Detectable disinfection cap and method for tracking same - Patent Application 20070122997
The integration of fiducial markers in antiseptic caps for vascular access devices automates catheter maintenance tracking, reducing errors and CRBSI risks by ensuring proper disinfection cap usage and replacement.
Patent Information
- Application Number
- JP2025536307
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-12-19
- Filing Date
- 2023-12-18
- Publication Date
- 2025-12-25
AI Technical Summary
Existing catheter maintenance processes for vascular access devices (VADs) are time-consuming, duplicative, and error-prone, leading to inefficiencies and an increased risk of catheter-related bloodstream infections (CRBSIs).
An antiseptic cap with fiducial markers, such as AprilTags, is integrated into the catheter connector system, enabling tracking and monitoring of disinfection cap usage through image capture devices, which determine the presence, position, and status of the cap, thereby automating the tracking of catheter line access and disinfection cap replacement.
The system reduces errors and inefficiencies in catheter maintenance, enhancing the standard of care by providing real-time monitoring and alerting for proper disinfection cap usage, thus minimizing the risk of CRBSIs.
Smart Images

Figure 2025542276000001_ABST
Abstract
Description
[Technical Field]
[0001] The present disclosure relates generally to caps for medical connectors, and more particularly to detectable antiseptic caps that include fiducial markers to enable their tracking and identification as part of a vascular access management system. [Background technology]
[0002] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Utility Application No. 1,8 / 068,049, filed December 19, 2022, and entitled "Detectable Disinfection Cap and Method for Tracking Thereof," the entire disclosure of which is incorporated herein by reference in its entirety.
[0003] [Description of Related Art] Catheters are commonly used to administer fluids into and out of the body. In various settings, including hospitals and home care, patients receive fluids, medications, and blood products via vascular access devices (VADs), which include catheters inserted into the patient's vascular system. A typical VAD includes a plastic catheter inserted into a patient's vein, and the length of the catheter varies from a few centimeters if the VAD is a peripheral intravenous catheter (PIVC) to many centimeters if the VAD is a central venous catheter (CVC). VADs may be left in place for short-term (days), medium-term (weeks), or long-term (months to years).
[0004] Without proper maintenance or exposure to non-sterile environments, VADs can become contaminated, become embolized with blood clots, and / or transmit infection. Furthermore, when connected to a VAD to deliver fluids or medications to a patient, bacteria and other microorganisms can enter the patient's vascular system through the access hub, port, or valve. Therefore, each access hub / port / valve on a VAD configured to connect to a VAD is associated with a risk of transmitting a catheter-related bloodstream infection (CRBSI) to the patient.
[0005] To reduce the incidence of CRBSI and ensure proper use and maintenance of VADs, many healthcare facilities have implemented sterilization procedures and protocols to ensure VADs and access connectors are properly used, sealed, and not infected. These protocols often include sterilization of the access hub, port, and VAD, and mandate that the access hub, port, and valve be covered with a disinfectant cap when not in use to prevent microbial entry into the hub, port, or valve and to sterilize the VAD hub, port, and valve area. Disinfection caps are disposable caps that contain an appropriate amount of cleaning or disinfectant solution to sterilize the port, hub, and valve area.
[0006] Even when using antiseptic caps as part of catheter care maintenance, clinicians are recognized as continuing to explore technologies and strategies to further reduce the risk of transmitting CRBSIs to patients. Consequently, many facilities have implemented processes aimed at ensuring that all sterilization procedures and protocols are followed. Such processes may track all aspects of catheter care, including, for example, when catheter lines are accessed and when antiseptic caps are replaced. However, existing processes are generally recognized as time-consuming, duplicative, and / or error-prone, leading to inefficiencies and a decline in the overall standard of care within the facility.
[0007] Therefore, it would be desirable to provide an automated system and method for providing records related to catheter treatment and maintenance that shortens the amount of time required for such tasks and reduces the errors and inefficiencies associated therewith. The automated system and method would be capable of tracking catheter treatment maintenance tasks, including when a catheter line was accessed and when a disinfection cap was replaced. It would also be desirable to provide a detectable disinfection cap that could be used with such a system and method, thereby enabling monitoring of the connection / disconnection and replacement of the disinfection cap. Summary of the Invention
[0008] According to a non-limiting embodiment or aspect, an antiseptic cap engageable with a catheter connector is provided. The antiseptic cap can include a housing defining an internal cavity, the housing having a top wall, a multi-sided sidewall structure extending downwardly from the top wall and including a plurality of sidewall portions, and an open bottom end. The antiseptic cap also includes an antiseptic member configured to disinfect a portion of the catheter connector. Each of the plurality of sidewall portions includes a fiducial marker including a unique identifier for the antiseptic cap.
[0009] In some non-limiting embodiments or aspects, the fiducial marker is a marked data matrix that includes a unique identifier.
[0010] In some non-limiting embodiments or aspects, the fiducial marker includes an AprilTag that, when detected by an associated imaging device, provides location information regarding the disinfection cap, including the three-dimensional (3D) position and orientation of the disinfection cap relative to the imaging device.
[0011] In some non-limiting embodiments or aspects, fiducial markers are formed directly on each sidewall portion of the multi-sided sidewall structure via laser marked UV laser, continuous inkjet, or IR technology.
[0012] In some non-limiting embodiments or aspects, the plurality of sidewalls is between four and six sidewalls.
[0013] In some non-limiting embodiments or aspects, the plurality of side walls is five side walls, such that the housing has a pentagonal shape.
[0014] In some non-limiting embodiments or aspects, the housing is formed from a polymeric material that includes a color additive configured to enhance contrast marking of the fiducial markers.
[0015] In some non-limiting embodiments or aspects, each of the sidewalls includes a flat surface onto which fiducial markers are applied.
[0016] In some non-limiting embodiments or aspects, the multi-sided sidewall structure includes rounded or tapered edges between each pair of adjacent sidewalls.
[0017] In some non-limiting embodiments or aspects, the fiducial markers on the sidewalls are evenly spaced about the central axis of the housing.
[0018] In some non-limiting embodiments or aspects, the multi-sided sidewall structure includes a cylindrical, threaded interior surface configured to interlock with a mating feature of the catheter connector.
[0019] In some non-limiting embodiments or aspects, the housing includes an outer housing, and the antiseptic cap further includes an inner cap member disposed within the outer housing, the inner cap member including a threaded inner surface configured to interlock with a mating feature of the catheter connector.
[0020] In some non-limiting embodiments or aspects, the inner cap member is coupled to the outer housing via adhesive, laser welding, or snap features.
[0021] According to another non-limiting embodiment or aspect, there is provided a method for tracking the antiseptic cap described above. The method includes, using at least one processor, acquiring one or more images of a plurality of medical devices captured by an image capture device. The method also includes, using the at least one processor, determining, based on the one or more images, the presence of the antiseptic cap on the plurality of medical devices. The method further includes, using the at least one processor, determining, if the antiseptic cap is determined to be present on the plurality of medical devices based on the one or more images, position information associated with a three-dimensional (3D) position of the antiseptic cap relative to the image capture device. Still further, the method includes, using the at least one processor, determining, based on the determined presence and / or position information of the antiseptic cap, a status of the antiseptic cap.
[0022] In some non-limiting embodiments or aspects, determining the presence of antiseptic caps on the plurality of medical devices includes identifying a unique identifier for the antiseptic cap in one or more images.
[0023] In some non-limiting embodiments or aspects, determining position information associated with the 3D position of the disinfection cap relative to the image capturing device includes determining the 3D position of a fiducial marker on the disinfection cap relative to the image capturing device.
[0024] In some non-limiting embodiments or aspects, the one or more images are multiple images taken over a period of time.
[0025] In some non-limiting embodiments or aspects, determining the status of the antiseptic cap includes identifying replacement of the antiseptic cap with a new antiseptic cap based on the plurality of images.
[0026] In some non-limiting embodiments or aspects, upon identifying the replacement of the antiseptic cap with a new antiseptic cap, the method includes using at least one processor to identify IV lines of a plurality of medical devices accessed by the replacement of the antiseptic cap.
[0027] In some non-limiting embodiments or aspects, the method includes, upon identifying the accessed IV line, using at least one processor, providing an alert to flush the IV line.
[0028] In some non-limiting embodiments or aspects, determining the status of the antiseptic cap includes determining a dwell time for the antiseptic cap based on the plurality of images and providing, using at least one processor, an alert to replace the antiseptic cap.
[0029] According to another non-limiting embodiment or aspect, there is provided a system for tracking the above-described antiseptic cap, including an image capture device configured to capture images of an environment including a plurality of medical devices, and at least one processor programmed and / or configured to: acquire one or more images of the plurality of medical devices captured by the image capture device, determine a presence of an antiseptic cap on the plurality of medical devices based on the one or more images, determine position information associated with a three-dimensional (3D) position of the antiseptic cap relative to the image capture device if it is determined that an antiseptic cap is present on the plurality of medical devices based on the one or more images, and determine a status of the antiseptic cap based on the determined presence and / or position information of the antiseptic cap. [Brief explanation of the drawings]
[0030] Additional advantages and details are described in more detail below with reference to exemplary embodiments illustrated in the accompanying schematic drawings.
[0031] [Figure 1A] FIG. 1 illustrates non-limiting embodiments or aspects of environments in which the systems, devices, products, apparatuses, and / or methods described herein may be implemented. [Figure 1B] FIG. 1 illustrates a non-limiting embodiment or aspect of one implementation of an environment in which the systems, devices, products, apparatuses, and / or methods described herein may be implemented. [Figure 2] 1A and 1B illustrate non-limiting embodiments or aspects of one or more devices and / or components in one or more systems. [Figure 3A] 1 is a perspective view illustrating an implementation of a non-limiting embodiment or aspect of a medical device. [Figure 3B] 3B is a perspective view showing interconnected implementations of non-limiting embodiments or aspects of the medical device in FIG. 3A. [Figure 4A] FIG. 10 is a front top perspective view of an antiseptic cap according to a non-limiting embodiment or aspect. [Figure 4B] FIG. 4B is a front underside perspective view of the antiseptic cap of FIG. 4A. [Figure 4C] FIG. 4B is an exploded perspective view showing the antiseptic cap of FIG. 4A. [Figure 5A] FIG. 10 is a front top perspective view of an antiseptic cap according to a non-limiting embodiment or aspect. [Figure 5B] FIG. 5B is a front underside perspective view of the antiseptic cap of FIG. 5A. [Figure 5C] FIG. 5B is an exploded perspective view showing the antiseptic cap of FIG. 5A. [Figure 6] 10 is a flowchart illustrating a non-limiting embodiment or aspect of a process for tracking antiseptic caps. DETAILED DESCRIPTION OF THE INVENTION
[0032] It is to be understood that the present disclosure may contemplate various alternative configurations and modifications, unless expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the accompanying drawings, and described herein below, are merely exemplary and non-limiting embodiments or aspects. Hence, specific dimensions and other physical characteristics related to the embodiments or aspects disclosed herein are not to be considered as limiting.
[0033] For purposes of the following description, the terms "end," "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and derivatives thereof, shall refer to the embodiment or aspect as oriented in the drawings. However, it should be understood that an embodiment or aspect may assume various alternative variations and step sequences, unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely non-limiting example embodiments or aspects. Accordingly, specific dimensions and other physical characteristics related to the embodiments or aspects disclosed herein should not be considered limiting, unless otherwise indicated.
[0034] As used herein, any aspect, component, element, structure, operation, step, function, instruction, and / or the like should not be construed as critical or essential unless expressly stated as such. Also, as used herein, the articles "a" and "an" are intended to include one or more items and may be used interchangeably with "one or more" and "at least one." Furthermore, as used herein, the term "set" is intended to include one or more items (e.g., related items, unrelated items, a combination of related and unrelated items, etc.) and may be used interchangeably with "one or more" or "at least one." Where only one item is intended, the term "one" or similar language is used. Also, as used herein, the terms "has," "have," "having," or the like are intended to be open-ended terms. Furthermore, the phrase "based on" is intended to mean "based at least partially on," unless expressly stated otherwise.
[0035] As used herein, the terms “communication” and “communicate” may refer to receiving, accepting, sending, forwarding, providing, and / or the like, information (e.g., data, signals, messages, instructions, commands, and / or the like). For a unit (e.g., a device, a system, a component of a device or system, a combination thereof, and / or the like) to be in communication with another unit means that the unit can directly or indirectly receive information from and / or transmit information to the other unit. This may refer to a direct or indirect connection that is wired and / or wireless in nature. Furthermore, two units may be in communication with each other even if the transmitted information may be modified, processed, relayed, and / or optimally routed between the first and second units. For example, a first unit may be in communication with a second unit even if the first unit passively receives information and does not actively transmit it to the second unit. As another example, a first unit may be in communication with a second unit if at least one intermediary unit (e.g., a third unit located between the first unit and the second unit) processes information received from the first unit and transmits the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet containing data (e.g., a data packet, and / or the like). It will be appreciated that many other arrangements are possible.
[0036] As used herein, the term "computing device" may refer to one or more electronic devices configured to communicate directly or indirectly with one or more networks. A computing device may be a mobile or portable computing device, a desktop computer, a server, and / or the like. Furthermore, the term "computer" may refer to any computing device that includes components required for receiving, processing, and outputting data, typically including a display, a processor, memory, input devices, and a network interface. A "computing system" may include one or more computing devices or computers. An "application" or "application program interface" (API) refers to computer code or other data stored on a computer-readable medium. Such code or data may be executed by a processor to facilitate interaction between software components, such as a client-side front-end and / or a server-side back-end for receiving data from a client. An "interface" refers to a generated display, such as one or more graphical user interfaces (GUIs), with which a user may interact either directly or indirectly (e.g., through a keyboard, mouse, touchscreen, etc.). Furthermore, two or more computers, eg, servers, or other computerized devices communicating directly or indirectly in a network environment may constitute a "system" or a "computing system."
[0037] It will be apparent that the systems and / or methods described herein can be implemented in various forms, such as hardware, software, or a combination of hardware and software. The actual dedicated control hardware or software code used to implement these systems and / or methods is not a limitation of the implementation. Thus, although the operation and behavior of the systems and / or methods are described herein without reference to specific software code, it will be understood that software and hardware can be designed to implement the systems and / or methods based on the description herein.
[0038] Some non-limiting embodiments or aspects are described herein in relation to thresholds. As used herein, "meeting a threshold" can refer to a value being greater than the threshold, more than the threshold, higher than the threshold, equal to or greater than the threshold, less than the threshold, less than the threshold, less than the threshold, less than the threshold, less than the threshold, equal to or less than the threshold, etc.
[0039] 1A, which is a diagram illustrating an example of an environment 100 in which the devices, systems, methods, and / or products described herein may be implemented. As shown in FIG. 1A, the environment 100 includes user equipment 102, a management system 104, and / or a communication network 106. The systems and / or devices of the environment 100 may be interconnected via wired connections, wireless connections, or a combination of wired and wireless connections.
[0040] 1B, which illustrates a non-limiting embodiment or aspect of one implementation of an environment 100 in which the systems, devices, products, apparatus, and / or methods described herein may be implemented. For example, as shown in FIG. 1B, the environment 100 may include a hospital room including a patient, one or more medical devices 108, one or more fiducial markers 110 associated with the one or more medical devices 108, and / or a caregiver (e.g., a nurse, etc.). While the medical device 108 illustrated in FIG. 1B is provided as a device included in an IV catheter assembly, it will be recognized that the medical device 108 may be any of a number of medical devices associated with the care or treatment of a patient.
[0041] User equipment 102 may include one or more devices capable of receiving information and / or data from management system 104 (e.g., via communications network 106, etc.) and / or communicating information and / or data to management system 104 (e.g., via communications network 106, etc.). For example, user equipment 102 may include one or more computing systems (e.g., one or more computing devices, one or more server-based computers, one or more mobile computing devices, one or more tablet computers, etc.) including one or more processors. In some non-limiting embodiments or aspects, user equipment 102 may include a tablet computer or a mobile computing device, such as an Apple® iPad®, an Apple® iPhone®, an Android® tablet, an Android® smartphone, and / or the like.
[0042] User device 102 may include one or more image capture devices (e.g., one or more cameras, one or more sensors, etc.) configured to capture one or more images of an environment surrounding the one or more image capture devices (e.g., environment 100, etc.). For example, user device 102 may include one or more image capture devices configured to capture one or more images of one or more medical devices 108, one or more fiducial markers 110 associated with the one or more medical devices 108, and / or a patient. By way of example, user device 102 may include at least one of the following image capture devices: a camera, a stereo camera, a LiDAR sensor, or any combination thereof.
[0043] The management system 104 may include one or more devices capable of receiving information and / or data from the user equipment 102 (e.g., via the communications network 106, etc.) and / or communicating information and / or data to the user equipment 102 (e.g., via the communications network 106, etc.). For example, the management system 104 may include one or more computing systems (e.g., one or more computing devices, one or more server-based computers, one or more mobile computing devices, etc.) including one or more processors. In some non-limiting embodiments or aspects, the management system 104 includes and / or is accessible via a nursing station or terminal within a hospital. For example, the management system 104 may provide bedside nurse support, nursing station manager support, after-action reporting for nursing management, and / or the like.
[0044] The communication network 106 may include one or more wired and / or wireless networks. For example, the communication network 106 may include a cellular network (e.g., a long-term evolution (LTE) network, a third-generation (3G) network, a fourth-generation (4G) network, a fifth-generation (5G) network, a code division multiple access (CDMA) network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a telephone network (e.g., a public switched telephone network (PSTN), etc.), a private network, an ad hoc network, an intranet, the Internet, a fiber-optic-based network, a cloud-based computing network, and / or the like, and / or a combination of these or other types of networks.
[0045] The number and arrangement of systems and devices shown in Figures 1A and 1B are provided as examples. There may be additional, fewer, different, or differently arranged systems and devices than those shown in Figures 1A and 1B. Furthermore, two or more systems or devices shown in Figures 1A and 1B may be implemented within a single system or device, or the single system or device shown in Figures 1A and 1B may be implemented as multiple distributed systems or devices. Additionally or alternatively, a set of systems or devices (e.g., one or more systems, one or more devices, etc.) of environment 100 may perform one or more functions described as being performed by another set of systems or devices of environment 100.
[0046] 2, which is a diagram illustrating exemplary components in a device 200. The device 200 may correspond to the user equipment 102 (e.g., one or more devices in the system of user equipment 102, etc.) and / or one or more devices in the management system 104. In some non-limiting embodiments or aspects, the user equipment 102 (e.g., one or more devices in the system of user equipment 102, etc.) and / or one or more devices in the management system 104 may include at least one device 200 and / or at least one component of the device 200. As shown in FIG. 2, the device 200 may include a bus 202, a processor 204, a memory 206, a storage component 208, an input component 210, an output component 212, and a communication interface 214.
[0047] The bus 202 may include components that enable communication between the components of the device 200. In some non-limiting embodiments or aspects, the processor 204 may be implemented in hardware, software, or a combination of hardware and software. For example, the processor 204 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform a function (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), etc.). The memory 206 may include random access memory (RAM), read-only memory (ROM), and / or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and / or instructions used by the processor 204.
[0048] The storage component 208 may store information and / or software related to the operation and use of the device 200. For example, the storage component 208 may include a hard disk (e.g., a magnetic disk, optical disk, magneto-optical disk, solid-state disk, etc.), a compact disk (CD), a digital versatile disk (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium along with a corresponding drive.
[0049] Input components 210 may include components (e.g., a touchscreen display, a keyboard, a keypad, a mouse, buttons, switches, a microphone, etc.) that enable device 200 to receive information, such as through user input. Additionally or alternatively, input components 210 may include sensors for detecting information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, etc.). Output components 212 may include components (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), etc.) that provide output information from device 200.
[0050] Communications interface 214 includes transceiver-like components (e.g., a transceiver, a separate receiver and transmitter, etc.) that enable device 200 to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. Communications interface 214 may enable device 200 to receive information from and / or provide information to other devices. For example, communications interface 214 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi interface, a cellular network interface, and / or the like.
[0051] Device 200 may perform one or more processes described herein. Device 200 may perform these processes based on processor 204 executing software instructions stored by a computer-readable medium, such as memory 206 and / or storage component 208. Computer-readable media (e.g., non-transitory computer-readable media, etc.) are defined herein as non-transitory memory devices. A memory device includes memory space located within a single physical storage device or memory space spread across multiple physical storage devices.
[0052] Software instructions may be loaded into memory 206 and / or storage component 208 from other computer-readable media or from other devices via communication interface 214. When executed, the software instructions stored in memory 206 and / or storage component 208 may cause processor 204 to perform one or more processes described herein. Additionally or alternatively, hard-wired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. As such, embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.
[0053] The memory 206 and / or storage component 208 may include data storage or may include one or more data structures (e.g., databases, etc.). The device 200 may be capable of receiving information from, storing information to, communicating information to, or retrieving information stored in the data storage or one or more data structures in the memory 206 and / or storage component 208.
[0054] The number and arrangement of components shown in Figure 2 are provided as an example. In some non-limiting embodiments or aspects, device 200 may include additional, fewer, different, or differently arranged components than those shown in Figure 2. Additionally or alternatively, a set of components (e.g., one or more components) of device 200 may perform one or more functions described as being performed by another set of components in device 200.
[0055] 1B and the environment 100 depicted therein, including medical devices 108 and fiducial markers 110 associated with the care of a patient, it is recognized that a medical device 108 may be introduced into the environment 100 (e.g., via a caregiver, etc.), may reside within the environment 100 for a period of time (or indefinitely), may move within the environment 100, may interact (e.g., connect, disconnect, etc.) with one or more other medical devices 108, the patient, and / or caregiver, and / or may exit the environment 100 at a later point after having been introduced into the environment 100 (e.g., via a caregiver, etc.). The medical device 108 may include a disposable medical device or a reusable medical device. For example, the medical device 108 may include at least one of the following types: A catheter may be a peripheral IV catheter (PIVC), a peripherally inserted central venous catheter (PICC), a midline catheter, a central venous catheter (CVC), a needleless connector, a catheter dressing, a catheter stabilization device, an antiseptic cap, an IV tubing set, an extension set, a Y-connector, a stopcock, an infusion pump, a flush syringe, a drug delivery syringe, an IV fluid bag, a lumen adapter (e.g., the number of lumen adapters associated with a catheter may indicate the number of lumens included in the catheter), or any combination thereof. Figures 3A and 3B illustrate the arrangement of medical devices 108 (in a disconnected state (Figure 3A) and a connected state (Figure 3B)) according to non-limiting embodiments, each of the medical devices 108 including one or more fiducial markers 110. The medical devices 108 may collectively define an IV catheter assembly that may administer fluids to or withdraw fluids from a patient (i.e., draw blood).
[0056] Fiducial markers 110 (e.g., tags, labels, codes, etc.) may be associated with (e.g., removably attached, permanently attached, integrated, mounted, etc.) medical devices 108. In some non-limiting embodiments or aspects, each medical device 108 in the environment 100 may be associated with a fiducial marker 110. In some non-limiting embodiments or aspects, only a portion of the medical devices 108 in the environment 100 may be associated with a fiducial marker 110.
[0057] The fiducial marker 110 may encapsulate an identifier associated with the type of medical device 108 associated with the fiducial marker 110 and / or uniquely identify the medical device 108 associated with the fiducial marker 110 from other medical devices. For example, the fiducial marker 110 may encapsulate an identifier associated with at least one of the following types of medical device and / or uniquely identify the medical device 108 (e.g., a first needleless connector, a disinfectant cap, etc.) from other medical devices (e.g., a second needleless connector, etc.) that include an identifier associated with the same type of medical device: a peripherally inserted central catheter (PIVC), a peripherally inserted central catheter (PICC), a midline catheter, a central venous catheter (CVC), a needleless connector, a disinfectant cap, a disinfectant swab or wipe, an IV tubing set, an extension set, a Y-connector, a stopcock, an infusion pump, a flush syringe, a medication delivery syringe, an IV fluid bag, or any combination thereof.
[0058] Fiducial marker 110 may encapsulate pose information associated with the 3D position of fiducial marker 110. For example, fiducial marker 110 may include markings that, when captured in an image, allow for calculation of the fiducial marker's precise 3D position relative to the image capture device that captured the image (e.g., the fiducial marker's x-coordinate position, y-coordinate position, z-coordinate position, etc.) and / or the fiducial marker's precise 2D position within the image itself (e.g., the fiducial marker's x-coordinate position, y-coordinate position, etc.)
[0059] In some non-limiting embodiments or aspects, the fiducial marker 110 may include an AprilTag. For example, the fiducial marker 110 may include an AprilTag V3 of type customTag 48h12. This allows AprilTag V3 detection to be used to determine a unique ID that may indicate the type of medical device 108 associated with the fiducial marker (e.g., in leading digits, etc.), and / or the unique serial number of the particular medical device 108 (e.g., in trailing digits, etc.), and / or the location of the fiducial marker 110 within the field of view (FOV) of the imaging device (e.g., x-coordinate, y-coordinate, z-coordinate, Z-axis, Y-axis, X-axis direction vector, etc.). However, non-limiting embodiments or aspects include, but are not limited to, a QR code (registered trademark), a barcode (e.g., a 1D barcode, a 2D barcode, etc.), an Aztec (registered trademark) code, a Data Matrix code, an ArUco (registered trademark) marker, a color pattern, a reflective pattern, a fluorescent pattern, a predetermined shape and / or color (e.g., a red pentagon, a blue hexagon, etc.), an LED pattern, a hologram, and / or the like, which encapsulates an identifier associated with the type of medical device 108 associated with the reference marker 110, uniquely identifies the medical device 108 associated with the reference marker 110 from other medical devices, and / or encapsulates pose information associated with the 3D position of the reference marker 110.
[0060] In some non-limiting embodiments or aspects, the fiducial marker 110 may include a color calibration region located adjacent to the variable color region to calibrate color over a wider range of lighting conditions. For example, for a 2x2 grid, cell (1,1) in the upper left corner of the grid may include a predetermined and / or standard calibration color region (e.g., neutral gray, etc.), and the user device 102 and / or management system 104 may use the predetermined and / or standard calibration color region to calibrate colors in images to detect or identify the fiducial marker 110 in those images and / or to detect or identify color changes in patient tissue (e.g., patient tissue adjacent an insertion site, etc.) in those images. In such an example, the user device 102 and / or management system 104 may use predetermined and / or standard calibration color regions to adjust the orientation of the fiducial marker 110 and determine how to properly rotate and decode the colors within the fiducial marker 110 to decode an identifier encapsulated by the fiducial marker 110 and / or track the fiducial marker 110 within the environment 100.
[0061] 4 and 5 show exemplary medical devices 108 including fiducial markers 110 thereon, illustrating various embodiments of antiseptic caps 400, 500, in accordance with aspects of the present disclosure. As will be described in further detail below, the inclusion of fiducial markers 110 on the antiseptic caps 400, 500 in FIGS. 4 and 5 provides for monitoring of the positioning, usage, and / or status of the antiseptic cap, including, by way of example, removal / replacement of the antiseptic cap from a needleless access connector (NAC) on an IV line.
[0062] Referring initially to FIGS. 4A through 4C, an antiseptic cap 400 according to one embodiment of the present disclosure is shown. The antiseptic cap 400 is generally configured to mate with a luer connector (e.g., a female luer connector, etc.) of a needleless access connector (NAC) 108a (see FIGS. 3A and 3B) provided as part of an IV catheter assembly, as illustrated schematically in FIGS. 3A and 3B. As one example, the antiseptic cap 400 is configured to mate with a Becton Dickinson SmartSite® NAC. The antiseptic cap 400 includes a housing 402 within which is disposed an absorbent antiseptic member 404 having an antiseptic solution contained therein that is configured to disinfect portions of the NAC 108a. That is, the antiseptic member 404 is configured to disinfect the surfaces of the NAC 108a, including the threaded exterior surface of the female luer connector, to prevent the introduction of microorganisms and minimize the possibility of CRBSI.
[0063] 4A-4C , the housing 402 of the antiseptic cap 400 may generally include a top wall 406, a sidewall structure 408, and a bottom flange 410 that defines an open bottom end 412 of the housing. The housing 402 is configured such that the top wall 406 and the sidewall structure 408 collectively define or form an interior cavity 414 of the housing 402, and the open bottom end 412 of the housing 402 presents an opening to the cavity 414 that provides for positioning of the female luer connector of the NAC 108a within the cavity 414. The housing 402 may be formed as a single, integral structure that may be easily manufactured. For example, the housing 402 may be formed from a thermoplastic polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene, such that, according to some embodiments, the housing 402 may be formed via an injection molding process.
[0064] The sidewall structure 408 of the housing 402 includes an inner surface 416 that is cylindrically shaped to provide for reception of the female luer connector of the NAC 108a therein. The inner surface 416 is configured as a threaded inner surface that engages and interlocks with the threaded outer surface or segment of the female luer connector of the NAC 108a. To secure the antiseptic cap 400 to the NAC, the antiseptic cap 400 is twisted relative to the NAC 108a such that the corresponding threaded surfaces engage and draw the NAC 108a together against the antiseptic cap 400.
[0065] The disinfecting member 404 is disposed within the cavity 414 and is held in an upper portion of the cavity 414 such that the disinfecting member 404 is disposed adjacent to the top wall 406 of the housing 402 and may extend downward to fill a portion of the cavity 414. In some embodiments, the disinfecting member 404 may be held in place within the cavity 414 via contact with the threaded inner surface 416 of the sidewall structure 408, with the threads on the sidewall structure 408 maintaining the disinfecting member 404 under radial compression. The disinfecting member 404 may be formed from an absorbent material, such as a porous foam (e.g., open-cell foam, etc.) or a sponge, that can absorb a cleaning or disinfecting solution for cleaning and / or disinfecting portions of the NAC 108a. The disinfecting member 404 may be coated (i.e., pre-soaked) with a cleaning or disinfecting solution, which may be antibacterial, antifungal, antibacterial, or antiviral, to disinfect the surface of the NAC 108a. In some examples, the cleaning fluid can be isopropyl alcohol (IPA), such as about 70% IPA. In other examples, the cleaning fluid can be about 0.5% to about 3.5% chlorhexidine gluconate combined with about 70% IPA. Because the antiseptic member 404 is formed from a porous foam, sponge, or other elastomeric material, the antiseptic member 404 can be configured as a compressible member. Thus, when the antiseptic cap 400 mates with the female connector of the NAC 108a, the NAC 108a can compress the antiseptic member 404 as it is drawn into the cavity 414 via the engagement of the threaded outer surface of the NAC 108a with the threaded inner surface of the antiseptic member 416 of the housing 402. Compression of the antiseptic member 404 releases the cleaning or antiseptic fluid from the antiseptic member 404. It is recognized that the amount of disinfecting solution released from the disinfecting member 404 can be controlled based on the amount the disinfecting member 404 is compressed (based on the initial height / thickness of the disinfecting member 404) and the amount of cleaning or disinfecting solution contained therein that is contacting the portion of the NAC to disinfect therein.
[0066] According to aspects of the present disclosure, the outer surface 418 of the sidewall structure 408 of the housing 402 is formed as a multi-sided sidewall structure including a plurality of sidewall portions 420. In the illustrated embodiment, the multi-sided sidewall structure 408 includes five sidewall portions 420 that generally define the pentagonal sidewall structure 408, although it is recognized that the multi-sided sidewall structure 408 may alternatively include a fewer or greater number of sidewall portions 420, such as, by way of non-limiting example, four sidewall portions 420 (a square sidewall structure) or six sidewall portions 420 (a hexagonal sidewall structure). Each of the sidewall portions 420 may have tapered or rounded side edges 422 to provide a smooth transition between adjacent sidewall portions 420. Additionally, the top of each sidewall portion 420 may have an arcuate profile, with the top wall 406 of the housing 402 sloping downward to the sidewall portion 420 .
[0067] 4A-4C , each of the sidewall portions 420 includes a fiducial marker 110 thereon. As described above, the fiducial markers 110 may be provided in any of a number of suitable formats, such as AprilTag, QR code, barcode (e.g., 2D barcode, etc.), Aztec code, Data Matrix code, ArUco marker, color pattern, reflective pattern, fluorescent pattern, predetermined shape and / or color (e.g., red pentagon, blue hexagon, etc.), LED pattern, hologram, and / or the like. In the illustrated embodiment, each of the fiducial markers 110 is provided as a 2D detectable data matrix marked directly on the housing 402, such as via laser marking UV laser, continuous inkjet, or IR technology. In some embodiments, a color additive may be added to the polymeric material from which the housing 402 is formed to enhance the contrast marking of the fiducial markers 110. The fiducial markers 110 are marked on the side wall portion 420 so as to be symmetrically and evenly spaced around the central axis 424 of the antiseptic cap 400, thereby allowing at least one fiducial marker 110 to be presented in the FOV of the image capturing device 102 (Figures 1A and 1B) regardless of the orientation of the antiseptic cap 400, to improve recognition and ease of use of the markers.
[0068] 5A-5C, an antiseptic cap 500 according to another embodiment of the present disclosure is shown. Similar to the antiseptic cap 400, the antiseptic cap 500 is generally configured to mate with a luer connector (e.g., a female luer connector, etc.) of a NAC 108a, such as, for example, a Becton Dickinson SmartSite® NAC. The antiseptic cap 500 is configured to disinfect portions of the NAC 108a (e.g., the threaded exterior surface of the female luer connector, etc.) to prevent the introduction of microorganisms and minimize the possibility of CRBSI.
[0069] 5A-5C, the antiseptic cap 500 includes an outer cap housing 502, an inner cap member 504, and an absorbent antiseptic member 506 having an antiseptic solution contained therein. The inner cap member 504 and the absorbent antiseptic member 506 may be provided as standard-type caps, with the inner cap member 504 being provided as a generally cylindrical member including a top wall 508, a side wall 510, and a bottom flange 512 that defines an open bottom end 514 of the inner cap member 504. The inner cap member 504 is configured such that the top wall 508 and the side wall 510 collectively define or form an internal cavity 516 of the inner cap member 504 in which the antiseptic member 506 is disposed, and the open bottom end 514 of the inner cap member 504 presents an opening that provides for placement of the female luer connector of the NAC 108a therein. The sidewall 510 of the inner cap member 504 includes a threaded inner surface 518 that engages and interlocks with the threaded outer surface or segment of the female luer connector of the NAC 108a.
[0070] The antiseptic member 506 is disposed within the cavity 516 and is held in an upper portion of the cavity 516 such that the antiseptic member 506 is disposed adjacent to the top wall 508 of the inner cap member 504 and may extend downward to fill a portion of the cavity 516. As described above, the antiseptic member 506 may be formed from an absorbent material, such as a porous foam (e.g., open-cell foam, etc.) or a sponge, that can absorb a cleaning or disinfecting solution for cleaning and / or disinfecting portions of the NAC 108a. The antiseptic member 506 may be coated (i.e., pre-soaked) with a cleaning or disinfecting solution, which may be an antibacterial, antifungal, antibacterial, or antiviral solution that sanitizes the surface of the NAC 108a. When the antiseptic cap 500 mates with the female connector of the NAC 108a, the NAC 108a may compress the antiseptic member 506. Compression of the sanitizing member 506 releases cleaning or disinfecting fluid from the sanitizing member 506 to disinfect the NAC 108a.
[0071] According to aspects of the present disclosure, the outer cap housing 502 may be provided as a separate component from the inner cap member 504 and joined to the inner cap member 504 so as to be disposed above the inner cap member 504. The outer cap housing 502 includes a top wall 520 and a multi-sided sidewall structure 522 that collectively defines a cavity 524 having an open bottom end 526. In the illustrated embodiment, the multi-sided sidewall structure 522 includes five sidewall portions 528 that collectively define the pentagonal sidewall structure 522. However, it will be recognized that the multi-sided sidewall structure 522 may alternatively include a fewer or greater number of sidewall portions 528, such as, by way of non-limiting example, four sidewall portions 528 (a square sidewall structure) or six sidewall portions 528 (a hexagonal sidewall structure). Each sidewall portion 528 may have a tapered or rounded side edge 530 to provide a smooth transition between adjacent sidewall portions 528 .
[0072] 5A-5C , the outer cap housing 502 is configured such that the cavity 524 defined thereby (i.e., based on the height and perimeter of the multi-sided sidewall structure 522) is large enough to accommodate the inner cap member 504 therein. In some embodiments, the cavity 524 is sized such that the inner cap member 504 is disposed within the outer cap housing 502 such that the bottom flange 512 of the inner cap member 504 seats against the lip portion 532 of the multi-sided sidewall structure 522, causing the bottom flange 512 to be flush with the bottom edge 534 of the multi-sided sidewall structure 522. According to an embodiment, the inner cap member 504 may be permanently secured within the outer cap housing 502 or may be secured in a manner that provides for selective removal of the outer cap housing 502 from the inner cap member 504. In embodiments in which the inner cap member 504 and the outer cap housing 502 are permanently secured to one another, the outer cap housing 502 may be glued or laser welded to the inner cap member 504. In embodiments in which the outer cap housing 502 may be selectively detachable from the inner cap member 504, the outer cap housing 502 and the inner cap member 504 may be coupled via one or more snap features 536 formed on the lip portion 532 and / or the inner surface of the multi-layer sidewall structure 522.
[0073] As described above with respect to the antiseptic cap 400, each of the sidewall portions 528 of the multi-wall sidewall structure 522 on the outer cap housing 502 may include fiducial markers 110 thereon, and in the illustrated embodiment, each of the fiducial markers 110 is shown provided as a 2D detectable data matrix marked directly on the outer cap housing 502, such as via laser-marked UV laser, continuous inkjet, or IR technology. The fiducial markers 110 are marked on the sidewall portions 528 so as to be symmetrically and evenly spaced about the central axis 538 of the antiseptic cap 500, which may allow at least one fiducial marker 110 to be presented in the FOV of the image capture device 102 (FIGS. 1A and 1B) regardless of the orientation of the antiseptic cap 500, to enhance marker recognition and ease of use.
[0074] Referring now to FIG. 6, a flowchart of a method 600 for vascular access management is shown, according to a non-limiting embodiment or aspect of the present disclosure. In particular, method 600 is directed to tracking antiseptic caps 400, 500 as shown and described in FIGS. 4 and 5. In some non-limiting embodiments or aspects, one or more of the steps of process 400 may be performed (e.g., fully, partially, etc.) by user device 102 (e.g., one or more devices of a system of user device 102, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 400 may be performed (e.g., fully, partially, etc.) by another device or devices separate from or including user device 102, such as management system 104 (e.g., one or more devices of management system 104, etc.).
[0075] As shown in FIG. 6 , in step 602, process 600 includes acquiring one or more images. For example, the user device 102 (i.e., its image capture device) may acquire images (e.g., a single image, multiple images, a series of images, etc.) of multiple medical devices 108, such as may be included in an IV catheter assembly, including one or more antiseptic caps 400, 500 attached to the NAC of the IV catheter assembly. As an example, the image capture device of the user device 102 may capture images of multiple medical devices 108, including one or more antiseptic caps 400, 500. In such an example, a nurse may use the user device 102 to capture one or more images of a patient's catheter site, including multiple medical devices 108 (i.e., an IV catheter assembly), including one or more antiseptic caps 400, 500, as shown schematically in FIG. 1B . In some non-limiting embodiments or aspects, the nurse may capture a series of images over a period of time, such as capturing one or more images of multiple medical devices 108 and antiseptic caps during each of multiple shifts worked by the nurse.
[0076] As shown in FIG. 6 , in step 604, the process 600 includes identifying multiple medical devices 108 of an IV catheter assembly, including determining the presence of antiseptic caps 400, 500 within the medical devices. For example, the user device 102 and / or management system 104 may determine, based on the images, the types of medical devices 108 within the environment over a period of time and / or specific medical devices within the environment, including identifying unique antiseptic caps 400, 500 within the environment. In identifying the multiple medical devices 108, the user device 102 may determine or identify, based on the images, multiple fiducial markers 110 associated with the medical devices 108. For example, the multiple fiducial markers 110 may include multiple AprilTags, and the user device 102 may process the images using AprilTag detection software to determine the type of medical device 108 associated with the fiducial markers 110 and / or a unique serial number for the specific medical device 108. For antiseptic caps 400, 500, the fiducial markers 110 thereon may include multiple AprilTags, and the user device 102 may process the image using AprilTag detection software to identify the unique serial number of the antiseptic cap 400, 500. Thus, in step 604, the presence of a particular antiseptic cap 400, 500 among the multiple medical devices 108 may be quickly identified by the user device 102 and / or management system 104.
[0077] 6, in step 606, the process 600 includes determining the positions, trajectories, and / or orientations (i.e., "position information") of the plurality of medical devices 108, including the antiseptic caps 400, 500, as well as the positions of the plurality of medical devices 108 over a period of time, the trajectories of the plurality of medical devices 108 within the environment over a period of time, and / or the orientations of the plurality of medical devices 108 within the environment over a period of time. For example, the user device 102 and / or the management system 104 may determine, based on the image, position information associated with the 3D positions of the plurality of medical devices 108 (including the antiseptic caps 400, 500) relative to the image-capturing device and / or the 2D positions of the medical devices 108 in the image itself. That is, based on the image, the user device 102 may determine or identify the fiducial markers 110 associated with the medical devices and pose information associated with the 3D and / or 2D positions of the fiducial markers 110 to determine position information associated with the 3D positions of the medical devices 108 relative to the image-capturing device and / or the 2D positions of the medical devices 108 in the image itself. For example, the fiducial markers 110 may include AprilTags, and the user device 102 may process the image using AprilTag detection software to calculate the precise 3D positions, orientations, and / or IDs of the fiducial markers 110 relative to the image-capturing device that captured the image and / or the precise 2D positions of the fiducial markers 110 in the image itself. For each medical device 108, the 3D positions of the fiducial markers 110 associated with that medical device relative to the image-capturing device may include the x-, y-, and z-coordinates of the fiducial marker 110 and / or the direction vector of the fiducial marker 110 relative to the z-, y-, and x-axes. In such an example, for each medical device 108 in the first medical device group, the 2D position of the fiducial marker 110 in the image itself may include the x-coordinate, y-coordinate, and / or the directional vector relative to the y-axis, x-axis of the fiducial marker.
[0078] 6, in step 608, the process 600 includes determining the status of antiseptic caps 400, 500 present on multiple medical devices 108. For example, the user device 102 and / or management system 104 may determine the status of the antiseptic caps 400, 500 based on the presence of a particular antiseptic cap 400, 500 and / or location information of the antiseptic cap 400, 500. The status of the antiseptic cap 400, 500 may include various uses of the antiseptic cap 400, 500, including connecting / disconnecting the antiseptic cap 400, 500 to one or more medical devices 108 (i.e., the NAC 108a), replacing the antiseptic cap 400, 500 with a new antiseptic cap 400, 500, and / or which IV lines in an IV catheter assembly have been accessed, as well as the association of the antiseptic cap 400, 500 with other medical devices 108.
[0079] In one non-limiting embodiment or aspect, the user device 102 and / or management system 104 may compare a first image of the plurality of medical devices 108 and antiseptic caps 400, 500 taken by a nurse during a first shift to a second image of the plurality of medical devices 108 and antiseptic caps 400, 500 taken by a nurse during a second shift to identify whether the antiseptic caps 400, 500 have been replaced with new antiseptic caps 400, 500. In each image, the user device 102 and / or management system 104 may determine or identify the particular antiseptic cap 400, 500 used in the IV catheter assembly via identification of the fiducial markers 110 associated with the antiseptic caps 400, 500. Thus, if a particular disinfection cap 400, 500 is identified in a first image (via its unique reference marker 110) and the same disinfection cap 400, 500 is no longer present in a second image, and instead a new disinfection cap 400, 500 is identified in the second image (via its unique reference marker 110) in the position where the old disinfection cap 400, 500 was identified, the user device 102 and / or management system 104 may determine that a cap replacement has occurred.
[0080] In one non-limiting embodiment or aspect, when the user device 102 and / or the management system 104 determines / identifies that the antiseptic cap 400, 500 is being replaced with a new antiseptic cap 400, 500, the user device 102 and / or the management system 104 may determine or identify the IV line (among the multiple medical devices 108) that was accessed during the replacement of the antiseptic cap 400, 500. In identifying the accessed IV line, the user device 102 may process location information of the multiple medical devices 108 and / or the type of the multiple medical devices 108 to determine which IV line the old / new antiseptic cap 400, 500 was / is connected to. As described above, using AprilTag provided on the fiducial markers 110 on the medical device 108, the user device 102 can process the image using AprilTag detection software to calculate the precise 3D position, orientation, and / or ID of the multiple fiducial markers 110 relative to the image capture device that captured the image, and / or the precise 2D position of the multiple fiducial markers 110 in the image itself, thereby enabling association of the identified antiseptic cap 400, 500 with the IV line (and NAC 108a) to which it is connected.
[0081] In one non-limiting embodiment or aspect, in connection with identifying an IV line (among the medical devices 108) accessed by changing the antiseptic cap 400, 500, the user device 102 and / or management system 104 may be further configured or programmed to provide an alert or reminder to the nurse to flush the IV line. The alert may be a visual (e.g., text, etc.) or audible alert output by the user device 102, which enables adherence to proper sterilization protocols.
[0082] In yet other non-limiting embodiments or aspects, the user device 102 and / or management system 104, recognizing that the antiseptic caps 400, 500 may need to be replaced periodically, may determine a dwell time associated with the antiseptic caps 400, 500, i.e., the amount of time the same antiseptic cap 400, 500 is connected to its associated NAC 108a. If the dwell time exceeds a preset dwell time threshold, the user device 102 may issue an alert indicating it is time to replace the antiseptic cap 400, 500 with a new antiseptic cap 400, 500.
[0083] In yet other non-limiting embodiments or aspects, the user device 102 and / or management system 104 may identify antiseptic caps 400, 500 that have been disconnected from their associated medical devices 108 (i.e., NACs). The user device 102 may process location information for multiple medical devices 108 and the types of multiple medical devices 108, including the locations and IDs of the antiseptic caps 400, 500, to identify disconnected antiseptic caps 400, 500 that may be floating around above a bed or patient in proximity to other tagged objects. If the distance between the antiseptic cap and other medical devices exceeds a preset threshold distance, the user device 102 automatically determines that the antiseptic cap 400, 500 is not connected to another medical device 108.
[0084] In yet other non-limiting embodiments or aspects, the user device 102 and / or management system 104 may store each image acquired by the user device 102 to document the on-site review performed by the nurse. By documenting and recording such on-site review, proper vascular access management practices, including proper maintenance of vascular access devices and adherence to sterilization protocols and procedures, may be quickly and efficiently verified.
[0085] Thus, advantageously, embodiments of the present invention provide a detectable antiseptic cap that can be implemented in a vascular access control system and method that enables tracking of the antiseptic cap and its associated tasks or procedures. The antiseptic cap includes multiple fiducial marks evenly spaced about its central axis that can be read / detected by the vascular access control system to uniquely identify the antiseptic cap, its position relative to an image capture device, and its position relative to other medical devices. Through tracking of the detectable antiseptic cap, cap changes and IV line access can be tracked, thereby generating reminders to flush IV lines to reduce the possibility of line blockage. Capturing images of the antiseptic cap and associated medical devices also allows for the creation of a photo log that can be reviewed over time, thereby enhancing documentation accuracy, compliance with VAM protocols, and the ability to provide future training for care improvement.
[0086] While embodiments or aspects have been described in detail for purposes of illustration and description, it should be understood that such details are for that purpose only and that the embodiments or aspects are not limited to the disclosed embodiments or aspects, but rather are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect. Indeed, many of these features can be combined in ways not specifically recited in the claims and / or disclosed in the specification. While each dependent claim listed below may depend directly on only one claim, the disclosure of possible implementations includes each dependent claim in combination with all other claims in the claim set.
Claims
1. 1. An antiseptic cap engageable with a catheter connector, comprising: A housing defining an interior cavity, a top wall; a multi-sided sidewall structure extending downwardly from the top wall, the multi-sided sidewall structure including a plurality of sidewall portions; Open bottom end and a housing including: a disinfecting member configured to disinfect a portion of the catheter connector; Equipped with each of the plurality of sidewall portions includes a fiducial marker thereon, the fiducial marker including a unique identifier for the antiseptic cap; cap.
2. The cap of claim 1 , wherein the fiducial marker comprises a marked data matrix containing the unique identifier.
3. The cap of claim 1, wherein the fiducial marker includes an AprilTag that, when detected by an associated image capturing device, provides positional information regarding the antiseptic cap, the positional information including a three-dimensional (3D) position and orientation of the antiseptic cap relative to the image capturing device.
4. The cap of claim 1 , wherein the fiducial markers are formed directly on each sidewall portion of the multi-sided sidewall structure via laser-marked UV laser, continuous inkjet, or IR technology.
5. The cap of claim 1 , wherein the plurality of side walls includes between four and six side walls.
6. The cap of claim 5 , wherein the plurality of side walls includes five side walls, such that the housing has a pentagonal shape.
7. The cap of claim 1 , wherein the housing is formed from a polymeric material including a color additive configured to enhance contrast marking of the fiducial marker.
8. The cap of claim 1 , wherein each of the side walls includes a flat surface on which the fiducial marker is provided.
9. The cap of claim 8 , wherein the multi-sided sidewall structure includes a rounded or tapered edge between each pair of adjacent sidewall portions.
10. The cap of claim 1 , wherein the fiducial markers on the side walls are evenly spaced about a central axis of the housing.
11. The cap of claim 1 , wherein the multi-sided sidewall structure includes a cylindrically threaded inner surface configured to interlock with a mating feature of the catheter connector.
12. 2. The cap of claim 1, wherein the housing includes an outer housing, and the antiseptic cap further includes an inner cap member disposed within the outer housing, the inner cap member including a threaded inner surface configured to interlock with a mating feature of the catheter connector.
13. The cap of claim 12 , wherein the inner cap member is coupled to the outer housing via adhesive, laser welding, or snap features.
14. 1. A method for tracking an antiseptic cap engageable with a catheter connector, comprising: providing an antiseptic cap comprising a housing defining an internal cavity, the housing including a top wall, a multi-sided sidewall structure extending from the top wall, the multi-sided sidewall structure including a plurality of sidewall portions, an open bottom end, and an antiseptic member configured to disinfect a portion of the catheter connector, each of the plurality of sidewall portions including a fiducial marker thereon, the fiducial marker including a unique identifier of the antiseptic cap; acquiring, with at least one processor, one or more images of the plurality of medical devices captured by an image capture device; determining, with at least one processor, the presence of the antiseptic cap on the plurality of medical devices based on the one or more images; using at least one processor, if the antiseptic cap is determined to be present within a plurality of medical devices based on the one or more images, determining position information associated with a three-dimensional (3D) position of the antiseptic cap relative to the image capture device; determining, with at least one processor, a status of the antiseptic cap based on the determined antiseptic cap presence and / or location information; A method comprising:
15. 15. The method of claim 14, wherein determining the presence of the antiseptic cap on the plurality of medical devices comprises identifying the unique identifier for the antiseptic cap in the one or more images.
16. 16. The method of claim 15, wherein determining the position information associated with the 3D position of the antiseptic cap relative to the image capture device comprises determining the 3D position of the fiducial marker of the antiseptic cap relative to the image capture device.
17. The method of claim 14 , wherein the one or more images comprise a plurality of images taken over a period of time.
18. 20. The method of claim 17, wherein determining the status of the antiseptic cap comprises identifying replacement of the antiseptic cap for a new antiseptic cap based on the plurality of images.
19. 20. The method of claim 18, further comprising, in identifying the replacement of the antiseptic cap with the new antiseptic cap, using the at least one processor to identify IV lines of the plurality of medical devices accessed by the replacement of the antiseptic cap.
20. 20. The method of claim 19, further comprising, upon identifying the accessed IV line, using the at least one processor, providing an alert to flush the IV line.
21. 20. The method of claim 17, wherein determining the status of the antiseptic cap includes determining a dwell time for the antiseptic cap based on the plurality of images, the method further comprising providing, with the at least one processor, an alert to replace the antiseptic cap.
22. 1. A system for tracking disinfection caps, comprising: an antiseptic cap engageable with a catheter connector, the antiseptic cap including a housing defining an internal cavity, a top wall, and a multi-sided sidewall structure extending from the top wall, the multi-sided sidewall structure including a plurality of sidewall portions, an open bottom end, and an antiseptic member configured to disinfect portions of the catheter connector, each of the plurality of sidewall portions including a fiducial marker therefor, the fiducial marker including a unique identifier of the antiseptic cap; an image capture device configured to capture an image of an environment including a plurality of medical devices; at least one processor, acquiring one or more images of the plurality of medical devices captured by the image capturing device; determining the presence of the antiseptic cap on the plurality of medical devices based on the one or more images; if the antiseptic cap is determined to be present within the plurality of medical devices, determining position information associated with a three-dimensional (3D) position of the antiseptic cap relative to the image capture device based on the one or more images; determining a status of the antiseptic cap based on the determined presence and / or location information of the antiseptic cap; at least one processor programmed and / or configured to perform A system comprising: