AU2011204932A1 - Fluid bag port and fluid bag - Google Patents

Abstract

A fluid bag port comprising a moveable plug positioned in a fluid bag opening of the fluid bag port and forming a seal so that fluid can not pass the seal in either direction is described. The fluid bag port may also comprise a tube 5 defining a channel in which the moveable plug is positioned. The moveable plug may be a sphere, a cube, a cone, a pyramid or screw-shaped. A fluid bag comprising the fluid bag port, a method of manufacturing the fluid bag port or fluid bag, a method of assembling a fluid bag, a method of using the fluid bag to access stored fluid and a kit comprising the fluid bag are also 10 described. C)

Description

P/00/011 Regulation 3.2 AUSTRALIA Patents Act 1990 ORIGINAL COMPLETE SPECIFICATION STANDARD PATENT Invention Title: "FLUID BAG PORT AND FLUID BAG" The following statement is a full description of this invention, including the best method of performing it known to me/us: 1 TITLE FLUID BAG PORT AND FLUID BAG FIELD OF THE INVENTION The present invention relates to a fluid bag port and a fluid bag. In 5 particular, but not exclusively, the present invention relates to a fluid bag port that comprises a moveable plug and a fluid bag comprising the fluid bag port. Preferably, the moveable plug is positioned in a fluid bag opening of the fluid bag port. The fluid bag port is suitable for biological solutions such as, blood and plasma, and chemical solutions such as, water, saline and buffers. 10 BACKGROUND TO THE INVENTION Conventional fluid bags require the use of a sharp needle to penetrate a seal. The requirement of a sharp needle means the risk of needle-stick injuries is always present. Additionally, the disposal of sharp needles is cumbersome and expensive. 15 Accordingly there is a clear need for alternative fluid bags. OBJECT OF THE INVENTION It is an object of this invention to overcome and/or alleviate one or more of the above disadvantages of the prior art and/or provide the consumer with a useful or commercial choice. 20 Further objects will be evident from the following description. SUMMARY OF THE INVENTION The present invention is broadly directed to providing a fluid bag port, and a fluid bag as well as methods of manufacturing a fluid bag port and a fluid bag and a method of using a fluid bag port and bag. Of significant 2 advantage the fluid bag port of the invention may comprise a moveable plug positioned in a fluid bag opening of the port. The present inventor has provided a novel and inventive fluid bag port that eliminates the requirement for a needle to penetrate the fluid bag port seal. 5 The fluid bag, fluid bag port and methods of the invention are of significant advantage because they eliminate the requirement for a sharp needle. This is of great advantage for safety reasons because it eliminates the risk of needle-stick injuries. The present invention is also of significant advantage commercially because the cost and effort related to sharps 10 storage and disposal is also eliminated. In a first aspect, although it need not be the only, or indeed the broadest aspect, the invention resides in a fluid bag port comprising a moveable plug positioned in a fluid bag opening of the fluid bag port and forming a seal so that fluid can not pass the seal in either direction. 15 The fluid bag port may also comprise a tube defining a channel wherein the moveable plug is positioned within the channel. In a second aspect the invention resides in a fluid bag comprising one or more fluid bag port according to the first aspect. In a third aspect the invention resides in a fluid bag comprising one or 20 more fluid bag port comprising a moveable plug positioned in a fluid bag opening of at least one of the one or more fluid bag port, the moveable plug forming a seal so that fluid can not pass the seal in either direction. According to the third aspect the one or more fluid bag port may also comprise a tube defining a channel to access contents of the fluid bag, 3 wherein the moveable plug is positioned within the channel. According to the second or third aspect the fluid bag may comprise two fluid bag ports. The two fluid bag ports may be located either side of a central port. 5 The central port may comprise a probe for dislodging the moveable plug. The probe may comprise a slot adjacent a probe tip. In a fourth aspect the invention resides in a method of manufacturing a fluid bag port including the step of: 10 installing and/or inserting a moveable plug in a fluid bag opening of the fluid bag port thereby forming a seal so that fluid can not pass the seal in either direction and so that the moveable plug may be ejected from the fluid bag port to eliminate the seal and to thereby manufacture the fluid bag port. In a fifth aspect the invention resides in a method of manufacturing a 15 fluid bag including the steps of: installing and/or inserting a moveable plug in a fluid bag opening of one or more fluid bag port thereby forming a seal so that fluid can not pass the seal in either direction and so that the moveable plug may be ejected from the fluid bag port to eliminate the seal; 20 installing and/or inserting the one or more fluid bag port in a fluid bag to thereby manufacture the fluid bag. In a sixth aspect the invention resides in a method of assembling a fluid bag comprising installing and/or inserting one or more fluid bag port of the first aspect into a fluid bag.

4 In a seventh aspect the invention resides in a method of using a fluid bag to access fluid stored in the bag, the method including the step of pressing a moveable plug through a fluid bag opening of a fluid bag port, the fluid bag port comprised within or to be added to the fluid bag to thereby use 5 the fluid bag to access the fluid. In an eighth aspect the invention resides in a kit comprising the fluid bag of the second or third aspects and a probe for dislodging the moveable plug. The probe may comprise a slot adjacent a probe tip. 10 The moveable plug according to any above aspect may be positioned by an interference fit within the fluid bag port. The moveable plug according to any above aspect may comprise one or more recess or protrusion. When the moveable plug comprises one or more recess or protrusion 15 the moveable plug may be positioned by engaging with one or more corresponding protrusion or recess comprised within the fluid bag port. The moveable plug according to any above aspect may comprise a head and/or stem. The head may be wider than stem. 20 The head may be wider than a channel of the fluid bag port. The stem may comprise a constant thickness. The stem may comprise a taper. The head may be rounded. The head may be flat.

5 The moveable plug according to any of the above aspects may comprise a flange. The flange may extend at a right angle to the stem. The flange may be angled to the stem. 5 The moveable plug according to any above aspect may comprise a slot. The port of any of the above aspects may be tapered. The port of any of the above aspects may comprise a cap. The cap may be joined to the port adjacent an external opening of the 10 port. The cap may be joined to the port by a strap. The cap may seal an external opening of the port. The cap may comprise a tab. The tab may be located on the cap opposite the strap. 15 The cap may comprise one or more cap projection which aligns with corresponding one or more port projections when the cap is fitted. The cap projections may be interposed between and adjacent the strap and the tab. The moveable plug according to any above aspect may be sterile. 20 The moveable plug according to any above aspect may be a sphere, a cube, a cone, a pyramid or screw-shaped. The moveable plug according to any above aspect may be a ball bearing. The moveable plug according to any above aspect may be screw- 6 shaped. The fluid port according to any above aspect may further comprise a port seal membrane upon which the moveable plug is positioned. The port seal membrane may be located over the fluid bag opening. 5 The port seal membrane may be located adjacent or a distance from the fluid bag opening. According to any above aspect a probe for dislodging the moveable plug may also be comprised. The probe may comprise a slot adjacent a probe tip. 10 According to any above aspect in either direction may mean from an external opening of the fluid bag port to a fluid bag opening of the fluid bag port and from a fluid bag opening of the fluid bag port to an external opening of the fluid bag port. Further features of the present invention will become apparent from 15 the following detailed description. In this specification, the terms "comprises", "comprising" or similar terms are intended to mean a non-exclusive inclusion, such that a method, system or apparatus that comprises a list of elements does not include those elements solely, but may well include other elements not listed. 20 BRIEF DESCRIPTION OF THE DRAWINGS In order that the present invention may be readily understood and put into practical effect, reference will now be made to the accompanying illustrations wherein like reference numerals are used to refer to like elements and wherein: 7 FIG. 1 is a schematic diagram of a prior art fluid port; FIGS. 2A-2E are schematic diagrams showing a fluid bag port according to different aspects of the invention; FIG. 2F is a schematic diagram showing one embodiment of a moveable 5 plug according to the invention; FIGS. 3A -3D are schematic diagrams of a fluid bag according to one aspect of the invention; and FIGS. 4-7 are flow charts illustrating methods of the invention. DETAILED DESCRIPTION OF THE INVENTION 10 The invention relates, at least in part, to a fluid bag port and a fluid bag comprising a fluid bag port. The present inventor has provided a novel and inventive fluid bag and fluid bag port which eliminates the requirement for a sharp needle which is present with conventional fluid bags. There are many advantages associated with the inventors' fluid bag port including 15 eliminating the risk of needle-stick injury and eliminating the cost and hassle associated with sharps disposal. A prior art fluid bag port 100 is shown in FIG. 1. To access the fluid stored in a fluid bag (not shown) a needle is inserted into port 100 to penetrate seal 102 which gives access to the fluid. 20 These prior art fluid bags 100 expose a user to a sharp needle and the risk of needle-stick injury. Additionally, because a sharp needle is required so are sharps disposal units and the associated cost and hassle of disposal. The present inventor has provided a fluid bag port and fluid bag which 8 eliminates the requirement for a needle and thereby eliminates any risk of needle-stick injury. The present invention is of significant commercial importance because elimination of the sharp needle also eliminates the cost and difficulty encountered in dealing with sharps. 5 The present invention is also of significant advantage to laboratory staff because the stresses and risks associated with using needles are eliminated. One embodiment of the fluid bag port 200 of the invention is shown in FIG. 2A. Fluid bag port 200 comprises a body 202 comprising a tube 204 10 having an external opening 206 and a fluid bag opening 208. External opening 206 opens to the exterior of port 200 while fluid bag opening 208 opens at an end of port 200 that is to be inserted or is inserted in a fluid bag. Tube 204 comprises a wall 205 and defines a channel 210 in which a moveable plug 214 is may be positioned or located. By positioned or located 15 is meant wholly or at least partially positioned or located in or over channel 210. As shown in FIG. 2A, moveable plug 214 is inserted in fluid bag opening 208. In the embodiment shown in FIG. 2A, moveable plug 214 is prevented from passing through fluid bag opening 208 by an interference fit 20 with the tube 204. When positioned in fluid bag port 200, moveable plug 214 may form a seal so that fluid can not bypass plug 214, i.e. plug 214 prevents fluid from passing from external opening 206 to fluid bag opening 208 or from fluid bag opening 208 to external opening 206.

9 As will be explained below, with reference to FIGS. 3A-3D, to break the seal a probe 400, or similar device, may be used to push plug 214 through port 200 to dislodge plug 214 and allow fluid to pass through port 200. 5 In another embodiment, instead of, or in addition to the interference fit, moveable plug 214 may comprise one or more recess (not shown) or protrusion (not shown) for engaging with one or more recess (not shown) or protrusion (not shown) comprised on tube 204. These complementary plug recess or protrusion and tube protrusion or recess may mate with each other. 10 FIG. 2B shows an embodiment in which tube 204 is tapered so that moveable plug 214 is secured and positioned within tube 214 by virtue of the taper. Suitably the taper is from a wider external opening 206 to a relatively less wide fluid bag opening 208. According to this embodiment moveable plug 214 may be inserted in tube 204 through opening 206 and it will travel 15 down tube 204 until it engages in an interference fit with a part of tube 204 at which the taper produces a tube width complimentary to the size of plug 214. In yet another embodiment, shown in FIG. 2C fluid bag port 200 comprises a port seal 212. Port seal 212 may be a plastic membrane. In the embodiment shown in FIG. 2C port seal 212 is positioned or 20 located over fluid bag opening 208. In other embodiments port seal 212 is located adjacent to or a distance from fluid bag opening 208. A skilled person is readily able to select an appropriate position or location for port seal 212 within channel 210. One or more port seal 212 may also be added to the other 10 embodiments described herein, such as those of FIGS. 2A, 2B, 2D and 2E. In FIG. 2D a second moveable plug 214 is shown to be positioned above a first moveable plug 214. The addition of the second moveable plug 214 allows a fluid 213 to be stored in a seal formed between second and first 5 moveable plugs, 214, 214. Fluid 213 may react in some way with a fluid 320 stored in a bag 300 that port 200 is fitted, or is to be fitted to (see FIGS. 3A and 3B), for example fluid 213 may be a preservative, an enzyme and/or a chelator. In the embodiment shown in FIG. 2D, the taper of tube 204 has the 10 result that second moveable plug 214 which has a larger diameter than the first moveable plug 214 is positioned above first moveable plug 214. The diameter of plugs 214 and taper of tube 204 may be chosen to permit storage of a desired volume of fluid 213. In the embodiments shown in FIGS. 2A-2D moveable plug 214 is a 15 ball bearing made out of stainless steel. Based on the guidance herein a skilled person is readily able to select other suitable materials from which to make moveable plug 214 such as, a plastic. In the embodiments shown in FIGS. 2A-2D, the moveable plug 214 is shown to be spherical, however it may be any suitable shape such as, a 20 cube, a rectangle, a cone, a pyramid or like the embodiment shown in FIG. 2E screw-shaped. FIG. 2E shows another embodiment of fluid bag port 200 comprising a moveable plug 214 comprising a head 218 and a stem 216. Head 218 is wider than stem 216 which forms flange 222. Head 218 is also wider than 11 channel 210 to prevent plug 214 wholly entering channel 210. As shown, in FIG. 2E when plug 214 is inserted in port 200, stem 216 penetrates fluid bag opening 208, flange 222 abuts or rests against wall 205 and head 218 remains outside channel 210. That is, unlike plug 214 shown in FIGS. 2A-2D, 5 which is wholly positioned or located in channel 210, plug 214 shown in FIG. 2E is partially positioned or located in channel 210. The moveable plug 214 of FIG. 2E also comprises a slot 220 disposed o and end of stem 216 which may receive a head of a probe 400. Slot 220 may also assist in the turning of plug 214 with probe 400 to assist in 10 dislodging plug 214. Provision of slot 220 may also prevent probe 400 from vacuuming onto plug 214 and also prevent any fluid from passing. In other embodiments moveable plug 214 does not comprise slot 220. While plug 214 of FIG. 2E is screw-shaped, neither plug 214 or port 200 comprise a thread. In other embodiments plug 214 and port 200 15 comprise complementary threads. Port 200 shown in FIG. 2E also comprises a cap 230 joined to tube 204 adjacent external opening 206 by strap 232. Strap 232 is attached to both tube 204 and cap 230. When fitted, cap 230 seals external opening 206. 20 To assist in its removal, cap 230 comprises a tab 234 which may be gripped. Tab 234 is suitably located on cap 230 opposite strap 232. To assist in sealing and identification of proper fitting, cap 230 comprises cap projections 236 which align with port projections 211 when cap 230 is fitted to tube 200. When port projections 211 abut or touch cap 12 projections 236, the proper fitting of cap 230 is indicated. The embodiment of port 200 shown in FIG. 2E comprises two cap projections 236 located on opposite sides of cap 230 and interposed between and adjacent strap 232 and tab 234. Based on the teaching herein 5 a skilled person is readily able to select other suitable numbers of projections 236. FIG. 2F shows a cross-sectional view of the moveable plug 214 shown in FIG. 2E. In the embodiment shown in FIG. 2F, head 218 is rounded. In other embodiments head 218 is flat. 10 FIG. 2F shows flange 222 to extend at a right angle to stem 216. In other embodiments flange 222 is angled to stem 216. Stem 216 is shown to comprise a constant thickness. In another embodiment stem 216 comprises a taper. Suitably the taper is from a thicker flange adjoining end to a thinner opposite end. 15 Preferably moveable plug 214 is made from an inert material. In one embodiment moveable plug is a plastic such as, those described below. Preferably moveable plug 214 is sterilized. Tube 204 is shown to be circular but it may be any suitable shape such as, triangular, square and rectangular. 20 Tube 204 is made of a plastic. Based on the teaching herein a skilled person is readily able to select other suitable materials for tube 204 such as, a metal. Port seal 212 is also made from a plastic. From the teaching herein a skilled person is readily able to select 13 other suitable materials from which to make port seal 212 such as, wax. FIGS. 3A and 3B show fluid bag port 200 shown in FIG. 2A fitted to a fluid bag 300 containing fluid 320. Fluid bag port 300 is a conventional fluid bag such as for example, that used for separating plasma from blood. Fluid 5 bag 300 comprises a plastic shell 302 and contains a fluid 320. In the illustrative embodiment, fluid 320 is blood. To break the seal formed by plug 214 a probe 400 can be inserted into external opening 206 and advanced through channel 210 until probe 400 impacts upon moveable plug 214. Probe 400 is then advanced further into 10 channel 210 until moveable plug 214 is pushed out fluid bag opening 208 and into fluid bag 300. Advantageously, probe 400 comprises a blunt tip 404 which eliminates any risk of needle-stick injury to staff using the invention. Plug 214 is shown to sink to the bottom of bag 300, however in other 15 embodiments plug 214 floats on fluid 320. Probe 400 also comprises and defines a channel 406 through which fluid 320 may be transported. Once plug 214 is expelled, and where present port seal 212 is broken, probe 400 may be used to extract blood 320 from fluid bag 300 through 20 channel 406. In another embodiment an additional device such as, a pipette, may be used to extract blood 320. FIGS. 3C and 3D show another embodiment of fluid bag 300 comprising two of the embodiment of port 200 shown in FIG. 2E located either side of a central port 330.

14 Central port 330 is comprises tube 332 which defines channel 334 through which fluid, such as fluid 320, may flow. Probe 400 is attached at the distal end of tube 332 and may be used to expel one or more plug 214 from corresponding one or more port 200. 5 Plugs 214 are shown fitted to ports 200 in FIG. 3C and expelled from ports 200 in FIG. 3D. Probe 400 comprises a slot 410 adjacent tip 404 which prevents vacuuming onto plug 214 and thereby prevents any fluid from passing. Fluid bag 300 is made of a plastic. 10 Advantageously, fluid bag port 200 may be fitted to most conventional fluid bags available. Probe 400 is made of metal. In other embodiments, probe 400 may be made of other suitable materials such as, a plastic. Plastics used in construction of the invention described herein may 15 include acetal, polypropylene, acrylonitrile butadiene styrene (ABS), polyvinylchloride (PVC), ethylene vinyl acetate (EVA), polyethylene (PE), nylon, other suitable plastics and/or a combination of these. One suitable acetal for use in manufacture of plug 214 is delrin*. The fluid bag port 200 and fluid bag 300 of the invention may be used 20 to contain various fluids such as, blood and plasma. The blood and plasma may be human or animal such as, equine, murine, canine, feline, porcine, bovine and ovine. The blood and plasma may be that of a performance animal such as a horse or greyhound. Fluid bag 300 may be centrifuged to allow separation of phases in 15 fluid 320. The invention also provides a method 400 of manufacturing a fluid bag port 200. The method is shown illustratively in FIG. 4, which shows step 422 of installing and/or inserting a moveable plug 214 in a fluid bag opening 5 208 of a fluid bag port 200 thereby forming a seal so that fluid can not pass from an external opening 206 of the fluid bag port 200 to the fluid bag opening 208 of the fluid bag port 200 and so that the moveable plug 214 may be ejected from the fluid bag port 200 to eliminate the seal. The invention also provides a method 500 of manufacturing a fluid 10 bag 300 which is shown in FIG. 5 to include an additional step 424 of installing and/or inserting fluid bag port 200 in a fluid bag to thereby manufacture the fluid bag 300. As shown in FIG. 6, the inventor has also provided a method 600 for assembling a fluid bag 300 including the step 626 of installing a fluid bag port 15 200 in a fluid bag to thereby assemble fluid bag 300. FIG. 7 shows another method 700 of the invention of using fluid bag 300 to access fluid stored in bag 300. Method 700 includes step 728 of pressing moveable plug 214 through a fluid port 200 comprised within or to be added to a fluid bag to thereby use the fluid bag 300 to access fluid 320. 20 The invention also provides a kit 800 (not shown) comprising fluid bag 300 and probe 400. The kit may also comprise instructions for use. The present claimed invention is of great advantage because not only does it eliminate the risk of needle-stick injury, it also eliminates the cost and bother associated with storage and disposal of used sharps.

16 It is thought that users of the invention will greatly appreciate the advantages of the invention and the elimination of the threat of needle-stick injury will eliminate this worry and stress from their work day. Throughout the specification the aim has been to describe the 5 preferred embodiments of the invention without limiting the invention to any one embodiment or specific collection of features. It will therefore be appreciated by those of skill in the art that, in light of the instant disclosure, various modifications and changes can be made in the particular embodiments exemplified without departing from the scope of the present 10 invention. All computer programs, algorithms, industrial, patent and scientific literature referred to herein is incorporated herein by reference.

Claims (20)

1. A fluid bag port comprising a moveable plug positioned in a fluid bag opening of the fluid bag port and forming a seal so that fluid can not pass the seal in either direction. 5

2. The fluid bag port of claim 1 wherein the port comprises a tube defining a channel wherein the moveable plug is positioned within the channel.

3. A fluid bag comprising the fluid bag port of claim 1 or claim 2.

4. A fluid bag comprising a fluid bag port, the fluid bag port comprising a 10 moveable plug positioned in a fluid bag opening of the fluid bag port and forming a seal so that fluid can not pass the seal in either direction.

5. The fluid bag according to claim 4 wherein the fluid bag port comprises a tube defining a channel to access contents of the fluid bag, wherein the moveable plug is positioned within the channel. 15

6. A method of manufacturing a fluid bag port including the step of: installing and/or inserting a moveable plug in a fluid bag opening of a fluid bag port thereby forming a seal so that fluid can not pass the seal in either direction and so that the moveable plug may be ejected from the fluid bag port to eliminate the seal and to thereby manufacture the fluid bag port. 20

7. A method of manufacturing a fluid bag including the steps of: installing and/or inserting a moveable plug in a fluid bag opening of a fluid bag port thereby forming a seal so that fluid can not pass the seal in either direction and so that the moveable plug may be ejected from the fluid bag port to eliminate the seal; 18 installing and/or inserting the fluid bag port in a fluid bag to thereby manufacture the fluid bag.

8. A method of assembling a fluid bag comprising installing and/or inserting the fluid bag port of claim 1 or claim 2 into a fluid bag. 5

9. A method of using a fluid bag to access fluid stored in the fluid bag, the method including the step of pressing a moveable plug through a fluid bag opening of a fluid bag port comprised within or to be added to the fluid bag to thereby use the fluid bag to access the fluid.

10. A kit comprising the fluid bag of any one of claims 3 to 5 and a probe 10 for dislodging the moveable plug.

11. A fluid bag port according to claim 1 or claim 2, a fluid bag according to any one of claims 3 to 5, a method according to any one of claims 6 to 9 or a kit according to claim 10 wherein the moveable plug is positioned by an interference fit within the fluid bag port. 15

12. A fluid bag port according to claim 1 or claim 2, a fluid bag according to any one of claims 3 to 5, a method according to any one of claims 6 to 9 or a kit according to claim 10 wherein the moveable plug is sterile.

13. A fluid bag port according to claim 1 or claim 2, a fluid bag according to any one of claims 3 to 5, a method according to any one of claims 6 to 9 20 or a kit according to claim 10 wherein the moveable plug comprises a sphere, a cube, a cone, a pyramid or a screw shape.

14. A fluid bag port according to claim 1 or claim 2, a fluid bag according to any one of claims 3 to 5, a method according to any one of claims 6 to 9 or a kit according to claim 10 wherein the moveable plug comprises a head, 19 a stem and/or a flange.

15. A fluid bag port according to claim 1 or claim 2, a fluid bag according to any one of claims 3 to 5, a method according to any one of claims 6 to 9 or a kit according to claim 10 wherein the moveable plug comprises a slot. 5

16. A fluid bag port according to claim 1 or claim 2, a fluid bag according to any one of claims 3 to 5, a method according to any one of claims 6 to 9 or a kit according to claim 10 wherein the fluid bag port comprises a cap for sealing an external opening of the port.

17. A fluid bag port according to claim 1 or claim 2, a fluid bag according 10 to any one of claims 3 to 5, a method according to any one of claims 6 to 9 or a kit according to claim 10 wherein the fluid bag port comprises a head, a stem and a flange.

18. A fluid bag port according to claim 1 or claim 2, a fluid bag according to any one of claims 3 to 5, a method according to any one of claims 6 to 9, 15 or a kit according claim 10 wherein in either direction comprises from an external opening of the fluid bag port to a fluid bag opening of the fluid bag port; and from a fluid bag opening of the fluid bag port to an external opening of the fluid bag port.

19. A fluid bag port, a fluid bag or a kit substantially as herein described or 20 substantially as herein described with reference to the accompanying drawings.

20. A method of manufacturing a fluid bag port, a method of manufacturing a fluid bag, a method of assembling a fluid bag or a method of using a fluid bag to access fluid stored in the bag substantially as herein 20 described or substantially as herein described with reference to the accompanying drawings.