SYSTEM FOR CONDUCTING A FLUID INJECTION PROCEDURE
20210193289 · 2021-06-24
Inventors
Cpc classification
A61M2205/6009
HUMAN NECESSITIES
A61J2205/60
HUMAN NECESSITIES
A61M2005/14208
HUMAN NECESSITIES
A61J1/2089
HUMAN NECESSITIES
G16H10/60
PHYSICS
A61M5/14566
HUMAN NECESSITIES
A61M5/16827
HUMAN NECESSITIES
A61M2205/52
HUMAN NECESSITIES
International classification
A61J1/20
HUMAN NECESSITIES
G16H10/60
PHYSICS
Abstract
A system for conducting a fluid injection procedure comprises: a loading device for filling containers with fluid; an information read/write device operatively associated with the loading device and configured to: read information related to the containers stored on information storage devices associated with the containers and write information related to an injection procedure and/or a patient to the information storage devices; and a fluid injector system configured to receive the containers after filling by the loading device and inject the contents of the containers of fluid into the patient. The loading device is configured to fill the containers with fluid based on the information related to the containers read from the information storage devices. The information read/write device is configured to write information to the information storage device. The fluid injector system is configured to read the information and use this information to program the fluid injector system.
Claims
1. A system for conducting a fluid injection procedure, the system comprising: (a) a container loading system comprising a loading device for filling one or more containers with fluid; (b) an information read/write device operatively associated with the loading device and configured to: read information related to the one or more containers stored on one or more information storage devices associated with the one or more containers; and write information related to at least one of an injection procedure and a patient to the one or more information storage devices; and (c) a fluid injector system configured to receive the one or more containers after filling by the container loading system and inject contents of the one or more containers of fluid into the patient, wherein (i) the loading device is configured to fill the one or more containers with fluid based on the information related to the one or more containers read from the one or more information storage devices by the information read/write device; (ii) the information read/write device is configured to write the information related to at least one of the injection procedure and the patient to the information storage device as the loading device is filling the one or more containers with fluid; and (iii) the fluid injector system is configured to read the information related to at least one of the injection procedure and the patient from the one or more information storage devices when the one or more containers are received by the fluid injector system and the information related to at least one of the injection procedure and the patient is used to program the fluid injector system to conduct the injector procedure.
2. The system of claim 1, wherein the one or more containers of fluid includes a container of contrast media and a container of saline.
3. The system of claim 2, wherein the container of contrast media and the container of saline are coupled together via a collar.
4. The system of claim 3, wherein the one or more information storage devices are provided on the collar.
5. The system of claim 4, wherein removal of the collar from the container of contrast media and the container of saline removes information stored on the one or more information storage devices, thereby allowing the collar to be reused.
6. The system of claim 2, wherein the container of contrast media and the container of saline are coupled together via a faceplate.
7. The system of claim 6, wherein the faceplate is configured to removably engage both the container loading system and the fluid injector system.
8. The system of claim 6, wherein the one or more information storage devices are provided in the faceplate.
9. The system of claim 6, wherein the faceplate comprises a display device for displaying at least one of: information regarding the patient and information regarding a fluid injection procedure.
10. The system of claim 1, wherein the information read/write device is an RFID read/write device and the one or more information storage devices are RFID tags.
11. The system of claim 1, wherein the information related to the one or more containers stored on the one or more information storage devices comprises at least one of the following items: (i) a type of the contrast media; (ii) a concentration of the contrast media; (iii) a manufacturer of the contrast media; (iv) a lot number of the contrast media; (v) a serial number of the contrast media; (vi) a manufacturer instructions for the contrast media; (vii) a creation date of the contrast media; (viii) an expiration date of the contrast media; and (ix) a size of the one or more containers.
12. The system of claim 11 wherein the information related to the one or more containers stored on the one or more information storage devices is generated by the manufacturer or supplier of the fluid contained in the one or more containers.
13. The system of claim 1, wherein the information related to at least one of the injection procedure and the patient written to the one or more information storage devices comprises at least one of (i) a pressure and a flow rate to be used by the fluid injector system; (ii) patient weight information; (iii) patient height information; (iv) patient age information; (v) patient name information; (vi) hospital information; (vii) department information; (viii) doctor information; (ix) medical procedure information; (x) medical imaging information; and (xi) automated injection information.
14. The system of claim 1, wherein the information read/write device is a barcode reader and a barcode printer and the one or more information storage devices are barcode labels.
15. The system of claim 14, wherein the barcode reader reads information related to the one or more containers stored on one or more bar code labels associated with the one or more containers; and the barcode printer prints bar code labels including information related to at least one of the injection procedure and the patient.
16. A system for conducting a fluid injection procedure, the system comprising: (a) a container loading system comprising a loading device for filling one or more containers with fluid; (b) a data entry system associated with the loading device and configured to allow entry of at least one of information related to the one or more containers; information related to at least one of an injection procedure; and information related to a patient; (c) a controller operatively connected to the loading device and the data entry system and configured to receive at least one of the information related to the one or more containers, the information related to at least one of the injection procedure and the information related to the patient and associate at least one of the information related to the one or more containers, the information related to at least one of the injection procedure and the information related to the patient with the one or more containers as the loading device is filling the one or more containers with fluid; (d) a communication device operatively connected to the controller and configured to transmit at least one of the information related to the one or more containers, the information related to at least one of the injection procedure and the information related to the patient; and (e) a fluid injector system configured to: receive at least one of the information related to the one or more containers, the information related to at least one of the injection procedure and the information related to the patient from the communication device and associate at least one of the information related to the one or more containers, the information related to at least one of the injection procedure and the information related to the patient with the one or more containers when the one or more containers are mounted to the fluid injector system.
17. The system of claim 16, wherein at least one of the information related to the one or more containers, the information related to at least one of the injection procedure and the information related to the patient is associated with the one or more containers as the loading device is filling the one or more containers with fluid by at least one of: assigning the one or more containers with a unique code that can be entered into the fluid injector system; and storing at least one of the information related to the one or more containers, the information related to at least one of the injection procedure and the information related to the patient on a data storage device provided on the one or more container.
18. The system of claim 17, wherein the data storage device is one of an RFID tag and a barcode label.
19. The system of claim 16, wherein the information related to the one or more containers comprises at least one of the following items: (i) a type of the contrast media; (ii) a concentration of the contrast media; (iii) a manufacturer of the contrast media; (iv) a lot number of the contrast media; (v) a serial number of the contrast media; (vi) a manufacturer instructions for the contrast media; (vii) a creation date of the contrast media; (viii) an expiration date of the contrast media; and (ix) a size of the one or more containers.
20. The system of claim 19, wherein the information related to the one or more containers is generated by the manufacturer or supplier of the fluid contained in the one or more containers.
21. The system of claim 16, wherein the information related to the injection procedure and the information related to the patient comprises at least one of: (i) a pressure and a flow rate for the fluid injector system; (ii) patient weight information; (iii) patient height information; (iv) patient age information; (v) patient name information; (vi) hospital information; (vii) department information; (viii) doctor information; (ix) medical procedure information; (x) medical imaging information; and (xi) automated injection information.
22. The system of claim 16, wherein the one or more containers of fluid includes a container of contrast media and a container of saline.
23. The system of claim 16, wherein the communication device comprises a communication port configured to provide one or more communication methods selected from the group consisting of: Ethernet, wireless protocols, serial, universal serial bus (USB), parallel port, and Bluetooth.
24. The system of claim 16, wherein the communication device is configured to transmit at least one of the information related to the one or more containers, the information related to at least one of the injection procedure and the information related to the patient to one or more of: a personal computing device; a server; a distributed computing system; a mobile computing device; a picture archiving and communication system (PACS); a healthcare information and management systems (HIMS); an electronic medical record (EMR) system; a radiology information system (RIS); and a contrast information management system.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0061] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof, shall relate to the device of the present disclosure as it is oriented in the drawing figures. However, it is to be understood that the device of the present disclosure may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the device of the present disclosure. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
[0062] As used herein, the terms “communication” and “communicate” refer to the receipt or transfer of one or more signals, messages, commands, or other type of data. For one unit or device to be in communication with one or more other unit or device means that the one unit or device is able to receive data from and/or transmit data to the one or more other unit or device. A communication may use a direct or indirect connection, and may be wired and/or wireless in nature. Additionally, two or more units or devices may be in communication with each other even though the data transmitted may be modified, processed, routed, etc., between the first and second unit or device. For example, a first unit may be in communication with a second unit even though the first unit passively receives data and does not actively transmit data to the second unit. As another example, a first unit may be in communication with a second unit if an intermediary unit processes data from one unit and transmits processed data to the second unit. In non-limiting examples, a communication may occur through one or more wired or wireless connections, such as, through one or more wires, through direct wireless protocols such as Bluetooth, Near Field Communication (NFC), or other radio frequency protocols, and/or through indirect wireless communication such as through a local Wi-Fi network or secure Internet connection. Wireless communication may include, but is not limited to, any communication that does not require direct wired contact between the two communicating units or devices such as via a Wi-Fi network, communication via Bluetooth, NFC, or other conventional wireless system, or other non-wired electromagnetic communication systems. It will be appreciated that numerous other arrangements are possible.
[0063] The present disclosure relates a fluid injection system including a loading system and a fluid injector. The loading system is for use in loading contrast media and diluent, such as saline, into separate syringes prior to installation of those syringes in the fluid injector via which the injection procedure is to be performed as part of a contrast enhanced imaging procedure. The loading system is capable of writing to one or more information storage devices associated with the syringes on which information pertaining to the syringes, the contrast media and/or diluent therein, the injection procedure, and the patient is to be stored. The fluid injector may be configured as a dual syringe fluid injection system that, upon receiving the syringes, is capable of reading from the one or more information storage devices associated with those syringes the information pertaining to the syringes, the contrast media and/or diluent therein, the injection procedure, and the patient and using such information to program the dual syringe fluid injection system to permit the injection procedure to be performed on the patient.
[0064] More specifically,
[0065] In some embodiments, the user interface 13 and the information read/write device 15 may be integrally formed with the housing 11 of the container loading device 3. Alternatively, as discussed with reference to
[0066] With reference to
[0067] A controller 29 interfaces with one or more optional memory devices 31 to the system bus 23. These memory devices 31 may include, for example, an external or internal DVD drive, a CD ROM drive, a hard drive, flash memory, a USB drive or the like. These various drives and controllers are optional devices.
[0068] Program instructions, software or interactive modules for providing the interface and performing any querying or analysis associated with one or more data sets may be stored in the ROM 25 and/or the RAM 27. Optionally, the program instructions may be stored on a tangible computer readable medium such as a compact disk, a digital disk, flash memory, a memory card, a USB drive, an optical disc storage medium, such as a Blu-ray™ disc, and/or other non-transitory storage media.
[0069] An optional display interface 33 may permit information from the bus 23 to be displayed on the display 35, which may be part of the user interface 13, in audio, visual, graphic, or alphanumeric format. Communication with external devices, such as a print device, which may be part of the information read/write device 15, may occur using various communication ports 37. An exemplary communication port 37 may be attached to a communications network, such as the Internet or an intranet.
[0070] The hardware may also include an interface 39 which allows for receipt of data from input devices such as a keyboard 41 or other input device 43 such as a mouse, a joystick, a touch screen, a remote control, a pointing device, a video input device and/or an audio input device. The keyboard 41 and other input devices 43 may also be part of the user interface 13.
[0071] Returning to
[0072] More specifically, the container loading device 3 is configured to fill the syringes 5 with fluid based on the information related to the syringes 5 read from the one or more information storage devices by the information read/write device 5. Thereafter, the information read/write device 15 is configured to write information related to at least one of the injection procedure and the patient to the information storage device as the container loading device 3 is filling syringes 5 with fluid. As will be discussed in greater detail hereinafter, a fluid injector system is then configured to read the information related to the injection procedure and/or the patient from the information storage device when the syringes 5 are received by the fluid injector system and the information related to the injection procedure and/or the patient is then used to program the fluid injector system to conduct the injector procedure.
[0073] The information storage device may be any suitable device that may have information written thereto and read therefrom. For example, the information read/write device 15 may be configured as a radiofrequency identification (RFID) read/write device and the one or more information storage devices are RFID tags. The information related to the syringes 5 stored on the one or more information storage devices may include one or more of the following items: (i) a type of the contrast media, (ii) a concentration of the contrast media, (iii) a manufacturer of the contrast media, (iv) a lot number of the contrast media, (v) a serial number of the contrast media, (vi) a manufacturer instructions for the contrast media, (vii) a creation date of the contrast media, (viii) an expiration date of the contrast media, and (ix) a size of the one or more containers. Such information may be generated by the manufacturer or supplier of the fluid contained in the one or more containers. In addition, the information related to the injection procedure and/or the patient written to the one or more information storage devices may include one or more of the following: (i) a pressure and a flow rate for the fluid injector system, (ii) patient weight information, (iii) patient height information, (iv) patient age information, (v) patient name information, (vi) hospital information, (vii) department information, (viii) doctor information, (ix) medical procedure information, (x) medical imaging information, and (xi) automated injection information.
[0074] Alternatively, the information read/write device 15 may be configured as a barcode reader and a barcode printer and the one or more information storage devices are barcode labels. In such an example, the barcode reader reads information related to syringes 5 stored on one or more bar code labels associated with the syringes 5 and the barcode printer prints bar code labels including information related to at least one of the injection procedure and the patient.
[0075] In a variety of instances, it may be desirable to connect the syringe 5 for contrast and the syringe 5 for saline. For example, the syringes 5 may be used in a dual-syringe fluid injector designed for the administration of two fluids such as contrast and saline. In such injection systems, the two containers of fluid disclosed herein may take the form of two syringes 5 and those syringes may be coupled together, as shown in
[0076] It is desirable to couple the syringes 5 when using a dual-syringe fluid injector such that the syringes 5 are indexed to the injector so that they are held in the proper orientation and distance for insertion into the injector; allow for a user to quickly and easily install the syringes 5 into and remove them from the injector, and improve workflow by requiring fewer steps for setup of the injection procedure. With reference to
[0077] With reference to
[0078] Returning to
[0079] During this loading operation, after being programmed with the requisite information, the information storage device 47 will ideally be designed so as to retain the information for at least as long as it is connected to the collar. In addition, information storage device 47 may be designed so that it automatically erases upon being removed from the collar 45 or upon removal of the collar 45 from the syringes 5. In such instances, the collar 45 and/or the information storage device 47 can be reused. When the syringes 5 are removed from the container loading device, the appropriate connector tubing or fluid path set 83 can then be attached to the syringes 5 before leaving the control room (as shown in
[0080] Once the syringes 5 have been filled as described hereinabove, they are transported to the injection system to begin an injection procedure. Various examples of the present disclosure are directed to fluid injection systems for injecting one or more fluids into a patient during an injection procedure. In particular examples, the fluid injection systems of the present disclosure may be used for injection of one or more imaging agents in an imaging procedure, such as, for example, CT scan, MRI, and other radiological imaging procedures. The various examples of the fluid injection systems may comprise an injector assembly comprising at least one syringe port for interfacing with a syringe and be configured to inject one or more medical fluids during an imaging procedure.
[0081] In specific examples, the fluid injector system may be a front-loading fluid injector system similar to the various examples of the injectors disclosed in U.S. Pat. Nos. 5,383,858, 7,553,294, 7,666,169, 9,173,995, 9,199,033 and in International Patent Application Publication No. WO2016/191485, and in U.S. Patent Application Publication No. 2014/0027009, the disclosures of which are incorporated by reference in their entirety.
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[0083] The injector 101 may have a housing 103 formed from a suitable structural material, such as plastic, a composite material, and/or metal. The housing 103 may be of various shapes and sizes depending on the desired application. For example, the injector 101 may be a freestanding structure having a support portion connected to a base with one or more rollers or wheels such that the injector 101 is movable over the floor. In other examples, the injector 101 may have smaller design for placement on a suitable table or support frame. The injector 101 may include a pair of syringe ports 105 for releasably connecting the syringes 5 to respective piston elements. In various examples, the syringes 5 each include at least one syringe retaining member (not shown) configured for retaining the syringes 5 within the respective syringe port 105 of the injector 101. In non-limiting examples, the at least one syringe retaining member is configured to operatively engage a locking mechanism provided on or in the syringe port 105 of the injector 101 to facilitate self-oriented loading and/or removal of the syringes 5 to and from the injector 101. The syringe retaining member and the locking mechanism together define a connection interface for connecting the syringes 5 to the injector 101.
[0084] In non-limiting examples, at least one fluid path set 83 may be fluidly connected with the distal end of the syringes 5 for delivering medical fluid from the syringes 5 to a catheter, needle, or other fluid delivery connection (not shown) inserted into a patient at a vascular access site. Fluid flow from the syringes 5 may be regulated by a fluid control module operated by a controller. The fluid control module may operate various, pistons, valves, and/or flow regulating devices to regulate the delivery of the medical fluid, such as saline solution and contrast, to the patient based on one or more user selected injection parameters, such as injection flow rate, duration, total injection volume, and/or ratio of contrast media and saline. In one example, the injection parameters may be automatically provided to the fluid control module when the syringes 5 are installed on the injector 101. More specifically, upon installation of the syringes 5 and associated collar 45 onto the injector 101 as best shown in
[0085] With reference to
[0086] Once the syringes are filled and the relevant information is transferred to the faceplate 201 as described above, the faceplate 201 and filled syringes 5 are moved from the loading device 211 to the injector 203 as shown in
[0087] With reference to
[0088] The container loading device 303 includes: a housing 307 configured to receive at least one empty syringe 309 and bulk fluid sources 311, 313; a user interface 315 configured to allow a user to control the container loading system 303 to fill the syringes 309 and to allow entry of at least one of information related to the syringes 309, information related to at least one of an injection procedure, and information related to a patient; and an information read/write device 317 configured to: read information related to the syringes 309 stored on one or more information storage devices associated with the syringes 309; and write information related to at least one of an injection procedure and a patient to the one or more information storage devices.
[0089] The information read/write device 317 may be configured to read information associated with the syringes 309 and write information that is to be associated with the syringes 309. For example, each syringe 309 may be associated with one or more labels. Non-restrictive examples of labels include text-based, RFID, barcodes (one dimensional (1D) and/or two-dimensional (2D)), and QR codes. The information read/write device 317 may be configured to read the information associated with a corresponding type of label and thereafter write information to the label. For instance, information read/write device 317 may include an RFID read/write device configured to read RFID labels and then write information to the labels. In another instance, the information read/write device 317 may include an OCR reader configured to scan text-based labels and provide text information to one or more information consumers (e.g., the user interface 315). The information read/write device 317 may further include one or more printers 319 configured to generate labels including barcodes or QR codes to affix to the syringes 309. Some embodiments provide that information read by the information read/write device 317 may be transmitted within the system 301. For example, the information from a syringe 309 for use by a patient having a diagnostic imaging exam may be sent to the user interface 315, a PACS system, and to the fluid injector 305 that will be used to inject the contrast into the patient. In general, information obtained by the information read/write device 317 may be generally available for transmission within the system 301 to electronic devices and computing devices configured to receive and handle the information.
[0090] In some embodiments, the user interface 315, the information read/write device 317, and the printer 319 may be integrally formed with the housing 307 of the container loading system 303. Alternatively, as shown in
[0091] The loading system 303 further includes a controller that is operatively connected thereto and to the data entry system. The controller may be any suitable processing device as discussed hereinabove with reference to
[0092] The information related to the syringes 309 may be any one or combination of the following items: (i) a type of the contrast media, (ii) a concentration of the contrast media, (iii) a manufacturer of the contrast media, (iv) a lot number of the contrast media, (v) a serial number of the contrast media, (vi) a manufacturer instructions for the contrast media, (vii) a creation date of the contrast media, (viii) an expiration date of the contrast media, and (ix) a size of the one or more containers. In addition, the information related to the syringes 309 may be generated by the manufacturer or supplier of the fluid contained in the syringes 309.
[0093] The information related to the injection procedure and information related to the patient may be any one or combination of the following items: (i) a pressure and a flow rate for the fluid injector system, (ii) patient weight information, (iii) patient height information, (iv) patient age information, (v) patient name information, (vi) hospital information, (vii) department information, (viii) doctor information, (ix) medical procedure information, (x) medical imaging information, and (xi) automated injection information.
[0094] The loading system 303 may further include a communication device 321 that is operatively connected to the controller and is configured to transmit at least one of (i) the information related to the syringes 309, (ii) the information related to the injection procedure, and (iii) the information related to the patient. The communication device 321 may be provided within the housing 307 of the loading system 303 as shown in
[0095] As shown in
[0096] The fluid injector system 305 is configured to: receive at least one of (i) the information related to the syringes, (ii) the information related to at least one of the injection procedure, and (iii) the information related to the patient from the communication device; and to associate at least one of (i) the information related to the one or more containers, (ii) the information related to at least one of the injection procedure, and (iii) the information related to the patient with the one or more containers when the one or more containers are mounted to the fluid injector system. Based on this information, the fluid injector system 305 is armed and a fluid injection procedure may then be conducted.
[0097] According to some embodiments, the servers 327 may be part of one or more information systems including, but not limited to, a picture archiving and communication system (PACS), healthcare information and management systems (HIMS), electronic medical record (EMR) systems, radiology information systems (RIS), laboratory information systems (LIS), contrast information management systems, and medical imaging and procedure equipment information systems (e.g., contrast injector systems). Some embodiments provide that the loading device, the network, and/or other information systems may be in communication with various other information platforms, such as the Certegra® Workstation offered by Bayer Healthcare. Such features allow, for example, protocol management and the generation of injection protocols using any of the Certegra® P3T software modules. For example, when used with injection systems such as the MEDRAD® Stellant CT Injection System offered by Bayer, the P3T® Cardiac, P3T® Abdomen and P3T® Pulmonary Angiography modules allow Radiologists to personalize the injection protocols for CT cardiac, pulmonary, and abdomen (liver, pancreas, and kidneys) studies, respectively. In addition to its contrast dose management capabilities, the Certegra® Workstation also enables interaction with the Modality Worklist functionality of various OEM scanners and, via its Manage.Report and Connect.PACS capabilities, transfer of injection protocol and other data to hospital IT systems including the PACS, HIMS, RIS, LIS, EMR, and the speech reporting systems used by Radiologists.
[0098] The personal computing devices 325 and mobile computing devices 329 may be used to access information and to perform functions within the loading system 303. For example, a personal computing device 325 may be configured to access a user interface (e.g., similar to the user interface 315) to access information and to perform functions associated with the loading device 303. In this manner, users may remotely access the loading system 303 and/or the user interface 315 associated therewith.
[0099] While specific embodiments of the present invention have been described in detail, it will be appreciated by those skilled in the art that various modifications and alternatives to those details could be developed in light of the overall teachings of the disclosure. Accordingly, the particular arrangements disclosed are meant to be illustrative only and not limiting as to the scope of the device of the present disclosure which is to be given the full breadth of the claims appended and any and all equivalents thereof.