US 3138253 A
Description (OCR text may contain errors)
June 23, 1964 A. HARAUTUNEIAN 3,138,253
PACKAGED MEDICAL TRAYS Filed Dec. 27, 1960 United States Patent Pharmaseal Laboratories, Glendale, Calif, a corporation of California Filed Dec. 27, 1960 Ser. No. 73,497 Claims. (Cl. 206--63.2)
This invention relates to packaged medical trays, and particularly to sterile, disposable trays for use in catheterization procedures.
In the performance of various procedures, hospitals use sterile trays containing all of the desired equipment for performing the procedure. For example, such trays may be used for determining venous pressure, for making exchange transfusions, for making spinal taps, for surgical preparation, or for catheterization. Heretofore, these trays were usually made up by the hospital and after each use, the trays and equipment were cleaned, repacked and sterilized for subsequent use. Since many such procedures are performed in each large hospital, the cleaning, repacking and sterilizing operations take a great deal of time and labor. Handling contaminated equipment during cleaning operations is hazardous and unpleasant to hospital personnel. Re-use of the equipment may cause cross infection between patients, even when the equipment is carefully cleaned. Many hospitals are not equipped to accurately determine the costs of such work with the result that they may unknowingly be operating at a loss or overcharging the patient. Furthermore, the trays are completely impractical for home or oilice use.
It has been suggested that trays containing disposable equipment be assembled, wrapped and sterilized in factories where adequate precautions may be taken and tests may be made to assure cleanliness, sterility, and U proper function. Such trays would be discarded after a single use, thus eliminating the problems of cleaning and It is therefore an object of this invention to provide an improved sterile, disposable tray.
Another object of the invention is to provide a sterile, packaged, disposable tray for urethral catheterization which is compact and easy to ship and store.
A further object of the invention is to provide a packaged, commerdaily-manufactured, gas-sterilizable catheterization tray in an inexpensive package which will assure maintenance of sterility during shipping and storage.
A still further object of the invention is to provide a catheterization tray in a package which is easy to open in an aseptic manner andwhich allows convenient addition of antiseptic solution before use.
Further features and advantages of the invention will be apparent from the following specification and from the drawings, in which:
FIGURE 1 is an exploded view of the invention;
FIGURE 2 is a perspective view of the invention;
FIGURE 3 is a perspective view of the invention in an inverted or upside-down position; 7
FIGURE 4 is a sectional view on the line 4-4 of FIGURE 3; 7
FIGURE 5 is a perspective view similar to FIGURE 2, but after the package has been opened;
FIGURE 6 is a sectional viewon the line 6-6 of Patented June 23, 1964 trated in the drawings, a catheter tray 11 is enclosed by a cardboard tray or box 12, the sides and ends of which extend slightly. above the sides and ends of tray ll. A card 13, which may carry directions-for-use and other labeling, lies across the open top of tray 11. An overwrap 14, preferably of transparent plastic film, encloses box 12 and card 13, holding the card in place against the top of tray 11.
Tray 11 is preferably molded of a strong, rigid, impactresistant plastic material, such as polypropylene, linear (high density) polyethylene, or polystyrene, approximately 0.03 to 0.04 inch thick. Tray 11 preferably has a rectangular shape defined by side walls 16 and 17 and end walls 1% and 19. A bottom 2i) has ribs 21 and 22 which provide a flatsupport area for tray 11 and reinforce the tray against possible warping.
The top of tray 11 is open. The opening defined by.
the top surfaces of side walls 16, 17 and end walls 13, 19 is surrounded by an outwardly projecting fiange 23, from which extends a downwardly depending lip 24. A transverse dividing wall 3% extends across the container to define a main compartment 31. Compartment 31 preferably has a volume of 800 to 1000 cubic centimeters for adequate storage of urine obtained by the catheterization procedure. Graduations 32 are molded on the inner surface of side wall 16. A longitudinal dividing wall 33 extends from end wall 18 to transverse dividing wall 30, thus defining two small compartments 34 and 35.
As received by the hospital, main compartment 31 preferably contains a catheter 49, a packet 41 of lubricant, a fenestrated drape 42 and a protective undercover 43. Undercover 43 may be made of a laminate of absorbent paper with a waterproof plastic backing. In this way, the undercover can absorb small amounts of spilled liquid, while the waterproof backing prevents such liquids from soaking through to the bedding. Cotton or rayon balls 44 are placed in each of the compartments 3d and 35.
Card 13 is preferably made of cardboard and is slightly smaller than the open endof box 12. Thus card 13 lies across the top flange 23 of tray 11, and is held against 51 may be marked Lift Here to encourage the operator to bend the tab 51 along the scored line- St) to gain access to compartments 34 and 35.
Overwrap 14 is preferably made of a strong, transparent, plastic film such as a thin polyvinylchloride film or alaminate of polyethylene with cellophane. The film used should be permeable to sterilizing gases and strong enough to prevent formation of pinholes, punctures or ruptures after sterilization. Overwrap 14 is wrapped around box 12 so that oneedge extends longitudinally along the bottom of the box, providing an inner layer 5d (FIGURES 3 and 4). The other edge of overwrap 14 is then brought around box l2 to providean outer layer 54 overlapping inner layer 55. A longitudinal seal 53: is then formed along the length of the bottom of box 12, sealing outer layer 54 to inner layer 55. A portion of outer layer 54 extends beyond seal 53 to form a loose overlying flap '56. The ends of overwrap 14 are then folded in around the ends 66 and '67 of box 12 and the end s'eals'5'7, 53 formed.
As shown in FIGURE 7, box' 12 is preferably of the V foldup, corner tab lock type formed from a fiat cardboard sections 62, 63 separated from bottom section 61 by scored lines 64, 65. Blank 60 also has end sections 66 and 67, the latter being separated from bottom 61 by score line 63.
End section 67 has two flaps 69, 70 extending on opposite sides thereof. Each flap 69, 70 has a locking tab 71, 72 adapted to pass through and lock into the slits 73, 74 in side sections 62, 63, respectively, when the side and end sections are bent up along the scored lines to form box 12. The respective edges of side sections 62, 63 and of end sections 69, 70 define notches 75, 76 between said sections. End section 66 has similar flaps and locking tabs which are not shown in detail.
The blank structure thus far described has been used for many purposes. However, it is not suitable for sterile medical trays because the sharp corners of box 12 formed by the bottom and the respective side and end sections tend to puncture overwrap 14. The holes thus formed cannot be tolerated in a medical tray which must be kept sterile. I have found that this problem can be solved by extending the notches 75, 76 beyond the scored lines 64, 65 into a portion of the end section 67. This removes a portion of end section 67, thus forming small holes 79, 89 in each of the bottom corners of the assembled box 12. The corners thus formed by portions of bottom 61 and portions of the respective side sections 62, 63, fiex inwardly under pressure so that overwrap 14 is not punctured.
The packaged catheter tray described above can be sterilized with a gas, such as ethylene oxide or a mixture of ethylene oxide and an inert gas. This is generally done by placing the packaged trays in a pressure vessel and evacuating the vessel to a pressure of less than 15 cm. of mercury. Sterilizing gas is then admitted to the vessel to a total gauge of about three atmospheres. Steam is then injected into the vessel to adjust the temperature to about 90 to 140 F., and sterilization accomplished in 15 to hours. The sterilizing gases pass freely through gaspermeable overwrap 14 so that the entire contents of the package are sterile. At the end of the sterilization, the sterilizing vessel is vented and the pressure dropped to one atmosphere. Overwrap 14 maintains the package contents in sterile condition. I
In use, the tray is placed upside down, as shown in FIGURE 3, on a bench or table and the box 12 and inner overwrap layer 55 held with one hand. The overlying flap 56 is then raised and pulled back to easily open the longitudinal seal 53, Without contaminating catheter tray 11 or parts of box 12 or card 13 which may contact tray 11. The unit may then be turned over, as shown in FIG- URE 5, and the overwrap 14 pulled back to expose card 13.
Frequently, antiseptic solution is available at the nursing station, but not in the room where the catheterization procedure is to be performed. In this case, corner 52 of card 13 is raised, bending the card along the scored or weakened line 50. Antiseptic solution, such as a quaternary ammonium or iodophor solution is then poured directly onto the rayon balls 44 in the compartment 34. Since the scored line 50 is above the transverse wall or above compartments 34, near wall 30, antiseptic solution does not enter compartment 31 to contaminate urine samples which later may be drawn into the compartment. Card tab 51 is then bent down over compartments 34 and 35, closing them until the unit is to be used.
To carry out the catheten'zation procedure, box 12 is placed on a convenient table, and the top card removed. With sterile gloves, the operator then aseptically removes the protective undercover 43 from compartment 31 and positions it under the patient with the absorbent paper side up. Catheter tray 11 is then aseptically lifted by the dividing walls 30 and 33 and placed on the sterile undercover 43. The fenestrated drape 42 is then placed in position over the patient and lubricant squeezed from packet 41 onto a portion of undercover 43. Antiseptic solution is then applied by means of the rayon balls in compartment 34, through the opening in the fenestrated drape. Ex-
' stood that structural details of the invention may be varied by those skilled in the art, without departing from the spirit of my invention.
1. A sterile, packaged, medical tray comprising: a catheter tray having bottom, side, and end walls, each of said side and end walls terminating in a top edge lying in a substantially horizontal plane; an open top defined by the top edges of the respective side and end walls; a transverse wall connecting the two side walls and sep arating the tray into an antiseptic section near one end of said tray and a main compartment extending throughout the remaining portion of said tray, said transverse wall having a top edge lying substantially in the plane of the side and end wall top edges; removable antiseptic absorbent means in the antiseptic section of said tray; a flat card closing the open top of said tray, portions of said card resting on the respective top edges of the side and end walls, and the top edge of said transverse wall, but being free of attachment to said walls; a scored transverse line across said card, said scored line being parallel to the top edge of said transverse wall, being positioned over the antiseptic section and providing a weakened line of increased flexibility along which the card is easily bent so as to form a hinged tab over the antiseptic section, said tab allowing the antiseptic section to be selectively opened and closed without exposing said main compartment; and a film overwrap enclosing said tray and card, said film overwrap holding said card in place over said tray, being impervious to bacteria, and being provided with opening means at the end of the tray adjacent the antiseptic section, whereby the overwrap can be pulled back to expose the tab over said section while still holding the remaining portion of the card in place over the main tray compartment.
2. A sterile, packaged, medical tray as set forth in claim 1 wherein said overwrap has an overlapped section lying lengthwise along the bottom of the tray; a longitudinal seal along the inner edge of the overlapped section; and a loose portion of the overlapped section lying outwardly of the seal.
3. A sterile, packaged medical tray as set forth in claim 1 wherein the catheter tray is positioned in a cardboard box and said overwrap is applied around said tray and said box, said box being of the corner tab lock type having a bottom and sides and end walls, at least one corner formed by adjacent portions of the bottom and the respective side wall, the end and side having a small undercut V-shaped notch at the intersecting corner of the side, end, and bottom of said box to relieve the sharp corner without creating a large hole through the box through which the overwrap could be punctured, said notch appearing on the end member when the box is in its erected state; and a locking tab on the end wall to fold up and engage a notch within a corresponding side wall.
4. A sterile, packaged, medical tray comprising: a plastic tray having bottom, side, and end walls, each of said side and end walls terminating in a top edge to provide an open top; sterile, disposable, medical instruments and equipment positioned in said tray; a fold-up, corner tab lock-type box in which the tray is positioned, said box having a bottom, side and end walls, and at least one corner formed by a portion of the bottom and of the respective side walls; a flat card closing the open top of said tray, portions of said card resting on the respective top edges of the side and end walls of the tray; a film-like overwrap pervious to sterilizing gases but impervious to bacteria enclosing said box and card; and a small V-shaped notch formed by the adjacent end and side sections at each bottom corner of the box, said notch appearing on the end member of the box, extending into said end member and providing a softened, dulled bottom corner, the film-like overwrap thus being supported by the side, end and bottom walls of the box and by the card, but being unsupported at the small notched bottom corner whereby puncture of the overwrap by the sharp corner usually present in corner tab lock-type boxes is prevented.
5. A sterile, packaged medical tray comprising: a molded, plastic catheterization tray having side and end walls, a bottom wall and an open top; a transverse wall dividing said tray into a main compartment, said main compartment having graduations on the inner wall surface thereof, and an antiseptic section, a partition between said transverse wall and the end of said tray separating said antiseptic section into two antiseptic compartments, the two antiseptic compartments containing absorbent means for liquid antiseptic, a flange projecting outwardly from the tray walls around the open top to provide a flat top surface; a flat card lying across said top surface and closing the open top of the tray; said flat card having a score line laterally across it at a position parallel to but a slight distance from the transverse wall so as to place the score line over the antiseptic section, said score line providing a flexible hinge enabling said antiseptic compartments to be selectively opened and closed without opening said main compartment; a cardboard box enclosing the tray and having side and end walls extending slightly above the tray walls; a bottom on said box; a film-like overwrap around the box and References Cited in the file of this patent UNITED STATES PATENTS 1,644,830 Henderson Oct. 11, 1927 1,680,804 Remley Aug. 14, 1928 1,907,067 Hartmann May 2, 1933 1,992,098 Sidway Feb. 19, 1935 2,055,333 Burke Sept. 22, 1936 2,138,241 Koch Nov. 29, 1938 2,295,478 Jason Sept. 8, 1942 2,366,419 Meller Jan. 2, 1945' 2,471,861 Cahn May 31, 1949 2,934,252 Wickstrom Apr. 26, 1960 2,965,501 Harriss Dec. 20, 1960 2,967,383 Rumsey Jan. 10, 1961 2,990,948 Zackheim July 4, 1961 3,037,680 Hickin June 5, 1962 3,043,354 Fitzgerald July 10, 1962 3,059,829 Thompson Oct. 23, 196% 3,062,371 Patience Nov. 6,