Systems and methods of shape sensing and reference framing medical devices having electromagnetoresponsive elements

Abstract

A medical-device visualization system includes an elongate medical device having passive electromagnetoresponsive ("EMR") elements distributed along a length thereof, a magnetic interrogator having magnetic transducers for transducing responses of the EMR elements to an external magnetic field, and a console for visualizing a shape of the medical device as it is advanced through a vasculature of a patient within the external magnetic field. A registration process of the console registers the EMR elements including a distalmost EMR element of the medical device at various magnetic transducers. A shape-sensing process senses the shape of the medical device from time-dependent location data for the EMR elements from the magnetic interrogator. A reference-framing process places the shape of the medical device in a patient-based reference frame following conversion of the location data from a magnetic interrogator-based coordinate system to a patient-based coordinate system in the patient-based reference frame.

Description

Docket No. 101672.0632PCTSYSTEMS AND METHODS OF SHAPE SENSING AND REFERENCE FRAMING MEDICAL DEVICES HAVING ELECTROMAGNETORESPONSIVE ELEMENTSPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 699,761, filed September 26, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Intravascular guidance of medical devices including guidewires, catheters, and the like have often used fluoroscopic methods for guiding distal tips of such medical devices through vasculatures and determining whether the distal tips are appropriately placed in their target anatomical locations. However, the fluoroscopic methods expose patients and their attending clinicians to harmful X-ray radiation. Moreover, the patients can be exposed to potentially harmful contrast media needed for the fluoroscopic methods. For these reasons, some current medical research has turned to developing optical methods such as fiber-optic shape-sensing (“FOSS”) methods for the intravascular guidance of medical devices. However, FOSS systems including the medical devices thereof can be expensive and more delicate than desired for manufacturers and customers alike. In addition, it can be difficult in such FOSS systems to establish a patient-based reference frame for placing sensed shapes of the medical devices, particularly when torsional strains in the optical fibers of the medical devices result in orientation-type shape-sensing errors distal of the torsional strains.

[0003] Disclosed herein are systems and methods of shape sensing and reference framing medical devices with electromagnetoresponsive elements that address the foregoing need.SUMMARY

[0004] Disclosed herein is a medical-device visualization system including, in some embodiments, a first medical device, an optional second medical device, a magnetic interrogator, and a console. The first medical device includes an elongate portion having a plurality of passive electromagnetoresponsive (“EMR”) elements distributed along a length thereof for sensing a shape of the elongate portion of the first medical device. The second medical device includes an elongate portion and at least one EMR element for establishing aDocket No. 101672.0632PCT reference frame for the shape of the first medical device. The magnetic interrogator includes a plurality of magnetic transducers configured to a) generate an external magnetic field to which each EMR element of the EMR elements responds and b) transduce responses of the EMR elements to the external magnetic field. Transduction of the responses of the EMR elements to the external magnetic field generates time-dependent location data for the EMR elements set in a magnetic interrogator-based coordinate system of a system-based reference frame defined by the plurality of magnetic transducers. The console includes electronic components and circuitry including memory and one or more processors. The memory includes executable instructions configured to instantiate medical-device visualization processes upon execution by the processor(s) for visualizing the shape of the elongate portion of the first medical device as it is advanced through a vasculature of a patient within the external magnetic field. The medical -device visualization processes include a registration process, a shape-sensing process, and a reference-framing process. The registration process utilizes registration logic for registering the EMR elements including a distalmost EMR element of the first medical device at various magnetic transducers of the plurality of magnetic transducers. The shape-sensing process utilizes shape-sensing logic for sensing the shape of the elongate portion of the first medical device from the location data. The reference-framing process utilizes referenceframing logic for placing the shape of the elongate portion of the first medical device in a patient-based reference frame following conversion of the location data from the magnetic interrogator-based coordinate system to a patient-based coordinate system in the patient-based reference frame.

[0005] In some embodiments, the medical-device visualization processes further include a coordinate-system conversion process that utilizes coordinate-system conversion logic to convert the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system in the patient-based reference frame.

[0006] In some embodiments, the patient-based reference frame is defined by a specific patient model established by one or more imaging techniques performed on the patient selected from ultrasound imaging, X-ray imaging, computed tomography (“CT”) scanning, and magnetic resonance imaging (“MRI”).

[0007] In some embodiments, the patient-based reference frame is defined by a nonspecific patient model fitted to the patient by measurements among various physical features of the patient.Docket No. 101672.0632PCT

[0008] In some embodiments, the first medical device is a catheter including a central venous catheter (“CVC”) or a peripherally inserted central catheter (“PICC”). In addition, the plurality of passive EMR elements is distributed along at least a distal portion of a catheter tube of the catheter.

[0009] In some embodiments, the second medical device is present, the second medical device is a catheter introducer, and the at least one EMR element is about a proximal portion of an introducer sheath of the catheter introducer for indicating an insertion site on the patient.

[0010] In some embodiments, the registration process further registers the EMR elements including the at least one EMR element of the catheter introducer at the various magnetic transducers of the plurality of magnetic transducers. Registration of the foregoing EMR elements registers a static location of the insertion site on the patient together with a dynamic location of the distalmost EMR element of the first medical device as the elongate portion thereof is advanced through the vasculature of the patient.

[0011] In some embodiments, the location of the insertion site on the patient provides a common local-extremum point between the magnetic interrogator-based coordinate system of the system-based reference frame and the patient-based coordinate system of the patientbased reference frame for converting the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system.

[0012] In some embodiments, locations of the plurality of transducers provide common local-minimum points between the magnetic interrogator-based coordinate system of the system-based reference frame and the patient-based coordinate system of the patient-based reference frame when the patient lies on or above the magnetic interrogator for converting the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system.

[0013] In some embodiments, the medical-device visualization system further includes a display screen. The medical-device visualization processes further include a medical-device displaying process that utilizes medical-device displaying logic to display a graphical representation of the elongate portion of the first medical device within a patient avatar on the display screen.Docket No. 101672.0632PCT

[0014] In some embodiments, the medical-device displaying process further displays an insertion-site icon over the patient avatar.

[0015] Also disclosed herein is a method of a medical-device visualization system including, in some embodiments, executing executable instructions stored in memory of a console by one or more processors of the console. Execution of the foregoing instructions instantiates medical-device visualization processes for visualizing a shape of an elongate portion of a first medical device as it is advanced through a vasculature of a patient within an external magnetic field. The first medical device includes a plurality of passive EMR elements distributed along a length of the elongate portion of the first medical device for sensing a shape thereof. The method also includes generating the external magnetic field with a magnetic interrogator including a plurality of magnetic transducers. Each EMR element of the EMR elements is responsive to the external magnetic field. The EMR elements include that of an optional second medical device including an elongate portion and at least one EMR element. The method also includes transducing responses of the EMR elements to the external magnetic field, thereby generating time-dependent location data for the EMR elements set in a magnetic interrogator-based coordinate system of a system-based reference frame defined by the plurality of magnetic transducers. The method also includes registering with a registration process of the medical -device visualization processes the EMR elements including a distalmost EMR element of the first medical device at various magnetic transducers of the plurality of magnetic transducers. The method also includes shape-sensing with a shape-sensing process of the medical-device visualization processes the shape of the elongate portion of the first medical device from the location data. The method also includes placing with a reference-framing process of the medical-device visualization processes the shape of the elongate portion of the first medical device in a patient-based reference frame following conversion of the location data from the magnetic interrogator-based coordinate system to a patient-based coordinate system in the patient-based reference frame.

[0016] In some embodiments, the method further includes converting with a coordinate-system conversion process of the medical-device visualization processes the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system in the patient-based reference frame.

[0017] In some embodiments, the patient-based reference frame is defined by a specific patient model established by one or more imaging techniques performed on the patient selectedDocket No. 101672.0632PCT from ultrasound imaging, X-ray imaging, computed tomography (“CT”) scanning, and magnetic resonance imaging (“MRI”).

[0018] In some embodiments, the patient-based reference frame is defined by a nonspecific patient model fitted to the patient by measurements among various physical features of the patient.

[0019] In some embodiments, the first medical device is a catheter including a central venous catheter (“CVC”) or a peripherally inserted central catheter (“PICC”). In addition, the plurality of passive EMR elements is distributed along at least a distal portion of a catheter tube of the catheter.

[0020] In some embodiments, the second medical device is present, the second medical device is a catheter introducer, and the at least one EMR element is about a proximal portion of an introducer sheath of the catheter introducer for indicating an insertion site on the patient.

[0021] In some embodiments, the registration process further registers the EMR elements including the at least one EMR element of the catheter introducer at the various magnetic transducers of the plurality of magnetic transducers. Registration of the foregoing EMR elements registers a static location of the insertion site on the patient together with a dynamic location of the distalmost EMR element of the first medical device as the elongate portion thereof is advanced through the vasculature of the patient.

[0022] In some embodiments, the location of the insertion site on the patient provides a common local-extremum point between the magnetic interrogator-based coordinate system of the system-based reference frame and the patient-based coordinate system of the patientbased reference frame for converting the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system.

[0023] In some embodiments, locations of the plurality of transducers provide common local-minimum points between the magnetic interrogator-based coordinate system of the system-based reference frame and the patient-based coordinate system of the patient-based reference frame when the patient lies on or above the magnetic interrogator for converting the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system.Docket No. 101672.0632PCT

[0024] In some embodiments, the method further includes displaying with a medicaldevice displaying process of the medical-device visualization processes a graphical representation of the elongate portion of the first medical device within a patient avatar on a display screen.

[0025] In some embodiments, the medical-device displaying process further displays an insertion-site icon over the patient avatar.

[0026] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0027] FIG. 1 is a block diagram of a first medical-device visualization system in accordance with some embodiments.

[0028] FIG. 2 is a block diagram of a second medical-device visualization system in accordance with some embodiments.

[0029] FIG. 3 illustrates the first medical-device visualization system with a catheter and catheter introducer including EMR elements in accordance with some embodiments.

[0030] FIG. 4A illustrates the catheter including the EMR elements in accordance with some embodiments.

[0031] FIG. 4B illustrates the catheter introducer including the EMR elements in accordance with some embodiments.

[0032] FIG. 4C illustrates a stylet including the EMR elements in accordance with some embodiments.

[0033] FIG. 5A illustrates a detailed view of a distal portion of the catheter or stylet in accordance with some embodiments.

[0034] FIG. 5B illustrates a detailed view of a proximal portion of the catheter introducer in accordance with some embodiments.Docket No. 101672.0632PCT

[0035] FIG. 6A illustrates the medical-device visualization system with the catheter and catheter introducer in use on a patient during a medical procedure in accordance with some embodiments.

[0036] FIG. 6B illustrates the medical-device visualization system with the catheter in use on the patient during the medical procedure but subsequent to removal of the catheter introducer in accordance with some embodiments.

[0037] FIG. 7 illustrates conversion of location data for the EMR elements from a magnetic interrogator-based coordinate system to a patient-based coordinate system as well as display of a graphical representation of the catheter including the EMR elements on a display screen in accordance with some embodiments.

[0038] FIG. 8 illustrates triangulation of the EMR elements with various magnetic transducers of a magnetic interrogator of the medical-device visualization system in accordance with some embodiments.DESCRIPTION

[0039] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0040] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. In addition, any of the foregoing features or steps can, in turn, further include one or more features or steps unless indicated otherwise. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particularDocket No. 101672.0632PCT fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0041] “Proximal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near or relatively nearer to a clinician when the medical device is used on a patient. For example, a “proximal portion” or “proximal section” of the medical device includes a portion or section of the medical device intended to be near the clinician when the medical device is used on the patient. Likewise, a “proximal length” of the medical device includes a length of the medical device intended to be near the clinician when the medical device is used on the patient. A “proximal end” of the medical device is an end of the medical device intended to be near the clinician when the medical device is used on the patient. The proximal portion, the proximal section, or the proximal length of the medical device need not include the proximal end of the medical device. Indeed, the proximal portion, the proximal section, or the proximal length of the medical device can be short of the proximal end of the medical device. However, the proximal portion, the proximal section, or the proximal length of the medical device can include the proximal end of the medical device. Should context not suggest the proximal portion, the proximal section, or the proximal length of the medical device includes the proximal end of the medical device, or if it is deemed expedient in the following description, “proximal portion,” “proximal section,” or “proximal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “proximal end portion,” a “proximal end section,” or a “proximal end length” of the medical device, respectively.

[0042] “Distal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near, relatively nearer, or even in a patient when the medical device is used on the patient. For example, a “distal portion” or “distal section” of the medical device includes a portion or section of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. Likewise, a “distal length” of the medical device includes a length of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. A “distal end” of the medical device is an end of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. The distal portion, the distal section, or the distal length of the medical device need not include the distal end of the medicalDocket No. 101672.0632PCT device. Indeed, the distal portion, the distal section, or the distal length of the medical device can be short of the distal end of the medical device. However, the distal portion, the distal section, or the distal length of the medical device can include the distal end of the medical device. Should context not suggest the distal portion, the distal section, or the distal length of the medical device includes the distal end of the medical device, or if it is deemed expedient in the following description, “distal portion,” “distal section,” or “distal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “distal end portion,” a “distal end section,” or a “distal end length” of the medical device, respectively.

[0043] “Location” is used to indicate a location of a medical device or portion thereof including the EMR elements in some spatial or coordinate system such as the magnetic interrogator-based coordinate system or the patient-based coordinate system set forth below.

[0044] “Shape” is used to indicate a plain shape of a medical device or portion thereof including the EMR elements in the location of the medical device. By way of example, the shape of the medical device graphically represented within the magnetic interrogator-based coordinate system or the patient-based coordinate system of FIG. 7 is a ‘J’ shape.

[0045] Orientation” is used to indicate an orientation of a medical device or portion thereof including the EMR elements in the location of the medical device. By way of example, a distal tip of the medical device graphically represented within the magnetic interrogatorbased system of FIG. 7 is oriented toward the z-plane in a standard right-handed coordinate system. Upon conversion of the foregoing coordinate system to the patient-based coordinate system, the distal tip of the medical device is in the superior vena cava (“SVC”) with an orientation toward the right atrium of the heart.

[0046] When used, “position” combines one or more aspects of the shape or orientation of a medical device or portion thereof including the EMR elements in the location of the medical device. By way of example, at least a distal portion of the medical device can be in malposition when the distal portion of the medical device is folded over itself such that a distal tip of the medical device is oriented away from the heart.

[0047] “Reference frame” is used to indicate a relational structure that relates objects or events to a particular system, thereby providing context to existence of the objects or occurrence of the events. In an example, the system-based reference frame set forth belowDocket No. 101672.0632PCT relates the EMR elements or their responses to the external magnetic field to the medical-device visualization system. In another example, the patient-based reference frame set forth below relates the EMR elements or their responses to the external magnetic field to a patient. Notably, a reference frame can include a coordinate system defined by one or more elements of the particular system to which the reference frame corresponds, thereby defining relationships of the objects or events to the foregoing system.

[0048] “Logic” can be hardware, firmware, or software configured to perform one or more functions. As hardware, logic can include circuitry having data processing functionality, data storage functionality, or both. An example of such circuitry can include, but is not limited to, a hardware processor (e.g., a microprocessor, one or more processor cores, a digital-signal processor [“DSP”], a programmable gate array [“PGA”], a microcontroller, an applicationspecific integrated circuit [“ASIC”], etc.) or semiconductor memory. As firmware, the logic can be stored in persistent storage. As software, logic can include one or more processes, instances, Application Programming Interfaces (“APIs”), subroutines, functions, applets, servlets, or routines. Logic can also include source code, object code, a shared library, a dynamic link library (“DLL”), or even one or more instructions. Such software can be stored in any type of suitable non -transitory storage medium or transitory storage medium (e.g., electrical, optical, acoustical, or any other form of propagated signal including carrier waves, infrared signals, or digital signals). An example of a non-transitory storage medium can include, but is not limited to, a programmable circuit; non-persistent storage such as volatile memory (e.g., any type of random-access memory [“RAM”]); or persistent storage such as non-volatile memory (e.g., read-only memory [“ROM”], power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, a hard-disk drive, an optical-disc drive, or a portable memory device.

[0049] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0050] Again, intravascular guidance of medical devices including guidewires, catheters, and the like have often used fluoroscopic methods for guiding distal tips of such medical devices through vasculatures and determining whether the distal tips are appropriately placed in their target anatomical locations. However, the fluoroscopic methods expose patients and their attending clinicians to harmful X-ray radiation. Moreover, the patients can be exposed to potentially harmful contrast media needed for the fluoroscopic methods. For these reasons,Docket No. 101672.0632PCT some current medical research has turned to developing optical methods such as fiber-optic shape-sensing (“FOSS”) methods for the intravascular guidance of medical devices. However, FOSS systems including the medical devices thereof can be expensive and more delicate than desired for manufacturers and customers alike. In addition, it can be difficult in such FOSS systems to establish a patient-based reference frame for placing sensed shapes of the medical devices, particularly when torsional strains in the optical fibers of the medical devices result in orientation-type shape-sensing errors distal of the torsional strains.

[0051] Disclosed herein are systems and methods of shape sensing and reference framing medical devices with EMR elements that address the foregoing need.Medical-device visualization systems

[0052] FIG. 1 is a block diagram of a first medical-device visualization system 100 in accordance with some embodiments. FIG. 2 is a block diagram of a second medical-device visualization system 200 in accordance with some embodiments. FIG. 3 illustrates the medicaldevice visualization system 100 with the catheter 132 and the catheter introducer 146 as medical devices of the medical-device visualization system 100 including the EMR elements 102 in accordance with some embodiments. FIGS. 6A and 6B illustrate the medical-device visualization system 100 with the catheter 132 and the catheter introducer 146 in use on a patient during a medical procedure in accordance with some embodiments.

[0053] As shown, the medical-device visualization system 100 includes a plurality of EMR elements 102 distributed among one or more medical devices including at least the first medical device set forth below, a stand-alone magnetic interrogator 104, a console 106, and an integrated display screen 108, wherein the integrated display screen 108 is integrated into the console 106. The medical -device visualization system 200 includes the EMR elements 102 distributed among the medical device(s) including at least the first medical device set forth below, the magnetic interrogator 104, the console 106, albeit without the integrated display screen 108, and a separate display screen 208 such as that of a stand-alone monitor. However, medical -device visualization systems are not limited to the medical-device visualization system 100 or 200. Indeed, such medical-device visualization systems 100 and 200 are examples that convey certain concepts of shape-sensing and visualizing medical devices with the EMR elements 102. With this in mind, description set forth below is primarily provided with respect to the medical-device visualization system 100 for expository expediency, but such description can be extended to the medical-device visualization system 200 and similar systems.Docket No. 101672.0632PCTConsoles

[0054] The console 106 has electronic components and circuitry including memory 110 and one or more processors 112. The memory 110 includes executable instructions 114 configured to instantiate medical-device visualization processes upon execution by the processor(s) 112 for shape-sensing and visualizing medical devices including the EMR elements 102 as each medical device or elongate portion thereof is advanced through a vasculature of a patient within an external magnetic field. Such medical-device visualization processes are set forth below in more detail together with various types of logic 116 of the console 106 utilized for the medical-device visualization processes.

[0055] The console 106 also includes a magnetic-interrogator connector 118. The magnetic-interrogator connector 118 can be configured as a standard power-and-data connector complementary to that of the magnetic interrogator 104 set forth below for operably connecting the magnetic interrogator 104 to the console 106 or disconnecting the magnetic interrogator 104 from the console 106. Advantageously, the console 106 can be configured to automatically instantiate the medical-device visualization processes for shape-sensing and visualizing medical devices including the EMR elements 102 when the magnetic interrogator 104 is connected to the console 106.Magnetic interrogator

[0056] FIGS. 3, 6A, and 6B also illustrate the magnetic interrogator 104 of the medicaldevice visualization system 100 with in accordance with some embodiments.

[0057] The magnetic interrogator 104 includes a plurality of magnetic transducers 120 having a known relationship to each other. Thus, the magnetic interrogator 104 is configured to generate an external magnetic field through which medical devices including the EMR elements 102 move (or not) and to which the EMR elements 102 respond. In addition, the magnetic interrogator 104 is configured to transduce resonance-based responses of the EMR elements 102 to the external magnetic field. Transduction of the responses of the EMR elements 102 to the external magnetic field generates time-dependent location data for the EMR elements 102 set in a magnetic interrogator-based coordinate system 122 of a systembased reference frame 124 defined by the plurality of magnetic transducers 120, which location data is provided to the console 106.Docket No. 101672.0632PCT

[0058] The magnetic interrogator 104 can include a console connector 126. The console connector 126 can be configured as a standard power-and-data connector complementary to that of the console 106 set forth above for operably connecting the magnetic interrogator 104 to the console 106 or disconnecting the magnetic interrogator 104 from the console 106.

[0059] It should be understood that location data of the EMR elements 102 are defined in the magnetic interrogator-based coordinate system 122, which, in turn, is defined by the magnetic transducers 120 of the magnetic interrogator 104 and their known relationship to each other. Such a coordinate system 122 can be converted by the console 106 to a patient-based coordinate system 128 in a patient-based reference frame 130 defined in a specific or nonspecific patient model. Indeed, the specific patient model can be established by one or more imaging techniques including, but not limited to, ultrasound imaging, X-ray imaging, computed tomography (“CT”) scanning, or magnetic resonance imaging (“MRI”). Alternatively, measurements among various physical features of a patient can be used to proportionally fit a non-specific patient model to the patient.EMR elements

[0060] FIGS. 3, 4A-4C, 5A, and 5B illustrate the EMR elements 102 in context with various medical devices in accordance with some embodiments. Indeed, FIGS. 3 and 4A-4C illustrate the various medical devices with their EMR element(s) 102 in accordance with some embodiments, while FIG. 5A illustrates a detailed view of a distal portion of the first medical device in accordance with some embodiments and FIG. 5B illustrates a detailed view of a proximal portion of the second medical device accordance with some embodiments.

[0061] As shown, the EMR element(s) 102 can be in any portion of a medical device disclosed herein. As to the first medical device, which can be the catheter 132 or the stylet 134, as set forth below, the EMR elements 102 are typically in an elongate portion thereof for shapesensing and visualizing the first medical device by way of the medical-device visualization system 100. More specifically, the EMR elements 102 are typically in the distal portion of the elongate portion of the first medical device. Indeed, such EMR elements 102 are shown by way of EMR elements 102a, 102b, 102c, ..., 102 / ? along at least the distal portion of the first medical device of FIG. 5 A for shape-sensing and visualizing the first medical device by way of the medical -device visualization system 100. As to the second medical device, which can be the catheter introducer 146, as set forth below, the EMR element(s) 102 is(are) typically in anDocket No. 101672.0632PCT elongate portion thereof for assisting with the shape-sensing and visualizing of the first medical device by facilitating establishment of one or more reference frames for the shape-sensing. More specifically, the EMR element(s) 102 is(are) typically in the proximal portion of the elongate portion of the second medical device. That said, the EMR element(s) 102 can be incorporated into another body of the second medical device such as within a hub thereof (e.g., the sheath hub 152 of the catheter introducer 146).

[0062] The EMR elements 102 are passive EMR elements 102 in that each EMR element of the EMR elements 102 is not internally powered by an internal power source via its corresponding medical device or externally powered by an external power source operably coupled to the medical device. Instead, the EMR elements 102 are responsive to the external magnetic field of the magnetic interrogator 104, itself. While embracing some theoretical flexibility, each EMR element of the EMR elements 102 can have a natural frequency of vibration that, when matched by the external magnetic field, urges the EMR element 102 to resonate with the external magnetic field in response. Such resonance, in turn, creates local magnetic fields about the EMR elements 102 that are detected and transduced by the magnetic transducers 120 of the magnetic interrogator 104.

[0063] The EMR elements 102 can have sufficient physical and chemical integrity for sterilization by dry heat, moist heat, optionally, in combination with pressure (e.g., by an autoclave), a biocide (e.g., hydrogen peroxide, ethylene oxide, etc.), optionally, in combination with pressure, radiation (e.g., ultraviolet radiation), or a combination thereof when the medical device including the EMR elements 102 is sterilized.Medical devices

[0064] FIGS. 3, 4A-4C, 5A, and 5B illustrate various medical devices or portions thereof in accordance with some embodiments. Indeed, each of FIGS. 4A, 4C, and 5 A illustrate a first medical device or an elongate portion thereof configured for shape-sensing and visualizing the first medical device by way of the medical-device visualization system 100 in accordance with some embodiments. FIGS. 4B and 5B illustrate a second medical device or an elongate portion thereof configured for assisting in the shape-sensing and visualizing of the first medical device by way of the medical-device visualization system 100 in accordance with some embodiments. In accordance with the foregoing, the first medical device typically includes the plurality of EMR elements 102 such as EMR elements 102a, 102b, 102c, . . ., 102w distributed along a length of the distal portion of the first medical device for shape-sensing andDocket No. 101672.0632PCT visualizing the first medical device by way of the medical-device visualization system 100. Further in accordance with the foregoing, the second medical device typically includes at least one EMR element 102 in the proximal portion of the second medical device for assisting with the shape-sensing and visualizing of the first medical device by facilitating the establishment of one or more reference frames for the shape-sensing. It should be understood that the first medical device has many EMR elements 102 and the second medical device has up to a few EMR elements 102, at most, for respectively sensing a shape of the distal portion of the first medical device and assisting in such sensing by providing at least one instant or memory-stored static location of the proximal portion of the second medical device for the reference frames 124 and 130.

[0065] FIG. 5 A illustrates a catheter 132 including the EMR elements 102 in accordance with some embodiments, and FIG. 5B illustrates a stylet 134 including the EMR elements 102 in accordance with some embodiments.

[0066] As shown, the first medical device can be the catheter 132, for example, a CVC or PICC, as shown in FIG. 5 A. Alternatively, the first medical device can be the stylet 134 or some other probe as shown in FIG. 5B. Notably, if an existing catheter without the EMR elements 102 is to be navigated through a vasculature of a patient and placed therein by way of the medical-device visualization system 100, the first medical device is the stylet 134 disposed in the catheter. However, it should be understood that both the catheter 132 and the stylet 134 can be redundantly used together to navigate the catheter 132 through a vasculature of a patient for placement therein by way of the medical-device visualization system 100. In such embodiments, the catheter 132 and the stylet 134 are different instances of the first medical device.

[0067] With the catheter 132 as an example of the first medical device, the catheter 132 can include a catheter tube 136, a catheter hub 138, one or more extension legs 140, and one or more Luer connectors 142 operably and respectively connected in the foregoing order. When such a catheter 132 is multiluminal (e.g., diluminal, triluminal, etc.), the catheter tube 136 includes multiple catheter-tube lumens (e.g., two catheter-tube lumens, three catheter-tube lumens, etc.), the catheter hub 138 is furcated (e.g., bifurcated, trifurcated, etc.) with multiple catheter-hub lumens (e.g., two catheter-hub lumens, three catheter-hub lumens, etc.) correspondingly fluidly connected to the multiple catheter-tube lumens (e.g., the two cathetertube lumens, the three catheter-tube lumens, etc.), and each extension leg of the two extensionDocket No. 101672.0632PCT legs 140 has an extension-leg lumen fluidly connected to a hub lumen of the multiple catheterhub lumens (e.g., the two catheter-hub lumens, the three catheter-hub lumens, etc.), thereby providing the multiluminal catheter 132. The EMR elements 102 can be incorporated within at least a distal end portion of the catheter tube 136 of the catheter 132, or the EMR elements 102 can be incorporated over such a distal end portion of the catheter tube 136, optionally, with a coating over the catheter tube 136 to secure the EMR elements 102 over the catheter tube 136 as well as provide a smooth surface of the catheter tube 136.

[0068] With the stylet 134 as an example of the first medical device, the stylet 134 can be configured to be disposed in a lumen of a catheter such as the catheter 132, the lumen being a primary lumen (also known as a distal lumen) of the foregoing catheter such that their distal ends or distal tips are approximately coterminal. The EMR elements 102 can be incorporated within at least a distal end portion of a stylet body 144 of the stylet 134, or the EMR elements 102 can be incorporated over such a distal end portion of the stylet body 144, optionally, with a coating over the stylet body 144 to secure the EMR elements 102 over the stylet body 144 as well as provide a smooth surface of the stylet body 144.

[0069] FIG. 5C illustrates a catheter introducer 146 including the EMR element(s) 102 in accordance with some embodiments.

[0070] With the catheter introducer 146 as an example of the second medical device, the catheter introducer 146 can be configured with a single lumen to accommodate the catheter tube 136 of the catheter 132 when inserted therethrough. The EMR element(s) 102 can be incorporated within at least a proximal end portion of an introducer sheath 148 of the catheter introducer 146, or the EMR element(s) 102 can be incorporated over such a proximal end portion of the introducer sheath 148, optionally, with a coating over the introducer sheath 148 to secure the EMR element(s) 102 over the introducer sheath 148 as well as provide a smooth surface of the introducer sheath 148. Regardless, at least one EMR element 102 should be in the proximal end portion of the introducer sheath 148 for alignment with or within an insertion site 150 of a patient, thereby providing at least one instant or memory-stored static location of the proximal end portion of the catheter introducer 146 for reference frame(s). Notably, the catheter introducer 146 can be splittable, the catheter introducer 146 thereby including a splittable sheath hub 152 over a proximal end portion of a splittable introducer sheath 148. Any EMR element(s) 102 incorporated within the introducer sheath 148 of the catheter introducer 146 or over the introducer sheath 148 are therefore also configured to split to allow the catheterDocket No. 101672.0632PCT introducer 146 to be removed from, for example, the catheter 132 upon insertion of the catheter 132 into a vasculature of a patient.Medical-device visualization processes

[0071] FIGS. 6A and 6B illustrate the medical-device visualization system 100 in use on a patient, thereby implementing the medical-device visualization processes during a medical procedure in accordance with some embodiments.

[0072] As set forth above, the memory 110 includes executable instructions 114 configured to instantiate medical-device visualization processes upon execution by the processor(s) 112 for shape-sensing and visualizing medical devices including the EMR elements 102. Such medical-device visualization processes are selected from at least a registration process, a shape-sensing process, a reference-framing process, and a medicaldevice displaying process. Notably, the medical-device visualization processes follow-on a transduction process of the magnetic interrogator 104 in which responses of the EMR elements 102 to the external magnetic field are transduced, thereby generating time-dependent location data for the EMR elements 102 set in the magnetic interrogator-based coordinate system 122 of the system-based reference frame 124 defined by the plurality of magnetic transducers 120.

[0073] The registration process utilizes registration logic for registering the EMR elements 102 of the first medical device and the second medical device, which can respectively be the catheter 132 and the catheter introducer 146 as shown in FIGS. 6A and 6B, at various magnetic transducers 120 of the plurality of magnetic transducers 120. Notably, registering the EMR elements 102 of the first medical device includes registering a distalmost EMR element 102 of the first medical device at various magnetic transducers 120 of the plurality of magnetic transducers 120, which can be important in tracking a distal tip of first medical device. Further, registering the EMR elements 102 of the second medical device includes registering the at least one EMR element 102 at various magnetic transducers 120 of the plurality of magnetic transducers 120. Registration of the foregoing EMR elements 102 registers dynamic locations of the EMR elements 102 of the first medical device including that of the distalmost EMR element 102 as the elongate portion of the first medical device is advanced through a vasculature of a patient together with a static location of the at least one EMR element 102 of the second medical device at an insertion site 150 on the patient providing access to the vasculature.Docket No. 101672.0632PCT

[0074] FIG. 8 illustrates triangulation of the EMR elements 102 with various magnetic transducers 120 of a magnetic interrogator 104 of the medical-device visualization system 100 in accordance with some embodiments.

[0075] As shown, the registration process or a follow-on triangulation process utilizes triangulation logic for triangulating the EMR elements 102 at various magnetic transducers 120 of the plurality of magnetic transducers 120. Notably, triangulating both the distalmost EMR element 102 of the first medical device and the at least one EMR element 102 of the second medical device with various magnetic transducers 120 of the plurality of magnetic transducers 120 while the elongate portion of the first medical device is advanced through the vasculature of the patient facilitates correction of orientation-type shape-sensing errors that might otherwise occur. Not only can the relative location vector between the distalmost EMR element 102 of the first medical device and the at least one EMR element 102 of the second medical device be tracked over time for orientation-type shape-sensing errors easily discerned by abrupt changes in shape of the elongate portion of the first medical device, but the relative location vector between the distalmost EMR element 102 of the first medical device and the at least one EMR element 102 of the second medical device indicates orientation-type shape-sensing errors when outside the magnetic interrogator-based coordinate system 122 of the system -based reference frame 124.

[0076] The shape-sensing process utilizes shape-sensing logic for sensing the shape of the elongate portion of the first medical device from the location data. Notably, the location data can include interpolated location data from an interpolation process that utilizes interpolation logic for interpolating measured location data. Interpolation of the measured location data generates the interpolated location data for one or more portions of the first medical device between any two EMR elements 102, not just adjacent EMR elements 102. Such interpolation can be beneficial in that the more EMR elements 102, the more transduction and collection of measured location data, which can affect frame rate if the console 106 is not able to instantaneously process a large amount of measured location data. Interpolation of some of the measured location data, such as that from every other EMR element 102, can effectively mitigate frame rate issues in that interpolation is less intensive for the processor(s) 112. That said, if the console 106 is able to instantaneously process a large amount of measured location data, the console 106 can generate the interpolated location data between any two adjacentDocket No. 101672.0632PCTEMR elements 102 to provide finer location data for subsequent display in the graphical representation 154 of the elongate portion of the first medical device set forth below.

[0077] FIG. 7 illustrates conversion of the location data for the EMR elements 102 from the magnetic interrogator-based coordinate system 122 to the patient-based coordinate system 128 in accordance with some embodiments.

[0078] The reference-framing process utilizes reference-framing logic for placing the shape of the elongate portion of the first medical device in the patient-based reference frame 130, which follows conversion of the location data in the magnetic interrogator-based coordinate system 122 of the system -based reference frame 124 to that of the patient-based coordinate system 128 in the patient-based reference frame 130. Indeed, the reference-framing process includes or follows-on a coordinate-system conversion process that utilizes coordinatesystem conversion logic to convert the location data from the magnetic interrogator-based coordinate system 122 to the patient-based coordinate system 128 in the patient-based reference frame 130, which, as set forth above, can be defined in a specific or non-specific patient model. Indeed, the specific patient model can be established by one or more imaging techniques including, but not limited to, ultrasound imaging, X-ray imaging, CT scanning, or MRI. Alternatively, measurements among various physical features of a patient can be used to proportionally fit a non-specific patient model to the patient.

[0079] Notably, the location of an insertion site 150 on a patient provides a common local-extremum point (i.e., a local-maximum point or local-minimum point) between the magnetic interrogator-based coordinate system 122 of the system -based reference frame 124 and the patient-based coordinate system 128 of the patient-based reference frame 130 for converting the location data from the magnetic interrogator-based coordinate system 122 to the patient-based coordinate system 128 in the foregoing coordinate-system conversion process. Further, locations of the plurality of magnetic transducers 120 provide common local-minimum points between the magnetic interrogator-based coordinate system 122 of the system -based reference frame 124 and the patient-based coordinate system 128 of the patient-based reference frame 130 when the patient lies on or above the magnetic interrogator 104 for converting the location data from the magnetic interrogator-based coordinate system 122 to the patient-based coordinate system 128 in the foregoing coordinate-system conversion process.Docket No. 101672.0632PCT

[0080] FIG. 7 also illustrates displaying a graphical representation 154 of the first medical device including the EMR elements 102 on the display screen 108 in accordance with some embodiments.

[0081] The medical-device displaying process utilizes medical-device displaying logic to display the graphical representation 154 of the elongate portion of the first medical device within a patient avatar 156 on the display screen 108 in accordance with the dynamic locations of the EMR elements 102 including that of the distalmost EMR element 102 registered to the first medical device. In addition, the medical-device displaying process can display an insertion-site icon 158 over the patient avatar 156 in accordance with the static location of the insertion site 150 on the patient registered to the at least one EMR element 102 of the second medical device. In this way, not only can the shape of the first medical device be visualized but its distal tip can be tracked on the display screen 108 from the insertion site 150, through a vasculature of a patient, and to his or her SVC. Indeed, it should be understood that the graphical representation 154 of the elongate portion of the first medical device within the patient avatar 156 can be two-dimensional like that shown in FIGS. 6A, 6B, and 7 on the display screen 108 of the console 106 or three-dimensional like that shown in FIG. 7 with respect to the patient-based coordinate system 128 of the patient-based reference frame 130.Methods

[0082] Methods of the medical-device visualization system 100 or any medical devices disclosed herein include at least methods of the medical-device visualization system 100, itself, or methods of using the medical-device visualization system 100 or medical devices.

[0083] In an example of a method of the medical-device visualization system 100, itself, the method includes executing the executable instructions 114 stored in the memory 110 of the console 106 by the processor(s) 112 of the console 106. Execution of the foregoing instructions 114 instantiates the medical-device visualization processes for visualizing the shape of the elongate portion of the first medical device as it is advanced through a vasculature of a patient within an external magnetic field. As set forth above, the first medical device includes the plurality of passive EMR elements 102 distributed along a length of the elongate portion of the first medical device for sensing the shape thereof. The method also includes generating the external magnetic field with the magnetic interrogator 104 including the plurality of magnetic transducers 120. Again, each EMR element of the EMR elements 102 is responsive to the external magnetic field. Notably, the EMR elements 102 include that of theDocket No. 101672.0632PCT second medical device, when present, which second medical device includes the elongate portion having at least one EMR element 102. The method also includes transducing responses of the EMR elements 102 to the external magnetic field, thereby generating the time-dependent location data for the EMR elements 102 set in the magnetic interrogator-based coordinate system 122 of the system -based reference frame 124 defined by the plurality of magnetic transducers 120. The method also includes registering with the registration process of the medical -device visualization processes the EMR elements 102 including the distalmost EMR element 102 of the first medical device at various magnetic transducers 120 of the plurality of magnetic transducers 120. The method also includes shape-sensing with the shape-sensing process of the medical-device visualization processes the shape of the elongate portion of the first medical device from the location data. The method also includes placing with the reference-framing process of the medical-device visualization processes the shape of the elongate portion of the first medical device in the patient-based reference frame 130 following conversion of the location data from the magnetic interrogator-based coordinate system 122 to the patient-based coordinate system 128 in the patient-based reference frame 130. Other steps or operations of the medical-device visualization system 100 can be discerned from functions and processes of the medical-device visualization system 100 disclosed herein.

[0084] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

Docket No. 101672.0632PCTCLAIMSWhat is claimed is:

1. A medical-device visualization system, comprising: a first medical device including an elongate portion having a plurality of passive electromagnetoresponsive (“EMR”) elements distributed along a length thereof for sensing a shape of the elongate portion of the first medical device; an optional second medical device including an elongate portion and at least one EMR element for establishing a reference frame for the shape of the first medical device; a magnetic interrogator including a plurality of magnetic transducers configured to: generate an external magnetic field to which each EMR element of the EMR elements responds; and transduce responses of the EMR elements to the external magnetic field, thereby generating time-dependent location data for the EMR elements set in a magnetic interrogator-based coordinate system of a systembased reference frame defined by the plurality of magnetic transducers; and a console with electronic components and circuitry including memory and one or more processors, the memory including executable instructions configured to instantiate medical-device visualization processes upon execution by the processor(s) for visualizing the shape of the elongate portion of the first medical device as it is advanced through a vasculature of a patient within the external magnetic field, and the medical-device visualization processes including: a registration process that utilizes registration logic for registering the EMR elements including a distalmost EMR element of the first medical device at various magnetic transducers of the plurality of magnetic transducers; a shape-sensing process that utilizes shape-sensing logic for sensing the shape of the elongate portion of the first medical device from the location data; andDocket No. 101672.0632PCT a reference-framing process that utilizes reference-framing logic for placing the shape of the elongate portion of the first medical device in a patientbased reference frame following conversion of the location data from the magnetic interrogator-based coordinate system to a patient-based coordinate system in the patient-based reference frame.

2. The medical-device visualization system of claim 1, the medical-device visualization processes further including a coordinate-system conversion process that utilizes coordinate-system conversion logic to convert the location data from the magnetic interrogatorbased coordinate system to the patient-based coordinate system in the patient-based reference frame.

3. The medical-device visualization system of either claim 1 or 2, wherein the patient-based reference frame is defined by a specific patient model established by one or more imaging techniques performed on the patient selected from ultrasound imaging, X-ray imaging, computed tomography (“CT”) scanning, and magnetic resonance imaging (“MRI”).

4. The medical-device visualization system of either claim 1 or 2, wherein the patient-based reference frame is defined by a non-specific patient model fitted to the patient by measurements among various physical features of the patient.

5. The medical-device visualization system of any claim of claims 1-4, wherein the first medical device is a catheter including a central venous catheter (“CVC”) or a peripherally inserted central catheter (“PICC”), and the plurality of passive EMR elements is distributed along at least a distal portion of a catheter tube of the catheter.

6. The medical-device visualization system of any claim of claims 1-5, wherein the second medical device is present, the second medical device is a catheter introducer, and the at least one EMR element is about a proximal portion of an introducer sheath of the catheter introducer for indicating an insertion site on the patient.

7. The medical-device visualization system of claim 6, wherein the registration process further registers the EMR elements including the at least one EMR element of the catheter introducer at the various magnetic transducers of the plurality of magnetic transducers, thereby registering a static location of the insertion site on the patient together with a dynamicDocket No. 101672.0632PCT location of the distalmost EMR element of the first medical device as the elongate portion thereof is advanced through the vasculature of the patient.

8. The medical-device visualization system of claim 7, wherein the location of the insertion site on the patient provides a common local-extremum point between the magnetic interrogator-based coordinate system of the system-based reference frame and the patientbased coordinate system of the patient-based reference frame for converting the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system.

9. The medical-device visualization system of either claim 7 or 8, wherein locations of the plurality of transducers provide common local-minimum points between the magnetic interrogator-based coordinate system of the system-based reference frame and the patient-based coordinate system of the patient-based reference frame when the patient lies on or above the magnetic interrogator for converting the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system.

10. The medical-device visualization system of any claim of claims 1-9, further comprising a display screen, the medical-device visualization processes further including a medical-device displaying process that utilizes medical-device displaying logic to display a graphical representation of the elongate portion of the first medical device within a patient avatar on the display screen.

11. The medical-device visualization system of claim 10, wherein the medicaldevice displaying process further displays an insertion-site icon over the patient avatar.

12. A method of a medical-device visualization system, comprising: executing executable instructions stored in memory of a console by one or more processors of the console, thereby instantiating medical-device visualization processes for visualizing a shape of an elongate portion of a first medical device as it is advanced through a vasculature of a patient within an external magnetic field, the first medical device including a plurality of passive electromagnetoresponsive (“EMR”) elements distributed along a length of the elongate portion of the first medical device for sensing a shape thereof; generating the external magnetic field with a magnetic interrogator including a plurality of magnetic transducers, each EMR element of the EMR elements being responsive to the external magnetic field, and the EMR elementsDocket No. 101672.0632PCT including that of an optional second medical device including an elongate portion and at least one EMR element; transducing responses of the EMR elements to the external magnetic field, thereby generating time-dependent location data for the EMR elements set in a magnetic interrogator-based coordinate system of a system-based reference frame defined by the plurality of magnetic transducers; registering with a registration process of the medical-device visualization processes the EMR elements including a distalmost EMR element of the first medical device at various magnetic transducers of the plurality of magnetic transducers; shape-sensing with a shape-sensing process of the medical-device visualization processes the shape of the elongate portion of the first medical device from the location data; and placing with a reference-framing process of the medical-device visualization processes the shape of the elongate portion of the first medical device in a patient-based reference frame following conversion of the location data from the magnetic interrogator-based coordinate system to a patient-based coordinate system in the patient-based reference frame.

13. The method of claim 12, further comprising converting with a coordinatesystem conversion process of the medical-device visualization processes the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system in the patient-based reference frame.

14. The method of either claim 12 or 13, wherein the patient-based reference frame is defined by a specific patient model established by one or more imaging techniques performed on the patient selected from ultrasound imaging, X-ray imaging, computed tomography (“CT”) scanning, and magnetic resonance imaging (“MRI”).

15. The method of either claim 12 or 13, wherein the patient-based reference frame is defined by a non-specific patient model fitted to the patient by measurements among various physical features of the patient.

16. The method of any claim of claims 12-15, wherein the first medical device is a catheter including a central venous catheter (“CVC”) or a peripherally inserted central catheterDocket No. 101672.0632PCT(“PICC”), and the plurality of passive EMR elements is distributed along at least a distal portion of a catheter tube of the catheter.

17. The method of any claim of claims 12-16, wherein the second medical device is present, the second medical device is a catheter introducer, and the at least one EMR element is about a proximal portion of an introducer sheath of the catheter introducer for indicating an insertion site on the patient.

18. The method of claim 17, wherein the registration process further registers the EMR elements including the at least one EMR element of the catheter introducer at the various magnetic transducers of the plurality of magnetic transducers, thereby registering a static location of the insertion site on the patient together with a dynamic location of the distalmost EMR element of the first medical device as the elongate portion thereof is advanced through the vasculature of the patient.

19. The method of claim 18, wherein the location of the insertion site on the patient provides a common local-extremum point between the magnetic interrogator-based coordinate system of the system-based reference frame and the patient-based coordinate system of the patient-based reference frame for converting the location data from the magnetic interrogatorbased coordinate system to the patient-based coordinate system.

20. The method of either claim 18 or 19, wherein locations of the plurality of transducers provide common local-minimum points between the magnetic interrogator-based coordinate system of the system-based reference frame and the patient-based coordinate system of the patient-based reference frame when the patient lies on or above the magnetic interrogator for converting the location data from the magnetic interrogator-based coordinate system to the patient-based coordinate system.

21. The method of any claim of claims 12-20, further comprising displaying with a medical-device displaying process of the medical-device visualization processes a graphical representation of the elongate portion of the first medical device within a patient avatar on a display screen.

22. The method of claim 21, wherein the medical-device displaying process further displays an insertion-site icon over the patient avatar.

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