Valve with on-off mechanism for bag used for conditioning, reconstituting and/or diluting of injectable products

Abstract

A valve with an on-off mechanism for a bag used for conditioning, reconstituting, and/or diluting of injectable products, with the valve integrated to the single access point of a bag; the valve includes an open-close mechanism that enables a syringe or an infusion equipment, both including a luer-lock terminal, to be directly coupled to said valve; the valve comprises five basic components: the tapered base, the mobile tapered part, a smaller diameter sealing O-ring, a larger diameter sealing O-ring, and the cover that protects the terminal with a luer-lock type thread; the valve removes the requirement of using metallic needles or plastic spikes during practical use of the bag.

Claims

1. A valve for integration with a bag having a single access point and used for conditioning, reconstituting, and/or diluting injectable products, the valve comprising: a tapered base having a channel defined by an inner surface at least part of which is disposed at an angle, the tapered base also having a core disposed inside the channel, the core having an outer portion; a mobile tapered part at least partially disposed inside the tapered base, wherein the mobile tapered part has an outer surface at least part of which is disposed at an angle, the angle of the outer surface of the mobile tapered part being the same as the angle of the inner surface of the tapered base, wherein the mobile tapered part also has a terminal end containing a luer-lock type thread; a first sealing O-ring disposed around the core of the tapered base to seal a space between the core and the mobile tapered part; a second sealing O-ring disposed around the mobile tapered part for sealing a space between the mobile tapered part and the tapered base and to facilitate sliding of the mobile tapered part in relation to the tapered base, the second sealing O-ring having a diameter that is larger than a diameter of the first; and a cover connected to the tapered base which protects the terminal end of the mobile tapered part and prevents detachment of the mobile tapered part from the tapered base.

2. The valve according to claim 1 where the tapered base further comprises a tubular terminal that connects to a small access tube of the single functional access point of the bag, the tubular terminal having an inner channel which terminates in an opening.

3. The valve according to claim 1 where the tapered base further comprises a ring edge to which the cover is attached; the ring edge being seated in a corresponding ring groove provided on the cover.

4. The valve according to claim 1 where the mobile tapered part further comprises a reduced diameter region that integrates an axial channel of the mobile tapered part, where the first diameter sealing O-ring remains in contact with the reduced diameter region when the valve is closed.

5. The valve according to claim 1 where the outer surface of the mobile tapered part is in contact with the inner surface of the tapered base when the valve is closed.

6. The valve according to claim 1 where the tapered base further comprises bas-relief grooves extending along the outer portion of its core.

7. The valve according to claim 4 where the axial channel of the mobile tapered part is defined by an initial portion, a median portion and a larger diameter portion.

8. The valve according to claim 1 where the channel of the tapered base receives a main portion of the mobile tapered part.

9. The valve according to claim 1 where the mobile tapered part further comprises a ring edge which contacts a ring edge on the tapered base whenever the valve is closed.

10. The valve according to claim 1 where the tapered base further comprises liquid flow channels which are defined by radial walls that connect the core to the inner surface of the tapered base.

11. The valve according to claim 1 where the outer surface of the mobile tapered part further comprises radially opposite protrusions which fit into grooves located in the channel of the tapered base.

12. The valve according to claim 1 where the cover further comprises a tube portion defined by an inner surface, the inner surface having a ring groove in which a ring edge on the tapered base is fitted for the purpose of fastening the cover to the tapered base, the inner surface of the tube portion having a reduced diameter region which delimits the motion extension of the mobile tapered part and prevents detachment from the valve.

13. The valve according to claim 1 where the cover further comprises a tube portion and a cover portion, the tube portion further comprising an inner surface and the cover portion further comprising a radial flap for gripping the cover portion, wherein the cover portion is connected to the tube portion via a foldable flap with a deep V-shaped crease, and wherein the inner surface of the tube portion has a reduced diameter region delimiting a circular opening which is further delimited by a tapered truncated edge to which a plastic protrusion on the cover is pressure attached, ensuring full sealing of the cover.

14. The valve according to claim 1 where a syringe with a luer-lock terminal is coupled to the valve by connecting the luer-lock terminal of the syringe to the luer-lock type thread on the terminal end of the mobile tapered part.

15. The valve according to claim 1 where an infusion equipment with a luer-lock terminal is coupled to the valve by connecting the luer-lock terminal of the infusion equipment to the luer-lock type thread on the terminal end of the mobile tapered part.

16. The valve according to claim 1 where the valve is opened or closed by sliding the tapered base in relation to the mobile tapered part, with the opening and closure of the valve being attained by the manual action of driving and pushing a syringe attached to it.

17. The valve according to claim 1 where the valve is opened or closed by sliding the tapered base in relation to the mobile tapered part, with the opening and closure of the valve being attained by the manual action of driving and pushing an infusion equipment attached to it.

18. The valve according to claim 1 where the cover further comprises an outer wall having an embossed area, wherein vertical movements determine the opening or closure of the valve, with the opening of the valve corresponding to downward movement and closure of the valve corresponding to upward movement.

19. The valve according to claim 14 where the syringe is coupled to the valve by rotating the syringe in a clockwise movement, and where the syringe is disconnected from the valve by rotating the syringe in a counter-clockwise movement.

20. The valve according to claim 15, where the infusion equipment is coupled to the valve by rotating the infusion equipment in a clockwise movement, and wherein the infusion equipment is disconnected from the valve by rotating the infusion equipment in a counter-clockwise movement.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The “VALVE WITH ON-OFF MECHANISM FOR BAG USED FOR CONDITIONING. RECONSTITUTING AND/OR DILUTING OF INJECTABLE PRODUCTS”, object is the present invention patent application, is described in detail by the figures below:

(2) FIG. 1 shows a perspective view of the valve, prior to attachment to the bag.

(3) FIG. 2 shows a view indicated by arrow “A” of FIG. 1.

(4) FIG. 3 shows a view indicated by arrow “B” of FIG. 1.

(5) FIG. 4 shows a view outlined by the cut line “A”-“A” of FIG. 3.

(6) FIG. 5 shows an expanded detail of the components that enable the open-close motion of the valve in its fully closed position.

(7) FIG. 5A shows an expanded detail of the components that enable the open-close motion of the valve in its fully opened position.

(8) FIG. 6 shows a view from the tapered base of the valve which will be coupled to the small access tube of the bag.

(9) FIG. 7 shows a view indicated by arrow “C” of FIG. 6.

(10) FIG. 8 shows a view indicated by arrow “D” of FIG. 6.

(11) FIG. 9 shows a view outlined by the cut line “B”-“B” of FIG. 8.

(12) FIG. 10 shows a view from a mobile tapered part with its luer-lock terminal.

(13) FIG. 11 shows a view indicated by arrow “E” of FIG. 10.

(14) FIG. 12 shows a view indicated by arrow “F” of FIG. 10.

(15) FIG. 13 shows a view outlined by the cut line “C”-“C” of FIG. 12.

(16) FIG. 14 shows a view of the cover that protects the luer-lock terminal and also prevents that the mobile part gets detached from the valve.

(17) FIG. 15 shows a view indicated by arrow “G” of FIG. 14.

(18) FIG. 16 shows a view indicated by arrow “H” of FIG. 14.

(19) FIG. 17 shows a view indicated by arrow “I” of FIG. 14.

(20) FIG. 18 shows a view outlined by the cut line “D”-“D” of FIG. 15.

(21) FIG. 19 shows the valve already attached to the bag.

(22) FIG. 20 shows a syringe with a luer-lock terminal attached to the valve.

(23) FIG. 21 shows a syringe with needle (indicating the needle is removed afterwards); a syringe with a luer-lock terminal to access the valve; the syringe itself, with a luer-lock terminal, attached to the valve.

(24) FIG. 22 shows a standard infusion equipment, including a spike (plastic needle) (indicating said spike is removed afterwards); an infusion equipment with a luer-lock terminal (especially designed for use with the valve, object of the present patent application); the infusion equipment with a luer-lock terminal attached to the valve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(25) The “VALVE WITH ON-OFF MECHANISM FOR BAG USED FOR CONDITIONING. RECONSTITUTING AND/OR DILUTING OF INJECTABLE PRODUCTS”, object of the present invention patent application, hereinafter simply referred to as valve, comprises: two tapered plastic parts attachable to each other; two rubber sealing O-rings, one of said rings having a larger diameter which, in addition to helping with side sealing, provides easier sliding between the parts, and a smaller diameter ring which seals the lower section of the valve, preventing liquid flow when the valve is closed; a plastic cover that protects the luer-lock terminal of the mobile tapered part and also prevents detachment of the mobile tapered part from the valve. All materials used in the structure of the valve are suitable for medical and pharmaceutical applications.

(26) Below are featured the details of the valve, object of this patent application, in reference to the aforementioned figures:

(27) FIG. 19: Valve 3 must be attached to the small access tube 6 of the bag 1 which ends up with a single functional access point 2. This access point functions as an entry or exit point. Valve 3 includes a tapered base 4 which is narrowed, defining a 5 to connect with the small access tube 6 of the bag 1. The tubular terminal 5 features the inner channel 35 that ends in an opening 36.

(28) FIG. 6: A mobile tapered part 7 is inserted in the tapered base 4 (as seen in FIG. 10), with terminal 9 including a luer-lock type thread 8.

(29) FIG. 4: A cover 10 is modeled to the end part 11 of the tapered base 4 to protect the luer-lock terminal of the mobile tapered part 7 and also prevent detachment of said part from the valve 3.

(30) Valve 3 includes two sealing O-rings: a larger diameter ring 12 is mounted to the lower groove 14 of the mobile tapered part 7; said sealing ring 12, in addition to sealing, provides easier sliding of the mobile tapered part 7. A smaller diameter sealing O-ring 13 is mounted to the lower part of the core 16 of the tapered base 4; said sealing ring 13 provides sealing of the lower surface and prevents liquid from flowing out of the bag when the valve 3 is closed. When valve 3 is fully closed, the sealing ring 13 remains in contact with the diameter reduction region 17 that constitutes the axial channel 18 of the tapered part 7.

(31) FIG. 5: The mobile tapered part 7, as the name implies, is slightly tapered as demonstrated by its surface 22 which contacts the inner surface 27 of the tapered base 4; “x” indicates the slight angle between the tapered parts; the core 16 of the tapered base 4 features bas-relief grooves 30 extended along the respective section 31, which is fully inserted in the median portion 32 of the axial channel 18, which comprises an initial portion 33, the aforementioned median portion 32 and a larger diameter portion 34. The tapered base 4 includes the housing 19 which receives the main portion 20 (as seen in FIG. 10) of the mobile part 7. The mobile part 7 features a ring edge 26 which is in contact with the ring edge 25 of the tapered base 4, whenever the valve 3 is closed.

(32) FIG. 5A: There are four small liquid flow channels 24 at the lower part of the tapered base 4; the liquid flow through the valve 3 is indicated by the flow arrows SF. The liquid flow channels 24 are formed between radial walls 23 that connect the core 16 to the inner structure of the tapered base 4.

(33) Movement between both tapered parts of the valve 3 takes place without side liquid leakage, due to the conicity and the larger diameter sealing ring 12, which maintains permanent contact with the housing 19 wall of the 4 and the mobile tapered part 7. The arrow Y indicates the relative movement between the mobile tapered part 7 and the tapered base 4.

(34) FIG. 9: The lower part 11 of the tapered base 4 includes a ring edge 25 which is an attachment point for the cover 10 that protects the valve 3, as seen below. There are two attachment grooves 29 (one is seen herein) explained below.

(35) FIG. 10: The mobile tapered part 7 includes two radially opposite protrusions 28 (only one of them is seen in this figure) which are coupled to both grooves 29 mentioned in the description of FIG. 9. Said couplings prevent the rotation between the parts 4 and 7 when a luer-lock syringe S or luer-lock infusion equipment (EI) is attached or detached from the valve 3.

(36) FIG. 18: The plastic cover 10 includes a tube portion 37 which has, in its inner surface, a ring groove 41 in which the ring edge 25 is attached to the tapered base 4, in order to fasten the plastic cover 10 to the tapered base 4; the tube portion 37 also features, in its inner surface, a reduction in diameter 43 which delimitates the motion extension of the mobile tapered part 7 and prevents disconnection from the valve 3. Said motion extension, adjusted in order to enable valve opening or closure of the valve, is illustrated by arrow J.

(37) The plastic cover 10 includes a flap with a deep V-shaped crease 40 which transforms it into a foldable flap 39; said foldable flap 39 is placed between the tube portion 37 and the cover portion 38; the inner tube wall 42 of the plastic cover 10, on its upper part, has a reduction in diameter 43, delimiting a circular opening 45 which, in turn, is delimited by a tapered truncated edge 44, to which the plastic protrusion 46 is pressure attached, ensuring full sealing of the cover 10. The cover 10 is opened or closed using its radial flap 47 as a grip point.

(38) The double arrow 51, inserted as an embossed area 50 on the wall 49, guides opening (downward indication) and closure (upward indication) motions of the valve 3.

(39) FIG. 20: When the cover 10 is opened, a syringe S (see FIG. 21 in which the metallic needle is removed), with a luer-lock terminal, may be attached to terminal 9 including a luer-lock thread 8 of the valve 3, through a clockwise rotating movement; driving the syringe S opens the valve 3; opposite movement closes the valve and detaches the syringe. It is, therefore, through syringe S (without the needle) directly coupled to valve 3 by the luer-lock terminal 8-9 that the contents of the bag 1 are accessed.

(40) FIG. 21: A syringe S with a metallic needle (indicating the needle will be removed) is also shown; syringe S with a luer-lock terminal 8-9 to be attached t valve 3; the syringe attached to the valve 3.

(41) FIG. 22: When the cover 10 is opened, an infusion equipment EI with a luer-lock terminal (equipment especially designed for use with the valve 3, object of this patent application), may be attached to terminal 9 with a luer-lock thread 8 of the valve 3 through a clockwise rotating movement; driving the equipment EI opens the valve 3; opposite movement closes valve 3e and disconnects the equipment EI.

(42) FIG. 22: Further shows a standard infusion equipment (EIT), including a spike (plastic needle) (indicating said spike will be removed); the infusion equipment EI with a luer-lock terminal (equipment especially designed for use with the valve 3, object of the present patent application) to be attached to valve 3; the equipment EI with a luer-lock terminal attached to the valve 3.

(43) The valve 3, arising out of the improvement of the mechanism described in our previous patent PI 1003460-9, has been submitted to comprehensive testing. Said valve may be submitted to sterilization by gamma radiation, ethylene oxide or hot steam; when closed, withstands compression up to 2 BAR, with no leaks (thus significantly beyond current specifications, which provide that bags are leak tested for compression of 0.5 BAR). Valve 3 was also submitted to countless opening and closure cycles, with no leaks, which attests safe usage in injectable product preparation stations and during intravenous infusions.

(44) As it is mounted on a plastic bag, with no pierceable membranes, does not generate coring (particle release due to perforation), therefore being characterized as a proper “No Coring Bag” (no particle generation).

(45) Another groundbreaking feature is that said valve provides full safety when handling the bag: access to the contents is done with a luer-lock syringe (no metallic needle) and/or infusion equipment without spike (plastic needle), needles and spikes usually cause puncturing accidents, as well as increasing the likelihood of contamination. One must only observe a daily hospital routine in order to understand the puncturing accident and contamination hazards when, for example, equipment with spike is detached from a bag and must be re-attached to another bag, a situation that takes place hundreds of times in any hospital, every day. These unsafe procedures are rectified by our valve 3. With said valve 3, universal use of the infusion equipment with luer-lock terminal EI (equipment especially designed for use with the valve 3, object of said patent application) is now possible, which will be provided, also in an innovative character, with the new bag featuring our valve 3.

(46) With the inclusion of rings 12 and 13 and measurement adaptations between components, since said valve was fully upgraded in laboratory, the use of sealing systems was no longer required, as provided in our previous patent (PI 1003460-9), for the first opening of the valve, provided that the cover was also adjusted to ensure full sealing.

(47) It should be highlighted that, although the bag 1 shown in FIGS. 19, 20, 21 and 22 shows a filling port PE, said port may or may not be provided, depending on the packaging technique used for the bag 1: for example, the bag 1 may be packaged and the valve 3 may be placed afterwards on the same port (in this case, the aforementioned filling port PE is not required); in addition, firstly the valve 3 may be molded to the bag 1 and packaging is done through said filling port PE, defined by a small access tube 6, which is to be permanently closed by a bung 48 after the packaging of the bag 1. Therefore, the bag 1 assembled with the valve 3, object of this patent application, will always be a functional single-entry bag (for addition or extraction of liquid through the same entry or exit point).