Abstract:
The present invention relates to a dialyzer holder to attach a dialyzer to a dialysis machine. During priming of a bloodline prior to a dialysis treatment, the dialyzer holder grips a dialyzer in approximately the center of the dialyzer, but allows movements of the dialyzer in an arc motion using two axes of rotation. The holder enables the dialyzer to move to a position where air can be primed from the dialyzer and, because the dialyzer can move toward the dialysis machine, this motion eliminates stress on the tubing connected to the bottom and top of the dialyzer and reduces the length of bloodline tubing necessary to accommodate dialyzer movement. The dialyzer holder incorporates an attachment point for a venous chamber for use during the priming procedure, enabling the venous chamber to move with the dialyzer, further reducing the tubing between the dialyzer and the venous chamber.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/798,273, filed Mar. 15, 2013, the entirety of which is incorporated by reference herein. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    During set-up of a typical dialysis treatment, the blood side and dialysate side of the dialyzer are primed with saline. The dialyzer is typically rotated about its axis to invert the dialyzer. This is done to expel any air contained within the dialyzer blood compartment and dialysate compartment. This movement requires excess length of tubing that attaches the bloodline tubing to the dialyzer blood ports. Because this excess tubing length is only required during the priming procedure, it is excess tubing length and associated blood volume that is not required as part of the dialysis treatment. 
       SUMMARY OF THE INVENTION 
       [0003]    The present invention provides for a dialyzer holder, which grips the dialyzer in approximately the center of the dialyzer, but allows movements of the dialyzer in an arc motion using two axes of rotation. This holder enables the dialyzer to move to a position where air can be primed from the dialyzer and, because the dialyzer moves toward the dialysis machine, this motion eliminates stress on the tubing connected to the bottom and top of the dialyzer, eliminating the need for longer bloodline tubing lengths to accommodate dialyzer movement. The dialyzer holder incorporates an attachment point for a venous chamber for use during the priming procedure, enabling the chamber to move with the dialyzer, further reducing the need to have excessive tubing between the dialyzer and the venous chamber. 
         [0004]    Accordingly, example embodiments of the present invention relate to a holder for a dialyzer, having a blood side and a dialysate side both connected with tubing to a dialysis machine, configured to allow priming of the blood side and the dialysate side of the dialyzer without disconnecting the blood side or the dialysate side tubing from the dialysis machine. The holder has a dialyzer attachment member for securing the dialyzer in position and a rotational assembly connected to the attachment member, enabling it to rotate from an upright (e.g., vertical or substantially vertical) position used for priming the blood side of the dialyzer to a position more than 90 degrees from vertical for priming the dialysate side of the dialyzer. This holder enables the dialysate side of the dialyzer to be primed without disconnecting the blood side and it decreases the length of tubing necessary to retain the connection of the blood side of the dialyzer to the dialysis machine. Alternative embodiments can include enabling the dialyzer to rotate up to about 100 degrees from vertical. In other embodiments, the dialyzer holder includes an attachment member for securing the dialyzer holder to a support member. 
         [0005]    In one embodiment, the dialyzer holder includes a venous chamber holder configured to attach a venous chamber about parallel to the dialyzer with the venous chamber fluidly connected to the blood side of the dialyzer. In some embodiments, the venous chamber includes an administration line having a hydrophobic vent adapted to remove gas from the blood side of the dialyzer. 
         [0006]    In another embodiment, the length of the tubing that connects the blood side of the dialyzer to the dialysis machine is a minimized to allow the dialyzer to be rotated without disconnecting the blood side or dialysate side tubing from the dialysis machine. 
         [0007]    In still another embodiment, the dialyzer holder&#39;s rotational assembly is configured to rotate the dialyzer about a rotational axis perpendicular to the long axis of the dialyzer. Alternative embodiments can include the rotational assembly configured to rotate the dialyzer counterclockwise. In a further embodiment, the dialyzer holder includes a second rotational assembly. The second rotational assembly can be configured to rotate the dialyzer about a second rotational axis perpendicular to the long axis of the dialyzer. Alternative embodiments can include the second rotational assembly configured to rotate the dialyzer counterclockwise. 
         [0008]    In yet another example embodiment, a holder for a dialyzer, the dialyzer having a blood side and a dialysate side both connected with tubing to a dialysis machine, is configured to allow priming of the blood side and dialysate side of the dialyzer without disconnecting the blood side or dialysate side tubing from the dialysis machine. The holder has a dialyzer attachment member for securing the dialyzer in position, a first rotational member connected to the attachment member with a first rotational axis to allow the dialyzer to rotate from an upright (e.g., vertical or substantially vertical) position to a position about 45 degrees from substantially vertical, and a second rotational member connected to the attachment member with a second rotational axis allowing the dialyzer to rotate an additional about 55 degrees from the substantially vertical position to a position for priming the dialysate side of the dialyzer. Thus, this dual-axis configuration allows the dialysate side of the dialyzer to be primed without disconnecting the blood side while decreasing the length of tubing necessary to retain the connection of the blood side of the dialyzer to the dialysis machine. 
         [0009]    Another example embodiment of the present invention relates to a method of priming a dialysis machine. The method includes connecting a blood line to a blood side, a dialysate line to a dialysate side, a pump loop, and a volume of saline to a dialyzer, priming the blood line with saline, rotating the dialyzer from an upright (e.g., vertical or substantially vertical) position for priming of the blood side of the dialyzer to a position more than 90° from the upright position for priming of the dialysate side of the dialyzer, thereby allowing priming of the dialysate side of the dialyzer without disconnecting the blood side while decreasing the length of tubing necessary to retain the connection of the blood side of the dialyzer to the dialysis machine, priming the dialysate side of the dialyzer with saline, and returning the dialyzer to an upright position, the dialyzer being held in a dialyzer holder including a dialyzer attachment member and a first rotational assembly connected to the attachment member. 
         [0010]    In some embodiments of the method of priming a dialysis machine, the method further includes connecting a venous chamber to the blood line and attaching the venous chamber to the dialyzer by a venous chamber holder connected to the dialyzer attachment member prior to priming the blood line with saline. Rotating the dialyzer may include rotating up to about 100° from vertical. 
         [0011]    In another embodiment, rotating the dialyzer includes rotating the dialyzer counterclockwise about the rotational axis. Rotating the dialyzer may include rotating about a second rotational assembly connected to the attachment member at a second connection, the second rotational assembly being configured to rotate the dialyzer about a second rotational axis perpendicular to the length of the dialyzer. In another embodiment, rotating the dialyzer about the second rotational assembly includes rotating the dialyzer counterclockwise about the second rotational axis. 
         [0012]    In some embodiments, the method further includes removing gas from the blood line through an administration line having a hydrophobic vent on the administration line. 
         [0013]    Compared to prior art dialyzers and corresponding methods of priming, the features of the present invention reduce the need for excess tubing. This reduces the risk of tangling the tubing when priming the dialysate side and generally when operating the dialysis machine. This feature also eliminates the need to disconnect the blood side of the dialyzer while priming the dialysate side. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    The foregoing will be apparent from the following more particular description of example embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments of the present invention. 
           [0015]      FIG. 1  is a diagram of a single axis dialyzer holder having elements of the present invention with an attached dialyzer connected to a dialysis machine. 
           [0016]      FIG. 2  is a diagram of the dialyzer holder of  FIG. 1  positioned to prime the dialysate side of the attached dialyzer. 
           [0017]      FIG. 3  is a diagram of a dual-axis dialyzer holder. 
           [0018]      FIG. 4  is an exploded view of the dual-axis dialyzer holder of  FIG. 3 . 
           [0019]      FIG. 5  is a further exploded view of the dual-axis dialyzer holder of  FIG. 3 , showing internal elements. 
           [0020]      FIGS. 6A-C  are diagrams of the operation of the dual-axis dialyzer holder of  FIG. 3  with an attached dialyzer. 
           [0021]      FIGS. 7A-C  are photographs of the operation of the dual-axis dialyzer holder of  FIG. 3  with an attached dialyzer connected to a dialysis machine. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    A description of example embodiments of the invention follows. 
         [0023]    A dialyzer holder which grips the dialyzer in approximately the center of the dialyzer, but enables movement of the dialyzer in an arc motion is described herein. This holder enables the dialyzer to move to a position more than 90 degrees from vertical, where air can be evacuated from the dialyzer. Because the dialyzer moves toward the dialysis machine, this motion eliminates stress on the tubing connected to the bottom and top of the dialyzer, eliminating the need for longer bloodline tubing lengths to accommodate dialyzer movement. Additionally, shorter tubing lengths reduce the amount of blood outside of a patient&#39;s body during a dialysis treatment. The dialyzer holder includes a feature which temporarily holds the venous chamber during the priming procedure. Locating the venous chamber on the dialyzer holder enables the venous chamber to move with the dialyzer during priming. 
         [0024]    In another aspect, a hydrophobic vent on the drug administration line of the venous chamber enables the drug administration line to automatically fill with saline during the priming procedure. The line is provided with a clamp that can be opened during the priming procedure or at the end of the priming procedure to automatically vent air from the venous chamber and the administration line. When the clamp is opened, the air is pushed up the administration line by saline within the chamber. When the air has completely exited the administration line, the saline contacts the hydrophobic cap blocking additional saline flow. 
         [0025]      FIG. 1  shows a single axis dialyzer holder  10  having elements of the present invention. A dialyzer  119  having a blood side and a dialysate side is connected to a dialysis machine  199  by blood tubing. Dialyzer  119  is shown in an upright (e.g., vertical or substantially vertical) position. Dialysis machine  199  includes a peristaltic pump  198  to draw blood from a patient via arterial access tubing  111   c , pump it into the blood inlet side  110   a  of dialyzer  119  via blood supply tubing  111   b , and back to the patient via venous access tubing  111   a  attached to the blood outlet side  110   b  of the dialyzer  119 . Dialyzer holder  10  secures dialyzer  119  with clips  122  configured to snap around the profile of the long axis of the dialyzer  119 . Dialyzer holder  10  has a rotation axis  131  enabling holder  10  and dialyzer  119  to rotate together about the rotation axis  131  for priming the dialysate side of dialyzer  119 , when the dialysate outlet port  110   d  must be placed above the dialysate inlet port  110   c  to allow any trapped air to evacuate the dialysate side of the dialyzer  119 . In operation, dialyzer  119  and dialyzer holder  10  rotates about rotation axis  131  until dialysate outlet port  110   d  is above dialysate inlet port  110   c , as shown in  FIG. 2 . 
         [0026]    Turning back to  FIG. 1 , dialyzer holder  10  additionally supports attachment of the venous chamber  180  by attaching the venous chamber to venous chamber holder  181  on dialyzer holder  10 . A hydrophobic vent  109  attached to the venous chamber  180  via administration line  185  permits gases to escape from venous chamber  180 . Additionally, administration line  185  can be configured to allow administration of a substance into the blood line. 
         [0027]      FIG. 2  shows dialysis machine  199  and dialyzer  119  system of  FIG. 1  in a dialysate side priming configuration. A dialyzer  119  is secured by a set of clips  122  on a dialyzer holder  10 . Clips  122  surround and grasp a portion of the circumference of the dialyzer to secure dialyzer  119  in the rotated position. Together dialyzer  119  and holder  10  are rotated counterclockwise  11  around axis  131 , towards the dialysis machine  199 , by more than 90 degrees off vertical. As shown in  FIG. 2 , dialysate outlet  110   d  of the dialysate side of dialyzer  199  is positioned above dialysate inlet side  110   c  and a volume of saline, sufficient to prime the dialysate side, is able to evacuate air  160  from the dialysate side of the dialyzer  119 . A venous chamber holder  181  attached to the dialyzer holder  10  rotates the venous chamber  180  with dialyzer  119 . 
         [0028]      FIG. 3  is a diagram of a dual-axis dialyzer holder  100 . Dual-axis dialyzer holder  100  has a dialyzer attachment member  120  configured to secure a dialyzer ( 119  in  FIG. 6A ) to a support member ( 151  in  FIG. 6A ) by support attachment member  140 . As shown, support attachment member  140  can clip onto a cylindrical support pole via a support clip ( 150  in in  FIG. 4 ), or to a dialysis machine ( 199  in  FIG. 1 ), or another support member. In operation, dialyzer attachment member  120  secures a dialyzer ( 119  in  FIG. 6A ) against curved face  123  with flex clip  122  applying pressure on a dialyzer (not shown) towards curved face  123  of dialyzer attachment member  120 . Additionally, when a dialyzer is secured by flex clip  122 , it is positioned along the curved dialyzer attachment member face  123  by dialyzer support member  121  configured to interface with an end of an attached dialyzer (not shown). As shown in  FIG. 3 , dialyzer attachment member  120  is able to rotate in one or both directions (clockwise and counterclockwise) about a second rotation axis  131  by being rotatably coupled to a rotation member  130 . Likewise, the rotation member  130  is rotatably coupled to the support attachment members  140 . Together, dialyzer attachment member  120  and rotation member  130  are able to rotate about support attachment member  140  at a first rotation axis  141 . 
         [0029]      FIG. 4  is an exploded view of the dual-axis dialyzer holder of  FIG. 3 , showing dialyzer support member  140 , rotation member  130 , and dialyzer attachment member  120  separated along their respective rotation axes  131 ,  141 . Dual-axis dialyzer holder  100  has dialyzer attachment member  120  configured to secure a dialyzer ( 119  in  FIG. 6A ) to a support member ( 151  in  FIG. 6A ) by support attachment member  140 . As shown, support attachment member  140  can clip onto a cylindrical support pole via support clip  150 . In operation, dialyzer attachment member  120  secures a dialyzer ( 119   FIG. 6A ) against curved face  123  with flex clip  122  configured to apply pressure on the dialyzer (not shown in  FIG. 4 ) towards curved face  123  of dialyzer attachment member  120 . Additionally, an attached dialyzer (not shown in  FIG. 4 ) is positioned along curved dialyzer attachment member face  123  by dialyzer support member  121  configured to interface with an end of an attached dialyzer (not shown in  FIG. 4 ). 
         [0030]    Continuing to refer to  FIG. 4 , rotation member  130  is rotatably coupled to support attachment members  140  and rotates about first axis  141 . The rotation member  130  further includes first female rotation interface  135  configured to attach dialyzer support member  140  via corresponding first male rotation interface  145  on dialyzer support member  140 . Likewise, dialyzer attachment member  120  is rotatably coupled to rotation member  130  and rotates about second axis  131 . The rotation member  130  includes second male rotation interface  134  configured to attach dialyzer attachment member  120  via corresponding second female rotation interface  124  on dialyzer attachment member  120 . Together, dialyzer attachment member  120  and rotation member  130  are able to rotate about support attachment member  140  at first axis  141 . 
         [0031]      FIG. 5  is a further exploded view of the dual-axis dialyzer holder of  FIG. 3 , showing internal elements  501 ,  502 ,  503 ,  504  that enable rotation about the first and second rotation axes. First outer coupling assembly  501  is positioned between first female rotation interface  135  of rotation member  130  and corresponding first male rotation interface  145  on dialyzer support member  140 . First outer coupling assembly  501  can include washers and bearing necessary to permit rotation of rotation member  130  with a dialyzer (not shown) attached to dialyzer attachment member  120 . First outer coupling assembly  501  can include one or more limit mechanisms to limit the available angular rotation of rotation member  130  and can include tension or resistance mechanism to enable dialyzer holder  100  to securely hold a dialyzer (not shown) attached to dialyzer attachment member  120  at arbitrary angles. First inner coupling assembly  502  is configured to fit inside first outer coupling assembly  501  and secures rotation member  130  to dialyzer support member  140  along a first axis  141 . First inner coupling assembly  502  can include a screw and corresponding washers to fasten rotation member  130  to a corresponding screw hole in first male rotation interface  145  of dialyzer support member  140 . 
         [0032]    Second outer coupling assembly  503  is positioned between second male rotation interface  134  of rotation member  130  and second female rotation interface  124  on dialyzer attachment member  120 . Second outer coupling assembly  503  can include washers and bearing necessary to permit rotation of dialyzer attachment member  120  with an attached dialyzer (not shown). Second outer coupling assembly  503  can include one or more limit mechanisms to limit the available angular rotation of dialyzer support member  120  and can include tension or resistance mechanism to enable dialyzer holder  100  to securely hold a dialyzer (not shown) attached to dialyzer attachment member  120  at arbitrary angles. Second inner coupling assembly  504  is configured to fit inside second outer coupling assembly  503  and secure the dialyzer attachment member  120  to rotation member  130  along second axis of rotation  131 . Second inner coupling assembly  504  can include a screw and corresponding washers to fasten dialyzer attachment member  120  to a corresponding screw hole in second male rotation interface  134  of rotation member  130 . 
         [0033]      FIGS. 6A-C  are diagrams of the operation of the dual-axis dialyzer holder  100  of  FIG. 3  with an attached dialyzer  119 . In  FIG. 6A , a dual-axis dialyzer holder  100  having embodiments of the present invention is shown attached to support pole  151  of dialysis machine stand  200  by way of support clip  150 . Flex clip  122  on dual-axis dialyzer holder  100  grasps dialyzer  119  and secures it to dual-axis dialyzer holder  100 . Dialyzer  119  is shown in an upright (e.g., vertical or substantially vertical) position. In  FIG. 6B  dual-axis dialyzer holder  100 , affixed to support pole  151 , holds dialyzer  119  with flex clip  122  in a position rotated 45 degrees about first axis  141 .  FIG. 6C  shows dialyzer  119  further rotated to prime the dialysate side of dialyzer  119 . As an example, dialyzer attachment member  120  and rotation member  130  can be rotated can be rotated about 45 degrees from vertical about first axis  141  and dialyzer attachment member  120  can be rotated about 55 degrees from the first axis  141  rotation position about second axis  131 , but other combinations are possible. In  FIG. 6C  the dialyzer  119  is rotated to a position 105 degrees from the position shown in  FIG. 6A  by way of a 55 degrees rotation of the dialyzer attachment member  120  with respect to the rotation member  130  about second axis  131 . The resulting position of the dialyzer is sufficient for priming the dialysate side of the dialyzer, as similarly seen in  FIG. 2 . Compared to the single axis solutions, the present dual-axis design permits priming a dialyzer closer to the dialysis machine stand  200  with less horizontal translation, resulting in shorter overall tubing length. In addition, because of the close proximity between the dialyzer  119  and the dialysis machine stand  200  enabled by the dual-axis dialyzer holder  100 , in some embodiments, the venous chamber (not shown) remains attached to the dialysis machine  199  during priming of the dialyzer  119 . 
         [0034]      FIGS. 7A-C  are photographs of the operation of the dual-axis dialyzer holder  100  of  FIG. 6  with an attached dialyzer  119  connected to a dialysis machine  199 . In  FIG. 7A  a dialyzer holder  100  is attached to support pole  151  by support attachment clip  150 . In  FIG. 7B  a dialyzer  119  is attached to the dual-axis dialyzer holder  100  of  FIG. 7A  by a flex clip  122 . The dialyzer  119  has a blood inlet port  110   a  and a blood outlet port  110   b  and a dialysate inlet port  110   c  and a dialysate outlet port  110   d.    
         [0035]      FIG. 7C  shows the dialyzer  119  rotated about axes  131  and  141  of the dual-axis dialyzer holder  119  to position the dialysate outlet port  110   d  above the dialysate inlet port  110   c , in order to remove air from the dialysate side of the dialyzer  119  and prime the dialysate side of dialyzer  119 . The rotation member  130  of the dialyzer holder  100  is rotated about 45 degrees with respect to the dialyzer support member  140  about the first axis  141  and the support pole  151  and the dialyzer attachment member  120  is rotated about 55 degrees with respect to the rotation member  130  about the second axis  131 . 
         [0036]    An example embodiment of the present invention relates to a method of priming a dialysis machine  199 . The method includes first, connecting a blood line ( 111   a - c  of  FIG. 1 ) to a blood side of dialyzer  119 , a dialysate line (not shown) to a dialysate side of dialyzer  119  as shown in  FIG. 7A . A peristaltic pump  198  on the blood line configured to pump blood through the blood side of the dialyzer pump loop, pumps a volume of saline through the blood line, thereby priming the blood line. Second, rotating the dialyzer  119  from an upright (e.g., vertical or substantially vertical) position for priming of the blood side of the dialyzer to a position more than 90° from the substantially vertical position for priming of the dialysate side of the dialyzer, as shown in  FIG. 7C , thereby allowing priming of the dialysate side of the dialyzer without disconnecting the blood side. Finally, pumping a volume of saline through the dialysate side of the dialyzer  119  in the rotated position to evacuate air from the dialysate side, and returning the dialyzer to a substantially vertical position as shown in  FIG. 7B  to begin a dialysis treatment. 
         [0037]    While this invention has been particularly shown and described with references to example embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.