WO1988007386A1

WO1988007386A1 - Intravascular tube assembly

Info

Publication number: WO1988007386A1
Application number: PCT/US1987/000719
Authority: WO
Inventors: Mara Z. Underwood
Original assignee: Underwood Mara Z
Priority date: 1984-12-26
Filing date: 1987-03-30
Publication date: 1988-10-06

Abstract

An intravascular tube assembly is disclosed which facilitates the administration of drugs and fluids to a patient. In one embodiment the assembly comprises a plurality of tubes (5, 6) for delivering the fluids, the tubes having indicia (15, 16) disposed at intervals along their length. The indicia may be printed on the tubes at intervals of about six inches, and are printed three times at each location along the tube, around its circumference. The assembly also includes at least one generally flat separator (25) having a plurality of spaced-apart holes (42), the diameter of the holes being slightly larger than the diameter of the tubes. The separator has slots (43) which permit the tubes to be quickly snapped into place. The separator (25) therefore maintains the tubes (5, 6) in spaced relation, and prevents them from becoming tangled during the operation. The indicia on each tube are unique to that tube, enabling operating room personnel quickly to inject the proper fluid into the patient, without the need to trace the path of the tube from its fluid source.

Description

INTRAVASCULAR TUBE ASSEMBLY

BACKGROUND OF THE INVENTION

This invention relates to the field of emergency room medicine, including the care of a patient during surgery, as well as during intensive care. The invention comprises a novel assembly of intravascular tubes which facilitates the rapid and safe injection of intravascular fluids into a patient. By "intravascular" it is meant that the injections described herein may be either intravenous or intra-arterial. That is, the present invention can be used to inject fluids into both veins and arteries. For example when a patient is admitted to a hospital for emergency surgery, it is usually necessary to administer multiple intravascular fluids, including various drugs or blood. Also it may be necessary to sample the patient's blood and to measure the patient's blood pressure at different points. Because of adverse drug interactions, it is necessary to prevent the various drugs and fluids from being mixed before entering the bloodstream. Also there is usually a need to administer multiple intravenous infusions rapidly. Thus it is common to employ a plurality of separate tubes for each substance being administered to, or withdrawn from, the patient.

In an emergency room, operating room, or intensive care unit this multiplicity of tubes can be hazardous. The correct medication must be administered promptly at the correct site. But the greater the number of tubes, the greater the likelihood that the tubes will become tangled. Entanglement of the tubes, at worst, can cause fatal errors in administering drugs and fluids. At best, such entanglement slows the operation, due to the extra time required to guard against error by tracing the path of each tube, although the time required to trace the path of a tube may not seem long in absolute terms, even a short delay in administering a necessary fluid can be too long during emergency surgery. During such surgery, there is little or no time to think, especially when the life of the patient is threatened, and when so many drugs need to be given quickly and during a short period of time.

Even after the operation is concluded, it is necessary to keep the various intravascular tubes separated an organized. After a typical operation, the patient is often left with an entanglement of intravascular tubes placed on or near the chest. In order to facilitate transport of the patient following the operation, it is important that such tubes not become tangled at sites near the body. Then, after transport[to the intensive care unit or the recovery room, there begins the usually frustrating task of untangling and separating the tubes while, hopefully, not dislodging them in the process. Not only is this scenario time-consuming, but it is actually dangerous, especially if the patient requires intravenous medication immediately after transport. There are many examples of intravascular tube assemblies in the prior art. For example, U.S. Patent No. 3,316,935 shows a plurality of flexible tubes for use in administering fluids to a patient. Another example of an assembly of tubes for similar purposes is shown in U.S. Patent No. 2,954,028. U.S. Patent No. 4,308,642 gives an example of a structure for supporting an intravascular tube along side a hospital bed.

The prior art discloses the use of intravascular tube assemblies, and some, such as the first two patents cited above, disclose types of separator means for holding the tubes in spaced relation. The present invention, however, provides a safe and inexpensive means to prevent entanglement of the intravascular tubes, as well as a means for identifying the tubes rapidly and reliably when time is of the essence. This invention is particularly suited not only to situations where one needs to administer many fluids to a patient, but also to cases where one does not know, beforehand, how long the patient will need each such fluid. SUMMARY OF THE INVENTION

The present invention solves the problem described above by providing a plurality of channels of intravascular fluid, each capable of being identified by unique indicia. The indicia may be numbers, letters, bands of color, or the like, or any combination thereof. In one embodiment of the invention, the indicia may be printed along the length of each tube at constant intervals, preferably of about six inches. At each location along the length -of the tube, the indicia are repeated two or three times, around the circumference of the tube. Alternatively the indicia are printed once at each location, in a spiralling pattern along the tube, so that in one quick glance a single tube can be identified in its entirety.

The tubes are adapted, at one end, to be connected to a source of intravascular fluid, and are similarly adapted, at the other end, to be connected to a cannula or other means for injecting fluid into a patient. The indicia appearing along a given tube also appear on the collecting chamber for intravascular fluid, from which the tube receives its fluid, as well as on the plastic insert at the other end of the tube which is attached to a cannula. If the tube is to be used with other devices, besides the cannulae and fluid bags, then such other devices should be marked with indicia corresponding to the indicia of the attached tube.

In another embodiment, the indicia are preprinted on adhesive strips or tape and are affixed to identify each of the channels of intravascular fluid at various points, including optionally the fluid source (usually a bag or bottle), intermediate points along the tube, injection portals, flow adjusters, and the cannula from which the intravascular needle extends. The invention also includes at least one separator having a plurality of spaced-apart holes. In the preferred embodiment, the separator is constructed of a flat piece of plastic, and the holes are generally keyho le-shaped, so as to permit the tubes to be snapped into and out of the separator. In one embodiment of the invention, there are no indici a on the separator; thus, any gi ven tube may be inserted into any avai lab le hole in the separator. Optionally, the channels may be labelled by adhesive labels affix ed to the separator at about the time the tube is snapped in.

In another embodiment of the invention, the separator is provided with indicia which correspond to the indicia used to identify the channels of fluid. In accordance with that embodiment, only the tube providing a portion of the channel for the fluid represented by the indicium is to be inserted into the hole in the separator so identified.

In an- alternative embodiment, the separator has at -least one groove, into which the tube may be inserted, and such that the tube may be wound around the portion of the separator defining the groove. This embodiment therefore permits excess tubing to be wound up, and eliminates the confusion caused by the presence of unnecessarily long lengths of tubing.

In yet another alternative embodiment of the invention, the separator has a plurality of holes into which excess tubing can be inserted in a weaving orientation.

It is therefore an object of the invention to provide an intravascular tube assembly which facilitates the progress of emergency room procedures, surgical operations, anesthesia, and intensive care.

It is a further object of the invention to provide an assembly as described above, wherein the assembly includes means tending to prevent the entanglement of the intravascular tubes during an operation, or during the course of other care of a patient. It is a further object of the invention to provide an assembly as described above, wherein each tube of the assembly may be rapidly and reliably identified, without the need to trace the path of the tube.

It is a further object of the invention to provide an assembly as described above, wherein different groups of tubes may be held in spaced relation by different separators.

It is a further object of the invention to provide an assembly which maximizes the ability of operating room or intensive care personnel to administer as many fluids and§or medications as are necessary for the patient, and which minimizes the time required to administer such fluids.

It is a further object of the invention to provide a kit which can be used to construct an intravascular tube assembly for use in emergencies, surgical procedures, and administration of anesthesia, and in intensive care units.

It is a further object of the invention to provide a method of treating a patient in an emergency situation, which method minimizes the time spent in attending to mechanical difficulties and in the identification of numerous intravenous tubings, and which maximizes the time available for delivering a- plurality of vital fluids to the patient. Other objects and advantages of the invention will be apparent to those skilled in the art, from a reading of the following brief description of the drawings, the detailed description of the invention, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a perspective view showing a pair of tubes, constructed according to the present invention, suspended from an overhead rack.

Fig. 2 is a view taken along the line 2—2 of Fig. 1, showing a top view of one of the separators, and showing the tubes in cross-section. Fig. 3 is a cross-sectional view of one of the intravascular tubes of the present invention, taken along the line 3--3 of Fig. 1, and illustrating the indicia disposed on the tube.

Fig. 4 is a perspective view of one of the separators adapted for holding the intravascu lar tubes in spaced relation. Fig. 5 is a perspective view of an alternative embodiment of a made according to the present invention.

Figs. 6, 7, and 8 are schematic diagrams showing alternative arrangements of tubes and separators, according to the present invention. Fig. 9 is a plan view of a separator constructed according to an alternative embodiment of the invention.

Fig. 10 is a partially schematic view illustrating the use of the embodiment of Fig. 9, in the treatment of a patient.

Fig. 11 is a is a partially schematic view similar to that of Fig. 10, illustrating the use of an alternative embodiment of the invention In the treatment of a patient, in which the separators have indicia preprinted thereon and indicia are affixed to the source of intravascular fluid and cannula by adhesive means.

Fig. 12 is a perspective view, showing an alternative embodiment of the present invention in use with six different sources of intravascular fluid suspended from two overhead racks. Fig. 13 is a fragmentary perspective view showing a portion of the embodiment of the present Invention shown in Fig. 11, employing a separator having indicia displayed thereon and slots wherein tubing may be woven therethrough to take up slack.

Fig. 14 is a plan view of the separator shown in Fig. 13. Fig. 15 Is a plan view of a separator for use with the present invention, having slots and identifying indicia for six different channels of fluid.

Fig. 16 is a plan view of a separator for use with the present invention, having slots and identifying indicia for four different channels of fluid, including slots wherein tubing may be woven therethrough to take up slack.

Fig. 17 is a plan view of a label strip for use in connection with the present invention.

Fig. 18 is a cross section of the label strip of Fig. 17 taken along the line 18—18.

Fig. 19 Is a cross section of the label strip of Fig. 17 showing it in use as applied around a section of intravascular tubing.

Fig. 20 is a perspective view of a separator in accordance with the present invention, in which the channels are identified by label strips affixed thereto.

Fig. 21 is a perspective view of a roll of label tape for use in connection with the present invention.

Fig. 22 is an elevation of a dispenser for a multiplicity of rolls of label tape for use in connection with the present invention. DETAILED DESCRIPTION

The present invention comprises an assembly of intravascular tubes, which can be used to treat a patient quickly and safely during an emergency, or in an intensive care unit. The invention is especially helpful in reducing the time required to locate and administer the proper intravascular fluid. However the assembly dislosed herein may also be used in non-emergency situations, whenever a plurality of fluids must be injected and§or withdrawn - from the patient.

Fig. 1 is a perspective view of one embodiment of the invention. Intravascular tubes 7 and 9 are attached to fluid bags 5 and 6, respectively. Fluid bags 5 and 6 are suspended from overhead rack 1 which may be conveniently mounted alongside the bed of a patient (not shown). In practice, there may be two to four such racks, although usually all bottles and fluid sources are suspended from the same rack. Tubes 7 and 9 are preferably constructed of clear plastic, so that the color of the fluid flowing therethrough may be easily identified. The tubes have flow regulators 22 disposed thereon, for stopping the flow of fluid through the tubes when necessary. The number of flow regulators is not critical, and can be varied at will. The tubes are preferably identical in diameter. However, the lengths of the tubes may be different, to suit different operating room configurations. Disposed at intervals along the tubes 7 and 9 are indicia, designated generally by reference numerals 11 and 12. In the embodiment depicted in Fig. 1, the indicia comprise numbers printed on the tubes. However, the indicia can assume other forms. For example, letters, bands of color, or other symbols may be used. The indicia could even comprise simple mnemonic codes identifying certain drugs which are most commonly required during an emergency or during surgery. What is important is that the same symbol be used along the same tube, and that no tube bear indicia identical to those of any other tube. In a first embodiment, the indicia are disposed along the tube at intervals of about six inches, but other spacings are feasible. It is desirable that the intervals be reasonably short, so that each tube, if inspected at any point along its length, can be readily identified.

Fluid bags 5 and 6 are connected to tube adapters 31 and 33 respectively, and the adapters also bear indicia 15 and 16. Indicia 15 and 16 are the same as indicia 11 and 12, respectively, on the 5 attached tubes. It is important that the indicia on the adapter match the indicia on the attached tube, so that the indicia on the tube can identify the fluid flowing therethrough. The other ends of tube 7 and tube 9 are connected to cannulae -28 and 26 by cannula connectors 19 and 20. The cannula connectors 19 and 20 bear indicia

10 17 and 18, which are also the same as indicia 11 and 12, respectively, for the same reasons.

Tubes 7 and 9 are also provided with a plurality of injection portals 34, which allow the Injection of various fluids and medications at different locations along the tubes. Also,

15 additional intravascular tubes, from other sources, can be inserted into the injection portals in a "piggyback" fashion. Thus, the tubes shown in the figure can also be used to deliver supplemental fluids or medications, besides those which come from bags 5 and 6. It is understood that the tubes may be provided with an

20 assortment of components, in addition to the injection portals, such as filters, one-way valves, micro-drippers, macro-drippers, and clamps. These additional items are not shown in Fig. 1, for the sake of clarity.

Tubes 7 and 9 pass through separators 25 which are visible in

25 Fig. 1. Fig. 2 being taken along the line 2-2 of Fig. 1, provides a top view of separator 25, and includes cross-sectional views of tubes 7 and 9. Separators 25 define holes 30, which are connected with the periphery of the separators by slots 32. Separators 25 are preferably constructed of plastic. Plastic

30 construction is preferred, partly to minimize the weight of the assembly, and partly to permit the slots 32 to be opened momentarily to allow the intravascular tubes to be snapped in. The diameter of the holes is slightly larger than the diameter of the tubes, so as to allow the tubes to slide easily relative to the separator.

35 The indicia imprinted on the tubes are preferably imprinted more than once at each location along the tubes. Fig. 3, which shows tube 9 in cross-section, Illustrates indicia 12 disposed around the circumference of the tube. The indicia appear at intervals of 120 degrees. Other configurations are possible; for example it is possible to provide four sets of indicia at each location, spaced at intervals of 90 degrees, or even two sets, spaced at intervals of 5 180 degrees. It is desirable that the indicia be repeated more than twice, around the tube circumference, so that the tube may be quickly identified regardless of its orientation relative to the observer.

In still another alternative arrangement, the indicia can be 0 printed in a spiral fashion around the tubes. That is, the indicia appear only once at each location, but at each successive location, which can be about four inches away, the indicia are rotated around the tube by 90 degrees. Thus, one can identify the fluid or medication in the tube by glancing quickly at the length of tubing and by immediately observing its indicia.

As stated above the indicia appearing on each tube must also appear on the fluid bag, cannula, or any other device that is attached to the ends of the tube, However the separators 25 must not bear any indicia. Any tube may be used in any hole of any separator. It is important, in the limited time available during an emergency, that the tubes be quickly snapped into the first available hole of a separator. It is the indicia on the tube and the matching indicia on the connected input and output devices, which identify the tube. The separators serve no similar identifying function, but only act to organize spatially related tubing to prevent entanglement.

Fig. 1 shows only two intravascular tubes, for clarity of illustration. It is understood, however, that the invention may be practiced with additional tubes. Fig. 4 shows, in perspective, another separator 40, similar to separators 25, which accommodates three tubes at once. Separator 40 includes holes 42 and slots 43, and is otherwise similar in construction to separator 25 of Fig. 2.

The separator of Fig. 4 is also provided with notches 45. This is an alternative construction to that of Fig. 2, and permits the tubes to be inserted into the separator more easi ly.

In F ig. 1, there are three separators 25, each having two holes. If three or more tubes are used, and if groups of tubes need to be directed to different sites on the patient's body, then other combinations of sizes of separators may be employed. Figs. 6, 7, and 8 illustrate, in schematic form, several of such alternative 5 arrangements.

Fig. 6 illustrates one separate arrangement involving three intravascular tubes 50, 51, and 52, all passing through one separator 55. The separator 55, like all of the separators illustrated schematically in Figs. 6-8, is similar to the

10 separators shown in Figs. 2 and 4.

Fig. 7 illustrates an arrangement in which all three tubes 60, 61, and 62 pass through holes in separator 65, but wherein only tubes 60 and 61 pass through holes in separator 67.

Fig. 8 illustrates an arrangement wherein all three tubes 70,

15 71, and 72 pass through holes in separator 75. Only tubes 70 and 71 pass through holes in separator 77, and only tubes 71 and 72 pass through holes in separator 79.

Fig. 5 represents another embodiment of the separators. Separator 80 includes four holes and four slots. Holes 81

20 communicate with slots 82, and holes 84 communicate with slots 85. . Slots 82 and 85 are disposed on opposite sides of separator 80. Thus In using the separator 80, some tubes are snapped in on one side of the separator, and other tubes are snapped in on the other side.

25 Fig. 9 is a plan view of a separator constructed - according to an alternative embodiment. Separator 90 defines grooves 91, preferably disposed on both sides of the separator. The separator also has holes 92, slots 94, and notches 93, similar to those of the separator described above. The grooves 91 allow excess tubing to be

30 wrapped around the separator, and to be kept out of the way of the physician.

Fϊg. 10 illustrates the use of the separator shown in Fig.

9. Patient 98 is shown receiving infusions of fluids_, or medications from fluid containers 96 and 95 , which containers are suspended from

35 rack 97. Tubes 100 and 101 extend from containers 96 and 95, respectively, and pass through separator 99. Separator 99 is constructed in a manner similar to that of separator 90 of Fig. 9. Both tube 100 and tube 101 pass through holes (not visible in Fig. 10) of separator 99. Tube 101 is also wound around the portion of the separator defined by the groove, so that there is virtually no excess tubing hanging in the vicinity of the patient. The tubing that is so wrapped around the separator can later be unwound, if the overall length of the tubing needs to be increased.

It will be appreciated that the embodiment illustrated in Figs. 9 and 10 is a vast improvement over techniques of the prior art. In the past it has been common for nurses to wrap excess lengths of tubing around their hands, and then to tape the resulting roll of tubing in place. With the present invention the same goal can be accomplished more easily and more reliably. The embodiment described is especially useful during transport of the patient, when it is important not to have long lengths of tubing hanging down from the patient. After the patient has been moved to a recovery room, or intensive care unit, the tubing can be unwound if necessary. Clearly, other shapes for the separators are possible. The separators may be square, or even polygonal or curved. Also the number of slots and holes may be increased, as permitted by the surface areas of the separators, to accommodate additional tubes. The operation of the invention may be summarized as follows. When a patient is admitted to an emergency operating room, a plurality of fluid containers holding the substances deemed necessary by the physician in charge are connected to tubes having corresponding indicia. It is, of course, crucial that the indicia on a given tube match the indicia on the fluid container to which the tube is attached. A plurality of cannulae are inserted into various areas of the body which areas are not readily identified when looking at the plurality of tubes located near the patient's head. These cannulae are attached to the other ends of the tubes, again with attention being given to the matching of indicia on the tubes and the syringes.

When the patient needs an infusion of a given fluid or medication, the physician quickly notes the indicia on the container storing a particu lar fluid, or an injection portal on a particular IV tube. T he physician can immediately identify what type of line this is (e.g. an arterial line, or a central venous line, etc.), and to which body area it is going. This identification is important since various medications should never be given intra-arterially, while others should only be given into a central venous access line. While attempting to administer the fluid or medication, the physician may also be guided by the presence of similar indicia appearing on the lower ends of the tubes, near the areas of the body at which the fluids are ultimately being received. It is an important advantage of the invention that, after the tubes have been connected to properly labeled fluid bags and cannulae, or the like, it is no longer necessary to trace the path of the tube, regardless of how tangled the tubes have become.

One or more separators can also be snapped onto the tubes to reduce further the likelihood of entanglement and confusion of the tubes. As shown above, groups of tubes can be channeled to different areas on the patient's body by using a plurality of separators, the separators engaging different tubes, in a manner suggested by Figs. 6-8.

When additional medication is needed, T he correct tube may be identified simply by reference to its Indicia, or by reference to the matching indicia on the fluid source or the syringe. One first observes the indicia on an intravenous or ϊntra-arterial cannulae inserted into the patient, and then replaces the fluid bag with another (having the same indicia) at the other end of the tube (which also bears the same indicia). The other end of the tube is located simply and quickly by identifying its indicia. Indeed one may start at either end,(or the middle) of a given tube, and quickly locate the other end, without tracing its path.

It is noteworthy that there is no need to label the intravascular tubes after the operation is concluded, since the tubes are clearly labeled before they are used. This feature further distinguishes the present invention from the prior art, wherein it has been customary for nurses to affix labels to the tubes after the operation, when the emergency is over.

The present invention not only improves the efficiency of emergency treatment, but it also reduces the amount of post-operative effort required. Because the intravascular tubes have been properly organized from the beginning, there is no need to perform the organization task later. The invention thus provides financial savings for hospitals, both by reducing the labor required of hospital employees, and by decreasing the overall turnover time . for operating rooms. 5 The present invention may also take the form of a kit which can be used to organize the procedures of an operating room. The kit, in its preferred form, comprises at least two tubes, the tubes bearing indicia as described above, the indicia on one of the -tubes being different from the indicia on any of the other tubes, and a

10 set of separators by which the. tubes may be held in spaced-apart relation. It is possible to include, in the kit, extra tubing having the same or other indicia, but it is preferable that no two tubes, within the same kit, bear the same indicia. Thus, one reduces the risk that two tubes bearing the same indicia will accidentally

15 be used during an operation.

The kit as presented will contain an adapter for connection of one end of the tube to a fluid bag, the adapter having indicia matching the indicia on one of the tubes, and a cannula connector, also bearing unique indicia, for connecting the other end of the

20 tube to a cannula, with the adapter, tubing and connector being a single unit. Clearly, the type and number of the tubes, separators, and adapters can. be varied considerably, within the scope of the invention.

Turning now to the alternative embodiments shown in Figs. 11 to

25 22, Fig. 11 (taken with Figs. 13 and 14) illustrate schematically a setup wherein a patient 198 receives two different intravascular fluids from containers 105 and 106, respectively, supported on overhead rack 201. In accordance with the present invention, two channels of fluid are identif ied by indicia and the tubes are kept

30 separate and organized by separators through which the tubes pass. In particu lar, a separator 125 is provided with indicia 121, 124, such as the numerals "2" and "1" as illlustrated for example. As previously described, intravascular tubes 107 and 109 pass through holes 142 defined by separator 125. Tabs 115 and 116, which are 5 adhesively affixed to tube adaptors 131 and 138 of fluid containers 105, 106 respectively, bear printed indicia which correspond to the respecti ve indicia shown on the section of the separator 125 through which their respective tubes pass. Thus tab 116, which is the upper terminus of tube 109, bears the indicium "1", and separator 125 similarly bears the indicium 122 showing the same numeral "3." in section 147 at or near the hole 142 where the tube 109 passes through. Similarly tabs 117 and 119 are affixed to the termini of tubes

107 and 109 nearest the patient 198, and they too bear printed indicia corresponding to those of the respective tubes. That is, tab 118, at the lower terminus of tube 109 similar l^'ybears the indicium "1".

Correspondingly, adapter 131 of fluid container bag 105 bears the tab 115 showing the numeral "2". Adapter 131 is the upper terminus of the fluid channel defined by tube 107, which also passes through the other section 146 of separator 125. The indicium 121, which appears on section 146, is the same numeral, here "2". Similarly tab 117 at the lower terminus of tube 107 bears the numeral "2". As shown schematically in Fig. 11 and in greater detail in Fig.

13, separator 125 defines about its periphery a series of ^"notches 145 most of which communicate open directly onto one of the holes 144. Those notches 145 which do not communicate directly with holes 144 instead open onto one of the two slots 143. Each of the slots 143 terminates in a central hole 142.

In use, a tube which does not require shortening is inserted into the separator only through one of the central holes 142 by way of slot 143. As shown in Fig. 13, tube 109 passes through central hole 142 in that way. A tube that requires shortening, however, such as tube 107, is inserted into the separator through one of the central holes 142 by way of slot 145, and then a lower portion 123 of the tubing 107 is woven back through the holes 144, passing first up and then down and again and again until sufficient slack is taken up. The last passage of the tubing 107 is downward through one of the holes 144.

As shown in Figs. 13 and 14, the separator 125 is preferably divided into two visually distinct fields as shown in sections 146 and 147. These fields, shown stippled in the drawing, are preferably marked in distinctive ways, such as by contrasting colors and/or patterns. Desirably, the fields are separated by an unmarked stripe 148 for further visual clarity. Each indicium corresponds to a marking, such as a color. Thus, for example, "1" would always appear on a green field; "2" would always appear on a magenta field; etc. Alternatively, if desired, the colors or patterns themselves could constitute the indicia, and numerals could be omitted. In use, one takes care to weave a tube only through the holes 144 within a single 5 field.

In fabricating the separators such as separator 125, the fields 146, 147 and indicia 121, 124 can be printed on a sheet 126 of plastic or paper which is bonded to a plastic substrate 127. Thereafter, the various notches holes and slots 1427^~143, 144, 145 can be punched or

10 drilled out. Alternative fabrication methods such as direct printing on a plastic substrate are of course feasible.

Fig. 12 shows an operational setup with six containers of intravascular fluids, such as might be used for heart surgery or other complicated situations. For illustration, two overhead racks 201a,

15 201b each support a bottle 106a, 106b of intravascular fluid, the contents of which may be the same or different, as needed for the procedure. Rack 201a also supports bags 105a, 105b, 105c, and rack 201b supports bag 105d, each of which may contain a different intravascular fluid, as required by the procedure.

20 In accordance with the present" invention each of the containers is affixed with an adhesive tab 116a, 116b, 115a, 115b, 115c, 115d that bears an indicium (such as "1", "2", "3", "4", "5" and "6") as well as a color or other marking that visually differentiates each one from the others. The fluid channels defined by the respective tubes

25 109a, 109b, 107a, 107b, 107c, 107d are kept separate and defined by the use of such adhesive tabs and marked separators.

For example, tubes 109b and 107d define channels marked with indicia "6" and "5" respectively. The tubes pass through a separator 125c, then respectively pass thorough flow regulators 122, and

30 separators 180 and another separator 125c. Injection ports on the tubes 109b and 107d are marked with adhesive tabs 112b and llld respectively, and cannula connectors are marked with adhesive tabs 118b and 117d.

Separators 125c are marked with the indicia "5" and "6", and the

35 user must take care to insert tube 109b through the central hole 142 adjacent to the "6" and the tube 107d through the central hole 142 adjacent to the "5". This task is facilitated by the ability to mark various portions of the tubes with numbered tabs such as llld and 112b, so that it is not necessary to follow the channel back to its upper terminus to determine what it represents.

For clarity of illustration, the tubes shown passing through separators 125c are not shown woven through the holes 144 to shorten excess length, but it is to be understood that such functionality is present in the setup illustrated in this Fig. 12 as well.

Similarly, as shown, tubes 109a, 107a, 107b, 107c pass through a separator 190, flow regulators 122, a separator 180, injection ports bearing adhesive tabs 112a, Ilia, 111b, 111c, and cannula connectors bearing adhesive tabs 118a, 117a, 117b, 117c. Tubes 109a and 107a also pass through a separator 125a bearing the indicia "1" and "2". Tubes 107b and 107c similarly pass through a separator 125b bearing the indicia "3" and "4". Separator 180, which is illustrated with greater detail in Fig.

15, is a generally hexagonal shape bearing six indicia 157a, 157b, 157c, 157d, 157e, 157f, e.g., respectively the numerals from one to six. Fields of distinctive color or pattern 159a, 159b, 159c, 159d, 159 e, 159f visually distinguish the six areas of separator 180 from each other. Stripes 158 separate the respective fields. Holes 152 at the vertices of separator 180 communicate with slots 152 which are bounded by rounded notches 155. Thus, each of the six tubes shown in Fig. 12 can be individually identified and kept separate from the others by means of separators and adhesive tabs. As shown in Fig. 16, a separator 190 is provided with four fields of color 196a, 196b, 196c, 196d, and four indicia 191a, 191b, 191c, 191d respectively that conform to the color scheme used for the other separators in the set (e.g. Figs. 14 and 15). Four central holes 192 are provided in the separator 190, which communicate with peripheral notches 195 via slots 193. A set of holes 194, respectively opening onto notches 195 along the periphery are provided for weaving the tubing to take up slack in the manner described previously in connection with Fig. 13. Unmarked stripes 198 separate the fields 196 a, 196b, 196c, 196d for clarity of identification. As shown In Figs. 17 to 19, the adhesive tabs 210 that are preferably used for marking channels of intravascular fluid in accordance with the present invention comprise a strip of paper or plastic on both sides of which is printed an indicium 211 (such as "1" as illustrated) and a colored or patterned field 212 corresponding to the indicium as aforesaid. A portion 213 of the tab 210 is desirably white (or light in color) and capable of being written on, so that the ^• 5 users can mark any information they may desire to place thereon. Another portion 216 of the tab 210 is desirably provided with an adhesive layer 215 and overlaid with nonstick release paper 215 in the manner well known in the adhesive bandage art.

In use the worker peels away the release paper 215, exposing the

10 adhesive 215. As shown in Fig. 19, the tab 210 can thereupon be wrapped around a length of tubing 109; otherwise it may be affixed to any of the elements of the channel for intravascular fluid that are desirable to bear identification indicia. For example, in Fig. 20, the originally unmarked separator 240 (which corresponds to separator

15 40 shown in Fig. 4) is shown with tabs 210a, 210b, 210c affixed thereto and thereby providing indication by the indicia "1", "2" and "3" which are illustrated.

Alternatively, the adhesive tabs can be provided in roll form, as shown in Fig. 21. Roll 220 comprises a layer 213 of adhesive-coated

20 paper or plastic film and an interlayer 225 of release paper. An indicium 221 is printed on a field 222, desirably at intervals to leave an unprinted area that can be used for writing. To provide ready access to a multiplicity of roils with different indicia, a dispenser 230, as shown in Fig. 22, is used. Rolls 220a, 220b, 220c,

25 220d, 220e, 220f, 220g, 220h, each bearing a different indicium, are displayed ready for tearing off , as against a cutting edge as is well known in the art of roll tape dispensing. As illustrated, an indicium 224, numeral "1" for example, is printed on the dispenser face against a field 223 of the color or pattern printed on the tape.

30 As stated above, items for carrying out the present invention may be supplied for convenient use in the form of a kit. To carry out one or more of the embodiments of the present invention shown in Figs. 11 to 22, such a kit may, for example, comprise a set of tabs and a set of separators for use with conventional unmarked tubing sets and

35 intravascu lar infusion sources. The tabs may be similar to tab 210 shown in Fig. 17, but each set of tabs bearing one of various indicia. For example, a set of twenty-four tabs, each bearing a number from one through six on a field having a color coordinated with the indicium would be included in a kit intended to carry out the embodiment shown in Fig. 12. Similarly, a set of one or more separators 125a, 125b, 125c, 180, 190 would be included, each bearing appropriate indicia as generally shown and described above.

Alternatively, unmarked separators could be supplied with indicia-bearing tabs, for use as shown in Fig. 20. Furthermore, tabs <• may be supplied on rolls, as illustrated in Fig. 21, and rolls may be mounted in a dispenser, as shown in Fig. 22, for convenience in dispensing such tabs.

It is apparent that the objects of the invention are fulfilled by the above disclosure. It is understood, however, that many modifications may be made to the basic invention. The number and shape of the separators, the types and distribution of the indicia, and the kinds of flow regulators and auxiliary equipment can all be varied, as indicated above. The contents of a particular kit made according to the invention can be modified to suit particular surgical needs. The tubes may be provided with varying numbers of additional components, such as injection portals, clamps, and other devices. These and other such modifications are deemed to be within the spirit and scope of the following claims.

Claims

CLAIMS Having thus described the invention, what it is desired to claim and hereby protect by Letters patent is:

1. An intravascular tube assembly, comprising: a) at least two substantially clear, plastic, intravascular tubes, each of the tubes being connected at one end, to b) a tube adapter, each of said tube adapters being adapted to sealably connect to a source of fluid to be injected into a patient to one of the tubes, c) each of the tubes being connected at the other end to a cannula connector, d) each of said cannula connectors being adapted to sealably connect one of the tubes with means for injecting fluids into the patient, e) the tubes having a plurality of indicia displayed along each of said tubes, the indicia displayed along a given tube being different from the indicia displayed along any other tube of the assembly, the indicia displayed along one of said tubes being the same along the length of that tube, and f) at least one generally flat separator, the separator having a plurality of spaced-apart holes, the holes being adapted to receive said tubes, wherein the separator maintains the spacing of the tubes passing therethrough, and wherein the separator has at least one slot connecting the separator hole with the edge of the separator, whereby one of the tubes may be quickly placed within or removed from the separator hole.

2. The assembly of Claim 1, further comprising a plurality of tabs adhesively affixed to said tubes, said tabs displaying the aforesaid indicia.

3. The assembly of Claim 2, wherein the separator has a plurality of indicia displayed thereon, each indicium corresponding to the indicia displayed along the tube passing through the hole that is adjacent to the indicium on the separator. circumference of the tube.

4. The assembly of Claim 2, wherein there are at least three tubes and at least three separators, and wherein the separators comprise means for directing groups of said tubes to different locations.

5. The assembly of Claim 2, wherein the separator has a plurality of slots, all disposed along the same side of the separator.

6. The assembly of Claim 2, wherein the separator has a plurality of slots, alternate slots being disposed on opposite sides of the separator.

7. The assembly of Claim 2, wherein the separator defines a plurality of holes, each of said holes opening onto a notch in the periphery of the separator, said holes defining means for taking up slack in a tube by weaving the tube through said holes.

8. The assembly of Claim 2, wherein the separator includes slots communicating with the holes, the slots having notched ends.

9. The assembly of Claim 2, wherein the tubes include at least one injection portal for injecting fluid into the tubes.

10. An intravascular tube assembly comprising: a) a support means, b) at least two channels of intravascular fluid, each of said channels comprising: i) means for storing fluids, the storage means being suspended from the support means, and the storage means being connected to ii) adapter means for connecting a tube to the storage means, iii) a substantially clear, plastic intravascular tube, being connected at one end to the adapter means of the storage means, iv) cannula connector means, attached to the other end of the tube, c) at least two separators, the separators comprising generally flat members having spaced-apart holes through which the tubes are received, the holes being adapted to receive said tubes, wherein the separator maintains the spacing of the tubes passing therethrough, and wherein the separator has at least one slot connecting the separator hole with the edge of the separator, whereby one of the tubes may be quickly placed within or removed from the separator hole, and d) means for displaying indicia along each channel of fluid, all of the indicia being displayed along each channel matching each other.

11. The assembly of Claim 10, wherein at least one of the indicia is on a tab that is adhesively affixed to the channel of intravascular fluid to which its indicium corresponds.

12. The assembly of Claim 10, wherein at least one of the indicia is on one of the separators.

13. The assembly of Claim 12, wherein the tubes further comprise flow regulator means for restricting - the flow of fluids through the tubes.

14. The assembly of Claim 12, wherein the periphery of one of the separators defines a plurality of holes, each of said holes opening onto a notch in the periphery of the separator, said holes defining means for taking up slack in a tube by weaving the tube through said holes.

15. The assembly of Claim 14, wherein the separators include slots communicating with the holes, the slots having notched ends.

16. The assembly of Claim 15, wherein the tubes include at least one injection portal for injecting fluid into the tubes.

17. An intravascular tube identification and separator kit, comprising: a) at least two adhesive-backed tabs having different indicia displayed thereon, and b) at least two generally flat separators, the separators having spaced-apart holes adapted to receive the tubes through the holes, wherein the separator maintains the spacing of the tubes passing therethrough, and wherein the separator has at least one slot connecting a separator hole with the edge of the separator, whereby one of the tubes may be quickly placed within or removed from the separator hole, the separators having indicia displayed thereon that correspond to indicia displayed on said tabs, each of said indicia displayed on said separator being associated with one of said separator holes.

18. The kit of Claim 17, wherein each of the tabs has printed thereon an alphanumerical indicium and a color that is associated with said indicium.

19. The kit of Claim 17, wherein the periphery of one of the separators defines a plurality of holes, each of said holes opening onto a notch in the periphery of the separator, said holes defining means for taking up slack in a tube by weaving the tube through said holes.

20. A method of treating a patient in an emergency context, comprising the steps of: a) attaching a plurality of sources of therapeutic fluid to a first end of each of a plurality of tubes, b) providing indicia on each of said sources of fluid and on each of said tubes, the indicia on each of the said tubes being different from the indicia on the others of the said tubes, c) identifying the other end with one of said tubes according to the indicia appearing at the other first ends, d) affixing a cannula to the other end of the identified tube, and e) injecting one of said therapeutic fluid into the patient, f) while maintaining the tubes in spaced relation and in an untangled condition through the use of separators.

21. The method of Claim 20, further comprising the steps of providing additional fluid for administration to the patient, identifying the correct intravascular tube by observing the indicia on the tubes, and attaching the additional fluid or medication to the correct tube.

22. The method of Claim 20, further comprising the step of taking up slack in a tube by weaving the tube through holes provided therefor in one of the separators.

23. An intravascular tube assembly, comprising: a) at least two substantially clear, plastic, intravascular tubes, each of the tubes being connected at one end, to b) a tube adapter, each of said tube adapters being adapted to sealably connect to a source of fluid to be injected into a patient to one of the tubes, c) each of the tubes being connected at the other end to a cannula connector, d) each of said cannula connectors being adapted to sealably connect one of the tubes with means for injecting fluids into the patient, e) the tubes having a plurality of indicia displayed along each of said tubes at predetermined intervals, the indicia appearing on a given tube being different from the indicia appearing on any other tube of the assembly, the indicia appearing on one of said tubes being the same along the length of that tube, and f) at least one generally flat separator, the separator having a plurality of spaced-apart holes, the holes being adapted to receive said tubes, wherein the separator maintains the spacing of the tubes passing therethrough, and wherein the separator has at least one slot connecting the separator hole with the edge of the separator, whereby one of the tubes may be quickly placed within or removed from the separator hole.

24. The assembly of Claim 23, wherein the indicia are displayed at least twice at each location along the tube, around the circumference of the tube.

25. The assembly of Claim 23, wherein the indicia are displayed three times at each location along the tube, around the circumference of the tube.

26. The assembly of Claim 24, wherein there are at least three tubes and at least three separators, and wherein the separators comprise means for directing groups of said tubes to different locations.

27. The assembly of Claim 24, wherein the separator has a plurality of slots, all disposed along the same side of the separator.

28. The assembly of Claim 24, wherein the separator has a plurality of slots, alternate slots being disposed on opposite sides of the separator.

29. The assembly of Claim 24, wherein the separator defines at least one groove, the groove being sufficiently wide to permit the wrapping of a length of tubing around the portion of the separator defining the groove.

30. An intravascular tube assembly comprising: a) a support means, b) at least two means for storing fluids, the storage means being suspended from the support means, each of the storage means being connected to indicia-bearing adapter means for connecting a tube to the storage means, c) at least two substantially clear, plastic intravascular. tubes, each tube being connected at one end to the respective adapter means of the respective storage means, each tube having a plurality of indicia disposed at substantially constant intervals along the length of the tube, the indicia displayed on any one of the tubes being different from the indicia on any of the other tubes, d) indicia-bearing cannula connector means, attached to the other ends of the tubes, and e) at least two separators, the separators comprising generally flat members having spaced -apart holes through which the tubes are received, the holes being adapted to receive said tubes, wherein the separator maintains the spacing of the tubes passing therethrough, and wherein the separator has at least one slot connecting the separator hole with the edge of the separator, whereby one of the tubes may be quickly placed within or removed from the separator hole, f) wherein the indicia on each tube match the indicia on the adapter means and the cannula connector means to which the tube is connected.

31. The assembly of Claim 30, wherein the indicia on the tubes are displayed at intervals of about six inches along the tubes.

32. The assembly of Claim 31, wherein the indicia are displayed three times, at each location along the tube, around the circumference of the. tube.

33. The assembly of Claim 32, wherein the tubes further comprise flow regulator means for restricting the flow of fluids through the tubes.

34. The assembly of Claim 33, wherein the separators have at least one groove, the groove being sufficiently wide to accommodate at least one of the tubes, wherein the tubes may be wrapped around the portion of the separator defining the groove.

35. The assembly of Claim 33, wherein the separators include slots communicating with the holes, the slots having notched ends.

36. The assembly of Claim 33, wherein the tubes include at least one injection portal for injecting fluid into the tubes.

37. An intravascular tube assembly kit, comprising: a) at least two substantially clear, plastic intravascular tubes, the tubes bearing a plurality of indicia, the indicia being disposed at substantially constant intervals along the length of the tube, b) at least two generally flat separators, the separators having spaced-apart holes adapted to receive the tubes through the holes, wherein the separator maintains the spacing of the tubes passing therethrough, and wherein the separator has at least one slot connecting the separator hole with the edge of the separator, whereby one of the tubes may be quickly placed within or removed from the separator hole, c) adapter means for connecting one end of each of the tubes to different sources of fluid, the adapter means having indicia matching the indicia on the tubes, and d) cannula connector means for connecting the other end of each of the tubes to a cannula, the cannula connector means having indicia matching the indicia on the tubes.

38. The kit of Claim 37, further comprising at least one cannula, adapted for connection to at least one of the tubes.

39. A method of treating a patient in an emergency context, comprising the steps of: a) attaching a plurality of sources of therapeutic fluid to a first end of each of a plurality of tubes, each of said tubes having indicia disposed along the length of the tubes, the indicia on each of the said tubes being different from the indicia on the others of the said tubes, b) identifying the other end with one of said tubes according to the indicia appearing at the other first ends, c) affixing a cannula to the other end of the identified tube, and d) injecting one of said therapeutic fluid into the patient, e) while maintaining the tubes in spaced relation and in an untangled condition through the use of separators.

40. The method of Claim 39, further comprising the steps of providing additional fluid for administration to the patient, identifying the correct intravascular tube by observing the indicia on the tubes, and attaching the additional fluid or medication to the correct tube.

41. The assembly of Claim 24, wherein the separator includes slots communicating with the holes, the slots having notched ends.

42. The assembly of Claim 24, wherein the tubes Include at least one Injection portal for injecting fluid into the tubes.

43. The method of Claim 31, further comprising the step of wrapping excess lengths of tubing around the separator.