Communications: electrical – Continuously variable indicating – Via radiant energy beam
Reexamination Certificate
1999-05-21
2001-05-29
Horabik, Michael (Department: 2635)
Communications: electrical
Continuously variable indicating
Via radiant energy beam
C340S870070, C340S573100, C340S010340, C340S870030, C128S903000, C607S032000, C607S060000, C600S301000
Reexamination Certificate
active
06239724
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a system and method for positioning a medical instrument and/or directing a medical procedure within a patient's body. More particularly, the present invention relates to an internal power source free transponder, transplantable within the body, which, in response to a positioning field signal, relays a locating signal outside the body, thereby enabling the precise localization of the transponder within the patient's body.
Various medical procedures require precise localization of the three-dimensional position of a specific intra body region in order to effect optimized treatment.
For example, localization and sampling of a suspected tumor is effected in breast biopsy procedures, by typically using a system known as a core biopsy system. The core biopsy system first obtains a stereo-mammogram from a patient's breast, while the breast is immobilized by being compressed between two plates. The stereo-mammogram is used to calculate the three dimensional (3D) coordinates of the suspected tumor. A needle is then fired into the breast and a biopsy of the suspected tumor is aspirated. If the biopsy is positive, the patient is scheduled for a tumor removal surgery. It should be noted that before the biopsy procedure is commenced, the tumor needs to be manually identified by a physician.
Following biopsy of the tumor the surgical procedure, if necessary, generally proceeds in the following manner. The patient undergoes multi-plane mammography, a radiologist examines the film, and then inserts a wire into the breast so that it punctures the tumor. This procedure is visualized using repetitive x-ray imaging or preferably stereotactic breast imaging systems which can localize the tumor more precisely and assist in the insertion of the wire. The surgeon then cuts the breast open, following the wire until the tumor is found and excised.
Although utilizing the core biopsy system along with surgery is currently the method of choice when dealing with breast cancers and various other cancers, such a method suffers from several crucial limitations.
Since there is large difference between the position and shape of the breast during mammography and surgery, images taken during mammography are unusable for stereotactic positioning during the surgical procedure, thus greatly complicating and prolonging the tumor removal procedure and leading to undue discomfort to the patient.
In addition, serious limitations of the above mentioned procedure result from the implantation of a long wire often present in the breast for many hours at a time while the patient awaits surgery. The surgeon must follow this wire into the breast to the located tumor, although ideally, the entry pathway into the breast should be designed independently of the wire, since this implanted wire may not always represent the optimal entrance trajectory. In addition, the presence of wire(s) extending outside the breast greatly increases the risk of infection. Another example of a medical procedure which benefits from tissue region localization is minimally invasive surgery. Although minimally invasive surgery is currently limited in the applications thereof, it presents numerous benefits over conventional surgery. In comparison to conventional surgical methods, minimally invasive surgery reduces the time and trauma of surgery, postoperative pain and recovery time, making the surgical procedure safer and less discomforting to the patient. Examples of medical instruments developed for minimally invasive surgery include laparoscopic, thoracoscopic, endoluminal, perivisceral endoscopic, and intra-articular joint instruments.
Minimally invasive surgery can also use a variety of radiation sources such as lasers, microwaves, and various types of ionizing radiation, to effect tissue manipulation. In addition, cryosurgery has also been used in a minimally invasive manner to treat carcinoma of the prostate, breast, colon and other organs.
A major hurdle facing the surgeon or radiologist in using minimally invasive surgical instruments has been the difficulty in visualizing and positioning such instruments. Decreasing instrument size and increasing complexity of operations have placed greater demands on the surgeon to accurately identify the position of the instruments and the details of the surrounding tissue. Visualization is a critical component to the successful use of minimally invasive surgical or diagnostic instruments.
In laparoscopic surgery, for example, visualization is accomplished by using fiber optics. A bundle of microfilament plastic fibers is incorporated in the instrument and displays a visible image of the field of interest to the surgeon. The quality of this image directly impacts the surgeons ability to successfully manipulate tissue within the patient's body.
Still another area which can benefit from intrabody localization and positioning of tissue regions is robotic assisted surgery. Recent advances in medical imaging technology, such as, for example, magnetic resonance imaging (MRI), especially open-MRI, and computer tomography (CT), coupled with advances in computer-based image processing and modeling capabilities have given physicians the ability to visualize anatomical structures in patient's, in real time, and to use this information in diagnosis and treatment planning.
The precision of image-based pre-surgical planning often greatly exceeds the precision of actual surgical execution. Precise surgical execution has been limited to procedures, such as brain biopsies, in which a suitable stereotactic positioning frame is available. The restricted applicability of such a frame or device has led many researchers to explore the use of robotic devices to augment a surgeon's ability to perform geometrically precise tasks planned from computed tomography (CT) or other available image data. Machines are very precise and untiring and can be equipped with any number of sensory feedback devices. Numerically controlled robots can move a surgical instrument through a defined trajectory with precisely controlled forces. On the other hand, a surgeon is very dexterous, and is highly trained to exploit a variety of tactile and visual information. Although combining the skills of a surgeon with a robotic device can substantially increase the effectiveness and precision of various surgical procedures, such a robotic surgical device must have a precisely defined frame of reference, such as body coordinates, without which it cannot operate with precision.
Yet another type of medical procedure which can greatly benefit from intrabody localization and positioning of tissue regions involves non invasive radiation treatment of tumors, thrombi, vascular occlusions, enlarged prostate, and other physiological disorders.
Examples of such procedures include, but are not limited to, the irradiation of cancerous or benign tumors by a high intensity radioactive source or particle accelerator, the “gamma knife”, which employs a highly focused gamma ray radiation obtained from crossing or collimating several gamma radiation beams, the ablation of the prostate by microwave heating, the necrosis of diseased cells following ultrasonic radiation treatment, and local ultrasonically induced drug activation. With all of these applications it is critical that the focus of the energy be precisely directed to the area to be treated, otherwise unwanted damage is inflicted upon the healthy surrounding tissue.
To enable the precise localization of the instruments or radiation beams of the above mentioned procedures, stereotactic positioning is typically employed. This method maps the outer surface of a body, or any part, which is held immobile. Positioning can also employ sensors such as, for example, magnetic sensors (see, for example, U.S. Pat. No. 5,558,091) or acoustic transducers, which are positionably fixed to the skin. In yet another approach, light emitting beacons positioned on the skin, and whose position is measured externally by an appropriate imaging
Doron Eyal
Penner Avi
Porat Yariv
Edward, Jr. Timothy
Horabik Michael
Remon Medical Technologies Ltd.
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