Abstract:
An apparatus wherein the primary dye source is connected to a secondary dye source with sufficient safeguards, including at least one-way check valve and at least one stopcock between the primary dye source and the secondary dye source, to assure a sterile barrier between the primary and secondary dye sources so that less than the total amount of fluid can be transferred from the primary dye source in an amount sufficient to perform a cardiac catheterization procedure.

Description:
This application is a continuation of application Ser. No. 08/615,579 filed Mar. 12, 1996, now abandoned, which is a continuation of Ser. No. 08/261,551 filed Jun. 17, 1994, now abandoned, which is a continuation of Ser. No. 08/091,543 filed Jul. 14, 1993, now U.S. Pat. No. 5,334,170. 
    
    
     BACKGROUND OF THE INVENTION 
     Cardiac catheterization is an invasive procedure which exposes each patient undergoing the procedure and the vasculature of that patient to potential contamination, making sterility a high priority. Because of the risks of cross-contamination, most items used during the catheterization procedure are disposable. Indeed, certain items which it would be desirable to preserve are disposed of in the interest of maintaining patient-to-patient sterility. 
     For example, non-ionic contrast media or dyes used in a cardiac catheterization procedure are relatively expensive fluids, with costs typically exceeding $1.00 per milliliter (ml). In the current cath lab environment, non-ionic dye media is supplied to the lab in 150 ml containers which is, for the material provided, a standard container. However, a typical catheterization procedure uses anywhere from 80 to 120 mls. At the end of such procedure, the container of non-ionic contrast media is discarded and 30 to 70 mls of contrast media is also discarded with that container, resulting in a loss of 20 to 47 percent of the contents of that container. 
     In a major cath lab setting where dozens of such procedures are performed every day, the use of non-ionic contrast media over a years time can amount to upwards of one million milliliters of fluid. Thus, an apparatus which could preserve the sterility and integrity of the non-ionic contrast media stored in the container and eliminate waste could produce significant savings in a cath lab. The foregoing example would envision annual savings of $200,000 to $470,000 in a single significant cath lab situation. 
     Of course, simply saving non-ionic contrast media is not enough. The associated apparatus must maintain the sterile barrier between fluid container and patient and maintain that sterile barrier from patient to patient as well. 
     SUMMARY OF THE INVENTION 
     Accordingly, the present invention envisions apparatus wherein the primary dye source, or primary non-ionic contrast media container, is connected to a secondary dye source such as a metered burette, with sufficient safeguards including at least one one-way check valve and at least one stop cock between the primary dye source and the secondary dye source to assure that a sterile barrier exists between the primary dye source and the secondary dye source, so that fluid can be transferred from the primary dye source in an amount sufficient to perform a cardiac catheterization procedure. 
     Typically, the minimum amount of non-ionic contrast media required to perform a single cardiac catheterization procedure is in the range of 80 to 120 mls. Accordingly, the one-way check valve between the primary dye source and the secondary dye source permits 80 to 120 mls. of non-ionic contrast media to be released into the secondary dye source when the stop cock therebetween is opened. When the transfer of fluid between the primary fluid source and the secondary fluid source is complete, the stop cock is closed to cut of f the fluid transfer and to support the maintenance of a sterile barrier between the primary dye source and the secondary dye source. Should additional fluid be required during the procedure, the stop cock can be reopened to release through the one-way check valve an amount of fluid sufficient to complete the procedure while still maintaining the sterile barrier between the primary dye source and the secondary dye source. 
     During the cardiac catheterization procedure, fluid flow is from the secondary dye source through a fluid line connected by a catheter to the patient. Before the contrast fluid media is transferred from the secondary dye source to the patient, air bubbles in the contrast media are removed by returning aerated fluid in the line to the secondary dye source and venting the bubbles through a vent-to-air member provided in the secondary dye source, thereby preventing air bubbles from being introduced into the blood stream of the patient. The vent-to-air member prevents a partial vacuum in this retrograde movement application. The vent also discharges air entrapped in the fluid to the atmosphere, as well as replaces fluid with air as such fluid is transferred from the secondary fluid source to the patient. 
     Further, a sterile barrier is maintained during the cardiac catheterization procedure between the primary dye source and the secondary dye source by the one-way check valve therebetween and, on completion of the catheterization procedure, the secondary dye source can be disconnected from the primary dye source enabling the primary dye source to be connected to a next secondary dye source associated with a second procedure and a second patient. 
     In an alternate embodiment a pair of vented spikes may each be connected to a primary dye source with proper coupling means connecting the output of each of two primary dye sources to a single connector and then into a single secondary dye source. 
     The proposed apparatus as described herein eliminates the substantial waste of a relatively expensive non-ionic contrast media, but yet maintains a sterile barrier between primary and secondary dye sources so as to preserve the integrity and the sterility of the catheterization procedure for each patient undergoing the procedure. Further, the apparatus of the present invention enables the development and use of primary fluid source containers of various sizes and configurations to improve the versatility and the convenience of such containers, as well as to further minimize waste in the catheterization procedure. 
    
    
     A BRIEF DESCRIPTION OF THE DRAWINGS 
     The above described apparatus will be better understood when the drawings briefly described below are considered with the detailed description which follows. 
     FIG. 1 is a schematic diagram of the dye management system of the present invention showing a primary dye source, a secondary dye source and the connecting apparatus therebetween to preserve the sterility of the connection therebetween; 
     FIG. 2 is a detailed drawing of a preferred embodiment of the system displayed schematically in FIG. 1; and 
     FIG. 3 is an alternate embodiment of the system of FIG. 2 wherein each of a pair of vented spikes may be connected to a respective primary dye source, to be connected to the described tubing and then to a single secondary dye source. 
    
    
     DETAILED DESCRIPTION 
     The dye management system  10  of the present invention is best seen in FIG. 1 wherein the system  10  is shown in schematic form. The primary dye source  12  comprises the original container for the non-ionic contrast media used in a catheterization procedure. The primary dye source  12  is connected to a secondary dye source  16  by tubing  14 . In the preferred embodiment, the secondary dye source  16  is an in-line metered burette. Provided in the connecting tubing  14  between primary dye source  12  and secondary dye source  16  is a one-way check valve  18  and a stop cock  20 . Also provided is a disconnect  22 , such as a luer lock connector, between the stop cock  20  and the one-way check valve  18 . The disconnect  22  enables separation of the secondary dye source  16  from the primary dye source  12  without compromising the sterile barrier created between the primary dye source  12  and the secondary dye source  16  by the one-way check valve  18 . A slide clamp  23  is interposed between the primary fluid source  12  and the disconnect  22 . 
     Extending from the bottom of the burette  16  is a fluid line  24  which is connected by a suitable luer lock fitting  25  to a fluid input port  26  of a multi-port manifold  27 . Syringe  28  is connected to a syringe port  29  of the manifold  27 . A throughport line  30  of the manifold  27  connects the syringe port  29  to a catheter port  31  disposed on the manifold  27  opposite the syringe port  29 . Catheter  32  connects to the port  31  at a proximal end thereof and to the patient (not shown) at a distal end thereof. 
     The fluid input port  26  and the syringe port  29  are then opened to enable the syringe  28  to retract and draw contrast media from the burette  16  into the syringe. Fluid line  24  can be debubbled by depressing the syringe  28  with the fluid input port  26  and the syringe port  29  open to return air bubbles through the fluid line  24  and back into the in-line burette  16 . A vent  33  enables the burette  16  to vent air returned thereto via fluid line  24 . Once the fluid line  24 , the manifold  27  and the syringe  28  have been primed to remove all air therefrom, the syringe is filled with sufficient contrast media (10-12 mls) to conduct a first phase of the cardiac catheterization procedure. The vent  33  of secondary dye source  16  also enables the user to replace the fluid being transferred from the in-line burette  16  to the patient with air, thus to prevent a partial vacuum from occurring in the fluid line  14  between the primary dye source and the secondary dye source. The cardiac catheterization procedure is multiple injection procedure, wherein the end position of the catheter in the patient&#39;s heart is changed prior to each fluid injection of 10-12 ml, to enable multiple pictures of various portions of the patient&#39;s cardiovascular system during the cardiac catheterization procedure. 
     The preferred embodiment of the dye management system  10  of the present invention is shown in FIG.  2 . In the preferred embodiment of FIG. 2 an administration set  113  connects the primary dye source  112  to a secondary dye source, an in-line burette  126 . Administration set  113  has provided at a proximal end thereof a vented spike.  114 . In the preferred embodiment primary dye source  112  comprises a standard 150 milliliter (ml) container of non-ionic contrast media. In alternative configurations permitted by the dye management system of the present invention, the standard 150 ml glass container can be replaced by a 100 ml glass container, or by plastic bags containing the dye, such bags ranging in size from 100 to 200 mls or larger. Container sizes in excess of 150 mls particularly emphasize the advantages of the dye management system of the present invention, since the present system not only effects direct savings of dye in the cath lab, but also enables the manufacturer to reduce packaging costs by enabling them to package and sell dye in the larger containers. 
     The primary dye source  112  has connected thereto the vented spike  114  which connects a fluid line  116  to the primary dye source  112 . A one-way check valve  118  is connected at its proximal end to the fluid line  116  And connected to a second fixed tubing section  119  at a distal end thereof. An adjustable clamp  117 , for example, a slide or roller clamp, is provided on the fluid line  116  between the spike  114  and the one-way check valve  118 . 
     The tubing section  119  includes at a first end a female luer lock connector  120  bonded to the distal end of one-way check valve  118  and at an opposite end a male luer lock connector  121 . A slide clamp  122  is received on the fixed tubing section  119 . A third removable tubing sect ion  124  having respective female and male luer lock connectors  124   a,    124   b  at opposite ends is connected at one end to fixed tubing section  119  and at an opposite end to a proximal end of a stop cock  125 . 
     The stop cock  125  is connected to burette tubing  127  of the in-line burette  126  at the proximal end thereof. The proximal end of burette tubing  127  includes a female luer lock connector  127   a  which is connected to the distal end of the stop cock  125 . The distal end of burette connector tubing  127  is fixedly connected to the burette  126  at burette input tube  128  in an upper wall  130  of the burette. 
     The in-line burette  126  is a cylindrical member having a top wall  130 , a bottom wall  131  and cylinder  132  therebetween, with metering indicia  129  provided on the cylinder  132  to enable the user to easily measure the amount of non-ionic contrast media transferred from the primary fluid source  112  through administration set  113  into the burette  126 . 
     On the upper wall  130  of the burette  126  is also provided a vent-to-air member  132  which includes a tubing section  132   a  and a filter element  132   b.  Mounted on tubing section  132   a  is a slide clamp  134 . An injection port  135  is also provided on the upper wall  130  of the burette  126 . 
     On the bottom wall  131  of the burette  126  is provided a central outlet defined by a short section of PC tubing  136  which is molded in place. A male luer lock connector  136   a,  provided at the distal end of the tubing  136  engages female connector  137  which extends from a proximal end of burette distal tubing  138  which extends between the lower end of the burette  126  and a manifold  140 . 
     Fluid line  138  carries on its distal end a male luer lock connector  139  which is connected to a fluid input port  141  of a multi-port manifold  140 . The manifold  140  includes a syringe port  142 , a through-put line  143  and a catheter port  144 . The manifold  140  also includes input ports  145  and  146 , which need not be discussed in detail here. 
     A manual syringe  147  is connected to the syringe port  142  at one end of through-put line  143 . A catheter  148  is connected to catheter port  144 , which is at the opposite end of through-put line  143 . Conventional manifold plumbing enables opening and closing of the above-described manifold ports in the sequence described in greater detail below. 
     An adjustable roller clamp  150  is provided on fluid line  138  between in-line burette  126  and the manifold  140 . 
     In operation, the administration set  113  functions as follows. 
     To enable fluid flow from the primary dye source or primary container  112  to the secondary dye source or in line burette  126 , a first adjustable roller clamp  117  mounted on fluid line  116  is opened and the slide clamp  122  on the fixed tubing section  119  is also opened. Then the stop cock  125  is opened to admit fluid through the tubing section  116 , the fixed tubing section  119 , the removable tubing section  124  and the burette tubing  127  to admit the non-ionic contrast media into the burette  126 . Fluid flow through the administration set  113  is continued until non-ionic contrast fluid media is transferred into the in-line burette  126  in an amount sufficient to conduct a cardiac catheterization procedure (80 to 120 mls). 
     At this point, the adjustable clamp on tubing section  116  is closed to prevent further flow of fluid from the primary dye source  112  into the in-line burette  126 . Next the slide clamp  122  carried on the fixed tubing section  119  is closed and then the stop cock  125  is closed to prevent further non-ionic contrast media from being transferred from the primary dye source  112  to the secondary dye source or in-line burette  126 . During the fluid transfer procedure, the user can readily measure the amount of fluid being transferred to the in-line burette  126  through use of the metering indicia  129  provided on the in-line burette. 
     During the loading of the in-line burette from the primary fluid source  112 , vented spike  114  admits air to the primary fluid source  112  to prevent a partial vacuum from occurring in the primary fluid source by replacing fluid removed therefrom with air taken in through the vented spike  114 . With clamps  117 ,  122  and the stop cock  125  closed, no further fluid can be passed into the in-line burette  126  and the system is ready to dispense the fluid from the burette to the catheter  148  attached to the patient. 
     To pass fluid from the in-line burette  126  to the patient, the adjustable roller clamp  150 , fluid input port  141 , and rotator port  142  are opened to enable fluid to travel from the in-line burette  126  through set tubing  138  through fluid input port  141  and syringe port  142  of manifold  140 . Fluid is drawn from the in-line burette  126  by retracting the syringe  147  connected to the syringe port  142  of the manifold  140 . Fluid flow is from the in-line burette  126  through tubing  138  through the fluid input port  141  through syringe port  142  and into the syringe  147 . 
     Set tubing  138  is primed to enable removal of air from tubing  138  prior to fluid transfer from in-line burette  126  to the manifold  140 . With the fluid input port  141 , the syringe port  142  open, fluid can be returned through set tubing  138  and into burette  126  by extending the syringe to the closed position to return air-in-line to the burette  126  which vents such air through the vent-to-air member  132 . 
     Once the fluid line  138 , the manifold  140  and the syringe  147  have been primed to remove all air therefrom, the syringe is filled with sufficient contrast media (10-12 ml) to conduct a first phase of the cardiac catheterization procedure. The fluid input port  141  may be closed to prevent further ingress of contrast media to the manifold  140 . With the fluid input port  141  closed, through-put line  143  is opened thereby enabling fluid flow from the syringe  147 , through the manifold  140 , through the catheter  148  and into the patient. The cardiac catheterization procedure is a multiple injection procedure, wherein the end position of the catheter in the patient&#39;s heart is changed prior to each fluid injection of 10-12 ml, to enable multiple pictures of various portions of the patient&#39;s cardiovascular system during the cardiac catheterization procedure. During the fluid transfer from the in-line burette  126  to the catheter  148  connected to the patient, the slide clamp  134  is opened to enable the vent-to-air member  132  to admit air to the in-line burette  126  while fluid is drawn therefrom to assure that no partial vacuum is created either in the inline burette or in the fluid line between the primary dye source and the secondary dye source during the period of fluid withdrawal. 
     The slide clamp  134  is also engaged if the catheterization procedure is interrupted while contrast media remains in the burette to prevent fluid flow out of the burette  126  through the vent  132  during the interruption in such procedure. 
     When the procedure is complete, slide clamp  122  is closed, and the burette assembly distal of fixed tubing section  119  is separated from the administration set  113 . The separated assembly remains intact for disposal and includes removable tubing section  124 , stop cock  125 , burette tubing  127 , in-line burette  126 , set tubing  138 , the manifold  140  and the syringe  147 . A sterile vented cover  231  (see FIG. 3A) is then placed over the male luer lock connector  121  of the fixed tubing section  119  to maintain the sterility of the primary dye source  112  until a second new sterile burette assembly which would include the removable tubing section  124  and all associated disposable components as enumerated above can be attached thereto to enable the primary dye source  112  to be used in a second procedure with another patient. 
     Alternative Embodiment 
     An alternative embodiment of the present invention is shown in FIG. 3, wherein a pair of primary fluid sources  212  each receive a vented spike  214  of an administration set  213  provided at the proximal end of tubing  216 . At the distal end of each tubing set  216  is provided female adapter  218 , which connects each tubing set  216  to a one-way stop cock  220  to which is fixedly connected to a tubing section  222  by means of a male luer lock connector  221 . 
     At respective distal ends thereof, each tubing section  222  is received in the proximal end of a two way connector  224 . Tubing section  225  connects the distal end of the connector  224  to the proximal end of a one-way check valve  226 . A female luer lock adapter  228  is received into the distal end of the one-way check valve  226  to connect tubing section  229  to the check valve  226  at one end. 
     A sterile vented cover  231 , shown in greater detail in FIG. 3A, is connected to male luer lock connector  231  to provide a sterile barrier for administration set  213  prior to use. After the cover  231  is removed, male luer lock connector  230  is joined to female luer lock connector  124   a  of removable tubing section  124  of an in-line burette  126  and related assembly as set forth above. 
     In all respects the connections to administration set  213  from the removable tubing section  124  to the in-line burette  126  and thereafter to the patient are the same as the connections distal to tubing section  119  shown in FIG.  2  and need not be discussed in detail here. 
     To deliver non-ionic contrast media or any other fluid to the patient with the apparatus of FIG. 3, fluid flow from one of primary fluid sources  212  is initiated by opening one of the one-way stop cocks  220  to admit fluid through respective lines  216  and  221 , to the connector  224 . The one-way check valve  226  carries fluid through lines  225  and  229  to the fluid line  124 , stop cock  125 , burette line  127  and into the in-line metered burette  126 . 
     While the apparatus described herein constitutes a preferred embodiment of the invention, it is to be understood that the invention is not limited to this precise apparatus and that changes may be made without departing from the scope of the invention, which is defined in the appended claims.