US3315802A

US3315802A - Package for sterile storage of surgical devices and accessories

Info

Publication number: US3315802A
Application number: US501752A
Authority: US
Inventors: Lonholdt Hans Christian Ronnow; Bjarno Knud Maro Henrik
Original assignee: Novo Terapeutisk Laboratorium AS
Current assignee: Novo Terapeutisk Laboratorium AS
Priority date: 1963-06-21
Filing date: 1965-10-22
Publication date: 1967-04-25
Anticipated expiration: 1984-04-25
Also published as: BE649496A; NL6407069A; CH413220A; DE1251906B; DK115863B; FI40306B; AT257031B; GB1022088A

Description

April 25, 1967 Filed Oct. 22, 1965 H. C; R. LZNHOLDT ETAL PACKAGE FOR STERILE STORAGE OF SURGICAL DEVICES AND ACCESSORIES 3 Sheets-Sheet l i 25, 1967 H. c. R. LQNHOLDT ETAL 3,

PACKAGE FOR STERILE STORAGE OF SURGICAL DEVICES AND ACCESSORIES Filed Oct. 22, 1965 3 Sheets-Sheet 2 Fig.6 0 .7

R. LQNHOLDT ETAL PACKAGE FOR STERILE STORAGE OF SURGICAL April 25, 1967 DEVICES AND ACCESSORIES 3 Sheets-Sheet :3

Filed Oct. 22, 1965 United States Patent 3,315,802 PACKAGE FUR STERILE STORAGE OF SURGICAL DEVICES AND ACCESSORIES Hans Christian Rannow Lnholdt, Espergaerde, and Knud Maro Henrik Bjarngzl, Stenlose, Denmark, assignors to Novo Terapeutisk Laboratorium A/, Copenhagen, Denmark, a Danish joint-stock company Filed Oct. 22, 1965, Ser. No. 501,752 Claims priority, application Denmark, June 21, 1963,

2,966/ 63 Claims. '(Cl. 206-56) This application is a continuation-in-part of application Ser. No. 376,116, filed June 18, 1964, and now abandoned.

In surgery use is as known being made of a series of different devices, accessories and auxiliaries. The demand on sterility of such devices, accessories and auxiliaries is still increasing. Among said devices, accessories and auxiliaries may e.g. be mentioned suture and ligature materials, haemostatic forcets, wound retractors and wound clips, knives, scissors, forcep and catheters.

As far an a series of the said devices and auxiliaries are concerned, sterilization takes place in the hospitals, preferably by autoclaving, in that the devices or auxiliaries having been wrapped separately or several together are put into a tray or bowl which is placed into an autoclave and is autoclaved. This applies e.g. to peans, wound retractors and wound clips and to knives and scissors. The sterilized articles are then removed the very moment when they are to be used or they are put in unwrapped condition on the operating table in such case where they are to be at disposal with a very shtort notice.

Other devices, such as suture and ligature materials with appertaining needles, if any, are sterilized on an industrial basis outside the hospitals. Thus, they are presented in sterile sealed packages which are to be opened before use.

The present invention relates to a package for sterile storage of suture and ligature materials, peans, wound retractors, knives, catheters and other surgical devices and auxiliaries, and the object of the invention is to provide a package which on one hand reduces the danger of infection due to contamination of the sterile surgical devices and auxiliaries prior to their use, and on the other hand renders possible an easy and quick removal of the devices and auxiliaries from the packages.

The package according to the invention is of the kind which consists in or contains a bag destined for taking up the surgical articles, and it is characterized by the fact that the side-Walls of said bag are slitted up from the open end of the bag so as to form flaps, said flaps being loaded with such weight that when the bag is placed bottom down the flaps will fall out to the sides and thereby provide free and easy admission to the interior of the bag.

The loading of the side-wa l flaps is preferably effected by means of weighty strips provided at the free ends of the flaps.

When the package according to the invention consists only of the said bag referred to in the following as the flap bag, the package is to be used in such cases where the surgical devices are sterilized in the hospitals. The said devices are placed separately or several together in a flap bag of suitable size and the bags are placed in a bowl or a tray and are sterilized by autoclaving. When the said device or devices is or are to be used one grasps the bottom of the flap bag, the bottom is turned downwards, and the flaps will fall out to the sides, which provides an easy and free admission to the contents of the bag. In this manner a real unwrapping of the sterile device immediately prior to use is avoided, and the danger "ice of the device being made unsterile is reduced since it does not come into contact with the surrounding air before it is to be used, and not at all With the outer faces of the flap bag which might have become unsterile.

For storage of suture and ligature materials and other devices which are to be used only on one occasion and the final sterilization of which is made on an industrial scale upon finished packages, the flap bag is according to the invention placed in a sealed outer bag of germ-tight material having its bottom adjacent the extremity of the outer bag destined to be opened. Thus, when the outer bag is opened by cutting or tearing, with the opening turned upwards, the bottom of the flap bag will be apparent, and when grasping the bottom, pulling out the flap bag and turning the bag the flaps will automatically fall out to the sides and the contents of the bag will become easily and freely accessible for direct use. In this manner the contents of the flap bag will not come into contact with the outer faces of the flap bag having touched the edges of the outer bag, which edges might be unsterile, and it becomes unnecessary to carry out an additional tearing or cutting in order to get ac- CesS to the sterile surgical device in the inner bag, such as has previously been the case.

In connection with surgical accessories having a considerable length it may also be appropriate to make use of an outer germ-tight bag, which may then surround only the open end of the flap bag.

In the production of the flap bag it is appropriate to make use of transparent foils of plastics which can be welded together by heating, e.g. by high-frequency welding. As examples of suitable plastics may be mentioned ethylcellulose, cellulose acetate, cellulose propionate, cellulose acetate butyrate, polyamides, such as polyamino undecanoic acid, polyvinyl compounds, polyesters, polyethylene, polypropylene, polymonochlorotrifiuoroethylene and polytetrafluoroethylene. Use may also be made of laminates of two or more of the said plastics. Further papers, such as parchment paper, are also applicable.

If the flap bag is used together with a sealed outer bag of germ-tight material, the latter may also be produced from the same material as the flap bag. If the package according to the invention is used for sterile storage of suture or ligature material requiring a conditioning during the storing period by the presence in the package of a water-containing moistening agent being or the vapors of which being in contact with the suture or ligature material, the sealed outer bag should be prepared from a material being impermeable or difiicultly permeable to the vapors of the employed moistening agent. Suitable materials for the said purpose are foils produced from appropriate laminates of the above mentioned plastics or foils of nylon, polymonochlorotrifluoroethylene, polytetrafiuoroethylene or polyethylene glycolterephthalates. The sealed outer bag may also be produced from a laminated metallic foil, e.g.an aluminum foil being coated at its inner face with a thin film of polyethylene or another plastic which may be welded by the action of heat, and at its outer face with a thin layer of paper.

When selecting the material for the package according to the invention regard should be taken not only to the manner in which sterilization has been performed, but also to the purpose for which the package is intended. Some plastics, such as polyethylene, are not suitable when the sterilization takes place by autoclaving. When the package according in the invention is used for sterile storage of suture and ligature materials in the presence of a water-containing moistening agent, it is of course necessary that the employed materials be unable to be affected by the moistening agent and that the outer bag be impermeable thereto. The flap bag may be produced from a material being permeable to the moistening agent Q and its vapors, such as polyethylene, particularly when the moistening agent is placed in the space or interstice between the flap bag and the sealed outer bag. This is, however, not absolutely imperative since the vapors of the moistening agent can penetrate into the flap bag through the slittered side-walls.

The invention is more fully explained in the following, reference being made to the drawing, on which FIG. 1 shows a flap bag according to the invention of horizontal front view and containing a surgical device,

FIG. 2 shows a vertical cross section of the bag shown in FIG. 1 with the flaps of the bag spread out to the sides,

FIG. 3 a front view of a suture material package according to the invention,

FIG. 4 the same after the outer bag has been opened and the fiap bag has been partially pulled out,

FIG. 5 the removed flap bag seen partially in section with the bottom down, and the flaps spread out to the sides,

FIG. 6 a front view of another embodiment of a suture material package according to the invention,

FIG. 7 the same after the outer bag has been opened and the flap bag has been partially pulled out,

FIG. 8 the removed flap bag in perspective with the bottom down and the flaps spread out to the sides,

FIG. 9 a side-view of a package containing a catheter and FIG. 10 a side-view of another package also containing a catheter.

In FIGS. 1 and 2 1 designates a bag made from a foil of plastic, such as polypropylene, by bending the foil for the formation of the bottom 2 of the bag and welding the side edges for the formation of the sealed side-walls 3 which extend only about one third of the length of the bag. How far in height the bag should be sealed in the sidewalls depends on the surgical device to be contained in the bag.

The side-walls of the bag have at their free top ends thickenings for the formation of strips 4 having such a a weight that the sidewalls-as shown in FIG. 2will spread out tothe sides in the form of flaps 5.

In the bag 1 is disposed a surgical device which in the shown embodiment constitutes a blade 6 of a surgeons knife but which may be any other device, the size of the bag and the length of the flaps 5 being adapted to the size and form of the surgical device to be stored in the bag. The bag may be provided with a weakened line 14 below the strips 4 and/ or with a weakened line 15 above the sealed side-walls 3 in order to facilitate the falling out of the flaps 5.

The bag shown in FIGS. 1 and 2 with the flaps 5 and the strips 4 is used in the following manner:

The surgical device or devices to be sterilized is or are placed in the bag which is dimensioned to suit the size and form of the device in question, and the :bag is placed in a bowl, tray or other recipient and is autoclaved or sterilized in another manner. When the sterile device is to be employed, the bottom of the bag is grasped and the bag is raised so as to make its bottom turn downwards. This causes the flaps 5 to spread out to the sides so that the device in the bag will become freely and easily accessible.

It will be seen that at no time the sterile surgical device comes into contact with the outer surfaces of the bag so that there is no danger of the device becoming unsterile even if the outer surfaces of the bag for some reason or other have lost their sterility. Further it will be seen that after the flaps 5 have spread out to the sides the sterile device is directly and easily accessible for the operator without having been in the hands of any other person.

In FIGS. 3 to 5 '7 designates a suture'thread of silk, nylon or catgut coiled up and kept together by means of a slip of paper 8 on which information as to the type and length of the thread may be printed. Instead of the slip of paper 8 use may also be made of a wrapping or a packing of the thread in filtering paper or the like material. The thread 7 is placed in a bag of similar construction as that of the bag 1 in FIGS. 1 and 2, the bag being provided with a bottom 2,, side-walls 3 which have been welded together and flaps 5. It differs from the bag in FIGS. 1 and 2 only in that the upper edges 9 of the sidewalls have been bent and hold a piece of filtering paper 141 so that each of the edges 9 and the pieces of filtering paper 10 form the strips of the bag corresponding to the strips 4. In the pieces of filtering paper 10 a water-containing moistening agent is absorbed, such as ethanol, if the thread is produced from catgut. This is not necessary, when the thread is produced from silk or nylon and in such case the strips of the bag may be formed in the same manner as in FIGS. 1 and 2.

The bag 1 is placed in a sealed outer bag formed from two aluminum foils 11 provided at their inner surface with a layer of polyethylene or polypropylene and at their outer surface with a layer of paper and united with each other by weldings 12 along the edges. At the top portion at one side edge there is a notch 13 by means of which it is easy to tear off the bottom of the outer bag when the package is to be opened.

In FIG. 4 such tearing off has been made and the bag 1 has been partly pulled out from the torn outer bag. When the bag thereafter is completely pulled out bottom down and is turned its flaps 5 will spread out to the sides, such as shown in FIG. 5, and the suture material will be easily and freely accessible without having been in contact with the torn edges of the outer bag which will usually not be sterile at the outsides.

In FIGS. 6 and 7 1 designates an inner bag made from a plastic foil such as polypropylene, by bending the said foil for the formation of the bottom 2 of the bag. The side-walls of the bag are welded together merely at the bottom. Thereby long flaps S are formed. The latter have at their top portion thickenings for the formation of strips 4 having such weight that the, flaps 5 forming the sidewalls of the inner bag will fall out to the sides when the bag is placed bottom down. The strips 4- may consist of the same material as the bag provided the said material is thicker, but they may also be made from narrow strips of cardboard which have been glued to the flaps.

At the bottom of the inner bag there is provided a holding device consisting in the shown embodiment of a vertical stiff strip 16, integral with a horizontal footing 17 which extends along the bottom 2 of the bag 1 and is glued to the bottom 2. A suture thread 7 of silk, nylon or catgut is coiled up and placed in an envelope 18 being provided with a pocket 19 wherein the strip 16 is pushed.

The inner bag 1 is placed in a sealed outer bag which is made from two aluminum foils 11 provided at their inner surface with a layer of polyethylene or polypropylene and at their outer surface with a layer of paper and united with each other by weldings 12 along the edges. At the top portion at one side edge there is a notch 13 by means of which it is easy to open the outer bag.

In FIG. 7 such opening has been carried out and the bag 1 is partially pulled out from the torn outer bag. When thereafter the bag 1 is completely pulled out bottom turned up and is turned 180, its flaps 5 will because of the weight of the strips 4 fall out to the sides, such as shown in FIG. 8.

Since the inner bag is pulled out from the outer bag bottom turned up, germs, if any, being present on the torn edges of the outer bag and on its outer sides will not be allowed to fall down into the inner bag and thereby give rise to a contamination of the contents of the inner bag. Further, the position of the surgical device in the inner bag will be fixed since it is mounted on the holding device formed by the strip 16 with the footing 17 at some distance from the bottom 2. Thus when grasping the bottom of the inner bag 1 in order to pull it out from the outer bag, the surgeon will not accidentally grasp the envelope 18 and thereby impede removal of the inner bag.

As, moreover, the flaps are relatively long in that they extend down to the bottom 2 of the bag 1, it'will be sufficient to provide for a relatively small weight of the strips 4, which reduces the weight of the package. If the flaps were shorter and in case the surgical device with bag that the side-walls of the bag swell in the position shown in FIG. 7 one would even with a relatively considerable weight of the strips 4 run the risk that the weight of the flaps be insufiicient to cause the latter to fall out to the sides when the inner bag is pulled out from the outer bag and is placed bottom down.

The package shown in FIGS. 6 and 7 has a relatively small size and a relatively slight weight. In addition thereto a quick and easy removal of the surgical device and/or auxiliary being stored under sterile conditions is secured, which means that the risk of contaminating said device or auxiliary during its removal is considerably reduced.

Though the package is illustrated in connection with a suture thread as the surgical device and auxiliary, it may also be used in connection with other surgical devices and auxiliaries such as knives, haemostatic forcets and wound retractors. The holding device shown is to be considered as an illustrating embodiment, only. If desired, the package may be provided with several holding devices, in that each holding device carries for instance a suture thread packed in an envelope, if desired.

In FIG. 9 a flap bag 20 provided with weighty strips 21 contains a catheter 22. The side-walls of the bag 20 are slitted up to the bottom of the bag and the catheter 22 is kept in place by means of two weldings 23. The flap bag 20 is surrounded by an outer germ-tight bag 24 consisting of a main portion 25 and a bottom portion 26, the latter being joined to the former at 27.

When the catheter in the package is to be used, the bottom portion 26 is removed from tthe main portion 25 and the flap bag 20 is placed with the bottom down, which makes the catheter 22 accessible.

FIG. shows the same flap bag as in FIG. 9, but the outer germ-tight bag only surrounds the lower part of the flap bag 20 to which the bag 28 is joined at 29. When the outer bag 28 is released from the flap bag 20 and the latter is placed with the bottom down, the catheter will be accessible.

The principle of keeping the surgical device in place in the flap bag by means of the weldings 23 shown in FIGS. 9 and 10 may also be used in connection with the flap bag shown in FIGS. 3 and 4, in which case the sidewalls of the flap bag are slitted up to the bottom of the bag, which makes it superfluous to seal the side-walls at their edges at the bottom of the bag.

The outer bag may also be produced from a plastic foil, e.g. nylon or polyethylene which may be welded together by the action of heat.

The embodiment shown in FIGS. 3 to 8 may further be modified in that the suture material is placed in a sealed bag containing a moistening agent, if desired, within the flap bag 1, but such modified embodiment is less appropriate since it requires a special cutting or slitting in order that free admission to the suture material may be obtained.

In the foregoing sterilization by autoclaving is mentioned, but it is also possible to use other sterilizing methods, such as dry sterilization by ethylene oxide gas or sterilization by irradiation with 8 or 'y rays.

We claim:

1. A package for sterile storage of suture and ligature material, haemostatic forcets, wound retractors, knives, catheters, and other surgical devices which comprises an envelope for holding at least one of said devices, said envelope having a closed bottom and sidewalls joined with one another a selected distance from the bottom of the envelope, said side walls being flexible and extending beyond the joined portion to form flaps, said flaps being loaded with such weight that when the envelope is placed bottom down, said flaps fall out to the sides and thereby provide free and easy admission to the interior of the envelope.

2. A package according to claim 1, wherein said flaps are provided with weighty strips at their free ends.

3. A package according to claim 2, wherein said strips on the flaps of the envelope are formed by thickening of the flaps.

4. A package according to claim 1, in which holding means are provided at the bottom of the envelope for fixing the position of the surgical device.

5. A package according to claim 4, in which the holding means comprises a stiff projecting strip secured to the bottom of the envelope.

6. A package according to claim 5, in which said projecting strip is integral with a footing, said footing extending along the bottom of the envelope and secured thereto thereby securing said projecting strip to the bottom of the envelope.

7. A package according to claim 5, in which said projecting strip is adapted to fit in a pocket in an additional envelope for the surgical device.

8. A package for sterile storage of suture and ligature material, haemostatic forcets, wound retractors, knives, catheters and other surgical devices in the presence of a water-containing moistening agent therefor which comprises an envelope for holding at least one of said devices, said envelope having a closed bottom and sidewalls joined with one another a selected distance from the bottom of the envelope, said side walls being flexible and extending beyond the joined portion to form flaps, said flaps being provided at their free ends with weighty strips of a porous material in which the moistening agent has been absorbed.

9. A package for sterile storage of suture and ligature material, haemostatic forcets, wound retractors, knives, catheters, and other surgical devices which comprises an envelope containing at least one of said devices, said envelope having a closed bottom and sidewalls joined with one another a selected distance from the bottom of the envelope, said side walls being flexible and extending beyond the joined portion to form flaps, said flaps being loaded with such weight that when the envelope is placed bottom down, said flaps fall out to the sides and thereby provide free and easy admission to the interior of the envelope, and a germ-tight outer bag surrounding and sealing at least the top, open portion of said envelope.

10. A package for sterile storage of suture or ligature material according to claim 9, in which said package contains a water-containing moistening agent for said material.

11. A package for sterile storage of suture or ligature material according to claim 9, in which holding means are provided at the bottom of the envelope for fixing the position of the surgical device.

12. A package for sterile storage of suture and ligature material, haemostatic forcets, wound retractors, knives, catheters, and other surgical devices which comprises an envelope containing at least one of said devices, said envelope having a closed bottom and sidewalls joined with one another a selected distance from the bottom of the envelope, said side walls being flexible and extending beyond the joined portion to form flaps, said flaps being loaded with such weight that when the envelope is placed bottom down, said flaps fall out to the sides and thereby provide free and easy admission to the interior of the envelope, and a sealed outer bag of germ-tight material surrounding said envelope, the bottom of said envelope being adjacent the extremity destined to be opened of said outer bag.

13. A package for sterile storage of suture or ligature material according to claim 9, in which the holding means comprises a stiff projecting strip secured to the bottom of the envelope.

14. A package for sterile storage of suture or ligature material according to claim 13, in which said projecting strip is integral with a footing, said footing extending along the bottom of the envelope and secured thereto thereby securing said projecting strip to the bottom of the envelope.

15. A package for sterile storage of suture or ligature material according to claim 13, in Which said projecting strip is adapted to fit in a pocket in an additional envelope for the surgical device.

8 References Cited by the Examiner UNITED STATES PATENTS 892,074 6/ 1908 Obici. 1,240,880 9/1917 Rink 20616 1,962,900 6/ 1934 Hirsch.

FOREIGN PATENTS 314,166 6/1929 Great Britain.

10 LOUIS G. MANCENE, Primary Examiner.

THERON E. CONDON, Examiner.

J. M. CASKIE, Assistant Examiner.

Claims

1. A PACKAGE FOR STERILE STORAGE OF SUTURE AND LIGATURE MATERIAL, HAEMOSTATIC FORCEPS, WOUND RETRACTORS, KNIVES, CATHETERS, AND OTHER SURGICAL DEVICES WHICH COMPRISES AN ENVELOPE FOR HOLDING AT LEAST ONE OF SAID DEVICES, SAID ENVELOPE HAVING A CLOSED BOTTOM AND SIDEWALLS JOINED WITH ONE ANOTHER A SELECTED DISTANCE FROM THE BOTTOM OF THE ENVELOPE, SAID SIDE WALLS BEING FLEXIBLE AND EXTENDING BEYOND THE JOINED PORTION TO FORM FLAPS, SAID FLAPS BEING LOADED WITH SUCH WEIGHT THAT WHEN THE ENVELOPE IS PLACED BOTTOM DOWN, SAID FLAPS FALL OUT TO THE SIDES AND THEREBY PROVIDE FREE AND EASY ADMISSION TO THE INTERIOR OF THE ENVELOPE.