The present invention pertains to a fluid communication device for mixing and transferring solutions. More particularly, it pertains to a device especially useful in high speed compounding of hyperalimentation solutions.
Hyperalimentation therapy is the intravenous feeding of, for example, a protein-carbohydrate mixture to a patient. It is used primarily to meet the patient's protein and caloric requirements which are unable to be satisfied by oral feeding. The protein may be in the form of free amino acids or protein hydrolysate and the carbohydrate commonly is dextrose. In addition to the protein and carbohydrate, vitamins (water-soluble and fat-soluble) and electrolytes also can be supplied in this therapy.
Each of these parenteral ingredients and the combination thereof are particularly susceptible to the growth of deleterious organisms and it is desirable that they be administered to the patient in a sterile condition. Thus, because these protein and carbohydrate solutions cannot be pre-compounded by the manufacturer, but must be combined at the time of their use, their compounding must be performed under sterile conditions to avoid organism growth.
A known apparatus and process for compounding hyperalimentation solutions utilizes a solution transfer system including a receiving container and a Y-transfer set. The Y-transfer set includes two separate tubes, each having an end attached to a common juncture by which solutions delivered through the tubes will pass through the juncture into the receiving container. The other end of one tube of the set is attached to the protein holding container and of the other tube of the set to the carbohydrate holding container. The desired volume of each solution being tranferred to the container is controlled by a clamp placed on each tube. The solutions may be allowed to flow into the receiving container by gravity flow. However, it has been found to be useful to transfer the solutions under the influence of a vacuum applied to the receiving container. When the receiving container is a flexible plastic container, the vacuum is created in a vacuum chamber into which the container is placed.
It has been known in the past that to ensure sterility during the compounding of hyperalimentation solutions, compounding should be performed under a laminar flow hood. Laminar flow hoods are used for reducing the risk of airborne contamination of such solutions. These units operate by taking room air and passing it through a pre-filter to remove gross contaminates, such as dust and lint. The air is then compressed and channeled through a bacterial retentive filter in the hood in a laminar flow fashion. The purified air flows out over the entire work surface of the hood in parallel lines at a uniform velocity. The bacterial retentive type of filter is designed to remove all bacteria from the air being filtered.
Compounding under a laminar flow hood aids in preventing airborne contamination, but it is relatively cumbersome and expensive and would not be useful for eliminating any other source of contamination, such as contamination caused by handling. When using a hood the operator may inadvertently perform the work at the end or outside of the hood and not within the recommended space, at least six (6) inches (0,15 m) within the hood, which insures the benefits of the air being purified. Time must be taken and care must be exercised to maintain a direct open path between the filter and the compounding area. Solution bottles and other nonsterile objects cannot be placed at the back of the hood work area next to the filter because these objects could contaminate everything downstream and disrupt the laminar flow pattern of the purified air. Also, in using a laminar flow hood, it is necessary routinely to clean the work surface of the hood before any compounding is performed.
Thus, the prior art apparatus and process discussed above are disadvantageous due to the extensive number of hand operations which are time consuming and can be error prone.
An apparatus and process utilizing a filter system in the compounding operation poses new problems. The viscosities of some of these parenteral solutions could cause filter clogging and, consequently, retard transfer through the filter and apparatus. Also, the viscosites of the solutions may be and are generally different, which could lead to an unequal or otherwise undesired mixture of them. Therefore, additional time and care must be exercised to ensure that the desired mixture of the solutions being combined is achieved.
The device of the present invention overcomes the above-discussed disadvantages and provides a unitized, sterile, quick and economical fluid path. Also, the device is arranged to provide proper orientation with respect to the compounding apparatus.
U.S. Patent No. 3 749 285 discloses a fluid communication device having a plurality of fluid lines in fluid communication, via respective pumps, with a common fluid passageway, but this prior device does not appear to afford such ease of use as devices in accordance with the present invention.
DE-A-2920975 discloses a device for infusion of dialysis solution having a fluid line including a pump tubing segment for placement under tension on a peristaltic pump.
DE-U-7736090 discloses an infusion device having a plurality of fluid lines connected between respective supply containers and a junction block and a single outlet line from the junction block.
US-A-2814404 discloses a bottle cap including a retaining ring for securing the cap to a bottle neck and a closure member connected to the retaining ring by a flexible arm, which maintains the ring and closure member in substantially the same plane in the uncovering position. The internal side faces upwardly in the uncovering position and covers the bottle opening in its closure position.
The features of the present invention are as set out in Claim 1.
In accordance with an embodiment of the present invention, a device for fluid communication is provided to be used with an apparatus for compounding a plurality of solutions, preferably under sterile conditions. The device of the present invention includes a plurality of fluid container connectors to be inserted into respective solution containers, each container containing a solution to be compounded. Fluid lines sealingly connect each container connector to a respective inlet pump fitting for providing fluid flow from the solution containers to a respecitve pump tube.
The pump tubes are elastomeric bodies fluidly connecting respective inlet pump fittings to exit pump fittings. The pump fittings include grips about their periphery to facilitate putting the pump tubes in tension about pump rollers of peristaltic pumps of the compounder. Tension of the pump tubes is maintained by placing the pump fittings in respective nets and exits provided in the housing of the compounder.
The exit pump fittings are sealingly connected to further fluid lines to provide a fluid path to a common junction block. The junction block separately receives each of the plurality of further fluid lines in a substantially parallel, vertically spaced manner so as not to inhibit fluid flow by crimping of the lines.
The common junction block provides an exit port for sealingly and sterilely receiving a further fluid connector to provide a path to a receiving container. The exit port is preferably at right angles to the entrance of the plurality of further fluid lines.
The common junction block also has a closure member associated therewith to cover the exit port and protect it from contamination when not in use. The closure member includes a retaining ring, securing the member to the block, connected to a closure by a flexible member. In the block use or uncovered position, the ring, flexible member and closure lie in a substantially common plane with the internal side of the closure facing downward to prevent collection of particulate contamination on the interior thereof. In the block non-use or covered position, the flexible member is rotated to allow the interior of the closure to cover the exit port.
One of each set of inlet and exit pump fittings are color or numerically coded to correspond to a respective pump of the compounder to provide proper orientation of the present invention with respect to the compounder. Further, the fluid lines are sized to provide the exact requirements of length for the compounder. Preferably the device is constructed to accommodate three solutions to be compounded. The device of the present invention provides a sterile, unitized, economical fluid path between solution containers containing solutions to be compounded and a receiving container.
Referring now to Figs. 1 and 2, a fluid communication device 10 of the present invention is best illustrated. Fig. 1 shows the device 10 in position for use with the high speed bulk compounder, while Fig. 2 shows the device 10 as it is removed from its sterile package. Supply containers 12, 14 and 16, shown in phantom in Fig. 1, are fluidly connected with a receiving container 18 (also shown in phantom) by device 10. The supply and receiving containers which are shown in phantom may be flexible plastic bags of the type marketed by Travenol Laboratories, Inc. of Deerfield, Illinois under the registered trademark Viaflex.
The device 10 provides a sterile fluid path from each supply container to a common junction block 20, where a receiving container can be placed in fluid communication therewith. The solutions to be compounded are transferred from the supply containers to the receiving container by peristaltic pumps 22, 24 and 26 shown in phantom). The peristaltic pumps 22, 24 and 26 effect fluid flow from the supply containers 12, 14, and 16 through the device 10 to the receiving container 18 by movement of rotatable rollers 28 of each pump which compress respective tensioned wall portions 30, 30' or 30" of the fluid path in contact therewith, forcing the fluid therein forward.
The portion 30, 30' and 30" of the fluid paths of device 10 in contact with each respective pump is an elastomeric body or pump tubing from about 100 mm (four inches) to about 150 mm (six inches) long, preferably 125 mm (five inches) long, capable of being put in tension. The ends of each pump tubing 30, 30' and 30" are connected to respective inlet and exit pump fittings 32, 32' and 32" and 34, 34' and 34" repectively, which are operatively fixed position to maintain the pump tubing in tension, such as placed within inlet and exit slots of a pump housing (not shown).
The fluid paths of device 10 start with fluid connectors 36, 36' and 36". The tips of the fluid connectors 36, 36' and 36" are adapted to be inserted into the supply containers 12, 14 and 16 respectively and prior to their use are covered with a protective sheath 38, 38' and 38" (Fig. 2) to prevent contamination of the connectors and the fluid paths. Each fluid connector is sealingly connected to a respective fluid line 40, 40' and 40", such as vinyl tubing or the like which are sealingly connected to a respective inlet pump fitting 32, 32' and 32". Further fluid lines 42, 42' and 42" are each sealingly connected to a respective exit pump fitting 34, 34' and 34" to connect it with the common junction block 20.
The inlet and exit pump fittings 32 and 34 as seen in Fig. 4 are representative of like fittings and tubings of device 10. The inlet and exit pump fittings have a ribbed portion 43 around their periphery. This ribbed portion 43 facilitates their gripping to place pump tuning 30 in tension around rollers 28. The inlet and exit pump fittings 32 and 34 are identical and have a dish shaped portion 44 at one end connected to a cylindrical portion 46 at the other end providing a shoulder portion 47. The shoulder portion 47 bears against the inlet or exit slots of the pump housing to maintain tension in the pump tubing 30 connected thereto. The pump tubing 30 is stretched over the cylindrical portion 46 of the fittings 32 and 34 to provide an interference fit therebetween. The cylindrical portion 46 includes a cylindrical fluid line receiver 48 tapered along its length therein having a shoulder portion 50. The fluid line is inserted into the cylindrical portion 46 through the dish shaped portion 44 until it contacts the shoulder 50. The line is then sealed therein. The cylindrical portion 46 then provides fluid communciation through a hollow cylindrical portion 52.
The fluid lines 40, 40' and 40" coupling respective fluid connectors 36, 36' and 36" to respective inlet pump fittings 32, 32' and 32" are preferably of the same length. The fluid lines 42, 42' and 42" coupling the exit pump fitting 34, 34' and 34" to the common junction block 20 are preferably of differing lengths to accommodate differences in the spatial relation of each pump 22, 24 and 26 to the block 20. Further, at least one of each set of inlet and exit pump fittings are either numerically, colour or otherwise coded to correspond to a respective coded operative position to provide proper orientation of the device 10.
The common junction block 20 is best seen in Fig. 3. The block 20 includes a junction body 54, a top cap 56 and a membrane 58 therebetween. The body 54 provides substantially parallel, vertically spaced tapered channels 60, 60' and 60" which are each adapted to receive a respective fluid line 42, 42' and 42" so as not inhibit fluid flow therethrough by crimping of the lines. The channels 60, 60' and 60" are tapered to provide a snug fit for fluid lines 42, 42' and 42" which are sealingly connected therein. Ports 62, 62' and 62" provided fluid communication between a respective channel and a small volume chamber 64. The chamber 64 is at substantially right angles to the channels and ports and is of an inverted truncated cone shape 66 leading into another more pronounced inverted truncated cone shape 68 leading into a cylindrical portion 70.
The top cap 56 is sealed, such as by welding to the upper portion of the body 54 and secures the membrane 58 therebetween. The top cap 56 provides a dish shaped opening 72 leading in a channel 74 which provides communication with the membrane 58. The membrane 58 has a normally closed, resiliently deformable slit 76 which extends therethrough. The slit 76 provides a sealed sterile fluid path for the entrance of a fluid connector or the like to provide a fluid path to the receiving container. This is accomplished by the membrane 58 deforming and closing about the connector. Upon withdrawal of the connector the membrane 58 will close upon itself immediately, thereby continuing to protect the fluid path of the device 10. The top cap, membrance and slit are of the type disclosed in United States Patent No. 4,197,848 which issued in the names of Scott T. Garrett, Robert R. Fasana and William L. Rudzena.
A closure or dust cover 78 is provided to protect the fluid path of device 10 when not in use. The cover 78 includes a closure member 80, a connecting member 82 and a flexible arm 84 therebetween. The connecting member 82 is ring-like and fits around the periphery of the upper end portion of the junction body 54. The top cap 56 is provided with a lip 86 at its upper end portion to prevent the member 82 from becoming dislodged from the junction body 54 and to provide a sealed connection with member 80.
The flexible arm 84 connects the connecting member 82 and the closure member 80. The arm 84 maintains the members 80 and 82 in the substantially same plane and out of the way of the functional area when not used to protect device 10, but allows easy access when needed.
The closure member 80 includes lip 88 and undercut 90 which are complemental with lip 86 of the top cap 56 to provide a sealed enclosure about the top cap 56 thereby protecting the fluid path of device 10. The member 80 is orientated with its internal side 92 facing downward, when not used to protect device 10, to prevent any particulate matter from accumulating thereon. The member 80 when sealingly covering top cap 56 requires the flexible arm 84 to be rotated or twisted about its axis to provide the proper orientation of the closure 80 with respect to the top cap 56. The member 80 also includes a pull tab 94 with a raised gripping area 96 for easy grasping of the tab 94 to facilitate the uncovering of the top cap 56.
The device 10 of the present invention hereinabove described provides a unitized, sterile, economical fluid path between a plurality of solution containers containing solutions to be transferred to a receiving container. The device is especially adapted for use with the High Speed Bulk Compounder to provide a fast, efficient, precise, sterile way of compounding solutions. Further, the device 10 provides the proper orientation of the device with respect to the compounder to prevent errors.
It is to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.