International Institute of Cryosurgery

Modern Hi -Tech CryoTechnology in 21st Century

Introduction

Looking at the development of the disease statistics of the past decades the enhancing rate of cancer disease and cancer deaths attracts attention, despite the exorbitantly increased financial expenditure for diagnosis and therapy (Big appliances, intensive medicine, etc.). In the last years no significant improvements could be achieved in this area, whereby the applied therapeutical methods are of limited efficiency. Among the other cancer kinds particularly breast cancer is advancing. Secondary manifestations like metastases and local recurrences due to protracting cancer cells as a result of diagnostic interventions mean a death sentence for patients with mamma carcinoma.

A new way of thinking must, thus, prevail in the future of cancer research and treatment. New disguise and treatment methods should enhance the healing rate of the cancer disease. Modern cryosurgery - a particularly gentle operation technique - experiences nowadays an international attention and dissemination. Good results can be proven through long-standing practical experience and numerous international publications. Thereby it has been shown that a successful employment of this method can only be reached through the development of effective medical-technical appliances. The existing new concept of a multimodal oncology demonstrates how modern, cryosurgical technology for diagnosis, prevention and treatment of cancer could be developed and produced.

What is Cryosurgery?

Cryo-, freeze- or cold-surgery is the operative cutting of tissue or the targeted destruction of pathological tissue by induced cold necroses at temperatures down to –196°C. Tumors are usually not excised but shock-frozen. In these cases vacuum-isolated cryoinstruments (cryoprobes, cryoscalpels, cryoclamps, cryoneedles) are used. These instruments are cooled to -170°C to -190°C by the evaporation of liquid nitrogen.

In the last 32 years, Univ.-Prof. Nikolai N. Korpan, MD, PhD, Professor of Surgery, and his colleagues together in co-operation with other international scientific institutions have developed and refined new cryosurgical techniques for operative procedures in patients with liver and pancreas tumors, breast cancer, lymph node metastases, and recurrent skin cancer.

Cryosurgery is established in medical practice both as a single technique as well as supplementary to other oncological treatments. The development of the cryocautery (on the Cooper principle), which makes the destruction of large areas of tissue by extreme hypothermia possible, was the technical prerequisite for a cryosurgical method applicable in general surgery. However, the reliable destruction of tumors requires the use of high-performance devices.

Main Mechanisms of Cryosurgical Action

Numerous theoretical and experimental studies in vitro and in vivo have been carried out to understand the action of low temperatures on tissue. It has been determined that the processes of ice crystallization are here of primary importance. Current opinion holds that one of the most important elements contributing to the action of subzero cold is intracellular ice formation, which damages the delicate cell structures.  Also important in cryoactivity is the formation of extracellular ice, which is followed by cell and tissue dehydration as well as protein denaturation and rupture of the cell membranes. But the major effect on cell damage and cell destruction in cryoactivity is exerted by the speed of freezing and of thawing of the tissue.

The macroscopic picture resulting from the influence of cold on different organs is almost always identical. At first one notices a mild hyperemia. This is followed by a hint of a change in color of the tissue to livid, after which a snow-white area of solid ice builds around the cryoprobe, which expands as the temperature sinks and the effect of the action of cold increases. Then the ice formation decelerates and finally ceases at –196°C. After thawing, the tissue has regained its original color and consistency. In the hours immediately following the area of focus swells up with edema, and after 3-4 days a completely necrosed focus with a discolored gray surface has formed.

 Several days later the process of regeneration begins with the sloughing off of the necrotic tissue. After about 4 weeks the deep necrotic crater is entirely replaced by course granulation tissue.

Microscopically the picture is similar. Total cell dissociation with interstitial bleeding can be seen – a hemorrhagic infarction immediately followed by the formation of an unstructured, homogeneous mass, i.e., a coagulation necrosis. With the sloughing off of the necrotic mass, a seam of fibroblasts appears in the border foci that initiates regeneration absent of leucocytic infiltration (aseptic necroses). Finally, a hypocellular stoma rich in connective tissue fibers forms.

Under the electron microscope, swelling of the mitochondria, fragmentation of the plasma membranes, and thickening of the nuclei can be seen.

 Our own experimental studies in the animal model on dog livers and pancreas showed that the CryoDevitalization zone of the liver parenchyma had a sharp, well defined line of demarcation clearly discernible contours. On the 5th postoperative day the liver parenchyma that had been frozen was now a pronounced necrosis of homogeneous substance. In the following weeks, granulation tissue formed. Four weeks later loose connective tissue with numerous blood vessels formed in the cryozone, after 9-10 weeks there was tight connective tissue and after 12 weeks the transformation of the cryozone of the liver parenchyma to connective tissue was complete.

Already in the works of Hippocrat, Galen, Celsus and Ibn Sina numerous indications to the treatment of various diseases through warmth deduction can be found, as in cases of haemostasis, analgesia and at feverish states and inflammations. The modern cryosurgery leans on the theoretical, clinical and experimental experiences since 1963. However, because of lacking technical-apparative prerequisites no dissemination could take place. A successful use of this method - particularly for various cancer types - is only possible through the development of efficient medical-technical appliances.

The key points of the modern cryosurgery concept are:

The most important application fields are as follows:

Contraindications: are not known at this point in time.

Advantages:

  1. The most important advantage of cryosurgery is impediment respectively prevention of local cancer recurrence as well regional and distant metastatic spread of malignant tumor cells during tumor removal - since no "cutting" takes place.
  2. Short trauma after both operation and narcosis.
  3. Through direct entrance opportunity a short or no narcosis at all is possible. On many applications narcosis can be dispensed with since the cold already has an analgetic effect.
  4. The convalescence reduces itself to a fraction of the usual stationary staying periods.
  5. Good cosmetic result: no scar formation. When cryosurgery is applied on the skin surface (on the outside) scars are avoided (e.g: tumors in the face).
  6. The resorption of this kind of frozen tissue seems to additionally carry a vaccination effect with it - however, this effect can scientifically not be explained yet.
  7. No local complications deriving from the operating table.
  8. Quick and technically simple tumor removal process.
  9. Good removal of both benign and malign tumors.
  10. Substantial subjective facilitation with cancer patients through cryosurgical palliative procedures with a pain reduction (painlessness or pain reduction) and fetor ex ore as well as improvement of the general condition through getting the tumor growth under control.

The modern day of cryosurgery of the present consists of achieving efficiency and effective modality through good, uncomplicated surgical results and a high curative rate (treatment rate) as well as high life quality of the operated patients.

In order to reliably destroy the pathological tissue, especially malign tumours, thus achieve a successful cancer treatment high quality appliances need to be implemented. The new universal "Cryosurgical System" is universally applicable in the modern cryosurgery, especially suitable for particularly mild cryosurgical operation techniques in the medical application area. The cryosurgical system created by “International Institute for Cryosurgery” in Vienna, Austria is world-wide the leading appliance in the medical field. Finally, the modern cryosurgical unit ,,FreezeForce1" is a highly sophisticated Universal Cryosurgical System developed to meet the most demanding needs of today's „White Surgery".

On the basis of own long-standing theoretical, experimental and clinical research, experience and knowledge in the field of modern cryosurgery a new generation of highly efficient appliances under the market name "FreezeForce1" is intended to be developed, thus enabling cryosurgery to an international breakthrough.

The Latest Developments in Cryosurgery

The development of unique state-of-the-art high-performance medico-technical cryoinstruments and devices (see Table):

The worldwide demand for modern cryosurgery equipment is currently estimated from 10000 to 12.000 units globally.

Technical Data of the own developed and patented device

"FreezeForce1"
(in comparison with the most famous cryosurgical devices)

Characteristics

"FreezeForce1"

"CRYO-6",
Germany

"Endocare", USA

"CS-5"
Candela (USA)

Cryoexposure temperature range, °C

from minus 1 till
minus 190 °C!!!
(in contact with bio tissue which is frozen)

NA (≈ -100°C)

minus 100 (without thermal load)

NA (≈ -80°C)

Applied cryoagent

liquid nitrogen

liquid nitrogen

gaseous argon

liquid nitrogen

Freezing zone volume

1-300 cm3

Diameter 10 mm

Diameter 10 mm

Diameter 5 mm

Time of emergency heating, minutes

1.1

NA

NA

NA

Accuracy of temperature stabilization under cryoexposure, oC

± 1

No stabilization

No stabilization

No stabilization

Time needed to be ready for use, minutes

1,0-2,2

2-3

1

NA

Time of continuous operation under condition of one filling of cryostat, minutes

90 (cryoagent volume 6l)

30 (cryoagent volume 48 l)

NA

NA (cryoagent volume 90 l)

Working pressure, ATM

2.4

15

50

NA

Consumed power, W

400

NA

700

NA

Size, mm

250x275x700

550x550x1300

483x635x1245

600x900x1760

Weight, kg

31

90

52,6

106

Fields of application
  • UNIVERSAL!!!
  • Sets!!!
  • Practically all medical fields with appropriate applicators usage!!!

only urology,
liver tumor
No sets

only urology,
liver tumor
No sets

only urology,
liver tumor
No sets

Keys to success

The keys to success in this business are:

Product

Our patented cryosurgical system FreezeForce-1 consists of a compact, easY:to-operate console and associated accessories that inck.Jde a set of cryo-applicators of special design to deliver ultra -bw temperatures to the therapeutic tissue with hgh precisbn and automatic control over freezilg and lhawilg cycles. Cryo -probes monitor temperatures in the surroundilg tissue. FreezeForce-1 features space and time precisbn targeting capabilities together with large freezing volumes to ensure complete destructbn of cancer cells with mininal harm to healthy tissue. The CryoSurgical Systems are intended for use i1 open, milimally invasive procedures in general surgery, urobgy, gynecobgy, oncobgy, neurobgy, dermatobgy, ENT, proctobgy, pulmonary surgery and thoracic surgery.