WO2025072006A1 - Procédés de localisation d'étiquettes de transpondeurs intégrés passifs, et dispositifs et systèmes les incorporant - Google Patents

Procédés de localisation d'étiquettes de transpondeurs intégrés passifs, et dispositifs et systèmes les incorporant Download PDF

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Publication number
WO2025072006A1
WO2025072006A1 PCT/US2024/047247 US2024047247W WO2025072006A1 WO 2025072006 A1 WO2025072006 A1 WO 2025072006A1 US 2024047247 W US2024047247 W US 2024047247W WO 2025072006 A1 WO2025072006 A1 WO 2025072006A1
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WIPO (PCT)
Prior art keywords
tissue
pit
reading device
probe
pit tag
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PCT/US2024/047247
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English (en)
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Ciaran Purdy
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Hologic Inc
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Hologic Inc
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3908—Soft tissue, e.g. breast tissue

Definitions

  • the present disclosure generally relates to the field of location devices. More specifically, the disclosure relates to the field of localization devices and methods associated with locating passive integrated transponder tags (hereinafter "PIT tags”), and devices and systems incorporating same.
  • PIT tags passive integrated transponder tags
  • PIT tags have been used for many years to identify specimens, including livestock, domestic pets, birds, fish, and other marine animals for various management and/or research purposes. PIT tags have also been used for clinical purposes, such as, for example, to identify areas of interest within a patient’s body and, for example, assist a surgeon in locating the area during a surgical procedure. In the field of women’s health, for example, PIT tags have been used as localization devices to mark breast lesions for later investigation and/or surgical removal of the lesions. Each PIT tag generally includes a small ferrite-cored coil attached to a microchip.
  • the microchip has a capacitor that causes the coil to resonate at a predetermined frequency when energized and circuitry to generate and transmit a coded identification number or message in response to a received interrogation signal which energizes the coil.
  • PIT tags do not contain an internal energy source. Instead, energy needed to transmit the coded identification number is obtained through an electromagnetic coupling, which causes a transfer of energy from a powered device to the PIT tag.
  • PIT tags for example, are generally configured to respond to a signal emitted from a scanner. These scanners, also known as “readers,” send out an electromagnetic charge, and when a PIT tag is within range, the transponder it contains reacts to this charge and transmits the tag’s unique identification code via a radio frequency (RF) signal.
  • RF radio frequency
  • a “PIT tag reader,” “reading device,” or just “reader” is, therefore, a device that is capable of receiving a coded identification number transmitted by a PIT tag and displaying the number.
  • a “PIT tag reading device” is a radio frequency identification (RFID) reader that uses electromagnetic fields (RF signals) to automatically identify a unique identification number associated with a respective PIT tag.
  • RFID radio frequency identification
  • a PIT tag is a small, pill-shaped cylinder of glass that houses a radio transponder containing the PIT tag’s unique code.
  • the glass covering, or envelope of a PIT tag is about 2 mm in diameter and about 1 1 mm in length, although other packaging is possible as would be understood by those of ordinary skill in the art.
  • PIT tags are usually injected up to a few centimeters below the outer surface of an object or the specimen's skin using a hypodermic syringe and are typically read by a PIT tag reading device that is brought within close range of the PIT tag.
  • PIT tag readers generally do not have the capability to distinguish between various incoming RF signals, they often experience large amounts of interference while attempting to read an individual PIT tag. For example, as a PIT tag reading device is brought within range of a given PIT tag, the reader can pick up the RF signals from other RF devices within its range, including, but not limited to other medical devices (which emit RF signals) within the vicinity of the PIT tag, and/or pick up friction interference from itself (e.g., from movement at its wire connections). This interference can make it difficult to discern the specific RF signal from the PIT tag, which the reader is looking for to identify the location of the PIT tag, from the other RF signals and noise.
  • PIT tag reading devices can also be configured to provide an audible indication when a signal is detected, such false detections can be annoying to a person using the reader to locate a PIT tag and to others nearby. These issues can be particularly problematic within an operating room suite in which the PIT tag reading device is being employed during a surgical procedure.
  • a method for locating a passive integrated transponder (PIT) tag embedded in tissue includes moving a reading device relative to an area of interest in the tissue.
  • the reading device includes a probe having a coil at a distal end thereof. The coil is configured to transmit a signal resonating at a frequency of the PIT tag embedded within the tissue.
  • the method also includes receiving one or more radio frequency (RF) signals with the reading device and determining whether at least one of the one or more RF signals is a radio frequency identification (RFID) signal transmitted by the PIT tag embedded within the tissue.
  • the method further includes generating an indication of a presence and/or location of the PIT tag only when a RFID signal transmitted by the PIT tag embedded within the tissue is detected.
  • RF radio frequency
  • a method for locating a PIT tag embedded in tissue includes moving a reading device over an area of interest in the tissue to identify an approximate location of the PIT tag embedded within the tissue.
  • the reading device includes a probe having a coil at a distal end thereof. The coil is configured to transmit a signal resonating at a frequency of the PIT tag embedded within the tissue.
  • the method also includes forming an incision in the tissue adjacent to the location of the PIT tag and inserting the probe into the incision.
  • the method additionally includes receiving electromagnetic signals and determining whether each of the received electromagnetic signals includes a unique identifier.
  • the method further includes generating an output for each of the received electromagnetic signals that includes a unique identifier.
  • a system for locating one or more PIT tags in a body includes one or more PIT tags configured for implantation within a body. Each of the one or more PIT tags is configured to transmit an electromagnetic signal including a unique identifier of the respective PIT tag.
  • the system also includes a handheld device including a probe having a coil at a distal end thereof. The coil is configured to transmit a signal resonating at a designated operating frequency of the one or more PIT tags. The probe is configured for insertion into an incision in the body in order to advance the coil towards the one or more PIT tags located within the body.
  • the handheld device is configured to receive electromagnetic signals and determine whether each of the received electromagnetic signals includes a unique identifier. The handheld device is also configured to generate an output only when one of the received electromagnetic signals includes a unique identifier.
  • a method for locating a localization device embedded in breast tissue includes moving a reading device relative to an area of interest in the breast tissue.
  • the reading device includes a probe having a coil at a distal end thereof. The coil is configured to transmit a signal resonating at a frequency of the localization device embedded within the tissue.
  • the method also includes receiving one or more radio frequency (RF) signals with the reading device and determining whether at least one of the one or more RF signals is a radio frequency identification (RFID) signal transmitted by the localization device embedded within the breast tissue.
  • the method further includes generating an indication of a presence and/or location of the localization device only when a RFID signal transmitted by the localization device embedded within the breast tissue is detected.
  • RF radio frequency
  • a method for locating a localization device embedded in breast tissue includes moving a reading device over an area of interest in the breast tissue to identify an approximate location of the localization device embedded within the breast tissue.
  • the reading device includes a probe having a coil at a distal end thereof. The coil is configured to transmit a signal resonating at a frequency of the localization device embedded within the breast tissue.
  • the method also includes forming an incision in the breast tissue adjacent to the location of the localization device and inserting the probe into the incision.
  • the method additionally includes receiving electromagnetic signals and determining whether each of the received electromagnetic signals includes a unique identifier.
  • the method further includes generating an output for each of the received electromagnetic signals that includes a unique identifier.
  • FIG. 1 is a side view of an exemplary locating system in accordance with the present disclosure
  • FIG. 2 is an overhead plan view of an exemplary PIT tag reading device of the locating system of FIG. 1;
  • FIG. 3 is a cross-sectional view of an exemplary pencil probe for use with the PIT tag reading device of FIG. 2;
  • FIG. 4 is a block diagram of an exemplary apparatus capable of locating a PIT tag and reading an associated tag identification number
  • FIG. 5 is a flowchart illustrating an exemplary method of using the PIT tag reading device of FIG. 2.
  • Passive integrated transponder (PIT) tags are useful for providing identification (ID) information about a particular PIT tag that is embedded in a body or specimen.
  • PIT tags are used as localization devices to mark breast lesions for later investigation and/or surgical removal of the lesions.
  • an actual physical location of a specific PIT tag within the object or specimen e.g., embedded within the breast of a patient at the location of a lesion
  • Contemplated readers can, for example, use electromagnetic couplings to change load conductance on an oscillator, which is measured and output to an accessory to provide an audio and/or visual indication to a user, thereby allowing the user to determine the position of the PIT tag embedded within the object or specimen, including the depth of the PIT tag relative to a coil of the reading device (e.g., relative the outer surface of the breast).
  • Such improved reading devices can, for example, reduce the need for exploratory surgery or other locating methods to determine the location of the PIT tag within the object or embedded within the tissue of the specimen (e.g., within the breast of a patient).
  • the reader can be susceptible to interference from other sources.
  • the reader can pick up radio frequency (RF) signals from other devices within its range, including other mobile communication and/or medical devices within the vicinity of the PIT tag (e.g., iPhone, watch, cautery device, etc.), and/or pick up friction interference from its own components (e.g., from movement at its wire connections as the reader is advanced within an incision in the tissue).
  • RF radio frequency
  • This interference, or noise can make it difficult for the reader to discern the specific RF signal from the PIT tag, thereby resulting in the reader providing false audio and/or visual feedback (i.e., indications) to the user (e.g., surgeon).
  • PIT tag reading devices can employ improved methods for locating PIT tags that function to isolate and act on signals that have identification numbers associated with them, while ignoring all other signals.
  • a method for locating a PIT tag embedded in tissue includes moving a reading device relative to an area of interest in the tissue (e.g., breast) to receive one or more radio frequency (RF) signals with the reading device.
  • the reading device can, for example, include a probe having a coil at a distal end, wherein the coil is configured to transmit a signal resonating at a frequency of the PIT tag, as will be described further below.
  • the method also contemplates isolating a radio frequency identification (RFID) signal associated with the PIT tag from other RF signals based on the identification number contained within the RFID signal and providing feedback (e.g., an audible or visual indication) only for the isolated RFID signal.
  • RFID radio frequency identification
  • the reader will therefore only provide feedback for an electromagnetic signal, audible or otherwise, when there is a number associated with the signal.
  • exemplary methods of the present disclosure contemplate performing the steps of 1) determining whether at least one of the one or more RF signals is an RFID signal transmitted by the PIT tag embedded within the tissue; and 2) generating an indication of the presence and/or location of the PIT tag only when a RFID signal transmitted by the PIT tag embedded within the tissue is detected.
  • systems for locating PIT tags in accordance with the present disclosure which include PIT tag reading devices, are configured to employ such methods to receive electromagnetic signals, determine whether each of the received electromagnetic signals includes a unique identifier, and generate an output only when a received electromagnetic signal includes a unique identifier.
  • the locating system 10 includes a transponder, such as a PIT tag 12, and a transceiver, such as a PIT tag reading device 14.
  • the PIT tag 12 is configured to be implanted within tissue, such as, for example, under the skin of a specimen 16 (e g., within a breast 16 of a patient).
  • the PIT tag 12 is further capable of transmitting a response signal when energized by an interrogating signal or electromagnetically coupled to a driven coil such as a coil in the reading device 14.
  • the PIT tag reading device 14 includes a processing and display unit 18 for analyzing data such as a load conductance, strength of a signal emitted by the transponder, and, optionally, encoded content of a message incorporated in this signal, such as, for example information relating to an identification number of the PIT tag 12.
  • the reading device 14 also includes a search coil 20, which in some embodiments is annular or cylindrical in shape, attached to the processing and display unit 18.
  • the search coil 20 can be driven at a pre-selected frequency substantially equal to the natural resonant frequency of the PIT tag 12.
  • the processing and display unit 18 can be housed in a hand-held case 22 that includes a display window 24.
  • the display window 24 can be used to provide visual indications to a user regarding a located PIT tag, such as, for example, distance and/or PIT tag identification number information.
  • a located PIT tag such as, for example, distance and/or PIT tag identification number information.
  • the PIT tag reading device 14 can measure a distance D between the search coil 20 and the PIT tag 12 when the search coil 20 is energized due to electromagnetic coupling to the PIT tag 12.
  • the search coil 20 may be moved laterally (i.e., in any of the directions indicated by the arrows L) over the skin of the specimen 16 (i.e., within an area of interest of the specimen) at a small distance above the skin or at the surface thereof to determine an approximate lateral position of a PIT tag 12 implanted within the tissue of the specimen 16.
  • the search coil 20 can be lowered to contact the skin of the specimen 16 to determine the depth at which the PIT tag 12 was implanted, which can be calculated by the processing and display unit 18 based upon (i) a change in load conductance when there is electromagnetic coupling between the reading device 14 and the PIT tag 12, or (ii) a strength of the transponder signal received from the PIT tag 12, and the depth can be viewed via the display window 24.
  • the display window can also show information corresponding to a strength of the signal in graphical form (e.g., via a bar graph), information relating to an orientation of the tag relative to the search coil 20 in graphical or textual form, an icon that is illustrative of the current mode of the device (e.g., loop mode vs. probe mode), an identification number of the PIT tag 12, and/or the battery life of the reading device 14.
  • the measured data displayed by the PIT tag reading device 14 will depend upon the size, shape, and orientation of the search coil 20 in relation to the PIT tag 12, as well as the distance D between the PIT tag and the search coil 20.
  • the maximum generated response for a PIT tag 12 that is oriented parallel to a center axis Z of the search coil 20 will occur when the center of the search coil is directly over the center of the PIT tag.
  • a PIT tag 12 that is oriented obliquely relative to the center axis Z of the search coil 20 will generate a maximum response when the PIT tag is slightly off-center relative to the center axis Z of the search coil, and a horizontal PIT tag (i.e., a PIT tag oriented perpendicular to the center axis of the search coil) will generate two maxima of positions a little to either side of center of the PIT tag, with lower values in between the two maxima.
  • a horizontal PIT tag i.e., a PIT tag oriented perpendicular to the center axis of the search coil
  • the reading device 14 may include a pencil-shaped probe 130, having a coil 144 at a distal end thereof, to locate a PIT tag 12.
  • the probe 130 for example, is configured for insertion into an incision in the tissue of the specimen (e.g., specimen 16) and is therefore generally formed from a relatively long and thin cylindrical tube 132 having a first, proximal end 134 and a second, distal end 136.
  • the tube 132 may be made of any durable material that will not adversely react with the specimen, including, but not limited to, plastic and/or stainless steel, and preferably has an outer diameter of about 4 mm to about 8 mm and a length of about 150-200 mm. In some embodiments, as shown in FIG.
  • the first end 134 of the tube 132 is capped by a plastic cap 138, and the second end 136 of the tube 132 is fitted with a cable or connector 140 so that the probe 130 can be connected to the processing and display unit 18.
  • a coil 144 is positioned within the second, distal end 136 of the of the tube 132.
  • the coil 144 is ferrite-cored and is disposed within the plastic cap 138.
  • the coil 144 functions as a search coil similar to the search coil 20 of FIG. 1, and is configured to output a signal to the processing and display unit 18 via lead wires 142 and the connector 140 located at the proximal end 134 of the tube 132.
  • an approximate lateral location of the PIT tag 12 can first be determined using the search coil 20, as discussed above.
  • the reading device is in a “loop mode” or “search mode,” in which the search coil 20 scans laterally across a surface of the skin (e.g., a surface of the breast) until it detects a strong RF signal.
  • search coil 20 is moved perpendicularly into contact with the breast, and if necessary to isolate the signal, compress the soft tissue of the breast. The surgeon can then mark this location as a reference point, for example, with a marker or felt tip pen on the surface of the skin.
  • the reading device 14 can then be switched into a “pencil mode” or “probe mode,” in which the reading device will now use the probe 130 to further locate the PIT tag 12. For example, an incision can then be made in an area that will reduce visible scarring for the patient (e.g., around the areola or on a fold under the breast during a breast surgery), and the probe 130 can be used to locate the PIT tag 12 while referencing the visible mark on the surface of the skin.
  • the reading device 14 can be configured to switch from an initial, search or “loop mode” in which it utilizes the search coil 20 to determine an approximate lateral location of the PIT tag 12 into a secondary, probe or “pencil mode” in which the reading device 14 utilizes the probe 130 to determine a more precise location of the PIT tag 12.
  • the processing and display unit 18 can be configured, for example, to switch the reading device 14 between the modes (i.e., activate the pencil mode) when the probe 130 is connected to the reading device 14 via the connector 140 (e.g., when the processing and display unit 18 receives a signal from the lead wires 142 of the probe).
  • the probe 130 can also be used to determine the approximate lateral location of the PIT tag 12 (i.e., such that the search coil 20 is not used), although the probe 130 may be less accurate than the search coil 20 due to its reduced size.
  • a small incision can then be made in the specimen 16 at either the determined lateral location or at another approximate location that will reduce visible scarring for the patient, and the probe 130 can be inserted in the incision.
  • the probe 130 may then be manipulated within the incision to determine the shortest distance between the PIT tag 12 and the coil 144.
  • the range of the probe 130 is generally less than that of the search coil 20.
  • Contemplated search coils 20 can, for example, have a range of about 6 cm. Exemplary embodiments of the present disclosure, however, contemplate probes 130 with extended ranges compared to previously available probes.
  • probes can generally start to pick up RF signals at about 6 cm, but are not able to determine (i.e., read) an identification number within an RFID signal until the probe is within about 1-2 cm of the PIT tag.
  • Contemplated probes 130 can have an increased range such that when using the probe 130 (i.e., when the reading device 14 is in pencil mode) the reading device 14 is able to read an identification number of the PIT tag 12 at an increased distance of about 3 cm from the PIT tag 12.
  • the probe 130 has an increased sensitivity such that it can identify an RFID signal (i.e., read an identification number) earlier than was previously possible, thereby also helping to prevent unwanted feedback as the probe 130 is continuously moved toward the PIT tag 12.
  • the reading device 14 is therefore configured to not only locate an implanted PIT tag 12, but also read a tag identification number associated with the PIT tag 12.
  • the signal e.g., radio frequency identification (RFID) signal
  • RFID radio frequency identification
  • the signal and message can be decoded using known techniques, as would be understood by those of ordinary skill in the art and are therefore not discussed in detail herein.
  • FIG. 4 an exemplary circuit 160 that may be used with the reading device 14 is illustrated.
  • the reading device 14 is capable of PIT tag location, reading a decoded tag identification number, and automatic detection of a probe (i.e., to switch the reading device 14 into pencil mode from loop mode).
  • a microcontroller 72 can use a crystal 74 to control a drive frequency that is selected to match a resonance frequency of a selected PIT tag 12.
  • the drive frequency can be derived from a timer output of the microcontroller 72.
  • other methods of obtaining the drive frequency are contemplated, such as by using a frequency synthesizer.
  • An output of the microcontroller 72 is then input into a drive circuit 76 that drives a resonator 162 (shown in dashed lines) that is formed from a capacitor C and a plug-in coil or probe 164 (e g., either search coil 20 or probe 130) connected to the circuit 160 via a socket 166.
  • the output of the drive circuit 76 is connected to one end of the capacitor C.
  • the other end of the capacitor C is connected to the socket 166 and a demodulator 86.
  • the socket 166 for example, can provide a tight connection between the circuit and the search coil 20 or probe 130, thereby also helping to prevent friction interference from the reading device 14 itself.
  • the resonator 162 is driven at a particular frequency and with enough power to generate an interrogation signal that excites a response from the PIT tag 12 when electromagnetic coupling between the resonator 162 and the PIT tag 12 occurs.
  • the response signal generated by the PIT tag 12 is superimposed onto the interrogating signal across the resonator 162 and is demodulated by the demodulator 86.
  • a bandpass amplifier 90 receives the output of the demodulator 86 which includes the interrogating signal as an input, and separates the interrogating signal from the response signal.
  • the response signal is provided as the output of the bandpass amplifier 90 and is input into both a comparator 168 that converts the response signal to logic levels suitable for the microcontroller interface and a peak detector 92.
  • the output of the comparator 168 includes the tag identification number transmitted by the PIT tag 12 in its response signal.
  • the output of the peak detector 92 is a voltage that is related to the distance D between the PIT tag 12 and the coil or probe 164.
  • a probe detector 170 detects whether the search coil 20 or the probe 130 is connected to the circuit 160 via the socket 166.
  • the search coil 20 may be fixed (i.e., constantly connected to circuit 160), as in FIGS. 1 and 2, such that it is only the probe 130 that is attached using a plug and socket.
  • the output of the probe detector 170 is provided to the microcontroller 72 so that the microcontroller can switch the reading device 14 between modes (e.g., between the loop mode and the pencil mode) to properly interpret the received data.
  • the microcontroller 72 is configured to switch the reading device 14 into the pencil mode.
  • the microcontroller 72 is also connected to one or more switches (two switches SI, S2 being shown in the embodiment of FIG. 4).
  • the switches SI, S2 for example, allow a user to adjust the settings of the reading device 14, such as audio tone amplitude and display backlight level.
  • the switches SI, S2 are also configured to allow the reading device 14 to read, store, and display the information relating to an identification number of a detected PIT tag that is within range of the reading device 14. If no PIT tag 12 is within an operating range (i.e., capable of electromagnetically coupling with the search coil 20 or probe 130), the switches SI, S2 may have an alphanumeric display 126 show previously-stored tag identification numbers.
  • Microcontroller flash memory or an external EEPROM for example, may be used to store tag identification numbers and selected audio and/or backlight levels.
  • the microcontroller 72 also provides an output to a frequency synthesizer 118 to generate a tone that is related to the distance D between the PIT tag 12 and the search coil 20 or probe 130.
  • the output of the frequency synthesizer 118 is input into an amplifier 120.
  • Another output of the microcontroller 72 is fed into a digital -to-analog converter 172.
  • the digital -to- analog converter 172 connects to the amplifier 120, and sets the gain of the amplifier.
  • the output of the amplifier 120 is provided to a loudspeaker 106, which creates an audible tone as an indication of the distance D between the PIT tag 12 and the search coil 20 or probe 130 to a user.
  • the microcontroller 72 also outputs another signal to the alphanumeric display 126 which can display a visual indication of the distance D, such as, for example, as a bar graph and scale.
  • the microcontroller 72 is further configured to ignore all signals that do not contain information relating to an identification number (e.g., ignore any signals that are not an RFID signal). In some embodiments, the microcontroller 72 is therefore configured to receive electromagnetic signals, determine whether each of the received electromagnetic signals includes a unique identifier for a PIT tag (e.g., PIT tag 12), and generate an output only when one of the received electromagnetic signals includes a unique identifier.
  • RF radio frequency
  • the microcontroller 72 is configured to provide an output to the frequency synthesizer 118 (i.e., to generate an audible tone) and/or an output to the alphanumeric display 126 (i.e., to display a visual indication) only when there is a unique identifier associated with the received electromagnetic signal.
  • the microcontroller 72 is therefore able to ignore unwanted signal noise and prevent outputs that can lead to false indications.
  • the microcontroller 72 may be configured to start monitoring the received signals to identify the signals with associated identification codes (e.g., determine which signals are RFID signals, while ignoring the other RF signals) upon entry into probe/pencil mode.
  • the microcontroller 72 may begin to isolate RFID signals from the other RF signals based on the information relating to the identification number embedded in the RFID signals, and then provide an output to the frequency synthesizer 118 and/or an output to the alphanumeric display 126 only for the isolated RFID signals (i.e., to provide an indication of only the isolated RFID signals). It will be understood, however, that microcontroller 72 can employ the disclosed signal noise reduction methods while in any mode of operation.
  • reading device 14 described above with reference to FIGS. 1-4 is exemplary only and that various types and configurations of locating apparatuses may be used in accordance with the disclosed methods and systems to locate one or more PIT tags that are implanted within a specimen (e.g., embedded in tissue).
  • a specimen e.g., embedded in tissue
  • contemplated reading devices may include only one type of probe (search coil 20 or pencil probe 13) or have additional types and configurations of probes having coils that are configured to transmit a signal that resonates at a frequency of the one or more PIT tags.
  • location circuit 160 described above with reference to FIG. 4 is exemplary only and that various configurations of circuits, utilizing various components including various microcontrollers 72, may be used in the contemplated reading devices to execute the contemplated methods.
  • location circuits may be utilized that include one or more relays, such that the location circuit can change its resonant frequency of oscillation to match a resonant frequency of a PIT tag, as disclosed in U.S. Patent Nos. 8,973,584, 9,867,550, and 10,849,529, the entire content of each which is incorporated by reference herein.
  • the method 200 includes a step 210 of providing a search mechanism, such as, for example, the reading device 14 adjacent to an object surface.
  • a search mechanism such as, for example, the reading device 14 adjacent to an object surface.
  • the PIT tag 12 is discussed as being embedded in tissue, such as, for example, under the skin of a specimen 16 as discussed above, it would be understood that the PIT tag 12 could be implanted in any object and is not in any manner limited to being embedded within tissue or under skin.
  • step 210 can include moving the reading device 14 relative to the tissue, for example, in an area of interest (e.g., in an area in which the PIT tag is known to have been implanted).
  • the reading device 14 can include a handheld device that includes a probe having a coil at a distal end thereof. As discussed above, in some embodiments, the reading device 14 can be used in two different modes: 1) a first “loop” mode, in which a first probe, coil 20, of the reading device 14 is used to determine an approximate lateral location of a PIT tag 12, and 2) a second “pencil” mode in which a second probe, pencil probe 130 with a coil 144, is used to determine a more precise location of the PIT tag 12. In this manner, step 210 can include one or both of moving the coil 20 over the tissue, in an area of interest, to identify an approximate location of the PIT tag 12 embedded within the tissue and then inserting the probe 130 into an incision in the tissue.
  • the contemplated methods may further include a step of forming an incision in the tissue, for example, adjacent to the approximate location of the PIT tag that is first located by the coil 20, and then inserting the probe 130 into the incision.
  • the reading device 14 is in the second, pencil mode in which the probe 130 is inserted into and advanced within an incision.
  • the search mechanism receives one or more radio frequency (RF) signals.
  • the microcontroller 72 can receive RF signals that are within a range of the probe 130 (i.e., that are capable of electromagnetically coupling with the probe 130), with one of the received RF signals being a radio frequency identification (RFID) signal from the PIT tag 12.
  • RFID radio frequency identification
  • the RFID signal can contain information relating to an identification number of the PIT tag 12 and information relating to a depth D of the PIT tag 12.
  • the microcontroller 72 can begin to identify an identification number in an RFID signal within a range of about 3 mm from the PIT tag 12.
  • step 214 it is determined whether at least one of the one or more RF signals is a RFID signal transmitted by the PIT tag 12 (i.e., includes information relating to an identification number associated with the PIT tag 12).
  • the microcontroller 72 isolates the RFID signal from other RF signals based on the identification number included in the signal. If the signal includes an identification number (i.e., if the signal is a RFID signal with a unique identifier associated with the signal), it is determined that a PIT tag has been located, and the process proceeds to step 216, otherwise the signal is ignored at step 218.
  • an indication of the presence and/or location of the PIT tag is generated for the isolated RFID signal (i.e., for the located PIT tag 12).
  • an audible and/or visual indication of a depth D of the PIT tag 12 is generated and, in other embodiments, a visual indication of the identification number of the PIT tag 12 is generated.
  • An audible indication can include, for example, a beeping noise that can change in tone, pattern, and/or volume as the probe 130 gets closer to the PIT tag, while a visual indication can include display a graphical representation of the depth D, distance, and/or orientation between the probe 130 and the PIT tag 12.
  • the microcontroller 72 provides an output to the frequency synthesizer 118 (i.e., to generate an audible tone) and/or an output to the alphanumeric display 126 (i.e., to display a visual indication).
  • the microcontroller 72 ignores the signal and does not generate an audible and/or visual indication on the reader.
  • PIT tag locating apparatuses such as, for example, the reading device 14 may utilize method 200 to sift through the signal noise that is often encountered during a PIT tag locating procedure, allowing the reading device to ignore unwanted signals that can lead to false indications.
  • more than one PIT tag can also be detected via the identification numbers associated with the tags, such that each PIT tag generates an audible signal and a physician (e.g., surgeon) would be able to determine a specific tag based on the unique identification number that is displayed on the display window.
  • a method for locating a passive integrated transponder (PIT) tag embedded in tissue comprising: moving a reading device relative to an area of interest in the tissue, the reading device including a probe having a coil at a distal end thereof, the coil being configured to transmit a signal resonating at a frequency of the PIT tag embedded within the tissue; receiving one or more radio frequency (RF) signals with the reading device; determining whether at least one of the one or more RF signals is a radio frequency identification (RFID) signal transmitted by the PIT tag embedded within the tissue; and generating an indication of a presence and/or location of the PIT tag only when a RFID signal transmitted by the PIT tag embedded within the tissue is detected.
  • RF radio frequency
  • Clause 2 The method of clause 1 , wherein determining whether at least one of the one or more RF signals is a radio frequency identification (RFID) signal transmitted by the PIT tag embedded within the tissue includes determining whether an identification number is associated with the RF signal.
  • RFID radio frequency identification
  • Clause 3 The method of clause 1 or clause 2, wherein generating an indication of the presence and/or location of the PIT tag only when a RFID signal transmitted by the PIT tag embedded within the tissue is detected includes isolating the RFID signal from any other RF signals received by the reading device based on the presence of the identification number associated with the RFID signal.
  • Clause 4 The method of any of clauses 1-3, wherein moving the reading device relative to an area of interest in the tissue comprises moving the reading device relative to an area of interest in a breast of a patient.
  • Clause 7. The method of any one of clauses 1-6, wherein moving the reading device relative to the area of interest in the tissue comprises inserting the probe into an incision in the tissue.
  • Clause 8. The method of any one of clauses 1-7, wherein the at least one RFID signal includes information relating to a depth of the PIT tag relative to the coil.
  • Clause 9 The method of any one of clauses 1-8, wherein generating an indication of the presence and/or location of the PIT tag only when a RFID signal transmitted by the PIT tag embedded within the tissue is detected comprises providing an audible indication of a depth of the PIT tag as the probe is advanced within the incision.
  • Clause 10 The method of any one of clauses 3-9, wherein isolating the RFID signal comprises ignoring any RF signal that does not have information relating to an identification number.
  • Clause 12 The method of any one of clauses 1-11, wherein generating an indication of the presence and/or location of the PIT tag only when a RFID signal transmitted by the PIT tag embedded within the tissue is detected comprises generating an audible indication.
  • Clause 13 The method of any one of clauses 1-12, wherein generating an indication of the presence and/or location of the PIT tag only when a RFID signal transmitted by the PIT tag embedded within the tissue is detected comprises generating a visual indication of the identification number of the PIT tag.
  • Clause 14 The method of clause 13, wherein generating the visual indication of the identification number comprises displaying the identification number of the PIT tag on a display device.
  • a method for locating an integrated transponder (PIT) tag embedded in tissue comprising: moving a reading device over an area of interest in the tissue to identify an approximate location of the PIT tag embedded within the tissue, the reading device including a probe having a coil at a distal end thereof, the coil being configured to transmit a signal resonating at a frequency of the PIT tag embedded within the tissue; forming an incision in the tissue adjacent to the location of the PIT tag; inserting the probe into the incision; receiving electromagnetic signals; determining whether each of the received electromagnetic signals includes a unique identifier; and generating an output for each of the received electromagnetic signals that includes a unique identifier.
  • PIT integrated transponder
  • Clause 17 The method of clause 15, wherein generating the output comprises providing an audible indication of a depth of the PIT tag relative to the coil as the probe is advanced within the incision.
  • Clause 18 The method of clause 15, wherein generating the output comprises providing a visual indication of the unique identifier.
  • Clause 19 The method of clause 18, wherein providing the visual indication of the unique identifier comprises displaying an identification number of the PIT tag on a display device.
  • a system for locating one or more passive integrated transponder (PIT) tags in a body comprising: one or more PIT tags configured for implantation within a body, each of the one or more PIT tags being configured to transmit an electromagnetic signal including a unique identifier of the respective PIT tag; and a handheld device including a probe having a coil at a distal end thereof, the coil being configured to transmit a signal resonating at a designated operating frequency of the one or more PIT tags, the probe being configured for insertion into an incision in the body in order to advance the coil towards the one or more PIT tags located within the body, the handheld device being configured to: receive electromagnetic signals; determine whether each of the received electromagnetic signals includes a unique identifier; and generate an output only when one of the received electromagnetic signals includes a unique identifier.
  • Clause 21 The system of clause 20, wherein the handheld device is configured to generate an audible indication when one of the received electromagnetic signals includes a unique identifier.
  • Clause 22 The system of clause 21, wherein the audible indication comprises an audible beeping and/or speaking.
  • Clause 23 The system of any one of clauses 20-22, wherein the handheld device is configured to generate a visual indication when one of the received electromagnetic signals includes a unique identifier.
  • Clause 24 The system of clause 23, further comprising a display device configured to show the visual indication of the unique identifier.
  • Clause 25 The system of clause 23, wherein the visual indication comprises a string of numbers and/or a graphic image.
  • Clause 26 The system of clause 20, wherein the one or more PIT tags are configured for implantation within a breast of a patient.
  • a method for locating a localization device embedded in breast tissue comprising: moving a reading device relative to an area of interest in the breast tissue, the reading device including a probe having a coil at a distal end thereof, the coil being configured to transmit a signal resonating at a frequency of the localization device embedded within the tissue; receiving one or more radio frequency (RF) signals with the reading device; determining whether at least one of the one or more RF signals is a radio frequency identification (RFID) signal transmitted by the localization device embedded within the breast tissue; and generating an indication of a presence and/or location of the localization device only when a RFID signal transmitted by the localization device embedded within the breast tissue is detected.
  • determining whether at least one of the one or more RF signals is a radio frequency identification (RFID) signal transmitted by the localization device embedded within the breast tissue includes determining whether an identification number is associated with the RF signal.
  • Clause 29 The method of clause 27 or claim 28, wherein generating an indication of the presence and/or location of the localization device only when a RFID signal transmitted by the localization device embedded within the breast tissue is detected includes isolating the RFID signal from any other RF signals received by the reading device based on the presence of the identification number associated with the RFID signal.
  • Clause 30 The method of any one of clauses 27-29, wherein moving the reading device relative to the area of interest in the breast tissue comprises moving the probe over the breast tissue to identify an approximate location of the localization device embedded within the breast tissue.
  • Clause 32 The method of any one of clauses 27-31, wherein the at least one RFID signal includes information relating to a depth of the localization device relative to the coil.
  • Clause 33 The method of any one of clauses 27-32, wherein generating an indication of the presence and/or location of the localization device only when a RFID signal transmitted by the localization device embedded within the breast tissue is detected comprises providing an audible indication of a depth of the localization device as the probe is advanced within the incision.
  • a method for locating a localization device embedded in breast tissue comprising: moving a reading device over an area of interest in the breast tissue to identify an approximate location of the localization device embedded within the breast tissue, the reading device including a probe having a coil at a distal end thereof, the coil being configured to transmit a signal resonating at a frequency of the localization device embedded within the breast tissue; forming an incision in the breast tissue adjacent to the location of the localization device; inserting the probe into the incision; receiving electromagnetic signals; determining whether each of the received electromagnetic signals includes a unique identifier; and generating an output for each of the received electromagnetic signals that includes a unique identifier.
  • Clause 37 The method of clause 34, wherein generating the output comprises providing a visual indication of the unique identifier.
  • Clause 38 The method of clause 34, wherein generating the output comprises providing a visual indication of an orientation of the localization device relative to the probe.
  • Clause 39 The method of any one of clauses 34-38, wherein the localization device is an integrated transponder (PIT) tag.
  • PIT integrated transponder
  • spatially relative terms such as “beneath,” “below,” “lower,” “above,” “upper,” “forward,” “front,” “behind,” and the like — may be used to describe one element’s or feature’s relationship to another element or feature as illustrated in the orientation of the figures.
  • These spatially relative terms are intended to encompass different positions and orientations of a device in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is inverted, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features.
  • the exemplary term “below” can encompass both positions and orientations of above and below.
  • a device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

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Abstract

Un procédé de localisation d'une étiquette de transpondeur intégré passif (PIT) incorporée dans un tissu consiste à déplacer un dispositif de lecture par rapport à une zone d'intérêt dans le tissu. Le dispositif de lecture comprend une sonde pourvue d'une bobine au niveau d'une extrémité distale de celle-ci. La bobine est configurée pour transmettre un signal résonant à une fréquence de l'étiquette PIT incorporée dans le tissu. Le procédé consiste également à recevoir un ou plusieurs signaux radiofréquence (RF) avec le dispositif de lecture et à déterminer si au moins l'un des signaux RF est un signal d'identification par radiofréquence (RFID) transmis par l'étiquette PIT incorporée dans le tissu. Le procédé consiste en outre à générer une indication d'une présence et/ou d'un emplacement de l'étiquette PIT uniquement lorsqu'un signal RFID transmis par l'étiquette PIT incorporée dans le tissu est détecté.
PCT/US2024/047247 2023-09-29 2024-09-18 Procédés de localisation d'étiquettes de transpondeurs intégrés passifs, et dispositifs et systèmes les incorporant Pending WO2025072006A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007117478A2 (fr) * 2006-04-05 2007-10-18 Health Beacons, Inc. processus chirurgicaux
US8973584B2 (en) 2009-02-13 2015-03-10 Health Beacons, Inc. Method and apparatus for locating passive integrated transponder tags
US20170007352A1 (en) * 2014-01-24 2017-01-12 Elucent Medical, Inc. Systems and methods comprising localization agents
US20220183585A1 (en) * 2016-08-12 2022-06-16 Elucent Medical, Inc. Surgical device guidance and monitoring devices, systems, and methods

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007117478A2 (fr) * 2006-04-05 2007-10-18 Health Beacons, Inc. processus chirurgicaux
US8973584B2 (en) 2009-02-13 2015-03-10 Health Beacons, Inc. Method and apparatus for locating passive integrated transponder tags
US20150264891A1 (en) * 2009-02-13 2015-09-24 Health Beacons, Inc. Method and apparatus for locating passive integrated transponder tags
US9867550B2 (en) 2009-02-13 2018-01-16 Health Beacons, Inc. Method and apparatus for locating passive integrated transponder tags
US10849529B2 (en) 2009-02-13 2020-12-01 Health Beacons, Inc. Method and apparatus for locating passive integrated transponder tags
US20170007352A1 (en) * 2014-01-24 2017-01-12 Elucent Medical, Inc. Systems and methods comprising localization agents
US20220183585A1 (en) * 2016-08-12 2022-06-16 Elucent Medical, Inc. Surgical device guidance and monitoring devices, systems, and methods

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