OSS-based automatic feature detection and equipment characterization

Abstract

Various embodiments of the present disclosure include an optical shape sensing alignment system that uses an optical shape sensing guidewire 30 movable within an over-the-wire device 40 and further uses an optical shape sensing alignment controller 20 to control autonomous device alignment of the over-the-wire device 40. In operation, the optical shape sensing alignment controller 20 automatically detects one or more sensed characteristics of the optical shape sensing guidewire 30 (e.g., shape, curvature, temperature, vibration, strain, etc.) from optical shape sensing of movement of the optical shape sensing guidewire 30 within the over-the-wire device 40, and then automatically determines one or more alignment characteristics of the over-the-wire device 40 (e.g., device type, length, diameter, color, hub type, treatment device, anatomical image, anatomical model, anatomical site, procedure type, etc.) from the automated detection of the sensed characteristics of the optical shape sensing guidewire 30.

Description

[Technical Field]

[0001] The present disclosure relates generally to optical shape sensing, and more particularly to optical shape sensing as a basis for automatically detecting features of an optical shape sensing guidewire and automatically determining characteristics of an over-the-wire device within which the optical shape sensing guidewire travels. [Background technology]

[0002] Optical Shape Sensing (OSS) uses light along a multicore optical fiber for instrument localization and navigation during surgical intervention. The principle involved utilizes distributed strain measurements within the optical fiber defined by a characteristic Rayleigh backscatter or controlled grating pattern (e.g., fiber Bragg grating). The shape along the optical fiber starts from a specific point along the sensor (known as the launch or z=0), and the subsequent position and orientation of the shape are referenced to that point.

[0003] Integrating optical shape-sensing fibers into medical devices can provide live guidance of the device during minimally invasive procedures. The integrated fiber provides the position and orientation of the entire device, e.g., a catheter loaded onto a shape-sensing guidewire, for navigation to the anatomical target. The shape-sensing guidewire thereby facilitates overlay of the catheter on preoperative computed tomography images of the anatomical target. Summary of the Invention [Problem to be solved by the invention]

[0004] To support spatial tracking of medical devices during minimally invasive procedures, the alignment characteristics of the medical device must be known, and these alignment characteristics must be determined with minimal disruption to the workflow of the minimally invasive procedure. [Means for solving the problem]

[0005] With respect to the numerous and varied applications involving spatial tracking of over-the-wire (OTW) devices, this disclosure describes controllers, systems, and methods for automatically determining the required device characterization necessary for accurate and robust spatial tracking of OTW devices via optical shape sensing (OSS) guidewires in a manner that minimizes interruption to the application's workflow, or for annotation, reporting, documentation, etc. Examples of such applications include, but are not limited to, vascular applications (e.g., via catheters, sheaths, deployment systems), intraluminal applications (e.g., via endoscopes), and orthopedic applications (e.g., via k-wires and screwdrivers).

[0006] The present disclosure provides: (1) the OSS alignment controller of the present disclosure; (2) an OSS alignment system incorporating the OSS alignment controller of the present disclosure; and (3) This can be embodied as an OSS alignment method using the OSS alignment controller of the present disclosure.

[0007] In various embodiments, the OSS alignment system of the present disclosure includes a movable OSS guidewire within the OTW device and further includes an OSS alignment controller for controlling autonomous device alignment of the OTW device.

[0008] In operation, the OSS alignment controller (1) automatically detects one or more sensed characteristics of the OSS guidewire (e.g., shape, curvature, temperature, vibration, strain, torsion, alpha, etc.) from optical shape sensing of the movement of the OSS guidewire within the over-the-wire device, and (2) automatically determines one or more alignment characteristics of the OTW device (e.g., type, length, diameter, color, hub, treatment device, anatomical image, anatomical model, anatomical site, etc.) from the automated detection of the sensed characteristics of the OSS guidewire.

[0009] Various embodiments of the OSS alignment controller of the present disclosure include a non-transitory machine-readable storage medium encoded with instructions for execution by one or more processors to control autonomous device alignment of an OTW device movable within an OSS guidewire.

[0010] The non-transitory machine-readable storage medium includes instructions for (1) automatically detecting one or more sensed characteristics of the OSS guidewire (e.g., shape, curvature, temperature, vibration, strain, etc.) from optical shape sensing of movement of the OSS guidewire within the OTW device, and (2) automatically determining one or more alignment characteristics of the OTW device (e.g., type, length, diameter, color, hub, treatment device, anatomical image, anatomical model, anatomical site, etc.) from the automated detection of the sensed characteristics of the OSS guidewire.

[0011] Various embodiments of the OSS alignment method of the present disclosure utilize an OSS alignment controller to control autonomous device alignment of an OTW device movable within an OSS guidewire.

[0012] The OSS registration method involves an optical shape sensing registration identification controller that (1) automatically detects one or more sensed characteristics of the OSS guidewire (e.g., shape, curvature, temperature, vibration, strain, torsion, alpha, etc.) from optical shape sensing of the movement of the OSS guidewire within the OTW device, and (2) automatically determines one or more registration characteristics of the OTW device (e.g., device type, length, diameter, color, hub type, treatment device, anatomical image, anatomical model, anatomical site, etc.) from the automated detection of the sensed characteristics of the OSS guidewire.

[0013] The above and other embodiments of the present disclosure, as well as various features and advantages of the present disclosure, will become more apparent from the following detailed description of various embodiments of the present disclosure, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the present disclosure, rather than limiting, the scope of which is defined by the appended claims and their equivalents. [Brief explanation of the drawings]

[0014] The present disclosure will now be described in detail with reference to the following figures, which illustrate exemplary embodiments.

[0015] [Figure 1] FIG. 1 illustrates an exemplary embodiment of an OSS registration system according to the present disclosure. [Figure 2] FIG. 2 illustrates an exemplary embodiment of an OSS registration method according to the present disclosure. [Figure 3] FIG. 3 shows a flowchart illustrating a first exemplary embodiment of the OSS registration method of FIG. 2 according to the present disclosure. [Figure 4] FIG. 4 shows a flowchart illustrating an exemplary embodiment of an automatic hub detection method according to the present disclosure. [Figure 5A] FIG. 5A illustrates an exemplary graphical automatic hub detection according to the present disclosure. [Figure 5B] FIG. 5B illustrates an exemplary graphical automatic hub detection according to the present disclosure. [Figure 6]FIG. 6 shows a flowchart illustrating an exemplary embodiment of an automated OTW device measurement method according to the present disclosure. [Figure 7] FIG. 7 shows a flowchart illustrating an exemplary embodiment of an OSS peak measurement method according to the present disclosure. [Figure 8] FIG. 8 illustrates an exemplary OSS peak measurement according to the present disclosure. [Figure 9] FIG. 9 shows a flowchart depicting an exemplary embodiment of an OSS distal curvature measurement method according to the present disclosure. [Figure 10] FIG. 10 illustrates an exemplary OSS distal curvature measurement according to the present disclosure. [Figure 11] FIG. 11 shows a flowchart illustrating an exemplary embodiment of an OSS shape matching measurement method according to the present disclosure. [Figure 12] FIG. 12 illustrates an exemplary OSS shape matching measurement according to the present disclosure. [Figure 13] FIG. 13 shows a flowchart illustrating a second exemplary embodiment of the OSS registration method of FIG. 2 according to the present disclosure. [Figure 14] FIG. 14 illustrates an exemplary embodiment of an OSS alignment controller according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] The present disclosure improves device alignment during applications involving spatial tracking of over-the-wire (OTW) devices by (1) automatically detecting one or more sensed characteristics (e.g., shape, curvature, temperature, vibration, strain, torsion, alpha, etc.) of an optical shape sensing (OSS) guidewire from optical shape sensing of the movement of the OSS guidewire within the OTW device, and (2) automatically determining one or more alignment characteristics (e.g., type, length, diameter, color, hub, treatment device, anatomical image, anatomical model, anatomical site, etc.) of the OTW device from the automated detection of the sensed characteristics of the OSS guidewire.

[0017] For purposes of describing and claiming this disclosure, the following definitions are provided: (1) Terms of the art, including but not limited to “optical shape sensing (OSS),” “OSS guidewire,” “over-the-wire (OTW) device,” “hub,” “hub template,” “autonomous (and its tense),” and “automatic (and its tense),” shall be interpreted as known in the art of this disclosure and as illustratively described herein. (2) More specifically, the term "OSS guidewire" broadly encompasses wires, springs, and the like, as known in the art of this disclosure and as contemplated below, that incorporate optical shape sensing to guide the spatial positioning of an OTW device. (3) Examples of OTW devices include, but are not limited to, catheters, deployment systems, and sheaths. (4) More specifically, the term "hub" broadly encompasses any object known in the art of this disclosure and as contemplated below to refer to optical shape sensing of an OTW device over an OSS guidewire. Examples of hubs include, but are not limited to, a unicath hub, a luer lock hub, an over-catheter hub, a hemostatic valve hub, a guidewire torque hub, and an introducer hub. (5) More specifically, the term "hub template" broadly encompasses the shape profile, curvature profile, or strain profile of an OSS guidewire formed within a hub. (6) The term “autonomous device alignment” broadly encompasses one or more autonomous operations performed by a controller for the purpose of determining alignment characteristics of an OTW device related to spatial tracking of the OTW device, as illustratively described in this disclosure. (7) The term “automatic” broadly encompasses one or more autonomous operations performed by a controller that rely on optical shape sensing of the movement of an OSS guidewire within an OTW device, as illustratively described in this disclosure. (8) The term "sensing characteristic" broadly encompasses a characteristic of an OSS guidewire obtained from interrogation of the OSS guidewire, as known in the art of the present disclosure. The sensing characteristic may be obtained from the OSS guidewire itself, a hub that introduces a characteristic into the OSS guidewire, or an OTW device that introduces a characteristic into the OSS guidewire. Examples of sensing characteristics of an OSS guidewire include, but are not limited to, the shape, curvature, temperature, vibration, and strain of a segment or the entire OSS guidewire. (9) The term "alignment characteristic," as known in the art of this disclosure, broadly encompasses characteristics of an OTW device that serve as variables or alignment characteristics of the spatial alignment of the OTW device with an OSS device for tracking purposes. Examples of alignment characteristics of an OTW device include, but are not limited to, the device type, length, diameter, and color of the OTW device, and the hub type, treatment device, anatomical image, anatomical model, anatomical site, and procedure type associated with the OTW device. (10) The term "lookup table" or "LUT" encompasses databases of templates and device characteristics defined pre- or during a procedure. Examples of such databases include, but are not limited to, lookup tables as known in the art and databases generated by artificial intelligence. (11) The term “controller,” as understood in the art and as illustratively described herein, broadly encompasses any structural arrangement having a main circuit board and / or integrated circuits for controlling the application of the various principles of the present disclosure as illustratively described herein. (12) The term “application module” broadly encompasses an application embedded in or accessible from a controller that is comprised of electronic circuitry (e.g., electronic components and / or hardware) and / or executable programs (e.g., executable software stored on a non-transitory computer-readable medium and / or firmware) for executing a particular application of the present disclosure as illustratively described herein. (13) The terms "signal" and "data," as understood in the art of this disclosure and as illustratively described herein, broadly encompass any form of detectable physical quantity or impulse (e.g., voltage, current, or magnetic field strength) for transmitting information and / or instructions in support of applying the various inventive principles of this disclosure as described below in this disclosure. Signal / data communication by the various components of this disclosure may involve any communication method as known in the art of this disclosure, including, but not limited to, sending and receiving signals / data over any type of wired or wired data link, and reading signals / data uploaded to a computer-usable / computer-readable storage medium.

[0018] To facilitate understanding of the present disclosure, the following description of Figures 1 and 2 teaches exemplary embodiments of an OSS registration system and an OSS registration method, respectively, according to the present disclosure. Those skilled in the art of the present disclosure will understand from the description of Figures 1 and 2 how to apply the present disclosure to make and use additional embodiments of the OSS registration system and OSS registration method of the present disclosure for any type of OTW device.

[0019] Referring to FIG. 1, the OSS alignment system of the present disclosure employs an OSS alignment controller 20 and an OSS guidewire 30.

[0020] In effect, OSS guidewire 30 is a guidewire with an optical shape sensor embedded with optical fibers, as known in the art of this disclosure.

[0021] In one exemplary embodiment, the optical shape sensor is based on a fiber optic Bragg grating sensor. A fiber optic Bragg grating (FBG) is a short segment of optical fiber that reflects specific wavelengths of light and transmits all other wavelengths. This is achieved by adding periodic variations in refractive index to the fiber core, which create wavelength-specific dielectric minors. Fiber Bragg gratings can therefore be used as in-line optical filters that block specific wavelengths or as wavelength-specific reflectors.

[0022] In particular, FBG sensors use Fresnel reflection at each interface where the refractive index changes. At some wavelengths, the reflected light of different periods is in phase, so there is constructive interference in reflection and, as a result, destructive interference in transmission. The Bragg wavelength is sensitive not only to temperature but also to strain. This means that Bragg gratings can be used as the sensing element in fiber optic sensors. In FBG sensors, the measured value (e.g., strain) causes a shift in the Bragg wavelength.

[0023] In a second exemplary embodiment, the optical shape sensor is based on intrinsic backscattering. One such approach uses Rayleigh scattering (or other scattering) in standard single-mode telecommunications fiber. Rayleigh scattering occurs as a result of random variations in the refractive index of the fiber core. These random variations can be modeled as a Bragg grating with random variations in amplitude and phase along the grating length. This effect can be used with three or more cores extending within a single length of multicore fiber to track the 3D shape and dynamics of a surface of interest.

[0024] One advantage of the OSS guidewire 30 is that various sensor elements can be distributed along the length of the fiber. By incorporating three or more cores with various sensors (gauges) along the length of the fiber embedded within a structure, the three-dimensional contours of such structures can be accurately determined, typically with an accuracy better than 1 mm. Many FBG sensors can be placed at various locations along the length of the fiber. From the strain measurements of each FBG, the curvature of the structure can be inferred at that location. From the many measured locations, the overall three-dimensional contour can be determined.

[0025] 1 , in practice, the OSS alignment controller 20 or another controller interfaces with an optical interrogator, including or associated with a light source, as known in the art of the present disclosure, whereby the controller 20 (or another controller) controls the operation of the optical interrogator to transmit and receive optical signals from the OSS guidewire 30, as known in the art of the present disclosure, that represent sensed characteristics of the OSS guidewire 30 (e.g., the shape, curvature, temperature, vibration, and strain of a segment or the entire OSS guidewire 30). The controller 20 (or another controller) further controls the reconfiguration of the shape of the OSS guidewire 30 based on the received optical signals (i.e., shape-sensed data), as known in the art of the present disclosure.

[0026] 1 , the OSS registration system of the present disclosure further employs OTW devices in the form of catheter 40a having hub 50 attached to its proximal end (e.g., via a luer lock), and catheter 40b having hub 50 (not shown) attachable to its proximal end. Hub 50 includes a unique template formed in the hub body to distinguish portions of OSS guidewire 30 within the hub body via shape sensing data, as is known in the art of the present disclosure.

[0027] Indeed, the OTW device may take alternative forms, including but not limited to, deployment systems and sheaths, as are known in the art of this disclosure.

[0028] Additionally, in practice, the catheter 40 may be manually or robotically front-loaded or back-loaded onto the OSS guidewire 30. This allows the OSS alignment controller 20 to control the determination of the device alignment of the catheter 40, which involves one or more autonomous operations performed by the OSS alignment controller 20 to determine alignment characteristics of the catheter 40 related to spatial tracking of the catheter 40.

[0029] Examples of alignment characteristics of catheter 40 include the catheter type, length, diameter, and color of catheter 40, as well as the hub type, treatment device, anatomical image, anatomical model, anatomical site, and procedure type associated with catheter 40.

[0030] In one exemplary embodiment, the alignment characteristic of the catheter 40 is the type of hub 50 attached or attachable to the catheter. To determine this alignment characteristic, the OSS alignment controller 20 employs a hub detection module for automatically detecting the hub template of the hub 50 relative to the OSS guidewire 30 from optical shape sensing of the movement of the OSS guidewire 30 through the hub template, as described further in this disclosure, or by automatically detecting the device type of the catheter 40b from optical shape sensing of the movement of the OSS guidewire 30 within the catheter 40b, as described further in this disclosure.

[0031] In a second exemplary embodiment, the alignment characteristic of the catheter 40 is the length of the catheter 40. To determine this alignment characteristic, the OSS alignment controller 20 employs an OTW instrument measurement to automatically obtain a measurement of the length of the catheter 40 from optical shape sensing of the movement of the OSS guidewire 30 within the catheter 40, as described further in this disclosure.

[0032] Referring to FIG. 2, a state machine 60 is shown representing the OSS positioning method 60 of the present disclosure implemented as an OSS guidewire (e.g., OSS guidewire 30 of FIG. 1) moves through an OTW device (e.g., catheter 40 of FIG. 1).

[0033] In state ST61 of state machine 60, an OSS positioning controller of the present disclosure (eg, controller 20 of FIG. 1) controls the interrogation of an OSS guidewire moving within the OTW device via command signal 70a.

[0034] In state ST62 of state machine 60, the OSS alignment controller processes OSS data 71 generated through interrogation of the OSS guidewire to detect one or more sensed characteristics of the OSS guidewire (e.g., segment or overall shape, curvature, temperature, vibration, and strain of the OSS guidewire) as known in the art of the present disclosure.

[0035] In state ST63 of state machine 60, the OSS alignment controller processes detected feature data 72 indicative of detected features of the OSS guidewire to evaluate whether one or more alignment characteristics of the OTW device are derived from the detected features of the OSS guidewire.

[0036] If one or more alignment characteristics of the OTW device are obtained from the detected features of the OSS guidewire, the OSS alignment controller outputs device alignment characteristic data 73 of the OTW device (e.g., the device type, length, diameter, and color of the OTW device, and the hub type, treatment device, anatomical image, anatomical model, anatomical site, and procedure type associated with the OTW device) to facilitate spatial tracking of the OTW device.

[0037] More specifically, detected features of the OSS guidewire can be used to delineate the contours of the anatomical site. For example, the detected shape of the OSS guidewire may correspond to a particular shape of the anatomical site, such that detecting the shape of the OSS guidewire as it is navigated within the anatomical region identifies the positioning and / or orientation of the OSS guidewire (and OTW device) within the anatomical site.

[0038] If one or more alignment characteristics of the OTW device cannot be obtained from the detected features of the OSS guidewire, the OSS alignment controller controls, via command signal 70b, the interrogation of the OSS guidewire further within the OTW device, thereby repeating states ST61-ST63 until alignment characteristics of the OTW device can be obtained from the detected features of the OSS guidewire. To facilitate a better understanding of the present disclosure, the following descriptions of FIGS. 3-13 teach exemplary implementations of the OSS alignment system of FIG. 1 and the OSS alignment method of FIG. 2, respectively, according to the present disclosure, for detecting OSS guidewire features as a basis for obtaining alignment characteristics of the OTW device, as illustrated by FIG. 2. Those skilled in the art of the present disclosure will understand from the descriptions of FIGS. 3-13 how to apply the present disclosure to make and use additional embodiments of the OSS alignment system of FIG. 1 and the OSS alignment method of FIG. 2 for any type of OTW device.

[0039] FIG. 3 shows flowcharts 100 and 200 illustrating the OSS alignment method of the present disclosure, which is particularly applicable to an OTW device in an attached hub, such as, for example, catheter 40 of FIG.

[0040] Referring to FIG. 3, flowcharts 100 and 200 cover a user-operated and controller-executed workflow for determining alignment characteristics that define the spatial tracking of a catheter 40 relative to an attached hub 50, or another OTW device relative to an attached hub.

[0041] Broadly speaking, the implementation of the first phase of user interaction / controller execution consists of steps S102 and S104 of flowchart 100 and steps S202 and S204 of flowchart 200 for detecting the hub template as the OSS guidewire 30 moves through the hub 50 and determining the type of hub 50.

[0042] The implementation of the second phase of user operation / controller execution consists of steps S106 and S108 of flowchart 100 and steps S206 and S208 of flowchart 200 for measuring the catheter 40 as the OSS guidewire 30 moves through the catheter 40.

[0043] Before beginning flowcharts 100 and 200, a look-up table (LUT) 203 is defined that consists of a number of predefined hub types and associated unique templates. This allows a detected hub template to be looked up for its corresponding hub type, as described further in this disclosure. In practice, the various hub templates contain uni-cus hubs with varying degrees of curvature or different shapes.

[0044] Additionally, a LUT 207 is defined, which consists of many predefined catheters and associated shape or curvature profiles. This allows a specific type of catheter to be identified based on the detected catheter shape or curvature. For example, the LUT 207 includes shape or curvature profiles for several known devices (e.g., Cobra catheters, SOS catheters, VS1 catheters, etc.).

[0045] 3, step S102 of flowchart 100 includes a first user action involving attaching the hub 50 to the catheter 40, and step S104 of flowchart 100 includes a second user action involving manually or robotically moving the OSS guidewire 30 through the hub 50. Steps S102 and S104 of flowchart 100 initiate steps S202 and S204 of flowchart 200 for automatically detecting the type of hub 50 attached to the catheter 40. Steps S202 and S204 of flowchart 200 are initiated by one or more of the following inputs:

[0046] In one exemplary embodiment, user input 301 indicates to controller 20 that hub 50 is attached to catheter 40 and that OSS guidewire 30 is about to be inserted into hub 50. User input 301 may be in the form of a visual, verbal, and / or manual cue.

[0047] In a second exemplary embodiment, a sensor is incorporated into the hub 50. The sensor sends a sensor input signal 302 to the controller 20 when it senses attachment of the hub 50 to the catheter 40 or when it senses contact of the OSS guidewire 30 with the hub 50. Additionally, additional sensors may be incorporated into other equipment, such as on the table or in the room, to sense when steps S102 and / or S104 have occurred.

[0048] In a third exemplary embodiment, the controller 20 (or another controller) executes an algorithm that continuously examines the shape data from the OSS guidewire 30 to detect the formation of a minimum curvature at the distal end of the OSS guidewire 30. When the algorithm identifies a minimum curvature in the shape data, an algorithm signal 303 triggers step S202.

[0049] In a fourth exemplary embodiment, imaging information 304 extracted from imaging such as x-ray, ultrasound, optical / camera, etc. may also be used to identify when a catheter 40 is present and when a hub 30 is in use. This identification is used as a trigger to initiate step S202.

[0050] The first phase, implemented by steps S202 and S204, involves continuous processing of shape-sensing data of the OSS guidewire 30 in step S202 as the OSS guidewire moves through the hub template in step S104. Thus, in step S204, the controller 20 attempts to match the current shape data of the OSS guidewire 30 to a predefined hub template in the LUT 203. The predefined hub template with the least error is defined as the best-matching hub, and its hub type (or classification) is saved.

[0051] FIG. 4 illustrates an exemplary embodiment of the first phase.

[0052] 4, in step S402 of flowchart 400, the hub 50 is attached to the catheter 40, and the hub 50 is front-loaded or back-loaded onto the OSS guidewire 30, as shown, followed by optical shape sensing of the movement of the OSS guidewire 30 through the hub template. In step S402, the user can click a button to initialize the controller 20, or the controller 20 can be constantly running and detect when the hub 50 is connected to the catheter 40 based on signal processing and signal optimization techniques known in the art.

[0053] In step S404 of the flowchart 400, the controller 20 compares the current shape data of the OSS guidewire 30 with the predefined hub templates in the LUT 203. The predefined hub template with the smallest error is selected as the detected hub template. The error function follows the following equation [1]:

number

[0054] In practice, the area under the hub template is normalized, which would otherwise favor smaller templates over larger ones.

[0055] The template location is indicated to the user. If an incorrect template location or template is selected, the user can "window" the search area. The search area can also be windowed without user input to exclude portions of the OSS guidewire 30 that are inside or outside the body (by checking the gradient in axial strain), or the most distal portion of the sensor (e.g., the last 10 cm).

[0056] Once the template location is selected in step S406 of flowchart 400, in step S408 of flowchart 400, controller 20 obtains (extracts) the actual hub template curvature from the shape of the region that matches the stored hub template.

[0057] FIG. 5A shows a predefined hub template matched to the optically shape-sensed curvature of an OSS guidewire 30 moving through the hub template, and FIG. 5B shows a close-up of the correct match.

[0058] 3 , step S106 of flowchart 100 includes a third user action of manually or robotically moving OSS guidewire 30 through catheter 40, and step S108 of flowchart 100 includes a fourth user action of manually or robotically extending the distal end of OSS guidewire 30 from hub 50. Steps S106 and S108 of flowchart 100 initiate steps S206 and S208 of flowchart 200 for automatically measuring the length of catheter 40.

[0059] FIG. 6 illustrates an exemplary embodiment of the second phase.

[0060] Referring to FIG. 6, in step S502 of flowchart 500, after optically sensing the shape of the OSS guidewire 30 manually or robotically moving through the hub template as shown in FIG. 4, optically sensing the shape of the OSS guidewire 30 manually or robotically moving through the catheter 40 as shown in the figure.

[0061] In step S504 of flowchart 500, detector 21 of controller 20 automatically obtains a length measurement of catheter 40 relative to hub 50 from step S502 of optically shape-sensing the movement of OSS guidewire 30 through catheter 40. The optical shape sensing involves alignment or extension of distal tip 31 of OSS guidewire 30 with distal tip 41 of catheter 40. To this end, detector 21 of controller 20 includes a database 209 of catheter shapes 51 a, including, but not limited to, Tiger catheters, Jackie catheters, amplatz left catheters, LCB catheters, RCB catheters, Judkins left catheters, Judkins right catheters, multipurpose A2 catheters, IM catheters, 3D lima catheters, and IM VB-1 catheters.

[0062] In step S506 of the flowchart, the controller 20 obtains the measured catheter length for optical shape sensing reconstruction of the shape of the catheter 40, as known in the art of this disclosure or as contemplated below.

[0063] An exemplary embodiment of step S504 will now be described.

[0064] FIG. 7 shows a flowchart 510 illustrating the OSS peak measurement method of the present disclosure. Referring to FIG. 7 , in step S512 of flowchart 510, the controller 20 stores the average curvature of the tip 31 of the OSS guidewire 30 at each point in time from when the OSS guidewire 30 starts at the proximal end of the catheter 40 until it is pushed up to and beyond the distal tip 41 of the catheter 40, and plots the average tip curvature against the position of the hub 50. In step S512, when the tip 31 of the OSS guidewire 30 reaches the distal tip 41 of the catheter 40, there is a large, sudden increase in the average curvature, followed by a sudden decrease in the average curvature of the tip 31 of the OSS guidewire 30. The spike in curvature defines the point where the tips 31, 41 of the two devices 30, 40 are aligned.

[0065] For example, Figure 8 shows a graph 151 plotting a large, sudden increase in the mean curvature of the tip 31 of the OSS guidewire 30 as it reaches the distal tip 41 of the catheter 40, followed by a sudden decrease in the mean curvature of the tip 31 of the OSS guidewire 30. The spike in curvature defines the point where the tips 31, 41 of the two devices 30, 40 are aligned.

[0066] 7, in step S514 of flowchart 510, controller 20 continuously monitors the plot for a decrease in mean tip curvature. If controller 20 identifies a decrease in mean tip curvature, in step S516 of flowchart 510, controller 20 uses this spike in mean tip curvature to extract the unicus hub index position at the peak so that the length of catheter 40 can be defined. From here, additional device characteristics can be obtained by matching the current OTW device or hub to a lookup table of predefined device characteristics.

[0067] FIG. 9 shows a flowchart 520 illustrating the OSS distal curvature method of the present disclosure. Referring to FIG. 9 , in step S522 of flowchart 500, the controller 20 stores the curvature of the distal tip of the OSS guidewire 30 at each point in time between when the OSS guidewire 30 starts at the proximal end of the catheter 40 and when it is pushed up to and beyond the distal tip 41 of the catheter 40, and plots the tip curvature against the position of the hub 50. For each frame, peaks in the curvature signal are found. Each peak is labeled A, B, C, or 1, 2, 3, etc. Labels are initialized in the first data frame. For each new frame, the label is applied to the peak closest to the last peak. In this way, a particular curve on the catheter 40 is labeled, and its position relative to the OSS guidewire 30 can be consistently identified.

[0068] 10 shows an exemplary graph 153 of a curvature plot of the distal tip of the OSS guidewire 30. The color-coded lines are from three different time points when the distal tip of the OSS guidewire 30 is at different positions 80, 81, and 82 within the catheter 40. The numbered circles indicate the labels for each peak in the curvature profile.

[0069] More specifically, FIG. 10 shows a first time point (blue) when the guidewire 30 is still within the catheter 40. At this point, a curve is identified on the guidewire 30 and labeled (1). At a second time point (purple) when the guidewire 30 is still within the catheter 40 but slightly further away, curve (1) shifts more proximally on the guidewire 30. This continues, so that curve (1) eventually becomes more proximal on the guidewire 30. At the next time point (pink), the tip of the guidewire 30 passes the over-the-wire tip, and a new curve (2) appears. In this way, a curve can be calculated and a threshold defined for when the guidewire 30 exits the catheter 40.

[0070] 9, in step S524 of flowchart 520, an exit point of the OSS guidewire 30 from the catheter 40 is identified. The exit point defines the length of the catheter 40 in step S526 of flowchart 520.

[0071] FIG. 11 shows a flowchart 530 illustrating the OSS distal curvature method of the present disclosure. Referring to FIG. 11, in step S532 of flowchart 530, the controller 20 receives the current reconstructed shape of the OSS guidewire 30. Also in step S534 of flowchart 530, the measuring device 22 attempts to match the reconstruction of the OSS guidewire 30 to a predefined catheter curve stored in a lookup table of many predefined curves and associated lengths. Steps S532 and S534 are executed in a loop until the controller 20 identifies a match with the smallest error. This match indicates that the shape of the OSS guidewire 30 that most closely resembles the tip of the OSS guidewire 30 and the catheter 40 has been aligned. In step S536 of flowchart 530, the controller 20 obtains the length of the matched predefined catheter as the length of the catheter 40.

[0072] FIG. 12 shows that the currently reconstructed shape 140 of the OSS guidewire 30 is matched to the multipurpose A2 catheter 141h from a lookup table consisting of a Tiger catheter 141a, a Jackie catheter 141b, an Amplatz Left catheter 141c, an LCB catheter 141d, an RCB catheter 141e, a Judkins Left catheter 141f, a Judkins Right catheter 141g, a multipurpose A2 catheter 141h, an IM catheter 141i, a 3D Lima catheter 141j, and an IM VB-1 catheter 141k.

[0073] FIG. 13 shows flowcharts 110 and 210 illustrating the OSS alignment method of the present disclosure, which is particularly applicable to OTW devices that do not have a hub attached, such as catheter 40 of FIG.

[0074] Referring to FIG. 13, flowcharts 110 and 210 cover a user-operated and controller-implemented workflow for determining alignment characteristics that define spatial tracking of catheter 40 or another OTW device that does not have a hub attached.

[0075] Step S112 of flowchart 110 includes a first user action of manually or robotically moving the OSS guidewire 30 through the catheter 40, and step S114 of flowchart 110 includes a second user action of manually or robotically extending the tip of the OSS guidewire 30 from the distal tip of the catheter 40. Steps S112 and S114 of flowchart 110 initiate steps S212 and S214 of flowchart 210 for automatically measuring the length of the catheter 40.

[0076] Steps S212 and S214 of flowchart 210 are initiated by one or more of the following inputs:

[0077] In one exemplary embodiment, user input 301 indicates to controller 20 that OSS guidewire 30 is about to be inserted into catheter 40. User input 301 may be in the form of a visual, verbal, and / or manual cue.

[0078] In a second exemplary embodiment, a sensor is incorporated into the catheter 40. When the sensor senses that the OSS guidewire 30 is in contact with the catheter 40, it sends a sensor input signal 302 to the controller 20. Furthermore, additional sensors may be incorporated into other equipment, such as on the table or in the room, to sense when steps S112 and / or S114 have occurred.

[0079] In a third exemplary embodiment, the controller 20 (or another controller) executes an algorithm that continuously examines the shape data from the OSS guidewire 30 to detect the formation of a minimum curvature at the distal end of the OSS guidewire 30. When the algorithm identifies a minimum curvature in the shape data, an algorithm signal 303 triggers step S212.

[0080] In a fourth exemplary embodiment, imaging information 304 extracted from imaging such as x-ray, ultrasound, optical / camera, etc. may also be used to identify that the OSS guidewire 30 is in proximity to or in contact with the catheter 40. This identification is used as a trigger to initiate step S212.

[0081] Steps S212 and S214 involve continuous processing of shape-sensing data of the OSS guidewire 30 in step S212 as the OSS guidewire is moved through the catheter 40 in step S102. Thus, in step S214, the controller 20 attempts to match the current shape data of the OSS guidewire 30 to predefined catheter shapes in the look-up table (LUT) 213. The predefined catheter shape with the least error is defined as the best-matching catheter type, and that catheter type (or classification) is saved, from which alignment characteristics can be derived.

[0082] In one embodiment of step S214, the controller 20 receives the current reconstructed shape of the OSS guidewire 30 and attempts to match the reconstruction of the OSS guidewire 30 with a predefined curve of the catheter stored in a lookup table of many predefined curves and associated characteristics (including hub type). The controller 20 identifies the match with the smallest error. This match indicates that the shape of the OSS guidewire 30 that most closely resembles the tip of the OSS guidewire 30 and the catheter 40 is aligned. The controller 20 also captures the alignment characteristics of the matched predefined catheter shape as the alignment characteristics of the catheter 40.

[0083] 12 shows that the currently reconstructed shape 140 of the OSS guidewire 30 has been matched to the multipurpose A2 catheter 141h from a lookup table consisting of a Tiger catheter 141a, a Jackie catheter 141b, an AmplatzLeft catheter 141c, an LCB catheter 141d, an RCB catheter 141e, a JudkinsLeft catheter 141f, a JudkinsRight catheter 141g, a multipurpose A2 catheter 141h, an IM catheter 141i, a 3D Lima catheter 141j, and an IM VB-1 catheter 141k. Thus, the alignment characteristics of the multipurpose A2 catheter 141h determine the alignment characteristics of the catheter 40, particularly the type of hub attached to the catheter 40.

[0084] To facilitate a further understanding of the present disclosure, the following description of Figure 14 teaches an exemplary embodiment of an OSS alignment controller according to the present disclosure. Those skilled in the art of the present disclosure will understand from the description of Figure 14 how to apply the present disclosure to make and use additional embodiments of an OSS alignment controller according to the present disclosure.

[0085] Referring to FIG. 14, an exemplary embodiment 20a of the OSS alignment controller 20 (FIG. 1) includes one or more processors 21, memory 22, user interface 23, network interface 24, and storage 26 interconnected via one or more system buses 25.

[0086] Each processor 21 may be any hardware device known in the art or contemplated below that is capable of executing instructions or processing data stored in memory 22 or storage. In non-limiting examples, processor 21 may include a microprocessor, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), or other similar device.

[0087] Memory 22 may include various memories known in the art or contemplated below, including, but not limited to, L1, L2, or L3 cache or system memory. In non-limiting examples, memory 22 may include static random access memory (SRAM), dynamic RAM (DRAM), flash memory, read-only memory (ROM), or other similar memory devices.

[0088] The user interface 23 may include one or more devices known in the art or contemplated below for enabling interaction with a user, such as an administrator. In some non-limiting examples, the user interface may include a command line interface or a graphical user interface that may be presented to a remote terminal via the network interface 24.

[0089] Network interface 24 may include one or more devices known in the art or contemplated below for enabling communication with an imaging system (not shown) and an additional tracking system (not shown) (e.g., an electromagnetic tracking system). In a non-limiting example, network interface 24 may include a network interface card (NIC) that communicates according to the Ethernet protocol. Furthermore, network interface 24 may implement a TCP / IP stack for communicating according to the TCP / IP protocol. Various alternative or additional hardware or configurations for network interface 26 will be apparent.

[0090] Storage 26 may include one or more machine-readable storage media known in the art or contemplated below, including, but not limited to, read-only memory (ROM), random-access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, or similar storage media. In various non-limiting embodiments, storage 26 may store instructions for execution by processor 21 or data on which processor 21 may act. For example, storage 26 may store a base operating system for controlling various basic operations of the hardware. Storage 26 may also store feature detector 28a and characteristic manager 28b as application modules in the form of executable software / firmware for implementing various functions of feature detection and alignment characteristic determination as described above in this disclosure. Storage 26 may also store an OSS interrogation application module (not shown) and / or an OSS reconstruction application module (not shown) known in the art or contemplated below. Storage 26 may also store lookup tables (e.g., predefined OTW shapes) as described above in this disclosure.

[0091] In practice, the OSS registration controller 20a can be incorporated into a standalone workstation (eg, a desktop, laptop, pad, or smartphone) or into a workstation or server of an OSS system.

[0092] 1-14 , those skilled in the art of the present disclosure will appreciate the many benefits of the present disclosure, including, but not limited to, automatically detecting characteristics of an OSS guidewire to automatically determine required OTW device alignment characteristics necessary for accurate and robust spatial tracking of an OTW device with an OSS guidewire or other tracking device, which is applicable to numerous and varied applications. The determined device characteristics may be used, but are not limited to, for invoking visualization properties, annotating the procedure, recording important information, documentation, or setting device / imaging properties to improve procedure accuracy.

[0093] Furthermore, the exemplary embodiments described in this disclosure teach how to detect features of an OSS guidewire to define device characteristics (e.g., catheter length) of an OTW device. Within the same principles as the present disclosure, features of an OSS guidewire can be detected to delineate the contours of an anatomical site. For example, a specific shape of an OSS guidewire (or an OSS guidewire and an OTW device) is caused by an anatomical site. The detected shape and anatomical site of the OSS guidewire (and the OTW device) can be stored in a predefined LUT. As a result, during a subsequent procedure, the detection of this feature facilitates determining the anatomical site or a specific type of procedure via the LUT.

[0094] Additionally, those skilled in the art will understand, in light of the teachings provided herein, that the structures, elements, components, etc. described in this disclosure / specification and / or shown in the figures may be implemented in various combinations of hardware and software and provide functionality that may be combined in a single element or multiple elements. For example, the functionality of the various structures, elements, components, etc. shown / illustrated / depicted in the figures may be provided using dedicated hardware as well as hardware capable of executing software in association with appropriate software for additional functionality. When provided by a processor, the functions may be provided by a single dedicated processor, a single shared processor, or multiple individual processors (some of which may be shared or multiplexed). Furthermore, explicit use of the terms "processor" or "controller" should not be construed to refer exclusively to hardware capable of executing software, but may implicitly include, without limitation, digital signal processor ("DSP") hardware, memory (e.g., read-only memory ("ROM"), random access memory ("RAM"), non-volatile storage for storing software, etc.), and virtually any means and / or machine (including hardware, software, firmware, combinations thereof, etc.) that can execute or control (or be configured to execute) or control a process.

[0095] Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Such equivalents are intended to include both currently known equivalents as well as equivalents developed in the future (e.g., elements developed to perform the same or substantially similar functions, regardless of structure). Thus, for example, those skilled in the art will appreciate, in light of the teachings provided herein, that any block diagrams presented herein may represent conceptual views of illustrative system components and / or circuitry embodying the principles of the invention. Similarly, those skilled in the art will appreciate, in light of the teachings provided herein, that any flowcharts, flow diagrams, etc., may be substantially represented in a computer-readable storage medium and, therefore, may represent various processes performed by a computer, processor, or other device having processing capability, whether or not such a device is explicitly shown.

[0096] Having described preferred and exemplary embodiments of the various and numerous inventions of the present disclosure (which embodiments are intended to be illustrative and not limiting), it should be noted that modifications and changes may occur to those skilled in the art in light of the teachings provided herein, including the figures. Accordingly, it should be understood that changes can be made in the preferred and exemplary embodiments of the present disclosure that are within the scope of the embodiments disclosed herein.

[0097] Corresponding and / or related systems incorporating and / or implementing or used / implemented in / with devices / systems in accordance with the present disclosure are also contemplated and contemplated to be within the scope of the present disclosure. Corresponding and / or related methods for manufacturing and / or using devices and / or systems in accordance with the present disclosure are also contemplated and contemplated to be within the scope of the present disclosure.

[0098] Other variations of the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure and the appended claims. In the claims, the word "comprises" does not exclude other elements or steps, and the singular does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. an optical shape-sensing guidewire movable within the over-the-wire device; an optical shape sensing alignment controller for controlling autonomous device alignment of the over-the-wire device; Including, The optical shape sensing alignment controller includes: automatically detecting at least one sensing feature of the optical shape sensing guidewire from optical shape sensing of the optical shape sensing guidewire in the over-the-wire device; and automatically identifying the over-the-wire device or a hub attached to the over-the-wire device from the automated detection of the at least one sensing feature of the optical shape-sensing guidewire; The optical shape sensing alignment controller includes: comparing the optical shape sensing of the movement of the optical shape sensing guidewire through the over-the-wire device to the shapes of each of a plurality of predefined over-the-wire devices; An optical shape sensing alignment system that selects one of the predefined over-the-wire instruments that has a best shape match to the optical shape sensing of the movement of the optical shape sensing guidewire through the over-the-wire instrument.

2. the hub includes a hub template; The optical shape sensing alignment controller includes: comparing the optical shape sensing of the movement of the optical shape sensing guidewire through the hub to a plurality of predefined hub templates; and The optical shape sensing alignment system of claim 1 , further comprising: selecting one of the predefined hub templates that has a best shape match to the hub template.

3. the plurality of predefined over-the-wire device shapes having predefined curves and associated lengths; The optical shape sensing alignment controller includes:

2. The optical shape sensing alignment system of claim 1, wherein the length of the over-the-wire device is determined from one of the plurality of predefined over-the-wire device shapes of the over-the-wire device that has a best shape match to the optical shape sensing of the movement of the optical shape sensing guidewire through the over-the-wire device.

4. 1. An optical shape sensing alignment controller for controlling autonomous device alignment of an over-the-wire device, comprising: a non-transitory machine-readable storage medium encoded with instructions for execution by at least one processor; The non-transitory machine-readable storage medium comprises: automatically detecting at least one sensing feature of the optical shape sensing guidewire from optical shape sensing of the optical shape sensing guidewire in the over-the-wire device; the instructions for automatically identifying the over-the-wire device or a hub attached to the over-the-wire device from the automated detection of the at least one sensing feature of the optical shape-sensing guidewire; The instructions for automatically identifying the over-the-wire device or a hub attached to the over-the-wire device include: comparing the optical shape sensing of the movement of the optical shape sensing guidewire through the over-the-wire device to the shapes of each of a plurality of predefined over-the-wire devices; an optical shape sensing alignment controller including instructions for selecting one of the predefined over-the-wire instruments having a best shape match to the optical shape sensing of the movement of the optical shape sensing guidewire through the over-the-wire instrument.

5. the hub includes a hub template; The instructions for automatically identifying the over-the-wire device or a hub attached to the over-the-wire device include: comparing the optical shape sensing of the movement of the optical shape sensing guidewire through the hub to a plurality of predefined hub templates; The optical shape sensing alignment controller of claim 4 including instructions for selecting one of the predefined hub templates that has a best shape match to the hub template.

6. the plurality of predefined over-the-wire device shapes having predefined curves and associated lengths; The optical shape sensing alignment controller includes:

5. The optical shape sensing alignment controller of claim 4, further comprising instructions for determining a length of the over-the-wire device from one of the plurality of predefined over-the-wire device shapes of the over-the-wire device having a best shape match to the optical shape sensing of the movement of the optical shape sensing guidewire through the over-the-wire device.

7. 1. An optical shape sensing alignment method executable by an optical shape sensing alignment controller for controlling autonomous instrument alignment of an over-the-wire instrument, comprising: controlling movement of an optical shape-sensing guidewire within the over-the-wire device; automatically detecting at least one sensing feature of the optical shape sensing guidewire from optical shape sensing of the optical shape sensing guidewire in the over-the-wire instrument via the optical shape sensing alignment controller; and automatically identifying the over-the-wire device or a hub attached to the over-the-wire device from the automated detection of the at least one sensing feature of the optical shape sensing guidewire via the optical shape sensing alignment controller; The step of automatically identifying the over-the-wire device or a hub attached to the over-the-wire device includes: comparing, via the optical shape sensing alignment controller, optical shape sensing of the movement of the optical shape sensing guidewire through the over-the-wire device with the shape of each of a plurality of predefined over-the-wire devices; and selecting, via the optical shape sensing alignment controller, one of the predefined over-the-wire instruments that has a best shape match to the optical shape sensing of the movement of the optical shape sensing guidewire through the over-the-wire instrument.

8. the hub includes a hub template; The step of automatically identifying the over-the-wire device or a hub attached to the over-the-wire device includes: comparing, via the optical shape sensing alignment controller, the optical shape sensing of the movement of the optical shape sensing guidewire through the hub with a plurality of predefined hub templates; selecting, via the optical shape sensing alignment controller, one of the predefined hub templates that has a best shape match to the hub template; The optical shape sensing alignment method of claim 7, comprising:

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