Multi-component adapter assembly for bulk medical fluid containers

Abstract

A medical container assembly is disclosed that has an adapter assembly that is fluidically connected to a medical container having a volume of medical fluid to accommodate multiple injections. The adapter assembly includes a spike assembly (300) that is fluidically connected to the medical container and a spike interface cap (200) that is detachably connected to the spike assembly (300). The spike assembly (300) incorporates features to reduce the likelihood that the spike assembly (300) will be used with multiple medical containers. The spike interface cap (200) is detachably connected to the spike assembly (300) and includes features that allow the spike interface cap (200) to be used with a spike assembly (300) installed on one container and thereafter allow the same spike interface cap (200) to be used with another spike assembly (300) installed on another container.

Description

Technical Field

[0001] The present invention relates generally to the injection of medical fluids and, more particularly, to the use of a bulk source of medical fluids for multi-patient injections. Background Art

[0002] 70% of CT scans require the injection of iodinated contrast media. In 70% of cases, this injection is performed using an automated contrast media injector. An injection tube is required to connect the automated injector to the patient.

[0003] For economic and ecological reasons (less use of plastic), multi-patient practices are steadily gaining market share. In 5 to 10 years, it is conceivable that multi-patient use will account for more than 75% of the world contrast medium injection market. In a so-called multi-patient practice, the tube of the syringe is provided in two distinct parts: a patient kit and a day kit. The patient kit is typically used to limit the risk of cross infection between successive patients and thus protect the day kit. Once installed and ready, the day kit remains connected to the power injector for use in multiple patient cases. This day kit comprises a filling line connected to the main container.

[0004] The connection to the main container can be made via a male Luer lock (Guerbet solution), or more generally, by connecting to a bottle via a spike. Over 95% of primary containers for contrast media or saline are bottles, typically made of glass or flexible plastic. The "common" part is the cover, which is typically equipped with a soft area, the septum. The septum is a piece of soft plastic material, typically around 70 or 80 ShA, that is characterized by a perforation shaped like a sharp point. The spike is connected to the primary container via the perforation in the septum, which then allows access to the liquid contained in the container.

[0005] In multi-patient use, this practice has led to tube usage for 12 or even 24 hours. In a 24-hour period, nearly 80 patients can be injected using the same tube. If the average contrast injection volume is 100 mL, and considering a maximum 500 mL contrast or saline container, between 16 and 32 primary containers can be used in a 24-hour period, depending on the volume of saline solution injected and the volume of the saline container.

[0006] The spike, typically a plastic needle, is most often attached to the drip chamber. Its primary function is to pierce the septum of the primary container, allowing access to the contrast agent and flow into the filling tube. To switch between empty and full bottles, the spike is removed from the first empty bottle and left in open air before being inserted into the new one. Because CT suites are not cleanrooms and the examination area is not sterile, the spike's considerable tip area could come into contact with an area of ​​accidental contamination or become contaminated by ambient air.

[0007] As the contaminant settles on the needle, when the next bottle is punctured, the contaminant could enter that bottle and contaminate the 500 mL of contrast medium. Thus, this contaminant would be able to spread from person to person, as successive injections are given, to the fill tube, then to the syringe, then to the injection tube, and finally to the patient.

[0008] In order to be able to perforate different types of septa (because of different types of bottles), the diameter of the spike needle is typically large (about 5mm to 6mm) and long (about 4cm to 6cm). The contact surface of the spike needle (exposed to the surrounding environment) is therefore very large, about 11.5cm 2 Combined with the sometimes long interconnection times between two bottles, poor sterilization of the bottle septum or mishandling (e.g. dropping it on the floor), the risk of contamination can be very high. Summary of the Invention

[0009] A medical container assembly is provided herein. The configuration of the individual components of the medical container assembly and the manner in which one or more of the individual components of the medical container assembly are connected are within the scope of the present invention. As used herein, the terms "proximal" and "distal" are used in relation to a patient using the medical container assembly for an injection, with "proximal" being closer to the patient than "distal."

[0010] The medical container can be of any suitable configuration and can include any suitable medical fluid (e.g., a contrast agent). The medical container can include at least one outlet closed by a septum, a seal, or the like. The medical container adapter assembly can include a spike assembly that passes through the septum and into the interior of the medical container, and a spike interface cap that can removably engage the spike assembly both before the spike assembly is mounted on the medical container and after the spike assembly has been mounted on the medical container, for example, to allow the spike interface cap to be removed from the spike assembly so that the same spike interface cap can be subsequently used with another medical container and another spike assembly. That is, the spike assembly can be configured as a disposable component (e.g., for use with a single medical container), while the spike interface cover can be configured as a multiple-use component (e.g., when the spike interface cover is removably engaged with the first spike assembly, it can be used with a first spike assembly on a first medical container; when the spike interface cover is removably engaged with the second spike assembly, it can be used with a second spike assembly (another spike assembly) mounted on a second medical container (another medical container)).

[0011] The spike assembly can include a container piercer that defines a distal end of the spike assembly (i.e., the end that engages the septum of the medical container). One or more air passages can extend from the exterior of the container piercer and through the interior of the spike assembly as it extends along the length dimension of the adapter assembly. Similarly, one or more liquid passages can extend from the exterior of the container piercer and through the interior of the spike assembly as it extends along the length dimension of the adapter assembly. In one or more embodiments, each air passage intersects the exterior of the container piercer at a location closer to the distal end of the container piercer (measured along the length dimension of the adapter assembly) than the location at which each liquid passage intersects the exterior of the container piercer. A plurality of elongated liquid inlet channels can be disposed on the exterior of the container piercer in a circumferentially spaced relationship and can include at least one liquid inlet port on the proximal end of each elongated liquid inlet channel (e.g., to direct liquid to one or more internal liquid passages of the spike assembly).

[0012] The container piercer may incorporate one or more features that address interaction of the container piercer with the septum of a medical container (e.g., related to installation of the spike assembly; related to at least hindering use of the spike assembly with two or more medical containers). The container piercer may include a frustoconical outer section extending from a distal tip of the container piercer (e.g., convex, defined by a small radius, or both). The outer transition section of the container piercer may extend proximally relative to the frustoconical outer section (including where the outer transition section extends substantially from the frustoconical outer section). The outer transition section of the container piercer may be concave as it extends along the length dimension of the container piercer, which may facilitate installation of the container piercer in the septum of a medical container. The air passageway may intersect the exterior of the container piercer at least within the outer transition section.

[0013] A plurality of elongated channels may be disposed on the exterior of the container piercer, may be disposed in a spaced relationship from one another, and may be recessed relative to the exterior of the container piercer. The width of each of the elongated channels may gradually decrease as it extends away from the distal end of the container piercer. The elongated channels may reduce the surface area of ​​the container piercer that interfaces with the septum of the medical container during the initial portion of installation of the spike assembly into the medical container, thereby reducing the amount of force required to install the spike assembly. The container piercer may be mounted on a distal end of a piercer extension that extends proximally from the container piercer, and when the spike assembly is in the installed configuration, the piercer extension may engage the septum of the medical container (e.g., to provide a suitable seal between the spike assembly and the septum of the medical container to reduce the likelihood of leakage of medical fluid from the medical container after the spike assembly is installed).

[0014] The proximal end of the container piercer may include a plurality of retaining members or protrusions, including three or more retaining members spaced around the periphery of the container piercer. Each retaining member may extend away from the central reference axis of the container piercer as it extends away from the distal end of the container piercer and reaches the free end of the corresponding retaining member. At least the lower section or proximal section of each retaining member may bend away from the central reference axis as it extends toward its corresponding free end. A space may be provided near and radially within the lower section or proximal section of each retaining member. This allows each retaining member to resiliently deflect radially inward (reducing the respective outer diameter of the container piercer) as the container piercer is guided through the septum of the medical container (e.g., reducing the required installation force), and further allows each such retaining member to move back toward its original position (e.g., back to an undeformed state; increasing the respective outer diameter of the container piercer) after fully entering the interior of the medical container (e.g., when the retaining member is no longer obstructed by ("clear") the inner surface of the septum) and should thereafter prevent the container piercer from being removed from the medical container (e.g., because "flared" retaining members may sometimes engage the inner surface of the septum).

[0015] At least the container piercer can be configured to separate from the remainder of the spike assembly when subjected to a first force. The spike assembly can be configured such that, when the spike assembly is in the installed configuration, the first force is insufficient to withdraw the container piercer from the septum of the medical container. When subjected to the first force, the container piercer should remain installed on the medical container, such that the spike assembly cannot be reused with another medical container, which may reduce the possibility of cross-contamination of patients.

[0016] The spike assembly can be characterized as comprising a base having an upper surface, and a perforator extending distally from the upper surface. The perforator can include the above-described container perforator (alone or in combination with the above-described perforator extension). The container perforator, the perforator extension, or both can each contain at least a portion of one or more liquid passages for the spike assembly and one or more air passages for the spike assembly. The upper surface of the base can be flat or planar, and the perforator can extend orthogonally in a distal dimension from the upper surface. One or more embodiments require that the outer diameter of the base be greater than the outer diameter of the perforator (e.g., the maximum outer diameter of the perforator).

[0017] The spike assembly may include an internal air chamber and a separate internal liquid chamber. Each liquid passageway of the punch may extend from the exterior of the punch to the liquid chamber. Similarly, each air passageway of the punch may extend from the exterior of the punch to the air chamber. The proximal end of the spike assembly may include a hub formed from a material having a reduced hardness compared to at least adjacent portions of the spike assembly. This allows a corresponding punch of the spike hub cap to extend through a corresponding portion of the hub to fluidically connect with a corresponding liquid chamber or air chamber of the spike assembly.

[0018] The spike interface cover can be removably connected to and removed from the spike assembly both before the spike assembly is installed on the medical container and after the spike assembly has been installed on the medical container (and all without damaging the spike interface cover so that the spike interface cover can be used with another spike assembly / medical container). The distal end of the spike interface cover can include a receptacle for receiving the proximal portion of the spike assembly. The receptacle can be defined by at least a plurality of upper wall segments that extend distally from a distal base surface of the spike interface cover (e.g., a flat or planar distal base surface).

[0019] A plurality of movable clips may extend distally beyond the distal base surface of the spike interface cover (and may further define at least a portion of the aforementioned receptacle). Each such clip may be movable between an open position (e.g., to allow the spike interface cover to be removed from the spike assembly, such as by a user engaging and guiding an actuating surface of each clip in an inward direction) and a closed or latched position, in which the head of each clip engages the spike assembly in a manner that removably connects the spike interface cover and the spike assembly (e.g., engagement of the clips of the spike interface cover with the spike assembly may limit or prevent movement of the spike interface cover along an axial path away from the spike assembly to separate these components). The movement of the clips may be pivotal or pivot-like (e.g., via movement of a living hinge between a given clip and a corresponding portion of the spike interface cover). Each clip may be biased (e.g., resiliently) toward its closed or latched position. The spike assembly, the spike interface cover, or both may include features that require the spike interface cover to be installed on the spike assembly in only a single orientation, such as by having the head of one clip of the spike interface cover wider than the head of another clip of the spike interface cover, and by having the spike assembly include a channel of corresponding width on the outer periphery of the spike assembly.

[0020] The spike interface cover can include a perforator that extends into the air chamber of the spike assembly (e.g., by piercing / extending through a corresponding portion of the interface on the proximal end of the spike assembly) and another perforator that extends into the liquid chamber of the spike assembly (e.g., by piercing / extending through a corresponding portion of the interface on the proximal end of the spike assembly). These perforators can extend distally from the distal base surface of the spike interface cover. The distal ends of these perforators can be substantially offset from (e.g., recessed from) the distal end of the upper wall segment and / or the head of the clip, which can reduce the possibility of contamination of the spike interface cover perforators before the spike interface cover is installed on the spike assembly.

[0021] One or more air passages can extend through corresponding perforators of the spike interface cover (perforators extending into the air chamber of the spike assembly). External air directed into the one or more air passages of the spike interface cover can pass through one or more filters before entering the air chamber of the spike assembly. One or more liquid passages can extend through corresponding perforators of the spike interface cover (perforators extending into the liquid chamber of the spike assembly). Each liquid passage of the spike interface cover can extend to a container that can be interconnected with / extend from the proximal end of the spike interface cover (e.g., a drip chamber). The container can include a medical catheter interface configured to connect any suitable type of medical catheter to the container.

[0022] Any feature of any of the various aspects of the present invention that is intended to be limited to the "singular" case will be clearly set forth herein by terms such as "only," "single," "limited to," etc. The mere introduction of a feature in this disclosure based on generally accepted prior art practice does not limit the corresponding feature to the singular (e.g., merely stating that a container piercer includes a "liquid passageway" does not mean that the container piercer includes only a single liquid passageway). Furthermore, the absence of phrases such as "at least one" and the like herein does not limit the corresponding feature to the singular (e.g., merely stating that a container piercer includes a "liquid passageway" does not mean that the container piercer includes only a single liquid passageway). The use of phrases such as "at least substantially" and the like in connection with particular features encompasses both the corresponding feature and insubstantial variations thereof (e.g., stating that a base surface is at least substantially flat encompasses that the base surface is substantially flat). Finally, a feature recited in conjunction with the phrase "in one embodiment" does not limit the use of that feature to a single embodiment.

[0023] Various aspects of the invention are also set forth in the following paragraphs and combinations thereof:

[0024] 1. A medical fluid container adapter assembly, comprising:

[0025] a first connector portion comprising a container piercer, a first liquid passageway, and a first air passageway, wherein the container piercer comprises a distal tip and an exterior, and wherein the first connector portion is connectable to a medical fluid container and is a disposable connector portion, wherein the first connector is a disposable connector portion; and

[0026] A multi-use assembly is detachably connected to the first connector portion, wherein the multi-use assembly includes a medical catheter interface and a second connector portion, the second connector portion including a second liquid passage and a second air passage, and wherein the first liquid passage and the first air passage of the first connector portion are fluidly connected to the second liquid passage and the second air passage of the second connector portion, respectively.

[0027] 2. The medical fluid container adapter assembly of paragraph 1, wherein the first connector portion comprises a spike assembly.

[0028] 3. The medical fluid container adapter assembly of any of paragraphs 1 to 2, wherein the first connector portion further includes a first body, which further includes a first base distal surface, the container piercer protrudes distally relative to the first base distal surface, and the container piercer includes the first liquid passage and the first air passage.

[0029] 4. The medical fluid container adapter assembly of paragraph 3, wherein a separation force is less than a removal force, wherein the separation force is a minimum force required to separate the container piercer from the first body, and wherein the removal force is a minimum force required to remove the container piercer from the medical fluid container when the medical container adapter assembly is in the installed configuration.

[0030] 5. The medical fluid container adapter assembly of paragraph 3, wherein the first connector portion is configured such that the container piercer will separate from the first body when subjected to a first force, the first force being insufficient to remove the container piercer from the medical fluid container when the medical fluid container adapter assembly is in the installed configuration and with the container piercer remaining connected to the first body.

[0031] 6. The medical fluid container adapter assembly of any of paragraphs 3 to 5, wherein the first body further includes a base and a perforator extension, the base including the first base distal surface, the perforator extension extending distally from the first base distal surface and including the first liquid passage and the first air passage, and the container perforator is interconnected with the perforator extension.

[0032] 7. The medical fluid container adapter assembly of any of paragraphs 3 to 6, wherein the first body includes a liquid chamber fluidly connected to the first liquid passage and an air chamber fluidly connected to the first air passage, wherein the second liquid passage of the second connector portion is fluidly connected to the liquid chamber and the second air passage of the second connector portion is fluidly connected to the air chamber.

[0033] 8. The medical fluid container adapter assembly of any of paragraphs 1 to 7, wherein the second air passageway of the second connector portion includes a filter.

[0034] 9. The medical fluid container adapter assembly of any of paragraphs 1 to 8, wherein the second air passageway of the second connector portion terminates on an exterior of the second connector portion.

[0035] 10. The medical fluid container adapter assembly of any of paragraphs 1 to 9, wherein the second connector portion includes a distal end comprising a receptacle, wherein the first body of the first connector portion extends proximally within the receptacle.

[0036] 11. The medical fluid container adapter assembly of any of paragraphs 3 to 6, 8, and 9, wherein the first body includes a proximal end spaced apart from the first base distal surface of the first body, the first connector portion includes a first interface disposed on the proximal end of the first body for connecting to the second connector portion, and the first interface has a first hardness and the first body has a second hardness greater than the first hardness.

[0037] 12. The medical fluid container adapter assembly of paragraph 11, wherein the first interface of the first connector portion includes a first perforable section in the flow path to the first liquid passage and a second perforable section in the flow path to the first air passage.

[0038] 13. A medical fluid container adapter assembly as described in paragraph 12, wherein the second connector portion includes a second base distal surface, a perforator for the second liquid pathway, and a perforator for the second air pathway, wherein the perforator for the second liquid pathway protrudes distally from the second base distal surface, is fluidly connected to the second liquid pathway, and extends through the first perforable section of the first interface for the first connector portion, and wherein the perforator for the second air pathway protrudes from the second base distal surface, is fluidly connected to the second air pathway, and extends through the second perforable section of the first interface for the first connector portion.

[0039] 14. A medical fluid container adapter assembly as described in paragraph 13, wherein the first interface is configured to deform when the perforator for the second liquid pathway of the second connector portion is guided into and through the first perforable section of the first interface for the first connector portion, and is further configured to deform when the perforator for the second air pathway of the second connector portion is guided into and through the second perforable section of the first interface for the first connector portion.

[0040] 15. The medical fluid container adapter assembly of any of paragraphs 13 to 14, wherein the first interface of the first connector portion seals each of the perforator for the second liquid passage of the second connector portion and the perforator for the second air passage of the second connector portion.

[0041] 16. The medical fluid container adapter assembly of any of paragraphs 13 to 15, wherein the first pierceable section and the second pierceable section each include a plurality of segments configured to separate from one another along a predetermined path.

[0042] 17. The medical fluid container adapter assembly of any of paragraphs 13 to 16, wherein the piercer for the second liquid pathway comprises the second liquid pathway and the piercer for the second air pathway comprises the second air pathway.

[0043] 18. A medical fluid container adapter assembly as described in any of paragraphs 13 to 17, wherein the first body includes a liquid chamber connected to the first liquid passage fluid and an air chamber connected to the first air passage fluid, wherein the second liquid passage of the second connector part is connected to the liquid chamber fluid and the second air passage of the second connector part is connected to the air chamber fluid, wherein the perforator for the second liquid passage extends into the liquid chamber, and wherein the perforator for the second air passage extends into the air chamber.

[0044] 19. The medical fluid container adapter assembly of any of paragraphs 13 to 18, wherein the second portion further comprises a plurality of upper wall segments spaced apart from one another and projecting distally from the second base distal surface of the second connector portion, wherein the perforator for the second liquid passage and the perforator for the second air passage are located within an outer periphery jointly defined by the plurality of upper wall segments.

[0045] 20. The medical fluid container adapter assembly of paragraph 19, wherein the distal end of each of the perforators for the second liquid passage and the perforators for the second air passage is disposed closer to the second base distal surface than the distal end of each of the plurality of upper wall segments.

[0046] 21. The medical fluid container adapter assembly of any of paragraphs 19 to 20, wherein a first upper wall segment and a second upper wall segment of the plurality of upper wall segments are movable between an open position and a closed position to removably connect the second connector portion to the first connector portion.

[0047] 22. The medical fluid container adapter assembly of any of paragraphs 19 to 21, wherein the plurality of upper wall segments of the second connector portion are disposed exteriorly of the first connector portion.

[0048] 23. The medical fluid container adapter assembly of any of paragraphs 19 to 22, wherein the outer diameter of the proximal portion of the first body is greater than the outer diameter of the container piercer, and wherein the outer periphery of the proximal portion of the first body is disposed in at least one of the following situations: disposed in close spacing relationship with the plurality of upper wall segments of the second connector portion or disposed in contact with the plurality of upper wall segments.

[0049] 24. The medical fluid container adapter assembly of paragraph 11, wherein the first interface comprises a first region and a second region, and each of the first and second regions comprises a plurality of sealing segments separated from each other by thin-walled sections.

[0050] 25. A medical fluid container adapter assembly as described in paragraph 24, wherein the second connector portion includes a second base distal surface, a perforator for the second liquid pathway, and a perforator for the second air pathway, wherein the perforator for the second liquid pathway protrudes distally from the second base distal surface, is fluidly connected to the second liquid pathway, and extends through the first region of the first interface for the first connector portion by separating each pair of adjacent sealing segments in the first region and with the sealing segments in the first region sealing the outer periphery of the perforator for the second liquid pathway, wherein the perforator for the second air pathway protrudes distally from the second base distal surface, is fluidly connected to the second air pathway, and extends through the second region of the first interface for the first connector portion by separating each pair of adjacent sealing segments in the second region and with the sealing segments in the second region sealing the outer periphery of the perforator for the second liquid pathway.

[0051] 26. The medical fluid container adapter assembly of any of paragraphs 3 to 25, wherein the container piercer extends along a first reference axis as it extends distally away from the first base distal surface of the first connector portion.

[0052] 27. A medical fluid container adapter assembly as described in paragraph 26, wherein the container perforator includes at least three retaining segments that are spaced apart from each other, extend away from the first reference axis as they extend in a direction toward the first base distal surface of the first connector portion, and have free ends spaced apart from the first base distal surface of the first connector portion, wherein an open space is located adjacent to and radially inward of each of the retaining segments.

[0053] 28. The medical fluid container adapter assembly of paragraph 27, wherein the proximal section of each retaining member curves away from the first reference axis as it extends to the corresponding free end.

[0054] 29. The medical fluid container adapter assembly of any of paragraphs 26 to 28, wherein the distal tip of the container piercer is at least one of convex and defined by a radius.

[0055] 30. The medical fluid container adapter assembly of paragraph 29, wherein the radius of the distal tip is at least one of less than 0.15 mm or less than 0.05 mm.

[0056] 31. The medical fluid container adapter assembly of any of paragraphs 26 to 28, wherein the container piercer comprises a frustoconical section and a transition section, the frustoconical section being disposed between the distal tip and the transition section, and the transition section being located between the frustoconical section and the multi-use assembly.

[0057] 32. The medical fluid container adapter assembly of paragraph 31, wherein the distal tip of the container piercer is at least one of convex and defined by a radius.

[0058] 33. The medical fluid container adapter assembly of paragraph 32, wherein the radius of the distal tip is at least one of less than 0.15 mm or less than 0.05 mm.

[0059] 34. The medical fluid container adapter assembly of any of paragraphs 31 to 33, wherein the transition section is a concave surface on the exterior of the container piercer that extends from the frustoconical section toward the multi-use assembly.

[0060] 35. The medical fluid container adapter assembly of any of paragraphs 31 to 34, wherein the container piercer further comprises a recessed air inlet port on the outer surface of the container piercer and fluidly connected to the first air passageway.

[0061] 36. The medical fluid container adapter assembly of paragraph 35, wherein the frustoconical section and the transition section each comprise the air inlet port.

[0062] 37. The medical fluid container adapter assembly of any of paragraphs 35 to 36, wherein the container piercer further comprises a plurality of elongated liquid inlet channels spaced apart from one another and concave on the exterior of the container piercer, and wherein each of the elongated liquid inlet channels is fluidly connected to at least one of the first liquid passages.

[0063] 38. A medical fluid container adapter assembly as described in paragraph 37, wherein the closest spacing between the distal tip of the container piercer and the intersection of the first air passage and the exterior of the container piercer is less than the closest spacing between the distal tip and each of the elongated liquid inlet channels.

[0064] 39. The medical fluid container adapter assembly of any of paragraphs 37 to 38, further comprising a plurality of elongated channels spaced apart from one another on the exterior of the container piercer, disposed between each pair of adjacent elongated liquid inlet channels, and recessed.

[0065] 40. The medical fluid container adapter assembly of paragraph 39, wherein the width of each of the plurality of elongated channels gradually decreases as it extends proximally away from the end closest to the distal tip of the container piercer.

[0066] 41. The medical fluid container adapter assembly of any of paragraphs 1 to 35, wherein the container piercer further comprises a plurality of elongated liquid inlet channels spaced apart from one another and recessed on the exterior of the container piercer, wherein each of the elongated liquid inlet channels is fluidly connected to at least one of the first liquid passages.

[0067] 42. The medical fluid container adapter assembly of paragraph 41, further comprising a plurality of elongated channels spaced apart from one another on the exterior of the container piercer, disposed between each pair of adjacent elongated liquid inlet channels, and recessed.

[0068] 43. The medical fluid container adapter assembly of paragraph 42, wherein the width of each of the plurality of elongated channels gradually decreases as it extends proximally from an end closest to the distal tip of the container piercer.

[0069] 44. The medical fluid container adapter assembly of any of paragraphs 1 to 37, further comprising a plurality of elongated channels spaced apart from one another and recessed on the exterior of the container piercer.

[0070] 45. The medical fluid container adapter assembly of paragraph 44, wherein the width of each of the plurality of elongated channels gradually decreases as it extends proximally away from the end closest to the distal tip of the container piercer.

[0071] 46. ​​The medical fluid container adapter assembly of any of paragraphs 3 to 45, wherein the first body comprises a first catch and a second catch spaced apart from each other, wherein the second connector portion comprises a second body and a first clip and a second clip, the first clip and the second clip being movable relative to the second body and removably engaging the first catch and the second catch, respectively, to removably connect the first connector portion and the second connector portion.

[0072] 47. The medical fluid container adapter assembly of paragraph 46, wherein the first and second snaps are disposed on an outer periphery of the first body of the first connector portion.

[0073] 48. The medical fluid container adapter assembly of paragraph 47, wherein the first body comprises a first channel and a second channel disposed on the outer periphery of the first body of the first connector portion, wherein the first clip and the second clip of the second connector portion are disposed in the first channel and the second channel, respectively.

[0074] 49. The medical fluid container adapter assembly of paragraph 48, wherein the first channel and the second channel of the first connector portion have different widths.

[0075] 50. The medical fluid container adapter assembly of paragraph 49, wherein the first clip of the second connector portion is positionable in the first channel of the first connector portion but not in the second channel of the first connector portion.

[0076] 51. The medical fluid container adapter assembly of paragraph 50, wherein the first clamp of the first connector portion is wider than the second channel of the first connector portion.

[0077] 52. The medical fluid container adapter assembly of any of paragraphs 48 to 51, wherein the first channel and the second channel of the first connector portion are configured to accommodate only a single relative orientation between the first connector portion and the second connector portion when removably connected.

[0078] 53. The medical fluid container adapter assembly of any of paragraphs 46 to 52, wherein the first snap comprises a first angled surface and a first end surface, and wherein the second snap comprises a second angled surface and a second end surface.

[0079] 54. The medical fluid container adapter assembly of paragraph 53, wherein the first inclined surface flares outwardly as it extends in a direction toward the first end surface and the second inclined surface flares outwardly as it extends in a direction toward the second end surface.

[0080] 55. The medical fluid container adapter assembly of any of paragraphs 53 to 54, wherein the first clamp and the second clamp of the second connector portion respectively engage the first end surface and the second end surface of the first connector portion.

[0081] 56. The medical fluid container adapter assembly of any of paragraphs 53 to 55, wherein the first end surface and the second end surface are oriented at least approximately orthogonal to a length dimension of the first connector portion, and the container piercer protrudes in the length dimension.

[0082] 57. The medical fluid container adapter assembly of any of paragraphs 46 to 56, wherein the first clamp and the second clamp of the second connector portion are pivotable relative to the second body of the second connector portion.

[0083] 58. The medical fluid container adapter assembly of any of paragraphs 46 to 57, wherein the second connector portion further comprises a first living hinge between the first clamp and the second body, and a second living hinge between the second clamp and the second body.

[0084] 59. The medical fluid container adapter assembly of any of paragraphs 46 to 58, wherein the second connector portion further comprises a first stop protruding from the second body and aligned with the first clip, and a second stop protruding from the second body and aligned with the second clip.

[0085] 60. The medical fluid container adapter assembly of paragraph 59, wherein the first stop limits the amount of relative movement between the first clamp and the second body and the second stop limits the amount of relative movement between the second clamp and the second body.

[0086] 61. The medical fluid container adapter assembly of any of paragraphs 46 to 60, further comprising a sterile cover disposed on each of the container piercers, a first latch connection between the first clip of the second connector portion and the first snap of the first connector portion, and a second latch connection between the second clip of the second connector portion and the second snap of the first connector portion.

[0087] 62. The medical fluid container adapter assembly of paragraph 61, wherein the sterile cap includes at least one detent that engages the container piercer.

[0088] 63. The medical fluid container adapter assembly of any of paragraphs 61 to 62, wherein the sterile cap includes first and second receivers for the first clip and the second clip of the second connector portion, respectively, when engaged with the first catch and the second catch of the first connector portion, respectively.

[0089] 64. The medical fluid container adapter assembly of paragraph 63, wherein the first receiver and the second receiver are disposed in opposing relationship to each other.

[0090] 65. The medical fluid container adapter assembly of any of paragraphs 63 to 64, wherein the first and second receptacles each protrude from adjacent side walls of the sterile cap.

[0091] 66. The medical fluid container adapter assembly of any of paragraphs 63 to 65, wherein the first receiver and the second receiver each define an internal space that provides space for movement of the first clamp and the second clamp relative to the second body of the second connector part when the second connector part moves relative to the first connector part to removably connect the first connector part and the second connector part.

[0092] 67. The medical fluid container adapter assembly of any of paragraphs 61 to 66, wherein the sterile cap is removable from the first connector portion when the first connector portion is removably connected to the second connector portion.

[0093] 68. The medical fluid container adapter assembly of any of paragraphs 61 to 67, wherein the sterile cap is a blister pack.

[0094] 69. A medical fluid container adapter assembly as described in any of paragraphs 3 to 12 and 26 to 68, wherein the second connector portion includes a second base distal surface, a perforator for the second liquid passage, and a perforator for the second air passage, the perforator for the second liquid passage protruding distally from the second base distal surface and connected to the second liquid passage fluid, and the perforator for the second air passage protruding distally from the second base distal surface and connected to the second air passage fluid.

[0095] 70. A medical fluid container adapter assembly as described in paragraph 69, wherein the second portion further includes a plurality of upper wall segments that are spaced apart from each other and protrude distally from the second base distal surface of the second connector portion, wherein the perforator for the second liquid passage and the perforator for the second air passage are located within an outer periphery jointly defined by the plurality of upper wall segments.

[0096] 71. A medical fluid container adapter assembly as described in paragraph 70, wherein the distal end of each of the perforators for the second liquid passage and the perforators for the second air passage is positioned closer to the distal surface of the second base than the distal end of each of the plurality of upper wall segments.

[0097] 72. The medical fluid container adapter assembly of any of paragraphs 70 to 71, wherein a first upper wall segment and a second upper wall segment of the plurality of upper wall segments are movable between an open position and a closed position to removably connect the second connector portion to the first connector portion.

[0098] 73. The medical fluid container adapter assembly of any of paragraphs 70 to 72, wherein the plurality of upper wall segments of the second connector portion are disposed exteriorly of the first connector portion.

[0099] 74. The medical fluid container adapter assembly of any of paragraphs 70 to 73, wherein the outer diameter of the proximal portion of the first body is greater than the outer diameter of the container piercer, and wherein the outer periphery of the proximal portion of the first body is arranged in at least one of the following situations: arranged in a closely spaced relationship with the multiple upper wall segments or arranged in contact with the multiple upper wall segments.

[0100] 75. The medical fluid container adapter assembly of any of paragraphs 1 to 74, wherein the multi-use assembly further comprises a drip chamber extending from the second connector portion, wherein the second connector portion is disposed between the first connector portion and the drip chamber.

[0101] 76. The medical fluid container adapter assembly of paragraph 75, wherein the medical conduit hub extends from the drip chamber, and wherein the drip chamber is disposed between the second connector portion and the medical conduit hub.

[0102] 77. The medical fluid container adapter assembly of any of paragraphs 1 to 76, wherein the multi-use assembly further comprises a medical conduit extending from the medical conduit hub.

[0103] 78. A medical container assembly comprising a medical fluid container and the medical fluid container adapter assembly of any of paragraphs 1 to 77, wherein the medical fluid container includes a container seal and wherein the container piercer of the first connector portion extends through the container seal.

[0104] 79. A spike assembly for fluidly accessing a medical fluid container, the spike assembly comprising an elongated spike, the elongated spike further comprising:

[0105] a central reference axis, the central reference axis being coincident with the length dimension of the elongated spike;

[0106] a distal end and a proximal end, the distal end and the proximal end being spaced apart from one another along a length dimension of the elongated spike;

[0107] a first liquid passageway intersecting the exterior of the spike and extending along the length dimension within the interior of the elongated spike;

[0108] a first air passageway intersecting the exterior of the elongated spike and running along the length dimension within the interior of the elongated spike;

[0109] Wherein, the outer portion of the elongated spike includes a truncated conical section and a transition section, the truncated conical section is arranged between the distal end and the transition section, the transition section is located between the truncated conical section and the proximal end, and the transition section is a concave surface on the outer portion of the spike extending from the truncated conical section in the direction toward the proximal end.

[0110] 80. The spike assembly of paragraph 79, wherein the distal end of the elongated spike is at least one of convex and defined by a radius.

[0111] 81. The spike assembly of paragraph 80, wherein the radius of the distal end is at least one of less than 0.15 mm or less than 0.05 mm.

[0112] 82. The spike assembly of any of paragraphs 79 to 81, wherein the first air passage intersects the transition section on the exterior.

[0113] 83. The spike assembly of any of paragraphs 79 to 81, wherein the first air passage intersects each of the frustoconical section and the transition section on the exterior.

[0114] 84. The spike assembly of any of paragraphs 79 to 83, wherein the distal section of the spike assembly comprises a vessel piercer, wherein the distal tip of the vessel piercer comprises the distal end of the elongated spike.

[0115] 85. A spike assembly as described in paragraph 84, wherein the container piercer further includes a plurality of elongated liquid inlet channels that are spaced apart from each other and recessed on the exterior of the container piercer, and wherein each of the elongated liquid inlet channels is fluidly connected to at least one of the first liquid passages.

[0116] 86. A spike assembly as described in paragraph 85, wherein the closest distance between the distal end of the container piercer and the intersection of the first air passage and the exterior of the container piercer is less than the closest distance between the distal end of the container piercer and each of the elongated liquid inlet channels.

[0117] 87. The spike assembly of any of paragraphs 85 to 86, further comprising a plurality of elongated channels spaced apart from one another on the exterior of the container piercer, disposed between each pair of adjacent elongated liquid containing channels, and recessed.

[0118] 88. The spike assembly of paragraph 87, wherein the width of each of the plurality of elongated channels gradually decreases as the width extends proximally away from the end closest to the distal tip of the vessel piercer.

[0119] 89. The spike assembly of any of paragraphs 79 to 84, further comprising a plurality of elongated channels spaced apart from one another and recessed on the exterior of the container piercer.

[0120] 90. The spike assembly of paragraph 89, wherein the width of each of the plurality of elongated channels gradually decreases as it extends away from an end closest to the distal tip of the vessel piercer.

[0121] 91. A spike assembly as described in any of paragraphs 79 to 83, wherein the elongated spike includes a perforator extension and a container perforator mounted on the distal end of the perforator extension, wherein the perforator extension extends from the container perforator to the proximal end, and wherein the perforator extension and the container perforator each include the first liquid passage and the first air passage.

[0122] 92. A spike assembly as described in paragraph 91, wherein the container perforator includes at least three retaining segments that are spaced apart from each other, extend away from the central reference axis as they extend in a direction toward the proximal end, and have free ends spaced radially outward from the perforator extension.

[0123] 93. The spike assembly of paragraph 92, wherein the proximal section of each retaining member curves away from the central reference axis as it extends to the corresponding lower free end.

[0124] 94. The spike assembly of any of paragraphs 92 to 93, wherein the spike assembly further comprises a base, the base further comprising a base distal surface, wherein the perforator extension extends from the base distal surface.

[0125] 95. The spike assembly of paragraph 94, wherein the base has an outer diameter that is greater than an outer diameter of each of the piercer extension and the container piercer.

[0126] 96. The spike assembly of any of paragraphs 94 to 95, wherein the free end of each retaining member is disposed in spaced relation to the base distal surface.

[0127] 97. The spike assembly of any of paragraphs 91 to 96, wherein the separation force is less than the removal force, the separation force being the minimum force required to separate the container piercer from the piercer extension, the removal force being the minimum force required to remove the container piercer from the medical fluid container when the spike assembly is in the installed configuration, and the separation force is less than the removal force.

[0128] 98. A spike assembly for fluidly accessing a medical fluid container, the spike assembly comprising an elongated spike, the elongated spike further comprising:

[0129] a central reference axis, the central reference axis being coincident with the length dimension of the elongated spike;

[0130] a distal end and a proximal end, the distal end and the proximal end being spaced apart from one another along a length dimension of the elongated spike;

[0131] perforator extensions;

[0132] a vessel piercer mounted on the distal end of the piercer extension, wherein the piercer extension extends proximally from the vessel piercer to the proximal end;

[0133] a first liquid passageway intersecting the exterior of the spike and extending along the length dimension within the interior of the elongated spike;

[0134] a first air passageway intersecting the exterior of the elongated spike and running along the length dimension within the interior of the elongated spike;

[0135] wherein the piercer extension and the container piercer each include the first liquid passage and the first air passage; and

[0136] The container piercer includes at least three retaining segments that are spaced apart from each other, extend away from the central reference axis as they proceed in a direction toward the proximal end, and have free ends spaced radially outward from the piercer extension.

[0137] 99. The spike assembly of paragraph 98, wherein the proximal section of each retaining member curves away from the central reference axis as it extends to the corresponding free end.

[0138] 100. The spike assembly of any of paragraphs 98 to 99, wherein the spike assembly further comprises a base, the base further comprising a base distal surface, wherein the perforator extension extends distally from the base distal surface.

[0139] 101. The spike assembly of paragraph 100, wherein the base has an outer diameter that is greater than an outer diameter of each of the piercer extension and the container piercer.

[0140] 102. The spike assembly of any of paragraphs 100 to 101, wherein the free end of each retaining member is disposed in spaced relationship from the base distal surface. BRIEF DESCRIPTION OF THE DRAWINGS

[0141] Figure 1 is a perspective view of a medical container assembly that uses a medical container adapter assembly to provide a fluid connection between a medical fluid container and medical tubing.

[0142] Figure 2 yes Figure 1 A perspective view of a medical container adapter assembly utilizing a removably connectable disposable spike assembly and a multi-use spike interface cap.

[0143] Figure 3 yes Figure 2 Side view of the spike interface cover.

[0144] Figure 4 yes Figure 2 A top view of the spike interface cover.

[0145] Figure 5 yes Figure 2 An enlarged perspective view of the spike interface cover.

[0146] Figure 6 It is installed on the medical fluid container Figure 2 A cross-sectional view of a medical container adapter assembly.

[0147] Figure 7 yes Figure 2 A perspective view of a medical container adapter assembly with a piercer cap / blister pack assembly mounted on a spike assembly.

[0148] Figure 8 yes Figure 7 A perspective view of a perforator cover / blister pack.

[0149] Figure 9 yes Figure 2 A cross-sectional view of a spike assembly.

[0150] Figure 10 yes Figure 2 A perspective view of the lower or proximal end of the spike assembly.

[0151] Figure 11 yes Figure 2 A perspective view of one side of a variation of a spike assembly.

[0152] Figure 12 yes Figure 11 A perspective view of a spike assembly used with a vessel perforator.

[0153] Figure 13A yes Figure 2 A perspective view of a spike assembly used with a vessel perforator.

[0154] Figure 13B yes Figure 13A An enlarged stereoscopic view of the distal end of a vessel perforator.

[0155] Figure 13C yes Figure 13A A perspective view of the proximal end of a variation of a vessel perforator.

[0156] Figure 13D yes Figure 13C A perspective view of a vessel perforator.

[0157] Figure 13E yes Figure 13A Cross-sectional view of a vessel perforator.

[0158] Figure 14 yes Figure 2 Side view of the spike assembly.

[0159] Figure 15A yes Figure 2 Cross-sectional view of the spike assembly.

[0160] Figure 15B yes Figure 2 Another cross-sectional view of the spike assembly.

[0161] Figure 15C It is along Figure 15B A cross-sectional view taken along line AA.

[0162] Figure 16 yes Figure 2 The base of the spike assembly along Figure 6 A cross-sectional view taken along line BB in FIG.

[0163] Figure 17 yes Figure 2A perspective view of the inside of the end cap of the spike assembly.

[0164] Figure 18 yes Figure 17 A three-dimensional view of the outside of the end cap.

[0165] Figure 19A yes Figure 17 A perspective view of the outside of a variation of an end cap using multiple segments separated along a predetermined path.

[0166] Figure 19B yes Figure 19A A perspective view of an interface or insert used with a cover.

[0167] Figure 19C yes Figure 19B A top view of the interface.

[0168] Figure 19D yes Figure 19C A cross-sectional view of the interface taken along line DD.

[0169] Figure 20 yes Figure 1 A perspective view of a medical container assembly with the spike interface cover removed from the spike assembly.

[0170] Figure 21 yes Figure 20 A cross-sectional view of a medical container assembly. DETAILED DESCRIPTION

[0171] Medical container components Figure 1 , and is identified by reference numeral 20. The medical container assembly 20 includes a medical fluid container 400 and a medical fluid container adapter kit or assembly 40 (hereinafter also referred to as "medical container adapter assembly 40"). The medical fluid container 400 can hold any suitable medical fluid (such as contrast agent) and is sized to accommodate use with multiple injections (e.g., multiple injections for one patient, but more typically for multiple patients). That is, the medical fluid container 400 has sufficient storage volume so that the medical fluid container 400 does not need to be replaced between injections. The medical fluid container 400 can have any suitable construction, can be formed from any suitable material or combination of materials, and can have any suitable volume. Examples of medical containers 400 include bottles (e.g., glass; rigid), bags (e.g., flexible), and the like.

[0172] Figure 1 and Figure 2An example of a medical container adapter assembly 40 is shown in FIG. The medical fluid container adapter assembly 40 includes a first connector portion and a second connector portion. In the following description, the first connector portion is a spike assembly and the second connector portion is a spike interface cap. Thus, the medical fluid container adapter assembly 40 includes a spike assembly 300 (e.g., the first connector portion), a spike interface cap 200 (e.g., the second connector portion) for the spike assembly 300, and a container (e.g., a drip chamber) 100. The spike assembly 300 is configured to be fluidically connected to the medical container 400, and the spike interface cap 200 is configured to be removably connected to the spike assembly 300. The multi-use assembly 50 may include the spike interface cap 200 and the container 100. A medical tube or conduit 60 (e.g., flexible / pliable) is interconnected with the container 100 and extends therefrom (e.g., to an injection device (e.g., a power injector), such as a syringe used by the injection device). Typically, spike assembly 300 is a disposable connector component configured for a single use (i.e., for use with a single medical container 400). In other words, spike assembly 300 is configured to reduce the likelihood that spike assembly 300 can be installed on one medical fluid container 400, used for multiple injections (for one or more patients), removed from container 400 (e.g., in an empty or reduced-volume condition), installed on a different medical fluid container 400 (e.g., in a "full" condition), and then used for multiple injections (for one or more patients). The configuration of spike assembly 300 should reduce the likelihood of contamination.

[0173] Continue to refer Figure 1 and Figure 2 , the container 100 of the adapter assembly 40 has two distinct regions: a tube coupling region (or medical tube / tube interface) 120 for assembly onto the medical tube 60 (e.g., to accommodate connection of the medical tube 60 to the container 100); and a chamber portion 110 for receiving the medical fluid prior to injection (e.g., for priming the medical tube 60 and visualizing the flow of the fluid). The spike interface cap 200 can be secured to the upper portion of the chamber 110 in any suitable manner, such as by bonding (e.g., with a solvent or any suitable adhesive), heat sealing, RF sealing, etc. The medical tube interface 120 can be incorporated in any suitable manner to receive the flow of fluid from the spike interface cap 200.

[0174] As will be discussed in more detail below, spike assembly 300 includes (e.g., with Figure 9 and Figure 10327 and air passage 328. Spike assembly 300 also includes a port 335 located at proximal end 324 of spike assembly and having port 332 (air flow) and port 333 (liquid), each of which is fluidically connectable to container piercer 340 of spike assembly 300, which is disposed within / extends within the interior of medical fluid container 400. Port 335 is how / where spike port cap 200 is fluidically connected to spike assembly 300.

[0175] Spike interface cover 200 is shown in Figures 1 to 5 The spike port cap 200 is an interface that can be used for an extended period of time of any suitable duration (e.g., 12 hours or 24 hours) to connect the spike port cap 200 to a single bottle spike assembly 300 mounted on a medical fluid container 400. However, the spike port cap 200 can be removed from one spike assembly 300 (mounted on one medical fluid container 400) and can be mounted on another spike assembly 300 (mounted on a completely separate medical fluid container 400). Likewise, each medical fluid container 400 can be used for multiple injections (e.g., for multiple patients). This can be repeated any suitable number of times (e.g., the spike port cap 200 can be used with any suitable number of medical fluid containers 400, each with a dedicated spike assembly 300). Thus, the spike port cap 200 can be referred to as reusable, multiple-use, etc.

[0176] The spike interface cover 200 can be characterized as including a body 210 having any suitable configuration (e.g., a unitarily formed structure; formed from one or more shells / segments suitably connected to one another). The spike interface cover 200 can be removably connected to the spike assembly 300. That is, the spike interface cover 200 can be characterized as being changeable or movable throughout a range from a connected, latched, or closed configuration (in which the spike interface cover 200 is mounted to the spike assembly 300 and which can restrict relative movement between the spike interface cover 200 and the spike assembly 300 in at least one dimension, such as along the length of the spike assembly 300) to an open or unlocked configuration (to accommodate removal of the spike interface cover 200 from the spike assembly 300, such as by relative movement of these components away from each other along an axial path), all without compromising the structural integrity of the spike interface cover 200. In this regard, the spike interface cover 200 includes a plurality of clips or clamps that are movably integrated with the body 210 of the spike interface cover 200 and removably engage the spike assembly 300 (in a connected or latched configuration). The spike interface cover 200 may utilize any suitable number of such clips. In the illustrated embodiment, the spike interface cover 200 utilizes a pair of clips 221, 223, with the clips 221, 223 being disposed in an opposing relationship to one another (e.g., disposed or spaced 180° apart about a central reference axis of the adapter assembly 40 that coincides with the length dimension of the adapter assembly 40).

[0177] Each of the clips 221, 223 includes a finger placement area or actuation surface / section 220 and a head 224 that are spaced apart from each other. The heads 224 of the clips 221, 223 can have different widths to provide a positional registration feature relative to the spike assembly 300 (e.g., so that the spike interface cover 200 can only be installed on the spike assembly 300 in one orientation), and will be discussed in more detail below. A hinge 222 of any suitable type interconnects the clips 221, 223 with the body 210 of the spike interface cover 200 and is disposed between the actuation surface 220 and the corresponding head 224 of each clip 221, 223. The hinge 222 can be in the form of a living hinge, for example, the clips 221, 223 can be integrally formed with the body 210 of the spike interface cover 200, and wherein the hinge 222 is an elastically deformable section that allows each clip 221, 223 to move (e.g., pivot) about its corresponding hinge 222. Each clip 221, 223 can be biased to a position in which the clip 221, 223 will removably engage the spike assembly 300. The range of motion can be characterized as from a neutral position (e.g., the clips 221, 223 are in a non-elastically deformed state) to an open position in which the head 324 of the clip 221, 223 is disengaged from the spike assembly 300 to allow the spike interface cover 200 to be removed from the spike assembly 300 (via relative movement of the spike interface cover 200 and the spike assembly 300 away from each other and along an axial path). The indicated neutral position can correspond to a clamped, gripped, latched, or locked position (relative to the spike assembly 300) in which the head 324 of the spike interface cover 200 is latched or locked to the spike assembly 300, although the indicated latched or locked position can be somewhere between the neutral and open positions.

[0178] The spike interface cover 200 may include a stopper 211 for each clip 221, 223. The stopper 211 takes the form of a protrusion located on the outer periphery of the body 210 of the spike interface cover 200. The function of the stopper 211 is to (for example, when in the form of a living hinge) limit the movement of the clips 221, 223 relative to the spike body 210 to the elastic deformation range of the hinge 222. In any case, pinching pressure between the thumb and fingers of a user allows the clips 221 and 223 to be opened simultaneously to release the spike interface cover 200 from the spike assembly 300.

[0179] The upper or distal end 202 of the spike interface cover 200 includes a receptacle 204 (e.g., a concave space) into which at least a portion (e.g., a proximal section or portion) of the spike assembly 300 can be disposed in the assembled configuration. In this regard, the spike interface cover 200 includes a recessed base distal surface 206, which can be a flat or planar surface. A portion of each clip 221, 223 extends upward or distally beyond the base distal surface 206. A plurality of upper wall segments 230 also extend upward or distally from the base distal surface 206, projecting distally therefrom. The plurality of upper wall segments 230 are spaced apart from one another. One or more upper wall segments 230 are disposed between the clips 221, 223 on one side of the spike interface cover 200, and one or more upper wall segments 230 are disposed between the clips 221, 223 on the opposite side of the spike interface cover 200. In other words, one or more upper wall segments 230 run in one direction around the outer periphery of the spike interface cover 200 and are disposed between the clips 221, 223, and one or more of the upper wall segments 230 run in an opposite direction around the outer periphery of the spike interface cover 200 and are disposed between the clips 221, 223. Having multiple upper wall segments 230 disposed in spaced relation to one another on each side of the spike interface cover 200 provides an advantage or benefit of increasing the ability of the receptacle 204 to maintain / hold its overall shape (e.g., outer periphery profile) after manufacturing (compared to having a pair of continuous walls arranged in opposing relation to one another and replacing two sets of upper wall segments 230 (again, where each such set includes multiple upper wall segments 230 spaced apart from one another), including in the case of injection molded spike interface cover 200). This, in turn, increases the ability of the spike interface cover 200 to receive the spike assembly 300 in a desired manner. Having two different sets of plural upper wall segments 230 spaced apart from one another within each set and each set positioned opposite the other can be characterized as reducing the likelihood of ovalization of the outer perimeter of the receiving portion 204 during / after injection molding. The height of the upper wall segments 230, along with the protruding portions of the clips 221, 223, reduces the risk of contact with the punches 250, 260 (discussed below) of the spike interface cover 200. For example, such contact can be physical contact with a table or manual contact with a finger. That is, the perforators 250, 260 of the spike interface cover 200 are recessed relative to the distal ends or free ends of the heads 224 of the upper wall segments 230 / clips 221, 223, which may reduce the possibility of the perforators 250, 260 being contaminated when the spike interface cover 200 is installed on different spike assemblies 300, or in other words, the distal ends of each of the perforators 250 for the liquid passage and the perforators 260 for the air passage are disposed closer to the base distal surface 206 than the distal ends of each of the plurality of upper wall segments 230. The perforators 250 for the liquid passage and the perforators 260 for the air passage are located inside the outer perimeter collectively defined by the plurality of upper wall segments 230.

[0180] The spike interface cover 200 includes a liquid passageway 214 and an air passageway 261. The liquid passageway 327 of the spike assembly 300 and the air passageway 328 of the spike assembly 300 are fluidly connected to the liquid passageway 214 and the air passageway 261 of the spike interface cover 200, respectively. By opening / perforating the area of ​​the spike assembly 300 provided for this purpose, the active area 260 of the spike interface cover 200 accommodates the transfer of air from the exterior of the medical fluid container 400 to the interior of the medical fluid container 400. For example, the active area 260 of the spike interface cover 200 can be in the form of a perforator 260 that protrudes or extends distally from the base distal surface 206. The perforator 260 for the air passageway is fluidly connected to the air passageway 261. The perforator 260 for the air passageway includes an air passageway that intersects the exterior of the perforator 260 and forms a portion of the air passageway 261 of the spike interface cover 200. The distal end of punch 260 is also recessed relative to the distal ends of upper wall segment 230 and clips 221, 223. In other words, the distal end of punch 260 is located between base distal surface 206 and the distal ends of upper wall segment 230 and clips 221, 223 along the length dimension of spike interface cover 200 (punch 260 extends distally from base distal surface 206 in this length dimension).

[0181] When liquid is withdrawn from the medical fluid container 400, a vacuum is created, and external air (air outside the medical fluid container 400) needs to be drawn into the interior of the medical fluid container 400 to allow liquid to be dispensed from the medical fluid container 400 at a desired rate and / or in a desired amount of time. An air passageway 261 extends from a location on the exterior of the piercer 260 to another location on the exterior of the body 210 of the spike interface cap 200 (e.g., proximal to the piercer 260). Because the extraneous or external air flowing through the air passageway 216 arrives from an uncontrolled environment (ambient air), it should be filtered. In this regard, the spike interface cap 200 includes a filter 240 having an appropriate filter medium 242. The filter 240 can be overmolded relative to the body 210 of the spike interface cap 200, can be disposed in a filter port of the spike interface cap 200, or both. The filter 240 can be press-fit into an aperture in the body 210 of the spike interface cap 200 that is in direct communication with the air passageway 261. The diameter of the air passage 261 should be large enough, for example, about 1 mm or 1.5 mm, to allow sufficient air flow to limit the vacuum in the medical fluid container when liquid is dispensed from the medical fluid container 400 through the spike assembly 300, through the spike interface cap 200, through the container 100 and into the tube 60.

[0182] The active area 250 of the spike interface cap 200 is the portion that accommodates the extraction of liquid (e.g., for transfer to the syringe barrel of a syringe) from the interior of the medical fluid container 40 by opening / perforating an area provided in the spike assembly 300 for this purpose. The active area 250 of the spike interface cap 200 can take the form of a punch 250 that protrudes distally from the base distal surface 206 and includes a liquid passageway 214. The punching capability of the punch 250 can be enhanced by having a distal end or tip 252 in the form of a small (e.g., convex) radius 252. This radius can be approximately 0.05 mm. The distal tip or distal end of the punch 260 can be similarly defined. As with the punch 260, the distal end or tip 252 of the punch 250 is recessed relative to the distal ends of the upper wall segment 230 and the clips 221, 223. In other words, the distal tip 252 of the punch 250 is located between the base distal surface 206 and the distal ends of the upper wall segment 230 and clips 221, 223 along the length dimension of the spike interface cover 200 (the punch 250 extends distally from the base distal surface 206 in this length dimension).

[0183] The perforator 250 is provided with at least one passageway 251 that intersects the exterior of the perforator 250 and is in fluid communication with the liquid passageway 214 (the passageway(s) 251 extend the liquid passageway 214 and can be characterized as a portion of the liquid passageway of the spike interface cap 200). The use of multiple passageways 251 accommodates a reduction in the size (e.g., diameter) of the passageway 251 within the perforator 250 while still accommodating sufficient liquid flow rates from the medical container 400 and without adversely affecting the structural integrity of the spike interface cap 200 (and more specifically, the perforator 250) to an undesirable degree. Three passageways 251 can be utilized and evenly spaced (i.e., every 120°). The cross-sectional area through which fluid flows out of the medical fluid container 400 is critical to the pressure drop generated by the passage of the fluid. This is even more important in the transfer of medium-viscosity products (such as contrast agents). It is preferred to achieve an optimal compromise between the fluid flow cross-section and the outer diameter of the perforator 250. The larger the diameter of the punch 250, the more complex it is to integrate into the system - remember that it will also be desirable to have an adequate perimeter seal between the punch 250 and the interface 335 of the spike assembly 300 (e.g., Figure 10 , discussed below).

[0184] Figure 6The spike interface cap 200 is shown attached to the spike assembly 300, which is in turn mounted on a medical fluid container 400 (with a portion of the spike assembly 300 extending into the interior liquid-containing volume of the medical fluid container 400, i.e., the container piercer 340). The medical fluid container 400 generally includes a body 401 (e.g., glass) and a cap, closure, seal, plug, or septum 402 disposed in the outlet (e.g., the neck) of the container 400. The septum 402 can be formed of a flexible, deformable, and pierceable material and can be press-fit into the outlet of the container 400. The septum 402 can be retained relative to the body 401 of the medical fluid container 400 by an aluminum ring 403. The ring 403 can be partially removed when the medical fluid container 400 is in use and before the tubing 60 is connected.

[0185] The spike assembly 300, spike interface cap 200, container 100, and medical tubing 60 can be preassembled and provided in common packaging suitable for the application (e.g., to maintain sterility). However, the spike assembly 300 can be packaged separately, and the spike interface cap 200, container 100, and medical tubing 60 can be packaged separately together. Similarly, the spike assembly 300 directly interfaces with the medical fluid container 400. Figure 2 as well as Figures 7 to 11 The details of spike assembly 300 are discussed.

[0186] The spike assembly 300 assembly may be delivered in a blister pack 310 (eg, packaging) and as Figure 7 and Figure 8 The proximal end of the blister pack 310 may be made of porous paper or The porous side can be secured to the blister pack 310 at the flange 313. That is, the removable closure of the blister pack 310 is aligned with the side of the spike assembly 300 to which the spike interface cover 200 is mounted ( Figure 8 313).

[0187] After the proximal end of the blister pack 310 is opened by removing / peeling off the porous side (to expose the lower or proximal end of the spike assembly 300 disposed within the blister pack 310), the spike interface cover 200 and the spike assembly 300 can be removably interconnected. The blister pack 310 has a pair of oppositely disposed receivers 311 to receive the oppositely disposed clips 221 and 223 of the spike interface cover 200 to clip or latch the spike interface cover 200 onto the spike assembly 300. Thus, the blister pack 310, the spike assembly 300, the spike interface cover 200, the container 100, and the tube 60 can remain in a standby state (with the medical tube 60 connected to the syringe barrel) while awaiting puncture of a new medical fluid container 400.

[0188] The container piercer 340 and at least a portion of the spike body 320 of the spike assembly 300 (e.g., Figure 9 ) is kept free from contact with the blister pack 310 (and the surrounding environment). Liquid from the medical fluid container 400 flows through the container piercer 340 into the installed spike assembly 300, as will be discussed in greater detail below. Thus, the spike assembly 300 and spike interface cover 200 can be assembled in a more sterile manner. After removing the cover of the blister pack 310 and installing the spike interface cover 200 onto the spike assembly 300, the lower end of the spike assembly 300 need only be exposed for a short time. The blister pack 310 can be held in place on the spike assembly 300 by one or more small indentations or detents 312 that interfere with the two components (e.g., a pair of indentations 312 can provide an interference fit between the blister pack 310 and the spike assembly on opposite sides of the piercer 340 of the spike assembly 300). These small indentations 312 can be formed after the spike assembly 300 is placed in the blister pack 310 or pre-formed during the manufacturing process of the blister pack 310. In one embodiment, the blister pack 310 can be thermoformed. The blister pack 310 can also be made by injection molding (e.g., injection molding). The blister pack 310 can be removed from the spike assembly and then the spike assembly 300 can be installed on the medical fluid container 400.

[0189] The spike assembly 300 is Figure 9 and Figure 10 , and includes three main parts: the aforementioned container piercer 340, the aforementioned spike body 320, and a cover or end cap 330. The spike body 320 may include a base 370 having an upper or distal base surface 329 (e.g., flat or planar) and a piercer extension 380 extending distally from the base distal surface 329. The container piercer 340 protrudes distally relative to the aforementioned base distal surface 329. The container piercer 340 is disposed at or mounted to the distal end of the piercer extension 380. The container piercer 340 is thus spaced apart from the base distal surface 329 by a proximal section of the piercer extension 380 (e.g., the proximal section provides a seal between the spike assembly 300 and the septum 402 of the medical container 400—discussed in more detail below). The container piercer 340 and the piercer extension 380 may also be collectively referred to as a "piercer." The piercer extension 380 includes at least a portion of the liquid passageway 327 and at least a portion of the air passageway 328. The container piercer 340 is interconnected with the piercer extension 380.

[0190] The spike body 320 and the end cap 330 may be collectively referred to as the "first body" of the spike assembly 300. Such a "first body" may also include a piercer extension 380. In any case, the spike body 320 and the end cap 330 may be tightly connected, such as by bonding, ultrasonic welding, etc. A clip or snap-lock arrangement between the two parts 320 and 330 is also possible, but may require the use of a gasket. Any suitable means of attaching the spike body 320 to the end cap 330 may be utilized. The container piercer 340 and the spike body 320 may be coupled or clipped together (e.g., via a snap-lock arrangement). The piercer 340 may also be integrated into the spike body 320 (e.g., such that the container piercer 340 and the spike body 320 have a unitary structure; such that the single component is cast as one piece).

[0191] The spike assembly 300 is intended for use with a single medical fluid container 400. The spike assembly 300 is not intended to be installed on one medical fluid container 400 and then removed from that medical fluid container 400 and installed on another medical fluid container 400, which would increase the possibility of contamination / cross-contamination. The configuration of the spike assembly 300 reduces the likelihood of the spike assembly 300 being used on successive medical fluid containers 400. Generally, the spike assembly 300 is configured such that the amount of force required to detach / remove the entire spike assembly 300 from the medical fluid container 400 is greater than the amount of force required to detach the container piercer 340 from the spike body 320. The spike assembly 300 is configured such that the container piercer 340 will detach from the spike body 320 before the spike body 320 will detach from the medical fluid container 400 when the medical fluid container adapter assembly 40 is in the installed configuration. To further reduce the possibility of improper use of the spike assembly 300 and the spike assembly 300 being withdrawn from the medical fluid container 400 before piercing a new medical fluid container 400, the container piercer 340 is equipped with a proximal skirt. The function of the proximal skirt is to at least reduce the possibility of the container piercer 340 being withdrawn from the medical fluid container 400 (for example, incorporating a "harpoon" function into the structure of the container piercer 340). This harpoon function will be described in detail later.

[0192] The separation of the spike body 320 and the container piercer 340 can then be accomplished by the breakage area, the value of which will be predefined. Thus, by defining:

[0193] - F0: force to withdraw the standard spike from the medical container 400,

[0194] F1: force for withdrawing the container perforator 340 equipped with a harpoon function from the medical container 400,

[0195] - F2: force for decoupling the container piercer 340 and the spike body 320, F0 <F2<F1

[0196] Attempting to withdraw the spike assembly 300 from the medical fluid container 400 by applying a significant force to the spike assembly 300 will cause the container piercer 340 and the spike body 320 to become decoupled before the container piercer 340 is withdrawn from the septum 402 of the medical fluid container 400. Consequently, the container piercer 340 should remain within the interior of the medical fluid container 400. The spike assembly 300 without the container piercer 340 (after a portion thereof has been separated from the container piercer 340) cannot be used to pierce a new medical fluid container 400. The shape of the spike body 320 alone should not permit piercing of the septum 402 of the medical fluid container 400. In summary, the spike assembly 300 is configured such that the container piercer 340 should be separated from the remainder of the spike assembly 300 before the container piercer 340 can be withdrawn from the septum 402 of the medical fluid container 400 by attempting to pull the spike assembly 300 away from the medical fluid container 400 .

[0197] Figure 14 (discussed in more detail below) shows the forces F1 and F2 mentioned above. Figure 14 If a force is applied to the spike assembly 300 in the direction of the arrow of force F1 shown in FIG, the interface between the container piercer 340 and the septum 402 of the medical fluid container 400 will exert a force on the container piercer 340 along the Figure 14 The force F2 is in the direction of the arrow shown in FIG. Once the force is applied to the vessel piercer 340 through the interface with the diaphragm 402 (wherein the force is in the direction of the arrow Figure 14 When the container piercer 340 is separated from the spike body 320, the force in the direction of the arrow of force F1 that is continuously applied to the spike assembly 300 has not yet reached the magnitude of the force F1. Therefore, before the container piercer 340 can be completely withdrawn from the septum 402 (and with the container piercer 340 and the spike body 320 remaining intact), the container piercer 340 should be separated from the spike body 320.

[0198] Thus, the container piercer 340 of the spike assembly 300 performs two distinct functions—piercing the septum 402 of the medical container 400, and preventing withdrawal and, therefore, reuse of the spike assembly 300. The spike assembly 300 provides two levels of protection—increasing the standard withdrawal force of the piercer 340 (e.g., via the harpoon function described below), and decoupling the container piercer 340 from the spike body 320 if the force applied by the operator reaches a certain threshold.

[0199] As described above, the spike assembly 300 is attached to and retained on the spike interface cover 200 by the clips 221, 223 of the spike interface cover 200. These clips 221, 223 of the spike interface cover 200 are received in guides 323, 324, or channels, provided on the outer periphery of the spike body 320 of the spike assembly 300. Where the clips 221, 223 are provided in opposing relation to one another on the spike interface cover 200, the guides 323, 324 will similarly be provided in opposing relation to one another on the outer periphery of the spike assembly 300. The guides 323, 324 are in the form of recessed surfaces located on the outer periphery of the spike assembly 300, i.e., in the illustrated embodiment, on the outer peripheries of the spike body 320 and the end cap 330. Each guide 323, 324 extends from a lower or proximal end 334 of the spike assembly 300 (the ports 332, 333 having the interface 335 disposed thereon) toward (and including) a base distal surface 329 from which the container piercer 340 extends.

[0200] Each catch 321, 322 is disposed within a guide 323, 324. During the attachment or clipping phase, the clips 221, 223 (spike interface cover 200) slide within the corresponding guides 323, 324 (spike assembly 300) until they reach the corresponding catch 321, 322 (located on the outer periphery of the spike body 320 in the illustrated embodiment). The clips 221, 223 of the body 210 of the spike interface cover 200 removably engage the catches 321, 322, respectively, to removably connect the spike assembly 300 and the spike interface cover 200. The catches 321, 322 are spaced apart from one another. Each catch 321, 322 includes a ramp surface or ramp 325. Each ramp 325 extends away from a central reference axis of spike assembly 300 (corresponding to the length dimension of spike assembly 300—the dimension along which distal base surface 329 and proximal end 334 are spaced apart from one another) as it extends toward base distal surface 329. In other words, ramp 325 diverges relative to the central reference axis as it extends toward base distal surface 329. In the illustrated embodiment, the slope of surface 325 has a constant magnitude, although this may not be required for one or more applications.

[0201] The ramp 325 acts as a cam or cam surface for the clips 221 , 223 . Typically, as the spike interface cover 200 moves relative to the spike assembly 300 (e.g., along an axial path corresponding to the longitudinal or length dimension of the adapter assembly 40), engagement of the head 224 of the spike interface cover 200 with the corresponding ramp 325 of the spike assembly 300 will cause the head 224 to move (via movement of the clips 221, 223 in one direction about their respective hinges 222, which may also be provided by elastic deformation of the clips 221, 223 at their respective hinges 222) toward their respective open positions (away from the central reference axis of the adapter assembly 40) until the head 224 reaches the corresponding clipping or locking surface 326 of the spike assembly 300, at which point the head 224 moves back toward the central reference axis of the spike assembly 300 (via movement of the clips 221, 223 in the opposite direction about their respective hinges 222) (and may remain engaged with the corresponding surface 326) to clip, latch, or lock the spike interface cover 200 to the spike assembly 300. At this point, the base distal surface 206 of the spike interface cover 200 can engage the proximal end 334 of the spike assembly 300. This movement of the clips 221, 223 to their respective latched positions can also be provided by the elasticity of their corresponding hinges 222.

[0202] As noted, the medical container adapter assembly 40 can be configured such that the spike interface cap 200 can only be mounted on the spike assembly 300 in one orientation—with the piercer 250 (liquid) of the spike interface cap 200 disposed in the chamber 351 (liquid) of the spike assembly 300 and the piercer 260 (air) of the spike interface cap 200 disposed in the chamber 350 (air) of the spike assembly 300. The guides 323, 324 can be configured to accommodate only a single relative orientation between the spike assembly 300 and the spike interface cap 200 (when removably connected). This can be achieved by having guides 323 and 324 of the spike assembly 300 having different widths. In one embodiment, one of the guides is 1.5 times wider than the other. The same logic applies to spike interface caps 200 having clips 221, 223 of different widths. In any case, the positional registration function can be configured so that the (wider) head 324 of the clip 223 of the spike interface cover 200 cannot fit into the guide 323 of the spike assembly 300 (but can fit into the guide 324), thereby preventing one of two possible clamping or latching positions. The positional registration function is preferred because it directs the connection of the air passage 328 of the spike assembly 300 to the air passage 261 of the spike interface cover 200 to the air inlet, and it similarly directs the liquid passage(s) 327 of the spike assembly 300 to the liquid passage 214 of the spike interface cover 200 (here, the liquid passage 214 leads to the main barrel of the container 100).

[0203] Access and communication between the various passageways of the spike assembly 300 and the spike interface cover 200 is provided by perforations of an insert or interface 335 disposed on the proximal end 334 of the spike assembly 300 that interfaces with the spike interface cover 200 (and is incorporated into the end cap 330). The proximal end 334 of the spike body 320 is spaced apart from the base distal surface 329 of the spike body 320. The interface 335 can be overmolded onto the body 331 of the end cap 330, although the interface 335 can be integrated with the end cap 330 in any suitable manner. The interface 335 has a first hardness and the spike body 320 has a second hardness that is greater than the first hardness. The hardness of the interface 335 can be less than the hardness of the body 331 of the end cap 330. Typically, the interface 335 can be formed of a flexible / deformable material to engage with the perforators 250, 260 of the spike interface cover 200. In one embodiment, the hardness of the interface 335 is between 30 ShA and 90 ShA in one embodiment, between 50 ShA and 70 ShA in one embodiment, and about 60 ShA in yet another embodiment.

[0204] Interface 335 is configured to deform when perforator 250 for liquid passageway 214 of spike interface cap 200 is introduced into and through port 333 of interface 335. Interface 335 is also configured to deform when perforator 260 for air passageway 261 of spike interface cap 200 is introduced into and through port 332 of interface 335. Based on the positional registration function of medical container adapter assembly 40 discussed above, perforator 250 of spike interface cap 200 will be introduced into port 333 of interface 335 of spike assembly 300 and perforate a portion of interface 335 to accommodate fluid communication with liquid passageway(s) 327 of spike assembly 300, while perforator 260 of spike interface cap 200 will be introduced into port 332 of interface 335 of spike assembly 300 to accommodate fluid communication with air passageways 328, 348 of spike assembly 300. The "soft nature" of the interface 335 is part of the sealing nature of the contact between the interface 335 of the spike assembly 300 and the perforators 250, 260 of the spike interface cover 200. Typically, the interface 335 of the spike assembly 300 seals against the perimeter of the perforators 250, 260 of the spike interface cover 200. A sufficient seal between the interface 335 and the perforators 250, 260 is required to force all external air into the interior of the medical fluid container 400 by passing through the filter 240 of the spike interface cover 200 (through the vacuum in the medical fluid container 400), and similarly force the vacuum in the container 100 to draw liquid from the medical fluid container 400 (and not draw air from the external environment).

[0205] Before the punches 250, 260 of the spike interface cap 200 are introduced into the corresponding ports 333, 332 of the spike assembly 300, the diameter of the ports 333, 332 can be smaller than the outer diameter of the corresponding punches 250, 260. The expansion of the ports 333, 332 when the corresponding punches 250, 260 are introduced therein causes the interface 335 to expand (which provides a sealing aspect). The interface 335 can also be configured such that the punches 250, 260 need to pierce / pass through an aligned portion of the interface 335 before entering the corresponding chambers 351, 350 of the spike assembly 300 (and this provides another sealing aspect).

[0206] Various details of the container piercer 340 of the spike assembly 300 are also provided. Figure 13A 、 Figure 13B 、 Figure 13E and Figure 14 . The vessel piercer 340 can be characterized as including a distal tip 345, a frustoconical section or conical trunk 349, a first transition section 341, a second transition section 344a, and a body 344b. The frustoconical section 349 is located between the distal tip 345 and the first transition section 341 along the length dimension of the vessel piercer 340 (also corresponding to the spacing between the distal tip 345 and the base distal surface 329 of the vessel piercer 340 protruding proximally). When the spike interface cover 200 is removably coupled to the spike assembly 300, the first transition section 341 is located between the frustoconical section 349 and the reusable assembly including the spike interface cover 200. The first transition section 341 is located between the frustoconical section 349 and the second transition section 344a along the length dimension of the vessel piercer 340. The second transition section 344a is located between the first transition section 341 and the body 344b as it runs along the length dimension of the vessel piercer 340. Typically, the frustoconical section 349, the first transition section 341, the second transition section 344a, and the portion of the body 344b that extends from the second transition section 344a toward the upper base surface 329 (the distal portion of the body 344) are arranged in different orientations.

[0207] The distal tip 345 of the perforator 340 can be defined by a small radius. This radius of the distal tip 345 can be less than 0.15 mm, or can be less than 0.05 mm. In the case where an injection molding tool is used to form the spike assembly 300 (or at least the container perforator 340), this area of ​​the injection molding tool (used to define the distal tip 345) can be filled with a moving area (such as a spindle). The radius of the distal tip 345 can advantageously be tangent to the section 349, and wherein the section 349 can be tangent to such a radius that defines where the air passage 348 incorporated by the container perforator 340 intersects the exterior of the container perforator 340 (e.g., Figure 13A) and will be discussed in more detail below.

[0208] The frustoconical section 349 can be configured to diverge relative to a central reference axis of the vessel piercer 340 (centrally located and aligned with the length dimension of the vessel piercer 340) as it extends in a direction (e.g., proximally) along the first transition section 341. The frustoconical section 349 can be defined by a constant slope. The piercing function of the piercer 340 is improved by the configuration of the first transition section 341 and the small radius defining the distal tip 345. This can collectively facilitate piercing by concentrating force on the first tenth of the puncture. In this regard, the first transition section 341 is concave on the exterior of the vessel piercer 340 and along the length dimension of the vessel piercer 340 (e.g., the first transition section 341 includes a "knee" portion extending along the length dimension of the vessel piercer 340). In other words, the transition section 341 is a concave surface located on the exterior of the vessel piercer 340 that extends proximally relative to the frustoconical section 349.

[0209] The vessel piercer 340 further includes a passage 348 that intersects the perimeter of the vessel piercer 340 at least in the first transition section 341 (e.g., in one or more embodiments, also in the second transition section 344a). The passage 348 extends into the vessel piercer 340 to the passage 328, which intersects the perimeter of the piercer extension 380 on which the vessel piercer 340 is positioned ( Figure 13E ). The passageway 328 extends along / through the punch extension 380 to the interior chamber 350 in the spike body 320. (e.g., Figure 6 and Figure 15A ). A plurality of elongated windows 343 (e.g., recessed structures) are circumferentially spaced about the outer periphery of the container piercer 340. Any suitable number of windows 343 may be utilized (three in the illustrated embodiment). Each window 343 accommodates the flow of liquid from the medical fluid container 400 through a corresponding mouth or port 343a (e.g., disposed proximally in the corresponding window 343) and into one or more passageways 327 in the piercer extension 380 (e.g., Figures 15A to 15C), the one or more passages extend along / through piercer extension 380 and are discussed in greater detail below. When medical container assembly 20 is oriented so that container piercer 340 of spike assembly 300 projects upward (e.g., with medical fluid container 400 positioned above base 370 of spike body 320), the intersection of passage 348 (air outlet for medical fluid container 400) with the exterior of container piercer 340 should be at least at the same height as the mouth or port 343a of each window 343 (liquid inlet for spike assembly 300), but more preferably, the intersection of passage 348 (air outlet for medical fluid container 400) with the exterior of container piercer 340 should be at a higher height than the mouth or port 343a of each window 343 (liquid inlet for spike assembly 300).

[0210] The selection of a material with a relatively low injection grade can be used for the container piercer 340 and thus helps to properly form the tapered shape of the distal section of the container piercer 340. Methyl methacrylate-acrylonitrile-butadiene-styrene (MABS), polybutylene terephthalate (PBT), polycarbonate (PC), or a polyolefin-based material can be used to manufacture the container piercer 340. Polyolefin- or PBT-based materials can be selected for manufacturing the container piercer 340 because they have a low coefficient of friction and therefore better sliding properties during piercing of the septum 402 of the medical fluid container 400.

[0211] Figure 13A Detail of the proximal end section of the vessel piercer 340 is presented. The proximal end of the vessel piercer 340 can be characterized as a corolla-shaped base equipped with serrations, tabs, or retaining sections 342, and the proximal end of the vessel piercer 340 can be characterized as a stopper for the vessel piercer 340. Preferably, the vessel piercer 340 includes at least three such retaining sections or tabs 342 spaced apart from one another. The vessel piercer 340 extends along a reference axis, and the tabs 342 extend away from the reference axis as they proceed toward the base surface 329 of the spike assembly 300. A slit 347 is provided between each pair of adjacent tabs 342. In other words, the tabs 342 are disposed around the periphery of the proximal end of the vessel piercer 340 and are spaced apart from one another. Any suitable number of protrusions 342 may be utilized, any suitable spacing between pairs of adjacent protrusions 342 may be utilized, or both. Typically, the protrusions 342 are deflectable (eg, resilient) structures.

[0212] The protrusions 342 of the container piercer 340 can be characterized as being cantilevered. That is, each protrusion 342 has a free end 346 that is spaced apart from the base surface 329 of the spike assembly 300 and corresponds to the proximal end of the container piercer 340. Each protrusion 342 can extend divergently relative to the longitudinal axis of the spike assembly 300 as it progresses toward its corresponding free end. The protrusions 342 can be curved as they progress along their respective length dimensions. In other words, the protrusions 342 can be characterized as defining a flared proximal portion of the container piercer 340. In any case, a space 352 is provided between the protrusion 342 and the piercing extension 380 (e.g., a space adjacent to and radially inward of the protrusion 342). The space 352 is an open space adjacent to and radially inward of each protrusion 342. The proximal section of each projection 342 curves away from the reference axis as it extends to the corresponding free end 346. In other words, at least the proximal section of the projection 342 and the punch extension 380 can be disposed in a radially spaced relationship with each other. Figure 13E A space 352 is shown between the projection 342 and the outer perimeter of the piercer extension 380 of the spike body 320 , which allows the serration 342 to elastically deform in the direction of the piercer extension 380 .

[0213] An advantage associated with including the protrusion 342 in the container piercer 340 is that it allows the container piercer 340 to temporarily elastically deform when entering the septum 402 of the medical fluid container 400. When the container piercer 340 is located in the material of the septum 402, it can withstand a radial force between 10N and 30N in the coronal region of the container piercer 340 (e.g., the region including the protrusion 342) and, through elastic deformation, is forced to displace (e.g., the serrations or protrusions 342 bend radially inward), which has the effect of reducing the effective outer diameter of the proximal end of the container piercer 340 (collectively defined by the protrusion 342). This can occur by eliminating the slit 347 and allowing for serration-to-serration contact (e.g., the protrusion 342 can now contact the piercer extension 380). This reduction in the effective outer diameter of the proximal end of the container piercer 340 tends to reduce the piercing force. When the protrusions 342 of the piercer 340 are open on the other side of the septum 402 (inside the medical container 400) and are not in contact with the material of the septum 402, the protrusions 342 should move back toward their undeformed state due to the elasticity of the protrusions 342 (which increases the effective outer diameter of the proximal end of the container piercer 340 but is now located inside the medical fluid container 400). This increases the interference between the container piercer 340 and the septum 402 of the medical fluid container 400, making it more difficult to withdraw the container piercer 340 back out of the interior of the medical fluid container 400 through the septum 402. This interference can be characterized as the protrusions 342 being in a "resting" position (e.g., when no external force is applied to the protrusions 342 (e.g., Figure 13C ), such as when disposed within the open interior space of the medical fluid container 400, and the outer diameter of the protrusion 342 when it is disposed against the outer periphery of the piercer extension 380 of the spike body 320 (as the spike assembly 300 is being mounted on the container 400 through engagement of the septum 402 with the protrusion 342).

[0214] like Figure 13AAs shown, the corolla shape with the elongated serrations 342 can be characterized as providing a harpoon function to the container piercer 340. While maintaining the same flexibility, the longer serrations 342 allow for an increased initial diameter and greater interference with the septum 402 of the medical container 400 after opening. The container piercer 340 can be configured such that if an attempt is made to withdraw the container piercer 340 from the medical container 400 without separating it from the rest of the container piercer 340, the serrations 342 on the inside of the septum 402 of the medical fluid container 400 will be perpendicular to the inside of the septum 402. In any event, and once the protrusions 342 are no longer obstructed by the inside of the septum 402 of the medical container 400, the septum 402 will engage the outer periphery of the piercer extension 380 to provide an adequate seal between the medical fluid container 400 and the spike assembly 300 during injection.

[0215] Figure 13C and Figure 13D A variation of the container piercer 340 is presented and is therefore identified by reference numeral 340'. Corresponding components between the container piercer 340 and the container piercer 340' are identified by the same reference numerals, and unless otherwise indicated, the discussion presented herein regarding the container piercer 340 still applies equally to the container piercer 340'. The container piercer 340' is configured to further reduce the force required for the container piercer 340' to pierce the septum 402 of the medical fluid container 400. Typically, a plurality of longitudinally extending (e.g., elongated), circumferentially spaced channels 360a (e.g., recessed structures) are formed on the outer surface or outer periphery of the container piercer 340'. Each pair of adjacent channels 360a can be characterized as defining a corresponding indentation 360. In the illustrated embodiment, the width of the elongated channels 360a gradually increases as they extend distally toward the distal tip 345 of the container piercer 340'. The width of each elongated channel 360a gradually decreases as it extends proximally away from the end closest to the distal tip 345 of the container piercer 340. Thus, the width of the grooves 360 gradually decreases as it extends distally in the direction of the distal tip 345, thereby reducing the contact surface between the container piercer 340' and the septum 402 of the medical fluid container 400 (and thus reducing the amount of force required to guide the container piercer 340' through the septum 402 of the medical fluid container 400).

[0216] The grooves 360 can extend at least substantially in the longitudinal dimension from the base of the serrations 342 to the proximal end of the passageway 348 (air) where it intersects the exterior of the container piercer 340'. The container piercer 340' can utilize any suitable number of grooves 360 and any suitable spacing between each pair of adjacent grooves 360. In one embodiment, twelve grooves 360 are utilized, with four grooves 360 disposed between each pair of adjacent windows 343 utilized by the container piercer 340' (three windows 343 in one embodiment of the container piercer 340'). Compared to the container piercer 340, the container piercer 340' can reduce the contact surface with the septum 402 of the medical fluid container 400 by a factor of two via the passage 360a and the corresponding grooves 360.

[0217] Another variation of the container piercer 340 is shown in Figure 11 and Figure 12 340'. Corresponding components between the vessel piercer 340 and the vessel piercer 340' are identified by the same reference numerals, and unless otherwise indicated to the contrary, the discussion presented herein with respect to the vessel piercer 340 remains equally applicable to the vessel piercer 340'. The vessel piercer 340' does not utilize the first transition section 341 described above. While the vessel piercer 340' does utilize a plurality of protrusions 342' at its proximal end, these protrusions 342' do not define a "flared" proximal end section in the case of the vessel piercer 340'. However, the vessel piercer 340' is still configured to be separated from the piercer extension 380 of the spike body 320 (or more generally from the spike body 320) in the manner described above to, for example, reduce the likelihood of reuse of the spike assembly utilizing the piercer 340'.

[0218] Liquid flows out of the medical fluid container 400 and flows through the spike assembly 300, along with the external air flowing through the spike assembly 300 and into the medical container 400. Figures 15A to 15C and Figure 16Spike assembly 300 also includes an internal chamber 350 (air) and an internal chamber 351 (liquid), each of which is disposed within spike body 320, more specifically within base 370 thereof. Liquid chamber 351 is fluidly connected to liquid passageway 327, and air chamber 350 is fluidly connected to air passageways 328, 348. Liquid in medical fluid container 400 flows through port 343a in window 343 of container piercer 340, into one or more passageways 327 in piercer extension 380 of spike body 320, and into chamber 351 in base 370 of spike body 320. With spike interface cap 200 removably attached to spike assembly 300, liquid passageway 214 of spike interface cap 200 is fluidly connected to liquid chamber 351, and air passageway 261 of spike interface cap 200 is fluidly connected to air chamber 350. The perforator 250 for the liquid passage extends into the liquid chamber 351, and the perforator 260 for the air passage extends into the air chamber 350. The liquid in the chamber 351 of the spike assembly 300 flows into one or more passages 251 (e.g., Figure 16 ), enters the liquid passage 214 of the spike interface cover 200, enters the container 100, and enters the tube 60. External air can flow into the spike interface cover 200 through the filter 240 (and filter medium 242), through the passage 261 of the perforator 260 for the spike interface cover 200, and enter the chamber 350 (e.g., Figure 16 ), into the passage 328 of the piercer extension 380, into the passage 348 of the container piercer 340, and into the medical fluid container 400.

[0219] With the spike interface cover 200 removably connected to the spike assembly 300: 1) the piercer 250 (liquid) of the spike interface cover 200 extends through the port 333 of the interface 335 (incorporated by the end cap 320) and into the chamber 351 of the spike assembly 300 (e.g., Figure 6 ); and 2) the perforator 260 (air) of the spike interface cover 200 extends through the port 332 of the interface 335 (incorporated by the end cap 320) and into the chamber 350 of the spike assembly 300 (e.g., Figure 6 ). The interface 335 of the spike assembly 300 including ports 332, 333 is shown in FIG. Figure 17 and Figure 18 (and one or more of the previously mentioned figures, such as Figure 15A). The body 331 of the end cap 330 can be made of ABS, MABS, PC or PA type thermoplastics, while the interface 335 of the end cap 330 can be made of SEBS, silicone or other soft materials with good deformability and low residual stress to seal the functional area of ​​the chamber cover. The interface 335 can be overmolded to the body 331 at the lower end or proximal end of the end cap 330 (corresponding to the lower end or proximal end 334 of the spike assembly 330), or these components can be combined together. Overmolding the interface 335 to the body 331 provides the advantage of providing an enhanced seal between the two components.

[0220] like Figure 15A As shown in FIG, a perforable wall 332a, 333a is provided in each port 332, 333 and initially isolates each port from the corresponding chamber 350, 351, respectively. Each perforable wall 332a, 333a may be concave on a side facing the corresponding perforator 260, 250, respectively, of the spike interface cover 200. Such a concave shape of the perforable wall 332a, 333a (e.g., see FIG. Figure 19D ) and their respective thicknesses are adapted to facilitate perforation during connection of the spike interface cover 200 to the spike assembly 300 and to facilitate reclosing after the spike interface cover 200 is disconnected from the spike assembly 300. When the spike interface cover 200 is removably connected to the spike assembly 300 (with the perforator 250 (liquid) of the spike interface cover 200 extending into the port 333, through the corresponding perforable wall 333a, and into the chamber 351; and with the perforator 260 (air) of the spike interface cover 200 extending into the port 332, through the corresponding perforable wall 332a, and into the chamber 350), the interface 335 of the spike assembly 300 seals against the outer perimeter of each of the perforators 250, 260 of the spike interface cover 200.

[0221] Variations of end cap 330 (e.g., Figures 17 and 18 ) is displayed in 19A to 19D 330'. Corresponding components between end cap 330 and end cap 330' are identified with the same reference numerals, and unless otherwise indicated herein, the discussion presented herein with respect to end cap 330 remains equally applicable to end cap 330'. Generally, end cap 330' utilizes a different configuration for interface 335' (compared to end cap 330), and further improves the piercing and sealing functions by creating a pre-cut or broken shape that guides the piercers 250, 260 of the spike interface cover 200 to open the material during piercing.

[0222] The interface 335' includes the aforementioned ports 332 (air) and 333 (liquid), into which the perforators 260 and 250 of the spike interface cover 200 can be respectively guided to engage corresponding perforated sections 336 of the interface 335'. ​​The perforated sections 336 of the interface 335' are each configured to separate in a predetermined manner (e.g., into segments 337; along predetermined separation lines 339 between each pair of adjacent segments 337) when engaged by corresponding perforators 250, 260 of the spike interface cover 200. These segments 337 can be manufactured, post-injected, or reworked, for example, by cutting in the engaged lip with a blade, or by creating a shape in the injection mold during the injection process. These segments 337 will create a thin thickness in the interface 335', ​​and these thin areas have the function of separating and guiding the interface 335' opening in a predetermined manner.

[0223] 19A to 19D Shown is a segment 337 with a triangular configuration. Each port 332, 332 can use any appropriate number of segments 337 (four in the illustrated embodiment). Chamfers 338 can be included on the side of each segment 337 adjacent to another segment 337. These chamfers 338 can be characterized as: the function provided is to guide pairs of adjacent segments 337 to tear or separate from each other, to guide interface 335' to deform, perforate or "open" by corresponding perforators 250, 260, or both. Chamfers 338 can be characterized as forming the corresponding thin-walled section of interface 335' in the following manner, and this mode is to provide interface 335' to the desired sealing of corresponding perforators 250, 260 by predetermined and / or controlled separation (separation occurs along each thin-walled section-separation line 339) of interface 335'.

[0224] During the perforation of the interface 335', ​​the punches 250, 260 of the spike interface cover 200 will contact the center of the triangular segment 337 and the cross (the intersection of the two separation lines 339 of each port 332, 333, as shown in FIG. Figure 19C The pointed shape of the perforator will pierce the thin material area and gradually tear along the contour until the correct diameter ( Figures 19B to 19D The interface 335' of the end cap 330' is shown, particularly showing the thinner wall thickness in the controlled tear area (corresponding to the separation line 339). The slight tear resistance of the material will open the opening sufficiently to allow the perforators 250, 260 to pass through, while ensuring the perimeter tightness and thus the seal. When the spike interface cover 200 is disconnected from the spike assembly using the interface 335', ​​the shape will gradually withdraw from the part 335, and the shape memory will cause the groove to gradually close again, which will provide an adequate seal for the corresponding medical fluid container 400.

[0225] Figure 20 and Figure 21Spike assembly 300 is shown installed on medical fluid container 400, but spike interface cap 200 is not attached to spike assembly 300. For example, this may be the configuration of medical container assembly 20 in the following situations: after a sufficient amount of liquid in medical fluid container 400 has been used (e.g., transferred from medical fluid container 400 via spike assembly 300, spike interface cap 200, container 100, and tube 60), and when medical fluid container 400 (with spike assembly 300 still installed thereon) is replaced with another medical fluid container 400, and a new spike assembly 300 is to be installed on this new medical fluid container 400 according to the above description, and spike interface cap 200 is to be attached to this new spike assembly 300. In this regard and at the end of withdrawing liquid from medical fluid container 400 (e.g., at the end of withdrawing liquid from medical fluid container 400), the spike assembly 300 is to be used. Figure 1 and Figure 6 226 on the outer periphery of spike assembly 300). Upon withdrawal, once the perforators 250 and 260 of the spike interface cap 200 are withdrawn from the interface 335 of the spike assembly 300, the holes previously created in the interface 335 by the perforators 250, 260 should close and seal the spike assembly 300 to reduce the likelihood of fluid leaking from the medical fluid container 400 through the spike assembly 300. The medical fluid container 400 can then be discarded (with the spike assembly 300 remaining mounted thereon), reducing the risk of discharge or spillage of residual product from the medical fluid container 400.

[0226] As will be appreciated from the foregoing, a medical container adapter assembly solves one or more problems. One is that the container piercer of the adapter assembly can incorporate multiple different features to reduce the amount of force required to install the spike assembly on the medical fluid container. Another is that the spike assembly can incorporate multiple different features to reduce the chance of being able to reuse the same spike assembly on multiple medical fluid containers, which can reduce the possibility of contamination. Another is that the spike assembly, the spike interface cover, or both can incorporate one or more features to reduce the possibility of contamination before the spike interface cover is removably connected to the spike assembly. Yet another is that the spike interface cover can incorporate multiple different features to allow the same spike interface cover to be reused with multiple spike assemblies / medical fluid containers.

[0227] The above description of the present invention is provided for the purpose of illustration and description. In addition, this description is not intended to limit the invention to the form disclosed herein. Therefore, changes and modifications commensurate with the above teachings and the skills and knowledge of the relevant fields are within the scope of the present invention. The embodiments described above are also intended to explain the known best mode of practicing the present invention and to enable others skilled in the art to utilize the present invention in this or other embodiments and use it together with various modifications required for the (multiple) specific applications or (multiple) uses of the present invention. The appended claims are intended to be interpreted as including alternative embodiments to the extent permitted by the prior art.

Claims

1. A medical fluid container adapter assembly, comprising: a first connector portion comprising a container piercer, a first liquid passageway and a first air passageway, and a first body, the first body in turn comprising a first base distal surface, wherein the container piercer projects distally relative to the first base distal surface and comprises a distal tip, an exterior, the first liquid passageway and the first air passageway, and wherein the first connector portion is connectable to a medical fluid container, wherein the first connector portion is a disposable connector portion, wherein the container piercer comprises a proximal section that provides a harpoon function to the container piercer; and a multi-use assembly removably connected to the first connector portion, wherein the multi-use assembly includes a medical tubing interface and a second connector portion, the second connector portion including a second liquid passageway and a second air passageway, and wherein the first liquid passageway and the first air passageway of the container piercer of the first connector portion are fluidly connected to the second liquid passageway and the second air passageway of the second connector portion, respectively, wherein the first body further includes a base and a piercer extension, the base including the first base distal surface, the piercer extension extending distally from the first base distal surface and including the first liquid passage and the first air passage, and the container piercer is interconnected with the piercer extension such that when the medical fluid container adapter assembly is in the installed configuration, the container piercer will be separated from the first body before the first body is separated from the medical fluid container.

2. The medical fluid container adapter assembly of claim 1, wherein: The proximal section of the container piercer comprises a corolla-shaped base equipped with a retaining section.

3. The medical fluid container adapter assembly of claim 1, wherein: The second connector part includes clips movably integrated with the second body of the second connector part and configured to removably engage the first connector part.

4. The medical fluid container adapter assembly of claim 1, wherein: The second connector portion includes a second base distal surface, a perforator for the second liquid passage, and a perforator for the second air passage, wherein the perforator for the second liquid passage protrudes distally from the second base distal surface, is connected to the second liquid passage fluid, and is connected to the first liquid passage fluid of the first connector portion, and wherein the perforator for the second air passage protrudes distally from the second base distal surface, is connected to the second air passage fluid, and is connected to the first air passage fluid of the first connector portion.

5. The medical fluid container adapter assembly of claim 4, wherein: The first body includes a liquid chamber fluidly connected to the first liquid passage and an air chamber fluidly connected to the first air passage, wherein the second liquid passage of the second connector part is fluidly connected to the liquid chamber, and the second air passage of the second connector part is fluidly connected to the air chamber, wherein the perforator for the second liquid passage extends into the liquid chamber, and wherein the perforator for the second air passage extends into the air chamber.

6. The medical fluid container adapter assembly of claim 4, wherein: The second connector portion further includes a plurality of upper wall segments that are spaced apart from each other and protrude distally from the second base distal surface of the second connector portion, the perforator for the second liquid passage and the perforator for the second air passage being located inside an outer periphery jointly defined by the plurality of upper wall segments, and a distal end of each of the perforator for the second liquid passage and the perforator for the second air passage being arranged to be closer to the second base distal surface than a distal end of each of the plurality of upper wall segments.

7. The medical fluid container adapter assembly of claim 5, wherein: The first body includes a proximal end spaced apart from the first base distal surface of the first body, the first connector part includes a first interface arranged on the proximal end of the first body and connected to the second connector part, the first interface has a first hardness and the first body has a second hardness greater than the first hardness, the first interface includes a first perforable section in the flow path leading to the first liquid passage and a second perforable section in the flow path leading to the first air passage, the perforator for the second liquid passage extends through the first perforable section and into the liquid chamber, and the perforator for the second air passage extends through the second perforable section and into the air chamber.

8. The medical fluid container adapter assembly of claim 4, wherein: The container piercer extends along a first reference axis and includes at least three retention segments that are spaced apart from each other, extend away from the first reference axis as they extend in a direction toward the first base distal surface of the first connector portion, and have free ends spaced apart from the first base distal surface of the first connector portion, wherein an open space is adjacent to and radially inward of each of the retention segments, and wherein a proximal segment of each of the retention segments curves away from the first reference axis as it extends to the corresponding free end.

9. The medical fluid container adapter assembly of claim 1, wherein: The first body includes a first catch and a second catch spaced apart from each other, wherein the second connector part includes a second body and a first clip and a second clip, the first clip and the second clip being movable relative to the second body and respectively detachably engaging the first catch and the second catch to detachably connect the first connector part and the second connector part, wherein the first catch and the second catch are arranged on the outer periphery of the first body.

10. The medical fluid container adapter assembly of claim 9, wherein: The first body includes a first channel and a second channel disposed on the outer periphery of the first body, wherein the first buckle and the second buckle are disposed in the first channel and the second channel respectively.

11. The medical fluid container adapter assembly of claim 10, wherein: The first channel and the second channel are configured to accommodate only a single relative orientation between the first connector portion and the second connector portion when removably connected.

12. The medical fluid container adapter assembly of claim 1, wherein: The container piercer includes a frustoconical section and a transition section, wherein the frustoconical section is arranged between the distal end and the transition section, the transition section is located between the frustoconical section and the multi-use component, and the transition section is a concave surface located on the exterior of the container piercer and extends proximally relative to the frustoconical section.

13. The medical fluid container adapter assembly of claim 1, wherein: The vessel piercer further includes a plurality of elongated liquid inlet channels spaced apart from one another and recessed on the exterior of the vessel piercer, wherein each of the elongated liquid inlet channels is fluidly connected to the first liquid passageway.

14. The medical fluid container adapter assembly of claim 1 , further comprising a plurality of elongated channels spaced apart from one another and recessed on the exterior of the container piercer, wherein: The width of each of the plurality of elongated channels gradually increases as it extends distally toward the distal tip of the vessel piercer.

15. The medical fluid container adapter assembly of claim 1, wherein: The first air passageway intersects the exterior of the container piercer closer to the distal tip than the first liquid passageway intersects the exterior.

16. The medical fluid container adapter assembly of claim 1, wherein: The container piercer is spaced apart from the first base distal surface by a proximal section of the piercer extension that provides a sealing location between the first connector portion and the septum of the medical fluid container.

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