Imaging system and method for implantation evaluation and data integration of integrated vascular access devices

Abstract

Imaging systems and methods are provided for in-well evaluation and data integration of integrated vascular access devices. Using such imaging systems and methods, the status of indwell integrated vascular access devices and the overall functionality of vascular access in acute care and alternative site setting can be better evaluated and monitored, reducing patient complications and experience, clinician burden, and the overall effectiveness of patient treatment and care. Such imaging systems and methods can also facilitate the use of imaging devices, such as ultrasound devices, to evaluate the current status of indwell vascular access devices and compare it to previous status or established clinical criteria. This can facilitate the predictive detection, identification, and / or diagnosis of emerging risks of catheter-related complications, or the intermittent and consistent detection of actual complications.

Description

Technical Field

[0001] The present invention generally relates to imaging systems and methods for the placement evaluation and data integration of an integrated vascular access device.

Background Art

[0002] Vascular access devices are commonly used in various infusion therapies. For example, a vascular access device can be used to inject a therapeutic agent or fluid into a patient. A vascular access device may also be used to collect blood from a patient. There are various vascular access devices commonly used in a medical environment, such as a peripherally inserted central catheter, a midline catheter, a central venous catheter, a dialysis catheter, and an arterial catheter.

[0003] One common type of vascular access device includes an over-the-needle catheter. As the name indicates, an over-the-needle catheter can be mounted on a introducer needle having a sharp distal tip. The catheter and the introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle faces away from the patient's skin. The catheter and the introducer needle are typically inserted into the patient's vascular system at a shallow angle from the skin. To verify the proper placement of the introducer needle and / or the catheter within the blood vessel, a clinician generally confirms that there is a "flashback" of blood in the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the catheter can be left in place for future blood sampling or fluid infusion.

[0004] While catheter placement performance (i.e., the time a catheter can safely remain in the vascular system) has improved in recent years, a significant number of complications remain that can develop throughout the intended duration of vascular access devices. These complications may include infiltration, extravasation, displacement, occlusion, loss of patency, infection, catheter twisting, catheter migration, thrombosis, and phlebitis. These complications may also include local physiological changes in the patient, such as changes in vein or artery size, collapse, sclerosis, injury, and other changes that may accelerate the development of further complications.

[0005] The subject matter claimed herein is not limited to embodiments that resolve any of the aforementioned shortcomings, or embodiments that operate only in the aforementioned environment. Rather, this background art is provided merely to illustrate an example of the technical area in which some of the embodiments described herein may be carried out. [Overview of the Initiative]

[0006] This disclosure relates, in general, to imaging systems and methods for the implantation evaluation and data integration of integrated vascular access devices. Using such imaging systems and methods, the status of implanted integrated vascular access devices and the overall functionality of vascular access in acute care and alternative site setting can be better evaluated and monitored, reducing patient complications and experience, clinician burden, and the overall effectiveness of patient treatment and care. Such imaging systems and methods can also facilitate the use of imaging devices, such as ultrasound devices, to evaluate the current status of implanted vascular access devices and compare it to previous status or established clinical criteria. This can facilitate the predictive detection, identification, and / or diagnosis of emerging risks of catheter-related complications, or the intermittent and consistent detection of actual complications.

[0007] Embodiments of the present disclosure may be implemented as a fixed platform including a base layer, a vascular access device pocket formed in the base layer, a catheter insertion site window formed in the base layer distal to the vascular access device pocket, and an imaging device pocket.

[0008] In some embodiments, the vascular access device pocket may be molded and sized to accommodate the stabilization platform of the vascular access device.

[0009] In some embodiments, the vascular access device pocket may be a notch in the base layer.

[0010] In some embodiments, the vascular access device pocket may include an adhesive portion on the upper surface of the base layer.

[0011] In some embodiments, the catheter insertion site window may overlap with the vascular access device pocket.

[0012] In some embodiments, the window of the catheter insertion site may be spaced apart from the vascular access device pocket.

[0013] In some embodiments, the imaging device pocket may be formed in the base layer.

[0014] In some embodiments, the base layer may be formed as a separate component from the vascular access device pocket and catheter insertion site window.

[0015] In some embodiments, the fixed platform may include guides that at least partially surround the imaging device pocket.

[0016] In some embodiments, the guide may extend over the base layer.

[0017] In some embodiments, the imaging device pocket may include a gel cap.

[0018] In some embodiments, the fixation platform may include a fixation dressing configured to be placed on at least a portion of the fixation platform. The fixation dressing may have a transparent window positioned above the window of the catheter insertion site.

[0019] Embodiments of the present disclosure may be implemented as an imaging system including a fixed platform and a base unit. The fixed platform may include a base layer, a vascular access device pocket formed in the base layer, a catheter insertion site window formed in the base layer distal to the vascular access device pocket, and an imaging device pocket. The base unit may be configured to receive images from an imaging device placed within the imaging device pocket when the imaging device pocket is positioned over the distal tip of a catheter inserted into the patient's vascular system.

[0020] In some embodiments, the base unit may include an artificial intelligence engine configured to detect the depth of the distal tip of the catheter from an image.

[0021] In some embodiments, the imaging system may include one or more monitoring devices for displaying display content derived from the image.

[0022] In some embodiments, the fixed platform may include a fixed dressing.

[0023] In some embodiments, the fixed platform may include a first component including a vascular access device pocket and a catheter insertion site window, and a second component including an imaging device pocket.

[0024] In some embodiments, the imaging system may include a vascular access device having a stabilization platform. The vascular access device pocket may be configured to receive the stabilization platform.

[0025] Embodiments of the present disclosure may be implemented as a method for obtaining an image of a patient's vasculature. The fixation platform may be placed on the patient. The fixation platform may include an imaging device pocket. The imaging device pocket can be placed on a catheter inserted through the patient's vasculature. The imaging device is placed within the imaging device pocket to obtain one or more images of the catheter.

[0026] In some embodiments, the fixation platform may also include a base layer, a vascular access device pocket formed in the base layer, and a catheter insertion site window formed in the base layer distal to the vascular access device pocket.

[0027] It should be understood that both the foregoing summary description and the following detailed description are exemplary and explanatory and are not restrictive of the claimed invention. It should be understood that various embodiments are not limited to the arrangements and means shown in the figures. Also, embodiments may be combined or other embodiments may be used, and structural changes may be made without departing from the scope of various embodiments of the present invention, unless so claimed. Accordingly, the following detailed description should not be construed in a limiting sense.

Brief Description of the Drawings

[0028] Exemplary embodiments are described and explained more specifically and in detail by using the accompanying drawings. [Figure 1A]Figure 1A shows a prior art vascular access device that can be used in one or more embodiments of the present disclosure. [Figure 1B] Figure 1B shows a fixed platform configured according to one or more embodiments of the present disclosure. [Figure 2] Figure 2 shows an imaging system configured according to one or more embodiments of the present disclosure. [Figure 3] Figure 3 shows another fixed platform configured according to one or more embodiments of the present disclosure. [Figure 4] Figure 4 shows another fixed platform configured according to one or more embodiments of the present disclosure. [Figure 5A] Figure 5A shows another fixed platform configured according to one or more embodiments of the present disclosure. [Figure 5B] Figure 5B shows the fixed platform of Figure 5A when used with a vascular access device. [Figure 5C] Figure 5C shows the fixed platform of Figure 5A when a fixed dressing is used to secure the vascular access device. [Figure 6A] Figure 6A is a block diagram of components of an imaging system configured according to one or more embodiments of the present disclosure. [Figure 6B] Figure 6B is a flowchart depicting how embodiments of the present disclosure can be used throughout the continuum of care. [Figure 7A] Figure 7A is a cross-sectional view of a vascular system when an imaging system is used according to one or more embodiments of the present invention. [Figure 7B] Figure 7B is an exemplary image generated by the imaging system of Figure 7A. [Figure 7C] Figure 7C is an exemplary image generated by the imaging system of Figure 7A. [Figure 8]Figure 8 is an exemplary representation that may be generated by an imaging system configured according to one or more embodiments of the present disclosure. [Figure 9] Figure 9 provides examples of electronic components that may be included in one or more embodiments of the present disclosure as a base unit or monitoring device for an imaging system. [Modes for carrying out the invention]

[0029] In this specification and in the claims, the term “continuity of care” is intended to represent the entire period of vascular access, including pre-insertion, during insertion, during placement, and post-removal. “Vascular access device” should be interpreted to include intravenous catheter devices and any other devices that can access a patient’s vascular system. “Vascular access data” should be interpreted to include any data relating to access to a patient’s vascular system using a vascular access device, including images of the patient’s vascular system, characteristics of the vascular access device, information regarding the placement and / or removal of the vascular access device, information regarding events occurring during the placement of the vascular access device, detected complications, patient vital signs, fluid and blood flow characteristics, etc.

[0030] Figure 1A provides an example of a vascular access device 100 from which an imaging system configured according to embodiments of the present disclosure may be used. The vascular access device 100 includes a catheter adapter 110 from which a catheter 111 extends. The catheter adapter 111 may also include a side port 112 from which an extension set 114 is connected. The vascular access device 100 may also include a stabilization platform 113 for stabilizing the catheter adapter 111 when placed in a patient. The vascular access device 100 is just one example of many vascular access devices that may be used as part of embodiments of the present disclosure. For example, embodiments of the present disclosure may be used with central venous catheters (CVCs), peripherally inserted central venous catheters (PICCs), midline catheters, arterial catheters, peripheral venous catheters (PIVCs), long PIVCs, venous puncture devices, subcutaneous access devices, and other indwelling tubes, probes, sensors, or instrument devices.

[0031] Figure 1B provides an example of a fixed platform 200 configured according to one or more embodiments of the present disclosure. The fixed platform 200 is configured for use with a vascular access device 100 and can be positioned beneath the vascular access device 100 during use, as shown in Figure 2. The fixed platform 200 includes a base layer 201, the back surface of which an adhesive may be applied to allow the fixed platform 200 to adhere to the patient's skin. The base layer 201 may also include a vascular access device pocket 202 that can be shaped and sized to substantially match a stabilization platform 113. In some embodiments, the vascular access device pocket 202 may be a cutout that exposes the patient's skin, thereby allowing the stabilization platform 113 to be placed directly on the skin. In other embodiments, the vascular access device pocket 202 may be part of the base layer 201 having an adhesive on its upper surface so that the stabilization platform 113 can adhere to the base layer 201.

[0032] The fixed platform 200 also includes a catheter insertion site window 203 positioned distal to the vascular access device pocket 202, allowing the catheter 111 to pass through the fixed platform 200 and enter the patient's vascular system when the catheter adapter 110 is placed on the fixed platform 200. In some embodiments, the catheter insertion site window 203 may be molded and sized to accommodate an antimicrobial patch or pad, or to allow the application and containment of a skin adhesive to seal the insertion site. In some embodiments, a slot (not shown) may be formed in the base layer 201 and may extend between the catheter insertion site window 203 and the periphery of the base layer 201, allowing the fixed platform 200 to be positioned under the vascular access device 100 after the catheter 111 has been inserted.

[0033] The stabilization platform 200 also includes an imaging device pocket 204 positioned distal to the catheter insertion site window 203. The imaging device pocket 204 can be spaced apart from the catheter insertion site window 203 by a distance corresponding to the length of the catheter 111. In other words, the imaging device pocket 204 can be positioned to cover the distal end of the catheter 111 when the catheter 111 is inserted into the vascular system and the stabilization platform 113 is positioned in the vascular access device pocket 202. In some embodiments, the imaging device pocket 204 may be a cutout that exposes the patient's skin. In other embodiments, the imaging device pocket 204 may be formed from a gel cap to facilitate imaging. The size and shape of the imaging device pocket 204 can be selected to accommodate a range of imaging device head shapes and orientations, including rectangular, square, or other shapes extending laterally and / or longitudinally. Figure 2 shows two examples of imaging devices 210 that may be used.

[0034] In some embodiments, the imaging device pocket 204 may be at least partially surrounded by the guide 205. In some embodiments, the guide 205 may be raised from the base layer 201 to form a wall around the imaging device pocket 204. The guide 205 facilitates controlled adjustment to the imaging device 210 when placed in the imaging device pocket 204 and can control the angle or rotation of the probe over multiple degrees of freedom (e.g., an ultrasound probe).

[0035] In some embodiments, the imaging device pocket 204 includes a gel cap, and the gel cap may be a disposable standalone device integrated into the fixed platform 200. In other embodiments, the gel cap is attached to the patient or imaging device 210 and is easily accessible for use within the imaging device pocket 204. In some embodiments, the gel cap is antimicrobial, thereby allowing the imaging device pocket 204 to remain clean through multiple uses of the imaging device 210. In some embodiments, the gel cap may be configured to be rehydrated, thereby allowing the gel cap to be reused multiple times within the imaging device pocket 204.

[0036] Figure 3 shows an example in which the fixed platform 200 is formed from two separate components 200a and 200b. Component 200a includes a vascular access device pocket 202 and a catheter insertion site window 203, while component 200b includes an imaging device pocket 204. This two-component configuration of the fixed platform 200 can be used to accommodate catheters 111 of different lengths, such as long peripheral venous catheters and midline catheters. In some embodiments, component 200b may have an extended base layer 201 to facilitate attachment of component 200b to the patient's skin.

[0037] Figure 3 also shows an example in which the fixing platform 200 includes a fixing dressing 300 positioned on the upper fixing platform 200 (in this case, the upper component 200a) to fix the vascular access device 100 in place relative to the fixing platform 200. The fixing dressing 300 may include a layer 301 which can be shaped and sized to match the proximal end of the fixing platform 200 (for example, to match the size and shape of component 200a). The layer 301 may include a transparent window 303 which aligns with / overlaps with the catheter insertion site window 203 to facilitate visibility of the insertion site. In some embodiments, the transparent window 303 may align with / overlap with at least a portion of the vascular access device pocket 202 to facilitate visibility of the catheter adapter 110. The layer 301 may also include a boundary 302. In some embodiments, the underside of the boundary 302 may include an adhesive for fixing the fixing dressing 300 to the fixing platform 200. In some embodiments, a slot 304 is formed in the boundary 302, allowing the extension set 114 to pass through the fixed dressing 300. Figure 4 is the same as Figure 3, but shows that component 200b may be oriented longitudinally with respect to the catheter 111.

[0038] In some embodiments, the fixed platform 200 may consist only of component 200b. In such embodiments, the fixed platform 200 may be appropriately positioned to ensure that the imaging device pocket 204 is above the distal tip of the catheter 111.

[0039] Figures 5A–5C show another example of a fixed platform 200 configured for use with vascular access devices 100 of different configurations, which are non-integrated vascular access devices. These figures illustrate how the size, shape, and relative position of the vascular access device pockets 202, catheter insertion site window 203, and imaging device pocket 204 of the fixed platform 200, as well as the transparent window 303 and slot 304 of the fixed dressing 300, may be configured to accommodate different vascular access devices.

[0040] Figure 6A shows an example of an imaging system 600 configured according to one or more embodiments of the present disclosure. The imaging system 600 includes one or more imaging devices 210, one or more base units 612, one or more monitoring devices 613, and a database 614. Each imaging device 210 can be used to capture images (e.g., via ultrasound, near-infrared, optical fluorescence, optical reflectivity, LiDAR, or other modalities) and, optionally, other vascular access data related to vascular access devices placed in the patient's blood vessels. In some embodiments, the imaging system 600 may include one or more Doppler devices that can be used to capture flow characteristics. Doppler devices can be used instead of or in addition to imaging devices and can provide functions such as those described below.

[0041] In some embodiments, a base unit 612, which may be integrated into another component of the imaging system 600, may represent a networking-enabled computing device configured to communicate with a database 614 and, optionally, a monitoring device 613. For example, in some embodiments, an imaging device 210 may interface directly with the base unit 612 (e.g., via Bluetooth® or another short-range communication protocol) to communicate vascular access data, which may then communicate with the database 614 to store such vascular access data and / or with the monitoring device 613 to display such vascular access data. In other embodiments, the imaging device 210 may have such networking capabilities and therefore may be considered to include the base unit 612.

[0042] The monitoring device 613 may be any computing device configured to display data related to the continuity of care. For example, the monitoring device 613 may be a personal computer, smartphone, or dedicated computing device / display, where a web-based interface or dedicated application is used to display vascular access data related to the continuity of care for the patient. Such a monitoring device 613 may be placed in the patient's room or nursing station and may be transported by a clinician or the like. In some embodiments, the monitoring device 613 may include a base unit 612. For example, the monitoring device 613 may be placed next to the patient and implement the functions of the base unit 612 to interface with the imaging device 210 and the database 614.

[0043] Database 614 is intended to represent any arrangement of computing components that may be used to store vascular access data for one or more patients. For example, database 614 may be a dedicated server computing device or cloud storage configured to implement database functionality.

[0044] Figure 6B is a flowchart representing continuity of care, in which embodiments enable the capture and continuity of vascular access data. Continuity of care may include continuing the patient's vascular access history. In other words, vascular access data related to previous vascular accesses can be acquired and such data can be connected through the continuity of care for subsequent vascular accesses. Continuity of care may also include collecting and / or connecting vascular access data during site assessment and vascular access device placement support. These steps may require using one or more imaging devices 210 to examine the location of the patient's veins both before and during vascular access device placement, to identify and select the optimal vein for placement, and to determine the appropriate catheter gauge size and length for the target vein. One or more imaging devices 210 can be used to generate and / or present vascular access data between these two steps of continuity of care. Continuity of care may further include collecting vascular access data in the form of an initial placement baseline record. This record may include the location of the vascular access device in the patient's vascular system, the extent to which the vascular access device is inserted into the patient's vascular system, and so on. Continuity of care may also include collecting vascular access data throughout the placement of the vascular access device, such as records representing the evaluation or monitoring of the patient and / or the vascular access device, including at the time of procedures, events, or other occurrences. Embodiments of this disclosure may be primarily beneficial for this stage. Continuity of care may further include collecting vascular access data constituting a record of the removal of the vascular access device. Finally, continuity of care may include collecting vascular access data in the form of vascular access experiences and electronic health record documents (e.g., feedback from the patient and / or one or more clinicians involved in the vascular access).

[0045] Figure 7A is a partial cross-sectional view of the patient's vascular system 701 when the fixed platform 200 is used. As shown, the imaging device pocket 204 is positioned above the distal tip 111a of the catheter 111. Thus, the clinician can position the head of the imaging device 210 within the imaging device pocket 204 to capture an image of the distal tip 111a. For example, Figure 7B is an image capturing a cross-sectional view of the vascular system 701, catheter 111, and distal tip 111a, and Figure 7C is an image capturing a cross-sectional view of the vascular system 701 and catheter 111. The guide 205 facilitates the proper positioning of the imaging device 210, allowing for the clear capture of such views.

[0046] Figure 8 shows an example of how images generated by the imaging device 210 can be integrated into a display along with various information derived from the images. As shown, this display may be generated and / or presented on the base unit 612 and / or any number of monitoring devices 613. This display may include one or more figures of the catheter 111 in the vascular system 701, such as the cross-sectional view in Figure 7B and the section-sectional view in Figure 7C. The cross-sectional view may allow a clinician to see how the catheter 111 extends into the vascular system 701 and thus facilitate a quick determination of whether the catheter 111 is fully inserted, whether the distal tip 111a is properly positioned, whether there is an occlusion, or whether there are any other conditions that can be detected via ultrasound or other modalities. The section-sectional view may allow a clinician to see how a particular portion of the catheter 111 is positioned within the vascular system 701 and thus facilitate a quick determination of whether the catheter 111 may be excessively restricting blood flow through the vascular system 701 or any other conditions that can be detected via ultrasound. In some embodiments, the size and shape of the imaging device window 204 can allow the user to adjust the position of the view generated by the imaging device 210. For example, the user can move the cross-sectional view along the length of the catheter 111 by sliding the imaging device 210 within the imaging device window 204 to determine whether there is excessive occlusion in any portion along the length of the catheter 111.

[0047] Figure 8 also shows that the display may include various vascular access data that can be derived from images or inputs generated by the imaging device 210. For example, the display may include an indicator 801a for the gauge of the catheter 111 and an indicator 801b for the length of the catheter 111. Indicators 801a and 801b may be obtained via user input or calculated from images generated by the imaging device 210.

[0048] The display also includes indicators 802a, 802b, and 802c for different parameters. In some embodiments, these parameters may be selectable. For example, in Figure 8, indicator 802a provides information about when the catheter 111 was last flushed. This last flush information can be calculated using an image generated by the imaging device 210. For example, Doppler technique can be applied to the image data to detect when fluid is flowing out through the distal tip 111a, and in response to such detection, the base unit 612 (or monitoring device 613) can automatically store an indication that a flush occurred at that point. In Figure 8, indicators 802b and 802c are not selected. However, these indicators and additional indicators can be selected to display information on any of many different conditions, events, statuses, etc., as described below.

[0049] The display further includes indicators 803a and 803b that provide information about the portion of the catheter 111 located inside the vascular system 701. Indicator 803a defines the catheter-to-vein ratio (i.e., the ratio of the diameter of the catheter to the diameter of the vein at a particular location). Indicator 803b defines the gripping state of the catheter 111 (i.e., the length of the catheter 111 inside the vascular system 701, or the proportion of the catheter length inside the vascular system). The display further includes indicator 804 that defines the patency state of the catheter 111 (i.e., whether the catheter 111 can remain safely within the vascular system 701). The base unit 612 (or monitoring device 613) can calculate the patency state using images provided by the imaging device 210 (for example, to detect the extent to which the catheter 111 and / or the vascular system 701 around the catheter 111 may be blocked).

[0050] As suggested above, the imaging system 600 may be configured to monitor and / or display information regarding the condition of the catheter 111, the vascular system 701, or the surrounding tissue, and various related physiological or procedural parameters by utilizing the images provided by the imaging device 210. This information includes catheter shape information (e.g., catheter-to-vein ratio, catheter gripping state, blood flow restriction 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, valve, bifurcation or other physiological features), catheter movement or displacement, catheter twisting, detachment events, extravasation, infiltration detection (e.g., by monitoring the perivascular system 501), thrombus formation, phlebitis (visual or correlated cumulative motion), patency indicators, blood flow characteristics (e.g., by detecting the velocity and / or volume of blood flowing into the catheter 102 using Doppler), fluid administration flow characteristics (e.g., by detecting the velocity, volume, direction, and / or duration of the fluid using Doppler), procedure events (e.g., flush, draw, fluid administration), and / or the position of the probe or sensor relative to the vein or line tip of the line draw tube, catheter, or physiological features (e.g., thrombus, valve, wall, bifurcation, etc.).

[0051] The imaging system 600 may provide a display containing an indicator of any of the above information and may provide corresponding alerts. For example, the base unit 612 or monitoring device 613 may be configured to output visual, audible, tactile, or digital alerts when a condition or event is detected from the ultrasound image.

[0052] Figure 9 shows an example of how the base unit 612 (or possibly the monitoring device 613) may be configured to generate display content from images generated by the imaging device 210. This display content may include any of the above information, indicators, status, events, alerts, etc. (collectively, “parameters”). Figure 8 is an example of display content.

[0053] The base unit 612 may be configured to receive images from the imaging device 210 continuously, periodically, on demand, etc. The base unit 612 may include an image processor 612a configured to process images and generate processed image data. This processed image data may be input to an artificial intelligence engine 612b, which may be configured to detect and / or generate parameters from the processed image data. The parameters along with the images may be provided to a display module 612c, which can generate display content including the images and parameters.

[0054] In some embodiments, the image processor 612a may be configured to determine various status information, such as catheter shape or position information, or the presence of thrombus, torsion, or other occlusion, from an image or sequence of images. In some embodiments, the artificial intelligence engine 612b may be trained to detect when parameters are present in the stream of images. For example, the artificial intelligence engine 612b may detect when a sequence of images indicates a flash event, draw event, extravasation, movement, or motion event. In some embodiments, the artificial intelligence engine 612b can be used to predict the occurrence or increased risk of potential complications or events. For example, the artificial intelligence engine 612b may process images to detect changes or deteriorations in the catheter's grip over time. If this trend is detected, or when a predetermined grip threshold is reached (e.g., less than a predetermined percentage of the catheter length remains in the vein), the artificial intelligence engine 612b may trigger an alert so that a clinician can prevent catheter malfunction.

[0055] In some embodiments, an artificial intelligence engine 612b (or another artificial intelligence solution) can be used to automatically detect the depth of the distal tip 111a from the image generated by the imaging device 210. The detected depth can then be used to improve the accuracy of the image. For example, to facilitate the use of C-mode ultrasound, the imaging device 210 can generate images at a preset depth, and then the artificial intelligence engine 612b can evaluate the images to identify which images contain the catheter 111. The known depth of the identified images can then be used as the depth for generating further C-mode ultrasound images.

[0056] All examples and conditional statements set forth herein are intended for educational purposes to facilitate the Art and to help the reader understand the Invention and the concepts provided by the Inventors, and should be construed as not being limited to the examples and conditions specifically listed herein. While embodiments of the Invention are 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. Base layer and A vascular access device pocket formed in the base layer, A catheter insertion site window formed in the base layer distal to the vascular access device pocket, Imaging device pocket, A fixed platform equipped with these features.

2. The fixing platform according to claim 1, wherein the vascular access device pocket is shaped and sized to correspond to the stabilization platform of the vascular access device.

3. The fixed platform according to claim 1, wherein the vascular access device pocket is a notch in the base layer.

4. The fixation platform according to claim 1, wherein the vascular access device pocket comprises an adhesive portion on the upper surface of the base layer.

5. The fixed platform according to claim 1, wherein the catheter insertion site window overlaps with the vascular access device pocket.

6. The fixed platform according to claim 1, wherein the catheter insertion site window is spaced apart from the vascular access device pocket.

7. The fixed platform according to claim 1, wherein the imaging device pocket is formed within the base layer.

8. The fixed platform according to claim 7, wherein the base layer is formed as a component separate from the vascular access device pocket and the catheter insertion site window.

9. A guide that at least partially surrounds the imaging device pocket, A fixed platform according to claim 1, further comprising the above.

10. The fixed platform according to claim 9, wherein the guide extends over the base layer.

11. The immobilization platform according to claim 1, wherein the imaging device pocket includes a gel cap.

12. The fixing platform according to claim 1, further comprising a fixing dressing configured to be positioned on top of at least a portion of the fixing platform, wherein the fixing dressing has a transparent window positioned on top of the catheter insertion site window.

13. An ultrasound imaging device configured to acquire images of one or more catheters inserted into a patient's vascular system, The ultrasound imaging device is positioned on the distal tip of the catheter inserted into the patient's vascular system, and the base unit is configured to receive the image from the ultrasound imaging device. An imaging system equipped with the following features.

14. A fixing platform further comprising a base layer, a vascular access device pocket formed in the base layer, a catheter insertion site window formed in the base layer distal to the vascular access device pocket, and an imaging device pocket, The imaging system according to claim 13, wherein the base unit is configured to receive the image from the ultrasound imaging device located within the ultrasound imaging device pocket when the ultrasound imaging device pocket is positioned above the distal end of the catheter inserted into the patient's vascular system.

15. The imaging system according to claim 13, wherein the base unit includes an artificial intelligence engine configured to detect the depth of the distal tip of the catheter from the image.

16. The system further comprises a display for displaying the aforementioned image, The imaging system according to claim 13, wherein the image includes a cross-sectional view of the catheter and a cross-sectional view of the catheter.

17. The imaging system according to claim 14, wherein the fixed platform comprises a first component including the vascular access device pocket and the catheter insertion site window, and a second component including the imaging device pocket.

18. A vascular access device having a stabilization platform, further comprising: The imaging system according to claim 14, wherein the vascular access device pocket is configured to receive the stabilization platform.

19. A method for obtaining images of a patient's vascular system, The steps include positioning an ultrasound imaging device to acquire images of one or more catheters inserted into the patient's vascular system, The steps include displaying one or more images of the catheter so that a clinician can view the catheter inserted into the vascular system of the patient, Methods that include...

20. The further step includes placing a fixed platform on the patient, The fixation platform includes an imaging device pocket positioned above the catheter inserted into the patient's vascular system, The method according to claim 19, wherein the fixed platform further comprises a base layer, a vascular access device pocket formed within the base layer, and a catheter insertion site window formed within the base layer distal to the vascular access device pocket.

Images