Apparatus and method for determining sheath position using an on-sheath electromagnetic sensor - Patents.com

Abstract

To provide a medical tool for use with an electromagnetic navigation system.SOLUTION: A medical tool includes: a catheter configured to be navigated within a patient's anatomy; and at least one electromagnetic sensor, disposed at the catheter, configured to generate electrical signals indicative of a location of the catheter in response to receiving at least one magnetic field. The medical tool also includes: a sheath configured to receive the catheter; a first electromagnetic sensor and a second electromagnetic sensor, disposed at a first region of the sheath, each configured to generate electrical signals indicative of a location of the sheath in response to receiving the at least one magnetic field; and a third electromagnetic sensor, disposed at a second region of the sheath spaced from the first region, configured to generate electrical signals indicative of a location of the sheath in response to receiving the at least one magnetic field.SELECTED DRAWING: Figure 1

Description

[Background technology]

[0001] Electromagnetic navigation systems can be utilized to determine the location of medical instruments in three-dimensional (3D) space within a patient's body. For example, these electromagnetic navigation systems can include electromagnetic emitters and electromagnetic sensors on the instrument to determine the location of the instrument. Based on the determined location, anatomical information of the patient is displayed to medical personnel.

[0002] Some conventional navigation and display systems employ medical instruments including a catheter and a steerable and deflectable (i.e., bendable) sheath. For example, in some medical procedures, such as catheter ablation procedures, a catheter is guided through a patient's anatomy (e.g., via a blood vessel) to a target location (e.g., the heart) through a steerable and deflectable sheath. An example of the interaction between a catheter (e.g., a balloon catheter) and a sheath is described in U.S. Patent Application Serial No. 16 / 657,463, the teachings of which regarding the interaction of a catheter and a sheath during a medical procedure are incorporated herein by reference.

[0003] Due to potential risks associated with X-ray exposure, sheaths are placed during these medical procedures without the use of X-rays. For example, in some conventional systems, the position of the catheter is determined using electromagnetic-based navigation and displayed in a 3D volume, while the position of the sheath is determined via impedance-based navigation. Summary of the Invention [Means for solving the problem]

[0004] A medical instrument for use with an electromagnetic navigation system is provided that includes a catheter configured to be guided within a patient's anatomy and at least one electromagnetic sensor disposed on the catheter and configured to generate an electrical signal representative of the position of the catheter in response to receiving the at least one magnetic field. The medical instrument also includes a sheath configured to receive the catheter, a first electromagnetic sensor and a second electromagnetic sensor disposed in a first region of the sheath and each configured to generate an electrical signal representative of the position of the sheath in response to receiving the at least one magnetic field, and a third electromagnetic sensor disposed in a second region of the sheath spaced from the first region and configured to generate an electrical signal representative of the position of the sheath in response to receiving the at least one magnetic field.

[0005] A processing device for use with an electromagnetic navigation system is provided, the processing device including a memory configured to store data and a processor. The processor is configured to receive position signals from a first electromagnetic sensor disposed at a distal region of a deflectable portion of a sheath of a medical instrument, a second electromagnetic sensor disposed at a distal region of the deflectable portion of the sheath, a third electromagnetic sensor disposed at a proximal region of the deflectable portion of the sheath, and at least one electromagnetic sensor disposed on a catheter of the medical instrument. The processor is also configured to determine a position of the sheath based on the position signals from the first electromagnetic sensor, the second electromagnetic sensor, and the third electromagnetic sensor, and to determine a position of the catheter based on the position signals from the at least one electromagnetic sensor disposed on the catheter. The position of the sheath and the position of the catheter are displayed.

[0006] A method is provided for determining a position of a medical instrument in three-dimensional (3D) space using an electromagnetic navigation system. The method includes receiving position signals from a first electromagnetic sensor disposed at a distal region of a deflectable portion of a sheath of the medical instrument, a second electromagnetic sensor disposed at a distal region of the deflectable portion of the sheath, a third electromagnetic sensor disposed at a proximal region of the deflectable portion of the sheath, and at least one electromagnetic sensor disposed on a catheter of the medical instrument. The method also includes determining a position of the sheath based on the position signals from the first electromagnetic sensor, the second electromagnetic sensor, and the third electromagnetic sensor, and determining a position of the catheter based on the position signals from the at least one electromagnetic sensor disposed on the catheter. The position of the sheath and the position of the catheter are displayed. [Brief description of the drawings]

[0007] A more detailed understanding may be had from the following description, given by way of example in conjunction with the accompanying drawings, in which: [Figure 1] 1 is a schematic, pictorial illustration of an exemplary catheter position tracking system for tracking a catheter within a patient's heart in which exemplary embodiments disclosed herein may be implemented. [Diagram 2] FIG. 1 is a diagram of components of an exemplary electromagnetic navigation system for use with the exemplary embodiments described herein. [Diagram 3] FIG. 2 is a diagram of a portion of an exemplary deflectable (i.e., steerable) sheath that may be used to implement exemplary embodiments of the present invention. [Figure 4A] 4 is a side view of a portion of the exemplary sheath of FIG. 3 showing further details. [Figure 4B] 4B is a cross-sectional view of the deflectable portion of the sheath shown in FIG. 4A taken along line AA. [Diagram 5] FIG. 4B is a perspective view of a distal region of the deflectable portion of the sheath shown in FIG. 4A. [Figure 6] 1 is a flow diagram illustrating an exemplary method for determining a position of a medical instrument in 3D space using an electromagnetic navigation system according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Electromagnetic-based navigation is used to determine the position of the catheter in the 3D volume via electromagnetic emitters and electromagnetic sensors provided on the catheter. Impedance-based navigation is typically used to determine the position of the sheath when the design does not readily support the placement of electromagnetic sensors, such as the thin walls of the sheath. Impedance-based navigation is used to determine the position of the sheath via the current-emitting ring of the sheath and electrodes using electromagnetic position sensors (e.g., six patch sensors placed on the patient). However, impedance-based navigation determines the position of the sheath with less accuracy than the electromagnetic-based navigation system determines the position of the catheter. In addition, impedance-based navigation provides the position of the electrodes without yaw, pitch, or roll, whereas a single electromagnetic sensor provides five degrees of freedom (DOF), including position, as well as yaw and pitch. Furthermore, additional programming is required to correct for position errors of the sheath relative to the catheter.

[0009] The present application discloses a medical navigation system and a medical instrument for accurately determining the position of a catheter of a medical instrument and the position of a sheath of a medical instrument during a medical procedure using electromagnetic-based navigation. The present application includes a sheath having two or more electromagnetic sensors in a deflectable portion of the sheath to provide six DOF. In one embodiment, the sheath includes two electromagnetic sensors disposed in a distal region of the deflectable portion of the sheath, providing six degrees of freedom at the distal region, and a third electromagnetic sensor disposed in a proximal region of the deflectable portion of the sheath, providing five degrees of freedom at the proximal region. The position of the sheath is determined without additional programming used in conventional systems to correct for position errors of the sheath relative to the catheter.

[0010] FIG. 1 is a schematic pictorial diagram of an exemplary catheter position tracking system 20 for tracking a balloon catheter 40 within a patient's heart, according to an embodiment of the present invention. The balloon catheter 40 shown in FIG. 1 is merely one example of a type of catheter in which features of the present application may be implemented. Features of the present application may also be implemented using other types of catheters (e.g., basket catheters). The system 20 includes both an electrical position tracking subsystem and a magnetic position tracking subsystem. The system 20 is used to determine the position of the balloon catheter 40, seen in inset 25, mounted on the distal end of a shaft 22, and the extent to which the balloon is collapsed prior to an attempted balloon withdrawal through a sheath 23. Typically, the balloon catheter 40 is used in therapeutic procedures, such as spatially ablating cardiac tissue in the left atrium.

[0011] The balloon catheter 40 incorporates a proximal position sensor 50 and a distal position sensor 52 mounted on the shaft 22, on either side of the balloon. A sheath position sensor 54 is provided at the distal end of the catheter's sheath 23. The proximal position sensor 50 and distal position sensor 52 are connected to various drive circuits within the console 24 by wires that extend through the shaft 22. The sheath position sensor 54, provided at the distal portion of the sheath 23, is connected first by wires that pass through the sheath 23 and then to various drive circuits within the console 24.

[0012] Typically, the proximal position sensor 50, the distal position sensor 52, and the sheath position sensor 54 comprise either magnetic sensors or electrodes, which are used by the magnetic position tracking subsystem or the electrical position tracking subsystem, respectively, as described below. The physician 30 guides the balloon catheter 40 to a target location within the heart 26 of the patient 28 by manipulating the shaft 22 using the manipulator 32 near the catheter and / or deflection from the sheath 23. The balloon catheter 40 is inserted through the sheath 23 in a collapsed configuration, and only after the sheath 23 and subsequent balloon advancement member are retracted does the balloon catheter 40 regain its intended functional shape. By housing the balloon catheter 40 in a collapsed configuration, the sheath 23 also serves to minimize vascular trauma en route to the target location.

[0013] Console 24 is typically a general purpose computer and includes a processor 41 with appropriate front end and interface circuitry 44 for receiving signals from various sensors within and on the patient 28 .

[0014] In some exemplary embodiments, processor 41 precisely determines the position coordinates of proximal position sensor 50, distal position sensor 52, and sheath position sensor 54 within heart 26. Examples of processor coordinate systems may include those used by various position tracking systems, such as the electrical position tracking subsystem and magnetic position tracking subsystem described above.

[0015] In the exemplary embodiment, processor 41 determines position coordinates based on, among other inputs, the measured impedance between electrodes functioning as one or more position sensors 50, 52, and 54 and surface electrodes 49. Processor 41 is connected to surface electrodes 49, which in the exemplary system appear to be attached to the skin of patient 28, by wires that run through cable 39 to the chest of patient 28.

[0016] Methods of electrode position sensing using the electrical position tracking subsystem of system 20 have been implemented in a variety of medical applications, for example, using the Advanced Catheter Location (ACL) method in the CARTO™ system manufactured by Biosense Webster Inc. (Irvine, Calif.), and are described in detail in U.S. Pat. Nos. 7,756,576, 7,869,865, 7,848,787, and 8,456,182, which applications are incorporated by reference in their entireties herein.

[0017] The sensed electrode positions can be used to estimate the shape of multi-electrode catheters such as balloon catheters, basket catheters, LASSO™ catheters or NMARQ™ catheters (both manufactured by Biosense Webster), as well as other multi-electrode deflectable catheters, and also to estimate the degree of collapse (or straightening) of the respective disposable or deflectable distal end assemblies. Examples of catheters having end effectors in the form of lassos are shown and described in U.S. Pat. Nos. 9,788,893; 6,973,339; 8,475,450; 8,600,472; 9,050,010; 9,220,433; 9,848,948; 8,608,735; 7,371,232; and U.S. Patent Publication No. 20170100188, all of which are incorporated by reference as if fully set forth herein. Thus, with a known distance between the proximal sensor and the sheath sensor, the ACL method can be used with the disclosed exemplary embodiments of the present invention that do not include a distal position sensor to detect the event of the extendable distal tip assembly being retracted into the sheath while still at least partially extended or deflected.

[0018] For example, the aforementioned U.S. Patent No. 8,456,182, which uses a "local scaling" process hereinafter referred to as "independent current location" (ICL), is applicable to a catheter having multiple sensing electrodes disposed on its distal end. Using a known spatial relationship between two or more electrodes, e.g., one or more known distances between the electrodes, the ICL process can scale the relative positions of the multiple electrodes to accurately estimate the shape of the catheter's extendable distal tip assembly.

[0019] In some exemplary embodiments, the disclosed method uses a sheath position sensor and a proximal position sensor having shapes derived from the ACL and ICL of the extendable distal end assembly to detect the event of the extendable distal end assembly being retracted into the sheath while still at least partially extended or deflected. In such exemplary embodiments, the distal position sensor may be omitted. In general, there may be numerous techniques for estimating the shape of the extendable distal end assembly (specifically, estimating the degree to which the distal end assembly is extended). As another example, the shape may be estimated using a magnetic position sensor provided on the extendable distal end assembly. For example, U.S. Patent Application No. 16 / 198,487, entitled "Configuring Perimeter of Balloon Electrode as Location Sensor" and filed on November 21, 2018, which is incorporated herein by reference, describes multiple magnetic coils provided on a balloon to function as location sensors.

[0020] In U.S. Patent Application Serial No. 16 / 198,487, the spatial configuration of an expandable balloon within an organ is estimated. Here, it is noted that the estimation may include estimating at least one of the deflection of the balloon relative to a longitudinal axis defined by the distal end of the shaft and estimating the shape of the balloon within the organ. The step of estimating the shape may include identifying the degree of stretching of the balloon or detecting whether the balloon is fully stretched. In one embodiment, the balloon shape is estimated in the form of a "distension index" that gives the level of balloon inflation in a dimensionless number. Similarly, a stretch index is provided for any expandable distal end assembly.

[0021] As mentioned above, system 20 further comprises a magnetic sensing subsystem. Patient 28 is placed in a magnetic field generated by a pad that includes a magnetic field generator coil 42 driven by unit 43. The magnetic field generated by coil 42 generates signals in any magnetic position sensors which are then provided as corresponding electrical inputs to processor 41 which uses these to calculate the position of any of magnetic sensor-containing position sensors 50, 52 and 54.

[0022] Methods of position sensing using external magnetic fields have been implemented in various medical applications, such as the CARTO™ system manufactured by Biosense Webster Inc., and are described in detail in U.S. Pat. Nos. 5,391,199; 5,558,091; 6,172,499; 6,177,792; 6,788,967 and 6,690,963, as well as WO 96 / 05768, the disclosures of which are incorporated herein by reference.

[0023] Using the tracked positions, console 24 may drive display 27 showing the distal end of the catheter position within heart 26. Processor 41 is programmed, typically with software, to carry out the functions described herein. The software may be downloaded in electronic form to a computer, for example over a network, or alternatively or additionally may be provided and / or stored on a non-transitory tangible medium, such as magnetic, optical or electronic memory. In particular, processor 41 runs dedicated algorithms that enable processor 41 to perform the disclosed steps.

[0024] 1 is merely an exemplary system in which the embodiments disclosed herein may be implemented. Other electrically-based localization systems and methods can be used, such as, for example, a system in which a voltage gradient is applied between surface electrodes 49 and a location signal is derived from the resulting voltage measurements of internal electrodes.

[0025] Exemplary techniques for estimating the degree of elongation of an expandable assembly are described in U.S. patent application Ser. No. 16 / 234,604, entitled "Finding Elongation of Expendable Distal End of Catheter," filed Dec. 28, 2018, the disclosure of which is incorporated herein by reference.

[0026] FIG. 2 is a block diagram illustrating exemplary components of a medical system 200 for use with exemplary embodiments described herein. As shown in FIG. 2, the system 200 includes a medical instrument 201, a processing unit 204, a display unit 206, and a memory 212. The medical instrument 201 includes a catheter 202 and a sheath 220. The catheter 202 includes a catheter electrode 208 and a sensor 216, and is used, for example, to map electrical potentials (e.g., of the heart), to ablate a portion (e.g., tissue) within a patient's anatomy, or to both map and ablate electrical potentials. For example, the sheath 220 is steerable and deflectable, for example, to facilitate catheter access, stability, and tissue contact at a target site within the patient's anatomy. For example, during surgery, the catheter 202 is guided within the patient's anatomy (e.g., via a blood vessel) to a target location (e.g., the heart) through the steerable and deflectable sheath 220.

[0027] 2, the processing unit 204, display unit 206, and memory 212 are part of an exemplary computing device 214. In some exemplary embodiments, the display unit 206 may be separate from the computing device 214. The computing device 214 may further include an I / O interface, such as I / O interface 42 of FIG.

[0028] 2, catheter 202 includes one or more sensors 216 including, for example, magnetic field position sensors (i.e., electromagnetic sensors) for providing position signals to indicate 3D position coordinates of catheter 202. Sensors 216 may also include, for example, position sensors, pressure or force sensors, temperature sensors, and impedance sensors. The position signals are processed as position data and stored, for example, in memory 212. Processing unit 204 receives (e.g., reads from memory) the position data corresponding to the position signals and generates mapping information from the position data to display one or more maps of the organ of interest.

[0029] In some exemplary embodiments, the sensors 216 may also include sensors used during the ablation procedure to sense ablation parameters, such as catheter position stability, temperature, ablation time, ablation power, and ablation impedance during the ablation procedure. In the example shown in Figure 2, the catheter 202 also includes catheter electrodes 208 for mapping cardiac electrical potentials. The catheter 202 may be in wired or wireless communication with the processing unit 204 to communicate information acquired by the sensors 216.

[0030] 2, the sheath 220 includes a sheath sensor 218. For example, as described in more detail below, the sheath sensor 218 can include two electromagnetic sensors disposed at a distal region of the deflectable portion of the sheath 220 and a third electromagnetic sensor disposed at a proximal region of the deflectable portion of the sheath 220.

[0031] In some exemplary embodiments, one or more additional sensors 210 separate from the medical instrument 201 are also used to provide a position signal.

[0032] The processing device 204 uses the mapping information to drive the display device 206 to display a map of the organ on the display device 206. The display device 206 may include one or more displays, each configured to display one or more maps of the organ. For example, the display device 206 is configured to display a map representing the spatiotemporal expression of the organ (e.g., the heart) along with a geometric object representing the ablation estimated depth and width. The display device 206 may be in wired or wireless communication with the processing device 204. In some exemplary embodiments, the display device may be separate from the computing device 214.

[0033] Memory 212 includes, for example, volatile memory and non-volatile memory, such as random access memory (RAM), dynamic RAM, or cache. Memory 212 also includes storage 214, for example, fixed storage (e.g., hard disk drives and solid state drives) and removable storage (e.g., optical disks and flash drives).

[0034] 3 is a diagram of a portion of an exemplary deflectable (i.e., steerable) sheath 203 that may be used to implement features of the present disclosure. The sheath 203 is configured to be inserted into and guided within a patient's anatomy by an operator (e.g., a physician). The catheter 202 may be guided through the sheath 203 into a portion of the patient's anatomy (e.g., the heart). As shown in FIG. 3, the sheath 203 includes a deflectable portion 302 and a non-deflectable portion 304. To illustrate the steerable movement of the sheath 203, multiple states of the deflectable portion 302 of the sheath 203 are shown in FIG. 3. For simplicity, six different states are shown in FIG. 3.

[0035] FIG 4A is a side view of a portion of the exemplary sheath 203 of FIG 3 with further details shown. FIG 4B is a cross-sectional view of the deflectable portion 302 of the sheath 203 shown in FIG 4A along line AA. As shown in FIG 4B, the sheath 203 has a cylindrical shape and includes an inner surface 406 and an outer surface 408. The cylindrical shape of the sheath 203 shown in FIG 4B is merely an example. For simplicity, a catheter is not shown in FIG 4A and FIG 4B. However, during surgery, the catheter 202 is guided through the sheath 203 and within the patient's anatomy to a target location (e.g., the heart).

[0036] As shown in FIG. 4A, the deflectable portion 302 of the sheath 203 includes a distal region 402 and a proximal region 404. To facilitate accurate determination of the position, orientation, and shape of the sheath 203 using electromagnetic-based navigation, the sensor 218 of the sheath includes two separate electromagnetic sensors 410 and 412 disposed at the distal region 402 of the deflectable portion 302 of the sheath 203 and a third electromagnetic sensor 414 disposed at the proximal region 404 of the deflectable portion 302 of the sheath 203. The positions of the distal region 402 and the proximal region 404 relative to each other shown in FIG. 4A are merely examples. In addition, the positions of the distal region 402 and the proximal region 404 relative to the end of the sheath shown in FIG. 4A are also examples. The sensors 410, 412, and 414 are disposed on the sheath such that the approximate distance between the first two sensors and the third sensor includes a distance range of 10 mm to 150 mm.

[0037] In addition, the locations of electromagnetic sensors 410, 412, and 414 in corresponding regions 402 and 404 in Figure 4A are shown for illustrative purposes and are merely examples. As described in more detail below in connection with Figure 5, sensors 410, 412, and 414 are provided on sheath 203 such that their orientation and location on sheath 203 provides for accurate determination of position, orientation, and curvature in 3D space.

[0038] 5 is a perspective view of the distal region 402 of the deflectable portion 302 of the sheath 203 shown in FIG. 4A. As shown in FIG. 5, a first electromagnetic sensor 410 is provided on the outer surface 408 of the sheath 203 in the distal region 402, and a second electromagnetic sensor 412, spaced apart from the first electromagnetic sensor 410, is provided in the distal region 402. The electromagnetic sensors 410 and 412 are both oriented perpendicular to the Z direction but not parallel to each other. This allows for the calculation of all six DOFs of the assembly comprising the sensors 410 and 412. The orientation and position of the electromagnetic sensors 410, 412, and 414 provide six DOFs of the distal region 402 and five DOFs of the base, which is sufficient to accurately determine the position and orientation of the sheath 203 and the curvature of the sheath 203.

[0039] FIG. 6 is a flow diagram illustrating an exemplary method for determining the position of a medical device catheter and the position of a medical device sheath in 3D space using an electromagnetic navigation system.

[0040] As shown in block 602 of method 600, the method includes generating a magnetic field. For example, a magnetic field generator at a location external to the patient generates a magnetic field within a predetermined working volume that encompasses a portion of the patient's anatomy of interest. Each of the emitting coils can be driven at a different frequency to emit the magnetic field in 3D space.

[0041] As shown in block 604 of method 600, the method includes navigating a medical instrument within the patient's anatomy. For example, during a medical procedure such as catheter ablation, a medical instrument including both a catheter and a steerable sheath is guided through the sheath and into the patient's anatomy to a target location (e.g., the heart).

[0042] As shown in blocks 606-612, the position of the catheter and sheath is determined using electromagnetic-based navigation. As shown in block 606 of method 600, position signals are received from electromagnetic sensors on the sheath. For example, position signals are received from first and second electromagnetic sensors disposed at a distal region of the deflectable portion of the sheath, and a position signal is received from a third electromagnetic sensor disposed at a proximal region of the deflectable portion of the sheath. As shown in block 608 of method 600, position signals are received from at least one electromagnetic sensor disposed on a catheter of the medical instrument. Each of the position signals is generated based on the amplitude and frequency of a magnetic field to determine the position of the catheter in 3D space. For example, three different magnetic fields (from three different coils each operating at a slightly different frequency) are used to triangulate the electromagnetic sensors.

[0043] As shown at block 610 of method 600, the method includes determining a position of the sheath based on the position signals received from the first, second, and third electromagnetic sensors. As shown at block 612, the method includes determining a position of the catheter based on the position signals received from at least one electromagnetic sensor disposed on the catheter.

[0044] As indicated at block 614 of method 600, the method includes displaying the positions of the catheter and sheath. For example, mapping information is generated from each of the position signals and the positions of the catheter and sheath are displayed on a display.

[0045] The provided methods can be implemented in a general purpose computer, processor, or processor core. Suitable processors include, by way of example, a general purpose processor, a special purpose processor, a conventional processor, a digital signal processor (DSP), multiple microprocessors, one or more microprocessors associated with a DSP core, a controller, a microcontroller, an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA) circuit, any other type of integrated circuit (IC), and / or a state machine. Such a processor can be manufactured by configuring a manufacturing process using the results of processed hardware description language (HDL) instructions and other intermediate data such as a netlist (such instructions can be stored in a computer readable medium). The result of such processing can be a mask work that is then used in a semiconductor manufacturing process to manufacture a processor implementing the features of the present disclosure.

[0046] The methods or flow charts provided herein may be implemented in a computer program, software, or firmware embodied in a non-transitory computer-readable storage medium for execution by a general purpose computer or processor. Examples of non-transitory computer-readable storage media include read only memory (ROM), random-access memory (RAM), registers, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, and optical media such as CD-ROM disks and digital versatile disks (DVDs).

[0047] It should be understood that many variations are possible based on the disclosure herein, and although features and elements have been described above in specific combinations, each feature or element may be used alone without the other features and elements, or in various combinations with other features and elements, with or without the other features and elements.

[0048] [Embodiment] (1) A medical device for use with an electromagnetic navigation system, comprising: a catheter configured to be navigated within a patient's anatomy; at least one electromagnetic sensor disposed on the catheter and configured to generate an electrical signal indicative of a position of the catheter in response to receiving at least one magnetic field; a sheath configured to receive the catheter; a first electromagnetic sensor and a second electromagnetic sensor disposed in a first region of the sheath, each configured to generate an electrical signal indicative of a position of the sheath in response to receiving the at least one magnetic field; a third electromagnetic sensor disposed in a second region of the sheath spaced from the first region and configured to generate an electrical signal indicative of a position of the sheath in response to receiving the at least one magnetic field; and A medical device comprising: (2) The medical device described in embodiment 1, wherein the first electromagnetic sensor and the second electromagnetic sensor are provided in a distal region of the deflectable portion of the sheath, and the third electromagnetic sensor is provided in a proximal region of the deflectable portion of the sheath. (3) The medical device of embodiment 1, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to electromagnetic wave detection is non-parallel to a second direction in which the second electromagnetic sensor is sensitive to electromagnetic wave detection. (4) The medical device of embodiment 1, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to electromagnetic wave detection is perpendicular to a second direction in which the second electromagnetic sensor is sensitive to electromagnetic wave detection. (5) The medical device of embodiment 1, wherein the first electromagnetic sensor and the second electromagnetic sensor provide six degrees of freedom at the distal region of the deflectable portion of the sheath, and the third electromagnetic sensor provides five degrees of freedom at the proximal region of the deflectable portion of the sheath.

[0049] (6) A processing device for use with an electromagnetic navigation system, comprising: a memory configured to store data; 1. A processor comprising: Position signal, a first electromagnetic sensor disposed in a distal region of a deflectable portion of a sheath of the medical instrument; a second electromagnetic sensor disposed in the distal region of the deflectable portion of the sheath; a third electromagnetic sensor disposed in a proximal region of the deflectable portion of the sheath; and At least one electromagnetic sensor provided on a catheter of the medical device. Received from determining a position of the sheath based on the position signal from the first electromagnetic sensor, the position signal from the second electromagnetic sensor, and the position signal from the third electromagnetic sensor; determining a position of the catheter based on the position signal from the at least one electromagnetic sensor disposed on the catheter The processor and Equipped with the position of the sheath and the position of the catheter are displayed; Processing unit. (7) The processing device of embodiment 6, wherein the processor is further configured to generate mapping information to display the position of the sheath and the position of the catheter. (8) The processor: determining a curvature of an outer surface of the sheath based on the position signal from the first electromagnetic sensor, the position signal from the second electromagnetic sensor, and the position signal from the third electromagnetic sensor; Generate mapping information to indicate the position of the sheath and the curvature of the sheath 7. The processing device of claim 6, further configured as follows: (9) A processing device as described in embodiment 6, wherein the first electromagnetic sensor and the second electromagnetic sensor are provided in a distal region of the deflectable portion of the sheath, and the third electromagnetic sensor is provided in a proximal region of the deflectable portion of the sheath. (10) A processing device as described in embodiment 6, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to electromagnetic wave detection is non-parallel to a second direction in which the second electromagnetic sensor is sensitive to electromagnetic wave detection.

[0050] (11) A processing device as described in embodiment 6, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to electromagnetic wave detection is perpendicular to a second direction in which the second electromagnetic sensor is sensitive to electromagnetic wave detection. (12) A processing device as described in embodiment 6, wherein the first electromagnetic sensor and the second electromagnetic sensor provide six degrees of freedom at the distal region of the deflectable portion of the sheath, and the third electromagnetic sensor provides five degrees of freedom at the proximal region of the deflectable portion of the sheath. (13) A method for determining a position of a medical instrument in three-dimensional (3D) space using an electromagnetic navigation system, the method comprising: Position signal, a first electromagnetic sensor disposed in a distal region of a deflectable portion of a sheath of the medical instrument; a second electromagnetic sensor disposed in the distal region of the deflectable portion of the sheath; a third electromagnetic sensor disposed in a proximal region of the deflectable portion of the sheath; and At least one electromagnetic sensor provided on a catheter of the medical device. and determining a position of the sheath based on the position signal from the first electromagnetic sensor, the position signal from the second electromagnetic sensor, and the position signal from the third electromagnetic sensor; determining a position of the catheter based on the position signal from the at least one electromagnetic sensor disposed on the catheter; Including, the position of the sheath and the position of the catheter are displayed; method. (14) The method of claim 13, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to detecting electromagnetic waves is non-parallel to a second direction in which the second electromagnetic sensor is sensitive to detecting electromagnetic waves. (15) The method of claim 13, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to detecting electromagnetic waves is non-parallel to a second direction in which the second electromagnetic sensor is sensitive to detecting electromagnetic waves.

[0051] (16) The method of claim 13, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to detecting electromagnetic waves is perpendicular to a second direction in which the second electromagnetic sensor is sensitive to detecting electromagnetic waves. (17) The method of embodiment 13, wherein the first electromagnetic sensor and the second electromagnetic sensor provide six degrees of freedom at the distal region of the deflectable portion of the sheath, and the third electromagnetic sensor provides five degrees of freedom at the proximal region of the deflectable portion of the sheath.

Claims

1. 1. A medical device for use with an electromagnetic navigation system, comprising: a catheter configured to be navigated within a patient's anatomy; at least one electromagnetic sensor disposed on the catheter and configured to generate an electrical signal indicative of a position of the catheter in response to receiving at least one magnetic field; a sheath configured to receive the catheter; a first electromagnetic sensor and a second electromagnetic sensor disposed in a first region of the sheath, each configured to generate an electrical signal indicative of a position of the sheath in response to receiving the at least one magnetic field; a third electromagnetic sensor disposed in a second region of the sheath spaced from the first region and configured to generate an electrical signal indicative of a position of the sheath in response to receiving the at least one magnetic field; Equipped with the sheath is cylindrical in shape and includes an inner surface and an outer surface; the first electromagnetic sensor, the second electromagnetic sensor, and the third electromagnetic sensor are disposed at different positions on the outer surface of the sheath in a circumferential direction of the sheath, the first electromagnetic sensor and the second electromagnetic sensor are disposed at a distal region of the deflectable portion of the sheath, and the third electromagnetic sensor is disposed at a proximal region of the deflectable portion of the sheath; the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to detecting electromagnetic waves is non-parallel to a second direction in which the second electromagnetic sensor is sensitive to detecting electromagnetic waves; The medical device, wherein the first electromagnetic sensor and the second electromagnetic sensor provide six degrees of freedom at the distal region of the deflectable portion of the sheath, and the third electromagnetic sensor provides five degrees of freedom at the proximal region of the deflectable portion of the sheath.

2. 2. The medical instrument of claim 1, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to electromagnetic wave detection is orthogonal to a second direction in which the second electromagnetic sensor is sensitive to electromagnetic wave detection.

3. 1. A processing device for use with an electromagnetic navigation system, comprising: a memory configured to store data; 1. A processor comprising: Position signal, a first electromagnetic sensor disposed in a distal region of the deflectable portion of the sheath of the medical instrument; a second electromagnetic sensor disposed at the distal region of the deflectable portion of the sheath; a third electromagnetic sensor disposed in a proximal region of the deflectable portion of the sheath; and At least one electromagnetic sensor provided on a catheter of the medical device. Received from determining a position of the sheath based on the position signal from the first electromagnetic sensor, the position signal from the second electromagnetic sensor, and the position signal from the third electromagnetic sensor; determining a position of the catheter based on the position signal from the at least one electromagnetic sensor disposed on the catheter The processor and Equipped with the position of the sheath and the position of the catheter are displayed; the sheath is cylindrical in shape and includes an inner surface and an outer surface; the first electromagnetic sensor, the second electromagnetic sensor, and the third electromagnetic sensor are disposed at different positions on the outer surface of the sheath in a circumferential direction of the sheath, the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to detecting electromagnetic waves is non-parallel to a second direction in which the second electromagnetic sensor is sensitive to detecting electromagnetic waves; the first electromagnetic sensor and the second electromagnetic sensor provide six degrees of freedom at the distal region of the deflectable portion of the sheath, and the third electromagnetic sensor provides five degrees of freedom at the proximal region of the deflectable portion of the sheath. Processing unit.

4. The processing device of claim 3 , wherein the processor is further configured to generate mapping information to indicate the position of the sheath and the position of the catheter.

5. The processor, determining a curvature of the outer surface of the sheath based on the position signal from the first electromagnetic sensor, the position signal from the second electromagnetic sensor, and the position signal from the third electromagnetic sensor; Generate mapping information to indicate the position of the sheath and the curvature of the sheath The processing device of claim 3 further configured to:

6. 4. The processing device of claim 3, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to detecting electromagnetic waves is orthogonal to a second direction in which the second electromagnetic sensor is sensitive to detecting electromagnetic waves.

7. 1. A method for determining a position of a medical instrument in three-dimensional (3D) space using an electromagnetic navigation system, the method comprising: Position signal, a first electromagnetic sensor disposed in a distal region of a deflectable portion of a sheath of the medical instrument; a second electromagnetic sensor disposed at the distal region of the deflectable portion of the sheath; a third electromagnetic sensor disposed in a proximal region of the deflectable portion of the sheath; and At least one electromagnetic sensor provided on a catheter of the medical device. and determining a position of the sheath based on the position signal from the first electromagnetic sensor, the position signal from the second electromagnetic sensor, and the position signal from the third electromagnetic sensor; determining a position of the catheter based on the position signal from the at least one electromagnetic sensor disposed on the catheter; Including, the position of the sheath and the position of the catheter are displayed; the sheath is cylindrical in shape and includes an inner surface and an outer surface; the first electromagnetic sensor, the second electromagnetic sensor, and the third electromagnetic sensor are disposed at different positions on the outer surface of the sheath in a circumferential direction of the sheath, the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to detecting electromagnetic waves is non-parallel to a second direction in which the second electromagnetic sensor is sensitive to detecting electromagnetic waves; the first electromagnetic sensor and the second electromagnetic sensor provide six degrees of freedom at the distal region of the deflectable portion of the sheath, and the third electromagnetic sensor provides five degrees of freedom at the proximal region of the deflectable portion of the sheath. method.

8. 8. The method of claim 7, wherein the first electromagnetic sensor and the second electromagnetic sensor are oriented such that a first direction in which the first electromagnetic sensor is sensitive to detecting electromagnetic waves is orthogonal to a second direction in which the second electromagnetic sensor is sensitive to detecting electromagnetic waves.

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