Injection setup kit and method

Abstract

The infusion setup kit may include a manifold connector, a first packaging container, and a fluid line. The first packaging container may define a first closed internal volume including a patient interface connector having a patient interface inlet, a first patient interface outlet, and a valve configured to selectively allow fluid communication through the patient interface connector. The patient interface inlet may be fluidly connected to the manifold outlet. The fluid line may have a first fluid line end and a second fluid line end. The first fluid line end may be connected to the patient interface inlet within the first closed internal volume. The second fluid line end may extend outside the first closed internal volume and be connected to the manifold outlet outside the first closed internal volume.

Description

Technical Field

[0001] [Related Applications] This application claims the priority of U.S. Patent Application No. 17 / 006973, filed on August 31, 2020, the content of which is incorporated herein by reference.

[0002] [Technical Field] The present disclosure generally relates to the field of medical technology, and more particularly to kits and methods for infusion systems.

Background Art

[0003] Infusion systems can be used for various medical applications. For example, an infusion system can be used to introduce a fluid into a patient to facilitate medical diagnosis and / or intervention procedures. In some such procedures, this fluid can assist in collecting information such as image data in the region of interest within the patient. This collected information can be used to confirm characteristics related to the diagnostic procedure and / or to guide the placement of one or more medical devices during the intervention procedure.

[0004] However, properly setting up an infusion system can require considerable time and attention. Setting up an infusion system may involve connecting many components. For example, some infusion system components are intended for a limited number of uses (e.g., single use) and need to be replaced frequently. In addition, in some cases, after the components are connected, setting up the infusion system may require certain actions before the fluid can be introduced into the patient. One such action may be air purging, which allows the fluid to pass through the connected infusion system components and remove any air trapped in them. In some cases, to maintain the sterility of certain components, some setting actions may be performed by non-sterile users, while others are performed by sterile users. Thus, properly setting up an infusion system can require considerable time and attention from multiple users. [Overview of the project]

[0005] In general, various embodiments relating to infusion setup kits and methods are disclosed herein. Such various embodiments may be useful in facilitating more efficient workflows, for example, when preparing a fluid infusion system for use. Embodiments disclosed herein may allow the components of a fluid infusion system to be set up while maintaining the sterility of certain components before an application in which a fluid injector is required. In particular, embodiments disclosed herein may allow certain components to be pre-set up while the procedural environment is relatively calm, as this setup may occur before an emergency where time pressure will be present. This significantly reduces the time and care required to make the infusion system ready for use if the need to use the fluid infusion system arises later. This can be particularly valuable in fluid infusion applications where time is critical. For example, in some applications, a matter of a few seconds may be the difference between a successful procedure and irreversible anatomical trauma (e.g., irreversible myocardial trauma). Embodiments disclosed herein can therefore increase the likelihood of a procedure succeeding by reducing the time required to prepare the infusion system for use in the procedure.

[0006] One embodiment includes an infusion setup kit. This embodiment of the infusion setup kit includes a manifold connector, a first packaging container, and a fluid line. The manifold connector includes a first manifold inlet and a manifold outlet. The first packaging container defines a first closed internal volume. This first closed internal volume may include a patient interface connector, which has a patient interface inlet, a first patient interface outlet, and a valve configured to selectively allow fluid to be communicated through the patient interface connector from the patient interface inlet to the first patient interface outlet. The patient interface inlet may be fluidically connected to the manifold outlet. The fluid line may have a first fluid line end and a second fluid line end. The first fluid line end may be connected to the patient interface inlet within the first closed internal volume of the first packaging container. The second fluid line end may extend outside the first closed internal volume of the first packaging container and may be connected to the manifold outlet outside the first closed internal volume of the first packaging container.

[0007] Further embodiments of the injection setup kit include a second packaging container separate from the first packaging container. In this embodiment, the second packaging container defines a second closed internal volume, which may include a manifold connector. The second fluid line end may extend outside the first closed internal volume of the first packaging container and into the second closed internal volume of the second packaging container, so that the second fluid line end is connected to a manifold outlet in the second closed internal volume of the second packaging container.

[0008] Another embodiment includes a method for setting up the injection system. An embodiment of this method includes the steps of opening a first packaging container and removing a manifold connector from the first packaging container. The manifold connector removed from the first packaging container may include a first manifold inlet and a manifold outlet. The manifold outlet of the manifold connector removed from the first packaging container may be connected to one end of a fluid line, and the other end of the fluid line may extend into the closed internal volume of a second packaging container. After the step of opening the first packaging container, an embodiment of this method includes the step of fluidically connecting the first manifold inlet to a contrast fluid reservoir. The contrast fluid reservoir may define a first internal reservoir volume including a first plunger. After the step of connecting the first manifold inlet to the contrast fluid reservoir, an embodiment of this method includes the step of delivering the contrast fluid from the contrast fluid reservoir along a fluid line to a fluid collection receptacle located in the closed internal volume of the second packaging container. After the step of delivering the contrast fluid to the fluid recovery container, embodiments of this method include the steps of opening a second packaging container and removing from the second packaging container the other end of the fluid line, the fluid recovery container, and the patient interface connector that is in fluid communication with the fluid line. And, after the step of opening the second packaging container, embodiments of this method include the step of fluidically connecting the patient interface connector to the infusion catheter.

[0009] Details of one or more examples are shown in the attached drawings and the following description. Other features, purposes, and advantages will become apparent from the specification and drawings.

[0010] [Brief description of the drawing] The following drawings illustrate specific embodiments of the present invention and are therefore not intended to limit the scope of the invention. The drawings are intended to be used in conjunction with the description in the following specification. Embodiments of the present invention are described below together with the accompanying drawings, where the same numbers indicate the same elements. [Brief explanation of the drawing]

[0011] [Figure 1] This is a perspective view of one embodiment of a fluid injector. [Figure 2] This is a schematic diagram showing one embodiment of an injection setting kit, including an exemplary first packaging container and an exemplary second packaging container. [Figure 3] Figure 2 is a schematic diagram showing the first packaging container, but with the second packaging container removed. Figure 3 shows the components that were previously surrounded by the second packaging container and connected to the corresponding components of the injection system. [Figure 4] Figure 2 is a schematic diagram showing the state with both the first and second packaging containers removed. Figure 4 shows a component that was previously surrounded by the second packaging container and connected to the corresponding component of the infusion system. Figure 4 also shows a component that was previously surrounded by the first packaging container and connected to the infusion catheter. [Figure 5] This is a schematic diagram showing another embodiment of the injection setting kit, including an exemplary first packaging container and an exemplary second packaging container. [Figure 6] This is a schematic diagram illustrating further embodiments of the injection setting kit, including an exemplary first packaging container and an exemplary second packaging container. [Figure 7] This is a flowchart of one embodiment of the method for setting up the injection system. [Modes for carrying out the invention]

[0012] The following detailed description is essentially illustrative and is not intended to limit in any way the scope, applicability, or configuration of the invention. Rather, the following description provides several practical examples for carrying out embodiments of the invention. Examples of structures, materials, and / or dimensions are given for selected elements. Those skilled in the art will recognize that many of the examples mentioned have various suitable alternatives.

[0013] Figure 1 shows a fluoroscopic view of an exemplary embodiment of the fluid injector 100. In operation, the fluid injector 100 can inject a certain amount of fluid into the patient's blood vessels, for example, via a catheter. The fluid injected by the fluid injector 100 may be, for example, a contrast fluid, a non-contrast fluid (e.g., a saline solution), or a combination thereof. By injecting a quantity of fluid into the patient's body, the fluid injector 100 can facilitate a variety of medical diagnostic and / or interventional procedures, including the collection of imaging data representing an anatomical region of interest. Such procedures may include, by example, optical coherence tomography (OCT) images, intravascular ultrasound (IVUS) images, computed tomography (CT) images, magnetic resonance imaging (MRI), angiography procedures, and interventional device procedures / setups.

[0014] The illustrated fluid injector 100 includes a drive assembly housing 102 and a sleeve 104. The sleeve 104 may be fixed to the drive assembly housing 102. For example, the drive assembly housing 102 may include an opening, and the sleeve 104 may be fixed to the drive assembly housing 102 in or near such an opening. The sleeve 104 may extend from the drive assembly housing 102 and may be configured to receive and fix a fluid reservoir 106 therein. The example illustrated in Figure 1 shows one fluid reservoir 106, but other embodiments of the fluid injector 100 may include two (or more) fluid reservoirs 106 and a corresponding number of sleeves 104. The fluid reservoir 106 may define an internal reservoir volume including a plunger 108. At least a portion of the drive assembly may be housed within the drive assembly housing 102. The drive assembly may be configured to pressurize the fluid in the internal reservoir volume. For example, a drive assembly can be connected to a plunger 108 at an opening in the drive assembly housing 102, and can drive the plunger 108 within the internal reservoir volume of the fluid reservoir 106. As the plunger 108 is driven to advance within the fluid reservoir 106, the fluid within the internal reservoir volume can be pressurized and output along a fluid line 109 leading from the fluid reservoir 106 to the patient. In one application of the fluid injector 100, the output fluid, such as a contrast agent, can be pressurized in the range of 1000 to 1500 psi (e.g., 1200 psi). In embodiments including two (or more) fluid reservoirs 106, a corresponding number of drive assemblies can be housed within the drive assembly housing 102 to pressurize the fluid in each fluid reservoir.

[0015] The illustrated embodiment of the fluid injector 100 includes several features that may be useful for pressurizing and delivering fluid during operation. For example, the fluid injector 100 may include a control panel 110. The control panel 110 can provide a user interface for various operating modes. For example, the control panel 110 may be used by an operator to set various parameters and / or protocols used for a given fluid infusion procedure. The control panel 110 may also be used to initialize the fluid injector 100 (e.g., to prepare it for fluid infusion for a patient) or to initiate certain features or sequences of operations. In some cases, as shown herein, a hand controller 113 may be connected to the control panel 110 and used by an operator to remotely input infusion-related commands to the fluid injector 100. The control panel 110 may also provide status information, including information related to past or currently ongoing infusion procedures and any appropriate warnings. The control panel 110 may include an image engine having one or more processors to control the operation of the powered fluid injector 100. Such a processor may also communicate with and / or control other components, such as any sensors and detectors (e.g., an air sensing sensor 126 and / or a hemodynamic pressure transducer 128) connected to the drive assembly, the peristaltic pump 112 if present, and / or the fluid injector 100.

[0016] The fluid injector 100 may also include one or more components useful for supplying the fluids used in the injection procedure. In applications where two fluids are injected into a patient, fluid supply containers 114 and 118 may be fluidically connected to the fluid injector 100. For example, fluid supply container 114 may be a contrast fluid supply container, and fluid supply container 118 may be a saline solution fluid supply container. As shown herein, a holder 116 may be included in the fluid injector 100 to hold the fluid supply container 114, and a holder 120 may be included in the fluid injector 100 to hold the fluid supply container 118. In the illustrated embodiment, the fluid from the fluid supply container 114 (e.g., contrast fluid) may be supplied to the fluid reservoir 106 for use during the injection procedure. For example, when the plunger 108 is retracted (e.g., moved toward the drive assembly housing 102) thereby refilling the internal reservoir volume, the fluid from the fluid supply container 114 may be drawn into the fluid reservoir 106. In the illustrated embodiment, the fluid injector 100 includes a peristaltic pump 112 for delivering fluid from a fluid supply container 118 to the patient. Often, the peristaltic pump 112 may be used to deliver non-contrast fluids, such as saline solutions, at a pressure lower than the pressure at which the drive assembly delivers contrast fluid from the reservoir 106. However, as noted above, in other embodiments, the fluid injector 100 may include a second fluid reservoir 106, and a corresponding drive assembly housed in a drive assembly housing 102 may be used to pressurize and deliver non-contrast fluid from the fluid supply container 118. In some such embodiments, the second fluid reservoir 106 and the corresponding drive assembly may be present instead of the peristaltic pump 112.

[0017] The manifold connector 124 may be included to selectively route one of the fluid reservoir 106 and the peristaltic pump 112 (or a second fluid reservoir 106, depending on the embodiment) to communicate with the patient. Thus, the manifold connector 124 can selectively route fluid from the fluid supply container 114 and fluid from the fluid supply container 118 to communicate with the patient. For example, in response to a change in pressure, the manifold connector 124 can switch the flow of fluid to the patient from one of the fluid reservoir 106 and the fluid supply container 114 to the other of the peristaltic pump 112 (or a second fluid reservoir 106, depending on the embodiment) and the fluid supply container 118. The patient interface connector 127 may also be included, for example in a fluid line 109, to selectively allow fluid, such as fluid from the manifold connector 124, to pass through, for example, to a patient interface component (e.g., a catheter such as an infusion catheter). The patient interface connector 127 may include a valve configured to selectively allow fluid to communicate through the patient interface connector 127.

[0018] As described above, one or more sensors may be connected to the fluid injector 100 to provide information related to the infusion. In the illustrated embodiment, an air detection sensor 126 and a hemodynamic pressure transducer 128 are connected to the fluid injector 100. The air detection sensor 126 may be configured to detect the presence of air (e.g., one or more bubbles) in one or more components. As shown herein, the air detection sensor 126 may be configured to detect the presence of air in the fluid line 109 at a location between the outlet of the manifold connector 124 and the patient. For example, the fluid line 109 may have an air detection interface where the air detection sensor 126 can detect the presence of air in the fluid line 109. When such air is detected, the air detection sensor 126 may output a signal to the fluid injector 100, and the fluid injector 100 may take a corresponding action, such as stopping the infusion and / or providing a warning to the user. The hemodynamic pressure transducer 128 may be configured to measure the pressure in the fluid line 109, for example. When the manifold connector 124 is open to allow the hemodynamic pressure transducer 128 to fluidly communicate with the patient, the hemodynamic pressure transducer 128 can output a signal corresponding to the pressure inside the patient.

[0019] Preparing a fluid injector for use can involve many steps. Since some components used in fluid infusion are replaced routinely (e.g., after each use), preparing a fluid injector for use may involve frequently replacing and properly connecting new components. When these new components are connected, the preparation of the fluid injector may also include an air purging process (e.g., before introducing fluid from the injector 100 into the patient). The air purging process removes any air contained in the infusion components, so that no air is introduced into the patient during infusion. These steps can be time-consuming and require meticulous attention. However, some fluid injector applications may be time-sensitive, and paying attention to the details required to properly prepare the fluid injector for such applications can be difficult in real time.

[0020] The present disclosure describes embodiments that can facilitate a more efficient workflow when preparing a fluid injector for use. The embodiments disclosed herein can, for example, allow a component to be set on a fluid injector while maintaining the sterility of other components, prior to an application where the fluid injector is required. More specifically, the embodiments can allow various components to be connected to the fluid injector and can facilitate an air purge process, prior to an application where the fluid injector is required. At the same time, the packaging container can maintain a sterile environment around other components while the necessary connections are made and the air purge process is performed. Thus, when the need to use the fluid injector arises later, removal of the packaging container and connection to a patient component (e.g., an infusion catheter) can be the only preparation required at that time to use the fluid injector. Accordingly, embodiments within the scope of the present disclosure can reduce the time required to prepare for fluid infusion. This can be particularly useful in time-sensitive infusion applications.

[0021] In summary, FIGS. 2 - 4 show an exemplary sequence, including the setting of an infusion set kit and a corresponding infusion system. This exemplary sequence begins with the infusion set kit provided first in FIG. 2. Next, in FIG. 3, the setting of the components removed from one packaging container proceeds while another packaging container remains closed. Next, in FIG. 4, the infusion system is set and made ready for use.

[0022] Figure 2 shows a schematic diagram of one embodiment of the injection setting kit 200. The injection setting kit 200 shown in Figure 2 includes embodiments of a first packaging container 205 and embodiments of a second packaging container 210. Each of the first packaging container 205 and the second packaging container 210 may enclose one or more components. The second packaging container 210 may be a different packaging container from the first packaging container 205. If the packaging containers 205 and 210 are different packaging containers, opening one of the first packaging container 205 and the second packaging container 210 may allow the one or more components enclosed by them to be removed while retaining the one or more components enclosed by the other of the first packaging container 205 and the second packaging container 210. In this way, the injection setting kit 200 may allow a component to be set up in a fluid injection system while maintaining a sterile environment around the other components that remain enclosed in the unopened packaging container. Thus, the injection setting kit 200 may be configured to allow one of the packaging containers, such as the second packaging container 210, to be opened and its components removed, while maintaining a sterile environment in the other packaging container, such as the first packaging container 205.

[0023] The first packaging container 205 may define a first closed internal volume 212. The first packaging container 205 may surround the first closed internal volume 212. In some embodiments, the first packaging container 205 surrounds the first closed internal volume 212 such that one or more components within the first closed internal volume 212 cannot be removed until the first packaging container 205 is opened. In one embodiment, the first closed internal volume 212 may no longer be considered "closed" when an action is taken to open the first packaging container 205 and thus physically change its configuration. For example, the first packaging container 205 may be sealed around the first closed internal volume 212 to surround the first closed internal volume 212. This may include the first packaging container 205 being sealed around any component that extends outside the first closed internal volume 212. In various embodiments, the first packaging container 205 may surround the first closed internal volume 212 such that the first closed internal volume 212 defines a sterile environment.

[0024] Similarly, the second packaging container 210 may define a second closed internal volume 214. The second packaging container 210 may surround the second closed internal volume 214. In some embodiments, the second packaging container 210 surrounds the second closed internal volume 214 such that one or more components within the second closed internal volume 214 cannot be removed until the second packaging container 210 is opened. In one embodiment, the second closed internal volume 214 may no longer be considered "closed" when an action is taken to open the second packaging container 210 and thus physically change its configuration. For example, the second packaging container 210 may be sealed around the second closed internal volume 214 to surround the second closed internal volume 214. This may include the second packaging container 210 being sealed around any component that extends outside the second closed internal volume 214. In various embodiments, the second packaging container 210 may surround the second closed internal volume 214 such that the second closed internal volume 214 defines a sterile environment.

[0025] Depending on the specific embodiment, any number of different components may be included within the first closed internal volume 212 and the second closed internal volume 214. Exemplary embodiments of the infusion setup kit 200 described herein include components within the first closed internal volume 212 and the second closed internal volume 214 that are suitable for facilitating a more efficient workflow when preparing a fluid injector for use. Specifically, the illustrated infusion setup kit 200 may allow certain components to be set up in the fluid injector before an application requiring the fluid injector, while maintaining the sterility of other components that will be used later during the fluid infusion operation associated with the patient procedure.

[0026] As shown in the embodiment of Figure 2, a patient interface connector 127 is contained within the first closed internal volume 212 of the first packaging container 205. The patient interface connector 127 may include a patient interface inlet 256, a first patient interface outlet 257, and a valve 259. The valve 259 may be configured to selectively allow fluid to be communicated through the patient interface connector 127 from the patient interface inlet 256 to the first patient interface outlet 257. As shown in Figure 2, the patient interface connector 127 may be fluidically connected to a manifold connector 124 while enclosed within the first closed internal volume 212. Specifically, the patient interface inlet 256 may be fluidically connected to the manifold outlet 220 of the manifold connector 124 by a fluid line 109. Thus, within the first closed internal volume 212, the patient interface inlet 256 may be fluidically connected to the manifold outlet 220.

[0027] In some cases, as shown herein, the patient interface connector 127 may further include a second patient interface outlet 258. In some examples, the second patient interface outlet 258 may serve as a lavage outlet. For example, the second patient interface outlet 258 may provide an outlet for removing unwanted material from the fluid line 109, such as bubbles or fluid remaining there from a previous operation (e.g., for removing residual contrast fluid remaining in line 109 before supplying lavage fluid through line 109). If a second patient interface outlet 258 is included, the valve 259 may be configured to selectively allow fluid to be communicated through the patient interface connector 127 from the patient interface inlet 256 to either the first patient interface outlet 257 or the second patient interface outlet 258. For example, after the first packaging container 205 is opened, the valve 259 may be manually operated by the user to position one of the first patient interface outlets 257 and the second patient interface outlet 258 to be in fluid communication with the patient interface inlet 256, while preventing fluid communication between the first patient interface outlet 257 and the second patient interface outlet 258 and the other.

[0028] In some embodiments, the first closed internal volume 212 of the first packaging container 205 may further include a fluid recovery container 250. The fluid recovery container 250 may be configured to receive and hold fluid. Within the first closed internal volume 212, the first patient interface outlet 257 may be fluidically connected to the fluid recovery container 250. Specifically, as shown in the illustrated embodiment of Figure 2, the first patient interface outlet 257 may be fluidically connected to the fluid recovery container 250 such that the fluid recovery container 250 is in fluid communication with the manifold outlet 220 via the fluid line 109 and the patient interface connector 127. Thus, the fluid recovery container 250 may be configured to receive and hold fluid output from the manifold outlet 220. As further described herein, the fluid recovery container 250 may be used to recover fluid before injecting it into the patient. For example, the fluid recovery container 250 may be used to recover fluid during the setup of the fluid injection system, such as during an air purging process.

[0029] Furthermore, the first fluid line end 227 may be contained within the first closed internal volume 212 of the first packaging container 205. The infusion setup kit 200 may include a fluid line 109 having a first fluid line end 227 and a second fluid line end 229. The first fluid line end 227 may be connected to a patient interface inlet 256 within the first closed internal volume 212 of the first packaging container 205. The second fluid line end 229 may extend outside the first closed internal volume 212 of the first packaging container 205. Thus, in this configuration, before opening the first packaging container 205, a portion of the fluid line 109 may be within the first closed internal volume 212, while another portion of the fluid line 109 may be outside the first closed internal volume 212.

[0030] Included within the second closed internal volume 214 of the second packaging container 210 is a manifold connector 124, as shown in the embodiment of Figure 2. The manifold connector 124 may include a first manifold inlet 216, a second manifold inlet 218, and a manifold outlet 220. The manifold connector 124 may be configured to selectively position one of the first manifold inlet 216 and the second manifold inlet 218 to be in fluid communication with the manifold outlet 220.

[0031] In one embodiment, to facilitate this selective fluid communication, the manifold connector 124 may include a manifold valve 222. The manifold valve 222 may be configured to move between one position that blocks a first manifold inlet 216 and another position that blocks a second manifold inlet 218. For example, the manifold valve 222 may be configured to move between such positions in response to a change in fluid pressure at the manifold connector 124. Thus, the manifold valve 222 may be configured to move in response to a change in pressure at the manifold connector 124 between a first manifold valve position (e.g., shown in Figure 2) in which the manifold valve 222 blocks fluid communication from the first manifold inlet 216 to the manifold outlet 220 and a second manifold valve position (e.g., shown in Figure 4) in which the manifold valve 222 blocks fluid communication from the second manifold inlet 218 to the manifold outlet 220. In some embodiments, the manifold valve 222 can be biased to a first manifold valve position (for example, via a biasing member such as a spring). Then, when the pressure at the first manifold inlet 216 reaches a predetermined threshold, the biasing force at the manifold valve 222 can be overcome, moving the manifold valve 222 to a second manifold valve position.

[0032] In some embodiments, the second closed internal volume 214 of the second packaging container 210 may further include an air detection interface 239. The air detection interface 239 may be configured to facilitate the detection of the presence of air in the fluid line 109. For example, the air detection interface 239 may be configured to interface with an air detection sensor 126, and the air detection sensor 126 may be configured to detect the presence of air in the fluid line 109. The air detection sensor 126 may thus be able to detect the presence of air (e.g., one or more bubbles) in the fluid line 109 at the air detection interface 239 and output a signal when air is detected. The air detection interface 239 may be located downstream of the manifold outlet 220, as shown in Figure 2. Specifically, in the illustrated embodiments, the air detection interface 239 is included in the fluid line 109. In one example, the air detection interface 239 may be a region of the fluid line 109. In such an example, the air detection interface 239 may be a region of the fluid line 109 that is downstream of the manifold outlet 220 and also within the second closed internal volume 214.

[0033] In one embodiment, as shown in Figure 2, the second closed internal volume 214 of the second packaging container 210 may also include a cleaning fluid line 230. The cleaning fluid line 230 may have a first cleaning fluid line end 228 and a second cleaning fluid line end 234. The first cleaning fluid line end 228 may be connected to a second manifold inlet 218 within the second closed internal volume 214 of the second packaging container 210. As shown in the illustrated embodiment, both the first cleaning fluid line end 228 and the second cleaning fluid line end 234 may be located within the second closed internal volume 214. In another embodiment, the second closed internal volume 214 of the second packaging container 210 may additionally include a contrast fluid line connected to the first manifold inlet 216. However, in some embodiments, there may be no fluid lines at all connected to either the first or second manifold inlets 216, 218 within the second closed internal volume 214 of the second packaging container 210.

[0034] Also contained within the second closed internal volume 214 of the second packaging container 210 may be the second fluid line end 229 of the fluid line 109. The second fluid line end 229 may be connected to the manifold outlet 220 of the manifold connector 124. Thus, as shown in Figure 2, the second fluid line end 229 extends outside the first closed internal volume 212 of the first packaging container 205 and connects to the manifold outlet 220 outside the first closed internal volume 212 of the first packaging container 205. Specifically, as shown here, the second fluid line end 229 extends outside the first closed internal volume 212 of the first packaging container 205 and extends into the second closed internal volume 214 of the second packaging container 210 and connects to the manifold outlet 220 inside the second closed internal volume 214 of the second packaging container 210.

[0035] To facilitate the extension of one or more components, such as a portion of a fluid line 109, outside the first closed internal volume 212, the first packaging container 205 may include one or more openings 236a. For example, the first packaging container 205 may define an opening 236a through which at least the second fluid line end 229 of the fluid line 109 extends outside the first closed internal volume 212 of the first packaging container 205. If more than one component extends outside the first closed internal volume 212, the first packaging container 205 may define an opening for each such component extending outside the first closed internal volume 212. Even if more than one component extends outside the first closed internal volume 212, the first packaging container 205 can have a single common opening, such as an opening 236a, through which each component extends outside the first closed internal volume 212.

[0036] The opening 236a may be sized to close (e.g., in a sealed manner) the first closed internal volume 212 by one or more portions extending outside the first closed internal volume 212. For example, the opening 236a may be sized to close the first closed internal volume 212 around the outer surface of the fluid line 109. In this example, the first packaging container 205 may be in contact with the outer surface of the fluid line 109 at the location of the opening 236a. The opening 236a may thus be sized to allow an intended component(s), such as the fluid line 109, to extend outside the first closed internal volume 212, but to prevent other components from extending outside the first closed internal volume 212. For example, the opening 236a may be sized to prevent the patient interface connector 127 from extending outside the first closed internal volume 212.

[0037] In the embodiment shown in Figure 2, one or more components extending outside the first closed internal volume 212 may extend into the second closed internal volume 214 of the second packaging container 210. For example, as shown in Figure 2, a portion of the fluid line 109 extends outside the first closed internal volume 212 and into the second closed internal volume 214. Thus, the end of the second fluid line 229 may extend into the second closed internal volume 214.

[0038] To facilitate the extension of one or more components, such as a portion of the fluid line 109, into the second closed internal volume 214, the second packaging container 210 may include one or more openings 236b. For example, the second packaging container 210 may define an opening 236b through which at least the end of the second fluid line 229 extends into the second closed internal volume 214 of the second packaging container 210. If more than one component extends into the second closed internal volume 214, the second packaging container 210 may define an opening for each such component extending into the second closed internal volume 214. Even if more than one component extends into the second closed internal volume 214, the second packaging container 210 may define a single common opening, such as an opening 236b, through which each component extends into the second closed internal volume 214.

[0039] In one embodiment, the opening 236b (if included) may correspond to the opening 236a (if included). For example, the opening 236b may be one or more components extending into the second closed internal volume 214, and may be sized to close the second closed internal volume 214, and the opening 236b may be the same size as the corresponding opening 236a. In the illustrated embodiment, the opening 236b may be sized to close the second closed internal volume 214 around the outer surface of the fluid line 109.

[0040] The injection setting kit 200 shown in Figure 2 includes a first packaging container 205 that interfaces with a second packaging container 210. In this illustrated embodiment, the opening 236a of the first packaging container 205 interfaces with the opening 236b of the second packaging container 210. The opening 236a contained in the first packaging container 205 can be aligned with the opening 236b contained in the second packaging container 210.

[0041] In some embodiments, the first and second packaging containers 205, 210 may be removably connected together. For example, the first and second packaging containers 205, 210 may be removably connected together in a common packaging area that the packaging containers 205, 210 interface with. In the illustrated embodiments, the first packaging container 205 includes a faceplate 260, and the second packaging container 210 includes a faceplate 265. The faceplates 260, 265 may be made of a different material (e.g., a more ridged material) than the material of the packaging containers 205, 210. As shown herein, the faceplate 260 may be positioned over the area of ​​the first packaging container 205 having an opening 236a, and in some cases, it may be the faceplate 260 that defines the opening 236a of the first packaging container 205. The faceplate 265 can be positioned over the region of the second packaging container 210 having an opening 236b, and in some cases, the faceplate 265 may define the opening 236b of the second packaging container 210. The faceplate 265 of the second packaging container 210 may be configured to be removably connected to the faceplate 260 of the first packaging container 205. For example, the faceplate 265 may include a connecting element 270b, which is configured to be removably connected to a corresponding connecting element 270a included in the faceplate 260. The corresponding connecting elements 270a, 270b can be any variety of suitable connecting elements, such as interlocking members (e.g., buttons or other sliding or snap-fit ​​members). In other examples, instead of, or in addition to, separate connecting elements, the faceplates 260, 265 may include adhesive or tear-away connections between them.

[0042] Figure 3 shows an exemplary schematic diagram of the first packaging container 205 as described above, but with the second packaging container removed. As shown in Figure 3, when the second packaging container is opened, the components removed from the second packaging container can be connected to the corresponding components of the injection system.

[0043] When the second packaging container is opened and removed from the injection setup kit, the first packaging container 205 may be configured to continue surrounding the first closed internal volume 212 and the components contained within the first closed internal volume 212. For example, the first packaging container 205 may include a mounting member 206 configured to allow the first packaging container 205 to be removably secured to a fluid injector, such as on a drive assembly housing 102. In one embodiment, the fluid injector may have a corresponding mounting member configured to removably receive the mounting member 206. This may allow the first packaging container to be temporarily placed in a known convenient location while the components removed from the second packaging container are connected to the injector and the injection system is being set up.

[0044] Thus, the second packaging container may be opened and removed from the infusion setup kit without opening the first packaging container 205. This may be the case when the first and second packaging containers are separate containers. When the first and second packaging containers interface and are detachably connected together, the detachable connection between them (e.g., via a faceplate) may be configured to allow the second packaging container to be removed without opening the first packaging container 205. For example, when the second packaging container is removed from the infusion setup kit, the first packaging container 205 may be configured to maintain a sterile environment within its first closed internal volume 212. In addition, as shown herein, when the second packaging container is removed from the infusion setup kit, the first packaging container 205 may be configured to maintain the first fluid line end 227, connected to the patient interface inlet 256, within the first closed internal volume 212 of the first packaging container 205.

[0045] The second packaging container can be opened, and one or more components contained within the second packaging container can be removed and connected to one or more corresponding fluid injection system components. For example, the step of opening the second packaging container may include the step of introducing the internal volume defined by the second packaging container into the ambient environment, so as to no longer define a second closed internal volume when the second packaging container is opened. At the same time, the steps of opening and removing the second packaging container may include the step of maintaining the closed internal volume 212 of the first packaging container 205 and the sterile environment within the closed internal volume 212.

[0046] In the illustrated embodiment, the step of opening the second packaging container may include the step of removing the manifold connector 124 from the second packaging container. When the manifold connector 124 is removed from the second packaging container, it can be connected to the second fluid line end 229, while the first fluid line end 227 is located within the first closed internal volume 212 of the first packaging container 205. Thus, the step of removing the manifold connector 124 from the second packaging container may include the step of removing the second fluid line end 229 from the second packaging container. In other embodiments, the second fluid line end 229 may be disconnected from the manifold connector 124 while remaining enclosed within the second packaging container, and the user may connect the second fluid line end 229 to the manifold connector 124 after the second packaging container has been removed. As shown herein, when the manifold connector 124 is removed from the second packaging container, the fluid line 109 can extend through the opening 236a contained in the first packaging container 205, and the first fluid line end 227 can be connected to the patient interface inlet 256 in the first closed internal volume 212.

[0047] After the steps of opening the second packaging container and removing the manifold connector 124, the manifold connector 124 may be connected to a fluid injector, such as being fluidly connected to one or more fluid supply containers 114, 118. Specifically, after the steps of opening the second packaging container and removing the manifold connector 124, the manifold connector 124 may be connected to at least one fluid reservoir 106. In the illustrated embodiment, the manifold connector 124 is fluidly connected to two fluid reservoirs 106. As shown in Figure 3, the first manifold inlet 216 may be fluidly connected to one fluid reservoir 106, and the second manifold inlet 218 may be fluidly connected to another fluid reservoir 106. Specifically, the first manifold inlet 216 may be fluidly connected to one fluid reservoir by a contrast fluid line 226. The contrast fluid line 226 may have a first contrast fluid line end 224 and a second contrast fluid line end 232. The first contrast fluid line end 224 can be connected to a first manifold inlet 216, and the second contrast fluid line end 232 can be connected to a reservoir outlet 284 of the fluid reservoir 106. The second manifold inlet 218 can be fluidically connected to another fluid reservoir 106 by a cleaning fluid line 230. The first cleaning fluid line end 228 can be fluidically connected to the second manifold inlet 218, and the second cleaning fluid line end 234 can be fluidically connected to a reservoir outlet 284 of the other fluid reservoir 106.

[0048] As described above, in some embodiments the second packaging container may include a cleaning fluid line 230. In these embodiments, the step of opening the second packaging container may include the step of removing the cleaning fluid line 230 from the second packaging container. In these embodiments, the first cleaning fluid line end 228 is fluidically connected to the second manifold inlet 218 before the step of opening the second packaging container. Thus, in these embodiments, the step of connecting the second manifold inlet 218 to the fluid injector may only include the step of fluidically connecting the second cleaning fluid line end 234 to the reservoir outlet 284 of another fluid reservoir 106.

[0049] In addition, in the illustrated embodiment, the step of opening the second packaging container may include the step of removing the air detection interface 239 from the second packaging container. For example, if the air detection interface 239 is in the region of the fluid line 109, as in the illustrated embodiment, the air detection interface 239 may be removed from the second packaging container when the portion of the fluid line 109 is removed from the second packaging container. As shown in Figure 3, when the air detection interface 239 is removed from the second packaging container, the air detection interface 239 may be positioned to interface with the air detection sensor 126, so that the presence of air in the fluid line 109 can be detected.

[0050] As shown in Figure 3, when one or more components removed from the second packaging container are connected to the corresponding components of the infusion system, further actions may be taken to prepare the infusion system for subsequent use in a patient. Such further actions may be taken while some components remain enclosed within the first closed internal volume 212 of the first packaging container 205. For example, when one or more components removed from the second packaging container are connected to components of the infusion system in order to prepare the infusion system for subsequent use in a patient, while some components remain enclosed within the first closed internal volume 212, one or more air purging actions may be taken.

[0051] As shown in Figure 3, after the step of connecting the manifold connector 124 to the fluid injector, the fluid can be transmitted through the manifold connector 124, the fluid line 109, and the patient interface connector 127.

[0052] For example, after the step of connecting the first manifold inlet 216 to the contrast fluid supply container 114, the contrast fluid may be delivered from the contrast fluid supply container 114 along the contrast fluid line 226 and to the fluid recovery container 250 located in the closed internal volume 212 of the first packaging container 205. This may also include the step of transmitting the contrast fluid through the manifold connector 124, the fluid line 109, and the patient interface connector 127, where the first fluid line end 227 and the patient interface connector 127 are fluidically connected within the closed internal volume 212. For example, the manifold valve 222 may be positioned to block the second manifold inlet 218, and the contrast fluid may be transmitted from the manifold outlet 220 through the first manifold inlet 216. Alternatively, the valve 259 may be positioned to allow the fluid to be communicated from the patient interface inlet 256 to the first patient interface outlet 257 and then into the fluid recovery container 250. In the illustrated embodiment, the contrast fluid supply container 114 is fluidly connected to the fluid reservoir 106 via a contrast fluid supply line 285, which has a first contrast fluid supply line end 286 fluidly connected to the reservoir inlet 283 and a second contrast fluid supply line end 287 fluidly connected to the contrast fluid supply container 114. The step of transferring the contrast fluid along the contrast fluid line 226 to the fluid recovery container 250 may act to purge air from components connected on the contrast fluid path, including components located in a closed internal volume 212.

[0053] In addition, after the step of connecting the second manifold inlet 218 to the cleaning fluid supply container 118, the cleaning fluid may be delivered from the cleaning fluid supply container 118 along the cleaning fluid line 230 and to the fluid recovery container 250 located in the closed internal volume 212 of the first packaging container 205. This may also include the step of transmitting the cleaning fluid through the manifold connector 124, the fluid line 109, and the patient interface connector 127, where the first fluid line end 227 and the patient interface connector 127 are fluidically connected within the closed internal volume 212. For example, the manifold valve 222 may be positioned to block the first manifold inlet 216, and the cleaning fluid may be transmitted from the manifold outlet 220 through the second manifold inlet 218. The valve 259 may also be positioned to allow the fluid to be communicated from the patient interface inlet 256 to the first patient interface outlet 257 and then into the fluid recovery container 250. In the illustrated embodiment, the cleaning fluid supply container 118 is fluidically connected to the fluid reservoir 106 via a cleaning fluid supply line 293, which has a first cleaning fluid supply line end 294 fluidly connected to the reservoir inlet 283 and a second cleaning fluid supply line end 295 fluidly connected to the cleaning fluid supply container 118. The step of transferring the cleaning fluid along the cleaning fluid line 230 to the fluid recovery container 250 may act to purge air from components connected on the cleaning fluid path, including components located in a closed internal volume 212.

[0054] The ability to connect various components and purge air from these components may allow the fluid infusion system to be set up before subsequent use in a patient. This pre-setup may help reduce the time and effort required to prepare the fluid infusion system when needed. Furthermore, the embodiments described herein may maintain certain patient interface components of the infusion system in a sterile environment, such as within the first packaging container 205, while this pre-setup is being performed. Thus, when the infusion system needs to be used in a patient, the time and effort required for setup are significantly reduced. This may allow for faster coordination with the infusion system and less burden on the user during setup, enabling various diagnostic procedures to be performed. This may help improve the outcomes of such diagnostic procedures.

[0055] If an infusion becomes necessary, the first packaging container may be removed and an infusion catheter may be connected. Embodiments disclosed herein may allow various setup steps to be performed in advance so that these setup steps may not need to be performed when an infusion becomes necessary. For example, in one embodiment, the only required step may be the step of removing the first packaging container. In another embodiment, the only required steps may be the step of removing the first packaging container and the step of connecting the infusion catheter. In a further embodiment, the only required steps may be the step of removing the first packaging container, the step of removing the fluid recovery container, and the step of connecting the infusion catheter.

[0056] Figure 4 shows an exemplary schematic diagram illustrating the state in which both the first and second packaging containers have been removed. As shown in Figure 4, one or more components removed from the second packaging container may be connected to the corresponding components of the infusion system, as described with reference to Figure 3. And as also shown in Figure 4, one or more components removed from the first packaging container may be connected to the infusion catheter. For example, the first packaging container may be opened both after the second packaging container has been opened and after one or more components that were previously in the second packaging container have been connected to the components of the infusion system. In some cases, contrast and / or washing fluid may be delivered through one or more components that were previously in the second packaging container and connected to the components of the infusion system before the step of opening the first packaging container (e.g., as part of an air purging step).

[0057] For example, in the illustrated embodiment, the first packaging container may be opened after the step of delivering the contrast fluid to the fluid recovery container. The step of opening the first packaging container may include the step of removing the patient interface connector 127 from the first packaging container. Since the patient interface connector 127 is connected to the first fluid line end 227, the step of removing the patient interface connector 127 from the first packaging container may include the step of removing the first fluid line end 227 from the first packaging container. In addition, the step of opening the first packaging container may include the step of removing the fluid recovery container from the first packaging container.

[0058] As shown in Figure 4, once the first packaging container is opened, the infusion catheter 290 may be fluidically connected to one or more components that were previously surrounded within the first packaging container. For example, in the illustrated embodiment, after the step of opening the first packaging container, the patient interface connector 127 may be fluidically connected to the infusion catheter 290. In this example, this allows the fluid reservoir 106 and each of the associated fluid supply containers 114, 118 to be arranged to fluidly communicate with the infusion catheter 290. In an embodiment in which a fluid recovery container is included within the first packaging container to hold fluid received before the step of opening the first packaging container, for example, the fluid recovery container may be removed after the step of opening the first packaging container. For example, the fluid recovery container may be removed from the first patient interface outlet 257, and the infusion catheter 290 may be connected at the first patient interface outlet 257. Once disconnected, the fluid recovery container may be discarded.

[0059] The infusion catheter 290 may be configured to be placed in or within the patient and to deliver fluid to the patient. After the step of fluidically connecting the infusion catheter 290 to a patient interface connector 127 or the like, one or more fluids may be delivered from the fluid injector to the infusion catheter 290. For example, contrast fluid may be delivered from the fluid reservoir 106 through the manifold connector 124 and along the fluid line 109 to the infusion catheter 290. As another example, lavage fluid may be delivered from another fluid reservoir 106 through the manifold connector 124 and along the fluid line 109 to the infusion catheter 290.

[0060] In the example shown herein, the infusion catheter 290 includes a fluid delivery port 291. The fluid delivery port 291 may be configured to deliver fluid received by the infusion catheter 290 from one or more components shown in Figure 4 to the patient (e.g., in a region of interest within the patient).

[0061] In the example shown herein, the infusion catheter 290 also includes an imaging element 292. The imaging element 292 may be configured to collect image data and transmit the image data to an image engine for processing and / or display. In some cases, the introduction of fluid through the infusion catheter 290 may improve the quality of the image data collected by the imaging element 292.

[0062] Figure 5 is a schematic diagram showing another embodiment of the injection setting kit 300. The injection setting kit 300 is similar to the injection setting kit 200, except that additional components are contained within the second closed internal volume 214 of the second packaging container 210. Thus, the reference letters shown in Figure 5 for the injection setting kit 300 are used to indicate the presence of elements similar to those previously described with respect to the injection setting kit 200.

[0063] The components contained within the first closed internal volume 212 of the first packaging container 205 in the infusion setting kit 300 are the same as those previously described for the infusion setting kit 200. That is, the first closed internal volume 212 of the first packaging container 205 in the infusion setting kit 300 includes a patient interface connector 127, a first fluid line end 227, and a fluid recovery container 250. The patient interface connector 127 is fluidically connected to both the fluid recovery container 250 and the first fluid line end 227 within the first closed internal volume 212.

[0064] The second closed internal volume 214 of the second packaging container 210 in the injection setup kit 300 includes the manifold connector 124. As shown in Figure 5, the second closed internal volume 214 of the second packaging container 210 in the injection setup kit 300 also includes the contrast fluid line 226, the wash fluid line 230, the first fluid reservoir 106a, and the second fluid reservoir 106b. Each of the first fluid reservoir 106a and the second fluid reservoir 106b defines an internal reservoir volume 281. The internal reservoir volume 281 of each of the first fluid reservoir 106a and the second fluid reservoir 106b may include the plunger 108. Each of the first fluid reservoir 106a and the second fluid reservoir 106b may also include a reservoir outlet 284 (and, in some embodiments, a reservoir inlet 283 as previously shown).

[0065] The contrast fluid line 226 has a first contrast fluid line end 224 and a second contrast fluid line end 232. The first contrast fluid line end 224 is connected to a first manifold inlet 216 in a second closed internal volume 214 of the second packaging container 210. The second contrast fluid line end 232 is connected to a first fluid reservoir 106a in a second closed internal volume 214 of the second packaging container 210.

[0066] The cleaning fluid line 230 has a first cleaning fluid line end 228 and a second cleaning fluid line end 234. The first cleaning fluid line end 228 is connected to a second manifold inlet 218 in a second closed internal volume 214 of the second packaging container 210. The second cleaning fluid line end 234 is connected to a second fluid reservoir 106b in a second closed internal volume 214 of the second packaging container 210.

[0067] When the second packaging container 210 is opened, the fluid reservoirs 106a, 106b, the contrast fluid line 226, the irrigation fluid line 230, the manifold connector 124, and the second fluid line end 229 can all be removed from the second closed internal volume 214 while fluidly connected. When these components are removed from the second closed internal volume 214, the manifold connector 124 can be fluidly connected to the patient interface connector 127 via the fluid line 109. The fluid reservoirs 106a, 106b can be secured in their respective sleeves 104 contained within the drive assembly housing 102 of the fluid injector. The step of securing the fluid reservoirs 106a, 106b in their respective sleeves 104 may include connecting the respective plungers 108 to the drive assembly of the fluid injector so that the drive assembly can move the plungers 108 within their respective internal reservoir volumes 281. The fluid purging process can then be carried out in the manner described with respect to the injection setting kit 200.

[0068] By including at least one fluid reservoir 106a, 106b within the second closed internal volume 214 of the second packaging container 210, the infusion setup kit 300 shown in Figure 5 can further facilitate the efficient setup and initialization (e.g., air purging) of the fluid infusion system before its use in patient procedures. At the same time, the infusion setup kit 300 can maintain a sterile environment for certain components (e.g., components within the first closed internal volume 212 of the first packaging container 205) until it is time to use the fluid infusion system in patient procedures.

[0069] Figures 2–5 illustrate embodiments having a first and a second packaging container, while other embodiments within the scope of this disclosure may include more than two packaging containers. For example, some embodiments may include a third packaging container in addition to the first and second packaging containers. The third packaging container may define a third closed internal volume containing at least one component. In such embodiments, any one or more components disclosed herein may be present in the third packaging container instead of the first and / or second packaging containers. Each of the first, second, and third packaging containers may define a closed internal volume containing at least one component disclosed herein.

[0070] In an exemplary embodiment including first, second, and third packaging containers, the third closed internal volume of the third packaging container may include a fluid recovery container. In this same exemplary embodiment, each of the first closed internal volume of the first packaging container and the second closed internal volume of the second packaging container may include one or more components as previously disclosed herein. For example, the third closed internal volume of the third packaging container may include a fluid recovery container, and the first patient interface outlet may be connected to the fluid recovery container in the third closed internal volume. In this example, the patient interface inlet may be included in the first closed internal volume.

[0071] Figure 6 is a schematic diagram showing another embodiment of the injection setting kit 400. The injection setting kit 400 is similar to the injection setting kit 200, except that the components contained within the first closed internal volume 212 of the first packaging container 205 and / or the second closed internal volume 214 of the second packaging container 210 may differ. Thus, the reference letters shown in Figure 6 for the injection setting kit 400 are used to indicate the presence of elements similar to those previously described with respect to the injection setting kit 200. Components shown by dashed lines in Figure 6 are components that may be optionally included in the injection setting kit 400 depending on the specific application in which the injection setting kit 400 is used.

[0072] The components contained within the first closed internal volume 212 of the first packaging container 205 of the infusion setting kit 400 are the first fluid line end 227 of the fluid line 109, the patient interface connector 127, and the fluid recovery container 250. The patient interface connector 127 is fluidically connected to both the fluid recovery container 250 and the first fluid line end 227 within the first closed internal volume 212.

[0073] Depending on the application in which the injection setting kit 400 is used, the first closed internal volume 212 of the first packaging container 205 of the injection setting kit 400 may contain one or more other components. For example, as shown in Figure 6, one or more (e.g., each) of the valve 405, the pressure measuring device 410, and the first fluid line end 420 of the fluid line 415 may be contained within the first closed internal volume 212 of the first packaging container 205 of the injection setting kit 400. In one embodiment, the valve 405 may be a check valve that allows fluid flow toward the fluid recovery container 250 but restricts (e.g., prevents) fluid flow toward the second fluid line end 229. As shown here, the valve 405 may be located in the fluid line 109, but in other embodiments, the valve 405 may be located in another component within the first closed internal volume 212. In one embodiment, the pressure measuring device 410 may be a pressure transducer configured to measure the fluid pressure in the fluid line 109, and may be connected to, for example, the first fluid line 109. In one embodiment, the first fluid line end 420 of the fluid line 415 may be contained within the first closed internal volume 212. This first fluid line end 420 may be connected to components within the first closed internal volume 212, depending on the application. As shown herein, the fluid line 415 may extend into the first closed internal volume 212 through an opening 236a into which the fluid line 109 extends. However, in another embodiment, a second opening for the fluid line 415 to extend further into the first closed internal volume 212 may be contained within the first packaging container 205.

[0074] The components contained within the second closed internal volume 214 of the second packaging container 210 of the injection setting kit 400 are the second fluid line end 229 of the fluid line 109 and the air detection interface 239.

[0075] Depending on the application in which the injection setting kit 400 is used, the second closed internal volume 214 of the second packaging container 210 of the injection setting kit 400 may contain one or more other components. For example, as shown in Figure 6, one or more (e.g., each) of the valve 425, pressure measuring device 430, manifold connector 124, fluid reservoir 106, and second fluid line end 421 of the fluid line 415 may be contained within the second closed internal volume 214 of the second packaging container 210 of the injection setting kit 400.

[0076] In one embodiment, valve 425 may be a check valve that allows fluid flow toward the patient interface connector 127 but restricts (e.g., prevents) fluid flow toward the second fluid line end 229. As shown herein, valve 425 may be located in the fluid line 109, but in other embodiments, valve 425 may be located in another component within the second closed internal volume 214. In one example, only valve 405 or valve 425 may be included in kit 400, but in another example, both valve 405 and valve 425 may be included in kit 400.

[0077] In one embodiment, the pressure measuring device 430 may be a pressure transducer configured to measure the fluid pressure in the fluid line 109, and may be connected to, for example, the first fluid line 109. In one example, only the pressure measuring device 410 or only the pressure measuring device 430 may be included in the kit 400, but in another example, both the measuring devices 410 and 430 may be included in the kit 400.

[0078] In one embodiment, the manifold connector 124 and / or the fluid reservoir 106 may be contained within the second closed internal volume 214. If the manifold connector 124 is contained, the second fluid line end 229 of the fluid line 109 may be fluidically connected to the manifold connector 124 within the second closed internal volume 214 (for example, at the manifold outlet 220). For example, the second fluid line end 229 may include a Luer connector configured to fluidly connect to a complementary Luer connector at the manifold connector 124 (for example, at the manifold outlet 220). If the fluid reservoir 106 is contained in addition to the manifold connector 124, the reservoir 106 may be fluidically connected to the manifold connector 124 within the second closed internal volume 214 via a contrast-enhancing fluid line 226, which is also contained within the second closed internal volume 214.

[0079] In one embodiment, the second fluid line end 421 of the fluid line 415 may be contained within the second closed internal volume 214. The second fluid line end 421 may be connected to a component within the second closed internal volume 214, depending on the application. As shown herein, the fluid line 415 may extend into the second closed internal volume 214 through an opening 236b into which the fluid line 109 extends. However, in another embodiment, a second opening for the fluid line 415 to extend further into the second closed internal volume 214 may be contained within the second packaging container 210.

[0080] As previously described herein, when the second packaging container 210 is opened, two or more components contained within the second packaging container may be removed from the second closed internal volume 214 while fluidly connected. For example, when these components are removed from the second closed internal volume 214, the manifold connector 124 may be in fluid communication with the patient interface connector 127 via the fluid line 109. As another example, the fluid reservoir 106 may be secured by a sleeve included in the drive assembly housing of the fluid injector. The fluid purging process may then be carried out in the manner described with respect to the infusion setting kit 200.

[0081] Exemplary application embodiments of fluid injectors have been described. However, various other applications are within the scope of this disclosure.

[0082] For example, other embodiments may include applications relating to other medical components. One medical component setting kit may include a first packaging container and a second packaging container. In this embodiment, the first packaging container may define a first closed internal volume containing one or more first-stage medical components, and the second packaging container may define a second closed internal volume containing one or more second-stage medical components. This embodiment may also include a connection line having a first connection line end and a second connection line end. The first connection line end may be connected to one or more of the one or more first-stage medical components within the first closed internal volume of the first packaging container. The second connection line end may extend outside the first closed internal volume of the first packaging container. In one example, the second connection line end may be within the second closed internal volume of the second packaging container. For example, in this example, the second connection line end may be connected to one or more of the one or more second-stage medical components within the second closed internal volume of the second packaging container. In this embodiment of the medical component setting kit, the first and second packaging containers may each define one or more openings and / or include a faceplate as described above.

[0083] In embodiments of the medical component setting kit, one or more first-stage medical components and one or more second-stage medical components may be components configured to be used in the same medical procedure. One or more first-stage medical components may be components configured to be set in place and used in the first stage of the medical procedure, while one or more second-stage medical components may be components configured to remain in a second closed internal volume during the first stage of the medical procedure. For example, the first packaging container can be opened, and at least one of the one or more first-stage medical components may be appropriately positioned outside the internal volume of the first packaging container, while the second connection line end remains connected to one or more second-stage medical components in the second closed internal volume. Next, actions relating to the medical procedure may be performed, such as pre-procedure initialization actions or first steps in the medical procedure. After these actions relating to the medical procedure are performed, the second packaging container can then be opened, and at least one of the one or more second-stage medical components may be appropriately positioned outside the internal volume of the second packaging container. Next, another action relating to the medical procedure, such as the first step, the second step, or any subsequent step, may be performed, for example, by utilizing at least one of the second-stage medical components.

[0084] In a specific example, the embodiment of the medical component setting kit described above may include a fractional flow reserve (FFR) component setting kit. In one exemplary FFR component setting kit, the first closed internal volume of the first packaging container may include one or more of the first end of a guidewire, the first end of a signal wire, and the proximal portion of a sensor delivery device. This exemplary FFR component setting kit may also include a second closed internal volume of a second packaging container having one or more of the second end of a guidewire, the second end of a signal wire, and the distal portion of a sensor delivery device having a pressure sensor. The guidewire, signal wire, and sensor delivery device (for example, if each is included in a specific embodiment) may extend from the first internal volume into the second internal volume. This exemplary FFR component setting kit allows the first packaging container to be opened, and one or more of the first end of the guidewire, the first end of the signal wire, and the proximal portion of the sensor delivery device may be prepared for an FFR procedure by appropriately configuring these components, for example, with respect to a control console. Once one or more of these components are removed and prepared, the second packaging container can be opened, and one or more of the second end of the guidewire, the second end of the signal wire, and the distal portion of the sensor delivery device having a pressure sensor can be inserted into the patient during the FFR procedure.

[0085] Figure 7 shows a flowchart of one embodiment of the injection system setup method 600.

[0086] In step 610, the first packaging container is opened. For example, the first packaging container referred to in this method 600 may be the same as or similar to the second packaging container 210 described elsewhere in this specification. In the step of opening the first packaging container, step 610 may include the step of removing a manifold connector from the first packaging container. The manifold connector removed from the first packaging container may include a first manifold inlet, a second manifold inlet, and a manifold outlet. The manifold outlet of the manifold connector removed from the first packaging container may be connected to one end of a fluid line. The other end of this fluid line may extend into the closed internal volume of the second packaging container. In some embodiments, the second packaging container may surround the closed internal volume, and the second packaging container may include an opening through which the other end of the fluid line extends into the closed internal volume. In many cases, the step of opening the first packaging container in step 610 may include the step of maintaining a sterile environment within the second packaging container. For example, the second packaging container referred to in this method 600 may be the same as or similar to the first packaging container 205 described elsewhere in this specification.

[0087] In a further embodiment, the step of opening the first packaging container in step 610 may also include the step of removing a cleaning fluid line having a first cleaning fluid line end and a second cleaning fluid line end from the first packaging container. The first cleaning fluid line end may be connected to a second manifold inlet. In this further embodiment, after the step of opening the first packaging container, the second cleaning fluid line end may be connected to a cleaning fluid reservoir. After the step of connecting the second cleaning fluid line end to the cleaning fluid reservoir, the cleaning fluid may be delivered along the cleaning fluid line to a fluid recovery container located in the closed internal volume of the second packaging container.

[0088] Following the step of opening the first packaging container, in step 620, the first manifold inlet may be fluidly connected to a contrast fluid reservoir. The contrast fluid reservoir may have an internal reservoir volume including a first plunger.

[0089] After the step of connecting the first manifold inlet to the contrast fluid reservoir, in step 630, the contrast fluid may be delivered from the contrast fluid reservoir along the fluid line to a fluid recovery container located in the closed internal volume of the second packaging container.

[0090] After the step of delivering the contrast fluid to the fluid recovery container, in step 640, the second packaging container may be opened. In the step of opening the second packaging container, step 640 may include removing the other end of the fluid line, the fluid recovery container, and the patient interface connector that is in fluid communication with the fluid line from the second packaging container. The patient interface connector removed from the second packaging container may include a patient interface inlet, a patient interface outlet, and a valve configured to selectively allow fluid to be communicated through the patient interface connector from the patient interface inlet to the patient interface outlet. For example, the patient interface outlet of the patient interface connector may be fluidically connected to the fluid recovery container in the closed internal volume of the second packaging container before the step of opening the second packaging container.

[0091] After the step of opening the second packaging container, in step 650, the patient interface connector may be fluidically connected to the infusion catheter. One or more fluids may be delivered from the connected fluid reservoir to the infusion catheter. For example, after the step of fluidically connecting the patient interface connector to the infusion catheter, contrast fluid may be delivered from the contrast fluid reservoir along the fluid line to the infusion catheter.

[0092] We have described various non-limiting exemplary embodiments. It will be understood that suitable alternatives are possible without departing from the scope of the examples described herein. These examples and other examples are included in the scope of the following claims.

Claims

1. Injection setting kit (200; 300; 400): - Define the first closed, sterile internal volume (212), i. A patient interface connector (127) comprising a patient interface inlet (256), a patient interface outlet (257), and a valve (259) configured to selectively allow fluid to pass through the patient interface connector from the patient interface inlet to the patient interface outlet; and ii. A fluid recovery container (250) fluidically connected to the patient interface outlet; A first packaging container (205) including; - A second packaging container (210) separate from the first packaging container, wherein the second packaging container defines a second closed sterile internal volume (214) including a manifold connector (124) including a manifold inlet (216) and a manifold outlet (220); and, A fluid line (109) having a first fluid line end (227) and a second fluid line end (229), wherein the first fluid line end is fluidly connected to the patient interface inlet within the first closed sterile internal volume of the first packaging container; the second fluid line end extends outside the first closed sterile internal volume of the first packaging container and is fluidly connected to the manifold outlet within the second closed sterile internal volume of the second packaging container; Includes, - The first and second packaging containers are removably connected together in a common packaging area through which the packaging containers interface, and the first and second packaging containers each include openings (236a; 236b) through which the fluid line (109) passes; - When the second packaging container is opened, the first packaging container is configured to maintain i) its first closed sterile internal volume, and ii) the first fluid line end connected to the patient interface connector within the first closed sterile internal volume of the first packaging container; and, - The fluid recovery container is configured to hold the fluid flowing out of the manifold outlet during an air purging process, which is performed when the second packaging container is opened and the first packaging container maintains its first closed, sterile internal volume. Injection setting kit.

2. A kit according to claim 1, The system further comprises a cleaning fluid line (230) having a first cleaning fluid line end (228) and a second cleaning fluid line end (234), and The manifold connector includes a further manifold inlet (218), The first cleaning fluid line end is connected to the further manifold inlet within the second closed sterile internal volume (214) of the second packaging container (210). kit.

3. A kit according to claim 1, The second closed, sterile internal volume (214) of the second packaging container (210) further comprises an air detection interface (239) located downstream of the manifold outlet (220); The air detection interface is configured to facilitate the detection of the presence of air in the fluid line (109); kit.

4. A kit according to claim 1, The second closed sterile internal volume (214) of the second packaging container (210) further comprises a first fluid reservoir (106) that defines a first internal reservoir volume (281); The first internal reservoir volume includes the first plunger (108); kit.

5. A kit according to claim 4, The second closed sterile internal volume (214) of the second packaging container (210) further comprises a contrast fluid line (226) having a first contrast fluid line end (224) and a second contrast fluid line end (226); The first contrast fluid line end is connected to the manifold inlet (216) in the second closed sterile internal volume of the second packaging container. and The second contrast fluid line end is connected to the first fluid reservoir (106) within the second closed sterile internal volume of the second packaging container; kit.

6. A kit according to claim 5, The second closed sterile internal volume (214) of the second packaging container (210) further comprises a second fluid reservoir (106) that defines a second internal reservoir volume (281); The second internal reservoir volume includes the second plunger (108); kit.

7. A kit according to claim 2, The second cleaning fluid line end (234) is connected to a second fluid reservoir (106) provided within the second closed sterile internal volume (214) of the second packaging container (210). kit.

8. A kit according to claim 1, The patient interface connector (127) further includes a further patient interface exit (258), and The valve (259) of the patient interface connector is configured to selectively allow fluid to be communicated from the patient interface inlet (256) to either the patient interface outlet (257) or the further patient interface outlet (258). kit.

9. A kit according to claim 2, The manifold connector (124) includes a manifold valve (222), The manifold valve is configured to move in response to a change in pressure at the manifold connector between a first manifold valve position that prevents fluid communication from the manifold inlet (216) to the manifold outlet (220) and a second manifold valve position that prevents fluid communication from a further manifold inlet (218) to the manifold outlet. kit.

10. A kit according to claim 1, The first packaging container (205) includes a faceplate (260), and the second packaging container (210) includes a faceplate (265). The faceplate (260) of the first packaging container is positioned over the area of ​​the first packaging container (205) where the opening (236a) is provided, and the faceplate (265) of the second packaging container is positioned over the area of ​​the second packaging container (210) where the opening (236b) is provided. The faceplate (265) of the second packaging container is configured to be detachably connected to the faceplate (260) of the first packaging container. kit.

11. A kit according to claim 10, The front panel (265) of the second packaging container (210) includes a connecting element (270b) configured to be detachably connected to a corresponding connecting element (270a) included in the front panel (260) of the first packaging container (205), kit.

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