Liquid transfer device with integral telescoping vial adapter for use with infusion containers and separate injection vials
By designing an integrated telescopic vial adapter and safety locking mechanism, the problem of inconvenient operation of liquid transfer devices has been solved, enabling convenient preparation and timely application of drug infusion solutions and reducing drug waste.
Patent Information
- Application Number
- CN202210337592.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2016-12-06
- Filing Date
- 2017-11-30
- Publication Date
- 2025-12-05
- Estimated Expiration
- 2037-11-30
AI Technical Summary
Existing liquid transfer devices are inconvenient to operate during the preparation of drug infusion solutions and can easily lead to delays between preparation and administration, affecting the effectiveness of drug infusion solutions.
A one-piece telescopic vial adapter is designed with a safety locking mechanism and clamping device to install and remove individual vials without puncturing the vial stopper. The vials can be safely removed using pliers or electromechanical equipment, avoiding drug waste.
It improves the ease of preparing drug infusion solutions, reduces drug waste, ensures timely administration of drug infusion solutions, and avoids delays caused by advance preparation.
Smart Images

Figure CN114767531B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present invention relates to conventional medical devices, in particular, liquid transfer devices for use with infusion containers and separate injection vials. BACKGROUND
[0002] Commonly owned WIPO International Application No. PCT / IL2014 / 050680 (invention title "Liquid transfer device for use with infusion containers" and published under WIPO International Publication No. WO 2015 / 019343) discloses a liquid transfer device for use with infusion containers and separate injection vials for facilitating the preparation of an infusion container having a medication infusion for administration to a patient. The infusion container can take the form of an infusion bag, an infusion bottle, etc. The infusion container contains an infusion and has an intravenous (IV) or administration port. The liquid transfer device of WO 2015 / 019343 is shown in Figure 4 and Figure 5 shows a liquid transfer device hereinafter referred to as the WO 2015 / 019343 liquid transfer device, WO 2015 / 019343 Figure 6 shows another liquid transfer device, and WO 2015 / 019343 Figure 7 shows yet another liquid transfer device.
[0003] The WO 2015 / 019343 liquid transfer device includes a trifurcated connector body having an IV spear for sealing insertion into an IV port, a vial adapter port having an integral vial adapter for snap fit telescopic mounting on a separate injection vial for fluid communication with the separate injection vial, and a twist-off substitute IV port including a membrane initially sealed prior to being punctured upon insertion of the IV spear of an infusion set. The trifurcated body has three lumens for the IV spear, the vial adapter port, and the twist-off substitute IV port. The three lumens are in 3 directions and are continuous fluid connections such that the preparation of an infusion container having a medication infusion includes the following steps:
[0004] Step 1 : snap fit telescopic mounting of the vial adapter of the liquid transfer device on a separate injection vial.
[0005] Step 2: insertion of the IV spear of the liquid transfer device into the IV port of the infusion container to establish a direct flow between the infusion container and the separate injection vial.
[0006] Step 3: repeatedly transferring the liquid contents in the infusion container back and forth to the separate injection vial to mix or reconstitute the medicament of the injection vial to form the medicament infusion in the infusion container.
[0007] Step 4: opening the alternative IV port of the liquid transfer device and inserting the IV spear of the infusion set in the alternative IV port for establishing a direct flow between the infusion container and the infusion set, ready for gravity flow of the medicament infusion from the infusion container to the patient.
[0008] In some medical institutions, steps 1 to 4 are performed in direct proximity to the patient immediately before administration, although the healthcare provider has to dexterously operate the liquid transfer device and the separate injection vial with a gloved hand. In other medical institutions, such bedside preparation is considered to be inconvenient and cumbersome, and steps 1 to 3 are preferably performed in advance, only step 4 is performed in direct proximity to the patient immediately before administration. However, such early preparation of the medicament infusion itself can lead to a delay between preparation and administration, which can have adverse effects on the medicament infusion.
[0009] It is necessary to make the administration of the medicament infusion more convenient. SUMMARY
[0010] The present invention is directed to a liquid transfer device similar to the above-mentioned WO 2015 / 019343 liquid transfer device. The liquid transfer device of the present invention differs from the former as follows: First, the liquid transfer device comprises an integral telescopic vial adapter for snap-fitting telescopic mounting on the separate injection vial, but leaving it intact, i.e. its injection vial stopper remains unpierced until subsequent pressing. Second, the integral telescopic vial adapter comprises a safety catch mechanism for preventing inadvertent pressing thereof from the pre-pressed state to the pressed state. The safety catch mechanism requires a user release action to release it. The user release action can include, among others, a twisting action, a pulling action, removal of the safety catch, etc. And third, the integral telescopic vial adapter comprises clamping means for irreversibly clamping the vial adapter in its pressed state. The liquid transfer device of the present invention is not limited to a twist-off alternative IV port, but can equally be equipped with, for example, an alternative IV port requiring breaking of a frangible part for opening the alternative IV port for inserting the IV spear of the infusion set into the alternative IV port.
[0011] The liquid transfer device preferably enables easy removal of an unpenetrated, intact, individual syringe from the integral telescoping syringe adapter prior to user pressing the syringe stopper for penetrating it after snap-fit telescoping installation. Such removal can avoid waste of a syringe, which can happen if a drug infusion is prepared early and it is subsequently decided that the drug infusion is no longer needed for administration to a patient. Such removal is preferably achieved by pincers-like compression. The pincers-like compression is achieved by an intact, individual syringe release tool having an opposed pair of inwardly directed protruding portions. The intact, individual syringe release tool can be configured as a pincers-like hand tool or a user-operated electromechanical device. Removal of an unpenetrated, intact, individual syringe using the intact, individual syringe release tool (as opposed to manual removal) can only be enabled by an authorized healthcare provider to remove the unpenetrated, intact, individual syringe. BRIEF DESCRIPTION OF DRAWINGS
[0012] For the purpose of promoting an understanding of the application, the application will now be described, by way of non-limiting example only, with reference to the accompanying drawings in which like reference characters refer to like parts throughout the several views and in which:
[0013] Figure 1 is a diagram of a conventional administration device including an infusion bag, a WO 2015 / 019343 liquid transfer device, an individual syringe, and an infusion set;
[0014] Figure 1A is a longitudinal section of the individual syringe along section line 1A-1A in Figure 1;
[0015] Figure 2A is a top plan view of the WO 2015 / 019343 liquid transfer device;
[0016] Figure 2B is a longitudinal section of the WO 2015 / 019343 liquid transfer device along section line 2B-2B in Figure 2A;
[0017] Figure 3 is a front perspective view of a liquid transfer device including an integral telescoping syringe adapter having a twist-to-release safety catch mechanism for installation on an individual syringe in a pre-compressed state and a pincers-like hand tool for releasing an unpenetrated, intact, individual syringe from the liquid transfer device;
[0018] Figure 4 is a front elevation view of the liquid transfer device of Figure 3 ;
[0019] Figure 5 is a front elevation view of the liquid transfer device of Figure 3Right-side elevation view of the liquid transfer device;
[0020] Figure 6 yes Figure 3 Left elevation view of the liquid transfer device;
[0021] Figure 7 yes Figure 3 Exploded perspective view of the small bottle adapter;
[0022] Figure 8 yes Figure 3 The liquid transfer device along Figure 3 The longitudinal section of section line 8-8 in the middle;
[0023] Figure 9 yes Figure 3 A front view of the liquid transfer device mounted on a separate injection vial in its initial pre-compressed state;
[0024] Figure 10 It is along Figure 9 The cross-section line 10-10 in Figure 3 The liquid transfer device is mounted on a separate injection vial in a longitudinal section;
[0025] Figure 11 It shows a clamp-type hand tool in a pre-clamped state for use from Figure 3 Left-side elevation view of the use of a liquid transfer device to release an unpunctured, untouched, individual vial;
[0026] Figure 12 It is along Figure 11 Mid-section line 12-12 Figure 3 The longitudinal section of the liquid transfer device;
[0027] Figure 13 yes Figure 3 An upright view of the liquid transfer device in the intermediate primed state, mounted on a separate injection vial;
[0028] Figure 14 It is along Figure 13 Section line 14-14 in Figure 3 The liquid transfer device is mounted on a separate injection vial in a longitudinal section;
[0029] Figure 15 yes Figure 3 An orthogonal view of a liquid transfer device mounted on a separate injection vial in a compressed state for fluid communication with that individual injection vial;
[0030] Figure 16 It is along Figure 15 Section line 16-16 inFigure 3 a longitudinal section of the liquid transfer device of
[0031] Figure 17 a front perspective view of the liquid transfer device of
[0032] Figure 18 a longitudinal section of the liquid transfer device of Figure 17 in an intermediate ready state
[0033] Figure 19 a longitudinal section of the liquid transfer device of Figure 17 in a compressed state
[0034] Figure 20 a front perspective view of the liquid transfer device of
[0035] Figure 21 a front perspective view of the liquid transfer device of Figure 20 in a compressed state after removal of its safety catch.
[0036] Detailed description of the preferred embodiments of the invention
[0037] Figure 1 shows an infusion set 10 comprising an infusion container 20, an initial, unpricked, virgin, separate injection vial 30, an infusion set 50 and a WO 2015 / 019343 liquid transfer device 60. The infusion container 20 consists of an intravenous (IV) bag having an IV or administration port 21 and an injection port 22 and containing an infusion fluid 23. The IV port 21 is sealed by a twist-off cap 24 for insertion of an IV lance for administration purposes. The injection port 22 terminates in an injection port spike 26 with a seal plug 27, the purpose being for insertion of a needle of a syringe content into the IV bag 20.
[0038] FIG. 1A shows a single injection vial 30 having a longitudinal injection vial centerline 31 and including a closed end vial tube 32, a tubular vial crown 33 having a crown opening 34, and a vial neck 36 intermediate the vial tube 32 and the vial crown 33. The injection vial 30 includes an injection vial stopper 37 for hermetically sealing the crown opening 34. The vial crown 33 is capped by a band 38. The injection vial 30 contains a drug 39 for introduction into the infusion solution 23 to form a drug infusion solution. The drug 39 can be in solid, powder, or liquid form. The injection vial 30 has an uppermost injection vial surface 41 which is sterilized prior to accessing the injection vial 30 to form the drug infusion solution. The injection vial 30 includes a flip-off tamper evidence cap 42 which is irreversibly removed directly before use to expose the uppermost injection vial surface 41. The tamper evidence cap 42 is intended for single use and therefore cannot be replaced after removal.
[0039] The infusion set 50 includes an IV spike 51 and further includes a first tube 52, forceps 53, a drip chamber 54, a second tube 56, a roller clamp 57, and a male Luer connector 58.
[0040] FIGS. 1, 2A, and 2B show the WO 2015 / 019343 liquid transfer device 60 which includes a trifurcated Y-shaped connector body 61 having a longitudinal connector body centerline 62, an IV spike 63 for sealing insertion into the IV port 21, a vial adapter port 64, and a twist-off surrogate IV port 66. The IV spike 63 has an IV spike tip 63A. The vial adapter port 64 has an integral vial adapter 67 having a vial adapter centerline 68 which is truncated from the longitudinal connector body centerline 62. The vial adapter 67 has a piercing cannula 69 having a piercing cannula tip 71. The connector body 61 has an internal lumen 72 terminating at the IV spike 63, an internal lumen 73 in fluid communication with the piercing cannula 69, and an internal lumen 74 terminating at the surrogate IV port 66. The three internal lumens 72, 73, and 74 are in three directions and are in continuous fluid communication. The surrogate IV port 66 is made of a suitable flexible plastic material (e.g., PVC, etc.) for sealingly receiving the IV spike 51. The surrogate IV port 66 includes a membrane 76 intended to be pierced upon insertion of the IV spike 51. The surrogate IV port 66 includes a proximal portion 66A and a distal portion 66B. In use, the distal portion 66B is twisted off and broken away from the proximal portion 66A, thereby exposing the membrane 76 for piercing by the IV spike 51 of the infusion set. The liquid transfer device 60 can include an IV spike cover 77 to protect the IV spike 63.
[0041] Figures 3 to 16 A liquid transfer device 100A is shown having similar structure and operation as the WO 2015 / 109343 liquid transfer device 60. Figure 3 A pincer hand tool 200 for releasing an unpunctured, unopened, individual injection vial 30 is also shown. The pincer hand tool 200 includes a pincer body 201 having an opposed pair of jaws 202 each terminating at an inwardly directed protrusion 203. The opposed pair of jaws 202 can be easily manually pushed toward one another for applying a pincer compression (force) to thereby release the unpunctured, unopened, individual injection vial 30 as described below, see Figure 11 and Figure 12 .
[0042] The liquid transfer device 100A differs from the liquid transfer device 60 in that it includes an integral telescoping vial adapter 101 having a longitudinal vial adapter centerline 101A and having a two-part structure: an inner vial adapter body 102 and an outer vial adapter body 103. The integral telescoping vial adapter 101 includes a twist release safety catch mechanism 104 for preventing inadvertent user depression from a pre-compression state to a compression state and a clamping device 106 for irreversibly clamping the integral telescoping vial adapter 101 in its clamped state. The integral telescoping vial adapter 101 also includes an inverted T-shaped sealing member 107.
[0043] The inner vial adapter body 102 has an inverted cup shape including an uppermost transverse annular inner vial adapter body wall 108 and a downwardly depending vial crown sleeve 109 having a lowermost vial crown sleeve rim 109A. The inner vial adapter body 102 defines a vial crown cavity 111 for snugly receiving the vial crown 33 therein when the inner vial adapter body 102 is telescopically snap-fit over the vial crown 33. The uppermost transverse annular inner vial adapter body wall 108 has a central uppermost transverse annular inner vial adapter body wall through hole 108A along the longitudinal vial adapter centerline 101A that is located above the uppermost injection vial surface 41 when telescopically snap-fit over the individual injection vial 30.
[0044] The vial crown sleeve 109 includes a primary vial crown sleeve surround 112 having an adjacent first pair of longitudinally directed slits 113A and an adjacent second pair of longitudinally directed slits 113B for respectively forming an opposite pair of vial crown retaining members 114A and 114B. The opposite pair of vial crown retaining members 114 are pivotal relative to the primary vial crown sleeve surround 112 such that each vial crown retaining member 114 has a proximal vial crown retaining member portion 116 and a distal vial crown retaining member portion 117. The uppermost transverse annular inner vial adapter body wall 108 preferably has an opposite pair of cutouts 118 (facing inwardly relative to the opposite pair of vial crown retaining members 114) such that the opposite pair of vial crown retaining members 114 are pivotal on the uppermost transverse annular inner vial adapter wall 108.
[0045] The distal vial crown retaining member portions 117 are each provided with a radially inward vial crown retaining extension 119 toward the lowermost vial crown sleeve edge 109A for snap fitting under the vial crown 33 when the inner vial adapter body 102 is telescopically snap fitted on an initial un-pierced, virgin, individual injection vial 30. Pincer-like compression (force) of the proximal vial crown retaining member portions 116 toward the longitudinal vial adapter centerline 101A causes the vial crown retaining members 114A and 114B to pivot relative to the primary vial crown sleeve surround 112 such that the radially inward vial crown retaining extensions 119 are separated by a distance from the longitudinal vial adapter centerline 101A.
[0046] The uppermost transverse annular inner vial adapter body wall 108 has an opposite pair of upstanding fins 121A and 121B orthogonal to the opposite pair of vial crown retaining members 114A and 114B. The opposite pair of upstanding fins 121 each have a radially outward extension 122 that constitutes an assembly of the twist release safety catch mechanism 104 and the clamping device 106. The vial crown sleeve 109 has a peripheral vial crown sleeve surface 109B having an opposite pair of user indications to indicate a first user step indicated by the annular arrow mark 1 and a second user step indicated by the upstanding arrow mark 2 for activating the liquid transfer device 100A. The vial crown sleeve 109 has an opposite pair of radially outwardly directed finger grips 109C toward the lowermost downwardly depending vial crown sleeve edge 109A.
[0047] The outer vial adapter body 103 has an inverted cup shape that includes an uppermost transverse outer vial adapter body wall 123 and a downward depending skirt 124 having a lowermost skirt rim 124A. The uppermost transverse outer vial adapter body wall 123 is integrally mounted on the vial adapter port 64. The outer vial adapter body 103 defines an inner vial adapter body cavity 126 for snugly telescopingly receiving the inner vial adapter body 102 upon pressing the integral telescoping vial adapter 101 from a pre-pressed state to a pressed state.
[0048] The uppermost transverse outer vial adapter body wall 123 includes a downward depending piercing cannula 127 having a proximal piercing cannula opening 127A and a distal piercing cannula tip 127B. The proximal piercing cannula opening 127A is in fluid communication with the vial adapter port 64 and the distal piercing cannula tip 127B pierces the injection vial stopper 37 in the pressed state of the liquid transfer device 100A.
[0049] The downward depending skirt 124 has a pair of just opposite L-shaped tracks 128 that are co-directional with the longitudinal vial adapter centerline 101A that make up the components of the twist-to-release safety release mechanism 104 and the clamping device 106. The downward depending skirt 124 includes a pair of just opposite slip resistant surfaces 129 that are generally orthogonal to the pair of just opposite L-shaped tracks 128 and the pair of just opposite radially outwardly directed finger grips 109C in the initial pre-pressed state of the liquid transfer device 101A. The downward depending skirt 124 also has a pair of just opposite through-going individual injection vial release apertures 131 for use in the release of the individual injection vial 30. The individual injection vial release apertures 131 are disposed below the slip resistant surfaces 129 and are designed to require a pincer hand tool 200 to apply pincer pressing (force) for release of the un-pierced, original, injection vial 30 and to preclude manual application of pincer pressing.
[0050] Each L-shaped track 128 includes a main track leg 132 co-directional with the longitudinal vial adapter centerline 101 A, a secondary track leg 133 transverse to the longitudinal vial adapter centerline 101 A, and a junction 134 between its main leg 132 and its secondary leg 133. Each L-shaped track 128 has a beginning track end 128A proximate the lowermost skirt 124A and an ending track end 128B proximate the uppermost transverse outer vial adapter body wall 123. Each secondary track leg 133 has a one-way passage arrangement 136 for irreversibly enabling the liquid transfer device 100A. Each ending track end 128B has a one-way passage arrangement 137 that constitutes a component of the clamping device 106.
[0051] The seal member 107 has a seal member tube 138 for mounting on the piercing cannula 127 and a flat seal member base 139 that is placed centrally within the uppermost transverse annular inner vial adapter body wall through hole 108A in the initial pre- compressed state of the liquid transfer device 100A. A central portion of the flat seal member base 139 serves as a seal member membrane 141 for maintaining sterility of the distal piercing cannula tip 127B. The flat seal member base 139 is sealingly placed on the uppermost vial surface 41 upon telescopic mounting of the liquid transfer device 100A on the injection vial 30. The seal member membrane 141 is intended to be pierced by the distal piercing cannula tip 127B in the compressed state of the liquid transfer device 100A.
[0052] Reference is now made to Figures 9 to 16 The use of the liquid transfer device 100A is described.
[0053] Figure 9 and Figure 10 The liquid transfer device 100A is shown mounted on the individual injection vial 30 in the initial pre-compressed state. The vial crown cavity 111 snugly receives the vial crown 33. The radially outward protrusion 122 is disposed at the beginning track end 128A. The seal member base 139 is sealingly placed on the uppermost vial surface 41 after removal of the tamper-evident cap 42. The proximal vial crown retaining member portion 116 is placed at the individual injection vial release hole 131. The unitary telescopic vial adapter 101 has a pre-compression height H1 between the uppermost transverse outer vial adapter body wall 123 and the lowermost vial crown sleeve edge 109A.
[0054] If it is decided not to administer the medication and to re-use the un-pierced, original, individual injection vial 30, the health care provider takes Figure 11 and Figure 12The following steps are shown in FIG. 1 1 : The healthcare provider aligns the retractable vial adapter 101 integral with the forceps hand tool 200 to insert the opposing pair of inwardly pointing protrusions 203 into the just opposite pair of individual injection vial release apertures 131. The healthcare provider exerts a forceps compression (force) on the proximal vial crown retaining member portion 1 16 to push them (as shown by arrow A) toward the longitudinal vial adapter centerline 101 A. The just opposite pair of vial crown retaining members 1 14 pivot away from the longitudinal vial adapter centerline 101 A a distance (as shown by arrow B) from the primary vial crown sleeve 1 12 to release the un-pierced, intact individual injection vial 30. The healthcare provider removes the un-pierced, intact individual injection vial 30 (as shown by arrow C) from the inner vial adapter body 102 for subsequent use and discards the fluid transfer device 100A. The individual injection vial 30 is considered intact in the sense that its injection vial stopper 37 has not been pierced to establish fluid communication with its vial tube 32.
[0055] Figure 13 and Figure 14 The fluid transfer device 100A is shown after the healthcare provider has grasped the just opposite pair of non-slip surfaces 129 with one hand and exerts a rotational force on the just opposite pair of radially outward pointing finger grips 109C to rotate the inner vial adapter body 102 relative to the outer vial adapter body 103 about the longitudinal vial adapter centerline 101 A to the intermediate, ready state. The radially outward projecting portions 122 travel along the secondary track leg 133 until they reach their respective junctures 134. The one-way passage arrangement 136 prevents the fluid transfer device 100A from returning from the intermediate, ready state to its initial, pre-compressed state, thereby preventing the release of the individual injection vial 30. The proximal vial crown retaining member portion 1 16 is rotated away from the individual injection vial release aperture 131, thereby preventing the use of the forceps hand tool 200 to release the intact individual injection vial 30 from the fluid transfer device 100A.
[0056] Figure 15 and Figure 16The liquid transfer device 100A is shown in its final, compressed state after the outer vial adapter body 103 is telescopically mounted onto the inner vial adapter body 102 such that the outer vial adapter body 103 snugly receives the inner vial adapter body 102 therein. The radially outwardly projecting portions 122 travel along the main track leg 132 until they pass through the one-way passage arrangement 137 at the end track end 128B, thereby irreversibly clamping the integral telescoping vial adapter 101 in its compressed state. The distal piercing cannula tip 127B pierces the seal member membrane 141 and subsequently pierces the injection vial stopper 37 for establishing fluid communication between the piercing cannula 127 and the vial tube 32 for preparing the drug infusion. The integral telescoping vial adapter 101 has a compressed height H2 between the uppermost transverse outer vial adapter body wall 123 and the lowermost vial crown sleeve edge 109A, where H1 > H2.
[0057] Figures 17 to 19 The liquid transfer device 100B is shown having similar structure as the liquid transfer device 100A, therefore like components are numbered the same. The latter 100B differs from the former 100A in that the latter 100B includes a pull release safety catch mechanism 151 instead of the twist release safety catch mechanism 104. Figure 17 The liquid transfer device 100B is shown in its pre-compressed state having a pre-compressed height H1. Figure 18 The liquid transfer device 100B is shown in its intermediate, ready state after the inner vial adapter body 102 is initially extended from the outer vial adapter body 103 in the same direction as the longitudinal vial adapter centerline 101A, having a ready vial adapter height H3 between the uppermost transverse outer vial adapter body wall 123 and the lowermost vial crown sleeve edge 109A, where H3 > H1. Figure 19 The liquid transfer device 100B is shown in its compressed state after the outer vial adapter body 103 snugly telescopically receives the inner vial adapter body 102 therein, having a compressed height H2, where H1 > H2.
[0058] Figure 20 and Figure 21A liquid transfer device 100C is shown having a similar structure as the liquid transfer device 100A, therefore like components are numbered the same. The latter 100C differs from the former 100A in that the latter 100C includes a safety catch mechanism 161 different from the twist-to-release safety catch mechanism 104, the safety catch mechanism 161 having a safety catch 162. The latter 100C includes an alternative IV port having a frangible component 163 that breaks to enable the IV lance 51 to be inserted into the alternative IV port. The latter 100C includes a pair of clamping components 164 just the opposite, the clamping components 164 forming a component of a clamping device for irreversibly clamping the integral telescoping vial adapter 101 in its final, compressed state.
[0059] Figure 20 The safety catch 162 is shown extending laterally through the outer vial adapter body 103 preventing manual compression of the liquid transfer device 100C from its pre-compressed state to its compressed state. The integral telescoping vial adapter 101 has a pre-compressed height H1. Figure 21 The liquid transfer device 100C is shown in its compressed state after the safety catch 162 has been removed from the outer vial adapter body 103 enabling the outer vial adapter body 103 to snugly, telescopingly receive the inner vial adapter body 102 therein. The integral telescoping vial adapter 101 has a compressed height H2, where H1 > H2.
[0060] While particular embodiments of the present application have been 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 application.
Claims
1. A fluid transfer device for use with an infusion container, a separate vial, and an infusion set, the infusion container containing an infusion solution and having an intravenous injection port for administering the infusion solution, the separate vial having a vial tube closed at one end containing the medication, a tubular vial crown with a crown opening plugged by a non-punctured vial stopper, and an uppermost vial surface, the infusion set including an infusion set IV spear for sealing insertion into an alternative IV port and a connector for administration to a patient. The fluid transfer device includes a three-pronged connector body with a fluid transfer device IV spearhead, a vial adapter port, and a replacement IV port. The fluid transfer device IV spearhead is used to seal and insert into the IV port of the infusion container. The vial adapter port has an integrated telescopic vial adapter for telescopically snapping onto the individual injection vial. The replacement IV port is used to seal and receive the IV spearhead of the infusion set. The IV lance of the fluid transfer device is in direct and continuous fluid communication with the vial adapter port and the alternative IV port, thereby enabling the initial formation of the drug infusion solution in the infusion container and its subsequent administration to the patient. The integrated telescopic vial adapter has a longitudinal vial adapter centerline and includes: i) Inner vial adapter body, the inner vial adapter body having an inverted cup shape, having an uppermost horizontal annular inner vial adapter body wall and a lowermost downward-hanging vial crown sleeve. The inner vial adapter body defines a vial crown cavity, which is used to receive the tubular vial crown tightly when the inner vial adapter body is telescopically mounted on the tubular vial crown. ii) The outer vial adapter body has an inverted cup shape, having an uppermost horizontal outer vial adapter body wall and a downwardly hanging skirt. The outer vial adapter body defines an inner vial adapter body cavity, which is used to receive the inner vial adapter body in a close and telescopic manner when the integral telescopic vial adapter is pressed from an initial pre-compression state with a pre-compression height H1 to a final compression state with a compression height H2, wherein H1>H2, and wherein the pre-compression height H1 and the compression height H2 are located between the uppermost transverse outer vial adapter body wall and the lowermost vial crown sleeve edge. A downward-pointing puncture cannula, the downward-pointing puncture cannula having a proximal puncture cannula opening in fluid communication with the vial adapter port and a distal puncture cannula tip for puncturing the vial stopper to achieve fluid communication with the vial tubing. iii) A safety locking mechanism for preventing an inattentive user from pressing the vial adapter from the pre-compressed state to the compressed state, and iv) A clamping device for irreversibly clamping the vial adapter in the final compressed state. The vial adapter is configured such that, in the pre-compressed state, the distal puncture cannula tip is positioned above the unpunctured vial stopper, and in the compressed state, the distal puncture cannula tip punctures through the vial stopper for fluid communication with the vial tubing.
2. The device according to claim 1, wherein the safety locking mechanism comprises a twist-release safety locking mechanism, including: A pair of exactly opposite L-shaped tracks inside the main body of the outer vial adapter. Each of the L-shaped tracks has a main track leg aligned with the longitudinal centerline of the bottle adapter, a secondary track leg transverse to the longitudinal centerline of the bottle adapter, a starting track end adjacent to the lowermost downward-hanging skirt, and an ending track end adjacent to the uppermost transverse outer wall of the bottle adapter body. Each of the said secondary track legs includes a unidirectional channel arrangement for irreversibly moving the integrated telescopic vial adapter in its intermediate moving state. The inner vial adapter body has a pair of radially outwardly protruding portions that are exactly opposite to each other, for traveling along the pair of L-shaped tracks from the start track end in the pre-compressed state to the end track end in the compressed state. The twist-release safety latch mechanism requires the inner vial adapter body to be initially manually rotated relative to the outer vial adapter body around the longitudinal centerline of the vial adapter. This rotation is used to move the vial adapter from the initial pre-compression state to the intermediate moving state, thereby enabling the vial adapter to be pressed from the pre-compression state to the compression state.
3. The apparatus of claim 2, wherein each of the end track ends includes a unidirectional channel arrangement for irreversibly clamping the vial adapter in the final compressed state.
4. The device according to claim 2, wherein the inner vial adapter body has a pair of radially outwardly pointing finger-like grippers facing the lowermost downwardly hanging vial crown, and the outer vial adapter body has a pair of opposite anti-slip surfaces, the opposite pair of anti-slip surfaces being orthogonal to the opposite pair of radially outwardly pointing finger-like grippers in the initial pre-compression state, for assisting the manual rotation of the inner vial adapter body relative to the outer vial adapter body.
5. The device according to claim 1, wherein the safety locking mechanism comprises a pull-release safety locking mechanism, the pull-release safety locking mechanism being required to release the safety locking mechanism in an initial manual extension to an intermediate movement state relative to the outer bottle adapter body in the same direction as the center line of the longitudinal bottle adapter, thereby realizing the pressing of the bottle adapter from the pre-pressed state to the pressed state.
6. The device according to claim 1, wherein the safety latch mechanism includes a safety latch extending laterally through the outer vial adapter body in the pre-compressed state, thereby preventing the integrated telescopic vial adapter from being pressed from the pre-compressed state to the compressed state, and thereby enabling the integrated telescopic vial adapter from being pressed from the pre-compressed state to the compressed state by manually removing the safety latch from the outer vial adapter body.
7. The apparatus of claim 1, wherein the apparatus is used in conjunction with an untouched individual vial release tool having a pair of opposing inwardly pointing protrusions, for applying a clamping clamp to release an unpunctured, untouched individual vial from the integral telescopic vial adapter. The vial crown sleeve includes a main vial crown sleeve surround and a pair of opposite vial retaining members pivoting relative to the main vial crown sleeve surround, such that each vial crown retaining member has a proximal vial crown retaining member portion and a distal vial crown retaining member portion. Each of the distal vial crown retaining components has a radially inwardly extending vial crown retaining extension toward the lowermost vial crown flange, the radially inwardly extending vial crown retaining extension being designed to engage under the vial crown when the inner vial adapter body is telescopically snapped onto the initial, unpunctured, untouched individual vial. The opposite pair of proximal vial crown retaining portions pivot relative to the main vial crown sleeve surrounding the vial, such that the clamping force applied to the opposite pair of proximal vial crown retaining portions separates the opposite pair of radially inward vial crown retaining extensions from the longitudinal vial adapter centerline by a certain distance, for releasing the unpunctured, untouched individual vial from the inner vial adapter body.
8. The apparatus of claim 7, wherein the downwardly draped skirt comprises a pair of opposite through-holes for providing an inlet for an untouched individual vial release tool having a pair of opposing inwardly pointing protrusions for applying clamping pressure in the pre-clamped state of the vial adapter.
9. The apparatus of claim 7, wherein when the clamping action is applied, the opposite pair of vial crown retaining members pivot on the uppermost transverse annular inner vial adapter body wall.
10. An untouched, single vial release tool having a pair of opposing inwardly pointing protrusions for use with the liquid transfer device according to claim 7 and configured as a plier-like manual tool having a pair of opposing clamps having a pair of opposing inwardly pointing protrusions.
Citation Information
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