Based on in‑depth insights into clinical pain points of liver biopsy, Manners Technology has launched the SafeCore Menghini Liver Biopsy Needle System. Beyond the needle itself, this system innovatively integrates a visual negative‑pressure monitoring window and an adjustable depth stop. Multicentre clinical studies confirm that with this system, the success rate of obtaining sufficient diagnostic tissue on the first puncture has risen from 85 % to 96 %, while the incidence of minor puncture‑related complications (e.g., pain, transient hypotension) has decreased by 40 %. This marks the evolution of Menghini needle design from a mere sampling tool to a patient‑safety‑centred diagnosis‑and‑treatment system.

R&D Background and Clinical Pain Points

Despite the superior suction principle of Menghini needles, human‑factors‑engineering‑related pain points persist in real‑world clinical practice that affect procedural success and safety:

  Uncertainty of "blind suction": Operators cannot directly visualise whether tissue has been aspirated into the cannula or if the tissue volume is adequate. Reliance on tactile feedback or repeated suction increases risks of tissue fragmentation and bleeding.

  Experience‑dependent puncture‑depth control: Too shallow penetration may only acquire sub‑capsular tissue with no diagnostic value; excessive depth raises risks of injuring large blood vessels or bile ducts, especially in patients with shrunken or morphologically abnormal livers.

  Cumbersome workflow: Conventional steps of syringe suction, connection and fixation are inconvenient to perform under sterile drapes, reducing efficiency and increasing contamination risks.

  Patient anxiety and pain: Prolonged preparation and uncertain procedures heighten patient stress, which may lower compliance and compromise puncture safety.

Core Technological Innovations

Starting from the full clinical workflow, the manufacturer has carried out human‑centred systematic design innovations:

  Real‑time visualisation via transparent window: A segment of medical‑grade highly transparent polymer window is seamlessly integrated into the proximal cannula. While maintaining negative pressure, operators can directly observe the real‑time process of liver tissue samples being aspirated into and filling the cannula, shifting from blind manipulation to visualised operation.

  Adjustable intelligent depth stop: A slidable and lockable depth‑limiting device is developed. Prior to puncture, operators can preset the penetration depth based on pre‑operative patient imaging (e.g., ultrasound‑measured distance from skin to liver capsule). The stop delivers distinct tactile and audible "click" feedback when the needle reaches the preset depth, preventing over‑penetration.

  Integrated rapid negative‑pressure generation system: Replacing conventional separate syringes, an integrated pre‑pressurised handle is designed. Standardised optimal negative pressure (typically 3–5 mL empty‑syringe negative pressure) can be instantly generated and locked by simply pulling the inner slider in the handle backward to a locking position with one hand, simplifying operation and minimising contamination risks.

Mechanism of Action

These designs directly improve procedural safety and success rates through real‑time feedback, physical constraints and workflow optimisation:

The transparent observation window eliminates key operational uncertainties. Operators can visually confirm successful tissue capture and instantly judge sample adequacy or the need for adjustments based on the length and appearance of aspirated tissue cores (e.g., integrity, visible haemorrhage). This reduces unnecessary repeated suction and lowers risks of bleeding and pain from multiple punctures.

The adjustable depth stop converts individualised imaging‑based measurements into a physical safety barrier during operation. It enforces penetration depth within safe thresholds, particularly protecting patients with small livers, positional variations or massive ascites from injury to vital structures such as the retrohepatic inferior vena cava.

The integrated negative‑pressure handle standardises and streamlines operation. Pre‑set standardised negative pressure avoids insufficient pressure (sampling failure) or excessive pressure (tissue fragmentation) caused by inconsistent suction force among operators. Rapid one‑hand operation shortens total procedural time from positioning to puncture completion, reducing liver displacement due to poor breath‑holding and lessening operator fatigue from prolonged posture maintenance.

Efficacy Validation

A prospective, single‑blind, randomised controlled study of the SafeCore system was conducted among 500 patients with varying stages of liver disease (ranging from fatty liver to cirrhosis).

  First‑puncture success rate: The experimental group using the visualised system achieved a 96.2 % success rate in obtaining intact tissue cores ≥ 1.5 cm on the first puncture, significantly higher than 84.6 % in the conventional blind‑procedure control group.

  Puncture‑depth accuracy: Post‑operative ultrasound measurements of actual penetration depth showed depth errors within ± 2 mm in the adjustable‑stop group, compared with errors exceeding ± 5 mm in the non‑stop group.

  Patient experience and complications: Intra‑procedural Numerical Rating Scale (NRS) pain scores and 24‑hour post‑operative analgesia requirements were significantly lower in the experimental group. Major complications (intervention‑required bleeding, pneumothorax, etc.) were rare in both groups with no statistically significant differences, yet the experimental group presented a lower incidence of minor complications such as puncture‑site pain and vagal reactions.

  Operator learning curve: Junior physicians using the system achieved success and safety metrics comparable to those of senior specialists more rapidly, shortening training cycles.

R&D Strategy and Philosophy

Manners Technology's clinical design philosophy is "embedding safety and ease of use into devices". It firmly believes that superior medical devices should compensate for limitations in clinical environments and disparities in operator experience. Its R&D team adopts an immersive clinical observation approach, deploying engineers in operating rooms long‑term to record full workflow details of liver biopsy, habitual operator difficulties and real‑time patient responses. Collaborating with human‑factors‑engineering experts, the team translates observed pain points into concrete design inputs. The core principle is "design eliminates errors": physical device design and interaction logic guide or even enforce operators to perform the safest and most effective procedures, minimising the potential for human error.

Future Outlook

Future clinical design will evolve toward greater contextual intelligence and personalised adaptability. Next‑generation Menghini needle systems may integrate pressure‑sensing feedback, where the handle delivers vibration alerts at varying frequencies when the tip penetrates the liver capsule or encounters abnormally hard nodules. Further ahead, wireless connectivity with ultrasound devices will enable real‑time estimation of tip positions on ultrasound screens (based on insertion‑angle and depth‑sensor data), realising virtual navigation. For customisation, future personalised puncture guide sheaths fully matching patients' intercostal anatomical structures may be manufactured via 3D printing based on 3D‑reconstructed CT or MRI models, for use with standard Menghini needles to achieve ultimate precision and safety. The ultimate goal is to transform liver biopsy from a highly experience‑dependent technique into a standardised, visualised and navigable precise interventional procedure.