US 3780857 A
A sterilizable sealed plastic sheet or film package containing a folded sheet of material adapted to form a sterile field when unfolded, said sheet being reinforced in a limited area by means of an attached relatively stiff sterilizable piece of cardboard, and said package also containing optionally, one or more instruments.
Claims available in
Description (OCR text may contain errors)
United States Patent [1 1 Rosano, Jr. et al.
[ Dec. 25, 1973 INSTRUMENT PACKAGE WITH STERILE FIELD  Inventors: Joseph G Rosano, Jr., Roselle Park; Vincent L. Vaillancourt, Livingston,
both of NJ.
 Assignee: C. R. Band, Inc., Murray Hill, NJ.
 Filed: Dec. 30, 1971  Appl. No.: 214,338
 US. Cl. 206/632  Int. Cl A6lb 19/02  Field of Search 206/632 R, 46 SG,
206/46 BL; 229/87 R, 87 S  References Cited UNITED STATES PATENTS Overment 206/632 R Huyck et al 206/632 R UX 211,403 1/1879 Hope, 229/87 R 1,062,150 5/1913 Goodman 229/87 S 203,427 5/1878 Daul 229/87 R 3,338,400 8/1967 Edgworth et al 206/632 R 2,980,245 4/1961 Stoker 206/632 R UX 3,595,465 7/1971 Vaillancourt 206/632 R X FOREIGN PATENTS OR APPLICATIONS 1,205,011 9/1970 Great Britain 229/87 R Primary Examiner-Leonard Summer Attorney-W. Saxton Seward and Chester E. Martine  ABSTRACT A sterilizable sealed plastic sheet or film package containing a folded sheet of material adapted to form a sterile field when unfolded, said sheet being reinforced in a limited area by means of an attached relatively stiff sterilizable piece of cardboard, and said package also containing optionally, one or more instruments.
6 Claims, 13 Drawing Figures PAIENIEQUEBZS I975 SHEUBBF3 PAIENIED 3.780.857
am! 3 0f 3 FIG. 10
INSTRUMENT PACKAGE WITH STERILE FIELD According to current medical and surgical practice it is customary to place one or more instruments on a stainless steel tray, (constituting a rigid base) and then to wrap the tray and its contents in a sheet of CSR wrap (CSR standing for central supply room) which may be muslin or Dennison" wrap or some other suitable woven or non-woven material, the wrapping being effected in such a manner that the package can be opened and placed in position for use without touching the uppersurface. After wrapping, the package is sterilized and may be stored a short or longer time before use. When needed, the package is opened up in such a way that the inside surface of the wrap forms an upper sterile 'field on which rest the tray and instruments. According to the present invention the expensive stainless steel tray is replaced by a piece of cardboard, attached to the wrap, and both are sealed within a sterilizable sealed package, with or without instruments, the package being adapted to maintain the sterility of its contents for an extended period of time. The wrap material is preferably so folded on the cardborad that it can be fully opened by pulling apart two corners or tabs, without the possibility of contaminating any substantial portion of the field area.
A practical embodiment of the invention is shown in the accompanying drawings, wherein:
FIG. 1 represents a projection of the complete package and contents prior to sealing;
FIG. 2 represents a projection of the sterile field element, completely folded;
FIGS. 3,4, and 5 represent similar views of the sterile field in successive stages of unfolding, and
FIG. 6 represents a similar view of the sterile field completely unfolded and ready for use.
FIG. 7 represents a projection of an alternative form of sterile field element, completely folded;
FIGS. 8 and 9 represent projections of the element of FIG. 2, in partially and completely unfolded positions;
FIG. 10 represents a projection of another alternative form of sterile field, completely folded;
FIG. 11 represents a projection of the element of FIG. 10 in unfolded position; and
FIGS. 12 and 13 represent projections of another alternative form of sterile field element, in folded (rolled) and unfolded (unrolled) positions, respectively.
Referring to the drawings, the wrap 10 is shown as being a rectangular (e.g., square) piece of non-woven material of the type commonly used, such as DennisonWrap," Confil, Vigilon" wrap or cellulose wadding, in a single layer or laminated. A square piece of cardboard constituting a mat 11 is adhesively secured to the middle of the wrap 18, preferably with the corners of the mat opposite the straight sides of the wrap, i.e., with the diagonals of the mat forming angles of 45 with the diagonals of the wrap. In order to effect the type of folding shown in the drawings, the sides of the wrap should be somewhat more than twice as long as the sides of the mat, a suitable relation being 16 inches X 16 inches for the wrap and 7 inches x 7 inches for the mat.
With the mat affixed to the wrap as shown in FIG. 6 the wrap is folded inward along the lines l2, l3 corresponding to opposite side edges of the mat, and each triangular folded portion l4, is then folded outwardly along lines l6, 17 corresponding to a middle line of the mat. The upper surface of the mat is thus covered, as shown in FIG. 4 and the corners 18, 19 of the wrap project laterally outward beyond the fold lines l2, 13, because of the relative dimensions of the mat and wrap.
From the positions shown in FIG. 4 the oppositely projecting comers of the wrap are folded inward along the lines 20, 21, corresponding to opposite edges of the mat, and are then folded outwardly along lines 22,23 corresponding to the middle line of the mat, as shown in FIGS. 3 and 2, leaving the comers 24, 25 projecting laterally beyond the fold lines 20,21.
The folded field constituted by the mat and wrap is designed to be enclosed within a pouch 30 made of such materials, for example, as the plastic and paper combination described in Vaillancourt U.S. Pat. No. 3,595,465, July 27, 1971, the pouch being formed preferably with gussetted sides (as indicated at 31) to increase its capacity. It is frequently desirable to enclose one or more surgical instruments in the pouch with the field; when the desired contents have been inserted, the open end 32 of the pouch is heat sealed, the package is sterilized in any suitable manner, as by gas (ETO) or autoclaving, and the sealed sterlized package is stored until needed.
In use, the package is opened, by peeling or cutting, and the folded field is carefully removed by grasping only surfaces which are or will be under surfaces. The corners or tabs 24, 25 are pulled apart, opening the wrap from the position of FIG. 2 to that of FIG. 4, and the corners or tabs 18, 19 are similarly pulled apart to open the wrap completely as shown in FIG. 6. The sterile instruments 33, if any, may be placed on the mat 11 where they are surrounded by a field which is untouched and sterile except at the extreme corners l8, 19, 24, 25.
The alternative form of sterile field shown in FIGS. 7, 8 and 9 comprises a sheet of non-woven material 35 which is substantially square, with an integral flap 36 extending outward from one edge, the flap being bounded by an edge 37 which is a continuation of the edge 38 of the square area, and by a parallel edge 39 which is a continuation of the median fold line 40 of the square area. A rectangular piece of carboard 41 is secured to and covers the flap 36, the cardboard desirably having an extension 42 projecting beyond the end of the flap and being scored along the line 43 (adjacent said end) to permit folding of the cardboard, if desired. The cardboard may also have one or more small pockets 44 attached to its surface to receive instruments, and one or more instruments may be attached to the extension 42 in any suitable manner.
In preparing the field element of FIGS. 7-9 for packaging, the square area is folded on the median line 40 (from the extended position of FIG. 9 to the position of FIG. 8) and the double-thickness rectangular strip thus formed is then folded on the transverse lines 45 (near an edge of the cardboard) and 46 (approximately midway of the rectangular strip) so that the cardboard 41 is completely covered by four layers of the material 35, as shown in FIG. 7. The extension 42 and material overlying it can also be folded along the line 43, if desired, and the assembled field (with instruments, if any) may be sealed within a pouch, such as the pouch 30, for sterilization, storage and eventual use.
In use, the packaging steps are reversed, the folded material 35 being pulled out first to the position shown in FIG. 8 and then unfolded completely, as shown in FIG. 9, wherein all the exposed upper surface is untouched and sterile.
The field element of FIGS. 10 and 11 comprises an elongated strip of sheet material 48 having its middle portion 49 secured to the upper surface of a square or rectangular sheet of cardboard 40. Each projecting end portion 51 of the strip has a length approximately equal to the dimension in a corresponding direction of the cardboard, each end portion being folded inward at the edge of the cardboard to overlie half of the portion 49 and folded outward from the midline of said portion to form a double layer with the free edges of ends 51 at the opposite edges of the cardboard.
in FIGS. 12 and 13 the sterile field element is shown as comprising a rectangular (e.g., square) cardboard mat 55 and an elongated strip 56 of non-woven and/r laminated sheet material having one end secured, as by an adhesive along one edge of the cardboard mat as shown at 57. For packaging, the strip 56 is rolled up from its free end toward the mat and the field element is sealed in a pouch, such as the pouch 30, sterilized and stored until needed. When the field element is removed from the pouch, it. can be unrolled merely by holding a free corner of the cardboard and oscillating the edge to which the strip is secured, causing the strip to unroll by gravity. The inside surface of the strip becomes the upper surface of an elongated sterile field which includes also the surface of the cardboard mat (only a corner of which has been touched).
The sterile sealed packages just described have a shelf life several times that of unsealed muslin and/or non-woven wrapped packages, while being adapted to provide a firm support for instruments at a low cost and with complete disposability.
The mats are described as being cardboard because that material can be obtained in coated form, to prevent absorption of steam during autoclaving and thus eliminate weeping thereafter; it can also withstand autoclaving without warping, and it is relatively inexpensive. Plastics in the lower cost range are subject to warping, while autoclavable plastics are much more expensive, except for polypropylene which could be used if desired.
It will be understood that various changes may be made in the form, construction and arrangement of the several parts without deparing from the spirit and scope of the invention and hence I do not intend to be limited to the details shown or described herein except as the same are included in the claims or may be required by disclosures of the prior art.
1. A package assembly comprising a sealed sterilizable pouch made at least in part of plastic sheet material, and an instrument field element contained in said pouch, said field having a flat stiff portion and a flexible sheet portion secured to said stiff portion, said sheet portion having an area greater than the area of said stiff portion and being so located that at least part of the surface of the sheet portion designed to be the upper surface of the field is covered by other parts of the sheet portion and at least a part of the stiff portion is also covered by the sheet portion, the stifi portion being rectangular, the sheet portion including a flap having a width substantially equal to the length of one edge of the stiff portion, and said portions being secured together adjacent said one edge, the length of said sheet portion including said flap being greater than the dimension of the stiff portion normal to said one edge.
2. A package according to claim 1 wherein the folded portion covers all of the upper surface of the stiff portion.
3. A package according to claim 1 wherein the stiff portion is coated cardboard and the sheet portion includes a non-woven fabric.
4. A package according to claim 1 wherein the sheet portion includes a substantially square enlarged area folded on a line forming an extension of a second edge of the stiff portion whereby said area, when folded, constitutes an elongated two-layer strip, and said strip having a length such that it covers all of the upper surface of the stiff portion.
5. A package according to claim 1 wherein the stiff portion is scored on a line spaced from and parallel to said one edge.
6. A package according to claim 1 which includes means on said stiff portion for removably retaining one or more instruments.
UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No. 3, 780, 857 Dated December 25, 1973 Inventor(s) Joseph G. Rosano, Jr. and Vincent L. Vaillancourt It is certified that error appears in the above-identified patent and that said Letters Patent are hereby corrected as shown below:
In the heading, Assignee: "C. R. Band, Inc., Murray Hill, N. J."
should read c. R. Bard, Inc., Murray Hill, NJ.
Signed and sealed this Qth day of April 1 1;
EDWARD M.FLETCHER,JR C. MARSHALL DANN Attesting Officer Commissioner of Patents I FORM PO-105O (10-69) UsCOMM-DC 60376-P69 a: u.s. GOVERNMENT PRINTING OFFICE ms 0-866-334