Recently, Peking Union Medical College Hospital released a public notice on the transformation of scientific and technological achievements, indicating that the hospital intends to transfer patent rights through assignment."An Endoscopic Biopsy Forceps"The relevant patents are transferred to industry partners for use, with a total transfer amount of RMBRMB 2 million. The inventor of this patented technology isProfessor Wu Xi and His Team。
Wu Xi:Associate Chief Physician, Professor, and Master’s Supervisor in the Department of Gastroenterology at Peking Union Medical College Hospital, with over ten years of experience in the clinical diagnosis and treatment of digestive system diseases. She specializes in endoscopic diagnosis and minimally invasive therapy for early gastrointestinal cancers (such as early gastric cancer) and complex pancreatobiliary disorders (such as cholelithiasis and pancreatitis). She led the development of the MPHD model for predicting deep submucosal invasion in early gastric cancer and participated in research on integrated diagnostic and therapeutic techniques for pancreatic cancer complicated by obstructive jaundice. As a young committee member of the Chinese Society of Digestive Endoscopology and a member of several other academic organizations, she has performed multiple live endoscopic demonstrations at academic conferences such as the 2015 PUMC International Forum on Digestive Diseases, promoting the standardized application of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). By 2024, her participatory research confirmed that the integration of EUS-FNA and ERCP techniques could increase the pathological diagnosis rate of pancreatic cancer to92.50%。
The present invention is a medical device for diagnostic purposes, the core function of which is to precisely biopsy tissue from the inner walls of human body lumens (such as the bile duct, esophagus, cardia, pylorus, and intestines) under endoscopic monitoring, thereby providing pathological samples to support disease diagnosis (such as detection of pathological tissues and cancer screening).
Biopsy of the inner lining tissues of human body lumens (such as the bile duct, esophagus, cardia, pylorus, and intestines) is a critical method for disease diagnosis. In scenarios involving space-occupying lesions and inflammation screening, the precise acquisition of tissue samples directly determines diagnostic accuracy. Clinically, conditions such as obstructive jaundice caused by space-occupying lesions in the bile duct, or mucosal lesions in the esophagus or intestines, require tissue sampling using endoscopic biopsy forceps for pathological analysis, thereby providing a core basis for formulating treatment plans.
These patients require endoscopic monitoring, assisted byBiopsy ForcepsObtaining tissue samples from deep within the lumen. For instance, in patients with obstructive jaundice, biopsies guided by endoscopic retrograde cholangiopancreatography (ERCP) are required to determine the nature of space-occupying lesions; during early esophageal cancer screening, precise sampling of suspicious mucosal areas is necessary to rule out pathological changes. The sampling efficiency and specimen quality of biopsy forceps directly impact the timeliness and accuracy of subsequent diagnosis, constituting a critical link in the clinical diagnostic and treatment workflow.
Currently, traditional endoscopic biopsy forceps used in clinical practice have significant design flaws, leading to multiple bottlenecks in tissue sampling. On one hand, the jaws of traditional biopsy forceps typically open forward, allowing sampling only from the "upstream" side of the tissue. If the lesion is covered by normal epithelium, or if the lumen is obstructed by pathological tissue leaving minimal space for maneuvering, the jaws may fail to open due to tissue compression. This makes it difficult to obtain lesion tissue through a forward approach, resulting in a lower positive detection rate in some cases. On the other hand, traditional biopsy forceps lack targeted structural designs, making samples prone to detachment during collection. Furthermore, they are not adaptable to different types of pathological scenarios—for special cases such as eccentric lesions or seamless tissues, the existing symmetric, fixed-structure jaws struggle to accurately capture samples.
Furthermore, some traditional biopsy forcepsNo guidewire channel set, insufficient operational accuracy in complex luminal environments makes it easy to deviate from the target sampling area; meanwhile, the lack of flexibility in adjusting the opening and closing force of the forceps jaws either results in sample damage due to insufficient gripping force or causes injury to normal tissue due to excessive force, further compromising diagnostic efficacy. These issues lead to high difficulty and low efficiency in clinical biopsy procedures, with some patients requiring multiple biopsies to obtain adequate samples, which not only increases the medical burden but may also delay treatment timing. There is an urgent need for a new type of endoscopic biopsy forceps that is adapted to complex pathological scenarios, offers ease of operation, and ensures precise sampling to address these challenges.
To address the clinical pain points of traditional endoscopic biopsy forceps, such as sampling limitations and operational complexity, Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences has developed"New Endoscopic Biopsy Forceps", with“Reverse Sampling + Multi-Functional Adaptation”As a core innovation, structural optimization and functional upgrades have enabled the development of an integrated solution featuring “efficient sampling, precise manipulation, and flexible adaptability,” significantly optimizing the technical approach for endoluminal wall biopsy and enhancing the clinical operational experience.
The core technological breakthrough of this product lies inReverse-Opening and Closing Forceps Tip Design, fundamentally resolving the spatial limitations inherent in conventional forward-opening biopsy forceps. Traditional biopsy forceps, whose jaws open anteriorly, often fail to effectively acquire target samples when the lumen is obstructed by pathological tissue or when lesions are covered by normal epithelium. In contrast, this novel biopsy forceps employs a unique linkage transmission mechanism that positions the pivotal connection points of the first and second jaws at the distal end of the base. As the operating slider moves distally, the jaws pivot outward from the base’s distal end, achieving a reverse-opening action. During sampling, the closed jaw tip can be advanced through the lesion to a position downstream; the jaws are then opened, and upon withdrawal, the natural compression of the tissue facilitates the entry of the pathological tissue between the jaws, thereby enabling reverse hooking or excision.
This mechanism not only overcomes sampling obstacles in narrow or obstructed lumens, significantly increasing the positive detection rate for occult or obstructive lesions, but also simplifies the operational procedure by avoiding forced opening of the forceps jaws in confined spaces, thereby reducing procedural difficulty and the risk of injury to normal tissue.
Secondly,Multifunctional Structural DesignSignificantly improves sampling precision and stability. The first and second mating surfaces of the jaw head feature complementary serrated shapes, enabling firm clamping of the specimen upon closure and effectively preventing sample dislodgement during sampling. Meanwhile, cavities are provided on the inner sides of the jaw claws, forming an independent specimen containment space when closed. This allows for the collection of larger-volume tissue samples with intact structure, providing more sufficient basis for pathological diagnosis. A slot structure is provided at the end of the base to accommodate the linkage assembly, resulting in a more compact overall design that both reduces space occupation within the lumen and prevents interference between moving parts.
Furthermore,The operating rod and the flexible cannula are designed with a rotatable fit., physicians can flexibly adjust the orientation of the forceps tip by rotating the control lever to precisely align with the target area, thereby further enhancing sampling accuracy. Some models also integrate a guidewire channel, allowing a guidewire to be inserted first as a guide in complex anatomical pathways (such as curved lumens like the bile ducts and intestines), and then advancing the biopsy forceps along the guidewire to the target location. This approach significantly improves positioning precision and reduces operational deviation.
To further expand clinical applicability, this biopsy forceps adopts a flexible design concept adaptable to multiple scenarios. Targeting different lesion characteristics,Multiple Jaw Configurations Available:Bowl-shaped forceps jaws facilitate automatic tissue engagement during withdrawal; tapered forceps jaws are suitable for puncture sampling of gapless or dense tissues; the asymmetric structure is specifically designed for eccentric lesions, ensuring effective grasping of asymmetrically distributed pathological foci.
Equally important is the linkage mechanism between the slip ring and the transmission guide wire, which allows physicians to flexibly adjust the jaw opening and clamping force by controlling the displacement of the slip ring based on tissue hardness and lesion characteristics. This ensures sufficient grip to prevent sample loss while avoiding excessive force that could damage healthy tissue. Featuring a compact structure and a highly flexible sheath design, the device can smoothly pass through standard endoscopic working channels and is compatible with human lumens of varying diameters, providing a unified and efficient solution for biopsies of lesions in multiple sites, including the esophagus, cardia, pylorus, intestines, and bile ducts.
As a core instrument for diagnosing tissues on the inner walls of body cavities, endoscopic biopsy forceps are experiencing sustained growth in market demand. In response to pain points associated with traditional products, such as limited sampling capability and complex operation, domestic and international enterprises are actively pursuing technological innovations. This has fostered a competitive landscape characterized by “structural optimization and upgrades + precise adaptation to clinical scenarios,” with public information corroborating the progress of related product research, development, and commercialization.
In the field of endoscopic biopsy forceps,Cook MedicalWithCaptura® Seriescentered on addressing niche clinical scenarios with diverse requirements. Among these, the Captura Mini biopsy forceps are designed for “ultra-narrow channel compatibility,” featuring a 1.8-mm cup diameter and a 160-cm sheath length, enabling operation through endoscopic accessory channels as small as 2.0 mm. This makes them suitable for tissue sampling in narrow lumens such as the esophagus and biliary tract. The surgically graded cup edge design minimizes tissue trauma, while the non-spiked structure prevents inadvertent snagging of surrounding tissues during sample collection.
The Captura Pro™ biopsy forceps offer a range of specifications, with cup diameters ranging from 2.2 mm (Standard) to 3.3 mm (Max), and sheath lengths spanning 160 cm to 230 cm. Certain models feature a spiked design to securely grasp softer mucosal tissues and prevent sample loss. The unique dual-drive wire mechanism, combined with a short-stroke operating handle, enhances the stability of jaw opening and closing as well as operational efficiency, meeting biopsy needs across multiple sites including the gastrointestinal and respiratory tracts.
In addition, Cook Medical has launched the Captura hot biopsy forceps, which support 360° rotational adjustment. This device enables electrocoagulation hemostasis during sampling, thereby reducing the risk of intraoperative bleeding. Its transparent plastic jaw design allows physicians to visually confirm sample collection, further ensuring sampling accuracy.
Jiuhong MedicalIt is one of the earliest enterprises in China to develop disposable biopsy forceps. The company focuses on endoscopic interventional medical devices.Jiuhong Biopsy ForcepsIt is a single-use medical device specifically designed for collecting tissue samples from lesions in the digestive and respiratory tracts during endoscopic procedures such as gastroscopy and colonoscopy. Its design features a long, slender handle with a distal forceps jaw that is advanced through the working channel of the endoscope; the jaws can open and close to acquire tissue specimens, ensuring precise and safe operation.
This biopsy forceps features a medical-grade stainless steel jaw, laser welding technology, and a rigid four-bar linkage structure to enhance sampling efficiency and reliability. Certain models (e.g., the JHY-FB series) incorporate an outer spring tube with a plastic coating to minimize damage to the endoscope’s instrument channel, and are supplied sterile, eliminating the need for re-sterilization prior to use. Standard specifications cover various lengths (e.g., 1050 mm to 2600 mm) and diameters (e.g., 1.8 mm, 2.3 mm), compatible with different endoscope instrument channel sizes (e.g., 2.0 mm or 2.8 mm).