Abstract:
A machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, a suture package unloading arrangement and package unloading method employed in an automated machine for the high-speed individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, pertains to a suture package unloading arrangement and package unloading method employed in an automated machine for the high-speed individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures. Additionally, the automated packaging machine incorporates operative mechanism adapted to wind the sutures into a peripheral channel of the tray and facilitating the attachment of the cover to the tray which contains the single needle and attached wound suture, and which cover concurrently constitutes a product-identifying label as a component of the tray. The cover being shaped such that removal of the cover is not necessary to enable a user to gain access to the contents of the tray; in essence, the armed suture. 
     The automated packaging machine also provides for a rotary turret or dial-like turntable for the high-speed loading thereof with empty trays; the sequential loading of successive forwardly indexed trays each with a needle and attached suture; the indexed advance of the needle and suture-filled tray to suture-winding stations of the machine; the conveyance of the trays each containing the needle and attached wound suture to a cover-applying station of the machine to provide the completed suture packages, and the further advance of the suture packages for subsequent automated removal of the completed suture packages from the machine. The automated packaging machine is resultingly adapted to provide for the continuous and repetitive production of suture packages in a single high-speed production cycle without necessitating any manual manipulation thereof. 
     More specifically, in the production of suture packages as described herein, the packaging machine pursuant to the present invention provides for a workstation which includes operative robotic pivot arm structure for transferring completed suture packages from tool nests mounted on a rotary dial to compartmented trays in a continues sequence, whereby the package-filled trays may be stacked and manually removed so as to be further transported for additional processing and/or storage, and replaced by empty compartmented trays in an automated sequence. 
     The present invention is also specifically directed to the provision of a novel method for the automated unloading from the machine of completed suture packages containing the packaging individual surgical needles and attached sutures, and transferring the suture packages into compartmented trays in a continously implemented sequential operation. 
     Currently, in the medical, surgical and health-related technology, the high-speed and efficient packaging of either single or multiple sutures which are each suitably attached to surgical needles, such as by being swaged or similarly fastened thereto, and in which such combined sets of needles and sutures are generally referred to as armed sutures, is imparted an increasing degree of importance in view of the rising demand of users for such combined surgical needles and attached sutures, and various diverse types of inexpensively manufactured suture packages for the containment of needles and attached sutures have been developed and are presently widely employed. 
     In specific instances, suture packages may be covered tray-shaped containers designed to receive and fixedly retain therein one or more needles and therewith attached sutures, in which the suture packages, upon opening of the covers, must enable the uncomplicated and simple withdrawal of a respective individual needle and its attached suture in a smooth unobstructed manner. In essence, when the needle which is to be removed from the suture package is engaged by a surgeon or health professional, for example, by being gripped through the intermediary of a forceps and then pulled out of the suture tray, it is essential that the needle easily disengage from its restraint in the package while the suture which is attached to the needle should also be readily able to slip out of the tray in the absence of any binding or snagging, and in the instance of the tray housing a plurality of armed sutures also without becoming entangled with other sutures still remaining in the suture tray or package. Thus, pursuant to a specific needle and suture package construction which, for example, may comprise an injection-molded plastic tray, the needles are generally engaged by clamping structure located in the tray so as to be “parked” or retained in predetermined position or array in a central region of the tray. The sutures extending from the needles to which they are attached are then conducted under tension and wound into a peripheral channel formed within the suture tray so as to extend along the peripheral interior within length of the channel. This positioning of the needles, and particularly that of the sutures within the peripheral channel of the tray is intended to eliminate tight bends or curves normally imposed on the sutures so as to facilitate their easy withdrawal from the suture package. 
     2. Discussion of the Prior Art 
     Until relatively recently, the introduction of needles with attached sutures into suture packages or molded plastic trays was being implemented in a substantially manual manner. In that instance, the needles were manually placed into the tray so as to be clampingly engaged by means of suitable needle-gripping structure, and thereafter the attached sutures wound or positioned within the confines of the tray. Subsequently, a suitable cover was superimposed upon and fastened to the filled tray, and the resultant armed suture package conveyed to a suitable arrangement for possible sterilizing or further over wrapping. 
     The foregoing essentially manual and relatively basic process for winding the sutures into the tray, and especially the locating thereof into the peripheral channel of the tray during manipulation of the tray, was quite time-consuming, and in conjunction with the manual application of the cover into the tray in a basically individual or piece-by-piece mode, represented a serious hindrance to a large volume or mass produced manufacturing output, and adversely affected the economics in attempting to provide such large quantities of suture packages containing either single or multiple surgical needles and attached sutures. 
     As an improvement over the foregoing, there was then developed a generally semi-automated winder machine for packaging surgical needles and attached sutures in a tray-like suture package, and wherein at least some of the previously manually implemented packaging steps were to some extent automated in order to be able to increase the output of needle and suture-containing packages while simultaneously reducing the number of manual procedures in effectuating the packaging of those particular items. 
     To that effect, the semi-automated winder machine, although necessitating the manual orientation of the trays for implementing the filling thereof with needles and attached sutures, included a winding station which to a considerable degree automated the winding process for the sutures so as to place the latter into a peripheral channel extending about the circumference of the tray. Also provided was a further therewith operatively associated device which enabled covers to be manually placed on the needle and suture-filled trays to be fastened thereto by means of a pressing die forming latchingly engaging interconnections between each of the covers and the trays, while concurrently producing from a portion of the cover a product-identifying label which remains permanently attached to the tray upon subsequent detachment of the cover. Although providing a considerable advance over the state-of-the-art in the packaging of needles and sutures, the semi-automated winder machine nevertheless necessitated the implementation of a considerable number of manual and labor-intensive handling steps in effectuating the filling of the trays with surgical needles and attached sutures, attaching the cover and, generally, producing complete suture packages. 
     As a further technological advance over the foregoing semi-automated needle and suture package-forming concept, there was then developed a substantially fully automated packaging machine which is adapted, in a highly efficient and extremely rapid mode, to continually fill successive trays of the type described hereinabove with pluralities of surgical needles and attached sutures, and subsequently causing the sutures to be wound into the confines of the tray, such as into a peripheral channel extending about the tray. Thereafter, the packaging machine was designed to implement the automated positioning and fastening of covers to the needle and suture-filled trays to produce completed suture packages of the type described hereinabove, which were then adapted to be transported to a suitable locale for selective further processing, such as sterilizing, and/or over wrapping, as is required by this technology. 
     In particular, the automated packaging machine was designed to provide the packages with each housing a plurality of needles and attached sutures. For example, the packaging machine for accomplishing the foregoing, which is commonly assigned to the assignee of the present application, is described in U.S. Pat. Nos. 5,487,212; 5,473,584; 5,469,689; 5,473,810; 5,511,670; 5,452,636; 5,438,746; 5,500,991; 5,477,609; 5,485,668; and 5,487,216. 
     The flat, tray-shaped suture package produced by the packaging machine set forth in the above-mentioned patents provides for the storage therein of multiple surgical needles and attached sutures, while concurrently recognizing the need to facilitate the smooth and unobstructed withdrawal of individual needles and attached sutures from the suture package. For instance, such a suture package is disclosed in applicants&#39; U.S. Pat. No. 5,230,424, which is commonly assigned to the assignee of the present application; and wherein the suture package is referred to as an RSO package (Reduced Size Organizer). 
     In the specific design of the flat tray-shaped plastic container having a peripheral channel as disclosed in the above-mentioned patent, the suture package is basically constituted of a rectangular round-cornered and flat-bottomed injection-molded plastic tray having a flat central surface area including a raised needle clamping structure formed thereon for engaging and “parking” a plurality of needles in a predetermined spaced array. Sutures each have one end thereof attached to each of the respective needles so as to form so-called “armed sutures”. The sutures extend from each of the needles into a channel extending about the perimeter or periphery of the suture tray and are conducted into the channel so as to be essentially wound within the circumferential confines of the suture tray. The plurality of sutures which are positioned within the suture tray channel are protected against inadvertent outward displacement therefrom through the presence of a multiplicity of contiguously positioned resilient fingers which are integrally molded with the suture tray, and which project outwardly above the confines of the channel along a major portion of the length of the channel and, collectively, form a so-called “zipper structure” in which the inherently resilient nature of the fingers facilitates their temporary raising up to enable the introduction of the sutures into the suture tray channel by means of a suitable suture winding apparatus. 
     Although the rotary dial or turntable apparatus of the packaging machine pursuant to the foregoing U.S. patents provides for the packaging of armed sutures; in effect, needles with attached sutures, in a rapid and fully automated manner, such as by supplying the tray-shaped packages; thereafter parking the plurality of armed sutures in the packages, applying covers and removing the completed suture packages from the machine in a sequential station-to-station procedure, the machine was designed to primarily produce suture packages each containing a plurality of armed sutures. 
     SUMMARY OF THE INVENTION 
     Pursuant to the present inventive concept, the above-mentioned automated packaging machine is further improved upon in a novel and unique manner in that the machine is adapted to produce suture packages each containing a single armed suture, such packages being frequently in demand rather than packages containing a plurality of needles and sutures. Thus, in order to provide for high production rates which are essentially compatible with those employed in the manufacture of suture packages each containing a plurality of armed sutures, the present invention contemplates the provision of a fully automated packaging machine with a considerably increased rate of operating speed and production capability so as to render the packaging machines economically viable in comparison with the previously described automated packaging machine, while maintaining structural and functional reliability and ease of construction and maintenance. 
     In order to attain the essentially automated packaging of singly-packaged or individual surgical needles with attached sutures, the automated packaging machine pursuant to the invention sets forth the provision of a rotary turret or dial-like turntable having a plurality of tool nests each possessing a suture tray supporting surface, with each tool next being circumferentially spaced about the turntable so as to be uniformly distributed about the periphery thereof. The rotary turret is rotated to cause the tool nests supporting packaging trays to be indexed forwardly so as to advance through a plurality of successive work stations which are adapted to, respectively, effectuate the supplying of each of the trays located on the tool nests or support surfaces with a single or individual surgical needle and attached suture, winding the suture into the confines of each needle and suture-containing tray, forming a latching engagement between a tray cover and the tray; and thereafter conveying each completed suture package to a station for removal from the machine and transfer to stacking bins or the like. 
     Operatively communicating in synchronism with the indexing rotation of the rotary turret is a carousel device housing stacks of trays, which is adapted to supply empty trays sliced or separated from the bottom of a respective stack of the trays to a rotatable platform, and includes operative robotic pivot arm structure to successively remove the trays from the rotatable platform and mount the empty trays on successive tool nests so as to be oriented in a vertical plane facing radially outwardly of the rotary turret. Thereafter, each tray is indexed sequentially forwardly by the rotary turret to a workstation which will impart movement to a portion of the tool nest having the tray supported thereon, whereby the tray remains oriented essentially vertically it is rotated angularly relative to the horizontal plane of rotation of the rotary turret. This movement enables a transfer device with a needle and suture swaging mechanism processing needle grippers at a further workstation to insert and position a surgical needle with its attached suture into a therewith aligned tray for retentive engagement with needle-engaging structure formed in the tray so as to grip and park the needle therein, with the suture extending from the needle and depending downwardly therefrom outwardly of the tray. The needle and suture-containing tray is then advanced forwardly on its respective tool nest to successive workstations responsive to indexed of the rotary turret wherein, at a first suture winding station, structure operatively cooperating with the tray and the tool nest supporting the tray imparts an initial rotational movement to the tray about an axis perpendicular to the plane of the while maintaining tray the depending suture under tension, and at a second subsequent winding station imparts a rapid winding motion to the tray over multiple predetermined rotations so as to fully wind the downwardly depending suture into a peripheral tray channel extending within the perimeter of the tray. 
     Thereafter, the tool nest mounting the tray with the needle parked therein and the attached suture which has been wound into the peripheral channel of the tray is advanced to a further workstation responsive to indexed rotation of the rotary turret; at which workstation an operating mechanism causes a bottommost cover to be sliced or separated from a stack of covers and transferred to a rotatable platform. The cover is then engaged by a robotically-controlled pivot arm which, under the action of a vacuum, pivots the cover into a vertical orientation and applies the cover onto the tray while concurrently imparting pressure to the cover to cause cooperating latching structure to clampingly fasten the cover to the needle and suture-containing tray. Upon completion of the cover-attaching sequence, the resulting completed suture package is indexed to a further workstation at which suitable pivoting gripper arm mechanism engages the suture package, and the suture package is disengaged from the tool nest on which it is supported and conveyed into compartmented trays so as to be transferred to and stacked in a repository or receiving unit to be readied for further processing, such as sterilizing, overwrapping or the like, as may be required. 
     The foregoing sequence of operative steps is continually repeated for each successive tool nest on the rotary turret or turntable sequentially receiving empty trays from the carousel, while preceding tool nests each mounting a tray are conveyed through the above-mentioned packaging cycle. Thus, a successive tray is always placed into a position of readiness at a following or subsequent workstation and processed in a similar manner as before described during the forward indexing motion of the rotary turret or turntable. This ensures a continuously repetitive packaging cycle for successive suture packages in a highly efficient and high-speed operation without the need for any manual intervention in the operation of the packaging machine. 
     Intermediate various of the workstations as set forth hereinbefore; there may be arranged other workstations incorporating sensors adapted to enable ascertaining the presence of empty trays at the initial workstation, for a verification of a needle having been inserted into the trays and for inspection of the trays subsequent to the winding of the sutures into the tray channels; checking for the application of the covers to the trays, and facilitating the possible ejection of incomplete trays or the removal from the machine of defective packages. 
     A particular aspect of the invention, resides in the provision of a suture package unloading station, wherein the completed suture package which has the suture needle and attached wound suture arranged therein, and with the cover having been previously applied thereto, is unloaded from the automated packaging machine through the intermediary of pivotable robotic arm structure and deposited into suitable compartmented trays in which a plurality of superimposed completed suture packages are stacked, with the compartmented trays being indexed upon the compartments being filled, and thereafter conveyed to a stacking arrangement while being replaced by empty compartmented trays. 
     Furthermore, pursuant to another feature of the invention, in the event of ascertaining that the suture package is either incomplete or defective, the latter is not removed from the tool nest at the unloading workstation, but is permitted to advance to a subsequent workstation, and at that location removed by a grippper mechanism and deposited on a conveyor belt for conveyance to a waste disposal site. 
     Accordingly, it is an object of the present invention to provide a package unloading arrangement for removing completed suture packages from the packaging machine through the intermediary of a robotic pivot arm structure, which transfers the package into compartmented trays for further storage and/or processing of the suture packages. 
     A further object resides in the provision of novel indexing compartmented trays for the receipt of stacked quantities of suture packages in each compartment whereby filled trays are shifted to a stacking arrangement while empty compartmented trays are automatically shifted into position for the receipt of suture packages from the packaging machine in a continous operating sequence. 
     Another object of the present invention resides in the provision of a method for unloading the completed suture packages from the automated packing machine, and stacking these in compartmented trays for further storage or processing of the suture packages. 
     Still another object resides in the provision of a workstation which receives and removes rejected suture packages from the automated packaging machine, in the event that such packages are not unloaded by the package unloading arrangement, but are adapted to be advanced to this reject workstation for removing the rejected suture packages from tool nests on which they are positioned and conveying them towards a disposal site. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Reference may now be had to the following detailed description of a preferred embodiment of the invention, taken in conjunction with the accompanying drawings; in which: 
     FIG. 1 illustrates, generally diagrammatically, a plan view of the machine for the automated packaging of individual surgical needles and attached sutures, pursuant to the present invention; 
     FIG. 2 illustrates a side elevational view of the machine frame of FIG. 1; 
     FIG. 3 illustrates a top plan view of the machine frame of FIG. 2; 
     FIGS. 4,  5  and  6  illustrate, respectively, side, top plan and front end views of a tool nest utilized in the machine of FIG. 1; 
     FIG. 7 illustrates a bottom view of the dial or turntable showing the vacuum ports for supplying the tool nests of the packaging machine with a controlled vacuum; 
     FIG. 8 illustrates a vacuum plenum for imparting vacuum conditions to the tool nests of FIG. 7 during operation of the packaging machine; 
     FIG. 9 illustrates a front view of a completed suture package as produced by the packaging machine; 
     FIG. 10 illustrates a diagrammatic plan view of the suture package unloading arrangement; 
     FIG. 11 illustrates a side elevational view of the suture package unloading arrangement of FIG. 10; 
     FIG. 12 illustrates a side elevational view of the robotic pivot arm portion of the arrangement of FIG. 11; 
     FIG. 13 illustrates a top plan view of the robotic pivot arm portion of FIG. 12, shown with the pivot arm in the horizontally upward pivoted position; 
     FIG. 14 illustrates a front end view of the arrangement of FIG. 11; 
     FIG. 15 illustrates, generally diagrammatically, a side elevational view of a storage housing portion of the arrangement of FIG. 11; 
     FIG. 16 illustrates, generally diagrammatically, a fragmentary segment of the storage housing portion of FIG. 15, showing a detail of the lifting device for compartmented trays containing suture packages; 
     FIG. 17 illustrates, generally diagrammatically, a side view of an arrangement for removing rejected suture packages from the packaging machine; and 
     FIGS. 18,  19  and  20  illustrate, respectively, side, top plan and front end views in the detailed construction of the arrangement for removing the rejected suture packages from the packaging machine. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now in more specific detail to the drawings, FIGS. 1 to  3  illustrate, in a generally diagrammatic plan view, the automated needle and suture packaging machine  10  pursuant to the invention. The machine  10  comprises a rotary turret or turntable  12  which is essentially a packaging dial supported on an essentially stationary machine frame structure  14 . 
     The rigid frame structure  14 , as illustrated in FIGS. 2 and 3, basically includes structural uprights  16  and  18 , which are interconnected by horizontal beams  20 ,  22 ,  24 , with the entire frame structure  14  adapted to be supported on a floor through the intermediary of adjustable leveling footings  26 . The frame structure  14  comprises an outer stationary frame arrangement  15 , and an inner vertically adjustable frame arrangement  17  comprising horizontal beams  28 ,  30  and  32 , and vertical beams  34 ,  36  interconnected therewith supporting the turntable  12  for vertical adjustment relative to the stationary machine frame components. The vertical adjustment of the frame arrangement  17  is provided for by a central servo motor actuated jack-screw  38 , which also concurrently effectuates the vertical adjustment of all of the operative packaging devices at the various workstations of the machine so as to accommodate the packaging of a wide range of differently sized surgical needles without the necessity for modifying any machine components. Arranged within the frame structure are the various belt drives  40 ,  42 ,  44 ,  46  and  48  and operating drive components  50  for the machine, and the vacuum-generating systems  52  employed in the packaging cycles for the suture packages, as described hereinbelow. The turntable  12  is oriented in a horizontal plane, and through the intermediary of a program-controlled drive installation, is rotatable in an indexing or incrementally angular advance about a central vertical axis  54 . In this instance, during operation of the machine, the turntable  12  is rotated in a counter-clockwise direction when viewed from above, as represented by arrow A, so as to be advanced in 30° increments. 
     The rotary turret or turntable  12  is essentially constituted of a circular disk-shaped member or packaging dial which has a plurality of tool nests  60  mounted thereon. The tool nests  60  are mounted in a circumferentially uniformly spaced array on the upper surface of the package dial or rotary turret  12 , and with each tool nest  60  having an outer end projecting radially outwardly of the peripheral edge of the turret or dial  12 , as described hereinbelow. 
     In this particular construction of the packaging machine  10 , by way of example, twelve (12) tool nests  60  are arranged at uniformly distributed annular spacings of 30° from each other about the circumference of the dial or rotary turret  12 . 
     In essence, as mentioned hereinbelow, the rotary turret or turntable  12  of the packaging machine  10  is adapted to be indexed forwardly in an angularly incremental or indexed rotational advance, each such incremental advance comprising one-twelfth of the 360° circumferential rotation of the turntable, or basically 30°, along the direction of rotation identified by arrow A in FIG. 1, such that the tool nests  60  which are each adapted to mount a suture tray or package are designed to be advanced in sequence to a number of successive workstations; designated herein as workstations (1) through (12), which are stationarily evenly spaced about the periphery of the rotary turret  12 , as illustrated in FIG. 1 of the drawings. 
     The successive workstations which collectively constitute the automated machine  10  for the packaging of surgical needles and attached sutures are essentially briefly described as follows; viewed in the direction of rotation of arrow A: 
     (1) A first workstation  70  relates to the operative aspect of empty suture package trays being successively separated from the bottom of stacks of trays contained in a rotary carousel  72  to be transferred onto a rotationally indexed plate  74  under the action of a vacuum, and thereafter picked up and transferred by a cam-controlled robotic pivot arm structure  76  to successive tool nests  60  so as to be retained thereon while being conveyed by the rotary turret or dial  12  to subsequent workstations, as set forth hereinbelow. 
     (2) At this workstation  80 , to which the respective tool nest  60  supporting the empty tray thereon has been advanced by the rotational advance of the turntable  12  mounting the tool nest; in effect, indexed 30° forwardly; operative slide-controlled pivot structure  82  engages a plate element on the outer end of the tool nest  60  which supports the empty tray under a vacuum, and rotates the plate element and tray counterclockwise within the vertical plane thereof about a horizontal radial axis of the tool nest  60  through an angle of approximately sixteen and one-half (16.5°) degrees so as to be in appropriate angular orientation relative to a horizontal axis for facilitating the subsequent insertion and retention of a surgical needle and attached suture into the tray. 
     (3) This workstation  84  provides for a sensor  86  which is mounted stationarily on a bracket arrangement  88  and faces the tool nest  60  so as to be able to check for the presence of an empty tray on the tool nest. The sensor  86  is suitably aimed at a black spot present on the packaging tooling nest, and in the absence of a tray being positioned thereon, enables deactivating the forward advance of the turntable  12  and concurrently may emit a signal to alert personnel regarding the missing tray. 
     (4) The next workstation  90  along the rotational path of motion of the turntable in the direction of arrow A, provides gripper mechanism  92  for inserting a single surgical needle and a therewith attached suture into the suture tray which has been indexed forwardly by the rotary turret  12  so as to be located in operative alignment with the needle-feed mechanism. The needles are conveyed by a mechanism so as to be mounted on suitable clamping or needle “park” structure constituting an integral portion of the tray. Vacuum-controlled suture capture and tensioning devices which are located below each tool nest  60 , become operative at this workstation to capture and tension the suture portions depending outwardly and downwardly of the tray mounting the surgical needle. 
     (5) At this workstation  94 , a stationary sensor  95  located radially outwardly of the turntable  12  may be utilized to ascertain the presence of a surgical needle and attached suture having been properly introduced into the tray at the previous workstation  90 . 
     (6) A first tray winding mechanism  96  at this workstation  98  engages the plate element on the tool nest supporting the tray, while the suture capture and tensioning device ensures that the suture portion depending outwardly and downwardly from the tray is maintained under tension by a vacuum-operated tensioning device associated therewith, with the tray being rotated counterclockwise within its vertical plane through approximately 163.5°, to assume a horizontal orientation which is 180° inverse to its original orientation on the tool nest  60  at workstation (1), and with the remaining length of the suture being tensioned by the vacuum device externally of the tray. 
     (7) At a subsequent workstation  100 , a further winding mechanism  102  engages the tool nest  60  and the tray mounted thereon, and imparts rapid rotation to the tray so as to enable tray structure engaging portions of the mechanism to introduce and completely wind the entire remaining length of the suture into a peripheral groove extending about the confines of the tray. 
     (8) A stationary sensor  104  at this workstation  106  is located radially outwardly of the turntable  12 , and is adapted to ascertain the positioning of the surgical needle in the tray. 
     (9) This workstation  110  provides apparatus for the application and attachment of a cover or label to the tray containing the surgical needle and attached suture to produce or complete suture to produce a complete suture package. A rotatably indexed disc-like plate  112  includes a plurality of equidistantly circumferentially spaced cover-receiving areas, these being rotated below a vertical stack  114  of covers or labels such that, under the action of a vacuum, the bottommost covers of the stack are sequentially sliced off or separated and deposited into a respective area of the plate under the influence of the vacuum present therebeneath, and thereafter rotated into radial alignment with a tool nest  60  mounting the tray containing the surgical needle and attached wound suture. A cam-controlled robotic pivot arm structure  116  lifts the cover from the plate, while a subsequent area receives a further cover from the stack for transfer onto a following tray, and pivots upwardly and extends horizontally forwardly so as to position the cover into latching engagement with the tray, thereby forming the completed suture package. 
     (10) A robotic pivotable gripper arm  120  removes the completed package from the tool nest  60  at this subsequent workstation  122 , and swings downwardly so as to deposit the completed suture package into receiving bins or compartments within elongated tray members  124  whereby upon a certain amount of trays being deposited to fill the tray member the latter is indexed to align a further empty compartment of a tray member with the tool nests. The tray member having the various filled compartments is then conveyed to a storage unit  126  and replaced automatically by another empty tray member. 
     (11) In the event of a suture package being defective, such as having a cover lacking or misplaced, and the resultant package has accordingly not been removed at the preceding package unloading workstation  122 ; at this workstation  130  a reciprocating arm structure  132  has a gripper head which engages and removes the rejected packages from the tool nests, and deposits them onto a conveyor belt  134  for conveyance to a suitable waste disposal site. 
     (12) A sensor  77  at the final workstation on the packaging machine  10  checks for the presence of a package that may not have been removed at stations (10) and (11). This is a further safegard built into the packaging machine to ensure that the tool nest at station (1) is empty and ready to accept an empty package tray. 
     As shown in FIGS. 4 through 6, each tool nest  60  includes a housing  140  which is fixedly mounted on the upper surface  142  of the rotary turret  12 . Each housing  142  includes a horizontal radially extending central through bore having a shaft  144  rotatably journaled therein. The shaft  144  is normally secured against rotation within housing  140 ; however, at predetermined workstations of the machine, the shaft  144  may be released by means of a locating pin  141  so as to be axially radially inwardly movable within housing  140  against stationary cam structure  143  mounted centrally on the rotary turret or dial  12  for regulating the rotational displacement which may be imparted to the shaft  144 , as discussed hereinbelow in more specific detail. 
     The radially outwardly facing structure  148  of a plate element  150 , which is fixedly secured to the radially outer end of shaft  144 , is adapted for supporting suture package components, and particularly the package trays which are utilized in the production of surgical needle and attached suture-containing packages. 
     In essence, the radially outer structure of the tool nest housing  140  for mounting suture trays includes the plate element  150  which comprises an elongate vertically oriented plate member  152  having generally parallel opposite sides  154  and convexly rounded opposite ends  156  so as to be generally in conformance with the peripheral shape of a package tray. An external planar surface on the plate member  152  includes protruding perimeter or rim structure  158   5  for seating engagement therein of a suture tray, with the plate member  152  being fixedly secured to the radially outer end of the shaft  144  so as to be adapted for rotation therewith. Extending forwardly from the external planar surface of the rotatable plate member  152  of the tool nest  60  are protuberances or guide pins  160  which are intended to align the package tray thereon for appropriate positioning on the plate member  152 , with the tray adapted to be retained thereon through the application of a vacuum to the exterior plate member surface through passageways communicating with a vacuum source connected thereto through the tool nest housing  140 . 
     The vacuum passageways extend through the lower surface  162  of the dial or turntable  12 , as shown in FIG. 7, which includes a plurality of apertures  164  each communicating with, respectively, passageways leading to an associated tool nest  60 . The vacuum is supplied to the apertures  164  in a selective controlled mode through the intermediary of a stationary vacuum plenum  166  arranged below the dial  12 , as shown in FIG. 2 of the drawings. The plenum  166 , as shown in FIG. 8, includes outlet slots  168  and ports  169  for applying or closing a vacuum to respective tool nests  60  in accordance with the rotational positions of the dial  12  with the aperture or ports  164  in the lower surface  162  being in communication with the vacuum plenum outlet slots or ports. 
     The suture package tray  170 , as shown in FIG. 9 of the drawings, is essentially constituted of molded plastic material, and includes a planar base  172  with parallel sides and semi-circular rounded ends. A vertical wall  174  extends about the perimeter of the tray, while inwardly spaced thereof is a second vertical wall  176  having radially outwardly extending fingers  178  which are flexible at the upper edge reaching close to the outer wall  174  so as to define a hollow channel structure. Apertures and surgical needle engaging structure is molded into the tray, as more specifically disclosed in copending U.S. patent application Ser. No. 08/521,978; filed Aug. 31, 1995 (Attorney Docket ETH-1088; D-9570), the disclosure of which is incorporated herein by reference, and which is commonly assigned to the assignee of this application. 
     The packaging tray  170  is shown with the cover  180  having been applied thereto so as to produce a complete suture package  182  having a single needle and attached suture arranged therein. The cover  180  extends over only a portion of the packaging tray area so as to afford visual inspection of the contents of the suture package. Interengageable latching structure  184 , such as cut-outs and flaps, formed on the cover and package tray ensure their latched engagement upon application of the cover  180  to the packaging tray  170 . The cover surface  186  may be provided with suitable printing whereby the cover, in essence, also constitutes a label for the suture package. 
     Reverting now more specifically to the description of the suture package unloading workstation  122  (10), reference may be had to drawing FIGS. 10 through 16. Basically, the components of the workstation  122  are supported on a stationary horizontal platform  190 . The major components, as detailed hereinbelow are a robotic arm arrangement  192 ; elongate parallel movable racks comprising compartmented trays  194  each possessing a plurality of compartments  196 , which are adapted to each receive and stack a predetermined quantity of completed suture packages  182  which have been removed in succession by means of the robotic arm arrangement  192  from tool nests  60  on the turntable  12  of the packaging machine  10 . 
     The compartmented trays  194  are each mounted so as to be slidable along parallel supports  200 ,  202  radially extending into proximity with and below the turntable  12  of the packaging machine. 
     As can be ascertained from the drawing FIGS. 10 and 11, each compartmented tray  194  is movable along its longitudinal axis by means of tray-engaging elements  204  spaced along the bottom of each of the supports  200 ,  202 . The slidable support  200  is adapted to convey empty of the compartmented trays  194  towards the turntable  12 . The slidable support  202 , conversely, is adapted to index compartmented trays beneath the robotic arm arrangement  192  for filling the compartments  196  with stacks of suture packages and then conveying the suture package-filled compartmented trays away from the turntable  12  for stacking in a storage  208  through the intermediary of an elevator mechanism  214 . As shown in FIG. 14, the longitudinal or axial conveyance of slidable support  200  is implemented by a drive unit  212 , whereas the indexing motion and conveyance of slidable support  202  is carried out through an indexing and drive unit (not shown) which is located below the platform  190 . 
     Referring more specifically to FIGS. 11 through 14, the robotic arm arrangement  192  is located above the slidable support  202  and includes a housing  220  straddling the support  202 , with the housing being arranged intermediate the compartmented tray storage  208  and the turntable  12  of the packaging machine  10 , in effect along the path of axial movement or travel of the compartmented trays  194  which are being filled with suture packages  182  and transported to the storage  208 . 
     In essence, a continuous sequence of empty compartmented trays  194  are adapted to be advanced forwardly along a path of travel towards turntable  12  (not shown) as shown by arrow A in FIG. 10 so that a forwardmost compartmented tray is in position adjacent a pusher plate  200  of drive mechanism  222  for displacing the forwardmost compartmented tray  194  laterally in the direction of arrow B. When a compartmented tray  194  has its most rearward compartment  224  located in alignment with the robotic pivot arm arrangement  192 , the compartment is successively supplied with a predetermined quantity of suture packages  182 ; i.e. such as ten (10) packages. At that point, the compartmented tray is indexed in the direction of arrow C by a distance of one compartment  224  so as to enable the following compartment to be filled with suture packages  182 . This sequence is repeated until all of the compartments have been filled with suture packages, whereupon the filled compartmented tray is advanced towards the storage  208 , as described hereinbelow. At that time, the forwardmost compartmented tray  194  on the slidable support  200  is laterally displaced by the pusher plate  220  which slides along support rods  230 ,  232  adjacent a piston unit  234  of the drive mechanism  222  so as to locate the rearwardmost compartment  224  thereof below the robotic pivot arm arrangement  192 . Thereupon, the filing cycle for the compartmented tray  194  is repeated as heretofore, while a successive empty compartmented tray  194  is advanced forwardly along arrow A so as to positioned adjacent the retracted pusher plate  200 . 
     Reverting to the construction of the robotic pivot arm arrangement  192 , the housing  220  incorporates driving mechanism (not shown) located in housing portion  240  having a depending arm  242  with a pivotable arm device  244  for conveying suture packages  182  from therewith aligned tool nests  60  (not shown) into the compartments  224  of the compartmented trays  194 . 
     The robotic pivot arm arrangement  192  has pivot arm device hinged for swinging and axial movements at hinge point  246  so as to be oriented downwardly, as shown in FIGS. 11 and 12 for depositing suture packages  182  into the compartments of the compartmented trays  194 , or extended horizontally for reciprocation, as shown in FIG.  13 . During that horizontally oriented axial reciprocatory movement, the pivot arm device is adapted to remove suture trays  182  from the plate element  150  on a therewith aligned tool nest  60 . The free or distal end  250  of the pivot arm device  244  includes a gripper attachment  252 . Upon a suture package  182  being arranged on the tool nest  60  which is located at this workstation of the turntable  12 , the arm  254  is horizontally oriented and extended towards the tool nest  60  so as to have the gripper attachment  252  contact the suture package  182 . While the vacuum retaining the suture package  182  on the tool nest  60  is concurrently released, the suture package  182  is withdrawn from the tool nest  60  by the pivot arm  254 . 
     The pivot arm  254 , with the suture package  182  adhering to the gripper attachment  282  is then retracted and pivoted downwardly, as shown in FIGS. 11 and 12, whereupon the gripper is released so as to enable the suture package  182  to drop into a compartment  224  located therebeneath. The turntable  12  is concurrently indexed forwardly, as shown in FIG. 1, so as to permit a successive tool nest  60  mounting a completed suture package  182  to be positioned at the package unloading workstation, and the pivot arm  254 , which has already released the previous suture package  182  is swung upwardly into its horizontal position and extended forwardly so as to contact the suture package  182  located on that tool nest  60 , and the gripper  252  while the vacuum in tool nest  60  is released as heretofore. Then, as previously, the pivot arm is retracted, swung downwardly and the gripper  252  released so as to enable the suture package  182  to drop into the compartment  224  therebelow in superposition on the previous suture package or, alternatively, if the compartment is full and the compartmented tray  194  has been indexed forwardly by one compartment in the direction indicated by arrow B in FIG. 10, to cause the suture package to drop into an empty compartment. 
     Referring more specifically to FIGS. 10 through 15, the filled compartmented trays  194  each of which; for example, may have a series of eight compartments  224  each having ten suture packages  182  stacked therein, are successively conveyed by slidable support  202  to a position below the storage  208 . The storage  208  consists of an open housing structure  258  having two adjacently arranged vertically-extending chutes  260 ,  262 , one of which is adapted to have empty compartmented trays  194  stacked therein, and the other receives filled compartmented trays  194 . The housing structure  258  has a lifting arrangement  260  connected therewith, which may be a pneumatic cylinder  212 , as shown in FIG. 14, which raises the compartmented trays  194  in sequence, as diagrammatically illustrated in FIGS. 15 and 16. In that instance, pivotable fingers  266  which swing about pivot points  268  under the biasing action of tension springs  270 , and which are connected to slidable frame elements  272  operated by a lift or hoisting drive  274 , raise the filled compartmented trays  194  so as to facilitate further trays to be positioned therebelow. The stacks of filled compartmented trays  194  may then be manually removed from the open side  276  of housing structure  258 ; in effect, from chute  262 , and empty trays  192  inserted into adjacent chute  260  so as to be lowered onto slidable support  200 . 
     In the event that it has been previously ascertained; for example, through suitable sensor means or the like, that a suture package  182  located on a tool nest  60  is either incomplete or defective; rather than the suture package being removed at the unloading workstation, the defective suture package  182  is allowed to be advanced on its tool nest  60  by the turntable  12  to a subsequent reject workstation  130  (11), at which a reject arrangement  132  is adapted to remove the defective or incomplete suture package  182  from the packaging machine  10 , referring to FIGS. 17 through 20 of the drawings. 
     The arrangement  132  for removing defective suture packages  182  comprises a conveyor belt  290  supported on a stationary frame structure  292  having a base plate  294 . The conveyor belt  290  is connected to a belt drive  296  operated by a driving motor  298  which imparts a continuous motion to the conveyor belt so that the upper run  300  thereof travels in the direction of the arrow; in effect, radially outwardly away from turntable  12  and tool nest  60  mounting a rejected suture package  182  on plate element  150 . 
     Located above the conveyor belt  290  is an axially slidable member  310  which is reciprocable towards and away from the suture package  182  responsive to the pivoting action of a pivot arm  312  connected thereto at pivot point  314 . A vertical shaft  314  has the upper end  316  connected to the pivot arm  312  and at its lower end  318  is connected to a drive unit  320  for imparting oscillatory rotational movement thereto. 
     At the forward end  322  of slidable member  310 , there is connected a head portion  324  having elements  326  adapted to engage the suture package  182  in the forwardly advance position of slidable member  310 . Upon engaging the suture package  182 , the vacuum in the tool nest  60  is released, thereby enabling the elements  326  to grasp the package  182 , the slidable member  310  to retract by means of the pivoting of shaft  314  to swing pivot arm  312  backwards. The elements  326  on head portion  324  then release the suture package  182  so that the latter drops onto the upper run  300  of the conveyor belt  290  so as to be conveyed towards a waste disposal location. The foregoing operation is continually repeated for each tool nest  60  coming into alignment with workstation  130 , even if no suture package  180  is located at that workstation, so as to ensure that any suture package will be prevented from passing this workstation, and thereby the machine will always be ready to continue in successive complete packaging sequence or cycle for producing suture packages. 
     While there has been shown and described what are considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit of the invention. It is, therefore, intended that the invention be not limited to the exact form and detail herein shown and described, nor to anything less than the whole of the invention herein disclosed as hereinafter claimed.