Abstract:
In an IV administration set including an IV solution container, a drip chamber having a hollow spike for introduction into the container, and an IV line having a port for delivering the IV solution to a patient, a system for identifying the components of the set includes a first identification element removably attached to the drip chamber for subsequent attachment to the container; a second identification element affixed to the drip chamber; and a third identification element either permanently or removably attached to the port. The first identification element is adhesively attached to the drip chamber to allow its removal for subsequent attachment to the container. The second identification element is permanently affixed to the drip chamber. The third identification element is integral with or removably attached to the IV line port. The first, second, and third identification elements bear matching identification symbols.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is a Continuation-in-Part of co-pending application Ser. No. 10/629,222; filed Jul. 29, 2003; which is a Continuation-in-Part of application Ser. No. 09/971,179, filed Oct. 4, 2001, now U.S. Pat. No. 6,613,012; which is a Continuation-in-Part of application Ser. No. 09/854,711, filed May 14, 2001, now abandoned. The disclosures of these prior applications are incorporated herein by reference. 
     
    
     
         [0002]    This application claims the benefit of Invention Disclosure Documents Nos. 481,332, filed Oct. 16, 1999; and 498,899, filed Aug. 22, 2001.  
         FEDERALLY-SPONSORED RESEARCH OR DEVELOPMENT  
         [0003]    Not Applicable  
         BACKGROUND OF THE INVENTION  
         [0004]    The present invention relates to a system for uniquely identifying each one of two or more intravenous (IV) lines that may be simultaneously employed to deliver drugs intravenously to one or more patients respectively from two or more containers (such as IV bags or bottles).  
           [0005]    There are medical situations, such as emergency rooms, trauma centers, and wards, in which two or more patients are simultaneously receiving IV drugs. Also, a single hospital patient often requires the administration of multiple IV drugs delivered separately, but simultaneously, through two or more separate IV sets, at widely different dosage rates. In such situations, it is necessary to assure that each container of drug solution is properly matched to the correct IV line and from there to the correct patient. Confusion in matching these elements must be avoided to assure that each drug is administered in the proper dosage to the proper patient, lest a patient be injured through the administration of the wrong drug or an improper dose of the correct drug. Additionally, there have been numerous instances of contraindicated medications being introduced into an IV line at a “Y-site” or an in-line port, with possible endangerment of the patient. To date, efforts to avoid such confusion have largely been ad hoc. For example, medical personnel may attach numbered pieces of adhesive tape to IV containers and to IV lines to match them up properly. Still, a more reliable mechanism has been sought to achieve these ends.  
         SUMMARY OF THE INVENTION  
         [0006]    Broadly, the present invention is a system for identifying IV administration set components, wherein the IV set includes an IV solution container, a drip chamber having a hollow spike for introduction into the container, and an IV line for delivering the IV solution to a patient, wherein the system comprises a first identification element that is removably attached to the drip chamber for subsequent attachment to the container; a second identification element permanently affixed to the drip chamber; and a third identification element attached to a Y-site or port in the IV line.  
           [0007]    In specific preferred embodiments, the first identification element is a strip or patch that is adhesively attached to the drip chamber in a manner that will allow it to be removed therefrom for subsequent attachment to the IV solution container. The second identification element is a marker, preferably a strip or a patch, that is permanently affixed to the drip chamber. The third identification element is attached to a Y-site or port that is part of the IV line. The third identification element may be an integral part of the Y-site or port, or it may be removably attached to it. The first, second, and third identification elements bear matching identification symbols. In the context of this invention, the term “symbol” is deemed to encompass one or more letters, numbers, geometric shapes, abstract shapes, colors, and any combination of these elements. The term “symbol” may also include a color alone.  
           [0008]    Viewed another way, the system of the invention comprises a matched set of plural identification elements bearing matching identification symbols, wherein a first one of the set is attachable to the IV container; a second one of the set is attached to the drip chamber; and a third one of the set is attached to the IV line remote from the first and second identification elements in the set. In practice, the system will advantageously include two or more such matched sets of identification elements, each set bearing a unique identification symbol. In the context of this invention, however, the term “system” is meant to encompass one or more such matched sets of identification elements. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]    [0009]FIG. 1 is an elevation view of an IV administration set identification system in accordance with a first embodiment of the present invention, showing the system in use on a typical IV administration set;  
         [0010]    [0010]FIG. 2 is an elevational view of the first identification element of the IV set identification system used on the IV administration set of FIG. 1;  
         [0011]    [0011]FIG. 3 is an elevational view of the second identification element of the IV set identification system shown in FIG. 1;  
         [0012]    [0012]FIG. 4 is an elevational view of the third identification element of the IV set identification system shown in FIG. 1;  
         [0013]    [0013]FIGS. 5, 6,  7 , and  8  are elevational views of identification elements showing alternative types of identification symbols;  
         [0014]    [0014]FIG. 9 is a side elevational view of a third identification element that is removably attached to a Y-site or port, in accordance with a second embodiment of the invention;  
         [0015]    [0015]FIG. 10 is a front elevational view of the third identification element of FIG. 9 and the Y-site or port to which it is removably attached, taken along line  10 - 10  of FIG. 9;  
         [0016]    [0016]FIG. 11 is a bottom plan view of the third identification element of FIG. 9 and the Y-site or port to which it is removably attached, taken along line  11 - 11  of FIG. 10;  
         [0017]    [0017]FIG. 12 is a perspective view of another form of the third identification element in accordance with the second embodiment of the invention, showing it in an open position;  
         [0018]    [0018]FIG. 13 is a perspective view of the third identification element of FIG. 12, showing it in a closed position;  
         [0019]    [0019]FIG. 14 is an elevational view of a prior art Luer-type Y-site or port;  
         [0020]    [0020]FIG. 15 is an exploded elevational view of an improved Luer-type Y-site or port having an attached identification element, in accordance with a third embodiment of the invention;  
         [0021]    [0021]FIG. 16 is an elevational view of the Y-site or port of FIG. 15, showing the assembled Y-site or port; and  
         [0022]    [0022]FIG. 17 is an elevational view of an improved Luer-type Y-site or port having an attached identification element, in accordance with a modification of the third embodiment of the invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    Referring first to FIG. 1, a typical IV administration set  10  is shown, comprising a flexible plastic bag  12  serving as a container or reservoir for an IV drug solution (not shown). The set  10  also includes a drip chamber  14  having a hollow needle or spike  16  adapted to puncture the bag  12 . The drip chamber  14  has an outlet  18  that communicates with a first segment  20  of a flexible IV line. The first IV line segment  20  has an outlet end that communicates with a first inlet branch  22  of a Y-shaped port or “Y-site”  24 . The Y-site  24  is modified in accordance with the present invention, as will be described below. The Y-site  24  may advantageously have a second inlet branch  26  sealed by a puncturable septum  28 . The septum  28  may be punctured by the needle of a syringe (not shown), or opened by a Luer connector or other device (not shown), for the administration of a supplemental drug into the IV line through the second inlet branch  26 , as is well known in the art. The Y-site  24  has an outlet branch  30  that communicates with a second segment  32  of the flexible IV line, which terminates in an IV needle (not shown) that is adapted for insertion into a vein of a patient (not shown). Preferably, the outlet branch  30  is aligned axially with the second inlet branch  26 , so as to form therewith a continuous tubular body.  
         [0024]    A first embodiment of the identification system of the present invention is shown in FIGS. 1, 2,  3 , and  4 . The system comprises a first identification element, in the form of a first adhesive patch or strip  38  (FIG. 2); a second identification element, preferably in the form of a second adhesive strip or patch  40  (FIG. 3); and third identification element, in the form of a flattened extension  42  that extends laterally or outwardly from the tubular body that comprises the second inlet branch  26  and the outlet branch  30  of the Y-site  24 , and that is advantageously formed integrally therewith (FIG. 4).  
         [0025]    The first adhesive strip or patch  38  (FIG. 2) includes a pull tab  48  at one end and an adhesive backing  50  on its reverse side, but not on the back of the pull tab  48 . The first adhesive strip or patch  38  is initially adhesively attached to the drip chamber  14  (as shown in FIG. 2 and in solid outline in FIG. 1). When the identification system of the present invention is used, however, the first adhesive strip or patch  38  is removed from the drip chamber  14  by means of the pull tab  48 , and it is then adhesively applied to the exterior of the IV container  12 , as shown in broken outline in FIG. 1.  
         [0026]    The second adhesive strip or patch  40  also has an adhesive backing  44  (FIG. 3) that allows it to be fixed to the drip chamber  14  (as shown in FIG. 1). The adhesive backing  44  is advantageously such as to fix the second strip or patch  40  permanently to the drip chamber  14  as a permanent marker. Alternatively, the second identification element may simply be an identification symbol permanently marked on the drip chamber.  
         [0027]    The first adhesive strip or patch  38 , the second adhesive strip or patch  40 , and the coupler extension  42  are each marked with a matching identification symbol  46 . As shown in FIGS. 1, 2,  3 , and  4 , the symbol  46  may be a numeral. Preferably, color may be used as part of the identification symbols  46 , whereby the symbols  46  have a matching color as well as a matching number. Still more preferably, the Y-site  24  may be made in the same color as the symbols  46 .  
         [0028]    In use, the identification system of the present invention will usually comprise two or more sets of identification elements, each set comprising a first strip or patch  38 , a second strip or patch  40 , and a Y-site  24  with an extension  42  bearing the same identification symbol  46 , unique to that set.  
         [0029]    [0029]FIGS. 5, 6, and  7  show alternative forms of the identification system, using different types of identification symbols. In FIG. 5 the symbol  46 ′ is a letter, preferably in combination with a matching color. In FIG. 6 the symbol  46 ″ is a color alone, the matching color being the predominant (if not sole) color of both the tab  42  and the strip  40 . In FIG. 7 the symbol  46 ′″ is a colored geometric shape. Still other types of symbols may be Roman numerals, abstract shapes and designs, and letters of non-Latin alphabets.  
         [0030]    [0030]FIG. 8 illustrates an alternative form of the third identification element. In this form, the coupler or Y-site  52  is structurally an ordinary device of this type, lacking the extension  42  described above. The Y-site  52  is marked with an identification symbol  54  by means of a band  56  attached around the inlet branch of the coupler  52 , the band  56  bearing the symbol  54 . The band  56 , which thus constitutes the third identification element, is preferably applied as a segment of shrink tubing, but it may also be in the form of an adhesive strip.  
         [0031]    In use, the practitioner is provided with a drip chamber  14  to which the first identification element  38  is removably attached and the second identification element  40  is permanently fixed, and an IV line  20  having a Y-site or port  24  that includes the third identification element in the form of the integral extension  42  or the band  56 . When an IV solution container  12  is selected, the drip chamber  14  is connected to the IV solution container  12  (by means of the hollow spike  16 ). The first identification element  38  is then removed from the drip chamber  14  and attached to the IV solution container  12 . In this manner, a high degree of certainty is provided that the IV solution container is matched to the proper IV line.  
         [0032]    [0032]FIGS. 9, 10, and  11  illustrate another embodiment of the invention, in which the third identification element is in the form of an attachment  60  that is removably attachable to a standard Y-site  62  having a first inlet branch  63   a  and a second inlet branch  63   b . The attachment  60  comprises a sleeve  64  with an axial slit  66  and an integral lateral extension  68  that is marked with an identification symbol  70 . The integral extension  68  is preferably located diametrically opposite the axial slit  66 , and it is oriented substantially parallel to the slit  66 . The sleeve  64  is made of a resilient, flexible, plastic material, and it is shaped and dimensioned to fit over and to conform to the exterior surface of the Y-site  62 . The sleeve  64  can thus be slightly spread apart along the axial slit  66  to allow the second IV line  32  downstream from the Y-site  62  to be passed through the slit  66 , and then the attachment  60  is pushed upwardly from the lower (downstream) end of the Y-site  62  until the Y-site  62  is received in the sleeve  64 . The sleeve  64  is widened at its upper (upstream) end to accommodate the first inlet branch  63   a  of the Y-site  62 . Likewise, the slit  66  is widened at its upper (upstream) end to accommodate the second inlet branch  63   b  of the Y-site  62 . The attachment  60  may be removed by just reversing the aforementioned installation process. Alternatively, the attachment  60  can be installed snapping the sleeve  64  directly onto the Y-site  62  by spreading the sleeve  64  apart along the slit  66 . Likewise, the sleeve  64  can be spread apart along the slit  66  for removal from the port or Y-site  62 .  
         [0033]    [0033]FIGS. 12 and 13 illustrate another form of a snap-on attachment  80  that functions as the third identification element in the second embodiment of the invention. The attachment  80  comprises first and second mating sections  82   a ,  82   b , respectively, joined by an integral hinge  84 . Each of the sections comprises a trough-like portion  86 , semicircular in cross-section, adjacent to, and aligned along, the hinge  84 ; and a flat, tabular portion  88  extending outwardly from the trough-like portion  86 . Each of the trough-like portions  86  has a substantially semicircular cut-out  90  in the side adjoining the hinge  84 . The tabular portion  88  of the first section  82   a  includes an aperture  92 , while the tabular portion  88  of the second section  82   b  includes a post or peg  94  that is configured and dimensioned to snap into the aperture  92  with a friction fit.  
         [0034]    As shown in FIG. 13, the first and second sections  82   a ,  82   b  are foldable toward each other along the hinge  84 , so that the tabular sections  88  fold flat against each other, with the snap-together engagement between the peg  94  and its mating aperture  92  holding the two sections together. In this closed or folded configuration, the trough-like portions  86  together form a tubular sleeve  96  that is shaped and dimensioned to fit over and to conform to the exterior surface of the standard Y-site  62 , of the type described above with reference to FIGS. 8, 10, and  11 . Also, with the attachment  80  in its folded position, the cut-outs  90  form a substantially circular hole  98  that is dimensioned to receive the second inlet branch  63   b  of the Y-site or port  62 , while the tabular portions  88  form an extension  100 , on the outer surface of which a symbol  102  may be provided. Thus, the attachment  80  is placed over the Y-site or port  62 , so that the second inlet branch  63   b  extends through the cut-outs  90 , and the sections  82   a ,  82   b  are folded together along the hinge  84 , and snapped together using the peg  94  and the mating aperture  92 , whereby the attachment  80  is secured to the Y-site or port  62  with the second inlet branch  63   b  extending through the hole  98  formed by the cut-outs  90 .  
         [0035]    The method of using the second embodiment of the invention is the same as that described above for the first embodiment, except that the practitioner is provided with an IV line having a standard Y-site or port  62  and an appropriate snap-on attachment  60  or  80  for attachment to the Y-site or port  62 . When an IV solution container  12  is selected, the drip chamber  14  is connected to it, and the first identification element is removed from the drip chamber and applied to the solution container. The third identification element (the attachment  60  or the attachment  80 ) is then attached to the Y-site or port  62  (as described above), the attachment  60  or  80  having an identification symbol  70  or  102  that matches the identification symbol on the first and second identification elements.  
         [0036]    [0036]FIG. 14 shows a prior art Luer-type Y-site or port  100 , having a first inlet branch  102 , and a second inlet branch  104  formed as a threaded Luer fitting  104 . The Y-site or port  100  may typically have an internal valve (not shown) that is opened when a conduit having an appropriately configured and mating Luer fitting (not shown) is connected to the integral Luer fitting  104 .  
         [0037]    [0037]FIGS. 15 and 16 show a Y-site or port  110 , of the type described above with reference to FIG. 14, that has been modified, in accordance with a third embodiment of the invention, to include a permanently-attached connector member  112  having an integral identification element  114 , formed as a flattened lateral extension, as described above in connection with the first embodiment. The Y-site or port  110  has a tubular main body  115  containing a valve (not shown), as described above; a first inlet branch  116 ; a second inlet branch  118 ; and an outlet branch  119 . The second inlet branch  118  is configured as a hollow, tubular, substantially cylindrical member, preferably formed with a peripheral lip  120  around its open proximal end. The main body  115  advantageously has a peripheral rim  121  at its proximal end, at its juncture with the second inlet branch  118 .  
         [0038]    The connector member  112  comprises a tubular sleeve  122  having an inside diameter dimensioned to fit coaxially around the second inlet branch  118  and the rim  121  at the proximal end of the main body  115 . Extending proximally from the sleeve  122  is a threaded Luer fitting  124 . The sleeve  122  advantageously has a distally-extending portion  126 , diametrically opposed to the first inlet branch  116 , to which the identification element  114  is attached.  
         [0039]    The connector member  112 , comprising the sleeve  122 , the Luer fitting  124 , and the identification element  114  (which bears an identification symbol  128 ), is preferably formed as an integral unit. The connector member  112  is permanently fixed to the body  115  and or the second inlet branch  118  of the Y-site or port  110  by a suitable adhesive, or by other means, such as, for example, ultrasonic welding, to form an improved Luer-type Y-site or port  130  with an integral identification element  114 , as shown in FIG. 16.  
         [0040]    [0040]FIG. 17 shows a Luer-type Y-site or port  140  in accordance with a modification or variation of the above-described embodiment of FIGS. 15 and 16. In accordance with this variation, the Y-site or port  140  is formed as an integral unit (e.g., by molding), comprising a hollow, tubular main portion or body  142 , a first inlet branch  144 , a second inlet branch  146 , an outlet branch  148 , and an identification element  150 , with an identification symbol  152 . The identification element is formed as a flattened extension that is integral with the body  142  and that extends laterally from it. The second inlet branch  146  is configured as a threaded Luer fitting. As in the devices described above with reference to FIGS. 14, 15, and  16 , the body  142  may advantageously contain a valve that is opened by a mating Luer fitting.  
         [0041]    While preferred embodiments of the invention have been described herein, it will be appreciated that a number of variations and modifications will suggest themselves to those skilled in the pertinent arts. These variations and modifications are considered within the spirit and scope of the invention, as defined in the claims that follow.