US 3487917 A
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NEEDLE SUTURE PACKAGE Filed Dec, 21, 196'? INVENTOR WILLIAM H. SHAVE LEONARD D. KURTZ ATTORNEYS United States Patent O 3,487,917 NEEDLE SUTURE PACKAGE William H. Shave, Roosevelt, and Leonard D. Kurtz, Woodmere, N.Y., assignors to Deknatel, Incorporated, Queens Village, NY.
Filed Dec. 21, 1967, Ser. No. 692,567 Int. Cl. A61l17/02;B65d /42, 33/16 US. Cl. 206-633 Claims ABSTRACT OF THE DISCLOSURE A package for a needled suture of surgical gut including a main section and a cover layer having an end flap. When the package is assembled the end flap is folded underneath the main section and the upper and lower edges of the package are crimped. The package material is multi-layered and includes an absorbent layer for retaining liquid adjacent the surgical gut and a sealing layer of metallic foil.
FIELD OF THE INVENTION The present invention relates to surgical packages and more particularly to an improved surgical package providing considerable resistance to drying out of the surgical gut.
BACKGROUND OF THE INVENTION AND THE PRIOR ART In our co-pending application Ser. No. 584,731, now US. Patent 3,363,751, granted Jan. 16, 1968, there is disclosed an improved needle surgical package wherein foldable side panels enclose or imprison, first, a surgical suture arranged in a linear zig-zag configuration and, secondly, the attached suture needle, in alternate layers formed by the panels. This packaging arrangement provides efficient and expeditious handling of the suture and particularly provides for rapid and efficient removal of the suture from the package at the time of use. This avoids the necessity of opening multiple packages and laying out many sutures prior to use. Normally surgical sutures are packaged in an inner and outer envelope. The inner envelope contains the tubing fluid which retains the suture in a moist, usable condition. However, under present practice it is necessary for the surgical nurse to open a number of envelopes and lay out a number of the surgical gut sutures on a towel sometime prior to use. Thus the gut is exposed and subject to drying out for a period of time prior to actual use.
The package of US. Patent 3,147,861, invented by one of the co-inventors here, may be referred to for an example of a prior arrangement used in packaging sutures employing surgical gut.
BRIEF SUMMARY OF THE INVENTION The present invention provides a package specifically designed for sutures of surgical gut which enables the surgical gut to be retained in a moist usable condition in the operating room and has ready removal features similar to those of the package disclosed in our prior application.
In accordance with one feature of the present invention the package forms a sealed container for a tubing fluid such as a mixture of alcohol and water which serves to decrease the evaporation rate of the fluid and thereby increase the time of evaporation. In accordance with another feature of the present invention the package material includes an absorbent layer which serves as a reservoir for the tubing fluid and thereby increases the amount of time necessary for drying.
3,487,917. Patented Jan. 6, 1970 "ice In accordance with a presently preferred embodiment the suture is disposed on a base or central portion of a laminated sheet and the side panels are folded thereover with the needle disposed between the two folded side panels as disclosed in our prior application. One side panel has an end panel or flap formed thereon which is folded around the bottom surface of the base or central panel. The ends of the package are then crimped so that tubing fluid used in keeping the surgical gut moist is completely sealed within the package. By using a crimping operation to seal the package the package may be readily opened by a nurse at the time the surgical gut is to be used and the gut may be removed from the pack age in the same manner as disclosed in our prior application. The package material preferably includes an inner layer of absorbent material which surrounds the surgical gut and thus forms a reservoir for retaining the tubing fluid.
Thus a package is provided for surgical gut which eliminates the wastage and inefficiency attendant with the use of prior art packages. The package is opened immediately before use so that there is no drying out of the gut. It is only necessary to open the exact number of suture packages which are to be used so that there is no wastage. By utilizing an absorbent inner layer there is no danger of spillage of the fluid maintaining the gut in a moist state when the package is opened as there will be substantially no free fluid in the package under these circumstances. In this regard and in accordance with a further feature of the invention the surgical gut and/or the absorbent inner layer may be pre-soaked to a condition of maximum absorption such that evaporation.
and spilling is combatted.
BRIEF DESCRIPTION OF THE DRAWINGS Other features and advantages of the present invention will be apparent upon consideration of the following detailed description of a preferred embodiment of the invention taken with the accompanying drawings wherein:
FIGURES l-4 illustrate various steps followed in forming a packaged suture in accordance with the invention, FIGURE 3 being partially cut away to show a portion of the suture needle;
FIGURE 5 illustrates a step in the removal of the suture from the package by a user; and
FIGURE 6 is an enlarged section view taken along line 6-6 of FIGURE 1 showing the construction of the packaging material.
DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGURES 1-4, the suture package of the present invention is formed from a rectangular sheet of material denoted 10 which is folded along a first longitudinal fold line 11 a second longitudinal fold line 12 and a third longitudinal fold line 13 to form a main section B, a first side panel A, a second side panel C and an end panel D. A needle suture 20- having a first end 22 and a needle end 21 is disposed on the meain section B of sheet 10 between fold lines 11 and 12 starting from the first end 22 and continuing in a zig-zag manner such that each longitudinal linear portion of the suture 20 lies adjacent and parallel to the previous line as shown in FIGURE 1. The zig-zag placement of the suture 20- extend across the main section B and the end of the suture having needle 21 attached extends beyond the edge of the main section as shown in FIGURE 1.
Side panel A is folded about fold line 11 to cover and enclose or capture the linear zig-zag arrangement of suture 20 as shown in FIGURE 2. With panel A so folded, the end portion of suture 20 including needle 21 is bent about 3 the lower edge of panel A as shown in FIGURE 2 so that it lies above panel A.
In the next step, side panel C is folded about fold line 12 thereby enclosing needle 21 between panels A and C as shown in FIGURE 3. Panel C is shown partially cut away to show a portion of the needle 21 with the remainder of the needle 21 being shown in dotted lines in FIGURE 3.
To complete the folding of the package, end panel D is folded about fold line 13 downwardly (FIGURE 3) and around the right-hand edges of panels C, A and B as seen in FIGURE 4 to a position beneath main section B. In accordance with an important feature of the present invention the upper and lower edges of the package so formed are crimped as indicated at crimp lines 24 and 25 of FIGURE 4.
To utilize the packaged suture 20, the package may be held as shown in FIGURE 5. The left hand 26 shown in FIGURE 5 may be that of a nurse presenting the package to the surgeon; and the right hand 28 may be that of the surgeon removing the suture directly from the package 10 for immediate use. The nurse may expose the needle by lifting the flap formed by panels C and D and the surgeon may then simply grasp the needle 21 and pull to free the suture. As is set forth in our previous application the overall arrangement of the package and particularly the linear zig-zag arrangement of the main portion of the suture permit the suture to be removed rapidly and in a condition completely free from tangles.
In accordance with our earlier filed application discussed above, the outer longitudinal edge of panel C would extend to a position short of the right-hand edge of the package formed along fold line 12, a position indicated by dotted line C in FIGURE 3. The provision of overlapping end panel D of the present invention serves a number of purposes. First, the overlapping panel D provides a more secure enclosure for needle 21 in that in the prior construction the upper flap formed by panel C would have a tendency to open. Coupled with the endcrirnping provided by crimp lines 24 and 25, overlapping panel D provides secure imprisonment of needle 21.
It will be appreciated that the package of the invention is easier to handle than that of the prior construction in that the likelihood of the covering flap formed by panel C coming open in handling with attendant spoilage of the sterilization of the needle 21 is greatly reduced.
A further important advantage of the overlapping panel D and crimping 24, 25 will be discussed after consideration of FIGURE 6. FIGURE 6 shows an enlarged sectional view of the packaging material which is comprised of a base or inner layer of absorbent material, an intermediate layer 31 of metallic foil and an outer layer 32 of paper. Inner layer 30 is formed of absorbent material such as absorbent paper in order to retain the alcohol or other liquid used in keeping the surgical gut moist. Intermediate layer 31 which may for example be constructed of aluminum foil serves to provide a good liquid seal as well as to provide secure crimping of the ends of the package, the metallic foil taking a crimp better than ordinary paper. Outer layer 32 may have matter printed thereof such as identification markings and instructions as to use as is indicated in FIGURES 2 to 4.
The most important function of the three-layer material is to provide means for absorbing the moistening liquid and for sealing the liquid in the package. Regarding the sealing feature it will be appreciated that the snug closure of the package 10 provided by end panel of flap D greatly enhances the sealing effect of layer 31.
From the foregoing it can be seen that the configuration of the package, i.e., the multi-folded panel construction, the provision of the end flap D, the crimping of the edges of package, and the sealing provided by intermediate layer 31 all serve in retaining the surgical gut in a moist usable state. The absorbent sheathing provided by the absorbent layer 30 increases the reservoir for the moistening liquid while the specific packaging construction provides a sealed container for the liquid whereby the evaporation rate of the liquid is decreased. The arrangement disclosed further permits the package to be readily opened so that the gut can be removed quickly in an untangled state.
It is noted that in accordance with another important feature of the invention the surgical gut of the suture may be presoaked until optimal conditioning is reached. This technique enables an equilibrium condition to be reached and thus evaporation of the tubing fluid is combatted. The amount of tubing fluid placed in the package to give optimal conditioning to the surgical gut is a definite quantity. This quantity may be completely absorbed or almost completely absorbed particularly where an absorbent layer is included. With the inclusion of a pre-soaked absorbent layer spillage of the tubing fluid is also combatted because there is substantially no free fluid in the package.
It should be understood that the panel arrangement shown and described is only illustrative and, for example, panel A could be replaced by a panel extending outwardly of the upper edge section B and foldable to cover that section. Other arrangements could be utilized with some possible loss in ready removability of the suture. For example, the sides of the package could also be crimped and the end flap D eliminated. Further, it might be possible to eliminate crimping where the section of packaging material was quite large by using tight folds along the outside margins of overlapping portions of the package to form the container for the tubing liquid. A relatively tight seal may be achieved with this latter method where a layer of metallic foil is used for part of the package material. Other modifications will occur to those skilled in the art.
Having thus described our invention in the manner required by the Patent Statutes, We wish it to be understood that the foregoing disclosure is illustrative rather than definitive.
1. A package containing a suiture of the type requiring fluid for conditioning comprising a flexible Package material folded to form at least a bottom layer and a cover layer, the suture being disposed between the bottom layer and the cover layer; an end flap formed on said cover layer, said end flap being folded under said bottom layer to form a container for retaining moistening liquid adjacent the suture; and the upper and lower edges of said bottom and cover layers being crimped together, said crimping being the only means for sealing said upper and lower edges to prevent the escape of said moistening liquid.
2. A package in accordance with claim 1 wherein said packaging material is formed of a plurality of layers of material and comprises a layer of absorbent material for retaining moistening liquid adjacent the suture.
3. A package in accordance with claim 2 wherein said packaging material further comprises a layer of metallic foil.
4. A package in accordance with claim 3 wherein said package material further comprises an outer layer of paper capable of carrying printed material.
5. A package in accordance with claim 1 wherein the suture has a needle attached thereto and wherein said package material is further folded to produce a middle layer, the main portion of the suture being imprisoned between the middle layer and the bottom layer and the needle end of the suture being disposed between the middle layer and the cover layer.
6. A package in accordance with claim 1 wherein the suture has a needle attached thereto and the main portion of the suture, except for the needle, is disposed in a zig-zag pattern.
7. A package in accordance with claim 1 wherein the suture has a needle attached thereto and wherein said pack-age material is further folded along a longitudinal axis to produce a middle layer, the cover layer and the end flap being produced by a longitudinal fold line parallel to said fold producing said middle layer; the main portion of the suture being imprisoned between the middle layer and the bottom layer and being disposed in a zigzag pattern on said bottom layer, the needle end of the suture being disposed between the middle layer and the cover layer; the packaging material itself being formed of a plurality of layers of material including a layer of metallic foil.
8. A package in accordance with claim 1 wherein the suture is pre-soaked before insertion into the package.
9. A package in accordance with claim 8 wherein the packaging material includes an inner layer of absorbent material which is pre-soaked with tubing fluid before the suture is inserted and the pack-age is closed.
10. A package containing a suture of the type requiring fluid for conditioning comprising a flexible package material folded to form at least abottom layer and a cover layer, a suture laid out on said bottom layer and disposed between said bottom layer and said cover layer, an end flap formed on said cover layer and folded under said bottom layer to form a container for retaining moistening fluid adjacent the suture, the upper and lower edges of said bottom layer and said cover layer being crimped together, said crimping being the only means for sealing said upper and lower edges to prevent escape of said moistening fluid and said packaging material being formed of a plurality of layers of different materials and comprising a layer of absorbent material for retaining moistening liquid adjacent the suture and a layer of metallic foil material for aiding in forming said sealed container.
References Cited UNITED STATES PATENTS 2,069,335 2/1937 Salfisberg 2293.5 X 2,402,981 7/1946 Beal et al 206--63.2 2,959,280 11/1960 Lloyd 206--63.3 2,993,589 7/1961 Zoller et a1 206-63.3 3,332,550 7/1967 Sejman 20663.2 3,357,550 12/1967 Holmes et al. 206-633 FOREIGN PATENTS 358,297 10/1931 Great Britain. 453,345 9/ 1936 Great Britain.
MARTHA L. RICE, Primary Examiner US. Cl. X.R. 2293.5, 48, 62