The ultrasonic osteotome is a medical device that uses high-intensity focused ultrasound technology to perform bone surgery. As a new type of bone surgery equipment, it converts electrical energy into mechanical energy through a special conversion device. After high-frequency ult

What is ultrasonic osteotome?

Ultrasonic osteotome is a medical device that uses high-intensity focused ultrasound technology to perform bone surgery. As a new type of bone surgery equipment, it converts electrical energy into mechanical energy through a special conversion device. After high-frequency ultrasonic vibration, cutting Required for bone tissue . The knife uses high-intensity focused ultrasound technology to convert electrical energy into mechanical energy through the transducer . After high-frequency ultrasonic vibration, the water in the tissue cells in contact is vaporized and the protein hydrogen bonds are broken, thereby removing the components required during the operation. The cut bone tissue is completely destroyed.

The ultrasonic osteotome has tissue selectivity. can change the output power according to the density of different tissues. It can output high power to high-density bone tissue to achieve the purpose of bone cutting, but it will cause relatively little damage to the surrounding dura mater and nerves.

The built-in cooling system of the ultrasonic bone cutter can not only reduce the heat generated by the bone cutter, but also flush the bone particles produced by the osteotomy to make the broken ends neat. When in use, the temperature of the ultrasonic scalpel head is lower than 38°C, and the surrounding propagation distance is less than 200 microns, which will not cause fragmentation or damage to adjacent tissues, thus achieving fine cutting.

Compared with traditional bone cutting instruments, the ultrasonic osteotome reduces bone bleeding during osteotomy. can exert a local hemostasis effect. bone cutting and local hemostasis can be performed at the same time.

Application, characteristics and management categories of ultrasonic osteotome

Ultrasonic osteotome can be widely used in precise and high-risk orthopedic surgeries, and is suitable for the clinical needs of multiple departments: spine surgery , neurosurgery, orthopedic oncology, thoracic surgery, maxillofacial surgery, plastic surgery, trauma surgery (debridement), joint revision (bone cement removal), hand and foot surgery, general surgery, etc. Mainly used in minimally invasive spinal surgery, craniotomy, fracture repair, jaw cyst, dental bad tooth removal and other fields.

This high-intensity focused ultrasound only has a destructive effect on bone tissue with a specific hardness. Not only will it not damage blood vessels and nerve tissue, it can also stop bleeding in surgical wounds, further reducing the wounds of minimally invasive surgeries, and extremely Dadi improves the accuracy, reliability and safety of surgery.

Ultrasonic osteotome has excellent cutting characteristics:

• selective cutting. The ultrasonic frequency of the ultrasonic osteotome only cuts bone tissue. Even if it cuts the sclerotic osteophytes close to the spinal cord, it will not damage the spinal cord. It can be said that it "eats hard but not soft".

• security cut. During extremely precise surgical procedures, the width of micron-level vibration can easily control the cutting action to avoid damage to fragile tissues such as nearby nerves, blood vessels, and mucous membranes due to out-of-control cutting actions.

• cutting without bone damage. There is no heat accumulation during cutting, the temperature can drop below 38°C, and there is no thermal damage to the spinal cord, peripheral nerves, and blood vessels.

• clear cut of view. The characteristic water and air flow of makes the bone cutting line clear and clean, with minimal bleeding.

In July 2015, Notice No. 104 of the Food and Drug Administration's Medical Device Management Office [2015] defined the multi-functional ultrasonic osteotome: consisting of a host machine, a mobile phone, a working tip, an irrigation tube and a pedal set It is used for dental implant osteotomy surgery, sinus augmentation surgery, bone shaping, tooth extraction, residual root, fractured implant removal, periodontal disease treatment, root cleaning and root canal removal in dentistry and oral surgery. It should be supervised as a product managed as a Class III medical device, with a classification code of 6823.

Ultrasonic osteotome product NMPA registration information summary

(The products are all within the validity period; sorted according to approval time; search keyword: "Ultrasound bone")

▲Source: Siyu MedTech compilation, medical device data cloud product Product information database

Three major domestic companies of ultrasonic bone knife

——Woodpecker, Shuimu Canopy, Sumai

(1) Guilin Woodpecker Medical

Guilin Woodpecker Medical Equipment Co., Ltd. was established in 1989 and is now located in Guilin High-tech Information Industrial Park. It is a high-tech enterprise integrating R&D, production and sales of dental products. Guilin Woodpecker has focused on the integration of R&D, production, operation and service in the field of dental medical equipment for 24 years. It is the Guangxi Dental Medical Equipment Engineering Technology Research Center and a leader in China’s dental industry.

According to founder Wu Xunxian, more than 60% of Guilin Woodpecker's products are sold abroad, exported to 137 countries around the world, and more than 50% of the exported products are sold to developed countries.

Ultrasonic bone knife UltraSurgery LED

▲UltraSurgery LED

UltraSurgery LED (National Machinery Notification No. 20173013191) is a core technology product produced by Woodpecker. After 9 years of experience in 77 countries, it has successively passed FDA, unannounced inspection, CE certification, and passed NMPA certification in December 2021. It is suitable for osteotomy and osteoplasty in the dental department.

UltraSurgery The vibration accuracy of the LED work tip is at the micron level, with a lateral amplitude of 30μm and a radial amplitude between 20-200μm. The operation requires only a small amount of force and the cutting path is not restricted. The oscillation frequency is between 24kHz and 29.5kHz, which can effectively cut bone tissue and reduce damage to soft tissue. The main unit is equipped with a handle and seven working tips, which are suitable for various application scenarios of multiple oral bone surgeries such as extraction, periodontal, root canal, and implantation. It has the clinical advantage of 9 years of international practice and has a complete clinical prosecution system. The handle and pump tube can be sterilized under high temperature and high pressure, ensuring a sterile environment during the operation.

product technical parameters:

device is consistent with Directive 93/42EEC

according to EN60601-1 level: IPX1 (host) IPX8 (foot pedal)

intermittent operation equipment: intermittent operation, working for 60 seconds and stopping for 10 seconds

Power supply voltage: ~200-240V 50Hz/60Hz 360mA (Max)

Working frequency: 24kHz ~ 29.5kHz

Flow rate: 25 ~ 100ml/m

Handle wire: It is recommended to use no more than 100 sterilization cycles

Pump tube: 25 It is recommended to use no more than 8 sterilization cycles

Water temperature: The recommended water temperature of the desalted water in the infusion bottle or infusion bag is 4℃

Host size: 330mm×254mm×167mm

Host weight: 3.8kg

Electric shock protection type: Class I

Electric shock protection degree: Type B equipment

(2) Jiangsu Shuimu Tianpeng Technology

Beijing Shuimu Tianpeng Medical Technology Co., Ltd. was established in 2010 and is located in the Zhongguancun National Independent Innovation Demonstration Zone, Beijing. In 2011, it established a production base in the Science and Technology Entrepreneurship Park of Zhangjiagang Free Trade Zone, Jiangsu Province. It is A medical device company focusing on the research, development, production and sales of ultrasonic surgical equipment.

The ultrasonic bone tissue surgery equipment produced by Shuimu Tianpeng supports both open surgery and minimally invasive surgery under channel and transforaminal microscopy. It has obtained marketing authorization in China, EU and the United States; with domestic and European The hospital cooperates closely to establish a professional clinical support team, carry out clinical surgical innovation, and occupy a leading position in the domestic market.

Shuimu Tianpeng is one of the drafting units of the industry standard "Ultrasonic Bone Tissue Surgery Equipment" YY/T 1601-2018; it is responsible for the development of the Ministry of Science and Technology National Science and Technology Support Plan "New Ultrasonic Physical Therapy Technology and Product Development".

Ultrasonic bone dynamic system (ultrasonic osteotome) - XD860A, XD880A

▲ Ultrasonic bone dynamic system XD860A, (National Medical Equipment Approval No. 20193011813) It has passed the domestic NMPA, EU CE and US FDA certifications, serving hundreds of well-known hospitals in China and Europe, and supporting the innovation of various safe, efficient, minimally invasive surgical procedures.

products have the following features:

• is more effective: there are two models and multiple configurations to choose from, supporting open surgery, channel and microscopic minimally invasive surgery.

• Safer: "Smaller amplitude" combined with more than ten kinds of "blunt blades" can effectively protect soft tissues such as dura mater and nerve roots.

• is quieter: The device's operating frequency is 39KHz, which is much higher than the human ear's auditory response range (20Hz~20KHz), creating a quiet surgical atmosphere and protecting the hearing of surgeons and patients.

• More protection: The anti-electric shock level is Class I BF type, and higher levels ensure that doctors and patients during surgery are protected from accidental injuries.

can be applied to many fields:

• spine surgery:

  Laminectomy, laminoplasty, subtotal vertebral body resection, spinal tumor resection , spinal osteotomy and orthopedics, endoscopic disc interbody fusion, percutaneous endoscopic spinal minimally invasive surgery, others More spinal surgery

• extraneural Department:

  Suboccipital craniotomy, zygomatic orbital craniotomy, intraspinal tumor resection, neuroma resection, other more neurosurgery

• Hand and foot surgery:

  Joint prosthesis revision , hallux valgus osteotomy, artificial joint replacement, and more hand and foot surgeries

(3) Beijing Sumai Medical Technology

Beijing Sumai Medical Technology Co., Ltd. was established in July 2007. It was formerly known as the Ultrasonic Medical Instrument Research Center of Tsinghua University and is engaged in the research, development and promotion of high-energy ultrasonic scalpel medical equipment. The company's main R&D and management personnel are all from Tsinghua University. They have rich industry resumes and outstanding achievements. Relying on Tsinghua University's strong academic atmosphere, strong innovative technology platform and high-quality talent resources, it has grown into a company integrating R&D, production and marketing. A high-tech enterprise integrating sales and marketing.

After more than 20 years of active exploration, the company has developed a number of high-tech achievements with independent intellectual property rights, and has won many international, national, provincial and ministerial awards. Most of these achievements have been transformed into ultrasonic medical instrument products.

Sumai Medical's ultrasonic surgery system adopts intelligent modular integration technology, which can integrate functional modules such as ultrasonic osteotome, ultrasonic grinding drill, ultrasonic osteotome minimally invasive system, ultrasonic suction knife, ultrasonic debridement knife and ultrasonic hemostatic knife. The combination allows one machine to be used for multiple purposes, meeting the needs of multiple clinical operations in multiple departments. It is safe and efficient. Modules can be replaced quickly and conveniently during surgery, effectively reducing medical costs.

Ultrasonic osteotome——USI1004A, USI1004, USI1004C

▲USI series ultrasonic osteotome

Sumai Medical’s ultrasonic surgery system (National Instrument No. 20153010459) consists of a host, handle, cutter, foot switch and accessories. The handles include bone cutting handles, bone grinding handles, suction handles, hemostatic handles, and debridement handles. Knives include bone cutting knives, bone grinding knives, suction knives, hemostatic knives, and debridement knives.Ultrasonic hemostatic knives are provided in a non-sterile and sterile manner (the HS5P, HS5PSS, and HS5PTT models of ultrasonic hemostatic knives are disposable). When provided aseptically, they are sterilized with ethylene oxide ; handles and other knives are non-sterile. It must be sterilized before use. The ultrasonic osteotomy tool can only be used once after sterilization and cannot be re-sterilized. It is suitable for open or endoscopic soft tissue incision surgery, central nervous system tumor resection, debridement surgery and orthopedic surgery where bleeding needs to be controlled.

Ultrasonic surgical system accessories - ultrasonic osteotome blade (Beijing Machinery Note 20212010190) has various specifications and models, mainly used in: spine surgery, neurosurgery, bone oncology, maxillofacial surgery, joint surgery, plastic surgery Surgery, otolaryngology, thoracic surgery, etc.

Performance features:

• Safety: has unique tissue selectivity, cuts bones without hurting soft tissue, does not roll, scrape or wrap around soft tissue. It is safe and efficient, and the operation time is greatly shortened.

• High efficiency: adaptive technology, the power can be set flexibly, and can be used for spinal, surgical, surgical, joint, maxillofacial and other surgical needs.

• Accurate: precise cutting, less bone consumption, neat cutting edges, less bleeding, easy to operate, multiple styles of blades, and wide application range.

• Hemostasis: The blade generates local heat and has an obvious hemostasis effect. Bone cutting and local hemostasis can be performed at the same time.