Vascular access systems and methods for continuous ultrasound monitoring

Abstract

Vascular access systems and methods for continuous ultrasound monitoring are disclosed. A 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 may be positioned over a catheter inserted into a patient's vasculature. Images from the ultrasound probe 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 Art

[0001] Catheters are commonly used in various infusion therapies. For example, catheters can be used to infuse therapeutic agents or fluids into a patient. Catheters can also be used to draw blood from a patient. A variety of catheters are commonly used in medical settings, including, for example, peripherally inserted central catheters, midline catheters, central venous catheters, dialysis catheters, and arterial catheters. One common type of catheter device includes an over-the-needle catheter. As the name implies, an over-the-needle catheter can be mounted on an introducer needle having a sharp distal tip.

[0002] The catheter and introducer needle can be assembled so that the distal end of the introducer needle extends beyond the distal end of the catheter and the bevel of the needle faces away from the patient's skin. The catheter and introducer needle are usually inserted through the skin at a shallow angle into the patient's vascular system. In order to verify the correct placement of the introducer needle and / or catheter in the blood vessel, the clinician usually confirms the presence of 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 draws or fluid infusions.

[0003] Although catheter retention performance (i.e., how long a catheter can safely remain in the vasculature) has improved in recent years, there are still a number of complications that can occur during the expected dwell time of a vascular access device. These complications may include dislocation, infiltration, extravasation, phlebitis, catheter-related infection, and loss of patency.

[0004] 1 illustrates a prior art piezoelectric transducer array 10 (or ultrasound probe 10) for performing ultrasound. The ultrasound probe 10 is conformable and thus can 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 described above. Rather, this background is merely provided to illustrate one example technology area in which some implementations described herein may be practiced. Summary of the invention

[0006] The present disclosure generally relates to vascular access devices, systems and methods. In particular, the present disclosure relates to vascular access systems and methods for continuous ultrasound monitoring. 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 above a catheter inserted into a patient's vascular system. Images from the ultrasound probe can be processed to generate parameters representing a state, event or other information about the catheter. Display content including the image and the parameters can be provided to the monitoring device.

[0007] In some embodiments, the vascular access system may include a vascular access device, which includes a catheter, an ultrasound component and a base unit, the ultrasound component includes an ultrasound probe, the ultrasound probe is configured to be positioned above the catheter when the catheter is inserted into the patient's vascular system, and the base unit is configured to receive images from the ultrasound probe.

[0008] In some embodiments, the ultrasound assembly may include a cable connecting the ultrasound probe to the base unit.

[0009] In certain embodiments, the ultrasound assembly may include a wireless adapter that may wirelessly connect the ultrasound probe to the base unit.

[0010] In some embodiments, the vascular access system may include a fixation dressing configured to secure the ultrasound probe over the catheter.

[0011] In some embodiments, the base unit may be configured to generate a display from the images and transmit the display to one or more monitoring devices.

[0012] In some embodiments, the base unit may be configured to generate one or more parameters from the image and include the one or more parameters in the display content.

[0013] In some embodiments, the parameters may include geometric information or position information of the catheter.

[0014] In some embodiments, the parameters may include one or more of the following: catheter movement or displacement, catheter kinking, slippage event, extravasation, infiltration detection, thrombosis, phlebitis, patency indicator, blood flow characteristics, fluid administration flow characteristics, procedural events, or location of a line extraction tube, probe, or sensor.

[0015] In some embodiments, a method of using a vascular access system includes inserting a catheter of a vascular access device into the vascular system of a patient; positioning an ultrasound probe of an ultrasound assembly on the patient's skin, above the portion of the catheter inserted into the patient's vascular system; and establishing a connection between the ultrasound probe and a base unit so that the base unit can receive an ultrasound image from the ultrasound probe, wherein the ultrasound image reflects the portion of the catheter inserted into the patient's vascular system.

[0016] In some embodiments, the connection is wired or wireless.

[0017] In some embodiments, the method may further include placing a fixation dressing over the ultrasound probe and the catheter adapter from which the catheter extends.

[0018] In some embodiments, a method for monitoring a catheter may include: receiving an image from an ultrasound probe positioned above a catheter inserted into a patient's vasculature, the image reflecting the catheter; processing the image to determine one or more parameters; and generating a display including the one or more parameters.

[0019] In some embodiments, processing the image to determine one or more parameters may include determining geometric information or position information of a catheter, line extraction tubing, probe, or sensor.

[0020] In some embodiments, processing the images to determine one or more parameters may include detecting catheter motion or displacement.

[0021] In some embodiments, processing the image to determine one or more parameters may include detecting extravasation or infiltration.

[0022] In some embodiments, processing the images to determine one or more parameters may include detecting thrombosis or phlebitis.

[0023] In some embodiments, processing the images to determine one or more parameters may include determining blood or fluid administration flow characteristics.

[0024] In some embodiments, processing the image to determine one or more parameters may include detecting a procedural event.

[0025] In some embodiments, the display content may also include at least some of the images.

[0026] In some embodiments, artificial intelligence may be used to determine one or more parameters.

[0027] It should be understood that the foregoing general description and the following detailed description are examples and explanatory descriptions and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means illustrated in the accompanying drawings. It should also be understood that these embodiments can be combined, or other embodiments can be utilized, and unless so stated, structural changes can be made without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description should not be regarded as limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Additional specific features and details of example embodiments will be described and explained through the use of the accompanying drawings, in which:

[0029] FIG1 illustrates a prior art piezoelectric transducer array for performing ultrasound;

[0030] Figure 2A Examples of vascular access systems configured in accordance with one or more embodiments are provided;

[0031] Figure 2B Another example of a vascular access system configured in accordance with one or more embodiments is provided;

[0032] Figure 3A a partial cross-sectional view of a vascular access device configured in accordance with one or more embodiments when placed on the skin;

[0033] Figure 3B is a lateral view of a vein having a catheter inserted therein, which lateral view may be generated by a vascular access device configured according to one or more embodiments;

[0034] Figure 3C is a cross-sectional view of a vein having a catheter inserted therein, which cross-sectional view may be generated by a vascular access device configured according to one or more embodiments;

[0035] Figure 4 is an example display that may be generated by a vascular access system configured in accordance with one or more embodiments;

[0036] Figure 5 Examples of electronic components that may be included in a base unit or monitoring device of a vascular access system in one or more embodiments are provided. DETAILED DESCRIPTION

[0037] Reference Figure 2A In some embodiments, a 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., a wing extending outward from the catheter adapter 101); a needle access port 104 through which an introducer needle (not shown) may be inserted through the catheter adapter 101 and the catheter 102; a near-patient access port 105 that may be connected to a side port of the catheter adapter 101; an extension tube 106 having a clamp 107 and a Luer adapter 108 connected to the extension tube 106; and an access port 109 coupled to the Luer adapter 108. This is just one example of various different configurations of vascular access devices that may be used in a vascular access system configured according to embodiments of the present disclosure.

[0038] The ultrasound assembly 200 may include an ultrasound probe 201; a fixing mechanism 202 for fixing the ultrasound probe 201 to the skin and / or the catheter 102; an electrical adapter 203 through which a cable 204 is connected to the ultrasound probe 201; and a base unit 205 to which the cable 204 can be connected so that the base unit 205 can communicate with the ultrasound probe 201. In some embodiments, the fixing mechanism 202 can be an adhesive film on the underside of the ultrasound probe 201, which can be used to adhere the ultrasound probe 201 directly to the patient's skin above the catheter 102. In some embodiments, the fixing mechanism 202 can 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 can be detachable from the ultrasound probe 201, while in other embodiments, the electrical adapter 203 can be integrated with the ultrasound probe 201. The base unit 205 can be any device that includes a circuit system for communicating with the ultrasound probe 201. In some embodiments, the base unit 205 can provide power to the ultrasound probe 201. In some embodiments, the base unit 205 may directly process images received from the ultrasound probe 201, while in other embodiments, the base unit 205 may receive images from the ultrasound probe 201 and forward the images to another device for processing. In some embodiments, the base unit 205 may include a user input element to allow a user (e.g., a clinician and / or a patient) to control the ultrasound probe 201. In some embodiments, the base unit 205 may be connected to one or more other devices to allow a user of the one or more other devices to control the ultrasound probe 201.

[0039] The size and shape of the fixation dressing 300 can be set to be suitable for covering and fixing the ultrasound probe 201 and the catheter adapter 101 against the patient's skin. For example, in some embodiments, the fixation dressing 300 can completely cover the catheter adapter 101 and can include an opening through which the extension tube 106 extends. The underside of the fixation dressing 300 can be adhesive to prevent it from moving after the fixation dressing 300 is placed on the skin. In some embodiments, a transparent window 301 can be formed in the fixation dressing 300 to facilitate viewing of the catheter 102 and the ultrasound probe 201.

[0040] 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 and the catheter adapter 101. In any case, the ultrasound probe 201 may be positioned on the patient's skin so that when the catheter 102 is inserted into the patient's vasculature, the ultrasound probe 201 is located over the distal tip of the catheter 102.

[0041] The monitoring device(s) 400 may represent any device having a display on which images generated by the ultrasound probe 201 may be displayed and / or on which information obtained from these images may be displayed. As examples, the monitoring device(s) 400 may include a smartphone, 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, the monitoring device 400 may be used as a base unit 205. The monitoring device 400 may also be configured to interact with one or more separate computing systems, such as a system for storing patient data.

[0042] Figure 2B Another example configuration of the vascular access system 50 is provided in which a wireless adapter 206 is used in place of the cable 204. The wireless adapter 206 can be configured to transmit images generated by the ultrasound probe 201 to the base unit 205 or possibly to the monitoring device(s) 400. The wireless adapter 206 can also include a battery to power the ultrasound probe 201. In some embodiments, the wireless adapter 206 can be integrated into the electrical adapter 203, while in other embodiments, the wireless adapter 206 can be selectively coupled to the electrical adapter 203.

[0043] Figure 2A and Figure 2B An example is provided in which the vascular access system 50 includes a peripheral intravenous catheter. However, a vascular access system configured according to embodiments of the present disclosure can be used with a central venous catheter, a peripherally inserted central catheter, a midline catheter, an arterial catheter, a port, a venipuncture, a subcutaneous access device, or other indwelling catheter, probe, sensor, or instrument.

[0044] Figure 3Ais a partial cross-sectional view of the vascular access system 50 when in use 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 the fixing mechanism 202. The fixing dressing 300 can be positioned above 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 generate ultrasound images of the portion of the vascular system 501 where the catheter 102 extends (including surrounding tissue) in a continuous manner, a periodic manner, an on-demand manner, etc. For example, Figure 3B is an image showing a lateral view of the vasculature 501, the catheter 102, and the distal tip 102a, and Figure 3C is an image showing a cross-sectional view of the vasculature 501 and the catheter 102 .

[0045] Figure 4 An example of how an image generated by ultrasound probe 201 may be integrated into a display along with various information derived from the image. As indicated, this display may be generated and / or presented on base unit 205 and / or any number of monitoring devices 400. This display may include one or more views of catheter 102 within vascular system 501, such as Figure 3B Lateral view and Figure 3C The lateral view may allow the clinician to see how the catheter 102 extends into the vascular system 501, and thus may help to quickly determine whether the catheter 102 is fully inserted, whether the distal end 102a is properly positioned, whether there are any blockages, or any other conditions that can be detected via ultrasound. The cross-sectional view may allow the clinician to see how a particular portion of the catheter 102 is positioned within the vascular system 501, and thus may help to quickly determine whether the catheter 102 may be overly restricting blood flow through the vascular system 501 or any other conditions that can be detected via 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 the catheter 102 to determine whether there is excessive blockage at any portion along the length of the catheter 102.

[0046] Figure 4 It is also illustrated that the display may include various information that may be derived from the image generated by the ultrasound probe 201 or derived from the input. For example, the display includes an indicator 601a of the gauge of the catheter 102 and an indicator 601b of the length of the catheter 102. The indicators 601a and 601b may be obtained via user input or may be calculated based on the image generated by the ultrasound probe 201.

[0047] The display also includes indicators 602a, 602b, and 602c for different parameters. In some embodiments, these parameters are selectable. For example, in Figure 4 In FIG. 1 , indicator 602a provides information about when the catheter 102 was last flushed. This last flush information can be calculated using the images produced by the ultrasound probe 201. For example, Doppler techniques can be applied to the image data to detect when fluid flows out through the distal tip 102a, and in response to such detection, the base unit 205 (or monitoring device 400) can store an indication that flushing has occurred at this time. Figure 4 In the example shown in FIG. 5 , indicators 602 b and 602 c are not selected. However, these indicators can be selected to display information for many different situations, events, states, etc., as described below.

[0048] The display also includes indicators 603a and 603b providing information about the portion of the catheter 102 that is within the vasculature 501. Indicator 603a defines the catheter to vein ratio (i.e., the ratio of the catheter diameter to the vein diameter at a particular location). Indicator 603b defines the purchase of the catheter 102 (i.e., the length of the catheter 102 that is within the vasculature 501). The display additionally includes an indicator 604 that defines the patency status of the catheter 102 (i.e., whether the catheter 102 can be safely retained within the vasculature 501). The base unit 205 (or monitoring device 400) can use the image provided by the ultrasound probe 201 to calculate the patency status (e.g., detect the extent to which the catheter 102 and / or the vasculature 501 surrounding the catheter 102 may be blocked).

[0049] As suggested above, vascular access system 50 may be configured to monitor and / or display information related to the status of catheter 102 , vasculature 501 , or surrounding tissue, and various associated physiological or procedural parameters by utilizing images provided by ultrasound probe 201 . This information includes catheter geometry information (e.g., catheter to vein ratio, catheter delivery, flow restrictions around the catheter), catheter position information (axial position of the catheter within the vein, position or angle of the distal tip of the catheter relative to the vein wall, valves, branches, or other physiological features), catheter motion or displacement, catheter kinking, slippage events, extravasation, infiltration detection (e.g., by monitoring tissue surrounding the vasculature 501), thrombosis, phlebitis (visual or correlated cumulative motion), patency indicators, blood flow characteristics (e.g., by using Doppler to detect the rate and / or amount of blood flowing into the catheter 102), fluid administration flow characteristics (e.g., by using Doppler to detect the rate, amount, direction, and / or duration of fluid flow), procedural events (e.g., flushing, withdrawal, fluid administration), and / or the position of a line withdrawal tubing, probe, or sensor in the vein or relative to the distal tip of the catheter or physiological features (e.g., thrombus, valve, wall, branch, etc.).

[0050] The vascular access system 50 may provide a display of indicators including any of the above information, and may provide corresponding alarms. For example, the base unit 205 or the monitoring device 400 may be configured to output a visual, audible, tactile, or digital alarm when a condition or event is detected from an ultrasound image. In some embodiments, the ultrasound probe 201, the electrical adapter 203, the cable 204, and / or the wireless adapter 206 may include one or more alarm mechanisms (e.g., LEDs, speakers, tactile units, etc.) to provide an alarm.

[0051] Figure 5 An example is provided of how the base unit 205 (or possibly the monitoring device 400) may be configured to generate a display from an ultrasound image. This display may include any of the above-mentioned information, indicators, states, events, alarms, etc. (collectively referred to as "parameters"). Figure 4 is an example of what is displayed.

[0052] The base unit 205 may be configured to receive ultrasound images from the ultrasound probe 201 in a continuous manner, a periodic manner, an on-demand manner, etc. The base unit 205 may include an image processor 205a, which is configured to process the ultrasound image to generate processed image data. This processed image data may be input to an artificial intelligence engine 205b, which may be configured to detect and / or generate parameters based on the processed image data. The parameters may be provided to a display module 205c together with the ultrasound image, and the display module 205c may generate a display content including the image and the parameters.

[0053] In some embodiments, the image processor 205a may be configured to determine various status information based on an image or image sequence, such as catheter geometry or position information, or the presence of a thrombus, kink, or other blockage. In some embodiments, the artificial intelligence engine 205b may be trained to detect when parameters are present in an ultrasound image stream. For example, the artificial intelligence engine 205b may detect when an ultrasound image sequence indicates a flushing event, an extraction event, the occurrence of extravasation, a slippage or motion event, etc.

[0054] All examples and conditional language described herein are intended for teaching purposes to help readers understand the present invention and the concepts contributed by the creators of the present invention to expand the art, and should be interpreted as not being limited to such specific examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the present invention.

Claims

1. A vascular access system, the vascular access system include: a vascular access device, the vascular access device comprising a catheter; an ultrasound assembly including an ultrasound probe configured to be positioned over the catheter when the catheter is inserted into the vasculature of a patient; as well as A base unit is configured to receive images from the ultrasound probe.

2. The vascular access system according to claim 1, in, The ultrasound assembly includes a cable connecting the ultrasound probe to the base unit.

3. The vascular access system according to claim 1, in, The ultrasound assembly includes a wireless adapter that wirelessly connects the ultrasound probe to the base unit.

4. The vascular access system according to claim 1, wherein the vascular access system further comprises: include: A fixation dressing is configured to fix the ultrasound probe over the catheter.

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

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

7. The vascular access system according to claim 6, in, The parameters include geometric information or position information of the catheter.

8. The vascular access system according to claim 6, in, The parameters include one or more of the following: catheter movement or displacement, catheter kinking, slippage event, extravasation, infiltration detection, thrombosis, phlebitis, patency indicator, blood flow characteristics, fluid administration flow characteristics, procedural events, or location of a line extraction tube, probe or sensor.

9. A method of using a vascular access system, the method include: inserting a catheter of a vascular access device into the vasculature of a patient; positioning an ultrasound probe of the ultrasound assembly on the patient's skin over the portion of the catheter that is inserted into the patient's vasculature; and A connection is established between the ultrasound probe and the base unit so that the base unit can receive an ultrasound image from the ultrasound probe, wherein the ultrasound image represents the portion of the catheter inserted into the patient's vasculature.

10. The method according to claim 9, in, The connection may be wired or wireless.

11. The method according to claim 9, further comprising: include: A fixation dressing is placed over the ultrasound probe and the catheter adapter from which the catheter extends.

12. A method for monitoring a catheter, wherein include: receiving an image from an ultrasound probe positioned over a catheter inserted into a patient's vasculature, the image reflecting the catheter; processing the image to determine one or more parameters; and A display content is generated that includes the one or more parameters.

13. The method according to claim 12, in, Processing the image to determine one or more parameters includes determining geometric information or position information of the catheter, line extraction tubing, probe, or sensor.

14. The method according to claim 12, in, Processing the images to determine one or more parameters includes detecting catheter motion or displacement.

15. The method according to claim 12, in, Processing the image to determine one or more parameters includes detecting extravasation or infiltration.

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

17. The method according to claim 12, in, Processing the images to determine one or more parameters includes determining blood or fluid administration flow characteristics.

18. The method according to claim 12, in, Processing the image to determine one or more parameters includes detecting a procedural event.

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

20. The method according to claim 12, in, Artificial intelligence is used to determine the one or more parameters.

Images