Patent Document

This application is a contiuation of Ser. No. 09/004,437 filed Jan. 8, 1998 now U.S. Pat. No. 6,158,467. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a stopcock for use in intravenous injections and infusions, and more particularly to a stopcock having four fluid flow ports and providing four ways for fluid to flow, including two fluid flow paths capable of flowing simultaneously. 
     BACKGROUND OF THE INVENTION 
     A stopcock is a cock or valve for stopping or regulating the flow of a fluid (wherein the term “fluid” as used herein may include liquids and/or gasses). In medicine, a stopcock is most typically used for regulating the flow of intravenous (“IV”) fluids or medications into, or out of, a patient as part of an intravenous system. A stopcock can also be used to divert fluids or air into devices, such as for filling skin expanders with fluid or air during skin grafting, for filling breast implants with saline during breast augmentation procedures, for diverting spinal fluid into a manometer to measure spinal fluid pressure during a spinal tap, and for diluting viscous packed red blood cells with saline to make them less viscous for subsequent rapid infusion into the patient during transfusions. 
     Stopcocks have been in use in the practice of medicine for intravenous injection and infusions for more than 30 years. They provide a quick and sterile way for diverting intravenous fluid flow or medication into a patient by changing the flow path in the IV line system. 
     In the past six years, stopcocks have been used with increasing frequency as a needle-less intravenous injection port. That is, once the initial IV injection port has been opened using a first needle, subsequent injections and infusions are possible through the same injection port via a stopcock having three ports separated by a shut off valve. Stopcocks provide an inexpensive method of avoiding needle-stick injuries and for a clinician to comply with the FDA mandate “to use needle-less injection techniques whenever possible”. 
     The first stopcocks used in medicine were made out of metal. They were re-sterilized and used on other patients. With the refining of plastic injection molding techniques, inexpensive, disposable plastic stopcocks have become the state of the art. They are disposed of after use on a single patient. The disposable plastic stopcock is cost effective and helps prevent spread of diseases between patients. 
     Early stopcocks were simply used as “on and off” valves to start or stop intravenous infusions. They contained two ports, an inlet port and an outlet port, which were placed in a straight line. There was a shut off lever in the middle of the two ports, and fluid flowed one way. These first stopcocks were designated as two-port, one-way stopcocks. 
     Another prior art stopcock has a body with three ports which are arranged in a T-shaped configuration, and a core having a lever and an axial portion. The channels and ports can be selected at the option of the user by rotating the lever to a position determined by the direction of flow desired. There is a “stop” tab on the body part of these stopcocks which prevents the lever of the stopcock from being turned to a position where all three ports are open and flow into one another at one time, i.e., such that the T-shaped path of the body and the T-shaped path of the core are fully aligned. Because fluid can flow three different ways, these stopcocks are designated as three-port, three-way stopcocks. 
     Referring to FIG. 1A, the prior art stopcock  2  is a three-port, four-way stopcock. It does not have a stop tab as in the three-port, three-way stopcock to prevent the lever from being turned to a position opposite the right angled port. The stopcock  2  includes a body  4  having an entry port  6 , an exit port  8  and an injection port  10 , and a core  12 . The body  4  and the core  12  are molded as two separate parts and press-fit together to make a completed three-port, four-way stopcock  2 . The core  12  includes a rotating axial portion  14  connected to a lever  16 . 
     Referring to FIG.  1 B and FIG. 1C, the axial portion  14  of the core  12  has a first flow channel  18 , a second flow channel  20  and a third flow channel  22  which form a confluent “T” configuration. The lever  16  generally includes the word “off”  24  and an arrow  26  molded on its upper surface to show which direction fluid will not flow. The arrow  26  and the word “off”  24  do not directly indicate to the user which way the medication or fluid will flow. 
     The three-port, four-way stopcock  2  is a four-way stopcock because fluid can flow in four different ways. First, when the lever  16  points toward the entry port  6 , fluid can flow between the injection port  10  and exit port  8 . Second, when the lever  16  points toward the injection port  10 , fluid can flow between the entry port  6  and exit port  8 . Third, when the lever  16  points toward the exit port  8 , fluid can flow between the entry port  6  and injection port  10 . Finally, when the lever  16  points opposite the injection port  10 , i.e., toward no port, fluid can flow between all three ports  6 ,  8 ,  10  at one time. 
     Referring to FIG. 2, the body  4  of the three-port, four-way stopcock  2  is molded as one piece. The entry port  6 , exit port  8  and injection port  10  are located in a single horizontal plane and are confluent at a central chamber  28 , which is filled with the axial portion  14  of the core  12  when the stopcock  2  is assembled. The entry port  6  has a female luer lock connector  30  and is the main fluid entry end of the stopcock  2 . It usually is connected to a male luer-lock connector  32  from an IV set connected to a bag of IV fluid. The exit port  8  has a male luer lock or luer slip connector  32  and is the fluid exit end of the stopcock  2  and is usually connected to a female luer lock connector  30  of an IV extension set which ultimately connects to the IV catheter in the patient. The injection port  10  protruding perpendicularly from the middle of the straight line flow path formed by the entry port  6  and exit port  8  has a female Luer lock connector  30  and is used for adding medication or fluids to the IV system. 
     Referring to FIG. 3, the axial portion  14  and the lever  16  are molded as one piece in a right angle configuration to form a completed core  12 . The lever  16  rotates in a horizontal plane which is parallel to the horizontal plane formed by the three fluid flow ports  6 ,  8  and  10 . 
     The procedure a clinician must follow to perform a typical IV injection or infusion using a conventional three-port, four-way stopcock  2  is fraught with difficulty and risk. An examination of this procedure makes clear the need for an improvement, such as that of the present invention described further below. 
     A typical intravenous setup using a three-port, four-way stopcock  2  has the exit port  8  typically connected to an IV extension tubing which is subsequently connected to an IV catheter in the patients vein. The entry port  6  is connected to a main IV administration set which is in turn connected to a bag of IV fluid, and the injection port  10  normally has a syringe or a secondary IV fluid line connected to it. When a syringe is attached to the injection port  10 , the bulk and length of the syringe requires that the syringe-stopcock assembly sit on a surface wherein a single plane is formed by the slow ports  6 ,  8 ,  10  of the stopcock  2  and the attached syringe. The axial portion  14  then extends vertically upward from, and the lever  16  rotates in a plane parallel to, that surface. To turn the lever  16  in a desired direction, a first hand of a clinician is held palm up in a horizontal plane, with the fingers pointing upward in a vertical direction, to stabilize the syringe-stopcock assembly, and a second hand of the clinician is held above the lever  16 , with fingers pointing in a downward, vertical direction, for grasping and rotating the lever  16 . 
     This arrangement is awkward for the clinician. With the first hand below and the second hand above the stopcock  2 , the clinician must first determine which way to turn the lever  16  to obtain the desired fluid flow, and then he or she must turn it in the correct direction, either clockwise or counter-clockwise, with fingers of the second hand. When the clinician is assured that the stopcock is secure in the grasp of the first hand only, the second hand releases the lever  16  and grasps the barrel of the syringe attached to the injection port  10 . The second hand then pushes or pulls the plunger of the syringe to give an injection of medication or to aspirate fluid. The second hand must next move from the syringe barrel back to its previous position grasping the lever  16  of the stopcock  2  and rotating it back to its original position. This procedure is cumbersome and time consuming, and involves twice moving one hand between two perpendicular planes. 
     Referring to FIG. 4, there is shown another prior art stopcock. This stopcock is designated a four-port, three-way stopcock  34 . Fluid can flow in three different ways. First, the fluid may flow between an entry port  36 , an exit port  38 , and a first lateral port  40 , simultaneously. Second, fluid may flow between the entry port  36 , exit port  38  and second lateral port  42  simultaneously. Third, fluid may flow between the entry port  36  and exit port  38  only. The stopcock  34  comprises a body  44  assembled with core  46 . The core  46  has an axial portion  48  and a lever  50 . The axial portion  48  sits partially inside a central chamber  52  of the body  44  and includes the entry port  36 . The body includes the exit port  38 , first lateral port  40  and second lateral port  42  which, together with the entry port  36 , are confluent to the central chamber  52  such that the body  44  and the core  46  form an air-tight and a fluid-tight connection. The central chamber  52  is only partially filled with the axial portion  48  of the core  46  when the stopcock  34  is fully assembled. The axial portion  48  enters the body  44  through an opening opposite the exit port  38 . 
     Referring to FIGS. 5A &amp; 5B, the core  46  of the four-port, three-way stopcock is smaller in diameter, and shorter, than the body  44  of the stopcock  34 . The lever  50  is built around the axial portion  48  about a third of the way down from its top end  54 . The axial portion  48  is vertical and has a hollow cavity  55  at its center extending down its entire length. The axial portion  48  has a female luer connector  30  connected to its top end  54 . A groove  56  is carved into the outer surface of the axial portion  48 , beginning at its bottom end  58  and going about one third of the way up its length. An arrow-shaped end  60  of the lever  50  points in the direction that the groove  56  faces. The groove  56  is separated from the hollow cavity  55  by a remaining thickness of material comprising the axial portion  48 . 
     Referring back to FIG. 4, the axial portion  48  does not extend to the bottom of the central chamber  52 . Thus, there is a small spacing  62  between the bottom of the central chamber  52  and the bottom end  58  of the axial portion, where the groove  56  begins. This spacing and the groove allow fluid to flow between the entry  36 , exit  38  and either the first  40  or second  42  lateral ports, simultaneously, if the lever is pointed toward one of the two lateral ports  40 ,  42 . If not, fluid merely flows between the entry  36  and exit  38  ports. 
     The four-port, three-way stopcock  34  has many drawbacks. First, it lacks the ability to selectively direct IV medications and IV fluids to specific ports and subsequently, to specific parts of the IV system. When the lever  50  is turned toward either of the lateral ports  40 ,  42 , fluid flows between the entry  36 , exit  38  and either one of the lateral ports  40 ,  42 , simultaneously, instead of selectively between any two ports. Second, because of the design of the stopcock  34 , fluid cannot be directed to flow between the lateral ports  40  and  42 . Third, only one continuous flow path can run through the stopcock  34  at one time. Finally, fluid cannot be selectively, and specifically, diverted from either the entry  36  or exit  38  ports to either lateral port  40 ,  42  because the fluid flow path between the entry  36  and exit  38  ports cannot be shut off, i.e., some fluid will always flow between the entry  36  and exit  38  ports. 
     SUMMARY OF THE INVENTION 
     The present invention provides a stopcock having two components, a body and a core, that are assembled together and form a fluid-tight and air-tight seal. The body has a number of connectable ports attached to a central chamber. The core has an axial port and is positioned within the central chamber so that it can be rotated with respect to the body. The core also has two separate, non-communicating fluid passages that can carry fluid between two different sets of ports, simultaneously. For example, the core can be rotated to a position wherein one fluid flows between the axial port of the core and one of the connectable ports of the body, while another fluid simultaneously flow between two other connectable ports of the body. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1A is a top view of a prior art three-port, four-way stopcock. 
     FIG. 1B is a cross-sectional/top view of the T-intersection flow path of a core of a prior art three-port, four-way stopcock. 
     FIG. 1C is a top view of the lever part of a prior art core of a three-port, four-way stopcock. 
     FIG. 2 is a top view of a body of a prior art three-port, four-way stopcock. 
     FIG. 3 is a side view of a core of a prior art four-way, three-port stopcock. 
     FIG. 4 is a cross-sectional/front view of a prior art four-port, three-way stopcock. 
     FIG. 5A is side view of a core of a prior art four-port, three-way stopcock. 
     FIG. 5B is a cross-sectional/top view of a prior art core of a four-port, three-way stopcock. 
     FIG. 6 is a perspective view of a four-port, four-way stopcock of the present invention. 
     FIG. 7A is a cross-sectional/top view of a core of a four-port, four-way stopcock of the present invention, taken along the line  7 A— 7 A. 
     FIG. 7B is a side view of a core of a four-port, four-way stopcock of the present invention. 
     FIG. 7C is a top view of the lever of a core of a four-port, four-way stopcock of the present invention. 
     FIG. 8 is a perspective view of a typical IV setup utilizing all four ports and two separate flow paths simultaneously of a four-port, four-way stopcock of the present invention. 
     FIG. 9 is a perspective view of another embodiment of a four-port, four-way stopcock of the present invention. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to FIG. 6, a four-port, four-way stopcock  70  of the present invention comprises a body  72  and a core  74 . In a preferred embodiment, the body  72  is substantially similar to the body  4  of the three-port, four-way stopcock of FIG.  2 . The body  72  includes a main entry port  76 , a main exit port  78  and a secondary entry port  80 , each being confluent to a central chamber  82 . The core  74  has an axial portion  84 , an axial port  96  and a lever  86 . In a preferred embodiment, the main entry port  76  has a female luer lock connector  30 , the main exit port  78  has a male luer lock or luer slip connector  32  and the secondary entry port  80  has a female luer connector  30  attached to its end. In another embodiment (shown in FIG.  9 ), port  80  may have a male luer lock or luer slip type connector. 
     Referring to FIGS. 7A and 7B, the axial portion  84  of the core  74  includes a first channel  88 , a second channel  90 , a third channel  92  and an axial flow channel  94 , which ends at the opening of the axial port  96 . The first channel  88  and third channel  92  are open to one another, as are the second channel  90  and axial flow channel  94 . Neither the first channel  88  nor third channel  92  is open to either the second channel  90  or axial flow channel  94 , and vice-versa. The second channel  90  opens in the direction in which the lever  86  points. The openings of channels  88 ,  90  and  92  are all on the same horizontal plane of the core  74 . 
     Referring to FIG. 7B, the second channel  90  is shorter than the first channel  88  and third channel  92  and does not intersect them. Instead, a remaining thickness of core material separates the fluid flow path defined by the confluent first channel  88  and third channel  92 . 
     The axial portion  84  further includes an axial port  96  which opens vertically above the lever  86 . In a preferred embodiment, the axial port  96  includes a female luer-lock connector  30 . The axial flow channel  94 , which opens at the axial port  96 , is not entirely vertical, but is positioned at an acute angle to vertical such that it connects the axial port  96  with the shortened second flow channel  90 , yet avoids connection, or communication, with the fluid flow path formed by the first channel  88  and the third channel  92 . 
     The four-port, four-way stopcock  70  of the present invention features two independent fluid flow paths through its core  74 . A main fluid flow path is formed by the first channel  88  and third channel  92 , and a secondary fluid flow path is formed by the second channel  90  and the axial flow channel  94 . 
     When the core  74  is press-fit assembled to the body  72 , the four-port, four-way stopcock of the present invention is complete. The two press-fit parts combine to make an air-tight and a fluid-tight seal. 
     As the lever  86  is rotated, thereby rotating the core  74 , the second flow channel  90  opens in a new direction equal to the direction into which the protruding lever  86  extends. Flow is enabled between the axial port  96  and either the main entry port  76 , main exit port  78  or secondary entry port  80  via the axial flow channel  94  when the lever  86  is pointing towards one of these respective ports. 
     There are four positions of the lever  86  which provide four useful ways for fluid to flow through the stopcock  70 . First, when the lever  86  is turned to point in a direction opposite the secondary entry port  80 , medication or fluid, such as a syringe or a secondary IV line, attached to the axial port  96  cannot flow because the second flow channel  90  is blocked, as there is norort extending in that direction to accommodate flow. The main fluid flow path is, however, enabled for flow between the main entry port  76  and main exit port  78 . Second, when the lever  86  is pointed toward the secondary entry port  80 , flow is enabled between the axial port  96  and the secondary entry port  80 , as well as between the main entry port  76  and exit port  78 , simultaneously. Thus, two independent fluid flow paths through the stopcock  70  are enabled and all four ports are being utilized at the same time. Third, when the lever  86  is pointed toward the main entry port  76 , flow is enabled between the axial port  96  and the main entry port  76 , no other ports being enabled. Likewise, and finally, when the lever  86  is pointed toward the main exit port  78 , flow is only enabled between the axial port  96  and the main exit port  78 . 
     Both aspiration, or flow to the axial port  96 , and infusion, or flow from the axial port  96  are possible in conjunction with any of the three horizontal ports  76 , 78 , 80 . A clinician has the additional option of using the secondary entry port  80  for infusion or aspiration with the axial port  96 , while at the same time enabling flow between the main entry port  76  and main exit port  78 . 
     Referring to FIG. 7C, the lever  86  has an arrow  98  on its upper surface pointing in a direction in which the lever  86  protrudes. The lever  86  further has the word “ON”  99  written on its upper surface to indicate to the user which way the fluid will flow from or to the axial port  96  into or out of the second flow channel  90 . The lever  86  will always point to the specific port that fluid or medication to/from a syringe or secondary IV line attached to the axial port  96  will flow. A clinician can thus immediately know where fluid to or from the axial port  96  will flow. 
     The improved stopcock of the present invention has the advantage that it has four-ports and can support fluid flow in four different and useful ways. Also, the flow ports are located in two separate planes, three  76 , 78 , 80  associated with the body  72  in a single horizontal plane and the axial port  96  of the core  74  extending vertically upwards. Prior art devices restrict the possible choices of orientation of the stopcocks and attached medical devices. An additional advantage of the four-port, four-way stopcock  70  of the present invention is that two independent fluid flow paths can be simultaneously enabled. This is not possible with the prior art stopcocks  2  (shown in FIG.  1 A),  34  (shown in FIG.  4 ). 
     An important clinical situation where the ability to run two separate fluid paths through a stopcock simultaneously would be used, is during blood transfusion. Blood transfusion is a common procedure during surgery and in the post operative care units. Blood is usually obtained from the blood bank in the form of packed red blood cells. The packed red blood cells from the blood bank are cold, and they are a very viscous solution. Packed red blood cells are obtained by separating the fluid plasma from the cells of the whole blood, by centrifuging the blood after the blood has been taken from the donor. The separated blood components are stored in the refrigerator, in the blood bank, to prolong their shelf life. The cold, viscous, packed red blood cells are frequently diluted with saline solution, by the clinician before transfusing them into the patient, to make them less viscous and to warm them up. A warm, and less viscous, solution of red blood cells will flow through an IV system much faster than will a viscous solution of cold packed red blood cells. The ability to transfuse blood rapidly is important when blood must be transfused into a patient as fast as possible to preserve the patient&#39;s vital signs. 
     Referring to FIG. 8, with the four-port, four-way stopcock  70  of the present invention, the main fluid flow path between the main entry port  76  and main exit port  78  can be used as the main IV line to infuse fluids and medications into a patient, while the secondary fluid flow path between the axial port  96  and secondary entry port  80  can be used to dilute the packed red blood cells. To perform this simultaneous procedure, the lever  86  is first turned to point opposite the secondary entry port  80 . This is the “off” position for the axial port  96  because there is no flow port opposite the secondary entry port  80 . In this position, medication is now flowing from a main IV set connected to the main entry port  76 , through the first channel  88  and the third channel  92 , through the main exit port  78 , to the IV extension set connected to the IV catheter in the patient. 
     A bag of saline solution to be used for diluting the packed red blood cells is next attached to a secondary IV set, and a male luer connector  32  of the secondary IV set is attached to the female luer connector  30  of the secondary entry port  80 . The bag of packed red blood cells is attached to a third IV set, and the male luer connector  32  of this third IV set is attached to the female luer connector  30  at the axial port  96 . After these connections are made, the saline bag is maintained at a level higher than the level of the bag of packed red blood cells. 
     The lever  86  is next turned to point toward the secondary entry port  80 . This enables the diluting saline solution to flow through the secondary IV set attached to the secondary entry port  80 , through the second channel  90  and axial flow channel  94 , out the axial port  96 , through the third IV set and into the bag of packed red blood cells to dilute the viscous packed red blood cells and make them warmer. Turning the lever  86  toward the secondary entry port  80  also permits continued flow through the main IV flow path, and continued therapy to the patient through the main IV line while the packed red blood cells are being diluted through the secondary fluid flow path. Both the main and secondary fluid flow paths of the stopcock  70  of the present invention are thus flowing simultaneously. 
     When the red blood cells attached to the axial port  96  have been diluted with the saline solution coming from the secondary entry port  80 , the lever  86  is next turned to point toward the main exit port  78 , and the diluted red blood cells can now flow from the bag of diluted red blood cells, through the third IV set attached to the bag of diluted red blood cells, into the axial port  96 , through the axial flow channel  94 , out of the main exit port  78  and into the patient. 
     This technique of red blood cell dilution and subsequent infusion into the patient is done with a simple twist of the lever  86  of the four-port, four-way stopcock  70 , and prevents any spillage of valuable blood cells or contamination of any fluids in the IV system. This uninterrupted, red blood cell dilution and transfusion procedure is easily, and sterilely, completed with the four-port, four-way stopcock  70  of the present invention because of the stopcock&#39;s ability to enable two separate flow paths at one time. 
     In another embodiment, the secondary entry port  80  would comprise a male luer slip or luer lock fitting. This is an ideal configuration for filling skin expanders or breast implants (which are typically equipped provided with an inflation tube having a female luer connector) with air or fluid from a syringe attached to axial port  96 . 
     CONCLUSION 
     From the foregoing description, it is believed apparent that the present invention provides a novel four-port, four-way stopcock for intravenous injections and infusions. It should be understood, however, that the invention is not intended to be limited to the specifics of the illustrated embodiments, but rather is defined by the accompanying claims.

Technology Category: 4