Collection and integration of vascular access data throughout the continuity of care.

Abstract

A system and method are provided for collecting and linking vascular access data throughout the continuity of vascular access care. Patient historical vascular access data is stored and made accessible during subsequent attempts to access the patient's vascular system. Additional vascular access data is generated and stored during subsequent attempts to access the patient's vascular system. By collecting and linking vascular access data, clinicians can ensure success throughout the continuity of vascular access care.

Description

Technical Field

[0001] The present disclosure relates to the collection and coordination of vascular access data across the continuum of care.

Background Art

[0002] Catheters are widely used in various infusion therapies. For example, a catheter can be used to inject therapeutic agents or fluids 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 type of catheter device is an over-the-needle type catheter. As its 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 projects 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 positioned 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 length of time a 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, and loss of patency.

[0005] 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]

[0006] This disclosure generally relates to a system and method for collecting and linking vascular access data throughout the continuity of vascular access care. Patient historical vascular access data is stored and made accessible during subsequent attempts to access the patient's vascular system. Additional vascular access data is generated and stored during subsequent attempts to access the patient's vascular system. By collecting and linking vascular access data, clinicians can succeed throughout the continuity of vascular access care.

[0007] In some embodiments, this may include collecting and linking vascular access data, storing historical vascular access data representing a patient's vascular access history, presenting the historical vascular access data during access to the patient's vascular system, collecting additional vascular access data during access to the patient's vascular system, and storing the additional vascular access data together with the historical vascular access data.

[0008] In some embodiments, the historical vascular access data may include one or more images of the patient's vascular system.

[0009] In some embodiments, the additional vascular access data may include one or more images of the patient's vascular system.

[0010] In some embodiments, presenting the historical vascular access data during access to the patient's vascular system may include presenting the historical vascular access data during site assessment prior to placement of the vascular access device in the patient's vascular system, or while performing placement support during placement of the vascular access device in the patient's vascular system.

[0011] In some embodiments, collecting additional vascular access data during access to the patient's vascular system may include collecting such additional vascular access data during the site assessment or during the execution of placement support.

[0012] In some embodiments, the additional vascular access data collected during access to the patient's vascular system may include baseline documentation of the initial placement state.

[0013] In some embodiments, collecting additional vascular access data during access to the patient's vascular system may include collecting such additional vascular access data during the implantation of a vascular access device.

[0014] In some embodiments, the method may further include processing the additional vascular access data to generate one or more alerts, conditions, or reports.

[0015] In some embodiments, the one or more warnings, conditions, or reports may be generated during the implantation of a vascular access device used to access the patient's vascular system.

[0016] In some embodiments, the additional vascular access data collected during the patient's vascular access may identify the removal of the vascular access device used to access the patient's vascular system.

[0017] In some embodiments, methods for collecting and coordinating vascular access data throughout the continuity of care may include: storing historical vascular access data representing the patient's history of vascular access; presenting the historical vascular access data during access to the patient's vascular system; collecting vascular access data during site assessment or while supporting the placement of access to the patient's vascular system; collecting vascular access data representing baseline documentation of the initial state of placement of access to the patient's vascular system; and collecting vascular access data during the placement of vascular access devices used to access the patient's vascular system.

[0018] In some embodiments, the method may further include collecting vascular access data representing the removal of the vascular access device.

[0019] In some embodiments, the method may further include collecting vascular access data representing the patient's experience of accessing the vascular system.

[0020] In some embodiments, the vascular access device includes a catheter, and the vascular access data collected during the placement of the vascular access device used to access the patient's vascular system may represent one or more of the following: catheter movement or displacement, catheter twisting, dislodgement events, extravasation, infiltration, thrombus formation, phlebitis, patency indicators, blood flow characteristics, fluid administration flow rate characteristics, procedure events, or line draw tube, probe or sensor position.

[0021] In some embodiments, the method may further include processing the vascular access data to automatically detect treatment events.

[0022] In some embodiments, a system for collecting and coordinating vascular access data throughout the continuity of care may include: a database storing historical vascular access data representing a patient's history of vascular access; one or more monitoring devices configured to present the historical vascular access data during access to the patient's vascular system; and one or more imaging devices configured to generate additional vascular access data during access to the patient's vascular system and to store the additional vascular access data in the database in association with the historical vascular access data.

[0023] In some embodiments, the system may further include one or more Doppler devices configured to generate additional vascular access data during access to the patient's vascular system and to store the additional vascular access data in the database in association with the historical vascular access data and the additional vascular access data.

[0024] In some embodiments, the one or more imaging devices may be configured to generate the additional vascular access data during site assessment or during placement support for access to the patient's vascular system.

[0025] In some embodiments, the one or more imaging devices may be configured to generate the additional vascular access data during the placement of a vascular access device used to access the patient's vascular system.

[0026] In some embodiments, the one or more monitoring devices may be configured to present the historical vascular access data during site assessment or during placement support for access to the patient's vascular system.

[0027] 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. Also, it should be understood that without departing from the scope of the various embodiments of the present invention, embodiments can be combined, other embodiments can be utilized, and structural changes not described in the claims can be made. Therefore, the following detailed description should not be taken in a limiting sense. **Brief Description of the Drawings**

[0028] Exemplary embodiments are described and detailed further through the use of the accompanying drawings.

[0029] [Figure 1A] FIG. 1A is a diagram showing an exemplary computing environment in which an embodiment can be implemented. [Figure 1B] FIG. 1B is a flowchart depicting the continuity of care associated with vascular access. [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 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 is inserted that can be generated by a vascular access device configured according to one or more embodiments. [Figure 3C] FIG. 3C is a cross-sectional view of a vein into which a catheter is inserted that can be generated by a vascular access device configured according to one or more embodiments. [Figure 4]Figure 4 shows an exemplary representation that may be generated by a vascular access system configured according to one or more embodiments. [Figure 5] Figure 5 is a diagram providing examples of electronic components that may be included in one or more embodiments of a vascular access system base unit or monitoring device. [Figure 6A] Figure 6A provides an example of how vascular access data can be collected and integrated throughout the continuity of care. [Figure 6B] Figure 6B provides an example of how vascular access data can be collected and integrated throughout the continuity of care. [Figure 6C] Figure 6C provides an example of how vascular access data can be collected and integrated throughout the continuity of care. [Figure 6D] Figure 6D provides an example of how vascular access data can be collected and integrated throughout the continuity of care. [Figure 6E] Figure 6E provides an example of how vascular access data can be collected and integrated throughout the continuity of care. [Figure 6F] Figure 6F provides an example of how vascular access data can be collected and integrated throughout the continuity of care. [Figure 6G] Figure 6G provides an example of how vascular access data can be collected and integrated throughout the continuity of care. [Figure 7] Figure 7 is a diagram that provides an example of how vascular access data can be processed. [Modes for carrying out the invention]

[0030] 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 venous catheter devices and other devices that can access the patient’s vascular system. “Vascular access data” should be interpreted to include all data relating to access to the 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 placement and / or removal of the vascular access device, information regarding events that occurred during placement of the vascular access device, detected complications, patient vital signs, fluid and blood flow characteristics, etc.

[0031] Figure 1A shows an example of a computing environment 10 in which one or more embodiments may be implemented. The computing environment 10 includes one or more imaging devices 11, one or more base units 12, one or more monitoring devices 13, and a database. Each imaging device 11 can be used to capture images (e.g., via ultrasound or other modalities) and optionally other vascular access data in relation to a vascular access device placed in a patient's blood vessel. Examples of imaging devices 11 include a standalone imaging device used for ultrasound-guided venous access, and an ultrasound assembly integrated into a vascular access device, such as an ultrasound assembly 200, which will be described later with reference to Figures 2A-5. In some embodiments, the computing environment 10 may include one or more Doppler devices that can be used to capture blood flow characteristics. The Doppler devices can be used instead of or in addition to imaging devices to provide the functions described later.

[0032] In some embodiments, the base unit 12, which can be integrated into another component of the computing environment 10, may represent a network-enabled computing device configured to communicate with a database 14 and optionally a monitoring device 13. For example, in some embodiments, the imaging device 11 may interface directly with the base unit 12 to communicate vascular access data (e.g., via Bluetooth® or another short-range communication protocol), communicate the vascular access data, and then communicate with a database 14 for storing such vascular access data and / or a monitoring device 13 for displaying such vascular access data. In other embodiments, the imaging device 11 may have such networking capabilities and therefore be considered to include the base unit 12.

[0033] The monitoring device 13 can be any computing device configured to display data related to the continuity of care. For example, the monitoring device 13 may be a personal computer, a smartphone, or a dedicated computing device / display, and can display vascular access data related to the continuity of care for the patient using a web-based interface or a dedicated application. Such a monitoring device 13 can be installed in the patient's room or nursing station, or carried by a clinician. In some embodiments, the monitoring device 13 may include a base unit 12. For example, the monitoring device 13 may be placed next to the patient and perform the functions of the base unit 12, and can interface with an imaging device 11 and a database 14.

[0034] Database 14 is intended to present any arrangement of computing components that may be used to store vascular access data for one or more patients. For example, Database 14 may be a dedicated server computing device or cloud storage configured to perform database functions.

[0035] Figure 1B is a flowchart illustrating continuity of care throughout the entire process, enabling the embodiment to capture and link vascular access data. Continuity of care includes linking the patient's vascular access history. In other words, vascular access data related to previous vascular accesses can be acquired and such data linked throughout the continuity of care for subsequent vascular accesses. Continuity of care also includes collecting and / or linking vascular access data during site assessment and vascular access device (VAD) placement support. These stages may require using one or more imaging devices 11 before and during vascular access device placement to examine the patient's vein location, identify and select the most suitable vein for placement, and determine the appropriate catheter gauge size and length for the target vein. One or more imaging devices 11 can be used to generate and / or present vascular access data in these two stages of continuity of care. Continuity of care may further include collecting vascular access data in the form of baseline documentation of the initial placement state. This documentation may include the location of the vascular access device within 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 documentation representing the evaluation or monitoring of the patient and / or the vascular access device, including during procedures, events, or other occurrences. Continuity of care may further include collecting vascular access data that constitutes documentation regarding the removal of the vascular access device. Finally, continuity of care may include collecting vascular access data in the form of vascular access experience and electronic health record documentation (e.g., feedback from the patient and / or one or more clinicians involved in the vascular access).

[0036] Before detailing how computing environment 10 is used to collect and integrate vascular access data throughout the continuity of care, we will describe some examples of dedicated imaging devices 11 that can be used for this purpose. Figures 2A–5 show these examples.

[0037] Referring here to Figure 2A, the vascular access system 50 may include a vascular access device 100, an ultrasound assembly 200 (an example of an imaging device 11 including a base unit 12), a fixation dressing 300, and one or more monitoring devices 13. 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.

[0038] The ultrasound assembly 200 may include an ultrasound probe 201 (or patch) (an example of an imaging device 11), 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, and a base unit 12 to which the cable 204 can be connected to enable communication between the base unit 12 and the ultrasound probe 201. 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. As suggested above, the base unit 12 may be any device including a circuit for communicating with the ultrasound probe 201. In some embodiments, the base unit 12 may supply power to the ultrasound probe 201. In some embodiments, the base unit 12 may directly process images received from the ultrasound probe 201, while in other embodiments, the base unit 12 may receive images from the ultrasound probe 201 and transfer those images to another device (e.g., a monitoring device 13) for processing. In some embodiments, the base unit 12 may include user input elements to allow a user (e.g., a clinician and / or patient) to control the ultrasound probe 201. In some embodiments, the base unit 12 may be connected to one or more other devices to allow users of one or more other devices (e.g., a monitoring device 13) to control the ultrasound probe 201.

[0039] The fixation dressing 300 may be sized and shaped to cover and fix the ultrasound probe 201 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 placed on 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.

[0040] 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 and the catheter adapter 101. In any case, the ultrasound probe 201 may be positioned on the patient's skin so as to be positioned above the distal end of the catheter 102 when the catheter 102 is inserted into the patient's vascular system.

[0041] As suggested above, the monitoring device 13 can represent any device having a display capable of displaying images generated by the ultrasound probe 201 and / or information obtained from such images. Examples of monitoring devices 13 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 13 may function as a base unit 12. The monitoring device 13 may also be configured to interface with one or more separate computing systems, such as a system for storing vascular access data in a database 14.

[0042] 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 to the base unit 12 or, optionally, to a monitoring device 13. The wireless adapter 206 may also include a battery to power the ultrasound probe 201. 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.

[0043] Figures 2A and 2B 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.

[0044] 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. By placing a fixation dressing 300 on the catheter adapter 101 and the ultrasound probe 201, the ultrasound probe 201 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, and by events that trigger image acquisition, 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.

[0045] Figure 4 provides an example of how images generated by the ultrasound probe 201 are integrated into a display along with various information derived from the images. As shown, this display can be generated and / or presented on the base unit 12 and / or any number of monitoring devices 13. 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.

[0046] Figure 4 also shows that the display may include images generated by the ultrasound probe 201 or various vascular access data obtained from input. For example, the display may include indicator 601a showing the gauge of catheter 102 and indicator 601b showing the length of catheter 102. Indicators 601a and 601b can be obtained from user input or calculated from images generated by the ultrasound probe 201.

[0047] The display also includes indicators 602a, 602b, and 602c that show various parameters. In some embodiments, these parameters can be selected. 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 images 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 12 (or monitoring device 13) automatically stores information indicating that a flush occurred at that time. In Figure 4, indicators 602b and 602c are not selected. However, these indicators and additional indicators can be selected to display various states, events, statuses, and other information, as described below.

[0048] The display further includes indicators 603a and 603b that provide information about the portion of 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 catheter 102 (i.e., the length of catheter 102 within the vascular system 501, or the proportion of the catheter length within the vascular system). The display further includes indicator 604 that defines the patency status of catheter 102 (i.e., whether catheter 102 can remain safely within the vascular system 501). The base unit 12 (or monitoring device 13) can calculate the patency status using images provided by the ultrasound probe 201 (e.g., by detecting the extent to which catheter 102 and / or the vascular system 501 surrounding catheter 102 are occluded).

[0049] As suggested above, the vascular access system 50 can be configured to utilize images provided by the ultrasound probe 201 to monitor and / or display information regarding the condition of the catheter 102, the vascular system 501, or the surrounding tissue, as well as various related physiological or procedural parameters. 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 displacement, catheter twisting, detachment 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 physiological features (thrombus, valve, wall, branch, etc.).

[0050] 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 12 or monitoring device 13 may be configured to output a visual, auditory, tactile, or digital warning when a condition or event is detected from the ultrasound image. In some embodiments, the ultrasound probe 201, electrical adapter 203, cable 204, and / or wireless adapter 206 may include one or more warning mechanisms (e.g., LEDs, speakers, tactile units, etc.) for providing warnings.

[0051] Figure 5 provides an example of how the base unit 12 (or possibly the monitoring device 13) is configured to generate display content from ultrasound images. 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.

[0052] The base unit 12 may be configured to receive ultrasound images from the ultrasound probe 201 continuously, periodically, on demand, etc. The base unit 12 may include an image processor 12a configured to process the ultrasound images and generate processed image data. This processed image data can be input to an artificial intelligence engine 12b, which may be configured to detect and / or generate parameters from the processed image data. The parameters, along with the ultrasound images, may be provided to a display module 12c, which may generate display content including the images and parameters.

[0053] In some embodiments, the image processor 12a 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 12b may be trained to detect the presence of parameters within a stream of ultrasound images. For example, the artificial intelligence engine 12b may detect when a sequence of ultrasound images indicates a flash event, a draw event, the occurrence of extravasation, detachment, or displacement event. In some embodiments, the artificial intelligence engine 12b can be used to predict the occurrence or increased risk of potential complications or events. For example, the artificial intelligence engine 12b may process ultrasound images to detect that the length of the catheter is changing or decreasing over time. If this trend is detected, or if a threshold length is reached (e.g., when the length of the catheter falls below a certain percentage within the vein), the artificial intelligence engine 12b may trigger a warning so that the clinician can prevent catheter failure.

[0054] Figures 6A–6G provide examples of how vascular access data is collected and integrated throughout the continuity of care. Figure 6A assumes that a clinician is about to insert a vascular access device into a patient's vascular system. As part of pre-insertion planning, the clinician may use a monitoring device 13 to request the patient's vascular access data history. In step 1b, the monitoring device 13 can interface with a database 14 to retrieve the patient's vascular access data history. For example, the monitoring device 13 can use a patient identifier to query the database 14 for vascular access data associated with the patient.

[0055] Referring to Figure 6B, in step 2, the clinician can review the patient's vascular access data history on the monitoring device 13. For example, the patient's vascular access data history may include vascular access data collected during previous vascular accesses, and may identify placement time, placement location (e.g., which part of the body, which vein, etc.), removal time, events, problems, images, etc., which will be described in more detail below. By reviewing this vascular access data history, the clinician can gain more information and place the vascular access device more appropriately (e.g., avoid placement locations where previous access attempts failed and / or where many problems occurred).

[0056] Referring to Figure 6C, in step 3a, after / while considering the patient's vascular access data history, the clinician may use the imaging device 11 to perform site assessment and / or placement support during the placement of the vascular access device. For example, the clinician may use the monitoring device 13 to view images or information about previous placements included in the patient's vascular access data history, and while using the imaging device 11, review that images or information to identify suitable locations for inserting the vascular access device. In some embodiments, in step 3b, the imaging device 11 may generate vascular access data relating to site assessment and / or placement support for the vascular access device and transmit it to the database 14.

[0057] Referring to Figure 6D, it is assumed that a clinician has placed a vascular access device in the patient's vascular system. In step 4, the imaging device 11 can generate vascular access data representing baseline documentation of the initial placement state, which can then be stored in the database 14 (e.g., via the base unit 12). In the illustrated embodiment, it is assumed that the imaging device 11, similar to the ultrasound assembly 200, is used as part of the vascular access and can therefore continuously generate vascular access data throughout the placement of the vascular access device.

[0058] Baseline documentation of the initial placement state can identify geometric and / or positional information of the vascular access device within the patient's vascular system. For example, this documentation can define the ratio of catheter to vein, catheter length, axial position of the catheter, position or angle of the catheter tip relative to the vascular wall, valves, branches, etc., and blood flow restriction. In short, this baseline documentation can identify where the catheter is initially placed within the vascular system.

[0059] Referring to Figure 6E, in step 5a, the imaging device 11 may generate vascular access data throughout the placement of the vascular access device, and this data may be stored in the database 14. Similarly, in step 5b, the imaging device 11 may make such data available on the monitoring device 13. If the imaging device 11 is integrated with the vascular access device as well as the ultrasound assembly 200, steps 5a and / or 5b can be performed sequentially and automatically. However, if the imaging device 11 is a separate component, a clinician may periodically use the imaging device to generate vascular access data.

[0060] During the placement of a vascular access device, a wide variety of vascular access data can be collected. For example, this vascular access data can represent catheter movement and displacement, catheter twisting, dislodgement events, extravasation, infiltration, thrombus formation, phlebitis (e.g., visual or correlated cumulative movement), patency indicators, intravenous or aspiration or blood sampling blood flow characteristics (e.g., velocity, volume, direction, Doppler measurement, etc.), fluid administration flow characteristics (e.g., velocity, volume, direction, duration, etc.), procedure events (e.g., flushing, drawing, fluid administration, etc.), line draw tube, position of probe or sensor relative to the intravenous or catheter tip, or physiological features (e.g., thrombus, valve, wall, branch, etc.) (e.g., as images and / or data). In some embodiments, procedure events can be detected automatically (e.g., using artificial intelligence and / or image processing as shown in Figure 7 below) or manually (e.g., via clinician input to image device 11 and / or monitoring device 13).

[0061] Referring to Figure 6F, step 6a assumes that a clinician removes the vascular access device from the patient's vascular system. In step 6b, the imaging device 11 can automatically generate vascular access data indicating the removal (e.g., removal time, reason for removal, etc.) and store it in the database 14. Alternatively, in some embodiments, the clinician may manually generate vascular access data indicating the removal using the imaging device 11 and / or the monitoring device 13.

[0062] Referring to Figure 6G, in step 7, the clinician may enter additional vascular access data (e.g., into monitoring device 13) in the form of documentation of vascular access experience or other documentation related to the patient's electronic health record. At this point, database 14 can hold vascular access data regarding the continuity of vascular access care, and this data may become part of the patient's vascular access data history.

[0063] In summary, the processing shown in Figures 6A–6G demonstrates that historical vascular access data can be acquired and presented to the clinician throughout the entire continuity of care, and current vascular access data can be generated and collected throughout the entire continuity of care. The embodiment allows all of this vascular access data to be considered collectively at any point in the continuity of care.

[0064] In some embodiments, the vascular access data stored in the database 14 can be processed to generate warnings, statuses, reports, etc. Such processing can be performed during vascular access (e.g., in real time) or after vascular access (e.g., to perform a diagnosis, as part of a study, etc.). Figure 7 provides an example in which the vascular access data processor 700 interfaces with the database 14 to acquire and process vascular access data and generates warnings, statuses, reports, etc., which can be presented via the monitoring device 13 and / or stored in the database 14. The vascular access data processor 700 may use various algorithms, artificial intelligence, or other processing techniques for this purpose. In some embodiments, the vascular access data processor 700 may be a standalone computing device, and in other embodiments, the vascular access data processor 700 may be integrated into the imaging device 11 or the monitoring device 13.

[0065] 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. A method for collecting and linking vascular access data, This involves storing historical vascular access data that represents the patient's vascular access history, Presenting the historical vascular access data during access to the patient's vascular system, Collecting additional vascular access data during access to the patient's vascular system, The additional vascular access data is stored together with the historical vascular access data, A method that includes this.

2. The aforementioned historical vascular access data includes one or more images of the patient's vascular system. The method according to claim 1.

3. The aforementioned additional vascular access data includes one or more images of the patient's vascular system. The method according to claim 1.

4. Presenting the historical vascular access data during access to the patient's vascular system includes presenting the historical vascular access data during site assessment prior to placement of the vascular access device in the patient's vascular system, or while performing placement support during placement of the vascular access device in the patient's vascular system. The method according to claim 1.

5. Collecting additional vascular access data during access to the patient's vascular system includes collecting such additional vascular access data during the site assessment or during the execution of the placement support. The method according to claim 4.

6. The additional vascular access data collected during access to the patient's vascular system includes baseline documentation of the initial placement state. The method according to claim 1.

7. Collecting additional vascular access data during access to the patient's vascular system includes collecting such additional vascular access data during the implantation of a vascular access device. The method according to claim 1.

8. The method according to claim 7, further comprising processing the additional vascular access data to generate one or more warnings, conditions, or reports.

9. The one or more warnings, conditions, or reports mentioned above are generated during the implantation of a vascular access device used to access the patient's vascular system. The method according to claim 8.

10. The additional vascular access data collected during the patient's vascular access identifies the removal of the vascular access device used to access the patient's vascular system. The method according to claim 1.

11. A method for collecting and linking vascular access data throughout the continuity of care, This involves storing historical vascular access data that represents the patient's vascular access history, Presenting the historical vascular access data during access to the patient's vascular system, During site assessment, or while supporting the placement of access to the patient's vascular system, collect vascular access data, To collect vascular access data representing the baseline documentation of the initial state of access to the patient's vascular system, To collect vascular access data during the implantation of a vascular access device used to access the vascular system of the aforementioned patient, A method that includes this.

12. The method according to claim 11, further comprising collecting vascular access data representing the removal of the vascular access device.

13. The method according to claim 12, further comprising collecting vascular access data representing the patient's experience of accessing the vascular system.

14. The vascular access device includes a catheter, and the vascular access data collected during the placement of the vascular access device used to access the patient's vascular system represents one or more of the following: catheter movement or displacement, catheter twisting, dislodgement events, extravasation, infiltration, thrombus formation, phlebitis, patency indicators, blood flow characteristics, fluid administration flow rate characteristics, procedure events, or line draw tube, probe or sensor position. The method according to claim 11.

15. The method according to claim 14, further comprising processing the vascular access data to automatically detect a treatment event.

16. A system for collecting and linking vascular access data throughout the entire continuity of care, A database that stores historical vascular access data representing the patient's vascular access history, One or more monitoring devices configured to present the historical vascular access data during access to the patient's vascular system, One or more imaging devices configured to generate additional vascular access data during access to the patient's vascular system and to store the additional vascular access data in the database in association with the historical vascular access data, A system that includes this.

17. The system according to claim 16, further comprising one or more Doppler devices configured to generate additional vascular access data during access to the patient’s vascular system, and to store the additional vascular access data in a database in association with the historical vascular access data and the additional vascular access data.

18. The one or more imaging devices are configured to generate the additional vascular access data during site evaluation or during placement support for access to the patient's vascular system. The system according to claim 16.

19. The one or more imaging devices are configured to generate the additional vascular access data during the implantation of a vascular access device used to access the patient's vascular system. The system according to claim 16.

20. The one or more monitoring devices are configured to present the historical vascular access data during site assessment or during placement support for access to the patient's vascular system. The system according to claim 16.

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