Package for surgical sutures

Abstract: A package (10) for surgical sutures and suture needle assemblies comprising three interconnected panels, a first panel (12) serving as a suture retaining panel, a second panel (14) connected to said first panel and serving as a front cover, and a third panel (18) connected to said second panel and serving as a back cover, wherein said first panel includes means (46) for retaining said sutures in an unfolded condition in said package.

Description: BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to packaging devices for surgical elements such as sutures and suture-needle assemblies, and more particularly to packages for monofilament-type sutures which are to be packaged in an unfolded and elongated condition. A package in accordace with the pre-characterising part of claim 1 is disclosed in US-A-4135623. 2. Discussion of the Prior Art Packages for surgical sutures and suture-needle assemblies having means for retaining the suture in the package are well known in the art. These packages typically provide a series of panels which are foldable about each other to enclose the suture within. In most cases, means are provided on the package for securing the needle in place, positioning the suture within the package where the suture is restrained from moving once the package is closed. In general, most suture packages in the prior art provide a retainer member consisting of a series of panels having perforated score lines which allow one panel to fold over another panel to close the retainer with the suture and needle packaged therein. Typically, the suture is wound in an oval or figure "8" pattern which reduces the size of the package and provides an efficient means for storing the sutures prior to use. Other packages provide a series of elongated loops which allows the suture to be stored in a relatively flattened condition with only a few bends in the suture material. In the surgical suture and suture-needle industry, a significant amount of emphasis has recently been placed on the condition of the suture when it is removed from the package. The "memory" retention of the suture has become an important feature in the practical use of sutures in an operating room, in that emphasis has been placed on the necessity of sutures having little or no bends or creases after they are removed from the package. In general, sutures that are wound in small packages in a figure "8" or oval pattern will exhibit numerous bends and creases along their length after they are removed from the package. This leads to an awkward suturing and stitching process in the operating room, in that the operating room personnel must first straighten the suture material to assist the surgeon in the process. Furthermore, the bends and creases may lead to entanglement of the sutures, particularly in packages in which numerous sutures are enclosed. Several types of sutures are prone to bending and creasing and as a result require packaging in individual paths or tracks within the suture package, which often leads to an expensive and elaborate package requiring additional assembly steps during manufacture. In particular, sutures constructed of plastic material such as polypropylene or sutures constructed of stainless steel easily develop creases during packaging which reduce the effectiveness of the suture in an operating room. Accordingly, it is important that these types of sutures be packaged with a minimal amount of bends or turns, in order to allow the suture to maintain its natural shape after removal from the package. While some packages in the prior art provide for the suture to be packaged in an elongated condition, these packages require at least one turn or bend in the suture to secure the suture within the package, particularly in cases where the suture is a "double-armed" suture, having needles at both ends of the suture. The bend in suture packaged in this manner is usually a sharp, 180° turn, which usually remains in the suture after the suture is removed from the package. The package for surgical sutures and suture-needle assemblies of the present invention provides an elongate package for accommodating suture material without folds and creases, the package having novel needle display means to make available an elongate suture which maintains its natural shape after the suture has been removed from the package. SUMMARY OF THE INVENTION According to one aspect of the present invention, there is provided a suture package as defined in claim 1, below. According to a second aspect of the present invention, there is provided a method of loading sutures into a suture package, as defined in claim 18, below. In accordance with a third aspect of the present invention, claim 24 below defines a method for packaging suture-needle assemblies. Claim 27, below defines a fourth aspect of the invention as a method of removing a suture-needle assembly from a package. The present invention provides an elongate package for surgical sutures and suture-needle assemblies which allows the suture to maintain its natural shape during packaging as well as after the suture is removed from the package for use in an operating room. The package is particularly suited for use with sutures that easily crease upon bending, such as sutures constructed of plastic material (for instance, polypropylene) or stainless steel. The package of the present invention which can be die-cut essentially comprises a sheet of packaging material such as paperboard, fiberboard, or any fibrous material such as Tyvek (a registered trademark of DuPont), which exhibits a series of interconnected panels. Preferably, the package of the present invention comprises three panels which are connected through scored or perforated lines which facilitate folding of the material about itself to form a package. A first of these three panels is provided with means for securing the suture and suture-needle assembly in an elongate and unfolded condition. The means for securing the sutures may be an elongate tubular member, preferably constructed of plastic or a rolled paperboard material, which provides a tubular housing for the sutures which essentially eliminates the possibility of creasing of the suture material. Such a tube is disclosed in DE-A-3735649. The tubular material can be secured to the first panel of the package in a series of overlapping die cuts in the material, which allows the material to grasp the tubular member to hold it in place. Alternately, an adhesive material or glue may be used to secure the tube to the first panel. The first panel may also be provided with a needle-retaining member, preferably a foam, adhesive-backed needle park which holds the needles in place within the package. The second panel, which forms the front panel of the package, may be provided with a bottom flap which folds over to form a bottom of the package. At the other end of the second panel is a needle display means adjacent the needles, which allows the needles to be covered within the package when the package is closed, and facilitates display and removal of the needles from the package without having to fully open the package to remove the sutures and needles. The third panel forms the back panel of the package and may be provided with a top extension flap which folds over the top of the package to completely enclose the needles. The third panel may also be provided with means for holding the package in a closed position, where the third panel cooperates with the first panel to maintain the package in a folded, closed condition. Locking means may be provided and generally comprises a tab and slot arrangement, but may also include adhesives such as heat activated adhesives to seal the third panel to the first panel to close the package. The tab may extend outwardly from the longitudinal edge of the third panel, but preferably is an inwardly die-cut tab, so that the longitudinal edge of the third panel is straight. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing features of the present invention will become more readily apparent and may be understood by referring to the following detailed description of an illustrative embodiment of the package for surgical sutures and suture-needle assemblies and its novel construction, taken in conjunction with the accompanying drawings, in which: Fig. 1 is a top view of a surgical suture and suture-needle assembly package of the present invention in the unfolded condition; Fig. 2 illustrates the surgical suture and suture-needle assembly package of Fig. 1 having suture-needle assemblies positioned in the package, still with the package in the unfolded condition; Fig. 3 is a top view of part of the surgical suture and suture-needle assembly package of Fig. 2 in the folded condition showing the needles exposed; Fig.4 is the top view of Fig. 3 but with the closure flap (26) in the folded condition; Fig.5 is a top view of an alternate embodiment of the package having suture-needle assemblies positioned in the package with the package in the fully unfolded condition; Fig. 6 is a top view of part of the package of Fig. 5 in the folded condition with the needles exposed; and Fig. 7 is a top view of another embodiment of the package of the present invention in the unfolded condition; and Fig. 8 is a top view of yet another embodiment of the package of the present invention in the unfolded condition. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now in specific detail to the drawings, in which like reference numerals identify similar or identical elements throughout the several views, Fig. 1 shows the package 10 of the present invention in the fully unfolded and unarmed condition. Package 10 essentially comprises a sheet of packaging material, preferably a fibrous material such as paper, paperboard, fiberboard, or Tyvek (a registered trademark of DuPont) which is a fibrous material constructed of spun bonded polyolefin fibers which are pressed together to form a sheet of fibrous material. Package 10 consists of a series of interconnected panels, and in the preferred embodiment comprises three panels which are foldable over each other through a series of scored or perforated fold lines. A first panel 12 serves as a needle and suture retaining panel, and is connected to the second or center panel 14 through a score line 16. When the package is fully folded, center panel 14 forms the front of the package. Panel 14 is connected to third panel 18 through score line 19, and third panel 18 forms the back of the package when the package is in the fully folded condition. Panel 12 is provided with a series of die cuts 20 which provide a means for retaining the surgical sutures to be packaged within package 10. Panel 12 is further provided with a cutout region 22 and a slit 23 at the top of the package whose function will be described later. Second panel 14 is provided with an end closure flap 38 which extends from the body of the package and is foldable about the second panel 14 through score line 40. Flap 38 provides a bottom closure to the package. Second panel 14 is provided with an upper edge 24 which defines a needle display area. A pair of fold over flaps 42 and 44 provide a cover for the needle display area, and open along score lines 16 and 19 at edge 24. Flaps 42 and 44 are best seen in Fig. 3 wherein flap 42 covers the tips of the needles to further protect the needles within the package. Third panel 18 is provided with a top closure flap 26 which is foldable about score line 28 to provide a cover for the needles when the package is fully folded. Locking tab 30 engages edge 24 of second panel 14 as best seen in Fig 4. Third panel 18 is provided with a series of tabs 32 for engaging slots 34 of first panel 12. The engagement of tabs 32 into slots 34 holds the package in the fully closed position. Tab 32 may be positioned to pass through slot 34 as well as slot 36 on second panel 14 to further secure the package. As an alternative to tabs 32 and slots 34 and 36, third panel 18 is provided with a strip of adhesive 60, as best seen in Fig. 7 , such as a heat or pressure sensitive adhesive material which will secure the third panel 18 to first panel 12 to hold the package in the fully closed position. In addition, slots 36 may be eliminated so that tabs 32 engage only slots 34 to hold the package in the closed position. Fig. 2 shows package 10 of Fig. 1 having a number of suture-needle assemblies in position within the package with the package in the fully opened condition. In order to maintain the original shape of sutures 48, the sutures are packaged in a tubular member 46, which is preferably a plastic tube or a tube of rolled paper material which resists bending and folding. Tubular member 46 is held in place by die cuts 20 which provide a means for overlapping tubular member 46 to hold it in place. While any number of die cuts 20 may be provided, the preferred embodiment provides two cuts as seen in Fig. 2. It is also contemplated that die cuts 20 be eliminated and tubular member 46 be secured to first panel 12 through adhesives. In order to secure needles 50, a foam, adhesive-backed needle park 52 is provided which is positioned along an edge of cutout 22. Cutout 22 facilitates grasping of the needles when the package is in the fully folded condition. Fig. 2 illustrates an alternate securement means for foam needle park 52 which secures needles 50 at cutout 22. In the embodiment shown in Fig. 2, needle park 52 overlaps cutout 22 so that as panel 12 is folded over panel 14, and panel 18 is folded over panel 12, the adhesive backed needle park 52 maybe secured directly to third panel 18 as best seen in Fig. 3. Fig. 3 shows the package in the closed position with the needles 50 secured in foam needle park 52. Needles 50 are displayed above edge 24 of second panel 14. As seen in Fig. 4, flap 26 is folded along score line 28 so that locking tab 30 engages edge 24 to close the package about the needles. Tab 30 is positioned at an angle to scored line 28 which aligns tab 30 with edge 24 in parallel relation when flap 26 is folded over the needles. Fig. 3 shows needles 50 secured in foam park 52 which overlaps cutout 22 of panel 12. In this manner, the adhesive-backed needle park is secured to both first panel 12 and third panel 18 as shown. Closure flaps 42 and 44 fold over to protect the needle tips and sutures as shown. To close the package, flap 26 is folded along score line 28 so that tab 30 engages edge 24 of second panel 14 in the manner as illustrated in Fig. 4. Figs. 5 and 6 show package in which the foam needle park is eliminated and needles 50 and sutures 48 are placed to overlay cutout 22 and slit 23 of panel 12. Tubular member 46 is secured in die-cuts 20 as previously described, and package 10 is folded as described above and as seen in Fig. 6 . To secure needles 50, flap 44 is folded over sutures 48, and then flap 42 is folded over needles 50 as shown. The edge of flap 42 is inserted into slit 23 to hold needles 50 in place. Flap 26 is folded over the assembly as described above. Alternate embodiments of the package of the present invention are of course possible. To engage tabs 32 slots 34 may be sufficient, with slots 36 being omitted. Package 80 of Fig. is identical to package 10 except that the tab and slot arrangement is eliminated and adhesive strip 60 is provided to secure the third panel 18 to first panel 12. In Figure 8, package 90 is similar to package 10 except for the provision of inwardly directed tabs 92 which are die-cut into panel 18. Panel 18 accordingly has a straight longitudinal edge 93, which overlaps first panel 12, and if desired, may overlay scored line 16 between panels 12 and 14. Tabs 92 engage openings 94 in panel 12 to hold the package 90 in a folded and closed position.

Claims: An elongate package (10) for surgical sutures and suture needle assemblies comprising three interconnected panels, namely, a first panel (12) serving as a suture retaining panel, a second panel (14) connected to said first panel and serving as a front cover, when the panels are folded, and a third panel (18) connected to said second panel and serving as a back cover, with fold lines (16, 19) between the respective panels which extend the length of the package, wherein said first panel includes means (46) for retaining said sutures in an unfolded condition in said package, in order that the suture needles may be located at a first end of the package; the package being characterised in that: each of the first and third panels has a needle display flap (42, 44) which extends from the respective lengthwise fold line across the first end of the second panel. A package as claimed in claim 1, wherein said first panel is a needle retaining panel in that it is provided with means for retaining needles of suture needle assemblies. A package as claimed in claims 1 or 2, wherein said second panel includes an extension panel (38) at a second end of said package which folds over to provide a package bottom. A package as claimed in claim 1, 2 or 3, wherein said third panel includes a fold over extension panel (26) at said first end of said package to provide a package top. A package as claimed in any one of the preceding claims, wherein said third panel further includes holding means (32) for holding said package in a fully folded and closed position. A package as claimed in claim 5, wherein the holding means co-operates with said first panel. A package as claimed in claim 6, wherein said holding means comprises at least one tab (32) which interlocks with at least one corresponding slot (34) on said first panel. A package as claimed in claim 7, wherein said at least one tab (32) extends outwardly from a longitudinal edge of said third panel. A package as claimed in claims 7 or 8, wherein said at least one tab (32) comprises an inwardly directed die-cut forming an edge which engages said at least one slot (34) on said first panel. A package as claimed in claims 5 or 6, wherein said holding means comprises an adhesive strip (60) which secures said third panel to said first panel to hold said package in the closed position. A package according to any one of the preceding claims, wherein said means for retaining said sutures comprises an elongate tubular member (46), whereby said sutures can be disposed in said tubular member in an unfolded condition. A package according to claim 11, wherein said first panel includes means (20) for retaining said tubular member (46). A package as claimed in claim 12, wherein said retaining means comprises a die-cut (20). A package as claimed in claim 13, wherein said die-cut (20) is foldable to grasp said tubular member. A package as claimed in claim 12, wherein said means for retaining said suture retaining means (46) comprises adhesives. A package as claimed in claim 2 or any one of claims 3 to 15 as dependent on claim 2, wherein said needle retaining means comprises an adhesive-backed foam needle park (52), said park being positioned so as to overlap an edge of said first panel to adhere to said third panel when said package is in the closed position. A package as claimed in any one of the preceding claims, wherein said needle display flap (42) on said first panel engages a slit (23) in said first panel (12) to hold said needles of said suture needle assemblies. A method of loading sutures into an elongate surgical suture package (10), said package having three interconnected panels (12, 14, 18) joined by longitudinal scored lines, (16, 19) with a pair of needle display flaps (42, 44) attached to each their panel and extending towards each other laterally at one end of the package from one end of the scored lines in an unfolded condition of the package, said method comprising: placing at least one needled suture in an elongate tubular member (46) with the needle at a first end of the package; securing said tubular member to a first panel (12) of said package; folding said first panel having said tubular member containing said at least one suture over a second panel (14) of said package; folding a third panel (18) over said first panel; and securing said third panel to said first panel to maintain said package in a fully folded and closed condition. A method according to claim 18, comprising the step of folding said needle display flaps (42, 44) over said first panel after said first panel is folded over said second panel. A method according to claim 18 or 19, wherein said third panel includes a fold over extension panel (26), said method further including the step of folding said fold over extension panel over said second and first panel and securing said flap to said second panel after said third panel is folded over said first panel and secured thereto. A method according to claim 18, 19 or 20, wherein said step of securing said tubular member to said first panel comprises positioning said tubular member within a plurality of overlapping die-cut flaps (20) to secure said tubular member. A method according to any one of claims 18 to 21, wherein a plurality of sutures (48) are positioned in said tubular member (46), said sutures having needles (50) attached to one end, said method further comprising the step of securing said needles to said package after said tubular member is secured to said first panel. A method according to any one of claims 18 to 22, wherein said method further comprising folding one (42) of said pair of needle display flaps over said needles and securing said flap member in a slit (23) in said first panel (12) to secure said needles to said package. A method for packaging surgical suture-needle assemblies in an elongate package including three interconnected panels, namely, a first panel (12) serving as a suture and needle retaining panel, a second panel (14) connected to said first panel and serving as a front cover, and a third panel (18) connected to said second panel and serving as a back cover, with fold lines (16, 19) between the respective panels which lines extend the length of the package, said first panel including a tubular member (46) for holding said suture and needle assemblies in an unfolded condition, said package including needle display means (42, 44) at a first end of said package, the second panel including a fold over extension panel (38) at a second end of said package, the needle display means comprising a pair of needle display flaps (42, 44) attached to the first and third panel respectively and extending towards each other laterally from one of said fold lines, said third panel including a fold over extension panel (26) at said first end of said package, and said third panel further including holding means (32) which co-operates with at least said first panel for holding said package in a fully folded and closed position, said method comprising: placing at least one suture-needle assembly in said tubular member; securing said tubular member to said first panel; securing said needles to said first panel; folding said first panel over said second panel; folding said second panel fold over extension panel (38) over said first panel; folding said third panel over said first panel; securing said third panel to at least said first panel to maintain said package in a closed condition; folding said third panel fold over extension panel (26) over said first and second panel and securing said extension panel to said second panel to fully close said package. A method according to claim 24, further comprising the step of folding said flap members (42, 44) over said needles and engaging one (42) of said flap members in a slit (23) in said first panel to secure said needles to said first panel. A method according to any one of claims 18 to 25, wherein said steps of securing said needles to said first panel comprises first positioning said needles in a foam needle park and then securing the needle park to said first panel. A method of removing a surgical suture-needle assembly from an elongate package (10), said package including three interconnected panels, namely, a first panel (12) having said suture needle assembly (48) secured thereto in an elongate tubular member (46), said needle assembly being secured in a foam needle park (52) on said first panel, said first panel being folded over a second panel (14), said package having a pair of flap members (42, 44) forming needle display means at a first end and an extension panel (38) folded over said first panel at a second end, and a third panel (18) folded over said first panel and secured thereto to maintain said package in a fully closed position, said third panel including a fold over extension panel (26) at said first end which is folded over said first and second panels and secured to said second panel said pair of flap members being attached to said first (12) and third (18) panels, respectively; said method comprising: opening said package by unfolding said third panel extension panel (26) to reveal said needle display means (42, 44); unfolding said flap members (42, 44) of said needle display means to reveal said needle; grasping said needle (48); and removing said suture-needle assembly from said package by sliding said assembly out of said elongate tubular member (46); wherein said suture is maintained in an unfolded condition by said tubular member.

Inventors: HOLZWARTH HENRY A, SCANLON CHRISTOPHER M, HOLZWARTH, HENRY A., SCANLON, CHRISTOPHER M.
Applicants: UNITED STATES SURGICAL CORP, UNITED STATES SURGICAL CORPORATION
Application year: 1992
Main classification: A61B17
IPC codes: A61B17, A61B19