Cryoablation and Cryobiology
      
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Prostate: Cryotherapy

Cryoablation

“The in situ freezing and devitalization of tissues, which can be applied and controlled precisely to produce a predictable zone of necrosis that will destroy the target lesion as well as an appropriate margin of surrounding tissue”

(Patel BC, et al. J Surg Oncology. 1996;63:256-264)

Cryobiology

As temperatures approach the hypothermic range, extracellular water begins to crystallize and a hyperosmotic extracellular environment that draws water out of the cells is created. As the process continues, extracellular ice crystals grow, cells shrink, and membranes and cell constituents are severely damaged. Within a short time (minutes), the increased electrolyte concentration is sufficient to destroy the cells. This effect of cell dehydration and solution concentration, called solution-effect injury (Figure 1), is not always lethal to cells; intracellular ice formation (Figure 2) is a more significant threat to cell viability and is almost always lethal (Mazur, 1963, 1968, 1977, 1981; Maryman, 1966; Pegg, 1987; Sherman, 1962). Solution-effect injury is associated with low freezing rates, while intracellular ice formation is commonly associated with fast freezing rates. Although pure water begins to freeze at 0°C, extracellular ice formation is initiated at approximately –7 to -10°C, and by -15°C intracellular ice begins to form (heterogeneous nucleation). By -40°C all metabolic processes are expected to have ceased (homogenous nucleation) (Baust and Change, 1995). Either an extremely low freezing rate (on the order of several degrees Centigrade per minute) or a very rapid freezing rate (on the order of hundreds of degrees Centigrade per minute) is considered to have the most destructive effect on biological tissue.

Figure 1: Solution-effect injury

Normal Tissue
Normal Tissue

Extracellular Ice Formation
Extracellular ice formation

Hyperosmosis & Dehydration
Hyperosmosis & Dehydration

Figure 2: Intracellular ice formation

Normal Tissue
Normal Tissue
Intracellular ice formation
Intracellular ice formation
Intracellular ice crystals
Intracellular ice crystals

Applying cold energy to human tissues is a well-known technique for treating various lesions as an alternative to surgery. Since the 19th Century, many trials have been conducted to prove its efficiency in tissue ablation. In the early 1960’s cryosurgery was revived with two types of equipment that utilized liquid nitrogen as the cryogen. The first generation devices used a funnel through which liquid nitrogen was poured. Large diameter probes subsequently replaced them. Due to difficulties in controlling the size of the iceball and its freezing-thawing characteristics, this equipment was suitable only for clinical applications that did not require a high degree of accuracy. It was abandoned due to the high rate of significant complications and adverse effects.

In the late 1990’s the SeedNet™ Cryotherapy System was introduced, a new generation cryotherapy system based on an advanced gas expansion method (Joule-Thomson principle). This method demonstrates significant improvement in controlling the freezing process, and through use of ultra-thin CryoNeedles™ ensures that the target tissue is thoroughly frozen without gaps in the frozen region (high resolution coverage).


SeedNet™ Cryotherapy System

Oncura's SeedNet system is a minimally invasive treatment for prostate and renal cancer. Easy to learn and simple to use, SeedNet provides optimum accuracy, efficiency and control in the cryoablation process.

The SeedNet system employs ultra-thin 17-gauge CryoNeedles as opposed to outdated 3 mm cryoprobes. These slender needles are specifically designed for direct percutaneous insertion, eliminating the use of an insertion kit, and can be added, removed or repositioned within seconds causing minimal trauma. CryoNeedles needles generate precision iceballs that combine to create a frozen region with uniform lethal temperatures.

The SeedNet system is specifically designed for use by urologists and presents an innovative alternative to prostatectomy and radiation treatments. Based on the brachytherapy setup familiar to many urologists, this procedure is easy to learn and simple to use. Ultra-thin CryoNeedles guided through a template are percutaneously inserted into the prostate and generate cancer-killing iceballs that destroy prostatic tissue.

CryoNeedle placement and positioning, iceball formation and the freezing process are clearly viewed in real-time using advanced imaging modalities.

Technology & Innovation

CryoNeedle

  • Patented 17-gauge (1.47mm) needle technology produces precise and accurate ice balls
  • Needle shaft has 5mm and 5cm markings indicating distance from the tip
  • Thin grip optimizes handling and maneuverability during needle insertion
  • Sharp tip allows direct percutaneous insertion
  • Unique needle insertion techniques using a template
  • For ablation of prostate and renal cancer
  • Auto target temperature set-up

IceRod

  • Incorporates all of the 17-gauge CryoNeedle technology plus...
  • An advanced heat exchanger which produces a precise ice ball that is comparable in size to larger diameter cryoprobes
  • Improved sterile field access with longer flexible tubing (8 foot)
  • Color coded handle indicates the 17-gauge needle selected
  • Reduces the number of kidney punctures per treatment - reduction of total EBL
  • Auto target temperature set-up

Put the freeze on prostate cancer

SeedNet cryotherapy is a proven method for treating prostate cancer from locally confined to locally advanced disease stages. Results demonstrate excellent local control of the disease based on PSA levels of less than 0.4 ng/ml and the rate of major complications compares favorably with other modalities. SeedNet is also routinely and successfully used on patients with high PSA and Gleason scores.

What is SeedNet?

SeedNet is the new generation in cryotherapy for prostate cancer. Ultra-thin needles, exclusive to the SeedNet system, produce iceballs of extreme sub-zero temperatures that thoroughly destroy the prostate including all cancerous tissue while sparing critical structures such as the urethra. Easy to use argon gas provides controllable freezing capability and replaces old technology liquid nitrogen. SeedNet combines the good curative rates of cryotherapy with an accurate and easy to perform technique that can be completed in under two hours.

Easy to learn and simple to use

The procedure incorporates the brachytherapy set-up, familiar to many urologists and radiation oncologists, including an insertion template mounted on a stepping device. Tedious free-hand probe placement is eliminated and needles are easily and precisely guided to target location within the prostate using an image on the ultrasound that corresponds to the template grid. The iceball formation is monitored in real-time for controlled ablation of the prostate while avoiding damage to collateral tissue. Temperature sensors monitor local temperature in and around the prostate for an added measure of safety.

Salvage cryotherapy for recurrent prostate cancer

SeedNet provides a solution for recurrent and residual prostate cancer following radiotherapy. Given the limited therapeutic options for treating secondary prostate cancer, SeedNet offers a reasonable solution for eradicating recurrent prostate cancer.

How does SeedNet work?

An insertion template like that used in radioactive seed implantation (brachytherapy) is placed against the perineum. Ultra-thin CryoNeedles are easily guided via the template and inserted through the perineum into the prostate. Argon gas circulating through these needles generates very low temperatures causing the formation of ice. Many precision iceballs combine to create a frozen region that conforms to the size and shape of the prostate. The freezing process is lethal to all cells and thoroughly ablates all prostatic tissue.

As with brachytherapy, the CryoNeedles are easily inserted and guided to their target locations using an ultrasound probe placed in the rectum. Moreover, the entire SeedNet procedure, including the freezing and thawing processes, is carefully monitored in real-time with ultrasound imaging. A catheter, through which warm water is circulated, is inserted in the penis in order to protect the urethra against damage from cold. The doctor plans where to place the needles prior to the procedure so that the entire prostate will be completely treated. However, at any time during the procedure the doctor is able to change the placement of the needles or add and remove needles making this an extremely flexible and user-friendly system. Either spinal or general anesthesia is used during the procedure.

Similar to radical prostatectomy and radiation therapy, SeedNet treats the entire prostate for cancer and not only a specific area that may contain a tumor. In order to ensure the destruction of all cancer cells, the goal is to freeze tissue beyond the membrane that encloses the prostate. In doing so, nerve bundles associated with erection may be affected. Potency may return over a period of time and you should discuss with your doctor the various treatments for alleviating this condition.

Who is a candidate for SeedNet treatment?

SeedNet is a treatment option for the many prostate cancer patients who are seeking minimally invasive treatment instead of surgery, or who prefer not to have radiation treatment. The procedure can be used for a wide range of disease stages from locally confined prostate cancer to locally advanced disease and radiation failures.

SeedNet is routinely and successfully used on patients with high PSA and high Gleason scores. Generally men with smaller prostates are better candidates for SeedNet treatment. Those with larger prostates can undergo hormone therapy to decrease prostate size prior to SeedNet treatment.

Benefits of SeedNet cryotherapy

  • Viable and effective treatment option: many patients are unwilling or unable to undergo surgery or radiation treatment
  • Minimally invasive: uses ultra-thin 17 gauge CryoNeedles no larger than biopsy needles
  • Easy to perform procedure: usually completed in under two hours
  • Brief overnight hospital stay, unlike surgery that requires several days' hospitalization
  • Quick recovery time: mobility the same day of the procedure and return to routine activities within a few days
  • Can be performed under local anesthesia: easier and faster recovery time as opposed to surgery
  • Repeatable in case of cancer recurrence: SeedNet is a reasonable solution for eradicating cancer that has returned following treatments of surgery, radiation therapy or cryotherapy
  • Minimal pain and discomfort: causes only minimal bruising and swelling as opposed to major trauma with surgery

 

 


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