Vascular access device dwell assessment and archiving

Abstract

An artificial intelligence system can be used to gather vascular access data for training an AI model. An AI engine can use the AI model to automatically assess vascular access devices, including detecting indwelling events and conditions. The AI engine can generate a notification of any indwelling event or condition that it detects during an assessment. The AI engine can also archive any indwelling event or condition.

Description

Background Technology

[0001] Vascular access devices are commonly used in various infusion therapies. For example, vascular access devices can be used to infuse therapeutic agents or fluids into a patient. Vascular access devices can also be used to draw blood from a patient. Various vascular access devices are commonly used in medical settings, including, for example, peripherally inserted central venous catheters, midline catheters, central venous catheters, dialysis catheters, and arterial catheters.

[0002] A common type of vascular access device includes a catheter that covers a needle. As the name suggests, the catheter covers a needle and can be mounted on a guide needle with a sharp distal tip. The catheter and guide needle can be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, with the bevel of the needle facing upwards and away from the patient's skin. The catheter and guide needle are typically inserted into the patient's vascular system through the skin at a shallow angle. To verify proper placement of the guide needle and / or catheter in the vessel, clinicians generally confirm the presence of blood "backflow" in the blood return chamber of the catheter assembly. Once needle placement is confirmed, the catheter can remain in place for future blood draws or fluid infusions.

[0003] Figure 1A Examples of prior art vascular access devices 100 that can be used in implementing embodiments of the present disclosure are provided. Vascular access device 100 includes a catheter adapter 110 from which a catheter 111 extends. The catheter adapter 111 may also include a side port 112 through which an extension kit 114 is connected. Vascular access device 100 may also include a stabilizing platform 113 for stabilizing the catheter adapter 111 when positioned on a patient. Vascular access device 100 is merely one example of many vascular access devices that can be used in implementing embodiments of the present disclosure. For example, central venous catheters (CVCs), peripherally inserted central venous catheters (PICCs), midline catheters, arterial catheters, peripherally inserted venous catheters (PIVCs), long PIVCs, venous puncture devices, subcutaneous access devices, and other indwelling catheters, probes, sensors, or instruments may be used.

[0004] Although catheter placement performance (i.e., how long a catheter can be safely left in the vascular system) has improved in recent years, a number of potential complications still exist during the expected indwelling time of vascular access devices. These complications can include displacement, infiltration, extravasation, phlebitis, catheter-related infections, and loss of patency.

[0005] Different types of ultrasound instruments exist for monitoring catheters. For example, Figure 1B The illustration shows a prior art piezoelectric transducer array 10 (or ultrasound probe 10) for performing ultrasound. The ultrasound probe 10 is conformal and therefore can be worn on the skin and used to perform deep tissue imaging.

[0006] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0007] This disclosure generally relates to the evaluation and archiving of vascular access devices. Artificial intelligence systems can be used to collect vascular access data for training AI models. AI engines can use these models to automatically evaluate vascular access devices, including detecting indwelling events and conditions. The AI ​​engine can generate notifications of any indwelling events or conditions it detects during the evaluation process. The AI ​​engine can also archive any indwelling events or conditions.

[0008] In some embodiments, vascular access device assessment can be performed by an AI within the vascular access system. The AI ​​engine can receive vascular access data associated with a vascular access device having a catheter inserted into the patient's vascular system. The AI ​​engine can evaluate the vascular access data against an AI model to detect one or more indwelling events or conditions. The AI ​​engine can generate one or more notifications indicating the one or more indwelling events or conditions.

[0009] In some embodiments, vascular access data may include catheter imaging data.

[0010] In some embodiments, vascular access data may include sensor readings.

[0011] In some embodiments, evaluating vascular access data against an AI model to detect one or more indwelling events or conditions may include determining that the imaging data includes one or more features indicative of the one or more indwelling events or conditions.

[0012] In some embodiments, determining that imaging data includes one or more features indicative of one or more indwelling events or conditions may include matching the imaging data with labeled vascular access data on which an AI model has been trained.

[0013] In some embodiments, one or more notifications may be displayed in the vascular access system.

[0014] In some embodiments, a patient’s record may be updated to include one or more indwelling events or conditions.

[0015] In some embodiments, vascular pathway data can be used to update a labeled dataset from which an AI model has been trained.

[0016] In some embodiments, additional criteria may be considered when evaluating vascular access data against an AI model to detect one or more indwelling events or conditions.

[0017] In some embodiments, additional criteria may include one or more of the following: one or more policies; one or more standards; one or more safety factors; the patient’s medical history; or the patient’s disease or disease status.

[0018] In some embodiments, considering additional criteria may include evaluating one or more thresholds or limits to determine whether to generate one or more notifications.

[0019] In some embodiments, vascular access data can be received intermittently or continuously over a period of time.

[0020] In some embodiments, the data processor can receive data from other vascular pathway systems and generate labeled datasets from that data. A model trainer can then use the labeled datasets to train an AI model.

[0021] In some embodiments, other vascular access data may include imaging data of catheters inserted into the vascular system of other patients.

[0022] In some embodiments, the computer storage medium may store computer-executable instructions that, when executed, implement a method for performing vascular access device evaluation. An AI model may be maintained. Vascular access data may be received. The vascular access data may relate to a vascular access device having a catheter inserted into a patient's vascular system. The vascular access data may include imaging data of the catheter. The AI ​​model may be used to evaluate the catheter.

[0023] In some embodiments, using an AI model to evaluate a catheter may include determining from the AI ​​model vascular access data that indicates one or more indwelling events or conditions.

[0024] In some embodiments, one or more notifications may be generated for one or more indwelling events or conditions, and the one or more indwelling events or conditions may be archived in the patient's record.

[0025] In some embodiments, a vascular access system may include a vascular access device comprising a catheter, a monitoring component comprising an imaging device configured to be positioned above the catheter when the catheter is inserted into a patient’s vascular system, a base unit configured to receive vascular access data including imaging data from the monitoring component, and an AI engine configured to evaluate the vascular access data against an AI model to detect one or more indwelling events or conditions from the imaging data.

[0026] In some embodiments, the imaging device may be an ultrasound probe.

[0027] In some embodiments, the vascular access system may also include one or more monitoring devices for presenting one or more notifications related to one or more indwelling events or conditions.

[0028] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and are not restrictive of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and tools illustrated in the drawings. It should also be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made (unless otherwise stated) without departing from the scope of the various embodiments of the invention. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0029] The exemplary embodiments will be described and explained with additional specificity and detail using the accompanying drawings, in which: Figure 1A The illustrations depict prior art vascular access devices that may be used in one or more embodiments of this disclosure; Figure 1B The illustration shows a prior art piezoelectric transducer array used for performing ultrasound; Figure 2A The illustration shows a fixed platform that can be used in implementing one or more embodiments of the present disclosure; Figure 2B The illustration shows a vascular access system that can be used in implementing one or more embodiments of the present disclosure; Figure 3A The illustration shows another fixed platform that can be used in implementing one or more embodiments of this disclosure; Figure 3B The illustration shows another fixed platform that can be used in implementing one or more embodiments of this disclosure; Figure 4A The illustration shows another fixed platform that can be used in implementing one or more embodiments of this disclosure; Figure 4B The illustration shows the effect when used with vascular access devices. Figure 4A Fixed platform; Figure 4C The illustration shows the use of a fixation dressing to secure vascular access devices. Figure 4A Fixed platform; Figure 5A This is a block diagram of components of a vascular access system that can be used in implementing one or more embodiments of the present disclosure; Figure 5B It is a flowchart representing the continuity of nursing care; Figure 6AIt is a cross-sectional view of a vascular system that can be generated using a vascular access system; Figure 6B and Figure 6C It is by Figure 6A Example images generated from vascular access systems; Figure 7 Examples that can be generated by vascular access systems are shown; Figure 8 Examples of electronic components for a vascular access system base unit or monitoring device are provided; Figure 9A-10C Additional examples of vascular access systems that can be used in implementing one or more embodiments of this disclosure are provided; Figure 11A and Figure 11B Examples of vascular probe components that can form part of a vascular access system are provided; Figure 12A and Figure 12B Another example of a vascular probe assembly that can form part of a vascular access system is provided; and Figures 13A-13C Examples are provided of how vascular access device evaluation and archiving can be performed according to one or more embodiments. Detailed Implementation

[0030] In this specification and claims, the term "continuity of care" is intended to refer to the entire duration of vascular access, including pre-insertion, during insertion, indwelling duration, and post-removal. "Vascular access device" should be interpreted to encompass intravenous catheter devices and any other devices that can be used to access a patient's vascular system. "Vascular access data" should be interpreted to encompass any data related to access to a patient's vascular system using a vascular access device, and includes images of the patient's vascular system, characteristics of the vascular access device, information regarding the placement and / or removal of the vascular access device, information regarding events occurring during the indwelling period of the vascular access device, detected complications, the patient's vital signs, fluid and blood flow characteristics, etc.

[0031] Before describing how vascular access device indwelling assessment and archiving can be performed according to embodiments of this disclosure, various vascular access systems will be described. These, and any other suitable vascular access systems, can be used to facilitate vascular access device indwelling assessment and archiving according to embodiments of this disclosure.

[0032] Figure 2A An example of a fixed platform 200 configured for use with the vascular access device 100 is provided, which can be positioned below the vascular access device 100 during use, such as... Figure 2BAs shown in the diagram. The fixation platform 200 includes a base layer 201, which may have an adhesive bottom side to allow the fixation platform 200 to adhere to the patient's skin. The base layer 201 may also include a vascular access device pouch 202, the shape and size of which may generally match the stabilization platform 113. In some embodiments, the vascular access device pouch 202 may be an incision exposing the patient's skin, thereby allowing the stabilization platform 113 to be placed directly on the skin. In other embodiments, the vascular access device pouch 202 may be a portion of the base layer 201, the upper surface of which has an adhesive so that the stabilization platform 113 can adhere to the base layer 201.

[0033] The fixation platform 200 may also include a catheter insertion site window 203 positioned distal to the vascular access device pouch 202 to allow the catheter 111 to pass through the fixation platform 200 and enter the patient's vascular system when the catheter adapter 110 is positioned above the fixation platform 200. In some embodiments, the shape and size of the catheter insertion site window 203 may be determined to accommodate an antimicrobial patch or pad, or to enable the application and containment of a skin adhesive for sealing the insertion site. In some embodiments, a groove (not shown) may be formed in the base layer 201 and may extend between the catheter insertion site window 203 and the periphery of the base layer 201 to allow the fixation platform 200 to be positioned below the vascular access device 100 after insertion of the catheter 111.

[0034] The stabilization platform 200 also includes an imaging device pouch 204 positioned distal to the catheter insertion site window 203. The imaging device pouch 204 may be spaced from the catheter insertion site window 203 by a distance corresponding to the length of the catheter 111. In other words, the imaging device pouch 204 may be positioned above the distal tip of the catheter 111 when the catheter 111 is inserted into the vascular system and the stabilization platform 113 is positioned within the vascular access device pouch 202. In some embodiments, the imaging device pouch 204 may be an incision exposing the patient's skin. In other embodiments, the imaging device pouch 204 may be formed from a gel cap to facilitate imaging. The size and shape of the imaging device pouch 204 may be selected to accommodate a range of imaging device head shapes and orientations, including rectangular, square, or other shapes extending laterally and / or longitudinally. Figure 2B Two examples of imaging devices 210 that can be used when intermittent monitoring is desired are shown.

[0035] In some embodiments, the imaging device pouch 204 may be at least partially surrounded by the guide 205. In some embodiments, the guide 205 may be raised from the base layer 201 to form a wall around the imaging device pouch 204. The guide 205 may facilitate controlled adjustment of the imaging device 210 when positioned within the imaging device pouch 204, such as controlling probe angles or rotations across multiple degrees of freedom (e.g., of an ultrasound probe).

[0036] In some embodiments where the imaging device pouch 204 includes a gel cap, the gel cap may be a disposable, stand-alone device integrated into the anchoring platform 200. In other embodiments, the gel cap may be attached to a patient or imaging device 210 for easy access when used within the imaging device pouch 204. In some embodiments, the gel cap may have antibacterial properties to allow the imaging device pouch 204 to remain clean during multiple uses of the imaging device 210. In some embodiments, the gel cap may be configured to be rehydrated, allowing it to be reused multiple times within the imaging device pouch 204.

[0037] Figure 3 provides an example in which the fixation platform 200 is formed by two separate components 200a and 200b. Component 200a includes a vascular access device pouch 202 and a catheter insertion site window 203, while component 200b includes an imaging device pouch 204. This two-component configuration of the fixation platform 200 can be used to accommodate catheters 111 of different lengths, such as for long peripheral venous catheters and midline catheters. In some embodiments, component 200b may have an extended base layer 201 to facilitate adhesion of component 200b to the patient's skin.

[0038] Figure 3A An example is also provided in which the fixation platform 200 includes a fixation dressing 300, which is placed above the fixation platform 200 (in this case above component 200a) to secure the vascular access device 100 in place relative to the fixation platform 200. The fixation dressing 300 may include a layer 301 whose shape and size are determined to match the proximal end of the fixation platform 200 (e.g., to match the size and shape of component 200a). Layer 301 may include a transparent window 303 aligned with / overlapping with the catheter insertion site window 203 to facilitate viewing of the insertion site. In some embodiments, the transparent window 303 may be aligned with / overlapping with at least a portion of the vascular access device pouch 202 to facilitate viewing of the catheter adapter 110. Layer 301 may also include a boundary 302. In some embodiments, the underside of the boundary 302 may include an adhesive for securing the fixation dressing 300 to the fixation platform 200. In some embodiments, a groove 304 may be formed in the boundary 302 to allow the extension kit 114 to pass through the fixation dressing 300. Figure 3B and Figure 3AThe same applies, but it shows that component 200b can be positioned longitudinally relative to conduit 111.

[0039] In some embodiments, the fixation platform 200 may consist of only component 200b. In such embodiments, the fixation platform 200 may be properly positioned to ensure that the imaging device bag 204 is positioned above the distal tip of the conduit 111.

[0040] Figures 4A-4C Another example of a fixation platform 200 is provided, which is configured for use with a vascular access device 100 of different configurations, which is a non-integrated vascular access device. These figures illustrate how the vascular access device pouch 202, catheter insertion site window 203, and imaging device pouch 204 of the fixation platform 200, as well as the dimensions, shapes, and relative positions of the transparent window 303 and slot 304 of the fixation dressing 300, can be configured to accommodate different vascular access devices.

[0041] Figure 5A Examples of a vascular access system 500 that can be used in implementing one or more embodiments of the present disclosure are provided. The vascular access system 500 includes one or more imaging devices 210, one or more base units 512, one or more monitoring devices 513, and a database 514. Each imaging device 210 can be used to capture images (e.g., via ultrasound, near-infrared, optical fluorescence, optical reflectance, LiDAR, or other modalities) and other vascular access data that may be associated with the vascular access device placed in a patient's blood vessel. In some embodiments, the imaging device 210 or the vascular access system 500 may include a camera for capturing photographs of the insertion site, the vascular access device 100, the fixation platform 200, external landmarks, etc. In some embodiments, the vascular access system 500 may include one or more Doppler devices that can be used to capture flow characteristics. Doppler devices may be used in place of or as a supplement to imaging devices to provide the functionality described below.

[0042] The base unit 512 (in some embodiments, it may be integrated into another component of the vascular access system 500) may represent a network-enabled computing device configured to communicate with a database 514 and possibly with one or more monitoring devices 513. For example, in some embodiments, the imaging device 210 may interface directly with the base unit 512 (e.g., via Bluetooth or another short-range communication protocol) to transmit vascular access data, and the base unit 512 may then communicate with the database 514 to store such vascular access data and / or with one or more monitoring devices 513 to display such vascular access data. In other embodiments, the imaging device 210 may have such networking capabilities and may therefore be considered to include the base unit 512.

[0043] The monitoring device 513 can be any computing device configured to display data related to continuity of care. For example, the monitoring device 513 can be a personal computer, smartphone, dedicated computing device / monitor, etc., using a web-based interface or dedicated application to display vascular access data related to the continuity of patient care. Such a monitoring device 513 can be located in the patient's room or at the nurses' station, carried by a clinician, etc. In some embodiments, the monitoring device 513 may include a base unit 512. For example, the monitoring device 513 can be placed next to the patient and the base unit 512 can functionally interface with the imaging device 210 and the database 514.

[0044] Database 514 is intended to represent any arrangement of computing components that can be used to store vascular access data for one or more patients. For example, database 514 could be a dedicated server computing device or a cloud storage device configured to perform database functionality.

[0045] Figure 5B This is a flowchart illustrating the continuity of care, which enables the capture and linking of vascular access data. Continuity of care may encompass linking the patient's vascular access history. In other words, vascular access data associated with previous vascular accesses can be retrieved to link such data in the continuity of care for subsequent vascular accesses. Continuity of care may also include collecting and / or linking vascular access data during site assessment and vascular access device placement support. These stages may require using one or more imaging devices 210 to examine the patient's vein location before and during vascular access device placement, such as to identify and select the optimal vein for placement and determine the appropriate catheter specification size and length for the target vein. During both stages of continuity of care, one or more imaging devices 210 may be used to generate and / or present vascular access data. Continuity of care may also include collecting vascular access data in the form of a baseline document of the initial placement status. This document may include the location of the vascular access device within the patient's vascular system, the extent to which the vascular access device is inserted into the patient's vascular system, etc. Continuity of care may also include collecting vascular access data throughout the course of vascular access device placement, such as records indicating assessment or monitoring of the patient and / or vascular access device, including records during procedures, events, or other events. Embodiments of this disclosure may be primarily beneficial at this stage. Continuity of care may additionally include collecting vascular access data that constitutes a record of vascular access device removal. Finally, continuity of care may include collecting vascular access data in the form of vascular access experiences and electronic health record archiving (e.g., feedback from the patient and / or one or more clinicians involved in the vascular access).

[0046] Figure 6A This is a partial cross-sectional view of the patient's vascular system 601 when the fixed platform 200 is used. As shown, the imaging device pouch 204 is positioned above the distal tip 111a of the catheter 111. Accordingly, the clinician can place the head of the imaging device 210 within the imaging device pouch 204 to capture an image of the distal tip 111a. For example, Figure 6B It is an image capturing a lateral view of the vascular system 601, catheter 111, and distal tip 111a, and Figure 6C It is an image capturing a cross-sectional view of the vascular system 601 and catheter 111. The guide 205 facilitates proper positioning of the imaging device 210 to clearly capture such a view.

[0047] Figure 7 Examples are provided of how images generated by imaging device 210, along with various information derived from those images, can be integrated into a display. As indicated, this display can be generated and / or presented on base unit 512 and / or any number of monitoring devices 513. This display may include one or more views of catheter 111 within vascular system 601, such as… Figure 6B landscape view and Figure 6C The transverse view allows clinicians to see how catheter 111 extends into vascular system 601 and thus facilitates rapid determination of whether catheter 111 is adequately inserted, whether the distal tip 111a is correctly positioned, whether there is any obstruction, or any other condition that can be detected via ultrasound or other modalities. The cross-sectional view allows clinicians to see how a specific portion of catheter 111 is positioned within vascular system 601 and thus facilitates rapid determination of whether catheter 111 may be excessively restricting blood flow through vascular system 601, or any other condition that can be detected via ultrasound. In some embodiments, the size and shape of imaging device window 204 allow a user to adjust the position of the view generated by imaging device 210. For example, a user may be able to move the cross-sectional view along the length of catheter 111 to determine whether excessive obstruction exists at any point along the length of catheter 111 by sliding imaging device 210 within imaging device window 204.

[0048] Figure 7 The illustration also shows a display that may include various vascular access data that can be generated from images produced by imaging device 210 or derived from input. For example, an indicator 701a showing the specifications of catheter 111 and an indicator 701b showing the length of catheter 111 are displayed. Indicators 701a and 701b may be obtained via user input or calculated from images generated by imaging device 210.

[0049] The display also includes indicators 702a, 702b, and 702c for different parameters. In some embodiments, these parameters may be selectable. For example, in Figure 7 In this configuration, indicator 702a provides information about the last flushing of conduit 111. This last flushing information can be calculated using images generated by imaging device 210. For example, Doppler technology can be applied to the image data to detect when fluid flows out through the distal tip 111a, and in response to this detection, base unit 612 (or monitoring device 613) can automatically store an indication that flushing occurred at that time. Figure 7 Indicators 702b and 702c have not yet been selected. However, these indicators and additional indicators can be selected to display information about any of the many different conditions, events, states, etc., as described below.

[0050] The display also includes indicators 703a and 703b that provide information about the portion of catheter 111 within vascular system 701. Indicator 703a defines the catheter-to-vein ratio (i.e., the ratio of catheter diameter to vein diameter at a given location). Indicator 703b defines the insertion length of catheter 111 (i.e., the length of catheter 111 within vascular system 701 or the percentage of catheter length within the vascular system). The display additionally includes an indicator 704 that defines the patency status of catheter 111 (i.e., whether catheter 111 can be safely retained within vascular system 701). Base unit 612 (or monitoring device 613) can use images provided by imaging device 210 to calculate the patency status (e.g., to detect the degree to which catheter 111 and / or the vascular system 701 surrounding catheter 111 may be obstructed).

[0051] As implied above, the vascular access system 500 can be configured to monitor and / or display information related to the condition of the catheter 111, the vascular system 601, or surrounding tissues, as well as various associated physiological or procedural parameters, by making full use of the images provided by the imaging device 210. This information includes catheter geometry information (e.g., catheter-to-vein ratio, catheter insertion length, flow restriction around the catheter), catheter position information (axial position of the catheter within the vein, position or angle of the distal tip of the catheter relative to the vein wall, valve, branch, or other physiological feature), catheter movement or displacement, catheter kinking, displacement events, extravasation, infiltration detection (e.g., by monitoring tissue surrounding vascular system 601), thrombosis, phlebitis (visual or associated cumulative movement), patency indicators, blood flow characteristics (e.g., by using Doppler to detect the velocity and / or volume of blood flowing into catheter 102), fluid administration flow characteristics (e.g., by using Doppler to detect the velocity, volume, direction, and / or duration of fluid flow), procedural events (e.g., flushing, blood aspiration, fluid administration), and / or the location of the aspiration liner, probe, or sensor in the vein or relative to the distal tip of the catheter or physiological feature (e.g., thrombus, valve, wall, branch, etc.).

[0052] The vascular access system 500 can provide a display of indicators including any of the information mentioned above, and can provide corresponding alarms. For example, the base unit 512 or the monitoring device 513 can be configured to output visual, auditory, tactile, or digital alarms when a condition or event is detected from an ultrasound image.

[0053] Figure 8 Examples are provided of how the base unit 512 (or possibly the monitoring device 513) can be configured to generate display content from images generated by the imaging device 210. This display content may include any of the aforementioned information, indicators, status, events, alarms, etc. (collectively, "parameters"). Figure 7 This is an example of the content being displayed.

[0054] The base unit 512 can be configured to continuously, periodically, or on demand receive images from the imaging device 210. The base unit 512 may include an image processor 512a configured to process the images to generate processed image data. This processed image data can be input to an artificial intelligence engine 512b, which can be configured to detect and / or generate parameters from the processed image data. The parameters, along with the image, can be provided to a display module 512c, which can generate display content including the image and the parameters.

[0055] In some embodiments, image processor 512a may be configured to determine various condition information from images or sequences of images, such as catheter geometry or location information, or the presence of thrombosis, kinking, or other obstructions. In some embodiments, artificial intelligence engine 512b may be trained to detect when parameters are present in the image stream. For example, artificial intelligence engine 512b may detect when a sequence of images indicates a flushing event, a blood draw event, extravasation, displacement, or movement event, etc. In some embodiments, artificial intelligence engine 512b may be used to predict the development or increased risk of potential complications or events. For example, artificial intelligence engine 512b may process images to detect that the catheter insertion length is changing or decreasing over time. If such a trend is detected or a threshold insertion length is reached (e.g., when the length of the catheter remaining in the vein is less than a certain percentage), artificial intelligence engine 512b may trigger an alarm, allowing clinicians to prevent catheter failure.

[0056] In some embodiments, the artificial intelligence engine 512b (or another artificial intelligence solution) can be used to automatically detect the depth of the distal tip 111a from images generated by the imaging device(s) 210. This detected depth can then be used to enhance the accuracy of the images. For example, to facilitate the use of mode C ultrasound, the imaging device 210 can generate images at a preset depth, and the artificial intelligence engine 512b can then evaluate the images to identify which images(s) contain the catheter 111. The known depth of the identified images(s) can then be used as depth to generate further mode C ultrasound images.

[0057] Figures 9A-9C Additional examples of a vascular access system 900 that can be used in implementing one or more embodiments of the present disclosure are provided. The vascular access system 900 may include a vascular access device 100 and a fixation dressing 200 as described above, as well as monitoring components (such as monitoring component 910). The monitoring component may include any or all of an ultrasound probe, a sensor array, or a vascular probe assembly. The monitoring component may be employed to continuously monitor the vascular access device 100. In some embodiments, such continuous monitoring may cover before, during, and after catheter insertion. In some embodiments, images, readings, and / or parameters generated by the monitoring component may be presented to a clinician, processed to automatically detect events, conditions, or other situations, stored for subsequent analysis, or otherwise used to enhance continuity of care.

[0058] exist Figure 9AIn the monitoring component 910, an ultrasound probe 911 may be included, a fixation mechanism 912 for fixing the ultrasound probe 911 to the skin and / or catheter 102, an electrical adapter 913 for connecting the cable 914 to the ultrasound probe 911, a base unit 512, a sensor array including one or more sensors 917 for sensing parameters from the surface of the patient's skin, one or more status indicators 918, and a vascular probe component 920 for sensing various parameters from within the vascular system. Figure 9A This illustrates an embodiment in which the base unit 512 has a wired connection (cable 914) to the ultrasound probe 911 and sensor 917 and a wireless connection to the vascular probe assembly 920. Figure 9B In this configuration, the monitoring component 910 includes a wireless adapter 916 to replace the cable 914, enabling the base unit 512 to have wireless connectivity with the ultrasound probe 911, sensor 917, and vascular probe assembly 920. Figure 9C In this embodiment, the monitoring component 910 includes a cable 919 connecting the vascular probe component 920 to the electrical adapter 913, and thus indicates that the vascular probe component 920 has a wired connection. Accordingly, in some embodiments, any arrangement of wireless and / or wired connections may be used.

[0059] In some embodiments, the fixation mechanism 912 may be an adhesive film on the underside of the ultrasound probe 911, which can be used to directly adhere the ultrasound probe 911 to the patient's skin above the catheter 102. In some embodiments, the fixation mechanism 912 may be a mechanical connection between the ultrasound probe 911 and the catheter adapter 101 and / or the catheter 102. In some embodiments, the electrical adapter 913 may be detachable from the ultrasound probe 911, while in other embodiments, the electrical adapter 913 may be integrated with the ultrasound probe 911. In some embodiments, the electrical adapter 913 may include one or more connectors through which sensors 917 may be selectively connected to form a sensor array. In some embodiments, one or more sensors 917 may be integrated into the electrical adapter 913. In some embodiments, one or more sensors 917 may be integrated into the fixation dressing 200.

[0060] The base unit 512 may be any device including a circuitry for communicating with the ultrasound probe 911, each sensor 917 in the sensor array, and the vascular probe assembly 920. In some embodiments, the base unit 512 may provide power to the ultrasound probe 911, each sensor 917, and / or the vascular probe assembly 920. In some embodiments, the base unit 512 may directly process images received from the ultrasound probe 911 and readings received from (one or more) sensors 917 and / or the vascular probe assembly 920, while in other embodiments, the base unit 512 may receive images from the ultrasound probe 911 and readings from (one or more) sensors 917 and / or the vascular probe assembly 920 and forward the images and / or readings to another device for processing. In some embodiments, the base unit 512 may include user input elements to allow a user (e.g., a clinician and / or patient) to control the ultrasound probe 911, (one or more) sensors 917, and / or the vascular probe assembly 920. In some embodiments, the base unit 512 may be connected to one or more other devices to allow users of the one or more other devices to control the ultrasound probe 911, one or more sensors 917 and / or vascular probe assembly 920.

[0061] In some embodiments, the ultrasound probe 911 may be integrated into the fixation dressing 200. In other embodiments, the ultrasound probe 911 may be separate from the fixation dressing 200. In such embodiments, the ultrasound probe 911 may be positioned above the catheter 102, and the fixation dressing 200 may be positioned above the ultrasound probe 911, one or more sensors 917, and the catheter adapter 101. In any case, the ultrasound probe 911 may be positioned on the patient's skin such that when the catheter 102 is inserted into the patient's vascular system, the ultrasound probe is positioned above the distal tip of the catheter 102. One or more sensors 917 may also be positioned above or near the distal tip of the catheter 102.

[0062] In some embodiments, the vascular probe assembly 920 may be integrated into the vascular access device 100. In some embodiments, the vascular probe assembly 920 may be configured to be coupled to the vascular access device 100 via a proximal patient access port 105. The vascular probe assembly 920 may include a probe 923 and one or more sensors 923a positioned at the distal end of the probe 923. The vascular probe assembly 920 may also include an electrical adapter 921 through which the sensors 923a may be electrically coupled to a monitoring assembly 910.

[0063] Vascular access probes can be configured in various ways. Figure 11A and Figure 11BExamples of how the vascular probe assembly 920 can be configured in some embodiments are provided. As shown, the vascular probe assembly 920 may include an electrical adapter 921 at the proximal end and a probe 923 extending distally from the electrical adapter 921. One or more sensors 923a may be positioned distally at the probe 923 such that they will be positioned within the patient's vascular system during use. The sensors 923a may be electrically connected to the electrical adapter 921 (e.g., via one or more wires, traces, or other electrical connection media). The vascular probe assembly 920 may include a housing 924 and a coupler 922 distally at the housing 924. The coupler 922 may be configured to couple to a proximal patient access port 105. A slider 925 may be secured to the housing 924 and configured to move the probe 923 from an initial proximal position (e.g., as shown in the figure). Figure 11A (As shown) Slide to the far-side deployment location (e.g., as shown) Figure 11B (as shown in the diagram). In some embodiments, housing 924 may be configured to separate from coupler 922 to expose electrical adapter 921. In some embodiments, housing 924 may be configured to separate only after slider 925 has been slid distally to deploy probe 923.

[0064] Figure 12A and Figure 12B Another example of how the vascular probe assembly 920 can be configured is provided in some embodiments. In these embodiments, the vascular probe assembly 920 also includes an extension 926 between the probe 923 and the electrical adapter 921. One or more wires, traces, or other electrical connection media may extend through the extension 926 to allow power supply and / or control of one or more sensors 923a via the electrical adapter 921. Figure 12B As shown, the extension 926 allows the electrical adapter 921 to be positioned away from the patient access port 105.

[0065] In embodiments where the monitoring component 910 includes the vascular probe component 920, the monitoring component 910 may further include a hub 915 that can be connected to an electrical adapter 921. The hub 915 may be configured to power(s) one or more sensors 923a and / or enable communication with(s) one or more sensors 923a. For example, the hub 915 may include a wireless interface that enables communication between(s) one or more sensors 923a and the base unit 512 (or possibly(s) one or more monitoring devices 513). In some embodiments, the hub 915 may include one or more batteries for powering the sensors 923a. In some embodiments, the hub 915 may form a wired interface through which(s) one or more sensors 923a are connected to the electrical adapter 913 (or possibly directly to a cable 914). In some embodiments, communication and / or power may be delivered via a cable 919. Figure 12B In this embodiment, hub 915 provides a connection point for cable 914 and indicates that the monitoring component 910 includes only an embodiment of the vascular probe component 920.

[0066] Figures 10A-10C Additional examples of how the vascular access system 900 can be configured in some embodiments are provided. Figure 10A In the monitoring component 910, a hub 915 is directly coupled to an electrical adapter 921 of the vascular probe component 920, and a cable 919 is connected to the electrical adapter 913. Furthermore, in Figure 10A In the fixation dressing 200, the window 203 extends beyond the insertion site and covers the ultrasound patch 911.

[0067] In some embodiments, such as Figure 10A The hub 915 shown herein can be configured to interface with the base unit 512, while in other embodiments, the hub 915 can serve as the base unit 512. The hub 915 can provide power to and / or communicate with the ultrasonic probe 911 via the cable 919.

[0068] like Figure 10AThe hub 915, as illustrated, also includes an integrated display through which one or more parameters (e.g., heart rate, body temperature, blood oxygen level) can be displayed. In some embodiments, such parameters can be derived from readings obtained by sensor 923a. In embodiments where the monitoring component 910 includes a sensor array, such parameters can be derived from readings obtained by sensor 917. In some embodiments, this display can also, or alternatively, be configured to display images and / or parameters generated by ultrasound probe 911. Accordingly, this display can be used to present any information or content generated by monitoring component 910 at the point of care. Hub 915 can also communicate with monitoring device 513 directly or via base unit 512.

[0069] exist Figure 10B In China, the vascular access system is similar to 900. Figure 10A As shown in the diagram. However, hub 915 does not include a display and forms a wired interface with electrical adapter 913 via cable 919. Electrical adapter 913 also forms a wired interface with base unit 512 via cable 914. Figure 10C In China, the vascular access system is similar to 900. Figure 10B As shown in the diagram. However, cable 914 connects between hub 915 and base unit 512. Figures 10A-10C In this diagram, monitoring component 910 does not include a sensor array. However, a sensor array may be included in any embodiment represented by these figures.

[0070] One or more monitoring devices 513 may represent any device having a display on which images generated by the ultrasound probe 911 can be displayed, and / or information obtained from such images and / or readings from one or more sensors 917 and / or one or more sensors 923a. As examples, one or more monitoring devices 513 may include smartphones, tablets, laptops, desktop computers, thin clients, televisions, dedicated display devices, infusion pumps, patient vital signs monitors, arterial monitors, ultrasound system visual displays, etc. In some embodiments, monitoring device 513 may be used as a base unit 512. Monitoring device 513 may also be configured to interface with one or more independent computing systems, such as systems for storing patient data.

[0071] In embodiments including a wireless adapter 916, the wireless adapter 916 may be configured to transmit images generated by the ultrasound probe 911 and / or readings from one or more sensors 917 and / or one or more sensors 923a to the base unit 512 or possibly to one or more monitoring devices 513. The wireless adapter 916 may also include a battery for powering the ultrasound probe 911, one or more sensors 917, and / or the vascular probe assembly 920. In some embodiments, the wireless adapter 916 may be integrated into the electrical adapter 913, while in other embodiments, the wireless adapter 916 may be selectively coupled to the electrical adapter 913.

[0072] Figure 9A-10C Examples of vascular access systems 900 including peripheral venous catheters are provided. However, vascular access systems can be used with central venous catheters, peripherally inserted central venous catheters, midline catheters, arterial catheters, ports, venous punctures, subcutaneous access devices or other indwelling catheters, probes, sensors or instruments.

[0073] According to one or more embodiments of this disclosure, any of the above-described vascular access systems, or any other suitable vascular access system, can be used for site assessment and / or archiving of vascular access devices. For example, such vascular access systems can be used intermittently or continuously to assist in the placement of vascular access devices and to assess the current status of indwelling vascular access devices. In some embodiments, vascular access systems can be configured to fully utilize prior status, established clinical criteria, and / or relevant clinical data to predictively detect, identify, and / or diagnose the risk of catheter-related complications, and / or to detect, identify, and / or diagnose complications that have occurred. In short, embodiments of this disclosure enable vascular access systems to be fully utilized for objective assessment of vascular access devices based on clinical indications.

[0074] As referenced above Figure 8 As described, in some embodiments, the vascular access system can be configured to use artificial intelligence models to identify procedural events, device or site manipulation, acute malfunction events, or other site changes that may affect the continued feasibility of vascular access devices and placement (collectively, "indwelling events or conditions"). The vascular access system can also be used to automatically archive or chart vascular access data related to indwelling events or conditions.

[0075] In some embodiments, the AI ​​diagnostic and predictive model may be constructed, guided, and refined based on associations between current device, site, and patient assessments and clinically observed catheter complications and malfunctions, as well as with previous device, site, and patient assessments and histories, patient history, disease status, applicable clinical criteria (e.g., INS criteria), hospital policies and standards, limits and thresholds expected by clinicians, payer or insurance company standards with applicable safety factors, etc. Thresholds and alarm limits may be stratified and set according to listed or otherwise defined criteria and limits.

[0076] Figures 13A-13C Examples are provided of how vascular access device indwelling assessment and archiving can be implemented according to one or more embodiments. In the depicted embodiments, an artificial intelligence (AI) system 1300 is employed and includes a data processor 1301, an AI database 1302, a model trainer 1303, and an AI engine 512b. The AI ​​system 1300 can typically be independent of many different vascular access systems but interface with them. However, in some embodiments, the AI ​​system 1300 may be at least partially integrated into the vascular access system.

[0077] Figure 13A This illustrates how AI system 1300 can generate labeled datasets from vascular access data for training one or more AI models that can be used to perform vascular access placement assessments. As shown, one or more vascular access systems can generate processed image data, sensor readings, and / or other vascular access data to data processor 1301. This vascular access data can be generated in any of the ways described above. For example, vascular access systems (e.g., base unit 512) can be configured to report all the vascular access data they generate to data processor 1301. In this way, data processor 1301 can collect large vascular access datasets that may contain vascular access data indicating many different placement events or conditions.

[0078] In some embodiments, as part of reporting such vascular access data, one or more vascular access systems (e.g., AI Engine 512b) may also be configured to report any events, detections, alerts, etc., that it may have generated for a specific set of vascular access data (e.g., in conjunction with...). Figure 8 (Similar to the manner illustrated in the document). Moreover, in some embodiments, one or more vascular access systems can be configured to receive user input to acknowledge any events, detections, alarms, etc., that may be associated with vascular access data, and in such cases, this acknowledgment input can also be provided to the data processor 1301.

[0079] Data processor 1301 can process the received vascular access data to generate a labeled dataset. For example, data processor 1301 can associate tags representing indwelling events or conditions with vascular access data (or features in the vascular access data) indicating such indwelling events or conditions. For example, the labeled dataset can associate tags representing thrombosis with numerous instances of image data indicating thrombosis. This labeled dataset can be stored in AI database 1302. In some embodiments, Figure 13A The process described in the diagram can be performed continuously because the vascular access system is used to update and refine the labeled dataset.

[0080] In some embodiments, labeled datasets can be generated using vascular access data associated with a specific patient category (e.g., child or elderly), data associated with a specific location or entity (e.g., a specific hospital or a hospital of a specific provider), or data associated with any other category or grouping. This can allow AI models to be trained for these specific categories.

[0081] Figure 13B This indicates how the model trainer 1303 can use the labeled dataset to generate and train an AI model, which can then be provided to the AI ​​engine 512b. For example, the model trainer 1303 can create and train an AI model that can be fully utilized to automatically and in real-time detect indwelling events or conditions from vascular access data.

[0082] Figure 13C This illustrates how the AI ​​engine 512b can use AI models to perform vascular access device placement assessment and archiving. As shown in the figure, the vascular access system can provide processed image data, sensor readings, and / or other vascular access data (whether intermittent or continuous, as described above) to the AI ​​engine 512b. The AI ​​engine 512b can evaluate this vascular access data against an AI model to assess the vascular access device. For example, the AI ​​engine 512b can analyze processed image data against an AI model to determine whether the processed image data exhibits any characteristics indicative of a placement event or condition.

[0083] In some embodiments, AI engine 512b may detect indwelling events or conditions or make corresponding recommendations based solely on the evaluation of vascular access data by a control AI model. In other embodiments, AI engine 512b may evaluate other criteria to make such detections or recommendations. In some embodiments, these criteria may include applicable clinical standards, hospital policies and standards, limits and thresholds expected by clinicians, payer or insurance company standards with applicable safety factors, patient history or disease status, etc. For example, based on the evaluation of vascular access data by a control AI model, AI engine 512b may detect that a vascular access device has not been flushed for some time and may subsequently use hospital-specific criteria to determine whether to generate a recommendation to flush the vascular access device. As another example, based on the evaluation of vascular access data by a control AI model, AI engine 512b may detect that a vascular access device is partially blocked and may subsequently use applicable criteria to determine whether to generate an alert that the vascular access device should be replaced. In some embodiments, criteria may specify thresholds and limits for determining when or what type of notification should be generated.

[0084] Based on its AI model's evaluation of vascular access data and when it detects indwelling events or conditions, the AI ​​engine 512b can output appropriate AI-generated notifications, which can then be displayed on the monitoring device 513 or otherwise output within the vascular access system. In this way, the AI ​​engine 512b can automatically assess vascular access devices and provide appropriate notifications to facilitate and improve patient care.

[0085] Figure 13C It also states that the AI ​​engine 512b can automatically archive any indwelling events or conditions in the patient's records. In this way, indwelling events and conditions can be automatically associated with the patient's pre- and / or post-insertion assessments, the patient's historical vascular access, etc. In some embodiments, such archiving may include marking portions of vascular access data identified as indicating indwelling events or conditions, allowing the AI ​​model to be customized for that specific patient in future use cases.

[0086] All examples and conditional language set forth herein are intended for educational purposes to help the reader understand the invention and the concepts contributed by the inventors to advance the art, and should not be construed as being limited to these specifically set examples and conditions. While embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications may be made herein without departing from the spirit and scope of the invention.

Claims

1. A method for performing vascular access device assessment, comprising: The system receives vascular access data related to a vascular access device with a catheter inserted into the patient's vascular system at the artificial intelligence (AI) engine of the vascular access system. The AI ​​engine evaluates vascular access data against an AI model to detect one or more indwelling events or conditions; and One or more notifications are generated by the AI ​​engine, indicating one or more detention events or conditions.

2. The method of claim 1, wherein the vascular access data includes catheter imaging data.

3. The method of claim 2, wherein the vascular access data includes sensor readings.

4. The method of claim 2, wherein evaluating vascular access data against an AI model to detect the one or more indwelling events or conditions includes determining that the imaging data includes one or more features indicative of the one or more indwelling events or conditions.

5. The method of claim 4, wherein determining the imaging data includes determining that one or more features indicative of the one or more indwelling events or conditions include determining that the imaging data matches labeled vascular access data on which an AI model has been trained.

6. The method of claim 1, further comprising: The one or more notifications are displayed in the vascular access system.

7. The method of claim 1, further comprising: Update the patient's records to include the one or more detention events or conditions.

8. The method of claim 1, further comprising: The labeled dataset from which the AI ​​model was trained was updated using vascular pathway data.

9. The method of claim 1, wherein evaluating vascular access data against an AI model to detect one or more indwelling events or conditions includes taking into account additional criteria.

10. The method of claim 9, wherein the additional criteria include one or more of the following: One or more policies; One or more standards; One or more security factors; The patient's medical history; or The patient's disease or the state of the disease.

11. The method of claim 9, wherein considering additional criteria includes evaluating one or more thresholds or limits to determine whether to generate the one or more notifications.

12. The method of claim 1, wherein vascular access data is received intermittently or continuously over a period of time.

13. The method of claim 1, further comprising: Receive data from other vascular access systems at the data processor; A labeled dataset is generated from the other vascular pathway data by a data processor; and The AI ​​model is trained by the model trainer using a labeled dataset.

14. The method of claim 13, wherein the other vascular access data includes imaging data of catheters inserted into the vascular systems of other patients.

15. One or more computer storage media storing computer-executable instructions, which, when executed, implement a method for performing vascular access device assessment, the method comprising: Maintaining the AI ​​model; Receive vascular access data relating to a vascular access device having a catheter inserted into a patient's vascular system, the vascular access data including catheter imaging data; and Using AI models to evaluate catheters.

16. The computer storage medium of claim 15, wherein evaluating the catheter using an AI model includes determining vascular access data from the AI ​​model indicating one or more indwelling events or conditions.

17. The computer storage medium of claim 16, wherein the method further comprises: Generate one or more notifications for the one or more detention events or conditions; as well as The patient's record shall file one or more of the aforementioned indwelling events or conditions.

18. A vascular access system, comprising: A vascular access device, the vascular access device including a catheter; A monitoring component, the monitoring component including an imaging device configured to be positioned above the catheter when the catheter is inserted into the patient's vascular system; A base unit configured to receive vascular access data, including imaging data, from a monitoring component; as well as An AI engine is configured to evaluate vascular access data against an AI model to detect one or more indwelling events or conditions from imaging data.

19. The vascular access system of claim 18, wherein the imaging device is an ultrasound probe.

20. The vascular access system of claim 18, further comprising: One or more monitoring devices, the one or more monitoring devices being used to present one or more notifications related to the one or more detention events or conditions.

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