Suture Package

Abstract

A surgical suture package, primarily for double armed multi-strand sutures, retains each individual suture in a predetermined sinusoidal configuration within adjacent but separate compartments. Notches along one edge of the package secure the armed ends of each suture which are held in place within the package when the compartments are folded together. As the package is unfolded, the armed ends are exposed sequentially, facilitating removal by the surgeon of each suture from its compartment one at a time without tangling and kinking.

Description

The present invention relates to packages for surgical sutures in coiled form, and more particularly to sterile, double armed, braided silk sutures and the like packaged in this manner.

When the term suture or sutures is used in this application, it shall mean elongated strands suitable for suturing, ligating, or surgical procedures and shall include those strands commonly called sutures and ligatures.

When the term double armed sutures is used in this application, it shall mean a suture that has affixed to each end thereof a surgical needle.

When the term multi-strand package is used in this application, it shall mean a package containing a plurality of suture strands, i.e., four to six or more.

Heretofore, double armed sutures have been packaged in various ways intending to minimize the formation of kinks or sharp bends in the suture strand due to packaging. For instance, the suture has been wound upon circular reels and various other attempts have been made to coil the suture smoothly and in such a way that no kinks will be formed. Necessarily, when the suture has been coiled in this manner, it has been retained in the package in coiled form for an extended period of time prior to use. As a result, the suture strands adopt a set configuration based upon the form in which it was coiled, even when they are removed from the package. Thus, when a suture which has been coiled in circular form on a reel is removed from the reel, it will tend to return or snap back into a circular configuration. When the suture is attached to a needle, as it normally is for suturing purposes, the surgeon must prevent the suture strand from coiling up against the needle and interfering with the surgical procedure. This is a difficult problem because it is almost impossible to prevent sutures from assuming a set during packaging.

The problem referred to above is accentuated when the suture has a needle attached to both ends as the suture has a tendency to coil up against the needles at either end thereof making it difficult for the surgeon to handle. The present package permits the surgeon to grasp one needle in a needle holder and remove the suture from the package without entangling the suture with the needle that is attached to the other end.

Because a large number of double armed sutures are frequently used in a single surgical procedure, it is desirable to package a number of identical sutures, i.e., four to six or more in a single package. In such multi-strand packages, it is important to immobilize the needles attached to each suture so that they remain separated from and do not become entangled with other double armed sutures within the package.

In accordance with the present invention, a folded package for multi-strand double armed sutures is provided which will hold two to six or more sutures in a predetermined sinusoidal configuration within adjacent but separate compartments. Notches along one edge of the package secure the armed ends of each suture so that the attached needles are locked in position as the compartments are folded together. The package of the present invention permits the surgeon or his assistant to remove each suture one at a time and as needed without entanglement.

In accordance with the present invention, the suture is wound in the form of a coil similar to that described in U.S. Pat. No. 3,444,994. The suture coil has a multiplicity of figure-eight convolutions which are superimposed one upon the other in successive layers with the convolutions disposed in sequence from one end of the suture to the other. Each of the figure-eight convolutions comprise a centrally located suture crossing, and opposed loops on each side of the crossing with the loops also integral with the suture portions forming the crossings. As a result, the coils within each compartment are maintained in sequence and in layers in the suture crossings since these crossings prevent adjacent convolutions from telescoping or entangling with one another. When the suture is coiled in this manner and removed from the package by drawing up one of its ends, it assumes a non-entangling sinusoidal configuration of successive positive and negative lobes. When the suture is held by the needle at one end thereof, it remains extended in this form and has no tendency to coil up again adjacent the needle at either end.

In the preferred form of our invention and most particularly, when the suture is a stiff monofilament, the suturing needle that is attached to the ends of the suture is curved and each needle is retained in the package in such a way that when the suture is removed therefrom as described above, the point of the needle is directed away from the next adjacent suture lobe thereby assuring that the suture will trail behind the needle point during surgery. To accomplish this, both curved needles and the suture end attached thereto are retained in the package in such a way that the curve of the needle and the suture end attached thereto generally follows the curved configuration of the suture coil. The suture ends are arranged so that they generally continue to follow the shape of the figure-eight and the needles attached thereto are positioned in such a way that they appear to be a continuation of the coil configuration.

In the package of this invention, each individual suture is held in the desired coil form within adjacent compartments foldably connected with one another and adapted to be folded together and superimposed so that the figure-eight suture coils in each compartment are in registry and the armed ends of the suture and attached needles extend from adjacent ends of each compartment. Preferably, there is a notch in the open end of each compartment along one edge of the package to hold the armed ends of the suture in position until the compartments are folded together.

The double armed suture may be wound as it is being positioned within each compartment of the package by employing a jig which cooperates with or penetrates a portion of the package as described in U.S. application Ser. No. 225,814 filed Feb. 14, 1972. The package is adapted to be closed easily by folding and may be held together with a retaining sleeve or by interlocking tabs which secures the coil convolutions and needles in the desired relationship within the package. The package with the sutures in position therein is then hermetically-sealed in an outer container and sterilized with gamma radiation.

Other and further advantages of this invention will appear to one skilled in the art from the following description and claims taken together with the drawings wherein:

FIG. 1 is a plan view of a rectangular card that forms the suture package of the present invention.

FIG. 2 is a perspective view of the card of FIG. 1 with 4 double armed sutures in place.

FIG. 3 is a perspective view of the suture package with adjacent compartments folded together.

FIG. 4 is a perspective view of the suture package in its closed position.

FIG. 5 is a perspective view of the suture package of FIG. 4 enclosed in a hermetically-sealed envelope.

FIG. 6 is an enlarged perspective view of interlocking tabs located on opposed edges of the suture package, said package being in an open position.

FIG. 7 is an enlarged perspective view of the interlocking tabs of FIG. 6, the suture package being in a closed position.

FIG. 8 is an enlarged end view of the interlocking tabs illustrated in FIG. 7.

FIG. 9 is a perspective view of the suture package in a partially opened position illustrating the removal of a double armed suture from its compartment.

FIG. 10 is an enlarged fragmentary sectional view on the line 10--10 of FIG. 9.

Referring to the drawings, FIG. 1 shows a rectangular card 20, preferably 27 lb. per ream bleached Kraft paper. The lower edge 21 of the card is cut with keyhole notches 22 which serve to retain in alignment the armed ends of the suture. As best shown in FIG. 2, after the double armed sutures 23 are in place, the card 20 is folded along its center line 24 to provide overlying panels 25 and 26 which together form the side edges 29 and 30. The ends of the double armed sutures 23 are retained by the keyhole notches 22 with the needles 35 extending downwardly.

To complete the formation of the suture package, the overlying panels are folded inwardly along fold lines 27 and 28 parallel to the side edges 29 and 30 to form adjacent compartments 31 and 32, separated by the fold line 27 and adjacent compartments 33 and 34 separated by the fold line 28.

As best shown in FIG. 3, a flap 36 that extends above the panel 25 is folded down over the top of compartments 33 and 34 thereby effectively closing both compartments and retaining them in their adjacent position with the needles 35 immobilized. In a similar manner the flap 37 is folded in the direction of the arrow over the top of compartments 31 and 32 to close and retain those compartments in their folded position with the needles immobilized. The package is then closed by folding compartments 31 and 34 together along the fold line 39 to bring all compartments of the suture package into juxtaposition with the double armed sutures in registry.

If desired, a paper retaining sleeve (not shown) may be slipped over the suture package to prevent opening thereof. Alternatively, oblique cuts 41 and 42 may be placed in the card 20 to provide interlocking tabs 43 and 44 that serve to hold the package together in its closed position.

The folded double armed multi-strand suture package is then overwrapped by placing it within an outer envelope of coated foil 50 that is heat sealed to provide a hermetically sealed over-wrap envelope that is illustrated in FIG. 5. The over-wrap envelope has a tear line 52 at one end for opening the envelope when it is desired to obtain access to the suture. This package may be sterilized by gamma rays and is then ready for shipping and storage.

In use, the surgeon or his assistant may remove the outer wrapper by grasping it on either side of the notch 52 and tearing to eject the sterile primary package. The retaining sleeve if present is removed from the primary package or the interlocking tabs are pulled apart by the surgeon to open the package. The double armed sutures may then be removed sequentially one at a time without kinking or entanglement as best illustrated in FIG. 10.

It shall be noted that the curved needle 35 is disposed in such a way that it appears to continue the sinusoidal shape of the suture. The suture now tends to retain this sinusoidal shape and has no tendency to snap back into its original coiled form. As a result of this and the fact that the point of the needle is directed away from the next adjacent suture lobe, it is assured that the suture will trail behind the needle point during surgery and will not interfere with the surgical procedure in any way.

Claims

What is claimed is:

1. A multi-strand suture package comprising a card of relatively stiff material rectangular in shape having first and second flaps extending from one end thereof and folded along its center line to form overlying panels having a bottom edge along said fold, a top edge with said flaps extending therefrom, and two side edges; said panels being folded inwardly along fold lines parallel to said side edges to form first and second adjacent compartments and third and fourth adjacent compartments that are open at the top edge; each compartment containing a double-armed suture wound in the form of a coil comprising a multiplicity of figure-eight convolutions each of which comprise a centrally located suture crossing and opposed loops on each side of said crossing and integral with the suture portions forming the crossing, the suture crossing of successive figure-eight convolutions being superimposed one upon the other to dispose the convolutions in successive layers; a needle affixed to each end of each suture and extending from the open end of each compartment toward the bottom edge; said first flap being folded over the first and second compartments, and said second flap being folded over the third and fourth compartments, thereby closing the open end and retaining the needles in position between adjacent compartments; said first and second compartments being folded inwardly toward the third and fourth compartments to bring the first and second flaps together; and means for retaining the first and second flaps and adjacent compartments together in the folded position to form a suture package; whereby as the package is unfolded, said needles are exposed sequentially facilitating removal by the surgeon of each suture from its compartment one at a time without tangling or kinking.

2. A suture package according to claim 1 characterized by a "keyhole" notch positioned near the open end of each compartment that functions to retain said needles in a fixed position when adjacent compartments are folded together.

3. A sterile suture package according to claim 1 enclosed in a hermetically sealed envelope.

4. The suture package of claim 1 wherein the means for retaining the adjacent compartments together in the folded position are interlocking tabs.