Device, system, and method for localizing medical device within body lumen

Abstract

To provide a device, system and method for localizing medical devices within a body lumen in order to identify the location of a target tissue or navigate to the target tissue, or the like.SOLUTION: An embodiment includes localizing medical devices extended from a working channel of a delivery device. The medical devices may include an imaging sensor for mapping a body lumen, or the like. In many embodiments, the delivery device may include one or more sensors including a first sensor to interact with a tracking system to determine the location of the delivery device within a tracking volume and a second sensor to determine the location of the medical device relative to the delivery device. In many such embodiments, a controller can determine the location of the medical device in the tracking volume on the basis of the location of the delivery device in the tracking volume and the location of the medical device with respect to the delivery device.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of localizing medical devices within a body lumen. In particular, the present disclosure relates to devices, systems, and methods for localizing a medical device extended from a working channel of a delivery device. [Background technology]

[0002] Various medical devices are placed within body lumens for diagnostic or therapeutic purposes. For example, endoscopy is a procedure that uses an endoscope to view the interior of the body. Endoscopy procedures typically utilize an elongated member (e.g., an endoscope) to access, inspect, or interact with the interior of hollow organs or cavities of the body for diagnostic or therapeutic purposes. Endoscopes typically have direct visualization capabilities and / or may also have ultrasound capabilities. Such endoscopes have an exterior diameter that allows them to be inserted into larger body lumens (e.g., the gastrointestinal (GI) tract or trachea). For example, a bronchoscope, a type of endoscope, can be used to visualize the inside of airways for diagnostic and therapeutic purposes, down to a certain number of airways with a diameter that can accommodate the bronchoscope's diameter. The bronchoscope is inserted into the airways through the mouth, nose, or tracheotomy. This allows physicians to examine a patient's airways for abnormalities such as foreign bodies, bleeding, tumors, or inflammation. In some cases, biopsies may be performed from inside the lungs. In certain higher-order airways, the diameter of the airway becomes too narrow to accommodate conventional endoscopes, which presents a challenge for improved devices with means to accurately navigate, locate, and biopsy tissue within these smaller airways or other lumens of smallest diameter. Locating a medical device may refer to determining the location of a medical device within a patient's body lumen. Summary of the Invention

[0003] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0004] In one aspect, the present disclosure relates to a system including a medical device, a drive cable, a marker, and a sensor. The medical device may include a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The drive cable may have a longitudinal axis. The drive cable may be disposed within the lumen of the medical device and configured to rotate about the longitudinal axis. The marker may be attached to and rotatable by the drive cable. The sensor may be configured to detect the marker rotating about the longitudinal axis.

[0005] In various embodiments, the marker includes a magnet, the magnetic poles of the magnet being aligned perpendicular to the longitudinal axis. Some embodiments include an imaging sensor attached to the drive cable. In some such embodiments, the imaging sensor is rotatable by the drive cable. Many embodiments include a processor communicatively coupled to the sensor and a memory communicatively coupled to the processor. The memory may include instructions that, when executed by the processor, cause the processor to measure a rotating magnetic field generated by a marker attached to the drive cable with the sensor. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of the marker relative to the sensor based on the measurement of the rotating magnetic field. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of the marker within the tracking volume based on the location of the sensor within the tracking volume and the location of the marker relative to the sensor. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of the marker in five degrees of freedom within the tracking volume. The memory may include instructions that, when executed by the processor, cause the processor to measure a plurality of reference magnetic fields with the sensor. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of the sensor within the tracking volume based on measurements of a plurality of reference magnetic fields. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of the sensor in six degrees of freedom within the tracking volume. Some embodiments include an imaging sensor attached to a drive cable, the imaging sensor being rotatable by the drive cable. In some such embodiments, the memory includes instructions that, when executed by the processor, cause the processor to generate an image using the imaging sensor and add the image to a mapping of the interior of the body based on the location of the markers within the tracking volume. In various embodiments, the image includes a radial image. Many embodiments include a delivery device comprising a proximal end, a distal end, and a working channel extending between the proximal and distal ends.In many such embodiments, the sensor is disposed within the delivery device and the medical device is disposed within the working channel. In some embodiments, the marker includes a magnet, the magnet being radially symmetric about the longitudinal axis of the drive cable. In various embodiments, the sensor is disposed within a tracking base, the tracking base including multiple magnetic field emitters for generating multiple reference magnetic fields. In many embodiments, the sensor includes a six-degrees-of-freedom (DOF) tunneling magnetoresistive (TMR) sensor.

[0006] In another aspect, the present disclosure relates to an apparatus including a delivery device, a first sensor, and a second sensor. The delivery device may include an elongate member having a proximal end, a distal end, and a working channel extending between the proximal and distal ends. The first sensor may be disposed proximate the distal end of the elongate member. The first sensor may be configured to locate a portion of the delivery device in six degrees of freedom. The second sensor may be disposed proximate the working channel. The second sensor may be configured to measure one or more characteristics of a medical device disposed within the working channel of the delivery device to determine the position of the medical device relative to the delivery device.

[0007] In various embodiments, the position of the medical device relative to the delivery device includes one or more of a linear movement and a rotational movement. In some embodiments, the one or more characteristics include one or more markers encoded with the position of the medical device relative to the delivery device. In some such embodiments, the one or more markers include one or more barcodes or one or more quick response (QR) codes. In various such embodiments, the one or more markers include a plurality of markers disposed along a portion of the medical device, each of the plurality of markers indicating one or more of a linear movement and a rotational movement of the medical device. In many embodiments, the one or more characteristics include a change in an outer surface of the medical device. In many such embodiments, a second sensor emits and detects infrared or near-infrared radiation reflected from the outer surface of the medical device to determine the position of the medical device relative to the delivery device. Some embodiments include a processor communicatively coupled to the first and second sensors and a memory communicatively coupled to the processor. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of the medical device based on locating a portion of the delivery device in six degrees of freedom and the position of the medical device relative to the delivery device. The memory may include instructions that, when executed by the processor, cause the processor to measure a plurality of reference magnetic fields using a first sensor and to localize a portion of the delivery device in six degrees of freedom based on the measurements of the plurality of reference magnetic fields.

[0008] In yet another aspect, the present disclosure relates to a computer-implemented method. The computer-implemented method may include measuring a plurality of reference magnetic fields with a sensor. The computer-implemented method may include determining a location of the sensor within a tracking volume based on measurements of the plurality of reference magnetic fields. The computer-implemented method may include measuring a rotating magnetic field with the sensor. The computer-implemented method may include determining a location of a source of the rotating magnetic field relative to the sensor based on measurements of the rotating magnetic field. The computer-implemented method may include determining a location of a source of the rotating magnetic field within the tracking volume based on the location of the sensor within the tracking volume and the location of the source of the rotating magnetic field relative to the sensor.

[0009] In various embodiments, the computer-implemented method may include rotating a drive cable coupled to a magnet to generate a rotating magnetic field. In some embodiments, the computer-implemented method may include generating an image with an imaging sensor and adding the image to a mapping of the interior of the body based on a location of a source of the rotating magnetic field within the tracking volume. In many embodiments, the computer-implemented method may include rotating the drive cable and magnet coupled to the imaging sensor to generate the rotating magnetic field. In many such embodiments, the image includes a radial ultrasound image.

[0010] In yet another aspect, the present disclosure relates to an apparatus comprising a processor and a memory communicatively coupled to the processor. The memory may include instructions that, when executed by the processor, cause the processor to measure a plurality of reference magnetic fields with a sensor. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of the sensor within a tracking volume based on measurements of the plurality of reference magnetic fields. The memory may include instructions that, when executed by the processor, cause the processor to measure a rotating magnetic field with the sensor. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of a source of the rotating magnetic field relative to the sensor based on the measurements of the rotating magnetic field. The memory may include instructions that, when executed by the processor, cause the processor to determine a location of a source of the rotating magnetic field within the tracking volume based on the location of the sensor within the tracking volume and the location of the source of the rotating magnetic field relative to the sensor.

[0011] In various embodiments, the sensor may be located within the delivery device and the source of the rotating magnetic field may be located within a medical device disposed within the working channel of the delivery device, hi some embodiments, the source of the rotating magnetic field includes a rotating permanent magnet. [Brief explanation of the drawings]

[0012] Non-limiting embodiments of the present disclosure will be described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each of the identical or nearly identical components shown is typically represented by a single numeral. It will be understood that the various figures included in this disclosure may omit some components, show portions of some components, and / or present some components as transparent to facilitate illustration and description of components that may otherwise appear hidden. For purposes of clarity, not every component is labeled in every figure, and not every component of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the disclosure. [Figure 1] 1 illustrates various aspects of a medical system according to one or more embodiments disclosed herein. [Figure 2] 1A-1C illustrate various aspects of a tracking system according to one or more embodiments disclosed herein. [Figure 3] 1A-1D illustrate various aspects of a delivery device together with a medical device according to one or more embodiments disclosed herein. [Figure 4] 1A-1C illustrate various aspects of a sensor disposed within a delivery device according to one or more embodiments disclosed herein. [Figure 5] 10A-10C illustrate various aspects of a marker segment according to one or more embodiments disclosed herein. [Figure 6] FIG. 1 illustrates various aspects of a controller for a medical system according to one or more embodiments disclosed herein. [Figure 7] FIG. 1 illustrates an exemplary process flow according to one or more embodiments disclosed herein. [Figure 8] FIG. 1 illustrates an exemplary computing architecture in accordance with one or more embodiments disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present disclosure generally relates to devices, systems, and methods for locating a medical device within a body lumen, such as for identifying the location of or navigating to a target tissue. Some embodiments are particularly directed to locating a medical device extended from a working channel of a delivery device. In some such embodiments, the medical device includes an imaging sensor for mapping a body lumen or directly visualizing an anatomical structure, etc. In many such embodiments, the delivery device may include one or more sensors that interact with a tracking system to determine the location of the delivery device within a tracking volume, including a first sensor for determining the location of the delivery device within the tracking volume and a second sensor for determining the location of the medical device relative to the delivery device. In many such embodiments, a controller may determine the location of the medical device within the tracking volume based on the location of the delivery device within the tracking volume and the location of the medical device relative to the delivery device. In some such embodiments, the first and second sensors may be the same sensor, such as a six-degrees-of-freedom (DOF) tunneling magnetoresistance (TMR) sensor. In other such embodiments, the first and second sensors may be different sensors. For example, the first sensor may be a 5-DOF position sensor, and the second sensor may be an optical or piezoelectric sensor for reading multiple markers on the medical device. In such cases, the multiple markers may include an indication of the location of the medical device relative to the delivery device. These and other embodiments are described and claimed.

[0014] Medical systems for locating medical devices within body lumens face many challenges, including dimensional constraints for accessing and / or locating peripheral body lumens where suspicious nodules are commonly located. For example, delivery devices such as endobronchial ultrasound (EBUS) scopes are too large (e.g., an outside diameter greater than 4 mm) to reach the peripheral portions of body lumens (e.g., peripheral airways). Furthermore, medical devices inserted through the working channel of a delivery device are subject to dimensional constraints (e.g., an outside diameter less than 2 mm) that prevent the incorporation of various types and / or combinations of components and sensors. For example, some medical devices have a lumen for a biopsy needle. For example, a 6-DOF sensor and a radial imaging sensor cannot be incorporated into a medical device having a lumen for a biopsy needle without exceeding the size constraints of the working channel of the delivery device. Additionally, excluding an imaging sensor prevents real-time visualization, thereby limiting the accuracy and yield of biopsies. The elimination of a 6-DOF sensor hampers the localization of medical devices. Further complicating matters, accurate mapping techniques for body lumens may require real-time imaging and real-time localization to correlate preoperative images with specific locations within the body lumen. Such limitations significantly reduce the usefulness and applicability of medical devices and contribute to the creation of inefficient devices with limited capabilities. Taking these considerations into account, the devices, systems, and methods of the present disclosure may achieve a variety of advantageous medical outcomes.

[0015] Many embodiments herein may include a medical device including an imaging sensor, a lumen for delivering a biopsy needle, and one or more markers configured to indicate a location of the distal end of the medical device relative to the delivery device. Some embodiments include a controller for determining a location of the medical device within the tracking volume based on a location of the medical device relative to the delivery device and a location of the delivery device within the tracking volume.

[0016] In some embodiments, an operator may insert a medical device through a working channel of a delivery device to access a target site within a peripheral body lumen. The operator may then utilize an imaging sensor within the medical device to accurately perform a biopsy of the target site via a needle disposed within the lumen of the medical device. Additionally, a controller communicatively coupled to the medical device and / or delivery device may utilize one or more markers on the medical device to locate the target site relative to the delivery device. In various embodiments, images from the imaging sensor, along with locations determined from the markers, may be used to map the target site and surrounding area, such as to build a three-dimensional model.

[0017] Once a biopsy sample is obtained, it can be removed and analyzed to confirm the need for treatment at the target site. If the need for treatment at the target site is confirmed, a treatment tool can be inserted through the working channel of the delivery device (after removal of the medical device). The location of the target site as previously determined using the medical device can be utilized to accurately and reliably navigate the treatment tool back to the target site. For example, the treatment tool can include a 5-DOF sensor, which can be used in conjunction with the location of the target site determined by the medical device to properly position the treatment tool at the target site. In other examples, a sensor with 6 DOF can be used. In various embodiments, the treatment tool can include one or more treatment devices, such as a drug delivery tool, an implant delivery tool, an ablation probe, a cryogenic probe, a microwave probe, a radio frequency (RF) probe, a laser, an irreversible electroporation (IRE) probe, and a chemical delivery tool.

[0018] One or more techniques described herein may enable accurate localization of a medical device extending from a working channel of a delivery device, resulting in useful and advanced functions such as accurately and reliably locating a target site and / or mapping a peripheral body lumen. In these and other aspects, the components / techniques described herein may identify ways to increase efficiency, reduce performance costs, reduce computational costs, and / or reduce resource requirements for locating and / or mapping portions of a peripheral body lumen in an accurate, responsive, efficient, dynamic, and scalable manner, resulting in several technical effects and advantages over conventional computer technologies, including increased capacity and improved adaptability. In various embodiments, one or more of the aspects, techniques, and / or components described herein may be implemented in actual applications via one or more computing devices, thereby providing additional useful functionality to the one or more computing devices and resulting in more capable, better-performing, and improved computing devices. Additionally, one or more of the embodiments, techniques, and / or components described herein may be utilized to improve the art of obtaining biopsy samples, locating target sites within peripheral body lumens, mapping peripheral body lumens, and locating medical devices within peripheral body lumens.

[0019] In some embodiments, the components described herein may provide specific aspects of efficiently and effectively locating a medical device within a tracking volume based on the relative position of a delivery device to a medical device within the same tracking volume. In some such embodiments, specific aspects may include one or more of determining a location of the delivery device within the tracking volume, determining a location of the medical device relative to the delivery device, and determining a location of the medical device within the same tracking volume. In many embodiments, one or more of the components described herein may be implemented as a set of rules that improve computer-related technology by enabling functionality not previously executable by a computer, allowing improved technical results to be achieved. For example, the enabled functionality may include one or more of determining a location of the delivery device within the tracking volume using a sensor, determining a location of the medical device relative to the delivery device using a sensor, and determining a location of the medical device within the tracking volume based on the location of the medical device relative to the delivery device and the location of the delivery device within the tracking volume. In some embodiments, specific aspects and / or enabled functionality may include determining a location of the delivery device within the tracking volume and determining a location of the medical device relative to the delivery device by performing magnetic field measurements using a sensor.

[0020]

[0013] Making general reference to the notation and nomenclature used herein, one or more portions of the detailed descriptions which follow may be presented in terms of program procedures executed on a computer or network of computers. These procedural descriptions and representations are used by those skilled in the art to effectively convey the substance of their work to others skilled in the art. A procedure is here, and generally, conceived to be a self-consistent sequence of operations leading to a desired result. These operations are those requiring physical manipulations of physical quantities. In some embodiments, these quantities may take the form of electrical, magnetic, or optical signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It proves convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. It should be noted, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities.

[0021] Further, these operations are often referred to in terms, such as adding or comparing, that are commonly associated with mental operations performed by a human operator. However, no such capability of a human operator is necessary, or often desirable, in any of the operations described herein that form part of one or more embodiments. Rather, these operations are machine operations. Useful machines for performing the operations of the various embodiments include general-purpose digital computers selectively activated or configured by a computer program stored therein written in accordance with the teachings herein, and / or specially constructed apparatuses for the required purposes. Various embodiments also relate to apparatuses or systems for performing these operations. These apparatuses may be specially constructed for the required purposes, or may include a general-purpose computer. The required structure for a variety of these machines will be apparent from the description given.

[0022] The following detailed description should be understood with reference to the drawings illustrating exemplary embodiments. The present disclosure is not limited to the specific embodiments described, as such embodiments may vary. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. Finally, while embodiments of the present disclosure may be described with specific reference to medical devices and systems and procedures for treating the respiratory system, it should be understood that such medical devices and methods may be used to treat tissues in the abdominal cavity, digestive system, urinary tract, reproductive tract, gastrointestinal system, cardiovascular system, circulatory system, and the like.

[0023] As used herein, "proximal end" refers to the end of a device closest to a user (such as a medical professional or clinician or technician or operator or physician, such terms are used interchangeably herein without limitation, and include automated controller systems, etc.) along the device when introducing the device into a patient, and "distal end" refers to the end of a device or object furthest from a user along the device during implantation, placement, or delivery.

[0024] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0025] As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so connected, alone and in any combination and number, unless the context clearly dictates otherwise.

[0026] All numerical values ​​herein are assumed to be modified by the term "about," whether explicitly stated or not. The term "about" in the context of numerical values ​​generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the stated value (e.g., having the same function or result). In many cases, the term "about" can include numbers rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) can be assumed to have their ordinary and customary definition as understood from and consistent with the context of this specification, unless otherwise specified. The recitation of numerical ranges or values ​​by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5), and fractions thereof.

[0027] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such a description does not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic. In addition, if a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary.

[0028] It should be understood that the disclosure contained herein is exemplary and explanatory only, and not limiting. As used herein, the terms “comprise,” “comprising,” or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements, but may also include other elements not expressly listed or elements inherent to such process, method, article, or apparatus. The term “exemplary” is used to mean “example” rather than “ideal.” While endoscopes and endoscopic systems are referred to herein, reference to endoscopes, endoscopic systems, or endoscopy should not be construed as limiting the possible applications of the disclosed embodiments. For example, the disclosed embodiments may be used in combination with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices or systems.

[0029] Reference is now made to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding thereof. It will be apparent, however, that the novel embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form to facilitate description. The intention is to cover all modifications, equivalents, and alternatives within the scope of the claims.

[0030] FIG. 1 illustrates various aspects of a medical system 100 according to one or more embodiments disclosed herein. The medical system 100 may include a delivery device 102 having a proximal end 116 and a distal end 118, a medical device 106, a controller 108, and a tracking base 122. In various embodiments, the tracking base 122 may comprise a field generator, such as a magnetic field generator. In the illustrated embodiment, the delivery device 102 includes one or more sensors 104 and a working channel 110 through which the medical device 106 extends. The medical device 106 includes one or more markers 120, one or more lumens 112, and one or more sensors 114. Additionally, the medical device 106 may include a proximal end 116 and a distal end 118. In various embodiments disclosed herein, the medical system 100 may provide functionality that allows for locating the medical device 106 within a body lumen. In some embodiments, FIG. 1 may include one or more components that are the same as or similar to one or more other components of the present disclosure. Furthermore, one or more components of FIG. 1, or aspects thereof, may be incorporated into other embodiments of the present disclosure or excluded from the described embodiments without departing from the scope of the present disclosure. For example, an embodiment of the medical system 100 may be directed to instructions stored on a computer-readable medium included in the controller 108 without departing from the scope of the present disclosure. In another example, an embodiment of the medical system 100 may exclude one or more of the delivery device 102, the medical device 106, the controller 108, and the tracking base 122. In yet another example, an embodiment of the medical device 106 may exclude the lumen 112 or the sensor 114 without departing from the scope of the present disclosure. Furthermore, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components of FIG. 1 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0031] Generally, the delivery device 102 may include one or more sensors 104 and a working channel 110. In some embodiments, the delivery device 102 is a bronchoscope. In various embodiments, one or more of the sensors 104 may be operated in conjunction with the tracking base 122 to determine the location of the delivery device 102, and one or more of the sensors 104 may be operated in conjunction with the markers 120 to determine the location of the medical device 106 relative to the delivery device 102. Thus, the medical system 100 may provide functionality that enables locating the medical device 106 within a body lumen.

[0032] In many embodiments, the medical device 106 includes a lumen for delivering a biopsy needle, an imaging sensor, and one or more markers configured to indicate the location of the distal end of the medical device relative to the delivery device 102. In many such embodiments, the delivery device 102 includes a sensor configured to read, detect, and / or measure the one or more markers 120. Some embodiments include a controller 108 for determining the location of the medical device 106 within the tracking volume based on the location of the medical device 106 relative to the delivery device 102 and the location of the delivery device 102 within the tracking volume. In some such embodiments, the tracking volume may be generated by a tracking base 122.

[0033] In some embodiments, an operator may insert a medical device 106 through the working channel 110 of the delivery device 102 to access a target site within a peripheral body lumen. The operator may then utilize an imaging sensor within the medical device to precisely biopsy the target site (e.g., by providing location / position guidance). Additionally, a controller 108 communicatively coupled to the medical device 106 and / or the delivery device 102 may utilize one or more markers 120 on the medical device to locate the target site. In various embodiments, images from the imaging sensor, along with locations determined from the markers, may be used to map the target site and surrounding areas, such as to build a three-dimensional model of the body lumen. In some embodiments, the imaging sensor may include a radial ultrasound transducer.

[0034] Once the biopsy sample is obtained, it may be removed and analyzed to confirm the need for treatment at the target site. In some embodiments, the tissue sample(s) are collected and sent to a pathology laboratory for diagnosis. In various embodiments, a rapid on-site evaluation (ROSE) may be performed, such as with a pathologist present to analyze the tissue sample and determine a diagnosis. In various such embodiments, real-time confirmation may allow the biopsy needle to be replaced with a therapeutic probe that can be used to treat the target site.

[0035] If the need for treatment at the target site is confirmed, a therapeutic tool such as an ablation probe can be inserted through the working channel of the delivery device (after removal of the medical device). The location of the target site as determined using the medical device can be utilized to accurately and reliably navigate the therapeutic tool back to the target site. For example, the therapeutic tool may include a 6-DOF sensor, such as a 6-DOF TMR sensor, which can be used in conjunction with the location of the target site determined by the medical device to properly position the therapeutic tool at the target site. The therapeutic probe may include or utilize one or more of radio frequency (RF) waves, microwaves, cryogenics, fluids, irreversible electroporation (IRE), or other ablation modalities. In some embodiments, the therapeutic probe may be used to deliver a therapeutic agent, such as chemotherapy spheres, to the target site.

[0036] In various embodiments, medical system 100 may enable reliable and accurate access to a distal portion of a body lumen, such as a small airway. As previously described, access to a distal portion of a body lumen may be utilized to perform a biopsy of a target tissue (e.g., a suspected cancerous nodule) and / or to administer a therapy or treatment to the target tissue. Accordingly, medical device 106 may have a sufficiently small profile to fit into a distal portion of a body lumen while still enabling one or more of real-time localization of medical device 106 (e.g., via one or more of sensors 114), real-time imaging within the distal portion of the body lumen (e.g., via one or more of sensors 114), and delivery of an instrument to a target site, such as via one of lumens 112, without interfering with the real-time localization or real-time imaging. In some embodiments, the outer diameter (OD) of delivery device 102 may not exceed 5 mm. In other embodiments, the OD of delivery device 102 may not exceed 4 mm. In some embodiments, the OD of medical device 106 may not exceed 2 mm. In other embodiments, the OD of the medical device 106 may not exceed 1.8 mm.

[0037] In some embodiments, the medical device 106 may include a taper near its distal end to facilitate navigation and / or entry into small-diameter body lumens, such as small airways. One or more devices or embodiments herein may be sized and / or configured to be utilized for diagnostic or therapeutic purposes, such as one or more of pulmonary, cardiac, endoscopic, and urological applications. In various embodiments, the elongate member profile may be isodiametric with atraumatic (e.g., rounded) edges. Embodiments of the medical system 100 may be utilized in a variety of applications, such as peripheral lung navigation, peripheral lung biopsy, peripheral lung ultrasound reconstruction, and peripheral lung treatment.

[0038] In some embodiments, sensors 104 may generally refer to devices that convert energy from one form to another. In many embodiments, each of the transducers may operate to convert one or more electrical signals into one or more physical quantities (e.g., energy, force, torque, light, motion, position, etc.) and / or convert one or more physical quantities into one or more electrical signals. For example, the transducers may include one or more of an imaging sensor, a phased array sensor, a position sensor, a light emitting diode, a pressure sensor, a magnetic field sensor, a fiber optic sensor, a piezoelectric sensor, a force sensor, etc. In many embodiments, the magnetic field sensors may include sensors such as inductive sensing coils and / or various sensing elements such as magnetoresistive (MR) sensing elements (e.g., anisotropic magnetoresistive (AMR) sensing elements, giant magnetoresistive (GMR) sensing elements, tunneling magnetoresistive (TMR) sensing elements, Hall effect sensing elements, colossal magnetoresistive (CMR) sensing elements, extraordinary magnetoresistive (EMR) sensing elements, spin Hall sensing elements, etc.), giant magneto-impedance (GMI) sensing elements, and / or fluxgate sensing elements. Many of the sensors described herein may determine one or more of the position / location up to 6 DOF (i.e., x, y, z measurements, and one or more of pitch, yaw, and roll angles).

[0039] FIG. 2 illustrates various aspects of a tracking system 202 according to one or more embodiments disclosed herein. The illustrated embodiment includes a tracking base 204, a delivery device 214, and a medical device 216. The tracking base 204 includes multiple field emitters 206 and multiple reference sensors 208, and the delivery device 214 may include a magnetic field sensor 212. The tracking system 202 may be utilized to locate the magnetic field sensor 212 within a tracking volume 210. In some embodiments, FIG. 2 may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, the tracking base 204 may be the same as or similar to the tracking base 122. Furthermore, one or more components of FIG. 2, or aspects thereof, may be incorporated into other embodiments of the present disclosure or excluded from the described embodiments without departing from the scope of the present disclosure. For example, the magnetic field sensor 212 may be incorporated into the delivery device 102 without departing from the scope of the present disclosure. Additionally, one or more components, or aspects thereof, of other embodiments of the present disclosure may be incorporated into one or more components of Figure 2 without departing from the scope of the present disclosure. For example, medical device 106 having marker 120 may be incorporated into medical device 216 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0040] Generally, the tracking system 202 may operate to determine the location of the magnetic field sensor 212 by measuring a plurality of magnetic fields generated by each of a plurality of field emitters 206 in the tracking base 204 using the magnetic field sensor 212. In one or more embodiments described herein, the location (e.g., distal end) of the medical device 216 can be determined based at least in part on the location of the magnetic field sensor 212 within the tracking volume 210. In many embodiments, a patient may be positioned within the tracking volume 210. In some embodiments, one or more pre-operative scans of the patient may be registered (also referred to as registration) with the tracking volume 210. In various embodiments, the pre-operative scans may include or utilize magnetic resonance imaging (MRI) and / or computed tomography (CT).

[0041] For example, the multiple field emitters 206 in the tracking base 204 may generate multiple reference magnetic fields in the tracking volume 210 that can be measured by the magnetic field sensors 212. In many embodiments, five or more reference magnetic fields can be measured by the sensors. For example, the tracking base 204 may generate 12 reference magnetic fields by the multiple field emitters 206 that are measured by the magnetic field sensors 212. In many embodiments, the controller 608 may calculate vectors from the magnetic field sensors 212 to each of the multiple field emitters 206 in the tracking base 204. In some embodiments, the controller 608 may use the multiple vectors combined with the known geometric relationships between each of the multiple field emitters 206 to determine the location of the magnetic field sensors 212 within the tracking volume 210. In some embodiments, measurements by the multiple reference sensors 208 may be utilized along with measurements by the magnetic field sensors 212 to determine the location of the magnetic field sensors 212 within the tracking volume 210. In various embodiments, the multiple reference sensors 208 may be used to calibrate the multiple field emitters 206 and / or the tracking volume 210. In some embodiments, multiple reference sensors 208 may be utilized in determining the location of the medical device 216. For example, multiple reference sensors 208 may be used to measure the rotating magnetic field generated by the medical device 216.

[0042] In many embodiments, the magnetic field sensor 212 may comprise a five-degree-of-freedom (DOF) or six-degree-of-freedom (DOF) sensor. In various embodiments, the magnetic field sensor 212 may be cylindrical with a length of less than 9 mm and a diameter of less than 1.5 mm. In one embodiment, the magnetic field sensor 212 may include a cylindrical TMR sensor with a length of 8 mm and a diameter of 0.65 mm. In some embodiments, the magnetic field sensor 212 may include or be mounted on a semicircular or "C" shaped flexible circuit board and / or sensor. In various embodiments, the magnetic field sensor 212 may be embedded in or mounted on either the inside or outside of the delivery device 214.

[0043] FIG. 3 illustrates various aspects of a delivery device 302 along with a medical device 304 according to one or more embodiments disclosed herein. The illustrated embodiment includes a distal end 314 of the delivery device 302 and the medical device 304. The delivery device 302 includes an electromagnetic sensor 312. The medical device 106 includes a sheath 316 having an imaging sensor 306 and a marker 308 coupled to a drive cable 310 disposed within the sheath 316. Embodiments disclosed herein may include multiple markers of various shapes, forms, and materials. In the illustrated embodiment, the marker 308 comprises a magnet attached to and rotatable by the drive cable 310. In some embodiments, the location of the marker 308 can be determined by measuring a rotating magnetic field generated by the marker 308 as it is rotated by the drive cable 310. In many embodiments, the location of the marker 308 relative to the electromagnetic sensor 312 can be determined based on measurements of the magnetic field generated by the marker 308. In some embodiments, FIG. 3 may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, delivery device 302 may be the same as or similar to delivery device 102. Furthermore, one or more components of FIG. 3, or aspects thereof, may be incorporated into other embodiments of the present disclosure or excluded from the described embodiments without departing from the scope of the present disclosure. For example, medical device 304 may be incorporated into medical device 604 without departing from the scope of the present disclosure. Furthermore, one or more components, or aspects thereof, of other embodiments of the present disclosure may be incorporated into one or more components of FIG. 3 without departing from the scope of the present disclosure. For example, lumen 112 of medical device 304 may be incorporated into medical device 106 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0044] In many embodiments, the marker 308 may comprise a permanent magnet magnetized cross-axially relative to the longitudinal axis of the drive cable 310 (i.e., the magnetic poles are aligned perpendicular to the longitudinal axis). In some embodiments, the marker 308 may be radially symmetric (e.g., cylindrical, spherical, etc.) relative to the longitudinal axis of the drive cable 310. In some embodiments, the marker 308 is a permanent magnet, while in other embodiments, the marker 308 is an electromagnet. In various embodiments, the rotation of the drive cable 310 combined with the cross-axial alignment of the magnetic poles of the marker 308 generates a rotating magnetic field having characteristics that can be measured by a sensor (e.g., electromagnetic sensor 312) to reliably determine the location of the marker 308 relative to the sensor. In some embodiments, the rotating magnetic field may help isolate the marker 308 from background noise (e.g., the Earth's magnetic field).

[0045] In various embodiments, the location of the marker 308 may be determined by analyzing signals from one or more sensors (e.g., electromagnetic sensor 312) in the delivery device 302, static or dynamic reference sensors disposed on the patient (e.g., a sensor patch), and one or more reference sensors in the tracking system (e.g., reference sensor 208 in the tracking base 204). For example, measurements of a rotating magnetic field by one or more of the sensors can be combined with the location of one or more sensors within the tracking volume and utilized to determine the location of the source of the rotating magnetic field (i.e., marker 308), as in a 6-DOF case. In some embodiments, the location of the marker 308 may be determined in 5-DOF. For example, the rotation of the marker 308 about its axis may not be determinable by measuring a magnetic field rotating about the same axis. However, in many embodiments, the rotational position (e.g., the sixth degree of freedom) of the marker 308 may be determined using other techniques. For example, one or more images generated using the imaging sensor 306 may be registered to one or more pre-operative images, such as using 5-DOF positions, to determine the rotational position of the marker 308. In many embodiments, the pre-operative images may include CT and / or MRI images. The rotational frequency of the marker 308 is different from the frequency of the transmit coil (e.g., in the field emitter 206) and provides a distinguishing characteristic.

[0046] In some embodiments, the medical device 304 comprises a radial imaging device that utilizes the drive cable 310 to rotate the imaging sensor 306 to generate a radial image. In some such embodiments, the imaging sensor 306 comprises an ultrasound transducer. In various embodiments, the radial image may be generated by combining multiple two-dimensional planar images captured by the imaging sensor 306 during rotation. In some embodiments, an image processor (e.g., included in the controller 108) may operate to generate the radial image from the multiple two-dimensional planar images. In many embodiments, the marker 308 is attached to the distal end of the imaging sensor 306. In other embodiments, the marker 308 may be located proximal to the imaging sensor 306. One or more embodiments may include multiple markers 308 positioned along the drive cable 310, such as both proximal and distal to the imaging sensor 306. In various embodiments, data captured by the imaging sensor 306 may be combined with locations determined by the electromagnetic sensor 312 to map or generate a model (e.g., a three-dimensional or four-dimensional model) of the interior portion of the body lumen. In some embodiments, the fourth dimension may refer to three dimensions of space and one dimension of time.

[0047] FIG. 4 illustrates various aspects of a sensor 402 disposed within a delivery device 406 according to one or more embodiments disclosed herein. The illustrated embodiment includes a distal end 410 of a delivery device 406 having a working channel 412 through which a medical device 414 having one or more markers 404 extends. In various embodiments, the sensor 402 can detect characteristics of the markers 404 to determine the location of the medical device 414 relative to the delivery device 406. In some embodiments, FIG. 4 can include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, the medical device 414 can be the same as or similar to the medical device 106. Furthermore, one or more components of FIG. 4, or aspects thereof, may be incorporated into other embodiments of the present disclosure or excluded from the described embodiments without departing from the scope of the present disclosure. For example, the sensor 402 can be incorporated into the delivery device 214 without departing from the scope of the present disclosure. Additionally, one or more components, or aspects thereof, of other embodiments of the present disclosure may be incorporated into one or more components of Figure 4 without departing from the scope of the present disclosure. For example, magnetic field sensor 212 may be incorporated into delivery device 406 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0048] In some embodiments, the sensor 402 is added to the working channel 412 of the delivery device 406, such as by being embedded in the wall of the working channel 412. In some such embodiments, the sensor 402 may be utilized to measure one or more of the linear and rotational movement of the device passing through the working channel 412. In some embodiments, the sensor 402 may detect multiple markers 404 on the medical device 414 to determine the location of the medical device 414 relative to the delivery device 406. In some embodiments, the sensor 402 may utilize changes in the outer surface of the device (e.g., the medical device 414) passing through the working channel 412 to determine the linear and / or rotational movement. For example, the sensor 402 may emit and detect infrared or near-infrared light reflecting off the medical device 414 passing through the working channel 412 to determine the linear and / or rotational movement based on surface features. In various embodiments, the sensor 402 may include any type of sensor that can be utilized to locate the medical device 414, such as one or more of a magnetic sensor, a piezoelectric sensor, an imaging transducer, an optical mouse sensor, and an induction coil. In one embodiment, the sensor 402 may include a magnetoresistive sensor. More generally, the type of sensor 402 may correspond to the type, inclusion, and / or location of the marker.

[0049] The sensor 402 can be positioned along the length of the working channel 412, such as in the distal tip, along the shaft, or in the handle. In many embodiments, the sensor 402 can be positioned proximate the distal end 410 of the working channel 412 to limit linear and / or rotational errors. For example, linear errors can occur due to race tracking or the like, which results in linear movement errors at the distal end when the working channel 412 is not ideally positioned relative to the central / neutral axis of the delivery device 406. In another example, rotational errors can occur when the delivery device 406 is an imperfect torque transmitter, which can cause differential rotation between the distal and proximal ends of the delivery device 406 when torque is applied.

[0050] In some embodiments, sensor 402 may monitor a medical device through the wall of working channel 412. Accordingly, in some embodiments, a viewing window may be incorporated to allow sensor 402 to monitor the device through the wall. For example, a viewing window may be utilized to replace a portion of the braided layer surrounding working channel 412. In another example, a lighter or looser braid may be utilized in proximity to sensor 402. The location of sensor 402 may be determined at least in part based on the type, inclusion, and / or location of the marker.

[0051] FIG. 5 illustrates various aspects of a marker segment 502 according to one or more embodiments disclosed herein. In the illustrated embodiment, the marker segment 502 has a proximal end 508, a distal end 510, and includes markers 504a, 504b, 504c, 504d, 506a, 506b, 506c, and 506d (or markers 318, 320). The embodiments disclosed herein may include multiple markers of various shapes, forms, and materials. In many embodiments, one or more marker segments 502 may be positioned along (e.g., external to or embedded in) the medical device 414. In some embodiments, one or more of the markers 318, 320 may be detected by a sensor to determine the location of the medical device relative to the delivery device. In some embodiments, FIG. 5 may include one or more components that are the same as or similar to one or more other components of the present disclosure. Furthermore, one or more components, or aspects thereof, of FIG. 5 may be incorporated into other embodiments of the present disclosure or excluded from the described embodiments without departing from the scope of the present disclosure. For example, marker segment 502 may be incorporated into multiple markers 404 without departing from the scope of the present disclosure. Furthermore, one or more components, or aspects thereof, of other embodiments of the present disclosure may be incorporated into one or more components of FIG. 5 without departing from the scope of the present disclosure. For example, medical device 216 may be incorporated into marker segment 502 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0052] In many embodiments, markings may be placed on the shaft of medical device 414 at known locations relative to the distal tip of delivery device 406. In some embodiments, each marker includes an indicator, such as a coding pattern, that provides information about the position of the medical device relative to the delivery device. In some embodiments, each one of the multiple markers in marker segment 502 may identify a unique linear and / or rotational displacement. For example, marker 504a may correspond to 10 mm of linear displacement and 15 degrees of rotational displacement, marker 504b may correspond to 10 mm of linear displacement and 10 degrees of rotational displacement, and marker 506a may correspond to 5 mm of linear displacement and 15 degrees of rotational displacement.

[0053] The location, type, and / or arrangement of the plurality of markers within marker segment 502 may be determined based at least in part on the type, inclusion, and / or location of a sensor (e.g., sensor 402) for detecting the markers. In various embodiments, the plurality of markers may include one or more of magnetic markings (e.g., readable by a magnetic sensor), textured markings (e.g., readable by a piezoelectric sensor), markings that are visible only when illuminated with a certain wavelength of light (e.g., infrared or ultraviolet). In one embodiment, the markings may be visible lines or patterns (e.g., barcodes or quick response (QR) codes) that may be detected by an optical or imaging sensor.

[0054] In one or more embodiments, the multiple markers may include magnetic markings (e.g., patterns of magnetic material). For example, magnetic markings consisting of a pattern of lines may be included using a ferromagnetically doped polymer. In such an example, each marker in marker segment 502 may include a magnetic marking encoded with a unique linear and / or rotational position of the medical device (e.g., medical device 414). In various embodiments, the medical device may have separate rotational and linear position markers. In many embodiments, the medical device may include multiple marker segments 502.

[0055] In many embodiments, the magnetic markings may be read by a magnetoresistive sensor. In various embodiments, the magnetic markings are read by an induction coil disposed around the working channel of the delivery device. In some embodiments, the markers may include one or more permanent magnets embedded in or affixed to the medical device. In some such embodiments, one or more magnetic sensors (such as those in the delivery device) may be utilized to estimate the position and / or distance of the medical device based on one or more static magnetic fields of the one or more permanent magnets. In some embodiments, a pattern or arrangement of permanent magnets may be utilized to generate a static magnetic field with uniquely mappable characteristics.

[0056] FIG. 6 illustrates various aspects of a controller 608 for a medical system 600 according to one or more embodiments disclosed herein. In the illustrated embodiment, the medical system 600 includes a delivery device 602, a medical device 604, a tracking base 606, and a controller 608. The controller 608 includes logic circuitry 610, memory 612, input / output (I / O) 614, and a user interface 616. In many embodiments, the controller 608 may operate to locate one or more of the delivery device 602 and the medical device 604 and / or map the interior of the body. In some embodiments, FIG. 6 may include one or more components that are the same as or similar to one or more other components of the present disclosure. For example, the medical device 604 may be the same as or similar to the medical device 304. Furthermore, one or more components of FIG. 6, or aspects thereof, may be incorporated into other embodiments of the present disclosure or excluded from the described embodiments without departing from the scope of the present disclosure. For example, the tracking base 606 may be excluded from the medical system 600 without departing from the scope of the present disclosure. In another example, the user interface 616 may be excluded from the controller 608 without departing from the scope of the present disclosure. Furthermore, one or more components, or aspects thereof, of other embodiments of the present disclosure may be incorporated into one or more components of FIG. 6 without departing from the scope of the present disclosure. For example, the electromagnetic sensor 312 may be incorporated into the delivery device 602 without departing from the scope of the present disclosure. The embodiments are not limited in this context.

[0057] In various embodiments, the controller 608 may perform one or more functions disclosed herein. For example, instructions stored in the memory 612 may be executed by the logic 610 to operate sensors within the delivery device 602 to determine the location of the medical device 604. In some embodiments, the logic 610 may send and receive signals from one or more components of the delivery device 602, the medical device 604, and the tracking base 606 via the I / O 614. For example, the logic 610 may determine the location of the medical device 604 by utilizing sensors within the delivery device 602. In many embodiments, the logic 610 may generate metadata regarding signals received from the transducers. In many such embodiments, the metadata may correspond to signals from one or more other transducers within the delivery device 602. For example, the location of the delivery device 602 indicated by a magnetic tracking sensor may be associated with an image from an imaging sensor as metadata.

[0058] In many embodiments, the controller 608 may track the translation and / or rotation of the medical device 604 relative to the delivery device 602. In many such embodiments, the controller 608 may generate a transform that can be utilized to determine the location of the medical device 604 relative to the delivery device 602. In some embodiments, the location data may be utilized by the controller 608 or the like for one or more of targeting, device visualization, augmented reality, mapping, and modeling. In some embodiments, three-dimensional and four-dimensional ultrasound reconstructions may be performed using ultrasound transducers integrated into the medical device, such as radial ultrasound transducers. Various embodiments enable accurate intraoperative 3D imaging of the lesion in the coordinate space of the tracking system (e.g., the tracking volume 210) to enable a therapy delivery tool being tracked (by the tracking system) to be positioned at the correct location for optimal therapy delivery.

[0059] In some embodiments, the logic circuitry 610 may perform image processing. For example, multiple images generated by an imaging sensor (e.g., imaging sensor 306) may be stitched together to create a composite image of the interior of the body. In some embodiments, the logic circuitry 610 may perform mapping, such as by utilizing data from multiple transducers to generate a composite image. For example, positional data (e.g., in 6-DOF) may be combined with the images to generate a composite image. In some embodiments, metadata associated with the images may indicate the position of the imaging sensor (e.g., in 6-DOF) when the imaging sensor captured the image. In various embodiments, multiple images may be combined to generate a radial image. In various such embodiments, multiple radial images may be combined to generate a composite image of an interior portion of the body.

[0060] In one or more embodiments, data from the pre-operative scan may be stored in memory 612 and / or utilized by logic circuit 610. In some embodiments, logic circuit 602 may utilize the pre-operative data along with surgical data (e.g., sensor data received from one or more of delivery device 602, medical device 604, and tracking base 606) to determine the positions of delivery device 602 and medical device 604. For example, logic circuit 610 may match landmarks identified in the pre-operative image with elements in an image generated via delivery device 602 to determine the position of delivery device 602. In another example, the pre-operative image may be overlaid with the patient's position within a tracking volume (e.g., see tracking volume 210) of tracking base 606.

[0061] In some embodiments, the logic circuit 602 may perform motion compensation. For example, the logic circuit 602 may compensate for respiratory motion. In various embodiments, motion compensation may enable surgical data to be matched with pre-operative data (e.g., from a computed tomography (CT) scan). For example, motion compensation may enable surgical images to be overlaid on pre-operative images with reliable accuracy.

[0062] In various embodiments, the logic circuit 602 may perform one or more of object detection, distance estimation, and object classification. In various such embodiments, the logic circuit 602 may identify a mass from multiple ultrasound images, determine a distance to the mass based on the multiple ultrasound images, and classify the mass based on the size, location, and distance of the mass. In some embodiments, the logic circuit 602 may utilize data from a preoperative scan to classify the mass, such as by matching the mass to landmarks identified in the preoperative images. For example, a target nodule for biopsy located in a peripheral portion of the lung may be confirmed by comparing an object detected in an ultrasound image with one or more preoperative images containing the target nodule. In many embodiments, object detection and classification may be used for boundary detection, such as to identify airway branches.

[0063] In many embodiments, the logic circuit 602 may generate a three-dimensional model of one or more parts of the interior of the body. In some embodiments, one or more techniques described herein may be utilized to generate the three-dimensional model of transducer data, pre-operative data, synthetic images, metadata, images, positions, objects, distances, object classifications, etc. In various embodiments, the three-dimensional model may include the positions of the delivery device 602 and the medical device 604.

[0064] In various embodiments, an operator may cause logic 610 to perform various functions by providing input via user interface 616. In some embodiments, image generation may be controlled via user interface 616. In one or more embodiments, object classification may be controlled via user interface 616. For example, a user may add or remove classifications by selecting objects in an image presented via user interface 616. In some embodiments, logic may determine the distance between two points identified in an image presented via user interface 616. For example, logic 602 may determine the distance between two objects selected by the user in an image. In many embodiments, output may be presented to the operator via user interface 616. For example, a three-dimensional model of an interior portion of a body may be presented via user interface 616.

[0065] In many embodiments, additional and / or updated functionality may be incorporated into controller 608, such as by storing additional and / or updated instructions (e.g., as software) on memory 612. In one or more embodiments, controller 608 may be connected to a network (e.g., the Internet, a local area network, a personal area network, or an inductive coupling). In one or more such embodiments, controller 608 may be updated and / or provided with additional functionality by receiving instructions over the network.

[0066] 7 illustrates a process flow 700 according to one or more embodiments disclosed herein. In various embodiments, one or more portions of process flow 700 may be performed by or using components disclosed herein. For example, blocks 702 through 710 may be performed using controller 608 in conjunction with delivery device 302 and medical device 304. The embodiments are not limited in this context.

[0067] In the illustrated embodiment, the process flow 700 may begin at block 702. In block 702, "Measure Multiple Reference Magnetic Fields Using Sensors," multiple reference magnetic fields may be measured using sensors. For example, multiple field emitters 206 in the tracking base 204 may generate multiple reference magnetic fields in the tracking volume 210 that may be measured by the magnetic field sensors 212. In many embodiments, five or more reference magnetic fields may be measured by the sensors. For example, the tracking base 204 may generate 12 reference magnetic fields using the multiple field emitters 206 that are measured by the magnetic field sensors 212.

[0068] Moving to block 704, "Determine a location of the sensor within the tracking volume based on measurements of the plurality of reference magnetic fields," the location of the sensor within the tracking volume may be determined based on measurements of the plurality of reference magnetic fields. For example, the controller 608 may calculate a vector from the magnetic field sensor 212 to each of the plurality of field emitters 206 in the tracking base 204. In some embodiments, the controller 608 may use the plurality of vectors combined with known geometric relationships between each of the plurality of field emitters 206 to determine the location of the magnetic field sensor 212 within the tracking volume 210. Moving to block 706, "Measure a rotating magnetic field using a sensor," the rotating magnetic field may be measured using a sensor. For example, the electromagnetic sensor 312 may be used to measure the rotating magnetic field generated by the marker 308 rotating about the longitudinal axis of the drive cable 310. In many embodiments, the marker 308 may comprise a magnet with magnetic poles aligned perpendicular to the longitudinal axis of the drive cable 310.

[0069] At block 708 "Determine location of source of rotating magnetic field relative to sensor based on measurement of rotating magnetic field," the location of the source of the rotating magnetic field relative to the sensor can be determined based on the measurement of the rotating magnetic field. For example, the location of the marker 308 (i.e., the source of the rotating magnetic field) can be determined relative to the electromagnetic sensor 312 based on the measurement of the rotating magnetic field. Thus, the location of the portion of the delivery device 302 relative to the portion of the medical device 304 can be reliably and accurately determined.

[0070] Moving to block 710, "Determine location of source of rotating magnetic field in tracking volume based on location of sensor in tracking volume and location of source of rotating magnetic field relative to sensor," the location of the source of the rotating magnetic field in the tracking volume may be determined based on the location of the sensor in the tracking volume and the location of the source of the rotating magnetic field relative to the sensor. For example, controller 608 may determine the location of the distal end of medical device 604 within the tracking volume of tracking base 606 based on the location of the distal end of delivery device 602 within the tracking volume and the location of the distal end of medical device 604 relative to the distal end of delivery device 602.

[0071] 8 illustrates a computing architecture 800 according to one or more embodiments disclosed herein. The computing architecture 800 may be suitable for implementing various embodiments such as those described above. In various embodiments, the computing architecture 800 may include or be implemented as part of an electronic device and / or a medical device. In some embodiments, the computing architecture 800 may represent, for example, one or more components described herein. In some embodiments, the computing architecture 800 may represent a computing device that implements or utilizes one or more portions of the components and / or techniques described herein, such as, for example, the controller 108, the sensor 104, the controller 608, the logic circuit 610, the memory 612, the I / O 614, and / or the user interface 616. The embodiments are not limited in this context.

[0072] As used in various embodiments herein, the terms “system,” “component,” and “module” can refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution, an example of which is provided by exemplary computing architecture 800. For example, a component may be, but is not limited to, a process running on a processor, a processor, a hard disk drive, multiple storage drives (optical and / or magnetic storage media), an object, an executable file, a thread of execution, a program, and / or a computer. By way of example, both an application running on controller 108 and the controller 108 may be a component. One or more components may reside within a process and / or thread of execution, and components may be localized on one computer and / or distributed among two or more computers. Furthermore, components may be communicatively coupled to each other by various types of communication media to coordinate operations. Coordination may include unidirectional or bidirectional exchange of information. For example, components may communicate information in the form of signals communicated over communication media. Information may be embodied as signals assigned to various signal lines. In such assignments, each message is a signal. However, further embodiments may alternatively employ data messages. Such data messages may be transmitted over a variety of connections. Exemplary connections include parallel interfaces, serial interfaces, and bus interfaces.

[0073] Computing architecture 800 may include various common computing elements, such as one or more processors, multi-core processors, co-processors, memory units, chipsets, controllers, peripherals, interfaces, oscillators, timing devices, video cards, audio cards, multimedia input / output (I / O) components, power supplies, etc. However, embodiments are not limited to implementation with computing architecture 800.

[0074] 8, computing architecture 800 includes a processing unit 804, a system memory 806, and a system bus 808. Processing unit 804 can be any of a variety of commercially available processors, including, but not limited to, AMD® Athlon®, Duron®, and Opteron® processors, ARM® application, embedded, and secure processors, IBM® and Motorola® DragonBall® and PowerPC® processors, IBM and Sony® Cell processors, Intel® Celeron®, Core® Duo®, Itanium®, Pentium®, Xeon®, and XScale® processors, and similar processors. Dual microprocessors, multi-core processors, and other multi-processor architectures can also be employed as processing unit 804.

[0075] The system bus 808 provides an interface to the processing unit 804 for system components, including but not limited to, the system memory 806. The system bus 808 can be any of several types of bus structures that can be further interconnected to a memory bus (with or without a memory controller), a peripheral bus, and a local bus using any of a variety of commercially available bus architectures. Interface adapters can be connected to the system bus 808 via a slot architecture. Exemplary slot architectures can include, but are not limited to, Accelerated Graphics Port (AGP), CardBus, (Extended) Industry Standard Architecture ((E)ISA), MicroChannel Architecture (MCA), NuBus, Peripheral Component Interconnect (Expansion) (PCI(X)), PCI Express, Personal Computer Memory Card International Association (PCMCIA), etc.

[0076] The system memory 806 may include various types of computer-readable storage media in the form of one or more high-speed memory units, such as read-only memory (ROM), random-access memory (RAM), dynamic RAM (DRAM), double-data-rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory (e.g., one or more flash arrays), polymer memory such as ferroelectric polymer memory, ovonic memory, phase-change or ferroelectric memory, silicon-oxide-nitride-oxide-silicon (SONOS) memory, magnetic or optical cards, arrays of devices such as redundant array of independent disks (RAID) drives, solid-state memory devices (e.g., USB memory, solid-state drives (SSDs)), and any other type of storage media suitable for storing information. In the exemplary embodiment shown in FIG. 8, the system memory 806 may include non-volatile memory 810 and / or volatile memory 812. In some embodiments, the system memory 806 may include a main memory. A basic input / output system (BIOS) may be stored in the non-volatile memory 810.

[0077] Computer 802 may include various types of computer-readable storage media in the form of one or more low-speed memory units, including an internal (or external) hard disk drive (HDD) 814, a magnetic floppy disk drive (FDD) 816 for reading from or writing to a removable magnetic disk 818, and an optical disk drive 820 for reading from or writing to a removable optical disk 822 (e.g., a CD-ROM or DVD). HDD 814, FDD 816, and optical disk drive 820 may be connected to system bus 808 by HDD interface 824, FDD interface 826, and optical drive interface 828, respectively. HDD interface 824 for external drive implementations may include at least one or both of Universal Serial Bus (USB) and Institute of Electrical and Electronics Engineers (IEEE) 994 interface technologies. In various embodiments, these types of memory may not be included in main memory or system memory.

[0078] The drives and associated computer-readable media provide volatile and / or nonvolatile storage of data, data structures, computer-executable instructions, etc. A number of program modules can be stored on the drives and memory units 810, 812, including, for example, an operating system 830, one or more application programs 832, other program modules 834, and program data 836. In one embodiment, the one or more application programs 832, other program modules 834, and program data 836 can include or implement, for example, the various techniques, applications, and / or components described herein.

[0079] A user can enter commands and information into computer 802 through one or more wired / wireless input devices, for example, a keyboard 838 and a pointing device such as a mouse 840. Other input devices may include sensors 104, 114, tracking base 122, imaging sensor 306, electromagnetic sensor 312, microphones, infrared (IR) remote controls, radio frequency (RF) remote controls, game pads, stylus pens, card readers, dongles, fingerprint readers, gloves, graphics tablets, joysticks, keyboards, retina readers, touch screens (e.g., capacitive, resistive, etc.), trackballs, track pads, sensors, styluses, etc. These and other input devices are often connected to processing unit 804 through an input device interface 842 coupled to system bus 808, but may also be connected by other interfaces, such as a parallel port, an IEEE 994 serial port, a game port, a USB port, an IR interface, etc.

[0080] A monitor 844 or other type of display device is also connected to the system bus 808 via an interface, such as a video adapter 846. The monitor 844 may be internal or external to the computer 802. In addition to the monitor 844, computers typically include other peripheral output devices, such as speakers, printers, etc.

[0081] The computer 802 can operate in a networked environment using logical connections via wired and / or wireless communications to one or more remote computers, such as a remote computer 848. In various embodiments, one or more interactions described herein may occur via a networked environment. The remote computer 848 may be a workstation, a server computer, a router, a personal computer, a portable computer, a microprocessor-based entertainment appliance, a peer device, or other common network node, and typically includes many or all of the elements described relative to the computer 802, although for purposes of brevity, only a memory / storage device 850 is shown. The logical connections shown include wired / wireless connections to a local area network (LAN) 852 and / or larger networks, e.g., a wide area network (WAN) 854. Such LAN and WAN networking environments are commonplace in offices and companies and facilitate enterprise-wide computer networks, such as intranets, all of which may be connected to a global communications network, e.g., the Internet.

[0082] When used in a LAN networking environment, the computer 802 is connected to the LAN 852 through a wired and / or wireless communication network interface or adapter 856. The adapter 856 can facilitate wired and / or wireless communication to the LAN 852 and can also include a wireless access point disposed therein for communicating with the wireless capabilities of the adapter 856.

[0083] When used in a WAN networking environment, the computer 802 may include a modem 858, or be connected to a communications server on the WAN 854, or have other means for establishing communications over the WAN 854, such as via the Internet. The modem 858, which may be internal or external and may be a wired and / or wireless device, connects to the system bus 808 via the input device interface 842. In a networked environment, program modules depicted relative to the computer 802, or portions thereof, may be stored in the remote memory / storage device 850. It will be appreciated that the network connections shown are exemplary and other means of establishing a communications link between the computers may be used.

[0084] The computer 802 is operable to communicate with wired and wireless devices or entities using the IEEE 802 family of standards, such as wireless devices operatively arranged for wireless communication (e.g., IEEE 802.16 wireless modulation technology). This includes at least Wi-Fi (or Wireless Fidelity), WiMAX, and Bluetooth® wireless technologies, among others. Thus, communication may be in a predefined structure, similar to a traditional network, or simply ad hoc communication between at least two devices. Wi-Fi networks use wireless technologies called IEEE 802.11x (a, b, g, n, etc.) to provide secure, reliable, high-speed wireless connectivity. Wi-Fi networks can be used to connect computers to each other, to the Internet, and to wired networks (which use IEEE 802.3-related media and functions).

[0085] Various embodiments may be implemented using hardware elements, software elements, or a combination of both. Examples of hardware elements may include a processor, a microprocessor, a circuit, a circuit element (e.g., a transistor, a resistor, a capacitor, an inductor, etc.), an integrated circuit, an application specific integrated circuit (ASIC), a programmable logic device (PLD), a digital signal processor (DSP), a field programmable gate array (FPGA), a logic gate, a register, a semiconductor device, a chip, a microchip, a chipset, etc. Examples of software may include a software component, a program, an application, a computer program, an application program, a system program, a machine program, an operating system software, a middleware, a firmware, a software module, a routine, a subroutine, a function, a method, a procedure, a software interface, an application program interface (API), an instruction set, a computing code, a computer code, a code segment, a computer code segment, a word, a value, a symbol, or any combination thereof. The decision of whether an embodiment is implemented using hardware and / or software elements may vary according to any number of factors, such as desired computational speed, power level, thermal tolerance, processing cycle budget, input data rate, output data rate, memory resources, data bus speed, and other design or performance constraints.

[0086] One or more aspects of at least one embodiment may be implemented by representative instructions stored on a machine-readable medium representing various logic within a processor (e.g., logic circuitry), which, when read by a machine, causes the machine to create logic for performing the techniques described herein. Such representations, known as “IP cores,” may be stored on tangible machine-readable media and supplied to various customers or manufacturing facilities to be loaded into manufacturing machines that actually create the logic or processor. Some embodiments may be implemented using, for example, a machine-readable medium or article that may store instructions or sets of instructions that, when executed by a machine (e.g., logic circuitry), cause the machine to perform methods and / or operations according to the embodiments. Such a machine may include, for example, any suitable processing platform, computing platform, computing device, processing device, computing system, processing system, computer, processor, logic circuitry, etc., and may be implemented using any suitable combination of hardware and / or software. A machine-readable medium or article may include, for example, any suitable type of memory unit, memory device, memory article, memory medium, storage device, storage article, storage medium, and / or storage unit, e.g., memory, removable or non-removable media, erasable or non-erasable media, writable or rewritable media, digital or analog media, hard disk, floppy disk, compact disk read-only memory (CD-ROM), recordable compact disk (CD-R), rewritable compact disk (CD-RW), optical disk, magnetic media, magneto-optical media, removable memory cards or disks, various types of digital versatile disks (DVDs), tape, cassette, etc. The instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, etc., implemented using any suitable high-level, low-level, object-oriented, visual, compiled and / or interpreted programming language.

[0087] The foregoing description has broad applicability and is presented for purposes of illustration and explanation, and is not intended to limit the present disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from the concept, spirit, or scope or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the present disclosure may be combined in alternative aspects, embodiments, or configurations. While the present disclosure is presented in terms of embodiments, it should be understood that various individual features of the present subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the present subject matter or such individual features. Those skilled in the art will understand that the present disclosure can be used with many modifications, or modifications of the structure, arrangement, proportions, materials, components, and the like used in implementing the disclosure, that are particularly adapted to particular environments and operating requirements, without departing from the principles or spirit or scope of the disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or changed, and sizes or dimensions of elements may be changed. Similarly, although operations or actions or steps are described in a particular order, this should not be construed as requiring such a specific order to achieve desirable results, or that all operations or actions or steps should be performed. Additionally, other implementations are within the scope of the following claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the above, individual features of any embodiment may be used and claimed separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0088] In the foregoing description and in the claims that follow, it will be understood that: As used herein, the terms "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. Terms such as "a," "an," "the," "first," and "second" do not exclude a plurality. For example, the term "a" or "an" entity, as used herein, refers to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another and do not limit the related elements, particularly with respect to the location, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between and relative movement between a collection of elements unless otherwise indicated. Thus, connection references do not necessarily suggest that two elements are directly connected and in a fixed relationship to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0089] The following claims are incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. In addition, although individual features may be included in different claims, they may be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, a reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

[0090] All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of the present disclosure have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that modifications can be made to the devices and / or methods, and to the steps or sequence of steps of the methods, disclosed herein without departing from the concept, spirit, and scope of the present disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims.

Claims

[Claim 1] The invention described in the specification.

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