Abstract:
A stopcock with a locking connector protective assembly for selectively controlling the passage of sterile medicinal fluids from a plurality of sources and comprising a body having a plurality of input arms with male or female locking connector tips, an output arm with a male locking connector tip, a rotor located inside the body and having a handle and rotatable about an axis in the body and having a rotor lumen and having channels or holes that may be aligned with the arm lumens as indicated by pointers. A self-sealing injection port is provided which covers the rotor lumen. A locking connector protective assembly is mounted on the input arms to prevent touch contamination and may be retrofitted to current stopcocks, and retained by the locking connector tip. A telescoping resilient coil variably expands to enclose the locking connector tip when the tip is not in use and retracts sufficiently to allow access to the locking connector tip for connections to a complementary locking connector tip. A rim at the proximal end of the coil has resilient locking tabs permitting installation over a locking connector tip flange, but resisting removal therefrom, and a lid that may be flipped off the rim for access to the locking connector tip and which is retained by a flexible lid retainer link connected to the rim.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates generally to a stopcock and more specifically to an improved stopcock and a protective assembly for connection of fittings on the stopcock and which may be retrofitted to current stopcocks. 
     Stopcocks are widely used to direct the flow of multiple compatible intravenous (IV) solutions into one IV line. A stopcock allows the user increased flexibility to select from among several input lines and various combinations of the above to run into the output line or to stop the IV flow altogether. It is advantageous to run multiple lines into one line because this can dilute out a particular drug that is irritating to patients and it can also decrease the need for multiple IV sites in a patient. 
     While IV stopcocks are widely used because of their advantages, they have several disadvantages. It is difficult to handle current stopcocks without touch contamination because of their small size with short connector arms that are unprotected from touch contamination. Another disadvantage of current stopcocks is because of the short handle lengths on the rotors that are turned to select the flow desired through the stopcocks. A further disadvantage is the small internal fluid passageways that restrict the flow of viscous fluids, especially blood. This can substantially increase the time it takes to infuse these fluids. Because of this, it may be necessary to utilize pumps to force the fluids through these restricted passageways. It is frequently necessary to push IV drugs through injection ports while the stopcock is in place. Therefore, the lack of an injection port on commercially available stopcocks may cause inconvenience or require additional IV lines to be placed in the patient. The placement of additional lines may cause the patient discomfort and may be difficult for healthcare workers, as well, because of the patient&#39;s physiological condition. Most stopcocks are of limited input capacity and have only two input arms and one output arm. This is frequently insufficient, so multiple stopcocks are required in combination to supply sufficient input line capacity. A single stopcock of greater input arm capacity is contemplated according to my invention so that multiple stopcocks are not required. One feature of the invention is a stopcock with connector arms having standard locking connector tips with a locking connector protective assembly over the female locking connector tips. Another feature is increased length of the arms and handle and increased capacity for input lines. A further feature may include input arms that contain a backflow check valve and that lie on a different plane than the other arms. 
     SUMMARY OF THE INVENTION 
     One embodiment of the present invention relates to an improved stopcock with a locking connector protective assembly. The stopcock has a body with a plurality of input arms that have male or female locking connector tips and an output arm with a male locking connector tip. A rotor is placed inside the body and has a handle which is used to rotate the rotor in the body. The rotor has a rotor lumen and channels for passage of fluids. A self-sealing injection port covers the rotor lumen. The arms and channels are located in the same plane as defined by the rotation of the channels in the rotor to permit the passage of fluids between the two. 
     A locking connector protective assembly is placed over the female locking connector tip and encloses the female locking connector tips. The assembly has a coil with a proximal and distal end. The proximal end of the coil has a closure with a lid and rim where the lid has means for covering the rim and is connected to the rim by a flexible lid retainer link. The rim also has means to secure the assembly to the locking connector tip. The distal end of the coil abuts the body of the stopcock. 
     A preferred embodiment of the invention has enlarged and lengthened arms and handle for improved operation and contains pointers to indicate to the user which lines are open and which lines are closed. The stopcock also has enlarged lumens to increase the flow of viscous fluids, decrease the need for pumps and also has a locking connector protective assembly which may also be retrofitted to stopcocks. In another embodiment of this invention, one or more self-sealing injection ports are included with the stopcock and cover the rotor lumen or may be attached via locking connectors to the arms of the stopcock. Further embodiments of this invention include a stopcock having an input arm with an integral back check valve to prevent back flow into the input line, and a stopcock with a bottom output arm. 
     One object of this invention is to prevent touch contamination of the locking connector tips. Another object of this invention is to simplify the operation of the stopcock by using longer arms and handles, providing self-sealing injection ports, providing larger stopcock lumens and channels and location stops. A further object of this invention is to allow retrofit of current stopcocks, other IV line connectors or adapters with the locking connector protective assembly. Related objects of the present invention are disclosed in the following description of the preferred embodiments. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a top view of a three limb stopcock with a locking connector protective assembly. 
     FIG. 2 is a side view of a three limb stopcock with the locking connector protective assembly omitted. 
     FIG. 3 is a bottom view of a three limb stopcock with a locking connector protective assembly and with the bottom of the stopcock body broken away to show the bottom of the rotor. 
     FIG. 4 is an enlarged top view of the locking connector protective assembly. 
     FIG. 5 is an axial view on the same scale as FIG. 4 showing the female locking connector tip of the FIGS. 1-3 embodiment with the protective assembly on it but the lid omitted for simplification of drawing. 
     FIG. 6 is a side view of a four arm stopcock with back flow check valve. 
     FIG. 7 is a side view of the rotor of the stopcock in FIG. 6. 
     FIG. 8 is a section of the rotor which illustrates the orientation of the groove to the handle. 
     FIG. 9 is a side view cut away diagram of a four arm stopcock with a back flow check valve and self-sealing concave injection port plug. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device and method, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. 
     FIGS. 1-3 illustrate a first embodiment of the present invention. The embodiment is shown in top, side and bottom view. The three arm stopcock 21 is illustrated with the locking connector Protective assembly 101. The stopcock has a body 23 with input arms 25 that have female locking connector tips 29, and an output arm 31 with a male locking connector tip 27. The arms have arm lumens 32 for passage of sterile fluids. A rotor 33 extending down inside the body 23 has a handle 35 which is used to rotate the rotor in the body. The rotor has a rotor lumen 37 from top to bottom and radial passageways 39 communicating with the lumen at the rotor bottom for passage of fluids. The passageways may be radial holes or channels as illustrated in FIG. 3. A self-sealing injection port plug 41 covers the top portion of the rotor lumen and provides needle access to the rotor lumen. The injection port plug is made from a pliable, needle-pierceable, self-sealing material and is similar to rubber stoppers that are used to cover vials of injectable drugs. The ends of the arms are located in the same plane as defined by the outer ends of the holes or channels in the rotor to permit the passage of fluids between the two. Pointers 43 are placed on the top of the rotor to indicate the selection of input or output lines connected to the stopcock. A car plug 30 is normally connected to the unused female locking connector tip and is constructed like a male locking connector tip 27, except that it has no lumen. A locking connector protective assembly 101 is placed over the female locking connector tip as shown in FIGS. 1 and 3 (and is omitted in FIG. 2 in order to show an end view of a female locking connector tip without the protector) and is shown in FIG. 4 in greater detail. 
     The rotor 33 is rotatable inside the body 23 by grasping the handle 35 and an input arm 25, an output arm 31 or the body 23 and turning the handle either clockwise or counter clockwise until the pointers 43 indicate the desired combination of input arms 25 and output arm 31 are open or closed to the flow of fluids. The handle may be turned so that all, none, or a portion of the input arm lumens are in communication with the lumen of the output arm. It is contemplated that the locking connectors shall be compatible with Luer Lok™ connectors. Standard male locking connector tips on input lines may be connected to female locking connector tips such as 29 on the stopcock to provide a secure, fluid tight connection. The arms on the invention are at least 2.5 cm long to provide greater ease in connection of IV lines to the connectors on the stopcock. 
     Referring to the FIG. 2, a side view of the stopcock 21 is shown with the locking connector protective assembly removed to reduce the complexity of the drawing. A port rim 44 and an input arm 25 with an arm lumen 32 are also illustrated. 
     Although FIG. 3, shows the passageways as channels on the bottom of the rotor, and extending up the outside of the rotor to the plane of the inner ends of the arms, the passageways from the rotor lumen to the arms can be radial holes from the wall of the rotor 33 to the rotor lumen 37 in other embodiments. 
     The handle 35 is at least 2 cm in length to provide greater ease in manipulation of the rotor 33 in the body 23. The operator can grasp the handle 35 and turn the rotor about an axis in the body 23 to select the desired alignment of channels with the input and output arms as indicated by pointers 43 on the rotor to direct the flow of the fluids as desired. In FIG. 2, a part of the body at the top is broken away to show a self-sealing injection port plug 41 that covers the rotor lumen 37. The outer ends of the passageways 39 are in the same rotational plane as the corresponding arms in the body, and may be aligned with the arm lumens 32 to allow fluid flow between the rotor lumen 37 through the passageway 39 to the arm lumen 32. The arm lumens 32 and passageways 39 are approximately the same cross-sectional area for decreased restriction and increased fluid flow. 
     In this embodiment, the locking connector protective assembly 101 is positioned over the female locking connector tip 29 on the input arms 25, but not the male locking connector tips 27 since the male tips are largely enclosed by their conventional design and are much less susceptible to touch contamination than female locking connector tips. Although the stopcock illustrated in FIGS. 1-3 includes three arms, this embodiment may contain from three to five arms where the input arms are in the same plane as defined by the rotation of the passageways in the rotor. Other embodiments of this invention may include input or output arms on differing planes of rotation defined by the rotation of the rotor and two or more input arms 25 with male locking connector tips 27 or female locking connector tips 29, and may have self-sealing injection port plugs 41 connected to the invention by locking connectors. 
     Referring to FIGS. 4 and 5, a top view of the locking connector protective assembly 101 and an axial view thereof are illustrated. A coil 103 consisting of a plurality of turns has a proximal (to the user) end 107 with a closure 109 thereon. The proximal end of the coil is referred to as such since this end is manipulated by the operator. The closure is comprised of a rim 113 with resilient locking tabs 117, a lid 111 that fits into the rim 113 and a flexible lid retainer link 115 that is attached to the rim and the lid. The lid 111 has a stopper 112 that fits into the end of the female locking connector tip. The lid 111 may be pushed into the female locking connector tip to plug the lumen, or flipped away from the tip and retained by the flexible lid retainer link 115. The resilient locking tabs 117 project inward from the rim 113 so that the distance T (FIG. 5) between the tips of the tabs is less than the diameter F of the outer flange of a standard female locking connector tip 129. The rim 113 and the resilient locking tabs 117 fit over the the female locking connector tip 129 and retain the locking connector protective assembly 101 on the female locking connector tip. The distal end 105 of the coil 103 has a base 119 which abuts the body of the stopcock. The inside diameter of the inner face ll9D of base ring 119 is greater than diameter F so the protective assembly can be easily pushed over the tip 129 and into position with the concave face ll9C in contact with the body 23. The coil 103 is tapered so that it is a larger diameter on the proximal portion 107 and decreases in diameter towards the distal portion 105. This taper allows the coil to flatten into one plane as it is compressed. 
     A coil is one embodiment that may be utilized to allow the closure 113 to be pushed toward the body and return to a position that allows the closure to cover the female locking connector tip. Resilient means other than a coil may be used for this purpose. A spongy means, a resilient sheet or a resilient axially slit cylinder may also be substituted for the illustrated coil in different embodiments. 
     The locking connector protective assembly 101 functions to inhibit touch contamination of the female locking connector tip 129 by the operators&#39; hands during connection of locking connectors. The locking connector protective assembly 101 may be retrofitted to prior art stopcocks or other fluid handling tubing or adaptors, by fitting the assembly over the female locking connector tip 129 where it is retained by the resilient locking tabs 117 projecting from the rim 113. The coil 103 extends over the input arm and female locking connector tip 129, and the closure 109 covers the access route to the female locking connector tip 129. When access to the female locking connector tip 129 is desired, the rim 113 is pushed in toward body 23, and lid 111 is pulled from the lumen of tip 29 and retained by the flexible lid retainer link 115. The coil 103 is compressed to allow access to the locking connector. A male locking connector tip may then be screwed onto the female locking connector tip after the removal of the cap plug 30 (if present as described in FIG. 1). The bias in the coil 103 due to its compression, is released, whereby the coil portion 103 extends the closure to a position partially encircling the male/female locking connector junction to provide a protective cover. If it is desired to disconnect the male/female connection, this may be accomplished by compression of the coil to allow access to the connectors and disconnection thereof by using a twisting motion to separate the locking connector tips followed by the insertion of a plug into the unused female locking connector tip (if desired). After the plug is inserted, the coil spring compression is released and the lid is placed onto the rim so that the locking connector protective assembly is returned to its original configuration. 
     Referring to FIGS. 6, 7 and 8, a side view of a stopcock 45 with the locking connector protective assembly 101 described in FIG. 4, and a rotor 53, is illustrated. The stopcock has a body 46 with two input arms 50 that lie in the same plane and have female locking connector tips 49, and an output arm 51 with a male locking connector tip 47. The arms have arm lumens 52 for the passage of the fluid. The stopcock 45 also has an input arm 64 (which is shown in a partial cutaway) with a back flow check valve 65. This arm is located on a plane different from the other arms and communicates with the rotor lumen by groove 67 in the rotor and running 3/4 of the circumference of the rotor in the same plane as the input ar 64 with which it is aligned and by a radial passage 69 extending radially outward from the rotor lumen to the groove. Other portions of the stopcock and locking connector protective assembly are as described above with reference to the previous drawing figures. The rotor has a handle 55 which is used to rotate the rotor in the body. A port rim 63 surrounds the self-sealing injection port plug 61 which forms the top surface and covers the lumen of a male locking connector 62 that locks onto a female locking connector 66 on top of the rotor and which provides access to the rotor lumen. 
     When a primary fluid source is connected to the input arm 64, the back flow check valve 65 is useful to avoid back flow into the input line from the other IV lines. This valve avoids back flow into the primary source by secondary input lines that may be run on pumps which exert greater pressure than the primary line. This embodiment of the invention with four arms is useful to reduce the number of conventional stopcocks normally needed in combination to provide sufficient input lines into one output line. In this embodiment, the input line with the back check valve 65 is open to the rotor lumen for 3/4 of its travel because the groove 67 runs 3/4 of the circumference of the rotor and the line is closed for 3/4 of the rotation of the rotor in the body. Groove 67 along the exterior circumference of the rotor 53 and communicating with the input arm 64 in its rotational plane during 3/4 rotational travel of the rotor is one of the methods that a particular input arm or output arm may either be selected for fluid flow or blocked off from fluid flow. The orientation of the groove 67 to the handle 55 is illustrated in FIG. 8. 
     A further embodiment of the present invention is illustrated in FIG. 9 which utilizes a countersunk injection port having a self-sealing injection port plug with a concave rubber face. This embodiment is similar to the stopcock of FIG. 6 except that the concave self-sealing injection port plug 84 covers the rotor lumen, rather than attaching to a locking connector, and has a concave shape. Also included is a body 73 and an input arm 80 (which is shown in a partial cutaway) with a back check valve 81 open to the rotor lumen for 3/4 of its travel because groove 82 in the rotor 85 runs 3/4 of the circumference of the rotor and communicates with the rotor lumen as described in FIGS. 7 and 8. In this embodiment of the invention, two input arms 75 and the output arm (not shown) are positioned in the same plane 83 of rotation of the corresponding radial holes in the rotor. The input arm 80 with a backflow check valve 81 and rotor groove 82 are in a plane of rotation different from that of the other input arms. 
     Although several embodiments of the invention are described, one skilled in art could practice alternate embodiments of the invention by varying the number of input arms on differing planes of rotation of the rotor in the body, as well as their orientation, and length of the grooves, or vary the locking connector protective assembly to provide a functional stopcock. Therefore, while the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.