Innovation and R&D

Hicren is the first manufacturer of curved vertebroplasty products to obtain NMPA and CE approvals. It is also the most comprehensive surgical instrument manufacturer of angled and traditional vertebroplasty solutions in China.

Vertebroplasty

The curved vertebroplasty technology system developed by HICREN can realize convenient unilateral positioning, puncture, drilling, expansion, filling and other operations, effectively solving the problems of high puncture risk, uncontrollable bone cement dispersion and long operation time of traditional vertebroplasty surgical instruments. On this basis, HICREN further carried out the research and development of vertebroplasty implants and artificial intelligence vertebroplasty systems, bringing more innovative technologies and products to clinical and patients.

 

Construction and Innovation of the Technical System of the Curved Vertebroplasty

As the pioneer and leader of curved vertebroplasty technology, HICREN has built a complete curved surgery solution and technical system, achieving the bilateral surgical results by unilateral puncture, bone cement whole-vertebral directional multi-point low-pressure injection, and bone cement evenly dispersed along the arc channel. At the same time, the R&D team is promoting the innovative project of curve channel tools and integrated tools, which will significantly improve the convenience of establishing curve channels in rigid bone, and achieve the versatility of surgical instruments, so as to achieve the goals of reducing instrument configuration, improving surgical efficiency, and reducing the exposure time of operators.

 

Development and Research of Vertebroplasty Implant Technology

Focusing on the clinical problems such as the height retraction of the vertebral body after distraction and the leakage of bone cement, the new curved vertebroplasty implant technology developed by HICREN, combined with the unique anti-leakage mechanism, will achieve breakthrough clinical effects such as full vertebral body expansion through unilateral implantation, the height maintenance after the vertebral body distraction, the directional dispersion of bone cement and the reduction of bone cement leakage.

 

Artificial Intelligence Vertebroplasty Technology

Intelligentization is the development trend of orthopedic surgery. Vertebroplasty combined with artificial intelligence can achieve the goals of automatic target navigation puncture, precise depth control, precise vertebral expansion, and controllable bone cement filling. The research and development of this technology can greatly reduce the difficulty and risk of surgery.

Minimally Invasive Spinal Surgery

Traditional open spine surgery has problems that affect the postoperative recovery of patients, such as the need for extensive dissection of soft tissue, long-term traction during surgery, large surgical trauma, and the destruction of the posterior stable structure. HICREN is committed to developing digital, intelligent, and minimally invasive spine diagnosis and treatment technology with the characteristics of small incision and fast recovery, so as to make the operation simpler and recovery faster.

 

Minimally Invasive Interbody Fusion Technology

Performing interbody fusion in a minimally invasive manner has always been a difficult point in spinal fusion technology. HICREN has developed a minimally invasive fusion cage that can complete interbody fusion under direct vision. The fusion cage can enter the intervertebral space through a very small endoscopic channel, and achieve height adjustment with a unique distraction mechanism. The minimally invasive fusion cage has a large distraction ratio, can obtain sufficient space for bone grafting in the cavity and contact area with the upper and lower endplates. It can provide more stable vertebral support, and significantly improve the fusion rate. The innovation and R&D of this product technology will promote the leap forward of fusion technology from small incision to minimally invasive surgery, and truly realize the minimally invasive and visualized spinal fusion surgery.

 

Transpedicular Fusion Technology

The transpedicular fusion technology is another innovation and breakthrough in spinal fusion and fixation. Through extremely small incision, a channel that through the multi-segment vertebral body and intervertebral space is formed, and combined with bone cement and other biological materials to achieve minimally invasive rapid fusion and fixation between the vertebral bodies. This operation innovates the traditional fusion fixation technology, has the advantages of simple operation, small trauma, fast recovery, good effect, and has significant clinical and economic value.

 

Minimally Invasive Fixation Technology

In the technical field of spine minimally invasive internal fixation products, HICREN focuses on the development of minimally invasive decompression, minimally invasive fixation and minimally invasive instruments, which can realize the unilateral approach and bilateral decompression under the minimally invasive working channel. The percutaneous screw placement and rod passing is more accurate and reliable, with the advantages of small incision, convenient operation, stable performance, and so on. At the same time, it can effectively reduce or avoid the damage to the posterior spinal bone structure, and maintain the integrity of the posterior joint and ligament. The iatrogenic injury caused by surgery is minimized, the pain of patients is reduced, and the rehabilitation period of patients is shortened.

Surgical Devices and Consumables

The treatment of spinal diseases has gone through many development stages, such as conservative treatment, interventional surgery, open surgery, endoscopic minimally invasive surgery, etc. At present, as an important part of spinal minimally invasive technology, spinal endoscopic technology is in a rapid development stage. This technology system has a wide range of categories, a long learning curve for the operator, a high end-user purchase price, and difficult after-sales service, which makes it difficult to popularize the technology. The innovation and R&D of the surgical devices and consumables product line of HICREN aims to solve the above pain points and needs by innovating the product structure and operation mode, and accelerate the popularization and development of spinal endoscopy and related minimally invasive device.

 

Innovative Minimally Invasive Spinal Technology

HICREN closely followed the market demand, focused on the highly integrated spinal endoscope solution, integrated with the existing spine minimally invasive technology, and achieved the transformation of the spine endoscope technology from complex to simple through innovative structural breakthroughs. It makes the scope of clinical application wider, the compatibility with instruments higher, improves the flexibility, convenience and safety of intraoperative operation, significantly shortens the operation time, reduces the learning curve of the operator, improves the service life of the endoscope and instruments, and reduces the cost of customer procurement and after-sales maintenance.

 

Safe and Controllable Osteotomy Technology

The innovation of intraoperative osteotomy and bone grinding technology is focusing on the goal of high efficiency, accuracy and safety. HICREN focuses on this direction. Aiming at the problems that the existing technology cannot be accurately controlled, the risk of soft tissue injury is high, and the resulting surgical effect is not ideal, it adopts a high-speed and intelligent computing core, combined with innovative product technology, to monitor and display the tissue structure status of the working site in real time, and feedback and remind the osteotomy trend, so as to realize the minimally invasive, controllable and intelligent leap of osteotomy technology.

Sports Medicine

Clinicians and orthopedic practitioners have been plagued by problems such as inaccurate positioning of the bone canal, improper selection of the graft specification, insufficient fixation strength, and difficulties in the operation of special parts under the endoscope. In view of these pain points, HICREN focuses on innovation and R&D in the fields of ligament reconstruction, soft tissue repair, bone tamponade technology, and so on. Through technological breakthroughs, it can solve the relevant problems faced by the clinic to the greatest extent.

 

Ligament Reconstruction Direction

In order to improve the stability of self-locking structure during ligament reconstruction, the innovative R&D of double compression self-locking technology can effectively improve the reliability of self-locking structure, avoid the detachment and loosening of self-locking knot after surgery, significantly improve the initial fixation strength and stability of implants, effectively avoid the loosening/failure and other complications after cruciate ligament reconstruction during the postoperative healing process, reduce the probability of secondary surgery, and help patients better return to daily life faster.

 

Soft Tissue Repair Direction

Arthroscopic minimally invasive surgery is an important way to achieve small injury and fast recovery in orthopedic sports medicine, but it is difficult to achieve the ideal treatment effect in some treatments due to the limited operation space and complex operation steps. The application of precise angle adjustment technology and continuous puncture technology can expand the treatment scope, broaden the operation space, reduce the operation steps, reduce the operation difficulty and risk of the operator, shorten the recovery time of patients, and enable the promotion and development of arthroscopic minimally invasive surgery technology in a wider range.

 

Bone Tamponade Technology Direction

In order to strengthen the fixation strength of the soft tissue-bone interface and reduce the risk of unexpected movement of the graft, the bone tamponade fixation technology was innovatively developed. The bone tamponade applys a new type of bone filling material and has a unique structure, which can effectively reduce the gap between bone and soft tissue, enhance the fixation strength of the soft tissue-bone interface, and reduce the incidence of complications. The bone growth factor released by the new bone filling material can effectively promote bone growth, promote the combination of bone and soft tissue, and avoid the problems of partial contact or long-term loosening that may occur during the combination of soft tissue and bone.

 

Biomedical Material

Regeneration and reconstruction are the development trend of biomedical materials. HICREN is committed to developing and launching innovative biomedical products and technologies such as new absorbable high-strength bone cement, bone induction materials and biomimetic bone materials to meet the new demands of bone repair materials in clinical practice.

 

Absorbable High-strength Bone Cement

The repair and reconstruction of osteoporotic fracture have always been a difficult problem in the field of modern orthopedics. As a filling material, calcium phosphate inorganic bone cement (CPC) degrades slowly and has poor bonding performance, which is difficult to meet the needs of modern minimally invasive surgery. An injectable bone cement with excellent performance is urgently needed clinically. HICREN has developed a new high-strength degradable bone cement through continuous optimization of bone cement formula, preparation process, and sterilization process. This bone cement has high mechanical properties and good operability, and has an osteoinductive function which can promote bone differentiation and regeneration.

 

Osteoinductive Regenerative Material

Bone induction and regeneration materials have the ability to induce the directional differentiation and proliferation of undifferentiated cells to osteoblasts or cartilage cells, promote the differentiation and maturation of osteoblasts, participate in the growth, development and reconstruction of bone and cartilage, and accelerate the repair of bone defects. Through biological fermentation and purification technology, HICREN produced bone induction active materials, and combined the materials with slow-release media to obtain composite bone induction regeneration materials. During the slow degradation of the material, the continuously released active substances induce the growth of new bone tissue to achieve the goal of rapid reconstruction.

 

Biomimetic Bone Material

Bionic bone material refers to a new type of composite material that simulates the formation environment of natural bone in vitro, obtains nano-hydroxyapatite crystals with the same size as natural bone through nanotechnology, and combines with collagen to achieve the composition, structure and function approaching natural bone at different scales (micro and macro). Through protein self-assembly technology, HICREN organically combines inorganic bone filling materials with natural polymers to obtain a new bionic bone material, which can induce bone tissue regeneration and achieve permanent repair of damaged and diseased bone tissue.

Surgical Robot

The existing surgical robot products that enable vertebroplasty and spinal fixation surgery are generally refitted from industrial mechanical arms. In order to pursue high accuracy, the structural stiffness of the robot is required to be high, resulting in the weight and size of the mechanical arm is too large. At the same time, safety is a major problem in the crowded and unmodeled environment of the operating room. Therefore, the disadvantages of large volume, complex operation, long time consumption and high price have hindered the development of the surgical robot market and technology promotion to a certain extent. The orthopedic surgical robot under HICREN leads the design from a clinical perspective, focusing on miniaturization and convenience. Compared with the existing products in the market, it fully optimizes the operation module and operation process, matches all kinds of surgical accessories required by the clinic, and meets the practical needs of clinical users with differentiated technical features and humanized product design while solving the drawbacks of the existing products.
After independent research and development, HICREN is about to launch two innovative products, remote bone cement robot and "intelligent woodpecker" spinal surgery robot.

 

Remote Bone Cement Robot and Innovative Medical Device Consumables Overall Solution

For patients with osteoporotic vertebral compression fracture, currently, vertebroplasty is mainly used for surgical treatment. There are many problems during the operation, such as uncontrollable bone cement dispersion and high leakage risk. At the same time, the operators continued to be injured by radiation. According to statistics, without protective measures, After an average of 34 vertebroplasty operations, the operators exceeded the annual total radiation allowance. In response to the above problems, HICREN carried out technical research, developed a remote bone cement robot and an integrated solution for innovative medical device consumables, and controlled the dispersion of bone cement through multi-point directional injection technology, reduced the risk of bone cement leakage through precise quantitative injection technology. Through the whole-process remote control technology, the radiation exposure time of the operator is greatly reduced and the radiation injury of the operator is reduced.
The robot has an electric injection device, which can control the bone cement injection through the button. The use of micro-mechanical fixed arm is convenient for installation, flexible for deployment, and safe for cooperation. It can be combined with the navigation puncture positioning system for all-round empowerment. The bone cement robot specially cooperates with the company's unique series of angled vertebroplasty products, which can realize remote, accurate, multi-point and quantitative injection, reduce the leakage rate of bone cement, reduce X-ray radiation, simplify the operation of doctors, and complete the operation quickly, efficiently and safely.

 

"Pecker Spine" Spinal Surgical Robot

Spinal surgery robots empower doctors' "hands" (robot arms), "eyes" (navigation) and "brains" (intelligent planning), and because of their advantages of simple operation and short learning curve, they can effectively solve the clinical pain points that surgeries rely too much on the experience of the surgeon and standardized and repeatable operations cannot be achieved in traditional surgery. The "Pecker Spine" spine surgery robot independently developed by SEMR, a subsidiary of HICREN, and INS, a European partner, is equipped with a highly targeted surgical planning and navigation system, which has the functions of pre-operative planning, intra-operative micro-robotic arm positioning and real-time navigation. Among them, the micro-robotic arm is mainly responsible for surgical execution and operation, and can move precisely, flexibly and stably. The intelligent surgical planning function can recommend the best surgical plan parameters for the corresponding vertebral body according to the patient's condition, so as to optimize and improve the effectiveness and stability of the operation. The real-time navigation function has been improved for the pain points of "invisibility, inaccuracy, and unstability" in spinal surgery, and a computer-aided navigation system suitable for orthopedic surgery has been developed to realize cross-modal registration of navigation, tracking and positioning, intraoperative guidance and calibration, so as to ensure the accuracy of surgery.
"Pecker Spine" has built a good medical-industrial cooperation system, overcomes the difficulties in multidisciplinary fields, and has achieved important breakthroughs in core technologies such as the development of highly dexterous and lightweight robotic arms, intelligent planning and navigation algorithms.

 

Highly Dexterous and Lightweight Robotic Arm

Existing large medical robots apply industrial robotic arms, which are bulky and have uncontrollable range of motion with high risk and high cost. The micro-surgical robot developed by HICREN has significant advantages: it is small in size and weighs only 2 kg, and can be fixed on the track beside the bed. The absolute movement accuracy can reach 0.2 mm, and it can reach 6 degrees of freedom and a moving range of 40 cm. The interval is controllable and meets the needs of clinical operations.

 

Intelligent Planning

Comprehensive surgical planning can be carried out in advance through the pre-operative planning software. The planning software can intuitively restore the patient's real physiological characteristics and bone structure on the computer screen, and can directly simulate the placement of virtual implants (such as screws), surgical incisions, and simulate post-operative corrective effects through the software, reducing the risk of complications from nerve damage. At the same time, patients can clearly understand the operation method before the operation, have a visual and intuitive cognition of the operation effect. Therefore, the psychological burden can be reduced, and better doctor-patient communication can be achieved.
Surgical navigation is the core module of the surgical robot, which accurately corresponds the patient's pre-operative or intra-operative image data to the patient's anatomical structure on the operating bed, tracks the surgical instruments during the operation, updates the position of the instruments on the patient's image in real time in a virtual form, allows the doctor to see the position of the instrument relative to the patient's anatomical structure, and makes the surgical operation faster, more accurate and safer.

Digital Orthopedics

Orthopedic surgery is a typical hard tissue operation, with complex and diverse operation methods, high risk of operation, high requirements for doctors' clinical experience, and problems such as large incision, high radiation, long operation time and slow postoperative recovery under traditional surgical conditions. With the continuous innovation and development of navigation and robot technology, orthopedic surgical robots have become the core equipment and technology to promote accurate and minimally invasive orthopedic treatment, and have been gradually applied to clinical practice. The combination of orthopedic surgery robot and AI makes it possible to treat diseases with minimally invasive, intelligent, safe, accurate and personalized, thus effectively making up for the shortcomings of traditional orthopedic surgery. SEMR is a leader in AI technology enabling orthopedics. By applying machine learning and deep learning technology to preoperative planning, diagnosis and navigation, it has built an internationally leading Chinese intelligent product, effectively improving the accuracy of surgery and bringing benefits to the majority of patients.

 

Application of AI in Preoperative Planning of Spinal Surgery

SEMR is developing a set of AI-assisted orthopedic 3D planning system based on AI in-depth learning, which is applied to preoperative planning of spine surgery.
The system has high accuracy and repeatability. The key technology is to achieve accurate segmentation, recognition and positioning of spine based on deep learning neural network model. In addition, the surgical plan will also be automatically identified and formulated through deep learning neural network.

 

5G Remote Surgery Scheme

Remote 5G preoperative planning based on cloud technology and AI algorithm
Upload the preoperative CT by the surgery hospital, combining the cloud AI analysis, the planning hospital experts review and confirmation, and then download the planning results and import them into the surgery robot for actual surgery.
Real-time remote surgery based on 5G technology and multi-channel network optimization
Real-time operation is guided through dedicated audio and video network channel, real-time planning and screen operation network channel, and mechanical arm control network channel.

 

Application of Virtual Reality Technology in Spinal Surgery

Virtual reality technology can provide users with a fully immersive, 3D panoramic image display. As the pioneer and leader of AI technology in spine surgery, SEMR applied VR display technology to clinical teaching of spine surgery and boldly explored the teaching effect of this method.
SEMR introduced the navigation system based on AR technology into the minimally invasive treatment of spinal surgery to improve the accuracy and efficiency of pedicle screw insertion. The operator can quickly perceive the depth, direction and spatial location of pedicle screw placement. This system simplifies the complicated screw placement process and improves the implantation accuracy.