Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-03-26
2003-09-30
Vo, Hieu (Department: 3747)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C324S318000
Reexamination Certificate
active
06628980
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates in general to magnetic resonance imaging (MRI), and in particular to devices for in vivo MRI.
2. Related Art
Minimally invasive surgical techniques often involve introducing a medical device e.g. an endoscope in any body lumen (natural or man-made) to provide an optical view of anatomy of interest. Surgical tools such as biopsy needles, incision/suturing devices, etc are used under optical guidance of the endoscope. The limitation of this technique is that the field of view (FOV) is limited in front of the device, in some cases by the end of the cavity. In particular, nothing can be seen beyond the surface of the tissue surrounding the endoscope. This poses a limitation for the operating surgeon, limiting the efficacy of the procedure. One approach to circumvent this problem is to employ imaging systems relying on signals other than visible light to generate an image of surrounding tissue. One such system is magnetic resonance imaging (MRI).
MRI is a well known, highly useful technique for imaging matter. It has particular use with imaging the human body or other biological tissue without invasive procedures or exposure to the harmful radiation or chemicals present with x-rays or CT scans. MRI uses changes in the angular momentum or “spin” of atomic nuclei of certain elements to show locations of those elements within matter. In an MRI procedure, a subject is usually inserted into an imaging machine that contains a large static magnetic field generally on the order of 0.2 to 4 Tesla although machines with higher and lower strength fields are being developed and used. This static magnetic field tends to cause the vector of the magnetization of the atomic nuclei placed therein to align with the magnetic field. The subject is then exposed to pulses of radio frequency (RF) energy in the form of a second, oscillating, RF magnetic field having a particular frequency referred to in the art as a resonant or Larmor frequency. This frequency is equal to the rate that the spins rotate or precess.
This second field is generally oriented so that its magnetic field is oriented in the transverse plane to that of the static magnetic field and is generally significantly smaller. The second field pulls the net magnetism of the atomic nuclei off the axis of the original magnetic field. As the second magnetic field pulses, it pulls the spins off axis. When it is turned off, the spins “relax” back to their position relative to the initial magnetic field. The rate at which the spins relax is dependent on the molecular level environment. During the relaxation step, the precessing magnetization at the Larmor frequency induces a signal voltage that can be detected by antennas tuned to that frequency. The magnetic resonance signal persists for the time it takes for the spins to relax. Since different tissues have different molecular level environments, the differences in relaxation times provides a mechanism for tissue contrast in MRI. The magnetic resonance signal is detected in the form of a voltage that the precessing magnetization induces in an antenna placed nearby.
In order to image the magnetic resonance signal it is necessary to encode the locations of the resonant spins. This is performed by applying pulses of gradient magnetic fields to the main magnetic field in each of the three dimensions. By creating these fields, the location of resonant nuclei can be determined because the nuclei will resonate at a different Larmor frequencies since the magnetic field they experience differs from their neighbors. The magnetic resonance (MR) image is a representation of the magnetic resonance signal on a display in two or three dimensions. This display usually comprises slices taken on an axis of interest in the subject, or slices in any dimension or combination of dimensions, three-dimensional renderings including computer generated three-dimensional “blow-ups” of two-dimensional slices, or any combination of the previous, but can comprise any display known to the art.
MR signals are very weak and therefore the antenna's ability to detect them depends on both its size and its proximity to the source of those signals. In order to improve the signal of an MRI, the antenna may be placed near or inside the subject to be imaged. Such improvements can enable valuable increases in resolution sensitivity and reduction of scan time. It may be desirable to have evidence of the MRI antenna itself on the MRI image to allow the individual inserting the MRI antenna to direct where it is going and to maneuver it with aid from the MR image. Such a benefit could be useful in medical procedures where MRI is used simultaneously to track the position of an intraluminal device and to evaluate the structures surrounding the lumen. For example, an intravascular catheter could be directed through a vessel using MRI to reach a targeted area of the vessel, and the MRI apparatus could further be used to delineate the intravascular anatomy or nearby tissue to determine whether a particular therapeutic intervention would be required. Using MRI to guide the catheter and using MRI further to map out the relevant anatomy could complement conventional angiographic imaging technology within an interventional radiology or cardiology or minimally invasive imaging suite. Once the catheter is directed to the desired anatomic target under MR guidance, and once the topography or other relevant anatomy of the target lesion is depicted using MRI, the clinician can make decisions about what type of intervention would be indicated, if any, and where the intervention should be delivered.
Many conventional vascular interventional procedures use X-ray imaging technology in which guidewires and catheters are inserted into a vein or artery and navigated to specific locations in the heart for diagnostic and therapeutic procedures. Conventional X-ray guided vascular interventions, however, suffer from a number of limitations, including: (1) limited anatomical visualization of the body and blood vessels during the examination, (2) limited ability to obtain a cross-sectional view of the target vessel, (3) inability to characterize important pathologic features of atherosclerotic plaques, (4) limited ability to obtain functional information on the state of the related organ, and (5) exposure of the subject to potentially damaging x-ray radiation.
MRI techniques offer the potential to overcome these deficiencies. However, many conventional intraluminal tools are not suitable for use in MRI machines since they contain steel or magnetic materials that can cause significant image artifacts in an MRI machine and can cause injury to a patient from unintended motion due to effects of the magnetic fields or induced Ohmic heating. Additionally, intraluminal devices made of non-magnetic materials (e.g., polymers) cannot easily be visualized by MRI. Even those antennae which have been fabricated for use inside a human body are not useful for many types of interventional procedures. Many of these devices are simply too large to be sufficiently miniaturized to allow the placement of an interventional device simultaneously with the antenna in a small vessel without causing injury to the subject. Furthermore, many of these devices are not useful because the antenna cannot work in conjunction with the range of interventional tools that are widely used in many types of procedures due to space and design considerations of the antenna. Such devices include, but are not limited to, such tools as balloon catheters for dilatation angioplasties, for stent placements, for drug infusions, and for local vessel therapies such as gene therapies; atherotomes and other devices for plaque resection and debulking; stent placement catheters; drug delivery catheters; intraluminal resecting tools; electrophysiologic mapping instruments; lasers and radio frequency and other ablative instruments. Conventional antennas fail in this regard because they have no method for allowing the loading and use of these devic
Atalar Ergin
Bottomley Paul A.
Karmarkar Parag
Lardo Albert C.
Zerhouni Elias
Foley & Hoag LLP
Surgi-Vision, Inc.
Vo Hieu
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