Abstract:
Featured is a device for holding spools, tube-shaped devices with various cross-section configurations, and cylindrical devices with recessed ends such as surgical suture spools and a means of manufacturing the device, wherein the device provides greater stability to the spool, tube-shaped device or cylindrical device with recessed ends and the means of manufacture does not require any major modifications to the current packaging process for the spool, tube-shaped device and cylindrical device alone. Moreover, when the device is a holder and dispenser for armed surgical sutures, the surgical suture needle is visible and readily accessible.

Description:
FIELD OF INVENTION 
     The present invention relates to a holder and dispenser for spools, tube-shaped devices, and cylindrical devices with recessed ends that firmly and securely holds and stabilizes the spool, tube-shaped device with various cross-section configurations, or cylindrical devices with recessed ends attached thereto and a process of manufacturing the holder and dispenser; but more particularly, this invention is directed to holders and dispensers for spools, tube-shaped surgical devices, and cylindrical devices with recessed ends, especially holders and dispensers for surgical sutures with a needle attached thereto, which needles are visible and readily accessible. 
     BACKGROUND OF THE INVENTION 
     The prior art includes numerous methods of packaging sutures for use in a surgical procedure. A few examples of suture packaging devices includes Brown et al. (U.S. Pat. No. 5,359,831), which discloses a molded suture container for retaining and dispensing absorbable and non-absorbable surgical sutures; Brown et al. (U.S. Pat. No. 5,566,821), which discloses a folded paper or plastic surgical suture retaining package device that delivers surgical sutures, which are wound in an hourglass configuration, in a controlled and tangle-free manner; Cerwin et al. (U.S. Pat. No. 5,788,062), which discloses a suture coil in an inexpensive paper or plastic dispenser with a rigid winding fixture; and Gemma et al. (U.S. Pat. No. 6,016,905), which discloses sutures wound in a figure eight configuration in a plastic snap-lock suture container. Recent innovations in suture dispensers include cylindrical spools, containing fixed length, pre-knotted surgical sutures, which allow faster, easier and more secure endoscopic suturing. As an example, these dispensers may be used in various laparoscopic procedures such as a cholecystectomy or splenectomy, in which having a pre-tied knot is desirable. 
     Presently, armed suture spools, which is to say spools of sutures with a surgical suture needle attached thereto, come packaged in a sterilized blister, pouch or bag. When sutures are needed in a surgical procedure, an armed suture spool is placed into a sterile area from which it can be grabbed and used as needed. However, the spool itself is unstable and can roll freely. Moreover, grabbing the needle may be awkward as the needle must first be located and then picked up from the surgical area. Therefore, a need exists for a cylindrical spool holder that is stable, that facilitates grabbing a suture needle, and that quickly and easily dispenses sutures. 
     SUMMARY OF THE INVENTION 
     The present invention features an innovative device for holding and dispensing spools, tube-shaped devices with various cross-section configurations, and cylindrical devices with recessed ends, and, more particularly, spools containing armed surgical sutures and, furthermore, a method of manufacturing the device. The holder and dispenser disclosed in the instant invention confines a spool, tube-shaped device, or cylindrical device with recessed ends between a pair of tabs, stabilizing the spool, tube-shaped device, or cylindrical device with recessed ends and, further, preventing it from rolling freely. Furthermore, the holder and dispenser disclosed herein retains a surgical suture needle in a location where it can be readily seen and easily grabbed. The instant invention, moreover, allows the spools, tube-shaped devices and cylindrical devices with recessed ends to be sterilized and packaged without requiring major modifications in the packaging materials or processes that are presently used in packaging the spools, tube-shaped devices and cylindrical devices with recessed ends alone. 
     Therefore, it is an object of the present invention to provide a device for holding spools, tube-shaped devices, and cylindrical devices with recessed ends that stabilize the spool, tube-shaped device or cylindrical device with recessed ends contained thereon, preventing it from rolling. 
     It is another object of the present invention to provide a device for holding armed surgical sutures spools, tube-shaped devices or cylindrical devices with recessed ends that holds a surgical suture needle so it is visible and can be accessed easily. 
     It is a further object of the present invention to provide a simple means of manufacturing the holding and dispensing device for spools, tube-shaped devices or cylindrical devices. 
     It is yet another object of the present invention to provide a means of packaging the new device without requiring major modifications in the packaging materials or processes that are presently used for packaging the spools, tube-shaped devices and cylindrical devices with recessed ends alone. 
     The present invention attains the foregoing and additional objects by retaining a spool, tube-shaped device or cylindrical device with recessed ends in a folded blank device, which secures the spool, tube-shaped device or cylindrical device with recessed ends between a pair of tabs, minimizing translation in a lateral or longitudinal direction; and, furthermore, which safely secures the tip of a surgical suture needle where it is visible and can be accessed easily. Moreover, the present invention allows one to package the new device without requiring major changes to the packaging process that was performed on the spools, tube-shaped devices or cylindrical devices by themselves. 
    
    
     Other aspects and embodiments of the invention are discussed below. Moreover, additional objects and advantages of the present invention are apparent from the drawings and specifications that follow. 
     BRIEF DESCRIPTION OF THE DRAWING 
     For a fuller understanding of the nature and desired objects of the present invention, reference is made to the following detailed description taken in conjunction with the accompanying drawing figures wherein like reference character denote corresponding parts throughout the several views and wherein: 
     FIG. 1 is a plain view of an embodiment of the holding device blank; 
     FIG. 2 is a perspective view of an embodiment of the assembled device retaining a tube-shaped surgical device; and 
     FIG. 3 is a perspective view of an embodiment of a packaging container 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown in FIG. 1 a plan view of the holding device blank  10 , which has a certain shape around a perimeter  60 . The device blank  10  typically is die cut and made of paper, rigid plastic film, corrugated board, cardboard or any other pliable material that can be folded to form a compact holder without adhesives, tapes or staples. In the preferred embodiment, the device blank  10  is fabricated from 9-point paper. The perimeter  60  and dimensions thereof may vary to hold spools, tube-shaped devices or cylindrical devices with recessed ends of virtually any length or diameter. 
     The device blank  10  comprises a plurality of primary scoring or perforation lines  11  that segregate the device blank  10  into a base panel  12 , a pair of symmetrical side flaps  14 , a solid end flap  16 , and a windowed end flap  18 , which are manipulated in a manner describe in greater detail below to create a holding and dispensing device  100  for a spool, tube-shaped device or cylindrical device with recessed ends  40 . A pair of slits  13  is made on the pair of symmetrical side flaps  14  as a securing means, which also is described in greater detail below. A small slit for a needle  15  is made through the windowed end flap  18 , or, in the alternate, a small foam pad  65  is adhesively attached to the reverse side of the windowed end flap  18  for holding a surgical suture needle  66  safely and securely. 
     The base panel  12  has a plurality of slits  17 ,  19  and , which create, respectively, a tab  20  and a windowed tab  22  at a proximal  6  land a distal end  62  of the base panel  12 . The slit  17 , which produces the tab  20 , is symmetrical about the centerline  63  of the base panel  12 . The slit  17  can be configured to produce a tab  20  of any shape or dimension. In the preferred embodiment, the tab  20  has a rounded, circular end  25 . The slit  19 , which produces an opening  23  generally between the windowed end flap  18  and the windowed tab  22 , is symmetrical about the centerline  63  of the base panel  12 . The opening  23  can be any shape or dimension. In the preferred embodiment, the opening  23  is crescent-shaped. The windowed tab  22  also can be any shape or dimension. In the preferred embodiment the windowed tab  22  has a rounded, circular end  27  with a pair of wings  29 , intended to ease the material stripping for making a hole. 
     Secondary scoring or perforation lines  24 ,  26  on the tab  20  and on the windowed tab  22  facilitate folding the tab  20  and the windowed tab  22  for insertion into apertures at a distal  67 and proximal end  68  of a spool, tube-shaped device or cylindrical device with recessed ends  40 . Tertiary scoring or perforation lines  28 ,  29  on the tab  20  and on the windowed tab  22  provide flexibility to use the same holder on spools, tube-shaped devices or cylindrical devices with recessed ends that have smaller diameters or end openings. When squeezed between the thumb and index finger, the tertiary scoring or perforation lines  28 ,  29  bend sufficiently to facilitate inserting the tab  20  and the windowed tab  22  into apertures with a smaller diameter or end opening at a distal  67  and proximal end  68  of a spool, tube-shaped device or cylindrical device with recessed ends  40 . 
     Manufacture of the holding and dispensing device  100  is simple, requiring minimal automation. The device blank  10  is placed on any flat surface. The tab  20  and the windowed tab  22  are folded upwards, rotating generally about scoring line  24 . The tip of tab  25  and the tip of windowed tab  27  are then folded, generally downward and towards each other, rotating about scoring or perforation line  26 . The tip of the tab  25  and the tip of the windowed tab  27  are then inserted into apertures at the distal  67  and proximal end  68  of a spool, tube-shaped device or cylindrical device with recessed ends  40 . 
     If the spool, tube-shaped device or cylindrical device with recessed ends  40  contains surgical sutures with a surgical needle  66  attached thereto, the device blank  10 , with a spool, tube-shaped device or cylindrical device with recessed ends  40  attached loosely thereto, is placed on a fixture equipped with a pair of posts. The posts are guided through a pair of holes in the bottom panel  12 , which are created when the tab  20  and windowed tab  22  are folded up and inserted in the spool, tube. shaped device or cylindrical device with recessed ends  40 . The free-running end of the sutures is then wound loosely around the posts until the suture needle  66  is near the windowed end flap  18 . The device blank  10  is then removed carefully from the fixture and the sutures rest loosely on the bottom panel  12 . 
     The windowed end flap  18  is then folded about scoring or perforation line  11  approximately 180 degrees, or until the edge of the windowed end flap  30  contacts or nearly contacts the base of the windowed tab  22  at the secondary scoring or perforation line  24 , covering the end loops of the suture windings. In like manner, the solid end flap  16  is folded about scoring or perforation line  11  approximately 180 degrees, or until the edge of the solid end flap  32  contacts or nearly contacts the base of the tab  20  at the secondary scoring or perforation line  24 , covering the end loops of the suture windings. The tab  20  and the windowed tab  22 , which are bowed slightly due to the weight of the spool, tube-shaped device or cylindrical device with recessed ends  40 , respectively, prevent the solid end flap  16  and the windowed end flap  18  from unfolding upwards. Moreover, the solid end flap  16  and the windowed end flap  18 , respectively, lock the tab  20  and the windowed tab  22  in position, restricting movement longitudinally in the direction of the centerline  63 . A suture needle  66  is then inserted into the small slit  15 , so that the suture needle  66  traverses the crescent-shaped opening  23  in the windowed end flap  18 . In another embodiment, the suture needle  66  is inserted into a foam pad  65 , adhesively affixed to the windowed end flap  18 . This positioning of the suture needle  66  allows one to see the suture needle  66  clearly and to grab the suture needle  66 , eg., with forceps easily. 
     The pair of symmetrical side flaps  14  is then folded about scoring or perforation line  11  approximately 180 degrees, until the base of the tab  20  and the base of the windowed tab  22  are inserted in the pair of slits  13  on each of the symmetrical side flaps  14 , covering the suture windings. The base of the tab  20  and the base of the windowed tab  22  that are in communion with the slits  13  frictionally prevent the pair of side flaps  14  from unfolding upwards. The pair of side flaps  14  restricts lateral movement about the centerline  63  of the base portion  12 , and, in combination with the end flaps  16 ,  18 , further restricting longitudinal movement in the direction of the centerline  63  of the base portion  12 , providing greater stability to the holding and dispensing device  100 . The holding and dispensing device  100  can then be sterilized and inserted in a bag, pouch, or blister, hereinafter collectively referred to as packaging. 
     Packaging of the holding and dispensing device is an important part of the invention especially when the spool, tube-shaped device or cylindrical device with recessed ends is a tube-shaped surgical device containing armed surgical sutures. Indeed, the claimed invention precludes redesigning packaging materials that are currently used to package armed suture spools by themselves. Packaging protects the holding and dispensing device from chemical, mechanical, or microbiological degradation in shipping, storage or handling. Indeed, the qualities most desirable in packaging for such use are ease of opening and protection from degradation and/or contamination. 
     Absorbable sutures, which can be degraded by a process called hydrolysis, must be hermetically sealed in moisture impervious material, e.g., metal or aluminum foil pouch, which is heat sealed. Typically, the metal or aluminum foil pouch is further placed and sealed in a pouch made of medical grade paper and polyester/polypropylene sheeting to provide a second layer of protection. Non-absorbable sutures, which are not subject to degradation from hydrolysis, typically do not require hermetic sealing in moisture impervious material. Instead, it is perfectly acceptable to store non-absorbable sutures in a mylar/tyvek pouch, which is heatsealed. 
     The preferred embodiment of packaging for a holding and dispensing device  100  for absorbable sutures is shown in FIG.  3 . Absorbable sutures are protected by a dual packaging system  110 . The innermost package comprises a peelable moisture impervious barrier  120 , which has an upper side  121  and a lower side  122 . The moisture impervious barrier  120  typically is made of metal, e.g., aluminum, foil. The upper side  121  and the lower side  122  of moisture impervious barrier  120  are hermetically sealed  130 , eg., by heat or adhesive, to protect absorbable sutures from hydrolysis. Non-absorbable sutures do not require a moisture impervious barrier  120 . 
     The end of the upper side  123  and the end of the lower side  124  of the peelable moisture barrier  120  are not sealed. Instead, the end of the upper side  123  and the end of the lower side  124  of the peelable moisture barrier  120  have a tactile feel, es, ripples, to facilitate grabbing and separating the two ends  123 ,  124 . Indeed, the two ends  123 ,  124  can be grabbed with the thumb and index finder of each hand and opened easily with a small force produced when the thumb and index finger of each hand move in opposite directions to one another, breaking the hermetic seal  130  progressively. 
     A peelable outermost package  127  typically is made of a combination of medical grade paper and polyester/propylene sheeting. The upper side  125  and the lower side  126 , of the peelable outermost package  127  are hermetically sealed, e.g., by heat or adhesive, to provide an additional layer of protection to the contents therein. The end of the upper side  132  and the end of the lower side  133  of the peelable outermost package  127  are not sealed. Furthermore, the edges of the end of the upper side  132  and the end of the lower side  133  are serrated to facilitate separating the two ends  132 ,  133  with one&#39;s thumbs. To further facilitate separating the end of the upper side  132  and the end of the lower side  133  from each other, at least one comer  129  of the end of the lower side  126  is removed to expose at least one comer of the end of the upper side  128 . The end of the upper side  132  and the end of the lower side  133  of the outermost package  127  can be grabbed with the thumb and index finder of each hand and opened easily with a small force produced when the thumb and index finger of each hand move in opposite directions to one another. The preferred embodiment of packaging for non-absorbable, which do not require a moisture impervious barrier, comprises a peelable outermost package  127  described above. 
     When the holding and dispensing device  100  contains armed, absorbable, surgical sutures, one embodiment of the method of using this invention comprises, first, removing the packaging  110  to expose the holding and dispensing device  100  by peeling back, first, the ends of the upper side  132  and lower side  133  of the outermost package  125 , and, subsequently, peeling back the ends of the upper side  123  and the lower side  124  of the moisture impervious barrier  121 . Once the holding and dispensing device  100  has been exposed, it can be placed or dropped on a sterile field. When armed surgical sutures contained on the holding and dispensing device  100  are needed during a medical operation, a pair of forceps, or similar medical instrument, secures the surgical needle  66 . The spool  40  is forcibly removed from the restraining tab  20  and windowed tab  22  by manually pulling the spool  40  away from the holding and dispensing device  100 . The suture windings, which are contained beneath the end flaps  16 ,  18  and pair of side flaps  14 , are then forcibly extended and removed from the holding and dispensing device  100 . 
     Although a preferred embodiment of the invention has been described using specific terms, such description is for illustrative purposes only, and it is to be understood that changes and variations may be made without departing from the spirit or scope of the following claims.