Vascular access device monitoring system and medical device imaging system

Abstract

The invention relates to a vascular access device monitoring system and a medical device imaging system. A vascular access device (VAD) monitoring system includes a VAD having a catheter tubing disposed subcutaneously and incorporating a fluorescent dye. The optical imaging system includes a light source emitting infrared (IR) excitation light and a camera capable of detecting signal light emitted by the fluorescent dye when exposed to the excitation light. This enables real-time monitoring of VAD, allowing detection of any potential complications or problems associated with vascular access devices. The combination of the catheter tubing with a fluorescent dye and an optical imaging system provides a non-invasive efficient means of monitoring VAD, thereby enhancing patient safety and improving overall care outcomes.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 530,003, filed on July 31, 2023, which is incorporated in its entirety into this application. Technical Field

[0003] The present application relates to the field of medical devices, and more specifically to a vascular access device monitoring system and a medical device imaging system. Background Art

[0004] Briefly summarized, embodiments of the present invention relate to systems and methods for placing and monitoring subcutaneous implantable medical devices by optical imaging. During the placement of subcutaneous implantable medical devices (such as catheters and / or ports) and / or during their service life or residence time, various complications may occur. Exemplary complications caused include distal end dislocation, missing target vessels, entering incorrect vessels, back wall perforation (backwalling), distal end placement near valve or bifurcation, infiltration, extravasation, displacement, occlusion, loss of patency, infection, catheter collapse, catheter kink, catheter movement, thrombosis, phlebitis, etc. Further local changes in patient physiology can further affect the functional residence time of medical devices, for example, vein or artery size changes, collapse, sclerosis, damage, etc. can cause further complications. Without interfering with the placement of medical devices, it may be difficult to diagnose such complications. Typically, due to false positive diagnosis of the problem, such devices are removed prematurely. Alternatively, such complications may not be detected, thereby causing treatment efficacy to decrease or patient morbidity to increase.

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

[0006] Therefore, there is a need for a system and method for assessing 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 an indwelling VAD to a previous status, or to an established standard of care, to predict and identify VAD-related complications. Such a system is important in both acute care and alternate care settings to reduce patient complications and experience, reduce clinician burden, and improve the overall effectiveness of patient management and care. Summary of the invention

[0007] In some aspects, the technology described herein relates to a vascular access device (VAD) monitoring system comprising: a VAD having a catheter tubing disposed distally and configured to be disposed subcutaneously, the catheter tubing comprising a dye; and an 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.

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

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

[0010] In some aspects, the technology described herein relates to a VAD monitoring system in which a dye is integrally formed with the wall of a catheter tubing.

[0011] In some aspects, the technology described herein relates to a VAD monitoring system in which a dye is included in a coating disposed on a surface of a catheter tubing.

[0012] In some aspects, the technology described herein relates to a VAD monitoring system in which 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 technology described herein relates to a VAD monitoring system, wherein the VAD also 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.

[0014] In some aspects, the technology described herein relates to a VAD monitoring system in which a light source and a 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 distinct, independent devices.

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

[0017] In some aspects, the technology described herein relates to a VAD monitoring system, wherein an optical imaging system includes excitation light logic, signal light logic, and image analysis logic, wherein the image analysis logic is configured to analyze signal light detected by a 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 an optical imaging system.

[0019] In some aspects, the technology described herein relates to a VAD monitoring system in which an optical imaging system determines a quantified change in signal light and displays the quantified change as a metric on a display of the optical imaging system.

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

[0021] In some aspects, the technology described herein relates to a method for detecting complications associated with a vascular access device (VAD) disposed within a patient's body, comprising: providing excitation light to the patient's skin surface; irradiating the excitation light onto a dye, the dye being included with a subcutaneously disposed catheter tubing of the VAD; emitting signal light from the dye; detecting the signal light by a camera disposed outside the patient's body; 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 technology described herein relates to a method further comprising providing excitation light in the infrared (IR) or near infrared (NIR) spectrum.

[0023] In some aspects, the technology described herein relates to a method in which a dye is integrated into the wall of a catheter tubing.

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

[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 technology described herein relates to a method wherein the complication includes one or more of: occlusion, thrombosis, distal lumen biofilm, intraluminal biofilm, fibrin sheath, catheter tubing displacement, loss of patency of the catheter tubing, catheter tubing collapse, damage to the catheter tubing, proximity of the distal tip of the catheter tubing to a vascular valve, and proximity of the distal tip of the catheter tubing to a vascular bifurcation.

[0027] In some aspects, the technology described herein relates to a medical device imaging system, comprising: a medical device having a catheter tube and including a distal portion disposed within a blood vessel, the catheter tube 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 in a non-transitory storage medium, the one or more logic modules performing operations when executed by one or more processors, the operations comprising: emitting excitation light from the light source to illuminate the dye, the dye being included together with the distal portion of the catheter tube 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 analyzing the parsed image against threshold data to determine the presence of structural abnormalities or deposits.

[0028] In some aspects, the technology described herein relates to a medical device imaging system in which the excitation light includes electromagnetic radiation in the infrared or near infrared range.

[0029] In some aspects, the technology described herein relates to a medical device imaging system in which a dye is formed integrally with a wall of a catheter tubing or is included in a coating disposed on a surface of the catheter tubing.

[0030] In some aspects, the technology described herein relates to a medical device imaging system in which excitation light has a first wavelength range and signal light has a second wavelength range different from the first wavelength range.

[0031] In some aspects, the technology described herein relates to a medical device imaging system, wherein 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 a light source and a camera with a distal portion of a catheter tube disposed subcutaneously therebelow.

[0032] In some aspects, the technology described herein relates to a medical device imaging system, wherein analyzing the parsed images against threshold data also includes training a machine learning model using multiple labeled images, and the trained machine learning model is configured to determine structural abnormalities or deposits disposed on the medical device and provide an alert to a user.

[0033] In some aspects, the technology described herein relates to a medical device imaging system, wherein a plurality of labeled images include: labeled images of the medical device including deposits, labeled images of the medical device including structural abnormalities, and labeled images of the medical device without deposits or structural abnormalities. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] A more specific description of the disclosure will be presented by reference to specific embodiments of the disclosure illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and, therefore, should not be considered as limiting the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional particularity and detail through the use of the accompanying drawings, in which:

[0035] Figure 1A A perspective view of a vascular access device (VAD) monitoring system is shown in accordance with embodiments disclosed herein.

[0036] Figure 1B The embodiment disclosed herein is shown Figure 1A A perspective view of a first VAD coupled to a second VAD.

[0037] Figure 1C The embodiment disclosed herein is shown Figure 1B Close-up detail of the distal end segment of the device.

[0038] Figure 2A A perspective cross-sectional view of the distal tip of a VAD disposed within a vessel proximate a valve is shown in accordance with embodiments disclosed herein.

[0039] Figure 2B A perspective cross-sectional view of a distal tip of a VAD disposed within a vessel near a bifurcation is shown in accordance with embodiments disclosed herein.

[0040] Figure 2C A schematic side view of a distal portion of a catheter tube disposed within a vessel is shown according to embodiments disclosed herein.

[0041] Figure 2D The embodiment disclosed herein is shown Figure 2C Schematic plan view of a distal portion of a catheter tube arranged subcutaneously and imaged by an optical imaging system.

[0042] Figure 3A A schematic side view of a portion of a catheter tubing disposed subcutaneously and including one or more deposits is shown according to embodiments disclosed herein.

[0043] Figure 3B The embodiment disclosed herein is shown Figure 3A Schematic plan view of a catheter tube imaged by an optical imaging system.

[0044] Figure 4A A schematic plan view of a catheter tube imaged by an optical imaging system and free of any deposits or structural deformations is shown according to embodiments disclosed herein.

[0045] FIG. 4B to FIG. 4E The embodiment disclosed herein is shown Figure 4A A schematic plan view of a catheter tube imaged by an optical imaging system and including one or more complications.

[0046] Figure 5 A schematic diagram of an optical imaging system according to embodiments disclosed herein is shown. DETAILED DESCRIPTION

[0047] 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 may be optionally combined with or replace the features of any of the many other embodiments disclosed herein. It should be understood that the drawings are schematic and schematic representations of exemplary embodiments of the present invention, and are neither limited nor necessarily drawn to scale.

[0048] About the terms used herein, it should also be understood that these terms are for the purpose of describing some 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 set of features or steps, and do not provide sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "back", etc. are used, and these labels are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation or direction. The singular form of "a kind of", "one" and "the" includes plural references unless the context clearly stipulates otherwise. In addition, the words "comprise", "have" and "contain" as used herein (including claims) should have the same meaning as the word "comprise".

[0049] In the following description, the terms "or" and "and / or" as used herein should be interpreted as inclusive or meaning any one 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 will only occur if the combination of elements, parts, functions, steps or actions are inherently mutually exclusive in some way.

[0050] With respect to "proximal", for example, the "proximal portion" or "proximal end portion" of a catheter or system disclosed herein includes a portion of a catheter or system intended to be placed near a clinician or relatively closer to a clinician when the catheter or system is used for a patient. Similarly, for example, the "proximal length" of a catheter or system includes a length of a catheter or system intended to be placed near a clinician or relatively closer to a clinician when the catheter or system is used for a patient. For example, the "proximal end" of a catheter or system includes an end of a catheter or system intended to be placed near a clinician or relatively closer to a clinician when the catheter or system is used for a patient. The proximal portion, proximal portion, or proximal length of a catheter or system may include the proximal end of a catheter or system; however, the proximal portion, proximal portion, or proximal length of a catheter or system does not need to include the proximal end of a catheter or system. That is, unless the context otherwise indicates, the proximal portion, proximal portion, or proximal length of a catheter or system is not necessarily the terminal portion or terminal length of a catheter or system.

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

[0052] The term "logic" may refer to hardware, firmware, or software configured to perform one or more functions. As hardware, the term "logic" may refer to or include circuits having data processing and / or storage functions. Examples of such circuits may include, but are not limited to or constrained to, hardware processors (e.g., microprocessors, one or more processor cores, digital signal processors, programmable gate arrays, microcontrollers, application specific integrated circuits "ASICs", etc.), semiconductor memories, or combinational components.

[0053] Additionally or alternatively, the term "logic" may 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 servlet, a routine, a source code, an object code, a shared library / dynamic link library (dll), or even one or more instructions. The software may be stored in any type of suitable non-transitory storage medium or transient storage medium (e.g., an electrical, optical, acoustic, or other form of propagating signal, such as a carrier wave, an infrared signal, or a digital signal). Examples of non-transitory storage media may include, but are not limited to or limited 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-powered RAM, flash memory, phase change memory, etc.), a solid-state drive, a hard drive, an optical drive, or a portable memory device. As firmware, the logic may be stored in a persistent storage device.

[0054] To help describe the embodiments described herein, Figure 1A As shown, the longitudinal axis extends substantially parallel to the axial length of the catheter tube 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.

[0055] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0056] 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 may include, but are not limited to, single lumen catheters, multi-lumen catheters, midline catheters, intravenous 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.

[0057] In one embodiment, the VAD 110 includes a catheter tubing 112 that defines an inner cavity 118 and extends along a longitudinal axis. The catheter tubing 112 is supported by a catheter hub 114 at the proximal end. The catheter tubing 112 can be formed of a plastic, a polymer, an elastomer, a silicone rubber, a rubber, polymethyl methacrylate (PMMA) or a similar suitable material. The distal end of the catheter tubing 112 extends percutaneously into the patient's body to a target location at the insertion site 90. 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, but that various portions of the VAD 110 (or in some embodiments, the entire VAD 110) can be arranged subcutaneously. For example, when the VAD 110 includes a subcutaneous access port connected to a catheter, the entire VAD 110 can be arranged subcutaneously. In one embodiment, the VAD 110 can also include various numbers or combinations of catheter tubing, hubs, connectors, stabilizing wings, extension legs, auxiliary VADs, etc. connected thereto.

[0058] In one embodiment, VAD system 110 may further include a dressing 116 configured to adhere to a patient's skin surface and, optionally, to a portion of VAD 110. Dressing 116 may form a barrier over insertion site 90, thereby mitigating infection. In addition, dressing 116 may stabilize the portion of VAD 110 that is disposed outside the patient's body.

[0059] In one embodiment, if Figure 1B to Figure 1CAs shown, the system 100 can include a second VAD 210 coupled to the first VAD 110. For example, the first VAD 110 can be a PIV catheter that includes a first catheter tube 112A and provides access to a vascular system. The second VAD 210 can include a PIVO that is configured to couple with the hub 114 of the first VAD 110 and slide the second catheter tube 112B through the lumen 118 of the first catheter tube 112A to access the vascular system. In one embodiment, the second VAD 210 can be configured to engage the first VAD 110 to access the vascular system and draw a blood sample without having to puncture the vessel at a location separate from the first VAD 110.

[0060] In one embodiment, one or more portions of VAD 110 may include a dye 120 that is configured to reflect, absorb, and / or fluoresce when exposed to electromagnetic (EM) radiation, such as the infrared (IR) or near infrared (NIR) spectrum. However, it should be understood that the embodiments described herein may also utilize other EM spectra (e.g., optical or ultraviolet) having larger or smaller wavelengths. 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.

[0061] In one embodiment, the dye 120 is integrally formed with one or more portions of the VAD 110, e.g., with a polymer used to form the walls of the catheter tubing 112, the sleeve 114, etc. In one embodiment, the dye 120 is included in a coating disposed on a 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 tubing 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), combinations thereof, and the like. It should be understood that these dyes are exemplary and other dyes are also contemplated.

[0062] In one embodiment, the dye 120 is configured to reflect, transmit, and / or absorb EM radiation wavelengths differently than surrounding tissue or fluid. For example, the dye 120 can provide greater reflection, less transmission, and / or less absorption of EM radiation than blood, and provide less reflection, greater transmission, and / or greater absorption of EM radiation than vessel wall tissue. Thus, when visualized by the optical imaging system 130, the portion of the VAD 110 including the dye 120 appears more opaque than blood, but not as opaque as 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 blood, surrounding tissue, etc. are also contemplated.

[0063] In one embodiment, the dye 120 can be configured to fluoresce under EM radiation. For example, the dye 120 can be configured to absorb EM radiation at a first wavelength and, in response, emit EM radiation at a second wavelength different from the first wavelength. The second wavelength can be configured to be different from a reflected wavelength from surrounding tissue / blood in order to distinguish the VAD 110 or portions thereof from such surrounding tissue / fluids, as described herein.

[0064] In one embodiment, different concentrations of dye 120 can affect the amount of reflection, transmission, or absorption of EM radiation by VAD 110. For example, a relatively high concentration of dye 120 will provide a relatively high reflection of EM radiation and provide a relatively large reflection or absorption of EM radiation. Different colors of dye 120 can 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 dye particles 120 provide different reflective properties of EM radiation. For example, a smoother dye particle surface provides greater reflection of EM radiation relative to a rougher or more uneven dye particle surface. Finally, different fluorescent properties of dye 120 can provide different emission light properties. For example, dye 120 can 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 dye 120 may facilitate distinguishing dye 120 and associated structures of VAD 110 from surrounding tissue and fluid when imaged by optical imaging system 130 , as described herein.

[0065] Continue to refer Figure 1AIn one embodiment, system 100 further includes optical imaging system 130. Optical imaging system 130 is configured to emit excitation light 160, for example from light source 132, that is capable of penetrating the surface layers of skin 70, subcutaneous tissue 72, and vessel wall 74 to impinge on at least a portion of VAD 110. In other words, 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 skin 70, subcutaneous tissue 72, and vessel wall 74 to impinge on the subcutaneous portion of VAD 110. In one embodiment, excitation light 160 will be capable of penetrating the surface tissue of the skin to a depth of about 2 cm. However, greater or lesser depths are also contemplated.

[0066] In one embodiment, excitation light 160 from light source 132 is irradiated on VAD 110, dye 120, or a combination thereof, causing dye 120 to reflect, absorb, and / or fluoresce. The wavelength of reflected light 164 may be the same as or different from the wavelength of excitation light 160. In the case where dye 120 is configured to fluoresce, dye 120 absorbs excitation light 160 and emits signal light 162. Signal light 162 is the same as or different from excitation light 160. Optical imaging system 130 also includes a camera 134 or similar device configured to detect reflected light 164 and / or signal light 162.

[0067] FIG. 2A to FIG. 2D A schematic diagram of VAD 110 disposed within vessel 74 is shown. Figure 2A A perspective cross-sectional view of a distal portion of VAD 110 is shown extending through insertion site 90 on skin surface 70 to enter vessel 74 . Figure 2B A perspective cutaway view of a distal portion of VAD 110 is shown having a first catheter tube 112A and a second catheter tube 112B disposed within a lumen of first catheter tube 112A to access vessel 74 . Figure 2C A schematic side view of a portion of catheter tubing 112 disposed subcutaneously within vessel 74 is shown. Figure 2D A schematic plan view of a portion of catheter tubing 112 disposed subcutaneously and imaged by optical imaging system 130 is shown.

[0068] The dye 120 disposed in the VAD 110 or in a coating disposed on the VAD 110 is configured to reflect, transmit, absorb, and / or fluoresce to distinguish the VAD 110 from surrounding tissue and fluid. Figure 2AAs shown, the first excitation light 160A from the light source 132 can be transmitted through certain tissues (e.g., blood) or absorbed by them. The second excitation light 160B can be transmitted through some tissues (e.g., skin surface tissue 70, subcutaneous tissue 72) and reflected by the dye 120 in the catheter tube 112 as 162B. The third excitation light 160C can be transmitted through some tissues (e.g., skin surface tissue 70) and reflected by other tissues (e.g., 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 wavelengths or wavelength ranges different 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, which are reflected, transmitted, or absorbed differently based on the structure or fluid they illuminate. In one embodiment, the second catheter tube 112B can be configured to reflect light / fluoresce differently from the first catheter tube 112A. Thus, system 100 can distinguish between two or more VADs disposed within a blood vessel.

[0069] Advantageously, system 100 can facilitate visualization of placement of VAD 110, e.g., placement of the distal tip of catheter tubing 112 within vessel 74. System 100 can facilitate visualization of placement of catheter tubing 112 to ensure proper entry into vessel 74 and mitigate entry into an incorrect vessel, infiltration, extravasation, or posterior wall perforation. As used herein, the term "posterior wall perforation" includes extending a catheter through a first wall of vessel 74 to enter the vessel, and then traversing the posterior wall of vessel 74 such that the distal tip is placed outside of vessel 74.

[0070] Advantageously, system 100 can facilitate visualization of VAD 110 to prevent placement of the distal tip of catheter tube 112 near valve 76. Figure 2A As shown, because system 100 can distinguish between blood, vascular tissue 74, and VAD 110, system 100 can identify whether the distal tip of catheter tube 112 is positioned near valve 76. If placed too close to valve 76, when blood is drawn from vessel 74, the pressure may cause valve 76 to close, thereby preventing more blood from being drawn, or may cause damage to valve 76 itself. Advantageously, as shown in FIG. Figure 2B As shown, system 100 can identify whether the distal tip of catheter tubing 112 (eg, first catheter tubing 112A) is disposed proximate bifurcation 78. Aspirating blood from a bifurcation can cause retrograde blood flow through vessel 74, causing discomfort to the patient and leading to complications.

[0071] like Figure 2CAs shown, the dye 120 is substantially uniformly included throughout the material forming the wall of the catheter tube 112. Alternatively or additionally, the dye 120 is substantially uniformly included throughout the coating disposed on the surface of the catheter tube 112. When the excitation light 160 penetrates the skin surface 70 and the surface tissue 72 and irradiates the catheter tube 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, thereby allowing the catheter tube 112 to be imaged.

[0072] The optical imaging system 130 using EM radiation provides high resolution images of the subcutaneous portion of the VAD 110 in contrast to surrounding tissues and structures relative to other imaging modalities (e.g., fluoroscopy, ultrasound, etc.). It is noted that different compositions of subcutaneous structures will reflect and absorb excitation light 160 differently, thereby allowing imaging of these structures (e.g., blood vessels, muscle, dermis, etc.) relative to the VAD 110 that fluoresces and / or reflects differently, 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, dislocation, or kinking of the VAD 110.

[0073] like Figure 2D As shown, in one embodiment, when viewed from above, the relative concentration of dye 120 is greater toward the lateral sides of catheter tubing 112 (i.e., the edges of catheter tubing 112) relative to the central portion of catheter tubing 112. Thus, the edges of catheter tubing 112 appear "brighter" relative to the central lumen 118 of catheter tubing 112 because the signal light 162 / reflected light 164 is relatively greater at these portions. Thus, the structure of catheter tubing 112 can be discerned in the image provided by optical imaging system 130. Advantageously, optical imaging system 130 can detect any misalignment or structural abnormalities of catheter tubing 112 when placed subcutaneously, such as twisting or kinking.

[0074] For example, incorrect placement of the catheter tubing 112 can cause a variety of problems. In the event that the distal tip is unable to enter the vessel or breaks through the far wall of the vessel 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 imaged in advance using the system 100. When the patient returns for a repeat treatment, the placement of the VAD 110 can be confirmed before the treatment is started to ensure that the VAD 110 has not moved or shifted during the transition period between placement and treatment. In addition, the clinician can confirm the integrity of the VAD device before starting the treatment to ensure that no damage or kinking has occurred.

[0075] Figure 3A A schematic side view of a portion of catheter tubing 112 disposed subcutaneously and including one or more deposits 170 disposed thereon is shown. Figure 3B Shows Figure 3A 1 is a schematic plan view of a catheter tube 112 when imaged by an optical imaging system 130. One or more deposits 170 may include a biofilm, a fibrin sheath, a thrombus formation, a blood clot, etc. The deposits 170 may be formed regularly or irregularly on the outer surface of the catheter tube 112, or formed within the catheter lumen 118, for example, formed on the inner surface of the catheter lumen 118.

[0076] The deposits 170 affect 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 shown in FIG. Figure 3B As shown, it can affect the "brightness" or contrast of catheter tubing 112 relative to surrounding tissue when imaged by optical imaging system 130. For example, as shown, deposits 170 appear as contrasting "darker" areas on the image of catheter tubing 112. The effect of deposits 170 on dye 120 can provide unique patterns and / or contrast differences that can be used to diagnose various complications described herein.

[0077] FIG. 4A to FIG. 4E Exemplary images of a VAD 110 deployed within a blood vessel are shown, along with various complications that may be diagnosed based on the differential reflection / emission of EM radiation detected by the system 100 . Figure 4A A schematic image of a catheter tubing 112 without any deposits 170 or structural deformation is shown. As shown, the vessel wall 74 reflects differently from the blood in the vessel 74. The catheter tubing 112 also fluoresces / reflects differently from either the vessel wall and the blood to distinguish from the two. As the material depth increases, the dye 120 is more concentrated at the edge of the catheter tubing 112, so the wall of the catheter tubing 112 can be distinguished from the lumen 118. Therefore, the system 100 can determine that the lumen 118 does not have deposits 170, occlusion or structural deformation, as described herein. Optionally, the system 100 can use such images as baseline or threshold images. Baseline or threshold images can be established from images of the VAD 110 shortly after placement, from multiple images of the VAD 110 over time, or from pre-determined nursing standard images stored locally or remotely.

[0078] Figure 4B1 shows a schematic image of a catheter tubing 112 having an intraluminal biofilm deposit 170. Since the intraluminal biofilm only blocks reflected light / fluorescence from the lumen 118 and in a relatively uniform manner along the lumen 118, the reflected light / fluorescence from the vessel wall 74, blood, and the catheter tubing wall 112 is relatively unchanged, wherein the reflected light / fluorescence from the lumen 118 is relatively constant relative to the threshold image ( Figure 4A ) is somewhat attenuated. Therefore, the system 100 can be compared Figure 4A , Figure 4B images to identify differences and diagnose intraluminal biofilm.

[0079] Figure 4C 1 shows a schematic image of a catheter tubing 112 having a distal lumen biofilm deposit 170. Because the distal lumen biofilm blocks reflected light / fluorescence from the lumen 118 and the catheter tubing wall in a relatively uniform manner, reflected light / fluorescence from the vessel wall 74 and blood is relatively unchanged, wherein reflected light / fluorescence from the lumen 118 and the catheter tubing wall 112 is relatively constant relative to the threshold image ( Figure 4A ) is somewhat attenuated. Therefore, the system 100 can be compared Figure 4A , Figure 4C images to identify differences and diagnose distal luminal biofilm.

[0080] Figure 4D 170. A schematic image of a catheter tubing 112 having an intraluminal blood clot deposit 170 is shown. Since the intraluminal blood clot only blocks 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 tubing wall 112 is relatively unchanged, wherein the reflected light / fluorescence from a portion of the lumen 118 is relatively unchanged relative to the threshold image ( Figure 4A ) is somewhat attenuated. Therefore, the system 100 can be compared Figure 4A , Figure 4D images to determine the difference and diagnose intracavitary blood clots.

[0081] Figure 4E 1 shows a schematic image of a catheter tubing 112 having thrombotic deposits 170. Since the thrombotic deposits 170 are disposed on the outer surface of the catheter tubing 112, the deposits 170 block reflected light / fluorescence from the lumen 118 and the catheter wall and are concentrated in a specific area of ​​the catheter tubing 112. Thus, the system 100 can be relatively Figure 4A , Figure 4EThe image of the fibrin sheath can be used to determine the difference and diagnose the fibrin sheath. The reflected light / fluorescence from the vessel wall 74 and blood is relatively unchanged. However, if the thrombosis extends to the wall of the vessel 74, thereby producing a mural thrombosis, or completely occludes the vessel 74, the reflected light from the vessel wall 74 and blood will also be attenuated in a given area. Therefore, the system 100 can compare Figure 4A , Figure 4D Images of the CT scan can be taken to determine the difference and diagnose thrombosis or mural thrombosis. These and other complications, structural abnormalities, etc. can be diagnosed in a similar manner.

[0082] Figure 5 A schematic diagram of an optical imaging system 130 is shown. 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 touch screen 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 may 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 excitation light 160 and detect the signal light 162 / reflected light 164 and provide an image.

[0083] 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 excitation light 160 provided. In one embodiment, the signal light logic 144 is communicatively coupled to the camera 134 and is configured to control features of the camera 134 (e.g., aperture, exposure, etc.) and receive information about 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 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 patient's skin surface 70. For example, an image of one or more of the VAD 110, the vessel 74, and the surrounding tissue 72 is projected onto the skin surface 70, the image being aligned with the one or more of the VAD 110, the vessel 74, and the surrounding tissue 72 disposed thereunder. The image provided on the display or projected onto the skin surface may include different colors or contrasts to facilitate visualization and differentiation of the different structures identified.

[0084] In one embodiment, the image analysis logic 146 is configured to analyze images of the VAD 110 and / or compare current images to previous images stored to the data repository 150 to determine changes, for example, changes that may indicate the presence of an occlusion, deposit, structural abnormality, or similar complication described herein. In one embodiment, differences in the amount of received signal light 162 / reflected light 164 may be difficult to discern through subjective assessment of the displayed image. Accordingly, the optical imaging system 130 includes image analysis logic 146 that is configured to measure images (e.g., FIG. 4B to FIG. 4E ) and compare the one or more variables to the historical or threshold images from the VAD 110 (e.g., Figure 4A ) to compare the corresponding variables extracted.

[0085] In one embodiment, the image analysis logic 146 includes one or more image recognition algorithms, predetermined rule sets and weightings, machine learning models, artificial intelligence (AI) configured to parse images received by the camera 134 and compare the information to threshold data to determine differences. For example, the image analysis logic 146 can parse the image into pixels, assign a numerical value 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, and the one or more sub-logic modules are configured for image feature extraction, including but not limited to edge detection, boundary detection, color detection, object identification, and combinations thereof, etc.

[0086] The image analysis logic 146 and one or more sub-logic modules can analyze the parsed images to determine different EM radiation intensity patterns, wavelengths, etc. of reflected light / fluorescence and their relationship to surrounding pixel data to determine different boundaries, contours, shapes within the image and identify different tissues, structures, vessels, fluids, blood, VAD structures (e.g., catheter tubing 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 do not apply to complications, which otherwise may be registered as false positives. Additional images that include complications (such as deposits 170 and / or structural abnormalities) can indicate deviations in pattern, shape, contour, intensity, and color from the threshold image and can be used to diagnose different complications, as described herein.

[0087] Threshold information may 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 may be taken of the same VAD 110 over a period of time. Historical images and / or threshold information for the VAD 110 may be stored in a 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 the change (quantifiable change) in one or more variables as a metric on a display 136 of the optical imaging system 130.

[0088] In one embodiment, the image analysis logic 146 may include one or more machine learning (ML) models, AI, etc. to determine threshold information and identify changes in the image data that may indicate complications. For example, a plurality of labeled training data may be used to develop and train the ML model. The labeled training data may include a plurality of images of the VAD that do not include deposits 170 or structural abnormalities and include identified and labeled tissue structures, blood, VAD structures (e.g., catheter tubing 112, lumen 118, etc.) Figure 4A ). In addition, the labeled training data may include multiple images (e.g., FIG. 4B to FIG. 4E ), the plurality of images include different deposits 170 having different shapes, contours, and different effects on reflected light / fluorescence, as described herein. The training data may be stored locally on the data repository 150, or accessed remotely via the communication logic 148 and the network 60. Once trained, the model may be provided with images from the signal light logic 144 to determine the presence of any deposits 170 and / or structural anomalies. The system 100 may then provide images of the VAD 110 and any deposits 170 and / or structural anomalies identified by the image analysis logic 146 on the display 136 / projector 138.

[0089] In one embodiment, system 100 can provide warning to the user to indicate that structural abnormality or deposit has been detected. Warning can be visual, auditory, and / or tactile warning. In one embodiment, system 100 can provide indication of the type of structural abnormality or deposit detected, for example, catheter kink, collapse, biofilm, far lumen membrane, thrombosis, wall thrombosis, etc. In one embodiment, system 100 can also request input (for example, visual, auditory, or tactile input) from the user to confirm that the deposit 170 and / or structural abnormality identified by image analysis logic 146 is correct. These inputs can be returned to the model as training data to further refine the accuracy of the model.

[0090] Advantageously, the VAD monitoring system 100 provides an effective means of repeatedly imaging an in situ deployed VAD 110 without exposing the patient or technician to repeated levels of harmful radiation, such as found in fluoroscopic imaging. These images may provide clearer images relative to ultrasound imaging and may be used to study the early onset of deposit formation on the VAD 110 without disturbing the VAD 110. This may provide valuable insight into the causes and indicators of deposit 170 formation leading to the various VAD complications described herein.

[0091] 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 and distinguish between 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 lumen thrombosis disposed on catheter tubing, and the like.

[0092] Continue to refer Figure 1A In one embodiment, an external portion of the VAD 110 (e.g., a proximal portion of the catheter tubing 112, the catheter hub 114, the dressing 116) can include one or more fiducial markers 128 configured to facilitate alignment of the optical imaging system 130 in three-dimensional space relative to the catheter tubing 112 disposed within the patient's body.

[0093] It should be understood that changes in the position of the light source 132 and camera 134 of the optical imaging system 130 can affect the results when comparing images to baseline images, if the differences in the received signal light 162 / reflected light 164 are very slight. For example, where the optical imaging system 130 is positioned farther away from the skin surface 70, the excitation light 160 and / or the signal light 162 / reflected light 164 can show greater attenuation relative to a closer position. Such attenuation can be misinterpreted as the presence of a deposit 170.

[0094] like Figure 1A As shown, in one embodiment, dressing 116 includes fiducial markers 128. Once VAD 110 has been placed subcutaneously and dressing 116 is aligned with insertion site 90 or an external portion of VAD 110, fiducial markers 128 are aligned with a portion of catheter tubing 112 disposed thereunder. Fiducial markers 128 may be used to align light source 132 and / or camera 134 of optical imaging system 130 with catheter tubing 112 to ensure that optical imaging system 130 is aligned with and at the same distance from catheter tubing 112 each time an image is recorded.

[0095] In one embodiment, the light source 132 and the camera 134 of the optical imaging system 130 may be included in the same device. In one embodiment, the light source 132 and the camera 134 of the optical imaging system 130 may be provided as different independent devices. Figure 1A As shown, the light source 132 is set as a first device, and the camera 134 and the display 136 are set as a second device separate from the first device. In one embodiment, the camera 134 and the display 136 can be set as a handheld device (such as a smart phone) or a similar mobile device. In one embodiment, the camera 134 and the display 136 can be set as an AR or VR device or a similar wearable device. Advantageously, the user can manipulate the position and direction of the excitation light 160 emitted from the light source 132 relative to the camera 134 to achieve a clear path for the signal light 162. In one embodiment, the light source 132 can be aligned with the first reference mark 128A, and the camera 134 can be aligned with the second reference mark 128B to ensure that the relative positioning of the separate light sources 132 and the camera 134 is consistent, while still allowing the user to modify the angle of attack of the excitation light 160 to provide a clear path for the signal light 162 / reflected light 164.

[0096] In one embodiment, the light source 132 and the camera 134 are included in a single device, and therefore, the relative position and orientation can be predetermined and fixed in place. Advantageously, this can reduce user errors 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. Therefore, the optical imaging system 130 can indicate to the user how far the light source 132 / camera 134 is from the skin surface 70, and whether the light source 132 / camera 134 is at a predetermined or preferred distance from the skin surface 70.

[0097] In one embodiment, light source 132 is included with a portion of VAD 110, for example, dressing 116 may include a light source 132 substantially located at Figure 1A The light source 132 may be supported against the skin surface, near the insertion site and aligned to direct the excitation light 160 downward onto the skin surface 70. For example, Figure 1A As shown, the light source 132 can be located at the fiducial marker 128 and provide an illuminated ring in which the camera 134 can be aligned. Advantageously, the light source 132 remains in a fixed position relative to the catheter tube 112. In one embodiment, the VAD 110 (e.g., the dressing 116) can include a power source to provide power to the light source 132 included therein. In one embodiment, the power source can be included with the external device (e.g., the camera 134), and the light source 132 can be powered by contact electrodes, induction, or similar suitable means.

[0098] 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 be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, 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. The vascular access device monitoring system according to claim 1, characterized in that: The optical imaging system includes excitation light logic, signal light logic, and image analysis logic configured to analyze the signal light detected by the camera and detect changes in the signal light relative to a threshold image.

12. The vascular access device monitoring system according to claim 11, characterized in that: The threshold image generated from one or more previous images of the vascular access device is generated by the optical imaging system.

13. The vascular access device monitoring system according to claim 11, characterized in that: The optical imaging system determines a quantitative change in the signal light and displays the quantitative change as a metric on a display of the optical imaging system.

14. The vascular access device monitoring system according to claim 11, characterized in that: The image analysis logic of the optical imaging system is configured to analyze the signal light, generate an image of the catheter tubing, and determine one or more of: occlusion, thrombosis, distal lumen biofilm, intraluminal biofilm, fibrin sheath, catheter tubing displacement, loss of patency of the catheter tubing, catheter tubing collapse, damage to the catheter tubing, proximity of the distal end of the catheter tubing to a vascular valve, or proximity of the distal end of the catheter tubing to a vascular bifurcation.

15. 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; and An optical imaging system disposed externally and comprising a light source, a camera, and a console, the console comprising one or more logic modules stored in a non-transitory storage medium, the one or more logic modules performing operations when executed by one or more processors, the operations comprising: emitting excitation light from the light source to illuminate the dye, the dye being included together with the distal portion of the catheter tube disposed within the blood vessel; detecting signal light emitted from the dye of the distal portion to provide an image; interpreting the image to determine a shape of the distal portion of the medical device; and The resolved images are analyzed against threshold data to determine the presence of structural anomalies or deposits.

16. The medical device imaging system according to claim 15, characterized in that: The excitation light comprises electromagnetic radiation in the infrared or near infrared range.

17. The medical device imaging system according to claim 15, 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.

18. The medical device imaging system according to claim 15, 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.

19. The medical device imaging system according to claim 15, 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.

20. The medical device imaging system according to claim 15, characterized in that: Analyzing the parsed image against the threshold data also includes: training a machine learning model using a plurality of labeled images, the trained machine learning model being configured to determine structural abnormalities or deposits disposed on the medical device and providing a warning to a user.

21. The medical device imaging system according to claim 20, characterized in that: The plurality of labeled images include labeled images of the medical device including deposits, labeled images of the medical device including structural abnormalities, and labeled images of the medical device without deposits or structural abnormalities.

Images