Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-05-04
2001-10-30
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S007000, C600S439000, C600S427000
Reexamination Certificate
active
06311084
ABSTRACT:
BACKGROUND OF THE INVENTION
Patients with prostate cancer currently have access to a treatment alternative called prostate brachytherapy. This treatment alternative is performed as an outpatient procedure, has limited side effects and minimal interruption to daily living. Prostate brachytherapy combines transrectal ultrasound with radioactive seed implantation. Tiny radioactive seeds are permanently implanted directly into the middle of the cancer within the prostate gland during the prostate brachytherapy. The procedure is usually completed within 60-90 minutes. The cure rate of prostate brachytherapy compares favorably to surgery and external beam radiation therapy. More importantly, the side effects of brachytherapy seem to be more acceptable in that there is a very low risk of developing incontinence, impotence and rectal damage.
Using transrectal ultrasound, the prostate implant team determines the exact size of the prostate gland, the extent of the cancer and the amount of radioactivity required. This information determines the number of seeds needed and where they should be placed.
Typically, the patient arrives at the hospital two hours before the scheduled time of the procedure. The anesthesiologist determines the best type of anesthesia for the patient; generally a spinal anesthetic is administered so that the patient will have no feeling from the waist down.
After the anesthetic is administered, the prostate gland is located with transrectal ultrasound through a probe device shown in FIG.
1
. The radioactive seeds are then placed within the prostate gland in a sequential fashion using needles inserted just behind the scrotum. Historically the needles are placed by hand, with template guidance. Ultrasound imaging, provides geometric feedback about the location of the needles, but does not provide the level of soft-tissue visualization of other imaging techniques. Dosimetric feedback is only available post-procedure, there is no option to adjust the implant dosage during the procedure based on dosimetric feedback. Thus, improvements in prostate brachytherapy are desired.
SUMMARY OF THE INVENTION
Prior art systems lack real-time dosimetric feedback and usually require post procedure dosimetry. Additionally, ultrasound imaging does not provide the excellent soft tissue visualization and 3-dimensional data acquisition of Interventional Magnetic Resonance imaging. Coupling the planning phase with the treatment phase in one session as in the present invention has the advantages of allowing the procedure to occur in a single day. This eliminates the prior art problem of re-aligning the patient to the exact position they were in for the planning phase when the treatment phase commences. Modification of the treatment plan is now possible during the procedure.
The present invention solves the disadvantages of the prior art and provides a radiation seed implant planning system. In another aspect, the present invention provides an improvement over the methods and devices used in prior art prostate brachytherapy. In particular, the present invention includes an imaging system device, a plurality of needles for expelling radioactive seeds, a needle template and a treatment planning and procedure module. The needle template contains working holes for the needles, calibration points for template registration and a guide hole for an orientation device. The treatment planning and procedure module includes: (i) a template registration process that uses the calibration points to map needle template coordinates into imaging system coordinates, (ii) a target definition module for selecting target and sensitive areas based upon images generated by the imaging system, and (iii) an implant planning module for creating a treatment plan incorporating real-time dosimetry.
The present invention provides image guided brachytherapy to target tissue areas by imaging (in real-time) the target tissue using an imaging system. A needle template is placed in proximity to the target tissue and the needle template location is mapped to the coordinate system of the imaging system. A user of the invention then defines the bounds of the tissue targeted for treatment on the planning system. The planner, using the planning system, creates a treatment plan for insertion of needles. According to the created treatment plan, each needle holds a predetermined number and spacing of radiation seeds and is inserted through working holes in the needle template. The seeds are placed and effect (dose) of the seeds is calculated. Radiographic, geometric and dosimetric feedback is acquired on the placement of the needle and the treatment plan may be modified based upon the acquired feedback. If the needle placement is acceptable a plurality of radioactive seeds are placed in the tissue from the needle. The procedure continues until all necessary needles are placed, and final coverage of treatment is evaluated using real-time images from the imaging system.
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Cormack Robert A.
D'Amico Anthony V.
Kooy Hanne M.
Tempany Clare M.
Hamilton Brook Smith & Reynolds P.C.
Lateef Marvin M.
Shaw Shawna J
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