Digital Co-60 Radiotherapy System
----------------------------------------------Gyro Knife
GammaStar Medical Group Ltd. Address: 15F Multi-media Building, 757 West Guangzhong Rd., Zhabei District, Shanghai, P. R. China Website: www.gammastar.com E-mail: overseas@gammastar.com Tel: +86-21-51095758 Fax: +86-21-61404252
April 16, 2007
Table of Content COMPANY PROFILE······················································································································2 INTRODUCTION OF GYRO KNIFE ·····························································································4 BRIEF INTRODUCTION ········································································································4 TECHNICAL SPECIFICATIONS····································································································6 CLINIC APPLICATIONS ··············································································································15 LIST OF CONTRACTED HOSPITALS ························································································16
1
COMPANY PROFILE GammaStar Medical Group Ltd., a high-tech company with its own proprietary intellectual property rights and profound expertise, is focusing on the R&D, manufacture and service of large-scale medical equipment. Technology, Service and Health are the purpose of company’s persistent development and struggle. Company’s long term objectives are to become a global medical group and build up top brand of global tumor radiotherapy chain center.
GammaStar has first-class specialists in the fields of nuclear physics, medicine, machinery, electronics, software, etc. Our core team had created and impelled the Gamma – Ray stereotactic radiotherapy industry in China with the compressed over ten-year industrial experience and the management team has affluent experiences, innovative spirits, complementary advantages and strong capabilities in integrating various resources in the industry.
“Digital Co-60 Radiotherapy System” (known as Gyro Knife) is one of the most advanced precise radiotherapy devices, which is invented by GammaStar Medical Group Ltd.. Gyro Knife integrates the merits of a linear accelerator and the previous generations of gamma knife into a single unit. Shanghai GammaStar has all proprietary intellectual property rights about it. We have already applied and hold the relevant patent, holding the SFDA in China at 14th May, 2006.
According to statistic research, malignant tumor is the third leading cause of death in the world nowadays. In China, the malignant tumor is the second leading cause of death. According to the statistic research from Ministry of Health of the People’s Republic of China, there is almost 2 million people getting cancer every recent year. 1.4 million people died because of cancer. (Ministry of Health of the People’s Republic of China – Disease Control Department, Apr., 2004) Base on the statistic research, there are about
2
1,000 radiotherapy equipments in China. However, it is estimated that the actual demand would be 3,000 units within 5 years. It is a huge potential market. The development of gamma ray radiotherapy technology can not only release the pain for the patients, but also bring up this industry with significant potential revenue and meanwhile build up international academic authority for Chinese radiotherapy industry.
Mr. Shipeng Song, the chief scientist of GammaStar Medical Group Ltd., is the party member of China Zhi Gong Party and the visiting professor of Huazhong University of the Science & Technology and University of Shanghai for Science and Technology. Mr. Song began the research of stereotactic radiotherapy technology in 1992 and up to now he has obtained over 90 patents for his invention. In 1996, he successfully invented the rotating gamma knife and which is consequently developed as one of a few advanced Chinese high tech medical equipments in the world. Because of the rotating gamma knife, he obtained a lot of awards, such as national technology progress first class award, Shenzhen Technology Progress first class Award and the golden award of the third National Technology Communication Convention, etc. Furthermore, the rotating gamma knife was approved by FDA on May, 1997. Nowadays, the gamma knife is becoming an industry with billions revenue and it is going to have a drastic growth, which is the opportunity to us. At present, GammaStar’s primary product is “Digital Co-60 Radiotherapy System” (known as Gyro Knife) as a new generation of radiotherapy equipment. The technology of “Gyro Knife” is used to treat various benign and malignant tumors in the whole body, as well as for functional disorders such as Intractable Pain, Trigeminal Neuralgia, Focal Epilepsy, and Parkinson’s disease. Therefore, Mr. Shipeng Song is hailed as “Father of China’s gamma knife”.
GammaStar is an innovative and rigorous company seeking to provide the best radiotherapy solution and professional service for patients worldwide. Together we could make contribution to the development of cancer care industry not only in China but also throughout the world.
3
INTRODUCTION OF GYRO KNIFE BRIEF INTRODUCTION “Digital Co-60 Radiotherapy System” (known as Gyro Knife) is one of the precise radiotherapy devices, which is invented by GammaStar Medical Group Ltd.. Gyro Knife integrates the merits of a linear accelerator and the previous generations of gamma knife into a single unit. As a consequence of the merged advantages, Gyro Knife is able to significantly increase the Radiotherapy Gain Ratio as a functional radiotherapy center such that making an evolutional change in the field of cancer care.
l 1.
Competitive Advantages in Technology The Gyro Knife is able to flexibly irradiate in different angles since the principle of the Space Gyroscope has been used. As a result of this revolutionary change, the Gyro Knife can treat wider types of tumors through the body, e.g. Super-Accurate treatment for brain, large-field radiotherapy for body and IMRT (Intensity-Modulated Radiotherapy).
2.
The Triple Focusing System: Higher Focus-Skin Ratio; Higher treatment Accuracy; Smaller Penumbra;
The Triple Focusing System makes the Focus-Skin Ratio, which is the physical indicator (The dosage in target to the dosage on the skin), to achieve an unreachable high level, 550:1 as measured by Ø160mm ball-phantom. This specific figure tells us that the damage to the skin is fairly limited while the target tissue has been treatment with a certain level of dosage. The advantages of this are good protections for normal and sensitive tissues, and much more flexible treatment plans. Moreover, the penumbra remains extremely small because of the Triple Focusing System; especially the smallest is only 0.5mm. The distribution of the relative dosage (we called the Gyro Peak) has achieve the performance of Brag Peak (Photon Therapy System).
4
3.
Self-Shielding System: Triple Radiation Protection, which significantly limits the radiation exposure in the environment and reduces the decoration cost for the therapy room (i.e. the thickness of wall only needs 0.5m for the Gyro Knife; 0.8 – 1.0m for Gamma Knifes; and 1.5m for the Linear Accelerator).
4.
The duration and cost of changing the radiation source: for us is approximately 2 hours, and for others is about 1 – 2 weeks. The cost for us is approximately half of the others.
5.
Superior Efficiency: The Gyro Knife has much the automatic control system than the Gamma Knife and the Linear Accelerator, so that helps the medical person working more efficiently and effectively. The system can control the different collimators and the irradiation time, forming 3-D image at any time. The innovative Marbletherapy technology make the randomly movement of multi-isocenter become real, which solving the problem of dosage odds.
6.
TPS (Treatment Planning System): Simplifies the treatment procedure, easy to use.
7.
Varies Position Setting: traditional Head Frame and Mask, Optional: the infer-red positioning system. (Simplifies the treatment procedures and reduce the patients’ painfulness).
5
TECHNICAL SPECIFICATIONS 1.
Treatment Head
The treatment head of Gyro Knife has a cast-steel shell with tungsten shielding, and it is designed to hold the Cobalt-60 radiation source with 7’000 Ci totally. The treatments head is also used as a container for transportation. The treatment head consists of two parts: the shell and the source switch. Four different sized collimators are distributed round the source switch.
1.1
1.1.1
Movement Parameters
Angle
♦
Arc Angle between vertical axis and Photon beam: 25°
♦
Treatment Head’s Rotating angle with gantry around body: ±180°
1.1.2
Speed
♦
Treatment Head Self-Rotation Speed: 30r/min
♦
Rotating speed of Gantry: 1r/min
1.2
1.2.1
Photon Beam Characteristic
Radiation Source
Cobalt-60; Activity Rate > 280Ci/g; Half-life: 5.27yrs;
1.2.2
Dose on focal-spot
2.5 Gy/min through our unique Triple-Focusing.
6
1.2.3
Field Sizes and Dose Distribution
♦
ф5mm ±1mm
♦
ф15mm ±3mm
♦
ф25mm ±5mm
♦
ф45mm ±5mm
The Penumbra is between 0.5mm – 5mm The time of automation of collimators change: < 1 sec.
1.2.4
Isocenter Accuracy (Radiation & Mechanical)
Isocenter Accuracy: ± 1 mm
1.2.5
Safety & Protection
When the source switch is off, the Kerma Rate in air 5cm above the equipment surface is less or equal to 200μGy, and 1m is less or equal to 20μGy, according to the <GB9706.17 – 1999>.
2.
Mechanical System
The Mechanical System is made by the main device and the 3-D Treatment Couch, and the main device is designed according to the principle of Gyro Rotating Mechanism.
2.1 Gyro Structure The radiation source is installed in a shielded gyro structure, and the first focusing is achieved by gyration of the gyro structure. The gyro structure and the gantry will rotate simultaneously, thus the second focusing is achieved through different incidence angle. The third focusing is achieved by the revolution of the gantry.
As the consequence of Triple-Focusing, the path of the radiation through the normal tissue will continuously change so the dose to the normal tissues is distributed instantly
7
and widely, while the dose on the target tissues will be integrated to achieve the doctor’s requirement.
The angle and the speed of the gyro structure’s self-rotating and revolution are able to be selected, and this is suitable to the doctor’s different treatment plans.
2.2 Rotation Disc The Rotation Disc is shaped as gyro, the treatment head (radiation source) will rotate as stated above. Therefore, the Digital Co-60 Radiotherapy is known as GYRO KNIFE. 2.3 3-D Treatment Couch All motorized movement in vertical, lateral and longitudinal directions, Powered by 3 sets of Servomotors. The system adopts high-accurate transmission drive force to achieve maximum exactitude, so that the target volume can be placed onto the target. Movement parameters ♦
X –axis: (Width) ±200mm.
♦
Y –axis: (Height) ±150mm.
♦
Z –axis: (Length)
1200mm.
The discrepancy is contained within ±0.5mm. The speed of the vertical movement is 2000mm/min
3.
Positioning System
In order to irradiate the tumor tissues, the radiation dose must be accurately delivered to the target. Gyro Knife uses body positioning frame and vacuum bag to hold the patient firmly to the couch, and uses CT/MRI technology to identify the dimension axis in computerized locating system. The components of the the positioning system for the whole body include treatment couch and vacuum bag, and the components for head positioning include head frame, four cylinder, four rivets and two N-shaped bars.
8
4.
Electric Control System
4.1 Content ♦
Control panel
♦
Computerized control system
♦
Electrical control cabinet
♦
Driving equipment
♦
Power supply and cable
4.2 Control Console The control panel, CCS, ECC, colour monitoring system, and intercom are altogether interconnected through cables.
4.2.1
Content
♦
Switch button
♦
Indicator light
♦
Computerized control system
♦
Intercom system
♦
Colour monitor
4.2.2 Control function ♦
General power supply switch
♦
System power supply indicator light
♦
Radiation off indicator light
♦
Radiation on indicator light
♦
Malfunction alarm indicator light
♦
Emergency operate button
9
4.3
Computerized Control System
From computerized control system, the following information could be controlled and realized ♦
Information of opening and closing of the shielding door
♦
Gantry position (angle) information
♦
Self-rotating speed of treatment head
♦
Radiation On/Off information
♦
Position information of the treatment couch
♦
Alarm information
4.4 Electrical Control Cabinet Include programmable controller, driving device, transformer set, air switch contactor, connection arranging and AC/DC voltage switch device, etc. External environment condition of the electrical control cabinet ♦
Room temperature: during operation: 0~40℃
♦
Storage/during transportation: -20~60℃
♦
Relative humidity: ≤75%
♦
Tremor: ≤0.5G
4.5 Driving Device Include 3D treatment couch positioning driving servo, great gantry driving frequency conversion electromotor, source switch rotating frequency conversion electromotor, source switch control stepper motor and high-accuracy rotation encoder.
4.6 Power 4.6.1 Input power ♦
Voltage: Three phases 380VAC ± 10%
♦
Frequency: 50HZ ± 1HZ
♦
Rating current: 40A/phase
10
4.6.2 UPS ♦
Power: 3KVA
♦
Continues work time: ≧10Min
♦
Capacity: Ensure source switch to be reliably switched off; treatment couch returns to zero position
♦
Switch time: 0
4.7 Others 4.7.1 Equipment’s protecting earthing impedance ♦
Impedance between terminal and mental parts: no more then 0.1Ω
♦
Impedance between earthing foots’ mental parts: no more than 0.2Ω
4.7.2 Continous creepage under normal working temperature No more than 5 mA under normal condition; no more than 10 mA under single malfunctioning condition
5. Treatment System 5.1 Treatment Operation Procedures ♦
Preparation before treatment
♦
Patient positioning
♦
Clinical image diagnostic equipment (such as CT, MRI) scan
♦
Making treatment plan with TPS software
♦
Treatment in operation for the patient
♦
Treatment finished
5.2 Treatment Planning System (TPS) ♦
Contouring 3D image of treatment position of pathological changes and important organs including body surface profile according to the inputted CT/MRI image data with positioning mark point.
11
♦
Evaluate incidence directions, magnitude, weighted dosage and target position; constitute the treatment plan of optimizing partition between pathological changes and normal tissues especially important organs in terms of dosage distribution
♦
6.
Print out the treatment plan details and detailed data of treatment positioning.
Security System
6.1 Identification ♦
Starting up the control system requires keys exclusively. Keys should be kept by the person specially assigned for the task, such as radiotherapist or physicists.
♦
Logging on TPS requires fingerprint.
♦
TPS adopts multi passwords. The passwords are classified by different rights.
6.2 Alarm System ♦
Dosimeters in treatment room are connected to the alarm system. It can immediately give tonetic and photic alarms while the radiation dosage rate over the planned quantity.
♦
Indication Light indicating radiation status will be installed in the treatment room.
♦
Indication Light indicating radiation status will be installed outside the shielding door.
♦
Control system has the signals indicating the shielding status. The radiation source would be turn off while the shielding door is open and giving alarms.
♦
Different alarm signals in computer indicate different faults in control systems.
12
6.3 Emergencies ♦
USP switch on automatically while black out during treatment process. Radiation source switch off., 3D treatment couch draw back, treatment process cease, no hurt to the patients.
♦
During the treatment process, if the operators find problems or the patients are abnormal, the operators can push the “emergency operation” button to stop the treatment process. The radiation source is switched immediately. 3D treatment couch draws back. The treatment process is stopped.
♦
When the radiation source can not be stopped due to mechanical fault, manual operation can be used. The radiation dosage is under 1/20 of the operators’ annual radiation dosage when using manual operation.
7. Others 7.1 Long-distance Dosimeters It is installed in the radiation area in the treatment room with 220VAC.
7.2 CCTV 220V 50Hz, including one color monitor, camera and fixation.
7.3 Intercom 220V 50Hz
7.4 Installation The installation of Gyro Knife is executed by Shanghai GammasStar Technology development Co., Ltd. or authorized engineers. The installations include: ♦
Appropriately install the equipment according to treatment room layout including all cables. Connect the equipment to the control system and the provided power output.
♦
Put the radiation source into the treatment head.
13
♦
Acceptance test protocol
♦
Operation training
7.5 Installation Condition 7.5.1 Electric Power requirement: ♦
3 phase 380VAC±10%, 50Hz,7.5kVA
♦
Electricity protection: 30 amp. Air switch
♦
All external connections are connected to electric control system
7.5.2 Environment requirement ♦
Working temperature range: 10°C－40°C
♦
Working humidity range: <90% RH
7.5.3 Treatment room layout requirement Refer to the treatment room layout
7.6 General information 7.6.1 Weight ♦
Standard equipment: 7,000kg
♦
Floor area of the treatment room: >40 m2
7.6.2 Floor Weight Bearing Normal value is 1,800kg/ m2
7.6.3 Standard dimension of all equipment including treatment couch ♦
Shape demension: 4,100mm x 2,000mm x 2,100mm
♦
Maximum equipment height (above the floor after decoration) 2,100mm
♦
Gantry maximum rotating diameter: 1,000mm
♦
Maximum distance of stretch-out to draw-back: 4,100mm 14
CLINIC APPLICATIONS A. 1.
Applications for Neuro Cranial tumors:
Skull-base
tumours/chordoma/chondrosarcoma,
Craniopharyngioma,
Ependymoma,
Glomus Tumour, Haemangioblastoma, Nasopharynx Carcinoma, Pineal Tumour, Primary Low Grade Giloma, Schwannoma, Trigeminal Neuroma; Intracranial neoplasm
2.
Vascular Disorders: Aneurysm, Arteriovenous Malformation, Cavernous Angioma
3.
Functional Disorders: Intractable Pain, Trigeminal Neuralgia, Focal Epilepsy, Parkinson's disease
4.
Psychoneural: Schizophrenia, obsessive-compulsive disorder, addiction onset
B.
Applications for the body 1.
Various benign and malignant tumors in the body:1.
Thoraxďź&#x161; Lung cancer, esophagus cancer, mediastinum cancer
2. Abdominal: Liver cancer, gastric carcinoma, gallbladder cancer, pancreas cancer, gut cancer 3.
Systema urogenitale: Kidney cancer, urinary bladder cancer, prostate cancer, pancreas tumors
4.
Gynecologic tumor: Breast cancer, cervix cancer, ovary cancer, endometrial cancer
15
LIST OF CONTRACTED HOSPITALS 1.
Huaibei People’s Hospital (Anhui province)
2.
Shanghai Changzheng Hospital (Shanghai)
3.
The 98th Hospital of PLA (Army hospital)
4.
Xian Changan Hospital (Shanghai)
5.
Guangxi Minzu Hospital (Guangxi province)
6.
Qian Dong Nan People’s Hospital of Guizhou Province ( Guizhou Province)
7.
The 152nd Hospital of PLA (Army hospital)
8.
Kaifeng People’s Hospital (Henan province)
9.
Zhuzhou Zhi Cheng Bo Ai Hosptial (Hunan province)
10. The Hospital of Wuhan University of Science and Technology (Hubei province) 11. The Hospital of Liaoning University of Chinese Medicine (Liaoning province) 12. Hanzhong 3201st Hospital (Shanxi province) 13. The 306th Hospital of PLA (Army hospital) 14. Xianghuan KangDa Hospital (Hubei hospital) 15. Shiyan People’s Hospital (Hubei hospital) 16. Wu Jing Zong Dui Hospital of Jiang Xi Province (Army hospital) 17. Jinjiang Central Hospital (Fujian province)
16
18. Yangzhou Hospital of TCM (Jiangshou province) 19. Jiangbei Hospital ( Southeast University) 20. The 97th Hospital of PLA (Army hospital) 21. The 4th Hospital of China Medical University ((Army hospital) 22. Xianyang Central Hospital (Shanxi province) 23. Shanghai Cancer Hospital (Shanghai) 24. Jiamusi Cancer Hospital (Helongjian Province) 25. The 256th Hospital of PLA (Army hospital) 26. Shangrao People’s Hospital (Jiangxi hospital) 27. The 3rd People’s Hospital of Huaian (Jiangshou province) 28. Chizhou People’s Hospital (Anhui province) 29. Nanyang Nanshi Hospital (Henan province) 30. The 7th People’s Hospital of Hebei (Hebei province) 31. Liupanshui Kuangwu Hospital (Guizhou province) 32. Weifang Chinese Traditional Medicine Hospital ( Shandong province) 33. Kamayani Hospital (Aqra, India) 34. National Institution of Neurosurgery (Hungary)
There are total 61 contracted hospitals around the world as at 18th April, 2007 …………
17