GB1598777A

GB1598777A - Aseptic storage container

Info

Publication number: GB1598777A
Application number: GB18264/78A
Authority: GB
Original assignee: Pennwalt Corp
Current assignee: Pennwalt Corp
Priority date: 1978-05-08
Filing date: 1978-05-08
Publication date: 1981-09-23
Also published as: NL7805502A; DE2821556A1

Description

(54) ASEPTIC STORAGE CONTAINER (71) We, PENNWALT CORPORATION, a corporation duly organised and existing under the laws of the State of Pennsylvania, United States of America, of Pennwalt Building, Three Parkway, Philadelphia, Pennsylvania 19102, United States of America, do hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement This invention relates to flexible containers for aseptically storing blood and to access ports for such containers.

Flexible containers for aseptically storing blood are known; one is disclosed in United States patent 3,509,879. Access ports for such containers, such as the ports illustrated in Figures 2, 3 and 4 of the '879 patent, typically have puncturable membranes across the area of the port; fluid stored in the container is removed by first penetrating the membrane with an aseptic fluid feed puncturing spike and then drawing off the fluid through a flexible tube connected to the spike. Such access port-penetrable membrane combinations are conventionally assembled of two or more structures bonded together at chosen mating surfaces, as described at line 8, column 2 of the '879 patent. Access ports requiring such fusion are expensive to fabricate.Additionally, there is a risk that when the puncturing spike is inserted, the spike will be pushed through the access port far enough to puncture the flexible wall of the container if the flexible wall happens to be folded against the proximal end of the port, where the port is secured to the container.

Puncture of the container wall contaminates the aseptic fluid.

In one aspect this invention provides a flexible container for aseptically storing fluid materials comprising a flexible pouch formed of flexible plastics material, a sealable inlet for charging fluid to the pouch for storage therein under aseptic conditions, and a sealed outlet puncturable by a hollow needle for the subsequent discharge of the fluid from the pouch under aseptic conditions, wherein the outlet comprises an integrally formed, injection moulded plastics member comprising an outlet tube having a base flange formed at one end thereof and sealed to the flexible pouch around an outlet aperture therein, said flange serving to reinforce said pouch in the region of said outlet aperture, and a membrane puncturable by said needle extending internally across and sealing said tube intermediate its ends, said tube further having, on the opposite sides of said membrane, internal surfaces which taper inwardly towards the membrane from the opposite ends of the tube, and having along a part of its length a section which is of greater external diameter than the external diameter of the tube over the remainder of its length.

In a second aspect, this invention provides an outlet for a flexible container as defined above and comprising an integrally formed, injection moulded plastics member comprises ing an outlet tube having a base flange formed at one end thereof and sealable to the flexible pouch around an outlet aperture therein, and a puncturable membrane extending internally across and sealing said tube intermediate its ends, said tube further having, on opposite sides of the membrane internal surfaces which taper inwardly towards the membrane from the opposite ends of the tube, and having along part of its length a section which is of greater external diameter than the external diameter of the tube over the remainder of its length.

The invention will be further described with reference to the accompanying drawings, in which: Figure 1 is a perspective view of a container and aseptic access port embodying the invention with an aseptic fluid feed puncturing spike ready to enter the access port.

Figure 2 is a sectional view of the access port taken as indicated by arrows 2-2 in Figure 1.

Figure 3 is a sectional view taken as indicated by arrows 3-3 in Figure 2, showing the fluid outlet tube of the access port in side elevation.

Figure 4 is a sectional view taken as indicated by arrows 2-2 in Figure 1, with a fluid feed puncturing spike within the fluid outlet tube.

Figure 5 is an enlarged sectional view taken as indicated by rectangle 5 in Figure 4.

Figure 6 is a side view of a fluid feed puncturing spike.

Referring to Figure 1, the container for aseptically storing blood or other fluid is designated generally 10 and includes a flexible confining wall 14 and an aseptic access port designated generally 12. Container 10 is preferably transparent and is formed by sealing two layers of confining wall 14 along boundary 15. Apertures 17 in the boundaries of container 10 are for suspending container 10 from a suitable hook, not shown, as the container is filled or emptied.

Asceptic access port 12 includes a base 16 which reinforces the portion of wall 14 where the base and wall are in contact, a fluid outlet tube 18 extending outwardly from base 16, a membrane (not visible in Figure 1) sealing outlet tube 18 and a shoulder 26 concentric about outlet tube 18. Base 16 extends radially about the circumference of outlet tube 18, where outlet tube 18 communicates with container 10. Base 16, outlet tube 18, the membrane closing outlet tube 18 and shoulder 26 are injection molded as a unitary piece of molded plastic with molding done as a single stage operation.

In Figure 1 an aseptic fluid feed puncturing spike 28 is illustrated above access port 16, ready to puncture the membrane to remove fluid from container 10. A fluid inlet tube 40 is connected to a fluid inlet tube portion of the access port.

Referring to Figure 2, the membrane 20 comprises a thin sheet across the interior of fluid outlet tube 18, preferably positioned close to the midpoint of tube 18. The membrane 20 is penetrable by a standard aseptic fluid feed puncturing spike when the spike is thrust therethrough by hand. A flange 30 is circumferential about outlet tube 18, coplanar with tube 18's distal end, remote from base 16. Flange 30 is preferably injection molded as a portion of the unitary piece of plastic which includes outlet tube 18, membrane 20, shoulder 26 and base 16.

Shoulder 26 is circumferential about tube 18 and may be located at the tube distal end, as illustrated in Figure 2, or at the base end.

Alternatively the shoulder may be replaced by a section of the tube 18 intermediate the ends thereof which is of greater external diameter than the rest of the tube. A circumferential bead 32 about shoulder 26 may also be provided.

Shoulder 26 and, when provided, bead 32 facilitate single stage injection molding of the access port. When a mold gate in the access port mold is provided at location D in Figure 2, the access port may be molded in a single stage molding operation. Shoulder 26 and bead 32, as additional recesses in the mold, encourage injected plastic material to initially form a cylinder at shoulder 26 as the material is injected into the mold. Shoulder 26 and the portion of the outlet tube surrounded thereby form prior to the remainder of outlet tube 18 due to the combined crosssectional area (in the axial direction) of tube 18 and shoulder 26 being greater than that of the remainder oftube 18.The flowing plastic, taking the path of least resistance, first occupies this relatively large open volume, initially forming shoulder 26 and the portion of tube 18 surrounded thereby. Once this shoulder-tube portion has formed, continued application of injection pressure to plastic material entering the mold causes the material to flow substantially uniformly down the remaining length of outlet tube 18, forming the membrane 20 in the process. Once tube 18 is completely formed, continued application of injection pressure, as more material is injected, causes the plastic material to continue to flow, forming base 16 and fluid inlet tube 36.

If no shoulder such as shoulder 26 is provided, as the plastic material is injected into the mold it will flow down the portion of the mold which forms one side of tube 18; the material will not flow circumferentially to form the complete circumference of tube 18 as the plastic flows in the axial direction.

Such a pattern of flow results in the left-hand side of tube 18 (viewed in Figure 2) forming prior to the right-hand side. This delayed forming of a portion of tube 18 results in either improper formation or no formation of the membrane 20. Failure of membrane 20 to properly form during the injection molding process, when no shoulder-forming recess is provided in the access port mold, is due to the extremely small thickness of membrane 20 relative to the cross-sectional areas, in the direction of plastic material flow, of all other portions of access port 16.

Inner diameter of tube 18 tapers from a first greater inner diameter, at the end of tube 18 at which base 16 is formed, to a first lesser inner diameter at the side of membrane 20 closer to base 16. Inner diameter of tube 18 also tapers from a second greater inner diameter, at the end of tube 18 where flange 30 is formed, to a second lesser inner diameter at the side of pellicular seal means 20 more proximate that end oftube 18. These two tapers allow retractable portions of the access port mold, which occupy volume which becomes the hollow interior of tube 18, to be successfully removed from tube 18 when the access port has been molded.

Referring to Figure 3, shoulder 26 and bead 32, formed proximate flange 30, may equally well be at the other end of tube 18, where base 16 is attached thereto. The location of shoulder 26 and bead 32 is dictated by the position of the mold gate through which plastic is injected to form the access port. If the mold gate is located at the other end of tube 18, in the position shown by arrow E in Figure 2, it is necessary for shoulder 26 and bead 32 to similarly be at this end of tube 18, to ensure uniform flow of plastic in the axial direction as the plastic forms tube 18, for pellicular seal means 20 to properly form as the access port is injection molded.Similarly, if the enlargement or shoulder 26 is positioned at an intermediate location aong the length of tube 18, the mold gate must be located at the shoulder, so that as plastic material is injected into the mold to form the access port, the shoulder and the portion of tube 18 surrounded by the shoulder form before any other portion of the access port. Initial formation of the shoulder and the portion of tube 18 surrounded by the shoulder ensures uniform flow of plastic in the axial direction as the plastic forms the wall of tube 18 and hence ensures that membrane 20 forms properly.

Refering to Figures 4 and 5, as an aseptic fluid feed puncturing spike 28 is inserted into tube 18 and is forced toward base 16, the tip 38 of the puncturing spike ruptures membrane 20. As the spike is inserted further into tube 18, past membrane 20, the rent portions of membrane 20, designated 20a and 20b in Figure 5, seal against the periphery of spike 28. This prevents contamination of container 10.

The access port is designed with dimension C in Figure 2 in excess of the distance from the circumferential collar 46 to the tip 38 of a standard aseptic fluid feed puncturing spike.

This distance is designated F in Figure 6.

The aseptic access port is preferably constructed with inner diameter of tube 18, in area A in Figure 2, tapering from a first greater inner diameter of about 0.217 inches, at the end of tube 18 to which base 16 is affixed, to a first lesser inner diameter of about 0.208 inches at membrane 20, and with inner diameter of tube 18, in area B in Figure 2, tapering from a second greater inner diameter of 0.212 inches at the end of tube 18 where flange 30 is affixed, to a second lesser inner diameter of about 0.204 inches at membrane 20. The outlet tube wall is from about 0.013 inches to about 0.015 inches thick. Shoulder 26 is from about 0.015 inches to about 0.019 inches thick. Thus the thickness of the tube-shoulder combination is from about 0.028 inches to about 0.034 inches.Membrane 20 is about 0.003 inches thick at its edge, where it contacts outlet tube 18 and, in some cases, is fabricated with a thicker middle portion, with middle thickness ranging up to about 0.020 inches.

Aseptic fluid feed puncturing spikes generally have a handle flange diameter, designated G in Figure 6, of about 1 inch.

Dimension F in Figure 6 is referred to as the probe length and is likewise generally about 1 inch, with the maximum about 1 and 3/16 inches. The aseptic access port is preferably constructed with dimension C in Figure 2 of about 1 and 1/4 inches so that even if the spike is thrust completely into tube 18, until spike collar 46 contacts and interferes with access port flange 30, tip 38 does not penetrate the plane of base 16. This ensures that there is no danger of the probe accidentally puncturing wall 14 of container 10.

Peel strip 34 illustrated in Figure 3 may be affixed to the distal surface of flange 30 by a conventional heat seal or by any suitable adhesive which does not contaminate fluid in container 10.

The container and aseptic access port are preferably formed of transparent flexible plastic material. Any aseptically noncontaminating plastic conventionally used for injection molding may be used for fabrication of the access port.

WHAT WE CLAIM IS: 1. A flexible container for aseptically storing fluid materials comprising a flexible pouch formed of flexible plastics material, a sealable inlet for charging fluid to the pouch for storage therein under aseptic conditions, and a sealed outlet puncturable by a hollow needle for the subsequent discharge of the fluid from the pouch under aseptic conditions, wherein the outlet comprises an integrally formed, injection moulded plastics member comprising an outlet tube having a base flange formed at one end thereof and sealed to the flexible pouch around an outlet aperture therein, said flange serving to reinforce said pouch in the region of said outlet aperture, and a membrane puncturable by said needle extending internally across and sealing said tube intermediate its ends, said tube further having, on the opposite sides of said membrane, internal surfaces which taper inwardly towards the membrane from the opposite ends of the tube, and having along a part of its length a section which is of greater external diameter than the external diameter of the tube over the remainder of its length.

2. A container according to claim 1, wherein the end of the outlet tube remote from said base flange has an integrally formed end flange extending radially therefrom.

3. A container according to claim 1 or 2, wherein said section of greater external diameter is located adjacent one end of the tube.

4. A container according to claim 3, wherein said section of greater external diameter forms a shoulder adjacent said base flange.

5. A container according to claim 3, as

**WARNING** end of DESC field may overlap start of CLMS **.

Claims

**WARNING** start of CLMS field may overlap end of DESC **. dictated by the position of the mold gate through which plastic is injected to form the access port. If the mold gate is located at the other end of tube 18, in the position shown by arrow E in Figure 2, it is necessary for shoulder 26 and bead 32 to similarly be at this end of tube 18, to ensure uniform flow of plastic in the axial direction as the plastic forms tube 18, for pellicular seal means 20 to properly form as the access port is injection molded. Similarly, if the enlargement or shoulder 26 is positioned at an intermediate location aong the length of tube 18, the mold gate must be located at the shoulder, so that as plastic material is injected into the mold to form the access port, the shoulder and the portion of tube 18 surrounded by the shoulder form before any other portion of the access port.Initial formation of the shoulder and the portion of tube 18 surrounded by the shoulder ensures uniform flow of plastic in the axial direction as the plastic forms the wall of tube 18 and hence ensures that membrane 20 forms properly. Refering to Figures 4 and 5, as an aseptic fluid feed puncturing spike 28 is inserted into tube 18 and is forced toward base 16, the tip 38 of the puncturing spike ruptures membrane 20. As the spike is inserted further into tube 18, past membrane 20, the rent portions of membrane 20, designated 20a and 20b in Figure 5, seal against the periphery of spike 28. This prevents contamination of container 10. The access port is designed with dimension C in Figure 2 in excess of the distance from the circumferential collar 46 to the tip 38 of a standard aseptic fluid feed puncturing spike. This distance is designated F in Figure 6. The aseptic access port is preferably constructed with inner diameter of tube 18, in area A in Figure 2, tapering from a first greater inner diameter of about 0.217 inches, at the end of tube 18 to which base 16 is affixed, to a first lesser inner diameter of about 0.208 inches at membrane 20, and with inner diameter of tube 18, in area B in Figure 2, tapering from a second greater inner diameter of 0.212 inches at the end of tube 18 where flange 30 is affixed, to a second lesser inner diameter of about 0.204 inches at membrane 20. The outlet tube wall is from about 0.013 inches to about 0.015 inches thick. Shoulder 26 is from about 0.015 inches to about 0.019 inches thick. Thus the thickness of the tube-shoulder combination is from about 0.028 inches to about 0.034 inches.Membrane 20 is about 0.003 inches thick at its edge, where it contacts outlet tube 18 and, in some cases, is fabricated with a thicker middle portion, with middle thickness ranging up to about 0.020 inches. Aseptic fluid feed puncturing spikes generally have a handle flange diameter, designated G in Figure 6, of about 1 inch. Dimension F in Figure 6 is referred to as the probe length and is likewise generally about 1 inch, with the maximum about 1 and 3/16 inches. The aseptic access port is preferably constructed with dimension C in Figure 2 of about 1 and 1/4 inches so that even if the spike is thrust completely into tube 18, until spike collar 46 contacts and interferes with access port flange 30, tip 38 does not penetrate the plane of base 16. This ensures that there is no danger of the probe accidentally puncturing wall 14 of container 10. Peel strip 34 illustrated in Figure 3 may be affixed to the distal surface of flange 30 by a conventional heat seal or by any suitable adhesive which does not contaminate fluid in container 10. The container and aseptic access port are preferably formed of transparent flexible plastic material. Any aseptically noncontaminating plastic conventionally used for injection molding may be used for fabrication of the access port. WHAT WE CLAIM IS:

1. A flexible container for aseptically storing fluid materials comprising a flexible pouch formed of flexible plastics material, a sealable inlet for charging fluid to the pouch for storage therein under aseptic conditions, and a sealed outlet puncturable by a hollow needle for the subsequent discharge of the fluid from the pouch under aseptic conditions, wherein the outlet comprises an integrally formed, injection moulded plastics member comprising an outlet tube having a base flange formed at one end thereof and sealed to the flexible pouch around an outlet aperture therein, said flange serving to reinforce said pouch in the region of said outlet aperture, and a membrane puncturable by said needle extending internally across and sealing said tube intermediate its ends, said tube further having, on the opposite sides of said membrane, internal surfaces which taper inwardly towards the membrane from the opposite ends of the tube, and having along a part of its length a section which is of greater external diameter than the external diameter of the tube over the remainder of its length.

5. A container according to claim 3, as

dependent on claim 2, wherein said section of greater external diameter forms a shoulder adjacent said end flange.

6. A container according to any one of the preceding claims, wherein said section of greater external diameter has an integrally formed annular bead extending therearound intermediate the ends thereof.

7. A container according to any one of the preceding claims, wherein the outer end of the outlet tube remote from the base flange is sealed by a peel-off sealing strip.

8. A container according to any one of the preceding claims, wherein said inlet comprises a second tube integrally moulded with and extending from said base flange at a location spaced from said outlet tube, said inlet tube being sealable after introduction of the fluid material into the pouch, thereby to seal the fluid in the pouch under aseptic conditions.

9. A container according to claim 1, substantially as hereinbefore described with reference to the accompanying drawings.

10. An outlet for a container as claimed in claim 1 and comprising an integrally formed, injection moulded plastics member comprising an outlet tube having a base flange formed at one end thereof and sealable to the flexible pouch around an outlet aperture therein, and a puncturable membrane extending internally across and sealing said tube intermediate its ends, said tube further having, on opposite sides of the membrane internal surfaces which taper inwardly towards the membrane from the opposite ends of the tube, and having along part of its length a section which is of greater external diameter than the external diameter of the tube over the remainder of its length.

11. An outlet according to claim 10, additionally having the feature or features called for by any of claims 2-8.

12. An outlet according to claim 10, substantially as hereinbefore described with reference to Figs. 2-5 of the accompanying drawings.