Systems and methods for optical shape sensing and electrical signal conduction

Abstract

A medical device that functions as a stylet is described. The medical device can include an insulating layer (or jacket) that encapsulates both a multicore optical fiber and a conductive medium. The optical fiber can include a cladding and a plurality of core fibers spatially arranged within the cladding. Each of the core fibers can include a plurality of sensors distributed along a longitudinal length of the corresponding core fiber, and each of the sensors can be configured to: (i) reflect light signals having different spectral widths based on received incident light, and (ii) alter a characteristic of the reflected light signals for determining a physical state of the multicore optical fiber. The conductive medium can provide a path for electrical signals detected at a distal portion of the conductive medium. The conductive medium can be concentric with the cladding, but can be separate from and adjusted to the cladding.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 62 / 984,552, filed March 3, 2020, the entire contents of which are incorporated herein by reference. Background Technology

[0003] In the past, certain intravascular guidance methods for medical devices such as guidewires and catheters have used fluorescence microscopy to track the tip of the medical device and determine whether the tip is properly positioned within its target anatomy. However, such fluorescence microscopy methods expose patients and their attending physicians to harmful X-ray radiation. Furthermore, in some cases, patients are exposed to potentially harmful contrast agents required for fluorescence microscopy.

[0004] Recently, electromagnetic tracking systems involving multimodal needles have been used. Typically, electromagnetic tracking systems are characterized by three components: a field generator, a sensor unit, and a control unit. The field generator uses several coils to generate a position-changing magnetic field, which is used to establish a coordinate space. For example, a sensor unit, such as one attached near the distal end (tip) of the needle, includes small coils in which current is induced via the magnetic field. Based on the electrical properties of each coil, the position and orientation of the medical device in the coordinate space can be determined. The control unit controls the field generator and captures data from the sensor unit.

[0005] While electromagnetic tracking systems avoid line-of-sight dependence when tracking needle tips and eliminate radiation exposure and potentially harmful contrast agents associated with fluorescein microscopy, they are susceptible to interference. More specifically, because electromagnetic tracking systems rely on the measurement of a magnetic field generated by a field generator, they are subject to electromagnetic interference, which can be caused by the presence of many different types of consumer electronics, such as cellular phones. Additionally, electromagnetic tracking systems are prone to signal loss, depend on external sensors, and are limited to a finite depth range.

[0006] This paper discloses an optical fiber shape sensing system and method that does not have the drawbacks associated with the electromagnetic tracking system described above and is able to provide confirmation of tip placement or information as electrical signal transmission / interpretation in its current form. Summary of the Invention

[0007] In brief, the embodiments disclosed herein relate to a multimodal mandrel characterized by a multi-core optical fiber and a conductive medium, which operate together to track the placement of a catheter or other medical device within a patient. When functioning as a medical device, the mandrel is configured to return information for identifying the physical state (e.g., shape, length, shape, form, and / or orientation) of: (i) a portion of the mandrel (e.g., a tip, segment, etc.) or a portion of a catheter comprising at least a portion of the mandrel (e.g., a tip, segment, etc.), or (ii) the entire mandrel or a substantial portion of a catheter within the patient (hereinafter described as "physical state of the mandrel" or "physical state of the catheter"). According to one embodiment of this disclosure, the returned information can be obtained from reflected optical signals of different spectral widths, wherein each reflected optical signal corresponds to a portion of broadband incident light propagating along the core of a multi-core optical fiber (hereinafter referred to as "core fiber"), which is reflected back on the core fiber by a specific sensor located on the core fiber. An illustrative example of the returned information could involve changes in the signal characteristics of the reflected light signal returned from the sensor, where the wavelength shift is related to (mechanical) strain on the core fiber.

[0008] In some embodiments, the core includes a multi-core optical fiber, wherein each core utilizes multiple sensors, and each sensor is configured to reflect a different spectral range of incident light (e.g., a different range of optical frequencies). Based on the type and degree of strain applied to each core, the sensor associated with the core can alter (displace) the wavelength of the reflected light to convey the type and degree of strain on the core at those locations on the core occupied by the sensor. The sensors are spatially distributed at various locations on the core between the proximal and distal ends of the core, allowing shape sensing of the core to be performed based on analysis of wavelength displacement. Herein, shape sensing functionality is paired with the ability to simultaneously transmit electrical signals through the same component (the core) via a conductive medium included as a part of the core.

[0009] More specifically, in some embodiments, each core fiber in a multi-core optical fiber is configured with a sensor array spatially distributed along a predetermined length of the core fiber to substantially sense external strain in the regions of the core fiber occupied by the sensors. Given that each sensor positioned along the same core fiber is configured to reflect light with a different specific spectral width, the sensor array enables distributed measurements throughout the entire predetermined length of the multi-core optical fiber. These distributed measurements may include wavelength shifts associated with the strain experienced by the sensors.

[0010] According to one embodiment of this disclosure, each sensor may act as a reflective grating such as a fiber Bragg grating (FBG), i.e., an intrinsic sensor corresponding to a permanent periodic refractive index change inscribed into a core fiber. In other words, for a specific spectral width (e.g., a specific wavelength or a specific wavelength range), the sensor acts as a reflector. As a result, as broadband incident light is supplied by an optical source and propagates through the specific core fiber, upon reaching a first sensor in the sensor distributed array of the core fiber, the light with a defined spectral width associated with the first sensor is reflected back to an optical receiver within a console, which includes a display and an optical source. The remaining spectral width of the incident light continues to propagate through the core fiber to the distal end of the core needle. The remaining spectrum of the incident light may encounter other sensors in the sensor distributed array, each of which, as described above, is manufactured to reflect light with a different specific spectral width to provide distributed measurements.

[0011] During operation, multiple light reflections (also referred to as "reflected light signals") return to the console from each of the multiple core fibers in the multimode fiber. Each reflected light signal can be uniquely associated with a different spectral width. The information associated with the reflected light signals can be used to determine a three-dimensional representation of the physical state of the core needle within the patient's body. In this paper, the core fibers are spatially separated from the cladding of the multimode fiber, and each core fiber is configured to separately return light with different spectral widths (e.g., specific wavelengths or wavelength ranges) reflected from a distributed sensor array fabricated in each of the core fibers. The shift in the detected wavelength of the reflected light returned by the central core fiber (acting as a reference) compared to that of the surrounding peripheral core fibers can be used to determine the physical state of the core needle.

[0012] More specifically, during vascular system insertion, clinicians can rely on a console to visualize the current physical state (e.g., shape, orientation, etc.) of the catheter guided by the core, to avoid potential path deviations that may occur due to changes in catheter orientation. Because the outer core fibers reside at different spatial locations within the cladding of the multimode fiber, changes in core orientation (e.g., angular orientation changes such as bending) impose different types (e.g., compression or tension) and degrees of strain on each of the outer core fibers and the central core fiber. Different types and / or degrees of strain may cause different wavelength shifts in the core fiber sensors, which can be measured to extrapolate the physical state of the core (and catheter).

[0013] As an illustrative example, in the vascular access region, a multimodal cored needle will allow additional information transmitted via electrical signals (e.g., an electrocardiogram "ECG") to be transmitted via a conductive medium and shape-sensing information to be transmitted from the cored needle via optical fiber. In the case of a central access, this will allow ECG verification techniques to be used in conjunction with reliable interpretation of the shape and position of the cored needle (and the optical fiber and / or conductive medium). As described in detail below, a multimodal cored needle with multi-core optical fiber and conductive medium can be constructed according to any of a number of configurations, such as braided configurations, parallel configurations, flexible circuit configurations, conductive tube configurations, or any other configuration selected by taking into account desired cored needle stiffness and properties.

[0014] These and other features of the embodiments of the invention will become more apparent from the following description and appended claims, or may be learned by practicing the embodiments of the invention as described below. Attached Figure Description

[0015] A more specific description of the present disclosure will be presented with reference to specific embodiments illustrated in the accompanying drawings. It should be understood that these drawings depict only exemplary embodiments of the invention and are therefore not intended to limit the scope of the invention. Exemplary embodiments of the invention will be described and explained by way of additional features and details, in which:

[0016] Figure 1 This is an illustrative embodiment of a medical device monitoring system;

[0017] Figure 2 yes Figure 1 An exemplary embodiment of the core assembly;

[0018] Figure 3 It is used to place Figure 1 An example of a catheter core needle;

[0019] Figure 4 yes Figures 1 to 3 An example of inserting a venous catheter into a patient's vascular system;

[0020] Figure 5 Is included Figures 1 to 3 An exemplary embodiment of the structure of a portion of the multi-core optical fiber within the core needle 130;

[0021] Figure 6A yes Figure 1 A first exemplary embodiment of a multimodal core that supports both optical and electrical signaling;

[0022] Figure 6B yes Figure 6AA cross-sectional view of a multimodal core needle;

[0023] Figure 7A yes Figure 1 A second exemplary embodiment of the multimodal core needle;

[0024] Figure 7B yes Figure 7A First cross-sectional view of a multimodal core needle;

[0025] Figure 7C yes Figure 7A A second cross-sectional view of a multimodal core needle;

[0026] Figure 8A yes Figure 1 A third exemplary embodiment of the multimodal core needle;

[0027] Figure 8B yes Figure 8A A cross-sectional view of a multimodal core needle;

[0028] Figure 9A yes Figure 1 A fourth exemplary embodiment of the multimodal core needle;

[0029] Figure 9B yes Figure 9A A cross-sectional view of a multimodal core needle;

[0030] Figure 10A yes Figure 1 A fifth exemplary embodiment of the multimodal core needle;

[0031] Figure 10B yes Figure 10A A cross-sectional view of a first embodiment of a multimode core, wherein a conductive medium partially encapsulates a portion of an optical fiber;

[0032] Figure 10C yes Figure 10B A cross-sectional view of a second embodiment of a multimode core, wherein a conductive medium partially encapsulates a large portion of the optical fiber;

[0033] Figure 10D yes Figure 10A A cross-sectional view of a third embodiment of a multimode core, wherein a significant portion of the optical fiber is encapsulated in a conductive medium;

[0034] Figure 11A yes Figure 1 The sixth exemplary embodiment of the multimodal core needle; and

[0035] Figure 11B yes Figure 11A A cross-sectional view of a multimodal core needle. Detailed Implementation

[0036] Referring now to the accompanying drawings, similar structures will be provided with similar reference numerals. It should be understood that the drawings are illustrative and schematic representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0037] Regarding the terminology used herein, it should be understood that the terminology is for the purpose of describing certain specific embodiments and is not limited to the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different components or operations and do not provide for a sequence or numerical limitation. For example, the components or operations “first,” “second,” and “third” do not necessarily appear in the stated order, and a particular embodiment including such components or operations is not necessarily limited to these three components or operations. Similarly, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly specifies otherwise, the singular forms “a (a, an)” and “the” include the plural reference forms.

[0038] In the following description, the terms “or” and “and / or” as used herein will be interpreted as inclusive or to mean any one or any combination. For example, “A, B, or C” or “A, B, and / or C” means “any one of the following: A; B; C; A and B; A and C; B and C; A, B, and C”. Exceptions to this definition will only occur if the combination of elements, components, functions, steps, or actions is inherently mutually exclusive in some way.

[0039] The term "logic" refers to hardware and / or software configured to perform one or more functions. As hardware, logic can include circuitry with data processing and / or storage capabilities. Examples of such circuitry may include, but are not limited to, processors, programmable gate arrays, microcontrollers, application-specific integrated circuits (ASICs), combinational circuits, etc. Alternatively, or in combination with the aforementioned hardware circuitry, logic can be software in the form of one or more software modules that can be configured to act as their corresponding circuitry. Software modules can include, for example, executable applications, daemon applications, application programming interfaces (APIs), subroutines, functions, programs, routines, source code, or even one or more instructions. Software modules can be stored in any suitable non-transitory storage medium, such as programmable circuitry, semiconductor memory, non-persistent storage devices (such as volatile memory (e.g., any type of random access memory "RAM")), persistent storage devices (such as non-volatile memory (e.g., read-only memory "ROM", powered RAM, flash memory, phase-change memory, etc.)), solid-state drives, hard disk drives, optical disk drives, or portable storage devices.

[0040] For clarity, it should be understood that the term "proximal" refers to a direction relatively closer to the clinician using the device described herein, while the term "distal" refers to a direction relatively farther from the clinician. In this document, for example, the "proximal portion" of the cardiac catheter disclosed herein includes a portion of the cardiac catheter intended to be close to the clinician when used on a patient. Similarly, the "proximal end" of the cardiac catheter includes, for example, the end intended to be close to the clinician when used. The proximal portion of the cardiac catheter may include the proximal end of the cardiac catheter; however, the proximal portion of the cardiac catheter does not necessarily need to include the proximal end of the cardiac catheter.

[0041] Similarly, the “distal portion” of the cardioverter-cushion includes the portion of the cardioverter-cushion intended to be close to or within the patient when used on a patient. Likewise, the “distal end” of the cardioverter-cushion includes the end of the cardioverter-cushion intended to be close to or within the patient when used on a patient. The distal portion of the cardioverter-cushion may include the distal end of the cardioverter-cushion; however, the distal portion of the cardioverter-cushion does not necessarily include the distal end of the cardioverter-cushion. Furthermore, the terms “including” and “having” as used herein (including the claims) shall have the same meaning as the term “comprising”.

[0042] Embodiments of this disclosure generally relate to a multimodal mandrel that assists in the placement of a medical device inserted into a patient. An example of this medical device is a catheter assembly inserted into a patient's vein or other blood vessel to inject or aspirate fluid through one or more lumens defined by the catheter for the patient. In one embodiment, the system utilizes a multi-core optical fiber with a reflective grating to confirm information about the fiber during and / or after insertion into the patient for the purpose of presenting the shape and orientation of the mandrel.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0044] In one embodiment, the reflection grating may include fiber Bragg gratings (“FBGs”) distributed along the core fibers disposed in / on the mandrel (or another similar probe). An output optical signal generated by a light source is incident along the core fibers onto each of the FBGs, wherein each grating reflects light of a defined spectral width to generate a return optical signal to the console. According to one embodiment of this disclosure, the wavelength shift of the reflected optical signal returned by each of the core fibers may be aggregated based on the FBGs associated with the same cross-sectional area (or specific spectral width) of the mandrel, and the console processor may execute shape-sensing analysis logic to perform analyses associated with the wavelength shifts (e.g., degree analysis, comparisons between wavelength shifts between peripheral core fibers and the central core fiber, or between peripheral core fibers, etc.) to identify the physical state of the mandrel. Data is transmitted to the user of the console to identify (and render) its position within the body, the two-dimensional (2-D) and three-dimensional (3-D) shape of the mandrel along its length, form, and shape (e.g., bending, twisting), and orientation (including misalignment or medical device kinking), etc. The console presents this information to the user in real time to assist in guiding and placing medical devices (e.g., catheters) along with pointers according to the patient's needs. Additionally, measurements can be taken via the console (e.g., ECG signaling via a conductive medium coexisting with a multi-core fiber) to ensure proper deployment within the patient's body. Further details regarding these and other embodiments are given below.

[0045] Note that although the following discussion emphasizes the use of a pedicle screw for catheter placement in a patient, the pedicle screw described herein can be used to place various medical devices, particularly other elongated medical devices, at various locations within a patient. Thus, the principles of this disclosure should not be considered limited to what is explicitly described herein. Examples of catheter assemblies and medical devices from which this disclosure may benefit include peripherally inserted central catheters (“PICC”), central venous catheters (“CVC”), urinary catheters, midline catheters, peripheral catheters, etc.

[0046] Given the above, the multi-core optical fiber paired with the conductive medium used for electrical signal monitoring thus has multiple modes. The first mode constitutes an optical mode with shape-sensing functionality to determine the physical state of the needle. The physical state of the needle provides information to assist clinicians in guiding the catheter assembly to the desired location within the vascular system. The second mode constitutes a tip positioning / navigation system (“TLS”) mode, in which the conductive medium-loaded needle is advanced to detect and avoid any tip misalignment during this advancement. Finally, the third mode constitutes an ECG mode, in which ECG signal-based catheter tip guidance enables the tracking of the needle / catheter tip and its guidance relative to the node of the patient's heart that generated the ECG signal to the desired location.

[0047] As an alternative embodiment, the conductive medium may be configured with channels or grooves in which multi-core optical fibers may reside, or one or more core optical fibers separate from the multi-core optical fibers may reside in the channels or grooves. Furthermore, instead of the conductive medium located at the distal end of the mandrel, it is conceivable that the conductive medium extends from the control console and terminates slightly distally from the mandrel shank, contacting the brine fluid path, while the multi-core optical fibers extend the length of the conduit. Therefore, another conductive medium (e.g., brine or another conductive fluid via Luer connector 340) can provide the conductive path.

[0048] refer to Figure 1 An illustrative embodiment of a medical device monitoring system 100 is shown. As illustrated, system 100 typically includes a console 110 and a handheld medical device 120 (hereinafter referred to as a "mind assembly") communicatively coupled to console 110. In this embodiment, the mind assembly 120 includes an elongated probe (e.g., a mind) 130 at its distal end 122 and a console connector 132 at its proximal end 124. The console connector 132 enables the mind assembly 120 to be operatively connected to console 110 via an interconnect 140, which includes one or more optical fibers 142 (hereinafter referred to as "optical fibers") and a conductive medium 144 terminated by a single optical fiber / electrical connector 146 (or terminated by a dual connector). Hereinafter, connector 146 is configured to engage (mate) with console connector 132 to allow light to propagate between console 110 and mind assembly 120 and electrical signals to propagate from mind 130 to console 110.

[0049] Although exemplary embodiments of console 110 include processor 160, memory 165, display 170, and optical logic 180, it should be understood that console 110 may take many forms and may include additional components (e.g., power supply, ports, interfaces, etc.) not specific to any aspect of this disclosure. An illustrative example of console 110 is shown in U.S. Publication No. 2019 / 0237902, the entire contents of which are incorporated herein by reference. Processor 160 includes access to memory 165 (e.g., non-volatile memory) to control the functionality of console 110 during operation. As shown, display 165 may be a liquid crystal diode (LCD) display integrated into console 110 and used as a user interface to display information to clinicians, particularly during catheter placement procedures (e.g., cardiac catheterization). In another embodiment, display 165 may be separate from console 110. Although not shown, the user interface is configured to provide user control of console 110.

[0050] For both embodiments, the content depicted by display 165 can change depending on the mode in which the core 130 is configured to operate: optical, TLS, ECG, or other modes. In TLS mode, the content rendered by display 165 can constitute a two-dimensional (2-D) or three-dimensional (3-D) representation of the physical state (e.g., length, shape, form, and / or orientation) of the core 130 calculated based on the characteristics of the reflected light signal 150 returned to console 110. The reflected light signal 150 constitutes light of a specific spectral width of broadband incident light 155 reflected back to console 110. According to one embodiment of this disclosure, as described below, the reflected light signal 150 can be associated with various discrete portions (e.g., specific spectral widths) of the broadband incident light 155 transmitted from and emitted by optical logic 180.

[0051] According to one embodiment of this disclosure, an activation control 126 included on the needle assembly 120 can be used to set the needle 130 to a desired operating mode, and a clinician can selectively change the operability of the display 165 to assist in medical device placement. For example, based on the mode of the needle 130, the display 165 of the console 110 can be used for guidance based on an optical mode or a TLS mode during catheter advancement through the vascular system to determine the physical state of the needle 130 (e.g., length, form, shape, orientation, etc.). In one embodiment, information from multiple modes (such as, for example, optical, TLS, or ECG) can be displayed simultaneously (e.g., at least partially overlapping in time). In one embodiment, the display 165 is a liquid crystal diode (LCD) device.

[0052] Still referencing Figure 1Optical logic 180 is configured to support the operability of the core assembly 120 and enable information to be returned to console 110. This information can be used to determine the physical state associated with core 130, along with monitored electrical signals such as ECG signaling, via telecommunications logic 181 (e.g., port, analog-to-digital conversion logic, etc.). This telecommunications logic supports the reception and processing of electrical signals received from core 130. The physical state of core 130 can be based on changes in the characteristics of reflected optical signals 150 received from core 130. These characteristics may include wavelength shift caused by strain in certain regions of the core fiber integrated within core 130 or within multi-core fiber 135 acting as core 130, as shown below. Based on the information associated with reflected optical signals 150, console 110 can determine the physical state of core 130, particularly the conduit 195 configured to receive core 130, (through wavelength shift calculation or extrapolation).

[0053] According to one embodiment of this disclosure, such as Figure 1 As shown, optical logic 180 may include a light source 182 and an optical receiver 184. The light source 182 is configured to transmit broadband incident light 155 to propagate on an optical fiber 142 included in interconnect 140, which is optically connected to a multi-core optical fiber 135 within a core 130. In one embodiment, although the light source 182 is a tunable swept-frequency laser, other suitable light sources may be used besides lasers, including semi-coherent light sources, LED light sources, etc.

[0054] Optical receiver 184 is configured to: (i) receive the returned optical signal, i.e., the reflected optical signal 150 received from the fiber-based reflective grating (sensor) manufactured in each core of the multi-core optical fiber 135 deployed within the core needle 130 (see Figure 2 (ii) the reflected optical signal 150 is translated into reflected data 185, i.e., data in the form of an electrical signal representing the reflected optical signal including wavelength shifts caused by strain. The reflected optical signal 150, associated with different spectral widths, may include a reflected optical signal 151 provided by a sensor located in the central core fiber (reference) of the multi-core fiber 135 and a reflected optical signal 152 provided by a sensor located in the peripheral core fibers of the multi-core fiber 135, as described below. In this document, the optical receiver 184 may be implemented as a photodetector, such as a positive-intrinsic-negative "PIN" photodiode, an avalanche photodiode, etc.

[0055] As shown, both the light source 182 and the optical receiver 184 are operatively connected to the processor 160, which controls their operation. Furthermore, the optical receiver 184 is operatively coupled to provide reflection data 185 to the memory 165 for storage and processing via reflection data classification logic 190. The reflection data classification logic 190 can be configured to: (i) identify which core fiber is associated with which data in the received reflection data 185, and (ii) separate the reflection data 185 provided by the reflected light signal 150 associated with a similar region or spectral width of the core needle 130 into analysis groups. The reflection data of each analysis group is then available for analysis by shape sensing analysis logic 192.

[0056] According to one embodiment of this disclosure, shape sensing analysis logic 192 is configured to compare the wavelength shift measured by sensors deployed in each peripheral core fiber at the same measurement area (or the same spectral width) of the core 130 with the wavelength shift at the central core fiber of the multi-core fiber 135, which is positioned along the central axis and acts as a neutral bending axis. Based on these analyses, shape sensing analysis logic 192 can determine the shape taken by the core fiber in 3D space and can further determine the current physical state of the guide 195 in 3D space for rendering on display 170.

[0057] According to one embodiment of this disclosure, shape sensing analysis logic 192 can generate a rendering of the current physical state of the core needle 130 (and possibly the conduit 195) based on a trial-and-error method or runtime analysis. For example, the shape sensing analysis logic 192 can be configured according to machine learning techniques to access a data storage area (library) containing pre-stored data (e.g., images, etc.) relating to different regions of the core needle 130 (or conduit 195), where reflected light from the core fiber has previously undergone similar or identical wavelength shifts. Based on the pre-stored data, the current physical state of the core needle 130 (or conduit 195) can be rendered. Alternatively, as another example, shape sensing analysis logic 192 can be configured to determine, during runtime, changes in the physical state of each region of the multi-core fiber 135 based on at least: (i) the resulting wavelength shifts experienced by the different core fibers within fiber 135, and (ii) the relationship between these wavelength shifts generated by sensors positioned along the different peripheral core fibers at the same cross-sectional area of ​​the multi-core fiber 135 and the wavelength shift generated by a sensor at the same cross-sectional area of ​​the central core fiber. It is conceivable that other processes and procedures can be performed to render appropriate changes in the physical state of the core needle 130 (and / or catheter 195) using the wavelength shifts measured by sensors along each of the core fibers within the multi-core fiber 135, particularly for guiding the core needle when it is located at the distal tip of the catheter 195, within the patient's vascular system, and at a desired destination within the body.

[0058] The console 110 may also include electrical signal receiver logic 186, which is positioned to receive one or more electrical signals from the core 130. The core 130 is configured to support both optical and electrical connectivity. The electrical signal receiver logic 186 receives electrical signals (e.g., ECG signals) from the core 130 via a conductive medium 144. The electrical signals may be processed by electrical signal analysis logic 194 (executed by the processor 160) to determine an ECG waveform for display.

[0059] Now for reference Figure 2 This demonstrates the operable connection to Figure 1 An exemplary embodiment of the core assembly 120 of the conduit 195. In this document, the core assembly 120 is characterized by a core 130 comprising an insulating layer 210 encapsulating a multi-core optical fiber 135 and / or a conductive medium 230, such as... Figures 6A to 9B As shown and described below, the core needle 130 extends distally from the shank 240, while the interconnect (e.g., tether) 250 extends proximally from the shank 240 and is terminated by the console connector 132 to couple to the interconnect 140 of the console 110, as shown below. Figure 1 As shown. The handle 240 is included in a second interconnect (e.g., a tether) 250 to assist the user in manipulating the mandrel 130 during operation, and can be configured to include, for example... Figure 1 The activation control 126 is shown.

[0060] As shown in the figure, the core needle 130 and interconnect 250 provide paths for the output optical signal generated by the light source 182 of the optical logic 180 and the returned optical signal generated by the grating within the core fiber of the multi-core fiber 135, for reception by the photodetector 184 (see Figure 184). Figure 1 The insulating layer associated with the core pin 130 and the interconnect 250 can be varied in density and material to control its rigidity and mechanical properties.

[0061] Furthermore, according to one embodiment of this disclosure, the needle assembly 120 also includes a catheter connector 270, which may be threaded to attach to a connector of an extension leg of the catheter (see [link]). Figure 3 ).like Figure 3 As shown, this connectivity between connector 270 and the connector of the extension leg can be used during the procedure of inserting the core needle 130 into the lumen of catheter 195. When deployed, the distal end of the multi-fiber 135 does not need to be substantially co-terminated with the distal tip of the catheter. As will be seen, the returned optical signals (reflected light 150) from the sensors (reflection gratings) within each core fiber included in the multi-fiber 135 can be analyzed during the advancement of the multi-fiber through the patient's vascular system.

[0062] It should be further noted that the term "heart needle" as used herein can include any of a variety of devices configured for removable placement within the lumen of a catheter (or other part of a medical device) to assist in placing the distal end of the catheter in a desired location within the patient's vascular system. Furthermore, it should be noted that other connection schemes between the heart needle 130 and the console 110 may also be used without limitation.

[0063] refer to Figure 3 An embodiment for placement of a core needle 130 within a catheter 195 is shown. In this document, catheter 195 includes an elongated catheter tube 300 defining one or more lumens 310 extending between a proximal and distal end of the catheter tube 300. The catheter tube 300 communicates with a corresponding extension leg 320 via a bifurcation hub 330. A Luer connector 340 is included on the proximal end of the extension leg 320.

[0064] As shown in the figure, the core assembly 120 includes a console connector 132 on its proximal end 350 to enable the core 130 to be operably connected to the console 110 (see Figure 110). Figure 1Interconnector 250 extends distally from console 110 to catheter connector 270, which is configured to thread (or otherwise connect) to a Luer connector 340 of one of the extension legs 320 of catheter 195. A core 130 extends distally from catheter connector 270 to its distal end 280. The distal end 280 of core 130 may substantially co-terminate with the distal tip 360 of catheter 195 within the vascular system.

[0065] Now for reference Figure 4 An embodiment of the core needle 130 is shown, illustrating the placement of the core needle within the catheter 195 when the core 195 is inserted into the vascular system of the patient 400 through the skin insertion site 410. (See illustration.) Figure 4 As shown, catheter 195 typically includes a proximal portion 420 that is generally retained outside the patient 400 and a distal portion 430 that is generally retained within the patient's vascular system after placement. A catheter needle 130 is used to assist in positioning the distal tip 360 of catheter 195 in a desired location within the patient's vascular system. In one embodiment, the desired location of the distal tip 360 is close to the patient's heart, such as, in this embodiment, in the lower third (1 / 3) portion of the superior vena cava (“SVC”). Of course, the catheter needle 130 can be used to place the distal tip 360 of catheter in other locations.

[0066] During the advancement of the conduit 195, the core needle 130 receives broadband light 155 from the console 110 via an interconnect 140, the interconnect including a connector 146 for coupling to a console connector 132 of the core needle assembly 120. Reflected light 150 from sensors (reflection gratings) within each core fiber of the multi-core fiber 135 returns from the core needle 130 via the interconnect 140 for processing by the console 120. The physical state of the core needle 130 can be determined based on analysis of the wavelength shift of the reflected light 150. For example, strain caused by bending of the core needle 130 and the resulting angular modification of each core fiber causes varying degrees of deformation. These varying degrees of deformation alter the shape of the sensors (reflection gratings) located on the core fibers, which can lead to wavelength changes (shifts) in the reflected light from sensors located on each core fiber within the multi-core fiber 135, such as… Figure 5 As shown. Based on this wavelength shift, console 110 (see...) Figure 1 The shape sensing analysis logic 192 within the core can determine the physical state of the core needle 130 (e.g., shape, orientation, etc.).

[0067] refer to Figure 5 An exemplary embodiment is shown, in a right-hand longitudinal view, of a cross-section 500 of the multi-core optical fiber 135 included within the core needle 130. The multi-core optical fiber cross-section 500 depicts certain core optical fibers 5101 to 510.M (M≥2, M=4, as shown in the figure) together with the core optical fibers 5101 to 510 respectively. M Internal sensors (e.g., reflective gratings) 520 11 -520 NM The spatial relationship between (N≥2; M≥2) is shown in the figure. Section 500 is subdivided into multiple cross-sectional regions 5301 to 530. N Each cross-sectional region is 5301 to 530. N Corresponding to the reflection grating 520 11 Up to 520 14 ...520 N1 Up to 520 N4 Cross-sectional region 5301...530 N Some or all of them can be static (e.g., a specified length) or dynamic (e.g., within regions 5301...530). N (with variations in size). The first fiber 5101 is positioned substantially along the central (neutral) axis 550, while the second fiber 5102 can be oriented from the frontal angle of the cross-section within the cladding of the multi-core fiber 130 to be positioned on top of the first fiber 5101. In this deployment, the second fibers 5103 and 5104 can be positioned on the lower left and lower right of the first fiber 5101, respectively.

[0068] Referring to the first optical fiber 5101 as an illustrative example, when the core needle 130 is operating, the reflection gratings 5201 to 520... N Each element in the grating reflects light with a different spectral width. As shown in the figure, grating 520... 1i Up to 520 Ni Each of (1≤i≤M) is associated with a different specific spectral width, which will be determined by f1...f N The different center frequencies are represented, wherein the adjacent spectral widths reflected by adjacent gratings do not overlap according to an embodiment of the present disclosure.

[0069] In this paper, the same cross-sectional regions 530 to 530 are located in different core fibers 5102 to 5103 but along the multi-core fiber 135. N grating 520 12 Up to 520 N2 and 520 13 Up to 520 N3The incident light is configured to reflect the same (or substantially similar) center frequency. As a result, the reflected light returns information that allows the physical state of the fiber 135 (and the mandrel 130) to be determined based on wavelength shifts measured from the returned reflected light. Specifically, strain (e.g., compression or stretching) applied to the multi-core fiber 135 (e.g., at least core fibers 5102 to 5103) results in a wavelength shift associated with the returned reflected light. Depending on their location, core fibers 5101 to 5104 experience different types and degrees of strain based on changes in their angular path as the mandrel 130 advances within the patient.

[0070] For example, regarding Figure 5 The multi-core fiber cross-section 500, in response to the angular (e.g., radial) movement of the core needle 130 along the left-veering direction, has a fourth core fiber 5104 with the shortest radius during movement (see...). Figure 6A (For example, the core fiber closest to the direction of angular change) will exhibit compression (e.g., shortening in length due to force). Simultaneously, the third core fiber 5103, having the longest radius during movement (e.g., the core fiber furthest from the direction of angular change), will exhibit stretching (e.g., increasing in length due to force). Since these forces are different and unequal, the reflection grating 520 associated with core fibers 5102 and 5103 will... N2 and 520 N3 The reflected light will exhibit different wavelength changes. The difference between the wavelength shift of the reflected light signal 152 and the wavelength of a reference core fiber (e.g., the first core fiber 5101) positioned along the neutral axis 550 of the multi-core fiber 135 can be used to extrapolate the physical configuration of the core needle 130 by determining the degree of wavelength change caused by compression / stretching of each of the peripheral fibers (e.g., the second core fiber 5102 and the second core fiber 5103). These degrees of wavelength change can be used to extrapolate the physical state of the core needle 130.

[0071] Now for reference Figure 6A , showed Figure 1 A first exemplary embodiment of a multimode core 130 supporting both optics and telecommunications is provided. Hereinafter, the core 130 is characterized by a centrally located multi-core optical fiber 135, the multi-core optical fiber including a cladding 600 and residing in corresponding plurality of cavities 6201 to 620. M The multi-core optical fibers 5101 to 510 inside M (M≥2; M=4). Although multi-core fiber 135 is shown in four (4) core fibers 5101 to 5104, a greater number of core fibers 5101 to 510 can be deployed. M(M>4) to provide more detailed three-dimensional sensing of the physical state (e.g., shape, orientation, etc.) of the multi-core optical fiber 135 and the mandrel 130 for deploying the optical fiber 135, and to deploy a greater number of core optical fibers 5101 to 510. M (M>4).

[0072] In this embodiment of the present disclosure, the multi-core optical fiber 135 is encapsulated within a concentric braided tube 610 located above a low-friction coefficient layer 635. The braided tube 610 may be characterized by a “mesh” configuration, wherein the spacing between intersecting conductive elements is selected based on the required rigidity of the core 130, as a larger spacing can provide less rigidity, thereby providing a more flexible core 130.

[0073] According to this embodiment of the disclosure, such as Figures 6A to 6B As shown, the core optical fibers 5101 to 5104 include (i) a central core optical fiber 5101 and (ii) multiple peripheral core optical fibers 5102 to 5104, which are maintained within cavities 6201 to 6204 formed in the cladding 600. According to one embodiment of this disclosure, one or more of the cavities 6201 to 6204 may be configured with a diameter designed to be larger than the diameter of the core optical fibers 5101 to 5104. By avoiding direct physical contact between a large portion of the surface area of ​​the core optical fibers 5101 to 5104 and the wall surface of the cavities 6201 to 6204, the wavelength variation of the incident light is caused by the angular offset in the multi-core optical fibers 135, thereby reducing the wavelength applied to the cavities 6201 to 6204. M The wall of the fiber instead of the core fiber 5101 to 510 M The effects of compression and stretching itself.

[0074] like Figures 6A to 6B As further shown, the core optical fibers 5101 to 5104 may include: a central core optical fiber 5101, which resides in a center or a first cavity 6201 formed along the first neutral axis 550; and multiple core optical fibers 5102 to 5104 residing in cavities 6202 to 6204, each formed in a different region of the cladding 600 radiating from the first neutral axis 550. Typically, in addition to the central core optical fiber 5101, the core optical fibers 5102 to 5104 may be located in different regions within the cross-sectional region 605 of the cladding 600 based on the wavelength variation of the incident light propagating through the core optical fibers 5102 to 5104 and reflected back to the console for analysis, to provide sufficient spacing to enable three-dimensional sensing of the multi-core optical fiber 135.

[0075] For example, the cladding 600 is characterized as follows: Figure 6BIn the case of the circular cross-sectional region 605 shown, as measured along the periphery of the cladding 600, the core fibers 5102 to 5104 can be positioned substantially equidistant from each other, such as at the "top" (12 o'clock), "lower left" (8 o'clock), and "lower right" (4 o'clock) positions, as shown. Therefore, in general, core fibers 5102 to 5104 can be located within different segments of the cross-sectional region 605. In the case where the cross-section 605 of the cladding 600 is characterized by a polygonal cross-sectional shape (e.g., triangle, square, rectangle, pentagon, hexagon, octagon, etc.), the central core fiber 5101 can be located at or near the center of the polygon, while the remaining core fibers 5102 to 5104... M It can be located near the angle between the intersecting edges of a polygon.

[0076] Still referencing Figures 6A to 6B When acting as the conductive medium for the core needle 130, the braided tube 610 provides mechanical integrity for the multi-core optical fiber 135 and serves as a conductive path for electrical signals. For example, the braided tube 610 may be exposed at the distal tip 630 of the core needle 130. The cladding 600 and the braided tube 610, concentrically positioned around the cladding 600, are contained within the same insulating layer 650. The insulating layer 650 may be a sheath or conduit made of a protective insulating (e.g., non-conductive) material that encapsulates both the cladding 600 and the braided tube 610, as shown in the figure.

[0077] In one embodiment of this disclosure, a conductive material such as conductive epoxy 640 may be attached to the tip 630, wherein the braided tube 610 and / or conductive epoxy 640 may similarly engage with a termination / connection point formed on the proximal portion of the mandrel 130. It is contemplated that the shank 240 may include a crimp / weld joint to facilitate an electrical transition (electrical connection) between the braided tube 610 within the mandrel 130 and the wire in the tether 250, which provides connectivity for the interconnects 140 of the control console 110. It is conceivable that other electrical connection mechanisms can be deployed between the tether 250 and the braided tube 610, such as the abutment of the braided tube 610 with a conductive element (grid, washer, or ring) located on the proximal portion (or proximal end) of the core needle 130 (connectivity with the tether 250), by abutting the braided tube 610 with a conductive tab / bar integrated in the shank 240 to allow wiring through the tether 250, or by deploying the connectivity through a threaded interface.

[0078] Now for reference Figure 7A , showed Figure 1 A second exemplary embodiment of the multimodal mandrel 130, supporting both optics and telecommunications, is described herein. The mandrel 130 is characterized by... Figure 6AThe multi-core optical fiber 135 shown includes a cladding 600 and multiple cavities 6201 to 620 residing in corresponding cavities. M The first multi-core optical fiber 5101 to 510 inside M (For embodiments, M≥3; M=4). For this embodiment of the present disclosure, the multi-core optical fiber 135 includes: a central core optical fiber 5101 residing within a center or first cavity 6201 formed along a first neutral axis 550; and second multi-core optical fibers 5102 to 5104 residing within corresponding cavities 6202 to 6204 in different segments located within a cross-sectional region 605 of the cladding 600. In this document, it can be understood through the above description and... Figures 6A to 6B The deployment shown is similar to that of core optical fibers 5101 to 510. M .

[0079] and Figures 6A to 6B Compared to the use of the braided tube 610 shown, the multi-core optical fiber 135 of the multimode core needle 130 can be paired with a conductive medium 700 such as an electrical wire. According to this embodiment of the present disclosure, as... Figure 7A As shown, the conductive medium 700 is configured to transmit electrical (e.g., ECG) signals received by the needle 130 after the needle 130 is placed inside the patient. In this embodiment, the conductive medium 700 is positioned without isolation from the multi-core fiber 135, wherein the conductive medium 700 extends in length adjacent to the outer surface 710 of the cladding 600.

[0080] In one embodiment of this disclosure, the handle 240 may include a crimp / weld joint to provide electrical connectivity between conductive media 700 within the wires within the tether 250. Other electrical connection mechanisms to the conductive media are contemplated, as described above.

[0081] like Figures 7B to 7C As shown in the cross-sectional view of the core needle 130, the multi-core optical fiber 135 and the conductive medium 700 can be placed in parallel, wherein the optical fiber 135 and the conductive medium 700 are encapsulated within the same insulating layer 720. In this embodiment of the present disclosure, the insulating layer 720 acts as a protective shell for both the multi-core optical fiber 135 and the conductive medium 700, wherein the conductive medium 700 can have direct physical contact with the cladding 600. Figure 7B As shown, the insulating layer 720 acts as a single shell, wherein the conductive dielectric 700 is not shielded (insulated) from the cladding 600 of the multi-core optical fiber 135. In contrast, as... Figure 7C As shown, the insulating layer 720 acts as a double shell, in which the conductive medium 700 is shielded (insulated) from the cladding 600 of the multi-core optical fiber 135.

[0082] refer to Figure 8A , showed Figure 1A third exemplary embodiment of the multimodal mandrel 130, which supports both optics and telecommunications, is provided. In this document, the multimodal mandrel 130 is characterized by... Figure 6A The multi-core optical fiber 135 shown includes a cladding 600 and multiple cavities 6201 to 620 residing in corresponding cavities. M The first multi-core optical fiber 5101 to 510 inside M (For the embodiments, M≥3; M=4). In this embodiment of the present disclosure, the multi-core optical fiber 135 includes: a central core optical fiber 5101 residing within a center or a first cavity 6201 formed along a first neutral axis 550; and second multi-core optical fibers 5102 to 5104 residing within corresponding cavities 6202 to 6204 in different segments within a cross-sectional region 605 of the cladding 600. In this document, the multi-core optical fiber 135 may be paired with a flexible circuit 800 (i.e., a flexible printed circuit extending along the length of the multi-core optical fiber 135).

[0083] like Figures 8A to 8B As shown, the flexible circuit 800 is configured to propagate any electrical (e.g., ECG) signal detected by the core needle 130. The flexible circuit 800 resides along the outer surface 810 of the cladding 600 and can be encapsulated within an insulating layer (channel) 820. According to one embodiment of this disclosure, the flexible circuit 800 can be attached to the cladding 600 of the multi-core optical fiber 135 via one or more electrical attachment members 820, which can be electrically isolated from the multi-core optical fiber 135. The electrical attachment members 820 may be characterized by a crimping mechanism, one or more weld joints, etc. For example, Figure 1 The shank 240 of the core assembly 120 attached to the core 130 can be used as a crimping mechanism to establish connectivity between the flexible circuit and the wires provided via the tether 250 of the core assembly 120.

[0084] Now for reference Figure 9A , showed Figure 1 A fourth exemplary embodiment of the multimodal mandrel 130, which supports both optics and telecommunications, is provided. In this document, the multimodal mandrel 130 is characterized by the features described above and in… Figure 6A The multi-core optical fiber 135 shown includes a cladding 600 and multiple cavities 6201 to 620 residing in corresponding cavities. M The first multi-core optical fiber 5101 to 510 inside M(For embodiments, M≥3; M=4). In this embodiment of the present disclosure, the multi-core optical fiber 135 includes: a central core optical fiber 5101 residing within a center or a first cavity 6201 formed along a first neutral axis 550; and second multi-core optical fibers 5102 to 5104 residing within corresponding cavities 6202 to 6204 in different segments within a cross-sectional region 605 of the cladding 600. Hereinafter, the multi-core optical fiber 135 is encapsulated within a conductive tube 900. The conductive tube 900 may be characterized by a “hollow” conductive cylindrical member concentrically encapsulating the multi-core optical fiber 135. This conductive tube 900 may be formed of a metal or an alloy including shape memory alloys such as nitinol.

[0085] refer to Figures 9A to 9B The conductive tube 900, which acts as the conductive medium of the mandrel 130 when transmitting electrical signals (e.g., ECG signals) to the control console, can be exposed all the way to the tip 910 of the mandrel 130. For this embodiment of the present disclosure, a conductive epoxy resin 920 (e.g., a metal-based epoxy resin, such as silver epoxy) can be fixed to the tip 910 and similarly engage with a termination / connection point generated at the proximal end 930 of the mandrel 130. Figure 1 As shown, the electrical path can continue through the shank 240 to the connector 132 located on the proximal end 124 of the interconnect 144 of the core assembly 120. Alternatively, the shank 240 can provide electrical coupling between the conductive tube 900 and a wire included as part of the interconnect 144 with the multi-core optical fiber 330. The cladding 600 and the conductive tube 900, concentrically positioned around the cladding 600, are contained within the same insulating layer 940. As shown, the insulating layer 940 can be a protective conduit encapsulating both the cladding 600 and the conductive tube 900.

[0086] Now for reference Figure 10A , showed Figure 1 A fifth exemplary embodiment of the multimodal mandrel 130 supporting both optics and telecommunications is provided. In this document, the mandrel 130 is characterized by... Figure 6A The multi-core optical fiber 135 shown includes a cladding 600 and multiple cavities 6201 to 620 residing in corresponding cavities. M The first multi-core optical fiber 5101 to 510 inside M (For embodiments, M≥3; M=4). For this embodiment of the present disclosure, the multi-core optical fiber 135 includes: a central core optical fiber 5101 residing within a center or first cavity 6201 formed along a first neutral (e.g., central) axis 550; and second multi-core optical fibers 5102 to 5104 residing within corresponding cavities 6202 to 6204 in different segments located within a cross-sectional region 605 of the cladding 600. In this document, it can be understood through the above description and... Figures 7A to 7C The deployment shown is similar to that of core optical fibers 5101 to 510. M .

[0087] and Figure 7A Compared to paired optical cable deployments, the conductive medium 1000 is contained within the channel 1010, and a portion of the multi-core optical fiber 135 resides within the channel, wherein the conductive medium 1000 may extend in the length direction and remain adjacent to a segment 1020 of the surface region of the cladding 600. The extent of inclusion may include at least partially encapsulating the multi-core optical fiber 135 (see [link to documentation]). Figure 10C ) or essentially packaged (see Figure 10D Within channel 1010 of conductive medium 1000. For example... Figure 10C As shown, a portion of the circumference of the multi-core optical fiber 135 (e.g., varying between 40% and 60% of the circumference) can be held within the channel 1010, wherein the first channel edge 1030 to the second channel edge 1040 can extend slightly beyond the diameter bisector of the cross-sectional region 605 of the conductive medium 1000. Figure 10D In this process, a significant portion of the circumference of the multi-core optical fiber 135 (e.g., more than 60 percent of the circumference) can be held within the channel 1010, thereby "snapped" the optical fiber 135 into the channel 1000, because the width of the opening 1060 of the channel 1010 can be smaller than the width of the channel 1065 in which the optical fiber 135 is held and the width of the opening 1070 of the channel 1010 (e.g., ...). Figure 10C The width of the fiber optic sheath (as shown) (but when the sheath is made of a flexible material, it is slightly larger than, equal to or slightly smaller than the width of the fiber optic sheath).

[0088] As shown in the cross-sectional view of the first embodiment of the core needle 130, in Figure 10B In this embodiment, the multi-core optical fiber 135 and the conductive medium 1000 can be placed in parallel, wherein the optical fiber 135 resides within a channel 1010 formed as a recess or groove portion on the conductive medium (e.g., a wire) 1000, and is encapsulated within an optional insulating layer 1050. For this embodiment of the present disclosure, the insulating layer 1050 acts as a protective housing for both the multi-core optical fiber 135 and the conductive medium 1000, wherein the conductive medium 1000 can be in direct physical contact with the cladding 600 as shown, or can be insulated (shielded) from the cladding 600. Figures 10C to 10D A cross-sectional view of another embodiment of the core needle 130 is shown, in which the optical fiber 135 is more encapsulated within the channel 1010.

[0089] Now for reference Figure 11A and 11B , showed Figure 1A sixth exemplary embodiment of the multimodal mandrel 130 supporting both optics and telecommunications is provided herein. The mandrel 130 is characterized by... Figure 6A The multi-core optical fiber 135 shown includes a cladding 600 and multiple cavities 6201 to 620 residing in corresponding cavities. M The first multi-core optical fiber 5101 to 510 inside M (For the embodiments, M≥3; M=4), as described above in the section on... Figure 9A and 9B The description of the fourth exemplary embodiment of the multimodal core 130 is as set forth herein, and such description is incorporated herein so as not to burden the present disclosure. However, with Figure 9A and 9B Unlike the multimode core 130, the multi-core optical fiber 135 is simply encapsulated within the conductive tube 900 and optionally fixed thereto with conductive epoxy resin 920; excluding Figure 9A and 9B The insulating layer 940 is shown. The conductive tube 900 is characterized by concentrically encapsulating a "hollow" conductive cylindrical component of the multi-core optical fiber 135. This conductive tube 900 can be formed of metal or an alloy including shape memory alloys such as nitinol.

[0090] Embodiments of the present invention may be implemented in other specific forms without departing from the spirit of this disclosure. The described embodiments should be considered in all respects as illustrative rather than restrictive. Therefore, the scope of the embodiments is indicated by the appended claims rather than the foregoing description. All variations within the meaning and scope of the equivalents of the claims are included within the scope of these claims.

Claims

1. A medical device comprising: A multi-core optical fiber, comprising a cladding and one or more core optical fibers spatially arranged within the cladding, each of the one or more core optical fibers comprising a plurality of sensors distributed along the longitudinal length of the core optical fiber, and each of the plurality of sensors being configured to: (i) Based on the received incident light, the optical signal is reflected into reflected light with different spectral widths, and (ii) Change the characteristics of the reflected light signal to determine the physical state of the multi-core optical fiber; as well as A conductive medium configured to provide a path for an electrical signal detected at a distal portion of the conductive medium. The one or more core optical fibers include a central core optical fiber and two or more core optical fibers. The central core optical fiber resides in a central cladding cavity formed along a first axis, and the two or more core optical fibers each reside in two or more corresponding cladding cavities formed in different regions of the cladding parallel to the first axis.

2. The medical device according to claim 1, further comprising: An insulating layer, wherein the multi-core optical fiber is encapsulated in the insulating layer, and the conductive medium is encapsulated in the insulating layer.

3. The medical device according to claim 1, wherein the medical device corresponds to a multimodal catheter.

4. The medical device of claim 1, wherein each of the plurality of sensors constitutes a reflective grating located in a different region along the longitudinal length of the core optical fiber.

5. The medical device of claim 1, wherein the change in the characteristics of the reflected light comprises a shift in wavelength applied to the reflected light signal to identify at least a type of strain.

6. The medical device of claim 5, wherein the type of strain is compression or tension.

7. The medical device according to claim 1, wherein the electrical signal includes an electrocardiogram signal.

8. The medical device of claim 1, wherein the conductive medium corresponds to a braided tube concentrically positioned with respect to the cladding of the multi-core optical fiber.

9. The medical device of claim 8, wherein the distal end of the braided tube and the distal end of each of the one or more core optical fibers are exposed at the distal end of the medical device.

10. The medical device according to claim 9, further comprising: A conductive material is positioned at least at the distal end of the braided tube and is configured to electrically couple the distal end of the braided tube to an electrical terminal located at the proximal end of the medical device.

11. The medical device of claim 1, wherein the conductive medium corresponds to a conductive tube concentrically positioned with respect to the cladding of the multi-core optical fiber.

12. The medical device of claim 11, wherein the conductive tube is a nitinol tube.

13. The medical device of claim 11, wherein the medical device does not include an insulating layer encapsulating the conductive tube.

14. The medical device of claim 2, wherein the conductive medium comprises one or more wires located within a first insulating layer cavity formed by the insulating layer, and the cladding of the multi-core optical fiber is located within a second insulating layer cavity formed by the insulating layer.

15. The medical device of claim 14, wherein the one or more wires and the multi-core optical fiber are electrically isolated through a portion of the first insulating layer cavity, a portion of the second insulating layer cavity, or a portion of the first insulating layer cavity and the second insulating layer cavity.

16. The medical device of claim 1, wherein the conductive medium comprises a flexible circuit that resides along the outer surface of the cladding and is distributed along the length of the multi-core optical fiber.

17. The medical device of claim 1, wherein the first axis is the central axis of the multi-core optical fiber having a circular cross-sectional region, and the two or more core optical fibers comprise: The first optical fiber resides within the first cladding cavity, located within a first arc-shaped segment of the circular cross-section region, along a first radial direction from the central cladding cavity. The second optical fiber, which resides in the second cladding cavity within a second arc-shaped section separated from the first arc-shaped section in the circular cross-sectional region, along a second radial direction from the first cladding cavity, and... The third optical fiber is located in the third cladding cavity, which is separated from the first arc-shaped section and the second arc-shaped section in the circular cross-sectional region, and is situated in the third arc-shaped section along the third radial direction from the first cladding cavity.

18. The medical device of claim 1, wherein the one or more core optical fibers comprise: A central core optical fiber, which resides within a central cladding lumen formed along the central axis of the cladding. And each of two or more core optical fibers, each core optical fiber residing in a cavity parallel to the central axis, such that each core optical fiber is radially positioned closer to the edge of the cladding than the central core optical fiber.

19. The medical device of claim 18, wherein the two or more core optical fibers comprise: The first optical fiber resides within a first cladding cavity formed coplanar with the central cladding cavity; The second optical fiber resides in a second cladding cavity that is radially positioned from the central cladding cavity, forming a first obtuse angle between the first cladding cavity and the second cladding cavity; And a third optical fiber, which resides in a third cladding cavity located radially from the central cladding cavity, forming a second obtuse angle between the first cladding cavity and the third cladding cavity, and forming a third obtuse angle between the second cladding cavity and the third cladding cavity.

20. The medical device of claim 1, wherein the physical state of the multi-core optical fiber includes one or more of the following: the length, shape, form, or orientation of the multi-core optical fiber or a portion thereof at that moment.

21. The medical device of claim 20, wherein the physical state of the multi-core optical fiber implemented within the core represents the immediate physical state of the catheter, wherein the core is inserted into the catheter during the advancement of the core into the patient.

22. The medical device of claim 1, wherein the multi-core optical fiber is positioned to reside within a channel of the conductive medium.

23. The medical device of claim 22, wherein the conductive medium is a wire, the wire including a groove along the surface of the wire to form the channel.

24. The medical device of claim 1, wherein the conductive medium includes one or more channels along the surface of the conductive medium and each of the one or more channels for holding at least one of the core optical fibers.

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