Right angle cut-off stomach perforation full layer biopsy forceps

Abstract

The present application relates to a kind of right-angle cut-in type stomach perforation full layer biopsy forceps, belong to surgical operation instrument technical field, it includes: first clamp bar and second clamp bar, two clamp bars are crossed hinged in middle part by hinged shaft and form scissors-like structure, proximal end is equipped with finger ring;First clamp cup and second clamp cup, respectively, are equipped in the distal end of first clamp bar and second clamp bar, and clamp cup is hollow hemispherical thin-walled shell;Wherein, the bottom central axis of first clamp cup and the distal end axis of first clamp bar are 120 ° to 135 ° cut-in angle α between, second clamp cup and second clamp bar have the same angle of clamping;When two clamp bars are closed, the edge of first clamp cup and second clamp cup mutually adhere to each other, form a closed spherical cavity, and the circular end face of clamp cup mutually butts is equipped with full layer cutting edge.This application enables surgeon to be able to in narrow operation field single hand precision operation, obtains sufficient complete full layer gastric wall tissue and effectively avoids perforation expansion once, significantly improves biopsy quality and surgical safety.

Description

Technical Field

[0001] This invention belongs to the field of surgical instrument technology, specifically relating to a dedicated biopsy device for open surgery or laparoscopic surgery. Background Technology

[0002] Gastric perforation is a common acute abdominal condition, often caused by diseases such as gastric ulcers and gastric tumors. Taking a biopsy of the perforation perimeter during surgery for pathological examination is of significant clinical importance in determining the cause and guiding treatment plans (including intraoperative decisions and subsequent postoperative care).

[0003] Currently, there are no specialized instruments for gastric wall tissue biopsies in clinical surgery. With existing technology, doctors typically perform the procedure using the following two methods:

[0004] ① Using standard surgical scissors (such as Mersworth scissors): The surgeon directly inserts the surgical scissors into the abdominal cavity and cuts tissue at the edge of the perforation. This method has the following inherent drawbacks: a. Limited operating angle, making it difficult to apply force precisely: Especially in areas with deep locations and narrow spaces, such as the posterior wall or antrum of the stomach, it is difficult for the cutting plane of the scissors to form an ideal angle with the surface of the stomach wall. Often, only a small amount of surface tissue can be "pecked" off, making it impossible to obtain a satisfactory full-thickness specimen in one go.

[0005] b. Small sample size and easily broken: The tissues cut are usually very small and easily fall off or are crushed by the scissors after being cut, resulting in unqualified specimens that need to be repeated.

[0006] c. High risk of iatrogenic injury: In order to obtain sufficient tissue, doctors need to repeatedly clamp and cut in a poor field of vision, which can easily tear and enlarge the originally small perforation, increasing the difficulty of subsequent repair and the risk of postoperative leakage.

[0007] ② Using laparoscopic forceps in conjunction with scissors: In laparoscopic surgery, one hand typically uses forceps to lift the stomach wall while the other hand uses scissors to cut. This method presents challenges in coordination. a. High requirements for operational coordination: Grasping and cutting require two people to work together, which places high demands on the assistant's skills. Even a slight deviation can lead to tissue slippage.

[0008] b. Limited field of vision: After the forceps lift the tissue, the cutting angle of the scissors is often blocked, making it difficult to cut the full-thickness tissue, including the mucosa, muscle layer and serosa, in one go.

[0009] c. Insufficient sampling depth: Even if the sample is successfully cut, the tissue obtained is often thin due to the limitations of the operation method, making it difficult to ensure that it contains enough muscle layer (seromuscular layer) tissue. For the differential diagnosis of the cause of gastric perforation (such as differentiating between benign ulcers and gastric cancer), observing whether cancer cells have infiltrated into the muscle layer is the gold standard for pathological diagnosis. Relying solely on mucosal layer specimens can easily lead to false negative results.

[0010] In summary, current technology lacks a specialized instrument capable of obtaining a sufficient amount of full-thickness (especially the seromuscular layer) gastric wall tissue in a single operation within a confined space, using only one hand. There is an urgent clinical need for a biopsy instrument designed specifically for gastric perforation surgery, capable of precise incision, preventing tissue detachment, and avoiding further perforation. Summary of the Invention

[0011] The purpose of this invention is to overcome the numerous inconveniences and risks associated with gastric wall biopsies performed using non-specialized instruments in existing technologies, and to provide a right-angle incision full-thickness gastric perforation biopsy forceps specifically designed for open and laparoscopic surgeries. This biopsy forceps aims to solve the problems of difficult sampling, insufficient tissue volume, inability to guarantee full-thickness tissue acquisition, and easy perforation enlargement caused by existing methods. It enables surgeons to operate with one hand, accurately locate the perforation, and obtain a sufficient amount of full-thickness gastric wall tissue in a single procedure, providing a reliable basis for pathological diagnosis while maximizing tissue protection and maintaining a clean wound surface.

[0012] To achieve the above objectives, the present invention provides a right-angle incision full-thickness biopsy forceps for gastric perforation, comprising: The first clamp and the second clamp are cross-hinged at the middle by a hinge axis to form a scissor-like structure, and a finger ring is provided at the proximal end; The first clamp cup and the second clamp cup are respectively located at the far ends of the first clamp bar and the second clamp bar. The clamp cup is a hollow hemispherical thin-walled shell. The first clamp cup has a tangent angle α of 120° to 135° between its bottom center axis and the distal axis of the first clamp bar. The second clamp cup and the second clamp bar have the same included angle. When the two clamp bars are closed, the edges of the first and second clamp cups fit together to form a closed spherical cavity. The circular end faces of the clamp cups that meet each other are provided with full-layer cutting edges.

[0013] Preferably, the cutting angle α is 120°.

[0014] Preferably, the diameter of the spherical cavity is 5 mm to 10 mm.

[0015] Preferably, the first clamp cup and the first clamp bar, and the second clamp cup and the second clamp bar are fixedly connected by integral molding or laser welding.

[0016] Preferably, the hardness of the full-layer cutting edge is HRC 50-55, and it is formed by laser cladding of cobalt-based alloy or local vacuum heat treatment process.

[0017] Preferably, the surface roughness Ra of the inner wall of the first clamp cup and the second clamp cup is ≤0.4μm.

[0018] Preferably, the first and second clamps are made of stainless steel or TC4 titanium alloy material for surgical implants conforming to YY / T 0294.1 standard.

[0019] Preferably, the hinge shaft is made of wear-resistant ceramic or high-strength stainless steel.

[0020] Preferably, the surface of the finger ring is fitted with or injection-molded with a medical-grade silicone finger sleeve.

[0021] Preferably, when the clamp cup is closed, the full-thickness cutting edge forms a continuous circular cutting edge, which generates shearing force to cut the full-thickness gastric wall tissue.

[0022] Compared with the prior art, the present invention has the following beneficial technical effects: ① Precise and efficient, with strong adaptability to difficult areas: The 120-degree right-angle cutting design allows for precise aiming and sampling with one hand even in traditionally difficult areas such as the gastric antrum and posterior gastric wall, achieving "point and shoot".

[0023] ② High specimen quality, meeting the needs of pathological diagnosis: Complete spherical full-thickness tissue is cut in one go, ensuring that it includes seromuscular tissue that is of decisive significance for etiological differential diagnosis. The specimen is large in quantity, structurally intact, and free from compression and breakage. Whether used for intraoperative frozen section or routine postoperative pathological examination, it can provide a reliable basis for diagnosis and avoid secondary biopsy or diagnostic difficulties caused by unqualified specimens.

[0024] ③ High safety and avoidance of iatrogenic damage: Closed sampling prevents tissue detachment; regular cutting wounds avoid tissue tearing, effectively prevent perforation from expanding, and reduce the risk of postoperative complications such as leakage.

[0025] ④ Easy to operate and short learning curve: The structure is simple, resembling ordinary scissors or forceps. Surgeons can master it without special training and without increasing the operation time.

[0026] ⑤ Good compatibility and multiple uses: It is suitable for both open surgery and its size design (such as the cup diameter ≤10mm) is also fully compatible with the current standard 10mm or 5mm laparoscopic puncture cannulas, and is also applicable in laparoscopic surgery. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the open state of a right-angle incision gastric perforation full-thickness biopsy forceps according to the present invention; Figure 2 This is a schematic diagram of the closed state of a right-angle incision gastric perforation full-thickness biopsy forceps according to the present invention.

[0028] Reference numerals in the attached drawings: 1. First clamp bar; 2. Second clamp bar; 3. First clamp cup; 4. Second clamp cup; 5. Hinge shaft; 6. Finger ring; 7. Spherical cavity; 8. Full-layer cutting edge. Detailed Implementation

[0029] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] This invention is mainly used in gastric perforation surgery to perform single-handed, precise positioning, and one-time full-thickness biopsy of the gastric wall tissue at the perforation edge, so as to obtain sufficient, complete, and uncompressed pathological specimens, providing reliable histological evidence for intraoperative frozen section or postoperative routine pathological examination, assisting in determining the cause of perforation (such as differentiating between benign and malignant ulcers), while avoiding perforation enlargement or tissue damage caused by biopsy operation.

[0031] The present invention discloses a right-angle incision gastric perforation full-thickness biopsy forceps, specifically a single-handed operating instrument that resembles scissors in shape. Its main structure is precisely composed of a first forceps bar 1, a second forceps bar 2, a first forceps cup 3, a second forceps cup 4, and related auxiliary components. Each component works together in structural design and functional implementation to form a dedicated medical device system that can perform precise full-thickness biopsies in a confined surgical space.

[0032] Specifically, both the first clamp 1 and the second clamp 2 adopt a slender rod-like structure and are made of stainless steel or TC4 titanium alloy, which conform to the YY / T 0294.1 standard for surgical implants. This material selection not only ensures that the instrument has sufficient mechanical strength and corrosion resistance, but also maintains appropriate lightweight characteristics while meeting biocompatibility requirements, making it easy for surgeons to hold and operate for a long time without fatigue. The two rods are cross-hinged in the middle by a hinge shaft 5, forming a typical scissor-like movable connection structure. The hinge point uses a precision hinge shaft 5 made of wear-resistant ceramic or high-strength stainless steel to ensure smooth movement, accurate positioning and no wobbling gaps of the two clamp rods during opening and closing, thereby ensuring the alignment accuracy of the distal clamp cup when it is closed.

[0033] Finger rings 6 are provided at the proximal end of the forceps bar, allowing the operator's thumb and ring finger to insert respectively. The finger rings 6 are finely polished to eliminate sharp edges and are fitted or injection molded with medical-grade silicone finger sleeves. This design significantly increases the comfort and friction during operation, enabling doctors to firmly control the opening and closing of the instrument and achieve precise force control.

[0034] At the distal end of the clamp bar, a first clamp cup 3 and a second clamp cup 4 are fixedly connected for accommodating and cutting tissue. These two clamp cups are hollow hemispherical thin-walled shells with equal diameters and their inner walls are precisely polished to a surface roughness Ra≤0.4μm. The smooth inner wall surface without sharp edges can ensure that the cut tissue specimen will not be mechanically damaged by friction, thus preserving the original morphological characteristics of the tissue to the greatest extent.

[0035] The bottom of the first clamp cup 3 is fixedly connected to the distal end of the first clamp rod 1 by integral molding or laser welding. The second clamp cup 4 is connected to the second clamp rod 2 in the same way. This rigid connection ensures effective force transmission, allowing the operating force applied by the doctor through the finger ring 6 to be accurately transmitted to the end of the clamp cup. It is particularly important to emphasize that the central axis of the bottom of the first clamp cup 3 and the corresponding distal axis of the first clamp rod 1 form a fixed angle (angle α) of 120° to 135°, with 120° being the most preferred. The second clamp cup 4 and the second clamp rod 2 also form the same angle. This key geometric feature constitutes the core innovation of this invention.

[0036] The design of the incision angle α is based on the optimization of surgical procedures and anatomical features. Targeting the curvature of the gastric wall surface in deep surgical areas such as the antrum and posterior gastric wall, an angle of 120° to 135° allows the forceps cup to be perpendicularly and stably attached to the gastric wall surface, achieving vertical incision rather than parallel scraping. This significantly reduces the requirements for operating space and angle, enabling precise biopsies even in difficult locations, while avoiding tissue tearing or perforation caused by improper angles. If traditional 0° angle instruments are used, the surgeon must twist their wrist to its limit to make the forceps head fit the tissue; if the angle is too small, the forceps head cannot naturally unfold and fit the target area after passing through the puncture card; if the angle is too large, the torque is too long, reducing operational stability. Repeated clinical verification has shown that an angle of 120°-135°, especially 120°, is the optimal geometric solution for allowing the forceps cup to be perpendicularly and stably attached to the gastric wall surface, achieving "vertical incision" rather than "parallel scraping."

[0037] When the operator grips the forceps to close the jaws, the edges of the first forceps cup 3 and the second forceps cup 4 fit tightly together, forming a complete, closed spherical cavity 7. The volume of this cavity is set according to clinical needs, preferably a spherical volume with a diameter of 5mm-10mm. This size design ensures that it can accommodate the full-thickness gastric wall tissue block containing the mucosa, submucosa, muscle layer and serosa layer required for a standard biopsy, and also ensures that the instruments can enter the abdominal cavity through a standard 5mm or 10mm laparoscopic puncture cannula, achieving universal compatibility between open surgery and laparoscopic surgery.

[0038] During the formation of the spherical cavity 7, the full-thickness cutting edges 8, located on the circular end faces where the first clamp cup 3 and the second clamp cup 4 meet, play a crucial role. These edges, after undergoing laser cladding of cobalt-based alloys or local vacuum heat treatment, achieve a hardness of HRC 50-55, forming sharp and wear-resistant continuous circular cutting edges. When the clamps close, the two edges come together to generate a uniform and powerful shearing force, sufficient to cut through the tough gastric wall tissue containing all layers of structure in one go, ensuring that the pathological specimen includes the seromuscular layer tissue, which is of decisive significance for etiological differential diagnosis. After the full-thickness cutting edges 8 cut off the tissue, the tissue block naturally falls into and is completely enclosed in the cavity, completely eliminating the possibility of the tissue slipping, being lost, or being contaminated by surrounding tissues (such as the omentum or intestines) during the process of exiting the abdominal cavity, ensuring the integrity and purity of the specimen.

[0039] The continuously closed circular cutting edge generates a uniform and powerful shearing force under gripping force, enabling a clean and precise severing of tough muscle layer tissue in a single operation. This ensures that the pathological specimen contains the crucial seromuscular layer (especially the muscle layer) tissue, which is key to determining the etiology of the disease. In cases of gastric perforation, the core pathological basis for differentiating the nature of the perforation (e.g., benign ulcer perforation vs. gastric cancer perforation) lies in observing whether cancer cells have infiltrated into the muscle layer. Only by obtaining full-thickness tissue containing the intact muscle layer can the pathologist make an accurate judgment and avoid false negative diagnoses caused by specimens that are too shallow. Since the goal of a biopsy is to directly "excavate" a regular cylindrical or spherical tissue mass, the wound edges are clean, without tearing or carbonization. This regular wound surface facilitates subsequent processing and fundamentally avoids tissue tearing and perforation enlargement that may occur when using traditional scissors.

[0040] The aforementioned components work synergistically through specific structural relationships: the fixed 120° angle between the forceps bar and the forceps cup solves the problem of vertical cutting in deep, narrow spaces, but its flat jaws cannot wrap around the fragile gastric wall tissue. The spherical cavity 7 formed by the closure of the hemispherical forceps cup solves the problem of tissue wrapping and preventing slippage, but without the 120° bar, it is impossible to apply force vertically against the gastric wall under laparoscopy. The organic combination of the two achieves the unexpected technical effect of vertical cutting and full-thickness wrapping of fragile edematous tissue in the specific scenario of gastric perforation. The hinge axis 5, as the motion hub, ensures precise alignment of the two forceps cups, the full-thickness cutting edge 8 provides reliable cutting force, and the smooth inner wall protects the integrity of the tissue. These elements work together to enable doctors to complete complex operations that traditionally require two hands with one hand, while avoiding the risk of complications such as tissue slippage and perforation enlargement.

[0041] The method of using the right-angle incision full-thickness gastric perforation biopsy forceps of this invention includes the following steps: ① Preoperative preparation: Take out the right-angle cutting gastric perforation full-thickness biopsy forceps of the present invention from the sterile packaging, and check whether the forceps jaws open and close smoothly and whether the cutting edge is intact.

[0042] ② Enter the spell field: a. Laparoscopic surgery: The jaws of the clamps are closed, and the clamp head is inserted into the abdominal cavity through a 10mm or 5mm trocar on the abdominal wall.

[0043] b. Open surgery: The biopsy forceps are directly inserted into the abdominal cavity through the surgical incision.

[0044] ③ Positioning and aiming: Under laparoscopic monitoring or direct vision, move the forceps head to the site to be biopsied at the edge of the gastric perforation. Utilizing the 120-degree angle design, adjust the angle of the forceps bar so that the end face of the closed hemispherical forceps cup is perpendicularly attached to the pre-cut gastric wall surface.

[0045] ④ Tissue Removal: Open the jaws of the forceps so that the two hemispherical forceps cups are positioned on either side of the target tissue. After confirming that the position is correct, slowly tighten the forceps bar so that the sharp edges of the two forceps cups meet, cutting through the entire thickness of the stomach wall in one go. At this point, the tissue block should fall completely into and be sealed within the spherical cavity 7.

[0046] ⑤ Specimen Removal: Keeping the forceps closed, withdraw the entire biopsy forceps from the abdominal cavity. Open the forceps externally, and a complete, spherical mass of gastric wall tissue will fall naturally from the spherical cavity 7 or can be easily removed. Immediately place it in a specimen bag or fixative for testing.

[0047] ⑥ Wound management: Observe the biopsy wound on the stomach wall, which is usually a round defect with neat edges. The doctor can take appropriate measures according to the specific situation during the operation (such as frozen section pathology results, perforation size, patient's general condition, etc.), such as direct suturing and repair, or further radical surgery according to the diagnosis of malignancy.

[0048] The fabrication process of the right-angle incision full-thickness gastric perforation biopsy forceps of this invention is as follows: ① Blank Preparation: Stainless steel or TC4 titanium alloy bars conforming to YY / T 0294.1 standard for surgical implants are selected. The integral structural components of "first clamp bar 1 and first clamp cup 3" and "second clamp bar 2 and second clamp cup 4" are manufactured using precision casting or five-axis CNC machining. Strict control is maintained during machining. a. The angle between the clamp cup and the clamp bar is 120°±1°.

[0049] b. The inner diameter of the hemispherical clamp cup is 8mm, and the wall thickness is 0.5mm.

[0050] c. The flatness error of the mating end faces of the two clamp cups is less than 0.02mm.

[0051] ② Edge treatment: The mating surfaces of the two hemispherical clamp cups are precision ground and mirror polished. Then, a layer of cobalt-based alloy is clad onto the end face using laser cladding technology or local vacuum heat treatment is performed to make the hardness of the edge area reach HRC50-55, forming a sharp and wear-resistant full-layer cutting edge.

[0052] ③ Inner wall polishing: The inner wall of the clamp cup is electrochemically or mechanically polished to make its surface roughness Ra≤0.4μm, ensuring that the excised tissue specimen will not be damaged by friction due to the rough inner wall, and to maintain the original morphology of the tissue to the greatest extent.

[0053] ④ Hinged assembly: The two machined parts are precisely positioned at the intersection, and a hinge hole is drilled and reamed. A wear-resistant ceramic or high-strength stainless steel hinge shaft 5 is installed to ensure that the two clamp cups are accurately aligned during opening and closing, and that the cutting edges fit tightly without gaps when closed.

[0054] ⑤ Finger ring 6 treatment: Grind and polish the finger ring 6 near the proximal end of the forceps bar to eliminate sharp edges, and then fit or injection mold a medical-grade silicone finger cot to increase the doctor's comfort and friction during operation.

[0055] ⑥ Cleaning and Sterilization: The assembled biopsy forceps undergo rigorous ultrasonic cleaning, degreasing, and passivation. Then, final sterilization is performed using ethylene oxide sterilization or high-temperature, high-pressure steam sterilization. Finally, the forceps are sealed and packaged in a Class 10,000 cleanroom to obtain the finished product.

[0056] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A right-angle incision gastric perforation full-thickness biopsy forceps, characterized in that, include: The first clamp (1) and the second clamp (2) are hinged together in the middle by a hinge shaft (5) to form a scissor-like structure, and a finger ring (6) is provided at the near end. The first clamp cup (3) and the second clamp cup (4) are respectively located at the far ends of the first clamp bar (1) and the second clamp bar (2). The clamp cup is a hollow hemispherical thin-walled shell. Among them, the bottom center axis of the first clamp cup (3) and the distal axis of the first clamp bar (1) form an entry angle α of 120° to 135°, and the second clamp cup (4) and the second clamp bar (2) have the same included angle; when the two clamp bars are closed, the edges of the first clamp cup (3) and the second clamp cup (4) fit together to form a closed spherical cavity (7), and the circular end faces of the clamp cups that meet each other are provided with full-layer cutting edge (8).

2. The right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, The angle of entry α is 120°.

3. The right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, The diameter of the spherical cavity (7) is 5 mm to 10 mm.

4. The right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, The first clamp cup (3) and the first clamp bar (1), and the second clamp cup (4) and the second clamp bar (2) are fixedly connected by integral molding or laser welding.

5. The right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, The hardness of the full-layer cutting edge (8) is HRC 50-55, and it is formed by laser cladding of cobalt-based alloy or local vacuum heat treatment process.

6. The right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, The inner wall surface roughness Ra of the first clamp cup (3) and the second clamp cup (4) is ≤0.4μm.

7. The right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, The first clamp (1) and the second clamp (2) are made of stainless steel or TC4 titanium alloy material for surgical implants conforming to YY / T 0294.1 standard.

8. The right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, The hinge shaft (5) is made of wear-resistant ceramic or high-strength stainless steel.

9. A right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, The surface of the finger ring (6) is fitted or injection molded with a medical-grade silicone finger sleeve.

10. A right-angle incision full-thickness gastric perforation biopsy forceps according to claim 1, characterized in that, When the clamp cup is closed, the full-thickness cutting edge (8) forms a continuous circular cutting edge, which generates shearing force to cut the full-thickness gastric wall tissue.

Images