Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-09-20
2003-04-08
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C606S021000
Reexamination Certificate
active
06544176
ABSTRACT:
FIELD OF THE INVENTIONS
The inventions described herein relate to the field of cryosurgery and ablative surgery.
BACKGROUND OF THE INVENTIONS
The system and methods described below enhance the accuracy and effectiveness of cryosurgery of the prostate and other treatment areas of a human patient. Cryosurgery of prostate is an effective treatment for prostate cancer and benign prostate hyperplasia, conditions which affect many men.
The use of cryosurgical probes for cryoablation of prostate is described in Onik, Ultrasound-Guided Crvosurgery, Scientific American at 62 (January 1996) and Onik, Cohen, et al., Transrectal Ultrasound-Guided Percutaneous Radial Cryosurgical Ablation Of The Prostate, 72 Cancer 1291 (1993). In this procedure, generally referred to as cryoablation of the prostate, several cryosurgical probes are inserted through the skin in the perineal area (between the scrotum and the anus) which provides the easiest access to the prostate. The probes are pushed into the prostate gland through previously placed cannulas. Placement of the probes within the prostate gland is visualized with an ultrasound imaging probe placed in the rectum. The probes are quickly cooled to temperatures typically below −120 C. The prostate tissue is killed by the freezing, and any tumor or cancer within the prostate is also killed. The body will absorb some of the dead tissue over a period of several weeks. Other necrosed tissue may slough off through the urethra. The urethra, bladder neck sphincter and external sphincter are protected from freezing by a warming catheter placed in the urethra and continuously flushed with warm saline to keep the urethra from freezing.
To maximize the effectiveness of-the procedure, the entire prostate should be ablated. At the same time, surrounding structures such as the rectum and the neurovascular bundles should not be frozen. The amount of the prostate which is ablated by the cryosurgical procedure depends on the number of cryoprobes used and their placement within the prostate gland. Wong, et al., Cryosurgery as a Treatment for Prostate Carcinoma, 79 Cancer 963 (March 1997), suggests a placement scheme for cryosurgical probes within the prostate. Probes were inserted through the perineal area into the prostate while attempting to keep the probes within 1.8 cm of each other. The systems and methods presented below were developed to assist surgeons in placing the probes as suggested by Wong, or as suggested by others, with the assistance of ultrasound imaging and computer graphics and computer assisted calculations of optimal probe placement within the prostate.
SUMMARY
The present invention is a system for placing cryoprobes in a treatment area of a human patient. The system includes a computer system for displaying an image of a treatment area, a template of suggested cryoprobe placements in the treatment area and images of actual cryoprobes placed within the treatment area. The computer system is programmed to perform the steps of: acquiring the image of the treatment area, determining desired dimensions of the treatment area based on the image of the treatment area, determining the optimal cryoprobe placements in the treatment area based on the determined desired dimensions to provide the template of suggested cryoprobe placements, acquiring the images of actual cryoprobes placed within the treatment area, and overlaying the template of suggested cryoprobe placements on the acquired images of actual cryoprobes. The resulting overlaying is provided on a display of the computer system, thereby allowing the surgeon to compare the actual cryoprobe placements with the optimal cryoprobe placements as determined by the computer system.
Also described are algorithms and a corresponding computer program designed to calculate the optimal position of the cryoprobes for effective cryosurgical ablation of the prostate in a wide range of patients. The algorithms decide whether the prostate size fits within parameters for successful calculations, whether five or sixth probes are required, the optimal placement of two cryoprobes in the anterior lobe of the prostate gland, the optimum placement for two cryoprobes in the outer portions of the posterior lobe of the prostate, and the optimum placement for one or two cryoprobes in the center area of the posterior lobe of the prostate.
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Onik, Ultrasound-Guided Cryosurgery, Scientific American at 62 (Jan. 1996).
Onik, Cohen, et al. Transrectal Ultrasound-Guided Percutaneous Radical Cryosurgical Ablation of the Prostate, 72 Cancer 1291 (1993).
Wong, et al. Cryosurgery as a Treatment for Prostate Carcinoma, 79 Cancer 963 (Mar. 1997).
Eum Jay
Mikus Paul W.
Wong Wilson S.
Endocare, Inc.
Ginsberg Lawrence N.
Imam Ali M.
Lateef Marvin M.
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