Nanjing Drum Tower Hospital to License Multifunctional Biopsy and Local Drug Delivery Device for Up to RMB 3.09 Million

Recently, Nanjing Drum Tower Hospital released a public notice on the transformation of scientific and technological achievements, proposing to transfer a certain“A Multifunctional Puncture Biopsy and Local Drug Delivery Device”Patented technology, with the assignee being Jiangsu Jianyu Health Medical Devices Co., Ltd. The total proposed transaction price for the technology is capped.RMB 3.09 million (including an upfront fee of RMB 90,000 and sales royalties). The inventor of the technology is Nanjing Drum Tower HospitalProfessor Li Rutian and her team.

This patent pertains to a medical device that integrates percutaneous biopsy and localized, precise drug delivery functions. Its core design comprises a handheld grip, an internal push-pull telescoping mechanism, a drug reservoir chamber, and a puncture cannula equipped with multi-directional injection ports. Constructed from shape-memory alloy, the device contracts after puncture, enabling minimally invasive biopsy while facilitating uniform drug coverage of the target area through lateral multi-port injection, thereby overcoming the limitations of conventional single-point administration. Furthermore, the device features an indwelling structure that eliminates the need for repeated punctures, making it suitable for various clinical scenarios, including local tumor therapy, intracavitary drug administration, and other forms of precise intra-tissue drug infusion.

Currently, minimally invasive diagnostic and therapeutic techniques, represented by tumor treatment, are increasingly widely used in clinical practice. These techniques aim to achieve precise diagnosis and treatment of diseases through minimal trauma or natural body cavities. Consequently, the demand for minimally invasive local drug delivery technologies continues to rise, with their application scenarios expanding from oncology to various other therapeutic settings, including intravascular and intracavitary treatments.

However, in these clinical scenarios requiring precise drug administration, there remains a lack of specially designed devices. Physicians often have to rely on conventional syringes or generic puncture needles for drug infusion. This absence of dedicated instrumentation not only constrains the further development of minimally invasive drug delivery techniques but also directly impacts their reliable clinical application and widespread adoption.

In clinical practice, many treatments require repeated local drug administration. Each administration entails a new puncture and lesion localization procedure. This not only significantly increases the operational burden and time consumption for clinicians but also substantially elevates the risk of complications such as tissue damage, hemorrhage, or infection due to multiple punctures, causing unnecessary pain and safety hazards for patients.

Furthermore, existing technical solutions exhibit significant limitations when confronted with large-volume lesions or drug delivery areas requiring extensive coverage. When using conventional syringes for injection, the drug typically disperses from a single outlet at the needle tip in only one direction. This single-point, unidirectional delivery mode makes it difficult for the drug to permeate uniformly and cover the entire target area, easily resulting in insufficient drug concentration in certain parts of the lesion, which directly compromises the final therapeutic efficacy.

To address the numerous challenges in clinical practice, including instrument shortages, injury and risk caused by repeated punctures, and the inability of single-point, unidirectional drug delivery to fully cover the lesion area, this invention provides an innovative integrated solution.

The core advantage of the device designed in this patent lies inIt integrates two major functions: precise needle biopsy and efficient local drug delivery.In traditional procedures, biopsy and drug administration are typically performed separately and require different instruments.

The device, with the aid of aIntegrated Handle, which houses a retractable telescoping mechanism and a connected drug reservoir. This design enables physicians to perform tissue sampling and drug infusion sequentially after a single puncture and insertion, significantly simplifying the operational workflow and reducing time consumption and positioning errors associated with instrument exchange.

The device’s advanced nature is particularly evident in achieving the goal of precise drug delivery. Its key feature lies in the use of a puncture cannula made from shape-memory alloy. This material possesses shape-memory properties, meaning it can revert to its pre-set original shape from a deformed state under specific temperature conditions.

In this device, multiple cannulas are retractable and conform to the interior of the needle tube in their initial state, facilitating tissue penetration. Upon delivery to the target area, body heat triggers a shape change in the memory alloy, causing the cannulas to extend outward from the side-wall grooves of the needle tube and deploy. This design overcomes the limitation of traditional syringes, which can only deliver medication unidirectionally through a single outlet at the needle tip.

More importantly, each expanded cannula body is equipped with multiple spray holes for drug delivery. As the medication is transported from the reservoir chamber through the injection tube to these cannulas, it disperses uniformly into the surrounding tissue via lateral, multi-directional spray holes.

This multi-point, multi-directional drug delivery mode enables therapeutic agents to cover the entire lesion area more extensively and uniformly. Particularly for large-volume tumors or treatment targets requiring broad infiltration, this approach can effectively address clinical challenges such as uneven drug distribution and insufficient local concentration, thereby holding promise for significantly enhancing the efficacy of local therapy.

Furthermore, the device is specifically designed with an indwelling component to accommodate treatment scenarios requiring multiple doses. At the top of the handle, a section is attached via threaded connection.Non-rigid indwelling catheter made of flexible polymer materials. After completing the initial puncture, drug administration, or biopsy, the internal steel needle cannula and handle assembly can be withdrawn as a single unit, while the flexible indwelling catheter remains in place within the original puncture tract.

During subsequent treatments, medication can be directly infused into the target area via the pre-placed indwelling catheter lumen, eliminating the need for repeated punctures. This approach fundamentally avoids the repetitive tissue trauma caused by multiple punctures, reduces risks such as bleeding and infection, and alleviates the workload for physicians.

In terms of convenience and safety in clinical practice, the device incorporates multiple human-centered design features. For instance, the tip of the puncture cannula is designed with a triangular prism shape and features a matte surface. This structure not only enhances puncture capability but also provides clearer visualization under imaging modalities such as computed tomography (CT), enabling physicians to confirm the instrument’s position in real time during procedures.

On the outer wall of the needle barrelEquidistant Groove Ring, which can enhance ultrasound reflection and improve visibility under ultrasound imaging. The prisms and snap-fit structures on the telescopic body ensure stability during push-pull operations, enable positional locking at varying degrees of opening, and allow physicians to precisely control the extension status of the puncture tube and the range of drug delivery.

In summary, this patented device, by virtue of its innovativeShape-Memory Alloy Multi-Directional Puncture Drug Delivery System with Implantable Design, it not only overcomes the core technical challenges of traditional local drug delivery, such as unidirectional administration and incomplete coverage, but also significantly improves the overall efficiency and precision of minimally invasive interventional diagnosis and treatment through its integrated and human-centered design. Meanwhile, it enhances patient tolerance, demonstrating significant clinical practical value and broad application prospects.

In response to the urgent demand in today’s minimally invasive diagnosis and treatment market for interventional devices that are precise, efficient, and capable of achieving uniform drug coverage within lesions, multiple medical device companies both domestically and internationally are actively developing related product pipelines through diverse technological approaches, jointly driving technological advancement and clinical innovation in this field.

In the international market,BD (Becton, Dickinson and Company)BD has made in-depth strategic investments in precision diagnosis and treatment technologies, such as needle biopsy. The company has prominently launched its flagship product for breast care—the MARQUEE® disposable integrated guidance biopsy needle. This product has received regulatory approval for market launch and boasts a broad range of indications, being compatible with ultrasound, CT, and X-ray guidance.

In China,Jingmai MedicalEstablished a thoracoabdominal solid tumor treatment system integrated with surgical robots. Its flagship product, the Thoracoabdominal Precision Interventional Surgical Navigation System, has achieved significant results. This system enables precise localization and biopsy, and is compatible with various novel minimally invasive tumor therapies, including particle implantation and thermal ablation (both hot and cold).

To date, the system has completed a multi-center clinical trial involving nearly 200 randomly enrolled cases at several hospitals, including Peking Union Medical College Hospital and Shanghai Ruijin Hospital.

RayTouch TechnologyFocusing primarily on the field of precision puncture surgical robots, the company’s self-developed CT-guided lung puncture surgical robot assists physicians in rapidly performing 2D and 3D image reconstruction of the lungs and planning the optimal puncture path. The robotic arm moves precisely along the planned trajectory, enabling accurate needle placement directly into the lesion in a single pass.

Currently, the product has obtained a production license and is being trialed in collaboration with more than 10 Grade A tertiary hospitals across China, including Shanghai Oriental Hospital, the First Affiliated Hospital of China Medical University, and Peking University Shenzhen Hospital.

Looking ahead to the future of the industry, the commercialization pathway of this technology will be deeply integrated with the overall development trends of China’s medical device sector.

On the one hand, the industry strategy clearly positions innovation and overseas market expansion as its core directions. Innovative products with genuine clinical value are not only key to helping companies navigate the domestic price adjustment cycle smoothly but also serve as a critical foundation for entering overseas markets, which are characterized by lower price sensitivity and stronger purchasing power.

On the other hand, the scope of volume-based procurement (VBP) for high-value medical consumables continues to expand, paralleling trends in mechanism optimization such as anti-involution measures. This indicates a growing market demand for differentiated innovative products that can fill gaps and address unmet clinical needs.

Therefore, the long-term development of such products, which integrate precision biopsy with uniform drug delivery capabilities, depends not only on the maturity of the underlying technology but also on their ability to precisely align with clinical value and market demand within an increasingly refined industry landscape.