Abstract
Liquid transfer devices based on commonly owned WIPO International Publication No. WO 2007/052252 entitled Needleless Additive Control Valve. The liquid transfer devices include either an integral vial adapter and/or an integral infusion set for reducing cost and facilitating use by reducing user steps.
Claims
1. A liquid transfer device configured for use with each of an infusion liquid container containing an infusion liquid and having an intravenous (IV) port for administering the infusion liquid, a vial including a vial bottle sealed by a vial stopper and containing a medicament additive, and an infusion set including an IV spike for sealing insertion into an IV port and a connector for administration purposes to a patient, the liquid transfer device comprising: i) an integral trifurcated connector body; ii) a single IV spike defining a first end of the integral trifurcated connector body for sealing insertion into the infusion liquid container's IV port, iii) an integral vial adapter extending from a second end of the integral trifurcated connector body for telescopically mounting on the vial, said integral vial adapter including a puncturing cannula for puncturing the vial stopper upon said mounting of said vial adapter onto the vial for flow communication therewith, and iv) an administration port extending from a third end of the integral trifurcated connector body and constituted by a substitute IV port for sealingly receiving the infusion set's IV spike, the integral trifurcated connector body connecting said single IV spike in direct and continuous fluid communication with said integral vial adapter and connecting said single IV spike in direct and continuous fluid communication with said administration port, thereby enabling initial introduction of the medicament additive from the vial to the infusion liquid container through the vial adapter and the single IV spike for mixing with the infusion liquid to form a medicated infusion liquid, and subsequent administration of the medicated infusion liquid to a patient from the infusion liquid container through the single IV spike and the administration port to the infusion set.
Description
BRIEF DESCRIPTION OF DRAWINGS
(1) In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:
(2) FIG. 1 is a pictorial view of a conventional administration set including an infusion liquid bag, aforementioned WO 2007/052252 needleless additive control valve, a pre-filled syringe, a male vial adapter, a vial, and an infusion set;
(3) FIG. 2A is a front view of the FIG. 1 needleless additive control valve with a self-sealing access valve;
(4) FIG. 2B is a front view of the self-sealing access valve;
(5) FIG. 3A is a cross section of the self-sealing access valve in its closed condition along line A-A in FIG. 2A;
(6) FIG. 3B is a cross section of the self-sealing access valve in its closed condition along line A-A in FIG. 2A;
(7) FIG. 4 is a pictorial view of an administration set including an infusion liquid bag, a liquid transfer device in accordance with a first preferred embodiment of the present invention, a vial and an infusion set;
(8) FIG. 5A is a top view of FIG. 4's liquid transfer device;
(9) FIG. 5B is a longitudinal cross section of FIG. 4's liquid transfer device along line A-A in FIG. 5A;
(10) FIG. 6 is a pictorial view of an administration set including an infusion liquid bag, a liquid transfer device in accordance with a second preferred embodiment of the present invention, and a vial; and
(11) FIG. 7 is a pictorial view of an administration set including an infusion liquid bag, a liquid transfer device in accordance with a third preferred embodiment of the present invention, a pre-filled syringe, a vial adapter, and a vial.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
(12) FIGS. 1, 2A, 2B, 3A and 3B correspond with aforementioned WO 2007/052252's FIGS. 1, 2A, 2B, 3A and 3B, respectively.
(13) FIG. 1 shows an infusion liquid bag 10 containing an infusion liquid and having an intravenous (IV) or administration port 11 and an additive port 12. FIG. 1 also shows an aforementioned WO 2007/052252 needleless additive control valve 13 and an additive transfer device 14 having a male Luer lock connector 16. The additive transfer device 14 can be constituted by a syringe 17, a vial adapter 18 for snap fit telescopic mounting onto a vial 19, and the like. The syringe 17 is pre-filled with a medicament liquid for injection either into the infusion liquid bag 10 for mixing with the infusion liquid to form a medicated infusion liquid for administration to a patient or direct administration to a patient. The vial 19 includes a vial bottle 20A sealed by a vial stopper 20B. The vial 19 contains vial contents in the form of a medicament liquid additive or a lyophilized powder drug requiring reconstitution prior to administration. The vial contents are intended to be introduced into the infusion liquid bag 10 for mixing with the infusion liquid to form a medicated infusion liquid for administration to a patient.
(14) FIG. 1 additionally shows a conventional infusion set 50 with an IV spike 51 for sealed insertion into the IV port 11. The infusion set 50 additionally includes first tubing 52, a clamp 53, a drip chamber 54, second tubing 56, a roller clamp 57, a male Luer connector 58, and a Luer shield 59. First tubing 52 typically has dimensions 4.1 mm200 mm and second tubing 56 typically has dimensions 4.1 mm and 500 mm.
(15) FIG. 2A shows the aforementioned WO 2007/052252 needleless additive control valve 13 has a trifurcated connector body 21. The trifurcated connector body 21 includes an IV spike 22 for sealing insertion into the IV port 11. The IV spike 22 is formed from suitable rigid plastic material such as polycarbonate, and the like. The IV spike 22 includes a spiked end 23 with peripherally disposed apertures 24, a lumen 26, and an outlet aperture 27. The IV spike 22 is integrally formed as an injection molded monolithic structure with a circular flange 28 for restricting insertion into the IV port 11 and a normally closed (NC) needleless additive port 29 disposed toward the outlet aperture 27.
(16) The needleless additive port 29 has a lumen 31 and is fitted with a self-sealing access valve 32 for screw threadingly receiving a male Luer lock connector 16. The access valve 32 has a stepped exterior surface 33 including an abutment surface 34 and a rim 36. The access valve 32 houses a silicone self-sealing valve member 37 with a tubular main portion 38 and a cylindrical needleless entry portion 39. The needleless entry portion 39 has an exposed entry surface 41 and a pre-formed slit 42 extending therealong (see FIG. 2B).
(17) The valve member 37 has a natural length L1 and is so dimensioned that the entry surface 41 is flush with the rim 36 thereby enabling the entry surface 41 to be readily swabbed for sterilization purposes (see FIG. 3A). A male Luer connector 16 screw threaded onto the access valve 32 advances until it abuts against the abutment surface 34. During its advancement, the male Luer connector 16 compresses the valve member 37 to a compressed length L2<L1 which parts the entry portion 39 along its pre-formed slit 42 for enabling fluid communication between an additive transfer device and the lumen 31 (see FIG. 3B).
(18) The trifurcated connector body 21 includes an administration port 43 constituted by a substitute IV port having a lumen 44 and a sealing membrane 46. The lumen 44 is in continuous flow communication with the outlet port 27. The substitute IV port 43 is a conventional IV port similar to the IV port 11 made from suitable flexible plastic material, for example, PVC, and the like, for sealingly receiving an about 5 mm to 6 mm diameter IV spike. The substitute IV port 43 is intended to sealingly receive the IV spike 51.
(19) FIG. 4 shows an administration set 100 including an infusion liquid bag 10, a liquid transfer device 101, a vial 19, and an infusion set 50. The liquid transfer device 101 is similar in construction to the needleless additive control valve 13 and accordingly includes an IV spike 22, a needleless additive port 29 and an administration port 43. The liquid transfer device 101 differs from the needleless additive control valve 13 insofar as the needleless additive port 29 is constituted by an integral vial adapter 102. The latter 101 also includes a shield 103 protecting the IV spike 22.
(20) FIGS. 5A and 5B show the integral vial adapter 102 has a conventional design including a skirt 104 for snap fit mounting on a vial 19 and a puncturing member 106 for puncturing its vial stopper 20B for fluid communication with a vial interior on snap fitting the integral vial adapter 102 on a vial 19. The puncturing member 106 is in direct and continuous fluid communication with the IV spike 22 and the substitute IV port 43.
(21) The use of the administration kit 100 is as follows: The IV spike 22 is sealingly inserted into IV port 11 and the vial adapter 102 is snap fitted on a vial 19 for adding its medicament additive to the infusion liquid bag 10. Such adding is typically achieved by squeezing the infusion liquid bag 10 to urge infusion liquid into the vial 19 and then inverting the infusion liquid bag 10 such that the vial contents drain thereinto. In the case the vial 19 includes a lyophilized medicament additive, the infusion liquid dissolves same. Such dissolving may require several cycles of urging infusion liquid into the vial 19 and draining vial contents to the infusion bag 10. Thereafter, the IV spike 51 is sealingly inserted into the liquid transfer device's substitute IV port 43 for administration purposes to a patient.
(22) FIG. 6 shows an administration set 110 including an infusion liquid bag 10, a liquid transfer device 111, and a vial 19. The liquid transfer device 111 is similar in construction to the liquid transfer device 101 and accordingly includes an IV spike 22, a needleless additive port 29 and an administration port 43. The liquid transfer device 111 differs from the liquid transfer device 101 insofar as the latter 111 includes an administration port 43 constituted by an integral infusion set 122 instead of a substitute IV port. The integral infusion set 112 is similar to the infusion set 50 except that the first tubing 52 is directly connected to the connector body 21.
(23) The use of the liquid transfer device 111 is similar to the use of the liquid transfer device 101 in terms of adding medicament additive to the infusion liquid bag 10.
(24) FIG. 7 shows an administration set 120 including an infusion liquid bag 10, an additive transfer device 14 and a liquid transfer device 121. The liquid transfer device 121 is similar in construction to the needleless additive control valve 13 and accordingly includes an IV spike 22, a needleless additive port 29 and an administration port 43. The liquid transfer device 121 differs from the needleless additive control valve 13 insofar as the latter 121 includes an administration port 43 constituted by an integral infusion set 122 instead of a substitute IV port. The use of liquid transfer device 121 is similar to the aforementioned WO 2007/052252 needleless additive control device 13 except that its infusion set 122 can be directly connected to a patient.
(25) While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.
