EP-4734831-A1 - SYSTEM AND METHOD FOR IMAGING IMPLANTED MEDICAL DEVICES

Abstract

A vascular access device (VAD) monitoring system includes a VAD with a catheter tube that is subcutaneously disposed and incorporates a fluorescent dye. An optical imaging system is also provided, comprising a light source emitting infrared (IR) excitation light and a camera capable of detecting signal light emitted by the fluorescent dye upon exposure to the excitation light. This enables real-time monitoring of the VAD, allowing for the detection of any potential complications or issues related to the vascular access device. The combination of the catheter tube with the fluorescent dye and the optical imaging system provides a non- invasive and efficient means of monitoring the VAD, enhancing patient safety and improving overall healthcare outcomes.

Inventors

• MESSERLY, SHAYNE
• KUMAR, MANISH
• NALAWADE, Praveen
• MYSURU RAMESH KUMAR, Karthik
• PRASAD, Shishir
• BURKHOLZ, JONATHAN, KARL

Assignees

• Bard Access Systems, Inc.

Dates

Publication Date

20260506

Application Date

20240730

Claims (20)

1. 1. A vascular access device (VAD) monitoring system comprising: a VAD having a catheter tube disposed distally and configured to be disposed subcutaneously, the catheter tube including a dye; and an optical imaging system including: a light source configured to emit excitation light; and a camera configured to detect signal light emitted from the dye when the dye is exposed to the excitation light.
2. 2. The VAD monitoring system according to claim 1, wherein the excitation light includes electromagnetic radiation in a range of 700 nm to 1 mm.
3. 3. The VAD monitoring system according to either claim 1 or claim 2, wherein the excitation light includes electromagnetic radiation in a range of 700 nm to 2500 nm.
4. 4. The VAD monitoring system according to any of the preceding claims, wherein the dye is formed integrally with a wall of the catheter tube.
5. 5. The VAD monitoring system according to any of the preceding claims, wherein the dye is included in a coating disposed on a surface of the catheter tube.
6. 6. The VAD monitoring system according to any of the preceding claims, wherein the excitation light has a first wavelength range and the signal light has a second wavelength range, different from the first wavelength range.
7. 7. The VAD monitoring system according to any of the preceding claims, wherein the VAD further includes a dressing configured to adhere to a skin surface of a patient and includes a fiduciary marker configured to align one or both of the light source and the camera with a portion of the catheter tube disposed subcutaneously therebelow.
8. 8. The VAD monitoring system according to any of the preceding claims, wherein the light source and the camera are provided as a single handheld device.
9. 9. The VAD monitoring system according to any of claims 1-7, wherein the light source and the camera are provided as separate stand-alone devices.
10. 10. The VAD monitoring system according to claim 7, wherein the light source is included on the dressing.
11. 11. The VAD monitoring system according to any of the preceding claims, wherein the optical imaging system includes an excitation light logic, a signal light logic, and an image analysis logic configured to analyze the signal light detected by the camera and detect a change in the signal light relative to a threshold image.
12. 12. The VAD monitoring system according to claim 11, wherein the threshold image generated from one or more previous images of the VAD is generated by the optical imaging system.
13. 13. The VAD monitoring system according to either claim 11 or claim 12, wherein the optical imaging system determines a quantified change in the signal light and displays the quantified change as a metric on a display of the optical imaging system.
14. 14. The VAD monitoring system according to any of claims 11-13, wherein the image analysis logic of the optical imaging system is configured to analyze the signal light and generate an image of the catheter tube and determine one or more of an occlusion, a thrombosis, an abluminal biofilm, an intraluminal biofilm, a fibrin sheath, a catheter tube dislodgement, a loss of patency of the catheter tube, a catheter tube collapse, damage to the catheter tube, a proximity of a distal tip of the catheter tube to a vascular valve, or a proximity of the distal tip of the catheter tube to a vascular bifurcation.
15. 15. A method of detecting a complication with a vascular access device (VAD) disposed within a patient, comprising: providing excitation light to a skin surface of the patient; impinging the excitation light on a dye included with a catheter tube of the VAD disposed subcutaneously; emitting signal light from the dye; detecting the signal light by a camera disposed externally to the patient; determining an image of the VAD; and analyzing the image to determine if the complication is present based on a change in the signal light relative to a threshold image data.
16. 16. The method according to claim 15, further including providing the excitation light in an infrared (IR) or near infrared (NIR) spectra.
17. 17. The method according to either claim 15 or claim 16, wherein the dye is formed integrally within a wall of the catheter tube.
18. 18. The method according to either claim 15 or claim 16, wherein the dye is included in a coating disposed on a surface of the catheter tube.
19. 19. The method according to any of claims 15-18, wherein the threshold image data is generated from one or more previous images of the VAD.
20. 20. The method according to any of claims 15-19, wherein the complication includes one or more of an occlusion, a thrombosis, an abluminal biofilm, an intraluminal biofilm, a fibrin sheath, a catheter tube dislodgement, a loss of patency of the catheter tube, a catheter tube collapse, damage to the catheter tube, a proximity of a distal tip of the catheter tube to a vascular valve, and a proximity of the distal tip of the catheter tube to a vascular bifurcation.

Description

SYSTEM AND METHOD FOR IMAGING IMPLANTED MEDICAL DEVICES PRIORITY [0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/530,003, filed July 31, 2023, which is incorporated in its entirety into this application. BACKGROUND [0002] Briefly summarized, embodiments of the present invention are directed to systems and methods for the placing and monitoring of sub-dermal implanted medical devices by optical imaging. Various complications can occur during the placement and/or during the useful life span, or dwell time, of sub-dermal implanted medical devices, such as catheters and/or ports. Exemplary complications incurred include misplacement of the distal tip, missing the target vessel, accessing the incorrect vessel, backwalling, distal tip placement adjacent a valve or bifurcation, infiltration, extravasation, dislodgement, occlusion, loss of patency, infection, catheter collapse, catheter kinking, catheter movement, thrombus development, phlebitis, or the like. Further localized changes in a patient’s physiology can further affect the functional dwell time of the medical device, for example vein or arterial size changes, collapse, stiffening, damage, or the like may lead to further complications. Such complications can be difficult to diagnose without disturbing the placement of the medical device. Often such devices are removed prematurely due to a false positive diagnosis of a problem. Alternatively, such complications can go undetected leading to reduced efficacy of the treatment or increased patient morbidity. [0003] Further, complications with the placement of the medical device can be equally challenging. Choosing the placement location, placing the medical device, and confirming correct placement of the medical device often cannot be directly observed and as such clinicians either rely on fluoroscopic imaging to confirm correct placement or rely on secondary indicators to identify any problems in the placement procedure. Fluoroscopic imaging exposes the patient to harmful radiation and relying on secondary indicators fails to preempt problems that may otherwise be avoidable if they had been detected earlier. Optionally, clinicians utilize ultrasonic imaging techniques to image sub-dermal VAD’s. However, these imaging techniques suffer from a limited field of view and are susceptible to reflectivity problems that introduce “noise” to the image and/or fail to distinguish between tissue structures or medical device structures that have similar acoustic impedance properties. [0004] What is needed therefore is a system and method to assess and monitor the position, status and viability of indwelling VAD’s without relying on potentially harmful imaging techniques. Such systems can confirm correct placement and compare the current status of an indwelling VAD with previous states, or compared with established standards of care, to predict and identify VAD related complications. Such systems can be important in the acute care and alternate care settings to reduce the patient complications and experience, reduce clinician burden, and improve overall effectiveness of the patient’s treatment and care. SUMMARY [0005] In some aspects, the techniques described herein relate to a vascular access device (VAD) monitoring system including, a VAD having a catheter tube disposed distally and configured to be disposed subcutaneously, the catheter tube including a dye, and an optical imaging system including, a light source configured to emit excitation light, and a camera configured to detect signal light emitted from the dye when the dye is exposed to the excitation light. [0006] In some aspects, the techniques described herein relate to a VAD monitoring system wherein the excitation light includes electromagnetic radiation in a range of 700 nm - 1 mm. [0007] In some aspects, the techniques described herein relate to a VAD monitoring system wherein the excitation light includes electromagnetic radiation in a range of 700 nm - 2500 nm. [0008] In some aspects, the techniques described herein relate to a VAD monitoring system wherein the dye is formed integrally with a wall of the catheter tube. [0009] In some aspects, the techniques described herein relate to a VAD monitoring system, wherein the dye is included in a coating disposed on a surface of the catheter tube. [0010] In some aspects, the techniques described herein relate to a VAD monitoring system wherein the excitation light has a first wavelength range and the signal light has a second wavelength range, different from the first wavelength range. [0011] In some aspects, the techniques described herein relate to a VAD monitoring system wherein the VAD further includes a dressing configured to adhere to a skin surface of a patient and includes a fiduciary marker configured to align one or both of the light source and the camera with a portion of the catheter tube disposed subcutaneously therebelow. [0012] In some aspects, the