US 2615565 A
Description (OCR text may contain errors)
Oct. 28, 1952 J. 0. BOWER ETAL 2,615,565
SUTURE PACKAGE AND METHOD Filed Jan. 9, 1947 35 INVENTORS john O. Bower Johm P. Tarbo Patented Oct. 28, 1952 SU'VIURE PACKAGE AND METHOD John 0. Bower, Wyncote, and John P. Tarbox, Philadelphia, Pa.; said Tarbox assignor to said Bower Application January 9, 1947, Serial No. 721,100
7 Claims. (01. 206-'-63.3)
Our invention relates to a suture package adapted to contain or containing a suture of any of those many varieties and materials utilized by surgeons in connecting together tissues of the human body as needful in their operations or the practicings of their profession. Such sutures are most commonly comprised of catgut, but there are also used at different times and for various special purposes sutures of silk threads or metal wires. I
The suture package in most common use is most commonly comprised of a tube or vial containing the suture around a rectangular card or other core piece, the tube being filled with a sterilizing and preserving liquid such as xylene and hermetically sealed. Each the tube, xylene, and the contained sutures and core'piece are all thoroughly sterile at the time of their'assembly together and the glass tube being hermetically sealed they are kept sterile.
Such a package to begin with is of a relatively difficulty handleable shape, and is fabricated by the manufacturers of these products through rather numerous manual operations and at relatively high cost. Due to the shape of the package and its fragile character it has to be specially boxed and its handling during shipment must be under special care. This, too, becomes relatively costly.
The use of the package by the hospital staff and the surgeon is attended with considerable bother and inconvenience. The glass tube or vial is either boiled or placed in bactericidal solution and then crushed in a thick towel to prevent the cutting of hands and the scatter of glass and liquid. The suture, being removed with its core piece, is boiled at relatively high temperature in sterilizing liquid jointly to remove from it the adhering xylene which is irritating to wounds, to additionally insure sterilization, and to soften the suture so that when unwound from the core piece the sharp zig-zag bends can be smoothed out by the surgeon and the thread will be free from angularity during use. All of these things are routine, but viewed as a whole are seen to be lacking in high practicality. Sometimes it is found that the chromic or other suture coating has been ruptured at the sharp bends around the card.
The objects of our invention are to remove these impracticalities of manufacture, shipment, handling, and use, to lower the expense of packaging, to reduce the volume required for the package, to make the package as a while more readily manipulable, to markedly increase the facility and convenience of use by the hospital staff and the surgeon, all without detriment to the maintenance of complete sterility of both the suture and the package at any time from the original sterilizing of the suture to its final use upon the patient.
We attainour ends by embodying a suture package as a substantially flat form envelope encompassing a suture coiled in fiat form and hermetically sealed about it. Preferably, we comprise the envelope of two complemental parts of substantially flat plate-like parts made of molded dielectric material, such as glass or plastic, preferably the latter, having peripheries adapted to be hermetically sealed together through heat generated by dielectric stress under pressure. Adjoining the peripheries we provide space to receive the fiat coiled suture by offsetting the inner surfaces of the parts from each other, preferably in the form of an annular groove. We place the coiled suture between the complemental parts before sealing them together, and thenseal them together leaving a nipple through which the contained air or other gases may be exhausted and the suture containing space'left in vacuum. Sealing in a vacuum we have found of especial advantage for sutures coated with hemoglobin solutions. Alternatively, We assemble the complemental parts and suture together in an atmosphere of thoroughly sterile air and hermetically seal such thoroughly sterile air as is contained within the spaceduring assembly within the pack age along with the sterilized suture.
To facilitate breaking of the package and assure sterility for use we provide the complemental parts with an inter-part recess beyond the hermetic seal into which a sharp pointed tool may be inserted and used-as a wedge :or a lever to force the two complemental parts apart by breaking the hermetic seal between them.
The suture package which we use to attain our ends involvesmethod as Well as structure. According to the method component, of our invention we first thoroughly sterilize both the complemental parts of the envelope Comprising the package and the suture to be contained by it. Either before or after the initial sterilizin operation upon the suture we coil the suture in flat form of properdia'meter to be received in the envelope and tie it in flat coil form, maintaining sterility during the coiling and tieing. Then in a sterile atmosphere we lay the fiat coiled suture within the offset of one of the sterile complemental parts provided to afford space accommodation for it between the parts. Thereupon the complemental part of the envelope is placed upon the one and preferably sealed to it. If the envelope is to be vacuumized an opening is left for connection with the vacuum apparatus (as through the nipple) and the container is then connected to the vacuum apparatus and vacuumized, whereupon the opening is sealed.
If the vacuum is not to be used, but thoroughly sterilized air introduced to the space occupied by the suture, the hermetic scaling is done in a thoroughly sterile atmosphere, and the entire periphery sealed up at one and the same time, whereby whatever sterile air is contained within the suture space is completely sealed in. In this modified package and method we introduce the step of assembling the package and sealing it under ultraviolet light of such intensity as to attain and maintain thoroughly sterilized atmosphere within a closed room within which the assembling and scaling is done, and the further step of accomplishing the hermetic sealing by heating of the dielectric material of which the parts are made by dielectric stress applied to the peripheries while they are being forced together under pressure.
In the accompanying drawings and the following specification we delineate and describe each of several of the various embodiments of our invention now known to us, those which we so delineate and describe being those which weconsider at this time to be of greatest utility.
Referring to the drawings,
Figure 1 is a side elevation of a form of our invention adapted especially for embodiment in glass. This form is especially suited for a vacuum package. Y
Figure 2 is a transverse cross section of this form taken on line 2-2 looking in the direction of the arrows on Figure 1.
Figure 3 is a transverse cross section of a modification of the form of our invention shown in Figures 1 and 2, the modification adapting it for hermetic sealing under heat generated through dielectric stress, and while suited for embodiment in glass, is more especially suited for embodiment in molded plastic material such as transparent Lucite (a thermoplastic methyl methacrylate resin) or the like. This modification, like its parent form that of Figures 1 and 2 is primarily suitedfor a vacuum package.
Figure 4 is a transverse section of the modification of Figure 3, picturing the package as complete and vacuumized, but about to be broken by a suitable tool.
Figures 5 and 6 are respectively plan and transverse cross sections on line 6-5 of Figure 5 of a form the more especially adapted for embodiment in transparent molded plastic material in which the suture containing space is reduced to a very small volume, while the package itself may be extremely fiat and yet of more rugged construction than the form of Figures 1 to 4.
Figure 7 is a transverse cross section of a slight modification of the form of Figures 5 and 6, one in which the offsets providing the suture containing space are provided in one of the complemental parts only, the other part being substantially flat.
Figure 8 is a similar transverse cross section of a similar modification of the former Figures 5 and 6, one in which the suture containing space is reduced to a veritable minimum and the fiatness is extreme.
Referring now to the drawings, it is pointed out that throughout the several embodiments and the several figures in the drawings in respect to them we have designated the relatively flat form envelopes which contain the sutures as 20, the relatively fiat form complemental parts of glass or plastic of which the envelope is comprised as 2i and 22, the flat coiled sutures which they contain as'23, the needle of the suture as 24, the offsets of the inner surfaces of the complemental parts 2| and 22 which lie adjacent the peripheries of the parts and afford the space within which the suture lies as 25, the hermetic seal between the complemental parts 2! and 22 as 26, the vacuum tip or nib as 21, and the package opening recesses as 28.
The form of Figures 1 and 2 adapted especially for embodiment in glass might be termed a watch case form. The complemental parts 2! and 22 are shallowly convex like the back and front cover of a watch case or like two watch crystals placed edge to edge. The diameter is from 1 /2 inches to 2% inches, depending upon the size desired to receive the flat coiled suture 23 and its needle. The complemental parts 2| and 22 and the suture 23 and the needle 22 having all been thoroughly sterilized, are assembled together by first placing the suture in the one half, let us say 22 where it is received by the offset 25 in that part, and thereby approximately centered within the envelope, whereupon while maintaining the sterility by any known means, the hermetic seal 26 is carried out by heating and welding the edges together by a glass blowing process or other. The nib or tip at this step is open. It is thereupon connected to a vacuum machine and all air or other gas within the envelope exhausted whereupon the nib or tip 21 is sealed as shown. Complete sterility of the interior of the package and the suture is thus preserved until the time for use has arrived.
In use the nib or tip 21 is broken off, thus breaking the vacuum. Thereupon the package may be broken open by inserting a sharp pointed tool within the opening so made and breaking the envelope 20 away from the suture 23. Alternatively, the envelope may be cracked under a cloth or towel simultaneously breaking the main body of the envelope 2!! and enabling the suture to be removed.
In the modification of this form shown in the transverse cross section of Figure 3 the showing is of an assembly partially completed with the seal 26 in process of being made. The suture 23 and its needle 24 have been introduced to the one part, say 22, the other part 2| has been complementally placed upon it, and the seal 26 between their meeting peripheries is illustrated as being made by the application of heat generated byldielectric stress, while the parts are being forced together under pressure. To facilitate this method of hermetic sealing the periphcries of the complemental parts 2! and 22 are provided with complemental flanges 29 adapted to be sealed together by pressing them together firmly while subjecting them to heat sufficient to melt the faces together, or else melt a plastic glue or cement binder with which the meeting faces of the flanges are provided as well known in the art of gluing or cementing of plastics. Dies 30 are shown through which this pressure is applied and through which dielectric stress to generate the necessary heat is simultaneously introduced. Such a method is shown and described in U. S. Patent No. 2,205,582.
To adapt this form of our invention to vacuumizing like the parent structure of Figures I and 2 we introduceatonepoint in the periphery during the assembly a small tube 3| to constitute the nib or tip 2'! when sealed in place. Semi-circular diversion of the flanges '28 at this point borne :upon by semi-circular notches in the dies 3!! enable one to effectually seal this tube in place at the same time as the main bodies of the flanges 28 are sealed together. Vacuummay then be obtained through the tube 3| constituting the nib or tip 21 and the tip sealed off.
A transverse section of the package completed in this manner is shown in Figure 4.. If comprised of glass it may be most effectually opened in the manner described with the parent form of Figures 1-1 and 2, by breaking oif the nib-.21 to break the vacuum, and. then breaking the envelope 20 in its main body. If, however, comprised of transparent plastic mat'erial (such as Lucite or any of the molded plastics of suitable-constituency and strength) the package may be the more cleanly and eiIectually opened by inserting a sharp pointed tool 32 (such as a screw driver; knife blade, forceps or scissors) in the recess 28 formed between certain portions of the .fianges- 29 and wedging or lever prying the two complemental parts 2| and 22 to break the seal 26 and separate them from each other. Tothis end we contemplate making the seal 23 of no greater strength than is requisite to maintain the hermetic seal unimpaired during the normal handling of the package after completion in the factory, in transit, in storage, and at the time of use. In other words, the-seal, while hermetically perfect, does not require to break it apart between the flanges '29, that is to say, in'the plane of joinder, a force greater than that which can be readily exerted by any person needing to open the package. While the embodiments of the invention illustrated in Figures '1 to 4 are especially adapted for vacuum preservation of sterility, obviously they are equally adapted for preservation :insterile gas. The modified method of our invention consists in carrying out the assembly and sealing operations described and illustrated, especially the hermetic sealing as illustrated in Figure 3, in a thoroughly sterile atmosphere, and as such portion of that atmosphere as is trapped within the envelope 26 during the hermetic sealing operation is finally sealed therein by the sealing of the end of the nib or tip 21 the sterility is maintained through the presence of this atmosphere rather than through the existence of a vacuum.
The modifications of Figures 5 to 8 are especially adapted for the practice of this latter modification of our method of assembly, to wit, assembly in a sterilized atmosphere, and the maintenance of sterility through hermetic sealing of this atmospheric only in the envelope space occupied by the suture. Yet anyone of these several forms of Figures 5 to 8 may be adapted to the first method, the preservation of sterility by vacuum merely by providing also an appropriate opening, as for example, that through the .nib or tube. 21 for the exhaustion of the air from within the envelope and its subsequent sealing. For brevitys sake showing of such a nib has been omitted from any of these Figures 5 to 8.
In the form of Figures 5 and 6, instead of forming the ofisets 25 like watch case halves or crystals of over-all convexity, the ofisets 25 are of acute convexity, constituting grooves adjoining the peripheries of the disk-like, substantially fiat complemental parts 21 andazlot the envelope 2.0. In thispform. eachv part; 21, and '22 is so offset, there being formed thereby an annular suturecontaining groove. of substantially circular. cross section. Leading oil from the annular offset 25' needle were curved, subordinate offset 33 would becorrespondingly curved to accommodate it and lead from the oifset 25 tangentially. If the curvature of the needle be on a radius equal to the radiustof the annular main offset 25 the needle can be accommodated within the groove of this main oifset, thereby avoiding the necessity for a subordinate offset, such as '33. Preferably, one of the complemental parts, such as 22, omits offset 33 whereby its mid-portions are fiat. These mid-portions meet the intermediate fiat portions of the complementalpart 21 as shown. The flat face 34 of the complemental part 22 provides admirably for space for the attachment of a label 35.
The modification of the form of Figures 5 and 6- shown in transverse cross section in Figure "7,
embodies the offsets 25 like offset 33 in but the sets 25 and 33 and the omission of any corre sponding'oifset in 22. t
Figure 8 isv a, still further modification of this form of Figures. 5- and 6, the fiat form being made still flatter by laying all of the turns of the coil to but a shallow depth the offsets 25 and 33 to accommodate the plane form coil 23 and needle 24. Thus it becomes the fiattest and thinnest package of all with the veritable minimum of suture accommodating space. in the case of Figure 7, the one part 22 is of plane form, while the offsets 25 and 33 are confined "to themeeting part 2|.
In each of these modifications of Figures 5 to 8 an inter-part recess 28 for the opening of the package is provided. As clearly appears in Figure 5, this recess lies in between ear-like widened portions 36 of the flanges 29. In each form the seal 26 is made between flanges 29 by the same method as that described in connection with Figures 3 and- 4..
The package of our invention is outstandingly adapted for the marketing of sutures coated with a hemoglobin solution such as disclosed in the copending patent application of John O. Bower No. 502,503 filed September 15, 1943, now Patent 2,493,943 dated January 10, 1950. In fact, a suture so coated forms a component-part of our suture package as completed.
According to a further modification of our invention instead of vacuumizing our container or sealing sterilized air within it we may fill the space within the container and about the suture with xylene, alcohol, or other preserving liquid as is now the common practice. In such case the container would be made of glass or plastic which is unaffected by these preserving liquids.
Any of the packages disclosed may be enclosed if desired in an outside protective envelope of This offset In this case, as"
-Cellophane or other "transparent ma'terial of' this general class which is sealed aboutthe pack age. This outside envelope may be of any form but is preferably rectangular and it may itself be sealed hermetically thus afiording an extra hermeticsealing which will'multiply the protec tion afforded by the inner envelope of the package per se. By sterilizing the external envelopes, the packages per se may then be sterilized externally and maintained so until the external errvelope is removed. 2:.
Obviously, there are possible many other em, bodiments of our invention, without in any Wise' departing from its generic spirit, embodiments involving variations both in structure and? in" method. Accordingly, irrespective. of the fact that we do not at this time know of all such embodiments which are possible, and because of the:-
fact that this lack of complete such knowledge precludes the best possible choice of terminol'oglsl, the annexed claims are to be interpreted in such fullness of the generic spirit of our invention that the invention in its generic spirit shall be protected to us, irrespective ,of the circumstantial terminology used. What we claim is: v l s 1. A suture package of disklike configuration, said package comprising two complemental abutting disk-like elements at least one of which is provided with a convex suture-housing offset, said complemental elements being composed of relatively rigid thermoplastic material and being circumferentially bonded to each other by fusion of such material along an annular juncture line, said complemental members further being provided with opposed rigid fulcrum means lying in the general plane of the package and projecting radially beyond the juncture line for prying said members apart, said package further containing a surgical suture within said convex offset. 2. A flat suture package comprised of two congruent generally flat elements of relatively rigid material, at least one of which elements is provided with a planar sealing flange registering with the other element along a peripheral sealing line common to both; and at least one of which elements is provided with a lateral suture-receiving offset; said package having an hermeticallysealed, frangible nipple projecting beyond the said peripheral sealing line, and communicating with the space enclosed by said offset said package further containing a coiled surgical suture, and being hermetically sealed throughout.
3. A suture package of disk-like configuration, said package comprising two complemental abutting disk-like elements at least one of which is provided with a convex suture housing ofiset, said complemental elements being composed of relatively rigid thermoplastic material, and at least one of said elements being provided with a planar sealing flange configured to register with the other element along a peripheral sealing line common to both, said package being provided with a sealed nipple projecting beyond the said peripheral sealing line and containing a surgical suture stored in a gas at subatmospheric pressure.
1 4. The method of packaging a suture which consists in placing a coiled suture in an annular chamber formed in a plate-like member of relatively rigid thermoplastic material, placing a second plate-like member, congruent with the first, above the first member, and applying dielectric stress to bond said members together along a peripheral sealing line common to both but leaving matching portions of each member extending outside of the sealing line to afford fulcrum means for breaking the seal and prying said members apart.
5. The method of packaging a suture which comprises the steps of forming a pair of congruent generally flat container parts with a convex recess in at least one of said parts to house a coiled suture, placing a coiled suture in said convex recess, placing the two parts in juxtaposition with a nipple interposedbetween them, said nipple communicatin with said recess and projecting beyond the margins of said parts, pressing the parts together, evacuating the recess, and sealing the nipple.
6. The method of packaging a suture which comprises the steps of forming a pair of congruent generallyfiat container parts with a convex recess in at least one of said parts to house.
a coiled suture, placing a coiled suture in said convex recess, placing the two parts in juxtaposition with a nipple interposed between them, said nipple communicating with said recess and projecting beyond the margins of said parts, heatsealing the parts together, injecting a sterile fluid into said recess through said nipple, and sealing the nipple.
7. The method of claim 6, in which the sterile fluid is an inert gas. 7 JOHN O. BOWER. JOHN P. TARBOX.
REFERENCES CITED The following references are of record in the file of this patent:
UNITED STATES PATENTS Number Name Date 1,357,128 Travas Oct. 26, 1920 1,914,836 Randall June 20, 1933 1,962,900 Hirsch June 12, 1934 1,970,193 Riebel, Jr. Aug. 14, 1934 1,997,443 Waugh Apr. 9, 1935 2,006,212 Grabler June 25, 1935 2,035,803 Gilardi Mar. 31, 1936 2,103,389 Salisberg Dec. 28, 1937 2,142,707 Austin Jan. '3, 1939 2,205,582 Steimel June 25, 1940 2,210,017 Wetherby- Williams et a1.- Aug. '6, 1940 2,334,600 Boysen Nov. 16, 1943 2,358,246 Nicolle Sept. 12, 1944 2,377,118 Weisman 1 May 29, 1945 2,434,330 Merz et a1. Jan. 13, 1948 FOREIGN PATENTS Number Country Date 107,304 Australia Apr. v28, 1939 184,947 Great Britain Aug. 31,-.1922 463,844
Great Britain Apr. 7, 1937