Vascular access device monitoring system and medical device imaging system

Abstract

The utility model relates to a vascular access device monitoring system and a medical device imaging system. A vascular access device monitoring system includes: a vascular access device having a catheter tube disposed distally and configured to be disposed subcutaneously, the catheter tube including a dye; and an optical imaging system, the optical imaging system comprising 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.

Description

[0001] Priority

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 530,003, filed Jul. 31, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more particularly to vascular access device monitoring systems and medical device imaging systems. Background Art

[0004] Briefly summarized, embodiments of the present disclosure relate to systems and methods for placing and monitoring subcutaneous implantable medical devices by optical imaging. During and / or over the useful life or dwell time of a subcutaneous implantable medical device (such as a catheter and / or port), various complications can occur. Exemplary complications that can arise include distal tip misalignment, missed target vasculature, entry into the incorrect vasculature, backwalling, placement of the distal tip near a valve or bifurcation, infiltration, extravasation, displacement, occlusion, loss of patency, infection, catheter collapse, catheter kinking, catheter movement, thrombosis, phlebitis, etc. Further local changes in the patient's physiology can further affect the functional dwell time of the medical device; for example, changes in vein or artery size, collapse, sclerosis, damage, etc. can lead to further complications. It can be difficult to diagnose such complications without disturbing the placement of the medical device. Typically, such devices are removed prematurely due to false positive diagnoses of problems. Alternatively, such complications may not be detected, resulting in reduced treatment efficacy or increased patient morbidity.

[0005] In addition, complications associated with placing medical devices can be equally challenging. Selecting a placement location, placing the medical device, and confirming proper placement of the medical device are often not directly observable, and thus clinicians rely on fluoroscopic imaging to confirm proper placement or on adjunctive indicators to identify any problems in the placement procedure. Fluoroscopic imaging exposes the patient to harmful radiation and relying on adjunctive indicators does not prevent problems that could have been avoided if detected earlier. Alternatively, clinicians image subcutaneous VADs using ultrasound imaging techniques. However, these imaging techniques suffer from a limited field of view and are susceptible to reflectivity issues that introduce "noise" into the image and / or cannot distinguish between tissue structures or medical device structures with similar acoustic impedance properties.

[0006] Accordingly, there is a need for a system and method for evaluating and monitoring the position, status, and viability of an indwelling VAD without relying on potentially harmful imaging techniques. Such a system can confirm proper placement and compare the current status of the indwelling VAD to a previous status or to established standards of care to predict and identify VAD-related complications. Such a system is important in acute care and alternative care settings for reducing patient complications and experiences, reducing clinician burden, and improving the overall effectiveness of patient handling and care. Summary of the Utility Model

[0007] In some aspects, the techniques described herein relate to a vascular access device (VAD) monitoring system that includes: a VAD having a catheter member disposed distally and configured to be disposed subcutaneously, the catheter member 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.

[0008] In some aspects, the techniques described herein relate to a VAD monitoring system, wherein the excitation light includes electromagnetic radiation in the range of 700 nm to 1 mm.

[0009] In some aspects, the techniques described herein relate to a VAD monitoring system, wherein the excitation light includes electromagnetic radiation in the range of 700 nm to 2500 nm.

[0010] In some aspects, the techniques described herein relate to a VAD monitoring system, wherein the dye is integrally formed with the wall of the catheter member.

[0011] In some aspects, the techniques described herein relate to a VAD monitoring system, wherein the dye is included in a coating disposed on the surface of the catheter member.

[0012] 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.

[0013] In some aspects, the techniques described herein relate to a VAD monitoring system, wherein the VAD further includes a dressing configured to adhere to the skin surface of the 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 member disposed subcutaneously therebeneath.

[0014] In some aspects, the techniques described herein relate to a VAD monitoring system, wherein the light source and the camera are provided as a single handheld device.

[0015] In some aspects, the techniques described herein relate to a VAD monitoring system in which a light source and a camera are provided as separate, independent devices.

[0016] In some aspects, the techniques described herein relate to a VAD monitoring system in which the light source is included on a dressing.

[0017] In some aspects, the techniques described herein relate to a VAD monitoring system in which the optical imaging system includes excitation light logic, signal light logic, and image analysis logic, and the image analysis logic is configured to analyze the signal light detected by the camera and detect changes in the signal light relative to a threshold image.

[0018] In some aspects, the techniques described herein relate to a VAD monitoring system in which a threshold image generated from one or more previous images of the VAD is generated by the optical imaging system.

[0019] In some aspects, the techniques described herein relate to a VAD monitoring system in which 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.

[0020] In some aspects, the techniques described herein relate to a VAD monitoring system in which the image analysis logic of the optical imaging system is configured to analyze the signal light and generate an image of the catheter fitting and determine one or more of the following: occlusion, thrombosis, distal lumen biofilm, intraluminal biofilm, fibrin sheath, catheter fitting displacement, loss of patency of the catheter fitting, catheter fitting collapse, damage to the catheter fitting, proximity of the distal end of the catheter fitting to a vascular valve, or proximity of the distal end of the catheter fitting to a vascular bifurcation.

[0021] In some aspects, the techniques described herein relate to a method of detecting a complication associated with a vascular access device (VAD) disposed within a patient, the method including: providing excitation light to a skin surface of the patient; irradiating the excitation light on a dye included with a subcutaneous catheter fitting of the VAD; emitting signal light from the dye; detecting the signal light with a camera disposed outside the patient; determining an image of the VAD; and analyzing the image to determine whether a complication is present based on changes in the signal light relative to threshold image data.

[0022] In some aspects, the techniques described herein relate to a method further including providing excitation light in the infrared (IR) or near-infrared (NIR) spectrum.

[0023] In some aspects, the techniques described herein relate to a method in which the dye is integrally formed within the wall of the catheter fitting.

[0024] In some aspects, the techniques described herein relate to a method in which a dye is included in a coating disposed on the surface of a catheter fitting.

[0025] In some aspects, the techniques described herein relate to a method in which threshold image data is generated from one or more previous images of a VAD.

[0026] In some aspects, the techniques described herein relate to a method in which complications include one or more of the following: occlusion, thrombosis, distal lumen biofilm, intraluminal biofilm, fibrin sheath, catheter fitting displacement, loss of patency of the catheter fitting, catheter fitting collapse, damage to the catheter fitting, proximity of the distal end of the catheter fitting to a vascular valve, and proximity of the distal end of the catheter fitting to a vascular bifurcation.

[0027] In some aspects, the techniques described herein relate to a medical device imaging system comprising: a medical device having a catheter fitting and including a distal portion disposed within a blood vessel, the catheter fitting including a dye, the dye being included with the distal portion of the catheter fitting disposed within the blood vessel; and an optical imaging system disposed externally and including a light source for emitting excitation light to irradiate the dye and a camera for detecting signal light emitted from the dye of the distal portion to provide an image in order to determine the shape of the distal portion of the medical device and to determine the presence of a structural abnormality or deposit.

[0028] In some aspects, the techniques described herein relate to a medical device imaging system comprising: a medical device having a catheter fitting and including a distal portion disposed within a blood vessel, the catheter fitting including a dye; and an optical imaging system disposed externally and including a light source, a camera, and a console, the console including one or more logic modules stored within a non-transitory storage medium, the one or more logic modules performing operations when executed by one or more processors, the operations including: emitting excitation light from the light source to irradiate the dye, the dye being included with the distal portion of the catheter fitting disposed within the blood vessel; detecting signal light emitted from the dye of the distal portion to provide an image; parsing the image to determine the shape of the distal portion of the medical device; and comparing the parsed image against threshold data to determine the presence of a structural abnormality or deposit.

[0029] In some aspects, the techniques described herein relate to a medical device imaging system in which the excitation light includes electromagnetic radiation in the infrared or near-infrared range.

[0030] In some aspects, the techniques described herein relate to a medical device imaging system in which the dye is integrally formed with the wall of the catheter fitting or is included in a coating disposed on the surface of the catheter fitting.

[0031] In some aspects, the techniques described herein relate to a medical device imaging 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.

[0032] In some aspects, the techniques described herein relate to a medical device imaging system, wherein the medical device further includes a dressing configured to adhere to the skin surface of a patient and includes fiducial markers configured to align one or both of a light source and a camera with a distal portion of a catheter member disposed subcutaneously therebeneath.

[0033] In some aspects, the techniques described herein relate to a medical device imaging system, wherein analyzing the parsed image against a threshold data further includes training a machine learning model with a plurality of labeled images, the trained machine learning model being configured to identify a structural anomaly or deposit disposed on the medical device and provide a warning to a user.

[0034] In some aspects, the techniques described herein relate to a medical device imaging system, wherein the plurality of labeled images include: a labeled image of the medical device including a deposit, a labeled image of the medical device including a structural anomaly, and a labeled image of the medical device without a deposit or structural anomaly. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] A more particular description of the disclosure will be presented by reference to specific embodiments of the disclosure shown in the drawings. It is to be understood that these drawings only depict typical embodiments of the present invention and are not to be considered as limiting the scope of the present invention. The exemplary embodiments of the present invention will be described and explained with additional particularity and detail by using the drawings, wherein:

[0036] Figure 1A A perspective view of a vascular access device (VAD) monitoring system in accordance with an embodiment disclosed herein is shown.

[0037] Figure 1B A perspective view of a first VAD and a second VAD coupled in accordance with an embodiment disclosed herein is shown. Figure 1A of a first VAD and a second VAD coupled is shown.

[0038] Figure 1C A close-up detail of a distal end segment of a device in accordance with an embodiment disclosed herein is shown. Figure 1B of a device is shown.

[0039] Figure 2A A perspective cross-sectional view of a distal end of a VAD disposed within a blood vessel near a valve in accordance with an embodiment disclosed herein is shown.

[0040] Figure 2BShows a perspective cross-sectional view of the distal end of a VAD disposed within a blood vessel near a bifurcation, according to an embodiment disclosed herein.

[0041] Figure 2C Shows a schematic side view of the distal portion of a catheter fitting disposed within a blood vessel, according to an embodiment disclosed herein.

[0042] Figure 2D Shows, according to an embodiment disclosed herein, Figure 2C A schematic plan view of the distal portion of a catheter fitting of [[]] disposed subcutaneously and imaged by an optical imaging system.

[0043] Figure 3A Shows a schematic side view of a portion of a catheter fitting disposed subcutaneously and including one or more deposits, according to an embodiment disclosed herein.

[0044] Figure 3B Shows, according to an embodiment disclosed herein, Figure 3A A schematic plan view of a catheter fitting of [[]] imaged by an optical imaging system.

[0045] Figure 4A Shows a schematic plan view of a catheter fitting imaged by an optical imaging system and having no deposits or structural deformations, according to an embodiment disclosed herein.

[0046] Figures 4B to 4E Shows, according to an embodiment disclosed herein, Figure 4A A schematic plan view of a catheter fitting of [[]] imaged by an optical imaging system and including one or more complications.

[0047] Figure 5 Shows a schematic diagram of an optical imaging system, according to an embodiment disclosed herein. Detailed Description

[0048] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features can optionally be combined with or replace the features of any one of many other embodiments disclosed herein. It should be understood that the drawings are schematic and diagrammatic representations of exemplary embodiments of the present invention and are neither limiting nor necessarily drawn to scale.

[0049] Regarding the terms used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not provide a sequence or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily occur in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Additionally, as used herein (including in the claims), the words "comprising", "having", and "containing" shall have the same meaning as the word "including".

[0050] In the following description, the term "or" and "and / or" as used herein shall be interpreted as inclusive or meaning either or any combination. As an example, "A, B, or C" or "A, B, and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B, and C". An exception to this definition occurs only when the combination of elements, components, functions, steps, or acts is inherently mutually exclusive in some way.

[0051] Relative to "proximal", for example, the "proximal portion" or "proximal end portion" of a catheter or system disclosed herein includes the part of the catheter or system that is intended to be placed near or relatively closer to a clinician when the catheter or system is used in a patient. Similarly, for example, the "proximal length" of a catheter or system includes the length of the catheter or system that is intended to be placed near or relatively closer to a clinician when the catheter or system is used in a patient. For example, the "proximal end" of a catheter or system includes the end of the catheter or system that is intended to be placed near or relatively closer to a clinician when the catheter or system is used in a patient. The proximal portion, proximal end portion, or proximal length of a catheter or system may include the proximal end of the catheter or system; however, the proximal portion, proximal end portion, or proximal length of a catheter or system does not need to include the proximal end of the catheter or system. That is, unless the context otherwise indicates, the proximal portion, proximal end portion, or proximal length of a catheter or system is not necessarily the terminal portion or terminal length of the catheter or system.

[0052] Relative to "distal", for example, the "distal portion" or "distal end portion" of a catheter or system as disclosed herein includes a portion of the catheter or system that is intended to be positioned near or relatively closer to a patient when the catheter or system is used in a patient. Similarly, for example, the "distal length" of a catheter or system includes the length of the catheter or system that is intended to be positioned near or relatively closer to a patient when the catheter or system is used in a patient. For example, the "distal end" of a catheter or system includes the end of the catheter or system that is intended to be positioned near or relatively closer to a patient when the catheter or system is used in a patient. The distal portion, distal end portion, or distal length of a catheter or system may include the distal end of the catheter or system; however, the distal portion, distal end portion, or distal length of a catheter or system need not include the distal end of the catheter or system. That is, unless the context otherwise indicates, the distal portion, distal end portion, or distal length of a catheter or system is not necessarily the end portion or end length of the catheter or system.

[0053] The term "logic" can represent hardware, firmware, or software configured to perform one or more functions. As hardware, the term "logic" can refer to or include a circuit having data processing and / or storage capabilities. Examples of such circuits can include, but are not limited to or restricted to, a hardware processor (e.g., a microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit "ASIC", etc.), a semiconductor memory, or a combination of elements.

[0054] Additionally or alternatively, the term "logic" can refer to or include software, such as one or more processes, one or more instances, an application programming interface (API), a subroutine, a function, an applet, a servicelet, a routine, source code, object code, a shared library / dynamic link library (dll), or even one or more instructions. The software can be stored in any type of suitable non-transitory storage medium or transitory storage medium (e.g., an electrical, optical, acoustic, or other form of propagated signal, such as a carrier wave, an infrared signal, or a digital signal). Examples of non-transitory storage media can include, but are not limited to or restricted to: programmable circuits; non-persistent storage devices, such as volatile memory (e.g., any type of random access memory "RAM"); or persistent memory, such as non-volatile memory (e.g., read-only memory "ROM", power-supplied RAM, flash memory, phase change memory, etc.), a solid state drive, a hard disk drive, an optical disk drive, or a portable memory device. As firmware, the logic can be stored in a persistent storage device.

[0055] To assist in describing the embodiments described herein, as Figure 1A shown, the longitudinal axis extends substantially parallel to the axial length of the catheter fitting 112. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal axis and the lateral axis.

[0056] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0057] Figure 1A An exemplary vascular access device ("VAD") monitoring system ("system") 100 is shown, which generally includes a vascular access device ("VAD") system 110 and an optical imaging system 130. Exemplary vascular access devices (VADs) 110 can include, but are not limited to: single lumen catheters, multi-lumen catheters, midline catheters, venous catheters, peripheral intravenous catheters (PIVCs), peripheral venous outflow devices (PIVOs), central venous catheters (CVCs), peripherally inserted central catheters (PICCs), rapidly insertable central catheters (RICCs), access sites, ports, subcutaneous access ports, and the like.

[0058] In one embodiment, the VAD 110 includes a catheter fitting 112 that defines a lumen 118 and extends along a longitudinal axis. The catheter fitting 112 is supported at its proximal end by a catheter hub 114. The catheter fitting 112 can be formed of plastic, polymer, elastomer, silicone, rubber, polymethyl methacrylate (PMMA), or other suitable materials. The distal end of the catheter fitting 112 extends percutaneously into the patient's body at the insertion site 90 to a target location. The catheter hub 114 is configured to remain outside the patient's body. However, it should be understood that this is not intended to be limiting, and various parts of the VAD 110 (or in some embodiments, the entire VAD 110) can be disposed subcutaneously. For example, when the VAD 110 includes a subcutaneous access port coupled to the catheter, the entire VAD 110 can be disposed subcutaneously. In one embodiment, the VAD 110 can also include various numbers or combinations of catheter fittings, hubs, connectors, stabilizing wings, extension legs, auxiliary VADs, and the like coupled thereto.

[0059] In one embodiment, the VAD system 110 can also include a dressing 116 that is configured to adhere to the patient's skin surface and, optionally, simultaneously adhere to a portion of the VAD 110. The dressing 116 can form a barrier over the insertion site 90, thereby reducing infection. Additionally, the dressing 116 can stabilize the portion of the VAD 110 disposed outside the patient's body.

[0060] In one embodiment, as Figures 1B to 1CAs shown, system 100 may include a second VAD 210 coupled to a first VAD 110. For example, the first VAD 110 may be a PIV catheter that includes a first catheter fitting 112A and provides access to a vasculature. The second VAD 210 may include a PIVO that is configured to couple to a bushing 114 of the first VAD 110 and slide a second catheter fitting 112B through the lumen 118 of the first catheter fitting 112A to access the vasculature system. In one embodiment, the second VAD 210 may be configured to engage the first VAD 110 to access the vasculature system and aspirate a blood sample without having to puncture the vasculature at a location separate from the first VAD 110.

[0061] In one embodiment, one or more portions of the VAD 110 may include a dye 120 that is configured to reflect, absorb, and / or fluoresce when exposed to electromagnetic (EM) radiation such as infrared (IR) or near-infrared (NIR) spectra. However, it should be understood that the embodiments described herein may also utilize other EM spectra with larger or smaller wavelengths (e.g., optical or ultraviolet). As used herein, the infrared (IR) spectrum includes wavelengths in the range of 700 nm to 1 mm. As used herein, the near-infrared (NIR) spectrum includes wavelengths in the range of 700 nm to 2500 nm.

[0062] In one embodiment, the dye 120 is integrally formed with one or more portions of the VAD 110, e.g., integrally formed with a polymer used to form the walls of the catheter fitting 112, bushing 114, etc. In one embodiment, the dye 120 is included in a coating disposed on the surface of the VAD 110 (e.g., on the inner surface of the catheter lumen 118 and / or on the outer surface of the catheter fitting 112). In one embodiment, the dye 120 is an agglomerated nanoparticle having a primary particle size between 10 nm and 50 nm. However, other primary particle sizes that are larger or smaller are also contemplated. In one embodiment, the dye 120 includes cyanine dyes, antimony tin oxide (ATO), indium tin oxide (ITO), doped tungsten oxide (CTO), and combinations thereof, etc. It should be understood that these dyes are exemplary and other dyes are also contemplated.

[0063] In one embodiment, the dye 120 is configured to reflect, transmit, and / or absorb EM radiation wavelengths differently than the surrounding tissue or fluid. For example, the dye 120 may provide greater reflection, less transmission, and / or less absorption of EM radiation compared to blood, and less reflection, greater transmission, and / or greater absorption of EM radiation compared to the blood vessel wall tissue. Thus, when visualized through the optical imaging system 130, the portion of the VAD 110 that includes the dye 120 appears less opaque than the blood, but less opaque than the blood vessel wall tissue. It should be understood that these are exemplary, and other combinations of greater or lesser reflection, transmission, or absorption between the dye 120 and the blood, surrounding tissue, etc. are also contemplated.

[0064] In one embodiment, the dye 120 may be configured to fluoresce under EM radiation. For example, the dye 120 may be configured to absorb EM radiation of a first wavelength and, in response, emit EM radiation of a second wavelength different from the first wavelength. The second wavelength may be configured to be different from the reflection wavelengths from the surrounding tissue / blood in order to distinguish the VAD 110 or portions thereof from such surrounding tissue / fluids, as described herein.

[0065] In one embodiment, different concentrations of the dye 120 may affect the amount of reflection, transmission, or absorption of EM radiation through the VAD 110. For example, a relatively high concentration of the dye 120 will provide relatively high reflection of EM radiation and provide relatively greater reflection or absorption of EM radiation. Different colors of the dye 120 may provide different absorption of EM radiation. For example, black or dark colors provide greater absorption of EM radiation, while white or light colors provide greater reflection of EM radiation. Different surface characteristics of the dye particles 120 provide different reflection properties of EM radiation. For example, a smoother surface of the dye particles provides greater reflection of EM radiation compared to a rougher or more uneven surface of the dye particles. Finally, different fluorescence properties of the dye 120 may provide different emission light properties. For example, the dye 120 may absorb EM radiation of a first wavelength or wavelength range and emit EM radiation of a second wavelength or wavelength range, as described herein. Thus, modifying these different properties of the dye 120 can facilitate distinguishing the dye 120 and the associated structures of the VAD 110 from the surrounding tissue and fluids when imaged by the optical imaging system 130, as described herein.

[0066] Continuing reference Figure 1A, in one embodiment, system 100 further includes an optical imaging system 130. The optical imaging system 130 is configured to emit, for example, excitation light 160 from a light source 132, and the excitation light is capable of penetrating the surface layers of the skin 70, subcutaneous tissue 72, and vessel wall 74 to irradiate at least a portion of the VAD 110. In other words, the optical imaging system 130 is configured to emit electromagnetic radiation in the infrared (IR) and / or near-infrared (NIR) spectrum to penetrate the surface layers of the skin 70, subcutaneous tissue 72, and vessel wall 74 to irradiate the subcutaneous portion of the VAD 110. In one embodiment, the excitation light 160 will be capable of penetrating the skin surface tissue to a depth of about 2 cm. However, greater or lesser depths are also contemplated.

[0067] In one embodiment, the excitation light 160 from the light source 132 irradiates on the VAD 110, the dye 120, or a combination thereof, such that the dye 120 reflects, absorbs, and / or fluoresces. The wavelength of the reflected light 164 may be the same as or different from the wavelength of the excitation light 160. In the case where the dye 120 is configured to fluoresce, the dye 120 absorbs the excitation light 160 and emits signal light 162. The signal light 162 is the same as or different from the excitation light 160. The optical imaging system 130 further includes a camera 134 or a similar device configured to detect the reflected light 164 and / or the signal light 162.

[0068] Figures 2A to 2D A schematic diagram of the VAD 110 disposed within the vessel 74 is shown. Figure 2A A perspective sectional view of the distal portion of the VAD 110 is shown, and the distal portion extends through the insertion site 90 on the skin surface 70 to enter the vessel 74. Figure 2B A perspective sectional view of the distal portion of the VAD 110 is shown. The VAD has a first catheter fitting 112A and a second catheter fitting 112B, and the second catheter fitting is disposed within the lumen of the first catheter fitting 112A to enter the vessel 74. Figure 2C A schematic side view of a subcutaneous portion of the catheter fitting 112 disposed within the vessel 74 is shown. Figure 2D A schematic plan view of a subcutaneous portion of the catheter fitting 112 disposed and imaged by the optical imaging system 130 is shown.

[0069] The dye 120 disposed in the coating on the VAD 110 or disposed on the VAD 110 is configured to reflect, transmit, absorb, and / or fluoresce to distinguish the VAD 110 from the surrounding tissue and fluid. As Figure 2AAs shown, the first excitation light 160A from the light source 132 can transmit through certain tissues (e.g., blood) or be absorbed by them. The second excitation light 160B can transmit through some tissues (e.g., the skin surface tissue 70, the subcutaneous tissue 72) and be reflected by the dye 120 in the catheter fitting 112 as 162B. The third excitation light 160C can transmit through some tissues (e.g., the skin surface tissue 70) and be reflected by other tissues (e.g., the subcutaneous tissue 74) as 162C. In one embodiment, the first excitation light 160A, the second excitation light 160B, and the third excitation light 160C can be different wavelengths or wavelength ranges from each other. In one embodiment, the first excitation light 160A, the second excitation light 160B, and the third excitation light 160C can be the same wavelength or wavelength range, and they are differently reflected, transmitted, or absorbed based on the structures or fluids they irradiate. In one embodiment, the second catheter fitting 112B can be configured to reflect light / fluoresce differently from the first catheter fitting 112A. Thus, the system 100 can distinguish between two or more VADs disposed within a blood vessel.

[0070] Advantageously, the system 100 can facilitate visualization of the placement of the VAD 110, e.g., the placement of the distal end of the catheter fitting 112 within the vessel 74. The system 100 can facilitate visualization of the placement of the catheter fitting 112 to ensure proper entry into the vessel 74 and to mitigate entry into an incorrect vessel, infiltration, extravasation, or posterior wall perforation. As used herein, the term "posterior wall perforation" includes extending the catheter through the first wall of the vessel 74 to enter the vessel and then traversing the posterior wall of the vessel 74 such that the distal end is placed outside the vessel 74.

[0071] Advantageously, the system 100 can facilitate visualization of the VAD 110 to prevent placement of the distal end of the catheter fitting 112 near the valve 76. As Figure 2A shown, since the system 100 can distinguish between blood, vessel tissue 74, and the VAD 110, the system 100 can identify whether the distal end of the catheter fitting 112 is disposed near the valve 76. If placed too close to the valve 76, when aspirating blood from the vessel 74, the pressure can cause the valve 76 to close, preventing further blood withdrawal, or can cause damage to the valve 76 itself. Advantageously, as Figure 2B shown, the system 100 can identify whether the distal end of the catheter fitting 112 (e.g., the first catheter fitting 112A) is disposed near the bifurcation 78. Aspirating blood from the bifurcation can cause blood to flow retrograde through the vessel 74, causing discomfort to the patient and leading to complications.

[0072] As Figure 2CAs shown, the dye 120 is included substantially uniformly throughout the material forming the wall of the catheter fitting 112. Alternatively or additionally, the dye 120 is included substantially uniformly throughout a coating disposed on the surface of the catheter fitting 112. When the excitation light 160 penetrates the skin surface 70 and the surface tissue 72 and irradiates the catheter fitting 112, the excitation light 160 reflects / excites the dye 120, causing the dye 120 to emit signal light 162 or reflect reflected light 164. The signal light 162 / reflected light 164 contrasts with the surrounding tissue, allowing the catheter fitting 112 to be imaged.

[0073] Relative to other imaging modalities (e.g., fluoroscopy, ultrasound, etc.), the optical imaging system 130 using EM radiation provides high-resolution images of the subcutaneous portion of the VAD 110 against the surrounding tissues and structures. Note that the different components of the subcutaneous structures will reflect and absorb the excitation light 160 differently, allowing these structures (e.g., blood vessels, muscle, dermis, etc.) to be imaged relative to the fluorescing and / or differently reflecting VAD 110, as described herein. Advantageously, the system 100 can be used to: i) determine the correct placement of the subcutaneous structures of the VAD 110; ii) determine the presence / absence and / or extent of thrombus or occlusion on the VAD 110; and iii) determine any physical damage, dislodgment, or kinking of the VAD 110.

[0074] As Figure 2D shown, in one embodiment, when viewed from above, the relative concentration of the dye 120 is greater towards the lateral sides of the catheter fitting 112 (i.e., the edges of the catheter fitting 112) relative to the central portion of the catheter fitting 112. Thus, the edges of the catheter fitting 112 appear "brighter" relative to the central lumen 118 of the catheter fitting 112 because the signal light 162 / reflected light 164 is relatively greater at these portions. Accordingly, the structure of the catheter fitting 112 can be discerned in the images provided by the optical imaging system 130. Advantageously, the optical imaging system 130 can detect any misalignment or structural abnormalities of the catheter fitting 112 when placed subcutaneously, such as torsion or kinking.

[0075] For example, incorrect placement of the catheter fitting 112 can cause various problems. In the case where the distal end fails to access the vasculature or breaks through the distal wall of the vasculature and re-enters the surrounding tissue, fluid can leak into the surrounding tissue, resulting in infiltration or extravasation. Such situations can be avoided if the VAD is pre-imaged using the system 100. When the patient returns for repeat procedures, the placement of the VAD 110 can be confirmed before the start of the procedure to ensure that the VAD 110 has not moved or shifted during the transition period between placement and the procedure. Additionally, the clinician can confirm the integrity of the VAD device before the start of the procedure to ensure that no damage or kinking has occurred.

[0076] Figure 3A A schematic side view showing a portion of the conduit fitting 112 disposed subcutaneously and including one or more deposits 170 disposed thereon. Figure 3B Shows Figure 3A A schematic plan view of the conduit fitting 112 when imaged by the optical imaging system 130. The one or more deposits 170 may include biofilms, fibrin sheaths, thrombus formations, blood clots, etc. The deposits 170 may form regularly or irregularly on the outer surface of the conduit fitting 112, or within the conduit lumen 118, e.g., on the inner surface of the conduit lumen 118.

[0077] The deposit 170 affects the reception of the excitation light 160 by the dye 120 in the VAD 110, and / or the emission of the signal light 162 / reflected light 164 from the dye, and as Figure 3B shown, when imaged by the optical imaging system 130, it may affect the "brightness" or contrast of the conduit fitting 112 relative to the surrounding tissue. For example, as shown, the deposit 170 appears as a relatively "dark" contrast region on the image of the conduit fitting 112. The effect of the deposit 170 on the dye 120 can provide unique patterns and / or contrast differences that can be used to diagnose various complications described herein.

[0078] Figures 4A to 4E An exemplary image of the VAD 110 disposed within a blood vessel is shown, as well as various complications that can be diagnosed based on the differential reflection / emission of EM radiation detected by the system 100. Figure 4A A schematic image of the conduit fitting 112 without any deposits 170 or structural deformations is shown. As shown, the blood vessel wall 74 reflects differently from the blood within the blood vessel 74. The conduit fitting 112 also fluoresces / reflecs differently from either the blood vessel wall or the blood to distinguish from both. Due to the increasing material depth, the dye 120 is more concentrated at the edges of the conduit fitting 112, so the wall of the conduit fitting 112 can be distinguished from the lumen 118. Thus, the system 100 can determine that the lumen 118 is free of deposits 170, occlusions, or structural deformations, as described herein. Optionally, the system 100 can use such an image as a baseline or threshold image. The baseline or threshold image can be established from an image of the VAD 110 shortly after placement, from multiple images of the VAD 110 over time, or from a pre - determined standard of care image stored locally or remotely.

[0079] Figure 4BShows a schematic image of the catheter fitting 112 with a biofilm deposit 170 within the lumen. Since the biofilm within the lumen only obstructs the reflected light / fluorescence from the lumen 118 and presents in a relatively uniform manner along the lumen 118, the reflected light / fluorescence from the vessel wall 74, blood, and the catheter fitting wall 112 is relatively unchanged, where the reflected light / fluorescence from the lumen 118 is attenuated relative to the threshold image ( Figure 4A )). Thus, the system 100 can compare Figure 4A , Figure 4B 's images to determine the differences and diagnose the biofilm within the lumen.

[0080] Figure 4C Shows a schematic image of the catheter fitting 112 with a distal lumen biofilm deposit 170. Since the distal lumen biofilm obstructs the reflected light / fluorescence from the lumen 118 and the catheter fitting wall and presents in a relatively uniform manner, the reflected light / fluorescence from the vessel wall 74 and blood is relatively unchanged, where the reflected light / fluorescence from the lumen 118 and the catheter fitting wall 112 is attenuated relative to the threshold image ( Figure 4A ). Thus, the system 100 can compare Figure 4A , Figure 4C 's images to determine the differences and diagnose the distal lumen biofilm.

[0081] Figure 4D Shows a schematic image of the catheter fitting 112 with an intraluminal blood clot deposit 170. Since the intraluminal blood clot only obstructs the reflected light / fluorescence from the lumen 118 and is concentrated in a specific area of the lumen 118, the reflected light / fluorescence from the vessel wall 74, blood, and the catheter fitting wall 112 is relatively unchanged, where the reflected light / fluorescence from a part of the lumen 118 is attenuated relative to the threshold image ( Figure 4A ). Thus, the system 100 can compare Figure 4A , Figure 4D 's images to determine the differences and diagnose the intraluminal blood clot.

[0082] Figure 4E Shows a schematic image of the catheter fitting 112 with a thrombus formation deposit 170. Since the thrombus formation deposit 170 is arranged on the outer surface of the catheter fitting 112, the deposit 170 obstructs the reflected light / fluorescence from the lumen 118 and the catheter wall and is concentrated in a specific area of the catheter fitting 112. Thus, the system 100 can compare Figure 4A , Figure 4Eof the image to determine differences and diagnose fibrin sheaths. The reflected light / fluorescence from the vessel wall 74 and the blood is relatively constant. However, if thrombosis extends to the wall of the vessel 74, resulting in mural thrombosis, or completely occludes the vessel 74, the reflected light from the vessel wall 74 and the blood will also be attenuated in a given area. Thus, the system 100 can compare Figure 4A , Figure 4D of the images to determine differences and diagnose thrombosis or mural thrombosis. These and other complications, structural abnormalities, etc. can be diagnosed in a similar manner.

[0083] Figure 5 FIG. shows a schematic diagram of the optical imaging system 130. In one embodiment, the optical imaging system 130 includes one or more processors 140, a memory 154, a data repository 150, logic modules (such as excitation light logic 142, signal light logic 144, image analysis logic 146, and communication logic 148), and hardware (such as a light source 132, a camera 134, a display 136 (e.g., a touchscreen display, etc.), a projector 138), a power supply 152, or a combination thereof. In one embodiment, the optical imaging system 130 is configured to provide an image based on the signal light 162 and / or the reflected light 164 detected by the camera 134. In one embodiment, the optical imaging system 130 can include a handheld device, a mobile device, a laptop computer, an augmented reality (AR) device, a virtual reality (VR) device, or a similar device configured to emit the excitation light 160 and detect the signal light 162 / reflected light 164 and provide an image.

[0084] In one embodiment, the excitation light logic 142 is communicatively coupled to the light source 132 and is configured to control the intensity and / or wavelength of the provided excitation light 160. In one embodiment, the signal light logic 144 is communicatively coupled to the camera 134 and is configured to control the characteristics of the camera 134 (e.g., aperture, exposure, etc.) and receive information regarding the detected signal light 162 and / or reflected light 164. In one embodiment, the image analysis logic 146 is communicatively coupled to the display 136 and / or the projector 138 and is configured to receive information from one or both of the excitation light logic 142 and the signal light logic 144 to provide an image of a portion of the VAD 110 and / or the surrounding tissue. In one embodiment, the image analysis logic 146 is communicatively coupled to the projector 138 and is configured to project an image onto the skin surface 70 of the patient. For example, an image of one or more of the VAD 110, the vasculature 74, and the surrounding tissue 72 is projected onto the skin surface 70, and the image is aligned with one or more of the VAD 110, the vasculature 74, and the surrounding tissue 72 disposed therebelow. The images provided on the display or projected onto the skin surface may include different colors or contrasts to facilitate visualization and differentiation of the different identified structures.

[0085] In one embodiment, the image analysis logic 146 is configured to analyze an image of the VAD 110 and / or compare the current image with a previous image stored in the data repository 150 to determine changes, such as changes that may indicate the presence of an occlusion, a deposit, a structural anomaly, or a similar complication described herein. In one embodiment, differences in the amount of received signal light 162 / reflected light 164 may be difficult to discern by a subjective evaluation of the displayed images. Accordingly, the optical imaging system 130 includes the image analysis logic 146, which is configured to measure one or more variables of an image (e.g., Figures 4B to 4E ) and compare the one or more variables with corresponding variables extracted from a historical or threshold image of the VAD 110 (e.g., Figure 4A ).

[0086] In one embodiment, the image analysis logic 146 includes one or more image recognition algorithms, a pre-determined rule set and weighting, machine learning patterns, artificial intelligence (AI) configured to parse the images received by the camera 134 and compare the information with threshold data to determine differences. For example, the image analysis logic 146 may parse an image into pixels, assign numerical values representing color and intensity to each pixel, and analyze the relative arrangement of each pixel within the image. In one embodiment, the image analysis logic 146 includes one or more sub-logic modules configured for image feature extraction, including but not limited to edge detection, boundary detection, color detection, object identification, and combinations thereof, etc.

[0087] The image analysis logic 146 and one or more sub-logic modules can analyze the parsed image to determine different EM radiation intensity patterns, wavelengths, etc. of the reflected light / fluorescence and their relationships with the surrounding pixel data to determine different boundaries, contours, shapes within the image and identify different tissues, structures, vasculature, fluids, blood, VAD structures (e.g., catheter fitting 112, lumen 118, etc.) within the image, and establish a baseline or threshold for each. Multiple threshold images can be used to establish differences in the image data that are not applicable to complications, which otherwise might be registered as false positives. Additional images including complications (such as deposits 170 and / or structural abnormalities) can indicate deviations in patterns, shapes, contours, intensities, and colors from the threshold images and can be used to diagnose different complications as described herein.

[0088] Threshold information can be determined from one or more baseline images of the VAD 110, different VADs from the same or different patients, or standardized image data. In one embodiment, multiple images of the same VAD 110 can be taken over a period of time. The historical images and / or threshold information of the VAD 110 can be stored in the data repository 150 and / or stored remotely and accessed via the communication logic 148 and the network 60. In one embodiment, the optical imaging system 130 displays changes in one or more variables (quantifiable changes) as a metric on the display 136 of the optical imaging system 130.

[0089] In one embodiment, the image analysis logic 146 can include one or more machine learning (ML) models, AI, etc. to determine the threshold information and determine changes in the image data that may indicate complications. For example, multiple labeled training data can be used to develop and train the ML model. The labeled training data can include multiple images of the VAD that do not include deposits 170 or structural disorders and include the identified and labeled tissue structures, blood, VAD structures (e.g., catheter fitting 112, lumen 118, etc.) Figure 4A ). Additionally, the labeled training data can include multiple images (e.g., Figures 4B to 4E ), the multiple images including different deposits 170 having different shapes, contours, and different effects on the reflected light / fluorescence as described herein. The training data can be stored locally on the data repository 150 or accessed remotely via the communication logic 148 and the network 60. Once trained, images from the signal light logic 144 can be provided to the model to determine the presence of any deposits 170 and / or structural disorders. Then, the system 100 can provide on the display 136 / projector 138 images of the VAD 110 and any deposits 170 and / or structural disorders identified by the image analysis logic 146.

[0090] In one embodiment, the system 100 can provide a warning to the user to indicate that a structural anomaly or deposit has been detected. The warning can be a visual, auditory, and / or tactile warning. In one embodiment, the system 100 can provide an indication of the type of detected structural anomaly or deposit, e.g., catheter kinking, collapse, biofilm, distal lumen membrane, thrombosis, mural thrombosis, etc. In one embodiment, the system 100 can also request input from the user (e.g., visual, auditory, or tactile input) to confirm that the deposit 170 and / or structural aberration identified by the image analysis logic 146 is correct. This input can be returned to the model as training data to further refine the accuracy of the model.

[0091] Advantageously, the VAD monitoring system 100 provides an effective means of repeatedly imaging the in-situ VAD 110 without exposing the patient or technician to repeated levels of harmful radiation (such as found in fluoroscopic imaging). These images can provide clearer images relative to ultrasound imaging and can be used to study the early onset of deposits on the VAD 110 without disturbing the VAD 110. This can provide valuable insights into the causes and indicators of deposit 170 formation leading to the various VAD complications described herein.

[0092] In one embodiment, the image analysis logic 146 of the optical imaging system 130 is configured to analyze images of the VAD 110, measure one or more variables, and determine the presence of and distinguish between the complications described herein, such as infiltration, extravasation, displacement, occlusion, loss of patency, infection, catheter kinking, catheter migration, thrombosis, phlebitis, biofilm, fibrin sheath, intraluminal thrombosis, distal intraluminal thrombosis disposed on the catheter fitting, etc.

[0093] Continuing to refer Figure 1A , in one embodiment, the external portion of the VAD 110 (e.g., the proximal portion of the catheter fitting 112, the catheter bushing 114, the dressing 116) can include one or more fiducial markers 128 configured to facilitate alignment of the optical imaging system 130 relative to the catheter fitting 112 disposed within the patient in three-dimensional space.

[0094] It should be understood that in the case where the difference between the received signal light 162 / reflected light 164 is very small, changes in the positions of the light source 132 and the camera 134 of the optical imaging system 130 can affect the results when comparing the image with the baseline image. For example, when the optical imaging system 130 is positioned further away from the skin surface 70, the excitation light 160 and / or the signal light 162 / reflected light 164 can exhibit greater attenuation relative to a closer position. Such attenuation can be misinterpreted as the presence of deposits 170.

[0095] As Figure 1A shown, in one embodiment, the dressing 116 includes fiducial markers 128. Once the VAD 110 has been placed subcutaneously and the dressing 116 is aligned with the insertion site 90 or the external portion of the VAD 110, the fiducial markers 128 are aligned with a portion of the catheter fitting 112 disposed thereunder. The fiducial markers 128 can be used to align the light source 132 and / or the camera 134 of the optical imaging system 130 with the catheter fitting 112 to ensure that the optical imaging system 130 is aligned with and at the same distance from the catheter fitting 112 each time an image is recorded.

[0096] In one embodiment, the light source 132 and the camera 134 of the optical imaging system 130 can be included in the same device. In one embodiment, the light source 132 and the camera 134 of the optical imaging system 130 can be provided as separate, independent devices. For example, as Figure 1A shown, the light source 132 is provided as a first device, and the camera 134 and the display 136 are provided as a second device separate from the first device. In one embodiment, the camera 134 and the display 136 can be provided as a handheld device (such as a smartphone) or a similar mobile device. In one embodiment, the camera 134 and the display 136 can be provided as an AR or VR device or a similar wearable device. Advantageously, the user can manipulate the position and orientation of the excitation light 160 emitted from the light source 132 relative to the camera 134 to achieve an unobstructed path for the signal light 162. In one embodiment, the light source 132 can be aligned with a first fiducial marker 128A, and the camera 134 can be aligned with a second fiducial marker 128B to ensure that the relative positioning of the separate light source 132 and camera 134 is consistent while still allowing the user to modify the angle of attack of the excitation light 160 to provide an unobstructed path for the signal light 162 / reflected light 164.

[0097] In one embodiment, the light source 132 and the camera 134 are included in a single device, and thus, the relative position and orientation can be pre-determined and fixed in place. Advantageously, this can reduce user error in the relative positioning of the light source 132 and the camera 134. In one embodiment, one or both of the light source 132 and the camera 134 include a rangefinder system or a similar device configured to determine the distance between the light source 132 / camera 134 and the skin surface 70. Thus, the optical imaging system 130 can indicate to the user what the distance is between the light source 132 / camera 134 and the skin surface 70, and whether the light source 132 / camera 134 is at a pre-determined or preferred distance from the skin surface 70.

[0098] In one embodiment, the light source 132 is included with a portion of the VAD 110. For example, the dressing 116 may include the light source 132 substantially located Figure 1A at the fiducial marker 128. The light source 132 may be supported against the skin surface, near the insertion site and aligned to direct the excitation light 160 down onto the skin surface 70. For example, as Figure 1A shown, the light source 132 may be located at the fiducial marker 128 and provide an illumination ring within which the camera 134 can be aligned. Advantageously, the light source 132 remains in a fixed position relative to the catheter fitting 112. In one embodiment, the VAD 110 (e.g., the dressing 116) may include a power source to supply power to the light source 132 included therein. In one embodiment, the power source may be included with an external device (e.g., the camera 134) and may supply power to the light source 132 by means of contact electrodes, induction, or similar suitable means.

[0099] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may occur to those of ordinary skill in the art, and in a broader sense, these adaptations and / or modifications are also encompassed. Accordingly, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A vascular access device monitoring system, characterized in that: include: a vascular access device having a catheter tubing disposed distally and configured to be disposed subcutaneously, the catheter tubing including a dye; and An optical imaging system, the optical imaging system comprising: a light source configured to emit excitation light; and A camera is configured to detect signal light emitted from the dye when the dye is exposed to the excitation light.

2. The vascular access device monitoring system according to claim 1, characterized in that: The excitation light comprises electromagnetic radiation in the range of 700 nm to 1 mm.

3. The vascular access device monitoring system according to claim 1, characterized in that: The excitation light comprises electromagnetic radiation in the range of 700 nm to 2500 nm.

4. The vascular access device monitoring system according to claim 1, characterized in that: The dye is integrally formed with the wall of the catheter tubing.

5. The vascular access device monitoring system according to claim 1, characterized in that: The dye is included in a coating disposed on a surface of the catheter tubing.

6. The vascular access device monitoring system according to claim 1, characterized in that: The excitation light has a first wavelength range, and the signal light has a second wavelength range different from the first wavelength range.

7. The vascular access device monitoring system according to claim 1, characterized in that: The vascular access device also includes a dressing configured to adhere to a skin surface of a patient and includes a fiducial 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. The vascular access device monitoring system according to claim 1, characterized in that: The light source and the camera are provided as a single handheld device.

9. The vascular access device monitoring system according to claim 1, characterized in that: The light source and the camera are provided as different independent devices.

10. The vascular access device monitoring system according to claim 7, characterized in that: The light source is included on the dressing.

11. A medical device imaging system, characterized in that: include: a medical device having a catheter tube and including a distal portion disposed within a blood vessel, the catheter tube including a dye included with the distal portion of the catheter tube disposed within the blood vessel; and An optical imaging system is arranged externally and includes a light source for emitting excitation light to illuminate the dye and a camera for detecting signal light emitted from the dye of the distal portion to provide an image so as to determine the shape of the distal portion of the medical device and the presence of structural abnormalities or deposits.

12. The medical device imaging system according to claim 11, characterized in that: The excitation light comprises electromagnetic radiation in the infrared or near infrared range.

13. The medical device imaging system according to claim 11, characterized in that: The dye is formed integrally with the wall of the catheter tubing or is included in a coating disposed on a surface of the catheter tubing.

14. The medical device imaging system according to claim 11, characterized in that: The excitation light has a first wavelength range, and the signal light has a second wavelength range different from the first wavelength range.

15. The medical device imaging system according to claim 11, characterized in that: The medical device also includes a dressing configured to adhere to a skin surface of a patient, and includes a fiducial marker configured to align one or both of the light source and the camera with the distal portion of the catheter tube disposed subcutaneously therebelow.

Images