Holbrook, Le Grand K. (Salt Lake City, UT)
Ostler, David S. (Salt Lake City, UT)

04/851955

03/07/1972

08/21/1969

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Medical Development Corporation (Salt Lake City, UT)

604/319

604/129, 215/309, 141/325, 15/314, 137/216

A61M1/00; A61M1/00

128/272,275-278,300 137/143,151,216 141/230,325

Rosenbaum, Charles F.

We claim

1. A body fluid collection bottle including, in combination, a disposable, downwardly tapered container, a molded plastic cover, of the same nominal wall-thickness as that of said container, disposed over said container and having, as integrally molded portions of said cover, elongate body fluid port means and elongate vacuum supply port means extending on opposite sides of said cover, said cover including body fluid conduit means connected to said body fluid port means and thereby communicating through said cover into the interior of said bottle as bounded by said container and cover, and a vacuum conduit secured to said vacuum supply port means of said cover and communicating therethrough with said interior.

2. A body fluid collection bottle including, in combination, a disposable, downwardly tapered container having an upper, annular inner edge, a cover disposed over said container, said cover including body fluid conduit means communicating through said cover into the interior of said bottle as bounded by said container and cover, and a vacuum conduit secured to said cover and communicating therethrough with said interior, and wherein said tapered container includes an upper cylindrical margin, a frustoconical outer side surface, and a downwardly facing shoulder disposed therebetween and constructed to constitute a reaction surface for an annular supportive mount, the annular juncture of shoulder with said frustoconical outer side surface being congruent and vertically, coaxially aligned with said inner edge.

3. A body fluid collection bottle including, in combination, a disposable container, a cover disposed over said container, said cover including body fluid conduit means having an interior communicating through said cover into the interior of said bottle as bounded by said container and cover, and a vacuum conduit secured to said cover and communicating therethrough with said interior, and wherein said bottle includes cylindrical, tubular means, having opposite open ends, mounted to said cover circumscribing yet spaced from the interior of said body fluid conduit means, and positioned and contoured to provide air passageway means proximate said body fluid conduit means between said body fluid conduit means' interior and said vacuum conduit for coacting with said body fluid conduit means to prevent backflow siphoning through said body fluid conduit.

4. Structure according to claim 3 wherein said coacting means comprises a tube depending from said cover, said tube being coaxially aligned with respect to said body fluid conduit and having an interior which is cross-sectionally enlarged with respect to the downward cross-sectional projection of said body fluid conduit, said tube including side wall aperture means.

5. A body fluid collection bottle including, in combination, a disposable container, a cover disposed over said container, said cover including body fluid conduit means communicating through said cover into the interior of said bottle as bounded by said container and cover, and a vacuum conduit secured to said cover and communicating therethrough with said interior, wherein said bottle includes means coacting with said body fluid conduit to prevent backflow siphoning through said body fluid conduit, and wherein said body fluid conduit extends beneath said cover, said coacting means comprising a cylindrical tube, open at opposite ends, and circumscribing said body fluid conduit and being circumferentially spaced at a spaced area therefrom above the lower extremity thereof, said tube being contoured and positioned to provide aperture means communicating with said spaced area.

6. Structure according to claim 5 wherein said aperture means is disposed above the lower extremity of said body fluid conduit.

7. In a fluid collection bottle having a fluid port and a vacuum port, an improvement comprising a cylindrical tube, open at opposite ends, disposed in said bottle and communicating with and circumscribing said fluid port, said tube including structure providing aperture means for equalizing gaseous pressure, for all operating fluid levels within said bottle, within said tube and beneath said fluid port with that present exterior of said tube within said bottle.

8. Structure according to claim 7 wherein said fluid port includes a depending portion depending within said bottle and having a lower end, said tube circumscribing said depending portion and extending therebeneath.

9. Structure according to claim 7 wherein said aperture means is disposed above the lower extremity of said depending portion of said fluid port.

10. In a fluid storage bottle having a container and a cover secured thereto, said bottle including a fluid inlet port and a vacuum port, an improvement wherein said bottle includes a storage-rollable flexible tube extending downwardly therein, affixed to said bottle, and disposed in communication with said inlet port, said cover being constructed at said fluid inlet port to permit gaseous flow between said fluid inlet port and said flexible tube to that region of the interior of said bottle outside of said flexible tube.

11. A body fluid storage bottle including, in combination, a container, a cover disposed over said container in operating vacuum-retaining relationship, said bottle including a body fluid inlet port and a vacuum port communicating with the interior of said container, said container having a tapered interior surface terminating in an upper edge, an upper, outer exterior, cylindrical margin, a lower, tapered, frustoconical outer side indented with respect to said cylindrical margin and joined thereto at a common, transverse abutment shoulder, the juncture of said abutment shoulder with said frustoconical outer side being congruent with and coaxially aligned vertically beneath said upper edge of said tapered interior surface, said container thereby being dimensioned such that said abutment shoulder is operative to prevent stacked containers' overinsertion as well as to provide an individual container's annular support abutment.

12. In a fluid collection system including a fluid storage bottle having fluid inlet means and a vacuum port, and a vacuum pump, an improvement wherein said vacuum port includes an outwardly extending tapered extension, a vacuum tube having one end connected to said vacuum system, a rigid end fitting secured to the remaining end of said vacuum tube and having a tapered wedging socket, said wedging socket being wedgingly secured to and over said tapered extension of said vacuum port.

The present invention relates to body fluid bottles usable in surgery and recovery rooms, by way of example, and more particularly, to a new and improved body fluid bottle incorporating a number of advantages over existing bottles, especially in provision of means for preventing the inadvertent siphoning of body fluid within the bottle when gaseous pressure therein is raised above the normal, operating vacuum condition.

In the past a few types of body fluid or blood storage bottles have been devised for use in hospitals. Those types of which the inventors are aware generally constitute portions of permanent systems wherein the bottles are in a glass or Pyrex, are reused and therefore are required to be sterilized both as to the container and also as to the rubber or metal cap thereof between successive uses. Prior attempts have also been made in devising a disposable system wherein the lid of the vessel includes a depending, deformable, closed-ended plastic encasement which, when filled, conforms to the inner wall of a rigid outer container. The latter has proven somewhat unsatisfactory in that the same cannot be a closed, sealed unit; accurate reading as to fluid level relative to the outer rigid container is difficult; the throwaway portion of the unit is expensive; antisiphoning means are lacking, and so forth.

Accordingly, a principal object of the present invention is to provide a new and improved vessel, hereinafter referred to as a "bottle," for receiving body fluids, such as blood, which are drained from the body of a patient.

A further object is to provide a body fluid bottle incorporating antisiphoning means, this to prevent backflow through the body fluid tube if gaseous pressure within the bottle above the fluid level is raised above the normal operating vacuum conditions.

An additional object is to provide a new and improved body fluid bottle which is disposable and easily incinerated.

An additional object is to provide a body fluid bottle comprising a disposable container and also a cover releasably lockable thereto.

An additional object is to provide a closed fluid-storage system wherein the bottle or storage vessel, and any contaminated fluids therein, can be sealed within the bottle, by the fluid tube leading from the patient, and thereafter disposed of, this through such tube being looped and connected from the fluid inlet to the vacuum port of the vessel.

An additional object is to provide, in a body fluid vessel or bottle, a cover or lid for a container wherein the cover incorporates advantageous vacuum and body fluid ports or conduits.

An additional object is to provide in or for a body fluid bottle a tube equivalent member which depends beneath and communicates with the body fluid port of the bottle, with suitable aperture means being provided to allow for equalization of gaseous pressure within the tube to that above the fluid level in the remainder of the bottle, thereby to prevent siphoning back in the direction of the patient.

An additional object is to provide in the body fluid bottle suitable means for preventing backflow or siphoning of fluid within the bottle out of the body fluid tube connected thereto back to the patient, should increase in gaseous pressure above the normal vacuum conditions chance to occur above the fluid level within the bottle.

A further object of the invention is to provide a new and improved body fluid bottle wherein covers thereof are easily packaged and containers thereof easily stacked inside each other for compact packaging.

A further object is to provide an antisplash device in a body fluid storage bottle.

A further object is to provide a container, plural ones of which can be insertably stacked in a manner that, upon withdrawal of one container, exposure to ambient conditions of the inside surfaces of the remaining containers will be minimized.

According to the present invention, the body fluid bottle thereof preferably takes the form of a disposable container and cover combination, the two being constructed for locking or other securement together in vacuum seal relationship. The cover is provided with two or more ports or conduits serving as exterior body fluid and vacuum connections, all of which are communicatively disposed through the cover and within the container of the bottle. The container itself includes an upper lip or margin and also a frustoconical outer side, this to permit the containers to be inserted in each other and stacked, stored, or packaged in very compact packaging. A special feature is present, in one form of the invention, in the combination of the body fluid conduit wherein outer, spaced tubular means surrounds the interior extension of the conduit and is provided with suitable aperture means so as to permit the equalization of gaseous pressure within the container above the fluid level, both inside and outside the tubular means. Such tube likewise preferably extends downwardly a considerably distance, this to avoid splashing and foam of the body fluid as the same enters the container.

The features of the present invention which are believed to be novel are set forth with particularity in he appended claims.

The present invention, both as to its organization and manner of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in connection with the accompanying drawings in which:

FIG. 1 is an elevation, principally in enlarged section, showing the body fluid bottle of the present invention as being supported by a wall bracket and being used with the vacuum system drawing blood or other body fluid from a patient into the bottle proper.

FIG. 2 is an enlarged detail of the upper left hand portion of the body fluid bottle of FIG. 1, showing a slight modification in the antisiphoning means used.

In the drawings body fluid bottle 10 is shown to be comprised of container 11 and a cover 12, the latter being interlocked with the former as by threads, cam surfaces, Leur locks, or other suitable means. While these two members 11 and 12 may be unitary, if desired, it is deemed preferable that the two comprise separate plastic parts which are releasably secured together by threads, cooperative cam surfaces, or other means 13 and 14 in a conventional manner. Container 11 has a tapered interior surface F and also preferably has frustoconical exterior side 15 and an upper cylindrical margin 16, these two having depending shoulder 37 as a common juncture surface. The annular juncture J of shoulder 37 with exterior side 15 is congruent and coaxially vertically aligned, see FIG. 2, with the interior annular edge E of the container lip, to accommodate lip-to-shoulder container stacking. Thus, where the containers 11 are so configured they may be insertably stacked together much in the manner as conventional paper drinking cups for packaging purposes. The upper edge or surface 17 of container 11 is preferably flat, and when cover 12 is caused to tightly engage the cooperative means 13 and vacuum is applied, the surface 17 will be sealed against bottom surface 18 of cover 12. Cover 12 itself includes a vacuum conduit 19 and a body fluid conduit 20, the two preferably taking the form of tubes, in effect, medially disposed through the cover such that opposite ends of conduits 19 and 20 are present at opposite sides of cover 12.

Vacuum system 21 may comprise a combination motor-driven vacuum pump and the vacuum orifice or nozzle 22 thereof is connected via rubber vacuum tube 23 to end fitting 24 thereof. This connection can be made by cement, if desired, as at 25. End fitting 24 has, of course, a central aperture 26 communicating with aperture 27 of vacuum tube 23. Of course, tube 23 may be simply pressed over the turned down end 28 of end fitting 24, if desired. The interior of end fitting 24 is preferably made in the form of a conical wedge-type cavity 29 for receiving the frustoconical end 20 of vacuum conduit 19. A similar connection is made as between end fitting 31 and body fluid tube 32, the former being connected to body fluid conduit 20 in a similar manner. It is seen that the body fluid tube 32 will be used at the situs of the operating table or recovery room, for example, and may have an appropriate conventional end fitting, not shown, for application to the operative area of the patient.

The body fluid bottle of the present invention may be supported by a wall bracket 33 as by screws 34 fastening the same to wall 35. The wall bracket 33 includes a circular band R which supportingly engages container 11 in the manner shown. It is seen that the shoulder 37 of the container not only serves as a stop abutment for a series of stacked containers 11, to preclude overinsertion when the same are stored or packaged, but also provides a supporting abutment for a single container 11 so as to adequately support the same.

Of special importance in the present invention is the inclusion of an inlet tube 36. This tube may be flexible and, for packaging purposes, may be rolled and fastened integrally to cover 12 for installation in a sterile package of conventional design. Tube 36 is seen to be spaced, see space S, from area A of body fluid conduit 20, but nonetheless includes a closed end 37' having aperture 38 tightly fitting that portion of body fluid conduit 20 beneath cover 12. Of special importance is the inclusion of one or more apertures B in tube 36, preferably disposed above the level of end 39 of conduit 20. The purpose for these important apertures will be described hereinafter. Suffice it to say presently that a space S in annularly provided about the lower portion of body fluid conduit 20 in the manner indicated. Tube 36 may be cemented in place, simply pressed over the lower extremity of body fluid conduit 20, or may be molded or otherwise made integral therewith or attachable thereto or to the cover proper.

FIG. 2 illustrates that if desired, a smaller tube 36, labeled 36' in FIG. 3, may be employed in connection with its circumferential fitting about area A of body fluid conduit 20.

The structures shown in FIGS. 1 and 2 operate as follows. Preliminarily, the container 11 may be stored with a series of mutually inserted, stacked containers 11 in a preferred condition. Correspondingly, cover 12 may be closed in a separate sterile container or bag, as desired. When, during or after surgery, a body fluid bottle or vessel is desired, then the same is assembled by attaching to a respective container 11 and a respective cover 12. As to cover 12 the inlet tube 36 may already have been installed upon body fluid conduit 20 in the manner indicated; or, a separate inlet tube 36 may simply be pressed over the lower half of the body fluid conduit 20 in the manner shown.

In any event, the cover 12 is caused to securely engage container 11 via intercooperating means 13 and 14. Subsequently, vacuum tube 23 is installed and connected to a vacuum system 21 in the manner shown. The body fluid tube 32 with its end fitting 31, is next installed in position, and the lower end thereof is disposed proximate the operative area of the patient, as for example at or near the abdominal cavity.

When vacuum system 21 is turned on, an area of reduced pressure is created within the body fluid bottle 10 and cover 12 seals over lip 17. This is facilitated where the elements of the fluid bottle are made of a suitable polyethylene or polystyrene material, by way of example. The vacuum created within the bottle 10, of course, operates to reduce the air pressure within body fluid tube 32 so that there will be a drawing upwardly of body fluid from the patient up through the body fluid tube 32 down into container 11. Container 11 will continue to fill until a vacuum system is turned off. When the same is, in fact, turned off, then body fluid tube 32 may be removed from the patient and this end inserted over vacuum conduit 19 in lieu of vacuum tube 23. The unit is now sealed and ready for discard under "closed" conditions.

An important feature of the invention relates to operation of tube 36 and body fluid conduit 20. If the vacuum system is turned off, a reduced pressure is maintained within container 11, then the body fluid from the patient will cease filling toe bottle 10, but the fluid within the body fluid tube 32 will remain in such tube. In the event of slight leakage relative to lip 17, or if the pressure within the container commences to rise, then there is present the danger of not only the fluid within body fluid tube 32 returning to the patient, but also the possibility of a siphoning back of body fluid within the bottle 10 back into the operative area of the patient. This, of course, is to be avoided at all cost. The present invention precludes such siphoning back, since any slight increase in pressure within vacuum tube 23, or the container, from the normal operating vacuum condition can now be reflected via apertures B to that column of liquid within tube 36 which would otherwise proceed upwardly, under siphoning conditions, up through body fluid conduit 20 and body fluid tube 32. This feature of the present invention, in the nature of the inclusion of tube 36 and above the fluid level within container 11 is likewise transmitted through apertures B AND IN THE SPACE S surrounding the lower end of body fluid conduit 20. Such increase in air pressure thus will be present and directed against any liquid within inlet tube 36, so as to deter this fluid from continuing to rise upwardly through body fluid conduit 20 and body fluid tube 32. In FIG. 2 the same result obtains, and this even though a tube 36' of reduced length is employed.

What is provided, therefore, is a new and improved body fluid bottle preferably taking the form of a two piece unit including container 11 and cover 12. The blood inlet system to the bottle is so configured that return siphoning or suction through the body fluid tube to the patient is avoided in the presence of increased pressure either within the body fluid bottle above the fluid level or within the vacuum system or vacuum tube thereof. Tube 36 in FIG. 1 is deemed preferable to tube 36' in FIG. 2 since splashing at the lower part of the bottle is substantially reduced, thus aiding in determining fluid level at various times of use of the bottle 10.

In addition to disposability, packaging, and feasibility for closed connection and disposal as by incineration, the container 11 of the invention is ideally suited for suspension from an elevated wall bracket, for example. It is contemplated that upon use of the body fluid bottle, the patient tube with the body fluid in that tube, will be secured across both conduits of the bottle and the same remain sealed and available for immediate disposal.

As to the antibackflow means, rather than employ the pressure equalization technique, as above described, a check valve might be used in the body fluid conduit, port, or tube to prevent reverse flow. However, some practictioners might object to employment of such valve means, owing to possible danger of clogging, at the valve, by blood clots.

Moreover, as to apertures B, the same might conceivably be disposed even beneath the lower end of the body fluid conduit; however, this would be less satisfactory than the aperture disposition illustrated since inflow dribblings therethrough and resultant clogging might chance to occur.

The patient end of tube 32 will preferably have an end fitting 30 which, when the customary suction tip (not shown) is removed therefrom will be directly insertable over and connected to the vacuum conduit 19 in lieu of the vacuum tube 23, thereby permitting the bottle and body fluid tube to be disposed of as a sealed unit.

While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from this invention in its broader aspects.