Shape sensing system with filter and method thereof

Abstract

Shape sensing system and method for medical device. The shape sensing system may include a medical device, an optical interrogator, a console, and a display screen. The medical device may include an integrated fiber optic probe having a fiber Bragg grating (FBG) sensor at least along its distal portion. The optical interrogator may be configured to send an input optical signal into the fiber optic probe and receive therefrom an optical signal reflected by the FBG sensor. The console may be configured to convert the reflected optical signal into plottable data by means of a filtering algorithm of some optical signal converter algorithm for displaying a plot thereof on a display screen. These plots may include plots of the curvature of each of the selected FBG sensors relative to time for identifying specific changes in strain of the fiber optic probe when the tip of the medical device is advanced into the superior vena cava of the patient.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 62 / 940,100, filed on November 25, 2019, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present application relates to a shape sensing system with a filter and a method thereof. Background Art

[0004] Sometimes, the tip of a peripherally inserted central catheter ("PICC") or central venous catheter ("CVC") can be displaced from an ideal position within a patient's superior vena cava ("SVC"). Clinicians who believe that such a PICC or CVC has displaced typically check for displacement via chest X-rays, and if necessary, replace the PICC or CVC. However, X-rays expose patients to ionizing radiation. Therefore, clinicians are required to easily and safely check for displacement of PICCs and CVCs to replace them when necessary.

[0005] This article discloses a shape sensing system with a filter and a method thereof for solving the above problems. Summary of the invention

[0006] A shape sensing system is disclosed herein. In some embodiments, the shape sensing system includes one or more medical devices, a console, and a display screen. The one or more medical devices include an integrated fiber optic probe and a heartbeat detection device for detecting a heartbeat sequence. The fiber optic probe has a plurality of fiber Bragg grating (FBG) sensors along the distal portion of the fiber optic probe. The console includes a memory and one or more processors. The console is configured to convert the heartbeat sequence into a heartbeat frequency through a heartbeat converter algorithm. The console is configured to convert the optical signal reflected from the FBG sensor of the fiber optic probe into plottable data through a plurality of optical signal converter algorithms. The optical signal converter algorithm includes a bandpass filtering algorithm for selecting the FBG sensor along the distal portion of the fiber optic probe. The bandpass filtering algorithm is configured to allow the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies within the frequency range around the heartbeat frequency to pass therethrough, while rejecting the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies outside the frequency range around the heartbeat frequency. The display screen is configured to display any of the multiple plots of the plottable data. The plurality of plots includes a plot of curvature of each of the selected FBG sensors versus time for identifying cyclical changes in strain of the fiber optic probe at the moment the tip of the fiber optic probe is advanced into the patient's heart.

[0007] In some embodiments, the optical signal converter algorithm includes a band-stop filtering algorithm for the FBG sensor proximal to the selected FBG sensor. The band-stop filtering algorithm is configured to reject optical signals or corresponding data reflected by the FBG sensor that appear at one or more frequencies within a frequency range around the heartbeat frequency, while passing optical signals or corresponding data reflected by the FBG sensor that appear at one or more frequencies outside the frequency range around the heartbeat frequency.

[0008] In some embodiments, the plurality of plots includes a displayable shape on a three-dimensional grid corresponding to the fiber optic probe in three-dimensional space. The displayable shape is substantially free of heartbeat-related fluid dynamic noise.

[0009] In some embodiments, the heartbeat detection device is incorporated into the same medical device as the medical device that includes the fiber optic probe.

[0010] In some embodiments, the same medical device including the fiber optic probe has electrocardiogram ("ECG") electrodes electrically connected by cables to an ECG component in the console for detecting heartbeat sequences.

[0011] In some embodiments, the same medical device including the fiber optic probe has one or more lumens configured to contain a saline solution. The medical device includes a cable that connects the one or more lumens to an ECG component in the console to detect a heartbeat sequence when filled with the saline solution.

[0012] In some embodiments, the heartbeat detection device is incorporated into a medical device different from the medical device that includes the fiber optic probe.

[0013] In some embodiments, the various medical devices include ECG skin electrodes electrically connected to an ECG component in the console for detecting heartbeat sequences.

[0014] In some embodiments, the console includes a heart determiner algorithm configured to automatically confirm on the display that the tip of the fiber optic probe is in the patient's heart by means of cyclical changes in strain of the fiber optic probe sensed by the selected FBG sensor. The cyclical changes in strain are caused by fluid dynamics associated with the heartbeat.

[0015] In some embodiments, the shape sensing system further comprises an optical interrogator configured to send an input optical signal into the optical fiber probe and receive an optical signal reflected by the FBG sensor from the optical fiber probe. The optical interrogator is a stand-alone optical interrogator or an integrated optical interrogator integrated into the console.

[0016] Also disclosed herein is a method of a shape sensing system, in some embodiments, the method includes a shape sensing step of performing shape sensing using an optical fiber probe of a shape sensing system as the tip of the optical fiber probe is advanced through the vascular system of a patient toward the heart. The optical fiber probe has a plurality of FBG sensors for shape sensing along a distal portion of the optical fiber probe. The method also includes a detection step of detecting a heartbeat sequence using a heartbeat detection device of the shape sensing system, for detecting a heartbeat sequence as the tip of the optical fiber probe is advanced through the vascular system of the patient toward the heart. The method further includes a first conversion step of converting the heartbeat sequence to a heartbeat frequency by a heartbeat converter algorithm of a console of the shape sensing system.

[0017] The method further includes a second conversion step of converting the optical signals reflected from the FBG sensors received from the optical fiber probe into plottable data by a plurality of optical signal converter algorithms of the console. The second conversion step includes, for the selected FBG sensors along the distal portion of the optical fiber probe, passing the optical signals reflected from the FBG sensors or the corresponding data through a bandpass filtering algorithm in the optical signal converter algorithm. The bandpass filtering algorithm is configured to pass the optical signals reflected from these FBG sensors or the corresponding data therethrough, for selecting FBG sensors that appear at one or more frequencies within a frequency range around the heartbeat frequency, while rejecting the optical signals reflected from the FBG sensors or the corresponding data that appear at one or more frequencies outside the frequency range around the heartbeat frequency. The method also includes a plotting step of plotting a plurality of plots including a plot of the curvature of each FBG sensor of the selected FBG sensors with respect to time on a display screen of the shape sensing system. The method also includes a displaying step of displaying, at the moment when the tip of the optical fiber probe is advanced into the heart of the patient, a periodic change in strain in the plot of the curvature of any FBG sensor of the selected FBG sensor with respect to time on the display screen.

[0018] In some embodiments, the second conversion step includes passing the optical signal or corresponding data reflected by the FBG sensor proximal to the selected FBG sensor through a band-stop filtering algorithm in the optical signal converter algorithm. The band-stop filtering algorithm is configured to reject the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies within the frequency range around the heartbeat frequency, while passing the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies outside the frequency range around the heartbeat frequency.

[0019] In some embodiments, the plurality of plots includes displayable shapes on a three-dimensional grid corresponding to the fiber optic probe in three-dimensional space. The displayable shapes are substantially free of heartbeat-related fluid dynamic noise.

[0020] In some embodiments, the heartbeat detection device comprises ECG electrodes of a medical device comprising a fiber optic probe connected to an ECG component in a console, ECG skin electrodes, or a combination thereof for detecting a heartbeat sequence.

[0021] In some embodiments, the method further comprises a signal sending step and a signal receiving step, wherein the signal sending step sends the input optical signal to the optical fiber probe through an optical interrogator, and the signal receiving step receives the optical signal reflected by the FBG sensor from the optical fiber probe through the optical interrogator. The optical interrogator is a stand-alone optical interrogator or an integrated optical interrogator integrated into the console.

[0022] Also disclosed herein is a method for determining that the tip of a medical device is located within the heart, in some embodiments, the method includes a propulsion step of advancing the tip of the medical device through the patient's vascular system toward the heart. The medical device includes an integrated fiber optic probe having a plurality of FBG sensors along a distal portion of the fiber optic probe for shape sensing using a shape sensing system including the medical device. The method also includes a detection step of detecting a heartbeat sequence using a heartbeat detection device of the shape sensing system, the heartbeat detection device being used to detect a heartbeat sequence when the tip of the medical device is advanced through the patient's vascular system toward the heart. The method further includes a first allowing step of allowing the heartbeat sequence to be converted to a heartbeat frequency by a heartbeat converter algorithm of a console of the shape sensing system.

[0023] The method further includes a second allowing step, which allows the optical signal reflected from the FBG sensor received from the optical fiber probe when the tip of the medical device is advanced through the vascular system of the patient to be converted into plottable data through multiple optical signal converter algorithms of the console. The optical signal converter algorithm includes a bandpass filtering algorithm for selecting the FBG sensor along the distal portion of the optical fiber probe. The bandpass filtering algorithm is configured to pass the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies within the frequency range around the heartbeat frequency, while rejecting the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies outside the frequency range around the heartbeat frequency. The method also includes a third allowing step, allowing a plurality of plots including a plot of the curvature of each FBG sensor of the selected FBG sensor relative to time to be drawn on the display screen of the shape sensing system. The method also includes an identification step: identifying on the display screen a periodic change in strain in the plot of the curvature of any FBG sensor of the selected FBG sensor relative to time at the moment when the tip of the medical device is advanced into the heart of the patient, thereby determining that the tip of the medical device is located within the heart.

[0024] In some embodiments, the optical signal converter algorithm includes a band-stop filtering algorithm for the FBG sensor proximal to the selected FBG sensor. The band-stop filtering algorithm is configured to reject FBG sensor reflected light signals or corresponding data that appear at one or more frequencies within a frequency range around the heartbeat frequency, while allowing FBG sensor reflected light signals or corresponding data that appear at one or more frequencies outside the frequency range around the heartbeat frequency to pass therethrough.

[0025] In some embodiments, the plurality of plots includes displayable shapes on a three-dimensional grid corresponding to the fiber optic probe in three-dimensional space. The displayable shapes are substantially free of heartbeat-related fluid dynamic noise.

[0026] In some embodiments, the heartbeat detection device includes ECG electrodes of a medical device connected to an ECG component in a console, ECG skin electrodes, or a combination thereof for detecting a heartbeat sequence.

[0027] In some embodiments, the advancing step comprises advancing the tip of the medical device through the right internal jugular vein, the right brachiocephalic vein, and into the SVC.

[0028] In some embodiments, the fiber optic probe is positioned in a central venous catheter ("CVC").

[0029] In some embodiments, the advancing step includes advancing the tip of the medical device through the right basilar vein, the right axillary vein, the right subclavian vein, the right brachiocephalic vein and into the SVC.

[0030] In some embodiments, the medical device is a peripherally inserted central catheter ("PICC").

[0031] In some embodiments, the method further comprises a stopping step of ceasing to advance the tip of the medical device through the vasculature of the patient after determining that the tip of the medical device is located in the heart.

[0032] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in greater detail certain embodiments of these concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 is a block diagram of a first shape sensing system according to some embodiments.

[0034] Figure 2 is a block diagram of a second shape sensing system according to some embodiments.

[0035] Figure 3 A second shape sensing system is shown in accordance with some embodiments.

[0036] Figure 4AA cross-section of a catheter conduit of a medical device is shown, according to some embodiments.

[0037] Figure 4B A longitudinal cross-section of a catheter conduit of a medical device is shown according to some embodiments.

[0038] Figure 5 A detailed cross-section of a fiber optic connector module is shown in accordance with some embodiments.

[0039] Figure 6 A second shape sensing system having a first fiber optic connector module is shown in accordance with some embodiments.

[0040] Figure 7 A second shape sensing system is shown having a first fiber optic connector module positioned within a fenestration of a surgical drape in accordance with some embodiments.

[0041] Figure 8 A second shape sensing system having a second fiber optic connector module is shown in accordance with some embodiments.

[0042] Fig. 9 A second shape sensing system is shown having a second fiber optic connector module located beneath the surgical drape in accordance with some embodiments.

[0043] Fig.10 A number of different plots on a display screen of a shape sensing system according to some embodiments are provided.

[0044] Fig.11 Provided as Fig.10 One of the plots is a detailed plot of curvature versus arc length and torsion versus arc length of at least a distal portion of a fiber optic probe.

[0045] Fig.12 Provided as Fig.10 A detailed plot of the angle of at least a distal portion of one of the fiber optic probes relative to the arc length.

[0046] Fig.13 Provided as Fig.10 The plot is a detailed plot of the position of at least a distal portion of one of the fiber optic probes with respect to time.

[0047] Fig.14 A displayable shape of at least a distal portion of a medical device or fiber optic probe according to some embodiments is provided.

[0048] Fig.15 A detailed plot of the curvature versus time for each FBG sensor selected from a plurality of fiber probe FBG sensors is provided, as Fig.10 Some drawings of . DETAILED DESCRIPTION

[0049] 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 easily separated from the specific embodiments and optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0050] About the terms used in this article, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein. Ordinal numbers (such as first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide series or numerical restrictions. For example, "first", "second" and "third" features or steps do not have to appear in order, and the specific embodiments including these features or steps do not have to be limited to these three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "back" are used, and it is not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such marks are used to reflect, for example, relative position, orientation or direction. Unless the context clearly stipulates otherwise, the singular "a (a)", "an (an)" and "the" include plural references.

[0051] For example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter that is expected to be close to the clinician's catheter when the catheter is used for a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is expected to be close to the clinician's catheter when the catheter is used for a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is expected to be close to the clinician's catheter when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal portion, or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0052] "Distal side", "distal portion" or "distal end" of a catheter disclosed herein, for example, includes the portion of the catheter that is expected to be near the patient or in the patient when the catheter is used in the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is expected to be near the patient or in the patient when the catheter is used in the patient. For example, the "distal end" of a catheter includes the end of the catheter that is expected to be near the patient or in the patient when the catheter is used in the patient. The distal portion, distal portion or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal portion or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal portion or distal length of a catheter is not the terminal portion or terminal length of a catheter.

[0053] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0054] As described above, there is a need for clinicians to easily and safely check for displacement of PICCs and CVCs to replace the PICCs and CVCs when necessary. A shape sensing system with a filter and a method thereof that solves the above problems are disclosed herein.

[0055] For example, in some embodiments, the shape sensing system includes one or more medical devices, which include an integrated fiber optic probe and a heartbeat detection device for detecting a heartbeat sequence, a console, and a display screen. The fiber optic probe has a plurality of FBG sensors along the distal portion of the fiber optic probe. The console includes a memory and one or more processors. The console is configured to convert the heartbeat sequence into a heartbeat frequency through a heartbeat converter algorithm. The console is configured to convert the optical signal reflected from the FBG sensor of the fiber optic probe into plottable data through a plurality of optical signal converter algorithms. The optical signal converter algorithm includes a bandpass filtering algorithm for selecting the FBG sensor along the distal portion of the fiber optic probe. The bandpass filtering algorithm is configured to pass the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies within the frequency range around the heartbeat frequency, while rejecting the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies outside the frequency range around the heartbeat frequency. The display screen is configured to display any of the multiple plots of the plottable data. The plots include a plot of curvature versus time for each of the selected FBG sensors for identifying periodic changes in strain of the fiber optic probe at the moment the tip of the fiber optic probe is advanced into the patient's heart.

[0056] These and other features of the shape sensing system and method with a filter provided herein will become more apparent with reference to the accompanying drawings and the following description, which provide specific embodiments of the shape sensing system and method with a filter in greater detail.

[0057] Shape Sensing System

[0058] Figure 1 is a block diagram of a first shape sensing system 100 according to some embodiments. Figure 2 is a block diagram of a second shape sensing system 200 according to some embodiments. Figure 3 A second shape sensing system 200 is shown in accordance with some embodiments. Fig.10 A display screen 150 or 250 of a shape sensing system 100 or 200 according to some embodiments is provided. Figure 11-15 Provided in Fig.10 A detailed drawing of multiple different drawings on the display screen 150 or 250.

[0059] As shown, shape sensing system 100 includes at least medical device 110, stand-alone optical interrogator 130, console 140, and display screen 150 such as a stand-alone monitor. Shape sensing system 200 includes medical device 110, integrated optical interrogator 230, console 240, and display screen 250, wherein both integrated optical interrogator 230 and display screen 250 are integrated into console 240. Each of these shape sensing systems 100 and 200 may further include a fiber optic connector module 120 configured to connect medical device 110 to the remainder of shape sensing system 100 or 200 (e.g., optical interrogator 130 or console 240 including integrated optical interrogator 230).

[0060] As described in more detail below, the medical device 110 includes an integrated fiber optic probe having a plurality of FBG sensors along at least a distal portion of the fiber optic probe for shape sensing using the shape sensing system 100 or 200 (see for examples of fiber optic probes of the medical device 110). Figure 4B The medical device 110 of the shape sensing system 100 or 200 or a different medical device may include a heartbeat detection device for detecting a heartbeat sequence.

[0061] With respect to a particular embodiment of a medical device 110, such as a PICC 310, certain features of the medical device 110 are set forth in more detail below. Nevertheless, some features set forth below with respect to one or more embodiments of the medical device 110 are shared between two or more embodiments of the medical device 110. Likewise, as needed for ease of description, "medical device 110" as used herein generally refers to more than one embodiment of the medical device 110. Although certain features have been described with respect to a particular embodiment of a medical device 110, such as a PICC 310, this still applies.

[0062] Although only console 240 is shown, each of consoles 140 and 240 includes one or more processors 242 and memory 244, which include multiple algorithms 246, such as one or more optical signal converter algorithms including a bandpass filtering algorithm or a bandstop filtering algorithm, and a heartbeat converter algorithm. The one or more optical signal converter algorithms are configured to convert the reflected optical signal from the optical fiber probe of the medical device 110 into drawable data for multiple plots of the drawable data. The one or more optical signal converter algorithms are also configured to convert the optical signal reflected from the FBG sensor of the optical fiber probe of the medical device 110 into drawable data corresponding to the displayable shape of the medical device 110. The display screen 150 or 250 is configured to display the displayable shape of the medical device 110 on the three-dimensional grid 1002 representing the three-dimensional space, as well as any drawing of the number of drawings of other drawable data.

[0063] The plots may include a plot 1004 of curvature versus arc length, a plot 1006 of torsion versus arc length, a plot 1008 of angle versus arc length, or a plot 1010 of position versus time of at least the distal portion of the fiber optic probe. For each of the selected FBG sensors in the distal portion of the fiber optic probe, the plots may further include at least a plot 1012a, 1012b, 1012c, ..., 1012n of curvature versus time. For the selected FBG sensor in the distal portion of the fiber optic probe, any one or more of the plots 1012a, 1012b, 1012c, ..., 1012n of curvature versus time may be used to manually identify specific changes in strain of the fiber optic probe by plotting specific changes in the curvature of the fiber optic probe as the tip of the medical device 110 is advanced into the patient's heart. However, Fig.10 and Fig.15 The three plots of curvature versus time shown in 1012a, 1012b, and 1012c are plots of the last three FBG sensors in the distal portion of the fiber optic probe. The last three FBG sensors in the distal portion of the fiber optic probe are particularly useful in identifying specific changes in the curvature of the plotted fiber optic probe because the aforementioned FBG sensors directly experience the physical changes in curvature caused by the tensile and compressive strains of the fiber optic probe as the tip of the medical device 110 is advanced into the patient's heart. The specific change in the plotted curvature of the plotted fiber optic probe is illustrated by a transient increase in the plotted curvature followed by a transient decrease in the plotted curvature, the magnitude of the specific change in the plotted curvature being approximately twice the transient increase in the plotted curvature, as shown in FIG. Fig.15 The curvature shown in FIG. 1012 is shown by the arrows in any of the plots 1012a , 1012b , or 1012c with respect to time.

[0064] In addition to being able to use any one or more of the curvature versus time plots to manually identify specific changes in strain of the fiber optic probe at the moment the tip of the medical device 110 is advanced into the patient's heart, for a selection of an FBG sensor in the distal portion of the fiber optic probe, any one or more of the curvature versus time plots 1012a, 1012b, 1012c, ..., 1012n can also be used to manually confirm that the tip of the medical device 110 is in the heart by periodic changes in strain of the fiber optic probe. The periodic changes in fiber optic probe strain are evidenced by periodic changes in the plotted curvature of the fiber optic probe sensed by the selected FBG sensor (see Fig.10 and Fig.15 Three plots 1012a, 1012b, and 1012c of curvature versus time are shown between about 860s and 1175s when the distal portion of the fiber optic probe remains in position in the heart, as shown in the position versus time plot 1010). The periodic variations in the plotted curvature are caused by periodic variations in blood flow within the heart as sensed by the selected FBG sensor as the patient's heart beats.

[0065] The periodic changes in strain sensed by any of the selected FBG sensors in the distal portion of the fiber optic probe are relatively small changes. As a result, the periodic changes in curvature plotted for any of the selected FBG sensors are also relatively small changes. Because such relatively small changes can be easily overwhelmed, filtering out strain experienced by the selected FBG sensors rather than strain caused by periodic changes in blood flow within the heart can help enhance the periodic changes in the plotted curvature for the selected FBG sensors.

[0066] As described above, one or more optical signal converter algorithms in the plurality of algorithms 246 include a bandpass filtering algorithm configured to facilitate identification of periodic changes in strain sensed by the fiber optic probe, specifically, strain sensed by any of the selected FBG sensors at the moment when the tip of the fiber optic probe is advanced into the heart of the patient. One or more optical signal converter algorithms in the plurality of algorithms 246 also include a bandstop filtering algorithm configured to support display of a displayable shape corresponding to the medical device 110 on the three-dimensional grid 1002 representing the three-dimensional space. In fact, the bandstop filtering algorithm is configured to support display of the displayable shape so that the displayable shape is substantially unaffected by heartbeat-related fluid dynamics or noise thereof. Each of the bandpass filtering algorithm and the bandstop filtering algorithm depends in part on a heartbeat frequency, which can be obtained from the patient by a heartbeat detection device for detecting a heartbeat sequence and a heartbeat converter algorithm for converting the heartbeat sequence into a heartbeat frequency.

[0067] The heartbeat detection device can be incorporated into the same medical device as the medical device including the fiber optic probe, i.e., the medical device 110, or incorporated into a medical device different from the medical device including the fiber optic probe. For the same medical device as the medical device including the fiber optic probe, the heartbeat detection device can include an ECG probe arranged in the medical device 110 or an ECG electrode of the medical device 110 electrically connected to the ECG component in the console 140 or 240 by a cable for detecting a heartbeat sequence. Alternatively, the heartbeat detection device can include one or more lumens of the medical device 110, which are configured to accommodate a saline solution according to the so-called saline technique, wherein a saline solution column contained in the catheter is used as an intracavitary electrode. In such an embodiment, the medical device 110 can include a cable that connects the one or more lumens to the ECG component in the console 140 or 240 when filled with a saline solution for detecting a heartbeat sequence. For a medical device other than the one including the fiber optic probe, the heartbeat detection device may include ECG skin electrodes electrically connected to an ECG component in the console 140 or 240 for detecting a heartbeat sequence.

[0068] The console 140 or 240 is configured to convert the heartbeat sequence detected by the heartbeat detection device into an instantaneous heartbeat frequency through a heartbeat converter algorithm in the plurality of algorithms 246, which heartbeat frequency can then be used by a bandpass filtering algorithm, a bandstop filtering algorithm, or both. The heartbeat sequence can be constant over time relative to a diastolic point or a systolic point in the heartbeat sequence, increase over time relative to a diastolic point or a systolic point in the heartbeat sequence, decrease over time relative to a diastolic point or a systolic point in the heartbeat sequence, or some combination thereof. Similar to the heartbeat sequence from which the heartbeat frequency is obtained, the heartbeat frequency can be constant, increase over time, decrease over time, or some combination thereof.

[0069] The console 140 or 240 is configured to convert the reflected optical signal from the optical fiber probe of the medical device 110 into plottable data using the instantaneous heartbeat frequency provided by the heartbeat converter algorithm through a bandpass filtering algorithm in one or more optical signal converter algorithms. The bandpass filtering algorithm is configured to pass the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies within the frequency range around the heartbeat frequency, while rejecting the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies outside the frequency range around the heartbeat frequency. Filtering the optical signal or corresponding data reflected by the FBG sensor using the bandpass filtering algorithm helps to identify the periodic changes in the strain sensed by the optical fiber probe, especially the strain sensed by any of the selected FBG sensors, at the moment when the tip of the medical device 110 or its optical fiber probe is advanced into the patient's heart. As described above, because such relatively small changes can be easily drowned out, by filtering out the strain experienced by the selected FBG sensor rather than the strain caused by the periodic changes in the strain, it can help to enhance the periodic changes in the plotted curvature for the selected FBG sensor.

[0070] The console 140 or 240 is further configured to convert the reflected optical signal from the fiber optic probe of the medical device 110 into plottable data using the instantaneous heartbeat frequency provided by the heartbeat converter algorithm through a band-stop filtering algorithm in one or more optical signal converter algorithms. The band-stop filtering algorithm is configured to reject the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies within the frequency range around the heartbeat frequency, while passing the FBG sensor reflected optical signal or corresponding data that appears at one or more frequencies outside the frequency range around the heartbeat frequency. Filtering the FBG sensor reflected optical signal or corresponding data with the band-stop filtering algorithm supports displaying a displayable shape corresponding to the medical device 110 on the three-dimensional grid 1002 representing the three-dimensional space, in particular, the fiber optic probe of the medical device 110 or a portion of the medical device 110 having the FBG sensor proximal to the selected FBG sensor. In fact, the band-stop filtering algorithm is configured to support displaying the displayable shape so that the displayable shape is substantially unaffected by heartbeat-related fluid dynamics or noise thereof.

[0071] In some embodiments, the bandpass filtering algorithm is configured to filter the optical signal or corresponding data reflected by the FBG sensor for selecting the FBG sensor (e.g., the last three FBG sensors) in the distal portion of the optical fiber probe, while the bandstop filtering algorithm is configured to filter the optical signal or corresponding data reflected by the FBG sensor of the FBG sensor close to the aforementioned selected FBG sensor. In this way, the bandpass filtering algorithm facilitates the identification of the periodic changes in the strain sensed by any FBG sensor of the selected FBG sensor in the distal portion of the optical fiber probe, while the bandstop filtering algorithm supports the display of the displayable shape corresponding to the remaining portion of the medical device 110 proximal to the selected FBG sensor.

[0072] Each of consoles 140 and 240 may further include a cardiac determiner algorithm in one or more algorithms 246 configured to automatically determine a specific change in strain of the fiber optic probe as the tip of the medical device 110 is advanced into the patient's heart by a specific change in the plotted curvature of the fiber optic probe or plottable data thereof. Again, the specific change in the plotted curvature is a momentary increase in the plotted curvature followed by a momentary decrease in the plotted curvature having a magnitude approximately twice that of the momentary increase in the plotted curvature. The cardiac determination algorithm may also be configured to confirm that the tip of the medical device 110 is in the heart by automatically determining periodic changes in the plotted curvature of the fiber optic probe sensed by the selected FBG sensor (see Fig.10 and Fig.15 Three plots 1012a, 1012b and 1012c of curvature versus time are shown, between about 860 s and 1175 s, when the distal portion of the fiber optic probe is maintained in position in the heart, as shown in the position versus time plot 1010). The periodic changes in the plotted curvature are caused by the heartbeat-related fluid dynamics or periodic changes in blood flow within the heart, which are sensed by the selected FBG sensor as the patient's heart beats.

[0073] The optical interrogator 130 or 230 is configured to send an input optical signal to the optical fiber probe of the medical device 110 and receive a reflected optical signal from the optical fiber probe. When the optical fiber connector module 120 is present in the shape sensing system 100 or 200, the optical interrogator 130 or 230 is configured to send an input optical signal to the optical fiber probe of the medical device 110 via the optical fiber connector module 120 and receive a reflected optical signal from the optical fiber probe via the optical fiber connector module 120.

[0074] The fiber optic connector module 120 includes a housing 324, a cable 326 extending from the housing 324, and at least an optical fiber 528 in the cable 326 (for the optical fiber 528, see Figure 5 ). The fiber optic connector module 120 is configured to establish a first optical connection between the fiber optic probe of the medical device 110 and the optical fiber 528 of the fiber optic connector module 120. The fiber optic connector module 120 is also configured with a plug 330 at the end of the cable 326 to establish a second optical connection between the optical fiber 528 of the fiber optic connector module 120 and the optical interrogator 130 or 230. The optical fiber 528 of the fiber optic connector module 120 is configured to transmit an input optical signal from the optical interrogator 130 or 230 to the fiber optic probe of the medical device 110 and transmit a reflected optical signal by the fiber optic probe to the optical interrogator 130 or 230.

[0075] The fiber optic connector module 120 may further include one or more sensors 222 selected from at least a gyroscope, an accelerometer, and a magnetometer disposed within the housing 324. The one or more sensors 222 are configured to provide sensor data to the console 140 or 240 via at least one or more data lines within the cable 326 so as to determine a reference plane using a reference plane determiner algorithm in the one or more algorithms 246 for shape sensing using the fiber optic probe of the medical device 110.

[0076] Certain features of the fiber optic connector module 120 will be described in more detail below with respect to specific embodiments of the fiber optic connector module 120, such as the fiber optic connector modules 620 and 820. Nevertheless, some features described below with respect to one or more embodiments of the fiber optic connector module 120 are shared between two or more embodiments of the fiber optic connector module 120. Therefore, as used herein, "fiber optic connector module 120" generally refers to more than one embodiment of the fiber optic connector module 120 when necessary for ease of description. Although certain features have been described with respect to specific embodiments of the fiber optic connector module 120, such as the fiber optic connector modules 620 and 820, this still applies.

[0077] Medical Devices

[0078] Figure 3 Also shown is a PICC 310 as the medical device 110 according to some embodiments. Figure 4A A cross-section of catheter tubing 312 of PICC 310 including an integrated fiber optic probe 424 is shown in accordance with some embodiments. Figure 4B A longitudinal cross-section of a catheter conduit 312 of a PICC 310 including an integrated fiber optic probe 424 is shown, according to some embodiments.

[0079] As shown, PICC 310 comprises a catheter conduit 312, a bifurcated hub 314, two extension legs 316 and two Luer connectors 318 operably connected in the above order. The catheter conduit 312 comprises two catheter lumens 413 and an optical fiber probe 424, which is extruded and arranged in a longitudinal bead 425 of the catheter conduit 312, such as between the two catheter lumens 413. Optionally, in the same or different longitudinal beads of the catheter conduit 312, the PICC 310 may further include an ECG probe or ECG electrode electrically connected to an ECG component in the console 140 or 240 by a cable for detecting a heartbeat sequence. The bifurcated hub 314 has two hub lumens correspondingly fluidically connected to the two catheter lumens 413. Each extension leg of the two extension legs 316 has an extension leg lumen fluidically connected to the hub lumen of the two hub lumens. The PICC 310 also includes a probe extension tube 320 extending from the bifurcated hub 314. The probe extension tube 320 can be a thinned portion of the catheter conduit 312 including the fiber optic probe 424 or a thinned portion of the catheter conduit 312 arranged in another tube, either of which can terminate in a plug 322 for establishing an optical connection between the optical fiber 528 of the fiber optic connector module 120 and the fiber optic probe 424 of the PICC 310.

[0080] The fiber optic probe 424 includes a plurality of FBG sensors 426a, 426b, 426c ..., 426n along at least a distal portion of the fiber optic probe 424, which are configured for shape sensing using the shape sensing system 100 or 200. The FBG sensors 426a, 426b, 426c ..., 426n include periodic variations in the refractive index of the optical fiber of the fiber optic probe 424, thereby forming a specific wavelength reflector configured to reflect an input optical signal sent by the optical interrogator 130 or 230 into the fiber optic probe 424. In particular, Figure 4B The last three FBG sensors 426a, 426b, and 426c in the distal portion of the fiber-optic probe 424 are shown and are particularly effective in identifying specific changes or periodic changes in the plotted curvature of the fiber-optic probe 424 as described above. This is because in this case, the last three FBG sensors 426a, 426b, and 426c directly experience the physical changes in the curvature of the fiber-optic probe 424 as the tip of the PICC 310 is advanced into the patient's heart via, for example, the SVC.

[0081] Although PICC 310 is provided as a specific embodiment of the medical device 110 of the shape sensing system 100 or 200, it should be understood that any of a plurality of medical devices including a catheter such as a CVC may include at least a fiber optic probe and a probe extension tube in the PICC 310, which terminates in a plug for establishing an optical connection between the fiber optic probe of the medical device and the optical interrogator 130 or 230, optionally via the optical fiber 528 of the fiber optic connector module 120.

[0082] Fiber Optic Connector Module

[0083] Figure 6 A second shape sensing system 200 is shown having a first fiber optic connector module 620 in accordance with some embodiments. Figure 7 A second shape sensing system 200 is shown having a first fiber optic connector module 620 within a fenestration 601 of a surgical drape 603 in accordance with some embodiments. Figure 8 A second shape sensing system 200 is shown having a second fiber optic connector module 820 in accordance with some embodiments. Fig. 9 A second shape sensing system 200 is shown having a second fiber optic connector module 820 beneath a surgical drape 603 in accordance with some embodiments. Figure 5 A detailed cross-section of a fiber optic connector module 120, such as the first fiber optic connector module 620 or the second fiber optic connector module 820, is shown according to some embodiments thereof.

[0084] As shown, the fiber optic connector module 620 or 820 includes a housing 324 , a receptacle 532 disposed in the housing 324 , a cable 326 extending from the housing 324 , and at least an optical fiber 528 within the cable 326 .

[0085] The socket 532 includes an optical receiver configured to receive insertion of an optical terminal of a plug of the medical device 110 (e.g., the plug 322 of the PICC 310) for establishing an optical connection between the fiber optic connector module 620 or 820 and the fiber optic probe of the medical device 110 (e.g., the fiber optic probe 424 of the PICC 310) when the plug is inserted into the socket 532. The cable 326 includes a plug 330 for establishing an optical connection between the fiber optic connector module 620 or 820 and the optical interrogator 230 of the console 240.

[0086] Optical fiber 528 extends from receptacle 532 through cable 326 to plug 330. Optical fiber 528 is configured to transmit input optical signals from optical interrogator 230 to a fiber optic probe of medical device 110 (e.g., fiber optic probe 424 of PICC 310) and transmit reflected optical signals from the fiber optic probe to optical interrogator 230.

[0087] As described above, the fiber optic connector module 620 or 820 may further include one or more sensors 222 selected from a gyroscope, an accelerometer, and a magnetometer disposed within the housing 324. The one or more sensors 222 are configured to provide sensor data for determining a reference plane, thereby determining a reference plane for shape sensing using a fiber optic probe of the medical device 110 (e.g., the fiber optic probe 424 of the PICC 310).

[0088] Although not shown, the fiber optic connector module 620 or 820 may further include power and data lines extending from the one or more sensors 222 to the plug 330 or another plug through the cable 326. When the one or more sensors 122 are present in the fiber optic connector module 620 or 820, the power and data lines are configured to transmit power to the one or more sensors 122 and transmit data from the one or more sensors 122 to the console 240, respectively.

[0089] The fiber optic connection module 620 is configured to be located within the fenestration 601 of the surgical drape 603, adjacent to a percutaneous insertion site for the medical device 110 (e.g., a catheter such as a PICC 310). Because the fiber optic connection module 620 is configured to be located within the fenestration 601 of the surgical drape 603, the fiber optic connection module 620 is suitable for disinfection or sterilization. For example, the housing 324 of the fiber optic connection module 620 can be non-porous or chemically resistant to oxidizing agents. The fiber optic connection module 620 can be configured to use a fiber optic connection module manufactured by Becton, Dickinson and Company (located in Franklin Lakes, New Jersey). The product can be manually sterilized, or the fiber optic connection module 620 can be configured to be sterilized by using Nanosonics Inc. (located in Indianapolis, Indiana). The product uses vaporized H 2 O 2 Perform automatic high-intensity disinfection or sterilization.

[0090] Compared to the fiber optic connection module 620 , the fiber optic connection module 820 is configured to be located below the surgical drape 603 on the chest of the patient P. As such, the fiber optic connection module 820 does not require the same level of disinfection or sterilization as the fiber optic connection module 620 .

[0091] Although not shown, the housing 324 of the fiber optic connection module 820 includes a ring extending from the housing 324, a tether point integrated into the housing 324, a ball locking bolt receiver integrated into the housing 324, etc., which is configured for attaching a neck strap to the fiber optic connector module 820. The ring, tether point, ball locking bolt receiver, etc. enable the fiber optic connector module 820 to be secured to the neck of the patient P when it is on the patient's chest. Additionally or alternatively, the housing 324 includes a patient-facing surface (e.g., the back of the fiber optic connection module 820) that is configured to adhere to the patient's chest. The patient-facing surface enables the fiber optic connector module 820 to be secured to the patient's chest when it is on the patient's chest, regardless of whether the fiber optic connection module 820 is also secured to the patient's neck.

[0092] Likewise, the socket 532 includes an optical receiver configured to receive insertion of an optical terminal of a plug of the medical device 110 (e.g., the plug 322 of the PICC 310) and to form an optical connection when the plug is inserted into the socket 532; however, an optical connection to the surgical drape 603 is formed between the optical fiber connector module 820 and the medical device 110 using the optical fiber connector module 820. The socket 532 and the plug of the medical device 110 achieve an optical connection at least from a sterile area including the medical device 110 (e.g., PICC 310) (e.g., above the surgical drape 603) to a non-sterile area including the optical fiber connection module 820 (e.g., below the surgical drape 603) by rupturing the surgical drape 603.

[0093] method

[0094] The method of shape sensing system 100 or 200 includes a shape sensing step in which shape sensing is performed using a fiber optic probe (eg, fiber optic probe 424 ) of shape sensing system 100 or 200 as the tip of a medical device 110 or fiber optic probe is advanced through the patient's vasculature toward the heart.

[0095] The method further comprises a detection step of detecting a heartbeat sequence using a heartbeat detection device of the shape sensing system 100 or 200 for detecting a heartbeat sequence when the tip of the medical device 110 of its fiber optic probe is advanced through the patient's vasculature toward the heart.

[0096] The method further includes a signal sending step of sending an input optical signal into the optical fiber probe through the optical interrogator 130 or 230 and a signal receiving step of receiving an optical signal reflected by the FBG sensor from the optical fiber probe through the optical interrogator 130 or 230 .

[0097] The method further includes a first conversion step of converting the heartbeat sequence into a heartbeat frequency by a heartbeat converter algorithm of the console 140 or 240 of the shape sensing system 100 or 200 .

[0098] The method further includes a second conversion step of converting the optical signal reflected by the FBG sensor received from the optical fiber probe into plottable data by a plurality of optical signal converter algorithms of the console 140 or 240 .

[0099] The second conversion step may include passing the optical signal reflected by the FBG sensor or the corresponding data through a bandpass filtering algorithm in the optical signal converter algorithm for selecting the FBG sensor along the distal portion of the optical fiber probe. As described above, the bandpass filtering algorithm is configured to pass the optical signal reflected by the FBG sensor or the corresponding data therethrough for selecting the FBG sensor that appears at one or more frequencies within a frequency range around the heartbeat frequency, while rejecting the optical signal reflected by the FBG sensor or the corresponding data that appears at one or more frequencies outside the frequency range around the heartbeat frequency.

[0100] The second conversion step may include, for the FBG sensor proximal to the selected FBG sensor, passing the optical signal reflected by the FBG sensor or the corresponding data through a band-stop filtering algorithm of the optical signal converter algorithm. The band-stop filtering algorithm is configured to reject the optical signal reflected by the FBG sensor or the corresponding data that appears at one or more frequencies within the frequency range around the heartbeat frequency, while passing the optical signal reflected by the FBG sensor or the corresponding data that appears at one or more frequencies outside the frequency range around the heartbeat frequency.

[0101] The method also includes a drawing step that draws a plurality of drawings based on filtering the optical signal reflected by the FBG sensor or corresponding data through the bandpass and bandstop filtering algorithms of the optical signal converter algorithm. The drawings may include a drawing of the curvature of each FBG sensor of the selected FBG sensor on the display screen 150 or 250 of the shape sensing system 100 or 200 relative to time. The drawings may include a displayable shape on a three-dimensional grid corresponding to the optical fiber probe in three-dimensional space. The displayable shape is substantially free of heartbeat-related fluid dynamic noise.

[0102] The method further comprises the step of displaying on display screen 150 or 250 the periodic variation of strain in a plot of curvature versus time of any of the selected FBG sensors at the moment the tip of medical device 110 or its fiber optic probe is advanced into the patient's heart.

[0103] Each of the plurality of methods for determining whether the tip of the medical device 110 is located within the heart of the patient includes a pushing step of pushing the tip of the medical device 110 toward the heart through the vascular system of the patient. As described above, the medical device 110 (e.g., PICC 310) includes an integrated fiber optic probe (e.g., fiber optic probe 424) having a plurality of FBG sensors (e.g., FBG sensors 426a, 426b, 426c, ... 426n) at least along the distal portion of the fiber optic probe for shape sensing using a shape sensing system 100 or 200 including the medical device 110. When the medical device 110 is a PICC 310, the pushing step may include pushing the tip of the PICC 310 through the right basilar vein, the right axillary vein, the right subclavian vein, the right brachiocephalic vein, and into the SVC. When the medical device is a CVC, the pushing step includes pushing the tip of the CVC through the right internal jugular vein, the right brachiocephalic vein, and into the SVC.

[0104] The method may include enabling certain functions of the shape sensing system 100 or 200 by opening the console 140 or 240, running one or more programs on the console 140 or 240, making a selection of FBG sensors in the distal portion of the fiber optic probe (e.g., selecting FBG sensors 426a, 426b, 426c..., 426n), for plotting curvature versus time 1012a, 1012b, 1012c..., 1012n, making optical or electrical connections or other content as required for various functions of the shape sensing system 100 or 200.

[0105] Enabling certain functions of shape sensing system 100 or 200 may include a first enabling or allowing step of enabling or allowing input optical signals to be sent by optical interrogator 130 or 230 of shape sensing system 100 or 200 into the fiber optic probe while advancing the tip of medical device 110 through the patient's vasculature.

[0106] Enabling certain functions of the shape sensing system 100 or 200 may include a second enabling or enabling step of enabling or allowing conversion of a heartbeat sequence to a heartbeat frequency by a heartbeat converter algorithm of the console 140 or 240 of the shape sensing system 100 or 200. The second enabling or enabling step is during a detection step of detecting a heartbeat sequence with a heartbeat detection device of the shape sensing system 100 or 200, which is used to detect the heartbeat sequence while advancing the tip of the medical device 110 through the vasculature of the patient.

[0107] Enabling certain functions of shape sensing system 100 or 200 may include a third enabling or enabling step of enabling or permitting receipt of an optical signal reflected by a FBG sensor from a fiber optic probe by optical interrogator 130 or 230 while advancing the tip of medical device 110 through the patient's vasculature.

[0108] Enabling certain functions of the shape sensing system 100 or 200 may include a fourth enabling or allowing step of enabling or allowing optical signals reflected from the FBG sensor received from the optical fiber probe to be algorithmically converted into mappable data via a plurality of optical signal converter algorithms.

[0109] The optical signal converter algorithm may include a bandpass filtering algorithm for selecting FBG sensors (e.g., the last three FBG sensors) along the distal portion of the optical fiber probe. The bandpass filtering algorithm allows FBG sensor reflected optical signals or corresponding data that appear at one or more frequencies within the frequency range around the heartbeat frequency to pass therethrough, while rejecting FBG sensor reflected optical signals or corresponding data that appear at one or more frequencies outside the frequency range around the heartbeat frequency.

[0110] The optical signal converter algorithm may include a band-stop filtering algorithm for the FBG sensor on the proximal side of the FBG sensor selection. The band-stop filtering algorithm rejects the FBG sensor reflected optical signals or corresponding data that appear at one or more frequencies within the frequency range around the heartbeat frequency, while passing the FBG sensor reflected optical signals or corresponding data that appear at one or more frequencies outside the frequency range around the heartbeat frequency.

[0111] Enabling certain functions of the shape sensing system 100 or 200 may include a fifth enabling or allowing step that enables or allows plottable data to be plotted in a plurality of different plots on the display screen 150 or 250 of the shape sensing system 100 or 200 (e.g., a plot 1004 of curvature versus arc length, a plot 1006 of torsion versus arc length, a plot 1008 of angle versus arc length, a plot 1010 of position versus time, one or more plots 1012a, 1012b, 1012c, ..., 1012n of curvature versus time, etc.).

[0112] Enabling certain functions of the shape sensing system 100 or 200 may include a sixth enabling or allowing step that enables or allows the algorithmic conversion of the optical signal reflected by the FBG sensor received from the fiber optic probe into a displayable shape on the three-dimensional grid 1002 on the display screen 150 or 250 of the shape sensing system 100 or 200 for the medical device 110.

[0113] The method may include an identification step of manually identifying on the display screen 150 or 250 a specific change in the plotted curvature of the fiber probe sensed by the selected FBG sensor in the distal portion of the fiber probe at the moment when the tip of the medical device 110 is advanced into the heart, thereby determining that the tip of the medical device 110 is located within the heart. The identification step may include identifying a transient decrease in the plotted curvature followed by a transient increase in the plotted curvature of the fiber probe sensed by each of the last three FBG sensors (e.g., FBG sensors 426a, 426b, and 426c) in the distal portion of the fiber probe at the moment when the tip of the medical device 110 is advanced into the heart. Additionally or alternatively, the method may include a determination step of automatically determining, using a heart determiner algorithm, a specific change in the plotted curvature of the fiber probe or its plottable data (sensed by selecting the FBG sensor in the distal portion of the fiber probe) at the moment when the tip of the medical device 110 is advanced into the heart.

[0114] The method may include a stopping step of stopping advancing the tip of the medical device 110 through the patient's vasculature after determining that the tip of the medical device 110 is located in the heart.

[0115] The method may include an identification or confirmation step of identifying or confirming that the tip of the medical device 110 is in the heart by a periodic change in the plotted curvature of the optical fiber probe sensed by the selected FBG sensor. For example, the identification step may include identifying on the display screen 150 or 250 a periodic change in strain in a plot of curvature versus time of any of the selected FBG sensors at the moment the tip of the medical device 110 is advanced into the patient's heart, thereby determining that the tip of the medical device 110 is located within the heart.

[0116] In particular, neither of the methods of shape sensing systems 100 or 200 requires X-rays to determine whether the tip of medical device 110 is located within the patient's heart. As such, the patient does not have to be exposed to ionizing X-ray radiation when using shape sensing system 100 or 200. In addition, neither of the methods of shape sensing system 100 or 200 requires an additional magnetic sensor device of a host device for determining whether the tip of medical device 110 is located within the patient's heart. In addition, because shape sensing system 100 or 200 does not require the use of a reliable P wave of an ECG as some existing systems for placing the tip of a medical device into a patient's heart do, shape sensing system 100 or 200 can be used for patients with atrial fibrillation or other arrhythmias.

[0117] Although some specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. A person of ordinary skill in the art may conceive of additional adaptations and / or modifications, and in a broader aspect, these adaptations and / or modifications are also included. Therefore, without departing from the scope of the concepts provided herein, it is possible to deviate from the specific embodiments disclosed herein.

Claims

1. A shape sensing system, comprising: One or more medical devices, including: an integrated fiber optic probe having a plurality of fiber Bragg grating sensors along a distal portion of the fiber optic probe; and A heartbeat detection device, used for detecting a heartbeat sequence; The console, including memory and one or more processors, is configured to: Converting the heartbeat sequence to a heartbeat frequency via a heartbeat converter algorithm; and converting optical signals reflected from fiber Bragg grating sensors of the fiber optic probe into plottable data by a plurality of optical signal converter algorithms, the optical signal converter algorithms including a bandpass filtering algorithm for a selected one of the fiber Bragg grating sensors along a distal portion of the fiber optic probe, the bandpass filtering algorithm being configured to pass optical signals or corresponding data reflected from fiber Bragg grating sensors occurring at one or more frequencies within a frequency range around a heartbeat frequency while rejecting optical signals or corresponding data reflected from fiber Bragg grating sensors occurring at one or more frequencies outside the frequency range around a heartbeat frequency; and a display screen configured to display any of a plurality of plots of the plottable data, the plurality of plots including a plot of curvature of each of the selected ones of the fiber Bragg grating sensors versus time for identifying cyclical changes in strain of the fiber optic probe as the tip of the fiber optic probe is advanced into the heart of a patient.

2. The shape sensing system according to claim 1, wherein: The optical signal converter algorithm includes a band-stop filtering algorithm for a fiber Bragg grating sensor proximal to the selected fiber Bragg grating sensor, the band-stop filtering algorithm being configured to reject optical signals or corresponding data reflected by the fiber Bragg grating sensor that occur at one or more frequencies within a frequency range around a heartbeat frequency, while passing optical signals or corresponding data reflected by the fiber Bragg grating sensor that occur at one or more frequencies outside the frequency range around the heartbeat frequency.

3. The shape sensing system according to claim 2, wherein: The plurality of plots include displayable shapes on a three-dimensional grid corresponding to the fiber optic probes in three-dimensional space, the displayable shapes being substantially free of heartbeat-related fluid dynamic noise.

4. The shape sensing system according to any one of claims 1 to 3, wherein: The heartbeat detection device is incorporated into the same medical device as the medical device including the optical fiber probe.

5. The shape sensing system according to claim 4, wherein: The same medical device including the fiber optic probe has electrocardiogram electrodes electrically connected to an electrocardiogram component in the console via cables for detecting heartbeat sequences.

6. The shape sensing system according to claim 4, wherein: The same medical device including the fiber optic probe has one or more lumens configured to contain a saline solution, the medical device including a cable that connects the one or more lumens to an electrocardiogram component in the console to detect a heartbeat sequence when filled with the saline solution.

7. The shape sensing system according to any one of claims 1 to 3, wherein: The heartbeat detection device is incorporated into a medical device different from the medical device including the optical fiber probe.

8. The shape sensing system according to claim 7, wherein: The different medical devices include electrocardiogram skin electrodes electrically connected to an electrocardiogram component in the console for detecting heartbeat sequences.

9. According to the shape sensing system of claim 1, the console includes a heart determiner algorithm, which is configured to automatically confirm on the display screen that the tip of the fiber optic probe is in the patient's heart with the help of periodic changes in the strain of the fiber optic probe sensed by the selected fiber Bragg grating sensor, the periodic changes in strain being caused by heartbeat-related fluid dynamics.

10. The shape sensing system according to claim 1 further comprises an optical interrogator, wherein the optical interrogator is configured to send an input optical signal into the optical fiber probe and receive an optical signal reflected by the fiber Bragg grating sensor from the optical fiber probe, and the optical interrogator is a stand-alone optical interrogator or an integrated optical interrogator integrated into the console.

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