Continuous fiber optic function monitoring and self-diagnostic reporting system

Abstract

The present application is entitled Continuous Fiber Function Monitoring and Self-Diagnostic Reporting System. The optical fiber includes one or more core fibers, each of which includes a plurality of sensors configured to: (i) reflect light signals based on received incident light; and (ii) alter the reflected light signals for use in determining a physical state of the multi-core optical fiber. The system further includes a console having a non-transitory computer readable medium storing logic that, when executed, causes operations of: providing a broadband incident light signal to the multi-core optical fiber; receiving reflected light signals; receiving reflected light signals of different spectral widths of the broadband incident light by one or more of the plurality of sensors; identifying at least one unexpected spectral width or lack of an expected spectral width; and determining, based on the identifying, that a damage has occurred to the optical fiber.

Description

[0001] Priority

[0002] This application claims priority benefit of U.S. Provisional Application No. 63 / 050,641, filed July 10, 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 continuous fiber functional monitoring and self-diagnostic reporting system. BACKGROUND

[0004] In the past, certain intravascular guidance of medical devices, such as guidewires and catheters, have employed 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 a 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 limited depth range.

[0007] Disclosed herein is a fiber shape sensing system and method performed thereby, wherein the system is configured to provide confirmation or tracking information of tip placement using fiber optic technology. Additionally, the system is configured to detect damage to one or more core fibers, and optionally detect a location of the damage along the core fiber(s). Some embodiments combine fiber shape sensing functionality with one or more of intravascular electrocardiogram (ECG) monitoring, impedance / conductance sensing, and blood flow orientation detection. SUMMARY

[0008] Briefly, the embodiments disclosed herein relate to obtaining three-dimensional (3D) information (reflected light) corresponding to the trajectory and / or shape of a medical instrument such as a catheter, guidewire, or stylet via an optical fiber core during advancement through a patient's vasculature, monitoring the health of the optical fiber core, and determining when the optical fiber core kinks or is damaged.

[0009] More particularly, in some embodiments, the medical instrument includes a core optical fiber configured with an array of sensors (reflective gratings) spatially distributed over a prescribed length of the core fiber to generally sense external strain on those regions of the core fiber occupied by the sensors. The optical fiber core is configured to receive broadband light from a console during advancement through a patient's vasculature, where the broadband light propagates along at least a portion of the distance of the optical fiber core toward the distal end. With each sensor positioned along the optical fiber core configured to reflect a different specific spectral width of light, the array of sensors enables distributed measurements to be made throughout the prescribed length of the multi-core optical fiber. These distributed measurements can include wavelength shifts having a correlation to 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 console. The physical state of the medical instrument can be determined based on analysis of the wavelength shifts 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 result in wavelength changes (shifts) 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 particularly damage) occurring in each optical fiber core of a medical device are discussed below, including (i) a single core fiber and (ii) multiple core fibers.

[0012] Particular 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 in which the stylet is disposed (such as a catheter) within a patient. A guidewire can be substituted for 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 disclosed herein relating to detecting health of the optical fiber core 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 the catheter comprising 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 catheter within the patient (hereinafter described 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 the broadband incident light propagating along a core (hereinafter referred to as “core fiber”) of the multicore optical fiber that is reflected back over the core fiber by a particular sensor located on the core fiber. One illustrative embodiment of the returned information can involve a change in the signal characteristics 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 a plurality of sensors and each sensor is configured to reflect incident light of a different spectral range (e.g., different ranges of light frequencies). Based on the type and extent of strain exerted on each core fiber, the sensor associated with that core fiber can change (shift) the wavelength of the reflected light to convey 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 is paired 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 strains on those regions of the core fiber occupied by the sensors. With each sensor located 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 the strains 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 sensor operates as a mirror 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 the optical light source and propagates through the particular core fiber, once reaching the first sensor of the distributed sensor array for that core fiber, the light of the prescribed spectral width associated with the first sensor is reflected back to the optical receiver within the console, which includes a display and the optical light source. The remaining spectrum of the incident light continues to propagate through the core fiber towards 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 a distributed measurement, 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 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 light wavelength or range of light 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 (operating as a reference) 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, the clinician can rely on the 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 peripheral core fiber 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] Certain embodiments of the disclosure relate to tracking advancement of an implementation subject through a patient's vasculature using fiber optic shape sensing, and detecting damage to one or more core fibers of a fiber optic integrated into the implementation subject. For example, as described above, each core fiber includes a plurality of reflective gratings disposed along its length, where each reflective grating receives a broadband incident light and reflects a light signal having a particular spectral width (e.g., a particular wavelength or a particular range of wavelengths) that can be shifted based on an amount of strain applied to a length of the core fiber corresponding to the reflective grating. Damage detection of the core fibers is performed by analyzing the received reflective light signals, and specifically identifying the reflective gratings from which a damaged or degraded reflective light signal is received, a reflective light signal is received with a reduced intensity (e.g., power transmitted per unit area), or no reflective light signal is received.

[0020] Additionally, some embodiments include analyzing the particular spectral width of each received reflective light signal to determine a location along the core fiber where damage (or kink) occurred. Specifically, the logic of the console determines from which core fiber each reflective light signal is received, and further analyzes the particular spectral width of each received reflective light signal to identify: (i) a distal-most reflective grating from which a normal, undamaged light signal is received; and (ii) a proximal-most reflective grating from which a damaged (e.g., degraded) light signal is received. Identification of such reflective gratings results in identification of a location of a kink or damage point.

[0021] Other embodiments disclosed herein relate to identifying damage to a core fiber and its location using fiber optic shape sensing, and detecting a waviness of the implementation subject. For example, a deviation of advancing the implementation subject off of the SVC into the anomalous vein is identified via a reduction in the waviness of the implementation subject. Additionally, intravascular ECG monitoring can be combined with either or both of the fiber optic shape sensing methods mentioned above to detect a deviation of the implementation subject into the anomalous vein when a slight reduction in the amplitude of the P-wave of the detected intravascular ECG, even when the implementation subject is being advanced toward the sinoatrial (SA) node. Additionally or in the alternative, impedance / conductance sensing can be combined with either or both of the fiber optic shape sensing methods and, optionally, the ECG intravascular ECG monitoring to detect a deviation of the implementation subject into the anomalous vein. For example, the smaller diameter vessel is characterized by a changing impedance / conductance when the implementation subject deviates into the anomalous vein.

[0022] In other embodiments, the direction of blood flow can be used in combination with any of the fiber optic shape sensing methods, intravascular ECG monitoring, and / or impedance / conductance sensing mentioned above. For example, the blood flow will change from being in line with the advancement of the implementation subject to being counter to the advancement of the implementation subject when the implementation subject deviates into the anomalous vein, which can be detected using a pulse oximeter and / or blood flow Doppler.

[0023] Some embodiments include a medical device system for detecting damage to a medical device using fiber optic technology, where the system includes 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 is configured to: (i) reflect a light signal of a different spectral width based on a received incident light; and (ii) change a characteristic of the reflected light signal for use in determining a physical state of the optical fiber. The system can also 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 a broadband incident light signal to the optical fiber; receiving, by one or more of the plurality of sensors, reflected light signals of different spectral widths of the broadband incident light; processing the reflected light signals associated with the one or more core fibers to identify at least one unexpected spectral width or to identify a lack of an expected spectral width; and determining, based on the identifying the at least one unexpected spectral width or the identifying the lack of the expected spectral width, that one or more of the core fibers has incurred damage.

[0024] In some embodiments, the unexpected spectral width is a spectral width that is not configured to be used by any of the plurality of sensors of the core fiber. In some embodiments, the optical fiber is a single-core optical fiber. In other embodiments, the optical fiber is a multi-core optical fiber including a plurality of core fibers. In some embodiments, the damage affects a first subset of the plurality of core fibers.

[0025] In some embodiments, a second subset of the plurality of core fibers is not affected by the damage such that the multi-core optical fiber maintains at least partial functionality based on the second subset of the plurality of core fibers. In some embodiments, the at least partial functionality includes one or more of: fluctuation sensing of a distal tip of the medical device, shape sensing of the multi-core optical fiber, blood oxygen monitoring, distal tip confirmation, distal tip position detection, detection of the distal tip of the medical device entering the azygos vein, impedance or conduction sensing, intravascular ECG monitoring, or vessel cannulation detection.

[0026] In further embodiments, the logic, when executed by the one or more processors, causes further operations including performing the at least partial functionality of the multi-core optical fiber without regard to information provided by the first core fiber that has reflected the light signal having the first unexpected wavelength. In some embodiments, the second subset of the plurality of core fibers includes a redundant core fiber such that a shape sensing functionality of the multi-core optical fiber is maintained. In other embodiments, the medical device is one of: a guide wire, a guide wire, a stylet, a stylet within a needle, a needle of an optical fiber having a cannula embedded within the needle, or a catheter of an optical fiber having one or more walls of a catheter embedded within.

[0027] In some embodiments, when executed by the one or more processors, the logic causes further operations including determining a first core fiber affected by the damage, and determining a location of the damage along the first core fiber. In some embodiments, determining the first core fiber is based on an association of a unique identifier assigned to the first core fiber and the unique identifier to each optical signal reflected by the first core fiber. In some embodiments, determining the location of the damage includes identifying (i) a distal-most sensor of the first core fiber from which a first optical signal having an expected spectral width is received; and (ii) a proximal-most sensor of the first core fiber from which a second optical signal having a first non-expected spectral width is received, from which a second optical signal having a reduced intensity is received, or from which a corresponding expected spectral width is not received. In some embodiments, each of the plurality of sensors is a reflective grating, wherein each reflective grating changes its reflected optical signal by applying a wavelength shift that depends on a strain experienced by the reflective grating.

[0028] Some embodiments include a method for placing a medical device into a patient, the method including certain operations including providing a broadband incident light signal to an optical fiber included within the 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 gratings distributed along a longitudinal length of the respective core fiber, and each of the plurality of reflective gratings is configured to: (i) reflect an optical signal of a different spectral width based on a received incident light; and (ii) change a characteristic of the reflected optical signal for use in determining a physical state of the optical fiber and receiving the reflected optical signal of the different spectral width of the broadband incident light by one or more of the plurality of sensors. The operations further include processing the reflected optical signals associated with the one or more core fibers to identify at least one non-expected spectral width or a lack of an expected spectral width, and determining that one or more of the core fibers has experienced damage based on identifying the at least one non-expected spectral width or the lack of the expected spectral width.

[0029] In some embodiments, the non-expected spectral width is a spectral width that is not configured to be used by any of the plurality of sensors of the core fiber. In some embodiments, the optical fiber is a single-core optical fiber. In other embodiments, the optical fiber is a multi-core optical fiber including a plurality of core fibers. In some embodiments, the damage affects a first subset of the plurality of core fibers.

[0030] In some embodiments, a second subset of the plurality of core fibers is not affected by the damage, such that the multi-core optical fiber maintains at least a partial functionality based on the second subset of the plurality of core fibers. In some embodiments, the at least partial functionality includes one or more of: fluctuation sensing of a distal tip of the medical device, shape sensing of the multi-core optical fiber, blood oxygen monitoring, distal tip confirmation, distal tip location detection, detection of the distal tip of the medical device into the azygos vein, impedance or conduction sensing, intravascular ECG monitoring, or vessel cannulation detection.

[0031] In further embodiments, when executed by the one or more processors, the logic causes further operations comprising performing at least a portion of the function of the multicore optical fiber without regard to information provided by the first core fiber that has reflected the optical signal having the first unexpected wavelength. In some embodiments, the second subset of the plurality of core fibers includes a redundant core fiber to maintain a shape sensing function of the multicore optical fiber. In other embodiments, the medical device is one of a guide wire, a guidewire, a stylet, a stylet within a needle, a needle having a sheath with an embedded optical fiber of the needle, or a catheter having one or more walls of the catheter embedded with an optical fiber.

[0032] In some embodiments, when executed by the one or more processors, the logic causes further operations comprising determining the first core fiber affected by the damage and determining a location of the damage along the first core fiber. In some embodiments, determining the first core fiber is based on an association of a unique identifier assigned to the first core fiber and each optical signal reflected by the first core fiber. In some embodiments, determining the location of the damage includes identifying (i) a distal-most sensor of the first core fiber from which a first optical signal having an expected wavelength is received and (ii) a proximal-most sensor of the first core fiber from which a second optical signal having a first unexpected spectral width, a second optical signal having a reduced intensity, or a second optical signal for which a corresponding expected spectral width is not received is received. In some embodiments, each of the plurality of sensors is a reflective grating, wherein each reflective grating changes its reflected optical signal by applying a wavelength shift that depends on a strain experienced by the reflective grating.

[0033] Some embodiments disclose a non-transitory computer-readable medium having logic stored thereon that, when executed by one or more processors, causes operations comprising 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 longitudinal length of the respective core fiber, and each of the plurality of reflective gratings is configured to: (i) reflect an optical signal of a different spectral width based on the received incident light and (ii) change a characteristic of the reflected optical signal for use in determining a physical state of the optical fiber and receiving the reflected optical signal of the different spectral width of the broadband incident light by one or more of the plurality of sensors. The operations further include processing the reflected optical signals associated with the one or more core fibers to identify at least one unexpected spectral width or a lack of an expected spectral width and determining that one or more of the core fibers has experienced damage based on the identification of the at least one unexpected spectral width or the lack of the expected spectral width.

[0034] In some embodiments, the unexpected spectral width is a spectral width that is not configured to be used by any of the plurality of sensors of the core fiber. In some embodiments, the optical fiber is a single-core optical fiber. In other embodiments, the optical fiber is a multi-core optical fiber comprising a plurality of core fibers. In some embodiments, the damage affects a first subset of the plurality of core fibers.

[0035] In some embodiments, a second subset of the plurality of core fibers is not affected by the damage, such that the multi-core optical fiber maintains at least partial functionality based on the second subset of the plurality of core fibers. In some embodiments, the at least partial functionality includes one or more of: fluctuation sensing of a distal tip of the medical device, shape sensing of the multi-core optical fiber, blood oxygen monitoring, distal tip confirmation, distal tip location detection, detection of the distal tip of the medical device entering the azygos vein, impedance or conduction sensing, intravascular ECG monitoring, or vessel cannulation detection.

[0036] In further embodiments, when executed by the one or more processors, the logic causes further operations including performing the at least partial functionality of the multi-core optical fiber without regard to information provided by the first core fiber that has reflected the optical signal having the first unexpected wavelength. In some embodiments, the second subset of the plurality of core fibers includes a redundant core fiber to maintain a shape sensing functionality of the multi-core optical fiber. In other embodiments, the medical device is one of: a guidewire, a guide wire, a stylet, a stylet within a needle, a needle of an optical fiber having a cannula embedded within the needle, or a catheter of an optical fiber having one or more walls of a catheter embedded within.

[0037] In some embodiments, when executed by the one or more processors, the logic causes further operations including determining the first core fiber affected by the damage and determining a location of the damage along the first core fiber. In some embodiments, determining the first core fiber is based on an association of a unique identifier assigned to the first core fiber and each optical signal reflected by the first core fiber. In some embodiments, determining the location of the damage includes: identifying (i) a distal-most sensor of the first core fiber from which a first optical signal having an expected wavelength is received; and (ii) a proximal-most sensor from which a second optical signal having a first unexpected spectral width is received, from which a second optical signal having a reduced intensity is received, or from which a corresponding expected spectral width is not received. In some embodiments, each of the plurality of sensors is a reflective grating, wherein each reflective grating changes its reflected optical signal by applying a wavelength shift that depends on a strain experienced by the reflective grating.

[0038] 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 for purposes of illustration only and do not exclude other implementations. BRIEF DESCRIPTION OF DRAWINGS

[0039] 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:

[0040] 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;

[0041] Figure 1B is an alternative illustrative embodiment of a medical instrument monitoring system 100 according to some embodiments;

[0042] 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 ;

[0043] Figure 3A is an exemplary embodiment of a structure of a portion of a multi-core fiber included within a stylet 120 of Figure 1A ;

[0044] Figure 3B is a cross-sectional view of a stylet of Figure 3A ;

[0045] Figure 4A is a second exemplary embodiment of a stylet of Figure 1B ;

[0046] Figure 4B is a cross-sectional view of a stylet of Figure 4A ;

[0047] Figure 5A is an elevational 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;

[0048] Figure 5B is a perspective view of a first illustrative embodiment of a catheter including a core fiber mounted within a micro-lumen according to some embodiments; Figure 5A ;

[0049] Figures 6A-6B is a flowchart of a method of operation to implement optical 3D shape sensing by a medical instrument monitoring system of Figures 1A-1B ;

[0050] Figure 7It is based on some implementation plans. Figure 1A An exemplary implementation of a medical device monitoring system during catheter manipulation and patient insertion;

[0051] Figure 8 It is based on some implementation plans, including Figure 1A An implementation scheme for a kinked or damaged portion of a single-core optical fiber within the core pin 120;

[0052] Figure 9A It is based on some implementation plans, including Figure 1A An implementation scheme for a kinked or partially damaged portion of a multi-core optical fiber within the core pin 120;

[0053] Figure 9B It is based on some implementation plans, including Figure 1A An implementation scheme for a structure of a portion of a completely damaged multi-core optical fiber within the core needle 120. Detailed Implementation

[0054] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be readily separated from the specific embodiments and optionally combined with or substituted for any feature of any of the many other embodiments disclosed herein.

[0055] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments, and that they do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or steps, and do not provide for a series or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in sequence, and a particular embodiment including these features or steps is not necessarily limited to these three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such markings are used to reflect, for example, relative positions, orientations, or directions. Unless the context clearly specifies otherwise, the singular forms “an,” “a,” and “the” include plural references.

[0056] “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.

[0057] “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.

[0058] 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. Embodiments 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.

[0059] 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

[0060] 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, where the stylet 120 is 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.

[0061] 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 embodiment of the console 110 is shown in U.S. Publication 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.

[0062] 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.

[0063] 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 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).

[0064] 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 optical fiber core 135 located within or as the stylet 120 operates, as follows. As discussed herein, the optical fiber core 135 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 optical fiber 135. From 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.

[0065] 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 optical fiber(s) 147 included in the interconnect 145, which are optically connected to the multi-core optical fiber core 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.

[0066] 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.

[0067] As shown, both the optical source 182 and the optical receiver 184 are operatively connected to the processor 160 that manages their operation. Further, the optical receiver 184 is operatively 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.

[0068] 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.

[0069] 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 multicore 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 multicore 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 multicore 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.

[0070] 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.

[0071] 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 measures and 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., the SVC, the inferior vena cava (IVC), the right atrium, the 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.

[0072] 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 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.

[0073] In some embodiments, e.g., those directed to tip location confirmation, the analysis of the fluctuation logic 198 can utilize the 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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 a "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 stylet 120 of Figure 1A .

[0078] The optical logic 180 is configured to support a graphical presentation 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 a wavelength shift 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 shift) to determine a 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 a fluctuation (real-time movement) of the tip (or distal end).

[0079] 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.

[0080] 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.

[0081] 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 shifts 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.

[0082] 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".

[0083] 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.

[0084] 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.

[0085] 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).

[0086] 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.

[0087] 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 the plurality of core fibers 1371-1374 M (M≥2; M=4). Although the multi-core optical fiber 135 is illustrated within four (4) core fibers 1371-1374, a greater number of core fibers 1371-1374 M (M>4) can be deployed to provide more detailed three-dimensional sensing of the physical state (e.g., shape, etc.) of the multi-core optical fiber 135 and the stylet 120.

[0088] For this embodiment of the disclosure, the multi-core optical fiber 135 is encapsulated within a concentric braided tubing 310 that is positioned above the low coefficient of friction layer 335. The braided tubing 310 can feature a "mesh" configuration in which the spacing between the intersecting conductive elements is selected based on the degree of rigidity required for the stylet 120, as greater spacing can provide less rigidity, and thus a more flexible stylet 120.

[0089] According to this embodiment of the disclosure, as Figures 3A-3B illustrated, the core fibers 1371-1374 include (i) a central core fiber 1371 and (ii) a plurality of peripheral core fibers 1372-1374 that are held within internal cavities 3201-3204 formed in the cladding 300. According to one embodiment of the disclosure, one or more of the internal cavities 3201-3204 can be configured with a diameter that is sized larger than the diameter of the core fibers 1371-1374. By avoiding direct physical contact of a majority of the surface area of the core fibers 1371-1374 with the wall surface of the internal cavities 3201-3204, the wavelength changes to the incident light caused by angular deviations in the multi-core optical fiber 135 are reduced, thereby reducing the effects of pressure and tension applied to the walls of the internal cavities 3201-320 M M themselves) of the core fibers 1371-137

[0090] As Figures 3A-3B further illustrated, the core fibers 1371-1374 can include a central core fiber 1371 that is positioned within a first internal cavity 3201 formed along the first neutral axis 230 and a plurality of core fibers 1372-1374 that are positioned within internal cavities 3202-3204 (each formed within a different region of the cladding 300 that diverges from the first neutral axis 230). Generally, the core fibers 1372-1374 (excluding the central core fiber 1371) can be positioned at different regions within the cross-sectional area 305 of the cladding 300 to provide sufficient spacing to enable three-dimensional sensing of the multi-core optical fiber 135 based on wavelength changes to the incident light that propagates through the core fibers 1372-1374 and reflects back to the console for analysis.

[0091] For example, the cladding 300 can feature a "mesh" configuration in which the spacing between the intersecting conductive elements is selected based on the degree of rigidity required for the stylet 120, as greater spacing can provide less rigidity, and thus a more flexible stylet 120.​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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] Referring to Figure 5A A front view of a first illustrative embodiment of a catheter including an integrated tubing, a diametrically disposed septum, and micro-lumens formed within the tubing and the septum is shown in accordance with some embodiments. Here, the catheter 130 includes an integrated tubing, a diametrically disposed septum 510, 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 septum 510 of the catheter 130. In particular, the septum 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 septum 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 septum 510.

[0096] In accordance with one embodiment of the present disclosure, the two lumens 540 and 545 have approximately the same volume. However, the septum 510 need not divide the tubing into two equal lumens. For example, instead of the septum 510 extending vertically (12 o'clock to 6 o'clock) from a forward-facing cross-sectional view of the tubing, the septum 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.

[0097] 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.

[0098] According to one implementation scheme in the publicly available text, such as Figure 5B 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.

[0099] See Figure 5A According to some implementation schemes, Figure 6A-6B 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.

[0100] As an alternative embodiment to the disclosure, the diameter dimension of one or more of the micro-lumens 5301-5304 is determined to have an excess over the diameter of the corresponding one or more core fibers 5701-5704. However, the dimension of at least one of the micro-lumens 5301-5304 is determined to fixedly retain its corresponding core fiber (e.g., the core fiber is retained without a spacing between its lateral surface and the inner wall surface of its corresponding micro-lumen). As yet another alternative embodiment to the disclosure, the dimensions of all of the micro-lumens 5301-5304 are determined to have one diameter to fixedly retain the core fibers 5701-5704.

[0101] Referring to Figures 1A-1B , a flowchart of an operational method of a medical instrument monitoring system of Figure 6A to implement optical 3D shape sensing is shown in accordance with some embodiments. Here, the catheter includes at least one diaphragm spanning the diameter of the tubing wall and longitudinally continuing to divide the tubing wall. A medial portion of the diaphragm is fabricated with a first micro-lumen, where the first micro-lumen is coaxial with a central axis of the catheter tubing. The first micro-lumen is configured to retain a central core fiber. Two or more micro-lumens other than the first micro-lumen are positioned at different locations spaced circumferentially along the wall of the catheter tubing. For example, two or more of the second plurality of micro-lumens can be positioned at different quadrants along the perimeter of the catheter wall.

[0102] Further, each core fiber includes a plurality of sensors spatially distributed along its length between at least the proximal and distal ends of the catheter tubing. The array of sensors is distributed to position sensors at different regions of the core fiber to enable distributed measurement of corresponding strain throughout the entire length or selected portions of the catheter tubing. This distributed measurement can be communicated by reflected light of different spectral widths (e.g., particular wavelengths or particular ranges of wavelengths) that experience certain wavelength shifts based on the type and extent of strain.

[0103] According to one embodiment of the disclosure, as Figure 6BAs shown, for each core fiber, broadband incident light is provided to propagate through the specific core fiber (box 600). Unless discharged, when the incident light reaches the sensor of the distributed sensor array measuring the strain on the specific core fiber, the light with a predetermined spectral width associated with the first sensor is reflected back to the optical receiver within the console (boxes 605-610). Here, the sensor modifies the characteristics of the reflected light signal to identify the type and extent of strain on the specific core fiber measured by the first sensor (boxes 615-620). According to one embodiment of the disclosed text, the change in the characteristics of the reflected light signal may represent a change (offset) in the wavelength of the reflected light signal relative to the wavelength of the incident light signal associated with the predetermined 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 conduit tubing (boxes 625-630). The remaining spectrum of the incident light may encounter other sensors in the distributed sensor array, each of which will operate as described in boxes 605-630, until the last sensor in the distributed sensor array returns a reflected light signal associated with its specified spectral width and the remaining spectrum is discharged as illumination.

[0104] See now Figure 1B During operation, multiple reflected light signals originate from the conduit (e.g., ...). Figure 7 Each of the multiple core fibers within the corresponding multiple microlumens formed within the conduit returns to the control console. Specifically, the optical receiver receives reflected light signals from a distributed sensor array located on the central and outer core fibers and converts the reflected light signals into reflected data, i.e., electrical signals representing the reflected light signals, including wavelength shifts caused by strain (boxes 650-655). Reflected data classification logic is configured to identify which core fibers belong to which reflected data and to group reflected data provided by reflected light signals belonging to a specific measurement region (or similar spectral width) into analysis groups (boxes 660-665).

[0105] The reflection data for each analysis group is provided to the shape sensing logic for analysis (box 670). Here, the shape sensing logic compares the wavelength offset at each outer core fiber with the wavelength offset at the central core fiber, which is positioned along the central axis and operates as a curved neutral axis (box 675). Based on this analysis, 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 adopted by the core fibers in three-dimensional space, thereby determining the current physical state of the catheter in three-dimensional space (boxes 680-685).

[0106] refer to Figure 1A According to some implementation schemes, Figure 8An exemplary embodiment of the medical device monitoring system during catheter operation and insertion into a patient is shown in FIG. 1. Here, a catheter 195 generally includes an integrated tube having a proximal portion 720 that is generally kept outside of a patient 700 and a distal portion 730 that generally resides within the patient's vasculature after placement is complete, with the catheter 195 entering the vasculature at an insertion site. A stylet 120 can be advanced through the catheter 195 to a desired location within the patient's vasculature such that a distal end (or tip) 735 of the stylet 120 (and thus a 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 instruments 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.

[0107] During advancement through the patient's vasculature, the stylet 120 receives the broadband incident light 155 from the console 110 via the optical fiber(s) 147 within the interconnect 145, with the incident light 155 propagating to the core fiber 137 within the stylet 120. According to one embodiment of the disclosure, the connector 146 of the interconnect 145 that terminates the optical fiber(s) 147 can be coupled to an optical-based catheter connector 144 that can be configured to terminate the core fiber 137 deployed within the stylet 120. Such a coupling optically connects the core fiber 137 of the stylet 120 with the optical fiber(s) 147 within the interconnect 145. The optical connectivity is required to propagate the incident light 155 to the core fiber 137 and to return the reflected light signal 150 through the interconnect 145 to the optical logic 180 within the console 110. The physical state of the stylet 120 can be determined based on analysis of the wavelength shift of the reflected light signal 150.

[0108] Reference is now made to Figure 2 , according to some embodiments, showing an embodiment of a structure including a kinked or damaged single-core optical fiber portion within a stylet 800. The single-core fiber portion 801 of the optical fiber 836 depicts a single core fiber 837 along with sensors (e.g., reflective gratings) 8101-810 N (N≥2) within the core fiber 837. As shown, the single-core optical fiber 836 included within the stylet 800 is similar to the multi-core fiber portion 200 of Figure 2 , such that the discussion of the functionality of the sensors (reflective gratings) 210 Figure 8 M 11 NM (N≥2; M≥2) applies to the reflective gratings 8101-810 N ​​​For example, the single-core optical fiber portion 801 is divided into a plurality of cross-sectional regions 8201-820 N where each cross-sectional region 8201-820 N corresponds to a reflective grating 8101-810 N Some or all of the cross-sectional regions 8201…820 N may be static (e.g., a prescribed length) or can be dynamic (e.g., the size varies among the regions 8201…820 N .

[0109] The core fiber 837 is positioned substantially along the central axis 830 within the cladding of the single-core optical fiber 836. As the stylet 800 operates, each of the reflective gratings 8101-810 N reflects light of a different spectral width. As shown, according to one embodiment of the disclosure, each of the gratings 8101-810 N is associated with a different particular spectral width, which will be represented by a different center frequency f1…f N , where adjacent spectral widths reflected by adjacent gratings are non-overlapping.

[0110] As a result, the reflected light returning allows information to be determined based on wavelength shifts (measured from the returning reflected light) that are indicative of the physical state of the single-core optical fiber 836 (and the stylet 800). Specifically, strain (e.g., compression or stretching) applied to the single-core optical fiber 836 causes a wavelength shift associated with the returning reflected light. Based on different locations, based on angular path changes as the stylet 800 is advanced in the patient, the core fiber 837 experiences different types and degrees of strain.

[0111] In a healthy operating state, the reflective gratings 8101-810 N receive the broadband incident light 155 and reflect light having different spectral widths, such that the logic of the console 110 can determine the physical state of the single-core optical fiber 836 (and the stylet 800). However, when the single-core optical fiber 836 becomes damaged or develops a kink, the reflection of the incident light 155 and the corresponding light signals by each of the reflective gratings 8101-810 N may be compromised, preventing the logic of the console 110 from determining the physical state of the single-core optical fiber 836 (and the stylet 800). In some cases, the incident light 155 is unable to propagate past the damage.

[0112] Specifically, Figure 9AA post-damage single-core optical fiber 836 is shown that has a damage 840 that causes damage. Embodiments of damage can include, but are not limited to, cracking of the core fiber (over-stretching, for example, during cable pull or despoil) or over- small-radius bending of the core fiber (over-stretching or over-compression). In some cases, over-bending the core fiber (i.e., bending beyond the core fiber bend radius) can also cause micro-cracks in the core fiber, leading to permanent damage, which can cause the reflected wavelength peaks to overlap, which degrades the ability of the logic to determine the shape of the core fiber.

[0113] As shown, the damage 840 is present within the cross-sectional area 8202 at a location proximal to the reflective gratings 8102-810 N The damage 840 can alter the propagation of the incident light 155 (causing altered propagation of the incident light 156) that propagates past the damage 840 or prevent light from passing to a location distal to the damage 840 (i.e., due to a complete break or rupture).

[0114] As a result, the console 110 can receive reflected light signals 8421-842 N where one or more of the reflected light signals 8422-842 N have an unexpected spectral width due to the altered incident light 156 and / or are unable to be received from one or more of the reflective gratings 8102-810 N due to the reflective gratings being unable to reflect the altered incident light 156. In embodiments where the incident light is prevented from propagating past the damage 840, reflected light signals will only be received from the reflective gratings proximal to the damage 840 (e.g., the reflective grating 8101). Due to the damage 840, for at least a portion of the single-core optical fiber 836 consisting of the cross-sectional areas 8202-820 N the logic of the console 110 is unable to determine the physical state of the single-core optical fiber 836 (or the stylet 800).

[0115] When the console 110 receives the reflected light signal 8421 (and when one or more of the reflected light signals 8422-842 N , in the case of the altered incident light 156 propagating past the damage 840), the optical receiver 184 processes the received reflected light signal and provides it to the reflected data classification logic 190, which further processes the received reflected light signal, as discussed above. The core fiber health detection logic 191 can then analyze the received reflected light signal for an unexpected spectral width (each reflective grating is configured to reflect a particular spectral width of incident light) or for one or more expected spectral widths not being received. Thus, when one or more of the reflected light signals 8422-842 None or more of the reflected light signals include an unexpected spectral width (i.e., do not match the assigned spectral width for each reflective grating 8102-810 N The core fiber health detection logic 191 determines that a break in the core fiber 837 has occurred.

[0116] Further, in some embodiments, the particular spectral width of each received reflected light signal can be analyzed to determine a location of a break (or kink) along the core fiber 837. Specifically, the core fiber health detection logic 191 can further analyze each received light signal to identify: (i) a distal-most reflective grating from which a normal, unbroken light signal is received; and (ii) a proximal-most reflective grating from which a broken (e.g., degraded) light signal is received. Such identification of reflective gratings leads to identification of a location of a kink or break. Thus, by determining that the distal-most reflective grating from which a reflected light signal having an expected spectral width is received is reflective grating 8101 and the proximal-most reflective grating from which a reflected light signal having an unexpected spectral width is received is reflective grating 8102, the core fiber health detection logic 191 identifies a break location 840 (i.e., between reflective gratings 8101 and 8102). In embodiments that prevent the propagation of incident light 155 beyond the break 840, the location of the break 840 is determined based on the lack of a reflected light signal received from any one of 8102-810 N

[0117] In some embodiments, the core fiber health detection logic 191 can be configured to generate a warning indicating that the optical fiber 836 has been broken, and optionally identify a location of the break. The warning can be provided or presented by the console 110 or transmitted to an alternative electronic device (e.g., a speaker or display that is not integrated into the console 110, a network device such as a mobile device, etc.). For example, the warning can be an audio / visual indication that a break has occurred. In some embodiments, the warning can be generated by a separate logic module such as a warning generation logic (not shown).

[0118] ​In some embodiments, the core fiber health detection logic 191 can also be configured to analyze each received optical signal to identify a particular strain detected by the reflective grating. The identified strain can be compared to previously identified strains corresponding to positions or shapes of the core fiber 137 that have a high likelihood of resulting in damage to the core fiber 137. Information relating to the previously identified strains can be stored as part of the reflection data 192. In some embodiments, the core fiber health detection logic 191 can operate in combination with the shape sensing logic 192 for identifying a shape of the core fiber 137 (e.g., the core fiber health detection logic 191 can compare a shape of the core fiber 137 to stored shapes that are known to have a high likelihood of causing damage to the core fiber 137). Thus, the core fiber health detection logic 191 can analyze the received optical signals to determine whether a current shape of the core fiber 137 (or a stylet or catheter in which the core fiber 137 is disposed or otherwise attached) is within a threshold percentage of matching a shape that is known to have a high likelihood of causing damage. More generally, the core fiber health detection logic 191 can analyze the received optical signals to determine whether a strain currently experienced by the core fiber 137 (or a stylet or catheter in which the core fiber 137 is disposed or otherwise attached) is within a threshold percentage of matching a strain that is known to have a high likelihood of causing damage. When the shape or strain of the core fiber 137 resembles a shape or strain that is known to have a high likelihood of causing damage, the core fiber health detection logic 191 can cause a warning to be generated. In some embodiments, a “resembling shape or strain” can refer to an identified shape or strain being within a threshold percentage of matching a shape or strain that is known to have a high likelihood of causing damage.

[0119] In embodiments, the core fiber health detection logic 191 can also extrapolate the reflection data of the core fiber 137 to predict a future shape (and corresponding strain) of the core fiber 137. When the extrapolated shape or strain of the core fiber 137 resembles a shape or strain that is known to have a high likelihood of causing damage, the core fiber health detection logic 191 can cause a warning to be generated. In some embodiments, a “resembling shape or strain” can refer to an extrapolated shape or strain being within a threshold percentage of matching a shape or strain that is known to have a high likelihood of causing damage. Further, the core fiber health detection logic 191 can perform similar analysis on the received optical signals to determine whether a stylet and / or catheter in which the core fiber is disposed (or otherwise attached) is currently in a shape or experiencing a strain that is known to have a high likelihood of causing damage. Similarly, the core fiber health detection logic 191 can perform similar analysis on the received optical signals to determine whether a stylet and / or catheter in which the core fiber is disposed (or otherwise attached) is currently prolapsed.

[0120] With reference toFigure 1A According to embodiments, a portion of a multi-core optical fiber is shown including a kink or partial damage 900 within a Figure 2 Figure 2 According to embodiments, a portion of a multi-core optical fiber is shown including a kink or partial damage 900 within a Figure 2 According to embodiments, a portion of a multi-core optical fiber is shown including a kink or partial damage 900 within a 11 -210 NM According to embodiments, a portion of a multi-core optical fiber is shown including a kink or partial damage 900 within a N N 11 -210 14 ...210 N1 -210 N4 .

[0121] However, unlike Figure 9A , Figure 9A a portion of a multi-core optical fiber is shown including a damage 900 that affects a core fiber 1372 within a cross-sectional region 2202 between a reflective grating 210 12 and a reflective grating 210 22 The damage 900 can be the result of one or more of a variety of factors, including a kink and / or excessive strain (compression or stretching) placed on the core fiber 1372. Additionally or alternatively, a blunt physical force caused by the core fiber 1372 can result in the damage 900. Detection of the damage 900 is beneficial so that a warning can be generated notifying a user of such a condition. For example, a physician who improperly trims a catheter without pulling back the catheter containing the optical fiber would be immediately notified by the generation of a warning that their practice is affecting system functionality.

[0122] As shown, the incident light 155 propagates along the length of each core fiber 1371-1374 so that the reflective gratings disposed thereon can reflect the optical signal back to the console 110. However, in some cases, the damage 900 can affect the incident light propagating along the length of the core fiber 1372 so that a changed incident light 156 propagates along the length of the core fiber 1372 distally of a point along the core fiber 1372 at which the damage 900 occurs ("damage point 900"). The changed incident light 156 can be degraded or changed in any way that can affect the ability of the reflective gratings 210 22 -210 N2 to reflect the optical signal according to the strain applied on the respective cross-sectional region. In some embodiments, the incident light 155 is not able to propagate completely past the damage 900.

[0123] ​More specifically, the damage 900 causes a change in the incident light 155 propagating along the core fiber 1372, resulting in a changed incident light 156 propagating distal to the damage 900, where the changed incident light 156 can be a portion of the incident light 155. The reflected light signal 902 is reflected by one or more reflective gratings (i.e., reflective gratings 210 22 -210 N2 ) distal to the damage 900, where the reflected light signal 902 includes a reflected light signal having an unexpected spectral width. In some cases, the reflected light signal 902 includes a reflected light signal from less than all of the reflective gratings 210 22 -210 N2 (i.e., one or more of the reflective gratings 210 22 -210 N2 do not reflect a light signal). In some embodiments, the damage 900 can be a complete break or fracture of the core fiber 1372 such that no portion of the incident light 155 can propagate past the damage 900. In such cases, the reflective gratings 210 22 -210 N2 will not reflect the reflected light signal 902.

[0124] Upon receipt of the reflected light signals 1521-1524 and 902 at the console 110, the optical receiver 184 processes the received reflected light signals and provides them to the reflected data classification logic 190, which further processes the received reflected light signals as discussed above. The core fiber health detection logic 191 can then analyze the received reflected light signals corresponding to each core fiber 1371-1374. In one embodiment, each core fiber 1371-1374 is assigned a unique identifier (ID) associated with each reflected light signal. Thereby, the association of a reflected light signal with a particular core fiber 1371-1374 is maintained via the unique ID of each core fiber 1371-1374.

[0125] Specifically, the detection of damage to the core fibers 1371-1374 is performed by analyzing the unexpected spectral width of the received reflected light signals 1521-1524 and 902 (each reflective grating is configured to reflect incident light at a particular spectral width) or the lack of receiving one or more expected spectral widths. Thus, where the reflected light signal 902 includes an unexpected spectral width (i.e., does not match those assigned to the reflective gratings 210 i -210 22 -210 N2 ), the core fiber health detection logic 191 determines that a damage to the core fiber 1372 has occurred.

[0126] Further, in some embodiments, a particular spectral width of each received reflected light signal can be analyzed to determine a location of a break (or kink) along the core fiber 1372. As the core fiber health detection logic 191 (or more generally, the reflected data classification logic 190) determines that an unexpected spectral width is received from the core fiber 1372 within the received light signal 902, the core fiber health detection logic 191 can further analyze each of the received light signals 1522 and 902 to identify: (i) a distal-most reflection grating from which a normal, unimpaired light signal is received; and (ii) a proximal-most reflection grating from which an impaired (e.g., degraded) light signal is received. Such identification of the reflection gratings leads to identification of a location of a kink or break. Thus, by determining that the distal-most reflection grating from which a reflected light signal having an expected spectral width is received is reflection grating 210 12 and the proximal-most reflection grating from which a reflected light signal having an unexpected spectral width is received is reflection grating 210 22 , the core fiber health detection logic 191 identifies a break location 900 (i.e., between reflection gratings 210 12 and 210 22 ).

[0127] While a break can reduce or alter operability of one or more core fibers, an optical fiber including a redundant core fiber can remain fully or partially functional beyond the break point. As shown in FIG. 21, which shows that the core fiber 1372 is broken within the cross-sectional region 2202, while core fibers 1371 and 1373-1374 are unbroken; thus, some functionality of the multi-core optical fiber 136 can be maintained through reflected signals received from core fibers 1371 and 1373-1374. Figure 9A

[0128] ​For example, in some embodiments, the stylet can be configured to perform several measurements and / or take several readings during advancement through the catheter lumen, such that these measurements and readings are provided to the logic of the console (e.g., console 110) for processing. For example, the multi-core optical fiber can be integrated within the stylet with one or more pulse oximetry sensors and / or one or more electrodes for intravascular electrocardiogram (ECG) monitoring. Such a stylet provides the console 110 with measurements and readings for analysis that determine the physical state of the stylet (e.g., shape), whether the distal tip of the stylet has entered the azygos vein, the amount of deflection of the distal tip of the stylet, the oxygen level in the patient's blood, and location tracking of the distal tip of the stylet via ECG monitoring. In the event that one or more core fibers of the multi-core optical fiber are damaged, the stylet is still operable to obtain measurements and / or readings related to one or more of the above-mentioned functions. For example, in the event that one or more core fibers are damaged, the stylet is still functional to provide information related to whether the distal tip of the stylet has entered the azygos vein, the amount of deflection of the distal tip of the stylet, the oxygen level in the patient's blood, and location tracking of the distal tip of the stylet via ECG monitoring.

[0129] One or more embodiments of the present application can include an implementation subject configured to perform any combination of the following functions: optical fiber deflection sensing / monitoring, optical fiber shape sensing, optical fiber oximeter monitoring, distal tip placement confirmation, distal tip location / tracking, azygos vein detection, impedance / conductance sensing, intravascular ECG monitoring, and / or optical fiber vein / artery cannulation detection. As discussed above, such an implementation subject is configured to maintain the ability to perform one or more of these functions when one or more of the core fibers of the multi-core optical fiber integrated into the implementation subject are so damaged or kinked and non-functional after the kink or damage point.

[0130] Additionally, the multi-core optical fiber 136 can include a greater number of core fibers than shown in the drawings included herein, which can provide sufficient redundancy to maintain shape sensing functionality past the damage point. To maintain the ability to perform shape sensing past the damage point, there are more core fibers that are operable (i.e., those that are able to receive incident light and reflect the light signal to the console 110, which do not have a degradation that prevents the shape sensing logic 194 from determining the physical state of the stylet / catheter with a level of confidence). As one example embodiment, a multi-core optical fiber having seven or more core fibers will include sufficient redundancy to maintain shape sensing functionality past the damage point when one of the seven core fibers is non-functional past the damage point.

[0131] However, in some embodiments, the optical fiber can not include sufficient redundancy to maintain shape sensing capability due to damage. For example, referring to the multi-core optical fiber 136 including four peripheral core fibers and one central core fiber, if the central core fiber is damaged, the stylet can no longer be able to perform shape sensing. In this case, the stylet can still be able to provide information related to whether the distal tip of the stylet has entered the azygos vein, the amount of deflection of the distal tip of the stylet, the oxygen level in the patient's blood, and location tracking of the distal tip of the stylet via ECG monitoring. However, the stylet can no longer be able to provide shape sensing information. Figure 9BDamage to the outer core will prevent the maintenance of shape sensing capabilities. However, damage to only the central core while the four outer cores function normally will provide redundant shape sensing capabilities.

[0132] refer to Figure 1A According to some implementation schemes, it is shown that includes Figure 9A An exemplary embodiment of the structure of a completely damaged portion of a multi-core optical fiber within the core needle 120. (This is in relation to the above regarding...) Figure 9A In the same manner, the core fiber health detection logic 191 analyzes reflected light signals 9061-9064 for unexpected spectral widths (or lack thereof).

[0133] Therefore, the reflected light signals 1521-1524 and 9061-9064 include unexpected spectral widths (i.e., mismatched assignments to each reflected grating 210). 11 -210 14 ...210 N1 -210 N4 Those), the fiber health detection logic 191 determines that damage has occurred affecting each core fiber 1371-1374 904.

[0134] Similarly, as mentioned above... Figure 9A As discussed, the specific spectral width of each received reflected light signal can be analyzed to determine the location of damage (or kinking) along the core fibers 1371-1374. The core fiber health detection logic 191 can further analyze each of the reflected light signals 1521-1524 and 9061-9064 to identify: (i) the farthest reflecting grating from which it receives a normal, undamaged light signal; and (ii) the nearest reflecting grating from which it receives a damaged (e.g., degraded) light signal. Therefore, by determining that the farthest reflecting grating from which it receives a reflected light signal with the expected spectral width is reflecting grating 210... 11 210 12 210 13 and 210 14 (Refer to core fibers 1371-1374 respectively) and the nearest-side reflection grating from which the reflected light signal with an unexpected spectral width is reflection grating 210. 21 210 22 210 23 and 210 24 (Refer to core fiber 1371-1374 respectively), core fiber health detection logic 191 identifies the location of damage 904.

[0135] While damage may reduce or alter the operability of one or more core fibers, optical fibers that include redundant core fibers can retain full or partial functionality outside the point of damage. For example... ​As shown, it is shown that core fiber 1372 is damaged within cross-sectional region 2202, while core fibers 1371 and 1373-1374 are not damaged; thus, some functionality of multi-core fiber 136 can be maintained by reflected signals received from core fibers 1371 and 1373-1374.

[0136] It should be appreciated that in the case where damage 904 is a complete break or fracture such that no incident light 155 propagates beyond damage 904, reflected light signals 9061-9064 are not present.

[0137] While certain specific embodiments have been disclosed herein, and while the specific embodiments have been disclosed in some detail to provide a thorough understanding thereof, it will be apparent that alternatives and / or modifications of the specific embodiments can occur to those of ordinary skill in the art. It is intended that the scope of the concepts provided herein encompass all such alternatives and / or modifications.

Claims

1. A medical device system for detecting damage to fiber optic technology in medical devices, characterized in that, The system includes: The medical device 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 the longitudinal length of the respective core fiber, and each of the plurality of sensors being configured to: (i) reflect optical signals of different spectral widths based on received incident light; and (ii) modify the characteristics of the reflected optical signals to determine the physical state of the optical fiber; and A console includes one or more processors and a non-transitory computer-readable medium having logic stored thereon, which, when executed by the one or more processors, causes operations including: Provide the optical fiber with a broadband incident optical signal; Receive optical signals of different spectral widths of the broadband incident light reflected by one or more of the plurality of sensors; Process the reflected light signal associated with the one or more core fibers to identify at least one unexpected spectral width or to identify a lack of an expected spectral width; Based on identifying at least one unexpected spectral width, the absence of an expected spectral width, or a decrease in the intensity of reflected light signals, it is determined that one or more of the core fibers have been damaged; Identify the first core fiber affected by the damage; and Determine the location of the damage along the first core fiber.

2. The system according to claim 1, characterized in that, Unintended spectral width is a spectral width that is not configured to be used by any of the multiple sensors in the core fiber.

3. The system according to claim 1, characterized in that, The optical fiber is a single-core optical fiber.

4. The system according to claim 1, characterized in that, The optical fiber is a multi-core optical fiber comprising multiple core fibers.

5. The system according to claim 4, characterized in that, The damage affects a first subset of the plurality of core fibers.

6. The system according to claim 5, characterized in that, The second subset of the plurality of core fibers is unaffected by the damage, so that the multi-core fiber maintains at least some of its functionality based on the second subset of the plurality of core fibers.

7. The system according to claim 6, characterized in that, The at least some of the functions include one or more of the following: fluctuation sensing of the distal tip of the medical device, shape sensing of the multi-core optical fiber, blood oxygen monitoring, distal tip confirmation, distal tip position detection, detection of the distal tip of the medical device entering the azygos vein, impedance or conduction sensing, intravascular ECG monitoring or vascular cannulation detection.

8. The system according to claim 7, characterized in that, When executed by the one or more processors, the logic causes further operations including performing at least a portion of the functions of the multi-core optical fiber, regardless of information provided by the first core fiber, which has reflected an optical signal having a first unintended spectral width.

9. The system according to claim 6, characterized in that, The second subset of the plurality of core fibers includes redundant core fibers, thereby maintaining the shape sensing function of the multi-core optical fiber.

10. The system according to claim 1, characterized in that, The medical device is one of a guidewire, a guide wire, a core needle, a core needle inside a needle, a needle having a sheath embedded in the needle, or a catheter having one or more walls embedded in the catheter.

11. The system according to claim 1, characterized in that, The first core fiber is determined based on a unique identifier assigned to the first core fiber and the association of the unique identifier with each optical signal reflected by the first core fiber.

12. The system according to claim 1, characterized in that, Determining the location of the damage includes identifying: (i) the farthest sensor of the first core fiber from which a first optical signal with a expected spectral width is received; (ii) receiving a second optical signal with a first unexpected spectral width from it, receiving a second optical signal with reduced intensity from it, or not receiving a corresponding expected spectral width from the nearest-side sensor.

13. The system according to claim 1, characterized in that, Each of the plurality of sensors is a reflective grating, wherein each reflective grating alters its reflected light signal by applying a wavelength offset, the wavelength offset depending on the strain experienced by the reflective grating.

14. The system according to claim 1, characterized in that, When executed by the one or more processors, the logic causes further operations including generating a warning indicating that the optical fiber has been damaged.

15. The system according to claim 14, characterized in that, The warning includes an indication of the location of the damage.

16. A non-transitory computer-readable medium having logic stored thereon, characterized in that, When executed by one or more processors, the logic causes operations including the following: Provide a broadband incident optical signal to an optical fiber included in 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 gratings distributed along the longitudinal length of the respective core fiber, and each of the plurality of reflective gratings is configured to: (i) reflect optical signals of different spectral widths based on the received incident light; (ii) altering the characteristics of the reflected light signal to determine the physical state of the optical fiber; Receive optical signals of different spectral widths of the broadband incident light reflected by one or more of the plurality of reflection gratings; Process the reflected light signal associated with the one or more core fibers to identify at least one unexpected spectral width or to identify a lack of an expected spectral width; Based on identifying at least one unexpected spectral width, the absence of an expected spectral width, or a decrease in the intensity of reflected light signals, it is determined that one or more of the core fibers have been damaged; Identify the first core fiber affected by the damage; and Determine the location of the damage along the first core fiber.

17. The non-transitory computer-readable medium according to claim 16, characterized in that, Unintended spectral width is the spectral width that is not configured to be used by any of the plurality of reflective gratings of the core fiber.

18. The non-transitory computer-readable medium according to claim 16, characterized in that, The optical fiber is a single-core optical fiber.

19. The non-transitory computer-readable medium according to claim 16, characterized in that, The optical fiber is a multi-core optical fiber comprising multiple core fibers.

20. The non-transitory computer-readable medium according to claim 19, characterized in that, The damage affects a first subset of the plurality of core fibers.

21. The non-transitory computer-readable medium according to claim 20, characterized in that, The second subset of the plurality of core fibers is unaffected by the damage, so that the multi-core fiber maintains at least some of its functionality based on the second subset of the plurality of core fibers.

22. The non-transitory computer-readable medium according to claim 21, characterized in that, The at least some of the functions include one or more of the following: fluctuation sensing of the distal tip of the medical device, shape sensing of the multi-core optical fiber, blood oxygen monitoring, distal tip confirmation, distal tip position detection, detection of the distal tip of the medical device entering the azygos vein, impedance or conduction sensing, intravascular ECG monitoring or vascular cannulation detection.

23. The non-transitory computer-readable medium according to claim 22, characterized in that, When executed by the one or more processors, the logic causes further operations including performing at least a portion of the functions of the multi-core optical fiber, regardless of information provided by the first core fiber, which has reflected an optical signal having a first unintended spectral width.

24. The non-transitory computer-readable medium according to claim 21, characterized in that, The second subset of the plurality of core fibers includes redundant core fibers, thereby maintaining the shape sensing function of the multi-core optical fiber.

25. The non-transitory computer-readable medium according to claim 16, characterized in that, The medical device is one of a guidewire, a guide wire, a core needle, a core needle inside a needle, a needle having a sheath embedded in the needle, or a catheter having one or more walls embedded in the catheter.

26. The non-transitory computer-readable medium according to claim 16, characterized in that, The first core fiber is determined based on a unique identifier assigned to the first core fiber and the association of the unique identifier with each optical signal reflected by the first core fiber.

27. The non-transitory computer-readable medium according to claim 16, characterized in that, Determining the location of the damage includes identifying: (i) the farthest side reflective grating of the first core fiber from which a first optical signal with a expected spectral width is received; and (ii) the nearest side reflective grating from which a second optical signal with a first unexpected spectral width is received, a second optical signal with reduced intensity is received, or the corresponding expected spectral width is not received.

28. The non-transitory computer-readable medium according to claim 16, characterized in that, Each reflective grating alters its reflected light signal by applying a wavelength offset, the wavelength offset depending on the strain experienced by the reflective grating.

29. The non-transitory computer-readable medium according to claim 16, characterized in that, When executed by the one or more processors, the logic causes further operations including generating a warning indicating that the optical fiber has been damaged.

30. The non-transitory computer-readable medium according to claim 29, characterized in that, The warning includes an indication of the location of the damage.

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