Vascular access systems and methods for continuous monitoring

Abstract

Vascular access systems and methods for continuous monitoring. A vascular access system may 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 may be positioned over a catheter inserted into a patient's vasculature. The monitoring assembly may include a sensor array for sensing a parameter from a skin surface of a patient. 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 the vascular probe assembly may be processed to generate parameters representing status, events, or other information about the catheter. Display content including images and parameters may be provided to a monitoring device.

Description

Background Technology

[0001] Catheters are commonly used in a variety of infusion therapies. For example, catheters can be used to deliver therapeutic agents or fluids into a patient. Catheters can also be used to draw blood from a patient. Various types of catheters are commonly used in the 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 needle-feed catheters. As the name suggests, needle-feed catheters are attached to a guide needle with a sharp distal tip.

[0002] The catheter and guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the catheter, with the bevel of the needle facing upwards and away from the patient's skin. The catheter and guide needle are typically inserted into the patient's vascular system through the skin at a shallow angle. To verify proper placement of the guide needle and / or catheter in the vessel, clinicians generally confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement has been confirmed, the catheter can remain in place for future blood draws or fluid infusions.

[0003] Although catheter placement performance (i.e., the time a catheter can remain safely in the vascular system) has improved in recent years, a number of complications can still occur during the expected indwelling time of vascular access devices. These complications may include displacement, extravasation, phlebitis, catheter-related infections, and loss of patency, among others.

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

[0005] The subject matter claimed herein is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0006] This disclosure generally relates to vascular access devices, systems, and methods. In particular, this disclosure relates to vascular access systems and methods for continuous monitoring. A vascular access system may include a vascular access device, a monitoring component, a fixation dressing, a basic unit, and one or more monitoring devices. The monitoring component may include an ultrasound probe that can be positioned over a catheter inserted into a patient's vascular system. The monitoring component may include a sensor array for sensing parameters from the patient's skin surface. The monitoring component may include a vascular probe assembly for sensing parameters from within the vascular system. Images from the ultrasound probe and / or parameters sensed by the sensor array and / or the vascular probe assembly can be processed to generate parameters representing status, events, or other information about the catheter. A display including images and parameters can be provided to the monitoring device.

[0007] In some embodiments, the vascular access system may include a vascular access device with a catheter, a monitoring component, and a basic unit. The monitoring component may include an ultrasound probe configured to be positioned over the catheter when it is inserted into the patient's vascular system. The monitoring component may also include a vascular probe assembly with one or more sensors configured to be inserted into the patient's vascular system. The basic unit may be configured to receive images from the ultrasound probe and readings from one or more sensors of the vascular probe assembly.

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

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

[0010] In some embodiments, one or more of the ultrasound probe, vascular probe assembly, or 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 fixation dressing configured to fix an ultrasound probe to a catheter.

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

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

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

[0015] In some embodiments, parameters may include one or more of the following: catheter movement or displacement, catheter kinking, out-of-situ event, extravasation, infiltration detection, thrombosis, phlebitis, patency indicator, blood flow characteristics, fluid application flow characteristics, programmed events, tubing aspiration fitting, probe or sensor position, SpO2, temperature, movement, fall, pH, blood gas, blood pressure, lactate, EKG, or pulse.

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

[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 connected to an electrical adapter.

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

[0020] In some embodiments, the vascular probe assembly may include a connector and a housing, the vascular probe assembly being coupled to a vascular access device via the connector, and the housing being detached from the connector to expose an electrical adapter.

[0021] In some embodiments, a method of using a vascular access system may include inserting a catheter of a vascular access device into a patient's vascular system; positioning an ultrasound probe of a monitoring component on the patient's skin, over a portion of the catheter inserted into the patient's vascular system; positioning a probe of a vascular probe assembly within the patient's vascular system via the vascular access device; and establishing connections between the ultrasound probe and a base unit, and between one or more sensors of the ultrasound probe assembly and the base unit, thereby enabling the base unit to receive ultrasound images from the ultrasound probe, wherein the ultrasound images capture the portion of the catheter inserted into the patient's vascular system, and readings are received from one or more sensors when the sensors are within the patient's vascular system.

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

[0023] In some embodiments, the method may further include placing a fixation dressing over the ultrasound probe and the catheter adapter, with the catheter extending from the catheter adapter.

[0024] In some embodiments, a method for monitoring a catheter may include receiving an image from an ultrasound probe positioned over a catheter inserted into a patient's vascular system, the image capturing the catheter; receiving readings from one or more sensors of a vascular probe assembly inserted into the patient's vascular system when the catheter is inserted; processing the image and readings to determine one or more parameters; and generating display content including one or more parameters.

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

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

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

[0028] It should be understood that the foregoing general description and the following detailed description are merely exemplary and explanatory, and not intended to limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that these embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention unless so stated. Therefore, the following detailed description should not be construed as limiting. Attached Figure Description

[0029] Exemplary embodiments will be described and explained with additional specificity and detail using the accompanying drawings, in which:

[0030] Figure 1 illustrates a prior art piezoelectric transducer array for performing ultrasound;

[0031] Figure 2A Examples of vascular access systems configured according to one or more embodiments are provided;

[0032] Figure 2B Another example of a vascular access system configured according to one or more embodiments is provided;

[0033] Figure 2C Another example of a vascular access system configured according to one or more embodiments is provided;

[0034] Figure 3A Another example of a vascular access system configured according to one or more embodiments is provided;

[0035] Figure 3B Another example of a vascular access system configured according to one or more embodiments is provided;

[0036] Figure 3C Another example of a vascular access system configured according to one or more embodiments is provided;

[0037] Figure 4A and Figure 4B Examples of vascular probe assemblies that can form part of a vascular access system according to one or more embodiments are provided;

[0038] Figure 5A and Figure 5B Another example of a vascular probe assembly that can form part of a vascular access system according to one or more embodiments is provided;

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

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

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

[0042] Figure 7 Examples can be generated by a vascular access system configured according to one or more embodiments;

[0043] Figure 8 Examples of electronic components that may be included in a basic unit or monitoring device of a vascular access system in one or more embodiments are provided. Detailed Implementation

[0044] Now for reference Figure 2A and Figure 2BIn some embodiments, the vascular access system 50 may include a vascular access device 100, a monitoring assembly 200, a fixation dressing 300, and one or more monitoring devices 400. The vascular access device 100 may include a catheter adapter 101, a catheter 102 extending distally from the catheter adapter 101, a fixation platform 103 (e.g., a wing extending laterally from the catheter adapter 101), a needle access port 104, a proximal patient access port 105, an extension fitting 106, and an access port 109. A guide needle (not shown) can be inserted through the needle access port 104 through the catheter adapter 101 and the catheter 102. The proximal patient access port 105 can be connected to a side port of the catheter adapter 101. The extension fitting 106 has a clamp 107, and a Luer adapter 108 is connected to the extension fitting 106. The access port 109 is coupled to the Luer adapter 108. This is merely one example of various different configurations of the vascular access device that can be used in a vascular access system configured according to embodiments of the present disclosure.

[0045] The monitoring component configured according to embodiments of this disclosure may include any or all of an ultrasound probe, a sensor array, or a vascular probe assembly. The monitoring component can be used for continuous monitoring of the vascular access device 100. In some embodiments, such continuous monitoring may cover before, during, and after catheter insertion. In some embodiments, images, readings, and / or parameters generated by the monitoring component may be presented to a clinician, processed to automatically detect events, states, or other conditions, stored for subsequent analysis, or otherwise used to enhance continuity of care.

[0046] exist Figure 2A The monitoring component 200 may include: an ultrasound probe 201; a fastening mechanism 202 for fastening the ultrasound probe 201 to the skin and / or catheter 102; an electrical adapter 203 through which a cable 204 is connected to the ultrasound probe 201; a base unit 205; a sensor array including one or more sensors 207 for sensing parameters from the patient's skin surface; one or more status indicators 209; and a vascular probe assembly 210 through which various parameters can be sensed from within the vascular system. Figure 2A This illustrates an embodiment where the basic unit 205 has a wired connection (cable 204) to the ultrasound probe 201 and sensor 207, and a wireless connection to the vascular probe assembly 210. Figure 2B In this configuration, the monitoring component 200 includes a wireless adapter 206 replacing the cable 204, enabling the basic unit 205 to have wireless connectivity with the ultrasound probe 201, sensor 207, and vascular probe assembly 210. Figure 2CIn this embodiment, monitoring component 200 includes a cable 208 connecting vascular probe component 210 to electrical adapter 203, and thus indicates an embodiment in which vascular probe component 210 has a wired connection. Therefore, in some embodiments, any arrangement of wireless and / or wired connections can be used.

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

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

[0049] The fixation dressing 300 may be sized and shaped to cover the ultrasound probe 201, one or more sensors 207, and catheter adapter 101 and fix them against the patient's skin. For example, in some embodiments, the fixation dressing 300 may completely cover the catheter adapter 101 and may include an opening through which an extension tube 106 extends. The underside of the fixation dressing 300 may be adhesive to prevent movement of the fixation dressing 300 after it has been placed on the skin. In some embodiments, an opening 301 may be formed in the fixation dressing 300 to correspond to the insertion site of the catheter 102 and may allow for the placement of an adhesive 302 for sealing the insertion site.

[0050] In some embodiments, the ultrasound probe 201 may be integrated into the fixation dressing 300. In other embodiments, the ultrasound probe 201 may be separate from the fixation dressing 300. In such embodiments, the ultrasound probe 201 may be placed over the catheter 102, and then the fixation dressing 300 may be placed over the ultrasound probe 201, one or more sensors 207, and the catheter adapter 101. In any case, the ultrasound probe 201 may be positioned on the patient's skin such that when the catheter 102 is inserted into the patient's vascular system, the ultrasound probe 201 is located over the distal end of the catheter 102. One or more sensors 207 may also be placed on or near the catheter 102.

[0051] In some embodiments, the vascular probe assembly 210 may be integrated into the vascular access device 100. In some embodiments, the vascular probe assembly 210 may be configured to be coupled to the vascular access device 100 via a proximal patient access port 105. The vascular probe assembly 210 may include a probe 213 and one or more sensors 213a positioned on the distal end of the probe 213. The vascular probe assembly 210 may also include an electrical adapter 211 through which the sensors 213a may be electrically coupled to the monitoring assembly 200.

[0052] The vascular access probe configured according to embodiments of this disclosure can have various configurations. Figure 4A and Figure 4BExamples of how the vascular probe assembly 210 can be configured in some embodiments are provided. As shown, the vascular probe assembly 210 may include an electrical adapter 211 at a proximal end and a probe 213 extending distally from the electrical adapter 211. One or more sensors 213a may be positioned at the distal end of the probe 213 such that they will be positioned within the patient's vascular system during use. The sensors 213a may be electrically connected to the electrical adapter 211 (e.g., via one or more wires, traces, or other electrical connection media). The vascular probe assembly 210 may include a housing 214 and a connector 212 at the distal end of the housing 214. The connector 212 may be configured to connect to a proximal patient access port 105. A slider 215 may be fixed to the housing 214 and configured to move the probe 213 from an initial proximal position (e.g., as shown in the image). Figure 4A (As shown) Slide to the far-side deployment location (e.g., as shown) Figure 4B (as shown in the diagram). In some embodiments, housing 214 may be configured to separate from connector 212 to expose electrical adapter 211. In some embodiments, housing 214 may be configured to separate only after slider 215 has slid distally to deploy probe 213.

[0053] Figure 5A and Figure 5B Another example of how the vascular probe assembly 210 can be configured is provided in some embodiments. In these embodiments, the vascular probe assembly 210 also includes an extension 216 between the probe 213 and the electrical adapter 211. One or more wires, traces, or other electrical connection media may extend through the extension 216 to allow one or more sensors 213a to be powered and / or controlled via the electrical adapter 211. Figure 5B As indicated in the text, the extension 216 allows the electrical adapter 211 to be positioned away from the patient access port 105.

[0054] In embodiments where the monitoring component 200 includes the vascular probe assembly 210, the monitoring component 200 may further include a hub 217, which can be connected to an electrical adapter 211. The hub 217 may be configured to provide power to (one or more) sensors 213a and / or enable communication with (one or more) sensors 213a. For example, in Figure 2A and Figure 2B In this configuration, hub 217 includes a wireless interface enabling communication between sensor 213a and base unit 205 (or possibly one or more monitoring devices 400). In some embodiments, hub 217 may include one or more batteries for powering sensor 213a. As another example, in Figure 2CIn the hub 217, a wired interface is included through which (one or more) sensors 213a are connected to the power adapter 203 (or possibly directly to the cable 204). In some embodiments, communication and / or power may be delivered via cable 208. Figure 5B In the middle, hub 217 provides a connection point for cable 204 and indicates that the monitoring component 200 includes only an embodiment of the vascular probe component 210.

[0055] Figures 3A to 3C Additional examples of how the vascular access system 50 can be configured in some embodiments are provided. Figure 3A In the monitoring component 200, there is a hub 217 of an electrical adapter 211 directly connected to the vascular probe assembly 210, and a cable 208 connected to the electrical adapter 203. Furthermore, in Figure 3A In the fixed dressing 300, the opening 301 extends beyond the insertion site and surrounds the ultrasonic patch 201.

[0056] In some embodiments, such as Figure 3A The hub 217 shown can be configured to interact with the base unit 205, while in other embodiments, the hub 217 can serve as the base unit 205. The hub 217 can power and / or communicate with the ultrasonic probe 201 via cable 208.

[0057] like Figure 3A The hub 217 also includes an integrated display 218 through which one or more parameters (e.g., heart rate, body temperature, blood oxygen level) can be displayed. In some embodiments, such parameters can be derived from readings obtained by sensor 213a. In embodiments where the monitoring component 200 includes a sensor array, such parameters can be derived from readings obtained by sensor 207. In some embodiments, the display 218 can also, or alternatively, be configured to display images and / or parameters generated by ultrasound probe 201. Thus, the display 218 can be used to present any information or content generated by the monitoring component 200 at the point of care. The hub 217 can also communicate directly or via the base unit 205 with (one or more) monitoring devices 400.

[0058] exist Figure 3B In China, the vascular access system 50 is similar to Figure 3A The vascular access system is shown. However, hub 217 does not include display 218 and forms a wired interface to electrical adapter 203 via cable 208. Electrical adapter 203 also forms a wired interface to base unit 205 via cable 204. Figure 3C In China, the vascular access system 50 is similar to Figure 3B The vascular access system is shown. However, cable 204 connects between hub 217 and basic unit 205. Figures 3A to 3C In this embodiment, monitoring component 200 does not include a sensor array. However, a sensor array may be included in any embodiment illustrated in these figures.

[0059] The monitoring device 400 may represent any device having a display on which images generated by the ultrasound probe 201 can be displayed and / or on which information obtained from such images and / or readings from the sensors 207 and / or the sensors 213a can be displayed. As an example, the monitoring device 400 may include a smartphone, tablet, laptop, desktop computer, thin client, television, dedicated display device, infusion pump, patient vital signs monitor, arterial monitor, ultrasound system visual display, etc. In some embodiments, the monitoring device 400 may be used as a basic unit 205. The monitoring device 400 may also be configured to interact with one or more separate computing systems, such as systems for storing patient data.

[0060] In embodiments including wireless adapter 206, wireless adapter 206 may be configured to transmit images generated by ultrasound probe 201 and / or readings from (one or more) sensors 207 and / or (one or more) sensors 213a to base unit 205 or possibly to (one or more) monitoring devices 400. Wireless adapter 206 may also include a battery for powering ultrasound probe 201, (one or more) sensors 207 and / or vasculature probe assembly 210. In some embodiments, wireless adapter 206 may be integrated into electrical adapter 203, while in other embodiments, wireless adapter 206 may be selectively coupled to electrical adapter 203.

[0061] Figures 2A to 3C Examples are provided in which the vascular access system 50 includes a peripheral intravenous catheter. However, the vascular access system configured according to embodiments of the present disclosure can be used with central venous catheters, peripherally inserted central catheters, midline catheters, arterial catheters, ports, venous punctures, subcutaneous access devices or other indwelling catheters, probes, sensors or instruments.

[0062] Figure 6AThis is a partial cross-sectional view of the vascular access system 50 when used on a patient. As shown, when the catheter 102 is inserted into the patient's vascular system 600, the ultrasound probe 201 can be positioned on the patient's skin above the distal end 102a of the catheter 102 via a fixation mechanism 202. A fixation dressing 300, which may include an opening 301, can be positioned over the catheter adapter 101 and the ultrasound probe 201 to maintain this positioning of the ultrasound probe 201 above the distal end 102a. In this position, the ultrasound probe 201 can continuously, periodically, on demand, etc., generate ultrasound images of portions of the vascular system 600 (including surrounding tissues) in which the catheter 102 extends. For example, Figure 6B It is an image of a transverse view of the vascular system 600, catheter 102, and distal end 102a, and Figure 6C It is an image of a cross-sectional view of the vascular system 600 and the catheter 102.

[0063] Figure 7 An example is provided of how to integrate an image generated by ultrasound probe 201 along with various information derived from the image into a display. As indicated, this display can be generated and / or presented on the basic unit 205, any number of monitoring devices 400, and / or display 218. The display may include one or more views of catheter 102 within the vascular system 600, such as… Figure 6B landscape view and Figure 6C A cross-sectional view. A lateral view allows clinicians to see how catheter 102 extends into the vascular system 600, and thus facilitates rapid determination of whether catheter 102 is adequately inserted, whether the distal end 102a is correctly positioned, and whether there are any obstructions or other conditions detectable by ultrasound. A cross-sectional view allows clinicians to see how specific portions of catheter 102 are positioned within the vascular system 600, and thus facilitates rapid determination of whether catheter 102 may be excessively restricting blood flow through the vascular system 600 or any other conditions detectable by ultrasound. In some embodiments, the user may be able to adjust the position of the view generated by the ultrasound probe 201. For example, the user may be able to move the cross-sectional view along the length of catheter 102 to determine whether excessive obstruction exists at any point along the length of catheter 102.

[0064] Figure 7 The illustration also shows that the display may include various information that can be generated from an image produced by the ultrasound probe 201 or derived from input. For example, an indicator 601a showing the specifications of the catheter 102 and an indicator 601b showing the length of the catheter 102 are displayed. Indicators 601a and 601b can be obtained via user input or calculated from an image produced by the ultrasound probe 201.

[0065] The display also includes indicators 602a, 602b, and 602c for different parameters. In some embodiments, these parameters may be selectable. For example, in Figure 7 In this configuration, indicator 602a provides information about the time of the last flushing of catheter 102. This last flushing information can be calculated using images generated by ultrasonic probe 201. For example, Doppler technology can be applied to the image data to detect when fluid flows out through the distal end 102a, and in response to such detection, basic unit 205 (or monitoring device 400) can store an indication that flushing has occurred at this time. Figure 7 In the present invention, indicators 602b and 602c are not yet selected. However, these indicators can be selected to display information about any of a number of different conditions, events, states, etc., as described below.

[0066] The display also includes indicators 603a and 603b, which provide information about the portion of catheter 102 within the vascular system 600. Indicator 603a defines the ratio of the catheter to the vein (i.e., the ratio of the diameter of the catheter to the diameter of the vein at a given location). Indicator 603b defines the insertion length of catheter 102 (i.e., the length of catheter 102 within the vascular system 501). The display additionally includes indicator 604 defining the patency status of catheter 102 (i.e., whether catheter 102 can be safely retained within the vascular system 600). The basic unit 205 (or monitoring device 400) can use images provided by the ultrasound probe 201 to calculate the patency status (e.g., to detect the degree to which catheter 102 and / or the vascular system 600 surrounding catheter 102 may be obstructed).

[0067] As suggested above, the vascular access system 50 can be configured to monitor and / or display information related to the status of the catheter 102, the vascular system 600, or surrounding tissues, as well as various associated physiological or procedural parameters, by utilizing images provided by the ultrasound probe 201. This information includes catheter geometry information (e.g., catheter-to-vein ratio, catheter insertion length, flow restriction around the catheter), catheter position information (axial position of the catheter within the vein, position or angle of the distal end of the catheter relative to the vein wall, valve, branch, or other physiological features), catheter movement or displacement, catheter kinking, out-of-situ events, extravasation, extravasation detection (e.g., by monitoring tissue surrounding the vascular system 600), thrombosis, phlebitis (visual or associated cumulative motion), patency indicators, blood flow characteristics (e.g., by using Doppler to detect the velocity and / or volume of blood flowing into catheter 102), fluid application flow characteristics (e.g., by using Doppler to detect the velocity, volume, direction, and / or duration of fluid flow), programmed events (e.g., flushing, aspiration, fluid application), and / or the location of tubing aspiration fittings, probes, or sensors in the vein or relative to the distal end of the catheter or physiological features (e.g., thrombus, valve, wall, branch, etc.).

[0068] Additionally, readings from (one or more) sensors 207 and / or (one or more) sensors 213a may also be used, or alternatively, to display information associated with the state of catheter 102, vascular system 600, or surrounding tissues, as well as various associated physiological or procedural parameters. For example, (one or more) sensors 207 may be used to monitor infiltration, SpO2, temperature, movement, falls, etc., and (one or more) sensors 213a may be used to monitor pH, blood gases, blood pressure, lactate, temperature, EKG, pulse, or other available intravascular parameters. (One or more) status indicators 209 may be used to indicate the state of catheter 102 based on any one or more parameters derived from readings / information generated by ultrasound probe 201, (one or more) sensors 207, and / or (one or more) sensors 213a.

[0069] The vascular access system 50 can provide a display of indicators including any of the information described above, and can provide corresponding alarms. For example, the display 218, the basic unit 205, or the monitoring device 400 can be configured to output visual, auditory, tactile, or digital alarms when a condition or event is detected from the ultrasound image. In some embodiments, the ultrasound probe 201, electrical adapter 203 or 211, cable 204 or 208, wireless adapter 206, hub 217, etc., may include one or more alarm mechanisms (e.g., LEDs, speakers, tactile units, etc.) to provide alarms.

[0070] Figure 8 Examples are provided of how the basic unit 205 (or possibly the monitoring device 400) can be configured to generate display content from ultrasound images. This display content may include any information, indicators, statuses, events, alarms, etc. (collectively, “parameters”) described above. Figure 7 This is an example of the content being displayed.

[0071] Basic unit 205 can be configured to continuously, periodically, or on demand receive ultrasound images from ultrasound probe 201. Basic unit 205 may include image processor 205a, which is configured to process the ultrasound images to generate processed image data. This processed image data can be input to artificial intelligence engine 205b, which can be configured to detect and / or generate parameters from the processed image data. The parameters can be provided along with the ultrasound images to display module 205c, which can generate display content including the images and parameters.

[0072] In some embodiments, the image processor 205a may be configured to determine various state information from images or image sequences, such as catheter geometry or location information, or the presence of thrombi, kinks, or other obstructions. In some embodiments, the artificial intelligence engine 205b may be trained to detect when parameters are present in the ultrasound image stream. For example, the artificial intelligence engine 205b may detect when the ultrasound image sequence indicates an irrigation event, aspiration event, extravasation, departure from situ, or movement event, etc.

[0073] The vascular access system configured according to embodiments of this disclosure can be used in a variety of ways. As an example, a catheter of the vascular access device can be initially inserted into a patient's vascular system. An ultrasound patch of the monitoring component can then be attached to the patient's skin above the location of the catheter tip within the vascular system. The ultrasound patch can be separate from a fixation dressing, in which case the fixation dressing can be placed on the patient's skin to fix the ultrasound patch and possibly the vascular access device. Alternatively, the ultrasound patch can be part of a fixation dressing, in which case the fixation dressing can be placed on the patient's skin to position the ultrasound patch and possibly fix the vascular access device. One or more sensors of a sensor array can also be placed on the patient's skin near the monitoring component. The sensor array can be separate, integrated into the ultrasound patch, integrated into the fixation dressing, or otherwise provided. In some cases, a vascular probe assembly can be coupled to the vascular access device. In other cases, the vascular probe assembly can be integrated into the vascular access device. In either case, the vascular probe assembly can be deployed into the patient's vascular system via a catheter or other device. Continuous monitoring can then be performed using any or all of the sensors in an ultrasound probe, sensor array, or vascular probe assembly. Information generated from continuous monitoring can be transmitted to the cloud or other systems for processing, including through the use of algorithms and artificial intelligence. Various parameters, status updates, events, or other information derived from this data can be communicated to clinicians, technicians, patients, or other individuals.

[0074] All examples and conditional language listed herein are for illustrative purposes, to aid the reader in understanding the invention and the concepts contributed by the inventors to the field, and should be interpreted as not being limited to these specifically cited examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the invention.

Claims

1. A vascular access system, comprising: a vascular access device comprising a catheter; a monitoring assembly comprising an ultrasound probe configured to be positioned over the catheter when the catheter is inserted into a patient's vasculature, and a vascular probe assembly having one or more sensors configured to be inserted into the patient's vasculature; and a base unit 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 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 configured to secure the ultrasound probe over 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 to 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 comprise catheter geometry or position information.

9. The vascular access system of claim 7, wherein, the parameters comprise one or more of catheter motion or displacement, catheter kinking, ex-situ events, extravasation, infiltration detection, thrombus formation, phlebitis, patency indicators, blood flow characteristics, fluid administration flow characteristics, procedural events, line suction tubing, probe or sensor position, SPO2, temperature, motion, falls, pH, blood gas, blood pressure, lactate, EKG, or pulse.

10. The vascular access system of claim 1, wherein, the vascular probe assembly comprises a probe over 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 comprises a hub coupled to the electrical adapter.

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

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

15. A method of 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 over a portion of the catheter that is inserted into the patient's vasculature on the patient's skin; 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 the base unit and between one or more sensors of the ultrasound probe assembly and the base unit, thereby enabling the base unit to receive ultrasound images from the ultrasound probe, wherein, The ultrasound image captures a portion of the catheter inserted into the patient's vasculature and receives 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 over the ultrasound probe and catheter adapter from which the catheter extends.

18. A method for monitoring a catheter, comprising: receiving an image from an ultrasound probe positioned over a catheter inserted into a patient's vasculature, the image capturing the catheter; receiving readings from one or more sensors of a vascular probe assembly inserted into the patient's vasculature while the catheter is inserted into the patient's vasculature; processing the image and the readings to determine one or more parameters; and generating display content comprising the one or more parameters.

19. The method of claim 18, wherein, Processing the image and the readings to determine one or more parameters comprises processing the image to determine geometry or position information of the catheter, tubing, aspiration tubing, probe, or sensors and processing the readings to determine pH, blood gas, 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.

Images