Patient line air detection and reuse prevention

Abstract

A drug delivery line for use with a fluid injector system includes a fluid verification module configured to be in operative communication with a housing of the fluid injector system such that the fluid injector system can determine a status of the drug delivery line. The fluid verification module includes a body defining an inlet port, an outlet port, and a fluid passage extending from the inlet port to the outlet port; a first conduit portion connected to the inlet port; and a second conduit portion connected to the outlet port. The invention also discloses a fluid injector system.

Description

[0001] This application is a divisional application of the Chinese national phase application of PCT international patent application PCT / US2020 / 048993, with an application date of September 2, 2020. The application number of the Chinese national phase application is 202080060905.1. Technical Field

[0002] The present disclosure relates to fluid injector systems, and more particularly to fluid injector systems including administration line assemblies having features that increase patient safety, such as air detection and / or reuse prevention features. Background Art

[0003] In many medical diagnostic and therapeutic procedures, a medical practitioner (e.g., a physician) infuses a patient with one or more medical fluids. In recent years, a variety of medical fluid delivery systems have been developed for pressurized infusion of fluids such as contrast solutions (often referred to simply as "contrast"), irrigants (e.g., saline), and other medical fluids for use in procedures such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other molecular imaging procedures.

[0004] In some infusion procedures, a medical practitioner places a catheter or needle into a patient's vein or artery. The catheter or needle is connected to a medical fluid delivery system via a tubing set. Tubing sets typically include features in their design that protect the fluid source from blood-borne contamination (e.g., check valves). Such tubing sets are designed and recommended for a limited number of uses, typically one time, to prevent cross-contamination of the rest of the system between patients. However, due to accidental or purposeful misuse, the tubing set may be used more than the recommended number of uses.

[0005] Another limitation of conventional patient lines is that priming is often awkward and can be unsanitary. Priming the patient line with fluid is accomplished by injecting the fluid through the patient line prior to connecting the line to the patient, which is necessary to prevent air from being injected into the patient. In order to capture and contain fluid expelled from the patient line during priming, practitioners typically hold the end of the patient line over a waste container or cloth. However, this practice has the potential to result in contamination of the sterile end of the line. Summary of the invention

[0006] In view of the above, there is a need for patient lines and fluid delivery systems that enforce a recommended replacement schedule for patient lines. Additionally, there is a need for patient lines having features that facilitate hygienic perfusion. In this context, aspects or examples of the present disclosure relate to a dosing line for use with a fluid injector system. In some aspects or examples, the dosing line includes a fluid verification module that is configured to be operably connected to a housing of the fluid injector system so that the fluid injector system can determine the status of the dosing line. The fluid verification module includes a body defining an inlet port, an outlet port, and a fluid passage extending from the inlet port to the outlet port; a first tubing portion connected to the inlet port; and a second tubing portion connected to the outlet port.

[0007] In some aspects or examples, the first tubing portion includes a first inlet connector configured to be connected to a first fluid reservoir of a fluid injector system, and a second inlet connector configured to be connected to a second fluid reservoir of the fluid injector system. The first inlet connector is configured to be connected to the second inlet connector during storage or transportation of the administration line.

[0008] In some aspects or examples, the first tubing portion includes an inlet connector configured to connect to an intermediate tubing set in fluid communication with at least one fluid reservoir of the fluid injector system. The inlet connector is configured to connect to the body of the fluid verification module during storage or transportation of the administration line.

[0009] In some aspects or examples, the body further defines an irrigation port, and the second tubing portion includes an outlet connector configured to connect to the irrigation port during storage or transportation of the administration line.

[0010] In some aspects or examples, the priming port is in fluid communication with a priming lumen, and the priming lumen is configured to receive and retain priming fluid from the outlet connector during a priming operation of the administration line.

[0011] In some aspects or examples, the administration line further comprises at least one sheet material disposed within the perfusion chamber. The at least one sheet material comprises a first sheet material having a marking and a second sheet material, wherein when the second sheet material is in contact with the perfusion fluid, the second sheet material transitions from an opaque state to an at least partially translucent state. When the second sheet material is in the opaque state, the marking on the first sheet material is obscured by the second sheet material. When the second sheet material is in the translucent state, the marking on the first sheet material is visible through the window in the body.

[0012] In some aspects or examples, the administration line further comprises at least one sheet of material disposed within the perfusion chamber. The at least one sheet of material is configured to change resistance when in contact with the perfusion fluid. When the fluid verification module is mounted to the housing of the fluid injector system, the at least one sheet of material is configured to interface with at least one probe of the fluid injector system to measure the resistance of the at least one sheet of material.

[0013] In some aspects or examples, the body of the fluid verification module further includes a capillary channel in fluid communication with the perfusion chamber and configured to draw at least a portion of the perfusion fluid by capillary action.

[0014] In some aspects or examples, at least a portion of the body of the fluid verification module is configured to act as a lens to display light emitted from a light source of the fluid injector system.

[0015] In some aspects or examples, the body of the fluid verification module includes one or more engagement features configured to secure the fluid verification module to the housing of the fluid injector system.

[0016] In some aspects or examples, the fluid channel is at least partially transparent such that an imaging device of the housing can determine whether fluid is present in the fluid channel.

[0017] In some aspects or examples, the fluid passage is flexible and is configured to interface with a strain gauge of the housing such that the strain gauge can determine fluid pressure in the administration line.

[0018] In some aspects or examples, the administration line further comprises at least one of: an inlet check valve associated with the inlet port, and an outlet check valve associated with the outlet port. At least one of the inlet check valve and the outlet check valve prohibits fluid from flowing in an upstream direction from the second pipeline portion to the first pipeline portion.

[0019] Other aspects or examples of the present disclosure relate to a fluid injector system that is configured to perform an injection process in conjunction with a diagnostic imaging process. The fluid injector system includes a dosing line that includes a fluid verification module. The fluid verification module includes a body that defines an inlet port, an outlet port, and a fluid channel extending from the inlet port to the outlet port. The dosing line also includes a first pipeline portion connected to the inlet port and a second pipeline portion connected to the outlet port. The fluid injector system also includes a controller that is programmed or configured to determine the state of the dosing line.

[0020] In some aspects or examples, the first tubing portion includes a first inlet connector and a second inlet connector. The first inlet connector is configured to be connected to a first fluid reservoir of a fluid injector system. The second inlet connector is configured to be connected to a second fluid reservoir of the fluid injector system. The first inlet connector is configured to be connected to the second inlet connector during storage or transportation of the administration line.

[0021] In some aspects or examples, the first tubing portion includes an inlet connector configured to connect to an intermediate tubing set in fluid communication with at least one fluid reservoir of the fluid injector system. The inlet connector is configured to connect to the body of the fluid verification module during storage or transportation of the administration line.

[0022] In some aspects or examples, the body of the fluid verification module further defines a priming port, and the second tubing portion includes an outlet connector configured to connect to the priming port during storage or transportation of the administration line.

[0023] In some aspects or examples, the priming port is in fluid communication with a priming lumen, and the priming lumen is configured to receive and retain priming fluid from the outlet connector during a priming operation of the administration line.

[0024] In some aspects or examples, the fluid injector system further comprises at least one sheet material disposed within the perfusion chamber. The at least one sheet material comprises a first sheet material having a marking and a second sheet material. When the second sheet material contacts the perfusion fluid, the second sheet material transitions from an opaque state to an at least partially translucent state. When the second sheet material is in the opaque state, the marking on the first sheet material is obscured by the second sheet material. When the second sheet material is in the translucent state, the marking on the first sheet material is visible through the window in the body.

[0025] In some aspects or examples, the fluid injector system further comprises at least one probe for measuring resistance in communication with the controller and at least one sheet of material disposed within the perfusion chamber. The at least one sheet of material is configured to change resistance when in contact with the perfusion fluid. When the fluid verification module is mounted to the housing of the fluid injector system, the at least one sheet of material is configured to interface with the at least one probe so that the resistance of the at least one sheet of material can be determined by the controller.

[0026] In some aspects or examples, the controller is programmed or configured to inhibit performance of the injection procedure in response to determining, via the at least one probe, that the at least one sheet of material has been previously contacted by the irrigating fluid.

[0027] In some aspects or examples, the fluid injector system further includes a light source in communication with the controller. At least a portion of the body of the fluid verification module is configured to act as a lens to display light emitted by the controller from the light source.

[0028] In some aspects or examples, the fluid injector system further comprises an imaging device in communication with the controller. The fluid channel is at least partially transparent so that the controller can determine whether fluid is present in the fluid channel through the imaging device.

[0029] In some aspects or examples, the controller is programmed or configured to stop performance of the fluid injection procedure in response to detecting air in the fluid passage via the imaging device.

[0030] In some aspects or examples, the fluid injector system further comprises a strain gauge in communication with the controller. The fluid channel is flexible and configured to interface with the strain gauge so that the controller can determine the fluid pressure in the drug delivery line through the strain gauge.

[0031] In some aspects or examples, the fluid injector system further comprises at least one of: an inlet check valve associated with the inlet port, and an outlet check valve associated with the outlet port. At least one of the inlet check valve and the outlet check valve prohibits fluid from flowing in an upstream direction from the second pipeline portion to the first pipeline portion.

[0032] Other aspects and examples of the disclosure are set forth in the following numbered clauses.

[0033] Item 1. A drug administration line for use with a fluid injector system, the drug administration line comprising: a fluid verification module, the fluid verification module being configured to be operably connected to a housing of the fluid injector system so that the fluid injector system can determine the status of the drug administration line, the fluid verification module comprising: a body defining an inlet port, an outlet port, and a fluid channel extending from the inlet port to the outlet port; a first pipeline portion connected to the inlet port; and a second pipeline portion connected to the outlet port.

[0034] Item 2. A drug delivery line according to Item 1, wherein the first line portion comprises: a first inlet connector, the first inlet connector being configured to be connected to a first fluid reservoir of the fluid injector system; and a second inlet connector, the second inlet connector being configured to be connected to a second fluid reservoir of the fluid injector system, wherein the first inlet connector is configured to be connected to the second inlet connector during storage or transportation of the drug delivery line.

[0035] Clause 3. A drug administration line according to clause 1 or 2, wherein the first tubing portion comprises: an inlet connector configured to be connected to an intermediate tubing kit that is fluidically connected to at least one fluid reservoir of the fluid injector system, wherein the inlet connector is configured to be connected to the body of the fluid verification module during storage or transportation of the drug administration line.

[0036] Clause 4. The administration line of any one of clauses 1 to 3, wherein the body further defines an irrigation port, and wherein the second tubing portion includes an outlet connector configured to be connected to the irrigation port during storage or transportation of the administration line.

[0037] Clause 5. The administration line of any one of clauses 1 to 4, wherein the irrigation port is in fluid communication with an irrigation lumen, and wherein the irrigation lumen is configured to receive and retain irrigation fluid from the outlet connector during an irrigation operation of the administration line.

[0038] Clause 6. The drug delivery line according to any one of clauses 1 to 5 further includes at least one sheet material disposed in the perfusion chamber, the at least one sheet material comprising: a first sheet material having a mark; and a second sheet material, wherein when the second sheet material comes into contact with the perfusion fluid, the second sheet material changes from an opaque state to an at least partially translucent state, wherein when the second sheet material is in the opaque state, the mark on the first sheet material is obscured by the second sheet material, and wherein when the second sheet material is in the translucent state, the mark on the first sheet material is visible through the window in the body.

[0039] Clause 7. The drug delivery line according to any one of clauses 1 to 6, further comprising at least one sheet material disposed within the perfusion chamber, wherein the at least one sheet material is configured to change resistance when in contact with the perfusion fluid, and wherein when the fluid verification module is mounted to the housing of the fluid injector system, the at least one sheet material is configured to connect to at least one probe of the fluid injector system for measuring the resistance of the at least one sheet material.

[0040] Clause 8. The administration line of any one of clauses 1 to 7, wherein the body of the fluid verification module further comprises a capillary channel in fluid communication with the perfusion chamber and configured to draw at least a portion of the perfusion fluid by capillary action.

[0041] Clause 9. The drug administration line of any of clauses 1 to 8, wherein at least a portion of the body of the fluid verification module is configured to act as a lens to display light emitted from a light source of the fluid injector system.

[0042] Clause 10. The administration line of any one of clauses 1 to 9, wherein the body of the fluid verification module comprises one or more engagement features configured for securing the fluid verification module to the housing of the fluid injector system.

[0043] Clause 11. The drug delivery line of any one of Clauses 1 to 10, wherein the fluid passageway is at least partially transparent such that an imaging device of the housing can determine whether fluid is present in the fluid passageway.

[0044] Clause 12. The drug delivery line of any one of clauses 1 to 11, wherein the fluid passageway is flexible and configured to interface with a strain gauge of the housing such that the strain gauge can determine fluid pressure in the drug delivery line.

[0045] Clause 13. The drug delivery line according to any one of clauses 1 to 12 further comprises at least one of: an inlet check valve associated with the inlet port; and an outlet check valve associated with the outlet port, wherein at least one of the inlet check valve and the outlet check valve prohibits fluid from flowing in an upstream direction from the second pipeline portion to the first pipeline portion.

[0046] Item 14. A fluid injector system configured to perform an injection process in conjunction with a diagnostic imaging process, the fluid injector system comprising: a drug administration line, comprising: a fluid verification module, the fluid verification module comprising a body defining an inlet port, an outlet port, and a fluid channel extending from the inlet port to the outlet port; a first pipeline portion connected to the inlet port; and a second pipeline portion connected to the outlet port; a controller programmed or configured to determine a status of the drug administration line.

[0047] Item 15. A fluid injector system according to Item 14, wherein the first pipeline portion includes: a first inlet connector, which is configured to be connected to a first fluid reservoir of the fluid injector system; and a second inlet connector, which is configured to be connected to a second fluid reservoir of the fluid injector system, wherein the first inlet connector is configured to be connected to the second inlet connector during storage or transportation of the administration pipeline.

[0048] Clause 16. A fluid injector system according to clause 14 or 15, wherein the first tubing portion comprises: an inlet connector configured to be connected to an intermediate tubing kit that is fluidically connected to at least one fluid reservoir of the fluid injector system, wherein the inlet connector is configured to be connected to the body of the fluid verification module during storage or transportation of the administration line.

[0049] Clause 17. A fluid injector system according to any one of clauses 14 to 16, wherein the body of the fluid verification module also defines an infusion port, and wherein the second tubing portion includes an outlet connector configured to be connected to the infusion port during storage or transportation of the administration line.

[0050] Clause 18. The fluid injector system of any one of clauses 14 to 17, wherein the irrigation port is in fluid communication with an irrigation lumen, and wherein the irrigation lumen is configured to receive and retain irrigation fluid from the outlet connector during an irrigation operation of the administration line.

[0051] Clause 19. A fluid injector system according to any one of Clauses 14 to 18, further comprising at least one sheet material disposed within the infusion chamber, the at least one sheet material comprising: a first sheet material having a mark; and a second sheet material, wherein when the second sheet material comes into contact with the infusion fluid, the second sheet material changes from an opaque state to an at least partially translucent state, wherein when the second sheet material is in the opaque state, the mark on the first sheet material is obscured by the second sheet material, and wherein when the second sheet material is in the translucent state, the mark on the first sheet material is visible through a window in the body.

[0052] Clause 20. The fluid injector system according to any one of clauses 14 to 19, further comprising: at least one probe for measuring resistance in communication with the controller; and at least one sheet material disposed within the perfusion chamber, wherein the at least one sheet material is configured to change resistance when in contact with the perfusion fluid, and wherein when the fluid verification module is mounted to the housing of the fluid injector system, the at least one sheet material is configured to interface with the at least one probe so that the resistance of the at least one sheet material can be determined by the controller.

[0053] Clause 21. A fluid injector system according to any one of clauses 14 to 20, wherein the controller is programmed or configured to inhibit execution of an injection process in response to determining via the at least one probe that the at least one sheet of material has previously been contacted by the infusion fluid.

[0054] Clause 22. The fluid injector system of any one of clauses 14 to 21, further comprising a light source in communication with the controller, wherein at least a portion of the body of the fluid verification module is configured to act as a lens to display light emitted from the light source by the controller.

[0055] Clause 23. The fluid injector system of any one of clauses 14 to 22, further comprising an imaging device in communication with the controller, wherein the fluid channel is at least partially transparent so that the controller can determine whether fluid is present in the fluid channel via the imaging device.

[0056] Clause 24. The fluid injector system of any of Clauses 14 to 23, wherein the controller is programmed or configured to cease performance of a fluid injection procedure in response to detecting air in the fluid channel via the imaging device.

[0057] Clause 25. The fluid injector system according to any one of Clauses 14 to 24, further comprising a strain gauge in communication with the controller, wherein the fluid channel is flexible and configured to interface with the strain gauge so that the controller can determine the fluid pressure in the drug delivery line through the strain gauge.

[0058] Clause 26. A fluid injector system according to any one of Clauses 14 to 25, further comprising at least one of: an inlet check valve associated with the inlet port; and an outlet check valve associated with the outlet port, wherein at least one of the inlet check valve and the outlet check valve prohibits fluid from flowing in an upstream direction from the second pipeline portion to the first pipeline portion.

[0059] These and other features and characteristics of the drug delivery line, fluid injector system, and the method of operation and function and economy of manufacture of the related structural elements and combinations of parts will become more apparent after considering the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification. It should be expressly understood, however, that the drawings are for purposes of illustration and description only. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 is a perspective view of a fluid injector system according to one aspect or example of the present disclosure;

[0061] Figure 2 According to one aspect or example of the present disclosure, a patient administration line is provided. Figure 1 A top view of a fluid injector system;

[0062] Figure 3 According to another aspect or example of the present disclosure, a patient administration line is provided. Figure 1 A top view of a fluid injector system;

[0063] Figure 4 yes Figure 2 A top view of a patient administration line shown in a storage or transport position;

[0064] Figure 5 yes Figure 3 Top view of a patient dosing line shown in a storage or transport position.

[0065] Figure 6 According to another aspect or example of the present disclosure, a patient administration line is provided. Figure 1 A top view of a fluid injector system;

[0066] Figure 7 yes Figure 2 A top view of a fluid injector system, wherein a drug delivery line is mounted on a housing of the fluid injector;

[0067] Figure 8 yes Figure 2 A top view of a fluid injector system of FIG. 1 with a drug delivery line in a position for connection to a patient;

[0068] Fig. 9 yes Figure 1 A detailed view of a mounting flange of a fluid injector system;

[0069] Fig.10 is a schematic diagram of the interior of a fluid verification module of a drug delivery line according to one aspect or example of the present disclosure;

[0070] Fig.11 is an exploded view of a fluid verification module of a drug delivery line according to one aspect or example of the present disclosure;

[0071] Fig.12 yes Fig.11 A front view of a fluid verification module shown prior to priming;

[0072] Fig.13 yes Fig.11 A front view of a fluid verification module shown after priming;

[0073] Fig.14 is a flow chart of a method of preparing a fluid injector system to perform an injection procedure according to one aspect or example of the present disclosure; and

[0074] Fig.15 is a schematic diagram of an electronic control system for a fluid injector system according to one aspect or example of the present disclosure. DETAILED DESCRIPTION

[0075] For purposes of the description below, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall relate to the present disclosure as it is oriented in the accompanying drawings. When used with respect to a syringe of a multi-patient disposable set, the term "proximal" refers to the portion of the syringe closest to the piston for delivering fluid from the syringe.

[0076] Spatial or directional terms, such as "left", "right", "inner", "outer", "upper", "lower", etc., are not to be considered limiting as the disclosure may assume various alternative orientations.

[0077] In all cases, all numbers used in the specification and claims are to be understood as modified by the term “about.” The terms “approximately,” “about,” and “substantially” refer to a range of plus or minus ten percent of the stated value.

[0078] As used herein, the term "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" refers to any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more individual A; or one or more individual B; or one or more individual C; or one or more A and one or more B; or one or more A and one or more C; or one or more B and one or more C; or one or more all of A, B, and C. Similarly, as used herein, the term "at least two" is synonymous with "two or more." For example, the phrase "at least two of D, E, and F" means any combination of any two or more of D, E, and F. For example, "at least two of D, E, and F" includes one or more D and one or more E; or one or more D and one or more F; or one or more E and one or more F; or one or more all of D, E, and F.

[0079] It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely exemplary examples of the present disclosure. Therefore, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered as limiting.

[0080] When used with respect to a component of a fluid injector system (e.g., a fluid reservoir, a syringe, or a fluid line), the term "distal" refers to the portion of the component that is closest to the patient. When used with respect to a component of a fluid injector system (e.g., a fluid reservoir, a syringe, or a fluid line), the term "proximal" refers to the portion of the component that is closest to the injector of the fluid injector system (i.e., the portion of the component that is farthest from the patient). When used with respect to a component of a fluid injector system (e.g., a fluid reservoir, a syringe, or a fluid line), the term "upstream" refers to a direction away from the patient and toward the injector of the fluid injector system. For example, if a first component is referred to as "upstream" of a second component, the first component is closer to the injector than the second component. When used with respect to a component of a fluid injector system (e.g., a fluid reservoir, a syringe, or a fluid line), the term "downstream" refers to a direction toward the patient and away from the injector of the fluid injector system. For example, if a first component is referred to as "downstream" of a second component, the first component is closer to the patient than the second component.

[0081] Although mainly in The present disclosure is described in the context of the Stellant CT infusion system, but it will be apparent to one of ordinary skill in the art that the present disclosure is applicable to various infusion systems including their associated disposables (e.g., syringes, tubing, etc.). Examples of such infusion systems include the Stellant CT infusion system provided by Bayer Healthcare GmbH. Salient CT injection system, Stellant FLEX CT injection system, Centargo CT injection system, MRXperion MR Injection System and Mark 7 Arterion Infusion System.

[0082] Referring to the drawings, wherein like reference characters refer to like parts throughout the several views thereof, the present disclosure generally relates to fluid injector systems, drug delivery lines, and methods of operating the same.

[0083] First reference Figure 1 An example of a fluid injector system 1000 according to the present disclosure includes a housing 15 and at least one fluid reservoir, such as at least one syringe 12. The fluid injector system 1000 also includes a piston 13 associated with each syringe 12, which drives a plunger 14 within the barrel of the syringe 12. At least one syringe 12 is typically adapted to be releasably connected to the housing 15 at the injector port. At least one syringe 12 can be oriented in any manner, such as upright, inverted, or positioned at any angle. The fluid injector system 1000 is typically configured to deliver at least one medical fluid F to a patient during an injection process. The fluid injector system 1000 is configured to releasably receive at least one syringe 12, which will be filled with at least one medical fluid F, such as an imaging contrast medium, a saline solution, or any desired medical fluid. Each syringe 12 can be filled with a different medical fluid F. As shown, the fluid injector system 1000 can be a multi-syringe injector, wherein several syringes 12 can be oriented side by side or in another spatial relationship and are separately actuated by respective pistons associated with the injector system 1000.

[0084] Continue to refer Figure 1, the fluid injector system 1000 can be used during a medical procedure to inject at least one medical fluid F into the vascular system of a patient by driving a plunger 14 associated with at least one syringe 12 with at least one piston 13. The at least one piston 13 can reciprocate on the plunger 14. Once engaged, the at least one piston 13 can move the plunger 14 toward the proximal end of the at least one syringe 12 to draw the medical fluid F from a bulk fluid reservoir (not shown) such as a vial, bottle, or IV bag into the at least one syringe 12. The at least one piston 13 can further move the plunger 14 toward the distal end 19 of the at least one syringe 12 to discharge the fluid F from the at least one syringe 12 out of the patient line and into the patient at a vascular access location.

[0085] The housing 15 of the fluid injector system 1000 may contain components of the electronic control device 900 (see Figure 2 , 3 , 6 to 8 and 15), for example, a controller (such as at least one processor programmed or configured to receive, store and perform instructions for actuating the fluid injector system 1000). The controller 900 can, for example, be programmed or configured to perform one or more injection processes and / or one or more perfusion processes.

[0086] Further details and examples of suitable non-limiting power injector systems including injectors, controllers, air detectors, and fluid path kits are described in the following patents: U.S. Patent No. 5,383,858; U.S. Patent No. 7,553,294; U.S. Patent No. 7,666,169; U.S. Patent No. 8,945,051; U.S. Patent No. 10,022,493; and U.S. Patent No. 10,507,319, the disclosures of which are incorporated herein by reference in their entireties.

[0087] Figure 2 and Figure 3 A fluid injector system 1000 is shown that includes a patient dosing line assembly 2000 (hereinafter "dosing line 2000") in accordance with various aspects and examples of the present disclosure. The dosing line 2000 includes a fluid verification module 2100 that can perform various functions that will be discussed in more detail herein, but generally involves priming the dosing line 2000, forcing replacement of the dosing line 2000 at recommended intervals, displaying alerts to a user, and other functions. In addition, the fluid verification module 2100 may include features to prevent contamination of upstream components, such as one or more integrated check valves (see Fig.10). The fluid verification module 2100 includes a body 2110, which can be an at least partially hollow structure defining various ports, channels, chambers, etc., which will be described in detail herein. As shown in the figures, the shape of the body 2110 can be cylindrical, although any suitable shape can be used.

[0088] The inlet port 2120 and the outlet port 2130 can be defined in the body 2110 of the fluid verification module 2100. The inlet port 2120 is configured to receive a first tubing portion 2140, which extends proximally toward at least one syringe 12. The outlet port 2130 is configured to receive a second tubing portion 2150, which extends distally to ultimately connect to a needle or catheter (not shown) inserted into a patient. The first tubing portion 2140 and the second tubing portion 2150 can be permanently and irreversibly attached to the body 2110 of the fluid verification module 2100 (e.g., by solvent welding) to prevent the first tubing portion 2140 and the second tubing portion 2150 from being reused with different fluid verification modules 2100. However, it is within the scope of the present disclosure that the first tubing portion 2120 and the second tubing portion 2150 can be removably attached to the body 2110 (e.g., by a barbed connector, a Luer connector, a bayonet connector, etc.). In some aspects or examples, the inlet port 2120 or a portion of the first line portion 2140 adjacent to the inlet port 2120 may include a one-way valve (e.g., a check valve) to prevent fluid from flowing toward the inlet port 2120. Similarly, the outlet port 2130 or a portion of the second line portion 2150 adjacent to the outlet port 2130 may include a one-way valve (e.g., a check valve) to prevent fluid from flowing toward the inlet port 2120. Fig.10 As described, one-way valves may also be integrated into the inlet port 2120 and the outlet port 2130 .

[0089] Specific reference Figure 2In the aspect or example of the administration line 2000 shown in FIG, a first tubing section 2140 includes a first inlet connector 2142 and a second inlet connector 2144, each of which is configured to be directly or indirectly connected to one of at least one syringe 12. The first tubing section 2140 includes a Y-shaped or T-shaped connector 2146, which branches the first tubing section 2140 into two fluid paths extending to the first inlet connector 2142 and the second inlet connector 2144, respectively. The first tubing section 2140 may also include a one-way valve 2148 (e.g., a check valve) between the Y-shaped or T-shaped connector 2146 and the first inlet connector 2142 to prevent fluid from flowing back into the syringe 12 connected to the first inlet connector 2142. In particular, the one-way valve 2148 prevents contrast agent from flowing back into the syringe 12 containing saline under high injection pressure. The second tubing section 2150 includes an outlet connector 2152, which is configured to be directly or indirectly connected to a needle or catheter (not shown) inserted into the patient's body. Each of the first inlet fitting 2142, the second inlet fitting 2144, and the outlet fitting 2152 can be a Luer connector, a hose barb, a bayonet connector, or any other type of connector for establishing fluid communication between components. Figure 2 The aspects or examples of the fluid administration line 2000 shown in the figure can be used as a disposable line, which must be completely replaced after the fluid injector system 1000 performs an injection process. Fig.14 As described, the controller 900 can force replacement of the administration line 2000 after the injection process.

[0090] Reference now Figure 4 , Figure 2 The aspects or examples of the dosing line 2000 shown in are illustrated in a transport or storage state. To prevent contaminants from entering the dosing line 2000 prior to use, the first inlet connector 2142, the second inlet connector 2144, and the outlet connector 2152 can be covered to prevent exposure to the surrounding environment. In some aspects or examples, one or more of the first inlet connector 2142, the second inlet connector 2144, and the outlet connector 2152 can be equipped with a dust cover. In some aspects or examples, one or more of the first inlet connector 2142, the second inlet connector 2144, and the outlet connector 2152 can be assembled into a port in the body 2110. For example, as Figure 4As shown, each of the first inlet connector 2142 and the second inlet connector 2144 can be fitted to a common dust cover 2160, and the third connection port 2152 is assembled to the perfusion port 2154 in the body 2110 of the fluid verification module 2100. With this arrangement, only a single disposable piece (i.e., the dust cover 2160) is required to seal the drug delivery line 2000 from contamination by the surrounding environment. Other arrangements are also understood to be within the scope of the present disclosure. For example, the outlet connector 2152 can be assembled into the dust cover 2160 or a separate dust cover. Optionally, the first inlet connector 2142 and the second inlet connector 2144 can be assembled into the port in the fluid verification module 2100.

[0091] Continue to refer Figure 4 The dosing line 2000 may be prepared for an injection procedure by removing the dust cap 2160 from the first inlet connector 2142 and the second inlet connector 2144. Figure 2 As shown, the first inlet connector 2142 and the second inlet connector 2144 can then be respectively connected to one or more syringes 12. After the priming operation, the outlet connector 2152 can be removed from the priming port 2154 of the fluid verification module 2100 and connected to a catheter, needle, etc. (not shown) for insertion into the patient.

[0092] Now specific reference Figure 3 In the illustrated aspects or examples of the administration line 2000, the first tubing portion 2140 includes an inlet connector 2142 configured to be connected to the intermediate tubing kit 1200, and the second tubing portion 2150 includes an outlet connector 2152 configured to be connected to a needle or catheter (not shown) inserted into the patient's body. The intermediate tubing kit 1200 can in turn be connected to at least one syringe 12. In particular, the intermediate tubing kit 1200 may include a first inlet connector 1210 configured to be connected to a first one of the syringes 12, a second inlet connector 1220 configured to be connected to a second one of the syringes 12, and an outlet connector 1230 configured to be connected to the first tubing portion 2140 of the administration line 2000. In some aspects and examples, the intermediate tubing kit 1200 may include one or more one-way valves (e.g., check valves, Figure 3 ), the one-way valve is positioned and oriented to prevent fluid from flowing back into various components of the fluid injector system 1000 or various components associated with the fluid injector system 1000, such as one or more syringes 12.

[0093] Each of the inlet connector 2142 and the outlet connector 2152 of the drug delivery line 2000 can be a Luer connector, a hose barb, a bayonet connector, or any other type of connector for establishing fluid communication between components. In particular, the inlet connector 2142 can be a multi-shielded connector that includes a recessed port to prevent accidental contact contamination when connecting between the drug delivery line 2000 and the intermediate tubing kit 1200. Similarly, each of the first inlet connector 1210 and the second inlet connector 1220 of the intermediate tubing kit 1200 can be a Luer connector, a hose barb, a bayonet connector, or any other type of connector for establishing fluid communication between components. The outlet connector 1230 can be a multi-shielded connector that prevents accidental contact contamination between the drug delivery line 2000 and the intermediate tubing kit 1200.

[0094] Figure 3 The aspects or examples of the fluid administration line 2000 shown can be used with a multi-patient intermediate circuit kit 1200. That is, the intermediate circuit kit 1200 can be used for multiple injection protocols and / or patients, such as a predetermined number of injection procedures and / or patients performed by the fluid injector system 1000. The administration line 2000 can be replaced after each injection procedure, but the backflow prevention feature of the administration line 2000 allows the multi-patient intermediate circuit kit 1200 to be reused without the risk of cross contamination. As described herein in conjunction with Fig.14 As described, the controller 900 can force replacement of the administration line 2000 after the injection process.

[0095] Reference now Figure 5 , Figure 3 The aspects or examples of the administration line 2000 shown in the figure are illustrated in a transport or storage state. To prevent contaminants from entering the administration line 2000, the inlet connector 2142 and the outlet connector 2152 can be covered to prevent exposure to the surrounding environment. In some aspects or examples, the inlet connector 2142 can be assembled into the blind port 2156, and the outlet connector 2152 can be assembled into the perfusion port 2154 in the body 2110. In other aspects or examples, one or both of the inlet connector 2142 and the outlet connector 2152 can be equipped with a separate dust cover or a common dust cover, similar to Figure 4 In the illustrated aspect or example, the first inlet connector 2142 and the second inlet connector 2144 are assembled to the dust cover 2160. By removing the inlet connector 2142 from the blind port 2156, the administration line 2000 can be prepared for the injection process. Figure 3As shown, the first inlet connector 2142 can then be connected to one or more syringes 12 via the multi-patient intermediate tubing kit 1200. After the priming operation is completed, the outlet connector 2152 can be removed from the priming port 2154 of the fluid verification module 2100 and connected to a catheter, needle, etc. (not shown) for insertion into a vascular access site of the patient.

[0096] Reference now Figure 6 , another aspect or example of the fluid injector system 1000 is shown. Figure 6 The aspects or examples shown are similar to Figure 3 The illustrated aspect or example has an expanded intermediate tubing set 1200. Figure 6 Within the scope of the specific components of the aspects shown, it should be understood that these components are Figure 3 Similar parts of the aspects shown are the same or similar. Figure 6 In the illustrated aspect or example, the intermediate tubing kit 1200 includes one or more fluid connectors 1240, such as bottle spikes, which are configured to be in fluid communication with a fluid reservoir (not shown), such as a bottle, vial, container, bag, pouch, etc. The intermediate tubing kit 1200 may also include one or more Y-shaped or T-shaped connectors 1242 and one or more one-way valves 1244, 1246 (e.g., check valves) to define a flow path and flow direction between the first inlet connector 1210, the second inlet connector 1220, the outlet connector 1230, and the fluid connector 1240.

[0097] Continue to refer Figure 6 In some aspects or examples, the drug administration line 2000 can include an inlet check valve 2141 (e.g., a check valve) in the first tubing portion 2140 to prevent the fluid from flowing toward the inlet connector 2142. Similarly, the drug administration line 2000 can include an outlet check valve 2151 (e.g., a check valve) in the second tubing portion 2150 to prevent the fluid from flowing toward the inlet connector 2142. The inlet check valve 2141 and the outlet check valve 2151 can be used alternatively or in addition to the check valves formed in the inlet port 2120 and the outlet port 2130, such as in combination. Figure 2 and 3 described.

[0098] Reference again Figure 1-3 The housing 15 of the fluid injector system 1000 may include a mounting flange and a control interface structure 16 (hereinafter referred to as "mounting flange 16") for holding the fluid verification module 2100. The mounting flange 16 allows the housing 15 of the fluid injector system 1000 to be operably connected to the fluid verification module 2100, so that the housing 15 can interact with the fluid verification module 2100 to determine the status of the drug delivery line 2000. Figure 7 and 8 Shows Figure 2 The fluid injector system 1000 of the present invention, wherein the fluid verification module 2100 is attached to the mounting flange 16, and wherein the first inlet connector 2142 and the second inlet connector 2144 are connected to the syringe 12, respectively. Figure 7 In FIG. 2 , the outlet connector 2152 is attached to the priming port 2154 of the fluid verification module 2100 so that the dosing line 2000 is ready to be primed or is in the process of being primed. Figure 8 , the outlet connector 2152 is detached from the priming port 2154 of the fluid verification module 2100, such that the administration line 2000 is ready for connection to a needle, catheter, etc. (not shown), and ultimately to a vascular access site in the patient.

[0099] Reference now Fig. 9 , the mounting flange 16 may include one or more engagement features 162 on the housing 15 of the fluid injector system 1000, the engagement features being configured to interface with the body 2110 of the fluid verification module 2100. The one or more engagement features 162 may include corresponding engagement features 2113 (see Fig.11 ) is connected to the housing 15, grooves, internal or external threads, channels or other features. One or more engagement features 162 may include sensors or the like to verify that a corresponding engagement feature 2113 of the fluid verification module 2100 is connected to the mounting flange 16. If the controller 900 determines based on the sensors in the one or more engagement features 162 that the fluid verification module 2100 is not properly connected to the housing 15, that the dosing line 2000 has been previously used for an injection process, or if the dosing line 2000 is not properly primed, the controller 900 may prohibit the execution of the injection process.

[0100] The mounting flange 16 may also include one or more sensors, lights, and / or communication devices for interfacing with the fluid verification module 2100. Fig. 9 In the aspect or example shown, the mounting flange 16 includes a light source 164 in the form of an LED ring, two probes 166 for measuring electrical characteristics, a strain gauge 168 , and at least one imaging device 169 .

[0101] The light source 164 can be directed through the body 2110 of the fluid verification module 2100 so that at least a portion of the body 2110 acts as a lens to display light emitted from the light source 164 to the user. The light source 164 can be controlled by the controller 900, and the controller 900 can be programmed or configured to illuminate the light source 164 in different colors, patterns, flashes, blinks, etc. to convey various messages and / or operating states to the user. For example, the controller 900 can illuminate the light source 164 in a first color to prompt the user to connect the fluid verification module 2100 to the housing 15; in a second color to indicate that air is present in the dosing line 2000; in a third color to indicate that the dosing line 2000 has been filled with saline; in a fourth color to indicate that medical fluid is flowing through the dosing line 2000; and in a fifth color to indicate that the dosing line 2000 has been used in a previous injection process and must be replaced. This is combined with Fig.14 Details regarding how the controller 900 determines the various operating states are explained.

[0102] The probe 166 can be configured to engage one or more components of the fluid verification module 2100. When the fluid verification module 2100 is not connected to the mounting flange 16, the probe 166 can form an open circuit. When the fluid verification module 2100 is connected to the mounting flange 16, one or more components of the fluid verification module 2100 can close the circuit between the probe 166. The probe 166 can then be used to measure a voltage, resistance, or other electrical characteristic of the fluid verification module 2100. For example, the probe 166 can communicate with the controller 900 and can be configured to measure or detect a change in resistance of a component of the fluid verification module 2100, indicating that the administration line 2000 has been primed. Further details of the interaction between the probe and the fluid verification module 2100 are provided herein in conjunction with the controller 900. Figure 10-13 Have a discussion.

[0103] The strain gauge 168 may be configured to be coupled to a fluid channel (e.g., the primary fluid channel 2124 (see Fig.10 The strain gauge 168 may be in communication with the controller 900 and may be used to measure the deformation of the fluid channel due to the fluid pressure, thereby providing an injection pressure value.

[0104] At least one imaging device 169 can be configured to detect and / or determine the presence of fluid in the fluid channel 2124 in the fluid verification module 2100, the type of fluid in the fluid verification module 2100, and / or the flow characteristics of the fluid in the fluid verification module 2100. The imaging device 169 can include, for example, an optical camera, an infrared camera, an ultrasonic sensor, a barcode reader, an RFID reader, etc., including combinations thereof. The imaging device 169 can communicate with the controller 900 so that the controller 900 can perform instructions based on information obtained from the imaging device 169.

[0105] Reference now Fig.10 , the body 2110 of the fluid verification module 2100 can accommodate a main fluid channel 2124 extending from an inlet port 2120 to an outlet port 2130. In some aspects or examples, the inlet port 2120 may include a one-way valve 2122 (e.g., a check valve) to prevent fluid from flowing from the main fluid channel 2124 into the first pipe section 2140. Similarly, the outlet port 2130 may include a one-way valve 2132 (e.g., a check valve) to prevent fluid from flowing from the second pipe section 2150 into the main fluid channel 2124. In some aspects or examples, the main fluid channel 2124 can be at least partially formed of a flexible material. In this way, the strain gauge 168 of the mounting flange 16 can be used to measure the fluid pressure within the main fluid channel 2124 based on the deformation of the main fluid channel 2124 due to the fluid pressure. In some aspects or examples, the main fluid channel 2124 can be at least partially transparent to allow imaging of the fluid within the main fluid channel 2124 by the imaging device 169. If the imaging device 169 is, for example, an ultrasonic device, the main fluid channel 2124 may not need to be transparent.

[0106] Continue to refer Fig.10 , the perfusion port 2154 can be in fluid communication with a perfusion chamber 2170, which can contain a fluid (e.g., saline) used to perfuse the dosing line 2000. Specifically, the controller 900 can be programmed or configured to perform a perfusion operation before the outlet connector 2152 is disconnected from the perfusion port 2154, so that the fluid used to perfuse the dosing line 2000 is contained within the perfusion chamber 2170. Therefore, the perfusion chamber 2170 prevents material from overflowing and eliminates the need to perfuse the dosing line 2000 on a waste container. In some aspects or examples, the perfusion chamber 2170 can be in fluid communication with a capillary channel 2126, which draws fluid by capillary action, for example, during a perfusion operation of the dosing line 2000. The capillary channel 2126 can have any suitable shape to facilitate capillary action, such as Fig.10 The arc, spiral or other shapes shown. Fig.14 Additional details of the priming operation are described.

[0107] Continue to refer Fig.10 And further reference Figure 11-13In some aspects or examples, the fluid verification module 2100 may include at least one fluid detection feature for determining and / or indicating whether the administration line 2000 has been used in a previous infusion procedure. In some aspects or examples, the at least one fluid detection feature may include at least one sheet of material 2180 disposed within the perfusion chamber 2170. The at least one sheet of material 2180 may be absorbent such that the perfusion fluid in the perfusion chamber 2170 is at least partially absorbed by the at least one sheet of material 2180. The at least one sheet of material 2180 may have at least one material property (e.g., electrical resistance) that changes when the at least one sheet of material 2180 absorbs the medical fluid. In some aspects or examples, the at least one sheet of material 2180 may be paper or another thin absorbent material.

[0108] In some aspects or examples, when the fluid verification module 2100 is connected to the housing 15, the at least one sheet of material 2180 can engage the probe 166 of the mounting flange 16. The body 2110 of the fluid verification module 2100 can define one or more holes 2129 through which the probe 166 can extend so as to contact the at least one sheet of material 2180. In this way, when the fluid verification module 2100 is connected to the housing 15, the at least one sheet of material 2180 closes the circuit between the probes 166. The controller 900 can be configured to measure the resistance between the probes 166 and, based on the measured resistance, determine whether the at least one sheet of material 2180 has absorbed the fluid. In this way, the controller 900 can determine whether there is fluid in the priming chamber 2170, indicating whether the administration line 2000 has been previously primed. If the controller 900 determines that the dosing line 2000 has been previously primed, and therefore used in a previous priming procedure (ie, the dosing line 2000 was not replaced according to predetermined hygienic practices), the controller 900 may prohibit a subsequent priming procedure from proceeding.

[0109] Reference now Figure 11-13 In some aspects or examples, at least one sheet of material 2180 may include a first sheet of material 2182 having a visual indicia 2183, and a second sheet of material 2184, the second sheet of material 2184 being configured to transition from an opaque state to an at least partially translucent state when the second sheet of material 2184 is contacted by a fluid. The second sheet of material 2184 may be, for example, rice paper. The second sheet of material 2184 may be disposed between the first sheet of material 2182 and a window 2112 in the body 2110 of the fluid verification module 2100. Before the dosing line 2000 is primed, the second sheet of material 2184 is in an opaque state, thereby obstructing the observation of the indicia 2183 on the first sheet of material 2182, such as Fig.12Once the perfusion fluid flows into the perfusion chamber 2170, the second sheet material 2184 absorbs the perfusion fluid and becomes at least partially transparent, so that the mark 2183 can be observed through the second sheet material 2184 and through the window 2112, as shown in FIG. Fig.13 Thus, visibility of indicia 2183 indicates to the user that dosing line 2000 has been primed and / or has been used in a previous infusion procedure.

[0110] Reference now Fig.14 , a flow chart of a method 1400 of preparing the fluid injector system 1000 to perform an injection process is shown. At step 1402, the method 1400 may include verifying that the fluid verification module 2100 is connected to the housing 15. In particular, the controller 900 may determine whether one or more engagement features 162 of the mounting flange 16 are connected to corresponding engagement features 2113 of the fluid verification module 2100. At step 1404, if the controller 900 determines that the fluid verification module 2100 is not properly connected to the housing 15, the controller 900 may illuminate the light source 164 in a first predetermined color and / or pattern to prompt the user to connect the fluid verification module 2100 to the housing 15. The controller 900 may then return to step 1402 to determine whether the fluid verification module 2100 has been properly connected to the housing 15.

[0111] At step 1406, if the fluid verification module 2100 is connected to the housing 15, the controller 900 may determine whether the dosing line 2000 has been used in a previous injection procedure. In some aspects and examples, the controller 900 may use the probe 166 to measure the resistance of the at least one sheet material 2180 to determine whether the at least one sheet material 2180 has absorbed the fluid. In some aspects and examples, the controller 900 may use the at least one imaging device 169 to detect a color change of the at least one sheet material 2180 to determine whether the at least one sheet material 2180 has absorbed the fluid. Determining that the at least one sheet material 2180 has absorbed the fluid indicates that the dosing line 2000 has been used in a previous injection procedure. In some aspects and examples, the controller 900 may use an ultrasonic air detector to detect the presence of air in the fluid verification module 2100 to determine whether the dosing line 2000 has been used in a previous injection procedure. At step 1408, if the controller 900 determines that the dosing line 2000 has been used in a previous injection process, the controller 900 may illuminate the light source 164 in a second predetermined color and / or pattern to prompt the user to discard the current dosing line 2000 and connect an unused dosing line 2000. The controller 900 may then return to step 1402 to determine whether an unused dosing line 2000 has been connected.

[0112] exist Figure 3 , 5 In aspects or examples of the fluid injector system 1000 shown in FIGS. 1 and 6 , the multi-patient intermediate tubing kit 1200 may be intended for a predetermined number of injection procedures. For example, the multi-patient intermediate tubing kit 1200 may be approved for up to five injection procedures. In these aspects or examples, the controller 900 may keep counting the number of injection procedures for which the multi-patient intermediate tubing kit 1200 has been used, and as long as the number of uses is less than the predetermined number, the controller 1400 may continue from step 1408. The controller 900 may count the number of injection procedures for which the multi-patient intermediate tubing kit 1200 has been used, for example, by counting the number of priming operations performed by the fluid injection system 1000 since the multi-patient intermediate tubing kit 1200 was connected to the housing 15. If the controller 900 determines that the multi-patient intermediate tubing kit 1200 has been used for a predetermined number of approved injection procedures, the controller 900 may prevent further injection procedures from being performed, even if the administration line 2000 has been replaced.

[0113] In step 1410, if the controller 900 determines that the dosing line 2000 has not been used in a previous injection process and the balance of the fluid injection system 1000 is ready, the controller 900 performs a priming operation. In particular, the controller 900 can actuate at least one syringe 12 to inject a priming fluid (e.g., saline) through the dosing line 2000. The controller 900 can illuminate the light source 164 in a third predetermined color and / or pattern to indicate that the priming operation is being performed. In some aspects or examples, the controller 900 can inject a predetermined volume of the priming fluid based on the known volume of the dosing line 2000. In other aspects or examples, the controller 900 can use at least one imaging device 169 to determine the type of dosing line 2000 connected to the fluid injector system 1000, and based on the determination, inject a predetermined volume of the priming fluid. For example, at least one imaging device 169 may include a barcode reader or an RFID reader to read a corresponding barcode or RFID chip on the fluid verification module 2100, which contains information such as the volume of the administration line 2000. The controller 900 may then inject a certain amount of perfusion fluid according to the information stored on the barcode or RFID chip. In other aspects or examples, the controller 900 may inject the perfusion fluid until the at least one sheet of material 2180 absorbs the perfusion fluid, as determined using the probe 166 and / or the imaging device 169. Once the perfusion operation is completed, the controller 900 may illuminate the light source 164 in a fourth predetermined color and / or pattern to indicate that the fluid injector system 1000 is ready to perform the injection process.

[0114] At step 1412, the controller 900 may initiate execution of an injection process. The injection process may include predetermined and / or preprogrammed volumes and flow rates of one or more fluids from at least one syringe 12. The controller 900 may illuminate the light source 164 in a fifth predetermined color and / or pattern to indicate that an injection process is in progress.

[0115] During the execution of the injection process, at step 1414, the controller 900 may monitor the administration line 2000 to ensure patient safety and compliance with the injection process. In particular, the controller 900 may determine whether an abnormality occurs during the injection process. In some aspects or examples, the controller 900 may monitor the presence of air in the main fluid channel 2124 through the imaging device 169. In some aspects or examples, the controller 900 may monitor the main fluid channel 2124 through the strain gauge 168 to determine the injection pressure. In step 1416, if air is detected in the main fluid channel 2124 and / or if another parameter monitored by the controller 900 is not within a predetermined limit, the controller 900 may stop the injection process. The controller 900 may illuminate the light source 164 in a sixth predetermined color and / or pattern to indicate that the injection process has stopped.

[0116] Reference now Fig.15, the electronic control device 900 can be associated with the fluid injector system 1000 to control the filling operation and the delivery operation. In some examples, the electronic control device 900 can control the operation of various valves, piston components and other elements to achieve the desired filling process or delivery process. For example, the electronic control device 900 can include a variety of discrete computer-readable media components. For example, this computer-readable medium can include any medium that can be accessed by the electronic control device 900, such as volatile media, non-volatile media, removable media, non-removable media, transient media, non-transient media, etc. As another example, this computer-readable medium can include computer storage media, such as a medium implemented in any method or technology for storing information such as computer-readable instructions, data structures, program modules or other data; random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technology; CD-ROM, digital versatile disk (DVD) or other optical disk storage; magnetic cassette, magnetic tape, disk storage or other magnetic storage device; or any other medium that can be used to store the desired information and can be accessed by the electronic control device 900. In addition, this computer-readable medium may include communication media, such as computer-readable instructions, data structures, program modules, or other data in modulated data signals (such as carrier waves or other transmission mechanisms), and include any information transmission media, wired media (such as wired networks and direct wired connections), and wireless media (such as acoustic signals, radio frequency signals, optical signals, infrared signals, biometric signals, bar code signals, etc.). Of course, combinations of any of the above should also be included in the scope of computer-readable media.

[0117] The electronic control device 900 also includes a system memory 908 having computer storage media in the form of volatile and non-volatile memory, such as ROM and RAM. A basic input / output system (BIOS) with appropriate computer-based routines assists in transferring information between the various components within the electronic control device 900 and is usually stored in ROM. The RAM portion of the system memory 908 typically contains data and program modules that can be accessed immediately or operated on in real time by the processor 904, such as operating systems, application programming interfaces, applications, program modules, program data, and other instruction-based computer readable code.

[0118] Continue to refer Fig.15, the electronic control device 900 may also include other removable or non-removable, volatile or non-volatile, transient or non-transient computer storage media products. For example, the electronic control device 900 may include: a non-removable memory interface 910, which communicates with and controls a hard disk drive 912 (e.g., a non-removable non-volatile magnetic medium); and a removable non-volatile memory interface 914, which communicates with and controls the following: a disk drive unit 916 (which reads and writes to a removable non-volatile disk 918), an optical drive unit 920 (which reads and writes to a removable non-volatile optical disk 922 such as a CDROM), a universal serial bus (USB) port 921 used in conjunction with a removable memory card, and the like. However, it is contemplated that other removable or non-removable, volatile or non-volatile computer storage media may be used in the exemplary computing system environment 902, including but not limited to magnetic tape cassettes, DVDs, digital video tapes, solid-state RAM, solid-state ROM, and the like. These various removable or non-removable, volatile or non-volatile magnetic media communicate with other components of the electronic control device 900 and the processor 904 via the system bus 906. Fig.15 The drives and their associated computer storage media shown in the figure provide storage of operating systems, computer readable instructions, applications, data structures, program modules, program data, and other instruction-based computer readable code for the electronic control device 900 (regardless of whether the information and data are copied in the system memory 908).

[0119] The user can input commands, information and data into the electronic control device 900 via the user input interface 928 through some attachable or operable input device (such as a user interface on the housing 15). A variety of such input devices can be used, such as microphones, trackballs, joysticks, touch pads, touch screens, scanners, etc., including any arrangement that facilitates the input of data and information from external sources to the electronic control device 900. As discussed, these and other input devices are often connected to the processor 904 through the user input interface 928 coupled to the system bus 906, but can be connected by other interfaces and bus structures (such as parallel ports, game ports or USB). Further, data and information can be presented or provided to the user in an understandable form or format through some output devices, such as a monitor 930 (for visually displaying this information and data in electronic form), a printer 932 (for physically displaying this information and data in printed form), a speaker 934 (for audibly presenting this information and data in audible form), etc. All of these devices communicate with the electronic control device 900 through an output interface 936 coupled to the system bus 906. It is contemplated that any such peripheral output devices may be used to provide information and data to a user.

[0120] The electronic control device 900 can operate in a network environment 938 by using a communication device 940 that is integrated with or remote from the electronic control device 900. The communication device 940 is operable by and in communication with other components of the electronic control device 900 through a communication interface 942. Using this arrangement, the electronic control device 900 can connect or otherwise communicate with one or more remote computers, such as remote computers 944, which can be personal computers, servers, routers, network personal computers, peer devices, or other public network nodes, and typically include many or all of the components described above in conjunction with the electronic control device 900. Using appropriate communication devices 940 (e.g., modems, network interfaces or adapters, etc.), the computer 944 can operate within and communicate through local area networks (LANs) and wide area networks (WANs), but may also include other networks, such as virtual private networks (VPNs), office networks, enterprise networks, intranets, the Internet, etc.

[0121] As used herein, the electronic control device 900 includes or is operable to execute appropriate specially designed software or conventional software to perform and implement the processing steps of the methods and systems of the present disclosure, thereby forming a dedicated and specific computing system. Therefore, the methods and systems may include one or more electronic control devices 900 or similar computing devices having a computer-readable storage medium that can store computer-readable program code or instructions that cause the processor 904 to perform, configure, or otherwise implement the methods, processes, and conversion data manipulations discussed herein in conjunction with the present disclosure. Further, the electronic control device 900 can be in the form of a personal computer, a personal digital assistant, a portable computer, a laptop computer, a handheld computer, a mobile device, a mobile phone, a server, or any other type of computing device having the processing hardware necessary to appropriately process data to effectively implement the fluid injector system 1000, the computer program product, and the computer-implemented methods of the present disclosure.

[0122] Those skilled in the relevant art will appreciate that the system can utilize a database physically located on one or more computers (which may or may not be the same as their corresponding servers). For example, the programming software on the electronic control device 900 can control a database physically stored on a separate processor of the network or stored in other ways.

[0123] Although examples of fluid injector systems, dosing lines, and methods of operating the same are provided in the foregoing description, those skilled in the art may modify and alter these examples without departing from the scope and spirit of the present disclosure. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The above disclosure herein is defined by the appended claims, and all changes to the disclosure that fall within the meaning and equivalent scope of the claims are included within the scope of the claims.

Claims

1. A drug delivery line (2000) for use with a fluid injector system (1000), the fluid injector system comprising a controller (900) and at least one fluid reservoir (12), the controller (900) being programmed to perform operations of the fluid injector system (1000), including priming operations and injection processes, the drug delivery line (2000) comprising: A fluid verification module (2100) configured to be in operative communication with the housing (15) of the fluid injector system (1000), whereby the fluid injector system (1000) is able to determine the status of the administration line (2000), including whether the administration line (2000) has been used in a previous injection process, is not properly primed with a perfusion fluid, and is not properly connected to the housing (15), the fluid verification module (2100) comprising: a body (2110) defining a perfusion port (2154), an inlet port (2120), an outlet port (2130), a fluid passage (2124) extending from the inlet port (2120) to the outlet port (2130), and a perfusion chamber (2170) in fluid communication with the perfusion port (2154); a first tubing portion (2140) having one end connected to the inlet port (2120) of the body (2110) and having an inlet connector (2142) at the other end thereof, such that the inlet connector (2142) is configured to (i) connect to one of the dust cap of the fluid verification module (2100) and the body (2110) during storage or transportation of the administration line (2000), and (ii) be in fluid communication with the at least one fluid reservoir (12) during the priming operation and the injection process; and a second tubing portion (2150) connected to the outlet port (2130) of the body (2110) and having an outlet connector (2152) at the other end thereof, such that the outlet connector (2152) is configured to (i) connect to one of the irrigation port (2154) and the dust cap during storage or transportation of the administration line (2000), (ii) connect to the irrigation port (2154) during the irrigation operation, and (iii) connect to one of a catheter and a needle adapted for insertion into a vascular location of a patient during the injection procedure; wherein the priming chamber (2170) of the fluid verification module (2100) is configured to retain the priming fluid received from the outlet connector (2152) of the second tubing portion (2150) via the priming port (2154) during a priming operation of the administration line (2000); and the administration line (2000) further comprises: at least one sheet of material (2180) disposed within the perfusion chamber (2170), the at least one sheet of material (2180) being configured to change resistance when in contact with the perfusion fluid in the perfusion chamber (2170), and When the fluid verification module (2100) is installed to the housing (15) of the fluid injector system (1000), the at least one sheet material (2180) is configured to be connected to at least one probe (166) of the fluid injector system (1000) for measuring the resistance of the at least one sheet material (2180).

2. The administration line (2000) of claim 1, wherein the inlet connector (2142) is configured to be connected to an intermediate tubing set (1200) in fluid communication with the at least one fluid reservoir (12) of the fluid injector system (1000) during the priming operation and the injection process, in, The intermediate tubing kit (1200) comprises a first inlet connector (1210) for connecting to a first fluid reservoir (12) of the at least one fluid reservoir (12) and a second inlet connector (1220) for connecting to a second fluid reservoir (12) of the at least one fluid reservoir (12), and The inlet connector (2142) is configured to connect to a blind port (2156) of the body (2110) of the fluid verification module (2100) during storage or transportation of the dosing line (2000).

3. The drug delivery line (2000) according to claim 2, wherein the at least one fluid reservoir (12) comprises a first fluid reservoir (12) and a second fluid reservoir (12), and the first tubing portion (2140) further comprises: a first inlet connector (2142) configured for connection to a first fluid reservoir (12) of the fluid injector system (1000); and a second inlet connector (2144), the second inlet connector (2144) being configured for connection to a second fluid reservoir (12) of the fluid injector system (1000), Wherein the first inlet connector (2142) is configured to be connected to the second inlet connector (2144) during storage or transportation of the administration line (2000).

4. The drug delivery line (2000) according to claim 1, wherein the body (2110) of the fluid verification module (2100) further comprises a capillary channel (2126), wherein the capillary channel (2126) is fluidically connected to the perfusion chamber (2170) and is configured to draw at least a portion of the perfusion fluid by capillary action.

5. The drug delivery line (2000) of claim 1, wherein at least a portion of the body (2110) of the fluid verification module (2100) is configured to act as a lens to display light emitted from a light source of the fluid injector system (1000).

6. The administration line (2000) according to claim 1, wherein the body (2110) of the fluid verification module (2100) comprises one or more engagement features (162), and the one or more engagement features (162) are configured to fasten the fluid verification module (2100) to the housing (15) of the fluid injector system (1000).

7. The drug delivery line (2000) of claim 1, wherein the fluid channel (2124) is at least partially transparent such that an imaging device of the housing (15) can determine whether fluid is present in the fluid channel (2124).

8. The drug administration line (2000) according to claim 1, wherein the fluid channel (2124) is flexible and is configured to be connected to a strain gauge (168) of the housing (15) so that the strain gauge (168) can determine the fluid pressure in the drug administration line (2000).

9. The drug delivery line (2000) according to claim 1, further comprising at least one of the following: an inlet check valve (2141) in the first conduit portion (2140) associated with the inlet port (2120); and an outlet non-return valve (2151) in the second pipe section (2150) associated with the outlet port (2130), At least one of the inlet check valve (2141) and the outlet check valve (2151) prohibits fluid from flowing in an upstream direction from the second pipeline portion (2150) to the first pipeline portion (2140).

10. A fluid injector system (1000) configured to perform an injection procedure in conjunction with a diagnostic imaging procedure, the fluid injector system (1000) comprising: Drug delivery pipeline (2000), including: A fluid verification module (2100) comprising a body (2110) defining a perfusion port (2154), an inlet port (2120), an outlet port (2130), a fluid channel (2124) extending from the inlet port (2120) to the outlet port (2130), and a perfusion chamber (2170) in fluid communication with the perfusion port (2154); a first tubing portion (2140) having one end connected to the inlet port (2120) of the body (2110) and having an inlet connector (2142) at the other end thereof, such that the inlet connector (2142) is configured to (i) connect to one of the dust cover of the fluid verification module (2100) and the body (2110) during storage or transportation of the administration line (2000), and (ii) be in fluid communication with at least one fluid reservoir (12) during a priming operation of the fluid injection system (1000) and the injection process; and a second tubing portion (2150) connected to the outlet port (2130) of the body (2110) and having an outlet connector (2152) at the other end thereof, such that the outlet connector (2152) is configured to (i) connect to one of the irrigation port (2154) and the dust cap during storage or transportation of the administration line (2000), (ii) connect to the irrigation port (2154) during the irrigation operation, and (iii) connect to one of a catheter and a needle adapted for insertion into a vascular location of a patient during the injection procedure, wherein the priming chamber (2170) of the fluid verification module (2100) is configured to retain priming fluid received from the outlet connector (2152) of the second tubing portion (2150) via the priming port (2154) during a priming operation of the administration line (2000); and the administration line (2000) further comprises: at least one sheet of material (2180) disposed within the perfusion chamber (2170), the at least one sheet of material (2180) being configured to change resistance when in contact with the perfusion fluid in the perfusion chamber (2170), and wherein when the fluid verification module (2100) is mounted to the housing (15) of the fluid injector system (1000), the at least one sheet of material (2180) is configured to interface with at least one probe (166) of the fluid injector system (1000) for measuring the resistance of the at least one sheet of material (2180); and A controller (900) operably connected to the fluid verification module (2100) is programmed or configured to use the at least one probe (166) to determine the resistance of the at least one sheet of material (2180), thereby determining the status of the administration line (2000), including whether the administration line (2000) has been used in a previous injection process, is not properly primed with the perfusion fluid, and is not properly connected to the housing (15).

11. The fluid injector system (1000) of claim 10, wherein the controller (900) is programmed or configured to inhibit execution of an injection process in response to determining via the at least one probe (166) that the at least one sheet of material (2180) has previously been contacted by the perfusion fluid.

12. The fluid injector system (1000) of claim 10, further comprising a light source (164) in communication with the controller (900), Wherein at least a portion of the body (2110) of the fluid verification module (2100) is configured to act as a lens to display light emitted from the light source (164) by the controller (900).

13. The fluid injector system (1000) of claim 10, further comprising an imaging device (169) in communication with the controller (900), The fluid channel (2124) is at least partially transparent, so that the controller (900) can determine whether fluid is present in the fluid channel (2124) through the imaging device (169).

14. The fluid injector system (1000) of claim 13, wherein the controller (900) is programmed or configured to stop execution of a fluid injection procedure in response to detecting air in the fluid channel (2124) via the imaging device (169).

15. The fluid injector system (1000) of claim 10, further comprising a strain gauge (168) in communication with the controller (900), The fluid channel (2124) is flexible and is configured to be connected to the strain gauge (168) so that the controller (900) can determine the fluid pressure in the drug delivery line (2000) through the strain gauge (168).

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