of standard construction,
is secured to the connector in flow communication with recess
34. The filter permits air, filtered for parti.culates and
bacteria, to enter the bottle as its contents are drained
without allowing li~uid to escape through airway 33.
It is to be noted that the outside diameter of the
upper portion 23a of the spike is substantially gxea-ter than
the outside diameter of lower portion 23b. Speci~ically,
upper portion 23a has outside dimensions slightly greater
20 than the opening defined hy annular rib 17 in sleeve 14.
The lower portion 23b has a smaller outside diameter than
the inside diameter of the rib, the spike's mini~um outside
diameter bein~ the same or slightly less than the minimum
inside diameter of the sleeve at the lo~er end thereof. It
should be observed that the length o~ the spike substantially
exceeds the length of sleeve 14 and, specifically, that the
length of reduced lower portion 23b (measured:~rom heel 27
to the upper end of portion 23b) exceeds the distance between
rib 17 and bottom ~all 15. In addition, the length of the
30 enlarged upper cylindrical portion 23a exceeds the distance
between rib 17 (the primary sealing zone) and the secondary
lower sealing zone 19.
626
The body or handle portion o~ the spike preferably
includes wing portions 22a which m~y b~ readily gri~ped to
hold the connector between the fin~ers o one hand ior
driving the spike into fully seated position within the
port sleeve of the closure. The body por~ion and spike of
tile connector are integrally formed of a rigid mat:erial.
A rigid plastic such as polystyrene is l~referred, althou~l
other plastic materials having similar properties of
strength, rigidity, and hardness, or other materials such
10 as metal, might be used. The rigidity or stiffness of the
material of the connector 11 should be substantially greater
than that of closure 10.
In operation, if the contents of the hottle are
to be drained through an administration set, then any
conventional protective co~er (not shown) that may be provided
over the entrance to the sleeve (to maintain the sterility
of the surfaces thereof) is first removed and connector 11
of the administration set is then coupleA to the closure by
inserting spike 23 into the open-topped sleeve 14 in the
20 manner illustrated in Figures 2-4. The reduced lower end
portion 23b of the spike enters the sleeve and is freely
sl.idable therein because o~ the greater internal dimensions
o the sleeve. Tip 26 engages the periphery o bottom ~all
15, piercing that wall and commencing the formation of an
a~cuate slit that e~tends about almost the entire periphery
o~ ~hat wall. Since the cutting edge 25 is interrupted
at heel portion 27, the cutting action is similarly
interrupted, resulting in the formation of a flap 36 which
~olds downwardlyabout hinge line 37 to make way for the
30descending spike (Figure 3). The bottom wall therefore
remains connected as flap 36 to the remainder of the closure
and is not released into the body of fluid within the
container. Furthermore, recess 28 enhances fluid drainage
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from the container and accentuates the separation of fluid
removal from air ent~in~ via -the air passa~eway ~3. The
benefit of t}lis is a reduced tendency to ent~ap air bubbles
in the mainstream at high flow rates, wilicll bubbles, if
carried all the way to the resectoscope or other instrument
to which the administration tube is connccted, might
adversely affect the sur~eon's view of the operative area.
Thereafter, following the piercing and cutting
action, the enlarged upper portion 23a o the spike slidably
10 and sealingly engages the p~imary sealing zone defined by
annular rib 17 (Figures 4-6). Since the outside diameter
o~ the spike's upper portion 23a is greater than the inside
diameter of the upper sealin~ zone, slight outward 1exure
or stretching of the sleeve occurs in the vicinity of the
rib. A~s already indicated, such outward displacement of the
rib portion is aided by reason of the fact that tile rib is
spaced below the level of top wall 13 (i.e., below the under-
surface thereof) and because of the reduced wall thickness at
21. Finally, the enlarged portion 23a of the spike enters
20 into enga~ement with the inside surface of the sleeve at the
secondary sealing zone 19, causing further outward 1exure
or stretching of the sleeve at that location (Fi~ures 4-6).
Positive and highly effective sealin~ between the connector
and closure is thereby achieved. The grippin~ forces exerted
by the stretched sleeve upon the spike are sufficiently
~reat to prevent extraction of the spike when the bottle is
inverted or administration and even when pullin~ forces of
considerable magnitude are exerted upon the flexible tube.
During insertion of the spike into the port sleeve,
30 should misalignment of ~he parts occur the flared upper
surface 20 will tend to realign or center the spike. ~urther-
more, should the spike be introduced at an an~le, the
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cooperative action b~t~een th~ out~r suxfac~ o~ lower
spike portion 23b, and the la~eral sliding action which
tends to occur as tip 26 ~nga~es ~he domed top sur~ace of
wall 15, results in automatic realignment of the
descending spike.
Throughout the specification, closure 10 has been
referred to as a "one-piece" closure to make it clear that
the tubular port sleeve, which is piercahle by and sealingly
engagable with spike 23, is integral with top wall 13 and
10 threaded side wall 12. It ïs to be understood, of course,
that where the outer surface of the closure must be
maintained in sterile condition, some outer cover (not shown)
o~ any suitable or conventional design may be provided.
Also, while the closure shown in the drawings is provided
with a ribbed top wall 13 which sealingl~ en~a~es the
mouth of bottle 16, an annular resilient .Ziner m~y i
desired be interposed between the mouth and the underside
of the top wall to contribute in forming an effective seal
between the parts.
~0 ~hile in the foregoing an embodiment of the
invention has been disclosed in considerable detail for
purposes of illustration, it will be understood by those
skilled in the art that many of these details may be varied
without departing from the spirit and scope of the invention.
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