Announcement of the Results

To address the increasingly complex nature of liver diseases and the refined demands for interventional diagnosis and treatment, Manners Technology has launched its "On-Demand Precision" Mandic liver biopsy needle customization service platform. This platform enables clinicians to customize the length (from 7cm to 20cm), diameter (from 14G to 20G), needle tip slope angle (15° - 30°), and handle configuration of the needle based on specific patient anatomy, pathological conditions, or research requirements online. The first collaborative project has provided dedicated ultra-fine biopsy needles for a multi-center study on non-alcoholic fatty liver disease (NAFLD) in children, successfully obtaining high-quality samples for children weighing as low as 15kg.

Research and Development Background and Challenges

The standardized Menchini needle can meet the routine biopsy needs of most adult patients, but it becomes inadequate when dealing with diverse clinical challenges:

  The problem of adapting to special populations: Children, extremely obese, or cachectic patients have greatly varying abdominal wall thickness, intercostal space width, liver size, and location. Standard-sized needles may be too long, too thick, or too short, increasing the difficulty and risk of the procedure.

  The challenge of sampling for specific lesions: For deep nodules, lesions close to major blood vessels or bile ducts, different lengths and rigidity of needles are needed for precise positioning and sampling.

  Special requirements for research: Certain cutting-edge studies may require paired samples from specific areas (such as the perivenous area and central venous area of the portal vein) or a larger sample size for multi-omics analysis, which impose non-standard requirements on the sampling accuracy and capacity of the needle.

  Doctor preferences and habits: Different doctors have different preferences for the feel, weight balance, and grip method of the needle based on their own experience and surgical style.

Core Technological Innovation

The core of this customized platform lies in the deep integration of "modular design" and "flexible manufacturing system":

  Parametric 3D Design Library: A 3D digital model library covering all customizable parameters has been established. Doctors or researchers can intuitively select and combine parameters (such as length 16cm, tube diameter 18G, needle tip angle 20°, lightweight handle with thumb rest) through the online configuration interface. The system will generate real-time 3D renderings and main technical specifications of the product.

  Flexible CNC Machining and Laser Microprocessing: The production line is equipped with multi-axis CNC machines that can be quickly reprogrammed and high-precision laser welding machines. After receiving a customized order, the system automatically generates processing codes, retrieves corresponding specifications of pipes and components from the standardized semi-finished product library, and conducts integrated flexible production of cutting, grinding, welding, and polishing, achieving efficient and economical manufacturing of small batches or even single-piece products.

  Anatomical Adaptation Service Based on Patient Imaging: For extremely complex cases (such as severe spinal curvature resulting in abnormal anatomical structures), the platform provides advanced services. Engineers can analyze the patient's CT or MRI DICOM data, perform 3D reconstruction, simulate the puncture path, and accordingly recommend or specially design the most suitable needle length, curvature (within limits), and puncture point.

Mechanism of Action

Customization optimizes clinical outcomes by achieving a precise match between the "devices and the context":

  Precise size matching: For children, we offer shorter and thinner needles (such as 19G), which can minimize the trauma to the delicate tissues, reduce the risk of bleeding, and accommodate their narrow rib spaces. For obese patients, we customize longer needles to ensure they can penetrate the thick subcutaneous and fatty layers to reach the liver.

  Optimization of needle tip geometry: For severely fibrotic livers such as those with liver cirrhosis, a needle tip with a smaller inclined angle (such as 15°) can be selected. This more "sharp" design can penetrate the tough tissues with less puncture force and reduce needle path deviation. For soft livers such as fatty liver, a slightly larger angle may be more conducive to cutting.

  Special designed for scientific research purposes: For example, we customize double-chamber biopsy needles, which can obtain tissue samples of two different depths successively or simultaneously in one puncture, for studying the regional heterogeneity of liver diseases. Or we customize side-slot elongated needle tubes to obtain longer continuous tissue strips, meeting the needs of genomic and transcriptomic studies that require a large amount of complete RNA/DNA.

Efficacy Verification

Customized services have been verified in multiple specific clinical scenarios:

  Pediatric NAFLD Research Project: Using a custom 18G ultra-fine needle, successful biopsies were conducted on 50 children aged 8-16 with NAFLD. Compared to the traditional 16G needle, both the postoperative pain score and the rate of analgesic use were significantly reduced, and all samples met the requirements for pathological diagnosis, demonstrating the feasibility and safety of using a finer needle diameter in the pediatric population.

  Obesity Patient (BMI > 40) Cohort: Using a 22cm ultra-long custom needle, successful percutaneous liver biopsies were performed on 20 severely obese patients, solving the common problem of insufficient standard needle length. The puncture success rate was 100%, and no sampling failure occurred due to insufficient puncture depth.

  Precise Biopsy of Liver Focal Lesions: In collaboration with the interventional radiology department, specific-length and more rigid needles were customized for 10 patients with small liver cancers near the hepatic hilum or the heart. Under CT guidance, precise sampling of ≤ 1cm nodules was achieved, providing a key basis for pathological diagnosis before ablation treatment.

Research and Development Strategy and Philosophy

Manners Technology's customized strategy is "from mass production to mass customization." They recognize that in the era of precision medicine, the "one-size-fits-all" approach to medical equipment is being disrupted. The philosophy is: through advanced digital design and flexible manufacturing technologies, to reduce the cost and delivery time of customization to a level that is clinically widely acceptable, so that personalization is no longer just a "privilege" for a few complex cases. They have established a "joint design partnership" with top liver disease centers and research institutions, jointly defining special clinical needs, and quickly converting these needs into product solutions. The core is to build an "agile ecosystem driven by clinical needs."

Future Outlook

The future customization will develop towards "intelligent recommendation" and "biological adaptation." The platform will integrate a "clinical decision support algorithm." Doctors only need to input the basic information of the patient (age, gender, height, weight, main diagnosis, target lesion location) and preoperative images, and the algorithm will automatically recommend the optimal combination of needle parameters based on the huge clinical database and mechanical models. Further, research is exploring the application of "biodegradable composite materials" in customized biopsy needles. For example, for diseases that require multiple biopsies for monitoring (such as rejection after liver transplantation), a needle can be customized with a needle body that can be absorbed and only the sample is retained, thereby avoiding cumulative damage to the liver capsule from multiple punctures. Ultimately, customization will not only be about size adjustment, but will encompass comprehensive personalized design of materials, functions, and even the way it interacts with the human body.