Vascular access devices are commonly used for a variety of infusion therapies. For example, vascular access devices may be used for infusing therapeutic agents or fluids into a patient. Vascular access devices may also be used for withdrawing blood from the patient. There are a variety of vascular access devices commonly used in a medical setting, including, for example, peripherally-inserted central catheters, midline catheters, central venous catheters, dialysis catheters, and arterial catheters.
A common type of vascular access device includes a catheter that is over-the-needle. As its name implies, the catheter that is over-the-needle may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient. To verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the catheter may be left in place for future blood withdrawal or fluid infusion.
Although catheter indwell performance (i.e., how long the catheter can be safely left in the vasculature) has improved in recent years, there remains a significant number of complications that may develop throughout the intended dwell time of a vascular access device. These complications may include infiltration, extravasation, dislodgement, occlusion, loss of patency, infection, catheter kinking, catheter movement, thrombus development, and phlebitis. These complications may also include localized changes in a patient's physiology, such as vein or arterial size, collapse, stiffening, damage, and other changes that may accelerate further development of complications.
The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.
The present disclosure relates generally to imaging systems and methods for integrated vascular access device indwell assessment and data integration. Such imaging systems and methods can be used to better assess and monitor the status of an indwelling integrated vascular access device and the overall viability of the vascular access in the acute care and alternate site setting and to reduce the patient complications and experience, clinician burden, and overall effectiveness of the patient's treatment and care. Such imaging systems and methods can also facilitate the use of imaging devices, such as ultrasound devices, to assess the current state of an indwelling vascular access device and compare it to a prior state or established clinical standard. This may facilitate predictive detection, identification, and/or diagnosis of an emerging risk of a catheter related complication or detection of an actual complication intermittently and consistently.
Embodiments of the present disclosure may be implemented as a securement platform that includes 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.
In some embodiments, the vascular access device pocket may be shaped and sized to correspond with a stabilization platform of a vascular access device.
In some embodiments, the vascular access device pocket may be a cutout in the base layer.
In some embodiments, the vascular access device pocket may include an adhesive portion of an upper surface of the base layer.
In some embodiments, the catheter insertion site window may overlap with the vascular access device pocket.
In some embodiments, the catheter insertion site window may be spaced from the vascular access device pocket.
In some embodiments, the imaging device pocket may be formed in the base layer.
In some embodiments, the base layer may be formed in a separate component from the vascular access device pocket and the catheter insertion site window.
In some embodiments, the securement platform may include a guide that at least partially surrounds the imaging device pocket.
In some embodiments, the guide may extend above the base layer.
In some embodiments, the imaging device pocket may include a gel cap.
In some embodiments, the securement platform may include a securement dressing that is configured to be positioned overtop at least a portion of the securement platform. The securement dressing may have a transparent window that is positioned overtop the catheter insertion site window.
Embodiments of the present disclosure may be implemented as an imaging system that includes a securement platform and a base unit. The securement 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 positioned within the imaging device pocket when the imaging device pocket is positioned overtop a distal tip of a catheter that is inserted into a patient's vasculature.
In some embodiments, the base unit may include an artificial intelligence engine that is configured to detect a depth of the distal tip of the catheter from the images.
In some embodiments, the imaging system may include one or more monitoring devices for displaying display content derived from the images.
In some embodiments, the securement platform may include a securement dressing.
In some embodiments, the securement platform may include a first component that includes the vascular access device pocket and the catheter insertion site window and a second component that includes the imaging device pocket.
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.
Embodiments of the present disclosure may be implemented as a method for obtaining images of a patient's vasculature. A securement platform may be positioned on a patient. The securement platform may include an imaging device pocket. The imaging device pocket can be positioned overtop a catheter that is inserted through the patient's vasculature. An imaging device can be positioned in the imaging device pocket to obtain one or more images of the catheter.
In some embodiments, the securement 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.
It is to be understood that both the foregoing general description and the following detailed description are examples 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 instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.
Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
In this specification and the claims, the term “continuity of care” is intended to represent the entire duration of a vascular access including pre-insertion, during insertion, indwell duration, and post-removal. A “vascular access device” should be construed as encompassing an intravenous catheter device and any other device by which a patient's vasculature may be accessed. “Vascular access data” should be construed as encompassing any data relating to the access of a patient's vasculature using a vascular access device and includes images of the patient's vasculature, characteristics of the vascular access device, information about the placement and/or removal of the vascular access device, information about events that occur during the indwell of the vascular access device, complications detected, the patient's vitals, fluid and blood flow characteristics, etc.
Securement platform 200 can also include a catheter insertion site window 203 that is positioned distal to vascular access device pocket 202 to allow catheter 111 to pass through securement platform 200 and into the patient's vasculature when catheter adapter 110 is positioned above securement platform 200. In some embodiments, catheter insertion site window 203 may be shaped and sized to accommodate antimicrobial patches or pads or to enable the application and containment of skin adhesive for sealing the insertion site. In some embodiments, a slot (not shown) may be formed in base layer 201 and may extend between catheter insertion site window 203 and the periphery of base layer 201 to enable securement platform 200 to be placed under vascular access device 100 after insertion of catheter 111.
Securement platform 200 also includes an imaging device pocket 204 that is positioned distal to catheter insertion site window 203. Imaging device pocket 204 can be spaced from catheter insertion site window 203 at a distance that corresponds to the length of catheter 111. In other words, imaging device pocket 204 can be positioned so that it will be overtop the distal tip of catheter 111 when catheter 111 is inserted into the vasculature and stabilization platform 113 is positioned in vascular access device pocket 202. In some embodiments, imaging device pocket 204 may be a cutout that exposes the patient's skin. In other embodiments, imaging device pocket 204 may be formed of a gel cap to facilitate imaging. The size and shape of imaging device pocket 204 can be selected to accommodate a range of imaging device head shapes and orientations including rectangular, square, or other shape running in the transverse and/or longitudinal orientation.
In some embodiments, imaging device pocket 204 may be at least partially surrounded by a guide 205. In some embodiments, guide 205 may be raised from base layer 201 to form a wall around imaging device pocket 204. Guide 205 may facilitate controlled adjustments to an imaging device 210 when positioned in imaging device pocket 204 such as to control probe angle or rotation across multiple degrees of freedom (e.g., of an ultrasound probe).
In some embodiments where imaging device pocket 204 includes a gel cap, the gel cap may be a single-use stand-alone device that is integrated into the securement platform 200. In other embodiments, the gel cap could be attached to the patient or imaging device 210 to be readily accessible for use within imaging device pocket 204. In some embodiments, the gel cap could have antimicrobial properties to allow imaging device pocket 204 to remain clean through multiple uses of an imaging device 210. In some embodiments, a gel cap could be configured to be capable of being rehydrated so that the gel cap may be used multiple times within imaging device pocket 204.
In some embodiments, securement platform 200 may consist only of component 200b. In such embodiments, securement platform 200 may be positioned appropriately to ensure that imaging device pocket 204 is overtop the distal tip of catheter 111.
A base unit 612, which may be integrated into another component of imaging system 600 in some embodiments, can represent a networking-capable computing device that is configured to communicate with database 614 and possibly with monitoring device(s) 613. For example, in some embodiments, imaging device 210 may interface directly with base unit 612 (e.g., via Bluetooth or another short-range communication protocol) for communicating vascular access data which in turn may communicate with database 614 for storing such vascular access data and/or with monitoring device(s) 613 for displaying such vascular access data. In other embodiments, imaging device 210 may have such networking capabilities and may therefore be viewed as including base unit 612.
A monitoring device 613 can be any computing device that is configured to display data related to the continuity of care. For example, a monitoring device 613 could be a personal computer, smart phone, dedicated computing device/display, etc. on which a web-based interface or dedicated application is used to display vascular access data pertaining to the continuity of care for a patient. Such monitoring devices 613 could be positioned in the patient's room or at a nursing station, carried by a clinician, etc. In some embodiments, a monitoring device 613 may include a base unit 612. For example, a monitoring device 613 could be placed next to a patient and could implement the functionality of a base unit 612 to interface with an imaging device 210 and database 614.
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 could be a dedicated server computing device or cloud storage that is configured to implement database functionality.
The display also includes indicators 802a, 802b, and 802c for different parameters. In some embodiments, these parameters could be selectable. For example, in
The display further includes indicators 803a and 803b that provide information about the portion of catheter 111 that is inside vasculature 701. Indicator 803a defines the catheter to vein ratio (i.e., the ratio of the catheter's diameter to the vein's diameter at a particular location). Indicator 803b defines the purchase of catheter 111 (i.e., the length of catheter 111 that is inside vasculature 701 or the percentage of the catheter length that is inside the vasculature). The display additionally includes an indicator 804 defining a patency status of catheter 111 (i.e., whether catheter 111 can safely remain within vasculature 701). Base unit 612 (or a monitoring device 613) could calculate the patency status using the images provided by imaging device 210 (e.g., to detect the extent to which catheter 111 and/or vasculature 701 around catheter 111 may be blocked).
As suggested above, imaging system 600 can be configured to monitor and/or display information relating to the status of catheter 111, vasculature 701, or the surrounding tissue and a variety of associated physiological or procedural parameters by leveraging images that are provided by imaging device 210. This information includes catheter geometry information (e.g., the catheter to vein ratio, the purchase of the catheter, flow restrictions around the catheter), catheter position information (axial position of the catheter within the vein, the position or angle of the distal tip of the catheter relative a vein wall, valve, branch or other physiological feature), catheter movement or displacement, catheter kinking, dislodgment events, extravasation, infiltration detection (e.g., by monitoring tissue surrounding vasculature 501), thrombus development, phlebitis (visual or correlated cumulative movement), patency indicators, blood flow characteristics (e.g., by using doppler to detect velocity and/or volume of blood flowing into catheter 102), fluid administration flow characteristics (e.g., by using doppler to detect velocity, volume, direction, and/or duration of fluid flow), procedural events (e.g., flush, draw, fluid administration), and/or line draw tubing, probe or sensor position in the vein or relative to the distal tip of the catheter or physiological feature (e.g., thrombus, valve, wall, branch, etc.).
Imaging system 600 may provide a display including indicators of any of the above-mentioned information and may provide corresponding alerts. For example, base unit 612 or a monitoring device 613 may be configured to output a visual, audible, tactile, or digital alert when a condition or event is detected from the ultrasound images.
Base unit 612 may be configured to receive images from imaging device 210 continuously, periodically, on demand, etc. Base unit 612 may include an image processor 612a that is configured to process the images to generate processed image data. This processed image data can be input to an artificial intelligence engine 612b that may be configured to detect and/or generate parameters from the processed image data. The parameters along with the images can be provided to a display module 612c that can generate the display content that includes the images and the parameters.
In some embodiments, image processor 612a can be configured to determine from an image or sequence of images various status information such as catheter geometry or position information or the presence of a thrombus, kink, or other blockage. In some embodiments, artificial intelligence engine 612b can be trained to detect when parameters are present in a stream of images. For example, artificial intelligence engine 612b could detect when a sequence of images is indicative of a flush event, a draw event, the occurrence of extravasation, a dislodgement or movement event, etc. In some embodiments, artificial intelligence engine 612b could be used to predict the development or increasing risk of a potential complication or event. For example, artificial intelligence engine 612b could process images to detect that the catheter purchase is changing or decreasing over time. If this trend is detected or a threshold purchase is reached (e.g., when less than some percentage of catheter length remains in the vein), artificial intelligence engine 612b could cause an alert to be triggered so that a clinician can prevent failure of the catheter.
In some embodiments, artificial intelligence engine 612b (or another artificial intelligence solution) could be used to automatically detect a depth of distal tip 111a from images generated by imaging device(s) 210. The detected depth could then be used to enhance the accuracy of the images. For example, to facilitate the use of C-mode ultrasound, imaging device 210 could generate images at preset depths and then artificial intelligence engine 612b could evaluate the images to identify which image(s) includes catheter 111. The known depth of the identified image(s) could then be used as the depth for generating further C-mode ultrasound images.
All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.
This application claims the benefit of U.S. Provisional Patent Application No. 63/468,940, which was filed on May 25, 2023, which is incorporated herein in its entirety.
Number | Date | Country | |
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63468940 | May 2023 | US |