Sichuan University Licenses Bone Cement Delivery Device for RMB 150,000 Plus 6% Royalty to Changzhou Jishuo Medical

Recently, West China Hospital of Sichuan University released a public notice on the transformation of scientific and technological achievements, proposing to transfer an authorized invention patent“Bone Cement Injection Device”Transferred through negotiated pricing. The transferor in this proposed transaction is West China Hospital of Sichuan University, and the transferee is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. The proposed transaction price is RMBRMB 150,000 plus a 6% commission on sales revenue。

This patent is held by West China Hospital, Sichuan UniversityMedical Technology Team Led by Zeng Jiancheng and Xie TianhangR&D completed.

The Assignee of This Patent TechnologyChangzhou Geasure Medical Apparatus and Instruments Co., Ltd., is a high-tech enterprise dedicated to the research and development, manufacturing, and sales of high-end active and passive medical devices and surgical instruments in fields such as orthopedics and dentistry. Located in Changzhou, Jiangsu Province—a key cluster for China’s medical device industry with a complete industrial supply chain—the company is committed to introducing and commercializing advanced clinical patented technologies to develop high-quality medical device products that comply with national regulations and industry standards. Its business scope covers the entire process from product design and development through precision machining and manufacturing to market promotion, supported by a standardized quality management system and robust production capabilities.

The “bone cement injection device” being commercialized here is a significant proprietary medical device developed by the inventor team to address the urgent clinical need for precise and safe control of bone cement injection volume and rate during procedures such as percutaneous vertebroplasty (PVP).

In spinal surgery,Interbody FusionIt is a common surgical procedure used to treat conditions such as lumbar disc herniation and spinal instability. The core step of this surgery involves the initial removal of diseased intervertebral disc tissue. The intervertebral disc is a cartilaginous structure located between adjacent vertebral bodies, serving to cushion pressure and facilitate spinal movement.

Following resection, a device known as an “interbody fusion cage” is implanted into the remaining intervertebral space, with bone graft material packed inside or around it. This serves to replace the function of the original intervertebral disc, with the expectation that the two adjacent vertebral bodies will ultimately fuse into a single unit through the bone graft, achieving permanent stability.

The selection of bone graft materials is crucial to the success of fusion.Currently, there are three main categories of bone graft materials commonly used in clinical practice: autologous bone harvested from other sites of the patient’s own body (such as the iliac crest), allogeneic bone derived from human donors, and synthetic bone substitutes. These materials are packed into interbody fusion cages and then implanted into the intervertebral space.

However, current clinical protocols face a significant challenge: some patients suffer from osteoporosis (a disease characterized by decreased bone density and strength), or sustain unavoidable damage to the cartilaginous endplates forming the superior and inferior walls of the intervertebral space during surgery. The endplate is the bony surface of the vertebral body adjacent to the intervertebral disc, which bears the pressure exerted by the fusion cage.

When the endplate structure is weak, the interbody cage may gradually subside or even collapse into the cancellous vertebral body postoperatively, a phenomenon known as "subsidence," which can lead to loss of surgical height, nerve compression, and even fusion failure.

To address this issue, an innovative technical solution has been proposed:Reinforce the stress endplates in direct contact with the interbody fusion cage using polymethyl methacrylate (PMMA) bone cement.PMMA bone cement is a self-curing biomaterial widely used in orthopedics that hardens after injection, providing immediate mechanical support. The specific technique involves drilling holes into the adjacent superior and inferior vertebral bodies after cage insertion, and injecting a small amount of bone cement through these channels into the intraosseous region beneath the endplates, thereby locally reinforcing the bony structures that support the cage.

However, this presents a new technical challenge. To achieve the desired clinical outcomes,The distribution range of bone cement must be precisely controlled.On one hand, bone cement needs to be concentrated in the stress-bearing areas where the endplates contact the interbody cage to enhance support; on the other hand, its diffusion must be strictly limited to prevent bone cement from infiltrating the central region of the cage designed to hold bone graft materials.

Because the bone graft area requires adequate blood supply to promote new bone growth, and the infiltration of bone cement would hinder this biological fusion process. Therefore, this new application scenarioThe bone cement injection device is required to achieve extremely precise "directional" and "quantitative" control.

In the prior art, for example, another bone cement injection device disclosed in a Chinese patent employs relative rotation of inner and outer cannulas to align injection ports at different levels, thereby achieving directional injection. However, this device primarily addresses the directional issue of “where to inject,” but struggles to precisely control the quantitative issue of “how much to inject.”

More importantly, its design fails to adequately meet the unique requirements for a delicate balance between “endplate reinforcement” and “preservation of blood supply to the bone graft area” in the aforementioned new scenarios, thereby limiting its clinical applicability.

To address the limitations of existing bone cement delivery devices in the new clinical application scenario of “bone cement reinforcement of the vertebral endplate,” the present invention provides a novel bone cement delivery device.

The core objective of this device isAchieve Precise Injection，While reinforcing the endplates to prevent cage subsidence, avoid the central bone grafting area of the cage to preserve the blood supply essential for bone growth, ultimately achieving a balance between “endplate reinforcement” and “protection of blood supply to the bone grafting area.”

The basic technical solution of the invention is as follows: The device mainly consists of a tube body structure and a push rod. One end of the tube body structure is the proximal end, and the other end is the distal end.

Its innovation lies inThe outlet for bone cement is not located at the very tip of the cannula but is instead opened on the lateral wall of the distal end.. This lateral outlet design can effectively reduce the risk of accidental bone cement leakage out of the vertebral body caused by excessive forward injection pressure.

More critically, the device is designed to simultaneously form two lateral outlets, which are located on the same side of the tubular structure and arranged at a certain interval along the axis of the tube. This layout aims to ensure that the injected bone cement is distributed precisely in the stress-concentration areas where the upper and lower ends of the interbody fusion cage contact the vertebral endplates, thereby reinforcing the support.

Meanwhile, since the injection sites avoid the central cavity of the interbody cage (i.e., the bone graft area), they do not interfere with blood supply and new bone growth in this region. The two outlets can operate simultaneously, which significantly shortens the injection time, reduces surgical duration, and lowers the patient’s radiation exposure from intraoperative CT monitoring.

To achieve greater flexibility and adaptability, the tubular structure of the invention may adopt a double-cannula design, comprising an outer tube and an inner tube that are rotatable relative to each other.

The outer tube sidewall is provided with a first injection port structure, and the inner tube sidewall is provided with a second injection port structure. By rotating the inner tube or the outer tube, the two sets of port structures can be aligned at different positions, thereby forming different injection modes.

For example, when the pore structures of the two groups are aligned at specific positions, the aforementioned two outlets can be formed on the side wall; this is referred to as the “first alignment state,” which is specifically designed for endplate reinforcement. Furthermore, by rotating to other positions, a “second alignment state” can be achieved, in which only one lateral outlet is formed, or a “third alignment state,” in which a forward-facing outlet is formed at the distal tip of the tube body.

This multi-modal design significantly expands the device’s range of applications, enabling it to be used not only for specific endplate augmentation but also for other clinical scenarios that may require single-point injection.

Considering the individual differences in patient vertebral body dimensions, the invention furtherProvides an adjustable outlet spacing functionSpecifically, this can be achieved by providing an axially extending slot on one tube (e.g., the inner tube) and multiple sets of holes with different pitches on the other tube. During rotational adjustment, the slot can align with different hole sets, thereby changing the axial distance between the two outlets to better match vertebral bodies and fusion cages of varying sizes.

To ensure the injection depth is safe and accurate,The device is provided with a protrusion on the tube body structure as a limiter.. When the cannula is inserted into the vertebral body to the predetermined depth, the protrusion engages with the surface of the vertebral body, preventing over-insertion.

Based on the common dimensions of the human lumbar spine, the preferred distance from the protrusion to the foremost end of the tube body is38 mm to 48 mm. To further enhance applicability, the protrusion may also be designed in a form that allows it to slide and lock on the tube body, enabling the operator to make real-time adjustments based on the patient’s specific anatomical structure.

In terms of quantitative control,The invention also allows for the connection of a supplementary tube to the rear end of the device.. The refill tube has a larger capacity, allowing for pre-loading of more bone cement to avoid frequent device changes during surgery due to material shortage. The push rod and the refill tube are connected via a threaded fit, enabling steady advancement of the bone cement by rotating the push rod.

This design ensures a fixed volume of advancement with each rotation, thereby achieving precise, quantitative control over the bone cement injection volume and further meeting the stringent requirements for “precision” and “controllability” in new application scenarios.

In summary, the present invention provides a solution specifically designed to address the challenge of “endplate reinforcement after interbody fusion” through an innovative dual lateral outlet configuration, an adjustable multi-mode injection design, safe depth limitation, and a quantitative advancement mechanism. It effectively overcomes the limitations of existing instruments, offering a reliable, specialized tool for precise, safe, and efficient clinical procedures.

In light of the trend toward minimally invasive and intelligent orthopedic surgical instruments, as well as the higher clinical demands for surgical safety, convenience, and patient prognosis, relevant R&D teams are continuously expanding their product pipelines. They are committed to developing a series of innovative medical devices designed to enhance the precision and safety of orthopedic surgeries, covering a broader range of orthopedic treatment scenarios from spine to joint procedures.

Yueming Qianli (Suzhou) Medical Technology Co., Ltd.Focusing on the medical device sector, its developed bone cement injector has received approval for registration application from the Jiangsu Provincial Medical Products Administration. The product consists of the injector body, adapter assembly, extension tube assembly, funnel, and other components. It is supplied sterile, sterilized with ethylene oxide, and intended for single-use only. It is designed to be used in conjunction with vertebroplasty instruments to facilitate the delivery and injection of bone cement during surgical procedures.

KaitaiFocusing on the field of minimally invasive interventional medical devices, successfully developedSterile Bone Cement ApplicatorThis scientific achievement has been awarded the Class II Medical Device Registration Certificate for the product by the Shanghai Municipal Medical Products Administration. The sterile bone cement injector consists of two components: an outer tube and a plunger. Based on the structural configuration of the distal end, the outer tube is available in five types: flat tip, serrated, single-side opening, beveled, and threaded. The metal inner rod, metal outer rod, and threaded sleeve are manufactured from 06Cr19Ni10 medical-grade stainless steel, while the plunger handle and outer tube handle are made of ABS material. The product is intended for single use, sterilized with ethylene oxide, and has a shelf life of three years. It is designed for use by medical institutions to deliver bone cement during minimally invasive orthopedic interventional procedures, such as vertebroplasty and kyphoplasty. Currently, the product has passed review in compliance with medical device market access regulations and has completed the registration and approval process.

From an industry trend perspective, orthopedic surgical instruments are evolving toward minimally invasive and precise approaches. The development of specialized instruments for specific scenarios, such as vertebroplasty and endplate reinforcement, has become a critical pathway to enhancing surgical safety and outcomes. In the future, intelligent injection systems integrating features like real-time pressure monitoring and precise flow control are expected to further drive technological advancements and clinical applications in this field.