Automatic dimensional reference system for optical fibers

Abstract

Disclosed herein are systems, devices, and methods related to placing a medical device into a patient's body, each of which performs or includes the operations of providing a broadband incident light signal to a plurality of core fibers of a multi-core optical fiber; receiving a reflected light signal of a different spectral width; processing the reflected light signal associated with the plurality of core fibers to determine (i) a physical state of the multi-core optical fiber related to the medical device comprising the multi-core optical fiber and (ii) an orientation of the multi-core optical fiber relative to a frame of reference of the body. Other operations include generating a display showing the physical state of the multi-core optical fiber based at least on the orientation determined during processing of the reflected light. Typically, the display is a two-dimensional representation of the multi-core optical fiber according to the determined orientation.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 045,667, filed June 29, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to an automated dimensional reference system for optical fibers. Background Technology

[0004] In the past, certain intravascular guidance methods for medical devices (such as guidewires and catheters) have used fluorescence imaging techniques to track the tip of the device and determine whether the distal tip is properly positioned within its target anatomical structure. However, such fluorescence imaging 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 imaging.

[0005] Recently, electromagnetic tracking systems involving a needle have been used. Typically, an electromagnetic tracking system consists of three components: a field generator, a sensor unit, and a control unit. The field generator uses multiple coils to generate a magnetic field that establishes the positional changes in coordinate space. For example, attached to a needle (such as near its distal end (tip), the sensor unit includes a small coil in which a current is induced via the magnetic field. Based on the electrical characteristics of each coil, the position and orientation of the medical device can be determined in coordinate space. The control unit controls the field generator and captures data from the sensor unit.

[0006] While electromagnetic tracking systems avoid the line-of-sight dependence of tracking needle tips and avoid radiation exposure and potentially harmful contrast agents associated with fluorescence examination methods, they are susceptible to interference. More specifically, because electromagnetic tracking systems rely on the measurement of magnetic fields generated by a field generator, they experience electromagnetic interference, which can be caused by the presence of many different types of consumer electronic devices, such as cellular phones. Additionally, electromagnetic tracking systems experience signal loss, rely on external sensors, and are limited by a finite depth range.

[0007] This document discloses a fiber optic shape sensing system and method that does not suffer from the drawbacks associated with electromagnetic tracking systems as described above, and is capable of providing confirmation of tip placement or providing information as electrical signals transmitted / interpreted in its current form. Furthermore, a system and method of the invention are disclosed, configured to determine the orientation of a catheter needle advanced within a patient's vascular system based at least in part on information transmitted / interpreted as electrical signals. Additionally, such a system and method of the invention are disclosed, which can perform or include operations of displaying information received from the fiber optic shape sensing system based on the determined orientation. Summary of the Invention

[0008] In short, the embodiments disclosed herein relate to obtaining three-dimensional (3D) information (reflected light) corresponding to the trajectory and / or shape of a medical device, such as a catheter, guidewire, or needle, during advancement through a patient's vascular system, determining the orientation of the medical device relative to the patient, and generating and presenting a two-dimensional (2D) display of the medical device in real time based on the determined orientation.

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

[0010] Reflected light from sensors (reflective gratings) within each core fiber of a multi-core optical fiber returns from the medical device for processing by a control console. The physical state of the medical device can be determined based on analysis of the wavelength shift of the reflected light. For example, strain caused by bending of the medical device and the resulting angular change in each core fiber causes varying degrees of deformation. These varying degrees of deformation alter the shape of the sensors (reflective gratings) positioned on the core fibers, which may cause a change (shift) in the wavelength of the reflected light from the sensors positioned on each core fiber within the multi-core optical fiber, such as... Figure 2 , 7 As shown in Figure 10.

[0011] Based on this wavelength shift, the logic within the console can determine the physical state (e.g., shape) of the medical device. Furthermore, based on the wavelength shift and the anatomical constraint of the patient's body, the logic within the console can determine the orientation of the medical device relative to a known reference frame of the patient's body. The logic within the console is then configured to generate a 2D display of the physical state of the medical device using this determined orientation, where the 2D display's reference frame is mirrored with that of the patient's body. Therefore, the 2D display depicts the current physical state of the catheter in a manner representing its anatomical location and orientation relative to the patient's body, enabling clinicians to perceive the advancement of the medical device in an anatomically appropriate manner.

[0012] Specific embodiments of the disclosed text include the use of a core needle 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. The core needle is configured to return information for identifying: (i) a portion of the core needle (e.g., a tip, segment, etc.) or a portion of a catheter comprising at least a portion of the core needle (e.g., a tip, segment, etc.); or (ii) the physical state (e.g., shape-length, shape, and / or form) of all or most of the core needle or catheter within the patient (hereinafter described as "physical state of the core needle" or "physical state of the catheter"). According to one embodiment of the disclosed text, the returned information can be obtained from reflected light signals of varying spectral widths, where each reflected light signal corresponds to a portion of broadband incident light propagating along the core of the multi-core optical fiber (hereinafter referred to as the "core fiber"), which is reflected back above the core fiber by a specific sensor located on the core fiber. An illustrative embodiment of the returned information may involve variations in the signal characteristics of the reflected light signals returned from the sensors, where the wavelength shift is related to (mechanical) strain on the core fiber.

[0013] In some embodiments, the mandrel comprises a multi-core optical fiber, wherein each core fiber utilizes multiple sensors and each sensor is configured to reflect incident light in a different spectral range (e.g., different optical frequency ranges). Based on the type and degree of strain applied to each core fiber, the sensor associated with that core fiber can alter (offset) the wavelength of the reflected light to transmit the type and degree of strain on that core fiber at those locations on the mandrel occupied by the sensor. The sensors are spatially distributed at different locations on the core fibers between the proximal and distal ends of the mandrel, allowing shape sensing of the mandrel to be performed based on wavelength offset analysis. Here, the shape sensing function is paired with the ability to transmit electrical signals through a conductive medium included as part of the mandrel, while simultaneously through the same component (the mandrel).

[0014] More specifically, in some embodiments, each core fiber of the multi-core optical fiber is configured with a sensor array spatially distributed over a predetermined length of the core fiber to substantially sense external strain on the areas of the core fiber occupied by the sensors. With each sensor positioned along the same core fiber configured to reflect light of a different specific spectral width, the sensor array enables distributed measurements over the entire predetermined length of the multi-core optical fiber. These distributed measurements may include wavelength shifts correlated with the strain experienced by the sensors.

[0015] According to one embodiment of the published text, each sensor can operate as a reflective grating, such as a fiber Bragg grating (FBG), an intrinsic sensor corresponding to a permanent, periodic refractive index change inscribed into the core fiber. In other words, the sensor operates as a light mirror with a specific spectral width (e.g., a specific wavelength or wavelength range). As a result, when broadband incident light is provided by an optical source and propagates through a specific core fiber, once it reaches the first sensor in the distributed sensor array for that core fiber, the light with the 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 spectrum of the incident light continues to propagate through the core fiber toward the distal end of the core needle. The remaining spectrum of the incident light may encounter other sensors from the distributed sensor array, each of which is manufactured to reflect light with a different specific spectral width, thus providing distributed measurements as described above.

[0016] During operation, multiple light reflections (also referred to as “reflected light signals”) return to the console from each of the multiple core fibers of 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. Here, the core fibers are spatially separated from the cladding of the multimode fiber, and each core fiber is configured to return light of a different spectral width (e.g., a specific wavelength or range of light) reflected from a distributed sensor array fabricated in each core fiber. A comparison of the detected wavelength offsets of the reflected light returned by the central core fiber (as a reference operation) and the peripheral core fibers can be used to determine the physical state of the core needle.

[0017] During vascular system insertion and catheter advancement, clinicians can rely on a console to visualize the current physical state (e.g., shape) of the catheter guided by the core fiber, thus avoiding potential path deviations. As the peripheral core fibers are located at different spatial positions within the cladding of the multimode fiber, changes in the angular orientation of the core fiber (e.g., bending relative to the central core fiber) impose different types and degrees of strain (e.g., compression or tension) on each peripheral core fiber and the central core fiber. These different types and / or degrees of strain may cause different wavelength shifts applied to the sensors on the core fibers, which can be measured to infer the physical state of the core fiber (catheter).

[0018] To enable clinicians to visualize the current physical state of the catheter using a console, the console displays a visual representation (typically a 2D image) of the catheter's physical state based on reflected light. When generating the 2D image of the catheter's physical state, the image must be displayed in a manner representing its anatomical location relative to the patient's body. Therefore, after analyzing the reflected light, the console's logic determines the orientation of the catheter needle relative to a known frame of reference on the patient's body. The logic then generates and presents a 2D display of the catheter's physical state and a representation of the patient's body, showing the catheter appropriately oriented relative to the patient's body based on the determined orientation of the catheter needle.

[0019] While reflected light provides a wealth of information about the physical state of the catheter, enabling its extension, this information lacks context regarding the orientation of the catheter as it is advanced within the patient's body. For example, a wavelength shift in reflected light can indicate the different degrees of deformation of each core fiber, which can collectively indicate the bending of the catheter; however, such an indication of bending lacks context regarding its orientation or direction relative to the patient's body. Therefore, a wavelength shift in reflected light alone cannot enable logic to generate a 2D display of the catheter's physical state, appropriately oriented within the visual representation of the patient's body.

[0020] The disclosed implementation describes how the console logic determines the orientation of the catheter relative to the patient's body using known anatomical constraints of the human body, the known insertion site of the catheter within the patient, and / or the wavelength shift of reflected light. Further implementations describe generating a display showing the catheter within the patient based on the orientation of the catheter positioned within the catheter. Typically, such a display is 2D; however, the generation of a 3D display has also been considered because the wavelength shift of reflected light provides 3D information.

[0021] Some embodiments of the present invention disclose a method for placing a medical device into a patient's body, comprising: providing a broadband incident light signal to each of a plurality of reflective gratings distributed along the length of each of a plurality of core fibers of a multi-core optical fiber, the plurality of core fibers being spatially distributed to experience different degrees of strain; receiving light signals of different spectral widths of the broadband incident light reflected by each of the plurality of reflective gratings; and processing the reflected light signals received from each of the plurality of reflective gratings associated with the plurality of core fibers to determine (i) the physical state of the multi-core optical fiber associated with the medical device comprising the multi-core optical fiber and (ii) the orientation of the multi-core optical fiber relative to a reference frame of the body.

[0022] Some implementations also include generating a display showing the physical state of the multi-core optical fiber, based at least on the orientation determined during the processing of the reflected light. Alternatively, the display may be a two-dimensional representation of the physical state of the multi-core optical fiber according to the orientation determined during the processing of the reflected light.

[0023] In some embodiments, the physical state of the multi-core optical fiber associated with the medical device includes one or more of the length, shape, or form that the multi-core optical fiber currently possesses. In further embodiments, different types of strain include compression and tension.

[0024] In some instances, determining the orientation of the multi-core fiber relative to a reference frame of the body includes: establishing a reference frame of the body using a coordinate system; establishing an initial propulsion direction for the multi-core fiber along a first axis of the coordinate system based on the multi-core fiber entering the body at a known insertion site; associating an initial reflected light signal with the initial propulsion direction along the first axis of the coordinate system; detecting bending during propulsion of the multi-core fiber based on processing of the reflected light signal; and associating a reflected light signal corresponding to the bending during propulsion with a second propulsion direction along a second axis of the coordinate system, wherein the orientation is defined by (i) the initial reflected light signal associated with the initial propulsion direction along the first axis of the coordinate system and (ii) the reflected light signal corresponding to the bending during propulsion associated with the second propulsion direction along the second axis of the coordinate system. The medical device may include an elongated vascular system inserted into a patient's body. In some embodiments, the medical device is a core needle removably inserted into the lumen of a catheter assembly for positioning the distal tip of the catheter assembly in the superior vena cava of the vascular system. Further, at least two of the plurality of core fibers may be configured to undergo different types of strain in response to changes in the orientation of the multi-core fiber. In some implementations, each of the multiple reflective gratings alters its reflected light signal by applying a wavelength offset that depends on the strain experienced by the reflective grating.

[0025] Some embodiments of the present invention disclose a non-transitory computer-readable medium having logic stored thereon, which, when executed by one or more processors, causes operations including: providing a broadband incident light signal to each of a plurality of reflection gratings distributed along the length of each of a plurality of core fibers of a multi-core optical fiber, the plurality of core fibers being spatially distributed to experience different degrees of strain; receiving light signals of different spectral widths of broadband incident light reflected by each of the plurality of reflection gratings; and processing the reflected light signals received from each of the plurality of reflection gratings associated with the plurality of core fibers to determine (i) the physical state of the multi-core optical fiber associated with a medical device comprising the multi-core optical fiber and (ii) the orientation of the multi-core optical fiber relative to a reference frame of the body.

[0026] Some implementations also include generating a display showing the physical state of the multi-core fiber based at least on the orientation determined during the processing of the reflected light. Alternatively, the display may be a two-dimensional representation of the physical state of the multi-core fiber according to the orientation determined during the processing of the reflected light.

[0027] In some embodiments, the physical state of the multi-core optical fiber associated with the medical device includes one or more of the length, shape, or form that the multi-core optical fiber currently possesses. In further embodiments, different types of strain include compression and tension.

[0028] In some instances, determining the orientation of the multi-core fiber relative to a reference frame of the body includes: establishing a reference frame of the body using a coordinate system; establishing an initial propulsion direction for the multi-core fiber along a first axis of the coordinate system based on the multi-core fiber entering the body at a known insertion site; associating an initial reflected light signal with the initial propulsion direction along the first axis of the coordinate system; detecting bending during propulsion of the multi-core fiber based on processing of the reflected light signal; and associating a reflected light signal corresponding to the bending during propulsion with a second propulsion direction along a second axis of the coordinate system, wherein the orientation is defined by (i) the initial reflected light signal associated with the initial propulsion direction along the first axis of the coordinate system and (ii) the reflected light signal corresponding to the bending during propulsion associated with the second propulsion direction along the second axis of the coordinate system. The medical device may include an elongated vascular system inserted into a patient's body. In some embodiments, the medical device is a core needle removably inserted into the lumen of a catheter assembly for placing the distal tip of the catheter assembly in the superior vena cava of the vascular system. Further, at least two of the multiple core fibers may be configured to undergo different types of strain in response to changes in the orientation of the multi-core fiber. In some implementations, each of the multiple reflective gratings alters its reflected light signal by applying a wavelength offset that depends on the strain experienced by the reflective grating.

[0029] Some embodiments of the present invention disclose a medical device comprising: a multi-core optical fiber having a plurality of core fibers, each of the plurality of 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 for determining the physical state of the multi-core optical fiber; and a console including 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 the execution of specific operations. These specific operations may include: providing a broadband incident optical signal to each of a plurality of reflection gratings distributed along the length of each of the plurality of core fibers of the multi-core optical fiber, the plurality of core fibers being spatially distributed to experience different degrees of strain; receiving optical signals of different spectral widths of broadband incident light reflected by each of the plurality of reflection gratings; and processing the reflected optical signals received from each of the plurality of reflection gratings associated with the plurality of core fibers to determine (i) the physical state of the multi-core optical fiber associated with the medical device including the multi-core optical fiber and (ii) the orientation of the multi-core optical fiber relative to a reference frame of the body.

[0030] Some implementations also include generating a display showing the physical state of the multi-core fiber based at least on the orientation determined during the processing of the reflected light. Alternatively, the display may be a two-dimensional representation of the physical state of the multi-core fiber according to the orientation determined during the processing of the reflected light.

[0031] In some embodiments, the physical state of the multi-core optical fiber associated with the medical device includes one or more of the length, shape, or form that the multi-core optical fiber currently possesses. In further embodiments, different types of strain include compression and tension.

[0032] In some instances, determining the orientation of the multi-core fiber relative to a body reference frame includes: establishing a body reference frame using a coordinate system; establishing an initial propulsion direction for the multi-core fiber along a first axis of the coordinate system based on the multi-core fiber entering the body at a known insertion site; associating an initial reflected light signal with the initial propulsion direction along the first axis of the coordinate system; detecting bending during propulsion of the multi-core fiber based on processing of the reflected light signal; and associating a reflected light signal corresponding to the bending during propulsion with a second propulsion direction along a second axis of the coordinate system, wherein the orientation is defined by (i) the initial reflected light signal associated with the initial propulsion direction along the first axis of the coordinate system and (ii) the reflected light signal corresponding to the bending during propulsion associated with the second propulsion direction along the second axis of the coordinate system. The medical device may include an elongated vascular system inserted into a patient's body. In some embodiments, the medical device is a core needle removably inserted into the lumen of a catheter assembly for positioning the distal tip of the catheter assembly in the superior vena cava of the vascular system. Further, at least two of the multiple core fibers may be configured to undergo different types of strain in response to changes in the orientation of the multi-core fiber. In some implementations, each of the multiple reflection gratings alters its reflected light signal by applying a wavelength offset that depends on the strain experienced by the reflection grating.

[0033] These and other features of the concepts provided herein will become more apparent to those skilled in the art, taking into account the accompanying drawings and the following description, which disclose specific embodiments of these concepts in greater detail. Attached Figure Description

[0034] Embodiments of the disclosed text are shown in the accompanying drawings by way of example rather than limitation, wherein the same reference numerals denote similar elements, and wherein:

[0035] Figure 1A This is an illustrative embodiment of a medical device monitoring system according to some implementation schemes, the medical device monitoring system including a medical device with optical shape sensing and fiber optic-based blood oxygen measurement capabilities;

[0036] Figure 1BThis is an optional illustrative embodiment of the medical device monitoring system 100 according to some implementation schemes;

[0037] Figure 2 It is based on some implementation plans, including Figure 1A An exemplary embodiment of the structure of a portion of the multi-core optical fiber within the core needle 120;

[0038] Figure 3A It is based on some implementation plans. Figure 1A The first exemplary implementation of the core needle supports both optical and telecommunication signaling;

[0039] Figure 3B It is based on some implementation plans. Figure 3A A cross-sectional view of the core needle;

[0040] Figure 4A It is based on some implementation plans. Figure 1B A second exemplary embodiment of the core needle;

[0041] Figure 4B It is based on some implementation plans. Figure 4A A cross-sectional view of the core needle;

[0042] Figure 5A This is a front view of a first illustrative embodiment of a conduit according to some implementation schemes, the conduit including integrated tubing, a diametrically arranged diametrically and a microlumen within the tubing and diaphragm;

[0043] Figure 5B It is based on some implementation plans. Figure 5A A perspective view of a first illustrative embodiment of a catheter, which includes a core fiber mounted within a microlumen;

[0044] Figures 6A-6B It is based on some implementation plans. Figure 1A-1B A flowchart illustrating the operational method for implementing optical 3D shape sensing in a medical device monitoring system;

[0045] Figure 7 It is based on some implementation plans. Figure 1B An exemplary implementation of a medical device monitoring system during catheter manipulation and patient insertion;

[0046] Figures 8A-8B It is a perspective view of a 3D duct image in a plane in a 3D Cartesian coordinate system according to some implementation schemes;

[0047] Figures 9A-9B The diagram illustrates the implementation of some schemes by Figure 1AA flowchart of the first implementation scheme for the logical execution operation of a medical device monitoring system;

[0048] Figure 10 It is based on some implementation plans. Figure 1A A second exemplary implementation of a medical device monitoring system during catheter manipulation and patient insertion; and

[0049] Figure 11A-11B The diagram illustrates the implementation of some schemes by Figure 1A The flowchart of the second implementation scheme for the logical execution operation of the medical device monitoring system. Detailed Implementation

[0050] 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.

[0051] 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.

[0052] The terms "proximal," "proximal portion," or "proximal portion" of a probe, as disclosed herein, include the portion of the probe intended to be close to the clinician when the probe is used on a patient. Similarly, the term "proximal length" of a probe, for example, includes the length of the probe intended to be close to the clinician when the probe is used on a patient. For instance, when the probe is used on a patient, the "proximal end" of the probe includes the end of the probe closest to the clinician. The proximal portion, proximal portion, or proximal length of a probe may include the proximal end of the probe; however, the proximal portion, proximal portion, or proximal length of a probe does not necessarily include the proximal end of the probe. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of a probe is not the distal portion or distal length of the probe.

[0053] For example, the term "distal," "distal portion," or "distal part" of a probe disclosed herein includes the portion of the probe intended to be close to or within the patient when the probe is used on a patient. Similarly, for example, the term "distal length" of a probe includes the length of the probe intended to be close to or within the patient when the probe is used on a patient. For example, when the probe is used on a patient, the term "distal end" of the probe includes the end of the probe that is close to or within the patient. The distal portion, distal part, or distal length of a probe may include the distal end of the probe; however, the distal portion, distal part, or distal length of a probe does not necessarily include the distal end of the probe. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of a probe is not the distal end portion or distal length of the probe.

[0054] 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 with data processing and / or storage capabilities. Embodiments of such circuitry can include, but are not limited to, hardware processors (e.g., microprocessors, one or more processor cores, digital signal processors, programmable gate arrays, microcontrollers, application-specific integrated circuits "ASICs", etc.), semiconductor memories, or combinations thereof.

[0055] Alternatively, the term "logic" may refer to or include software, such as one or more processes, one or more instances, application programming interfaces (APIs), subroutines, functions, applets, service programs, routines, source code, object code, shared libraries / dynamic link libraries (DLLs), or even one or more instructions. Software may be stored in any suitable type of non-transient storage medium or transient storage medium (e.g., electrical, optical, acoustic, or other forms of propagated signals, such as carrier waves, infrared signals, or digital signals). Embodiments of non-transient storage media may include, but are not limited to, programmable circuits; non-persistent memory, such as volatile memory (e.g., any type of random access memory "RAM"); or persistent memory, such as non-volatile memory (e.g., read-only memory "ROM", powered RAM, flash memory, phase-change memory, etc.), solid-state drives, hard disk drives, optical disk drives, or portable storage devices. As firmware, the logic may be stored in persistent storage.

[0056] refer to Figure 1AIllustrative embodiments of a medical device monitoring system are shown according to some implementations, the medical device monitoring system including a medical device with optical shape sensing and fiber-optic-based blood oxygenation measurement capabilities. As shown, system 100 typically includes a console 110 and a needle assembly 119 communicatively coupled to the console 110. For this embodiment, the needle assembly 119 includes an elongated probe (e.g., a needle) 120 at its distal end 122 and a console connector 133 at its proximal end 124, wherein the needle 120 is configured to be advanced within a patient's vascular system via or together with a catheter 195. The console connector 133 enables the needle assembly 119 to be operatively connected to the console 110 via an interconnect 145, the interconnect 145 including one or more optical fibers 147 (hereinafter referred to as "optical fiber(s)") and a conductive medium terminated by a single optical / electrical connector 146 (or terminated by a dual connector). Here, connector 146 is configured to engage (mate) with console connector 133 to allow light to propagate between console 110 and needle assembly 119 and electrical signals to propagate from needle 120 to console 110.

[0057] An exemplary implementation of console 110 includes processor 160, memory 165, display 170, and optical logic 180; however, it will be understood that console 110 may take one of various forms and may include additional components (e.g., power supply, ports, interfaces, etc.) that are not disclosed herein. An illustrative embodiment of console 110 is shown in U.S. Publication No. 2019 / 0237902, the entire contents of which are incorporated herein by reference. A processor 160 is included to control the functions of console 110 during operation, and processor 160 has access to memory 165 (e.g., non-volatile memory or non-transitory computer-readable medium). As shown, display 170 may be a liquid crystal diode (LCD) display integrated into console 110 and is used as a user interface to display information to clinicians, particularly during catheter placement procedures (e.g., cardiac catheterization). In another embodiment, display 170 may be separate from console 110. Although not shown, the user interface is configured to provide user control of console 110.

[0058] For both implementations, the content depicted by display 170 can vary depending on the mode in which the core 120 is configured to operate (optical, TLS, ECG, or another mode). In TLS mode, the content presented by 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 core 120, calculated from the characteristics of the reflected light signal 150 returning 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 the disclosed text, the reflected light signal 150 can relate to various discrete portions (e.g., specific spectral widths) of the broadband incident light 155 delivered from and originating from optical logic 180, as described below.

[0059] According to one embodiment of the published text, an activation control 126 included on the needle assembly 119 can be used to set the needle 120 to a desired operating mode, and the operability of the display 170 can be selectively altered by a clinician to aid in medical device placement. For example, based on the modality of the needle 120, the display 170 of the console 110 can be used for optical modality-based guidance during catheter advancement through the vasculature system or during TLS mode to determine the physical state of the needle 120 (e.g., length, form, shape, orientation, etc.). In one embodiment, information from multiple modalities, such as optical, TLS, or ECG, can be displayed simultaneously (e.g., displayed with at least partial temporal overlap).

[0060] Still referencing Figure 1A Optical logic 180 is configured to support the operability of the core assembly 119 and enable the return of information to console 110. This information can be used to determine the physical state associated with core 120 and monitored electrical signals, such as ECG signaling via telematics logic 181, which supports receiving and processing received electrical signals from core 120 (e.g., port, analog-to-digital conversion logic, etc.). The physical state of core 120 can be based on changes in the characteristics of the reflected optical signal 150 received from core 120 at console 110. Characteristics may include wavelength shifts caused by strain in certain regions of the core fiber integrated within or operating as the core 135 of the optical fiber, as shown below. As discussed herein, the optical fiber core 135 may include core fibers 1371-137. M (For a single core, M = 1; for multiple cores, M ≥ 2), where the core fiber is 1371-137. MThese can be collectively referred to as core fibers (one or more) 137. Unless otherwise stated or an alternative interpretation is required by this embodiment, the embodiments discussed herein will refer to multi-core optical fibers 135. Based on information associated with the reflected light signal 150, the console 110 can determine (by calculation or extrapolation of wavelength offset) the physical state of the core needle 120, and the physical state of the conduit 195 configured to receive the core needle 120.

[0061] According to one implementation scheme in the publicly available text, such as Figure 1A As shown, optical logic 180 may 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 optical fibers (one or more) 147 included in interconnect 145, which are optically connected to multi-core fiber cores 135 within a core pin 120. In one embodiment, the light source 182 is a tunable swept-frequency laser, but other suitable light sources besides lasers may also be used, including semi-coherent light sources, LED light sources, etc.

[0062] The optical receiver 184 is configured to: (i) receive the returned optical signal, namely, the reflected optical signal 150 received from a fiber-based reflective grating (sensor), which is fabricated within each core fiber of a multi-core optical fiber 135 deployed within a core pin 120; and (ii) convert the reflected optical signal 150 into reflected data (from a storage library 192), namely, data in the form of an electrical signal representing the reflected optical signal, which includes 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 optical fiber 135 and a reflected optical signal 152 provided by a sensor located in the peripheral core fibers of the multi-core optical fiber 135, as described below. Here, the optical receiver 184 may be implemented as a photodetector, such as a positive-intrinsic-negative "PIN" photodiode, an avalanche photodiode, etc.

[0063] As shown, both the light source 182 and the optical receiver 184 are operatively connected to a processor 160 that manages their operation. Furthermore, the optical receiver 184 is operatively coupled to provide reflection data (from the storage bank 192) to a memory 165 for storage and processing by reflection data classification logic 190. The reflection data classification logic 190 can be configured to: (i) identify which core fibers are associated with which of the received reflection data (from the storage bank 192); and (ii) segment the reflection data stored in the storage bank 192 (provided by reflected light signals 150 associated with similar regions or spectral widths of the core needle 120) into analysis groups. The reflection data for each analysis group is available to the shape sensing logic 194 for analysis.

[0064] According to one embodiment of the published text, shape sensing logic 194 is configured to compare the wavelength shift measured by sensors in each peripheral core fiber at the same measurement area (or the same spectral width) of the mandrel 120 with the wavelength shift at the central core fiber of the multi-core fiber 135, which is positioned along the central axis and operates as a bending neutral axis. Based on these analyses, shape sensing logic 194 can determine the shape taken by the core fiber in 3D space and can further determine the current physical state of the conduit 195 in 3D space for presentation on display 170.

[0065] According to one embodiment of the published text, shape sensing logic 194 can generate a representation of the current physical state of the mandrel 120 (and potentially catheter 195) based on heuristics or runtime analysis. For example, shape sensing logic 194 can be configured according to machine learning techniques to access a data memory (library) containing pre-stored data (e.g., images, etc.) relating to different regions of the mandrel 120 (or catheter 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 mandrel 120 (or catheter 195) can be represented. Alternatively, as another embodiment, the shape sensing logic 194 may be configured to determine, during runtime, changes in the physical state of each region of the multi-core fiber 135 based at least on: (i) the resultant wavelength shifts experienced by the different core fibers within the 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 central core fiber at the same cross-sectional area. It is contemplated that other processes and procedures may be performed to present appropriate changes in the physical state of the core needle 120 (and / or catheter 195) using the wavelength shifts measured by sensors along each core fiber within the multi-core fiber 135, particularly when the core needle 120 is positioned at the distal tip of the catheter 195, enabling guidance of the core needle 120 within the patient's vascular system and at its desired destination within the body.

[0066] The console 110 may further include telecommunications command logic 181, which is positioned to receive one or more electrical signals from the die 120. The die 120 is configured to support both optical and electrical connectivity. The telecommunications command logic 181 receives the electrical signals (e.g., ECG signals) from the die 120 via a conductive medium. The electrical signals may be processed by electrical signal logic 196, executed by the processor 160, to determine the ECG waveform for display.

[0067] Additionally, console 110 includes wave logic 198 configured to analyze at least a subset of wavelength offsets measured by sensors deployed in each core fiber 137. Specifically, wave logic 198 is configured to analyze wavelength offsets measured by sensors on the core fiber 137, where this corresponds to the analysis (or “tip wave analysis”) of wave motion at the distal tip of the needle 120. In some embodiments, wave logic 198 measures and analyzes wavelength offsets measured by sensors at the distal end of the core fiber 137. Tip wave analysis includes at least the correlation between detected motion at the distal tip of the needle 120 (or other medical device or instrument) and empirical knowledge, which includes previously detected motions (waves) and optionally other current measurements such as ECG signals. Empirical knowledge may include previously detected motions at various locations within the vascular system (e.g., SVC, inferior vena cava (IVC), right atrium, azygos vein, other vessels such as arteries and veins) under normal, healthy conditions and in the presence of defects (e.g., vasoconstriction, vasospasm, vasoocele, etc.). Therefore, tip undulation analysis can lead to confirmation of tip location and / or detection of defects affecting blood vessels.

[0068] It should be noted that wave logic 198 does not need to perform the same analysis as shape sensing logic 194. For example, shape sensing logic 194 determines the 3D shape of the core 120 by comparing the wavelength shift in the outer core fiber of the multi-core fiber with the central reference core fiber. Wave logic 198 can instead correlate the wavelength shift with previously measured wavelength shifts and optionally other current measurements, without distinguishing between the wavelength shifts of the outer core fiber and the central reference core fiber, because tip wave analysis does not need to consider orientation or shape in 3D space.

[0069] In some implementations, such as those for tip location confirmation, the analysis of the wave logic 198 can utilize electrical signals (e.g., ECG signals) measured by the signaling logic 181. For example, the wave logic 198 can compare the motion of a sub-part of the needle 120 (e.g., the distal tip) with electrical signals representing cardiac impulses (e.g., heartbeats). This comparison can reveal whether the distal tip is within the SVC or the right atrium based on the close correspondence between the motion and the rhythmic heartbeat.

[0070] In various implementations, displays and / or warnings can be generated based on fluctuation analysis. For example, fluctuation logic 198 can generate a graph illustrating the detected fluctuations compared to previously detected tip fluctuations and / or anatomical movements within the patient's body (such as the rhythmic beating of the heart and / or the expansion and contraction of the lungs). In one implementation, such a graph can include a dynamic visualization of the movement of a medical device based on detected fluctuations adjacent to a secondary medical device that has moved based on previously detected tip fluctuations. In some implementations, the position of a sub-part of the medical device can be obtained from shape sensing logic 194, and the dynamic visualization can be position-specific (e.g., such that previously detected fluctuations show the expected fluctuations of the current position of the sub-part). In alternative implementations, the dynamic visualization can illustrate a comparison of the dynamic movement of a sub-part with the dynamic movement of one or more sub-parts that have moved based on previously detected fluctuations affecting one or more defects in the blood vessels.

[0071] According to one embodiment of the published text, fluctuation logic 198 can determine, based on a trial-and-error approach or run-time analysis, whether movement of one or more sub-sections of the vascular needle 120 indicates the location of a specific sub-section of the vascular needle 120 or a defect affecting a blood vessel, and consequently, the location of the catheter 195. For example, fluctuation logic 198 can be configured, according to machine learning techniques, to access a data store (library) having pre-stored data (e.g., experiential knowledge of previously detected tip fluctuation data, etc.) relating to different regions (sub-sections) of the vascular needle 120. Specifically, such an embodiment may include processing of a machine learning model trained using experiential knowledge, wherein detected fluctuations are used as input to the trained model, and processing of the trained model results in determining the proximity of the detected fluctuations to one or more locations within the patient's vascular system and / or one or more defects affecting a blood vessel.

[0072] In some implementations, the fluctuation logic 198 may be configured to determine, during runtime, whether movement of one or more sub-sections of the core 120 (and catheter 195) indicates the location of a particular sub-section of the core 120 or affects a defect in the vessel based at least on: (i) a synthetic wavelength shift experienced by the core fibers 137 within the one or more sub-sections; and (ii) the correlation between these wavelength shifts generated by sensors positioned along different core fibers at the same cross-sectional area of ​​the core 120 (or catheter 195) and previously detected wavelength shifts generated by corresponding sensors in the core fibers at the same cross-sectional area. It is contemplated that other processes and procedures may be performed to provide appropriate movement in the distal tip of the core 120 and / or catheter 195 using the wavelength shifts measured by sensors along each core fiber 137.

[0073] See Figure 1B An alternative exemplary embodiment of a medical device monitoring system 100 is shown. Here, the medical device monitoring system 100 is characterized by a console 110 and a medical device 130 communicatively coupled to the console 110. In this embodiment, the medical device 130 corresponds to a catheter, characterized by an integrated tubing having two or more lumens extending between a proximal end 131 and a distal end 132 of the integrated tubing. The integrated tubing (sometimes referred to as “catheter tubing”) communicates with one or more extension legs 140 via a bifurcated bushing 142. An optically based catheter connector 144 may be included on the proximal end of at least one extension leg 140 to allow the catheter 130 to be operatively connected to the console 110 via an interconnect 145 or another suitable component. Here, the interconnect 145 may include a connector 146 that, when coupled to the optically based catheter connector 144, establishes an optical connection between one or more optical fibers 147 (hereinafter, “optical fiber(one or more)”) included as part of the interconnect 145 and core fibers 137 deployed 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 fiber(s) 147 to the core fiber 137 within the conduit 130. For example... Figure 1B The core fiber 137, as shown, deployed within the catheter 130 includes components deployed in... Figure 1A The core fiber 137 inside the core needle 120 has the same properties and performs the same function.

[0074] Optical logic 180 is configured to support the graphical representation of the conduit 130 (most notably, the integrated tubing of the conduit 130) based on the characteristics of the reflected light signal 150 received from the conduit 130. The characteristics may include wavelength shifts caused by strain in certain areas of the core fibers 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 the physical state of the conduit 130, particularly the integrated tubing or a portion thereof (such as the tip or distal end of the tubing), to read fluctuations (real-time movement) at the tip (or distal end).

[0075] More specifically, optical logic 180 includes a light source 182. The light source 182 is configured to transmit broadband incident light 155 for propagation over optical fibers (one or more) 147 included in interconnects 145, which are optically connected to a plurality of core fibers 137 within the conduit tubing. Here, an optical receiver 184 is configured to: (i) receive a returned optical signal, i.e., a reflected optical signal 150 received from an optical fiber-based reflective grating (sensor), which is fabricated within each of the core fibers 137 deployed within the conduit 130; and (ii) convert the reflected optical signal 150 into reflected data (from a storage library 192), i.e., data in the form of an electrical signal representing the reflected optical signal, including wavelength shifts caused by strain. The reflected optical signals 150 associated with different spectral widths include a reflected optical signal 151 provided by a sensor located in the central core fiber (reference) of the conduit 130 and a reflected optical signal 152 provided by a sensor located in the outer core fibers of the conduit 130, as described below.

[0076] As described above, shape sensing logic 194 is configured to compare the wavelength shift measured by sensors deployed in each outer core fiber at the same measurement area (or the same spectral width) of the catheter with the wavelength shift at the central core fiber positioned along the central axis and operating as a bending neutral axis. Based on these analyses, shape sensing logic 190 can determine the shape taken by the core fiber in 3D space and can further determine the current physical state of the catheter 130 in 3D space for presentation on display 170.

[0077] According to one embodiment of the published text, shape sensing logic 194 can generate a representation of the current physical state of conduit 130 (particularly integrated tubing) based on a trial-and-error method or runtime analysis. For example, shape sensing logic 194 can be configured, according to machine learning techniques, to access a data storage (library) containing pre-stored data (e.g., images, etc.) relating to different regions of conduit 130 in which core fibers 137 experience similar or identical wavelength shifts. Based on the pre-stored data, the current physical state of conduit 130 can be represented. Alternatively, as another embodiment, shape sensing logic 194 can be configured to determine, during runtime, changes in the physical state of each region of conduit 130 based at least on: (i) the composite wavelength shift experienced by core fibers 137; and (ii) the relationship between these wavelength shifts generated by sensors positioned along different outer core fibers at the same cross-sectional area of ​​conduit 130 and the wavelength shift generated by a sensor of the central core fiber at the same cross-sectional area. It is conceivable that other processes and procedures could be performed to utilize the wavelength shift measured by sensors along each core fiber 137 to present appropriate changes in the physical state of the conduit 130.

[0078] 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".

[0079] 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.

[0080] 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.

[0081] 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).

[0082] 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.

[0083] See Figure 3A According to some implementation schemes, Figure 1A A first exemplary embodiment of the core needle supports both optical and telecommunication communication. Here, the core needle 120 is characterized by a centrally located multi-core optical fiber 135, which includes a cladding 300 and corresponding plurality of inner cavities 3201-320.M Multiple core fibers 1371-137 M (M≥2; M=4). Although the multi-core fiber 135 is illustrated within four (4) core fibers 1371-1374, a greater number of core fibers 1371-137 can be deployed. M (M>4) to provide more detailed three-dimensional sensing of the physical state (e.g., shape, etc.) of the multi-core fiber 135 and the core needle 120 of the deployed fiber 135.

[0084] In this embodiment of the disclosed text, the multi-core optical fiber 135 is encapsulated within a concentric braided tube 310 located above a low-friction coefficient layer 335. The braided tube 310 may be characterized by a "mesh" construction, wherein the spacing between the intersecting conductive elements is selected based on the required rigidity of the core 120, as a larger spacing can provide less rigidity and thus provide a more flexible core 120.

[0085] According to the implementation scheme in the publicly available text, such as Figures 3A-3B As shown, core fibers 1371-1374 include (i) a central core fiber 1371 and (ii) a plurality of peripheral core fibers 1372-1374, which are held within cavities 3201-3204 formed in the cladding 300. According to one embodiment of the disclosed text, the diameter of one or more of the cavities 3201-3204 may be configured to be larger than the diameter of the core fibers 1371-1374. By avoiding direct physical contact between a large portion of the surface area of ​​the core fibers 1371-1374 and the wall surfaces of the cavities 3201-3204, the wavelength variation of the incident light caused by angular deviations in the multi-core fiber 135 is reduced, thereby minimizing the wavelength variation applied to the cavities 3201-3204. M The wall (not the core fiber 1371-137) M The influence of pressure and tension (on itself).

[0086] like Figures 3A-3B As further shown, core fibers 1371-1374 may include a central core fiber 1371 located within a first cavity 3201 formed along the first neutral axis 230 and multiple core fibers 1372-1374 located within cavities 3202-3204 (each formed in a different region of the cladding 300 radiating from the first neutral axis 230). Typically, core fibers 1372-1374 (excluding the central core fiber 1371) may be located in different regions within the cross-sectional region 305 of the cladding 300 to provide sufficient spacing to enable three-dimensional sensing of the multi-core fiber 135 based on wavelength changes of incident light propagating through the core fibers 1372-1374 and reflected back to the console for analysis.

[0087] For example, the cladding 300 is characterized by, for example, Figure 3B In the case of the circular cross-sectional region 305 shown, the core fibers 1372-1374 can be positioned substantially equidistant from each other along the perimeter of the cladding 300, for example, at the positions shown as "top" (12 o'clock), "lower left" (8 o'clock), and "lower right" (4 o'clock). Therefore, in general, the core fibers 1372-1374 can be located within different segments of the cross-sectional region 305. In the case where the cross-sectional region 305 of the cladding 300 has a distal tip 330 and is characterized by a polygonal cross-sectional shape (e.g., triangle, square, rectangle, pentagon, hexagon, octagon, etc.), the central fiber 1371 can be located at or near the center of the polygonal shape, while the remaining core fibers 1372-1374... M It can be located near the corner between the intersecting sides of a polygonal shape.

[0088] 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.

[0089] See Figure 4A According to some implementation schemes, Figure 1B A second exemplary embodiment of the core needle. Now refer to... Figure 4A , showed Figure 1B 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.

[0090] refer to Figures 4A-4B Operating as a conductive medium for the core 120 in the transmission of electrical signals (e.g., ECG signals) to the control console, the conductive tubing 400 can be exposed up to the tip 410 of the core 120. In this embodiment of the disclosed text, conductive epoxy 420 (e.g., a metal-based epoxy, such as silver epoxy) can be attached to the tip 410 and similarly engage with the end cap / connection point created at the proximal end 430 of the core 120. The cladding 300 and the conductive tubing 400 (which are concentrically positioned 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 encapsulating both the cladding 300 and the conductive tubing 400.

[0091] See Figure 5A The diagram shows a front view of a first illustrative embodiment of a conduit, comprising an integrated tubing, a diaphragm arranged along its diameter, and microcavities formed within the tubing and diaphragm. Here, the conduit 130 includes an integrated tubing, a diaphragm 510 arranged along its diameter, and a plurality of microcavities 5301-5304. In this embodiment, the microcavities are fabricated within the wall 500 of the integrated tubing and within the diaphragm 510 of the conduit 130. Specifically, the diaphragm 510 divides a single cavity formed by the inner surface 505 of the wall 500 of the conduit 130 into a plurality of cavities, namely two cavities 540 and 545 as shown. Here, the first cavity 540 is formed between a first arcuate portion 535 forming the inner surface 505 of the wall 500 of the conduit 130 and a first outer surface 555 of the diaphragm 510 extending longitudinally within the conduit 130. The second inner lumen 545 is formed between the second arcuate portion 565 of the inner surface 505 of the wall 500 forming the conduit 130 and the second outer surface 560 of the diaphragm 510.

[0092] According to one embodiment of the invention, the two lumens 540 and 545 have approximately the same volume. However, the diaphragm 510 does not need to divide the tubing into two equal lumens. For example, instead of extending vertically (12 o'clock to 6 o'clock) from a forward-facing cross-sectional view of the tubing, the diaphragm 510 may 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 conduit 130 will have a different volume.

[0093] 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 555 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.

[0094] According to one implementation scheme in the publicly available text, such as Figure 5A As shown, microcavities 5302-5304 are positioned according to a “top left” (10 o’clock), “top right” (2 o’clock), and “bottom” (6 o’clock) layout from a forward-facing cross-sectional view. Of course, microcavities 5302-5304 can be positioned differently, as long as they are spatially separated along the circumference 520 of the conduit 130 to ensure more robust collection of reflected light signals from the outer core fibers 5702-5704 during installation. For example, two or more microcavities (e.g., microcavities 5302 and 5304) can be positioned in different quadrants along the circumference 520 of the conduit wall 500.

[0095] See Figure 5B According to some implementation schemes, Figure 5A A perspective view of a first illustrative embodiment of a catheter comprising a core fiber mounted within a microlumen. According to one embodiment of the disclosed text, the size of a second plurality of microlumens 5302-5304 is determined to hold the corresponding outer core fiber 5702-5704, wherein the diameter of each of the second plurality of microlumens 5302-5304 can be determined to be just larger than the diameter of the outer core fiber 5702-5704. For example, the dimensional difference between the diameter of a single core fiber and the diameter of any one of the microlumens 5301-5304 can range from 0.001 micrometers (μm) to 1000 μm. As a result, the cross-sectional area of ​​the outer core fiber 5702-5704 will be smaller than the cross-sectional area of ​​the corresponding microlumens 5302-5304. The “larger” microlumen (e.g., microlumen 5302) can better separate the external strain applied to the outer core fiber 5702 from the strain applied directly to the catheter 130 itself. Similarly, the size of the first microcavity 5301 can be set to hold the central core fiber 5701, wherein the diameter of the first microcavity 5301 can be set to be just larger than the diameter of the central core fiber 5701.

[0096] As an alternative embodiment of the disclosed text, the diameter of one or more of the microcavities 5301-5304 is determined to have a diameter exceeding that of the corresponding one or more core fibers 5701-5704. However, the size of at least one of the microcavities 5301-5304 is determined to permanently hold its corresponding core fiber (e.g., the core fiber is held such that there is no gap between its side surface and the inner wall surface of its corresponding microcavity). As yet another alternative embodiment of the disclosed text, the size of all the microcavities 5301-5304 is determined to have a single diameter in order to permanently hold the core fibers 5701-5704.

[0097] See Figures 6A-6B According to some implementation schemes, it is shown that by Figure 1A-1B A flowchart illustrates an operational method for implementing an optical 3D shape sensing within a medical device monitoring system. Here, the catheter includes at least one septum spanning the diameter of the tubing wall and extending longitudinally to divide the tubing wall. A first microlumen is fabricated in the middle portion of the septum, wherein the first microlumen is coaxial with the central axis of the catheter tubing. The first microlumen is configured to hold a central core fiber. Two or more microlumens, in addition to the first microlumen, are positioned at different locations circumferentially spaced along the wall of the catheter tubing. For example, two or more of a second plurality of microlumens may be positioned in different quadrants along the periphery of the catheter wall.

[0098] Furthermore, each core fiber includes multiple sensors spatially distributed along its length, at least between the proximal and distal ends of the conduit tubing. This sensor array is distributed to position the sensors at different regions of the core fiber, enabling distributed strain measurements across the entire length or selected portions of the conduit tubing. These distributed measurements can be transmitted via reflected light of varying spectral widths (e.g., specific wavelengths or wavelength ranges), which undergo certain wavelength shifts based on the type and extent of strain.

[0099] According to one implementation scheme in the publicly available text, such as Figure 6AAs shown, for each core fiber, broadband incident light is provided to propagate through the 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.

[0100] See now Figure 6B During operation, multiple reflected light signals originate from the conduit (e.g., ...). Figure 1B 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).

[0101] 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).

[0102] refer to Figure 7 According to some implementation schemes, Figure 1BAn exemplary implementation of a medical device monitoring system during catheter manipulation and patient insertion is provided. Here, catheter 130 typically includes an integrated tubing having a proximal portion 720 typically held outside the patient 700 and a distal portion 730 typically residing within the patient's vascular system after placement. The (integrated) tubing of catheter 130 can be advanced to a desired location within the patient's vascular system, such as with the distal (or tip) 735 of the tubing approaching the patient's heart, for example, in the lower third (1 / 3) portion of the superior vena cava (“SVC”). In some implementations, various devices can be positioned at the distal end 735 of catheter 130 to measure blood pressure in a cardiac chamber and blood vessel, view the interior of the blood vessel, etc. In alternative implementations, for example, using… Figure 1A An embodiment of the core assembly and catheter 195, such an instrument can be positioned at the distal end of the core 120.

[0103] During advancement through the patient's vascular system, the catheter tubing of catheter 130 receives broadband incident light 155 from console 110 via optical fibers (one or more) 147 within interconnect 145, wherein the incident light 155 propagates along the core fibers of the multi-core optical fibers 135 within the catheter tubing of catheter 130. According to one embodiment of the disclosed text, a connector 146 of interconnect 145 that terminates the optical fibers (one or more) 147 can be coupled to an optically based catheter connector 144, which can be configured to terminate the core fibers 137 deployed within catheter 130. Such coupling optically connects the core fibers 137 of catheter 130 to the optical fibers (one or more) 147 within interconnect 145. Optical connectivity is required to propagate the incident light 155 to the core fibers 137 and to return the reflected light signal 150 to optical logic 180 within console 110 via interconnect 145. As described in detail below, the physical state of catheter 130 can be determined based on analysis of the wavelength shift of the reflected light signal 150.

[0104] refer to Figure 8A The diagram illustrates a perspective view of a 3D conduit image in a plane within a 3D Cartesian coordinate system, according to some implementation schemes. Specifically, plane 800 shows a Cartesian coordinate system in three-dimensional space consisting of ordered triplet lines (axis lines, commonly referred to as the x-axis, y-axis, and z-axis), where points within plane 800 are represented by values ​​along each axis as (x, y, z), commonly referred to as "coordinates." The axes originate from a common point, commonly referred to as the "origin," which has coordinates (0, 0, 0) within plane 800.

[0105] like Figure 8AAs shown, multiple 3D catheter images are 3D representations of the physical state of a catheter (i.e., catheter 120) propelled through the vascular system of a patient's body 8021-802. i As discussed above, the 3D representation 8021-802 is calculated from the characteristics of the reflected light signal using shape sensing logic. i However, the characteristics calculated from the reflected light signal 150 and the subsequent 3D representation 8021-802... i What is clearly lacking is guidance on the orientation of the catheter relative to the patient's body.

[0106] Understanding the catheter's orientation relative to the patient's body is important for generating and presenting a 2D display of the shape of the catheter (and / or catheter), because most (if not all) displays used in catheter tracking systems are 2D displays, such as display 170. Therefore, without an indication of the catheter's orientation relative to the patient's body, a 2D display of the catheter (e.g., display 170) that is anatomically correct relative to the patient's body reference frame cannot be presented correctly.

[0107] To further explain this issue, Figure 8A Multiple 3D representations 8021-802 show the physical state of a catheter with various orientations propelling through the patient's vascular system within a plane 800. i 3D refers to 8021-802. i Each of the reflected light signals received can indicate only the shape, such as the curvature of the catheter, without indicating the direction of the curvature relative to a reference frame. Therefore, in order to generate and present a 2D display of the catheter relative to a reference frame of the patient's body, the orientation of the catheter must be determined according to the patient's body reference frame.

[0108] Now for reference Figure 8B According to some implementations, a perspective view of a 3D duct image in plane 810 of a 3D Cartesian coordinate system is shown. Figure 8B It shows the determination Figure 8A 3D representation 8021-802 i The first step in an implementation plan of this orientation. (As regarding...) Figures 9A-9BAs discussed in further detail in the implementation scheme, the percutaneous insertion site ("insertion site") of the needle (and catheter, collectively referred to as the "needle") can be known (e.g., on the patient's arm distal to the elbow joint) and the initial direction of the needle's advancement relative to the patient's body is known (e.g., towards the clavicle). Therefore, a reference frame for the patient's body can be established via console logic based on a patient-related coordinate system (e.g., an abstract x, y coordinate system). Thus, the initial direction of the needle's advancement can be established along the positive y-axis of the x, y coordinate system relative to the patient's reference frame. As an illustrative example, Figure 10 An exemplary implementation of a medical device monitoring system is depicted, showing an established reference frame 1020 for the patient, which is mirrored by an established reference frame 1022 on a display 170, wherein each reference frame utilizes an x, y coordinate system.

[0109] Refer again Figure 8B By limiting the initial advance direction of the core needle to the positive y-axis, the reference frame establishment logic 196 can record and establish the correlation between the received initial reflected light and the positive y-axis. This correlation can be stored by the reference frame establishment logic 196 and used to define the advance direction of the core needle, as discussed below. The term "initial reflected light" can refer to the portion of the received reflected light corresponding to the indicated path of the core needle traveling in a straight or substantially straight direction. For example, again referencing... Figure 10 The initial reflected light can correspond to the reflected light received simultaneously with the advancement of the catheter through segment 1002 of the patient 1000. Therefore, based on the received reflected light and the constraint of the initial advancement of the catheter in the positive direction along the y-axis, a 2D depiction of the catheter advancing through the patient's vascular system from the insertion site toward the patient's clavicle can be displayed on a 2D monitor.

[0110] Continuing with this embodiment, as the core needle is advanced toward the clavicle, it eventually begins to bend toward the patient's chest cavity (i.e., toward the center of the patient's body). Figure 8B Several scenarios are illustrated where the initial direction of the needle advance is known, but the direction in which the needle is bending is also known. In other words, even if the initial direction of the needle advance is known, once the needle begins to bend in the body, the received reflected light signal only provides an indication of the bending angle, not the direction of the bend relative to the patient's reference frame.

[0111] Refer again Figure 10 A bend may occur during the advance of the core needle through section 1004. Now return to the reference. Figure 8BWhen the bending of the core needle is detected by the shape sensing logic 194, the reference frame establishment logic 196 establishes the correlation between the received reflected light and the positive direction along the x-axis. This is done based on the knowledge that the core needle is anatomically constrained to bend toward the center of the patient's chest, which is in the positive direction along the x-axis according to the established patient reference frame.

[0112] Therefore, after detecting the bending of the needle, reference frame establishment logic 196 establishes the orientation of the needle, and thus the orientation of the catheter. By establishing the correlation between the initial reflected light and the positive direction along the y-axis and the correlation between the reflected light corresponding to the bending of the needle, reference frame establishment logic 196 can generate and present a 2D display based on the patient's body reference frame, showing the shape representation of the catheter during its advancement through the patient's vascular system (with correct anatomical orientation). As the needle continues its advancement, shape sensing logic 194, in conjunction with reference frame establishment logic 196, can generate a 2D display of the catheter by comparing the received reflected light with the orientation of the needle, defined by (i) the initial reflected light signal associated with the positive direction along the y-axis of the patient's reference frame and (ii) the reflected light signal associated with the bending during advancement associated with the positive direction along the x-axis of the patient's reference frame.

[0113] Now for reference Figures 9A-9B According to some implementation schemes, it is shown that by Figure 1A The flowchart of the first implementation scheme for the logical execution operation of the medical device monitoring system. Figures 9A-9B Each box shown represents an operation performed in method 900 (detecting the orientation of a catheter disposed within the patient's vascular system based on received reflected light signals). It is assumed that prior to the start of method 900, a catheter with a core disposed therein has been inserted into the patient's vascular system at a known percutaneous insertion site (e.g., in the patient's arm distal to the elbow). Specifically, it is assumed that the core comprises a multi-core optical fiber and is coupled to a console configured to provide broadband incident light to the core, such as... Figure 1A The console 110 and the needle tube 120.

[0114] Therefore, method 900 begins when broadband incident light is received by and propagates along the multi-core fiber of the mandrel. As discussed above, the broadband incident light is reflected by one or more gratings (sensors) of the multi-core fiber, such that the reflected light signal may include a wavelength shift associated with the strain experienced by each sensor. The console receives the reflected optical signal (reflected light signal) from the gratings fabricated within each core fiber of the multi-core fiber (which is deployed within the mandrel) (box 902).

[0115] The reflected light signal is then converted into reflected data, which is an electrical signal representing the wavelength shift in each core fiber caused by strain on the core fibers during the advancement of the mandrel through the patient's vascular system (box 904). An analysis is then performed to compare the wavelength shift of the peripheral core fibers with the wavelength shift of the central core fiber operating as a curved neutral axis to determine the shape adopted by the core fibers in 3D space (i.e., the shape of the mandrel and catheter) (box 906).

[0116] After performing analysis to determine the 3D shape of the catheter, a 2D display is generated and rendered using an x, y coordinate system to show a 2D representation of the catheter's shape as the catheter is advanced through the patient's vascular system (box 908). The 2D display is rendered such that the initial advancement of the catheter is shown along the positive y-axis. As described above, the display, for example... Figure 1A The display's x, y coordinate system corresponds to a reference system matched with the patient's body reference system. Therefore, the 2D display of the catheter during its initial advancement matches the anatomical positioning of the catheter during its initial advancement within the patient's body.

[0117] Now for reference Figure 9B Reflected optical signals (light signals) continue to be received from the multi-core optical fiber, providing a continuous indication of the shape of the mandrel, corresponding to the advancement of the catheter within the patient's vascular system. Analysis of the received reflected light signals is performed to further determine the shape the mandrel and catheter have adopted in 3D shape, thereby continuing to monitor their advancement (box 910). While continuously receiving reflected light signals and determining the 3D shape of the catheter during the initial advancement of the catheter, it is determined whether the reflection data derived from the reflected light signals indicates that the mandrel has bent during advancement (box 912). When the determination is that the mandrel has not bent (no in box 912), the generation and display of a 2D display continues, in which the advancement of the catheter is shown in the positive direction along the y-axis of the reference frame of the display (e.g., display 170) (box 914).

[0118] When it is determined that the needle has begun to bend (yes at box 912), the orientation of the needle is established using a 2D display reference frame to match the patient's body reference frame (box 916). Specifically, the bending direction indicated by the reflected light signal is set to be associated with the positive direction along the x-axis of the 2D display. Based on the initial advance direction of the needle being set to be associated with the positive direction along the y-axis and the bending direction being set to be associated with the positive direction along the x-axis, the orientation of the needle relative to the 2D display reference frame is established. Thus, the console logic has established the orientation of the needle (and catheter) such that the advancement of the catheter on the 2D display is shown in an anatomically correct manner relative to the patient's body reference frame. The established orientation can be stored as the correlation between a reflected light signal (e.g., a specific wavelength offset) and a specific direction along a specific axis in the console, for example, along with Figure 1A-1B The reflection data 192, or alternatively, the reflection data in a separate data store of console 110 (not shown).

[0119] Continuous generation and presentation of 2D displays are used to illustrate catheter advancement based on the orientation of the established core needle relative to a 2D display frame that matches the patient's body frame of reference, using received optical signals (light signals). (Box 918)

[0120] refer to Figure 10 According to some implementation schemes, Figure 1A A second exemplary implementation of a medical device monitoring system during catheter (including a needle) manipulation and patient insertion. As described above, Figure 10 A series of theoretical segments (segments 1002, 1004, 1006, 1008) of the catheter 120 are shown, each segment indicating a transition from a first shape to a second shape of the catheter 120 (and catheter 195). As further illustrated, catheter 195 typically includes a proximal portion 1011 that is generally held outside the patient 1000 and a distal portion 1012 that is generally retained within the patient's vascular system after placement. The catheter 120 is used to assist in positioning the distal tip 1014 of catheter 195 in a desired location within the patient's vascular system. In one embodiment, the desired location of the distal tip 1014 of catheter 195 is close to the patient's heart, such as in the lower third (1 / 3) portion of the superior vena cava (SVC) for this embodiment. Of course, the catheter 120 can be used to place the distal tip 1014 of catheter in other locations.

[0121] During propulsion, the mandrel 120 receives broadband light 155 from the console 110 via an interconnect 145, which includes a connector 146 for coupling to a console connector 144 of the mandrel assembly 118. Reflected light 150 from sensors (reflection gratings) within each core fiber of the multi-core fiber 137 is returned from the mandrel 120 via the interconnect 145 for processing by the console 110. The physical state of the mandrel 120 can be determined based on analysis of the wavelength shift of the reflected light 150. For example, strain caused by bending of the mandrel 120 and the resulting angular change in 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 changes (shifts) in the wavelength of the reflected light from sensors located on each core fiber within the multi-core fiber 137, such as… Figure 2 As shown. Based on this wavelength offset, the shape sensing analysis logic 194 within the console 110 can determine the physical state (e.g., shape, etc.) of the core needle 120, or, when the conduit 195 mirrors the core needle 120, also determine the physical state of the conduit 195.

[0122] As briefly discussed above, Figure 10 Two reference systems are shown: a patient body reference system 1016, which includes a coordinate system 1016 relative to the patient's body; and a reference system of the display 170, which mirrors the orientation of the patient body reference system and includes a coordinate system 1018 relative to the boundaries of the display 170. Therefore, see... Figures 9A-9B In the implementation of method 900, the orientation of the patient's body reference frame (including coordinate system 1016) is equivalent to that of the display 170 reference frame (including coordinate system 1018). Therefore, by determining the orientation of the core needle 120 and the catheter 195, the logic of the console 110 can generate a 2D representation of the shape of the catheter 195 (as the catheter 195 is advanced anatomically appropriately within the vascular system of the patient's body).

[0123] Figure 11A-11B According to some implementation schemes, it is shown that by Figure 1A The flowchart of the second implementation scheme for the logical execution operation of the medical device monitoring system. Figure 11A-11B Each box shown represents an operation performed in method 1100 (detecting the orientation of a catheter positioned within the patient's vascular system based on the received reflected light signal). The assumptions discussed above regarding method 900 also apply to method 1100.

[0124] Therefore, method 1100 begins when broadband incident light is received by the multi-core fiber of the mandrel and propagates along the multi-core fiber. As described above, the broadband incident light is reflected by one or more gratings (sensors) in the multi-core fiber, such that the reflected light signal may include a wavelength shift related to the strain experienced by each sensor. The console receives the reflected optical signal (reflected light signal) (box 1102) from the gratings fabricated within each core fiber of the multi-core fiber (which is deployed within the mandrel).

[0125] The reflected light signal is then converted into reflected data, which is an electrical signal representing the wavelength shift in each core fiber caused by strain on the core fibers during the advancement of the mandrel through the patient's vascular system (box 1104). An analysis is then performed to compare the wavelength shift of the peripheral core fibers with the wavelength shift of the central core fiber operating as a curved neutral axis to determine the shape of the core fibers employed in 3D space (i.e., the shape of the mandrel and catheter) (box 1106).

[0126] After performing the analysis to determine the 3D shape of the catheter, when the catheter is used as described above... Figures 9A-9B The discussion concerns the generation and rendering of a 2D display (box 1108) as the catheter is advanced through the patient's vascular system relative to the patient's reference x, y coordinate system. The 2D display is rendered such that the initial direction of catheter advancement is shown along the path described above regarding... Figures 9A-9B The positive direction of the y-axis is being discussed.

[0127] Now for reference Figure 11B The reflected optical signals (light signals) continue to be received from the multi-core optical fiber, providing a continuous indication of the needle shape, corresponding to the advancement of the catheter within the patient's vascular system. A heuristic or runtime analysis is performed on the reflected light signals to associate the 3D shape of the needle with multiple pre-stored images (box 1110). In one such embodiment, the current 3D shape of the needle is fed to a machine learning model, which is processed to influence the correlation between the current 3D shape and the pre-stored 3D images. The processing result of the machine learning model indicates a correlation value between the current 3D shape and one or more pre-stored images, each image having a known orientation relative to the patient's body. Thus, when the correlation value exceeds a threshold, it is determined that the current 3D shape has a known orientation corresponding to the pre-stored image. As those skilled in the art will understand, the machine learning model will be pre-trained using pre-stored images of the 3D shapes of the needle / catheter, each with a known orientation relative to the patient's reference frame. Furthermore, the machine learning algorithm used can be any known machine learning algorithm, especially, but not limited to, supervised learning algorithms such as logistic regression and / or neural networks.

[0128] Therefore, based on the results of trial and error or runtime analysis, the orientation of the needle is established relative to a reference frame of the patient's body, mirrored by the 2D reference frame (box 1112). Thus, the console has determined the orientation of the needle (and catheter) such that the advancement of the catheter is displayed in a 2D display in an anatomically appropriate manner relative to the reference frame of the patient's body. The 2D display is continuously generated and presented so that the advancement of the catheter is illustrated using the established orientation of the needle relative to a 2D display reference frame that matches the reference frame of the patient's body, based on received optical signals (light signals) (box 1114).

[0129] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. 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: A broadband incident light signal is provided to each of a plurality of reflective gratings distributed along the length of each of a plurality of core fibers in a multi-core optical fiber, the plurality of core fibers being spatially distributed to experience different degrees of strain; Receive optical signals with different spectral widths of the broadband incident light reflected by each of the plurality of reflection gratings; and The reflected light signal received from each of the plurality of reflective gratings associated with the plurality of core fibers is processed to determine: (i) the physical state of the multi-core fiber in relation to a medical device including the multi-core fiber; and (ii) the orientation of the multi-core fiber relative to a reference frame of the patient's body, wherein determining the orientation of the multi-core fiber relative to the reference frame of the body includes: Establish the reference frame for the body using a coordinate system; Based on the multi-core optical fiber that has entered the body at a known insertion site, an initial propulsion direction is established for the multi-core optical fiber along a first axis of the coordinate system; The initial reflected light signal is associated with the initial propulsion direction along the first axis of the coordinate system; Based on the processing of the reflected light signal, the bending during the advancement of the multi-core optical fiber is detected; and The reflected light signal corresponding to the bend in the propulsion is associated with a second propulsion direction along a second axis of the coordinate system, wherein the orientation is defined by: (i) the initial reflected light signal associated with the initial propulsion direction along the first axis of the coordinate system; and (ii) the reflected light signal corresponding to the bend in the propulsion associated with the second propulsion direction along the second axis of the coordinate system.

2. The non-transitory computer-readable medium according to claim 1, characterized in that, Further includes: Based at least on the orientation determined during the processing of the reflected light, a display showing the physical state of the multi-core optical fiber is generated.

3. The non-transitory computer-readable medium according to claim 2, characterized in that, The display is a two-dimensional representation of the physical state of the multi-core optical fiber, based on the orientation determined during the processing of the reflected light.

4. The non-transitory computer-readable medium according to claim 1, characterized in that, The physical state of the multi-core optical fiber associated with the medical device includes one or more of the length, shape, or form that the multi-core optical fiber currently has.

5. The non-transitory computer-readable medium according to claim 1, characterized in that, The different degrees of strain include compression and tension.

6. The non-transitory computer-readable medium according to claim 1, characterized in that, The medical device includes an elongated vascular system that is inserted into the patient's body.

7. The non-transitory computer-readable medium according to claim 6, characterized in that, The medical device is a core needle that is removably inserted into the lumen of a catheter assembly for placing the distal tip of the catheter assembly in the superior vena cava of the vascular system.

8. The non-transitory computer-readable medium according to claim 1, characterized in that, At least two of the plurality of core fibers undergo different degrees of strain in response to orientation changes in the multi-core optical fiber.

9. The non-transitory computer-readable medium according to claim 1, characterized in that, Each of the plurality of reflective gratings alters its reflected light signal by applying a wavelength offset, the wavelength offset depending on the strain experienced by the reflective grating.

10. A medical device system for placing a medical device into a patient's body, characterized in that, The medical device system includes: A medical device comprising a multi-core optical fiber having multiple core fibers, each of the multiple 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 for determining the physical state of the multi-core optical fiber; and A console includes 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: Provide broadband incident optical signals to the multi-core optical fiber. Receive optical signals with different spectral widths of the broadband incident light reflected from each of the plurality of sensors. The reflected light signals associated with the plurality of core fibers are processed to determine: (i) the physical state of the multi-core fiber in relation to a medical device including the multi-core fiber; and (ii) the orientation of the multi-core fiber relative to a reference frame of the body, wherein determining the orientation of the multi-core fiber relative to the reference frame of the body includes: Establish the reference frame for the body using a coordinate system; Based on the multi-core optical fiber that has entered the body at a known insertion site, an initial propulsion direction is established for the multi-core optical fiber along a first axis of the coordinate system; The initial reflected light signal is associated with the initial propulsion direction along the first axis of the coordinate system; Based on the processing of the reflected light signal, the bending during the advancement of the multi-core optical fiber is detected; and The reflected light signal corresponding to the bend in the propulsion is associated with a second propulsion direction along a second axis of the coordinate system, wherein the orientation is defined by: (i) the initial reflected light signal associated with the initial propulsion direction along the first axis of the coordinate system; and (ii) the reflected light signal corresponding to the bend in the propulsion associated with the second propulsion direction along the second axis of the coordinate system.

11. The medical device system according to claim 10, characterized in that, Further includes: Based at least on the orientation determined during the processing of the reflected light, a display showing the physical state of the multi-core optical fiber is generated.

12. The medical device system according to claim 11, characterized in that, The display is a two-dimensional representation of the physical state of the multi-core optical fiber, based on the orientation determined during the processing of the reflected light.

13. The medical device system according to claim 10, characterized in that, The physical state of the multi-core optical fiber associated with the medical device includes one or more of the length, shape, or form that the multi-core optical fiber currently has.

14. The medical device system according to claim 10, characterized in that, The medical device includes an elongated vascular system that is inserted into the patient's body.

15. The medical device system according to claim 14, characterized in that, The medical device is a core needle that is removably inserted into the lumen of a catheter assembly for placing the distal tip of the catheter assembly in the superior vena cava of the vascular system.

16. The medical device system according to claim 10, characterized in that, At least two of the plurality of core fibers undergo different types of strain in response to orientation changes in the multi-core optical fiber.

17. The medical device system according to claim 16, characterized in that, The different types of strain include compression and tension.

18. The medical device system according to claim 10, characterized in that, Each of the plurality of sensors alters its reflected light signal by applying a wavelength shift, the wavelength shift depending on the strain experienced by the sensor.

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