Needle-suture assembly and packaging system

An automated machine for attaching a suture to a surgical needle having a suture receiving opening formed therein, and for packaging the same in a package tray comprises a first workstation including a device for sorting a plurality of needles and orienting each needle for automatic feeding to a second swaging workstation, a second workstation including a device for automatically cutting an indefinite length of suture material to a definite length and a device for automatically swaging the needle to close the suture receiving opening about a free end of the suture to secure the suture thereto and form a needle-suture assembly, a needle packaging station including a device for sequentially receiving at least one of the needle-suture assemblies in a package tray in synchronism with the second workstation, the needle packaging station having a device for automatically winding the depending suture portion of the needle-suture assembly into the package tray, a first indexing device for sequentially receiving individual oriented needles fed from the first workstation and transferring each of the needles from the first workstation to the second workstation to form the needle-suture assembly thereat, the first indexing device sequentially indexing the needle-suture assemblies from the second workstation to the needle packaging station.

FIELD OF THE INVENTION 
The present invention relates generally to machines for producing armed 
surgical needles, i.e., surgical needles having a suture strand of 
predetermined length attached at one end thereof, and machines for 
packaging the same, and more specifically to a high-speed needle-suture 
assembly and packaging system that automatically assembles armed surgical 
needles and packages them in a organized package of unique construction. 
DESCRIPTION OF THE PRIOR ART 
Presently, armed surgical needles used by surgeons and medical personnel 
are manufactured utilizing manual and semi-automated procedures such as 
those described in U.S. Pat. Nos. 3,611,551, 3,980,177, and 4,922,904. For 
instance, as described in U.S. Pat. No. 3,611,551, manual intervention is 
required by an operator to accurately position a suture tip within a 
suture receiving opening of a surgical needle to accomplish swaging 
thereof. This process is costly in terms of man-hour labor and efficiency 
because of the manual manipulations involved. 
Indefinite length of suture material may be supplied wound on a bobbin, or, 
a king or driven spool before being cut and positioned within the swaging 
end of a surgical needle. In U.S. Pat. No. 3,980,177 the suture material 
is fed from a spool and taken up on a rotating tension rack where uniform 
length strands are subsequently cut. Thus, the length of the suture is 
determined by the size of the rack and manual intervention is required to 
prepare the rack for the cutting of the suture material wound thereabout. 
Moreover, manual intervention is required to change the rack each time a 
suture strand of different length is desired. 
In U.S. Pat. No. 4,922,904, the suture material is supplied wound on a 
bobbin and is fed through various guide means prior to insertion within 
the suture receiving end of the surgical needle. In one embodiment shown 
therein, an elaborate television monitoring means is required for aligning 
the drawn suture within the suture receiving opening of the surgical 
needle prior to swaging thereof. In the same embodiment, a rotary encoder 
device is used to determine the length of suture material unwound from the 
bobbin prior to cutting. In an alternative embodiment, after swaging of 
the indefinite length of suture material to the needle, the needle-suture 
assembly is additionally fed a predetermined distance prior to cutting to 
obtain a suture strand of predetermined length. Thus, to obtain uniform 
lengths of suture material every time requires careful manipulations and 
precise controls, and the processes used to accomplish these tasks are 
slow and inefficient. 
Additionally, at the present time, the introduction of needles with 
attached sutures into suture packages or molded plastic trays is being 
implemented in a substantially manual manner. In that instance, the 
needles are manually placed into the tray so as to be clampingly engaged 
by means of suitable needle-gripping structure, and thereafter the 
attached sutures are wound or positioned within the confines of the tray. 
Subsequently, a suitable cover is superimposed upon and fastened to the 
filled tray, and the resultant suture package conveyed to a suitable 
arrangement for possible sterilizing or further overwrapping. 
The foregoing essentially manual and relatively basic process for winding 
the sutures into the tray, and especially the locating thereof into a 
peripheral channel of the tray during manipulation of the tray, is 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, 
represents a serious hindrance to a high volume mass produced 
manufacturing output, and adversely affects the economics in attempting to 
provide such large quantities of suture packages containing multiple 
surgical needles and attached sutures. 
In view of the limitations of the devices described in the aforementioned 
patents, it would be desirable to provide a needle-suture assembly and 
packaging system that is fully automated and which can automatically 
prepare surgical needles having uniform lengths of suture material 
attached thereto. 
Furthermore, it would be desirable to provide a needle-suture assembly and 
packaging system facilitating the automated high-speed packaging of 
surgical needles having sutures attached thereto. 
Furthermore, it would be highly desirable to provide an automatic 
high-speed needle threading and swaging system and automatic high-speed 
packaging system that is computer controlled and that can provide 
automatic adjustments to the swage tooling dies when different size 
sutures are swaged to correspondingly sized surgical needles. 
SUMMARY OF THE INVENTION 
Accordingly, it is an object of the present invention to provide an 
automatic needle-suture assembly and packaging machine for producing and 
packaging armed surgical needles in a package of unique construction and, 
packaging the same that is operable under the control of a control system 
computer. 
It is another object of the instant invention to provide a cost-effective 
automatic needle-suture assembly and packaging machine that virtually 
eliminates operator exposure to any repetitive manual operations. 
It is still another object of the instant invention to provide an automatic 
needle-suture assembly and packaging machine that incorporates a rotatable 
swage dial having a plurality of multi-axis grippers that automatically 
grip surgical needles for indexing to a plurality of processing stations 
that include: a loading station for transferring individual precisely 
oriented surgical needles from a conveyor to the multi-axis grippers; a 
swaging station that automatically draws an indefinite length strand of 
suture material, cuts the strand, inserts the free end of the definite 
length strand within the suture receiving end of the needle, and swages 
the suture strand to the surgical needle; a pull-test station that 
automatically performs minimum and n-count destructive pull-testing of the 
needle-suture combination; and finally, a needle-suture load to package 
station where armed, pull-tested needles are transferred to the automatic 
packaging station for packaging thereof. 
Yet another object of the present invention is to provide an automatic 
needle-suture assembly and packaging machine that incorporates a rotatable 
suture winding and packaging dial having a plurality tool nests, each for 
supporting a package tray for indexing to a plurality of workstations that 
include: a package load station for loading an empty package tray onto a 
supporting structure of the tool nest; a package detect station for 
detecting the presence of an empty package tray; a needle-suture load to 
package station where armed needles are transferred to the package from 
the rotary swage dial; a needle check station where the presence or 
absence of the armed needles is checked; a winding station where the 
sutures that depend from each surgical needle are gathered to a bundle and 
wound around a peripheral channel located about the periphery of the 
package tray; a cover loading station where a cover is applied to the 
package; and finally, a package removal station where the completed 
package is removed from the machine, or rejected if the package is flawed. 
Yet still another object of the present invention to provide a high-speed 
automatic needle-suture assembly and packaging machine that is operable 
under the control of a control system computer and can provide continuous 
on-line tool adjustments without unnecessary interruptions and without 
manual intervention. 
These and other objects of the present invention are attained with an 
automated machine for attaching a suture to a surgical needle having a 
suture receiving opening formed therein, and for packaging the same in a 
package tray, the automated machine comprising: a first workstation 
including means for sorting a plurality of needles and orienting each 
needle for automatic feeding to a subsequent workstation; a second 
workstation including means for automatically cutting an indefinite length 
of suture material to a definite length suture strand and means for 
automatically swaging the needle to close the suture receiving opening 
about a free end of the suture to secure the suture thereto and form a 
needle and suture assembly; a needle packaging station including means for 
sequentially receiving at least one of the needle-suture assemblies in a 
package tray in synchronism with the second workstation, the needle 
packaging station having a means for automatically winding the suture into 
the package tray; a first indexing means for sequentially receiving 
individual oriented needles fed from the first workstation and 
transferring each of said needles from the first workstation to the second 
workstation to form the needle-suture assembly thereat, the first indexing 
means sequentially indexing the needle-suture assemblies from the second 
workstation to the needle packaging station, whereby unsorted needles and 
an indefinite length of suture material are automatically formed into a 
plurality of oriented needle and suture assemblies and positioned within 
the package to facilitate their orderly removal therefrom.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
Generally, as shown in the conceptual plan view of the needle threading and 
swaging system and needle-suture packaging system of FIG. 1, parallel 
operations take place simultaneously at four (4) different workstations 
positioned about a rotary swage dial 150 to ensure a high rate of 
production of surgical needles having sutures attached thereto. 
Additionally, parallel operations take place simultaneously at eight (8) 
different workstations positioned about the larger suture winding and 
packaging turret 500 where the armed surgical needles are automatically 
parked into a reduced size organizer package of unique construction. FIG. 
2 illustrates a typical surgical needle 9 having a suture receiving 
opening or end 7 for swaging a suture strand thereto, and an arcuate blade 
portion 8. 
The automatic needle threading and swaging portion of the invention shown 
in FIG. 1 includes four workstations located about the periphery of the 
rotary swage dial 150 that are successively utilized to form needle-suture 
assemblies. These workstations include: a needle sorting station 100 that 
sorts, singulates, and conveys precisely oriented surgical needles to a 
plurality of retractable (multi-axis) grippers mounted on the rotary swage 
dial 150. The rotary swage dial 150 successively rotates counter-clockwise 
as shown by arrow "A" in FIG. 1, to index each needle to the automatic 
swaging station 200 where the suture material inserted into the needle, 
cut, and automatically swaged thereto. Next, the rotary swage dial 150 
rotates further to index the armed needle to the automatic pull-test 
station 300 where each armed needle is pull-tested to ensure that minimum 
and/or destructive pull-test requirements are met. Then, the rotary swage 
dial 150 indexes the pull-tested armed needle to a discharge station 600 
where the armed surgical needles are handed off to a package tray of 
unique construction at the rotary suture winding and packaging turret 500 
for automatic packaging thereof. Hereinafter, the discharge station 600 
will be referred to as the needle-suture load to package station. 
Generally, the automatic packaging portion of the invention shown in FIG. 
1, includes eight (8) workstations located about the periphery of the 
rotary suture wind and packaging dial 510 that are successively utilized 
to form the completed package of surgical needles. These stations include: 
a package load station 400 for successively feeding an empty package onto 
a support plate of a tool nest mounted on the packaging dial; an optional 
package detect station 450 for checking the presence of the loaded empty 
package; the needle-suture load to package station 600; an optional needle 
check station 475 for detecting missing needles; a suture winding station 
550 where the trailing sutures of the armed needles are gathered and wound 
into the package; an optional manual inspection station 625; a paper 
insert station 650 where a paper cover is applied to the package; and, a 
package removal station 700 where the completed package is removed from 
the machine for further processing, or, if the package has been found 
defective during inspection, is scrapped. 
All of the processes performed by the needle-suture assembly and packaging 
system of the instant invention are under control of a control system 
computer 99 as shown in FIG. 1. Alternatively, the control system may be 
implemented in a plurality of programmable logic controllers or other such 
suitable control devices (not shown). 
To begin, the control system 99 initiates power up of the various devices 
utilized in the automatic needle-suture assembly and packaging system. At 
this point, an operator may be prompted to set up the dies for the swaging 
assembly that correspond to the size of the batch of needles to be 
processed. Additionally, any other necessary adjustments and setups may be 
performed for each assembly, for e.g., to initialize the Adept.RTM. robot 
assembly at the needle sorting station 100, or, the needle supporting 
blade of the load cell in the automatic pull-test station 300. Also as 
part of the power up display, an operator may be prompted to choose 
between operating the system in the normal, fully automatic mode, or, in a 
single step mode for diagnostic and trouble-shooting purposes. 
FIGS. 3(a)-3(d) are block diagrams generally illustrating the automatic 
needle-suture assembly and packaging system 10 of the instant invention. 
For instance, at the needle sorting apparatus 100, needles are first 
loaded into a vibratory bowl at step 11, automatically sorted and linearly 
fed at step 12 to a translucent indexing conveyor at step 13, evaluated 
with respect to orientation and position by a vision tracking system at 
step 14, picked up by a robot apparatus at step 15, transferred to a 
precision conveyor by the robot apparatus at step 16, and finally conveyed 
to a load station where the needles are transferred to a multi-axis 
gripper located on a rotary swage dial 150 for subsequent transfer to the 
swaging station 200 indicated at step 17. A detailed explanation of the 
apparatus used to carry out each step will be explained in further detail 
hereinbelow. 
Simultaneous with the needle sorting process described above with respect 
to steps 11 through 17, an automatic suture cutting and swaging process is 
taking place at the swaging station 200 shown in FIGS. 3(a) and 3(b) with 
respect to steps 19 through 30. Indefinite length suture material is 
supplied in various spools and configurations that may carry up to 5000 
yards of material. This is indicated at step 19 in FIG. 3(a). Next, at 
step 20, the suture material is loaded into a payoff assembly which is 
part of a drawing tower apparatus to be described in detail below. This 
payoff assembly includes grippers that alternately draw the suture 
material from the spool to enable cutting thereof. When larger spools of 
material are used, the material may be optionally loaded in a driven spool 
feed assembly with a dancer as indicated at optional step 21 to ensure 
that the material does not break or snap when in tension. 
While the material is being drawn, it may require extra treatment or 
processing. For instance, as described in detail below, it may be 
desirable to heat the suture material under tension at the suture tip in 
order to stiffen the material to facilitate the positioning thereof within 
the suture receiving opening of a surgical needle. Thus, at optional step 
22, heat may be applied to a portion of suture material. At step 23 of the 
block diagram of FIG. 3(a), the suture material is gripped by the servo 
grippers. At step 24, the suture strand is drawn up the tower and 
positioned for insertion within the suture receiving opening of the needle 
for swaging. 
After a surgical needle is indexed to the swaging station 200 as described 
above, the multi-axis gripper positions the needle in a precisely oriented 
position at the swage die opening formed at the ends of two swaging dies 
of a swage assembly as indicated as step 26 in FIG. 3(b). Simultaneously, 
the suture strand is drawn from a king spool along a single axis of a 
drawing tower to register a tip thereof for insertion within the suture 
receiving end of the needle. Next, at step 27, the gripper assembly at the 
drawing tower inserts the tip of the suture strand within a lower funnel 
guide for accurate positioning within the suture receiving opening of the 
needle that is aligned with the suture drawing axis. Then, at step 28, the 
multi-axis gripper releases its grip on the needle placed within the swage 
die opening. At step 29, the swage cylinder is activated to automatically 
swage the suture to the needle and to cut the indefinite length of suture 
strand at a predetermined length. While retaining the armed needle, the 
multi-axis gripper is then retracted at its station on the rotary swage 
dial as shown as step 30 and indexed to a pull-test station 300 at step 31 
so that minimum pull-testing at step 32 or destructive pull-testing at 
step 33 may be performed. 
Depending upon the results of the minimum pull-test, the armed needle will 
either be indexed by the rotary swage dial to the discharge station 400 
where the armed needle will be discharged to the suture winding and 
packaging turret 500 if the pull-test requirements are met (as shown as 
step 34a in FIG. 3(b)), or, will be discharged at the pull-test station if 
the needle fails the minimum pull-test (as shown as step 34b in FIG. 
3(b)). The destructive pull-test always renders the armed needle incapable 
of further processing so the needle is automatically discharged at the 
pull-test station 400 as indicated at step 35 in FIG. 3(b). 
As indicated in FIG. 3(c), while the needle-suture assembly processes are 
being performed at the rotary swage dial, the automatic packaging 
processes are taking place about the suture wind and packaging turret 500. 
As indicated as step 40 in FIG. 3(c), at the package load station 400, an 
empty package tray is positioned on a tool nest located on the rotary 
suture winding turret 500. At step 43, the empty package tray is indexed 
to an optional package detect station 450 for checking the presence of the 
loaded empty package. Next, at step 45, the empty package tray is indexed 
to the needle-suture load to package station 600. As will be explained in 
detail below, the empty package tray support is engageable with an 
elevator assembly that successively registers the package tray for 
sequential receipt of needles from the rotary swage dial, as indicated at 
step 51. Then, as shown as step 55 in FIG. 3(c), armed needles that have 
passed the minimum pull-test are conveyed to a needle-suture load to 
package station 600 where up to eight individual armed needles are loaded 
into the package. As shown as step 58 in FIG. 3(c), the package tray 
containing the armed needles are indexed to the optional needle check 
station 75 for detecting missing needles. The next few steps take place at 
the suture winding station 550 where the suture strands depending from the 
needles are first gathered into a bundle by a vacuum assembly as shown as 
step 61 in FIG. 3(d). Then, the package tray containing the armed needles 
is oriented at step 64 to facilitate cooperative engagement with the 
winding stylus at step 67 that is extended to position the gathered suture 
bundle within the peripheral channel of the package tray. Next, at step 
70, the package tray is rotated so the gathered suture bundle is wound 
around the peripheral channel. Finally, at step 73, the package tray 
containing armed needles is indexed to an open station 625 which may be an 
optional manual inspection station. At the same time the package is 
indexed to the open station, a package cover (lid) is loaded onto a 
gripping device, as shown at step 77, for attachment to the package tray 
at the paper insert station 650. At step 80, the package tray is indexed 
to the paper insert station 650 where the gripping device places the 
package cover onto the package tray to form a completed package. Finally, 
as indicated at step 83 in FIG. 3(e), the completed package is indexed to 
the package removal station 700 where the package is either discharged for 
further processing, as shown in step 87, or, if the package is determined 
to be flawed, is discharged to a reject bin as shown at step 89. 
Needle Sorting Station 
The needle sorting station 100 sorts, singulates, and successively conveys 
individual and precisely oriented surgical needles to each of four 
multi-axis grippers indexed thereat by the rotary swage dial assembly 150, 
in the following manner: 
At the needle sorting station 100 illustrated in FIG. 4, a batch of 
unoriented needles of uniform size are first loaded into vibratory bowls 
101a,b, automatically sorted and linearly fed by singulating devices 
102a,b to each of two translucent indexing conveyors 105a,b, evaluated 
with respect to orientation and position by a vision tracking system (not 
shown), picked up by either of two robotic apparatuses 106a,b, transferred 
to individual engagement devices (boats) 108 located on a precision 
conveyor 107 by each robot apparatus, and finally conveyed to the rotary 
swage dial assembly where the needles are transferred to a multi-axis 
gripper for subsequent transfer to the swaging station 200 as will be 
described in further detail below. A detailed explanation of the needle 
sorting apparatus 100 is explained in further detail in copending U.S. 
patent application Ser. No. 08/181,600, and a detailed explanation of the 
robotic control system utilized therein is described in copending U.S. 
patent application Ser. No. 08/181,624 both of which are assigned to the 
same assignee as the present invention, and incorporated by reference 
herein. 
Rotary Swage Dial/Multi-axis Gripper 
As indicated at step 17 in FIG. 3(a), the next step of the needle threading 
and swaging process 10 involves the loading of the individual precisely 
oriented surgical needle 9 from the precision conveyor boat 108 onto the 
multi-axis gripper 155. At this point, the precision conveyor boat 108 is 
in a vertical position on conveyor 107 and carrying needle 9 in a precise 
orientation as shown in FIG. 5. As shown in FIG. 5, the needle 9 is 
delivered from the engagement jaws 111,112 of the conveyor boat 108 to the 
multi-axis gripper 155 that has been indexed to the needle sorting station 
100 in opposed relation with the precision conveyor boat 108. 
In the frontal view of the multi-axis gripper 155 as shown in FIG. 10(a), 
there is shown gripper pin assembly 152 comprising pins 142, 146, and 148 
that extend perpendicularly therefrom to engage needle 9. Generally, to 
accomplish the transfer of the needle to a multi-axis gripper, the 
multi-axis gripper is extended from its retracted position upon the swage 
dial assembly 150 in the manner described below, so that pins 146 and 148 
of the gripper pin assembly penetrate a plane formed by the curvature of 
needle 9 positioned upon the precision conveyor boat 108 as shown in FIG. 
5. Then, the control system 99 initiates the command for a load solenoid 
or similar device to open engagement jaws 111,112 of the precision 
conveyor boat 108 to release the needle 9 so that it is deposited between 
the pins 146 and 148 of the multi-axis gripper 155. A front view of the 
multi-axis gripper 155 with needle 9 positioned thereon after transfer 
from the precision conveyor boat 108 is illustrated in FIG. 10(a). After 
the transfer, as controlled by the control system computer, pin 142 is 
actuated from a non-engaging position to an engaging position to thereby 
engage the needle 9 in an oriented position as shown in FIG. 10(b). The 
multi-axis gripper 155 is then retracted from its extended position and 
the swage dial assembly 150 is rotated to the swaging station 200 for 
automatic swaging of the suture to the needle 9. 
FIG. 10(b) illustrates pins 142 and 144 located along the outer arcuate 
portion of the needle, while pin 146 supports the pin at the inner arcuate 
portion 8 of the needle 9. The barrel portion 7 of the needle 9 fits 
against a protruding stop 148 located on the gripper pin assembly 152 of 
the gripper 155 as shown in FIG. 10(b). The location of the stop 148 may 
be adjusted to accommodate the engagement of different size surgical 
needles. In the preferred embodiment, the gripper pin assembly 152 is 
replaceable with other gripper pin assemblies having the stop 148 
positioned to accommodate different sized surgical needles. Note that in 
FIGS. 10(a) and 10(b), the suture receiving end portion 7 of needle 9 
extends below the gripper pin assembly 152 of the multi-axis gripper 155. 
This enables placement of the suture receiving end 7 of the needle within 
the swage dies of the swaging assembly as will be explained below. 
The three pin needle engagement configuration shown in FIGS. 10(a) and 
10(b) ensures that needle 9 will not be displaced when the swage dial 150 
is rotating, or, when the multi-axis gripper 155 is being retracted or 
extended. In the preferred embodiment, pin 142 is spring loaded and is 
retractable within guide 147 to release its grip of needle 9 when a needle 
is being transferred thereto or, when automatic swaging and pull-testing 
occurs. Retraction of pin 142 is activated by depressing plunger 149 by a 
suitable push rod or cam 143 as shown in the Figures. Pin 142 is biased 
back into the needle engaging position as shown in FIG. 10(b) by 
retracting the push rod or cam 143. 
As illustrated in FIG. 1, the rotatable swage dial assembly 150 includes 
four multi-axis gripper stations where simultaneous needle operations are 
performed. In the detailed illustration of FIG. 6, the swage dial assembly 
150 includes a swage plate 110 having four multi-axis gripper stations 
145a, 145b, 145c, 145d spaced equally thereon. The swage plate 110 is 
rotatably mounted at a central hub 109 and operable to rotate under the 
control of a control system computer 99. In the preferred embodiment, a 
reciprocating carriage is provided at each multi-axis gripper station of 
the swage dial assembly 150. For instance, as shown in FIG. 6, multi-axis 
gripper station 145a includes reciprocating carriage 151a, while station 
145b includes reciprocating carriage 151b, station 145c includes 
reciprocating carriage 151c, and station 145d includes reciprocating 
carriage 151d. Mounted to each reciprocating carriage 151a,b,c,d for 
retractable movement therewith, are multi-axis grippers, one of which 155 
is shown connected to gripper mount 150c in FIG. 6. 
As previously mentioned, each reciprocating carriage 151a,b,c,d and the 
multi-axis gripper 155 connected thereto is movable from a retracted 
position to an extended position. When the gripper 155 is in the retracted 
position shown in FIG. 7(a), the needle 9 may be conveyed to a different 
station as the swage dial rotates; when the gripper 155 is in the extended 
position as shown in FIG. 7(b), the needle is in one of the active 
stations, such as the automatic swaging station. The swaging station and 
the automatic pull-test station are both described in further detail in 
respective copending patent application Ser. No. 08/181,599 and Ser. No. 
08/181,601 assigned to the same assignee of the present invention. 
The process for extending the multi-axis grippers 155 for suture insertion 
will now be explained. As shown in FIGS. 7(a) and 7(b), each cam follower 
165a(b,c,d) is mounted to a cam slide 164 at one end of the reciprocating 
carriage 151, and the multi-axis gripper 155 is connected to the cam slide 
164 at the other end. Cam slide 164 is slidable within stationary guides 
166,167 and is adapted for reciprocal movement when the cam follower 165 
is actuated. In the preferred embodiment shown in FIG. 8(a), cam follower 
165 is a roller that fits within cam tracks of a rotatable cam dial 
assembly 120. Cam dial assembly 120 is shown in FIG. 8(a) as comprising a 
cam dial plate 125 having four cam tracks 160a,b,c, and 160d which 
correspond to a multi-axis gripper stations 145a,b,c, and 145d, 
respectively. Each cam follower 165 is positioned within each respective 
cam track at each station for movement therein. For instance, as shown in 
FIG. 9, cam follower 165a is positioned within cam track 160a and cam 
follower 165c is positioned within cam track 160c. Also in FIG. 9, cam 
dial 125 is positioned above swage dial 110 and mounted coaxial therewith. 
The cam dial 125 is rotatable about a central shaft 199 and controlled by 
a separate rotary indexing transmission (not shown) so that it may rotate 
separately from the swage dial plate 110. 
FIG. 8(a) shows cam follower 165a in a first retracted position within the 
cam track 160a. When in this position, reciprocating carriage and 
consequently multi-axis gripper 155 are in their retracted position as 
shown in FIG. 7(a) discussed above. To extend the multi-axis gripper 155 
in place at its respective station, the cam dial plate 125 is rotated in 
the clockwise direction with respect to the swage dial plate 110, as 
indicated by the arrow in FIG. 8(a), for approximately 45-55 degrees, 
forcing cam follower 165a in its cam track 160a to move toward the 
periphery of the dial as shown in FIG. 8(b). Consequently, the cam slide 
164, reciprocating carriage 151a, and the multi-axis gripper 155 move to 
the extended position as shown in FIG. 7(b) and discussed above. To move 
back to its retracted position, the cam dial plate 125 is rotated in the 
counter clockwise direction with respect to the swage dial plate 110 for 
approximately 45-55 degrees, forcing cam follower 165a in its respective 
cam track 160a to move back to its retracted position (FIG. 8(a)). 
Consequently, the cam slide 164, reciprocating carriage 151a, and the 
multi-axis gripper 155 move to the retracted position as shown in FIG. 
7(a) and discussed above. 
It should be understood that when cam dial plate 125 rotates with respect 
to swage dial 110, each multi-axis gripper 155 is either extended or 
retracted in its respective cam track. Thus, the system is designed so 
that all processes performed at each station occur simultaneously and for 
approximately the same duration of time when the multi-axis grippers are 
in their extended position, for e.g., for needle pick-up, for needle 
swaging, or, for needle pull-testing. The timing of the system is operated 
under the control system, a detailed description of which can be found in 
copending patent application Ser. No. 08/181,607, assigned to the same 
assignee of the present invention. 
When the multi-axis gripper 155 is retracted, the needle engaged thereby 
may then be indexed to a different station for further processing. To 
index the needle to another station, both swage dial plate 110 and cam 
dial plate 125 are rotated together for approximately 90 degrees to 
position each multi-axis gripper at the next station. For example, when 
the cam dial plate 125 and the swage dial plate 110 are simultaneously 
rotated 90 degrees counterclockwise in FIG. 1, the gripper 155 that had 
received the needle at station 100 is now indexed to the position 
corresponding to station 200 for swaging a suture thereto. Similarly, 
after swaging, the cam dial plate 125 and the swage dial plate 110 are 
simultaneously rotated counterclockwise so that the armed needle at 
station 200 is indexed to the pull testing station 300 for pull-testing 
thereof. The operations performed concurrently at each station about the 
swage dial increases throughput to provide an output of pull-tested armed 
surgical needles at a rate of approximately 60 per minute in the preferred 
embodiment. 
Automatic Swaging Station 
As previously mentioned, the automatic swaging station 200 of the needle 
threading and swaging system 10 is where the suture of indefinite length 
is drawn, cut, and inserted within the suture receiving end of a surgical 
needle for swaging thereof. 
At step 19 of FIG. 3(a) the indefinite length of suture material is loaded 
at one end of the payoff assembly. In the preferred embodiment, the payoff 
assembly is embodied as a drawing tower 220 shown in FIG. 12(a). The 
drawing tower 220 comprises left side rail 222 and right side rail 224 
both mounted on suitable mounting block 225 and defining a drawing bed for 
drawing an indefinite length of suture material along a drawing axis 
therebetween. Located parallel to the left and right side rails 222,224 
and suitably connected thereto are respective left guide rod 226 and right 
guide rod 228. The first gripper means or right gripper 232 reciprocates 
up and down along right guide rod 228 while the second gripper means or 
left gripper 230 reciprocates up and down the left guide rod 226. Each of 
the grippers 230,232 grip the suture material that is fed from a spool 
through pulley 235 located at the bottom of the drawing tower 220, and 
carries the material to the upper end of the tower. The right gripper 232 
is mounted on right gripper carrier 233 for vertical movement along right 
guide rod 228, and the left gripper 230 is mounted on left gripper carrier 
231 for vertical movement along left guide rod 226 as shown in FIG. 12(a). 
FIG. 11 illustrates a gripper 232 (and 230) having a gripper arm drive 261 
that is pneumatically operated to drive pair of retractable gripper arms 
265a, 265b toward each other to a suture gripping position, or, away from 
each other to an open position. Each retractable gripper arm is provided 
with a non-metallic pad 266a, 266b for gripping the suture material 255 at 
a free end thereof when actuated to the gripping position. To release the 
grip of the suture, gripper arms 265a,265b are retracted approximately 180 
degrees apart in the direction indicated by the arrows of FIG. 11 to the 
open position. When in the open position the gripper arms 265a', 265b' do 
not interfere with the motion of the other vertically moving gripper as it 
reciprocates along the respective left or right rod, nor will it interfere 
with the cutter assembly 280 that cuts the strand to a predetermined 
length as will be explained below in view of FIG. 14. The retractable 
nature of the grippers and of the cutting assembly enables single drawing 
axis operation. 
As mentioned above, each gripper carrier and gripper thereof is designed to 
advance vertically along the respective left and right rods. As shown in 
FIG. 12(a), the right gripper 232 and gripper carrier 233 is driven by 
right servo motor 238 which is mounted to the right side rail 224 by right 
motor mounting bracket 239. Similarly, the left gripper 230 and gripper 
carrier 231 0 is driven by left servo motor 236 which is mounted to the 
left side rail 222 by left motor mounting bracket 237. In the preferred 
embodiment, both left and right servo motors are interfaced with and 
controlled by the control system computer 99. As shown in FIG. 12(a), 
right servo motor 238 drives timing belt 243 which consequently enables 
vertical positioning of right gripper carrier 233 along right rod 228, 
while the left servo motor 236 drives timing belt 241 which consequently 
enables vertical positioning of left gripper carrier 231 along left rod 
226. As FIG. 11 illustrates, timing belt 243 is clamped to its respective 
gripper carrier 233 by a timing belt clamp 268 located on the back of the 
gripper carrier. A similar timing belt clamp (not shown) is provided on 
gripper carrier 231 for clamping timing belt 241 to enable vertical 
movement of gripper 230. FIG. 12(a) shows timing belt 241 engaging upper 
left pulley 245 and lower left pulley 246 as well as idler pulleys 247,248 
which are part of tensioner block 244 that adjusts the tension of the 
timing belt 241 and consequently of left gripper carrier 231. Likewise, 
FIG. 12(a) shows timing belt 243 engaging upper right pulley 251 and lower 
left pulley 252 as well as idler pulleys 253,254 which are part of 
tensioner block 245 that adjusts the tension of the timing belt 243 and 
consequently of right gripper carrier 233. 
FIG. 12(a) shows the tip and cut carrier 180 positioned along shafts 204 
and 205 which are located parallel to respective left and right rods 
226,228. Tip and cut carrier 180 provides the support for tipping assembly 
290 that applies heat to a specific location of the suture material, and 
also provides support for the cutter assembly 280 that cuts the suture 
material. In the preferred embodiment, vertical movement of the tip and 
cut carrier 180 is accomplished by cranking handwheel 208 shown in FIG. 
12(b). Other embodiments may implement a computer controlled servo motor 
to vertically register the tip and cut carrier 180 prior to cutting the 
material. 
As illustrated in FIG. 12(b), cranking handwheel 208 actuates a gearbox 213 
that rotates chain drive sprocket 214. The gearbox 213 is mounted on a 
gearbox mounting bracket 122 which, in turn, is mounted to frame member 
299. A cable chain 215 is engaged with chain drive sprocket 214 to actuate 
movement of the tip and cut carrier 180 as shown in FIG. 12(b). The cable 
chain 215 also engages chain idler sprockets 218 and 219 which are 
rotatably mounted to upper tensioner pulley bracket 221 and lower 
tensioner pulley bracket 223, respectively. The vertical positioning of 
tensioner pulley brackets 221,223 may be adjusted to vary the slack in 
cable chain 215. Cable chain 215 also engages chain idler sprockets 227 
and 229 which are suitably mounted on left side rail 222. As shown in FIG. 
12(a), the back 211 of tip and cut carrier 180 is clamped to cable chain 
215. 
Both the stroke of the grippers 230,232 and the positioning of the tip and 
cut carrier 180 along drawing tower 220 dictates the length of the 
material that will be cut. For instance, as shown in FIG. 12(a), proximity 
sensors 273,274, and 275 are positioned vertically at different heights 
along the drawing tower 220 to enable predetermination of the length of 
suture material to be cut. Specifically, the locations of the proximity 
sensors 273,274, and 275 sense the positioning of the tip and cut assembly 
180 as controlled by handcrank 208 in order to notify the control system 
99 to change the reciprocating travel of grippers 230,232. Also as shown 
in FIG. 12(a), proximity sensor 270 is mounted at a position along the 
right side rail 224 to verify that right gripper 232 has reached a desired 
position at the upper end of the tower 220 and notify the control system 
99 accordingly. Likewise, a proximity sensor (not shown) is mounted at the 
desired height along the left side rail 222 to verify that left gripper 
230 has reached its desired position at the upper end of the drawing tower 
220. 
To feed the indefinite length suture material up the length of the drawing 
tower, the suture material 255 is first manually threaded through eyelet 
256 and through optional knot detector 257 which senses any sudden change 
in the thickness of the suture material as shown in FIG. 13. Detection of 
a knot in suture material 255 will trigger the control system 99 to 
discard the cut strand of material at a subsequent operation. 
Additionally, the suture material may be threaded within a tensioning (or 
dancer) assembly 259 which comprises a plurality of vertically spaced 
apart cones 223 each of which may be positioned laterally to increase or 
decrease the tension of the suture strand 255 as shown generally in FIG. 
13. 
The suture material 255 is then advanced over pulleys 235a and 235b located 
at the bottom of the drawing tower 220, and around pulley 212 which is 
mounted on the lower portion of tip and cut carrier 180 that is 
illustrated near the center of the tower as shown in FIG. 12(a). Note that 
the lower threading pulley 235b, guide pulley 212, left gripper 230 and 
right gripper 232 are vertically aligned so that the cutter assembly 280 
will always cut horizontally across the strand of material as will be 
discussed in detail below. 
Under the control of the control system computer 99, the right servo motor 
238 is enabled to drive the lead (right) gripper vertically along right 
rod 228 to register the tip of the indefinite length suture strand 255 for 
positioning within the suture receiving opening 7 of a precisely oriented 
surgical needle shown engaged by the multi-axis gripper 155 at the swaging 
assembly 390 located at the top of the drawing tower 220 as shown in FIG. 
12(a). To accomplish this, the lead gripper servomotor advances the lead 
gripper for a long stroke distance, which may range from 12 inches to 36 
inches depending upon the length of said suture strand desired, but is 
16.1 inches in the preferred embodiment. The long stroke moves gripper 232 
from a home position just above the tip and cut carrier 180 and below the 
cutter assembly 280, to the position slightly below swaging assembly 390 
as shown in FIG. 12(a). 
Simultaneous with the positioning of the lead gripper 232 during the long 
stroke, the other servomotor, for e.g., servomotor 236, positions the 
bottom gripper, for e.g., left gripper 230, along left rod 226 at the home 
position preferably above the tip and cut carrier 180 and below the 
position of the cutter assembly 280 as shown in FIG. 12(a). It is 
understood that the lead gripper is gripping the material 255 at all times 
during the long stroke, while the bottom gripper is in its open position 
and not gripping. The process of advancing suture material 255 by 
alternating grippers at each cycle eliminates the recycle or return time 
for retaining the gripper to the original position. This makes faster 
machine speeds and hence, higher production rates possible. 
To insert the tipped end 258 of the suture material within the suture 
receiving end 7 of surgical needle 9, the lead gripper 232 again advances 
the suture material 255 for a short stroke distance of about 1.9 inches, 
so that the tipped end 258 will advance precisely within the suture 
receiving opening 7 of needle 9 for a swaging operation to take place at 
the swaging assembly 390. 
As the tipped end 258 of the suture material is advanced during the short 
stroke distance, a portion of the material 255 that has been heated by 
tipping assembly 290, (explained hereinbelow), advances vertically to a 
position just above the home position of the left gripper 230 and adjacent 
the cutter assembly 280. Then, as automatic swaging of the tipped end 258 
to the surgical needle occurs, the left gripper 230 (lower gripper) is 
actuated to grip the material 255 at or below the tipped portion 278 i.e., 
the portion of the suture material heated by tipping assembly 290 as shown 
in FIG. 12(a), and the cutter assembly 280 is actuated to cut the tipped 
portion 278 of the suture material 255 so that the left gripper 230 is now 
gripping an indefinite length suture strand 255 having a tipped end 258. 
Simultaneous with the engagement of left or bottom gripper 230, the top or 
right gripper 232 is actuated to release its grip on the definite length 
suture material. 
Heater Assembly 
Immediately after advancing the long stroke distance and prior to advancing 
the short-stroke distance, the top gripper is temporarily halted so that a 
portion of the suture material 255 may be heated (tipped). Heating of the 
suture under tension and the subsequent cooling thereof will stiffen the 
material and aid in the positioning and subsequent swaging of the tip of 
the material within the confines of the surgical needle. The operation of 
the tipping assembly 290 mounted on tip and cut carrier 180 will now be 
explained as follows: 
As shown in FIG. 18, the tipping assembly 290 is essentially an oven 
comprising a heat exchanger unit 295 that heats the air in the heater 
cavity 296. When a pulse of incoming air is provided to the heat exchanger 
input 297, the heated air is displaced and it provides a pulse of heated 
air to a vertical cylindrical cavity 291 as shown in FIG. 12(a). As shown 
in FIG. 18 the heated air is forced through horizontal orifice 294 for a 
predetermined duration so that the length of suture material 255 suspended 
in tension through vertical cavity 291 will be heated. The control system 
computer 99 controls the duration of the heat pulse so that the material 
is adequately heated and will have sufficient time to cool before the 
cutting operation. Preferably, the temperature of the heated pulse may 
vary depending upon the surface area of the strand suspended through the 
vertical cavity 291. Preferably, the tipping assembly 290 is positioned 
slightly below the bottom or left gripper 230. As mentioned above, this is 
required so that when the suture material 255 is advanced the short stroke 
distance, the tipped portion 278 of material 255 will advance a 
corresponding distance so that it may be cut by cutter assembly 280. This 
ensures that the bottom gripper, e.g., left gripper 230, will grip the 
material having a new tipped end 258 for the next suture draw/insert 
cycle. 
It should be understood that various other "tipping" technologies will work 
depending upon the type of suture material that is being processed. For 
instance, when VICRYL.RTM. and VICRYL.RTM.-like suture materials are used, 
tensioning of the strand, in addition to hot air application to a strand 
will enable the surface thereof to be melt and recast to form a stiffened 
tip. The application of tension in addition to a heated, grooved, die for 
forming the tip diameter of VICRYL.RTM. suture materials may also be used; 
however, the use of a die to form the tip diameter, requires closer 
control of the strand location to ensure that a tip gets into the die 
groove for every cycle. For wax-impregnated suture materials like silk, 
the application of tension only at predetermined locations, will form a 
stiffened portion of the suture strand at those locations. Another tipping 
method for use with braided suture materials, involves applying and 
penetrating the braid with a dilute resin material such as General 
Electric's VITEL.RTM. having a high solvent content, and quick drying the 
applied portions with hot air while maintaining tension of the suture 
strand materials to form a stiffened tip thereof. 
Cutter Assembly 
FIGS. 16-17(b) illustrate in detail the cutter assembly 280 which is 
suitably mounted to the tip and cut assembly 180 as shown in FIG. 12(a). 
As shown in FIG. 16, the cutter assembly comprises overcenter linkage 282 
having a link arm 283 pivotally connected at one end thereof. A pivotal 
locator arm 285 is fixedly connected to link arm 283 at a second end 
thereof and is illustrated in FIG. 24 as substantially transverse thereto. 
The other end of locator arm 285 is pivotally connected to a stationary 
guide mechanism 286. Note, that all pivotal linkages described herein are 
simple pin linkages, the actuation of which creates the dwell moment for 
cutting the suture strand and obviates the need for complicated cam, 
slots, and sliding mechanisms. 
As shown in FIG. 17(a), the stationary guide 286 is located in a plane 
perpendicular to the drawing axis of the suspended strand of material 255, 
and is located a distance from the strand approximately equivalent to the 
length of locator arm 285. In addition, overcenter linkage 282, locator 
arm 285, and cutting blade 289 all lie in planes perpendicular to the 
drawing axis of the strand of material 255. 
A retractable ball slide 288 is mounted on the stationary guide 286 and 
coupled to overcenter linkage 282 for moving the overcenter linkage and 
blade 289 along the stationary guide 286 in the direction indicated by 
arrow "A" in FIG. 16 from a cutting position to a retracted position shown 
in FIG. 17(a). As the ball slide 288 moves overcenter linkage 282 to a 
retracted position, the locator arm 285 is pivoted away from the strand 
255 and the blade 289 is retracted. Thus, when the cutter assembly 280 is 
in the retracted position prior to cutting of the strand and immediately 
thereafter, the blade 289 and locator arm 285 do not interfere with the 
reciprocating motion of the grippers 232,230 along the drawing tower 220, 
nor do they come in contact with the suspended strand 255. In the 
preferred embodiment, pneumatic air cylinder 281 enables reciprocating 
movement of the ball slide 288 along stationary guide 286 as shown in FIG. 
16. 
When cutting the strand of material 255, the retractable ball slide 288 
reciprocates in the direction toward the strand 255 indicated by arrow "B" 
in FIG. 17(a) to bring the overcenter linkage 282, cutting blade 289 and 
locator arm 285 to the cutting position shown in FIG. 17(b). As the 
overcenter linkage 282 moves to the cutting position, the link arm 283 
translates the movement of the ball slide 288 into pivotal movement of the 
locator arm 285. Locator arm 285 is provided with a V-shaped support notch 
287 which functions to engage and position the strand of material 255 to 
be cut as the arm is pivoted into the cutting position. The V-shaped notch 
also functions to support the strand on two sides of the strand 55 while 
it is being horizontally cut on a third side. This enables clean, 
broom-free cuts especially of multi-filament suture material, which has a 
tendency to form a broom end when the strand is under tension and is cut 
by scissors, or, when the multi-filament strand is sliced and otherwise, 
not properly supported. 
The cutting blade 289 of cutter assembly 280 is fixedly mounted to 
reciprocating ball slide 288 at a slight angle relative thereto and in a 
plane parallel with that of the locator arm 285. In the preferred 
embodiment, a single action by the pneumatic air cylinder 281 will enable 
movement of the reciprocating ball slide 288 along stationary guide 286. 
This consequently enables pivoting of locator arm 285 from its retracted 
position (FIG. 17(a)), so that V-shaped notch 287 supports the strand 255 
at two sides thereof while a third side of the strand bears upon the 
cutting edge of blade 289 as the blade moves towards the supported strand 
255 traversing the drawing axis thereof. Thus, the strand 255 is cut in a 
dwell moment of the locator arm after the locator arm 285 has pivoted in 
the direction toward the blade 289 to the cutting position shown in FIG. 
17(b). The blade 289 slices the strand of material while it is held 
stationary by locator arm 285 by virtue of the angled orientation of the 
blade with respect to the axis of reciprocation illustrated in FIGS. 17(a) 
and 17(b). In the preferred embodiment, the slice ratio is 1:1, with the 
blade 289 angled at approximately 45 degrees relative to the axis of 
reciprocation, so that the strand 255 is cut an amount equivalent to the 
distance the blade 289 traverses the drawing axis. 
Swaging Assembly 
The swaging operation taking place at the swaging station will now be 
described. FIGS. 14(a)-14(g) illustrate the multi-axis needle gripper 155 
and swaging and suture alignment dies shown in various stages of the 
suture insertion and needle swaging sequence. This sequence, and the 
interaction of the dies in relation to each other, the needle, and the 
insertion of the suture, accomplish the insert and swage function with 
minimal parts and simple motions. 
After conveying the needle to swaging assembly 390 shown in FIGS. 12 and 
13(a), the multi-axis gripper 155 is radially extended from the swage dial 
in the manner described above to position the suture receiving end 7 of 
needle 9 between the funnel shaped die opening formed at the ends of two 
swage dies 361,369 as shown in FIG. 14(a) and the partial perspective view 
of FIG. 14(b). As will be explained, swage die 361 is fixed in position 
and swage die 369 is movable laterally toward the fixed swage die 361, as 
indicated by the arrow, to accomplish swaging of the suture receiving end 
of a needle placed therebetween. A funnel shaped die opening 392 having an 
exit diameter slightly larger than the diameter of the suture receiving 
end 7 of the needle is formed when the two swage dies 361,363 are 
positioned adjacent each other as shown in FIGS. 14(e) through 14(f). In 
the preferred embodiment shown in FIGS. 19(a) and 19(b), the ends of each 
of the swage dies 361,369 are provided with recesses 321,322 respectively, 
so that the metal deformation that occurs as a result of the swaging of 
the needle 9, does not result in metal flash or spurs at the suture 
receiving end 7 of the needle. Note that different sets of swage dies may 
be provided, depending upon the size (diameters) of the needles and 
sutures to be swaged. 
To precisely position the suture receiving end 7 of needle 9 between the 
swage die opening 392 formed at the ends of two swaging dies 361,369, the 
movable swage die 369 is temporarily moved apart. In the illustration of 
the swaging assembly 390 shown in FIG. 15(a), swage die 369 is moved apart 
from the fixed swage die 361 by actuating air cylinder 395 to provide a 
force upon cylinder rod 393 to enable swage die operating lever 397 to 
pivot about screw 394 and pull movable swage die 368 a predetermined 
distance away from the fixed swage die 361. In the preferred embodiment, 
lever 397 is biased by spring 364 so that the movable swage die 369 will 
return toward the fixed swage die by the spring restoring force when the 
pressure provided by the air cylinder 395 is terminated. 
FIG. 14(c) shows die 361 in its fixed position, and movable die 369 in its 
spaced apart position prior to receiving the surgical needle 9 presented 
by multi-axis gripper 155. Suture alignment die 362, containing suture 
guide funnel half 362b, is positioned under swage die 361, and free to 
slide laterally within limits. Alignment die 362 has a tang 362a that 
protrudes into cavity 361a formed within swage die 420. Compression spring 
361c bears against the back wall of cavity 361a and tang 362a such that 
funnel die 362 slides forward until it is constrained by cavity wall 361b. 
In this position, it is forward of the center axis defined by the suture 
receiving end of the needle, and serves as a shelf 362c that helps assure 
suture receiving end 7 of needle 9 is in position for swaging. In this 
stage of the cycle, the parts are not positioned for suture insertion, and 
suture clamp 265a gripping suture 255 and stiffened end 258, are in dwell. 
Suture alignment die 368, containing funnel half 363, is fastened to swage 
die 369 by suitable fastening means, described in detail below, and 
travels with it to the open position shown. 
While the swage dies are apart, the multi-axis gripper 155 is extended to 
position the suture receiving end 7 of needle 9 within the opening 392 as 
shown in FIG. 14(c) and FIG. 15(a). After positioning the suture receiving 
opening 7 of needle 9 at the swage die opening 392, the swage die 369, and 
suture alignment die 368, are moved toward needle 9 with the resilient 
spring force present in spring 364 (FIG. 15(a)) that is sufficient to 
enable the die 369 to grip and locate the suture receiving end 7 precisely 
against fixed swage die 361 without deforming the cavity of the suture 
receiving opening 7 formed therein. Concurrently, needle retaining pin 142 
in multi-axis gripper 155 is raised by downward external force on plunger 
149, as described above, thereby releasing the needle so that its position 
is determined by the grip of swaging dies 361 and 369. The motion of dies 
368 and 369 cause the face 368a of suture alignment die 368 to come in 
contact with the corresponding face 362c of suture alignment die 362. The 
resilient force causing this motion is forceful enough to compress spring 
361c, and move funnel die 362 to the left, such that tang 362a is no 
longer in contact with cavity wall 361b. Dimensioning of dies 369 and 368 
is such that this motion results in the formation of two funnel halves 
362b and 363 defining a smooth conical shape that is coaxial with the 
suture receiving end 7 of needle 9. FIG. 14(d) shows the suture receiving 
end 7 being gripped by the swage dies 361,369 prior to suture insertion. 
Note that the exit diameter of the conically shaped funnel guide formed of 
funnel halves 362b and 363 is preferably equal to or greater than the 
diameter of the suture tipped end 258 and smaller than the diameter of the 
suture receiving end 7 of the needle 9, as shown in FIG. 14(e), so that 
the tipped end 258 of the suture strand may be easily inserted therein. 
FIG. 14(e) shows suture gripper 265a moved vertically to the insertion 
position, which causes stiffened suture end 258 to enter funnel 362b and 
363, and be guided into the suture receiving cavity 7 of needle 9 axially 
aligned therewith. Once the strand is inserted into the suture receiving 
end 7 of the needle (step 28) as discussed above, the automatic swaging of 
the suture receiving cavity occurs. In the preferred embodiment of the 
swaging assembly 390 shown in FIG. 15(a), a pneumatic air cylinder 365 
provides air pressure to actuate cam 375 that bears on lever 397 to thrust 
movable swage die 369 toward the fixed swage die to accomplish the swaging 
of the suture receiving end of the needle placed therebetween. Air 
pressure is supplied to the swage cylinder 365 via ports 366,367 under the 
control of the control system computer 99. 
FIG. 14(f) shows the completed swage stroke. The swage die 369 has been 
driven to a fixed stop by the swage cylinder, which exerted sufficient 
force to deform the suture receiving end 7 of needle 9. As deformation 
takes place, suture alignment die 368 further displaces funnel die 362, 
causing additional compression of spring 361c. In the preferred 
embodiment, the movable swage die 369 comes to an automatic stop by a 
swage stop mechanism herein described. 
As shown in FIG. 15(b), movable swage die 369 and suture alignment die 368 
are mechanically held coincident to each other by shouldered post 369a, 
the smaller diameter of which is a light press fit into the mating hold in 
die 369. Cap screw 369c, with washer 369b retain the post in die 369. The 
larger diameter of post 369a, below die 369, extends through a light press 
fit hole in funnel die 368, so that the right hand swage and funnel dies 
are linked to move together laterally during the swaging cycle. The lower 
portion of shouldered post 369a extends through funnel die 368, into 
groove 390b, which is cross milled into swage assembly frame 390a. When 
the swage stroke is performed, the swage cylinder drives this die assembly 
to the left until it is positively stopped by the lower portion of post 
369a striking wall 390c of groove 390b. This stalls air cylinder 365, so 
that the stroke of the movable right hand die assembly shown is always the 
same for repeating cycles of the machine. 
In an alternative embodiment, both swage dies 361,369 may be movable 
towards each other to accomplish swaging. Furthermore, an adjustable swage 
stop mechanism for changing the swage stroke distance of one of the 
movable dies may be provided to further control the swaging pressure 
applied to the suture receiving opening and obviate the need for a 
fine-tune positioning adjustment for a fixed swage die. 
As shown in the top view of FIG. 15(a), a needle fence assembly 398 is 
provided to ensure that the needle 39 does not tip or become misaligned 
when the end 37 of the relaxed needle is positioned between the swage 
dies. The needle fence assembly 398 comprises a needle fence plate 399 
whose distance from the tapered swage die opening 392 is adjustable 
depending upon the size of the surgical needle to be swaged. 
In the preferred embodiment, the degree of swage compression imparted on 
the needle, and resulting strength of grip by the needle on the suture, is 
adjusted by precise positioning of the fixed die 361. As shown in FIG. 
15(a), servomotor 345 drives pulley 344 via timing belt 461, which rotates 
the swage adjust screw 347. The pitch of the swage adjust screw 347 is 
selected to move sliding wedge 348 a small distance. The swage die 361 has 
a complementary ramp angle 343 at the opposite end which bears on the 
wedge 348 to retract or advance the position of the swage die 361 a 
precise distance proportional to the movement of the sliding wedge. Thus, 
the rotation of the swage adjust screw 347 and motion of the sliding wedge 
348, results in transverse movement of the swage die 361 to thereby finely 
adjust its fixed position. For example, when a larger suture is to be 
swaged to a needle, the position of the fixed die 361 may be moved further 
away from the suture drawing axis so as to provide the desired amount of 
deformation when the swaging pressure is applied to the needle by the 
movable swage die 369. In the preferred embodiment shown in FIG. 15(a), 
the control system computer 99 will send the appropriate signals to 
automatically direct the servomotor 345 to adjust the position of the 
swage adjust screw 347, and hence, the position of the fixed die 361, in 
accordance with the pull-out test values of the needle-suture bond as 
measured by automatic pull-test system as explained in further detail 
below. Specifically, appropriate control signals may be generated to 
direct the servomotor 345 to adjust the rotational position of the swage 
adjust screw 347 in accordance with stored statistical results of the 
pull-testing occurring at the pull-test station. Automatic pull-testing of 
the armed needle is desirable to ensure that the upstream swaging dies are 
optimally positioned to avoid over-swaging the needle-suture bond and 
hence, preventing the likelihood of clip-off, and, to avoid under-swaging 
the needle-suture bond to prevent the chance of pull-out. 
Immediately after the short stroke of the right or top gripper 232, the 
left gripper 230 secures the suture strand, and the suture material 255 is 
cut by the cutter assembly 280 in the manner described above and as 
indicated in step 30 in FIG. 3(b). As shown in FIG. 12(a), the cutter 
assembly 280 is positioned slightly above the left gripper 230 so that the 
indefinite length suture strand 255 will be gripped when the swaged strand 
is cut. Thus, the left gripper 230 is now gripping the suture material 255 
with a tipped end 258 and it now becomes the lead gripper. 
In the preferred embodiment shown in FIG. 12(a), a vacuum air flow is 
energized to pull the strand of material 255 toward the nylon screen 357 
to facilitate the cutting of the material thereof. After cutting of the 
indefinite length suture material 255, the tail end of the length of 
suture material that had been swaged to the surgical needle is sucked into 
a large vacuum pipe 358, that is connected to a vacuum assembly (not 
shown) by vacuum hose 359 as shown in FIG. 12(a). The vacuum created in 
vacuum pipe 358 exerts a mild tension in the strand of material to keep 
the tail end from entanglement or coming into contact with the machinery. 
However, it is mild enough to allow the strand to be pulled out of the 
pipe 275 as the armed needle is indexed for further downstream processes. 
After swaging of the needle, the movable die 369 is again retracted by air 
cylinder 365 and the pin 142 of the multi-axis gripper 155 is actuated to 
engage the armed needle in the manner described above. Subsequently, the 
multi-axis gripper 155 is retracted (step 30) to its position along the 
swage dial 150 for subsequent indexing to the pull-test station 300 for 
further processing (step 31). 
The cycle continues at the swaging station with the new lead gripper 
vertically drawing the material 255 along the height of the drawing tower 
220 to position the next strand to be cut for insertion within the 
surgical needle. The process of advancing suture material 255 by 
alternating grippers at each cycle eliminates the recycle or return time 
for retaining the gripper to the original position. 
Automatic Pull-test Station 
A test of the strength of the swaging bond of the armed needle indexed at 
the automatic pull-test station 300 may be performed as described in 
detail below and in further detail in copending patent application U.S. 
Ser. No. 08/181,607 assigned to the same assignee of the present invention 
and incorporated by reference herein. Automatic pull-testing of the armed 
needle is desirable to ensure that suture pull-test requirements are met. 
Specifically, as described in detail below, either a minimum pull-test, 
indicated as step 32 in FIG. 3(b), or, a destructive pull-test, indicated 
as step 33 in FIG. 3(b) is being performed at the pull-test station 300. 
The automatic pull-test assembly 300 for accomplishing automatic 
pull-testing of an armed surgical needle is shown generally in FIGS. 20 
through 21(c). The automatic pull-test assembly 300 generally comprises a 
load cell mounting assembly 330 for mounting a load cell 335 which 
functions to receive the armed needle 9 from the multi-axis gripper 155 
which is indexed thereto as shown in FIGS. 20 and 21(a). A needle release 
assembly 315 is provided for relaxing the armed needle from the grip of 
the multi-axis gripper 155. Pull-test fence assembly 340 is provided to 
prevent the armed needle 9 from tipping over or becoming misaligned when 
the armed needle is relaxed. Suture gripping assembly 370 containing 
retractable gripper arms 325a,b for gripping the suture 255 during the 
pull-tests, and which are connected to the weighted slide block assembly 
372 for performing the pull-test is provided as shown in FIG. 20. A 
detailed description of each of these assemblies and their interaction 
will be explained in detail hereinbelow. 
As shown in FIGS. 20 and 21(a), an armed surgical needle 9 is retained by a 
multi-axis gripper 155 and, in the manner described above, is indexed to 
the automatic pull test station 300 by the rotary swage dial 150 partially 
illustrated in the FIG. 20. To position the armed needle 9 in the load 
cell 335, the multi-axis gripper is extended from the swage dial 150 so 
that the end portion 7 of needle 9 is positioned above a corresponding 
receiving blade 336 of the load cell 335 as shown in FIG. 21(a). 
FIG. 22 illustrates a top view of the load cell mounting assembly 330 with 
load cell 335 mounted thereon. In the preferred embodiment, load cell 335 
has mounted thereon four (4) thin needle supporting blades 336a,b,c,d for 
supporting the suture receiving end portion 7 of various size surgical 
needles with the suture material 255 depending therefrom. For instance, 
load cell needle supporting blade 336a labelled "1/0" accommodates a 
larger sutures having a diameter of approximately 0.017+/-0.001 inches; 
load cell needle supporting blade 336b labelled "2/0" accommodates sutures 
having a diameter of approximately 0.014+/-0.001 inches; load cell needle 
supporting blade 336c labelled "3/0" accommodates sutures having a 
diameter of approximately 0.011+/-0.001 inches; and load cell needle 
supporting blade 336d labelled "4/0" accommodates a smaller suture with a 
diameter of approximately 0.009+/-0.001 inches in the preferred 
embodiment. Depending upon the batch of surgical needles currently being 
pull tested, the appropriate needle supporting blade 336a,b,c,d will be 
positioned to receive the needle from the multi-axis gripper. Knob 339 
located centrally on top of the load cell 335 may be manually operated to 
rotate the load cell and position the correct sized suture receiving blade 
prior to carrying out automatic pull-testing. Additionally, the load cell 
335 may be laterally positioned by moving slide handle 338 and 
consequently load cell platter 337 towards or away from the suture needle 
indicated by the arrow in FIG. 22. 
The multi-axis gripper 155 is initially positioned so that the end portion 
of armed needle 9 is supported by the appropriate needle supporting blade 
336 (e.g. blade 336b). FIG. 23 is a front cross sectional view 
illustrating the suture receiving end portion 7 of needle 9 resting upon 
the needle supporting blade 336b with the suture strand 255 threaded 
between the suture receiving guide 334. 
Non-destructive pull testing of the armed surgical needle 9 is accomplished 
as follows: 
After positioning the multi-axis gripper as heretofore described, gripper 
arms 325a,b of suture gripping assembly 370 are extended from a retracted 
position to grip the suture strand 255 slightly below the needle 
supporting blade 336 of load cell 335 as shown in FIG. 30. A gripper 
actuator 372a is provided for opening and closing gripper arms 325a,b, as 
shown in FIG. 20, and is controlled by a control system program resident 
in control system computer 99 as explained in further detail in copending 
patent application U.S. Ser. No. 08/181,607 assigned to the same assignee 
of the present invention. FIGS. 20 and 21(a) illustrate the slide block 
assembly 372 that is composed of slide rods 372b,c that are connected to a 
lower slide block 372d. Slide block 372d includes a slide finger 372e upon 
which air cylinder piston rods 374a and 379a, of respective air cylinders 
374, 379, apply respective upward and downward forces depending upon the 
type of pull-test that is to be performed. As shown in FIG. 21(a), piston 
rod 374a is shown in an extended position providing an upward force that 
supports slide finger 372e and consequently maintains slide block 372d of 
slide assembly 372 at a fixed vertical position. 
Slide block 372d is counterweighted to a net downward weight of 2 to 5 
ounces by appropriately sized counterweight 376 that acts through cable 
373, around pulley 377, and through attachment point 372h. This 
counterweight 376 acts to pull upward on slide block 372d at the 
attachment point 372h. 
To accomplish the non-destructive pull test, piston rod 374a of air 
cylinder 374, mounted on the mechanism frame 371 and controlled by system 
computer 99, is retracted from its extended position (FIG. 21(a)) 
supporting the slide finger 372e as shown in dashed line in FIG. 21(b), by 
reversing its air supply (not shown), to the position shown in the figure. 
The piston rod 374a is retracted to remove the upward force on slide 
finger 372e, as shown in the FIG. 21(b), to thereby impose the 
counterbalanced net weight of 2 to 5 ounces of slide block 372d on the 
swage attachment means of suture 255 in needle 9, in the direction of 
arrow "A". Accuracy of this system is enhanced because slide block 372d, 
suspended on slide rods 372b,c, are mounted in low friction ball bushings, 
372f and 372g, that are pressed into slide mount 371, thereby imposing 
minimal mechanical drag on the system. 
Note in FIG. 20, that the slide block mount 371 is positioned parallel to 
the axis of the suture 255 depending from the needle 9, and is located a 
distance away from the suture 255 corresponding to the length of the 
gripper arms 325a,b. 
Simultaneous with or momentarily before the slide assembly 372 is released, 
the needle release assembly 315 is actuated to enable multi-axis gripper 
155 to disengage its grip on the armed needle 9. Releasing the armed 
needle from the grip of the gripper 155 is necessary to ensure that it is 
firmly positioned on the load cell needle supporting blade 336. Moreover, 
to provide an accurate pull-test, the needle must be released so that 
there is no existing upward force that would cause false results. 
As shown in FIG. 20, needle release assembly 315 comprises needle release 
solenoid 324 that is actuated to extend pusher 326 into pivotal lever arm 
327. Pivotal lever arm 327 pivots about pin 328 to depress plunger 149 of 
the multi-axis gripper 155 at one end 329 thereof. As shown in FIG. 21(a), 
depressing plunger 149 enables pin 142 to retract within pin guide 147 to 
release the armed needle 9 engaged thereby. Further details of the 
operation of the multi-axis gripper 155 can be found in the 
above-mentioned copending patent application U.S. Ser. No. 08/181,599. 
To prevent the armed needle 9 from becoming misaligned or from tipping over 
after the multi-axis gripper 155 releases its grip on the needle, a needle 
fence assembly 340 is provided. As shown in FIG. 20, the needle fence 
assembly 340 includes vertical fence plate 342 which can be adjusted to 
lie flush against the gripper 155 to retain the armed needle in an upright 
position. Adjusting the lateral positioning of the vertical fence plate 
342 is accomplished by moving slide handle 343 for an appropriate distance 
as shown in FIG. 20. In the preferred embodiment, the configuration of the 
face of the vertical needle fence plate 342 (not shown) may be changed to 
accommodate the configurations of different size needles. 
The controlled release of the minimum pull-test is of short duration, 
preferably ranging in milliseconds. If the test is successful, i.e., the 
suture meets the minimum pull-test requirements, the needle is re-gripped 
by the multi-axis gripper 155 by deactuating the needle release solenoid 
324 (FIG. 20) which releases the force on plunger 149. The suture grippers 
325a,b are then retracted to their open position to release their grip on 
the suture 255 as controlled by the control system. Subsequently, the 
multi-axis gripper 155 is retracted and the rotary swage dial is rotated 
to convey the armed needle downstream for further processing. 
If the suture fails the minimum pull-test, i.e., if the suture 255 is 
dislodged from the surgical needle 9 as a result of the controlled 
release, the control system computer 99 is flagged so that the disarmed 
needle 39 will be ejected at the pull-test station. The dislodged suture 
strand 255 will be drawn into a vacuum assembly (not shown) and the needle 
9 will be ejected by a needle stripper assembly 380 shown generally in 
FIG. 21(a) and in detail in FIG. 24. As shown in FIG. 24, needle stripper 
solenoid 382 will be actuated by a control signal output from the control 
system computer 99 to extend needle stripper blade 385 mounted on a slide 
block 383. The needle stripper blade 385 is shown in FIG. 20 located next 
to the needle 9. Thus, when the needle is in its relaxed state on the 
multi-axis gripper 155 and the minimum pull-test fails, the needle 
stripper blade 385 is extended to remove the needle from the gripper. The 
needle will fall and be collected by appropriate collection means (not 
shown) located at the pull-test station. 
To prepare for the next armed needle to be pull-tested, the slide assembly 
372 and retracted gripper arms 325a,b are pushed back up the slide mount 
371 to their unloaded position by an appropriate upward force supplied by 
the air cylinder 374 and piston rod 374a as controlled by the control 
system computer 99. At this time, another flag may be sent for storage to 
the control system computer that indicates that the pull-test performed on 
the particular needle 9 was successful and that the armed needle may be 
conveyed downstream for packaging thereof. 
In the preferred embodiment of the minimum and destructive pull-test 
systems shown in FIGS. 20-23, the load cell 335 and the needle support 
blades 336a,b,c,d thereof comprise a piezoelectric transducer that 
measures the force applied by the suture gripping assembly to the 
needle-suture assembly 9. The transducer load cell 335 may be interfaced 
with the control system computer 99 by conventional means as shown in 
FIGS. 20 and 22, and, in the preferred embodiment, is a 1000 gram 
transducer manufactured by Techniques Co. (Model No. GS-1K). The forces 
applied to the suture 9 and measured by the load cell transducer 335 
during the destructive pull-testing may be stored for statistical purposes 
or for real-time monitoring during a swage die setup routine that may take 
place when a new batch of surgical needles are to be swaged. For instance, 
if the destructive pull-tests fail and the forces measured by the 
transducer are determined to be at the low end of a predetermined range, 
then the control system computer 99 will acknowledge this and send 
appropriate signals to the upstream swaging assembly (not shown) causing a 
fixed swaging die to be advanced an incremental amount toward the movable 
swage die, resulting in subsequent swages being stronger. Likewise, if the 
destructive pull-test passes, i.e., the forces measured by the transducer 
are determined to be above the minimum and below an upper limit, then no 
die adjustment need be made. 
As previously mentioned, the automatic pull-test assembly 300 is used to 
perform a minimum pull-test upon every armed surgical needle indexed 
thereto prior to automatic packaging thereof. A destructive pull-testing 
of the armed surgical needle is performed at every nth needle indexed 
thereto. The purpose of performing a destructive pull-test is to set the 
swage dies located at the upstream swaging station for correct maximum 
swage pull-out value. This is by necessity a destructive test, and the 
test frequency, which is programmable, is set high enough to maintain 
control of the operation, but low enough to avoid excessive product waste. 
In the preferred embodiment, this frequency is set at every 50th needle, 
but could be every 75th or 100th needle. 
Another purpose of the destructive pull test is to aid in installing a new 
swage die set during a changeover procedure, which is a procedure that is 
used to prepare the needle sorting and swaging apparatuses (swage dies) 
for processing a new batch of needles when they are of a different size 
from a previously processed batch. Contrary to the non-destructive 
pull-test described above, the pull-test apparatus is programmed for 100% 
destructive test of a swaged needle, while the swaging assembly is 
operating and feeding the armed needles to the pull-test station. The die 
adjustment system at the upstream swaging assembly will receive a signal 
from the transducer load cell 335, at each machine cycle, and quickly 
perform a correct adjustment of the swage dies. 
Destructive test pull-out values are recorded in the system computer 99 and 
are used to compute statistical process control information which is fed 
back to the machine operator through display screens. 
Destructive pull testing of the armed surgical needle 9 is accomplished 
similarly as described herein above with respect to the minimum pull test. 
However, the fundamental difference is that a fixed mechanical stroke that 
is great enough to pull the suture out of the needle replaces the minimum 
2 to 5 ounce force of the minimum pull test. 
As shown in FIG. 21(c), piston rod 379a of second air cylinder 379 located 
opposite air cylinder 374, is programmed to provide a fixed stroke against 
slide finger 372e from a non-actuating position shown in FIG. 21(a) to the 
position shown in FIG. 21(c). This results in the vertical displacement of 
slide finger 372e from a position shown by the dashed line to a position 
shown by the solid line. This further results in a downward force upon 
slide block 372d, which, through slide rods 372b and c, moves slide 
assembly 372, including grippers 325a,b and suture 255, in the direction 
of the arrow "B" as shown in FIG. 21(c). Air pressure to cylinder 379 is 
set high enough to always pull suture 255 out of needle 9. This stroke is 
limited by the top portion 372j of slide assembly 372 striking the top of 
stationary block 371. 
The force necessary to accomplish the destructive pull-test is measured by 
the piezoelectric load cell transducer 335 as discussed above. If it is 
determined by the process control algorithm (not shown) that the 
destructive pull-test forces as measured by the transducer load cell are 
lower than a predetermined range of pull-test values, the control system 
computer 90 will send out appropriate control signals to increase the 
swaging die stroke applied when swaging the suture to the needle at the 
upstream swaging station. If it is determined that the destructive 
pull-test forces as measured by the transducer load cell are higher than 
the predetermined range, the control system computer 99 will send out 
appropriate control signals to the upstream swaging assembly to move a 
fixed swage die a small incremental distance away from the suture, thereby 
decreasing the swaging pressures applied when swaging the suture to the 
needle. 
Since the destructive pull-test necessarily results in the suture 255 
becoming dislodged from the needle 9, the needle 9 is again removed from 
the grip of the multi-axis gripper 155 by the needle stripper blade 385 as 
described above. Subsequently, the gripper arms 325a,b are retracted to 
their open positions and air cylinder 374 provides the upward force to 
restore the gripping assembly 370 and slide block assembly 372 back to 
their normal position in preparation for the next pull-test. 
Automated Packaging Machine 
During the process of arming surgical needles at the needle threading and 
swaging dial 150, as described above, simultaneous packaging processes 
occur at the rotary suture wind and packaging turret 500. In essence, the 
suture wind and packaging turret 500 is adapted to be indexed forwardly in 
the direction of arrow "B" shown in FIG. 1, such that each tool nest 
located on turret 500 is adapted to be advanced in succession to a number 
of workstations located about its periphery. Further details of the 
automatic packaging system can be found in copending patent application 
U.S. Ser. No. 08/181,626 assigned to the same assignee of the present 
invention and incorporated by reference herein. 
The foregoing indexing motions of the rotary packaging turret 500 are 
implemented in order to produce a completed suture package and are 
correlated with each other through the program-controlled operation of the 
machine such that the dwelling-time periods at each of the respective 
workstation is computed to allow sufficient time for the preceding step to 
be completed at the preceding workstation or workstations. This enables a 
smooth and continuous flow of product from the automated packaging machine 
and provide for high-speed and efficient manufacturing cycles. 
Suture Wind and Package Deal 
As shown in FIGS. 25 and 26 the rotary suture wind and package turret 500 
is essentially constituted of a circular disc-shaped dial 514 having a 
plurality of tool nests 516 located thereon in uniformly spaced 
circumferential array on the upper surface 518 of the rotary package 
turret 500, and with each tool nest extending radially outwardly of the 
periphery thereof. 
Generally, as shown in FIG. 25, there are provided eight tool nests 516 
arranged at 45.degree. angular spacings from each other about the 
circumference of the dial 514. As shown in detail in FIGS. 26 through 28 
of the drawings, each tool nest 516 consists of a housing 520 which is 
fixedly mounted on the upper surface 518 of the disc-shaped dial 514 of 
rotary dial 500, and includes a portion 522 radially outwardly projecting 
from the circumferential edge 524 of the disc member 514 which is 
operative to receive and support flat-bottomed injection-molded plastic 
trays utilized in the forming of suture packages containing surgical 
needles and attached sutures, as described hereinbelow. 
As illustrated in FIGS. 26 through 28(a), each of the tool nests 516 
comprises a housing or block 520 fixedly mounted through suitable 
fasteners to the upper turret surface 518 proximate the peripheral outer 
rim or edge 524 of the dial 514 of turret 500. Each housing 520 includes a 
horizontal radially extending central bore 526 having a shaft 528 
supported on bearings 529a and 529b rotatably journaled therein, with the 
shaft being connected to a suitable drive source (as subsequently 
described). Cam rollers 530 mounted at the radially inner end 532 of the 
housing 520 are adapted to contact a cam plate dial 533 extending over the 
dial surface 518 during the rotation of the turret 500 for purposes as 
described in more specific detail hereinbelow. At the radially outer end 
534 of the housing 520, there is provided structure for supporting the 
components for forming a suture package, the latter initially comprising a 
generally flat injection-molded tray 420 for receiving and retaining 
therein a plurality of surgical needles and attached sutures; for example, 
as illustrated in FIG. 46 of the drawings, and with an applied tray 420 
cover as shown in FIG. 47, as disclosed in a copending patent application 
entitled "Multi-Strand Suture Package and Cover-Latching", commonly 
assigned to the assignee of the present application; (identified under 
Attorney Docket ETH-849), the disclosure of which is incorporated herein 
by reference. 
The radially outer structure of the housing 520 for initially mounting the 
plastic suture tray 420 includes a generally rectangular, round-cornered 
and vertically extending plate member 536 of which the outer peripheral 
surface 538 forms a cam surface, employed for a suture-winding purpose as 
described hereinbelow, and with the plate member 536 being secured to the 
radially outer end of the shaft 528 for rotation therewith. Mounted on the 
front surface of cam plate member 536 is a plate 540 having a radially 
outwardly facing, vertically-oriented support surface or platform 542 
possessing projecting guide pins 544 for the positioning and mounting 
thereon of an injection-molded plastic tray 420 adapted to be supplied 
with surgical needles and attached sutures. The cam plate member 536 and 
the plate 540 for supporting the suture tray 420 are connected with each 
other so as to be secured against relative rotation, both being jointly 
rotatable about the longitudinal horizontal axis 528a of the shaft 528 
extending through the block or housing 520. However, the plate 540 for 
mounting the tray 420 is linearly displaceable relative to the cam plate 
member 536 through the provision of cooperating slide guides 546 located 
between these elements. These slide guides 546 are disclosed in more 
extensive detail in the enlarged fragmentary illustration of FIG. 28(b), 
where they are illustrated as mating guide rails 546a and 546b, and are 
provided to facilitate the successive insertion of an array of surgical 
needles into the tray 420 which is mounted on the guide pins 544 extending 
from the support surface 542 of the plate 540 of the tool nest 516. 
The external configuration of both the cam plate member 536, i.e. its 
camming surface 538, and the support plate 540 is substantially in 
conformance with the outer shape of the suture tray, although larger in 
external dimensions than the latter. 
(1) Generally, the first of the successive workstations located about the 
rotary suture wind and package turret 500, as is the package load station 
400. As indicated at step 40 of FIG. 3(c), empty suture trays 420 are 
positioned on the radially outwardly facing platform or support surface 
542 of the plate 540 on tool nest 516, and retained thereon by means of 
the guide pins 544 extending through positioning apertures in the tray 420 
so as to be in a generally vertical orientation relative to the horizontal 
plane of rotation of the rotary dial 514. Suitable grippers of a tray 420 
feeding apparatus or mechanism (not shown) may be provided to supply empty 
trays to successive plates 540 and position the tray 420 thereon. The 
grippers may obtain individual tray 420 from a suitable supply source, 
such as a stack of trays, and position the tray 420 one each on successive 
forwardly indexed platforms 540 of the tool nests 516. Alternatively, in 
the absence of gripper mechanisms the tray 420 may optionally be manually 
positioned on the guide pins 544 of platform 540 such that the rear 
surface of each tray 420 contacts the support surface or platform in a 
flat, surface-contacting relationship so as to be firmly mounted thereon. 
In summation, at the package load workstation 400, the support surface or 
platform 542 on the plate 540 for receiving an empty injection-molded 
plastic tray 420 is indexed by rotary dial 514 into alignment with a tray 
dispensing mechanism from which a tray is gripped and removed from a stack 
of trays and pivoted into alignment with platform 542 and advanced thereon 
so as to cause the apertures in the tray to be positioned in registration 
on the guide pins 544 projecting from the platform 542. Thereupon, the 
tray dispensing mechanism is withdrawn, and placed into position to 
receive a successive tray which, when the first-mentioned tray is indexed 
forwardly by the rotary dial 514 to the next workstation, will enable a 
further tray to be mounted on a successive platform on a tool nest 516 
located on the rotary dial 514. At that time, the vertically extending 
plate 540 with platform 542 and the cam plate 536 on which it is arranged 
are oriented in a manner with the side edges thereof vertically extending, 
as shown in FIGS. 26 through 28(b) of the drawings. Alternatively, if 
desired, this procedure of positioning a tray on the platform 542 may be 
manually implemented, thereby eliminating the foregoing operative 
structure. 
Upon the withdrawal of the dispensing mechanism which positioned the empty 
tray 420 on the support platform 542, the rotary dial 514 is now in a 
condition to be indexed or rotationally advanced forwardly to the next 
workstation, in the direction of arrow "A" of FIG. 25. 
(2) The second of the successive workstations located about the rotary 
suture wind and package turret 500, and, which may be optional on the 
machine, is the package detection station 450. The package or tray 
420-detecting workstation 450, as shown in FIGS. 29 and 30, includes a 
suitable sensor 551 which is mounted on the arm of a stationary bracket 
arrangement 552 to provide assurance that a tray 420 has actually been 
physically positioned on the support surface or platform 542, and retained 
thereon by means of the guide pins 544 projecting radially outwardly 
through the apertures in the tray 420. This is indicated as step 43 in 
FIG. 3(c). Specifically, sensor 551 is interfaced with and adapted to 
provide this information to the control system 99 for the packaging 
machine as to the required presence of a tray 420 in order to enable 
subsequent packaging steps to be implemented by the packaging machine 
responsive thereto. 
In summation, this particular workstation, which is essentially optional, 
has the sensor 551 positioned in front of the rotary dial 514, such that 
upon the platform 542 on the rotary turret mounting a tray being 
positioned in indexed alignment with the sensor, the latter may ascertain 
the presence of a tray 420 and its appropriate support on the guide pins 
544 of the support platform 542. Upon a determination having been 
transmitted by the sensor to that effect to the operating and drive 
components (not shown) of the machine, the indexing rotary dial 514 is now 
in a condition to advance the tray on its support platform 542 to the next 
workstation, as indicated as step 45 in FIG. 3(c). 
Needle-Suture Load to Package Station 
(3) The third workstation 600 (as indicated in FIG. 25) indexed in the 
direction of arrow "A" shown in FIG. 25 utilizes the multi-axis gripper 
155 of the rotary swage dial 150 for inserting a specified number of 
surgical needles and attached sutures into the suture tray 420 indexed by 
the packaging dial 500 in a confrontingly opposed relation with the 
multi-axis gripper. The needles are fed by the multi-axis gripper 155 so 
as to be positioned on a suitable clamping structure constituting an 
integral portion of the suture package tray 420, such as raised components 
molded on the central bottom surface portion thereof, as shown in FIG. 46 
of the drawings. A more detailed description may be found in copending 
patent application U.S. Ser. No. 08/181,598 assigned to the same assignee 
of the present invention and incorporated by reference herein. 
Generally, the plate 540 and its support platform 542 mounting the tray on 
the guide pins 544 is indexed incrementally vertically, such as in 
upwardly spaced steps, along a relative displacement between elements 546a 
and 546b of the slide guides 546, and resultingly between the cam plate 
member 536 and plate 540, to ensure that the appropriate number of needles 
are positioned therein by multi-axis gripper 155 at their intended arrayed 
locations in the tray. This needle feeding action is facilitated through 
the program-controlled vertical incremental displacement between the plate 
540 having the tray-supporting platform 542 thereon and the cam plate 
member 536 by the relative sliding movement taking place therebetween. 
At the needle-suture load to package station 600, the each multi-axis 
gripper 155 of the rotary swage dial 150 successively positions and parks 
needles in the needle clamping structure formed in the center portion of 
the tray 420, as illustrated in FIG. 46 of the drawings. 
As is illustrated FIG. 31, an empty tray 420 has been previously mounted on 
a tool nest 516 of the main rotary turret 500. The tool nest 516 includes 
the plate 540 having the tray-supporting platform 542 which may be 
registered in increments so that the empty tray 420 may receive eight (8) 
armed needles. While the preferred embodiment described herein describes 
the invention with respect to a reduced size organizer package (RSO) which 
is adapted to be supplied with eight (8) needles, it should be understood 
that the invention could be used with equal efficiency with a 
single-needle package or other amounts of needles. 
The face of the empty tray 420 illustrated in FIGS. 32(a) through 32(c) 
shows a plurality of grooves between raised tray portions forming clamping 
structures for accommodating the sequential placement of eight armed 
surgical needles. In order to load the first armed needle into the empty 
tray 420, the tool nest 516 is indexed to workstation 600 as shown in FIG. 
31. Simultaneous therewith, the rotary swage dial 150 as described in 
detail below, indexes the multi-axis gripper 155 to workstation 600. Then, 
the multi-axis gripper 155 is extended towards the empty tray 420 to 
deposit an armed needle 9 within a first pair 418 of the eight paired sets 
of needle receiving notches 416 that are formed between protruding 
portions 419 in the bottom surface of the tray. In the preferred 
embodiment, each paired set of notches 418 is consecutively numbered and 
spaced approximately 0.25 inches apart, as shown in FIG. 32(c). In the 
disclosed embodiment, the first needle 9 loaded is in the eighth position 
as shown in FIG. 32(a). As illustrated in FIGS. 31 and 32(a) through 
32(c), the tool nest 516 assembly and, consequently, the empty tray 420 is 
slightly tilted counter-clockwise from the vertical with respect to the 
orientation of the multi-axis gripper 155 so that the curved needle will 
be accurately deposited within the notches formed in the package. This 
tilt, which may be about 10.degree.-20.degree., and preferably 16.degree. 
from the vertical, may be effected due to the contact between the cams 530 
and an angled or sloped camming surface on cam dial plate 533 at 
workstation 600. As a result of this tilting offset, the needles are 
slightly shifted relative to each other, and the sutures depending 
downwardly therefrom will not tend to tangle with each other. Under 
control of the control system computer, a solenoid 455 then actuates a 
push rod 460 to depress the plunger on the multi-axis gripper 155 so that 
it may release its grip of the armed needle 9 in the manner described 
above. 
As shown in FIGS. 31, 32(a) through 32(c), and 33(a) and 33(b), there is 
located at the workstation 600 a package elevator assembly 430 that 
registers the empty tray 420 to receive eight individual armed needles, 
one at a time. 
As illustrated in drawings, the tool nest 516 includes the fixed body 
structure 520 containing the rotatable shaft 528 at which there is mounted 
the package tray holding platform or support surface 542 and the 
previously-described structure. Most of the turret stations, which as 
shown in FIG. 25 of the drawings are in this case eight (8) in number, 
require that the tool nest 516 is precisely maintained in a non-rotated 
vertical position, as illustrated specifically in FIGS. 26 and 28(a). This 
particular vertical orientation is maintained in that the circular 
stationary cam dial plate 533 extending between the collective 
workstations is contacted by the two cam followers 530, which are in the 
form of cam rollers 530a and 530b mounted on shaft 528 so as to straddle 
the longitudinal centerline of the latter, for each of the tool nests 
mounted on dial 514. 
Prior to needle insertion at the needle inserting workstation, the tray 420 
is adapted to be rotated into a tilted orientation through preferably an 
angle of 16.degree. counter-clockwise so that needles are to be positioned 
in a correct array and orientation in the needle park structure of the 
tray. This is attained by a tool nest rotating structure, as illustrated 
in drawing FIGS. 33(a) and 33(b), operating in functional sequence 
essentially as follows: 
FIG. 33(a) is an elevational view of the needle-suture load to package 
station 600 showing the indexing turret 514 upon which the tool nest 516 
has been mounted, consisting of the tray holding plate 540, including the 
tray supporting surface or platform 542. The shaft 528 is mounted in 
suitable bearings, (i.e. 529a and 529b) so as to be freely rotatable 
within the housing 520 of the tool nest 516, if required to do so. 
As a specific tool nest 516 which has the tray mounted thereon at the first 
workstation, and which is adapted to be supplied with the needles, enters 
the needle and suture load to package workstation, in the direction of 
arrow A, the tool nest 516 enters the tilt mechanism 535. The two cam 
followers 530, hereinafter designated as cam rollers 530a and 530b, roll 
along the upper surface of the stationary cam dial plate 533, as 
illustrated by phantom lines at the left-hand side, and then pass into the 
index mechanism 535 stopping in the position shown in solid lines in FIG. 
33(b). 
A track section 541 which consists of an insert having upper surface 543 
normally in coplanar relationship with the upper surface of the cam dial 
plate 533, and which extends through a cutout 545 formed in the cam dial 
plate 533, has its uppermost position determined by shoulders 543a and 
543b bearingly contacting against mating lower surfaces 545a and 545b on 
the lower side of the stationary cam dial plate 533. Normally, the track 
section 541 is biased upwardly into the cutout 545 under the urging of 
compression springs 547 which are supported against a suitable spring 
support member 549. At this position, the upper surface 543 of the insert 
541 is in the same plane as the upper surface of the cam dial plate 533. 
A displacement cam element 551 is in a normally raised position above the 
cam rollers 530a, 530b to enable the latter to roll into the index 
mechanism 535 workstation and enabling the tilting mechanism to operate 
without any interference of components in the rest or dwelling position, 
as illustrated. 
In order to rotate or tilt the tool nest 516 for appropriate needle 
insertion, an air cylinder 553 of the mechanism 551, which is attached by 
means of suitable screws 555 to a plate structure 557 mounted above the 
camming dial plate 533; through a cylinder rod 559a of a piston device 559 
causes the downward displacement of the cam element 551. This downward 
motion is guided by a suitable sliding device (not shown). The lower cam 
surface 551a of the displacement cam element 551 exerts a downward force 
against cam roller 530b which, in turn, forces the insert 541 to move 
downwardly within the cutout 545 provided in the cam dial plate 533, 
compressing the springs 547, and thereby rotating the shaft 528 in the 
housing 520 of the tool nest 516 counter-clockwise about axis 528a. The 
downward movement continues until the upper surface portion 551b of the 
displacement cam element 551 contacts the other cam roller 530a which has 
been displaced upwardly an amount equal to the downward displacement of 
cam roller 530b, and the system reaches the end of travel, causing the air 
cylinder to maintain the position, as shown in FIG. 33(a). The foregoing 
results in a rotational movement of shaft 528 to which the cam rollers 
530a and 530b are fastened, and resultingly of the support surface 542 and 
tray mounted at the opposite other end of the shaft 528 in a 
counterclockwise direction, preferably to a tilting angle of 16.degree.. 
After completion of the needle insertion operation, this sequence is 
reversed in that the air cylinder receives compressed air so as to raise 
the displacement cam element 551. As a consequence, the springs 547 cause 
the insert 541 to be biased upwardly, causing the upper surface 543 
thereof to press against the cam roller 530b and causing shaft 528 to 
rotate clockwise. This continues until the shoulders 543a, 543b contact 
the stationary surfaces 545a, 545b at the lower side of the cam dial plate 
533, thereby stopping this rotational motion. This clockwise rotation of 
the shaft 528 causes the cam roller 530a to move a lower position until it 
contacts the upper surface 543 of the insert 541 which is now located in 
the same plane as the upper surface of the stationary cam dial plate 533. 
A suitable switch, for example, a proximity switch (not shown) now 
indicates that all of the mechanical components of this arrangement have 
been returned to the original position of FIG. 33(a), and the dial 514 
indexes the tool nest forward for the next operating cycle. FIG. 33(b ) 
shows a dashed line representation of the cam rollers 530a and 530b 
rolling on the surface of the tool cam dial plate 533 towards the right, 
and the shaft 528 being displaced from this workstation. 
This aspect provides a structure of providing a rotary tilted positioning 
of a product on an indexing turret, in this application rotation of the 
shaft 528 and tilting the package or tray mounted thereon by means of the 
support plate 536 and platform 542, such as through an angle within the 
range of 10.degree. to 30.degree., and preferably about 16.degree., due to 
the parallel offset distance between the camming surfaces 551a, 551b on 
the displacement cam element 551 which contact the cam rollers 530a and 
530b. 
In FIG. 33(c) there is disclosed schematically an alternative design, 
similar to the foregoing, however, in which the individual structural 
components of the tilting arrangement are combined into an integral 
modular unit. 
A shaft 446 of elevator assembly 430, as shown in FIG. 32(a), raises the 
plate 540 essentially vertically but slightly skewed (at about 11.degree.) 
in 0.25 inch increments to sequentially receive eight needles from the 
multi-axis gripper 155 as described above. In this embodiment, the 
rotation of the swage dial 150 supplying armed needles from the pull-test 
station 300 at a rate of approximately 60/min. is synchronized with the 
vertical incrementing of the plate 540 mounting the tray 420 to maximize 
production rates. For example, after inserting the first armed needle 9 
into the empty tray 420 into the paired notches numbered "8" as described 
above, the elevator shaft 446 raises the plate 540 vertically for 0.25 
inches so that the next armed needle 9 may be deposited in the pair of 
notches 418 numbered "7." Simultaneous with the registering of the tool 
nest plate 540, the rotary swage dial 150 indexes the next multi-axis 
gripper 155 carrying the second armed needle, so that it may insert the 
next needle in the second position (notch "7") of the tray 420. This 
process takes place eight (8) times to fill a reduced size organizer 
package containing eight (8) armed surgical needles. After the eighth 
needle has been inserted in the package, the elevator assembly 430 
retracts the elevator shaft 446 by conventional means such as a pneumatic 
air cylinder (not shown). Thus, the tray 420 which is now equipped with 
eight armed needles is in its initial position on the tool nest 516 and 
the tray is ready for further treatment at successive workstations. 
Upon the requisite number of needles having been parked in the tray; for 
example, eight needles, the grippers 155 for transporting needles to the 
tray cease operation, and the rotary dial 514 indexes to the next 
workstation, while a subsequent tray may be positioned indexed in front of 
the needle dispensing unit so as to, in turn, be capable of being equipped 
with needles and attached sutures, as was the preceding tray 420. 
Needle Detecting Station 
(4) The optional fourth of the successive workstations located about the 
rotary suture wind and package dial is the needle detector workstation 475 
which may be provided for verification of the presence and proper 
positioning of the needles and sutures having been introduced into the 
tray 420 by the multi-axis gripper 155, as described above. As shown in 
FIG. 34, needle detector unit 560 consisting of a stationary bracket unit 
561 is adapted to be positioned opposite the platform 542 indexed in front 
thereof and mounting the needle-filled tray 420, and then advanced axially 
towards the latter to enable a plurality of sensors 562 mounted on a 
housing 564 movable thereon and interfaced with control system 99 to 
ascertain that the appropriate number of surgical needles have been 
properly introduced into and parked in proper array in the tray 420 by the 
multi-axis gripper 155 at the preceding workstation 600. Upon the needle 
sensors 562 verifying to the control system 99 the presence of the 
required quantity and parking of the surgical needles in the tray 420, the 
sensors 562 and housing 564 are retracted away from the tray 420 on 
platform 542 to enable the suture wind and packaging turret 500 to index 
the tool nest 516 forwardly to a further workstation. 
Suture Winding Station 
(5) A suture winding workstation 550, to which the tray 420 is adapted be 
indexed, comprises a suture winding apparatus 570, by means of which 
sutures depending from the needles outwardly of and hanging downwardly 
from the tray 420 are wound into the confines of the tray 420, and 
particularly the peripheral channel as illustrated in FIG. 46, and as 
shown in FIGS. 35(a), 35(b), 35(c) and 36 of the drawings. The downwardly 
loosely hanging sutures extending from each of the needles, as described 
hereinbelow, are positionable so as to be tensioned in a stationary vacuum 
device or unit 572 located below the tool nest 516 supporting the suture 
tray 420 at this workstation, and to thereby cause the sutures to be 
tensioned and bundled into a compact strand, the operational sequence of 
which is illustrated in and described in more extensive detail hereinbelow 
with regard to FIGS. 35(a) through 35(c) of the drawings directed to the 
operational aspects of winding apparatus 570. 
The cam plate member 536 of the tool nest mounting the needle and 
suture-filled tray 420 on platform 542 at this workstation is adapted to 
be contacted along the cam surface 538 thereof by cam follower components 
574 located on a stylus arrangement 576 of apparatus 570, which is 
employed for guiding and winding the sutures into the peripheral channel 
of the tray 420. The stylus arrangement 576 includes a stationary cylinder 
578 having a pneumatically-actuatable central piston 580 longitudinally 
reciprocable therein for movement towards and away from the tray 420. The 
cam follower components 574 comprise articulatingly connected rollers 574a 
and 574b contacting the peripheral cam surface 538 of the cam plate member 
536, the latter of which, in conjunction with the support plate 540 
mounting the tray 420, is rotated by the computer-controlled rotation of 
shaft 528 about a horizontal central axis 528a extending normal to the 
plane of the plates 536, 540 and the tray 420 so as to facilitate winding 
of the sutures into the peripheral channel of the tray 420, as shown and 
elucidated with regard to the description of operation of FIGS. 35(a) 
through 35(c) and 36. 
Referring more specifically to the construction of the tray 420 shown in 
FIG. 46 of the drawings, which as indicated hereinabove is essentially the 
needle and suture-containing tray 420 constituting, in combination with an 
attached cover, the components of the multi-strand suture package of the 
above-mentioned copending patent application (Attorneys Docket ETH-849). 
Referring to the basic constructional features thereof, the tray 420 has a 
planar base 580 of generally rectangular configuration extending into 
rounded corners 582. Extending about the periphery of the base 580 is an 
upstanding wall 584, and spaced inwardly thereof in parallel relationship 
is a further upstanding wall 586 so as to form a peripheral channel 
structure 588 therebetween. Extending over the channel 588 outwardly from 
the inner wall 586 are a plurality of contiguously arranged essentially 
resilient retaining fingers 590, which are cantilevered so as to extend 
most of the way over the channel 588 from the upper edge of the inner wall 
thereof for preventing sutures from lifting up out of the channel. A gap 
592 formed in the array of the retaining fingers 590 along the length of 
the channel, preferably proximate the juncture or corner between two of 
the rectangular sides of the tray 420 permits the end of each of the 
sutures to emerge from the channel 588, as shown in FIG. 46 of the 
drawings. 
The central region of the base 580 of the tray 420 within the inner wall 
586 includes integral structure which provides a plurality of spaced-apart 
gaps enabling the clamping therein of the suture needles so as to "park" 
the latter in the tray 420, as is clearly shown in the drawing and 
described in detail above, and with each of the needles having one end of 
a respectively associated suture attached or swaged thereto. 
The functioning of the components of the stylus arrangement 576 for winding 
the suture into the tray 420 is described in more extensive detail in 
connection with FIGS. 35(a) through 35(c) of the drawings, illustrating 
more specifically the vacuum unit 572, a pivotable lever which is operable 
in conjunction therewith for tightening and tensioning the suture bundle, 
and the stylus arrangement 576 cooperating with the resilient fingers 590 
of the tray 420 in order to feed the sutures into the channel in a winding 
motion as the tray 420 is being rotated by its supporting platform 542 due 
to rotation of shaft 528 about axis 528a. 
Adjacent the winding station and extending over the stylus arrangement 576 
as shown in FIGS. 37 and 38 of the drawings, there is arranged a tray 
restraint device 601 which comprises L-shaped brackets 602 having upright 
legs 604 thereof fastened to a stationary surface, and top portions 606 
extending horizontally over the rotary dial 514 and the dial cam plate 533 
thereon, and being operatively connected through a suitable drive 
arrangement 608 with an inner end of the shaft 528 extending through the 
housing 520 and which is connected with the cam plate 536 and plate 540 
mounting the suture tray. A shaft 610 extends through legs 604 of the 
stationary bracket 602 and upon initiation of the suture winding 
operation, is displaced axially towards the tray 420, either pneumatically 
or electrically by control means 99 such that a restraint plate 612 
contacting the outwardly facing tray 420 surface comes into operative 
engagement with at least a center portion thereof so as to inhibit the 
tray 420 from being expelled outwardly from its mounted position on the 
platform 542 during the suture winding sequence, and, to prevent the 
sutures from being pulled out from their associated needles by the tension 
imparted to the bundled suture strands. The interengagement of the 
restraint plate 612 and the tray 420, and the rotation imparted to the 
shaft 528, will cause the shaft 610 in the leg member 604 of the bracket 
602 of the restraint arrangement to rotate in conjunction with the 
rotation of shaft 528. Upon completion of the winding procedures, the 
control system 99 will cause the restraint plate 612 to be shifted away 
from the tray 420 into an inoperative position, so as to enable the tray 
420 on its tool nest 516 to be indexed to a further workstation by the 
advance of the rotary dial 514 in the direction of arrow A of FIG. 38. 
As shown in FIG. 35(a), the rotary dial 514 has just indexed to the suture 
winding workstation with a tray 420 attached to its platform 542. In this 
position, the bundle of sutures, in this instance, eight sutures each 
respectively attached to one of the surgical needles parked in the tray, 
hang downwardly from the tray and enter the vacuum gathering device 572 
which has an internal V-section 573 wherein a generated vacuum applies 
tension to the sutures and collects and stretches them into a bundled 
strand. The vacuum is created by a vacuum being pulled from an exhaust 
port 573a which creates an airflow into the "V" shape through suitable 
vent holes 573b. The gathering of the suture bundle is indicated as step 
61 in FIG. 3(d). Concurrently, as shown in FIGS. 35(a) through 35(c), the 
entire tray supporting platform 542 and cam plate member 536 are subjected 
to rotation about axis 528a in the direction of arrow B responsive to the 
operation of shaft 528 by means of a programmable servomotor 613, as 
illustrated schematically in FIGS. 37 and 38. 
As shown in FIG. 35(a), the turret index which has moved the tray to the 
suture winding station is complete, and this motion has dwelled in 
preparation for the winding function for the sutures. 
The suture winding workstation as illustrated in FIG. 25 of the turret 500 
includes structure for rotating the package and to accomplish the suture 
winding operation. This is accomplished by a motorized driving mechanism 
as shown in FIGS. 39(a) through 39(c) and 37. The primary rotary dial 514 
as shown in FIG. 37 which has the tool nest 516 thereon containing shaft 
528 mounted in suitable bearings 529a, 529b in housing 520. 
As the winding machine is indexed for a next suture winding cycle, the tool 
nest 516 is moved into the rotational station 680 as shown in FIG. 39(a), 
indicated by arrow C. The cam rollers 530a and 530b cross a gap 682 
provided in the stationary cam dial plate 533 and enter a slot 684 formed 
by opposite parallel surfaces 686,688 formed in a driven roller 690, the 
latter of which extends partly into the gap 682 produced by a cutout 
provided in the cam dial plate 533. The lower surface 688 of slot 684 is 
normally substantially in coplanar and axial alignment with the upper 
surface of the cam dial plate 533 enabling the rollers 530a and 530b to be 
centered therein. This centering action takes place in a dwell position of 
the dial 514 in the suture winding workstation, whereby the longitudinal 
centerline 528a of shaft 528 is coincident with the centerline of the 
driven roller 690. The drive roller 690 is mounted in suitable bearings 
such as to be able to be rotated by the servomotor 613 driving a timing 
belt 692 extending from a driving roller 694 to the driven roller 690 so 
as to operatively interconnect the rollers 690, 694. 
When the winding cycle is started at the suture winding station, as shown 
in FIG. 35(a), the servomotor 613 drives the driving roller 694 which, in 
turn, drives the driven roller 690 through the timing belt 692. At the end 
of the winding operation, the driven roller 690 is stopped to cause a 
horizontal orientation to be assumed by the slot 684 and the opposite 
surfaces of the slot are coplanar or coextensive with the upper surface of 
the cam dial plate 533. The dial 514 then indexes in the direction of 
arrow D, advancing the cam rollers 530a and 530b out of the slot 684 of 
the driven roller 690 and onto the upper surface of the tool camming plate 
533, thereby locking the support plate and tray into a vertical tray 
orientation which is secured against rotation. A suitable switch, such as 
a proximity switch (not shown) assures that the driven roller 690 is in 
the horizontal slot orientation before indexing the dial 514 forwardly, 
thereby preventing any mechanical interference between components which 
could damage the latter. The rollers 690 and 694 may be suitable sprocket 
wheels, and the timing belt 692 a sprocket belt or chain. 
The programmable servomotor 613 which rotates shaft 528 having the tool 
nest 516 fastened thereto and, effectively, the support platform 542 and 
cam plate 536 for the tray 420 about its center rotational axis 528a has 
completed an initial counter-clockwise rotation in the direction of arrow 
B, causing the suture bundle to wrap around a pin 575 which protrudes from 
the suture tray towards the viewer, when looking into the plane of the 
drawing. This rotation pulls the suture bundle partially out of the vacuum 
gathering device 572, which imparts a predetermined tension to the suture 
bundle causing it to become straight and the individual strands or sutures 
to be collected into a parallel and tightly confined group. The winding 
stylus assembly 576 which is mounted on a stationary plate is shown in its 
retracted position in cylinder 578, as it is during turret index. 
In FIG. 35(b), the subsequent phase of the winding operation is illustrated 
wherein a suture positioning arm 577 has been actuated to rotate 
clockwise, bringing a roller 577a to bear against the suture bundle, 
thereby implementing two functions: 
(a) The suture bundle length is increased between the pin 575 and the 
vacuum device 572 causing additional suture length to be drawn out of the 
vacuum device and resulting in a tighter more confined suture bundle. 
(b) Moreover, the foregoing displaces the suture bundle towards the right, 
so that a winding stylus 579 having fingers or legs 579a and 579b can 
straddle the bundle in the now extended position of the stylus 
arrangement, and be dropped on the floor of the tray channel 588 (in a 
motion perpendicular to the plane of view into the drawing) with a 
reasonable assurance that the bundle strands will not become pinched or 
fall outside of the stylus legs 579a, 579b. 
FIG. 35(b) also illustrates the winding stylus assembly 576 extended 
towards the tray 420 by the extension of the air cylinder 581 until the 
stylus guide rollers 574a, 574b contact the peripheral cam surface 538 of 
the tool nest. This step is indicated as step 67 in FIG. 3(d). The air 
cylinder 581 maintains a force against the rollers 574a, 574b during 
rotation of the tray 420 for winding, acting in a manner of a spring as 
the rollers force the stylus head 579 and the slide 583 to oscillate. The 
slide oscillates within the stationary slide holder 585. 
FIG. 35(c) illustrates the commencement of the tray rotation on the support 
surface 542 for effectuating winding of the sutures. The air cylinder 
exerts a constant force on the slide 583, and through a pivot pin 587 to 
the roller assembly 574a, 574b. The stylus 579, which is mounted in the 
roller assembly is maintained at 90.degree. relative to the suture track 
by this action. The enlarged encircled detail view of FIG. 36 discloses 
the suture bundle after it is positioned below the resilient 
suture-retaining tray fingers 590. This also illustrates the manner in 
which the stylus 579 plows under the tray fingers, raising and lowering 
them progressively as it leads the suture bundle therebeneath and guides 
the bundle into the peripheral channel 588 of the tray 420. As this 
winding takes place, as indicated at step 70 in FIG. 3(d), the vacuum 
device 572 maintains a constant essentially gentle tension on the suture 
bundle as it is withdrawn therefrom, and this action continues until the 
suture bundle ends withdrawn from the vacuum device are fully inserted by 
the stylus 579 under the resilient tray fingers 590 into the peripheral 
suture tray channel 588. At this final point of the winding cycle, the 
tool nest 516 mounting the tray is rotated to position the stylus in the 
suture channel window or gap 592, as shown in FIG. 46, whereupon the 
stylus 579 is raised upwardly out of the tray and the air cylinder 
retracts the stylus assembly, i.e. the piston rod mounting the latter, to 
the position shown in FIG. 35(a). Rotation of the tool nest mounting the 
tray with the needles parked therein and the sutures wound into the 
channel 588 continues in a counter-clockwise direction until the needle 
park is vertical with the needle points extending downwardly. The rotary 
disc 514 is then indexed for the next cycle, in effect, for receiving and 
winding a subsequent tray. 
During the foregoing suture winding sequence of operation, as previously 
mentioned, the restraint device 601 continually maintains its contact with 
the tray so as to prevent the tray and the contents therein from being 
expelled from the support platform 542 on which the tray 420 is mounted, 
and also to prevent the sutures from being pulled out from the needles. 
The restraint device 601 is withdrawn from the tray 420 upon completion of 
the suture-winding procedure to enable the continued forward indexing 
rotation of rotary turret 510. Additionally, drive member 530a and cam 
followers 530 located therein are returned to a horizontal position so the 
cam followers can leave the slot 684 and re-enter on top of cam plate 533 
without mechanical interference as dial 510 indexes for the next cycle. 
(6) At the above-mentioned optional workstation 625 of FIG. 1, the package 
tray 420 and its contents are exposed to external visual inspection to 
facilitate a viewer or video camera to ascertain whether any of the 
sutures extend outwardly of the channel or tray, and whether the needles 
are properly parked in the tray and attached to their associated sutures. 
This optional step is indicated as step 73 in FIG. 3(d). 
(7) At a cover-applying and attaching workstation 650, as shown in FIG. 1, 
to which the tray 420 is to be indexed from the preceding optional 
inspection workstation, there is located a cover-applying apparatus 620 
incorporating a pressing die structure 622 for attaching a cover to the 
tray 420, as illustrated in FIGS. 40 through 42 of the drawings, and for 
producing the suture package as shown in FIG. 47. 
The process of attaching a cover to the package tray is indicated at steps 
77 and 80 in FIG. 3(d). 
The apparatus 620 which is essentially mounted on a suitable fixed support 
proximate to the perimeter of the rotary turret, includes an upstanding 
framework 624 which includes a pivot arm structure 626 pivotally mounted 
therein and being articulatable about a horizontal pivot axis 628 for 
movement between a vertical position facing the bottom end 630 of a cover 
supply hopper or chute 632 and a horizontal position facing a tray mounted 
on platform 542 which has been indexed to this workstation. For purposes 
of illustration only, in FIG. 40 both the horizontal and vertical 
positions of the pivot arm 622 are illustrated, as pivotable along the 
direction of double-headed arrow C. A cover pressing die 623 is mounted at 
the outer or free end of the pivot arm 626, with a plurality of resistant 
vacuum cups for engaging and holding the cover as it is withdrawn from 
hopper 632. 
The pivot arm structure 626 with the pressing die 623 therein, when 
upright, is adapted to engage and withdraw a tray cover which is 
dimensioned in conformance with the configuration of the tray, and in the 
presence of a tray having the needles and wound sutures contained therein 
at the workstation, the pivot arm 622 with the pressing die 623 at its 
outer free end and the cover positioned thereon is swung into horizontal 
axial alignment with the tray on the support platform 542, as shown in 
FIG. 40, and through suitable actuating means, such as by means of a 
pneumatic device 628, the arm 622 with pressing die 623 thereon is 
extended towards and into contact with the tray on platform 542 so as to 
position the cover on the tray. The pressing die 623 contains suitable 
surface structure, as shown in FIG. 42, for fastening the cover to the 
tray, as explained hereinbelow. 
The tray cover 651 is basically a flat cover which may be of a suitably 
imprinted paperboard or the like material, and is applied to be fastened 
to the tray 420 by means of pressing die 623, as shown in FIG. 47, with 
the outer dimensions of the cover as previously mentioned being 
substantially coextensive with the peripheral dimensions of the tray, and 
with the cover also having apertures 652 in registration with the 
upstanding guide pins 544 on the platform 542. 
Hereby, the surface of the pressure die 623 facing the cover includes a 
first surface portion 638 substantially in conformance with the flat 
surface of the cover 651 which has been superimposed on the tray 420, and 
includes three projecting posts 634, preferably at three sides about the 
surface 638, and as shown in enlarged scale in FIG. 48 of the drawings, 
which will engage tabs 653 which overlie recessed portions 654 of the 
tray, and cause the pre-cut tabs 653 to be displaced along three edges 
thereof, and thereby forming latching tabs 656 which are pressed in 
V-shapes downwardly into the respective recesses 654 so as to have the 
separated edge of the folded tab 656 at that particular location engage 
beneath a horizontal wall structure 658 of the tray 420 extending 
partially over the recess 654, thereby latching the cover 651 into 
cooperative engagement with the upper surface of the tray at three 
locations. 
Concurrently, a second raised die surface portion 660 on the surface 638 of 
the pressing die 623 engages into a surface region 662 defined by suitable 
raised wall structure 664 on the tray 420 shown in FIG. 46. Die portion 
660 and wall 664 form therealong a peripheral mutually cooperating shear 
edge to separate a portion 668 from the cover 651 in conformance with the 
area 662. Second die portion 660 pushes the separated cover portion 668 
downwardly into that area 662 of the tray so as to be secured therein 
separate from the remaining structure of cover 651. The separated portion 
668 is permanently retained recessed within tray 420 by one or more ribs 
671, as illustrated in FIGS. 46 and 48 which are formed in wall 664, so as 
to form a product-identifying label remaining in the tray upon subsequent 
detachment of the cover 651 from the tray 420. 
(8) Responsive to indexed forward rotation of the rotary dial 514 of suture 
wind and package machine 500 to a successive workstation, the suture 
package consisting of the needle and suture-containing tray 420 and 
attached cover 651, as shown in FIG. 47, is positioned in alignment on the 
platform 542 with a package removal unit 670, as illustrated in FIGS. 43 
to 45 and indicated at step 83 in FIG. 3(e). In FIG. 43 of the drawings, a 
pivoting arm structure 673 is illustrated in both its horizontal and 
vertical operative positions, being pivotable along the direction of 
double-headed arrow D. Suitable grippers 926 are mounted on the pivoting 
arm structure 673 which is journaled on a stationary frame 674 the latter 
of which is somewhat similar in structure to the framework 624 of the 
cover-applying apparatus 620. These grippers 926 are pivotable into a 
horizontal orientation and extend outward from arm 673 as a result of 
pneumatically operated ram 682, as shown in FIG. 43, for gripping 
engagement with the suture package. The ram 682 and gripper 926 is then 
operated to retract and withdraw the suture package from its support 
surface or platform 542 and the pins mounted thereon. 
Prior to unloading the completed package, a check is made as to the status 
of an error bit flag that may have been set during the non-destructive 
suture pull-test depending upon if the suture pull-test has failed. 
Similarly, at the needle detect station 475, a reject bit may or may not 
have been set indicating that the package does not contain the proper 
amount of needle-suture assemblies. Therefore, if it is determined that 
the reject bit had been set indicating a rejected package, the control 
system 99 will command the unload package gripper fingers 926 to release 
its grip on the package, and, essentially, drop the package into a reject 
bin as indicated at step 89 in FIG. 3(e). 
The gripper 926 with the therewith clamped suture package is then adapted 
to be pivoted upward into a vertical orientation in alignment with the 
opening 676 in the bottom 678 of a hopper or chute 680 for receiving a 
stack of completed suture packages through the upward pushing action of a 
pneumatic cylinder 682 biasing the suture packages into the chute 680, as 
shown in FIGS. 43 and 45 and indicated as step 87 in FIG. 3(e). The bottom 
678 of the chute includes a retaining lip 684 to prevent the suture 
packages from falling downwardly out of the chute. Subsequently, the 
biasing ram 682 and gripper 926 is pneumatically retracted within the arm 
structure 673 which is pivoted to its horizontal position to receive the 
next completed suture package. Alternatively, this particular, basically 
optional structure for removing the completed suture package from the 
support surface may be eliminated, if desired, and replaced by a manual 
suture package-removing operation. 
From the chute 680, the suture packages may then be removed either through 
the intermediary of a further mechanism (not shown) or manually 
transported for additional processing; for example, such as sterilizing, 
and/or additional overwrapping, or the like. 
While the invention has been particularly shown and described with respect 
to the preferred embodiments thereof, it will be understood by those 
skilled in the art that the foregoing and other changes in form and 
details may be made therein without departing from the spirit and scope of 
the invention, which should be limited only by the scope of the appended 
claims.