Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/1407—Infusion of two or more substances
  • A61M5/1408—Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D19/00—Degasification of liquids
  • B01D19/0031—Degasification of liquids by filtration

Definitions

• the present invention relates to systems and equipment sets for the administration of medical liquids to a patient, and more particularly, to systems and equip- 5 ment sets for the sequential administration of a plurality of medical liquids employing a novel hydrophobic and hy- drophilic membrane valve providing a combined air barrier and liquid sequencing valve therefor.
• Liquids in ⁇ cluding amino acids, blood, dextrose, electrolytes, and. saline are commonly administered to patients over pro ⁇ longed periods of time. Generally, these liquids are ad ⁇ ministered from a glass bottle or plastic bag suspended
• the patient must receive an addi ⁇ tive or secondary liquid while the prolonged infusion is
• this secondary liquid should be administered through the same hypodermic needle to avoid unnecessary pain and trauma to the patient of additional venipunctures.
• this flow it is also preferable that the flow
• the secondary liquid admin ⁇ istered and the flow of the primary liquid resumed.
• the secondary liquid will be administered at a flow rate of 50 - 250 ml./hr.
• VENOSET piggyback sets allow the prolonged infusion of a primary liquid to be temporarily halted by means of a backcheck
• the primary object of the present invention is to provide a combined air barrier and liquid sequencing valve for the sequential administration of medical liquids at dual flow rates that will not draw air from the liquid containers when the liquids have been de ⁇ pleted.
• a gravitational flow system for the sequential administration of medical liquids to a patient including a primary liquid container, a primary tube, a secondary liquid container, a secondary tube, and a common tube all connected in fluid communica ⁇ tion to form a primary liquid flow path and a secondary liquid flow path.
• the primary liquid flow path includes the primary and common tube, while the secondary liquid flow path includes the secondary and common tubes.
• a secondary flow control means in the secondary liquid flow path for adjusting the flow rate of the secondary liquid and a primary flow control means on the primary tube for adjusting the flow rate of the primary liquid to a rate independent of the flow rate of the secondary liquid are provided.
• the primary tube includes a valve which allows primary liquid to flow from the primary container whenever the height of primary liquid is greater than or equal to the height of the secondary liquid in the system.
• the valve prevents primary liquid from flowing out of the pri- mary container whenever the height of the primary liquid is less than the height of the secondary liquid in the system.
• the valve is also impermeable by air when the primary liquid is depleted from the primary container.
• An air barrier in the secondary liquid flow path that is substantially impervious to air is provided to insure that no air is drawn from the secondary container when the secondary liquid is depleted.
• the secondary tube air barrier and primary tube valve are housed in a combined air barrier and liquid sequencing valve.
• FIG. 1 is a schematic block diagram of the efficacious system for the sequential administration of medical liquids at dual flow rates contemplated by this invention
• FIGS. 2 - 5 are front elevational views par- tially in cross-section illustrating the operation of a medical liquid administration equipment set embodying the system of FIG. 1 and employing a preferred combined air barrier and liquid sequencing valve, and
• FIG. 6 is a front elevational view of a por- tion of another medical liquid administration set embody ⁇ ing the system of FIG. 1 and employing an alternate ver ⁇ sion of the combined air barrier and liquid sequencing valve.
• FIG. 1 a schematic block diagram of the basic elements of the gravitational flow system for the sequential ad ⁇ ministration of medical liquids at dual flow rates con ⁇ templated by this invention.
• the diagram depicts a primary liquid container
• OMPI -5- diagram also depicts a secondary liquid container 13 that contains a secondary medical liquid to be administered to the patient for a relatively short period of time, during which time the administration of the primary liquid 5 will be temporarily interrupted.
• containers 11 and 13 can be glass bottles, plastic flexible bags, or any other suitable container.
• Primary container 11 and secondary container 13 are connected in fluid communication to a conventional
• the primary liquid flow path from primary container 11 to needle 15 comprises primary tube 17 and common tube 21.
• 15 13 to needle 15 comprises secondary tube 19 and common tube 21.
• the distal end of primary tube 17 is in fluid communication with primary container 11, preferably by means of a piercing pin 23 inserted into a puncturable
• Piercing pin 23 can have an integral drip chamber 25, and when container 11 is a glass bottle, as shown in the set of FIG. 2, an integral, filtered air vent 27.
• Such piercing pins, drip chambers and air vents are well known in the medical practice and
• the proximal end of primary tube 17 is joined in fluid communication to the distal end of common tube 21, preferably by a y-tube 29, it being understood that the primary, secondary and common legs of y-tube 29
• Primary tube 17 has a primary flow control 31 at any convenient loca ⁇ tion intermediate its ends for independently adjusting the rate of flow of the primary liquid .through the primary
• primary flow control 31 can be a roller clamp. However, it can be any other adjustable device that will reliably maintain a desired primary liquid flow rate.
• the distal end of secondary tube 19 is in fluid communication with secondary container 13, preferably, by means of a piercing pin 35 inserted into a puncturable closure of container 13.
• Piercing pin 35 can have an integral drip chamber 37, and when container 13 is a glass bottle, as shown in FIG. 2, an integral, filtered air vent 39.
• the proximal end of secondary tube 19 is joined in fluid communication to the distal end of common tube 21, preferably, by a y-tube 29.
• a secondary flow control 43 is disposed at any convenient location in the secondary liquid flow path.
• secondary flow control 43 can be a roller clamp. However, it can be any other adjustable device that can reliably maintain a desired secondary liquid flow rate.
• FIG. 1 A combined air barrier and liquid sequencing valve having a housing 32 is shown in FIG. 1.
• Housing 32 has first and second chambers 33, 41, as shown in FIGS. 2 - 6, that are formed by a vertical wall 34.
• First and second chambers 33, 41 each have inlet and outlet ports thereto through housing 32 that are respectively connected in fluid communication to the other portions of the primary or secondary tubes 17, 19.
• Primary tube 17 thus includes first chamber 33 of housing 32, while secondary tube 19 includes second chamber 41.
• First chamber 33 has valve means associated with its ports that allow primary liquid to flow from primary container 11 whenever the height of the primary liquid is greater than or equal to the height of the secondary liquid in the system of FIG. 1. Further, the valve means associated with first chamber 33 prevents the flow of primary liquid from primary container 11 whenever the height of the primary liquid is less than the height of the secondary liquid in the system. .
• the valve means associated with first chamber 33 is a hydrophilic membrane 38 which covers out ⁇ let port 36 at the top of first chamber 33.
• -7- inlet port 30 is located at the bottom of first chamber 33.
• first chamber 33 has its outlet port 36 at the bottom and its inlet port 37 at the top and inlet port 37 is provided a disk valve 38. It will be readily apparent that various other valves can be pro ⁇ vided to outlet 36 or inlet 37 of first chamber 33.
• Second chamber 41 of combined air barrier and liquid sequencing valve housing 32 as shown in FIGS. 2 - 6 preferably has an inlet port at its top and an out- let port at its bottom. Second chamber 41 has means associated with its ports that are substantially imper ⁇ vious to air while the set is in use and prevent the flow of air through the secondary flow path. As shown in FIG. 2, the outlet from second chamber 41 is covered by a hydrophilic membrane filter 45.
• Hydrophilic membranes 38, 45 are impermeable to air when wet, which they are during the use of the sets of this invention.
• the hydrophilic filters can be formed from materials such as a cellulose acetate mater- ial produced by the Millipore Filter Corporation of Bed ⁇ ford, Massachusetts or the Sartorius-Membranfilter GmbH of Weender Landstr, West Germany.
• float valve 47 which floats away from the outlet when liquid is present in second chamber 41, but seats or closes over the outlet when no liquid is present. It will be apparent to those skilled in the art that numerous other valves can be employed to perform the function of float valve 47, so long as the valve forms a barrier impermeable by air when no liquid is present in second chamber 41.
• the housing 32 of the sets shown in FIGS. 2 and 6 each include an air vent tube 47 having a slide clamp 49 and a filtered opening 50.
• opening 50 can be filtered by a hydrophobic membrane filter which is permeable by air, but not liquids.
• the hydrophobic filters can be formed of polyfluorotetraethylene, hexa- fluoropropylene/tetrafluoroethylene copolymer, or other
• FIG. 5 illustrates a hydrophobic filter
• slide clamp 49 can be eliminated, as shown in the set of FIG. 5, which includes both a hydrophobic filter over opening 50 and a hydrophilic membrane filter 51 between opening 50 and second chamber 41.
• the air vent can be eliminated altogether in those instances where the second chamber 41 can be primed through its inlet.
• FIGS. 2 - 6 Each embodiment of the system of FIG. 1 shown in FIGS. 2 - 6 includes a slide clamp 51 near the distal end of secondary tube 19 and a slide clamp 52 near the proximal end of common tube 21.
• the combined air barrier and liquid sequencing valve shown in FIG. 2 has an aperture in vertical wall
• Second chamber 41 has a reservoir 55 for liquid which has an open top located directly under the opening to second chamber 41.
• vertical wall 34 can be an inte ⁇ gral part of reservoir 55.
• the equipment sets embodying the system of FIG. 1 have been depicted and described as integral units of FIGS. 2 - 6. It is apparent, however, that the sets can be manufactured and assembled in sub ⁇ sets of the entire set and that each subset will accord ⁇ ingly be provided such resealable closures, piercing means, adapters, etc. as are necessary to permit their easy as- semblage into the complete set at an appropriate time.
• primary container 11 is suspended in space at a height above the patient by means of a hook 77 and stand 79. It will be apparent that other means for suspending the containers of this invention are well known.
• the set is initially primed by first closing all slide clamps 49, 51, and 52, if present. Piercing pin 23 is then inserted into the resealable closure of primary container 11. Primary flow control 31 is fully opened. If the set of FIG. 6 is being used, it will be inverted at this time. Slide clamp 52 is opened to allow primary liquid to flow through the primary liquid flow path and force all the air therefrom that might be forced into the patient. Slide clamp 52 is then closed. In the sets of FIGS. 2 and 5, air will pass through hydrophilic membrane 38 initially until the pri ⁇ mary liquid fills first chamber 33 and then wets hydro ⁇ philic membrane 38 as it passes through it.
• piercing pin 35 at the distal end of sec ⁇ ondary tube 19 can be inserted into the resealable clo- sure of secondary container 13, the proximal end of secondary tube 19 detached from y-tube 29, slide clamp 51 opened and secondary liquid allowed to flow through secondary tube 19 until it reaches the proximal end thereof. Slide clamp 51 is then closed and the proximal end of secondary tube 19 reattached to y-tube 29.
• Common tube 21 which preferably has an adapter at its proximal end open to the flow of liquid therefrom, is next connected to needle 15, which will generally have been already inserted into a vein of the patient.
• Slide clamp 52 will then be opened to allow primary liquid to flow through the primary liquid flow path to the pa ⁇ tient's vein.
• Primary flow control 31 is then adjusted to a setting that will provide the desired flow rate for a prolonged infusion of primary liquid into the patient, generally 10 - 150 ml./hr. As is well known in the medi ⁇ cal practice, that flow rate can be visually observed by viewing and counting drops passing through the primary drip chamber 25.
• Secondary container 13 is then suspended in space from stand 79 at a height substantially greater than the height of primary container 11. Secondary liquid will then immediately begin to flow through the secondary liquid flow path.
• the pressure of secondary liquid on the primary liquid at y-tube 29 will force the primary liquid against disk valve 38 closing inlet port 37 to first chamber 33 and preventing the flow of pri ⁇ mary liquid from primary container 11.
• Secondary flow control 43 is then adjusted to a desired flow rate, typically 50 - 250 ml./hr., for the secondary liquid, which will then flow until the liquid in secondary con- tainer 13 is depleted. It will be apparent that the initial liquid flowing from secondary tube 19 will be the primary liquid with which it was primed.
• piercing pin 35 of secondary tube 19 is inserted into the resealable closure of secondary con ⁇ tainer 13. If the portion of secondary tube 19 above the inlet port to second chamber 41 is detachable, it can then be detached and slide clamp 51 opened to force the air from that portion of tube 19. Slide clamp 51 is then closed and the tubjing attached to the inlet port to second chamber 41.
• Secondary container 13 is then suspended in space at a height substantially greater than the height of primary container 11. The set will now be in the mode illustrated in FIG. 2.
• hydro ⁇ philic membrane 38 and the air displaced from second cham ⁇ ber 41 block the flow of primary liquid from primary con ⁇ tainer 11 through the primary liquid flow path as long as the height of secondary liquid in the system is greater than that of the primary liquid.
• Secondary flow control 43 is then adjusted to a desired flow rate, typically 50 - 250 ml./hr., for the secondary liquid, which will then flow until the liquid in secondary container 13 is depleted. It will be appar ⁇ ent that the initial liquid flowing from secondary tube 19 will be the liquid with which it was primed.
• the primary flow rate is independent of the sec ⁇ ondary flow rate. In those instances where it is less than or equal to the secondary flow rate, both primary and secondary liquid will flow through common tube 21, until air reaches the air barrier in second chamber 41. Then only primary liquid will enter common tube 21. The air barrier in second chamber 41 then prevents air from being drawn into common tube 21 and eventually to the patient's vein.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Veterinary Medicine (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Biomedical Technology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Emergency Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Applications Claiming Priority (6)

Related Child Applications (1)

Publications (2)

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Family Applications Before (1)

Country Status (5)

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• 1980
  • 1980-01-23 EP EP82110268A patent/EP0089404A1/fr not_active Withdrawn
  • 1980-01-23 WO PCT/US1980/000071 patent/WO1980001754A1/fr not_active Application Discontinuation
  • 1980-01-23 JP JP50056280A patent/JPS56500240A/ja active Pending
  • 1980-01-25 CA CA344,432A patent/CA1127042A/fr not_active Expired
  • 1980-02-05 AU AU55235/80A patent/AU533881B2/en not_active Expired - Fee Related
  • 1980-09-10 EP EP19800900453 patent/EP0025042A4/fr not_active Withdrawn

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