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WO2001026719A1 - Solution parenterale tolerant la pression et contenant pour le sang destine a une cassette de chauffage - Google Patents

Solution parenterale tolerant la pression et contenant pour le sang destine a une cassette de chauffage Download PDF

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Publication number
WO2001026719A1
WO2001026719A1 PCT/US2000/002630 US0002630W WO0126719A1 WO 2001026719 A1 WO2001026719 A1 WO 2001026719A1 US 0002630 W US0002630 W US 0002630W WO 0126719 A1 WO0126719 A1 WO 0126719A1
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WO
WIPO (PCT)
Prior art keywords
layers
layer
fluid container
fluid
sheet
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.)
Ceased
Application number
PCT/US2000/002630
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English (en)
Inventor
Scott D. Augustine
Randall Charles Arnold
Keith Jay Leland
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.)
Augustine Medical Inc
Original Assignee
Augustine Medical Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Augustine Medical Inc filed Critical Augustine Medical Inc
Priority to AU27506/00A priority Critical patent/AU2750600A/en
Publication of WO2001026719A1 publication Critical patent/WO2001026719A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61J1/05—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
    • 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
    • A61M5/44—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 having means for cooling or heating the devices or media
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/04—Dielectric heating, e.g. high-frequency welding, i.e. radio frequency welding of plastic materials having dielectric properties, e.g. PVC
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261—Enclosing tubular articles between substantially flat elements
    • B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/712—Containers; Packaging elements or accessories, Packages
    • B29L2031/7148—Blood bags, medical bags

Definitions

  • This invention is generally related to parenteral fluid warmers and, more particularly, to a multi-layered parenteral fluid container for use in a warming cassette that is received in a warming device.
  • Plastic films have been used to make heat exchanger cassettes for parenteral fluid and blood warmers. Typically, two sheets of such film are joined to form a container with a fluid channel between the sheets.
  • a warming cassette incorporates such a fluid container with other elements that impart structural support to the container and provide means for mating the container to a warming device. In use, the cassette is placed between the heated metal plates of a warming device and, as fluid flows through the channel in the container, it is warmed by heat conducted from the heated plates.
  • the material of a plastic film used in manufacturing a fluid container for a cassette is usually polyvinyl chloride (PVC), polyethylene or polypropylene.
  • the film is a single layer of such material (a monolayer).
  • the advantage of monolayer construction is that the film is very inexpensive and readily available.
  • thermo- sealing is a particularly desirable joining technique that is adaptable to high volume, web-based manufacture.
  • Thermo-sealability is usually optimized when the film material has a low melting point.
  • most of the inexpensive and common plastic film materials have a low melting point.
  • simple heat sealing with a heated platen melts the plastic film to the heated platen, destroying the film and fouling the platen. Therefore, to use low melting point plastic films for the manufacture of parenteral fluid containers, the films require resealing with radio frequency (RF), ultrasonic (US) welding, or other additional manufacturing steps and equipment, rather than relying on faster, cheaper, and simpler heat sealing methods.
  • RF radio frequency
  • US ultrasonic
  • a monolayer of low-melt point plastic film can be made relatively thick (greater than 8 mil) in order to make the fluid container strong enough to withstand pressurization of the fluid contained within it.
  • these thicker, pressure tolerant, plastic films exhibit high thermal resistance.
  • the thicker plastic films are very effective thermal insulators, preventing efficient heat transfer to the fluid.
  • High melt-point plastic films are frequently stronger and, therefore, may be a thinner material. However, most of the stronger, harder plastic films are generally difficult to join using thermo- sealing.
  • container sheet material Another desirable characteristic of container sheet material is a low coefficient of friction to support easy, sliding travel of a cassette between the plates of a warming device.
  • the common, lower melting point materials such as PVC
  • PVC polyvinyl vapor deposition
  • these low melting point plastics tend to be relatively "sticky" to the touch, especially when heated. They have a high coefficient of friction and can stick to the metal plates of a warming device, making insertion and removal of a cassette much more difficult. Therefore, to insure that a cassette can easily slide into the narrow gap between the heated metal plates of a warming device, a fluid container made with a harder plastic film, having a low coefficient of friction, would seem to be indicated.
  • the stronger, harder plastic films generally do not thermo-seal very well.
  • the film material for a parenteral fluid container for a warming cassette could be thermo-sealable for a strong, reliable seal and for fast, inexpensive, web manufacturing.
  • the material had a low coefficient of friction even when warm, to support easy removal and insertion between the heated plates of a warming device. It would be especially advantageous if the material had all of the above-mentioned favorable characteristics.
  • thermo-seals It would also be advantageous if a thin layer of the film material was strong enough to withstand high inflation pressures and resist thinning at the edges of the thermo-seals.
  • a parenteral fluid or blood container for a warming cassette used in a parenteral fluid warming system comprises a first sheet including a plurality of layers and a second sheet including a plurality of layers.
  • the first sheet is joined to the second sheet to form a fluid container with a fluid channel.
  • the fluid container's fluid channel conducts fluid between the sheets, while the sheets contact a heat source and conduct heat to warm the fluid as it flows through the channel.
  • the first sheet includes at least a first layer and a second layer in a laminated structure, while the second sheet includes at least a third layer and a fourth layer in a laminated structure.
  • the first and third layers are flexible films formed from a first material characterized by a low coefficient of friction and a first melting point.
  • the second and fourth layers are formed from a second material having a second melting point which is lower than the first melting point. This permits joinder of the sheets by thermo-bonding the second and fourth layers at a temperature that melts the second material of these layers, without melting the first material of the first and third layers.
  • the second layer is joined to the fourth layer to form the fluid channel between the first and second sheets.
  • the first material can be selected from the group of materials consisting of polyester, polyamide, polyethylene glycol terephthalate, metal foils, and ionomer resins
  • the second material can be selected from the group of materials consisting of polyolefin, polyethylene, polypropylene, polyvinyl chloride (PVC), polyurethane, and ethyl vinyl acetate (EVA) co-polymer.
  • PVC polyvinyl chloride
  • EVA ethyl vinyl acetate
  • the invention is embodied in a method for forming a fluid container for a warming cassette to be used in a fluid warming system.
  • the method comprises the steps of: forming a first sheet having at least first and second flexible layers; forming a second sheet having at least third and fourth flexible layers; and joining the first and second sheets by a seal formed between the second and fourth layers.
  • Forming the first sheet can include joining the first and second layers to form a first laminated sheet structure
  • forming the second sheet can include joining the third and fourth layers to form a second laminated sheet structure.
  • the first and third layers are films of a first material having a low coefficient of friction and a first melting point.
  • the second and fourth layers are films of a second material having a lower melting point than the first melting point.
  • Joining the first and second sheets includes joining the second and fourth layers by a thermal bond between those layers.
  • Fig. 1A is a detailed illustration of Section C of Fig. 1 showing a fluid connector.
  • Fig. 2 is a more detailed assembly depiction of the fluid container of Fig. 1.
  • Fig. 3 depicts the fluid container of Fig. 2 with the first and second sheets being joined to each other.
  • Fig. 4a is an end view of the fluid container of Fig. 3, showing the layer outside edges.
  • Figs. 4b 1 through 4b3 depict the fluid container 10 where the layers are of different sizes.
  • Figs. 4c 1 and 4c2 depict another alternate embodiment edge alignment.
  • Fig. 4d depicts a cutoff sectional view of another alternate embodiment edge alignment.
  • Fig. 4e depicts a cutoff sectional view of another alternate embodiment edge alignment.
  • Fig. 5 depicts the fluid container of Fig. 1, where the first sheet is comprised of three layers.
  • Figs. 6a and 6b detail the inlet/outlet ports of the fluid container of Fig. 1.
  • Fig. 7 illustrates the first port of Figs. 6a and 6b with IV connection tubing.
  • Fig. 8 is a flowchart illustrating the present invention method for forming a cassette fluid container.
  • a parenteral fluid container in a warming cassette according to this invention is provided by joining at least two sheets, with each sheet including two or more layers of synthetic films. Typically, in each sheet at least one layer is functionally a structural layer, and at least a second layer is functionally a thermo- sealable layer.
  • Fig. 1 is a perspective illustration of the parenteral fluid or blood container ("fluid container") 10 of this invention.
  • the fluid container 10 is used in a warming cassette of a parenteral fluid warming system 12.
  • a typical fluid warming system could include a warming unit with two heating plates 14 and 16.
  • the fluid container 10 is incorporated into a cassette structure (not shown), which adds the element of rigidity to the fluid container 10.
  • the cassette structure is inserted between plates 14 and 16 to heat the contents of the fluid container 10.
  • the cassette and the fluid container 10
  • the cassette could be warmed by convection in a stream of heated air, or by conduction in a bath of heated fluid.
  • two sets of multi-layered sheets are positioned so that thermo-sealable layers are in opposition to and face each other.
  • the outside exposed surfaces of the fluid container 10 are on the structural layers, or some additional layer, but not on the thermo-sealable layers.
  • a heat sealing platen, RF platen, or US horn is applied to one or both of the structural layer at a temperature which is above the melting point of the material of thermo-sealable layers, but below the melting point of the material of the structural layers.
  • the thermo-sealable layers are melted together outside of channel pattern to form the fluid container with a fluid channel 11 defined therebetween.
  • Fig. 1A is a detailed illustration of Section C of Fig. 1 showing a fluid connector 110.
  • the connector 1 10 and another connector 130 each communicate with a respective end of the fluid channel 11. These elements are described in more detail below, both as to construction and function.
  • Fig. 2 is a more detailed assembly depiction of the fluid container 10 of Fig. 1.
  • a first sheet 20 is shown, including a plurality of flexible film layers; two layers 22 and 24 of the first sheet 20 are shown.
  • a second sheet 26 includes a plurality of layers, with layers 28 and 30 of the second sheet being shown.
  • the first sheet 20 overlies, and is at least partially joined to the second sheet 26 by a seal to form a fluid channel therebetween.
  • the pressure tolerance of fluid container 10 is generally improved by using multiple layers of film.
  • the first layer 22 has an outside surface 34 and an inside surface 36; the second layer 24 has an outside surface 38 and an inside surface 40.
  • the third layer 28 has an outside surface 44 and an inside surface 46; the fourth layer 30 has an outside surface 48 and an inside surface 50.
  • the designation of surfaces as inside or outside is arbitrary and not meant to imply that the present invention is limited to a rigidly specific order or orientation.
  • Fig. 3 depicts fluid container 10 of Fig. 2 with first and second sheets 20 and 26 being joined to each other.
  • the first sheet 20 includes the first layer 22 and the second layer 24, with the second layer 24 being laminated to the first layer 22. That is, the first and second layers 22 and 24 are bonded to form the first sheet 20 as a laminated structure.
  • the second sheet 26 includes the third layer 28 and the fourth layer 30, with the fourth layer 30 being bonded to the third layer 28 to form the second sheet 26 as a laminated structure.
  • the second layer 24 is joined to the fourth layer 30 outside of a channel pattern to form the fluid channel 11 between the first and second sheets 20 and 26.
  • Fig. 3 also illustrates the form of the fluid channel 11.
  • the fluid channel 11, in this figure, is indicated with dotted lines.
  • the second and the fourth layers 24 and 30 are thermally bonded in a pattern to create the fluid channel 1 1, which in the figure, has a se ⁇ entine pattern.
  • the present invention is not limited to any particular fluid channel shape.
  • a bond can be made entirely across the surface of a layer. Alternately, layer edges are bonded to create a seam, or a seam pattern may be established across the layer surfaces.
  • the first and third layers 22 and 28 (hereinafter, the "structural layers”) generally serve two pu ⁇ oses.
  • the layers 22 and 28 are made from a relatively strong plastic or foil film material. A thin layer of the material is adequate to provide the necessary strength and without a significantly sacrificing thermal conductivity.
  • the structural layers 22 and 28 have a melting point that is significantly higher than the thermo-sealable material of the second and fourth layers 24 and 30 (hereinafter, the "thermosealable layers”). The temperature that is adequate to melt and seal the thermosealable layers 24 and 30 is less than the melting point of the structural layers 22 and 28.
  • thermo-sealing process may be applied to the structural layers 22 and 28, which then transfer the heat to the adjacent thermosealable layers 24 and 30.
  • the thermo-sealable layers 24 and 30 never directly contact the heat source and, therefore, they cannot melt onto and foul the heat source during manufacturing. This vastly simplifies the manufacturing of the fluid container by allowing basic heat sealing techniques to be used, rather than RF or US welding. Additionally, since the melting temperature of the structural layers 22 and 28 is not reached, the structural layers 22 and 28 do not melt and thin at the edge of the thermal seal. Therefore, the structural layers 22 and 28 still retain their full strength after heat sealing the thermosealable layers 24 and 30.
  • first and third (structural) layers 22 and 28 are formed from a first material having a first melting point
  • second and fourth (thermosealable) layers 24 and 30 are formed from a second material having a second melting point which is lower than the first melting point.
  • Reference designator 72 represents the application of heat to the first and third layers 22 and 28, respectively. The difference in melting points between the two materials permits the second and fourth layers 24 and 30 to be joined by a thermal bond.
  • the first and second sheets 20 and 26 may be formed by extrusion coating. That is, the second layer 24 is formed on the first layer 22 through an extrusion coating process. Likewise, the third and fourth layers 28 and 30 may be formed by extrusion coating.
  • first and second layers 22 and 24 may be laminated by adhesive bonding, as may the third and fourth layers 28 and 30.
  • first and second layers 22 and 24 may be laminated by solvent bonding, as may the third and fourth layers 28 and 30.
  • first and third layers 22 and 28 are formed from a first material having a first hardness
  • second and fourth layers 24 and 30 are formed from a second material having a second hardness less than the first hardness.
  • first and third layers 22 and 28 are formed from a first material having a first susceptibility to stretching, while the second and fourth layers are formed from a second material having a second susceptibility to stretching greater than the first susceptibility.
  • this property of the structural layers 22 and 28 provides structural integrity.
  • the first and third layers 22 and 28 are formed from a first material having a first coefficient of friction, while the second and fourth layers 24 and 30 are formed from a second material having a second coefficient of friction greater than the first coefficient of friction.
  • the lower coefficient of friction of the structural layers 22 and 28 permits fluid container 10 to be more easily inserted between warming plates 14 and 16 (see Fig. 1).
  • the first material may be selected from the group of materials consisting of polyester, polyamide (Nylon®, DuPont), polyethylene glycol terephthalate (Mylar®, DuPont), metal foils, and ionomer resins (Surlyn®, DuPont). Many other unnamed materials are also suitable.
  • the second material may be selected from the group of materials consisting of polyolefin, polyethylene, polypropylene, polyvinyl chloride (PVC), polyurethane, and ethyl vinyl acetate (EVA) co-polymer. Many other unnamed materials are also suitable.
  • Fig. 4a is an end view of the fluid container 10 of Fig. 3, showing the layer outside edges.
  • Fig. 4a depicts an embodiment where the layers, and layer edges align.
  • the second and fourth layers 24 and 30 have outside edges 80 and 82, respectively.
  • the edges 80 and 82 extend all the way around the perimeter of the second and fourth layers 24 and 30.
  • first and third layers 22 and 28 have outside edges 84 and 86, respectively.
  • edges 84 and 86 extend all the way around the perimeter of the first and third layers 22 and 28.
  • the first, second, third, and fourth layers 22, 24, 28, and 30 are depicted as having substantially equal sizes, meaning the surface area of the layers 22, 24,
  • Figs. 4b 1 through 4b3 depict the fluid container 10 where the layers 22, 24, 28, and 30 are of different sizes.
  • Fig. 4bl is a cutoff section view depicting thermosealable layers 24 and 30 having a larger size (larger surface area) than structural layer 22 and 28, so that outside edges 80 and 82 are shown extending, at least partially, past the outside edges 84 and 86.
  • layers 22, 24, 28, and 30 are rectangular with outside edges 80 and 82 extending beyond outside edges 84 and 86 (not shown) around all four sides 87, 88, 89, and 90, as shown in Fig. 4b2.
  • edges 80 and 82 only extend beyond edges 84 and 86 on either one, two, or three sides.
  • Fig. 4b3 depicts an alternative where only portions of second and fourth layers 24 and 30 are formed to be larger size than first and third sheets 22 and 28. That is, sheets 24 and 30 have edges 80 and 82 formed into tab sections.
  • the invention is not limited to any particular shape of tabs, number of tabs, or the placement of tabs on any particular side of the sheet.
  • edges 80 and 82 past edges 84 and 86 results in the formation of exposed surfaces 91a and 91b.
  • the surfaces 91a and 91b are used to bond the fluid container 10 to a frame structure (not shown) in the construction of a warming cassette.
  • the thermosealable property of the second and fourth layers 24 and 30 permits a convenient bonding process for this pu ⁇ ose.
  • Figs. 4c 1 and 4c2 depict another alternate embodiment edge alignment.
  • Fig. 4c 1 is a cutout section view of the fluid container 10 where the edges 84 and 86 extend, at least partially, past the edges 80 and 82.
  • the preferred embodiment of the invention includes layers 22, 24, 28, and 30 being rectangular, with sheets 22 and 28 being of a larger size (greater surface area) than thermosealable sheets 24 and 30. Therefore, the outside edges 84 and 86 extending beyond outside edges 80 and 82 around all four sides 87, 88, 89, and 90, as shown in Fig. 4b2.
  • edges 80 and 82 only extend beyond edges 84 and 86 on either one, two, or three sides.
  • layers 22 and 28 can be formed into tabs of various shapes and placements,
  • edges 84 and 86 past edges 80 and 82 results in the formation of exposed surfaces 91a and 91b.
  • the surfaces 91a and 91b are used to bond the fluid container 10 to a frame structure (not shown) in the construction of a warming cassette.
  • Fig. 4d depicts a cutoff sectional view of another alternate embodiment edge alignment.
  • first layer 22 is a larger size (as measured in area) than sheets 24, 28, and 30.
  • Edge 84 extends, at least partially, past the edges 80, 86, and 82.
  • the extension of edge 84 past edges 80, 82, and 86 results in a surface 91a which can be used for bonding to the support frame in some aspects of the invention.
  • the edge 84, and therefore mating surface 91a extends around all four sides of layer 22.
  • the edge 84 extends around one, two, three sides, or is formed into various tabs. Obviously, the above description would also apply to the formation of third sheet edge 86, instead of first sheet edge 84.
  • Fig. 4e depicts a cutoff sectional view of another alternate embodiment edge alignment.
  • the first and second layers 22 and 24 are larger in size than the third and fourth layers 28 and 30.
  • the edges 84 and 80 extend, at least partially, past the edges 82 and 86.
  • the extension of edges 84 and 80 past edges 82 and 86 results in surface 91a, which can be used for bonding to the support frame in some aspects of the invention.
  • the edges 84 and 80, and therefore the mating surface 91a extends around all four sides of layers 22 and 24.
  • the edges 84 and 80 extend around one, two, three sides, or are formed into various tabs. Obviously, the above description would also apply to the formation of third and fourth sheet edges 82, instead of first and second sheet edges 84 and 80.
  • the second layer 24 has a thickness 92 in the range of approximately 0.5 to 3.5 mils.
  • the fourth layer 30 has a thickness (not shown) that is similar to the thickness of second layer 24.
  • the first layer 22 has a thickness 94 in the range of approximately 0.5 to 1 mil.
  • the third layer 28 has a thickness (not shown) that is similar to thickness 94 of first layer 22.
  • the first sheet 20 has a thickness 96 in the range of approximately 1 to 4 mils, and the second sheet thickness (not shown) has approximately the same thickness.
  • the first and second sheets 20 and 26 have a combined thickness 98 in the range of approximately 2 to 8 mils.
  • the third layer 28 can be omitted altogether from the construction of the fluid container.
  • the advantage of thermally bonding the second and fourth layers 24 and 30 by application of heat through the first layer 22 can be maintained by provision of a cooled roller or a disposable silicone sheet beneath the fourth layer. Some sacrifice is made in an increased coefficient of friction by exposure of the fourth sheet 30. However, the benefit gained is increased thermal conductivity to the fluid channel by deletion of the third layer 28.
  • Fig. 5 depicts an embodiment of the fluid container 10 of Fig. 1 where the first sheet 20 is comprised of three layers. While a preferred embodiment of the invention envisions a sheet of two layers, other designs are contemplated. If more than two layers are used, the previously noted design characteristics may be divided among the various layers. For example, a sheet comprised of three or more layers, may have an external layer made of a thermosealable material in order to support thermal bonding to a plastic frame or support structure. Further, certain types of plastics are better for bonding to printing ink, others for solvent bonding. A layer of aluminum foil may be added to either or both sheets to reduce moisture vapor transmission through the plastic materials of the sheets. As used herein, the word "layer” implies a relatively flexible film material, as opposed to a coating of adhesive between first and second layers 22 and 24, for example.
  • the first sheet 20 may further include a fifth layer 100, having an inside surface 102, overlying the second layer's outside surface 38.
  • the fifth layer 100 directly overlies the second layer 24, between layers 22 and 24.
  • the fifth layer's inside surface 102 overlies the first sheet's outside surface 34. This permits the fifth layer 100 to be removed from the fluid container 10.
  • the fifth layer 100 including markings (not shown) used to identify fluid container 10. The markings may be visible and decipherable by eye, or may be a bar code, or identifiable through other electronic means.
  • the first layer 22 is formed from a first material having a first resistance to moisture
  • second layer 24 is formed from a second material having a second resistance to moisture
  • the first sheet 20 further includes a fifth layer 100 formed from aluminum foil having a third resistance to moisture greater than the first and second resistances. In this manner, the moisture vapor transmission rate (MVTR) of first sheet 20 is improved.
  • MVTR moisture vapor transmission rate
  • a sixth layer 106 is bonded to the second sheet 26 in a manner similar to the fifth layer 100 of the first sheet 20.
  • Four or more sheets can be laminated to each sheet.
  • Figs. 6a and 6b show construction details of the inlet/outlet ports 110, 130 shown in Fig.
  • Fig. 6a is a plan view of the warming cassette 200 showing a cross- section A-A through a first port 110.
  • the port 110 is operatively in fluid communication with the fluid channel 70 to permit the fluids to flow through the fluid container 10.
  • first port 110 typically includes a fitment or insert 111.
  • the insert 111 is substantially a cylindrical structure having proximal and distal ends 112 and 114, respectively.
  • the insert 111 is made from materials capable of bonding with, or to, the materials of the fluid container, as well as with IV tubing (see Fig. 7).
  • the insert 111 is formed by a coextrusion process, with a thermosealable material on its surface outside capable of bonding to the second and fourth layers, and a PVC-like material on its inside capable of bonding to the IV tubing.
  • the insert 111 comprises concentric circular layers and is made using a two-shot injection molded part.
  • the choice of insert material is made less critical by mechanically fitting the insert 11 1 to the container 10, with a barb-fitting being an example in this regard.
  • the insert 111 is mechanically interlocked between layers 24 and 30, or between layers 22 and 28.
  • Fig. 6b is a partial cross-sectional view along A-A of Fig. 6a.
  • the second and fourth layers 24 and 30 are shown with outside edges 80 and 82, respectively, which are also shown in Fig. 4a.
  • the insert 111 has an inner sleeve 116 of PVC material.
  • the outer sleeve 118 is made of EVA material. Regardless of the exact material, the outer sleeve 118 is typically joined to the fluid container 10 between said second and fourth layers 24 and 30 by thermo-bonding. Such a bond is especially effective when the second and fourth layers 24 and 30 are made from a film of a thermo-sealable material similar to the material of insert outer sleeve 118.
  • the distal end 114 of the insert 111 is connected to the fluid channel 70.
  • the proximal end 112 of the insert 111 extends beyond the second and fourth edges 80 and 82.
  • Fig. 7 illustrates the first port 110 of Figs. 6a and 6b connected with IV tubing.
  • a first tube 120 typically of PVC material, has a distal end 122 and an outer diameter 124.
  • the outer diameter 124 is joined to the inner sleeve 116, which is also a PVC material.
  • the tube 120 and inner sleeve 116 are joined by solvent bonding.
  • the fluid container 10 includes the first port 110 which may serve as a fluid inlet port, and further includes a second port 130 in communication with the fluid channel 70 to permit the outflow of fluid from the fluid container 10.
  • the second port 130 is connected to a second tube (not shown).
  • the fluid container 10 may have just a single port to dispense fluids.
  • Fig. 8 is a flowchart illustrating a method for forming a fluid container for use in a warming cassette. Initially, Step 202 forms a first sheet including at least a first and second layer. Step 204 forms a second sheet including at least a third and fourth layer. Typically, the layers are flexible films.
  • Step 202 joins the first and second layers together, while Step 204 joins the third and a fourth layers together.
  • Step 206 joins the first and second sheets with a seal acting between the second and fourth layers to form a fluid container between the first and second sheets.
  • Step 206 includes selectively joining the first and second sheets to form a se ⁇ entine pattern fluid channel.
  • Step 208 yields a product in the form of a fluid container having two multilayer sheets, in which a first plurality of layers (the first and third layers) add structural integrity to the fluid container.
  • Step 206 includes joining the second and fourth layers by thermo- bonding.
  • Steps 202 and 204 form first and third layers from a first material having a first melting point.
  • the second and fourth layers are formed from a second material having a second melting point lower than the first melting point.
  • Step 206 includes applying heat to the first and third layers to join the second and fourth layers by thermo-bonding.
  • Step 202 also includes extrusion coating the second layer on the first layer
  • Step 204 also includes extrusion coating the fourth layer on the third layer.
  • Steps 202 and 204 include selecting the second material from the group of materials consisting of polyolefin, polyethylene, polypropylene, polyvinyl chloride (PVC), polyurethane, and ethyl vinyl acetate (EVA) co- polymer.
  • Steps 202 and 204 include selecting the first material from the group of materials consisting of polyester, polyamide, polyethylene glycol terephthalate, metal foils, and ionomer resins.
  • Step 202 includes laminating the first and second layers by adhesive bonding
  • Step 204 includes laminating the third and fourth layers by adhesive bonding.
  • Step 202 laminates the first and second layers by solvent bonding
  • Step 204 laminates the third and fourth layers by solvent bonding.
  • Steps 202 and 204 include the first and third layers being formed from a first material having a first hardness, and include the second and fourth layers being formed from a second material having a second hardness less than the first hardness.
  • Steps 202 and 204 include forming the first and third layers from a first material having a first coefficient of friction, and forming the second and fourth layers from a second material having a second coefficient of friction greater than the first coefficient of friction.
  • Steps 202 and 204 include forming the first and third layers from a first material having a first susceptibility to stretching, and forming the second and fourth layers from a second material having a second susceptibility to stretching greater than the first susceptibility.
  • Step 200 provides a fifth layer of film, having markings for the pu ⁇ ose of identification, and Step 202 includes joining the fifth layer to the first sheet.
  • Step 202 includes forming the first layer from a first material having a first moisture vapor transmission rate (MVTR), forming the second layer from a second material having a second MVTR, and forming the fifth layer from aluminum foil which has a third MVTR lower than the first and second MVTR.
  • Step 200 provides at least a first fluid port insert having proximal and distal ends, an inner sleeve of PVC material, and an outer sleeve.
  • the insert outer sleeve is made from an EVA material.
  • Step 206 includes joining the insert's outer sleeve between the second and fourth layers by thermo-bonding.
  • the insert's distal end is connected to the fluid channel and the insert's proximal end extends past the second and fourth layers' outside edges.
  • Step 200 having proximal and distal ends, an inner sleeve of PVC material.
  • Step 206 includes joining the outer sleeve between the second and fourth layers by thermo-bonding, with the insert's distal end connected to the fluid channel and the insert's proximal end extending past the second and fourth layers' outside edges.
  • Step 202 includes the first and second layers having substantially the same size, an equal surface area and shape.
  • the first and second layers are joined so that the outside edges of the first and second layers substantially align. That is, the interfacing surfaces of the first and second layers are not exposed.
  • Step 204 includes the third and fourth layers having substantially the same size, an equal surface area and shape.
  • the third and fourth layers are joined so that the outside edges of the third and fourth layers substantially align. That is, the interfacing surfaces of the third and fourth layers are not exposed.
  • Step 206 includes joining the first and second sheets so that the outside edges of the first, second, third, and fourth layers align, as defined above.
  • the layers need not be the same size, with Step 202 forms the first layer be a larger size, as measured in area, than the second layer.
  • the first layer outside edge extends, at least partially, past the second layer outside edge, and Step 204 including that the third layer be a larger size than the fourth layer, with the third layer outside edge extending past the fourth layer outside edge.
  • Step 206 includes joining the first and second sheets so that surfaces of the first and third layers are exposed.
  • Step 202 includes the second layer being a larger size, as measured in area, than the first layer.
  • the second layer outside edge extends, at least partially, past the first layer outside edge
  • Step 204 includes that the fourth layer is a larger size than the third layer, with the fourth layer outside edge extending past the third layer outside edge.
  • Step 206 includes joining the first and second sheets so that surfaces of the second and fourth layers are exposed.
  • Step 202 includes the first layer being a larger size, as measured in area, than the second layer.
  • the first layer outside edge extends, at least partially, past the second layer outside edge.
  • Step 204 includes the third and fourth layer being smaller in size that the first layer.
  • Step 206 includes joining the first and second sheets so that surfaces of the first layer are exposed.
  • Step 202 includes the second layer being a larger size, as measured in area, than the first layer.
  • the second layer outside edge extends, at least partially, past the first layer outside edge.
  • Step 204 includes the third and fourth layer being smaller in size that the second layer.
  • Step 206 includes joining the first and second sheets so that surfaces of the second layer are exposed.
  • a fluid container, and method for forming a fluid container for use in a parenteral warming cassette have been described in terms of a number of embodiments. This description is meant to illustrate the invention. Other variations and embodiments of the invention will occur to those skilled in the art.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention se rapporte à un contenant pour fluide conçu pour être utilisé dans une cassette de chauffage d'un système de chauffage de fluide, qui comporte deux feuilles multicouches assemblées de manière à définir entre elles un trajet pour le fluide. Chaque feuille du contenant pour fluide comprend une couche structurale externe et une couche de collage interne. Les couches structurales possèdent un faible coefficient de friction, de sorte que la cassette glisse facilement dans l'unité de chauffage. Ces couches structurales sont assez fines pour permettre un transfert efficace de la chaleur, et cependant assez résistantes pour conférer une intégrité structurale au contenant pour fluide. Les couches internes possèdent des caractéristiques d'aptitude au thermoscellage qui permettent la formation du canal pour fluide par thermoscellage à températures relativement basses.
PCT/US2000/002630 1999-10-08 2000-02-02 Solution parenterale tolerant la pression et contenant pour le sang destine a une cassette de chauffage Ceased WO2001026719A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU27506/00A AU2750600A (en) 1999-10-08 2000-02-02 Pressure tolerant parenteral fluid and blood container for warming cassette

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41555899A 1999-10-08 1999-10-08
US09/415,558 1999-10-08

Publications (1)

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WO2001026719A1 true WO2001026719A1 (fr) 2001-04-19

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Cited By (18)

* Cited by examiner, † Cited by third party
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US7316666B1 (en) 2004-04-12 2008-01-08 Arizant Healthcare Inc. Fluid warming cassette with rails and a stiffening member
US7720362B2 (en) 2007-04-24 2010-05-18 Arizant Healthcare Inc. Heat exchanger for high flow rate infusion
US7853131B2 (en) 1999-10-08 2010-12-14 Arizant Healthcare Inc. Intravenous fluid warming cassette
GB2491623A (en) * 2011-06-09 2012-12-12 Alberto Martinez Albalat Multilayer fluid heat exchanger comprising plastic and metal layers
US8620149B2 (en) 2003-03-25 2013-12-31 Arizant Healthcare Inc. Fluid warming cassette and system capable of operation under negative pressure
WO2015122937A1 (fr) * 2014-02-14 2015-08-20 Zoll Circulation, Inc. Cassette à fluide dotée de membranes polymères et de tubes d'entrée et sortie d'un seul tenant pour un système d'échange thermique de patient
WO2015122936A1 (fr) * 2014-02-14 2015-08-20 Zoll Circulation, Inc. Cassette de fluide ayant des membranes polymères tendues pour un système d'échange de chaleur pour patient
US9474644B2 (en) 2014-02-07 2016-10-25 Zoll Circulation, Inc. Heat exchange system for patient temperature control with multiple coolant chambers for multiple heat exchange modalities
US9784263B2 (en) 2014-11-06 2017-10-10 Zoll Circulation, Inc. Heat exchange system for patient temperature control with easy loading high performance peristaltic pump
US10022265B2 (en) 2015-04-01 2018-07-17 Zoll Circulation, Inc. Working fluid cassette with hinged plenum or enclosure for interfacing heat exchanger with intravascular temperature management catheter
US10500088B2 (en) 2014-02-14 2019-12-10 Zoll Circulation, Inc. Patient heat exchange system with two and only two fluid loops
US10537465B2 (en) 2015-03-31 2020-01-21 Zoll Circulation, Inc. Cold plate design in heat exchanger for intravascular temperature management catheter and/or heat exchange pad
US10921021B2 (en) 2016-03-23 2021-02-16 Wwt Technischer Geraetebau Gmbh Modular blood warmer
US11185440B2 (en) 2017-02-02 2021-11-30 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
US11213423B2 (en) 2015-03-31 2022-01-04 Zoll Circulation, Inc. Proximal mounting of temperature sensor in intravascular temperature management catheter
US11359620B2 (en) 2015-04-01 2022-06-14 Zoll Circulation, Inc. Heat exchange system for patient temperature control with easy loading high performance peristaltic pump
US11571332B2 (en) 2012-09-28 2023-02-07 Zoll Circulation, Inc. Intravascular heat exchange catheter and system with RFID coupling
US11951035B2 (en) 2017-02-02 2024-04-09 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control

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EP0119469A2 (fr) * 1983-02-17 1984-09-26 Fresenius AG Sac pour le stockage du sang
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Cited By (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7853131B2 (en) 1999-10-08 2010-12-14 Arizant Healthcare Inc. Intravenous fluid warming cassette
US8620149B2 (en) 2003-03-25 2013-12-31 Arizant Healthcare Inc. Fluid warming cassette and system capable of operation under negative pressure
US7316666B1 (en) 2004-04-12 2008-01-08 Arizant Healthcare Inc. Fluid warming cassette with rails and a stiffening member
US7720362B2 (en) 2007-04-24 2010-05-18 Arizant Healthcare Inc. Heat exchanger for high flow rate infusion
US7803217B2 (en) 2007-04-24 2010-09-28 Arizant Healthcare, Inc. Bubble trap for high flow rate infusion
US7927302B2 (en) 2007-04-24 2011-04-19 Arizant Healthcare Inc. High flow rate infusion unit and heat exchanger
US7983540B2 (en) 2007-04-24 2011-07-19 Arizant Healthcare Inc. Heat exchanger for high flow rate infusion
US8180206B2 (en) 2007-04-24 2012-05-15 Arizant Healthcare Inc. High flow rate infusion with extraction assist
US8241409B2 (en) 2007-04-24 2012-08-14 Arizant Healthcare Inc. Bubble trap for high flow rate infusion
US8385731B2 (en) 2007-04-24 2013-02-26 Arizant Healthcare Inc. Heat exchanger for high flow rate infusion
GB2491623A (en) * 2011-06-09 2012-12-12 Alberto Martinez Albalat Multilayer fluid heat exchanger comprising plastic and metal layers
CN103608059A (zh) * 2011-06-09 2014-02-26 摄尔修斯医疗有限公司 液体加温或冷却系统
JP2014523287A (ja) * 2011-06-09 2014-09-11 セルシアス メディカル エス． エル． 流体加熱又は冷却システム
US11571332B2 (en) 2012-09-28 2023-02-07 Zoll Circulation, Inc. Intravascular heat exchange catheter and system with RFID coupling
US10828189B2 (en) 2014-02-07 2020-11-10 Zoll Circulation Inc. Heat exchange system for patient temperature control with multiple coolant chambers for multiple heat exchange modalities
US9474644B2 (en) 2014-02-07 2016-10-25 Zoll Circulation, Inc. Heat exchange system for patient temperature control with multiple coolant chambers for multiple heat exchange modalities
JP2019010526A (ja) * 2014-02-14 2019-01-24 ゾール サーキュレイション インコーポレイテッドＺＯＬＬ Ｃｉｒｃｕｌａｔｉｏｎ，Ｉｎｃ． 患者熱交換システム用の高分子膜および統合された入口および出口管を有する流体カセット
WO2015122937A1 (fr) * 2014-02-14 2015-08-20 Zoll Circulation, Inc. Cassette à fluide dotée de membranes polymères et de tubes d'entrée et sortie d'un seul tenant pour un système d'échange thermique de patient
US12427055B2 (en) 2014-02-14 2025-09-30 Zoll Circulation, Inc. Patient heat exchange system with two and only two fluid loops
CN106068112A (zh) * 2014-02-14 2016-11-02 佐尔循环公司 用于患者换热系统的具有高分子膜以及一体式进口和出口管的流体闸盒
CN106068113A (zh) * 2014-02-14 2016-11-02 佐尔循环公司 用于患者换热系统的具有张紧的高分子膜的流体闸盒
EP3520748A1 (fr) * 2014-02-14 2019-08-07 ZOLL Circulation, Inc. Cassette à fluide dotée de membranes polymères et de tubes d'entrée et sortie d'un seul tenant pour un système d'échange thermique de patient
JP7005103B2 (ja) 2014-02-14 2022-01-21 ゾール サーキュレイション インコーポレイテッド 患者熱交換システム用の高分子膜および統合された入口および出口管を有する流体カセット
US10500088B2 (en) 2014-02-14 2019-12-10 Zoll Circulation, Inc. Patient heat exchange system with two and only two fluid loops
US11033424B2 (en) 2014-02-14 2021-06-15 Zoll Circulation, Inc. Fluid cassette with tensioned polymeric membranes for patient heat exchange system
US10792185B2 (en) 2014-02-14 2020-10-06 Zoll Circulation, Inc. Fluid cassette with polymeric membranes and integral inlet and outlet tubes for patient heat exchange system
WO2015122936A1 (fr) * 2014-02-14 2015-08-20 Zoll Circulation, Inc. Cassette de fluide ayant des membranes polymères tendues pour un système d'échange de chaleur pour patient
US11353016B2 (en) 2014-11-06 2022-06-07 Zoll Circulation, Inc. Heat exchange system for patient temperature control with easy loading high performance peristaltic pump
US9784263B2 (en) 2014-11-06 2017-10-10 Zoll Circulation, Inc. Heat exchange system for patient temperature control with easy loading high performance peristaltic pump
US10502200B2 (en) 2014-11-06 2019-12-10 Zoll Circulation, Inc. Heat exchanges system for patient temperature control with easy loading high performance peristaltic pump
US10537465B2 (en) 2015-03-31 2020-01-21 Zoll Circulation, Inc. Cold plate design in heat exchanger for intravascular temperature management catheter and/or heat exchange pad
US11992434B2 (en) 2015-03-31 2024-05-28 Zoll Circulation, Inc. Cold plate design in heat exchanger for intravascular temperature management catheter and/or heat exchange pad
US11213423B2 (en) 2015-03-31 2022-01-04 Zoll Circulation, Inc. Proximal mounting of temperature sensor in intravascular temperature management catheter
US11759354B2 (en) 2015-04-01 2023-09-19 Zoll Circulation, Inc. Working fluid cassette with hinged plenum or enclosure for interfacing heat exchanger with intravascular temperature management catheter
US11359620B2 (en) 2015-04-01 2022-06-14 Zoll Circulation, Inc. Heat exchange system for patient temperature control with easy loading high performance peristaltic pump
US10022265B2 (en) 2015-04-01 2018-07-17 Zoll Circulation, Inc. Working fluid cassette with hinged plenum or enclosure for interfacing heat exchanger with intravascular temperature management catheter
US12305631B2 (en) 2015-04-01 2025-05-20 Zoll Circulation, Inc. Heat exchange system for patient temperature control with easy loading high performance peristaltic pump
US10921021B2 (en) 2016-03-23 2021-02-16 Wwt Technischer Geraetebau Gmbh Modular blood warmer
DE102017204776B4 (de) 2016-03-23 2021-09-23 Stihler Electronic Gmbh Modularer Blutwärmer und Verfahren
US11883323B2 (en) 2017-02-02 2024-01-30 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
US11951035B2 (en) 2017-02-02 2024-04-09 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control
US11185440B2 (en) 2017-02-02 2021-11-30 Zoll Circulation, Inc. Devices, systems and methods for endovascular temperature control

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