Classifications

• • 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2093—Containers having several compartments for products to be mixed
• • 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/202—Separating means
  • A61J1/2027—Separating means having frangible parts

Definitions

• the present invention relates to multiple chamber solution con- 5.
• tainers and more particularly relates to a flexible container con ⁇ struction for medical solutions which facilitates inspection of chamber seal integrity.
• Another multiple chamber, flexible-walled container suitable for the separate storage of two liquids Is described in U.S. Patent No. 4,396,383 to Hart, assigned to the assignee of the present inven ⁇ tion.
• Such multiple chamber medical fluid containers are especially useful for storing and mixing two supply solutions which when mixed form a single medical solution which itself is unsuitable for storage over extended time periods. Examples of medical substances which may not be combined until just prior to use include
• dextrose solution and heparin (1) dextrose solution and heparin and (2) dextrose solution and amino acids.
• dextrose solution and amino acids There are many other medical liquids which may not be combined until just before delivery to the patient.
• the double chamber container is advantageous in that it provides closed system for mixing the two liquids, eliminating the chance of contamination which would otherwise be present if the two medical substances were to be combined from two separate sources, such as might be done in a hospital pharmacy.
• Flexible plastic containers such as the single chamber VIAFLEX container sold by Travenol Laboratories, Inc. of Deerfield, Illinois, provide a cost effective means for solution storage.
• Various plastics can be used, such as polyvinyl chloride sheeting. Two sheets of the plastic may be effectively sealed by such means as a heat seal to form the container.
• the present invention is directed to a multiple chamber con ⁇ tainer having a leak detection compartment.
• Flexible plastic sheet ⁇ ing defines first and second chambers, at least one of which con ⁇ tains a liquid substance.
• a chamber-communicating means is disposed between the first and second chambers and defines a selectively openable flow path between the chambers.
• a normally empty leak detection compartment encloses the chamber-communicating means between the two chambers, providing two related principal - advantages. Any liquid which leaks between the chamber-communicat- ⁇ ing means and the outer container wall formed by the sheeting enters the leak detection compartment, enabling the liquid to be detected by various means, such as visual inspection. Also, liquid which leaks out of one chamber is prevented from entering the other chamber.
• the leak detection compartment may include permanent openings such that liquid passing into the compartment immediately passes out of the container into an overpouch typically used as a dust cover.
• leaks may be detected by visual inspec- tion for moisture in the overpouch after autoclavlng of the con ⁇ tainer.
• the present invention is further directed to a method of detect ⁇ ing a leak in a multiple chamber container.
• FIG. 1 is a perspective view of the container of the present invention.
• Fig. 2 is an exploded view of a chamber-communicating means, including the flexible plastic tube and the frangible closure.
• Fig. 31 s a perspective view of the assembled chamber-com- munieating means.
• Fig. 4 is a top plan view of the manufacturing procedure for the container.
• Fig. 51 s a side elevational view of the manufacturing procedure for the container.
• the container 34 of the present invention 1 s Illustrated in Fig. 1.
• the container 34 is stored within an overpouch 35 and has a con- tainer wall formed from flexible plastic sheets 36, 38 which define first and second chambers 40, 42.
• the chambers 40, 42 contain first and second substances 44, 46, respectively. At least one of the substances 44, 46 is a liquid. In the drawing, both substances are liquids.
• the first substance 44 may be heparin and the - second substance 46 may be dextrose solution.
• the two sheets 36, 38 are sealed together such as by a heat seal 48 to further define the container wall and the first and second chambers 40, 42.
• a first chamber fill port 50 communicates with the first chamber 40.
• An injection site 52 and an administration port 54 communicate with the second chamber 42.
• First fill port 50, injection site 52 and administration port 54 are disposed and secured between the first and second sheets 36, 38 in conventional manner by heat seal- ing the sheets about the tubes comprising the ports 50, 54 and the injection site 52.
• the injection site 52 includes a polyisoprene situs 56 which may be pierced by a needle for addition of medicament.
• the administra ⁇ tion port 54 may include a pierceable diaphragm (not shown) which is pierced by the spike or cannula of a parenteral fluid administration set.
• Chamber-communicating means is disposed between the first and second chambers 40, 42.
• the chamber-communicating means is the chamber-communicating assembly 61, which is best shown in Figs. 2 and 3.
• the assembly 61 includes a flexible tube 58 in which is mounted a frangible closure 60.
• the assembly 61 is sealed between the sheets 36, 38.
• the heat seal 48 between the flexible pl stic sheets 36, 38 is a strong, secure seal.
• the heat seal portion 64 about the flexible tube 58 is both a harder seal to make, because of seal conformance to a circular configuration, and a more critical seal to maintain, because It effectively separates the substances 44, 46 in the top and bottom chambers 40, 42. Because of the need for the heat seal portion 64 between the otherwise substantially parallel sheets 36, -r-
• a leak detection compartment 62 is disposed between and partially defined by the flexible sheets 36, 38, between the first t ⁇ and second chambers 40, 42.
• the sheets 36, 38 form the wall of the detection compartment 62.
• the leak detection compartment encloses the chamber-communicating means which in the preferred embodiment is the assembly 61.
• the leak detection compartment 62 is defined by a seal such as the heat seal portion 64 between the first and second sheets 36, 38 and between each of the sheets and the tube 58.
• the leak detection compartment 62 in the preferred embodiment includes defined openings 66 in the first and second sheets 36, 38 to the container-exterior. However, only one opening 66 is necessary in this embodiment and it may be limited to only one of the two sheets.
• the frangible closure 60 includes a hollow, tubular portion 68 and a stem 70 integral with the hollow, tubular portion 68 at a thin wall portion 72.
• the frangible closure 60 is mounted in the tube with the hollow tubular portion 68 near the first tube end 63 and with the stem 70 near the second tube end 65.
• the tube 58 may include sidewall openings 59 around the stem 70 of the frangible closure 60 for increased fluid flow rate after the frangible closure 60 has been broken.
• the frangible closure 60 acts as a valve.
• the stem 70 includes extended vanes 74 which press against the inside wall of the tube 58 to maintain the stem 70 within the tube even after the stem is broken away from the hollow tubular portion 68.
• the closure 60 and tube 58 may be sealed together by inserting a metal mandrel within the hollow tubular por ⁇ tion 68 and bringing a sealing die (not shown) of conventional con ⁇ struction around the tube 58 opposite the hollow tubular portion 68.
• RF seals are formed by the application of pressure as well as by RF energy.
• the application of sufficient pressure forms an indentation or channel 76 in the sidewall 78 of the tube 58, about the entire circumference of the tube, and corresponding ridges 80 in the side- wall 78 on both sides of the channel 76.
• the presence of the channel 76 and ridges 80 is highly desirable in the container of the invention.
• 1t 1s mounted on a mandrel 82 extending from a stop 84, as seen in Fig. 4.
• the hollow tubular portion 68 rests about the mandrel 82.
• a container subassembly 86 is then loaded about the mandrel 82.
• the container subassembly 86 includes the majority of the peripheral heat seal 48 as well as por ⁇ tions of the heat seal 48 which define the interior walls of the first and second chambers 40, 42.
• the container subassembly 86 may include void areas 88 which serve to further separate the first and second chambers 40, 42.
• the container subassembly 86 also includes a first chamber opening 90 and a second chamber opening 92 at which the first and second sheets 36, 38 are not yet sealed.
• the container subassembly 86 is mounted about the mandrel 82 with the mandrel 82 extending through the first chamber opening 90.
• the container subassembly 86 is urged onto the mandrel, with the assembly 61 thereabout, until the first chamber end 94 of the con- tainer subassembly 86 hits the stop 84.
• Proper sizing of the con- tainer length, the mandrel length and stop assure that the assembly 61 is accurately placed within the container subassembly 86.
• heat seal dies 96 are then urged against both of the flexible sheets 36, 38 to form the seal portion 64 which defines the leak detection compartment 62.
• the heat seal portion 64 extends from the heat seal 48 previously made on the container sub ⁇ assembly 86.
• the dies 96 form the seal 64 about the entire circumference of the tube 58, between the tube 58 and the flexible sheets 36, 38, as well as between the flexible sheets 36, 38 them- selves.
• the seal portion 64 thus formed completely separates the first and second chambers 40, 42.
• the assembly 61 is fairly precisely placed within the container subassembly 86. This is to ensure that the channel 76 about the entire circumference of the tube 58 is within the compartment 62 defined by the heat seal 64. Thus, within the compartment 62 the flexible sheets 36, 38 do not contact the tube 58.
• the compartment 62 although disposed on both sides of the tube 58 as seen in Fig. 1, is one contiguous volume.
• the first chamber fill port 50, the injection site 52 and the administration port 54 may be inserted between the sheets 36, 38 and sealed thereto in conventional manner.
• the first chamber 40 may be filled with the first substance 44 through the tube 50, which may then be permanently sealed, such as by a heat seal.
• the second chamber 42 may be filled with the second substance 46 through either the injection site 52 or administration port 54 before final closure of the site 52 and tube 54.
• the leak detection compartment 62 includes opening 66 to the container-exterior.
• OMPI . WIPO ,A» may be formed anytime after formation of the compartment 62 itself by a cutting or punching operation.
• the container 1s completely manufactured and filled and sealed it is ready for autoclaving, which 1s a common means for sterilizing medical liquids.
• flexible plastic medical solution containers are placed in plastic overpouches. These over- pouches serve as dust covers and/or moisture transmission barriers to limit moisture loss from the container through the container wall during extended storage periods.
• the overpouch 35 is then typically sealed with the container therein and placed in an autoclave where it is subjected to a temperature of about 250 degrees Fahrenheit for a period of about one hour, for example, to sterilize the container contents.
• the temperature and time may vary, especially depending on the volume of the container.
• the steam sterilization under pressure procedure provides the most stringent test of seal integrity for the container.
• Patent No.4,396,383 and U.S.S.N. 246,479 for example, an Improper seal between two chambers could not be detected because liquid flowing between any unintentionally remaining passage between the first and second chambers would simply flow into the other chamber. Thus, any existing leak might not be noticed.
• any Improper seal between the flexible sheets 36, 38 and the flexible tube 58 will be detected because moisture will pass through any seal failure passage into the leak detection compartment 62 and then out the defined openings 66 into the overpouch 35, where the moisture may be visually detected after the steam sterilization cycle has been completed.
• the overpouches are clear enough to detect the collection of any moisture within the pouch. Those containers which do not have moisture within the overpouches have a proper seal between the tube 58 and the sheets 36, 38.
• the container 34 of the present invention may be utilized by the end user, such as a nurse or other hospital personnel, by bending the tube 58 from outside the container 34 as described above. Alternate compression of the chambers 40, 42 forces liquid between
• the defined open- l'ngs 66 are not provided. Moisture passing through any improper seal about the tube 58 will be retained in the leak detection compartment 62 instead of passing into the overpouch 35.
• This embodiment may not be preferred from the point of view of leak detection within the manufacturing facility because visual inspec- tion will then have to be made through the wall of the leak detec ⁇ tion compartment 62 as well as through the wall of the overpouch. Opening of the overpouch and removal of the container to view the compartment 62 is an extra step and typically the container 34 would be defined as a destroyed product if removal from the overpouch were made after steam sterilization, even though the container contents are sterile.

Landscapes

• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Bag Frames (AREA)
• Package Specialized In Special Use (AREA)
• Details Of Rigid Or Semi-Rigid Containers (AREA)

Priority Applications (1)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

Country Status (6)

Cited By (1)

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Citations (13)

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• 1983
  • 1983-10-21 US US06/544,190 patent/US4507114A/en not_active Expired - Lifetime
• 1984
  • 1984-09-20 JP JP59503718A patent/JPS61500219A/ja active Granted
  • 1984-09-20 DE DE3486278T patent/DE3486278T2/de not_active Expired - Lifetime
  • 1984-09-20 EP EP19840903728 patent/EP0159342B1/en not_active Expired - Lifetime
  • 1984-09-20 WO PCT/US1984/001504 patent/WO1985001716A1/en active IP Right Grant
  • 1984-10-19 CA CA000465980A patent/CA1237028A/en not_active Expired

Patent Citations (13)

Non-Patent Citations (1)

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