Flexible container with flexible port and method of making the same

Flexibility A flexible container with a flexible front sheet that is sealed along the perimeter to the flexible rear sheet provides a flexible mounting flange that is attached between the front and rear seats. Along with a detailed description of a flexible container having a container port provided, it is generally described herein.

Flexible containers are widely used for filling nutrient infusions, diluents, medicines, IVs and the like. Generally speaking, such a flexible container includes attaching a first flexible sheet to a second flexible sheet along the outer circumference, filling the container, discharging from the container, and /. Alternatively, it is manufactured by inserting one or more ports between the two sheets for replenishment or addition of other fluids to the container. The sheet used to make the flexible container may be made from a single-layer flexible thermoplastic sheet or a multi-layer flexible thermoplastic sheet. One or more ports generally include a set port for spike entry and exit of an infusion set, or an additive port for use with a needle. The flexible container may include a peelable seal to form a multi-part container.

A common feature of prior art ports used with prior art flexible containers is a port with a rigid mounting flange or inflexible mounting flange with an undulating shape. An undulating heat die with an undulating shape that fits as a mounting flange in order to heat fuse these prior art mounting flanges to the front and rear seats to constitute a conventional flexible container. (heat die) is used. This undulating heat die heats the mounting flange and fuses it to the sheet to form a flexible vessel. Occasionally, misalignment between the undulating heat die and the undulating mounting flange can result in inaccurate heat fusion of the port to the seat. As is readily apparent, inaccurate heat fusion will result in defective containers. In addition to this, the heat die needs to be aligned with the mounting flange, which adversely affects production due to the alignment requirements.

<p> Therefore, there is a need for containers with easy-to-install ports that are less dependent on alignment requirements.</p>

<p> The present invention, in particular, examines and ameliorate the aforementioned defects associated with prior art assemblies. More specifically, the present invention relates to a flexible front sheet and a flexible rear sheet attached to each other along at least one edge, and the flexible front sheet and the flexible rear sheet. A container port with a nozzle integrally molded with a mounting flange located between and, the mounting flanges of which are mounted to each other along at least one edge, with an inner surface and an outer surface. A first mounting flange layer comprising a first mounting flange layer and a second mounting flange layer comprising an inner surface and an outer surface, and at least one heat bar located between the flexible front sheet and the flexible rear sheet. heat A first having two inner surfaces of a first and second mounting flange layer that are at least partially in contact with each other when heat fused to the flexible front sheet and the flexible rear sheet by bar). A flexible vessel with a shape configuration and a second shape configuration with two inner surfaces that are spaced apart from each other at a distance from at least one edge when the at least one heat bar is removed. May be realized by providing.</p><p> In another aspect of the invention, the flexible front sheet and the flexible rear sheet, which are attached to each other along at least a part of a common outer circumference, and the flexible front sheet and the flexible rear sheet. A flexible container including a container port with a nozzle integrally molded with the flexible mounting flange attached to the flexible flange, the flexible flange having an inner surface and an outer surface. It comprises a first flange layer with an inner surface and an outer surface attached to the flange layer, these two flange layers having a first opening and a larger second opening in fluid communication with the nozzle. And when the flexible mounting flange is compressed between the flexible front sheet and the flexible rear sheet by the heat bar, at least a portion of the inner surface of the first flange layer is the second. A flexible container is provided that contacts at least a portion of the inner surface of the flange layer of the.</p><p> In yet another aspect of the invention, the flexible front sheet and the flexible rear sheet, which are attached to each other along a common outer circumference, and the flexible front sheet and the flexible rear sheet are attached to each other. A container port with a nozzle integrally molded with the flexible mounting flange and a flexible front flange sheet mounted on the flexible rear flange sheet along the two common edges. Extends from each of the two common edges of the flexible mounting flange, with a flexible mounting flange and a first thickness that tapers away from its common edge to a second thickness. When the fin and the flexible mounting flange are attached to the flexible front and rear seats by a heat bar, they make at least some temporary contact with the inner surface of the flexible rear flange layer. Flexibility A flexible container with an inner surface of a front flange layer is provided.</p><p> Further, in another aspect of the present invention, the flexible front sheet and the flexible rear sheet, which are attached to each other along a common outer circumference, and the flexible front sheet and the flexible rear sheet. A container port with a nozzle integrally molded with the attached flexible mounting flange and a flexible front flange sheet attached to the flexible rear flange sheet along two common edges. The flexible mounting flange provided and the flexible mounting flange are at least partially temporarily attached to the inner surface of the flexible rear flange layer when the flexible mounting flange is attached to the flexible front and rear seats by a heat bar. Flexibility to contact Flexibility to include an inner surface of the anterior flange layer and a terminal port provided with a piercing membrane located within the inner cavity and attached to the vessel port. A container is provided.</p><p> The true value of these features and advantages of the present invention and other features and advantages will be understood when they are better understood with reference to the detailed description, claims and accompanying drawings. ..</p>

<figref num="1">FIG. 1 is a semi-rough side view of a container realized according to aspects of the present invention.</figref><figref num="2">FIG. 2 is a semi-schematic side view of a container port that includes a flexible mounting flange and can be used with the container of FIG. 1 realized in accordance with aspects of the invention.</figref><figref num="3">FIG. 3 is a partial cross-sectional side view of a multilayer flexible container sheet realized according to various aspects of the present invention.</figref><figref num="4">FIG. 4 is a semi-rough end view of the container port of FIG. 2 taken along line AA.</figref><figref num="4A">FIG. 4A is a semi-rough end view of the container port of FIG. 4 with a flattened mounting flange.</figref><figref num="5">FIG. 5 is a semi-rough cross-sectional side view of the port of FIG. 2 taken along line BB.</figref><figref num="6">FIG. 6 is a semi-schematic side view of a terminal port that can be used with the container port of FIG. 2 realized in accordance with aspects of the invention.</figref><figref num="7">FIG. 7 is a semi-rough end view of the end port of FIG. 6 taken along line CC.</figref><figref num="8">FIG. 8 is a semi-rough cross-sectional side view of the port of FIG. 7 taken along line DD.</figref><figref num="9">FIG. 9 is a semi-schematic side view of an alternative end port that can be used with the container port of FIG. 2 realized in accordance with aspects of the invention.</figref><figref num="10">FIG. 10 is a semi-rough cross-sectional side view of the port of FIG. 9 taken along line EE.</figref><figref num="11">FIG. 11 is a semi-schematic side view of an alternative end port that can be used with the container port of FIG. 2 realized in accordance with aspects of the invention.</figref><figref num="12">FIG. 12 is a semi-rough cross-sectional side view of the port of FIG. 11 taken along line FF.</figref><figref num="13">FIG. 13 is a semi-schematic of the terminal port of FIG. 11 attached to the container port of FIG. 2, which is an exemplary usable port combination with the container of FIG. 1 realized according to aspects of the invention. Partial perspective cross-sectional side view.</figref><figref num="14">FIG. 14 is another exemplary usable port combination with the vessel of FIG. 1 realized in accordance with aspects of the invention, a semi-outline of the alternative end port attached to the vessel port of FIG. Partial perspective cross-sectional side view.</figref><figref num="15">FIG. 15 is another exemplary usable port combination with the container of FIG. 1 realized in accordance with aspects of the invention, half of the terminal port of FIG. 9 attached to the container port of FIG. It is a schematic partial perspective cross-sectional side view.</figref><figref num="16">FIG. 16 shows the terminal port of FIG. 6 attached to the vessel port of FIG. 2, which is yet another exemplary usable port combination with the vessel of FIG. 1 realized in accordance with aspects of the invention. It is a semi-schematic partial perspective cross-sectional side view.</figref><figref num="17">FIG. 17 is a semi-schematic partial perspective cross-sectional side view of a two-port assembly attached to two end ports realized according to aspects of the present invention.</figref><figref num="18">FIG. 18 is a semi-rough partial perspective cross-sectional side view of an alternative combination container port realized according to aspects of the present invention.</figref>

The detailed description described below in connection with the accompanying drawings is intended to be a description of a currently preferred embodiment of a flexible container having a flexibility port realized by the practice of the present invention. , And is not intended to represent the only form in which the invention may be constructed or used. This description describes the features and steps for assembling and using the flexible container of the present invention in connection with the illustrated embodiment. However, it should be understood that the same or equivalent function and structure may be realized by different embodiments that are also intended to be within the scope of the ideas and scope of the invention. .. Moreover, it is intended that the same element number indicates the same or similar element or feature as shown elsewhere herein.

Now, with reference to FIG. 1, this figure shows an exemplary flexible container 10 realized in accordance with aspects of the invention. The flexible container 10 is sealed between the first sheet 16 and the second sheet 18 (inserted below the first sheet) by the outer peripheral seal 20, the first port. It has 12 and a second port 14. The first port 12 and the second port 14 may function as a filling port, a drain port, or an additive port. The perimeter seal 20 defines a volumetric enclosure that varies in volume, especially depending on the size of the first and second sheets 16, 18 and generally has a seal width of about 2 mm to about 6 mm, and , 3 mm is more preferred. The exemplary volumes defined by the first and second sheets 16 and 18 include from about 100 ml to about 3000 ml, and other volumes are envisioned. This vessel is further variable by using stretchable first and second sheets that can be stretched from a first surface area to a second larger surface area to produce a larger volume capacity. Volume may be realized. An exemplary stretchable container is disclosed in US Pat. No. 5,910,138, the contents of which are specifically incorporated herein by reference.

An end device overlying ports 12 and 14 is shown, which end device includes an end port 22 overlaid by a selectable end cap 19. An additional end cap 19 is described in more detail below, but a set port cap 24 and an additive port cap 26 are attached to the first port 12 and the second port 14, respectively. It is shown as being overlaid on the terminal port 22. In one exemplary embodiment, container 10 is constructed in accordance with aspects of the invention disclosed in US Pat. No. 4,803,102 to Raniere et al., The content of which patent is specifically incorporated herein by reference. There is.

Container 10 may include one or more ports attached along one or more edges of the container 10 and, instead of two separate sheets, a single sheet. May be made by folding and sealing the overlapping edges of the outer circumference of the single sheet to form a container. Alternatively, as an alternative, create a form with multiple compartments similar to the containers disclosed in U.S. Pat. Nos. 5,910,138, 5,928,213, 5,944,709, 6,165,161, and 6,203,535. The contents of these patents are specifically incorporated herein by reference. In addition, multiple compartments can be divided so that the contents are mixed before exiting one or more drain ports as a mixture, or, as an alternative, of the stored compartments. Each can be divided into separate fill / drain ports and fluid communication.

Optionally, a hanging flap 28 may be included between the top outer peripheral seal 21 and the inner outer peripheral seal 30 near the upper end 23 of the container. In one exemplary embodiment, the inner perimeter seal 30 comprises a bow-shaped seal having a bending radius of about 100 mm to about 300 mm and can vary depending on the size of the container. The hanging flap 28 includes one or two overlapping hanging holes 32 for hanging the container 10 on a pin or hook. The hanging holes may also be fragile or fragile parts of the hanging flap 28 for later removal by the user. In another exemplary embodiment, the hanging flap 28 may be separated from the top outer peripheral seal 21 such that the flap swivels or anchors from the bow-shaped inner outer peripheral seal 30.

One or more drain seals 34 may be incorporated along the lower end 36 of the container 10. The drain seal may include a pair of generally bow-shaped heat seals 34 formed in the corners 37 of the lower end 36 of the vessel. The drain seal 34 directs the fluid stored in the vessel to the first and second ports 12, 14 so that it exits at least one of the first and second ports 12, 14. To facilitate or direct the flow. In one exemplary embodiment, the drain seal has a bending radius of about 20 mm to about 150 mm. However, other bending radii may be adopted, depending on the size of the container.

Next, with reference to FIG. 2, this figure shows a semi-rough side view of a port implemented according to aspects of the invention, the first of which is shown in FIG. It may be port 12 or a second port 14. For ease of reference, only port 12 will be discussed, but it is understood that the same description applies to port 14.

Port 12, sometimes referred to as the vessel port, includes a flange 38, a tapered or contracted neck 40, a generally cylindrical nozzle 42, a mounting flange 44 that resembles a diffuser or funnel, and multiple fins or ribs. Including 46 and. The cylindrical nozzle 42 has fluid communication with the cavity defined by the mounting flange 44, and the mounting flange 44 is relative to the first flange opening near the base 50 at the boundary with the nozzle 42. It has a small second opening. Each of the fins or ribs 46 comprises a first fin portion 48 near the base 50 of the mounting flange 44 and a second smaller fin portion 52 closer to the boundary between the nozzle 42 and the mounting flange 44. Alternatively, instead, the first and second fin portions 48, 52 can mesh or have a uniform shape so that the fractionation line does not exist between the two fins. The optional protrusion 43 is formed radially on the outer peripheral portion of the flange 38 and extends radially in a length of about 1 mm to about 2.5 mm, preferably 1.3 mm. When the protrusion 43 is included, the protrusion 43 facilitates injection of molten plastic during the molding process.

In one exemplary embodiment, the vessel port 12 is integrated from a blend of polypropylene-ethylene random copolymer with a wt-wt ratio of about 95: 5 to about 30:70 and styrene ethylene-butylene styrene thermoplastic elastomer (SEBS). It is molded. In one preferred embodiment, a ratio of polypropylene-ethylene random copolymer to SEBS of 80:20 wt-wt ratio is blended to form port 12 of this exemplary embodiment. SEBS is commercially available from the KRATON Polymers Company under the trade name "KRATON" with the product name "G1652". Polypropylene-polyethylene copolymers are Atofina Petrochemicals It is available from Company (Houston, Texas) and has the product name "Z9450". In practice, this blend is aggregated with Z9450 copolymer resin pellets in a high shear mixer at an 80:20 wt-wt ratio or any other desired ratio depending on the desired finished product. It is made by mixing with G1652 thermoplastic elastomer pellets and melting and repelleting this mixture. The port 12 is then formed from the blended pellets in an industrial injection molding process. This formed port 12 collapses the mounting flange when heat-sealed to the first and second sheets 16 and 18 using a flat heat bar, but after the heat-sealing process as described below. It has a semi-rigid softness that allows the mounting flange to have sufficient elasticity to recover most of the structure without recovering the entire structure.

With reference to FIG. 1 again, the mounting flanges 44 of the container ports 12 and 14 may be secured to the first and second sheets 16 and 18, and more specifically, the inner surfaces of the first and second sheets. May be fixed to. In one exemplary embodiment, the first and second sheets 16, 18 are made from a multilayer film containing materials that are compatible with the port material. With reference to FIG. 3, this figure shows a multilayer film. The multilayer film 16 or 18 may include an outer layer 53, an intermediate layer 54, and an inner layer 56. As disclosed in US Pat. No. 4,803,102 incorporated above, the composition of the inner layer 56 comprises polypropylene-polyethylene copolymer and SEBS and is similar to the composition of container ports 12, 14.

The outer layer 53 may include a polyether blockamide copolymer (PEBA) or an abuse resistant material containing an ester group called EGM. One exemplary EGM is copolyester, available from the Eastman Kodak Company (Rochester, NY) under the product name "Eastman PCCE 9967". PCCE 9967 is a glycol-modified cyclohexane dimethano-cyclohexane-dicarboxylate. The outer layer 53 can further contain polycarbonate (PC). The intermediate layer 54 may vary depending on whether the outer layer 53 is made from a blend of EGM or PEBA. If the outer layer 53 is EGM, a particularly suitable material for use as the intermediate layer 54 is SEBS. If the outer layer 53 is made from a blend of PEBA, a suitable material for use as the intermediate layer 54 is an Admer commercially available from Mitsui Petrochemical. Carboxy-modified polypropylenes such as QF-500, QF-550, and QF-551.

Generally speaking, the film thickness of the multilayer films 16 and 18 can be in the range of about 1.5 mils to about 20 mils, and preferably in the range of about 6 mils to about 12 mils. In this preferred group of films, the preferred ratio of these layers to the total thickness of the three-layer composite is about 60% to about 85% inner layer 56 and about 5% to about 30% outer layer 53. The middle layer 54 is about 7% to about 15%. More preferred films are about 77% layer 56 as a blend of PPE and SEBS, about 13% layer 53 as copolyester, and about 10% layer 54 as SEBS.

The container 10 of FIG. 1 is made by first forming an outer peripheral seal 20, a drain seal 34, an inner outer peripheral seal 30, and a hanging flap 28, except for the outer peripheral seal at the edge of the lower end 36. You can. This container places the inner layers 56 (Fig. 3) of the first and second sheets 16 and 18 in the opposite shape configuration, followed by a temperature above about 250 ° F and about 90 psi. It is preferably formed by using one or more suitable heat bars under pressure for at least 3 seconds. Mounting flanges 44 at ports 12 and 14 are inserted between the inner layers 56 of the first and second seats 16 and 18, and then one or more long enough flat heat bars attach the mounting flanges. It is used to fuse to these sheets. Alternatively, instead of attaching the mounting flanges 44 from each port at the same time, the mounting flanges 44 may be fused separately or sequentially.

In one exemplary embodiment, a heat bar with coated rubber sulfide is used to fuse the mounting flanges 44 of the container ports 12, 14 to the first and second sheets 16, 18. Heat bars with vulcanized rubber are commercially available from United Silicone (Lancaster, NY). This vulcanized rubber is a silicone rubber compound.

Next, with reference to FIG. 4, this figure shows a semi-rough bottom view of port 12 of FIG. 2, taken at line AA. When port 12 is placed between two seats and fused by a flat heat bar, in this fused shape configuration, the tip 58 of the first fin portion 48 of each fin 46 and the seats 16, 18 and Defines the two channels, one on each of the two sides of each fin. When the mounting flanges 44 are sealed to the first and second sheets, respectively, so that the liquid contained in the container 10 cannot leak through the flow path 60 (FIG. 1), respectively. It is preferable that the flow paths of the above are sealed or fused (ie, have no gaps or holes). In order to facilitate such fusion, in one exemplary embodiment, the port 12 is implemented in a form having a shape configuration that facilitates adhesion to the sheets 16 and 18.

Further referring to FIG. 4, the mounting flange 44 includes a horizontally elongated structure including a first mounting flange layer 62 joined to a second mounting flange layer 64 along each edge 66. In one exemplary embodiment, the edge 66 is a crease formed when the curved sides of the flange layers 62, 64 are integrally formed. The first and second mounting flange layers 62, 64 have a wall thickness of about 0.4 mm to about 1.5 mm, more preferably 0.7 mm. The measured mounting flange length from one mounting flange edge 66 to the other mounting flange edge 66 is approximately 29.5 mm, with a usable range of approximately 15 mm to approximately 50 mm. Each of the first fins 48 has a fin width of about 6 mm and has a draft or taper of about 10 ° to about 30 ° terminating in the form of a rounded tip, with an angle of 20 ° being more preferred. The fins have a thickness of about 1.30 mm when measured at their widest points, but smaller or larger fins are acceptable. Each of the first and second mounting flange layers 62, 64 is further at least the base portion of the mounting flange when the mounting flange is placed between the first and second sheets and sealed to it by a flat heat bar. Includes an inner surface 63 that contacts each other along a portion of 50. This is shown in Figure 4A with the flat heat bar omitted for clarity. After removing the flat heat bar, the first and second mounting flange layers are the inner surfaces of each flange layer that are spaced apart from each other, except for the edges where these mounting flange layers join together. Accompanied by restoring the shape or shape configuration of the mounting flange layer shown in FIG. This recovery is at least partially facilitated by the arched surfaces of the flange layers 62, 64.

As an advantage of the container realized by the aspects of the present invention, the removal of gas is facilitated by the flexible mounting flange 44. As is known to those of skill in the art, some of the solutions placed in the flexible container 10 may be sensitive to oxygen or other atmospheric gases. Therefore, these solutions usually have to be filled in a controlled environment. Among the steps required to handle oxygen or other atmospheric gas sensitive solutions, containers for storing these sensitive solutions are usually inert, such as nitrogen gases. Requires gas flushing or purification. The purified container is then sealed with fasteners near the container port and attached to a filling system for filling the container with sensitive solutions. This fastener is removed after the flattened container is in communication with the filling port of the filling system. After the filling step, the vessel is again sealed with fasteners near the vessel port before being transferred to the welding station for welding on the end port. After the welding stage, the fastener is removed.

The flexible mounting flange 44 realized by aspects of the invention facilitates the filling process with oxygen or other atmospheric gas sensitive solutions. In particular, this flexible mounting flange can be flattened and crushed so that residual gas remaining in the container is left before the container is filled with a solution sensitive to oxygen or other atmospheric gases. Fewer. This is also true when the filling nozzles 12, 14 are removed from the filling port after the filling step to allow the end 22 to be attached to the container nozzle. The ability to easily seal the filling port by flattening the mounting flange further enhances the control of leakage of the container.

FIG. 5 is a semi-rough cross-sectional side view of port 12 of FIG. 2 taken along line BB. In one exemplary embodiment, port 12 has an ID of 6.6 mm and a wall thickness of about 1.0 mm. Flange 38 includes a raised surface 68 having a diameter of about 17 mm and a flange thickness of about 2 mm, and a raised thickness of about 0.5 mm and a diameter of about 14.5 mm. The inner tapered surface 70 has an angle of about 25 to about 50 degrees from the vertical line, and more preferably about 39 degrees. In one exemplary embodiment, the diameter of the port and the length of the port are selected for realization, and then the taper angle is selected to admire the selected length and diameter. Will be done. Other dimensions may be realized without departing from the scope of the invention, and these other dimensions are the designer's choice, container size, specific end port, selected specific end cap, and use. Will depend on the IV dosing set.

FIG. 6 is a semi-rough side view of the terminal port 22 realized according to aspects of the present invention, which terminal port 22 is sometimes referred to as additive port 72. The additive port 72 has a first end 74 that includes a linear end with a generally cylindrical port portion 76 and a second end 78 that includes a fitting flange 80. The additive port 72 is attached to the flange 38 of the container port 12 by mounting, eg, by radiant heat process, by thermal fusion, by ultrasonic welding, by high frequency induction heating, or by hot plate welding, by conventional means. By heat-welding the second end 78, it can be used with the container port 12 of FIG.

An intermediate portion 82, including a tapered portion 84, connects the first end 74 to the second end 78. At the two intersections 86 where the tapered portion 84 intersects the first end 74 and the second portion 78, a curved transition is preferred, but instead this transition has a right angle intersection or a different curve. It may include a curved transition portion having. In one exemplary embodiment, the additive port 72 is made of the same material composition as the container port 12, the type of composition being within the range as described above for the container port 12, and the container sheet. It is acceptable. In an alternative embodiment, it is preferred that the material composition of the additive port 72, i.e. the blending percentage of each component, be selected to include a higher durometer or hardness than the container port 12. At the time of installation, a higher durometer enhances the attachment of the aluminum fasteners. In one exemplary embodiment, the first end 74 of the additive port 72 has an outer diameter of about 13 mm, the second end 78 has an outer diameter of about 15 mm, and the first. The measured additive port 72 length from one end to the second end is about 11 mm. However, depending on service, intended use, end cap, geographical destination of use, etc., this size may vary without departing from the ideas and scope of the invention.

Next, referring to FIG. 7, this figure shows an end view of FIG. 6 taken along line CC. In the plan view of FIG. 7, a portion of the fitting flange 80 is shown with a cylindrical end 88 of a generally cylindrical port portion 76, a plurality of ribs 90, and a central punctureable seal or membrane 92. .. The rib 90 extends radially inward from the inner surface 94 of the cylindrical port portion 76 defining the receiving chamber 96 and reduces the effective inner diameter of the cylindrical port portion by a corresponding amount as the thickness of the rib. Let me. Although four ribs 90 are shown, fewer or more ribs may be incorporated without departing from the scope of the invention.

A rubber bulkhead may be located within the receiving chamber 96 of the port. After being placed, the rubber bulkhead is centered by a rib in the end of the port. An aluminum crimp (Fig. 16) compresses the flange of the rubber bulkhead to achieve a seal. In this compressed shape configuration, the bottom of the rubber bulkhead is pressed against the central punctureable seal 92 to achieve sealing. In one exemplary embodiment, the cylindrical port portion 76 has an outer diameter of about 13 mm and an inner diameter of about 10 mm. Each of the ribs 90 extends approximately 1 mm inward in the radial direction. Rubber bulkheads are commercially available from several manufacturers, including West Pharmaceutical Services (Lionville, Pennsylvania).

FIG. 8 is a cross-sectional side view of the additive port 72 of FIG. 7 taken along line DD. As shown, the rib 90 extends approximately to the height of the receiving chamber 96. Alternatively, instead, the ribs may be removed by selecting a bulkhead having a diameter greater than the inner diameter of the port so that the inner surface of the port allows the rubber bulkhead to be centered. Good. The central punctureable seal 92 is integrally molded with the port 72 and has a non-uniform seal layer thickness, but uniformity is an acceptable option. In one exemplary embodiment, the central punctureable seal 92 has a raised central portion 98 with a thickness of about 0.7 mm and a shallow outer peripheral portion 100 with a thickness of about 0.3 mm. The raised portion 98 and the outer peripheral portion 100 are combined to facilitate injection molding. In an alternative embodiment, the raised central portion 98 includes a raised surface or domed surface extending from the outer peripheral portion 100 rather than the solid raised portion shown in FIG. Yet another alternative is that the inner cavity, defined by the generally cylindrical partial section 76, contains a flared portion near the cylindrical end 88 and has a non-uniform surface or special fit. It may include recesses and protrusions for accommodating rubber bulkheads that require a mating surface.

A diameter reduction portion 106 is included in the base 102 of the medial taper portion 104 to limit or define the effective area of the central punctureable seal 92. Therefore, the area of the central punctureable seal 92 may be increased or decreased depending on the area of the diameter reduction portion 106 to be realized. In one exemplary embodiment, the diameter reduction portion 106 has a diameter of about 5 mm. The inner tapered portion 104 has a draft of about 5 to about 35 degrees from the vertical line. As mentioned above, the diameter of the port and the length of the port are preferably selected first, and the taper angle is obtained as the dependent variable of the former. For example, the diameter at the second end 78 (FIG. 6) is chosen to match the flange 38 of the container port 12. The diameter at the reduced end 74 gives rise to a shoulder for the aluminum shell (FIG. 16). The length of the tapered portion is selected for automation.

FIG. 9 is a side view of an alternative terminal port 22 realized in accordance with aspects of the invention, which terminal port may be specifically referred to as additive port 108. This additive port 108 is configured for use with rubber bulkheads, such as sleeve stoppers made from West Pharmaceutical Services having part number "WS-191", for example. The additive port 108 includes a first end 74 comprising a first gripping flange 110 for gripping the sleeve stopper and a second fitting flange 80 for mating with the flange 38 of the container port 12. Includes end 78 and. In one exemplary embodiment, the gripping flange 110 of the additive port 108 has an intermediate portion 112, and the gripping flange 110 flares outward from this intermediate portion. The flared portion 114 of the grip flange 110 includes a curved portion having a bending radius of about 2.5 mm, a vertical portion 116, and an upper curved rim 118 having a bending radius of about 0.5 mm, the modification of which is also acceptable. ..

The fitting flange 80 extends from the flare portion 120. The boundary between the intermediate portion 112 and the flare portion 120 has a diameter of about 7.62 mm, and the boundary between the flare portion 120 and the flange has a diameter of about 11.5 mm. The length of the flare portion 120 is about 4.41 mm, and the fitting flange 80 has a flange thickness of about 2 mm. The overall height of additive port 108 is about 15 mm. The additive port 108 has the same material composition as the container port 12, but changes within the above range are acceptable. In one exemplary embodiment, the additive port 108 has a higher durometer or hardness than the container port 12 for handling during manufacturing and filling of the container. The additive port 108 is shown with a particular intermediate portion 112, a flare portion 120, and an arrangement of a punctureable seal 92 at the intersection of the intermediate portion and the flare portion. May have other shape configurations. For example, the tapered or flared portion 120 may have a steeper or shallower angle, and the punctureable seal 92 may be placed on a plane approximately coplanar with the flange 80, and intermediate. The portion may extend towards the length of port 108 between the flange 80 and the gripping flange 110 without the tapered portion 120.

FIG. 10 is a cross-sectional side view of the additive port 108 of FIG. Similar to the port of FIG. 8, the additive port 108 includes a central punctureable seal 92 that includes a raised central portion 98 and a shallow outer peripheral portion 100. This central punctureable seal 92 is located approximately near the transition between the intermediate portion 112 and the tapered portion 120, and this particular placement depends on the particular sleeve plug selected. ..

A tapered inner cavity with a tapered wall 122 is included to facilitate insertion of the sleeve plug. However, depending on the shape configuration of the sleeve plug, this inner cavity may include a linear inner cavity or other corresponding shape configuration.

FIG. 11 is a semi-rough side view of an alternative terminal port 22 implemented in accordance with aspects of the invention, which terminal port is sometimes referred to as a set port or infusion set port 124. .. The set port 124 includes a first end 126 having a right-angled finish and a second end 128 having a fitting flange 80. Between the first end 126 and the second end 128, the set port 124 includes a generally cylindrical portion 130 and a tapered portion 120. The location of the boundary between the cylindrical portion 130 and the tapered portion 120 roughly meets the requirements for accommodating an IV set closure puncture device according to ISO 8536-4 standard IV spike 6.4 for the IV dosing set. .. In one exemplary embodiment, the overall length of the filling port 124 is about 15 mm, the length of the generally cylindrical portion 130 is about 10 mm, and the outer diameter of the generally cylindrical portion is about 9.0 mm. .. For manufacturing, the generally cylindrical portion 130 may have a draft of about 1 degree to about 5 degrees.

A cross-sectional side view of port 24 in FIG. 11 taken along line FF is shown in FIG. As shown in this figure, a central punctureable seal 92 is included, which includes a raised central portion 98 and a shallow outer peripheral portion 100. As is readily apparent, a central punctureable seal 92 may be included instead of the raised central portion 98. The placement of the central punctureable seal 92 with respect to the inner diameter of the set port 124 and the length of the port may be tailored to the particular selected IV spike set to be used with the set port. An alternative embodiment may include a punctureable seal 92 without a protruding or raised central portion 98, or, in yet another alternative, the raised central portion 98 end with a mating flange 80. It may extend towards the second end 118 that it has. Yet another alternative is that the inner surface 125 of the set port 124 may include a rugged or wavy surface to improve grip on the spike or IV dosing set or to accommodate the rubber septum. ..

The set port 124 may be available for use with the container 10 of FIG. 1 by attaching the set port to the first container port 12 or the second container port 14. It is preferred that this set port be attachable to the first port 12 or the second port 14 by heat-sealing the mating flange 80 to the flange 38 of the first or second port. It is preferred that the first end 126 be sealed to maintain sterility. In one exemplary embodiment, the first end may be sealed with an inner seal. An exemplary inner seal and method of using this inner seal are assigned to Selig Sealing Products, Inc. (Oakbrook Terrace, Ill), US Pat. Nos. 5,702,015, 5,860,544, 5,915,577, Foil inner seal (foil) disclosed in No. 6,461,714 and its equivalents innerseal) is included. The contents of these patents are incorporated herein by reference. The other inner seal may include an aluminum foil material that is heat-bonded to the end of the first end 126 by conventional means.

Next, with reference to FIG. 13, this figure shows a partial perspective cross-sectional side view of the set port 124 of FIG. 11 attached to port 12 of FIG. For clarity, the container port 12 is shown with the first sheet 16 and the second sheet 18 removed. The mating flange 80 of the set port 124 is shown which has been heat-sealed to the flange 38 of the container port 12 by a radiant heat fusion or hot bar sealing process. This heat fusion step is preferably performed after the container 10 has been filled with, for example, an amino acid solution or a grape sugar solution through port 12.

The inner seal 132 is attached to the end of the first end 126 of the set port 124 by conventional means. For the contents of container 10, excess, the inner seal 132 of set port 124 was stripped and a puncture connector (not shown) was inserted, which in turn was then the container and IV dosing set (not shown). A central punctureable seal 92 is punctured to provide fluid communication with (not shown).

FIG. 14 is a partial perspective cross-sectional side view of an alternative end port 22 realized in accordance with aspects of the present invention. The end port 22 may be referred to as a dripless set port 134 and shares certain features with the set port described above. This dripless set port 134 includes an end that includes a flange 136 and an end that has a right-angled finish 138, which may include tapered rims or tapered edges on both the inner and outer edges. .. In one exemplary embodiment, the end with a right angle finish is attached to the flange 38 of the container port 12, and the end with the flange 136 is sealed by an inner seal 132. This attachment may be performed by a conventional radiant heat fusion process or an equivalent process.

In another exemplary embodiment, the rubber bulkhead 140 is used to reseal the dripless set port after the needle or spike connector has punctured the bulkhead 140 and the central punctureable seal 92 and subsequently removed. It is located in the upper cavity 142 of the dripless set port 134. The rubber bulkhead may be molded separately and then placed in the upper cavity of the dripless set port 134, or may be injection molded directly into the upper cavity. When placed in the upper cavity, the rubber bulkhead simply fits into the upper cavity 142 of the port and is held in the upper cavity by the compression provided by the tight fit with the inner surface of the upper cavity. You can. In one exemplary embodiment, the rubber bulkhead 140 is further adhered to the top cavity 142 to ensure that the rubber bulkhead is detached from the top cavity. In another alternative embodiment, the rubber bulkhead is insert molded with the port and the bulkhead material is glued to the wall of the port.

FIG. 15 is a semi-rough partial perspective cross-sectional side view of the container 10 in which the container port 12 is attached to the additive port 108 of FIG. The additive port 108 may be adhered to the flange 38 of the container port 12 by conventional means. After attaching the additive port 108 to the container port 12, but more preferably prior to this attachment, a sleeve stopper 144, which is a rubber bulkhead manufactured by West Co., is attached to the upper cavity 146 of the additive port.

The sleeve plug 144 includes a male plug 148, a central cutout 150 within the end of the male plug to define the bulkhead thickness so that the needle penetrates with great force, and a flexible skirt portion 152. This flexible skirt portion 152 usually extends away from the male plug 148 before placing the sleeve plug 144 over the additive port 108. After inserting the male plug 148 into the upper cavity 146 of the additive port 108, the skirt 152 is folded back so that the skirt 152 overlaps at least a portion of the outer middle portion 112 of the port 108. In one exemplary embodiment, the male plug 148 and the upper cavity 146 of the additive port include a complementary tapered portion.

FIG. 16 is a semi-rough partial perspective cross-sectional side view of the container 10 having a container port 12 attached to the additive port 72 of FIG. In particular, the fitting flange 80 of the additive port 72 is attached to the flange 38 of the container port 12 by a known radiant heat fusion process. A 13 mm Flip-Off® seal 154 made by West Co. was then sealed in the receiving chamber 96 by a known method, which is a generally cylindrical portion 76 and a tapered portion. Includes crimping the aluminum outer shell 156 to the outer surface of the port at the intersection 86 with 84. Just before using the additive port 72 to add additional drug or drug into the container, the plastic cap 158 is attached by cutting the fragile portion of the aluminum outer shell 156 to which the plastic cap 158 is attached. Is flipped with a finger and removed.

Next, with reference to FIG. 17, this figure shows a semi-schematic partial perspective cross-sectional side view of the two-port assembly 160 realized according to aspects of the present invention. In one exemplary embodiment, the two-port assembly 160 comprises two container ports interconnected by a web 162. These container ports may include container ports 12, 14 shown in FIG. 2, and the web is such that the fins of one port 12 extend and connect with the fins of the other port 14. It may be an extension of the fins or ribs 46.

This two-port assembly 160 has two vessels between the first sheet 16 and the second sheet 18 to provide a fluid communication means for the flexible vessel 10 by a single heat fusion step. Allows ports 12 and 14 to be assembled. For example, the mounting flange 44 for each of these ports may be placed between the first and second seats, and then one or more flat heat dies are used. By doing so, the inner surface of the front seat and the rear seat are fused to the outer surface of the mounting flange 44. This fusion is done by partially melting these surfaces and allowing these melted surfaces to fuse together.

A first vessel port 12 with the set port 124 of FIG. 11 and a second vessel port 14 with the additive port 72 of FIG. 6 are shown, but these particular end ports. 22 is just an example. In practice, any of the terminal ports 22 described above and their associated end caps, rubber bulkheads, and / or inner seals and their equivalents may be used with the two-port assembly 160.

As is readily apparent, in a container 10 containing two or more container ports 12, 14 with an infusion solution, except for at least one container port, which must remain open until after the container is filled. Terminal ports 22 may be attached to more than one container port before the container is filled. However, it is also possible to install terminal ports for all of the container ports after the container is filled.

Next, with reference to FIG. 18, this figure shows a semi-schematic partial perspective cross-sectional side view of the modified container port 164 implemented in accordance with aspects of the present invention. The container port 164 is similar to the container port 12 of FIG. 2 in that it includes a flexible mounting flange 44, fins 46, nozzle 166 and flange 38.

Nozzle 166 at this modified vessel port 164 is adapted to accept a seal sleeve 168 that can slide into the cavity of vessel port 164, and conventional methods such as, for example, a radiant heat fusion process. Glued in place or permanently heat welded. The seal sleeve may also be held by mechanical interference with the nozzle. The seal sleeve 168 includes a generally cylindrical portion having a central punctureable seal 92 located between the two ends 170 of the seal sleeve. The central punctureable seal 92 is integrally molded with the seal sleeve 168 and, in one embodiment, is located near the midpoint between its two ends. The seal sleeves are symmetrical for ease of assembly. When the seal sleeve 68 is permanently attached to container port 164, container port 164 transforms into a set port or drain port that can be used with standard spike assemblies. Therefore, the seal sleeve 168 and nozzle and flange 38 are sized to accept or fit a standard spike assembly.

One or two reduced diameter portions 172 at each end of the seal sleeve 168 are included to facilitate gripping of the spike assembly (not shown) when it is inserted into port 164. You may. The reduced diameter portion 172 is configured to grip a portion of the spike assembly to prevent the spike assembly from coming off the reduced diameter portion. An inner seal may be sealed to flange 38 of container port 164 for sterility. Alternatively, an end cover or cap may be attached to the port.

Although preferred embodiments of the present invention have been described with certain limitations, it is not intended that the description and drawings presented herein are limited, and those skilled in the art will appreciate. It will be appreciated that various changes may be made to the embodiments described herein without deviation from the scope of the invention, and all of these changes and modifications are attached. It is intended to be included within the scope of the claims. A variety of containers containing one or more flat ports, including flexible mounting flanges for heat-sealing one or more ports to the front and rear seats of the container with a flat heat bar. Modifications may be made without deviation from the ideas and scope of the invention. For example, the dimensions of the ports and containers can vary, the percentage of material composition can vary, and the materials can vary. Other modifications are to use different end ports for different rubber bulkheads, to mix or add colors, to label container components, and to form containers with multiple compartments. It involves adding ports to multiple end edges of the container with a peelable seal and using different adhesive means to join the various container ports, end ports and end caps. Therefore, various changes and modifications may be made by one of ordinary skill in the art without deviation from the ideas and scope of the invention.