WO2015187857A1 - Suivi de dispositif médical au moyen d'un réseau de capteurs à base de rf - Google Patents

Suivi de dispositif médical au moyen d'un réseau de capteurs à base de rf Download PDF

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Publication number
WO2015187857A1
WO2015187857A1 PCT/US2015/034031 US2015034031W WO2015187857A1 WO 2015187857 A1 WO2015187857 A1 WO 2015187857A1 US 2015034031 W US2015034031 W US 2015034031W WO 2015187857 A1 WO2015187857 A1 WO 2015187857A1
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WIPO (PCT)
Prior art keywords
tag
sensor array
antenna
reader
subject
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PCT/US2015/034031
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English (en)
Inventor
Ahmad Abiri
Alan PRIESTER
Parinaz ABIRI
Rudy RUMMEL
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The Regents Of The University Of California
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Publication of WO2015187857A1 publication Critical patent/WO2015187857A1/fr

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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 probes within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/064—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/12—Devices for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/46—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment with special arrangements for interfacing with the operator or the patient
    • A61B6/461—Displaying means of special interest
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/48—Diagnostic techniques
    • A61B6/486—Diagnostic techniques involving generating temporal series of image data
    • A61B6/487—Diagnostic techniques involving generating temporal series of image data involving fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/54—Control of apparatus or devices for radiation diagnosis
    • A61B6/547—Control of apparatus or devices for radiation diagnosis involving tracking of position of the device or parts of the device
    • 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
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • 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
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • 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
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
    • A61B2505/05—Surgical care

Definitions

  • Magnetic tracking has been used in wide variety of applications across many industries. Direct application of magnetic fields for collecting position and orientation data often results in expensive and lengthy product development due to the complex task of developing custom sensors, transmitters and shielding technology. This fact often forces the price of these systems far above industry average.
  • the existence of powerful magnets in devices such as MRI introduces another concern when developing custom magnetic tracking systems. Further, better visualization is needed when an inserted device (i.e., a catheter) is moving under some tissue types and when navigating very small vessels.
  • CVD cardiovascular disease
  • IC interventional cardiology
  • IR interventional radiology
  • fluoroscopy-based catheter visualization is often challenging even with the use of radiopaque markers.
  • Contrast-induced acute kidney injury occurs in 2- 25% of all patients undergoing coronary intervention and is associated with poor short and long-term outcomes (Soloman, R., and Dauerman, H.L., "Contrast-induced acute kidney injury,” Circulation, vol.
  • CI-AKI has many common comorbidities with other conditions that often result in catheterization procedures, including diabetes mellitus, congestive heart failure, myocardial infarction, and chronic kidney disease
  • diabetes mellitus congestive heart failure
  • myocardial infarction myocardial infarction
  • chronic kidney disease Mehran R, et al., "A simple risk score for predication of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation.” J. Am Coll Cardiol. 2004; 44: 1393-1399; Brown J. et al, "Transient and persistent renal dysfunction are predictors of survival after percutaneous coronary intervention: insights from the Dartmouth Dynamic Registry.” Catheter Cardiovasc. Interv. 2008; 72:347-354).
  • These interrelated disease processes create serious
  • a system for detecting the position and orientation of an implantable or insertable device includes an implantable or insertable device, at least one RF tag attached to the device, a sensor array, wherein the sensor array comprises at least one RF reader and a plurality of antennas, a digital display, and a control unit communicatively connected to the sensor array and the digital display, wherein when the control unit receives a signal from the sensor array that at least one of the antennas has detected the at least one RF tag, the control unit transmits data indicative of the position or orientation of the device to the digital display.
  • the implantable or insertable device is a catheter, a needle, a tube, a stent, a wire, a lead, a surgical tool, an implanted pump, a pacemaker, a defibrillator or a probe.
  • the at least one RF reader or external power supply delivers power to the at least one RF tag.
  • the sensor array is positioned external to a subject.
  • the sensor array is positioned on or in an operating table.
  • the control unit further comprises an algorithm that samples at least one antenna of the antenna array to determine which antenna of the array receives a signal emitted by the at least one RF tag.
  • the sensor array comprises one or more radiopaque markers.
  • the position of the device is reported with less than a 4 mm error. In another embodiment, the position of the device is reported at a rate of at least 5 frames per second. In another embodiment, the sensor array is multilayered. In another embodiment, the sensor array is integrated into a mat. In another embodiment, the sensor array is attached to or integrated within a wearable garment. In another embodiment, the device is detected in real time.
  • the method includes the steps of implanting or inserting a device into a subject, wherein the device includes at least one RF tag, positioning a sensor array external to the subject, wherein the sensor array includes at least one RF reader an a plurality of antennas, receiving at least one RF tag detection signal from at least one antenna at the RF sensor array, and determining the position of the device within the subject based on the at least one received signal at the RF reader.
  • the method further comprises modulating the signal amplification for the at least one antenna receiving the at least one RF tag detection signal until the RF tag detection signal disappears, thereby generating data indicative of the Z-position of the device RF tag.
  • the method further comprises displaying data indicative of the location of the RF tag overlaid on a fluoroscopy image or other imaging modality (such as MRI or CT), of the region of the subject where the device is implanted or inserted.
  • the method further comprises sampling at least one antenna to determine which antenna receives a signal emitted by the at least one RF tag.
  • the method further comprises reporting the position of the device with less than a 4 mm error.
  • the method further comprises reporting the position of the device at a rate of at least 5 frames per second.
  • the method further comprises wirelessly powering the at least one RF tag via the at least one RF reader.
  • FIG. 1 is a schematic depicting an exemplary clinical layout of the system of the present invention.
  • Figure 2 is a schematic depicting an exemplary integrated circuit (such as an RFID tag) and antenna positioned on a medical device (such as a catheter) for insertion into a subject.
  • a medical device such as a catheter
  • Figure 3 is a schematic of an exemplary sensor array positioned external to the subject.
  • Figure 4 is an exemplary image depicting the real-time tracking of an RF tag, displaying the current and past locations of the tag.
  • Figure 5 and Figure 6 are schematics depicting an example of how the activated antenna, corresponding to the antenna that receives a signal from the implanted RF tag, is used to determine the position of the RF tag.
  • Figure 7 is a schematic depicting the exemplary use of the activated antennas to determine orientation.
  • Figure 8 is a chart depicting the mean tag position error verses the number of detecting antennas.
  • Figure 9 is a photograph of an exemplary prototype of a system of the present invention.
  • ranges throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.
  • the present invention provides systems and methods for the real-time detection of an implanted or inserted medical device in a subject.
  • the invention allows for the non-ionizing tracking of a medical device during the course of a medical or clinical procedure.
  • the invention may be used to provide a clinician with a real-time view of the location of an implanted or inserted medical device used in a procedure.
  • the invention allows for the tracking of the position of an implanted medical device within the subject over time.
  • the invention may be used to monitor the position of the device over minutes, hours, days, weeks, months, years, and the like.
  • System 100 may be located or utilized in a designated area 101, such as an operating room, for use in a procedure performed on a subject 105.
  • System 100 may generally include a device 110, such as a catheter, which includes an integrated circuit (IC) tag 120 positioned thereon near the leading tip of catheter 110.
  • IC integrated circuit
  • System 100 further includes a sensor array 140, which may be positioned on a table 130 underneath subject 105 during the procedure.
  • System 100 further includes a digital display 150 and a control unit 170 for receiving signals from sensor array 140, processing data and transmitting to digital display 150 for an audio and/or visual presentation of tracking imagery 160. Accordingly, system 100 may be used to detect device 110 as it is guided through the body in real time. System 100 is particularly designed and suited to track medical devices, such as catheters, inside the body in a cost- effective manner, while minimizing radiation exposure and improving visualization (e.g. in interventional radiology procedures).
  • Device 110 may be any type of device, including, but not limited to, catheters, needles, tubes, stents, wires, leads, surgical tools, implanted pumps, pacemakers, defibrillators, probes, and the like. Accordingly, the systems and methods described herein are not limited to the tracking of any particular device or class of devices, but rather may be used to track any device 110 capable of having an IC tag attached to or integrated therewith.
  • device 110 is a catheter. Any size catheter may be used in with system 100. For example, in certain embodiments, the catheters tracked by way of the invention are 2-20Fr catheters.
  • IC tag 120 may be any type of IC tag understood in the art that can be detected wirelessly.
  • system 100 is a radio-frequency (RF) based system
  • IC tag 120 may be an RF tag, such as an RFID tag.
  • tag 120 may further include a microchip 122 and an antenna 124 attached to the implantable or insertable device 110.
  • tag 120 may additionally include any desired logic unit, memory unit, a data transmission unit, and any other desired component suitable for an IC tag as would be understood by those skilled in the art.
  • tag 120 may include a power source, or be powered by associated device 110, tag 120 is preferably passive— that is, it does not have a local power source.
  • tag 120 is powered wirelessly, such as through electromagnetic induction or other wireless powering mechanisms. In such embodiments, the lack of an internal battery allows tag 120 to be extremely small. When tag 120 is an RF tag, its small size makes it ideal for placement at the tip of devices such as surgical tools and/or catheters. In other embodiments, tag 120 may be actively powered, or powered via a wired mechanism. For example, if tag 120 is integrated with device 110, tag 120 may be powered by a power source associated with device 110. The availability of small RF tags allows for easier and cheaper product development, while the existence of openly available circuit designs simplify pre -manufacturing optimization.
  • Tag 120 may be attached to device 110 using any known technique.
  • device 110 may be manufactured with an integrated tag 120 and/or antennas attached, or tag 120 and/or antenna may be separately attached to a third-party catheter.
  • Tag 120 and antenna may be attached anywhere on device 110.
  • tag 120 and antennas may be attached at the distal tip, within the inner lumen, along the outer surface, and/or anywhere along the catheter length.
  • tag 120 is an RF tag
  • tag 120 once powered through electromagnetic induction, generates a uniquely identifiable RF signal that may be detected using system components described elsewhere herein and as would be understood by those skilled in the art.
  • sensor array 140 may include one or more antennas 142, and one or more receivers 144, for example, RF readers.
  • antennas 142 may include one or more antennas 142, and one or more receivers 144, for example, RF readers.
  • receivers 144 for example, RF readers.
  • the one or more receivers 144 generate the signals necessary to inductively power tag 120, and further receives the subsequently generated tag signal.
  • the detection range of receiver 1444 can depend on a number of factors, such as the size of antenna 124 of tag 120, the power output of the one or more antennas 142 of receiver 144, and local interference.
  • the outgoing and/or incoming signals may be dynamically amplified using standard or custom circuitry.
  • the one or more receivers 144 are connected to a series of multiplexers, which route their signals through the antenna array, described elsewhere herein. It should be appreciated that sensor array 140 may include any other additional components for sending/receiving, powering, amplifying and the like, as would be understood by those skilled in the art.
  • sensor array 140 may take the form of a reusable or disposable mat 148 that includes an antenna array which is connected, via multiplexers (not shown), to the one or more receivers 144.
  • Antennas 142 within mat 148 may be laid out in any spacing and configuration suitable for the application desired.
  • antennas 142 may have substantially uniform spacing in a grid-like configuration. The antenna array allows for the use of fewer receivers, thereby reducing the cost of the present system.
  • sensor array 140 may be multilayered. There is no limitation to the number of sensor array layers, or to a particular spacing or pattern in any given layer. In another embodiment in which sensor array 140 includes a large number of receivers, communication between the receiver 144 and tag 120 may occur through one antenna.
  • system 100 may employ an array of antennas laid out on a support structure. Further, by employing the use of a multiplexer that can sweep through the antennas, a small number of high performance receivers can simulate a complete array. The temporal performance of the system can thus be optimized by increasing scanning frequency or the number of receivers. As contemplated herein, detection latency, along with a number of other data elements, can be used to improve the performance and resolution of system 100 without increasing sensor array antenna density.
  • a microcontroller interfaces with the multiplexers and antenna array, and cycles through them in order to localize the tag's incoming signal.
  • sensor array 140 may be constructed on a substrate, which is positioned external to the subject having the inserted or implanted medical device.
  • sensor array 140 is positioned on or in an operating table, beneath the patient, as shown in Figure 1.
  • the sensor array may be positioned on or in a garment configured to be worn by the patient.
  • the array can be attached directly to a fluoroscopy unit, or located anywhere in the room, such as on a wall or other surface.
  • Digital display 150 may be any computing or thin client device capable of receiving and displaying audio and visual data and images corresponding to the detected IC tag.
  • digital display 150 may be a monitor, a television, a smartphone, a tablet or any other digital display screen suitable for presenting audio and visual data or other information.
  • digital display 150 may include multiple displays that show the same or different images received from control unit 170.
  • digital display 150 may be a computing device capable of receiving signals directly from sensor array 140 reader components.
  • Control unit 170 may be one or more computing devices which run the software and algorithm described elsewhere herein. Exemplary computing devices include, but are not limited to, a computer, desktop, laptop, tablet, phone, and the like. The computing devices may include at least one processor, standard input and output devices, as well as all hardware and software typically found on computing devices for storing data and running programs, and for sending and receiving data over a network. Control unit 170 may be connected to sensor array 140 components and digital display 150 via a communications network, and thus receives signals from sensor array 140, processes data and transmits to digital display 150 for audio and visual presentation of tracking imagery 160.
  • the software running on or by system 100 may include a software framework or architecture that optimizes ease of use of at least one existing software platform, and that may also extend the capabilities of at least one existing software platform.
  • the software provides applications accessible to one or more users (e.g. patient, clinician, etc.) to perform one or more functions. Such applications may be available at the same location as the user, or at a location remote from the user.
  • Each application may provide a graphical user interface (GUI) for ease of interaction by the user with information resident in the system.
  • GUI graphical user interface
  • a GUI may be specific to a user, set of users, or type of user, or may be the same for all users or a selected subset of users.
  • the system software may also provide a master GUI set that allows a user to select or interact with GUIs of one or more other applications, or that allows a user to simultaneously access a variety of information otherwise available through any portion of the system.
  • the GUI may display information regarding the historical or real-time tracking of the IC tagged device.
  • Presentation of data through the software may be in any sort and number of selectable formats. For example, a multi-layer format may be used, wherein additional information is available by viewing successively lower layers of presented information. Such layers may be made available by the use of drop down menus, tabbed pseudo manila folder files, or other layering techniques understood by those skilled in the art.
  • the software may also include standard reporting mechanisms, such as generating a printable results report, or an electronic results report that can be transmitted to any communicatively connected computing device, such as a generated email message or file attachment.
  • standard reporting mechanisms such as generating a printable results report, or an electronic results report that can be transmitted to any communicatively connected computing device, such as a generated email message or file attachment.
  • particular results of the aforementioned system can trigger an alert signal, such as the generation of an alert email, text or phone call, to alert a patient, doctor, nurse, emergency medical technicians, or other health care provider of the particular results.
  • data is transferred from sensor array 140, control unit 170, and digital display 150 using either wired or wireless communication.
  • Wireless communication for information transfer to and from system 100 components may be via a wide area network and may form part of any suitable networked system understood by those having ordinary skill in the art for communication of data to additional computing devices, such as, for example, an open, wide area network (e.g., the internet), an electronic network, an optical network, a wireless network, a physically secure network or virtual private network, and any combinations thereof.
  • Such an expanded network may also include any intermediate nodes, such as gateways, routers, bridges, internet service provider networks, public-switched telephone networks, proxy servers, firewalls, and the like, such that the network may be suitable for the transmission of information items and other data throughout system 100.
  • data transfer can be made via any wireless communication and may include any wireless based technology, including, but not limited to radio signals, near field communication systems, hypersonic signal, infrared systems, cellular signals, GSM, and the like.
  • data transfer is conducted without the use of a specific network. Rather, in certain embodiments, data is directly transferred to and from the system 100 components.
  • system 100 includes software designed to sample antennas 142 of sensor array 140 to receive the tag 120 signal.
  • the software uses the signals to interpret the 2D and 3D location of the implanted or inserted device 110.
  • the software runs an algorithm to continually evaluate the position of device 110.
  • the algorithm and software activates various parts of sensor array 140 to detect tag 120 position, while simultaneously ensuring that tag 120 discharge time does not cause a limitation on the refresh rate.
  • device 110 location is displayed on digital display 150 as imagery 160.
  • data indicative of device 110 location is overlayed on a fluoroscopy image, MR image, CT image, or the like.
  • the data is displayed over a static image.
  • the data is displayed overlaid on a stream of images or a repeated loop of images.
  • the data may be co-registered with other forms of imaging data to provide a clinician with an accurate visual representation of device 110 location.
  • the system may be used with any imaging modality understood by those skilled in the art, including fluoroscopy, MRI and CT imaging.
  • radiopaque markers necessary for co-registration are integrated on sensor array 140.
  • the radiopaque markers on sensor array 140 can be used to co- register tracking data over existing fluoroscopy frames.
  • the current 162 and past 164 locations can be simultaneously displayed, as shown in Figure 4.
  • the X,Y position of device 110 may be calculated using the number and location of antennas 142 that received a signal from tag 120, as shown in Figure 5 and Figure 6. For example, the 2D tracking is achieved by averaging over antennas 142 that detect the position of tag 120. In certain aspects, the strength of received signals over antennas 142 may be used to determine position. In general, as the number of antennas 142 that detect tag 120 increases, the resolution improves.
  • the Z-position of device 110 may be calculated by modulating the level of signal amplification for the antenna 142 directly underneath it, decreasing power until tag 120 signal disappears. Alternatively, one can calibrate the number of detecting antennas 142 with power to determine Z- position.
  • the amplification level of the last detected signal is associated with a discreet height above the antenna array, according to previously performed calibrations. Power modulation, also allows for improvement of the resolution by increasing the transmission power of the array. Additional data such as time for tag detection, phase shift between signals received by different antennas, and number of bits of error are used to
  • System 100 can report device position with less than 2 mm error, and at a rate of at least 5 frames per second. In other embodiments, the system can report device position with less than 4 mm error.
  • the tag position error of system 100 as it relates to the number of detecting antennas is depicted in Figure 8.
  • a few seconds of fluoroscopy footage may be taken, with fiducials visible on the patient and sensor array 140. Fluoroscopy can remain off during the rest of the procedure, and the pre-procedure footage is looped and synced with the patient's movements.
  • the catheter position is overlaid on this footage, displaying its location in real time relative to patient anatomy as shown in imagery 160 of Figure 1.
  • This real-time tracking system can have a significant impact in the treatment of cardiovascular disease, and is applicable to virtually all catheter-based procedures. Enhanced visibility of the catheter in real time can improve safety and minimize patient hospital stay by eliminating errors. Improved tracking will also substantially reduce procedure length and operating room time. Additionally, the substantial reduction in radiation exposure (from minutes or hours down to seconds) can help pregnant patients, those undergoing multiple procedures, or those with compromised immune systems. Furthermore, the reduction in use of fluoroscopy contrast agents will lower costs and reduce the risk of acute tubular necrosis (Soloman, R., and Dauerman, H.L., "Contrast-induced acute kidney injury,” Circulation, vol. 122, pp. 2451-2455, 2010).
  • fluoroscopy is the current standard of care, it has several fundamental weaknesses that can be addressed by system 100.
  • System 100 provides clear visualization of the catheter, superimposed on patient anatomy, as shown in imagery 160 of Figure 1.
  • physicians are often obliged to perform tasks blindly, with only intermittent fluoroscopy footage.
  • catheter localization using system 100 is inherently real-time and available for the entire procedure's duration, thereby greatly reducing error risk, operating room time, and costs.
  • extreme renal toxicity of the contrast dye required by fluoroscopy can be minimized with system 100, requiring approximately 25mL of contrast prior to the procedure (compared to >100mL in DVT therapy and PCIs). This can address a major problem for patients at risk for kidney disease or with compromised renal function, since conventional fluoroscopy often requires contrast dye to be injected multiple times.
  • System 100 is also capable of providing clinicians with features never before offered by existing technologies, including tracking of multiple targets, 3D visualization, and real-time orientation. Although some existing systems claim to have 3D tracking capabilities, no product has effectively accomplished this functionality. In addition, existing systems do not have the ability to compute orientation data, while system 100 has been designed to provide this information intrinsically.
  • the 3D tracking and 3D orientation features can dramatically improve visualization in difficult procedures that involve convoluted vasculature, at vessel bifurcations, and in regions where 2D views result in vessel foreshortening.
  • an exemplary prototype of system 100 was manufactured using commercially available parts. The result was a hand-built, low resolution array that was able to track a 2mm RF tag.
  • the sensory array included 8 antennas and 1 RF reader (2 frames/second), RS232 Interface (9600 bps). Each antenna was 10mm inner-diameter, 40mm outer diameter, and 1mm in height.
  • the system was operating at 125kHz, and no attenuation was observed through the body.
  • the refresh rate was 300ms. With signal amplification, the detection range was able to be increased to a few inches. Operation at a higher frequency, for example, 13.56 MHz, along with improved quality of the circuitry may increase the resolution, the refresh rate and the range.
  • Resolution may be increased by incorporating a multilayer sensor array and/or using machine wound coils using 45 AWG wires, having a 5.03mm outer diameter.
  • the refresh rate may be increased using active discharge, improved scanning algorithms (close-far-close switching), and/or USB/wireless communication interface.
  • a customizable COTS RFID reader supporting ISO/IEC 15693 standard for communication can be integrated with the existing software. This includes communication software to control the RFID reader.
  • the normal detection range for a portable RFID reader is only a few centimeters.
  • an amplification circuitry may be installed between the RFID reader and the transmitting antennas.
  • a high input count multiplexer may also be used to increase resolution and reduce system cost.
  • PCB Printed Circuit Board

Abstract

La présente invention concerne un système et un procédé de suivi non ionisant en temps réel d'un dispositif médical implanté ou inséré. L'invention comprend au moins une étiquette RF fixée sur le dispositif médical et un réseau de capteurs positionné à l'extérieur du sujet, le réseau de capteurs alimentant l'étiquette RF et recevant un signal en provenance de l'étiquette. Des données provenant du réseau de capteurs sont utilisées pour déterminer l'orientation et la position 2D et 3D de l'étiquette RF.
PCT/US2015/034031 2014-06-03 2015-06-03 Suivi de dispositif médical au moyen d'un réseau de capteurs à base de rf WO2015187857A1 (fr)

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CN110072464A (zh) * 2016-12-12 2019-07-30 皇家飞利浦有限公司 用于超声跟踪的无源和有源传感器
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