Infusion device with telescoping bottle adapter for use with an infusion container and another infusion bottle

Abstract

To provide an infusion device that can further simplify the administration of infused medicinal liquids. [Solution] The infusion device includes a bottle adapter, an IV spike, an alternative IV port holder, and a flow control member. The bottle adapter includes a puncture cannula for piercing the stopper of an infusion bottle. The alternative IV port holder is a portion for receiving the alternative IV port. The flow control member is configured to move to both a mixing position, which allows flow between the puncture cannula and the IV spike, and an administration position, which allows flow between the IV spike and the alternative IV port holder and seals the puncture cannula. The alternative IV port holder extends in the same direction as the longitudinal centerline of the IV spike.

Description

[Technical Field]

[0001] The present invention relates generally to medical devices, and more particularly to an infusion device for use with an infusion bottle separate from an infusion fluid container. [Background technology]

[0002] Patent Document 1 discloses an infusion device used with an infusion liquid container and another infusion bottle. This infusion device facilitates the preparation of an infusion liquid to be administered to a patient in the infusion liquid container. The infusion liquid container may be in the form of a bag, a bottle, or the like. The infusion liquid container contains the infusion liquid and is equipped with a drip port or an administration port. The infusion device shown in Figures 4 and 5 of Patent Document 1 will hereinafter be referred to as the infusion device of Patent Document 1. Another infusion device is shown in Figure 6 of Patent Document 1, and yet another infusion device is shown in Figure 7 of Patent Document 1.

[0003] The infusion device of Patent Document 1 includes a three-pronged connector with an IV spike, a bottle adapter port, and a threaded alternative IV port. The IV spike is inserted into the IV port and sealed. The bottle adapter port is integrated with the bottle adapter. The bottle adapter is attached to the infusion bottle with a telescopic snap fit so as to communicate with the bottle. The threaded alternative IV port includes a septum. This septum is initially sealed and is pierced by the insertion of the IV spike of the infusion set. The IV spike includes only one lumen, the bottle adapter port includes only one lumen, and the threaded alternative IV port includes only one lumen. These three lumens allow flow in three directions continuously so that the infusion fluid can be prepared in the infusion fluid container in the next step.

[0004] Step 1: Snap the infusion device bottle adapter onto another infusion bottle, like a telescope. Step 2: Insert the drip spike of the infusion device into the drip port of the infusion container to open a direct flow path between the infusion container and the separate infusion bottle. Step 3: The liquid contents of the infusion bottle are repeatedly transferred back and forth between the infusion bottle and another infusion bottle to mix or reconstitute the medication in the infusion bottle and form a liquid infusion in the infusion bottle. Step 4: Open the alternate drip port on the infusion device and insert the drip spike of the infusion set into it to establish a direct fluid path between the infusion container and the infusion set. The infusion set is prepared to allow gravity flow of the infusate from the infusion container to the patient. It would be even more convenient to further simplify the administration of infusion fluids. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2015 / 019343 [Patent Document 2] International Publication No. 2018 / 178971 [Patent Document 3] International Publication No. 2018 / 104930 Summary of the Invention

[0006] The present invention is directed to an infusion device similar to the infusion device of Patent Document 1. The infusion device of the present invention differs from the former in the following ways: The infusion device includes a rotating stopper mechanism (i.e., a flow control member). The stopper mechanism controls flow between an IV spike, a bottle adapter, and a threaded alternative IV port attached to the bottle adapter. The infusion device is integrated with a telescopic bottle adapter. The bottle adapter is snap-fit ​​and telescopically attaches to an infusion bottle, and only when subsequently compressed does it pierce the stopper of the infusion bottle. The infusion device may include a latch mechanism. The latch mechanism prevents the stopper mechanism from rotating between three positions when the bottle adapter is in a pre-compressed state. The bottle adapter includes a safety catch mechanism. The safety catch mechanism prevents accidental compression from the pre-compressed state to the compressed state. The safety catch mechanism requires user action to release it. The user's release action preferably includes removal of the safety catch. Patent Document 2 discloses another safety catch mechanism. The bottle adapter also includes a clamping mechanism that irreversibly tightens itself when in a compressed state. The infusion device of the present invention is not limited to including threaded alternative infusion ports, but may also include alternative infusion ports such as, for example, a fragile part that must be broken to open and insert the infusion set's infusion spike therein.

[0007] When the stopcock mechanism rotates between two positions, the positions include: a mixing position (or reconstitution position) for preparing the infusion by allowing flow between the drip spike and the bottle adapter port; an administration position for administering the infusion by allowing flow between the drip spike and the alternate drip port; and an additional position for sealing the drip spike (i.e., blocking flow between the drip spike, the bottle adapter port, and the alternate drip port). This position can be used as an initial position before the mixing position.

[0008] When the stopper mechanism rotates between three positions, the positions include: the first set position, which is a position for sealing the drip spike; the intermediate ready position, which is a position for preparing the infusion fluid by enabling flow between the drip spike and the bottle adapter port; and the final administration position, which is a position for administering the infusion fluid by enabling flow between the drip spike and the alternate drip port. The stopper mechanism includes an L-shaped flow control member. This flow control member includes a shaft and a lever and rotates about an axis of rotation. The flow control member conforms to standard specifications, with the lever indicating the sealed port. The stopper mechanism is rotatable in one direction from the first set position, through the intermediate ready position, to the final administration position. However, a healthcare provider may accidentally omit the priming step and rotate the stopper mechanism from the set position to the administration position without stopping at the ready position. Therefore, the stopper mechanism is rotatable from the final administration position to the first set position.

[0009] In an infusion device, preferably as disclosed in U.S. Patent No. 5,999,499, an integrated vial adapter, such as a telescopic one, is attached by a snap fit, allowing the user to quickly remove the intact infusion vial from the vial adapter before compressing it to puncture the vial stopper. This removal prevents the infusion vial from being wasted if the infusion solution is prepared too early and no longer needs to be administered to the patient. This removal is preferably achieved by pinching and compressing the vial with a pliers-like device. The pinching and compressing can be performed by a device for releasing the intact infusion vial. The device has a pair of inwardly facing protrusions and can be configured as a hand tool such as pliers or a user-operated power tool. Using this device to remove the intact infusion vial ensures that only an authorized healthcare provider can remove the vial, unlike manual removal. The invention is defined in the appended claims. [Brief explanation of the drawings]

[0010] In order to understand the invention and to see how it may be carried out in practice, preferred embodiments will now be described with reference to the accompanying drawings, in which like parts are numbered and in which:

[0011] [Figure 1] FIG. 1 is a perspective view of a conventional administration set including an infusion bag, the infusion device of Patent Document 1, an infusion bottle, and an infusion set. [Figure 1A] 1A is a longitudinal cross-sectional view of the infusion bottle taken along line 1A-1A in FIG. [Figure 2A] FIG. 1 is a top view of the infusion device of Patent Document 1. [Figure 2B] FIG. 2B is a longitudinal cross-sectional view of the infusion device of Patent Document 1 taken along line 2B-2B in FIG. 2A. [Figure 3] 1 is a front perspective view of an infusion device according to a first embodiment of the invention, the infusion device including a telescoping vial adapter in a pre-compressed state and a hand tool, such as pliers, for removing an unpunctured, intact infusion vial from the vial adapter. [Figure 4] FIG. 4 is an exploded view of the infusion device of FIG. 3. [Figure 5A] FIG. 4 is a top perspective view of the drip spike body of the infusion device of FIG. 3. [Figure 5B] FIG. 1 is a top view of the drip spike body. [Figure 5C] 5C is a longitudinal cross-sectional view of the drip spike body taken along line 5C-5C of FIG. 5B. [Figure 5D] FIG. 1 is a bottom perspective view of the drip spike body. [Figure 5E] 5B is an enlarged view of a portion of the drip spike body enclosed by a circle A in FIG. 5A. [Figure 6A] 4 is a top view of the flow control member of the infusion device of FIG. 3. [Figure 6B] FIG. 10 is a bottom view of the flow control member. [Figure 6C] FIG. 10 is a bottom perspective view of the flow control member. [Figure 6D] FIG. 6D is an enlarged view of a portion of the flow control member circled in FIG. 6C. [Figure 6E] FIG. 2 is a side view of a flow control member. [Figure 6F] FIG. 6F is a cross-sectional view of the flow control member of FIG. 6E. [Figure 7A] 4 is a top perspective view of the inner body of the bottle adapter of the infusion device of FIG. 3. [Figure 7B] 1A and 1B are a front view and a longitudinal cross-sectional view of the inner body of the bottle adapter. [Figure 7C] 1A and 1B are side and longitudinal cross-sectional views of the inner body of the bottle adapter. [Figure 8A] 4 is a top perspective view of the outer body of the bottle adapter of the infusion device of FIG. 3. [Figure 8B] 1A and 1B are front and longitudinal cross-sectional views of the outer body of the bottle adapter; [Figure 8C] 1A and 1B are side and longitudinal cross-sectional views of the outer body of the bottle adapter; [Figure 9A] FIG. 4 is a front view of the infusion device of FIG. 3 in an initial pre-compressed state. [Figure 9B] 9B is a longitudinal cross-sectional view of the infusion device of FIG. 9A. [Figure 9C] FIG. 9C is an enlarged view of a portion of the infusion device enclosed by a circle C in FIG. 9B. [Figure 9D] FIG. 9C is a longitudinal cross-sectional view of the infusion device of FIG. 9B. [Figure 9E] FIG. 9E is an enlarged view of a portion of the infusion device enclosed by the circle D in FIG. 9D. [Figure 10A] 4 is a front view of the infusion device of FIG. 3 showing the removal of an intact, punctured infusion vial from the telescoping vial adapter using a hand tool such as pliers. [Figure 10B] 10B is a longitudinal cross-sectional view of the infusion device of FIG. 10A. [Figure 11A] 4 is a front view of the infusion device of FIG. 3 after the telescoping bottle adapter has been compressed. [Figure 11B] FIG. 11B is a longitudinal cross-sectional view of the infusion device of FIG. 11A. [Figure 11C] FIG. 11C is an enlarged view of a portion of the infusion device enclosed by a circle E in FIG. 11B. [Figure 12A] 4 is a front view of the infusion device of FIG. 3 in a state where it is ready to inject a medical solution. [Figure 12B] 1 is a side view of the infusion device ready to inject a medical solution; FIG. [Figure 12C] FIG. 12C is a longitudinal cross-sectional view of the infusion device of FIG. 12B. [Figure 12D] FIG. 12D is an enlarged view of a portion of the infusion device enclosed by circle F in FIG. 12C. [Figure 13A] 4 is a front view of the infusion device of FIG. 3 ready to administer an infusion fluid; FIG. [Figure 13B] 1 is a side view of an infusion device ready to administer an infusion fluid; FIG. [Figure 13C] FIG. 13C is a longitudinal cross-sectional view of the infusion device of FIG. 13B. [Figure 13D] FIG. 13D is an enlarged view of a portion of the infusion device enclosed by a circle G in FIG. 13C. [Figure 14] 1 is a front perspective view of an infusion device according to a second embodiment of the invention, the infusion device including a telescoping vial adapter in a pre-compressed state attached to an unpunctured, intact infusion vial, and a hand tool, such as pliers, for removing the infusion vial from the vial adapter. [Figure 15] FIG. 15 is an exploded view of the infusion device of FIG. [Figure 16A] FIG. 15 is a top perspective view of the drip spike body of the infusion device of FIG. 14. [Figure 16B] FIG. 16B is a front view of the drip spike body of FIG. 16A. [Figure 16C] FIG. 16B is a bottom perspective view of the drip spike body of FIG. 16A. [Figure 17] 15A-15C are views of the flow control member of the infusion device of FIG. 14 from several different angles. [Figure 18A] 15A-15C are views of the inner body of the bottle adapter of the infusion device of FIG. 14 from several different angles. [Figure 18B] 18B is a top view and a longitudinal cross-sectional view of the inner body of the bottle adapter of FIG. 18A. [Figure 19A] 15A-15C are views of the outer body of the bottle adapter of the infusion device of FIG. 14 from several different angles. [Figure 19B]19B is an enlarged perspective view including the front and top of the outer body of the bottle adapter of FIG. 19A. FIG. [Figure 19C] 19B is a longitudinal cross-sectional view of the outer body of the bottle adapter of FIG. 19A. [Figure 20A] FIG. 1 is a front perspective view of a setup arrangement including an infusion device, an IV bag, and a telescoping bottle adapter in an initial pre-compressed state attached to an infusion bottle. [Figure 20B] FIG. 1 is a front view of an infusion device equipped with a plug position icon display mechanism showing a blocked icon. [Figure 21A] FIG. 10 is a right side view of the infusion device showing the removal of an intact, punctured infusion vial from the telescoping vial adapter using a hand tool such as pliers. [Figure 21B] 21B is a longitudinal cross-sectional view of the infusion device of FIG. 21A. [Figure 22A] FIG. 10 is a front perspective view of the infusion device after the telescoping bottle adapter has been compressed. [Figure 22B] 22B is a longitudinal cross-sectional view of the infusion device of FIG. 22A. [Figure 23A] 1 is a front perspective view of the infusion device in a state where it is ready to inject a medical solution. FIG. [Figure 23B] 23B is a longitudinal cross-sectional view of the infusion device of FIG. 23A. [Figure 24A] 1 is a front perspective view of the infusion device in a state for administering an infusion fluid; FIG. [Figure 24B] 24B is a longitudinal cross-sectional view of the infusion device of FIG. 24A. [Figure 25] FIG. 10 is a front perspective view of an infusion device according to a third embodiment of the invention. [Figure 26] FIG. 26 is an exploded view of the infusion device of FIG. 25. [Figure 27A] FIG. 26 is a top perspective view of the drip spike body of the infusion device of FIG. 25. [Figure 27B] FIG. 1 is a top view of the drip spike body. [Figure 27C] FIG. 27C is a longitudinal cross-sectional view of the drip spike body taken along line 27C-27C of FIG. 27B. [Figure 27D] FIG. 1 is a bottom perspective view of the drip spike body. [Figure 27E]27B is an enlarged view of a portion of the drip spike body enclosed by a circle A in FIG. 27A. [Figure 28A] 26 is a top view of the flow control member of the infusion device of FIG. 25. [Figure 28B] FIG. 10 is a bottom view of the flow control member. [Figure 28C] FIG. 10 is a bottom perspective view of the flow control member. [Figure 28D] FIG. 28D is an enlarged view of a portion of the flow control member circled in FIG. 28C. [Figure 28E] FIG. 2 is a side view of a flow control member. [Figure 28F] 28F is a cross-sectional view of the flow control member taken along line 28F-28F of FIG. 28E. [Figure 29A] FIG. 26 is a top perspective view of the bottle adapter body of the infusion device of FIG. 25. [Figure 29B] 1A and 1B are a front view and a longitudinal cross-sectional view of a bottle adapter body. [Figure 29C] 1A and 1B are a side view and a longitudinal cross-sectional view of a bottle adapter body. [Figure 30A] FIG. 26 is a front view of the infusion device of FIG. 25. [Figure 30B] 30B is a longitudinal cross-sectional view of the infusion device of FIG. 30A. [Figure 30C] FIG. 30C is an enlarged view of the portion of the infusion device circled in FIG. 30B. [Figure 31A] FIG. 26 is a front view of the infusion device of FIG. 25 in a state where it is ready to be infused. [Figure 31B] 1 is a side view of the infusion device in a state where it is ready to inject a medical solution. FIG. [Figure 31C] FIG. 31C is a longitudinal cross-sectional view of the infusion device of FIG. 31B. [Figure 31D] FIG. 31D is an enlarged view of the portion of the infusion device circled in FIG. 31C. [Figure 32A] FIG. 26 is a front view of the infusion device of FIG. 25 in a state ready to administer infusion fluid. [Figure 32B] 1 is a side view of the infusion device in a state to administer an infusion fluid. FIG. [Figure 32C] FIG. 32C is a longitudinal cross-sectional view of the infusion device of FIG. 32B. [Figure 32D] FIG. 32D is an enlarged view of a portion of the infusion device enclosed by circle D in FIG. 32C. DETAILED DESCRIPTION OF THE INVENTION

[0012] Certain terminology is used in the following description for convenience only and is not intended to be limiting. For example, the words "lower," "bottom," "upper," and "top" designate directions in the drawings to which reference is made. The words "inwardly," "outwardly," "upwardly," and "below" refer to directions toward and away from the geometric center of the device described in accordance with the present invention and its designated components, respectively. Unless otherwise indicated, the singular terms "a," "an," and "the" should be read to mean "at least one" rather than being limited to one element. Terms include the above-mentioned words, derivatives thereof, and similar terms.

[0013] It should also be understood that the terms "about," "approximately," "around," "substantially," and the like, used below when referring to dimensions or characteristics of components of the invention, do not exclude slight variations from those values ​​where the described dimensions / characteristics are not precise boundaries or parameters but are functionally similar. At the very least, references involving numerical parameters will include variations to the extent that they do not alter the lowest digits using mathematical and engineering principles accepted in the industry (e.g., rounding approximations, systematic errors such as measurement errors, manufacturing tolerances).

[0014] FIG. 1 shows an administration set 10. The set 10 includes an infusion solution container 20, a separate infusion bottle 30 that is initially intact and punctured, an infusion set 50, and an infusion device 60 of the '661 patent. The infusion solution container 20 comprises an infusion bag with an infusion port or administration port 21 and an injection port 22. The infusion bag contains an infusion solution 23. The infusion port 21 is sealed by a threaded cap 24. An infusion spike is inserted into the infusion port 21 for administration purposes. The injection port 22 is closed at its tip 26 by a sealing plug 27. A syringe needle is inserted into the sealing plug 27, and the contents of a syringe are inserted into the infusion bag 20.

[0015] FIG. 1A shows an infusion bottle 30. The infusion bottle 30 has a longitudinal centerline 31. The infusion bottle 30 includes a closed-ended, cylindrical body 32, a tubular crown 33 including an opening 34, and a neck 36 intermediate the body 32 and the crown 33. The infusion bottle 30 includes a stopper 37 for sealing the crown opening 34. The crown 33 is covered by a band 38. The infusion bottle 30 contains a drug 39 that, when introduced into the infusion solution 23, forms the infusion solution. The drug 39 may be solid, granular, or liquid. The infusion bottle 30 has a top surface 41. The top surface 41 keeps the infusion bottle 30 sterile until it is used to form the infusion solution. The infusion bottle 30 includes a tamper-evident cap 42. The cap 42 is removed immediately before use to expose the top surface 41. The cap 42 is disposable and cannot be replaced once removed. Even if the cap 42 is irreplaceably removed, the infusion bottle 30 is still considered intact. The infusion bottle 30 is intact until the stopper 37 is completely punctured, opening a fluid path to the interior.

[0016] Infusion set 50 includes drip spike 51 , and further includes first tubing 52 , clamp 53 , drip chamber 54 , second tubing 56 , roller clamp 57 , and male luer connector 58 .

[0017] As shown in Figures 1, 2A, and 2B, the infusion device 60 of Patent Document 1 includes a three-pronged Y-shaped connector 61 (having a longitudinal centerline 62), an IV spike 63 that is inserted into and sealed to the IV port 21, a bottle adapter port 64, and a threaded alternate IV port 66. The IV spike 63 has a tip 63A. A bottle adapter 67 is integrated into the bottle adapter port 64. The centerline 68 of the bottle adapter 67 intersects the longitudinal centerline 62 of the connector. The bottle adapter 67 includes a puncture cannula 69 with a tip 71. The connector 61 includes a lumen 72 that terminates at the IV spike 63, a lumen 73 that communicates with the puncture cannula 69, and a lumen 74 that terminates at the alternate IV port 66. The three lumens 72, 73, and 74 direct flow continuously in three directions. The alternate infusion port 66 is formed from a flexible resinous material, such as PVC, suitable for receiving and sealing the infusion spike 51. The alternate infusion port 66 includes a septum 76. The septum 76 is pierced to receive the infusion spike 51. The alternate infusion port 66 has a proximal end 66A and a distal end 66B. In use, the distal end 66B is threaded off the proximal end 66A, exposing the septum 76 so that it can be pierced by the infusion spike 51 of an infusion set. The infusion device 60 may also include a cover 77 to protect the infusion spike 63.

[0018] FIGS. 3-8C show an infusion device 100 according to a first embodiment of the invention. The infusion device 100 differs in configuration and operation from the infusion device 60 of Patent Document 1. FIG. 3 also shows a pliers-like hand tool 200 for removing an unpierced, intact infusion bottle 30. The hand tool 200 includes a body 201 and a pair of opposing claws 202. Each of the claws 202 has an inward protrusion 203. The claws 202 can be easily moved toward each other by hand, pinching and compressing the unpierced, intact infusion bottle 30 like a pair of pliers to remove it. This will be described later with reference to FIGS. 10A and 10B.

[0019] The infusion device 100 includes a three-pronged, Y-shaped drip spike body 101. The drip spike body 101 has a longitudinal centerline 101A with an drip spike 102 on one side, a flow control member port 103 in the middle, and an alternate drip port holder 104 on the other side. The alternate drip port holder 104 receives and seals an alternate drip port 106. The flow control member port 103 has an axis 103A that intersects the longitudinal centerline 101A of the drip spike body. The alternate drip port 106 may be incorporated as a threaded or broken-off part, etc. The drip spike 102 and the alternate drip port holder 104 are oriented in the same direction and are aligned with the longitudinal centerline 101A of the drip spike body. The drip spike body 101 includes a bottle adapter support 107. The vial adapter support 107 extends from the central flow control member port 103 and is inclined at approximately 135° relative to the IV spike 102 and approximately 45° relative to the alternate IV port 104 in the top perspective view shown in FIG. 3 . The infusion device 100 includes a telescoping vial adapter 108 attached to the vial adapter support 107. The vial adapter 108 may be permanently or removably attached to the support 107. The vial adapter 108 has a longitudinal centerline 108A that intersects with the longitudinal centerline 101A of the IV spike body. The vial adapter 108 includes an inner body 109 and an outer body 111 and is adapted to be compressed from an initial, pre-compressed state to a final, compressed state. In the compressed state, the outer body 111 slides the inner body 109 therein. The vial adapter 108 includes a puncture cannula 112 (see FIGS. 8A-8C ). In the compressed state of the vial adapter, the puncture cannula 112 selectively pierces the stopper 37 of the infusion vial. The puncture cannula 112 is protected by a thin sheath 113 and remains sterile until the infusion device 100 is used to administer the infusion fluid.

[0020] The infusion device 100 includes a stopcock mechanism 114 that can be manually rotated between three positions. The stopcock mechanism 114 includes an L-shaped flow control member 116. The flow control member 116 rotates clockwise relative to the drip spike body 101, as indicated by arrow A in the top perspective view of FIG. 3 . The flow control member 116 has an axis of rotation 116A that is perpendicular to and intersects the longitudinal centerline 101A of the drip spike body. The flow control member 116 includes a shaft 117 and a lever 118. The shaft 117 is securely inserted into and sealed to the flow control member port 103. The lever 118 is rotated by being held between the healthcare provider's thumb and index finger. The stopcock mechanism 114 controls flow through the infusion device 100 when the bottle adapter 108 is in a compressed state. The stopcock 114 mechanism rotates the flow control member 116 clockwise from an initial set position to a final dispense position, as shown in the top perspective view of Figure 3. This allows the infusion fluid prepared in the intermediate priming position to be administered to the patient. The stopcock mechanism 114 seals the drip spike 102 in the set position, the alternate drip port 106 in the primed position, and the bottle adapter 108 in the dispense position.

[0021] The infusion device 100 includes the following components: A safety catch mechanism 119 prevents a user from accidentally compressing the vial adapter 108 from the pre-compressed state to the compressed state. The safety catch mechanism 119 incorporates a tuning-fork-like safety catch 121, which extends across the vial adapter's outer body 111 when the vial adapter 108 is in the pre-compressed state. A clamping mechanism 122 irreversibly clamps the vial adapter 108 in the compressed state. A latching mechanism 123 prevents operation of the bung mechanism 114 when the vial adapter 108 is in the pre-compressed state. A bung rotation limiting mechanism 124 prevents a healthcare provider from further rotating the flow control member 116 beyond the final dispensing position. A detent mechanism 126 generates an audible alarm when the flow control member 116 is rotated from the set position to the ready position and from the ready position to the dispensing position. The audible warning is preferably a click as the detents engage with the grooves and is heard twice by the healthcare provider during operation of the infusion device 100. Thus, the detent mechanism 126 may include a single groove and a pair of detents, or may include a single detent and a pair of grooves.

[0022] 5A-5E show that the drip spike 102 includes a lumen 127 that communicates with the flow control member port 103. The alternate drip port holder 104 includes a lumen 128 that is collinear with the drip spike lumen 127 and communicates with the flow control member port 103. The vial adapter support 107 includes a lumen 129 that communicates with the flow control member port 103. The lumen 129 is stepped, dividing it into a narrow main section 129A that is closer to the flow control member port 103 and a wider secondary section 129B that is further from the flow control member port 103.

[0023] Flow control member port 103 includes a first edge 131 on one side and a second edge 132 on the opposite side. First edge 131 is stepped and forms part of bung rotation limiting mechanism 124. First edge 131 includes a protruding arc portion 133. Arc portion 133 has an arc length of approximately 135°, limiting rotation of flow control member 116 about rotation axis 116A to approximately 225° from the set position to the dispense position. Arc portion 133 includes a wall 133A and an opposing wall 133B.

[0024] Bottle adapter support 107 terminates in flange 134 that attaches to bottle adapter 108. Bottle adapter support 107 has a latch hole 136 extending therethrough. Latch hole 136 is one element of latch mechanism 123 and extends from flow control member port 103 to flange 134. Detent mechanism 126 includes a groove 137 on bottle adapter support 107. Groove 137 is adjacent first edge 131 of the flow control member port and forward of arcuate wall 133B thereof.

[0025] 6A-6F, the flow control member lever 118 includes a substantially rectangular main portion 138 and an elongated secondary portion 139 that is held between the healthcare provider's thumb and index finger. The top surface 141 of the lever 118 faces away from the flow control member port 103 and includes symbols indicating the flow paths of the infusion device 100 during operation. The flow paths include a priming flow path between the drip spike 102 and the bottle adapter 108 and an administration flow path between the drip spike 102 and the alternate drip port 106. In accordance with standard specifications for a stopcock that rotates between three positions, the top surface 141 of the lever displays the word OFF, indicating to the healthcare provider a sealed port.

[0026] Edge 142 of flow control member lever main portion 138 faces flow control member port 103 and surrounds flow control member shaft 117. Edge 142 has an inward protrusion 143 that is one element of bung rotation limiting mechanism 124. Protrusion 143 has wall 143A adjacent to arcuate wall 133A, which prevents counterclockwise rotation of flow control member 116 relative to IV spike body 101 in the top perspective view of Figure 3. Protrusion 143 also has an opposite wall 143B adjacent to arcuate wall 133B, which prevents clockwise rotation of flow control member 116 in the final dispensing position in the top perspective view of Figure 3.

[0027] The flow control member lever edge 142 is provided with a pair of detent mechanisms 126 as follows: a first detent 144A snaps into groove 137 when the flow control member 116 is in the intermediate ready position, and a second detent 144B snaps into groove 137 when the flow control member 116 is in the final dispensing position. The second detent 144B snaps into place before the projection wall 143B contacts the arc portion wall 133B. The pair of detents 144 form an angle of approximately 45°, which corresponds to the angle that the flow control member 116 rotates from the intermediate ready position to the final dispensing position.

[0028] Flow control member shaft 117 includes a circumferential surface 146 and an end surface 147. End surface 147 is opposite flow control member lever 118. Shaft 117 includes a sloped preparation lumen 148 and a straight administration lumen 149. Preparation lumen 148 communicates between IV spike lumen 127 and vial adapter support lumen 129. Administration lumen 149 communicates between IV spike lumen 127 and alternate IV port holder lumen 128 intermediately therealong. Preparation lumen 148 and administration lumen 149 extend in the same cross-section and intersect with rotation axis 116A. Preparation lumen 148 includes an inlet 148A and an outlet 148B at shaft circumferential surface 146. The administration lumen 149 includes an inlet 149A and an outlet 149B on the shaft periphery 146. The angle of inclination of the preparation lumen 148 is approximately 135°, which is equal to the angle between the IV spike 102 and the vial adapter support 107, which is approximately 135°.

[0029] The flow control member shaft 117 includes a notch 151 that is aligned with the axis of rotation 116A and points toward the shaft end face 147. The shaft 117 includes a cantilevered latch detent 152 that is part of the latch mechanism 123. When the flow control member is in its initial position, the latch detent 152 is positioned within the latch hole 136 and flexes therefrom toward the axis of rotation 116A when the bottle adapter 108 is compressed, thereby allowing the flow control member 116 to be manually rotated. The latch detent 152 is located diametrically opposite the shaft from the detent 144A.

[0030] As shown in Figures 7A-7C, the bottle adapter inner body 109 has an inverted cup shape and includes an annular horizontal top wall 153 and a sleeve 154 that extends downwardly along the bottle crown. The sleeve 154 has a lower rim 154A. The bottle adapter inner body 109 defines a cavity 156 for the bottle crown. When the bottle adapter inner body 109 is snap-fitted onto the bottle crown 33 in a telescopic fashion, the bottle crown 33 fits snugly within the cavity 156. The horizontal top wall 153 has a central through-hole 153A that extends along the longitudinal centerline 108A of the bottle adapter. When the bottle adapter is snap-fitted onto the infusion bottle 30 in a telescopic fashion, the through-hole 153A covers the top surface 41 of the infusion bottle.

[0031] The main portion 157 of the sleeve 154 has a first pair 158A and a second pair 158B of adjacent longitudinal slits that form a pair of diametrically aligned bottle crown retaining members 159A, 159B. The bottle crown retaining members 159 are rotatable relative to the main portion 157 of the sleeve and each include a proximal end 161 and a distal end 162. The horizontal upper wall 153 of the bottle adapter inner body preferably includes a pair of diametrically aligned cutouts 163 that are located inside the bottle crown retaining members 159 to allow the bottle crown retaining members 159 to rotate on the horizontal upper wall 153.

[0032] Each of the distal ends 162 of the vial crown retaining members has a projection 164 that projects inwardly toward the lower edge 154A of the sleeve. When the vial adapter inner body 109 is initially snap-fitted like a telescope onto an intact, unpierced infusion vial 30, the projections 164 snap-fit ​​beneath the vial crown 33. When the proximal end 161 of the vial crown retaining member is pinched like a pair of pliers and compressed toward the longitudinal centerline 108A of the vial adapter, the vial crown retaining member 159 rotates relative to the main portion 157 of the sleeve. This moves the projections 164 of the vial crown retaining member away from the longitudinal centerline 108A of the vial adapter.

[0033] The horizontal top wall 153 of the bottle adapter inner body includes a pair of diametrically aligned, upstanding locking members 166 that are orthogonally aligned with the pair of bottle crown retaining members 159. The locking members 166 prevent accidental removal of the bottle adapter inner body 109 from the outer body 111. The sleeve 154 includes a pair of diametrically aligned clamping members 167 that extend toward the sleeve's lower edge 154A and are orthogonally aligned with the bottle crown retaining members 159. The locking members 166 and the clamping members 167 are components of the clamping mechanism 122.

[0034] The horizontal top wall 153 of the bottle adapter inner body has an upstanding latch release member 168. The latch release member 168 is one element of the latch mechanism 123. The latch release member 168 has a free end surface 168A. The latch release member 168 passes through the bottle adapter outer body 111 and is disposed within the latch hole 136. The latch release member's free end surface 168A is disposed within the latch hole 136 when the bottle adapter 108 is in the pre-compressed state and is flush with the central flow control member port 103 when the bottle adapter 108 is in the compressed state. When the bottle adapter 108 is in the compressed state, the latch release member 168 displaces the latch stop 152 from, i.e., out of, the latch hole 136, releasing the latch mechanism 123.

[0035] 8A-8C, the bottle adapter outer body 111 has the shape of an inverted cup and includes a horizontal top wall 171 and a downwardly facing skirt 172 with a lower lip 172A. The outer body 111 defines an inner body cavity 173 within which the inner body 109 fits snugly like a telescope, allowing the bottle adapter 108 to be compactly fitted from the pre-compressed to the compressed state.

[0036] The horizontal upper wall 171 of the vial adapter outer body includes the following parts: First, a centrally located upright connector 174 is inserted into the vial adapter support lumen sub-portion 129B and the downward-facing puncture cannula 112 located on the opposite side. When the vial adapter 108 is in a compressed state, the tip 112A of the puncture cannula 112 pierces the stopper 37 of the infusion vial. Second, a through-hole 176 belonging to the latch release member 168 allows the latch release member 168 to pass through. Third, a peripheral edge 177 is attached to the vial adapter flange 134. Fourth, a pair of diametrically aligned circumferential slits 178 receive the pair of base ends 161 of the vial crown retainer when the vial adapter 108 is in a compressed state. Fifth, a pair of diametrically aligned circumferential slits 179 receive the fixing member 166 when the vial adapter 108 is in a compressed state.

[0037] The skirt 172 of the vial adapter outer body includes a first pair of diametrically aligned longitudinal slits 181 and a second pair of slits 182. The second pair of slits 182 oppose the first pair of slits 181 and form vial adapter inner body retaining members 183A, 183B. A tuning fork-like safety catch 121 traverses the first pair of slits 181 and the second pair of slits 182 to prevent compression of the vial adapter 108.

[0038] The vial adapter inner body retaining members 183A, 183B have internal longitudinal cavities 184A, 184B. These cavities 184A, 184B have lower edges 186A, 186B. The retaining members 183A, 183B are components of the clamping mechanism 122.

[0039] The skirt 172 of the vial adapter outer body has a pair of diametrically aligned through-holes 187 for releasing the infusion bottle. These through-holes 187 are arranged perpendicular to the vial adapter inner body holding members 183A, 183B. The pair of through-holes 187 are used to pinch and compress an unpierced, intact infusion bottle with a hand tool 200 such as pliers, in a pliers-like manner, to remove the infusion bottle. This prevents the infusion bottle from being pinched and compressed by hand like a pliers.

[0040] A method of using the infusion device 100 will now be described with reference to Figures 9A-13B.

[0041] As shown in Figures 9A-9E, in the set configuration of the infusion device 100, a tuning-fork-like safety catch 121 traverses the vial adapter outer body 111, preventing compression of the vial adapter 108. The flow control member lever 118 indicates that the IV spike 102 is sealed. The latch mechanism 123 secures the stopper mechanism 114 in the initial set position by disposing the latch stopper 152 in the latch hole 136 (see Figure 9C). In the pre-compressed state, the vial adapter 108 has a height H1 between the horizontal upper wall 171 of the outer body and the lower edge 154A of the sleeve. A through-hole 187 for releasing the infusion vial is aligned with the proximal end 161 of the vial crown retainer.

[0042] The healthcare provider removes the cap 42 from the unpunctured, intact infusion bottle 30 and wipes the exposed top surface 41 of the infusion bottle. The healthcare provider then telescopes the bottle adapter 108 onto the infusion bottle 30 so that the infusion solution can be prepared in the infusion solution container 20 for administration to the patient. If medication administration is to be discontinued and the unpunctured, intact infusion bottle 30 is to be reused, the healthcare provider follows the following steps, as shown in Figures 10A and 10B.

[0043] The healthcare provider aligns a pliers-like hand tool 200 with the vial adapter 108 and inserts the pair of inward projections 203 into the pair of through-holes 187 for releasing the infusion vial. The healthcare provider squeezes the proximal ends 161 of the vial crown retaining members with the pliers, moving them toward the longitudinal centerline 108A of the vial adapter. The vial crown retaining members 159 rotate relative to the sleeve main portion 157, moving the inner circumferential projections 164 away from the longitudinal centerline 108A of the vial adapter, releasing the unpunctured and intact infusion vial 30. The healthcare provider removes the infusion vial 30 from the vial adapter inner body 109 and prepares it for subsequent use, regardless of whether the cap 42 has been removed. The infusion device 100 is then discarded.

[0044] 11A-11C show the infusion device 100 after a healthcare provider has removed the safety catch 121 from the vial adapter's outer body 111. The outer body 111 fits snugly around the inner body 109, allowing the vial adapter 108 to fit compactly. When the needle cannula tip 112A pierces the sheath 113, the infusion vial stopper 37 opens a fluid path between the needle cannula 112 and the vial body 32, allowing the infusion fluid to be prepared. In the compressed state, the vial adapter 108 has a height H2 between the outer body's horizontal upper wall 171 and the sleeve's lower edge 154A, where H1 > H2. When the vial adapter 108 is compressed, the latch release member 168 disengages the latch stopper 152 from the latch hole 136, unlatching the latch mechanism 123. The stopper mechanism 114 remains in its initial position. The compression makes it impossible to remove the punctured infusion vial 30 using a hand tool 200 such as pliers.

[0045] 12A and 12B show the infusion device 100 after the healthcare provider has rotated the flow control member 116 approximately 180° relative to the drip spike body 101 to an intermediate, ready position. The flow control member lever 118 indicates that the alternate drip port 106 is sealed. The healthcare provider hears a click as the detent 144A strikes the groove 137. The drip spike 102 communicates with the needle cannula 112 through the preparation lumen 148. The healthcare provider primes the drip bag 20 with the infusion fluid by inserting the drip spike 102 into the drip port 21 of the drip bag 20 and transferring the liquid contents back and forth between the drip bag 20 and the infusion bottle 30. The healthcare provider preferably delivers the liquid contents to ensure that the infusion bottle 30 is eventually emptied.

[0046] 13A and 13B show the infusion device 100 after the healthcare provider has rotated the flow control member 116 approximately 45° relative to the drip spike body 101 to its final dispensing position. The flow control member lever 118 indicates that the vial adapter 108 is sealed. The healthcare provider hears a click as detent 144B strikes groove 137. The bung rotation limiting mechanism 124 prevents further rotation of the flow control member 116. The drip spike 102 communicates with the alternate drip port 106 through the dispensing lumen 149. The healthcare provider opens the alternate drip port 106 and inserts the drip spike 51 of the infusion set therein to administer the infusion fluid.

[0047] 14-19C show an infusion device 300 according to a second embodiment of the invention. FIG. 14 also shows a pliers-like hand tool 200 for removing an unpierced, intact infusion bottle 30. The hand tool 200 includes a pliers-like body 201 and a pair of claws 202. Each of the claws 202 includes an inward protrusion 303 at its end. The pair of claws 202 can be manually moved toward each other to pinch, compress, and remove the unpierced, intact infusion bottle 30 like a pair of pliers, as will be described below with reference to FIGS. 21A and 21B.

[0048] Infusion device 300 includes an IV spike body 301, a flow control member 302, a telescoping vial adapter 303, and an inverted T-shaped seal member 304. IV spike body 301 has a longitudinal centerline 301A. Vial adapter 303 has a longitudinal centerline 303A. Vial adapter 303 includes an inner body 306 and an outer body 307. Infusion device 300 includes the following components: Safety catch mechanism 308 prevents a user from accidentally compressing the vial adapter to transition from an initial pre-compressed state to a final compressed state. Safety catch mechanism 308 is embodied as a tuning fork-like safety catch 309. When vial adapter 303 is in the initial pre-compressed state, safety catch 309 extends horizontally through the outer body 307 of the vial adapter. Clamping mechanism 311 irreversibly clamps vial adapter 303 in the compressed state. A stopcock 312, which rotates between three positions, controls the direction of flow through the infusion device 300 when the vial adapter 303 is in a compressed state. A latch mechanism 313 prevents manipulation of the stopcock 312 when the vial adapter 303 is in a pre-compressed state. A stopcock position icon display mechanism 314 displays an icon indicating the stopcock position to indicate the direction of flow through the infusion device 300.

[0049] As shown in Figures 16A-16C, the drip spike body 301 is trifurcated and includes an drip spike 316 on one side, a tubular flow control member port 317 in the center, and a tubular alternate drip port holder 318 on the other side. The drip spike 316 is inserted into and sealed with the drip port 21. The flow control member port 317 receives and seals the flow control member 302. The alternate drip port holder 318 receives and seals the alternate drip port 319. The alternate drip port 319 can be incorporated as a threaded or broken-off part. The flow control member port 317 is formed by a downward-facing cap 321 of the vial adapter, which is secured to the vial adapter 303 with a snap fit. The drip spike 316, flow control member port 317, and alternate drip port holder 318 allow flow to pass continuously in three directions.

[0050] The vial adapter cap 321 has a horizontal upper wall 322 and a lower lip 323. The horizontal upper wall 322 has an inner surface 322A that includes a pair of diametrically aligned latch holes 324A, 324B, which are components of the latch mechanism 313 and prevent relative rotation between the IV spike body 301 and the vial adapter 303 when the vial adapter 303 is in a pre-compressed state.

[0051] The inner surface 322A of the horizontal upper wall of the vial adapter cap includes a pair of diametrically aligned rows of holes 326A, 326B. These determine the location of the stopper and are part of the stopper 312 that determines the flow of the infusion device 300. Each row of holes 326 includes an initial blocking hole 327, an intermediate priming hole 328, and a final dosing hole 329. The blocking hole 327 includes a chamfered first surface 327A. This first surface 327A allows the stopper 312 to move smoothly from the initial blocking position to the intermediate priming position. The priming hole 328 includes a chamfered first surface 328A. This first surface 328A allows the stopper 312 to move smoothly from the intermediate priming position to the final dosing position. The priming hole 328 includes a non-chamfered second surface 328B that prevents the stopper 312 from moving back from the intermediate priming position to the initial blocking position. Dispensing hole 329 includes a chamfered second surface 329A. Second surface 329A allows stopper 312 to move smoothly from the final dispensing position to the intermediate ready position, even if a healthcare provider accidentally rotates stopper 312 directly from the initial blocking position to the final dispensing position without preparing the infusion. Thus, the healthcare provider can place stopper 312 in the intermediate ready position and prepare the infusion.

[0052] The lower edge 323 of the bottle adapter has a pair of diametrically aligned bung position icon display windows 331, which are one element of the bung position icon display mechanism 314. The inner surface 322A of the horizontal upper wall of the bottle adapter cap has a pair of diametrically aligned screens 332 inside the bung position icon display windows 331. The screens 332 have a constant radius and widen downward. The screens 332 are also one element of the bung position icon display mechanism 314.

[0053] As shown in FIG. 17 , flow control member 302 has a substantially cylindrical body 333 including a top surface 334, a peripheral surface 336, and a bottom surface 337. Flow control member 302 includes an L-shaped lumen 338 within the interior thereof, which is utilized for preparation of the infusion fluid. L-shaped lumen 338 includes an IV spike opening 338A in peripheral wall 336 and a needle cannula opening 338B in bottom surface 337. Peripheral wall 336 of the flow control member includes a circumferential groove 339, which is utilized for administration of the infusion fluid. External groove 339 includes an IV spike opening 339A and an alternative IV port opening 339B. Bottom surface 337 of the flow control member includes a keyway 341 that mechanically engages vial adapter 303. Keyway 341 allows flow control member 302 and vial adapter 303 to rotate together relative to IV spike body 301.

[0054] As shown in Figures 18A and 18B, the bottle adapter inner body 306 has an inverted cup shape and includes an annular horizontal upper wall 342 and a sleeve 343. The sleeve 343 has a lower lip 343A that flares downward to fit over the bottle crown. The bottle adapter inner body 306 defines a bottle crown cavity 344 within which the bottle crown 33 fits snugly and is secured thereon by a telescopic snap fit. The bottle adapter inner body's horizontal upper wall 342 has a through-hole 342A in the center, aligned along the bottle adapter's longitudinal centerline 303A. When the bottle adapter inner body is secured over the infusion bottle 30 by a telescopic snap fit, the through-hole 342A overlies the top surface 41 of the infusion bottle.

[0055] The sleeve 343 includes a main portion 346 having a first pair of slits 347A and a second pair of slits 347B. The slit pairs 347A, 347B extend longitudinally and define a pair of diametrically aligned bottle crown retaining members 348A, 348B. The bottle crown retaining members 348 are rotatable relative to the sleeve main portion 346 and include a proximal end 349 and a distal end 351. The horizontal top wall 342 of the bottle adapter inner body preferably includes a pair of diametrically aligned notches 352 on the interior side of the bottle crown retaining members 348. The notches 352 allow the bottle crown retaining members 348 to rotate relative to the horizontal top wall 342.

[0056] Each of the tip portions 351 of the bottle crown retaining members is provided with an inner circumferential projection 353. The projections 353 protrude toward the lower edge 343A of the sleeve and are secured by a snap fit under the bottle crown 33 when the inner body 302 of the bottle adapter is secured by a snap fit onto an unpierced, intact infusion bottle 30. When the base end 349 of the bottle crown retaining member is compressed toward the longitudinal center line 303A of the bottle adapter using pliers, the bottle crown retaining member 348 rotates relative to the main portion 346 of the sleeve, and the projections 353 of the bottle crown retaining member move away from the longitudinal center line 303A of the bottle adapter.

[0057] The horizontal top wall 342 of the bottle adapter inner body includes a pair of diametrically aligned, upstanding catches 354. The catches 354 are positioned perpendicular to the bottle crown retaining member 348. The catches 354 prevent the bottle adapter inner body 306 from being accidentally removed from the outer body 307. The sleeve 343 includes a pair of diametrically aligned clamping members 356. The clamping members 356 are positioned toward the sleeve's lower edge 343A and are positioned perpendicular to the bottle crown retaining member 348. The clamping members 356 are one element of the clamping mechanism 311.

[0058] The horizontal top wall 342 of the bottle adapter inner body has a pair of diametrically aligned, upstanding latch members 357 that release the latch from the latch mechanism 313 when the bottle adapter 303 is in a compressed state. The latch members 357 are disposed perpendicular to the bottle crown retaining member 348.

[0059] 19A-19C, the bottle adapter outer body 307 has the shape of an inverted cup and includes a horizontal top wall 358 and a downwardly facing skirt 359 with a lower lip 359A. The bottle adapter outer body 307 defines an inner body cavity 361. When the bottle adapter 303 collapses from the pre-compressed state to the compressed state, the inner body 306 telescopes into the cavity 361 of the outer body 307.

[0060] The horizontal top wall 358 of the vial adapter outer body includes a downwardly facing puncture cannula 361. The puncture cannula 361 has a proximal opening 361A and a distal end 361B. The horizontal top wall 358 includes a box-shaped key 362. The key 362 is inserted into the keyhole 341 of the flow control member. The key 362 is integral with the proximal opening 361A of the puncture cannula. The distal end 361B of the puncture cannula pierces the stopper 37 of the infusion vial when the infusion device 300 is in a compressed state.

[0061] Downward skirt 359 includes a first pair of longitudinally extending slits 363A and a second pair of slits 363B. These slit pairs define a pair of diametrically aligned inner body retaining members 364A, 364B. Inner body retaining members 364A, 364B include longitudinal holes 366A, 366B on their interior sides. Inner body retaining members 364A, 364B are components of fastening mechanism 311. The longitudinal holes 366A, 366B include a pair of diametrically aligned lips 367A, 367B on their undersides. When vial adapter 303 is in a pre-compressed state, a tuning fork-like safety catch 309 traverses first pair of slits 363A and second pair of slits 363B, preventing vial adapter 303 from being compressed.

[0062] The horizontal top wall 358 of the bottle adapter outer body includes a pair of diametrically aligned horizontal latch members 368A, 368B. The horizontal latch members 368A, 368B include central pivots 369A, 369B, allowing them to move like a seesaw relative to the horizontal top wall 358. This movement positions the horizontal latch members 368A, 368B in an initial latched position, latching the latch mechanism 313 when the bottle adapter 303 is in a pre-compressed state, and in a final unlatched position, releasing the latch mechanism 313 when the bottle adapter 303 is in a compressed state. Each of the horizontal latch members 368A, 368B has a first end 371A and an opposite second end 371B. A latch stop 372 extends upstanding from the first end 371A. When horizontal latch members 368A, 368B are in the unbent position, latch stop 372 projects above horizontal top wall 358 relative to the latched position and is inserted into latch hole 324. When bottle adapter 303 is in a compressed state, upright latch member 357 acts on horizontal latch member second end 371B to rotate horizontal latch members 368A, 368B and move latch stop 372 out of latch hole 324 to a final, unlatched position.

[0063] The horizontal top wall 358 of the vial adapter outer body includes a pair of diametrically aligned, horizontal, cantilevered bung members 373A, 373B that are perpendicular to the horizontal latch members 368A, 368B. Each bung member 373A, 373B has an upstanding bung stopper 374 that mechanically engages the bung positioning hole array 326.

[0064] Peripheral wall 376 extends upright from vial adapter outer body 307 and surrounds horizontal top wall 358. Peripheral wall 376 is positioned between the lower edge 323 of the vial adapter and downward-facing screen 332 and is a component of bung position icon display mechanism 314. Peripheral wall 376 includes a pair of diametrically aligned bung position icon columns 377A, 377B, which indicate the flow status of infusion device 300. Bung position icon columns 377A, 377B are implemented as through-holes in peripheral wall 376. Each bung position icon column 377A, 377B includes three icons: a shutoff icon 378 implemented as an X-shape, a ready icon 379 implemented as a pair of opposing arcs, and a dose icon 381 implemented as a straight line.

[0065] Downward skirt 359 includes a pair of diametrically aligned through-holes 382A, 382B for removal of the infusion vial and aligned perpendicular to inner body retaining members 364A, 364B. Through-holes 382A, 382B allow hand tool 200, such as pliers, to squeeze and remove an intact, unpunctured infusion vial 30, but not by hand.

[0066] The seal member 304 includes a tube 383 that attaches to the puncture cannula 361 and a flat base plate 384. The base plate 384 is positioned in a through-hole 342A that opens centrally in the horizontal upper wall of the vial adapter's inner body when the vial adapter 303 is in a pre-compressed state. The central portion of the base plate 384 functions as a septum 386 that keeps the tip 361B of the puncture cannula sterile. When the infusion device 300 is mounted on the infusion vial 30 like a telescope, the base plate 384 rests on and seals the top surface 41 of the infusion vial. The septum 386 is pierced by the tip 361B of the puncture cannula when the vial adapter 303 is in a compressed state.

[0067] The method of using the infusion device 300 will now be described with reference to Figures 20A-24B.

[0068] FIG. 20A shows the setup configuration after the infusion device 300 is attached to the IV bag 20 and the vial adapter 303, in its initial pre-compressed state, is snap-fit ​​onto the infusion vial 30. A tuning-fork-like safety catch 309 traverses the vial adapter's outer body 307, preventing the vial adapter 303 from being compressed. A hole 382A for releasing the infusion vial is aligned with the proximal end 349 of the vial crown retainer. A latch mechanism 313 secures the stopper 312 in the initial shut-off position. As shown in FIG. 20B, the stopper position icon display mechanism 314 displays a shut-off icon 378 "X" in the stopper position icon display window 331. In the vial adapter 303, the distance between the horizontal upper wall 358 of the outer body and the lower edge 343A of the sleeve is equal to the height H1 in the pre-compressed state.

[0069] If the healthcare provider decides not to administer the medication and to reuse the unpunctured, intact infusion vial, the healthcare provider follows the following steps, as shown in Figures 21A and 21B. The healthcare provider aligns a pliers-like hand tool 200 with the vial adapter 303 and inserts the inward projections 203 into the vial release holes 382. The healthcare provider squeezes the proximal ends 349 of the vial crown retaining members with the pliers and moves them toward the vial adapter's longitudinal centerline 303A, as shown by arrow A. Rotation of the vial crown retaining member 348 relative to the sleeve main portion 346 moves the vial crown retaining member's inner circumferential projections 353 away from the vial adapter's longitudinal centerline 303A, as shown by arrow B, releasing the unpunctured, intact infusion vial 30. The healthcare provider then removes the vial from the vial adapter's inner body 306, as shown by arrow C, and prepares it for subsequent use, regardless of the removal of the cap 42. Meanwhile, the infusion device 300 is discarded.

[0070] 22A and 22B show the infusion device 300 after a healthcare provider has removed the safety catch 309 from the vial adapter outer body 307. The vial adapter 303 is retracted, with the outer body 307 of the vial adapter 303 snugly nesting the inner body 306 within it. After the tip 361B of the puncture cannula pierces the septum 386 of the seal member, a flow path is opened between the puncture cannula 361 and the vial body 32 in the infusion vial stopper 37 for preparing the infusion fluid. The vial adapter 303 has a height H2 in its compressed state between the horizontal upper wall 358 of the outer body and the lower edge 343A of the sleeve, where H1 > H2. When the vial adapter 303 is compressed, the upright latch member 357 abuts the second end 371B, rotating the horizontal latch member 368 to the unlatched position, thereby unlatching the latch mechanism 313. Because the stopper 312, which rotates among the three positions, remains in the initial shut-off position, the stopper position icon display mechanism 314 continues to display the ready icon 378 "X" in the stopper position icon display window 331 (see FIG. 22A). Because the vial adapter is compressed, the infusion vial 30 cannot be removed even with a hand tool 200 such as pliers.

[0071] 23A and 23B show the infusion device 300 after the healthcare provider has rotated the IV spike body 301 relative to the vial adapter 303, rotating the stopper 312 to the intermediate, ready position. In this position, the cantilevered stopper member 373 has rotated from the blocking hole 327 to the ready hole 328. The L-shaped lumen 338 within the flow control member communicates with the IV spike 316 and the needle cannula 361. As shown in FIG. 23A, the stopper position icon display mechanism 314 displays a ready icon 379, “two opposing arcs,” in the stopper position icon display window 331. The healthcare provider prepares the infusion fluid in the IV bag 20 by transferring the liquid contents back and forth between the IV bag 20 and the infusion vial 30.

[0072] 24A and 24B show the infusion device 300 after the healthcare provider has rotated the drip spike body 301 relative to the vial adapter outer body 303 to move the stopper 312 to its final dispensing position. In this position, the cantilevered stopper member 373 has rotated from the preparation hole 328 to the dispensing hole 329. The flow control member's circumferential groove 339 communicates with the drip spike 316 and the alternate drip port 318. As shown in FIG. 24A, the stopper position icon display mechanism 314 displays the dispensing icon 381, a "straight line," in the stopper position icon display window 331. The healthcare provider opens the alternate drip port 318 and inserts the infusion set's drip spike 51 into the alternate drip port 318 to administer the infusion fluid.

[0073] 25-29C show an infusion device 400 according to a third embodiment of the invention. The infusion device 400 includes a three-pronged, Y-shaped drip spike body 401. The drip spike body 401 has a longitudinal centerline 401A. The drip spike body 401 includes an drip spike 402 on one side, a flow control member port 403 in the center, and an alternate drip port holder 404 on the other side. The alternate drip port holder 404 receives and seals an alternate drip port 406. The flow control member port 403 has an axis 416A that intersects the longitudinal centerline 401A of the drip spike body. The alternate drip port 406 may be incorporated as a threaded or broken-off part. The drip spike 402 and the alternate drip port holder 404 are oriented in the same direction and are aligned with the longitudinal centerline 401A of the drip spike body. The drip spike body 401 includes a bottle adapter support 407. The bottle adapter support 407 extends from the flow control member port 403 and is inclined at approximately 135° relative to the drip spike 402 and approximately 45° relative to the alternate drip port 404 in the top perspective view shown in FIG. 25. The infusion device 400 includes a bottle adapter 408 attached to the bottle adapter support 407. The bottle adapter 408 may be firmly, permanently, or removably attached to the bottle adapter support 407. The bottle adapter 408 has a longitudinal centerline 408A that intersects the longitudinal centerline 401A of the drip spike body. The bottle adapter 408 includes a puncture cannula 412 (see FIGS. 29A-29C). The puncture cannula 412 pierces the stopper 37 of the infusion bottle. Needle cannula 412 is protected by a thin sheath (not shown) to keep it sterile until infusion device 400 is used to administer the infusion fluid.

[0074] The infusion device 400 includes a stopcock mechanism 414 that can be manually rotated between three positions. The stopcock mechanism 414 includes an L-shaped flow control member 416. The flow control member 416 rotates clockwise relative to the drip spike body 401, as indicated by arrow A in the top perspective view of FIG. 25. The flow control member 416 has an axis of rotation 416A that is perpendicular to the longitudinal centerline 401A of the drip spike body. The flow control member 416 includes a shaft 417 and a lever 418. The shaft 417 is tightly inserted and sealed into the flow control member port 403. The lever 418 is rotated by being held between the healthcare provider's thumb and index finger. The stopcock mechanism 414 controls the flow of the infusion device 400. In the top perspective view of FIG. 25, the stopcock mechanism 414 rotates the flow control member 416 clockwise from an initial set position, through an intermediate ready position, to a final administration position. In the ready position, the infusion is prepared, and in the administering position, the infusion is administered to the patient. The stopcock mechanism 414 seals the drip spike 402 in the set position, the alternate drip port 406 in the ready position, and the bottle adapter 408 in the administering position.

[0075] The infusion device 400 includes the following parts: A bung rotation limiting mechanism 424 prevents the healthcare provider from further rotating the flow control member 416 beyond the final dispensing position. A detent mechanism 426 generates an audible alarm when the flow control member 416 is rotated from the initial set position to the intermediate ready position and when the flow control member 416 is rotated from the intermediate ready position to the final dispensing position. The audible alarm is preferably a click as the detent engages with the groove, and is heard twice by the healthcare provider during operation of the infusion device 400. Thus, the detent mechanism 426 may include a single groove and a pair of detents, or may include a single detent and a pair of grooves.

[0076] 27A-27E show that the drip spike 402 has a lumen 427 that communicates with the flow control member port 403, and the alternate drip port holder 404 has a lumen 428 that is collinear with the drip spike lumen 427 and communicates with the flow control member port 403. The vial adapter support 407 includes a lumen 429 that communicates with the flow control member port 403. The lumen 429 is stepped, dividing it into a narrower main section 429A that is closer to the flow control member port 403 and a wider secondary section 429B that is further from the flow control member port 403.

[0077] Flow control member port 403 includes a first edge 431 on one side and a second edge 432 on the opposite side. First edge 431 is stepped and is one element of bung rotation limiting mechanism 424. First edge 431 includes a protruding arc portion 433. Arc portion 433 has an arc length of approximately 135°, limiting rotation of flow control member 416 about rotation axis 416A to approximately 225° from the initial set position to the final dispense position. Arc portion 433 includes a wall 433A and an opposing wall 433B.

[0078] Bottle adapter support 407 terminates in a flange 434 that attaches to bottle adapter 408 .

[0079] 28A-28F, the flow control member lever 418 includes a substantially rectangular main portion 438 and an elongated secondary portion 439 that is held between the healthcare provider's thumb and index finger. The top surface 441 of the lever 418 faces away from the flow control member port 403 and includes symbols indicating the flow paths of the infusion device 400 during operation. The flow paths include a priming flow path between the drip spike 402 and the bottle adapter 408 and an administration flow path between the drip spike 402 and the alternate drip port 406. In accordance with standard specifications for a stopcock that rotates between three positions, the top surface 441 of the lever displays the word OFF to indicate a sealed port to the healthcare provider.

[0080] Edge 442 of flow control member lever main portion 438 faces flow control member port 403 and surrounds flow control member shaft 417. Edge 442 has an inwardly directed projection 443 that is one element of bung rotation limiting mechanism 424. Projection 443 has wall 443A adjacent to arcuate wall 433A, which prevents counterclockwise rotation of flow control member 416 relative to drip spike body 401 in the top perspective view of FIGURE 25. Projection 443 also has an opposite wall 443B adjacent to arcuate wall 433B, which prevents clockwise rotation of flow control member 416 in the final dispensing position in the top perspective view of FIGURE 25.

[0081] The flow control member lever edge 442 is provided with a pair of detent mechanisms 426 as follows: a first detent 444A snaps into groove 437 when the flow control member 416 is in the intermediate ready position, and a second detent 444B snaps into groove 437 when the flow control member 416 is in the final dispensing position. The second detent 444B snaps into place before the inward projection wall 443B contacts the arc portion wall 433B. The pair of detents 444 form an angle of approximately 45°, which corresponds to the angle of rotation of the flow control member 416 from the intermediate ready position to the final dispensing position.

[0082] Flow control member shaft 417 includes a circumferential surface 446 and an end surface 447. End surface 447 is opposite flow control member lever 418. Shaft 417 includes a sloped preparation lumen 448 and a straight administration lumen 449. Preparation lumen 448 communicates between IV spike lumen 427 and vial adapter support lumen 429. Administration lumen 449 communicates between IV spike lumen 427 and alternate IV port holder lumen 428 intermediately therealong. Preparation lumen 448 and administration lumen 449 are disposed in the same cross-section and intersect with rotation axis 416A. Preparation lumen 448 includes an inlet 448A and an outlet 448B on shaft circumferential surface 446. The administration lumen 449 includes an inlet 449A and an outlet 449B on the shaft periphery 446. The angle of inclination of the preparation lumen 448 is approximately 135°, which is equal to the angle between the IV spike 402 and the vial adapter support 407, which is approximately 135°.

[0083] The flow control member shaft 417 includes a notch 451. The notch 451 is aligned with the axis of rotation 416A and faces toward the end face 447 of the shaft.

[0084] As shown in Figures 29A-29C, the bottle adapter body 408 has an inverted cup shape and includes a horizontal top wall 471 and a vertical slit 458. The slit 458 defines flexible bottle crown retaining members 459. The bottle adapter body 408 defines a cavity 456 within which the bottle crown 33 is snugly received. Each bottle crown retaining member 459 includes an inwardly projecting projection 464 at its tip. The projections 464 snap into place beneath the bottle crown 33 when the bottle adapter body 408 is snap-fit ​​onto an intact infusion bottle 30.

[0085] The horizontal upper wall 471 of the bottle adapter body includes a central, upstanding connector 474 and a downward-facing puncture cannula 412 on its opposite side. The connector 474 is inserted into the sub-portion 429B of the vial adapter support lumen. The tip 412A of the puncture cannula 412 pierces the infusion bottle stopper 37 when the bottle adapter body is snap-fit ​​onto the intact infusion bottle 30. The horizontal upper wall 471 of the bottle adapter body also includes a circumferential lip 477 that attaches to the bottle adapter flange 434.

[0086] A method for using the infusion device 400 will now be described with reference to Figures 30A-32B.

[0087] 30A-30C show the setup configuration of the infusion device 400. The flow control member lever 418 indicates that the drip spike 402 is sealed (i.e., blocked). The healthcare provider removes the cap 42 from the intact, unpunctured infusion bottle 30 and wipes the exposed top surface 41 of the infusion bottle. The healthcare provider attaches the bottle adapter 408 onto the infusion bottle 30 so that the infusion fluid can be prepared in the infusion fluid container 20 and administered to the patient. When the healthcare provider attaches the bottle adapter 408 onto the infusion bottle 30, the tip 412A of the puncture cannula pierces the sheath and subsequently the stopper 37 of the infusion bottle. This opens a flow path between the puncture cannula 412 and the bottle body 32 for preparing the infusion fluid.

[0088] 31A and 31B show the infusion device 400 after the healthcare provider has rotated the flow control member 416 approximately 180° relative to the drip spike body 401 to the ready position. The flow control member lever 418 indicates that the alternate drip port 406 is sealed. The healthcare provider hears a click as the detent 444A strikes the groove 437. The drip spike 402 communicates with the needle cannula 412 through the priming lumen 448. The healthcare provider primes the drip bag by inserting the drip spike 402 into the drip port 21 of the drip bag 20 and transferring liquid contents back and forth between the drip bag 20 and the infusion bottle 30. The healthcare provider preferably ensures that the infusion bottle 30 is empty upon the final transfer of liquid contents.

[0089] 32A and 32B show the infusion device 400 after the healthcare provider has rotated the flow control member 416 approximately 45° relative to the drip spike body 401 and moved it to the dispensing position. The flow control member lever 418 indicates that the vial adapter 408 is sealed. The healthcare provider hears a click as the detent 444B strikes the groove 437. The bung rotation limiting mechanism 424 prevents further rotation of the flow control member 416. The drip spike 402 communicates with the alternate drip port 406 through the dispensing lumen 449. The healthcare provider opens the alternate drip port 406 and inserts the drip spike 51 of the infusion set therein to administer the infusion fluid.

[0090] All of the embodiments described in accordance with Figures 3-32B include three rotational positions: an initial set position in which the drip spike is sealed; an intermediate preparation position in which communication is established between the drip spike and the needle cannula to prepare (i.e., mix) the infusion fluid; and a final administration position in which communication is established between the drip spike and the alternate drip port to administer the infusion fluid. In another embodiment, there may be two rotational positions: a mixing or reconstitution position (i.e., initial position) in which communication is established between the drip spike and the needle cannula; and an administration position (i.e., final position) in which communication is established between the drip spike and the alternate drip port holder. In this another embodiment, the infusion device is set to an initial position or state in which communication is established between the drip spike and the needle cannula. Additionally, a larger arc portion (see arc portions 133, 433) is provided to limit movement of the flow control member between the two positions. For example, the arc length of the arc segment may be set to about 45°. For example, the movement of the flow control member may be limited between the positions shown in Figures 12A and 13A. Alternatively, each of the rows of holes 326 defining the bung positions may include only two holes, i.e., mixing hole 328 and dosing hole 329.

[0091] While particular embodiments of the present invention 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 invention.

[0092] An infusion device has been described above and is illustrated in the accompanying drawings. The infusion device is used with an infusion container containing an infusion solution and includes an infusion port for administering the infusion solution. A separate infusion bottle, initially unpierced and intact, has a closed-end vial body containing the medication, a tubular crown, and a top. The crown has an opening capped by an unpierced stopper. The infusion set includes an infusion spike that is inserted into and sealed to the infusion port, and a connector intended for administration to a patient.

[0093] The following is a non-exhaustive list of numbered aspects of the invention that may be claimed.

[0094] 1. A bottle adapter including a puncture cannula for puncturing the stopper of an infusion bottle; With an IV spike, an alternative infusion port holder for accommodating an alternative infusion port; a flow control member port in communication with the infusion spike, the alternative infusion port holder, and the puncture cannula; a flow control member inserted into the flow control member port and sealed; An infusion device comprising: Flow within the infusion device is controlled by rotating the flow control member between a plurality of positions, the plurality of positions including: a mixing or reconstitution position that allows flow between the drip spike and the needle cannula; An infusion device including an infusion spike and a dosing location that allows flow between an alternate infusion port holder.

[0095] 2. The infusion device of aspect 1, wherein the multiple positions include a sealing position that seals the drip spike or a position that blocks flow between the drip spike, the puncture cannula, and the alternate drip port.

[0096] 3. A detent mechanism that sounds an alarm when the flow control member rotates from the initial position to the intermediate position and from the intermediate position to the final position. The infusion device according to aspect 1 or 2, further comprising:

[0097] 4. The detent mechanism A pair of detents that fit into a single groove, or a single detent that fits into a pair of grooves 4. The infusion device of aspect 3, comprising:

[0098] 5. A rotation limiting mechanism that limits the rotation of the flow control member from the initial position to the final position. An infusion device as described in any one of aspects 1 to 4, comprising:

[0099] 6. The bottle adapter an inner body including a cavity for receiving a bottle crown; an outer body that slides into and receives the inner body when the bottle adapter is compressed from the pre-compressed state to the compressed state; An infusion device according to any one of aspects 1 to 5, comprising:

[0100] 7. Safety catch mechanism positioned to prevent accidental compression of bottle adapter 7. The infusion device according to aspect 6, comprising:

[0101] 8. An intravenous spike body configured to receive a bottle adapter, the intravenous spike body including a cap-shaped horizontal upper wall on which the body of the flow control member is formed. An infusion device as described in any one of aspects 1 to 7, comprising:

[0102] 9. The infusion device according to aspect 8, which is dependent on aspect 6 or aspect 7, the horizontal upper wall of the drip spike body includes a latch hole; a cap-shaped horizontal top wall of the bottle adapter outer body including a rotatable horizontal latch member; the latch member includes a first end and an opposite second end; a first end of the latch member including an upstanding latch stop; The latch member has: When the bottle adapter is in a pre-compressed state, the latch stop projects beyond the horizontal upper wall into the latch hole, preventing rotation of the flow control member in a non-flexed position. There are The inner body of the bottle adapter is an upstanding latch release member that acts on the second end of the latch member when the bottle adapter is compressed to rotate the latch member and move the latch stop from the latch hole to permit rotation of the flow control member; 12. An infusion device comprising:

[0103] 10. The horizontal top wall includes a row of positioning holes, the row of holes including an initial hole, an intermediate hole, and a final hole; The bottle adapter a cantilevered member including an upstanding position stop that mechanically engages the array of holes; 10. The infusion device according to aspect 8 or 9, having:

[0104] 11.The initial holes are: a chamfered first surface that allows the flow control member to move smoothly from the initial position to the intermediate position; Including, The intermediate hole is A chamfered first surface that allows the flow control member to move smoothly from the intermediate position to the final position Including, The intermediate hole is a second, non-chamfered surface to prevent the flow control member from returning from the intermediate position to the initial position; Including, The final hole is A chamfered second surface that allows the flow control member to move smoothly from the final position to the intermediate position 11. The infusion device of aspect 10, comprising:

[0105] 12. A position icon display mechanism configured to display the initial, intermediate, and final positions of the flow control member. An infusion device as described in any one of aspects 8 to 11, comprising:

[0106] 13. The drip spike itself is A lower lip of the cap shape configured to receive a bottle adapter Including, The edge includes a location icon display window; The bottle adapter an upper wall of the outer body including an array of location icons configured to be displayed in the location icon display window; 13. The infusion device of aspect 12, having:

[0107] 14. The location icon column is Three icons containing the letter X, a pair of opposing arcs, and a straight line 14. The infusion device of aspect 13, comprising:

[0108] 15. When the flow control element is in the initial position, the letter X appears in the icon display window; When the flow control member is in the intermediate position, a pair of arcs is displayed in the icon display window, When the flow control element is in the final position, a straight line is displayed in the icon display window. An infusion device as described in aspect 14.

Claims

1. an IV spike configured to be inserted into an IV bag; Alternative IV port holder, a bottle adapter support; Flow control member port and a three-pronged drip spike body including a bottle adapter including a puncture cannula for piercing a stopper of an infusion bottle, the bottle adapter being supported by the bottle adapter support; an alternative infusion port housed in the alternative infusion port holder; a flow control member housed in the flow control member port and configured to move to a mixing position that allows flow between the needle cannula and the drip spike, and to an administration position that allows flow between the needle spike and the alternate drip port holder and seals the needle cannula; An infusion device comprising: the alternate IV port holder extends in the same line as the IV spike; The needle cannula is inclined at an angle greater than 90° relative to the drip spike. An infusion device characterized by:

2. 2. The infusion device of claim 1, wherein the flow control member seals the alternate infusion port holder in the mixing position.

3. The flow control member is a sloped preparation lumen communicating the needle cannula with the drip spike at the mixing position; Including, The infusion device according to claim 1 or 2.

4. 4. The infusion device of claim 3, wherein the preparation lumen extends perpendicular to the axis of rotation of the flow control member.

5. The flow control member is a straight administration lumen communicating the IV spike with the alternate IV port holder at the administration location; Including, An infusion device according to any one of claims 1 to 4.

6. 6. The infusion device of claim 1, wherein the administration lumen extends perpendicular to the axis of rotation of the flow control member.

7. the flow control member port is an arcuate portion configured to limit rotation of the flow control member; 7. An infusion device according to any one of claims 1 to 6, comprising:

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