Surgery – Radioactive substance applied to body for therapy – Radioactive substance placed within body
Reexamination Certificate
2001-07-19
2002-12-31
Winakur, Eric F. (Department: 3736)
Surgery
Radioactive substance applied to body for therapy
Radioactive substance placed within body
C604S116000
Reexamination Certificate
active
06500109
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable.
BACKGROUND OF THE INVENTION
This invention relates in general to prostate implanting devices, and more specifically to a disposable guide that can be used alone or in conjunction with other seed stabilization devices, for treatment of prostate cancer.
Prostate cancer is the most common malignancy of the male genitourinary tract. In 1998, the number of cases of prostate cancer in the United States, alone, was estimated to be 184,500, with approximately 39,200 men dying of the disease annually. (Landis, S. H., Murray T., Bolden, S., et al:
Cancer Statistics
1998.
CA Cancem J. Clin
48:6-29, 1998).
The various methods for treatment include surgical intervention, external radiotherapy, brachytherapy seed implants, high dose rate brachytherapy, cryotherapy (freezing) and RF (heat) therapy.
Surgical intervention and external radiotherapy are widely known. The latter treatment method involves two basic steps:
1. Guide interventional device(s) into the prostate gland under ultrasound guidance, either with or without a stabilizing device.
2. Kill tissue by delivering energy, or in the case of cryotherapy, by taking away energy.
Brachytherapy is defined as the use of permanent implants or radioactive materials at the site. Brachytherapy has been successfully used in the treatment of prostate cancer. This is especially true when performed with the aid of implant stabilization devices, such as the AccuSeed, designed and manufactured by Tayman Medical, Inc., located in Chesterfield, Mo. The Tayman Medical AccuSeed stabilization device cradles the ultrasound probe so that the prostate gland can be viewed in real-time while inserting interventional devices through bores in the template to facilitate therapy. The bores in the template simply guide needles, etc. through the perineum and into the prostate gland.
High Dose Rate Brachytherapy involves temporary insertion of radioactive wires. The term radiation refers to energy propagated through space to destroy tissue. Cryotherapy is defined as the use of a very low temperature instrument to freeze tissue. RF therapy is defined as the use of electric current to heat tissue via an instrument that is in contact with the tissue.
Disadvantages associated with surgical intervention include impotence and incontinence due to damage of tissues in close proximity to the prostate, such as seminal vesicles and essential nerve bundles. External radiation can also have deleterious effects on surrounding normal tissues (e.g., seminal vesicles, essential nerve bundles, bladder, rectum, and the urethra). With permanent brachytherapy seed implants there is a potential for radiation exposure to hospital staff and family members because the radioactive seeds leave the facility with the patient. High dose brachytherapy has the disadvantage that it also involves radioactivity, although no radioactive materials leave with the patient. Researchers in cryotherapy and RF therapy are challenged to accurately predict heat transfer in the very complex system comprised of the prostate and surrounding tissues.
Advantages of high dose rate brachytherapy include higher confidence in dose calculations because treatment planning is done using actual needle positions after needle placement. This technique can reduce exposure to surrounding tissues such as the bladder and rectum. The short treatment time adds to the patient's comfort, and no residual radioactive materials or tissue remain in the patient when the procedure is over. Some of the above advantages, as well as the procedures and techniques, are pointed out in Rodriguez, et al,
High Dose Rate Brachytherapy In Treatment Of Prostate Cancer
13(3) pp. 503-523, 1999,
HematologylOncology Clinics of North America.
Brachytherapy is defined as the use of permanent implants or radioactive materials at the site. Two forms of brachytherapy for the treatment of prostate cancer are seed implantation and high dose rate brachytherapy:
Seed Implantation is performed on an out-patient basis under spinal anesthesia. The transrectal ultrasound probe is re-positioned to accurately reproduce the conformational plan format. Disposable implant needles that have been preloaded with radioactive seeds and absorbable spacers are then introduced through the appropriate needle guide holes in a template as indicated in the plan. Each needle is guided through the perineum to its predetermined position within the prostate under direct ultrasound visualization of the needle position within the prostate. The specified number of seeds are then implanted by withdrawing the needle while holding the stylet against the stylet stop. The seeds are pushed out as the needle is withdrawn by the stationary stylet. The AccuSeed Stepper, from Endocare, Irving, Calif., is used to position and stabilize the ultrasound probe and the implant needles.
The high dose radiation procedure is performed in the operating room using a spinal or general anesthesia. The patient is positioned in lithotomy position. The AccuSeed stepper is setup, and a high dose radiation template is mounted to the base and set up adjacent to the perineal area of the patient. The TRUS is utilized for the identification of the prostate gland. With the use of TRUS and fluoroscopic guidance, the implant needles are carefully inserted through the skin surface to the prostate gland. X-rays verify needle position. The template is then sutured at all four corners to the perineum. The catheters remain in place as the AccuSeed stepper is taken down and away from the patient. X-rays are utilized to optimize a specific treatment plan. When the dose is finalized the HDR remote afterloader is programmed with your individual treatment. The patient is then taken to the radiation oncology department. The implant catheters are connected to an HDR machine, to enable a radiation source to deliver treatment. The number of HDR treatments depends on the individual's prescription.
Cryotherapy is defined as the application of extreme cold to destroy tissue.
The cryotherapy procedure is performed with a local or spinal anesthesia. The patient is placed in lithotomy position and prepped and draped. The AccuSeed is set up and the cryotherapy template is mounted on the stepper to assist in holding the TRUS and placement of the cryotherapy probes. The prostate gland is measured with TRUS and the plan is evaluated for placement of the cryotherapy probes. The guide wires and dilators are then inserted under ultrasound at planned locations. A urethral warmer and thermocouples are placed in delineated areas to measure and protect surrounding tissues. A first freeze is accomplished with liquified argon gas. This gas creates ice balls as the tip of the cryoprobes encompassing the entire prostate gland. Extreme cold temperatures destroy all the prostate tissue including cancerous cells. After a thawing period of about thirty minutes, a second freeze is done to ensure effective treatment has been accomplished.
The most prevalent use of the current invention will be in high dose rate brachytherapy due to the need for the template to remain attached to the patient for extended periods, and that the treatment methods inherently include safety, efficacy, and popularity of its usage due to elimination of the inconvenience that occurs in the standard type of treatments as explained above.
SUMMARY OF THE INVENTION
This invention principally relates to a prostate implanting device, and more specifically provides for the very accurate seeding of a prostate malignancy at the exact site of its determined location, through the usage of the treatment template of this invention.
The present invention is a disposable template (also called a guide or a grid) to be used either freehand or in conjunction with the AccuSeed™ Stepper and Stabilizer, currently available from Tayman Medical, Inc., of Chesterfield, Mo. Although designed for use with the AccuSeed stepper and stabilizer, the template could be modified for use with other stepper/stabilizers.
The temp
Cha Bibianna Ahrum
Prichard James Bryan
Tokita Ken
Denk Paul M.
Tayman Medical, Inc.
Veniaminov Nikita R
Winakur Eric F.
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