Abstract:
A machine and process for packaging armed sutures into tray packages. The machine has a frame with a rotatable indexing disc member mounted to the top of the frame. A plurality of tool nests are rotatably mounted to the top of the indexing disc. Tray packages mounted in the toll nests are rotated to wind sutures into a suture channel in the packages. A stylus having a front nose member and a rear heel member guides suture into the suture channel. Channel winding pins in the winding tooling provide for an arranged wind of suture in a suture channel of the tray packages. The machine has an in-line printer and a punching machine for printing and punching paper covers from strips of stock material, which are then mounted to the tray packages.

Description:
TECHNICAL FIELD 
     The field of art to which this invention relates is packaging machinery, more specifically, packaging machinery for packaging surgical needles and sutures, and methods of packaging surgical needles and sutures. 
     BACKGROUND OF THE INVENTION 
     Surgical sutures having surgical needles attached to one or both ends are well known in the medical arts. Sutures having a single needle attached to one end are known as single-armed sutures, while sutures having needles attached to both ends are known as double-armed sutures. Sutures not having surgical needles mounted to either end are referred to as unarmed sutures. Double-armed sutures find particular utility in the following types of surgical procedures: cardiac valve replacement surgery, cardiac surgery, and bowel surgery. 
     In the past, surgical sutures were hand packaged into specially designed suture packages. Typically, the sutures were wound using conventional winding fixtures having winding pins. Although there may have been advantages associated with the hand winding methods of the prior art, one major disadvantage was that they were unnecessarily time consuming. In order to maintain high quality and to reduce costs, manufacturers of surgical sutures and surgical needles have developed high-speed packaging processes for packaging surgical needles and sutures into specially designed packages. Packages for surgical needles and sutures are well know in the art The packages range from simple folder packages to more complex, molded tray packages suitable for automated, high speed winding and packaging processes. A typical tray package has a winding channel in which the suture is contained. Various moveable doors or hinged members are used to cover the winding channel to maintain the wound suture in place. The tray packages typically have a needle park to retain surgical needles that are mounted to one or both ends of the surgical needles. The sutures are wound into the winding channels by mounting the trays in a rotatable nest member, and rotating the nest and tray while using a stylus member to direct and locate the suture in the channel in a wound pattern. Examples of packages which can be used in high speed winding applications are contained in U.S. Pat. Nos. 5,213,210, 5,236,083, 5,284,240, 6,098,796, and 6,135,272, the disclosures of which are incorporated by reference. High speed winding machines for packaging surgical sutures in such surgical suture packages are disclosed for example in U.S. Pat. Nos. 5,664,404 and 6,032,343 which are incorporated by reference. 
     Although the packaging machines and processes of the prior art are adequate for their intended use, there are certain types of surgical sutures which are particularly difficult to adapt to high speed winding or packaging machine operations. For example, suture for use in cardiac and cardiovascular surgical procedures is very delicate and any damage caused to the suture by handling or packaging can compromise the integrity of the sutures. In addition, it has been difficult to package such sutures in packages using high-speed automatic packaging machinery due in part to the fine gauge of the sutures. Also, it previously has not been possible to package double armed sutures in tray packages using high-speed winding equipment. 
     Accordingly, there is a need in this art for novel high-speed packaging machinery and processes for packaging surgical needles and sutures. There is a constant need in this are for novel winding apparatuses and methods to provide for high packaging throughputs, while maintaining the quality and integrity of the surgical sutures and the packages. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide novel packaging machines and methods to efficiently and effectively load surgical sutures into a tray package having a suture winding channel in such a way that the sutures are not damaged during the loading process, and such that the sutures dispense easily in the field without damage to the suture. 
     It is further object of the present invention to provide a machine and a process for electronically printing and affixing a cover to a tray package having a suture winding channel with a surgical suture wound in the channel, and then optionally loading the packages with the labels into magazines that are suitable for automatic processing in downstream operations. 
     Accordingly, an apparatus or machine for winding surgical sutures into tray packages is disclosed. The apparatus has a machine frame having a top, a bottom, sides and an interior. A disc member is rotatably mounted to the top of the frame, the disc member has a periphery, top, a bottom and a side about the periphery of the disc member. There are a plurality of tool nests. Each tool nest is rotatably mounted to the top of the disc member. Each such tool nest has a nest frame, having a top, a bottom and sides. At least two winding pin members extending up from the top of the nest frame. A rotatable tool is mounted to the machine frame, said tool being displaceable downwardly to engage with the pin members on the nest frame, such that rotation of the tool will rotate the tool nest, wherein said rotatable tool has a top and a bottom. A plurality of channel winding pin members extend down from the bottom of the rotatable tool. There is a cam track member that extends down from the bottom of the rotatable tool. The cam track member has a pair of opposed longitudinal sides and a pair of opposed curved ends connecting the longitudinal sides. The cam track member has a first width along the longitudinal sides and a second width along the curved ends, wherein the first width is greater than the second width. A stylus member is movably mounted to the machine frame, for cooperation with the tool nests. The stylus member has a stylus frame having a top, sides and a bottom. A stylus is mounted to the bottom of the stylus frame having a front nose member and a rear heel member separated by a suture opening. The stylus has a top surface and a bottom surface. A door dosing member extends down from the bottom of the stylus frame adjacent to the stylus. The stylus member operatively engages the cam track member. Optionally, the packaging machine has an in-line printer associated therewith for printing package covers, and, a punching apparatus for punching printed covers from a printed strip of cover material. 
     Yet another aspect of the present invention is the combination of a suture tray package and a packaging machine. The packaging machine has a machine frame having a top, a bottom, sides and an interior. A disc member is rotatably mounted to the top of the frame. The disc member has a periphery, top, a bottom and a side about the periphery of the disc member. There are a plurality of tool nests, each tool nest is rotatably mounted to the top of the disc member. Each tool nest has a nest frame, having a top, a bottom and sides. At least two winding pin members extend up from the top of the nest frame. A rotatable tool is mounted to the machine frame. The rotatable tool is capable of being displaced downwardly to engage with the pin members on the nest frame, such that rotation of the tool will rotate the tool nest The rotatable tool has a top and a bottom. A plurality of channel winding pin members extend down from the bottom of the rotatable tool. There is a cam track member that extends down from the bottom of the rotatable tool. The cam track member has a pair of opposed longitudinal sides and a pair of opposed curved ends connecting the longitudinal sides. The cam track member has a first width along the longitudinal sides and a second width along the curved ends, wherein the first width is greater than the second width. A stylus member is movably mounted to the machine frame, for cooperation with the tool nests. The stylus member has a stylus frame having a top, sides and a bottom. A stylus is mounted to the bottom of the stylus frame. The stylus has a front nose member and a rear heel member separated by a suture opening. The stylus has a top surface. A door closing member extends down from the bottom of the stylus frame adjacent to the stylus. The stylus operatively engages the cam track member. The suture tray package has a top and a bottom. The tray package has a flat base member having a top and an outer periphery. An outer wall extends up from the base member about the periphery of the base member. An inner wall, interior to the outer wall, extends up from the top of the base member, said inner wall has a top, and the inner wall is spaced away from the outer wall to form a suture channel. A plurality of door members extends out from the top of the inner wall over the winding channel, each such door member has a proximal end and a distal end, and opposed sides. There are a plurality of openings between at least some of the door members for receiving channel winding pin members. At least two needle park members extend up from the top of the base member. The needle park members are located interior to the inner wall. The tray package is mounted in a tool nest. The packaging machine of the combination can optionally have an in-line printer associated therewith for printing package covers, and, a punching apparatus for punching printed covers from a printed strip of cover material. 
     The tray package of the combination can optionally have a cover for mounting to the top of the package. 
     Still yet another aspect of the present invention is a method of loading and winding a surgical needle and suture assembly into a tray package having a suture channel using the packaging machines of the present invention. 
     These and other aspects and features and advantages of the present invention will become more apparent from the following description and accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a plan view of a surgical suture having a surgical needle mounted to one end thereof. 
     FIG. 2 is a plan view of a tray package having a suture winding channel and a needle park, with the needle and suture of FIG. 1 contained therein. 
     FIG. 3 is a magnified partial view of the package of FIG. 2 illustrating the needle mounted in the needle park. 
     FIG. 4 is a cross-sectional view taken along View Line  4 — 4  of the package of FIG.  2 . 
     FIG. 5 is an exploded side view of the package and suture of FIG.  2 . 
     FIG. 6 is a plan view of a packaging machine of the present invention. 
     FIG. 7 is a plan view of illustrating the machine indexing turret and a plurality of tool nests thereon, of the packaging machine of FIG. 6 
     FIG. 8 is an enlarged plan view of a tool nest of FIG.  7 . 
     FIG. 9 is a magnified view illustrating the machine top the packaging machine of FIG.  6 . 
     FIG. 10 is a schematic side view of a winding station used in the packaging machines of the present invention, illustrating the major elements thereof. 
     FIG. 11 is a perspective view illustrating a winding stylus assembly used with the packaging machines of the present invention to guide suture into a channel of a tray package. 
     FIG. 12 is a plan view of a tray package adapted for use with the packaging machines of the present invention, partially cut-away to illustrating the suture channel of the package and channel winding pins. 
     FIG. 13 is a magnified, cross-sectional view of the package of FIG. 12 taken along View Line  12 — 12 , illustrating a channel winding pin of FIG. 11 in the suture channel during a suture winding operation. 
     FIG. 14 is a plan view of the package of FIG. 2, having a partial cut-away illustrating the relaxation of the suture loops in the suture channel after channel winding pin removal. 
     FIG. 15 is an illustration of a tray package having a suture channel, and having a stylus of the machine of the present invention inserted in the channel. 
     FIG. 16 is a side, cross-sectional view taken along View line  16 — 16  of the package of FIG.  15 . 
     FIG. 17 is a magnified view of the package of FIG. 16, illustrating the stylus in the channel. 
     FIG. 18 is a plan view of the rotational and stylus components of the winding station of the packaging machine of the present invention. 
     FIG. 19A is a magnified plan partial view of the stylus and package of FIG.  18 . 
     FIG. 19B is a plan view of the stylus guiding cam track and related mechanical components of the winding station of FIG.  19 A. 
     FIG. 19C illustrates the stylus guiding cam track and related mechanical components of FIG. 19B rotationally displaced during a winding operation. 
     FIG. 20 is a detailed, plan view illustrating the winding machine top of FIG.  9 . 
     FIG. 21 is a plan view of an assembled suture tray package containing a surgical needle and suture prior to assembly of a paper cover. 
     FIG. 22 is a plan view of the assembled suture package of FIG. 21, after assembly of a paper cover. 
     FIG. 23 is a plan view of a paper cover prior to printing by a machine in-line printer, illustrating the staking tabs die-cut therein. 
     FIG. 24 is a plan view of the paper cover of FIG. 23 illustrating the cover after printing by the machine in-line printer. 
     FIG. 25 is a plan view of a paper strip used to manufacture the covers of FIGS. 23 and 24, before and after printing. 
     FIG. 26A is a partial, magnified plan view of the paper cover strip of FIG. 25 illustrating the die cutting thereon. 
     FIG. 26B is a plan view of a paper cover strip typically produced by a conventional layout for a rotary converting press. 
     FIG. 26C is a plan view of a paper cover strip having a sprocket feed approach for a rotary converting press. 
     FIG. 26D is a plan view of a preferred embodiment of a paper cover strip useful with the packaging machines of the present invention, illustrating design features to minimize paper waste. 
     FIG. 27 is a plan view of the printed paper strip of FIG. 25, illustrating a cover punched-out from the strip at the machine cover feed station, and the processed strip with openings remaining thereafter. 
     FIG. 28 illustrates a paper cover prior to staking onto a package. 
     FIG. 29 illustrates the paper cover of FIG. 28 after staking onto a package. 
     FIG. 30 is a side, partial cross-sectional magnified view of the package of FIG. 29 taken along View Line  30 — 30  illustrating the staking tab function and features. 
     FIG. 31 is a partial, magnified plan view of the machine of FIG. 20, illustrating the machine operation for package completion and off-load. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The machines and processes of the present invention are preferably useful to package conventional surgical sutures and needles into tray packages having winding packages. The sutures may be armed, that is, having a conventional surgical needle mounted to one or both ends, or may be un-armed without a surgical needle on either end. 
     Surgical sutures and packages assembled by the machines and processes s of the present invention are described herein are illustrated in FIGS. 1-5. Referring first to FIG. 1, an armed surgical suture with attached needle assembly  5  is illustrated. The assembly  5  is seen to have surgical suture  20  having distal end  24  and proximal end  22 . Assembly  5  is also seen to have surgical needle  10  having pointed distal end  14  and proximal suture mounting end  12 , as well as midpoint  19  and needle body  15 . The distal end  24  of suture  20  is seen to be mounted to the proximal end  12  of surgical needle  10 . 
     A molded package tray  30  having a winding channel to contain the suture assembly is seen in FIG.  2 . Referring also to FIG. 3, the package tray  30  is seen to have a planar base  40 , parallel sides with essentially semicircular ends  48 , and having top  41  and bottom  42 . An outer wall  50  extends up from base  40  about the outer periphery of base  40 . Spaced inward from outer wall  50  and substantially parallel thereto is inner wall  60  that extends up from top  41  of base  40 . Outer wall  50 , inner wall  60 , and a section of top  41  A partially define a suture winding channel  70  having bottom  72 . A plurality of flexible flap members  80  are seen extending generally radially outward and sloping downward from the top  62  of inner wall  60  over and into winding channel  70 . Referring to the cross-sectional view of FIG. 4, the flaps  80  extend to a distal end  82  that contacts the outer wall  50  where it meets with a radiused profile inner surface  74  of bottom  72 . The top surface  41  of package base  40 , the inner surface of outer wall  50 , the outer surface of inner wall  60 , and the flap members  80  completely define the winding channel  70  which confines suture strands  28  of suture  20 . 
     The package tray  30  is made of resilient material such as plastic, thereby affording properties to the flap members  80  that allow them to be mechanically hinged, about their connection areas or hinges  86 , upwardly to position  88  shown in dashed line illustration, and when released, spring back to essentially their resting downward sloping position. Molded slots  85  are seen to separate the individual flaps  80 , allowing them to be individually flexed open as illustrated in FIG. 4, with adjacent flaps  80  remaining closed. Sequentially opening and closing the flaps  80  allows the suture  20  to be wound into the winding channel  70  by the machines and methods of the present invention. 
     Located in the lower central portion of the package tray  30  is the needle holding structure  100 , referred to herein and conventionally in the art as a “needle park”. Needle park  100  is seen in FIGS. 3 and 4. Needle park  100  is seen to have cantilevered members  110  and stationary members  120  separated by gap  105 . The loading of a needle  10  into the needle park  100  is done by pressing the needle body  15  in a direction perpendicular to the tray base  40  at roughly the mid-point  17  of the needle, against upper chamfered sections  116  and  126  of members  110  and  120 , respectively, causing the cantilevered member  110  to flex away from the stationary member  120  while maintaining a spring force or bias against the needle body  15 , thereby securing by a frictional force the needle  10  in needle park  100  against dislodging due to subsequent exposure to package handling or shipping vibration. 
     Preferably, the package  10  is itself assembled from multiple components to form an assembled tray package that can be loaded with a surgical suture assembly  5 . As seen in FIG. 5, the components include the previously described base member  40  to which is mounted a cover member  90 . These components are assembled and fastened in combination with an upstream molding process, said assembly operations are not relevant to the package machine described herein, to make the package tray  30 . A paper cover  650  is printed and affixed to the top of the package tray  30 , after suture assembly  5  is loaded. Also illustrated in FIG. 5 is the coiled suture  20  and the needle  10 . 
     A particularly preferred embodiment of a packaging machine of the present invention is seen in FIG.  6 . The zipper package assembly machine  200  is a rotary index type combined with linear motions to transport the package through its assembly sequence. The machine  200  is seen to include a machine frame and enclosure  210 , a main rotary indexing disc shaped turret  250 , an equally spaced plurality of tool nests  270  rotatingly mounted thereon, an electronic controls enclosure  300 , a machine top tool plate  310  with feeding and assembly stations positioned and fixedly mounted thereto. 
     The operating functions on the machine  200  described in more detail hereinbelow are the molded tray hopper and feeding station  330 , suture load station  350 , winding station  370 , transfer station  430 , paper lid strip feed container  450 , paper lid printer  460 , lid punch and feed station  470 , lid assembly station  490 , paper lid scrap bin  510 , accept/reject station  520 , demagnetization station  530 , magazine hopper  540 , magazine load station  550 , empty magazine feed station  560 , and completed product magazine discharge station  570 . The feeding of suture assemblies  5  to the machine can be done manually, as illustrated for example by operator  580 , or automatically by robot or other device (not shown). 
     Referring now to FIG. 7, the indexing turret  250  and a plurality of identical tool nests  270  equally spaced around the periphery thereon are seen. The turret  250  is mounted rotatingly to frame  210  about a vertical turret axis  251 . The turret  250 , comprising four tool nests  270  in the preferred embodiment, moves in an index rotation 90° counterclockwise at each machine cycle. 
     An enlarged plan view of the machine.  200  of FIG. 6 is seen in FIG.  9 . The first station  330  loads an empty molded tray package  30  from a vertical stacking hopper  332  with a shuttle slide (not shown). The vertical stack of moldings  30  is contained by a plurality of fixed vertical rods that confine the moldings  30  by guiding on their outer edges, allowing the packages  30  to descend by gravity, being singulated and translated horizontally from the bottom of the stack by a typical slice type shuttle (not shown) as the machine is cycled. The shuttle gripper (not shown) places the empty molded tray  30  over winding pins  272  and  273  (See FIG.  8 ), so that corresponding slot  38  and hole  39  respectively in the tray  30  are coincident therewith. 
     The needle and suture assembly  5  are loaded into package  30  at station  350  as seen in FIG. 7, either manually or automatically. An enlarged view of the tooling nest  270  of FIG. 7 is seen in FIG. 8, illustrating a package tray  30  indexed into position from station  330  and after the needle and suture assembly  5  been inserted therein at station  350 . As illustrated, the needle  10  is been pressed vertically downward into in the needle park  100 , and the suture  20  is guided around the winding pin  272 , over the winding stylus base  281  of winding stylus  290 , against the stylus base pin  283 , and under the friction hold down  285 . Hold down weight block  285  exerts a gravitational force against a corresponding platform top surface  286  through resilient elastic bands  287  stretched therearound, thereby frictionally fixing the position of suture strands  20  therebetween. Elastic bands  287  are manufactured of soft, rubber-like material, to prevent damage to the suture strands  20 . The winding pin  272 , the stylus base pin  283 , and the hold down vertical shaft  288 , are positioned to locate the suture strand  20  through the gap  35  in the tray inner wall and generally within the stylus access opening  36  in the tray suture channel. The trailing end or loop  29  of the suture  20  beyond the hold down  285  hangs freely or is controlled by other means not part of the machine. 
     Referring to FIG. 9, the winding operation commences after the turret  250  indexes 90° counter clockwise, thereby moving the tool nest  270  and package  30  with needle and suture assembly  5  loaded at suture loading station  350  to suture winding station  370 . The free suture trailing end  29  is pulled along by the 90° counter-clockwise index rotation of the turret  250  to a position  369  in proximity of the winding turret position  370 , guided by a fixedly mounted trough  365  that is fabricated with a smooth surface  366  to prevent suture damage. 
     The details of the turret  250  are illustrated in FIG.  7 . Each of the four tooling nests  270  are rotatable about their individual vertical axes, for example axis  271  for nest  270  at suture winding station  370 , after a rotational latch within the turret mechanism (not shown) is disengaged. Referring to FIG. B, winding stylus base  281  is free to slide parallel to the suture channel  70  of the package tray  30 , guided by cam tracks  274  in the tooling base  275  after being similarly mechanically disengaged. 
     FIG.  9  and elevation view FIG. 10 illustrate the winding station power drive assembly  380 , comprised of a servo motor  381 , drive sprocket  382 , toothed drive belt  383 , and driven sprocket  384 . A vertical shaft  385  is located by appropriate bearings (not shown), fixedly mounted to the machine frame and coaxial with the rotation axis  271  of the tool nest  270  therebelow. 
     Referring now to FIG. 10, turret  250  is shown after indexing tool nest  270 , and the tray package tray  30  thereon, with a needle and suture assembly  5 , not shown, assembled thereto, into a position under the winding tooling  390 . The upper tooling assembly  391  fixed to the vertical shaft  385 , vertically slideable on splines  392  thereon, in the direction of arrow  394 , is vertically displaced downward and engaged with the lower tooling  270  therebelow. The lower surface  397  of the upper tooling  391  approaches the upper surface  279  of the lower tooling  270 , essentially damping the package tray  30  therebetween. This downward vertical displacement also causes pins  272  and  273  in the lower tooling to engage mating holes (not shown) in the upper tooling  391 , thereby causing the driven rotation of the upper tooling  391  by the belt  383  and sprocket  384  to likewise drive rotation of the lower tooling nest  270 , now torsionally integral therewith, about vertical  271 . 
     The winding stylus  290 , described hereinbelow, is similarly engaged with the stylus base  281  (See FIG.  8 ), by meshing pins and mating holes therein (not shown). The suture held down  285  (See FIG. 8) is mechanically raised, minimally to prevent suture twisting, to remove frictional drag forces on the suture  20  during the winding operation. 
     The winding stylus assembly  290 , as seen and illustrated in FIG. 11, comprises an insertion tool  410 , a flap closing tool  295 , and a mounting block  405 . The stylus insertion tool  410  has a sloping nose member  411  and a heel member  400  extending down from opposite ends of support member  406 , wherein the members  411  and  400  are separated by gap  409 . 
     Referring now to FIG. 12, the package  30  is illustrated after it has been wound but prior to withdrawal of the machine winding tooling. The illustration has a portion of the suture channel cover flaps  80  removed along the sweep of arrow  399  for visual illustration of the suture track therebeneath. Prior to the winding operation at winding station  370 , as the upper tooling  391  descends on the package  30 , a plurality of winding pins  420  are inserted into a matching plurality of holes  39  between hinged flaps  80  at the opposed curved ends  48  of the package  30 , and into the suture channel  70  prior to winding. The bundle of wound sutures  30  is accumulated on the winding pins  420  as the winding operation proceeds. The insertion of the winding pins  420  into suture channel  70  prior to the rotational winding operation displaces the bundle of strands  30  away from the package suture track inner wall  60  a distance “X”. Said suture bundle will be therefore loose after winding pin  420  withdrawal, a condition that enhances free suture dispensing by the user, particularly for relatively limp, multifilament suture material constructions. “Free suture dispensing” is a desirable package quality that refers to the ease with which the end user of the package can grasp the needle with suitable forceps and pull the entire suture length from the package, causing it to uncoil slidingly from the suture track with minimal friction. 
     Referring now to FIG. 13, the suture winding channel  70  is illustrated. The suture channel flap  80  is shown open position (i.e., displaced upwardly), pivotally raised upward by the winding stylus (not shown) about hinge point  86 . At the start of the winding cycle, the winding pins  420  are thrust in the direction of arrow  421  until contacting the floor  72  of the suture channel  70 . As the package is automatically wound it is rotatingly displaced about a vertical axis  271  as seen in FIG.  12 . The suture strand  20  trailing from the needle  10  is fed into the suture channel  70  and bears against the tapered surface  422  of winding pin  420 . Said winding pin embodies a tapered surface  422  that causes the suture strand to slide down said tapered surface, in the direction of arrow  423 , the first loop of said suture strand coming to rest generally against the suture channel floor  72 . As successive is winding loops of suture  20  are accumulated on the winding pin tapered surface  422  and slide down, an essentially linear array of loops suture  20  is formed above and in contact with the first loop of suture  20 . 
     At the completion of the winding operation, closing of the flaps  80 , and withdrawal of winding pins  420 , the array of suture loops  20  thus formed tends to position the suture strand closest to the needle  10  toward the inner wall  60  of the suture channel  70 , and the remaining loops of suture  20  sequentially outward therefrom. This resulting machine controlled arrangement of the suture loops  20  in the suture channel  70  of the package  30  enhances reliable and free dispensing of the suture  20  by the end user. 
     The illustrated process takes place on all of the winding pins  420  during the winding machine sequence. When the machine tooling  391  subsequently withdraws the winding pins  420 , the strands of suture  20  stay roughly as positioned in the suture channel  70 , but relax to form a looser cluster as seen in FIG.  14 . 
     The operation of the winding stylus  290  is illustrated in FIGS. 15,  16 , and  17 . Referring first to FIG. 15, the winding stylus assembly  290  is seen moving, during the winding operation, in the direction of arrow  291  with respect to the tray package  30 , winding a suture  20 . As winding progresses, the remaining unwound suture  20  advances in the direction of arrow  292  with respect to the stylus  290 . The suture strand  20  enters the stylus  290  and is guided by the stylus heel  400 , under little tension, and gently laid into the suture channel  70  parallel to the outer channel wall  50 , and distal to winding pins  420 . On each lap around the suture track, the stylus  290  lays an additional suture strand  20  upon the sloping surface  422  of the winding pins  420  as illustrated in FIG. 13, and described in text associated therewith. The stylus  290  is located mechanically to dear the winding pins  420  sufficiently to not pinch or otherwise impart damage to the suture strand  20 . 
     As seen in FIG. 16, the stylus  290  is illustrated sliding in the direction of arrow  291  on the suture track floor  72  with the nose  411  and heel  400  pressed with downward force of the stylus bottom surfaces  412  and  401  to bear thereon. The height H of the stylus  290  as seen in FIG. 17, is sufficient to effectively open the flaps for suture insertion, but minimized beyond that to reduce stress and potential permanent deformation of the hinges  86  of door members  80 (See FIG.  4 ). The internal height L of the stylus ceiling  406  is greater than two suture diameters above the suture track outer wall  50  thereby eliminating pinching or mechanical interference that might damage the suture  20 . 
     The heel member  400  has a suture guiding surface  402  The suture guide surface  402  is sloped backward with a positive angle B, to cause a suture strand  20  to climb upward in the direction of arrow  403  as it slides through said suture guide gap  409 , minimizing scraping of the suture against the top of the suture track outer wall  50 . 
     All surfaces of the suture stylus tool  290  are polished, free of surface irregularities, and shaped to avoid sharp edges, angles, or corners that could cause damage to the suture strands. 
     Also illustrated in FIG. 17 are stylus  290  and a door closing member  295  positioned therebehind, moving with the stylus in the direction of arrow  296 , to bear onto and press down suture channel doors  80  that do not spring back to their original closed, resting position after being raised and opened during the suture insertion operation. 
     The machine winding station  370  with sections of the drive hardware broken away to view portions of the package and stylus is seen in FIGS. 18 and 19A. The winding machine station  370  comprises a rotatable nest  270  and package tray  30  mounted therein. Said machine station further comprises a cam track  600 , rotatable therewith, said cam track having a first or inner side  601 , and a second or outer side  602 . A stylus carriage  610  has the suture guide stylus  290  and a plurality of rollers  615  engaged with the cam track  600 . Said stylus carriage is constrained by a rod  620  pivotally mounted at each end to said stylus carriage  610  and the machine frame  210  respectively. Said nest  270 , package  30 , and cam track  600  are torsionally integral and rotatably driven in the direction of arrow  291  by the motor  381 , belt  383 , pulley  384 , and shaft  385 , about the rotation axis  271 . Referring to FIG. 19A, the inner profile  601  of the cam track  600  geometrically comprises a pair of opposing straight sides  605  and a pair of opposing semi-circular ends  606 , so-configured and sized to form a surface essentially parallel to the package suture track  70 . The stylus carriage  610 , and the stylus  290  fixed thereon, moving relative to the package  30  in the direction of arrow  611 , guided by the inner rollers  615  bearing on the inner surface  601  of the cam track  600 , traces a path for the stylus  290  within the package suture track  70 . Said path is between the suture track outer wall inner surface  55  and the outer surface  422  of the winding pins  420 . Said path clears said outer wall  50  and winding pins  420  sufficiently to avoid pinching the suture  20 . The relative motion of the stylus  290  in the direction of arrow  611  causes the nose member  411  and heel member  400 , straddling the suture strand  20 , to progressively advance around the periphery of the suture channel  70 , sequentially plowing the suture channel cover flaps  80  open and threading the suture strand  20  therebelow. A trailing plow  295  (not shown) cams cover flaps  80  down afterward. 
     Referring now to FIGS. 19B and 19C, the means of generating the relative motion and controlling the path of the stylus carriage  610  relative to the package  30  is illustrated. As seen in FIG. 19B, the nest  270 , the package  30  integral thereon, and the cam track  600  are rotated in the direction of arrow  291  as described hereinabove. The stylus carriage  610  is constrained from rotating with the cam track  600  by the rod  620  and pin connection  621  thereon at the carriage end, and a similar pin connection  621  the machine frame  210 . The carriage  610  is guided by the inner track rollers  615  bearing against the inner track profile  601 . Contact of the inner rollers  615  against said inner track is assured by the backing roller  616  bearing against the outer track profile  602 . 
     FIG. 19C illustrates the mechanism of  19 B in partial angular displacement to further illustrate the cam track and stylus carriage rollers. The outer track profile  602  is sized and shaped to trace a locus of contact points  605  of the backing roller  621  as the inner rollers  615  follow the inner track profile  601 , thereby maintaining a confined but free rolling contact of the carriage  610  with respect to the track  600  passing therebetween. 
     Said locus of points will define a track width  606  that is not parallel to the inner profile  601 , but varies at the points  607  where the carriage rollers  615  and  616  transition from straight to curved sections. 
     It can be seen that the function of the inner track profile  601  is to guide the stylus  290  in the package suture channel  70 , and the function of the outer track profile  602  is to maintain proper mechanical clearance and rolling contact of the inner rollers  615 . It can also be seen that the outer and inner track functions could work equally well if reversed. 
     The winding rotation described hereinabove continues for a sufficient number of turns to insert the entire suture length  30  into the suture channel  70 , and continue additionally until the stylus  90  is at the start position illustrated in FIG.  15 . The winding tooling  390  is raised, and the turret  250  (FIG. 7) is indexed for the next operation. 
     Referring now to FIG. 20, transfer station  430  of turret  250  is seen after indexing from the winding station  370 , with the tray package  30  containing wound suture  20 . 
     The machine operations after winding take place utilizing transfers of the package  30  performed by slides and pick and place mechanisms. These devices may be actuated by air cylinders, lead screws driven by motors, servo or otherwise, and other techniques, utilizing vacuum cups or mechanical grippers to grip the product. These devices are custom designed, commercially purchased, or a combination thereof, and are known art in the machine design field. They are therefore not described in mechanical function, but by only the motion or product transfer that is made, recognizing that those knowledgeable in the design field would have a number of choices within the field of known art to accomplish the described function. 
     To complete the package assembly after winding, a cover panel  650  made of sheet material  640  is affixed thereto after first being printed with suitable label information. Said sheet material in the preferred embodiment is paper. 
     Referring to FIGS. 21 through 24, the package tray  30  is seen prior to cover  650  placement at station  430 . The needle  10  is seen contained the needle park  100  and the suture strand  20  coiled into the suture channel  70 . FIG. 24 illustrates the paper cover  650  with label information  651  printed thereon. FIG. 22 illustrates the completed package of FIG. 21 with the printed cover  650  attached thereto. The cover  650  is seen to have an outer periphery  652  shaped to conform to the package  30  outer shape, a plurality of die cut tabs  654  lanced on three sides  655 , and a printed color band  659 , which is common to the label for many suture products. FIG. 24 illustrates the paper cover  650  of FIG. 23 that has added printed information  651  unique to individual suture products, and therefore one particular production lot. This is referred to as the ‘variable information’ because it must be varied or changed often; each time the machine is set-up to package a different suture product or production lot. The function of the printer on the machine is to custom print the variable label information, from an easily changed electronic database, for each machine cycle, thereby eliminating the need to change the supply of paper covers when the machine is changed to run a different product. It can be seen that changing the supply of paper covers  650  with each machine product changeover would be required if they were conversely pre-printed off-line, resulting in waste, handling damage, mechanical feeding and hoppering complexities, consumption of time, contamination, increased inventory, and possible product mix-ups. 
     Referring now to FIGS. 25 and 26A, the paper cover supply system of the packaging machine  200  is fed with a strip  670  of pre-cut and color printed covers  650  as illustrated on the left hand side  461 . The strip  670  is indexed from left to right as indicated by arrow  671  as the machine cycles, through the printer  460 , illustrated not to scale, exiting the printer  460  on the right side  462 . The strip  670  is preferably out-sourced or manufactured in a separate high volume operation, and brought to the packaging machine in bulk roll or fan-fold stack. The strip  670  is seen to have a repeat pattern of die-cut shapes  680 . The die-cut line  682  on the periphery  652  of the cover  650  severs the cover  650  from the strip  670  except in a plurality of tie points  683 . The tie points  683  are narrow areas where the peripheral cut  682  is interrupted, and are dimensioned to be sufficiently strong to hold the cover  650  in the strip  670  during feeding, but sufficiently small in cross section to allow it to be separated and stripped out mechanically. The strip  670  is seen to additionally have a plurality of die-cut tabs  654 , positioned dimensionally to coincide with tab receiving pockets  130  (See FIG.  21 ). The strip  670  also has a printed color band  659 , and a printed bar code  656  which contains information identifying the particular printed color, thereby allowing the machine control system to read the bar code and verify the correct label color for the particular product being run. The strip  670  further comprises a plurality of pilot holes  675  dimensionally registered with the die-cut cover pattern and the printed color band and barcode. 
     Those familiar with typical commercial converting operations will recognize that the features of the cover strip  670  can be manufactured with high speed, low cost converting press operations, thereby allowing a continuous strip on a large roll or fan-fold stack to be economically supplied to the packaging machine  200 . 
     Referring now to FIG. 20, the cover strip  670  is supplied from a container  450  at the infeed area  465  of the printer  460 . FIG. 20 illustrates the cover strip  670  passing through the printer  460  in the direction of arrow  469  and emerging with printed information  651 . 
     Continuing reference to FIG. 20, the machine  200  has a printer  460  that feeds the strip  670  to print the variable information  651  as seen in FIG. 24. A number of commercial printer technologies are available for this application. The preferred embodiment utilizes a digital thermal transfer printer that accepts a downloaded digital image database for the printed graphics. The printer comprises internal feed rolls (not shown) that advance the strip  670  into the printer  460  and register the image printed thereon in dimensional registration with the paper strip pilot holes  675 . A solid optically detectible target  677 , as seen in FIG. 25, is also printed, and sensed with a suitable mounted electronic photoelectric device (not shown) to verify that the printer  460  is functioning and the image has been printed. 
     The thermal transfer printer  460  operates on the principle (not illustrated) of a print head comprising an array of micro heating elements in contact with an ink ribbon passed therebelow. The thermally activated ink transfers pixel sized dots or marks to the paper passing said print head and ribbon in accord with a digital image signal received from a PC computer suitable connected to the machine. To set up the printer  460  at the beginning of production run, an operator scans a bar code from a production form, or manually types in a code, which orders the download of the label artwork from a database electronically filed in the computer memory. A slack loop section  679  (See FIG.  20 ), in the paper strip  670  exiting the printer is maintained to allow the printer internal strip feed stroke to be non-synchronized with the winding machine mechanical feed stroke for the strip. 
     The paper strip  670  for the printing and cover placement functions described hereinabove require a precise, repeatable registration means for die cutting the cover shape, printing the variable information, and feeding to the assembly station of the machine. It also requires a cost efficient use of paper raw material, said efficiency relating to the quantity of paper consumed by the process compared to the quantity of paper covers produced. 
     FIGS. 26B and 26C illustrate conventional paper strip layouts for a commercial converting process whereby the paper strip is roll fed through the high volume rotary printing and die cutting press in the direction of arrow  690 . 
     FIG. 26B illustrates a common strip layout  700  of typical width  702  and multiple die cut covers  650  therein. The covers  650  are subsequently removed from the strip  700  and used on the packages  30 . This design is less efficient in paper use due to the relatively large scrap area  705  remaining after the covers  650  are removed, and there is no feature for subsequent accurate registration through the packaging machine printer and assembly station. The covers  650  have to be handled and automatically fed as individual pieces. FIG. 26C illustrates a strip design  710  that meets the means of registration requirements by providing sprocket holes  715  for the feeding system on the packaging machine. Further registration means is provided by a required square hole  717  configured for optical detection by the packaging machine printer. The embodiment illustrated in FIG. 26C comprises a repeating panel width  712  of two paper covers  650  each. The strip layout is less efficient due to the relatively large scrap area  718  required beyond the basic cover width  711  for the sprocket hole tracks on the strip edges  719 . 
     The preferred embodiment, illustrated in FIG. 26D, comprises a strip  720  that uses the required square printer registration holes  724  to also serve as mechanical feed holes for a linear feeder, designed to allow the holes to be on a larger pitch  726  than a sprocket feeder. Mechanical feeding is enhanced by addition of a square hole  728  on the opposing side of the strip  720 . Said square holes are off-set from the paper cover die cut shape  730  thereby requiring minimal width  732  of scrap paper. The resulting layout is efficient in paper use due to the narrow strip width  721  made possible by elimination of sprocket holes, and the more dense positioning of paper covers  650  with minimal scrap paper  736  therebetween. The strip design of  26 D includes a printed bar code  737  used to identify the printed color  738 . 
     Feeding the paper covers  650  from the printed strip  670  (See FIG. 27) illustrates the cover strip  670  comprised of printed covers  650  therein, and the separation therefrom of the printed cover  650  by the cover punch mounted therebelow, punching in an upward direction, represented by arrow  740 . The strip scrap skeleton  750 , comprised of open gaps  752  where the covers  650  were extracted, exits the machine. The cover punch represented by arrow  740  is located at the cover feed station  440  as seen in FIG.  20 . FIG. 20 further illustrates the strip s scrap bin  510  and the scrap strip  750  collected therein. Referring again to FIG. 27, the strip  670  is indexed linearly through the machine in the direction of arrow  671  by a walking beam motion device (not shown) that alternately inserts carriage mounted pilot pins  678  into the upper and lower strip registration or pilot holes  675  and advances said strip  670  one cover pitch in distance with each machine cycle. Location accuracy of printing, the die cut cover shape, and assembly vacuum gripper on the paper cover is maintained because these locations are all dimensionally registered to the same pilot holes  675 . 
     Referring now to FIG. 31, the machine turret  250 , after completion of the winding cycle described hereinabove, indexes rotationally 90° counterclockwise, thereby transporting a package tray  30  to the transfer station  430 . Said package tray  30  is in the assembly stage as seen in FIG. 2, having a needle and suture assembly  5  mounted and wound therein. 
     Continuing reference to FIG. 31, a pick-and-place device with a vacuum cup equipped pick-up head (not shown) descends upon the package tray  30 , grips, and transfers same, indicated by arrow  401 , to the cover assembly station  490  of the machine. Said pick-and-place device has a second vacuum pick-up head (not shown) positioned over the paper cover punch-out and feed station  440 . Said second vacuum pick-up head descends to said feed station  440  and vacuum grips the printed cover  650  as seen in FIG. 27, which is released from the carrier strip  670  by a stripping punch (not shown) therebeneath. Said second vacuum pick-up head elevates and linearly transfers said printed cover  650  in the direction of arrow  442 , simultaneously rotating 90° counterclockwise as indicated by rotation arrow  443 . Said second vacuum pick-up head lateral motion stops above the cover assembly station  480  and descends, depositing the cover  650  onto and aligned with the package tray  30 . 
     Referring now to FIGS. 21,  22 ,  23 , and  24 , the cover  650  seen in FIG. 24, is placed over the tray  30  seen in FIG. 21, and aligned so that the plurality of lock tabs  654  are centered over the matching lock pockets  130 . FIG. 22 illustrates the completed assembly  31  of tray  30  loaded with needle and suture assembly  5  after installation of cover  650 . 
     FIGS. 28 and 29 illustrate a plan view of the cover  650  and of the package  30  after cover assembly to form the package and cover assembly  31 . The printed information on the cover is omitted from this illustration for visual clarity. The cover  650  is attached to the tray  30  by staking a plurality of die cut paper tabs  654  into molded pockets  130  in the tray  30  utilizing the following process. Referring to FIG. 30 illustrating an enlarged section  30 — 30  of FIG.  29  through the staked paper tab  654 , a plurality of staking tools  800 , one only illustrated, positioned above each of the paper cover tabs  654 , descend downward, as indicated by arrow  801 , causing the radiused nose  802  to deform the die cut paper tab  654  into an inverted U shape, and form down into the tray pocket hole  130  until the tab end  655  has snapped past and sprung under the molded shelf  131 , thereby securing said tab  654 . The plurality of tabs  654 , latched in this manner, secure the paper cover  650  to the tray  30 . Precise function of every paper tab  654  latching under the shelf  131  is not necessary to retain the cover  650  to the package  30 . Deforming the tabs  654  into the molded holes  130  is usually adequate, although every tab  654  may not be latched. 
     Referring now to FIG. 31, after the cover  650  is installed and staked to the package in the assembly station  490 , a lateral shuttle device (not shown) transports the completed package assembly  31  as indicated by arrow  484  to the accept/reject station  520 . The package assembly  31  may be rejected and pushed in the direction of arrow  511  into the reject bin  512  if signals indicating defective assembly in the earlier operations have been detected and received by the machine electronic controller (not shown). If the package assembly  31  in the accept/reject station  520  does not have associated defects in assembly, it is transferred in the direction of arrow  516  and placed on an intermediate station or demagnetization station  530 . The package assembly  31  therein is exposed to a demagnetizing head (not shown). On the following machine cycle, a pick-and-place device (not shown) transfers the package assembly  31  in the direction of arrow  531 , simultaneously rotating same 90° clockwise as indicated by arrow  532 , lowering and loading same into the magazine hopper tray  540 . The magazine hopper tray  540  contains stacks of accepted package assemblies  31  in the magazine hopper cavities  541 . 
     The magazine hopper tray  540  is indexed linearly in the direction of arrow  542  progressively until all tray cavities  541  are filled. Filled magazine hopper trays  540  are subsequently moved in the direction of arrow  571  by the completed tray advancer  570  to a table surface of sufficient area to contain a plurality of filled magazines  540  thereon, to be off-loaded as completed product 
     Although this invention has been shown and described with respect to detailed embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail thereof may be made without departing from the spirit and scope of the claimed invention.