US 3202273 A
Description (OCR text may contain errors)
1965 c. T. RIALL 3,202,273
SUTURE PACKAGE FOR SERVING SUTURES STERILE TWICE Filed Dec. 14, 1962 INVENTOR. CHARLES T. R/ALL United States Patent 3,202,273 SUTURE PACKAGE FOR SERVING SUTURES STERILE TWICE Charles T. Riall, Danhury, Conn, assignor to American Cyanamid Company, New York, N.Y., a corporation of Maine Filed Dec. 14, 1962, Ser. No. 245,365 3 Claims. (Cl. 206-633) This application is a continuation-in-part of Serial No. 773,600, filed November 13, 1958, now abandoned.
This invention relates to a non-breakable light-Weight, plastic package for surgical sutures in which the suture is packaged inside of three envelopes so that the suture may be twice available in sterile condition by stripping envelopes Without the requirement of a sterilizing operation, and hence served twice.
Plastic envelopes for surgical sutures are disclosed in several prior art patents, including Benjamin F. Hirsch, United States Patent 1,962,900, Suture Package, June 12, 1934, and H. J. Rynkiewicz and G. B. Ayres, United States Patent 3,043,067, Suture Package, July 10, 1962. Most of the absorbable sutures sold in the United States today are packaged in strippable envelopes. Some envelopes can be externally sterilized by immersion in a sterilizing liquid, but such liquid spreads any contaminants, and if contaminated shortly before use, so that the contaminant is not inactivated, can cause complications.
In an operating room it is desirable that the sutures be made available and stored on the sterile stand in a container which is sterile both inside and out.
Not all of the sutures which are stored on the sterile stand are used in a single operation because the surgeon must have spare sutures available on very short notice should they be needed. Such sutures as are not use in one operation are retained for later use in subsequent operations. The exterior surfaces of these unused suture packages must be regarded as of questionable sterility and provisions must be made for resterilization. In modern operating techniques sterility must be beyond question and if there is any question of compromise, the questioned item must be resterilized. The problem of resterilization has thus required the time and elfort of skilled personnel for resterilization. Additionally, certain types of plastic packages cannot be successfully resterilized because the plastic is attacked by sterilizing media.
the middle envelope is sterilely removed and placed on the sterile stand. The suture can then be removed for use by cutting through the two remaining envelopes with scissors and lifting out the suture, which is done by the sterile nurse just before the use of the suture. Such sutures as are not used are replaced in stock.
At the time of a subsequent operating room schedule, the second envelope is opened and the third or inner envelope removed, using sterile techniques and the inner envelope only is opened when the suture is used. By using the single envelope sutures first, normally all single envelopes are used before the double envelopes on the same suture stand are used, thus efficiently avoiding any problems of resterilization. Thus a 100% reserve can be carried at all times, Without resterilization.
Whereas all of the enevelopes may be of a type which are opened by cutting, it is more convenient to have at least the outer two envelopes of a strippable type which permits the separation of lips and stripping of th seal, thus discharging the interior contents of an envelope without any risk of contamination on the outer envelope being transferred to an inside envelope.
If any of the containers are of glass, of course, such container, if sealed, must be opened by breaking. Further, if scissors are used in opening, the blades of the scissors carry surface contaminants to the package edge, and any item removed through the cut edge is compromised. Hence, if the inner one or inner two envelopes are to be opened, by scissors, the exterior must be sterile at the time.
If a liquid containing envelope is cut, the flow of liquid spreads contamination. To avoid compromise of sterility, the outer envelope must be interiorly dry and opened by stripping.
The importance of being able to serve a single suture in a sterile envelope twice without an intervening sterilizing procedure has not been previously recognized.
Preferably, but not necessarily, all three envelopes are transparent or have at least one transparent face so that the suture itself and an identifying label packed with the suture in the interior envelope may be inspected. One or more of the envelopes may have one or more foil laminations, and external identification may be used.
The interior envelope or third envelope may contain the suture either dry or in a conditioning liquid. Sutures of silk, synthetic fiber, stainless steel, etc. are usually dry packed. Absorbable sutures such as catgut sutures made from the intestinal tissure of animals, are usually packed in a conditioning liquid such as ethyl alcohol, or a mixture of ethyl alcohol, isopropyl alcohol, and water, or other conventional conditioning liquid. Such conditioning liquid may contain a bactericidal agent and/ or a rust inhibitor to prevent rusting of needles which may be attached to the sutures.
in a preferred form at least, the second and third envelopes may be of a material which will stand sterilizing treatment should it become desirable to sterilize the external surfaces of such envelopes, because of gross miscount of the number of sutures to be made available for a surgical procedure. Packaging material consisting of a laminate of a polyester resin and a polyethylene resin, with the polyethylene resin on the inside and sealed to itself, gives many advantages. Such a laminate is economical, readily sealed, and is permeable to gaseous sterilizing agents such as ethylene oxide and is also impervious to liquid surface sterilizing agents commonly used by hospitals such as formaldehyde in alcohol. For best results, the envelope should be exteriorly dried after such sterilization, and because of the added time and cost at the hospital level, such procedure is to be avoided where expedient.
Certain of the novel features of the present invention are illustrated in the accompanying drawings:
FIGURE 1 is a partially broken away view of the triple envelope suture package with three strippable seals and a suture immersed in a conditioning liquid.
FIGURE 2 is a section along line 2-2 of FIGURE 1.
The innermost envelope or third envelope 11 is sealed in the form of a peaked strippable envelope in which is Q) sealed a suture 12 which is folded in a label 13 and immersed in a conditioning liquid 14.
The inner envelope is shown as being formed from two separate, flexible, transparent sheets. While other flexible transparent materials, such as cellophane, may be used, it is preferred that the inner film consist of a laminate having an external surface of a polyester film such as the polyester of ethylene glycol and terephthalic acid which is sold under the trademark Mylar, with an interior polyethylene or polyvinyl film. A laminate of a polyester and polyethylene film is available under the trademark ScotchPak. The polyester film may have a thickness of from 0.0005 to 0.005 inch and the polyethylene or polyvinyl film, a thickness of about 0.002 to 0.005 inch. The inner envelope may be formed by adhesively uniting the films. It is preferred, however, to heat seal the films using the polyethylene or polyvinyl films on the Such films may be heat sealed using a die of such shape as to form the desired size envelope.
Preferably the films are oversealed, that is, the variables of time, temperature and pressure are so adjusted that at least part of the polyethylene or polyvinyl film is dis placed from between the polyester films along the seal lines thus providing a seal which has less than maximum strength permitting the united laminates to be separated by tearing apart the seal. As shown in FIGURE 1, it is preferred that the seal have a roof shape seal 15 which is sometimes called a cathedral shape. At the peak of the roof is a stress concentrating tip to. The laminates from which the envelop-e is formed extend beyond the peak of the roof shape seal forming lips 17. In opening, the lips are pulled apart and the stress concentrating tip is the first point at which the films are held together and, accordingly, all of the tearing stresses concentrate at this tip, thus causing a tear to start. The tear once started is readily continued to strip apart the two films.
Preferably the roof shape seal and the two side seals 18 are formed at the same time, thus forming an openbottom envelope. The suture 12 is folded in the label 13 and inserted in the envelope. The suture containing envelope may then be sterilized. is of a polyester film alone, or other high melting plastic, the sterilization may be accomplished by heat. With the preferred polyester-polyethylene laminate the polyethylene is .too low melting for reliable heat sterilization and, accordingly, a sterilizing gas such as ethylene oxide or radiation such as X-rays, gamma rays, neutrons, or electrons is used to accomplish sterilization. The suture containing envelope is kept sterile while filling with the conditioning liquid which may be ethyl alcohol or a mixture of ethyl alcohol, isopropyl alcohol, and water or other conventional tubing liquid which may contain a bactericidal agent or a rust inhibiting agent, or both.
The bottom of the envelope is then sealed, forming the bottom seal 19.
The inner envelope may be formed from a single sheet of laminate bent double, in which case the side seams are convenient.y formed and the envelope closed with the roof shape seal. Similarly, the inner envelope may be formed with peripheral seals on all sides for cutting with scissors.
The inner envelope is then sealed in the second or middle envelope 20. This envelope is a strippable sealed envelope which may be formed of the same materials as is the inner envelope and here again, a laminate of polyester and polyethylene is preferred. Because of the ease of introducing the inner envelope, the second envelope may be formed on rolls simultaneously with the introduction of the inner envelope. Conveniently, the second envelope is formed under clean but not sterile conditions and is rendered sterile on the inside by either radiation or by placing the envelope in a sterilizing chamber containing sterilizing gas such as ethylene oxide, which permeates the envelope sterilizing the inside of the second if the inner envelope envelope and the outside of the third envelope. A cutting line 21 is imprinted on the face of the second envelope at such a point that cutting on the cutting line will cut through the second and third envelopes releasing the suture but without cutting the suture. A notch may be used in the edge of one or more envelopes to serve as a starting point for tearing the envelope.
The second envelope is then introduced in an outer envelope 22. The method of forming the outer envelope and the material of the outer envelope are the same as described for the second envelope. The interior of the outer envelope may be sterilized by a gaseous sterilizing agent such as ethylene oxide or by radiation.
The interior of both the outer envelope and the second envelope may be sterilized in a single operation by using more powerful radiation or a higher concentration of a sterilizing gas, or a longer exposure to the sterilizing gas. In many instances sterilizing after each sealing operation is preferred to give a greater reliability of sterilization under more convenient operating conditions.
In operating room usage the triple envelopes are normally introduced into the operating room and the outer envelope stripped, leaving the inner two envelopes in exteriorily sterile condition on the sterile stand so that the two envelopes can be cut at a single pass with scissors and the sterile suture removed.
Because it is necessary to have extra sutures available to take care of operating room contingencies at the conclusion of an operation certain packages remain which were once stripped but not used. For purposes of safety, it is necessary to regard such packages, even though probably sterile, as com-promised. In preparing for the next use of the operating room the second strippable envelope is stripped releasing the inner package in sterile condition. As such, single-wrapped packages should normally be used first in an operation, it is unlikely that any singlewrapped packages will remain after the second operation and in serial usage a reasonable reserve of sutures is constantly available without any additional effort on the part of operating room personnel, thus enabling marked savings in the labor costs of hospitals. As is becoming increasingly apparent, the savings in such labor costs furnish the most effective opportunity for reducing costs without reducing quality of medical care.
As will be obvious, the description of this invention is for preferred embodiments only and modifications which are within the scope of the appended claims suggest themselves to those skilled in the art.
1. A suture package comprising an outer, sealed, flexible, strippable envelope, dry and sterile on the inside, containing a second, sealed, flexible, strippable envelope, dry and sterile inside and out, containing an inner third, sealed, flexible envelope, sterile inside and out, each of said envelopes being readily cuttable with scissors, in which third envelope is a sterile suture; whereby the outer envelope can be stripped to release'a sterile double wrapped suture, both of which wrappings may be severed at a single pass by sterile scissors, at a line above the enclosed suture and at such a location that both the second and third envelopes are simultaneously cut without compromising the sterility of the suture, the operator, or the scissors, and the contained suture released for sterile use; and additionally whereby a second sterile stripping may occur where a compromise of sterility of the second envelope is encountered, and the sterile inner envelope released in sterile condition, which envlope may be opened at a single pass by sterile scissors, at a line above the enclosed suture without compromising the sterility of the suture, the operator, or the scissors, and the contained suture released for sterile use, said strippable outer and second envelopes being strippable by grasping one of a pair of projecting edges extending beyond the seal line of such envelope in each hand and separating the edges,
5 thereby separating at least in part the peripheral seal while retaining any contaminants in their original location on the surface of the envelope being stripped, and peeling the envelope back, whereby the contents are sterilely presented.
2. The suture package of claim 1, in which the inner third envelope contains an absorbable suture and a conditioning liquid.
3. The suture package of claim 1, in which the inner third envelope contains a sterile, dry suture.
6 References Cited by the Examiner UNITED STATES PATENTS 2,542,957 2/51 Adams 20663.3 5 2,824,642 2/58 Stoltz 206-633 2,902,146 9/59 Doherty 206-43 2,949,181 8/60 Buccino 20663.3
JOSEPH R. LECLAIR, Primary Examiner.
10 FRANKLIN T. GARRETT, Examiner.