Vascular access device indwell assessment and documentation

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 a vascular access device including to detect indwell events and status. The AI engine can generate notifications of any indwell events or status it detects during the assessment. The AI engine may also document any indwell events or status.

Description

VASCULAR ACCESS DEVICE INDWELL ASSESSMENT AND DOCUMENTATIONBACKGROUND

[0001] Vascular access devices are commonly used for a variety of infusion therapies. For example, vascular access devices may be used for infusing therapeutic agents or fluids into a patient. Vascular access devices may also be used for withdrawing blood from the patient. There are a variety of vascular access devices commonly used in a medical setting, including, for example, peripherally-inserted central catheters, midline catheters, central venous catheters, dialysis catheters, and arterial catheters.

[0002] A common type of vascular access device includes a catheter that is over-the-needle. As its name implies, the catheter that is over-the-needle may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient. To verify proper placement of the introducer needle and / or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the catheter may be left in place for future blood withdrawal or fluid infusion.

[0003] Figure 1A provides an example of a prior art vascular access device 100 that may be used when embodiments of the present disclosure are implemented. Vascular access device 100 includes a catheter adapter 110 from which a catheter 111 extends. Catheter adapter 111 may also include a side port 112 by which an extension set 114 is connected to catheter adapter 111.Vascular access device 100 may also include a stabilization platform 1 13 for stabilizing catheter adapter 111 when positioned on a patient. Vascular access device 100 is only one example of the many vascular access devices that could be used when embodiments of the present disclosure are implemented. For example, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), midline catheters, arterial catheters, peripheral intravenous catheters (PIVCs), long PIVCs, venipuncture devices, sub-cutaneious access devices, and other indwelling tube, probe, sensor, or instrument devices could be used.

[0004] Although catheter indwell performance (i.e., how long the catheter can be safely left in the vasculature) has improved in recent years, there remains a significant number of complications that may develop throughout the intended dwell time of a vascular access device. These complications may include dislodgement, infiltration, extravasation, phlebitis, catheter-related infection, and loss of patency, among others.

[0005] Different types of ultrasound instruments exist for use in monitoring a catheter. For example, Figure IB illustrates a prior art piezoelectric transducer array for performing ultrasound 10 (or ultrasound probe 10). Ultrasound probe 10 is conformable and can therefore be worn on the skin and used to perform deep tissue imaging.

[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.SUMMARY

[0007] The present disclosure relates generally to performing vascular access device assessment and documentation. An artificial intelligence system can be used to gather vascular access data for training an Al model. An Al engine can use the Al model to automatically assess a vascular access device including to detect indwell events and status. The Al engine can generate notifications of any indwell events or status it detects during the assessment. The Al engine may also document any indwell events or status.

[0008] In some embodiments, a vascular access device assessment may by performed by an Al of a vascular access system. The Al engine may receive vascular access data pertaining to a vascular access device having a catheter that is inserted into a patient’s vasculature. The Al engine may evaluate the vascular access data against an Al model to detect one or more indwell events or status. The Al engine may generate one or more notifications indicative of the one or more indwell events or status.

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

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

[0011] In some embodiments, evaluating the vascular access data against the Al model to detect the one or more indwell events or status may include determining that the imaging data includes one or more characteristics indicative of the one or more indwell events or status.

[0012] In some embodiments, determining that the imaging data includes one or more characteristics indicative of the one or more indwell events or status may include determining that the imaging data matches labeled vascular access data on which the Al model was trained.

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

[0014] In some embodiments, a record of the patient may be updated to include the one or more indwell events or status.

[0015] In some embodiments, the vascular access data may be used to update a labeled dataset from which the Al model was trained.

[0016] In some embodiments, additional criteria may be considering when evaluating the vascular access data against an Al model to detect one or more indwell events or status.

[0017] In some embodiments, the additional criteria includes one or more of: one or more policies; one or more standards; one or more safety factors; history of the patient; or a disease or state of the disease of the patient.

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

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

[0020] In some embodiments a data processor may receive other vascular access data from other vascular access systems and generate labeled dataset from the other vascular access data. A model trainer may then train the Al model using the labeled dataset.

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

[0022] In some embodiments, computer storage media may store computer executable instructions which when executed implement a method for performing vascular access device assessment. An Al model may be maintained. Vascular access data can be received. The vascularaccess data can pertain to a vascular access device having a catheter that is inserted into a patient’s vasculature. The vascular access data may include imaging data of the catheter. The Al model may be used to assess the catheter.

[0023] In some embodiments, using the Al model to assess the catheter may include determining, from the Al model, that the vascular access data is indicative of one or more indwell events or status.

[0024] In some embodiments, one or more notifications may be generated for the one or more indwell events or status and the one or more indwell events or status can be documented in a record of the patient.

[0025] In some embodiments, a vascular access system can include a vascular access device comprising a catheter, a monitoring assembly comprising an imaging device that is configured to be positioned overtop the catheter when the catheter is inserted into a patient’s vasculature, a base unit that is configured to receive vascular access data comprising imaging data from the monitoring assembly, and an Al engine that is configured to evaluate the vascular access data against an Al model to detect one or more indwell events or status from 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 pertaining to the one or more indwell events or status.

[0028] It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodimentsmay be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0029] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0030] Figure 1 A illustrates a prior art vascular access device that could be used in one or more embodiments of the present disclosure;

[0031] Figure IB illustrates a prior art piezoelectric transducer array for performing ultrasound;

[0032] Figure 2A illustrates a securement platform that may be used when one or more embodiments of the present disclosure are implemented;

[0033] Figure 2B illustrates a vascular access system that may be used when one or more embodiments of the present disclosure are implemented;

[0034] Figure 3A illustrates another securement platform that may be used when one or more embodiments of the present disclosure are implemented;

[0035] Figure 3B illustrates another securement platform that may be used when one or more embodiments of the present disclosure are implemented;

[0036] Figure 4A illustrates another securement platform that may be used when one or more embodiments of the present disclosure are implemented;

[0037] Figure 4B illustrates the securement platform of Figure 4A when used with a vascular access device;

[0038] Figure 4C illustrates the securement platform of Figure 4A when a securement dressing is used to secure the vascular access device;

[0039] Figure 5A is a block diagram of components of vascular access system that may be used when one or more embodiments of the present disclosure are implemented;

[0040] Figure 5B is a flow diagram representing the continuity of care;

[0041] Figure 6A is a cross-sectional view of the vasculature that may be generated using a vascular access system;

[0042] Figures 6B and 6C are example images generated by the vascular access system of Figure 6 A;

[0043] Figure 7 is an example display that can be generated by a vascular access system;

[0044] Figure 8 provides an example of electronic components of a base unit or monitoring device of a vascular access system;

[0045] Figures 9A-10C provide additional examples vascular access systems that may be used when one or more embodiments of the present disclosure are implemented;

[0046] Figures 11 A and 1 IB provide an example of a vascular probe assembly that may form part of a vascular access system;

[0047] Figures 12A and 12B provide another example of a vascular probe assembly that may form part of a vascular access system; and

[0048] Figures 13A-13C provide an example of how vascular access device assessment and documentation can be performed in accordance with one or more embodiments.DESCRIPTION OF EMBODIMENTS

[0049] In this specification and the claims, the term “continuity of care” is intended to represent the entire duration of a vascular access including pre-insertion, during insertion, indwell duration, and post-removal. A “vascular access device” should be construed as encompassing an intravenous catheter device and any other device by which a patient’ s vasculature may be accessed. “Vascular access data” should be construed as encompassing any data relating to the access of a patient’s vasculature using a vascular access device and includes images of the patient’s vasculature, characteristics of the vascular access device, information about the placement and / or removal of the vascular access device, information about events that occur during the indwell of the vascular access device, complications detected, the patient’s vitals, fluid and blood flow characteristics, etc.

[0050] Prior to describing how vascular access device indwell assessment and documentation may be performed in accordance with embodiments of the present disclosure, various vascular access systems will be described. These and any other suitable vascular access systems could be used to facilitate vascular access device indwell assessment and documentation in accordance with embodiments of the present disclosure.

[0051] Figure 2A provides an example of a securement platform 200 that is configured for use with vascular access device 100 and can be positioned under vascular access device 100 during use as is shown in Figure 2B. Securement platform 200 includes a base layer 201 which may have an adhesive underside to allow securement platform 200 to be adhered to the patient’s skin. Base layer 201 may also include a vascular access device pocket 202 that may be shaped and sized to generally match stabilization platform 113. In some embodiments, vascular access device pocket 202 may be a cutout that exposes the patient’s skin thereby allowing stabilization platform 113 tobe placed directly on the skin. In other embodiments, vascular access device pocket 202 may be a portion of base layer 201 having an adhesive on its upper surface so that stabilization platform 113 can be adhered to base layer 201.

[0052] Securement platform 200 can also include a catheter insertion site window 203 that is positioned distal to vascular access device pocket 202 to allow catheter 111 to pass through securement platform 200 and into the patient’s vasculature when catheter adapter 110 is positioned above securement platform 200. In some embodiments, catheter insertion site window 203 may be shaped and sized to accommodate antimicrobial patches or pads or to enable the application and containment of skin adhesive for sealing the insertion site. In some embodiments, a slot (not shown) may be formed in base layer 201 and may extend between catheter insertion site window203 and the periphery of base layer 201 to enable securement platform 200 to be placed under vascular access device 100 after insertion of catheter 111.

[0053] Securement platform 200 also includes an imaging device pocket 204 that is positioned distal to catheter insertion site window 203. Imaging device pocket 204 can be spaced from catheter insertion site window 203 at a distance that corresponds to the length of catheter 111. In other words, imaging device pocket 204 can be positioned so that it will be overtop the distal tip of catheter 111 when catheter 111 is inserted into the vasculature and stabilization platform 113 is positioned in vascular access device pocket 202. In some embodiments, imaging device pocket204 may be a cutout that exposes the patient’s skin. In other embodiments, imaging device pocket 204 may be formed of a gel cap to facilitate imaging. The size and shape of imaging device pocket 204 can be selected to accommodate a range of imaging device head shapes and orientations including rectangular, square, or other shape running in the transverse and / or longitudinalorientation. Figure 2B shows two examples of imaging devices 210 that could be used when intermittent monitoring is desired.

[0054] In some embodiments, imaging device pocket 204 may be at least partially surrounded by a guide 205. In some embodiments, guide 205 may be raised from base layer 201 to form a wall around imaging device pocket 204. Guide 205 may facilitate controlled adjustments to an imaging device 210 when positioned in imaging device pocket 204 such as to control probe angle or rotation across multiple degrees of freedom (e.g., of an ultrasound probe).

[0055] In some embodiments where imaging device pocket 204 includes a gel cap, the gel cap may be a single-use stand-alone device that is integrated into the securement platform 200. In other embodiments, the gel cap could be attached to the patient or imaging device 210 to be readily accessible for use within imaging device pocket 204. In some embodiments, the gel cap could have antimicrobial properties to allow imaging device pocket 204 to remain clean through multiple uses of an imaging device 210. In some embodiments, a gel cap could be configured to be capable of being rehydrated so that the gel cap may be used multiple times within imaging device pocket 204.

[0056] Figure 3 provides an example where securement platform 200 is formed of two separate components 200a and 200b. Component 200a includes vascular access device pocket 202 and catheter insertion site window 203, while component 200b includes imaging device pocket 204. This two-component configuration of securement platform 200 can be used to accommodate catheters 1 11 of different lengths such as for long peripheral intravenous catheters and midline catheters. In some embodiments, component 200b can have an expanded base layer 201 to facilitate adhering component 200b to the patient’s skin.

[0057] Figure 3A also provides an example where securement platform 200 includes a securement dressing 300 that is placed overtop securement platform 200 (which in this case is overtop component 200a) to secure vascular access device 100 in place relative to securement platform 200. Securement dressing 300 can include a layer 301 that may be shaped and sized to match the proximal end of securement platform 200 (e.g., to match the size and shape of component 200a). Layer 301 may include a transparent window 303 that aligns / overlaps with catheter insertion site window 203 to facilitate viewing the insertion site. In some embodiments, transparent window 303 may align / overlap with at least a portion of vascular access device pocket 202 to facilitate viewing catheter adapter 110. Layer 301 may also include a border 302. In some embodiments, the underside of border 302 may include an adhesive for securing securement dressing 300 to securement platform 200. In some embodiments, a slot 304 may be formed in border 302 to allow extension set 114 to pass through securement dressing 300. Figure 3B is the same as Figure 3A but shows that component 200b can be oriented in a longitudinal orientation relative to catheter 111.

[0058] In some embodiments, securement platform 200 may consist only of component 200b. In such embodiments, securement platform 200 may be positioned appropriately to ensure that imaging device pocket 204 is overtop the distal tip of catheter 111.

[0059] Figures 4A-4C provide another example of a securement platform 200 that is configured for use with a differently configured vascular access device 100, which is a non-integrated vascular access device. These figures represent how the size, shape, and relative positions of vascular access device pocket 202, catheter insertion site window 203 and imaging device pocket 204 of securement platform 200 and of transparent window 303 and slot 304 of securement dressing 300 can be configured to accommodate different vascular access devices.

[0060] Figure 5A provides an example of a vascular access system 500 that may be used when one or more embodiments of the present disclosure are implemented. 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 florescence, optical reflectivity, LiDAR, or other modality) and possibly other vascular access data in connection with a vascular access device being placed in the vascular of a patient. In some embodiments, imaging device 210 or vascular access system 500 could include a camera for capturing photographs of the insertion site, vascular access device 100, securement platform 200, external landmarks, etc. In some embodiments, vascular access system 500 could include one or more doppler devices that may be used to capture flow characteristics. A doppler device could be used in place of or in addition to an imaging device to provide functionality as described below.

[0061] A base unit 512, which may be integrated into another component of vascular access system 500 in some embodiments, can represent a networking-capable computing device that is configured to communicate with database 514 and possibly with monitoring device(s) 513. For example, in some embodiments, imaging device 210 may interface directly with base unit 512 (e g., via Bluetooth or another short-range communication protocol) for communicating vascular access data which in turn may communicate with database 514 for storing such vascular access data and / or with monitoring device(s) 513 for displaying such vascular access data. In other embodiments, imaging device 210 may have such networking capabilities and may therefore be viewed as including base unit 512.

[0062] A monitoring device 513 can be any computing device that is configured to display data related to the continuity of care. For example, a monitoring device 513 could be a personalcomputer, smart phone, dedicated computing device / di splay, etc. on which a web-based interface or dedicated application is used to display vascular access data pertaining to the continuity of care for a patient. Such monitoring devices 513 could be positioned in the patient’ s room or at a nursing station, carried by a clinician, etc. In some embodiments, a monitoring device 513 may include a base unit 512. For example, a monitoring device 513 could be placed next to a patient and could implement the functionality of a base unit 512 to interface with an imaging device 210 and database 514.

[0063] Database 514 is intended to represent any arrangement of computing components that may be used to store vascular access data for one or more patients. For example, database 514 could be a dedicated server computing device or cloud storage that is configured to implement database functionality.

[0064] Figure 5B is a flow diagram representing the continuity of care throughout which embodiments enable the capture and connecting of vascular access data. The continuity of care can encompass connecting a patient’s vascular access history. In other words, vascular access data pertaining to previous vascular accesses can be retrieved to connect such data throughout the continuity of care of a subsequent vascular access. The continuity of care can also include collecting and / or connecting vascular access data during a site assessment and vascular access device placement support. These stages may entail using one or more imaging devices 210 to examine the location of the patient’s veins both prior to and during the placement of a vascular access device such as to identify and select the best vein for placement and to determine the appropriate catheter gauge size and length for the target vein. The one or more imaging devices 210 can be used to generate and / or present vascular access data during these two stages of the continuity of care. The continuity of care can further include collecting vascular access data in theform of placement initial state baseline documentation. This documentation may include a position of the vascular access device within the patient’s vasculature, the extent to which the vascular access device is inserted into the patient’s vasculature, etc. The continuity of care may also include collecting vascular access data throughout the indwell of the vascular access device such as documentation representing an assessment or monitoring of the patient and / or the vascular access device including during procedures, events, or other occurrences. Embodiments of the present disclosure may primarily be beneficial for this stage. The continuity of care may additionally include collecting vascular access data constituting documentation of the removal of the vascular access device. Finally, the continuity of care may include collecting vascular access data in the form of vascular access experience and electronic health record documentation (e.g., feedback from the patient and / or one or more clinician’s that were involved in the vascular access).

[0065] Figure 6A is a partial cross-sectional view of a patient’s vasculature 601 when securement platform 200 is used. As shown, imaging device pocket 204 is positioned overtop the distal tip 11 la of catheter 111. Accordingly, a clinician can place the head of an imaging device 210 within imaging device pocket 204 to capture images of distal tip I l la. For example, Figure 6B is an image that captures a transverse view of vasculature 601, catheter 111, and distal tip I l la, and Figure 6C is an image that captures a cross-sectional view of vasculature 601 and catheter 111. Guide 205 can facilitate positioning imaging device 210 appropriately to capture such views clearly.

[0066] Figure 7 provides an example of how images generated by imaging device 210 can be integrated into a display along with various information derived from the images. As indicated, this display could 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 vasculature 601such as the transverse view of Figure 6B and the cross-sectional view of Figure 6C. The transverse view may allow a clinician to see how catheter 111 is extending into vasculature 601 and may therefore facilitate quickly determining if catheter I l l is inserted sufficiently, if distal tip 11 la is positioned correctly, if there is any blockage, or any other condition that is capable of being detected via ultrasound or other modality. The cross-sectional view may allow a clinician to see how a particular portion of catheter 111 is positioned within vasculature 601 and may therefore facilitate quickly determining if catheter 111 may be excessively limiting blood flow through vasculature 601 or any other condition that is capable of being detected via ultrasound. In some embodiments, the size and shape of imaging device window 204 can enable a user to adjust the location of the views 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 if there is excessive blockage at any portion along the length of catheter 111 by sliding imaging device 210 within imaging device window 204.

[0067] Figure 7 also illustrates that the display may include a variety of vascular access data that may be derived from the images that imaging device 210 produces or from input. For example, the display includes an indicator 701a of the gauge of catheter 111 and an indicator 701b of the length of catheter 111. Indicators 701a and 701b could be obtained via user input or could be calculated from the images produced by imaging device 210.

[0068] The display also includes indicators 702a, 702b, and 702c for different parameters. In some embodiments, these parameters could be selectable. For example, in Figure 7, indicator 702a provides information for when catheter 111 was last flushed. This last flush information could be calculated using the images produced by imaging device 210. For example, doppler techniques could be applied to the image data to detect when fluid is flowing out through distal tip 11 la, andin response to such a detection, base unit 612 (or a monitoring device 613) could automatically store an indication that a flush has occurred at that time. In Figure 7, indicators 702b and 702c have not been selected. However, these indicators and additional indicators could be selected to display information for any of many different conditions, events, statuses, etc. as described below.

[0069] The display further includes indicators 703a and 703b that provide information about the portion of catheter 111 that is inside vasculature 701. Indicator 703a defines the catheter to vein ratio (i.e., the ratio of the catheter’s diameter to the vein’s diameter at a particular location). Indicator 703b defines the purchase of catheter 111 (i.e., the length of catheter 111 that is inside vasculature 701 or the percentage of the catheter length that is inside the vasculature). The display additionally includes an indicator 704 defining a patency status of catheter 111 (i.e., whether catheter 111 can safely remain within vasculature 701). Base unit 612 (or a monitoring device 613) could calculate the patency status using the images provided by imaging device 210 (e.g., to detect the extent to which catheter 111 and / or vasculature 701 around catheter 111 may be blocked).

[0070] As suggested above, vascular access system 500 can be configured to monitor and / or display information relating to the status of catheter 111, vasculature 601, or the surrounding tissue and a variety of associated physiological or procedural parameters by leveraging images that are provided by imaging device 210. This information includes catheter geometry information (e.g., the catheter to vein ratio, the purchase of the catheter, flow restrictions around the catheter), catheter position information (axial position of the catheter within the vein, the position or angle of the distal tip of the catheter relative a vein wall, valve, branch or other physiological feature), catheter movement or displacement, catheter kinking, dislodgment events, extravasation, infiltration detection (e.g., by monitoring tissue surrounding vasculature 601), thrombusdevelopment, phlebitis (visual or correlated cumulative movement), patency indicators, blood flow characteristics (e.g., by using doppler to detect velocity and / or volume of blood flowing into catheter 102), fluid administration flow characteristics (e.g., by using doppler to detect velocity, volume, direction, and / or duration of fluid flow), procedural events (e g., flush, draw, fluid administration), and / or line draw tubing, probe or sensor position in the vein or relative to the distal tip of the catheter or physiological feature (e.g., thrombus, valve, wall, branch, etc.).

[0071] Vascular access system 500 may provide a display including indicators of any of the above-mentioned information and may provide corresponding alerts. For example, base unit 512 or a monitoring device 513 may be configured to output a visual, audible, tactile, or digital alert when a condition or event is detected from the ultrasound images.

[0072] Figure 8 provides an example of how base unit 512 (or possibly monitoring device 513) could be configured to generate display content from images generated by an imaging device 210. This display content can include any of the above-described information, indicators, status, events, alerts, etc. (collectively “parameters”). Figure 7 is one example of display content.

[0073] Base unit 512 may be configured to receive images from imaging device 210 continuously, periodically, on demand, etc. Base unit 512 may include an image processor 512a that is configured to process the images to generate processed image data. This processed image data can be input to an artificial intelligence engine 512b that may be configured to detect and / or generate parameters from the processed image data. The parameters along with the images can be provided to a display module 512c that can generate the display content that includes the images and the parameters.

[0074] In some embodiments, image processor 512a can be configured to determine from an image or sequence of images various status information such as catheter geometry or positioninformation or the presence of a thrombus, kink, or other blockage. In some embodiments, artificial intelligence engine 512b can be trained to detect when parameters are present in a stream of images. For example, artificial intelligence engine 512b could detect when a sequence of images is indicative of a flush event, a draw event, the occurrence of extravasation, a dislodgement or movement event, etc. In some embodiments, artificial intelligence engine 512b could be used to predict the development or increasing risk of a potential complication or event. For example, artificial intelligence engine 512b could process images to detect that the catheter purchase is changing or decreasing over time. If this trend is detected or a threshold purchase is reached (e.g., when less than some percentage of catheter length remains in the vein), artificial intelligence engine 512b could cause an alert to be triggered so that a clinician can prevent failure of the catheter.

[0075] In some embodiments, artificial intelligence engine 512b (or another artificial intelligence solution) could be used to automatically detect a depth of distal tip I l la from images generated by imaging device(s) 210. The detected depth could then be used to enhance the accuracy of the images. For example, to facilitate the use of C-mode ultrasound, imaging device 210 could generate images at preset depths and then artificial intelligence engine 512b could evaluate the images to identify which image(s) includes catheter 111. The known depth of the identified image(s) could then be used as the depth for generating further C-mode ultrasound images.

[0076] Figures 9A-9C provide additional examples of a vascular access system 900 that may be used when one or more embodiments of the present disclosure are implemented. Vascular access system 900 may include vascular access device 100 and securement dressing 200 as described above as well as a monitoring assembly, such as monitoring assembly 910. Amonitoring assembly may include any or all of an ultrasound probe, a sensor array, or a vascular probe assembly. The monitoring assembly can be employed to continuously monitor vascular access device 100. In some embodiments, this continuous monitoring may encompass before, during and after the insertion of the catheter. In some embodiments, images, readings and / or parameters generated by the monitoring assembly can be presented to clinicians, processed to automatically detect events, status, or other occurrences, stored for subsequent analysis, or otherwise used to enhance the continuity of care.

[0077] In Figure 9A, monitoring assembly 910 may include an ultrasound probe 911, a securing mechanism 912 for securing ultrasound probe 911 to the skin and / or to catheter 102, an electrical adapter 913 by which a cable 914 is connected to ultrasound probe 911, base unit 512, a sensor array that includes 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 assembly 920 by which various parameters can be sensed from within the vasculature. Figure 9A represents an embodiment in which base unit 512 has a wired connection (cable 914) with ultrasound probe 911 and sensors 917 and a wireless connection with vascular probe assembly 920. In Figure 9B, monitoring assembly 910 includes a wireless adapter 916 in place of cable 914 such that base unit 512 has a wireless connection with ultrasound probe 911, sensors 917 and vascular probe assembly 920. In Figure 9C, monitoring assembly 910 includes a cable 919 that connects vascular probe assembly 920 to electrical adapter 913 and therefore represents an embodiment where vascular probe assembly 920 has a wired connection. Accordingly, any arrangement of wireless and / or wired connection(s) could be used in some embodiments.

[0078] In some embodiments, securing mechanism 912 may be an adhesive fdm on the underside of ultrasound probe 911 that may be used to adhere ultrasound probe 911 directly to apatient’s skin overtop catheter 102. In some embodiments, securing mechanism 912 can be a mechanical connection between ultrasound probe 911 and catheter adapter 101 and / or catheter 102. In some embodiments, electrical adapter 913 may be separable from ultrasound probe 911, while in other embodiments, electrical adapter 913 may be integrated with ultrasound probe 911. In some embodiments, electrical adapter 913 can include one or more connectors by which sensors 917 may be selectively connected to form the sensor array. In some embodiments, one or more sensors 917 may be integrated into electrical adapter 913. In some embodiments, one or more sensors 917 may be integrated into securement dressing 200.

[0079] Base unit 512 can be any device that includes circuitry for communicating with ultrasound probe 911, each sensor 917 in the sensor array, and vascular probe assembly 920. In some embodiments, base unit 512 may provide power to ultrasound probe 911, each sensor 917, and / or vascular probe assembly 920. In some embodiments, base unit 512 may directly process images received from ultrasound probe 911 and readings from sensor / s) 917 and / or vascular probe assembly 920, while in other embodiments, base unit 512 may receive images from ultrasound probe 911 and readings from sensor(s) 917 and / or vascular probe assembly 920 and forward the images and / or readings to another device for processing. In some embodiments, base unit 512 may include user input elements to allow a user (e.g., a clinician and / or the patient) to control ultrasound probe 911, sensor(s) 917, and / or vascular probe assembly 920. In some embodiments, base unit 512 may be connected to one or more other devices to allow users of the one or more other devices to control ultrasound probe 91 1, sensor(s) 917 and / or vascular probe assembly 920.

[0080] In some embodiments, ultrasound probe 911 may be integrated into securement dressing200. In other embodiments, ultrasound probe 911 may be separate from securement dressing 200.In such embodiments, ultrasound probe 911 may be placed overtop catheter 102 and thensecurement dressing 200 may be placed overtop ultrasound probe 911 , sensor(s) 917, and catheter adapter 101. In any case, ultrasound probe 911 can be positioned on the patient’s skin so that it is overtop the distal tip of catheter 102 when catheter 102 is inserted into the patient’s vasculature. Sensor(s) 917 may also be placed overtop or near the distal tip of catheter 102.

[0081] In some embodiments, vascular probe assembly 920 can be integrated into vascular access device 100. In some embodiments, vascular probe assembly 920 can be configured to couple to vascular access device 100 via near patient access port 105. Vascular probe assembly 920 can comprise a probe 923 and one or more sensors 923a positioned on a distal end of probe 923. Vascular probe assembly 920 can also include an electrical adapter 921 by which sensors 923a can be electrically coupled to monitoring assembly 910.

[0082] A vascular access probe could have a variety of configurations. Figures 11 A and 1 IB provide an example of how vascular probe assembly 920 could be configured in some embodiments. As shown, vascular probe assembly 920 may include an electrical adapter 921 at a proximal end and a probe 923 that extends distally from electrical adapter 921. One or more sensors 923a may be positioned at a distal end of probe 923 so that they will be positioned within the patient’s vasculature during use. Sensor(s) 923a can be electrically connected to electrical adapter 921 (e.g., via one or more wires, traces, or other electrical connection medium). Vascular probe assembly 920 may include a housing 924 and a coupler 922 at the distal end of housing 924. Coupler 922 can be configured to couple to near patient access port 105. A slider 925 may be secured to housing 924 and configured to slide probe 923 from an initial proximal position (e.g., as shown in Figure 11 A) to a distal deployed position (e.g., as shown in Figure 11B). In some embodiments, housing 924 may be configured to separate from coupler 922 to expose electricaladapter 921 . Tn some embodiments, housing 924 may be configured to separate only after slider 925 has been slid distally to deploy probe 923.

[0083] Figures 12A and 12B provide another example of how vascular probe assembly 920 can be configured in some embodiments. In these embodiments, vascular probe assembly 920 also includes an extension 926 between probe 923 and electrical adapter 921. Wire(s), trace(s), or other electrical connection medium can extend through extension 926 to allow sensor(s) 923a to be powered and / or controlled via electrical adapter 921. As represented in Figure 12B, extension 926 may allow electrical adapter 921 to be positioned away from near patient access port 105.

[0084] In embodiments where monitoring assembly 910 includes vascular probe assembly 920, monitoring assembly 910 may also include a hub 915 that can be connected to electrical adapter 921. Hub 915 can be configured to provide power to and / or to enable communication with sensor(s) 923a. For example, hub 915 may comprise a wireless interface which can enable communication between sensor(s) 923a and base unit 512 (or possibly monitoring device(s) 513). In some embodiments, hub 915 may include one or more batteries for powering sensor(s) 923a. In some embodiments, hub 915 could form a wired interface by which sensor(s) 923a are connected to electrical adapter 913 (or possibly connected directly to cable 914). In some embodiments, communications and / or power may delivered via cable 919. In Figure 12B, hub 915 provides a connection point for cable 914 and represents an embodiment where monitoring assembly 910 includes only vascular probe assembly 920.

[0085] Figures 10A-10C provide additional examples of how vascular access system 900 may be configured in some embodiments. In Figure 10A, monitoring assembly 910 includes a hub 915 that is coupled directly to electrical adapter 921 of vascular probe assembly 920 and a cable 919that is connected to electrical adapter 913. Also, in Figure 10A, window 203 in securement dressing 200 is expanded beyond the insertion site and encompasses ultrasound patch 911.

[0086] In some embodiments, hub 915 as represented in Figure 10A may be configured to interface with base unit 512, while in other embodiments, hub 915 may function as base unit 512. Hub 915 may provide power to and / or communicate with ultrasound probe 911 via cable 919.

[0087] Hub 915 as represented in Figure 10A also includes an integrated display by which one or more parameters may be displayed (e.g., heart rate, body temperature, and blood oxygen level). In some embodiments, such parameters could be derived from readings obtained by sensors 923a. In embodiments where monitoring assembly 910 includes a sensor array, such parameters could be derived from readings obtained by sensors 917. In some embodiments, this display could also or alternatively be configured to display images and / or parameters generated by ultrasound probe 911. Accordingly, this display can be used to present at the point of care any information or content generated by monitoring assembly 910. Hub 915 may also communicate with monitoring device(s) 513, whether directly or via base unit 512.

[0088] In Figure 10B, vascular access system 900 is similar to what is shown in Figure 10A. However, hub 915 does not include a display and forms a wired interface, via cable 919, to electrical adapter 913. Electrical adapter 913 also forms a wired interface, via cable 914, to base unit 512. In Figure 10C, vascular access system 900 is similar to what is shown in Figure 10B. However, cable 914 is connected between hub 915 and base unit 512. In Figures 10A-10C, monitoring assembly 910 does not include a sensor array. However, a sensor array could be included in any embodiments represented by these figures.

[0089] Monitoring device(s) 513 can represent any device having a display on which images generated by ultrasound probe 911 may be displayed and / or on which information obtained fromsuch images and / or readings from sensor(s) 917 and / or sensor(s) 923a may be displayed. As examples, monitoring device(s) 513 could include a smart phone, a tablet, a laptop, a desktop, a thin client, a television, a dedicated display device, an infusion pump, a patient vital sign monitor, an arterial monitor, an ultrasound system visual display, etc. In some embodiments, a monitoring device 513 could function as base unit 512. A monitoring device 513 could also be configured to interface with one or more separate computing systems such as a system for storing patient data.

[0090] In embodiments that include wireless adapter 916, wireless adapter 916 may be configured to transmit images generated by ultrasound probe 9111 and / or readings from sensor(s) 917 and / or sensor(s) 923a to base unit 512 or possibly to monitoring device(s) 513. Wireless adapter 916 may also include batteries for powering ultrasound probe 911, sensor(s) 917, and / or vascular probe assembly 920. In some embodiments, wireless adapter 916 may be integrated into electrical adapter 913, while in other embodiments, wireless adapter 916 may be selectively coupled to electrical adapter 913.

[0091] Figures 9A-10C provide examples where vascular access system 900 includes a peripheral intravenous catheter. However, a vascular access system could be used with central venous catheters, peripherally inserted central catheters, midline catheters, arterial catheters, ports, venipuncture, sub-cutaneous access devices, or other indwelling tube, probe, sensor, or instrument.

[0092] In accordance with one or more embodiments of the present disclosure, any of the above-described vascular access systems or any other suitable vascular access system could be used to perform site assessment and / or documentation for a vascular access device. For example, such vascular access systems could be used intermittently or continuously to assist in placement of a vascular access device and to assess the current state of the indwelling vascular access device. In some embodiments, the vascular access systems could be configured to leverage prior state,established clinical standards, and / or correlated clinical data for predictive detection, identification, and / or diagnosis of an emerging risk of catheter-related complication and / or the detection, identification and / or diagnosis of an actualized complication. In short, embodiments of the present disclosure enable vascular access systems to be leveraged to perform an objective assessment of a vascular access device based on clinical indications.

[0093] As introduced above with reference to Figure 8, in some embodiments, a vascular access system may be configured to use artificial intelligence models for identifying procedural events, device or site manipulations, acute failure events or other site changes that may affect the continuous viability of the vascular access device and placement (generally “Indwell Events or Status”). A vascular access system may also be used to automatically document or chart vascular access data related to the Indwell Events or Status.

[0094] In some embodiments artificial intelligence diagnostic and predictive models may be built, informed and refined based on correlating current device, site, and patient assessment status to clinically observed catheter complications and failures, as well as to prior device, site, and patient assessment status and history, patient history, disease state, applicable clinical standards (e g., the INS standards), hospital policies and standards, clinician desired limits and thresholds, payer or insurance carrier standards with applicable safety factors, etc. Thresholds and alert limits may be tiered and set according to the listed or other determined standards and limits.

[0095] Figures 13A-13C provide an example of how vascular access device indwell assessment and documentation may be implemented in accordance with one or more embodiments. In the depicted embodiments, an artificial intelligence (Al) system 1300 is employed and includes a data processor 1301, an Al database 1302, a model trainer 1303, and Al engine 512b. Al system 1300 may typically be separate from but interfaced with many different vascular access systems.However, in some embodiments, Al system 1300 could be at least partially integrated into a vascular access system.

[0096] Figure 13A represents how Al system 1300 can generate a labeled dataset from vascular access data for use in training one or more Al models that may be used to perform vascular access indwell assessment. 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 manners described above. For example, vascular access systems (e.g., base units 512) could be configured to report all vascular access data they generate to data processor 1301. In this way, data processor 1301 could gather a large vascular access dataset which can contain vascular access data indicative of many different Indwell Events or Status.

[0097] In some embodiments, as part of this reporting of vascular access data, the vascular access system(s) (e.g., Al Engine 512b) could also be configured to report any events, detections, alerts, etc. that it may have been generated for a particular set of vascular access data (e.g., in a similar manner as is represented in Figure 8). Also, in some embodiments, the vascular access system(s) could be configured to receive user input to confirm any events, detections, alerts, etc. that may be associated with the vascular access data, and in such cases, this confirmation input can also be provided to data processor 1301.

[0098] Data processor 1301 can process the vascular access data it receives to generate a labeled dataset. For example, data processor 1301 can associate labels representing Indwell Events or Status with the vascular access data (or feature in the vascular access data) indicative of such Indwell Events or Status. For example, the labeled dataset may associate a label representing the development of a thrombus with many instances of image data indicative of the development of athrombus. This labeled dataset can be stored in Al database 1302. Tn some embodiments, the process represented in Figure 13 A could be continuously performed as vascular access systems are used to update and refine the labeled dataset.

[0099] In some embodiments, a labeled dataset may be generated using vascular access data pertaining to a particular classification of patients (e.g., children or elderly), pertaining to a particular location or entity (e.g., a particular hospital or a particular provider’s hospitals), or pertaining to any other classification or grouping. This may allow Al models to be trained for these particular classifications.

[0100] Figure 13B represents how a model trainer 1303 can use the labeled dataset to generate and train an Al model which in turn can be provided to Al engine 512b. For example, model trainer 1303 can create and train an Al model that can be leveraged to automatically and in realtime detect Indwell Events or Status from vascular access data.

[0101] Figure 13C represents how Al engine 512b can use the Al model to perform vascular access device indwell assessment and documentation. As shown, a vascular access system can provide processed image data, sensor readings, and / or other vascular access data (whether intermittently or continuously as described above) to Al engine 512b. Al engine 512b can evaluate this vascular access data against the Al model to assess the vascular access device. For example, Al engine 512b could analyze the processed image data against the Al model to determine whether the processed image data exhibits any of the characteristics indicative of Indwell Events or Status.

[0102] In some embodiments, AT engine 512b may detect Indwell Events or Status or make a corresponding recommendation based only on the evaluation of the vascular access data against the AT model. In other embodiments, Al engine 512b may evaluate other criteria to make such detections or recommendations. In some embodiments, these criteria could include applicableclinical standards, hospital policies and standards, clinician desired limits and thresholds, payer or insurance carrier standards with applicable safety factors, the patient’s history or disease state, etc. For example, based on an evaluation of the vascular access data against the Al model, Al engine 512b could detect that the vascular access device has not been flushed for a certain amount of time and could then employ hospital -specific criteria to determine whether to generate a recommendation to flush the vascular access device. As another example, based on an evaluation of the vascular access data against the Al model, Al engine 512b could detect that the vascular access device is partially occluded and could then employ applicable standards to determine whether to generate an alert that the vascular access device should be replaced. In some embodiments, the criteria could specify thresholds and limits for determining when or which type of notification should be generated.

[0103] Based on its evaluation of the vascular access data against the Al model and when it detects Indwell Events or Status, Al engine 512b could output appropriate Al-generated notifications which could then be displayed on a monitoring device 513 or otherwise output in the vascular access system. In this way, Al engine 512b can automatically assess the vascular access device and provide appropriate notifications to facilitate and improve the treatment of the patient.

[0104] Figure 13C also represents that Al engine 512b can automatically document any Indwell Events or Status in the patient’s record. In this way, the Indwell Events and Status can be automatically correlated with the patient’s pre-insertion and / or post-insertion assessments, the patient’s historical vascular accesses, etc. In some embodiments, this documentation could include labeling the portion of the vascular access data that was determined to be indicative of the Indwell Event or Status so that the Al model could be customized for the particular patient in future use cases.

[0105] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.

Claims

CLAIMSWhat is claimed:

1. A method for performing vascular access device assessment comprising: receiving, at an artificial intelligence (Al) engine of a vascular access system, vascular access data pertaining to a vascular access device having a catheter that is inserted into a patient’s vasculature; evaluating, by the Al engine, the vascular access data against an Al model to detect one or more indwell events or status; and generating, by the Al engine, one or more notifications indicative of the one or more indwell events or status.

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

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

4. The method of claim 2, wherein evaluating the vascular access data against the Al model to detect the one or more indwell events or status comprises determining that the imaging data includes one or more characteristics indicative of the one or more indwell events or status.

5. The method of claim 4, wherein determining that the imaging data includes one or more characteristics indicative of the one or more indwell events or status comprises determining that the imaging data matches labeled vascular access data on which the Al model was trained.

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

7. The method of claim 1, further comprising: updating a record of the patient to include the one or more indwell events or status.

8. The method of claim 1, further comprising: using the vascular access data to update a labeled dataset from which the Al model was trained.

9. The method of claim 1, wherein evaluating the vascular access data against an Al model to detect one or more indwell events or status comprises considering additional criteria.

10. The method of claim 9, wherein the additional criteria includes one or more of: one or more policies; one or more standards; one or more safety factors; history of the patient; or a disease or state of the disease of the patient.

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

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

13. The method of claim 1, further comprising: receiving, at a data processor, other vascular access data from other vascular access systems; generating, by the data processor, a labeled dataset from the other vascular access data; and training, by a model trainer, the Al model using the labeled dataset.

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

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 an AT model;receiving vascular access data pertaining to a vascular access device having a catheter that is inserted into a patient’s vasculature, the vascular access data comprising imaging data of the catheter; and using the Al model to assess the catheter.

16. The computer storage media of claim 15, wherein using the Al model to assess the catheter comprises determining, from the Al model, that the vascular access data is indicative of one or more indwell events or status.

17. The computer storage media of claim 16, wherein the method further comprises: generating one or more notifications for the one or more indwell events or status; and documenting the one or more indwell events or status in a record of the patient.

18. A vascular access system comprising: a vascular access device comprising a catheter; a monitoring assembly comprising an imaging device that is configured to be positioned overtop the catheter when the catheter is inserted into a patient’s vasculature; a base unit that is configured to receive vascular access data comprising imaging data from the monitoring assembly; and an Al engine that is configured to evaluate the vascular access data against an Al model to detect one or more indwell events or status 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 for presenting one or more notifications pertaining to the one or more indwell events or status.

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