Abstract:
A hand held opener for opening a frangible closer comprising a handle adapted to be gripped by an operator, a motion actuator operatively connected to the handle, a first shaft connected to the motion actuator, a second shaft connected to the motion actuator, a first gripper portion on the first shaft adapted to grip the frangible closer in a first location, and a second gripper portion on the second shaft adapted to grip the frangible closer in a second location wherein the motion actuator provides reciprocal movement to the shafts to rotate the frangible closer in one direction and to rotate the frangible closer in a direction opposite the first direction.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 61/119,592, filed Dec. 3, 2008. 
    
    
     FIELD OF THE INVENTION 
     The instant invention relates to a hand held opener to open frangible closers or stoppers including such closers or stoppers for medical tubing. 
     BACKGROUND 
     Frangible closers are closers, pins or stoppers primarily inside tubing or conduits, or inside bag or container ports, to block fluid flow through such tubing or port. Such closers can be broken which opens the tubing or port to permit fluid flow there through. The opening of such stoppers or closers is achieved by external manipulation of the tubing conduit or port without penetration of the sterile or closed condition of the system containing the tubing or port. Such closers or stoppers are manipulated from outside the tubing or port by an external force typically produced by an operator or user of the tubing or system. This force breaks the frangible pin or closer or stopper portion to permit fluid flow through the tubing or port. The force needs to bend or move the frangible closer in two opposite directions to achieve the pin, closer, or stopper breakage. 
     Generally, frangible closers are manually manipulated to open the tubing or port as described above. Such manipulation requires the operator to grasp the frangible area with both hands and then to twist, bend or rotate such area in one direction followed by a twist, bend or rotation in the opposite direction. This movement is required because a typical frangible closer needs to be broken in two opposed locations. This motion is generally achieved by wrist rotation and may need to be repeated on each side for a complete break of the internal pin, stopper or closer. Complicated multiple disposable or tubing lines may require an operator to open a number of frangible openers or stoppers which may result in wrist or hand strain or a repetitive motion injury. 
     A need exists for a frangible opener, which can be used with apparatus that uses medical tubing or disposable sets. Such apparatus can be a blood component separation centrifuge that utilizes a closed system disposable including blood tubing and frangibles during the process of separating a biological fluid such as blood into components. 
     SUMMARY 
     One object of the instant invention is to provide a hand held frangible opener that avoids repetitive strain injuries on the part of the user. 
     An additional object of the instant invention is to provide a hand held frangible opener that can be easily transported to apparatus utilizing medical tubing with frangible closers or stoppers. 
     One embodiment of the instant invention relates to a hand held frangible opener having a handle adapted to be gripped by an operator, a motion actuator, a first shaft connected to the motion actuator, a second shaft connected to the motion actuator, a first gripper portion on the first shaft adapted to grip the frangible closer in a first location, and a second gripper portion on the second shaft adapted to grip the frangible closer in a second location wherein the motion actuator provides movement to the shafts to bend the frangible closer in one direction and to bend the frangible closer in a direction opposite the first direction. 
     Another embodiment of the instant invention includes a method of opening a frangible opener located in tubing using a hand held frangible opener having first and second shafts operatively connected to a motion actuator comprising, gripping by an operator a handle on the hand held frangible opener, positioning the hand held frangible opener such that one side of the frangible closer fits between a gripper end of the first shaft and the opposite end of the frangible opener fits between a gripper end of the second shaft, powering the motion actuator, moving the first shaft in one direction and moving the second shaft in a direction opposite the first direction. 
    
    
     
       BRIEF DESCRIPTION 
         FIG. 1  is a schematic view of a representative disposable bag set for a centrifuge, wherein the bag set includes several frangible closers or stoppers. 
         FIG. 2   a  is a perspective view in cross section of a typical frangible closer in a closed configuration. 
         FIG. 2   b  is a perspective view in cross section of a typical frangible closer in an open configuration. 
         FIG. 3  is a side perspective view of a hand held frangible opener before opening a frangible closer. 
         FIG. 4  is also a side perspective view of the hand held frangible opener after opening the frangible closer. 
         FIG. 5  is a perspective view of apparatus for receiving a bag set and an operator with the frangible opener. 
         FIG. 6  is a perspective view of an alternative frangible opener. 
         FIG. 7  is a perspective view of the frangible opener of  FIG. 6  with the outer cover removed. 
         FIG. 8  is a partial perspective view of the gear assembly of the frangible opener of  FIGS. 6 and 7 . 
         FIG. 9  is partial perspective view similar to  FIG. 8  but shows gear movement in the opposite direction. 
         FIG. 10  is a perspective view of an alternative frangible opener. 
         FIG. 11  is a perspective view of the frangible opener of  FIG. 10  showing movement in one direction. 
         FIG. 12  is a perspective view of the frangible opener of  FIG. 11  showing movement in the opposite direction. 
         FIG. 13  is a perspective view of a frangible opener similar to  FIGS. 10-12  but with a rotary motion device to replace operator hand motion. 
         FIG. 14  is a perspective view of an alternative frangible opener using linear motion. 
         FIG. 15  is a perspective view of the frangible opener of  FIG. 14  with movement of the actuator in one direction. 
         FIG. 16  is a perspective view of the frangible opener of  FIG. 15  with movement of the actuator in the opposite direction. 
     
    
    
     DESCRIPTION 
     A frangible closer or stopper may include a flexible housing formed of polyvinylchloride polymer or other polymer with a rigid element, closer or stopper portion or pin contained therein. The housing may be inserted between lines or conduits of flexible medical tubing by solvent bonding or other well-known methods. The rigid element, closer or stopper portion or pin prevents fluid flow through the tubing or conduits. Such a frangible closer is shown at  23 ,  33  and  43  in  FIG. 1  at  23 , in  FIG. 2  and at  23  in  FIGS. 3 through 5 , and  FIGS. 8 through 16 . 
     A frangible closer may also be a rigid element, or closer or stopper portion or pin inserted into, rather than solvent bonded to, tubing or conduits. A frangible closer can also be included in a rigid port structure rather than the tubing. 
     It is further understood, that a frangible closer or stopper can be any element that blocks tubing, lines, conduit or ports until such element is manipulated to break and permit fluid flow there through, and wherein such manipulation can be done without breaking or opening the tubing, line, conduit or port itself to the atmosphere. 
     The terms frangible, frangible stopper or frangible closer are used synonymously throughout this description. 
       FIG. 1  illustrates a bag set  74  for blood separation that includes several frangible closers or stoppers. The bag set may include a whole blood collection or processing bag or container  200 , connected to tubing or conduit  500 , which is also connected to spike  1200  for anticoagulant or other fluids. Processing bag  200  may also be connected through frangible  23  to tubing or conduit  400  and through connector  1600  to conduit or tubing  170  and product bag or container  202 . Processing bag  200  further may be connected through connector  1600  through conduit  180  to alternate product bag or container  204 . Frangible  23 , before breakage and when closed, prevents collected blood product from leaving collection or processing bag  200  before processing. 
     Processing bag  200  may also be connected through frangible  33  to conduit or tubing  600 , and through conduit or tubing  600  to bag or container  203 , which may contain storage solution for a separated component. Frangible  43  may also be provided in conduit or tubing  600 . Frangible  33 , before breakage and when closed assures that collected blood remains in processing or collection bag  200  before processing. Frangible  43 , before breakage and when closed, assures that any component storage solution remains in bag  203  until needed. After processing of the whole blood or the material to be processed in bag  200 , such storage solution can flow through conduit  600  to mix with any remaining components in bag  200  or through bag  200  to component bags  202  or  204 . 
     A bag set such as that shown in  FIG. 1  may be utilized in a centrifuge apparatus such as that shown in  FIG. 5  for the separation of blood into components. Such apparatus is described in PCT Publication WO2007/001739 and PCT Publication WO2007/001754. 
     The bag set of  FIG. 1  is only one example of a bag or disposable set utilizing frangible closures. It is only a representative bag set in that the frangible opener of the instant invention may be utilized to open frangibles in any tubing, conduit or port or similar structure. 
       FIGS. 2   a  and  2   b  illustrates a typical frangible closer such as  23  shown in a conduit such as  400 .  FIGS. 2   a  and  2   b  are enlarged to better show the frangible closer  23 . Such frangible closer  23  includes U shaped portion  43  and stem or action portion  44 . Manipulation of stem or action portion  44  through representative conduit  400 , with such manipulation being in opposite directions causes U-shaped portion  47  to bend and break at the junctions where the U is formed to provide fluid passages  45  and  46 . 
       FIGS. 3 and 4  illustrate one embodiment of the frangible opener  50  of the instant invention utilized with frangible  23  for description purposes. It is understood that frangible  23  is included inside tubing, not shown. It is further understood the opener can be used to similarly open frangible closers or stoppers  33  and  43 . 
     Frangible opener  50  is to be held and operated by an operator or user of the disposable bag set  74  and its associated apparatus. Opener  50  includes an optional handle  16 , which may be curved to best accommodate the operator&#39;s hand. The handle  16  is attached to the opener  50  by bracket  14  and attachment devices such as screws, staples or nails  15 . Any number of attachment devices can be used to assure secure contact between the handle and the other parts of the opener  50 . It is also contemplated that handle  16  can optionally be pivoted or rotated about attachment devices  15  to best position the handle  16  in order to reach less accessible frangible closers. The operator may also use housing portion  1  as the handle as handle  16  is optional. 
     Attachment devices  15 , which may vary in number, attach the handle  16  to harness  2 . The harness  2  includes crosswise upper portion  20  that may be in contact through adhesive or other known attachment devices to motor  17 . Harness  2  further includes two side portions  21  and  24 , one of which is connected to bracket  14  through attachment devices  15 . Harness  2  further includes bottom portion  22 , which contains apertures for shafts  10  and  11  as described below. 
     Motor or electric power system  17  drives a gear assembly as described below. The motor  17  may be included in a motor housing if desirable. In such a case,  17  would depict the housing. The motor  17  is also electrically attached to batteries or another electrical power system housed in housing  1 . Such batteries or system power the motor  17  and are electrically connected to switch  4  for on/off operation of the motor. 
     Any batteries may optionally be of the rechargeable type and housing  1  may fit in a recharging station (not shown) for the batteries contained therein. 
     As is readily apparent the frangible opener  50  can also be powered by external electricity connected through a switch, such as  4 , to motor  17 . It is also understood that the switch  4  may be located on the handle  16  if desired with a suitable known electrical connection to batteries in housing  1  or the external electrical source. 
     The frangible opener  50  may also optionally include a light  17 A mounted on motor  17  and electrically connected to batteries in  1  and switch  4  to illuminate any frangible to be opened. 
     Motor  17  is connected through motor shaft  3  with enlarged section or crank  5  of first and second gear arrangements  6  and  7 . These gear arrangements  6  and  7  are keyed or toothed such that rotation of gear  6  counterclockwise causes rotation of the other gear  7  clockwise. Similarly, when gear  6  rotates clockwise gear  7  rotates counterclockwise. 
     Gear arrangement  6  is connected to first opener shaft  10  by hub  8 . This geared shaft  10  passes through bottom portion  22  of harness  2  and through washer connection  18 . Similarly, gear arrangement  7  is connected to second gear or opener shaft  11  by hub  9 , which also passes through bottom portion  22  of harness  2  and through second washer connector  19 . Shaft  10  terminates in first gripper end  12  while shaft  11  terminates in second gripper end  13 . 
     Gripper end  12  includes one side element  26  and opposing side element  28  (see  FIG. 4 ). These side elements are arranged in size so that a frangible, such as  23 , can fit between the side elements to rest against a base portion (not shown for gripper end  12 ,  29  for gripper end  13 ) of the gripper ends  12 ,  13 . 
     Similarly, gripper end  13  includes side elements  25  and  27  with base portion  29  there between. 
     The frangible opener  50  may be made from a variety of materials such as rigid plastic or polymer materials or various metals. Alternatively, a plurality of materials may be used for the frangible opener with some portions, such as the handle, being of plastic material, with other portions being metal. One constraint on the materials used is that such materials be light enough for the operator to hold and that the gearing, shafts and gripper be strong enough to break the frangible pin or element contained within the frangible  23 . 
     Cushion elements may also be used on the frangible opener  50  if desirable. Such cushion elements or padding may be used on the handle  16  and the switch  4 . If no handle is provided and the operator grips housing  1 , such cushion elements may also be provided on housing  1 . 
     Similarly, a tacky coating or material may be used to enhance cooperation between the frangible opener and the operator through use of such coating on handle  16 , housing  1  or switch  4 . Similarly tacky coating or material may be used between the gripper ends  25 ,  26 ,  27  and  28  and the (not shown) tubing to enhance cooperation. Such tacky coating or material could also be applied to base elements such as  29 . 
     The gearing  6 ,  7  and the motor  17  are such that when the motor rotates one direction, such as clockwise, gear  6  and associated shaft  10  will also rotate clockwise. However, gear  7  and associated shaft  11  will rotate counterclockwise. This movement bends the frangible opener in one direction. Thus, when gripper ends  26  and  25  move opposite each other, gripper ends  27  and  28  will move toward each other. Similarly when gripper ends  26  and  25  move toward each other the movement of  27  and  28  will be opposite each other and the frangible opener will bend in the opposite direction. This movement effectively snaps or breaks the frangible rigid U-shaped element or portion  43 . The motor can stop after rotation in one direction with the movement being reversed on the next switch contact or the motor can produce reciprocating motion of the shafts  10 ,  11  for each actuation. A limit switch or other sensor can be used to indicate the end of rotation in either direction. This can be used to trigger rotation in the opposite direction. 
       FIG. 5  illustrates the frangible opener in use with the disposable or bag set of  FIG. 1 . As shown, the frangible opener  50  can be used to open frangible  23  (inside conduit) in line  400  connected to bag  200 . The frangible opener  50  can also be used to open the frangibles  33  and  43  by reaching the frangibles with the frangible opener. In operation, and as a result of the gearing, the gear shafts  10  and  11  will each move in its first rotational direction to bend the frangible opener one direction and to snap or break one side of the U-shaped portion  43  inside the tubing  400 . The gearing will then cause each gear shaft  10  and  11  to move in a direction opposite from its first rotational direction to bend the frangible opener an opposite direction and to snap the other side of the U-shaped portion  43  to completely break the pin or stopper. The procedure can be repeated if needed. A similar process occurs with the alternative embodiments of  FIGS. 6-12 . In each of these embodiments, only the frangible  23  closer is shown for illustration purpose. It is in understood that the frangible closer will be inside tubing or conduit, such as  400 . 
     An alternate frangible opener  150  is shown in  FIGS. 6-9 . This embodiment includes a streamlined outer casing  116 , which forms a handle for the user or operator. Extending from the casing is opener shaft  110  having gripper end  112  and opener shaft  111  having gripper end  113 . The gripper ends can be similar to those described with respect to the embodiment of  FIGS. 3 and 4 . Each opener shaft  110  and  111  may optionally have cutout portion  115  (not shown for opener shaft  111 ) to minimize the weight of the overall opener  150 . 
       FIG. 7  illustrates the opener of  FIG. 6  without the outer casing  116 . Frame support  114  carries optional batteries  101  along with a optional LED light display  118 . The motor is illustrated at  117 . Switch  104  can be slidably moved by the operator to connect the motor to the power source for selective operation. Alternatively, the switch may be depressed for example, towards motor  117  to make such a connection. A harness or frame  120  is also provided to support the outer casing  116  and to protect and support the crank and gear arrangement described below. The cross-wise portion  122  of the frame support  120  supports the gear shafts  110  and  111  through a bushing or bearing as described with respect to the embodiment of  FIGS. 3 and 4 . In this embodiment, motor  117  engages crank  119  for providing rotational movement through linkage  123  and pin  121  to gear wheel  107  and through enlarged shaft portion  109  to gear shaft  111 . The engagement between the motor  117  and the crank  119  may be through a gear head. 
     Follower gear  106  rotates along with gear  107  to impart rotational movement, through enlarged portion  108 , to gear shaft  110 . 
     Similar to the embodiment of  FIGS. 3 and 4 , gear  107  rotates in one direction causing gear  106  to rotate in the opposite direction. This imparts opposite rotational movement to opener shaft  110  as compared to that of opener shaft  111  and causes one arm of gripper ends  112  and  113  to move toward each other while the other arm moves toward each other. 
     In operation, an operator will slide switch  104  to provide power to motor  117  to bring about rotational movement of crank  119 , and gear shaft  107 . Rotation of  107  will cause opposite direction rotation of opener shafts  110  and  111 . The motor  117  can be reciprocal which will cause reciprocal bending of frangible  23  to break the pin contained therein. Limit switches or sensors sensing the end of the rotation range may be used to trigger the reciprocal rotation or the end of rotation. 
     As with the embodiment of  FIGS. 3 and 4 , the frangible opener of  FIGS. 6 through 9  can also be operated on electric current. In addition, the batteries, if used, can be replaceable or rechargeable using a recharging holder (not shown). 
       FIGS. 10-12  illustrate a manually activated frangible opener that can be operated without motor assistance. 
     This embodiment includes a base plate  214 . Fixed, with respect to the base plate  214  attached to the base through pin  216  is handle  218 . A moveable handle  252  having gripper opening  253  is also attached to base plate  214  either through pin  216  or another, not shown, pin. 
     Movement of handle  252  also brings about movement of driver gear  206 , which is attached to a part of the handle  252 . Driver gear  206  imparts rotational movement to follow gear  209  (not shown, but see  FIG. 13 ) and through follower gear  209  to crank  219 . Crank  219  is connected through pin  243  to connecting link  220 . Linkage  210  and  211  are connected through pin  215  to link or linkage  220  and such pin  215  also connects  210 ,  211  and  220  to base plate  214 . Toggle  244  contains an upper toggle portion  245  that is rotatable with respect to the lower toggle portion  246 . Upper toggle portion  245  includes a clip  213  for engaging one end of a frangible such as  23 . Lower toggle portion  246  also includes a clip  212 , for engaging another end of the frangible  23 . 
     Toggle  244  is attached to base plate by a pin (not shown in this embodiment of  FIG. 12 ). This pin permits upper toggle portion  245  to pivot with respect to lower toggle portion  246 . 
     In this embodiment, as with a number of the other embodiments, only the frangible  23  is shown to indicate its breakage. It is understood that the frangible opener can be inside tubing, such as  400 . 
     In operation the tubing containing frangible open  23  is inserted in clips  212  and  213 . The frangible open  250  is in the neutral position of  FIG. 10 . Movement of handle  252  also moves the gear  206 , crank  219  and imparts movement of toggle portion  245  with respect to toggle portion  246 , through linkage  210 ,  211  and  220 . This is shown in  FIG. 11 . Further movement of handle  252  results in the movement of toggle portion  245  with respect to  246  shown in  FIG. 12 . 
       FIG. 13  is embodiment similar to  FIGS. 10-12 , except that rotary element  229  is moved via handle  240  (or an optional motor) to move drive gear  236 , follower gear  237 , crank  239  and linkages  227 ,  230  and  221 , upper toggle portion  223  (with frangible holding clips  233 ) and lower toggle portion  222  (with frangible holding clip  232 ). The frangible opener of this Figure can be held by handle  228  attached to base plate  224 . 
     The operation of the embodiment of  FIG. 13  is very similar to that of  FIGS. 10-12 , except that the initial movement of driver gear  236  is initiated by the rotating element  229 . A limit switch or sensor may optionally be provided with this embodiment to trigger reciprocal motion or end of motion. 
     An alternative embodiment is shown in  FIGS. 14-16 . 
     In this embodiment handle  317  is connected to linear actuator or linear solenoid through pivot pin  340 . Drive rod or linkage  306  is attached to the linear actuator  329  through passage  307 . Drive rod cooperates with drive gear  309 , which in turn cooperates with follower gear  319 . Upper toggle portion  313  having clips  332  for a frangible such as  23  is attached to follower gear  319 . Lower toggle portion  312  having frangible clips  333  is attached to drive gear  309 . 
     In operation, movement or rotation of handle  317  imparts rotation to linear actuator  329 . Rotation of crank  329  moves drive rod or drive linkage  306  in one direction to rotate drive gear  309 . Rotation of drive gear counter clockwise moves toggle follower gear in the opposite direction. This moves upper toggle  313  with respect to  312 . Similarly, movement of linkage  306  and drive gear  309  in the opposite direction moves the upper and lower toggle portions  313  and  312  in opposite directions. Reverse or opposite linear motion acting on  306  can be achieved by opposite rotation of crank  329 . Although crank  329  is described as being rotated by handle  317 , it can also be rotated by through an electrical connection. 
     Optionally, in an electrical embodiment, sensors or limit switches  350  and  351  may be provided on an outer housing, not shown, to provide a signal to a controller (not shown) to determine when the linear actuator should change direction or stop. The sensors or switches may sense the movement of the toggles  312 ,  313  as shown or movement of the linear actuator. 
     The frangible openers of the instant invention, are light in weight for the operator to hold. As the only manual motion may be the push of a switch, the opener also minimizes wrist and hand motion that may result in repetitive strain injury. In a blood processing lab utilizing the centrifuge of  FIG. 5  and the bag set of  FIG. 1 , it is anticipated that single operator may need to open hundreds of frangibles in a single day.