Systems and methods including a linked localizer

Abstract

The present application provides systems and methods including two or more localization agents linked together by a linker. For example, the present application provides systems and methods for placing two or more linked localization devices within a biological system and detecting such localization devices for targeted surgery or other medical procedures. For example, the present application provides systems including one or more miniature detectable devices linked together that are placed into a target localization and activated by a remotely introduced magnetic field.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 078,971, filed September 16, 2020, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This application provides systems and methods for including two or more localization agents linked together by a linker. For example, this application provides systems and methods for placing two or more linked localization devices within a biological system and detecting such localization devices for targeted surgery or other medical procedures. For example, this application provides a system including one or more miniature detectable devices linked together, which are placed in a target location and activated by remotely introducing a magnetic field. Background Technology

[0004] For many medical procedures, the accurate localization of the treatment area is a common and significant challenge. For example, locating lesions (such as tumors) to be treated (including surgical removal) has always been a challenge for the medical community. Existing systems are expensive, complex, time-consuming, and often uncomfortable for patients.

[0005] Recent methods for tissue localization in medical procedures involve the use of positioning agents, such as RFID tags, that can be placed inside the patient. However, these tags may migrate within the patient between placement and the execution of the surgical procedure, resulting in inaccurate marking of the desired location within the patient. Furthermore, the tag orientation may shift after placement within the patient, leading to a loss of accuracy in identifying the tag's 3D location within the patient. Larger patients may present additional efficacy problems, where the signal strength generated by a single tag may be insufficient to be detected due to the volume of the tissue present.

[0006] Therefore, there is a need for improved systems and methods for organizational positioning in medical procedures. Summary of the Invention

[0007] This application provides systems and methods for including two or more locators (e.g., “tags”) linked together by a linker. For example, this application provides systems and methods for placing two or more linked tags within a biological system and detecting such tags for targeted surgical or other medical procedures. While the following description uses examples of human surgical procedures to illustrate the invention, it should be understood that the invention is not limited thereto and includes applications in veterinary medicine, agriculture, industry, machinery, military (e.g., sensing and removal of hazardous materials from objects or areas), aerospace, and the like.

[0008] In some embodiments, this application provides systems comprising one or more of the following: a) at least two tags, b) a linker attached to each of the at least two tags; c) a remote activation device (e.g., an excitation assembly) generating a magnetic field (e.g., a time-varying magnetic field) in the area of ​​each tag; and d) a plurality of sensors configured to detect signals from the tags when the at least two tags are exposed to the magnetic field.

[0009] Each of the at least two tags is attached (e.g., linked) to at least one other tag via a linker. Tags that are linked to each other via a linker are referred to in this application as “link tags”.

[0010] In some embodiments, the connector is a flexible connector. In some embodiments, the connector comprises plastic. In other embodiments, the connector comprises a shape memory alloy. For example, the connector may comprise a nickel-titanium alloy (e.g., Nitinol 60 or Nitinol 55).

[0011] In some implementations, the at least two labels are positioned at an angle ranging from 15 to 40 degrees. In some implementations, the angle is 25 degrees.

[0012] In some embodiments, the connector includes a gripper that can be held by a surgical instrument. In some embodiments, the gripper is a ball. In some embodiments, the connector is positioned within an encapsulation that includes a slot exposing the gripper.

[0013] In some embodiments, the connector includes a torsion spring. In some embodiments, each of the labels is attached to the connector via heat shrink tubing.

[0014] In some embodiments, the linker is configured to hold the labels in a first position when the at least two labels are present in the insertion device. In some embodiments, the linker is configured to hold the labels in a second position when present in the tissue, wherein at least one of the labels in the second position points generally along the X dimension and at least one of the labels points generally along the Y dimension. In some embodiments, the at least two labels include a first label, a second label, and a third label. In such embodiments, the second position is such that: i) the first label points generally along the X dimension, ii) the second label points generally along the Y dimension, and iii) the third label points generally along the Z dimension.

[0015] In some embodiments, the system also includes a wire or line. The wire or line may be attached to and / or pass through the connector at two or more points on the connector. For example, the wire or line may be attached to and / or pass through the connector such that the two or more tags are held in a first position relative to each other. When the wire or line is not attached to and / or does not pass through the connector, the connector may be configured to hold the two or more tags in a second position. This second position may differ from the first position.

[0016] In some embodiments, these tags are programmed to respond to the signal at an offset frequency compared to the signal from the magnetic field. In some embodiments, these tags include a non-dielectric resonant antenna capacitor.

[0017] In some embodiments, each of the at least two tags includes an antenna, wherein each tag transmits sidebands at a set frequency when activated by a magnetic field. In some embodiments, each tag antenna includes a coil antenna. For example, each coil antenna may include a ferrite core coil antenna.

[0018] In some implementations, each coil antenna resonates at 100kHz-200kHz. Each coil antenna may resonate at the same or substantially the same frequency. Alternatively, each coil antenna may resonate at different frequencies.

[0019] In some embodiments, the remote activation device includes at least one excitation coil. In some embodiments, the remote activation device includes two or more excitation coils configured to allow current to flow in a clockwise or counterclockwise direction, such that the magnetic field generated by the remote activation device can be selectively generated along one or more of the X, Y, and Z directions (e.g., to ensure that the tags can be energized for multiple or any angles where they can be placed). In some embodiments, the magnetic field is generated along two or more of the X, Y, and Z directions. In some embodiments, the magnetic field is generated along each of the X, Y, and Z directions.

[0020] In some embodiments, the remote activation device includes four or more excitation coils. In some embodiments, these excitation coils are connected in series. In some embodiments, four of the excitation coils are arranged in two rows centered at coordinates (X1,Y1), (X1,Y2), (X2,Y1), and (X2,Y2). In some embodiments, the remote activation device (e.g., an excitation assembly) includes at least one of three current flow configurations: a) all current flows clockwise to simulate an excitation coil aligned orthogonal to the Z-axis; b) the excitation coil centered at (X2,Y1), (X2,Y2) has current flowing counterclockwise to simulate an excitation coil aligned with the X-axis; and c) the excitation coil centered at (X1,Y2), (X2,Y2) has current flowing counterclockwise to simulate an excitation coil substantially aligned with the Y-axis. In some embodiments, the remote activation device includes all three or more current flow configurations.

[0021] In some embodiments, the remote activation device (e.g., an excitation assembly) includes multiple relays that provide switching functionality to allow for changes in current direction (polarity), but maintain the excitation frequency by switching additional capacitive reactance. In some embodiments, as the total inductance increases, the switching functionality inserts additional series capacitive reactance via a capacitive element, such that the tuning center frequency is maintained at the excitation frequency (e.g., when using four coils, the total inductance of the four coils changes with the current direction within each coil or coil pair). In some embodiments, the capacitive element consists of multiple capacitors (e.g., to better accommodate the voltage potential at resonance and / or to provide greater flexibility with respect to frequency tuning). In some embodiments, the remote activation device also includes a balun near these excitation coils. The balun eliminates common-mode currents that would otherwise generate unwanted electric field components, which could potentially reduce accuracy. The balun also provides impedance transformation to match the real component of the coil impedance to the transmission line (typically 50 ohms). In some embodiments, the balun has eight turns on the primary side (amplifier side) and four turns on the secondary side (coil side). In some embodiments, the system also includes an amplifier in electronic communication with the remote activation device. In some embodiments, the system also includes a computer that controls magnetic field generation and sensor detection. In some embodiments, the computer includes a trapping algorithm (e.g., embodied in software running on a processor) that adjusts the orientation of the magnetic field to identify (and drive) optimal detection of at least two tags.

[0022] This application also provides the use of any of the above systems (e.g., for detecting the position of two or more link tags in an object; for detecting the position of two or more link tags relative to a medical device, etc.).

[0023] This application also provides methods for identifying the location of two or more linked tags, the methods comprising: a) providing any of the systems described in this application; b) placing the at least two tags in an object; c) generating a magnetic field using the activation device; and d) identifying the location of the tags in the object by collecting information emitted from each tag using a measurement witness station. In some embodiments, the location includes the relative position or distance of the tag to a medical device.

[0024] In some embodiments, placing the at least two labels in an object includes: positioning the at least two labels in the object using an introduction device. In some embodiments, the at least two labels are arranged in a first position within the introduction device. In some embodiments, the at least two labels migrate to a second position when placed in the object. In some embodiments, at least one of the labels in the second position points generally along the X-axis, and at least one of the labels points generally along the Y-axis. In some embodiments, the at least two labels include a first label, a second label, and a third label, and wherein when in the second position: i) the first label points generally along the X-axis, ii) the second label points generally along the Y-axis, and iii) the third label points generally along the Z-axis.

[0025] definition

[0026] As used in this application, the terms "processor" and "central processing unit" or "CPU" are used interchangeably and refer to a device capable of reading a program from computer memory (e.g., ROM or other computer memory) and executing a set of steps according to that program.

[0027] As used herein, the terms "computer memory" and "computer memory device" refer to any storage medium that can be read by a computer processor. Examples of computer memory include, but are not limited to, RAM, ROM, computer chips, digital video discs (DVDs), optical discs (CDs), hard disk drives (HDDs), optical discs, and magnetic tapes. In some embodiments, the computer memory and computer processor are part of a non-transitory computer (e.g., in a control unit). In some embodiments, non-transitory computer-readable media are used, wherein non-transitory computer-readable media includes all computer-readable media, with the only exception being transient propagated signals.

[0028] As used in this application, the term "computer-readable medium" means any device or system used to store information and provide information (e.g., data and instructions) to a computer processor. Examples of computer-readable media include, but are not limited to, DVDs, CDs, hard disk drives, magnetic tapes, and local or remote (e.g., cloud-based) servers used for streaming media over a network.

[0029] As used in this application, the term "electronic communication" refers to electronic devices (e.g., computers, processors, etc.) configured to communicate with each other via direct or indirect signaling. Similarly, a computer configured to transmit information to another computer or device (e.g., via cables, wires, infrared signals, telephone lines, radio waves, etc.) communicates electronically with another computer or device.

[0030] As used in this application, the term "transfer" refers to moving information (e.g., data) from one location to another (e.g., from one device to another) using any suitable means.

[0031] As used in this application, the term "alloy" refers to a combination of a metal with at least one other metal or nonmetal. The term "shape memory alloy" refers to an alloy that may deform when cooled but recovers its original shape (e.g., "memory") when heated.

[0032] As used in this application, the terms "subject" or "patient" refer to any animal (e.g., a mammal) that is to become a recipient of a particular treatment, including but not limited to humans, non-human primates, companion animals, livestock, horses, rodents, etc. Generally, the terms "subject" and "patient" are used interchangeably in this application when referring to human subjects.

[0033] As used in this application, the term "subject / patient suspected of having cancer" refers to a subject presenting with one or more symptoms indicative of cancer (e.g., a noticeable lump or mass) or a subject undergoing cancer screening (e.g., during a routine physical examination). Subjects suspected of having cancer may also have one or more risk factors. Subjects suspected of having cancer generally do not undergo cancer testing. However, "subject suspected of having cancer" encompasses individuals who have received an initial diagnosis (e.g., a CT scan showing a lump) but whose cancer stage is unknown. The term also includes individuals who have previously had cancer (e.g., individuals in remission).

[0034] As used in this application, the term "biopsy tissue" refers to a sample of tissue (e.g., breast tissue) removed from a subject for the purpose of determining whether the sample contains cancerous tissue. In some embodiments, a biopsy tissue is obtained because the subject is suspected of having cancer. The biopsy tissue is then examined for the presence of cancer (e.g., by microscopy; by molecular testing).

[0035] As used herein, the term "linker" refers to a suitable material for attaching one label to another. A linker may comprise any suitable material. For example, a linker may comprise plastic. Alternatively, a linker may comprise a shape memory alloy.

[0036] As used in this application, the term "link tag" refers to a group of at least two tags, wherein at least one tag is attached to at least one other tag via a linker. The term may refer to two attached tags. The term may refer to three or more tags, wherein each tag is attached to at least one other tag via one or more linkers.

[0037] As used in this application, the term "tag" or "marker tag" refers to a small implantable tag that, when excited by a time-varying magnetic field of an exciter, emits a "homing beacon" spectrum at a frequency received by a measuring reference coil and used to determine its location. This spectrum can be programmed to generate a unique spectrum, thus allowing multiple tags to be implanted and located simultaneously. Attached Figure Description

[0038] Figure 1 An exemplary positioning of a patient with an excitation assembly, a medical device with an attached display component, and a tag implanted next to a tumor is shown.

[0039] Figure 2 An attachment member 10 is shown attached to a medical device 20, which has a device tip 25. The attachment member 10 has two positioning transmitters 70 located therein. The attachment member 10 is attached to or integrated with a display member 40.

[0040] Figure 3 An exemplary coil configuration of the excitation assembly is shown.

[0041] Figure 4A An exemplary excitation assembly 250 is shown attached to the controller 210 via a cable bundle 200. Figure 4B An exemplary measurement reference coil assembly (also known as a measurement reference station assembly) 161 is shown. Figure 4C An exemplary measurement reference coil 160 is shown, which includes wires wound along it to form a coil 167 on a metal core 166 in three directions.

[0042] Figure 5 An exemplary excitation assembly with four excitation coils (coils AD) is shown, wherein current flows in a clockwise direction in all four excitation coils.

[0043] Figure 6An exemplary excitation assembly with four excitation coils (coils AD) is shown, wherein current flows clockwise in coils A and B and counterclockwise in coils C and D.

[0044] Figure 7 An exemplary excitation assembly with four excitation coils (coils AD) is shown, wherein current flows clockwise in coils A and C and counterclockwise in coils B and D.

[0045] Figure 8 An exemplary excitation assembly 250 with a top cover 230 is shown. The excitation assembly 250 is shown having a cable bundle 200 guided therein.

[0046] Figure 9 An exemplary attachment member 10 is shown, which has an angled distal end 300 through which the distal tip 25 of the medical device 20 is inserted.

[0047] Figure 10 A shows the distal end 25 of the medical device 20 after initial insertion through the angled distal end 300 of the attachment member 10. Figure 10 B shows the attachment component wire 60 before it is attached to the cable management component 315 of the display component housing 330. Figure 10 B shows the attachment component wire 60 before it is attached to the cable management component 315 of the display component housing 330. Figure 10 B also shows a housing tapered connector 340, into which a proximal end tapered connector 350 of the attachment member 10 is inserted. The cable management component 315 has two clamps that attach to and align the attachment member wire 60 and the medical device wire 50.

[0048] Figure 11 An exemplary attachment member 10 is shown attached to a display component housing 330. The attachment member 10 has a pair of positioning transmitters 70 linked to positioning transmitter lead wires 72 located inside a tube 360. The attachment member also has an angled distal end 300 with a distal end opening 305, which allows the tip of a surgical or other device to be inserted therethrough. The display component housing 330 has a cable management member 315 consisting of a pair of clamps for retaining insulated wires.

[0049] Figure 12An exemplary attachment member 10 is shown, attached to a display member housing 330 therein. A display cover 370 is shown for securing the display member 40 inside the display member housing 330. An adhesive strip 380 is also shown, the shape and size of which are configured to fit inside the attachment member and facilitate securing a medical device to the attachment member.

[0050] Figure 13 A shows a proximal end tapered connector 350 of the attachment member 10, which is configured to be pushed into a housing tapered connector 340 of the display member housing 330. Figure 13 B shows Figure 13 A close-up of section A, which includes a cable management tapered connector 317, part of the cable management component 315 and designed to insert into a tapered connection hole 319 in the display component housing 330. The cable management tapered connector 317 includes a flat portion 318 for locking angular position.

[0051] Figure 14 An exemplary system for positioning a tag implanted in a patient is shown. The system comprises an excitation assembly that emits a signal to activate the tag within the patient's body. The system's electronic housing is shown as a mobile trolley that delivers signals to the excitation assembly and receives and processes signals from the tag within the patient's body. Surgical guidance is displayed on a display component and a screen on the system's electronic housing.

[0052] Figure 15 An exemplary arrangement of two tags connected by a Nitinol connector is shown.

[0053] Figure 16 An exemplary arrangement of two labels is shown, which are connected by a Nitinol connector and a wire or cord containing a crimping member and a self-tightening washer.

[0054] Figure 17 An exemplary arrangement of two labels connected by a linker is shown.

[0055] Figure 18 The package shows Figure 17 The arrangement. Detailed Implementation

[0056] This application provides systems, devices, components, and methods for locating two or more tags linked by a linker in tissue, such as that of a patient. For example, this application provides systems, devices, and methods employing one or more of the following: a) two or more linked tags placed in an object such as a patient; b) a remote activation device that generates an electromagnetic field within the area of ​​the tag; c) a plurality of sensors (e.g., a measurement reference station) receiving information from the tag already exposed to the electromagnetic field; d) one or more transmitters positioned on a medical device, exposed to the electromagnetic field, and emitting information received by the sensors (e.g., the measurement reference station); and e) a computer system for analyzing the information received by the sensors and generating and displaying information about the location of the medical device and / or one or more tags (e.g., relative positioning, relative distance, orientation, etc.).

[0057] These systems, devices, components, and methods are found to be useful in a variety of applications, including medical applications for locating linked tags in human subjects. While this specification focuses on medical uses in human tissues, it should be understood that these systems and methods are found to have broader uses, including non-human uses (e.g., for non-human animals, such as livestock, companion animals, wildlife, or any veterinary setting). For example, the system can be used in environmental, agricultural, industrial, and other settings. In some embodiments, the systems, devices, components, and methods are found to be used in electromagnetic navigation systems that power remote tagging devices with a sinusoidal magnetic field (see, for example, U.S. Patent Nos. 9,730,764 and U.S. Application Serial Nos. 15 / 281,862 and 15 / 674,455, which are incorporated herein by reference in their entirety).

[0058] In some embodiments, this application provides systems comprising: at least two tags, each tag being attached to at least one other tag via a linker; a remote activation device that generates a magnetic field within an area of ​​each tag; and a plurality of sensors configured to detect signals from each tag when each tag is exposed to the magnetic field.

[0059] In some embodiments, the tag is wireless and ideally has a minimal size. In some embodiments, when powered, the tag generates its own time-varying magnetic field at one or more sideband frequencies. The shape of the magnetic field approximates the shape of a magnetic dipole located at the tag. The tag's location is identified by monitoring the magnetic field at several locations using a receiving antenna coil (also called a sensor, sensing coil, measurement reference coil, or measurement reference station). In some embodiments, the system, apparatus, components, and methods also include an electrosurgical tool. In some embodiments, the electrosurgical tool, or a component attached to or physically close to the tool, includes two or more positioning transmitters that also generate a magnetic field similar to a magnetic dipole. In some embodiments, the positioning transmitters are driven by two different frequency signals, which are also different from the exciter frequency and the tag response frequency. In some embodiments, the positioning transmitters are connected to the signal supply source by wires.

[0060] In some implementations, a single excitation component is used (e.g., such as...). Figure 4A (As shown) to generate signals that interact with the tag and the positioning transmitter in the attachment associated with the electrosurgical instrument. In some embodiments, the excitation assembly is contained in a single thin component. In some embodiments, the assembly including the exciter also includes a sensor (e.g., a receiving antenna / sensing / measuring reference station coil). In some embodiments, the excitation assembly is configured to be deployed below a patient undergoing a medical procedure. Figure 1 An exemplary protocol configuration is illustrated, in which a patient 90 is positioned on a surface 95 (e.g., a mattress or operating table). Surface 95 is held by a surface frame 97. The patient 90 has a lesion (e.g., a tumor) 110 and an implantable tag 100 positioned near, on, or within the tumor. An excitation assembly 250 is positioned below the patient and below the surface (e.g., positioned on the surface frame 97) and generates an electromagnetic field (not shown) in a region around the patient that encompasses the positions of the tag 100 and the medical device 20 (e.g., a surgical instrument) in the surgical area above the patient.

[0061] Figure 2 An exemplary electrocautery surgical device (e.g., BOVIE) discovered for use in some embodiments of the present invention is shown. Device 20 includes a tip 25 providing a surgical surface for treating tissue, two embedded positioning transmitters 70 allowing the system to sense the positioning and location of device 20, and a display unit 40 providing visual information to a user (e.g., a surgeon) regarding the positioning of a label within the patient's body.

[0062] In some implementations, the excitation component is configured to provide enhanced detection of remote objects (e.g., tags and surgical equipment) in many different environments that would otherwise complicate localization, position, and distance assessments (especially real-time assessments of such factors).

[0063] In some embodiments, the system and method include multiple components. In some embodiments, the first component includes at least two link tags (which may be used interchangeably with the term "tag") whose location, position, distance, or other attributes will be evaluated. The link tags described in this application have been found to be used in a variety of systems and methods, such as those disclosed in WO2018031826A1, WO2017059228A1, WO2019236600A1, and WO2015112863A1, the entire contents of each of which are incorporated herein by reference. In some embodiments, the system and method may include two, three, four, five, or more than five link tags. In some embodiments, the system and method include two link tags. For example, the system and method may include two link tags "A" and "B" which are attached to each other by a linker. Alternatively, the system and method may include three or more link tags. In such embodiments, the link tags are in the sense that each tag is attached to at least one other tag by the same or different linkers. For example, three tags can be linked, where tag "A" is attached to tag "B" via a linker, and tag "B" is attached to tag "C" via a linker. In some implementations, at least one tag can be attached to two or more tags. For example, three tags can be linked, where tag "A" is attached to tag "B", tag "B" is attached to tag "C", and tag "C" is attached to tag "A".

[0064] The tags are linked by a suitable connector. The connector may contain any suitable material for attaching one tag to another. For example, the connector may contain plastic. Alternatively, the connector may contain a shape memory alloy. In some embodiments, the shape memory alloy connector may contain any one or more metals selected from copper, iron, aluminum, nickel, titanium, manganese, silicon, zinc, or gold. For example, the shape memory alloy may be a nickel-titanium alloy (e.g., nitinol). Another example is a copper-aluminum-nickel alloy. The metals in the shape memory alloy may be present in any suitable amount to achieve the desired alloy properties. For example, for nitinol, the atomic percentages of nickel and titanium present typically range from 55% to 60% nickel and 40% to 45% titanium (by weight). For example, nitinol 55 contains 55% nickel and 45% titanium. Alternatively, nitinol 60 contains 60% nickel and 40% titanium (wt%).

[0065] refer to Figure 15 A first label 500A and a second label 500B are coupled to a connector 504. The first label 500A and the second label 500B are glass labels, which are mechanically coupled to the connector 504 via heat-shrink tubing 508 (or other similar retaining device). The connector 504 is made of nitinol wire and includes a torsion spring 512 positioned between the first label 500A and the second label 500B.

[0066] In some implementations, the connector holds two or more link tags in a first position before placement in the subject, and the link tags are subsequently shaped into a second position after placement in the subject. For example, the link tags may be held in a first constrained arrangement before placement in the subject, such that the link tags engage within an induction device for positioning the link tags within the subject. This can be achieved using a plastic connector that is folded or bent to allow the link tags to engage within the induction device. Alternatively, this can be achieved using a shape memory alloy connector that can be cooled and molded into a first position to allow placement within the induction device. For example, the first position may include a linear shape such that each of at least two tags is oriented in a straight line to engage within the induction device (e.g., a cannula). The link tags may then begin to be in a second position after positioning in the subject. For example, a shape memory alloy (e.g., nitinol) connector may be refolded into a memory shape (e.g., L-shape, T-shape, V-shape, etc.) after positioning in the subject. For example, the connector may be plastic, which can be folded or bent to allow the connector tag to fit within an insertion device (e.g., a cannula), and the plastic connector may unfold upon positioning within the subject's body to allow the connector device to begin in a second position. Alternatively, a shape memory alloy connector will be heated to the subject's body temperature upon positioning within the subject's body, thereby allowing the alloy to return to its "memory" shape.

[0067] The second location (e.g., the arrangement of the link tag after it has been positioned within the subject) can be any suitable arrangement. For example, for an embodiment with two link tags, the second location can be L-shaped, T-shaped, V-shaped, or X-shaped. Similarly, for an embodiment with three or more link tags, depending on the number of link tags, the second arrangement can be a shape such as a triangle, square, rectangle, etc. Any of the above arrangements will allow for improved anchorage of the link tag within the subject's tissues. In some embodiments, the link tag is configured to be placed at a surgical or other clinically relevant location within the subject to mark a target area within the body.

[0068] In some implementations, when in the second position, the tags are separated by an angle ranging from approximately 15° to approximately 40° (i.e., the tag separation angle). In some implementations, the tags in the second position are separated by approximately 30° to improve six-degree-of-freedom positioning. In some implementations, the tags in the second position are separated by approximately 25° to improve six-degree-of-freedom positioning. The tags advantageously form sufficiently large angles relative to each other to establish a complete six-degree-of-freedom coordinate system, while also forming sufficiently small angles relative to each other so that both tags can be powered simultaneously. A 0° angle between the tags does not allow for the establishment of a complete six-degree-of-freedom coordinate system because the tag signal does not change as the tag rotates about its major axis. Similarly, a 90° angle between the tags is not preferred because when one tag is fully aligned with the exciter field and receives full power, the other tag will not receive any power. A 90° angle between the tags is also not preferred if one tag points to the center of the other tag because it is ambiguous when the entire structure is flipped (i.e., T has mirror symmetry, while L does not).

[0069] In some embodiments, the second position can be achieved using one or more additional facilitating features (e.g., wires, threads, crimping elements, washers, etc.). For example, at least two tags can be linked by a shape memory alloy. A connector and / or tag can be attached to a wire or thread, which may also include crimping elements, washers, etc., to ensure that at least two tags achieve the desired arrangement. For example, the wire or thread may contain crimping elements, and the spacing between the crimping elements will determine the angle used to link the at least two tags (e.g., the angle of the shape memory alloy linking the tags). In some embodiments, the first position of the at least two tags (e.g., arrangement within the device) can be a straight line, and the wire / thread can be pulled after the device is placed in the subject's body, causing the crimping elements to apply appropriate pressure on the linked tags / shape memory alloy, thereby causing the alloy to bend to achieve the desired second position within the subject's body. In some embodiments, after achieving the second position, the wire / thread can be cut and subsequently removed from the subject's body. Figure 16 Exemplary implementations using these additional facilitating features are shown in the figure.

[0070] refer to Figure 16A first label 600A and a second label 600B are mechanically coupled to a connector 604. The first label 600A and the second label 600B are glass labels, which are held by a clamp 608 cut and formed into the connector 604. In the illustrated embodiment, the connector 604 is cut and formed as a nitinol tube having a bend 612 positioned between the first label 600A and the second label 600B. A wire 616 (or line) extends between a first end 620 and a second end 624 of the connector 604. In the illustrated embodiment, the wire 616 passes through a hole formed in both the first end 620 and the second end 624. Crimping members 628A, 628B are positioned along the wire 616 to form positioning stops, and a self-tightening washer 632 is adjustably positioned along the wire 616. The self-tightening washer 632 is configured to slide along the wire 616 to adjust the relative position of the first end 620 along the wire 616 with respect to the second end 624.

[0071] refer to Figure 17 The first label 700A and the second label 700B are mechanically coupled to the connector 704. The first label 700A and the second label 700B are held to the connector 704 by corresponding clamps 708 formed on the connector 704. The connector 704 is a nitinol link having a curved portion 712 positioned between the first label 700A and the second label 700B. In the illustrated embodiment, the connector 704 includes a gripping portion 716 located at a first end 720 of the connector 704. In the illustrated embodiment, the gripping portion 716 is a ball, configured to be grasped, for example, by surgical clamps. Thus, the labels 700A, 700B and the connector 704 are easily manipulated by surgical tools or instruments.

[0072] refer to Figure 18A first label 700A, a second label 700B, and a connector 704 are positioned within a sheath 724 for easy deployment into a bronchoscope, endoscope, etc. The sheath 724 is configured to engage with the working channel of the endoscope. Typically, the working channel includes interruptions, and the sheath 724 prevents the connector 704 and labels 700A, 700B from being caught or stuck on those interruptions. The sheath 724 is long enough to extend through features within the working channel, but short enough not to extend to places where the working channel bends into anatomical structures. In some embodiments, the sheath 724 includes a length ranging from approximately 100 cm to approximately 180 cm. The sheath 724 surrounds the connector 704 (holding the connector 704 in a first position), except that a gripper 716 is exposed. The gripper 716 can be held by a surgeon's clamp. In other words, the sheath 724 includes a notch 728 exposing the gripper 716. Once gripped, the clamps are used to push tags 700A, 700B, and connector 704 to the deployment location. Tags 700A, 700B, and connector 704 are retrievable until they are released into the proper position, prior to reaching the deployment location. This allows connector 704 to be retrievable if difficulties are encountered before it reaches the proper position.

[0073] Using at least two linked tags offers an advantage over using only a single tag because it ensures the detection of at least one tag while generating fewer exciter field directions. Therefore, tags can be placed in different orientations within the subject without the risk of missing detection of at least one of the two linked tags. In some embodiments, the linker is configured to hold these tags in a second position when present in tissue, wherein at least one of the tags in the second position is generally oriented along the X-axis and at least one of the tags is generally oriented along the Y-axis. In some embodiments, three tags are used in the second position: i) a first tag is generally oriented along the X-axis, ii) a second tag is generally oriented along the Y-axis, and iii) a third tag is generally oriented along the Z-axis.

[0074] Any suitable spacing can be used between each of the two or more link tags. For example, two or more link tags can be spaced apart from each other at a suitable distance to allow the tags to mark a target area within the body (e.g., a tumor). In such embodiments, the appropriate spacing between each of the at least two tags can be determined based on the estimated size and shape of the target (e.g., a tumor). In some embodiments, the spacing between each link tag in the link tags is the same. In some embodiments, the spacing between two or more link tags in the link tags is variable (e.g., the distance between tags A and B may be different from the distance between tags A and C or the distance between tags B and C). In some embodiments, the first tag and the second tag are separated by at least approximately 2 mm to reduce cross-coupling effects.

[0075] In some embodiments, the second component includes a remotely activated device (e.g., an excitation assembly) that generates a magnetic field. In some embodiments, the second component is located in a device positioned near (e.g., below) the subject containing the linked tag. In some embodiments, the third component includes multiple sensors (e.g., a measurement reference station) configured to receive signals generated by the tag upon exposure to the magnetic field generated by the second component. In some embodiments, the second and third components are physically contained in the same device (e.g., as shown in the image). Figure 4A (As shown). In some embodiments, the fourth component includes a medical device positioning transmitter. The fourth component may be integrated into the medical device or attached to or otherwise associated with an attachment component (e.g., a sheath). The fourth component includes one or more positioning transmitters (e.g., antennas or other types of transmitters that generate signals via electrical feeds or when exposed to a magnetic field generated by the second component, which can be detected by the third component. In some embodiments, the fifth component includes a computing device including a processor that receives information from a measurement reference station of the third component and generates information about the relative position, distance, or other characteristics of the tag, the medical device, and the measurement reference station. In some embodiments, the fifth component includes a display that shows such generated information to a user of the system.

[0076] In some embodiments, the first component consists of two or more labels (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, etc.). In some embodiments, the labels are of the same type. In other embodiments, the labels are of different types.

[0077] Any number of tags can be used. In some embodiments, at least one of the link tags contains or is composed of ferrispheres or particles. When the ferrisphere is introduced into the magnetic field, it creates irregularities in the alternating magnetic field that can be detected by the induction coil contained within the measuring reference station, resulting in a phase and amplitude shift from zero. Zero is restored when the ferrisphere is physically equidistant from the two sensing coils.

[0078] In some embodiments, at least one of the linked tags includes a ferrite core coil antenna (e.g., resonating at 100 kHz–200 kHz) coupled to an integrated circuit (IC), which is powered by an AC magnetic field at the resonant point. In some embodiments, the core is contained within a housing (e.g., a cylindrical glass or plastic shell). In some embodiments, the excitation antenna is driven by a conventional oscillator and power amplifier at a level sufficient to power the tag. In some embodiments, the implanted tag amplitude modulates (AM) the continuous wave (CW) carrier power from the exciter, thereby transmitting sidebands at a frequency set by a number programmed into a tag counter. In some embodiments, these sidebands, along with the stronger CW carrier, are ultimately detected by a third component.

[0079] In some embodiments, at least one link tag in the link tag includes a self-resonant object (e.g., a small ferrite core with a wire-wound inductor). The wire-wound inductor has an inter-winding capacitance that, combined with the inductance, creates a high-frequency resonant circuit. In some embodiments, at least one link tag in the link tag includes a resonant object (e.g., a self-resonant object equipped with a chip capacitor to generate resonance at a specified frequency). In some embodiments, the chip capacitor is not a dielectric resonant antenna, but a standard thin-film capacitor or a multilayer ceramic capacitor (MLCC). Dielectric resonant antenna capacitors may be less suitable for use in this method because they are less effective at low frequencies (e.g., 100 kHz–200 kHz). In contrast, standard thin-film capacitors or MLCCs can be formed to provide consistent functionality at low frequencies (e.g., 100 kHz–200 kHz). Furthermore, standard thin-film capacitors or MLCCs can be fabricated to provide temperature-independent consistent functionality, making them effective at both ambient and body temperatures (e.g., once placed inside a subject). Additionally, standard thin-film capacitors or MLCCs are less expensive than dielectric resonant antennas.

[0080] In some embodiments, the tag includes a resonant or self-resonant object with a diode. A diode combined with an LC circuit generates a subharmonic frequency when immersed in a sufficiently strong magnetic field (with an applied voltage exceeding the diode's bandgap potential). In some embodiments, the tag includes a resonant or self-resonant object with an active modulator (e.g., an integrated circuit amplitude modulating the resonant circuit). In some embodiments, detection occurs similarly to full-duplex (FDX) radio frequency identification (RFID), except that the modulation pattern is a simple subharmonic rather than an encoded binary pattern; in some embodiments, detection occurs similarly to a half-duplex (HDX) operating mode after excitation.

[0081] In some implementations, at least one of the link tags is configured for single-use. In some such implementations, the link tag can be disabled or deactivated (e.g., like an EAS tag). This is particularly useful when multiple tags are used in a procedure, where disabling a single tag makes detection of other tags easier (e.g., to avoid or reduce interference between multiple tags). In some implementations, a burst of energy from an external device is used to disable or deactivate the tag. In other implementations, at least one of the link tags has an internal control component that opens or closes the tag upon receiving a command from an external device (e.g., the tag temporarily or permanently stops "talking").

[0082] In some implementations, each link tag in the link tag has an outer length, width, and depth, wherein the length is 30 mm or less (e.g., 20 mm or less, ..., 10 mm or less, ..., 9 mm or less, ..., 8 mm or less, ..., 5 mm or less, ..., 3 mm or less, ... etc.), the width is 5 mm or less (e.g., 4 mm or less, ..., 3 mm or less, ..., 2 mm or less, ..., 1 mm or less, ..., 0.5 mm or less, ... etc.), and the depth is 5 mm or less (e.g., 4 mm or less, ..., 3 mm or less, ..., 2 mm or less, ..., 1 mm or less, ..., 0.5 mm or less, ... etc.).

[0083] In some embodiments, each link tag is contained within a housing or sheath. In some embodiments, no housing is used. In some embodiments, at least one link tag is contained within a housing and at least one link tag is not contained within a housing. In some embodiments, the housing comprises a biocompatible material. In some embodiments, the housing provides a liquid and / or gas resistant barrier separating the signal source from the outside of the housing. In some embodiments, the housing is small enough to allow application of the link tags via needles, cannulas, endoscopes, catheters, or other medical devices. In some such embodiments, the housing has an external length, width, and depth, wherein the length is 30 mm or less (e.g., 20 mm or less, ..., 10 mm or less, ..., 9 mm or less, ..., 8 mm or less, ..., 5 mm or less, ..., 3 mm or less, ... etc.), the width is 5 mm or less (e.g., 4 mm or less, ..., 3 mm or less, ..., 2 mm or less, ..., 1 mm or less, ..., 0.5 mm or less, ... etc.), and the depth is 5 mm or less (e.g., 4 mm or less, ..., 3 mm or less, ..., 2 mm or less, ..., 1 mm or less, ..., 0.5 mm or less, ... etc.). The housing can have any desired shape. In some embodiments, the housing is cylindrical along its length axis. In some embodiments, the housing is shaped like a grain of rice (e.g., a cylinder with rounded ends). In some embodiments, the housing is shaped like a pillar (e.g., a cylinder with flattened ends). In some embodiments, the outer shell is polygonal along its length axis (e.g., with a triangular, square, rectangular, trapezoidal, pentagonal, etc. cross-section). In some embodiments, the outer shell has supports or other fasteners to hold the tag in place and prevent migration within the tissue. These supports can unfold when placed in the tissue. In some embodiments, the fasteners can be a biocompatible material that bonds to the surrounding tissue. Advantageously, embodiments excluding the sheath of two linked tags are able to be positioned with a tighter bending radius.

[0084] In some embodiments, the outer shell is a single, homogeneous component synthesized around the inner components of the label. In other embodiments, the outer shell is made of two or more separate segments that are sealed together after being introduced into the inner components of the label. In some embodiments, the label is wholly or partially covered in a coating. In some embodiments, the coating contains a biocompatible material (e.g., parylene-C, etc.).

[0085] In some embodiments, one or more link tags in the link tag do not include any power source. In some embodiments, each link tag in the link tag does not include any power source. For example, in some embodiments, the signal is generated from a signal source in response to a magnetic field as an activation event (i.e., electromagnetic induction).

[0086] In some embodiments, at least one link tag in the link tag includes a radio frequency identification (RFID) chip (e.g., within a housing). For example, each link tag in the link tag may include an RFID chip. In some embodiments, the RFID chip includes a radio frequency electromagnetic field coil that modulates an external magnetic field to transmit an coded identification number and / or other coded information when queried by a reader device. In some embodiments, the RFID chip collects energy from an EM field generated by a second component (or other device) and then acts as a passive transponder to emit microwave or UHF radio waves. In some embodiments, the RFID chip is read-only. In other embodiments, it is read / write. The technology is not limited by the nature of the information provided by the RFID chip. In some embodiments, the information includes serial numbers, serial numbers or batch numbers, time information (e.g., production date; surgery date, etc.); patient-specific information (e.g., name, family history, medications taken, allergies, risk factors, procedure type, gender, age, etc.); procedure-specific information, etc. The technology is not limited by the frequency used. In some implementations, the RFID frequency is in the 120kHz-150kHz band (e.g., 134kHz), 13.56MHz band, 433MHz band, 865MHz-868MHz band, 902MHz-928MHz band, 2450MHz-5800MHz band, etc. In some implementations, the RFID chip is integrated with browser-based software to improve its effectiveness. In some implementations, the software allows different groups or specific hospital staff, nurses, and patients to view real-time data related to tags, procedures, or individuals. In some implementations, real-time data is stored and archived to utilize historical reporting capabilities and demonstrate compliance with various industry regulations. In some implementations, the RFID chip reports sensor data (e.g., temperature, motion, etc.). In some implementations, the RFID chip contains or collects information to be read later (e.g., post-operatively). In some implementations, the information is reviewed during surgery. For example, a message (e.g., "The chip is exactly on the left side of the tumor") may be provided to the surgeon to help guide the surgeon (e.g., to optimize the removal of the tumor with appropriate margins).

[0087] In some implementations, each of two or more link tags consists of the same components. In other words, each link tag does not need to consist of components with different electrical properties to make the tag uniquely identifiable. In some implementations, each link tag consists of or substantially consists of a signal source and a housing, or a signal source, a housing, and an RFID chip. In some implementations, the tag (e.g., via a chip) emits an ultrasonic signal (e.g., grayscale, spectral, or color Doppler) such that the signal can be detected by an ultrasonic probe or a handheld Doppler unit.

[0088] In some embodiments, the label is heated during the procedure (e.g., by exposure to an external energy source). In some such embodiments, heating can be used to aid in the coagulation or pre-coagulation of tissue or to provide hypertherapy (see, for example, U.S. Patent Publication No. 2008 / 0213382, which is incorporated herein by reference in its entirety). Heating can also be used to improve the efficacy of radiotherapy.

[0089] In some embodiments, the second component provides a remote activation device. In some embodiments, the remote activation device includes at least one excitation coil. In some embodiments, the remote activation device includes two or more excitation coils (e.g., Figure 4A (Excitation assembly shown). In some embodiments, at least one excitation coil is disposed on the bottom substrate. The bottom substrate may be composed of any suitable material, such as polycarbonate, and is generally non-magnetic and non-conductive.

[0090] In some embodiments, the excitation coil is disposed within a patch or pad placed on the patient or operating table, although it can be positioned at any desired location within the tag's functional distance. In some embodiments, a remote activation device provides an AC magnetic field from one or more excitation antennas. In some embodiments, where the system is used to locate a breast tumor, the patch surrounds the breast being treated or is otherwise placed near the breast. Similar methods can be used for other targeted areas of the body. In some embodiments, a pad containing the excitation coil is placed under the patient. In such embodiments, a large coil or multiple coils are used. The excitation coil may comprise or consist of several turns of a flat conductor patterned on a dielectric substrate, or may comprise or consist of magnetic wire wound around a suitable mandrel; the coil is powered by an external frequency source, and the magnetic field emanating from the coil penetrates the patient's body to excite the tags, the emission of which is detected by a detection component.

[0091] In some embodiments, one or more excitation coils are contained within a strap placed around or around a portion of the subject. In some embodiments, the external excitation coil may also be used for other aspects of patient care, such as for radiotherapy or as a ground current return pad used in electrosurgery. In some embodiments, the remote activation device emits light (e.g., a laser). In some embodiments, the remote activation device is configured for single use (e.g., it is disposable).

[0092] In some implementations, the remote activation device uses an unmodulated constant frequency activation (i.e., the activation signal has a constant amplitude and frequency). In some implementations, the remote activation device uses an unmodulated scan frequency (i.e., the activation signal has a constant amplitude and a scan frequency between its two endpoints). Such devices are found to work with resonant tags such that when the transmitted frequency coincides with the tag's resonant frequency, a detectable change in the amplitude of the activation signal occurs. In some implementations, the remote activation device uses a pulse frequency (i.e., the activation signal comprises short excitation pulses of a periodic frequency, which may include two closely related frequencies whose sum or difference is the tag's response frequency). Pulse activation generates a sinusoidally decaying signal after the pulse. The tag alters the amplitude or time characteristics of the decaying signal.

[0093] The advantage of the system provided in this application is that each of the at least two linked tags can respond to a single transmission frequency (e.g., an activation signal, such as an activation signal provided by a remote activation device). In other words, the transmission frequency is common to all tags. For example, each of the at least two linked tags can be programmed to generate a unique frequency in response to a single transmission frequency provided by an activation device. The at least two linked tags can be programmed to respond to a wide range of frequencies (e.g., 100kHz–150kHz), wherein the response frequency of each tag is scaled according to the stimulus frequency.

[0094] In some embodiments, the remote activation device includes a handheld component. In some embodiments, the handheld component is lightweight to allow the surgeon to hold and manipulate it during the procedure (e.g., 5 kg or less, 4 kg or less, 3 kg or less, 2 kg or less, 1 kg or less, 0.5 kg or less, 0.25 kg or less, or any range in between, e.g., 0.5 kg to 5 kg, 1 kg to 4 kg, etc.). In some embodiments, the handheld component is shaped like a rod, having a proximal end held by the physician and a distal end pointing towards the treated subject or tissue with a linked tag. In some embodiments, the handheld component is shaped like an otoscope, having a distal end terminating at an angle (e.g., a right angle) to the body of the component. In some embodiments, the remote activation device includes an antenna that generates a magnetic field. In some embodiments, the remote activation device has only a single antenna (i.e., it is monostatic). In some embodiments, the remote activation device has only two antennas (i.e., it is bistatic).

[0095] In some implementations, the device is activated remotely (e.g., Figure 4A The magnetic field of the excitation component (shown) is controlled by a processor running a computer program. In some embodiments, the remote activation device includes a display or user interface that allows the user to control the remote activation device and / or monitor its functionality during use. In some embodiments, the remote activation device provides visual, audio, numerical, symbolic (e.g., arrow), text, or other output to help the user locate a link tag or identify the distance or direction of the tag relative to the remote activation device.

[0096] In some implementations, multiple measurement reference coils of the third component collectively provide several antennas (e.g., measurement reference antennas) at multiple predetermined locations relative to the tags and are configured to receive signals generated by one or more tags when exposed to a magnetic field generated by the second component.

[0097] In some implementations, each measurement reference coil feeds into a receiver channel, which is time-division multiplexed (TDM) to reduce receiver complexity. A fixed measurement reference station, positioned relative to the tag and to each other (e.g., arranged along a patient), comprises one or more (e.g., one to three) measurement reference coils arranged in a locally orthogonal manner to sense various components of the AC magnetic field from the tag. In some implementations, one or more or all of these measurement reference coils in the measurement reference station are also TDMed in the receiver channel, thereby reducing complexity and crosstalk between antennas.

[0098] In some embodiments, the measurement reference coil comprises or is composed of a cylindrical coil antenna loaded with ferrite (e.g., a measurement reference antenna), which is tuned (e.g., with one or more capacitors in parallel) to resonate at the frequency (e.g., 100 kHz–200 kHz) of an exciter (e.g., a tag or transmitter). Typical dimensions of the measurement reference coil are 3 mm–5 mm in diameter and 8 mm–12 mm in length, but smaller and larger sizes are possible. In some embodiments, the measurement reference antenna has a 0.25 x 1 inch ferrite core size and contains 75–80 turns of 10 / 46 (10 strands of #46) Litz wire, providing 0.157 mH (Q = 53) (75 turns).

[0099] In some implementations, each measurement reference coil is symmetrically wound around a ferrite core and connected to the secondary side of a small balun transformer via two series capacitors, each series capacitor corresponding to each wire from the coil. The total series capacitance is selected to resonate with the inductance of the coil, and the turns ratio of the balun transformer can be selected to match the practical impedance of the resonant coil / capacitor circuit to the transmission line (typically 50 ohms). The practical impedance of the resonant coil / capacitor circuit is typically 10 to 25 ohms, but can vary from only a few ohms to greater than 50 ohms, and can be adequately matched by appropriately selecting the primary and secondary turns of the balun transformer. In addition to acting as an impedance transformer, the balun also minimizes any electric field generation / susceptibility from the measurement reference coil assembly; alternatively, it can be considered as eliminating common-mode effects.

[0100] In some implementations, each measurement reference station includes one to three measurement reference antennas orthogonally oriented to each other and arranged to minimize crosstalk (i.e., interference with each other). The components housing the measurement reference station also include one or more receiver channels for collecting information acquired by the antennas of the measurement reference station. In some implementations, the receiver comprises one or more channels, or consists of one or more channels, each fed by one or more measurement reference antennas (via a multiplexer).

[0101] In some embodiments, the measurement reference station is positioned below the patient (e.g., in padding, clothing, or other equipment positioned below the patient). In some embodiments, the measurement reference station is integrated into a surgical table or imaging device in which the patient is placed during medical procedures. In some embodiments, the measurement reference station is placed on the floor, wall, or ceiling of an operating room or in a medical transport vehicle. In some embodiments, the measurement reference station is integrated into or attached to a medical device used in the medical procedure.

[0102] In some implementations, the fourth component is attached to the component (see...). Figures 9-12 The invention provides medical device positioning transmitters to allow systems to determine the location, position, distance, or other characteristics of a medical device relative to one or more tags. In some embodiments, one or more medical device positioning transmitters are integrated into the medical device or an attachment component. In other embodiments, they are attachable to the medical device. In some such embodiments, the positioning transmitter is disposed in an attachment component (e.g., a sleeve) that slides across a portion of the medical device. The positioning transmitter may operate as a tag and / or comprise the same material as a tag, but is positioned on or near the medical device, rather than within tissue. For example, in some embodiments, the transmitter includes a coil excited with a carrier wave and / or sidebands, enabling the transmitter to transmit signals as if it were a tag. In other embodiments, the positioning transmitter is wired to a power source and a signal source.

[0103] In some implementations, the localization of the transmitter is geometrically accomplished by measuring the quasi-simultaneous power detected from the transmitter at multiple measurement reference stations (e.g., four or more measurement reference stations) and using the power differences to perform vector mathematics that unambiguously determines the transmitter's localization. This process is facilitated by preliminary calibration using known tags at a known localization prior to the proceduralization.

[0104] In some embodiments, the component including the positioning transmitter (e.g., an attachment component) may also include a display to assist the user in guiding the medical device to the link tag during surgical procedures. In some such embodiments, a visual or audio display is disposed on or associated with the medical device, which receives positioning information about one or more link tags from a computer system. The display may be one or more orientation indicators, such as LEDs, indicating the direction and / or distance of the tag. Color changes may be used to indicate "on target" and "off target" positions. In some embodiments, the display includes a first display (e.g., visual, auditory, light, color, vibration, tactile, etc.) for presenting distance information to the tag; a second display (e.g., a visual, auditory, light, color, vibration, tactile, etc. display) for presenting vertical axis orientation (such as a preset preferred angle for approaching the link tag within the patient's body); and / or a third display for presenting horizontal orientation (e.g., left-to-right information that centers the surgical device as it approaches the tag). In some embodiments, the display includes multiple displays (e.g., visual, auditory, sensory, etc.) that allow for proper pitch and yaw axis positioning (to minimize damage to non-target tissues), and / or additional displays that provide distance information to the tag. In some embodiments, a series of lights and / or sounds are provided on the monitor guiding the surgeon (e.g., the surgeon attempts to keep the light centered in an "X" series of lights and / or keep the alarm volume off or as low as possible).

[0105] Vectors describing the positioning of the positioning transmitters are used to provide surgeons with visual guidance regarding the spatial relationship between the medical device (e.g., particularly its tip) and the implanted tag or (e.g., using computational guidance) and the lesion boundary. Multiple positioning transmitters are used on attachment parts attached to the medical device to provide vectors, using the same vector mathematics to determine the device's principal axes. In the case of more complex medical devices such as robotic surgical systems (e.g., the da Vinci Surgical System), multiple positioning transmitters located at multiple different locations on the device are used to provide positioning, orientation, and other positional information for multiple components of the device (e.g., arms). In some embodiments, positioning transmitters also function as detectors (e.g., providing measurement reference stations on the medical device).

[0106] In some implementations, the fifth component provides one or more computing systems, which include one or more computer processors and appropriate software to analyze, calculate, and display tag and transmitter location information (see [link to implementation]). Figure 4A(Part 210 of the document). In some embodiments, the display provides a graphical representation of the tags, patient, and / or medical device on a monitor. In other embodiments, the display provides directional information for moving or positioning the medical device. In some embodiments, the system automatically (e.g., robotically) controls the medical device or one or more of its functions. In some embodiments, the display integrates tag and / or medical device information with previously acquired or simultaneously acquired medical images of the patient or target tissue (e.g., CT, MRI, ultrasound, or other imaging modalities). For example, in some embodiments, images indicating one or more tags are fused with images of the subject's tissue or body region obtained from an imaging device. In some embodiments, information is analyzed in real time. In some embodiments, information is analyzed at one or more discrete time points.

[0107] In some implementations, the fifth component provides command and control functionality to the system user. In some implementations, the fifth component has information stored thereon that helps guide information displayed on the attachment component. For example, the information may include data about the type of medical device to which the attachment component is attached, or what tip or cutting tool is used with a particular medical device. In this regard, the precise location of the cutting tip of the medical device and its relationship to a label (e.g., distance from the label) is sent to the surgeon (e.g., for very precise instructions regarding the cutting of tissue). For example, in some implementations, such information is manually entered by the user into the control unit or attachment component, or is automatically retrieved when the component is detected to be attached to a particular medical device (e.g., via a barcode or other indicator).

[0108] This system has been found to be used with a variety of medical devices and procedures. In some embodiments, the surgical device includes an electrosurgical device that is turned on and off by the user, wherein a control unit, as part of a fifth component, allows a remotely activated device to generate a magnetic field when the electrosurgical device is off and prevents the remotely activated device from generating a magnetic field when the electrosurgical device is on (e.g., ensuring that the surgical device and the detection system do not interfere with each other). In other embodiments, the surgical device includes a power cord to which an AC current clamp is attached, wherein the AC current clamp is electrically or wirelessly linked to the control unit, wherein the AC current clamp senses when the electrosurgical device is on or off and reports it to the control unit (e.g., enabling the control unit to ensure that magnetic fields from the surgical device and from the remotely activated device do not activate simultaneously).

[0109] In some embodiments, the surgical device includes an electrocautery device, a laser cutting device, a plasma cutting device, or a metal cutting device (e.g., a surgical device manufactured by BOVIE MEDICAL). Additional examples of medical devices for use in the system embodiments are found, for example, in the following U.S. patents: 9,144,453; 9,095,333; 9,060,765; 8,998,899; 8,979,834; 8,802,022; 8,795,272; 8,795,265; 8,728,076; 8,696,663; 8,647,342; 8,628,52 4; 8,409,190; 8,377,388; 8,226,640; 8,114,181; 8,100,897; 8,057,468; 8,012,154; 7,993,335; 7,871,423; 7,632,270; 6,361,532; All of these patents are incorporated herein by reference in their entirety, and particularly with respect to the handheld medical devices disclosed therein.

[0110] In some embodiments, the attachment member has a display component thereon or attached thereto for guiding the surgeon to one or more labels. In some embodiments, the display component provides: i) a spatial orientation indicator (e.g., visual, auditory, etc.), and / or ii) a distance indicator to the label (e.g., visual, auditory, etc.). In some embodiments, the display component includes a first display (e.g., visual, auditory, light, color, vibration, tactile, etc.) for presenting distance information to the label; a second display (e.g., visual, auditory, light, color, vibration, tactile, etc.) for presenting vertical axis orientation (such as a preset preferred angle for approaching the label within the patient's body); and / or a third display for presenting horizontal orientation (e.g., left-to-right information that centers the surgical equipment as it approaches the label). In some embodiments, the display component includes multiple displays (e.g., visual, auditory, sensory, etc.) that allow for the use of correct pitch and yaw axes (to minimize damage to non-target tissues), and / or additional displays that provide distance information to the label. In some embodiments, the medical device moves around the patient's body prior to surgery to orient the transmitter and display components. In some embodiments, a series of lights and / or sounds are provided on the display components that guide the surgeon (e.g., the surgeon attempts to keep the light centered in an "X" series of lights, and / or keep the alarm sound volume off or as low as possible).

[0111] The link tags disclosed in this application are not limited to placement within specific body regions, body parts, organs, or tissues. For example, in some embodiments, the tags are placed in areas of the head, neck, chest, abdomen, pelvis, upper limbs, or lower limbs. In some embodiments, the tags are placed within organ systems such as the skeletal system, muscular system, cardiovascular system, digestive system, endocrine system, skin system, urinary system, lymphatic system, immune system, respiratory system, nervous system, or reproductive system. In some embodiments, the tags are placed within organs. Such organs may include the heart, lungs, blood vessels, ligaments, tendons, salivary glands, esophagus, stomach, liver, gallbladder, pancreas, intestines, rectum, anus, hypothalamus, pituitary gland, pineal gland, thyroid gland, parathyroid glands, adrenal glands, skin, hair, fat, nails, kidneys, ureters, bladder, urethra, pharynx, larynx, bronchi, diaphragm, brain, spinal cord, peripheral nervous system, ovaries, fallopian tubes, uterus, vagina, breasts, testes, vas deferens, seminal vesicles, and prostate. In some implementations, the tag is placed within tissues such as connective tissue, muscle tissue, nerve tissue, and epithelial tissue. Such tissues may include cardiac muscle tissue, skeletal muscle tissue, smooth muscle tissue, loose connective tissue, dense connective tissue, reticular connective tissue, adipose tissue, cartilage, bone, blood, fibrous connective tissue, elastic connective tissue, lymphatic connective tissue, reticular connective tissue, simple squamous epithelium, simple cuboidal epithelium, simple columnar epithelium, stratified epithelium, pseudostratified epithelium, and transitional epithelium.

[0112] In some embodiments, the tissue region where the tag is located includes the lesion. In some embodiments, the lesion is a tumor or a tissue region identified as being at risk of tumor formation. For example, one tag may be placed at the boundary of the tumor and another tag may be placed at a second boundary of the tumor, such that the link tags delineate the outer edge of the tumor. In some embodiments, the lesion is fibrotic tissue. In some embodiments, the lesion is an area of ​​inflammation or infection. In some embodiments, the tag is placed within an intraluminal space to detect organ function or other processes, or to provide location information. For example, the tag may be swallowed or placed in a hollow organ via endoscopy. In some embodiments, the tissue region is healthy tissue. In some embodiments, the two link tags are positioned away from the lesion. In some embodiments, the two link tags are positioned within the airway at a maximum of approximately 5 mm.

[0113] In some implementations, the link tag is placed within the solid tumor. Examples of solid tumors on which the tag can be placed include carcinomas, lymphomas, and malignant tumors, including but not limited to ectopic basal cell carcinoma, acinar cell carcinoma, acinar cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, adenoid / pseudoadenoid squamous cell carcinoma, uterine adnexal tumor, adrenocortical adenoma, adrenocortical carcinoma, amine precursor uptake and decarboxylation cell tumor, basal cell carcinoma, basaloid squamous cell carcinoma, carcinoid, cholangiocarcinoma, scarred basal cell carcinoma, clear cell adenocarcinoma, clear cell squamous cell carcinoma, complex small cell carcinoma, comedo carcinoma, complex epithelial carcinoma, cylindrical tumor, cystadenocarcinoma, cystadenoma, cystic basal cell carcinoma, Cystic tumors, ductal carcinoma, endometrioid tumors, epithelial tumors, extramammary Paget's disease, familial adenomatous polyposis, Pinkus fibroepithelial tumor, gastrinoma, glucagonoma, Graves' tumor, hepatocellular adenoma, hepatocellular carcinoma, sweat gland cystoma, Schulte's cell, invasive basal cell carcinoma, islet tumor, intraepithelial squamous cell carcinoma, invasive lobular carcinoma, inverted papilloma, keratoacanthoma, Klatskin tumor, Klukenberg's tumor, large cell keratinizing squamous cell carcinoma, large cell nonkeratinizing squamous cell carcinoma, leathery stomach, liposarcoma, lobular carcinoma, lymphoma Epithelial carcinoma, ductal carcinoma of the breast, medullary carcinoma, medullary breast carcinoma, medullary thyroid carcinoma, small nodular basal cell carcinoma, sclerosing basal cell carcinoma, morphological basal cell carcinoma, mucinous carcinoma, mucinous cystadenoma, mucinous cystadenoma, mucinous epidermoid carcinoma, multiple endocrine neoplasia, neuroendocrine tumors, nodular basal cell carcinoma, large eosinophilic tumor, osteosarcoma, ovarian serous cystadenoma, Paget's disease of the breast, pancreatic ductal carcinoma, pancreatic serous cystadenoma, papillary carcinoma, papillary hidradenoma, papillary serous cystadenoma, papillary squamous cell carcinoma, pigmented basal cell carcinoma, polypoid basal cell carcinoma Cancer, pitted basal cell carcinoma, prolactinoma, pseudomyxoma peritonei, renal cell carcinoma, renal eosinophilic tumor, erosive ulcer, serous carcinoma, serous cystadenocarcinoma, signet ring cell carcinoma, signet ring cell squamous cell carcinoma, skin appendage tumors, small cell carcinoma, small cell keratinizing squamous cell carcinoma, somatostatinoma, spindle cell squamous cell carcinoma, squamous cell carcinoma, squamous cell lung cancer, squamous cell thyroid carcinoma, superficial basal cell carcinoma, superficial multicentric basal cell carcinoma, papillary syringoma, syringoma, thymoma, transitional cell carcinoma, verrucous carcinoma, verrucous squamous cell carcinoma, vasodilator cystitoma, and Worcesteroma.

[0114] In some embodiments, placing the link tag includes the following steps: inserting an introduction device into the subject's body and introducing the link tag into the subject's body through the introduction device. In some embodiments, the introduction device is a needle, cannula, or endoscope. In some embodiments, the link tag is forced through the introduction device (e.g., by physical force, pressure, or any other suitable technique) and released into the subject's body at the distal end of the introduction device. After tag placement, the introduction device is removed, leaving the tag at the desired location on the subject. In some embodiments, the tag introduction is guided by imaging technology. In some embodiments, the link tag is moved to the desired location while being positioned within an encapsulation.

[0115] In the embodiments provided in this application, multiple tags are placed into the subject's body. The tags are linked together (e.g., via a linker). The tags may be of the same type or may be different (e.g., different signal types). The tags may be placed close to each other or at a distant location. In some embodiments, multiple tags are used to triangulate the location intended for a medical intervention.

[0116] In some implementations, the tag is further used as a reference for radiotherapy (or other targeted therapies). The tag's location is identified using an external reader and used to precisely place, for example, a laser on the skin surface where the chip is located. This eliminates the need for X-rays, CT scans, or fluoroscopy to view the reference. It also reduces or eliminates the need for skin markings (e.g., tattoos) on the patient. This also facilitates respiratory compensation as the reference moves up and down within a tumor in the lungs or abdomen. Therefore, real-time radiation can be administered only when the tumor is in the correct location, minimizing damage to background tissues (e.g., avoiding burning vertical strips within the patient as the tumor moves up and down). The use as a reference for guided therapies (e.g., radiotherapy) also enhances triangulation, as depth information (based on signal intensity) helps in tumor localization to minimize collateral damage.

[0117] In some embodiments, this application provides systems and methods employing one or more of the following: a) two or more linked tags (e.g., including antennas; e.g., coil antennas; e.g., ferrite core coil antennas; e.g., antennas resonating at 100kHz-200kHz; e.g., antennas coupled to an integrated circuit); b) a remote activation device that generates a magnetic field within the tag's area; and c) a plurality of sensors (e.g., measurement reference stations), each of which includes an antenna configured to detect information generated by the tag or a change in the magnetic field generated by the remote activation device caused by the tag. In some embodiments, at least one of the linked tags transmits sidebands at a set frequency when activated by the magnetic field, and the measurement reference stations detect such sidebands. In some embodiments, at least one of the linked tags transmits sidebands at a frequency set by a number programmed into a counter within the tag.

[0118] In some embodiments, the remote activation device includes an excitation coil, which is powered, for example, by a generator electrically connected to the remote activation device. In some embodiments, the remote activation device includes a pad configured to be placed close to a patient (e.g., below, above, or beside), the patient having a link tag embedded in the patient's body. In some embodiments, the pad also includes a measurement reference station.

[0119] In certain embodiments, this application provides devices and systems comprising: a remotely activated device for generating magnetic flux within a region of a tag, wherein the remotely activated device includes: a) a bottom substrate, b) at least one excitation coil for generating magnetic flux attached to the bottom substrate, and c) a plurality of measurement reference station assemblies attached to the bottom substrate, wherein each of the measurement reference station assemblies includes a measurement reference coil having a sensing axis and including: i) a core having a coilless proximal end, a coilless distal end, and a central region, wherein the core comprises metal, and ii) a coil winding wound around the central region of the core, wherein each of the measurement reference station assemblies is oriented on the bottom substrate such that the sensing axis of each of the measurement reference coils: A) extends from the proximal end to the distal end of the core, and B) is orthogonal to or substantially orthogonal to: i) the magnetic flux, and / or ii) at least one excitation coil. In a particular embodiment, at least one excitation coil is configured to selectively allow current to flow in a clockwise or counterclockwise direction. In other embodiments, the sensing axis of each excitation coil in the excitation coil is substantially orthogonal to both the clockwise and counterclockwise magnetic flux.

[0120] In some embodiments, each excitation coil in the excitation coil includes a central plane, and each measurement reference station assembly in the measurement reference station assembly is further oriented on the bottom substrate such that the sensing axis: C) of each measurement reference coil in the measurement reference coil is coplanar with the central plane of each excitation coil in the excitation coil. In a particular embodiment, magnetic flux is not induced in the measurement reference coil when it is generated substantially along the X and / or Y directions.

[0121] In other embodiments, each measurement reference station assembly further includes: i) a first measurement reference coil support and a second measurement reference coil support, and ii) a first elastomer portion and a second elastomer portion, wherein the coilless proximal end of the core is fixed between the first measurement reference coil support and the first elastomer portion, and the coilless distal end of the core is fixed between the second measurement reference coil support and the second elastomer portion. In another embodiment, the first measurement reference coil support and the second measurement reference coil support each include at least one adjustment portion. In other embodiments, at least one adjustment portion includes at least one screw and / or at least one rod. In a particular embodiment, this application provides a method of using adjustment portions to adjust measurement reference coils such that their sensing axes are orthogonal to or substantially orthogonal to the magnetic flux and / or at least one excitation coil.

[0122] In some embodiments, at least one adjustment portion allows adjustment of the sensing axis of each measurement reference coil in the measurement reference coils such that it is orthogonal to or substantially orthogonal to the magnetic flux in one or more of the X, Y, or Z directions. In some embodiments, the sensing axis of each measurement reference coil in the measurement reference coils can be adjusted such that it is orthogonal to both the X and Y directions. In another embodiment, the magnetic flux can be further selectively generated along substantially the Z direction, and each measurement reference station assembly in the measurement reference station assembly is oriented on the bottom substrate such that the sensing axis of each measurement reference coil in the measurement reference coils is orthogonal to or substantially orthogonal to the magnetic flux in the Z direction. In another embodiment, the magnetic flux, when generated along substantially the Z direction, does not induce a signal in the measurement reference coils. In another embodiment, at least one adjustment portion allows adjustment of the sensing axis of each measurement reference coil in the measurement reference coils such that it is orthogonal to or substantially orthogonal to the magnetic flux in each of the X, Y, and Z directions. In some embodiments, the metal comprises ferrite.

[0123] In other embodiments, each measurement reference station assembly is oriented on the bottom substrate such that the sensing axis of each measurement reference coil is orthogonal to or substantially orthogonal to at least one excitation coil. For example, each measurement reference station assembly may be oriented on the bottom substrate such that the sensing axis is orthogonal to or substantially orthogonal to at least two, three, or four excitation coils. In some embodiments, each measurement reference station assembly is oriented on the bottom substrate such that the sensing axis of each measurement reference coil is orthogonal to or substantially orthogonal to the magnetic flux in each of the X and Y directions. In other embodiments, the four or more excitation coils are four or six excitation coils. In other embodiments, the four excitation coils are arranged in two rows centered at coordinates (X1, Y1), (X1, Y2), (X2, Y1), and (X2, Y2). In an additional implementation, the remote activation device includes three current flow configurations: a) all current flows clockwise to simulate an excitation coil aligned or substantially aligned with a plane orthogonal to the Z-axis; b) an excitation coil centered at (X2,Y1), (X2,Y2) allows current to flow counterclockwise to simulate an excitation coil aligned or substantially aligned with the X-axis; and c) an excitation coil centered at (X1,Y2), (X2,Y2) allows current to flow counterclockwise to simulate an excitation coil aligned or substantially aligned with the Y-axis.

[0124] In some embodiments, the sensing axes of the measurement reference coil are substantially orthogonal when the isolation between at least four excitation coils and the measurement reference coil is 60 dB or greater in the X and Y directions. In other embodiments, the sensing axes of the measurement reference coil are substantially orthogonal when the isolation between at least four excitation coils and the measurement reference coil is 60 dB or greater in the X, Y, and Z directions.

[0125] In some embodiments, this application provides systems and apparatuses including: an excitation assembly that cycles through generating at least a first magnetic field, a second magnetic field, and a third magnetic field (e.g., a first magnetic field, a second magnetic field, a third magnetic field, a fourth magnetic field, a fifth magnetic field, a sixth magnetic field, a seventh magnetic field, and / or an eighth magnetic field) to cause a tag to generate a signal, wherein the excitation assembly includes A) a bottom substrate, B) a first excitation coil attached to the bottom substrate, wherein current in the first excitation coil travels clockwise when generating the first, second, and third magnetic fields. In some embodiments, the exciter further includes C) a second excitation coil attached to the bottom substrate, wherein current in the second excitation coil travels clockwise when generating the first and second magnetic fields, and counterclockwise when generating the third magnetic field. In some embodiments, the excitation assembly further includes D) a third excitation coil attached to the bottom substrate, wherein current in the third excitation coil travels clockwise when generating the first and third magnetic fields, and counterclockwise when generating the second magnetic field. In some embodiments, the excitation assembly further includes a fourth exciter attached to the bottom substrate, wherein the current in the fourth excitation coil travels clockwise when generating the first magnetic field and counterclockwise when generating the second and third magnetic fields.

[0126] For example, excitation coils can be wound with Litz wire to minimize resistive losses due to the skin effect that occurs as frequency increases. The number of turns is typically chosen to maximize the coil's "Q" (inductance-to-resistance ratio). An exemplary coil example consists of 63 turns of Litz wire, made of 100 strands of 38AWG wire. The inductance of a single coil is measured to be approximately 1.1 mH, and the Q (inductance-to-resistance ratio) is measured to be over 500 at 134.5 kHz. Other coil constructions can be made using other wires with different inductance and Q values. However, it is generally desirable to keep the "Q" as high as possible to minimize resistive losses that lead to efficiency losses and greater heat generation.

[0127] In some embodiments, this application provides systems and apparatus comprising: a) a bottom substrate; b) a first excitation coil attached to the substrate and configured to generate a magnetic field for causing a tag to generate a signal; and c) a balun circuit electrically linked to the first excitation coil. In some embodiments, these systems and apparatus further include a second excitation coil attached to the substrate and configured to generate a magnetic field for causing a tag to generate a signal, and c) the balun circuit electrically linked to the second excitation coil. In some embodiments, these systems and apparatus further include a third excitation coil, or a third and fourth excitation coil, attached to the substrate and configured to generate a magnetic field for causing a tag to generate a signal, and c) the balun circuit electrically linked to the third or fourth excitation coil.

[0128] In certain embodiments, each of the second excitation coil, the second excitation coil and the third excitation coil, or the second excitation coil, the third excitation coil and the fourth excitation coil, is operatively connected to a switch that controls the direction of current through the coil. In some embodiments, each switch includes a relay element, a PIN diode, a field-effect transistor, or other solid-state switching device. In certain embodiments, each switch additionally switches at least one capacitor (e.g., two capacitors) into the circuit to maintain a constant resonant frequency of the series combination of excitation coils, regardless of changes in the total coil inductance caused by changes in coil polarity.

[0129] The inductance of an exemplary excitation coil system is measured to be 1.1 mH, where Q > 500 for each individual coil. Due to the interaction of the magnetic flux generated by each coil, coils such as a series combination of four coils (e.g., as...) Figure 4A The inductance (shown) varies with the polarity of the coil (current direction). The inductance of the series combination of all four exemplary coils is measured to be 3.9 mH, where for Figure 5 The current direction depicted is Q = 435, where all coils have current flowing in a clockwise direction. For Figure 6 The current direction is depicted in the figure. The inductance of the series combination of all four exemplary coils is measured to be 4.6 mH, where Q = 500, and coils A and B have current flowing in a clockwise direction, while coils C and D have current flowing in a counterclockwise direction. For Figure 7The current direction is depicted in the figure. The inductance of the series combination of all four exemplary coils is measured to be 4.3 mH, where Q = 473. Coils A and C have current flowing in a clockwise direction, and coils B and D have current flowing in a counterclockwise direction. This change in total inductance when the coil polarity changes requires switching appropriate compensation capacitors.

[0130] In some implementations, the components of a relay or switch and the associated capacitor may be placed on a ceramic substrate to provide a secure mount, excellent dielectric properties, and also serve as a heat sink to reduce localized heating of individual components.

[0131] In some embodiments, these systems and devices further include a plurality of measurement reference coils or measurement reference station assemblies attached to a substrate and configured to detect signals from the tag. In some embodiments, the measurement reference coils are positioned such that the axis of the coil is coplanar with the central plane of the excitation coil. In this plane, for each combination of coil current directions described previously, the magnetic flux generated by the exciter is orthogonal to the sensing axis of the measurement reference coil. The orthogonal excitation current does not induce a signal in the measurement reference coil, and thus provides isolation between the excitation coil and the measurement reference coil. This isolation is typically required to achieve the desired system dynamic range, enabling the detection of very weak tag signals even in the presence of a very large exciter magnetic field. This isolation is also important because crosstalk between the excitation coil and the measurement reference coil would otherwise significantly impede navigation, as crosstalk terms would attribute important signals generated by the same magnetic dipole (exciter) to all measurement reference coils, and thus the measurement reference coils would lose their spatial independence. An additional point is that the presence of a z-oriented exciter significantly distorts the z-component of the tag (and transmitter) magnetic field, making it less useful for navigation.

[0132] In another embodiment, the plurality of measurement reference coils or the plurality of measurement reference station assemblies comprise six to thirty measurement reference coils (e.g., 6…9…12…20…or 30). In an additional embodiment, the plurality of measurement reference coils: i) are located on opposite sides of the bottom substrate, but not adjacent to the opposite sides, and / or ii) are each positioned in alternating opposite orientations relative to the other measurement reference coils along the x-axis and y-axis. This positioning minimizes crosstalk between the measurement reference coils, thereby reducing the extent to which crosstalk compensation is applied (e.g., via mathematical solver software).

[0133] In some embodiments, these systems and devices also include multiple printed circuit boards, wherein each of the multiple measurement reference coils is operatively linked to one of the multiple circuit boards. In some embodiments, each circuit board includes at least two capacitors and at least one balun circuit. In particular embodiments, these systems and devices also include link tags.

[0134] In some embodiments, these systems and devices further include a balun circuit electrically linked to each of at least one excitation coil. In other embodiments, these systems and devices further include a cable bundle electrically linked to the balun circuit. In yet another embodiment, these systems and devices further include a plurality of measurement reference coils attached to a substrate and configured to detect signals from a link tag, wherein the plurality of measurement reference coils are electrically linked to the cable bundle.

[0135] In some embodiments, these systems and devices further include at least one self-test transmitter. In other embodiments, these systems and methods further include a top cover, wherein the top cover mates with a bottom substrate to encapsulate each excitation coil among the excitation coils therein.

[0136] In other embodiments, these systems and devices further include a system electronic housing configured to provide signals to the excitation coils. In other embodiments, the centers of each excitation coil are separated from each other by at least 5 cm (e.g., 5cm…10cm…15cm…25cm…100cm…1000cm). In other embodiments, the distance between the centers of each excitation coil is 2 to 5 times the maximum size of the coil itself. In some embodiments, a fourth excitation coil is positioned adjacent to a second excitation coil, and a third excitation coil is positioned adjacent to a first excitation coil and diagonally opposite to the second excitation coil.

[0137] In some embodiments, this application provides methods comprising: a) positioning the system or device disclosed herein below or near a patient in which at least two link tags are positioned, and b) activating the system or device to generate a magnetic field, thereby causing each link tag to generate a signal.

[0138] In some embodiments, this application provides systems and devices including a measurement reference station assembly, wherein the measurement reference station assembly includes: a) a measurement reference coil, wherein the measurement reference coil includes: i) a metal core having a coilless proximal end, a coilless distal end, and a central region, and ii) a coil winding wound around the central region of the metal core; b) a first measurement reference coil support and a second measurement reference coil support; and c) a first elastomer portion and a second elastomer portion, wherein the coilless proximal end of the metal core is fixed between the first measurement reference coil support and the first elastomer portion, and wherein the coilless distal end of the metal core is fixed between the second measurement reference coil support and the second elastomer portion. In some embodiments, these systems or devices further include a remote activation device (e.g., as described in this application), wherein the remote activation device includes at least one excitation coil. In other embodiments, these systems and devices further include an excitation assembly (e.g., as described in this application), wherein the excitation assembly includes at least one excitation coil.

[0139] In another embodiment, the first and second measurement reference coil supports each include at least one adjusting portion (e.g., two adjusting screws). In some embodiments, at least one adjusting portion includes at least one screw and / or at least one lever. In other embodiments, the measurement reference station assembly also includes electronic components electrically linked to the measurement reference coil. In other embodiments, the electronic components include at least one capacitor and / or at least one balun circuit. In yet another embodiment, the electronic components include a printed circuit board.

[0140] In some embodiments, the measurement reference station assembly further includes a Faraday barrier. In other embodiments, the measurement reference station assembly further includes: i) electronic components electrically linked to the measurement reference coil, and ii) a Faraday barrier. In an additional embodiment, the first elastomer portion and the second elastomer portion comprise materials selected from elastomeric polymers and springs.

[0141] In some embodiments, the metal core comprises a ferrite core. In other embodiments, the diameter of the metal core is 4 mm to 25 mm (4 mm…8 mm…12 mm…14 mm…16 mm…25 mm). In some embodiments, the length of the metal core is 15 mm to 75 mm (e.g., 15 mm…30 mm…45 mm…58 mm…75 mm). In a particular embodiment, the coil winding comprises metal wire. In other embodiments, the metal wire is wound around the metal core 150 to 300 times. In yet another embodiment, the first and second measuring reference coil supports each include a slot configured to mate with the wireless proximal end and / or wireless distal end of the metal core.

[0142] In certain embodiments, this application provides devices and systems comprising: a) an attachment member (e.g., a sheath) configured to attach to a handheld medical device having a device tip, wherein the attachment member includes: i) a proximal end, ii) an angled distal end, wherein the angled distal end includes a distal end opening configured to allow the device tip, but not the remainder of the medical device, to pass through therethrough; and iii) a body stretched between the proximal end and the angled distal end; and b) a first positioning transmitter and a second positioning transmitter attached to the attachment member.

[0143] In some embodiments, the angled distal end has an angle of at least 35 degrees relative to the longitudinal axis of the attachment member (e.g., at least 35 degrees…45 degrees…65 degrees…85 degrees…or 95 degrees). In some embodiments, the angled distal end has an angle of approximately 90 degrees relative to the longitudinal axis of the attachment member. In other embodiments, the first positioning transmitter and the second positioning transmitter are attached to the body of the attachment member (e.g., spaced apart).

[0144] In other embodiments, these systems and devices further include: c) a display component housing, wherein the display component housing is attached to or can be attached to the proximal end of the attachment component. In additional embodiments, these systems and devices further include a display component attached to the display component housing, wherein the display component includes a display screen (e.g., an LCD screen) for displaying the positioning of an implanted tag in the patient's body relative to a device tip on a medical device. In other embodiments, the display component housing includes a cable management component. In additional embodiments, the display component housing includes a housing tapered connector. In yet another embodiment, the proximal end of the attachment component includes a proximal tapered connector.

[0145] In other embodiments, these devices and systems further include a first positioning transmitter lead wire and a second positioning transmitter lead wire, wherein the first positioning transmitter lead wire is electrically linked to a first positioning transmitter (e.g., a small coil), and the second positioning transmitter lead wire is electrically linked to a second positioning transmitter (e.g., a small coil). In other embodiments, these systems and devices further include: c) an adhesive strip whose size and shape are configured to cover at least 50% (e.g., 50%...75%...90%) of the attachment component body and configured to adhere the attachment component to a medical device. In some embodiments, these systems and devices further include: c) a medical device. In other embodiments, the medical device includes an electrocautery surgical device.

[0146] A. Handling the variable alignment of the external coil (e.g., the tag coil) with the excitation assembly.

[0147] In some embodiments, the exciter is configured to supply power to the tag regardless of the alignment of the tag's coil with the exciter. For example, in some embodiments, power transfer to the tag may depend on the relative orientation of the exciter's magnetic field with the tag. In some such embodiments, without corrective measures, the tag may only collect power from the field portion aligned with the tag's coil (e.g., a ferrite core coil contained within the tag). This problem can be addressed by including multiple exciters capable of generating magnetic fields in all three orthogonal directions. However, this results in thicker components and both a repulsion (see section B below) preventing coupling between the primary excitation coil (e.g., located in the excitation assembly) and the sensing coil (also located in the excitation assembly) and a repulsion for secondary field coupling between the tag / transmitter and the excitation coil, which subsequently couples to the sensing coil and impairs the positioning of the tag or transmitter (see section C below). To address this challenge, this application provides configurations of excitation assemblies that provide a mechanism for altering the orientation of the magnetic field, wherein the excitation coil may be deployed along only one magnetic direction.

[0148] In some implementations, this is achieved by having multiple coils in the excitation assembly (see, for example, Figure 4A And set the current direction in each coil to clockwise or counterclockwise (see, for example, Figures 5-7 This is achieved through [the following method / method]. In some implementations, the coils are connected in series so that the same current flows in each coil. In some implementations, the coil layout includes four coils arranged in two rows, centered at coordinates (X1,Y1), (X1,Y2), (X2,Y1), and (X2,Y2), with three sets of current flow configurations: Configuration 1: all current flows clockwise to simulate an excitation coil aligned with a plane orthogonal to the Z-axis; Configuration 2: the coil centered at (X2,Y1), (X2,Y2) allows current to flow counterclockwise to simulate an excitation coil aligned with the X-axis; and Configuration 3: the coil centered at (X1,Y2), (X2,Y2) allows current to flow counterclockwise to simulate an excitation coil aligned with the Y-axis. Any number of other coil configurations can be used. For high efficiency, it is desirable (though not necessary) to minimize the number of components and the overall complexity of the design. However, in some implementations, it may be desirable to have more than four coils in the excitation assembly (e.g., 6, 8, 10, 16, etc.) to provide greater flexibility to change the directionality of the magnetic field, although this comes at the cost of system complexity.

[0149] When the same current flows through all the coils in each configuration, fewer configuration variations are needed to tune the coils in the excitation assembly for each configuration. This is because the effect of one excitation coil on other excitation coils depends on the state of the first excitation coil (open circuit, current-carrying, etc.).

[0150] To provide optimal performance, the area of ​​the excitation coils should be maximized, and the distance between the centers of the coils should also be maximized. For the same applied current, a larger coil area provides a higher field. For configurations 2 and 3, coils with a greater separation distance provide greater directional variation.

[0151] Figure 3 Exemplary schematic diagrams of a four-coil excitation assembly in some embodiments of the present invention are provided, wherein the four coils are labeled as coil A, coil B, coil C, and coil D (see [reference]). Figure 4A ).

[0152] For medical applications, where the excitation assembly is provided below the patient in a flat planar configuration (e.g., a pad), the clinically preferred system geometry requires all four coils to be placed very close to each other. Therefore, the magnetic coupling between each coil varies with the individual coil polarity, and thus the total inductance of all four coils in series varies with the coil polarity combination. Therefore, optimal performance must necessarily balance these competing factors. To compensate for this, in some embodiments, a switching system is employed where an additional series capacitor reactance is inserted as the total inductance increases, such that the tuning center frequency remains at the desired excitation frequency. Figure 3 In the preferred embodiment shown, a relay is used for switching. Other embodiments may employ solid-state switching methods, such as PIN diodes. Any suitable mechanism can be used to achieve the switching.

[0153] In some embodiments, the centers of the coils are spaced 10cm…50cm…100cm…500cm or 1000cm apart. In some embodiments, the area of ​​each coil is 25cm². 2 ……625cm 2 ……2500cm 2 ……62,500cm 2 ...or 250,000cm 2 When all four coils have the same polarity, the maximum total series capacitance is required. In some implementations, this series capacitance is evenly distributed across all four coils, such as... Figure 3 The capacitance is balanced on each side of the switching relay as shown. Distributing the capacitance in this way minimizes the contact voltage present at the switch. Otherwise, a high "Q" in the coil could lead to excessively high voltages at the switch and interconnects, exceeding 10 kV in some configurations.

[0154] The additional capacitance used to maintain the desired resonant frequency as described above (e.g., adding a series capacitor to reduce capacitance) is switched by a polarity-switching relay or a separate switch that can be energized when needed. In some embodiments, the capacitance is distributed between the polarity-switching relays to minimize terminal voltage and common-mode coupling by achieving optimal symmetry.

[0155] In some implementations, each capacitive element consists of multiple capacitors to minimize the voltage across each capacitor to ensure that it does not exceed the voltage capability of the capacitor and to minimize heating due to losses that could otherwise cause the resonant frequency to drift.

[0156] In some implementations, the balun is incorporated as close as possible to the excitation coil (see section D below). Figure 3 The balun described below achieves common-mode rejection to reduce or eliminate electric field generation and also provides impedance transformation to optimally match the impedance of the coil assembly with the impedance of the transmission line and power amplifier. In some implementations, the primary side (amplifier side) of the balun has 8 turns and the secondary side (coil side) has 4 turns, thus providing a 4:1 impedance change, which makes, for example, a 50-ohm generator output impedance very well matched to the 12-ohm coil impedance at resonance. Other turns ratios can be used to achieve optimal impedance transformation to transmission lines and amplifiers with other characteristic impedances.

[0157] Figure 3 An exemplary implementation of a coil system used in an excitation assembly is provided. In this figure, multiple capacitors are represented by numbers (e.g., C1, C5, C11, C40, etc.; pF (picofarads)) and their relative to coils A, B, C, and D (see, e.g., Figure 4A The relative position identification of the transformer is shown. A 7:4 turns ratio balun is illustrated (the balun ratio matches the impedance to 50 ohms using a 7:4 ratio, with 7 turns on the 50-ohm side and 4 turns on the coil side). This system can be configured or tuned to optimize performance based on the utilization of the coils. For example, as... Figure 3 An exemplary implementation is shown:

[0158] Field: Z-plane (++++) capacitors C9 and C10 are 25,600pF (20,000pF in parallel with 5,600pF);

[0159] Field: X-plane (+-+-) capacitors C19 and C20 are 27,235pF (using a series combination of 27,000pF and (2) 470pF capacitors in parallel);

[0160] Field: Y-plane (++--) capacitors C29 and C30 are 6,050pF (2,700pF and 3,300pF in parallel and (2) 100pF capacitors in series in parallel);

[0161] General purpose (all fields): Capacitors C39 and C40 are 9,000pF ((3) parallel combination of 3,000pF capacitors); and

[0162] The C39 and C40 capacitors (with fixed values ​​X and Y) are 9,000pF (18,000pF in series with 18,000pF; or 9,220pF; 8,200pF in parallel with 820pF or other combinations; total voltage is 660Vrms).

[0163] Other specific capacitance values ​​can be used to provide the desired resonant frequency or frequencies with different inductance values ​​that may be generated by different coil constructions.

[0164] B. Processing the exciter field strength near the sensor

[0165] Generally, the field strength of the exciter used to power the tag is close to that of the exciter, in order to form a large volume capable of powering one or more tags. This field is much larger than that provided by one or more tags or a transmitter associated with a surgical instrument (tags and transmitters are collectively referred to in this application and individually as "beacons"). Moreover, since a single excitation component device is preferred to provide both excitation and sensing, the sensing component should be located close to the exciter component. Therefore, magnetic field sensors typically sense the magnetic field at a very large excitation frequency, approximately 160 dB or greater than the excitation frequency of the signal of interest (from the beacon).

[0166] This problem can be partially solved with electronic filters. However, these filters have limited rejection capabilities, are expensive, and bulky. Filters can be active or passive. However, active electronic filters have an inherent noise floor that limits dynamic range and filtering effectiveness for such high dynamic range conditions; therefore, passive filters may be used in some implementations.

[0167] Alternative (or additional) solutions utilize the coil system described in section A above. In such implementations, the exciter field pickup of the sensor can be reduced by utilizing the vector nature of the magnetic field. In some implementations, an exciter coil with an orientation that generates only magnetic flux and is substantially perpendicular to the XY plane containing the sensing coil is selected. In some implementations, a ferrite core coil, which is also inherently highly directional, is then aligned with this plane such that magnetic flux orthogonal to this plane is not sensed. This produces an exciter field repulsion of more than 40 dB. In preferred geometries, an isolation greater than 70 dB has been achieved for all sensing coils in all three polarity configurations described above. The height and tilt of each measurement reference coil are adjusted to achieve the alignment required to achieve this level of isolation for all three coil polarity conditions. The isolation is typically measured using a vector network analyzer by connecting the exciter coil to port 1 and the specific measurement reference coil to port 2. S is then measured at the receiving frequency. 21 The size and phase. In a preferred embodiment, the selected receiving frequency is 130.2 kHz.

[0168] In such implementations, the system therefore uses one magnetic field direction for excitation and the two remaining directions (orthogonal to the excitation direction) for sensing. In other implementations, two orthogonalities may be used for excitation and one orthogonality for sensing. However, it may be preferable to use two orthogonalities for sensing to provide a faster estimate of the beacon's position.

[0169] C. Handling exciter / beacon coupling

[0170] In some implementations, the exciter is a highly resonant coil. Because in some implementations the beacon's frequency is close to the exciter's resonant frequency, a portion of the beacon's AC magnetic field aligned with the exciter coil's orientation can induce current flow in the exciter and thus generate a magnetic field at the beacon's frequency within the exciter coil's orientation. This effect distorts the original field from the beacon, making beacon positioning more difficult. In clinically preferred geometries, this distortion obscures the beacon's true positioning, making navigation potentially difficult or impossible.

[0171] This coupling can be reduced by selecting different beacon frequencies that are not too close to the exciter resonance. However, since in some preferred embodiments the beacon uses a single ferrite core RF coil for both reception and transmission, the available bandwidth is limited.

[0172] Conversely, using the exciter configuration described in sections A and B above, the tortuous field is not sensed because the sensing system, composed of sensing coils, is orthogonal to the exciter coil orientation. In other words, the tortuosity is confined to a magnetic field direction substantially aligned with the exciter coil and orthogonal to the sensing system. Therefore, the beacon's true positioning is no longer masked by the field distortion generated by the exciter current flowing at the beacon frequency, thus enabling accurate navigation without artifacts.

[0173] D. Handling the magnitude of the electric field generated by the system

[0174] The exciter and associated circuitry should be designed to minimize the magnitude of the electric field generated by the system. If generated, the electric field can capacitively couple into the sensing system and reduce system accuracy. Furthermore, the interaction between the electric field and the patient and environment is more significant than that between the magnetic field and the system.

[0175] In some implementations, this challenge is addressed by incorporating a balun as close as possible to the excitation coil. A balun, which can also act as an impedance transformer, minimizes the electric field by eliminating asymmetrical currents relative to ground. Another way to think about this is that the balun eliminates common-mode coupling. In some implementations, the circuit design and layout on the excitation side of the balun should be as symmetrical as possible to maintain balance.

[0176] In addition to reducing electric field effects, the transformer allows the use of readily available 50-ohm coaxial transmission lines without mismatch. This proportionally regulates the transmission line voltage and current to optimally deliver power to the excitation components with the best efficiency and the smallest, most flexible coaxial cable.

[0177] E. Identifying and managing the location of multiple beacons

[0178] According to the method described in this application, two or more beacons (e.g., tags, transmitters associated with one or more surgical devices, or other objects for which localization, location, relative location, or other spatial information is desired) are employed. The two or more beacons (e.g., tags) are linked together by a linker (e.g., “linked tags”). In some embodiments, each beacon generates the same frequency. Such embodiments may be advantageous because the signal strength can be up to twice as great as using a single beacon (assuming two tags are used, three times greater if three tags are used, four times greater if four tags are used, and so on). Therefore, such embodiments can be used with larger patients whose tissue volume would otherwise limit the ability to detect signals from a single beacon.

[0179] In some implementations, each beacon generates the same frequency and the two signals can be deconvolved to improve overall detection accuracy. In some implementations, the tags are programmed to respond with an offset frequency compared to the stimulus frequency. In some implementations, the tags are programmed to respond with an offset frequency and a stable phase locked to the stimulus signal. This strategy allows the response signal to be easily decoupled from the stimulus signal. In particular, locking to the stable phase of the stimulus signal allows for precise localization of the signal from each of at least two linked tags. In some implementations, each of two or more tags generates the same frequency but is programmed to have a set phase offset. In some implementations, each beacon generates the same frequency, but the phase of each beacon can be a random factor of 11.25 degrees, which can be used to deconvolve the two signals.

[0180] In some implementations, each distinct beacon (e.g., a tag) generates a unique frequency, spectrum, or other distinguishable signal. In some such implementations, a containment algorithm is employed to identify spatial information for one or more beacons. In some implementations, optimal exciter polarity and power levels (e.g., taking into account any relative orientation of the beacon to the exciter) are identified for each beacon by cycling the exciter through different planes. Based on this information, an optimal exciter mode is calculated to maximize protocol quality and the accuracy of the information conveyed to the user (e.g., a physician). In some such implementations, a first optimal mode is used to provide spatial information about a first tag and to perform the first part of the protocol. Next, a second optimal mode (which may be the same or different) is used to provide spatial information about a second tag and to perform the second part of the protocol. Additional cycling may be performed for additional tags. Alternatively, the exciter mode (polarity and power) may cycle between multiple different optimal modes during the protocol to provide near-real-time optimal spatial information for multiple beacons. In some such implementations, rapid switching of coil polarity in the transmitter is employed to power two or more beacons simultaneously or nearly simultaneously.

[0181] F. Exemplary Protocol

[0182] This technology is not limited by the tag placement method and considers a wide range of placement techniques, including but not limited to open surgery, laparoscopy, endoscopy, and transvascular catheterization. Tags can be placed using any suitable device, including but not limited to syringes, endoscopes, bronchoscopes, extended bronchoscopes, laparoscopes, and thoracoscopes. An exemplary protocol is provided below.

[0183] Patients previously identified as having breast tumors are admitted to the medical facility. They are initially referred to the radiology department. Radiologists review previous imaging information that identified the target tumor. A local anesthetic, typically lidocaine or a derivative, is administered to the subject using a percutaneous needle. The subject is positioned in an imaging device, typically ultrasound, conventional mammography, or a stereotactic unit. The tumor is located. An introduction needle (usually 6-20 gauge) is inserted into or adjacent to the tumor, and a biopsy needle is placed through the introduction needle. Samples are obtained using various methods (aspiration, mechanical cutting, cryotherapy to fix the tissue position followed by mechanical cutting). After obtaining the sample and sending it for pathological examination, a 6-20 gauge tagged delivery needle is inserted into the coaxial introduction needle until it reaches the tissue, with the distal opening positioned at the lesion. Two linked tags are inserted into the proximal end of the delivery needle and delivered into the tissue by a plunger through an opening at the distal end of the needle. Again, the tags may have been pre-positioned at the distal end of the delivery needle. Imaging confirms the proper positioning of the linked tags. The delivery needle is withdrawn, leaving the tag in the appropriate position within the breast tissue.

[0184] This type of procedure can be performed in a similar manner in virtually any body space, organ, or pathological tissue, with the aim of locating that tissue or space for any kind of further diagnosis or treatment. Areas of particular interest include, but are not limited to, the following organs and the disease processes occurring within them: brain, skull, head and neck, thoracic cavity, lungs, heart, blood vessels, gastrointestinal structures, liver, spleen, pancreas, kidneys, retroperitoneum, lymph nodes, pelvis, bladder, genitourinary system, uterus, ovaries, and nerves.

[0185] In some implementations, during the procedure, the patient is placed on an operating table, the surgical area is exposed and disinfected. Imaging information showing the location of the target tissue (e.g., a tumor) and the label is provided to the surgeon. An incision is made at the location of the needle entry point. A remote activation device is placed close to the tissue to activate the label. A measurement reference station (e.g., such as...) is included. Figure 4A The detection component (shown) detects signals from the tag and allows the surgeon to guide the medical device toward the tumor. Once the tumor is located, the surgeon removes the appropriate tissue and optionally removes the tag.

[0186] In some implementations, the system is used during surgery where a tag is placed on or inside the body as a reference. Electromagnetic fields are used to locate the relative position of the tag and any surgical instruments. This information is transmitted to the physician in real time using a variety of methods, including but not limited to visual (computer screen, orientation and depth indicators using various methods, haptic feedback, audio feedback, holograms, etc.) and the position of the instruments displayed in 2D or 3D on any medical image (such as CT, MRI, or PET scans). This data discovery is used to guide the physician during procedures or as a training method so that the physician can perform virtual procedures. Such systems can be integrated into existing surgical systems or provide alternative methods to existing surgical systems, such as the STEALTH system (Medtronic) for applications such as neurosurgery.

[0187] In some embodiments, information about the location of a label or the surgical path or route to the label is communicated to a surgeon or other user in a manner that includes one or more augmented reality or virtual reality components. For example, in some embodiments, the surgeon wears or accesses a virtual reality device (e.g., goggles, glasses, helmet, etc.) that displays a partial or complete virtual image of the patient or surgical situation. Label location information collected and calculated by the system described in this application is represented to the surgeon by one or more visual components to aid in accurate targeting of one or more labels. For example, tissue containing a linked label can be represented by a virtual image showing the label's location. Similarly, in some embodiments, the surgical path is visually presented as, for example, a colored line to be followed. In some embodiments employing augmented reality features, the display presents a graphical or video capture of the patient representing what the surgeon would visualize in the absence of a monitor, and one or more augmented features are overlaid on the display. The graphical or video display data may be captured by one or more cameras in the surgical field. Augmented features include, but are not limited to, representations of label location in target tissue, projected surgical paths, target points where the surgeon aligns the tip of a surgical instrument, simulated surgical margins to be treated, arrows or other positioning indicators recommending movement if the optimal path deviates from it, etc.

[0188] Exemplary excitation assembly 250 is shown in Figure 4. Figure 5 , Figure 6 and Figure 7 As shown in the image. Figure 1 As shown, the excitation assembly can be positioned under the mattress of a patient lying on a surface, such as an operating table or mattress. The exemplary excitation assembly in these figures provides excitation signals to a tag inside the patient's body via four excitation coils 150. Figure 4AAn exemplary excitation assembly provides multiple measurement reference coil assemblies (also referred to as measurement reference station assemblies) 161, each having a measurement reference coil 160 for detecting signals from the implanted tag and the tag in the attachment part of the surgical device. The excitation assembly comprises a bottom substrate 140, to which other components are typically attached or integrated. The bottom substrate is made of any suitable material, which may be, for example, polycarbonate and is generally nonmagnetic and non-conductive. Figure 4A The top cover 230 is not depicted in the text (see also). Figure 8 The top cover mates with the bottom substrate to enclose all internal components. The top cover can be made of any suitable material, including Kevlar and / or other rigid materials, which are generally non-magnetic and non-conductive. Foam or other types of fillers may be included on top of the top cover.

[0189] Attached to the bottom base plate are four large excitation coils 150. Figure 4A The coils are labeled "Coil A", "Coil B", "Coil C", and "Coil D". Each excitation coil 150 may be wound around four excitation coil mounts 155. In some embodiments, the excitation coils are not wound in any particular form, but rather use wires that are integrated with themselves to form a coil shape. Although in Figure 4A Not shown, but in some embodiments, coil covers (e.g., plastic coil covers) are located above each of the four excitation coils. Between the typically centered four excitation coils is a large center-balanced-unbalanced converter circuit 180.

[0190] Inside the excitation coils B, C, and D is switch 190. Switch 190 contains components such as relays or multiple PIN diodes (e.g., at least four PIN diodes) or field-effect transistors, which control the directionality (clockwise or counterclockwise) of the current in the respective excitation coil. Figure 4AIn a particular implementation, excitation coil A does not have a switch 190 because the direction in the coil is not changed. Switch 190 is linked to differential capacitors, which are used to properly match the different inductances resulting from the change in the direction of current flow. If a relay (e.g., four SPSTs, two SPDTs, or one DPDT) is used in the switch, the relay will typically direct the input to one of the two outputs. If multiple PIN diodes are used in switch 190 (to form a relay function), this provides very high impedance when “off” and low impedance when “on”. Each switch 190 is also linked to one or more capacitors to modify the capacitance, which together with the excitation coil inductors form a resonant circuit. This is necessary because the effective total series inductance of all excitation coils changes when the direction of current flow changes. Inside coil AD, there is also a pair of capacitor assemblies 195 consisting of a center capacitor 197 and metal leads 199 on both sides. In some implementations, the metal leads 199 are attached to a ceramic heat sink to dissipate heat that accumulates during operation.

[0191] During operation, Figure 4A In some implementations, the excitation component is configured to cycle between three configurations, referred to as configuration 1 ( Figure 5 As shown), Configuration 2 ( Figure 6 (as shown) and configuration 3 ( Figure 7 As shown). In configuration 1, as Figure 5 As shown, the current from all four excitation coils is clockwise to simulate the excitation coils that are typically aligned with a plane orthogonal to the Z-axis. In configuration 2, as... Figure 6 As shown, the current from coils A and B is clockwise, while the current from coils C and D is counterclockwise, to simulate the excitation coils that are typically aligned with the Y-axis. In configuration 3, as... Figure 7 As shown, the current from coils A and C is clockwise, while the current from coils B and D is counterclockwise, in order to simulate excitation coils typically aligned with the X-axis. Although this is a preferred embodiment, other combinations of coil polarity and other values ​​of the additional series capacitance may be advantageous for certain label orientations. For example, the current in coil A could be counterclockwise instead of clockwise, and then the other three coils (coils B, C, and D) could have... Figure 5 , Figure 6 or Figure 7 The current flow shown, or the other three coils (coils B, C, and D) will have the following characteristics: Figure 5 , Figure 6 and Figure 7 The opposite current flow is shown. In other embodiments, the current arrangement is as follows: Figure 6As shown, except that the current in coil B is counterclockwise and the current in coil D is clockwise. Every different combination of clockwise and counterclockwise rotation of coil AD is considered (i.e., all sixteen combinations).

[0192] Figure 4A The exemplary excitation assembly 250 is also shown having twelve measurement reference station assemblies 161 (each measurement reference station assembly has a measurement reference coil 160). The twelve measurement reference coils 160 alternate along opposite orientations (along the x-axis and y-axis) to reduce crosstalk. In other embodiments, software may also be used, or alternatively, to reduce crosstalk. In some embodiments, instead of alternating orientations, all measurement reference coils in the measurement reference coils are centered, which increases crosstalk but may have the advantage of offsetting the inflection point in the measurement reference coil signal pickup as the beacon moves across the periphery of the excitation assembly. It is generally preferred that the wires fed into the excitation coils are not adjacent to any of the measurement reference coils in the measurement reference coils to prevent reduced isolation and reduced noise pickup. Figure 4A In this configuration, the wires from the center balun to unbalanced converter circuit to each of the four excitation coils are positioned away from the twelve measuring reference coils 160. Furthermore, as... Figure 4A As shown, the measurement reference coil extends along the left and right sides of the excitation assembly, rather than across the top or bottom of the excitation assembly. Adding a measurement reference station across the top and / or bottom can result in strong crosstalk. Alternatively, if the measurement reference coil is placed in a location that causes crosstalk, a software application can be used to reduce the crosstalk. The measurement reference coil 160 is secured in place by a pair of measurement reference coil supports 165.

[0193] Next to each measurement reference coil 160 is a printed circuit board 170. Each printed circuit board 170 contains a capacitor and a small balun circuit. The capacitor, together with the measurement reference coil, is used to form a resonant circuit. The balun is used to eliminate common-mode effects that would otherwise make the measurement reference coil assembly susceptible to electric field interactions. The balun also functions as an impedance matching element, which matches the actual impedance of the coil / capacitor resonant circuit to the characteristic impedance of the transmission line (typically 50 ohms) by optimally selecting the primary and secondary turns.

[0194] Figure 4AThe excitation assembly 250 is also shown having a pair of self-test transmitters 220. The presence of these self-test transmitters 220 allows a known signal to be applied and the response on all measurement reference coils to be checked. If the measurement reference coils do not show the expected signal, it indicates a system problem, or possibly the presence of interfering magnets or metal pieces that distort the field and reduce overall positioning accuracy. It should be noted that another self-test that can be employed is generating a signal on the excitation coil, which is typically applied to one of the transmitters on an attachment part (e.g., a sheath on a handheld surgical device). By measuring the signal transmitted from the exciter to each measurement reference coil, the level of isolation between them can be confirmed. In yet another self-test, a signal can be applied individually to each measurement reference coil and the remaining measurement reference coils can be used to detect the signal. In other embodiments, field measurement reference coil crosstalk can also be measured in this manner and used for system calibration.

[0195] Figure 4A Various wiring connections between the various components of the excitation assembly are shown. Each measurement reference coil 160 is attached to a coaxial cable, which is connected to the system electronics housing (labeled "controller" 210) via cable bundle 200. The exciter signal enters the center balun circuit 180 from the cable bundle 200. Wires carry the signal from this center balun circuit to the switch 190 and / or capacitor assembly 195. The system electronics housing (controller 210) performs signal processing (e.g., filtering, mixing, amplification, digitization, and demodulation of multi-frequency 'channels') on the measurement reference coil signal. Typically, no A / C mains power supply is applied to the measurement reference coils.

[0196] Regarding the capacitors used in each capacitor assembly 195 and printed circuit board 170, COG / NPO type capacitors with capacitance values ​​that do not change with temperature are typically selected, ensuring that the resonant frequency of the exciter remains constant with temperature. These capacitors also provide a tuning network that can selectively add series capacitance to change the resonant frequency, which helps reduce tolerances during manufacturing and makes it more tolerant of tuning variations due to temperature and other factors. Generally, all materials used should have high dielectric strength and high temperature stability to prevent geometric changes during use of the exciter assembly and with rising temperatures.

[0197] Figure 4B An exemplary measurement reference coil assembly (also known as a measurement reference station assembly) 161 is shown. The measurement reference coil assembly 161 includes two measurement reference coil supports 165 for clamping a measurement reference coil 160 securely against an elastomer 162. Figure 4B and Figure 4CAs shown, the measurement reference coil 160 consists of a metal core (e.g., a ferrite core) 166 and a coil 167 formed of wire. (As exemplary) Figure 4C As shown, the metal core 166 consists of a central region 173 ( Figure 4C The reference coil 160 consists of a conductor-free proximal end 171 and a conductor-free distal end 172. Only the ferrite core (using the conductor-free proximal and distal ends) is held by the bracket 165 and the elastomer 162 (e.g., to provide optimal registration and eliminate the possibility of damaging the coil winding 167 of the measurement reference coil 160). The height of each end of the measurement reference coil 160 can be adjusted up or down by an adjusting screw 163 (present in each measurement reference coil bracket 165), while a restoring force is provided by the elastomer 162. The elastomer thickness and hardness are selected to provide the required restoring force within the desired adjustment range, so that the adjusting screw can be easily adjusted after achieving the optimal position while maintaining the desired setting. Additionally, each of the coil brackets 165 has a “V” or “U” shaped feature that allows them to secure the proximal and distal ends of the metal core 166. This allows, for example, the bracket 165 to be precisely registered in the desired direction to the measurement reference coil core (e.g., the ferrite core), so that it cannot rotate about an axis perpendicular to the plane containing the excitation coil. The measurement reference coil assembly 161 also includes a printed circuit board 170 (with capacitors and balun circuitry) and a Faraday barrier 168. The Faraday barrier may be made of a conductive material such as brass or copper.

[0198] In some implementations, the excitation coil (e.g., as...) Figure 4A The reference coil output (S21) is connected to port 1 of a vector network analyzer or VNA. The measurement reference coil output is typically connected to port 2 of the VNA, and the transmission is measured and displayed (S21). This measurement is a direct measurement of the signal present at port 2, generated by the excitation supplied to port 1, and therefore a direct measurement of isolation. Lower (more negative) S21 is better. A typical isolation value (S21) achieved by a generally preferred embodiment is -70 dB, with an usable range including -50 dB to over -100 dB (e.g., the noise floor of the VNA).

[0199] In general, in order to achieve the best isolation between the excitation coil and the measurement reference coil for optimal accuracy within the maximum navigation volume, it is usually important to position the measurement reference coil orthogonal to (e.g., precisely orthogonal to) the magnetic flux generated by the excitation coil. Figure 4A This orthogonal arrangement of twelve measurement reference coils is shown. Small deviations in height or tilt of the measurement reference coils from this optimal position will typically result in gradually weakening signal coupling from the excitation coil to the measurement reference coils, reducing isolation. Therefore, in some embodiments, fine-tuning is performed using screws (or other connectors) on the measurement reference coil supports.

[0200] Figure 4C An exemplary measuring reference coil 160 is shown, including how coil 167 is formed by winding wire around a metal core in three stages: i) winding direction 1, wherein the wire is wound around the majority of a first half of the metal core; ii) winding direction 2, wherein the wire is wound over the top of the wire wound above the first half and over the majority of a second half of the metal core; and iii) winding direction 3, wherein the wire is wound back over the wire on the second half. In some embodiments, 80-140 windings (e.g., 80...90...112...140) are on each half of the metal core (e.g., a total of 160-280 windings (e.g., 160...200...224...280)). In some embodiments, the wire is 32AWG copper magnetic wire with a single layer of polyester varnish and adhesive coating (e.g., 0.011 inch in diameter), and heat is used during winding to fix the wire joints. In some embodiments, the metal core is... A ferrite core with part number #4077484611 from FAIR-RITE Products. In some embodiments, the metal core (e.g., a ferrite core) has a diameter of about 10mm-15mm (e.g., 10mm…12mm…14mm…15mm) and a length of about 30mm-50mm (e.g., 30mm…35mm…45mm…50mm). In some embodiments, the metal core has a diameter of about 12.7mm and a length of about 41.5mm.

[0201] The wire is also connected (to, for example, in a printed circuit board) to two series capacitors (in a printed circuit board). Figure 4BIn part 170 of the small balun / unbalanced transformer, each series capacitor corresponds to each wire from the coil. Generally, in some embodiments, the total series capacitance is selected to resonate with the inductance of the coil in the label, and the turns ratio of the balun / unbalanced transformer can be selected so that the actual impedance of the resonant coil / capacitor circuit matches the transmission line (e.g., about 50 ohms). In some embodiments, the actual impedance of the resonant coil / capacitor circuit is typically 10 ohms to 25 ohms, but can vary from only a few ohms to greater than 50 ohms, and can be adequately matched by appropriately selecting the primary and secondary turns of the balun / unbalanced transformer. In addition to acting as an impedance transformer, the balun / unbalanced transformer also minimizes any electric field generation / sensitivity from the measuring reference coil assembly; alternatively, it can be considered as eliminating common-mode effects. To further reduce electric field sensitivity, a conductive Faraday barrier 168 is employed on the balun / unbalanced transformer and the capacitor. This Faraday barrier (e.g., a Faraday cage) reduces the observed electric field to components below the barrier. Typically, a Faraday barrier is used to reduce electric field emission from components below the barrier, and in this case, the Faraday barrier also reduces electric field reception.

[0202] Figure 8 The transmitter component 250 with a top cover 230 is shown. The top cover 230 may be made of Kevlar or other suitable tough material. The excitation assembly 250 is shown having a cable bundle 200 guided therein.

[0203] Figure 9 An attachment member 10 is shown, having an angled distal end 300 through which the distal tip 25 of the medical device 20 is inserted. A display member 40 is attached to an attachment member control unit 310 via an attachment member wire 60.

[0204] Figure 10 A shows the distal end 25 of the medical device 20 after initial insertion through the angled distal end 300 of the attachment member 10. This view precedes the insertion of the attachment member wire 60 into the cable management member 315. Figure 10 B shows the attachment component wire 60 before it is attached to the cable management component 315 of the display component housing 330. Figure 10 B also shows a housing tapered connector 340, into which a proximal end tapered connector 350 of the attachment member 10 is inserted. The cable management component 315 has two clamps for aligning both the attachment member conductor 60 and the medical device conductor 50.

[0205] Figure 11An attachment member 10 attached to a display component housing 330 is shown. The attachment member 10 has a pair of positioning transmitters 70 linked to positioning transmitter lead wires 72 located inside a tube 360. The positioning transmitters 70 are powered by the lead wires 72 to generate signals detected by a measurement reference coil. The attachment member also has an angled distal end 300 with a distal end opening 305, which allows the tip of a medical or other device to be inserted through it. The display component housing 330 has a cable management member 315 consisting of a pair of clamps for holding the attachment member leads and the medical device leads.

[0206] Figure 12 An exemplary attachment member 10 is shown attached to a display component housing 330 in which the display component 40 is located. A display cover 370 is shown for securing the display component 40 inside the display component housing 330. An adhesive strip 380 (e.g., a double-sided strip with strong adhesive on both sides) is also shown, the shape and size of which are configured to fit inside the attachment member and facilitate securing a medical device to the attachment member.

[0207] Figure 13 A shows a proximal end tapered connector 350 of the attachment member 10, which is configured to be pushed into a housing tapered connector 340 of the display member housing 330. Figure 13 B shows Figure 13 A close-up of section A, which includes a cable management tapered connector 317, part of the cable management component 315 and designed to insert into a tapered connection hole 319 in the display component housing 330. The cable management tapered connector 317 includes a flat portion 318 for locking angular position.

[0208] Figure 14 An exemplary system for locating a tag implanted in a patient is shown. The system comprises an excitation assembly that emits a signal to activate the tag within the patient's body. The system's electronic housing is shown as a mobile trolley that delivers signals to the excitation assembly and receives and processes signals from the tag within the patient's body and from a positioning transmitter in an attachment component. Surgical guidance is displayed on a screen on a display component and the system's electronic housing.

Claims

1. A system comprising a linking locator, comprising: a) At least two tags, b) A linker attached to the at least two tags; c) A remote activation device that generates a magnetic field within the area of ​​each label; as well as d) A plurality of sensors configured to detect signals from each tag when each tag is exposed to the magnetic field; Specifically, when the label is present in the insertion device, the connector holds the at least two labels in a first position, and when the connector is present in the tissue, the connector holds the at least two labels in a second position.

2. The system according to claim 1, further comprising: A wire or line, wherein the wire or line is attached to and / or passes through the connector at two or more points on the connector.

3. The system of claim 2, wherein the wire or line is attached to and / or passes through the connector such that the two or more tags are held in a first position relative to each other, and wherein the connector is configured to hold the two or more tags in a second position when the wire or line is not attached to and / or does not pass through the connector, wherein the second position is different from the first position.

4. The system of claim 1, wherein the connector comprises a torsion spring.

5. The system of claim 1, wherein each of the tags is attached to the connector via heat shrink tubing.

6. The system of claim 1, wherein at least one of the tags in the second position points generally along the X dimension, and at least one of the tags points generally along the Y dimension.

7. The system of claim 1, wherein the at least two labels include a first label, a second label and a third label, and wherein when in the second position: i) the first label points approximately along the X dimension, ii) the second label points approximately along the Y dimension, and iii) the third label points approximately along the Z dimension.

8. The system of claim 1, wherein the connector is a flexible connector.

9. The system of claim 1, wherein the connector comprises plastic.

10. The system of claim 1, wherein the connector comprises a shape memory alloy.

11. The system of claim 10, wherein the shape memory alloy comprises a nickel-titanium alloy.

12. The system of claim 11, wherein the nickel-titanium alloy is Nitinol 55 or Nitinol 60.

13. The system of claim 1, wherein the at least two tags are positioned at an angle ranging from 15 to 40 degrees.

14. The system of claim 13, wherein the angle is 25 degrees.

15. The system of claim 1, wherein the connector includes a gripper capable of being held by a surgical instrument.

16. The system of claim 15, wherein the gripping part is a sphere.

17. The system of claim 15, wherein the connector is positioned within an encapsulation having a slot exposing the gripper.

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