Surgery – Instruments – Stereotaxic device
Reexamination Certificate
1998-11-04
2001-04-10
Kamm, William E. (Department: 3762)
Surgery
Instruments
Stereotaxic device
C600S429000
Reexamination Certificate
active
06214018
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to a method and apparatus for the removal of tissue from a region of interest in a body part of a patient. More particularly, the present invention relates to a method and apparatus for the removal of tissue from a region of interest in a body part of a patient, such as a breast, wherein the tissue removal is guided by stereotactic radiography.
2. Description of the Prior Art
Stereotactic mammographic devices have been used to determine the three dimensional coordinates of a region of interest in a breast relative to a point of reference on the stereotactic devices. The three dimensional coordinates are generally used for diagnostic and surgical procedures, and more particularly to insert the end of a wire, the tip of a biopsy needle or the tip of a rotary cutting tool into the region of interest in the breast. Wires are generally used to guide a surgeon to the region of interest to remove part or all thereof. The biopsy needle is typically used to sample cells or tissue from the region of interest. The rotary cutting tool is generally used for the removal of tissue from the region of interest.
One example of a stereotactic mammographic device is described in U.S. Pat. No. 5,289,520, which is incorporated by reference in its entirety. The commercial embodiment of the device described and illustrated in the patent has been used to guide a biopsy needle into a region of interest to obtain samples of cells and tissue. Also, such device has been used to guide rotary surgical cutting instruments to remove tissue from a region of interest.
As described in C. W. Putnam, “Techniques of Ultrasonic Dissection in Resection of the Liver”,
Surgery, Gynecology
&
Obstetrics
, Vol. 157, pgs. 474-478, November, 1983, ultrasonic aspirated dissectors, such as the Cavitron Ultrasonic Surgical Aspirator, comprise a handpiece which is connected to a control console. The handpiece contains a water-cooled magnetostrictive transducer that activates a hollow titanium tip along its longitudinal axis at a frequency of approximately 23,000 cycles per second. The tip of the handpiece is irrigated and a suction line is connected to the hollow tip to aspirate the irrigant, blood and tissue fragments. The instrument works by generating ultrasonic vibrations which selectively fracture tissue in proportion to its water content. The fractured tissue is removed via the suction line.
Typically such ultrasonic surgical aspirators are controlled by hand in an open surgical procedure which is not minimally invasive. However, as the above referenced article suggests, such devices are used because they afford greater differentiation between the various types of tissue structure found during a surgical procedure involving a liver, for example. Heretofore, it is not believed that an ultrasonic surgical aspirator has generally been used as a minimally invasive tool to remove tissue from a region of interest in a patient's body part, such as a breast, nor has such a tool been guided by a stereotactic radiographic device to remove tissue from the region of interest.
SUMMARY OF THE INVENTION
Accordingly, it is a principal object of the present invention to guide an ultrasonic surgical aspirating tissue removal tool to a region of interest inside a patient's body part.
It is another object of the present invention to guide and control a tissue removal tool within a volume surrounding a region of interest inside a patient's body part.
These objects are accomplished, at least in part, by providing a method and apparatus for removing tissue from a volume surrounding a region of interest within the body part of a patient. The apparatus comprises a body part holder adapted to hold the body part immobile. It also defines a predetermined point of reference relative to the immobile body part. The apparatus employs a stereotactic imaging assembly having an radiation transmission source adapted to receive operating instruction signals and to irradiate the body part, and a radiation receiver adapted to transmit image signals corresponding to radiation received from the transmission source passing through the body part to obtain stereotactic images of the held body part and the region of interest therein. The apparatus includes a display adapted to receive display signals and to display stereotactic images of the body part and region of interest therein corresponding to the display signals received. A user interface, adapted to interactively enable a user to place a boundary around the region of interest of the body part displayed, provides boundary signals representing the dimensions and location thereof around the region of interest. The apparatus also includes a motorized tissue removal tool guiding stage capable of moving relative to the predetermined point of reference. The removal tool guiding stage is adapted to receive drive signals to drive the stage to a position relative to the predetermined point of reference and is further adapted to provide position indicating signals to indicate the position of the stage relative to the predetermined point of reference. A tissue removal tool is held by the tool guiding stage. The tissue removal tool has a fragmenting tip and a means for extracting or removing fragmented tissue from the fragmenting tip. The apparatus is directed by a controller adapted to: provide operating signals to the radiation source to cause the radiation source to transmit radiation; receive image signals from the radiation receiver; provide display signals to the display based upon the image signals received; receive boundary signals from the user interface; provide boundary display signals to the display based upon the boundary signals received; calculate the size and location of a tissue removal volume relative to the predetermined point of reference based upon the boundary signals received; provide drive signals to the motorized guiding stage to command the stage to move to a position within the calculated tissue removal volume; and receive position indicating signals from the guiding stage.
The method of the present invention comprises several steps including: holding a body part of a patient having a region of interest therein relative to a predetermined point of reference; obtaining stereotactic images of the body part containing the region of interest therein; and displaying the stereotactic images. Once the stereotactic images are displayed, the method involves the following additional steps: placing a boundary around the region of interest in each displayed stereotactic image; determining the size and location of a tissue removal volume surrounding the region of interest relative to the predetermined point of reference from the location, dimensions and relative geometry of the boundaries; holding a tip of a tissue removal tool relative to the predetermined point of reference; and moving the tip of the tissue removal tool within the tissue removal volume to remove tissue from within the tissue removal volume.
Other objects and advantages of the present invention will become apparent to those skilled in the art from the following detailed description read in conjunction with the attached drawings and claims appended hereto.
REFERENCES:
patent: 5594769 (1997-01-01), Pellegrino et al.
patent: 5609152 (1997-03-01), Pellegrino et al.
patent: 5735264 (1998-04-01), Siczek et al.
patent: 5799055 (1998-08-01), Peshkin et al.
patent: 5830219 (1998-11-01), Bird et al.
patent: 9703609 (1997-02-01), None
patent: 9806334 (1998-02-01), None
patent: 9840026 (1998-09-01), None
Ultrasonic Mucosal Proctectomy Without Endorectal Pull-through by T. Heimann, R. Kurtz, S. Shen-Schwarz, A. Aufses, Jr., fromDiseases of the Colon and Rectum, May 1985, vol. 28, No. 5.
Techniques of Ultrasonic Dissection in Resection of the Liver by C. Putnam, reprint fromSurgery, Gynecology&Obstetrics, Nov. 1983, vol. 157, 474-78.
A Bloodless Technique for Tongue Surgery by J. Weitz, W. Hudgson, L. Loscalzo, A. McElhinney,Head&Neck Surger
DeFrietas Kenneth F.
Kreizman Alexander S.
Rego Alan W.
Kamm William E.
Trex Medical Corporation
Ware Fressola Van der Sluys & Adolphson LLP
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