Patent Description:
This disclosure is generally directed to a system for localizing medical devices within a patient, and more particularly to utilizing optical sensors in combination with one or more other localization systems.

Localization systems are utilized to allow physicians/technicians to visualize the location and/or orientation of a medical device with respect to imaging associated with the patient. For example, electrophysiology catheters are used in a variety of diagnostic, therapeutic, and/or mapping and ablative cardiology procedures to diagnose and/or correct conditions such as atrial arrhythmias, including for example, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. During a procedure, a catheter or catheter sheath is deployed and manipulated through a patient's vasculature to the intended site, for example, a site within a patient's heart. In order to improve the overall procedure and outcome, it is desirable for an operator to know the position and orientation of the catheter as it is navigated within the body of the patient in order to minimize physical injury to the tissues surrounding the desired organ and ensure that the device reaches its intended target.

Some general methods for localizing medical devices within the patient use fluoropaque markers such as a metallic coil or polymer having a percentage of Barium Sulphate (BaSO4) detected using X-ray fluoroscopy techniques. However, it is desirable to limit patient exposure to X-ray, and therefore it would be beneficial to reduce and/or eliminate reliance of X-ray fluoroscopy techniques. Additional techniques for localizing medical devices include one or more of magnetic, electrical, and/or ultrasound techniques. For example, one type of localization system is an electrical impedance-based system that includes one or more pairs of body surface electrodes (e.g., patches) outside a patient's body, a reference sensor (e.g., another patch) attached to the patient's body, and one or more sensors (e.g., electrodes) attached to the medical device. The pairs can be adjacent, linearly arranged, or associated with respective axes of a reference frame for such a positioning system. The system can determine position and/or orientation by applying a current across pairs of electrodes, measuring respective voltages induced at the device electrodes (i.e., with respect to the reference sensor), and then processing the measured voltages/impedances to determine the location of the device electrodes within the reference frame defined by the external electrodes.

Another system is known as a magnetic field-based system. This type of system generally includes one or more magnetic field generators attached to or placed near the patient bed or other component of the operating environment and one or more magnetic field detection coils coupled with a medical device. The generators provide a controlled low-strength AC magnetic field in the area of interest (i.e., an anatomical region). In response to the magnetic field, the detection coils produce a signal indicative of one or more characteristics of the sensed field. The system then processes these signals to produce one or more position and/or orientation readings associated with the coils (and thus with the medical device). The position and/or orientation readings are typically taken with respect to the field generators, and thus the field generators serve as the de facto "origin" of the reference frame of a magnetic field-based positioning system.

<CIT> relates to systems and methods for navigating a patient anatomy to conduct minimally invasive procedure for dynamically deforming an anatomical passageway model for a display.

According to one aspect, a medical device comprising may include a proximal end, a distal end, and a shaft extending between the proximal end and the distal end. The medical device may further include a magnetic sensor assembly that may include a magnetic coupler and first and second magnetic sensors, wherein the magnetic coupler is located at the distal end of the medical device and is rigidly affixed to an inner surface of the shaft. The medical device may further include an optical fiber comprised of a plurality of fiber cores extending along a length of the shaft, wherein one or more of the plurality of fiber cores include an optical sensor located at a location along a length of the optical fiber, wherein the optical fiber is rigidly supported within the shaft at a location near the optical sensor.

According to another aspect, a localization system may include a medical device having a proximal end and a distal end, wherein the distal end may include at least a first localization sensor and an optical sensor, wherein the first localization sensor and the optical sensor may be rigidly affixed within the distal end of the medical device. The localization system may further include a computer system configured to receive feedback from the first localization sensor and optical feedback from the optical sensor, wherein the computer system may be utilized to determine the position of the distal end of the medical device within a first reference frame based on the received feedback and may determine the shape of the distal end of the medical device within a second reference frame based on the optical feedback, wherein the computer system may transform the shape of the distal end of the medical device from the second reference frame to the first reference frame based, at least in part, on the position of the distal end of the medical device. An output generated by the computer system may include a position and shape of the distal end of the medical device expressed in the first reference frame.

According to another aspect, a method of localizing a medical device within a patient may include receiving feedback from a first localization sensor and receiving optical feedback from an optical sensor. The method may further include calculating a position of the first localization sensor based on the received feedback, wherein the position is provided with respect to a first reference frame defined by the first localization sensor. The method may further include calculating a shape of the optical sensor based on the optical feedback from the optical sensor, wherein the shape is provided with respect to a second reference frame defined with respect to the optical sensor. The method may further include transforming the shape of the optical sensor from the second reference frame to the first reference frame based on the position of the first localization sensor and stored transformation coefficients. The method may further include displaying the position and shape of the medical device with respect to the first reference frame.

According to another aspect, a method of calibrating an optical sensor with a magnetic localization sensor in a distal end of a medical device may include placing the distal end of a medical device within a magnetic field and placing the distal end of the medical device is a first position, wherein the first position causes a deflection of the optical sensor. The method may further include recording first magnetic position data provided by the magnetic localization sensor and first optical data provided by the optical sensor and storing the recorded data as a first fiducial pair, wherein the first magnetic position data is provided in a magnetic reference frame and the first optical data is provided in an optical reference frame. The method may further include placing the distal end of the medical device in a second position, wherein the second position causes a deflection of the optical sensor and recording second magnetic position data provided by the magnetic localization sensor and second optical data provided by the optical sensor and storing the recorded data as a second fiducial pair, wherein magnetic position data is provided in the magnetic reference frame and the optical data is provided in the optical reference frame. The method may further include calculating a transformation based on the first and second fiducial pairs to transform optical shape data from the optical reference frame to the magnetic reference frame and storing the calculated transformation.

According to another aspect, a medical device may include comprising a proximal end, a distal end, a handle connected to the proximal end, and a shaft extending between the proximal end and the distal end. The medical device may further include first and second magnetic sensors located in the handle and an optical fiber comprised of a plurality of fiber cores extending from the handle to the distal end of the medical device. The optical fiber may be comprised of one or more fiber cores, wherein one or more of the fiber cores includes a plurality of fiber Bragg grating (FBG) sensors located approximately adjacent to one another from the handle to the distal end of the medical device.

The present disclosure provides a system and method of correlating/displaying shape information received from the optical sensor(s) within the reference frame associated with the first localization system. In this way, the shape of the medical device may be displayed in the reference system of the first localization system. The medical device (e.g., interventional or surgical catheters, introducer, and other elongate medical devices) is equipped with one or more sensors utilized by a first localization system such as magnetic-, electrical impedance-, and/or ultrasound-based systems to localize of the medical device within the body of a patient. In addition, the medical device is equipped with one or more optical sensing technologies, such as fiber Bragg grating (FBG) sensors and/or optical interferometer distal force sensors utilized to detect the shape and/or forces applied to the medical device - or at least a portion of the medical device that includes the optical sensor. In general, optical sensors located on the medical device are configured to receive an optical input via an optical fiber, multi-core fiber, etc. capable of transmitting light signals, wherein information regarding the position, orientation and/or shape of the optical sensor is determined from light reflected by the sensor. The present disclosure provides a system and method of correlating/displaying shape information received from the optical sensor(s) within the reference frame associated with the first localization system.

<FIG> is an isometric view of a system <NUM> utilized in performing a medical procedure with respect to a patient P. In the embodiment shown in <FIG>, the system <NUM> includes a medical device, such as a catheter <NUM> shown in <FIG>, an introducer, or other surgical device including at least a portion of which is located within the body of the patient P. The catheter <NUM> includes a proximal end <NUM>, a distal end <NUM>, and a handle <NUM>. During a surgical procedure, the distal end <NUM> is placed within a region of interest within a patient - for example, within the vasculature of the patient - and navigated to a desired location within the body by a physician/technician via controls located on handle <NUM>. As described in more detail below, sensor feedback received from one or more sensors located on the catheter <NUM> - for example, at the distal end <NUM> of the catheter <NUM> - allows computer system <NUM> to determine the location, orientation, and/or shape of the catheter <NUM> and to display this information to the physician/technician via display <NUM>. In some embodiments, location, orientation, and/or shape of the catheter <NUM> is displayed with respect to patient imaging (e.g., MRI imaging, geometries created from mapping catheters, ultrasound catheters, etc.) of the patient. For example, in the embodiment shown in <FIG>, a C-ARM assembly <NUM> is illustrated, which may be utilized to generate x-ray imaging of a patient P. However, in other embodiments the catheter <NUM> may be utilized without an external imaging device such as C-Arm <NUM>.

In some embodiments, catheter <NUM> includes magnetic sensors (210a, 210b shown in <FIG>) utilized in a magnetic-based localization system to detect the position and/or orientation of the distal end <NUM> of the catheter <NUM> within the patient. In some embodiments, the magnetic sensors are located on the distal end <NUM> of the catheter <NUM> (for example, as shown in <FIG>, <FIG> and <FIG>). In other embodiments, the magnetic sensors are located within the handle <NUM> (for example, in the handle <NUM> shown in <FIG>). In embodiments utilizing a magnetic-based localization system, a magnetic field must be generated to interact with the magnetic sensors. For example, in some embodiments a magnetic transmitter assembly <NUM> is mounted to the underside of table <NUM> to produce the magnetic field required to interact with the magnetic sensors. In embodiments in which the magnetic sensors are located within the handle <NUM> of the catheter <NUM>, the handle <NUM> must be operated within the area in which the magnetic field is generated (i.e., in the area adjacent to the patient). In some embodiments, magnetic transmitter assembly <NUM> generates a low-level magnetic field. One or more magnetic sensors located in the catheter <NUM> (e.g., distal end <NUM>, handle <NUM>, etc.) interact with the low-level magnetic field and generate in response feedback that can be utilized to determine the position and/or orientation of the magnetic sensors within the region defined by the magnetic field. Feedback generated by the magnetic sensors is provided to the computer system <NUM> via magnetic sensor cable <NUM>, which interprets the received data and generates a display that allows the physician/technician to visualize the location and orientation of the catheter <NUM> within imaging of the patient's body via display <NUM>. In some embodiments, an external magnetic field (generated by magnetic transmitter assembly <NUM>) provides a reference for localizing the magnetic sensors within patient imaging and providing this information to display <NUM>. In other embodiments other types of well-known localization systems (e.g., electrical impedance-based systems, ultrasound-based systems, etc.) may be utilized.

In addition, one or more optical sensors provide feedback via fiber core cable <NUM> to computer system <NUM>. As described in more detail below, optical feedback is utilized to determine position, orientation, shape, and/or temperature of the catheter <NUM>. In particular, the shape information provided by the optical sensor provides information that is not provided by the magnetic-based localization system. However, the optical feedback received from the optical sensors is not referenced to any external field - only to itself. To utilize the shape information provided by the optical sensors, the position, orientation, and/or shape information determined from the optical feedback is converted to the reference frame utilized by the first localization system (e.g. magnetic-based system). As described in more detail below, in some embodiments the optical reference frame associated with the optical sensor is registered with the reference frame utilized by the magnetic sensors (or other sensor type), allowing optical feedback to take advantage of the reference frame defined by the magnetic-based localization system. In this way, position, orientation and/or shape information provided by the optical sensors is transformed (i.e., referenced) to a reference frame capable of displaying position, orientation, shape of the catheter <NUM> within the context of patient imaging data.

In some embodiments, the computer system <NUM> includes an electronic control unit (ECU) <NUM>, memory/storage <NUM>, an input/output device <NUM> and a display <NUM>. Memory/storage <NUM> stores instructions executable by the processor <NUM> to implement one or more modules, including a magnetic localization module <NUM> and an optical localization module <NUM>. In another embodiments, other localization systems may be utilized in place of or in conjunction with the magnetic localization system, including one or more of an electrical impedance-based system, ultrasound system, as well as other well-known localization systems.

Magnetic localization module <NUM> receives feedback from magnetic sensors located at the distal end <NUM> of the catheter <NUM>. The feedback provided by the magnetic sensors is a result of the one or more magnetic sensors interacting with the low-level magnetic field generated by the magnetic transmitter assembly <NUM>. In some embodiments, the location of the magnetic sensor is determined within a three-dimensional (3D) reference frame referred to herein as the magnetic reference frame. The output provided by magnetic localization module <NUM> is a position and/or orientation of the magnetic sensors within the magnetic coordinate frame. Optical sensor data received from the one or more optical sensors located in the catheter <NUM> are provided to optical localization module <NUM>. In some embodiments, the one or more optical sensors are located at the distal end <NUM> of catheter <NUM>. In other embodiments, optical sensors may be located at a plurality of locations associated with catheter <NUM>, and may be positioned adjacent or approximately adjacent to one another along the length of the catheter <NUM> (i.e., from the distal end <NUM> toward the proximal end <NUM>, in some cases along the entire length to the handle <NUM>). In addition, optical localization module <NUM> receives input regarding the position of the magnetic sensor within the magnetic coordinate frame and stored transformation coefficients. In some embodiments, a registration process is utilized to register the optical sensor with the magnetic sensor and generate the transformation coefficients utilized to convert positions from the optical reference frame to the magnetic reference frame. Based on the optical sensor data, the position of the magnetic sensor within the magnetic reference frame, and the stored transformation coefficients, the optical localization module <NUM> generates an output providing the location, orientation and/or shape of the optical sensor within the magnetic reference frame. In this way, the localization output provided with respect to the magnetic sensors and the optical sensors are both expressed within the magnetic reference frame and can be localized with respect to patient imaging data provided to display <NUM>. As described in more detail below, the location of the magnetic sensors may determine the number and location of optical sensors required to express the location, orientation and/or shape of the optical sensor with respect to the magnetic reference frame.

Referring to <FIG> and <FIG>, position, orientation, and shape of the medical device is determined within a magnetic reference frame <NUM> (shown in <FIG>) based on input received from one or more magnetic sensors (e.g., magnetic sensors 210a, 210b shown in <FIG>, magnetic sensors 810a, 810b shown in <FIG>) and input received from one or more optical sensors (e.g., optical sensors 300a, 300b, 300c shown in <FIG>), such as, for example, a fiber Bragg grating (FBG). As described in more detail below, the magnetic reference frame is based on the interaction of the magnetic sensors 210a, 210b (or 810a, 810b, shown in <FIG>) with an externally created magnetic field. The location and orientation of the magnetic sensors 210a, 210b are therefore known within the magnetic reference frame, and can be localized without additional input. In contrast, the optical reference frame <NUM> is referenced only to the optical sensor itself, not to any external magnetic field (or in the case of electrical impedance-based localization, to surface electrodes placed on the patient). To remedy the lack of an external reference point with respect to the optical reference frame <NUM>, the optical reference frame <NUM> is registered with the magnetic reference frame <NUM>. In some embodiments, the output of the registration process is a set of transformation coefficients unique to the medical device registered, wherein the transformation coefficients are utilized to transform feedback received from the one or more optical sensors 300a, 300b, 300c from the optical reference frame <NUM> to the magnetic reference frame <NUM>. As discussed in more detail below, registering the optical reference frame <NUM> utilized by the one or more optical sensors 300a, 300b, 300c with the magnetic reference frame <NUM> includes allowing position/shape information provided by the one or more optical sensors (e.g., FBGs 300a, 300b, 300c) to be displayed within the magnetic reference frame <NUM> utilized to localize the catheter <NUM> within patient imaging.

In the embodiment shown in <FIG>, a plurality of optical sensors 300a, 300b, 300c are located longitudinally along a portion of the multi-core fiber <NUM>, wherein one or more of the cores within the multi-core fiber <NUM> may include the one or more optical sensors 300a, 300b, 300c. In some embodiments, the one or more optical sensors 300a, 300b, 300c are fiber Bragg grating (FBG) sensors, which is a type of optical sensor capable of detecting applied forces, strains and/or changes in temperature. In some embodiments, a single core of the multi-core fiber <NUM> includes each of the plurality of optical sensors 300a, 300b, 300c. In addition, the one or more optical sensors may be utilized for a plurality of different functions. For example, one of the optical sensors 300a may be utilized for shape sensing while another of the optical sensors may be utilized for temperature. As described above, in some embodiments additional optical sensors may be positioned along the length of the catheter <NUM> (from the distal end <NUM> toward the proximal end <NUM>, in some cases extending to the handle <NUM>), wherein feedback received from the plurality of sensors allows for the shape of the length of the catheter to be calculated. In other embodiments, each of the plurality of optical sensors 300a, 300b, 300c may be utilized for shape sensing, wherein the plurality of optical sensors extend from the distal end <NUM> of the catheter <NUM> to the proximal end <NUM> of the catheter <NUM>, or to the handle <NUM> of the catheter <NUM>. In this way, the position and/or orientation of the ablation tip <NUM> and of the shaft <NUM> may be determined.

As described above, in some embodiments the one or more optical sensors 300a, 300b, 300c are fiber Bragg grating sensors - a type of distributed Bragg reflector that includes a periodic variation in the refractive index of a fiber core. The interface of each change in refractive index results in a reflection of incident light. Most reflections are relatively weak and light at these wavelengths is, for the most part, transmitted through the fiber Bragg grating. However, light at a certain resonance wavelength related to the periodic variation in the refractive index will be reflected by the fiber Bragg grating. The relationship between reflected light and the periodic variation in the refractive index of the fiber core is defined as: <MAT> wherein A is the period of the grating, neff is the fiber core effective index, and λβ is the Bragg wavelength at which resonance occurs. In this way, an optical signal transmitted along the core to the fiber Bragg grating will result in the reflection of a resonance wavelength λβ, which is related to the periodic variation of the fiber Bragg grating. A force, strain and/or change in temperature applied to the fiber grating will result in a change in the period of the grating that in turn causes a change in the wavelength of light reflected. By detecting the shift in wavelengths reflected by a fiber Bragg grating, information regarding force, strain and/or change in temperature applied to the sensor and/or shape (i.e., bending) of the sensor can be detected. In the instant disclosure, the focus is on the detection of force and/or shape applied to the catheter <NUM>, although in some embodiments one or more fiber cores may also be utilized to detect changes in temperature. Force detection may include force applied to the ablative tip along the axis of catheter as well as deflection forces that cause a bending of the catheter <NUM>. Depending on the location of the one or more FBGs, shape information may be collected with respect to specific portions of the catheter <NUM> (e.g., distal end <NUM> of the catheter as shown by the placement of one or more FBGs 300a, 300b, 300c) or along the length of the catheter <NUM>. For example, a plurality of FBGs may be positioned along the length of catheter <NUM> - extending from proximal end <NUM> or even handle <NUM> to distal end <NUM>.

When an axial or deflecting force is applied to the fiber grating, both the grating period and the fiber effective index will change accordingly, and hence the Bragg wavelength (e.g., the wavelength of light reflected back) will shift one way or another. By measuring the shift of the Bragg wavelength, the FBGs can be used for force and shape sensing (as well as temperature sensing). One advantage derives from the absolute nature of the information-encoding in measuring the wavelength shift, which renders the sensor independent from fluctuating light power or connector losses. With an applied strain ε and the ambient temperature change dT, the shift of the Bragg wavelength is obtained by taking the differential of Eq. <NUM> as shown in Eq. <NUM>: <MAT> where <MAT> is the photo-elastic constant, ρe = <NUM> for pure silica glass, α = <MAT> is the coefficient of linear expansion, <MAT> is the thermo-optic coefficient, and dT is the temperature change. For a grating at <NUM> wavelength, the wavelength shifts are typically of order ~<NUM> pm / µε for strain, and <NUM> pm/°C for temperature.

The Young's modulus E is defined as: <MAT> where, F is the force, A<NUM> is the area of the fiber cross section, L<NUM> is the fiber length and ΔL is stressed length due to the applied force. The force can be derived from Eq. (<NUM>) as: <MAT> where ε = ΔL/L<NUM> is the stain. For a single mode fiber with a diameter of <NUM>, the Young's modulus of the glass material is <NUM> × <NUM><NUM>N/m<NUM>, then the force with respect to the fiber strain is obtained as: <MAT> When the ambient temperature remains unchanged dT = <NUM>, for a pure glass ρe = <NUM>, per Eq. <NUM> and Eq. <NUM>, the applied force with respect to the shift of the Bragg wavelength is obtained as: <MAT> For a resolution of <NUM> Bragg wavelength shift in <NUM> wavelength band, the force resolution is given by Eq. <NUM> as <NUM> gram. Per Eq. <NUM> and <NUM>, the shift of Bragg wavelength with respect to the applied force and temperature change is expressed as <MAT> Where Δλ is the shift of Bragg wavelength, ΔT is the temperature change, F is the applied force, E is the Young's modulus, A<NUM> is the area of fiber cross section, ρe is the photo-elastic constant, α is the coefficient of linear expansion, and f is the thermo-optic coefficient.

To sense deflection forces in three-dimensions, a plurality of independent optical sensors may be used in one embodiment. For example, with reference to <FIG>, the multi-core fiber <NUM> includes a plurality (e.g., seven) individual fiber cores labeled 402a-<NUM> as illustrated, each fiber core including at least one FBG (not shown in <FIG>). In some embodiments, at least a first plurality of fiber cores (e.g., fiber cores 400a-400f) are positioned equidistantly along the outer circumference of the multi-core fiber <NUM>. A deflection force applied to the multi-core fiber causes some of the optical fibers to lengthen and some of the optical fibers to compress, and thus the feedback provided by some of the FBGs will illustrate a shift of wavelengths corresponding with a compression (i.e., shortening) of the FBG and at least some of the FBGs will illustrate a shift in wavelengths corresponding with a lengthening of the FBG. Based on the feedback, the amount of deflection and shape of the deflection may be determined. Although seven individual fiber cores are shown in <FIG>, in other embodiments fewer individual fiber cores may be required. For example, in some embodiments force and shape sensing is provided by three individual fiber cores located along an outer circumference of a multi-core fiber <NUM> and spaced equidistantly from one another (e.g., <NUM>° apart). Additionally, more than seven fiber cores in the multi-core fiber <NUM> are also contemplated.

In some embodiments, the plurality of fiber cores 400a-400f located around an outer circumference are each utilized to detect deflection forces applied to the FBG. In other embodiments, a first plurality of fiber cores located around the periphery (e.g., fiber cores 400a 400c, and 400e) are utilized for shape sensing while a second plurality of fiber cores located around the periphery (e.g., fiber cores 400b, 400d, and 400f) is utilized for axial force sensing. In general, it is desirable that the plurality of cores be spaced equidistantly around the periphery of the multi-core fiber to provide the maximum amount of information with respect to the shape of the sensor. In some embodiments, the central fiber core <NUM> is also utilized for detecting of forces - including axial and/or deflection forces. In other embodiments, the central fiber core <NUM> is utilized for temperature compensation/internal strain monitoring. Various other configurations may be utilized to detect deflection forces, axial forces, and/or temperature changes.

As described above, in some embodiments, rather than locating the one or more optical sensors 300a, 300b, 300c (e.g., FBG) at a particular location along the length of the multi-core fiber - for example as part of the ablation tip <NUM> shown in <FIG> and <FIG> - one or more of the fiber cores 402a-<NUM> may include a plurality of FBGs located along an axial length of the fiber core. For example, fiber core 400a may include a plurality of FBGs, each defined by a unique grating period. In some embodiments the plurality of FBGs are located adjacent one another (e.g., stacked end-to-end), with little or no gap between the adjacent FBGs. Each FBG provides feedback regarding the forces exerted on the FBG, wherin stacking a plurality of FBGs end-to-end provides shape information for a longer length of the catheter <NUM>. In some embodiments, shape information may be collected with respect to an axial length of the catheter <NUM> by placing a plurality of FBGs back-to-back. In some embodiments, the pluraltity of FBGs may extend from the distal end <NUM> of the catheter <NUM> toward the handle <NUM> - in some embodiments extending from the distal end <NUM> of the catheter <NUM> all the way to the handle <NUM>. In some embodiments, to distiniguish reflections provided by each of the pluraltiy of FBGs connected along the same fiber core, each of the FBGs must be characterized by a different grating period so that reflections received on the same fiber can be definitely assigned to one of the FBGs. In this way, optical sensor <NUM> provides feedback utilized to determine the shape of the optical sensor <NUM>.

<FIG> is a cross-sectional view of the distal end <NUM> of the catheter <NUM> taken along line <NUM>-<NUM> shown in <FIG>. In some embodiments, a magnetic sensor assembly includes magnetic coupler <NUM> and first and second magnetic sensors 210a, 210b. Magnetic coupler <NUM> is rigidly affixed to an inner surface of the shaft <NUM>. First and second magnetic sensors 210a, 210b are affixed to magnetic coupler <NUM>, wherein the magnetic coupler <NUM> retains the magnetic sensors 210a, 210b in fixed locations relative to the shaft <NUM> as well as with respect to one another. Although not shown in this view, magnetic signals detected by first and second magnetic sensors 210a, 210b, are communicated via magnetic sensor cable <NUM> (shown in <FIG>) to computer system <NUM>. Based on the rigid connection of the magnetic sensors 210a, 210b within the distal end <NUM> of catheter <NUM> and rigid location of the magnetic sensors 210a, 210b with respect to one another, the location and orientation of the distal end <NUM> of the catheter <NUM> is known with respect to a magnetic reference frame <NUM>. In the embodiment shown in <FIG>, the magnetic reference frame <NUM> is defined by principle axes (e.g., mX, mY, mZ) and orientation about these axes (e.g., yaw, pitch roll) is expressed as θ. Based on feedback provided by the magnetic sensors 210a, 210b, the absolute position and/or orientation of the distal end <NUM> of the catheter is known within the magnetic reference frame <NUM>.

In some embodiments, optical fiber <NUM> extends within an interior portion of the outer shaft <NUM> toward the distal end <NUM> of catheter <NUM>. In some embodiments, optical fiber <NUM> is a multi-core fiber including a plurality of fiber cores (as shown in <FIG>). Optical fiber <NUM> is rigidly secured within the distal end <NUM> of the catheter <NUM> by a fiber tube support member - illustrated here as first fiber tube support <NUM>, second fiber tube support <NUM> and third fiber tube support <NUM>. In some embodiments, first fiber tube support <NUM>, second fiber tube support <NUM> and third fiber tube support are integral (i.e., a single tube). In other embodiments, the first, second and third fiber tube supports are separate from one another. In some embodiments, first fiber tube support <NUM>, second fiber tube support <NUM> and third fiber tube support <NUM> act to rigidly affix the optical fiber <NUM> within the distal end <NUM> of the catheter <NUM>. In the embodiment shown in <FIG>, first fiber tube support <NUM>, second fiber tube support <NUM>, and third fiber tube support <NUM> act to support optical fiber <NUM> in an approximately central location within the distal end <NUM> of the catheter <NUM>. In other embodiments, optical fiber <NUM> may be retained within a non-central location of the catheter <NUM>, so long as the position of the optical fiber <NUM> remains fixed relative to the catheter <NUM>.

Within ablation tip <NUM>, the flex tip wall <NUM> and spring <NUM> allow ablation tip <NUM> to be compressed in an axial direction. In some embodiments, the flex tip wall <NUM> and spring <NUM> also allow the ablation tip <NUM> to deflect in non-axial directions (e.g., to bend). In some embodiments, flex tip wall <NUM> may be utilized without the inclusion of spring <NUM>. The first, second, and third fiber tube supports <NUM>, <NUM>, and <NUM> rigidly affix the optical fiber <NUM> to the catheter <NUM>, forcing the optical fiber <NUM> and in particular the optical sensor <NUM> to follow the orientation/shape of the ablation tip <NUM>. In addition, in some embodiments - to ensure rigidity between the optical fiber <NUM> and the catheter <NUM> - the optical fiber <NUM> is bonded to one or more of the first fiber tube support <NUM>, second fiber tube support <NUM>, and/or third fiber tube support <NUM> to ensure rigid connection of the optical sensor within the shaft <NUM>. As a result, the optical fiber <NUM> follows the movement and shape of the catheter <NUM> such that optical feedback received from the optical sensor <NUM> represents the shape and/or geometry of the catheter <NUM>.

In some embodiments, a plurality of individual optical sensors 300a, 300b, 300c (e.g., FBGs) may be utilized, within one or more associated with each of the plurality of cores. In the embodiment shown in <FIG>, optical sensor 300a is located at a most distal end of the optical fiber <NUM>, wherein optical sensor 300b is located adjacent to optical sensor 300a, and optical sensor 300c is located adjacent optical sensor 300b. In some embodiments, one or more of the optical sensors 300a, 300b, or 300c may be utilized for shape sensing or force sensing. For example, in some embodiments, optical sensor 300a may be utilized for force sensing, and optical sensors 300b and 300c are utilized for shape sensing. In other embodiments, each of the optical sensors 300a, 300b, and 300c are utilized for shape sensing. In embodiments in which each of the optical sensors 300a, 300b, 300c are located on the same fiber core, each of the plurality of FBGs may be designed to operate at a different wavelength, such that it is capable of providing feedback with respect to sensed strains/forces. In some embodiments, optical sensors 300a-300c may not be constrained to the region within or adjacent to ablation tip <NUM>. For example, in some embodiments a plurality of optical sensors or FBGs may be located end-to-end along one or more of the fiber cores from the ablation tip <NUM> to magnetic sensors 210a, 210b (for example, in the embodiment shown in <FIG>, a plurality of optical sensors 300a, 300b, 300c, 300d, and 300e extend from a distal tip of the catheter (300a) to the region adjacent to the magnetic sensors 210a, 210b). In other embodiments, a plurality of optical sensors (e.g., FBG sensors) may be located end-to-end along one or more of the fiber cores from the ablation tip <NUM> along the length of the catheter <NUM> to handle <NUM>. With respect to the embodiment shown in <FIG>, each of the plurality of FBGs 300a-300e - if operating on the same fiber core - may operate at different wavelengths than one another, such that strain/force sensed by each of the plurality of FBGs provides a reflection of light distinguishable from the other FBGs. In this way, feedback provided by the FBGs may be utilized to determine shape information from the magnetic sensors 210a, 210b to the tip of the catheter.

Shape and/or position information retrieved from the optical sensors <NUM> (provided with respect to the optical reference frame <NUM>) is translated to the magnetic reference frame <NUM> by registering the one or more optical sensors 300a-300c with the magnetic reference frame <NUM>. In some embodiments, because the magnetic sensors 210a, 210b are rigidly affixed to the distal end <NUM> of the catheter <NUM>, the magnetic sensors 210a, 210b and therefore the magnetic reference frame <NUM> is forced to follow the movements of the catheter <NUM>. The position/orientation of the catheter <NUM> (but not the shape) may therefore be derived from the magnetic sensors 210a, 210b and expressed with respect to the magnetic reference frame <NUM>. Likewise, the one or more optical sensors 300a-300c are rigidly affixed to the distal end <NUM> of the catheter <NUM>, the optical sensors 300a-300c are also forced to follow the movement of the catheter <NUM>. Registering the one or more optical sensors 300a-300c with respect to the magnetic reference frame <NUM> allows the magnetic reference frame <NUM> to be utilized as the reference point for the one or more optical sensors 300a-300c. That is, the position, shape and orientation of the one or more optical sensors 300a-300c is known relative to the position and orientation of the magnetic sensors 210a, 210b.

In the embodiment shown in <FIG>, the magnetic sensors 210a, 210b are located at the distal end <NUM> of the catheter <NUM>. In other embodiments, such as the embodiment shown in <FIG>, the magnetic sensors 810a, 810b are located in the handle <NUM> of the catheter. In this embodiment, the magnetic reference frame is based on the location of the handle <NUM>. The position and/or orientation of the distal end of the catheter may be determined based on the deployment of a plurality of optical sensors (e.g., FBGs) located along the length of the catheter between the handle <NUM> and a distal end of the catheter. As described above, each of the adjacent FBG sensors would operate at a different wavelength, allowing each to provide feedback. In particular, referencing the shape data provided by the plurality of optical sensors to the magnetic reference frame defined by the magnetic sensors located in the handle <NUM> allows for the position and orientation of the distal end <NUM> of the catheter <NUM> to be known.

Referring to <FIG> and <FIG>, a registration process is described for correlating the optical reference frame <NUM> to the magnetic reference frame <NUM>. Although reference is made to the magnetic reference frame <NUM>, in other embodiments other localization systems and corresponding reference frames may be utilized. In some embodiments, the registration process is performed at the time of manufacture. In other embodiments, the registration process if performed prior to each use to re-calibrate the optical reference frame <NUM> with the magnetic reference frame <NUM>. In particular, <FIG> is a block diagram illustrating a system <NUM> utilized to register the optical sensor <NUM> according to some embodiments, and <FIG> is a flowchart illustrating steps utilized in the registration process according to some embodiments.

The system <NUM> includes a computer system <NUM> comprising a processor <NUM> and memory <NUM>. Memory <NUM> is configured to store instructions executable by the processor <NUM> to implement registration module <NUM>. Computer system <NUM> is configured to receive feedback from medical device <NUM>, which includes magnetic sensors <NUM>, optical sensor <NUM>, and non-volatile memory <NUM>. In some embodiments, magnetic sensor <NUM> provides feedback that is utilized to determine the position and/or orientation of the medical device <NUM> in response to the medical device <NUM> being placed in a magnetic field. Optical sensor <NUM> likewise generates feedback that is utilized to determine the position, orientation and/or shape of the optical sensor <NUM>. As discussed above with respect to <FIG>, the feedback received from the magnetic sensors <NUM> is provided based on the external magnetic field applied and is expressed with respect to the magnetic reference frame (mX, mY, mZ). The feedback received from the optical sensor <NUM> is provided only with respect to itself and is expressed with respect to an optical reference fame (oX, oY, oZ). Registration module <NUM> implemented by computer system <NUM> collects position and orientation data (mXi, mYi, mZi, mθi) from the magnetic sensor <NUM> and position, orientation, and shape information (oXi, oYi, oZi, oθi) from the optical sensor <NUM>, and utilizes the collected data to determine transformation data from the optical reference frame to the magnetic reference frame.

With reference to <FIG>, the process of registering the optical localization/shape sensor <NUM> within the reference frame utilized by the first localization sensor <NUM> is illustrated. In some embodiments, the position/shape of the optical sensor <NUM> is modified relative to the first localization sensor <NUM> (e.g., magnetic sensors) and feedback from both the sensors are stored as a fiducial pair. A variety of methods of collecting this data is available, although for purposes of this discussion the medical device is held within a fixture that maintains the position of the first localization sensors <NUM> relatively fixed and the position/shape of the optical sensors <NUM> are modified relative to the first localization sensors <NUM>. In other embodiments, the optical sensors <NUM> may be held relatively fixed and the first localization sensors <NUM> may be modified relative to the optical sensors.

At step <NUM> the medical device <NUM> is placed in a fixture (not shown) and the fixture is placed in a magnetic field (assuming the first localization sensor includes magnetic sensors).

At step <NUM>, the portion of the medical device including optical sensors <NUM> (for example, the distal end <NUM> of the catheter <NUM> shown in <FIG>) is placed in a first position relative to the first localization sensors <NUM>. In subsequent steps, the position of the portion of the medical device <NUM> including the optical sensors <NUM> is modified with respect to the first localization sensor <NUM> in order to collect additional data points describing the relationship between the magnetic reference frame and the optical reference frame. This may be accomplished by maintaining the first localization sensor <NUM> approximately stationary while the position of the optical sensors <NUM> is modified. In one embodiment, a force is applied to the portion of the medical device <NUM> housing the one or more optical sensors <NUM> (e.g., the distal end <NUM> of the catheter <NUM> in the example shown in <FIG>) to cause a deflection in this portion of the medical device relative to the first localization sensors. For example, in one embodiment the desired force may be generated by attachment of a weight to the distal end of the medical device. In other embodiments, other means may be utilized for deflecting the desired portion of the medical device <NUM>. It is desirable that the medical device <NUM> be deflected such that optical sensors <NUM> are compressed/strained to aid in referencing the optical reference frame to the first reference frame.

At step <NUM>, feedback received from the first localization sensor <NUM> is utilized to determine the position and/or orientation (mX<NUM>, mY<NUM>, mZ<NUM>, mθ<NUM>) of the first localization sensors <NUM> within the first reference frame (e.g. magnetic reference frame). Additionally at step <NUM>, feedback received from the optical sensors <NUM> is utilized to determine the position, orientation and/or shape (oX<NUM>, oY<NUM>, oZ<NUM>, oθ<NUM>) of the optical sensors <NUM> within the optical reference frame. As described above with respect to <FIG>, in some embodiments a plurality of fiber cores are utilized, wherein force applied to the fiber cores is detected via compression/strain of optical sensors (e.g., fiber Bragg grating) located in each of the plurality of fiber cores. The optical reference frame may be centered along one of the plurality of fiber cores, such as central core <NUM> shown in <FIG>. In other embodiments, the optical reference frame is centered with respect to one of the plurality of fiber cores located on an outer periphery of the optical conduit (e.g., fiber core 400a).

At step <NUM>, the position data (mX<NUM>, mY<NUM>, mZ<NUM>, mθ<NUM>) and optical-based shape/position data (oX<NUM>, oY<NUM>, oZ<NUM>, oθ<NUM>) are stored as a fiducial pair.

At step <NUM> a determination is made whether a sufficient number of fiducial pairs have been collected. In some embodiments, this may include comparing a count of fiducial pairs stored with a threshold to determine if additional fiducial pairs are required. In other embodiments, a set number of positions are required and the process continues until fiducial pairs have been collected from each of the required positions. In some embodiments, a predetermined threshold number of fiduciary pairs (collected at sufficiently different positions) is collected. For example, if the medical device is rotated approximately <NUM> degrees between each measurement, then four fiduciary pairs of data are collected. In other embodiments, the medical device is rotated <NUM> degrees, and eight fiduciary pairs are collected. In other embodiments, fewer or greater number of fiduciary pairs are collected.

If a sufficient number of fiducial pairs have been collected, then the method proceeds to step <NUM> wherein the plurality of fiducial pairs are utilized to calculate a transformation from the optical reference frame to the first reference frame (e.g., magnetic reference frame). If a sufficient number of fiducial pairs have not been collected, then the method proceeds to step <NUM>.

At step <NUM>, the position of the portion of the medical device <NUM> including the optical sensors (e.g., distal end <NUM> in the embodiment shown in <FIG>) is modified relative to the location of the first localization sensors <NUM> (e.g., magnetic sensors). In some embodiments, modification of the position includes rotating the position of the medical device <NUM> by a known amount (e.g., <NUM> degrees), which causes rotation of both the optical sensors <NUM> and the first localization sensor <NUM>. In some embodiments the medical device <NUM> is rotated within the fixture, while in others the entire fixture holding the medical device <NUM> is rotated. A force is once again applied to the portion of the medical device <NUM> including the optical sensors <NUM> to cause a deflection in the optical sensors <NUM> relative to the first localization sensors <NUM>. In some embodiments, the same force applied in the previous position is applied in this position, resulting in a deflection of the medical device <NUM> that is approximately equal in each position. For example, in embodiments in which a weight is attached to the distal end of the medical device <NUM> to provide the desired deflection force, the same weight applied in the first position is applied in the second position. In other embodiments, the force applied may differ, so long as some force is applied to provide at least some deflection of the optical sensors <NUM> relative to the first localization sensor <NUM>. In still other embodiments, the portion of the medical device <NUM> including the optical sensors <NUM> is moved to a new position relative to the first localization sensor <NUM>.

After modifying the position of the medical device at step <NUM>, at step <NUM> feedback received from the first localization sensor <NUM> is utilized to determine a position and/or orientation of the first localization sensor <NUM> (e.g., mX<NUM>, mY<NUM>, mZ<NUM>, mθ<NUM>) and likewise feedback received from the optical sensors <NUM> are utilized to determine a position, orientation and/or shape of the optical sensors <NUM> (e.g., oX<NUM>, oY<NUM>, oZ<NUM>, oθ<NUM>), which are stored as another fiducial pair. The process of modifying the position of the optical sensors relative to the magnetic sensors and measuring the positions of each is continued until a number of fiducial pairs are collected.

At step <NUM> the transformation required to express position, orientation, and/or shape information collected from the optical sensors <NUM> in the first reference frame (e.g., mX, mY, mZ) is determined based on the plurality of fiducial pairs. In some embodiments, in addition to the plurality of fiducial pairs, additional information may be utilized in determining the transformation from the optical reference frame (e.g., oX, oY, oZ) to the first reference frame (e.g., mX, mY, mZ). For example, in some embodiments the distance d (shown in <FIG>) between the magnetic sensors (210a, 210b) and the optical sensors is utilized in the transformation to determine the position of the optical sensor relative to the magnetic reference frame. In this way, position/shape information collected by the optical sensors <NUM> may be expressed in the first reference frame (e.g., magnetic reference frame).

At step <NUM>, the transformation calculated based on the plurality of fiducial pairs is stored to the medical device <NUM>. In some embodiments, the medical device <NUM> includes non-volatile memory <NUM> utilized to store the transformation. During operational use of the medical device <NUM>, the transformation data stored to non-volatile memory <NUM> may be downloaded or otherwise provided to the computer system (e.g., computer system <NUM> shown in <FIG>) to be utilized by the computer system to transform position/shape information provided by the optical sensor <NUM> to the first reference frame (e.g., magnetic reference frame) to allow the position, orientation, and/or shape of the optical sensor to be displayed accurately within the first reference frame.

With reference to <FIG>, a handle assembly <NUM> is illustrated that includes magnetic sensors 810a, 810b according to some embodiments. As described briefly above, in some embodiments the magnetic sensors 810a, 810b may be located within the handle assembly <NUM> utilized to guide the distal end of the catheter (not shown). In this embodiment, the handle assembly <NUM> must be placed within the magnetic field - for example within the magnetic field generated by the magnetic transmitter assembly <NUM> shown in <FIG>. Based on the feedback provided by the magnetic sensors 810a, 810b, the position and/or orientation of the handle <NUM> may be determined within the magnetic field (i.e., within the magnetic reference frame). In other embodiments, rather than magnetic sensors, one or more other types of localization systems may be utilized to determine the position of the handle assembly <NUM>.

Claim 1:
A localization system (<NUM>) comprising:
a medical device (<NUM>) having a proximal end and a distal end, wherein the distal end includes at least a first localization sensor (<NUM>) and an optical sensor (<NUM>), wherein the first localization sensor (<NUM>) and the optical sensor (<NUM>) are rigidly affixed within the distal end of the medical device; and
a computer system (<NUM>) configured for:
receiving feedback from a first localization sensor (<NUM>);
receiving optical feedback from an optical sensor (<NUM>);
calculating a position of the first localization sensor (<NUM>) based on the received feedback, wherein the position is provided with respect to a first magnetic reference frame defined by the first localization sensor (<NUM>);
calculating a shape of the optical sensor (<NUM>) based on the optical feedback from the optical sensor (<NUM>), wherein the shape is provided with respect to a second optical reference frame defined with respect to the optical sensor (<NUM>);
recording first magnetic position data provided by the first localization sensor (<NUM>) and first optical data provided by the optical sensor (<NUM>);
storing the recorded data as a first fiducial pair, wherein the first magnetic position data is provided in the magnetic reference frame and the first optical data is provided in the optical reference frame;
placing the distal end of the medical device (<NUM>) in a second position, wherein the second position causes a deflection of the optical sensor (<NUM>);
recording second magnetic position data provided by the first localization sensor (<NUM>) and second optical data provided by the optical sensor (<NUM>) and storing the recorded data as a second fiducial pair;
calculating a transformation based on the first and second fiducial pairs to transform the optical shape data form the second optical reference frame to the first magnetic reference frame for transforming the shape of the optical sensor (<NUM>) from the second optical reference frame to the first magnetic reference frame; and
displaying the position and shape of the medical device (<NUM>) with respect to the first magnetic reference frame.