US 3235069 A
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Description (OCR text may contain errors)
Feb- 15, 1966 F. w. BENNETT ETAL STERILE CONTAINER Filed sept. 21, 1962 W QW W www R5. @mhd INVENTO /emzez/CZ. FZULML'am/ennez' United States Patent O 3,235,069 STERILE CDNTAINER Frederick William Bennett, Warminglaurst, England, and Kenneth Aloe Marshall, Clayton, Mo., assignors to Eisenmann Bros. & Waish Limited, a corporation of Great Britain Filed Sept. 21, 1962, Ser. No. 225,268 Claims priority, application Great Britain, Feb. 19, 1962, 6,391/62 6 Claims. (Cl. 20d-63.2)
The present invention relates to sterile containers and more specifically to sterile catheter containers.
ln'the past, it has been the general practice to manufacture medical surgical devices in a clean but nonsterile environment at a factory and to ship such devices to utilizing medical activities in non-sterile packaging. With the advent of technique which provides for the sterilizing of medical surgical devices such as catheters subsequent to their packaging in plastic containers, the demand for medical surgical devices sealed in sterile containers at the point of manufacture has steadily increased. This eliminates the previously required sterilization at the utilizing medical activity. Sterilization at the point of manufacture rather than at the point of utilization has two advantages. First, the cost of sterilization on the production line basis in large quantities is generally more economical. Secondly, carefully controlled sterilization by gamma ray or other radiation techniques is generally more feasible and more reliable at a point of manufacture than at many of the points of utilization.
With this new demand, came new problems. Since medical surgical devices may no longer be sterilized at the point of utilization, the containers in which they are transported must be capable of being opened and having the enclosed device removed without contamination. The containers must be capable of remaining thoroughly sealed against contamination until they are opened to remove the enclosed device. Further, there must be some method of indicating to even a casual observer that a particular container has previously been opened and, therefore, the contents are probably no longer sterile.
It is, therefore, an object of the present invention to provide a sterile plastic container which is capable of being sterilized by gamma ray radiation.
Another object of the present invention is to provide a sterile plastic container which is thoroughly sealed against the penetration of bacteria.
A further object of the present invention is to provide a seal for a container which will readily indicate to a casual observer that the container has been opened subsequent to its original sealing.
Still another object of `the present invention is to provide a seal for a container which is iiexible under varying stresses which may be put upon it.
A principal object of the present invention is to provide a sterile container of a construction that will allow a medical surgical device contained therein to be removed without contamination.
Yet another object of the present invention is to provide a thermoplastic container composed of two tubes which overlap each other to provide an internal length sucient to encompass a medical surgical device and are individually shorter than the device.
A still further object is to provide abutments on the inside of the outer tube of the aforementioned overlapping tubes to limit the extent of the overlapping.
Further objects and advantages will become apparent from the following detailed description taken in connection with the accompanying drawings, in which:
FIG. 1 is a front elevational view of an embodiment of the present invention;
FIG. 2 is a side elevational View of the embodiment of the invention shown in FIG. 1;
FlG. 3 is a partial rear elevational view of the embodiment of the invention sho-wn in FIG. 1;
FIG. 4 is a sectional view taken along the line 4 4 of FIG. 2;
FiG. 5 is a sectional view taken along the line 5 5 of FG. 4;
FIG. 6 is a partial perspective View of the embodiment of the invention shown in FIGS. 1-5 with a sealing means partially removed; and
FIG. 7 is a perspective View of the portion of the embodiment of the invention shown in FIG. 6 with the sealing means being further removed.
While this invention is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail an embodiment of the invention with the understanding that the present disclosure is to be considered as an exempliication of the principles of the invention and is not intended'to limit the invention to the embodiment illustrated. The scope of the invention will be pointed out in the appended claims.
The embodiment of the invention shown in the drawings is that of a container specically designed for a double proximal end catheter. However, those lskilied in the art will recognize that the principles or" construction disclosed by this embodiment are directly applicable to the design of containers for a large number of medical surgical devices by merely having the internal shape of the container altered to enclose the outside dimensions of each particular medical surgical device. The embodiment illustrated in the drawings is composed of two thermoplastic tubes which are arranged in overlapping relationship in such a manner that they may be unsealed from one another, pulled apart and have the enclosed catheter removed, either by sterile forceps or by lightly shaking the catheter down to the capped end of the container while holding the container at a distance from the sterile cloth on which the catheter will be laid, then squeezing the cap around the end of the catheter to hold it while the body of the container is pulled ofi, then placing the catheter on the sterile cloth and releasing it, without danger of contamination. Containers used in the past have not been free from the danger of contamination because they were so constructed that the enclosed catheter could be removed neither by grasping an exposed portion of the catheter by forceps nor by grasping the end of the catheter by squeezing the cap and because contaminated areas were in such cioec proximity to the openings of these prior containers. As will be described presently in greater detail, the present invention overcomes these diiiiculties by providing a long distance between the beginning of a contamination area on the external part of the container and the opening through which the catheter is removed and by having a substantial portion of a catheter outside such opening after the portion of the container covering such opening is removed. The container illustrated in the drawings is composed of a liexible thermoplastic material so that it may bend and yield without breaking during handling. The sterile integrity, as will presently be described, is assured by having a substantial overlapping portion between the two tubes which compose the main structure of the container and by a fiexible and stretchable tape provided with adhesives which maintain the seal between the tubes even though the container is bent, stretched or subjected to other strains.
Referring first to FIGS. l and 2, a container consists of a lirst elongated tube 10 composed of a thermoplastic material generally known in the industry as low density polythene and an overlapping tube or cap 11 composed of a flexible thermoplastic lmaterial known as polypropylene. The polythene tube and the polypropylene tube are transparent to both light and gamma ray radiation. Thus, a catheter 12 may be observed visually through the container and may also be radiated by gamma rays in order to sterilize both the catheter and the interior of the container. One end 14 of the tube 10 is pinched off and sealed while the other end 15 is open for receiving the catheter. By the utilization of this construction, the tube 10 can be formed from continuous extruded tubing which simplifies its manufacture,
The tube 11 provides a snug fit over the tube lil in in order to provide a maximum resistance to the penetration of bacteria. An overlapping portion 17 is defined by the distance from an end 13 of the tube 11 to a set of four abutments 20 protruding from the interior surface of tube 11. An interior portion 21 is the internal space of the tube 11 which is added to the internal space of the tube 10 to make up the total available internal space of the entire container when assembled. This total space is designed to be just slightly larger than that required to enclose the catheter as the catheter lies in a normal stretched-out position. Since the embodiment of the invention as illustrated in the drawings is designed to house a double distal end catheter, the cross section of the container is designed in the shape of an oval as is more clearly illustrated in FIGS. -7. If a single distal end catheter were to be housed, it would be more convenient to malte the tubes and 11 in a substantially circular shape of about half the width of the oval-shaped container illustrated in the drawings. In like manner, the cross section of the tubes can be made in any shape which is desirable to house a particular medical surgical device. The length of the overlapping portion 17 of the tube 11 is made long enough to assure isolation of the uncovered portion of tube 10 from its open end 15 in order that contamination of the external exposed portion of the tube ltlcannot reach its end when any ordinary method of removing the catheter from inside the tube is utilized. For example, when the tube 11 is removed from around tube 10, the exposed end of the catheter i12 can be grasped by sterile forceps and pulled out onto a sterile surface. No matter how the catheter 12 twists as it is being pulled from the open end 15, contamination from the previously uncovered portion of the tube 10 cannot come in contact with the catheter. If it is desired to shake or tap the catheter down into tube 11 and then grasp the catheter by squeezing the tube 11 to engage the end of the catheter this may also be done without having the catheter come in contact with the contaminated portion of the tubes 10 or 11.
It is a well known principle that bacteria cannot travel through a bacteria barrier because they require a certain size opening along a fairly straight path for movement. Thus, the extent of the overlying portion 17 is long enough to obtain a maximum amount of resistance to the penetration of bacteria and the total length of the interior of the container, as defined by the length of the interior or" the tube 10 and the length of the internal portion 21, is made slightly greater than the length of the catheter or medical surgical device to be contained therein. The length of portion 21 is equal to the length of the enclosed catheter or medical surgical device which will protrude from the opening 15 after the tube 11 has been removed when using the forceps method to remove the catheter.
Referring now specifically to FIGS. 4 and 5, the sealing means for the container will be described in greater detail. A green or dark colored high pressure polythene or polyvinylchloride tape 22 coated with a tenacious rubber resin adhesive is wrapped around the open end 18 of the tube 11 to vform a seal between the tube 11 and the external surface of the tube 10. An end 23 of the tape ZZ is covered over by the tape 22 after it has been placed in adhesive contact with the tubes 10 and 11 as is best shown in FIG. 5. The end 24 is folded back upon itself so that the adhesive side of the tape is on the inside of the fold 25 to form a tab 26 as is shown in FIGS. l and 2 in addition to FIG. 5. The tab 26 is conveniently located at the front of the container. Both polythene and polyvinylchloride tapes have particularly good elasticity in all directions. Therefore, they will stretch and contract as the container cornposed of tubes 10 and 11 is bent, stretched or subjected to other stresses.
The point at which a tape crosses its other end has always been subject to providing a small passage along the end of a tape such as the end 23 of the tape 22. Although the overlying portion 17 of tubes 10 and 11 is an effective bacteria barrier, and although the elasticity of the tape 22 and the rubber resin adhesive will generally produce a complete seal against the penetration of bacteria, if desired, a polyvinylacetate adhesive may be applied along the edge 23 as an additional means of preventing any possible access for bacteria. This adhesive is of such a consistency that it will flow down the end 23 under the portion of the tape 22 crossing over the end 23. It remains completely exible to prevent any compression or stressing of the container from breaking the seal thus formed. In addition, the polyvinylacetate adhesive is not changed when subjected to gamma radiation.
Having described the container and sealing structure illustrated in the drawings, the structure which allows a casual :observer to determine whether the original seal has been broken will now be described in greater detail. Around approximately half of the width of the polythene or polyvinylchloride tape 22 is applied a white paper tape 3i) coated with adhesive. The adhesive gives a strong bond between the paper tape 30 and the external surface `of a polythene or polyvinylchloride tape 22. Although the tape 30 may be composed of any paper or even many other materials well-known in the art, a preferred composition is a thin easily delaminated paper which will prevent any possible removal of the tape 30 without destroying or multilating it to a n0- ticeable degree. As is illustrated in FIGS. 3 and 5, the ends 31 and 32 of the tape 30 are located at positions away from the end 24 and the tab 26 of the polythene or polyvinylchloride tape 22. The ends 31 and 32 may be overlapping as is illustrated in the figures or the tape 30 may be short enough so that it cannot completely surround the tube 10 for the ends to overlap. However, it is essential that the tape 30 cover the end 24 and the tab 26 of the polythene or polyvinylchloride tape 22 as illustrated in FIG. 5 in order to assure that the tape 30 is torn whenever the tape 22 is removed from the tubes 10 and 11.
The utilization of the container will now be more fully described. The catheter 12 is placed through the end 15 into the tube 10 as shown in FIGS. 1 and 2. The tube 11 is fitted over the portion of a tube 10 adjacent to the open end 15 until the end of the set of abutments Ztl is in contact with the open end 15 and that portion of the dual proximal end of a catheter 12 which remained outside the tube 19 is enclosed within the interior por.
tion 21. The full extent of the overlying port-ion 17 of the tube 11 is now covering the external adjacent end portion of the tube 10. The polythene or polyvinylchloride tape 22 is then applied as shown in FIGS. 1-5. If desired polyvinylacetate adhesive may be applied along the end 23 to seal the open end 18 of the tube 11 to the external surface of the tube 10. The white paper tape 30 is then applied over approximately half of the width of the polythene or polyvinylchloride tape 22. r[he entire package as thus assembled is exposed to gamma ray radiation to sterilize the catheter 12 and the tubes 1t) and 11. The packages are then ready for shipment to the utilizing medical facility.
The packages may be stored until such time as they are needed. To remove the catheter from the container, the portion of the tab 26 which is not wrapped underneath the tape 30 may be easily grasped by a thumb and forefinger and turned back as shown in FIG. 6 to tear the white paper tape 30. The green polythene or polyvinylchloride tape 22 may then be unwrapped from the tubes 1l) and 11 as illustrated in FIG. 7. Next, the tube 11 is removed from the tube 10 to expose the dual proximal end of the catheter 12. The dual proximal end of the catheter can then be grasped by forceps or lightly tapped or shaken to pull the catheter out onto a sterile surface without bringing the catheter even close to the contaminated exterior surface of the tube 10.
Once the seal vformed by the two tapes has been removed, it cannot be replaced upon the tubes to remake the seal without the tear in the white paper tape 30 being readily noticeable to even a casual observer. Thus, if the tab 26 has been pulled for any reason, beginning to open the seal and tearing the white tape 30 as shown in FIG. 6, it cannot be replaced without the fact of its having been partially opened coming to the attention of anyone who subsequently desires to use the catheter contained therein. Although the colors of the polythene or polyvinylchloride tape and the paper tape have been described as green and white, respectively, the colors of these tapes may be any pair of contrasting colors since the only requirement is that a tear in the paper tape stand out against the background of the polythene or polyvinylchloride tape.
1. A container comprising:
a first elongated plastic tube having an exterior surface,
a closed end and an open end,
a second plastic tube having a closed end and an open end and shaped to closely overlie a portion of the exterior surface of said first tube adjacent to the open end of said first tube,
a sealing tape having an adhesive side and sealing the open end of said second tube to the outer surface of said first tube by being wrapped around the open end of said `second tube and adhering to the surfaces of both tubes with a portion adjacent one end of said tape overlapping its other end, and
an indicating tape weaker than said sealing tape, ex-
tending across the overlapping end of said sealing tape, overlying only part of the width of said sealing tape, and having at least one exposed end.
2. A container as specified 4in claim 1, wherein said sealing tape and said indicating tape are contrasting in color.
3. A container having a tamper indicating seal comprising:
a first elongated plastic tube having an exterior surface,
a closed end and an open end,
a second plastic tube having a closed end and an open end and shaped to closely overlie a portion of the exterior surface of said rst tube adjacent to the open end of said first tube,
a sealing tape having an adhesive side and covering the open end of said second plastic tube and a portion of the exterior surface of said first plastic tube with a portion adjacent one end of said tape overlapping its other end,
a tab formed at the overlapping end of said sealing tape by having a short length of the tape adjacent the end folded. back upon itself with the adhesive side internal to the fold, and
an indicating tape weaker than said sealing tape, ex-
tending across the overlapping end of said se-aling tape, having at least one exposed end, and overlying only part of the width of said sealing tape whereby the indicating tape will be severed at the overlapping end` of said lsealing tape when the tape is removed from the container to visually indicate such removal if the sealing tape should again be used to seal a container.
4. A sterile Icontainer containing a catheter comprising:
a first elongated plastic tube having interior and exterior surfaces, a closed end and an open end, said interior surface being shorter in length than an enclosed catheter,
a second plastic tube having an interior surface, a closed end, and an open end and shaped to closely overlie a portion of the exterior surface of said first tube adjacent to the open end of said first tube to completely enclose the catheter,
projections protruding from the interior surface of said second plastic tube to limit the extent of the overlying of said first tube by said second tube whereby the combined length of the interior surface of said second tube which is prevented from overlying the first tube, and the interior length of said first tube are at least substantially equal to the length of the catheter,
a sealing tape having an adhesive side and sealing the open end of said second tube to the outer surface of said first tube by being wrapped over the open end of said second tube and adhering to a portion of both tubes with a portion adjacent one end of said tape overlapping its other end, and
an indicating tape weaker than said sealing tape, ex-
ten-ding across the overlapping end of said sealing tape, having at least one exposed end, and overlying only part of the width of said sealing tape, said sealing and indicating tapes being contrasting in color.
5. A tamper indicating container comprising:
a lcontainer having adjoining surfaces which lie adjacent to each other when the container is closed,
a sealing tape having an adhesive side which engages the adjoining surfaces to completely seal the container with a portion adjacent one end of said tape overlapping its other end, and
an indicating tape weaker than said sealing tape, eX-
tending across the overlapping end of said sealing tape, having at least one exposed end and` overlying only part of the width of said sealing tape in order that the indicating tape Will be severed at the overlapping end of the sealing tape when the sealing tape is removed from the container to visually indicate such removal if the sealing tape should again be used to seal a container.
6. A tamper indicating container as specified in claim 5 wherein said sealing and indicating tapes are contrasting in color.
References Cited by the Examiner UNITED STATES PATENTS 478,947 7/1892 Ames. 919,715 4/ 1909 Gray 229-93 922,435 5/ 1909 Lee. 1,265,932 5/1918 Maltby 229--93 1,659,399 2/1928 Fabel'. 1,918,109 7/1933 Joyce. 2,094,454 9/ 1937 Keville.
(Other references on following page) UNITED STATES PATENTS Drew 229-48 Bronander 229-51 Bell 229-51 Adams 206-59 Hickox 206-59 Druth 206-7 Langdon 20S-63.2 Rasmussen et a1 206-78 Koehn 206-63.2 X Stone'hill et a1 206-63.3
8 FOREIGN PATENTS 1,495,336 5/1924 Loomis. 2,680,515 6/1954 Lewis.
THERON E. CONDON, Primary Examiner.
1 EARLE J. DRUMMOND, FRANKLIN T. GARRETR GEORGE O. RALSTON, Examiners.