Abstract:
A suture package ( 30 ) including a panel having a series of superimposed subpanels ( 32   a ). A suture ( 20 ) loops back and forth on the subpanels ( 32   a ) such that adjacent loops are retained on adjacent subpanels ( 32   a ) and the adjacent subpanels separate the adjacent loops from one another. In the preferred embodiment, an accordion style panel ( 32 ) is utilized and the series of subpanels ( 32   a ) are folded into a superimposed relationship. Various features are incorporated to reduce the instances or likelihood of kinking and tangling of the suture ( 20 ) when pulled from the package ( 30 ) by a user.

Description:
The present application is a continuation of PCT Ser. No. PCT/US01/02772 filed on Jan. 26, 2001, which claims the priority of provisional patent application Ser. No. 60/178,577, filed Jan. 26, 2000, now abandoned. The disclosures of each of these prior related applications are hereby fully incorporated by reference herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to packaging for sutures and, more specifically, to disposable packages used during medical procedures to allow ready deployment of the suture as needed by the surgeon or other medical personnel. 
     BACKGROUND OF THE INVENTION 
     Surgeons and other medical personnel use sutures on a daily basis. These sutures should be packaged in a manner allowing ready deployment, as necessary, as the need for suturing during surgery or other medical procedure arises. Various types of suture packaging have been proposed in the past and several types currently exist in commercial form. FIGS. 1 and 2 illustrate a suture  10  of the prior art comprised of a suture material  12  and suture needles  14 ,  16  at affixed opposite ends thereof. Generally, the most commercially successful types of suture packaging have involved uniformly looping the suture material in a figure eight configuration over itself within the package. Suture material  12  is generally formed from natural or synthetic materials that tend to become set into a kinked condition after being folded or looped and compressed for a period of time within the packaging. This characteristic, coupled with the current figure eight packaging techniques, cause the suture material to acquire a certain amount of stored energy much like a compressed spring. As the suture is taken from the package, it tends to come out all at once and, with the stored energy released in this uncontrolled manner, the suture material often becomes intertangled. 
     Suture  10  is schematically shown in FIG. 1 with the uniform loops  12   a  expanded for illustration purposes. Typically, these uniform loops  12   a  are compressed together and sandwiched between paper flaps within a flat, disposable package. Uniform loops  12   a  tend to become intertangled when removed from current packaging as discussed above, and as shown in FIG. 2, and further tend to create so-called “air knots”. Air knots are created when one of the suture needles  14 ,  16  passes through one or more loops  12   a  or when loops become intertangled either while they are pulled from the package or after they are pulled from the package. When pulled taught, a knot is formed making the suture  10  unuseable. Also, various folds in the suture packaging can cause sutures  10 , and especially fine or small diameter sutures, to hang up or become caught on fractured paper fibers caused by perforated edges. After the suture material  12  is removed from a conventional package, suture  10  does not hang straight as is most desirable, but tends to have significant bends or kinks created where the suture material  12  was looping back and forth within the packaging. Sometimes the suture is stretched or tensioned to remove the kinks before use, but this can result in breaking the suture. In emergency situations or other typical medical procedures, there is no time to allow the suture to relax and straighten. Therefore, the surgeon must use the less than desirable kinked suture. 
     To overcome various problems in this art, such as those mentioned above, as well as other problems in the art, it would be desirable to provide an improved suture package configured to reduce setting and subsequent kinking of the suture material, while also reducing the instances of loops becoming tangled or forming air knots when the suture is removed from the packaging. 
     SUMMARY OF THE INVENTION 
     The present invention therefore provides a suture package with several different features aimed at reducing various problems in this art. As one main feature, the invention provides a package which forms uneven loops, or loops of different length, to prevent the suture loops from becoming tangled and potentially forming air knots when removed from the package. To prevent kinking and to allow withdrawal of the suture in a controlled manner without tangling, the suture material is packaged in an accordion-style packaging material or other package configuration that physically separates adjacent loops of suture material. In the preferred accordion-style package, the suture material transitions over the folds between adjacent subpanels of an accordion-style panel at a gradual obtuse angle, such as an angle approaching a parallel orientation relative to the fold line. Inner folds of the accordion-style packaging are embossed to prevent pinching of the suture material, while outer fold lines are embossed or scored on the backside of the packaging to prevent the suture from hanging up on fractured paper fibers of the accordion-style panel. As used herein, the term “embossing” means applying discreet pressure along a fold line with or without scoring. An internal panel or member, preferably formed into a three-dimensional configuration or, in other words, at least having a three-dimensional thickness, prevents the package from being crushed and thereby pinching the suture material after packaging. 
     The loops formed along alternating subpanels of the accordion-style panel are initially formed on pins extending through the package from a packaging fixture as explained further below, but are retained by flaps after withdrawal of the pins at the end of the packaging operation. Loops formed on the opposite set of alternating subpanels are received by tabs at the bottom of the package. The tabs create a track for the suture material and slightly wedge the suture material in place. The tabs help prevent kinking and allow the suture material to be pulled from the package in a controlled manner by grasping and pulling the exposed suture needles from respective needle retention elements. Due to the accordion-style of the packaging, the suture material preferably does not fold or lay directly on top of itself. Rather, each loop of the suture material is separated by subpanels of the packaging. This further prevents the loops of suture material from hanging up on each other as they are pulled from the package. Although less desirable, it is also possible to place more than one loop between adjacent subpanels. Further, the transition between the suture material and the suture needle is straight and, therefore, no set or kink is created at this critical transition point. 
     The package of this invention may be a single suture package or a multi-suture package. For example, respective sutures may be retained on front and back sides of the accordion-style panel. The invention is also applicable to all types of suture material, but is especially advantageous with respect to those materials that easily take on a set. These materials tend to be monofilament sutures and sutures formed from natural gut. The invention is also especially suitable for packaging very fine suture materials, such as those used during cardiac surgery, hand surgery or other procedures using suture sizes of, for example, 6-0, 7-0 or higher. The foldable flaps in the suture packaging of this invention and the tabs create a certain amount of drag on the suture when the packaging is in its fully closed condition. This drag helps the suture to pull out in a controlled manner by causing the suture to retain its looped shape under each successive flap and tab as the suture material is being pulled out of the package. 
     In one general embodiment, the suture package has two long sides and two shorter ends. The suture needles are positioned for grasping preferably by exposing them at one of the ends and are removed with the suture material by pulling the suture from that end. Thus, the pulling occurs in a direction generally parallel to the length of the subpanels and the fold lines, if any, therebetween. In another embodiment, the suture needles are positioned for grasping preferably by exposing them along the length of one of the long sides of the suture package. Therefore, in this embodiment, the suture is pulled from the package in a direction generally transverse to the length of the subpanels and any fold lines therebetween. In this second embodiment, at least one advantage is provided by the fact that the suture material will not ride along the lengthwise edges of the subpanels during its removal. This can help prevent snagging and potential damage to the suture material caused by roughness along the lengthwise edges of the subpanels. 
     Generally, the method of packaging a suture in accordance with the invention includes looping a suture back-and-forth on a series of subpanels and superimposing the subpanels on each other such that adjacent loops of the suture are retained between adjacent, superimposed subpanels. Respective ends of the suture, which typically include needles attached thereto, are positioned for grasping in an accessible location. The superimposed subpanels are secured together in the form of a package either before or after the respective ends are positioned in the accessible location. 
     More specifically, the accordion-style panel is stretched out into a flat condition with the flaps containing the assembly pin holes flipped away from the accordion-style panel. The assembly pin holes of alternating subpanels on the accordion-type panel receive the assembly pins from the fixture. One of the suture needles is retained in a suitable needle retaining element at one end of the package and the suture material is looped back and forth over the assembly pins and then around the oppositely disposed tabs on each of the adjacent subpanels until reaching the final suture retaining element at the opposite end of the package. The assembly pins and the oppositely disposed tabs preferably force the suture material into curves of substantially constant radii to prevent sharp transitions in directions which may result in kinks. When this part of the packaging operation is complete, the flaps which were previously folded out of the way are folded back down over the pins. The pins are then withdrawn from the holes in the package by a suitable reciprocating feature of the packaging fixture and the accordion-style panel is folded together. The stiff internal panel is folded over first followed by the outside panel which is secured around the outside of the folded, accordion-style panel and retained in place. As one additional, alternative feature, the flaps which receive the pins may also be releasably connected to the underlying subpanels, for example, by forming perforations through the flap and underlying subpanel. This can be used to retain the suture loop in place beneath the flap until a user pulls the suture material and thereby breaks the connection between the flap and the underlying subpanel. At least one panel may have slots for receiving the assembly pins in an adjustable manner. This allows for adjustment in the length of, for example, the final loop of suture material to accommodate inconsistent lengths of different sutures during the packaging operation and allow the needle to reach and be retained in an accessible position with a straight transition between the needle and the suture material. 
     These and other objects, advantages, and features of the invention will become more readily apparent to those of ordinary skill in the art upon review of the following detailed description of the preferred embodiments, taken in conjunction with the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 schematically illustrates a conventional suture in slightly expanded form. 
     FIG. 2 illustrates the suture of FIG. 1 tending to become tangled in accordance with the prior art. 
     FIG. 3 illustrates a suture in accordance with the present invention having nonuniform loops of different lengths. 
     FIG. 4 is a schematic, perspective view of the accordion-style suture package constructed in accordance with the preferred embodiment of this invention. 
     FIG. 4A is a cross sectional view taken along line  4 A— 4 A of FIG.  4 . 
     FIG. 5 is a side elevational view of the accordion-style package. 
     FIG. 6 is a perspective view generally showing the gradual transition of the suture material over a fold line of a package constructed in accordance with the invention. 
     FIG. 7 is a schematic illustration of an embossed inner fold line between two panels of the suture package of this invention. 
     FIG. 8 is a schematic view of a scored, outer fold line between two panels of the package of this invention. 
     FIG. 9 is a cross sectional view of the accordion-style package showing the stiff inner panel providing support to the interior accordion-style panels. 
     FIG. 10 is a schematic illustration of the straight transition between the suture material and the suture needle. 
     FIG. 11 is a perspective view showing a panel with slots allowing length adjustment for inconsistent suture lengths. 
     FIG. 12 is a schematic illustration of the accordion-style package showing separation between the suture loops within the package. 
     FIG. 13 is a perspective view partially showing an alternative suture package. 
     FIG. 13A is a cross sectional view taken along line  13 A— 13 A of FIG.  13 . 
     FIG. 14 is a perspective view of another accordion-style suture package constructed in accordance with the invention. 
     FIG. 14A is a perspective view of the suture package shown in FIG. 14, but illustrating the package in a folded condition and removed from a holder. 
     FIG. 15 is a perspective view illustrating the suture package partially removed from the holder and removal of the suture therefrom. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 3 illustrates a suture  20  after packaging in accordance with the present invention. Suture  20  includes a suture material or thread  22  having suture needles  24 ,  26  at opposite ends and formed into a series of non-uniform loops  22   a ,  22   b . These loops do not tend to become tangled or form air knots when removed from packaging of the present invention. In addition, these loops do not form nearly the permanent or semi-permanent set formed by current and past suture packaging methods. 
     FIG. 4 illustrates an unfolded accordion-style package  30  constructed in accordance with the preferred embodiment. Package  30  includes an accordion-style paper panel  32  having a series of folded subpanels  32   a . Although paper is the currently preferred material for the various elements of package  30 , other materials may be used as well. Subpanels  32   a  are separated by outer folds  34  and inner folds  36 . Alternating panels  32   a  include integrated or otherwise connected flaps  38  which fold over from the top edge of panel  32  to apply slight compression to suture material  22  after the packaging operation is complete. Holes  40  are provided in these alternating subpanels  32   a  and a like series of three holes  42  are provided in the corresponding flaps  38 . When flaps  38  are folded over, holes  40  register in alignment with holes  42 . Holes  40  receive respective pins (not shown) extending from a suitable packaging fixture to allow suture material  22  to be directed in the manner shown in FIG.  4 . Respective tabs  44  angle slightly upward from tabs  39  affixed to the opposite alternating series of subpanels  32   a  and receive lower loops of the suture material  22 . This is more specifically shown in FIG.  4 A. Tabs  44  are at staggered distances from the respective series of holes  40  to create the uneven loop pattern discussed above and shown in FIG.  3 . An inner stiff panel  50  in package  30  has a three-dimensional configuration formed by a lip  52  for purposes to be discussed in greater detail below. An opening  54  is provided in flap  50  to expose needle  24  to allow removal of suture  20  by the user. An outer flap  60  is provided to enclose and secure the entire package in its folded condition (FIG.  9 ). 
     FIGS. 5,  7  and  8  illustrate the accordion-style panel  32  as well as outer fold lines  34  and inner fold lines  36 . As shown best in FIG. 7, inner fold lines  36  are embossed to prevent adjacent subpanels  32   a  from pinching suture material  22  in the folded condition. Also, outer fold lines  34  are scored on the back side as opposed to the front side thereof to prevent suture material  22  from hanging up or becoming caught on fractured paper fibers when directed over the fold line  34 , as shown in FIG.  6 . 
     FIG. 9 illustrates the package  30  in its fully folded and secured condition. In this illustration, it should be noted that stiff panel  50  and lip  52  prevent package  30  from being significantly crushed and thereby pinching the suture after packaging. This feature further inhibits kinking or causing suture  20  to hang up as it is withdrawn from package  30 . 
     FIG. 10 illustrates a portion of suture  20  illustrating the transition between suture material  22  and needle  24 . In accordance with the invention, this transition zone is substantially straight and, due to the packaging principles expressed herein, needle  24  is not permanently or semi-permanently set into a kinked or angled position with respect to suture material  22 . 
     FIG. 11 illustrates an alternative subpanel  32   a′  which may be used in the end subpanel, for example, adjacent flap  60  (FIG.  4 ). Subpanel  32   a′  includes elongated slots  40 ′ adapted to carry adjustable pins  70  during the packaging operation. For example, pins  70  may extend upwardly from a fixture (not shown) and may adjust in position along the length of slots  40 ′ to adjust and accommodate the length of a particular suture. 
     FIG. 12 schematically illustrates accordion-style panel  32  and suture material  22  directed in a generally serpentine fashion over adjacent subpanels  32   a . Subpanels  32   a  prevent adjacent loops of suture material  22  from contacting one another when accordion-style panel  32  is folded as shown in FIG.  12  and then compressed as shown in FIG.  9 . 
     As understood from reviewing FIG. 4, the packaging operation involves unfolding accordion-style panel  32  into a flat condition and placing holes  40  over separate series of extendable and retractable pins (not shown) associated with a suitable fixture. Once panel  32  is stretched out into this flat condition and retained on the fixture pins, suture  20  may be successively directed around the pins extending through holes  40  and also around tabs  44  as shown in the drawing. Once this is accomplished, flaps  38  are folded over such that the pins extend through holes  42 . The pins are then retracted and accordion-style panel  32  is immediately folded into its compressed condition shown in FIG.  9 . Flap  50  is folded over first and then flap  60  is secured around the outside thereof, such as by using a suitable adhesive. To withdraw suture  20 , the user preferably grasps both of the exposed needles  24 ,  26  and pulls suture  20  from package  30 . 
     FIGS. 13 and 13A illustrate an alternative accordion-style package  80  shown in partial form, with suture material  22  directed therethrough in a similar fashion to the previously described embodiment. Package  80  includes a plurality of accordion-style folded subpanels  82  connected by fold lines  84 ,  86 . Alternating subpanels  82  have flaps  88  folded over from upper ends thereof, while subpanels  82  therebetween include folded over flaps  90  affixed to the respective subpanel  82  to form a tab  92  in a manner and for reasons similar to the previously described embodiment. In this embodiment, flaps  88  are perforated into subpanels  82  as shown in FIG.  13 A and along a curved path following the path of suture material  22 . This forms a track to retain suture material  22  in the intended looping configuration above the perforations  100 . As suture material  22  is pulled downwardly from package  80 , as viewed in FIG. 13, the connections between subpanels  82  and flaps  88  formed by perforations  100  will break and allow suture material to be withdrawn from package  80  in the previously described controlled manner. 
     FIGS. 14,  14 A and  15  illustrate an alternative embodiment of a suture package  120 . In these figures, like reference numerals indicate like structure or elements with other embodiments of the invention. Suture  20  is again retained on an accordion-style panel  122  comprised of a plurality of subpanels  122   a . Suture material  22  includes suture needles  24 ,  26  at opposite ends and is formed into a series of loops placed on adjacent subpanels  122   a  as in previous embodiments. Other features of the previous embodiments may or may not also be included in this embodiment. Subpanels  122   a  are separated by folds  124 ,  126  and suture material  122  crosses these folds at an angle a which is obtuse and preferably approaches parallel relative to the fold lines  124  or  126 . For example, suture material  30  is ideally within about 30° of parallel (angle α≧150°) to fold lines  124  or  126  as it crosses from one subpanel to the next. The main difference between suture package  120  and the suture packages of the previous embodiments is that suture needles  24 ,  26  exit suture package  120  along a side edge of package  120 , as best shown in FIG. 14 a  and  15 , instead of exiting at one end. This allows suture  20  to be pulled out essentially in a perpendicular direction to the fold lines  124 ,  126  as shown in FIG.  15 . Therefore, suture material  22  is not dragged along fold lines  126 . 
     It has been found that outer fold lines  126  may have discontinuities which tend to snag on suture material  22  if suture material  22  is pulled out from one end of package  120  as opposed to being pulled out along the long side as shown in FIG.  15 . Thus, this embodiment prevents this snagging and any potential damage to the suture material  22  which results therefrom. As further shown in FIGS. 14 and 14A, a pair of paper flaps  130 ,  132  may be used to secure panel  122  in its folded condition, such as by adhesively securing flaps  130 ,  132  in the positions shown in FIG.  14 A. Package  120  may then be placed in a suitable holder, such as a flat hollow paper holder  140  for final packaging and shipping purposes. As an alternative, this separate outer package portion or holder  140  may be an integral member such as a flap. As further shown in FIG. 15, when suture package  120  is ready for use, package  120  is partially or fully removed from holder  140  and a suitable surgical implement  142  is used to pull suture  20  from package  120 . This embodiment retains the advantages of the previously described embodiments in terms of providing a non-kinking and non-tangling suture, and further prevents any potential suture damage or other difficulties as the suture  20  is quickly removed at the point of use. 
     While the present invention has been illustrated by a description of a preferred embodiment and while this embodiment has been described in some detail, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features of the invention may be used alone or in numerous combinations depending on the needs and preferences of the user. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known. However, the invention itself should only be defined by the appended claims, wherein