Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2000-10-30
2002-11-26
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C606S021000
Reexamination Certificate
active
06485422
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. Cryosurgery of the 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 the prostate is described in Onik,
Ultrasound
-
Guided Crvosurgerv, 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, computer graphics, and computer assisted calculations of optimal probe placement within the prostate.
SUMMARY
The inventions described below are designed to assist surgeons performing cryoablation of the prostate gland in a male human patient. The system includes an ultrasound imaging probe and associated image processing hardware and software and image display systems, a computer system which generates a user interface which accepts input from a surgeon as to the size and shape of the prostate gland imaged by the ultrasound imaging system, and calculates an optimal cryosurgical probe placement for the particular imaged prostate gland, and displays a template on the display screen indicating the optimal placement. The system also images the cryosurgical probes as they are inserted into the prostate gland, and presents the images of the cryosurgical probes on the display for comparison with the template and the optimal placement positions as calculated by the system. Using the system, the surgeon performing the procedure can be assured that the intended probe placement corresponds to optimal positions, and that the actual probe placement is accomplished according to the optimal placement.
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 six probes are required, the optimal placement for 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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patent: WO 98/23214 (1998-06-01), None
Eum Jay
Mikus Paul W.
Wong Wilson S.
Endocare, Inc.
Imam Ali M.
Lateef Marvin M.
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