US 3783996 A
A three-piece syringe package which, when separated, is adapted to contain a fluid for performing an irrigation procedure. The package has a tubular base portion and a tubular cap portion separated by a tubular collar, the latter having a central opening receiving the syringe. A sealing tape joins the base, cap and collar such that the interior of the package may be sterilized as a completed unit.
Claims available in
Description (OCR text may contain errors)
United States Patent Gerard et al. Jan. 8, 1974 SYRINGE PACKAGE 2,492,326 12/1949 sc6m....; 206 175 1 3,485,239 12 1969 Vanderbeck 206/43 [751 Invent: Wuhan fi Overland; 3,235,069 2/1966 Bennett et al 206/632 R D. Ruck, St. Louis, both of Mo.
 Assignee: Sherwood Medical Industries Inc., Primary ExaminerWilliam T. Dixson, Jr.
St. Louis, Mo. Attorney-Stanley N. Garber et al.
 Filed: Mar. 14, 1972 21 Appl. No.: 234,560  ABSTRACT A three-piece syringe package which, when separated, 52 US. Cl 206/175, 206/43, 206/632 R is adapted to contain a fluid for Perfmming irriga- 51 1111. c1 B656 5/50, B65d 85/00 Procedure The Package has a tubular base P  Field 61 Search 206/175, 16.5, 16.6, and a tubular Cap Portion Separated by a tubular 206/43 69, 632 R collar, the latter having a central opening receiving the syringe. A sealing tapejoins the base, cap and col-  References Cited lar such that the interior of the package may be steril- UNITED STATES PATENTS ized a mpleted 3,696,916 10/1972 Penniman et 61..., 206/l6.6 5 Claims, 5 Drawin Figures PATENTEUJAR 8 m4 3783996 sum 10; 2
SYRINGE PACKAGE BACKGROUND OF THE INVENTION This invention relates to medical packages, and more particularly to a combination syringe package and liquid container.
Many techniques have been devised for the irrigation of a human bladder or wound. For example, an irrigation procedure may be necessary whenever a foley catheter is inserted into the body. Irrigation is primarily used to cleanse the bladder and to maintain the catheter drainage lumen unobstructed. Irrigation is also used, for example, to remove clots after a prostatectomy procedure or after a transurethral resection, and for other urological surgical procedures. The most commonly used irrigation fluid is physiological saline, a salt solution, since it closely approximates natural body fluids.
In the past, the only packaged equipment avaiable to carry out the above procedures was a conventional plastic tray containing a syringe with a plastic or paper lid thereon. While this type of package has generally served the purpose, it has many disadvantages which lead to increased costs, decreased efficiency and possible loss of sterility and contamination. For example, this type of package does not provide for removal of the components in their order of use and therefore increases handling and the chances of contamination. Additionally, such equipment is usually not complete, requiring the addition of fluid reservoirs for the irrigation and drainage liquids.
SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a combination syringe package and liquid reservoir, and more particularly a syringe package for use in medical irrigation procedures.
It is a further object of the invention to provide such a syringe package which eliminates the above noted disadvantages, which serves as both a protective package for a syringe and as a liquid reservoir when conducting an irrigation procedure, which protects the sterility of the components of the package against contamination and is tamper proof, which is easily and selectively opened in either of several configurations, which permits sterilization of the completed package, and which is characterized by simplicity of construction, low cost and ease of operation in use.
In general, a syringe package constructed in accordance with the present invention comprises a tubular base portion having a closed end and an open end and a tubular cap portion also having a closed end and an open end. A collar is provided for receiving the open ends of the base and cap, the collar having an axial opening for holding a syringe centrally in the base and cap. Passage means tend from the exterior of the package to its interior for the passage ofa sterilizing gas into the interior of the base and cap, and means are provided for detachably joining the base, cap and collar to form a relatively rigid packageOther objects and features will be in part apparent and in part pointed out hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the present syringe package in completed, assembled condition.
DESCRIPTION OF TI-IEPREFERRED EMBODIMENT THE PREFERRED Referring nowto the drawings, and particularly to FIGS. 1 and 2, the present syringe package is shown at 10 as comprising a cylindrical or tubular base portion 12, a cylindrical or tubular cap portion 14 and a tubular collar portion 16 intermediate the base and cap. A sealing tape or closure 18 rigly secures the base and cap to the collar to form a unitary package, as will be more fully described hereinafter. As viewed in FIGS. 2 and 4, the tubular collar portion 16 has an axial opening 20 therein for holding a syringe, such as bulb syringe 22, centrally in the base 12 and cap 14. The base 12 more specifically comprises a tubular wall 24, a closed lower end 26 and an open upper end 28. The closed lower end 26 of the base may be slightly concave so as to pro vide a dished interior surface so that any liquid therein will collect at its center adjacent the distal tip of the syringe, and is provided on the exterior thereof with plural protuberances or feet 30 for level suport of the base. The base 12 may be conveniently provided with calibration marks 32, for example, either in fluid ounces or cubic centimeters, or both, for indicating the quantity of irrigating liquid contained therein. The cap 14 is similarly formed of a tubular wall portion 34 having a closed upper end 36 and an open lower end 38. The interior diameter of the tubular wall portion 34 ofthe cap is slightly larger than the interior diameter of the tubular wall portion 24 of the base as will be described more fully hereinafter.
The collar 16 is comprised of upper and lower tubular wall portions 40 and 42, respectivy, separated medially by a plurality of laterally extending lugs or projections 44 spaced by recesses 45 forming upper and lower shoulders 46 and 48 for respectively receiving the open lower end 38 of the cap and the open upper end 28 of the base. The upper tubular wall portion 40 of the collar 16 has an inturned flange 50 integral therewith having a depressed central section 52 with the axial opening 20 therein. In addition, the upper tubular wall portion 40 is provided with peripherally spaced ribs 54 intermediate each of the lugs 44; As is illustrated in FIGS. 4 and 5, the axial opening 20 in the upper surface of the collar is provided with four semi-circular notches 56 around the periphery thereof for the passage of a sterilizing gas. The collar is additionally provided with four web members 58 on its interior for adding rigidity to the collar, each of the web members having a face 60 extending parallel to the axis of the package. These faces engage the syringe when in the collar to retain the syringe in a generally vertical position centrally located within the base and cap. That is, engagement of the faces 60 of web members 58 along the exterior surface of the syringe barrel prevents the syringe from tipping within the container so as to avoid contacting the side walls of the base. I
As will be noted in FIG. 2, the syringe illustrated is of the bulb type, that is comprising a plastic syringe barrel 62 terminating in a distal tapering tip 64, with a rubber or plastic squeeze bulb 66 fitted in the bore of the syringe barrel at its proximal end. While a bulb syringe is illustrated for use with present syringe package, it should be understood that a conventional piston syringe may also be utilized with the present package without alteration thereof.
The closure tape 18 joins the base and cap to the collar section so as to form a unitary, rigid package assembly having a tortuous passageway extending from its exterior to its interior. In addition, however, the tape must also permit sterilizing gas to enter into the interior of the package so as to sterilize the package at the completion of its assembly but prior to shipment to the customer. In this regard it should be noted that the adhesive coating on most tapes acts as a barrier for the passage of sterilizing gas. Thus, as illustrated in FIG. 1, the tape is folded diagonally at one end, as indicated at 68, so as to provide an unsealed portion for the entry of the sterilizing gas. Since the end portion 68, which is foled over on itself, will not have an adhesive portion adhering the tape to the exterior of the syringe package, sterilizing gas may enter the container at the margins of the tape along this unsealed portion. The sterilizing gas, as indicated by arrows 70 in FIGS. 1 and 3, enters at the end portion 68 of the tape 18, passes between the lugs 44 on the collar 16, and flows between the ribs 54 on the upper tubular surface of the collar between the surface of the collar and the interior surface of the cap and into the interior of the cap portion 14 of the package. In this regard, it should be noted that the ribs 54 are provided for spacing the enlarged diameter interior surface of the cap from the exterior upper surface 40 of the collar to permit passage of the sterilizing gas to the interior of the cap. From the interior of the cap, the sterilizing gas then passes downwardly through the semicircular notches 56 around the axial opening 20 in the collar between the syringe barrel 62 and the opening 20 and downwardly into the interior of the base portion 12 of the package. In this manner, the entire interior of the syringe package is subjected to the sterilizing gas, for example ethylene oxide, and is thereby sterilized, eliminating the necessity of sterilization of the individual components of the package prior to assembly, together with the necessary sterile assembly of the package. The tape 18 may be formed of any suitable plastic or paper material having a pressure sensitive or heat activated adhesive coated on the interior thereof. In addition, the fit between the base/collar and cap/collar may each vary from zero interference to a tight fit so that either joint will normally release first when opening the package.
While the tape has been illustrated as having a folded end portion for initial entry of the sterilizing gas, it should be understood that other methods may be applicable for entry of the gas into the interior of the package. For example, the tape may be strip coated with an adhesive, that is coated only along its edges and uncoated in the center, or selectively coated in a crosshatched or other pattern, rather than coated over its entire surface, so that the gas can enter through the paper or plastic tape between the adhesive coated areas.
As illustrated in FIG. 1, a permanent indicator tape 72 is applied across the end portion of sealing tape 18 so that, when the sealing tape is initially removed from the package to separate the components thereof, the indicator tape 72 is torn by the sealing tape 18 so as to positively indicate that the package has been opened. Without an indicating tape or a heat activated closure tape, it may be possible to reassemble the components of the present syringe package and replace the sealing tape in such a manner that it would be difficult to determine whether the package had been previously opened and whether its contents are sterile.
Once opened, the components of the package may be disposed as illustrated in FIG. 5 such that the base and cap portions 12 and 14, respectively, may be used as fluid reservoirs, as indicated by liquid 74, and the collar portion 16 supports the syringe 22 in a sterile manner, that is with the distal tip 64 spaced from the supporting surface.
A typical procedure for use of the present invention will now be described with regard to a catherized human bladder for irrigation thereof.
The disassemble the syringe package 10, the end 68 of the sealing tape 18 is grasped by the user and peeled away from the surface of the package. In so doing, the indicator tape 72 is torn providing a tamper proofindication of opening of the package, thereby warning subsequent users of the lack of sterility of its contents. After the sealing tape 18 has been completely peeled away from the surface of the package, the sealing tape is discarded. With the base 12 of the package standing on a support surface, such as a table top, the package is separated at the collar/base interface by grasping the collar with one hand, the base with the other and pulling in opposite directions. The cap, collar and syringe may then be inverted and placed with its closed upper end 36 downwardly on the top of the table so as to permit filling of the base portion 12 with a suitable irrigation solution. Alternatively, the package may be separated at the cap/collar interface by grasping the cap with one hand and the collar and base with the other hand and separating at this juncture. After the cap has been inverted and placed on the table, the collar 16 containing the syringe 22 may be separated from the base and placed on the table in the position indicated in FIG. 5 such that the bulb portion of the syringe and the collar support this assembly with the syringe tip spaced from the surface of the table. Again, the base is then filled with a suitable irrigation solution.
If the cap and collar have previously been removed as a unitary assembly, after filling of the base portion with the irrigation solution, the cap and collar are returned to their original position whereby the collar, cap and syringe are again seated on the base. This is then followed by removal of the cap at the cap/collar interface and inversion of the cap for placement on the table. A drainage tube from a catheter (not shown) is then inserted into the inverted cap portion for drainage purposes and the syringe is filled in a conventional manner with the solution in the base portion. After filling of the syringe, it is removed from the collar and connected to the irrigation lumen of the catheter for injection of the solution into the bladder in a conventional manner. This is repeated as often as required, with the drainage fluid returning through the catheter to the cap portion. Since the collar 16 holds the distal tip 64 of the syringe 22 closely adjacent the lower end 26 of the base 12, substantially all fluid contained therein may be removed by aspirating the syringe. After the irrigation procedure has been completed, the entire unit may either be discarded or emptied and cleaned and resterilized, as by autoclaving, for use again. It should be understood that other components may be contained within the package depending upon the particular medical procedure for which the package is designed.
In view of the above, it will be seen that the several objects of the invention are achieved and other advantageous results obtained.
As various changes could be made in the above construction without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
1. A syringe package comprising a base member having a closed end and an open end, a cap member having a closed end and an open end, a collar having an axial opening for receiving the barrel of a syringe to hold a syringe centrally in said base and cap members, said collar having an end portion telescopically receiving one of said members with a radial space between telescoping portions thereof which connects with the interior of said one member, an opposite collar end portion telescopically receiving the open end of the other of said members, and an intermediate laterally outwardly extending collar portion defining opposed shoulders engageable respectively with the open ends of said base and cap members to space the open ends thereof apart, closure means secured to said base and cap members and said collar for detachably joining them to form a relatively rigid package, said intermediate collar portion having at least one axially extending recess in the periphery thereof providing a gas path connected with said radial space, said closure means permitting the flow of sterilizing gas from the exterior of the package into said recess so that sterilizing gas passes through said recess and said radial space and into the interior of said one member of the package.
2. The syringe package as set forth in claim 1 wherein said intermediate collar portion has an axial passage therethrough within the interior of the package to pass sterilizing gas from the interior of said one member to the interior of said other member.
3. The syringe package as set forth in claim 1 wherein said closure means includes sealing tape having an adhesive coating thereon, said tape extends around said intermediate collar portion with portions of said tape adhering to said base and cap members.
4. The syringe package as set forth in claim 3 wherein said intermediate collar portion includes a plurality of axially extending recesses in the periphery thereof connected with the interior of said one member and defining plural spaced lugs around said intermediate collar portion.
5. The syringe package as set forth in claim 3 further including spacing means between said telescoping portions of said collar and said one member to radially space the same apart.
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