EP0112356B1 - Dispositif de communication de fluide - Google Patents

Dispositif de communication de fluide Download PDF

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Publication number
EP0112356B1
EP0112356B1 EP83902012A EP83902012A EP0112356B1 EP 0112356 B1 EP0112356 B1 EP 0112356B1 EP 83902012 A EP83902012 A EP 83902012A EP 83902012 A EP83902012 A EP 83902012A EP 0112356 B1 EP0112356 B1 EP 0112356B1
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EP
European Patent Office
Prior art keywords
fluid
pump
exit port
fittings
junction block
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
EP83902012A
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German (de)
English (en)
Other versions
EP0112356B2 (fr
EP0112356A1 (fr
EP0112356A4 (fr
Inventor
Lawrence R. Hogan
Herbert Mittleman
Edward G. Oilschlager
Ellen Rouch
William L. Rudzena
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter Travenol Laboratories Inc
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Application filed by Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Publication of EP0112356A1 publication Critical patent/EP0112356A1/fr
Publication of EP0112356A4 publication Critical patent/EP0112356A4/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions

Definitions

  • 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.
  • vitamins water-soluble and fat-soluble
  • 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.
  • 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.
  • the receiving container is a flexible plastic container, the vacuum is created in a vacuum chamber into which the container is placed.
  • 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.
  • 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.
  • 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 inlets 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.
  • 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.
  • the fluid lines are sized to provide the exact requirements of length for the compounder.
  • 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.
  • 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 effecffluid 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 four inches to about six inches long, preferably 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" repec- tively, 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 tubing 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nutrition Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
  • Executing Machine-Instructions (AREA)
  • Saccharide Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

Dispositif stérile, uni et économique réalisant un chemin de fluide entre une pluralité de solutions (12, 14, 16) à mélanger et un récipient récepteur (18). Le dispositif comprend une pluralité de connecteurs de fluide et de conduites de fluide reliées de manière étanche aux ajustages respectifs de pompe, ce qui permet d'obtenir des chemins individuels jusqu'à un bloc commun de raccordement (20). Le bloc commun de raccordement (20) comprend une partie (60) recevant les conduites de fluide et les empêchant de friser de manière à maintenir l'écoulement du fluide. Le bloc (20) comprend également un orifice de sortie (76) réalisant un raccordement stérile étanche avec le récipient récepteur (18). Une fermeture (78) est également prévue pour protéger l'orifice de sortie (76) de toute contamination lorsque l'orifice (76) n'est pas en communication fluide avec le récipient récepteur (18).

Claims (12)

1. Dispositif de communication de fluide comprenant une pluralité de conduites de fluide en communication de fluide, par l'intermédiaire de pompes péristaltiques respectives, avec un passage de fluide commun, le dispositif comprenant une pluralité de premières conduites de fluide (40, 40', 40"), chaque dite première conduite de fluide reliant un connecteur de fluide respectif (36, 36', 36") à un premier raccord de pompe respectif (32, 32', 32") pour constituer entre eux un chemin de fluide, le dispositif étant caractérisé par
une pluralité de segments de tube de pompe (30, 30', 30") maintenus en tension et reliant chacun desdits premiers raccord de pompe à un deuxième raccord de pompe respectif (34, 34', 34") pour constituer entre eux un chemin de fluide;
une pluralité de deuxièmes conduites de fluide (42, 42', 42"), chaque deuxième conduite de fluide reliant un deuxième raccord de pompe respectif à un bloc de jonction commun (20) qui comporte un passage de fluide (66), en communication de fluide avec chacune des deuxièmes conduites de fluide (42, 42', 42"), et un orifice de sortie (74) en communication avec ledit passage de fluide (66) de manière à fournir un chemin pour une nouvelle communication de fluide à l'extérieur du bloc de jonction.
2. Dispositif suivant la revendication 1, dans lequel un organe obturateur (78) est prévu pour couvrir ledit orifice de sortie (74) de manière à empêcher l'accumulation de matière en particules sur celui-ci.
3. Dispositif suivant la revendication 2, dans lequel ledit organe obturateur (78) comprend un élément de fermeture (80) et un anneau de retenue (82) qui fixe ledit élément de fermeture audit bloc de jonction commun (20).
4. Dispositif suivant la revendication 3, dans lequel ledit organe obturateur (78) comprend en outre un élément tournant flexible (84) reliant ledit anneau de retenue (82) audit élément de fermeture (80), et lesdits élément de fermeture, élément flexible et anneau de retenue sont placés sensiblement dans le même plan lorsque ledit orifice de sortie (74) est découvert.
5. Dispositif suivant la revendication 4, dans lequel la partie (88, 90, 92) de l'élément de fermeture qui s'engage sur l'orifice de sortie est tournée vers le bas lorsqu'elle ne recouvre pas ledit orifice de sortie, de manière à éviter la collecte de toute contamination en particules sur ladite partie.
6. Dispositif suivant la revendication 5, dans lequel les premiers raccords de pompe (32, 32', 32") et les deuxièmes raccords de pompe (34, 34', 34") comportent des éléments de préhension, autour de leur périphérie, prévus pour faciliter la mise en tension des segments de tube de pompe (30, 30', 30"), et au moins l'un des premiers et deuxièmes raccords de pompe est codé pour indiquer l'orientation correcte par rapport à une position de fonctionnement codée respective pour une utilisation correcte.
7. Dispositif suivant l'une quelconque des revendications précédentes, dans lequel les segments de tube de pompe (30, 30', 30") sont raccordés de façon étanche aux raccords de pompe (32, 32', 32", 34, 34', 34") par un joint à ajustement serré entre les tubes et les raccords.
8. Dispositif suivant l'une quelconque des revendications précédentes, dans lequel chacun desdits segments de tube de pompe (30, 30', 30") est un corps en élastomère qui peut être placé en tension autor de galets associés d'une pompe péristaltique respective, afin d'engendrer un écoulement de fluide dans ledit tube.
9. Dispositif suivant l'une quelconque des revendications précédentes, dans lequel la longueur de chacun desdits segments de tube de pompe (30, 30', 30") est de 10 cm (4 inches) à 15 cm (6 inches) et de préférence de 12,5 cm (5 inches) environ.
10. Dispositif suivant l'une quelconque des revendications précédentes dans lequel ledit passage de fluide (66) comporte des orifices espacés sensiblement parallèles (60, 60', 60") pour recevoir lesdites deuxièmes conduites de fluide et maintenir lesdites deuxièmes conduites de fluide (42, 42', 42") en relation espacée et sensiblement parallèle, de manière à éviter un pliage.
11. Dispositif suivant l'une quelconque des revendications précédentes, dans lequel ledit orifice de sortie (74) est prévu pour recevoir de façon étanche une autre communication de fluide près de l'extérieur dudit bloc de jonction commun, afin de constituer un chemin pour la communication de fluide.
EP83902012A 1982-06-24 1983-05-09 Dispositif de communication de fluide Expired - Lifetime EP0112356B2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US39178482A 1982-06-24 1982-06-24
US391784 1982-06-24
PCT/US1983/000678 WO1984000137A1 (fr) 1982-06-24 1983-05-09 Dispositif de communication de fluide

Publications (4)

Publication Number Publication Date
EP0112356A1 EP0112356A1 (fr) 1984-07-04
EP0112356A4 EP0112356A4 (fr) 1985-09-09
EP0112356B1 true EP0112356B1 (fr) 1988-08-31
EP0112356B2 EP0112356B2 (fr) 1995-12-27

Family

ID=23547936

Family Applications (1)

Application Number Title Priority Date Filing Date
EP83902012A Expired - Lifetime EP0112356B2 (fr) 1982-06-24 1983-05-09 Dispositif de communication de fluide

Country Status (5)

Country Link
EP (1) EP0112356B2 (fr)
AU (1) AU557821B2 (fr)
DE (1) DE3377867D1 (fr)
NO (1) NO840664L (fr)
WO (1) WO1984000137A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4718467A (en) * 1986-05-30 1988-01-12 Baxter Travenol Laboratories, Inc. Pumping module arrangement and manifold
US5334182A (en) * 1992-09-02 1994-08-02 Perry Creek Group Corporation Pulmonary artery catheter monitoring bridge
GB2503162B (en) 2011-03-23 2018-08-22 Nxstage Medical Inc Peritoneal dialysis systems and devices
EP4218709A1 (fr) * 2016-03-15 2023-08-02 Fresenius Kabi Deutschland GmbH Procede de fabrication d'une preparation medicamenteuse
EP3641850B1 (fr) 2017-06-24 2024-10-09 NxStage Medical Inc. Procédés de préparation de fluide de dialyse péritonéale
US11872337B2 (en) 2018-02-28 2024-01-16 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB695403A (en) * 1950-03-06 1953-08-12 Fritz Heinemann Improvements in or relating to closures for containers
US2814404A (en) * 1953-12-02 1957-11-26 Bryant W Griffin Closure for beaded containers
US3566930A (en) * 1968-05-02 1971-03-02 K N Enterprises Inc Means for sterilely transferring blood plasma, serum, biological or pharmaceutical fluids, and the like
US3565286A (en) * 1968-10-18 1971-02-23 Cryogenic Technology Inc Liquid programming and pumping apparatus
US3749285A (en) * 1971-09-13 1973-07-31 Haemonetics Corp Programmed liquid delivery system
US4006847A (en) * 1975-10-23 1977-02-08 Dooley Dynamics, Inc. Dispensing apparatus
US4184815A (en) * 1977-03-14 1980-01-22 Extracorporeal Medical Specialties, Inc. Roller pump rotor with integral spring arms
US4143853A (en) * 1977-07-14 1979-03-13 Metatech Corporation Valve for use with a catheter or the like
US4191183A (en) * 1977-10-31 1980-03-04 Barry Mendelson Mixing chamber for use in plural medical liquid intravenous administration set
US4197848A (en) * 1978-01-06 1980-04-15 Baxter Travenol Laboratories, Inc. Closed urinary irrigation site
US4347874A (en) * 1980-10-02 1982-09-07 Sullivan James J High speed sterile fluid transfer unit

Also Published As

Publication number Publication date
NO840664L (no) 1984-02-22
AU557821B2 (en) 1987-01-08
DE3377867D1 (en) 1988-10-06
EP0112356B2 (fr) 1995-12-27
WO1984000137A1 (fr) 1984-01-19
AU1702783A (en) 1984-01-26
EP0112356A1 (fr) 1984-07-04
EP0112356A4 (fr) 1985-09-09

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