Patent Publication Number: US-8122688-B2

Title: Suture winding device and methods of use thereof

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 12/698,205 filed Feb. 2, 2010, now U.S. Pat. No. 7,921,623, which is a continuation of U.S. patent application Ser. No. 12/002,254, filed on Dec. 14, 2007, now U.S. Pat. No. 7,665,279, which is a continuation of U.S. patent application Ser. No. 11/809,081 filed on May 31, 2007, now U.S. Pat. No. 7,694,489, which is a continuation-in-part of U.S. patent application Ser. No. 11/373,366 filed Mar. 10, 2006, now U.S. Pat. No. 7,322,161, which claims priority to U.S. Provisional Patent Application Ser. No. 60/661,184 filed Mar. 11, 2005, and the disclosures of each of the above-identified applications are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates to devices and methods for packaging sutures and, more particularly, to a suture winding device and methods for use thereof. 
     2. Background of Related Art 
     Packages for surgical sutures having needles attached at one or both ends are typically constructed according to the nature of the suture material and to how the sutures will be used. Generally, the package holds the suture and attached needles in place, protects them during handling and storage, and allows ready access to the suture for removal with minimum handling at the time the suture is to be used. 
     The packages are loaded with one or more needles that have a desired quantity of suture attached. After positioning the needle or needles in the package, the attached suture is generally looped within the package using tracks, rods, posts, or other suitable positioning structures located within the package. 
     An example of one such package is disclosed in U.S. Pat. No. 5,123,528 to Brown et al., currently owned and assigned to United States Surgical, that discloses a package having a number of tracks and a needle receiving park. Each track has a suture receiving port and an opposed vacuum port. By applying vacuum to the vacuum receiving ports, a quantity of suture is drawn through the suture receiving port and received in the track. After a predetermined quantity of suture is received by the track, a needle attached to the suture is positioned in the needle receiving park. 
     A device for winding a quantity of suture attached to a needle is disclosed in U.S. Pat. No. 5,473,854 to Demarest et al. that discloses an apparatus having a number of workstations for packaging needles with an attached suture. As a turntable of the apparatus rotates, a tool nest attached to the turntable is rotated from one workstation to the next workstation. Each workstation performs a specific task with respect to packaging the needle with attached suture. 
     SUMMARY 
     The present disclosure is directed to an apparatus for use with a suture package or retainer and one or more sutures. According to one embodiment, an apparatus for winding an armed suture includes a base member, a needle holder disposed in a region of the base member, and at least one needle having a quantity of a suture attached thereto. The apparatus further includes a retainer package disposed atop the base member, a plurality of rods engagable with and corresponding to the throughholes of the retainer package, and a holder having open and closed states. The plurality of rods are disposed in at least one array and the retainer package includes a first member having a plurality of throughholes. The holder is movable relative to the base member between a plurality of positions. The holder includes a first arm and a second arm. The first and second arms are in a spaced apart relation in the open state and at least a portion of the first arm are in substantial contact with at least a portion of the second arm in the closed state. 
     In one embodiment of the winding apparatus, the base member is rotatably mounted to a plate. The holder may slidably engages at least a portion of the suture in the closed state such that a predetermined amount of tension is applied thereto. The first member of the retainer may further include a slot for receiving a portion of the suture therethrough and is adapted to receive the needle in the needle holder. The rods of the at least one array may be movable from a retracted position to an extended position, the rods of the at least one array being releasably engagable with the suture in the extended position. Rotation of the base member may correspond to movement of the plurality of rods of the at least one array into the extended position such that at least a portion of the suture is wound about the plurality of rods thereby forming a plurality of loops. 
     In one embodiment, the at least one array may include a first array and at least one additional array. The rod of the first array and the at least one additional array may be independently and sequentially movable from the retracted position to the extended position. The first array and the at least one additional array may be arranged in a first arc and at least one additional arc. The first arc may define a smaller radius than the at least one additional arc such that each of the plurality of loops are in spaced apart relation, each of the plurality of loops defining a diameter that is larger than that of the previous loop. The holder may be manually movable through the plurality of positions. Alternatively, the holder is automatically movable through the plurality of positions. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Embodiments of the presently disclosed suture winding device are described herein with reference to the drawings, wherein: 
         FIG. 1  is a perspective view of one embodiment of the presently disclosed suture winding device with an embodiment of a holder; 
         FIG. 2  is a perspective view of the suture winding device of  FIG. 1  including a mounting member; 
         FIG. 3  is a side elevational view of the holder of  FIG. 1  in a first state; 
         FIG. 4  is a side elevational view of the holder of  FIG. 3  in a second state; 
         FIG. 5  is a perspective view of the suture winding device of  FIG. 1  with a pair of needles having a length of suture disposed in a needle holder and the holder being in a loading position; 
         FIG. 6  is a perspective view of the suture winding device of  FIG. 5  with a first member of a retainer positioned thereon; 
         FIG. 6A  is a perspective view of an alternate embodiment of the suture winding device of  FIG. 5 ; 
         FIG. 7  is a perspective view of the suture winding device of  FIG. 6  with the holder being in an unloading position; 
         FIG. 8  is a perspective view of the suture winding device of  FIG. 7  with a second member of the retainer positioned atop the first member of the retainer; 
         FIG. 9  is a perspective view of the suture winding device of  FIG. 8  and a heat staking apparatus; 
         FIG. 10  is a perspective view of the suture winding device and the heat staking apparatus of  FIG. 9  with a die plate positioned atop the retainer; 
         FIG. 11  is a perspective view of the suture winding device and the heat staking apparatus of  FIG. 10  after assembly of the retainer; 
         FIG. 12A  is a perspective view of another embodiment of the suture winding device and the heat staking apparatus of  FIG. 10  including a parking mechanism in a first position; 
         FIG. 12B  is a perspective view of the suture winding device of  FIG. 12A  in a subsequent position; 
         FIG. 13A  is a side perspective view of the parking mechanism of  FIGS. 12A-12B  showing the parking mechanism in an open condition; 
         FIG. 13B  is a side perspective view of the parking mechanism of  FIGS. 12A-12B  showing the parking mechanism in a closed condition; 
         FIG. 14A  is a perspective view of another embodiment of the presently disclosed suture winding device with an embodiment of the holder in the loading position and a first array of rods in a second position; 
         FIG. 14B  is a perspective view of the suture winding device of  FIG. 14A  showing a second array of rods in the second position; 
         FIG. 14C  is a perspective view of the suture winding device of  FIG. 14B  showing a third array of rods in the second position and the holder in the unloading position; 
         FIG. 15  is a perspective view of the presently disclosed suture winding device and another embodiment of a holder shown in a loading position; 
         FIG. 16  is a perspective view of the suture winding device and holder of  FIG. 15  shown in an unloading position; and 
         FIG. 17  is an exploded perspective view of an embodiment of the retainer. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     Embodiments of the presently disclosed suture winding device will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. 
     Referring initially to  FIG. 1 , the suture winding device, shown generally as  100 , includes a base  10  that is rotatably attached to a support plate  1  and is rotatable about a central point A. 
     As shown in  FIGS. 1 and 2 , base  10  includes a frame  18  and a plate  19  that is attached to a mounting surface  26  of frame  18 . In an embodiment of suture winding device  100 , frame  18 , and plate  19  have a generally oval or elongate elliptical configuration. Other shapes may also be used and are contemplated herein. Base  10  further includes a plurality of vacuum connections  12  where each vacuum connection includes a vacuum port  12   a . Each vacuum connection  12  is fluidly coupled to a vacuum source (not shown) such as would be known by a person of ordinary skill in the art. The actuation of vacuum connections  12  (i.e. applying negative pressure or suction to vacuum ports  12   a ) may be controlled manually or automatically. 
     In addition to vacuum connections  12 , a plurality of rods  22  is arranged on plate  19  and at least a portion of each rod  22  extends through top surface  24 . Each rod  22  includes a tip  23  that is configured and dimensioned to extend beyond a top surface of a mounting member  7  ( FIG. 2 ). In one embodiment, rods  22  include interior rods  22   a  and exterior rods  22   b . In suture winding device  100 , the plurality of rods  22  may be arranged to form a first array  20   a  and a second array  20   b . In one embodiment of suture winding device  100 , first array  20   a  and second array  20   b  are generally arcuate arrangements of exterior rods  22   b  that are spaced apart along a longitudinal axis of base  10 . 
     A needle holder  50  is disposed in a central region of mounting member  7  ( FIG. 2 ) and separates first array  20   a  from second array  20   b . Mounting member  7  is disposed on base  10  such that it abuts top surface  24 . Needle holder  50  is releasably disposed in mounting member  7  and includes a plate  52  having a plurality of buttons  54  disposed thereon. In an embodiment of suture winding device  100 , buttons  54  are arranged in pairs to form one or more needle channels  64 . Each needle channel  64  is configured and adapted for releasably engaging a needle  14  ( FIG. 5 ). Needle  14 , as is known in the art, has a sharpened tip at one end and a length of suture  16  extending from an opposing end. Disposed on one end of plate  52  are a post  56 , a needle guide  58 , and an end member  60 . Post  56  and end member  60  are spaced apart to form a suture channel  62  therebetween. Needle guide  58  in cooperation with buttons  54  position needle  14  in needle holder  50  such that suture  16  is releasably received in suture channel  62  ( FIG. 5 ). In one embodiment, suture  16  is positioned on mounting member  7  such that it contacts at least one interior rod  22   a  ( FIG. 5 ). Needle holder  50  may be replaced by alternate embodiments of the needle holder that are configured to receive single needles, double needles, or needles of varying diameters and dimensions regardless of whether the needles are in a single or double configuration. 
     A suture package or retainer  70  ( FIG. 17 ) is positionable on base  10  as illustrated in  FIGS. 6-8  and  15 . A suitable retainer  70  is the subject matter of U.S. patent application Ser. No. 10/891,604 filed on Jul. 15, 2004, currently owned and assigned to Tyco Healthcare Group, the contents of which are hereby incorporated by reference in their entirety. Referring now to  FIG. 17 , retainer  70  includes a first member  72  and a second member  74 . Second member  74  is adapted to attach to first member  72  as will be discussed in further detail below. 
     With reference to  FIG. 6 , first member  72  is shown disposed on mounting member  7  of base  10 . In one embodiment, the position of first member  72  with respect to mounting member  7  is maintained by vacuum connections  12  ( FIG. 1 ) that are disposed in base  10 . More specifically, vacuum applied through vacuum connections  12  holds first member  72  to vacuum ports  12   a . First member  72  is disposed on top of mounting member  7 . Positioned between first member  72  and mounting member  7  is needle  14  with a length of suture  16  attached thereto. First member  72  includes a plurality of throughholes  76  arranged to correspond with rods  22  ( FIG. 1 ) of base  10  thereby aligning needle holder  50  with a needle park or needle grip  80  of first member  72 . As shown in  FIG. 17 , first member  72  includes needle park  80  for releasably attaching needle  14  to first member  72 . Needle park  80  is positioned on first member  72  such that is aligned with needle holder  50  when first member  72  is positioned on plate  19  by the cooperative arrangement of rods  22  and throughholes  76 . As with needle holder  50 , needle park  80  may be replaced by alternate embodiments that are configured to receive single needles, double needles, or needles of varying diameters and dimensions regardless of whether the needles are in a single or double configuration. 
     Needle park  80  includes a number of tabs  82  and notches  84  that extend from a surface of first member  72  towards plate  19 . In one embodiment, needle holder  80  is disposed in a recess  86  on an underside of first member  72 . Each tab  82  and its corresponding notch  84  are configured and adapted for releasably gripping needle  14  such that when retainer  70  is removed from base  10 , needle  14  separates from needle holder  50  and is releasably attached to retainer  70  by needle park  80 . Tabs  82  and notches  84  are biased towards each other for releasably receiving needle  14 . A slot  78  is disposed along an edge of first member  72  where slot  78  communicates with recess  86  such that a portion of suture  16  may extend through recess  86  and be accessed from outside retainer  70 . 
     Transfer of needle  14  from needle holder  50  to needle park  80  is affected by forces applied by an operator in a generally downward direction (i.e. towards plate  19 ) on first member  72 . As first member  72  is urged towards plate  19  and needle holder  50 , needle  14  contacts needle park  80  with sufficient force to overcome the bias of tab  82  and notches  84 . By overcoming the bias of tabs  82  and notches  84 , the space between tab  82  and notches  84  is sufficient to receive needle  14 . After first member  72  has moved a predetermined distance, needle  14  no longer urges tab  82  and notches  84  away from each other whereupon the bias of tab  82  and notches  84  act to urge them towards each other for releasably retaining needle  14 . In configurations including more than one needle  14 , each set of tab  82  and notches  84  is configured as previously described. Alternatively, vacuum applied to first member  72  through vacuum ports  12   a  may supply the forces that urge needle  14  into releasable engagement with needle park  80  as previously discussed. In another embodiment, a combination of applied vacuum and operator action supply the forces for urging needle  14  into releasable engagement with needle park  80 . 
     Base  10  is rotatable such that suture  16  contacts each exterior rod  22   b  sequentially. As base  10  completes each rotation, a loop of suture  16  is formed about exterior rods  22   b . A predetermined amount of tension is maintained on suture  16  by a holder  30 . Holder  30  is mounted to support plate  1  and is rotatable with respect to base  10 . In one embodiment, holder  30  is rotatable amongst a plurality of positions including a loading position ( FIG. 1 ) and an unloading position ( FIG. 7 ). In addition, holder  30  is rotatable amongst the plurality of positions while base  10  is rotating about the central point (i.e. base  10  and holder  30  are independently positionable). 
     More specifically, holder  30  is attached to a mounting arm  42  ( FIG. 1 ) that is rotatably attached to plate  1  and is capable of being positioned in at least the loading position and the unloading position of holder  30  and, preferably may be positioned in any position therebetween. Further still, mounting arm  42  is capable of being positioned independently of base  10 . 
     In a further embodiment, as seen in  FIG. 6A , a suture winding device  90  includes a holder  92  that is rotatably attached to a plate  94  and movable through a plurality of positions, e.g. loading and unloading positions, as discussed above with respect to the embodiment depicted in  FIGS. 1-7 . In this embodiment, suture winding device  90  includes a programmable control module, actuator, or the like, generally designated by reference numeral  96 , that is operatively connected to holder  92  such that movement through the plurality of positions may be either manually or automatically regulated. 
     Referring again to  FIG. 6 , in the loading position, holder  30  orients suture  16  such that a desired angle between suture  16  and base  10  is achieved. In the unloading position, holder  30  orients suture  16  such that it is substantially parallel to the longitudinal axis of base  10 . The predetermined amount of tension applied to suture  16  is maintained by holder  30  regardless of its position relative to base  10  or whether or not base  10  is being rotated. 
     In particular and with reference to  FIGS. 3 and 4 , holder  30  includes a first arm  32  and a second arm  34 . First arm  32  is movable such that holder  30  may transition between an open state and a closed state while second arm  34  is stationary. In particular, second arm  34  is fixedly attached to a block  48  that is, in turn, fixedly attached to a mounting block  47  that is attached to a wall  40 . 
     Mounting block  47  includes an actuator and a slot  38  therein. Slot  38  is configured and dimensioned for slidably receiving a driver arm  36 . First arm  32  is attached to driver arm  36  such that movement of driver arm  36  results in corresponding movement of first arm  32 . In one embodiment, driver arm  36  is movable in slot  38  in a substantially vertical direction. In the open state, first arm  32  is spaced apart from second arm  34  defining a gap  45  therebetween ( FIG. 3 ). Gap  45  has sufficient dimensions such that suture  16  may be fed through gap  45  without contacting either first or second arms  32 ,  34 . 
     First arm  32  is moved towards second arm  34  during an actuation sequence such that first arm  32  substantially abuts second arm  34 . In one embodiment, first and second arms  32 ,  34  may include respective first and second cushioning members  32   a ,  34   a . During an actuation sequence, a pressure source is fluidly coupled to actuation ports  46  to provide the motive force to operate the actuator. Known pressure sources such as pneumatics (e.g. air, compressed gases, vacuum) or hydraulics (e.g. water, saline, oil) may be used with the actuator. In another embodiment, the actuator may be electrically powered by either AC or DC sources. Pneumatic, hydraulic, or electric actuators are well known to one skilled in this art and will not be discussed in detail herein. 
     Upon actuation, the actuator imparts motion to driver arm  36  to move driver arm  36  generally downward thereby transitioning it from its open state to its closed state. In the closed state, first arm  32  abuts second arm  34  and for slidably capturing a section of suture  16  therebetween. The amount of force exerted on suture  16  by first and second arms  32 ,  34  in the closed state is adjustable such that the amount of pressure applied is sufficient to allow suture  16  to be fed from a source to form the loops as base  10  rotates while maintaining the desired amount of tension on suture  16 . Additionally, the amount of pressure applied by first and second arms  32 ,  34  minimizes drooping of a length of suture  16  extending between holder  30  and first member  72  when base  10  is stationary. By providing holder  30  to supply a predetermined amount of tension to suture  16  during the winding process, suture  16  is disposed within retainer  70  with a substantially uniform amount of applied tension. Additionally, holder  30 , in cooperation with a uniform arrangement of rods  22 , supplies the desired amount of tension to suture  16  during the winding process thereby distributing suture  16  in retainer  70  in a substantially uniform arrangement. 
     In an alternate embodiment, one or both of the first and second arms of the holder are movable relative to each other. In this embodiment, as the holder transitions from the open state to the closed state, the first arm may move toward the second arm, the second arm may move toward the first arm, or both arms may move towards each other. A programmable control module, actuator, or the like, may be operatively connected to one or both of the first and second arms of the holder such that the approximation thereof may be manually or automatically regulated. 
     Referring still to  FIGS. 3 and 4 , after the desired number of loops are formed (i.e. the desired quantity of suture  16  is disposed on first member  72  of retainer  70 ), rotation of base  10  is halted. Holder  30  is moved from the loading position to the unloading position while still maintaining the desired tension on suture  16 . When holder  30  is in the unloading position, second member  74  is placed on top of first member  72 , thereby forming retainer  70  and securing needle  14  and attached suture  16  within retainer  70 . First arm  32  then transitions to its open state thereby releasing suture  16 . Suture  16  is then separated from its source by known techniques such as cutting and a free end of suture  16  is positioned along a surface of first member  72 . Alternatively, suture  16  may be separated from its source prior to transitioning first arm  32  to its open state. Throughholes  76  in second member  74  are arranged to correspond with and slidingly receive rods  22  thereby aligning first and second members  72 ,  74 . 
     In one embodiment, first and second members  72 ,  74  are press fit together using applied pressure to engage corresponding edge portions of respective first and second members  72 ,  74  as is known in the art. In another embodiment, first and second members  72 ,  74  are joined together using a heat stake  110 , such as those known in the art and illustrated in  FIG. 9 . Heat stake  110  includes a die plate  112  that is positionable along a vertical axis of heat stake  110 . After retainer  70  is assembled (i.e. second member  74  is placed on top of first member  72 ), base  10  and retainer  70  are positioned such that die plate  112  is in substantial vertical alignment with retainer  70  by moving plate  1  along a horizontal set of rails or guides  122  that are mounted on plate  120 . Plate  1 , including base  10 , is slidably attached to rails  122  using structures that are known in the art. In the alternative, base  10  may be stationary and heat stake  110  may be positionable along a horizontal set of rails or guides towards or away from base  10 . 
     Once die plate  112  and base  10 , particularly retainer  70 , are vertically aligned ( FIG. 10 ), one or both of base  10  or heat stake  110  is locked in position thereby maintaining the vertical alignment between retainer  70  and die plate  112 . Die plate  112  includes at least one heating element as is known in the art such that when die plate  112  contacts second member  74  with a desired amount of pressure, a combination of the desired amount of pressure and/or thermal energy from the heating element joins first and second members  72 ,  74  to form retainer  70  ( FIG. 10 ). In addition, die plate  112  includes a plurality of channels or tubes (not shown) configured and arranged for slidably receiving rods  22 . After first and second members  72 ,  74  are joined to form retainer  70 , die plate  112  separates from base  10  ( FIG. 11 ) allowing movement of plate  1  and removal of retainer  70  from base  10 . 
     A method of winding a needle or an armed needle using the hereinabove described suture winding device  100  will now be discussed in detail. With reference initially to  FIG. 5 , one or more needles  14  having a quantity of suture  16  attached thereto is positioned in needle holder  50 . Specifically, each needle  14  is positioned in a separate needle channel  64  and attached suture  16  is threaded between interior rods  22   a  and exterior rods  22   b  such that suture  16  is positioned between at least one interior rod  22   a  and at least one exterior rod  22   b . After threading suture  16  between interior and exterior rods  22   a ,  22   b , suture  16  extends beyond a top surface of mounting member  7 . First member  72  of retainer  70  is placed on mounting member  7  such that rods  22  align with throughholes  76 . Since rods  22  and throughholes  76  are configured for slidably engaging one another, a minimum amount of downward force is applied to position first member  72  in contact with the top surface of mounting member  7 . Suture  16  extends through slot  78  of first member  72  and is accessible from a region exterior to base  10 . 
     Once first member  72  of retainer  70  is positioned on mounting member  7 , vacuum may be applied through vacuum ports  12   a  thereby holding first member  72  in substantial contact with the top surface of mounting member  7 . Suture  16  is placed between first and second arms  32 ,  34  of holder  30  while first arm  32  is in the open state ( FIG. 3 ). After placing suture  16  between first and second arms  32 ,  34 , the actuator is energized by the selected power source (i.e. pneumatic, hydraulic, or electric) to transition first arm  34  from the open state to the closed state and slidably capturing a portion of suture  16  therebetween. 
     Base  10  is rotated as suture  16  is fed from a source (not shown) thereby winding a quantity of suture  16  around rods  22  forming loops of suture  16 . After a desired quantity of suture  16  is disposed on first member  72 , rotation of base  10  is halted. Holder  30  is then positioned from its loading position shown in  FIG. 6  to its unloading position in  FIG. 7 . By maintaining suture  16  between arms  32  and  34  of holder  30  as it transitions from its loading position to its unloading position, a desired amount of tension is maintained on suture  16  prior to joining first and second members  72 ,  74  of retainer  70 . The desired quantity of suture  16  that is disposed on first member  72  may then be separated from the source of suture  16  by cutting or other techniques known in the art. The separated end of suture  16  is positioned along the top surface of first member  72  prior to placing second member  74  atop first member  72 . 
     After second member  74  is positioned on top of first member  72 , pressure and/or heat may be used to form retainer  70  by joining first and second members  72 ,  74 . As seen in  FIG. 9 , the assembled retainer  70  sits atop base  10  and plate  1 . Plate  1  may be moved along rails  122  for positioning plate  1  and base  10  in alignment with die plate  112  such that vertical movement of die plate  112  will contact second member  74  of retainer  70  to apply a desired amount of pressure and/or thermal energy to join first and second members  72 ,  74  ( FIG. 10 ). Channels (not shown) in die plate  112  slidably receive rods  22  as die plate  112  contacts second member  74 . After joining first and second members  72 ,  74 , die plate  112  is moved away from base  10  in a generally vertical direction ( FIG. 11 ) such that base  10  and retainer  70  may be moved along rails  122 . Retainer  70  is now formed and includes needle  14  and the desired quantity of suture  16 . The steps are repeatable for each retainer  70  to be formed. 
     Referring now to  FIGS. 12A-13B , in another embodiment, an apparatus  200  for packaging a suture  216  includes a base member  210 , at least one rod  222  arranged in at least one array  220 , a retainer package  270 , and a holder  230  having first and second arms (not shown). Each of these elements is substantially similar to those described above with respect to the previous embodiments and have been renumbered accordingly. For the sake of brevity, only the differences between the embodiments will be discussed in detail. In this embodiment, apparatus  200  further includes a parking mechanism  240  and at least one positioning rod  260 . 
     Parking mechanism  240  maintains a pre-determined orientation of a tail portion  216   a  of suture  216  during the winding process, as discussed in further detail below, and includes an attachment member  242  and first and second arms  244 ,  246 , respectively. 
     Attachment member  242  is any plate, strut, rod, or other structure suitable for the intended purpose of associating parking mechanism  240  with apparatus  200 . In the embodiment depicted in  FIGS. 12A-12B , attachment member  242  is fixedly supported on a heat stake apparatus  280  similar to that which was discussed above with respect to the embodiment depicted in  FIGS. 9-11 . The attachment member  242  may be movably supported on the heat stake apparatus  280 . Additionally, the attachment member  242  may be either fixedly or movably supported to the apparatus  200  itself at any suitable location, e.g. the base member  210 , or to any other structure suitable for the intended purpose of facilitating the operation of the parking mechanism  240 , as described in further detail below. 
     Referring still to  FIGS. 12-12B , second arm  246  is movably connected to attachment member  242  such that parking mechanism  240  is free to pivot, rotate, slide, or the like, between a first position ( FIG. 12A ) and at least one subsequent position ( FIG. 12B ). Movement of parking mechanism  240  between the first position and the at least one subsequent position may be facilitated through any suitable structural mechanism, e.g., a hinge or a pivot. 
     In the first position ( FIG. 12A ), parking mechanism  240  is oriented so as not to engage suture  216 . In the at least one subsequent position ( FIG. 12B ), parking mechanism  240  is reconfigured to facilitate engagement with at least a portion, e.g. tail portion  216   a , of suture  216 , as described in further detail below. The parking mechanism may be operatively associated with a programmable control module, actuator, or the like, such that movement from the first position to the at least one subsequent position may be manually or automatically regulated. 
     Alternatively, the attachment member may be fixedly attached to the apparatus such that the radial, lateral, or rotational movement of the parking mechanism is substantially prevented. As such, the parking mechanism remains substantially stationary and, accordingly, does not transition between the first and second positions discussed above. 
     Parking mechanism  240  includes respective first and second arms  244 ,  246 . In one embodiment, first arm  244  is movable in relation to second arm  246  such that parking mechanism  240  may transition between an open condition ( FIG. 13A ) and a closed condition ( FIG. 13B ), while second  246  is stationary. 
     Second arm  246  includes a slot  248  defined therein that is configured and dimensioned to slidably receive a portion of first arm  244 . In the open condition, first arm  244  is spaced apart from second arm  246  such that a space  250  is defined therebetween that is dimensioned to receive at least a portion of suture  216 , e.g. tail portion  216   a . First arm  244  is approximated relative to second arm  246  during an actuation sequence until first arm  244  substantially abuts second arm  246 , thereby closing off space  250  in the closed condition, and releasably retaining tail portion  216   a  of suture  216  therein. 
     In another embodiment, the parking mechanism may be operatively connected to a programmable control module, actuator, or the like such that the transition from the open condition to the closed condition may be manually or automatically regulated. 
     As seen in  FIGS. 12B and 13B , when parking mechanism  240  is in the second position and the closed condition, tail portion  216   a  of suture  216  in oriented and maintained in desired, pre-determined manner with respect to base member x defined by angle Φ, as discussed in further detail below. Angle Φ may be any angle substantially within the range of 0° to 180°. 
     In one embodiment, the present disclosure contemplates that both the first and second arms of the parking mechanism are movable. As the parking mechanism transitions from the open condition to the closed condition, the first and second arms approximate relative to one another. 
     As indicated above, apparatus  200  also includes at least one positioning rod  260  that is extendable at least partially through an aperture  212  formed in base member  210  and retainer package  270 . Positioning rod  260  includes a tip  262  and is movable from a first or retracted position, seen in  FIG. 12A , in which tip  262  is substantially flush with or below base member  210 , to a second or extended position, seen in  FIG. 12B , in which positioning rod  260  is configured to engage tail portion  216   a  of suture  216 . In the extended position, positioning rod  260  ensures that tail portion  216   a  remains in the pre-determined orientation, as discussed above, until assembly of the retainer package  270  is complete. In one aspect of the present disclosure, the parking mechanism and the positioning rod cooperate to orient the tail portion of the suture within a perimeter of the retainer package. 
     The positioning rods may be operatively connected to a programmable control module, actuator, or the like, such that the transition of the positioning rod between the first or retracted position and the second or extended position may be either manually or automatically regulated. 
     A method of winding a suture  216  using apparatus  200  will be discussed. Prior to the formation of loops “L” of suture  216  about rods  222 , the method described hereinbelow is substantially identical to that which was discussed above, and will therefore not be repeated. During and immediately prior to the formation of loops “L”, parking mechanism  240  is in the first position ( FIG. 12A ) and in the open condition ( FIG. 12B ). Subsequent to the formation of loops “L”, parking mechanism  240  transitions both into the second position ( FIG. 12B ), so at to facilitate engagement with tail portion  216   a  of suture  216 , and the closed condition ( FIG. 13B ), thereby releasably capturing tail portion  216   a  within space  250 . 
     After positioning parking mechanism  240  in the second position and the closed condition, positioning rod  260  is extended from the retracted position ( FIG. 12A ), such that tip  262  extends at least partially beyond base  210 , thereby facilitating engagement of positioning rod  260  with tail portion  216   a  of suture  216 . In the extended position, positioning rod  260  cooperates with parking mechanism  240  to configure tail portion  216   a  of suture  216  in the predetermined orientation, as discussed above. 
     Referring now to  FIGS. 14A-14C , another embodiment of the suture winding device is illustrated and shown generally as  300 . Suture winding device  300  includes a base  310  that is rotatably mounted to a plate  301 . Holder  30 , that was discussed in detail previously with reference to  FIGS. 3-4 , is rotatably mounted to plate  301 . Base  310  is a generally elliptical structure that includes a frame  318  and a plate  319  that is attached to a mounting surface  326  of frame  318 . A mounting member  307  is disposed atop plate  319  and provides a surface suitable for positioning a first member  372  of a retainer. Mounting member  307  includes needle holder  50  as previously shown and described with reference to  FIG. 2 . As in the previous embodiment, needle  14  has a quantity of suture  16  attached thereto and is disposed in needle holder  50 . A portion of suture  16  extends beyond base  310  and is threaded through first and second arms  32 ,  34  of holder  30 . 
     Suture winding device  300  includes a plurality of rods  322  that is extendable through throughholes  376  of first member  372  where each rod  322  includes a tip  323 . In this embodiment, rods  322  are positionable between a first or retracted position and a second or extended position as shown in  FIGS. 14A-14C . It is contemplated that the suture winding device may include a programmable control module, an actuator, or the like, operatively connected to the rods such that the transition between the first or retracted position and the second or extended position may be either manually or automatically regulated. When in the extended position, rods  322  are capable of forming one or more loops of suture  16  as will be discussed in detail hereinbelow. In the retracted position, tips  323  of rods  322  are substantially flush with a top surface of mounting member  307 . Alternatively, tips  323  may exist below the top surface of mounting member  307 . In addition, rods  322  are arranged in one or more arrays  330 . Each array  330  includes a plurality of rods  322  that are arranged in one or more arcs  340  of rods  322 . Furthermore, in an embodiment having two arrays  330 , the arrays  330  are spaced apart along a longitudinal axis of base  310 . Similar to suture winding device  300 , arrays  330  are spaced apart about needle holder  50 . Needle holder  50  is releasably mounted in mounting member  307  such that a top surface of plate  52  is substantially flush with the top surface of mounting member  307 . As in the previous embodiment, needle holder  50  may be replaced by alternate embodiments of the needle holder that are configured to receive single needles, double needles, or needles of varying diameters and dimensions regardless of whether the needles are in a single or double configuration. 
     In  FIG. 14A , rods  322  are shown in the extended position and each array  330  includes an arc  340  of rods  322 . Additional arcs  340  are illustrated in  FIGS. 14B-14C . In  FIG. 14B , each array  330  includes two arcs ( 340   a ,  340   b ) while  FIG. 14C  illustrates suture winding device  300  with three arcs ( 340   a ,  340   b ,  340   c ) in each array  330 . The spatial arrangement and relationship of rods  322 , arrays  330 , and arcs  340  will now be discussed in further detail. Moving from needle holder  50  towards an outer edge of mounting member  307 , arcs  340  have successively larger radii such that rods  322  in arc  340   a  (i.e. closest to needle holder  50 ) are spaced closer together than rods  322  in arc  340   b  ( FIG. 14B ). In an embodiment including three arcs ( FIG. 14C ), arc  340   c  is spaced further away from needle holder  50  than arc  340   b  and has a larger radii than arc  340   b  or  340   a  such that rods  322  in arc  340   c  are spaced further apart than rods  322  in arc  340   a  or  340   b . In addition, in configurations using more than three arcs, the radius of each arc increases as each arc is spaced further away from needle holder  50  towards the outer edge of mounting member  307  thereby increasing the distance between rods  322  in each arc. 
     As previously mentioned, rods  322  are positionable between a retracted position and an extended position. Each rod  322  may be independently positionable. In one embodiment, rods  322  in each arc ( 340   a ,  340   b , or  340   c ) are positionable as a group such that all rods  322  in each arc ( 340   a ,  340   b , or  340   c ) move substantially simultaneously. In addition, in embodiments having two arrays  330 , arcs may be positioned sequentially such that rods  322  in arc  340   a  are moved substantially in unison from the retracted state to the extended state or vice versa. Furthermore, additional arcs  340   b ,  340   c  are positioned similarly such that corresponding arcs in each array  330  (i.e. arc pairs  340   a ,  340   a  or  340   b ,  340   b  or  340   c ,  340   c ) are moved substantially simultaneously. 
     Operative force to transition rods  322  from the retracted to the extended position or the extended to the retracted position may be supplied by mechanical, hydraulic, pneumatic, or electric sources as are well known to those of skill in the art. In one embodiment, rods  322  are transitioned from their positions using a number of cams and/or levers. Alternately, hydraulic force supplied by water or oil, pneumatic force supplied by air or other compressed gasses, or electric force supplied by motors or solenoids may be substituted for or combined with the cams and/or levers. 
     A method of winding a needle or an armed needle using the hereinabove described suture winding device  300  will now be discussed in detail. With reference initially to  FIG. 14A , each array  330  has rods  322  of arc  340   a  in their extended position. One or more needles  14  having a quantity of suture  16  attached thereto is positioned in needle holder  50  as discussed in detail above with reference to  FIG. 5  and first member  372  is placed on mounting member  307  such that rods  322  in the extended position align with throughholes  376 . Since rods  322  and throughholes  376  are configured for slidably engaging one another, a slight amount of downward force is required to position first member  372  in contact with the top surface of mounting member  307 . Suture  16  extends through slot  378  of first member  372  such that it is accessible from an outside region. Subsequently, suture  16  is positioned such that a portion of suture  16  contacts one or more of rods  322  in arc  340   a.    
     Suture  16  is then placed between first and second arms  32 ,  34  of holder  30  while first arm  32  is in the first state ( FIG. 3 ). After placing suture  16  between first and second arms  32 ,  34 , the actuator is energized by the selected power source (i.e. pneumatic, hydraulic, or electric) to transition first arm  34  from the first state to the second state (i.e. towards second arm  34 ) and slidably capturing a portion of suture  16  therebetween. 
     Base  310  is rotated on plate  301  such that a desired quantity of suture  16  is wound about rods  322  in arcs  340   a  forming loops of suture  16  ( FIG. 14A ). After one or more loops are formed about arcs  340   a , rods  322  in arcs  340   b  may be transitioned to their extended position ( FIG. 14B ) while base  310  continues to rotate on plate  301  and rods  322  in arcs  340   a  remain in their extended position. Once rods  322  of arcs  340   b  are transitioned to their extended positions, suture  16  now forms loops only about arcs  340   b  without forming additional loops about arcs  340   a . After one or more loops of suture  16  are formed about arcs  340   b , rods  322  in arcs  340   c  may be transitioned to their extended position ( FIG. 14C ) while base  310  continues to rotate. As base  310  rotates, one or more loops of suture  16  are only formed about arcs  340   c  without forming additional loops about arcs  340   a  or  340   b . While loops of suture  16  are forming about arcs  340   c , rods  322  in arcs  340   a  and  340   b  remain in their extended position maintaining the previously formed loops of suture  16 . 
     After a desired quantity of suture  16  is disposed on first member  72 , rotation of base  310  is halted. Holder  30  is then positioned from its loading position shown in  FIG. 14A  to its unloading position in  FIG. 14C . By maintaining suture  16  between arms  32  and  34  of holder  30  as it transitions from its loading position to its unloading position, a desired amount of tension is maintained on suture  16  prior to forming retainer  70 . The desired quantity of suture  16  that is disposed on first member  372  may then be separated from the source of suture  16  by cutting or other techniques known in the art. The separated end of suture  16  is positioned along the top surface of first member  372  prior to placing a second member of retainer atop first member  372  similar to the formation of retainer  70  in the previously discussed embodiment. 
     Joinder and formation of retainer  70  is substantially similar to that of the previous embodiment using pressure and/or thermal energy from heat stake apparatus  110  as illustrated in  FIGS. 9-11  and discussed previously. 
     In another embodiment, holder  30  is attached to a rail assembly  400  as shown in  FIGS. 14-15 . Holder  30  was previously described with reference to  FIGS. 3-4 . In this embodiment, holder  30  is positionable on rail assembly  400  rather than being rotatably mounted to plate  1  using mounting arm  42  as in the previous embodiment. 
     Rail assembly  400  includes a carriage  410  that is slidably mounted to rail  420  using structures and techniques known to those of skill in the art. Holder  30  is attached to carriage  410  thereby allowing holder  30  to be positioned along rail  420  throughout a plurality of positions including a loading position ( FIG. 15 ) and an unloading position ( FIG. 16 ). Holder  30  and rail assembly  400  are adapted for use with any of the embodiments disclosed herein, i.e. suture winding device  100  is shown in  FIGS. 15-16  for illustrative purposes only. 
     As suture  16  is wound onto suture winding device  100 , as previously shown and described, carriage  410  and holder  30  move along rail  420  from the loading position to the unloading position. Movement of carriage  410  is coordinated and synchronized with the rotation of suture winding device  100  such that the desired amount of tension is maintained on suture  16  during the winding process. After the desired amount of suture  16  is wound onto suture winding device  100  (i.e. holder  30  is in the unloading position), suture  16  may be separated as discussed previously with reference to suture winding device  100 . 
     Joinder and formation of retainer  70  is substantially similar to that of the previous embodiment using pressure and/or thermal energy from heat stake apparatus  110  as illustrated in  FIGS. 9-11  and discussed previously. 
     It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.