Vascular access system and method for continuous monitoring

Abstract

Vascular access systems and methods are provided for continuous monitoring. A vascular access system can include a vascular access device, a monitoring assembly, a securement dressing, a base unit, and one or more monitoring devices. The monitoring assembly may include an ultrasound probe that can be positioned overtop a catheter that is inserted into a patient's vasculature. The monitoring assembly may include a sensor array for sensing parameters from the surface of the patient's skin. The monitoring assembly may include a vascular probe assembly for sensing parameters from within the vasculature. Images from the ultrasound probe and / or parameters sensed by the sensor array and / or vascular probe assembly can be processed to generate parameters representing status, events, or other information about the catheter. Display content including the images and the parameters can be provided to the monitoring devices.

Description

VASCULAR ACCESS SYSTEM AND METHODFOR CONTINUOUS MONITORINGBACKGROUND

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

[0002] 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] 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.

[0004] Figure 1 illustrates a prior art piezoelectric transducer array for performing ultrasound10 (or ultrasound probe 10). Ultrasound probe 10 is conformable and can therefore be worn on the skin and used to perform deep tissue imaging.

[0005] 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

[0006] The present disclosure relates generally to vascular access devices, systems, and methods. In particular, the present disclosure relates to vascular access systems and methods for continuous monitoring. A vascular access system can include a vascular access device, a monitoring assembly, a securement dressing, a base unit, and one or more monitoring devices. The monitoring assembly may include an ultrasound probe that can be positioned overtop a catheter that is inserted into a patient’ s vasculature. The monitoring assembly may include a sensor array for sensing parameters from the surface of the patient’s skin. The monitoring assembly may include a vascular probe assembly for sensing parameters from within the vasculature. Images from the ultrasound probe and / or parameters sensed by the sensor array and / or vascular probe assembly can be processed to generate parameters representing status, events, or other information about the catheter. Display content including the images and the parameters can be provided to the monitoring devices.

[0007] In some embodiments, a vascular access system may include a vascular access device having a catheter, a monitoring assembly, and a base unit. The monitoring assembly may includean ultrasound probe that is configured to be positioned overtop the catheter when the catheter is inserted into a patient’s vasculature. The monitoring assembly may also include a vascular probe assembly having one or more sensors that are configured to be inserted into the patient’s vasculature. The base unit may be configured to receive images from the ultrasound probe and readings from the one or more sensors of the vascular probe assembly.

[0008] In some embodiments, the monitoring assembly may include a sensor array having one or more sensors that are configured to be positioned on the patient’s skin and the base unit may be configured to receive readings from the one or more sensors of the sensor array.

[0009] In some embodiments, one or more of the ultrasound probe, the vascular probe assembly, or the sensor array may be configured to communicate with the base unit via a wired connection.

[0010] In some embodiments, one or more of the ultrasound probe, the vascular probe assembly, or the sensor array may be configured to communicate with the base unit via a wireless connection.

[0011] In some embodiments, the vascular access system may include a securement dressing that is configured to secure the ultrasound probe overtop the catheter.

[0012] In some embodiments, the base unit may be configured to generate display content from the images and the readings and transmit the display content to one or more monitoring devices.

[0013] In some embodiments, the base unit may be configured to generate one or more parameters from the images and the readings and to include the one or more parameters in the display content.

[0014] In some embodiments, the parameters may include catheter geometry or position information.

[0015] In some embodiments, the parameters may include one or more of catheter movement or displacement, catheter kinking, dislodgment events, extravasation, infiltration detection, thrombus development, phlebitis, patency indicators, blood flow characteristics, fluid administration flow characteristics, procedural events, line draw tubing, probe or sensor position, SPO2, temperature, movement, falls, pH, blood gases, blood pressure, lactate, EKG, or pulse.

[0016] In some embodiments, the vascular probe assembly may include a probe on which the one or more sensors are positioned.

[0017] In some embodiments, the vascular probe assembly may include an electrical adapter.

[0018] In some embodiments, the vascular probe assembly may include a hub that is coupled to the electrical adapter.

[0019] In some embodiments, the hub may include a display.

[0020] In some embodiments, the vascular probe assembly may include a coupler by which the vascular probe assembly is coupled to the vascular access device and a housing that separates from the coupler to expose the electrical adapter.

[0021] In some embodiments, a method for using a vascular access system may include inserting a catheter of a vascular access device into a patient’s vasculature, positioning an ultrasound probe of a monitoring assembly on the patient’s skin overtop a portion of the catheter that is inserted into the patient’s vasculature, positioning a probe of a vascular probe assembly in the patient’ s vasculature via the vascular access device, and establishing a connection between the ultrasound probe and a base unit and between one or more sensors of the ultrasound probe assembly and the base unit to thereby enable the base unit to receive ultrasound images from the ultrasound probe where the ultrasound images capture the portion of the catheter that is insertedinto the patient’s vasculature and to receive readings from the one or more sensors while the one or more sensors are within the patient’s vasculature.

[0022] In some embodiments, the connection may be wired or wireless.

[0023] In some embodiments, the method may also include placing a securement dressing overtop the ultrasound probe and a catheter adapter from which the catheter extends.

[0024] In some embodiments, a method for monitoring a catheter may include receiving, from an ultrasound probe that is positioned overtop a catheter that is inserted into a patient’ s vasculature, images that capture the catheter, receiving readings from one or more sensors of a vascular probe assembly that are inserted into the patient’s vasculature while the catheter is inserted into the patient’ s vasculature, processing the images and the readings to determine one or more parameters, and generating display content that includes the one or more parameters.

[0025] In some embodiments, processing the images and the readings to determine one or more parameters may include processing the images to determine geometry or position information of the catheter, line draw tubing, a probe or a sensor and processing the readings to determine pH, blood gases, blood pressure, temperature, lactate, EKG, or pulse.

[0026] In some embodiments, the method may also include presenting at least some of the display content on a display integrated into the vascular probe assembly.

[0027] In some embodiments, the ultrasound probe may be used to monitor placement or proper positioning of the vascular probe within the vein or artery.

[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 illustrates a prior art piezoelectric transducer array for performing ultrasound;

[0031] Figure 2A provides an example of a vascular access system that is configured in accordance with one or more embodiments;

[0032] Figure 2B provides another example of a vascular access system that is configured in accordance with one or more embodiments;

[0033] Figure 2C provides another example of a vascular access system that is configured in accordance with one or more embodiments;

[0034] Figure 3A provides another example of a vascular access system that is configured in accordance with one or more embodiments;

[0035] Figure 3B provides another example of a vascular access system that is configured in accordance with one or more embodiments;

[0036] Figure 3C provides another example of a vascular access system that is configured in accordance with one or more embodiments;

[0037] Figures 4A and 4B provide an example of a vascular probe assembly that may form part of a vascular access system in accordance with one or more embodiments;

[0038] Figures 5A and 5B provide another example of a vascular probe assembly that may form part of a vascular access system in accordance with one or more embodiments;

[0039] Figure 6A is a partial cross-sectional view of a vascular access system that is configured in accordance with one or more embodiments when placed on the skin;

[0040] Figure 6B is a transverse view of a vein in which a catheter is inserted that can be generated by a vascular access system that is configured in accordance with one or more embodiments;

[0041] Figure 6C is a cross-sectional view of a vein in which a catheter is inserted that can be generated by a vascular access system that is configured in accordance with one or more embodiments;

[0042] Figure 7 is an example display that can be generated by a vascular access system that is configured in accordance with one or more embodiments; and

[0043] Figure 8 provides an example of electronic components that a base unit or monitoring device of a vascular access system may include in one or more embodiments.DESCRIPTION OF EMBODIMENTS

[0044] Referring now to Figures 2A and 2B, in some embodiments, a vascular access system 50 may include a vascular access device 100, a monitoring assembly 200, a securement dressing 300, and one or more monitoring devices 400. Vascular access device 100 may include a catheter adapter 101, a catheter 102 that extends distally from catheter adapter 101, a securement platform 103 (e.g., wings that extend outwardly from catheter adapter 101), a needle access port 104 by which an introducer needle (not shown) can be inserted through catheter adapter 101 and catheter102, a near patient access port 105 which may be connected to a side port of catheter adapter 101,extension tubing 106 having a clamp 107 and to which luer adapter 108 is connected, and an access port 109 coupled to the luer adapter 108. This is only one example of various different configurations of vascular access devices that may be used in vascular access systems that are configured in accordance with embodiments of the present disclosure.

[0045] A monitoring assembly configured in accordance with embodiments of the present disclosure 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.

[0046] In Figure 2A, monitoring assembly 200 may include an ultrasound probe 201 , a securing mechanism 202 for securing ultrasound probe 201 to the skin and / or to catheter 102, an electrical adapter 203 by which a cable 204 is connected to ultrasound probe 201, a base unit 205, a sensor array that includes one or more sensors 207 for sensing parameters from the surface of the patient’ s skin, one or more status indicators 209 and a vascular probe assembly 210 by which various parameters can be sensed from within the vasculature. Figure 2A represents an embodiment in which base unit 205 has a wired connection (cable 204) with ultrasound probe 201 and sensors 207 and a wireless connection with vascular probe assembly 210. In Figure 2B, monitoring assembly 200 includes a wireless adapter 206 in place of cable 204 such that base unit 205 has a wireless connection with ultrasound probe 201, sensors 207 and vascular probe assembly 210. InFigure 2C, monitoring assembly 200 includes a cable 208 that connects vascular probe assembly210 to electrical adapter 203 and therefore represents an embodiment where vascular probe assembly 210 has a wired connection. Accordingly, any arrangement of wireless and / or wired connection(s) could be used in some embodiments.

[0047] In some embodiments, securing mechanism 202 may be an adhesive film on the underside of ultrasound probe 201 that may be used to adhere ultrasound probe 201 directly to a patient’s skin overtop catheter 102. In some embodiments, securing mechanism 202 can be a mechanical connection between ultrasound probe 201 and catheter adapter 101 and / or catheter 102. In some embodiments, electrical adapter 203 may be separable from ultrasound probe 201, while in other embodiments, electrical adapter 203 may be integrated with ultrasound probe 201. In some embodiments, electrical adapter 203 can include one or more connectors by which sensors 207 may be selectively connected to form the sensor array. In some embodiments, one or more sensors 207 may be integrated into electrical adapter 203. In some embodiments, one or more sensors 207 may be integrated into securement dressing 300.

[0048] Base unit 205 can be any device that includes circuitry for communicating with ultrasound probe 201, each sensor 207 in the sensor array, and vascular probe assembly 210. In some embodiments, base unit 205 may provide power to ultrasound probe 201, each sensor 207, and / or vascular probe assembly 210. In some embodiments, base unit 205 may directly process images received from ultrasound probe 201 and readings from sensor(s) 207 and / or vascular probe assembly 210, while in other embodiments, base unit 205 may receive images from ultrasound probe 201 and readings from sensor(s) 207 and / or vascular probe assembly 210 and forward the images and / or readings to another device for processing. In some embodiments, base unit 205 may include user input elements to allow a user (e.g., a clinician and / or the patient) to control ultrasound probe 201, sensor(s) 207, and / or vascular probe assembly 210. In some embodiments,base unit 205 may be connected to one or more other devices to allow users of the one or more other devices to control ultrasound probe 201, sensor(s) 207 and / or vascular probe assembly 210.

[0049] Securement dressing 300 may be sized and shaped to cover and secure ultrasound probe 201, sensor(s) 207, and catheter adapter 101 against the patient’s skin. For example, in some embodiments, securement dressing 300 may fully cover catheter adapter 101 and may include an opening through which extension tubing 106 extends. The underside of securement dressing 300 may be adhesive to prevent securement dressing 300 from moving once placed on the skin. In some embodiments, an opening 301 may be formed in securement dressing 300 to correspond with the insertion site of catheter 102 and may allow placement of an adhesive 302 for sealing the insertion site.

[0050] In some embodiments, ultrasound probe 201 may be integrated into securement dressing 300. In other embodiments, ultrasound probe 201 may be separate from securement dressing 300. In such embodiments, ultrasound probe 201 may be placed overtop catheter 102 and then securement dressing 300 may be placed overtop ultrasound probe 201, sensor(s) 207, and catheter adapter 101. In any case, ultrasound probe 201 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) 207 may also be placed overtop or near the distal tip of catheter 102.

[0051] In some embodiments, vascular probe assembly 210 can be integrated into vascular access device 100. In some embodiments, vascular probe assembly 210 can be configured to couple to vascular access device 100 via near patient access port 105. Vascular probe assembly 210 can comprise a probe 213 and one or more sensors 213a positioned on a distal end of probe 213. Vascular probe assembly 210 can also include an electrical adapter 211 by which sensors213a can be electrically coupled to monitoring assembly 200.

[0052] A vascular access probe configured in accordance with embodiments of the present disclosure could have a variety of configurations. Figures 4A and 4B provide an example of how vascular probe assembly 210 can be configured in some embodiments. As shown, vascular probe assembly 210 may include an electrical adapter 211 at a proximal end and a probe 213 that extends distally from electrical adapter 211. One or more sensors 213a may be positioned at a distal end of probe 213 so that they will be positioned within the patient’s vasculature during use. Sensor(s) 213a can be electrically connected to electrical adapter 211 (e.g., via one or more wires, traces, or other electrical connection medium). Vascular probe assembly 210 may include a housing 214 and a coupler 212 at the distal end of housing 214. Coupler 212 can be configured to couple to near patient access port 105. A slider 215 may be secured to housing 214 and configured to slide probe 213 from an initial proximal position (e.g., as shown in Figure 4A) to a distal deployed position (e.g., as shown in Figure 4B). In some embodiments, housing 214 may be configured to separate from coupler 212 to expose electrical adapter 211. In some embodiments, housing 214 may be configured to separate only after slider 215 has been slid distally to deploy probe 213.

[0053] Figures 5 A and 5B provide another example of how vascular probe assembly 210 can be configured in some embodiments. In these embodiments, vascular probe assembly 210 also includes an extension 216 between probe 213 and electrical adapter 211. Wire(s), trace(s), or other electrical connection medium can extend through extension 216 to allow sensor(s) 213a to be powered and / or controlled via electrical adapter 211. As represented in Figure 5B, extension 216 may allow electrical adapter 211 to be positioned away from near patient access port 105.

[0054] In embodiments where monitoring assembly 200 includes vascular probe assembly 210, monitoring assembly 200 may also include a hub 217 that can be connected to electrical adapter211. Hub 217 can be configured to provide power to and / or to enable communication withsensor(s) 213a. For example, in Figures 2A and 2B, hub 217 comprises a wireless interface which can enable communication between sensor(s) 213a and base unit 205 (or possibly monitoring device(s) 400). In some embodiments, hub 217 may include one or more batteries for powering sensor(s) 213a. As another example, in Figure 2C, hub 217 comprises a wired interface by which sensor(s) 213a are connected to electrical adapter 203 (or possibly connected directly to cable 204). In some embodiments, communications and / or power may delivered via cable 208. In Figure 5B, hub 217 provides a connection point for cable 204 and represents an embodiment where monitoring assembly 200 includes only vascular probe assembly 210.

[0055] Figures 3A-3C provide additional examples of how vascular access system 50 may be configured in some embodiments. In Figure 3 A, monitoring assembly 200 includes a hub 217 that is coupled directly to electrical adapter 211 of vascular probe assembly 210 and a cable 208 that is connected to electrical adapter 203. Also, in Figure 3A, opening 301 in securement dressing 300 is expanded beyond the insertion site and encompasses ultrasound patch 201.

[0056] In some embodiments, hub 217 as represented in Figure 3 A may be configured to interface with base unit 205, while in other embodiments, hub 217 may function as base unit 205. Hub 217 may provide power to and / or communicate with ultrasound probe 201 via cable 208.

[0057] Hub 217 as represented in Figure 3A also includes an integrated display 218 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 213a. In embodiments where monitoring assembly 200 includes a sensor array, such parameters could be derived from readings obtained by sensors 207. In some embodiments, display 218 could also or alternatively be configured to display images and / or parameters generated by ultrasound probe 201. Accordingly, display 218 can be used to present at the point of care any informationor content generated by monitoring assembly 200. Hub 217 may also communicate with monitoring device(s) 400, whether directly or via base unit 205.

[0058] In Figure 3B, vascular access system 50 is similar to what is shown in Figure 3A. However, hub 217 does not include display 218 and forms a wired interface, via cable 208, to electrical adapter 203. Electrical adapter 203 also forms a wired interface, via cable 204, to base unit 205. In Figure 3C, vascular access system 50 is similar to what is shown in Figure 3B. However, cable 204 is connected between hub 217 and base unit 205. In Figures 3A-3C, monitoring assembly 200 does not include a sensor array. However, a sensor array could be included in any embodiments represented by these figures.

[0059] Monitoring device(s) 400 can represent any device having a display on which images generated by ultrasound probe 201 may be displayed and / or on which information obtained from such images and / or readings from sensor(s) 207 and / or sensor(s) 213a may be displayed. As examples, monitoring device(s) 400 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 400 could function as base unit 205. A monitoring device 400 could also be configured to interface with one or more separate computing systems such as a system for storing patient data.

[0060] In embodiments that include wireless adapter 206, wireless adapter 206 may be configured to transmit images generated by ultrasound probe 201 and / or readings from sensor(s) 207 and / or sensor(s) 213a to base unit 205 or possibly to monitoring device(s) 400. Wireless adapter 206 may also include batteries for powering ultrasound probe 201, sensor(s) 207, and / or vascular probe assembly 210. In some embodiments, wireless adapter 206 may be integrated intoelectrical adapter 203, while in other embodiments, wireless adapter 206 may be selectively coupled to electrical adapter 203.

[0061] Figures 2A-3C provide examples where vascular access system 50 includes a peripheral intravenous catheter. However, a vascular access system configured in accordance with embodiments of the present disclosure 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.

[0062] Figure 6A is a partial cross-sectional view of vascular access system 50 when used on a patient. As shown, ultrasound probe 201 may be positioned via securing mechanism 202 on the patient’s skin overtop a distal tip 102a of catheter 102 when catheter 102 is inserted into the patient’s vasculature 600. Securement dressing 300, which may include opening 301, can be positioned overtop catheter adapter 101 and ultrasound probe 201 to retain this positioning of ultrasound probe 201 overtop distal tip 102a. In this position, ultrasound probe 201 can generate ultrasound images continuously, periodically, on demand, etc. of the portion of vasculature 600 within which catheter 102 extends including the surrounding tissue. For example, Figure 6B is an image that captures a transverse view of vasculature 600, catheter 102, and distal tip 102a, and Figure 6C is an image that captures a cross-sectional view of vasculature 600 and catheter 102.

[0063] Figure 7 provides an example of how images generated by ultrasound probe 201 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 205, any number of monitoring devices 400, and / or display 218. This display may include one or more views of catheter 102 within vasculature 600 such as the transverse view of Figure 6B and the cross-sectional view ofFigure 6C. The transverse view may allow a clinician to see how catheter 102 is extending intovasculature 600 and may therefore facilitate quickly determining if catheter 102 is inserted sufficiently, if distal tip 102a is positioned correctly, if there is any blockage, or any other condition that is capable of being detected via ultrasound. The cross-sectional view may allow a clinician to see how a particular portion of catheter 102 is positioned within vasculature 600 and may therefore facilitate quickly determining if catheter 102 may be excessively limiting blood flow through vasculature 600 or any other condition that is capable of being detected via ultrasound. In some embodiments, a user may be able to adjust the location of the views generated by ultrasound probe 201. For example, a user may be able to move the cross-sectional view along the length of catheter 102 to determine if there is excessive blockage at any portion along the length of catheter 102.

[0064] Figure 7 also illustrates that the display may include a variety of information that may be derived from the images that ultrasound probe 201 produces or from input. For example, the display includes an indicator 601a of the gauge of catheter 102 and an indicator 601b of the length of catheter 102. Indicators 601a and 601b could be obtained via user input or could be calculated from the images produced by ultrasound probe 201.

[0065] The display also includes indicators 602a, 602b, and 602c for different parameters. In some embodiments, these parameters could be selectable. For example, in Figure 7, indicator 602a provides information for when catheter 102 was last flushed. This last flush information could be calculated using the images produced by ultrasound probe 201. For example, doppler techniques could be applied to the image data to detect when fluid is flowing out through distal tip 102a, and in response to such a detection, base unit 205 (or a monitoring device 400) could store an indication that a flush has occurred at that time. In Figure 7, indicators 602b and 602c have not been selected. However, these indicators could be selected to display information for any of many different conditions, events, statuses, etc. as described below.

[0066] The display further includes indicators 603a and 603b that provide information about the portion of catheter 102 that is inside vasculature 600. Indicator 603a 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 603b defines the purchase of catheter 102 (i.e., the length of catheter 102 that is inside vasculature 501). The display additionally includes an indicator 604 defining a patency status of catheter 102 (i.e., whether catheter 102 can safely remain within vasculature 600). Base unit 205 (or a monitoring device 400) could calculate the patency status using the images provided by ultrasound probe 201 (e.g., to detect the extent to which catheter 102 and / or vasculature 600 around catheter 102 may be blocked).

[0067] As suggested above, vascular access system 50 can be configured to monitor and / or display information relating to the status of catheter 102, vasculature 600, or the surrounding tissue and a variety of associated physiological or procedural parameters by leveraging images that are provided by ultrasound probe 201. 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 600), thrombus development, 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, fluidadministration), 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.).

[0068] Additionally, readings from sensor(s) 207 and / or sensor(s) 213a can also or alternatively be leveraged to display information relating to the status of catheter 102, vasculature 600, or the surrounding tissue and a variety of associated physiological or procedural parameters. For example, sensor(s) 207 may be used to monitor infiltration, SPO2, temperature, movement, falls, etc. and sensor(s) 213a may be used to monitor pH, blood gases, blood pressure, lactate, temperature, EKG, pulse or other obtainable in-vascular parameter. Status indicator(s) 209 can be used to indicate the status of catheter 102 based on any one or more of the parameters derived from the readings / information generated by ultrasound probe 201, sensor(s) 207 and / or sensor(s) 213a.

[0069] Vascular access system 50 may provide a display including indicators of any of the above-mentioned information and may provide corresponding alerts. For example, display 218, base unit 205 or a monitoring device 400 may be configured to output a visual, audible, tactile, or digital alert when a condition or event is detected from the ultrasound images. In some embodiments, ultrasound probe 201, electrical adapter 203 or 211, cable 204 or 208, wireless adapter 206, hub 217, etc. could include one or more alerting mechanisms (e.g., LEDs, speakers, haptic units, etc.) to provide an alert.

[0070] Figure 8 provides an example of how base unit 205 (or possibly monitoring device 400) could be configured to generate display content from ultrasound images. 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.

[0071] Base unit 205 may be configured to receive ultrasound images from ultrasound probe201 continuously, periodically, on demand, etc. Base unit 205 may include an image processor205a that is configured to process the ultrasound images to generate processing image data. This processed image data can be input to an artificial intelligence engine 205b that may be configured to detect and / or generate parameters from the processed image data. The parameters along with the ultrasound images can be provided to a display module 205c that can generate the display content that includes the images and the parameters.

[0072] In some embodiments, image processor 205a can be configured to determine from an image or sequence of images various status information such as catheter geometry or position information or the presence of a thrombus, kink, or other blockage. In some embodiments, artificial intelligence engine 205b can be trained to detect when parameters are present in a stream of ultrasound images. For example, artificial intelligence engine 205b could detect when a sequence of ultrasound images is indicative of a flush event, a draw event, the occurrence of extravasation, a dislodgement or movement event, etc.

[0073] A vascular access system configured in accordance with embodiments of the present disclosure can be used in a variety of ways. As one example, a catheter of a vascular access device could initially be inserted into a patient’s vasculature. Then, an ultrasound patch of a monitoring assembly can be attached to the patient’s skin above the location of the catheter tip within the vasculature. The ultrasound patch could be separate from a securement dressing and in such cases, a securement dressing could be placed on the patient’s skin to secure the ultrasound patch and possibly to secure the vascular access device. Alternatively, the ultrasound patch could be part of a securement dressing and in such cases, the securement dressing can be placed on the patient’s skin to position the ultrasound patch and possibly to secure the vascular access device. One or more sensors of a sensor array may also be placed on the patient’s skin near the monitoring assembly. The sensor array could be separate, integrated into the ultrasound patch, integrated intothe securement dressing, or otherwise provided. In some cases, a vascular probe assembly could be coupled to the vascular access device. In other cases, a vascular probe assembly may be integrated into the vascular access device. In either case, the vascular probe assembly can be deployed into the patient’ s vasculature via the catheter or other instrument. Continuous monitoring may then be performed using any or all of the ultrasound probe, the sensor array, or sensors of the vascular probe assembly. Information generated from the continuous monitoring may be transferred to the cloud or other system for processing including by using algorithms and artificial intelligence. Various parameters, status updates, events, or other occurrences derived from the information can be communicated to clinicians, technicians, the patient, or other individual.

[0074] 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 vascular access system comprising: a vascular access device comprising a catheter; a monitoring assembly comprising an ultrasound probe that is configured to be positioned overtop the catheter when the catheter is inserted into a patient’s vasculature and a vascular probe assembly having one or more sensors that are configured to be inserted into the patient’s vasculature; and a base unit that is configured to receive images from the ultrasound probe and readings from the one or more sensors of the vascular probe assembly.

2. The vascular access system of claim 1, wherein the monitoring assembly comprises a sensor array having one or more sensors that are configured to be positioned on the patient’s skin, the base unit being configured to receive readings from the one or more sensors of the sensor array.

3. The vascular access system of claim 2, wherein one or more of the ultrasound probe, the vascular probe assembly, or the sensor array are configured to communicate with the base unit via a wired connection.

4. The vascular access system of claim 2, wherein one or more of the ultrasound probe, the vascular probe assembly, or the sensor array are configured to communicate with the base unit via a wireless connection.

5. The vascular access system of claim 1, further comprising: a securement dressing that is configured to secure the ultrasound probe overtop the catheter.

6. The vascular access system of claim 1, wherein the base unit is configured to generate display content from the images and the readings and transmit the display content to one or more monitoring devices.

7. The vascular access system of claim 6, wherein the base unit is configured to generate one or more parameters from the images and the readings and to include the one or more parameters in the display content.

8. The vascular access system of claim 7, wherein the parameters include catheter geometry or position information.

9. The vascular access system of claim 7, wherein the parameters include one or more of catheter movement or displacement, catheter kinking, dislodgment events, extravasation, infiltration detection, thrombus development, phlebitis, patency indicators, blood flow characteristics, fluid administration flow characteristics, procedural events, line draw tubing, probe or sensor position, SPO2, temperature, movement, falls, pH, blood gases, blood pressure, lactate,EKG, or pulse.

10. The vascular access system of claim 1, wherein the vascular probe assembly comprises a probe on which the one or more sensors are positioned.

11. The vascular access system of claim 10, wherein the vascular probe assembly comprises an electrical adapter.

12. The vascular access system of claim 11, wherein the vascular probe assembly includes a hub that is coupled to the electrical adapter.

13. The vascular access system of claim 12, wherein the hub includes a display.

14. The vascular access system of claim 11, wherein the vascular probe assembly includes a coupler by which the vascular probe assembly is coupled to the vascular access device and a housing that separates from the coupler to expose the electrical adapter.

15. A method for using a vascular access system comprising: inserting a catheter of a vascular access device into a patient’s vasculature; positioning an ultrasound probe of a monitoring assembly on the patient’s skin overtop a portion of the catheter that is inserted into the patient’s vasculature; positioning a probe of a vascular probe assembly in the patient’s vasculature via the vascular access device; and establishing a connection between the ultrasound probe and a base unit and between one or more sensors of the ultrasound probe assembly and the base unit to thereby enable the base unitto receive ultrasound images from the ultrasound probe where the ultrasound images capture the portion of the catheter that is inserted into the patient’s vasculature and to receive readings from the one or more sensors while the one or more sensors are within the patient’s vasculature.

16. The method of claim 15, wherein the connection is wired or wireless.

17. The method of claim 15, further comprising: placing a securement dressing overtop the ultrasound probe and a catheter adapter from which the catheter extends.

18. A method for monitoring a catheter comprising: receiving, from an ultrasound probe that is positioned overtop a catheter that is inserted into a patient’s vasculature, images that capture the catheter; receiving readings from one or more sensors of a vascular probe assembly that are inserted into the patient’s vasculature while the catheter is inserted into the patient’s vasculature; processing the images and the readings to determine one or more parameters; and generating display content that includes the one or more parameters.

19. The method of claim 18, wherein processing the images and the readings to determine one or more parameters comprises processing the images to determine geometry or position information of the catheter, line draw tubing, a probe or a sensor and processing the readings to determine pH, blood gases, blood pressure, temperature, lactate, EKG, or pulse.

20. The method of claim 19, further comprising: presenting at least some of the display content on a display integrated into the vascular probe assembly.

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