Bragg grating fiber optic wave sensing and monitoring system

Abstract

Systems, devices, and methods related to detecting damage to an optical fiber of a medical device are disclosed herein. The optical fiber includes a core fiber that includes a plurality of sensors configured to: (i) reflect a light signal based on received incident light, and (ii) change a characteristic of the reflected light signal based on experienced strain. The system also includes a console having a memory that stores logic that, when executed, causes: reception of the reflected light signal by one or more of the plurality of sensors of different spectral widths of broadband incident light, processing of the reflected light signal to detect a fluctuation of a portion of the optical fiber, and determination of a location of the portion of the optical fiber or a defect of a vessel in which the portion is disposed based on the detected fluctuation. The portion can be a distal tip of the optical fiber.

Description

[0001] Priority

[0002] This application claims priority benefit of U.S. Provisional Application No. 63 / 060,533, filed August 3, 2020, which is incorporated by reference in its entirety into the present application. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to a Bragg grated fiber optic wave sensing and monitoring system. BACKGROUND

[0004] In the past, certain intravascular guidance of medical devices, such as guide wires and catheters, have employed, for example, fluoroscopy methods to track the tip of the medical device and determine whether the distal tip is properly positioned in its target anatomical structure. However, such fluoroscopy methods expose the patient and their attending physician to harmful X-ray radiation. In addition, in some cases, the patient is exposed to potentially harmful contrast agents required by the fluoroscopy methods.

[0005] More recently, electromagnetic tracking systems involving stylets have been used. Generally, electromagnetic tracking systems feature three components: a field generator, a sensor unit, and a control unit. The field generator generates a position varying magnetic field for establishing a coordinate space using a plurality of coils. The sensor unit, which is attached to the stylet, such as near the distal end (tip) of the stylet, includes small coils in which an electric current is induced via the magnetic field. Based on the electrical properties of each coil, the position and orientation of the medical device can be determined within the coordinate space. The control unit controls the field generator and captures data from the sensor unit.

[0006] While electromagnetic tracking systems avoid line-of-sight dependency in tracking the tip of the stylet, while avoiding radiation exposure and potentially harmful contrast agents associated with fluoroscopy methods, electromagnetic tracking systems are susceptible to interference. More specifically, since electromagnetic tracking systems rely on the measurement of the magnetic field produced by the field generator, these systems experience electromagnetic field interference, which can be caused by the presence of many different types of consumer electronics, such as cellular phones. Additionally, electromagnetic tracking systems experience signal loss, rely on external sensors, and are limited to a finite depth range.

[0007] This document discloses a fiber optic shape sensing system and execution method, wherein the system is configured to provide confirmation, tracking information, and / or vascular defect detection using fiber optic technology. Additionally, the system is configured to detect fluctuations in a portion of a body via one or more core fibers, and to confirm the location within the patient's vascular system and / or detect defects affecting the vessels (e.g., vascular constriction, vasospasm, vascular occlusion, etc.). In some embodiments, a portion of the fiber optic cable may be a distal tip. Some embodiments combine fiber optic shape sensing functionality with one or more of the following: electrocardiography (ECG) monitoring, impedance / conduction sensing, blood flow orientation detection, etc. Summary of the Invention

[0008] In short, the embodiments disclosed herein relate to systems, apparatus, and methods for measuring the undulation of the distal tip of a medical device (also known as the realized body) (such as a catheter, guidewire, or needle) via an optical fiber core during advancement through a patient's vascular system. The systems, apparatus, and methods may then further include correlating the tip undulation measurement with stored data (e.g., empirical knowledge of previously measured tip undulations) to confirm the location of the distal tip of the medical device or detect defects affecting the blood vessel. While the embodiments primarily discuss the measurement of the undulation of the distal tip of a medical device, this disclosure is not intended to limit it to such a specific part of the medical device. Rather, the embodiments and methods described herein regarding the distal tip can be applied to other parts of the medical device.

[0009] More specifically, in some embodiments, the medical device includes an optical fiber core configured with a sensor array (reflective grating) spatially distributed over a predetermined length of the core fiber to substantially sense external strain on the areas of the core fiber occupied by the sensors. The optical fiber core is configured to receive broadband light from a console during propagation through the patient's vascular system, wherein the broadband light propagates distally along at least a portion of the distance of the optical fiber core. With each sensor positioned along the same optical fiber core configured to reflect light of a different specific spectral width, the sensor array enables distributed measurements across a multi-core optical fiber of the predetermined length. These distributed measurements may include wavelength shifts correlated with the strain experienced by the sensors.

[0010] Reflected light from the sensors (reflective gratings) within the optical fiber core returns from the medical instrument for processing by the control console. The physical state of the medical instrument can be determined based on analysis of the wavelength shift of the reflected light. For example, strain caused by bending of the medical instrument and the resulting angular changes of the optical fiber core cause varying degrees of deformation. The varying degrees of deformation change the shape of the sensors (reflective gratings) positioned on the optical fiber core, which can cause a change (shift) in the wavelength of the reflected light from the sensors positioned on the optical fiber core. The optical fiber core can include a single optical fiber or multiple optical fibers (in which case the optical fiber core is referred to as a "multi-core optical fiber").

[0011] As used herein, the term "core fiber" generally refers to a single optical fiber core disposed within a medical device. Thus, discussion of a core fiber refers to a single optical fiber core, while discussion of a multi-core optical fiber refers to multiple core fibers. Various embodiments of detecting health (and in particular damage) occurring in each optical fiber core of a medical device are discussed below, which optical fiber core includes: (i) a single core fiber and (ii) multiple core fibers.

[0012] Specific embodiments of the disclosure include utilizing a medical instrument such as a stylet featuring a multi-core optical fiber and a conductive medium that collectively operate to track placement of the stylet or another medical device (such as a catheter) in which the stylet is disposed within a patient. A guide wire can be utilized in place of the stylet. For convenience, embodiments in which the optical fiber core is disposed within a stylet are generally discussed; however, the disclosure is not intended to be limited as such, as the functionality involving detecting health of the optical fiber cores disclosed herein can be implemented regardless of the medical device in which the optical fiber core is disposed.

[0013] In some embodiments, the optical fiber core of the stylet is configured to return information for identifying: (i) a portion of the stylet (e.g., a tip, a segment, etc. of the stylet) or a portion of a catheter that includes at least a portion of the stylet (e.g., a tip, a segment, etc. of the catheter); or (ii) a physical state (e.g., shape length, shape, and / or form) of all or a substantial portion of the stylet or the catheter within the patient (described below as "the physical state of the stylet" or "the physical state of the catheter"). According to one embodiment of the disclosure, the returned information can be obtained from reflected light signals of different spectral widths, where each reflected light signal corresponds to a portion of a broadband incident light propagating along a core (hereinafter "core fiber") of the multi-core optical fiber that is reflected back over the core fiber by a particular sensor located on the core fiber. One illustrative example of the returned information can involve a change in a signal characteristic of the reflected light signal returned from the sensor, where a wavelength shift is related to a (mechanical) strain on the core fiber.

[0014] In some embodiments, the core fibers utilize multiple sensors and each sensor is configured to reflect incident light of a different spectral range (e.g., a different range of light frequencies). Based on the type and extent of strain imparted on each core fiber, the sensor associated with that core fiber can shift (offset) the wavelength of the reflected light to communicate the type and extent of strain on that core fiber at those locations of the stylet occupied by the sensor. The sensors are spatially distributed at different locations of the core fibers between the proximal and distal ends of the stylet such that shape sensing of the stylet can be implemented based on analysis of the wavelength shifts. Here, the shape sensing functionality pairs with the ability to deliver electrical signals through the same member (stylet) by including a conductive medium that is part of the stylet.

[0015] More specifically, in some embodiments, each core fiber of the multicore optical fiber is configured with an array of sensors that are spatially distributed over a prescribed length of the core fiber to substantially sense external strain on those regions of the core fiber occupied by the sensors. With each sensor positioned along the same core fiber configured to reflect light of a different particular spectral width, the array of sensors enables distributed measurements over the entire prescribed length of the multicore optical fiber. These distributed measurements can include wavelength shifts having a correlation to strain experienced by the sensors.

[0016] According to one embodiment of the disclosure, each sensor can operate as a reflective grating, such as a fiber Bragg grating (FBG), i.e., an intrinsic sensor corresponding to a permanent, periodic refractive index variation inscribed into the core fiber. In other words, the sensors operate as mirrors for light of a particular spectral width (e.g., a particular wavelength or a particular range of wavelengths). As a result, when broadband incident light is provided by an optical light source and propagates through a particular core fiber, once reaching a first sensor of the distributed array of sensors for that core fiber, the prescribed spectral width of light associated with the first sensor is reflected back to an optical receiver within a console that includes a display and the optical light source. The remaining spectrum of the incident light continues to propagate through the core fiber toward the distal end of the stylet. The remaining spectrum of the incident light can encounter other sensors from the distributed array of sensors, where each of these sensors is fabricated to reflect light having a different particular spectral width, in turn providing distributed measurements as described above.

[0017] During operation, multiple light reflections (also referred to as "reflected light signals") return from each of the multiple core fibers of the multicore optical fiber to the control console. Each reflected light signal can be uniquely associated with a different spectral width. Information associated with the reflected light signals can be used to determine a three-dimensional representation of the physical state of the stylet within the patient. Here, the core fibers are spatially separated from the cladding of the multimode optical fiber, and each core fiber is configured to return light of a different spectral width (e.g., a particular optical wavelength or range of optical wavelengths) reflected from a distributed sensor array fabricated in each core fiber, respectively. A comparison of the detected shifts in the wavelengths of the reflected light returned by the central core fiber (as a reference operation) and the peripheral peripheral core fibers can be used to determine the physical state of the stylet.

[0018] During vascular system insertion and catheter advancement, a clinician can rely on the control console to visualize the current physical state (e.g., shape) of the catheter guided by the stylet to avoid potential path deviations. As the peripheral core fibers are located at spatially different locations within the cladding of the multimode optical fiber, changes in the angular orientation of the stylet (such as bending relative to the central core fiber, etc.) impose different types (e.g., compression or stretching) and degrees of strain on each of the peripheral core fibers as well as the central core fiber. The different types and / or degrees of strain can cause the sensors of the core fibers to impose different wavelength shifts, which can be measured to infer the physical state of the stylet (catheter).

[0019] Embodiments of the disclosure can include one or more methods in combination to determine the location of the distal tip of an implemented subject (e.g., a guidewire, a wire, a stylet within a needle, a needle with an embedded cannulated optical fiber, a stylet configured for use with a catheter, an optical fiber between a needle and a catheter, and / or an optical fiber integrated into a catheter) and / or various defects of a patient's vessel through which the implemented subject is advanced. For example, some embodiments are directed to detection of the distal tip of an implemented subject advanced through a superior vena cava (SVC) toward the right atrium of a patient's heart, where the detection can be based at least in part on detecting fluctuations of the tip of the implemented subject and correlating with expected fluctuations caused by the rhythm of the heart. Other embodiments are directed to detecting defects in a vessel through which an implemented subject is advanced, detecting fluctuations of the tip of the implemented subject and correlating such expected fluctuations of the tip location of the implemented subject and / or known fluctuations of certain defects. Examples of defects that can be detected by embodiments described herein include, but are not limited to or limited to, vessel stenosis, vasospasm, and vessel occlusion.

[0020] For example, certain embodiments include logic configured to perform run-time analysis, heuristics, and / or machine learning techniques to correlate detected fluctuations of the distal tip of an implemented subject with previously detected tip fluctuations (e.g., empirical knowledge).

[0021] Other embodiments of the disclosure can include integration (as will be discussed below) with any combination of the following: electrocardiogram (ECG) signaling systems, ultrasound systems, fiber optic shape sensing technology, tip location technology, tip confirmation technology, impedance / conductance sensing, catheter advancement confirmation technology (e.g., where the fluctuations of the implemented body stop / change as the catheter tip advances over the body), blood pressure, and / or blood flow direction identification. It should be noted that embodiments containing a fiber optic core (which is advanced in or integrated with the implemented body) can be suitable for use with magnetic resonance imaging systems (and do not contain other detection systems).

[0022] In some embodiments, because the fiber optic is relatively flexible, the implemented body can be reinforced by, for example, one or more layers of reinforcing material or layered material, where such reinforcement can provide a degree of stiffness to the length of the implemented body. In some such embodiments, the amount of reinforcement can vary along the length of the implemented body, such that the degree of stiffness varies accordingly. For example, in one example embodiment, the amount of reinforcement provided can be a first amount for a first portion of the implemented body and a second, lesser amount for a second portion (e.g., where the second portion is the distal tip). In such an instance, the level of stiffness at the distal tip would be less than the level of stiffness for the rest of the length of the implemented body. Such an embodiment would provide greater flexibility at the distal tip, allowing for a greater range of motion motivated by blood flow, turbulence, etc. The greater range of motion can be measured by the fiber optic or other sensors as described herein. Thus, such an example embodiment can be more suitable for measuring motion at the distal tip of the implemented body as compared to embodiments having uniform stiffness along the length of the implemented body.

[0023] Additionally, the implemented body can include one or more protrusions extending from the implemented body that are configured to amplify forces experienced by the implemented body. In some embodiments, the protrusions can be deployable during advancement of the implemented body in the vasculature of a patient. For example, the logic of the console can be configured to receive user input initiating deployment, such that in response, the logic transmits a signal causing deployment (e.g., a flap can extend from the implemented body substantially perpendicular to the direction of the anticipated (or detected) force or motion). In such embodiments, such protrusions experience greater fluctuations with each passing volume of blood, vasospasm, etc. as compared to implemented bodies without protrusions.

[0024] Some embodiments of the disclosure relate to medical device systems for detecting fluctuations using fiber optic technology of a medical device. The system can include a medical device including an optical fiber having one or more core fibers, each of the one or more core fibers including a plurality of sensors distributed along a longitudinal length of the respective core fiber, and each of the plurality of sensors configured to: (i) reflect a different spectral width of light signals based on received incident light; and (ii) change a characteristic of the reflected light signals based on a strain experienced by the optical fiber. The system can further include a console including one or more processors and a non-transitory computer-readable medium having logic stored thereon that, when executed by the one or more processors, causes operations including: providing the optical fiber with a broadband incident light signal, receiving different spectral widths of reflected light signals reflected by one or more of the plurality of sensors from the broadband incident light, processing the reflected light signals associated with the one or more core fibers to detect fluctuations of a distal tip of the optical fiber, and determining a location of the distal tip of the optical fiber or a defect affecting a vessel in which the distal tip is disposed based on the detected fluctuations.

[0025] In some embodiments, the optical fiber is a single-core optical fiber. In alternative embodiments, the optical fiber is a multi-core optical fiber including a plurality of core fibers. In some embodiments, the defect is one of a vessel constriction, a vessel spasm, or a vessel occlusion.

[0026] In certain embodiments, the determining performed by the logic includes correlating the reflected light signals with previously obtained reflected light signals to identify the location of the distal tip of the optical fiber or the defect affecting the vessel, and determining whether a correlation result is above a first threshold. In some embodiments, the correlating is performed by a machine learning technique. In certain embodiments, the determining the location of the distal tip of the optical fiber includes obtaining an electrocardiogram (ECG) signal, correlating the ECG signal with the detected fluctuations to identify whether the detected fluctuations include a motion according to a rhythm pattern of the ECG signal, and determining whether a correlation result is above a first threshold.

[0027] In some embodiments, the medical device is one of a guidewire, a wire, a stylet, a stylet within a needle, a needle with a sheath of an optical fiber embedded in the needle, or a catheter with an optical fiber embedded in one or more walls of the catheter. Additionally, in some embodiments, each of the plurality of sensors is a reflective grating, where each reflective grating changes its reflected light signal by applying a wavelength shift that depends on a strain experienced by the reflective grating. Some embodiments can include the logic that, when executed by the one or more processors, causes further operations including generating a warning indicating a presence of the defect. In certain embodiments, the warning includes an indication of a location of the defect.

[0028] Some embodiments of the disclosure relate to a method for placing a medical device into a patient, the method comprising providing a broadband incident light signal to an optical fiber included in the medical device, wherein the optical fiber comprises one or more core fibers, each of the one or more core fibers comprising a plurality of reflective gratings distributed along a longitudinal length of the respective core fiber, and each of the plurality of reflective gratings is configured to: (i) reflect a different spectral width of light signals based on the received incident light, and (ii) change a characteristic of the reflected light signals based on a strain experienced by the optical fiber. The method comprises receiving the different spectral width of reflected light signals of the broadband incident light reflected by one or more of the plurality of sensors, processing the reflected light signals associated with the one or more core fibers to detect a fluctuation of a distal tip of the optical fiber, and determining a location of the distal tip of the optical fiber or a defect affecting a vessel in which the distal tip is disposed based on the detected fluctuation.

[0029] In some embodiments, the optical fiber is a single-core optical fiber. In alternative embodiments, the optical fiber is a multi-core optical fiber comprising a plurality of core fibers. In some embodiments, the defect is one of a vessel constriction, a vessel spasm, or a vessel occlusion.

[0030] In certain embodiments, the determining performed by the logic comprises correlating the reflected light signals with previously obtained reflected light signals to identify the location of the distal tip of the optical fiber or the defect affecting the vessel, and determining whether a correlation result is above a first threshold. In some embodiments, the correlating is performed by a machine learning technique. In certain embodiments, the determining the location of the distal tip of the optical fiber comprises obtaining an electrocardiogram (ECG) signal, correlating the ECG signal with the detected fluctuation to identify whether the detected fluctuation comprises a motion according to a rhythm pattern of the ECG signal, and determining whether a correlation result is above a first threshold.

[0031] In some embodiments, the medical device is one of a guidewire, a wire, a stylet, a stylet within a needle, a needle with a sheath of an optical fiber embedded in the needle, or a catheter with an optical fiber embedded in one or more walls of the catheter. Additionally, in some embodiments, each of the plurality of sensors is a reflective grating, wherein each reflective grating changes its reflected light signal by applying a wavelength shift that depends on a strain experienced by the reflective grating. Some embodiments can comprise logic that, when executed by the one or more processors, causes further operations comprising generating a warning indicating a presence of the defect. In certain embodiments, the warning comprises an indication of a location of the defect.

[0032] Other embodiments of the disclosure relate to a non-transitory computer- readable medium having logic stored thereon that, when executed by one or more processors, causes operations including providing a broadband incident light signal to an optical fiber included within a medical device, wherein the optical fiber includes one or more core fibers, each of the one or more core fibers includes a plurality of reflective gratings distributed along a respective core fiber longitudinal length, and each of the plurality of reflective gratings is configured to (i) reflect a different spectral width of light signals based on received incident light, and (ii) change a characteristic of the reflected light signals based on a strain experienced by the optical fiber; receiving the different spectral width of reflected light signals of the broadband incident light reflected by one or more of a plurality of sensors; processing the reflected light signals associated with the one or more core fibers to detect a fluctuation of a distal tip of the optical fiber; and determining a location of the distal tip of the optical fiber or a defect affecting a vessel in which the distal tip is disposed based on the detected fluctuation.

[0033] In some embodiments, the optical fiber is a single-core optical fiber. In alternative embodiments, the optical fiber is a multi-core optical fiber including a plurality of core fibers. In some embodiments, the defect is one of a vessel constriction, a vessel spasm, or a vessel occlusion.

[0034] In certain embodiments, the determining performed by the logic includes correlating the reflected light signals with previously obtained reflected light signals to identify the location of the distal tip of the optical fiber or the defect affecting the vessel, and determining whether a correlation result is above a first threshold. In some embodiments, the correlating is performed by a machine learning technique. In certain embodiments, the determining the location of the distal tip of the optical fiber includes obtaining an electrocardiogram (ECG) signal, correlating the ECG signal with the detected fluctuation to identify whether the detected fluctuation includes a motion according to a rhythm pattern of the ECG signal, and determining whether a correlation result is above a first threshold.

[0035] In some embodiments, the medical device is one of a guidewire, a wire, a stylet, a stylet within a needle, a needle with a sheath having an optical fiber embedded therein, or a catheter with one or more walls of the catheter having an optical fiber embedded therein. Additionally, in some embodiments, each of the plurality of sensors is a reflective grating, wherein each reflective grating changes its reflected light signal by applying a wavelength shift that depends on a strain experienced by the reflective grating. Some embodiments can include the logic that, when executed by the one or more processors, causes further operations including generating a warning indicating a presence of the defect. In certain embodiments, the warning includes an indication of a location of the defect.

[0036] These and other features of the concepts provided herein will become more apparent from the following detailed description in conjunction with the accompanying drawings, which are provided to assist in understanding the concepts of the present disclosure and are not intended to limit the concepts in any way. BRIEF DESCRIPTION OF DRAWINGS

[0037] Embodiments of the disclosure are illustrated by way of example in the accompanying drawings, in which like reference numerals indicate similar elements, and in which:

[0038] Figure 1A is an illustrative embodiment of a medical instrument monitoring system according to some embodiments, the medical instrument monitoring system including a medical instrument having optical shape sensing and fiber-based oximetry capabilities;

[0039] Figure 1B is an alternative illustrative embodiment of a medical instrument monitoring system 100 according to some embodiments;

[0040] Figure 2 is an exemplary embodiment of a structure of a portion of a multi-core fiber included within a stylet 120 of Figure 1A

[0041] Figure 3A is an alternative illustrative embodiment of a medical instrument monitoring system according to some embodiments, the medical instrument monitoring system including a medical instrument having optical shape sensing and fiber-based oximetry capabilities; Figure 1A

[0042] Figure 3B is a cross-sectional view of a stylet of Figure 3A

[0043] Figure 4A is an alternative illustrative embodiment of a medical instrument monitoring system according to some embodiments, the medical instrument monitoring system including a medical instrument having optical shape sensing and fiber-based oximetry capabilities; Figure 1B

[0044] Figure 4B is a cross-sectional view of a stylet of Figure 4A

[0045] Figure 5A is a front view of a first illustrative embodiment of a catheter including integrated tubing, a septum arranged diametrically, and a micro-lumen within the tubing and the septum according to some embodiments;

[0046] Figure 5B is a perspective view of a first illustrative embodiment of a catheter including a core fiber mounted within a micro-lumen of Figure 5A

[0047] Figures 6A-6B is a flowchart of a method of operation to enable optical 3D shape sensing implemented by a medical instrument monitoring system of Figures 1A-1B

[0048] ​​​​​​​Figure 7 is a medical instrument monitoring system according to some embodiments Figure 1A is an exemplary embodiment of a medical instrument monitoring system during catheter operation and insertion into a patient according to some embodiments;

[0049] Figure 8A is a detailed view of a stylet advanced in a superior vena cava (SVC) toward a right atrium of a patient according to some embodiments;

[0050] Figure 8B is a side view of a stylet advanced through a vessel of a patient’s vasculature toward a constriction in the vessel according to some embodiments;

[0051] Figure 8C is a side view of a stylet advanced through a vessel of a patient’s vasculature toward vasospasm affecting the vessel according to some embodiments; and

[0052] Figure 8D is a side view of a stylet advanced through a vessel of a patient’s vasculature toward an occlusion in the vessel according to some embodiments. DETAILED DESCRIPTION

[0053] Before some embodiments are disclosed in more detail, the specific embodiments disclosed herein are not intended to limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be readily separated from the specific embodiments into individual features or alternative embodiments that can be combined with or substituted for features of the many other embodiments disclosed herein.

[0054] With respect to the terms used herein, it should also be understood that these terms are used to describe some specific embodiments for the purpose of descriptive convenience and are not intended to 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 supply a serial or numerical limitation. For example, a “first,” “second,” “third” feature or step need not necessarily appear in that order and the particular embodiments including these features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation or direction. Rather, such labels are used in connection with the orientation as the object is typically presented to an observer. Unless the context clearly indicates otherwise, singular forms of words such as “a,” “an” and “the” include plural referents.

[0055] “proximal,”“proximal portion,” or“proximal end portion” of a probe, e.g., disclosed herein, includes a portion of the probe that is intended to be proximal to a clinician when the probe is used on a patient. Likewise,“proximal length” of a probe, e.g., includes a length of the probe that is intended to be proximal to a clinician when the probe is used on a patient. For example,“proximal end” of a probe includes an end of the probe that is intended to be proximal to a clinician when the probe is used on a patient. A proximal portion, proximal end portion, or proximal length of a probe can include a proximal end of the probe; however, a proximal portion, proximal end portion, or proximal length of a probe does not necessarily include a proximal end of the probe. That is, unless context dictates otherwise, a proximal portion, proximal end portion, or proximal length of a probe is not a terminal portion or terminal length of the probe.

[0056] “distal,”“distal portion,” or“distal end portion” of a probe, e.g., disclosed herein, includes a portion of the probe that is intended to be proximal to a patient or in a patient when the probe is used on a patient. Likewise,“distal length” of a probe, e.g., includes a length of the probe that is intended to be proximal to a patient or in a patient when the probe is used on a patient. For example,“distal end” of a probe includes an end of the probe that is intended to be proximal to a patient or in a patient when the probe is used on a patient. A distal portion, distal end portion, or distal length of a probe can include a distal end of the probe; however, a distal portion, distal end portion, or distal length of a probe does not necessarily include a distal end of the probe. That is, unless context dictates otherwise, a distal portion, distal end portion, or distal length of a probe is not a terminal portion or terminal length of the probe.

[0057] The term“logic” can refer to hardware, firmware, or software configured to perform one or more functions. As hardware, the term logic can refer to or include circuitry having data processing and / or storage functionality. Examples of such circuitry can include, but are not limited 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.), semiconductor memory, or a combination element.

[0058] Additionally or in the alternative, the term logic can refer to or include software, such as one or more processes, one or more instances, application programming interfaces (APIs), subroutines, functions, applets, servlets, routines, source code, object code, shared libraries / dynamic link libraries (dlls), 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., electrical, optical, acoustical or other form of propagated signals, such as carrier waves, infrared signals or digital signals), either on a

[0059] Reference is made to Figure 1A An illustrative embodiment of a medical instrument monitoring system including a medical instrument having optical shape sensing and fiber-based oximetry capability is shown in accordance with some embodiments. As shown, the system 100 generally includes a console 110 and a stylet assembly 119 communicatively coupled to the console 110. For this embodiment, the stylet assembly 119 includes an elongate probe (e.g., stylet) 120 on a distal end 122 thereof and a console connector 133 on a proximal end 124 thereof, with the stylet 120 configured to be advanced within a patient vasculature by or with a catheter 195. The console connector 133 enables the stylet assembly 119 to be operably connected to the console 110 via an interconnect 145 including one or more optical fibers 147 (hereinafter referred to as "fiber(s)") and a conductive medium terminated by a single optical / electrical connector 146 (or terminated by a dual connector). Here, the connector 146 is configured to engage (matingly couple) with the console connector 133 to allow optical propagation between the console 110 and the stylet assembly 119 and electrical signal propagation from the stylet 120 to the console 110.

[0060] An exemplary implementation of the console 110 includes a processor 160, a memory 165, a display 170, and optical logic 180, although it is understood that the console 110 can take one of a variety of forms and can include additional components not pertinent to aspects of the disclosure (e.g., power supply, ports, interfaces, etc.). An illustrative example of the console 110 is shown in U.S. Pub. No. 2019 / 0237902, which is incorporated by reference herein in its entirety. The processor 160 is included to control the functions of the console 110 during operation, and is able to access the memory 165 (e.g., non-volatile memory or non-transitory computer readable medium). As shown, the display 170 can be a liquid crystal diode (LCD) display integrated into the console 110 and is used as a user interface to display information to a clinician, particularly during a catheter placement procedure (e.g., cardiac catheterization). In another embodiment, the display 170 can be separate from the console 110. Although not shown, a user interface is configured to provide user control of the console 110.

[0061] For both embodiments, the content depicted by the display 170 can change depending on the mode (optical, TLS, ECG, or another modality) that the stylet 120 is configured to operate in. In the TLS mode, the content presented by the display 170 can constitute a two-dimensional (2D) or three-dimensional (3D) representation of the physical state (e.g., length, shape, form, and / or orientation) of the stylet 120, which is computed from the characteristics of the reflected light signal 150 returned to the console 110. The reflected light signal 150 constitutes light of a particular spectral width of the broadband incident light 155 that is reflected back to the console 110. According to one embodiment of the disclosure, the reflected light signal 150 can involve various discrete portions (e.g., particular spectral widths) of the broadband incident light 155 delivered from and originating at the optical logic 180, as described below.

[0062] According to one embodiment of the disclosure, the activation control 126 included on the stylet assembly 119 can be used to set the stylet 120 to a desired mode of operation, and to selectively change the operability of the display 170 by the clinician to aid in medical device placement. For example, based on the modality of the stylet 120, the display 170 of the console 110 can be used to conduct optical modality-based guidance during catheter advancement through the vasculature or during the TLS modality to determine the physical state (e.g., length, form, shape, orientation, etc.) of the stylet 120. In one embodiment, information from multiple modes, such as optical, TLS, or ECG, for example, can be displayed simultaneously (e.g., at least partially overlapping in time).

[0063] Still referring to Figure 1A, the optical logic 180 is configured to support operability of the stylet assembly 119 and enable return of information to the console 110, which can be used to determine physical states associated with the stylet 120 and monitored electrical signals, such as ECG signaling via electrical signaling logic 181 that supports receiving and processing received electrical signals from the stylet 120 (e.g., ports, analog-to-digital conversion logic, etc.). The physical states of the stylet 120 can be based on changes in characteristics of the reflected light signal 150 received at the console 110 from the stylet 120. Characteristics can include wavelength shifts caused by strain on certain regions of the core fiber integrated within the fiber core located within or as the stylet 120 operates, as follows. As discussed herein, the fiber core can include core fibers 1371-137 M (for a single core, M = 1, for multiple cores, M > 2), where the core fibers 1371-137 M may be collectively referred to as core fiber(s) 137. Unless otherwise indicated or a different interpretation is required by the present embodiment, embodiments discussed herein will refer to a multi-core fiber 135. From the information associated with the reflected light signal 150, the console 110 can determine (by calculation or extrapolation of wavelength shifts) the physical state of the stylet 120, and the physical state of the catheter 195 configured to receive the stylet 120.

[0064] According to one embodiment of the disclosure, as Figure 1A shown, the optical logic 180 can include a light source 182 and an optical receiver 184. The light source 182 is configured to deliver incident light 155 (e.g., broadband) for propagation over the fiber(s) 147 included in the interconnect 145, which are optically connected to the multi-core fiber 135 within the stylet 120. In one embodiment, the light source 182 is a tunable swept laser, although other suitable light sources besides lasers can also be employed, including semi-coherent light sources, LED light sources, etc.

[0065] The optical receiver 184 is configured to: (i) receive the returned optical signals, i.e., reflected optical signals 150 received from the fiber-optic based reflective gratings (sensors) fabricated within each core fiber of the multicore optical fiber 135 deployed within the stylet 120; and (ii) convert the reflected optical signals 150 into reflected data (from the repository 192), i.e., data in the form of electrical signals representative of the reflected optical signals, including wavelength shifts caused by strain, that include the reflected optical signals 151 provided from the sensors located in the central core fiber (reference) of the multicore optical fiber 135 and the reflected optical signals 152 provided from the sensors located in the peripheral core fibers of the multicore optical fiber 135, as described below. Here, the optical receiver 184 can be implemented as a photodetector, such as a positive-intrinsic-negative “PIN” photodiode, an avalanche photodiode, etc.

[0066] As shown, both the optical source 182 and the optical receiver 184 are operably connected to the processor 160 that manages their operation. Further, the optical receiver 184 is operably coupled to provide the reflected data (from the repository 192) to the memory 165 for storage and processing by the reflected data classification logic 190. The reflected data classification logic 190 can be configured to: (i) identify which core fibers are associated with which of the received reflected data (from the repository 192); and (ii) segment the reflected data stored in the repository 192 (provided by the reflected optical signals 150 associated with similar regions or spectral widths of the stylet 120) into analysis groups. The reflected data of each analysis group is available to the shape sensing logic 194 for analysis.

[0067] According to one embodiment of the disclosure, the shape sensing logic 194 is configured to compare the wavelength shifts measured by the sensors in each of the peripheral core fibers deployed at the same measurement region (or the same spectral width) of the stylet 120 with the wavelength shifts at the central core fiber of the multicore optical fiber 135 positioned along the central axis and operating as a bend neutral axis. From these analyses, the shape sensing logic 194 can determine the shape assumed by the core fibers in the 3D space and can further determine the current physical state of the catheter 195 in the 3D space for presentation on the display 170.

[0068] According to one embodiment of the disclosure, the shape sensing logic 194 can generate a rendering of the current physical state of the stylet 120 (and potentially the catheter 195) based on heuristics or run-time analysis. For example, the shape sensing logic 194 can be configured according to machine learning techniques to access a data store (library) having pre-stored data (e.g., images, etc.) relating to different regions of the stylet 120 (or catheter 195) in which reflected light from the different core fibers has previously experienced similar or identical wavelength shifts. From the pre-stored data, a rendering of the current physical state of the stylet 120 (or catheter 195) can be presented. Alternatively as another embodiment, the shape sensing logic 194 can be configured to determine changes in the physical state of each region of the multi-core optical fiber 135 during run-time based at least on: (i) the resultant wavelength shifts experienced by the different core fibers within the optical fiber 135; and (ii) the relationship between these wavelength shifts generated by the sensors positioned along the different peripheral core fibers at the same cross-sectional region of the multi-core optical fiber 135 and the wavelength shifts generated by the sensors of the central core fiber at the same cross-sectional region. It is contemplated that other processes and procedures can be performed to render the appropriate changes in the physical state of the stylet 120 (and / or catheter 195) utilizing the wavelength shifts measured by the sensors along each core fiber within the multi-core optical fiber 135, particularly when the stylet 120 is positioned at the distal tip of the catheter 195, enabling guidance of the stylet 120 within the vasculature of the patient and at the desired destination within the body.

[0069] The console 110 can further include electrical signaling logic 181 positioned to receive one or more electrical signals from the stylet 120. The stylet 120 is configured to support both optical connectivity and electrical connectivity. The electrical signaling logic 181 receives electrical signals (e.g., ECG signals) from the stylet 120 via a conductive medium. The electrical signals can be processed by the electrical signal logic 196, executed by the processor 160, to determine ECG waveforms for display.

[0070] Additionally, the console 110 includes fluctuation logic 198 configured to analyze at least a subset of the wavelength shifts measured by the sensors deployed in each core fiber 137. In particular, the fluctuation logic 198 is configured to analyze the wavelength shifts measured by the sensors of the core fibers 137, where this corresponds to an analysis of fluctuations of the distal tip of the stylet 120 (or "tip fluctuation analysis"). In some embodiments, the fluctuation logic 198 analyzes the wavelength shifts measured by the sensors at the distal ends of the core fibers 137. The tip fluctuation analysis includes at least a correlation of the detected motion of the distal tip of the stylet 120 (or other medical device or instrument) with empirical knowledge, which includes previously detected motions (fluctuations) and optionally other current measurements such as ECG signals. The empirical knowledge can include previously detected motions in various locations within the vasculature (e.g., SVC, inferior vena cava (IVC), right atrium, azygos vein, other vessels such as arteries and veins) under normal, healthy conditions and under the presence of defects (e.g., vessel constriction, vessel spasm, vessel occlusion, etc.). Thus, the tip fluctuation analysis can result in confirming the tip location and / or detecting defects affecting the blood vessel.

[0071] It should be noted that the fluctuation logic 198 need not perform the same analysis as the shape sensing logic 194. For example, the shape sensing logic 194 determines the 3D shape of the stylet 120 by comparing the wavelength shifts in the outer core fibers of the multicore optical fiber to the central reference core fiber. The fluctuation logic 198 can instead correlate the wavelength shifts to previously measured wavelength shifts and optionally other current measurements without distinguishing between the wavelength shifts of the outer core fibers and the central reference core fiber, as the tip fluctuation analysis need not account for direction or shape within the 3D space.

[0072] In some embodiments, e.g., those directed to tip location confirmation, the analysis of the fluctuation logic 198 can utilize electrical signals (e.g., ECG signals) measured by the electrical signaling logic 181. For example, the fluctuation logic 198 can compare the motion of a sub-portion of the stylet 120 (e.g., the distal tip) to the electrical signals representing the pulses of the heart (e.g., heartbeats). This comparison can reveal whether the distal tip is within the SVC or the right atrium based on how closely the motion corresponds to the rhythmic heartbeats.

[0073] In various embodiments, displays and / or alerts can be generated based on the wave analysis. For example, the wave logic 198 can generate a graph illustrating the detected wave as compared to previously detected tip waves and / or anatomical motion within the patient, such as the rhythmic beating of the heart and / or expansion and contraction of the lungs. In one embodiment, such a graph can include a dynamic visualization of the movement of the medical device according to the detected wave adjacent to the secondary medical device according to the previously detected tip wave movement. In some embodiments, the positions of the sub-portion of the medical device can be obtained from the shape sensing logic 194 and the dynamic visualization can be position specific (e.g., such that the previously detected wave illustrates the expected wave of the current position of the sub-portion). In alternative embodiments, the dynamic visualization can illustrate a comparison of the dynamic movement of the sub-portion to the dynamic movement of one or more sub-portions according to previously detected waves affecting one or more defects of the vessel and as a result the position of the catheter 195.

[0074] According to one embodiment of the disclosure, the wave logic 198 can determine whether the movement of one or more sub-portions of the stylet 120 is indicative of the position of a particular sub-portion of the stylet 120 or a defect affecting the vessel and as a result the position of the catheter 195 based on heuristics or run-time analysis. For example, the wave logic 198 can be configured according to machine learning techniques to access a data store having pre-stored data (e.g., empirical knowledge of previously detected tip wave data, etc.) related to different regions (sub-portions) of the stylet 120. In particular, such an embodiment can include processing of a machine learning model trained using the empirical knowledge, where the detected wave is used as an input to the trained model and the processing of the trained model results in a determination of the proximity of the detected wave to one or more locations within the vasculature of the patient and / or one or more defects affecting the vessel.

[0075] In some embodiments, the wave logic 198 can be configured to determine whether the movement of one or more sub-portions of the stylet 120 (and the catheter 195) is indicative of the position of a particular sub-portion of the stylet 120 or a defect affecting the vessel based on at least the following during run-time: (i) the resultant wavelength shift experienced by the core fiber 137 within the one or more sub-portions; and (ii) the correlation of these wavelength shifts produced by the sensors positioned along different core fibers at the same cross-sectional region of the stylet 120 (or the catheter 195) to previously detected wavelength shifts produced by corresponding sensors in the core fiber at the same cross-sectional region. It is contemplated that other processes and procedures can be performed to utilize the wavelength shifts measured by the sensors along each core fiber 137 to provide appropriate movement in the distal tip of the stylet 120 and / or the catheter 195.

[0076] Referring toFigure 1B An alternative exemplary embodiment of a medical instrument monitoring system 100 is shown. Here, the medical instrument monitoring system 100 features a console 110 and a medical instrument 130 communicatively coupled to the console 110. For this embodiment, the medical instrument 130 corresponds to a catheter featuring an integrated tubing having two or more lumens extending between a proximal end 131 and a distal end 132 of the integrated tubing. The integrated tubing (sometimes referred to as "catheter tubing") is in communication with one or more extension legs 140 via a bifurcated hub 142. An optical-based catheter connector 144 can be included on a proximal end of at least one extension leg 140 to enable the catheter 130 to be operatively connected to the console 110 via an interconnect 145 or another suitable component. Here, the interconnect 145 can include a connector 146 that, when coupled to the optical-based catheter connector 144, establishes optical connectivity between one or more optical fibers 147 (hereinafter, "optical fiber(s)") included as part of the interconnect 145 and a core fiber 137 disposed within the catheter 130 and integrated into the tubing. Alternatively, different combinations of connectors including one or more adapters can be used to optically connect the optical fiber(s) 147 to the core fiber 137 within the catheter 130. As Figure 1B shown, the core fiber 137 disposed within the catheter 130 includes the same characteristics and performs the same functions as the core fiber 137 disposed within the Figure 1A stylet 120.

[0077] The optical logic 180 is configured to support graphical rendering of the catheter 130 (most notably, the integrated tubing of the catheter 130) based on characteristics of the reflected light signal 150 received from the catheter 130. The characteristics can include wavelength shifts caused by strain on certain regions of the core fiber 137 integrated within (or along) the wall of the integrated tubing, which can be used (through calculation or extrapolation of the wavelength shifts) to determine the physical state of the catheter 130, particularly the integrated tubing or a portion of the integrated tubing (such as a tip or distal end of the tubing) to read the tip's (or distal end's) fluctuations (real-time movements).

[0078] More specifically, the optical logic 180 includes a light source 182. The light source 182 is configured to transmit a broadband incident light 155 so as to propagate over the optical fiber(s) 147 included in the interconnect 145, which are optically connected to the plurality of core fibers 137 within the catheter tubing. Here, an optical receiver 184 is configured to: (i) receive a return light signal, i.e., a reflected light signal 150 received from a fiber-optic based reflective grating (sensor) fabricated within each of the core fibers 137 deployed within the catheter 130; and (ii) convert the reflected light signal 150 into reflected data (from a repository 192), i.e., data in the form of electrical signals representative of the reflected light signal, which includes a wavelength shift caused by the strain. The reflected light signals 150 associated with different spectral widths include a reflected light signal 151 provided from a sensor located in a central core fiber (reference) of the catheter 130 and a reflected light signal 152 provided from a sensor located in an outer core fiber of the catheter 130, as described below.

[0079] As noted above, the shape sensing logic 194 is configured to compare the wavelength shifts measured by the sensors deployed in each of the outer core fibers at the same measurement region (or same spectral width) of the catheter with the wavelength shift at the central core fiber, which is positioned along the central axis and operates as a bend neutral axis. From these analyses, the shape sensing logic 190 can determine the shape assumed by the core fibers in the 3D space and can further determine the current physical state of the catheter 130 in the 3D space so as to be presented on the display 170.

[0080] According to one embodiment of the disclosure, the shape sensing logic 194 can generate a presentation of the current physical state of the catheter 130 (particularly the integrated tubing) based on heuristics or run-time analysis. For example, the shape sensing logic 194 can be configured according to machine learning techniques to access a data store (repository) having pre-stored data (e.g., images, etc.) related to different regions of the catheter 130 in which the core fibers 137 experience similar or identical wavelength shifts. From the pre-stored data, the current physical state of the catheter 130 can be presented. Alternatively, as another embodiment, the shape sensing logic 194 can be configured to determine changes in the physical state of each region of the catheter 130 during run-time based on at least: (i) the composite wavelength shift experienced by the core fibers 137; and (ii) the relationship between these wavelength shifts produced by the sensors positioned along the different outer core fibers at the same cross-sectional region of the catheter 130 and the wavelength shift produced by the sensor of the central core fiber at the same cross-sectional region. It is contemplated that other processes and procedures can be performed to utilize the wavelength shifts measured by the sensors along each of the core fibers 137 to present appropriate changes in the physical state of the catheter 130.

[0081] refer to Figure 2 According to some implementation schemes, it is shown that includes Figure 1A An exemplary embodiment of the structure of a portion of the multi-core optical fiber within the core pin 120. The multi-core optical fiber portion 200 of the multi-core optical fiber 135 shows certain core fibers 1371-137. M (M≥2, such as) Figure 3A As shown, M=4), and respectively present in core fibers 1371-137 M Internal sensors (e.g., reflective gratings) 210 11 -210 NM The spatial relationship between (N≥2; M≥2). As described above, the core fibers 1371-137 M Collectively referred to as "core fiber 137".

[0082] As shown in the figure, part 200 is divided into multiple cross-sectional regions 2201-220. N Each cross-sectional region is 2201-220. N Corresponding to reflection grating 210 11 -210 14 …210 N1 -210 N4 Cross-sectional region 2201…220 N Some or all of them can be static (e.g., a specified length) or dynamic (e.g., in regions 2201…220). N (with variations in size). The first core fiber 1371 is positioned substantially along the central (neutral) axis 230, while the core fiber 1372 may be oriented within the cladding of the multi-core fiber 135, located on top of the first core fiber 1371 from a forward-facing view of the cross section. In this deployment, cores 1373 and 1374 may be located on the lower left and lower right sides of the first core fiber 1371, respectively. As an example, Figures 3A-4B Such an explanation was provided.

[0083] Referring to the first core fiber 1371 as an example in the specification, when the core needle 120 is operational, the reflective gratings 2101-210... N Each of the reflectors contains light with a different spectral width. As shown in the figure, according to one embodiment of the published text, grating 210 1i -210 Ni Each of (1≤i≤M) is associated with a different specific spectral width, which will be determined by different center frequencies f1…f N This indicates that the adjacent spectral widths reflected by adjacent gratings do not overlap.

[0084] Here, located in different core fibers 1372-1373, but along the same cross-sectional region 220-220 of the multi-core fiber 135. N grating 210 12 -210 N2 and 210 13 -210 N3 The incident light is configured to be reflected at the same (or substantially similar) center frequency. As a result, the returned reflected light allows information to be determined about the physical state of the fiber 137 (and the mandrel 120) based on the wavelength shift measured from the returned reflected light. Specifically, strain (e.g., compression or tension) applied to the multi-core fiber 135 (e.g., at least core fibers 1372-1373) results in a wavelength shift associated with the returned reflected light. Depending on their location, the core fibers 1371-1374 experience different types and degrees of strain (based on changes in the angular path as the mandrel 120 advances within the patient).

[0085] For example, relative to Figure 2 The multi-core fiber portion 200, in response to the angular movement (e.g., radial movement) of the core needle 120, is in a left-turning direction, and the fourth core fiber 1374 of the multi-core fiber 135, having the shortest radius during movement (see...). Figure 3A (For example, the core fiber closest to the direction of angular change) will exhibit compression (e.g., a force that shortens its length). Simultaneously, the third core fiber 1373, which has the longest radius during movement (e.g., the core fiber furthest from the direction of angular change), will exhibit stretching (e.g., a force that increases its length). Because these forces are different and unequal, the reflective grating 210 associated with core fibers 1372 and 1373... N2 and 210 N3 The reflected light will exhibit different wavelength variations. By determining the wavelength relative to a reference core fiber (e.g., the first core fiber 1371) located along the neutral axis 230 of the multi-core fiber 135, the degree of wavelength variation caused by compression / stretching in each peripheral fiber (e.g., the second core fiber 1372 and the third core fiber 1373) can be used to determine the physical configuration of the extrapolation core 120. These degrees of wavelength variation can be used to determine the physical state of the extrapolation core 120. The reflected light signal 150 passes through specific core fibers 1371-1372. M The separate path above is reflected back to console 110.

[0086] See Figure 3A According to some implementation schemes, Figure 1A A first exemplary embodiment of the core needle supports both optical and telecommunication communication. Here, the core needle 120 is characterized by a centrally located multi-core optical fiber 135, which includes a cladding 300 and corresponding plurality of inner cavities 3201-320.M Multiple core fibers 1371-137 M (M≥2; M=4). Although the multi-core fiber 135 is illustrated within four (4) core fibers 1371-1374, a greater number of core fibers 1371-137 can be deployed. M (M>4) to provide more detailed three-dimensional sensing of the physical state (e.g., shape, etc.) of the multi-core fiber 135 and the core needle 120 of the deployed fiber 135.

[0087] In this embodiment of the disclosed text, the multi-core optical fiber 135 is encapsulated within a concentric braided tube 310 located above a low-friction coefficient layer 335. The braided tube 310 may be characterized by a "mesh" construction, wherein the spacing between the intersecting conductive elements is selected based on the required rigidity of the core 120, as a larger spacing can provide less rigidity and thus provide a more flexible core 120.

[0088] According to the implementation scheme in the publicly available text, such as Figures 3A-3B As shown, core fibers 1371-1374 include (i) a central core fiber 1371 and (ii) a plurality of peripheral core fibers 1372-1374, which are held within cavities 3201-3204 formed in the cladding 300. According to one embodiment of the disclosed text, the diameter of one or more of the cavities 3201-3204 may be configured to be larger than the diameter of the core fibers 1371-1374. By avoiding direct physical contact between a large portion of the surface area of ​​the core fibers 1371-1374 and the wall surfaces of the cavities 3201-3204, the wavelength variation of the incident light caused by angular deviations in the multi-core fiber 135 is reduced, thereby minimizing the wavelength variation applied to the cavities 3201-3204. M The wall (not the core fiber 1371-137) M The influence of pressure and tension (on itself).

[0089] like Figures 3A-3B As further shown, core fibers 1371-1374 may include a central core fiber 1371 located within a first cavity 3201 formed along the first neutral axis 230 and multiple core fibers 1372-1374 located within cavities 3202-3204 (each formed in a different region of the cladding 300 radiating from the first neutral axis 230). Typically, core fibers 1372-1374 (excluding the central core fiber 1371) may be located in different regions within the cross-sectional region 305 of the cladding 300 to provide sufficient spacing to enable three-dimensional sensing of the multi-core fiber 135 based on wavelength changes of incident light propagating through the core fibers 1372-1374 and reflected back to the console for analysis.

[0090] For example, the cladding 300 is characterized by, for example,Figure 3B In the case of the circular cross-sectional region 305 shown, the core fibers 1372-1374 can be positioned substantially equidistant from each other along the perimeter of the cladding 300, for example, at the positions shown as "top" (12 o'clock), "lower left" (8 o'clock), and "lower right" (4 o'clock). Therefore, in general, the core fibers 1372-1374 can be located within different segments of the cross-sectional region 305. In the case where the cross-sectional region 305 of the cladding 300 has a distal tip 330 and is characterized by a polygonal cross-sectional shape (e.g., triangle, square, rectangle, pentagon, hexagon, octagon, etc.), the central fiber 1371 can be located at or near the center of the polygonal shape, while the remaining core fibers 1372-1374... M It can be located near the corner between the intersecting sides of a polygonal shape.

[0091] Still referencing Figures 3A-3B As the conductive medium for the core 120, the braided tubing 310 provides mechanical integrity to the multi-core optical fiber 135 and operates as a conductive path for electrical signals. For example, the braided tubing 310 may be exposed at the distal tip of the core 120. The cladding 300 and the braided tubing 310 (which are concentrically positioned around the circumference of the cladding 300) are housed within the same insulating layer 350. As shown, the insulating layer 350 may be a sheath or conduit made of a protective insulating (e.g., non-conductive) material that encloses both the cladding 300 and the braided tubing 310.

[0092] See Figure 4A According to some implementation schemes, Figure 1A A second exemplary embodiment of the core needle. Now refer to... Figure 4A , showed Figure 1A A second exemplary embodiment of the core 120 supports both optical signaling and telecommunication signaling. Here, the core 120 is characterized as described above and Figure 3A The multi-core optical fiber 135 shown includes a cladding 300 and multiple corresponding cavities 3201-320. M The first multiple core fibers 1371-137 M (M≥3; for the implementation, M=4). For the implementation described in the disclosed text, the multi-core optical fiber 135 includes a central core fiber 1371 located within a first cavity 3201 formed along a first neutral axis 230 and a plurality of second core fibers 1372-1374 located within corresponding cavities 3202-3204 in different segments positioned within a cross-sectional region 305 of the cladding 300. Here, the multi-core optical fiber 135 is encapsulated within a conductive tube 400. The conductive tube 400 may be characterized as a “hollow” conductive cylindrical member concentrically encapsulating the multi-core optical fiber 135.

[0093] refer toFigures 4A-4B Operating as a conductive medium for the electrical signal (e.g., ECG signal) to the control console in transmission, the conductive tubing 400 can be exposed up to the tip 410 of the stylet 120. For this embodiment of the disclosure, a conductive epoxy 420 (e.g., metal-based epoxy such as silver epoxy) can be affixed to the tip 410 and similarly engaged with the termination / connection point created at the proximal end 430 of the stylet 120. The cladding 300 and the conductive tubing 400 (which is positioned concentrically around the circumference of the cladding 300) are housed within the same insulating layer 440. As shown, the insulating layer 440 can be a protective conduit that encapsulates both the cladding 300 and the conductive tubing 400.

[0094] Referring to Figure 5A A front view of a first illustrative embodiment of a catheter including an integrated tubing, a diaphragm arranged along a diameter, and micro-lumens formed within the tubing and the diaphragm is shown in accordance with some embodiments. Here, the catheter 130 includes an integrated tubing, a diaphragm 510 arranged along a diameter, and a plurality of micro-lumens 5301-5304, which for this embodiment are fabricated to lie within the wall 500 of the integrated tubing and within the diaphragm 510 of the catheter 130. In particular, the diaphragm 510 divides a single lumen formed by the inner surface 505 of the wall 500 of the catheter 130 into a plurality of lumens, i.e., two lumens 540 and 545 as shown. Here, a first lumen 540 is formed between a first arcuate portion 535 of the inner surface 505 forming the wall 500 of the catheter 130 and a first outer surface 555 of the diaphragm 510 extending longitudinally within the catheter 130. A second lumen 545 is formed between a second arcuate portion 565 of the inner surface 505 forming the wall 500 of the catheter 130 and a second outer surface 560 of the diaphragm 510.

[0095] In accordance with one embodiment of the present disclosure, the two lumens 540 and 545 have approximately the same volume. However, the diaphragm 510 need not divide the tubing into two equal lumens. For example, instead of the diaphragm 510 extending vertically (12 o'clock to 6 o'clock) from a forward-facing cross-sectional view of the tubing, the diaphragm 510 can extend horizontally (3 o'clock to 9 o'clock), diagonally (1 o'clock to 7 o'clock; 10 o'clock to 4 o'clock), or at an angle (2 o'clock to 10 o'clock). In the latter configuration, each of the lumens 540 and 545 of the catheter 130 will have a different volume.

[0096] Relative to the plurality of microcavities 5301-5304, the first microcavity 5301 is fabricated within the diaphragm 510 at or near the cross-sectional center 525 of the integrated tubing. For this embodiment, three microcavities 5302-5304 are fabricated within the wall 500 of the conduit 130. Specifically, the second microcavity 5302 is fabricated within the wall 500 of the conduit 130, specifically between the inner surface 505 and the outer surface 507 of the first arcuate portion 535 of the wall 500. Similarly, the third microcavity 5303 is also fabricated within the wall 500 of the conduit 130, specifically between the inner surface 505 and the outer surface 507 of the second arcuate portion 565 of the wall 500. The fourth microcavity 5304 is also fabricated within the inner surface 505 and the outer surface 507 of the wall 500 aligned with the diaphragm 510.

[0097] According to one implementation scheme in the publicly available text, such as Figure 5A As shown, microcavities 5302-5304 are positioned according to a “top left” (10 o’clock), “top right” (2 o’clock), and “bottom” (6 o’clock) layout from a forward-facing cross-sectional view. Of course, microcavities 5302-5304 can be positioned differently, as long as they are spatially separated along the circumference 520 of the conduit 130 to ensure more robust collection of reflected light signals from the outer core fibers 5702-5704 during installation. For example, two or more microcavities (e.g., microcavities 5302 and 5304) can be positioned in different quadrants along the circumference 520 of the conduit wall 500.

[0098] See Figure 5B According to some implementation schemes, Figure 5A A perspective view of a first illustrative embodiment of a catheter comprising a core fiber mounted within a microlumen. According to one embodiment of the disclosed text, the size of a second plurality of microlumens 5302-5304 is determined to hold the corresponding outer core fiber 5702-5704, wherein the diameter of each of the second plurality of microlumens 5302-5304 can be determined to be just larger than the diameter of the outer core fiber 5702-5704. For example, the dimensional difference between the diameter of a single core fiber and the diameter of any one of the microlumens 5301-5304 can range from 0.001 micrometers (μm) to 1000 μm. As a result, the cross-sectional area of ​​the outer core fiber 5702-5704 will be smaller than the cross-sectional area of ​​the corresponding microlumens 5302-5304. The “larger” microlumen (e.g., microlumen 5302) can better separate the external strain applied to the outer core fiber 5702 from the strain applied directly to the catheter 130 itself. Similarly, the size of the first microcavity 5301 can be set to hold the central core fiber 5701, wherein the diameter of the first microcavity 5301 can be set to be just larger than the diameter of the central core fiber 5701.

[0099] As an alternative embodiment of the disclosed text, the diameter of one or more of the microcavities 5301-5304 is determined to have a diameter exceeding that of the corresponding one or more core fibers 5701-5704. However, the size of at least one of the microcavities 5301-5304 is determined to permanently hold its corresponding core fiber (e.g., the core fiber is held such that there is no gap between its side surface and the inner wall surface of its corresponding microcavity). As yet another alternative embodiment of the disclosed text, the size of all the microcavities 5301-5304 is determined to have a single diameter in order to permanently hold the core fibers 5701-5704.

[0100] See Figures 6A-6B According to some implementation schemes, it is shown that by Figures 1A-1B A flowchart illustrates an operational method for implementing an optical 3D shape sensing within a medical device monitoring system. Here, the catheter includes at least one septum spanning the diameter of the tubing wall and extending longitudinally to divide the tubing wall. A first microlumen is fabricated in the middle portion of the septum, wherein the first microlumen is coaxial with the central axis of the catheter tubing. The first microlumen is configured to hold a central core fiber. Two or more microlumens, in addition to the first microlumen, are positioned at different locations circumferentially spaced along the wall of the catheter tubing. For example, two or more of a second plurality of microlumens may be positioned in different quadrants along the periphery of the catheter wall.

[0101] Furthermore, each core fiber includes multiple sensors spatially distributed along its length, at least between the proximal and distal ends of the conduit tubing. This sensor array is distributed to position the sensors at different regions of the core fiber, enabling distributed strain measurements across the entire length or selected portions of the conduit tubing. These distributed measurements can be transmitted via reflected light of varying spectral widths (e.g., specific wavelengths or wavelength ranges), which undergo certain wavelength shifts based on the type and extent of strain.

[0102] According to one implementation scheme in the publicly available text, such as Figure 6AAs shown, for each core fiber, broadband incident light is provided to propagate through the particular core fiber (block 600). Unless discharged, as the incident light reaches a sensor of the distributed sensor array measuring strain on the particular core fiber, the light of the prescribed spectral width associated with the first sensor will be reflected back to the optical receiver within the console (blocks 605-610). Here, the sensor alters a characteristic of the reflected light signal to identify the type and extent of strain on the particular core fiber measured by the first sensor (blocks 615-620). According to one embodiment of the disclosure, the alteration of the characteristic of the reflected light signal can represent a shift in the wavelength of the reflected light signal relative to the wavelength of the incident light signal associated with the prescribed spectral width. The sensor returns the reflected light signal through the core fiber, and the remaining spectrum of the incident light continues to propagate through the core fiber toward the distal end of the catheter tubing (blocks 625-630). The remaining spectrum of the incident light can encounter other sensors of the distributed sensor array, where each of these sensors will operate as set forth in blocks 605-630 until the last sensor of the distributed sensor array returns a reflected light signal associated with its designated spectral width and the remaining spectrum is discharged as illumination.

[0103] Referring now to Figure 6B During operation, a plurality of reflected light signals are returned to the console from each of a plurality of core fibers located within a corresponding plurality of micro-lumens formed within a catheter, such as the catheter of FIG. 1. Specifically, the optical receiver receives reflected light signals from the distributed sensor array located on the central core fiber and the outer core fibers and converts the reflected light signals to reflected data, i.e., electrical signals representative of the reflected light signals, including the wavelength shift caused by strain (blocks 650-655). The reflected data sorting logic is configured to identify which core fibers belong to which reflected data and divide the reflected data provided from the reflected light signals belonging to a particular measurement region (or similar spectral width) into analysis groups (blocks 660-665). Figure 1B

[0104] The reflected data of each analysis group is provided to the shape sensing logic for analysis (block 670). Here, the shape sensing logic compares the wavelength shift at each outer core fiber to the wavelength shift at the central core fiber, which is positioned along the central axis and operates as the neutral axis of bending (block 675). From these analyses, for all analysis groups (e.g., reflected light signals from sensors in all or most of the core fibers), the shape sensing logic can determine the shape assumed by the core fibers in three-dimensional space, from which the shape sensing logic can determine the current physical state of the catheter in three-dimensional space (blocks 680-685).

[0105] Referring to Figure 7 According to some embodiments, a method of determining a physical state of a catheter in three-dimensional space is shown Figure 1A ​An exemplary embodiment of the medical device monitoring system during catheter operation and insertion into a patient. Here, the catheter 195 generally includes an integrated tubing having a proximal portion 720 that is generally kept outside of the patient 700 and a distal portion 730 that generally resides within the patient's vasculature after placement is complete (where the catheter 195 enters the vasculature at the insertion site 710). The stylet 120 can be advanced through the catheter 195 to a desired location within the patient's vasculature such that the distal end (or tip) 735 of the stylet 120 (and thus the distal end of the catheter 195) is proximate to the patient's heart, such as in the lower one-third (1 / 3) portion of the superior vena cava (SVC). For this embodiment, various devices can be placed at the distal end 735 of the stylet 120 and / or catheter 195 to measure blood pressure in certain chambers of the heart and in blood vessels, to view the interior of blood vessels, etc.

[0106] The console connector 133 enables the stylet 120 to be operatively connected to the console 110 via the interconnect 145. Figure 1A ) Here, the connector 146 is configured to engage (mate) with the console connector 133 to allow light to propagate between the console 110 and the stylet assembly 119 (and in particular the stylet 120) and electrical signals to propagate from the stylet 120 to the console 110.

[0107] During advancement of the stylet 120, the distal tip 735 generally fluctuates due to factors such as blood flow and blood pressure within the blood vessel. These fluctuations can be movement of the distal portion of the stylet 120 in any direction. Generally, the movement is relatively small compared to the overall advancement of the stylet 120 (and catheter 195); however, such movement is detectable by the sensors integrated into the core fiber of the stylet 120.

[0108] The fluctuations can vary based on the blood vessel in which the stylet 120 (and catheter 195) is being advanced due to one or more of the physical characteristics of the blood vessel, the location of the blood vessel (and its proximity to the patient's heart), and any defects affecting the blood vessel (e.g., vessel stenosis, vessel spasm, occlusion, etc.). As will be discussed in further detail below, the volume of the blood vessel can affect the fluctuations (e.g., a larger diameter can provide for larger fluctuations). Similarly, the turbulence of the blood flow generally affects the fluctuations (e.g., higher turbulence generally equates to larger fluctuations). Relatedly, the proximity of the distal tip 735 to the patient's heart can affect the fluctuations due to the turbulent blood flow emanating from the right atrium of the heart and flowing through the SVC (see Figure 8A ). The blood pressure within the blood vessel can also affect the tip fluctuations. Furthermore, various defects can affect the fluctuations of the distal tip 735 and cause fluctuations that are different than what would be expected when the stylet 120 is advanced through a healthy blood vessel. Figures 8B-8DExamples of the stylet 120 being advanced toward various defects are provided.

[0109] Referring now to Figure 8A A detailed view of a stylet being advanced within a superior vena cava (SVC) 800 toward a right atrium of a patient is shown, in accordance with some embodiments. Figure 8A A detailed perspective view of the vasculature proximate to a heart 803 of a patient, as well as the anatomical structure of the heart 803, is shown. In particular, as the stylet 120 approaches the right atrium 804 through the SVC 800, the stylet 120 can be advanced into the right atrium 804 or into the azygos vein 802. The stylet 120 is generally used to locate a particular point in the vasculature at which the catheter 195 can be used to administer a medical procedure or medication, which can be referred to as a "target site" 805.

[0110] In some embodiments, the tip fluctuation logic 198 is configured to confirm the location of the distal tip 735 of the stylet 120 (which, in turn, corresponds to the distal tip of the catheter 195, within a predetermined distance, such as approximately 1-2 cm) as the catheter 195 and the stylet 120 are advanced through the vasculature of the patient toward the target site 805. In accordance with one embodiment of the disclosure, the tip fluctuation logic 198 is configured to analyze a subset of the wavelength shifts measured by the sensors disposed in each of the core fibers 137 (e.g., the sensors included in the distal portion 801 of the stylet 120). In some embodiments, the distal portion 801 includes a plurality of sensors, such as 50, 30, 10, 5, 3, etc. It should be noted that the disclosure is not limited to the stated number of sensors, and such statements should be understood to provide merely exemplary examples. Moreover, in some embodiments, the number of sensors included in the distal portion 501 and thus utilized by the tip fluctuation logic 198 can be dynamically configurable during runtime. Thus, a user can provide user input to the console 110 to adjust the number of sensors utilized by the tip fluctuation logic 198. As a result, the user can vary the specificity of the analysis performed by the tip fluctuation logic 198 during runtime (e.g., where utilization of a smaller number of sensors can correspond to a more specific analysis with respect to fluctuations at the distal tip 735).

[0111] In particular, the tip fluctuation logic 198 is configured to analyze the wavelength shifts measured by the sensors of the core fibers 137 located within the distal portion 801, which corresponds to the tip fluctuation analysis discussed above. Referring to Figure 8AAs the distal tip 735 of the stylet 120 is advanced through the SVC 800 toward the target site 805 within the right atrium 804, the sensors within the distal portion 801 can detect an increase in movement corresponding to an increase in tip fluctuations. The increase in tip fluctuations can be caused by turbulent flow of blood exiting the right atrium and entering the SVC (thus, the stylet 120 is traveling in a direction opposite the blood flow). Thus, the increase in fluctuations can provide the tip fluctuation logic 198 with an indication that the distal tip 735 is approaching the right atrium 804.

[0112] In one embodiment, the tip fluctuation logic 198 can be configured to correlate the detected wavelength shift received from the sensors within the distal portion 801 with data from the empirical knowledge repository 193 that corresponds to previously detected wavelength shifts received from sensors within similar distal portions of stylets. Based on the correlation, the tip fluctuation logic 198 can determine that the distal tip 735 is within the SVC 800, within a certain distance to the right atrium 804 or the target site 805, or within the right atrium 804. In one example, the determination can be based on whether the correlation indicates that the detected wavelength shift correlates to any previously detected wavelength shifts corresponding to the SVC 800, the target site 805, or the right atrium 804 by more than or equal to a threshold value.

[0113] In other embodiments, the detected wavelength shift received from the sensors within the distal portion 801 can be used by the tip fluctuation logic 198 as an input to a trained machine learning model that, when processed, provides a correlation to one or more previously detected fluctuations corresponding to the SVC 800, the target site 805, or the right atrium 804. Then, as described above, a similar threshold determination can be made by the tip fluctuation logic 198.

[0114] In embodiments in which an ECG signal can be obtained through the stylet 120 (or the catheter 195), the ECG signal can provide an indication of a rhythm pulse of the heart 803. The tip fluctuation logic 198 can compare the rhythm pulse indicated by the ECG signal to the detected wavelength shift received from the sensors within the distal portion 801 to determine whether the detected wavelength shift indicates motion that correlates to the rhythm pulse by at least a threshold value.

[0115] In some embodiments, tip confirmation can be used in conjunction with the shape sensing functionality discussed above in which the shape sensing logic 194 determines the current physical state of the stylet 120 (and thus the catheter 195) in 3D space for presentation on the display 170. In addition, in some embodiments, the catheter 195 and / or stylet 120 can include a pressure sensor configured to detect blood pressure within a blood vessel (or heart chamber) in which the distal tip 735 is placed. The detected blood pressure can also be used in the correlations discussed herein such that the tip fluctuation logic 198 can correlate the detected blood pressure with previously detected blood pressures to help determine placement of the distal tip 735 and / or detect defects affecting the blood vessel.

[0116] In some embodiments, the tip fluctuation logic 198 can detect or provide data for detecting placement of the distal tip 735 in the azygos vein 802. For example, the tip fluctuation logic 198 can detect fluctuations related to placement within the SVC 800 and subsequently detect a reduction in the fluctuations such that the detected fluctuations are no longer related to placement within the SVC 800 but rather within the azygos vein 802. For example, upon detecting a reduction in the fluctuations, the tip fluctuation logic 198 can perform a correlation between the detected fluctuations and previously detected fluctuations known to correspond to the azygos vein. The reduction in fluctuations of the distal tip 735 within the azygos vein 802 as compared to within the SVC 800 can be due to the smaller diameter of the azygos vein 802 and less turbulent flow within the azygos vein 802. The detection can optionally be confirmed by detecting a direction of blood flow. Specifically, if the distal tip 735 of the stylet 120 is pushed into the azygos vein 802, the stylet 120 will be pushed in a direction of blood flow indicating that the stylet 120 has deviated from the SVC 800.

[0117] In some embodiments, the tip fluctuation logic 198 can generate a graph illustrating the detected tip fluctuations compared to previously detected tip fluctuations and / or the rhythmical pulses of the heart. In one embodiment, such a graph can include a dynamic visualization of the current distal tip movement according to the detected fluctuations adjacent to the distal tip movement according to the previously detected tip fluctuations.

[0118] Referring to Figures 8B-8D A graph is provided illustrating the stylet 120 advancing through a vessel of the patient's vasculature and encountering a defect affecting the vessel. The stylet 120 can advance through a vessel (not shown for clarity) within the catheter 195. With specific reference to Figure 8BAccording to some embodiments, a side view of a stylet 120 being advanced through a vessel of a patient's vasculature toward a constriction in the vessel is shown. The stylet 120 is shown being advanced through a vessel 814 toward a constriction 815, which can be a vascular constriction, e.g., a constriction of a capillary or arteriole. In some embodiments, a vascular constriction can result in an elevated blood pressure level.

[0119] As the stylet 120 is advanced through the vessel 814, the console 110 receives reflected light from the sensors positioned along the core fiber 137. As discussed above, the tip fluctuation logic 198 can perform analysis on the wavelength shifts detected by a subset of the sensors, particularly those disposed in the distal portion of the stylet 120, such as those disposed in the distal portion 801 of the stylet 120. Figure 8A As the stylet 120 is advanced toward the constriction 815, the fluctuations of the distal tip 735 change due to the characteristics of the vessel, such as a narrowing in diameter and a reduction in blood flow. Thus, by monitoring the tip fluctuations of the distal tip 735 during advancement, the tip fluctuation logic 198 can detect an unexpected change (decrease) in tip fluctuations (e.g., not based on a change in entering a new vessel). Then, for defects in the vessel that are vascular constrictions, such as in the constriction 815, the tip fluctuation logic 198 can correlate the detected wavelength shifts corresponding to the decrease in fluctuations with previously detected wavelength shifts. This correlation can be performed in any manner discussed herein, including, for example, via a machine learning model. Figure 8B

[0120] When the tip fluctuation logic 198 determines that the correlation result is above a threshold, a warning or notification can be generated and provided to the user. The warning or notification can be audible or visual and can be displayed on the display 170 of the console 110. In some embodiments, the shape sensing functionality of the shape sensing logic 194 discussed above can be combined with the correlation performed by the tip fluctuation logic 198 to provide an indication to the user of the location of the constriction 815 (or other defects discussed below).

[0121] Reference is made to Figure 8C ​FIG. 12 shows a side view of a stylet being advanced through a vessel of a patient’s vasculature toward a vasospasm affecting the vessel, in accordance with some embodiments. The stylet 120 is shown being advanced through a vessel 816 toward a vasospasm 817, which can be due to arterial spasm. As the stylet 120 is advanced through the vessel 816, the control console 110 receives reflected light from the sensors positioned along the core fiber 137. As the stylet 120 is advanced toward the vasospasm 817, the fluctuations of the distal tip 735 change due to characteristics of the vessel, such as narrowing in diameter and reduced blood flow. Thus, by monitoring the tip fluctuations of the distal tip 735 during advancement, the tip fluctuation logic 198 can detect an unexpected change (e.g., an increase) in tip fluctuations due to a spasm (e.g., constriction) of the vessel wall (e.g., not based on a change into a new vessel). Then, for defects affecting the blood vessel (e.g., the defect in the vasospasm in FIG. 12), the tip fluctuation logic 198 can correlate the detected shift in wavelength corresponding to a decrease in fluctuations with previously detected shifts in wavelength. This correlation can be performed in any of the ways discussed herein, including, for example, via a machine learning model. A warning or notification can be generated in a similar manner as described above. Figure 8C FIG. 13 shows a side view of a stylet being advanced through a vessel of a patient’s vasculature toward an occlusion affecting the vessel, in accordance with some embodiments. The stylet 120 is shown being advanced through a vessel 818 toward an occlusion 819 (e.g., a blockage or clot due to blood accumulation, blood clots, etc.). As the stylet 120 is advanced through the vessel 818, the control console 110 receives reflected light from the sensors positioned along the core fiber 137. As the stylet 120 is advanced toward the occlusion 819, the fluctuations of the distal tip 735 change due to characteristics of the vessel, such as narrowing in diameter and reduced blood flow. Thus, by monitoring the tip fluctuations of the distal tip 735 during advancement, the tip fluctuation logic 198 can detect an unexpected change (a decrease) in tip fluctuations (e.g., not based on a change into a new blood vessel). Then, for defects affecting the vessel (e.g., the defect in the occlusion in FIG. 13), the tip fluctuation logic 198 can correlate the detected shift in wavelength corresponding to a decrease in fluctuations with previously detected shifts in wavelength. This correlation can be performed in any of the ways discussed herein, including, for example, via a machine learning model. Additionally, for the advancement of the stylet 120 toward the occlusion 819, the distal tip 735 can come into contact with the occlusion 819, causing the fluctuations to stop. Thus, detection that the fluctuations have stopped can be a factor in the correlation performed by the tip fluctuation logic 198. A warning or notification can be generated in a similar manner as described above.

[0122] Referring to FIG. 14, a side view of a stylet being advanced through a vessel of a patient’s vasculature toward a thrombus affecting the vessel is shown, in accordance with some embodiments. The stylet 120 is shown being advanced through a vessel 820 toward a thrombus 821 (e.g., a blood clot). As the stylet 120 is advanced through the vessel 820, the control console 110 receives reflected light from the sensors positioned along the core fiber 137. As the stylet 120 is advanced toward the thrombus 821, the fluctuations of the distal tip 735 change due to characteristics of the vessel, such as narrowing in diameter and reduced blood flow. Thus, by monitoring the tip fluctuations of the distal tip 735 during advancement, the tip fluctuation logic 198 can detect an unexpected change (e.g., an increase) in tip fluctuations due to a thrombus (e.g., not based on a change into a new vessel). Then, for defects affecting the blood vessel (e.g., the defect in the thrombus in FIG. 14), the tip fluctuation logic 198 can correlate the detected shift in wavelength corresponding to a decrease in fluctuations with previously detected shifts in wavelength. This correlation can be performed in any of the ways discussed herein, including, for example, via a machine learning model. A warning or notification can be generated in a similar manner as described above. Figure 8D Figure 8D FIG. 15 shows a side view of a stylet being advanced through a vessel of a patient’s vasculature toward a thrombus affecting the vessel, in accordance with some embodiments. The stylet 120 is shown being advanced through a vessel 822 toward a thrombus 823 (e.g., a blood clot). As the stylet 120 is advanced through the vessel 822, the control console 110 receives reflected light from the sensors positioned along the core fiber 137. As the stylet 120 is advanced toward the thrombus 823, the fluctuations of the distal tip 735 change due to characteristics of the vessel, such as narrowing in diameter and reduced blood flow. Thus, by monitoring the tip fluctuations of the distal tip 735 during advancement, the tip fluctuation logic 198 can detect an unexpected change (a decrease) in tip fluctuations (e.g., not based on a change into a new blood vessel). Then, for defects affecting the vessel (e.g., the defect in the thrombus in FIG. 15), the tip fluctuation logic 198 can correlate the detected shift in wavelength corresponding to a decrease in fluctuations with previously detected shifts in wavelength. This correlation can be performed in any of the ways discussed herein, including, for example, via a machine learning model. Additionally, for the advancement of the stylet 120 toward the thrombus 823, the distal tip 735 can come into contact with the thrombus 823, causing the fluctuations to stop. Thus, detection that the fluctuations have stopped can be a factor in the correlation performed by the tip fluctuation logic 198. A warning or notification can be generated in a similar manner as described above.

[0123] ​While certain specific embodiments have been disclosed herein, and while the detailed description has focused on particular embodiments, the particular embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications of the specific embodiments can and can be made without departing from the scope of the concepts provided herein. Thus, while the concept has been disclosed with particular emphasis on the specific embodiments, the concept has application in more general contexts.

Claims

1. A medical device system for detecting fluctuations using optical fiber technology of a medical device, characterized by, The medical device system includes: The medical device, which includes an optical fiber having one or more core fibers, each of the one or more core fibers including a plurality of sensors distributed along a longitudinal length of the respective core fiber, and each of the plurality of sensors being configured to: (i) reflect a light signal of a different spectral width based on received incident light; and (ii) change a characteristic of the reflected light signal based on a strain experienced by the optical fiber; and A console including one or more processors and a non-transitory computer- readable medium having stored thereon logic that, when executed by the one or more processors, causes operations including: providing a broadband incident light signal to the optical fiber; receiving reflected light signals of different spectral widths of the broadband incident light reflected by one or more of the plurality of sensors; processing the reflected light signals associated with the one or more core fibers to detect a fluctuation of a portion of the optical fiber; and based on the detected fluctuation, determining a location of the portion of the optical fiber or determining a defect affecting a vessel in which the portion is disposed, wherein determining the location of the portion of the optical fiber includes: obtaining an electrocardiogram signal, associating the electrocardiogram signal with the detected fluctuation to identify whether the detected fluctuation includes motion according to a rhythm pattern of the electrocardiogram signal, and determining whether an association result is above a first threshold.

2. The medical device system of claim 1, wherein, The portion of the optical fiber is a distal tip.

3. The medical device system of claim 1, wherein, The optical fiber is a multicore optical fiber including a plurality of core fibers.

4. The medical device system of claim 1, wherein, The defect is selected from the group consisting of a constriction of a vessel, a spasm of a vessel, and an occlusion in a vessel.

5. The medical device system of claim 1, wherein, determining includes: associating the reflected light signals with previously obtained reflected light signals to identify the location of the portion of the optical fiber or to identify the defect affecting the vessel, and determining whether an association result is above a first threshold.

6. The medical device system of claim 5, wherein, The associating is performed by a machine learning technique.

7. The medical device system of claim 1, wherein, The medical device is one of a guidewire, a wire, a stylet, a stylet within a needle, a needle of an optical fiber having a sheath embedded with the needle, or a catheter of an optical fiber having one or more walls of the catheter embedded with.

8. The medical device system of claim 1, wherein, Each of the plurality of sensors is a reflective grating, wherein each reflective grating changes its reflected light signal by applying a wavelength shift that depends on a strain experienced by the reflective grating.

9. The medical device system of claim 1, wherein, When executed by the one or more processors, the logic causes further operations including generating a warning indicating that the defect is present.

10. The medical device system of claim 9, wherein, The warning includes an indication of a location of the defect.

11. A non-transitory computer-readable medium having stored thereon logic, the logic comprising: When executed by the one or more processors, the logic causes operations including: providing a broadband incident light signal to an optical fiber included within a medical device, wherein the optical fiber includes one or more core fibers, each of the one or more core fibers including a plurality of reflective grating fibers distributed along a longitudinal length of the respective core fiber, and each of the plurality of reflective gratings being configured to: (i) reflect a light signal of a different spectral width based on received incident light; and (ii) change a characteristic of the reflected light signal based on a strain experienced by the optical fiber; and ​ receiving reflected light signals of different spectral widths of broadband incident light reflected by one or more of a plurality of sensors; processing the reflected light signals associated with the one or more core fibers to detect a fluctuation of a portion of the optical fiber; and based on the detected fluctuation, determining a location of the portion of the optical fiber or determining a defect affecting a vessel in which the portion is disposed, wherein determining the location of the portion of the optical fiber comprises: obtaining an electrocardiogram signal; associating the electrocardiogram signal with the detected fluctuation to identify whether the detected fluctuation includes motion according to a rhythm pattern of the electrocardiogram signal; and determining whether the association result is above a first threshold.

12. The non-transitory computer-readable medium of claim 11, wherein, the portion of the optical fiber is a distal tip.

13. The non-transitory computer-readable medium of claim 11, wherein, the optical fiber is a multicore optical fiber comprising a plurality of core fibers.

14. The non-transitory computer-readable medium of claim 11, wherein, the defect is selected from the group consisting of a constriction of a vessel, a spasm of a vessel, and an occlusion in a vessel.

15. The non-transitory computer-readable medium of claim 11, wherein, determining comprises: associating the reflected light signals with previously obtained reflected light signals to identify the location of the portion of the optical fiber or to identify the defect affecting a vessel; and determining whether the association result is above a first threshold.

16. The non-transitory computer-readable medium of claim 15, wherein, the associating is performed by a machine learning technique.

17. The non-transitory computer-readable medium of claim 11, wherein, the medical device is one of a guidewire, a wire, a stylet, a stylet within a needle, a needle of an optical fiber having a sleeve embedded in the needle, or a catheter of an optical fiber having one or more walls of the catheter embedded in a catheter.

18. The non-transitory computer-readable medium of claim 11, wherein, each of the plurality of sensors is a reflective grating, wherein each reflective grating changes its reflected light signal by applying a wavelength shift, the wavelength shift depending on a strain experienced by the reflective grating.

19. The non-transitory computer-readable medium of claim 11, wherein, when executed by the one or more processors, the logic causes further operations comprising generating a warning indicating that the defect is present.

20. The non-transitory computer-readable medium of claim 19, wherein, the warning includes an indication of a location of the defect.

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