Abstract:
The present application describes devices that use various features to prevent the disconnection of connectors used in medical treatments. For example embodiments prevent disconnection of luer connectors that are incompletely mated.

Description:
FIELD OF THE INVENTION  
       [0001]    The invention relates to fluid line connections and particularly to tubing connections such as those that are frequently employed in medical treatment devices. 
       BACKGROUND  
       [0002]    Tubing connections are commonly used medical treatment systems, chemical processing plants, pharmaceutical plants, laboratories, etc. A common class of connectors mate by mutually rotating parts of the connectors, by pushing them together, or both. One common type of connector is a luer connector which includes a relatively long male element which fits tightly in a channel of a female element. In 1970s luers were merely pushed together to make a connection. Later, threaded collars were added to make it harder for the luer connectors to come apart. Even though the threaded collar increases the reliability of the connection, in some applications, such as extracorporeal blood treatment systems, it is desirable to address even minute levels of risk, if possible. There is a need in the art for simple and inexpensive ways to increase the reliability of connectors for fluid-carrying vessels and particularly, this need is felt in the area of tubing systems used in medical treatment devices. In particular, it would be desirable to enhance the security of luer-type connectors without altering the familiar features of their design or usability. 
       SUMMARY  
       [0003]    Various mechanisms and methods for preventing the accidental decoupling of connectors are provided. All are particularly adapted for use with luer-type connectors. 
         [0004]    According to an embodiment, a connector protection device operates with a connector having first and second mating parts which are held together by a non-frictional engagement device. The device includes a first connector and a second connector which are configured to mate to define a continuous flow path between them. A securing element prevents the first and second connectors disconnecting by at least one non-frictional mechanism. The securing element is movable with respect to at least one of the first and second connectors to allow the first and second connectors to disconnect. A disconnection prevention member extends between the first and second connectors and is effective to prevent at least one of a movement of the securing element and a separation of the first and second connectors such that the first and second connectors are prevented from disconnecting. In one variation, the first and second connectors form a luer-type connector and the securing element includes a threaded barrel on one of the first and second connectors that engages a threading element on the other of the first and second connectors. In a variation of the latter embodiment, the disconnection prevention member prevents the barrel from rotating relative to the other of the first and second connectors. 
         [0005]    According to another embodiment, the connector protection device prevents the disengagement of two mating connectors which have a locking component that maintains the connection between the mating connectors by non-frictional means. For example, the two connectors may be screwed together or clamped together. Clamps and screws provide a positive engagement between the mating connectors. Whereas a luer connector without a locking thread portion, such as the prior art luer connectors lacking a locking device, relied on frictional engagement between the male and female luer to maintain the connection between the male and female connector components. In the embodiment, a protector helps to ensure that the connectors do not come apart either by backing the connector element up or by preventing it from disengaging and thereby permitting the connectors from coming apart. So, for example, if the connectors are luer connectors and the locking component is a threaded barrel, the connector protection device could serve the function defined by either preventing the barrel from rotating or by preventing the male and female luers from separating if the threaded barrel fails. Thus, in the embodiment, the connection protection device is one of: (1) a device that prevents the decoupling of the connectors such that failure of the connection is either prevented or inhibited by holding the connectors together and (2) a device that locks the locking component, thereby preventing it from failing to do its job. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]    The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate exemplary embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. 
           [0007]      FIG. 1  shows a typical luer-type inline connector. 
           [0008]      FIGS. 2A and 2B  show a flexible disconnect protector design which prevents the luer-type connector of  FIG. 1  from disconnecting. 
           [0009]      FIG. 3  shows the disconnect protector of  FIGS. 2A and 2B  positioned to prevent the disconnection of a luer-type connector. 
           [0010]      FIG. 4  illustrates a step and a configuration used to remove or install the disconnect protector of  FIGS. 2A and 2B  on the luer-type connector. 
           [0011]      FIG. 5  shows a position in which the disconnect protector can be placed to disconnect the luer-type connector. 
           [0012]      FIG. 6  shows a modified luer-type connector with wings on a rotating part that engage with another disconnect protector. 
           [0013]      FIGS. 7A through 7C  show additional embodiments of disconnect protector. 
           [0014]      FIG. 8  shows the embodiment of  FIG. 7A  in use with the luer-type connector of  FIG. 6 . 
           [0015]      FIGS. 9A through 9C  show various disconnect protectors. 
           [0016]      FIGS. 10A through 10C  show a disconnect protector with a pivoting latch that prevents a threaded lock from rotating and, in a variation, also prevents the separation of the mating parts of the connector. 
           [0017]      FIG. 10D  shows a clip-on-type embodiment of a disconnect protector. 
           [0018]      FIG. 11  shows a another clip-on type embodiment of a disconnect protector. 
           [0019]      FIG. 12  shows a clam-shell embodiment of a disconnect protector. 
           [0020]      FIG. 13  shows a portion of a medical tubing set support with an unused region that may be punched and formed to form one or more disconnect protectors. 
           [0021]      FIGS. 14A through 14C  show a disconnect protector that prevents rotation of a lock by a releasable ratchet mechanism. 
           [0022]      FIGS. 15A and 15B  show the ratchet mechanism of the embodiment of  FIGS. 14A and 14B . 
           [0023]      FIGS. 16A and 16B  show an adapter that can be added to a connector that lacks an appropriately-shaped portion with an edge to engage the disconnection protection device of the embodiments of  FIG. 2A , for example. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0024]    Referring to  FIG. 1 , a luer-type connector  100  has a male end  100 M and a female end  100 F. The male end  100 M has an internally-threaded barrel  106  that threads with bosses or threads (not shown, but see, for example, U.S. Pat. No. 4,452,473 to Ruschke; U.S. Pat. No. 4,639,019 to Mittleman; and U.S. Pat. No. 5,984,373 to Fitoussi, et al, which are hereby incorporated by reference as fully set forth herein) on the female end  100 F. The barrel  106  rotates relative to a male luer  104  (the conical mating portion of the connector is hidden within the barrel  106  and so is not shown, but is contiguous with the male luer  104 ) to engage the bosses or threads (again, not shown) to bring the female and male ends  100 F and  100 M together and force the male luer  104  into the female luer  110  (the conical recess that mates with the conical portion of the male luer  104  connector is hidden, partly within the barrel  106 , and so is not shown, but is contiguous with the female luer  110 ). Note that in an alternative embodiment, the threaded barrel  106  could be on the female luer  110  and thread with bosses on the male luer  104  to similar effect. Tubes  102  and  112  together with the luer-type connector  100  form a continuous channel when the male and female luers  104  and  110  are mated. Wings  108  may be provided on one or both of the male and female luers  104  and  110 . 
         [0025]    Referring now also to  FIGS. 2A ,  2 B and  3 , edges  114  and  116  provide engagement portions for a disconnection protection device  130  which can be fitted over the mated luer-type connector  100  as shown in  FIG. 3 . The disconnection protection device  130 , in the present embodiment, is of flexible material such as thermoplastic sheeting, steel, rubber, fiberglass or other composite, textile, or any suitable material that is resilient such that it can be bent as shown in  FIG. 2B  while springing back toward the relatively flat shape shown in  FIG. 2A . 
         [0026]    The disconnection protection device  130  can be moved over the luer-type connector  100  when bent as shown in  FIG. 4  and when released in the position shown in  FIG. 3 , engages an edge  133  of opening  132  with the edge  114  and engages an edge  135  of opening  131  with the edge  116 . Thus, in the position shown in  FIG. 4 , the disconnection protection device  130  prevents the male luer  104  and female luer  110  from moving apart. As a result, even if the barrel  106  is rotated to release the bosses or threads of the female end  100 F, the male and female ends  100 M and  100 F will not come apart. The disconnection protection device  130  need not hold the male and female ends  100 M and  100 F tightly since the luer-type of connector forms a slowly-expanding channel as the male luer withdraws from of the female luer. As a result, a small amount of separation will produce a similarly small leak area and the male and female ends  100 M and  100 F must be drawn apart a considerable distance for a large leak to occur. As shown in  FIG. 5 , the disconnection protection device  130  can be bent and passed over one of the tubes  112  and  102  and released so that it remains in close proximity to the luer-type connector  100  while freeing the luer-type connector  100  to be closed or opened. 
         [0027]    Referring to  FIG. 6 , a luer-type connector  200  has male a male end  200 M and a female end  200 F. The male end  200 M has an internally-threaded barrel  206  that threads with bosses or threads (again, not shown but as described above and in the documents incorporated by reference) on the female end  200 F. The barrel  206  rotates relative to a male luer  204  to engage the bosses or threads to bring the female and male ends  200 F and  200 M together and force the male luer  204  into the female luer  210 . Note that in an alternative embodiment, the threaded barrel  206  could be on the female luer  210  and thread with bosses on the male luer  204  to similar effect. Tubes  202  and  212  together with the luer-type connector  200  form a continuous channel when the male and female luers  204  and  210  are mated. As in the above embodiments, wings  208  may be provided on one or both of the male and female luers  204  and  210 . 
         [0028]    In the embodiment of  FIG. 6 , extensions  216  are provided on the barrel  206 . Also, there are four wings  208  on the female luer  210 . Referring now also to  FIGS. 7A and 8 , a disconnection protection device  230  has openings  240  and  241  which receive one of the extensions  216  and one of the wings  208 , respectively. As a result, when the disconnection protection device  230  is installed as discussed with reference to the embodiments of  FIGS. 1-5 , one extension  216 A and one wing  208 A fits through the openings  240  and  241 , respectively thereby inhibiting the barrel  206  from rotating relative to the female luer  210 . As a result, disconnection by unthreading the barrel internal threads from the female luer  210  bosses or threads is prevented. 
         [0029]    Referring to  FIG. 7B , instead of openings  240  and  241 , recesses  252  may be formed in a disconnection protection device  250  which is otherwise similar to that disconnection protection device  230  of  FIG. 7A . The recesses  7 B may be formed, for example, in thermoplastic sheeting, by molding, such as vacuum molding. Also, in alternative configurations, extensions  216  and wings  208  could be replaced by hook-shaped extensions that catch on or both of outer edges  237  of a device similar to the disconnection protection device  230 . Also, alternatively, the disconnection protection device could have an hourglass shape as shown in  FIG. 7C  that necks down to create a narrow center section  284  between the openings  285  such that the extensions  216 A wings  208 A will catch the edge of the narrow center section  284 . 
         [0030]    Referring to  FIGS. 9A ,  9 B, and  9 C, various alternative embodiments of disconnection protection device  271 ,  273 , and  275  are shown. Disconnection protection device  271  has rounded openings  373 , which is an alternative shape for the openings. The disconnection protection device  271  also has a bridging slot  375  which allows the disconnection protection device  271  to be snapped over the luer-type connector  100  or  200  rather than sliding it over the luer-type connector  100  or  200 . Disconnection protection device  273  has slots  279  which are formed to allow them to expand to admit the luer-type connector  100  or  200  and a bridging slot  371  which allows the disconnection protection device  273  to be snapped over the luer-type connector  100  or  200  disconnection protection device  275  has rectangular openings  277 . 
         [0031]    Referring to  FIG. 10A , a luer-type connector  300  has male a male end  300 M and a female end  300 F. The male end  300 M has an internally-threaded barrel  306  that threads with bosses or threads (again, not shown but as described above and in the documents incorporated by reference) on the female end  300 F. The barrel  306  rotates relative to a male luer  304  to engage the bosses or threads to bring the female and male ends  300 F and  300 M together and force the male luer  304  into the female luer  310 . Again, note that in an alternative embodiment, the threaded barrel  306  could be on the female luer  310  and thread with bosses on the male luer  304  to similar effect. Tubes  302  and  312  together with the luer-type connector  300  form a continuous channel when the male and female luers  304  and  310  are mated. 
         [0032]    Referring to  FIGS. 10A through 10C , attached to the female luer  310  is a pivoting latch  330  that locks the barrel  306  to prevent it from rotating. The latch  330  pivots on a hinge  337  which holds the latch on the female luer  310 . Protrusions  334  may be formed in the latch  330  to facilitated locking engagement of the barrel  305 , which may be provided with a knurled surface  336 .  FIG. 10A  shows the embodiment of the disconnection protection device  300  from a bottom perspective and  FIG. 10B  shows the same embodiment of the disconnection protection device  300  from the side.  FIG. 10C  shows the disconnection protection device  300  from the side with the latch  330  pivoted in a disengaged position to allow the barrel  306  to be rotated. The protrusions  334  may be shaped to cause the latch  330  to snap over the barrel  306 , thereby holding the latch  330  in position as shown in  FIGS. 10A and 10B . When engaged, the latch  330  prevents the barrel  306  from rotating relative to the female luer  310  thereby preventing the internal threads (not shown) of the barrel  306  from uncoupling from the bosses or threads (also not shown) of the female luer  310 . 
         [0033]      FIG. 10D  shows a snap-on variation of a disconnection protection device  350  which snaps to both a male luer  354  barrel  356  and a female luer  360  which has a knurled surface  367 . Protrusions  363  and  365  on a clip element  380  engage the knurled surface of the barrel  356  and the knurled surface  367  of the female luer  360 . This prevents the barrel  356  from rotating relative to the female luer  360  thereby preventing disconnection by preventing the internal threads (not shown) of the barrel  356  from uncoupling from the bosses or threads (also not shown) of the female luer  360 . The disconnection protection device  350  has narrow openings  362  and  369  that engage ends of the male luer  354  and the female luer  360  to prevent the male and female ends  350 M and  350 F from uncoupling even in the event the barrel  356  rotates or the threads are not engaged. 
         [0034]      FIG. 11  shows another clip-on variation of a disconnection protection device  400  which has slots  408  in extensions  402  and  404  which engage the ends (for example,  214  and  216 ) to prevent the luer-type connector  100 ,  200  from decoupling.  FIG. 12  shows a clamshell embodiment of a disconnection protection device  420  in which may be closed around the luer-type connector  100 ,  200  or similar connector. A curved leaf spring  422  closes the clamshell disconnection protection device  420  such that the covers  422  and  434  fully enclose the luer-type connector and such that the edges of the male and female luers (for example,  214  and  216 ) are held back while permitting the tubing to pass through openings  426  and  428 .  FIG. 13  shows a cartridge panel  450  which holds a tubing set which may include one or more luer-type connectors. The cartridge panel  450  may be made of sheet material whose properties are suitable for some of the disconnection protection devices described herein. The cartridge panel may have various cutouts and other shapes formed in it in various operations such as punching and vacuum-forming. An unused area is shown at  452  and the outline of a disconnection protection device  454  is shown. In the embodiment, the disconnection protection device  454  is formed and cut from the cartridge panel  450  during its manufacture. The cartridge panel is described in U.S. Pat. No. 6,579,253 to Burbank, et al, hereby incorporated by reference as if fully set forth herein. 
         [0035]    Referring to  FIGS. 14A and 14B , a luer-type connector  500  has male a male end  500 M and a female end  500 F. The male end  500 M has an internally-threaded barrel  506  that threads with bosses or threads (again, not shown but as described above and in the documents incorporated by reference) on the female end  500 F. The barrel  506  rotates relative to a male luer  504  to engage the bosses or threads to bring the female and male ends  500 F and  500 M together and force the male luer  504  into the female luer  510 . Again, note that in an alternative embodiment, the threaded barrel  506  could be on the female luer  510  and thread with bosses on the male luer  504  to similar effect. Tubes  502  and  512  together with the luer-type connector  300  form a continuous channel when the male and female luers  304  and  310  are mated.  FIG. 14B , which shows the luer-type connector  500  uncoupled, shows a tapered end  534  of the male luer  504  and an end  536  of the female luer  510  which has the mating conical recess that receives the male luer  504  tapered end  534 . 
         [0036]    The luer-type connector  500  has a disconnection protection device integrated in the design of the connector. On the female luer  510 , a ratchet barrel  508  has a ratchet  526  with teeth  528  which is urged toward a circular rack  538  by a living hinge  565 . The teeth of both the rack  538  and ratchet  526  are shaped to cause them to engage such that the barrel  506  cannot turn relative to the ratchet  526  of the female luer  510 , thereby preventing unthreading. This is similar to the well-known structure of cable ties, typically made of nylon. As shown in  FIG. 14C , the living hinge  565  allows pressure to be applied to the top of the ratchet  526  by squeezing or pinching the ratchet barrel  508 . This causes the ratchet surface  528  to withdraw from the circular rack  538  disengaging the barrel  506  allowing the luer-type connector  500  to be uncoupled. In this embodiment, as in the others, the ratchet could be provided on the male end and the rack on the female end of the luer-type connector with similar effect. This is true in all of the above embodiments, whether specifically indicated with respect to the embodiment or not. 
         [0037]    In an embodiment, the connector protection device prevents the disengagement of two mating connectors which have a locking component that maintains the connection between the mating connectors by non-frictional means. For example, the two connectors may be screwed together or clamped together. Clamps and screws provide a positive engagement between the mating connectors. Whereas a luer connector without a locking thread portion, such as the prior art luer connectors lacking a locking device, relied on frictional engagement between the male and female luer to maintain the connection between the male and female connector components. In the embodiment, a protector helps to ensure that the connectors do not come apart either by backing the connector element up or by preventing it from disengaging and thereby permitting the connectors from coming apart. So, for example, if the connectors are luer connectors and the locking component is a threaded barrel, the connector protection device could serve the function defined by either preventing the barrel from rotating or by preventing the male and female luers from separating if the threaded barrel fails. Thus, in the embodiment, the connection protection device is one or both of: (1) a device that prevents the decoupling of the connectors such that failure of the connection is either prevented or inhibited by holding the connectors together and (2) a device that locks the locking component, thereby preventing it from failing to do its job. 
         [0038]    In the embodiment of  FIGS. 1 through 5 , the locking element is the barrel  106  and the connector protection element is the disconnection protection device  130 . The disconnection protection device  130  falls into the first category; that is, it prevents the decoupling of the connectors (male luer  104  and female luer  110 ) such that failure of the connection is either prevented or inhibited by holding the connectors together embodiment. 
         [0039]    In the embodiments of  FIGS. 9A through 9C , the disconnection protection devices  271 ,  273 , and  275  perform the same role. In the embodiments of  FIGS. 6 through 8 , the disconnection protection devices  230  and  250  also perform the same role of preventing the decoupling of the connectors (male luer  204  and female luer  210 ) such that failure of the connection is either prevented or inhibited by holding the connectors together but they also serve the second role of locking the locking component (i.e., the barrel  206 ), thereby preventing the barrel  216  from failing to do its job. 
         [0040]    In the example of the embodiment of  FIGS. 6 through 8 , the barrel  206  is prevented from rotating relative to the female luer  210  by causing the extension  216  and the wing of the female luer  210  from engaging a common element, namely the disconnection protection device  230 . This in turn prevents relative rotation of the female luer  210  and the barrel  206  thereby preventing disengagement of the barrel threads from the female luer bosses or threads. 
         [0041]    In the embodiment of  FIGS. 10A through 10C , the locking element is the barrel  306  and the connector protection element is the latch  330 . The disconnection protection device  330  falls into the second category; that is, it locks the locking component (the barrel  306 ), thereby preventing it from failing to do its job of holding the threaded elements in continuous engagement to keep the male and female luers  304  and  310  mated. The embodiment of  FIG. 10D  is similar to the embodiment of  FIGS. 10A  in that the locking element, the barrel  356  is prevented from rotating. But in this case, the disconnection protection device  352  also prevents the separation of the male and female luers  354  and  360 . Thus, the disconnection protection device  350  falls into both categories  1  and  2 . 
         [0042]    In the disconnection protection device  500  of  FIGS. 14A through 15B , the locking element is the barrel  506  and the connection protection element is the ratchet  526 . The disconnection protection device  500  thus fits in category  2  because it prevents the barrel  506  from disengaging with the female luer  510 . 
         [0043]    In an embodiment of the invention, the connectors are luer connectors. In another, or a refinement of any of the foregoing embodiments, the connectors are used to secure a line of a medical treatment device. In yet another, or a refinement of any of the foregoing embodiments, the connectors connect blood-conveying lines of a medical treatment device. In another, or a refinement of any of the foregoing embodiments, the locking element includes a ratchet. In a further refinement, it includes rack that is engageable with the ratchet. In yet another, or a refinement of any of the foregoing embodiments, the connectors are male and female luers and the locking element includes a threaded barrel on either the male or female luer that engages on a mating portion of the other of the male and female luer. 
         [0044]      FIGS. 16A and 16B  show an adapter that can be added to connector components that do not have an edge that can securely engage the disconnection protection device of  FIG. 2A , for example. A connector  614 , in this case a female luer which is secured to a catheter  640  has tabs  616  that engage threads of standard locking male luer connectors. A connector adapter  642  has a male luer with a recess  658  that has threads  618  to engage the tabs  616  in precisely the manner of a standard locking male luer connector. Integrally formed in the connector adapter  642  is a connector  630 , that replicates the original connector  614 , in this case, a female luer. When threaded onto the original connector  614 , the connector adapter defines a continuous channel from the connector  630  to the original connector  614 . The connector adapter  642  is additionally fastened to the connector  614  by a flexible band that is received in recesses  650  such that it wraps tightly to the diameter of the catheter  640 . Thus, the connector  614  is held in the recess  658  such that even if the it disengages from the threads  618 , it cannot withdraw from the connector adapter  642 . 
         [0045]    The connector adapter  642  provides a flange  640  that can engage the disconnect protection device  624 . In the example shown in  FIG. 16B , a male luer  604  with a threaded barrel  606  is connected to the female luer  630  of the connector adapter  642 . The disconnection protection device  630  is engages the flange  640  and the male luer  604  edge  614  thereby preventing the disconnection of the catheter  640  from a fluid line  622 . 
         [0046]    In any of the above embodiments, the type of connector could be luer-type connector or any other connector which rely on mutually rotatable parts on the connecting elements or which slide apart to disconnect or both. 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 connectors forming parts of junctions, other components such as valves or filters, and others. 
         [0047]    While the present invention has been disclosed with reference to certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.