Liquid transfer device with integral telescopic vial adapter for use with infusion liquid container and discrete injection vial
11786443 ยท 2023-10-17
Assignee
Inventors
Cpc classification
A61J1/2089
HUMAN NECESSITIES
A61J1/2096
HUMAN NECESSITIES
International classification
Abstract
Liquid transfer devices with an integral telescopic vial adapter for use with an infusion liquid container and an initially non-punctured intact discrete injection vial. The integral telescopic vial adapter is configured for initial telescopic snap mounting on a discrete injection vial leaving its injection vial stopper non-punctured until a subsequent compaction for puncturing the injection vial stopper. The integral telescopic vial adapter includes a safety catch mechanism for precluding advertent compaction from a pre-compacted state to a compacted state. The integral telescopic vial adapter includes a clamping arrangement for irreversibly clamping same in its final compacted state.
Claims
1. A liquid transfer device configured to releasably connect to an injection vial comprising a vial tube containing a medicament and an opening defined by a vial crown that is closed by a non-punctured injection vial stopper, the liquid transfer device comprising an integral telescopic vial adapter having a longitudinal vial adapter centerline and comprising: an inner vial adapter body comprising an annular inner vial adapter body wall transverse to the longitudinal vial adapter centerline and a longitudinally extending vial crown sleeve terminating in a vial crown sleeve rim; an outer vial adapter body comprising an outer vial adapter body wall transverse to the longitudinal vial adapter centerline and a longitudinally extending skirt, the outer vial adapter body telescopically receiving the inner vial adapter body therein, wherein the integral telescopic vial adapter is configured to be transitioned from a pre-compacted state with an initial distance between the outer vial adapter body wall and the vial crown sleeve rim to a compacted state with a final distance between the outer vial adapter body wall and the vial crown sleeve rim that is less than the initial distance, and wherein the outer vial adapter body comprises a puncturing cannula configured to puncture the injection vial stopper to enable fluid communication with the medicament contained in the vial tube; a safety catch mechanism for selectively preventing compaction of the integral telescopic vial adapter from the pre-compacted state to the compacted state; and a clamping arrangement for irreversibly clamping the integral telescopic vial adapter in the compacted state.
2. The liquid transfer device of claim 1, wherein the safety catch mechanism comprises a twist release safety catch mechanism comprising: a diametric pair of L-shaped tracks in the outer vial adapter body, each L-shaped track having a major track leg a minor track leg, a start track end adjacent the longitudinally extending skirt and a finish track end adjacent the outer vial adapter body wall; and a diametric pair of radial outward projections on the inner vial adapter body for travelling along the diametric pair of L-shaped tracks from the start track end in the pre-compacted state to the finish track end in the compacted state.
3. The liquid transfer device of claim 2, wherein each finish track end includes a one-way passage arrangement for irreversibly clamping the integral telescopic vial adapter to the injection vial in the compacted state.
4. The liquid transfer device of claim 2, wherein the inner vial adapter body has a diametric pair of radial outward finger grips the outer vial adapter body has a diametric pair of anti-slip surfaces orthogonal to the diametric pair of radial outward finger grips in the pre-compacted state.
5. The liquid transfer device of claim 1, wherein the safety catch mechanism comprises a pull release safety catch mechanism such that extension of the inner vial adapter body with respect to the outer vial adapter body co-directional with the longitudinal vial adapter centerline releases the safety catch mechanism for enabling compaction of the integral telescopic vial adapter from the pre-compacted state to the compacted state.
6. The liquid transfer device of claim 1, wherein the safety catch mechanism comprises a safety catch extending through the outer vial adapter body in the pre-compacted state to prevent compaction of the integral telescopic vial adapter from the pre-compacted state to the compacted state.
7. The liquid transfer device of claim 1, wherein: the vial crown sleeve includes a major vial crown sleeve surround and a diametric pair of injection vial crown holding members pivotal with respect thereto, each of the vial crown holding members has a proximal vial crown holding member section and a distal vial crown holding member section, each distal vial crown holding member section has a radially inward vial crown holding projection towards the vial crown sleeve rim for snap fitting under the vial crown, and each proximal vial crown holding member section is pivotal with respect to the major vial crown sleeve surround such that compression on the diametric pair of proximal vial crown holding member sections moves the diametric pair of radial inward vial crown holding projections radially outward to release the non-punctured injection vial from the inner vial adapter body.
8. The liquid transfer device of claim 7, wherein the longitudinally extending skirt includes a diametric pair of through holes for providing access to the diametric pair of vial crown holding members.
9. The liquid transfer device of claim 7, wherein the diametric pair of vial crown holding members pivot on annular inner vial adapter body wall.
10. A kit comprising: the liquid transfer device of claim 1; and a vial release tool configured to release the non-punctured injection vial from the inner vial adapter body.
11. The kit of claim 10, wherein the vial release tool comprises a pair of opposing jaws, each jaw comprising an inward directed protrusion.
12. The kit of claim 11, wherein the vial release tool is configured to release the non-punctured injection vial from the inner vial adapter body when the inward directed protrusions radially push a diametric pair of vial crown holding projections of the vial crown sleeve.
13. The liquid transfer device of claim 1, wherein the integral telescopic vial adapter is configured to transition from the pre-compacted state to the compacted state in response to rotation of the inner vial adapter body with respect to the outer vial adapter body about the longitudinal vial adapter centerline.
14. The liquid transfer device of claim 13, wherein an initial rotation of the inner vial adapter body with respect to the outer vial adapter body primes the integral telescopic vial adapter from the pre-compacted state to an intermediate primed state, and subsequent rotation of the inner vial adapter body with respect to the outer vial adapter body transitions the integral telescopic vial adapter from the intermediate primed state to the compacted state.
15. The liquid transfer device of claim 2, wherein each major track leg is co-directional with the longitudinal vial adapter centerline and each minor track leg is transverse to the longitudinal vial adapter centerline.
16. The liquid transfer device of claim 6, wherein withdrawal of the safety catch from the outer vial adapter body enables compaction of the integral telescopic vial adapter from the pre-compacted state to the compacted state.
17. The liquid transfer device of claim 7, wherein the compression on the diametric pair of proximal vial crown holding member sections is applied by a vial release tool with an opposite pair of inward directed protrusions for applying pincers-like compression.
18. The liquid transfer device of claim 1, further comprising a trifurcated connector body comprising a liquid transfer device IV spike for sealing insertion into an IV port, a vial adapter port with the integral telescopic vial adapter, and a substitute IV port.
19. The liquid transfer device of claim 18, wherein the liquid transfer device IV spike is in direct and continuous fluid communication with the vial adapter port and the substitute IV port thereby enabling an initial forming of a medicated infusion liquid and a subsequent administration of the medicated infusion liquid.
20. The liquid transfer device of claim 1, wherein a distal tip of the puncturing cannula overlies the non-punctured injection vial stopper in the pre-compacted state and the distal tip of the puncturing cannula punctures through the injection vial stopper in the compacted state.
Description
BRIEF DESCRIPTION OF THE 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:
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
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(27) The infusion set 50 includes an IV spike 51 and additionally includes first tubing 52, a clamp 53, a drip chamber 54, second tubing 56, a roller clamp 57, and a male Luer connector 58.
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(30) The liquid transfer device 100A differs from the liquid transfer device 60 insofar that it includes an integral telescopic vial adapter 101 with a longitudinal vial adapter centerline 101A and having two part construction: an inner vial adapter body 102 and an outer vial adapter body 103. The integral telescopic vial adapter 101 includes a twist release safety catch mechanism 104 for preventing inadvertent user compaction from a pre-compacted state to a compacted state and a clamping arrangement 106 for irreversibly clamping the integral telescopic vial adapter 101 in its compacted state. The integral telescopic vial adapter 101 additionally includes an inverted T-shaped sealing member 107.
(31) The inner vial adapter body 102 has an inverted cup shape including an uppermost transverse annular inner vial adapter body wall 108 and a downward depending vial crown sleeve 109 with a lowermost vial crown sleeve rim 109A. The inner vial adapter body 102 bounds a vial crown cavity 111 for snugly receiving the vial crown 33 therein on telescopically snap fitting the inner vial adapter body 102 thereon. The uppermost transverse annular inner vial adapter body wall 108 has a center uppermost transverse annular inner vial adapter body wall throughgoing aperture 108A along the longitudinal vial adapter centerline 101A overlying the uppermost injection vial surface 41 on telescopically snap fitting on the discrete injection vial 30.
(32) The vial crown sleeve 109 includes a major vial crown sleeve surround 112 with a first adjacent pair of longitudinal directed slits 113A and a second adjacent pair of longitudinal directed slits 113B for correspondingly forming a diametric pair of vial crown holding members 114A and 114B. The diametric pair of vial crown holding members 114 are pivotal with respect to the major vial crown sleeve surround 112 such that each vial crown holding member 114 has a proximal vial crown holding member section 116 and a distal vial crown holding member section 117. The uppermost transverse annular inner vial adapter body wall 108 preferably has a diametric pair of cutouts 118 inward of the diametric pair of vial crown holding members 114 such that the diametric pair of vial crown holding members 114 pivot on the uppermost transverse annular inner vial adapter wall 108.
(33) The distal vial crown holding member sections 117 are each provided with a radial inward vial crown holding projection 119 towards the lowermost vial crown sleeve rim 109A for snap fitting under the vial crown 33 on telescopically snap fitting the inner vial adapter body 102 on the initially non-punctured intact discrete injection vial 30. Application of a pincers-like compression on the proximal vial crown holding member sections 116 towards the longitudinal vial adapter centerline 101A pivots the vial crown holding members 114A and 114B with respect to the major vial crown sleeve surround 112 thereby distancing the radial inward vial crown holding protrusions 117 from the longitudinal vial adapter centerline 101A.
(34) The uppermost transverse annular inner vial adapter body wall 108 has a diametric pair of upright wings 121A and 121B orthogonal to the diametric pair of vial crown holding members 114A and 114B. The diametric pair of upright wings 121 each have a radial outward projection 122 constituting a component of both the twist release safety catch mechanism 104 and the clamping arrangement 106. The vial crown sleeve 109 has a peripheral vial crown sleeve surface 109B with a diametric pair of user indications for indicating a first user step denoted by a circular arrow labelled 1 and a second user step denoted by an upright arrow labelled 2 for activating the liquid transfer device 100A. The vial crown sleeve 109 has a diametric pair of radial outward finger grips 109C towards the lowermost downward depending vial crown sleeve rim 109A.
(35) The outer vial adapter body 103 has an inverted cup shape including an uppermost transverse outer vial adapter body wall 123 and a downward depending skirt 124 with a lowermost skirt rim 124A. The uppermost transverse outer vial adapter body wall 123 is integral mounted on the vial adapter port 64. The outer vial adapter body 103 bounds an inner vial adapter body cavity 126 for snugly telescopically receiving the inner vial adapter body 102 therein on compacting the integral telescopic vial adapter 101 from a pre-compacted state to a compacted state.
(36) The uppermost transverse outer vial adapter body wall 123 includes a downward depending puncturing cannula 127 with a proximal puncturing cannula opening 127A and a distal puncturing cannula tip 127B. The proximal puncturing cannula opening 127A is in flow communication with the vial adapter port 64 and the distal puncturing cannula tip 127B punctures the injection vial stopper 37 in the compacted state of the liquid transfer device 100A.
(37) The downward depending skirt 124 has a diametric pair of L-shaped tracks 128 co-directional with the longitudinal vial adapter centerline 101A constituting a component of both the twist release safety release mechanism 104 and the clamping arrangement 106. The downward depending skirt 124 includes a diametric pair of anti-slip surfaces 129 generally orthogonal to the diametric pair of L-shaped tracks 128 and the diametric pair of radial outward finger grips 109C in the initial pre-compacted state of the liquid transfer device 101A. The downward depending skirt 124 also has a diametric pair of throughgoing discrete injection vial release apertures 131 for use during the release of the discrete injection vial 30. The discrete injection vial release apertures 131 are disposed beneath the anti-slip surfaces 129 and designed to require the pincers-like hand tool 200 to apply a pincers-like compression for releasing a non-punctured intact injection vial 30 and preclude manual application of the pincers-like compression.
(38) Each L-shaped track 128 includes a major track leg 132 co-directional with the longitudinal vial adapter centerline 101A, a minor track leg 133 transverse to the longitudinal vial adapter centerline 101A and a juncture 134 between its major leg 132 and its minor leg 133. Each L-shaped track 128 has a start track end 128A adjacent the lowermost skirt rim 124A and a finish track end 128B adjacent the uppermost transverse outer vial adapter body wall 123. Each minor track leg 133 has a one-way passage arrangement 136 for irreversibly enabling priming of the liquid transfer device 100A. Each finish track end 128B has a one-way passage arrangement 137 constituting a component of the clamping arrangement 106.
(39) The sealing member 107 has a sealing member tube 138 for mounting on the puncturing cannula 127 and a flat sealing member base 139 disposed in the central uppermost transverse annular inner vial adapter body wall throughgoing aperture 108A in the initial pre-compacted state of the liquid transfer device 100A. The central part of the flat sealing member base 139 acts as a sealing member septum 141 for maintaining sterility of the distal puncturing cannula tip 127B. The flat sealing member base 139 is sealing disposed on the uppermost injection vial surface 41 on telescopic mounting the liquid transfer device 100A on the injection vial 30. The sealing member septum 141 is intended to be punctured by the distal puncturing cannula tip 127B in the compacted state of the liquid transfer device 100A.
(40) The use of the liquid transfer device 100A is now described with reference to
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(42) In the event it is decided not to administer the medicament and re-use the non-punctured intact discrete injection vial 30, a healthcare provider takes the following steps as shown in
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(48) While particular embodiments of the present invention are illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention.