Dislocation detection system

Abstract

Disclosed herein are systems, apparatuses, and methods relating to detecting malposition of a medical device within a vessel of a patient, such as an odd vein. A medical device may include a multi-core optical fiber including a plurality of core fibers, where each of the plurality of core fibers includes a plurality of sensors configured to reflect a light signal based on received incident light and to vary a characteristic of the reflected light signal for use in determining a physical state of the multi-core optical fiber. The system may include a console of a non-transitory computer-readable medium having stored logic that, when executed, causes operations to provide a broadband incident light signal to the multi-core fiber, receive a reflected light signal, process the reflected light signal, and determine whether the medical device has entered the odd vein of the patient based on the reflected light signal.

Description

[0001] Case information

[0002] This application is a divisional application of the invention patent application filed on June 24, 2021, with application number 202110706498.3 and invention title "Misalignment Detection System".

[0003] priority

[0004] This application claims priority to U.S. Provisional Application No. 63 / 044,911, filed June 26, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0005] This application relates to the field of medical devices, and more specifically to misalignment detection systems. Background Technology

[0006] 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.

[0007] Recently, electromagnetic tracking systems involving a mandrel 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 mandrel (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.

[0008] 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.

[0009] This paper discloses a system and method for determining, based on one or more signals from a medical device, whether a medical device inserted into a patient has deviated from its target propulsion path and whether it has entered the patient's blood vessels. Summary of the Invention

[0010] In summary, some embodiments disclosed herein relate to systems, apparatus, and methods for 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 and for determining misalignment of the medical device within a patient's blood vessels (such as the azygos vein). In some embodiments, the system is a fiber optic shape sensing system and method configured to provide confirmation of tip position or to transmit / interpret information as electrical signals. Some embodiments combine fiber optic shape sensing functionality with one or more of vascular electrocardiography (ECG) monitoring, impedance / conduction sensing, and blood flow orientation detection. While the embodiments herein relate to misalignment into the azygos vein, the invention described herein is not limited thereto. It should be understood that the invention described herein can be used to detect misalignment of a medical device in any number of blood vessels and locations in a patient and is not intended specifically for misalignment into the azygos vein.

[0011] More specifically, in some embodiments, the medical device includes a multi-core optical fiber, each core fiber 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 those regions 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 a 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.

[0012] 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 2-5B and Figure 7A-12 As shown.

[0013] 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.

[0014] In some embodiments where the core includes a multi-core optical fiber, each core fiber utilizes multiple sensors, and each sensor is configured to reflect incident light of 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 convey the type and degree of strain on that core fiber at those locations on the core occupied by the sensor. The sensors are spatially distributed at different locations on the core fibers between the proximal and distal ends of the core, allowing shape sensing of the core 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 core, while simultaneously through the same component (the core).

[0015] 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.

[0016] According to one embodiment of the published text, each sensor can operate as a reflective grating, such as a fiber Bragg grating (FBG), which is 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, thereby providing distributed measurements, as described above.

[0017] During operation, multiple light reflections (also known 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.

[0018] 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 spatially located at different 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).

[0019] Implementations of the disclosed text may include a combination of one or more methods to determine when an realized subject (e.g., catheter, guidewire, and / or catheter needle) has deviated from its target trajectory (e.g., into the right atrium) and instead entered an undesirable location (e.g., the azygos vein). Some implementations of the disclosed text involve distal tip position detection using fiber optic shape sensing, such that deviations of the realized subject into the negative Z-plane (dorsal movement of the realized subject) can be detected and identified using analysis of reflected light through a multi-core fiber, as discussed below. For example, the use of fiber optic shape sensing can be used to analyze reflected light by comparing it to a predetermined anatomical angle, deviation from an identified reference plane (with identified anterior / posterior orientation), and / or deviation from a predetermined anatomical frame.

[0020] Other embodiments of the disclosed text involve using fiber optic shape sensing to detect undulations in the realized subject. For example, a decrease in undulations in the realized subject can be used to identify a propulsion deviation of the realized subject from the SVC into the azygos vein. Additionally, intravascular ECG monitoring can be combined with any one or both of the fiber optic shape sensing methods mentioned above to detect propulsion deviations of the realized subject into the azygos vein when the P-wave amplitude detected by intravascular ECG is slightly reduced, or even when the realized subject is propulsed toward the sinoatrial (SA) node. Alternatively, impedance / conduction sensing can be combined with any one or two of the fiber optic shape sensing methods and optionally with intravascular ECG monitoring to detect propulsion deviations of the realized subject into the azygos vein. For example, smaller diameter vessels are characterized by varying impedance / conduction when the realized subject deviates into the azygos vein.

[0021] In other implementations, the direction of blood flow can be used in combination with any of the fiber optic shape sensing methods, intravascular ECG monitoring, and / or impedance / conduction sensing mentioned above. For example, when the realized body deviates from entering the azygos vein, the blood flow changes from being consistent with the advance of the realized body to being opposite to the advance of the realized body, which can be detected using a pulse oximeter and / or blood flow Doppler. For example, detection using a pulse oximeter includes measuring and analyzing the oxygen level in the blood as the realized body advances through the vascular system. Specifically, the analysis of oxygen levels can vary with the vascularity, such that when the distal tip of the realized body is in the heart, deviation of the distal tip of the realized body into the azygos vein can be detected when the measured oxygen level decreases. Specifically, the oxygen level can decrease as the distal tip of the realized body advances from a larger vascular vessel (SVC) to a smaller vascular vessel (azygos vein).

[0022] Some embodiments of this document disclose a medical device system for detecting misalignment of a medical device within a patient's blood vessel (e.g., the azygos vein). The system includes a medical device and a control console. The medical device includes a multi-core optical fiber having multiple core fibers, each of which includes multiple sensors distributed along the longitudinal length of the respective core fiber. Each of the multiple sensors is configured to: (i) reflect optical signals of different spectral widths based on received incident light; and (ii) modify the characteristics of the reflected optical signals to determine the physical state of the multi-core optical fiber. The control 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: providing a broadband incident optical signal to the multi-core optical fiber; receiving reflected optical signals of different spectral widths of broadband incident light reflected by each of the multiple sensors; processing the reflected optical signals associated with the multiple core fibers; and determining, based on the reflected optical signals, whether the medical device has entered the patient's azygos vein.

[0023] In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the shape of the medical device indicated by reflected light signals. In some embodiments, the shape of the medical device indicated by the reflected light signals is used as input to a machine learning process configured to process the input and provide a result indicating a confidence level regarding whether the shape of the medical device indicates entry into the patient's azygos vein. In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the results of a trial-and-error approach performed on the shape of the medical device indicated by reflected light signals. In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the amount of fluctuation in the medical device indicated by reflected light signals.

[0024] In certain embodiments, the fluctuation amount of the medical device is the fluctuation amount at the distal tip of the medical device. In some embodiments, determining whether the medical device has entered the azygos vein is based on the shape of the medical device indicated by reflected light signals and electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system. In some embodiments, determining whether the medical device has entered the azygos vein is based on the shape of the medical device indicated by reflected light signals and impedance sensing of the medical device propelling the medical device through the patient's vascular system. In some embodiments, determining whether the medical device has entered the azygos vein is based on: (i) the shape of the medical device indicated by reflected light signals; (ii) electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system; and (iii) impedance sensing of the medical device propelling the medical device through the patient's vascular system.

[0025] In some embodiments, determining whether a medical device has entered the azygos vein is based on the detection of the shape of the medical device, indicated by reflected light signals, and the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned. In some embodiments, determining whether a medical device has entered the azygos vein is based on the shape of the medical device, indicated by reflected light signals, and one or more of the following: (i) electrocardiogram (ECG) monitoring propelling the medical device through the patient's vascular system, (ii) impedance sensing propelling the medical device through the patient's vascular system, or (iii) detection of the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned.

[0026] In some implementations, determining whether a medical device has entered the azygos vein is based on: (i) the shape of the medical device indicated by reflected light signals; (ii) electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system; (iii) impedance sensing of the medical device propelling the medical device through the patient's vascular system; and (iv) detection of the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned.

[0027] In certain embodiments, different types of strain include compression and tension. In other embodiments, the medical device comprises an elongated shape and is inserted into a vascular system within 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. In other embodiments, at least two of the plurality of core fibers undergo different types of strain in response to a change in the orientation of the multi-core fiber. In other embodiments, each of the plurality of sensors is a reflective grating, wherein each reflective grating alters its reflected light signal by applying a wavelength shift depending on the strain experienced by the reflective grating.

[0028] A further embodiment relates to a method for placing a medical device into a patient's body, the method comprising providing a broadband incident optical signal to a multi-core optical fiber included within the medical device, wherein the multi-core optical fiber comprises a plurality of core fibers, each of the plurality of core fibers comprising a plurality of reflective grating fibers distributed along the longitudinal length of the respective core fiber, and each of the plurality of reflective gratings is configured to: (i) reflect optical signals of different spectral widths based on the received incident light; and (ii) modify the characteristics of the reflected optical signals to determine the physical state of the multi-core optical fiber. The method further includes receiving reflected optical signals of different spectral widths of broadband incident light reflected by each of the plurality of reflective gratings, processing the reflected optical signals associated with the plurality of core fibers, and determining, based on the reflected optical signals, whether the medical device has entered the patient's azygos vein.

[0029] In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the shape of the medical device indicated by reflected light signals. In some embodiments, the shape of the medical device indicated by the reflected light signals is used as input to a machine learning process configured to process the input and provide a result indicating a confidence level regarding whether the shape of the medical device indicates entry into the patient's azygos vein. In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the results of a trial-and-error approach performed on the shape of the medical device indicated by reflected light signals. In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the amount of fluctuation in the medical device indicated by reflected light signals.

[0030] In certain embodiments, the fluctuation amount of the medical device is the fluctuation amount at the distal tip of the medical device. In some embodiments, determining whether the medical device has entered the azygos vein is based on the shape of the medical device indicated by reflected light signals and electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system. In some embodiments, determining whether the medical device has entered the azygos vein is based on the shape of the medical device indicated by reflected light signals and impedance sensing of the medical device propelling the medical device through the patient's vascular system. In some embodiments, determining whether the medical device has entered the azygos vein is based on: (i) the shape of the medical device indicated by reflected light signals; (ii) electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system; and (iii) impedance sensing of the medical device propelling the medical device through the patient's vascular system.

[0031] In some embodiments, determining whether a medical device has entered the azygos vein is based on the detection of the shape of the medical device, indicated by reflected light signals, and the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned. In some embodiments, determining whether a medical device has entered the azygos vein is based on the shape of the medical device, indicated by reflected light signals, and one or more of the following: (i) electrocardiogram (ECG) monitoring propelling the medical device through the patient's vascular system; (ii) impedance sensing propelling the medical device through the patient's vascular system; or (iii) detection of the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned.

[0032] In some implementations, determining whether a medical device has entered the azygos vein is based on: (i) the shape of the medical device indicated by reflected light signals; (ii) electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system; (iii) impedance sensing of the medical device propelling the medical device through the patient's vascular system; and (iv) detection of the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned.

[0033] In certain embodiments, different types of strain include compression and tension. In other embodiments, the medical device comprises an elongated shape and is inserted into a vascular system within 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. In some embodiments, at least two of the multiple core fibers undergo different types of strain in response to a change in the orientation of the multi-core optical fiber. In some embodiments, each of the multiple sensors is a reflective grating, wherein each reflective grating alters its reflected light signal by applying a wavelength shift depending on the strain experienced by the reflective grating.

[0034] Some embodiments disclose a non-transitory computer-readable medium on which logic is stored, which causes operation when executed by one or more processors. The operation includes providing a broadband incident optical signal to a multi-core optical fiber included within a medical device, wherein the multi-core optical fiber comprises a plurality of core fibers, each of the plurality of core fibers comprising a plurality of reflective grating fibers distributed along the longitudinal length of the respective core fiber, and each of the plurality of reflective gratings is configured to: (i) reflect optical signals of different spectral widths based on the received incident light; and (ii) modify the characteristics of the reflected optical signals to determine the physical state of the multi-core optical fiber. The operation also includes receiving reflected optical signals of different spectral widths of broadband incident light reflected by each of the plurality of reflective gratings, processing the reflected optical signals associated with the plurality of core fibers, and determining, based on the reflected optical signals, whether the medical device has entered the patient's azygos vein.

[0035] In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the shape of the medical device indicated by reflected light signals. In some embodiments, the shape of the medical device indicated by the reflected light signals is used as input to a machine learning process configured to process the input and provide a result indicating a confidence level regarding whether the shape of the medical device indicates entry into the patient's azygos vein. In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the results of a trial-and-error approach performed on the shape of the medical device indicated by reflected light signals. In some embodiments, the determination operation determines whether a medical device has entered the azygos vein based on the amount of fluctuation in the medical device indicated by reflected light signals.

[0036] In certain embodiments, the fluctuation amount of the medical device is the fluctuation amount at the distal tip of the medical device. In some embodiments, determining whether the medical device has entered the azygos vein is based on the shape of the medical device indicated by reflected light signals and electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system. In some embodiments, determining whether the medical device has entered the azygos vein is based on the shape of the medical device indicated by reflected light signals and impedance sensing of the medical device propelling the medical device through the patient's vascular system. In some embodiments, determining whether the medical device has entered the azygos vein is based on: (i) the shape of the medical device indicated by reflected light signals; (ii) electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system; and (iii) impedance sensing of the medical device propelling the medical device through the patient's vascular system.

[0037] In some embodiments, determining whether a medical device has entered the azygos vein is based on the detection of the shape of the medical device, indicated by reflected light signals, and the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned. In some embodiments, determining whether a medical device has entered the azygos vein is based on the shape of the medical device, indicated by reflected light signals, and one or more of the following: (i) electrocardiogram (ECG) monitoring propelling the medical device through the patient's vascular system, (ii) impedance sensing propelling the medical device through the patient's vascular system, or (iii) detection of the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned.

[0038] In some implementations, determining whether a medical device has entered the azygos vein is based on: (i) the shape of the medical device indicated by reflected light signals; (ii) electrocardiogram (ECG) monitoring of the medical device propelling the medical device through the patient's vascular system; (iii) impedance sensing of the medical device propelling the medical device through the patient's vascular system; and (iv) detection of the direction of blood flow within a portion of the patient's vascular system in which the medical device is disposed.

[0039] In certain embodiments, different types of strain include compression and tension. In other embodiments, the medical device comprises an elongated shape and is inserted into a vascular system within 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. In some embodiments, at least two of the multiple core fibers undergo different types of strain in response to changes in the orientation of the multi-core optical fiber. In some embodiments, each of the multiple sensors is a reflective grating, wherein each reflective grating alters its reflected light signal by applying a wavelength shift depending on the strain experienced by the reflective grating.

[0040] 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

[0041] 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:

[0042] 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;

[0043] Figure 1B This is an optional illustrative embodiment of the medical device monitoring system 100 according to some implementation schemes;

[0044] Figure 2 It is included in some implementation plans. Figure 1A An exemplary embodiment of the structure of a portion of the multi-core optical fiber within the core needle 120;

[0045] 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;

[0046] Figure 3B It is based on some implementation plans. Figure 3A A cross-sectional view of the core needle;

[0047] Figure 4A It is based on some implementation plans. Figure 1B A second exemplary embodiment of the core needle;

[0048] Figure 4B It is based on some implementation plans. Figure 4A A cross-sectional view of the core needle;

[0049] 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;

[0050] 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;

[0051] 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;

[0052] Figure 7A It is based on some implementation plans. Figure 1A-1B An exemplary implementation of a medical device monitoring system during catheter manipulation and patient insertion;

[0053] Figure 7B It is based on some implementation plans. Figure 7A Detailed view of the catheter being advanced into the patient's right atrium in the superior vena cava (SVC);

[0054] Figure 8 This is the first illustration of a catheter inserted into the right atrium of the patient's heart through the patient's vascular system, according to some implementation schemes.

[0055] Figure 9 This is a second illustration of a catheter inserted through the patient's vascular system toward the right atrium of the patient's heart, according to some implementation schemes;

[0056] Figures 10A-10C It is a diagram depicting an electrode configuration for acquiring intravascular ECG data according to some implementation schemes;

[0057] Figure 11 This is an illustration of an exemplary peripherally inserted central catheter according to some implementation schemes; and

[0058] Figure 12 This is a diagram of a second embodiment of a system utilizing a peripheral insertion center combined with two electrode pads, based on some implementation schemes. Detailed Implementation

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] Alternatively, or in alternatives, 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, logic may be stored in persistent storage.

[0065] refer to Figure 1A Illustrative 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 oxygen 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.

[0066] 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.

[0067] 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.

[0068] 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).

[0069] Still referencing Figure 1AOptical 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 fiber, as shown below. As discussed herein, the 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. M These 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 (through 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.

[0070] 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.

[0071] The optical receiver 184 is configured to: (i) receive a returned optical signal, namely a reflected optical signal 150 received from a fiber-based reflective grating (sensor), the grating being 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.

[0072] 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 storage 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 storage 192); and (ii) segment the reflection data stored in storage 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.

[0073] 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.

[0074] 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, shape sensing logic 194 can 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 can 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.

[0075] 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.

[0076] 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 motion (wave motion) and optionally other current measurements such as ECG signals. Empirical knowledge may include previously detected motion 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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 the 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 the blood vessel.

[0081] In some embodiments, 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 in 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 in the same cross-sectional area. It is contemplated that other processes and procedures may be performed to utilize the wavelength shifts measured by sensors along each core fiber 137 to provide appropriate movement in the distal tip of the core 120 and / or catheter 195.

[0082] See Figure 1B An alternative exemplary embodiment of a medical device monitoring system 100 is illustrated. 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 enable 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, which, when coupled to the optically based catheter connector 144, establishes an optical connection between one or more optical fibers 147 (hereinafter, “optical fibers (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.

[0083] 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. These characteristics may include wavelength shifts caused by strain in certain areas of the core fiber 137 integrated within (or along) the wall of the integrated tubing, which can be used (through calculation or extrapolation of the wavelength shift) to determine 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).

[0084] 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 from a sensor located in the central core fiber (reference) of the conduit 130 and a reflected optical signal 152 provided from a sensor located in the outer core fibers of the conduit 130, as described below.

[0085] 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.

[0086] 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 memory (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, the 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.

[0087] 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".

[0088] 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.

[0089] 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 ƒ1…ƒ N This indicates that the adjacent spectral widths reflected by adjacent gratings do not overlap.

[0090] 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).

[0091] 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 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, having 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.

[0092] 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.

[0093] 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.

[0094] 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).

[0095] like Figures 3A-3B As further shown, the 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, the 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 the wavelength variation of incident light propagating through the core fibers 1372-1374 and reflected back to the console for analysis.

[0096] 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.

[0097] 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.

[0098] 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). In the implementation of 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.

[0099] 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.

[0100] 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.

[0101] 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 can extend horizontally (3 o'clock to 9 o'clock), diagonally (1 o'clock to 7 o'clock; 10 o'clock to 4 o'clock), or at an angle (2 o'clock to 10 o'clock). In the latter configuration, each of the lumens 540 and 545 of the conduit 130 will have a different volume.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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 retain 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.

[0107] Furthermore, each core fiber includes multiple sensors spatially distributed along its length between at least 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.

[0108] 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.

[0109] 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).

[0110] 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).

[0111] Now for reference Figure 7A According to some implementation schemes, Figure 1AAn exemplary implementation of a medical device monitoring system during catheter manipulation and patient insertion is provided. Here, catheter 195 typically comprises an integrated tubing having a proximal portion 720 that is typically held outside the patient 700 and a distal portion 730 that typically resides within the patient's vascular system after placement. A needle 120 can be advanced through catheter 195 to a desired location within the patient's vascular system, such that the distal end (or tip) 735 of needle 120 (and therefore the distal end of catheter 195) is close to the patient's heart, for example, in the lower third (1 / 3) portion of the superior vena cava (SVC). For this implementation, various devices can be placed at the distal end of needle 120 and / or catheter 195 to measure blood pressure in a cardiac chamber and vessel, examine the interior of the vessel, etc.

[0112] During advancement through the patient's vascular system, the needle 120 receives broadband incident light 155 from the console 110 via optical fibers (one or more) 147 within an interconnect 145, wherein the incident light 155 propagates to the core fiber 137 of the needle 120. According to one embodiment of the disclosed text, a connector 146 of the interconnect 145, which 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 fiber 137 deployed within the needle 120. Such coupling optically connects the core fiber 137 of the needle 120 to the optical fibers (one or more) 147 within the interconnect 145. Optical connectivity is required to propagate the incident light 155 to the core fiber 137 and to return a reflected light signal 150 to the console 110 via the interconnect 145 using optical logic 180. As described in detail below, the physical state of the needle 120 and the catheter 195 can be determined based on analysis of the wavelength shift of the reflected light signal 150.

[0113] See Figure 7B According to some implementation schemes, Figure 7A A detailed view of the catheter being advanced into the patient's right atrium through the superior vena cava (SVC). Figure 7B The diagram shows... Figure 7A Part of the catheter, it provides a detailed perspective view of the vascular system and the anatomical structures of the heart. Specifically, as the catheter 120 approaches the right atrium 746 via the SVC 742, it can be advanced into the right atrium 746 or deviate from the afferent vein 743. The catheter 120 is typically used to locate specific points in the vascular system where the catheter can be used to administer medical procedures or medications; this point can be referred to as the "target site" (e.g., [missing information]). Figure 8 (As shown). Several methods for detecting deviation of the 120 needle from the azygos vein 743 are disclosed below.

[0114] In some embodiments, shape sensing logic 194 is configured to determine the shape of the core fiber in 3D space as the core 120 is advanced through the patient's vascular system, and may further determine the current physical state of the core 120 (and therefore the catheter 195) in 3D space for presentation on display 170. According to one embodiment of the disclosed text, shape sensing logic 194 may generate a representation of the current physical state of the catheter 195 based on the physical state of the core 120 using a trial-and-error method or runtime analysis. For example, shape sensing logic 196 may be configured, according to machine learning techniques, to access a data memory (library) having pre-stored data (e.g., images, etc.) relating to different regions of the catheter 195 in which the core fiber 137 experiences similar or identical wavelength shifts.

[0115] In some implementations, as the catheter 120 is advanced into the superior vena cava (SVC) and approaches the right atrium, a subset of images included in pre-stored data (or a separate set of images stored in the azygos vein detection data 199) can depict the specific placement of the catheter 120. Specifically, the subset of images may include both images in which the advancement of the catheter 120 follows a desired or anticipated path through the SVC and enters the right atrium (e.g., to a predetermined target site) and images in which the advancement of the catheter 120 deviates from the desired or anticipated path and enters the azygos vein. Furthermore, after generating the physical state of the catheter 120, it can be compared using a trial-and-error method or runtime analysis with a subset of images depicting advancement along desired (expected) and undesired (unexpected) paths to determine whether the catheter 120 has deviated from entering the azygos vein. For example, analysis performed by the azygos vein detection logic 196 can result in a determination indicating whether the catheter 120 and / or catheter 195 has entered the azygos vein.

[0116] See Figure 8A first illustration of a ventricle 120 being advanced through the patient's vascular system toward the right atrium of the heart, according to some embodiments, is shown. As shown, the ventricle 120 is being advanced through the SVC 742 toward a target site 800 within the right atrium 746, but has deviated from the intended path and entered the azygos vein 743. In one embodiment, reflected light generated by a sensor (reflective grating) indicates such a bend as the ventricle 120 is advanced toward the azygos vein 743. Azygos vein detection logic 198 obtains the physical state of the generated ventricle 120 from shape sensing logic 194 and determines, through trial and / or run analysis, that the physical state of the generated ventricle indicates entry into the azygos vein 743. As mentioned above, such determination can be based at least in part on a comparison with a set of pre-stored images using a machine learning strategy (and optionally in conjunction with an image recognition algorithm). For example, a trained machine learning model can provide an indication that the ventricle 120 has entered the azygos vein 743 with a specific confidence level. It should be understood that the machine learning model will be pre-trained using pre-stored images of: (i) a catheter correctly directed toward the right atrium 746; and (ii) a catheter deviating from the afferent azygos vein 743.

[0117] Alternatively, the azygos vein detection logic 198 can analyze reflected light relative to the pulsation of the needle 120 during its advancement to determine whether the needle 120 has deviated from the azygos vein 743. For example, known or anticipated pulsations can be pre-stored as part of the azygos vein detection data 199 for various regions of the human vascular system. These known pulsations can be compared with the current pulsation of the needle 120 calculated by the azygos vein detection logic 198 based on reflected light indicating the movement of the needle 120. The difference in pulsation of the needle 120 between the SVC 742 and the azygos vein 743 may be the result of one or more factors, including more turbulent blood flow in the SVC 742, a larger diameter of the SVC 742, differences in pulsatility between the SVC 742 and the azygos vein 743, and differences in internal volume between the SVC 742 and the azygos vein 743. The amount or rate of fluctuation of the needle 120 can be a combination of the movement of the needle 120 (particularly the distal tip) in any direction within a specific part of the vascular system through which the needle 120 is currently traveling.

[0118] Specifically and again refer to Figure 8The SVC 742 is shown having a diameter (D1) 802, and the azygos vein 743 is shown having a diameter (D2) 804, wherein the D2 804 of the azygos vein 743 is smaller than the D1 802 of the SVC 742. Therefore, the larger diameter of the SVC 742 allows the core needle 120 to have a higher rate of fluctuation within a specific propulsion stretch than the smaller diameter of the azygos vein 743; that is, the core needle 120 is more restricted in its physical movement when deviating from the azygos vein 743.

[0119] Additionally, higher volatility may be caused by myocardial contraction of the heart and activation of heart valves adjacent to the blood pathway. Specifically, these contractions and activations disrupt stable blood flow in the SVC 742, where stable blood flow is more widely observed in the rest of the venous vascular system. In regions immediately adjacent to the heart (e.g., the SVC), when the ventricle 120 is present in this region of the vascular system, vascular properties are unable to flatten and filter out these disturbances to stabilize blood flow, resulting in observable movement (volatiles) within the ventricle 120. Therefore, the azygos vein detection logic 198 can detect deviations from the azygos vein 198 based on a lower volatility caused at least partially by the aforementioned contractions and activations, where the volatility is indicated in reflected light.

[0120] In other embodiments, the direction of blood flow can be used as an indication that the catheter needle 120 has deviated from the afferent azygos vein 743. Specifically, as Figure 8 As shown, the direction of blood flow in SVC 742 is indicated by arrow 806 (i.e., consistent with the direction of advancement of the needle 120), and the direction of blood flow in the azygos vein 743 is indicated by arrow 808 (i.e., opposite to the direction of advancement of the needle 120). Therefore, using data obtained via pulse oximetry and / or flow Doppler (typically in addition to one or more embodiments discussed herein), directional flow detection logic 199 can determine that the needle 120 has deviated from the azygos vein 743. Directional flow detection logic 199 can be a sub-logic module of azygos vein detection logic 198. For example, techniques implementing pulse oximetry and / or optical Doppler (e.g., Doppler ultrasound) can be integrated into the needle 120 and provide the azygos vein detection logic 198 with readings of blood oxygen levels and blood flow velocity, which helps the azygos vein detection logic 198 determine whether the distal tip of the implemented body has deviated from the azygos vein.

[0121] In some implementations, in addition to the previously discussed fiber optic shape sensing functionality, the core 120 and / or catheter 195 may be operable to perform intravascular ECG monitoring. As described above, the console 110 may include telecommunications command logic 181, which, when configured to receive electrical signals at, for example, the distal tip, is positioned to receive one or more electrical signals from the core 120 and / or catheter 195. Furthermore, the core 120 is operable to support both optical and electrical connectivity. The telecommunications command logic 181 receives electrical signals (e.g., ECG signals) from the core 120 via a conductive medium 144. The electrical signals may be processed by electrical signal analysis logic 196, executed by the processor 160, to determine an ECG waveform for display.

[0122] See Figure 9 A second illustration, based on some implementation schemes, shows a catheter inserted through the patient's vascular system toward the right atrium of the patient's heart. As known and Figure 9 As shown, the SA node 900 generates electrical impulses that control the sinus rhythm of the heart. For example, these impulses are detectable via electrodes, for instance, coupled to the distal tip of the sinoatrial (SA) node 120. When the sinoatrial (SA) node 120 deviates from the afferent azygos vein 743, even as the sinoatrial (SA) node 120 is advanced toward the SA node 900, the amplitude of the P wave in the detected intravascular ECG is slightly reduced.

[0123] Now for reference Figures 10A-10C The illustration shows an electrode configuration provided for acquiring intravascular ECG data, according to some embodiments. See details. Figure 10A The illustration depicts a single-lead configuration with a reference electrode 1006 and a second electrode 1008. The reference electrode 1006 is attached to the skin on the patient's right arm, for example, and the second electrode 1008 is coupled to a catheter 120 or a tubular needle 195. It should be noted that the attachment of the reference electrode 1006 to the skin on the right arm is for illustrative purposes only; other configurations are possible depending on the required ECG type. This configuration enables ECG data to be obtained from the SVC 1002 and the inferior vena cava 1004.

[0124] refer to Figure 10BThe illustration depicts an improved 3-lead configuration utilizing four electrodes for monitoring and guidance. In this configuration, three electrodes correspond to standard ECG electrodes: right arm (RA) 1010, left arm (LA) 1012, and left leg (LL) 1014 (not shown to scale), with the left leg electrode 1014 used as a reference. A fourth electrode 1016 is attached to a needle 120 or catheter 195. In this configuration, the console 110 and electrical signal analysis logic 196 can perform two functions simultaneously or concurrently (at least partially overlapping in time): the three standard electrodes (1010, 1012, 1014) perform cardiac monitoring, while the fourth electrode 1016 allows recording of ECG at the tip of the needle 120 or catheter 195. In addition... Figure 10A In addition to the configuration of electrodes 1006 and 1008 discussed in the text, Figure 10C An illustration is provided depicting a telemetry configuration with a single ground lead 1018. This configuration can be used to configure remote ECG transmission via a telemetry system.

[0125] Now for reference Figure 11 The illustration shows an exemplary peripherally inserted central catheter according to some embodiments. Device 1100 includes or is configured as a central venous catheter (CVC), such as a peripherally inserted central catheter (PICC or PICC line), wherein detector 1102 is positioned at or near the distal end 1104 of device 1100. Additionally, device 1100 is configured with multi-fiber optical fibers that receive broadband incident light and reflect optical signals (light signals) to a control console, as described above. In some embodiments, the multi-fiber optical fibers may be integrated into the interior of device 1100 (e.g., when device 1100 is a guidewire or needle). In other embodiments, the multi-fiber optical fibers may be integrated into the wall of device 1100 (e.g., when device 1100 is a catheter).

[0126] The device 1100 itself includes an elongated body 1106 made of a material that allows delivery of the device 1100 into a patient's cavity organ (or through an access path of another body part) and subsequently withdrawal from the patient without harming the patient. For example, the elongated body 1106 may include silicone or one or more other polycarbonates to prevent the device 1100 from “adhering” to the patient's vascular system during or after insertion. In various embodiments of the device 1100, at least one lumen 1108 is defined within the elongated body 1106, and multiple lumens 1108 may be defined. In other embodiments (such as lead-line embodiments), the device 1100 will not have lumens passing through it.

[0127] Detector 1102 includes a pair of detection electrodes 1114, 1116 positioned between a pair of excitation electrodes 1110, 1112. Detector 1102 is configured to generate an electric field and also acquire multiple conduction measurements within the electric field as detector 1102 is advanced through the patient's vascular system, each of the multiple conduction measurements indicating the position of detector 1102 within the patient's vascular system when detector 1102 is positioned therein.

[0128] See now Figure 12 A diagram of a second embodiment of a system utilizing a peripherally inserted central conduit and two electrode pads is shown, according to some implementations. Figure 12 In the illustrated embodiment, an electric field is generated by electrodes coupled to or positioned on pads 1202, 1204. In such an embodiment, as detector 1206 moves with needle 1205 through the patient's vascular system, conduction changes can be obtained using detector 1206, which includes detection electrodes 1208, 1210, similar to detection electrodes 1114, 1116.

[0129] In such an implementation, when the distal excitation electrode 110 and the proximal excitation electrode 112 are activated, the electric field is detectable by the detection electrodes 1208 and 1210 of the detector 1206. As the catheter 1205 is advanced through the patient's vascular system from smaller diameter / cross-sectional area vessels to larger vessels and finally to the heart, a gradual change (increase) in conduction can be identified, as well as the expected pulsatile characteristics of voltage changes due to the pumping of the heart can be identified, indicating the delivery of the distal end of the catheter 1205 to the right atrium.

[0130] Specifically, in embodiments where pads 1202 and 1204, which themselves can be used as magnetic poles or excitation electrodes, can be positioned on pads 1202 and 1204, due to the use of, Figure 12 The pads 1202 and 1204 shown provide two magnetic poles, and the core needle 1205 does not need to include an excitation electrode positioned thereon (e.g., Figure 11 The excitation electrodes 1110, 1112. In some embodiments, one or more wires (not shown) may be connected to pads 1202, 1204 to transfer current from the ECG / EKG device (and / or console 110), thereby generating an electric field detectable by the needle 1205.

[0131] like Figure 12As shown, pads 1202 and 1034 are each positioned on the patient's torso. While other locations may be used, the illustrated embodiment includes pad placement in which pad 1202 is positioned adjacent to a vein (through which the catheter 1205 will pass on its way to the right atrium), and pad 1204 is positioned adjacent to the right ventricle or right atrium of the heart (or typically positioned away from pad 1202, such as on the patient's opposite arm, in or near the patient's neck, or elsewhere on the torso).

[0132] In an embodiment where two pads 1202 and 1204 are magnetic poles and generate an electric field, when the detection portion of the needle 1205 is outside the field, the conduction is typically high and the voltage is very low, and when the detection portion of the needle 1205 is moved back into the field, the conduction decreases significantly while the voltage increases.

[0133] 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: Provide a broadband incident optical signal to a multi-core optical fiber included in a medical device, wherein the multi-core optical fiber comprises a plurality of core fibers, each of the plurality of core fibers comprising a plurality of reflective grating fibers distributed along the longitudinal length of the respective core fiber, and each of the plurality of reflective gratings is configured to: (i) reflect optical signals of different spectral widths based on the received incident light; (ii) altering the characteristics of the reflected light signal to determine the physical state of the multi-core optical fiber; Receive reflected light signals of different spectral widths of the broadband incident light reflected by each of the plurality of reflection gratings; Process the reflected light signals associated with the plurality of core fibers; and Based on the reflected light signal, it is determined whether the medical device has entered the patient's blood vessel.

2. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel is the patient's azygos vein, and it is determined whether the medical device has entered the azygos vein based on the shape of the medical device indicated by the reflected light signal.

3. The non-transitory computer-readable medium according to claim 2, characterized in that, The shape of the medical device, indicated by the reflected light signal, is used as input to a machine learning machine configured to process the input and provide a result indicating a confidence level regarding whether the shape of the medical device indicates access to the patient's azygos vein.

4. The non-transitory computer-readable medium according to claim 2, characterized in that, Determining whether the medical device has entered the azygos vein is based on the results of a trial-and-error method performed on the shape of the medical device indicated by the reflected light signal.

5. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel is the patient's azygos vein, and the determination of whether the medical device has entered the azygos vein is based on the amount of fluctuation of the medical device indicated by the reflected light signal.

6. The non-transitory computer-readable medium according to claim 5, characterized in that, The fluctuation amount of the medical device is the fluctuation amount at the distal tip of the medical device.

7. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel is the azygos vein of the patient, and the determination of whether the medical device has entered the azygos vein is based on the shape of the medical device indicated by the reflected light signal and electrocardiogram monitoring that propels the medical device through the patient's vascular system.

8. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel is the azygos vein of the patient, and it is determined whether the medical device has entered the azygos vein based on the shape of the medical device indicated by the reflected light signal and impedance sensing that propels the medical device through the patient's vascular system.

9. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel is the azygos vein of the patient, and the determination of whether the medical device has entered the azygos vein is based on: (i) the shape of the medical device indicated by the reflected light signal; and (ii) electrocardiogram monitoring propelling the medical device through the patient's vascular system. (iii) Advance the medical device through impedance sensing of the patient's vascular system.

10. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel is the azygos vein of the patient, and it is determined whether the medical device has entered the azygos vein based on the shape of the medical device indicated by the reflected light signal and the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned.

11. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel is the azygos vein of the patient, and it is determined whether the medical device has entered the azygos vein based on the shape of the medical device indicated by the reflected light signal and one or more of the following: (i) electrocardiographic monitoring of the medical device propelling the medical device through the patient's vascular system; (ii) impedance sensing of the medical device propelling the medical device through the patient's vascular system; or (iii) detection of the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned.

12. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel is the azygos vein of the patient, and the determination of whether the medical device has entered the azygos vein is based on: (i) the shape of the medical device indicated by the reflected light signal; (ii) electrocardiographic monitoring of the medical device propelling the medical device through the patient's vascular system; (iii) impedance sensing of the medical device propelling the medical device through the patient's vascular system; and (iv) detection of the direction of blood flow within a portion of the patient's vascular system in which the medical device is currently positioned.

13. The non-transitory computer-readable medium according to claim 1, characterized in that, Different types of strain include compression and tension.

14. The non-transitory computer-readable medium according to claim 1, characterized in that, The vessel in question is the azygos vein of the patient.

15. The non-transitory computer-readable medium according to claim 1, 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 non-transitory computer-readable medium according to claim 1, 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 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.

18. A medical device system for detecting misalignment of a medical device within a patient's blood vessels, characterized in that, The medical device system includes: The medical device, configured for propulsion through the patient's blood vessels; 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: The medical device receives one or more signals representing one or more parameters, the one or more parameters indicating the position of the distal tip of the medical device within the patient's blood vessel. Process the one or more signals to determine the location of the distal tip, and Based on the one or more signals, it is determined whether the medical device has deviated from the target propulsion path and has entered the patient's blood vessel.

19. The medical device system according to claim 18, characterized in that, The vessel in question is the azygos vein.

20. The medical device system according to claim 18, characterized in that, The medical device includes a multi-core optical fiber having multiple core fibers, each of the multiple core fibers including multiple sensors distributed along the longitudinal length of the respective core fiber, and each of the multiple sensors being configured to: (i) reflect optical signals of different spectral widths based on received incident light; (ii) altering the characteristics of the reflected light signal to determine the physical state of the multi-core optical fiber.

21. The medical device system according to claim 20, characterized in that, The one or more signals are reflected light signals of different spectral widths of broadband incident light reflected from each of the plurality of reflection gratings. Determining whether the medical device has deviated from the target propulsion path and entered the patient's blood vessel based on one or more signals includes: determining whether the medical device has entered the patient's azygos vein based on the reflected light signal.

22. The medical device system according to claim 21, characterized in that, Determining whether the medical device has entered the blood vessel is based on the amount of fluctuation of the medical device indicated by the reflected light signal.

23. The medical device system according to claim 22, characterized in that, The fluctuation amount of the medical device is the amount at the distal tip of the medical device.

24. The medical device system according to claim 20, characterized in that, Determining whether the medical device has entered the blood vessel is based on the shape of the medical device indicated by the reflected light signal.

25. The medical device system according to claim 24, characterized in that, The shape of the medical device, indicated by the reflected light signal, is used as input to a machine learning machine configured to process the input and provide a result indicating a confidence level regarding whether the shape of the medical device indicates entry into the patient's blood vessels.

26. The medical device system according to claim 24, characterized in that, Determining whether the medical device has entered the blood vessel is based on the results of a trial-and-error method performed on the shape of the medical device indicated by the reflected light signal.

27. The medical device system according to claim 18, characterized in that, The one or more signals include electrocardiogram signals generated by electrocardiogram monitoring that propels the medical device through the patient's vascular system, and wherein determining whether the medical device has entered the vascular system is based at least in part on the electrocardiogram signals.

28. The medical device system according to claim 27, characterized in that, The one or more signals also include a reflected light signal reflected by a reflective grating included in a multi-core optical fiber, and wherein determining whether the medical device has entered the blood vessel is based at least in part on the electrocardiogram signal and the reflected light signal.

29. The medical device system according to claim 18, characterized in that, The one or more signals are voltage signals representing impedance measured near the distal tip of the medical device, and the determination of whether the medical device has entered the blood vessel is based at least in part on the voltage signals.

30. The medical device system according to claim 29, characterized in that, The one or more signals further include one or more of the following: (i) a reflected light signal reflected by a reflective grating included in a multi-core optical fiber; or (ii) an electrocardiogram signal generated by electrocardiogram monitoring that propels the medical device through the patient's vascular system, wherein determining whether the medical device has entered the vascular system is based at least in part on the voltage signal and one or more of the reflected light signal or the electrocardiogram signal.

31. The medical device system according to claim 18, characterized in that, The one or more signals represent the direction of blood flow near the distal tip of the medical device, and the determination of whether the medical device has entered the blood vessel is based at least in part on the direction of blood flow near the distal tip of the medical device.

32. The medical device system according to claim 31, characterized in that, One or more signals further include one or more of the following: (i) a reflected light signal reflected by a reflective grating included in a multi-core optical fiber; (ii) an electrocardiogram signal generated by electrocardiogram monitoring that propels the medical device through the patient's vascular system; or (iii) a voltage signal representing impedance measured near the distal tip of the medical device, wherein determining whether the medical device has entered the vascular system is based at least in part on the direction of blood flow, and one or more of the reflected light signal, the electrocardiogram signal, or the voltage signal.

33. The medical device system according to claim 18, characterized in that, The one or more signals represent pulse oximeter readings obtained near the distal tip of the medical device, and wherein determining whether the medical device has entered the blood vessel is based at least in part on the pulse oximeter readings.

34. The medical device system according to claim 33, characterized in that, One or more signals further include one or more of the following: (i) a reflected light signal reflected by a reflective grating included in a multi-core optical fiber; (ii) an electrocardiogram signal generated by electrocardiogram monitoring that propels the medical device through the patient's vascular system; (iii) a voltage signal representing impedance measured near the distal tip of the medical device; or (iv) the direction of blood flow near the distal tip of the medical device, and wherein determining whether the medical device has entered the vascular system is based at least in part on the pulse oximeter reading, and one or more of the reflected light signal, the electrocardiogram signal, the voltage signal, or the direction of blood flow.

35. The medical device system according to claim 18, characterized in that, The one or more signals represent optically based Doppler readings, and the determination of whether the medical device has entered the blood vessel is based at least in part on the optically based Doppler readings.

36. The medical device system according to claim 35, characterized in that, One or more signals further include one or more of the following: (i) a reflected light signal reflected by a reflective grating included in a multi-core optical fiber; (ii) an electrocardiogram signal generated by electrocardiogram monitoring that propels the medical device through the patient's vascular system; (iii) a voltage signal representing impedance measured near the distal tip of the medical device; (iv) the direction of blood flow near the distal tip of the medical device; or (v) a pulse oximeter reading obtained near the distal tip of the medical device, wherein determining whether the medical device has entered the vascular system is based at least in part on the pulse oximeter reading, and one or more of the reflected light signal, the electrocardiogram signal, the voltage signal, the direction of blood flow, or the pulse oximeter reading.

37. The medical device system according to claim 18, 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.

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