Device for high gain and uniformly localized magnetic...

Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation

Reexamination Certificate

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C128S899000

Reexamination Certificate

active

06487437

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to medical devices for the reception of electromagnetic radiation. These devices are used (generally at radio frequencies) to obtain a high gain, uniformly wide field-of-view magnetic resonance image of a localized region within a natural organism (such as within a human). Medical devices may be used in conjunction with such magnetic resonance imaging devices, such as catheters and other devices for delivery of drugs and other therapeutic agents to areas of interest within the body or in an artificial environment.
2. Background of the Art
Throughout this specification, the term MR is used to mean “Magnetic Resonance” and “MR microcoil” is used to denote a magnetic resonance device used for imaging from within a patient. MR coils are conventionally used externally to the body in order to generate MR images, while the MR microcoil may be mounted at the tip of a catheter or other insertion device used commonly to probe the interior of a body so as to provide quick and direct access to the region where imaging is required. It is essential during the course of medical procedures such as image-guided and minimal access surgery, performed within small regions of a patient's anatomy, to be able to visualize the procedure being performed by the surgeon and the neighborhood of the anatomical region being treated surgically. While several methods, including x-ray imaging and fiber optic viewing offer possible alternative means of performing the visualization, magnetic resonance imaging methods are a particularly convenient means of doing this, especially given the highly localized nature of the procedures being performed. Extended x-ray exposures are harmful to the patient, and fiber optic viewing is not well suited either to viewing within small confines or to volume visualization. Both of these limitations may be circumvented by magnetic resonance imaging.
In addition, as described in U.S. patent applications Ser. Nos. 08/857,043 and 08/856,894 filed on May 15, 1997 now U.S. Pat. No. 6,026,316 issued Feb. 15, 2000 and U.S. Pat. No. 6,061,584 issued May 9, 2000, respectively, the use of improved Magnetic Resonance Imaging (MRI) techniques and devices enables a real-time visualization of compositional changes in the molecular composition of small regions within patients. The compositional changes may be caused by delivery of drugs or active chemicals, or by the stimulation of local chemical production by tissues or organs in the patient. MRI can actually enable visualization of minute concentration changes within the body, particularly intracranial regions of the patient.
U.S. Pat. No. 5,271,400 describes a tracking system for the position and orientation of an invasive device within a patient. The device includes a receiver coil and an MR active sample. The receiver picks up magnetic resonance signals generated by the sample. The frequencies are proportional to the location of the coil along the applied field gradients, since the signals are received in the presence of these magnetic field gradients. The system is designed to enable location of the invasive device and enhanced imaging of a region around the invasive device is not a functionality intended for this device.
In MR imaging of blood vessels with an intravascular coil’, J. Mag. Res. Imag., 1992, Vol. 2, pages 421-429, A. J. Martin, D. B. Plewes and R. M. Henkelman describe an opposed solenoid design for an intravascular MR microcoil. This paper describes microcoils made of a pair of helical windings arranged in opposed fashion at the tip of a catheter, shown to be suitable for magnetic resonance imaging purposes. The term “opposed coil” means a coil in which the relative winding of two coil segments is opposite in sense, and the current flow in each opposed coil winds in opposite directions about the coil axis (relative to moving towards or away from the core or axis of the coil). That is, viewing the coils looking down an axis of the core around which the coils are disposed, one will be wrapped clockwise and the other will be wrapped counterclockwise, with a common lead between the two segments. The field-of-view of this coil is roughly cylindrical about the opposed solenoidal windings. The coil is essentially radio frequency insensitive beyond the longitudinal extent of the windings since the magnetic field in this design is squeezed out of the gap between the windings and is only significantly large in a cylindrical region that does not extend too far beyond this gap.
E. Atalar et al. describe a catheter receiver coil in ‘High resolution MRI and MRS by using a catheter receiver coil’,
Mag. Res. Med.,
1996, Vol. 36, pages 596-605. The gain of this coil falls off rapidly with distance from the coil so that noise levels in an image adjusted for the signal may still vary widely across the image. In addition, the gain (signal-to-noise ratio) provided by this design may be significantly improved upon by other means, such as in the invention described herein.
U.S. Pat. No. 5,271,400 describes a tracking system for the position and orientation of an invasive device within a patient. The device includes a receiver coil and an MR active sample. The receiver picks up magnetic resonance signals generated by the sample. The frequencies are proportional to the location of the coil along the applied field gradients, since the signals are received in the presence of these magnetic field gradients.
U.S. Pat. No. 4,572,198 describes a catheter for use with magnetic resonance imaging systems, the catheter including a wound coil for exciting a weak magnetic field at the catheter tip. This construction provides a local distortion of the MR image, yielding an image cursor on the magnetic resonance imaging display.
U.S. Pat. No. 5,964,705 describes an opposed solenoid design for an MR microcoil with helical windings whose pitch varies along the length of the winding with the aim of achieving homogeneity. However, the optimization method given there for finding a suitable pitch variation assumes a ‘sheet current’ distribution of the current along the catheter tip, which may not be realized in practice. Accordingly, the homogeneity of the field produced by the microcoil can be improved by other means, such as the invention described and claimed herein.
In summary, while microcoils for such internal imaging have been described before, the said device here has been designed specifically for very significant homogeneity of the radial magnetic field around the MR microcoil and a concommitant optimal sensitivity and signal strength of the received signal. This tends to provide a uniformly large field-of-view within which the said device provides a strong signal-to-noise ratio that is useful for imaging purposes.
A copending, commonly assigned application, filed the same day as this application, U.S. Ser. No. 09/532,037, in the name of Raju Viswanathan, titled A Microcoil Device with a Forward Field-of-View for Large gain Magnetic Resonance Imaging” describes a microcoil configuration wherein a device to be inserted into a patient comprises a solid body having at least one microcoil physically associated with the solid body, each microcoil having an outside microcoil diameter of 6 mm or less and a common axis, with at least one microcoil physically associated with the solid body at a distal end, at least 50% of individual windings of said each microcoil intersecting a geometric plane perpendicular to said common axis.
BRIEF DESCRIPTION OF THE INVENTION
A microcoil configuration, preferably on a medical device to be inserted into a patient, has an opposed pair of microcoils. At least one or each microcoil of the opposed pair of microcoils has at least a region where a diameter circumscribed by a first winding is greater than the diameter circumscribed by at least one complete second winding, especially an adjacent winding displaced from the first winding along an axis or core of the medical device or an axis of the microcoil. The second winding is nearer to or farther fro

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