CA1091626A - Connector spike for ported closure - Google Patents

Abstract

ABSTRACT
A connector spike for use with a dual-purpose one-piece plastic closure for surgical irrigation fluid containers is disclosed. The closure has a port sleeve which has a primary sealing zone at a level slightly below the closure's top wall, and a secondary sealing zone between the primary zone and the dome-shaped bottom wall of the port sleeve. The connector has a handle portion and a spike portion with the tubular wall of the spike portion terminating in a beveled cutting edge which is adapted to pierce the bottom wall of the closure. The cutting edge slopes upwardly from a tip portion towards a heel portion, the latter being provided with an upwardly extending smoothly contoured recess which interrupts the cutting edge.
The wall of the spike portion has upper and lower portions of different diameter for engaging the primary and secondary sealing zones of the closure respectively. The recess contributes in preventing air entering an inverted solution bottle from becoming entrained in liquid being drained from that bottle.

Description

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 ywl ~ 2 ~

~9~62!~i 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 ywl/~ 3 i i26 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 yW~ 4 _ ~ S~J ~

9~62~

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 ~0~6Z6 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 ~og~26 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 lOgl6Z6 ~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 16iZ6 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.

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 1 r!

1 [)9~6Z6 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 -- l.~. --91~;Z6 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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Claims (4)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A connector for coupling attachment to the closure of a solution bottle, said connector comprising a handle and spike formed integrally of rigid plastic material, said spike having a tubular wall terminating at its lower end in a beveled cutting edge, said cutting edge sloping upwardly from a tip portion towards a heel portion of said spike, said heel portion being provided with an upwardly-extending smoothly contoured recess interrupting said cutting edge.

2. The structure of claim 1 in which said spike is provided with a lower portion extending upwardly from said tip and an upper portion interposed between said lower portion and said handle, said upper portion having a cylindrical outer surface of substantially greater diameter than said lower portion.

3. The connector of claim 2 in which said spike is provided with separate air and liquid passages extending therethrough, an opening for said air passage at the lower end of said spike being provided adjacent said tip portion and a separate opening for said liquid passage being disposed adjacent said recessed heel portion, whereby, the recess of said heel contributes in preventing air entering an inverted solution bottle from becoming entrained in liquid being drained from that bottle.

4. The connector of claim 2 or claim 3 wherein the diameter of said spike increases gradually between said lower portion and said upper portion.