Patent Document

CROSS REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims the benefit of U.S. Provisional Patent Application 60/554,882 filed on Mar. 19, 2004 and U.S. Provisional Patent Application 60/551,871 filed on Oct. 16, 2003. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to catheters for the extracorporeal treatment of patients. Specifically, this invention relates to devices that are used to releasably secure a catheter to an extracorporeal treatment device, such as a hemodialysis machine.  
       BACKGROUND OF THE INVENTION  
       [0003]     Catheters may be located in various venous locations and cavities throughout the body of a patient for introduction of fluids to a body or removal of fluids from the body. Such catheterization may be performed by using a single catheter having multiple lumens. A typical example of a multiple lumen catheter is a dual lumen catheter assembly in which one lumen introduces fluid and the other lumen removes fluid. An example of such a dual lumen catheter assembly is the SPLIT-CATH® catheter. Alternatively, catheterization may be performed by using multiple single-lumen catheters, such as TESIO® catheters.  
         [0004]     Generally, to insert any catheter into a blood vessel, the vessel is identified by aspiration with a long hollow needle in accordance with the well known Seldinger technique. When blood enters a syringe attached to the needle, indicating that the vessel has been found, a thin guidewire is then introduced, typically through a syringe needle or other introducer device into the interior of the vessel. The introducer device is then removed, leaving the guidewire within the vessel. The guidewire projects beyond the surface of the skin. At this point, several options are available to a physician for catheter placement. The simplest is to pass a catheter into the vessel directly over the guidewire. The guidewire is then removed, leaving the catheter in position within the vessel. However, this technique is only possible in cases where the catheter (for example, a small diameter dual lumen catheter) is of a relatively small diameter, made of a stiff material, and not significantly larger than the guidewire. If the catheter to be inserted is significantly larger than the guidewire, a dilator device containing a sheath is passed over the guidewire to enlarge the opening in the vessel. The dilator is then removed along with the guidewire, leaving the sheath in place, and the catheter is then passed through the sheath into the vessel. The guidewire is then removed, leaving the catheter in position within the vessel.  
         [0005]     Each catheter lumen is typically connected to a distal end of an extension tube via a hub. Each extension tube has a standard connector at its proximal end for connection to a medical device, such as a hemodialysis machine. Such connectors are commonly referred to as “luers”. A luer is a standard fitting that accommodates the fluid connection of the lumen to an extracorporeal treatment device, such as the hemodialysis machine, as well as a cap or an inducer for medicaments. Generally, in the hemodialysis process, the catheter luer is connected to a mating luer that is in fluid communication with to the hemodialysis machine. While the process of connecting the luers together generally forms a secure connection, there is a possibility that the connection would become disengaged, leading to blood loss, contamination or the introduction of air embolisms into the blood stream. It would be beneficial to provide a device that releasably attaches to the connection and provides additional security for the luer connection and resistance to detachment of the extracorporeal treatment device.  
       BRIEF SUMMARY OF THE INVENTION  
       [0006]     Briefly, the invention provides a clip for retaining a first conduit to a second conduit, the first conduit including a first connector and the second conduit including a second connector. The first connector is releasably connected to the second connector. The clip comprises a base portion and a first clip portion extending away from the base portion. The first clip portion has a first opening that is sized to frictionally retain the first connector. The clip further comprises a second clip portion disposed, on the base portion away from the first clip portion. The second clip portion includes a second opening that is sized to frictionally retain the second connector.  
         [0007]     The invention further provides a clip for retaining a first conduit to a second conduit, the first conduit including a first connector and the second conduit including a second connector. The clip comprises a proximal portion and a distal portion. The proximal portion comprises a first proximal leg and a second proximal leg. The second proximal leg is attachable to the first conduit. The distal portion comprises a first distal leg and a second distal leg. The second distal leg is attachable to the second conduit.  
         [0008]     Further, the invention provides a method for securing a first conduit to a second conduit. The method comprises providing a first conduit having a first connector, a second conduit having a second connector and a clip. The clip comprises a base and a first end and a second end extending perpendicularly from the base. The method comprises attaching the first connector to the second connector. The method further comprises attaching the first end of the clip to one of the first connector and the second connector and attaching the second end of the clip to the other of the first connector and the second connector. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]     The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred 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. In the drawings:  
         [0010]      FIG. 1  is a side elevation view of a luer clip according to a first embodiment of the present invention.  
         [0011]      FIG. 2  is a sectional view of the luer clip taken along line  2 - 2  of  FIG. 1 .  
         [0012]      FIG. 3  is a sectional view of the luer clip taken along line  3 - 3  of  FIG. 1 .  
         [0013]      FIG. 4  is a top plan view of the luer clip of  FIG. 1 .  
         [0014]      FIG. 5  is a side elevation view of the luer clip of  FIGS. 1-4  being connected to an extension tube of a catheter.  
         [0015]      FIG. 6  is a side elevation view of the luer clip of  FIGS. 1-4  being proximally translated along the extension tube of the catheter.  
         [0016]      FIG. 6   a  is a sectional view of a portion of the luer clip shown in  FIG. 6 .  
         [0017]      FIG. 7  is an enlarged side elevation view of the luer clip of  FIGS. 1-4  connecting a female luer connector on a catheter to a male luer connector on a hemodialysis machine.  
         [0018]      FIG. 8  is an exploded perspective view of a luer clip according to a second embodiment of the present invention.  
         [0019]      FIG. 8   a  is an alternate exploded perspective view of the luer clip of  FIG. 8 .  
         [0020]      FIG. 9  is an exploded sectional view of the luer clip shown in  FIG. 8 .  
         [0021]      FIG. 10  is a side elevational view of the luer clip shown in  FIGS. 8 and 9  being connected to a luer connection.  
         [0022]      FIG. 11  is a perspective view of a luer clip according to a third embodiment of the present invention.  
         [0023]      FIG. 12  is a front elevational view of the luer clip of  FIG. 11 .  
         [0024]      FIG. 13  is a top plan view of the luer clip of  FIG. 12 .  
         [0025]      FIG. 14  is a side elevational view of the luer clip of  FIG. 11 , with a luer connection inserted therein. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0026]     In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The words “proximal” and “distal” refer to the right side and the left side of the luer clip according to the present invention as shown in  FIG. 1 . Generally, in use, “proximal” refers to a direction that is closer to the extracorporeal treatment device or inserting physician and “distal” refers to a direction that is closer the patient or the inserted tip of the catheter. The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The following describes preferred embodiments of the invention. However, it should be understood based on this disclosure, that the invention is not limited by the embodiments described herein.  
         [0027]     Referring now to the drawings in detail, there is shown in  FIGS. 1-4  a luer clip  100  according to a first embodiment of the present invention. Preferably, the luer clip  100  is constructed from polypropylene, although those skilled in the art will recognize that the luer clip  100  may be constructed from other, suitable materials.  
         [0028]     The luer clip  100  includes a base  110  having a distal end  112  and a proximal end  114 . The base  110  is generally parallelpiped in shape, with orthogonal sides. The base  110  is bisected by a plane  116  that extends perpendicularly from the plane of the paper in  FIG. 4 . The luer clip  100  is preferably a mirror image on either side of the plane  116 .  
         [0029]     Referring to  FIGS. 1 and 2 , a distal clip portion  120  extends perpendicularly from the distal end  112 . The distal clip portion  120  includes a first distal clip leg  121  having a generally flat interior side  122  and a generally concave exterior side  124 . A tang  126  extends from a free end of the leg  121  toward the plane  116 . The tang  126  includes a generally flat bottom face  127  and a beveled top face  128 . The distal clip portion  120  also includes a second distal clip leg  131  having a generally flat interior side  132  and a generally concave exterior side  134 . A tang  136  extends from a free end of the leg  131  toward the plane  116 . The tang  136  includes a generally flat bottom face  137  and a beveled top face  138 . The first distal clip leg  121  and the second distal clip leg  131  are preferably mirror images of each other across the plane  116 . The first distal clip leg  121  and the second distal clip leg  131  are separated by a generally rectangular opening  140  generally defined by the interior sides  122 ,  132 , the bottom faces  127 ,  137 , and the base  110 . While a rectangular opening is shown in  FIG. 2 , those skilled in the art will recognize that the opening may be varied in shape.  
         [0030]     Referring now to  FIGS. 1 and 3 , a proximal clip portion  150  extends generally perpendicularly from the proximal end  114  of the base  110  and parallel to the distal clip portion  120 . The proximal clip portion  150  includes a first proximal clip leg  151  having a generally flat exterior side  152  and an interior side  154 . A lower portion  155  of the interior side  154  is arcuate, while an upper portion  156  of the interior side  154  is indented. An extension  158  extends at an angle β from the leg  151  away from the base  110  and the distal clip portion  120 . Preferably, the angle β is approximately 30 degrees, although those skilled in the art will recognize that the angle β may be more or less than 30 degrees.  
         [0031]     The proximal clip portion  150  also includes a second proximal clip leg  161  having a generally flat exterior side  162  and an interior side  164 . A lower portion  165  of the interior side  164  is arcuate, while an upper portion  166  of the interior side  164  is indented. The lower portion  165  of the interior side  164  mates with the lower portion  155  of the interior side  154  to form an arc extending approximately 240 degrees. An extension  168  extends at an angle β from the leg  161  away from the base  110 . Preferably, the angle β is approximately 30 degrees, although those skilled in the art will recognize that the angle β may be more or less than 30 degrees. The first proximal clip leg  151  and the second proximal clip leg  161  are separated by a generally U-shaped opening  170  generally defined by the interior sides  154 ,  164 , with the lower portions  155 ,  165  of the interior sides  154 ,  164 , respectively, forming the bottom portion of the “U”.  
         [0032]     A catheter assembly  200 , to which the luer clip  100  is attached, is connected to a hemodialysis machine according to standard procedures. The hemodialysis machine includes an extracorporeal bloodline  230  with a male luer  240  disposed on the distal end of the bloodline  230 , shown in  FIG. 5 , that is releasably connected to the female luer  220  of the catheter assembly  200  according to known methods. The bloodline  230  includes a narrowed neck portion  232  disposed immediately proximate of the male luer  240 .  
         [0033]     Preferably, as shown in  FIGS. 6 and 6   a , a retaining ridge  242  is disposed circumferentially around the male luer  240 . A threaded swivel  241  is adapted to be snapped on to the male luer  240  and retained about the retaining ridge  242 . As assembled, the threaded swivel  241  is free to rotate about the male luer, thereby facilitating a threaded engagement between the male luer  240  and the female luer  220  without having to rotate the male luer  240  or the female luer  220 .  
         [0034]     Referring now to  FIG. 5 , the clip  100  is connected to the catheter assembly  200  having an extension tube  210  with a female luer  220 , having a distal end  222 , disposed on the proximal end of the extension tube  210 . At least one ridge  221  is disposed on the distal end  222  of the female luer  220 . Preferably, two ridges  221  are located on opposing sides of the female luer  220 . The ridges  221  are disposed proximate to the interior sides  122 ,  132  of the distal clip portion  120  when the luer clip  100  is disposed about the female luer  220 . While generally rectangular ridges  221  are shown in  FIGS. 5, 6  and  7 , it will be known to those skilled in the art that the ridges  221  may take any shape that will accommodate the profile of the rectangular opening  140  of the distal clip portion  120  as shown in  FIG. 2 . The clip  100  is connected to the catheter assembly  200  by disposing the catheter extension tube  210  into the generally rectangular opening  140  formed by the distal clip legs  121 ,  131  and the base  110 . During insertion, the extension tube  210  is forced against each of the beveled top faces  128 ,  138  of the tangs  126 ,  136 , respectively. The tangs  126 ,  136  each bias away from the plane  116  sufficiently to allow the extension tube  210  to be disposed within the generally rectangular opening  140 , as shown by the arrow “A”. After the extension tube  210  is disposed within the generally rectangular opening  140 , the resiliency of the material forming the luer clip  100  allows the tangs  126 ,  136  to return to their unbiased position, securely retaining the extension tube  210  within the generally rectangular opening  140 .  
         [0035]     The luer clip  100  is translated proximally along the extension tube  210 , as shown by the arrow “B” in  FIG. 6 , until the distal end  222  of the female luer  220  on the proximal end of the extension tube  210  is disposed within the generally rectangular opening  140 . The narrowed neck  232  of the bloodline  230  is then disposed within the generally U-shaped opening  170  until the bloodline  230  engages the lower portions  155 ,  165  of the interior sides  154 ,  164  of the proximal clip legs  151 ,  161 .  
         [0036]     The narrowed neck portion  232  of the bloodline  230  is sufficiently long to frictionally retain the proximal clip portion  150  on the narrowed neck portion  232  between the bloodline  230  and the male luer  240 . The proximal clip portion  150  is spaced from the distal clip portion  120  sufficiently to retain the female luer  220  and the male luer  240  therebetween. The clip  100  is now securely connected to the catheter assembly  200  and the bloodline  230 , as shown in  FIG. 7 , so that the catheter assembly  200  and the bloodline  230  are securely connected to each other. Hemodialysis may now begin.  
         [0037]     To remove the clip  100  from the bloodline  230  so that the bloodline  230  can be removed from the catheter assembly  200 , the extensions  158 ,  168  are biased to the left and downward from the position shown in  FIG. 7 . The narrowed neck portion  232  of the bloodline  230  snaps out of the proximal clip portion  150  so that the clip  100  may be slid distally along the catheter extension tube  210 . The hemodialysis machine and the catheter assembly  100  are secured according to standard procedures. The female luer  220  may be disconnected from the male luer  240  and the bloodline  230  is disconnected from the catheter assembly  200 .  
         [0038]     While only one extension tube  210  on the catheter assembly  200  is discussed, those skilled in the art will recognize that, for a multi-lumen catheter assembly, such as the catheter assembly  200  shown in  FIGS. 5 and 6 , a luer clip  100  may also be disposed on the remaining extension tube in the same manner as described above with respect to the extension tube  210 .  
         [0039]     Referring now to  FIGS. 8-10 , a second embodiment of a luer clip  300  is shown. The luer clip  300  includes a proximal portion  310  and a distal portion  330 . The proximal portion  310  is preferably generally “L-shaped”, with a first leg  312  extending toward the distal portion  330  and a second leg  314  extending preferably perpendicular to the first leg  312 . Preferably, the second leg  314  extends from a proximal end  311  of the proximal portion  310 . The first leg  312  includes an insertion slot  316  that extends from a distal end  318  of the first leg  312  toward the second leg  314 . Further, a plurality of locking slots  320  extend from the insertion slot  316  to the exterior of the first leg  312 .  
         [0040]     The second leg  314  includes a pair of preferably mirror image leg portions  322 ,  324 . The leg portions  322 ,  324  are separated by a generally U-shaped opening  326 . Free ends  322   a ,  324   a  of each of the leg portions  322 ,  324 , respectively, extend into the generally U-shaped opening  326 . Each free end  322   a ,  324   a  also includes a nub  322   b ,  324   b  that extends away from each leg portion  322 ,  324  generally toward the distal portion  330 .  
         [0041]     The distal portion  330  is preferably generally “L-shaped”, with a first leg  332  extending toward the proximal portion  310  and a second leg  333  extending preferably perpendicular to the first leg  332 , distal from the proximal portion  310 . The first leg  332  is sized to be disposed within the insertion slot  316 . The first leg  332  includes a beveled tab  334  that is sized to be disposed within any of the locking slots  320  when the first leg  332  is disposed within the insertion slot  316 . During insertion, the first leg  332  of the distal portion  330  is slid towards the first leg  312  of the proximal portion  310 , in the direction of the arrow “A” shown in  FIG. 9 .  
         [0042]     The second leg  333  includes a pair of preferably mirror image leg portions  342 ,  344 . The leg portions  342 ,  344  are separated by a generally U-shaped opening  346 . Free ends  342   a ,  344   a  of each of the leg portions  342 ,  344 , respectively, extend into the generally U-shaped opening  346 . Each free end  342   a ,  344   a  also includes a nub  342   b ,  344   b  that extends away from each leg portion  342 ,  344  generally toward the proximal portion  310 .  
         [0043]     Referring now to  FIG. 10 , the catheter assembly  200  is connected to the extracorporeal bloodline  230 , with the female luer  220  of the catheter assembly  200  releasably connected to the male luer  240  of the extracorporeal bloodline  230 .  
         [0044]     Preferably, the extracorporeal bloodline  230  is inserted between the leg portions  322 ,  324  of the proximal portion  310  and into the generally U-shaped opening  326  such that the first leg  312  is disposed toward the distal portion  330 . Similarly, the extension tube  210  is inserted between the leg portions  342 ,  344  of the distal portion  330  and into the generally U-shaped opening  346  such that the first leg  332  is disposed toward the proximal portion  310 . The first leg  332  of the distal portion  330  is then inserted into the insertion slot  316  and the proximal portion  310  and the distal portion  330  are drawn toward each other, with the distal portion  330  being slid in the direction of arrow “A” shown in  FIG. 9 , while securing the female luer  220  of the catheter assembly  200  and the male luer  240  of the extracorporeal bloodline  230  between the second leg  314  of the proximal portion  310  and the second leg  333  of the distal portion  330 . The tab  334  engages one of the locking slots  320 , securely retaining the distal portion  330  and the proximal portion  310  together. The clip  300  now securely connects the catheter assembly  200  and the extracorporeal bloodline  230 .  
         [0045]     The clip  300  may be removed in one of several ways. The clip  300  may be snapped apart, so that the clip  300  may not be reused. In such an instance, it is preferred that the clip  300  is constructed from a relatively brittle material, such as ABS or other suitable material. Alternatively, the clip  300  may be removed by forcing the tab  334  away from the locking slots  320  and pulling the proximal portion  310  and the distal portion  330  away from each other. In such an instance, it is preferred that the clip  300  is constructed from polyethylene, polypropylene, or some other suitable material.  
         [0046]     Another alternate embodiment of a luer clip  400  according to the present invention is shown in  FIGS. 11-14 . The luer clip  400  includes a proximal portion  410  and a distal portion  430 . The proximal portion  410  is preferably generally “L-shaped”, with a first leg  412  extending toward the distal portion  430  and a second leg  414  extending preferably perpendicular to the first leg  412 , distal from the distal portion  430 . The first leg  412  includes an insertion slot  416  that extends from a distal end  418  of the first leg  412  toward the second leg  414 . Further, a plurality of ratchet teeth  420  are disposed along the interior of the insertion slot  416 . A first and second retaining leg  418 ,  419  are disposed on the first leg  410 . Preferably the first and second retaining legs  418 ,  419  are disposed on the side of the first leg  410  that is closer to the catheter assembly  200  when the luer clip  400  is disposed about the catheter assembly  200 . The first retaining leg  418  is spaced apart from the second retaining leg  419 .  
         [0047]     The second leg  414  includes a pair of preferably mirror image leg portions  422 ,  424 . The leg portions  422 ,  424  are separated by a generally U-shaped opening  426 . Free ends  422   a ,  424   a  of each of the leg portions  422 ,  424 , respectively, extend into the generally U-shaped opening  426 .  
         [0048]     The distal portion  430  is preferably generally “L-shaped”, with a first leg  432  extending toward the proximal portion  410  and a second leg  433  extending preferably perpendicular to the first leg  432 , distal from the proximal portion  410 . The first leg  432  is sized to be disposed within the insertion slot  416 . The first leg  432  includes a locking pawl  434  that is sized to engage the ratchet teeth  420  when the first leg  432  is disposed within the insertion slot  416 . The first leg  432  also includes a reinforcing rib  436  juxtaposed away from the locking pawl  434  to provide support for the first leg  432 . The reinforcing rib  436  is sized to fit between the first retaining leg  418  and the second retaining leg  419 .  
         [0049]     The second leg  433  includes a pair of preferably mirror image leg portions  442 ,  444 . The leg portions  442 ,  444  are separated by a generally U-shaped opening  446 . Free ends  442   a ,  444   a  of each of the leg portions  442 ,  444 , respectively, extend into the generally U-shaped opening  446 .  
         [0050]     Referring now to  FIG. 14 , the catheter assembly  200  is connected to the extracorporeal bloodline  230 , with the female luer  220  of the catheter assembly  200  releasably connected to the male luer  240  of the extracorporeal bloodline  230 .  
         [0051]     Preferably, the extracorporeal bloodline  230  is inserted between the leg portions  422 ,  424  of the proximal portion  410  and into the generally U-shaped opening  426  such that the first leg  412  is disposed toward the distal portion  430 . Similarly, the extension tube  210  is inserted between the leg portions  442 ,  444  of the distal portion  430  and into the generally U-shaped opening  446  such that the first leg  432  is disposed toward the proximal portion  410 . The first leg  432  of the distal portion  430  is then inserted into the insertion slot  416  and the proximal portion  410  and the distal portion  430  are drawn toward each other, while securing the female luer  220  of the catheter assembly  200  and the male luer  240  of the extracorporeal bloodline  230  between the second leg  414  of the proximal portion  410  and the second leg  433  of the distal portion  430 . The locking pawl  434  engages the ratchet teeth  420  so that the first leg  432  of the distal portion  430  can only be advanced in the proximal direction, securely retaining the distal portion  430  and the proximal portion  410  together. The clip  400  now securely connects the catheter assembly  200  and the extracorporeal bloodline  230 .  
         [0052]     To remove the clip  400 , it is preferred that the clip  400  is snapped apart, so that the clip  400  may not be reused. In such an instance, it is preferred that the clip  400  is constructed from a relatively brittle material, such as ABS or other suitable material. Alternatively, the clip  400  may be removed by forcing the locking pawl  434  away from the ratchet teeth  420  and pulling the proximal portion  410  and the distal portion  430  away from each other. In such an instance, it is preferred that the clip  400  is constructed from polyethylene, polypropylene, or some other suitable material.  
         [0053]     It will be appreciated by those skilled in the art that changes could be made to the embodiment described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiment disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

Technology Category: 4