Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-02-15
2003-02-04
Walberg, Teresa (Department: 3742)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S410000
Reexamination Certificate
active
06516213
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to methodology and apparatus to determine the location and orientation of an object, for example a medical device, located inside or outside a body, while the body is being scanned by magnetic resonance imaging (MRI). More specifically, the invention enables estimation of the location and orientation of various devices(e.g. catheters, surgery instruments, biopsy needles, etc.) by measuring voltages induced by time-variable magnetic fields in a set of miniature coils. Such time-variable magnetic fields are generated by an MRI scanner during its normal operation.
BACKGROUND OF THE INVENTION
Minimally invasive procedures: Minimally-invasive diagnostic or interventional procedures require either direct visual viewing or indirect imaging of the field of operation and determination of the location and orientation of the operational device. For example, laparoscopic interventions are controlled by direct viewing of the operational field with rigid endoscopes, while flexible endoscopes are commonly used for diagnostic and interventional procedures within the gastrointestinal tract. Vascular catheters are manipulated and manoeuvred by the operator, with real-time X-ray imaging to present the catheter location and orientation. Ultrasound imaging and new real-time MRI and CT scanners are used to guide diagnostic procedures (e.g. aspiration and biopsy) and therapeutic interventions (e.g. ablation, local drug delivery) with deep targets. While the previous examples provide either direct (optical) or indirect (imaging) view of the operation field and the device, another approach is based on remote sensing of the device with mechanical, optical or electromagnetic means to determine the location and orientation of the device inside the body.
Stereotaxis: Computer-assisted sterotaxis is a valuable technique for performing diagnostic and interventional procedures, most typically with the brain. The concept behind the technique is to have real-time measurement of the device location in the same coordinate system as an image of the field of operation. The current location of the device and its future path are presented in real-time on the image and provide the operator with feed-back to manipulate the device with minimal damage to the organs. During traditional sterotaxis, the patient wears a special halo-like headframe, which provides the common coordinate system, and CT or MRI scans are performed to create a three-dimensional computer image that provides the exact location of the target (e.g. tumour) in relation to the headframe. The device is mechanically attached to the frame and sensors provide its location in relation to the head frame. When this technique is used for biopsy or minimally-invasive surgery of the brain, it guides the surgeon in determining where to make a small hole in the skull to reach the target. Newer technology is the frameless technique, using a navigational wand without the headframe (e.g. Nitin Patel and David Sandeman, “A Simple Trajectory Guidance Device that Assists Freehand and Interactive Image Guided Biopsy of Small Deep Intracranial Targets”, Comp Aid Surg 2:186-192, 1997). In this technique remote sensing system (e.g. light sources and sensors) provides the real-time location of the device with respect to the image coordinate system. Yet both the sterotaxis and the frameless techniques are typically limited to the use of rigid devices like needles or biopsy forceps since their adequate operation requires either mechanical attachments or line of sight between the light sources and the sensors.
Electromagnetic remote sensing: Newer remote sensing techniques are based on electromagnetism. For example, Acker et al (U.S. Pat. No. 5,558,091) disclose such a method and apparatus to determine the position and orientation of a device inside the body. This method uses magnetic fields generated by Helmholtz coils, and a set of orthogonal sensors to measure components of these fields and to determine the position and orientation from these measurements. The measurement of the magnetic field components is based on Hall effect and requires exciting currents in the sensors in order to generate the measured signals. The technique requires control of the external magnetic fields and either steady-state or oscillating fields, for the induced voltages to reach a state of equilibrium. These requirements prevent, or greatly complicate, the use of this technique with magnetic fields generated by the MRI system, and requires the addition of a dedicated set of coils to generate the required magnetic fields.
A different approach for remote sensing of location is disclosed by Pfeiler et al. (U.S. Pat. No. 5,042,486) and is further used by Ben-Haim for intra-body mapping (U.S. Pat. No. 5,391,199). Their technology is based on generating weak radio-frequency (RF) signals from three different transmitters, receiving the signals through an RF antenna inside the device, and calculating the distances from the transmitters, which define the spatial location of the device. As with the previous methodology, the application of the technology to MRI is problematic due to the simultaneous use of RF signals by the MR scanning. Potential difficulties are the heating of the receiving antenna in the device by the high amplitude excitation RF transmissions of the MRI scanner and artifacts in the MR image.
Dumoulin and colleagues disclose another approach to determine the location of a device, using a small receiving coil which is sensitive to near-neighbourhood emitted RF signal during the MR imaging process (Dumoulin C L, Darro R D, Souza S P, “Magnetic resonance tracking”, in Interventional MR, edited by Jolesz F A and Young I Y, Mosby, 1998). This method cannot directly determine the orientation of the device, and may be subject to similar difficulties as the previous technology, including heating of the coil.
Interventional MRI: Many of the advantages of MRI that make it a powerful clinical imaging tool are also valuable during interventional procedures. The lack of ionizing radiation and the oblique and multi-planar imaging capabilities are particularly useful during invasive procedures. The absence of beam-hardening artifacts from bone allows complex approaches to anatomic regions that may be difficult or impossible with other imaging techniques such as conventional CT. Perhaps the greatest advantage of MRI is the superior soft-tissue contrast resolution, which allows early and sensitive detection of tissue changes during interventional procedures. Many experts now consider MRI to be one of the most powerful imaging techniques to guide interventional interstitial procedures, and in some cases even endovascular or endoluminal procedures (Yoshimi Anzai, Rex Hamilton, Shantanu Sinha, Antonio DeSalles, Keith Black, Robert Lufkin, “Interventional MRI for Head and Neck Cancer and Other Applications”, Advances in Oncology, May 1995, Vol 11 No. 2).
From the present background on current methodologies, one can define the ideal system for minimal invasive procedures: It should provide real-time, 3-dimensional, non-ionizing imaging (like MRI or ultrasound) as feed-back to the user for optimal insertion and intervention; it should implement flexible, miniaturized devices which are remotely sensed to provide their location and orientation. By combining a composite image of the field of operation and the device location and orientation, the operator can navigate and manipulate the device without direct vision of the field of operation and the device. This may facilitate the use of minimal invasive intervention in the brain or other organs.
OBJECTS AND SUMMARY OF THE INVENTION
An object of the present invention is to provide a novel method and apparatus for determining the instantaneous location and orientation of an object moving through a three-dimensional space, which method and apparatus have advantages in one or more of the above respects.
Another object of the present invention is to provide such a method and apparatus which is particularly useful in MRI syste
Robin Medical Inc.
Van Quang
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