US2965225A - Suture package - Google Patents

Description

e 1960 H. F. ZOLLER ET Al. 2,965,225

SUTURE PACKAGE Filed April 9, 1957 2 Sheets-Sheet 1 INVENTORS 24 JOHN L. NEUMEYER HOWARD E ZOLLER ATTORNEYS Dec. 20, 1960 H. F. ZOLLER ET Al.

SUTURE PACKAGE 2 SheetsSheet 2 Filed April 9, 1957 INVENTORS JOHN L. NEUM Y HOW/1R 0 F, 20L E @2904? '29- w ATM/8,05%;

SUTURE PACKAGE Howard F. Zoller, Lebanon, and John L. Neumeyer,

Highland Park, N.J., assignors to Ethicon, Inc., a corporation of New Jersey Filed Apr. 9, 1957, Ser. No. 651,778

Claims. (Cl. 206-635) This invention relates to a Suture packaging arrangement including a package which may readily be torn to open and which is arranged so that the sutures may be withdrawn with the same motion required to tear open the package. More particularly the invention relates to such a package in which the sutures are connected to one end of the package so that they may be drawn out of the package by the act of tearing ofi the end. The invention still further relates to a packaging arrangement wherein a number of packages of a tearable material are placed in a container and immersed in a sterilizing solution, the packages being of sufficient density so that they will not float in the solution but will be completely immersed.

Sutures normally consist of strands of silk, gut, linen, nylon or the like and are utilized in surgical operations. The packaging of such sutures should be such that the sterile condition of the suturesmay be maintained throughout the existence of the unopened package and during the process of removal from the package. In addition, the packaging of such sutures should facilitate the handling of the sutures to eliminate extra work and unnecessary delay.

It should be understood that the terms suture and ligature are used to describe the same items, the difference in medical terminology relating to their application in surgery. However, for convenience the term suture will be used hereinafter to indicate either sutures or ligatures.

It is accordingly an object of the present invention to provide an inexpensive hermetically sealed package containing surgical sutures which are quickly and easily'removable from the package.

It is another object of the present invention to provide a sealed package containing a plurality of folded sutures which may be removed with a minimum likelihood of entanglement of the sutures.

It is still another object of the present invention to provide a suture package in which the sutures may be withdrawn from the package by the same act required to open the package.

It is a further object of the present invention to provide a packaging arrangement including a non-breakable compact suture package which is of sufiicient density so that it may be placed or packed in an antiseptic solution and will not fioat but will be covered by the solution and thus be maintained in a sterile condition.

It is a still further object of the present invention to provide a suture package of the foregoing type wherein a weight is provided at one end of the package to maintain the package in an upright condition when immersed in sterilizing solution to facilitate grasping of the package with surgical instruments.

It is a still further object of the present invention to provide an inexpensive hermetically sealed packa e for sutures which is penetrable to electron beam radiation so that the entire package and contents may be sterilized by this means after sealing of the package.

Figure 2 is an isometric view of the suture package of Figure 1 showing the package torn open and the contents partially removed;

Figure 3 is a plan view of an alternative type of package according to the present invention which is of such a length that the sutures therein may be arranged with only a single fold;

Figure 4 is a sectional view of a container which may be used for packaging the package of Figures 1 and 2 in a sterilizing solution; and

. Figure 5 is a sectional view of the arrangement of Figure 4 with part of the contents removed.

Referring first to Figures 1 and 2, there is shown an envelope 11 which is formed by folding and sealing the edges 12, 13 and 14 of a piece of flexible material. Although the envelope 11 may be formed of many different materials including but not limited to paper, plastic, metal foil or the like, it is preferred that the envelope 11 be impervious to micro-organisms. It is furthermore preferred that the envelope be impervious and not chemically affected by antiseptic solutions, such as an alcoholformaldehyde solution.

It is contemplated that the most satisfactory material for the envelope 11 would be metal foil, such as aluminum foil. In addition to the advantages above, aluminum foil is relatively heavy so that an envelope of aluminum foil may readily be constructed which is not so thick that it is difi'icult to tear but which is sufliciently dense so that it will sink in the antiseptic solution.

This quality of high density would be of particular value in the event that the packages according to the present invention were to be shipped in a rigid sealed container containing an antiseptic solution such as is shown in Figures 4 and 5. It should be understood, however, that the package according to the present invention need not be packed for shipping in accordance with Figures 4 and 5 but may be packed in other manners as well.

It is also desirable in some instances that the material used for the envelopebe penetrable to electron beam radiation. An aluminum foil envelope may thus be sterilized by electron beam radiation together with its contents after it has been sealed. Although this procedure obviously simplifies the sterilized packaging operation, the packages may be sterilized in a sterilizing gas or vapor atmosphere before sealing, by heat, or by any other method.

Where aluminum foil is ut lized as material for the envelope 11, the seal at the edges 12, 13 and 14 may be made by the use of a heat-bond ng resin. Other methods of sealing the envelope also could be used such as directly fusing the metal by the application of heat, or any other suitable method could be used.

The envelope 11 of Figure l is shown folded on one side and sealed on three sides. However, it is obvious that the envelope could be constructed of two sheets and sealed on four sides or that it might be constructed of tubular material sealed only on the ends or in any other manner which would result in a sealed envelope.

A notch 15 m y be provided near the top of the envelope 11 to facilitate the tearing of the envelope. The notch 15 will mark the place where the envelope should be torn and at the same time provide a start to facilitate the tearing operation.

A tab 16 is provided secured in the top seal 12 of the envelope 11. The tab 16 is best shown in Figure 2 Aluminum foil fulfills this condition also.

where it may be seen that the tab shown for purposes of illustration consists of an elongated strip of flexible material folded in the middle and having both ends sealed into the top seal 12 of the envelope 11. The inventon is not limited to the particular type of tab shown. It is obvious for instance that the tab 16 could be independently attached to the top portion of the envelope 11 rather than being sealed within the top seal 12 or rather than a loop type tab 16, an apertured.tab, or hook type.

ab o any other u le a ould be sed hold e contents of the envelope 11.

The material of which the tab 16 is formed would usually not be critical. It may be convenient to form the tab 16 of the same material used for the envelope 111. In some cases it is desired to pack the sutures in a container which contains a fluid such as alcohol to wet the sutures, or else to package the sutures in a moist condition so that they will be moist at the time they are to be used. In this event it is desirable that the tab 16 be formed of a material which is not adversely aliecied by a packing fluid such as alcohol. If the tab 16 is formed of aluminum foil, this condition would be met.

Within the envelope 11 a plurality of. sutures 17' are looped through the tab 16 and retained thereby. The envelope of Figures 1 and 2 is of such a length that the sutures 17 must be folded several t'mes to fit in the package. The sutures 17 may be folded in any desired fashion, not necessarily the manner shown in Figures 1 and 2. The sutures may, for example, be fo'ded as shown in U.S. Patent No. 2,702,627 to A. B. Kennison and Howard F. Zoller. The precise manner in which the sutures are folded within the package does not constitute a part of the present invention.

A shield 18 of paper or other material may be placed around the sutures 17 if desired. Use of the shield 18 avoids any possibility of the sutures 17 b ecom'ng caught in the envelope seals 12, 13 and 14. The shied 18 would therefore be particularly useful where a gutinous bonding agent is used to seal the edges 12, 13 or 14 of the envelope 11. A flap 19 may be provided at the bottom of the paper shield 18 which may be folded over to further insure that the sutures 17 do not become caught in the bottom seal 14 of the envelope 11.

As previously discussed, it may in some cases be desired to package the sutures 17 in a wet condition. or, alternatively, to include packing fluid in the envelope 11. (515132011156 be selected to be unaffected by the packing Although the package shown in Figures 1 andv 2, is illustrated as containing a plurality of sutures 17, t' e number of sutures contained is purely a matter of choice and in fact the package could be used to enclose only a single suture.

Figure 3 shows a somewhat dififerent suture package arrangement. In Figure 3 an envelope 21 of construction similar to that of the enveTope shown in Figures 1 and 2 is shown. The envelope 21 differs however in that it is of such a length that sutures 27 may be placed in the envelope with only a single fold. The length of the sutures may be 18 inches, for example, thereby requiring a package somewhat longer than 9 inches. Tne envelope 21 may be sealed at edges 22, 23 and 24 in a manner similar to that previously described for envelope 11. The long envelope 21 may advantageously be provided with three notches 25a, 25b and 25c rather than a single notch provided for envelope 11. Thus the envelope 21 may be opened in the same manner as envelope 11 by utilizing notch 25a in which case the sutures 27 may be removed from the envelope by reason of their engagement with the loop tab 26. This procedure would be followed where it was desired that all sutures be removed for use at the same time.

In the event that it is contemplated that the sutures would be, used one at a time, the envelope 2.1 may; be.

In this event the material for the shied 18 should 4 torn across the bottom utilizing notch 250. The sutures 27 extend beyond the end of the shield 28 so that the sutures may then be grasped individually and pulled through the loop tab 26.

In the event that it was desired to cut the sutures 27 into short lengths, the complete envelope 21 could be cut at the center notch 25b thereby cutting the sutures into shorter lengths. The sutures could then be removed collectively or individually from the respective halves of the envelope 21.

It will thus be seen that the long envelope 21 has certain advantages which may be desired in some instances and illustrates the manner in which the package may be modified for particular purposes within the scope of the invention.

Figure 4 shows a container 29 composed of a vessel 31 which may be constructed of metal with a cover 32. In the container 29 is placed a quantity of sterilizing solution 33. The sterilizing soluition 33 may be. an alcohol-formaldehyde solution, for example.

A. number of suture packages 11 are placed in the solution 33. Packages 11 may be similar to that shown in Figures 1 and 2. As previously explained, where this particular package arrangement utilizing sterilizing solution is used it is particularly desirable that the pack.- age 11 be made of a relatively heavy material such as. metal foil or otherwise weighted so that its specific gravity is sufficiently great to cause it to be fully immersed in the sterilizing solution 33.

In the event that the packages 11 are to be packed in a sterilizing solution it is also desirable that one end of, the package 11 be weighted as by a fold of metal foil 14 as shown in Figures 1 and 2. The desirability of this arrangement is illustrated in Figure 5. Figure 5 shows the container of Figure 4 after most of the packages 11 have been removed. From Figure 5 it will be seen that by weighting one end of the packages 11 and arranging the other end to have a specific gravity less than the sterilizing solution, the packages remain upright in the sterilizing solution. Thus the weighted package 11 remains upright so that it may readily be grasped by means of tongs or other appropriate surgical instruments. Since a foldzd end of the package might prove ditficult to tear, it is preferred that the end opposite the weighted end he opened, and if a tear-notch is provided that it be located. at this opposite end as shown in the drawings.

It should be understood that the suture package 11 need not necessarily be packaged in a sterilizing solution. O,her means of packing of packages 11 may be em-. ployed in which case the specific gravity of the packages is relatively unimportant. It should be pointed out however that even though the packages 11 are not initially packed in a sterilizing solution, it may be desirable in some cases for the consumer of the goods to. re-sterilize the package after its. original container has been broken. A convenient method of re-sterilization would be to utilize the" sterilizing solution in substantially the same.

manner as that shown in Figures 4 and 5. Therefore, even though the packages 11 were not originally-packed in a sterilizing solution it might be contemplated that re-sterilization of the packages would be desired in which case weighted packages of particular specific gravity would still be useful.

Although the package has been illustrated as a contaIner for surgical sutures it will be obvious that other med'cal supplies which must be provided in a sterile condition could also be packed in accordance with the present invention.

It should be understood that the particular embodiments of the invention shown are presented by way of illustration only and that modifications as. suggested above or other modifications could be made within the scope,

of the present invention. The invention is therefore not to be. construedto be limited tothe particular embodh,

ment shown but is to be limited solely by the appended claims.

What is claimed is:

1. A package assembly for surgical supplies comprising a container, a sterilizing fluid within said contalner, and a plurality of packages within said container and immersed in said fluid, each said package comprising a hermetically sealed tearable metal foil envelope having means therein to facilitate tearing of said envelope, a weighted portion at one end of said envelope, at least one surgical suture within said envelope and a thin sheet of flexible material wrapped about said suture, said package having an effective specific gravity slightly greater than that of said sterilizing fluid and the contents and inner surfaces of said package being in a sterile condition.

2. A package assembly for surgical supplies comprising a container, a sterilizing fluid within said container, and a plurality of packages within said container and immersed in said fluid, each said package comprising a hermetically sealed tearable aluminum foil envelope having at least one notch therein to facilitate tearing of said envelope, a weighted portion at one end of said envelope, a substantially non-tearable tab extending within said envelope and secured to the opposite end of said envelope, at least one surgical suture within said envelope and held by said tab and a thin sheet of flexible material wrapped about said suture, said package having an effective specific gravity slightly greater than that of said sterilizing fluid and the contents and inner surfaces of said package being in a sterile condition.

3. A package assembly for surgical supplies comprising a container, a sterilizing fluid within said container, and a plurality of packages within said container and immersed in said fluid, each said package comprising a hermetically sealed tearable aluminum foil envelope formed by folding a rectangular piece of aluminum across the middle and sealing the two halves along the three unfolded edges, said envelope having at least one notch in an edge thereof to facilitate tearing of said envelope 4 and having a weighted end, a substantially nontearable loop tab extending in said envelope and sealed between the sides of said envelope at one end thereof, at least one surgcal suture within said envelope and threaded through the loop of said tab and a thin sheet of flexible material wrapped about said suture, said package having an eflective specific gravity slightly greater than that of said sterilizing fluid and the contents and inner surfaces of said package being in a sterile condition.

4. A suture package comprising an hermetically sealed envelope having one end removable by tearing, a suture within said envelope, and a substantially nontearable and permanent removing and supporting tab secured in the removable end of said envelope, said tab forming a loop around the suture and being secured thereto by said loop and being adapted to remain secured both to said suture and to said removable end and to remove completely the suture from said envelope when said removable end is torn from the envelope, the tab providing permanent support for the suture after it has been removed from the envelope.

5. A surgical supply container according to claim 4 wherein means is provided for facilitating tearing of the removable end from said envelope in a tearing area extending across said envelope and said tab extends through the tearing area.

References Cited in the file of this patent UNITED STATES PATENTS 618,677 Humphrey Jan. 31, 1899 737,181 Weaver Aug. 25, 1903 1,516,137 Bernstein Nov. 18, 1924 1,971,570 Lukens Aug. 28, 1934 2,402,982 Steenbergen July 2, 1946 2,457,924 Salfisberg Jan. 4, 1949 2,824,642 Stoltz Feb. 25, 1958 FOREIGN PATENTS 91,832 Germany Sept. 3, 1896 323,344 Great Britain Jan. 2, 1930 515,862 Canada Aug. 23, 1955

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