US 2318379 A
Description (OCR text may contain errors)
y 1943- w. s. DAVIS hm. 2,318,379
SUTURE PACKAGE Filed April 17, 1941 2 Sheets-Sheet 1 iflalie s. paddy Czar/es jipadeis' May 4, 1943. w. s. DAVIS ETAL summn mam:
Filed April 17, 1941 2 Sheets-Sheet 2 mm mm.
ture may be immersed Patented May 4, I943 2,318,379 SUTURE PACKAGE Walter S. Davis, San Bernardino, and Charles T. Davis, Los Angeles, Calif.
Application April 17, 1941, Serial No. 388,948
The present invention relates to suture packages and is a continuation in part of our prior application, Serial No. 284,388, filed July 14, 1939, for Sutures and methods of packaging and sterilizing the same.
Our prior application is now directed particularly to the process of producing a sterilized and packaged suture, while Patent No. 2,253,287, issued August 19, 1941, and the present application is particularly directed to the products or packaged sutures which are made according to the process covered by said application or patent.
One of the objects of the invention is the provision of an improved suture package by means of which the suture is preserved in a sterile condition for a very long or indefinite period of time, until it is to be used, and by means of which the suture is maintained in the best possible condition for use.
Another object of the invention is the provision of an improved suture package embodying a suture contained in a frangible tube, which tube is adapted to be broken easily and cleanly at a predetermined point with a minimum possibility of danger of accident, so that the suture may be removed and used most expeditiously.
Another object of the invention is the provision of an improved suture package which is equally adaptable for use in packaging all kinds of sutures of either the boilable or non-boilable type.
Another object of the invention is the provision of an improved suture package in which the suin alcohol or another suitable sterile liquid and carried by a reel or spool, and in which the suture may be retained at that end of the tube which contains the alcohol. While it may be true that the space above the alcohol may be saturated with alcohol vapor which may have the suture, for commercial reasons, it is highly desirable that the sutures be retained all at the same end of the tube in the alcohol to provide a more salable product.
Another object of the invention is the provision of an improved suture package having a reel which minimizes the possibility of the tangling of the coils of the suture, or the possibility of the suture getting between the parts of the reel and preventing the withdrawal of the reel or spool from the tube when the suture is to be used.
Other objects and advantages of the invention will be apparent from the following description and the accompanying drawings, in which similar characters of reference indicate similar parts throughout the several views.
an equal preservative effect on.
Referring to the drawings, of which there are two sheets:
Fig. 1 is a view in perspective, partially broken away, of a box containing a dozen of the packaged s'utures which have been treated and packaged according to the process of my prior patent, the box being broken away partially to show the structure of the box and tube;
Fig. 2 is an elevational view of a suture packaged in a tube according to the process of my prior patent;
Fig. 3 is an elevational view of one of the glass tubes and the bacteria-proof plugs which are used in the process of packaging the suture;
Fig. 4 is a fragmentary sectional view taken through that part of the glass tube which has a constriction in it and which also has the wall of the glass made thinner at the constriction by grinding, etching, or otherwise;
Fig. 5 is an elevational view of an intermediate product made in the process of packaging sutures comprising the tube, a spool, a suture and. a bacteria-proof plug, all arranged so that the tube can be, sealed between the plug and the suture;
Fig. 6 is a view similar to Fig. 5 of a modified product which may be the same except for the fact that the plug has been cut oif flush with the top of the tube for reasons to be described in detail;
Fig. -7 is an elevational view of an improved reel or spool upon which the suture may be wound and which ha the advantage that the possibility of tangling or of the suture getting in between the parts of the reel is reduced to a minimum;
Fig. 8 is an elevational view of the reeled suture of Figs. 6 and 7;
Fig. 9 is an exploded view other modified form of reel;
Fig. 10 is the assembled view of the parts of the reel of Fig. 9; a
Fig. 11 is an elevational view of another form of reel adapted to be broken at the middle; and
Fig. 12 is a vertical sectional view showing the reeled suture as it appears in the tube after the tube has been broken, taken. from the right side of Fig. 6 looking in the direction of the arrows.
-Referring to Figs. 7 to 11, these are views showing the various types of reels for supporting the sutures in the tubes. These reels are preferably made of indurated fiber or other neutral rigid V material adapted to withstand heat and adapted of the parts of an- I.
Fig. 9, the reel preferably comprises two similar parts 26 and 2|, comprising flat pieces of indurated fiber which are substantially rectangular in shape, except for a longitudinally projecting finger 22-25 at each end of each part 20 or 2i.
The two parts of the reel 20 and 2| are identical laid one upon the other but oppositely disposed,
as shown in Fig. 10, the assembly is a flat member having a groove 26, 29 formed at each end. This groove is formed by virtue of the fact that the fingers 25-25 have a width which is only a fraction of the total width of the strips 20, 2|. The suture may then be coiled by wrapping it about the reel of Fig. in a relatively loose manner s: that the outer ends are curved with an easy curve, as it is not desirable to draw the sutures tightly about the reels to form kinks or angles in the suture. When a suture is thus loosely coiled about the reel, it may be placed in one of the tubes when the tube 21 is in the form of Fig. 3, the cotton plug being first removed. The coiled suture will then expand into the bulbous space below the constriction 26 and will tend to retain the suture and reel at the lower end of the tube. This is highly desirable in order to make a more salable product which is always uniform in appearance, but it is also absolutelynecessary that the suture be kept out of the way and spaced from the upper end of the tube when the-tube is to be sealed below the cotton plug and put into the final form of Fig. 2.
Referring to Fig. 11, reel in which the reel is made of one piece of indurated fiber comprising a substantially rectangular strip formed with rectangular slots or grooves 28, 29 at each end. In all of these reels the fingers 22-25 preferably have their ends rounded for the purpose of eliminating sharp corners. In this embodiment, the reel 30 is provided at its middle or between its ends with a plurality of perforations 3|, the perforations being arranged in a row and close together so as to weaken the middle of the reel. The suture may then be removed from this reel by merely breaking the reel in two. and slipping each of the halveslaterally out of the coiled suture.
In the embodiment of Fig. 10, the suture is removed from the reel y p in the wo a this is another form of in shape, but oppositely disposed, and 34 and 35 differ from reel parts 20 and 2| of Fig. 9.in that there are fingers 36, 31 and 33, 33 at the right end of each of the strips 34 and 35. Thus, the right end of each of these strips is formed with a groove 28 which will retain the 'suture between the fingers 36, 31 and 36, 33 without any possibility of the coils of the suture getting between the fiber sheets.
The right end of this reel of Fig. 8 is the one which is disposed at the bottom of theglass tube 35 may be formed exactly like the left end of the parts of the reel in Fig. 9, as there is no danger of such an occurrence at the top of the reel.
In this embodiment the reel is assembled by placing the two parts 34 and 35 upon each other, as shown in Fig. 8, to make the reel 33, after which the suture may be coiled on the'body of the reel inside the grooves 26 and 23 in a loose manner so that there will be easy curves or bends at the upper and lower parts of the coil. It should be noted that the suture 46 is not drawn tightly against the bottom of the groove as shown in Fig. 8, thus indicating the loose character of the coiling of the suture about the reel.
The reel of Fig. '7 is taken apart by separating the two parts 34 and 35 after the manner shown in Fig. 7. After this has beendone, the part 34 or 35, which does not carry a coil at its left end, may be withdrawn longitudinally so that its groove 28 will be removed from the coil. Then the coil will be resting only on one part 35 from which it may be removed by lifting it off the finger 24. The suture is unreeled by merely grasping the upwardly projecting end of the suture which is always permitted to project upwardly from the reel, as indicated at 43 (Fig. 6).
Referring to Figs. 3 to 6, these are views showing the glass tube which is preferably used for packaging the sutures. This glass tube is usually made with a round bottom and with an open upper end. But it should be understood that flat ended receptacles may also be used and tubes of other material which are capable of being sealed between the cotton plug and the suture without removing the plug may also be employed.
The tube 21 is preferably provided with a constriction; that is, a diminlshment of size on the outside of the tube which is also evidenced by a smaller diameter on the inside of the tube, as indicated at 26 (Fig. 4). The tubes are-preferably cylindrical in shape and various sizes of tubes may be used. The utilization of the conparts 26 and 2| of the reel from the position'of Fig. 10 to that of Fi 9. suture may be slid oil thebody of thereel.
Referring toFigs. '1 and 8, these are views after which the coiled showing the preferred form-of reel. It has been found that with the reels ofv the type of Figs. 9 and 10, the coils of a suture sometimes get out of the groove 26 at the lower right-hand corner and down in between the two pieces of cardboard 26 and 2| at the point 32. While this happens .only infrequently, when it does it may be the source of considerable difiiculty for the surgeon or attendant, and it is the purpose of the reel of Figs. 1 and 8 wholly to eliminate any possibility of such an accident.
Thus the two parts of the reel 33 of Fig. 8 are indicated at 34 and 35. They are identical striction 26 enables the use of a larger size of tube while still permitting the use of a constriction which can be broken cleanly and squarely across by means of the hands. For example, the tubes average 11 mm. in diameter onthe outside, varying from 11% to 11% mm. in size. The depth of the groove in the tube which is produced by means of heat and rollers applied to the glass tubes may be mm. more or less, and this diminishes the total diameter of the tube at the constriction by approximately 1% mm. In addition to the rolled groove or constriction 26, the tubes 21 are subjected to a grinding by means of a carborundum wheel with a rounded edge or by any similar abrasive, and a band 44 of predetermined width is preferably ground all the way around the tube at the constriction 26 on the outside. This band appears on the outside of the tube in the form of a white 21. The other end of the fiber sheets 34,
sterile forceps 'or sterile fingers.
portion of ground glass, as distinguished from the rest of the tube which is transparent. The result of this grinding is that the thickness of the tube is also diminished at the point 45, so as to weaken the tube further for the purpose of facilitating its breaking squarely across at In some embodiments of the invention the grinding of the band 44 may be made only on one side which would be the side subjected to tension in the bending of the tube for breakage.
Such a tube may, however, be placed in a towel and the force of bending applied to it with the hands on the outside of the towel. When that is done, it is difficult. to observe which side has the ground glass groove, and therefore it is preferable to grind the glass to a lesser thickness all the way around the tube.
It will thus be observed that the tube not only has a constriction which makes it smaller and easier to break at the point 26, but the wall is made thinner on all sides so that when a bending force is. applied to the tube it will break oil squarely and cleanly, as shown in Fig. 12.
The grinding of the wall of the tube thinner by means of an abrasive wheel or otherwise is not to be confused with file cuts, glass cutter cuts, diamond cuts, steel saw cuts,'or cracks, because the latter arrangements are dangerous in that they represent the beginning of a crack which may cause the tubeto break at any time during process of manufacture or shipment. According to our invention, the wall of the tube is made thinner without any crack being produced, and thus the tube is not subject to breakage by shock but may only be broken by application of a suitable bending force at the proper point.
The use of the constriction also enables the retention of the coil of gut in the lower part of the tube, as the coil expands below the constriction in the manner shown in Fig. 12. The constriction is-preferably made at such a point that the spool projects only-enough to be grasped by The free end of the gut also projects above the constriction 26, as indicated at 43, so that it' can be grasped to uncoil the gut. There is no tangling or hunting for the free end. The surgeon or attendant is able to find the free end of the gut to thread it into the needle at once.
In some embodiments of the invention such as that exemplified in Fig. 5, the constriction may be used without the abrasive scoring of the tube which produces the thinner wall. The suture which is included in the tubes so far described is preferably the product of a closed system of treatment and sterilization as described and covered by our prior patent above mentioned.
Although the term ligature" has been used for a prepared string of catgut utilized for tying parts or tissues in surgery, and the term "suture" such as toluene or xylene, or it may consist of a non-boilable suture preferably preserved in ethyl alcohol.
The gut string or catgut of suitable size is strung upon a tanning frame with the individual strands separated and immersed in a suitable chrome tanning bath until the suture has received the desired amount of chrome tanning, this process being called chromicizing.
The suture is then preferably partly dried and it is wound upon a reel of one of the types described herein made of hydrated cellulose, also known'as vulcanized fiber or intimated fiber. The fiber is preferably of the white variety, although diifrent colors may be used and may be employed as a means for indicating the type of suture in a given package. The coiled and reeled suture is then placed in the glass tubes which have been previously thoroughly'cleaned and sterilized.
The glass tubes are provided with the constrictiondescribed in the course of their manufacture, and they may be provided with the external scoring which makes the thinner wall at the constriction at the time of their manufacture or after the suture has been inserted. The insertion of the suture is accomplished by means of a small tool having a slot in its end for engaging and supporting the reel, whereby the reel may be pushed to the bottom of the tube.
When the coiled suture is inserted, its loose coils expand into the space below the constriction 26 to retain it in the lower part of the tube.
A label indicating the type and grade of surgical gut may also be inserted in the tube surroundhas also been employed in the' art to describe a the same product when it is used for sewing or aged are tendons. horsehair, lk. linen. cotton.
wool, silver wire, stainless steel wire, etc.
As described in our prior patent, the suture product in the package may consist of a bciiable suture preserved in an anhydrous organic liquid,
ing the suture, label on which there is printed the data necessary to an indication of the kind of gut.
The open end of the tube is then closed against ingress of microorganisms with a porous plug,
indicated at 50 in Fig. 3. This plug is preferably a rolled and compressed plug of cotton which may be approximately of an inch or more in length in that portion which is inside the tube.
If prepared in the best manner, the end of the tube will be quite tightly filled with the cotton plug in such manner that the passage of microorganisms is practically impossible as long as the plug is undisturbed and not penetrated by any instruments or nonsterile liquids.
In some embodiments of the invention the plug 50 has the protruding bulging portion 5| at its top outside of the tube 21, in addition to the cylindrical portion 52 inside the tube, as shown in Fig. 3.. In the preferred form of the invention, however, this protruding portion 5| is cut oil with a sharp instrument, such as a razor blade or other tool, so that its upper surface 53 is flush with the top of the tube, as shown in Fig. 6.
This is of considerable importance in the saving of a sterile preservative fluid of a combustible nature, such as alcohol, because there is a certain point in one form of the process at which the alcohol which has been absorbed by the plug 50 is either burned off or dried out by other means, so as to remove the alcohol from the plug. If the protruding part of the plug is cut oil there will be less alcohol absorbed and, less to be burned oiT or dried out. I
In some embodiments of the invention, the suture in the plugged tube may then be sterilized by the application of heat in a suitable oven for a predetermined period of time suflicient to ki1l such as for example a white paper container, the
- are not to be transported any bacteria and their spores. For example, the sterilization may be carried out at a temperature of from 275 to 330 Fahrenheit for a period of from one to five hours or more. If the sutures are not to be transported or preserved in a preserving liquid and are to be used in the immediate locality, then the completion of this sterilization may result in a product which is ready for use.
In other embodiments of the invention, the suture is subjected to the action of a vacuum at the same time that the sterilization is carried on in order that all of the. water vapor which is evaporated from the suture may be carried off, because the absence of moisture is essential to prevent the collagen of the catgut or other suture material from being converted into gelatin under the influence of heat, as such conversion would otherwise render the suture brittle and weak. The sutures which are subjected both to sterilizing heat and vacuum are flexible and .strong, and when they are preserved in ethyl alcohol such as that which can be purchased on the market, the small percentage of water in this alcohol may again be absorbed by the suture to improve its flexible condition.
The packaged suture comprising the glass tube suitably plugged and containing a coil suture which has been subjected simultaneously to steriiizing heat and vacuum to remove all of the moisture is another intermediate product in the process which has marked advantages, and
may be used in the form which it has at the end of this step of the process. j
In the preferred embodiment of the process, the vacuum is then broken and the sterile preserving fluid, such as ethyl alcohol, is drawn or forced into the airtight container in which the suture is sterilized until the open end of the tube is covered or immersed in this liquid.' It should be understood that a large number of tubes containing sutures are preferably processed simultaneously, the tubes being supported in racks or jars and the racks or jars being placed one above the other.
In some embodimentsof the tubes might be placed in horizontal position so invention, the
that a lesser amount of alcohol is required to immerse the end of the tube.
When the container for the tubes has a suitable amount of alcohol in it, the supply of alcohol is shut off and a vacuum is again produced in the reduction of air pressure in the container causing air to bubble out of the tubes through the closure plugs, the bubbles passing up through the liquid to the free surface of the liquid, The degree of vacuum applied at this time has a direct relation to the amount of liquid that is to be placed in each tube.
In the next step the vacuum is again broken andsterile air admitted to the container and the reduced-pressure existing in the tubes causes the alcohol in which the end of the tube and the plug is immersed. to filter through the plug into the tube in a predetermined amount, filling all of the tubes to substantially the same level irrespective of the position of the tubes in the liquid.
In some embodiments of the invention, the intermediate poduct resulting from the process at the end of this step may be the subject of immediate utilization, particularly when. the sutures for any appreciable distance.
It will be noted that the tubes 21, which are" used, have a substantial length of tubing between the constriction 26 and the plug 50, and both the suture and the liquid are located in the lower part of the tube so that this extra length of tubing is available to be used in eifecting a seal between the plug and the suture or liquid without removing the plug. If the excess alcohol is not dried out of the plug before sealing the tube,
it will bevaporized during the applicationof heat to the tube and will cause the formation of bubbles of glass and render the sealing of the tube diflicult. Therefore, the excess alcohol is dried out of the plugs at this time, and this may be accomplished by permitting the tubes and plugs and contents to stand in a drying atmosphere for a predetermined period of time 01 by touching a match or otherwise igniting the alcohol on the Plugs so that it will burn off.
The tubes are then preferably sealed between the suture and liquid and the plug by. the application of heat, the tube being drawn out until its cross-section narrows, and finally the two parts of the tube are severed without either of the adjacent ends of the tube at the point of severance being opened. Due to the surface tension of the molten glass at the end of the tube above the suture, this end forms itself into a partially spherical form and hardens, sealing the tube against the ingress of microorganisms of any kind, so that the sutures will be preserved in a sterile condition until the tube is opened. The severed end of the glass tube with the cotton plug may then be thrown away, and the resul; is the finished product disclosed in Fig. l or These suture packages are preferably put up in cardboard cartons of the type illustrated in Fig. l. The carton comprises a lower cardboard box member 58 having four plane rectangular sides and having a plane rectangular bottom, the upper end being open. The cover 54 may be of identical shape, but is shorter; The glass tubes are preferably separated from each other by means of a plurality of tubular cardboard members 55, which are square in horizontal crosssection and in which the suture tubes 21 have a fairly tight frictional fit. The cardboard tubes 55 are of such size in relation to the box 58 and cover 54 that when they are assembled, as shown in Fig. 1, they fit in the box and cover, and they are retained in the box 53 by frictional engagement. The square cardboard tubes 55 are also shorter than the glass tubes, so that a sufficient amount of glass tube projects from the top of each cardboard tube 55 to permit grasp of the glass tube by the fingers to effect its withdrawal.
With this arrangement the assembly of cardboard tubes 55 forms a rectangular member which has a fairly tight frictional fit inside the inner walls of the cover 54 to retain the cover in place. An
extra label 56 indicating the type, quality and other characteristics of the gut is preferably included above the tubes inside the cover 54 and is in the form of a gummed label so that it may be applied to the container of alcohol, in which all of the tubes 21 are generally immersed when .they are removed from the carton at the hospital. A cotton pad 51 may be included in one or both ends of the container which comprises the cover 54 and box 58.
It will thus be observed that we have provided an improved package or packaged suture which is adapted to be shipped without danger of breakage and by means of which the suture is preserved in a sterile condition for a long period of time until the tube is broken open. The tubes are adapted to be broken squarely and cleanly, and the reel and suture are adapted to be removed with a minimum amount of difliculty so that the suture can be easily uncoiled. The loose end of the suture is immediately available when the tube has been broken off, and there is no need to search for it before threading the needle. The packaged suture is the product of a system which is closed bacteriologically from the time when sterilization is begun until the tube is 'finally sealed and the suture is permanently enclosed in glass. The package may be utilized for sutures of the boilable or non-boilable type, and the product is the result of such a system'that it is certain that the suture is absolutely sterile at the time it is used. This is a matter of life or death for the patient and success or failure for the surgeon.
While we have illustrated a preferred embodiment of our invention, many modifications may be made without departing from the spirit of the invention, and we do not wish to be limited to the precise details of construction setforth, but desire to avail ourselves of all changes within the scope of the appended claims.
Having thus described our invention, what we claim as new and desire to secure by Letters Patent of the United States is:
1. In a suture package, the combination of a lower box member having plane rectangular sides and end witha cover member of similar shape and a plurality of tubular members of the same material, said tubular members being open at each end, and a plurality of assembled tubular members being adapted to fit snugly within the box and cover, said tubular members projecting from said box to efiect engagementwith the inside of the cover, whereby the cover and box are retained in assembled relation by frictional engagement with the tubular members.
2. In a suture package, the combination of a lower box member having plane rectangular sides and end with a cover member of similar shape and a plurality of tubular members of the same material, said tubular members being open at each end, and a plurality of assembled tubular members being adapted to fit snugly within the box and cover, said tubular members of substantially the same size, and a plurality of rigid tubular paper members forming an assembly having a substantial fit in the lower box member and in the upper box member, with a. plurality of closed glass tubes, said glass tubes having a frictional fit in said tubular member: and engaging the sides of said tubular members to prevent the application of bending stress to said glass tubes in any direction, said glass tubes being slightly shorter than said tubular members, said glass tubes being formed intermediate their ends with a restricted portion and the restricted portion having the wall thereof ground away over the full periphery of said glass tubes to provide a tube which is breakable at said restriction by bending in any direction, a reel of indurated fiber in each of said glass tubes, said reel comprising a pair of pieces of fiber, each formed wlith a fiat body and with longitudinally extending fingers at each end, the parts of said reel being held in engagement with each other by the walls of said tube, a suture coiled upon said reel and having its coils expanded into engagement with the walls of said tube below said restriction to hold said suture in the lower part of said tube, said reel being of size to pass the inside of the tube at said restriction.
4. In a suture package, the combination of a lower box member with an upper box member of substantially the same size, and a plurality of rigid tubular paper members forming an'assembly having a substantial fit in the lower box member and in the upper box member, with a plurality of closed glass tubes, said glass tubes having a frictional fit in said tubular members and engaging the sides of said tubular members to prevent the application of bending stress to said glass tubes in any direction, said glass tubes being slightly shorter than said tubular members, said glass tubes being formed intermediate their ends with a restricted portion and the restricted portion having the wall thereof ground away over the full periphery of said glass tubes to provide a tube which is breakable at said restrictiOn by-bending in any direction, a reel of indurated fiber in each of said glass tubes, said reel comprising a pair of pieces of fiber, .each formed with a fiat body and with longitudinally extending fingers at each end, the parts of said reel being held in engagement with each other by the walls of said tube, a suture coiled upon said reel and having its coils expanded into engagement with the walls of said tube below said restriction to hold said suture in the lower part of said tube, said reel being of size to pass the inside of the tube at said restriction, and a sterile preservative liquid in said tubeand extending to a point above all of said suture.
WALTER. S. DAVIS. CHARLES T. DAVIS.