Medical positioning system

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

Reexamination Certificate

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Reexamination Certificate

active

06233476

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to positioning systems in general, and to methods and systems for positioning an item within a living tissue, in particular.
BACKGROUND OF THE INVENTION
Minimal Invasive Endoscopic Surgery (MIES) provides the means by which less invasive medical procedures can be employed cost-effectively for a huge segment of the patient population, covering the most important medical specialties and surgical interventions. While patients benefit from this innovative technique, much of the credit for its success must be given to physicians/endoscopists and to manufacturers who created the endoscopic video imaging systems and unique procedure-specific devices, which together made millions of procedures possible each year since the technique gained prominence in the late 1980's.
MIES reduces the cost of the overall procedure by reducing the number of days that a patient spends in a medical facility and by significantly reducing the trauma which is inflicted on the patient, which reduces the chance for complication during a procedure and afterwards.
Systems for determining the location of a medical device within a treated living tissue are known in the art. In general, these systems are divided into two major groups, which are visual systems, semi visual systems and non-visual positioning system.
A conventional visual system includes an optical imaging element such as a fiber optic based device. The imaging element is inserted into the body of the patient and assists the physician in locating any surgical tool therein. One such system is called an endoscope. A conventional endoscope includes a dilating catheter in which lighting means, visual image unit and a surgical tool, are inserted.
Semi-visual systems often include a real time imaging device such as an ultrasound mechanism, which is combined with the tip of the endoscope. An example for such a system is the EUB-525 ultrasound system with the 10R probe, manufactured and sold by Hitachi.
Non visual systems include additional means, which assist the user in determining the location of the medical device within the body of the patient. U.S. Pat. No. 5,729,129 to Acker is directed to a magnetic location system with feedback adjustment of magnetic field generator. It is noted that this system is subjected to metal object interference, which is produced by various metal objects, located in the vicinity of the system. Another disadvantage of this system is that the general method of operation of such a system includes three consecutive steps: transmitting an electromagnetic signal; detecting this signal and adjusting the electromagnetic signal according to the detected one. Hence the refresh rate of this system is significantly slow.
U.S. Pat. No. 5,840,025 to Ben-Haim, is directed to an Apparatus And Method for Treating Cardiac Arrhythmias. According to Ben-Haim, a catheter is inserted into the body of the patient and located in selected locations within the heart. The tip of the catheter includes a transmitting antenna, which transmits an electromagnetic signal. This signal is detected by external antennas and is then used to determine the location of the tip of the catheter. Finally, this information is super imposed on a pre-acquired image of the treated area.
U.S. Pat. No. 5,752,513 to Acker et al is directed to a Method And Apparatus for Determining the Position of an Object. The system uses an electromagnetic transmitter and receiver arrangement to determine the location and orientation of a medical device, which is inserted in the body of a patient. The location and orientation information is incorporated with a pre-acquired image of the treated area, using a plurality of markers, which have both visual as well as magnetic characteristics. It is noted that the accuracy of this apparatus significantly decreases in the presence of metal objects, which deform the magnetic fields.
A Bronchoscope is a specific type of an endoscope, which is directed for treating lungs. During a conventional lung treatment, the physician inserts the bronchoscope into the lung of the patient and operates the surgical tool (which can be a clamp, a brush, a laser device and the like) while viewing the inside volume of the lung, using the visual image unit.
It will be appreciated by those skilled in the art that the width of the bronchoscope is significant. Hence, a bronchoscope can not be used to treat places, where the access thereto is narrower than the diameter of the bronchoscope. In the case of lung treatment, the conventional method is to place the patient on an X-ray table system and place an X-ray video camera on top, which provides continuous images of the treated area and the surgical tool inserted therein. It will be appreciated by those skilled in the art that this method suffers several disadvantages. The imaging resolution is often not high enough and provides only vague indication of the location of the surgical too. Operating an X-ray table requires a medical staff of several people. X-ray based technology is known in the art as inflicting considerable hazards on the medical staff operating it.
Gastroscopy is also known in the art. One type of gastroscopes includes an ultrasound transceiver at the tip end, providing continuous semi-visual information, enabling the physician to operate a surgical tool using this information. It will be appreciated by those skilled in the art that operating an ultrasound-visualizing device requires a considerable training period, which conventionally is in the order of 18-24 months. Such a combined ultrasound gastroscopy system is the FG-34UX model, manufactured and soled by Pentax.
Another type of positioning system includes the UltraGuide 1000, which is a combined ultrasound and magnetic location system. This system includes an external ultrasound transducer and a magnetic field based location detection system, which is mounted on a firm surgical tool, such as a large needle. This ultrasound device enables the user to select an insertion point and angle that permit access, with a long needle, to a target within the body of the patient.
SUMMARY OF THE PRESENT INVENTION
It is an object of the present invention to provide a novel method and system for determining the location and orientation of objects, within a scanning volume, which overcomes the disadvantages of the prior art. It is another object of the present invention to provide a novel method and system for initiating and calibrating the location and orientation of a detector of the system, within the scanned volume.
It is a further object of the present invention to provide a novel method and system for obtaining an inner body three-dimensional image from a plurality of two dimensional images.
It is yet another object of the present invention to provide a novel method and system to operate within the body of the patient, wirelessly.
In accordance with the present invention, there is thus provided an apparatus for determining the position and orientation of a surgical tool relative to a reference frame, in association with an image. The apparatus includes a magnetic field transmitter, a detection probe, a signal generation module, connected to the magnetic field transmitter, a detection processor, connected to the detection probe and mounting means, for mounting onto the surgical tool.
The magnetic field transmitter, includes at least one magnetic field generating element. The detection probe includes at least one magnetic field detector
The combined number of the magnetic fields generators and the magnetic field detectors is at least four. The signal generation module determines a transmit signal and provides the transmit signal to the magnetic field transmitter. The detection processor receives a detected signal from the detection probe, determines the location and orientation of the detection probe from the detected signal and indicates the location of the surgical tool within the image. The detection probe can include any number of magnetic field detectors.
The signal generation module can include a

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