US 3143209 A
Description (OCR text may contain errors)
All@ 4, 1964 1. w. TURlANsKY 3,143,209
SURGICAL PACKAGE Filed July 16, 1962 2 Sheets-Sheet 1 ATTO R N EY All@ 4, 1954 L w. TuRlANsKY 3,143,209
SURGICAL PACKAGE Filed July 16, 1962 2 Sheets-Sheet 2 INVENTOR y/v Ma/muxo ATTORNEY United States Patent O 3,143,269 SURGICAL PACKAGE Iwan Wolodymyr Turiansky, South Orange, NJ., assigner te Ethicon, Inc., a corporation of New Jersey Filed .lnly 16, 1962, Ser. No. 209,889 Claims. (Cl. 20e-63.3)
The present invention relates to interiorly sterilized strippable seal packages for sterile surgical objects such as suture items or sterilized packets containing suture items.
Typically, such packages have been in the form of envelopes of two sheets of material joined by a strippable seal. Stripping flaps are provided at one end of the package and are adapted to be gripped and pulled away from one another to strip the seal and separate the two pieces of sheet material, thereby exposing the contents of the package. It is conventional to make the envelopes of a plastic sheet material such as Mylar or a Mylar laminate with polyethylene, triuoromonochloroethylene, or the like, and to form the strippable seal by heat sealing two halves of the envelope together along a relatively narrow seal line.
There are two ways oi' removing the sterile contents, or sterile object, from a strippable envelope of this type. First, the envelope may be held with the stripping aps down and the flaps may be pulled apart to separate the halves of the envelope. At a given point when the sterile object is free it will drop from the envelope. This technique is not always satisfactory for a number of reasons. First of all, it requires a sterile table, or the equivalent, on which the sterile object may be deposited. In an emergency procedure, such a table or sterile repository may not be available. This technique also requires that the suture or other surgical object be picked up again by the surgeon or the nurse utilizing some sterile technique. One additional disadvantage of this method of opening the envelope is that it may tend to disarrange the contents.
Another approach is to hold the stripping flaps up and then strip them down to partially open the envelope and expose its sterile contents at the top ofthe envelope. Then, the suture or surgical object may be presented directly to the surgeon for use when needed or to the sterile nurse for placing in the sterile field. The main disadvantage of this technique when utilizing prior art strippable envelopes is that the space between the stripping flaps at the apex or leading end of the strippable seal is exposed to contamination. When the stripping aps are held up and the seal is stripped down, there is a serious possibility that foreign particles and other contaminants may drop from the flaps or the edges of the seal adjacent the flaps down into contact with the contents of the sterile package.
The present invention contemplates a strippable seal envelope of the type described wherein the package may be stripped open with its aps held downward so as to avoid contaminating its contents, and which is especially constructed so that, after stripping, the envelope retains the sterile object in such a way that one end protrudes from the envelope and the other is held thereby. The contents remain completely sterile and the envelope is stripped back so that all portions of the package surrounding the contents also are sterile. Thus, the sterile object may be presented directly to the surgeon for use while held by the partially stripped envelope.
In a preferred embodiment of this invention, the envelope comprises opposed halves joined by a strippable seal enclosing a sterile object. One of the halves presents gripping means, normally in the form of a flap, beyond the seal at the front end of the envelope and the other half presents holding means, which may be in the form of an opposed ap at the same end of the envelope or in the 3,143,269 Patented Aug. 4, 1954 ICC form of side llaps. The halves are adapted to be stripped from one another by gripping the said gripping means and holding means and pulling them away from one another. In this embodiment, the retaining means is in the form of a pocket closed at the front end of the package and open at the rear end of the package. The open end of the pocket normally is closed by the strippable seal. When the package is stripped with its front end held downward so as to avoid the possibility of contamination from the flap area, the sterile object does not fall out of the envelope since it is held by the retaining pocket. The halves are stripped from one another until the sterile object is eX- posed at the front end of the pocket. Then, the sterile object is presented to the surgeon or to the sterile nurse, if normal operating room procedure is being followed, while holding it in sterile condition in the partially stripped package.
One of the important advantages of this invention is that, in an emergency, when an essential surgical item, such as a suture, is needed and this item has not been laid out on the operating room table, it may be oiered directly to the surgeon for use while held in a partially stripped package according to this invention.
In one form of this invention, a sterile surgical item such as a suture is packaged inside a second sterile envelope, or packet, which then becomes the sterile object according to this invention. In this case, the sterile packet may be presented directly to the sterile nurse by the nonsterile circulating nurse without danger of contaminating the outside of the packet.
Other and further advantages of this invention will be apparent from the following description and claims taken together With the drawings wherein:
FIG. 1 is a schematic plan view of an interiorly sterilized package according to a preferred embodiment of this invention, showing the package before opening but with the open position of the top half shown in phantom;
FIG. 2 is a similar plan view of the package of FIG. 1 when opened;
FIG. 3 is an enlarged view partly in section and partly in elevation taken along the line 3-3 of FIG. 1;
FIG. 4 is a view in perspective showing how the package of FIGS. 1-4 is stripped open to expose a sterile suture packet at the rear end of the package;
FIG. 5 is a partially cut away plan view of an interiorly sterilized package according to a somewhat diderent embodiment of this invention, showing the package closed but with the open position of the top half shown in phantom;
FIG. 6 is a somewhat enlarged View partly in section and partly in elevation of the package of FIG. 5 taken along the line 6-6 of FIG. 5;
FIG. 7 is a View in perspective of the package of FIG. 5 showing how it is stripped to expose its sterile contents;
FIG. 8 is an enlarged view in elevation of the rear end of the package of FIGS. 5-7 showing how the end of the suture packet contained therein is presented when the package is stripped and held in the manner shown in FIG. 7;
FIG. 9 is a fragmental View of a portion of a package similar to that of FIG. 5 which embodies a somewhat different form of this invention;
FIG. 10 is another partial view of the modiiication of FIG. 9, illustrating a portion of the top half or stripping portion of the envelope.
Referring to FIGS. 1-4 of the drawings, there is shown an interiorly sterilized package according to a preferred embodiment of this invention wherein a sterile suture item, not shown, is contained within a sterile primary package 11 in the form of a suture packet located inside a heat scalable strippable envelope 12. The strippable envelope is sterile on the inside but need not be exteriorly sterilized. lts contents and the contents of the suture packet may be sterilized after the strippable envelope is sealed by the utilization of an electron beam or by some other irradiating technique, or the various components may be sterilized prior to or during assembly by liquid or gaseous techniques which are well known in the art.
The heat sealable envelope 12 of this embodiment is formed of a top half 13 and a bottom half 14, or a cover portion and a base portion, respectively. These halves or portions may be formed from a strippable plastic material or a laminate thereof. For instance, Mylar coated with polyethylene has been found very satisfactory for this purpose because the Mylar provides a strong stri pable sheet and the polyethylene acts as the heat scalable component of the laminate which may be stripped open with reasonable facility to expose the contents of the envelope. The top half 13 of the envelope may be in the form of a single sheet which may be separate from the bottom half 14 or connected to the bottom half through a fold line 15 at the rear end of the envelope. If a folded sheet is used the whole envelope may be formed from two sheets of material. If a separate cover sheet is used for the top half, normally 3 sheets of material would be employed, as will be explained hereinafter.
The envelope has a front end 16 and a rear end 17 and presents a pair of stripping flaps 18 and 19 at its front end. The top and bottom halves of the envelope 13 and 14 are joined by a heat seal 21 in the form of a pair of bars 22 extending along each longitudinal edge of the envelope, a straight bar 23 extending transversely across the rear end of the envelope and a pair of inclined bars 24 meeting to form a shallow triangle at the front end of the envelope. The apex 25 of the triangle acts as the initiation point for stripping the seal. The stripping flaps 18 and 19 are formed by those portions of the sheets making up the top and bottom halves of the envelope which extend beyond the heat seal at this end of the package. Thus, when stripping aps 18 and 19 are pulled away from one another, force initially is concentrated at the apex 25 of the heat seal at this end of the envelope and then moves down the inclined bars 24 to the side edges of the envelope until the top and bottom halves are stripped apart to the desired extent such as illustrated in FIG. 4. FIG. l illustrates the envelope before stripping the seal with the top half 13 down over the packet 11 but shown in phantom to the right of the envelope as it might be stretched out after stripping; and FIG. 2 shows the top half 13 of the envelope at the same position after it has been stripped from the bottom half. Thus, in FIG. 2, the contents of the envelope are exposed.
As mentioned above, the envelope according to this embodiment of the invention is formed basically of three sheets, i.e., that used for the top half 13, that used for the main part of the base portion or bottom half 14 of the envelope,.and the sheet 28 used to form the pocket or retained portion 29 which holds the contents of the envelope in position both during and after stripping. The later sheet forming the retaining portion is coextensive with the bottom sheet except for a thumb shaped section which has been removed therefrom to provide an opening 31 for access to the packet 11 at the rear end of the envelope. The intermediate layer is heat sealed to the bottom layer in the area 32 shown in stippling in FIG. 2 thereby forming the pocket 29 with the bottom layer in the enclosed area which has not been sealed. This pocket is closed at the front end 16 of the package and open at the rear end 17. The intermediate sheet 28 is cut in such a Way that the pocket includes narrow strips 33 which ordinarily overlap the edges of the packet 11.
When it is desired to present the sterile suture packet 11 to the sterile nurse, the opposed stripping flaps 18 and 19 are gripped by the opposite hands of another attendant, the front end 16 of the envelope presenting the flaps is held down and the flaps are separated from one another so as to expose the rear end 34 of the packet at the open end of the pocket 29 at the rear end 17 of the envelope.
During this operation and afterwards, the packet 11 is prevented from dropping from the envelope since it is held in the enclosed rear end of the pocket 29. Nevertheless, the opposite end 34 of the packet is fully exposed as the surrounding portions of the envelope are removed therefrom by bending the top half of the envelope and the rear end 17 of the bottom half of the envelope down away from the packet 11. This also removes the rear end 34 of the packet 11 from the strips 33 along the side of the pocket at the rear end of the envelope. Thus, the sterile end of the suture containing packet may be gripped by the surgeon or the sterile nurse while the packet, firmly held by the remaining portion of the envelope, is presented for this purpose by a nonsterile attendant.
FIGS. 5-8 illustrate a still different embodiment of this invention wherein the base portion 14 of a similar envelope includes side flaps 36 for holding the envelope as the top half or cover sheet 13 thereof is stripped therefrom. According to this embodiment of the invention, the base portion 14 and the side ilaps 36 are formed from a single sheet of material which is folded on itself to form top and bottom sections 37 and 38 and heat sealed in such a way as to form the aps 36 and a centrally located pocket 39 for containing a suture packet. The pocket in this case is defined by two longitudinal and two transverse heat sealing bars 41 and 42, respectively, which cross one another to form an enclosed rectangular space between the top and bottom sections 37 and 38 of the base portion 14. This space is opened up to form the pocket 39 by making a T-shaped cut 43 in the top section of the base portion as shown most clearly in FIG. 5. This forms a pair of aps 44 and 45 which are adapted to be folded back at the rear end 17 of the package as shown in FIG. 7 to allow the suture packet to be removed from the envelope. The flaps 44 and 45 cannot be separated at the front end 16 of the envelope since they are joined at this end of the pocket 39 adjacent the seal line. The top half 13 of the envelope is in the form of a stripping flap which may be attached to the underside of the rear end 17 of the base portion by heat sealing a turned-under portion 46 of the top half thereto, as shown in FIG. 5. The top half 13 completely covers the pocket 39 and the packet 11 enclosed therein and is heat sealed to the base portion 14 of the envelope along lines which are substantially coextensive with the longitudinal heat seals 41 in the base portion and the transverse sealing bar 42 at the front end thereof. That portion of the top half which overlaps the transverse heat seal 42 at the front end 16 of the envelope then becomes a gripping means or stripping flap 47 for separating the two halves of the envelope to expose the packet contained therein.
When it is desired to obtain access to the packet 11, the two side flaps 36 of the envelope are held in one hand as shown in FIG. 7, the stripping Hap 47 of the top half of the envelope is gripped by the other hand, and the two halves are separated, as shown in FIG. 7, to stripthe seal along the edges of the top half of the envelope and expose the suture packet 11 at the rear end 17 of the package. The rear end of the package is constructed so that after the top half has been stripped from the bottom half the rear end 48 of the packet 11 may be caused to protrude from the pocket 39 merely by pulling down on the top half 13, as shown most clearly in FIG. 8. Thus, this end 48 of the packet 11 can be gripped easily by the sterile nurse or the surgeon.
To assure that the possibility of contamination during stripping is minimized the front end 16 of the envelopek A modication of the embodiment of FIGS. 5-8 is.
illustrated in FIGS. 9 and 10. In this form, the cove1- sheet or top half 13 of the envelope is retained in position on the bottom half by a layer 51 of pressure-sensitive adhesive applied to the underside of the cover sheet. Thus, the strippable seal is formed between the pressuresensitive adhesive layer 51 and the base portion 14 of the envelope. In this embodiment, the cover sheet 13 is integral with the bottom section 36 of the base portion so that the whole envelope may be formed from a single sheet of material.
As suggested earlier in this application, any suitable material may be used for forming the various parts of the package of this invention although plastics normally are preferred because of their cost and their transparency. The top and bottom halves of the envelope both may be formed from a metal foil, such as aluminum, coated on one side with a suitable adhesive or plastic material to allow the formation of a pressure-sensitive or a heat seal. Similarly, one half of the envelope may be a foil laminate and the other may be a plastic laminate or a single plastic sheet which in itself is heat sealable. There are a large number of plastic sheetings which are suitable for use in forming the parts of the package of this invention. In addition to the laminate of Mylar with polyethylene, referred to above, and to triuoromonochloroethylene; polyvinylchloride and other vinyl materials, rubber hydrochloride, polyethylene, itself, and various combinations of these materials may be used as single sheets or as laminates in forming envelopes according to this invention. Paper coated with a suitable pressure-sensitive adhesive or heat scalable material also may be used. In fact, all parts of the envelope may be held together by an adhesive, utilizing a pressure-sensitive adhesive to form the strippable seal, as described above. Different combinations of heat seals and adhesive seals also may be used.
Having now described the invention in speciiic detail and exempliiied the manner in which it may be carried into practice, it will be readily apparent to those skilled in the art that innumerable variations, applications, modifications, and extensions of the basic principles involved may be made Without departing from its spirit or scope` The invention claimed is:
1. An interiorly sterilized package comprising an outer hermetically sealed envelope and an interiorly sterilized suture packet within said envelope, said envelope comprising a base portion and a cover portion joined by a strippable seal, said cover portion having gripping means adjacent one end of the strippable seal at the ont end of the envelope for separating the cover portion and the base portion and thereby stripping said seal, said base portion having holding means for gripping the base portion as the cover sheet is separated therefrom, the base portion having a retaining portion forming a pocket normally closed by said cover portion and holding the suture packet in position on the base portion after the cover portion has been stripped therefrom to open the pocket and expose the end of said object nearest the rear end of the envelope, said retaining portion comprising side strips overlapping the side edges of said packet and yieldingly engaging said side edges for minimizing the likelihood of said packet being displaced from said pocket, and defining a T-shaped opening for removing the packet from the pocket.
2. An interiorly sterilized package according to claim 1, wherein the gripping means on said cover portion and the holding means on said base portion are in the form of opposed stripping iiaps.
3. An interiorly sterilized envelope according to claim 1, wherein the holding means on said base portion are in the form of ilaps connected to the side edges of said base portion.
4. An interiorly sterilized envelope according to claim 1, wherein the strippable seal is a heat seal.
5. An interiorly sterilized envelope according to claim 1, wherein the strippable seal is a pressure-sensitive adhesive seal.
References Cited in the Ele of this patent UNITED STATES PATENTS 2,410,438 Fields Nov. 5, 1946 2,735,544 Guyer Feb. 2l, 1956 2,806,593 Abbott Sept. 17, 1957 2,993,589 Zoller et al July 25, 1961