Vascular access system and method for continuous ultrasound monitoring and integrated sensor arrays

Abstract

A vascular access system and method for ultrasound monitoring and an integrated sensor array are provided. The vascular access system may include a vascular access device, an ultrasound assembly, a fixation dressing, a base unit, and one or more monitoring devices. The ultrasound assembly may include an ultrasound probe that can be positioned on a catheter when inserted into the patient's vascular system and may be configured to allow integration of one or more sensors. Images from the ultrasound probe and readings from one or more sensors can be processed to generate parameters representing the state, events, or other information about the catheter. Display content, including images and parameters, may be provided to the monitoring device.

Description

Technical Field

[0001] The present disclosure relates to a vascular access system and method for continuous ultrasonic monitoring and an integrated sensor array.

Background Art

[0002] Catheters are widely used in various infusion therapies. For example, a catheter can be used to inject a therapeutic agent or fluid into a patient. Also, a catheter can be used to collect blood from a patient. In a medical setting, various catheters such as, for example, a peripherally inserted central catheter, a midline catheter, a central venous catheter, a dialysis catheter, and an arterial catheter are widely used. One common catheter device is an over-the-needle type catheter. As the name implies, an over-the-needle type catheter is attached to an introducer needle having a sharp tip.

[0003] The catheter and the introducer needle can be assembled such that the distal end of the introducer needle protrudes beyond the distal end of the catheter and the bevel of the needle faces upward away from the patient's skin. The catheter and the introducer needle are typically inserted through the skin into the patient's vascular system at a shallow angle. To confirm that the introducer needle and / or the catheter is properly placed within the blood vessel, a clinician typically checks for a "flashback" of blood in the flashback chamber of the catheter assembly. Once the placement of the needle is confirmed, the catheter can be left in place for future blood sampling or infusion.

[0004] In recent years, although catheter retention performance (i.e., the time the catheter can be safely retained within the vascular system) has improved, there are still numerous complications that can occur during the intended retention time of a vascular access device. These complications can include catheter dislodgment, infiltration, extravasation, phlebitis, catheter-related infections, loss of patency, and the like.

[0005] Figure 1 shows a conventional piezoelectric transducer array 10 (or ultrasound probe 10) for ultrasound diagnostics. Because the ultrasound probe 10 can be attached to the skin, it can be used for imaging diagnostics of deep tissues.

[0006] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or embodiments that operate only in the environment described above. Rather, this background art is provided solely to illustrate an example of the technical field in which some of the implementations described herein may be put into practice. [Overview of the Initiative]

[0007] This disclosure generally relates to vascular access devices, systems, and methods. In particular, this disclosure relates to vascular access systems and methods for continuous ultrasound monitoring and integrated sensor arrays. The vascular access system may include a vascular access device, an ultrasound assembly, a fixation dressing, a base unit, and one or more monitoring devices. The ultrasound assembly may include an ultrasound probe that can be positioned on a catheter when inserted into the patient's vascular system and may be configured to allow integration of one or more sensors. Images from the ultrasound probe and readings from one or more sensors can be processed to generate parameters representing the state, events, or other information about the catheter. Display content, including images and parameters, may be provided to a monitoring device.

[0008] In some embodiments, the vascular access system may include a vascular access device including a catheter, an ultrasound assembly including an ultrasound probe and a sensor array, wherein the ultrasound probe is configured to be positioned on the catheter when the catheter is inserted into the patient's vascular system, and a base unit configured to receive images from the ultrasound probe.

[0009] In some embodiments, the ultrasonic assembly may include cables connecting the ultrasonic probe and sensor array to a base unit.

[0010] In some embodiments, the ultrasonic assembly may include a wireless adapter that wirelessly connects the ultrasonic probe and sensor array to the base unit.

[0011] In some embodiments, the vascular access system may include a fixation dressing configured to secure an ultrasound probe and sensor array to a catheter.

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

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

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

[0015] In some embodiments, the parameters may include one or more of the following: catheter movement or motion, catheter twisting, detachment events, extravasation, infiltration detection, thrombus formation, phlebitis, patency indicators, blood flow characteristics, fluid administration flow rate characteristics, treatment events, or line draw tube, probe or sensor position.

[0016] In some embodiments, a method for using a vascular access system includes inserting a catheter of the vascular access device into the patient's vascular system; placing an ultrasound assembly, including an ultrasound probe and a sensor array, on the patient's skin over a portion of the catheter inserted into the patient's vascular system; and establishing a connection between the ultrasound assembly and a base unit, so that the base unit can receive ultrasound images from the ultrasound probe and readings from the sensor array, the ultrasound images capturing a portion of the catheter inserted into the patient's vascular system.

[0017] In some embodiments, the connection is wireless or wired.

[0018] In some embodiments, the method may also include placing a fixation dressing on a catheter adapter from which an ultrasound probe, sensor array, and catheter extends.

[0019] In some embodiments, a method for monitoring a catheter may include receiving an image capturing the catheter from an ultrasound probe positioned over the catheter as it is inserted into the patient's vascular system, receiving readings from a sensor array integrated with the ultrasound probe, processing the image and readings to determine one or more parameters, and generating display content including one or more parameters.

[0020] In some embodiments, processing images and readings to determine one or more parameters may include determining shape or position information, or a catheter, line draw tube, probe, or sensor.

[0021] In some embodiments, processing images and readings to determine one or more parameters may include detecting catheter movement or motion.

[0022] In some embodiments, processing the image and the readings to determine one or more parameters may include detecting extravasation or infiltration.

[0023] In some embodiments, processing the image and the readings to determine one or more parameters may include detecting a thrombus or phlebitis.

[0024] In some embodiments, processing the image and the readings to determine one or more parameters may include determining blood or fluid administration flow characteristics.

[0025] In some embodiments, processing the image and the readings to determine one or more parameters may include detecting a treatment event.

[0026] In some embodiments, the display content may also include at least some of the images.

[0027] In some embodiments, one or more parameters may be determined using artificial intelligence.

[0028] It should be understood that both the foregoing general description and the following detailed description are exemplary 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 instruments shown in the drawings. It should also be understood that the embodiments can be combined, other embodiments can be utilized, and structural changes not recited in the claims can be made without departing from the scope of the various embodiments of the invention. Accordingly, the following detailed description should not be taken in a limiting sense.

Brief Description of the Drawings

[0029] Exemplary embodiments are described and detailed further and more specifically through the use of the accompanying drawings.

[0030] [Figure 1] FIG. 1 is a diagram showing a conventional piezoelectric transducer array for performing ultrasonic diagnosis. [Figure 2A] FIG. 2A is a diagram providing an example of a vascular access system configured according to one or more embodiments. [Figure 2B] FIG. 2B is a diagram providing another example of a vascular access system configured according to one or more embodiments. [Figure 2C] FIG. 2C is a diagram providing another example of a vascular access system configured according to one or more embodiments. [Figure 3A] FIG. 3A is a partial cross-sectional view of a vascular access device configured according to one or more embodiments when disposed on the skin. [Figure 3B] FIG. 3B is a cross-sectional view of a vein into which a catheter that may be generated by a vascular access device configured according to one or more embodiments is inserted. [Figure 3C] FIG. 3C is a cross-sectional view of a vein into which a catheter that may be generated by a vascular access device configured according to one or more embodiments is inserted. [Figure 4] FIG. 4 is a diagram showing an exemplary display that may be generated by a vascular access system configured according to one or more embodiments. [Figure 5] FIG. 5 is a diagram providing an example of electronic components that may be included in a base unit or a monitoring device of a vascular access system according to one or more embodiments.

DETAILED DESCRIPTION OF THE INVENTION

[0031] Referring to Figure 2A, in some embodiments, the vascular access system 50 may include a vascular access device 100, an ultrasound 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., wings extending outward from the catheter adapter 101), a needle access port 104 into which an introduction needle can be inserted through the catheter adapter 101 and catheter 102, a patient-proximal access port 105 which can be connected to a side port of the catheter adapter 101, an extension tube 106 having a clamp 107 to which a Luer adapter 108 is connected, and an access port 109 connected to the Luer adapter 108. This is just one example of various different configurations of the vascular access device that may be used in a vascular access system configured according to embodiments of the present disclosure.

[0032] The ultrasound assembly 200 may include an ultrasound probe 201, a fixation mechanism 202 for securing the ultrasound probe 201 to the skin and / or catheter 102, an electrical adapter 203 for connecting a cable 204 to the ultrasound probe 201, a sensor array including one or more sensors 207, and a base unit 205 to which the cable 204 can be connected to enable communication between the ultrasound probe 201 and each sensor 207 in the sensor array. In some embodiments, the fixation mechanism 202 may be an adhesive film on the back of the ultrasound probe 201 which can be used to directly adhere the ultrasound probe 201 to the patient's skin over 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 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 that can selectively connect sensors 207 to form a sensor array. In some embodiments, one or more sensors 207 may be integrated into the electrical adapter 203.

[0033] The base unit 205 may be any device including circuitry for communicating with the ultrasound probe 201 and each sensor 207 of the sensor array. In some embodiments, the base unit 205 may supply power to the ultrasound probe 201 and each sensor 207. In some embodiments, the base unit 205 may directly process images received from the ultrasound probe 201 and readings from the sensors 207, while in other embodiments, the base unit 205 may receive images from the ultrasound probe 201 and readings from the sensors and send the images and / or readings to another device for processing. In some embodiments, the base unit 205 may include a user input element that allows a user (e.g., a clinician and / or patient) to control the ultrasound probe 201 and / or sensors 207. In some embodiments, the base unit 205 may be connected to one or more other devices so that users of one or more other devices can control the ultrasound probe 201 and / or sensors 207.

[0034] The fixation dressing 300 may be sized and shaped to cover and fix the ultrasound probe 201, sensor 207, and catheter adapter 101 to the patient's skin. For example, in some embodiments, the fixation dressing 300 may completely cover the catheter adapter 101 and include an opening through which the extension tube 106 passes. The back surface of the fixation dressing 300 may be adhesive to prevent the fixation dressing 300 from moving once attached to the skin. In some embodiments, a transparent window 301 may be formed in the fixation dressing 300 to facilitate visibility of the catheter 102 and ultrasound probe 201.

[0035] In some embodiments, the ultrasound probe 201 may be integrated with the fixation dressing 300. In other embodiments, the ultrasound probe 201 may be detachable from the fixation dressing 300. In such embodiments, the ultrasound probe 201 may be positioned on the catheter 102, and the fixation dressing 300 may then be positioned on the ultrasound probe 201, the sensor 207, and the catheter adapter 101. In any case, the ultrasound probe 201 may be positioned on the patient's skin so as to be located above the distal end of the catheter 102 when the catheter 102 is inserted into the patient's vascular system. The sensor 207 may also be positioned above or near the distal end of the catheter 102.

[0036] The monitoring device 400 can represent any device having a display capable of displaying images generated by the ultrasound probe 201 and / or information obtained from such images and / or readings from the sensor 207. Examples of the monitoring device 400 include smartphones, tablets, laptops, desktops, thin clients, televisions, dedicated display devices, infusion pumps, patient vital sign monitors, arterial monitors, and visual displays for ultrasound systems. In some embodiments, the monitoring device 400 may function as a base unit 205. The monitoring device 400 may also be configured to interface with one or more separate computing systems, such as a system for storing patient data.

[0037] Figure 2B provides another configuration example of a vascular access system 50 in which a wireless adapter 206 is used instead of a cable 204. The wireless adapter 206 may be configured to transmit images generated by the ultrasound probe 201 and readings from the sensor 207 to the base unit 205 or, optionally, a monitoring device 400. The wireless adapter 206 may also include a battery to power the ultrasound probe 201 and the sensor 207. In some embodiments, the wireless adapter 206 may be integrated with the electrical adapter 203, while in other embodiments, the wireless adapter 206 may be selectively coupled to the electrical adapter 203.

[0038] Figure 2C is the same as Figure 2B, but includes an additional sensor 207 connected to the opposite side of the electrical connector 203. The electrical connector 203 may be shaped and / or sized to accommodate any appropriate number of sensors 207 as part of a sensor array integrated with the ultrasonic probe 201.

[0039] Figures 2A to 2C provide an example in which the vascular access system 50 includes a peripheral venous catheter. However, a vascular access system configured according to embodiments of this disclosure can be used with a central venous catheter, a peripherally inserted central venous catheter, a midline catheter, an arterial catheter, a port, a venous puncture, a subcutaneous access device, or other indwelling tubes, probes, sensors, or instruments.

[0040] Figure 3A is a partial cross-sectional view of a vascular access system 50 used on a patient. As shown, when the catheter 102 is inserted into the patient's vascular system 501, 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 sensor 207, not shown in Figure 3A, can also be positioned above the distal end 102a. By placing a fixation dressing 300 over the catheter adapter 101, the ultrasound probe 201, and the sensor 207, the ultrasound probe 201 and sensor 207 can be maintained in a position above the distal end 102a. In this position, the ultrasound probe 201 can generate ultrasound images of the portion of the vascular system 501 into which the catheter 102 extends and the surrounding tissue, continuously, periodically, on demand, etc. For example, Figure 3B is an image capturing a cross-sectional view of the vascular system 501, catheter 102, and distal end 102a, and Figure 3C is an image capturing a cross-sectional view of the vascular system 501 and catheter 102. Similarly, the sensor 207 can generate readings continuously, periodically, on demand, etc., for the portion of the vascular system 501 into which catheter 102 extends and the surrounding tissue.

[0041] Figure 4 provides an example of how images generated by the ultrasound probe 201 are integrated into a display along with various information obtained from the images and readings from the sensor 207. As shown, this display can be generated and / or presented on the base unit 205 and / or any number of monitoring devices 400. This display may include one or more views of the catheter 102 within the vascular system 501, such as the cross-sectional view in Figure 3B and the section view in Figure 3C. The cross-sectional view allows the clinician to see how the catheter 102 extends into the vascular system 501, and thus it becomes easier to quickly determine whether the catheter 102 is fully inserted, whether the distal end 102a is properly positioned, whether there is an occlusion, or any other condition that can be detected by ultrasound. The section view allows the clinician to see how a particular portion of the catheter 102 is positioned within the vascular system 501, and thus it becomes easier to quickly determine whether the catheter 102 is excessively restricting blood flow through the vascular system 501, or any other condition that can be detected 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 move the cross-sectional view along the length of the catheter 102 to determine whether there is excessive occlusion in any part along the length of the catheter 102.

[0042] Figure 4 also shows that the display may include various information obtained from the image generated by the ultrasound probe 201, the readings of the sensor 207, or input. For example, the display may include indicator 601a showing the gauge of the catheter 102 and indicator 601b showing the length of the catheter 102. Indicators 601a and 601b can be obtained from user input or calculated from the image generated by the ultrasound probe 201.

[0043] The display also includes indicators 602a, 602b, 602c, and 602d that show various parameters. In some embodiments, these parameters can be selectable. For example, in Figure 4, indicator 602a provides information on when the catheter 102 was last flushed. This last flush information can be calculated using an image generated by the ultrasound probe 201. For example, by applying Doppler technology to the image data, it is possible to detect whether fluid is leaking from the distal end 102a, and in response to this detection, the base unit 205 (or monitoring device 400) stores information indicating that a flush occurred at that time. Indicator 602b identifies whether infiltration has occurred and can be determined from a combination of readings from sensor 207 and, in some cases, images from ultrasound probe 201. Indicator 602c provides the current blood oxygen concentration from sensor 207, in this case a pulse oximeter. Indicator 602d provides the temperature obtained from another sensor 207, in this case a thermometer.

[0044] The display further includes indicators 603a and 603b that provide information about the portion of the catheter 102 within the vascular system 501. Indicator 603a shows the catheter-to-vein ratio (i.e., the ratio of the catheter diameter to the vein diameter at a particular location). Indicator 603b shows the length of the catheter 102 (i.e., the length of the catheter 102 within the vascular system 501). The display also includes indicator 604 that indicates the patency status of the catheter 102 (i.e., whether the catheter 102 can remain safely within the vascular system 501). The base unit 205 (or monitoring device 400) can calculate the patency status using images provided by the ultrasound probe 201 (e.g., to detect the extent to which the catheter 102 and / or the vascular system 501 surrounding the catheter 102 are occluded).

[0045] As suggested above, the vascular access system 50 can be configured to monitor and / or display information about the state of the catheter 102, the vascular system 501, or the surrounding tissue, and various associated physiological or procedural parameters, utilizing images provided by the ultrasound probe 201 and / or readings from sensors 207 in an integrated sensor array. This information includes catheter shape information (e.g., catheter-to-vein ratio, catheter length, blood 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 migration, catheter twisting, dislodgement events, extravasation, infiltration detection (e.g., by monitoring the tissue around the vascular system 501), thrombus formation, phlebitis (visual or correlated cumulative movement), patency indicators, blood flow characteristics (e.g., by detecting the velocity and / or volume of blood flowing into catheter 102 using Doppler), fluid administration flow characteristics (e.g., by detecting the velocity, volume, direction, and / or duration of fluid flow using Doppler), procedure events (e.g., flush, draw, fluid administration), and / or the position of the line draw tube, probe or sensor within the vein or the distal end of the catheter or relative to physiological features (thrombus, valve, wall, branch, etc.).

[0046] The vascular access system 50 may provide a display including an indicator showing any of the information described above and provide corresponding warnings. For example, the base unit 205 or monitoring device 400 may be configured to output a visual, auditory, tactile, or digital warning when a condition or event is detected from the ultrasound image or sensor readings. In some embodiments, the ultrasound probe 201, electrical adapter 203, cable 204, wireless adapter 206, and / or sensor 207 may include one or more warning mechanisms (e.g., LEDs, speakers, tactile units, etc.) for providing warnings.

[0047] Figure 5 provides an example of how the base unit 205 (or possibly the monitoring device 400) is configured to generate display content from ultrasonic images and sensor readings. This display content includes the aforementioned information, indicators, states, events, warnings, etc. (collectively referred to as “parameters”). Figure 4 is an example of display content.

[0048] The base unit 205 may be configured to receive ultrasound images from the ultrasound probe 201 and readings from the sensor 207 continuously, periodically, on demand, etc. The base unit 205 may include an image processor 205a configured to process the ultrasound images to generate processed image data. This processed image data can be input to an artificial intelligence engine 205b, which may be configured to detect and / or generate parameters from the processed image data. The parameters are provided to a display module 205c along with the ultrasound images, and the display module 205c can generate display content including the images and parameters. Sensor readings may be provided to the display module 205c to be included in the display content. In some embodiments, sensor readings are input to the artificial intelligence engine 205b and used alone or in combination with the processed image data to generate parameters.

[0049] In some embodiments, the image processor 205a may be configured to determine from an image or sequence of images various state information, such as the shape or position of the catheter, or the presence of a thrombus, twist, or other occlusion. In some embodiments, the artificial intelligence engine 205b may be trained to detect the presence of parameters in a stream of ultrasound images and / or sensor readings. For example, the artificial intelligence engine 205b may detect when a sequence of ultrasound images indicates a flash event, a draw event, the occurrence of extravasation, detachment, or displacement event.

[0050] All examples and conditional language described herein are for educational purposes only to help the reader understand the present invention and the concepts to which the inventors have contributed to advancing the art, and are construed as not being limited to such specifically described examples and conditions. While embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made herein without departing from the spirit and scope of the invention.

Claims

1. Vascular access devices including catheters, An ultrasound assembly comprising an ultrasound probe and a sensor array, wherein the ultrasound probe is configured to be positioned on the catheter when the catheter is inserted into a patient's blood vessel, A base unit configured to receive images from the ultrasonic probe and readings from the sensor array, A vascular access system equipped with [the following features].

2. The ultrasonic assembly includes a cable connecting the ultrasonic probe and the sensor array to the base unit. The vascular access system according to claim 1.

3. The ultrasonic assembly includes a wireless adapter for wirelessly connecting the ultrasonic probe and the sensor array to the base unit. The vascular access system according to claim 1.

4. The system further comprises a fixation dressing configured to fix the ultrasound probe and the sensor array onto the catheter. The vascular access system according to claim 1.

5. The base unit is configured to generate display content from the image and the readings, and to transmit the display content to one or more monitoring devices. The vascular access system according to claim 1.

6. The base unit is configured to generate one or more parameters from the image and the readings, and to include the one or more parameters in the display content. The vascular access system according to claim 5.

7. The aforementioned parameters include information about the shape or position of the catheter. The vascular access system according to claim 6.

8. The parameters include one or more of the following: catheter movement or migration, catheter twisting, detachment events, extravasation, infiltration detection, thrombus formation, phlebitis, patency indicators, blood flow characteristics, fluid administration flow rate characteristics, procedure events, or line draw tube, probe or sensor position. The vascular access system according to claim 6.

9. A method for using a vascular access system, Inserting a catheter for a vascular access device into the patient's vascular system, Placing an ultrasound assembly, including an ultrasound probe and a sensor array, on the patient's skin over a portion of the catheter inserted into the patient's vascular system, A connection is established between the ultrasound assembly and the base unit, thereby enabling the base unit to receive ultrasound images from the ultrasound probe and readings from the sensor array, wherein the ultrasound images capture a portion of the catheter inserted into the patient's vascular system. Methods that include...

10. The aforementioned connection is wireless or wired. The method according to claim 9.

11. The further includes placing a fixing dressing material on the catheter adapter from which the ultrasound probe, the sensor array, and the catheter extend. The method according to claim 9.

12. A method for monitoring a catheter, Receiving an image of the catheter from an ultrasound probe placed on the catheter while it is inserted into the patient's vascular system, Receiving readings from a sensor array integrated with the aforementioned ultrasonic probe, The image and the readings are processed to determine one or more parameters, To generate display content including the one or more parameters, Methods that include...

13. Processing the aforementioned image and the aforementioned readings to determine one or more parameters includes determining shape or position information, or a catheter, line draw tube, probe, or sensor. The method according to claim 12.

14. Processing the aforementioned image and the aforementioned readings to determine one or more parameters includes detecting the movement or motion of the catheter. The method according to claim 12.

15. Processing the aforementioned images and readings to determine one or more parameters includes detecting extravasation or infiltration. The method according to claim 12.

16. Processing the aforementioned images and readings to determine one or more parameters includes detecting thrombosis or phlebitis. The method according to claim 12.

17. Processing the aforementioned images and readings to determine one or more parameters includes determining blood or fluid administration flow rate characteristics. The method according to claim 12.

18. Processing the aforementioned image and the aforementioned readings to determine one or more parameters includes detecting a treatment event. The method according to claim 12.

19. The display content also includes at least some of the images. The method according to claim 12.

20. The one or more of the above parameters are determined using artificial intelligence. The method according to claim 12.

Images