Abstract:
A fluid management system is disclosed which includes an injection device, a medical device, and a valve. The medical device is in fluid communication with the injection device. The valve is operatively associated with the medical device, and the valve includes a mechanism for slidably opening the valve.

Description:
FIELD OF THE INVENTION 
     The invention generally relates to medical devices and, more particularly, relates to devices for controlling fluid flow in an injection system. 
     BACKGROUND OF THE INVENTION 
     It is often necessary to open and close conduits in medical procedures. For example, in an angiographic procedure, at least one syringe is provided which draws from a supply of radiopaque contrast and injects the contrast through a catheter into the patient. The catheter may be connected directly to the syringe, or other equipment may be provided therebetween, such as a manifold or a y-adaptor. The y-adaptor may be provided to receive fluid from one or more sources to the same catheter or may be provided to provide one inlet for a manifold, and a second inlet for interventional devices. 
     Currently, y-adaptors include hemostatic valves to minimize blood loss from the patient. The hemostatic valve includes a cylindrical gland that is compressed by a collar to change the diameter of the gland. By inserting a catheter through the gland and then changing the diameter of the gland, the gland compresses the catheter sufficiently to provide hemostatis and fix the catheter into location. The compression of the gland by the collar is typically achieved by twisting a cap on the y-adaptor. The y-adaptor includes threads mated with threads provided on a body of the y-adaptor. As the cap is twisted onto the body, a cap moves toward the y-adaptor body and the collar is compressed. 
     Often, the cap must be turned several times, depending on the amount of compression required to achieve the desired seal. For example, during typical cardiology procedures using such y-adaptors, there are numerous times that physicians need to open or close the gland for intervention, removal and manipulation of each interventional device. Occasionally the y-adaptor is used to fix a catheter shaft into position. It is not uncommon for physicians to require more than one adjustment of the catheter. 
     Conventionally, passive valves (normally closed valves) are provided which can be forced open when adequate force is imparted against the valve element by the device being inserted. Currently, such passive devices may require relatively more force to be opened. 
     SUMMARY OF THE INVENTION 
     In accordance with one aspect of the invention, a fluid management system is provided which comprises an injection device, a medical device, and a valve. The medical device is in fluid communication with the injection device. The valve is operatively associated with the medical device and the valve includes a mechanism for slidably opening the valve. 
     These and other aspects and features of the invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a side view of an injection system constructed in accordance with the teachings of the invention; 
     FIG. 2 is an exploded view of a valve constructed in accordance with the teachings of the invention; 
     FIG. 3 is a sectional view of the valve of FIG.  2  and depicted in a locked position; 
     FIG. 4 is a sectional view of the valve of FIG.  2  and depicted in a released position; 
     FIG. 5 is a sectional view of an alternative embodiment of the invention and depicted in a closed position; 
     FIG. 6 is a sectional view of the alternate embodiment of FIG. 5, but depicted in an open position; and 
     FIG. 7 is an isometric cut-away view of a slitted gland constructed in accordance with the teachings of the invention. 
     While the invention is susceptible to various modifications and alternative constructions, certain illustrative embodiments thereof have been shown in the drawings and will be described below in detail. It should be understood, however, that there is no intention to limit the invention to the specific forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined by the appended claims. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring now to the drawings, and with specific reference to FIG. 1, an interventional system constructed in accordance with the teachings of the invention is generally depicted by reference numeral  20 . While the teachings of the invention will be described in conjunction with such an interventional system  20 , it is to be understood that the teachings of the invention can be employed in multiple other applications, wherever conduits need to be quickly and securely opened and closed. 
     As shown in FIG. 1, the system  20  includes an injection device  22 . The injection device  22  may be a manually operated syringe, but could be alternatively provided as by a power injection system as well. The depicted syringe  22  includes a cylinder  24  in which an operable plunger  26  is disposed for reciprocating motion. The syringe  22  includes an outlet  28  to which a manifold  30  is connected. The manifold  30  may be connected to multiple fluid supplies, such as, but not limited to, radiopaque contrast for use in conjunction with angiographic procedures. 
     A fluid supply line  32  extends from the manifold  30  and is connected to a y-adaptor  34 . The y-adaptor  34  includes first and second inlets  36 ,  38  and a single outlet  40 . A guide catheter  42  is connected to the outlet  40 , with a balloon catheter  44  within the lumen of the guide catheter  42  and extending from the introducer sheath  46  connected to the guide catheter  42  and through the first inlet  36  of the y-adaptor  34 . Upstream of the first inlet  36  is a balloon inflation port  48  on the balloon catheter  44  to which an inflation device  50  is connected. A guide wire  52  and torque device  54  also enter proximate the inflation port  48  for control of the balloon  56  of the balloon catheter  44 . 
     As can be seen from FIG. 1, a hemostatic valve  58  is positioned at the first inlet  36 . The valve  58  is able to open and close around a medical device, such as the balloon catheter  44 , extending therethrough in either a fast or slow fashion. For example, it may be advantageous to quickly open the valve  58  as when exchanging catheters or introducing stents or balloons. It would also be advantageous to provide a mechanism through which the valve  58  can be securely closed with an effective seal. It is to be understood that the medical device could be items other than catheters, such as guide wires and the like as well. 
     Turning now to FIGS. 2-4, the valve  58  is shown in further detail. The valve  58 , in one embodiment includes a body  60 , a gland  62 , a collar  64 , a cap  66 , and first and second half nuts  68   a  and  68   b . The body  60  includes a cylindrical head  70  in which first and second arcuate apertures  72   a  and  72   b  are provided. The body further includes an annular flange  74 , the importance of which will be further described herein. If more or less than two half nuts  68  are provided, a corresponding number of apertures  72  may be provided within the cylindrical head  70  of the body  60 . 
     The gland  62  is preferably manufactured from an elastomeric material and includes a substantially cylindrical outer surface  76  as well as a central bore  78 . 
     The collar  64  includes a central portion  80  provided with external threads  82  (FIGS.  3  and  4 ). The collar  64  further includes an enlarged diameter platform  84  and a driving end  86 . A central bore  88  extends through the collar  64 . 
     The first and second half nuts  68   a  and  68   b  include threads  90  (FIGS. 3 and 4) on an internal surface  92  thereof, as well as cam surfaces  94  provided on an external surface  96  thereof. 
     The cap  66  includes an interior surface  98  having a cam surface  100  positioned between an enlarged diameter area  102  and a reduced diameter area  104 . The cap  66  further includes a top surface  106  having an inlet  107  from which a tube  108  downwardly extends, as well as at least one drive shaft  110 . A radially inwardly directed lip  112  is provided at the base of the cap  66  and is adapted to slide on the body  60  between a shoulder  114 , and the annular flange  74 . 
     In alternative embodiments, the locations of the threads and cam surfaces may be different. For example, the interior surface  98  of the cap  66  may include threads (not shown) for engagement with threads on the exterior surface  96  of the nuts  68   a  and  68   b . In such an embodiment, cam surfaces could be provided on the internal surface  92  of the nuts  68   a ,  68   b  for cooperation with cam surfaces on the central portion  80  of the collar  64 . In so doing, the cap  66  may be rotated or slid relative to the remainder of the valve  58  for operation of the valve  58  in a secure close mode or a quick release mode, respectively. 
     In operation, if the valve  58  is positioned with the cap  66  in the position of FIGS. 2 and 3, the half nuts  68   a  and  68   b  are driven radially inwardly by the cam surface  100  of the cap  66 . Accordingly, the threads  90  and  82  are engaged. Since the drive shaft  110  is rotationally fixed to the collar  64  through a channel  116 , rotation of the cap  66  causes the collar  64  to rotate as well. Since the first and second half nuts  68   a  and  68   b  are axially fixed by the body  60 , rotation of the cap  66  in a first direction causes the collar  64  to axially advance in a first direction, with rotation of the cap  66  in the opposite direction causing the collar  64  to axially translate in the opposite direction. 
     When the collar  64  axially advances toward the gland  62 , the gland  62  is pushed against a land  117  of the body  60  and compresses, thereby exerting inward force on the catheter  44  provided through the valve  58 . If the collar  64  is advanced sufficiently, the gland  62  compresses sufficiently to complete the seal of the catheter  44 . 
     Since rotation of the cap  66  can be relatively time consuming, the valve  58  is further provided with a quick release feature. As can be seen from a comparison of FIGS. 2 and 3, if the cap  66  is axially slid toward the body  60 , the threads  82  and  90  become disengaged. Accordingly, the gland  62  is no longer compressed and can return to its normal position, opening the catheter  44 . The force of the expanding gland  62  pushes against the driving end  86  of the collar  64  to thereby push the collar  64  upward, and the first and second half nuts  68   a  and  68   b  radially outward, to the point of disengagement. In an alternative embodiment, a spring may be provided to assist the expansion motion by the gland  62 . 
     Referring now to FIGS. 5-7, an alternative embodiment of a valve is generally referred to by reference numeral  156 . Wherein like elements are employed in the alternative embodiment, like reference numerals are employed. A difference in the alternative embodiment is with regard to the gland  150 . As shown best in FIG. 7, the gland  150  includes a cylindrical base  152  having a top  154  across which a web  156  extends. A linear slit  158  is provided within the web  156 . The web  156  is preferably concave or bulbous and extends away from the cylindrical base  152 . 
     Another difference in the alternative embodiment is illustrated in FIGS. 5 and 6 wherein the valve  58  is shown to include a shuttle  160 . The shuttle includes an upper cap  162  from which an actuation conduit  164  downwardly extends. The actuation conduit  164  includes an inlet  166  and an outlet  168 . As can be seen in the comparison between FIGS. 5 and 6, the shuttle  160  can be moved between open and closed positions. In the open position, the shuttle  160  is downwardly depressed into the valve  58  thereby forcing the outlet  168  through the slit  158  of the gland  150 . In so doing, the gland  150  is held open with the web  156  surrounding the actuation conduit  164 . Accordingly, a pathway is created from the inlet  166 , through the actuation conduit  164 , and through the central bore  78  of the body  60 . In such an orientation, a device, such as a stent (not shown) or the balloon  56  may be easily inserted through the valve  58  without interference from the gland  150 . 
     Conversely, when the shuttle  160  is pulled away from the valve  58 , the actuation conduit  164  is pulled away from the gland  150  and the resiliency of the elastomeric gland  150  causes the web  156  to return to a closed position wherein the slit  158  is sealingly closed. A circumferential nib  170  may be provided on the cap  66 . In combination with a shoulder  172  and a radially inwardly directed lip  174  provided on the shuttle  160 , the circumferential nib  170  prevents the shuttle  160  from being fully retracted off of the valve  58 . 
     In operation, it can therefore be seen that the teachings of the invention can be used to construct the a fluid management system having a valve operable in secure close and quick release modes. This not only minimizes blood loss and accurate positioning of catheters, but allows for quick interchange of catheters as well.