Injection Setup Kit and Method

Abstract

The injection set kit can include a manifold connector, a first packaging container, and a fluid line. The first packaging container can define a first enclosed interior volume including a patient interface connector, the 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 can be fluidically connected to the manifold outlet. The fluid line can have a first fluid line end and a second fluid line end. The first fluid line end can be connected to the patient interface inlet within the first enclosed interior volume. The second fluid line end can extend outside the first enclosed interior volume and be connected to the manifold outlet outside the first enclosed interior volume.

Description

[0001] Related applications

[0002] This application claims priority to U.S. patent application No. 17 / 006,973, filed on August 31, 2020, the contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to the field of medical technology and, more particularly, to kits and methods for injection systems. Background Art

[0004] Injection systems can be used in a variety of medical applications. For example, injection systems can be used to introduce fluids into a patient's body to facilitate medical diagnostic procedures and / or interventional procedures. In some such procedures, this fluid can help collect information such as image data at a region of interest in the patient's body. The collected information can be used to determine characteristics related to the diagnostic procedure and / or to guide the placement of one or more medical devices during the interventional procedure.

[0005] However, a considerable amount of time and attention may be required to properly set up the injection system. Setting up the injection system may require the connection of multiple components. For example, certain injection system components are intended to be used for a limited number of uses (e.g., single use) and need to be replaced frequently. Additionally, in some cases, once the component connections are made, setting up the injection system may require certain actions to be performed before the fluid can be introduced into the patient. One such action may be an air purge, in which fluid is conveyed through the connected injection system components to remove any air entrained in these components. In some cases, in order to maintain the sterility of certain components, some setup actions are taken by a non-sterile user, while other setup actions are taken by a sterilized user. Therefore, a considerable amount of time and attention may be required to properly set up the injection system on behalf of multiple users. Summary of the Invention

[0006] In general, various embodiments related to injection setup kits and methods are disclosed herein. Various such embodiments can be used, for example, to facilitate a more efficient workflow when preparing a fluid injection system for use. The embodiments disclosed herein can allow certain fluid injection system components to be set up before an application requiring a fluid injector, while maintaining the sterility of certain components. Notably, the embodiments disclosed herein can allow certain components to be pre-set up while the procedural environment is relatively calm, as such setup can occur before an emergency situation where time pressure would otherwise exist. Thus, when the need to use the fluid injection system arises later, the time and attention required to get the injection system ready for use is greatly reduced. This can be particularly valuable in fluid injection applications where time is of the essence. For example, in certain applications, the difference between a successful procedure and irreversible anatomical trauma (e.g., irreversible cardiac muscle trauma) can be a matter of seconds. Therefore, by reducing the time spent preparing the injection system for use in a procedure, the embodiments disclosed herein can increase the likelihood of procedural success.

[0007] One embodiment includes an injection setup kit. This injection setup kit embodiment 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 enclosed interior volume. The first enclosed interior volume may include a patient interface connector having a patient interface inlet, a first patient interface outlet, and a valve configured to selectively allow fluid to be communicated from the patient interface inlet to the first patient interface outlet through the patient interface connector. 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 enclosed interior volume of the first packaging container. The second fluid line end may extend outside the first enclosed interior volume of the first packaging container and may be connected to the manifold outlet outside the first enclosed interior volume of the first packaging container.

[0008] Another embodiment of the injection setup kit includes a second packaging container separate from the first packaging container. In this embodiment, the second packaging container defines a second enclosed interior volume. The second enclosed interior volume may include the manifold connector. The second fluid line end may extend outside the first enclosed interior volume of the first packaging container and into the second enclosed interior volume of the second packaging container, so that the second fluid line end is connected to the manifold outlet within the second enclosed interior volume of the second packaging container.

[0009] Another embodiment includes a method for setting up an injection system. This embodiment of the method includes 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 within the enclosed interior volume of a second packaging container. After opening the first packaging container, this embodiment of the method includes fluidically connecting the first manifold inlet to a contrast fluid reservoir. The contrast fluid reservoir may define a first interior reservoir volume including a first plunger. After connecting the first manifold inlet to the contrast fluid reservoir, this embodiment of the method includes delivering a contrast fluid from the contrast fluid reservoir along the fluid line to a fluid collection receptacle within the enclosed interior volume of the second packaging container. After delivering the contrast fluid to the fluid collection receptacle, this embodiment of the method includes opening a second packaging container and removing the other end of the fluid line, the fluid collection receptacle, and a patient interface connector in fluid communication with the fluid line from the second packaging container. Furthermore, after opening the second packaging container, this embodiment of the method includes fluidically connecting the patient interface connector to an injection catheter.

[0010] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The following drawings are illustrative of specific embodiments of the present invention and are not intended to limit the scope of the present invention. The drawings are intended to be used in conjunction with the explanations in the following description. The embodiments of the present invention will be described below with reference to the accompanying drawings, wherein like numbers represent like elements.

[0012] Figure 1 is a perspective view of an embodiment of a fluid injector.

[0013] Figure 2 is a schematic diagram illustrating an embodiment of an injection setup kit including an exemplary first packaging container and an exemplary second packaging container.

[0014] Figure 3 It shows Figure 2 A schematic diagram of the first packaging container, but Figure 2 The second packaging container is removed. Figure 3 Components are shown that were previously enclosed in a second packaging container and connected to corresponding components of the injection system.

[0015] Figure 4 It shows Figure 2 Schematic diagram of the first packaging container and the second packaging container both being removed. Figure 4Components are shown which were previously enclosed in a second packaging container and connected to corresponding components of the injection system. Figure 4 Also shown are certain components that were previously enclosed in the first packaging container and connected to the injection catheter.

[0016] Figure 5 is a schematic diagram illustrating another embodiment of an injection setup kit including an exemplary first packaging container and an exemplary second packaging container.

[0017] Figure 6 is a schematic diagram illustrating another embodiment of an injection setup kit including an exemplary first packaging container and an exemplary second packaging container.

[0018] Figure 7 is a flow chart of an embodiment of a method of setting up an injection system. DETAILED DESCRIPTION

[0019] The following detailed description is exemplary in nature and is not intended to limit the scope, applicability or configuration of the present invention in any way. On the contrary, the following description provides some practical examples for realizing embodiments of the present invention. Examples of construction, materials, and / or sizes are provided for selected elements. It will be appreciated by those skilled in the art that many of the examples mentioned have various suitable alternatives.

[0020] Figure 1 A perspective view of an exemplary embodiment of a fluid injector 100 is shown. In operation, the fluid injector 100 can inject a certain amount of fluid into a patient via a catheter, for example, into a patient's blood vessel. The fluid injected by the fluid injector 100 can be, for example, a contrast fluid, a non-contrast fluid (e.g., saline), or a combination thereof. By injecting a certain amount of fluid into the patient, the fluid injector 100 can facilitate various medical diagnostic procedures and / or interventional procedures, including collecting image data showing an anatomical region of interest. As an example, such procedures can include optical coherence tomography (OCT) imaging, intravascular ultrasound (IVUS) imaging, computed tomography (CT) imaging, magnetic resonance imaging (MRI) imaging, angiography procedures, and interventional device procedures / placement.

[0021] The illustrated fluid injector 100 includes a drive assembly housing 102 and a sleeve 104. The sleeve 104 can be secured to the drive assembly housing 102. For example, the drive assembly housing 102 can include an opening, and the sleeve 104 can be secured to the drive assembly housing 102 at or near such an opening. The sleeve 104 can extend from the drive assembly housing 102 and can be configured to receive and secure a fluid reservoir 106 therein. Although Figure 1The example shown in Figure 1 shows a fluid reservoir 106, but other fluid injector 100 embodiments may include two (or more) fluid reservoirs 106 and a corresponding number of sleeves 104. Fluid reservoir 106 can define an internal reservoir volume including plunger 108. At least a portion of the drive assembly can be contained within the drive assembly housing 102. The drive assembly can be configured to pressurize the fluid within the internal reservoir volume. For example, the drive assembly can be coupled to plunger 108, such as at an opening in the drive assembly housing 102, and drive plunger 108 within the internal reservoir volume of the fluid reservoir 106. As plunger 108 is progressively driven within the fluid reservoir 106, the fluid within the internal reservoir volume can be pressurized and output from the fluid reservoir 106 along a fluid line 109 leading to the patient. In some applications of the fluid injector 100, the output fluid such as a contrast medium can be pressurized to any value (e.g., 1200 psi) within 1000 psi to 1500 psi. In embodiments including two (or more) fluid reservoirs 106 , a corresponding number of drive assemblies may be housed within the drive assembly housing 102 for pressurizing the fluid within each fluid reservoir.

[0022] The illustrated embodiment of the fluid injector 100 includes several features that can be used to pressurize and deliver the 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 operational aspects. For example, the operator can use the control panel 110 to set various parameters and / or protocols to be used for a given fluid injection program. The control panel 110 can also be used to initialize the fluid injector 100 (for example, to prepare the fluid injector 100 for patient fluid injection), or to start certain features or operational sequences. In some cases, as shown here, a hand controller 113 can be coupled to the control panel 110 and used by the operator to remotely input signals related to the injection to the fluid injector 100. The control panel 110 can also provide status information, including information related to past or currently ongoing injection programs and any appropriate alarms. The control panel 110 may include an imaging engine having one or more processors for controlling the operation of the electric fluid injector 100. Such a processor may also communicate with and / or control other components connected to the fluid injector 100, such as the drive assembly, the peristaltic pump 112 (when present), and / or any sensors and detectors (e.g., the air detection sensor 126 and / or the hemodynamic pressure transducer 128).

[0023] Fluid injector 100 can also include one or more components that can be used for supplying the fluid that will be used in the injection procedure. In the application that two kinds of fluid will be injected into the patient, fluid supply container 114 and fluid supply container 118 can be fluidically coupled to fluid injector 100. As an example, fluid supply container 114 can be a contrast fluid supply container, and fluid supply container 118 can be a saline fluid supply container. As shown here, retainer 116 can be included in fluid injector 100 to keep fluid supply container 114, and retainer 120 can be included in fluid injector 100 to keep fluid supply container 118. In the embodiment shown, the fluid (for example, contrast fluid) from fluid supply container 114 can be supplied to fluid reservoir 106 to use during the injection procedure. For example, the fluid from fluid supply container 114 can be drawn into fluid reservoir 106 when plunger 108 retracts (for example, moving in the direction toward drive assembly housing 102), thus refilling internal reservoir volume. In the illustrated embodiment, the fluid injector 100 includes a peristaltic pump 112 for delivering fluid from a fluid supply container 118 to a patient. Typically, the peristaltic pump 112 can be used to deliver a non-contrast fluid (such as saline) at a lower pressure than the pressure at which the drive assembly delivers the contrast fluid from the reservoir 106. However, as noted, in other embodiments, the fluid injector 100 can include a second fluid reservoir 106 and use a corresponding drive assembly housed within the drive assembly housing 102 to pressurize and deliver the non-contrast fluid from the fluid supply container 118. In some such embodiments, instead of the peristaltic pump 112, a second fluid reservoir 106 and corresponding drive assembly can be present.

[0024] A manifold connector 124 may be included to selectively allow one of the fluid reservoir 106 and the peristaltic pump 112 (or the second fluid reservoir 106, depending on the embodiment) to communicate with the patient. Thus, the manifold connector 124 can selectively allow 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 from allowing one of the fluid reservoir 106 and the fluid supply container 114 to communicate with the patient fluid to allowing the other of the peristaltic pump 112 (or the second fluid reservoir 106, depending on the embodiment) and the fluid supply container 118 to communicate with the patient fluid. A patient interface connector 127 may also be included, for example, at the fluid line 109 to selectively allow fluid (such as fluid from the manifold connector 124) to pass through the patient interface connector 127, such as to a patient engagement member (e.g., a catheter, such as an infusion catheter). The patient interface connector 127 may include a valve configured to selectively allow fluid to be transferred through the patient interface connector 127.

[0025] As described above, one or more sensors can be connected to the fluid injector 100 to provide information relevant to the injection. 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 can be configured to detect the presence of air (e.g., one or more bubbles) in one or more components. As shown here, the air detection sensor 126 can be configured to detect the presence of air in the fluid line 109 at a position between the outlet of the manifold connector 124 and the patient. For example, the fluid line 109 can have an air detection interface, and the air detection sensor 126 can detect the presence of air in the fluid line 109 at this air detection interface. When such air is detected, the air detection sensor 126 can output a signal at the fluid injector 100, and the fluid injector 100 can take corresponding actions, such as stopping the injection and / or providing a warning to the user. The hemodynamic pressure transducer 128 can be configured to measure the pressure in the fluid line 109, for example. When the manifold connector 124 is open to place the hemodynamic pressure transducer 128 in fluid communication with the patient, the hemodynamic pressure transducer 128 may output a signal corresponding to the pressure inside the patient.

[0026] Preparing a fluid syringe for use may require multiple steps. Because some components used in fluid injection are routinely replaced (e.g., after a single use), preparing a fluid syringe for use may include frequently replacing and appropriately connecting new components. Once these new components are connected, preparing the fluid syringe may also include an air purge process (e.g., before fluid is introduced into the patient from the fluid syringe 100). The air purge process can remove any air contained in the injection component so that air is not introduced into the patient during injection. These steps may consume a lot of time and require detailed attention. However, some fluid syringe applications may be time-sensitive and may make it difficult to pay attention to the details required to appropriately prepare a fluid syringe for such application in real time.

[0027] The embodiment described in the present disclosure can facilitate more efficient workflow when preparing the fluid injector for use. For example, the embodiment disclosed herein can allow certain components to be set at the fluid injector before the application of the fluid injector is needed, while maintaining the sterility of other components. More specifically, the embodiment can allow various components to be connected to the fluid injector and be convenient to the air purge process before the application of the fluid injector is needed. Meanwhile, when making necessary connections and performing the air purge process, the packaging container can maintain the sterile environment around the other components. Then, when the demand for using the fluid injector occurs later, removing the packaging container and being connected to the patient component (for example, an injection catheter) can be the only preparation required for using the fluid injector at that time. Therefore, when it is necessary to use the fluid injector, the embodiment within the scope of the present disclosure can reduce the time required for preparing for fluid injection. This can be particularly useful in time-sensitive injection applications.

[0028] Taking all things into consideration, Figure 2-4 An exemplary sequence involving the injection setup kit and the corresponding setup of the injection system is shown. Figure 2 Start with the initial injection setup kit provided in the Figure 3 In the exemplary sequence, the components are removed from one packaging container while the other packaging container remains closed. Figure 4 In the process, the injection system is set up and ready for use.

[0029] Figure 2 A schematic diagram of an embodiment of an injection setup kit 200 is shown. Figure 2 The injection setting kit 200 shown in comprises the embodiment of the first packing container 205 and the embodiment of the second packing container 210. Each in the first packing container 205 and the second packing container 210 can enclose one or more components. The second packing container 210 can be a packing container separated from the first packing container 205. When packing container 205, 210 is a separated packing container, opening one in the first packing container 205 and the second packing container 210 can allow to remove one or more components enclosed therein, while keeping one or more components enclosed in another in the first packing container 205 and the second packing container 210. Like this, the injection setting kit 200 can allow to set certain components in the fluid injection system, while maintaining the sterile environment around other components that are enclosed in the unopened packing container. Therefore, the injection setting kit 200 can be configured to allow to open a packing container (such as the second packing container 210) and remove components therein, while maintaining the sterile environment in another packing container (such as the first packing container 205).

[0030] First packaging container 205 can define a first closed interior volume 212. First packaging container 205 can enclose first closed interior volume 212. In some embodiments, first packaging container 205 encloses first closed interior volume 212 so that one or more components within first closed interior volume 212 cannot be removed until first packaging container 205 is opened. In one embodiment, when an action is taken to open, first closed interior volume 212 is no longer considered "closed," and thus the configuration of first packaging container 205 is physically changed. For example, first packaging container 205 can be sealed around first closed interior volume 212 to enclose first closed interior volume 212. This can include sealing first packaging container 205 around the perimeter of any components extending outside first closed interior volume 212. In various embodiments, first packaging container 205 can enclose first closed interior volume 212 so that first closed interior volume 212 defines a sterile environment.

[0031] Similarly, second packaging container 210 can define a second closed interior volume 214. Second packaging container 210 can enclose second closed interior volume 214. In some embodiments, second packaging container 210 encloses second closed interior volume 214 so that one or more components within second closed interior volume 214 cannot be removed until second packaging container 210 is opened. In one embodiment, when an action is taken to open, second closed interior volume 214 is no longer considered "closed," and thus the configuration of second packaging container 210 is physically changed. For example, second packaging container 210 can be sealed around second closed interior volume 214 to enclose second closed interior volume 214. This can include sealing second packaging container 210 around the perimeter of any components extending outside second closed interior volume 214. In various embodiments, second packaging container 210 can enclose second closed interior volume 214 so that second closed interior volume 214 defines a sterile environment.

[0032] Depending on the particular embodiment, any number of various components may be included within the first enclosed interior volume 212 and the second enclosed interior volume 214. The exemplary embodiment of the injection setup kit 200 described herein includes components within the first enclosed interior volume 212 and the second enclosed interior volume 214 that are suitable for facilitating a more efficient workflow when preparing a fluid injector for use. In particular, the illustrated injection setup kit 200 can allow certain components to be set up at the fluid injector prior to an application requiring the fluid injector, while maintaining the sterility of other components to be used later during a fluid injection operation in conjunction with a patient procedure.

[0033] like Figure 2As shown in the embodiment of FIG, a patient interface connector 127 is included within the first enclosed interior 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 flow from the patient interface inlet 256 through the patient interface connector 127 to the first patient interface outlet 257. Figure 2 , the patient interface connector 127, while enclosed within the first enclosed interior volume 212, can be fluidly connected to the manifold connector 124. In particular, the patient interface inlet 256 can be fluidly connected to the manifold outlet 220 of the manifold connector 124 via the fluid line 109. Thus, within the first enclosed interior volume 212, the patient interface inlet 256 can be fluidly connected to the manifold outlet 220.

[0034] In some cases, as shown here, patient interface connector 127 can also include a second patient interface outlet 258. In some examples, second patient interface outlet 258 can serve as a flush outlet. For example, second patient interface outlet 258 can provide an outlet to remove unwanted material from fluid line 109, such as air bubbles or fluid retained therein from a previous operation (for example, removing the residual contrast fluid retained in fluid line 109 before providing flush fluid by fluid line 109). When second patient interface outlet 258 is included, valve 259 can be configured to selectively allow fluid to be communicated to any one of first patient interface outlet 257 and second patient interface outlet 258 from patient interface inlet 256 through patient interface connector 127. For example, after first packaging container 205 has been opened, valve 259 can be manually actuated by a user so that one of first patient interface outlet 257 and second patient interface outlet 258 is communicated with patient interface inlet 256 fluid, while blocking the fluid communication to another of first patient interface outlet 257 and second patient interface outlet 258.

[0035] In some embodiments, the first enclosed interior volume 212 of the first packaging container 205 may further include a fluid collection receptacle 250. The fluid collection receptacle 250 may be configured to receive and retain fluid. Within the first enclosed interior volume 212, the first patient interface outlet 257 may be fluidly connected to the fluid collection receptacle 250. In particular, as Figure 2In the illustrated embodiment, the first patient interface outlet 257 can be fluidly connected to a fluid collection receptacle 250 such that the fluid collection receptacle 250 is in fluid communication with the manifold outlet 220 via the fluid line 109 and the patient interface connector 127. Thus, the fluid collection receptacle 250 can be configured to receive and retain fluid output from the manifold outlet 220. As further described herein, the fluid collection receptacle 250 can be used to collect fluid prior to injecting the fluid into a patient. For example, the fluid collection receptacle 250 can be used to collect fluid during setup of the fluid injection system (e.g., during an air purge procedure).

[0036] A first fluid line end 227 may also be included within the first enclosed interior volume 212 of the first packaging container 205. The injection 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 the patient interface inlet 256 within the first enclosed interior volume 212 of the first packaging container 205. The second fluid line end 229 may extend outside the first enclosed interior volume 212 of the first packaging container 205. Thus, in this configuration, prior to opening the first packaging container 205, a portion of the fluid line 109 may be within the first enclosed interior volume 212, while another portion of the fluid line 109 may be outside the first enclosed interior volume 212.

[0037] like Figure 2 In the embodiment shown in FIG, a manifold connector 124 is included within the second enclosed interior volume 214 of the second packaging container 210. 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 place one of the first manifold inlet 216 and the second manifold inlet 218 in fluid communication with the manifold outlet 220.

[0038] In one embodiment, to facilitate such 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 the first manifold inlet 216 and another position that blocks the second manifold inlet 218. For example, the manifold valve 222 may be configured to move between such positions in response to changes in fluid pressure at the manifold connector 124. In this manner, the manifold valve 222 may be configured to move between the first manifold valve position (e.g., in the second manifold valve position) in response to changes in pressure at the manifold connector 124. Figure 2 ) and the second manifold valve position (e.g., Figure 4216 to the manifold outlet 220, and the manifold valve 222 blocks fluid communication from the first manifold inlet 216 to the manifold outlet 220. In some embodiments, the manifold valve 222 can be biased (e.g., via a biasing member, such as a spring) to the first manifold valve position. Then, when the pressure at the first manifold inlet 216 reaches a predetermined threshold, the biasing force of the manifold valve 222 can be overcome, causing the manifold valve 222 to move to the second manifold valve position.

[0039] In some embodiments, the second closed interior 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 detection of the presence of air in the fluid line 109. For example, the air detection interface 239 may be configured to engage with the air detection sensor 126 and allow the air detection sensor 126 to detect the presence of air in the fluid line 109. Thus, the air detection sensor 126 may detect the presence of air (e.g., one or more bubbles) in the fluid line 109, such as 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, such as at the manifold outlet 220. Figure 2 . In particular, in the illustrated embodiment, an air detection interface 239 is included at 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 downstream of the manifold outlet 220 and within the second enclosed interior volume 214.

[0040] In one embodiment, for example, Figure 2 In the embodiment shown in FIG, the second enclosed interior volume 214 of the second packaging container 210 may further include a flushing fluid line 230. The flushing fluid line 230 may have a first flushing fluid line end 228 and a second flushing fluid line end 234. The first flushing fluid line end 228 may be connected to the second manifold inlet 218 within the second enclosed interior volume 214 of the second packaging container 210. As shown in the illustrated embodiment, both the first flushing fluid line end 228 and the second flushing fluid line end 234 may be located within the second enclosed interior volume 214. In another embodiment, the second enclosed interior 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 not be any fluid line connected to either the first manifold inlet 216 or the second manifold inlet 218 within the second enclosed interior volume 214 of the second packaging container 210.

[0041] A second fluid line end 229 of the fluid line 109 may also be included within the second enclosed interior volume 214 of the second packaging container 210. The second fluid line end 229 may be connected to the manifold outlet 220 of the manifold connector 124. Figure 2 , the second fluid line end 229 extends outside the first enclosed interior volume 212 of the first packing container 205 and is connected to the manifold outlet 220 outside the first enclosed interior volume 212 of the first packing container 205. In particular, as shown here, the second fluid line end 229 extends outside the first enclosed interior volume 212 of the first packing container 205 and extends into the second enclosed interior volume 214 of the second packing container 210 and is connected to the manifold outlet 220 within the second enclosed interior volume 214 of the second packing container 210.

[0042] To facilitate extending one or more component parts (e.g., a portion of fluid line 109) outside of first enclosed interior volume 212, first packaging container 205 can include one or more apertures 236a. For example, first packaging container 205 can define aperture 236a through which at least second fluid line end 229 of fluid line 109 extends outside of first enclosed interior volume 212 of first packaging container 205. Where more than one component part extends outside of first enclosed interior volume 212, first packaging container 205 can define an aperture for each such component part that extends outside of first enclosed interior volume 212. However, where more than one component part extends outside of first enclosed interior volume 212, first packaging container 205 can define a single common aperture (e.g., aperture 236a) through which each component part extends outside of first enclosed interior volume 212.

[0043] The orifice 236a can be sized to enclose (e.g., seal) the first enclosed interior volume 212 at one or more portions that extend outside the first enclosed interior volume 212. For example, the orifice 236a can be sized to enclose the first enclosed interior volume 212 around the outer circumferential surface of the fluid line 109. In this example, the first packaging container 205 can contact the outer circumferential surface of the fluid line 109 at the location of the orifice 236a. Thus, the orifice 236a can be sized to allow one or more intended components (e.g., the fluid line 109) to extend from the first enclosed interior volume 212, but prevent other components from extending from the first enclosed interior volume 212. For example, the orifice 236a can be sized to prevent the patient interface connector 127 from extending outside the first enclosed interior volume 212.

[0044] exist Figure 2In the embodiment shown in FIG, one or more component portions extending outside the first enclosed interior volume 212 may extend into the second enclosed interior volume 214 of the second packaging container 210. For example, Figure 2 As shown in FIG, a portion of the fluid line 109 extends outside the first enclosed interior volume 212 and into the second enclosed interior volume 214. As such, the second fluid line end 229 can extend into the second enclosed interior volume 214.

[0045] To facilitate extending one or more component parts (e.g., a portion of fluid line 109) into second enclosed interior volume 214, second packaging container 210 may include one or more apertures 236b. For example, second packaging container 210 may define aperture 236b through which at least second fluid line end 229 extends into second enclosed interior volume 214 of second packaging container 210. Where more than one component part extends into second enclosed interior volume 214, second packaging container 210 may define an aperture for each such component part that extends into second enclosed interior volume 214. However, where more than one component part extends into second enclosed interior volume 214, second packaging container 210 may define a single common aperture (e.g., aperture 236b) through which each component part extends into second enclosed interior volume 214.

[0046] In one embodiment, the orifices 236b (when included) can correspond to the orifices 236a (when included). For example, the orifices 236b can be sized to enclose the second enclosed interior volume 214 at one or more component portions extending into the second enclosed interior volume 214, and the orifices 236b can be the same size as the corresponding orifices 236a. In the embodiment shown, the orifices 236b can be sized to enclose the second enclosed interior volume 214 around the outer peripheral surface of the fluid line 109.

[0047] Figure 2 The injection setup kit 200 shown in FIG includes a first packaging container 205 engaged with a second packaging container 210. In the embodiment shown, the aperture 236a of the first packaging container 205 is engaged with the aperture 236b of the second packaging container 210. The aperture 236a included in the first packaging container 205 can be aligned with the aperture 236b included in the second packaging container 210.

[0048] In certain embodiments, first packing container 205 and second packing container 210 can be removably coupled together.For example, first packing container 205 and second packing container 210 can be removably coupled together at the public packing area that packing container 205,210 engages.In the embodiment shown, first packing container 205 comprises panel 260, and second packing container 210 comprises panel 265.Panel 260,265 can be made by (for example, more ridged) material different from the material of packing container 205,210.As shown here, panel 260 can be positioned on the zone with orifice 236a of first packing container 205, and can be that panel 260 limits the orifice 236a in first packing container 205 in some cases.And panel 265 can be positioned on the zone with orifice 236b of second packing container 210, and can be that panel 265 limits the orifice 236b in second packing container 210 in some cases. The panel 265 of the second packaging container 210 can be configured to be removably coupled to the panel 260 of the first packaging container 205. For example, the panel 265 can include a connecting element 270b that is configured to be removably coupled to a corresponding connecting element 270a included at the panel 260. The corresponding connecting elements 270a, 270b can be any of various suitable connecting elements, such as interference fit components (e.g., buttons or other sliding or snap fit components). In other cases, instead of different connecting elements or in addition to different connecting elements, the panels 260, 265 can include an adhesive or a tear-away coupling portion therebetween.

[0049] Figure 3 An exemplary schematic diagram is shown showing the first packaging container 205 as before, but with the second packaging container removed. Figure 3 As shown in , when the second packaging container is opened, those components that are removed from the second packaging container can be connected to corresponding components of the injection system.

[0050] When the second packaging container is opened and removed from the injection setup kit, first packaging container 205 can be configured to continue to enclose first closed interior volume 212 and those components included in first closed interior volume 212. For example, first packaging container 205 can include attachment member 206, which is configured to allow first packaging container 205 to be removably fixed to a fluid injector, such as at drive assembly housing 102. In one embodiment, the fluid injector can have a corresponding attachment member configured to removably receive attachment member 206. This can allow the first packaging container to be temporarily placed in a known and convenient location while those components removed from the second packaging container are connected to the injector and the injection system is set up.

[0051] In this way, the second packing container can be opened and the second packing container can be removed from the injection setting suite when the first packing container 205 is not opened.This can be the situation that the first and second packing containers are separated containers.And, when the first packing container and the second packing container engage and are removably coupled together, the removable coupling (for example, via panel) therebetween can be configured to allow the second packing container to be removed when the first packing container 205 is not opened.For example, when the second packing container is removed from the injection setting suite, the first packing container 205 can be configured to maintain the sterile environment in the first sealed inner volume 212. In addition, as shown here, when the second packing container is removed from the injection setting suite, the first packing container 205 can be configured to maintain the first fluid line end 227 to be connected to patient interface inlet 256 in the first sealed inner volume 212 of the first packing container 205.

[0052] The second packaging container can be opened, and one or more components included in the second packaging container can be removed and connected to one or more corresponding fluid injection system components. For example, opening the second packaging container can include introducing the internal volume defined by the second packaging container into the surrounding environment so that the second packaging container no longer defines a second closed internal volume when opened. At the same time, opening and removing the second packaging container can include maintaining the closed internal volume 212 of the first packaging container 205 and the sterile environment within the closed internal volume 212.

[0053] In the illustrated embodiment, opening the second packaging container can include removing manifold connector 124 from the second packaging container. When removed from the second packaging container, manifold connector 124 can be connected to second fluid line end 229 while first fluid line end 227 is within first enclosed interior volume 212 of first packaging container 205. Thus, removing manifold connector 124 from the second packaging container can include removing second fluid line end 229 from the second packaging container. In other embodiments, second fluid line end 229 can be disconnected from manifold connector 124 while enclosed within the second packaging container, and the user can connect second fluid line end 229 to manifold connector 124 after removing the second packaging container. As shown here, when manifold connector 124 is removed from the second packaging container, fluid line 109 can extend through aperture 236a included in first packaging container 205, and first fluid line end 227 can be connected to patient interface inlet 256 within first enclosed interior volume 212.

[0054] After the second packaging container is opened and the manifold connector 124 is removed, the manifold connector 124 can be connected to a fluid injector, such as fluidically connected to one or more fluid supply containers 114, 118. In particular, after the second packaging container is opened and the manifold connector 124 is removed, the manifold connector 124 can be connected to at least one fluid reservoir 106. In the embodiment shown, the manifold connector 124 is fluidically connected to two fluid reservoirs 106. Figure 3 As shown in FIG, the first manifold inlet 216 can be fluidly connected to one fluid reservoir 106, and the second manifold inlet 218 can be fluidly connected to another fluid reservoir 106. Specifically, the first manifold inlet 216 can be fluidly connected to the one fluid reservoir via a contrast fluid line 226. The contrast fluid line 226 can 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 the 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. Furthermore, the second manifold inlet 218 can be fluidly connected to the other fluid reservoir 106 via a flush fluid line 230. The first flush fluid line end 228 can be fluidly connected to the second manifold inlet 218, and the second flush fluid line end 234 can be fluidly connected to a reservoir outlet 284 of the other fluid reservoir 106.

[0055] As previously described, in some embodiments, the second packaging container can include a flushing fluid line 230. In these embodiments, opening the second packaging container can include removing the flushing fluid line 230 from the second packaging container. In these embodiments, prior to opening the second packaging container, the first flushing fluid line end 228 is fluidically connected to the second manifold inlet 218. Thus, for these embodiments, connecting the second manifold inlet 218 to the fluid injector can simply include fluidically connecting the second flushing fluid line end 234 to the reservoir outlet 284 of another fluid reservoir 106.

[0056] Additionally, in the illustrated embodiment, opening the second packaging container may include removing the air detection interface 239 from the second packaging container. For example, as in the illustrated embodiment, when the air detection interface 239 is located in the region of the fluid line 109, the air detection interface 239 may be removed from the second packaging container when a portion of the fluid line 109 is removed from the second packaging container. Figure 3 As shown in , when the air detection interface 239 is removed from the second packaging container, the air detection interface 239 can be positioned to engage with the air detection sensor 126 so that the presence of air in the fluid line 109 can be detected.

[0057] When one or more components to be removed from the second packaging container are connected to corresponding components of the injection system, such as Figure 3 , further actions may be taken to prepare the injection system for later use by the patient. Such further actions may be taken while certain components remain enclosed within the first closed interior volume 212 of the first packaging container 205. As an example, to prepare the injection system for later use by the patient, one or more air purge actions may be taken while one or more components removed from the second packaging container are connected to components of the injection system and while certain components remain enclosed within the first closed interior volume 212.

[0058] After connecting the manifold connector 124 to the fluid injector, such as Figure 3 As shown in , fluid may be delivered through manifold connector 124 , fluid lines 109 , and patient interface connector 127 .

[0059] For example, after connecting the first manifold inlet 216 to the contrast fluid supply container 114, the contrast fluid can be delivered from the contrast fluid supply container 114 along the contrast fluid line 226 to the fluid collection receptacle 250 within the enclosed interior volume 212 of the first packaging container 205. This can include delivering the contrast fluid through the manifold connector 124, the fluid line 109, and the patient interface connector 127, wherein the first fluid line end 227 and the patient interface connector 127 are fluidly connected within the enclosed interior volume 212. For example, the manifold valve 222 can be in a position blocking the second manifold inlet 218, and the contrast fluid can be delivered through the first manifold inlet 216 and out the manifold outlet 220. Additionally, the valve 259 can be in a position allowing fluid to communicate from the patient interface inlet 256 to the first patient interface outlet 257 and then into the fluid collection receptacle 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 having 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. Delivery of contrast fluid along the contrast fluid line 226 to the fluid collection receptacle 250 can be used to purge air from components connected in the contrast fluid path, including those within the enclosed interior volume 212.

[0060] Additionally, after connecting the second manifold inlet 218 to the flush fluid supply container 118, flush fluid can be delivered from the flush fluid supply container 118 along the flush fluid line 230 to the fluid collection receptacle 250 within the enclosed interior volume 212 of the first packaging container 205. This can include routing the flush fluid through the manifold connector 124, the fluid line 109, and the patient interface connector 127, with the first fluid line end 227 and the patient interface connector 127 fluidly connected within the enclosed interior volume 212. For example, the manifold valve 222 can be in a position blocking the first manifold inlet 216, and flush fluid can be routed through the second manifold inlet 218 and out the manifold outlet 220. Additionally, the valve 259 can be in a position allowing fluid to flow from the patient interface inlet 256 to the first patient interface outlet 257 and then into the fluid collection receptacle 250. In the illustrated embodiment, the flushing fluid supply container 118 is fluidly connected to the fluid reservoir 106 via a flushing fluid supply fluid line 293 having a first flushing fluid supply line end 294 fluidly connected to the reservoir inlet 283 and a second flushing fluid supply line end 295 fluidly connected to the flushing fluid supply container 118. Delivery of flushing fluid along the flushing fluid line 230 to the fluid collection receptacle 250 can be used to purge air from components connected to the flushing fluid path, including those within the enclosed interior volume 212.

[0061] The ability to connect various components and purge air from these components can allow the fluid injection system to be set up before the fluid injection system is used on a patient later. This pre-setting can help reduce the time and energy required to prepare the fluid injection system when the fluid injection system is needed. Moreover, when this pre-setting occurs, the embodiments described herein can keep certain patient-engaging components of the injection system in a sterile environment, such as being kept in the first packaging container 205. In this way, when the injection system needs to be used by the patient, the setup time and energy are greatly reduced. This can allow the combined injection system to perform various diagnostic procedures faster, and the user burden is less during the setup process. This can help improve the results of such diagnostic procedures.

[0062] When it is necessary to perform an injection, the first packaging container can be removed and an injection catheter can be connected. Since the embodiments disclosed herein can allow for various setup steps to be performed in advance, these setup steps may not need to be performed when the need for an injection arises. For example, in one embodiment, the only step required may be to remove the first packaging container. In another embodiment, the only step required may be to remove the first packaging container and connect the injection catheter. In another embodiment, the only step required may be to remove the first packaging container, shift out the fluid collection receptacle, and connect the injection catheter.

[0063] Figure 4 An exemplary schematic diagram is shown, which shows that both the first packaging container and the second packaging container are removed. Figure 4 As shown in , one or more components removed from the second packaging container can be connected to corresponding components of the injection system, as shown in Figure 3 described. Moreover, Figure 4 As also shown in , one or more components removed from the first packaging container can be connected to an injection catheter. For example, the first packaging container can be opened after the second packaging container has been opened and after the one or more components previously located in the second packaging container are connected to the components of the injection system. In some cases, before opening the first packaging container, a contrast fluid and / or flushing fluid can be delivered (for example, as part of an air purge process) through one or more components previously located in the second packaging container and connected to the components of the injection system.

[0064] For example, in the illustrated embodiment, after the contrast fluid is delivered to the fluid collection receptacle, the first packaging container can be opened. Opening the first packaging container can include removing the patient interface connector 127 from the first packaging container. Because the patient interface connector 127 is connected to the first fluid line end 227, removing the patient interface connector 127 from the first packaging container can include removing the first fluid line end 227 from the first packaging container. Additionally, opening the first packaging container can include removing the fluid collection receptacle from the first packaging container.

[0065] like Figure 4 In the embodiment shown in Figure 2, once the first packaging container is opened, injection conduit 290 just can be fluidically connected to one or more members that were previously enclosed in the first packaging container.For example, in the illustrated embodiment, after opening the first packaging container, patient interface connector 127 can be fluidically connected to injection conduit 290. In this example, this can make each in fluid reservoir 106 and associated fluid supply container 114,118 be communicated with injection conduit 290 fluids. In the first packaging container, comprise a fluid collection receiver to for example remain on the embodiment of the fluid received before opening the first packaging container, can remove the fluid collection receiver after opening the first packaging container.For example, the fluid collection receiver can be removed from the first patient interface outlet 257, and injection conduit 290 can be connected to the first patient interface outlet 257. In case of disconnection, the fluid collection receiver just can be discarded.

[0066] The injection catheter 290 can be configured to be positioned at or within a patient and deliver fluid to the patient. After the injection catheter 290 is fluidically connected to, for example, the patient interface connector 127, one or more fluids can be delivered from a fluid injector to the injection catheter 290. For example, a contrast fluid can be delivered from a fluid reservoir 106 through the manifold connector 124 and along the fluid line 109 to the injection catheter 290. As another example, an irrigation fluid can be delivered from another fluid reservoir 106 through the manifold connector 124 and along the fluid line 109 to the injection catheter 290.

[0067] In the example shown here, the injection catheter 290 includes a fluid delivery port 291. The fluid delivery port 291 can be configured to receive fluid from the injection catheter 290. Figure 4 The fluid received by one or more components shown in the flow diagram is delivered to the patient (eg, at a region of interest within the patient's body).

[0068] Additionally, in the example shown here, the injection catheter 290 includes an imaging element 292. The imaging element 292 can be configured to collect image data and transmit the image data to an imaging engine for processing and / or display. In some cases, introducing fluid via the injection catheter 290 can improve the quality of the image data collected by the imaging element 292.

[0069] Figure 5 is a schematic diagram illustrating another embodiment of an injection setup kit 300. The injection setup kit 300 is similar to the injection setup kit 200 except that additional components are included in the second enclosed interior volume 214 of the second packaging container 210. Thus, Figure 5 Reference numerals used in the injection setup kit 300 are shown in to convey the presence of similar elements previously described with respect to the injection setup kit 200 .

[0070] The components within the first enclosed interior volume 212 of the first packaging container 205 included in the injection setup kit 300 are the same as those previously described for the injection setup kit 200. That is, the first enclosed interior volume 212 of the first packaging container 205 in the injection setup kit 300 includes the patient interface connector 127, the first fluid line end 227, and the fluid collection receptacle 250. The patient interface connector 127 is fluidly connected to both the fluid collection receptacle 250 and the first fluid line end 227 within the first enclosed interior volume 212.

[0071] The second enclosed interior volume 214 of the second packaging container 210 in the injection setup kit 300 includes the manifold connector 124. Figure 5As shown in FIG, the second enclosed interior volume 214 of the second packaging container 210 in the injection setup kit 300 also includes a contrast fluid line 226, a flush fluid line 230, a first fluid reservoir 106a, and a second fluid reservoir 106b. Each of the first fluid reservoir 106a and the second fluid reservoir 106b defines an interior reservoir volume 281. The interior reservoir volume 281 of each of the first fluid reservoir 106a and the second fluid reservoir 106b can include a plunger 108. Each of the first fluid reservoir 106a and the second fluid reservoir 106b can also include a reservoir outlet 284 (and in some embodiments, also include a reservoir inlet 283 as previously shown).

[0072] 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 the first manifold inlet 216 within the second enclosed interior volume 214 of the second packaging container 210. Furthermore, the second contrast fluid line end 232 is connected to the first fluid reservoir 106a within the second enclosed interior volume 214 of the second packaging container 210.

[0073] The flushing fluid line 230 has a first flushing fluid line end 228 and a second flushing fluid line end 234. The first flushing fluid line end 228 is connected to the second manifold inlet 218 within the second enclosed interior volume 214 of the second packaging container 210. Furthermore, the second flushing fluid line end 234 is connected to the second fluid reservoir 106b within the second enclosed interior volume 214 of the second packaging container 210.

[0074] When the second packaging container 210 is opened, the fluid reservoirs 106a, 106b, the contrast fluid line 226, the flushing 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 in a fluid connection state. When these components are removed from the second closed internal volume 214, the manifold connector 124 can be in fluid communication with the patient interface connector 127 via the fluid line 109. The fluid reservoirs 106a, 106b can be fixed to the corresponding sleeves 104 at the drive assembly housing 102 of the fluid injector. The fluid reservoirs 106a, 106b being fixed to the corresponding sleeves 104 can include coupling the corresponding plunger 108 to the drive assembly of the fluid injector so that the drive assembly can move the plunger 108 in the corresponding internal reservoir volume 281. Then, the fluid purge process can be performed in the manner described with respect to the injection setting kit 200.

[0075] By including at least one fluid reservoir 106a, 106b within the second closed interior volume 214 of the second packaging container 210, Figure 5 The injection setup kit 300 shown in FIG can further facilitate effective fluid injection system setup and initialization (e.g., air purge) before the fluid injection system is used in a patient procedure. At the same time, the injection setup kit 300 can maintain a sterile environment for certain components (e.g., those within the first enclosed interior volume 212 of the first packaging container 205) until the fluid injection system is used in a patient procedure.

[0076] Although the embodiment has been described with reference to the embodiment having a first packaging container and a second packaging container Figures 2 to 5 , but other embodiments within the scope of the present disclosure may include more than two packaging containers. For example, in addition to the first and second packaging containers, some embodiments may also include a third packaging container. The third packaging container may define a third enclosed interior volume that includes at least one component. In such embodiments, any one or more components disclosed herein may be located in the third packaging container rather than in the first and / or second packaging containers. Each of the first, second, and third packaging containers may define an enclosed interior volume that includes at least one component disclosed herein.

[0077] In an exemplary illustrative example of an embodiment comprising a first packing container, a second packing container, and a third packing container, the third enclosed interior volume of the third packing container may include a fluid collection receiver. In the exemplary illustrative embodiment, each of the first enclosed interior volume of the first packing container and the second enclosed interior volume of the second packing container may include one or more components as previously disclosed herein. For example, the third enclosed interior volume of the third packing container may include a fluid collection receiver, and the first patient interface outlet may be connected to the fluid collection receiver within the third enclosed interior volume. In this case, the patient interface inlet may be included within the first enclosed interior volume.

[0078] Figure 6 is a schematic diagram illustrating another embodiment of an injection setup kit 400. The injection setup kit 400 is similar to the injection setup kit 200, except that the components included in the first enclosed interior volume 212 of the first packaging container 205 and / or the second enclosed interior volume 214 of the second packaging container 210 may be different. Figure 6 Reference numerals for the injection setup kit 400 shown in FIG are used to convey the presence of similar elements previously described with respect to the injection setup kit 200 . Figure 6Components shown in dashed lines are components that may be optionally included in the injection setup kit 400 depending on the particular application in which the injection setup kit 400 is to be used.

[0079] The components included within the first enclosed interior volume 212 of the first packaging container 205 in the injection setup kit 400 are the first fluid line end 227 of the fluid line 109, the patient interface connector 127, and the fluid collection receptacle 250. The patient interface connector 127 is fluidly connected to both the fluid collection receptacle 250 and the first fluid line end 227 within the first enclosed interior volume 212.

[0080] Depending on the application in which the injection setup kit 400 is to be used, the first enclosed interior volume 212 of the first packaging container 205 in the injection setup kit 400 may include one or more other components. Figure 6 As shown in FIG, within the first enclosed interior volume 212 of the first packaging container 205 in the injection setup kit 400, one or more (e.g., each) of a valve 405, a pressure measuring device 410, and a first fluid line end 420 of a fluid line 415 may be included. In one embodiment, the valve 405 may be a check valve that allows fluid to flow toward the fluid collection receptacle 250 but restricts (e.g., prevents) fluid from flowing toward the second fluid line end 229. As shown here, the valve 405 may be located at the fluid line 109, but in other embodiments, the valve 405 may be located at another component within the first enclosed interior volume 212. In one embodiment, the pressure measuring device 410 may be a pressure transducer configured to measure the fluid pressure at the fluid line 109 and may be coupled to the first fluid line 109, for example. Furthermore, in one embodiment, the first fluid line end 420 of the fluid line 415 may be included within the first enclosed interior volume 212. The first fluid line end 420 may be coupled to a component within the first enclosed interior volume 212, depending on the application. As shown here, fluid line 415 can extend into first enclosed interior volume 212 via aperture 236a through which fluid line 109 extends into first enclosed interior volume 212. However, in another embodiment, a second aperture can be included at first packaging container 205 for separately extending fluid line 415 into first enclosed interior volume 212.

[0081] Included within the second enclosed interior volume 214 of the second packaging container 210 in the injection setup kit 400 are the second fluid line end 229 of the fluid line 109 and the air detection interface 239 .

[0082] Depending on the application in which the injection setup kit 400 is to be used, the second enclosed interior volume 214 of the second packaging container 210 in the injection setup kit 400 may include one or more other components. Figure 6 As shown in , the second enclosed interior volume 214 of the second packaging container 210 in the injection setup kit 400 may include a valve 425, a pressure measuring device 430, a manifold connector 124, a fluid reservoir 106, and one or more (e.g., each) of the second fluid line ends 421 of the fluid line 415.

[0083] In one embodiment, valve 425 can be a check valve that allows fluid to flow toward patient interface connector 127 but restricts (e.g., prevents) fluid from flowing toward second fluid line end 229. As shown here, valve 425 can be located at fluid line 109, but in other embodiments, valve 425 can be located at other components within second enclosed interior volume 214. In one example, only valve 405 or valve 425 can be included in kit 400, but in another example, both valve 405 and valve 425 can be included in kit 400.

[0084] In one embodiment, pressure measurement device 430 may be a pressure transducer configured to measure fluid pressure at fluid line 109 and may be coupled, for example, to first fluid line 109. In one example, only pressure measurement device 410 or pressure measurement device 430 may be included in kit 400, but in another example, both measurement devices 410 and 430 may be included in kit 400.

[0085] In one embodiment, the manifold connector 124 and / or the fluid reservoir 106 can be included in the second enclosed interior volume 214. When the manifold connector 124 is included, the second fluid line end 229 of the fluid line 109 can be fluidly connected to the manifold connector 124 (e.g., at the manifold outlet 220) within the second enclosed interior volume 214. For example, the second fluid line end 229 can include a luer connector configured to fluidly connect to a complementary luer connector at the manifold connector 124 (e.g., at the manifold outlet 220). When the fluid reservoir 106 is included in addition to the manifold connector 124, the reservoir 106 can be fluidly connected to the manifold connector 124 within the second enclosed interior volume 214 via a contrast fluid line 226 also included within the second enclosed interior volume 214.

[0086] Furthermore, in one embodiment, a second fluid line end 421 of the fluid line 415 can be included within the second enclosed interior volume 214. The second fluid line end 421 can be coupled to a component within the second enclosed interior volume 214, depending on the application. As shown here, the fluid line 415 can extend into the second enclosed interior volume 214 via an orifice 236b through which the fluid line 109 extends into the second enclosed interior volume 214. However, in another embodiment, a second orifice can be included at the second packaging container 210 for allowing the fluid line 415 to extend separately into the second enclosed interior volume 214.

[0087] As previously described herein, when second packing container 210 is opened, two or more of the components included in the second packing container can be moved out from second closed internal volume 214 under fluid connection state. As an example, when these components are moved out from second closed internal volume 214, manifold connector 124 can be communicated with patient interface connector 127 fluid via fluid line 109. As another example, fluid reservoir 106 can be fixed on the sleeve at the drive assembly housing that is included in the fluid injector. Then can perform fluid purge process in the manner as described about injection setting kit 200.

[0088]

[0066] Embodiments have been described with respect to exemplary applications related to fluid injectors. However, various other applications are within the scope of the present disclosure.

[0089] For example, other embodiments may include applications related to other medical components. A medical component set kit may include a first packaging container and a second packaging container. In this embodiment, the first packaging container may define a first enclosed internal volume including one or more first-stage medical components, and the second packaging container may define a second enclosed internal volume including one or more second-stage medical components. This embodiment may also include a connecting line having a first connecting line end and a second connecting line end. The first connecting line end may be connected to one or more of the one or more first-stage medical components within the first enclosed internal volume of the first packaging container. The second connecting line end may extend outside the first enclosed internal volume of the first packaging container. In one example, the second connecting line end may be within the second enclosed internal volume of the second packaging container. For example, in this example, the second connecting line end may be connected to one or more of the one or more second-stage medical components within the second enclosed internal volume of the second packaging container. In this medical component set kit embodiment, the first and second packaging containers may each define one or more openings and / or include a panel, as previously described.

[0090] In a medical component set kit embodiment, one or more first-stage medical components and one or more second-stage medical components can be components configured to be used in the same medical procedure. One or more first-stage medical components can be components configured to be set in place and utilized during the first stage of the medical procedure, while one or more second-stage medical components can be components configured to remain in a second, closed internal volume during the first stage of the medical procedure. For example, a first packaging container can be opened, and at least one of the one or more first-stage medical components can be appropriately positioned outside the internal volume of the first packaging container, while a second connecting line end remains connected to the one or more second-stage medical components within the second, closed internal volume. Then, actions related to the medical procedure can be performed, such as pre-procedure initialization actions or the first step in the medical procedure. After performing these actions related to the medical procedure, the second packaging container can then be opened and at least one of the one or more second-stage medical components can be appropriately positioned outside the internal volume of the second packaging container. Then, other actions related to the medical procedure, such as the first step, the second step, or any subsequent step, can be performed, for example, using at least one of the one or more second-stage medical components.

[0091] In a specific example, the medical component setting kit embodiment as described above can include blood flow reserve fraction (FFR:Fractional Flow Reserve) component setting kit.In an exemplary FFR component setting kit, the first closed internal volume of the first packaging container can include the first end of the guide wire, the first end of the signal line, and one or more of the proximal portion of the sensor delivery device. This exemplary FFR component setting kit can also include the second closed internal volume of the second packaging container, which has the second end of the guide wire, the second end of the signal line, and one or more of the distal portion with pressure sensor of the sensor delivery device. Guide wire, signal line and sensor delivery device (for example, if each is included in a specific embodiment) can extend from the first internal volume to the second internal volume. This exemplary FFR component setting kit can allow opening the first packaging container, so that one or more of the first end of the guide wire, the first end of the signal line, and the proximal portion of the sensor delivery device can be prepared for FFR procedure, for example, by suitably constructing these components relative to the console to carry out. Once these one or more components have been removed and prepared, the second packaging container can be opened so that one or more of the second end of the guide wire, the second end of the signal wire, and the distal portion of the sensor delivery device having the pressure sensor can be inserted into the patient during the FFR procedure.

[0092] Figure 7A flow chart illustrating an embodiment of a method 600 of setting up an injection system is shown.

[0093] At step 610, open the first packing container. As an example, the first packing container mentioned in this method 600 can be identical or similar to the second packing container 210 described elsewhere in this article. When opening the first packing container, step 610 can include moving out a manifold connector from the first packing container. The manifold connector moving out from the first packing container can include the first manifold inlet, the second manifold inlet and the manifold outlet. The manifold outlet of the manifold connector moving out from the first packing container can be connected to one end of a fluid line. The other end of a fluid line can extend in the closed inner volume of the second packing container. In certain embodiments, the second packing container can encapsulate this closed inner volume, and the second packing container can include an orifice, and the other end of a fluid line extends in the closed inner volume through the orifice. In many cases, opening the first packing container at step 610 can include maintaining a sterile environment in the second packing container. As an example, the second packing container mentioned in this method 600 can be identical or similar to the first packing container 205 described elsewhere in this article.

[0094] In another embodiment, opening the first packaging container at step 610 may further include removing a flushing fluid line having a first flushing fluid line end and a second flushing fluid line end from the first packaging container. The first flushing fluid line end may be connected to the second manifold inlet. In this other embodiment, after opening the first packaging container, the second flushing fluid line end may be connected to a flushing fluid reservoir. After the second flushing fluid line end is connected to the flushing fluid reservoir, flushing fluid may be delivered along the flushing fluid line to a fluid collection receptacle within the enclosed interior volume of the second packaging container.

[0095] After opening the first packaging container, the first manifold inlet can be fluidly connected to the contrast fluid reservoir at step 620. The contrast fluid reservoir can define an interior reservoir volume including a first plunger.

[0096] At step 630 , after connecting the first manifold inlet to the contrast fluid reservoir, the contrast fluid may be delivered from the contrast fluid reservoir along a fluid line to a fluid collection receptacle within the enclosed interior volume of the second packaging container.

[0097] At step 640, after contrast fluid is delivered to the fluid collection receiver, the second packaging container can be opened.When opening the second packaging container, step 640 can comprise the other end, the fluid collection receiver and the patient interface connector that is communicated with the fluid line fluid that shift out from the second packaging container.The patient interface connector that shifts out from the second packaging container can comprise patient interface inlet, patient interface outlet and valve, and this valve is configured to selectively allow fluid to be communicated to the patient interface outlet by the patient interface connector from the patient interface inlet.For example, the patient interface outlet of patient interface connector can be fluidically connected to the fluid collection container in the sealed inner volume of the second packaging container before opening the second packaging container.

[0098] At step 650, after opening the second packaging container, the patient interface connector can be fluidically connected to the injection catheter. One or more fluids can be delivered to the injection catheter from the connected fluid reservoir. For example, after fluidically connecting the patient interface connector to the injection catheter, a contrast fluid can be delivered to the injection catheter from the contrast fluid reservoir along a fluid line.

[0099] Various non-limiting exemplary embodiments have been described. It should be understood that suitable alternatives are possible without departing from the scope of the examples described herein. These and other examples are within the scope of the appended claims.

Claims

1. An injection setting kit (200; 300; 400), including: A first packaging container (205) defining a first closed sterile interior volume (212), the first closed sterile interior volume comprising: 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 communicate from the patient interface inlet through the patient interface connector to the patient interface outlet; and ii. a fluid collection receptacle (250) fluidly connected to the patient interface outlet; a second packaging container (210) separate from the first packaging container, the second packaging container defining a second closed sterile interior volume (214), the second closed sterile interior volume including a manifold connector (124) having 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 connected to the patient interface inlet within the first closed sterile interior volume of the first packaging container, and the second fluid line end extends outside the first closed sterile interior volume of the first packaging container and is fluidly connected to the manifold outlet within the second closed sterile interior volume of the second packaging container; in: - the first packaging container and the second packaging container are removably coupled together at a common packaging area in which the first packaging container and the second packaging container engage, the first packaging container and the second packaging container comprising respective holes (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 interior volume, and (ii) the first fluid line end connected to the patient interface within the first closed sterile interior volume of the first packaging container; and - The fluid collection receptacle is configured to retain fluid output from the manifold outlet during an air purge process performed when the second packaging container is open and the first packaging container maintains its first closed sterile interior volume.

2. The injection setup kit of claim 1 , further comprising a flushing fluid line (230) having a first flushing fluid line end (228) and a second flushing fluid line end (234), and wherein The manifold connector includes a further manifold inlet (218), wherein the first flushing fluid line end is connected to the further manifold inlet within the second closed sterile interior volume (214) of the second packaging container (210).

3. The injection setting kit according to claim 1, wherein: The second closed sterile interior volume (214) of the second packaging container (210) further includes an air detection interface (239) located downstream of the manifold outlet (220), the air detection interface being configured to facilitate detecting the presence of air in the fluid line (109).

4. The injection setup kit according to claim 1, wherein: The second closed sterile interior volume (214) of the second packaging container (210) further includes a first fluid reservoir (106) defining a first interior reservoir volume (281), the first interior reservoir volume including a first plunger (108).

5. The injection setting kit according to claim 4, wherein: The second closed sterile interior volume (214) of the second packaging container (210) further includes a contrast fluid line (226), the contrast fluid line having a first contrast fluid line end (224) and a second contrast fluid line end (232), the first contrast fluid line end being connected to the manifold inlet (216) within the second closed sterile interior volume of the second packaging container, and the second contrast fluid line end being connected to the first fluid reservoir (106) within the second closed sterile interior volume of the second packaging container.

6. The injection setup kit according to claim 5, wherein: The second closed sterile interior volume (214) of the second packaging container (210) further includes a second fluid reservoir defining a second interior reservoir volume (281), the second interior reservoir volume including a second plunger.

7. The injection setup kit of claim 6, further comprising a flushing fluid line (230) having a first flushing fluid line end (228) and a second flushing fluid line end (234), and wherein The manifold connector includes a further manifold inlet (218), wherein the first flushing fluid line end is connected to the further manifold inlet within the second closed sterile interior volume (214) of the second packaging container (210), and the second flushing fluid line end (234) is connected to the second fluid reservoir within the second closed sterile interior volume (214) of the second packaging container (210).

8. The injection setup kit according to claim 1, wherein: The patient interface connector (127) includes a further patient interface outlet (258), and wherein the valve (259) of the patient interface connector is configured to selectively allow fluid to communicate from the patient interface inlet (256) to either the patient interface outlet (257) and the further patient interface outlet (258).

9. The injection setup kit according to claim 2, wherein: The manifold connector (124) includes a manifold valve (222) configured to move between a first manifold valve position in which the manifold valve blocks fluid communication from the manifold inlet (216) to the manifold outlet (220) and a second manifold valve position in which the manifold valve blocks fluid communication from the other manifold inlet (218) to the manifold outlet in response to a pressure change at the manifold connector.

10. The injection setup kit according to claim 1, wherein: The first packaging container (205) includes a panel (260), and the second packaging container (210) includes a panel (265), the panel (260) of the first packaging container is located on the area of ​​the first packaging container (205) where its hole (236a) is provided, and the panel (265) of the second packaging container is located on the area of ​​the second packaging container (210) where its hole (236b) is provided, and the panel (265) of the second packaging container is configured to be removably coupled to the panel (260) of the first packaging container.

11. The injection setup kit according to claim 10, wherein: The panel (265) of the second packaging container (210) includes a connecting element (270b) configured to be removably coupled to a corresponding connecting element (270a) provided by the panel (260) of the first packaging container (205).

12. A method of setting up an injection system using an injection setting kit (200; 300; 400) according to any one of claims 1 to 11, the method comprising the following steps: opening the first packaging container and removing a manifold connector from the first packaging container, wherein the manifold connector removed from the first packaging container comprises a first manifold inlet and a manifold outlet, and wherein the manifold outlet of the manifold connector removed from the first packaging container is connected to one end of a fluid line, another end of the fluid line extending within the enclosed interior volume of the second packaging container; After opening the first packaging container, fluidly connecting the first manifold inlet to a source of contrast fluid; After connecting the first manifold inlet to a contrast fluid source, delivering the contrast fluid along the fluid line from the contrast fluid source to a fluid collection receptacle within the enclosed interior volume of the second packaging container; after delivering the contrast fluid to the fluid collection receptacle, opening the second packaging container and removing the other end of the fluid line, the fluid collection receptacle, and the patient interface connector in fluid communication with the fluid line from the second packaging container; and After opening the second packaging container, the patient interface connector is fluidly connected to the injection catheter.

13. The method according to claim 12, wherein: The second packaging container encloses a closed interior volume and includes an aperture through which the other end of the fluid line extends into the closed interior volume, and wherein opening the first packaging container includes maintaining a sterile environment within the second packaging container.

14. The method according to claim 12, wherein: The manifold connector further includes a second manifold inlet, and wherein opening the first packaging container further includes removing a flushing fluid line from the first packaging container, the flushing fluid line having a first flushing fluid line end and a second flushing fluid line end, the first flushing fluid line end being connected to the second manifold inlet.

15. The method according to claim 14, further comprising the steps of: After opening the first packaging container, connecting the second flushing fluid line end to the flushing fluid reservoir; After connecting the second flush fluid line end to the flush fluid reservoir, delivering the flush fluid along the flush fluid line to a fluid collection receptacle within the enclosed interior volume of the second packaging container; and After fluidly connecting the patient interface connector to the injection catheter, contrast fluid is delivered along the fluid line from the contrast fluid source to the injection catheter.

16. The method according to claim 12, wherein: The patient interface connector includes a patient interface inlet, a patient interface outlet, and a valve configured to selectively allow fluid to communicate from the patient interface inlet through the patient interface connector to the patient interface outlet.

17. The method according to claim 16, wherein The patient interface outlet of the patient interface connector is fluidly connected to the fluid collection receptacle within the closed interior volume of the second packaging container.

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