Abstract:
Novel adaptive stylus winding assemblies for use in winding surgical sutures in tray packages are disclosed. The stylus winding assemblies have a pivotally mounted stylus member and a biasing element to facilitate winding a suture into a suture track of a suture tray. The winding assemblies provide for reliable product supply, quality improvements and cost reductions.

Description:
FIELD OF THE INVENTION 
       [0001]    The field of art to which this invention pertains is surgical needles and surgical sutures, more particularly equipment for winding surgical sutures and attached surgical needles into suture packages. 
       BACKGROUND OF THE INVENTION 
       [0002]    Surgical needles and attached surgical sutures are well known in the art. Surgical needles and sutures are packaged in a variety of packages for delivery of the needles and sutures to the surgeon. The packages need to have a number of important characteristics including ease of loading, ease of dispensing, and protection of the needle and suture during handling, sterilization, shipping and storage. Tray-type packages having a peripheral channel for receiving a suture are commonly used to package needles and suture combinations. The tray packages have a number of advantages. For example, the packages are relatively inexpensive to manufacture and are typically molded from biocompatible, inert polymeric materials. The track packages provide excellent protection to the sutures during processing, sterilization, shipment and storage. The packages are easy to handle by the surgical staff, and sutures are easy to withdraw from the tray packages in a consistent manner without tangles or lock-ups. One particular advantage of tray packages is their ease of suture loading in high speed, automated packaging processes. Examples of tray packages are disclosed in U.S. Pat. Nos. 6,135,272, 6,047,815, 6,644,469, and 8,011,499. Tray packages are typically made with moveable doors or members that cover the top of the track to prevent the suture from moving out of the track. 
         [0003]    Surgical sutures are packaged in tray packages by using conventional winding fixtures. The fixture typically has a rotatable base with mounting pins. A tray package is mounted on the base and pins such that the top of the tray package is facing upwardly. Then a winding stylus mounted to a winding head directs a length of suture down into a track of the suture tray as the tray rotates so that the suture is placed in the track in a uniform manner. Examples of such winding fixtures and styluses are disclosed in U.S. Pat. Nos. 5,660,024, 5,664,404, 6,804,937, and 6,463,719. 
         [0004]    Although conventional winding fixtures and styluses perform adequately for their intended use, there may be deficiencies associated with such winding fixtures. For example, a stylus in a conventional winding fixture is rigidly mounted to the winding fixture and this does not allow for variations in the dimensions of tray packages resulting in potentially improper placement of the sutures in the track of the package. In addition, a stylus is typically engaged with a winding head via a bearing. As the bearing wears with time, the bearing wear may result in loosening of the stylus in the mounting assembly, which may also result in improper suture placement. 
         [0005]    There is a need in this art for novel winding styluses for use in automated suture tray winding machines that overcome the deficiencies of the prior art. 
       SUMMARY OF THE INVENTION 
       [0006]    Accordingly, a novel adaptive suture winding stylus is disclosed. The suture winding stylus has a base member. The base member has a top side, a bottom side and opposed front and rear lateral sides. A stylus member is pivotally mounted to the base member. The stylus member has a proximal end, a distal end, a top side and a bottom side. A biasing element is associated with the base member for engaging the stylus member. 
         [0007]    Another aspect of the present invention is a suture winding assembly. The suture winding assembly has a nest member for receiving a suture tray package having a winding channel. The assembly has a winding head for rotatably engaging the nest and tray package. The assembly also has a novel adaptive suture winding stylus for engaging the winding head and the tray package. The winding stylus has a base member. The base member has a top side, a bottom side and opposed front and rear lateral sides. A stylus member is pivotally mounted to the base member. The stylus member has a proximal end, a distal end, a top side and a bottom side. A biasing element is associated with the base member for engaging the stylus member. 
         [0008]    Yet another aspect of the present invention is a method of winding a suture into a suture channel of a suture tray package using the above-described suture winding stylus and suture winding assembly. 
         [0009]    These and other aspects and advantages of the present invention will become more apparent from the following description and accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a perspective view of a suture tray package mounted in a winding nest; a surgical needle is seen mounted in a needle park and the attached surgical suture is seen to have been wound in the channel of the package. 
           [0011]      FIG. 2A  is a perspective view of a winding stylus of the present invention. 
           [0012]      FIG. 2B  is a rear view of the winding stylus of  FIG. 2A . 
           [0013]      FIG. 2C  is a front view of the winding stylus of  FIG. 2A . 
           [0014]      FIG. 2D  is a right side view of the winding stylus of  FIG. 2A . 
           [0015]      FIG. 2E  is a left side view of the winding stylus of  FIG. 2A . 
           [0016]      FIG. 2F  is a bottom view of the winding stylus of  FIG. 2A . 
           [0017]      FIG. 2G  is a cross-sectional view of the winding stylus of  FIG. 2D  taken along View Line A-A. 
           [0018]      FIG. 2H  is an exploded perspective view of the winding stylus of  FIG. 2A . 
           [0019]      FIG. 3  is a partial perspective view of a winding head engaging a nest member and a tray package, with a novel winding stylus of the present invention engaging the winding head and the track of the tray package. 
           [0020]      FIG. 4  is a perspective view of a winding stylus of the present invention engaging the doors covering a winding track of a suture tray package; the tray package is engaged by a winding head and a nest member. 
           [0021]      FIG. 5  is a bottom, perspective view of a winding head with a novel winding stylus of the present invention engaging an inner track wall of the winding head with the bottom of the winding stylus facing the winding head. 
           [0022]      FIG. 6  is a perspective view of the novel winding stylus of the present invention mounted to the winding head of  FIG. 5  and engaging a tray package in a winding nest. 
           [0023]      FIG. 7  is an exploded perspective view of the winding stylus of the present invention, winding head, tray package and winding nest of  FIG. 6 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0024]    The winding fixtures of the present invention may be used in automated suture winding machinery along with tray suture packages having doors mounted over a suture channel in the packages. The fixtures (assembly) may be made of conventional materials including, but not limited to, Aluminum 6061, 316-stainless steel, M2 high speed steel, and alloy steels and the like and combinations thereof. 
         [0025]    Referring to  FIG. 1 , a nest member  10  and a suture tray package  40  are seen. The nest member  10  is seen is seen to have outer periphery  12  and inner raised platform section  20 . The nest member  10  is also seen to have bottom tracking pin groove  14  and radial tracking pin groove  18 . Platform section member  20  is seen to have oval-shaped outer periphery  22  and top surface  24 . Extending upwardly from the ends of the top surface  24  are the winding pins  26 . The suture tray package  40  is seen to have outer peripheral wall  42  and inner wall  44 . The package  40  is also seen to have base or floor member  46  having top side  47 . The section of top side  47  between outer wall  42  and inner wall  44  is seen to from the suture winding channel  48 . Extending outwardly from the top of inner wall  44  are the cantilevered doors  50  having fixed ends  52  and free ends  54 . The doors  50  are free to rotate about free ends  54  in response to an upward or downward force. In the at rest position, the doors  50  are seen to cover the winding channel  48 . In the upward, rotated position, the doors  50  allow the winding channel  48  to be accessed. Extending through the base member  46  are the openings  60 , which are aligned to receive the winding pins  26 . The needle park members  65  are seen to extend up from the top side  47  and are configured to receive a surgical needle  80  mounted to a distal end  71  of surgical suture  70 . The surgical suture  70  has a proximal end (not shown) contained in the winding channel  48 . Surgical suture  70  is seen to have several coils  75  that have been wound into suture winding channel  48 . 
         [0026]    The stylus winding fixture  100  of the present invention is illustrated in  FIGS. 2A-2H . The stylus winding fixture  100  is seen to have stylus mount base member  110 . Stylus mount base member  110  is seen to have top side  120  and bottom side  125 . The stylus mount base member  110  also has front side  112 , rear side  114 , first lateral side  116 , and second opposed lateral side  118 . Bearing mounting passage  115  is seen to extend through stylus mount base member  110 . The stylus mount base member  110  is seen to have a stylus member mounting notch  130  on top side  120 . The notch  130  is seen to be bounded by the lateral angulated sides  135  and the distal platform section  140  extending up and intersecting sides  135 . Sides  135  are seen to have pin mounting holes  137  extending therethrough. The stylus mount wee pin  142  is seen to extend up from platform section  140 . The passage  150  is seen to extend through platform section  140 , extending from the bottom side  125  through the top side  120 . Contained in the passage  150  are the compression spring  152  and the stylus mount tip  155 . The spring  152  and the mount tip  155  are maintained in passage  150  by the set screw  158 . It will be appreciated that although spring  152  is shown to be a compression spring, other conventional biasing members may be used. In addition, spring  152  is shown mounted in the stylus mounting base member  110 , but alternatively a biasing member could be mounted in a variety of manners, for example on top of surface  120 . Extending rearwardly from the rear side  114  is the bearing mounting ear  160  having opening  165 . Mounting ear  170  is seen to extend laterally from lateral side  116 ; it is seen to have opening  175 . The stylus member  180  is seen to be mounted in notch  130  by pivot pin  139 . The pivot pin  139  is seen to extend through holes  137  and pin receiving openings  214  of plate member  210 . The stylus member  180  is seen to have elongated member  190  having distal end  192  and proximal end  194 . The elongated member  190  has top side  196  and bottom side  198 . Mounted to the distal end  192  of elongated member  190  is the stylus head  200 . The head  200  is seen to have angulated upwardly extending first nose member  202  and upwardly extending second heel member  208  separated by gap  205 . Extending from the proximal end  194  of the elongated member  190  is the rear mounting plate member  210 . Plate member  210  is seen to have an axial passage  212  and opposed pin receiving openings  214  in communication with passage  212 . Also contained in the stylus mount base member  110  is the stylus mount bushing  149  contained in the opening  148  in base member  110 . Contained in bottom  125  is the cavity  126 . The cup point set screw  127  is engaged in screw threaded passage  128  and secured with hex nut  129 . The set screw  127  is used to adjust the height of the stylus member  180  with respect to top surface  120  of the mounting base member  110  in raised platform section  140 . 
         [0027]    Referring now to  FIGS. 3-6 , the novel winding stylus  100  is seen mounted to winding head  300 . Winding head  300  is mounted to winding head machine frame  400 . The winding head has downwardly extending section  302  containing pin receiving openings  305 . The winding head  300  is seen to have top outer cam track  310  which is engaged by cam follower bearing  320 . Bearing  320  is seen to be mounted in opening  115 . As seen in  FIG. 5 , the stylus  100  is engaged in the interior section  330  of head  300  by the bearings  340  and  345  that engages interior track wall  335  and inwardly extending cam member  337 . Bearing  340  is seen to be mounted from the bottom side  125  of stylus mounting base member  110  in opening  175  and bearing  345  is seen to be mounted from bottom side  125  in opening  147  of the stylus base member  110 . Constraining rod  350  is seen to be mounted on one end  352  to passage  165  in ear  160 ; the other end of the rod  358  is mounted to the winding head machine frame  305 . As seen in  FIGS. 3 and 6 , the stylus follower member  370  is seen to be moveably mounted to the nest member  10 . Follower member  370  has downwardly extending wee pin  382  that rides in groove  14  of nest member  10  and inwardly extending wee pin  386  that rides in groove  18  of nest member  10 . The follower member  370  is also seen to have upwardly extending wee pin member  390  that is inserted into bushing  148  and opening  149  of stylus mounting base member  110 . The follower member  370  is also seen to have top opening  375  for receiving the stylus mount wee pin  142 . 
         [0028]    For winding sutures into the tray of a tray package using the winding stylus  100  of the present invention with a suture winding assembly, a tray package  40  is place on the platform  20  of nest member  10  such that the winding pins  26  are engaged in the openings  60 . A surgical needle is then mounted between the needle park members  65 . The distal end  71  of attached suture  70  is then routed out from the tray package  40  in preparation for winding. Next, the winding head  300  and mounted stylus winding fixture  100  of the present invention are lowered to engage the package  40  and nest member  10 . In the lowered engagement position, the winding pins  26  are engaged by the mating pin receiver openings  305 , and the stylus mount wee pin  142  has engaged opening  375  of the follower member  370 , while the wee pin member  390  of the follower member  370  is engaged by bushing  148  in opening  149  of the stylus mount base member  110 . Additionally, the head  200  of the stylus member  180  is in engaged with the channel  48  of tray package  40 , in a position to open and close doors  50 . 
         [0029]    As seen in  FIG. 3 , the winding head  300  has engaged nest member  10  containing tray package  40 . The stylus head  200  is seen to be engaged in channel  48  of tray package  40 . The suture winding head  300  is in a ready position to commence suture winding by rotating head  300 , thereby causing package  40  and nest member  10  to rotate. As seen in  FIG. 4 , this rotation causes the stylus head  200  to open and close the doors  50  to permit insertion of the free end of the suture  70  as coils  75  are formed in channel  48 . 
         [0030]    The novel winding stylus  100  of the present invention allows a suture to be wound in channel, such as channel  48 , of a tray package, such as package  40 , in a consistent manner while compensating for irregularities in the package, thereby extending the life of the bearings mounted to stylus mount member  110 . Other advantages of the novel stylus of the present invention having a pivotally mounted spring biased stylus member include the ability to wind sutures in a track of a tray package in a consistent manner while compensating for normal variations in tray package dimensions resulting from manufacturing processes and material variations. The novel winding styluses also compensate for movement caused by bearing wear, allowing the winding equipment to stay in service longer before a shutdown to replace bearings. These benefits are accomplished by the novel winding styluses of the present invention in the following manner. The innovative adaptive stylus  100  of the present invention resiliently maintains contact with the bottom surface of the channel  48  of tray package  40  ensuring a reliable winding process and consistent operation. Other advantages include better process capability by quality improvement on miss-wind and suture damage reduction (greater than 50% improvement), and, overall equipment efficiency (OEE) improvement by availability and yield increase. Since the novel adaptive stylus fixture of the present invention reduces the mechanical adjustment and maintenance interventions, the machine availability is increased. Also, the fixture and methods of the present invention provide winding yields that are high due to miss-wind and suture damage defect reduction. The adaptive stylus fixtures of the present invention also drive cost improvement through labor and cost reductions resulting from, among other things, less adjustments and less part replacements that are required during use. 
         [0031]    Although this invention has been shown and described with respect to detailed embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail thereof may be made without departing from the spirit and scope of the claimed invention.