Abstract:
A device is provided for ensuring the sterile integrity of two separate fluid pathways during interconnection of the two pathways with a two-part connector assembly. The two-part connector assembly is of the type which comprises a male portion and a female portion, each portion initially having a port covered and protected by a peel-away strip. The device comprises a base assembly, a connector clamp assembly mounted to the base assembly and configured for securing the two-part connector assembly in position for interconnection of the male and female portions, and a strip withdrawal assembly mounted to the base assembly and configured for simultaneous withdrawal of the peel-away strips from the ports of the male and female portions.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a national phase of International Application PCT/US10/030191, filed Apr. 7, 2010, which claims priority under 35 USC §119 to U.S. Provisional Application No. 61/168,286, filed Apr. 10, 2009, each of which is herein incorporated by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The invention generally relates to technical applications involving the transfer of fluids under sterile conditions, and, more particularly, to devices which ensure the sterile integrity of connectors of fluid pathways during the connection thereof. 
     BACKGROUND 
     Sanitary and sterile piping, and fluid transfer systems, are essential to many industries, particularly medical, pharmaceutical, biotechnology, etc. In transferring fluid products for further processing or storage, bulk fluid transfer pathways and connections must be established and maintained. These often involve the realignment or configuration of sanitary piping/tubing systems, which comprise multiple manual and automated valves, including the associated temperature and pressure transmitters, regulators, filters, steam traps, etc. Ensuring the required levels of sterility of the fluid transfer pathways in these systems is thus critical, and often problematic. 
     In more recent years, disposable specialized fluid transfer systems have been introduced which permit quick connections and disconnections of fluid transfer tubing or piping, most of which is formed of plastic. One such system for sterile processes employs a two-part connector known as the KLEENPAK™ HT Connector, available from Pall Corporation Life Sciences (see  FIGS. 1A and 1B ). This connector permits a dry connection to be made between two separate fluid pathways, while maintaining the sterile integrity of both. The connector consists of male and female portions, each portion having a vented peel-away strip that protects the port, or pathway opening, and maintains the sterility of the fluid pathways before the two portions are connected. The vented peel-away strips should be simultaneously removed immediately before the two connector portions are engaged to form a sealed, locked connection. 
     However, even with newer connection systems such as the KLEENPAK™ HT Connector, manual removal of the peel-away strips and positive engagement of the two connector portions is still required. The normally field-executed manual process provides an opportunity for operator variations, incomplete assembly of the male and female portions, sideways withdrawal of the vented strips, partial withdrawal of the vented strips, and incomplete insertion of the male portion into the female portion, all of which are detrimental to the operation of the connection assembly, and which can lead to the potential breach of sterile integrity. For example, if the vented strips are not simultaneously and evenly withdrawn from the male and female portions, there is the potential that the exposed, and potentially contaminated, outer surface of one of the vented strips may contact and contaminate the exposed port of the other connector portion. This possibility, and the potential harmful results which could follow, have led to careful scrutiny by various regulatory agencies. 
     What is needed, therefore, is a consistently repeatable and validated process which increases the likelihood of maintaining the required sterility. 
     Various features and aspects of the invention will become apparent upon review of the detailed description set forth below when taken in conjunction with the accompanying drawing figures, which are briefly described as follows. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a device for ensuring the sterile integrity of two separate fluid pathways during interconnection of the two pathways with a two-part connector assembly comprising male and female portions. The exemplary KLEENPAK™ HT Connector is supplied with a peel-away strip covering and protecting the port of each portion. One embodiment of the device of the present invention includes a base assembly, a connector clamp assembly mounted to the base assembly and configured for securing the two-part connector assembly in position for interconnection of the male and female portions, and a strip withdrawal assembly mounted to the base assembly and configured for simultaneous withdrawal of the peel-away strips from the ports of the male and female portions. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a schematic illustrating the configuration of the KLEENPAK™ HT Connector, including the male and female portions, and the vented peel-away strips. 
         FIG. 1B  illustrates the KLEENPAK™ HT Connector, with the male and female portions connected, but not fully engaged. 
         FIG. 2  is a left front perspective view of the device of the present invention. 
         FIG. 3  is a right front perspective view of the device of the present invention. 
         FIG. 4  is a rear perspective view of the device of the present invention. 
         FIG. 5  is a rear elevational view of the device of the present invention. 
         FIG. 6  is a close-up expanded view of the lever and ratchet assembly of  FIG. 5 . 
         FIG. 7  is a schematic depicting the operation of the device of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Certain exemplary embodiments of the present invention are described below and illustrated in the accompanying figures. The embodiments described are only for purposes of illustrating the present invention and should not be interpreted as limiting the scope of the invention, which, of course, is limited only by the claims below. Other embodiments of the invention, and certain modifications and improvements of the described embodiments, will occur to those skilled in the art, and all such alternate embodiments, modifications and improvements are within the scope of the present invention. 
     The present invention is directed to a device which provides for a sterile process connection to be affected, using a commercially available and disposable connector, in a manner that requires all operator variability to be eliminated for consistent and repeatable execution, and which addresses the problems described above. For field execution of the KLEENPAK™ HT Connector (the “Connector”), the present invention: (1) provides a high level of security and protection from damage for the relatively fragile connector because the device is a stable and robust holder; (2) ensures that the male and female portions are fully snapped together before actuation; i.e., they will not insert into the cradle of the device unless properly assembled; (3) ensures simultaneous straight line pull of both vented strips for field execution of the connector; (4) ensures full withdrawal of the vented strips (the ratchet assembly described herein prevents premature return of the withdrawal lever); and, (5) ensures that the final step in the connection process results in a fully engaged connector (complete insertion of the male portion into the female portion) by use of an engagement gauge. 
     Turning now to  FIGS. 1A and 1B , performing a field connection of a disposable connector  10 , such as the KLEENPAK™ HT Connector, requires several steps: (1) removal of the protective end caps (not shown) from the male  12  and female  18  portions; (2) alignment of the male  12  and female  18  portions with the peel-away strips S facing each other, by pressing the two portions together until they snap tightly together ( FIG. 1B ); (3) withdrawal of the strips S simultaneously in a smooth, continuous motion; (4) rotation one partial turn of the thumb rest  12   a  on the male portion  12 ; and, (5) pushing of male portion  12  into the female portion  18  for full engagement. While this procedure takes only a few seconds, step (3) is critical and must be performed consistently to ensure sterile integrity each time that a field connection is performed. That is, manual withdrawal of the strips does not inherently guarantee successful execution of this step, as the pair of strips must be withdrawn from the male and female portions together completely and evenly, straight radially outward, and with no differential motion between the two strips. Further, the male and female portions must be fully engaged to ensure “crevice-free” functionality, and thus, sterility of the interconnected pathways. 
     Referring now to  FIGS. 2 through 5 , one exemplary embodiment of the device, designated generally as  100 , is shown. The device  100  comprises a base assembly  110 , a connector clamp assembly  120 , a strip removal assembly  130 , and an optional engagement gauge  140 . The base assembly  110  comprises a generally planar base  112 , upstanding support walls  114 ,  116 , and a cradle  118 . As best shown in  FIGS. 3 and 7 , a slot  118   a  is formed through the cradle  118  through which the vented peel-away strips S will extend when the connector  10  is placed in the cradle  118 . The connector clamp assembly  120  is mounted on one wall  116  and comprises a mounting arm  122  and toggle clamp  124  mechanism, the toggle clamp mechanism  124  being pivotally connected to the mounting arm  122 . The mounting arm  122  may be mounted on the wall  116  by any conventional means of attachment, including fasteners, adhesives, etc. As will be appreciated by those skilled in the art, the components of the device  100  described herein may be formed from a variety of materials that sufficiently provide the required functional characteristics of the device  100 . As shown in  FIGS. 3 and 7 , the toggle clamp  124  comprises a positive locking mechanism  126 , which ensures that the clamp  124  remains in a closed, locked position with the arcuate end  124   a  ( FIG. 2 ) of the clamp  124  against the connector  10  barrel (the larger diameter section of the connector) once the positive locking mechanism  126  is pivoted inwardly toward the connector  100 . Those skilled in the art will appreciate that there are a number of mechanical assembly combinations which may form suitable pivotal locking mechanisms. 
     As shown in  FIGS. 3 ,  6 ,  8 , and  10 , a strip removal assembly  130  is slidably mounted on the other wall  114  in vertical elongate slots  114   a . The strip removal assembly  130  includes a slidable front mounting plate  131  to which a first clamping portion  132  is affixed. Serrated teeth  132   a  are formed on the face of the first clamping portion  132 . A second clamping portion  134  is pivotally connected to the first clamping portion  132  for gripping engagement therewith. The second clamp portion  134  portion also has serrated teeth  134   a , and a positive locking mechanism  133 , which ensures that the second clamp  134  remains in a closed locked position so that the serrated teeth  134   a  of the second clamp portion  134  positively engage the serrated teeth  132   a  of the first clamp portion  132  when the positive locking mechanism  133  is pivoted upwardly and inwardly. In the closed, locked position, the positive locking mechanism  133  causes the serrated teeth  132   a ,  134   a  to firmly grip the pair of vented peel-away strips S. 
     Referring to  FIGS. 3 and 4 , with a connector  10  secured in the cradle  118 , with the strips S extending downwardly through the slot  118   a , the positive locking mechanism  133  is closed and locked in position, whereby the pair of strips S are positively held for subsequent withdrawal by the serrated teeth  132   a ,  134   a . Turning to  FIGS. 4 through 6 , the back side of the strip removal assembly  130  is shown. A slidable rear mounting plate  135  is interconnected to the slidable front mounting plate  131  through the vertical slots  114   a  (see enlarged view in  FIG. 6 ). A withdrawal lever  136  is mounted with one end  136   a  pivotally affixed to the rear of the wall  114 . A guide pin  135   a  projects outwardly from the rear mounting plate  135  to engage an elongate slot  136   b  formed in the lever  136 . The length of the slot  136   b  is sufficient to accommodate the movement of the pin  135   a  when the lever  136  is fully depressed downwardly to cause the strip withdrawal assembly  130  to simultaneously move downwardly, withdrawing the strips S. 
     As shown in  FIG. 6 , a ratchet mechanism  138 , comprising a ratchet pawl  138   a  and a spring  138   b , is configured to engage the serrated teeth  135   b  along the inner edge of the rear mounting plate  135 . This is accomplished by the pivotal mounting of the ratchet pawl  138   a , which is attached to the extension spring  138   b . As the lever  136  is depressed downwardly, the rear mounting plate  135  slides downwardly in the vertical slots  114   a , with the teeth  135   b  causing the ratchet pawl  138   a  to pivot downwardly. As will be appreciated, the spring  138   b  biases the ratchet pawl  138   a  upwardly against the teeth  135   b  so that the movement of the lever cannot be prematurely reversed to return to the “home” position until the complete downward withdrawal stroke is performed. Thus, with the toggle clamp assembly  133  in a closed position, operation of the lever  136  ensures that the vented peel-away strips S are both simultaneously withdrawn in a straight line pull. 
     Following withdrawal of the strips S, the user rotates the thumb rest  12   a  on the male portion  12  of the connector  10  one partial turn and pushes the male portion  12  into full engagement with the female portion  18 . As best shown in  FIGS. 2 and 4 , the device  100  further comprises an engagement gauge  140 . The engagement gauge  140  has an arm  141 , which is pivotally mounted to a wall  116 . A notch  143  is formed in one side of the arm  141 , the notch  143  corresponding in dimension (diameter) to the diameter of the male portion  12 ; i.e., that diameter of the male portion  12  which mates with the tubing to form a fluid pathway. The engagement gauge  140  ensures that the male and female portions of the connector are fully engaged. If fully engaged, when the engagement gauge  140  is pivoted upwardly, it will engage the male portion  12  behind the flange  12   b  (see  FIG. 1B ). If the male and female portions are not fully engaged, then the engagement gauge  140  cannot engage the male portion  12 . 
     Turning lastly to  FIG. 7 , in view of  FIGS. 1A through 6 , operation of the device is schematically illustrated. First (Step  1 ), the connector assembly (male and female portions) are placed in the cradle, with the vented strips S extending through the slot to position the strips S between the serrated teeth  132   a ,  134   a . The positive locking mechanism  126  is then pivoted closed to secure the connector in place (Step  2 ). Pivotal toggle  135  is then closed, capturing the pair of vented strips S between the serrated teeth  132   a    134   a  of the strip removal assembly  130  (Step  3 ). With the clamp portions engaged, the lever  136  is depressed downwardly (Step  4 ) to simultaneously pull the strips S downwardly from between the male  12  and female  18  portions of the connector. The connector is next actuated by manually twisting the thumbrest  12   a  of the male portion  12  a partial turn and pushing it fully into the female portion  18  (Step  5 ). Lastly, the engagement gauge  140  is pivoted upwardly into position to encompass the male portion flange  12   a  (Step  6 ). The engagement guide  140  will not move into position against the flange unless the connector portions are in 100 percent engagement. 
     The invention has been described herein in terms of several embodiments and constructions that are considered by the inventor to represent the best mode of carrying out the invention. It will be understood by those skilled in the art that various modifications, variations, changes and additions can be made to the illustrated embodiments without departing from the spirit and scope of the invention. These and other modifications are possible and within the scope of the invention as set forth in the claims.