Official Release of Achievements

To mark the 65th anniversary of the invention of the Menghini liver biopsy needle, Manners Technology, in collaboration with multiple international associations for liver diseases, released the White Paper on Menghini Needle Technology: Past, Present and Future. The white paper systematically reviews the milestone‑based evolution of this technology since its birth in 1958, and unveils next‑generation conceptual prototypes based on bioabsorbable materials and micro‑robot‑driven systems for the first time. Clinical data shows that modern‑manufacturing‑optimised Menghini needles, while retaining the essence of their classic suction principle, have reduced the major complication rate from an early 1–3 % to below 0.5 %, continuously consolidating their status as the "gold‑standard" tool for liver pathological diagnosis.

R&D Background and Clinical Pain Points

The classic Menghini needle design (a blunt‑tipped cannula with side holes paired with syringe suction) has endured for more than half a century, proving the superiority of its core principle. Its evolution has always revolved around balancing and optimising several eternal trade‑offs:

  Minimising trauma while optimising sampling: How to obtain more intact and representative tissue cores using finer‑gauge needles?

  Balancing procedural simplicity with controllable precision: How to render this relatively "blind" procedure more visualised and controllable?

  Universal adaptability for diverse scenarios: How to adapt the same principle to a full spectrum of conditions, from infants to adults, and from fatty liver to cirrhosis?These contradictions drive continuous technological iteration.

Core Technological Innovations

From classic to modern designs, the evolution of the Menghini needle is reflected in continuous multi‑layered innovation:

  Generational upgrades in materials and manufacturing: From early conventional stainless steel to 316L medical‑grade stainless steel, and further to today's maraging steel and titanium alloy; manufacturing processes have advanced from lathe machining and grinding to CNC machining, laser cutting and electropolishing. Each upgrade in materials and processes delivers sharper, stronger and smoother needles, directly boosting biopsy success rates and safety.

  Continuous optimisation of design details: Classic Menghini needles feature purely metallic blunt tips. Modern designs optimise tip geometry (e.g., specific bevel angles and edge radii), increase the number and layout of side holes to improve tissue capture efficiency, and integrate safety locking devices to prevent accidental needlestick injuries. Accumulated refinements in these details significantly enhance user experience.

  From standalone tool to integrated system: The greatest evolution is the shift from a single needle to a system including dedicated puncture guides, integrated negative‑pressure devices, visualisation modules and depth‑control units. This enables seamless integration of the classic Menghini principle with imaging‑guided technologies such as ultrasound and CT, transitioning from blind puncture to precision image‑guided biopsy.

Mechanism of Action

The core of technological evolution lies in continuously enhancing its inherent advantages of "gentle and efficient tissue acquisition" while overcoming inherent limitations:

Superior materials and manufacturing directly reduce puncture resistance and tissue crush injury, yielding samples closer to in‑vivo conditions and improving the accuracy of pathological diagnosis.

Systematic integration standardises procedural workflows. For instance, integrated negative‑pressure devices ensure consistent suction pressure each time, eliminating fluctuations in sample quality caused by variations in manual operation. Imaging guidance fundamentally solves positioning challenges, enabling the tip to precisely target specific liver segments or even focal lesions.

The addition of safety features such as needle‑tip sheaths, which automatically or manually cover sharp ends after needle withdrawal from the body, protects healthcare workers and reflects the pursuit of comprehensive safety in modern medical devices.

Efficacy Validation

Decades‑long widespread application and continuous refinement have extensively validated the efficacy and safety of modern Menghini needles:

  Gold‑standard diagnostic performance: Despite advances in non‑invasive diagnostic techniques such as transient elastography, histological examination via liver biopsy remains the gold standard for diagnosing and staging liver fibrosis, grading steatosis, assessing inflammatory activity, and identifying the aetiology of many liver diseases. The Menghini needle is one of the most commonly used tools to implement this standard.

  Continuous safety improvements: Large‑scale retrospective studies show that with modern ultrasound guidance and optimised needle designs, the incidence of major complications (e.g., severe bleeding) from percutaneous liver biopsy has fallen below 0.5 %, with an extremely low mortality rate (approximately 0.01 %), rendering it a relatively safe procedure.

  Long‑term technical viability: Compared with later‑developed cutting biopsy guns, the suction principle of Menghini needles is often considered superior in terms of the length and integrity of obtained liver tissue cores. Particularly for evaluating diffuse liver diseases such as viral hepatitis and fatty liver, it remains the first choice in many top‑tier liver disease centres.

R&D Strategy and Philosophy

The inheritance and innovation of the Menghini needle embody an R&D philosophy of constant core principle with iterative implementation methods. Manufacturers deeply understand and respect the simple yet highly effective physical logic (negative‑pressure suction cutting) embedded in its classic design. Innovation aims not to subvert this principle, but to amplify and refine it using state‑of‑the‑art contemporary materials, engineering and digital technologies, while addressing era‑specific limitations in visualisation, controllability and safety. Its core belief is: a true classic is not a fossil confined to museums, but a living entity that continuously absorbs new technological nutrients to remain dynamic.

Future Outlook

Future evolution of the Menghini needle will focus on intelligence, minimal invasiveness and integrated diagnosis‑and‑therapy.

  Intelligent sensing and navigation: Next‑generation needles may integrate miniature fibre‑optic sensors or impedance spectrometers to analyse contacted tissue types in real time during puncture, distinguishing fat, fibrosis or normal liver parenchyma, and even preliminarily identifying tumour cells to enable in‑situ pathological analysis.

  Robot‑assisted precision puncture: Combined with micro‑robotics, actively compliance‑controlled biopsy needles will be developed. Guided by imaging systems, they can automatically bypass blood vessels, reach targets via optimal trajectories, and maintain stable positioning during sampling, greatly improving biopsy precision for deep small lesions.

  Bioabsorbable and targeted sampling: Research will explore needle bodies fabricated from bioabsorbable polymers. After sampling, the needle safely degrades in vivo, leaving only a tiny tract, greatly reducing patient discomfort and allowing more frequent monitoring biopsies. Further research will investigate drug‑loaded tips to realise simultaneous biopsy and local therapy.

  Integration with non‑invasive technologies: In the future, Menghini biopsy may no longer be a standalone procedure, but deeply integrated with multiparametric MRI and AI‑powered imaging analysis. AI first precisely delineates high‑risk "suspicious areas" requiring biopsy via non‑invasive imaging, then guides robotic Menghini needles for targeted verification, forming a closed loop of "non‑invasive screening‑precision biopsy".

Beginning with a simple innovative concept in 1958, the story of the Menghini liver biopsy needle is far from over. It will continue to serve as a critical bridge linking clinical practice and pathology, the macro and the micro. In the era of precision medicine, with greater intelligence, safety and accuracy, it will safeguard human liver health.