Abstract:
A restraining device for a tubing connector assembly can include a resilient member having a generally U-shape with forked ends that curve toward each other. Each forked end can have a recess between tines thereof. Each recess can have a blind end. The resilient member can have a bend provided with an engagement bump. The engagement bump and forked ends can be aligned such that the engagement bump coincides with a line joining the blind ends. When a cylindrical connector assembly tube is placed in the recesses, the engagement bump is urged against a side of the connector assembly to thereby prevent inadvertent disconnection.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims the benefit of U.S. Provisional Application No. 61/255,453, filed Oct. 27, 2009, and U.S. Provisional Application No. 61/316,503, filed Mar. 23, 2010, both of which are hereby incorporated by reference herein in their entireties. 
     
    
     FIELD 
       [0002]    This present disclosure relates generally to fluid line connections, and, more particularly, to restraining and safety devices for fluid lines and tubing connections, such as those employed in medical treatment devices. 
       BACKGROUND 
       [0003]    Tubing connections are commonly used in medical treatment systems, chemical processing plants, pharmaceutical plants, laboratories, manufacturing systems, hydraulic systems, etc. A common class of connectors mates by mutually rotating parts of the connectors and/or by pushing the connectors together. A common type of connector is a luer-type connector, which can include a relatively long male element that fits tightly into a channel of a female element. 
         [0004]    Originally, luer-type connectors were merely pushed together in order to make a connection. Over time, the connectors evolved to include threaded collars so as to make it more difficult for the connections to arbitrarily disconnect. The threaded collars thus may increase the reliability of the luer-type connections. However, in some applications (e.g., extracorporeal blood treatment systems), it may be desirable to mitigate even minute levels of risk that may be caused by disconnection of the luer-type connections. Accordingly, there is a need in the art for simple and inexpensive ways to increase the reliability of connectors for fluid-carrying vessels. In particular, such a need is felt in the area of tubing systems used in medical treatment devices. It may also be desirable to enhance the security of luer-type connectors without altering the familiar features of their design or usability. 
       SUMMARY 
       [0005]    Various restraining mechanisms and methods for preventing the accidental decoupling of connectors are disclosed herein. A generally U-shaped resilient member can have ends with openings therein for receiving tubing attached to the connectors. The ends of the resilient member can be arranged so as to apply an urging force to opposite ends of the connectors to prevent separation of the connectors. Other portions of the resilient member, such as a centrally located bend with an engagement bump, can interact with a portion of the connectors to further prevent inadvertent connector separation. The various mechanisms and methods are particularly applicable to luer-type connectors. However, the mechanisms and methods can also be used with other types of connectors or connections according to one or more contemplated embodiments. 
         [0006]    In embodiments, a restraining device can include a resilient member having a generally U-shape with forked ends that curve toward each other. Each forked end can have a recess between tines thereof. Each recess can have a blind end. The resilient member can have a bend provided with an engagement bump. The engagement bump and forked ends can be aligned such that the engagement bump coincides with a line joining the blind ends. When a cylindrical connector assembly tube is placed in the recesses, the engagement bump is urged against a side of the connector assembly. 
         [0007]    In embodiments, a restraining member for a connector assembly can include a forked first end having a first recess between tines thereof and a closed second end having an opening therein. The first recess can be sized and shaped so as to accept a first tubing connected to one end of the connector assembly. The second end can be sized and shaped so as to accept a second tubing connected to another end of the connector assembly. The restraining member can have a bend with an engagement bump arranged between the first and second ends. The bend can be arranged such that, when the first and second ends abut against respective first and second ends of the connector assembly, the engagement bump interacts with a knurled attachment member so as to inhibit rotation thereof. 
         [0008]    In embodiments, a tubing set can include a restraining member, a tubing line, and a connector. The restraining member can include a forked first end having a first recess between tines thereof, a closed second end having an opening therein, and a bend with an engagement bump arranged between the first and second ends. The tubing line can pass through the opening in the closed second end of the restraining member. The connector can be attached to an end of the tubing line. 
         [0009]    In embodiments, a restraining member for a connector assembly can include first and second ends with a bridge connecting the first and second ends. The first end can have a first U-shaped recess therein. The first recess can be sized and shaped so as to accept a first tubing connected to one end of the connector assembly. The second end can have an opening therein. The second end can be sized and shaped so as to accept a second tubing connected to an other end of the connector assembly. The bridge can have a bend therein with an engagement bump. The restraining member can also have an attachment portion configured to secure the restraining member to the second tubing such that the restraining member cannot be used with another second tubing. 
         [0010]    In embodiments, a connector assembly for first and second tubes can have mating connectors thereon. One of the mating connectors can have a locking collar that locks the other of the mating connectors. A restraining member for the connector assembly can include first and second ends and a flexible bridge portion. The first and second ends can be shaped to capture and position first and second mating connector parts attached to the first and second tubes, respectively. The flexible bridge portion can connect the first and second ends. The flexible bridge portion can be shaped such that when the first and second mating connector parts are connected, the first and second ends are urged together thereby urging the first and second mating connectors together. The flexible bridge portion can have an engagement element with an edge that captures and immobilizes the locking collar. 
         [0011]    In embodiments, a restraining device can include a resilient member having a generally U-shape with forked ends that curve toward each other. Each forked end can have a recess between tines thereof. The forked ends can have facing bowl shapes. The resilient member can have a bend provided with an engagement bump. The engagement bump and the forked ends can be aligned such that the engagement bump coincides with a line joining the facing bowl shapes. When a cylindrical connector assembly tube is placed in the recesses, the engagement bump is urged against a side of the connector assembly. 
         [0012]    In embodiments, a device is configured to urge mating connectors together while simultaneously urging an engagement member into at least one of the mating connectors, such that, by the urging an engagement member, the at least one of the mating connectors is prevented from rotating. 
         [0013]    Objects and advantages of embodiments of the present disclosure will become apparent from the following description when considered in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0014]    Embodiments will hereinafter be described with reference to the accompanying drawings, wherein like reference numerals represent like elements. The accompanying drawings have not necessarily been drawn to scale. Any dimensions illustrated in the accompanying graphs and figures are for illustration purposes only and may not represent actual or preferred dimensions. Where applicable, some features may not be illustrated to assist in the description of underlying features. 
           [0015]      FIG. 1  is a side view of a restraining clip according to embodiments of the disclosed subject matter. 
           [0016]      FIG. 2  is a section view C-C of the restraining clip taken along a plane parallel to the view of  FIG. 1 . 
           [0017]      FIG. 3  is an oblique projection of the restraining clip of  FIG. 1 . 
           [0018]      FIG. 4  is a fragmentary section view A-A of the restraining clip of  FIG. 1  taken along plane perpendicular to the view of  FIG. 1 . 
           [0019]      FIG. 5  is an end elevation view of the restraining clip of  FIG. 1 . 
           [0020]      FIG. 6  is a plan view of the restraining clip of  FIG. 1 . 
           [0021]      FIG. 7  shows the restraining clip of  FIG. 1  attached to interconnected tubing ends according to embodiments of the disclosed subject matter. 
           [0022]      FIG. 8  is an image of an actual embodiment similar to that of  FIG. 7 . 
           [0023]      FIG. 9  shows a scissor-type restraining clip according to embodiments of the disclosed subject matter. 
           [0024]      FIGS. 10 and 12  are oblique projection views of another restraining clip with a leash portion according to embodiments of the disclosed subject matter. 
           [0025]      FIG. 11  is an end elevation view of the restraining clip of  FIG. 10 . 
           [0026]      FIG. 13  is an oblique projection view of the restraining clip with leash portion of  FIG. 11  installed on a tubing line, according to embodiments of the disclosed subject matter. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    Various mechanisms and methods for preventing the accidental decoupling of connectors are disclosed herein. In embodiments, a restraining member to prevent disconnection can apply a biasing force against opposite ends of the connector assembly, thereby urging the connectors together and against separation. The restraining member may include openings and/or recesses through which tubing lines connected to the connector assembly may pass. In embodiments, additional anti-separation components may also be provided in the restraining member. For example, the restraining member may include a protrusion, recess, or other appropriately arranged portion to interact with a portion of the connector assembly, e.g., a rotatable portion of the connector assembly to prevent rotation thereof. 
         [0028]    In  FIGS. 1-8 , an embodiment of a restraining member for a tubing connector assembly is shown. A monolithic member forms a restraining clip  100 , which can serve as a fluid line safety device for inhibiting inadvertent disconnection of a connector assembly. The restraining clip  100  can have an undulating shape with curved forked ends  104  and a slot or recess  120  between the tines of the forked ends. The restraining clip  100  may be formed of a resilient material, such as a polymer. However, other materials for restraining clip  100  are also possible according to one or more contemplated embodiments. 
         [0029]    The shape of the forked ends  104  permits the restraining clip  100  to accommodate the ends of interconnected tube segments, as illustrated in  FIGS. 7-8 . The forked ends  104  may be connected together by an undulating bridge, which includes an inwardly arching portion  114 . The inwardly arching portion  114  has a knife edge bump  110  that engages a knurled attachment member  202  of the connection assembly. The interaction between the bump  110  and the attachment member  202  may prevent, or at least inhibit, it from rotating. A reinforcement bulge  102  ensures that the forked end  104  maintains a curved shape such that the forked ends  104  pushes against the connector ends  204  and  206  while maintaining contact of the knife edge bump  110  with the knurled attachment member  202 . 
         [0030]    In some luer connectors, the male luer  206  may have a rotating member  206 . The female luer  204  may have a shape, for example, with flats or recesses, which interacts with the surface of the forked end  104  so as to keep it from rotating. Alternatively, or additionally, the size and shape of slot  120  may be chosen so as to grip an attached tube  212  from opposing sides. For example, the slot  120  may have a progressively narrowing shape. Portions indicated at  112  and  116  may stiffen the overall structure of the restraining clip  100 . 
         [0031]    Opposing surfaces of the opposite forked ends  104  may be provided with recesses into which the connector ends  204  and  206  fit. The size of the restraining clip  100  may be chosen such that an urging force is applied thereby forcing the connector ends  204 ,  206  together even when they are fully engaged. The photo of  FIG. 8  shows how the restraining clip  100  can be deformed when in position to hold the connectors—in the illustrated example, luer connectors—together. The deformation can produce a restoring force that urges the parts together, even when the connectors are otherwise fully connected. The curved shape of the forked ends  104  also help to provide a force urging the knurls of attachment member  202  against knife edge bump  110  while the forked ends  104  are urged together by the restoring force of the restraining clip  100 . 
         [0032]    To use the restraining clip  100 , the forked ends  104  are spread apart. This can be done with two hands or with one. For example, to apply the restraining clip  100  to a connection assembly using one hand, two fingers of the left or right hand are inserted into narrow loops  140  and squeezed together, thereby actuating the forked ends  104  away from each other. The restraining clip  100  is then placed into position about the connection assembly with each forked end  104  adjacent to a respective connector end of the connection assembly, at which time the narrow loops  140  are released. By virtue of the resiliency of the restraining clip  100 , a biasing force is thus applied to the ends of the connectors of the connection assembly thereby urging the connectors together, as shown in  FIG. 8 . Exemplary dimensions for the restraining clip are shown in  FIGS. 2 ,  4 , and  5 . However, such dimensions are for illustration purposes only and are not limiting of the sizes and shapes for embodiments of the restraining clip according to the present disclosure. 
         [0033]      FIG. 9  shows an alternative embodiment  300  based on a scissor-type mechanism. An elastic band  308  generates a force to urge two curved forked ends  302  together. A knife edge bump  310  on a resiliently deformable circular member  304  is urged against the knurled male luer cap  202 . The halves of the scissor mechanism and the circular member  304  are retained by a hinge pin  306 . Handles  325  permit the device to be engaged and released with a single hand by pinching the handles  325  together. 
         [0034]    In some applications, such as medical treatment applications, it may be desirable to use a new restraining clip for each new connection so as to insure reliability of the new connection that may otherwise be compromised by reuse of the restraining clip. To prevent reuse of the restraining clip, the restraining clip may be semi-permanently or permanently coupled with a single-use or disposable tubing line. Discarding the used tubing line would also discard the used restraining clip in favor of a new tubing line with a new restraining clip. 
         [0035]    Referring to  FIGS. 10-13 , an alternative embodiment for a restraining clip according to the present disclosure is shown, which may be used in the above-described applications. Restraining clip  100   a  is similar to the restraining clip  100  illustrated in  FIGS. 1-8 ; however, while one end  104  of restraining clip  100   a  retains the forked configuration with slot  120 , the other end  104   a  has a closed opening  120   a.  For example, tines of one of the forked ends  104  in  FIGS. 1-8  can be joined together by an attachment portion to enclose one end of opening  120   a.    
         [0036]    The recess  120   a  may be sized and shaped so as to accommodate a tubing line therethrough. The recess  120   a  may also be sized and shaped to prevent connector  204  (or  206 ) from passing therethrough. When installed on a tubing line  212 , the connector  204  (or  206 ) would prevent the restraining clip  100   a  from being removed from the tubing line  212 . To assemble the tubing line with the restraining clip, the tubing line  212  may be passed through opening  120   a  of the restraining clip  100   a  prior to installing the connector  204  (or  206 ) on the tubing line. End  104   a  thus forms a leash that attaches or secures the restraining clip  100   a  to one of the tubing lines  212 , such that the restraining clip  100   a  can only be used with that tubing line. Replacement of the tubing line necessarily requires replacement of the restraining clip  100   a.  In an example, tubing line  212  is a blood tubing line for use in extracorporeal blood tubing sets. 
         [0037]    Of course, other configurations for coupling the restraining clip to the tubing line such that both the tubing line and the restraining clip must be replaced together are also possible according to one or more contemplated embodiments. For example, the restraining clip could include a separate leash portion, either integrally formed as a part of the restraining clip or as a separate piece, which secures the restraining clip to a particular tubing line. In another example, the restraining clip leash portion may be formed as part of one of the connectors or permanently attached to one of the connectors of the connector assembly. 
         [0038]    In any of the embodiments disclosed herein, the type of connector could be a luer-type connector or any other connector which relies on mutually rotatable parts on the connecting elements and/or which slide apart to disconnect. Also, although inline connectors are shown for purposes of illustration, the disconnect protection features shown can be applied to other types of connectors, such as, but not limited to connectors forming parts of junctions, components such as valves or filters, or others. 
         [0039]    Features of the disclosed embodiments may be combined, rearranged, omitted, etc., within the scope of the present disclosure to produce additional embodiments. Furthermore, certain features may sometimes be used to advantage without a corresponding use of other features. 
         [0040]    It is, thus, apparent that there is provided, in accordance with the present disclosure, fluid line safety devices, mechanisms, and methods. Many alternatives, modifications, and variations are enabled by the present disclosure. While specific embodiments have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles. Accordingly, Applicants intend to embrace all such alternatives, modifications, equivalents, and variations that are within the spirit and scope of the present invention.