CN-122006069-A - Dislocation detection system

Abstract

Disclosed herein are systems, apparatus, and methods relating to detecting a misalignment of a medical device within a patient's vasculature (such as an odd vein). The medical device may include a multi-core fiber including a plurality of core fibers, wherein each of the plurality of core fibers includes a plurality of sensors configured to reflect an optical signal based on received incident light and to change a characteristic of the reflected optical signal for use in determining a physical state of the multi-core fiber. The system may include a console having a non-transitory computer readable medium storing logic that, when executed, causes operations of providing a broadband incident light signal to a multi-core fiber, receiving a reflected light signal, processing the reflected light signal, and determining whether a medical device has entered an odd vein of a patient based on the reflected light signal.

Inventors

• MISENER ANTHONY K.
• S. Saudes
• W. R. McLaughlin

Assignees

• 巴德阿克塞斯系统股份有限公司

Dates

Publication Date

20260512

Application Date

20210624

Priority Date

20200626

Claims (20)

1. 1. A non-transitory computer-readable medium having logic stored thereon, wherein when executed by one or more processors, the logic causes operations comprising: Providing a broadband incident light signal to a multi-core fiber included within a medical device, wherein the multi-core fiber includes a plurality of core fibers, each of the plurality of core fibers including a plurality of reflection grating fibers distributed along a longitudinal length of the respective core fiber, and each of the plurality of reflection gratings is configured to (i) reflect light signals of different spectral widths based on received incident light, and (ii) change a characteristic of the reflected light signals for use in determining a physical state of the multi-core fiber; receiving reflected light signals of different spectral widths of the broadband incident light reflected by each of the plurality of reflection gratings; processing 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 vessel of the patient.
2. 2. The non-transitory computer-readable medium of claim 1, wherein the vessel is an odd vein of the patient, and wherein determining whether the medical device has entered the odd vein is based on a shape of the medical device indicated by the reflected light signal.
3. 3. The non-transitory computer readable medium of claim 2, wherein the shape of the medical device indicated by the reflected light signal is used as an input to machine learning configured to process the input and provide a result indicating a confidence level as to whether the shape of the medical device indicates an odd vein into the patient.
4. 4. The non-transitory computer-readable medium of claim 2, wherein determining whether the medical device has entered the odd vein is based on a heuristic result performed on a shape of the medical device indicated by the reflected light signal.
5. 5. The non-transitory computer-readable medium of claim 1, wherein the vessel is an odd vein of the patient, and wherein determining whether the medical device has entered the odd vein is based on an amount of fluctuation of the medical device indicated by the reflected light signal.
6. 6. The non-transitory computer readable medium of claim 5, wherein the amount of fluctuation of the medical device is an amount of fluctuation at a distal tip of the medical device.
7. 7. The non-transitory computer readable medium of claim 1, wherein the vessel is an odd vein of the patient, and wherein determining whether the medical device has entered the odd vein is based on a shape of the medical device indicated by the reflected light signal and electrocardiogram monitoring of advancing the medical device through a vasculature of the patient.
8. 8. The non-transitory computer readable medium of claim 1, wherein the vessel is an odd vein of the patient, and wherein determining whether the medical device has entered the odd vein is based on a shape of the medical device indicated by the reflected light signal and impedance sensing of advancing the medical device through a vasculature of the patient.
9. 9. The non-transitory computer readable medium of claim 1, wherein the vessel is an odd vein of the patient, and wherein determining whether the medical device has entered the odd vein is based on (i) a shape of the medical device indicated by the reflected light signal, (ii) electrocardiographic monitoring of advancing the medical device through a vasculature of the patient, and (iii) impedance sensing of advancing the medical device through the vasculature of the patient.
10. 10. The non-transitory computer readable medium of claim 1, wherein the vessel is an odd vein of the patient, and wherein determining whether the medical device has entered the odd vein is based on a shape of the medical device indicated by the reflected light signal and a blood flow direction within a portion of a vasculature of the patient in which the medical device is currently disposed.
11. 11. The non-transitory computer-readable medium of claim 1, wherein the vessel is an odd vein of the patient, and wherein determining whether the medical device has entered the odd vein is based on one or more of a shape of the medical device indicated by the reflected light signal and (i) an electrocardiogram monitoring of the medical device through a vasculature of the patient, (ii) an impedance sensing of the medical device through the vasculature of the patient, or (iii) a detection of a direction of blood flow within a portion of the vasculature of the patient in which the medical device is currently disposed.
12. 12. The non-transitory computer-readable medium of claim 1, wherein the vessel is an odd vein of the patient, and wherein determining whether the medical device has entered the odd vein is based on (i) a shape of the medical device indicated by the reflected light signal, (ii) electrocardiographic monitoring of advancing the medical device through a vasculature of the patient, (iii) impedance sensing of advancing the medical device through the vasculature of the patient, and (iv) blood flow direction detection within a portion of the vasculature of the patient in which the medical device is currently disposed.
13. 13. The non-transitory computer readable medium of claim 1, wherein the different types of strain comprise compression and tension.
14. 14. The non-transitory computer readable medium of claim 1, wherein the vessel is an odd vein of the patient.
15. 15. The non-transitory computer readable medium of claim 1, wherein the medical device is a stylet removably inserted into a lumen of a catheter assembly for placement of a distal tip of the catheter assembly in an superior vena cava of the vasculature.
16. 16. The non-transitory computer-readable medium of claim 1, wherein at least two of the plurality of core fibers are subjected to different types of strain in response to a change in orientation of the multi-core optical fiber.
17. 17. The non-transitory computer-readable medium of claim 1, wherein each of the plurality of reflective gratings changes its reflected optical signal by applying a wavelength shift that depends on the strain experienced by the reflective grating.
18. 18. A medical device system for detecting misalignment of a medical device within a vessel of a patient, the medical device system comprising: the medical device configured for advancement through the vessel of the patient, and A console comprising 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 comprising: receiving one or more signals from the medical device representative of one or more parameters indicative of the position of a distal tip of the medical device within the vessel of the patient, Processing the one or more signals to determine a position of the distal tip, and Based on the one or more signals, it is determined whether the medical device has deviated from a target advancement path and has entered the vessel of the patient.
19. 19. The medical device system of claim 18, wherein the vessel is an odd vein.
20. 20. The medical device system of claim 18, wherein the medical device comprises a multi-core optical fiber having a plurality of core fibers, each of the plurality of core fibers including a plurality of sensors distributed along a longitudinal length of the respective core fiber, and each sensor of the plurality of sensors is configured to (i) reflect light signals of different spectral widths based on received incident light, and (ii) change a characteristic of the reflected light signals for use in determining a physical state of the multi-core optical fiber.

Description

Dislocation detection system Case division information The application is a divisional application of an application patent application with the application number 202110706498.3 and the application name of a dislocation detection system, which is filed 24 days of 6 months of 2021. Priority The present application claims priority from U.S. provisional application No. 63/044,911, filed on 6/26 of 2020, which is incorporated herein by reference in its entirety. Technical Field The present application relates to the field of medical devices, and more particularly to a misalignment detection system. Background In the past, certain intravascular guides of medical devices (such as guidewires and catheters), for example, have used fluoroscopic methods to track the tip of the medical device and determine if the distal tip is properly positioned in its target anatomy. However, such fluoroscopy procedures expose the patient and their attending physician to harmful X-ray radiation. Furthermore, in some cases, the patient is exposed to potentially harmful contrast agents required for the fluoroscopic procedure. Recently, electromagnetic tracking systems involving a stylet have been used. Generally, electromagnetic tracking systems are characterized by three components, a field generator, a sensor unit and a control unit. The field generator generates a position-changing magnetic field for establishing a coordinate space using a plurality of coils. For example, attached to the stylet (such as near the distal end (tip) of the stylet), the sensor unit comprises a small coil in which a current is induced via a magnetic field. Based on the electrical characteristics of each coil, the position and orientation of the medical device may be determined in a coordinate space. The control unit controls the field generator and captures data from the sensor unit. While electromagnetic tracking systems avoid line-of-sight dependence of tracking the tip of the stylet while avoiding radiation exposure and potentially harmful contrast agents associated with fluoroscopic methods, electromagnetic tracking systems are prone to interference. More specifically, since electromagnetic tracking systems rely on the measurement of the magnetic field generated by the field generator, these systems experience electromagnetic field interference, which may be caused by the presence of many different types of consumer electronic devices such as cellular telephones. In addition, electromagnetic tracking systems experience signal loss, rely on external sensors, and are limited in depth range. Disclosed herein is a system and method for determining, based on one or more signals from a medical device, whether the medical device inserted into a patient has deviated from a target advancement path and has entered a vessel of the patient. Disclosure of Invention In brief, 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 stylet) during advancement through the vasculature of a patient and determining misalignment of the medical device within a vessel (such as an odd vein (Azygos vein). In some embodiments, the systems are fiber optic shape sensing systems and methods thereof configured to provide confirmation or transfer/interpretation of tip position as information of an electrical signal. More specifically, in some embodiments, the medical device includes a multi-core optical fiber, each core fiber of the multi-core optical fiber being configured with a sensor array (reflection grating) spatially distributed over a prescribed length of the core fiber to generally sense external strain on those areas of the core fiber occupied by the sensors. The multi-core optical fiber is configured to receive broadband light from the console during advancement through the vasculature of the patient, wherein the broadband light propagates distally along at least a portion of the distance of the multi-core optical fiber. Where each sensor positioned along the same core fiber is configured to reflect a different specific spectral width of light, the sensor array enables distributed measurements over a prescribed length of multi-core fiber. These distributed measurements may include wavelength shifts that are correlated to the strain experienced by the sensor. Reflected light from the sensors (reflection gratings) within each core fiber of the multi-core fiber is returned from the medical instrument for processing by the console. The physical state of the medical device may be determined based on an analysis of the wavelength shift of the reflected light. For example, the strain induced by bending of the medical device and thus the angular variation of each core fiber causes a varying degree of deformation. The varying degrees of deformation change the shape of the sensors (reflective gr