WO2002017847A1

WO2002017847A1 - Flexible container for enteral feeding fluids

Info

Publication number: WO2002017847A1
Application number: PCT/US2000/024307
Authority: WO
Inventors: Martin Vazquez; Ross Magladry; Fernando Cadena
Original assignee: Venusa, Ltd.
Priority date: 2000-08-31
Filing date: 2000-08-31
Publication date: 2002-03-07
Also published as: AU2000271126A1

Abstract

A flexible container for enteral feeding fluids includes a hollow body section. At the top of the hollow body section is a normally closed, push-to-open closure or valve. Beneath the normally closed, push-to-open closure or valve is a substantially conical lay flat valve.

Description

Title: FLEXIBLE CONTAINER FOR ENTERAL FEEDING FLUIDS

FIELD

The present invention pertains to flexible containers ; 5 more particularly, the present invention pertains to flexible containers generally used for the storage of enteral feeding fluids .

BACKGROUND

Prior art flexible containers for the containment of an

.0 enteral feeding fluid typically consist of a rigid/semi-rigid inflow port which includes a funnel/cap assembly, and a soft tubular outflow port all contained in an elongated envelope formed of plastic film.

Prior art flexible containers require the use of both .5 hands to open and close the fillport/cap. If the cap on top of the fillport is not closed correctly, there is a potential for leakage or spilling fluid from the flexible container when it is stored in a horizontal position. In addition, prior art flexible container designs are bulky and !0 often require a significant amount of shelf space for storage .

Prior art flexible containers have traditionally been manufactured using RF sealing technology to both seal the sides of the container and attach the ports . The use of RF

.5 sealing technology limits the selection of the plastic materials from which the containers may be made to PVC

(polyvinyl chloride) and EVA (ethyl vinyl acetate) .

Accordingly, a need remains in the art for a low cost, flexible container which may be easily used and operated SO with one hand, which will not leak when placed in the horizontal position, and is easily manufactured.

SUMMARY

The low cost flexible container of the present invention may be easily used and operated with one hand, does not leak 5 in the horizontal position, and is easily manufactured.

Disclosed herein is a flexible container for enteral feeding fluids which includes a hollow body section defined by spaced apart opposing walls. The hollow body section is formed from a plastic resinous material. At the top of the hollow body section is a normally closed, push-to-open closure or valve. A neck may be disposed between the top of the hollow body section and the closure or valve. The normally closed push-to-open closure or valve includes a pair of flat parallel spring strips which may be affixed to the plastic resinous material by adhesive/solvent bonding, ultrasound, heat sealing or encapsulation in the plastic resinous material. Access to the interior of the hollow body of the flexible container is obtained by flexing the pair of flat parallel string strips away from one another to form an opening therebetween.

In the preferred embodiment, downstream from the normally closed, push-to-open closure is a substantially conical lay flat valve. When the normally closed, push-to-open closure or valve is closed, the substantially conical lay flat valve is in a flattened condition. When the normally closed, push-to-open closure is opened, the substantially conical lay flat valve may be opened up to provide a port for filling the flexible container with an enteral feeding fluid or any other similar type fluid used in medical, veterinary or similar applications. BRIEF DESCRIPTION OF THE FIGURES A better understanding of the flexible container for enteral feeding or similar fluids may be had by reference to the drawing figures wherein:

FIGURE 1 is a front elevational view of the flexible container of the present invention; FIGURE 2 is a perspective view of the container shown in Figure 1 with the top and substantially conical lay flat closure valve in a partially opened condition;

FIGURE 3 is a side elevational view in partial section taken at 3-3 of Figure 2 but showing enteral feeding fluid within the container and the top closure and substantially conical lay flat valve in a closed condition;

FIGURE 4 is a top plan view of an alternate embodiment of the present invention showing an antibacterial barrier within the top closure;

FIGURE 5 is a sectional view taken at 5-5 of Figure 4; FIGURE 6 is an elevational view of an alternative embodiment of the flexible container of the present invention; and

FIGURE 7 is a schematic view of the process used to manufacture the flexible container of the present invention. DESCRIPTION OF THE EMBODIMENTS As may be seen in Figures 1, 2 and 3, the preferred embodiment of the container 10 of the present invention includes a hollow body section 20, a port member 12 at the bottom of the hollow body section 20 together with a normally closed, push-to-open closure 30 and a substantially conical lay flat valve 42 at the top of the hollow body section 20. Closure 30 and lay flat valve 42 form a normally flat fillport assembly 40. As best seen by comparing Fig. 2 and Fig. 3, the substantially conical lay flat valve assembly 42 is contained within the hollow body section 20. When open, as shown in Fig. 2, the substantially conical lay flat valve 42 provides a substantially circular and conical flow path 14 into the interior of the hollow body section 20 (i.e., downstream from the closure 30) and, as may be seen in Figure 3, the fluid stored within the hollow body section 20 will push the sides of the substantially conical lay flat valve 42 together.

A still better understanding of the flexible container 10 of the present invention may be had by noting that the container is primarily used for the storage of enteral feeding fluid 100. The hollow body section 20 includes two opposing walls 22 which are connected together by perimeter seal 24. The sealing of the wall members 22, one to another, around their perimeter forms a compartment 18 between the wall members in which an enteral feeding fluid 100 or any other type of fluid may be contained. Similarly, the substantially conical lay flat valve 42 has opposing

5 walls 45 connected, one to another, by an edge seal 46.

As previously indicated, a normally-closed, push-to-open closure 30 is formed at the top of the hollow body section

20. This normally-closed, push-to-open closure 30 is formed by a pair of normally flat parallel spring strips or leaf

10 spring pieces which are attached to the hollow body section

20 by adhesive/solvent bonding, ultrasound, heat sealing or encapsulation in the plastic resinous material of the hollow body section 20. These normally flat, parallel, resilient spring strips 32, when placed one against another, form a

L5 seal at the top of the hollow body section 20. This seal prevents leakage of the contents of the container 10 when the container 10 is in a horizontal orientation, such as that shown in Fig. 3. And, as may be further seen in Fig. 3, the tendency of the two flat parallel spring strips 32

20 to remain in a substantially flat condition also causes the substantially conical lay flat valve assembly 42, which

" extends into the interior of the hollow body section 20, to close .

When it is desired to open the container 10, one needs

25 merely exert force F on either end of the two flat parallel string strips 32 as shown in Fig. 2. This force F will cause the two flat parallel spring strips 32 to bend, biasing them away from one another. If desired, a substantially circular opening 16 may be formed by an

30 appropriate level of force F, which causes the two flat parallel spring strips 32 to bend into a substantially semicircular arc. Because the substantially conical lay flat valve assembly 42 is formed substantially into the shape of a triangle (Fig. 4) when the container 10 is in its flat position, opening of the normally closed, push-to-open closure 30 will cause the lay flat valve 42 to expand into the shape of a conical flow path 14.

5 In the alternate embodiment 110 shown in Fig. 4 and

Fig. 5 an antibacterial barrier or additional fluid seal may be placed in the normally closed, push-to-open closure 30.

This antibacterial barrier is made by placing two insert pieces 133 between the pair of flat parallel spring strips

10 132. As may be seen in Fig. 5, these two insert pieces 133 may include bumps, undulations, or protrusions 136 to form a tortuous path 137 which prevents the passage of bacteria into the hollow body section 120. The insert pieces 133 may be made separately from the spring strips 132 and attached

L5 or adhered to the spring strips 132 using any number of techniques well known to those skilled in the art (e.g. adhesive, channel locks, etc.) . The insert pieces 133 may also be formed as an integral part of the spring strips 132 by thermoforming the desired protrusion geometry directly on _0 to the spring strips 132 so as to create the tortuous path

137 between them.

Fig. 6 illustrates an alternative embodiment of the container 10 of the present invention. In this case, the hollow body section 20 is joined to the normally flat

_5 fillport assembly 40 using a neck 55, which extends the length of the normally flat fillport assembly 40 by joining the top 57 of the hollow body section 20 and the bottom 58 of the closure 30. Thus, the neck 55 is disposed between the hollow body section 20 and the closure 30. The neck 55

.0 follows the profile of the normally-closed, push-to-open closure 30, such that the neck 55 lays flat until the spring strips 32 are biased away from one another, whereupon the neck 55 opens to admit filling material into the hollow body section 20. Thus, the normally-flat flow channel extending into the hollow body section 20 from the opening in the assembly 40 includes the neck 55.

5 A still better understanding of the container 10 of the instant invention may be had by reference to Fig. 7 which depicts the process by which the container of the present invention is manufactured.

Moving from right to left, it may be seen that a roll L0 200 of bag film 201 passes through a guide roll assembly

202. The bag film 201 is then caused to fold on itself by passing through a folding guide assembly 204. Once having passed through the folding guide assembly 204, the film 201 is joined by spring material 207 (e.g., metal or plastic)

L5 which is unwound from rolls 206 located on either side of the moving bag film 201. Following the rolls 206 of spring material 207 is located a partition knife 208. Following the partition knife 208 is a top valve seal assembly 210. Once the film 201 has passed the top valve seal assembly 210

_0 it is directed to a reorientation fixture 212. Once having passed the reorientation fixture 212, the film 201 is formed into an envelope by a perimeter seal assembly 214. Once having passed the perimeter seal assembly 214, a hole punch assembly 216, separates the top portions of the containers

_5 10 one from another. Once having passed the hole punch assembly 216 the newly formed containers pass an outflow port seal assembly 218. Once having passed the outflow port seal assembly 218, the containers 10 are ready for filling.

The container 10 of the present invention allows

J0 multiple manufacturing processes for sealing both the opposing walls 22 of the hollow body section 20 together and for sealing the closure 30 and outflow port 12. These sealing processes include RF sealing, heat-bar, ultrasonic and/or impulse sealing. Because of the wide variety of sealing technologies made available by the design of the disclosed container 10 it is possible to use materials

5 beyond the commonly used bag materials PVC and/or EVA. Such alternate materials can be laminations like LDPE/PET (low- density polyethylene/polyester) , which are commonly used in the food packaging industry. These materials have equivalent performance properties and much wider printing schemes than L0 are typically available for PVC roll stock.

It will be understood by those of ordinary skill in the art that by using flat parallel spring strips 32 in closure

30 at the top of the container 10, it is possible to construct the closure 30 from the same or similar film

L5 material as the hollow body section 20. The ability to construct the top closure 30 from the same material as the hollow body section 20 eliminates the need for additional parts and tools to produce the top closure 30.

Users of the disclosed flexible container will also

20 understand that the placement of two flexible spring strips

32 at the top of the hollow body section 20 enables holding the container 10 and opening the closure 30 with one hand.

This allows the user's other hand to pour fluid into the container 10. Closure of the container 10 is automatic as

25 the leaf springs or spring strips 32 return to their unflexed position. With the spring strips 32 in their unflexed position, the container 10 can easily be stored in a horizontal position without fluid spillage. The present container design is also less bulky than prior art container 30 designs. This reduction in bulkiness produces packaging efficiencies and reduces the shelf storage space required.

Those of ordinary skill in the art will understand that the flexible flat bars 32 which enable the operation of the closure 30 at the top of the container 10 add rigidity to the port and assure easy opening (by curving) and closure (by laying flat) . As previously indicated, the flat spring strips 32 can be attached to the film from which the container 10 bag is formed by adhesive/solvent bonding, ultrasonic techniques, heat sealing, encapsulation in the plastic resinous film, or by other techniques known to those of ordinary skill in the art. The out flow port 12 at the bottom of the container 10 is typically a plastic fitting which may be heat sealed, adhesive/solvent bonded or attached to the material from which the container 10 is made, or by using other techniques known to those of ordinary skill in the art .

While the foregoing invention has been described by reference to its preferred and alternate embodiments, those of ordinary skill in the art will understand that numerous other embodiments of the flexible container of the present invention are enabled by the foregoing disclosure. Such other embodiments shall be included within the scope and meaning of the appended claims .

Claims

What is claimed is: 1. A flexible container comprising: a hollow body section defined by spaced apart opposing walls formed from a plastic resinous material; said hollow body section including a normally-closed, push-to-open closure; said normally-closed, push-to-open closure including a pair of flat parallel spring strips affixed to said plastic resinous material; whereby access to the interior of said hollow body section is obtained by flexing said pair of flat parallel spring strips away from one another to form an opening therebetween.

2. The flexible container as defined in claim 1 further including a tortuous fluid path between said pair of flat parallel spring strips .

3. The flexible container as defined in claim 1 further including a fluid seal between said pair of flat parallel spring strips.

4. The flexible container as defined in claim 1 further including a lay flat flow path formed within the interior of said hollow body section downstream from said normally-closed, push-to-open closure.

5. The flexible container as defined in claim 4 wherein said lay flat flow path is substantially conical .

6. The flexible container as defined in Claim 1 further including a neck disposed between the hollow body section and the normally-closed, push-to-open closure.

7. A container having a quantity of liquid therein comprising: a hollow body formed of a plastic material; said hollow body including a normally flat fillport assembly; said normally flat fillport assembly including a substantially conical lay flat valve,- said normally flat fillport assembly including two resilient spring strips affixed to said plastic material; whereby access to the interior of said hollow body is obtained by biasing said two resilient spring strips away from one another to open said substantially conical lay flat valve to form a flow path into, the interior of said hollow body.

8. The container as defined in claim 7 further including a tortuous flow path between said two resilient spring strips .

9. The container as defined in claim 7 further including a fluid seal between said two resilient spring strips .

10. The container as defined in Claim 7 including a neck joined to the hollow body and the normally flat fillport assembly.

11. A device for containing a fluid comprising: a hollow container formed of a flexible thermoplastic material having at least one port; said container further including a spring biased fill opening; said spring biased fill opening including a first leaf spring and a second leaf spring; said first leaf spring and said second leaf spring being oriented one over another and each individually affixed to said thermoplastic material; a substantially circular flow path positioned under said first and second leaf springs; whereby the biasing of said first and second leaf springs away from one another provides access to the interior of said hollow container and opens said substantially circular flow path.

12. The device as defined in claim 11 further including an anti-bacterial barrier between said first and second leaf springs .

13. The device as defined in claim 12 wherein said anti-bacterial barrier is a tortuous path.

14. The device as defined in claim 12 wherein said anti-bacterial barrier is a fluid seal.

15. The device as defined in claim 11 wherein said substantially circular flow path is conically shaped.

16. The device as defined in claim 11 including a neck disposed between the hollow container and the spring biased fill opening.

17. A system for the storage of enteral feeding fluids comprising: a flexible plastic container having two wall means defining a compartment therebetween for the enteral feeding fluid and a port member for dispensing the enteral feeding fluid; each of said two wall means being affixed to a normally-flat resilient member constructed and arranged to surround an opening, said opening providing access to said compartment; a normally-flat flow channel extending into said compartment from said opening; whereby when said normally-flat resilient members are positioned adjacent one to another in their flattened condition, said normally flat flow channel is closed and when said normally-flat resilient members are biased away from one another access is provided to said compartment and said normally-flat flow channel is opened.

18. The system as defined in claim 17 further including an anti-bacterial barrier between said normally flat resilient members .

19. The system as defined in claim 18 wherein said anti-bacterial barrier is a tortuous path.

20. The system as defined in claim 18 wherein said anti-bacterial barrier is a fluid seal.

21. The system as defined in claim 17 wherein said normally flat flow channel is formed substantially in the shape of a triangle .

22. The system as defined in claim 17 wherein the normally-flat flow channel includes a neck.

23. A method for enclosing an enteral feeding fluid in a flexible plastic container containing a fill opening, said method containing the steps of : surrounding the fill opening with a pair of normally-flat spring members to close the fill opening and when filled with enteral feeding fluid to prevent the passage of enteral feeding fluid from the container; affixing the pair of normally-flat spring members to the flexible plastic,- whereby access to the interior of the container is obtained by biasing the normally-flat spring members away from one another into a substantially circular opening.

24. The method as defined in claim 23 wherein the fill opening also includes a flow path extending into the interior of the flexible plastic container.